Antifibrotic agents
Brand names: Pirfenidona Sandoz, Esbriet, Pirfenidona Stada, Pirfenidona Cinfa
Updated · Methodology
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.
Sources
ICD-10: J84.1 · ICD-11: CB03.4
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.
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.
AEMPS summary of product characteristics (section 4.6): there are no data on pirfenidone use in pregnant women. In animals, pirfenidone or its metabolites cross the placenta and may accumulate in the amniotic fluid; in rats given high doses (1,000 mg/kg a day or more), gestation was prolonged and fetal viability was reduced. As a precaution, pirfenidone is best avoided during pregnancy.
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 broken down mainly by CYP1A2, and the Esbriet SmPC links grapefruit juice to inhibition of this enzyme. More pirfenidone in the blood means more nausea, loss of appetite, sun sensitivity and raised liver enzymes. The SmPC says to avoid grapefruit juice during treatment.
Source: EMA: Ficha técnica de Esbriet 267 mg comprimidos recubiertos con película (pirfenidona) (2026)
Verbatim lines from the interaction sections, in the language of the label
«uso concomitante de fluvoxamina (ver sección 4.5),»AEMPS, section 4.3 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: La administración conjunta de pirfenidona y 750 mg de ciprofloxacino (un inhibidor moderado del CYP1A2) aumentó la exposición a pirfenidona en un 81%. Si no se…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of…»FDA, section 7 · Open on DailyMed
«CYP1A2 Inhibitors: Pirfenidone is metabolized primarily (70 to 80%) via CYP1A2 with minor contributions from other CYP isoenzymes including CYP2C9, 2C19, 2D6 and 2E1. Strong CYP1A2 Inhibitors The…»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of…»FDA, section 7 · Open on DailyMed
«Fluvoxamina e inhibidores del CYP1A2: Pirfenidona está contraindicado en pacientes que estén tomando también fluvoxamina (ver sección 4.3). Debe suspenderse el tratamiento con fluvoxamina antes de…»AEMPS, section 4.5 · Open on CIMA
«Tabaco e inductores de CYP1A2: La administración simultánea de otros medicamentos que actúan como inductores potentes tanto de CYP1A2 como de las otras isoenzimas CYP que intervienen en el…»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Pirfenidona debe utilizarse con precaución en pacientes tratados con otros inhibidores moderados de CYP1A2 (p.ej. amiodarona o propafenona).»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Se recomienda especial precaución cuando se administren inhibidores de CYP1A2 conjuntamente con inhibidores potentes de una o más de las otras isoenzimas CYP que…»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Se recomienda especial precaución cuando se administren inhibidores de CYP1A2 conjuntamente con inhibidores potentes de una o más de las otras isoenzimas CYP que…»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Se recomienda especial precaución cuando se administren inhibidores de CYP1A2 conjuntamente con inhibidores potentes de una o más de las otras isoenzimas CYP que…»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Se recomienda especial precaución cuando se administren inhibidores de CYP1A2 conjuntamente con inhibidores potentes de una o más de las otras isoenzimas CYP que…»AEMPS, section 4.5 · Open on CIMA
«Fluvoxamina e inhibidores del CYP1A2: Pirfenidona debe utilizarse con precaución en pacientes tratados con otros inhibidores moderados de CYP1A2 (p.ej. amiodarona o propafenona).»AEMPS, section 4.5 · Open on CIMA
«Tabaco e inductores de CYP1A2: El uso concomitante de inductores moderados de CYP1A2 (como omeprazol) puede, en teoría, reducir las concentraciones plasmáticas de pirfenidona.»AEMPS, section 4.5 · Open on CIMA
«Pirfenidone: In a multiple-dose study conducted to assess the pharmacokinetic effects of concomitant treatment with nintedanib and pirfenidone, the coadministration of nintedanib with pirfenidone did…»FDA, section 7 · Open on DailyMed
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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.
AEMPS summary of product characteristics (section 4.6): there are no data on pirfenidone use in pregnant women. In animals, pirfenidone or its metabolites cross the placenta and may accumulate in the amniotic fluid; in rats given high doses (1,000 mg/kg a day or more), gestation was prolonged and fetal viability was reduced. As a precaution, pirfenidone is best avoided during pregnancy.
Milk excretion not studied. Discontinue breastfeeding.
Alcohol raises hepatotoxicity risk.
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.
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