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 and/or crow’s feet 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 adults with
chronic migraine who have 15 or more
days each month with headache lasting
4 or more hours each day.
• to treat increased muscle stiffness in
elbow, wrist, and finger muscles in adults
with upper limb spasticity.
• to treat the abnormal head position
and neck pain that happens with cervical
dystonia (CD) in adults.
• to treat certain types of eye muscle
problems (strabismus) or abnormal spasm
of the eyelids (blepharospasm) in people
12 years and older.
BOTOX is also injected into the skin to
treat the symptoms of severe underarm
sweating (severe primary axillary
hyperhidrosis) when medicines used on
the skin (topical) do not work well enough.
BOTOX Cosmetic is a prescription medicine
that is injected into muscles and used to
improve the look of moderate to severe frown
lines between the eyebrows (glabellar lines) in
adults for a short period of time (temporary).
BOTOX Cosmetic is a prescription medicine
that is injected into the area around the side
of the eyes to improve the look of crow’s
feet lines in adults for a short period of time
(temporary).
You may receive treatment for frown lines
and crow’s feet lines at the same time.
It is not known whether BOTOX is safe or
effective in people younger than:
• 18 years