Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Sibutramine hydrochloride
Drug ID BADD_D02017
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 In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.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Marketing Status approved; illicit; investigational; withdrawn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 D02571
MeSH ID C058254
PubChem ID 64764
TTD Drug ID D08KVZ
NDC Product Code Not Available
UNII OGM0YHD1WF
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 C17H27Cl2N
CAS Registry Number 84485-00-7
SMILES CC(C)CC(C1(CCC1)C2=CC=C(C=C2)Cl)N(C)C.Cl
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)
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Generalised oedema14.05.06.007; 08.01.07.004--
Goitre14.11.01.008; 05.02.01.001--Not Available
Haematuria24.07.01.047; 20.02.01.006; 21.10.01.018--
Headache17.14.01.001--
Heart rate decreased13.14.04.001--Not Available
Herpes simplex23.11.05.004; 11.05.02.001--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hyperthyroidism14.11.01.011; 05.02.02.001--
Hypertonia17.05.02.001; 15.05.04.007--Not Available
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Hypoglycaemia14.06.03.001; 05.06.03.001--
Hypothyroidism14.11.01.012; 05.02.03.001--
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Influenza11.05.03.001; 22.07.02.001--Not Available
Injury12.01.08.004--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Intestinal obstruction07.13.01.002--Not Available
Intraocular pressure increased13.07.04.002--Not Available
Laryngitis11.01.13.001; 22.07.03.001--
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased21.03.02.007; 19.08.03.002--
Lymphadenopathy01.09.01.002--Not Available
Mania19.16.02.002--
Menstrual disorder21.01.01.004--Not Available
Migraine24.03.05.003; 17.14.02.001--Not Available
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