Selegiline side effects: what 2,965 FDA adverse event reports show
Drug class
Monoamine Oxidase Inhibitor, Monoamine Oxidase Type B Inhibitor
Brand names
Emsam
Who reports
2,965 reports · 47% serious · 170 with death outcome · 55% female
Used for
EMSAM (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of adults with major depressive disorder (MDD) . EMSAM ® (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) ( 1 ).
What it is
EMSAM ® contains selegiline, a MAOI antidepressant. When applied to intact skin, EMSAM is designed to transdermally deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-( N )-Methyl- N -[(1 R )-1-methyl-2-phenylethyl]prop-2-yn-1-amine.
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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. 90 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Application site rash | 126 | 65.2 54.9–77.4ROR 68.0 · χ² 7,832 / p <1e-300 | 64.0 EB05 55.2 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Application site erythema | 183 | 49.5 43.0–57.0ROR 52.7 · χ² 8,604 / p <1e-300 | 49.0 EB05 43.3 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=17 · 71% consumer | no trial data cached |
| Application site pruritus | 120 | 37.6 31.5–44.8ROR 39.1 · χ² 4,220 / p <1e-300 | 37.2 EB05 31.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · ♀ 78% (drug 55%) · 74% consumer | no trial data cached |
| Application site irritation | 62 | 35.4 27.7–45.3ROR 36.2 · χ² 2,030 / p <1e-300 | 34.9 EB05 28.2 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Hallucination, visual | 73 | 24.7 19.7–31.0ROR 25.3 · χ² 1,632 / p <1e-300 | 24.5 EB05 20.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.9 | no trial data cached |
| Dyskinesia (involuntary movements) | 139 | 24.3 20.7–28.6ROR 25.5 · χ² 3,081 / p <1e-300 | 24.2 EB05 21.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 | no trial data cached |
| Delusion | 40 | 18.3 13.5–24.9ROR 18.6 · χ² 636 / p 1e-140 | 18.1 EB05 13.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 | no trial data cached |
| Serotonin syndrome | 49 | 18.2 13.8–24.0ROR 18.5 · χ² 776 / p 4e-171 | 18.0 EB05 14.1 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.0 | no trial data cached |
| Muscle rigidity | 28 | 16.6 11.5–24.0ROR 16.8 · χ² 395 / p 4e-88 | 16.3 EB05 11.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 | no trial data cached |
| Hallucination (hallucinations) | 170 | 16.1 13.9–18.6ROR 17.0 · χ² 2,392 / p <1e-300 | 16.0 EB05 14.1 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.8 · ♀ 23% (drug 55%) | no trial data cached |
| Neuroleptic malignant syndrome | 22 | 13.1 8.6–19.9ROR 13.2 · χ² 234 / p 4e-53 | 12.4 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 16.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 32 | 13.0 9.2–18.3ROR 13.1 · χ² 342 / p 1e-76 | 12.6 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · ♀ 27% (drug 55%) | no trial data cached |
| Application site pain | 38 | 12.2 8.9–16.8ROR 12.4 · χ² 380 / p 5e-85 | 11.8 EB05 8.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=1 · ♀ 79% (drug 55%) · 74% consumer | no trial data cached |
| Parkinsonism | 16 | 11.6 7.1–19.0ROR 11.7 · χ² 145 / p 1e-33 | 10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Product adhesion issue | 53 | 10.6 8.1–13.8ROR 10.8 · χ² 451 / p 2e-100 | 10.2 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=4 · 87% consumer | no trial data cached |
| Hypertensive crisis | 16 | 10.2 6.2–16.6ROR 10.2 · χ² 123 / p 7e-29 | 8.8 EB05 5.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.5 | no trial data cached |
| Dermatitis contact | 16 | 10.0 6.1–16.3ROR 10.0 · χ² 120 / p 3e-28 | 8.7 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Hypokinesia | 17 | 8.3 5.2–13.3ROR 8.3 · χ² 102 / p 3e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Motor dysfunction | 11 | 7.7 4.3–13.9ROR 7.7 · χ² 58 / p 2e-14 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Psychomotor hyperactivity | 18 | 7.6 4.8–12.1ROR 7.7 · χ² 97 / p 3e-23 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 | no trial data cached |
| Paranoia | 18 | 7.4 4.6–11.7ROR 7.4 · χ² 93 / p 3e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Drug effect decreased | 51 | 6.6 5.0–8.7ROR 6.7 · χ² 238 / p 7e-54 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Dystonia | 18 | 6.5 4.1–10.4ROR 6.6 · χ² 79 / p 3e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Mania | 15 | 6.5 3.9–10.7ROR 6.5 · χ² 64 / p 7e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.2 | no trial data cached |
| Abnormal dreams | 24 | 6.1 4.1–9.1ROR 6.2 · χ² 98 / p 3e-23 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 | no trial data cached |
