Active Ingredients: Tadalafil

Important Safety Information for Tadalafil

Contraindications:

• Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

• Some medicines can cause unwanted or dangerous effects when used with tadalafil. Tell your doctor about all your current medicines, especially riociguat (Adempas). Do not take tadalafil with riociguat.
• Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Before taking this medication:

You should not use tadalafil if you are allergic to it, or:

• If you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).
• If you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

To make sure tadalafil is safe for you, tell your doctor if you have ever had:

• Heart problems (chest pain, a heart rhythm disorder, heart attack)
• Pulmonary hypertension
• High or low blood pressure
• Previous stroke
• Blood circulation problems
• Retinitis pigmentosa (an inherited condition of the eye)
• Severe vision problems (including NAION)
• Blindness in one or both eyes
• Bleeding problems
• A stomach ulcer
• Pulmonary veno-occlusive disease (PVOD)
• Liver or kidney disease or require dialysis
• A blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia
• A physical deformity of the penis (such as Peyronie's disease)
• If you have been told you should not have sexual intercourse for health reasons
• If you have ever had an erection lasting 4 hours or longer

Drug Interactions:

• Nitrates: Nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking a nitrate medicine with tadalafil can cause a dangerous decrease in blood pressure.
• Guanylate cyclase stimulators: Adempas® (riociguat)
• Alpha-blockers: Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin)
• HIV protease inhibitors: ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
• Oral antifungal medicines: ketoconazole (Nizoral®) and itraconazole (Sporanox®)
• Antibiotics: clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
• Other medicines that treat high blood pressure
• Other medicines or treatments for ED
• Cialis and generic Cialis also contain tadalafil, tadalafil is also found in a drug called Adcirca used for pulmonary arterial hypertension (PAH). Do not use tadalafil with Cialis, Adcirca, or with any other PDE5 inhibitor or erectile dysfunction treatment (sildenafil).

Side Effects:

Get emergency medical help if you have signs of an allergic reaction to tadalafil:

• Hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Stop taking tadalafil and get emergency medical help if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating
• vision changes or sudden vision loss
• erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis)
• ringing in your ears, or sudden hearing loss
• irregular heartbeat
• swelling in your hands, ankles, or feet
• shortness of breath
• seizure (convulsions)
• a light-headed feeling, like you might pass out

Common tadalafil side effects may include:

• flushing (warmth, redness, or tingly feeling)
• headache, dizziness
• heartburn, nausea, or upset stomach
• abnormal vision (blurred vision, changes in color vision, vision with a blue tinge)
• runny or stuffy nose, nosebleeds
• Rash
• Nausea
• muscle pain, back pain

Heart attack, irregular heartbeat, stroke, and death have occurred rarely in men taking Cialis. The majority of these men had severe cardiac problems before taking Cialis. It is not known if Cialis caused these problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Additional Resources

The following links provide further information on the potential risks and benefits of this medication:

• Official Tadalafil PDR
• FDA Tadalafil Prescribing Information

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