Tadalafil

DRUG INFORMATION

  ADULT
    - Tadalafil tablets for use as needed: ED: Starting dose: 10 mg as needed prior to
      sexual activity.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - Tadalafil tablets for once daily use: ED: 2.5 mg taken once daily, without regard
      to timing of sexual activity.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - BPH: 5 mg, taken at approximately the same time every day ( 2.3 ) ED and BPH: 5
      mg, taken at approximately the same time every day ( 2.3 , 2.4 ) Tadalafil tablets
      may be taken without regard to food ( 2.5 ). 2.1 Tadalafil Tablets for Use as
      Needed for Erectile Dysfunction The recommended starting dose of tadalafil tablets
      for use as needed in most patients is 10 mg, taken prior to anticipated sexual
      activity.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - Do not split Tadalafil tablets; entire dose should be taken. Tadalafil tablets for
      use as needed: ED: Starting dose: 10 mg as needed prior to sexual activity.
      Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves
      erectile function compared to placebo up to 36 hours post dose. Not to be taken
      more than once per day ( 2.1 ).
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to
      14 years of age) with Duchenne muscular dystrophy, who received tadalafil 0.3
      mg/kg, tadalafil 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate
      any benefit of treatment with tadalafil on a range of assessments of muscle
      strength and performance.
      Source: US FDA label for tadalafil (Tadalafil), section 'pediatric use', retrieved
      2026-08-29
    - Juvenile Animal Study No adverse effects were observed in a study in which
      tadalafil was administered orally at doses of 60 mg/kg/day, 200 mg/kg/day, and
      1000 mg/kg/day to juvenile rats on postnatal days 14 to 90.
      Source: US FDA label for tadalafil (Tadalafil), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - When therapy for BPH is initiated with tadalafil and finasteride, the recommended
      dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the
      same time every day for up to 26 weeks.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5
      mg not more than once in every 72 hours [see Warnings and Precautions ( 5.7 ) and
      Use in Specific Populations ( 8.7 )] .
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - Tadalafil tablets for Once Daily Use Erectile Dysfunction Creatinine clearance
      less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is
      not recommended [see Warnings and Precautions ( 5.7 ) and Use in Specific
      Populations ( 8.7 )] .
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic Impairment Tadalafil tablets for Use as Needed Mild or moderate (Child
      Pugh Class A or B): The dose should not exceed 10 mg once per day.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - The use of tadalafil tablets once per day have not been extensively evaluated in
      patients with hepatic impairment and therefore, caution is advised.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29
    - Tadalafil tablets for Once Daily Use Mild or moderate (Child Pugh Class A or B):
      Tadalafil tablets for once daily use has not been extensively evaluated in
      patients with hepatic impairment.
      Source: US FDA label for tadalafil (Tadalafil), section 'dosage and
      administration', retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Tadalafil is not indicated for use in females.
      Source: US FDA label for tadalafil (Tadalafil), section 'pregnancy', retrieved
      2026-08-29
    - There are no data with the use of tadalafil in pregnant women to inform any drug-
      associated risks for adverse developmental outcomes.
      Source: US FDA label for tadalafil (Tadalafil), section 'pregnancy', retrieved
      2026-08-29
    - In animal reproduction studies, no adverse developmental effects were observed
      with oral administration of tadalafil to pregnant rats or mice during
      organogenesis at exposures up to 11 times the maximum recommended human dose
      (MRHD) of 20 mg/day (see Data).
      Source: US FDA label for tadalafil (Tadalafil), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Infertility Based on the data from 3 studies in adult males, tadalafil decreased
      sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of
      20 mg tadalafil for 9 months.
      Source: US FDA label for tadalafil (Tadalafil), section 'nursing mothers',
      retrieved 2026-08-29
    - This effect was not seen in the study of 20 mg tadalafil taken for 6 months.
      Source: US FDA label for tadalafil (Tadalafil), section 'nursing mothers',
      retrieved 2026-08-29
    - There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of
      testosterone, luteinizing hormone or follicle stimulating hormone.
      Source: US FDA label for tadalafil (Tadalafil), section 'nursing mothers',
      retrieved 2026-08-29