Side effects of geodon

Contents

Geodon Side Effects

Generic Name: ziprasidone

Medically reviewed by Drugs.com. Last updated on Feb 13, 2019.

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

Note: This document contains side effect information about ziprasidone. Some of the dosage forms listed on this page may not apply to the brand name Geodon.

In Summary

Common side effects of Geodon include: drowsiness, weight gain, dizziness, headache, and nausea. Other side effects include: respiratory system disorder, extrapyramidal reaction, orthostatic hypotension, and pain at injection site. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ziprasidone: oral capsule

Other dosage forms:

  • intramuscular powder for solution

Warning

Oral route (Capsule; Suspension)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Ziprasidone hydrochloride is not approved for the treatment of elderly patients with dementia-related psychosis.

Along with its needed effects, ziprasidone (the active ingredient contained in Geodon) 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 ziprasidone:

More common

  • Cough
  • difficulty with speaking
  • drooling
  • fear or nervousness
  • fever
  • inability to sit still
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • need to keep moving
  • restlessness
  • shuffling walk
  • sneezing
  • sore throat
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back

Less common

  • Blurred vision
  • body aches or pain
  • chest pain
  • congestion
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • hoarseness
  • pounding in the ears
  • runny nose
  • slow or fast heartbeat
  • swelling of the tongue
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes

Rare

  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • persistent, painful erection
  • seizures

Incidence not known

  • Inability to move the eyes
  • increased blinking or spasms of the eyelid
  • sticking out of tongue
  • trouble with breathing
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual facial expressions

Some side effects of ziprasidone 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

  • Acid or sour stomach
  • belching
  • constipation
  • diarrhea
  • heartburn
  • indigestion
  • lack or loss of strength
  • nausea
  • rash
  • stomach discomfort, upset, or pain
  • weakness
  • weight gain

Less common

  • Blistering, crusting, irritation, itching, or reddening of the skin
  • burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • change in vision
  • cracked, dry, or scaly skin
  • depression
  • difficulty with moving
  • dry mouth
  • increase in salivation
  • itching or reddening of the skin
  • joint pain
  • loss of appetite
  • muscle ache
  • muscle pains or stiffness
  • muscle tightness
  • stuffy nose
  • swelling
  • swollen joints
  • vomiting
  • weakness of the arms and legs
  • weight loss

For Healthcare Professionals

Applies to ziprasidone: intramuscular powder for injection, oral capsule

General

The most commonly reported adverse events included somnolence, respiratory tract infections, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting, headache, and nausea.

Metabolic

Uncommon (0.1% to 1%): Thirst, increased appetite, hypercholesteremia, dehydration, hyperglycemia, hypokalemia

Weight gain of 7% or more was statistically significantly greater among patients with schizophrenia receiving ziprasidone in a pooled analysis of four 4 and 6 week placebo-controlled trials (10% versus 4%). The median weight gain was 0.5 kg among all ziprasidone patients compared with no weight gain in the placebo patients.

Nervous system

Very common (10% or more): Headache (18%), extrapyramidal symptoms (31%), somnolence (14%)

Common (1% to 10%): Akathisia, dizziness, dyskinesia, dystonia, headache, sedation, tremor, hypertonia, speech disorder

Uncommon (0.1% to 1%): Ataxia, bradykinesia, cogwheel rigidity, disturbance in attention, dizziness postural, drooling, dysarthria, generalized tonic-clonic seizures, hyperkinesia, hypersomnia, hypoesthesia, lethargy, oculogyric crisis, paresthesia, tardive dyskinesia, amnesia, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy

Rare (less than 0.1%): Akinesis, paresis, restless legs syndrome, torticollis, paralysis

Postmarketing reports: Facial droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic products), tardive dyskinesia

Gastrointestinal

Common (1% to 10%): Constipation, dry mouth, nausea, thick tongue, vomiting, dyspepsia, diarrhea, anorexia

Postmarketing reports: Dysphagia, swollen tongue

Respiratory

Common (1% to 10%): Respiratory tract infection, increased cough, rhinitis

Uncommon (0.1% to 1%): Dyspnea, sore throat, pneumonia, epistaxis

Rare (less than 0.1%): Hiccups, hemoptysis, laryngismus

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although ziprasidone was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Ziprasidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Cardiovascular

Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug-treated patient than in the placebo-treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Although ziprasidone (the active ingredient contained in Geodon) was not included in these studies, the consistent findings across all three relevant chemical classes support the opinion that these findings are likely to be applicable to all atypical antipsychotic agents. Ziprasidone is not indicated for use in the treatment of behavioral disorders in elderly patients with dementia.

In a study evaluating the QT prolonging effect of oral ziprasidone with other drugs used in the treatment of schizophrenia, the mean increase in QTc from baseline ranged from 9 to 14 seconds which was greater than 4 of the comparator drugs (risperidone, olanzapine, quetiapine, and haloperidol) but was approximately 14 seconds less than thioridazine.

