Botox

Botox and Botox Cosmetic have a black box warning (also called a boxed warning), which is the Food and Drug Administration’s (FDA’s) most serious warning for drugs. These warnings alert doctors and patients that a drug has serious or life-threatening risks.

• Spread of toxin effects warning: Botox and Botox Cosmetic injections can spread outside of the area of injection and produce symptoms consistent with botulinum toxin effects, such as muscle weakness, loss of bladder control, trouble with vision, difficulty speaking, trouble breathing, and difficulty swallowing. Symptoms can happen hours to weeks after injection.  

Users of Botox and Botox Cosmetic should be aware of these additional safety warnings:

• Switching Botulinum toxin products warning: Units of other botulinum toxin products are not interchangeable and should not be used in place of Botox or Botox Cosmetic.
• Serious side effects with unapproved use warning: Botox and Botox Cosmetic should not be used for any unapproved uses. Using Botox for unapproved uses can lead to serious reactions, such as difficulty swallowing, extreme weakness, pneumonia, and death.
• Serious allergic reaction warning: Botox and Botox Cosmetic injections may cause serious allergic reactions. Symptoms can include swelling of the face, lips, tongue or throat, trouble with swallowing or breathing, red itchy welts, fever, rash, or painful swollen joints. If you experience any of these side effects, seek emergency care (call 911) and do not continue further injections of Botox and Botox Cosmetic.
• Nerve and muscle disorder warning: Botox and Botox Cosmetic may put you at an increased risk of symptoms including muscle weakness, double vision, drooping eyelid, difficulty speaking, difficulty breathing, and breathing issues if you have an existing neurologic or neuromuscular disorder (for example, myasthenia gravis or Lambert-Eaton syndrome).
• Breathing difficulties warning: Treatment with Botox can cause difficulty swallowing or breathing due to possible involvement of muscles that control swallowing or breathing. Patients treated with Botox may require immediate medical attention should they develop problems with swallowing, speech, or any breathing disorders. Your doctor will need to monitor you closely if you have an existing breathing, swallowing or lung condition, especially if you are being treated for muscle spasticity or loss of bladder control due to a nervous system disorder.
• Bronchitis and upper respiratory tract infection warning: Bronchitis and upper respiratory tract infections were reported more frequently when Botox was used to treat muscle spasticity.
• Eye problems warning: Botox and Botox Cosmetic can cause reduced blinking when used to treat eye twitching, which can lead to eye exposure and eye trauma. Botox Cosmetic can cause eye irritation, double vision, and vision changes when used for cosmetic purposes.
• Bleeding behind the eye warning: During the administration of Botox for the treatment of eye muscle problems, eye bleeding has occurred.
• Heart problems warning: Botox or Botox Cosmetic may cause abnormal heart rhythms or a heart attack. If you have an existing heart condition, your doctor will decide if Botox is appropriate for you.
• Urinary tract infection warning: Botox can increase the risk of urinary tract infections when used to treat overactive bladder. If you have a history of urinary tract infections, let your doctor know before starting treatment with Botox.
• Trouble emptying bladder warning: Botox is not recommended for loss of bladder control if you are not able to fully empty your bladder or are not willing to receive a catheter to help empty your bladder after a procedure. Talk with your doctor if you have issues emptying your bladder.

Talk with your doctor about these warnings in the context of your individual treatment plan and medical history.

Botox is used to treat:

• Overactive bladder symptoms in adults when another type of medicine (anticholinergic) does not work well enough or cannot be taken
• Leakage of urine in adults with overactive bladder due to nervous system disorder when an anticholinergic does not work well enough or cannot be taken
• Overactive bladder due to a nervous system disorder in children 5 years of age and older when an anticholinergic does not work well enough or cannot be taken
• Headaches in adults with frequent migraines (Botox helps prevent migraine headaches)
• Muscle stiffness in people 2 years of age and older who have spasticity
• Neck pain and abnormal head position that occurs in adults with cervical dystonia
• Eye muscle problems in people 12 years of age and older
• Abnormal spasms of the eyelids in people 12 years of age and older
• Severe underarm sweating in adults when other medicines applied to the skin do not work well enough

Botox Cosmetic is used to improve the look of:

• Moderate to severe wrinkles between the eyebrows
• Moderate to severe wrinkles near the outer corner of the eye
• Moderate to severe forehead lines

Doctors sometimes prescribe medications for different uses. Ask your doctor or pharmacist for information about other uses of this medication.

