Botox Cosmetic

Botox Cosmetic is a prescription injection used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines), crow's feet (lateral canthal lines), forehead lines, and neck bands (platysma bands). It is injected into specific muscles of the face or neck by a healthcare provider trained in the procedure.

This page covers the cosmetic use of onabotulinumtoxinA. See Botox for an overview of both the cosmetic and medical uses of onabotulinumtoxinA.

Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent. It temporarily blocks the nerve signals that tell the treated muscles to contract, which softens the lines those muscles create. OnabotulinumtoxinA received its initial U.S. approval in 1989 for medical use. Botox Cosmetic is the same active ingredient in the same formulation, approved separately for cosmetic indications, most recently expanded to include platysma bands in 2024.

Botox Cosmetic is supplied as a vacuum-dried powder in 50 Unit and 100 Unit single-dose vials, which the provider reconstitutes with sterile saline before injecting. Treatment is not given more often than every 3 months.

Botox Cosmetic is FDA-approved in adults for the temporary improvement in the appearance of moderate to severe:

• Glabellar lines (frown lines) associated with corrugator and/or procerus muscle activity
• Lateral canthal lines (crow's feet) associated with orbicularis oculi activity
• Forehead lines associated with frontalis muscle activity
• Platysma bands (neck bands) associated with platysma muscle activity

These areas may be treated in the same session. Botox Cosmetic is approved for adults only. Safety and effectiveness in anyone under 18 have not been established.

Uses that are not FDA-approved

Botox is also widely used for lip lines, a lip flip, bunny lines on the nose, a gummy smile, jawline slimming (masseter Botox), and shoulder or trapezius injections. None of these are FDA-approved cosmetic uses.

Serious reactions including excessive muscle weakness, difficulty swallowing, and aspiration pneumonia, some with fatal outcomes, have been reported in people who received botulinum toxin injections for uses that are not FDA-approved. In some of these cases the reaction was not due to distant spread of the toxin, but to the effect of the injection on the site itself or the structures next to it. There is not enough information to identify who is at increased risk. The safety and effectiveness of Botox Cosmetic for unapproved uses have not been established.

• Botox Cosmetic is a prescription medicine given by a healthcare provider. The person injecting needs to understand the relevant muscle and structural anatomy of the area, and any changes to that anatomy from previous surgery.
• Small amounts are injected into the muscles of the face or neck.
• Your provider may adjust your dose between sessions to find what works best for you.
• Treatment is not given more often than every 3 months. Treating more frequently than this has not been studied.

For neck band injections, the label sets specific precautions. Injections are given superficially, with the needle perpendicular to the skin. Each band is identified while you contract the platysma, and the band is pinched to separate it from nearby structures. Injections are given at least 1 cm below the lower edge of the jawbone, and are not placed deeper than the platysma muscle, particularly at the front of the neck.

Botox Cosmetic may cause loss of strength, general muscle weakness, vision problems, or dizziness within hours to weeks of an injection. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive Botox Cosmetic if you:

• Are allergic to onabotulinumtoxinA or to any of the other ingredients in the injection
• 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 healthcare provider about all your medical conditions, including if you:

• Have a disease that affects your muscles and nerves, such as ALS (Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome
• Have allergies to any botulinum toxin product, or had any side effect from one 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, or take medicines that thin the blood
• Have plans to have surgery, or have had surgery on your face
• Have weakness of your forehead muscles, such as trouble raising your eyebrows
• Have drooping eyelids, significant dry eye, inflammation at the injection site, or any other change in the way your face normally looks
• Have a history of seizures
• Have or have had heart problems, such as cardiovascular disease
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Pregnancy

There are no adequate data on the use of Botox Cosmetic in pregnant women. In animal studies, onabotulinumtoxinA given during pregnancy reduced fetal weight and fetal skeletal bone formation at clinically relevant doses. Those doses were also associated with toxic effects in the mother, including miscarriage, early delivery, and maternal death.

Breastfeeding

There are no data on whether onabotulinumtoxinA passes into human or animal milk, on effects on the breastfed infant, or on milk production. The benefits of breastfeeding should be weighed against the need for treatment and any potential effect on the infant.

