BOTOX® Cosmetic (onabotulinumtoxinA) may cause serious side effects that can be life threatening. Call your doctor of get medical help right away of you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
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 per-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: 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.
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 (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc© (rimabotulinumtoxinB), Dysport© (abobotulinumtoxinA), or Xeomin© (incobtulinumtoxinA); 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 increased risk of serious effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of Botox© Cosmetics.
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).
Human albumin and spread of viral diseases. Botox© Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg, Creutzfeldt-Jakob disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin.
Tell your doctor about all the medications 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.
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, swelling of your eyelids, and dry eyes.
For more information refer to the medication Guide or talk with your doctor.