Quick answers
- What is Methylnaltrexone bromide used for?
- The FDA-approved label (Relistor, Salix Pharmaceuticals, Inc., May 1, 2024) says: “• RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Methylnaltrexone bromide have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Methylnaltrexone bromide?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Methylnaltrexone bromide been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Methylnaltrexone bromide?
- 1 company lists prescription products of Methylnaltrexone bromide in the FDA NDC Directory, including Salix Pharmaceuticals, Inc..
What Methylnaltrexone bromide is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
• RELISTOR is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. …
— FDA label: Relistor, Salix Pharmaceuticals, Inc., effective May 1, 2024. Read the full label on DailyMed →
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.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Tablet |
|---|---|
| Route | Subcutaneous · Oral |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Relistor |
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.
- Salix Pharmaceuticals, Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021964 RELISTOR | Salix Pharms | April 24, 2008 | 12, latest March 14, 2018 2018: Labeling · 2017: Labeling · 2017: Labeling |
| NDA208271 RELISTOR | Salix | July 19, 2016 | 3, latest March 14, 2018 2018: Labeling · 2017: Labeling · 2017: Labeling |
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Relistor, Salix Pharmaceuticals, Inc., effective May 1, 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 →