Does tadalafil (Cialis) cause hypotension (low blood pressure)?

From the Guidelines

Tadalafil (Cialis) can cause hypotension, particularly when taken with certain medications like nitrates, due to its mechanism of relaxing blood vessels throughout the body. This is a critical consideration in patients with chronic coronary disease, as outlined in the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease 1. The guideline emphasizes that phosphodiesterase type 5 inhibitors, such as tadalafil, should not be used concomitantly with nitrate medications because of the potential for severe hypotension.

Key points to consider regarding the use of tadalafil and its potential to lower blood pressure include:

• The half-life of tadalafil is 17.5 hours, which is significantly longer than other phosphodiesterase type 5 inhibitors like sildenafil and vardenafil, implying a longer duration of action and potentially a longer risk period for hypotension 1.
• Patients on tadalafil should avoid taking nitroglycerine for at least 48 hours due to the risk of severe hypotension, highlighting the need for careful management and patient education 1.
• The decision to use tadalafil in patients on long-acting nitrate therapy should be guided by the need for continued nitrate therapy versus other alternative options, underscoring the importance of individualized care plans 1.

In clinical practice, it is essential to weigh the benefits of tadalafil for erectile dysfunction against the potential risks, particularly in patients with pre-existing cardiovascular conditions or those taking multiple medications that could interact with tadalafil. Monitoring for symptoms of hypotension and adjusting the treatment plan as necessary is crucial to minimize adverse effects while maximizing the quality of life for patients.

From the FDA Drug Label

As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations Effects on Blood Pressure When Administered with Antihypertensives A study was conducted to assess the interaction of amlodipine (5 mg daily) and tadalafil 10 mg. There was no effect of tadalafil on amlodipine blood levels and no effect of amlodipine on tadalafil blood levels The mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg in subjects taking amlodipine was 3/2 mm Hg, compared to placebo. In a similar study using tadalafil 20 mg, there were no clinically significant differences between tadalafil and placebo in subjects taking amlodipine Angiotensin II receptor blockers (with and without other antihypertensives) — A study was conducted to assess the interaction of angiotensin II receptor blockers and tadalafil 20 mg. Subjects in the study were taking any marketed angiotensin II receptor blocker, either alone, as a component of a combination product, or as part of a multiple antihypertensive regimen Following dosing, ambulatory measurements of blood pressure revealed differences between tadalafil and placebo of 8/4 mm Hg in systolic/diastolic blood pressure.

Tadalafil can lower blood pressure. The decrease in blood pressure is usually mild and transient. In healthy subjects, the mean maximal decrease in supine blood pressure was 1.6/0.8 mm Hg.

• When administered with antihypertensives, such as amlodipine, the mean reduction in supine systolic/diastolic blood pressure due to tadalafil 10 mg was 3/2 mm Hg, compared to placebo.
• Tadalafil can cause orthostatic hypotension, especially when combined with alcohol.
• Patients with certain medical conditions, such as heart disease, should use tadalafil with caution and under medical supervision 2, 2.

From the Research

Tadalafil and Blood Pressure

• Tadalafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction, and its effects on blood pressure have been studied in various trials 3, 4, 5, 6.
• In healthy volunteers, tadalafil has been shown to have minimal blood pressure-lowering effects 3.
• In patients taking antihypertensive medications, tadalafil may cause a reduction in blood pressure, but this is generally mild and not likely to be of clinical concern 4.
• However, combining tadalafil with nitric oxide donors can lead to life-threatening hypotension and is contraindicated 3, 6.
• The use of tadalafil with alpha-blocking agents, such as doxazosin, may require close blood pressure monitoring and should only be considered in hemodynamically stable patients 3.

Cardiovascular Safety

• Tadalafil has been shown to be safe in patients with cardiovascular diseases, including those with coronary artery disease (CAD) 6.
• The incidence of cardiovascular events, such as myocardial infarction and presumed thrombotic strokes, is low in tadalafil-treated patients and comparable to that observed in the age-standardized male population 6.
• However, as with any medication, patients with erectile dysfunction should undergo a complete diagnostic workup and potentially optimized cardiovascular treatment before being prescribed tadalafil 3.

Comparison to Other Medications

• Sildenafil, another phosphodiesterase 5 inhibitor, has also been shown to have blood pressure-lowering effects, particularly when combined with nitric oxide donors 7.
• However, the cardiovascular safety profile of tadalafil is similar to that of sildenafil, and both medications are contraindicated in patients receiving nitrate therapy due to the potential for significant hypotensive effects 7, 6.