Does eliquis cause weight gain

Eliquis Side Effects

Generic Name: apixaban

Medically reviewed by Drugs.com. Last updated on Jan 17, 2019.

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

For the Consumer

Applies to apixaban: oral tablet

Warning

Oral route (Tablet)

Premature discontinuation of apixaban or any oral anticoagulant increases the risk of thrombotic events. Consider an alternative anticoagulant if apixaban treatment is discontinued for any reason other than pathological bleeding or treatment completion. In patients undergoing neuraxial anesthesia or spinal puncture, epidural or spinal hematoma risk is increased and could result in long-term or permanent paralysis. The optimal timing between dosing apixaban and neuraxial procedures is unknown. Monitor patients for signs and symptoms of neurologic impairment and treat urgently. Consider the benefits and risks of neuraxial intervention in patients who are or need to be anticoagulated.

Along with its needed effects, apixaban (the active ingredient contained in Eliquis) 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 apixaban:

Rare

  • Blood in the eyes
  • blood in the urine
  • bloody or black, tarry stools
  • bruising or purple areas on the skin
  • confusion
  • constipation
  • coughing up blood
  • decreased alertness
  • difficulty swallowing
  • dizziness
  • fainting
  • fast heartbeat
  • headache
  • hives, itching, skin rash
  • joint pain or swelling
  • nausea and vomiting
  • nosebleeds
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the eye
  • severe stomach pain
  • shortness of breath
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds

For Healthcare Professionals

Applies to apixaban: oral tablet

General

The most common adverse events were related to bleeding. Common adverse reactions were anemia, hemorrhage, and nausea.

Hematologic

Very common (10% or more): Minor bleed (11.7%)

Common (1% to 10%): Anemia postoperative, clinically relevant nonmajor bleed, hemoglobin decreased, anemia, hemorrhage

Uncommon (0.1% to 1%): Postprocedural hemorrhage, hemoglobin decrease of 2 g/dL or more, transfusion of 2 units or more red blood cells, fatal bleed, thrombocytopenia, hemorrhagic anemia

Rare (less than 0.1%): Bleed at critical site

Patients with diabetes had more bleeding events than non-diabetic subjects. Hemorrhage includes hematoma, and vaginal and urethral hemorrhage. Postprocedural hemorrhage includes postprocedural hematoma, wound hemorrhage, vessel puncture site hematoma, and catheter site hemorrhage.

Gastrointestinal

Very common (10% or more): Nausea (14.1%)

Common (1% to 10%): Constipation, vomiting, diarrhea, abdominal pain upper, abdominal pain, dyspepsia, gastritis, gastroenteritis, toothache, gingival bleeding, rectal hemorrhage, dyspepsia, gastrointestinal hemorrhage (including hematemesis and melena),

Uncommon (0.1% to 1%): Major gastrointestinal bleed, hematochezia, hemorrhoidal hemorrhage, hematemesis, melena, anal hemorrhage, occult blood positive, occult blood, intra-abdominal hemorrhage, mouth hemorrhage

Rare (less than 0.1%): Retroperitoneal hemorrhage

Cardiovascular

Common (1% to 10%): Hypotension, peripheral edema, atrial fibrillation, cardiac failure, hypertension, deep vein thrombosis, tachycardia, cardiac failure congestive, palpitations, thrombosis, angina pectoris, bradycardia, blood pressure increased, procedural hypotension, unstable angina, tachycardia

Nervous system

Common (1% to 10%): Dizziness, headache, fatigue, syncope, ischemic stroke, vertigo

Uncommon (0.1% to 1%): Somnolence, cerebrovascular accident, transient ischemic attack, major intracranial bleed, brain hemorrhage, other intracranial or intraspinal hemorrhage (including subdural hematoma, subarachnoid hemorrhage, and spinal hematoma)

Frequency not reported: Stroke

Local

Common (1% to 10%): Hematoma, wound hemorrhage, wound secretion

Uncommon (0.1% to 1%): Incision-site hemorrhage, operative hemorrhage, traumatic hematoma, injection site hematoma, vessel puncture site hematoma, application site bleeding, traumatic hemorrhage

Ocular

Common (1% to 10%): Cataract, conjunctival hemorrhage, eye hemorrhage

Uncommon (0.1% to 1%): Major intraocular bleed, periorbital hematoma, conjunctival hemorrhage, retinal hemorrhage

Frequency not reported: Ocular hemorrhage

Respiratory

Common (1% to 10%): Nasopharyngitis, dyspnea, epistaxis, bronchitis, cough, upper respiratory tract infection, influenza, pneumonia, sinusitis, chronic obstructive pulmonary disease, lower respiratory tract infection, hemoptysis, dyspnea exertional, respiratory tract infection

Uncommon (0.1% to 1%): Dyspnea

Rare (less than 0.1%): Pulmonary embolism, respiratory tract hemorrhage (including pulmonary alveolar hemorrhage, laryngeal hemorrhage, and pharyngeal hemorrhage)

Other

Very common (10% or more): Procedural pain (10.3%)

