Antifibrotic agents
ATC code: L04AX05 (Pirfenidone)
Brand names
Pirfenidona Sandoz, Esbriet, Pirfenidona Stada, Pirfenidona Cinfa
A small molecule with combined antifibrotic, anti-inflammatory, and antioxidant action. Suppresses fibroblast proliferation and collagen synthesis by inhibiting TGF-β signaling. Reduces TNF-α, IL-1β, IL-6 production. Exact mechanism not fully established, but clinical effect confirmed in RCTs.
First line
First-line IPF therapy per ATS/ERS/JRS/ALAT 2022 and Spanish SEPAR 2023 – on par with nintedanib. Dose 801 mg three times daily (2403 mg/day) with meals. Titration: 267 mg three times daily in week 1, double in week 2, full dose by week 3. CAPACITY-1, CAPACITY-2, ASCEND (NEJM 2014) reduced FVC decline by 50%. Duration – lifelong until intolerance or transplantation.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Pirfenidone is an antifibrotic drug with anti-inflammatory action. It is prescribed only for idiopathic pulmonary fibrosis (AEMPS Ficha Técnica, ASCEND 2014). In alt-anti-aging circles, pirfenidone is occasionally promoted as an antifibrotic for anti-aging of the lungs and other tissues in healthy people. In healthy adults, no clinical studies of such use exist. The drug has serious risks: severe photosensitivity (skin reactions in sunlight), GI disturbances (nausea, vomiting, diarrhea, weight loss), hepatotoxicity (requires regular liver enzyme monitoring), and elevated cardiovascular event risk. If pirfenidone was recommended to a healthy person, seek a second opinion immediately.
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No human pregnancy data. Animal studies show fetal toxicity at high doses. Barrier contraception throughout therapy.
Milk excretion not studied. Discontinue breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Pirfenidone is evaluated for the following indications with varying evidence strength: Idiopathic pulmonary fibrosis (evidence tier A), Anti-aging and longevity (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Pirfenidone (≥ 1 in 100): Nausea, Anorexia and weight loss, Sun-related skin reaction (photodermatitis), Fatigue, Diarrhea, ALT/AST elevation. See the Safety section for uncommon and serious reactions.
FDA category C. No human pregnancy data. Animal studies show fetal toxicity at high doses. Barrier contraception throughout therapy.
Milk excretion not studied. Discontinue breastfeeding.
Pirfenidone is contraindicated in: Hypersensitivity; Fluvoxamine combination; Severe hepatic impairment Child-Pugh C; Severe renal impairment (eGFR <30 mL/min); Pregnancy. Full list in the Safety section.