Tranylcypromine
Tranylcypromin Aristo · ATC code N06AF04
Also known as: Tranylcypromin, Tranilsipromin, Tranylcypromine Sulfate
- Key facts
- Active substance
- Tranylcypromine
- Drug class
- Monoamine oxidase inhibitor
- ATC code
- N06AF04
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
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)] . Tranylcypromine sulfate tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
Hypertensive Crisis with Significant Tyramine Use
Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine sulfate tablets or after tranylcypromine sulfate tablets discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine sulfate tablets and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content [see Warnings and Precautions (5.2) and Drug Interactions (7.1, 7.2)].
Key facts
Tranylcypromine is a monoamine oxidase inhibitor (MAOI). Per the US prescribing information, it is used in adults with major depressive disorder who have not responded adequately to other antidepressants.
What it is used for
- Major depressive disorder (MDD) in adults with inadequate response to other antidepressants
- Not for initial treatment, because of serious adverse reactions, drug interactions and the need for dietary restrictions
Dosing
- 30 mg per day in divided doses
- If response is inadequate, increase by 10 mg per day every 1 to 3 weeks to a maximum of 30 mg twice daily (60 mg per day); more gradually in patients at risk of hypotension (e.g. geriatric)
- Switching: after other MAOIs wait at least one week or 4 to 5 half-lives; after tranylcypromine wait at least one week before contraindicated antidepressants
- Taper slowly (withdrawal effects including delirium); screen for mania and measure blood pressure before starting
Contraindications
- Combination with other MAOIs, SSRIs, SNRIs, tricyclic and other antidepressants, amphetamines, methylphenidates, sympathomimetics and triptans
- Individual drugs such as buspirone, carbamazepine, dextromethorphan, levodopa, meperidine, tapentadol, tryptophan (full list: see the full text)
- Pheochromocytoma or other catecholamine-releasing paragangliomas
Important warnings
- Boxed warning: increased risk of suicidal thoughts and behaviors in pediatric and young adult patients; not approved for children
- Boxed warning: hypertensive crisis with tyramine-rich foods or beverages or certain drugs; monitor blood pressure
- Serotonin syndrome; activation of mania/hypomania; hypotension
- Discontinuation syndrome; hepatotoxicity; seizures; hypoglycemia in diabetes; impaired ability to drive
Side effects
- Most common (>30%): dry mouth, dizziness, insomnia, sedation, headache
- Over 10%: overexcitement, constipation, blurred vision, tremor
- Also hypertensive crisis, hypotension with syncope, tachycardia, blood dyscrasias, hepatitis
Interactions
- Numerous drugs contraindicated (serotonin syndrome or hypertensive crisis); over-the-counter medicines and supplements only after consulting a healthcare provider
- Avoid foods and beverages with high tyramine content
Pregnancy and breastfeeding
- Limited reports of placental infarction and congenital anomalies; advise of potential risk to a fetus
- Present in human milk; discontinue breastfeeding during treatment
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- Tranylcypromin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- JatrosomAristo Pharma Gmbh (Art 57) · 1 register entry
- Tranylcypromin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Tranylcypromin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
USA
- ParnateAdvanz Pharma (US) Corp. · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 8 more European countries
- Denmark
- Abbonate, Tranylcypromin Holsten, Tranylcypromine Holsten
- Finland
- Abbonate
- Iceland
- Abbonate
- Ireland
- Parnate, Tranylcypromine Eignapharma
- Netherlands
- Tracydal, Tranylcypromine Activase, Tranylcypromine Aristo, Tranylcypromine Double-E Pharma, Tranylcypromine Glenmark, Tranylcypromine Milstein
- Norway
- Abbonate, Tranylcypromine Afortas
- Spain
- Tranilcipromina Aristo
- Sweden
- Abbonate, Tranylcypromin Holsten, Tranylcypromine Afortas, Tranylcypromine Glenmark, Tranylcypromine Holsten
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Tranylcypromine Sulfate (Actavis Pharma, Inc.) – Prescribing Information, 2025-07-25. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6a0b609b-0625-4c26-91a1-59ee3ece3ddf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N06AF.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.