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ambrisentan

Volibris · ATC code C02KX02

Brand names: Volibris, Ambrisentan Accord, Ambrisentan Aop, Ambrisentan Ratiopharm, Ambrisentan Sandoz, Ambripuren, Ancatis, Volimra

Key facts
Active substance
ambrisentan
ATC code
C02KX02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Volibris 2.5 mg film-coated tablets / Volibris 5 mg film-coated tablets / Volibris 10 mg film-coated tablets
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-28

Key facts

Ambrisentan is an endothelin receptor antagonist (ERA). It is used to treat pulmonary arterial hypertension (PAH) in adults and in children and adolescents aged 8 years and older.

What it is used for

  • PAH of WHO Functional Class II to III in adults, including combination treatment; efficacy shown in idiopathic PAH and PAH associated with connective tissue disease.
  • PAH of WHO Functional Class II to III in children and adolescents aged 8 to less than 18 years, including combination treatment.

Dosing

  • Volibris (film-coated tablets), adults, monotherapy: start at 5 mg once daily; may be increased to 10 mg daily depending on clinical response and tolerability.
  • Adults, combination with tadalafil: titrate to 10 mg once daily.
  • Adults taking ciclosporin A: limit ambrisentan to 5 mg once daily and monitor carefully.
  • Children and adolescents aged 8 to less than 18 years: dosing by body weight – see the full text.
  • Severe hepatic impairment: contraindicated.

Contraindications

  • Hypersensitivity to the active substance, to soya, or to any of the excipients.
  • Pregnancy; women of child-bearing potential not using reliable contraception; breast-feeding.
  • Severe hepatic impairment (with or without cirrhosis); baseline AST and/or ALT > 3xULN.
  • Idiopathic pulmonary fibrosis (IPF), with or without secondary pulmonary hypertension.

Important warnings

  • Liver: cases of autoimmune hepatitis, hepatic injury and enzyme elevations; check ALT and AST before starting, monthly monitoring is recommended; discontinue for sustained unexplained elevation or signs of hepatic injury.
  • Decreases in haemoglobin and haematocrit, mostly in the first 4 weeks; consider dose reduction or discontinuation for clinically significant decrease.
  • Fluid retention and peripheral oedema, sometimes requiring hospitalisation or causing decompensated heart failure; more frequent and severe in patients ≥65 years.
  • If acute pulmonary oedema develops, pulmonary veno-occlusive disease should be considered.
  • Contains lactose and soya lecithin.

Side effects

  • Most common: peripheral oedema (37%) and headache (28%); more frequent at the higher dose (10 mg).
  • Serious: anaemia (decreased haemoglobin and haematocrit) and hepatotoxicity; hepatic enzyme elevations (2%), autoimmune hepatitis.

Interactions

  • Ciclosporin A causes a 2-fold increase in ambrisentan exposure; limit the dose.
  • Rifampicin: transient increase in exposure at the start; monitor closely when starting rifampicin.
  • Combination with tadalafil: higher incidence of anaemia and peripheral oedema.

Pregnancy and breastfeeding

  • Contraindicated in pregnancy (teratogenic in animals). Negative pregnancy test and reliable contraception required before starting; monthly pregnancy tests are recommended.
  • Breast-feeding is contraindicated.

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 →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

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.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Ambrisentan AccordAccord Healthcare B.V. · 1 register entry
  • Ambrisentan AopAop Orphan Pharmaceuticals Gmbh · 1 register entry
  • Ambrisentan RatiopharmTeva B.V · 1 register entry
  • Ambrisentan SandozSandoz Gmbh · 1 register entry

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

Germany

  • AmbripurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • AmbrisentanAliud Pharma Gmbh, Ratiopharm Gmbh, Bluefish Pharmaceuticals Ab, Devatis Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Vivanta Generics S.R.O, Zentiva Pharma Gmbh, Accord Healthcare B.V., Axunio Pharma Gmbh, Cipla Europe Nv, Olpha As, Betapharm Arzneimittel Gmbh, Abz-Pharma Gmbh · 15 register entries

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

Turkey

  • AncatisSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • VolibrisGLAXOSMİTHKLİNE İLAÇLARI SAN. VE TİC. A.Ş. · 4 register entries
  • VolimraDEVA HOLDİNG A.Ş. · 4 register entries

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

Brand names in 24 more European countries
Belgium
Ambrisentan Accord, Ambrisentan Sandoz
Bulgaria
Aмбрисентан Aкорд, Амбрисентан Зентива, Амбрисентан Тева
Croatia
Ambrisentan Accord
Cyprus
Ambrisentan Msn, Ambrisentan Sapiens
Czechia
Ambrisentan Accord, Ambrisentan Sandoz, Ambrisentan Zentiva
Denmark
Ambrisentan "sandoz", Ambrisentan Accord, Ambrisentan Olpha, Ambrisentan Teva
Estonia
Ambrisentan Inteli, Ambrisentan Norameda, Ambrisentan Zentiva
Finland
Ambrisentan Accord
France
Ambrisentan Accord, Ambrisentan Arrow, Ambrisentan Bluefish, Ambrisentan Olpha, Ambrisentan Stragen, Ambrisentan Teva
Greece
Ambicipen, Ambrisentan Accord, Ambrisentan Genepharm
Hungary
Ambrisentan Azr
Iceland
Ambrisentan Viatris, Volibris
Ireland
Ambrisentan Accord
Italy
Ambrisentan Accord, Ambrisentan Medac, Ambrisentan Teva
Latvia
Ambrisentan Inteli, Ambrisentan Norameda, Ambrisentan Zentiva
Liechtenstein
Ambrisentan Viatris, Volibris
Lithuania
Ambrisentan Aop, Ambrisentan Inteli, Ambrisentan Norameda, Ambrisentan Zentiva
Netherlands
Ambrisentan Accord, Ambrisentan Aop, Ambrisentan Devatis, Ambrisentan Genepharm, Ambrisentan Sandoz, Ambrisentan Zentiva
Norway
Ambrisentan Accord, Ambrisentan Viatris, Volibris
Portugal
Ambrisentano Accord, Ambrisentano Generis, Ambrisentano Teva
Slovakia
Ambrisentan Aop
Slovenia
Ambrisentan Accord
Spain
Ambrisentan Accord, Ambrisentan Kern Pharma, Ambrisentan Olpha, Ambrisentán Aurovitas, Ambrisentán Kern Pharma, Ambrisentán Sala, Ambrisentán Vivanta
Sweden
Ambrisentan Accord, Ambrisentan Bluefish, Ambrisentan Sandoz

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

Sources

  1. European Medicines Agency. Volibris – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/volibris-epar-product-information_en.pdf
  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

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.