Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Sibutramine
Drug ID BADD_D02016
Description Sibutramine (trade name Meridia in the USA, Reductil in Europe and other countries), usually as sibutramide hydrochloride monohydrate, is an orally administered agent for the treatment of obesity. It is a centrally acting stimulant chemically related to amphetamines thus it is classified as a Schedule IV controlled substance in the United States. In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.
Indications and Usage For the treatment of obesity.
Marketing Status approved; illicit; investigational; withdrawn
ATC Code A08AA10
DrugBank ID DB01105
KEGG ID D08513
MeSH ID C058254
PubChem ID 5210
TTD Drug ID D08KVZ
NDC Product Code Not Available
UNII WV5EC51866
Synonyms sibutramine | di-desmethylsibutramine | didesmethylsibutramine | (R)-DDMS | Reductil | mono-desmethylsibutramine | sibutramine hydrochloride | N-1-(1-(4-chlorophenyl)cyclobutyl)-3-methylbutyl-N,N-dimethylamine HCl | BTS 54 524 | BTS-54524 | BTS 54524 | Meridia
Chemical Information
Molecular Formula C17H26ClN
CAS Registry Number 106650-56-0
SMILES CC(C)CC(C1(CCC1)C2=CC=C(C=C2)Cl)N(C)C
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)
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Yawning22.12.03.037--Not Available
Tubulointerstitial nephritis20.05.02.002--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Affect lability19.04.01.001--Not Available
Haemorrhage24.07.01.002--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
Major depression19.15.01.003--Not Available
Vasodilation procedure25.03.01.001--Not Available
Disturbance in sexual arousal19.08.04.003--Not Available
Angiopathy24.03.02.007--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Brain neoplasm17.20.01.003; 16.30.01.003--Not Available
Hormone level abnormal13.10.10.001--Not Available
Inflammation10.02.01.089; 08.01.05.007--Not Available
Malnutrition14.03.02.004--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
Lacrimal disorder06.08.02.005--Not Available
Psychotic disorder19.03.01.002--
Hyperlipidaemia14.08.03.001--
Renal impairment20.01.03.010--Not Available
Cystitis noninfective20.03.02.001--
Nephritic syndrome20.05.01.006--Not Available
Skin mass23.07.04.014--Not Available
Lacrimal structural disorder06.06.04.013--Not Available
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