Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Rofecoxib
Drug ID BADD_D01961
Description Rofecoxib is used for the treatment of osteoarthritis, rheumatoid arthritis, acute pain in adults, and primary dysmenorrhea, as well as acute treatment of migraine attacks with or without auras. Rofecoxib is a solid. This compound belongs to the stilbenes. These are organic compounds containing a 1,2-diphenylethylene moiety. Stilbenes (C6-C2-C6 ) are derived from the common phenylpropene (C6-C3) skeleton building block. The introduction of one or more hydroxyl groups to a phenyl ring lead to stilbenoids. Rofecoxib has a half-life of 17 hours and its mean oral bioavailability at therapeutically recommended doses of 125, 25, and 50 mg is approximately 93%. The proteins that rofecoxib target include elastin and prostaglandin G/H synthase 2. Cytochrome P450 1A2, Cytochrome P450 3A4, Cytochrome P450 2C9, Cytochrome P450 2C8, and Prostaglandin G/H synthase 1 are known to metabolize rofecoxib. On September 30, 2004, Merck voluntarily withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use.
Indications and Usage For the treatment of osteoarthritis, rheumatoid arthritis, acute pain in adults, and primary dysmenorrhea, as well as acute treatment of migraine attacks with or without auras.
Marketing Status approved; investigational; withdrawn
ATC Code M01AH02
DrugBank ID DB00533
KEGG ID D00568
MeSH ID C116926
PubChem ID 5090
TTD Drug ID D05VLS
NDC Product Code Not Available
UNII 0QTW8Z7MCR
Synonyms rofecoxib | refecoxib | Vioxx | Vioxx Dolor | MK 0966 | MK 966 | MK-966 | MK-0966
Chemical Information
Molecular Formula C17H14O4S
CAS Registry Number 162011-90-7
SMILES CS(=O)(=O)C1=CC=C(C=C1)C2=C(C(=O)OC2)C3=CC=CC=C3
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)
Epistaxis22.04.03.001; 24.07.01.005--
Erythema23.03.06.001---
Erythema multiforme10.01.03.015; 23.03.01.003--
Eye disorder06.08.03.001---
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Feeling abnormal08.01.09.014---
Flatulence07.01.04.002--
Fluid retention14.05.06.002; 20.01.02.003---
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Fungal infection11.03.05.001---
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.016--
Gastric perforation07.04.03.001; 12.02.03.007--
Gastric ulcer07.04.03.002--
Gastric ulcer perforation07.04.03.006---
Gastritis07.08.02.001--
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastroenteritis viral07.19.03.005; 11.05.04.005---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Haematochezia07.12.02.003; 24.07.02.012---
Haematoma24.07.01.001--
Haemorrhoids07.15.03.001; 24.10.02.002--
Hallucination19.10.04.003--
Headache17.14.01.001--
Heart rate irregular13.14.04.003---
Hepatic failure09.01.03.002--
Hepatitis09.01.07.004---
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