Common (1% to 10%): Pyrexia, chest pain, fall, asthenia, blood creatine phosphokinase increased, pain, body temperature increased, laceration, chest discomfort, tooth extraction

Uncommon (0.1% to 1%): Herpes zoster

Genitourinary

Common (1% to 10%): Urinary tract infection, menorrhagia

Uncommon (0.1% to 1%): vaginal hemorrhage, metrorrhagia, menometrorrhagia, genital hemorrhage, blood urine present, red blood cells urine positive, abnormal vaginal hemorrhage, urogenital hemorrhage

Renal

Common (1% to 10%): Hematuria, blood creatinine increased, renal failure

Musculoskeletal

Uncommon (0.1% to 1%): Muscle hemorrhage, joint swelling

Metabolic

Common (1% to 10%): Gout, diabetes mellitus, blood glucose increased, hyperglycemia, hypokalemia, decreased appetite

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity (including drug hypersensitivity such as skin rash and anaphylactic reaction such as allergic edema)

Hepatic

Uncommon (0.1% to 1%): Transaminases increased, AST increased, ALT increased, gamma-glutamyl transferase increased, liver function test abnormal, blood alkaline phosphatase increased, blood bilirubin increased

Psychiatric

Common (1% to 10%): Insomnia, depression

Uncommon (0.1% to 1%): Anxiety

Dermatologic

Common (1% to 10%): Pruritus, contusion, rash, cellulitis, ecchymosis, erythema, blister

Uncommon (0.1% to 1%): Skin hemorrhage, petechiae, skin rash

Oncologic

Uncommon (0.1% to 1%): Basal cell carcinoma

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

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

3. “Product Information. Eliquis (apixaban).” Bristol-Myers Squibb Canada Inc, Montreal, IN.

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 Eliquis (apixaban)

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Related treatment guides

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  • … +4 more

Eliquis

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information.

  • Increased risk of thrombotic events after premature discontinuation
  • Bleeding
  • Spinal/epidural anesthesia or puncture

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.

Reduction Of Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

The safety of ELIQUIS was evaluated in the ARISTOTLE and AVERROES studies , including 11,284 patients exposed to ELIQUIS 5 mg twice daily and 602 patients exposed to ELIQUIS 2.5 mg twice daily. The duration of ELIQUIS exposure was ≥12 months for 9375 patients and ≥24 months for 3369 patients in the two studies. In ARISTOTLE, the mean duration of exposure was 89 weeks (>15,000 patient-years). In AVERROES, the mean duration of exposure was approximately 59 weeks (>3000 patient-years).

The most common reason for treatment discontinuation in both studies was for bleeding-related adverse reactions; in ARISTOTLE this occurred in 1.7% and 2.5% of patients treated with ELIQUIS and warfarin, respectively, and in AVERROES, in 1.5% and 1.3% on ELIQUIS and aspirin, respectively.

Bleeding in Patients with Nonvalvular Atrial Fibrillation in ARISTOTLE and AVERROES

Tables 1 and 2 show the number of patients experiencing major bleeding during the treatment period and the bleeding rate (percentage of subjects with at least one bleeding event per 100 patient-years) in ARISTOTLE and AVERROES.

Table 1: Bleeding Events in Patients with Nonvalvular Atrial Fibrillation in ARISTOTLE*

In ARISTOTLE, the results for major bleeding were generally consistent across most major subgroups including age, weight, CHADS2 score (a scale from 0 to 6 used to estimate risk of stroke, with higher scores predicting greater risk), prior warfarin use, geographic region, and aspirin use at randomization (Figure 1). Subjects treated with apixaban with diabetes bled more (3.0% per year) than did subjects without diabetes (1.9% per year).

Figure 1: Major Bleeding Hazard Ratios by Baseline Characteristics – ARISTOTLE Study

Note: The figure above presents effects in various subgroups, all of which are baseline characteristics and all of which were prespecified, if not the groupings. The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.

Table 2: Bleeding Events in Patients with Nonvalvular Atrial Fibrillation in AVERROES

Other Adverse Reactions

Hypersensitivity reactions (including drug hypersensitivity, such as skin rash, and anaphylactic reactions, such as allergic edema) and syncope were reported in <1% of patients receiving ELIQUIS.

Prophylaxis Of Deep Vein Thrombosis Following Hip Or Knee Replacement Surgery

The safety of ELIQUIS has been evaluated in 1 Phase II and 3 Phase III studies including 5924 patients exposed to ELIQUIS 2.5 mg twice daily undergoing major orthopedic surgery of the lower limbs (elective hip replacement or elective knee replacement) treated for up to 38 days.

In total, 11% of the patients treated with ELIQUIS 2.5 mg twice daily experienced adverse reactions.

Bleeding results during the treatment period in the Phase III studies are shown in Table 3. Bleeding was assessed in each study beginning with the first dose of double-blind study drug.

Table 3: Bleeding During the Treatment Period in Patients Undergoing Elective Hip or Knee Replacement Surgery

Adverse reactions occurring in ≥1% of patients undergoing hip or knee replacement surgery in the 1 Phase II study and the 3 Phase III studies are listed in Table 4.

