Summary of Information about BOTOX®
(onabotulinumtoxinA)
What is the most important information
I should know about BOTOX®?
BOTOX® may cause serious side effects that
can be life threatening. Call your doctor or get
medical help right away if you have any of these
problems any time (hours to weeks) after injection
of BOTOX®:
• � Problems swallowing, speaking, or breathing, due
to weakening of associated muscles, can be severe
and result in loss of life. You are at the highest risk
if these problems are pre-existing before injection.
Swallowing problems may last for several months.
• � Spread of toxin effects. The effect of botulinum
toxin may affect areas away from the injection
site and cause serious symptoms including:
loss of strength and all-over muscle weakness,
double vision, blurred vision and drooping eyelids,
hoarseness or change or loss of voice, trouble
saying words clearly, loss of bladder control,
trouble breathing, trouble swallowing.
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.
BOTOX® may cause loss of strength or general
muscle weakness, vision problems, or dizziness
within hours to weeks of taking BOTOX®. If this
happens, do not drive a car, operate machinery, or
do other dangerous activities.
BOTOX® dosing units are not the same as, or
comparable to, any other botulinum toxin product.
What is BOTOX®?
BOTOX® is prescription medicine a medical professional
injects into muscles 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 in people 18 years and older.
It is not known whether BOTOX® is safe or effective
to prevent headaches in people with migraine
who have 14 or fewer headache days each month
(episodic migraine).
Who should not take BOTOX®?
Do not use BOTOX® if you are: allergic to any of
the ingredients in BOTOX® such as botulinum
toxin type A and human serum albumin; had
an allergic reaction to another botulinum toxin
product such as Myobloc® (rimabotulinumtoxinB),
Dysport® (abobotulinumtoxinA), or Xeomin®
(incobotulinumtoxinA); or have a skin infection at the
planned injection site.
What should I tell my doctor before treatment?
Tell your doctor about all your muscle or nerve
conditions, such as amyotrophic lateral sclerosis
(L