Vardenafil Side Effects

Some side effects of vardenafil 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 vardenafil: oral tablet, oral tablet disintegrating

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

During sexual activity, if you become dizzy or nauseated, or 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 vardenafil.

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

• 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;

• swelling in your hands, ankles, or feet;

• shortness of breath;

• vision changes;

• feeling light-headed, fainting;

• penis erection that is painful or lasts 4 hours or longer; or

• seizure (convulsions).

Less serious side effects of vardenafil may include:

• warmth or redness in your face, neck, or chest;

• runny or stuffy nose;

• headache, dizziness;

• upset stomach; or

• 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 vardenafil: oral tablet, oral tablet disintegrating

Cardiovascular

Cardiovascular side effects have included flushing (vasodilation) in 11% and dizziness in 2% of patients. Consistent with its known effects on the nitric oxide/cGMP pathway, use of sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently taking organic nitrates is considered contraindicated. The following cardiovascular side effects have been associated with the use of sildenafil in less than 2% of patients: angina pectoris, chest pain, hypertension, hypotension, myocardial ischemia, palpitation, postural hypotension, syncope, and tachycardia. Congenital or Acquired QT Prolongation: In a study on the effect of vardenafil on QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

Dermatologic

Dermatologic side effects have been reported in less than 2% of patients and include photosensitivity reaction, pruritus, rash, and sweating,

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (4%) and nausea (2%). Less common gastrointestinal complaints have included abdominal pain, diarrhea, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux and vomiting (less than 2% of patients).

Hepatic

Hepatic side effects have included increased creatine kinase (2%). Other hepatic side effects (less than 2%) have included other abnormal liver function tests.

Genitourinary

Genitourinary side effects have been reported in less than 2% of patients and included abnormal ejaculation and priapism (including prolonged or painful erections). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Musculoskeletal

Musculoskeletal side effects have been reported in less than 2% of patients. They include arthralgia, back pain, myalgia, and neck pain.

Nervous system

Nervous system side effects have included headache (16%) and dizziness (2%). Other nervous system side effects reported in less than 2% of patients have included hypertonia, hypesthesia, insomnia, paresthesia, somnolence, and vertigo. Seizure and seizure recurrence have been reported postmarketing in temporal association with vardenafil. Transient global amnesia has also been reported postmarketing in temporal association with vardenafil.

Ocular

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 vardenafil.

Ocular side effects have been reported in less than 2% of patients and have included abnormal vision, blurred vision, chromatopsia, changes in color vision, conjunctivitis, dim vision, eye pain, glaucoma, photophobia, and watery eyes.

Respiratory

Respiratory system side effects have included rhinitis (9%) and sinusitis (3%). Other respiratory system side effects that occurred in more than 2% of patients have included dyspnea, epistaxis, and pharyngitis.

Other

Other side effects have included tinnitus. Cases of sudden decrease or loss of hearing reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. 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 vardenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

General

General side effects have included accidental injury (3%) and flu syndrome (3%). Other side effects occurring in less than 2% of patients include: anaphylactic reaction (including laryngeal edema), asthenia, face edema and pain.

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