Table 4: Adverse Reactions Occurring in ≥1% of Patients in Either Group Undergoing Hip or Knee Replacement Surgery

Less common adverse reactions in apixaban-treated patients undergoing hip or knee replacement surgery occurring at a frequency of ≥0.1% to <1%:

Blood and lymphatic system disorders: thrombocytopenia (including platelet count decreases)

Vascular disorders: hypotension (including procedural hypotension)

Respiratory, thoracic, and mediastinal disorders: epistaxis

Gastrointestinal disorders: gastrointestinal hemorrhage (including hematemesis and melena), hematochezia

Hepatobiliary disorders: liver function test abnormal, blood alkaline phosphatase increased, blood bilirubin increased

Renal and urinary disorders: hematuria (including respective laboratory parameters)

Injury, poisoning, and procedural complications: wound secretion, incision-site hemorrhage (including incision-site hematoma), operative hemorrhage

Less common adverse reactions in apixaban-treated patients undergoing hip or knee replacement surgery occurring at a frequency of <0.1%:

Gingival bleeding, hemoptysis, hypersensitivity, muscle hemorrhage, ocular hemorrhage (including conjunctival hemorrhage), rectal hemorrhage

Treatment Of DVT And PE And Reduction In The Risk Of Recurrence Of DVT Or PE

The safety of ELIQUIS has been evaluated in the AMPLIFY and AMPLIFY-EXT studies, including 2676 patients exposed to ELIQUIS 10 mg twice daily, 3359 patients exposed to ELIQUIS 5 mg twice daily, and 840 patients exposed to ELIQUIS 2.5 mg twice daily.

Common adverse reactions (≥1%) were gingival bleeding, epistaxis, contusion, hematuria, rectal hemorrhage, hematoma, menorrhagia, and hemoptysis.

AMPLIFY Study

The mean duration of exposure to ELIQUIS was 154 days and to enoxaparin/warfarin was 152 days in the AMPLIFY study. Adverse reactions related to bleeding occurred in 417 (15.6%) ELIQUIS-treated patients compared to 661 (24.6%) enoxaparin/warfarin-treated patients. The discontinuation rate due to bleeding events was 0.7% in the ELIQUIS-treated patients compared to 1.7% in enoxaparin/warfarin-treated patients in the AMPLIFY study.

Bleeding results from the AMPLIFY study are summarized in Table 5.

Table 5: Bleeding Results in the AMPLIFY Study

Adverse reactions occurring in ≥1% of patients in the AMPLIFY study are listed in Table 6.

Table 6: Adverse Reactions Occurring in ≥1% of Patients Treated for DVT and PE in the AMPLIFY Study

AMPLIFY-EXT Study

The mean duration of exposure to ELIQUIS was approximately 330 days and to placebo was 312 days in the AMPLIFY-EXT study. Adverse reactions related to bleeding occurred in 219 (13.3%) ELIQUIS-treated patients compared to 72 (8.7%) placebo-treated patients. The discontinuation rate due to bleeding events was approximately 1% in the ELIQUIS-treated patients compared to 0.4% in those patients in the placebo group in the AMPLIFY-EXT study.

Bleeding results from the AMPLIFY-EXT study are summarized in Table 7.

Table 7: Bleeding Results in the AMPLIFY-EXT Study

Adverse reactions occurring in ≥1% of patients in the AMPLIFY-EXT study are listed in Table 8.

Table 8: Adverse Reactions Occurring in ≥1% of Patients Undergoing Extended Treatment for DVT and PE in the AMPLIFY-EXT Study

Other Adverse Reactions

Less common adverse reactions in ELIQUIS-treated patients in the AMPLIFY or AMPLIFY-EXT studies occurring at a frequency of ≥0.1% to <1%:

Blood and lymphatic system disorders: hemorrhagic anemia

Gastrointestinal disorders: hematochezia, hemorrhoidal hemorrhage, gastrointestinal hemorrhage, hematemesis, melena, anal hemorrhage

Injury, poisoning, and procedural complications: wound hemorrhage, postprocedural hemorrhage, traumatic hematoma, periorbital hematoma

Musculoskeletal and connective tissue disorders: muscle hemorrhage

Reproductive system and breast disorders: vaginal hemorrhage, metrorrhagia, menometrorrhagia, genital hemorrhage

Vascular disorders: hemorrhage

Skin and subcutaneous tissue disorders: ecchymosis, skin hemorrhage, petechiae

Eye disorders: conjunctival hemorrhage, retinal hemorrhage, eye hemorrhage

Investigations: blood urine present, occult blood positive, occult blood, red blood cells urine positive

General disorders and administration-site conditions: injection-site hematoma, vessel puncture-site hematoma

Read the entire FDA prescribing information for Eliquis (Apixaban Tablets)

7 Things to Know About Taking Blood Thinners Safely

If you’ve been diagnosed with an abnormal heart rhythm, such as atrial fibrillation or afib, your doctor may recommend taking blood thinners, also called anticoagulants. These medications reduce the blood’s ability to clot, lowering your risk of stroke.

Your body creates clots to stop you from bleeding. If you fall or bump your head while taking a blood thinner, you may have internal bleeding – even if there’s no external sign you’ve been hurt.

