Is Colchicine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Colchicine.

Is Colchicine approved by the US FDA?

Drugs@FDA lists 23 application product lines for Colchicine, including COLCRYS (Prescription); COLCRYS (Prescription); MITIGARE (Prescription); COLCHICINE (Prescription); COLCHICINE (Prescription).

Is Colchicine authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Colchicine: Colchicine Agepha Pharma.

Are there safety signals or safety updates for Colchicine?

US FDA: 3 entries; MHRA: 1 entry (latest 2024-08-28).

Active substance

Colchicine

SFDA 2
US FDA 23
EMA 1
Health Canada 4
US price lines 4
NHS prices 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
COLMEDITEN TAB	0.5 mg	Tablet · Oral use	20 Blister	SAR 2.00	NCE · Prescription	KAHIRA EYGEPT	Withdrawn by MAH · Not Marketed
GOTINE 0.6MG TAB	0.6 mg	Tablet · Oral use	100 Blister	SAR 10.25	Generic · Prescription	WEST-WARD	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
COLCRYS	0.6MG	tablet · oral	AR HOLDING CO INC	Prescription	30 Jul 2009
COLCRYS	0.6MG	tablet · oral	AR HOLDING CO INC	Prescription	16 Oct 2009
MITIGARE	0.6MG	capsule · oral	HIKMA INTL PHARMS	Prescription	26 Sep 2014
COLCHICINE	0.6MG	tablet · oral	AMNEAL PHARMS	Prescription	28 Sep 2016
COLCHICINE	0.6MG	capsule · oral	PH HEALTH	Prescription	29 Nov 2018
GLOPERBA	0.6MG/5ML	solution · oral	SCILEX PHARMS	Prescription	30 Jan 2019
COLCHICINE	0.6MG	tablet · oral	ALKEM LABS LTD	Prescription	8 Feb 2019
COLCHICINE	0.6MG; 0.3MG	tablet · oral	ZYDUS PHARMS	Prescription	19 Feb 2019
COLCHICINE	0.6MG	tablet · oral	WATSON LABS INC	Prescription	31 Jul 2019
COLCHICINE	0.6MG	tablet · oral	DR REDDYS	Prescription	6 Sep 2019
COLCHICINE	0.6MG	tablet · oral	MYLAN	Prescription	16 Sep 2019
COLCHICINE	0.6MG	tablet · oral	GRANULES	Prescription	5 Feb 2020
COLCHICINE	0.6MG	tablet · oral	PH HEALTH	Prescription	12 Aug 2021
COLCHICINE	0.6MG	tablet · oral	HETERO LABS LTD V	Prescription	13 Aug 2021
COLCHICINE	0.6MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	6 Jan 2022
COLCHICINE	0.6MG	tablet · oral	STRIDES PHARMA	Prescription	10 Mar 2022
LODOCO	0.5MG	tablet · oral	AGEPHA PHARMA FZ	Prescription	16 Jun 2023
COLCHICINE	0.6MG	capsule · oral	GRANULES	Prescription	29 Apr 2024
COLCHICINE	0.6MG	capsule · oral	AUROBINDO PHARMA LTD	Prescription	29 Apr 2024
COLCHICINE	0.6MG	capsule · oral	ANNORA PHARMA	Prescription	29 Apr 2024
COLCHICINE	0.6MG	tablet · oral	MACLEODS PHARMS	Prescription	13 Feb 2026
COLCHICINE	0.6MG	capsule · oral	MICRO LABS	Prescription	17 Feb 2026
COLCRYS	0.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	TAKEDA PHARMS USA	Discontinued	29 Jul 2009

EMA European Union — centrally authorised medicines

Colchicine Agepha Pharma Agepha Pharma s.r.o. · Authorised · authorised 24 Jul 2026 · ATC M04AC01

Therapeutic indication (EMA)

Colchicine AGEPHA Pharma is indicated for secondary prevention of atherothrombotic events in adult patients with coronary disease stable for at least 6 months.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
COLCHICINE TAB 0.6MG	00572349	0.6 MG	TABLET · ORAL	ODAN LABORATORIESLTD
JAMP-COLCHICINE	02373823	0.6 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
MYINFLA	02519380	0.5 MG	TABLET (EXTENDED-RELEASE) · ORAL	PENDOPHARM DIVISION OF PHARMASCIENCE INC
PMS-COLCHICINE	02402181	0.6 MG	TABLET · ORAL	PHARMASCIENCE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	COLCHICINE 0.6 MG CAPSULE	$1.75282	per EA	23 Sep 2026
US NADAC	COLCHICINE 0.6 MG TABLET	$0.1221	per EA	23 Sep 2026
US NADAC	LODOCO 0.5 MG TABLET	$16.99949	per EA	29 Dec 2025
US NADAC	MITIGARE 0.6 MG CAPSULE	$6.02925	per EA	23 Sep 2026
NHS Drug Tariff	Colchicine 500microgram tablets	£1.53	100 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 28 Aug 2024 GLOPERBA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 May 2024 MITIGARE — safety-related labeling change
Labeling sections changed: Use in Specific Populations
US FDA 14 May 2020 COLCRYS — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 11 Dec 2014 Colchicine: extremely toxic in overdose
Reminder on risk of serious and fatal toxicity in overdose.

All safety entries for colchicine →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.