Botox and Botox Cosmetic are prescription drugs that belong to a class of medications called neuromuscular blockers. Botox and Botox Cosmetic work by blocking the release of a chemical found in the body called acetylcholine, which helps muscles function. Botox blocks signals from the nerves to the muscles in small areas where injected, preventing muscles from being active. 

When used for excessive underarm sweating, Botox works to temporarily inactivate sweat glands where it is injected in the skin.

Botox and Botox Cosmetic are available as a vial that a healthcare provider uses to prepare for injection into the muscle, skin, or into the wall of the bladder. Botox and Botox Cosmetic are currently not available as a generic medication. They are available as brand-name drugs only.

Dysport (abobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Myobloc (rimabotulinumtoxinB) and Xeomin (incobotulinumtoxinA) are other injectable botulinum toxin products that are used to treat different conditions than Botox and Botox Cosmetic.

Botox side effects are possible and may go away with continued use. Serious side effects are rare

The more common side effects that occur with Botox and Botox Cosmetic include:

• Drooping of eyelids or eyebrows
• Dry eyes
• Dry mouth
• Headache
• Infection in the upper respiratory tract region (areas of the nose, mouth and throat)
• Neck pain
• Pain, swelling or discomfort at the site of injection
• Pain while urinating in people treated for loss of bladder control
• Tiredness
• Urinary tract infection in people treated for loss of bladder control  
• Vision problems that can include reduced or blurry vision

Call your doctor right away if you have serious side effects. Seek emergency care (call 911) if you experience life-threatening symptoms, such as difficulty breathing; chest pain; loss of consciousness; sudden vision changes; or swelling of the face, mouth, tongue or throat.

Serious side effects and their symptoms can include the following:

• Trouble breathing, speaking or swallowing. Symptoms can include:
  
  • Abnormal voice
  • Difficulty speaking
  • Difficulty swallowing
  • Pain when swallowing
  • Shortness of breath

• Serious allergic reactions. Symptoms can include:
  
  • Fever
  • Painful swollen joints
  • Rash
  • Red, itchy welts
  • Shortness of breath or wheezing
  • Swelling of joints

• Spread of toxin effects. Symptoms can include:
  
  • Abnormal voice
  • Blurred vision
  • Difficulty speaking
  • Double vision
  • Drooping eyelids
  • Loss of bladder control
  • Muscle weakness
  • Trouble breathing
  • Trouble swallowing

Other side effects are possible. Talk with your doctor or pharmacist if you have any side effect that bothers you or that does not go away.

Without insurance, Botox and Botox Cosmetic are typically high-cost drugs (defined as costing more than $100/month). You can check the out-of-pocket cash pay price for Botox and Botox Cosmetic on prescription drug discount websites.

With insurance, prices can vary considerably. Individual health plans may have preferred drugs with better pricing. If the price of Botox or Botox Cosmetic on your health plan is too expensive, ask your doctor or pharmacist if there is an equivalent drug you can substitute.  

Botox and Botox Cosmetic may interact with other prescription and over-the-counter medications, vitamins, or herbal supplements you may be taking. To help avoid harmful interactions, your doctor should manage all your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbal supplements you are taking. To find out how this drug might interact with something else you are taking, talk with your doctor or pharmacist.

This is not a complete list of drugs that may interact with Botox. However, examples of drugs that may interact with Botox include:

Use of Botox and Botox Cosmetic with certain medications used to treat infections can increase the effects of Botox. Examples of such medications include:

• Amikacin
• Clindamycin (Cleocin)
• Colistimethate (Coly-Mycin)
• Gentamicin
• Kanamycin
• Lincomycin (Lincocin)
• Neomycin
• Polymyxin
• Streptomycin
• Tobramycin

Use of other drugs that contain botulinum toxin in combination with Botox or Botox Cosmetic may cause excessive weakness. Examples of these medications include:

• Dysport (abobutlinumtoxinA)
• Jeuveau (prabotulinumtoxinA-xvfs)
• Myobloc (rimabotulinumtoxinB)
• Xeomin (incobotulinumtoxinA)

