FDA label
What is alosetron used for?
The FDA-approved uses of alosetron, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer),; had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and; not responded adequately to conventional therapy; frequent and severe abdominal pain/discomfort,; frequent bowel urgency or fec...”
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Alosetron Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Amneal Pharmaceuticals of New York LLC (ANDA206647). Cross-references to other label sections are left out.
Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:
- chronic IBS symptoms (generally lasting 6 months or longer),
- had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
- not responded adequately to conventional therapy.
Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:
- frequent and severe abdominal pain/discomfort,
- frequent bowel urgency or fecal incontinence,
- disability or restriction of daily activities due to IBS.
Because of infrequent but serious gastrointestinal adverse reactions associated with alosetron tablets, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.
Clinical studies have not been performed to adequately confirm the benefits of alosetron tablets in men.
Source: DailyMed label, set id 2927e7d0-b1b8-4944-a7e8-97b60eb9bb71, version 1, effective March 26, 2023. NDC 53746-248, one of 6 listings for this product.
Questions
What is alosetron used for?
The FDA label says: “Alosetron tablets are indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have: chronic IBS symptoms (generally lasting 6 months or longer),; had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and; not responded adequately to conventional therapy; frequent and severe abdominal pain/discomfort,; frequent bowel urgency or fec...”
What drug class is alosetron?
FDA lists alosetron in the Serotonin-3 Receptor Antagonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.