Common (1% to 10%): Chest pain, tachycardia, postural hypotension, hypertension

Rare (less than 0.1%): ECG QTc prolonged, increased pulse, first degree AV block, bundle branch block, phlebitis, pulmonary embolism, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis

Postmarketing reports: Torsades de pointes, postural hypotension, hypotension, syncope, venous thromboembolism

Hypersensitivity

Postmarketing reports: Allergic reaction

Dermatologic

Common (1% to 10%): Rash, fungal dermatitis, face edema, photosensitivity reaction, sweating

Uncommon (0.1% to 1%): Acne, maculopapular rash, urticaria, eczema, exfoliative dermatitis, vesiculobullous rash

Rare (less than 0.1%): Alopecia, dermatitis allergic, erythema, psoriasis, skin irritation, swelling face, rash papular

Frequency not reported: Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome

Postmarketing reports: Angioedema, rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Psychiatric

Common (1% to 10%): Restlessness, insomnia, agitation

Uncommon (0.1% to 1%): Anxiety, throat tightness, nightmare

Rare (less than 0.1%): Anorgasmia, bradyphrenia, flat affect, panic attack, sleep walking

Postmarketing reports: Mania/hypomania

Ocular

Common (1% to 10%): Blurred vision, abnormal vision

Uncommon (0.1% to 1%): Photophobia, conjunctivitis, dry eyes, blepharitis, cataract

Endocrine

Uncommon (0.1% to 1%): Impotence, abnormal ejaculation, female lactation,

Rare (less than 0.1%): Erectile dysfunction, increased erection, galactorrhea, gynecomastia, hypothyroidism, hyperthyroidism, thyroiditis, female sexual dysfunction

Postmarketing reports: Priapism

Musculoskeletal

Common (1% to 10%): Musculoskeletal stiffness, myalgia

Uncommon (0.1% to 1%): Joint stiffness, muscle cramps, extremity pain, tenosynovitis

Rare (less than 0.1%): Arthropathy, musculoskeletal discomfort, trismus, myopathy

Genitourinary

Rare (less than 0.1%): vaginal hemorrhage, nocturia, oliguria, uterine hemorrhage

Postmarketing reports: Enuresis, urinary incontinence

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy

Rare (less than 0.1%): Lymphopenia, increased eosinophil count, abnormal eosinophil count, thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia

Hepatic

Other

Common (1% to 10%): Asthenia, accidental injury, fatigue, fever, chills, hypothermia

Uncommon (0.1% to 1%): Abnormal gait, tinnitus

Rare (less than 0.1%): Ear pain, vertigo positional, body temperature increased

Local

Local side effects associated with intramuscular ziprasidone (the active ingredient contained in Geodon) have frequently included pain at the injection site.

Immunologic

Common (1% to 10%): Flu syndrome

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

2. “Product Information. Geodon (ziprasidone).” Pfizer US Pharmaceuticals, New York, NY.

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

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Related treatment guides

  • Bipolar Disorder
  • Autism
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Geodon

SIDE EFFECTS

Clinical Trials Experience

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 practice.

Clinical trials for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure.

Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.

Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed In Short-Term, Placebo-Controlled Trials With Oral Ziprasidone

The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.

Commonly Observed Adverse Reactions In Short Term-Placebo-Controlled Trials

The following adverse reactions were the most commonly observed adverse reactions associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo): Schizophrenia trials (see Table 11)

  • Somnolence
  • Respiratory Tract Infection

Bipolar trials (see Table 12)

  • Somnolence
  • Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
  • Dizziness which includes the adverse reaction terms dizziness and lightheadedness.
  • Akathisia
  • Abnormal Vision
  • Asthenia
  • Vomiting

Schizophrenia

Adverse Reactions Associated With Discontinuation Of Treatment In Short-Term, Placebo-Controlled Trials Of Oral Ziprasidone

Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients .

Adverse Reactions Occurring At An Incidence Of 2% Or More Among Ziprasidone-Treated Patients In Short-Term, Oral, Placebo-Controlled Trials

Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Table 11: Treatment-Emergent Adverse Reaction Incidence In Short-Term Oral Placebo-Controlled Trials – Schizophrenia

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone
(N=702)
Placebo
(N=273)
Body as a Whole
Asthenia 5 3
Accidental Injury 4 2
Chest Pain 3 2
Cardiovascular
Tachycardia 2 1
Digestive
Nausea 10 7
Constipation 9 8
Dyspepsia 8 7
Diarrhea 5 4
Dry Mouth 4 2
Anorexia 2 1
Nervous
Extrapyramidal Symptoms* 14 8
Somnolence 14 7
Akathisia 8 7
Dizziness** 8 6
Respiratory
Respiratory Tract Infection 8 3
Rhinitis 4 2
Cough Increased 3 1
Skin and Appendages
Rash 4 3
Fungal Dermatitis 2 1
Special Senses
Abnormal Vision 3 2
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials.
** Dizziness includes the adverse reaction terms dizziness and lightheadedness.

