See the DrugPatentWatch profile for tadalafil
Does Tadalafil Help with Enlarged Prostate Symptoms?
Yes, tadalafil (Cialis) treats symptoms of benign prostatic hyperplasia (BPH), or enlarged prostate. The FDA approved it in 2011 for this use, either alone or combined with finasteride (a 5-alpha reductase inhibitor). It relaxes smooth muscles in the prostate and bladder, improving urine flow, reducing urgency, and easing the need to urinate frequently or at night.[1][2]
How Does Tadalafil Work for BPH?
Tadalafil inhibits phosphodiesterase type 5 (PDE5), increasing cyclic GMP levels. This relaxes prostate and bladder neck muscles, countering BPH-related obstruction without shrinking the prostate gland itself—unlike finasteride, which does shrink it.[1][3]
What Dosage Is Used for BPH?
For BPH alone or with erectile dysfunction (ED), the standard dose is 5 mg once daily. Higher doses like 10-20 mg are for ED only, taken as needed. Patients often start with daily dosing for steady symptom relief.[1][2]
How Effective Is It Compared to Other BPH Treatments?
Clinical trials show tadalafil 5 mg daily improves International Prostate Symptom Score (IPSS) by 4-6 points over 12 weeks, similar to alpha-blockers like tamsulosin. It excels for men with both BPH and ED, outperforming placebo in urinary symptoms and quality of life. Combination with finasteride yields better long-term results than either alone.[3][4]
| Treatment | IPSS Improvement (12 weeks) | Also Treats ED? | Shrinks Prostate? |
|-----------|-----------------------------|-----------------|-------------------|
| Tadalafil 5 mg daily | 4-6 points | Yes | No |
| Tamsulosin (alpha-blocker) | 4-7 points | No | No |
| Finasteride | 2-4 points | No | Yes (over months) |
| Tadalafil + finasteride | 6-8 points | Yes | Yes |
What Side Effects Should Patients Watch For?
Common effects include headache (11-15%), indigestion (7-10%), back pain (3-8%), and nasal congestion (2-5%). Serious risks are rare but include priapism, sudden vision/hearing loss, or low blood pressure (especially with nitrates). It's generally well-tolerated long-term.[1][2]
Who Should Avoid Tadalafil for BPH?
Avoid if taking nitrates, riociguat, or strong CYP3A4 inhibitors (e.g., ketoconazole). Use caution with alpha-blockers due to hypotension risk, cardiovascular disease, or severe liver/kidney issues. Not for women or children.[1]
When Does It Start Working and How Long to Use?
Symptom relief begins within 1-2 weeks, peaking at 4-12 weeks. It's safe for continuous daily use; studies support up to 4 years without tolerance.[3][4]
Sources:
[1]: FDA Label for Cialis (tadalafil)
[2]: Mayo Clinic: Tadalafil for BPH
[3]: NEJM: Tadalafil for BPH Signs/Symptoms
[4]: PubMed: Long-term tadalafil use in BPH