Drug · FAERS side-effect profile with label screen
Rasagiline Mesylate side effects: what 11,067 FDA adverse event reports show
Drug class
Not stated in label
Who reports
11,067 reports · 67% serious · 1,236 with death outcome · 40% 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 (related wording) 3Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 35
What the badges mean
- 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. 989 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 |
|---|---|---|---|---|---|---|
| Dopamine agonist withdrawal syndrome | 12 | 560.7 294.2–1,068.5ROR 561.3 · χ² 4,735 / p <1e-300 | 255.9 EB05 156.0 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Cerebral hypoperfusion | 68 | 330.1 255.2–426.9ROR 332.1 · χ² 18,683 / p <1e-300 | 260.2 EB05 212.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 0% (drug 40%) | no trial data cached |
| Dopamine dysregulation syndrome | 47 | 222.4 164.4–300.7ROR 223.3 · χ² 9,060 / p <1e-300 | 184.1 EB05 144.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 19% (drug 40%) | no trial data cached |
| Binocular eye movement disorder | 28 | 210.2 142.3–310.5ROR 210.7 · χ² 5,053 / p <1e-300 | 167.6 EB05 121.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 40%) | no trial data cached |
| Supine hypertension | 16 | 174.9 104.8–291.8ROR 175.1 · χ² 2,373 / p <1e-300 | 134.7 EB05 87.9 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Cerebellar stroke | 29 | 158.9 108.8–232.1ROR 159.4 · χ² 4,050 / p <1e-300 | 133.8 EB05 97.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 0% (drug 40%) | no trial data cached |
| Blood lactic acid | 10 | 158.4 83.1–302.0ROR 158.5 · χ² 1,300 / p 5e-285 | 114.7 EB05 66.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Paraphilia | 10 | 155.7 81.7–296.8ROR 155.9 · χ² 1,280 / p 1e-280 | 113.4 EB05 65.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Jealous delusion | 20 | 143.2 90.9–225.6ROR 143.5 · χ² 2,493 / p <1e-300 | 118.3 EB05 80.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Hypersexuality | 118 | 130.3 108.2–156.8ROR 131.7 · χ² 14,030 / p <1e-300 | 119.5 EB05 102.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=97 · ♀ 18% (drug 40%) | no trial data cached |
| Obsessive-compulsive personality disorder | 16 | 128.3 77.4–212.9ROR 128.5 · χ² 1,774 / p <1e-300 | 105.4 EB05 68.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Freezing phenomenon | 204 | 113.9 99.0–131.1ROR 116.1 · χ² 21,424 / p <1e-300 | 106.4 EB05 94.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=157 | no trial data cached |
| Impulse-control disorder | 112 | 109.0 90.1–131.7ROR 110.1 · χ² 11,220 / p <1e-300 | 101.3 EB05 86.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 18% (drug 40%) | no trial data cached |
| On and off phenomenon | 267 | 101.2 89.6–114.3ROR 103.7 · χ² 25,044 / p <1e-300 | 95.4 EB05 86.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=224 | no trial data cached |
| Resting tremor | 31 | 95.0 66.2–136.2ROR 95.2 · χ² 2,655 / p <1e-300 | 85.8 EB05 63.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Stoma site hypergranulation | 30 | 94.4 65.4–136.1ROR 94.6 · χ² 2,551 / p <1e-300 | 85.2 EB05 62.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Rapid eye movement sleep behaviour disorder | 18 | 89.5 55.8–143.5ROR 89.6 · χ² 1,419 / p <1e-300 | 78.6 EB05 52.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Saliva discolouration | 14 | 83.9 49.1–143.2ROR 84.0 · χ² 1,019 / p 6e-224 | 72.7 EB05 46.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Camptocormia | 10 | 82.7 43.9–155.8ROR 82.8 · χ² 697 / p 8e-154 | 69.2 EB05 40.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Stoma site erythema | 76 | 80.2 63.8–100.9ROR 80.8 · χ² 5,628 / p <1e-300 | 75.6 EB05 62.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=67 | no trial data cached |
| Pathological gambling | 61 | 71.3 55.2–92.0ROR 71.6 · χ² 4,003 / p <1e-300 | 67.3 EB05 54.3 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=45 | no trial data cached |
| Deep brain stimulation | 21 | 71.0 45.9–109.7ROR 71.1 · χ² 1,329 / p 3e-291 | 64.6 EB05 44.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=20 · 81% consumer | no trial data cached |
| Stoma site discharge | 95 | 68.0 55.5–83.4ROR 68.6 · χ² 5,988 / p <1e-300 | 64.8 EB05 54.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=84 | no trial data cached |
| Sudden onset of sleep | 44 | 61.8 45.8–83.4ROR 62.0 · χ² 2,489 / p <1e-300 | 58.4 EB05 45.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=43 | no trial data cached |
