An updated safety review of the drug treatments for idiopathic pulmonary fibrosis

Research output: Contribution to journalEditorial


Introduction The approval of antifibrotic agents nintedanib and pirfenidone revolutionized the management of idiopathic pulmonary fibrosis (IPF). These treatments showed acceptable tolerability in randomized-clinical trials; however, they have been associated with a spectrum of potential side effects which require careful assessment of risks and benefits in the individual patient before commencing and during antifibrotic therapy. Areas covered The accrued evidence on safety of nintedanib and pirfenidone is summarized, from the first randomized clinical trials to the open-label extension studies and post-marketing clinical experiences which helped clarify the long-term tolerability of these drugs. Expert opinion The data collected over the last years confirmed the comparable tolerability profile of nintedanib and pirfenidone. The physician's assessment of expected side effects may help decide the optimal first-line therapy for the individual patient. Patient's counseling during treatment remains essential to manage emerging adverse events and eventually inform the decision of drug discontinuation.
Original languageEnglish
Pages (from-to)1035-1048-1048
JournalExpert Opinion on Drug Safety
Publication statusPublished - 2021


  • Anti-Inflammatory Agents, Non-Steroidal
  • Humans
  • Idiopathic Pulmonary Fibrosis
  • Idiopathic pulmonary fibrosis
  • Indoles
  • Patient Education as Topic
  • Protein Kinase Inhibitors
  • Pyridones
  • Randomized Controlled Trials as Topic
  • nintedanib
  • pirfenidone
  • safety
  • tolerability


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