Medical Editor: John P. Cunha, DO, FACOEP
Elepsia XR (levetiracetam) Extended-release is an antiepileptic drug indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥ 12 years of age with epilepsy. Common side effects of Elepsia XR include:
- runny or stuffy nose,
- sore throat,
- loss of appetite,
- loss of balance and coordination,
- numbness and tingling,
- mood changes,
- sinus infection, and
- double vision.
The starting dose of Elepsia XR is 1,000 mg once daily. The once daily dosage may be adjusted in increments of 1,000 mg every 2 weeks to a maximum recommended once daily dose of 3,000 mg. Elepsia XR may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Elepsia XR should be used only if prescribed; it is unknown if it could affect a fetus. Tell your doctor if you become pregnant or intend to become pregnant while taking Elepsia XR. Patients are encouraged to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. Elepsia XR passes into breast milk. Breastfeeding while taking Elepsia XR is not recommended. Antiepileptic drugs, including Elepsia XR, should be withdrawn gradually to minimize the potential of increased seizure frequency.
Our Elepsia 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.
The following serious adverse reactions are discussed below and elsewhere in the labeling:
- Psychiatric Reactions [see WARNINGS AND PRECAUTIONS]
- Suicidal Behavior And Ideation [see WARNINGS AND PRECAUTIONS]
- Somnolence And Fatigue [see WARNINGS AND PRECAUTIONS]
- Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
- Coordination Difficulties [see WARNINGS AND PRECAUTIONS]
- Withdrawal Seizures [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.
The prescriber should be aware that the adverse reaction incidence figures in the following table, obtained when levetiracetam extended-release tablets were added to concurrent AED therapy, cannot be used to predict the frequency of adverse reactions in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical trials. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied.
Levetiracetam Extended-Release Tablets
In the controlled clinical study using levetiracetam extended-release tablets in patients with partial onset seizures (Study 1), the most frequently reported 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 treated with levetiracetam extended-release tablets participating in the placebo-controlled study (Study 1) 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: Incidence (%) Of Adverse Reactions In The
Placebo-Controlled, Add-On Study By Body System (Adverse Reactions Occurred In
At Least 5% Of Levetiracetam Extended-Release Tablets-Treated Patients And
Occurred More Frequently Than Placebo-Treated Patients)
|Levetiracetam Extended-Release Tablets
|Infections and Infestations|
|Nervous System Disorders|
Discontinuation or Dose Reduction in the Levetiracetam Extended-Release Tablets Controlled Clinical Study
In the controlled clinical study using levetiracetam extended-release tablets, 5.2% of patients receiving levetiracetam extended-release tablets and 2.5% 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.
Table 4 lists the adverse reactions seen 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.
Immediate-Release Levetiracetam Tablets
In controlled clinical studies of immediate-release levetiracetam tablets as adjunctive therapy to other AEDs in adults with partial onset seizures, the most frequently reported 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 treated with immediate-release levetiracetam tablets participating 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: Incidence (%) Of
Adverse Reactions In Placebo-Controlled, Add-On Studies In Adults Experiencing
Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least
1% Of Immediate-Release Levetiracetam Tablets-Treated Patients And Occurred
More Frequently Than Placebo-Treated Patients)
|Immediate-Release Levetiracetam Tablets
|Body as a Whole|
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 tablets 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 immediate-release levetiracetam tablets and were more common than in pediatric patients on placebo. In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy.
Table 5: Incidence (%) Of
Adverse Reactions In Pooled Placebo-Controlled, Add-On Studies In Pediatric
Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures By Body System
(Adverse Reactions Occurred In At Least 2% Of Patients Treated With
Immediate-Release Levetiracetam Tablets And Occurred More Frequently Than
Patients on Placebo)
|Immediate-Release Levetiracetam Tablets
|Ear and Labyrinth Disorders|
|Upper Abdominal Pain||9||8|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Injury, Poisoning and Procedural Complications|
|Metabolism and Nutrition Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Respiratory, Thoracic and Mediastinal Disorders|
In controlled pediatric clinical studies in patients 4 to 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 well-controlled studies of immediate-release levetiracetam tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and vision blurred.
Comparison of Gender, Age and Race
There are insufficient data for levetiracetam extended-release tablets to support a statement regarding the distribution of adverse experience reports by gender, age and race.
Read the entire FDA prescribing information for Elepsia XR (Levetiracetam Extended-release Tablets)
© Elepsia XR Patient Information is supplied by Cerner Multum, Inc. and Elepsia XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.