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Table of Contents

1. Tadalafil

Tadalafil

What Should You Know Before Taking Tadalafil

Disclaimer: The information provided on this page is not a substitute for professional medical advice, diagnosis, or treatment. If you have any questions or concerns about your health, please talk to a doctor.

Contraindications

Who should not take Tadalafil? Do not take Tadalafil if you:

• take medicines called nitrates (such as nitroglycerin)

• use street drugs called "poppers" such as amyl nitrate or amyl nitrite, and butyl nitrate

• take any medicines called guanylate cyclase stimulators such as riociguat (Adempas)

• are allergic to Tadalafil or any of the ingredients in Tadalafil. See the end of this section for a complete list of ingredients in Tadalafil.

What should I tell my healthcare provider before taking Tadalafil?

To make sure Tadalafil is safe for you, tell your healthcare provider if you have any of the following before you take Tadalafil?:

• Have or have had heart problems such as a heart attack,irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure

• Have had heart surgery within the last 6 months

• Have pulmonary hypertension

• Have had a stroke

• Have low blood pressure, or high blood pressure that is not controlled

• Have a deformed penis shape

• Have had an erection that lasted for more than 4 hours

• Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia

• Have retinitis pigmentosa, a rare genetic (runs in families) eye disease

• Have ever had severe vision loss, including an eye problem called NAION

• Have bleeding problems

• Have or have had stomach or intestinal ulcers

• Have liver problems

• Have kidney problems or are having kidney dialysis

• Have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tadalafil may affect the way other medicines work, and other medicines may affect the way Tadalafil works, causing side effects.

Drug Interactions

Tell your healthcare provider if you take any of the following because these drugs interact with Tadalafil:

• Medicines called nitrates

• Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)

• Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of Tadalafil with alpha-blockers can lead to a drop in blood pressure or to fainting

• Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)

• Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)

• Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin

• Other medicines that treat high blood pressure

• Other medicines or treatments for ED

• Adcirca® (tadalafil) is used to treat a rare disease called pulmonary arterial hypertension (PAH) and has the same active ingredient as Tadalafil. Tadalafil should not be used with Adcirca® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Revatio® [sildenafil citrate])

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Tadalafil Side Effects

What are the possible side effects of Tadalafil?

Tadalafil can cause serious side effects. Rarely reported side effects include:

• an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.

• sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking Tadalafil and call your healthcare provider right away if you have sudden vision loss in one or both eyes.

• sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking Tadalafil and contact a doctor right away.

The most common side effects of Tadalafil are:

• headache

• flushing

• upset stomach

• abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision

• stuffy or runny nose

• back pain

• muscle pain

• nausea

• dizziness

• Rash

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Tadalafil. Most, but not all, of these men had heart problems before taking Tadalafil. It is not known if Tadalafil caused these problems.

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of Tadalafil. For more information, ask your healthcare provider or pharmacist.

Talk to your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Happens if I Overdose?

Taking more than the recommended amount of Tadalafil greatly increases your risk of side effects, including severe ones that can be dangerous, such as severe low blood pressure or an erection that won’t go away even after 4 or more hours (priapism). Never take more than the amount prescribed to you by your doctor. If you have any severe side effects after taking more than the recommended amount, or even after taking the amount of medicine prescribed to you, seek out emergency medical attention immediately.