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Safety Profile

Side Effects

A comprehensive, evidence-based review of levetiracetam's adverse effect profile — neuropsychiatric, cognitive, and systemic.

Printable quick guide

FDA Safety Communication (2023)

The FDA has warned of a rare but serious drug reaction — Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) — associated with levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam. DRESS can be fatal and may begin as a rash but can rapidly progress to involve internal organs. All antiepileptic drugs also carry a class warning for suicidal thoughts and behaviours.

Neuropsychiatric Effects

These are the most clinically significant adverse effects of levetiracetam. They are often under-recognised and under-reported. Expand each item for mechanism and citations.

Cognitive Effects

Memory impairment

Difficulties with verbal and working memory have been reported in observational studies, though the effect is generally smaller than with older AEDs.

Attention & concentration

Reduced sustained attention and processing speed, particularly at higher doses.

Psychomotor slowing

Slowed reaction times and reduced cognitive processing speed, which may affect driving and occupational performance.

Systemic Effects

Fatigue & somnolence

Among the most common adverse effects; reported in up to 15% of patients in clinical trials.

Dizziness

Reported in approximately 9% of patients; may contribute to falls risk in elderly patients.

Infection risk

Nasopharyngitis and other infections reported at higher rates than placebo in clinical trials.

DRESS (rare but serious)

Drug Reaction with Eosinophilia and Systemic Symptoms — a rare but potentially fatal hypersensitivity reaction. FDA issued a safety communication in 2023.

Risk Factors for Neuropsychiatric Adverse Effects

Prior psychiatric history
High dose or rapid titration
Paediatric or elderly patients
Concurrent psychotropic medications

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Medical Disclaimer: This website is for informational and educational purposes only. It does not constitute medical advice and should not replace consultation with a qualified healthcare professional. Always discuss treatment decisions with your doctor.