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Botox Cosmetic

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Botox Cosmetic

Botox Cosmetic Side Effects Center

Pharmacy Author: Omudhome Ogbru, PharmD
Medical Editor: Melissa Conrad Stöppler, MD

Botox Cosmetic (onabotulinumtoxinA) is an injectable neuro-toxin is used for reducing frown lines in adults 65 years of age or younger. Side effects include allergic reactions, rash, itching, headache, neck pain, difficulty swallowing, shortness of breath, nausea, weakness, and pain or tenderness at the injection site.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Botox Cosmetic in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; 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 botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

  • trouble breathing, talking, or swallowing;
  • hoarse voice, drooping eyelids;
  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
  • loss of bladder control;
  • problems with vision;
  • crusting or drainage from your eyes;
  • severe skin rash or itching;
  • fast, slow, or uneven heartbeats; or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, general ill feeling.

Less serious side effects may include:

  • muscle weakness near where the medicine was injected;
  • bruising, bleeding, pain, redness, or swelling where the injection was given;
  • headache, muscle stiffness, neck or back pain;
  • fever, cough, sore throat, runny nose, flu symptoms,
  • dizziness, drowsiness, tired feeling;
  • nausea, diarrhea, stomach pain, loss of appetite;
  • dry mouth, dry eyes, ringing in your ears;
  • increased sweating in areas other than the underarms;
  • itchy or watery eyes, increased sensitivity to light; or
  • eyelid swelling or bruising.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Botox Cosmetic Overview - Patient Information: Side Effects

SIDE EFFECTS: Because this medication is given at the site of your condition, most of the side effects occur close to where the medication is injected. Redness, bruising, infection, and pain at the injection site may occur.

Dizziness, mild difficulty swallowing, respiratory infections such as cold or flu, pain, nausea, headache, and muscle weakness may occur when this medication is used to relax muscles. Double vision, drooping or swollen eyelid, eye irritation, dry eyes, tearing, reduced blinking, and increased sensitivity to light may also occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly. You may require protective eye drops/ointments, an eye patch, or other treatment.

When this medication is used to prevent migraines, side effects such as headache, neck pain, and drooping eyelid may occur.

When this medication is used for excessive sweating, side effects such as non-underarm sweating, respiratory infections such as cold or flu, headache, fever, neck or back pain, and anxiety may occur.

When this medication is used for overactive bladder, side effects such as urinary tract infections, burning/painful urination, fever, or difficulty urinating may occur.

If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: itching/swelling (especially of the face/tongue/throat), rash, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Botox Cosmetic (OnabotulinumtoxinA for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Botox Cosmetic FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 the BOTOX Cosmetic treated Patients and More Frequent than in Placebo-treated Patients 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 Patients and More Frequent than in Placebo-treated Patients Within 90 Days, in Double-blind, Placebo-controlled Clinical Studies of Treatment of Lateral Cantal Lines

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

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity. 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 results of these tests are 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 with the incidence of antibodies to other products may be misleading.

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; 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

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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Botox Cosmetic - User Reviews

Botox Cosmetic User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Botox Cosmetic sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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