Summary

Commonly reported side effects of vardenafil include: headache and flushing. Other side effects include: dyspepsia and rhinitis. Continue reading for a comprehensive list of adverse effects.

Applies to vardenafil: oral tablet, oral tablet disintegrating.

Serious side effects of Vardenafil

Along with its needed effects, vardenafil may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vardenafil:

Less common

• Arm, back, or jaw pain
• blindness
• blurred vision
• chest pain, discomfort, or tightness
• chest tightness or heaviness
• chills
• cold sweats
• confusion
• decreased vision
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• eye pain
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• headache
• hives, itching, or skin rash
• nausea
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or fast heartbeat
• sweating
• tearing
• unusual tiredness or weakness
• vomiting

Incidence not known

• Hearing loss

Other side effects of Vardenafil

Some side effects of vardenafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
• sneezing
• stuffy nose

Less common

• Abnormal ejaculation
• abnormal vision
• acid or sour stomach
• back pain
• belching
• bloody nose
• body aches or pain
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in color vision
• changes in vision
• congestion
• cough
• diarrhea
• difficulty seeing at night
• difficulty with moving
• difficulty with swallowing
• dim vision
• dry mouth
• dryness or soreness of the throat
• excessive muscle tone
• eye pain
• face swelling
• fast heartbeat
• feeling of constant movement of self or surroundings
• fever
• general feeling of discomfort or illness
• heartburn
• hoarseness
• increased redness of the eye
• increased sensitivity of the eyes to sunlight
• indigestion
• joint pain
• lack or loss of strength
• loss of appetite
• muscle aches and pains
• muscle cramping
• muscle stiffness
• muscle tension or tightness
• neck pain
• pain or burning in the throat
• runny nose
• sensation of spinning
• shivering
• sleepiness or unusual drowsiness
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stomach discomfort, upset, or pain
• swollen joints
• tender, swollen glands in the neck
• tenderness in the stomach area
• trouble with sleeping
• trouble with swallowing
• voice changes
• watery eyes

For Healthcare Professionals

Applies to vardenafil: oral tablet, oral tablet disintegrating.

General

The most commonly reported adverse reaction is headache.^[Ref]

Cardiovascular

Very common (10% or more): Flushing (11%)

Common (1% to 10%): Palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension

Rare (less than 0.1%): Hypertension

Postmarketing reports: Serious cerebrovascular hemorrhage, sudden cardiac death, transient ischemic attack, unstable angina and ventricular arrhythmia have been reported in temporal association with another medicinal product in this class.^[Ref]

Nervous system

Very common (10% or more): Headache (15%)

Common (1% to 10%): Dizziness, paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure

Postmarketing reports: Seizure, seizure recurrence, transient global amnesia^[Ref]

Dermatologic

Common (1% to 10%): Erythema, rash, angioedema, allergic edema

Rare (less than 0.1%): Photosensitivity reaction^[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Increase in erection

Rare (less than 0.1%): Priapism

Postmarketing reports: Penile hemorrhage, hematospermia^[Ref]

Hepatic

Common (1% to 10%): Increase in transaminases

Rare (less than 0.1%) Increase in gamma-glutamyl-transferase^[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions

Musculoskeletal

Common (1% to 10%): Back pain, increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia^[Ref]

Ocular

Common (1% to 10%): Visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis

Rare (less than 0.1%): Increased lacrimation

Postmarketing reports: Non-arteritic anterior ischemic optic neuropathy (NAION), visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity.^[Ref]

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.^[Ref]

Other

Common (1% to 10%): Accidental injury, flu syndrome, tinnitus, vertigo, chest pain, feeling unwell

Postmarketing reports: Cases of sudden decrease or loss of hearing in temporal association with the use of PDE5 inhibitors, including this drug^[Ref]

Renal

Common (1% to 10%): Increased creatinine kinase

Postmarketing reports: Hematuria^[Ref]

Respiratory

Common (1% to 10%): Rhinitis, sinusitis, dyspnea, sinus congestion, nasal congestion

Rare (less than 0.1%): Epistaxis^[Ref]