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Roweepra XR

Last reviewed on RxList: 10/15/2019
Roweepra XR Side Effects Center

Last reviewed on RxList 10/15/2019

Roweepra XR (levetiracetam) Extended-Release is an antiepileptic drug (AED) indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. Roweepra XR is available in generic form. Common side effects of Roweepra XR include:

The starting dose Roweepra XR is 1,000 mg once daily. The once daily dosage of Roweepra XR may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended daily dose of 3,000 mg/day. Roweepra XR may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Roweepra XR; it may harm a fetus. Roweepra XR passes into breast milk. Because of the potential for adverse reactions in nursing infants, breastfeeding while using Roweepra XR is not recommended. Withdrawal seizures may occur if you suddenly stop taking Roweepra XR.

Our Roweepra XR (levetiracetam) Extended-Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Roweepra XR Professional Information

SIDE EFFECTS

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

  • Behavioral abnormalities and Psychotic Symptoms [ see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior And Ideation [ see WARNINGS AND PRECAUTIONS]
  • Somnolence And Fatigue [ see WARNINGS AND PRECAUTIONS]
  • Anaphylaxis and Angioedema [see WARNINGS AND PRECAUTIONS]
  • Serious Dermatological Reactions [ see WARNINGS AND PRECAUTIONS]
  • Coordination Difficulties [ see WARNINGS AND PRECAUTIONS]
  • Hematologic Abnormalities [ see WARNINGS AND PRECAUTIONS]

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.

Levetiracetam Extended-release Tablets

In the controlled clinical study in patients with partial onset seizures, the most common adverse reactions in patients receiving Levetiracetam Extended-release Tablets in combination with other AEDs, for events with rates greater than placebo, were irritability and somnolence.

Table 3 lists adverse reactions that occurred in at least 5% of epilepsy patients receiving Levetiracetam Extended-release Tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either Levetiracetam Extended-release Tablets or placebo was added to concurrent AED therapy.

Table 3: Adverse Reactions in the Placebo-Controlled, Add-On Study in Patients Experiencing Partial Onset Seizures

  Levetiracetam Extended-release Tablets
(N=77) %
Placebo
(N=79) %
Influenza 8 4
Somnolence 8 3
Irritability 7 0
Nasopharyngitis 7 5
Dizziness 5 3
Nausea 5 3

Discontinuation Or Dose Reduction In The Levetiracetam Extended-release Tablets Controlled Clinical Study

In the controlled clinical study, 5% of patients receiving Levetiracetam Extended-release Tablets and 3% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions that resulted in discontinuation and that occurred more frequently in Levetiracetam Extended-release Tablets-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash and respiratory failure. Each of these adverse reactions led to discontinuation in a Levetiracetam Extended-release Tablets-treated patient and no placebo-treated patients.

Immediate-Release Levetiracetam Tablets

Table 4 lists the adverse reactions in the controlled studies of immediate-release levetiracetam tablets in adult patients experiencing partial onset seizures. Although the pattern of adverse reactions in the Levetiracetam Extended-release Tablets study seems somewhat different from that seen in partial onset seizure controlled studies for immediate-release Levetiracetam tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for Levetiracetam Extended-release Tablets are expected to be similar to those seen with immediate-release Levetiracetam tablets.

Adults

In controlled clinical studies of immediate-release Levetiracetam tablets as adjunctive therapy to other AEDs in adults with partial onset seizures, the most common adverse reactions, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness.

Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving immediate-release Levetiracetam tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release Levetiracetam tablets or placebo was added to concurrent AED therapy.

Table 4: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Adults Experiencing Partial Onset Seizures

  Levetiracetam
(N=769) %
Placebo
(N=439) %
Asthenia 15 9
Somnolence 15 8
Headache 14 13
Infection 13 8
Dizziness 9 4
Pain 7 6
Pharyngitis 6 4
Depression 4 2
Nervousness 4 2
Rhinitis 4 3
Anorexia 3 2
Ataxia 3 1
Vertigo 3 1
Amnesia 2 1
Anxiety 2 1
Cough Increased 2 1
Diplopia 2 1
Emotional Lability 2
Hostility 2 1
Paresthesia 2 1
Sinusitis 2 1

Pediatric Patients 4 Years To <16 Years

In a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial onset seizures, the adverse reactions most frequently reported with the use of immediate-release Levetiracetam in combination with other AEDs, and with greater frequency than in patients on placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions that occurred in at least 2% of pediatric patients treated with immediaterelease Levetiracetam and were more common than in pediatric patients on placebo. In these studies, either immediate-release Levetiracetam or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 5: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures

  Levetiracetam
(N=165) %
Placebo
(N=131) %
Headache 19 15
Nasopharyngitis 15 12
Vomiting 15 12
Somnolence 13 9
Fatigue 11 5
Aggression 10 5
Abdominal Pain Upper 9 8
Cough 9 5
Nasal Congestion 9 2
Decreased Appetite 8 2
Abnormal Behavior 7 4
Dizziness 7 5
Irritability 7 1
Pharyngolaryngeal Pain 7 4
Diarrhea 6 2
Lethargy 6 5
Insomnia 5 3
Agitation 4 1
Anorexia 4 3
Head Injury 4 0
Constipation 3 1
Contusion 3 1
Depression 3 1
Fall 3 2
Influenza 3 1
Mood Altered 3 1
Affect Lability 2 1
Anxiety 2 1
Arthralgia 2 0
Confusional State 2 0
Conjunctivitis 2 0
Ear Pain 2 1
Gastroenteritis 2 0
Joint Sprain 2 1
Mood Swings 2 1
Neck Pain 2 1
Rhinitis 2 0
Sedation 2 1

In controlled pediatric clinical studies in patients 4-16 years of age, 7% of patients treated with immediate-release Levetiracetam tablets and 9% of patients on placebo discontinued as a result of an adverse event.

In addition, the following adverse reactions were seen in other controlled studies of immediate-release Levetiracetam tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and blurred vision.

Comparison Of Gender, Age And Race

There are insufficient data for Levetiracetam Extended-release Tablets to support a statement regarding the distribution of adverse reactions by gender, age and race.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of immediate-release Levetiracetam tablets. 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.

The listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylasix, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, and weight loss. Alopecia has been reported with immediate-release Levetiracetam use; recovery was observed in majority of cases where immediate-release Levetiracetam was discontinued.

Read the entire FDA prescribing information for Roweepra XR (Levetiracetam Extended-release Tablets)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
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© Roweepra XR Patient Information is supplied by Cerner Multum, Inc. and Roweepra XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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