Adcirca Side Effects

Generic name: tadalafil

Note: This document contains side effect information about tadalafil. Some of the dosage forms listed on this page may not apply to the brand name Adcirca.

Some side effects of Adcirca may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to tadalafil: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking tadalafil (the active ingredient contained in Adcirca) 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 of tadalafil 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.

For Healthcare Professionals

Applies to tadalafil: oral tablet

Cardiovascular

Cardiovascular side effects have included angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, and tachycardia.

Dermatologic

Dermatologic side effects have included pruritus, rash, and sweating.

Gastrointestinal

Gastrointestinal side effects have included dyspepsia, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, loose stools, nausea, upper abdominal pain, and vomiting.

General

General side effects have included asthenia, face edema, facial flushing, fatigue, and pain in a limb.

Genitourinary

Genitourinary side effects have included increased erection and spontaneous penile erection.

Hepatic

Hepatic side effects have included abnormal liver function tests such as an increased GGTP.

Musculoskeletal

Musculoskeletal side effects have included back pain or myalgia, arthralgia, and neck pain.

Respiratory

Respiratory side effects have included nasal congestion, dyspnea, epistaxis, pharyngitis, nasopharyngitis, upper respiratory tract infection, and bronchitis.

Nervous system

Nervous system side effects have included headache, dizziness, hypesthesia, insomnia, paresthesia, somnolence, migraine and vertigo. Postmarketing experience has included seizure and seizure recurrence and transient global amnesia.

Ocular

Ocular side effects have included blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, increased lacrimation, and swelling of the eyelids.

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including tadalafil.

Other

Other side effects have included cases of sudden decrease or loss of hearing reported postmarketing in temporal association with the use of PDE5 inhibitors, including tadalafil (the active ingredient contained in Adcirca) In some 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.

Hypersensitivity

Hypersensitivity side effects have included Stevens-Johnson syndrome and exfoliative dermatitis.

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