Keppra Side Effects

Generic Name: Levetiracetam

Please note - some side effects for Keppra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Keppra - for the consumer

Keppra

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra:

Dizziness; drowsiness; loss of appetite; runny nose; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; apathy; irritability); changes in vision; decreased coordination; depression; fever, chills, or sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; yellowing of the skin or eyes.

Keppra Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Keppra Solution:

Dizziness; drowsiness; loss of appetite; runny nose; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavioral changes (eg, aggression; agitation; anger; apathy; irritability); changes in vision; decreased coordination; depression; fever, chills, or sore throat; hallucinations; memory loss; mental or mood changes; new or worsening seizures; suicidal thoughts or attempts; unusual bruising or bleeding; yellowing of the skin or eyes.

For the professional

Keppra

The prescriber should be aware that the adverse event incidence figures in the following tables, obtained when Keppra was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. 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 event incidences in the population studied.

Partial Onset Seizures

In well-controlled clinical studies in adults with partial onset seizures, the most frequently reported adverse events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness. In the well-controlled pediatric clinical study in children 4 to 16 years of age with partial onset seizures, the adverse events most frequently reported with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, accidental injury, hostility, nervousness, and asthenia.

Table 7 lists treatment-emergent adverse events that occurred in at least 1% of adult epilepsy patients treated with Keppra participating in placebo-controlled studies and were numerically more common than in patients treated with placebo. Table 8 lists treatment-emergent adverse events that occurred in at least 2% of pediatric epilepsy patients (ages 4-16 years) treated with Keppra participating in the placebo-controlled study and were numerically more common than in pediatric patients treated with placebo. In these studies, either Keppra or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.

Other events reported by at least 1% of adult Keppra-treated patients but as or more frequent in the placebo group were the following: abdominal pain, accidental injury, amblyopia, arthralgia, back pain, bronchitis, chest pain, confusion, constipation, convulsion, diarrhea, drug level increased, dyspepsia, ecchymosis, fever, flu syndrome, fungal infection, gastroenteritis, gingivitis, grand mal convulsion, insomnia, nausea, otitis media, rash, thinking abnormal, tremor, urinary tract infection, vomiting and weight gain.

Other events occurring in at least 2% of pediatric Keppra-treated patients but as or more frequent in the placebo group were the following: abdominal pain, allergic reaction, ataxia, convulsion, epistaxis, fever, headache, hyperkinesia, infection, insomnia, nausea, otitis media, rash, sinusitis, status epilepticus (not otherwise specified), thinking abnormal, tremor, and urinary incontinence.

Myoclonic Seizures

Although the pattern of adverse events in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse event pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.

In the well-controlled clinical study that included both adolescent (12 to 16 years of age) and adult patients with myoclonic seizures, the most frequently reported adverse events associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis.

Table 9 lists treatment-emergent adverse events that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with Keppra and were numerically more common than in patients treated with placebo. In this study, either Keppra or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.

Other events occurring in at least 5% of Keppra-treated patients with myoclonic seizures but as or more frequent in the placebo group were the following: fatigue and headache.

Primary Generalized Tonic-Clonic Seizures

Although the pattern of adverse events in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse event pattern for patients with PGTC seizures is expected to be essentially the same as for patients with partial seizures.

In the well-controlled clinical study that included patients 4 years of age and older with primary generalized tonic-clonic (PGTC) seizures, the most frequently reported adverse event associated with the use of Keppra in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, was nasopharyngitis.

Table 10 lists treatment-emergent adverse events that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with Keppra and were numerically more common than in patients treated with placebo. In this study, either Keppra or placebo was added to concurrent AED therapy. Adverse events were usually mild to moderate in intensity.

Other events occurring in at least 5% of Keppra-treated patients with PGTC seizures but as or more frequent in the placebo group were the following: dizziness, headache, influenza, and somnolence.

Time Course Of Onset Of Adverse Events For Partial Onset Seizures

Of the most frequently reported adverse events in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with Keppra.

Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies

In well-controlled adult clinical studies, 15.0% of patients receiving Keppra and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 11 lists the most common (>1%) adverse events that resulted in discontinuation or dose reduction.

In the well-controlled pediatric clinical study, 16.8% of patients receiving Keppra and 20.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events most commonly associated (≥3% in patients receiving Keppra) with discontinuation or dose reduction in the well-controlled study are presented in Table 12.

In the placebo-controlled study, 8.3% of patients receiving Keppra and 1.7% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse events that led to discontinuation or dose reduction in the well-controlled study are presented in Table 13.

In the placebo-controlled study, 5.1% of patients receiving Keppra and 8.3% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of a treatment-emergent adverse event.

This study was too small to adequately characterize the adverse events leading to discontinuation. It is expected that the adverse events that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials.

Comparison Of Gender, Age And Race

The overall adverse experience profile of Keppra was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse experience reports by age and race.

Postmarketing Experience

In addition to the adverse experiences listed above, the following have been reported in patients receiving marketed Keppra worldwide. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia, and weight loss. Alopecia has been reported with Keppra use; recovery was observed in majority of cases where Keppra was discontinued. There have been reports of suicidal behavior (including completed suicide) with marketed Keppra. These adverse experiences have not been listed above, and data are insufficient to support an estimate of their incidence or to establish causation.

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