Dose Dependency Of Adverse Reactions In Short-Term, Fixed-Dose, Placebo-Controlled Trials

An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision.

Extrapyramidal Symptoms (EPS)

The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.

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.

Vital Sign Changes

Ziprasidone is associated with orthostatic hypotension

ECG Changes

Ziprasidone is associated with an increase in the QTc interval . In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients.

Other Adverse Reactions Observed During The Premarketing Evaluation Of Oral Ziprasidone

Following is a list of COSTART terms that reflect treatment-emergent adverse reactions as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses >4 mg/day within the database of 3834 patients. All reported reactions are included except those already listed in Table 11 or elsewhere in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it.

Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:

Frequent: – adverse reactions occurring in at least 1/100 patients (≥1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);

Infrequent: – adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)

Rare: – adverse reactions occurring in fewer than 1/1000 patients (<0.1% of patients).

Body As A Whole

Frequent abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident

Cardiovascular System

Frequent: tachycardia, hypertension, postural hypotension

Infrequent: bradycardia, angina pectoris, atrial fibrillation

Rare: first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis

Digestive System

Frequent: anorexia, vomiting

Infrequent: rectal hemorrhage, dysphagia, tongue edema

Rare: gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena

Rare: hypothyroidism, hyperthyroidism, thyroiditis

Hemic And Lymphatic System

Infrequent: anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy

Rare: thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia

Metabolic And Nutritional Disorders

Infrequent: thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia

Rare: BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemicreaction, hypomagnesemia, ketosis, respiratory alkalosis

Musculoskeletal System

Frequent: myalgia

Infrequent: tenosynovitis

Rare: myopathy

Nervous System

Frequent: agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy

Infrequent: paralysis

Rare: myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus

Respiratory System

Frequent: dyspnea

Infrequent: pneumonia, epistaxis

Rare: hemoptysis, laryngismus

Skin And Appendages

Infrequent: maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash

Special Senses

Frequent: fungal dermatitis

Infrequent: conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia

Rare: eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis

Urogenital System

Infrequent: impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria

Rare: gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage

Bipolar Disorder

Acute Treatment Of Manic Or Mixed Episodes

Adverse Reactions Associated With Discontinuation Of Treatment In Short Term, Placebo-Controlled Trials

Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.

Adverse Reactions Occurring At An Incidence Of 2% Or More Among Ziprasidone-Treated Patients In Short-Term, Oral, Placebo-Controlled Trials

Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Table 12: Treatment-Emergent Adverse Reactions Incidence In Short-Term Oral Placebo-Controlled Trials – Manic and Mixed Episodes Associated with Bipolar Disorder

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone
(N=279)
Placebo
(N=136)
Body as a Whole
Headache 18 17
Asthenia 6 2
Accidental Injury 4 1
Cardiovascular
Hypertension 3 2
Digestive
Nausea 10 7
Diarrhea 5 4
Dry Mouth 5 4
Vomiting 5 2
Increased Salivation 4 0
Tongue Edema 3 1
Dysphagia 2 0
Musculoskeletal
Myalgia 2 0
Nervous
Somnolence 31 12
Extrapyramidal Symptoms* 31 12
Dizziness** 16 7
Akathisia 10 5
Anxiety 5 4
Hypesthesia 2 1
Speech Disorder 2 0
Respiratory
Pharyngitis 3 1
Dyspnea 2 1
Skin and Appendages
Fungal Dermatitis 2 1
Special Senses
Abnormal Vision 6 3
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
** Dizziness includes the adverse reaction terms dizziness and lightheadedness.

Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.

Intramuscular Ziprasidone

Adverse Reactions Occurring At An Incidence Of 1% or More Among Ziprasidone-Treated Patients In Short-Term Trials Of Intramuscular Ziprasidone

Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.

In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).

Table 13: Treatment-Emergent Adverse Reaction Incidence In Short-Term Fixed-Dose Intramuscular Trials

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone 2 mg
(N=92)
Ziprasidone 10 mg
(N=63)
Ziprasidone 20 mg
(N=41)
Body as a Whole
Headache 3 13 5
Injection Site Pain 9 8 7
Asthenia 2 0 0
Abdominal Pain 0 2 0
Flu Syndrome 1 0 0
Back Pain 1 0 0
Cardiovascular
Postural Hypotension 0 0 5
Hypertension 2 0 0
Bradycardia 0 0 2
Vasodilation 1 0 0
Digestive
Nausea 4 8 12
Rectal Hemorrhage 0 0 2
Diarrhea 3 3 0
Vomiting 0 3 0
Dyspepsia 1 3 2
Anorexia 0 2 0
Constipation 0 0 2
Tooth Disorder 1 0 0
Dry Mouth 1 0 0
Nervous
Dizziness 3 3 10
Anxiety 2 0 0
Insomnia 3 0 0
Somnolence 8 8 20
Akathisia 0 2 0
Agitation 2 2 0
Extrapyramidal Syndrome 2 0 0
Hypertonia 1 0 0
Cogwheel Rigidity 1 0 0
Paresthesia 0 2 0
Personality Disorder 0 2 0
Psychosis 1 0 0
Speech Disorder 0 2 0
Respiratory
Rhinitis 1 0 0
Skin and Appendages
Furunculosis 0 2 0
Sweating 0 0 2
Urogenital
Dysmenorrhea 0 2 0
Priapism 1 0 0

