Drug · FAERS side-effect profile with label screen
Rasagiline side effects: what 3,390 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,390 reports · 68% serious · 393 with death outcome · 38% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rasagiline tablets are indicated for the treatment of Parkinson's disease (PD). Rasagiline Tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson's disease ( 1 )
FDA label, Indications and Usage
What it is
Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinson's disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate.
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 12Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 5Not in label — unassessed 17
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 156 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyskinesia (involuntary movements) | 290 | 44.5 39.9–49.7ROR 48.6 · χ² 12,234 / p <1e-300 | 44.1 EB05 40.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.6 | no trial data cached |
| Hallucination, visual | 132 | 39.2 33.1–46.3ROR 40.7 · χ² 4,843 / p <1e-300 | 38.7 EB05 33.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 30.6 | no trial data cached |
| Serotonin syndrome | 109 | 35.4 29.4–42.7ROR 36.6 · χ² 3,596 / p <1e-300 | 35.0 EB05 29.9 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.2 · 98% clinician | no trial data cached |
| Muscle rigidity | 62 | 32.2 25.2–41.3ROR 32.8 · χ² 1,838 / p <1e-300 | 31.8 EB05 25.7 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.2 | no trial data cached |
| Delusion | 79 | 31.7 25.5–39.5ROR 32.4 · χ² 2,309 / p <1e-300 | 31.3 EB05 26.0 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.3 | no trial data cached |
| Hallucination (hallucinations) | 359 | 29.8 27.0–32.8ROR 33.2 · χ² 9,938 / p <1e-300 | 29.6 EB05 27.1 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 | no trial data cached |
| Dystonia | 77 | 24.6 19.7–30.6ROR 25.1 · χ² 1,712 / p <1e-300 | 24.3 EB05 20.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.6 | no trial data cached |
| Device occlusion | 51 | 22.8 17.3–29.9ROR 23.1 · χ² 1,036 / p 1e-227 | 22.5 EB05 17.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=24 · 86% consumer | no trial data cached |
| Nocturia (night-time urination) | 38 | 19.5 14.2–26.7ROR 19.7 · χ² 646 / p 1e-142 | 19.2 EB05 14.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 | no trial data cached |
| Motor dysfunction | 25 | 15.3 10.4–22.7ROR 15.4 · χ² 320 / p 8e-72 | 14.9 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.7 | no trial data cached |
| Micturition urgency | 28 | 15.3 10.6–22.2ROR 15.4 · χ² 360 / p 2e-80 | 14.9 EB05 10.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · 93% clinician | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 43 | 15.3 11.3–20.6ROR 15.5 · χ² 559 / p 9e-124 | 15.1 EB05 11.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.3 · ♀ 13% (drug 38%) | no trial data cached |
| Parkinsonism | 20 | 12.7 8.2–19.7ROR 12.8 · χ² 204 / p 1e-46 | 11.9 EB05 7.7 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.2 | no trial data cached |
| Neuroleptic malignant syndrome | 23 | 12.0 8.0–18.0ROR 12.1 · χ² 220 / p 4e-50 | 11.2 EB05 7.5 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 · 100% clinician | no trial data cached |
| Choking | 35 | 11.2 8.0–15.5ROR 11.3 · χ² 314 / p 2e-70 | 10.7 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Paranoia | 30 | 10.7 7.5–15.3ROR 10.8 · χ² 255 / p 1e-57 | 10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Dizziness postural | 16 | 10.3 6.3–16.8ROR 10.4 · χ² 125 / p 2e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Delirium | 57 | 10.2 7.9–13.2ROR 10.4 · χ² 464 / p 3e-103 | 9.9 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · ♀ 6% (drug 38%) | no trial data cached |
| Skin laceration | 17 | 9.7 6.1–15.7ROR 9.8 · χ² 125 / p 3e-29 | 8.5 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Dementia | 42 | 9.3 6.9–12.6ROR 9.4 · χ² 304 / p 2e-68 | 8.8 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Therapeutic response shortened | 48 | 9.3 7.1–12.4ROR 9.5 · χ² 349 / p 3e-78 | 8.9 EB05 6.9 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 | no trial data cached |
| Device use issue | 26 | 9.3 6.3–13.6ROR 9.4 · χ² 184 / p 3e-42 | 8.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=8 · 88% consumer | no trial data cached |
| Balance disorder | 130 | 9.3 7.9–11.0ROR 9.6 · χ² 957 / p 2e-210 | 9.1 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Sputum discoloured | 13 | 8.5 4.9–14.7ROR 8.5 · χ² 79 / p 3e-19 | 7.0 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Tremor (shaking) | 220 | 8.2 7.2–9.3ROR 8.7 · χ² 1,392 / p <1e-300 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Poor quality sleep | 28 | 8.1 5.6–11.7ROR 8.2 · χ² 167 / p 1e-38 | 7.4 EB05 5.3 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 12.2 | no trial data cached |
