Causality assessment · Expected pharmacological effect

Brivaracetam and Aggression: is the FAERS signal real?

n=297 co-reports · PRR 14.0 · ROR 14.4

Brivaracetam side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Brivaracetam ↔ Aggression

n=297 co-reports · PRR 14.0 · ROR 14.4

Brivaracetam is a second-generation synaptic-vesicle-protein-2A ligand for epilepsy; aggression and irritability are recognised psychiatric effects and appear here as 297 co-reports (PRR 14.0). The reactions are typically early and can be dose-related, so the label advises monitoring for mood and behavioural changes, particularly in patients with a psychiatric history.

Regulatory basis: brivaracetam (Briviact) prescribing information — psychiatric reactions including aggression and irritability.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Behaviour change within weeks
Strength	met	PRR 14.0, large
Consistency	met	Reproduced across trials
Specificity	met	Fairly specific to brivaracetam
Biological gradient	met	Dose-related
Plausibility	met	SV2A-mediated CNS effect
Coherence	met	Fits the pharmacology
Experiment	met	Trials recorded psychiatric events
Analogy	met	Analogous to other AED behavioural effects

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy (NCT00175916)

Adverse event	Brivaracetam (SS) (n=853)
Aggression	3/853

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →