Is Bosentan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Bosentan, including BOSENTOR 125 mg Film-Coated Tablet (125 mg, Tablet, SAR 6115.65); BOSENTOR 62.5 mg Film-Coated Tablet (62.5 mg, Tablet, SAR 6115.65); Bosentan OHRE Pharma (62.5 mg, Film-coated tablet, SAR 5504.10); Bosentan OHRE Pharma (125 mg, Film-coated tablet, SAR 5504.10); Bosfit (125 mg, Film-coated tablet, SAR 4874.80).

Is Bosentan approved by the US FDA?

Drugs@FDA lists 15 application product lines for Bosentan, including TRACLEER (Prescription); TRACLEER (Prescription); BOSENTAN (Prescription); BOSENTAN (Prescription); BOSENTAN (Prescription).

Is Bosentan authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Bosentan: Tracleer, Stayveer.

Are there safety signals or safety updates for Bosentan?

US FDA: 2 entries (latest 2025-11-05).

Active substance

Bosentan

SFDA 15
US FDA 15
EMA 2
Health Canada 6
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BOSENTOR 125 mg Film-Coated Tablet	125 mg	Tablet · Oral use	60 Blister	SAR 6115.65	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
BOSENTOR 62.5 mg Film-Coated Tablet	62.5 mg	Tablet · Oral use	60 Blister	SAR 6115.65	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Bosentan OHRE Pharma	62.5 mg	Film-coated tablet · Oral use	56 Blister	SAR 5504.10	Generic · Prescription	OHRE Pharma	Valid
Bosentan OHRE Pharma	125 mg	Film-coated tablet · Oral use	56 Blister	SAR 5504.10	Generic · Prescription	OHRE Pharma	Valid
Bosfit	125 mg	Film-coated tablet · Oral use	56 Blister	SAR 4874.80	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
Bosfit	62.5 mg	Film-coated tablet · Oral use	56 Blister	SAR 4874.80	Generic · Prescription	ALTAIF PHARMACEUTICALS COMPANY	Valid
GONISTA 125MG F.C TABLETS	125 mg	Film-coated tablet · Oral use	60 Blister	SAR 5504.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
GONISTA 62.5MG F.C TABLETS	62.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 5504.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
PERTENSIO 125 mg Film-Coated Tablet	125 mg	Film-coated tablet · Oral use	56 Blister	SAR 6115.65	Generic · Prescription	SPIMACO ADDWAEIH	Valid
TRACLEER 125 MG FILM COATED TABLET	125 mg	Film-coated tablet · Oral use	56 Bottle	SAR 7526.95	NCE · Prescription	ACTELTION PHARMACEUTICALS LTD	Valid
TRACLEER 62.5 MG FILM COATED TABLET	62.5 mg	Film-coated tablet · Oral use	56 Bottle	SAR 7526.95	NCE · Prescription	ACTELTION PHARMACEUTICALS LTD	Valid
BOSENTOR 125 mg Film-Coated Tablet	125 mg	Tablet · Oral use	60 Blister	SAR 6115.65	Generic · Prescription	PHARMASCIENCE INC.	Withdrawn by MAH · Not Marketed
BOSENTOR 62.5 mg Film-Coated Tablet	62.5 mg	Tablet · Oral use	60 Blister	SAR 6115.65	Generic · Prescription	PHARMASCIENCE INC.	Withdrawn by MAH · Not Marketed
ECOLE 125 mg Film-Coated Tablet	125 mg	Film-coated tablet · Oral use	56 Blister	SAR 6795.15	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
ECOLE 62.5 mg Film-Coated Tablet	62.5 mg	Film-coated tablet · Oral use	56 Blister	SAR 6795.15	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

PULMONARY ARTERIAL HYPERTENSION; RAYNAUD'S PHENOMENON

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TRACLEER	62.5MG; 125MG	tablet · oral	ACTELION	Prescription	20 Nov 2001
TRACLEER	32MG	tablet, for suspension · oral	ACTELION	Prescription	5 Sep 2017
BOSENTAN	62.5MG; 125MG	tablet · oral	WATSON LABS INC	Prescription	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	ZYDUS PHARMS	Prescription	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	SUN PHARM	Prescription	26 Apr 2019
BOSENTAN	32MG	tablet, for suspension · oral	NATCO PHARMA LTD	Prescription	5 Feb 2025
BOSENTAN	32MG	tablet, for suspension · oral	ZYDUS PHARMS	Prescription	17 Feb 2026
BOSENTAN	62.5MG; 125MG	tablet · oral	PH HEALTH	Discontinued	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	ALVOGEN PINE BROOK	Discontinued	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	NATCO PHARMA LTD	Discontinued	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	HIKMA PHARMS	Discontinued	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	AMNEAL PHARMS CO	Discontinued	26 Apr 2019
BOSENTAN	62.5MG; 125MG	tablet · oral	CHARTWELL MOLECULAR	Discontinued	3 Jan 2020
BOSENTAN	62.5MG; 125MG	tablet · oral	MYLAN	Discontinued	15 Jan 2020
BOSENTAN	62.5MG; 125MG	tablet · oral	ALEMBIC	Discontinued	23 Jan 2020

EMA European Union — centrally authorised medicines

Tracleer · Authorised · authorised 14 May 2002 · ATC C02KX01

Therapeutic indication (EMA)

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III.Efficacy has been shown in: Primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger's physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.

Stayveer Janssen-Cilag International NV · Authorised · authorised 24 Jun 2013 · ATC C02KX01

Therapeutic indication (EMA)

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO) functional class III. Efficacy has been shown in: primary (idiopathic and familial) PAH; PAH secondary to scleroderma without significant interstitial pulmonary disease; PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology. Some improvements have also been shown in patients with PAH WHO functional class II. Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
PMS-BOSENTAN	02383012	62.5 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-BOSENTAN	02383020	125 MG	TABLET · ORAL	PHARMASCIENCE INC
TARO-BOSENTAN	02483130	62.5 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-BOSENTAN	02483149	125 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TRACLEER	02244981	62.5 MG	TABLET · ORAL	JANSSEN INC
TRACLEER	02244982	125 MG	TABLET · ORAL	JANSSEN INC

Safety signals and safety-related labeling changes

US FDA 5 Nov 2025 TRACLEER — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 5 Nov 2025 TRACLEER — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bosentan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.