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 Discontinued
ATC Code M01AH02
DrugBank ID DB00533
KEGG ID D00568
MeSH ID C116926
PubChem ID 5090
TTD Drug ID D05VLS
NDC Product Code 62704-0056
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
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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abdominal tenderness07.01.05.004--Not Available
Abscess11.01.08.001--Not Available
Agranulocytosis01.02.03.001--Not Available
Alopecia23.02.02.001--
Alveolitis22.01.01.001--Not Available
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Aphthous ulcer07.05.06.002--Not Available
Aplastic anaemia01.03.03.002--Not Available
Arthralgia15.01.02.001--
Arthropod bite12.01.08.022--Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Basal cell carcinoma23.08.02.001; 16.03.02.001--Not Available
Bladder pain20.02.02.001--Not Available
Blister23.03.01.001; 12.01.06.002--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Breast mass21.05.04.002--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
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