FDA ALERT [07/2005]: 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:
have heart disease
are over 50 years old
have diabetes
have high blood pressure
have high cholesterol
smoke
have certain eye problems
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. Continue reading......
Cialis FDA Approved 2003
Patient Information Sheet Revised 07/2005
This is a summary of the most important information about Cialis. For details, talk to your healthcare professional.
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