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Adcirca

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Adcirca

Adcirca

Adcirca Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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). Common side effects include 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; or muscle pain, back pain.

The recommended dose of Adcirca is 40 mg (two 20 mg tablets) taken once daily with or without food. 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 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.

Our Adcirca (tadalafil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Adcirca in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

If you become dizzy or nauseated during sexual activity, or if you have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil.

Stop using tadalafil and call your doctor at once if you have any of these serious side effects:

  • changes in vision or sudden vision loss;
  • ringing in your ears, or sudden hearing loss;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • irregular heartbeat;
  • shortness of breath, swelling in your hands or feet;
  • seizure (convulsions);
  • feeling light-headed, fainting; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • 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; or
  • muscle pain, back pain.

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) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Adcirca FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Because 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%

EVENT  Placebo (%)
(N=82) 
ADCIRCA 20 mg (%)
(N=82) 
ADCIRCA 40 mg (%)
(N=79) 
Headache  15 32 42
Myalgia  4 9 14
Nasopharyngitis  7 2 13
Flushing  2 6 13
Respiratory Tract Infection (Upper and Lower)  6 7 13
Pain in Extremity  2 5 11
Nausea  6 10 11
Back Pain  6 12 10
Dyspepsia  2 13 10
Nasal Congestion (Including sinus congestion)  1 0 9

Postmarketing Experience

The 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 dermatitis

Nervous - Migraine, seizure and seizure recurrence, and transient global amnesia

Ophthalmologic - Visual field defect, retinal vein occlusion, and retinal artery occlusion

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 INFORMATION].

Urogenital - Priapism [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Adcirca (Tadalafil Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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