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Vardenafil Side Effects

It is possible that some side effects of vardenafil may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to vardenafil: oral tablet, oral tablet disintegrating

As well as its needed effects, vardenafil may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking vardenafil, check with your doctor immediately:

Less common
  • Arm, back, or jaw pain
  • blindness
  • blurred vision
  • chest pain or discomfort
  • 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 from a lying or sitting position
  • eye pain
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • hives
  • itching
  • 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
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sweating
  • tearing
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Incidence not known
  • Hearing loss

Some vardenafil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
  • abdominal or stomach pain
  • 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
  • itching skin
  • 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
  • pain or burning in the throat
  • runny nose
  • sensation of spinning
  • shivering
  • sleepiness or unusual drowsiness
  • sleeplessness
  • 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
  • unable to sleep
  • 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]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Levitra (vardenafil)." Bayer, West Haven, CT.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Staxyn (vardenafil)." Merck & Company Inc, Whitehouse Station, NJ.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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