pirfenidone
Esbriet · ATC code L04AX05
Also known as: Pirfenidon · Brand names: Esbriet, Pirfenidon Accord, Pirfenidon Actavis, Pirfenidon Ratiopharm, Equitor, Pirfenair, Pirfenidon Al, Pirfenidon Amarox, Pirfenidon Axiromed, Pirfenidon Axunio, Pirfenidon Beta, Pirfenidon Cipla, Pirfenidon Glenmark, Pirfenidon Hormosan, Pirfenidon Intas …
- Key facts
- Active substance
- pirfenidone
- Drug class
- Immunosuppressive drug
- ATC code
- L04AX05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Esbriet 267 mg film-coated tablets / Esbriet 534 mg film-coated tablets / Esbriet 801 mg film-coated tablets
- Marketing authorisation holder
- H.A.C. Pharma
- Information as of
- 2026-10-27
Key facts
Pirfenidone (Esbriet) is an oral medicine used to treat idiopathic pulmonary fibrosis (IPF) in adults.
What it is used for
- Idiopathic pulmonary fibrosis (IPF) in adults
Dosing
- Titrate over 14 days: days 1 to 7 267 mg three times a day, days 8 to 14 534 mg three times a day, day 15 onward 801 mg three times a day
- Maintenance 801 mg three times a day with food (2403 mg/day); higher doses not recommended
- After missing 14 consecutive days or more, re-titrate
- For GI intolerance, photosensitivity or transaminase elevation, reduce or interrupt per the product information
- No dose adjustment in patients 65 years and older
Contraindications
- Hypersensitivity to the active substance or excipients; history of angioedema with pirfenidone
- Concomitant fluvoxamine
- Severe hepatic impairment or end-stage liver disease
- Severe renal impairment (CrCl <30 ml/min) or end-stage renal disease requiring dialysis
Important warnings
- Elevated transaminases are common; test liver function before starting, monthly for the first 6 months, then every 3 months
- Severe drug-induced liver injury, including isolated fatal cases, has been reported
- Photosensitivity and rash: use sunblock daily and avoid sun exposure
Side effects
- Most frequent: nausea (32.4%), rash (26.2%), decreased appetite (20.7%), diarrhoea (18.8%), fatigue (18.5%), dyspepsia (16.1%)
- Headache (10.1%), photosensitivity reaction (9.3%)
- Very common upper respiratory tract infection; common urinary tract infection
Interactions
- Pirfenidone is mainly metabolised via CYP1A2
- Fluvoxamine (strong CYP1A2 inhibitor) greatly increases exposure and is contraindicated
- Avoid grapefruit juice during treatment
Pregnancy and breastfeeding
- No data in pregnant women; as a precaution, preferable to avoid in pregnancy
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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
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)
- EsbrietH.A.C. Pharma · EMEA/H/C/002154
- Pirfenidone axunio (previously Pirfenidone AET) · genericAxunio Pharma GmbH · EMEA/H/C/005873
- Pirfenidone Viatris · genericViatris Limited · EMEA/H/C/005862
Source: European Medicines Agency (EMA), product information
Austria
- Pirfenidon AccordAccord Healthcare B.V. · 1 register entry
- Pirfenidon ActavisActavis Group Ptc Ehf. · 1 register entry
- Pirfenidon RatiopharmRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- EquitorStada Arzneimittel Ag · 1 register entry
- PirfenairHexal Ag · 1 register entry
- Pirfenidon AccordAccord Healthcare B.V. · 1 register entry
- Pirfenidon AlAliud Pharma Gmbh · 1 register entry
- Pirfenidon AmaroxAmarox Pharma Gmbh · 1 register entry
- Pirfenidon AxiromedMedical Valley Invest Ab · 2 register entries
- Pirfenidon AxunioAxunio Pharma Gmbh · 1 register entry
- Pirfenidon BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Pirfenidon CiplaCipla Europe Nv · 1 register entry
- Pirfenidon GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Pirfenidon HormosanHormosan Pharma Gmbh · 1 register entry
- Pirfenidon IntasIntas Third Party Sales 2005, S.L. · 1 register entry
Show all 18 brand names
- Pirfenidon PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
- Pirfenidon RatiopharmRatiopharm Gmbh · 1 register entry
- Pirfenidon StadaStadapharm Gmbh · 1 register entry
- Pirfenidon UmedicaUmedica Netherlands B.V · 1 register entry