Dr. Matthew Cozart with Mercy Clinic Cardiology has 7 things you should know about blood thinners:

  1. They can make you feel green. Aside from bleeding-related issues, there are several side effects that have been linked to blood thinners, such as nausea and low counts of cells in your blood. Low blood cell count can cause fatigue, weakness, dizziness and shortness of breath.
  2. Be careful mixing medications. Some antibiotics and anti-fungal medications can make blood thinners more potent and increase the risk of bleeding. Talk to your Mercy doctor before you combine any medicines – including over-the-counter – or supplements.
  3. Tell all of your health care providers that you’re taking blood thinners. Even your dentist. If you use different pharmacies, make sure all your pharmacists know.
  4. Never skip a dose. Always take your blood thinner as directed by your doctor. Some need to be taken every day at the same time. Don’t skip a dose and don’t double up. If you miss one, take it as soon as you remember. If you don’t remember until the next day, call your doctor. Try using a daily pillbox to help keep you on track.
  5. Watch for evidence of internal bleeding. Slow bleeding can cause fatigue, shortness of breath, pale skin color and black, tarry-looking stools. Rapid bleeding can cause stroke symptoms or abdominal and back pain, depending on where you’re bleeding.
  6. Take it easy. It’s important to take precautions to minimize the risk of falls or trauma that could potentially cause significant bleeding. Talk to your doctor about whether it’s okay to participate in activities that are higher risk, such as snow skiing or mountain biking.
  7. Avoid drinking alcohol. Your liver is responsible for processing alcohol and some medications. If it’s breaking down alcohol instead of the blood thinner, the level of medicine in your blood can increase.

There are lots of options for blood thinners. Your doctor will take into account your health history, age, weight and kidney and liver function before determining which blood thinner might work best for you.

Warfarin is usually well tolerated and inexpensive, but you must monitor how thin your blood is with frequent lab work. Some foods also decrease its effectiveness, so it’s important to keep your diet consistent. New oral anticoagulants, or NOACs, don’t require regular blood work or diet management. However, they can’t be taken with certain heart valve problems.

Some people worry about bruising while taking blood thinners. Dr. Cozart says while this can be concerning, it’s usually not dangerous and is just an unfortunate side effect of a medication that is providing important protection from stroke.

Talk to your Mercy doctor about which blood thinner, if any, is right for you.

Matthew Cozart, MD, is a fellowship-trained interventional cardiologist at Mercy Clinic Cardiology in Rogers, AR, and Bella Vista, AR. To schedule an appointment in Rogers, call 479-338-4400. For Bella Vista, call 479-802-5588.

PMC

Discussion

New (novel)/direct oral anticoagulants (NOACs, DOACs) that act through reversible factor Xa inhibition (rivaroxaban, apixaban, edoxaban) are now commonly used in lieu of warfarin in a number of clinical settings. Primary clinical trials contributing to their Food and Drug Administration (FDA) approvals also assessed for safety signals for hemorrhage risk. In comparison to warfarin, these drugs appeared therapeutically non-inferior, and in some cases superior (for non-valvular atrial fibrillation-related stroke prophylaxis, deep vein thrombosis (DVT) prophylaxis, and DVT/pulmonary embolism treatment) and as safe or safer regarding major bleeding (intracranial, gastrointestinal) risk . Some now have a role in secondary cardiovascular prevention , yet none appear effective for all (e.g., prosthetic valve thromboembolism prophylaxis) clinical needs . These drugs do not require regular blood monitoring, and aside from the additive effects of other types of anticoagulant/antiplatelet agents, have far fewer drug-drug interactions (CYP 3A4 inhibitors/inducers , calcineurin inhibitors , P-glycoprotein inhibitors , non-steroidal anti-inflammatory drugs ) than does warfarin, and no reported interactions with food save grapefruit juice . They are easily dosed once or twice daily by strategy with few dosing adjustments required for patient-specific variables (renal dysfunction, extreme patient age, low body weight) . All are not advised in patients with severe liver disease.

Apixaban’s pharmacokinetic profile has been described including a peak single dose concentration at about 3 h; and an apparent β half-life of about 12 h after multiple dosing. The pharmacodynamic effects within a 10-fold dose range (2.5 – 25 mg twice daily) are concentration-related with low to moderate variability. Of note, AUCtau between day 1 and day 7 administration of a 5 mg twice daily dose increased by 75%. The drug is approximately 50% bioavailable after recommended dosing. Approximately 25% of an oral dose is excreted as metabolites. O-demethylation and hydroxylation is primarily performed by CYP 3A4 although other cytochrome P450 enzymes (1A2, 2C8, 2C9, 2C19, 2J2) contribute to its metabolism. Apixaban is also a substrate for the P-glycoprotein efflux transporter. Based upon these facts, the manufacturer recommends that the apixaban dose be limited to 2.5 mg twice daily in patients on strong dual inhibitors of these proteins . Despite these findings, no increase in bleeding complications were found when apixaban was co-administered with verapamil (adjusted risk ratio with versus without verapamil, 0.95 (99% CI 0.51, 1.77) . Apixaban does not appear to inhibit or induce CYP enzymes or the P-glycoprotein transporter.

