FDA label
What is pirfenidone used for?
The FDA-approved uses of pirfenidone, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).”
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Pirfenidone, tablet, film coated
Indications and Usage, quoted from the label by Laurus Labs Limited (ANDA212722). Cross-references to other label sections are left out.
Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Source: DailyMed label, set id 29b0fd0e-5a2b-4da7-8524-177dc28bf55e, version 4, effective July 22, 2025. NDC 42385-924, one of 27 listings for this product.
Questions
What is pirfenidone used for?
The FDA label says: “Pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).”
What drug class is pirfenidone?
FDA lists pirfenidone in the Pyridone established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.