| Speech disorder | 68 | 8.0 6.4–10.2ROR 8.2 · χ² 412 / p 5e-92 | 7.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 13 | 7.9 4.6–13.6ROR 7.9 · χ² 72 / p 1e-17 | 6.5 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Psychotic disorder | 37 | 7.8 5.6–10.7ROR 7.8 · χ² 211 / p 4e-48 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Cognitive disorder | 58 | 7.7 6.0–10.0ROR 7.8 · χ² 333 / p 1e-74 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · ♀ 13% (drug 38%) | no trial data cached |
| Middle insomnia | 22 | 7.3 4.8–11.1ROR 7.4 · χ² 114 / p 7e-27 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Confusional state (confusion) | 189 | 7.2 6.3–8.3ROR 7.6 · χ² 1,015 / p 6e-223 | 7.1 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Generalised tonic-clonic seizure | 19 | 7.2 4.6–11.3ROR 7.2 · χ² 95 / p 9e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Abnormal dreams | 32 | 7.1 5.0–10.1ROR 7.2 · χ² 163 / p 2e-37 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | no trial data cached |
| Nightmare | 40 | 7.1 5.2–9.7ROR 7.2 · χ² 205 / p 1e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Incontinence | 12 | 7.0 4.0–12.3ROR 7.0 · χ² 56 / p 4e-14 | 5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Drug interaction | 176 | 6.9 5.9–7.9ROR 7.2 · χ² 882 / p 4e-194 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Salivary hypersecretion | 11 | 6.8 3.8–12.3ROR 6.8 · χ² 49 / p 1e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Fall | 363 | 6.8 6.1–7.5ROR 7.5 · χ² 1,803 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Initial insomnia | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 3e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | 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 | 363 | 6.8 6.1–7.5ROR 7.5 · χ² 1,803 / p <1e-300 | 6.7 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Hallucination (hallucinations) | 359 | 29.8 27.0–32.8ROR 33.2 · χ² 9,938 / p <1e-300 | 29.6 EB05 27.1 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 | no trial data cached |
| Dyskinesia (involuntary movements) | 290 | 44.5 39.9–49.7ROR 48.6 · χ² 12,234 / p <1e-300 | 44.1 EB05 40.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.6 | no trial data cached |
| Tremor (shaking) | 220 | 8.2 7.2–9.3ROR 8.7 · χ² 1,392 / p <1e-300 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Confusional state (confusion) | 189 | 7.2 6.3–8.3ROR 7.6 · χ² 1,015 / p 6e-223 | 7.1 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Drug interaction | 176 | 6.9 5.9–7.9ROR 7.2 · χ² 882 / p 4e-194 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Condition aggravated | 164 | 3.4 2.9–3.9ROR 3.5 · χ² 273 / p 1e-61 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Constipation | 162 | 4.6 4.0–5.4ROR 4.8 · χ² 462 / p 7e-103 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Gait disturbance | 154 | 5.0 4.3–5.8ROR 5.2 · χ² 488 / p 2e-108 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Somnolence (drowsiness) | 149 | 4.6 3.9–5.4ROR 4.8 · χ² 418 / p 3e-93 | 4.5 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Product dose omission issue | 136 | 3.0 2.5–3.5ROR 3.0 · χ² 176 / p 2e-40 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 75% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 135 | 3.1 2.7–3.7ROR 3.2 · χ² 196 / p 7e-45 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Cough | 132 | 2.9 2.5–3.5ROR 3.0 · χ² 167 / p 2e-38 | 2.9 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 0.9 · 82% consumer | no trial data cached |
| Hallucination, visual | 132 | 39.2 33.1–46.3ROR 40.7 · χ² 4,843 / p <1e-300 | 38.7 EB05 33.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 30.6 | no trial data cached |
| Balance disorder | 130 | 9.3 7.9–11.0ROR 9.6 · χ² 957 / p 2e-210 | 9.1 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | 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.
- Hallucination, visual — n=132, PRR 39.2
- Nocturia — n=38, PRR 19.5
- Motor dysfunction — n=25, PRR 15.3
- Micturition urgency — n=28, PRR 15.3
- Choking — n=35, PRR 11.2
- Paranoia — n=30, PRR 10.7
- Dementia — n=42, PRR 9.3
- Balance disorder — n=130, PRR 9.3
- Speech disorder — n=68, PRR 8.0
- Middle insomnia — n=22, PRR 7.3
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 Rasagiline?
In FDA FAERS, the most frequently co-reported reaction terms for Rasagiline are fall, hallucination, dyskinesia, tremor, confusional state, constipation. 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 Rasagiline have an FDA boxed warning?
No. The FDA label retrieved for Rasagiline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Rasagiline 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 2c5e3cde-1158-4b5a-9a2b-ea6c987a65e4, effective 20260511; matched on
openfda.generic_name.exact:"RASAGILINE") - 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, fieldpatient.drug.openfda.generic_name.exact, 196 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.