Patient Information Sheet
Vardenafil hydrochloride (marketed as Levitra)
The issue described in the Alert has been addressed in product labeling; please see Drugs@FDA
This is a summary of the most important information
about Levitra. For details, talk to your healthcare professional.
FDA ALERT [7/2005]: A small number of men have
lost eyesight in one eye some time after taking Levitra, Viagra, or
Cialis. This type of vision loss is called non-arteritic anterior
ischemic optic neuropathy (NAION). NAION causes a sudden loss of
eyesight because blood flow is blocked to the optic nerve.
We do not know at this time if Levitra, Viagra, or Cialis cause
NAION. NAION also happens in men who do not take these medicines.
People who have a higher chance for NAION include those who:
FDA has approved new labels for Levitra, Viagra,
and Cialis to include information on possible eyesight loss (NAION).
Stop using Levitra, Viagra, or Cialis if you have a loss in your
eyesight. Get medical help right away.
This information reflects FDA’s current
analysis of data available to FDA concerning this drug. FDA intends
to update this sheet when additional information or analyses become
What is Levitra?
Levitra is a medicine taken by mouth for the treatment of erectile
dysfunction (ED) in men. ED is a condition where the penis does not
harden and expand when a man is sexually excited, or when he cannot
keep an erection. Levitra may help a man with ED get and keep an
erection when he is sexually excited. Levitra must be used only
under a doctor's care.
Levitra does not:
increase a man’s sexual desire
protect a man or his partner from sexually
transmitted diseases, including HIV. Speak to your healthcare
professional about ways to guard against sexually transmitted
serve as a male form of birth control
Levitra is only for men with ED. Levitra is not for
women or children. Levitra must be used only under a healthcare
Who Should Not Take Levitra?
Do not take Levitra if you:
take any medicines called “nitrates”
use recreational drugs called "poppers" like amyl
nitrate and butyl nitrate
have been told by your healthcare professional not
to have sexual activity because you have health problems
What are The Risks?
The following are the major possible risks and
side effects of Levitra therapy. This list is not complete.
Levitra can cause your blood pressure to drop suddenly to an unsafe
level if it is taken with certain other medicines such as nitrates
and alpha-blockers, and recreational drugs that contain nitrates
called "poppers". A sudden drop in your blood pressure could cause
you to become dizzy, faint, or have a heart attack or stroke.
Tell all your healthcare professionals that you take Levitra. If you
need emergency medical care for a heart problem, it will be
important for your healthcare professionals to know when you last
Levitra may uncommonly cause:
an erection that won’t go away (priapism)
vision changes, such as seeing a blue tinge to
objects or having difficulty telling the difference between the
colors blue and green
Some common side effects with Levitra include:
stuffy or runny nose
What Should I Tell My Healthcare
Tell your healthcare professional if you:
have or had heart problems
have low blood pressure or have high blood pressure
that is not controlled
have had a stroke
or any family members have a rare heart condition
known as prolongation of the QT interval (long QT syndrome)
have liver problems
have kidney problems and require dialysis
have ever had severe vision loss
have retinitis pigmentosa, a rare genetic (runs in
families) eye disease
have stomach ulcers
have a bleeding problem
have a deformed penis shape or Peyronie’s disease
have had an erection that lasted more than 4 hours
take any medicines called “alpha blockers” (alpha
blockers are sometimes prescribed for prostate problems or high
have blood cell problems, such as sickle cell
anemia, multiple myeloma, or leukemia
Can Other Medicines or Food Affect
Levitra and certain other medicines can interact with each other.
Tell your healthcare professional about all the medicines you take
including prescription and non-prescription medicines, vitamins, and
herbal supplements. Know the medicines you take. Keep a list of them
with you to show your healthcare professional.
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Date created: July 8, 2005, updated October 2, 2007