The vast majority of adverse drug event (ADEs) reports for apixaban focus, as expected, on one or more manifestations of heightened bleeding risk. Reports have also been published documenting rare idiosyncratic drug-induced liver injury, which is usually but not always reversible with drug discontinuation . However, an extensive search of the peer-reviewed literature (PubMed, Google/Google Scholar) failed to identify any neurologic adverse events due to apixaban, save those associated with hemorrhage or hematoma formation. The FDA’s Adverse Reporting System Public Dashboard (accessed January 25, 2018) of reports received from 2011 to January 2018 listed 19 reports of diplopia, 163 of confusion, 27 of disorientation, 894 of dizziness, 718 of headache, and 86 of balance disorders . As stated on this official web site, these reports may have significant “…limitations, including incomplete, inaccurate, untimely, unverified information…” and that “information on this website does not confirm a causal relationship between the drug product and the reported adverse event(s)” . A major drug reference database lists pre-syncope (considered a cardiovascular effect) in < 1% of patients with non-valvular atrial fibrillation taking apixaban based on two large randomized trials/registries (ARISTOTLE , AVERROES ), but further details are not available to assess whether these patients might in fact have had complication syndromes similar to that of our patient. Other sources list dizziness, confusion and decreased alertness, or headaches but provide no supporting references, details of observed cases, or descriptions of whether a combination of these symptoms were present in any individual patients.

Several aspects of this case strongly suggest apixaban as the causative agent: 1) Suggestion of possible similar reports available on the FDA Surveillance Database; 2) Symptoms were not present prior to drug administration; 3) Symptoms began shortly after initial administration of this newly-prescribed agent; 4) Symptoms progressively worsened with continued drug consumption; 5) Symptoms resolved rapidly with drug discontinuation; 6) Symptoms recurred with (patient-initiated) re-challenge; and 7) The second episode of symptoms again resolved with drug discontinuation. CNS imaging was not considered cost-beneficial for this patient at the time of physical presentation, as the history of reproducible and totally resolving clinical symptoms made vascular or hemorrhagic events extraordinarily unlikely.

To our knowledge, this is the first case reported in the peer-reviewed literature of this particular adverse event syndrome from apixaban, as well as the first to include a drug re-challenge further supporting a causative association with the drug. Adverse drug reactions are generally classified into six categories: A) dose-dependent, augmentations of known pharmacologic activities; B) non-dose-dependent, unpredictable events not related to known pharmacology of the drug (includes immunologic/hypersensitivity and idiosyncratic reactions; implies host susceptibility through genetics or other mechanisms); C) chronic (dose- and time-related) reactions; D) delayed (time-related) reactions; E) withdrawal phenomena with drug discontinuation; and F) unexpected failure of therapy . Although the clinical timeline bore some association with the drug’s known pharmacokinetics, and possible alterations in half-life by concomitantly administered verapamil could have influenced this relationship, this relationship was not consistent and we therefore concluded that our patient’s reaction was most likely a category B (idiosyncratic/hypersensitivity) reaction. Of the four types of hypersensitivity reactions, this patient’s reaction is most consistent with Type I (immediate hypersensitivity reaction), though she had no history of prior exposure and lacked other symptoms of histamine or eicosanoid actions . Using the World Health Organization-Uppsala Monitoring Centre causality assessment scale , this patient’s reaction falls between the “Probable/likely” and “Certain” categories, with the latter identified largely due to the positive re-challenge criteria . Using the Naranjo Adverse Drug Reaction Probability Scale, our patient generates 5 points, placing this reaction in the “probable” causality category .

Few publications have attempted to summarize mechanisms of neurological adverse drug reactions. Our patient’s symptoms were not consistent with neurologic drug side effects associated with specific syndromes with known mechanisms (cerebrovascular events, elevated cholinergic activity, serotonin syndrome, idiopathic intracranial hypertension, neuroleptic malignant syndrome, akathisia, chorea, tardive syndromes, dystonic reactions, dystonia, tremor, parkinsonism) . She had no symptoms consistent with a true immunologic reaction. Hence, our patient’s reaction does not fit with available descriptions of such reactions from other drugs.

The exact mechanism of our patient’s adverse reaction is unclear, as details appear to cross standard categories. However, as these more convenient and likely superior, safer drugs become the standard of care for many large patient populations requiring chronic anticoagulation, post-marketing peer-reviewed reports of idiopathic adverse drug reactions to NOACs, such as that experienced by our patient, are critical.

Swelling in the legs caused by pooling of fluid (or edema) is a common side effect of medications. Either the medication is the primary cause of the swelling, or it’s making already swollen legs worse. If you notice that your shoes are tight or that you have puffy legs, consider when the swelling began and whether your medication is the culprit.

First, how do you determine the cause of swelling?

Gradual swelling in your legs and feet might not be obvious. But if you have imprints from your socks, puffy legs, or what’s known as pitting edema (where you can make an indent in your leg with your thumb), those are all signs that you have some extra fluid in your limbs.

