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Ergotamine

ATC code N02CA02

Also known as: Ergotamin, Ergomar Sublingual

Key facts
Active substance
Ergotamine
Drug class
Antimigraine
ATC code
N02CA02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONSand WARNINGSsection)

Key facts

Ergotamine is a vasoconstricting ergot alkaloid. Per the US prescribing information (Ergomar sublingual tablets), it is used to abort or prevent vascular headache such as migraine.

What it is used for

  • To abort or prevent vascular headache, e.g. migraine, migraine variants or so-called histaminic cephalalgia

Dosing

  • At the first sign of an attack, place one 2 mg tablet under the tongue; early administration gives maximum effectiveness
  • If necessary, another tablet at half-hour intervals, not exceeding three tablets in any 24 hour period
  • No more than five tablets (10 mg) in any one week; not for chronic daily administration

Contraindications

  • Coadministration of potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole)
  • Women who are or may become pregnant
  • Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, sepsis
  • Hypersensitivity to any component

Important warnings

  • Boxed warning: serious, life-threatening peripheral ischemia with potent CYP3A4 inhibitors such as protease inhibitors and macrolides; increased risk of cerebral or limb ischemia
  • Less potent CYP3A4 inhibitors (e.g. saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, metronidazole) also carry a potential risk
  • Fibrotic complications (retroperitoneal or pleuropulmonary fibrosis, valve thickening) with long-term use

Side effects

  • Serious vasoconstrictive complications: ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial pain, EKG changes, muscle pains
  • Transient tachycardia or bradycardia, hypertension
  • Nausea and vomiting; paresthesias, numbness, weakness, vertigo; localized edema and itching

Interactions

  • Potent CYP3A4 inhibitors: ergotism, contraindicated
  • Not with other vasoconstrictors; sympathomimetics may cause extreme blood pressure elevation
  • Propranolol may potentiate the vasoconstrictive action; nicotine may predispose to ischemia

Pregnancy and breastfeeding

  • Contraindicated in pregnancy (oxytocic effect, may cause fetal harm)
  • Excreted in breast milk and may cause vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants

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.

Full official text →

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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.

Germany

  • Ergo-Kranit MigräneFairmed Healthcare Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

USA

  • Ergomar SublingualPangea Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 2 more European countries
Hungary
Ergam
Poland
Ergotaminum Filofarm

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?

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Sources

  1. U.S. Food and Drug Administration. Ergomar Sublingual (Pangea Pharmaceuticals LLC) – Prescribing Information, 2025-02-25. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a9582fdb-7ddd-4f69-aa7a-66247cdb8c92
  2. 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
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  4. Wikidata (CC0): ATC N02CA.

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.