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Atovaquone

ATC code P01AX06

Also known as: Atovaquon, Atovakon

Key facts
Active substance
Atovaquone
ATC code
P01AX06
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Atovaquone is an antiprotozoal agent. Per the US prescribing information, its oral suspension (MEPRON) is used to prevent and treat Pneumocystis jirovecii pneumonia.

What it is used for

  • Prevention of Pneumocystis jirovecii pneumonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprim-sulfamethoxazole (TMP-SMX)
  • Acute oral treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX
  • More severe PCP episodes and failure of TMP-SMX therapy have not been studied

Dosing

  • Prevention: 1,500 mg (10 mL) once daily with food
  • Treatment: 750 mg (5 mL) twice daily (total daily dose 1,500 mg) with food for 21 days
  • Always take with food to avoid low plasma concentrations; shake the bottle gently before use

Contraindications

  • Development or history of hypersensitivity reactions to atovaquone or any component of MEPRON

Important warnings

  • Limited absorption: without food, lower plasma levels may limit response; consider other agents in patients who have difficulty taking it with food or with gastrointestinal disorders limiting absorption
  • Hepatotoxicity: cholestatic hepatitis, elevated liver enzymes and fatal liver failure have been reported; monitor closely in severe hepatic impairment
  • Severe cutaneous adverse reactions (SJS, DRESS, erythema multiforme), which can be life-threatening or fatal; discontinue immediately and do not rechallenge

Side effects

  • Treatment trial (tablets): rash 23%, nausea 21%, diarrhea 19%, headache 16%, vomiting 14%, fever 14%, insomnia 10%
  • Gastrointestinal reactions (nausea, diarrhea, vomiting) more frequent than with dapsone in the prevention trial
  • Serious: hepatotoxicity and severe cutaneous reactions

Interactions

  • Rifampin or rifabutin: reduce atovaquone concentrations; coadministration not recommended
  • Tetracycline: reduced atovaquone concentrations; use caution and monitor for loss of efficacy
  • Metoclopramide: may reduce bioavailability; use only if other antiemetics are not available
  • Indinavir: decreased indinavir trough concentrations; use caution

Pregnancy and breastfeeding

  • Data from use in pregnant women are insufficient to identify a drug-associated risk
  • No data on presence in human milk; in HIV-1 infection, breastfeeding carries a risk of HIV-1 transmission

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.

Germany

  • Atovaquon GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
  • WellvoneGlaxosmithkline Gmbh & Co. Kg · 1 register entry

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

USA

  • MepronGlaxoSmithKline LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 11 more European countries
Belgium
Wellvone
Denmark
Atovaquone Glenmark
France
Atovaquone Biogaran, Wellvone
Greece
Atovaquone Vocate, Wellvone
Italy
Atovaquone Glenmark, Wellvone
Luxembourg
Wellvone
Netherlands
Atovaquon Glenmark, Wellvone
Norway
Atovaquone Glenmark
Portugal
Atovaquona Kabi, Wellvone
Spain
Atovacuona Glenmark, Wellvone
Sweden
Atovaquone Glenmark, Wellvone

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.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. U.S. Food and Drug Administration. MEPRON (GlaxoSmithKline LLC) – Prescribing Information, 2026-03-20. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b426b6bf-f07e-4580-97ae-dfca1ddf5b8f
  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. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

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.