Tranylcypromine side effects: what 341 FDA adverse event reports show
Drug class
Not stated in label
Who reports
341 reports · 92% serious · 50 with death outcome · 64% female
Used for
Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to t.
What it is
Tranylcypromine sulfate, the active ingredient of Tranylcypromine Tablets, USP, is a non-hydrazine MAOI.
Boxed warning
SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE See full prescribing information for complete boxed warning. • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants.
Causality screen of the 22 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 3 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 |
|---|---|---|---|---|---|---|
| Hypertensive crisis | 23 | 126.9 85.5–188.4ROR 136.0 · χ² 2,745 / p <1e-300 | 114.8 EB05 80.6 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 79.2 · ♀ 100% (drug 64%) | no trial data cached |
| Serotonin syndrome | 27 | 86.9 60.5–124.9ROR 94.3 · χ² 2,207 / p <1e-300 | 81.9 EB05 59.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 54.6 | no trial data cached |
| Neuroleptic malignant syndrome | 16 | 82.8 51.3–133.7ROR 86.9 · χ² 1,212 / p 7e-266 | 75.5 EB05 49.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 51.8 | no trial data cached |
| Contraindicated product administered | 22 | 44.9 30.0–67.2ROR 47.9 · χ² 901 / p 3e-198 | 43.3 EB05 30.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 34.8 · ♀ 86% (drug 64%) · 91% clinician | no trial data cached |
| Gastrointestinal carcinoma | 6 | 40.2 18.2–88.9ROR 40.9 · χ² 192 / p 6e-44 | 35.7 EB05 17.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 | no trial data cached |
| Prescribed overdose | 12 | 38.2 21.9–66.5ROR 39.5 · χ² 398 / p 8e-89 | 36.1 EB05 22.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.2 | no trial data cached |
| Myoclonus | 7 | 36.1 17.3–75.2ROR 36.9 · χ² 205 / p 8e-47 | 32.9 EB05 16.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 23.8 | no trial data cached |
| Thrombotic microangiopathy | 5 | 31.8 13.3–75.8ROR 32.2 · χ² 120 / p 4e-28 | 27.3 EB05 10.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 | no trial data cached |
| Dystonia | 10 | 31.6 17.2–58.2ROR 32.5 · χ² 267 / p 3e-60 | 29.9 EB05 17.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 | no trial data cached |
| Wrist fracture | 6 | 30.8 13.9–68.1ROR 31.3 · χ² 144 / p 1e-33 | 27.6 EB05 12.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.5 | no trial data cached |
| Blood pressure fluctuation | 12 | 30.7 17.6–53.5ROR 31.8 · χ² 316 / p 7e-71 | 29.3 EB05 17.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 24.1 | no trial data cached |
| Muscle twitching | 11 | 29.3 16.4–52.4ROR 30.2 · χ² 273 / p 1e-61 | 27.9 EB05 16.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 | no trial data cached |
| Mood swings | 13 | 25.1 14.7–42.7ROR 26.0 · χ² 277 / p 2e-62 | 24.2 EB05 14.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | no trial data cached |
| Haemorrhage intracranial | 6 | 24.6 11.1–54.4ROR 25.0 · χ² 113 / p 9e-27 | 21.7 EB05 8.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Apathy | 5 | 21.2 8.9–50.5ROR 21.5 · χ² 77 / p 9e-19 | 16.9 EB05 5.4 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.1 | no trial data cached |
| Anger | 9 | 16.3 8.6–31.1ROR 16.7 · χ² 115 / p 5e-27 | 14.5 EB05 6.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 24 | 16.1 11.0–23.7ROR 17.2 · χ² 326 / p 3e-73 | 15.7 EB05 10.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.4 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 15.1 7.3–31.5ROR 15.4 · χ² 79 / p 4e-19 | 12.2 EB05 5.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Foetal exposure during pregnancy | 19 | 14.4 9.3–22.3ROR 15.2 · χ² 224 / p 5e-51 | 13.7 EB05 8.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 | no trial data cached |
| Completed suicide (death by suicide) | 19 | 13.9 9.0–21.5ROR 14.6 · χ² 215 / p 5e-49 | 13.2 EB05 8.4 · IC025 +2.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 8.6 | no trial data cached |