Use of medications that target the same chemical (acetylcholine) in the body as Botox and Botox Cosmetic while receiving treatment with Botox may increase possible side effects, such as dry mouth, dry eyes, constipation, blurry vision, drowsiness, and difficulty urinating. Examples of these medications include:

• Atropine (Atropen)
• Benztropine (Cogentin)
• Dicyclomine (Bentyl)
• Diphenhydramine (Benadryl)
• Glycopyrrolate (Robinul)
• Hyoscyamine (Levsinex)
• Oxybutynin (Ditropan XL)
• Scopolamine (Transderm Scop)
• Solifenacin (Vesicare)
• Tolterodine (Detrol)

Muscle weakness may be increased when a muscle relaxant is used before or after administration of Botox.  Examples of muscle relaxants include:

• Baclofen (Gablofen, Lioresal)
• Carisoprodol (Soma)
• Cyclobenzaprine (Flexeril)
• Metaxalone (Skelaxin)
• Methocarbamol (Robaxin)
• Orphenadrine (Norflex)
• Tizanidine (Zanaflex)

Disclaimer: Since drugs interact differently in each person, this information is not guaranteed to include all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbal supplements, and over-the-counter drugs that you are taking.

This drug comes with several alerts and warnings:

Botox has not been studied and should not be used in:

• Children or adolescents younger than 18 years of age for treatment of overactive bladder
• Children younger than 5 years of age for treatment of overactive bladder due to nervous system disorder
• Children and adolescents younger than 18 years of age for prevention of chronic migraine
• Children younger than 2 years of age for treatment of muscle spasticity
• Children and adolescents younger than 18 years of age for treatment of severe underarm sweating
• Children and adolescents younger than 16 years of age for treatment of neck pain and abnormal head position due to cervical dystonia
• Children younger than 12 years of age for treatment of abnormal spasms of eyelids or eye muscle problems
• Children and adolescents younger than 18 years of age for any cosmetic purposes (Botox Cosmetic)

• In studies of Botox where people were treated for overactive bladder, people 65 years of age and older were at a higher risk of developing urinary tract infections and being unable to empty the bladder completely.
• In clinical trials, Botox Cosmetic was less effective in people 65 years of age and older compared to younger patients.

Call your doctor right away if you have serious side effects. Seek emergency care (call 911) if you experience life-threatening symptoms, such as difficulty breathing; chest pain; loss of consciousness; sudden vision changes; or swelling of the face, mouth, tongue or throat.

It is not known whether use of Botox or Botox Cosmetic during pregnancy will cause harm to your unborn baby. Talk with your healthcare provider if you are pregnant or plan to become pregnant, as you may need to discontinue use of Botox or Botox Cosmetic during pregnancy.

It is unknown if this drug passes into breast milk or if this drug has effects on the breast-fed infant or milk production. Talk with your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

A trained healthcare professional injects this drug into a muscle, into the skin, or into the wall of the bladder. The location of injection is specific to the condition.

Depending on how long the benefits of your previous treatment lasts, you may need additional injections every 3 to 4 months for cosmetic uses, as well as for cervical dystonia, eye muscle problems, abnormal eye spasms, spasticity, loss of bladder control, overactive bladder, and chronic migraine. You may need additional injections every 6 to 7 months or more frequently when your symptoms return if you are being treated for excessive underarm sweating or overactive bladder due to a neurologic condition. Your healthcare provider will determine the length of treatment appropriate for you.

All possible dosages may not be included here. Your dose and how often you receive Botox will depend on:

• Condition being treated
• How you react to the first dose
• Other medical conditions you have
• Severity of your condition

• Single-dose vial for injection:
  
  • 50 Units (Botox Cosmetic only)
  • 100 Units (Botox and Botox Cosmetic)
  • 200 Units (Botox only)

• Adult dose (age ≥ 18 years)
  
  • Recommended dosage: 100 Units of Botox administered into the bladder wall one time per treatment

• Adult dose (age ≥ 18 years)
  
  • Recommended dosage: 200 Units of Botox administered into the bladder wall one time per treatment
• Child or adolescent dose (ages 5 to 17 years)
  
  • Initial and subsequent doses are based upon body weight.

• Adult dose (age ≥ 18 years)
  
  • Recommended dosage: 155 Units of Botox injected across seven specific head and neck muscle areas, totaling 31 site injections (5 Units of Botox per site)
  • Recommended retreatment schedule is every 12 weeks.