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of GEODON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following : Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors), ; Digestive System Disorders: Swollen Tongue; Reproductive System and Breast Disorders: Galactorrhea, priapism; Nervous System Disorders: Facial Droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; Skin and subcutaneous Tissue

Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); Urogenital System Disorders: Enuresis, urinary incontinence; Vascular Disorders: Postural hypotension, syncope.

Read the entire FDA prescribing information for Geodon (Ziprasidone)

Second Generation Antipsychotics Improve Sexual Dysfunction in Schizophrenia: A Randomised Controlled Trial

Abstract

The impact of antipsychotic drug treatment on sexual function was investigated during a randomised trial comparing first generation antipsychotics (FGAs) to (nonclozapine) second generation antipsychotics (SGAs). Sexual function and quality of life were (rater-blind) assessed in 42 patients with DSM-IV schizophrenia (aged 18–65) using the self-report version of the Derogatis Interview for Sexual Function (DISF-SR) and the Heinrichs Quality of Life Scale (QLS), prior to, and 12 weeks following, a change in medication from an FGA drug to either an FGA or SGA drug. SGAs significantly improved sexual function compared to FGAs. Change in sexual function was associated with change in quality of life. Where impaired sexual functioning is a distressing adverse effect of treatment with an FGA agent, consideration should be given to switching to an SGA.

1. Introduction

Sexual dysfunction is common in people with schizophrenia affecting around a half of all patients and likely to contribute to impaired quality of life . Little systematic research has been carried out to date on the sexual behaviour of schizophrenic patients and a Cochrane review recently called for further research on the management of antipsychotic treatment-related sexual dysfunction .

Patients themselves report that the sexual side effects of medication are distressing . For example, Finn and colleagues found that patients with schizophrenia rated impotence, as a treatment side effect, as worse than any symptoms of the illness itself. Men may perceive sexual dysfunction as more distressing than women , but the experience of sexual dysfunction in women with schizophrenia has been underresearched. Sexual dysfunction can be a significant reason for nonadherence to prescribed antipsychotic treatment .

The relationship between antipsychotic drugs and sexual dysfunction is mediated in part by antipsychotic blockade of pituitary D2 receptors increasing prolactin secretion, although direct correlations have not been established between raised prolactin levels and clinical symptoms . More recent studies highlight that a variety of mechanisms are likely to contribute to antipsychotic-related sexual dysfunction, including hyperprolactinaemia, sedation, and antagonism of a number of neurotransmitter receptors (α−adrenergic, dopaminergic, histaminic, and muscarinic) .

Conventional, or first generation antipsychotic (FGA) drugs are associated with sexual side effects. Ghadirian and colleagues found that up to 60% of men and 33% of women on FGAs reported changes in the quality of orgasm. A further study reported that chlorpromazine was associated with problems of orgasm and sulpiride with problems of arousal in female patients . A Cochrane review highlights increased prolactin levels seen with sulpiride treatment . Recent research demonstrates that as sulpiride is less lipophilic than other antipsychotics it has relatively high concentrations in the pituitary (outside the blood-brain barrier) compared to brain parenchyma . This means that hyperprolactinaemia is more likely to occur at clinical doses of sulpiride.

Individual second generation antipsychotic (SGA) drugs appear to be associated with less sexual dysfunction than that attributable to FGAs. One recent review concluded that risperidone had the largest impact on sexual dysfunction, followed by FGA drugs, then olanzapine, then clozapine, then quetiapine and, finally, aripiprazole . Antipsychotic drugs with high D2-binding affinity have been identified as more likely to cause sexual dysfunction and risperidone may be associated with higher prolactin elevation than other SGAs . Amisulpride is less lipophilic than risperidone or other SGAs and this may (as for sulpiride) explain why it is particularly identified with hyperprolactinaemia . Bearing in mind the limitations associated with its design, data from the SOHO study, a large observational study funded by Lilly, indicates an advantage to both olanzapine and quetiapine, compared with risperidone and FGA drugs, across areas of sexual dysfunction . A previous European study concluded that there were no real benefits of any of the SGAs over FGA treatment, apart from that seen with quetiapine in short-term trials . Further studies have confirmed the association of both quetiapine and aripiprazole with less severe sexual dysfunction.

Sexual dysfunction is a difficult area to investigate. Sexual problems may be underreported to clinicians who, in turn, may underestimate the sexual side effects of antipsychotic treatment . Researchers in the field have used a variety of assessment tools to measure sexual function, leading to difficulty when reviewing the published literature.

