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 In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.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Marketing Status approved; illicit; investigational; withdrawn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)
Neurosis19.06.01.001--Not Available
Nightmare19.02.03.003--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Oesophagitis07.08.05.001--
Orthostatic hypotension24.06.03.004; 17.05.01.020--Not Available
Osteoarthritis15.01.04.001--Not Available
Osteoporosis15.02.03.002; 14.04.04.002--
Otitis externa11.01.05.003; 04.01.02.001--
Otitis media11.01.05.004; 04.05.01.001--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Parosmia22.04.03.007; 17.04.04.002--Not Available
Pelvic pain07.01.06.012; 21.10.01.001; 20.02.03.007--
Peripheral vascular disorder24.03.01.003--Not Available
Personality disorder19.05.02.002--Not Available
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Pharyngitis11.01.13.003; 07.05.07.004; 22.07.03.004--
Phlebitis24.12.03.004; 12.02.01.002--
Photosensitivity reaction23.03.09.003--
Pneumonia22.07.01.003; 11.01.09.003--Not Available
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Psoriasis23.03.14.002; 10.02.01.036--Not Available
Purpura24.07.06.005; 23.06.01.004; 01.01.04.003--
Rash23.03.13.001--Not Available
Rash macular23.03.13.003--Not Available
Rash pustular23.03.10.003; 11.01.12.002--
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