Prescription medicine
Metyrosine Brand names: Demser
Metyrosine (Demser) is a prescription medicine with an FDA approval on record since 1979. FDA's NDC Directory lists it from 2 generic labelers.
- Generic listed
Check it at the source: the metyrosine FDA label on DailyMed (effective July 1, 2021, Bausch Health US, LLC); the NDA 17871 record on Drugs@FDA; every metyrosine label on DailyMed.
Highlights of the record
FDA label of July 1, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDEMSER is indicated in the treatment of patients with pheochromocytoma for: 1.
Forms and strengths
- 250 mg
Capsule.
On the market
- Earliest approval on file
- October 3, 1979 Demser, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first July 24, 2020; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 2 under generic applications, 1 under brand applications, repackagers included
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
- 79 through July 30, 2026
What is metyrosine used for?
From the label: indications and usageDEMSER 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 pharmacologic class: Catecholamine Synthesis Inhibitor.
Source: FDA drug label (Demser), Bausch Health US, LLC, effective July 1, 2021 (SPL set 32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92), via openFDA; the full label on DailyMed
Is there a generic for metyrosine (Demser)?
The FDA approved the first generic metyrosine on July 24, 2020. 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 metyrosine from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1979 earliest approval on file
- 2020 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the metyrosine label say about other medicines?
The metyrosine label names 2 other medicines 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 |
|---|---|---|
| Lidocaine | warnings | In addition, life-threatening arrhythmias may occur during anesthesia and surgery, and may require treatment with a beta-blocker or lidocaine. |
| Phentolamine | warnings | … hypertensive crises or arrhythmias during manipulation of the tumor, and the alpha-adrenergic blocking drug, phentolamine, may be needed. |
Source: FDA drug label (Demser), Bausch Health US, LLC, effective July 1, 2021 (SPL set 32fb2f2f-34b5-4cd5-9145-c3ab37c5ca92), via openFDA; the full label on DailyMed
What do FAERS reports show for metyrosine?
The FDA Adverse Event Reporting System holds 79 reports that list metyrosine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 33 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?
- Metyrosine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other