Prescription medicine
Methyldopa First approved as Aldomet
Methyldopa (Aldomet) is a prescription medicine with an FDA approval on record since 1962. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the methyldopa FDA label on DailyMed (effective March 26, 2025, Chartwell RX, LLC); the NDA 13400 record on Drugs@FDA; every methyldopa label on DailyMed.
Highlights of the record
FDA label of March 26, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHypertension.
Forms and strengths
- 250 mg
- 500 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- December 20, 1962 Aldomet, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first April 18, 1985; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 1 under generic applications, 0 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)
- 1 since 2014 0 Class I among all firms' recalls; latest March 24, 2014
- FAERS reports
- 4,842 through July 30, 2026
What is methyldopa used for?
From the label: indications and usageHypertension.
FDA pharmacologic class: Central alpha-2 Adrenergic Agonist.
Source: FDA drug label (Methyldopa), Chartwell RX, LLC, effective March 26, 2025 (SPL set e1114a58-9ab5-486e-85ed-360365b06396), via openFDA; the full label on DailyMed
Is there a generic for methyldopa (Aldomet)?
The FDA approved the first generic methyldopa on April 18, 1985. 23 generic applications are approved; 2 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 methyldopa from 1 labeler 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.
- 1962 earliest approval on file
- 1985 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has methyldopa been recalled?
The FDA's Enforcement Report lists 1 recall naming methyldopa since 2014: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 24, 2014 | Class II | Teva Pharmaceuticals USA | CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the methyldopa label say about other medicines?
The methyldopa label names no other medicine on this site. The labels of 11 other medicines name methyldopa. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name methyldopa
Source: FDA drug label (Methyldopa), Chartwell RX, LLC, effective March 26, 2025 (SPL set e1114a58-9ab5-486e-85ed-360365b06396), via openFDA; the full label on DailyMed
What do FAERS reports show for methyldopa?
The FDA Adverse Event Reporting System holds 4,842 reports that list methyldopa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 227 are coded as a death and 1,610 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to methyldopa
- medicines labeled for the same conditions
- Other central alpha-2 adrenergic agonists
- the pharmacologic class, with prices and generics
- Methyldopa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other