Does tadalafil raise PSA levels? This is a common concern for men taking this medication for erectile dysfunction or benign prostatic hyperplasia (BPH) who also require prostate health monitoring. Tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, works by improving blood flow and relaxing smooth muscle. Unlike some prostate medications, clinical evidence consistently shows that tadalafil does not significantly affect prostate-specific antigen (PSA) levels. This means PSA testing remains a valid monitoring tool for men using tadalafil. Understanding this relationship is important for informed decision-making about both treatment and prostate health screening.

What Is Tadalafil and How Does It Work?

Tadalafil is a prescription medication primarily used to treat erectile dysfunction (ED) and the urinary symptoms associated with benign prostatic hyperplasia (BPH). It belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which also includes sildenafil and vardenafil.

The mechanism of action involves inhibiting the PDE5 enzyme, which is found in smooth muscle cells lining blood vessels. When PDE5 is blocked, levels of cyclic guanosine monophosphate (cGMP) increase, leading to smooth muscle relaxation and improved blood flow. In the context of erectile dysfunction, this enhanced blood flow to the penis facilitates achieving and maintaining an erection in response to sexual stimulation. For BPH, tadalafil relaxes smooth muscle in the prostate and bladder, improving urinary flow and reducing bothersome lower urinary tract symptoms.

Tadalafil is available in different formulations and doses. Cialis is the branded version, whilst generic tadalafil is widely available in the UK. For erectile dysfunction, it can be taken as needed (typically 10 mg or 20 mg) or as a daily low-dose treatment (2.5 mg or 5 mg). For BPH, the usual dose is 5 mg once daily. The medication has a notably long half-life of approximately 17.5 hours, allowing for extended duration of action.

Tadalafil is generally well-tolerated, though common side effects include headache, indigestion, back pain, muscle aches, flushing, and nasal congestion. These effects are usually mild and transient. The medication is contraindicated in patients taking nitrates (including recreational 'poppers') or guanylate cyclase stimulators such as riociguat due to the risk of severe hypotension. Caution is needed when taking alpha-blockers (risk of orthostatic hypotension) and with potent CYP3A4 inhibitors. For BPH treatment, baseline prostate assessment including digital rectal examination (DRE) and PSA testing is recommended before starting treatment.

If you experience an erection lasting more than 4 hours, sudden vision or hearing changes, or chest pain, seek immediate medical attention. Suspected side effects can be reported via the MHRA Yellow Card scheme (yellowcard.mhra.gov.uk).

Understanding PSA Levels and Prostate Health

Prostate-specific antigen (PSA) is a protein produced by cells in the prostate gland, both normal and cancerous. It is released into the bloodstream and can be measured through a simple blood test. PSA testing is commonly used as part of prostate health monitoring, particularly in men over 50 or those with risk factors for prostate cancer.

Elevated PSA levels can indicate various prostate conditions, not exclusively cancer. Benign prostatic hyperplasia (BPH), prostatitis (inflammation of the prostate), urinary tract infections, and even recent ejaculation or vigorous exercise can temporarily raise PSA levels. Prostate cancer is another potential cause of elevated PSA. It's important to note that early prostate cancer is often asymptomatic.

In the UK, there is no national PSA screening programme. Instead, the NHS Prostate Cancer Risk Management Programme provides information to help men make an informed choice about PSA testing. Normal PSA levels vary by age, with higher thresholds for older men. Your laboratory will provide age-specific reference ranges, and results are typically reported in µg/L (equivalent to ng/mL).

It is important to understand that PSA is not a definitive diagnostic tool for prostate cancer. Elevated levels warrant further investigation, which may include repeat testing, digital rectal examination (DRE), multiparametric MRI scanning, or prostate biopsy. Conversely, some men with prostate cancer may have PSA levels within the normal range, particularly in the early stages of disease.

