Is tadalafil (Cialis) safe for patients with a history of prostate bleeding or at increased risk of bleeding, particularly those with Benign Prostatic Hyperplasia (BPH)?

Tadalafil and Prostate Bleeding Risk

Tadalafil is safe for patients with benign prostatic hyperplasia (BPH), including those with a history of prostate bleeding, as there is no evidence linking PDE5 inhibitors to increased bleeding risk in the prostate or lower urinary tract. 1, 2

Safety Profile in BPH Patients

• Tadalafil 5 mg once daily is FDA-approved and recommended as first-line therapy for men with both BPH and erectile dysfunction, with no contraindications related to prostate bleeding. 3, 2

• The most common adverse effects of tadalafil in BPH patients are headache (3.7%), back pain (3.1%), dyspepsia, nasal congestion, flushing, and dizziness—none of which involve bleeding complications. 2, 4

• In clinical trials enrolling over 6,400 men with BPH treated with tadalafil, no increased risk of prostate bleeding or hematuria was reported compared to placebo. 1, 2

Actual Bleeding Contraindications

The absolute contraindications to tadalafil are related to cardiovascular risks, not bleeding: 1, 5

• Concurrent use of nitrates or guanylate cyclase stimulators (riociguat)
• Recent stroke or myocardial infarction (within 24 hours for most PDE5 inhibitors, 48 hours for tadalafil specifically when considering nitrate use)
• Uncontrolled hypertension or hypotension
• Severe hepatic impairment

Distinguishing Bleeding Risk from Other Medications

If your patient is on anticoagulants or antiplatelets, the bleeding risk comes from those medications, not from tadalafil: 1

• Anticoagulants (warfarin, DOACs) increase risk of gastrointestinal and intracranial bleeding, particularly in patients ≥75 years. 1
• Antiplatelets (aspirin, clopidogrel) increase bleeding risk, especially when combined with anticoagulants, NSAIDs, SSRIs, or SNRIs. 1
• Tadalafil does not interact with anticoagulants or antiplatelets to increase bleeding risk. 1, 2

Clinical Recommendations for BPH Patients

For men with BPH and erectile dysfunction, prescribe tadalafil 5 mg once daily as monotherapy, which effectively treats both conditions simultaneously without sexual side effects seen with alpha-blockers or 5-alpha reductase inhibitors. 3, 2

• Tadalafil significantly improves International Prostate Symptom Score (IPSS) by -5.6 points at 12 weeks compared to -3.6 with placebo (p=0.004), with symptom improvement apparent as early as 1 week. 2, 4

• If LUTS control is inadequate after 4-12 weeks of tadalafil monotherapy, add an alpha-blocker (preferably tamsulosin to minimize orthostatic hypotension), though this combination offers no additional LUTS benefit over either agent alone. 3

Special Consideration: 5-Alpha Reductase Inhibitors

5-alpha reductase inhibitors (finasteride, dutasteride) may reduce intraoperative bleeding during transurethral resection of the prostate (TURP), but this is unrelated to tadalafil use. 1

• Reserve 5-ARIs for men with documented prostate enlargement (volume >30cc, PSA >1.5 ng/mL, or palpable enlargement on digital rectal exam). 1, 3
• 5-ARIs reduce prostate size by 15-25% over 6 months and decrease perioperative bleeding risk during surgical intervention. 1

Common Pitfall to Avoid

Do not confuse the bleeding risk associated with anticoagulants/antiplatelets with tadalafil use—tadalafil does not cause or exacerbate bleeding in the prostate or urinary tract. 1, 2, 4