Tadalafil — Important Safety Information

What is the FDA-approved use of tadalafil?

Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

Who should not use tadalafil?

Do not use tadalafil if:

• You are taking a class of medications called nitric oxide donors, including organic nitrates or organic nitrites in any form.
• You have a known allergy to tadalafil.
• You are taking a class of medications called guanylate cyclase (GC) stimulators, such as riociguat.

How should I take tadalafil?

Tadalafil can be taken with or without food. Limit alcohol to fewer than 5 drinks.

• As-needed use: Take about 30 minutes before anticipated sexual activity.
• Daily use: Take once daily at about the same time every day.

Do not take more than once in a 24-hour period or within 24 hours of any other ED medications or PDE-5 inhibitors.

What should I tell my EOS Health-affiliated provider?

Tell your provider all medications you take. Watch out for interactions with nitrates, alpha-blockers, antihypertensives, CYP3A4 inhibitors (ritonavir, ketoconazole, itraconazole, erythromycin), and alcohol >5 units.

Share your full medical history, especially: cardiovascular risk, chest pain requiring nitroglycerin, priapism predisposition, BPH on alpha-blockers, ventricular outflow obstruction, MI/stroke/arrhythmia history, low or high BP, unstable angina, NAION, bleeding disorders, kidney/liver disease, pulmonary hypertension, retinitis pigmentosa.

Most serious side effects

If experiencing a medical emergency, call 911.

• Cardiac risk of sexual activity — not for men for whom sexual activity is inadvisable.
• Prolonged erections: Seek emergency treatment for erection lasting >4 hours.
• Vision or hearing changes: Stop medication and seek care.
• Severely low blood pressure when combined with alpha-blockers, BP-lowering drugs, or CYP3A4 inhibitors.
• Kidney or liver impairment: Dose adjustment may be required.
• Combination with other PDE-5 inhibitors: Do not exceed once per 24 hours.
• STIs: Tadalafil does not protect against sexually transmitted diseases.

Most common side effects

• Headache, indigestion, back pain, muscle pain, nasal congestion, flushing, pain in limb.

You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

This information is not comprehensive. Please see the full Prescribing Information for complete safety information.