Roweepra XR Side Effects

Generic name: levetiracetam

Medically reviewed by Drugs.com. Last updated on Apr 27, 2024.

Note: This document provides detailed information about Roweepra XR Side Effects associated with levetiracetam. Some dosage forms listed on this page may not apply specifically to the brand name Roweepra XR.

Applies to levetiracetam: oral solution, oral tablet, oral tablet for suspension, oral tablet extended release.

Other dosage forms:

• intravenous solution

Precautions

It is very important that your doctor check your or your child's progress at regular visits, especially for the first few months you or your child are using this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

It is important to tell your doctor if you become pregnant while using this medicine. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

Levetiracetam may cause changes in mood or behavior, problems with coordination, or unusual tiredness or weakness. Tell your doctor right away if you or your child start to feel depressed, anxious, angry, getting upset easily, restless, or have thoughts about hurting yourself. Report any unusual thoughts or behavior that trouble you, especially if they are new or getting worse quickly.

This medicine may cause some people to become dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause serious allergic reactions, including anaphylaxis or angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

Do not stop using levetiracetam (the active ingredient contained in Roweepra XR) without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Serious side effects of Roweepra XR

Along with its needed effects, levetiracetam 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 levetiracetam:

Other side effects of Roweepra XR

Some side effects of levetiracetam 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:

For healthcare professionals

Applies to levetiracetam: intravenous solution, oral solution, oral tablet, oral tablet dispersible, oral tablet extended release.

General adverse events

The more commonly reported adverse reactions in adults have included somnolence, asthenia, and dizziness; in children, fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Nervous system

• Very common (10% or more): Headache (14%), somnolence (14%)
• Common (1% to 10%): Dizziness, ataxia, vertigo, paresthesia, coordination difficulties
• Postmarketing reports: Choreoathetosis, dyskinesia^[Ref]

Psychiatric

• Very common (10% or more): Non-psychotic behavioral symptoms (up to 38%), psychotic symptoms (up to 17%)
• Common (1% to 10%): Depression, nervousness, amnesia, anxiety, hostility, emotional lability, irritability, mood swings, hypersomnia, insomnia, apathy, tearfulness, negativism
• Postmarketing reports: Panic attack^[Ref]

In studies, non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder) were reported in 13% of adults and 38% of pediatric patients aged 4 to 16 years compared to 6% and 19%, respectively in placebo patients. In patients less than 4 years old, irritability was reported in 12% compared to 0% in placebo patients. In adult patients, behavioral symptoms resulted in dose reduction or discontinuation 0.8% and 1.7% of patients, respectively. Dose reduction or discontinuation due to behavioral symptoms occurred in 11% of pediatric patients.

In studies, psychotic symptoms were reported in 1%, 2%, and 17% of patients receiving this drug aged adult, 4 to 16 years old, and less than 4 years compared to 0.2%, 2%, and 5% in placebo patients, respectively.^[Ref]

Hematologic

• Common (1% to 10%): Decreased white blood cell count (WBC), decreased neutrophil count, increased lymphocyte counts, higher eosinophil counts
• Frequency not reported: Decreases in white blood cell, neutrophil, and red blood cell counts; decreased in hemoglobin and hematocrit; increases in eosinophil counts
• Postmarketing reports: Pancytopenia (with bone marrow suppression reported in some cases), thrombocytopenia, agranulocytosis^[Ref]

In adults, 3.2% of patients receiving this drug had at least 1 WBC of 2.8 x 10(9)/L or lower and 2.4% had at least 1 neutrophil count of 1 x 10(9)/L or lower compared to 1.8% and 1.4% of placebo patients, respectively. Of those with a low neutrophil count, only 1 patient did not have resolution with continued treatment. No patient discontinued therapy due to a low neutrophil count. In pediatric patients 4 to 16 years old, mean decreases in WBC and neutrophils were 0.4 x 10(9)/L and 0.3 x 10(9)/L, respectively, compared to small increases in placebo patients. Mean relative lymphocyte counts increased by 1.7% in patients receiving this drug (placebo=decrease of 4%).^[Ref]

Hypersensitivity

• Postmarketing reports: Anaphylaxis

Dermatologic

• Frequency not reported: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
• Postmarketing reports: Erythema multiforme, alopecia, angioedema^[Ref]

Alopecia reported with this drug resolved with discontinuation of therapy in most cases.^[Ref]

Other

• Very common (10% or more): Asthenia (15%), fatigue (10%)
• Common (1% to 10%): Pain, vertigo^[Ref]

Respiratory

• Common (1% to 10%): Pharyngitis, rhinitis, increased cough, sinusitis^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, gastroenteritis, constipation
• Uncommon (0.1% to 1%): Nausea
• Postmarketing reports: Pancreatitis^[Ref]

Ocular

• Common (1% to 10%): Diplopia^[Ref]

Hepatic

• Postmarketing reports: Abnormal liver function tests, hepatic failure, hepatitis^[Ref]

Musculoskeletal

• Common (1% to 10%): Neck pain
• Postmarketing reports: Muscular weakness^[Ref]

Immunologic

• Very common (10% or more): Infection (13%)
• Common (1% to 10%): Influenza
• Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Postmarketing reports: Weight loss, hyponatremia^[Ref]

Cardiovascular

• Very common (10% or more): Increased diastolic blood pressure (less than 4 years of age; 17%)^[Ref]

In a clinical trial in patients 1 month to less than 4 years, 17% of patients had a significantly elevated diastolic blood pressure (placebo=2%). No overall difference in mean diastolic blood pressure was observed in treated patients compared with placebo nor was this effect observed in trials with older pediatric patients or adults.^[Ref]

Renal

• Postmarketing reports: Acute kidney injury

See also:

Further information

Roweepra XR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer