Side effects of invega

Contents

Invega

SIDE EFFECTS

Overall Adverse Reaction Profile

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased mortality in elderly patients with dementia-related psychosis
  • Cerebrovascular adverse reactions, including stroke, in elderly patients with dementia-related psychosis
  • Neuroleptic malignant syndrome
  • QT prolongation
  • Tardive dyskinesia
  • Metabolic changes
  • Hyperprolactinemia
  • Potential for gastrointestinal obstruction
  • Orthostatic hypotension and syncope
  • Falls
  • Leukopenia, neutropenia, and agranulocytosis
  • Potential for cognitive and motor impairment
  • Seizures
  • Dysphagia
  • Suicide
  • Priapism
  • Thrombotic thrombocytopenic purpura (TTP)
  • Disruption of body temperature regulation
  • Antiemetic effect
  • Increased sensitivity in patients with Parkinson’s disease or those with dementia with Lewy bodies
  • Diseases or conditions that could affect metabolism or hemodynamic responses

The most common adverse reactions in clinical trials in adult subjects with schizophrenia (reported in 5% or more of subjects treated with INVEGA® and at least twice the placebo rate in any of the dose groups) were extrapyramidal symptoms, tachycardia, and akathisia. The most common adverse reactions in clinical trials in adult patients with schizoaffective disorder (reported in 5% or more of subjects treated with INVEGA® and at least twice the placebo rate) were extrapyramidal symptoms, somnolence, dyspepsia, constipation, weight increased, and nasopharyngitis.

The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizophrenia (causing discontinuation in 2% of INVEGA®-treated subjects) were nervous system disorders. The most common adverse reactions that were associated with discontinuation from clinical trials in adult subjects with schizoaffective disorder were gastrointestinal disorders, which resulted in discontinuation in 1% of INVEGA®-treated subjects. .

The safety of INVEGA® was evaluated in 1205 adult subjects with schizophrenia who participated in three placebo-controlled, 6-week, double-blind trials, of whom 850 subjects received INVEGA® at fixed doses ranging from 3 mg to 12 mg once daily. The information presented in this section was derived from pooled data from these three trials. Additional safety information from the placebo-controlled phase of the long-term maintenance study, in which subjects received INVEGA® at daily doses within the range of 3 mg to 15 mg (n=104), is also included.

The safety of INVEGA® was evaluated in 150 adolescent subjects 12-17 years of age with schizophrenia who received INVEGA® in the dose range of 1.5 mg to 12 mg/day in a 6-week, double-blind, placebo-controlled trial.

The safety of INVEGA® was also evaluated in 622 adult subjects with schizoaffective disorder who participated in two placebo-controlled, 6-week, double-blind trials. In one of these trials, 206 subjects were assigned to one of two dose levels of INVEGA®: 6 mg with the option to reduce to 3 mg (n=108) or 12 mg with the option to reduce to 9 mg (n=98) once daily. In the other study, 214 subjects received flexible doses of INVEGA® (3-12 mg once daily). Both studies included subjects who received INVEGA® either as monotherapy or as an adjunct to mood stabilizers and/or antidepressants. Adverse events during exposure to study treatment were obtained by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of INVEGA® (adverse drug reactions) based on the comprehensive assessment of the available adverse event information. A causal association for INVEGA® often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials – Schizophrenia In Adults And Adolescents

Adult Patients With Schizophrenia

Table 4 enumerates the pooled incidences of adverse reactions reported in the three placebo-controlled, 6-week, fixed-dose studies in adults, listing those that occurred in 2% or more of subjects treated with INVEGA® in any of the dose groups, and for which the incidence in INVEGA®-treated subjects in any of the dose groups was greater than the incidence in subjects treated with placebo.

Table 4: Adverse Reactions Reported by ≥ 2% of INVEGA®-Treated Adult Subjects with Schizophrenia in Three Short-Term, Fixed-Dose, Placebo-Controlled Clinical Trials*

Body System or Organ Class
Dictionary-Derived Term
Placebo
(N=355)
Percentage of Patients
3 mg once daily
(N=127)
INVEGA® 6 mg once daily
(N=235)
9 mg once daily
(N=246)
12 mg once daily
(N=242)
Total percentage of subjects with adverse reactions 37 48 47 53 59
Cardiac disorders
Atrioventricular block first degree 1 2 0 2 1
Bundle branch block 2 3 1 3 <1
Sinus arrhythmia 0 2 1 1 <1
Tachycardia 7 14 12 12 14
Gastrointestinal disorders
Abdominal pain upper 1 1 3 2 2
Dry mouth 1 2 3 1 3
Salivary hypersecretion <1 0 <1 1 4
General disorders
Asthenia 1 2 <1 2 2
Fatigue 1 2 1 2 2
Nervous system disorders
Akathisia 4 4 3 8 10
Dizziness 4 6 5 4 5
Extrapyramidal symptoms 8 10 7 20 18
Headache 12 11 12 14 14
Somnolence 7 6 9 10 11
Vascular disorders
Orthostatic hypotension 1 2 1 2 4
* Table includes adverse reactions that were reported in 2% or more of subjects in any of the INVEGA® dose groups and which occurred at greater incidence than in the placebo group. Data are pooled from three studies; one study included once-daily INVEGA® doses of 3 mg and 9 mg, the second study included 6 mg, 9 mg, and 12 mg, and the third study included 6 mg and 12 mg . Extrapyramidal symptoms includes the terms dyskinesia, dystonia, extrapyramidal disorder, hypertonia, muscle rigidity, oculogyration, parkinsonism, and tremor. Somnolence includes the terms sedation and somnolence. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased. Adverse reactions for which the INVEGA® incidence was equal to or less than placebo are not listed in the table, but included the following: vomiting.

Adolescent Patients With Schizophrenia

Table 5 lists the adverse reactions reported in a fixed-dose, placebo-controlled study in adolescent subjects 12-17 years of age with schizophrenia, listing those that occurred in 2% or more of subjects treated with INVEGA® in any of the dose groups, and for which the incidence in INVEGA®-treated subjects in any of the dose groups was greater than the incidence in subjects treated with placebo.

Table 5: Adverse Reactions Reported by ≥ 2% of INVEGA®-Treated Adolescent Subjects with Schizophrenia in a Fixed-Dose, Placebo-Controlled Clinical Trial*

Body System or Organ Class
Dictionary-Derived Term
Placebo
(N=51)
Percentage of Patients
1.5 mg once daily
(N=54)
INVEGA® 3 mg once daily
(N=16)
6 mg once daily
(N=45)
12 mg once daily
(N=35)
Total percentage of subjects with adverse reactions 43 37 50 58 74
Cardiac disorders
Tachycardia 0 0 6 9 6
Eye disorders
Vision blurred 0 0 0 0 3
Gastrointestinal disorders
Dry mouth 2 0 0 0 3
Salivary hypersecretion 0 2 6 2 0
Swollen tongue 0 0 0 0 3
Vomiting 10 0 6 11 3
General disorders
Asthenia 0 0 0 2 3
Fatigue 0 4 0 2 3
Infections and infestations
Nasopharyngitis 2 4 0 4 0
Investigations
Weight increased 0 7 6 2 3
Nervous system disorders
Akathisia 0 4 6 11 17
Dizziness 0 2 6 2 3
Extrapyramidal symptoms 0 4 19 18 23
Headache 4 9 6 4 14
Lethargy 0 0 0 0 3
Somnolence 4 9 13 20 26
Tongue paralysis 0 0 0 0 3
Psychiatric disorders
Anxiety 4 0 0 2 9
Reproductive system and breast disorders
Amenorrhea 0 0 6 0 0
Galactorrhea 0 0 0 4 0
Gynecomastia 0 0 0 0 3
Respiratory, thoracic and mediastinal disorders
Epistaxis 0 0 0 2 0
* Table includes adverse reactions that were reported in 2% or more of subjects in any of the INVEGA® dose groups and which occurred at greater incidence than in the placebo group. Extrapyramidal symptoms includes the terms oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, muscle contractions involuntary, parkinsonian gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia. Insomnia includes the terms insomnia and initial insomnia. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased. Hypertension includes the terms hypertension and blood pressure increased. Gynecomastia includes the terms gynecomastia and breast swelling.

