Methyldopa

Aldometil · ATC code C02AB01

Also known as: Metildopa · Brand names: Aldometil, Dopegyt, Methyldopa Stada, Presinol, Alfamet

Key facts
Active substance
Methyldopa
Drug class
Methyldopa
ATC code
C02AB01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Methyldopa is a centrally acting antihypertensive. Per the US prescribing information, the tablets are used to treat hypertension.

What it is used for

  • Hypertension

Dosing

  • Adults: usually 250 mg two to three times a day in the first 48 hours, then adjusted at intervals of not less than 2 days; start dose increases in the evening to minimize sedation
  • With antihypertensives other than thiazides, limit the initial dose to 500 mg daily in divided doses
  • Maintenance: 500 mg to 2 g daily in two to four doses; maximum 3 g daily
  • Impaired renal function and older patients may respond to smaller doses
  • Children: initially 10 mg/kg daily in two to four doses; maximum 65 mg/kg or 3 g daily, whichever is less

Contraindications

  • Active hepatic disease such as acute hepatitis and active cirrhosis
  • Liver disorders previously associated with methyldopa
  • Hypersensitivity to any component
  • Therapy with MAO inhibitors

Important warnings

  • Positive direct Coombs test in 10% to 20% of patients on prolonged therapy, rarely with hemolytic anemia that can be fatal; blood counts before and during therapy
  • Liver disorders, including hepatitis and jaundice, potentially fatal if not recognized; liver tests recommended
  • Sedation, usually transient, at the start or when the dose is increased
  • Tolerance may develop, usually between the second and third month; adding a diuretic often restores control

Side effects

  • Sedation, headache, asthenia or weakness, usually early and transient
  • Orthostatic hypotension, edema or weight gain, bradycardia, aggravation of angina
  • Dry mouth, nausea, vomiting, diarrhea; hyperprolactinemia
  • Serious: hemolytic anemia, bone marrow depression, hepatitis, myocarditis, pancreatitis, lupus-like syndrome

Interactions

  • Other antihypertensives: potentiated effect; doses may need adjustment
  • Lithium: monitor for lithium toxicity
  • Ferrous sulfate or ferrous gluconate: reduced bioavailability of methyldopa
  • Anesthetics: reduced doses may be required; MAO inhibitors are contraindicated

Pregnancy and breastfeeding

  • Use during pregnancy only if clearly needed; published reports across all trimesters suggest the possibility of fetal harm appears remote

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • AldometilH.A.C. Pharma · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • DopegytCheplapharm Arzneimittel Gmbh · 1 register entry
  • Methyldopa StadaStadapharm Gmbh · 1 register entry
  • PresinolTeofarma S.R.L. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • AlfametMENARİNİ SAĞLIK VE İLAÇ SAN. TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 18 more European countries
Belgium
Aldomet
Bulgaria
Допегит
Czechia
Dopegyt
Denmark
Methyldopa Macure
Finland
Methyldopa Macure
France
Aldomet
Hungary
Dopegyt
Italy
Aldomet
Latvia
Dopegyt
Lithuania
Dopegyt
Netherlands
L-Methyldopa Teva, Methyldopa Cf
Norway
Methyldopa Macure
Poland
Dopegyt
Portugal
Aldomet
Romania
Dopegyt
Slovakia
Dopegyt
Spain
Aldomet
Sweden
Methyldopa Macure

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Sources

  1. U.S. Food and Drug Administration. Methyldopa (Rising Pharma Holdings, Inc.) – Prescribing Information, 2025-03-28. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9e22e1d8-04ec-4b67-92ea-b09c706f2703
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC C02AB.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.