Safinamide side effects: what 433 FDA adverse event reports show

Safinamide Mesylate · 65 reaction terms · 1,691 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

433 reports · 96% serious · 39 with death outcome · 42% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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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

Reporting / coding artifact 9No label text to screen 31

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 25 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
Dyskinesia (involuntary movements)	153	60.1 51.7–69.7ROR 67.8 · χ² 8,810 / p <1e-300	59.4 EB05 51.9 · IC025 +5.4 3/3 methods agree	No label text to screen	–	no trial data cached
Muscle rigidity	34	45.2 32.5–63.1ROR 46.4 · χ² 1,424 / p <1e-300	44.1 EB05 33.0 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Hypokinesia	38	41.6 30.4–56.9ROR 42.8 · χ² 1,462 / p <1e-300	40.7 EB05 31.0 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Delusion	34	34.9 25.0–48.6ROR 35.8 · χ² 1,084 / p 5e-238	34.2 EB05 25.6 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Hallucination (hallucinations)	155	32.9 28.3–38.1ROR 37.1 · χ² 4,764 / p <1e-300	32.7 EB05 28.6 · IC025 +4.6 3/3 methods agree	No label text to screen	–	no trial data cached
Hallucination, visual	38	28.8 21.0–39.4ROR 29.6 · χ² 990 / p 1e-217	28.4 EB05 21.6 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Device occlusion	23	26.3 17.5–39.4ROR 26.7 · χ² 534 / p 2e-118	25.7 EB05 18.0 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Dystonia	30	24.5 17.2–34.9ROR 25.0 · χ² 652 / p 4e-144	24.1 EB05 17.7 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Anosmia (loss of smell)	19	20.8 13.3–32.5ROR 21.1 · χ² 338 / p 7e-76	20.3 EB05 13.6 · IC025 +3.0 3/3 methods agree	No label text to screen	–	no trial data cached
Motor dysfunction	12	18.8 10.7–33.1ROR 19.0 · χ² 185 / p 2e-42	17.9 EB05 10.2 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Therapeutic response shortened	34	17.0 12.2–23.6ROR 17.4 · χ² 495 / p 6e-110	16.7 EB05 12.4 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Infusion site pain	13	16.2 9.4–27.8ROR 16.3 · χ² 170 / p 4e-39	15.2 EB05 8.6 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Embedded device	10	16.1 8.7–29.9ROR 16.2 · χ² 127 / p 9e-30	14.6 EB05 7.3 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Dementia	24	13.7 9.2–20.3ROR 13.9 · χ² 270 / p 7e-61	13.1 EB05 8.9 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Psychotic disorder	25	13.4 9.1–19.8ROR 13.7 · χ² 276 / p 3e-62	12.9 EB05 8.8 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Device dislocation	36	13.2 9.5–18.2ROR 13.5 · χ² 393 / p 9e-88	12.8 EB05 9.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Mobility decreased	56	12.4 9.6–16.0ROR 12.9 · χ² 578 / p 6e-128	12.2 EB05 9.6 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Gait inability	24	11.5 7.7–17.1ROR 11.7 · χ² 220 / p 4e-50	10.8 EB05 7.3 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Head injury	21	10.6 6.9–16.1ROR 10.7 · χ² 172 / p 1e-39	9.6 EB05 6.3 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Dysarthria (slurred speech)	25	10.5 7.2–15.6ROR 10.7 · χ² 207 / p 3e-47	9.8 EB05 6.7 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Device issue	56	10.2 7.9–13.2ROR 10.6 · χ² 456 / p 1e-101	9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Speech disorder	33	10.0 7.1–14.0ROR 10.2 · χ² 259 / p 2e-58	9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Unresponsive to stimuli	16	9.9 6.1–16.1ROR 10.0 · χ² 119 / p 5e-28	8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Cognitive disorder	28	9.6 6.6–13.8ROR 9.7 · χ² 206 / p 5e-47	8.8 EB05 6.2 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Disorientation	23	9.2 6.1–13.8ROR 9.3 · χ² 160 / p 6e-37	8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Device use issue	10	9.2 4.9–17.0ROR 9.2 · χ² 65 / p 4e-16	7.2 EB05 3.9 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Tremor (shaking)	87	8.3 6.8–10.2ROR 8.8 · χ² 556 / p 3e-123	8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Restlessness	19	8.2 5.3–12.9ROR 8.3 · χ² 114 / p 8e-27	7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree	No label text to screen	–	no trial data cached
