Quick answers
- What is Alvimopan used for?
- The FDA-approved label (Alvimopan, Par Health USA, LLC, February 2, 2024) says: “Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Alvimopan have a boxed warning?
- Yes. The FDA label for Alvimopan has a boxed warning (“WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Alvimopan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Alvimopan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Alvimopan?
- 4 companies list prescription products of Alvimopan in the FDA NDC Directory, including Hikma Pharmaceuticals USA Inc., Golden State Medical Supply, Inc. and Par Health USA, LLC.
What Alvimopan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. Alvimopan capsules are an opioid antagonist indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
— FDA label: Alvimopan, Par Health USA, LLC, effective February 2, 2024. Read the full label on DailyMed →
The FDA has 2 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.
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: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY
. Read it on the full label →
2 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 4 in the FDA NDC Directory |
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.
- Hikma Pharmaceuticals USA Inc.1 product
- Golden State Medical Supply, Inc.1 product
- Par Health USA, LLC1 product
- Actavis Pharma, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA208295Watson Labs Teva · December 19, 2019
- ANDA216843Ph Health · January 24, 2023
- ANDA217753Hikma · August 31, 2023
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) | 799835 |
|---|---|
| SPL set ID of the quoted label | 1cd584de-b704-4d26-8451-e3247ffb8d08 |
| FDA labels (SPL) | 2 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | ALVIMOPAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Alvimopan, Par Health USA, LLC, effective February 2, 2024; 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 →