{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "terbinafine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.1 ) • Fingernail onychomycosis: One 250 mg tablet, once daily for 6 weeks.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) • Toenail onychomycosis: One 250 mg tablet, once daily for 12 weeks.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Assessment Prior to Initiation Before administering terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ]. 2.2 Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and efficacy of terbinafine tablets have not been established in pediatric patients with onychomycosis.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of terbinafine tablets has not been adequately studied.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "• Prior to administering, evaluate patients for evidence of chronic or active liver disease.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) 2.1 Assessment Prior to Initiation Before administering terbinafine tablets, evaluate patients for evidence of chronic or active liver disease [see Contraindications (4) and Warnings and Precautions (5.1) ]. 2.2 Dosage Fingernail onychomycosis: One 250 mg tablet once daily for 6 weeks.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment In patients with renal impairment (creatinine clearance less than or equal to 50 mL/min), the use of terbinafine tablets has not been adequately studied.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Pregnancy Category B There are no adequate and well-controlled studies in pregnant women.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "Because animal reproduction studies are not always predictive of human response, and because treatment of onychomycosis can be postponed until after pregnancy is completed, it is recommended that terbinafine tablets not be initiated during pregnancy.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "Oral reproduction studies have been performed in rabbits and rats at doses up to 300 mg/kg/day [12x to 23x the maximum recommended human dose (MRHD), in rabbits and rats, respectively, based on body surface area (BSA) comparisons] and have revealed no evidence of impaired fertility or harm to the fetus due to terbinafine.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "After oral administration, terbinafine is present in breast milk of nursing mothers.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "The ratio of terbinafine in milk to plasma is 7:1.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      },
      {
        "text": "Treatment with terbinafine tablets is not recommended in women who are nursing.",
        "source": "US FDA label for terbinafine (Terbinafine), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/terbinafine.json",
        "verbatim": true
      }
    ]
  }
}