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For more information about ADCIRCA, please call Customer Service at 1-844-UNITHER (1-844-864-8437).

Reporting adverse events (side effects)

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

ADCIRCA® (tadalafil) is a prescription medication used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

Important Safety Considerations for ADCIRCA® (tadalafil)

You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA
Do not take ADCIRCA if you take any medications that contain nitrates
Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir

Important Safety Considerations for ADCIRCA® (tadalafil)

You should discuss all of your medical conditions and all medications with your healthcare provider before starting ADCIRCA
Do not take ADCIRCA if you take any medications that contain nitrates (often used for chest pain) or guanylate cyclase stimulators, as the combination could cause a sudden, unsafe drop in blood pressure
Do not take ADCIRCA if you are allergic to tadalafil or any other ingredient in ADCIRCA
ADCIRCA is a type of medication called a phosphodiesterase 5 inhibitor (PDE-5i) that can cause blood vessels to widen, which may result in a decrease in blood pressure. If you have heart-disease or any problems with low blood pressure, tell your healthcare provider before taking ADCIRCA, as these conditions may be affected by the action of ADCIRCA
Talk with your healthcare provider if you are pregnant or planning to become pregnant or if you are breastfeeding or plan to breast feed.
If you have ever had blockage in the veins of your lungs, known as pulmonary veno-occlusive disease (PVOD), ADCIRCA is not recommended for you
Taking ADCIRCA with alcohol, or blood pressure medications, such as alpha-blockers, may lower blood pressure and cause hypotension (light-headedness or fainting)
Do not take ADCIRCA if you are taking rifampin (an antibiotic for certain bacterial infections), or antifungal medications, such as ketoconazole and itraconazole. If you require treatment with both ADCIRCA and ritonavir (Norvir®) at the same time, your dose of ADCIRCA will need to be adjusted. Inform your healthcare provider if you have kidney or liver problems before taking ADCIRCA
ADCIRCA contains the same ingredient (tadalafil) as Cialis®, which is used to treat erectile dysfunction (ED, impotence) and the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). If you are taking ADCIRCA, do not take Cialis or other PDE-5is
In rare cases, patients reported side effects such as decreased eyesight or loss of vision in one or both eyes (NAION), or sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you experience any of these side effects after taking ADCIRCA, seek medical attention right away
In rare cases, men taking PDE-5is (including tadalafil) for erectile dysfunction reported side effects such as an erection lasting more than four hours. If you experience a prolonged erection, seek medical attention right away
The most common side effects of ADCIRCA are headache, muscle pain, getting red or hot in the face (flushing), nausea, pain in the arms, legs or back, upset stomach, stuffy or congested nose

ADC.ISI.CON.SEP2020

For more information about ADCIRCA, please see the Full Prescribing Information and Patient Information or call 1-800-545-5979.

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.