Indications
BOTOX
® is a prescription medicine that is injected into muscles and
used:
- 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).
IMPORTANT SAFETY INFORMATION
BOTOX® and BOTOX® Cosmetic 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 after treatment with BOTOX® or BOTOX®
Cosmetic:
- Problems swallowing, speaking, or breathing. These problems can happen hours
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
- Swallowing problems may last for several months. People who already have swallowing
or breathing problems before receiving BOTOX® or BOTOX®
Cosmetic have the highest risk of getting these problems
- 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, and trouble swallowing
These symptoms can happen hours 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?” in Medication Guide.
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 severe underarm sweating, blepharospasm, or strabismus, or when BOTOX®
Cosmetic has been used at the recommended dose to treat frown lines.
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).
Tell your doctor about all the medicines you take, including prescription
and nonprescription medicines, vitamins, and herbal products.
BOTOX® and BOTOX® Cosmetic can cause serious side effects.
Other side effects of BOTOX® and BOTOX® Cosmetic include:
dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain,
and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids,
swelling of your eyelids, and dry eyes. 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 wheezing 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.
For additional information refer to 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.
Please see
full product information, including
Medication Guide about BOTOX®.
Please see
full product information, including
Medication Guide about BOTOX® Cosmetic.