Is Pirfenidone registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 9 valid registrations of Pirfenidone, including Donfer (801 mg, Film-coated tablet, SAR 5717.25); Donfer (267 mg, Film-coated tablet, SAR 3984.85); ESBRIET 267 MG FILM COATED TABLET (267 mg, Film-coated tablet, SAR 2081.20); ESBRIET 267 mg HARD CAPSULES (267 mg, Capsule, hard, SAR 7342.55); ESBRIET 801 MG FILM COATED TABLET (801 mg, Film-coated tablet, SAR 6241.20).

Is Pirfenidone approved by the US FDA?

Drugs@FDA lists 26 application product lines for Pirfenidone, including ESBRIET (Prescription); ESBRIET (Prescription); PIRFENIDONE (Prescription); PIRFENIDONE (Prescription); PIRFENIDONE (Prescription).

Is Pirfenidone authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Pirfenidone: Esbriet, Pirfenidone axunio (previously Pirfenidone AET), Pirfenidone Viatris.

Are there safety signals or safety updates for Pirfenidone?

EMA PRAC: 7 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2024-04-11).

Active substance

Pirfenidone

SFDA 9
US FDA 26
EMA 3
Health Canada 12
US price lines 2
Safety 10

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Donfer	801 mg	Film-coated tablet · Oral use	210 Blister	SAR 5717.25	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Donfer	267 mg	Film-coated tablet · Oral use	210 Blister	SAR 3984.85	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
ESBRIET 267 MG FILM COATED TABLET	267 mg	Film-coated tablet · Oral use	90 Bottle	SAR 2081.20	NCE · Prescription	ROCHE	Valid
ESBRIET 267 mg HARD CAPSULES	267 mg	Capsule, hard · Oral use	270 Bottle	SAR 7342.55	NCE · Prescription	ROCHE	Valid
ESBRIET 801 MG FILM COATED TABLET	801 mg	Film-coated tablet · Oral use	90 Bottle	SAR 6241.20	NCE · Prescription	ROCHE	Valid
Fenido	267 mg	Film-coated tablet · Oral use	90 Blister	SAR 2170.35	Generic · Prescription	Boston Oncology Arabia	Valid
Fenido	801 mg	Film-coated tablet · Oral use	90 Blister	SAR 6285.70	Generic · Prescription	Boston Oncology Arabia	Valid
PIRDONE	267 mg	Film-coated tablet · Oral use	100 Blister	SAR 2175.55	Generic · Prescription	Saudi Amarox	Valid
Pirfenidone Actavis	267 mg	Film-coated tablet · Oral use	63 Blister	SAR 1200.60	Generic · Prescription	Ratiopharm GmbH	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
ESBRIET	267MG	capsule · oral	LEGACY	Prescription	15 Oct 2014
ESBRIET	267MG; 801MG	tablet · oral	LEGACY	Prescription	11 Jan 2017
PIRFENIDONE	267MG	capsule · oral	AMNEAL	Prescription	3 Jan 2022
PIRFENIDONE	267MG	capsule · oral	ACCORD HLTHCARE	Prescription	20 Jan 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	ACCORD HLTHCARE	Prescription	25 Jan 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	TEVA PHARMS USA	Prescription	25 Jan 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	AMNEAL	Prescription	25 Mar 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	SANDOZ	Prescription	28 Apr 2022
PIRFENIDONE	267MG; 801MG; 534MG	tablet · oral	MICRO LABS	Prescription	18 May 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	ALEMBIC	Prescription	20 May 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	MSN	Prescription	24 May 2022
PIRFENIDONE	267MG	capsule · oral	SANDOZ	Prescription	13 Jun 2022
PIRFENIDONE	267MG; 534MG; 801MG	tablet · oral	LAURUS	Prescription	19 Jul 2022
PIRFENIDONE	267MG	capsule · oral	LAURUS	Prescription	19 Jul 2022
PIRFENIDONE	267MG; 534MG; 801MG	tablet · oral	AIZANT	Prescription	21 Jul 2022
PIRFENIDONE	267MG	capsule · oral	SCIEGEN PHARMS	Prescription	1 Aug 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	SCIEGEN PHARMS	Prescription	1 Aug 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	HETERO LABS LTD V	Prescription	21 Sep 2022
PIRFENIDONE	267MG; 801MG	tablet · oral	APOTEX	Prescription	31 May 2023
PIRFENIDONE	267MG	capsule · oral	MACLEODS PHARMS	Prescription	18 Dec 2024
PIRFENIDONE	267MG; 801MG	tablet · oral	AUROBINDO PHARMA	Prescription	11 Aug 2025
PIRFENIDONE	267MG	capsule · oral	AUROBINDO PHARMA	Prescription	20 Apr 2026
ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	LEGACY	Discontinued	11 Jan 2017
PIRFENIDONE	267MG	capsule · oral	APOTEX	Discontinued	9 Jun 2023
PIRFENIDONE	267MG; 801MG	tablet · oral	CHARTWELL RX	Discontinued	23 Aug 2023

