Quick answers
- What is Metyrosine used for?
- The FDA-approved label (Demser, Bausch Health US, LLC, July 1, 2021) says: “DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Metyrosine have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Metyrosine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Metyrosine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Metyrosine?
- 4 companies list prescription products of Metyrosine in the FDA NDC Directory, including Bausch Health US, LLC, Oceanside Pharmaceuticals and Dr. Reddy's Laboratories Inc..
What Metyrosine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
DEMSER is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma DEMSER is not recommended for the control of essential hypertension.
— FDA label: Demser, Bausch Health US, LLC, effective July 1, 2021. Read the full label on DailyMed →
The FDA has 3 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.
The label quoted above has no boxed warning.
0 of 3 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 |
| Brand names | Demser |
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.
- Bausch Health US, LLC1 product
- Oceanside Pharmaceuticals1 product
- Dr. Reddy's Laboratories Inc.1 product
- Amneal Pharmaceuticals LLC1 product
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 |
|---|---|---|---|
| NDA017871 DEMSER | Bausch | October 3, 1979 | 11, latest July 15, 2014 2014: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2003: Labeling |
Generic approvals (2)
- ANDA213734Amneal · July 24, 2020
- ANDA218620DR Reddys Labs SA · April 9, 2025
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) | 197980, 201388 |
|---|---|
| SPL set ID of the quoted label | 32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA017871, 2 ANDA |
| Active ingredients (FDA) | METYROSINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Demser, Bausch Health US, LLC, effective July 1, 2021; 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 →