Factors affecting PSA interpretation include prostate size, recent instrumentation (delay testing for at least 6 weeks after catheterisation or biopsy), active urinary tract infections or prostatitis, medications (such as 5-alpha reductase inhibitors), and individual variation. To improve test accuracy, avoid ejaculation and vigorous exercise or cycling for 48 hours before the test, and ideally have blood taken before any digital rectal examination.

Clinical Evidence on Tadalafil and PSA Levels

The question of whether tadalafil raises PSA levels has been examined in several clinical studies, and the evidence consistently suggests that tadalafil does not significantly affect PSA levels. This is an important consideration for men taking the medication who may also be undergoing prostate health monitoring.

Studies published in the Journal of Urology have examined men with BPH taking tadalafil 5 mg daily over extended periods, including 12-month follow-up data. These research findings show no clinically significant changes in PSA levels compared to placebo. Similar results have been reported in multiple randomised controlled trials evaluating tadalafil for both erectile dysfunction and BPH symptoms. The UK regulatory documents, including the Summary of Product Characteristics (SmPC) and European Public Assessment Report (EPAR), confirm these findings.

Unlike 5-alpha reductase inhibitors (such as finasteride and dutasteride), which are known to reduce PSA levels by approximately 50% after six months of treatment, PDE5 inhibitors like tadalafil work through an entirely different mechanism. They do not affect androgen metabolism or prostate tissue growth, which explains why they do not alter PSA production or secretion.

This distinction is clinically important because it means that PSA testing remains a valid monitoring tool for men taking tadalafil. Healthcare professionals do not need to adjust PSA reference ranges or interpretation when patients are using this medication. However, it is always advisable to inform your GP about all medications you are taking, including tadalafil, when undergoing PSA testing.

Current evidence shows no clinically meaningful impact of tadalafil on PSA levels. If a man taking tadalafil experiences a rise in PSA, this should be investigated according to standard clinical protocols, as the elevation is unlikely to be medication-related and may indicate an underlying prostate condition requiring attention. For men using tadalafil for BPH, baseline prostate assessment (including PSA and DRE) and periodic review are still recommended as part of standard care.

When to Discuss PSA Testing with Your GP

Men considering PSA testing should have an informed discussion with their GP to understand the potential benefits, limitations, and implications of the test. This is particularly important for men over 50, those with a family history of prostate cancer, or Black men, including those of African or Caribbean heritage, who have a higher risk of developing the disease.

You should consider discussing PSA testing if you experience any of the following symptoms:

• Difficulty starting or maintaining urination

• Weak or interrupted urinary stream

• Increased frequency of urination, especially at night (nocturia)

• Urgent need to urinate

• Blood in urine or semen

• Pain or discomfort in the pelvic area

• Unexplained lower back or bone pain

It's important to note that early prostate cancer is frequently asymptomatic, so absence of symptoms does not rule out the condition.

If you are already taking tadalafil for erectile dysfunction or BPH symptoms, you can be reassured that the medication will not interfere with PSA test accuracy. However, do inform your GP about your tadalafil use and any other medications, as some drugs (particularly 5-alpha reductase inhibitors) do affect PSA levels and require adjusted interpretation.

For men with an elevated PSA result, your GP will typically recommend repeat testing after a few weeks, as levels can fluctuate. You should avoid ejaculation, vigorous exercise, and cycling for 48 hours before the test, as these activities can temporarily raise PSA. Defer testing for at least 6 weeks after a urinary tract infection, prostatitis, or any urinary instrumentation or biopsy. If PSA remains above the age-specific reference range or if digital rectal examination is abnormal, your GP should consider referral via the suspected cancer (2-week-wait) pathway in line with NICE guidance.

Seek urgent medical advice if you experience acute urinary retention (inability to pass urine), severe pain, or visible blood in your urine. These symptoms require prompt assessment and may indicate complications requiring immediate intervention. Regular monitoring and open communication with your healthcare team are essential for maintaining optimal prostate health whilst safely using medications like tadalafil.

Frequently Asked Questions