Important Safety Information

• You take any nitrate medication, including nitroglycerin (tablets, sprays, patches, ointments), isosorbide mononitrate, or isosorbide dinitrate.
• You use recreational nitrites, commonly called "poppers" (amyl nitrite, butyl nitrite).
• You take a soluble guanylate cyclase stimulator such as riociguat (Adempas).
• You have had an allergic reaction to tadalafil, sildenafil, or another PDE5 inhibitor.
• Your healthcare provider has told you that sexual activity is not safe for you because of heart problems.

Combining a PDE5 inhibitor with nitrates or riociguat can cause a sudden, unsafe drop in blood pressure that may lead to fainting, stroke, heart attack, or death.

Your evaluation must include any history of:

• Heart disease, irregular heartbeat, heart attack, stroke, or heart failure
• High or low blood pressure, or blood pressure medications including alpha-blockers
• Liver or kidney disease, or dialysis
• Retinitis pigmentosa, other eye conditions, or a prior episode of NAION (sudden vision loss)
• Hearing loss or ringing in the ears
• Stomach ulcers or bleeding disorders
• Sickle cell anemia, multiple myeloma, leukemia, or a deformed penis, all of which raise the risk of priapism
• Any prior reaction to an ED medication

• Nitrates and riociguat: contraindicated (see above).
• Alpha-blockers (tamsulosin, doxazosin, etc.) and other antihypertensives: may cause additive low blood pressure.
• Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin, and HIV protease inhibitors including ritonavir: can raise drug levels significantly.
• CYP3A4 inducers such as rifampin: can reduce effectiveness.
• Other ED medications or supplements marketed for ED: do not combine. Some unregulated supplements secretly contain PDE5 inhibitors.
• Grapefruit juice: may increase drug levels.
• Alcohol: increases the risk of dizziness, low blood pressure, and fainting.

• Headache
• Flushing
• Indigestion, heartburn, or upset stomach
• Nasal congestion or runny nose
• Back pain or muscle aches
• Dizziness or lightheadedness
• Vision changes such as a blue tinge, blurred vision, or light sensitivity

Most side effects are mild and temporary. Contact your provider if they persist or become bothersome.

• An erection lasting more than 4 hours (priapism). Untreated priapism can cause permanent damage to the penis.
• Chest pain, pressure, or other symptoms of a heart attack or stroke during or after sexual activity.
• Sudden loss or decrease in vision in one or both eyes.
• Sudden loss or decrease in hearing, sometimes with ringing in the ears or dizziness.
• Fainting, severe dizziness, or signs of a serious allergic reaction such as rash, swelling of the face, lips, tongue, or throat, or difficulty breathing.

• Take exactly as prescribed. Never take more than one dose in a 24-hour period unless your provider explicitly instructs otherwise.
• Never share your medication. It was prescribed for your body and your medical history.
• Store it out of reach of children and pets, away from heat and moisture.
• Do not buy tadalafil or sildenafil from sources that do not require a prescription.
• Update your provider whenever you start a new medication or supplement.

Tadalafil and sildenafil are individually FDA-approved active ingredients. A compounded tadalafil/sildenafil rapid-dissolve tablet is prepared by a licensed compounding pharmacy and is not FDA-approved as a combination product. The FDA does not review compounded drugs for safety, effectiveness, or manufacturing quality. Compounded medications are prescribed when a provider determines a compounded formulation is clinically appropriate for a specific patient.

Report suspected side effects to your provider and to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. In an emergency, call 911.