BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
Approved Uses
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 for a short period of time (temporary).
BOTOX Cosmetic is a prescription medicine that is injected into the area around the side of the eyes to improve the look of moderate to severe crow’s feet lines in adults for a short period of time (temporary).
Important Safety Information
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 any time (hours to weeks) after injection of BOTOX Cosmetic:
1) 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.
2) Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serous symptoms including: loss of strength and all-over muscle weakness, 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. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
BOTOX Cosmetic (onabotulinumtoxinA) Important Safety Information (continued)
The dose of BOTOX Cosmetic is 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 or both at the same time.
They 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.
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 skin infection at the planned injection site.
such as amyotrophic lateral sclerosis (ALS or Lou Gehrig’s diseases), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX Cosmetic.
plans to have surgery; had surgery on your face; weakness of forehead muscles, such as 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 breast-feed (it is not known if BOTOX Cosmetic passes into breast milk).
including prescription and nonprescription medicines, vitamins and herbal products. 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.
Especially 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 Myoblock®, Dyspon® or Xeomin® in the past (be sure your doctor knows 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 anti-platelets (aspirin-like products) or anti-coagulants (blood thinners).
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.
For more information refer to the Medication Guide or talk with your doctor.
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