Maximum Dose of Daily Tadalafil
The maximum recommended dose of daily tadalafil is 5 mg once daily for erectile dysfunction and benign prostatic hyperplasia, though up to 40 mg once daily is FDA-approved specifically for pulmonary arterial hypertension. 1
FDA-Approved Daily Dosing by Indication
For Erectile Dysfunction
- Starting dose: 2.5 mg once daily 1
- Maximum dose: 5 mg once daily 1
- Taken at approximately the same time every day, without regard to timing of sexual activity 1
- The dose may be increased from 2.5 mg to 5 mg based on individual efficacy and tolerability 1
For Benign Prostatic Hyperplasia (BPH)
- Recommended dose: 5 mg once daily 1
- Taken at approximately the same time every day 1
- When initiating therapy for BPH with tadalafil and finasteride, the recommended dose remains 5 mg once daily for up to 26 weeks 1
For Combined ED and BPH
- Recommended dose: 5 mg once daily 1
- Taken at approximately the same time every day, without regard to timing of sexual activity 1
For Pulmonary Arterial Hypertension
- Maximum approved dose: 40 mg once daily 2, 3
- This substantially higher dose reflects the life-threatening nature of PAH versus the quality-of-life focus of ED treatment 3
Important Dosing Modifications
Renal Impairment
- Creatinine clearance 30-50 mL/min: Start at 2.5 mg once daily; may increase to 5 mg once daily based on response (for BPH/ED indications) 1
- Creatinine clearance <30 mL/min or hemodialysis: Daily tadalafil is not recommended for ED, BPH, or combined ED/BPH 1
Hepatic Impairment
- Mild to moderate hepatic impairment: Use with caution; daily dosing has not been extensively evaluated 1
- Severe hepatic impairment: Daily tadalafil is not recommended 1
Drug Interactions
- With potent CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole): Maximum dose is 2.5 mg once daily 1
Clinical Evidence Supporting Daily Dosing
Efficacy in General ED Population
- Tadalafil 5 mg once daily increased mean IIEF-EF domain scores by 8.6 to 21.9 versus 1.3 to 14.9 for placebo (p<0.01) 4, 5
- Successful intercourse attempts (SEP3) were 62% with 5 mg daily versus 33% for placebo (p<0.01) 5
- 39-40% of men who had incomplete response to as-needed PDE5 inhibitors achieved normal erectile function (IIEF-EF ≥26) with daily tadalafil versus 12.1% with placebo (p<0.001) 6
Efficacy in BPH/LUTS
- The 2021 AUA guidelines recommend 5 mg daily tadalafil as a treatment option for LUTS/BPH, particularly in men with comorbid ED 2
- The 2023 EAU guidelines support tadalafil 5 mg once daily for improving LUTS and erectile dysfunction 2
- Tadalafil significantly improves total IPSS, voiding and storage subscores, IPSS Quality of Life, and BPH Impact Index 7
Long-Term Safety
- Tadalafil 5 mg once daily was safe and well tolerated for up to 24 months 8
- Most common adverse events were headache (15.8%), dyspepsia (11.8%), nasopharyngitis (11.4%), and back pain (8.2%) 8
- Discontinuation rate due to adverse events was only 6.3% over 18-24 months 8
- Treatment-emergent adverse events with daily dosing were similar to as-needed treatment, with the most common events (dyspepsia, nasopharyngitis, headaches) reported in ≤4% of participants 5
Critical Clinical Caveats
Do Not Exceed 5 mg Daily for ED/BPH
- The FDA label explicitly states that 5 mg is the maximum for once-daily use in ED and BPH 1
- Higher doses (10-20 mg) are approved only for as-needed use, not daily administration 1
- The maximum dosing frequency for as-needed therapy is once per day in most patients 1
Combination Therapy Warnings
- Do not combine daily tadalafil 5 mg with alpha-blockers for LUTS/BPH treatment - it offers no advantages over either agent alone 2
- Patients on alpha-blockers for BPH should discontinue the alpha-blocker at least one day prior to starting daily tadalafil 1
- The combination increases risk of symptomatic hypotension without additional therapeutic benefit 2