Keppra Adverse Reactions

Pooled safety data from clinical studies showed that 46.4% and 42.2% of the patients experienced adverse reactions in the Keppra and placebo groups, respectively, and that 2.4% and 2% of the patients experienced serious undesirable effects in the Keppra and placebo groups, respectively. The most commonly reported adverse reactions were somnolence, asthenia and dizziness. In the pooled safety analysis, there was no clear dose-response relationship but incidence and severity of the CNS-related adverse reactions decreased over time.
Undesirable effects reported in clinical studies or from post-marketing experience are listed as follows by system organ class and frequency. For clinical trials, the frequency is defined as follows: Very common (>10%); common (>1-10%); uncommon (>0.1-1%); rare (0.01-0.1%); very rare (<0.01%), including isolated reports. Data from post-marketing experience are insufficient to support an estimate of their incidence in the population to be treated.
General Disorders and Administration Site Conditions: Very Common: Asthenia.
Nervous System Disorders: Very Common: Somnolence. Common: Amnesia, ataxia, convulsion, dizziness, headache, tremor.
Psychiatric Disorders: Common: Depression, emotional lability, hostility, insomnia, nervousness. Post-Marketing Experience: Abnormal behaviour, aggression, anger, anxiety, confusion, hallucination, irritability, psychotic disorder.
Gastrointestinal Disorders: Common: Diarrhoea, dyspepsia, nausea.
Metabolism and Nutrition Disorders: Common: Anorexia.
Ear and Labyrinth Disorders: Common: Vertigo.
Eye Disorders: Common: Diplopia.
Injury, Poisoning and Procedural Complications: Common: Accidental injury.
Skin and Subcutaneous Tissue Disorders: Common: Rash.
Blood and Lymphatic System Disorders: Post-Marketing Experience: Leukopenia, neutropenia, pancytopenia, thrombocytopenia.