Risks & Complications
BOTOX® Cosmetic may cause serious side effects that can be life threatening. It is important the you ensure BOTOXis administered by a properly qualified physician or a nurse under a physician supervision.
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:
Bleeding, which in rare instances could require hospitalization and blood transfusion. Blood clotsmay form under the skin and require drainage.
You are at the highest risk if these problems are pre-existing before injection.
Swallowing problems may last for several months
Spread of toxin effects.
The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including:
Are healthy and do not have a medical condition that can impair healing
Are physically healthy and are at a relatively normal weight
Have breast development that has stabilized
Are embarrassed or concerned by enlarged breasts
Experience physical discomfort from oversized breasts
Have a condition has lasted 12 months or longer
Are non-smokers and non-drug users
Have good skin elasticity
Have a positive outlook and specific goals regarding improving their physical symptoms of gynecomastia
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. Serious and/or immediate allergic reactions have been reported. 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.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (seeMedication 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 amyotrophic lateral sclerosis (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; 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).
Tell your doctor about all the medicines you take, 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 Myobloc®, Dysport®, 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 aspirin-like products or blood thinners.