Causes of leg swelling besides medication usually occur on one leg and could be caused by:

  • Deep vein thrombosis (DVT), where a blood clot blocks a blood vessel in your leg, so fluid begins to pool
  • Disease in the veins or lymph vessels
  • Heart failure
  • Sitting or standing for long periods of time

One clue that your medication could be the cause is if you have swelling on both your right and left legs (or feet). If you’re experiencing this symptom, look at this list and make sure you aren’t taking one of these 7 medications.

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1) Amlodipine

Amlodipine (Norvasc) is a medication used to lower blood pressure. The higher the dose, the more likely you are to have swelling in both of your legs and feet. One in 10 patients experience swelling when taking amlodipine at a dose of 10 mg daily. And women are almost 3 times more likely than men to have this side effect.

Other medication options exist for lowering blood pressure that don’t cause swelling in the legs. So if swelling is a problem for you, ask your doctor about switching it up.

2) Gabapentin

Gabapentin (Neurontin) is used to treat nerve pain, which often occurs after shingles (known as postherpetic neuralgia) or as a result of nerve damage from diabetes (diabetic peripheral neuropathy). Gabapentin is known to cause lower leg swelling. In studies on patients with shingles, swelling appeared in 8% of the patients taking gabapentin.

3) Pregabalin

Pregabalin (Lyrica) may also cause swelling in the feet and legs. Pregablin is similar to gabapentin in that it is prescribed for nerve pain. But it’s also used in patients with spinal cord injury, seizures, or fibromyalgia.

4) NSAIDs

Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Motrin, Advil) and naproxen (Aleve) are popular over-the-counter medications used for pain and inflammation. They are a well-known cause of swelling due to salt retention. In this case, the swelling is typically mild and will go away when you stop taking the medication.

5) Oral contraceptives

The estrogen component of some oral contraceptive pills can cause swelling. But it can be life-threatening or not depending on what’s happening.

Estrogen can increase your risk of a blood clot in the leg (deep vein thrombosis), which can cause one-sided leg swelling. This is an urgent medical issue. However, estrogen can also cause swelling in both legs, which is usually not an emergency.

If you notice swelling and you’re taking a birth control pill, be sure to seek medical attention right away. You may also want to look into a progesterone-only option after your doctor has determined you don’t have deep vein thrombosis.

6) Oral steroids

Oral steroid medications like prednisone are often prescribed for asthma, worsening COPD (chronic obstructive pulmonary disorder), severe allergic reactions, or other autoimmune diseases. Prednisone causes salt retention, which may lead to swelling in the legs and feet.

7) Pioglitazone and rosiglitazone

Pioglitazone (Actos) and rosiglitazone (Avandia) are medications used to treat type 2 diabetes. Leg swelling is a well-known side effect of both meds, so if you experience swelling while taking them, ask your doctor about switching to another medication.

Hope this helps.

– – –

Dr O.

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  • Trintellix (vortioxetine)

    You may wonder how certain drugs compare to Trintellix. Below are comparisons between Trintellix and several other medications.

    Trintellix vs. Viibryd

    Trintellix and Viibryd (vilazodone) are both brand-name prescription antidepressant medications. They each affect serotonin, a chemical messenger in the brain, but they work slightly differently.

    Uses

    Trintellix and Viibryd are both FDA-approved for treating major depressive disorder (MDD) in adults.

    Dosage and forms

    Trintellix and Viibryd both come only as oral tablets. They’re both taken once daily.

    Side effects and risks

    Trintellix and Viibryd share many common and serious side effects.

    More common side effects

    More common side effects shared by Trintellix and Viibryd include:

    • nausea
    • diarrhea
    • dry mouth
    • dizziness
    • trouble sleeping
    • flatulence (gas)
    • vomiting
    • sexual side effects such as erectile dysfunction
    • abnormal dreams

    Serious side effects

    Serious side effects shared by Trintellix and Viibryd include:

    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • serious bleeding
    • low sodium levels

    In an indirect comparison of antidepressants, users were less likely to stop taking Trintellix because of side effects than they were Viibryd.

    Effectiveness

    The effectiveness of Trintellix and Viibryd in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Trintellix and Viibryd work about equally well.

    Cost

    Trintellix and Viibryd are both available only as brand-name drugs. They don’t have generic forms, which are typically less expensive than brand-name versions.

    Trintellix usually costs more than Viibryd. The actual amount you pay will depend on your insurance plan.

    Trintellix vs. Effexor XR

    Trintellix and Effexor XR (venlafaxine) are both prescription antidepressant medications. They both affect serotonin, a chemical messenger in the brain, but Effexor XR also affects norepinephrine.

    Uses

    Trintellix and Effexor XR are both FDA-approved for treating major depressive disorder (MDD) in adults. Effexor XR is also approved for other uses, including:

    • generalized anxiety disorder
    • social anxiety
    • panic attacks

    Dosage and forms

    Trintellix comes only as an oral tablet that’s taken once daily.

    Effexor XR comes as an extended-release capsule that’s taken once daily. A generic immediate-release tablet is also available that’s taken two to three times daily.

