{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "nitroglycerin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) intra-anally every 12 hours for up to 3 weeks.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "To obtain a 1.5 mg dose of nitroglycerin, the covered finger is laid alongside the 1-inch dosing line on the carton.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "Apply 1 inch of ointment (375 mg of ointment equivalent to 1.5 mg of nitroglycerin) intra-anally every 12 hours for up to 3 weeks ( 2 ).",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of nitroglycerin ointment, 0.4% in pediatric patients under 18 years of age have not been established.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.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 nitroglycerin (NITROGLYCERIN), retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.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 nitroglycerin (NITROGLYCERIN), retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category C Animal reproduction and teratogenicity studies have not been conducted with nitroglycerin ointment, 0.4%.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "Nitroglycerin was not teratogenic when administered by topical or dietary route.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "It is not known whether nitroglycerin is excreted in human milk.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin ointment, 0.4% is administered to a nursing woman.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      },
      {
        "text": "The latter finding probably reflects delayed development, thus indicating no clear evidence of a potential teratogenic effect of nitroglycerin. 8.3 Nursing Mothers It is not known whether nitroglycerin is excreted in human milk.",
        "source": "US FDA label for nitroglycerin (NITROGLYCERIN), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/nitroglycerin.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'caution should be exercised when nitroglycerin ointment, 0.4% is administered to a nursing'."
    }
  }
}