Levitra Side Effects

Generic Name: vardenafil

Note: This page contains information about the side effects of vardenafil. Some of the dosage forms included on this document may not apply to the brand name Levitra.

Not all side effects for Levitra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to vardenafil: oral tablet, oral tablet disintegrating

In addition to its needed effects, some unwanted effects may be caused by vardenafil (the active ingredient contained in Levitra). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking vardenafil:

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 of the side effects that can occur with vardenafil may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

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.

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

Dermatologic

Common (1% to 10%): Erythema, rash, angioedema, allergic edema
Rare (less than 0.1%): Photosensitivity reaction

Gastrointestinal

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

Genitourinary

Uncommon (0.1% to 1%): Increase in erection
Rare (less than 0.1%): Priapism
Postmarketing reports: Penile hemorrhage, hematospermia

Hepatic

Common (1% to 10%): Increase in transaminases
Rare (less than 0.1%) Increase in gamma-glutamyl-transferase

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

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 (the active ingredient contained in Levitra)

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.

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

Renal

Common (1% to 10%): Increased creatinine kinase
Postmarketing reports: Hematuria

Respiratory

Common (1% to 10%): Rhinitis, sinusitis, dyspnea, sinus congestion, nasal congestion
Rare (less than 0.1%): Epistaxis

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