    Side effects and risks

    Trintellix and Effexor XR (and generic Effexor) have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Effexor Trintellix Effexor
    More common side effects
    • diarrhea
    • vomiting
    • dry mouth
    • dizziness
    • trouble sleeping
    • sexual side effects
    • constipation
    • abnormal dreams
    • flatulence (gas)
    • itchy skin
    • weakness
    • loss of appetite
    • nervousness
    • sleepiness
    • sweating
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • bleeding
    • low sodium levels
    (few unique serious side effects)
    • increased blood pressure
    • lung infection, such as pneumonia

    In an indirect comparison of antidepressants, users were less likely to stop taking Trintellix because of side effects than Effexor.

    Effectiveness

    The only condition both Trintellix and Effexor XR are used to treat is MDD. The effectiveness of these drugs in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Effexor may be slightly more effective than Trintellix.

    Cost

    Trintellix is only available as a brand-name drug. Effexor XR capsules are available as a brand-name drug and in a generic form called venlafaxine. (Effexor oral tablets are only available in generic form.)

    Effexor XR is similar in price to Trintellix. Generic Effexor XR is typically less expensive than both brand-name products. In any case, the actual amount you pay will depend on your insurance plan.

    Trintellix vs. Wellbutrin

    Trintellix and Wellbutrin (bupropion) are both prescription antidepressant medications. Trintellix mainly affects serotonin, a chemical messenger in the brain. Wellbutrin affects different chemical messengers called norepinephrine and dopamine.

    Uses

    Wellbutrin comes as extended-release tablets called Wellbutrin SR and Wellbutrin XL. Wellbutrin XL is FDA-approved for treating major depressive disorder (MDD) and seasonal affective disorder. Wellbutrin SR is approved only for treating MDD.

    Trintellix is approved only for treating MDD.

    Dosage and forms

    Trintellix comes only as an oral tablet that’s taken once daily. Wellbutrin XL and Wellbutrin SR both come as extended-release tablets that are taken once daily in the morning.

    Side effects and risks

    Trintellix and Wellbutrin XR and Wellbutrin SR have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Wellbutrin (XL and SR) Trintellix Wellbutrin (XL and SR)
    More common side effects
    • nausea
    • diarrhea
    • vomiting
    • dry mouth
    • dizziness
    • trouble sleeping
    • constipation
    • itchy skin
    • flatulence (gas)
    • sexual side effects
    • abnormal dreams
    • headache
    • infection
    • stomach pain
    • weakness
    • chest pain
    • ringing in ears (tinnitus)
    • muscle and joint pain
    • loss of appetite
    • tremor
    • sleepiness
    • sweating
    • sore throat
    • nervousness or anxiety
    • urge to urinate often
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • serious bleeding
    • low sodium levels
    • increased blood pressure
    • seizures
    • symptoms of psychosis, such as hallucinations, confusion, and paranoia

    Effectiveness

    The only condition both Trintellix and Wellbutrin are used to treat is MDD. The effectiveness of these drugs in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Trintellix may be more effective than Wellbutrin.

    Cost

    Trintellix is only available as a brand-name drug. Wellbutrin XL and Wellbutrin SR are available as brand-name drugs as well as in generic forms. Their generic names are bupropion XL and bupropion SR.

    The generic forms of Wellbutrin XL and Wellbutrin SR are much less expensive than Trintellix. But Trintellix is usually less expensive than the brand-name forms of Wellbutrin XL and Wellbutrin SR. In any case, the actual amount you pay will depend on your insurance plan.

    Trintellix vs. Celexa

    Trintellix and Celexa (citalopram) are both prescription antidepressant medications. They both affect serotonin, a chemical messenger in the brain, but they work slightly differently.

    Uses

    Trintellix and Celexa are both FDA-approved for treating major depressive disorder (MDD) in adults.

    Dosage and forms

    Trintellix and Celexa both come only as oral tablets. They’re both taken once daily.

    Side effects and risks

    Trintellix and Celexa have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Celexa Trintellix Celexa
    More common side effects
    • nausea
    • diarrhea
    • vomiting
    • dry mouth
    • trouble sleeping
    • sexual side effects
    • flatulence (gas)
    • abnormal dreams
    • dizziness
    • constipation
    • itchy skin
    • sweating
    • tremor
    • fatigue
    • muscle or joint pain
    • sleepiness
    • loss of appetite
    • anxiety
    • respiratory infection
    • runny nose
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • bleeding
    • low sodium levels
    (few unique serious side effects)
    • abnormal heartbeat

    Effectiveness

    The effectiveness of Trintellix and Celexa in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Trintellix may be slightly more effective than Celexa.

    Cost

    Trintellix comes only as a brand-name drug. Celexa comes as a brand-name drug and in a generic form called citalopram.

    The generic form of Celexa is much less expensive than Trintellix. Also, brand-name Celexa is usually less expensive than Trintellix. In any case, the actual amount you pay will depend on your insurance plan.

    Trintellix vs. Lexapro

    Trintellix and Lexapro (escitalopram) are both prescription antidepressant medications. They both affect serotonin, a chemical messenger in the brain, but they work slightly differently.

