Tadalafil 35 mg Daily Dosing is NOT Recommended
No, a patient weighing 200 lbs should not take 35 mg of tadalafil daily, as this exceeds the maximum FDA-approved dose for any indication and significantly increases the risk of adverse effects without proven additional benefit. 1
Maximum Approved Doses by Indication
The FDA-approved maximum doses for tadalafil are indication-specific and should not be exceeded 1:
- Erectile Dysfunction (ED): Maximum 20 mg as needed (not daily) OR 5 mg once daily 1
- Pulmonary Arterial Hypertension (PAH): Maximum 40 mg once daily 1
- Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia (LUTS/BPH): 5 mg once daily 2
Why 35 mg Daily is Problematic
For ED treatment specifically, 35 mg daily represents a seven-fold increase over the approved daily dose and exceeds even the as-needed maximum by 75%. 1 This dosing has no supporting evidence and poses unnecessary risks.
Key Safety Concerns at Supramaximal Doses
The most common adverse effects of tadalafil include 1, 3:
- Headache (15.8% at approved doses)
- Dyspepsia (11.8%)
- Back pain (8.2%)
- Myalgia
- Nasal congestion
- Flushing
- Dizziness
These side effects would be expected to occur with greater frequency and severity at 35 mg daily. 3
Evidence-Based Dosing Recommendations
For Erectile Dysfunction
Daily dosing: Tadalafil 5 mg once daily is effective and well-tolerated for long-term ED management, eliminating the need to time sexual activity. 4, 5 Studies demonstrate sustained efficacy over 2 years with this dose. 4
As-needed dosing: Start with 10 mg, which can be increased to 20 mg if needed for satisfactory intercourse, or reduced to 5 mg if persistent adverse effects occur. 3, 6 Patients with severe ED and organic comorbidities may benefit more from 20 mg compared to 10 mg. 6
For LUTS/BPH with Comorbid ED
The American Urological Association recommends 5 mg daily tadalafil as a treatment option for men with LUTS/BPH, particularly those with comorbid ED. 2 This dose provides dual benefits without requiring higher doses. 2
Critical Dosing Principle
The half-life of tadalafil is 17.5 hours, meaning daily dosing leads to drug accumulation. 7 Taking 35 mg daily would result in substantially higher steady-state plasma concentrations than intended by any approved regimen, dramatically increasing toxicity risk without evidence of improved efficacy.
Appropriate Clinical Approach
If the patient is not achieving adequate response with standard dosing 1, 4:
- Verify adherence to the prescribed regimen and proper timing relative to sexual activity
- Assess for inadequate sexual stimulation, as PDE5 inhibitors require normal sexual stimulus to be effective 7
- Evaluate for undertreated comorbidities (diabetes, hypertension, cardiovascular disease) that impair erectile function 5, 6
- Consider switching from daily 5 mg to as-needed 20 mg dosing, or vice versa, depending on current regimen 1, 3
- Reassess the diagnosis and consider alternative or combination therapies if maximum approved doses fail
Weight is not a factor in tadalafil dosing—the 200 lb body weight does not justify dose escalation beyond FDA-approved maximums. 1