Tadalafil 20mg Daily Dosing Safety and Efficacy
Tadalafil should not be taken at the 20mg dose on a daily basis as this exceeds the FDA-approved dosing regimen for daily use, which is limited to 2.5-5mg daily.
Approved Dosing Regimens for Tadalafil
Tadalafil has two distinct dosing regimens that are FDA-approved:
As-needed dosing:
- 10-20mg taken prior to anticipated sexual activity
- Maximum recommended frequency: once per day
- Effective for up to 36 hours after dosing 1
Once-daily dosing:
- 2.5-5mg taken at approximately the same time every day
- For erectile dysfunction: Start with 2.5mg, may increase to 5mg based on efficacy and tolerability
- For BPH or combined ED/BPH: 5mg daily 1
Safety Concerns with 20mg Daily Dosing
Taking tadalafil 20mg daily would result in:
- Excessive drug accumulation due to tadalafil's long half-life (17.5 hours) 2
- Increased risk of adverse effects including:
- Headache
- Dyspepsia (indigestion)
- Back pain
- Myalgia (muscle pain)
- Flushing
- Nasal congestion 1
Evidence Supporting Approved Dosing
- Clinical trials specifically evaluated tadalafil at 2.5mg and 5mg for daily dosing, not 20mg 3
- Long-term safety studies for daily dosing were conducted using the 5mg dose, not higher doses 4
- The 20mg dose was only studied and approved for as-needed use 1
Erectile Dysfunction Treatment Options
For patients seeking daily treatment for ED:
First-line: Tadalafil 2.5-5mg daily, which has demonstrated:
- Significant improvement in erectile function
- Maintenance of efficacy for up to 2 years
- Good tolerability profile 4
- Elimination of the need to time medication with sexual activity
Alternative approach: As-needed tadalafil 10-20mg, which:
- Can be effective within 16-30 minutes of dosing 5
- Provides efficacy for up to 36 hours
- Is appropriate for patients who prefer not to take daily medication
Special Considerations
For patients who have not achieved normal erectile function with as-needed PDE5 inhibitors:
- Switching to daily tadalafil 5mg may help restore normal erectile function in approximately 40% of cases 6
Bottom Line
The 20mg dose of tadalafil is only approved for as-needed use, not daily administration. Patients requiring daily treatment should use the approved 2.5-5mg daily doses, which provide effective treatment with a better safety profile.