Terbinafine

DRUG INFORMATION

  ADULT
    - ( 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
    - ( 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
    - ( 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

  CHILD
    - 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

  RENAL IMPAIRMENT
    - 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

  HEPATIC IMPAIRMENT
    - • 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
    - ( 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - 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