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Marketing Status approved; investigational; withdrawn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)
Pelvic pain21.10.01.001; 20.02.03.007; 07.01.06.012--
Pharyngitis07.05.07.004; 22.07.03.004; 11.01.13.003--
Photosensitivity reaction23.03.09.003--
Pleural effusion22.05.02.002--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pruritus23.03.12.001--
Pseudoporphyria23.03.01.006--Not Available
Pulmonary congestion24.03.08.001; 22.01.03.002; 02.05.02.002--Not Available
Pulmonary embolism24.01.06.001; 22.06.02.001--Not Available
Pulmonary oedema22.01.03.003; 02.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Respiratory disorder22.02.07.002--Not Available
Retinal haemorrhage24.07.05.003; 06.10.01.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Rhinitis allergic22.04.04.003; 10.01.04.003--
Sciatica15.10.01.001; 17.10.03.001--Not Available
Seizure17.12.03.001--
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.003--Not Available
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Stomatitis07.05.06.005--
Suicide attempt19.12.01.004--
Syncope02.11.04.015; 24.06.02.012; 17.02.04.008--
Tachycardia02.03.02.007--Not Available
Tendonitis15.07.01.003; 12.01.07.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
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