Commonly-Observed Adverse Reactions In Double-Blind, Placebo-Controlled Clinical Trials – Schizoaffective Disorder In Adults

Table 6 enumerates the pooled incidences of adverse reactions reported in the two placebo-controlled 6-week studies in adult subjects, listing those that occurred in 2% or more of subjects treated with INVEGA® and for which the incidence in INVEGA®-treated subjects was greater than the incidence in subjects treated with placebo.

Table 6: Adverse Drug Reactions Reported by ≥ 2% of INVEGA®-Treated Adult Subjects with Schizoaffective Disorder in Two Double-Blind, Placebo-Controlled Clinical Trials *

Body System or Organ Class
Dictionary-Derived Term
Placebo
(N=202)
Percentage of Patients
INVEGA® 3-6 mg once-daily fixed-dose range
(N=108)
INVEGA® 9-12 mg once-daily fixed-dose range
(N=98)
INVEGA® 3-12 mg once-daily flexible dose
(N=214)
Total percentage of subjects with adverse reactions 32 48 50 43
Cardiac disorders
Tachycardia 2 3 1 2
Gastrointestinal disorders
Abdominal 1 1 0 3
discomfort/Abdominal pain upper
Constipation 2 4 5 4
Dyspepsia 2 5 6 6
Nausea 6 8 8 5
Stomach discomfort 1 0 1 2
General disorders
Asthenia 1 3 4 <1
Infections and Infestations
Nasopharyngitis 1 2 5 3
Rhinitis 0 1 3 1
Upper respiratory tract infection 1 2 2 2
Investigations
Weight increased 1 5 4 4
Metabolism and nutrition disorders
Decreased appetite <1 1 0 2
Increased appetite <1 3 2 2
Musculoskeletal and connective tissue disorders
Back pain 1 1 1 3
Myalgia <1 2 4 1
Nervous system disorders
Akathisia 4 4 6 6
Dysarthria 0 1 4 2
Extrapyramidal symptoms 8 20 17 12
Somnolence 5 12 12 8
Psychiatric disorders
Sleep disorder <1 2 3 0
Respiratory, thoracic and mediastinal disorders
Cough 1 1 3 1
Pharyngolaryngeal pain <1 0 2 1
* Table includes adverse reactions that were reported in 2% or more of subjects in any of the INVEGA® dose groups and which occurred at greater incidence than in the placebo group. Data are pooled from two studies. One study included once-daily INVEGA® doses of 6 mg (with the option to reduce to 3 mg) and 12 mg (with the option to reduce to 9 mg). The second study included flexible once-daily doses of 3 to 12 mg. Among the 420 subjects treated with INVEGA®, 230 (55%) received INVEGA® as monotherapy and 190 (45%) received INVEGA® as an adjunct to mood stabilizers and/or antidepressants. Extrapyramidal symptoms includes the terms bradykinesia, drooling, dyskinesia, dystonia, hypertonia, muscle rigidity, muscle twitching, oculogyration, parkinsonian gait, parkinsonism, restlessness, and tremor. Somnolence includes the terms sedation and somnolence. Tachycardia includes the terms tachycardia, sinus tachycardia, and heart rate increased.

Monotherapy Versus Adjunctive Therapy

The designs of the two placebo-controlled, 6-week, double-blind trials in adult subjects with schizoaffective disorder included the option for subjects to receive antidepressants (except monoamine oxidase inhibitors) and/or mood stabilizers (lithium, valproate, or lamotrigine). In the subject population evaluated for safety, 230 (55%) subjects received INVEGA® as monotherapy and 190 (45%) subjects received INVEGA® as an adjunct to mood stabilizers and/or antidepressants. When comparing these 2 subpopulations, only nausea occurred at a greater frequency (≥ 3% difference) in subjects receiving INVEGA® as monotherapy.

Discontinuations Due To Adverse Reactions

Schizophrenia Trials

The percentages of subjects who discontinued due to adverse reactions in the three schizophrenia placebo-controlled, 6-week, fixed-dose studies in adults were 3% and 1% in INVEGA®-and placebo-treated subjects, respectively. The most common reasons for discontinuation were nervous system disorders (2% and 0% in INVEGA®-and placebo-treated subjects, respectively).

Among the adverse reactions in the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, only dystonia led to discontinuation (<1% of INVEGA®-treated subjects).

Schizoaffective Disorder Trials

The percentages of subjects who discontinued due to adverse reactions in the two schizoaffective disorder placebo-controlled 6-week studies in adults were 1% and <1% in INVEGA®-and placebo-treated subjects, respectively. The most common reasons for discontinuation were gastrointestinal disorders (1% and 0% in INVEGA®-and placebo-treated subjects, respectively).

Dose-Related Adverse Reactions

Based on the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia, among the adverse reactions that occurred with a greater than 2% incidence in the subjects treated with INVEGA®, the incidences of the following adverse reactions increased with dose: somnolence, orthostatic hypotension, akathisia, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, and salivary hypersecretion. For most of these, the increased incidence was seen primarily at the 12 mg dose, and, in some cases, the 9 mg dose.

In the 6-week, fixed-dose, placebo-controlled study in adolescents with schizophrenia, among the adverse reactions that occurred with >2% incidence in the subjects treated with INVEGA® , the incidences of the following adverse reactions increased with dose: tachycardia, akathisia, extrapyramidal symptoms, somnolence, and headache.

In a placebo-controlled, 6-week, high-and low-dose study in adult subjects with schizoaffective disorder, akathisia, dystonia, dysarthria, myalgia, nasopharyngitis, rhinitis, cough, and pharyngolaryngeal pain occurred more frequently (i.e., a difference of at least 2%) in subjects who received higher doses of INVEGA® compared with subjects who received lower doses.

Demographic Differences

An examination of population subgroups in the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and in the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder did not reveal any evidence of clinically relevant differences in safety on the basis of gender or race alone; there was also no difference on the basis of age .

Extrapyramidal Symptoms (EPS)

Pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia provided information regarding treatment-emergent EPS. Several methods were used to measure EPS: (1) the Simpson-Angus global score (mean change from baseline) which broadly evaluates Parkinsonism, (2) the Barnes Akathisia Rating Scale global clinical rating score (mean change from baseline) which evaluates akathisia, (3) use of anticholinergic medications to treat emergent EPS (Table 7), and (4) incidence of spontaneous reports of EPS (Table 8). For the Simpson-Angus Scale, spontaneous EPS reports and use of anticholinergic medications, there was a dose-related increase observed for the 9 mg and 12 mg doses. There was no difference observed between placebo and INVEGA® 3 mg and 6 mg doses for any of these EPS measures.

Table 7: Treatment-Emergent Extrapyramidal Symptoms (EPS) Assessed by Incidence of Ratings Scales and Use of Anticholinergic Medication – Schizophrenia Studies in Adults

EPS Group Placebo
(N=355)
Percentage of Patients
3 mg once daily
(N=127)
INVEGA® 12 mg once daily
(N=242)
6 mg once daily
(N=235)
9 mg once daily
(N=246)
Parkinsonisma 9 11 3 15 14
Akathisiab 6 6 4 7 9
Use of anticholinergic medicationsc 10 10 9 22 22
a For Parkinsonism, percent of patients with Simpson-Angus global score > 0.3 (Global score defined as total sum of items score divided by the number of items)
b For Akathisia, percent of patients with Barnes Akathisia Rating Scale global score ≥ 2
c Percent of patients who received anticholinergic medications to treat emergent EPS

Table 8: Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizophrenia Studies in Adults

EPS Group Placebo
(N=355)
Percentage of Patients
3 mg once daily
(N=127)
INVEGA® 12 mg once daily
(N=242)
6 mg once daily
(N=235)
9 mg once daily
(N=246)
Overall percentage of patients with EPS-related AE 11 13 10 25 26
Dyskinesia 3 5 3 8 9
Dystonia 1 1 1 5 5
Hyperkinesia 4 4 3 8 10
Parkinsonism 2 3 3 7 6
Tremor 3 3 3 4 3
Dyskinesia group includes: Dyskinesia, extrapyramidal disorder, muscle twitching, tardive dyskinesia
Dystonia group includes: Dystonia, muscle spasms, oculogyration, trismus
Hyperkinesia group includes: Akathisia, hyperkinesia
Parkinsonism group includes: Bradykinesia, cogwheel rigidity, drooling, hypertonia, hypokinesia, muscle rigidity, musculoskeletal stiffness, parkinsonism
Tremor group includes: Tremor

Compared to data from the studies in adults subjects with schizophrenia, pooled data from the two placebo-controlled 6-week studies in adult subjects with schizoaffective disorder showed similar types and frequencies of EPS as measured by rating scales, anticholinergic medication use, and spontaneous reports of EPS-related adverse events. For subjects with schizoaffective disorder, there was no dose-related increase in EPS observed for parkinsonism with the Simpson-Angus scale or akathisia with the Barnes Akathisia Rating Scale. There was a dose-related increase observed with spontaneous EPS reports of hyperkinesia and dystonia and in the use of anticholinergic medications.