We set out to examine sexual dysfunction in a subgroup of participants in a large trial. Patients already taking, but unresponsive to, an FGA were randomised to change to either another FGA or a non-clozapine SGA for 12 weeks while sexual function and quality of life were assessed.

We tested two hypotheses. Firstly, that sexual dysfunction contributes measurably to reduced health-related quality of life in patients with schizophrenia. Secondly, that sexual function and hence quality of life is better in patients with schizophrenia on SGAs than FGAs.

2. Materials and Methods

Patients ( ) were treated with an FGA drug prior to randomisation into the study. The study was conducted alongside CUtLASS (Cost Utility of the Latest Antipsychotics in Severe Schizophrenia : a multicentre RCT that compared FGAs with SGA drugs. All participants of the substudy were recruited from one centre. The North West Multi-Centre Research Ethics Committee granted ethical approval with local approval obtained from each participating district.

2.1. Inclusion Criteria

Patients had a diagnosis of DSM-IV schizophrenia (and related disorders). The sample comprised patients recruited to CUtLASS ( ) and additional patients recruited from clinical practice ( ). All participants entered the study because of an identified need for a change to their FGA treatment, either because of ineffectiveness or intolerable side effects. No participants were referred because of sexual side effects. Patients were aged 18 to 65 years of both sexes. Patients receiving anticholinergic drugs were included.

2.2. Exclusion Criteria

Excluded patients included those with a diagnosis of schizoaffective disorder, patients with a comorbid history of alcohol or drug misuse within the last 12 months, and patients receiving treatment with more than one antipsychotic drug at baseline.

2.3. Randomisation

Randomisation, of all included patients, took place via a remote telephone service provided by the Medical Statistics Department at the Paterson Institute, Christie Hospital, Manchester, UK. The method of allocation was permuted blocks within strata with block sizes varying at random between four and 12. Arrangements were in place to ensure that the patient commenced their new antipsychotic drug treatment within hours of randomisation to either an FGA or an SGA drug. All subjects had a change to their antipsychotic drug and all completed the 12-week period on their assigned treatment. Randomised treatment allocation was revealed to the responsible clinician, the CUtLASS trial manager and the participant’s GP.

2.4. Measures

Primary and secondary outcome measures used, respectively, were the self-report Derogatis Interview for Sexual Function (DISF-SR) and the (rater-blinded) Quality of Life Scale (QLS) . The Derogatis interview is a widely used, brief, self report, multidimensional and gender-keyed instrument designed to measure quality of current sexual functioning across five primary domains: sexual cognition and fantasy (5 items); sexual arousal (5 items); sexual behaviour and experiences (5 items); orgasm (6 items); sexual drive and relationship (4 items). The first three of these key domains are scored using a nine-point scale (from “0” as “not at all” through to “8” as “4 or more times per day”); orgasm is scored using a five-point scale (from “0” as “not at all” to “4” as “extremely”); the fifth domain, sexual drive, and relationship, is scored using a combination of nine- and five-point scales. The aggregate total score can be used repeatedly throughout efficacy or effectiveness studies without any significant practice effects or loss of validity .

The QLS is the most widely used quality of life scale in the evaluation of psychopharmacological treatments for schizophrenia . The 21-item scale covers four domains: social relationships; instrumental role functioning; intrapsychic foundations; activities of daily life. The QLS has been shown to be both sensitive to change and of clinical relevance .

2.5. Statistical Analysis and Power

Results were analysed using SPSS version 15 to carry out analyses of covariance (ANCOVAs) and correlational analyses (Pearson’s r and Spearman’s rho). An a priori power calculation suggested that the sample size obtained would have 90% power to detect a difference of 30 points on the DISF-SR between the two treatment groups, which was selected as a difference that both appeared clinically relevant and related to previous findings of differences between treatment groups .

3. Results

Table 1 shows demographic characteristics of the two treatment groups. Thirty-one men and 11 women with a mean age of 41 years (range 18 to 57 years) were randomised.

Table 1 Demographic Characteristics.

The two groups were statistically comparable in terms of their ethnicity and age. The FGA arm had a lower median duration of illness and a higher proportion of males, compared with the SGA arm, although neither measure differed significantly between the two groups.

Table 2 shows antipsychotic drug treatment received by the two groups.

FGA Arm ( 𝑁 = 2 2 ) SGA Arm ( 𝑁 = 2 0 )
N Drug Dose range N Drug Dose range
2 Flupentixol 3–6 mg 2 Amisulpride 400 mg
1 Haloperidol 3 mg 7 Olanzapine 5–15 mg
3 Sulpiride 400–2000 mg 7 Quetiapine 100–700 mg
1 Trifluoperazine 15 mg 4 Risperidone 3–4 mg
7 Zuclopenthixol 4–20 mg
1 Flupentixol depot 40 2/52
1 Fluphenazine depot 25 2/52
1 Pipotiazine palm. 50 3/52
5 Zuclopenthixol depot 200 4/52–400 2/52

Table 2 This table shows antipsychotic drug treatment received by the two groups.

