Intiracetam Adverse Reactions

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 as follows by MedDRA system organ class and by frequency.
Frequencies are defined as: Very common, Common, Uncommon, Rare, Very rare, 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: neutropenia, pancytopenia, 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.
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.
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, nausea, vomiting.
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 coadministered 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.
Cases of encephalopathy have been rarely observed after levetiracetam administration. These undesirable effects generally occurred at the beginning of the treatment (few days to a few months) and were reversible after treatment discontinuation.
Paediatric population: The adverse event profile of levetiracetam is generally similar across age groups and across the approved epilepsy indications. Safety results in paediatric patients were consistent with the safety profile of levetiracetam in adults except for behavioural and psychiatric adverse reactions which were more common in children than in adults. In children and adolescents aged 4 to 16 years, vomiting (very common), agitation (common), mood swings (common), affect lability (common), aggression (common), abnormal behaviour (common), and lethargy (common) were reported more frequently than in other age ranges or in the overall safety profile. In infants and children aged 1 month to less than 4 years, irritability (very common) and coordination abnormal (common) were reported more frequently than in other age groups or in the overall safety profile.