Keppra Adverse Reactions

Clinical Trial Data and Post-marketing Data: Summary of the safety profile: The adverse event profile presented as follows is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam. These data are supplemented with the use of levetiracetam in corresponding open-label extension studies, as well as post-marketing experience. The most frequently reported adverse reactions were nasopharyngitis, somnolence, headache, fatigue and dizziness. The safety profile of levetiracetam is generally similar across age groups (adult and paediatric patients) and across the approved epilepsy indications.
Adverse drug reactions (ADRs) are listed by MedDRA system organ class and by frequency. Frequencies are defined as: Very common ≥1/10; Common ≥1/100 to <1/10; Uncommon ≥1/1,000 to <1/100; Rare ≥1/10,000 to <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).
Infections and infestations: Very common: nasopharyngitis. Rare: infection
Blood and lymphatic system disorders: Uncommon: thrombocytopenia, leukopenia. Rare: pancytopenia, neutropenia, agranulocytosis
Immune system disorders: Rare: drug reaction with eosinophilia and systemic symptoms (DRESS), hypersensitivity (including angioedema and anaphylaxis)
Metabolism and nutrition disorders: Common: anorexia. Uncommon: weight decreased, weight increase. Rare: hyponatraemia
Psychiatric disorders: Common: depression, hostility/aggression, anxiety, insomnia, nervousness/irritability. Uncommon: suicide attempt, suicidal ideation, psychotic disorder, abnormal behaviour, hallucination, anger, confusional state, panic attack, affect lability/mood swings, agitation. Rare: completed suicide, personality disorder, thinking abnormal, delirium
Nervous system disorders: Very common: somnolence, headache. Common: convulsion, balance disorder, dizziness, lethargy, tremor. Uncommon: amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia, disturbance in attention. Rare: choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy, seizures aggravated
Eye disorders: Uncommon: diplopia, vision blurred
Ear and labyrinth disorders: Common: vertigo
Cardiac disorders: Rare: electrocardiogram QT prolonged
Respiratory, thoracic and mediastinal disorders: Common: cough
Gastrointestinal disorders: Common: abdominal pain, diarrhoea, dyspepsia, vomiting, nausea. Rare: pancreatitis
Hepatobiliary disorders: Uncommon: liver function test abnormal. Rare: hepatic failure, hepatitis
Renal and urinary disorders: Rare: acute kidney injury
Skin and subcutaneous tissue disorders: Common: rash. Uncommon: alopecia, eczema, pruritus. Rare: toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme
Musculoskeletal and connective tissue disorders: Uncommon: muscular weakness, myalgia. Rare: rhabdomyolysis and blood creatine phosphokinase increased*
General disorders and administration site conditions: Common: asthenia/fatigue
Injury, poisoning and procedural complications: Uncommon: injury
* Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients.
Description of selected adverse reactions: The risk of anorexia is higher when levetiracetam is co-administered with topiramate.
In several cases of alopecia, recovery was observed when levetiracetam was discontinued.
Bone marrow suppression was identified in some of the cases of pancytopenia.
Case of encephalopathy generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.