{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "timolol",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "One drop of Timolol Maleate Ophthalmic Solution 0.5% should be administered in the affected eye(s) once a day in the AM. One drop in the affected eye(s) once a day in the AM. ( 2 )",
        "source": "US FDA label for timolol (Timolol Maleate), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Safety and effectiveness in pediatric patients have not been established.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/timolol.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 timolol (Timolol Maleate), retrieved 2026-08-29",
        "cached_file": "labels/timolol.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 timolol (Timolol Maleate), retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic Effects Teratogenicity studies have been performed in animals.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      },
      {
        "text": "Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      },
      {
        "text": "Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Timolol has been detected in human milk following oral and ophthalmic drug administration.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      },
      {
        "text": "Because of the potential for serious adverse reactions from Timolol Maleate Ophthalmic Solution 0.5% in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/timolol.json",
        "verbatim": true
      },
      {
        "text": "Timolol Maleate Ophthalmic Solution 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 8.3 Nursing Mothers Timolol has been detected in human milk following oral and ophthalmic drug administration.",
        "source": "US FDA label for timolol (Timolol Maleate), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/timolol.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: 'should be used during pregnancy only if'."
    }
  }
}