Causality assessment · Expected pharmacological effect

Perampanel and Aggression: is the FAERS signal real?

n=499 co-reports · PRR 28.0 · ROR 29.9

Perampanel 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

Perampanel ↔ Aggression

n=499 co-reports · PRR 28.0 · ROR 29.9

Perampanel is a non-competitive AMPA-receptor antagonist for focal epilepsy; aggression, irritability, and hostility are labelled psychiatric effects and appear here as 499 co-reports (PRR 28.0). The reactions cluster in the first weeks of treatment and are dose-related, so the label advises slow titration and monitoring for behavioural change, especially in patients with a psychiatric history.

Regulatory basis: perampanel (Fycompa) prescribing information — aggression, hostility, and irritability warnings; titration guidance.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Behaviour change within weeks
Strength	met	PRR 28.0, large
Consistency	met	Reproduced across trials
Specificity	met	Fairly specific to perampanel
Biological gradient	met	Dose-related
Plausibility	met	AMPA-receptor blockade in limbic circuits
Coherence	met	Fits the pharmacology
Experiment	met	Trials recorded aggression
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 — A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures (NCT01618695)

Adverse event	Core Phase: Placebo (n=176) · Core Phase: Perampanel 4 mg (n=176) · Core Phase: Perampanel 8 mg (n=175) · Core Phase: Perampanel 12 mg (n=180)
Aggression	0/176	0/176	0/175	2/180

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 →