Side effects generally occur within the first week after injection. They are often temporary, but can last several months or longer. Pain, infection, inflammation, tenderness, swelling, redness, bleeding, or bruising may occur where the injection is given. Needle-related pain or anxiety can cause fainting or a drop in blood pressure.

Weakness of the injected muscle is the expected effect of botulinum toxin. Weakness of nearby muscles can also happen if the toxin spreads.

Common side effects by treatment area

The safety of Botox Cosmetic for neck bands was studied in 407 people across two placebo-controlled trials. The side effect profile was consistent with that seen for the other cosmetic uses. No additional side effects were reported when forehead lines, frown lines, and crow's feet were all treated in the same session.

Botox and Botox Cosmetic contain the same active ingredient in the same formulation, so side effects seen with Botox for medical conditions can also occur with Botox Cosmetic. The Medication Guide for both products additionally lists dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, eye problems (double vision, blurred vision, decreased eyesight, drooping eyelids, eyelid swelling, dry eyes), drooping eyebrows, allergic reactions, and upper respiratory tract infection.

Serious side effects and warnings

Boxed warning: spread of toxin effect

Botox Cosmetic carries a Boxed Warning, the FDA's strongest warning. The effects of all botulinum toxin products may spread from the injection area and produce symptoms of botulism. These have been reported hours to weeks after injection and may include:

• 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

Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk is probably greatest in children treated for spasticity, but symptoms can also occur in adults. Cases have been reported at doses comparable to, or lower than, the doses used to treat cervical dystonia and spasticity. Get medical help right away if any of these symptoms occur.

Problems swallowing, speaking, or breathing

These can happen hours, days, or weeks after an injection, usually because the muscles used to breathe and swallow become weak. Swallowing problems may last several months and may require a feeding tube. If swallowing problems are severe, food or liquid may go into the lungs. People who already have swallowing or breathing problems have the highest risk. People with certain breathing problems rely on neck muscles to help them breathe and may be at greater risk of serious breathing problems.

Allergic reactions

Serious and immediate allergic reactions have been reported, including anaphylaxis, serum sickness, hives, soft tissue swelling, and shortness of breath. Get medical help right away if you develop itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint.

Heart problems

There have been reports of cardiovascular events after botulinum toxin injection, including irregular heart rhythm and heart attack, some with fatal outcomes. Some of these people had existing risk factors including cardiovascular disease. Botox Cosmetic should be used with caution in people with pre-existing cardiovascular disease.

Existing nerve and muscle conditions

People with conditions such as amyotrophic lateral sclerosis (ALS), myasthenia gravis, Lambert-Eaton syndrome, or peripheral motor neuropathy may be at increased risk of serious effects including generalized muscle weakness, double vision, drooping eyelids, voice and speech changes, severe swallowing difficulty, and breathing problems.

Dry eye

Dry eye has been reported with Botox Cosmetic injected in or near the orbicularis oculi, the muscle that circles the eye and is targeted when treating crow's feet. If symptoms such as eye irritation, sensitivity to light, or changes in vision persist, you should be referred to an ophthalmologist.

Existing conditions at the injection site

Caution is needed if there is inflammation at the planned injection site, if the eyelid already droops, or if the target muscle is already excessively weak or wasted.

Human albumin

Botox Cosmetic contains albumin, a product derived from human blood. Based on donor screening and the manufacturing process, it carries a remote risk of transmitting viral diseases and variant Creutzfeldt-Jakob disease, and a theoretical and equally remote risk of Creutzfeldt-Jakob disease. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or for albumin contained in other licensed products.

Side effects reported after approval

The following have been reported since Botox and Botox Cosmetic came onto the market. Because they are reported voluntarily, it is not always possible to estimate how often they happen or to confirm they were caused by the product.

