Pirfenidone
Other Immunosuppressants
Sold as ESBRIET
- Drug class
- Other Immunosuppressants
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 78
- FDA reports (12 mo)
- 950
Overview
Plain-language summary, compiled from the cited regulatory records
Pirfenidone is a medication classified as an immunosuppressant [1]. It is approved for the treatment of idiopathic pulmonary fibrosis (IPF) [1].
In the past 12 months, there have been 950 adverse event reports associated with pirfenidone [2]. The most frequently reported adverse events include death, dyspnoea, cough, nausea, and diarrhoea [2].
Pirfenidone is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 51 | May 15, 2026 |
| CA Canada | Health Canada | 18 | May 22, 2026 |
| US United States | FDA | 6 | January 14, 2026 |
| EU European Union | EMA | 3 | May 8, 2026 |
GBUnited Kingdom· MHRA
51 products
Uses
Pirfenidone is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
How to take
CACanada· Health Canada
18 products
Uses
ESBRIET® (pirfenidone) is indicated for treatment of idiopathic pulmonary fibrosis (IPF) in adults. 1.
Pediatrics Pediatrics (<18 years of age):
The safety and effectiveness of ESBRIET in pediatric patients have not been established. 2. Geriatrics No dose adjustment is necessary in patients 65 years and older (see 10 CLINICAL PHARMACOLOGY).
How to take
USUnited States· FDA
6 products
Uses
1 INDICATIONS AND USAGE Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF). (1)
How to take
EUEuropean Union· EMA
3 products
Uses
Esbriet is indicated in adults for the treatment of idiopathic pulmonary fibrosis (IPF).
How to take
Drug interactions
Known interactions involving Pirfenidone. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL232180219 · revised February 20, 2026
- [2]Health Canada (DPD) · 02464489 · revised March 22, 2025
- [3]FDA DailyMed · 07ff87b3-0a88-15… · revised January 14, 2026 [PDF]
- [4]European Medicines Agency · EMEA/H/C/002154 · revised May 8, 2026
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.