Rufinamide side effects: what 2,575 FDA adverse event reports show

Rufinamide · 62 reaction terms · 2,439 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

2,575 reports · 71% serious · 151 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablet is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )

FDA label, Indications and Usage

What it is

Rufinamide tablet USP is a triazole derivative structurally unrelated to currently marketed antiepileptic drugs (AEDs). Rufinamide USP has the chemical name 1-[(2,6-difluorophenyl)methyl]-1 H -1,2,3-triazole-4 carboxamide. It has an empirical formula of C 10 H 8 F 2 N 4 O and a molecular weight of 238.2.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 9Likely indication confounding 2Reporting / coding artifact 9Not in label — unassessed 20

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 22 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Status epilepticus	64	46.3 36.3–59.0ROR 47.5 · χ² 2,778 / p <1e-300	45.5 EB05 36.9 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 37.2	no trial data cached
Seizure	647	46.2 43.2–49.4ROR 61.3 · χ² 28,537 / p <1e-300	45.8 EB05 43.0 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.2	no trial data cached
Generalised tonic-clonic seizure	87	43.5 35.4–53.5ROR 45.0 · χ² 3,556 / p <1e-300	42.9 EB05 35.9 · IC025 +4.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 30.9	no trial data cached
Drug resistance	77	24.5 19.6–30.5ROR 25.2 · χ² 1,708 / p <1e-300	24.3 EB05 20.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 20.7 · ♀ 86% (drug 48%) · 100% clinician	no trial data cached
Ataxia	33	22.6 16.1–31.7ROR 22.9 · χ² 659 / p 1e-145	22.3 EB05 16.6 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.5	no trial data cached
Epilepsy	83	22.2 18.0–27.4ROR 22.9 · χ² 1,658 / p <1e-300	22.1 EB05 18.3 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.8 · 90% clinician	no trial data cached
Motor dysfunction	17	13.7 8.5–22.0ROR 13.8 · χ² 187 / p 6e-43	12.8 EB05 7.9 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.1	no trial data cached
Mitral valve incompetence	18	13.0 8.2–20.6ROR 13.1 · χ² 187 / p 8e-43	12.1 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Aggression	76	12.4 9.9–15.4ROR 12.7 · χ² 783 / p 2e-172	12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · ♀ 19% (drug 48%)	no trial data cached
Pneumonia aspiration	37	12.1 8.8–16.7ROR 12.3 · χ² 366 / p 8e-82	11.7 EB05 8.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.5	no trial data cached
Salivary hypersecretion	14	11.4 6.8–19.3ROR 11.5 · χ² 123 / p 8e-29	10.0 EB05 5.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Drug level decreased	14	11.2 6.6–18.8ROR 11.2 · χ² 119 / p 4e-28	9.7 EB05 5.6 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 8.7	no trial data cached
Convulsion (seizure)	76	10.7 8.6–13.3ROR 11.0 · χ² 658 / p 2e-145	10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5	no trial data cached
Myoclonus	15	10.3 6.2–17.0ROR 10.3 · χ² 116 / p 2e-27	8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Sedation	31	9.7 6.8–13.8ROR 9.8 · χ² 233 / p 6e-53	9.0 EB05 6.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Prescribed overdose	20	8.4 5.4–13.0ROR 8.5 · χ² 123 / p 5e-29	7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Therapy non-responder	46	8.4 6.3–11.2ROR 8.5 · χ² 293 / p 5e-66	7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.1 · 91% clinician	no trial data cached
Abnormal behaviour	40	8.2 6.0–11.1ROR 8.3 · χ² 245 / p 2e-55	7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Drug level increased	16	7.9 4.8–12.8ROR 7.9 · χ² 89 / p 2e-21	6.7 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.0	no trial data cached
Lethargy	53	7.5 5.8–9.8ROR 7.6 · χ² 293 / p 5e-66	7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Somnolence (drowsiness)	181	7.3 6.4–8.4ROR 7.8 · χ² 993 / p 3e-218	7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial data cached
Cognitive disorder	39	6.8 5.0–9.3ROR 6.9 · χ² 189 / p 3e-43	6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Hypersomnia	24	6.8 4.6–10.2ROR 6.9 · χ² 114 / p 7e-27	6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3	no trial data cached
Incorrect route of product administration	13	6.3 3.7–10.8ROR 6.3 · χ² 53 / p 2e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.5	no trial data cached
Coordination abnormal	10	5.8 3.1–10.8ROR 5.8 · χ² 35 / p 2e-9	4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2	no trial data cached
Treatment failure	58	5.8 4.5–7.4ROR 5.9 · χ² 224 / p 6e-51	5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · ♀ 19% (drug 48%)	no trial data cached
