Causality assessment · Causality: well established

Rufinamide and Convulsion: is the FAERS signal real?

n=76 co-reports · PRR 10.7 · ROR 11.0

Rufinamide 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.

Causality: well established

Rufinamide ↔ Convulsion

n=76 co-reports · PRR 10.7 · ROR 11.0

Rufinamide is an antiepileptic used mainly for Lennox-Gastaut syndrome; convulsion/seizure worsening appears here at 76 co-reports (PRR 10.7). All antiepileptics can paradoxically exacerbate seizures, and rufinamide also shortens the QT interval (a distinctive, labelled effect); the drug must be withdrawn slowly because abrupt cessation can provoke status epilepticus.

Regulatory basis: rufinamide (Banzel) prescribing information — seizure worsening; QT-shortening effect; withdrawal advice.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Seizure worsening during titration
Strength	met	PRR 10.7, large
Consistency	met	Reported across antiepileptics
Specificity	not established	Not specific to rufinamide
Biological gradient	met	More likely with rapid titration
Plausibility	met	Altered neuronal excitability
Coherence	met	Fits the antiepileptic picture
Experiment	met	Trial data support it
Analogy	met	Analogous to other antiepileptics

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 — Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures (NCT00334958)

Adverse event	Rufinamide (n=176) · Placebo (n=180)
Convulsion	2/176	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 →