Table 9 shows the EPS data from the pooled schizoaffective disorder trials.

Table 9: Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizoaffective Disorder Studies in  Adults

EPS Group Placebo
(N=202)
Percentage of Patients
INVEGA®
3-6 mg once-daily fixed-dose range
(N=108)
9-12 mg once-daily fixed-dose range
(N=98)
3-12 mg once-daily flexible dose
(N=214)
Overall percentage of patients with EPS-related AE 11 23 22 17
Dyskinesia 1 3 1 1
Dystonia 1 2 3 2
Hyperkinesia 5 5 8 7
Parkinsonism 3 14 7 7
Tremor 3 12 11 5
Dyskinesia group includes: Dyskinesia, muscle twitching
Dystonia group includes: Dystonia, muscle spasms, oculogyration
Hyperkinesia group includes: Akathisia, hyperkinesia, restlessness
Parkinsonism group includes: Bradykinesia, drooling, hypertonia, muscle rigidity, muscle tightness, musculoskeletal stiffness, parkinsonian gait, parkinsonism
Tremor group includes: Tremor

The incidences of EPS-related adverse events in the adolescent schizophrenia studies showed a similar dose-related pattern to those in the adult studies. There were notably higher incidences of dystonia, hyperkinesia, tremor, and parkinsonism in the adolescent population as compared to the adult studies (Table 10).

Table 10: Treatment-Emergent Extrapyramidal Symptoms (EPS)-Related Adverse Events by MedDRA Preferred Term – Schizophrenia Studies in Adolescent Subjects

EPS Group Placebo
(N=51)
Percentage of Patients
1.5 mg once daily
(N=54)
INVEGA® 12 mg once daily
(N=35)
3 mg once daily
(N=16)
6 mg once daily
(N=45)
Overall percentage of patients with EPS-related AE 0 6 25 22 40
Hyperkinesia 0 4 6 11 17
Dystonia 0 2 0 11 14
Tremor 0 2 6 7 11
Parkinsonism 0 0 6 2 14
Dyskinesia 0 2 6 2 6
Hyperkinesia group includes: Akathisia
Dystonia group includes: Dystonia, muscle contracture, oculogyric crisis, tongue paralysis, torticollis
Tremor group includes: Tremor
Parkinsonism group includes: Cogwheel rigidity, extrapyramidal disorder, muscle rigidity
Dyskinesia group includes: Dyskinesia, muscle contractions involuntary

Dystonia

Class Effect

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Laboratory Test Abnormalities

In the pooled data from the three placebo-controlled, 6-week, fixed-dose studies in adult subjects with schizophrenia and from the two placebo-controlled, 6-week studies in adult subjects with schizoaffective disorder, between-group comparisons revealed no medically important differences between INVEGA® and placebo in the proportions of subjects experiencing potentially clinically significant changes in routine serum chemistry, hematology, or urinalysis parameters. Similarly, there were no differences between INVEGA® and placebo in the incidence of discontinuations due to changes in hematology, urinalysis, or serum chemistry, including mean changes from baseline in fasting glucose, insulin, c-peptide, triglyceride, HDL, LDL, and total cholesterol measurements. However, INVEGA® was associated with increases in serum prolactin .

Other Adverse Reactions Observed During Premarketing Evaluation Of INVEGA®

The following additional adverse reactions occurred in < 2% of INVEGA®-treated subjects in the above schizophrenia and schizoaffective disorder clinical trial datasets. The following also includes additional adverse reactions reported at any frequency by INVEGA®-treated subjects who participated in other clinical studies.

Cardiac disorders: bradycardia, palpitations

Eye disorders: eye movement disorder

Gastrointestinal disorders: flatulence

General disorders: edema

Immune system disorders: anaphylactic reaction

Infections and infestations: urinary tract infection

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased

Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity

Nervous system disorders: opisthotonus

Psychiatric disorders: agitation, insomnia, nightmare

Reproductive system and breast disorders: breast discomfort, menstruation irregular, retrograde ejaculation

Respiratory, thoracic and mediastinal disorders: nasal congestion

Skin and subcutaneous tissue disorders: pruritus, rash

Vascular disorders: hypertension

The safety of INVEGA® was also evaluated in a long-term trial designed to assess the maintenance of effect with INVEGA® in adults with schizophrenia . In general, adverse reaction types, frequencies, and severities during the initial 14-week open-label phase of this study were comparable to those observed in the 6-week, placebo-controlled, fixed-dose studies. Adverse reactions reported during the long-term double-blind phase of this study were similar in type and severity to those observed in the initial 14-week open-label phase.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of INVEGA®; because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency: angioedema, ileus, priapism, swollen tongue, tardive dyskinesia, urinary incontinence, urinary retention.

Adverse Reactions Reported With Risperidone

Paliperidone is the major active metabolite of risperidone. Adverse reactions reported with risperidone can be found in the ADVERSE REACTIONS section of the risperidone package insert.

Read the entire FDA prescribing information for Invega (Paliperidone)

Paliperidone Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 6, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

In Summary

Commonly reported side effects of paliperidone include: akathisia, tachycardia, and drowsiness. Other side effects include: basal ganglia disease, dyskinesia, dystonia, orthostatic hypotension, postencephalitic parkinson’s disease, sialorrhea, and prolonged qt interval on ecg. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to paliperidone: oral tablet extended release

Other dosage forms:

  • intramuscular suspension extended release

Warning

Oral route (Tablet, Extended Release)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Paliperidone is not approved for the treatment of patients with dementia-related psychosis.

Along with its needed effects, paliperidone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking paliperidone:

More common

  • Difficulty with speaking
  • drooling
  • fast, pounding, or irregular heartbeat or pulse
  • increase in body movements
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back

Less common

  • Chest pain
  • cold sweats
  • confusion
  • cough
  • difficulty with swallowing
  • dizziness
  • excessive muscle tone
  • fainting
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • increased blood pressure
  • mask-like face
  • muscle tension or tightness
  • pain in the arms or legs
  • slow heartbeat
  • slowed movements
  • slurred speech
  • sticking out of the tongue when not meaning to
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • trembling and shaking of the fingers and hands
  • tremors
  • trouble with breathing, speaking, or swallowing
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions
  • unusual tiredness or weakness

Incidence not known

  • Decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • lip smacking or puckering
  • painful or prolonged erection of the penis
  • painful urination
  • puffing of cheeks
  • rapid or worm-like movements of the tongue
  • severe constipation
  • severe vomiting
  • stomach pain
  • uncontrolled chewing movements

Some side effects of paliperidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Absent, missed, or irregular menstrual periods
  • difficulty having a bowel movement
  • fear or nervousness
  • headache
  • inability to sit still
  • nausea
  • need to keep moving
  • sleepiness or unusual drowsiness
  • stopping of menstrual bleeding
  • vomiting
  • weight gain

Less common

  • Back pain
  • belching
  • blurred vision
  • changes in appetite
  • dry mouth
  • fever
  • heartburn
  • indigestion
  • lack or loss of strength
  • muscle aches
  • sore throat
  • stomach discomfort or upset
  • stuffy or runny nose
  • swelling or soreness of the breasts in both females and males
  • swollen tongue
  • unexpected or excess milk flow from breasts
  • upper stomach pain

Incidence not known

  • Sleepwalking

For Healthcare Professionals

Applies to paliperidone: intramuscular suspension extended release, oral tablet extended release

General

EXTENDED RELEASE TABLETS: The most commonly reported side effects included sedation, extrapyramidal disorder, akathisia, and hyperkinesia.

