Botox Cosmetic Side Effects

Generic Name: onabotulinumtoxina

Please note - some side effects for Botox Cosmetic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Botox Cosmetic - for the Consumer

Botox Cosmetic

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Botox Cosmetic:

Anxiety; back pain; dizziness; drowsiness; dry mouth; dry or irritated eyes; facial pain; flu-like symptoms; headache; inability to focus eyes; increased cough; indigestion; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; stiff or weak muscles at or near the injection site; sweating.

Seek medical attention right away if any of these SEVERE side effects occur when using Botox Cosmetic:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bleeding at the injection site; chest pain; difficulty swallowing or breathing; double or blurred vision or other vision changes; drooping of the upper eyelid; eyelid swelling; fainting; fever, chills, or persistent sore throat; irregular heartbeat; loss of bladder control; loss of strength; paralysis; seizures; severe or persistent muscle weakness or dizziness; shortness of breath; speech changes or problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Botox Cosmetic Side Effects - for the Professional

Botox Cosmetic

General

BOTOX® and BOTOX® Cosmetic contain the same active ingredient in the same formulation. Therefore adverse events observed with the use of BOTOX® also have the potential to be associated with the use of BOTOX® Cosmetic.

The most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility.

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 pre-existing cardiovascular disease.

New onset or recurrent seizures have also been reported, typically in patients who are predisposed to experiencing these events. The exact relationship of these events to the botulinum toxin injection has not been established. Additionally, a report of acute angle closure glaucoma one day after receiving an injection of botulinum toxin for blepharospasm was received, with recovery four months later after laser iridotomy and trabeculectomy. Focal facial paralysis, syncope and exacerbation of myasthenia gravis have also been reported after treatment of blepharospasm.

In general, adverse events 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. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of adjacent muscles may also occur due to spread of toxin.

Glabellar Lines

In clinical trials of BOTOX® Cosmetic the most frequently reported adverse events following injection of BOTOX® Cosmetic were headache*, respiratory infection*, flu syndrome*, blepharoptosis and nausea.

Less frequently occurring (<3%) adverse reactions included pain in the face, erythema at the injection site*, paresthesia* and muscle weakness. While local weakness of the injected muscle(s) is representative of the expected pharmacological action of botulinum toxin, weakness of adjacent muscles may occur as a result of the spread of toxin. These events are thought to be associated with the injection and occurred within the first week. The events were generally transient but may last several months or longer.
(* incidence not different from Placebo)

The data described in Table 4 reflect exposure to BOTOX® Cosmetic in 405 subjects 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. Adverse events of any cause were reported for 44% of the BOTOX® Cosmetic treated subjects and 42% of the placebo treated subjects. The incidence of blepharoptosis was higher in the BOTOX® Cosmetic treated arm than in placebo (3% vs. 0).

In the open-label, repeat injection study, blepharoptosis was reported for 2% (8/373) of subjects in the first treatment cycle and 1% (4/343) of subjects in the second treatment cycle. Adverse events of any type were reported for 49% (183/373) of subjects overall. The most frequently reported of these adverse events in the open-label study included respiratory infection, headache, flu syndrome, blepharoptosis, pain and nausea.

Because clinical trials are conducted under widely varying conditions, 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 be predictive of rates observed in practice.

TABLE 4. Adverse Events Reported at Higher Frequency (>1%) in the BOTOX® Cosmetic Group Compared to the Placebo Group

	Percent of Patients Reporting Adverse Events
Adverse Events by Body System	BOTOX® Cosmetic (N=405) %	Placebo (N=130) %
Overall	44	42
Body as a Whole
Pain in Face	2	1
Skin and Appendages
Skin Tightness	1	0
Digestive System
Nausea	3	2
Dyspepsia	1	0
Tooth Disorder	1	0
Special Senses
Blepharoptosis	3	0
Musculoskeletal System
Muscle Weakness	2	0
Cardiovascular
Hypertension	1	0

Immunogenicity

Treatment with BOTOX® Cosmetic may result in the formation of neutralizing antibodies that may reduce the effectiveness of subsequent treatments with BOTOX® Cosmetic by inactivating the biological activity of the toxin. The rate of formation of neutralizing antibodies in patients receiving BOTOX® Cosmetic has not been well studied.

