Quick answers
- What is Alosetron hydrochloride used for?
- The FDA-approved label (Lotronex, Sebela Pharmaceuticals Inc., June 30, 2026) says: “LOTRONEX is 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alosetron hydrochloride have a boxed warning?
- Yes. The FDA label for Lotronex has a boxed warning (“WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Alosetron hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alosetron hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alosetron hydrochloride?
- 8 companies list prescription products of Alosetron hydrochloride in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, Legacy Pharma USA Inc. and Eywa Pharma Inc.
What Alosetron hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LOTRONEX is 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 …
— FDA label: Lotronex, Sebela Pharmaceuticals Inc., effective June 30, 2026. Read the full label on DailyMed →
The FDA has 9 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS
. Read it on the full label →
9 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 16 in the FDA NDC Directory |
| Brand names | Lotronex |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| alosetron hydrochloride 0.5 mg tablet | Generic | $2.02 per tablet |
| alosetron hydrochloride 0.5 mg tablet, film coated | Generic | $2.02 per tablet |
| alosetron hydrochloride 1 mg tablet | Generic | $3.05 per tablet |
| alosetron hydrochloride 1 mg tablet, film coated | Generic | $3.05 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals of New York LLC2 products
- Legacy Pharma USA Inc.2 products
- Eywa Pharma Inc2 products
- AvKARE2 products
- Bryant Ranch Prepack2 products
- Amneal Pharmaceuticals LLC2 products
- Lifestar Pharma LLC2 products
- Sebela Pharmaceuticals Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021107 LOTRONEX | Legacy | February 9, 2000 | 20, latest September 8, 2023 2023: REMS · 2019: Labeling · 2016: REMS |
Generic approvals (3)
- ANDA206647Amneal Pharms · December 22, 2016
- ANDA211621Adaptis · September 16, 2019
- ANDA213614Mankind Pharma · September 9, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 259306, 261362, 403975, 540181 |
|---|---|
| SPL set ID of the quoted label | 35cbb9d5-639b-207a-e054-00144ff88e88 |
| FDA labels (SPL) | 9 |
| FDA applications | NDA021107, 3 ANDA |
| Active ingredients (FDA) | ALOSETRON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lotronex, Sebela Pharmaceuticals Inc., effective June 30, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →