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
IMPORTANT SAFETY INFORMATION
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
after treatment with BOTOX®:
- Problems swallowing, speaking, or breathing. These problems can happen hours
to weeks after an injection of BOTOX®, 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®
- Swallowing problems may last for several months. People who already have swallowing
or breathing problems before receiving BOTOX® 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
®.
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
®?” 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® can cause serious side effects. Other side effects of BOTOX®
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
® 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
®. 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
®. If you would like more
information, talk with your doctor.
Please see
full product information, including
Medication Guide about BOTOX®.