Pirfenidone

INN (International Nonproprietary Name)

🇺🇸 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

Medicines containing this active substance

3 medicines

Pirfenidone axunio (previously Pirfenidone AET)

Authorised

🇺🇸 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