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)
Abdominal discomfort07.01.06.0010.000416%Not Available
Abdominal pain07.01.05.0020.000367%
Abdominal pain upper07.01.05.0030.000416%
Acute hepatic failure09.01.03.0010.000122%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.001--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.0010.000330%
Amyloidosis10.02.05.001--Not Available
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anuria20.01.03.002--Not Available
Anxiety19.06.02.002--
Aplastic anaemia01.03.03.002--Not Available
Areflexia17.02.01.001--Not Available
Arthralgia15.01.02.0010.000416%
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.001137%Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Axonal neuropathy17.09.03.015--Not Available
Azoospermia21.03.03.001--
Bladder pain20.02.02.001--Not Available
Blister23.03.01.001; 12.01.06.0020.000269%Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Cardiac arrest02.03.04.001--
Cardiac failure congestive02.05.01.0020.000122%Not Available
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