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Elepsia XR

Last reviewed on RxList: 1/7/2019
Elepsia XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 01/07/2019

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: 

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 Antiepileptic drugs, including Elepsia XR, should be withdrawn gradually to minimize the potential of increased seizure frequency.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.

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow
Elepsia XR Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed below and elsewhere in the labeling:

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)

Body System/
Adverse Reaction
Levetiracetam Extended-Release Tablets
(N=77) %
Placebo
(N=79) %
Gastrointestinal Disorders
Nausea 5 3
Infections and Infestations
Influenza 8 4
Nasopharyngitis 7 5
Nervous System Disorders
Somnolence 8 3
Dizziness 5 3
Psychiatric Disorders
Irritability 7 0

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

Adults

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)

Body System/
Adverse Reaction
Immediate-Release Levetiracetam Tablets
(N=769) %
Placebo
(N=439) %
Body as a Whole
Asthenia 15 9
Headache 14 13
Infection 13 8
Pain 7 6
Digestive System
Anorexia 3 2
Nervous System
Somnolence 15 8
Dizziness 9 4
Depression 4 2
Nervousness 4 2
Ataxia 3 1
Vertigo 3 1
Amnesia 2 1
Anxiety 2 1
Hostility 2 1
Paresthesia 2 1
Emotional Lability 2 0
Respiratory System
Pharyngitis 6 4
Rhinitis 4 3
Cough Increased 2 1
Sinusitis 2 1
Special Senses
Diplopia 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 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)

Body System/
Adverse Reaction
Immediate-Release Levetiracetam Tablets
(N=165) %
Placebo
(N=131) %
Ear and Labyrinth Disorders
Ear Pain 2 1
Eye Disorders
Conjunctivitis 2 0
Gastrointestinal Disorders
Vomiting 15 12
Upper Abdominal Pain 9 8
Diarrhea 6 5
Constipation 3 1
General Disorders and Administration Site Conditions
Fatigue 11 5
Infections and Infestations
Nasopharyngitis 15 12
Influenza 3 1
Gastroenteritis 2 0
Rhinitis 2 0
Injury, Poisoning and Procedural Complications
Head Injury 4 0
Contusion 3 1
Fall 3 2
Joint Sprain 2 1
Metabolism and Nutrition Disorders
Decreased Appetite 8 2
Anorexia 4 3
Musculoskeletal and Connective Tissue Disorders
Arthralgia 2 0
Neck Pain 2 1
Nervous System
Headache 19 15
Somnolence 13 9
Dizziness 7 5
Lethargy 6 2
Sedation 2 1
Psychiatric Disorders
Aggression 10 5
Abnormal Behavior 7 4
Irritability 7 1
Insomnia 5 3
Agitation 4 1
Depression 3 1
Altered Mood 3 1
Affect Lability 2 1
Anxiety 2 1
Confusional State 2 0
Mood Swings 2 1
Respiratory, Thoracic and Mediastinal Disorders
Cough 9 5
Nasal Congestion 9 2
Pharyngolaryngeal Pain 7 4

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)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
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© 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.

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