BOTOX® is for adults with Chronic Migraine with 15 or more headache days a month, each lasting 4 hours or more. BOTOX® therapy is not approved for adults with migraine who have 14 or fewer headache days a month.
*BOTOX® prevents up to 9 headache days a month (vs up to 7 for placebo).
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.
Do not take BOTOX® if you: are allergic to any of the ingredients in BOTOX® (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myoblocy® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
The dose of BOTOX® is not the same as, or comparable to, another botulinum toxin product.
Serious and/or immediate allergic reactions have been reported. They include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX® should be discontinued.
Tell your doctor about all your muscle or nerve conditions such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX®.
Other side effects in the clinical study included:
BOTOX® (In 687 patients)
Placebo (In 692 patients)
Headache
5%
3%
Migraine
4%
3%
Partial facial paralysis
2%
0%
Drooping eyelids
4%
< 1%
Bronchitis
3%
2%
Neck pain
9%
3%
Musculoskeletal stiffness
4%
1%
Muscular weakness
4%
< 1%
Muscle pain
3%
1%
Musculoskeletal pain
3%
1%
Muscle spasms
2%
1%
Injection site pain
3%
2%
High blood pressure
2%
1%
These are not all the side effects of BOTOX®. Please see the Important Safety Information at the link below and talk to your doctor about the Summary of Information about BOTOX®.