onabotulinumtoxinA may spread from the injection site to other areas of the body causing symptoms of a serious condition called botulism. These symptoms may occur hours to weeks after you receive onabotulinumtoxinA . Symptoms may include loss of strength; muscle weakness; double or blurred vision; drooping eyelids; hoarseness; loss of voice; loss of bladder control; or trouble speaking, breathing, or swallowing. The risk may be greater in children being treated for spasticity (muscle spasms), but these symptoms may also occur in adults. onabotulinumtoxinA is not approved for use in children. Contact your doctor immediately if these symptoms occur.
Severe and sometimes fatal breathing or swallowing problems have been reported. The risk may be greater in patients who already have breathing or swallowing problems. Tell your doctor if you have or are at risk of developing breathing or swallowing problems.
Temporarily improving the appearance of moderate to severe lines between the eyebrows in patients 65 years old or younger. It may also be used for other conditions as determined by your doctor.
onabotulinumtoxinA is a neurotoxin. It works by blocking nerve impulses to the muscles or sweat glands, temporarily paralyzing the muscle or gland.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with onabotulinumtoxinA . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with onabotulinumtoxinA . Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if onabotulinumtoxinA may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use onabotulinumtoxinA as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use onabotulinumtoxinA .
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Anxiety; back pain; dizziness; drowsiness; dry mouth; dry or irritated eyes; facial pain; flu-like symptoms; headache; inability to focus eyes; increased cough; indigestion; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; stiff or weak muscles at or near the injection site; sweating.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bleeding at the injection site; chest pain; difficulty swallowing or breathing; double or blurred vision, or other vision changes; drooping of the upper eyelid; eyelid swelling; fainting; fever, chills, or persistent sore throat; irregular heartbeat; loss of bladder control; loss of strength; paralysis; seizures; severe or persistent muscle weakness or dizziness; shortness or breath; speech changes or problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms of overdose may include paralysis; severe muscle weakness; trouble swallowing; weak or shallow breathing.Proper storage of onabotulinumtoxinA :
onabotulinumtoxinA is usually handled and stored by a health care provider. If you are using onabotulinumtoxinA at home, store onabotulinumtoxinA as directed by your pharmacist or health care provider. Keep onabotulinumtoxinA out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about onabotulinumtoxinA . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.