Botox Cosmetic
Pronunciation: Boe-tox Coz-met-tik
Generic name: onabotulinumtoxinA
Dosage form: single-use vial (50 Units, 100 Units)
Drug class: Skeletal muscle relaxants
What is Botox Cosmetic?
Botox Cosmetic is a prescription treatment for fine lines and wrinkles. It temporarily improves the look of moderate to severe frown (glabellar) lines, crow's feet, forehead lines, and platysma bands (vertical bands that connect the jaw and neck). Small amounts of Botox are given by injection into the facial or neck areas requiring wrinkle reduction by a certified provider.
- This guide covers Botox for anti-aging and aesthetic treatment. See this Botox page for medical uses of Botox (onabotulinumtoxinA).
Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent that works by temporarily blocking nerve signals to specific facial or neck muscles. This:
- Smooths forehead lines and crow's feet
- Reduces frown lines between the eyebrows
- Softens the look of neck bands
- Provides a more refreshed and youthful appearance.
Botox starts working within 24-48 hours and peaks in 2 weeks. Botox Cosmetic wears off within 3 to 4 months as new nerve endings sprout and gradually reconnect with muscles, allowing them to contract again normally and restore movement to the treated area.
Botox Cosmetic first gained FDA approval on December 9, 1991.
Side effects
The most common side effects of Botox Cosmetic are:
- temporary pain or discomfort where the injection was given
- swelling
- mild bruising.
Serious side effects
Botox Cosmetic carries a Boxed Warning for the distant spread of the toxin's effect. Rarely, it may also cause problems breathing or swallowing. These problems can happen hours, days, to weeks after an injection of Botox Cosmetic. Call your doctor or get medical help right away if you have any of these problems after your Botox treatment.
- Spread of toxin effects. In some cases, the effect of botulinum toxin A may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. Seek immediate medical attention if you have:
- loss of strength and muscle weakness all over the body
- double vision, blurred vision, and drooping eyelids
- hoarseness or change or loss of voice (dysphonia)
- trouble saying words clearly (dysarthria)
- loss of bladder control
- trouble breathing
- trouble swallowing.
There has not been a confirmed serious case of the spread of toxin effect away from the injection site when Botox Cosmetic has been used at the recommended dose to treat frown lines, crow’s feet lines, forehead lines, or vertical bands connecting the jaw and neck.
- Problems swallowing, speaking, or breathing. These problems can happen hours, days, to
weeks after an injection of Botox Cosmetic, usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Botox Cosmetic.- People with certain breathing problems may need to use muscles in their neck to help them breathe. These people may be at greater risk for serious breathing problems with Botox Cosmetic.
- Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving Botox Cosmetic have the highest risk of getting these problems.
These problems could make it unsafe for you to drive a car or do other dangerous activities.
Botox may cause the following other serious side effects:
- Allergic reactions. Symptoms of an allergic reaction to Botox Cosmetic may include itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
- Eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
- Drooping eyebrows.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Botox Cosmetic. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA1088.
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FDA approvals and uses
Botox Cosmetic is FDA-approved for:
- Moderate to severe frown lines between the eyebrows (glabellar lines) associated with corrugator and/or procerus muscle activity
- Moderate to severe crow’s feet lines (lateral canthal lines) associated with orbicularis oculi activity
- Moderate to severe forehead lines associated with frontalis muscle activity
- Moderate to severe vertical bands connecting the jaw and neck (platysma bands) associated with platysma muscle activity.
Use of Botox Cosmetic for lip lines, bunny lines, or reshaping the jawline (Masseter Botox) is common, but not an FDA-approved use. It is only approved for adults over the age of 18.
It is not known if Botox Cosmetic is safe and effective for use more than 1 time every 3 months.
Before receiving
Do not receive Botox Cosmetic if you:
- are allergic to any of the ingredients in Botox or Botox Cosmetic
- have had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg).
- have an infection at the planned injection site.
Before receiving Botox Cosmetic, tell your certified provider about all your medical conditions, including if you:
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis, or Lambert-Eaton syndrome).
- have allergies to any botulinum toxin product
- had any side effects from any botulinum toxin product in the past
- have or have had a breathing problem, such as asthma or emphysema
- have or have had swallowing problems
- have or have had bleeding problems
- have plans to have surgery
- had surgery on your face
- have weakness of your forehead muscles, such as trouble raising your eyebrows
- have drooping eyelids or your face looks different from how it usually looks
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
It is not known if Botox Cosmetic can harm your unborn baby.
Breastfeeding
It is not known if Botox Cosmetic passes into breast milk.
How will I receive Botox Cosmetic?
Botox Cosmetic is a prescription medicine given by a certified provider.
- Small amounts are injected into the muscles of the face or neck areas requiring wrinkle reduction.
- Your healthcare provider may change the dose until they find the best dose for you.
- Your healthcare provider will tell you how often you will receive your injections, but it is not more often than every 3 months.
Dosing information
Dose of Botox for frown (glabellar) lines
- 0.1 mL (4 units) into each of 5 sites, for a total dose of 20 Units.
Dose of Botox for crows feet (lateral canthal lines)
- 0.1 mL (4 units) into each of 3 sites per side (6 total injection points), for a total dose of 24 Units.
Dose of Botox for forehead lines
- 0.1 mL (4 units) into each of 5 forehead line sites (20 Units) with 0.1 mL (4 Units) into each of 5 glabellar line sites (20 units), for a recommended total dose of 40 Units.
Dose of Botox for Platysma bands
- 0.05 mL (2 Units) into each of 4 sites in the upper segment of the platysma muscles, below the jawline on each side and 0.025 mL (1 Unit) into 5 sites on each vertical neck band per side (1 to 2 bands per side) for a total of 26 Units, 31 Units, or 36 Units (18. 23, or 28 injection sites, respectively).
What other drugs affect Botox Cosmetic?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Botox Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Botox Cosmetic in the past. Especially tell your doctor if you:
- have received any other botulinum toxin product in the last four months.
- have received injections of botulinum toxin, such as Myobloc (rimabotulinumtoxinB), Dysport (abobotulinumtoxinA), Xeomin (incobotulinumtoxinA), Jeuveau (prabotulinumtoxinA-xvfs), Daxxify (daxibotulinumtoxinA-lanm), or Letybo (letibotulinumtoxinA-wlbg) in the past. This may not be a complete list of all botulinum toxin products. Be sure your doctor knows exactly which product you received.
- have recently received an antibiotic by injection
- take muscle relaxants
- take an allergy or cold medicine
- take a sleep medicine.
- take antiplatelets (aspirin-like products) or anti-coagulants (blood thinners).
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Botox Cosmetic ingredients
Active ingredient: onabotulinumtoxinA
Inactive ingredients: human albumin and sodium chloride.
Available as 50 Units or 100 Units in a vacuum-dried powder in a single-dose vial for reconstitution.
Manufacturer
Botox Cosmetic is made by Allergan Aesthetics, an AbbVie company.
Botox cosmetic 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 Cosmetic.
Botox (onabotulinumtoxinA) - AbbVie Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 units |
Single-Dose Vial | 200 units |
Single-Dose Vial | 50 units Discontinued |
View Botox information in detail.
Botox Cosmetic (onabotulinumtoxinA) - AbbVie Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 100 units |
Single-Dose Vial | 50 units |
Popular FAQ
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.