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 Alosetron was voluntarily withdrawn from the US market in November 2000 by the manufacturer due to numerous reports of severe adverse effects including ischemic colitis, severely obstructed or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 Prescription
ATC Code A03AE01
DrugBank ID DB00969
KEGG ID D07129
MeSH ID C090840
PubChem ID 2099
NDC Product Code 63629-2518; 70756-702; 70756-701; 63629-2517
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
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; Available
Acne23.02.01.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Bladder pain20.02.02.001--Not Available
Blood pressure increased13.14.03.005--Not Available
Bone pain15.02.01.001--
Burning sensation08.01.09.029; Available
Colitis ischaemic24.04.08.012; Available
Colitis ulcerative10.02.01.004; Available
Confusional state17.02.03.005;
Dermatitis23.03.04.002--Not Available
Dermatitis allergic23.03.04.003; Available
Dermatitis atopic23.03.04.016; Available
Discomfort08.01.08.003--Not Available
Diverticulitis11.01.07.003; Available
Drug interaction08.06.03.001--Not Available
Dry mouth07.06.01.002--
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