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Botox Cosmetic

Last reviewed on RxList: 2/25/2019
Botox Cosmetic Side Effects Center

Last reviewed on RxList 2/25/2019

Botox Cosmetic (onabotulinumtoxinA) is an injectable neuro-toxin used for reducing frown lines in adults 65 years of age or younger. Side effects of Botox Cosmetic include:

  • allergic reactions,
  • rash,
  • itching,
  • headache,
  • neck or back pain,
  • difficulty swallowing,
  • shortness of breath,
  • nausea,
  • diarrhea,
  • stomach pain,
  • loss of appetite,
  • muscle weakness where the medicine was injected,
  • injection site reactions (bruising, bleeding, pain, redness, swelling, or tenderness),
  • muscle stiffness,
  • fever,
  • cough,
  • sore throat,
  • runny nose,
  • flu symptoms,
  • dizziness,
  • drowsiness,
  • tired feeling,
  • dry mouth,
  • dry eyes,
  • ringing in your ears,
  • increased sweating in areas other than the underarms,
  • itchy or watery eyes,
  • increased sensitivity to lights, or
  • eyelid swelling or bruising

Botox Cosmetic is administered by injection. Administration of Botox Cosmetic with other agents (for example, aminoglycosides, curare) that affect neuromuscular function may increase the effect of botulinum toxin. There are no adequate studies of Botox Cosmetic in pregnant women and it has not been evaluated in nursing mothers.

Our Botox Cosmetic Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Botox Cosmetic Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult 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);
  • trouble breathing, talking, or swallowing;
  • loss of bladder control;
  • hoarse voice, drooping eyelids;
  • 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, problems with vision.

Common side effects may include:

  • muscle weakness near where the medicine was injected;
  • trouble swallowing for several months after treatment;
  • muscle stiffness, neck pain, pain in your arms or legs;
  • blurred vision, puffy eyelids, dry eyes, drooping eyebrows;
  • dry mouth;
  • headache, tiredness;
  • 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.

Read the entire detailed patient monograph for Botox Cosmetic (OnabotulinumtoxinA for Injection)

Botox Cosmetic Professional Information

SIDE EFFECTS

The following adverse reactions to BOTOX Cosmetic (onabotulinumtoxinA) for injection are discussed in greater detail in other sections of the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

BOTOX and BOTOX Cosmetic contain the same active ingredient in the same formulation, but have different labeled Indications and Usage. Therefore, adverse events observed with the use of BOTOX also have the potential to be observed with the use of BOTOX Cosmetic.

In general, adverse reactions occur within the first week following injection of BOTOX Cosmetic and while generally transient, may have a duration of several months or longer. Localized pain, infection, inflammation, tenderness, swelling, erythema, and/or bleeding/bruising may be associated with the injection. Needle-related pain and/or anxiety may result in vasovagal responses (including e.g., syncope, hypotension), which may require appropriate medical therapy.

Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of nearby muscles may also occur due to spread of toxin [see WARNINGS AND PRECAUTIONS].

Glabellar Lines

Table 2 lists selected adverse reactions reported by >1% of BOTOX Cosmetic treated subjects (N=405) aged 18 to 75 who were evaluated in the randomized, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of glabellar lines.

Table 2: Adverse Reactions Reported by >1% of BOTOX Cosmetic treated Subjects and More Frequent than in Placebo-treated Subjects in Double-blind, Placebo-controlled Clinical Studies of Treatment of Glabellar Lines

Adverse Reactions by System Organ Class BOTOX Cosmetic
(N=405)
Placebo
(N=130)
General Disorders and Administration Site Conditions
Facial pain 6 (1%) 0 (0%)
Nervous System Disorders
Facial paresis 5 (1%) 0 (0%)
Eye Disorders
Eyelid ptosis 13 (3%) 0 (0%)
Musculoskeletal and Connective Tissue Disorders
Muscular Weakness 6 (1%) 0 (0%)

Lateral Canthal Lines

Table 3 lists selected adverse reactions reported within 90 days following injection by ≥1% of BOTOX Cosmetic treated subjects (N=526) aged 18 to 75 who were evaluated in two randomized, double-blind, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of lateral canthal lines alone.

