{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "pirfenidone",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• 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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "( 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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "• 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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/pirfenidone.json",
        "verbatim": true
      }
    ]
  }
}