Generic Name: OnabotulinumtoxinA Injection (ON a BOT ue LYE num TOX in AY)
Brand Name: Botox
- Very bad side effects have happened when onabotulinumtoxinA injection has spread from where it is being used. These signs can happen within hours up to weeks after the shot. Swallowing and breathing problems can cause death. The risk is greatest in children with current muscle problems. Call your doctor right away if you have blurred eyesight, change in voice, drooping eyelids, or loss of strength or weakness all over the body. Call your doctor right away if you are not able to control your bladder, are seeing double, or have trouble breathing, speaking, or swallowing.
Uses of OnabotulinumtoxinA Injection:
- It is used to lower underarm sweating.
- It is used to prevent migraine headaches.
- It is used to treat muscle problems around the eye.
- It is used to treat muscle problems that lead to spasms.
- It is used to treat spasms of the neck.
- It is used to treat an overactive bladder.
- It is used to treat bladder spasms.
What do I need to tell my doctor BEFORE I take OnabotulinumtoxinA Injection?
- If you have an allergy to onabotulinumtoxinA, albumin, or any other part of this medicine.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have an infection where the shot will be given.
- If you have a bladder infection or are not able to pass urine and you are using onabotulinumtoxinA injection for loss of bladder control.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take onabotulinumtoxinA injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take OnabotulinumtoxinA Injection?
- Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
- Talk with your doctor if you have had a botulinum toxin product in the last 3 or 4 months.
- Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how onabotulinumtoxinA injection affects you.
- Do not switch between different forms of this medicine without first talking with the doctor.
- When onabotulinumtoxinA injection has been used for reasons it has not been approved for, very bad side effects like feeling very weak and trouble swallowing have happened. Sometimes, these very bad side effects have been deadly. Most of the time, people already had trouble swallowing or other health problems. Talk with the doctor.
- This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
How is this medicine (OnabotulinumtoxinA Injection) best taken?
Use onabotulinumtoxinA injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- This medicine will be given to you by a doctor.
- It is given as a shot into the muscle(s) causing the spasms.
- It may be given as a shot into the skin near the parts where there is sweating.
What do I do if I miss a dose?
- Call the doctor for an office visit.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
For all uses of this medicine:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Trouble swallowing or speaking.
- Very bad muscle pain or weakness.
- Change in eyesight, eye pain, or very bad eye irritation.
- Seeing double.
- Eyelid droop.
- Drooping eyebrows.
- Dizziness or passing out.
For loss of bladder control:
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- Trouble passing urine.
What are some other side effects of OnabotulinumtoxinA Injection?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where the shot is given.
- Neck pain.
- Less blinking.
- Dry eyes.
- Dry mouth.
- Flu-like signs.
- Back pain.
- Runny nose.
- Feeling tired or weak.
- Mild fever.
- Upset stomach.
- Feeling sleepy.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out OnabotulinumtoxinA Injection?
- If you need to store onabotulinumtoxinA injection at home, talk with your doctor, nurse, or pharmacist about how to store it.
Consumer Information Use and Disclaimer
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else's drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about onabotulinumtoxinA injection, please talk with the doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about onabotulinumtoxinA injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using onabotulinumtoxinA injection.
Review Date: December 6, 2017
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