The #1 selling product
of its kind in the us1*

*Data collected through February 2016

A HISTORY OF APPROVALS

Over the years, BOTOX® Cosmetic has been approved for more treatment areas than any other
product of its kind–the areas that matter to your patients.2-4 Roll over each year to see more.

Over the years, BOTOX® Cosmetic has been approved for more treatment areas than any other
product of its kind–the areas that matter to your patients.2-4 Tap each year to see more.

Over the years, BOTOX® Cosmetic has been approved for more treatment areas than any other product of its kind–the areas that matter to your patients.2-4
Tap the arrows to see more.

  • 1989

    BOTOX® introduced for therapeutic use.

  • 2002

    First for glabellar lines: The first product of its kind to be approved for moderate to severe glabellar lines2

  • 2012

    BOTOX® Cosmetic celebrates 10 years.

  • 2013

    BOTOX® Cosmetic is the only FDA-approved treatment to temporarily improve the appearance of moderate to severe lateral canthal lines.2

  • 2017

    BOTOX® Cosmetic is the only FDA-approved treatment to temporarily improve the appearance of moderate to severe forehead lines.2

1989

BOTOX® introduced for therapeutic use.

2002

First for glabellar lines: The first product of its kind to be approved for moderate to severe glabellar1

2012

BOTOX® Cosmetic celebrates 10 years.

2013

BOTOX® Cosmetic is the only FDA-approved treatment to temporarily improve the appearance of moderate to severe lateral canthal lines.1

2017

BOTOX® Cosmetic is the only FDA-approved treatment to temporarily improve moderate to severe forehead lines.1

.28Years

of expertise with
onabotulinumtoxinA

almost3700publications

in scientific and medical journals
with onabotulinumtoxinA
(clinical and non-clinical studies)5

approved in97Countries6†

*VISTABEL® in most European countries.

the results that bring patients in.
and keep bringing them back.

Sandra
Moderate to severe frown lines
Moderate to severe crow’s feet
Moderate to severe crow’s feet
before
after (DAY 7)

    Actual patients. Results may vary.

    Photos taken at maximum frown and/or full smile before and after treatment with BOTOX® Cosmetic at day 7. In two clinical studies for moderate to severe crow’s feet, 26.1% and 20.3% of people had ≥ 2-grade improvement at day 30. In one of these studies, 67.9% of people had mild or no crow’s feet at day 30 after treatment. In clinical studies for moderate to severe frown lines, physicians assessed 80% of people had significant improvement at day 30.

    Side effects associated with the injection include localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising.

    BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

    WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.

    BOTOX® Cosmetic (onabotulinumtoxinA) IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

    WARNING: DISTANT SPREAD OF TOXIN EFFECT: Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

    Important Information

    Indications

    BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

    IMPORTANT SAFETY INFORMATION (continued)

    CONTRAINDICATIONS

    BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

    WARNINGS AND PRECAUTIONS

    Lack of Interchangeability between Botulinum Toxin Products
    The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

    Spread of Toxin Effect

    Please refer to Boxed Warning for Distant Spread of Toxin Effect.

    No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported.

    Serious Adverse Reactions With Unapproved Use

    Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.

    Hypersensitivity Reactions

    Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

    Cardiovascular System

    There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

    Increased Risk of Clinically Significant Effects with Pre-existing Neuromuscular Disorders

    Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).

    Dysphagia and Breathing Difficulties

    Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

    Pre-existing Conditions at the Injection Site

    Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

    Human Albumin and Transmission of Viral Diseases

    This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

    ADVERSE REACTIONS

    The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).

    The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).

    The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%) and eyelid ptosis (2%).

    DRUG INTERACTIONS

    Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.

    The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

    Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.

    USE IN SPECIFIC POPULATIONS

    There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production. 

    Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.