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Patient Information Sheet
Tadalafil (marketed as Cialis)
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 Cialis. 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 Cialis, Viagra, or
Levitra. 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 Cialis, Viagra or Levitra causes
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 Cialis, Viagra,
and Levitra to include information on possible eyesight loss (NAION).
Stop using Cialis, Viagra, or Levitra 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
available.
What is Cialis?
Cialis is a prescription 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. Cialis may help a man with ED get
and keep an erection when he is sexually excited. Cialis must be
used only under a doctor’s care.
Cialis does not:
-
cure ED
-
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
diseases.
-
serve as a male form of birth control
Cialis is only for men with ED. Cialis is not for
women or children. Cialis must be used only under a healthcare
professional’s care.
Who Should Not Take Cialis?
Do not take Cialis 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 to
not have sexual activity because of health problems
What are The Risks?
The following are the major possible risks and
side effects of Cialis therapy. This list is not complete.
Cialis 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 Cialis. If you
need emergency medical care for a heart problem, it will be
important for your healthcare professionals to know when you last
took Cialis.
Cialis 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 Cialis include:
-
headache
-
indigestion
-
back pain
-
muscle aches
-
flushing
-
stuffy or runny nose
What Should I Tell My Healthcare
Professional?
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
-
have liver problems
-
have kidney problems or 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
-
have blood cell problems such as sickle cell anemia,
multiple myeloma, or leukemia
-
take medicines called “alpha blockers” (alpha
blockers are sometimes prescribed for prostate problems or high
blood pressure)
Can Other Medicines or Food Affect
Cialis?
Cialis 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 |