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included akathisia, parkinsonism, insomnia, and headache.

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included increased weight, insomnia, and use of anticholinergic medications (for extrapyramidal symptoms).

Nervous system

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Abnormal gait, dizziness, drooling, dysarthria, dyskinesia, hypertonia, lethargy

Rare (0.01% to 0.1%): Abnormal coordination, balance disorder, cerebral ischemia, depressed level of consciousness, diabetic coma, head titubation, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, bradykinesia, cerebrovascular accident/disorder, cervical spasm, chorea, choreoathetosis, cogwheel rigidity, emprosthotonus, facial spasm, grand mal convulsion, hypersomnia, hypokinesia, masked facies, movement disorder, myoclonus, myotonia, opisthotonos, parkinsonian gait, parkinsonian rest tremor, pleurothotonus, restless legs syndrome, risus sardonicus, tongue paralysis, vertigo

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Akathisia (up to 18%), parkinsonism (up to 18%), headache (up to 15%), extrapyramidal disorder (up to 12%)

Common (1% to 10%): Dizziness, dyskinesia, dystonia, hyperkinesia, sedation/somnolence, tremor

Rare (0.01% to 0.1%): Abnormal coordination, balance disorder, cerebral ischemia, cerebrovascular accident/disorder, depressed level of consciousness, diabetic coma, head titubation, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, choreoathetosis, cogwheel rigidity, emprosthotonus, facial spasm, grand mal convulsion, hypertonia, hypokinesia, masked facies, myoclonus, myotonia, opisthotonos, oropharyngeal spasm, parkinsonian gait, parkinsonian rest tremor, pleurothotonus, restless legs syndrome, risus sardonicus, tongue paralysis, tongue spasm, transient ischemic attack

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Rare (0.01% to 0.1%): Balance disorder, cerebral ischemia, convulsion, depressed level of consciousness, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal coordination, abnormal glabellar reflex, akinesia, athetosis, bradykinesia, cerebrovascular accident, chorea, choreoathetosis, cogwheel rigidity, diabetic coma, drooling, emprosthotonus, facial spasm, grand mal convulsion, head titubation, hypertonia, hypokinesia, involuntary muscle contractions, lethargy, masked facies, movement disorder, myoclonus, myotonia, on and off phenomenon, opisthotonos, oromandibular dystonia, oropharyngeal spasm, parkinsonian crisis, parkinsonian gait, parkinsonian rest tremor, Parkinson’s disease, pleurothotonus, restless leg syndrome, risus sardonicus, tongue paralysis, tongue spasm, transient ischemic attack

Extrapyramidal symptoms included oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, involuntary muscle contractions, parkinsonism gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia.

Based on pooled data from 6-week fixed dose studies, the following nervous system adverse events appear to be dose-related: akathisia, dystonia, extrapyramidal disorder, hypertonia, and parkinsonism. The increased incidence occurred primarily at the 12 mg dose, although in some cases, also the 9 mg dose.

Metabolic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Decreased appetite, decreased weight, increased appetite, increased weight

Uncommon (0.1% to 1%): Anorexia, diabetes mellitus, hyperglycemia, increased blood triglycerides, increased waist circumference, thirst

Rare (0.01% to 0.1%): Diabetic ketoacidosis, hypoglycemia, increased blood cholesterol, polydipsia, water intoxication

Frequency not reported: Hyperinsulinemia, increased c-peptide, increased fasting glucose, increased HDL, increased LDL, tetany

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Decreased appetite, decreased weight, hyperglycemia, increased blood cholesterol/low density lipoproteins/triglycerides, increased blood glucose, increased weight

Uncommon (0.1% to 1%): Anorexia, diabetes mellitus, hyperinsulinemia, increased appetite, thirst

Rare (0.01% to 0.1%): Diabetic ketoacidosis, hypoglycemia, polydipsia

Frequency not reported: Tetany, water intoxication

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Increased weight (up to 21.3%)

Common (1% to 10%): Decreased weight, hyperglycemia, increased blood glucose

Uncommon (0.1% to 1%): Anorexia, decreased appetite, diabetes mellitus, hyperinsulinemia, increased appetite, increased blood cholesterol/triglycerides

Rare (0.01% to 0.1%)K Diabetic ketoacidosis, hypoglycemia, polydipsia, thirst

Frequency not reported: Increased waist circumference, tetany, water intoxication

Psychiatric

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Agitation, anxiety, depression, insomnia, mania, sleep disorder

Uncommon (0.1% to 1%): Anorgasmia, confusional state, decreased libido, nervousness, nightmare, psychomotor hyperactivity

Rare (0.01% to 0.1%): Blunted affect, drug withdrawal syndrome, neonatal drug withdrawal syndrome

Frequency not reported: Initial insomnia, middle insomnia, restlessness

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Insomnia (up to 15%), agitation (up to 10%)

Common (1% to 10%): Anxiety, auditory hallucinations, depression, nightmare, suicidal ideation

Rare (0.01% to 0.1%): Anorgasmia, blunted affect, drug withdrawal syndrome

Frequency not reported: Initial insomnia, middle insomnia, neonatal drug withdrawal syndrome, psychotic disorder, schizophrenia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Agitation, anxiety, depression, insomnia, schizophrenia

Rare (0.01% to 0.1%): Anorgasmia, confusional state, drug withdrawal syndrome, mania

Frequency not reported: Initial insomnia, middle insomnia, neonatal drug withdrawal syndrome, restlessness, suicidal ideation

Cardiovascular

In a QT study evaluating the effect of immediate-release oral paliperidone 8 mg (n=50), a mean placebo-subtracted increase from baseline on day 8 at 1.5 hours postdose was 12.3 milliseconds (ms). The mean steady-state peak plasma concentration achieved with immediate-release paliperidone was determined to be more than twice the exposure expected with the recommended 12 mg dose. None of the subjects had a QTc interval exceeding 60 ms. According to the phase 3 safety database which included double-blind and open-label extension studies (n=2054), 2 patients experienced QTc interval prolongation greater than 500 ms.

In placebo controlled trials with oral paliperidone, orthostatic hypotension increased with increasing doses, primarily at the 12 mg per day dose.

EXTENDED RELEASE TABLETS:

Very common (10% or more): Tachycardia (up to 14%)

Common (1% to 10%): Bradycardia, bundle branch block, first-degree atrioventricular block/atrioventricular block, conduction disorder, electrocardiogram QT prolonged, hypertension, orthostatic hypotension, sinus arrhythmia, sinus tachycardia

Uncommon (0.1% to 1%): Abnormal electrocardiogram, chest discomfort/pain, edema, hypotension, palpitations

Frequency not reported: Cardiac arrest, generalized edema, increased blood pressure, increased heart rate, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmia, ventricular tachycardia

Postmarketing reports: Deep vein thrombosis

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Bradycardia, electrocardiogram QT prolonged, hypertension, tachycardia/sinus tachycardia/increased heart rate

Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrioventricular block, chest discomfort/pain, conduction disorder, edema, hypotension, orthostatic hypotension, palpitations, postural orthostatic tachycardia syndrome

Rare (0.01% to 0.1%): Atrial fibrillation, flushing, sinus arrhythmia, venous thrombosis/thromboembolism

Frequency not reported: Bundle branch block, cardiac arrest, deep vein thrombosis, first-degree atrioventricular block/atrioventricular block, generalized edema, ischemia, left bundle branch block, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Bradycardia, hypertension, tachycardia/sinus tachycardia

Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrioventricular block, chest discomfort/pain, conduction disorder, edema, electrogram QT prolonged, hypotension, orthostatic hypotension, palpitations, postural orthostatic tachycardia syndrome

