{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "primaquine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Primaquine phosphate Tablets should be administered concurrently to eradicate the exoerythrocytic parasites in adults at a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      },
      {
        "text": "Primaquine phosphate Tablets are recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established. Primaquine phosphate Tablets are contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown (see CONTRAINDICATIONS and WARNINGS, Nursing Mothers ).",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.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 primaquine (Primaquine Phosphate), retrieved 2026-08-29",
        "cached_file": "labels/primaquine.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 primaquine (Primaquine Phosphate), retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Safe usage of Primaquine phosphate Tablets in pregnancy has not been established.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      },
      {
        "text": "Primaquine is contraindicated in pregnant women.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      },
      {
        "text": "The use of Primaquine phosphate Tablets during pregnancy may cause hemolytic anemia in a G6PD-deficient fetus.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "A breastfed infant with G6PD deficiency is at risk for hemolytic anemia from exposure to primaquine.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      },
      {
        "text": "Infant G6PD status should be checked before breastfeeding begins.",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.json",
        "verbatim": true
      },
      {
        "text": "Primaquine phosphate Tablets are contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown (see CONTRAINDICATIONS ).",
        "source": "US FDA label for primaquine (Primaquine Phosphate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/primaquine.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 in pregnan'."
    },
    "lactation": {
      "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 in breast'."
    }
  }
}