BOTOX® Cosmetic (onabotulinumtoxinA)

KEY SAFETY INFORMATION
BOTOX® Cosmetic can lead to severe side effects, some of which may be life-threatening. Seek immediate medical assistance if you experience any of the following issues at any point (from hours to weeks) after receiving BOTOX® Cosmetic:

Difficulty with swallowing, speaking, or breathing caused by muscle weakening. These effects can be severe and potentially fatal. People with these issues prior to treatment may be at a greater risk. Swallowing difficulties may persist for several months.
Spread of the toxin’s effects beyond the injection area may occur, causing serious complications such as loss of muscle strength, generalized weakness, double or blurry vision, eyelid drooping, changes in voice or hoarseness, unclear speech, urinary incontinence, and difficulty breathing or swallowing.
The dosage units for BOTOX® Cosmetic are unique and are not interchangeable with those of other botulinum toxin products.

There have been no confirmed cases of toxin spread when BOTOX® Cosmetic is used as directed to treat frown lines, crow’s feet, forehead lines, and/or platysma bands.

You may experience muscle weakness, vision issues, or dizziness within hours to weeks after receiving BOTOX® Cosmetic. If so, do not drive, operate machinery, or perform tasks that require alertness.

Severe allergic reactions, such as itching, rash, hives, wheezing, asthma-like symptoms, or fainting, have been reported. Seek emergency medical attention if you have trouble breathing, asthma symptoms, dizziness, or fainting.

Do not use BOTOX® Cosmetic if you are allergic to any of its ingredients (refer to the Medication Guide), have had an allergic reaction to another botulinum toxin product like Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), Xeomin® (incobotulinumtoxinA), Jeuveau® (prabotulinumtoxinA-xvfs), Daxxify® (daxibotulinumtoxinA-lanm), or Letybo® (letibotulinumtoxinA-wlbg), or if you have an infection at the intended injection site. This may not be a complete list of all botulinum toxin products.

Inform your doctor if you have any muscle or nerve disorders, such as ALS (Lou Gehrig’s disease), myasthenia gravis, or Lambert-Eaton syndrome, as these conditions may increase the risk of serious complications like difficulty breathing or swallowing after a standard BOTOX® Cosmetic dose.

Let your doctor know about your full medical history, especially if you’ve had or plan to have facial surgery, experience issues like raised eyebrows or drooping eyelids, or any other facial changes. Also, inform your doctor if you are pregnant, plan to become pregnant (it’s unknown if BOTOX® Cosmetic affects an unborn child), or are breastfeeding (it is not known if the product passes into breast milk).

List all medications, supplements, and over-the-counter products you’re taking. Certain medications may interact negatively with BOTOX® Cosmetic. Do not begin any new medication until you inform your doctor of your BOTOX® Cosmetic treatment.

Tell your doctor if you’ve used another botulinum toxin product within the past 4 months; have had injections of Myobloc®, Dysport®, Xeomin®, Jeuveau®, Daxxify®, or Letybo® (be specific about which one); or if you’ve recently received an injectable antibiotic, muscle relaxant, allergy/cold medicine, sleep aid, or blood thinner such as aspirin-like products.

Additional side effects may include dry mouth, discomfort at the injection site, fatigue, headache, neck pain, and vision-related issues such as blurry or double vision, decreased eyesight, drooping or swollen eyelids, and dry eyes.

Approved Indications
BOTOX® Cosmetic is a prescription injection used to temporarily reduce the appearance of moderate to severe forehead lines, crow’s feet, frown lines between the brows, and vertical platysma bands in adults.

For additional information, consult the Medication Guide or speak with your physician.

To report side effects, call Allergan Aesthetics at 1-800-678-1605.

Please review the complete Product Information for BOTOX® Cosmetic, including the Boxed Warning and Medication Guide.