Colchicine
Colchanova, Colchicin Agepha, Colchicin Bürger, Colchicin Ysat · ATC code M04AC01
Also known as: Colchicin, kolşisin · Brand names: Colchanova, Colchicin Agepha, Colchicin Bürger, Colchicin Ysat, Colctab, Colchicin Al, Colchicin Aliud, Colchicin Aspire Pharma, Colchicin Heumann, Colchicin Ratiopharm, Colchicin Stada, Colchicin Ysat Tiofarma, Colchicin Zentiva, Colxi, Colchicum Dispert …
- Key facts
- Active substance
- Colchicine
- Drug class
- Antigout agent
- ATC code
- M04AC01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Colchicine is an anti-gout agent. Per the US label, the tablets are used to prevent and treat acute gout flares and to treat familial Mediterranean fever (FMF).
What it is used for
- Prophylaxis of gout flares
- Treatment of acute gout flares at the first sign of a flare
- Familial Mediterranean fever in adults and children four years or older
Dosing
- Gout prophylaxis (adults and adolescents older than 16 years): 0.6 mg once or twice daily, maximum 1.2 mg/day
- Gout flare: 1.2 mg at the first sign, then 0.6 mg one hour later; maximum 1.8 mg over a 1-hour period
- FMF adults: 1.2 mg to 2.4 mg daily, adjusted in increments of 0.3 mg/day
- FMF children: 4 to 6 years 0.3 mg to 1.8 mg, 6 to 12 years 0.9 mg to 1.8 mg, older than 12 years 1.2 mg to 2.4 mg daily
- Dose depends on age, renal and hepatic function and co-administered drugs; adjustments in the full text
- Not an analgesic; taken without regard to meals
Contraindications
- Renal or hepatic impairment together with P-gp or strong CYP3A4 inhibitors (including all protease inhibitors except fosamprenavir)
Important warnings
- Fatal overdoses in adults and children; keep out of reach of children
- Blood dyscrasias such as myelosuppression, leukopenia, thrombocytopenia and aplastic anemia
- Life-threatening interactions with P-gp and strong CYP3A4 inhibitors
- Neuromuscular toxicity and rhabdomyolysis, especially with renal dysfunction, in the elderly and with statins, fibrates or cyclosporine
Side effects
- Gout prophylaxis: diarrhea most common
- Gout flares: diarrhea (23%) and pharyngolaryngeal pain (3%)
- FMF: gastrointestinal effects (cramping, nausea, diarrhea, abdominal pain, vomiting) in up to 20%; if severe they may herald more significant toxicity
Interactions
- P-gp and CYP3A4 inhibitors increase colchicine levels; fatal interactions reported, dose reduction or interruption may be needed
- Statins, fibrates and cyclosporine may potentiate myopathy
Pregnancy and breastfeeding
- Published data have not identified a drug-associated risk of major birth defects or miscarriage; colchicine crosses the placenta
- Colchicine is present in human milk; adverse events in breastfed infants have not been reported
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Patient information (US)
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
- ColchanovaPharmaselect International Beteiligungs Gmbh · 2 register entries
- Colchicin AgephaAgepha Pharma S.R.O · 1 register entry
- Colchicin BürgerJohannes Bürger Ysatfabrik Gmbh · 1 register entry
- Colchicin YsatTiofarma B.V. · 1 register entry
- ColctabKwizda Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- ColchanovaPharmaselect International Beteiligungs Gmbh · 1 register entry
- Colchicin AlAliud Pharma Gmbh · 1 register entry
- Colchicin AliudAliud Pharma Gmbh · 1 register entry
- Colchicin Aspire PharmaAspire Pharma (Malta) Limited · 1 register entry
- Colchicin BürgerJohannes Bürger Ysatfabrik Gmbh · 1 register entry
- Colchicin HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Colchicin RatiopharmRatiopharm Gmbh · 1 register entry
- Colchicin StadaStadapharm Gmbh · 1 register entry
- Colchicin Ysat TiofarmaTiofarma B.V. · 1 register entry
- Colchicin ZentivaZentiva Pharma Gmbh · 1 register entry
- ColxiPharmascience International Ltd · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- Colchicum DispertRECORDATİ İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- ColxerisSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- KolsinMENARİNİ SAĞLIK VE İLAÇ SAN. TİC. A.Ş. · 1 register entry
- KolsitekFARMA-TEK İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- Colcrys1 register entry
- GloperbaScilex Pharmaceuticals Inc. · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 23 more European countries
- Belgium
- Colchicin, Colchicine Opocalcium, Colchicine Tiofarma
- Bulgaria
- Clopasa, Colchanova, Colchicum-Dispert, Колктаб, Колхизен, Колхицин Екофарм, Стронакс
- Croatia
- Colcamexx, Colymbo
- Cyprus
- Colchicina Acarpia, Colchicine Iasis, Colchicine Renata, Colchicine Tiofarma
- Czechia
- Colchicine Indoco
- Denmark
- Colchicin Strides, Colchicin Tiofarma, Colrefuz
- Finland
- Colrefuz
- France
- Colchicine Opocalcium, Migoutine
- Greece
- Colchicin, Colchicina Acarpia, Colchicine Farmasyn, Colchicine Iasis
- Hungary
- Colcamexx, Colchicum-Dispert
- Iceland
- Colchicine Tiofarma, Colrefuz
- Ireland
- Colchicine Halewood, Colchicine Indoco, Colchicine Renata Pharmaceuticals (Ireland), Colchicine Tiofarma
- Italy
- Colchicina Lirca
- Luxembourg
- Colchicine Opocalcium Mayoly Benelux, Colchicine Tiofarma
- Malta
- Colchicine Aspire, Colchicine Aurobindo, Colchicine Renata (Uk), Colchicine Ria Generics, Colchicine Tiofarma
- Netherlands
- Colchicine Auro, Colchicine Cf, Colchicine Dmb, Colchicine Indoco, Colchicine Mylan, Colchicine Ria, Colchicine Sandoz, Colchicine Strides, Colchicine Teva, Colchicine Tiofarma, Gloricard
- Norway
- Colchicine Strides, Colrefuz, Kolkisin Tiofarma
- Poland
- Colchianova, Colchican, Colchicum Dispert, Dolcur
- Portugal
- Colchicine, Colquicina Tiofarma
- Romania
- Colchicina, Colchicină Iasis, Colchicină Pharmaselect
- Slovakia
- Colcamedin, Colchicine Iasis, Colchicine Indoco, Colchicum-Dispert
- Spain
- Colchicina
- Sweden
- Colrefuz, Kolkicin Strides, Kolkicin Tiofarma
EMA – Article 57 product data (EU/EEA), 2026-10-28
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. Colchicine (Chartwell RX, LLC) – Prescribing Information, 2025-12-10. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=16d8e0f4-567d-4de1-ac25-6e2527f1d58e
- EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC M04AC.
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.