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Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily
improve the look of moderate to severe forehead lines, crow’s feet lines, and frown lines between the eyebrows
in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get
medical help right away if you have any of these problems any time (hours to weeks) after injection of
BOTOX® Cosmetic:
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Problems swallowing, speaking, or breathing, due to weakening of associated
muscles, can be severe and result in loss of life. You are at the highest risk if
these problems are pre-existing before injection. Swallowing problems may last for several months.
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Spread of toxin effects. The effect of botulinum toxin may affect areas away
from the injection site and cause serious symptoms including: loss of strength
and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss
of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other
botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has
been used at the recommended dose to treat frown lines, crow’s feet lines, and/or forehead lines.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or
dizziness within hours to weeks of taking BOTOX® Cosmetic.
If this happens, do not drive a car, operate machinery, or do other dangerous
activities.
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 are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not receive BOTOX® Cosmetic if you: are allergic to any of
the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic
reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB),
Dysport®
(abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned
injection site.
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®
Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have
surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal
facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can
harm your unborn
baby); are breast-feeding or plan to (it is not known if BOTOX® Cosmetic passes into breast
milk).
Tell your doctor about all the medicines you take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Using 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® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received
injections of botulinum toxin such as Myobloc®, Dysport®, or
Xeomin® in the past (tell your doctor 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 aspirin-like products or blood thinners.
Other side effects of 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 and eyebrows, swelling of your eyelids and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-678-1605.
