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Labetalol

Trandate · ATC code C07AG01

Key facts
Active substance
Labetalol
Drug class
Beta blocker
ATC code
C07AG01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Labetalol is a combined alpha- and beta-adrenergic blocker. Per the US prescribing information, the tablets are used to manage hypertension, alone or with other antihypertensives, especially thiazide and loop diuretics.

What it is used for

  • Hypertension, alone or combined with other antihypertensive agents, especially thiazide and loop diuretics

Dosing

  • Dosage must be individualized; initially 100 mg twice daily, alone or added to a diuretic
  • After 2 or 3 days, may be titrated in increments of 100 mg twice daily every 2 or 3 days, guided by standing blood pressure
  • Usual maintenance: 200 mg to 400 mg twice daily; severe hypertension may require 1200 mg to 2400 mg per day (three times daily dosing may improve tolerability); increments should not exceed 200 mg twice daily
  • With a diuretic, optimal doses are usually lower
  • Elderly patients: most need 100 mg to 200 mg twice daily; caution in impaired hepatic function

Contraindications

  • Bronchial asthma or history of obstructive airway disease
  • Overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia
  • Other conditions with severe and prolonged hypotension
  • Hypersensitivity to any component of the product

Important warnings

  • Rare severe hepatocellular injury, including hepatic necrosis and death; periodic liver tests; stop and do not restart if liver injury or jaundice occurs
  • Cardiac failure
  • Exacerbation of ischemic heart disease after abrupt withdrawal; withdraw gradually
  • May mask early signs of hypoglycemia, especially in diabetes
  • Paradoxical hypertensive responses in pheochromocytoma; intraoperative floppy iris syndrome during cataract surgery

Side effects

  • Most common (probably drug-related): nausea (6%), fatigue (5%), dizziness, dyspepsia, nasal stuffiness (3%)
  • Also: ejaculation failure, impotence, headache, dyspnea, edema, postural hypotension
  • Scalp tingling (paresthesia), usually mild and transient at the start of treatment
  • Serious: hepatic injury, lupus-like reactions

Interactions

  • Tricyclic antidepressants: more tremor reported
  • Beta-agonist bronchodilators: effect may be blunted
  • Cimetidine increases labetalol bioavailability – special care in dosing
  • Diuretics: additive antihypertensive effect

Pregnancy and breastfeeding

  • No reproducible fetal malformations in animal studies; see the full text
  • Small amounts pass into breast milk; caution when breastfeeding

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

  • TrandateAspen Pharma Trading Limited · 1 register entry

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

Turkey

  • LablolALİ RAİF İLAÇ SAN. A.Ş. · 1 register entry

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

Brand names in 16 more European countries
Belgium
Trandate
Cyprus
Trandate
Denmark
Labetalol S.A.L.F., Trandate
Estonia
Trandate
Finland
Albetol, Labetalol S.A.L.F.
France
Labetalol Stragen, Trandate
Iceland
Trandate
Ireland
Labetalol S.A.L.F. S.P.A. Laboratorio, Trandate
Italy
Labetalolo S.A.L.F., Trandate
Luxembourg
Trandate
Malta
Labetalol S.A.L.F.
Netherlands
Labetalol Hcl Mylan, Trandate Injectie
Norway
Labetalol S.A.L.F., Trandate
Portugal
Labetalol Pharmakern, Labetalol S.A.L.F.
Spain
Labetalol S.A.L.F., Trandate
Sweden
Labetalol S.A.L.F., Trandate

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

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Labetalol Hydrochloride (BluePoint Laboratories Inc.) – Prescribing Information, 2026-06-08. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63ede355-42ec-4c52-a941-51e5f6b35ed6
  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. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  4. Wikidata (CC0): ATC C07AG.

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.