{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tiopronin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "The recommended initial dosage in adult patients is 800 mg/day.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "In clinical studies, the average dosage was about 1,000 mg/day.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Recommended Dosage Adults : The recommended initial dosage in adult patients is 800 mg/day.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Tiopronin delayed-release tablets are indicated in pediatric patients 9 years of age and older with severe homozygous cystinuria, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation who are not responsive to these measures alone. This indication is based on safety and efficacy data from a trial in patients 9 years to 68 years of age and clinical experience .",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. ( 2.1 ) The recommended initial dosage in pediatric patients 9 years of age and older is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients .",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "Pediatric patients receiving greater than 50 mg/kg tiopronin per day may be at greater risk [see Dosage and Administration ( 2.1 , 2.3 ), Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )].",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No kidney-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for tiopronin (TIOPRONIN), retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": false
      }
    ],
    "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 tiopronin (TIOPRONIN), retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available published case report data with tiopronin have not identified a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "Renal stones in pregnancy may result in adverse pregnancy outcomes (see Clinical Considerations).",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, there were no adverse developmental outcomes with oral administration of tiopronin to pregnant mice and rats during organogenesis at doses up to 2 times a 2 grams/day human dose (based on mg/m 2 ).",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: Breastfeeding is not recommended.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      },
      {
        "text": "Data Animal Data No findings of fetal malformations could be attributed to the drug in reproduction studies in mice and rats at doses up to 2 times the highest recommended human dose of 2 grams/day (based on mg/m 2 ). 8.2 Lactation Risk Summary There are no data on the presence of tiopronin in either human or animal milk or on the effects of the breastfed child.",
        "source": "US FDA label for tiopronin (TIOPRONIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tiopronin.json",
        "verbatim": true
      }
    ]
  }
}