• Muscles: localized muscle twitching or involuntary contraction, muscle wasting, muscle aches, and Mephisto sign (an upward arching of the outer eyebrow, sometimes called Spock brow)
• Skin and hair: hair loss, including loss of the eyebrows and eyelashes (madarosis), excessive sweating, itching, and skin rash, including erythema multiforme and psoriasis-like eruptions
• Eyes: double vision, dry eye, eyelid swelling, incomplete eyelid closure (lagophthalmos), misaligned eyes, blurred vision, and other visual disturbances
• Nerves: facial palsy, slurred speech, reduced sensation, localized numbness, pins and needles, peripheral neuropathy, brachial plexopathy, radiculopathy, myasthenia gravis, and fainting
• Ears: hearing loss, ringing in the ears, and vertigo
• Digestive: abdominal pain, diarrhea, dry mouth, nausea, and vomiting
• Breathing: shortness of breath, aspiration pneumonia, and respiratory depression or failure
• General: loss of appetite, malaise, and fever
• New or recurrent seizures, typically in people already predisposed to them
• Cardiovascular events, including irregular heart rhythm and heart attack, some fatal
• Deaths, sometimes associated with swallowing difficulty, pneumonia, other significant debility, or anaphylaxis

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. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Botox Cosmetic blocks the signal between nerve and muscle. It binds to acceptor sites on motor nerve endings, enters the nerve ending, and stops the release of acetylcholine, the chemical messenger that tells a muscle to contract. It does this by cleaving SNAP-25, a protein the nerve needs in order to release acetylcholine from its storage vesicles.

Injected into muscle at the doses used cosmetically, this produces partial, temporary chemical denervation, so the treated muscle contracts less. The lines caused by that muscle repeatedly contracting soften as a result.

The effect reverses over time. The muscle may shrink slightly, nerve fibers sprout new branches, and new acetylcholine receptors form outside the original junction. There is evidence that the nerve supply to the muscle is re-established, slowly undoing the effect.

Botox Cosmetic is classified as an acetylcholine release inhibitor and a neuromuscular blocking agent. On Drugs.com it is listed under skeletal muscle relaxants.

Botox Cosmetic is a protein, so the body can form antibodies against it. If those antibodies are neutralizing, they can inactivate the toxin and make treatment less effective.

Across three crow's feet trials, 916 people treated with Botox Cosmetic had samples tested. Fourteen (1.5%) developed binding antibodies, and none developed neutralizing antibodies.

The factors that drive neutralizing antibody formation are not well understood, but results from some studies suggest that injections given more frequently or at higher doses may increase the risk. The chance may be reduced by using the lowest effective dose at the longest practical intervals.

Cosmetic use of Botox is not covered by insurance. Clinics generally charge either per Unit or per treatment area, so the cost of a session depends on how many areas are treated and how many Units each area needs. Using the approved doses as a guide, frown lines take 20 Units, crow's feet 24 Units, forehead lines with frown lines 40 Units, and neck bands 26 to 36 Units.

Dose by treatment area

When frown lines, crow's feet, and forehead lines are all treated in the same session, the combined dose is 64 Units.

Why forehead lines are always treated together with frown lines

The approved dose for forehead lines is never the forehead alone. It is 20 Units in the forehead plus 20 Units in the frown lines, for a total of 40 Units. The frontalis muscle across the forehead is the muscle that lifts the eyebrows, so relaxing it on its own, without also relaxing the muscles that pull the brow down, can leave the brow sitting lower. Brow drooping was reported in 2% of people treated for forehead lines in the clinical trials.

About Botox Units

Botox Cosmetic doses are measured in Units, but a Unit is specific to this product and the assay used to measure it. Units of Botox Cosmetic cannot be compared with, or converted into, Units of any other botulinum toxin product, including Dysport, Xeomin, Jeuveau, Daxxify, Letybo, or Myobloc. A dose in Units from one product tells you nothing about the equivalent dose of another.

In the two frown line studies, people were assessed at set points after a single 20 Unit treatment. The table below shows the proportion whose frown lines were rated none or mild at maximum frown by the investigator, and the proportion who rated their own lines as at least moderately improved.

Three things follow from this data:

• The effect is already substantial by day 7, with about three-quarters of people rated as responders.
• It peaks at around day 30, not at 2 weeks.
• It then fades gradually rather than stopping. Roughly half of people are still responders at 3 months, and around a quarter at 4 months. For neck bands, the trials measured the main result at day 14.