    Uses

    Trintellix and Lexapro are both FDA-approved for treating major depressive disorder (MDD) in adults. Lexapro is also approved for treating generalized anxiety disorder.

    Dosage and forms

    Trintellix and Lexapro both come as oral tablets that are taken once daily.

    Side effects and risks

    Trintellix and Lexapro have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Lexapro Trintellix Lexapro
    More common side effects • nausea
    • diarrhea
    • dry mouth
    • trouble sleeping
    • sexual side effects
    • dizziness
    • constipation
    • vomiting
    • flatulence (gas)
    • abnormal dreams
    • itchy skin
    • sweating
    • flu-like symptoms
    • runny nose
    • fatigue
    • sleepiness
    • loss of appetite
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • bleeding
    • low sodium levels
    (few unique serious side effects)
    • seizures

    Effectiveness

    The effectiveness of Trintellix and Lexapro in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Trintellix and Lexapro work about equally well.

    Cost

    Trintellix is only available as a brand-name drug. Lexapro is available as a brand-name drug and in a generic form called escitalopram.

    Generic Lexapro is much less expensive than Trintellix. Brand-name Lexapro is also usually slightly less expensive than Trintellix. In any case, the actual amount you pay will depend on your insurance plan.

    Trintellix vs. Prozac

    Trintellix and Prozac (fluoxetine) are both prescription antidepressant medications. They both affect serotonin, a chemical messenger in the brain, but they work slightly differently.

    Uses

    Trintellix and Prozac are both FDA-approved for treating major depressive disorder (MDD) in adults. Prozac is also approved for treating other conditions, including:

    • obsessive-compulsive disorder (OCD)
    • bulimia (an eating disorder)
    • panic disorder

    Dosage and forms

    Trintellix comes as an oral tablet that’s taken once daily. Prozac comes as an oral pulvule, which is a type of capsule. It’s usually taken once daily in the morning. Prozac also comes as a delayed-release capsule that’s taken once weekly.

    Side effects and risks

    Trintellix and Prozac have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Prozac Trintellix Prozac
    More common side effects
    • diarrhea
    • vomiting
    • dry mouth
    • trouble sleeping
    • sexual side effects
    • dizziness
    • constipation
    • abnormal dreams
    • flatulence (gas)
    • itchy skin
    (few unique common side effects)
    • weakness
    • flu-like symptoms
    • loss of appetite
    • sleepiness
    • tremor
    • sweating
    • rash
    • anxiety
    • nervousness
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • bleeding
    • low sodium levels
    (few unique serious side effects)
    • severe rash
    • seizures
    • weight loss
    • abnormal heartbeat

    Effectiveness

    The only condition both Trintellix and Prozac are approved to treat is MDD. The effectiveness of these drugs in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants showed that Trintellix may be more effective than Prozac.

    Cost

    Trintellix is only available as a brand-name drug. Prozac is available as a brand-name drug and in a generic form called fluoxetine.

    Generic Prozac is much less expensive than Trintellix. But Trintellix is usually less expensive than Prozac. In any case, the actual amount you pay will depend on your insurance plan.

    Trintellix vs. Zoloft

    Trintellix and Zoloft (sertraline) are both prescription antidepressant medications. They both affect serotonin, a chemical messenger in the brain, but they work slightly differently.

    Uses

    Trintellix and Zoloft are both FDA-approved for treating major depressive disorder (MDD) in adults. Zoloft is also approved for treating other conditions, including:

    • obsessive-compulsive disorder (OCD)
    • post-traumatic stress disorder (PTSD)
    • panic disorder
    • social anxiety disorder
    • premenstrual dysphoric disorder

    Dosage and forms

    Trintellix comes as an oral tablet that’s taken once daily. Zoloft comes as an oral tablet and an oral solution. Each form of Zoloft is usually taken once daily in the morning.

    Side effects and risks

    Trintellix and Zoloft have some similar side effects, and some that differ. Below are examples of these side effects.

    Both Trintellix and Zoloft Trintellix Zoloft
    More common side effects
    • nausea
    • diarrhea
    • vomiting
    • dry mouth
    • dizziness
    • trouble sleeping
    • sexual side effects
    • constipation
    • abnormal dreams
    • flatulence (gas)
    • itchy skin
    • blurred vision
    • heart palpitations
    • fatigue
    • loss of appetite
    • sleepiness
    • tremor
    • sweating
    Serious side effects
    • worsening symptoms or suicidal thoughts
    • serotonin syndrome
    • serious bleeding
    • low sodium levels
    (few unique serious side effects)
    • seizures
    • abnormal heartbeat

    Effectiveness

    The only condition both Trintellix and Prozac are approved to treat is MDD. The effectiveness of these drugs in treating MDD hasn’t been directly compared in clinical studies. However, an indirect comparison of antidepressants shows that Trintellix and Zoloft work about equally well.

    Cost

    Trintellix is only available as a brand-name drug. Zoloft is available as a brand-name drug and in a generic form called sertraline.

    The generic form of Zoloft is much less expensive than Trintellix. Brand-name Zoloft is also typically less expensive than Trintellix. In any case, the actual amount you pay will depend on your insurance plan.

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