Table 3 shows sexual function scores of the two treatment groups over the two assessment time points.

Table 3 DISF-SR score.

Mean baseline total and subsection scores on the DISF-SR differed between the two groups (Table 3), but not significantly. Table 3 also shows that mean DISF-SR scores of the FGA-treated group worsened somewhat between the two time points.

There was no significant correlation between DISF-SR total score and QLS total score at baseline ( , ) and a weak (nonsignificant) correlation at week 12 ( ). The trend relationship seen by week 12 of the study resulted from a significant correlation between score on QLS subscale 1 (interpersonal relations & social network) and score on Section 3 of the DISF-SR (sexual behaviour & experience: Spearman’s , ). There was a significant correlation between change in DISF-SR total score and change in QLS total score from baseline to week 12 (Spearman’s ).

Twelve week DISF-SR total was modelled with an analysis of covariance. Final sexual function was significantly better ( ) for patients randomised to an SGA ( ), compared to patients receiving an FGA ( ), covarying for baseline score and gender. Adjusted 12-week marginal mean DISF-SR score was 58.0 in the SGA group and 37.7 in the FGA group (difference 20.3, 95% confidence interval 5.2, 35.4). Age was dropped as a covariate as it was not independently significant. There was no significant difference between groups in final QLS total ( ) or QLS subscales, covarying for gender and baseline score.

4. Discussion

Regarding the first hypothesis, sexual dysfunction did not have a straightforward relationship with reduced quality of life. It was unrelated at baseline but improvement in sexual function had a weak to moderate relationship with improving quality of life. This drove a trend-level association at final assessment. It may be that changes in sexual function have a more direct effect on quality of life than static sexual function, perhaps because over time there is a degree of adjustment to dysfunction. It is also worth noting that the QLS is an objective measure of quality of life, influenced by social function as well as participants’ subjective experience; subjective quality of life may be more strongly related.

Previous studies have linked male sexual dysfunction with poor quality of life in schizophrenia . Although our results do not confirm this, again, the QLS may not be the best type of measure to detect a relationship. Total score on the QLS may not have sufficient sensitivity to detect sexual functioning-related changes in quality of life, and there is an argument for examining subscales of the QLS and DISF-SR.

In terms of the second of our hypotheses, those who were in the SGA group had significantly better sexual function by the end of the trial. This suggests that switching from an FGA to an SGA can improve sexual function significantly. Note that none of the participants were referred into the study because of the sexual side effects of antipsychotic drug treatment. Sexual side effects can lessen with time following a treatment switch . This reduction over time could, in part, explain the improvement in sexual function seen in the SGA group but fails to account for the deterioration seen in the FGA group.

The study had a number of limitations. As stated earlier, the nature of the QLS, being determined largely by the deficit symptoms of schizophrenia , may explain the lack of effect of drug type on measured quality of life. Other treatment-related side effects, such as parkinsonism or sedation, which may also affect sexual function, were not measured in the study. The relatively small sample size did not permit an analysis of individual drugs. At the time of the study, some SGA drugs, such as ziprasidone and paliperidone, were not available in the UK, whilst others, such as zotepine, were little used. Female patients made up a relatively small proportion of those recruited limiting the generalisability of the findings. The study did, however, have the advantage of being a prospective, randomised comparison, one of a few to assess sexual function comprehensively. The self-report Derogatis scale was selected for this study because of its high validity and reliability.

These findings add to the evidence that SGA drugs, as a group, have less adverse sexual side effects than those associated with FGA treatment. As an RCT of a change in medication it confirms the implication of existing nonrandomised survey data that switching antipsychotics can reduce the risk of treatment-associated sexual dysfunction . Of course, it is not clear what effect switching within SGAs or from SGA to FGA would be, so it is uncertain whether this is an effect of switching class.

5. Conclusions

Switching from FGAs to SGAs improved sexual function compared to switching within FGAs. The relationship between the self-report measure of sexual function and the assessor-rated, objective quality of life measure used was complex, but it appeared that change in sexual function was associated with change in quality of life. Where impaired sexual functioning is a distressing adverse effect of treatment with an FGA agent consideration should be given to switching to an SGA.

Acknowledgments

This study was conducted alongside the CUtLASS trials (Cost utility of the latest antipsychotics in severe schizophrenia, ) which were funded by NHS R&D Health Technology Assessment. The authors are grateful to reviewers for their comments on an earlier draft of this paper.

Generic Name: ziprasidone (zi PRAY si done)
Brand Names: Geodon

Medically reviewed by Kaci Durbin, MD Last updated on Feb 15, 2019.

  • Overview
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What is Geodon?

Geodon (ziprasidone) is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Geodon is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old. It is available as an oral (by mouth) treatment as an injection.

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

Important information

You should not use Geodon if you have a heart rhythm disorder, a history of long QT syndrome, uncontrolled heart failure, if you have recently had a heart attack, or if you are allergic to Geodon or ziprasidone.