| Nightmare | 30 | 6.1 4.3–8.7ROR 6.2 · χ² 123 / p 6e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Drug interaction | 134 | 6.0 5.1–7.1ROR 6.2 · χ² 554 / p 7e-123 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Abnormal behaviour | 33 | 5.9 4.2–8.2ROR 5.9 · χ² 128 / p 5e-30 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Device occlusion | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 6e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Therapeutic response shortened | 25 | 5.6 3.8–8.2ROR 5.6 · χ² 89 / p 2e-21 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Agitation | 57 | 5.5 4.2–7.1ROR 5.6 · χ² 205 / p 9e-47 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Choking | 15 | 5.5 3.3–9.1ROR 5.5 · χ² 50 / p 6e-13 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Akathisia (inner restlessness) | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Gait inability | 24 | 5.1 3.4–7.6ROR 5.2 · χ² 76 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 35% (drug 55%) | no trial data cached |
| Tremor (shaking) | 119 | 5.1 4.2–6.0ROR 5.2 · χ² 387 / p 2e-86 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Confusional state (confusion) | 115 | 5.0 4.2–6.0ROR 5.2 · χ² 370 / p 1e-82 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Middle insomnia | 13 | 4.9 2.9–8.5ROR 5.0 · χ² 37 / p 6e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Irritability | 42 | 4.9 3.7–6.7ROR 5.0 · χ² 128 / p 5e-30 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Insomnia (trouble sleeping) | 186 | 4.9 4.3–5.7ROR 5.2 · χ² 587 / p 6e-130 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 77% consumer | no trial data cached |
| Dysarthria (slurred speech) | 26 | 4.9 3.3–7.2ROR 4.9 · χ² 77 / p 1e-18 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Insomnia (trouble sleeping) | 186 | 4.9 4.3–5.7ROR 5.2 · χ² 587 / p 6e-130 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 77% consumer | no trial data cached |
| Application site erythema | 183 | 49.5 43.0–57.0ROR 52.7 · χ² 8,604 / p <1e-300 | 49.0 EB05 43.3 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=17 · 71% consumer | no trial data cached |
| Hallucination (hallucinations) | 170 | 16.1 13.9–18.6ROR 17.0 · χ² 2,392 / p <1e-300 | 16.0 EB05 14.1 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.8 · ♀ 23% (drug 55%) | no trial data cached |
| Dyskinesia (involuntary movements) | 139 | 24.3 20.7–28.6ROR 25.5 · χ² 3,081 / p <1e-300 | 24.2 EB05 21.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 | no trial data cached |
| Drug interaction | 134 | 6.0 5.1–7.1ROR 6.2 · χ² 554 / p 7e-123 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Depression | 128 | 4.0 3.3–4.7ROR 4.1 · χ² 284 / p 6e-64 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.1 | no trial data cached |
| Application site rash | 126 | 65.2 54.9–77.4ROR 68.0 · χ² 7,832 / p <1e-300 | 64.0 EB05 55.2 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Application site pruritus | 120 | 37.6 31.5–44.8ROR 39.1 · χ² 4,220 / p <1e-300 | 37.2 EB05 31.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · ♀ 78% (drug 55%) · 74% consumer | no trial data cached |
| Tremor (shaking) | 119 | 5.1 4.2–6.0ROR 5.2 · χ² 387 / p 2e-86 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Confusional state (confusion) | 115 | 5.0 4.2–6.0ROR 5.2 · χ² 370 / p 1e-82 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Somnolence (drowsiness) | 106 | 3.7 3.1–4.5ROR 3.8 · χ² 211 / p 4e-48 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Hallucination, visual | 73 | 24.7 19.7–31.0ROR 25.3 · χ² 1,632 / p <1e-300 | 24.5 EB05 20.1 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 27.9 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 67 | 3.7 2.9–4.7ROR 3.7 · χ² 129 / p 4e-30 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Application site irritation | 62 | 35.4 27.7–45.3ROR 36.2 · χ² 2,030 / p <1e-300 | 34.9 EB05 28.2 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious n=7 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 60 | 4.6 3.6–6.0ROR 4.7 · χ² 168 / p 1e-38 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.8 | 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.
- Dyskinesia — n=139, PRR 24.3
- Delusion — n=40, PRR 18.3
- Muscle rigidity — n=28, PRR 16.6
- Neuroleptic malignant syndrome — n=22, PRR 13.1
- Orthostatic hypotension — n=32, PRR 13.0
- Abnormal dreams — n=24, PRR 6.1
- Nightmare — n=30, PRR 6.1
- Abnormal behaviour — n=33, PRR 5.9
- Gait inability — n=24, PRR 5.1
- Confusional state — n=115, PRR 5.0
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 Selegiline?
In FDA FAERS, the most frequently co-reported reaction terms for Selegiline are insomnia, application site erythema, hallucination, dyskinesia, depression, application site rash. 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 Selegiline have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Selegiline 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 b891bd9f-fdb8-4862-89c5-ecdd700398a3, effective 20200515; matched on
openfda.generic_name.exact:"SELEGILINE") - 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, 130 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.