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What the label lists and what reports show

Tranylcypromine side effects

Tranylcypromine's FDA label: “Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%).” FAERS holds 1,118 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (92 reports).

  • Generic listed
  • A presentation discontinued
  • Boxed warning

Check it at the source: the tranylcypromine FDA label on DailyMed (effective July 2, 2025, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of PARNATE?

PARNATE may cause serious side effects, including: See “What is the most important information I should know about PARNATE?” Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take PARNATE with certain other medicines. See, "Who should not take PARNATE?" Symptoms of serotonin syndrome may include: agitation, confusion seeing or hearing things that are not real (hallucinations) coma rapid pulse changes in blood pressure dizziness sweating flushing high body temperature (hyperthermia) fever seizures tremors, stiff muscles, or muscle twitching becoming unstable nausea, vomiting, diarrhea If you have any of these symptoms, call your healthcare provider or go to the nearest hospital emergency room right away. […]

Source: FDA drug label, Advanz Pharma (US) Corp., effective July 2, 2025 (SPL set b72d8187-dfcc-4ea0-b5e9-c0be95b69a27), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Based on clinical trial data, the most common adverse reactions to tranylcypromine were dry mouth, dizziness, insomnia, sedation, and headache (>30%) and overexcitement, constipation, blurred vision, and tremor (>10%).

From the label: adverse reactions, continued

The following adverse reactions are described in greater detail in other sections: Suicidal thoughts and behaviors [ see Warnings and Precautions (5.1)] Hypertensive crisis and hypertension [ see Warnings and Precautions (5.2)] Serotonin syndrome [see Warnings and Precautions (5.3)] Activation of mania/hypomania [see Warnings and Precautions (5.4)] Hypotension [see Warnings and Precautions (5.5)] Hypotension and hypertension during anesthesia and perioperative care [see Warnings and Precautions (5.6)] Discontinuation syndrome [ see Warnings and Precautions (5.8)] Persistence of MAO inhibition after discontinuation [see Warnings and Precautions (5.9)] Hepatotoxicity [see Warnings and Precautions (5.10)] Seizures [see Warnings and Precautions (5.11)] Hypoglycemia in diabetic patients [see Warnings and Precautions (5.12)] Aggravation of coexisting symptoms of depression [see Warnings and Precautions (5.13)] Adverse effects on the ability to drive and operate machinery [see Warnings and Precautions (5.14)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

Source: FDA drug label, Advanz Pharma (US) Corp., effective July 2, 2025 (SPL set b72d8187-dfcc-4ea0-b5e9-c0be95b69a27), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,118 reports list tranylcypromine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 89 are coded as a death and 328 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Interaction (a use or a product term, not a reaction)145
  • Drug Ineffective (a use or a product term, not a reaction)125
  • Depression (a use or a product term, not a reaction)119
  • Headache (named in the label)92
  • Contraindicated Product Administered82
  • Hypertensive Crisis (named in the label)81
  • Insomnia (named in the label)81
  • Nausea (named in the label)75
  • Hypertension (named in the label)69
  • Suicidal Ideation66
  • Fatigue (named in the label)63
  • Anxiety (named in the label)62
  • Serotonin Syndrome (named in the label)61
  • Hyperhidrosis60
  • Dizziness (named in the label)57
  • Weight Increased50
  • Muscle Spasms49
  • Off Label Use (a use or a product term, not a reaction)48
  • Tremor (named in the label)47
  • Agitation (named in the label)46
  • Overdose (a use or a product term, not a reaction)46
  • Dyspnoea45
  • Potentiating Drug Interaction (a use or a product term, not a reaction)44
  • Completed Suicide (an outcome recorded in the report)42
  • Asthenia40

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tranylcypromine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions