Botox is used in adults to treat cervical dystonia (abnormal head position and neck pain).

Botox is also used to treat muscle spasms and stiffness (spasticity) of the arms, hands, legs, and feet in adults and children at least 2 years old. This medicine will not treat spasticity caused by cerebral palsy.

Botox is also used to treat certain eye muscle conditions caused by nerve disorders in adults and children who are at least 12 years old. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botox is also used in adults to treat overactive bladder and incontinence (urine leakage) that has not been helped by other medication. Botox may be used to treat incontinence caused by nerve disorders such as spinal cord injury or multiple sclerosis.

Botox is also used to treat overactive bladder caused by a neurologic disorder (such as multiple sclerosis or spinal cord injury) in children at least 5 years old when other medicines cannot be used or have not worked.

Botox is also used in adults to prevent chronic migraine headaches that occur more than 15 days per month and last 4 hours or longer. Botox should not be used to treat a common tension headache.

Botox is also used to treat severe underarm sweating (hyperhidrosis) in adults.

Botox Cosmetic is used to temporarily lessen the appearance of facial wrinkles in adults.

Botox may also be used for purposes not listed in this medication guide.

You should not be treated with Botox if you are allergic to botulinum toxin, or if you have:

• an infection in the area where the medicine will be injected; or
• (for overactive bladder and incontinence) if you have a current bladder infection or if you are unable to urinate and you do not routinely use a catheter.

Tell your doctor if you have ever had:

• other botulinum toxin injections such as Dysport, Xeomin, or Myobloc (especially in the last 4 months);
• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• a side effect after prior use of botulinum toxin;
• a breathing disorder such as asthma or emphysema;
• problems with swallowing;
• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);
• a change in the normal appearance of your face;
• bleeding problems; or
• surgery (especially on your face).

Botox is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about your individual risk.

Tell your doctor if you are pregnant or breastfeeding.

Use Botox Cosmetic (Onabotulinumtoxina Botox) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

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

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
• loss of bladder control;
• hoarse voice, trouble talking or swallowing;
• drooping eyelids or eyebrows;
• vision changes, eye pain, severely dry or irritated eyes (your eyes may also be more sensitive to light);
• chest pain or pressure, pain spreading to your jaw or shoulder, irregular heartbeats;
• pain or burning when you urinate, trouble emptying your bladder;
• sore throat, cough, chest tightness, shortness of breath; or
• eyelid swelling, crusting or drainage from your eyes, problems with vision.

Common side effects may include:

• painful or difficult urination;
• headache, neck pain, back pain, pain in your arms or legs;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• trouble swallowing;
• fever, chills, body aches, flu symptoms;
• increased sweating in areas other than the underarms; or
• bruising, bleeding, pain, redness, or swelling where the injection was given.

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.

Botox may impair your vision or depth perception. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid going back to your normal physical activities too quickly after receiving an injection.