Last reviewed 2026-04-20 · How we verify

ALOSETRON HYDROCHLORIDE

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy [see Indications and Usage (1) ] . Alosetron hydrochloride should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their prescriber. Alosetron hydrochloride should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after alosetron hydrochloride is discontinued. Patients with resolved constipation should resume alosetron hydrochloride only on the advice of their treating prescriber [see Dosage and Administration (2.1) , Warnings and Precautions (5.1) , (5.2) ] . WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS See full prescribing information for complete boxed warning. Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. (1) Discontinue alosetron hydrochloride immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume alosetron hydrochloride in patients who develop ischemic colitis. (2.1, 5.1, 5.2)

Common side effects

• Constipation
• Abdominal discomfort and pain
• Nausea
• Gastrointestinal discomfort and pain

Serious adverse events

• Ischemic colitis
• Serious complications of constipation
• Hepatitis
• Elevation of ALT (>2-fold)

Key clinical trials

• Safety and Efficacy Study of GR68755 (Alosetron Hydrochloride) to Treat Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS) (PHASE2)
• Study to Assess the Effect Of Alosetron On Mucosal Blood Flow (PHASE4)
• Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy (PHASE3)
• Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• ALOSETRON HYDROCHLORIDE CI brief — competitive landscape report
• ALOSETRON HYDROCHLORIDE updates RSS · CI watch RSS