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 In October 2010, Sibutramine was withdrawn from Canadian and U.S. markets due to concerns that the drug increases the risk of heart attack and stroke in patients with a history of heart disease.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Marketing Status approved; illicit; investigational; withdrawn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)
Mood altered19.04.02.007--Not Available
Mouth ulceration07.05.06.004--Not Available
Muscle spasms15.05.03.004--
Muscle twitching15.05.03.005--Not Available
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nasal congestion22.04.04.001--
Nausea07.01.07.001--
Neck pain15.03.04.009--
Nervousness19.06.02.003--Not Available
Nightmare19.02.03.003--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Osteoarthritis15.01.04.001--Not Available
Otitis externa11.01.05.003; 04.01.02.001--
Otitis media11.01.05.004; 04.05.01.001--
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Petechiae24.07.06.004; 23.06.01.003; 01.01.03.002--Not Available
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Photophobia17.17.02.006; 06.01.01.004--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Respiratory disorder22.02.07.002--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Salivary hypersecretion07.06.01.009--Not Available
Seizure17.12.03.001--
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