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 In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.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Marketing Status approved; illicit; investigational; withdrawn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)
Thirst08.01.09.021; 14.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytosis01.08.02.001--Not Available
Thyroid disorder05.02.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tongue disorder07.14.01.002--Not Available
Tongue oedema07.14.02.007; 23.04.01.009; 10.01.05.008--Not Available
Tooth abscess11.01.04.003; 07.09.01.003--Not Available
Tooth disorder07.09.05.001--Not Available
Torsade de pointes02.03.04.005--Not Available
Torticollis17.01.03.003; 15.05.04.003--Not Available
Tourette's disorder19.11.04.002; 17.19.02.001; 03.10.01.001--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Urinary incontinence20.02.02.010; 17.05.01.008--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Varicose vein24.10.04.001--Not Available
Vascular headache24.03.05.007; 17.14.01.005--Not Available
Vascular purpura24.07.06.011; 23.06.01.008; 01.01.04.007--Not Available
Vasculitic rash24.12.04.026; 23.06.02.003; 10.02.02.012--Not Available
Ventricular extrasystoles02.03.04.007--Not Available
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.010--
Vertigo17.02.12.002; 04.04.01.003--
Vestibular disorder17.02.02.008; 04.04.02.001--
Vision blurred17.17.01.010; 06.02.06.007--
Visual impairment06.02.10.013--Not Available
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