| Drug effective for unapproved indication | 6 | 12.6 5.7–27.9ROR 12.8 · χ² 53 / p 1e-13 | 9.0 EB05 3.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Drug withdrawal syndrome | 8 | 5.5 2.8–11.0ROR 5.7 · χ² 26 / p 2e-7 | 4.3 EB05 2.4 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | 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 |
|---|---|---|---|---|---|---|
| Serotonin syndrome | 27 | 86.9 60.5–124.9ROR 94.3 · χ² 2,207 / p <1e-300 | 81.9 EB05 59.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 54.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 24 | 16.1 11.0–23.7ROR 17.2 · χ² 326 / p 3e-73 | 15.7 EB05 10.9 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.4 | no trial data cached |
| Hypertensive crisis | 23 | 126.9 85.5–188.4ROR 136.0 · χ² 2,745 / p <1e-300 | 114.8 EB05 80.6 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 79.2 · ♀ 100% (drug 64%) | no trial data cached |
| Contraindicated product administered | 22 | 44.9 30.0–67.2ROR 47.9 · χ² 901 / p 3e-198 | 43.3 EB05 30.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 34.8 · ♀ 86% (drug 64%) · 91% clinician | no trial data cached |
| Completed suicide (death by suicide) | 19 | 13.9 9.0–21.5ROR 14.6 · χ² 215 / p 5e-49 | 13.2 EB05 8.4 · IC025 +2.6 3/3 methods agree | Outcome field, not a reaction | serious PRR 8.6 | no trial data cached |
| Foetal exposure during pregnancy | 19 | 14.4 9.3–22.3ROR 15.2 · χ² 224 / p 5e-51 | 13.7 EB05 8.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.2 | no trial data cached |
| Neuroleptic malignant syndrome | 16 | 82.8 51.3–133.7ROR 86.9 · χ² 1,212 / p 7e-266 | 75.5 EB05 49.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 51.8 | no trial data cached |
| Mood swings | 13 | 25.1 14.7–42.7ROR 26.0 · χ² 277 / p 2e-62 | 24.2 EB05 14.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | no trial data cached |
| Blood pressure fluctuation | 12 | 30.7 17.6–53.5ROR 31.8 · χ² 316 / p 7e-71 | 29.3 EB05 17.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 24.1 | no trial data cached |
| Prescribed overdose | 12 | 38.2 21.9–66.5ROR 39.5 · χ² 398 / p 8e-89 | 36.1 EB05 22.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 37.2 | no trial data cached |
| Muscle twitching | 11 | 29.3 16.4–52.4ROR 30.2 · χ² 273 / p 1e-61 | 27.9 EB05 16.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 28.4 | no trial data cached |
| Dystonia | 10 | 31.6 17.2–58.2ROR 32.5 · χ² 267 / p 3e-60 | 29.9 EB05 17.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.7 | no trial data cached |
| Anger | 9 | 16.3 8.6–31.1ROR 16.7 · χ² 115 / p 5e-27 | 14.5 EB05 6.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 | no trial data cached |
| Drug withdrawal syndrome | 8 | 5.5 2.8–11.0ROR 5.7 · χ² 26 / p 2e-7 | 4.3 EB05 2.4 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Tardive dyskinesia (persistent involuntary movements) | 7 | 15.1 7.3–31.5ROR 15.4 · χ² 79 / p 4e-19 | 12.2 EB05 5.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | 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 Tranylcypromine?
In FDA FAERS, the most frequently co-reported reaction terms for Tranylcypromine are serotonin syndrome, suicidal ideation, hypertensive crisis, neuroleptic malignant syndrome, mood swings, blood pressure fluctuation. 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 Tranylcypromine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE See full prescribing information for complete boxed warning. • Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants.
Do FAERS signals prove that Tranylcypromine 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 3c14a558-2df4-4d93-97dd-640dec6ee785, effective 20241220; matched on
openfda.generic_name.exact:"TRANYLCYPROMINE") - 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, 25 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.