Drug updated on 4/16/2024

Dosage FormCapsule (oral: 267 mg); Tablet (oral: 267 mg, 801 mg)
Drug ClassPyridones
Ongoing and
Completed Studies


  • Indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

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  • Pirfenidone (Esbriet) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF), demonstrating a lower incidence of serious adverse events compared to placebo and other treatments such as warfarin, which showed higher all-cause mortality.
  • Studies focused on antifibrotic medications like pirfenidone and nintedanib.
  • Adverse reactions are significant with combination therapy involving pirfenidone; these include gastrointestinal issues leading to treatment discontinuation in some cases. Additionally, photosensitivity was noted, requiring careful patient selection.
  • In comparison with other drugs used for IPF treatment, pirfenidone consistently showed statistically significant improvement in preserving forced vital capacity (FVC), indicating a slower decline in lung function among patients suffering from IPF or non-IPF fibrosing interstitial lung diseases (ILDs).
  • Studies suggest that antifibrotic treatments including pirfenidone can decrease risk factors such as all-cause mortality and acute exacerbations, improving overall outcomes.
  • For patients with progressive pulmonary fibrosis, the use of pirfenidone resulted in significantly decreased disease progression while protecting lung function, emphasizing its efficacy.
  • The effectiveness extends beyond just IPFs; a study highlighted the benefit for patients with rheumatoid arthritis-associated ILD from the reduction in disease progression offered by antifibrotics like pirfenidone.
  • A cost-effectiveness analysis suggested that N-acetylcysteine combined with Pirfenidone might be the most cost-effective option, considering quality-adjusted life years, despite the need for more clinical trials to solidify its application.

Product Monograph / Prescribing Information

Document TitleYearSource
Esbriet (pirfenidone) prescribing information.2023Genentech USA, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A comprehensive comparison of the safety and efficacy of drugs in the treatment of idiopathic pulmonary fibrosis: A network meta-analysis based on randomized controlled trials.2024BioMed Central Pulmonary Medicine
A comparison of the effectiveness of nintedanib and pirfenidone in treating idiopathic pulmonary fibrosis: A systematic review. 2024Cureus
Impact of antifibrotic therapy on disease progression, all-cause mortality, and risk of acute exacerbation in non-IPF fibrosing interstitial lung diseases: Evidence from a meta-analysis of randomized controlled trials and prospective controlled studies.2024Therapeutic Advances in Respiratory Disease
Safety and tolerability of combination treatment with pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: A systematic review and meta-analysis. 2023Journal of Thoracic Disease
Efficacy of pirfenidone and nintedanib in interstitial lung diseases other than idiopathic pulmonary fibrosis: A systematic review.2023International Journal of Molecular Sciences
Drug therapies for treatment of idiopathic pulmonary fibrosis: A systematic review, Bayesian network meta-analysis, and cost-effectiveness analysis.2023EClinicalMedicine
Antifibrotic agents in rheumatoid arthritis-associated interstitial lung disease: A systematic review and meta-analysis. 2023Life
Pirfenidone in progressive pulmonary fibrosis: A systematic review and meta-analysis.2022Annals of the American Thoracic Society
Efficacy and safety of pirfenidone in the treatment of idiopathic pulmonary fibrosis patients: A systematic review and meta-analysis of randomised controlled trials. 2021BMJ open
Efficacy of antifibrotic drugs, nintedanib and pirfenidone, in treatment of progressive pulmonary fibrosis in both idiopathic pulmonary fibrosis (IPF) and non-IPF: A systematic review and meta-analysis.2021BMC Pulmonary Medicine
Impact of antifibrotic therapy on mortality and acute exacerbation in idiopathic pulmonary fibrosis: A systematic review and meta-analysis.2021Chest
Systematic review and meta-analysis of pirfenidone, nintedanib, and pamrevlumab for the treatment of idiopathic pulmonary fibrosis.2021Annals of Pharmacotherapy
Systematic review and network meta-analysis of approved medicines for the treatment of idiopathic pulmonary fibrosis.2019Journal of Drug Assessment

Clinical Practice Guidelines

Document TitleYearSource
Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults.2022American Journal of Respiratory and Critical Care Medicine