# Tadalafil ```text 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 ``` --- Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement. [Privacy policy](/privacy)