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 Febuxostat is indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of [allopurinol], who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. It is not recommended for the treatment of asymptomatic hyperuricemia [L32238] or secondary hyperuricemia.[A230583]
Marketing Status approved
ATC Code M04AA03
DrugBank ID DB04854
KEGG ID D01206
MeSH ID D000069465
PubChem ID 134018
TTD Drug ID D0A5SE
NDC Product Code 64220-162; 16714-060; 55154-5159; 72578-137; 49587-112; 27808-206; 27808-207; 60687-538; 64764-918; 0527-2248; 55111-796; 69539-035; 69539-036; 72205-029; 42765-021; 50379-0021; 65015-820; 65372-1189; 16714-059; 43547-296; 47335-722; 62332-190; 59651-103; 64764-677; 0378-3925; 72205-028; 72578-136; 55111-935; 64552-4045; 65977-0134; 76397-003; 62332-191; 0054-0414; 71610-411; 71610-450; 14445-011; 82245-0103; 14445-157; 46708-191; 55111-797; 67877-668; 0054-0413; 0527-2244; 70771-1553; 55154-5158; 11722-061; 50379-0003; 43547-295; 46708-190; 47335-721; 67877-669; 68071-5271; 70771-1552; 14445-156; 51407-293; 51407-294
UNII 101V0R1N2E
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
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 discomfort07.01.06.0010.013406%Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Activated partial thromboplastin time prolonged13.01.02.001--
Acute myocardial infarction24.04.04.001; 02.02.02.0010.005633%Not Available
Ageusia17.02.07.001; 07.14.03.0030.001014%Not Available
Agitation19.06.02.001; 17.02.05.012--
Alopecia23.02.02.001--
Amylase increased13.05.01.009--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.002065%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.0010.001765%Not Available
Arteriosclerosis24.04.02.0010.000563%Not Available
Arthralgia15.01.02.0010.020541%
Arthritis15.01.01.001--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.002328%
Atrial flutter02.03.03.0030.000563%
Blister23.03.01.001; 12.01.06.002--Not Available
Blood bicarbonate decreased13.02.01.035--
Blood cholesterol increased13.12.01.002--
Blood creatine increased13.13.01.001--Not Available
Blood creatine phosphokinase increased13.04.01.001--
Blood creatinine increased13.13.01.004--
Blood glucose increased13.02.02.002--Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood potassium increased13.11.01.011--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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