• Recommended dosage: individualized based on the size, number and location of muscles involved, severity of spasticity, presence of local muscle weakness, response to previous treatment, and side effect history with Botox
  
  • Adult dose (age ≥ 18 years)
    
    • Upper limb spasticity: doses range from 75 to 400 Units of Botox, divided among selected muscles
    • Lower limb spasticity: recommended dose is 300 to 400 Units divided among five muscles
  • Child or adolescent dose (age ≥ 2 years)
    
    • Initial and subsequent doses are based upon body weight.

• Adolescent and adult dose (age ≥ 16 years)
  
  • Initial and follow-up injection dosages: individualized based on your head and neck position, location of pain, size of the muscle, response to treatment, and side effect history

• Adult dose (age ≥ 18 years)
  
  • Recommended dosage: 50 Units of Botox injected into each underarm
  • Administer repeat injections when the effect of previous injection is no longer seen.

• Adolescent and adult dose (age ≥ 12 years)
  
  • Recommended dosage: 1.25 to 2.5 Units of Botox injected into the upper and lower eyelid

• Adolescent and adult dose (age ≥ 12 years)
  
  • Initial dosing
    
    • 1.25 to 5 Units of Botox is injected into the affected muscle. The specific dose is based on the eye muscles involved and the amount of misalignment in the eye.
  • Subsequent dosing
    
    • Your doctor will reexamine you 7 to 14 days after each injection to determine how effective the injection is.
    • If your first injection is not effective enough, your doctor may increase the dose of future injections.

• Adult dose (age ≥ 18 years)
  
  • Total dose of 20 Units: 4 Units into each of five sites above eyebrows

• Adult dose (age ≥ 18 years)
  
  • Total dose of 24 Units per side: 4 Units into three sites per side (six total injection points) near the outer corner of the eye

• Adult dose (age ≥ 18 years)
  
  • Total dose of 20 Units: 4 Units into five sites across the forehead

Your healthcare provider will inject Botox or Botox Cosmetic into your affected muscles, skin or bladder. If you miss an appointment, call your doctor to reschedule your appointment.

If you are injected with too much Botox, you have a higher risk of having side effects caused by this drug. If you think you have been administered too much of this drug, call your doctor or poison control center (1-800-222-1222). Symptoms of overdose are not likely to be present right after injection. If an overdose is expected, you may need to be medically supervised for multiple weeks for signs and symptoms of muscle weakness.

Seek emergency care (call 911) if you experience life-threatening symptoms, such as difficulty breathing; chest pain; loss of consciousness; sudden vision changes; or swelling of the face, mouth, tongue or throat.

Keep these considerations in mind if your doctor prescribes Botox for you.

• Your doctor or healthcare provider administers Botox injections.
• Your doctor or healthcare provider will tell you how often you will receive treatment.

There are no known interactions with Botox and alcohol. If you are concerned about using Botox while drinking alcohol, talk with your doctor.

Your doctor will talk with you about how often you will receive your Botox or Botox Cosmetic injections.

This medication is only available through a trained healthcare provider. Your healthcare provider can help you determine where and how you will receive your treatments.

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

Botox and Botox Cosmetic are in a class of medications called neuromuscular blocking agents. Uses include treating overactive bladder, neck muscle spasms, muscle spasticity, excessive eye blinking, crossed eyes, excessive armpit sweating, preventing migraines, and minimizing the appearance of wrinkles.

Other similar neuromuscular blocking agents include Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Myobloc (rimabotulinumtoxinB) and Jeuveau (prabotulinumtoxinA-xvfs). Not all the neuromuscular blocking agents are FDA-approved for the same indications as Botox and Botox Cosmetic.

Botulinum toxin products are prepared differently, and they are not interchangeable. Each medication has its own benefits and side effects profile. Your doctor will help determine the best option for you.

Do not stop taking this drug unless instructed by your doctor.

Healthgrades Disclaimer:

This information is for educational purposes only. It should not be interpreted as medical advice, diagnosis or treatment. Healthgrades takes every effort to ensure this information is accurate and up to date. This content is not intended to cover all possible uses, side effects, warnings, precautions, allergic reactions, or drug interactions. Do not assume that the absence of such information means the medication is safe for your personal use. Always consult your doctor, pharmacist, or healthcare professional before taking or discontinuing any medication.