Esbriet

Authorised

Human

Details

EMA number	EMEA/H/C/002154
ATC code	L04AX05
Authorisation	28 February 2011
Revision	38

EMA page

Therapeutic indication

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

MeSH: Idiopathic Pulmonary Fibrosis;Lung Diseases;Respiratory Tract Diseases

Group: Immunosuppressants

Active substances

Pirfenidone

Marketing Authorisation Holder

H.A.C. Pharma

MAH

🇺🇸 Also approved in the US (FDA)

ESBRIET — LEGACY, approved 2023-02-24 (NDA208780).

Most reported adverse events (US / FAERS)

42,505 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

7,474

nausea

5,151

fatigue

3,792

decreased appetite

3,248

diarrhoea

Timeline

Filter by authority:

Esbriet authorised

28 Feb 2011

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

ESBRIET — LEGACY, approved 2023-02-24 (NDA208780).

Most reported adverse events (US / FAERS)

42,505 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

death

7,474

nausea

5,151

fatigue

3,792

decreased appetite

3,248

diarrhoea

3,234

dyspnoea

2,917

weight decreased

2,214

dizziness

2,167

rash

2,034

cough

2,020

vomiting

1,803

pneumonia

1,769

abdominal discomfort

1,678

abdominal pain upper

1,506

headache

1,498