1 more — full table

EMA European Union — centrally authorised medicines

Esbriet H.A.C. Pharma · Authorised · authorised 28 Feb 2011 · ATC L04AX05

Therapeutic indication (EMA)

Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis.

Pirfenidone axunio (previously Pirfenidone AET) Axunio Pharma GmbH · Authorised · authorised 20 Jun 2022 · ATC L04AX05

Therapeutic indication (EMA)

Pirfenidone AET is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

Pirfenidone Viatris Viatris Limited · Authorised · authorised 10 Jan 2023 · ATC L04AX05

Therapeutic indication (EMA)

Pirfenidone Viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-PIRFENIDONE	02537753	267 MG	TABLET · ORAL	AURO PHARMA INC
AURO-PIRFENIDONE	02537761	801 MG	TABLET · ORAL	AURO PHARMA INC
ESBRIET	02464489	267 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED
ESBRIET	02464500	801 MG	TABLET · ORAL	HOFFMANN-LA ROCHE LIMITED
JAMP PIRFENIDONE	02509938	267 MG	CAPSULE · ORAL	JAMP PHARMA CORPORATION
JAMP PIRFENIDONE	02514702	267 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP PIRFENIDONE	02514710	801 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-PIRFENIDONE	02550644	267 MG	TABLET · ORAL	MANTRA PHARMA INC
M-PIRFENIDONE	02550652	801 MG	TABLET · ORAL	MANTRA PHARMA INC
SANDOZ PIRFENIDONE CAPSULES	02488833	267 MG	CAPSULE · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ PIRFENIDONE TABLETS	02488507	267 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ PIRFENIDONE TABLETS	02488515	801 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	PIRFENIDONE 267 MG TABLET	$0.68549	per EA	23 Sep 2026
US NADAC	PIRFENIDONE 801 MG TABLET	$1.96184	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

EMA PRAC 11 Apr 2024 PRAC signal: Lichenoid drug eruption
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2023 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes
EMA PRAC 12 May 2023 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
US FDA 24 Feb 2023 ESBRIET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 24 Feb 2023 ESBRIET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
MHRA 16 Nov 2020 Pirfenidone (Esbriet): risk of serious liver injury; updated advice on liver function testing
Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin levels before starting pirfenidone treatment, monthly for the first 6 months of treatment, and then every 3 months thereafter. Follow new guidance on testing liver function promptly in patients who report symptoms or have clinical signs that might indicate they have liver injury and adjust the dose or discontinue treatment according to new recommendations.
EMA PRAC 15 Mar 2019 PRAC signal: Herpes viral infections
Action for MAH: update of the product information: No
EMA PRAC 15 Mar 2019 PRAC signal: Hyponatraemia
Action for MAH: update of the product information: No
EMA PRAC 5 May 2017 PRAC signal: Colitis
Action for MAH: update of the product information: No
EMA PRAC 1 Dec 2016 PRAC signal: Colitis
Action for MAH: update of the product information: No

All safety entries for pirfenidone →

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.