Some medicines can cause unwanted or dangerous effects when used with Geodon, and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Stop taking Geodon and call your doctor right away if you have a chest pain, severe dizziness, and a fast or pounding heartbeat. These could be signs of a serious heart rhythm problem.

Stop taking Geodon and call your doctor right away if you have severe muscle pains, muscle spasms, fevers, sweating, or confusion.

Stop using this medicine and call your doctor right away if you have a new or worsening skin rash with fever or swollen glands.

Tell your doctor if you experience prolonged diarrhea or loose stools while taking Geodon.

Before taking this medicine

You should not use Geodon if you are allergic to ziprasidone, or if you have:

  • a heart rhythm disorder;

  • a personal or family history of long QT syndrome;

  • uncontrolled or untreated heart failure; or

  • if you have recently had a heart attack.

Geodon is not approved for use in psychotic conditions related to dementia. Geodon may increase the risk of death in older adults with dementia-related conditions.

Geodon should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur:

  • anagrelide;

  • methadone;

  • tacrolimus;

  • certain anti-nausea medicines including dolasetron, droperidol, or ondansetron;

  • the antibiotics azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and pentamidine;

  • certain cancer medicines such as arsenic trioxide and vandetanib;

  • the antidepressants citalopram, escitalopram;

  • anti-malaria medications including chloroquine, halofantrine, mefloquine;

  • the following heart rhythm medicines – amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or

  • certain anti-psychotics such as chlorpromazine, haloperidol, mesoridazine, pimozide, and thioridazine.

This list is not complete and there may be other drugs that should not be taken at the same time as Geodon. Tell your doctor about all medicines you use.

To make sure Geodon is safe for you, tell your doctor if you have ever had:

  • any heart problems;

  • a heart attack or stroke;

  • a bone marrow or blood cell disorder;

  • breast cancer;

  • low blood levels of potassium or magnesium;

  • diabetes (ziprasidone may raise your blood sugar);

  • seizures or epilepsy;

  • suicidal thoughts;

  • Alzheimer’s disease;

  • trouble swallowing;

  • liver disease; or

  • kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking Geodon, do not stop taking it without your doctor’s advice.

It is not known whether Geodon passes into breast milk or if it could harm a nursing baby. Talk to your doctor about Geodon if you are planning to breastfeed.

Older adults may be more sensitive to the effects of this medicine.

Geodon is not approved for use by anyone younger than 18 years old.

How should I take Geodon?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with food. Swallow the capsule whole.

While using Geodon, you may need frequent blood tests to check your kidney or liver function may.

If you are diabetic, check your blood sugar levels on a regular basis while you are taking Geodon.

Use Geodon regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Do not stop using Geodon suddenly, even if you feel fine. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, light, and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include cause excessive sleepiness, slurred speech, high blood pressure, shaking, tremors, or anxiety.

While you are taking Geodon, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Geodon.

Geodon may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Geodon side effects

Get emergency medical help if you have signs of an allergic reaction to Geodon: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using ziprasidone.

Also call your doctor at once if you have:

  • dizziness or a light-headed feeling, like you might pass out;

  • chest pain, fast or pounding heartbeats;

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

  • sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, pain when swallowing;

  • increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • very stiff (rigid) muscles, high fever, sweating, confusion, agitation.

Common Geodon side effects may include:

  • dizziness, drowsiness, unusual tiredness;

  • nausea, upset stomach;

  • diarrhea, constipation;

  • changes in vision;

  • feeling restless;

  • tremors or twitching;

  • rash; or

  • runny nose, new or worsening cough.

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 other drugs will affect Geodon?

Taking Geodon with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Geodon should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur;

  • anagrelide;

  • methadone;

  • tacrolimus;

  • certain anti-nausea medicines including dolasetron, droperidol, or ondansetron;

  • the antibiotics azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, and pentamidine;

  • certain cancer medicines such as arsenic trioxide and vandetanib;

  • the antidepressants citalopram and escitalopram;

  • anti-malaria medications including chloroquine, halofantrine, mefloquine;

  • the following heart rhythm medicines – amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, quinidine, sotalol; or;

  • certain anti-psychotics such as chlorpromazine, haloperidol, mesoridazine, pimozide, and thioridazine;

Many other drugs can interact with Geodon. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Geodon. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Geodon only for the indication prescribed.

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

Copyright 1996-2020 Cerner Multum, Inc. Version: 12.03.

Medical Disclaimer

Brand Names: Geodon

Generic Name: ziprasidone

  • What is ziprasidone (Geodon)?
  • What are the possible side effects of ziprasidone (Geodon)?
  • What is the most important information I should know about ziprasidone (Geodon)?
  • What should I discuss with my healthcare provider before taking ziprasidone (Geodon)?
  • How should I take ziprasidone (Geodon)?
  • What happens if I miss a dose (Geodon)?
  • What happens if I overdose (Geodon)?
  • What should I avoid while taking ziprasidone (Geodon)?
  • What other drugs will affect ziprasidone (Geodon)?
  • Where can I get more information (Geodon)?