| Stoma site infection | 40 | 60.5 44.2–82.8ROR 60.7 · χ² 2,209 / p <1e-300 | 57.1 EB05 43.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Labelled drug-food interaction medication error | 15 | 58.2 34.8–97.2ROR 58.2 · χ² 763 / p 3e-168 | 52.9 EB05 34.0 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Mesenteric artery thrombosis | 11 | 55.7 30.6–101.5ROR 55.8 · χ² 522 / p 8e-116 | 49.8 EB05 29.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Stoma site extravasation | 11 | 54.8 30.1–99.8ROR 54.9 · χ² 514 / p 5e-114 | 49.1 EB05 29.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Reduced facial expression | 28 | 54.5 37.4–79.3ROR 54.6 · χ² 1,376 / p <1e-300 | 51.2 EB05 37.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 15% (drug 40%) | no trial data cached |
| Akinesia | 53 | 49.8 37.9–65.4ROR 50.0 · χ² 2,422 / p <1e-300 | 47.8 EB05 37.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=47 | no trial data cached |
| Stoma site irritation | 14 | 49.7 29.3–84.5ROR 49.8 · χ² 605 / p 8e-134 | 45.7 EB05 28.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Compulsive shopping | 52 | 48.8 37.1–64.2ROR 49.0 · χ² 2,327 / p <1e-300 | 46.8 EB05 37.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Device colour issue | 10 | 48.5 25.9–90.9ROR 48.6 · χ² 409 / p 4e-91 | 43.7 EB05 25.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Bradykinesia | 139 | 46.3 39.1–54.7ROR 46.8 · χ² 5,964 / p <1e-300 | 44.9 EB05 39.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=128 | no trial data cached |
| Delusional disorder, persecutory type | 10 | 45.8 24.5–85.8ROR 45.8 · χ² 385 / p 5e-86 | 41.5 EB05 24.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Stoma site pain | 34 | 45.1 32.1–63.3ROR 45.2 · χ² 1,388 / p <1e-300 | 43.0 EB05 32.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 | no trial data cached |
| Sleep attacks | 11 | 45.0 24.7–81.8ROR 45.0 · χ² 420 / p 1e-93 | 41.1 EB05 24.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Pleurothotonus | 21 | 44.7 29.0–68.8ROR 44.7 · χ² 833 / p 2e-183 | 42.1 EB05 29.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Parkinsonian gait | 14 | 43.6 25.7–74.1ROR 43.7 · χ² 529 / p 3e-117 | 40.5 EB05 25.6 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=9 | no trial data cached |
| Stereotypy | 21 | 43.4 28.2–66.9ROR 43.5 · χ² 810 / p 2e-178 | 41.0 EB05 28.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 | 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 | 1,066 | 6.1 5.8–6.5ROR 6.6 · χ² 4,590 / p <1e-300 | 6.1 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Hallucination (hallucinations) | 959 | 24.5 23.1–26.1ROR 26.8 · χ² 21,435 / p <1e-300 | 24.2 EB05 23.0 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 | no trial data cached |
| Dyskinesia (involuntary movements) | 765 | 36.4 34.0–39.0ROR 39.0 · χ² 25,860 / p <1e-300 | 35.7 EB05 33.6 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.6 | no trial data cached |
| Drug ineffective (drug did not work) | 756 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.009 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Dizziness | 659 | 2.5 2.3–2.7ROR 2.6 · χ² 611 / p 3e-135 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Tremor (shaking) | 651 | 7.4 6.9–8.0ROR 7.8 · χ² 3,641 / p <1e-300 | 7.4 EB05 6.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Death | 625 | 1.4 1.3–1.5ROR 1.4 · χ² 66 / p 2e-16 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Confusional state (confusion) | 547 | 6.4 5.9–7.0ROR 6.7 · χ² 2,509 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Gait disturbance | 512 | 5.1 4.7–5.5ROR 5.3 · χ² 1,678 / p <1e-300 | 5.0 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Somnolence (drowsiness) | 507 | 4.8 4.4–5.2ROR 5.0 · χ² 1,527 / p <1e-300 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Nausea | 488 | 1.2 1.1–1.3ROR 1.2 · χ² 13 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Fatigue (tiredness) | 474 | 1.2 1.1–1.3ROR 1.2 · χ² 10 / p 7e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled (related wording) related wording | serious PRR 1.1 | no trial data cached |
| Constipation | 413 | 3.6 3.3–4.0ROR 3.7 · χ² 788 / p 1e-173 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Insomnia (trouble sleeping) | 371 | 2.6 2.4–2.9ROR 2.7 · χ² 380 / p 7e-85 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Drug interaction | 364 | 4.4 3.9–4.8ROR 4.5 · χ² 942 / p 3e-207 | 4.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | 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.
- Cerebral hypoperfusion — n=68, PRR 330.1
- Dopamine dysregulation syndrome — n=47, PRR 222.4
- Binocular eye movement disorder — n=28, PRR 210.2
- Cerebellar stroke — n=29, PRR 158.9
- Jealous delusion — n=20, PRR 143.2
- Hypersexuality — n=118, PRR 130.3
- Freezing phenomenon — n=204, PRR 113.9
- Impulse-control disorder — n=112, PRR 109.0
- On and off phenomenon — n=267, PRR 101.2
- Resting tremor — n=31, PRR 95.0
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, dizziness, tremor, confusional state. 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, 1,029 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.