Gait disturbance	99	8.2 6.8–9.9ROR 8.8 · χ² 623 / p 1e-137	8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Mental disorder	22	8.0 5.3–12.1ROR 8.1 · χ² 128 / p 5e-30	7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Fall	166	7.9 6.9–9.1ROR 8.9 · χ² 1,013 / p 1e-222	7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Aggression	25	7.9 5.4–11.7ROR 8.0 · χ² 144 / p 2e-33	7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Hip fracture	15	7.4 4.5–12.3ROR 7.5 · χ² 77 / p 8e-19	6.3 EB05 4.0 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Balance disorder	40	7.3 5.4–9.9ROR 7.5 · χ² 213 / p 1e-48	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Incorrect dose administered by device	11	6.9 3.8–12.4ROR 6.9 · χ² 50 / p 1e-12	5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Epilepsy	13	6.8 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14	5.6 EB05 3.5 · IC025 +1.5 3/3 methods agree	No label text to screen	–	no trial data cached
Depressed mood	20	6.0 3.9–9.3ROR 6.1 · χ² 79 / p 3e-19	5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	No label text to screen	–	no trial data cached
Unevaluable event	25	5.2 3.6–7.7ROR 5.3 · χ² 82 / p 7e-20	4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Wrong technique in device usage process	15	5.2 3.1–8.6ROR 5.3 · χ² 47 / p 4e-12	4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Device difficult to use	18	4.3 2.7–6.8ROR 4.4 · χ² 43 / p 3e-11	3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	–	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
Fall	166	7.9 6.9–9.1ROR 8.9 · χ² 1,013 / p 1e-222	7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Hallucination (hallucinations)	155	32.9 28.3–38.1ROR 37.1 · χ² 4,764 / p <1e-300	32.7 EB05 28.6 · IC025 +4.6 3/3 methods agree	No label text to screen	–	no trial data cached
Dyskinesia (involuntary movements)	153	60.1 51.7–69.7ROR 67.8 · χ² 8,810 / p <1e-300	59.4 EB05 51.9 · IC025 +5.4 3/3 methods agree	No label text to screen	–	no trial data cached
Gait disturbance	99	8.2 6.8–9.9ROR 8.8 · χ² 623 / p 1e-137	8.0 EB05 6.7 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Tremor (shaking)	87	8.3 6.8–10.2ROR 8.8 · χ² 556 / p 3e-123	8.1 EB05 6.7 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Device issue	56	10.2 7.9–13.2ROR 10.6 · χ² 456 / p 1e-101	9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Mobility decreased	56	12.4 9.6–16.0ROR 12.9 · χ² 578 / p 6e-128	12.2 EB05 9.6 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Balance disorder	40	7.3 5.4–9.9ROR 7.5 · χ² 213 / p 1e-48	6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Hallucination, visual	38	28.8 21.0–39.4ROR 29.6 · χ² 990 / p 1e-217	28.4 EB05 21.6 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Hypokinesia	38	41.6 30.4–56.9ROR 42.8 · χ² 1,462 / p <1e-300	40.7 EB05 31.0 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Device dislocation	36	13.2 9.5–18.2ROR 13.5 · χ² 393 / p 9e-88	12.8 EB05 9.5 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Therapeutic response shortened	34	17.0 12.2–23.6ROR 17.4 · χ² 495 / p 6e-110	16.7 EB05 12.4 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Delusion	34	34.9 25.0–48.6ROR 35.8 · χ² 1,084 / p 5e-238	34.2 EB05 25.6 · IC025 +4.0 3/3 methods agree	No label text to screen	–	no trial data cached
Muscle rigidity	34	45.2 32.5–63.1ROR 46.4 · χ² 1,424 / p <1e-300	44.1 EB05 33.0 · IC025 +4.2 3/3 methods agree	No label text to screen	–	no trial data cached
Speech disorder	33	10.0 7.1–14.0ROR 10.2 · χ² 259 / p 2e-58	9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Safinamide?

In FDA FAERS, the most frequently co-reported reaction terms for Safinamide are fall, hallucination, dyskinesia, gait disturbance, tremor, mobility decreased. 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 Safinamide have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Safinamide 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 65 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.