Rare (0.01% to 0.1%): Atrial fibrillation, flushing, sinus arrhythmia, venous thrombosis/thromboembolism

Frequency not reported: Bundle branch block, cardiac arrest, deep vein thrombosis, first-degree atrioventricular block, generalized edema, ischemia, left bundle branch block, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia

Other

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Asthenia, fatigue, pyrexia

Uncommon (0.1% to 1%): Chills, ear infection, ear pain, falls, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Decreased body temperature, hypothermia

Frequency not reported: Sudden unexplained death

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Asthenia, fatigue, pain, pyrexia

Uncommon (0.1% to 1%): Ear infection, ear pain, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Chills, decreased body temperature, hypothermia

Frequency not reported: Fall, sudden unexplained death

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Use of anticholinergic medications (up to 11%)

Common (1% to 10%): Asthenia, fatigue, pyrexia

Uncommon (0.1% to 1%): Ear infection, ear pain, fall, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Chills, hypothermia

Frequency not reported: Decreased body temperature, sudden unexplained death

Gastrointestinal

EXTENDED RELEASE TABLETS:

Very common (10% or more): Vomiting (up to 11%)

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastroenteritis, swollen tongue

Rare (0.01% to 0.1%): Cheilitis, fecal incontinence, fecaloma, ileus, intestinal obstruction, pancreatitis

Frequency not reported: Difficulty swallowing, tongue protrusion, tongue spasm, upper abdominal pain/discomfort/stomach discomfort

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastroenteritis, salivary hypersecretion

Rare (0.01% to 0.1%): Cheilitis, fecaloma, fecal incontinence, pancreatitis, swollen tongue

Frequency not reported: Ileus, intestinal obstruction, small intestinal obstruction

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, nausea, toothache, vomiting

Uncommon (0.1% to 1%): Abdominal discomfort, dry mouth, dysphagia, flatulence, gastroenteritis

Rare (0.01% to 0.1%): Cheilitis, difficulty swallowing, fecaloma, fecal incontinence, pancreatitis, swollen tongue

Frequency not reported: Ileus, intestinal obstruction, salivary hypersecretion, small intestinal obstruction, tongue protrusion, upper abdominal pain

Local

Redness and swelling were observed in 2% or less of patients receiving the 3-month IM extended-release suspension. Residual injection pain peaked 1 or 6 hours after injection and trended downward 3 days after the injection. Deltoid injections were numerically more painful than gluteal injections.

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Injection site reactions (up to 10%)

Common (1% to 10%):

Rare (0.01% to 0.1%): Injection site abscess, injection site cellulitis, injection site cyst, injection site hematoma/bruising

Frequency not reported: Injection site extravasation, injection site induration, injection site irritation/pruritus/erythema/discomfort, injection site joint pain, injection site mass, injection site necrosis, injection site nodule, injection site pain, injection site swelling/edema/inflammation, injection site ulcer

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Injection site induration, injection site pain, injection site reaction

Rare (0.01% to 0.1%): Injection site abscess, injection site cellulitis, injection site cyst, injection site hematoma

Frequency not reported: Injection site erythema, injection site extravasation, injection site inflammation, injection site necrosis, injection site nodule/mass, injection site ulcer

Musculoskeletal

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Arthralgia, back pain, extremity pain, musculoskeletal pain, musculoskeletal stiffness, myalgia

Rare (0.01% to 0.1%): Abnormal posture, rhabdomyolysis

Frequency not reported: Involuntary muscle contractions, muscle contracture, muscle rigidity/tightness/twitching, neck muscle spasm, nuchal rigidity, torticollis, trismus

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain

Uncommon (0.1% to 1%): Increased blood creatine phosphokinase, joint stiffness, muscle rigidity/tightness, muscle spasms/twitching, muscular weakness, neck pain

Rare (0.01% to 0.1%): Abnormal posture, joint swelling, nuchal rigidity, rhabdomyolysis

Frequency not reported: Involuntary muscle contractions, muscle contracture, musculoskeletal stiffness, neck muscle spasm, torticollis, trismus

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain

Rare (0.01% to 0.1%): Joint swelling

Frequency not reported: Abnormal posture, cervical spasm, extremity pain, muscle contracture, muscle rigidity, muscle tightness, musculoskeletal stiffness, myalgia, neck muscle spasm, nuchal rigidity, rhabdomyolysis, torticollis, trismus

Respiratory

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Bronchitis, cough, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, rhinitis, sinusitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Dyspnea, pneumonia, respiratory tract infection, tonsillitis, wheezing

Frequency not reported: Difficulty breathing, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary congestion, rales, throat tightness

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Cough, dyspnea, nasal congestion, nasopharyngitis, oropharyngeal pain, upper respiratory tract infection

Uncommon (0.1% to 1%): Bronchitis, epistaxis, pharyngolaryngeal pain, pneumonia, respiratory tract congestion, respiratory tract infection, sinusitis, tonsillitis, wheezing

Rare (0.01% to 0.1%): Pulmonary congestion syndrome, rales, sleep apnea syndrome

Frequency not reported: Aspiration pneumonia, difficulty breathing, dysphonia, hyperventilation, laryngospasm, pulmonary embolism, rhinitis, rhinorrhea, throat tightness, tongue protrusion

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Cough, nasal congestion, nasopharyngitis, upper respiratory tract infection

Rare (0.01% to 0.1%): Pulmonary congestion, respiratory tract congestion, sleep apnea syndrome, wheezing

Frequency not reported: Aspiration pneumonia, difficulty breathing, dysphonia, hyperventilation, laryngospasm, pharyngitis, pulmonary embolism, rales, rhinitis, throat tightness

Genitourinary

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Amenorrhea, galactorrhea, urinary tract infection

Uncommon (0.1% to 1%): Breast discomfort/pain/tenderness, dysuria, ejaculation disorder, erectile dysfunction, menstrual disorder, pollakiuria, sexual dysfunction, urinary incontinence, urinary retention

Rare (0.01% to 0.1%): Breast discharge/engorgement/enlargement, delayed menstruation, priapism, vaginal discharge

Frequency not reported: Breast swelling, irregular menstruation, menstrual disturbances, oligomenorrhea, retrograde ejaculation

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Amenorrhea, galactorrhea, urinary tract infection

Uncommon (0.1% to 1%): Breast pain, delayed menstruation, dysuria, ejaculation disorder, erectile dysfunction, irregular menstruation, menstrual disorder, pollakiuria, sexual dysfunction, urinary incontinence, vaginal discharge

Rare (0.01% to 0.1%): Breast discharge, breast discomfort/engorgement/enlargement, urinary retention

Frequency not reported: Oligomenorrhea, priapism, retrograde ejaculation

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Amenorrhea, menstrual disorder, urinary tract infection

Uncommon (0.1% to 1%): Breast discomfort/pain, delayed menstruation, dysuria, ejaculation disorder, erectile dysfunction, galactorrhea, pollakiuria, sexual dysfunction, urinary incontinence

Rare (0.01% to 0.1%): Breast engorgement/enlargement, urinary retention, vaginal discharge

Frequency not reported: Breast discharge, delayed menstruation, irregular menstruation, oligomenorrhea, priapism, retrograde ejaculation

Galactorrhea, amenorrhea, and impotence have been reported in patients receiving prolactin-elevating compounds.

