Cialis Safety Information

Important Safety Information for Cialis® & Generic of Cialis (Tadalafil)

** FDA-Approved Use**

Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED).

Who Should Not Use Tadalafil

Do not use tadalafil if any of the following apply:

• You are taking nitrate medications, nitric oxide donors, or organic nitrites in any form. Combining these with tadalafil can cause a dangerous drop in blood pressure.
• You are using guanylate cyclase (GC) stimulators, such as riociguat.
• You are allergic to tadalafil or any of its components.

How to Take Tadalafil

Tadalafil may be taken with or without food. Limit alcohol consumption to no more than five standard drinks.

• As-needed use: Take about 30 minutes before anticipated sexual activity.

• Daily use: Take once a day at roughly the same time, regardless of sexual activity.

  Do not take tadalafil more than once in a 24-hour period or in combination with other PDE5 inhibitors or ED medications. Always take this medication exactly as prescribed. If symptoms do not improve or you experience side effects, contact your healthcare provider.

Before Using Tadalafil - Tell Your Healthcare Provider

Inform your provider about all medications, supplements, and health conditions before starting tadalafil. This includes prescription and non-prescription drugs, vitamins, and herbal supplements.

Important interactions include:

• Nitrates, alpha-blockers, and blood pressure medications: May cause a sudden drop in blood pressure when combined with tadalafil.
• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Can increase tadalafil concentration, potentially leading to low blood pressure or prolonged erection.
• Alcohol: Consuming large amounts (>5 drinks) may increase the risk of dizziness or fainting.

Provide your full medical history, especially if you have or have ever had:

• Heart disease, chest pain, or a history of heart attack, stroke, or irregular heartbeat
• Low or high blood pressure
• Kidney or liver disease
• Benign prostatic hyperplasia (BPH) treated with alpha-blockers
• Bleeding disorders or stomach ulcers
• Eye conditions such as non-arteritic anterior ischemic optic neuropathy (NAION) or “crowded” optic disc
• Pulmonary hypertension
• Priapism (painful erections lasting more than 4 hours)
• Retinitis pigmentosa or severe vision impairment
• Providing inaccurate or incomplete medical information may increase health risks and, in rare cases, result in serious harm.

Serious Side Effects - When to Seek Medical Help

Call 911 or seek emergency care if you experience:

• Chest pain, dizziness, or fainting during sexual activity
• An erection lasting more than 4 hours (priapism)
• Sudden vision loss in one or both eyes
• Sudden hearing loss or ringing in the ears

If you are taking medications for blood pressure or alpha-blockers, tadalafil may enhance their effects, leading to low blood pressure. Report symptoms like dizziness, lightheadedness, or fainting to your provider.

Patients with kidney or liver impairment should discuss dosage adjustments before starting tadalafil. Avoid consuming excessive alcohol while using tadalafil.

Do not combine tadalafil with other PDE5 inhibitors or ED treatments.

Tadalafil does not prevent sexually transmitted infections - always use safe sex practices.

** Most Common Side Effects**

The most commonly reported side effects include:

• Headache
• Indigestion
• Back pain
• Muscle aches
• Nasal congestion
• Flushing (warmth or redness)
• Pain in arms or legs

These side effects are typically mild and temporary. If symptoms persist or worsen, contact your healthcare provider.

Reporting Side Effects

You are encouraged to report negative side effects of prescription medications to the U.S. Food and Drug Administration (FDA).

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Additional Information

This summary does not contain all available safety information. Please review the full Prescribing Information or consult your licensed healthcare provider for complete details.