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Nerve and Muscle Blocks
Procedure
side effects
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
• 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 leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease.
• 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 younger than 65 years of age for a short period of time (temporary).
It is not known whether BOTOX
is safe or effective in people 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.
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