HeadWise Volume 4, Issue 3 | Page 24

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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HeadW ise ®

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Volume 4, Issue 3 • 2015

• 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 pe ople younger than:
• 18 years of age for treatment of urinary
incontinence
• 18 years of age for treatment of chronic
migraine
• 18 years of age for treatment of spasticity
• 16 years of age for treatment of cervical
dystonia
• 18 years of age for treatment of
hyperhidrosis
• 12 years of age for treatment of
strabismus or blepharospasm
BOTOX Cosmetic is not recommended for
use in children younger than 18 years of age.
It is not known whether BOTOX and
BOTOX Cosmetic are safe or effective to
prevent headaches in people with migraine
who have 14 or fewer headache days each
month (episodic migraine).
It is not known whether BOTOX and
BOTOX Cosmetic are safe or effective for
other types of muscle spasms or for severe
sweating anywhere other than your armpits.
Who should not take BOTOX or
BOTOX Cosmetic?
Do not take BOTOX or BOTOX Cosmetic
if you:
• are allergic to any of the ingredients
in BOTOX or BOTOX Cosmetic. See the
end of this Medication Guide for a list of
ingredients in BOTOX and BOTOX Cosmetic.
• had an allergic reaction to any other
botulinum toxin product such as Myobloc ®,
Dysport ®, or Xeomin ®
• have a skin infection at the planned
injection site
• are being treated for urinary incontinence
and have a urinary tract infection (UTI)
• are being treated for urinary incontinence
and find that you cannot empty your
bladder on your own (only applies to people
who are not routinely catheterizing)
What should I tell my doctor before taking
BOTOX or BOTOX Cosmetic?

Tell your doctor about all your medical
conditions, including if you:
• have a disease that affects your muscles
and nerves (such as amyotrophic lateral
sclerosis [ALS or Lou Gehrig’s disease],
myasthenia gravis or Lambert-Eaton
syndrome). See “What is the most important
information I should know about BOTOX and
BOTOX Cosmetic?”
• have allergies to any botulinum toxin product
• had any side effect from any botulinum
toxin product in the past
• have or have had a breathing problem, such
as asthma or emphysema
• have or have had swallowing problems
• have or have had bleeding problems
• have plans to have surgery
• had surgery on your face
• have weakness of your forehead muscles,
such as trouble raising your eyebrows
• have drooping eyelids
• have any other change in the way your face
normally looks
• have symptoms of a urinary tract infection
(UTI) and are being treated for urinary
incontinence. Symptoms of a urinary tract
infection may include pain or burning with
urination, frequent urination, or fever.
• have problems emptying your bladder on
your own and are being treated for urinary
incontinence
• are pregnant or plan to become pregnant.
It is not known if BOTOX or BOTOX Cosmetic
can harm your unborn baby.
• are breast-feeding or plan to breastfeed. It
is not known if BOTOX or BOTOX Cosmetic
passes into breast milk.
Tell your doctor about all the medicines
you take, including prescription and
nonprescription medicines, vitamins and
herbal products. Using BOTOX or
BOTOX Cosmetic with certain other
medicines may cause serious side effects.
Do not start any new medicines until you
have told your doctor that you have received
BOTOX or BOTOX Cosmetic in the past.
Especially tell your doctor if you:
• have received any other botulinum toxin
product in the last four months
• have received injections of botulinum toxin,
such as Myobloc ® (rimabotulinumtoxinB),
Dysport ® (abobotulinumtoxinA), or Xeomin ®
(incobotulinumtoxinA) in the past. Be sure
your doctor knows exactly which product
you received.
• have recently received an antibiotic by
injection
• take muscle relaxants
• take an allergy or cold medicine

• take a sleep medicine
• take anti-platelets (aspirin-like products)
and/or anti-coagulants (blood thinners)
Ask your doctor if you are not sure if your
medicine is one that is listed above.
Know the medicines you take. Keep a list
of your medicines with you to show your
doctor and pharmacist each time you get a
new medicine.
How should I take BOTOX or
BOTOX Cosmetic?
• BOTOX or BOTOX Cosmetic is an injection
that your doctor will give you.
• BOTOX is injected into your affected
muscles, skin, or bladder.
• BOTOX Cosmetic is injected into your
affected muscles.
• Your doctor may change your dose of
BOTOX or BOTOX Cosmetic, until you and
your doctor find the best dose for you.
• Your doctor will tell you how often you
will receive your dose of BOTOX or
BOTOX Cosmetic injections.
What should I avoid while taking BOTOX
or BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may
cause loss of strength or general muscle
weakness, or vision problems within
hours to weeks of taking BOTOX or
BOTOX Cosmetic. If this happens, do not
drive a car, operate machinery, or do other
dangerous activities. See “What is the most
important information I should know about
BOTOX and BOTOX Cosmetic?”
What are the possible side effects of
BOTOX and BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic can cause
serious side effects. See “What is the most
important information I should know about
BOTOX and BOTOX Cosmetic?”
Other side effects of BOTOX and BOTOX
Cosmetic include:
• dry mouth
• discomfort or pain at the injection site
• tiredness
• headache
• neck pain
• eye problems: double vision, blurred
vision, decreased eyesight, drooping eyelids,
swelling of your eyelids, and dry eyes.
• urinary tract infection in people being
treated for urinary incontinence
• painful urination in people being treated for
urinary incontinence
• inability to empty your bladder on your own
and are being treated for urinary incontinence.
If you have difficulty fully emptying your
bladder after getting BOTOX, you may need
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to use disposable self-catheters to empty your
bladder up to a few times each day until your
bladder is able to start emptying again.
• allergic reactions. Symptoms of an allergic
reaction to BOTOX or BOTOX Cosmetic
may include: itching, rash, red itchy welts,
wheezing, asthma symptoms, or dizziness or
feeling faint. Tell your doctor or get medical help
right away if you are whee zing or have asthma
symptoms, or if you become dizzy or faint.
Tell your doctor if you have any side effect that
bothers you or that does not go away.
These are not all the possible side effects
of BOTOX and BOTOX Cosmetic. For more
information, ask your doctor or pharmacist.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088.
General information about BOTOX and
BOTOX Cosmetic:
Medicines are sometimes prescribed
for purposes other than those listed in a
Medication Guide.
This Medication Guide summarizes the
most important information about BOTOX
and BOTOX Cosmetic. If you would like
more information, talk with your doctor.
You can ask your doctor or pharmacist
for information about BOTOX and
BOTOX Cosmetic that is written for
healthcare professionals.
What are the ingredients in BOTOX and
BOTOX Cosmetic?
Active ingredient: botulinum toxin type A
Inactive ingredients: human albumin and
sodium chloride
This Medication Guide has been approved by
the U.S. Food and Drug Administration.
Manufactured by: Allergan Pharmaceuticals
Ireland a subsidiary of: Allergan, Inc.
2525 Dupont Dr.
Irvine, CA 92612
Revised: 09/2013
© 2013 Allergan, Inc.
®
marks owned by Allergan, Inc.
Myobloc ® is a registered trademark
of Solstice Neurosciences, Inc.
Dysport ® is a registered trademark
of Ipsen Biopharm Limited Company.
Xeomin ® is a registered trademark
of Merz Pharma GmbH & Co KGaA.
Patented. See: www.allergan.com/products/
patent_notices

Based on 72284US16
APC13NF13
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National Headache Foundation

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