Adcirca Generic Name: tadalafil tablets Brand Name: Adcirca Drug Class: PAH, PDE-5 Inhibitors, Phosphodiesterase-5 Enzyme Inhibitors Adcirca (Tadalafil Tablets) side effects drug center Related Drugs Alyq Flolan Letairis Remodulin Tracleer Tyvaso Uptravi Ventavis Health Resources Pulmonary Hypertension PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Adcirca Side Effects Center What Is Adcirca? Adcirca (tadalafil) is a phosphodiesterase-5 (PDE5) inhibitor used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. The Cialis brand of tadalafil is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). What Are Side Effects of Adcirca? Common side effects of Adcirca include: flushing (redness or warmth in your face, neck, or chest), cold symptoms (such as stuffy nose, sneezing, or sore throat), headache, memory problems, diarrhea, upset stomach, muscle pain, or back pain. Contact your doctor if you have serious side effects of Adcirca including: chest pain, shortness of breath, seizures (convulsions), lightheadedness or fainting, changes in vision or sudden hearing loss, ringing in your ears, pain spreading to the arm or shoulder, irregular heartbeat, or an erection lasting 4 hours or more. Dosage for Adcirca? The recommended dose of Adcirca is 40 mg (two 20 mg tablets) taken once daily with or without food. What Drugs, Substances, or Supplements Interact with Adcirca? Adcirca may interact with rifabutin, rifampin, rifapentine, antibiotics, antifungals, antidepressants, barbiturates, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, HIV or AIDS medications, or seizure medications. Tell your doctor all medications and supplements you use. Adcirca During Pregnancy and Breastfeeding Adcirca is not expected to harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Adcirca. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding. Additional Information Our Adcirca (tadalafil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Adcirca Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using tadalafil and call your doctor at once 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; ringing in your ears or sudden hearing loss; or an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis). Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect. Common side effects may include: headache; flushing (warmth, redness, or tingly feeling); nausea, upset stomach; runny or stuffy nose; or muscle pain, back pain, pain in your arms, legs, or back. 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. Read the entire detailed patient monograph for Adcirca (Tadalafil Tablets) Adcirca Professional Information SIDE EFFECTSThe following serious adverse reactions are discussed elsewhere in the labeling:Hypotension [see WARNINGS AND PRECAUTIONS]Visual Loss [see WARNINGS AND PRECAUTIONS and Patient Counseling Information]Hearing loss [see WARNINGS AND PRECAUTIONS]Priapism [see WARNINGS AND PRECAUTIONS]Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of ADCIRCA, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively. The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for ADCIRCA 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with ADCIRCA 40 mg was 4% compared to 5% in placebo-treated patients.In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the ADCIRCA 40 mg group and occurring more frequently than with placebo.Table 1: Treatment-Emergent Adverse Events Reported by ≥9% of Patients in ADCIRCA and More Frequent than Placebo by 2%EVENTPlacebo (%)(N=82)ADCIRCA 20 mg(%)(N=82)ADCIRCA 40 mg(%)(N=79)Headache153242Myalgia4914Nasopharyngitis7213Flushing2613Respiratory Tract Infection (Upper and Lower)6713Pain in Extremity2511Nausea61011Back Pain61210Dyspepsia21310Nasal Congestion (Including sinus congestion)109Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section.Cardiovascular and cerebrovascular - Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS].Body as a whole - Hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitisNervous - Migraine, seizure and seizure recurrence, and transient global amnesiaOphthalmologic - Visual field defect, retinal vein occlusion, retinal artery occlusion, and NAION [see WARNINGS AND PRECAUTIONS and Patient Counseling Information].Otologic - Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of tadalafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONS and Patient Counseling Information].Urogenital - Priapism [see WARNINGS AND PRECAUTIONS]. Read the entire FDA prescribing information for Adcirca (Tadalafil Tablets) &Copy; Adcirca Patient Information is supplied by Cerner Multum, Inc. and Adcirca Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
