Table 2.

Adverse events associated with pirfenidone therapya

StudyAdverse Event
GastrointestinalSedation or FatiguePhotosensitivity Dermatitis
This study (n = 21)8/21 (38%)6/21 (29%)2/21 (10%)
Other studies (n = 41) (19,36,37)46%27%12%
  • a The presence of gastrointestinal adverse events (dyspepsia, nausea), sedation or fatigue, or photosensitivity dermatitis at any time during pirfenidone therapy in this study. For comparison, the rates of adverse events are provided for other clinical studies (19,36,37), excluding those that used a higher pirfenidone dosage or studied patients with advanced liver disease, which is expected to impair pirfenidone metabolism.