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Brand Names: Botox, Botox Cosmetic, Dysport

Generic Name: botulinum toxin type A (Pronunciation: BOT ue LYE num TOX in type A)

• What is this drug (Botox)?
• What are the possible side effects of botulinum toxin type A (Botox)?
• What is the most important information I should know about botulinum toxin type A (Botox)?
• What should I discuss with my healthcare provider before I receive botulinum toxin type A (Botox)?
• How is botulinum toxin type A given (Botox)?
• What happens if I miss a dose (Botox)?
• What happens if I overdose (Botox)?
• What should I avoid after receiving botulinum toxin type A (Botox)?
• What other drugs will affect botulinum toxin type A (Botox)?
• Where can I get more information?

What is this drug (Botox)?

Botulinum toxin type A is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botulinum toxin type A is used to treat cervical dystonia (severe spasms in the neck muscles), or severe underarm sweating (hyperhidrosis).

Botulinum toxin type A is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botulinum toxin type A is also used to temporarily lessen the appearance of facial wrinkles.

Botulinum toxin type A may also be used for other purposes not listed in this medication guide.

What are the possible side effects of botulinum toxin type A (Botox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;
• drooping eyelids;
• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• loss of bladder control;
• problems with vision or depth perception;
• crusting or drainage from your eyes;
• severe skin rash or itching; or
• chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

• muscle weakness near where the medicine was injected;
• bruising, bleeding, pain, or tenderness where the injection was given;
• headache, muscle stiffness, neck or back pain;
• fever, cough, sore throat, runny nose, nausea, flu symptoms,
• dizziness, drowsiness, anxiety;
• dry mouth, dry eyes;
• increased sweating in areas other than the underarms;
• itchy or watery eyes, increased sensitivity to light; or
• eyelid swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about botulinum toxin type A (Botox)?

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected. You should not receive the Dysport brand of this medication if you are allergic to cow's milk.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, or heart disease.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.