Table 3: Adverse Reaction Reported by ≥1% of BOTOX Cosmetic treated Subjects and More Frequent than in Placebo-treated Subjects Within 90 Days, in Double-blind, Placebo-controlled Clinical Studies of Treatment of Lateral Canthal Lines

Adverse Reactions by System Organ Class BOTOX Cosmetic 24 Units
(N=526)
Placebo
(N=530)
Eye disorders
Eyelid edema 5 (1%) 0 (0%)

Forehead Lines

Table 4 lists selected adverse reactions reported by ≥1% of BOTOX Cosmetic treated subjects (N=665) aged 18 to 77 who were evaluated in two randomized, double-blind, placebo-controlled clinical studies to assess the use of BOTOX Cosmetic in the improvement of the appearance of forehead lines with glabellar lines.

Table 4: Adverse Reactions Reported by ≥1% of BOTOX Cosmetic treated Subjects and More Frequent than in Placebo-treated Subjects, in Double-blind, Placebo-controlled Clinical Studies of Treatment of Forehead Lines

Adverse Reactions by System Organ Class BOTOX Cosmetic (20 Units forehead lines with 20 Units glabellar lines)
(N=665)
Placebo
(N=315)
Nervous System Disorders
Headache 58 (9%) 17 (5%)
Eye Disorders
Eyelid ptosis 12 (2%) 1 (0%)
Skin and Subcutaneous Tissue Disorders
Brow ptosis 13 (2%) 0 (0%)
Skin tightness 10 (2%) 0 (0%)

There were no additional adverse drug reactions reported with the simultaneous treatment of forehead lines, glabellar lines, and lateral canthal lines.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to BOTOX Cosmetic in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Treatment with botulinum toxins may result in the formation of neutralizing antibodies that may reduce the effectiveness of subsequent treatments by inactivating biological activity of the toxin.

In three Lateral Canthal Line trials, 916 subjects (517 subjects at 24 Units and 399 subjects at 44 Units) treated with BOTOX Cosmetic had specimens analyzed for antibody formation. Among the 916 BOTOX Cosmetic treated subjects, 14 subjects (1.5%) developed binding antibodies and no subjects (0%) developed the presence of neutralizing antibodies.

The data reflect the subjects whose test results were considered positive or negative for neutralizing activity to BOTOX Cosmetic in a mouse protection assay.

The critical factors for neutralizing antibody formation have not been well characterized. The results from some studies suggest that botulinum toxin injections at more frequent intervals or at higher doses may lead to greater incidence of antibody formation. The potential for antibody formation may be minimized by injecting with the lowest effective dose given at the longest feasible intervals between injections.

Post-marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility or anaphylaxis, after treatment with botulinum toxin [see WARNINGS AND PRECAUTIONS].

There have also been reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease.

New onset or recurrent seizures have also been reported, typically in patients who are predisposed to experiencing these events.

The following adverse reactions by System Organ Class have been identified during post-approval use of BOTOX/BOTOX Cosmetic:

Ear And Labyrinth Disorders

Hypoacusis; tinnitus; vertigo

Eye Disorders

Diplopia; dry eye; lagophthalmos; strabismus; visual disturbances; vision blurred

Gastrointestinal Disorders

Abdominal pain; diarrhea; dry mouth; nausea; vomiting

General Disorders And Administration Site Conditions

Denervation; malaise; pyrexia

Metabolism And Nutrition Disorders

Anorexia

Musculoskeletal And Connective Tissue Disorders

Localized muscle twitching/involuntary muscle contractions; muscle atrophy; myalgia

Nervous System Disorders

Brachial plexopathy; dysarthria; facial palsy; hypoaesthesia; localized numbness; myasthenia gravis; paresthesia; peripheral neuropathy; radiculopathy; syncope

Respiratory, Thoracic And Mediastinal Disorders

Aspiration pneumonia; dyspnea; respiratory depression and/or respiratory failure

Skin And Subcutaneous Tissue Disorders

Alopecia, including madarosis; hyperhidrosis; pruritus; skin rash (including erythema multiforme, dermatitis psoriasiform, and psoriasiform eruption)

Read the entire FDA prescribing information for Botox Cosmetic (OnabotulinumtoxinA for Injection)

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Read the Botox Cosmetic User Reviews »

© Botox Cosmetic Patient Information is supplied by Cerner Multum, Inc. and Botox Cosmetic Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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