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.[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]
