MEDICATION GUIDE
BOTOX® and BOTOX® Cosmetic
(Boe-tox) (onabotulinumtoxinA)
for Injection
Read the Medication Guide that comes
with BOTOX or BOTOX Cosmetic before
you start using it and each time it is given
to you. There may be new information.
This information does not take the place of
talking with your doctor about your medical
condition or your treatment. You should
share this information with your family
members and caregivers.
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:
1. 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.
2. 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:
• loss of strength and muscle weakness
all over the body
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• double vision
• blurred vision and drooping eyelids
• hoarseness or change or loss of voice
(dysphonia)
• trouble saying words clearly (dysarthria)
• loss of bladder control
• trouble breathing
• 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. See “What should I avoid while
receiving BOTOX or BOTOX Cosmetic?”
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.
What are BOTOX and BOTOX Cosmetic?
BOTOX is a prescription medicine that is
injected into muscles and used:
• to treat overactive bladder symptoms
such as a strong need to urinate with
leaking or wetting accidents (urge urinary
incontinence), a strong need to urinate
right away (urgency), and urinating often
(frequency) in adults when another type of
medicine (anticholinergic) does not work
well enough or cannot be taken.
• to treat leakage of urine (incontinence)
in adults with overactive bladder due to
neurologic disease when another type of
medicine (anticholinergic) does not work
well enough or cannot be taken.
• to prevent headaches in adult