The effect is temporary because the muscle does not stay blocked. After treatment, the muscle may shrink slightly, nerve endings sprout new branches, and new acetylcholine receptors develop outside the original junction. There is evidence that the nerve supply to the muscle is re-established, slowly reversing the effect.

How satisfied were people with the results?

• Forehead and frown lines together, at day 60: 57% and 35% of people across two studies said they were very satisfied, and a further 33% and 47% mostly satisfied. On placebo, 56% and 54% were very dissatisfied.
• Neck bands, at day 14: 31% and 22% of people across two studies said they were very satisfied, and a further 34% and 40% satisfied. On placebo, 24% and 27% were very dissatisfied.

Does age or sex make a difference?

In the frown line studies, responder rates at day 30 were lower in people aged 65 and over. On the investigator assessment, 83% of people under 65 were responders compared with 39% of those 65 and over. On the person's own assessment, the figures were 91% and 70%. Only 32 people aged 65 or over took part, so these numbers come from a small group.

An exploratory analysis also suggested higher responder rates in women than in men at day 30: 85% of 334 women compared with 59% of 71 men on the investigator assessment.

No formal drug interaction studies have been done with Botox Cosmetic. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start any new medicine until you have told your doctor you have received Botox Cosmetic. Tell your doctor especially if you:

• Have received any other botulinum toxin product in the last four months. The effect of giving different botulinum toxin products at the same time, or within several months of each other, is unknown. Excessive muscle weakness may be worsened if another botulinum toxin is given before the effects of a previous one have worn off. Be sure your doctor knows exactly which product you received.
• Have recently received an antibiotic by injection. Aminoglycoside antibiotics and other medicines that interfere with nerve-to-muscle signaling, such as curare-like compounds, can strengthen the effect of the toxin.
• Take muscle relaxants. These can exaggerate muscle weakness when given before or after Botox Cosmetic.
• Take anticholinergic medicines. Using these after Botox Cosmetic may increase anticholinergic effects such as dry mouth, constipation, and blurred vision. Many allergy, cold, sleep, and bladder medicines are anticholinergic.
• Take antiplatelet medicines (aspirin-like products) or anticoagulants (blood thinners). These increase the risk of bruising and bleeding at the injection site.

Ask your doctor if you are not sure whether your medicine is listed above. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Signs of an overdose are not likely to appear straight away. If accidental injection or swallowing occurs, or an overdose is suspected, the person should be medically supervised for several weeks for signs of muscle weakness, which may be local or distant from the injection site. This may require hospitalization. If the muscles of the throat and gullet are affected, food or liquid may enter the lungs. If the breathing muscles are weakened enough, a breathing tube and assisted ventilation may be needed.

An antitoxin is available from the Centers for Disease Control and Prevention, but it will not reverse effects that are already present.

• Unopened vials of Botox Cosmetic are stored in a refrigerator at 2°C to 8°C (36°F to 46°F).
• Once reconstituted with saline, Botox Cosmetic is stored in a refrigerator at 2°C to 8°C and must be given within 24 hours.
• Vials are single-dose. Any unused portion is discarded.
• Do not use after the expiration date on the vial.

Botox Cosmetic is stored and prepared by the clinic, not by the patient.

Active ingredient: onabotulinumtoxinA, a purified botulinum toxin type A.

Inactive ingredients: human albumin and sodium chloride.

• 50 Unit vial: 50 Units of neurotoxin complex, 0.25 mg human albumin, 0.45 mg sodium chloride
• 100 Unit vial: 100 Units of neurotoxin complex, 0.5 mg human albumin, 0.9 mg sodium chloride

Supplied as a sterile, preservative-free, vacuum-dried powder in a single-dose vial for reconstitution. Every Botox Cosmetic vial label and carton carries U.S. License number 1889, and cartons have tamper-evident features. Products without these features should not be used.

Botox Cosmetic is manufactured by AbbVie Inc., 1 N Waukegan Road, North Chicago, IL 60064.