- botulinum toxin type a
injection, powder, lyophilized, for solution
BOTOX® Cosmetic (Boe-tox)
Read the Medication Guide that comes with BOTOX or BOTOX Cosmetic before you start using it and each time it is given to you. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You should share this information with your family members and caregivers.
BOTOX and BOTOX Cosmetic may cause serious side effects that can be life threatening, including:
These problems can happen hours, days, to weeks after an injection of BOTOX or BOTOX Cosmetic. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX or BOTOX Cosmetic:
1. Problems swallowing, speaking, or breathing. These problems can happen hours, days, 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.
2. 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:
These symptoms can happen hours, days, to weeks after you receive an injection of BOTOX or BOTOX Cosmetic.
There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat chronic migraine, severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines and/or crow's feet lines.
What are BOTOX and BOTOX Cosmetic?
BOTOX is a prescription medicine that is injected into muscles and used:
BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.
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 crow's feet lines in adults for a short period of time (temporary).
You may receive treatment for frown lines and crow's feet lines at the same time.
It is not known whether BOTOX is safe or effective in people younger than:
BOTOX Cosmetic is not recommended for use in children younger than 18 years of age.
It is not known whether BOTOX and BOTOX Cosmetic are safe or effective to prevent headaches in people with migraine who have 14 or fewer headache days each month (episodic migraine).
It is not known whether BOTOX and BOTOX Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.
Who should not take BOTOX or BOTOX Cosmetic?
Do not take BOTOX or BOTOX Cosmetic if you:
What should I tell my doctor before taking BOTOX or BOTOX Cosmetic?
Tell your doctor about all your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. Using BOTOX or 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 or BOTOX Cosmetic in the past.
Especially tell your doctor if you:
Ask your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take BOTOX or BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may cause loss of strength or general muscle weakness, or vision problems within hours to weeks of taking BOTOX or BOTOX Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"
What are the possible side effects of BOTOX and BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic can cause serious side effects. See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"
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.
General information about BOTOX and BOTOX Cosmetic:
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about BOTOX and BOTOX Cosmetic. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about BOTOX and BOTOX Cosmetic that is written for healthcare professionals.
What are the ingredients in BOTOX and BOTOX Cosmetic?
Active ingredient: botulinum toxin type A
Inactive ingredients: human albumin and sodium chloride
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by: Allergan Pharmaceuticals Ireland
a subsidiary of: Allergan, Inc.
2525 Dupont Dr.
Irvine, CA 92612
© 2013 Allergan, Inc.
® marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Dysport® is a registered trademark of Ipsen Biopharm Limited Company.
Xeomin® is a registered trademark of Merz Pharma GmbH & Co KGaA.