Irritability	42	5.7 4.2–7.7ROR 5.8 · χ² 158 / p 2e-36	5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Anger	23	5.5 3.7–8.3ROR 5.6 · χ² 81 / p 1e-19	5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Encephalopathy	16	5.3 3.3–8.7ROR 5.3 · χ² 52 / p 3e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Drug interaction	102	5.2 4.3–6.3ROR 5.4 · χ² 348 / p 6e-78	5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Hallucination, auditory	10	5.1 2.8–9.5ROR 5.1 · χ² 29 / p 3e-8	4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Psychotic disorder	18	5.0 3.1–7.9ROR 5.0 · χ² 53 / p 2e-13	4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Psychomotor hyperactivity	10	4.9 2.6–9.1ROR 4.9 · χ² 27 / p 9e-8	4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9	no trial data cached
Drug ineffective for unapproved indication	33	4.8 3.4–6.8ROR 4.9 · χ² 96 / p 5e-23	4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8 · 94% clinician	no trial data cached
Agitation	42	4.6 3.4–6.3ROR 4.7 · χ² 117 / p 2e-27	4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Hypophagia	14	4.5 2.7–7.6ROR 4.5 · χ² 35 / p 2e-9	4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached
Hospitalisation	82	4.4 3.5–5.4ROR 4.5 · χ² 212 / p 2e-48	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Abortion spontaneous	20	4.0 2.6–6.3ROR 4.1 · χ² 43 / p 3e-11	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.3 · ♀ 100% (drug 48%) · 90% clinician	no trial data cached
Crying	18	4.0 2.5–6.4ROR 4.0 · χ² 38 / p 4e-10	3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Mood swings	15	3.8 2.3–6.3ROR 3.8 · χ² 29 / p 4e-8	3.5 EB05 2.3 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Seizure	647	46.2 43.2–49.4ROR 61.3 · χ² 28,537 / p <1e-300	45.8 EB05 43.0 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.2	no trial data cached
Somnolence (drowsiness)	181	7.3 6.4–8.4ROR 7.8 · χ² 993 / p 3e-218	7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial data cached
Drug interaction	102	5.2 4.3–6.3ROR 5.4 · χ² 348 / p 6e-78	5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Generalised tonic-clonic seizure	87	43.5 35.4–53.5ROR 45.0 · χ² 3,556 / p <1e-300	42.9 EB05 35.9 · IC025 +4.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 30.9	no trial data cached
Epilepsy	83	22.2 18.0–27.4ROR 22.9 · χ² 1,658 / p <1e-300	22.1 EB05 18.3 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 17.8 · 90% clinician	no trial data cached
Hospitalisation	82	4.4 3.5–5.4ROR 4.5 · χ² 212 / p 2e-48	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial data cached
Drug resistance	77	24.5 19.6–30.5ROR 25.2 · χ² 1,708 / p <1e-300	24.3 EB05 20.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 20.7 · ♀ 86% (drug 48%) · 100% clinician	no trial data cached
Convulsion (seizure)	76	10.7 8.6–13.3ROR 11.0 · χ² 658 / p 2e-145	10.4 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5	no trial data cached
Aggression	76	12.4 9.9–15.4ROR 12.7 · χ² 783 / p 2e-172	12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.7 · ♀ 19% (drug 48%)	no trial data cached
Status epilepticus	64	46.3 36.3–59.0ROR 47.5 · χ² 2,778 / p <1e-300	45.5 EB05 36.9 · IC025 +4.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 37.2	no trial data cached
Treatment failure	58	5.8 4.5–7.4ROR 5.9 · χ² 224 / p 6e-51	5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · ♀ 19% (drug 48%)	no trial data cached
Lethargy	53	7.5 5.8–9.8ROR 7.6 · χ² 293 / p 5e-66	7.1 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Therapy non-responder	46	8.4 6.3–11.2ROR 8.5 · χ² 293 / p 5e-66	7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.1 · 91% clinician	no trial data cached
Agitation	42	4.6 3.4–6.3ROR 4.7 · χ² 117 / p 2e-27	4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Irritability	42	5.7 4.2–7.7ROR 5.8 · χ² 158 / p 2e-36	5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Sedation — n=31, PRR 9.7
Prescribed overdose — n=20, PRR 8.4
Abnormal behaviour — n=40, PRR 8.2
Lethargy — n=53, PRR 7.5
Cognitive disorder — n=39, PRR 6.8
Hypersomnia — n=24, PRR 6.8
Irritability — n=42, PRR 5.7
Anger — n=23, PRR 5.5
Agitation — n=42, PRR 4.6
Abortion spontaneous — n=20, PRR 4.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Rufinamide ↔ Convulsion.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Rufinamide?

In FDA FAERS, the most frequently co-reported reaction terms for Rufinamide are seizure, somnolence, generalised tonic-clonic seizure, epilepsy, convulsion, aggression. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Rufinamide have an FDA boxed warning?

No. The FDA label retrieved for Rufinamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Rufinamide causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 12fc41f9-b6a9-4bbd-afbe-5d269f5a42f6, effective 20230517; matched on openfda.generic_name.exact:"RUFINAMIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 62 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.