- Pirfenidon VivantaVivanta Generics S.R.O. · 1 register entry
- Pirfenidon ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- EsbrietROCHE MÜSTAHZARLARI SAN.A.Ş. · 2 register entries
- MontenidonMONTERO İLAÇ VE GIDA SAN. VE TİC. A.Ş. · 2 register entries
- PirfaALİ RAİF İLAÇ SAN. A.Ş. · 3 register entries
- PirfectNOBEL İLAÇ SAN. VE TİC. A.Ş. · 5 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Perfenidon Eg, Pirfenidon Cipla, Pirfenidon Eg, Pirfenidone Ab, Pirfenidone Accord
- Bulgaria
- Fredalix
- Croatia
- Pirfenidon Accord, Pirfenidon Sandoz, Pirfenidon Teva, Pirfenidone Accord, Pirfenidone Msn
- Cyprus
- Pirfenidone Accord, Pirfenidone Msn, Pirfenidone Tecnigen
- Czechia
- Fredalix, Pirfenidon Zentiva, Pirfenidone Accord, Pirfenidone Msn, Pirfenidone Teva, Pirfenidone Umedica
- Denmark
- Fredalix, Pirfenair, Pirfenidon Medical Valley, Pirfenidon Teva, Pirfenidon Zentiva, Pirfenidone "sandoz", Pirfenidone Accord, Pirfenidone Glenmark, Pirfenidone Newbury, Pirfenidone Stada
- Estonia
- Pirfenidone Accord, Pirfenidone Msn, Pirfenidone Teva, Pirfenidone Zentiva
- Finland
- Pirfenidon Cipla, Pirfenidone Accord, Pirfenidone Glenmark, Pirfenidone Ratiopharm, Pirfenidone Sandoz, Pirfenidone Stada
- France
- Pirfenidon Eg Labo - Laboratoireseurogenerics, Pirfenidone Accord, Pirfenidone Arrow, Pirfenidone Biogaran, Pirfenidone Cipla, Pirfenidone Eg, Pirfenidone Sandoz, Pirfenidone Teva, Pirfenidone Zentiva, Pirfenidone Zydus
- Greece
- Orepir, Pirfenidone Accord, Pirfenidone Sandoz, Pirfenidone Teva
- Hungary
- Pirfenidon Zentiva
- Iceland
- Esbriet, Pirfenidon Medical Valley, Pirfenidon Teva, Pirfenidon Zentiva, Pirfenidone Viatris
- Ireland
- Pirfenidone Accord, Pirfenidone Axunio, Pirfenidone Cipla, Pirfenidone Clonmel, Pirfenidone Msn, Pirfenidone Rowex, Pirfenidone Teva
- Italy
- Blamonehel, Pirfenidone Accord, Pirfenidone Aurobindo, Pirfenidone Cipla, Pirfenidone Dr. Reddy’s, Pirfenidone Eg, Pirfenidone Sandoz, Pirfenidone Tecnigen, Pirfenidone Teva, Pirfenidone Zentiva
- Latvia
- Pirfenidone Accord, Pirfenidone Msn, Pirfenidone Teva, Pirfenidone Umedica, Pirfenidone Zentiva
- Liechtenstein
- Esbriet, Pirfenidone Viatris
- Lithuania
- Pirfenidone Accord, Pirfenidone Msn, Pirfenidone Teva, Pirfenidone Zentiva
- Luxembourg
- Pirfenidon Eg
- Malta
- Pirfenidone Clonmel, Pirfenidone Msn
- Netherlands
- Pirfenidon Accord, Pirfenidon Amarox, Pirfenidon Axunio, Pirfenidon Glenmark, Pirfenidon Msn, Pirfenidon Sandoz, Pirfenidon Teva, Pirfenidon Vivanta, Pirfenidon Xiromed, Pirfenidone Aurobindo
- Norway
- Esbriet, Pirfenidon Cipla, Pirfenidon Koanaa, Pirfenidon Medical Valley, Pirfenidon Teva, Pirfenidon Zentiva, Pirfenidone Accord, Pirfenidone Glenmark, Pirfenidone Koanaa, Pirfenidone Newbury, Pirfenidone Sandoz, Pirfenidone Stada, Pirfenidone Viatris, Pirfenidone Vivanta
- Poland
- Pirfenidon Cipla Europe, Pirfenidon Medical Valley, Pirfenidon Msn, Pirfenidon Stada, Pirfenidon Zentiva, Pirfenidone Accord, Pirfenidone Aurovitas, Pirfenidone Sandoz
- Portugal
- Pirfenidona Accord, Pirfenidona Generis, Pirfenidona Pentafarma, Pirfenidona Sandoz, Pirfenidona Tecnigen, Pirfenidona Teva, Pirfenidona Vivanta
- Romania
- Pirfenidon Msn
- Slovakia
- Pirfenidone Msn, Pirfenidón Accord
- Slovenia
- Pirfenidon Accord, Pirfenidon Teva
- Spain
- Pirfenidona Accord, Pirfenidona Aurovitas, Pirfenidona Cipla, Pirfenidona Dr. Reddys, Pirfenidona Glenmark, Pirfenidona Kern Pharma, Pirfenidona Sandoz, Pirfenidona Tarbis, Pirfenidona Tecnigen, Pirfenidona Teva, Pirfenidona Umedica, Pirfenidona Vivanta, Pirfenidona Zentiva
- Sweden
- Pirfenidon Cipla, Pirfenidon Medical Valley, Pirfenidon Teva, Pirfenidon Zentiva, Pirfenidone Accord, Pirfenidone Glenmark, Pirfenidone Newbury, Pirfenidone Sandoz, Pirfenidone Stada, Pirfenidone Vivanta
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Esbriet – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/esbriet-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. 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
- Wikidata (CC0): ATC L04AX.
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.