{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "leflunomide",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Loading dosage for patients at low risk for leflunomide tablets-associated hepatotoxicity and leflunomide tablets-associated myelosuppression: 100 mg daily for 3 days.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Maintenance dosage: 20 mg daily.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) Maximum recommended daily dosage: 20 mg once daily.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of leflunomide in pediatric patients have not been established. The safety and effectiveness of leflunomide in the treatment of polyarticular course juvenile idiopathic arthritis (JIA) was evaluated in a single multicenter, double-blind, active-controlled trial in 94 pediatric patients (1:1 randomization) with polyarticular course juvenile idiopathic arthritis (JIA) as defined by the American College of Rheumatology (ACR).",
        "source": "US FDA label for leflunomide (Leflunomide), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. 8.7 Renal Impairment Dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No dosage adjustment is needed in patients over 65. 8.6 Hepatic Impairment Dedicated studies of the effect of hepatic impairment on leflunomide pharmacokinetics have not been conducted.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Given the need to metabolize leflunomide into the active species, the role of the liver in drug elimination/recycling, and the possible risk of increased hepatic toxicity, the use of leflunomide in patients with hepatic impairment is not recommended. 8.7 Renal Impairment Dedicated studies of the effect of renal impairment on leflunomide pharmacokinetics have not been conducted.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Based on animal data, human plasma concentrations of teriflunomide of less than 0.02 mg/L (0.02 mcg/mL) are expected to have minimal embryo-fetal risk [see Contraindications (4) , Warnings and Precautions (5.3), and Use in Specific Populations (8.1) ] . 5.2 Hepatotoxicity Severe liver injury, including fatal liver failure, has been reported in some patients treated with leflunomide.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to leflunomide during pregnancy.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Health care providers and patients are encouraged to report pregnancies by calling 1-877-311-8972 or visit http://www.pregnancystudies.org/participate-in-a-study/.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Risk Summary Leflunomide is contraindicated for use in pregnant women because of the potential for fetal harm.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Leflunomide may cause fetal harm when administered during pregnancy.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Advise females of the potential risk to the fetus.",
        "source": "US FDA label for leflunomide (Leflunomide), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      },
      {
        "text": "Advise females to notify their healthcare provider immediately if pregnancy occurs or is suspected during treatment [see Use in Specific Populations (8.1)] .",
        "source": "US FDA label for leflunomide (Leflunomide), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/leflunomide.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "pregnancy": {
      "level": "avoid",
      "line": "The label says not to use it. Read the quote below before deciding.",
      "set_by": "Set from the label's own words, not from a reading of them: 'contraindicated for use in pregnan'."
    }
  }
}