Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Alosetron hydrochloride
Drug ID BADD_D00083
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 Alosetron was voluntarily withdrawn from the US market in November 2000 by the manufacturer due to numerous reports of severe adverse effects including ischemic colitis, severely obstructed or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Marketing Status approved; withdrawn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 D02829
MeSH ID C090840
PubChem ID 60758
TTD Drug ID D06GKN
NDC Product Code 76055-0009; 64980-453; 64980-454; 54766-894; 45963-480; 65162-248; 0054-0295; 0054-0296; 58159-032; 45963-479; 49884-819; 65162-249; 53104-7658; 49884-820; 54766-895
UNII 2F5R1A46YW
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 C17H19ClN4O
CAS Registry Number 122852-69-1
SMILES CC1=C(N=CN1)CN2CCC3=C(C2=O)C4=CC=CC=C4N3C.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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; 17.15.02.001--Not Available
Acne23.02.01.001--Not Available
Alopecia23.02.02.001--
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Blood pressure increased13.14.03.005--Not Available
Bone pain15.02.01.001--
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Calcium metabolism disorder14.04.01.002--Not Available
Cholecystitis09.03.01.001--
Colitis07.08.01.001--
Colitis ischaemic24.04.08.012; 07.08.01.004--Not Available
Colitis ulcerative07.08.01.005; 10.02.01.004--Not Available
Confusional state19.13.01.001; 17.02.03.005--
Constipation07.02.02.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis allergic23.03.04.003; 10.01.03.014--Not Available
Diarrhoea07.02.01.001--
Diverticulitis11.01.07.003; 07.10.02.001--Not Available
Dry mouth07.06.01.002--
Dysgeusia07.14.03.001; 17.02.07.003--
Dyspepsia07.01.02.001--
Ear infection11.01.05.001; 04.03.01.006--Not Available
Eczema23.03.04.006--
Extrasystoles02.03.02.003--Not Available
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