{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "ribavirin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3) ]. 2.2 Ribavirin capsules/PegIntron Combination Therapy Adult Patients The recommended dose of ribavirin capsules when used in combination with PegIntron is 800 mg to 1,400 mg based on patient body weight in two divided doses (see Table 1).",
        "source": "This line points to a numbered table that this card does not show - read that table in the label before you dose. US FDA label for ribavirin (Ribavirin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "In patients with a history of stable cardiovascular disease, a permanent dose reduction is required if the hemoglobin decreases by 2 g/dL or more during any 4-week period.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "If the hemoglobin level remains below 12 g/dL after 4 weeks on a reduced dose, discontinue combination therapy.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness of ribavirin in combination with PegIntron has not been established in pediatric patients below the age of 3 years. For treatment with ribavirin/INTRON A, evidence of disease progression, such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load should be considered when deciding to treat a pediatric patient.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Ribavirin capsules are administered according to body weight. ( 2.1 , 2.2 , 2.3 ) Dose reduction or discontinuation is recommended in patients experiencing certain adverse reactions or renal dysfunction. ( 2.5 , 2.6 , 12.3 ) 2.1 General Dosing Information Do not open, crush or break ribavirin capsules. Ribavirin capsules should be taken with food [see Clinical Pharmacology (12.3) ].",
        "source": "US FDA label for ribavirin (Ribavirin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Juvenile Animal Toxicity Data In a study in which rat pups were dosed postnatally with ribavirin at doses of 10, 25, and 50 mg/kg/day, drug-related deaths occurred at 50 mg/kg (at rat pup plasma concentrations below human plasma concentrations at the human therapeutic dose) between study Days 13 and 48.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "Ribavirin capsules are contraindicated in patients with creatinine clearance less than 50 mL/min [see Contraindications (4) ] .",
        "source": "US FDA label for ribavirin (Ribavirin), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Ribavirin should not be used in patients with creatinine clearance less than 50 mL/min [see Contraindications (4) ] .",
        "source": "US FDA label for ribavirin (Ribavirin), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for ribavirin (Ribavirin), retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Ribavirin is contraindicated for use in pregnant women and in men whose female partners are pregnant [see Contraindications (4) ] .",
        "source": "US FDA label for ribavirin (Ribavirin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Based on animal data, ribavirin use in pregnancy may be associated with birth defects.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Data from the Ribavirin Pregnancy Registry are insufficient to identify a drug-associated risk of birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .",
        "source": "US FDA label for ribavirin (Ribavirin), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Ribavirin may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ].",
        "source": "US FDA label for ribavirin (Ribavirin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Pregnancy Testing Ribavirin therapy should not be started until a report of a negative pregnancy test has been obtained immediately prior to planned initiation of treatment.",
        "source": "US FDA label for ribavirin (Ribavirin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.json",
        "verbatim": true
      },
      {
        "text": "Patients should have periodic pregnancy tests during treatment and during the 9-month period after treatment has been stopped [see Warnings and Precautions (5.1) ].",
        "source": "US FDA label for ribavirin (Ribavirin), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/ribavirin.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'."
    }
  }
}