bosentan
Tracleer · ATC code C02KX01
Brand names: Tracleer, Bosentan Accord, Bosentan Reddy, Bosentan Sandoz, Bosentan Zentiva, Diamond, Prindan, Tractan
- Key facts
- Active substance
- bosentan
- ATC code
- C02KX01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tracleer 62.5 mg film-coated tablets / Tracleer 125 mg film-coated tablets · Tracleer 32 mg dispersible tablets
- Marketing authorisation holder
- 14437
- Information as of
- 2026-10-28
Key facts
Bosentan (Tracleer) is an endothelin receptor antagonist used to treat pulmonary arterial hypertension (PAH) and to reduce new digital ulcers in systemic sclerosis.
What it is used for
- PAH in WHO functional class III to improve exercise capacity and symptoms (primary idiopathic/heritable, secondary to scleroderma without significant interstitial lung disease, associated with congenital shunts and Eisenmenger's physiology); some improvements also in class II.
- Reduction of the number of new digital ulcers in systemic sclerosis with ongoing digital ulcer disease.
Dosing
- Adults (PAH and digital ulcers, film-coated tablets): start 62.5 mg twice daily for 4 weeks, then maintenance 125 mg twice daily; same approach when re-introducing after interruption.
- Children with PAH aged 1 year and older: 2 mg/kg morning and evening; higher doses or more frequent dosing are unlikely to add benefit. No dose recommendation in neonates with PPHN.
- The 32 mg dispersible tablet was studied only in children; in adults it is reserved for patients who cannot take the film-coated tablet.
- In late clinical deterioration, an increase to 250 mg twice daily may be considered after careful benefit/risk assessment (liver toxicity is dose dependent). Withdraw gradually.
Contraindications
- Hypersensitivity to the active substance or any excipient.
- Moderate to severe hepatic impairment (Child-Pugh class B or C).
- Baseline AST and/or ALT greater than 3 times the upper limit of normal.
- Concomitant use of ciclosporin A.
- Pregnancy, and women of childbearing potential not using reliable contraception.
Important warnings
- Dose-dependent liver aminotransferase elevations: measure before treatment, then monthly, and 2 weeks after any dose increase.
- Decreases in haemoglobin; anaemia requiring transfusion has been reported.
- Hormonal contraceptives may be rendered ineffective and cannot be the sole method of contraception; monthly pregnancy tests are recommended.
- Initiate only if systolic blood pressure is higher than 85 mmHg; consider pulmonary veno-occlusive disease if pulmonary oedema occurs.
- No beneficial effect on the healing of existing digital ulcers.
Side effects
- Most frequent: headache (11.5%), oedema/fluid retention (13.2%), abnormal liver function test (10.9%) and anaemia/haemoglobin decrease (9.9%).
- Dose-dependent elevations in liver aminotransferases and decreases in haemoglobin concentration.
Interactions
- Bosentan induces CYP2C9 and CYP3A4 (in vitro also CYP2C19), lowering levels of drugs metabolised by these enzymes.
- Ciclosporin A is contraindicated; glibenclamide, fluconazole and rifampicin are not recommended; avoid combining a CYP3A4 inhibitor and a CYP2C9 inhibitor with bosentan.
Pregnancy and breastfeeding
- Contraindicated in pregnancy; teratogenic and embryotoxic in animal studies.
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.
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)
- Tracleer14437 · EMEA/H/C/000401
Source: European Medicines Agency (EMA), product information
Austria
- Bosentan AccordAccord Healthcare B.V. · 1 register entry
- Bosentan ReddyReddy Holding Gmbh · 1 register entry
- Bosentan SandozSandoz Gmbh · 1 register entry
- Bosentan ZentivaZentiva, K.S. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- Bosentan1 A Pharma Gmbh, Pharmascience International Ltd, Ratiopharm Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Stragen Pharma Gmbh, Zentiva Pharma Gmbh, Accord Healthcare B.V., Basics Gmbh, Cipla Europe Nv, Hexal Ag, Puren Pharma Gmbh & Co. Kg, Betapharm Arzneimittel Gmbh, Aliud Pharma Gmbh · 13 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- DiamondABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
- PrindanSANOVEL İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- TracleerJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 4 register entries
- TractanHUMANİS SAĞLIK A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 27 more European countries
- Belgium
- Bosentan Accord, Bosentan Sandoz
- Bulgaria
- Bosentan Sdz, Бозентан Акорд, Бозентан Зентива, Ипертазин
- Croatia
- Bosentan Cipla, Bosentan Makpharm, Bosentan Zentiva, Phan
- Cyprus
- Bactoced, Bosentan Accord, Bosentan Aurobindo, Sentoba
- Czechia
- Bosentan Abdi, Bosentan Accord
- Denmark
- Bosentan Accord, Bosentan Cipla, Bosentan Zentiva
- Estonia
- Bosentan Accord, Bosentan Norameda
- Finland
- Bosentan Accord
- France
- Bosentan Accord, Bosentan Arrow, Bosentan Stragen, Bosentan Sun, Bosentan Viatris
- Greece
- Bocleer, Klimurtan, Sentoba, Vradem
- Hungary
- Bosentan Pharmascience
- Iceland
- Stayveer, Tracleer
- Ireland
- Bosentan Accord, Bosentan Zentiva
- Italy
- Bosentan Abdi, Bosentan Accord, Bosentan Accordpharma, Bosentan Aurobindo, Bosentan Mylan, Bosentan Sun, Bosentan Teva
- Latvia
- Bosentan Accord, Bosentan Norameda, Bosentan Zentiva
- Liechtenstein
- Stayveer, Tracleer
- Lithuania
- Bosentan Accord, Bosentan Norameda, Bosentan Zentiva
- Malta
- Bosentan Aurobindo
- Netherlands
- Bosentan Abdi, Bosentan Accord, Bosentan Monohydrate Aurobindo, Bosentan Sandoz, Bosentan Teva, Bosentan Zentiva
- Norway
- Bosentan Accord, Bosentan Cipla, Bosentan Sandoz, Stayveer, Tracleer
- Poland
- Bopaho, Bosentan Accord, Bosentan Ranbaxy, Bosentan Sandoz Gmbh
- Portugal
- Bosentano Accord, Bosentano Aurobindo, Bosentano Mylan, Bosentano Normon, Bosentano Sandoz, Sentoba
- Romania
- Bopaho, Bosentan Accord, Bosentan Terapia
- Slovakia
- Bosentan Accord
- Slovenia
- Bosentan Norameda
- Spain
- Bosentan Accordpharma, Bosentan Aurovitas, Bosentan Cipla, Bosentan Kern Pharma, Bosentan Mylan, Bosentan Normon, Bosentan Sun, Bosentán Accordpharma, Bosentán Sandoz Farmacéutica
- Sweden
- Bosentan Accord, Bosentan Sandoz, Bosentan Zentiva
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Tracleer – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tracleer-epar-product-information_en.pdf
- 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
- 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
- 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.