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 people 18 to 65 years of age for a short period of time (temporary).
BOTOX® and 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 after treatment with BOTOX® or BOTOX® Cosmetic:
Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of BOTOX® or BOTOX® Cosmetic usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX®or BOTOX® Cosmetic
People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with BOTOX® or BOTOX® Cosmetic
Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving BOTOX® or BOTOX®Cosmetic have the highest risk of getting these problems
Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
Once you receive BOTOX® treatment, you’ll start to feel the benefits soon, usually within a few days to a couple of weeks after receiving BOTOX® treatment.
After receiving BOTOX® treatment, relief may last for up to 3 months.
You may be able to receive additional BOTOX® treatment as needed. Your doctor will decide if repeat injections can help you. You may receive repeat injections as long as:
BOTOX® and BOTOX® Cosmetic can cause serious side effects. See "What is the most important information I should know about BOTOX®and BOTOX® Cosmetic" in Medication Guide.
Other side effects of BOTOX® and BOTOX® Cosmetic include:
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of BOTOX® and BOTOX® Cosmetic. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.