Prescription medicine
Alvimopan First approved as Entereg
Alvimopan (Entereg) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 4 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the alvimopan FDA label on DailyMed (effective October 24, 2022, Hikma Pharmaceuticals USA Inc.); the NDA 21775 record on Drugs@FDA; every alvimopan label on DailyMed.
Highlights of the record
FDA label of October 24, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY.
There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with alvimopan, no increased risk of myocardial infarction was observed [see Warnings and Precautions ( 5.1 )]. Because of the potential risk of myocardial infarction with long-term use, alvimopan is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the Alvimopan REMS Program [see Warnings and Precautions ( 5.1 , 5.2 )]. WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY See full prescribing information for complete boxed warning.
Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. ( 5.1 )
Alvimopan capsules are available only through a restricted program for short-term use (15 doses) called the Alvimopan REMS Program.
Used for
From the label: indications and usageAlvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.
Forms and strengths
- 12 mg
Capsule.
On the market
- Earliest approval on file
- May 20, 2008 Entereg, Cubist Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first December 19, 2019; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 4 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- February 12, 2030 Entereg capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 43 through July 30, 2026
What is alvimopan used for?
From the label: indications and usageAlvimopan 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 pharmacologic class: Opioid Antagonist.
Source: FDA drug label (Alvimopan), Hikma Pharmaceuticals USA Inc., effective October 24, 2022 (SPL set 59ef406b-79db-4efd-b993-08b937ac682b), via openFDA; the full label on DailyMed
Is there a generic for alvimopan (Entereg)?
The FDA approved the first generic alvimopan on December 19, 2019. 3 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists alvimopan from 4 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Entereg capsules, the last expiring on February 12, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2019 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the alvimopan label say about other medicines?
The alvimopan label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Morphine | drug interactions | DRUG INTERACTIONS 7.1 Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. |
Source: FDA drug label (Alvimopan), Hikma Pharmaceuticals USA Inc., effective October 24, 2022 (SPL set 59ef406b-79db-4efd-b993-08b937ac682b), via openFDA; the full label on DailyMed
What do FAERS reports show for alvimopan?
The FDA Adverse Event Reporting System holds 43 reports that list alvimopan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 32 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other opioid antagonists
- the pharmacologic class, with prices and generics
- Alvimopan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other