Pirfenidone

DRUG INFORMATION

  ADULT
    - • Take with food. • Recommended dosage: 801 mg three times daily (2403 mg/day).
      Source: US FDA label for pirfenidone (Pirfenidone), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2 ) • Upon initiation of treatment, titrate to the full dosage of 2403 mg/day
      over a 14-day period as follows: Treatment days Dosage Days 1 through 7 267 mg
      three times daily (801 mg/day) Days 8 through 14 534 mg three times daily (1602
      mg/day) Days 15 onward 801 mg three times daily (2403 mg/day) • Consider temporary
      dosage reduction, treatment interruption, or discontinuation for management of
      adverse reactions.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.1 ) 2.1 Testing Prior to Pirfenidone Capsules Administration Conduct liver
      function tests prior to initiating treatment with pirfenidone capsules [ see
      Warnings and Precautions (5.1) ]. 2.2 Recommended Dosage The recommended daily
      maintenance dosage of pirfenidone capsules are 801 mg three times daily for a
      total of 2403 mg/day.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Safety and effectiveness of pirfenidone in pediatric patients have not been
      established.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 8.6 , 12.3 ) • Renal Impairment: Monitor for adverse reactions and consider
      dosage modification or discontinuation of pirfenidone as needed.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - Pirfenidone is not recommended for use in patients with end stage renal disease on
      dialysis.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - Pirfenidone is not recommended for use in patients with severe (Child Pugh Class
      C) hepatic impairment [see Clinical Pharmacology ( 12.3 )] . 8.7 Renal Impairment
      Pirfenidone should be used with caution in patients with mild (CL cr 50 to 80
      mL/min), moderate (CL cr 30 to 50 mL/min), or severe (CL cr less than 30 mL/min)
      renal impairment [see Clinical Pharmacology ( 12.3 )].
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - • Hepatic Impairment: Monitor for adverse reactions and consider dosage
      modification or discontinuation of pirfenidone as needed.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - Pirfenidone is not recommended for use in patients with severe hepatic impairment.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - No dosage adjustment is required based upon age. 8.6 Hepatic Impairment
      Pirfenidone should be used with caution in patients with mild (Child Pugh Class A)
      to moderate (Child Pugh Class B) hepatic impairment.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The data with pirfenidone use in pregnant women are insufficient to
      inform on drug associated risks for major birth defects and miscarriage.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, pirfenidone was not teratogenic in rats and
      rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended
      daily dose (MRDD) in adults [see Data ] .
      Source: US FDA label for pirfenidone (Pirfenidone), section 'pregnancy', retrieved
      2026-08-29
    - In the U.S. general population, the estimated background risk of major birth
      defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to
      20%, respectively.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - In a pre- and post-natal development study, female rats received pirfenidone at
      oral doses of 0, 100, 300, and 1000 mg/kg/day from GD 7 to lactation day 20.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - Prolongation of the gestation period, decreased numbers of live newborn, and
      reduced pup viability and body weights were seen in rats at an oral dosage
      approximately 3 times the MRDD in adults (on a mg/m 2 basis at a maternal oral
      dose of 1000 mg/kg/day). 8.2 Lactation Risk Summary No information is available on
      the presence of pirfenidone in human milk, the effects of the drug on the
      breastfed infant, or the effects of the drug on milk production.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29
    - The lack of clinical data during lactation precludes clear determination of the
      risk of pirfenidone to an infant during lactation; therefore, the developmental
      and health benefits of breastfeeding should be considered along with the mother's
      clinical need for pirfenidone and the potential adverse effects on the breastfed
      child from pirfenidone or from the underlying maternal condition.
      Source: US FDA label for pirfenidone (Pirfenidone), section 'use in specific
      populations', retrieved 2026-08-29