Dermatologic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Acne, alopecia, eczema, face edema, urticaria

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Skin laceration

Rare (0.01% to 0.1%): Dandruff, drug eruption, hyperkeratosis, seborrheic dermatitis, skin discoloration

Frequency not reported: Papular rash

Postmarketing reports: Hyperhidrosis, thrombotic thrombocytopenic purpura

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Rash

Rare (0.01% to 0.1%): Dandruff, drug eruption, hyperkeratosis, subcutaneous abscess

Frequency not reported: Generalized pruritus, induration, papular rash, seborrheic dermatitis, skin discoloration

Postmarketing reports: Thrombotic thrombocytopenic purpura

Hepatic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Increased transaminases (ALT, AST)

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Rare (0.01% to 0.1%): Jaundice

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Increased transaminases (AST, ALT)

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Frequency not reported: Jaundice

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Increased transaminases

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Frequency not reported: Jaundice

Immunologic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Influenza

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Influenza

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Influenza

Ocular

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Blurred vision, oculogyric crisis

Uncommon (0.1% to 1%): Conjunctivitis, dry eye, photophobia

Rare (0.01% to 0.1%): Eye infection, eye movement disorder, eye rolling, glaucoma, increased lacrimation, ocular hyperemia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Eye swelling

Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, dry eye, eye infection

Rare (0.01% to 0.1%): Eye movement disorder, eye rolling, glaucoma, increased lacrimation, ocular hyperemia, photophobia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration, oculogyric crisis

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, dry eye, increased lacrimation

Rare (0.01% to 0.1%): Eye infection, eye movement disorder, eye rolling, glaucoma, ocular hyperemia, photophobia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration, oculogyric crisis

Endocrine

Paliperidone has a prolactin-elevating effect similar to that seen with risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs.

Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH), resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Gynecomastia has been reported in patients receiving prolactin-elevating compounds.

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Hyperprolactinemia

Rare (0.01% to 0.1%): Gynecomastia, inappropriate antidiuretic hormone secretion

Frequency not reported: Increased serum prolactin

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Hyperprolactinemia

Uncommon (0.1% to 1%): Gynecomastia

Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Gynecomastia, hyperprolactinemia

Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion

Hematologic

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Anemia, decreased hematocrit, decreased white blood cell count, thrombocytopenia

Rare (0.01% to 0.1%): Agranulocytosis, increased eosinophil count, neutropenia

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Anemia, decreased hematocrit, decreased white blood cell count, increased eosinophil count, thrombocytopenia

Rare (0.01% to 0.1%): Neutropenia

Frequency not reported: Agranulocytosis

Postmarketing reports: Granulocytopenia, leukopenia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Anemia, decreased white blood cell count, neutropenia, thrombocytopenia

Rare (0.01% to 0.1%): Increased eosinophil count

Frequency not reported: Agranulocytosis

Hypersensitivity

There have been postmarketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone or oral paliperidone.

EXTENDED RELEASE TABLETS:

Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema, hypersensitivity

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction, angioedema

Postmarketing reports: Anaphylactic shock, anaphylaxis

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction, angioedema

Renal

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Cystitis

Rare (0.01% to 0.1%): Presence of glucose in urine

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Cystitis

Rare (0.01% to 0.1%): Presence of glucose in urine

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Cystitis, presence of glucose in urine

1. “Product Information. Invega (paliperidone).” Janssen Pharmaceuticals, Titusville, NJ.

2. “Product Information. Invega Sustenna (paliperidone).” Janssen Pharmaceuticals, Titusville, NJ.

3. Cerner Multum, Inc. “Australian Product Information.” O 0

4. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

5. “Product Information. Invega Trinza (paliperidone).” Janssen Pharmaceuticals, Titusville, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about paliperidone

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Pricing & Coupons
  • 297 Reviews
  • Drug class: atypical antipsychotics
  • FDA Alerts (3)

Consumer resources

  • Paliperidone
  • Paliperidone injection
  • Paliperidone Extended-Release Tablets
  • Paliperidone (Advanced Reading)
  • Paliperidone Intramuscular (Advanced Reading)

Other brands: Invega, Invega Sustenna, Invega Trinza

Professional resources

  • Paliperidone (AHFS Monograph)
  • … +2 more

Related treatment guides

  • Schizoaffective Disorder
  • Autism
  • Bipolar Disorder
  • Borderline Personality Disorder
  • Depression
  • Schizophrenia

Frequently Asked Questions

INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious sides effects including:

  • stroke in elderly people (cerebrovascular problems) that can lead to death
  • Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA TRINZA® OR INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure
  • problems with your heartbeat. These heart problems can cause death. Call your healthcare provider right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats
  • uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain
  • low blood pressure and fainting
  • changes in your blood cell counts
  • high level of prolactin in your blood (hyperprolactinemia). INVEGA TRINZA® and INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection
  • problems thinking clearly and moving your body
  • seizures
  • difficulty swallowing that can cause food or liquid to get into your lungs
  • prolonged or painful erection lasting more than 4 hours. Call your healthcare provider or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours
  • problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.

Invega is the brand name of the prescription drug paliperidone, used to treat symptoms of schizophrenia.

The medicine may also be prescribed for some types of depression and other mental health conditions.

Invega belongs to a class of drugs called antipsychotics. It works by altering the activity of certain natural substances in the brain.

The U.S. Food and Drug Administration (FDA) approved Invega in 2006. It’s marketed by Janssen Pharmaceuticals, Inc.

Invega Warnings

Invega contains a black box warning because it shouldn’t be taken by older adults with dementia.

Studies have shown that antipsychotics like Invega can raise the risk of heart failure, stroke, mini-stroke, or death in these people.

Before taking Invega, tell your doctor if you have, or have ever had:

  • Prolonged QT interval (a heart condition that can cause fainting or irregular heartbeat)
  • A slow or irregular heartbeat
  • High or low blood pressure
  • High cholesterol or triglycerides
  • A low white blood cell count
  • A heart attack or stroke
  • Seizures
  • A head injury
  • A brain tumor
  • Parkinson’s disease
  • Low levels of magnesium or potassium in the blood
  • Diabetes
  • Breast cancer
  • Surgery on your intestines
  • Cystic fibrosis, inflammatory bowel disease (IBD), or any condition that causes blockage or narrowing of the esophagus, stomach, or intestines
  • Heart, kidney, or liver disease
  • Suicidal thoughts
  • Allergies to medicines

Also, let your healthcare provider know if you’ve ever consumed large amounts of alcohol, used illegal or recreational drugs, or abused prescription medications.

Let your doctor know you’re taking this medicine before having any type of surgery, including a dental procedure.

Invega may raise your blood glucose levels, even if you don’t have diabetes. Tell your doctor right away if you experience:

  • Extreme thirst or hunger
  • Frequent urination
  • Weakness
  • Blurred vision
  • Dry mouth
  • Nausea or vomiting
  • Shortness of breath
  • Breath that smells fruity
  • Loss of consciousness

In rare cases, Invega can cause a serious movement disorder that may not be reversible. Talk to your doctor about this risk.

The medicine may also make it more difficult for your body to cool down when it gets hot. Tell your doctor if you plan to exercise or stay outdoors in the heat while taking Invega.

Drink plenty of fluids if you’re exposed to hot weather.

Older adults may be more sensitive to the side effects of Invega and should use this medicine with caution.

Invega helps control symptoms of schizophrenia, but it won’t cure the condition.

Continue taking this medicine even if you feel well. Don’t stop taking Invega without first talking to your doctor.

Pregnancy and Invega

It’s not known whether Invega can harm a fetus.

Tell your doctor if you’re pregnant, or might become pregnant, before taking this medicine.

If you become pregnant while taking the drug, don’t stop taking it without first talking with your doctor.

Taking an antipsychotic medicine during the last three months of pregnancy can cause withdrawal symptoms in newborns. Talk to your healthcare provider about this risk.

Invega passes into breast milk and may harm a breastfeeding baby. Don’t breastfeed while taking this medicine.

Invega Sustenna Syringe

Precautions

See also Warnings section.

Before using paliperidone, tell your doctor or pharmacist if you are allergic to it; or to risperidone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, low white blood cell count (leukopenia), seizures, Parkinson’s disease, dementia, certain eye problems (cataracts, glaucoma), personal or family history of diabetes, high cholesterol/triglyceride levels, heart disease (such as previous heart attack), breathing trouble during sleep (sleep apnea).

Paliperidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using paliperidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using paliperidone safely.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Before having surgery (including cataract/glaucoma eye surgery), tell your doctor or dentist if you are using or have ever used this medication, and about all the other products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, schizoaffective disorders) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops symptoms such as muscle stiffness or shakiness, unusual sleepiness, or difficulty feeding. Consult your doctor before breast-feeding.

INDICATIONS

Important Safety Information

INVEGA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). INVEGA® is not for treating dementia-related psychosis.

