MEDICATION GUIDE BOTOX®
What is the most important information I should know about BOTOX and BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may cause serious side effects that can be life threatening, including:
Problems breathing or swallowing
Spread of toxin effects
These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX or BOTOX Cosmetic:
Problems swallowing, speaking, or breathing. These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX or BOTOX Cosmetic.
• People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with BOTOX or BOTOX Cosmetic.
• Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving BOTOX or BOTOX Cosmetic have the highest risk of getting these problems.
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
o loss of strength and muscle weakness all over the body
o double vision, blurred vision and drooping eyelids
o hoarseness or change or loss of voice (dysphonia)
o trouble saying words clearly (dysarthria)
o loss of bladder control
o trouble breathing
o trouble swallowing
These symptoms can happen hours, days, to weeks after you receive an injection of BOTOX or BOTOX Cosmetic. These problems could make it unsafe for you to drive a car or do other dangerous activities.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
• Infection at the injection site