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 It has also been withdrawn from the Canadian market.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Marketing Status approved; withdrawn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---
Rhabdomyolysis15.05.05.002--
Rhinitis11.01.13.004; 22.07.03.006--
Sinusitis11.01.13.005; 22.07.03.007--
Somnolence17.02.04.006; 19.02.05.003--
Stevens-Johnson syndrome10.01.01.045; 11.07.01.005; 12.03.01.014; 23.03.01.007--
Systemic lupus erythematosus10.04.03.004; 15.06.02.003; 23.03.02.006---
Thrombocytopenia01.08.01.002---
Toxic epidermal necrolysis10.01.01.006; 11.07.01.006; 12.03.01.015; 23.03.01.008--
Tremor17.01.06.002--
Urticaria10.01.06.001; 23.04.02.001--
Vascular purpura01.01.04.007; 23.06.01.008; 24.07.06.011---
Vasculitis10.02.02.006; 24.12.04.027--
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred06.02.06.007; 17.17.01.010--
Visual impairment06.02.10.013---
Vomiting07.01.07.003--
Facial paresis17.04.03.002--
Musculoskeletal discomfort15.03.04.001---
Nodule08.03.05.002---
Transaminases increased13.03.04.036---
Peripheral nerve palsy17.01.04.017---
Antinuclear antibody positive13.06.01.003---
Decreased appetite08.01.09.028; 14.03.01.005--
Erectile dysfunction19.08.04.001; 21.03.01.007--
Ill-defined disorder08.01.03.049---
Renal impairment20.01.03.010---
Acute kidney injury20.01.03.016--
Hepatic cancer09.04.02.008; 16.07.02.004---
Hepatocellular carcinoma09.04.02.010; 16.07.02.005---
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ADReCS-Target
Drug Name ADR Term Target
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