Do not receive INVEGA® if you are allergic to paliperidone, risperidone, or any of the ingredients in INVEGA®.

Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive INVEGA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with INVEGA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.

One risk of INVEGA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your healthcare professional about any current or past heart problems. Because these problems could mean you’re having a heart rhythm abnormality, contact your healthcare professional IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

  • High blood sugar and diabetes have been reported with INVEGA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your healthcare professional if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.
  • Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your healthcare professional while on treatment.
  • Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment. For adolescent patients (12-17 years of age) weight gain should be assessed against that expected with normal growth.

INVEGA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects, including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

People with narrowing or blockage of the gastrointestinal tract (esophagus, stomach, or small or large intestine) should talk to their healthcare professional before taking INVEGA®.

Some people taking INVEGA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect may be reduced.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare provider for the potential risk of falls.

Blood problems such as low numbers of white blood cells have been reported in patients taking INVEGA® and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your healthcare professional may choose to test your blood as you start therapy with INVEGA®.

INVEGA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA® affects you.

INVEGA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

INVEGA® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

INVEGA® should be swallowed whole. Tablets should not be chewed, divided, or crushed. Do not be worried if you see something that looks like a tablet in your stool. This is what is left of the tablet after all the medicine has been released.

Some medications interact with INVEGA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking INVEGA®.

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if INVEGA® will harm your unborn baby. If you become pregnant while taking INVEGA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961- 2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry Infants born to women who are treated with INVEGA ® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. INVEGA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA®.

INVEGA® may impair fertility, which is reversible. Speak to your healthcare professional if you plan to become pregnant.

The most common side effects that occurred with INVEGA® in the treatment of schizophrenia in adults were: abnormal muscle movements (including tremor ), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes); feeling of inner restlessness or needing to be constantly moving; and fast heartbeat.

The most common side effects that occurred with INVEGA® in the treatment of schizoaffective disorder in adults were: abnormal muscle movements (including tremor ), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes), sleepiness, heartburn, constipation, weight increase, and sore throat.

This is not a complete list of all possible side effects. Ask your healthcare professional or treatment team if you have any questions or want more information.

If you have any questions about INVEGA® or your therapy, talk with your healthcare professional

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA® and discuss any questions you have with your healthcare professional.

cp-64199v2

What is Invega Sustenna?

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may raise your risk of having a stroke. This is more likely in people who already have heart or blood vessel disease. Check with your doctor right away if you are having confusion, difficulty in speaking, slow speech, inability to speak or move the arms, legs, or facial muscles, double vision, or headache.

Check with your doctor right away if you have any of the following symptoms while receiving this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while receiving this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine can cause changes in heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may increase the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Paliperidone injection can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause difficulty swallowing that can cause food or liquid to get into your lungs and a prolonged or painful erection, which can last for more than 4 hours. Talk to your doctor if you have any concerns about this.

This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are receiving risperidone injection. If you become too cold, you may feel drowsy, confused, or clumsy.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are receiving this medicine. Talk to your doctor about ways to prevent weight gain.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter ) medicines and herbal or vitamin supplements.

paliperidone (injection) (Invega Sustenna, Invega Trinza)

Brand Names: Invega Sustenna, Invega Trinza

Generic Name: paliperidone (injection)

  • What is paliperidone (Invega Sustenna, Invega Trinza)?
  • What are the possible side effects of paliperidone (Invega Sustenna, Invega Trinza)?
  • What is the most important information I should know about paliperidone (Invega Sustenna, Invega Trinza)?
  • What should I discuss with my healthcare provider before using paliperidone (Invega Sustenna, Invega Trinza)?
  • How is paliperidone given (Invega Sustenna, Invega Trinza)?
  • What happens if I miss a dose (Invega Sustenna, Invega Trinza)?
  • What happens if I overdose (Invega Sustenna, Invega Trinza)?
  • What should I avoid while using paliperidone (Invega Sustenna, Invega Trinza)?
  • What other drugs will affect paliperidone (Invega Sustenna, Invega Trinza)?
  • Where can I get more information (Invega Sustenna, Invega Trinza)?

What is paliperidone (Invega Sustenna, Invega Trinza)?

Paliperidone is an antipsychotic medicine that is used to treat schizophrenia in adults. Paliperidone is also used alone or with other medicines to treat schizoaffective disorder in adults.

Paliperidone may also be used for purposes not listed in this medication guide.

What are the possible side effects of paliperidone (Invega Sustenna, Invega Trinza)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have any of these signs of a serious movement disorder:

  • tremors or shaking in your arms or legs;
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or
  • any new or unusual muscle movements you cannot control.

Call your doctor at once if you have:

  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • trouble swallowing;
  • a seizure (convulsions);
  • breast swelling (in women or men), nipple discharge;
  • changes in menstrual periods;
  • impotence, or penis erection that is painful or lasts 4 hours or longer;
  • weight gain;
  • fever, chills, sore throat, mouth sores, feeling light-headed;
  • high blood sugar–increased thirst, increased urination, hunger, fruity breath odor; or
  • severe nervous system reaction–very stiff (rigid) muscles, high fever, fast or pounding heartbeats, fainting.

Common side effects may include:

  • dizziness, drowsiness;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • feeling restless or anxious;
  • muscle stiffness, tremors or shaking;
  • uncontrolled muscle movements, trouble with walking, balance, or speech;
  • abnormal movements of your eyes;
  • weight gain;
  • upset stomach, constipation;
  • fast heart rate; or
  • pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about paliperidone (Invega Sustenna, Invega Trinza)?

Paliperidone is not approved for use in older adults with dementia-related conditions.

INVEGA SUSTENNA® (paliperidone palmitate)Important Safety Information and Side Effects

INDICATIONS

INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) Extended-Release Injectable Suspension is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used for schizoaffective disorder in adults, either alone or in combination with other medicines such as mood stabilizers or antidepressants, and is used to treat schizophrenia in adults.

What is the most important information I should know about INVEGA SUSTENNA® ?
INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA SUSTENNA® is not for treating dementia-related psychosis.

Do not receive INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA SUSTENNA® ingredients.

Before you receive INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:

  • have had Neuroleptic Malignant Syndrome (NMS)
  • have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome
  • have or have had low levels of potassium or magnesium in your blood
  • have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • have or have had kidney or liver problems
  • have diabetes or have a family history of diabetes
  • have had a low white blood cell count
  • have had problems with dizziness or fainting or are being treated for high blood pressure
  • have or have had seizures or epilepsy
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if INVEGA SUSTENNA® will harm your unborn baby
    • If you become pregnant while taking INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1‑866‑961‑2388 or visit http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/.
    • Infants born to women who are treated with INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur.
  • are breastfeeding or plan to breastfeed. INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA SUSTENNA®.

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.

What should I avoid while receiving INVEGA SUSTENNA®?

  • INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA SUSTENNA® affects you
  • avoid getting overheated or dehydrated

INVEGA SUSTENNA® may cause serious side effects, including:

  • See “What is the most important information I should know about INVEGA SUSTENNA®?”
  • stroke in elderly people (cerebrovascular problems) that can lead to death
  • Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure
  • problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out; dizziness; or feeling as if your heart is pounding or missing beats
  • uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia)
  • metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain
  • low blood pressure and fainting
  • changes in your blood cell counts
  • high level of prolactin in your blood (hyperprolactinemia). INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection
  • problems thinking clearly and moving your body
  • seizures
  • difficulty swallowing that can cause food or liquid to get into your lungs
  • prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours
  • problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration

The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

General information about the safe and effective use of INVEGA SUSTENNA®.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give INVEGA SUSTENNA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA SUSTENNA® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about INVEGA SUSTENNA®. If you would like more information, talk with your healthcare professional.
You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegasustenna.com or call 1‑800‑526‑7736.

