Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Colchicine
Drug ID BADD_D00518
Description First approved by the FDA in 1961, colchicine is an alkaloid drug commonly used in the management of gout, a condition associated with the painful deposition of urate crystals in the joints.[A183614,L8138] It is derived from a plant belonging to the Lily family, known as Colchicum autumnale, or "autumn crocus".[A183611] Other than its use in gout, colchicine has been approved for managing exacerbations of Familial Mediterranean Fever (FMF), a hereditary autoinflammatory condition.[A186320,L8141]
Indications and Usage Colchicine is indicated for the prophylaxis and treatment of gout flares. It is also indicated in Familial Mediterranean fever (FMF) in children and adults of 4 years of age and older. It is important to note that this medication is not a pain reliever to be used for other painful conditions. Consider analgesics for this purpose.[L8138] Some off-label uses of colchicine include the treatment of the manifestations of Behcet's syndrome, pericarditis, and postpericardiotomy syndrome.[A183932,A183935]
Marketing Status approved
ATC Code M04AC01
DrugBank ID DB01394
KEGG ID D00570
MeSH ID D003078
PubChem ID 6167
TTD Drug ID D09DHY
NDC Product Code 0904-6732; 72643-009; 59467-318; 59651-455; 65162-710; 69037-0011; 0254-2008; 0378-1086; 51927-0277; 31722-899; 51407-082; 63187-292; 63629-7422; 63629-8362; 72189-249; 72189-331; 60687-389; 60687-727; 63629-2166; 67877-589; 70771-1590; 71205-310; 47234-0119; 50268-187; 64764-119; 70710-1571; 0591-2562; 71610-494; 75854-801; 61281-3600; 68404-0001; 23155-855; 64380-796; 70771-1396; 71335-1802; 0904-7120; 55742-127; 16714-039; 70010-002; 71205-687; 71335-1738; 63629-8766; 17359-5000; 66064-1008; 71335-1695; 43598-372; 49884-171; 50090-3465; 60687-358; 63629-2167; 70710-1351; 0143-3018; 42292-054
UNII SML2Y3J35T
Synonyms Colchicine | Colchicine, (R)-Isomer | Colchicine, (+-)-Isomer
Chemical Information
Molecular Formula C22H25NO6
CAS Registry Number 64-86-8
SMILES CC(=O)NC1CCC2=CC(=C(C(=C2C3=CC=C(C(=O)C=C13)OC)OC)OC)OC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Swelling08.01.03.0150.000122%Not Available
Tachycardia02.03.02.0070.000183%Not Available
Tachypnoea22.02.01.0140.000122%Not Available
Therapeutic response decreased08.06.01.0160.000122%Not Available
Thrombocytopenia01.08.01.0020.000269%Not Available
Unresponsive to stimuli17.02.05.031--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Vomiting07.01.07.0030.000513%
Peripheral swelling08.01.03.053; 02.05.04.0150.000416%Not Available
Brain oedema17.07.02.003; 12.01.10.010--
Bladder spasm20.02.02.013--
Central nervous system lesion17.02.10.011--Not Available
Ocular discomfort06.08.03.008--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Growth retardation15.03.05.016; 14.03.02.031; 05.03.02.007--
Purpura non-thrombocytopenic01.01.04.006--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Limb discomfort15.03.04.014--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.0020.000122%Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Myotonia17.05.02.013; 15.05.04.013--Not Available
Blood disorder01.05.01.004--Not Available
Drug intolerance08.06.01.0130.000416%Not Available
Renal impairment20.01.03.010--Not Available
Autism spectrum disorder17.03.05.003; 19.22.02.002--Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.004--
Bone marrow failure01.03.03.005--
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