Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Cerivastatin
Drug ID BADD_D00415
Description On August 8, 2001 the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceutical Division voluntarily withdrew Baycol from the U.S. market, due to reports of fatal Rhabdomyolysis, a severe adverse reaction from this cholesterol-lowering (lipid-lowering) product. It has also been withdrawn from the Canadian market.
Indications and Usage Used as an adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate.
Marketing Status approved; withdrawn
ATC Code C10AA06
DrugBank ID DB00439
KEGG ID D07661
MeSH ID C086276
PubChem ID 446156
TTD Drug ID D03KIA
NDC Product Code Not Available
UNII AM91H2KS67
Synonyms cerivastatin | Kazak | cerivastatin sodium | 6-Heptenoic acid, 7-(4-(4-fluorophenyl)-5-(methoxymethyl)-2,6-bis(1-methylethyl)-3-pyridinyl)-3,5-dihydroxy-, monosodium salt, (S-(R*,S*-(E)))- | 7-(4-(4-fluorophenyl)-2,6-diisopropyl-5-(methoxymethyl)pyrid-3-yl)-3,5-dihydroxy-6-heptenoate sodium salt | rivastatin | Certa | Bay w 6228 | Baycol | Lipobay
Chemical Information
Molecular Formula C26H34FNO5
CAS Registry Number 145599-86-6
SMILES CC(C)C1=C(C(=C(C(=N1)C(C)C)COC)C2=CC=C(C=C2)F)C=CC(CC(CC(=O)O)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)
Renal failure20.01.03.005--Not Available
Rhabdomyolysis15.05.05.002--
Rhinitis22.07.03.006; 11.01.13.004--
Sinusitis22.07.03.007; 11.01.13.005--
Somnolence19.02.05.003; 17.02.04.006--
Stevens-Johnson syndrome10.01.01.045; 23.03.01.007; 12.03.01.014; 11.07.01.005--
Systemic lupus erythematosus23.03.02.006; 10.04.03.004; 15.06.02.003--Not Available
Thrombocytopenia01.08.01.002--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Tremor17.01.06.002--
Urticaria23.04.02.001; 10.01.06.001--
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Vasculitis24.12.04.027; 10.02.02.006--
Vertigo17.02.12.002; 04.04.01.003--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Facial paresis17.04.03.002--
Musculoskeletal discomfort15.03.04.001--Not Available
Nodule08.03.05.002--Not Available
Transaminases increased13.03.04.036--Not Available
Peripheral nerve palsy17.01.04.017--Not Available
Antinuclear antibody positive13.06.01.003--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Renal impairment20.01.03.010--Not Available
Acute kidney injury20.01.03.016--
Hepatic cancer16.07.02.004; 09.04.02.008--Not Available
Hepatocellular carcinoma16.07.02.005; 09.04.02.010--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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