Please click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional.

cp-64205v1

Generic Name: Paliperidone (pal-ee-PER-i-done)

Drug Class: Antipsychotics

Table of Contents

  • Overview
  • How to Take It
  • Side Effects
  • Warnings & Precautions
  • Drug Interactions
  • Dosage & Missing a Dose
  • Storage
  • Pregnancy or Nursing
  • More Information

Overview

Invega (paliperidone) is an antipsychotic medicine used to treat certain mood and mental disorders, including schizophrenia. It may decrease hallucinations and help promote clear and positive thinking. It may also help you to feel less agitated and take an active role in everyday life.

This medication is for use in adults and teenagers who are at least 12 years old.

This information is for educational purposes only. Not every known side effect, adverse effect, or drug interaction is in this database. If you have questions about your medicines, talk to your health care provider.

It works by helping change certain chemicals in the brain, which professionals refer to as “neurotransmitters.” It is not yet well-understood why changing these neurochemicals results in symptom relief for the conditions this drug is commonly prescribed for.

How to Take It

Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. Continue to take this medicine even if you feel well. Do not miss any doses.

Side Effects

Side effects that may occur while taking this medicine include:

  • nervousness
  • heartburn
  • tiredness
  • sour stomach
  • abdominal pain
  • drooling
  • swollen tongue
  • headache
  • weight gain
  • difficulty having a bowel movement

Contact your doctor immediately if you experience:

  • loss of balance control
  • difficulty swallowing
  • pain in the arms or legs
  • signs of infection
  • restlessness
  • fainting
  • twisting movements of the body
  • cold sweats
  • muscle spasms
  • tremors
  • dizziness
  • slowed movements

Warnings & Precautions

  • Invega may impair reactions and thinking. Use caution when driving or doing activities that require you to be alert.
  • This medication may cause heart failure in the elderly with dementia-related conditions.
  • You may develop neuroleptic malignant syndrome (NMS) while taking this medication. If you experience severe confusion, dark urine or change in urine output, fever, muscle stiffness, severe tiredness, sweating, or rapid heartbeat, call your doctor immediately.
  • Tell your doctor of any medical conditions you might have, including cataracts, cystic fibrosis, low white blood cell count, high cholesterol, and liver or kidney disease.
  • Your blood sugar may rise while taking Invega. Tell your doctor if you experience increased thirst and urination. Check your blood levels regularly if you have diabetes while taking this medication.
  • You may develop tardive dyskinesia while taking this medication (rare). Call your doctor immediately if you experience any unusual/uncontrolled movements of the lips, mouth, face, tongue, legs, or arms.
  • For an overdose, seek medical attention immediately. For non-emergencies, contact your local or regional poison control center at 1-800-222-1222.

Drug Interactions

Before taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. This includes supplements and herbal products.

Dosage & Missed Dose

Invega is available in extended-release tablet form. It is taken by mouth once, at the same time each day, with or without food.

If you skip a dose, take your next dose as soon as you remember. If it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not double doses or take extra medicine to make up for the missed dose.

Storage

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (preferably not in the bathroom). Throw away any medication that is outdated or no longer needed.

Pregnancy/Nursing

Taking this medicine during the last 3 months of pregnancy may cause problems in a newborn baby. However, you may have withdrawal symptoms or other problems if you stop taking Invega during pregnancy. If you become pregnant while taking this medicine, do not stop taking it before consulting your doctor.

DO NOT breast-feed while using this medicine.

More Information

For more information, talk to your doctor, pharmacist or health care provider, or you can visit this website, https://www.nlm.nih.gov/medlineplus/druginfo/meds/a607005.html for additional information from the manufacturer of this drug.

Invega

What is Invega?

Invega is a medication known as an atypical antipsychotic that is used to treat symptoms of schizophrenia.

When did the U.S. Food and Drug Administration (FDA) approve the medication?

Invega was first approved by the FDA in 2006.

Is there a generic version of Invega?

Yes, paliperidone is the generic version of Invega and is available in the United States.

Are there any major differences between Invega and other antipsychotics used to treat Invega?

Invega belongs to the class of medications known as atypical antipsychotics or second generation psychotics. Talk to your doctor about what might work best for you and the costs and benefits of taking the medication. Some people may need to try several different antipsychotics before they find the most effective with the fewest side effects.

Can children take Invega?

The efficacy of Invega for treating teenagers ages 12 to 17 has been established. However, teens taking atypical antipsychotics can be at higher risk for side effects such as weight gain. Talk to your child’s doctor about the risks of using the medication.

Are there potential interaction issues for people taking Invega and any other drugs?

There are hundreds of other drugs which are known to interact with Invega in major, moderate, or mild ways, so let your doctor know what other medications you are taking before you begin taking the medication. Some of these include antidepressants, antibiotics, antipsychotics, cisapride, levodopa, anxiety medications blood pressure medications, heart medications, procainamide, quinidine, sotalol, sedatives, sleep medications, and tranquilizers. Also let your doctor know if you have an allergic reaction to the Invega, Risperdal, or any other medications.

Are there any other medical conditions that would make someone ineligible for Invega therapy?

Talk to your doctor about other medical conditions before you take Invega, such as dementia,

heart issues, seizures, stroke, brain tumor, Parkinson’s disease, diabetes, breast cancer, stomach conditions, inflammatory bowel disease, kidney disease, or liver disease. Also, talk to your doctor if you have a history of substance abuse or any other mental health issues.

What is the typical starting dose that would be prescribed to someone taking Invega?

The recommended dosage for Invega Extended-Release tablets is 6mg taken once daily in the morning. Some patients may benefit from a higher or lower dosage, but a dosage above 12mg daily is not recommended.

What do I do if I miss a dose?

Take the dose of Invega when you remember, but skip the missed dose if it it’s almost time for your next dose. You should never take extra doses of the medication to make up for missed doses.

What common side effects can Invega cause?

Common side effects of Invega can include:

  • Dizziness
  • Dry mouth
  • Weight gain
  • Headaches
  • Extreme fatigue
  • Stomach pain
  • Weakness
  • Increased saliva

Doctors recommend that you not drink alcohol while on the medication. It also is recommended that you wait to drive or operate machinery until you know how the medication affects you. Report major side effects to your doctor immediately, which can include fever, sweating, confusion, irregular or fast heartbeat, muscle pain, restlessness, slow or stiff movements, uncontrollable movement of face or body, and painful erections that last for hours. You can also report side effects to the FDA at 1-800-FDA-1088 or online.

What are the potential long-term effects of taking Invega?

Your doctor should monitor for progression of potential long-term side effect of Invega, which can include weight gain, high blood sugar, high cholesterol, and tardive dyskinesia.

Is it safe for a woman who is pregnant, about to become pregnant, or nursing to take Invega?

There have been no controlled human pregnancy studies on the effects of Invega. The drug may be transferred via human breast milk and potentially harm a baby. Therefore, before taking Invega, talk to your doctor if you are pregnant, planning to become pregnant, or are nursing.

Can symptoms occur if Invega is discontinued?

It’s important not to stop taking the drug if you feel better. Maintain contact with your doctor and seek medical attention if necessary when discontinuing the drug. Talk to your doctor about how to mitigate potential withdrawal symptoms.

What should I do if I overdose on Invega?

Seek immediate help or call the Poison Help Line at 1-800-222-1222 if you overdose, as it can be fatal. Symptoms may include drowsiness, unsteadiness, restlessness, increased heartbeat, slow or stiff movement, and uncontrollable movement of face or body.

Is Invega habit-forming?
Invega has no habit-forming potential, but it is not recommended that you discontinue use of the drug before talking with your doctor, as withdrawal symptoms can occur.

How much does Invega cost?

According to goodrx.com, 30 tablets of 6mg Invega cost approximately $1,000. Thirty tablets of 6mg generic paliperidone cost approximately $800.

Are there any disadvantages to Invega?

The biggest disadvantages of Invega are the potential long-term side effects, which can include tardive dyskinesia, increased blood sugar, increased cholesterol, and weight gain.

DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider. This article mentions drugs that were FDA-approved and available at the time of publication and may not include all possible drug interactions or all FDA warnings or alerts. The author of this page explicitly does not endorse this drug or any specific treatment method. If you have health questions or concerns about interactions, please check with your physician or go to the FDA site for a comprehensive list of warnings.

Article Sources Last Updated: Nov 25, 2018

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *