FDA — authorised 29 July 2009
- Application: NDA022352
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: COLCRYS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Colchicine 0.6 mg in United States
FDA authorised Colchicine 0.6 mg on 29 July 2009 · 53 US adverse-event reports
Marketing authorisations
FDA — authorised 30 July 2009
- Application: NDA022351
- Marketing authorisation holder: AR HOLDING CO INC
- Local brand name: COLCRYS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2009
- Application: NDA022353
- Marketing authorisation holder: AR HOLDING CO INC
- Local brand name: COLCRYS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2023
- Application: NDA215727
- Marketing authorisation holder: AGEPHA PHARMA FZ
- Local brand name: LODOCO
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 53
Most-reported reactions
- Diarrhoea — 11 reports (20.75%)
- Nausea — 9 reports (16.98%)
- Abdominal Pain — 5 reports (9.43%)
- Gout — 5 reports (9.43%)
- Pyrexia — 5 reports (9.43%)
- Hypoaesthesia — 4 reports (7.55%)
- Unresponsive To Stimuli — 4 reports (7.55%)
- Vomiting — 4 reports (7.55%)
- Alanine Aminotransferase Increased — 3 reports (5.66%)
- Arthralgia — 3 reports (5.66%)
Colchicine 0.6 mg in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Colchicine 0.6 mg approved in United States?
Yes. FDA authorised it on 29 July 2009; FDA authorised it on 30 July 2009; FDA authorised it on 16 October 2009.
Who is the marketing authorisation holder for Colchicine 0.6 mg in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.