Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Febuxostat
Drug ID BADD_D00870
Description Febuxostat is a non-purine xanthine oxidase (XO) inhibitor.[A39743] In early 2008, febuxostat was granted marketing authorization by the European Commission for the treatment of chronic hyperuricemia and gout.[A230548] In the following year, the FDA for approved febuxostat for use in the chronic management of hyperuricemia in adult patients with gout who have an inadequate response or intolerance to [allopurinol].[L32238] Gout is a form of arthritis that is caused by the accumulation of uric acid crystal in or around a joint, leading to inflammation and further deposition of uric acid crystal deposition in bones, joints, tissues, and other organs in the long term. Gout is closely associated with hyperuricemia. Febuxostat works by inhibiting the activity of an enzyme that is responsible for the synthesis of uric acid, thereby reducing serum uric acid levels.[A230548] In February 2019, a black box warning for febuxostat was added, based on the findings of a post-market clinical study (the CARES trial) where there was an increased risk of cardiovascular (CV) fatal outcomes in patients with gout and known cardiovascular disease treated with febuxostat, when compared to those treated with allopurinol. The manufacturer and the FDA advise health professionals to limit the use of febuxostat to second-line therapy in patients who have inadequate response or intolerance to allopurinol, and to avoid the use of febuxostat in patients with cardiovascular diseases.[A2742, L13056]
Indications and Usage For the treatment of hyperuricemia in patients with gout.
Marketing Status Prescription
ATC Code M04AA03
DrugBank ID DB04854
KEGG ID D01206
MeSH ID D000069465
PubChem ID 134018
TTD Drug ID D0A5SE
NDC Product Code 59651-103; 71610-411; 46708-190; 55111-935; 47335-722; 47335-721; 68071-5271; 55111-797; 0378-3926; 43353-305; 42672-0300; 50379-0003; 71610-386; 14445-157; 64552-4045; 55154-5159; 55111-796; 65372-1189; 46708-833; 60687-538; 49587-112; 0527-2244; 67877-669; 65015-820; 0054-0414; 51407-294; 71610-585; 62756-010; 14445-011; 16714-060; 27808-207; 55154-5158; 50379-0021; 67877-668; 69539-035; 76397-003; 0527-2248; 51407-293; 64220-162; 69539-036; 72205-028; 71610-450; 64764-918; 72205-029; 42765-021; 64764-677; 11722-061; 65977-0134; 0378-3925; 14445-156; 62332-190; 46708-191; 27808-206; 16714-059; 62332-191; 82245-0103; 0054-0413
Synonyms Febuxostat | TEI 6720 | 6720, TEI | TEI-6720 | TEI6720 | Uloric | 2-(3-cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylic acid
Chemical Information
Molecular Formula C16H16N2O3S
CAS Registry Number 144060-53-7
SMILES CC1=C(SC(=N1)C2=CC(=C(C=C2)OCC(C)C)C#N)C(=O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Eosinophil count increased13.01.06.0040.002582%Not Available
Eosinophilia01.02.04.001--
Epistaxis24.07.01.005; 22.04.03.001--
Erythema23.03.06.001--Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.003--Not Available
Faeces discoloured07.01.03.0020.001721%Not Available
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014--Not Available
Flatulence07.01.04.002--
Flushing23.06.05.003; 08.01.03.025; 24.03.01.002--
Frequent bowel movements07.02.04.002--Not Available
Gait disturbance17.02.05.016; 08.01.02.002--
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal disorder07.11.01.0010.005163%Not Available
Gastrointestinal pain07.01.05.005--
Gingival pain07.09.04.001--
Glomerular filtration rate decreased13.13.01.0090.006024%Not Available
Gout15.01.06.001; 14.09.01.0010.080892%Not Available
Gouty tophus14.09.01.005; 23.07.04.010; 15.01.06.0050.007745%Not Available
Guillain-Barre syndrome17.09.01.001; 11.07.01.001; 10.04.10.005--
Gynaecomastia21.05.04.003; 05.05.02.003--
Haematemesis24.07.02.011; 07.12.02.002--Not Available
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Haematocrit decreased13.01.05.001--Not Available
Haematuria24.07.01.047; 20.02.01.006--
Haemoglobin decreased13.01.05.003--Not Available
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.001721%Not Available
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