What is ziprasidone (Geodon)?

Ziprasidone is an antipsychotic medicine that is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression).

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

What are the possible side effects of ziprasidone (Geodon)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using ziprasidone.

Stop using ziprasidone and 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);
  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
  • any skin rash, no matter how mild;
  • low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough, trouble breathing;
  • high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor; or
  • severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, agitation.

Common side effects may include:

  • dizziness, drowsiness, weakness;
  • nausea, vomiting;
  • trouble swallowing;
  • feeling restless;
  • tremors;
  • vision problems; or
  • runny nose, new or worsening cough.

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 ziprasidone (Geodon)?

You should not use this medicine if you have a heart rhythm disorder, long QT syndrome, uncontrolled heart failure, or if you have recently had a heart attack.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Stop taking ziprasidone and call your doctor right away if you have sudden dizziness, fast or pounding heartbeats, fluttering in your chest, shortness of breath, or a new or worsening skin rash with fever, or swollen glands.

Ziprasidone may increase the risk of death in older adults with dementia-related conditions and is not approved for this use.

What is Geodon?

Geodon is a medication known as an atypical antipsychotic that is used to treat symptoms of schizophrenia. The medication is also sometimes used to treat symptoms of bipolar disorder.

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

Geodon was first approved by the FDA in 2001.

Is there a generic version of Geodon?

Yes, ziprasidone is the generic version of Geodon and is available in the United States.

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

Geodon belongs to the class of medications known as atypical antipsychotics or second generation psychotics. It is available in tablet and intramuscular injection form. The drug is also used to treat symptoms of bipolar disorder. 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 Geodon?

The safety and efficacy of the medication in persons younger than 18 has not been established.

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

There are hundreds of other drugs which are known to interact with Geodon in major, moderate, or mild ways. Some of these include amiodarone, arsenic trioxide, chlorpromazine, disopyramide, dofetilide, dolasetron, dronedarone, droperidol, halofantrine, ibutilide, mefloquine, moxifloxacin, pentamidine, pimozide, procainamide, quinidine, sotalol, tacrolimus, and thioridazine. Let your doctor know what other prescription and nonprescription medications you are taking before you begin taking the medication.

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

Talk to your doctor about other medical conditions before you take Geodon, such as a prolonged QT interval, diabetes, dementia, seizures, low white blood cell count, high cholesterol, high or low blood pressure, a history of heart attack or stroke, breast cancer, heart 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 Geodon?

The FDA recommends a starting dosage of 20mg twice a day for the treatment of schizophrenia. Safety and efficacy has not been established beyond a dosage of 100mg twice a day. Dosage may differ for the intramuscular injection version of the medication and for the treatment of bipolar disorder.

What do I do if I miss a dose?

Take the dose of Geodon 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.

Are there common side effects from taking Geodon?

Common side effects of Geodon can include:

  • Restlessness
  • Anxiety
  • Fatigue
  • Headaches
  • Loss of appetite
  • Diarrhea
  • Stomach pain
  • Muscle pain
  • Weight gain
  • Headaches
  • Constipation
  • Runny nose
  • Cough
  • Late or missed menstrual periods
  • Breast enlargement or discharge
  • Decreased sexual ability.

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 rash or hives, peeling of skin, itching, irregular or fast heartbeat, swollen glands, mouth sores, fever, muscle stiffness, confusion, sweating, painful erection, uncontrollable facial or body movements, and loss of consciousness. 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 Geodon?

Your doctor should monitor for progression of potential long-term side effect of Geodon, which can include changes in heart rhythm, weight gain, high blood sugar, and tardive dyskinesia.

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

There have been no controlled human pregnancy studies on the effects of Geodon. It is not known whether the drug can be transferred via human breast milk, but patients are advised not to breastfeed while taking the medication. Therefore, if you are pregnant, planning to become pregnant, or are nursing, talk to your doctor before you take Geodon.

Can symptoms occur if Geodon is discontinued?

It’s important not to discontinue use of the drug if you feel better. Withdrawal symptoms may include nausea, vomiting, tremors, increased heart rate, headaches, dizziness, and the return of symptoms of schizophrenia. Maintain contact with your doctor and seek medical attention if necessary when discontinuing the drug, and talk to your doctor about how to mitigate potential withdrawal symptoms.

What should I do if I overdose on Geodon?

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 restlessness, tremors, stiffness, sleepiness, nervousness, and changes in heartbeat.

Is Geodon habit-forming?
Geodon 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 Geodon cost?

According to goodrx.com, 30 tablets of 40mg Geodon cost approximately $500. 30 tablets of 40mg generic ziprasidone cost approximately $154.

Are there any disadvantages to Geodon?

The biggest disadvantages of Geodon are the potential long-term side effects, which can include tardive dyskinesia, changes in heart rhythms, increased blood sugar, 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

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