What Is The Most Important Information I Should Know About CIALIS® (tadalafil) and generic CIALIS®? 

CIALIS® and generic CIALIS® can cause serious side effects. Serious, but rare, side effects include:

• An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections. 

• Changes in vision. Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green. 

• Sudden decrease or loss of vision. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS® and generic CIALIS®) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS® and generic CIALIS®, and call a healthcare provider right away. 

• Sudden loss or decrease in hearing. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS® and generic CIALIS®. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS® and generic CIALIS® and contact a healthcare provider right away. 

• CIALIS® and generic CIALIS® can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. You could get dizzy, faint, or have a heart attack or stroke. 

• Never take CIALIS® or generic CIALIS® with any nitrate or guanylate cyclase stimulator medicines. Do not take CIALIS® or generic CIALIS® if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. 

• Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. 

• Do not take CIALIS® or generic CIALIS® if you take medicines called guanylate cyclase stimulators which include: Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension (pulmonary hypertension due to chronic blood clots in the lungs). Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat. 

• Tell all of your healthcare providers that you take CIALIS® or generic CIALIS®. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took CIALIS® or generic CIALIS®. After taking a single tablet, some of the active ingredient of CIALIS® or generic CIALIS® remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications. 

• Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. 

CIALIS® and generic CIALIS® for the Treatment of erectile dysfunction (ED): 

• ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him.

• CIALIS® and generic CIALIS® help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Some form of sexual stimulation is needed for an erection to happen with CIALIS® or generic CIALIS®. 

• CIALIS® and generic CIALIS® do not: 

• Cure ED 

• Increase a man’s sexual desire 

• Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases. 

• Serve as a male form of birth control 

• Do not use CIALIS® or generic CIALIS® with other ED medications.

• CIALIS® and generic CIALIS® are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy. 

• CIALIS® and generic CIALIS® are not for women or children. 

• CIALIS® and generic CIALIS® must be used only under a healthcare provider’s care. 

• Take CIALIS® or generic CIALIS® exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you. Do not change your dose or the way you take CIALIS® or generic CIALIS® without talking to your healthcare provider.

Who Should Not Take CIALIS® or generic CIALIS®? 

Do not take CIALIS® or generic CIALIS® if you:

• Have severe liver disease. Tell your doctor if you have mild to moderate liver disease as you may need dosage reductions.

• Have severe kidney disease. Tell your doctor if you have mild to moderate kidney disease as you may need dosage reductions

• Take any medicines called “nitrates” 

• Use recreational drugs called “poppers” like amyl nitrite and butyl nitrite 

• Take any medicines called guanylate cyclase stimulators, such as riociguat 

• Are allergic to CIALIS®, tadalafil or ADCIRCA®, or any of its ingredients

When should I call my primary provider?

Call your primary provider right away if you: 

• Have an erection that lasts longer than 4 hours

• Experience a sudden loss of vision in one or both of your eyes

• Experience a sudden decrease or loss hearing

• Take too much CIALIS® or generic CIALIS® 

• Have an allergic reaction to CIALIS® or generic CIALIS®

• Symptoms of an allergic reaction may include: 

  • Rash 

  • Hives 

  • Swelling of the lips, tongue, or throat 

  • Difficulty breathing or swallowing 

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above. 

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

What Should I Tell My Roman-affiliated Provider Before Taking CIALIS® and generic CIALIS®? 

Tell your Roman-affiliated provider about all your medical problems, including if you: 

• Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take CIALIS® and generic CIALIS® if your healthcare provider has told you not to have sexual activity because of your health problems. 

• Have pulmonary hypertension

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

• Have had a stroke 

• Have liver problems 

• Have kidney problems or require dialysis 

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

• Have ever had severe vision loss, including a condition called NAION 

• Have stomach or intestinal ulcers 

• Have a bleeding problem 

• Have a deformed penis shape or Peyronie’s disease 

• Have had an erection that lasted more than 4 hours 

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

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

Especially tell your healthcare provider if you take any of the following: 

• Medicines called nitrates 

• Medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension 

• Medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), 4 Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS® or generic CIALIS® is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.

• Other medicines to treat high blood pressure (hypertension) 

• Medicines called HIV protease inhibitors, such as ritonavir (Norvir® , Kaletra® )

• Oral antifungals such as ketoconazole (Nizoral® ), itraconazole (Sporanox® ) 

• Antibiotics such as clarithromycin (Biaxin® ), telithromycin (Ketek® ), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine). 

• Other medicines or treatments for ED. 

• Tadalafil is also marketed as ADCIRCA® for the treatment of pulmonary arterial hypertension. Do not take both CIALIS® or generic CIALIS® and ADCIRCA®. Do not take sildenafil citrate (Revatio®, Viagra®) with CIALIS® or generic CIALIS®. 

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

What are the most common side effects of CIALIS® or generic CIALIS®?

The most common side effects with CIALIS® and generic CIALIS® are:

• Headache

• Indigestion

• Back pain

• Muscle aches

• Flushing

• Stuffy or runny nose. 

What is the FDA-approved Use of CIALIS® and generic CIALIS®? 

CIALIS® and generic CIALIS® are prescription medicines used to treat erectile dysfunction (ED), symptoms of benign  prostatic hyperplasia (BPH), or both.

Roman-affiliated doctors may prescribe CIALIS® for the treatment of premature ejaculation (PE), if they believe in their medical judgment that it is an appropriate course of treatment.  

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

Please see the full Prescribing Information for complete safety information.