Generic name: onabotulinumtoxinA [ ON-a-BOT-ue-LYE-num-TOX-in-A ]
Brand names: Botox, Botox Cosmetic
Dosage form: injection
Drug class: Skeletal muscle relaxants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Oct 30, 2024.

What is Botox?

Botox injection is a prescription medicine that helps improve the appearance of facial wrinkles and treats some medical conditions by causing muscles to relax, as botox blocks nerve signals to the muscles. Botox contains onabotulinumtoxinA, one of the botulinum toxins from the class of medicines called neurotoxins, which temporarily paralyzes muscles.

Botox Cosmetic and Botox injections are both FDA-approved medicines. Botox Cosmetic is used to soften facial wrinkles and lines, and Botox injections are used to treat medical conditions like chronic migraines, specific bladder issues, excessive sweating, and other muscle-related medical conditions. Botox has a temporary effect and wears off over time.

The difference between Botox and Botox Cosmetic is they are different strengths once the vial has been made up, and they have different FDA-approved uses. Therefore they should not be used interchangeably.

Other botulinum toxins FDA approved medicines are abobotulinumtoxina (Dysport),  incobotulinumtoxina (Xeomin), daxibotulinumtoxinA-lanm (Daxxify), prabotulinumtoxina (Jeuveau) and rimabotulinumtoxinb (Myobloc).

What are Botox Cosmetic and Botox used for?

Botox Cosmetic is used for:

• Facial wrinkles. Botox Cosmetic is used (FDA approved) to help smooth facial wrinkles, specifically moderate to severe forehead lines, crow’s feet lines (wrinkles near the outer corner of the eye), frown lines between the eyebrows, and vertical bands connecting the jaw and neck (platysma bands) in adults.

Botox is used for:

• Chronic Migraine. Botox is used to prevent chronic migraines in adult patients who have 15 or more headaches a month that last for 4 hours a day or longer. For migraines, botox can be injected into seven specific areas of the head and neck muscles. Results usually last up to 12 weeks, depending on the individual patient. Botox has not been established as safe or effective for the prevention of episodic migraine (14 headache days or fewer per month) in seven placebo-controlled studies.
• Cervical dystonia. Botox is used in patients 16 years and older to treat cervical dystonia, which is a condition that causes your neck muscles to contract abnormally. This makes your neck twist and causes your head to tilt to one side, forward, or backward.
• Muscle stiffness: Botox is also used to treat muscle stiffness (spasticity) of the arms, hands, legs, and feet in adults and children who are at least 2 years old. Spasticity is when there is an abnormal increase in muscle tone or stiffness of muscle, which can cause problems with movement and speech, or can cause discomfort or pain.
• Eye muscle conditions. Botox is used to treat specific 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 (benign essential blepharospasm), and a condition in which the eyes do not point in the same direction (strabismus).
• Bladder issues. Botox is used in adults to treat overactive bladder and urinary 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 the neurologic condition neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older. Botox is only used for bladder issues when patients have an inadequate response or are intolerant to an anticholinergic medication.
• Excessive sweating. Botox is also used to treat severe underarm sweating (primary axillary hyperhidrosis) in adults.

Warnings

You should not use Botox if you have an infection in the area where the medicine will be injected. This medicine should not be used to treat overactive bladder or incontinence if you have a current bladder infection or if you are unable to urinate (unless you routinely use a catheter).

The botulinum toxin contained in Botox can spread to other body areas beyond where it was injected. This can cause serious life-threatening side effects.

Call your doctor at once if you have a hoarse voice, drooping eyelids, vision problems, severe eye irritation, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing.

Before taking this medicine

You should not be treated with this medicine if you are allergic to botulinum toxin or other ingredients contained in Botox or Botox Cosmetic, or if you have:

• an infection in the area where the medicine will be injected; or
• or when used 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.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• other types botulinum toxin injections such as Dysport, Jeuveau,  Myobloc, Daxxify  or Xeomin (especially in the last 4 months);
• have amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");
• myasthenia gravis;
• Lambert-Eaton syndrome;
• have had a side effect after prior use of botulinum toxin;
• have a breathing disorder including asthma or emphysema;
• issues 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 any possible risks.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How is Botox given?

Botox injections should be given only by a trained medical professional, which includes when used for cosmetic purposes.

This medicine is injected into a muscle by a healthcare provider. How often you have Botox injections depends on the condition being treated, Botox Cosmetic injections for temporary improvement in the appearance of facial lines should be spaced at least 3 months apart, and for treatment for other conditions, it may be up to at least 12 weeks between injections.

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

You should not seek to have botulinum toxin injections from more than one medical professional at a time. If you do switch healthcare providers, it is important 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.

Cosmetic use. Botox Cosmetic starts working or showing its effect usually in the first 1 to 4 days, with the maximum effect being reached in the first 1 to 4 weeks. The cosmetic effect usually lasts for 3 to 4 months but varies depending on each different individual.

Chronic migraine prevention. Injections should be given in 7 specific head/neck muscle sites, with the recommended re-treatment schedule every 12 weeks.

Eye conditions. When receiving injections for eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. It is important to follow your doctor's instructions. For eye muscle spasms it may take only 1 to 3 days after injection before spasm symptoms begin to improve. You may notice the greatest improvement after 2 to 6 weeks.

Excessive sweating. If you are being treated for excessive underarm sweating, you should shave your underarms about 24 hours before your injection. You should not apply antiperspirant or deodorant for 24 hours before or after you receive the injection. Avoid exercise and hot foods or beverages within 30 minutes before the injection.

Neck muscle spasm. It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to improve. You may notice the greatest improvement after 6 weeks.

Adult bladder dysfunction. Before treatment, your doctor may prescribe antibiotics for you to take for 1-3 days before your treatment, on the day of your treatment, and for 1 to 3 days after your treatment.

For more detailed instructions (with pictures) about dilution, resulting strengths, how to use and where to inject Botox Cosmetic or Botox, read the "Dosage and Administration" on the Professional Botox Cosmetic document  or Professional Botox document

Related/similar drugs

Qulipta, Aimovig, Emgality, Gemtesa, Vyepti, propranolol, baclofen, topiramate, estradiol, oxybutynin

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may not appear right away, but can include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Botox?

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.

Botox side effects

Get emergency medical help if you have signs of an allergic reaction to Botox: hives, itching; wheezing, difficulty 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, and problems with vision.

Common Botox 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, and sore throat;
• trouble swallowing;
• fever, chills, body aches, and 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.

What other drugs will affect Botox?

Tell your doctor about all your other medicines, especially:

• a muscle relaxer;
• cold or allergy medicine;
• sleep medicine;
• an injectable antibiotic;
• a blood thinner - warfarin, Coumadin, Jantoven; or
• medicine used to prevent blood clots - alteplase, clopidogrel, dipyridamole, ticlopidine, and others.

This list is not complete. Other drugs may affect Botox, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

What are the ingredients in Botox and Botox Cosmetic?

Active ingredient: onabotulinumtoxinA

Inactive ingredients: human albumin and sodium chloride

Storage

Unopened vials:

Botox Cosmetic. Store in a refrigerator between 2° to 8°C (36º to 46ºF). Do not use after the expiration date on the vial.

Botox. Store in a refrigerator between 2° to 8°C (36º to 46ºF) for up to 36 months. Do not use after the expiration date on the vial.  

Reconstituted vials:

Reconstituted Botox Cosmetic and Botox: Store in a refrigerator between 2° to 8°C (36º to 46ºF) and administered within 24 hours.

Botox Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Botox.

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Further information

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