Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alosetron
Drug ID BADD_D00082
Description Alosetron is a 5-HT3 antagonist used only for the management of severe diarrhoea-predominant irritable bowel syndrome (IBS) in women. Alosetron has an antagonist action on the 5-HT3 receptors and thus may modulate serotonin-sensitive gastrointestinal (GI) processes. Alosetron was voluntarily withdrawn from the US market in November 2000 by the manufacturer due to numerous reports of severe adverse effects including ischemic colitis, severely obstructed or ruptured bowel, and death. In June 2002, the FDA approved a supplemental new drug application allowing the remarketing of the drug under restricted conditions of use.
Indications and Usage Only for the treatment of symptoms of severe diarrhea-predominant irritable bowel syndrome (IBS) in women with chronic symptoms (generally lasting greater than 6 months) who does not present with anatomic or biochemical GI abnormalities and have not responded to conventional therapy.
Marketing Status approved; withdrawn
ATC Code A03AE01
DrugBank ID DB00969
KEGG ID D07129
MeSH ID C090840
PubChem ID 2099
TTD Drug ID D06GKN
NDC Product Code 63629-2517; 63629-2518; 70756-701; 70756-702
UNII 13Z9HTH115
Synonyms alosetron | Lotronex | alosetron hydrochloride | alosetron monohydrochloride | 2,3,4,5-tetrahydro-5-methyl-2-((5-methylimidazol-4-yl)methyl)-1H-pyrido(4,3-b)indol-1-one monohydrochloride | GR 68755 | GR68755
Chemical Information
Molecular Formula C17H18N4O
CAS Registry Number 122852-42-0
SMILES CC1=C(N=CN1)CN2CCC3=C(C2=O)C4=CC=CC=C4N3C
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)
Intussusception07.13.01.008--Not Available
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Laryngitis22.07.03.001; 11.01.13.001--
Malaise08.01.01.003--
Menstrual disorder21.01.01.004--Not Available
Muscle rigidity17.05.02.005; 15.05.04.001--Not Available
Muscle spasms15.05.03.004--
Myalgia15.05.02.001--
Nail disorder23.02.05.002--
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nausea07.01.07.001--
Pain08.01.08.004--
Photophobia17.17.02.006; 06.01.01.004--
Pollakiuria20.02.02.007--
Polyuria20.02.03.002--Not Available
Proctitis07.08.04.001--
Rash23.03.13.001--Not Available
Respiration abnormal22.02.01.041--Not Available
Respiratory disorder22.02.07.002--Not Available
Rhinitis allergic22.04.04.003; 10.01.04.003--
Sinusitis22.07.03.007; 11.01.13.005--
Skin disorder23.03.03.007--Not Available
Skin infection23.11.04.007; 11.01.12.003--
Sleep disorder19.02.04.001--Not Available
Tenderness08.01.08.005--Not Available
Tremor17.01.06.002--
Ulcer08.03.06.001--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
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ADReCS-Target
Drug Name ADR Term Target
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