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 the lowest effective dose given at the longest feasible intervals between injections.

Postmarketing Experience

Transient ptosis, the most frequently reported complication, has been reported in the literature in approximately 5% of patients. There has been a single report of diplopia, which resolved completely in three weeks.

The following other adverse reactions have been identified since the drug has been marketed: abdominal pain; blurred vision; brachial plexopathy; decreased hearing; diarrhea; ear noise; erythema multiforme; fever; focal facial paralysis; glaucoma; localized numbness; loss of appetite; malaise; myalgia; myasthenia gravis; pruritus; psoriasiform eruption; retinal vein occlusion; sweating; syncope; vertigo with nystagmus; and vomiting.

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 botulinum toxin.

Reporting Adverse Events

Adverse events following use of BOTOX® Cosmetic should be reported to the Pharmacovigilance Department, Allergan Inc. (1-800-433-8871). Adverse events may also be reported to the U.S. Department of Health and Human Services (DHHS) Adverse Event Reporting System. Report forms and reporting requirement information can be obtained from Adverse Event Reporting System (AERS) through a toll free number 1-800-822-7967.

Overdosage

Excessive doses of BOTOX® Cosmetic may be expected to produce neuromuscular weakness with a variety of symptoms.

Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur or overdose be suspected, the person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection. These patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization.

If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place. Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.

In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration. In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 1-770-488-7100. More information can be obtained at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5232a8.htm.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects have included nausea (2 to 3%), oral dryness (2 to 10%), and dysphagia (2 to 10%).

Nervous system

Nervous system side effects have included fatigue (2 to 3%), dizziness (2 to 10%), fever (2 to 10%), drowsiness (2 to 10%), and numbness (2 to 10%). New or recurrent seizures have been reported, usually in patients who are predisposed to experiencing these events. The exact relationship of these events to the injection of onabotulinumtoxinA has not been established.

Respiratory

Respiratory side effects have included bronchitis (2 to 3%), increased cough (2 to 10%), rhinitis (2 to 10%), and dyspnea (2 to 10%).

Musculoskeletal

Musculoskeletal side effects have included pain in extremity (6%), muscle weakness (4%), asthenia (2 to 10%), back pain (2 to 10%), hypertonia (2 to 10%), and stiffness (2 to 10%).

Cardiovascular

Cardiovascular side effects have included arrhythmia and myocardial infarction, some with fatal outcomes. Some patients had risk factors including cardiovascular disease. The exact relationship of these events to the injection of onabotulinumtoxinA has not been established.

Local

Local side effects have included soreness at injection site (2 to 10%).

Immunologic

Immunologic side effects have included flu syndrome (2 to 10%).

Ocular

In two cases of VII nerve disorder, reduced blinking from onabotulinumtoxinA injection of the orbicularis muscle led to serious corneal exposure, persistent epithelial defect, corneal ulceration and a case of corneal perforation. Focal facial paralysis, syncope, and exacerbation of myasthenia gravis have also been reported after treatment of blepharospasm.

Extraocular muscles adjacent to the injection site can be affected, causing vertical deviation, especially with higher doses of onabotulinumtoxinA. The incidence rates of these adverse effects in 2058 adults who received a total of 3650 injections for horizontal strabismus was 17%.

The incidence of ptosis has been reported to be dependent on the location of the injected muscles, 1% after inferior rectus injections, 16% after horizontal rectus injections and 38% after superior rectus injections.

In a series of 5587 injections, retrobulbar hemorrhage occurred in 0.3% of cases.

Ocular side effects have included diplopia (2 to 10%) and ptosis (2 to 10%). Other events reported in prior clinical studies in decreasing order of incidence include: irritation, tearing, lagophthalmos, photophobia, ectropion, keratitis, diplopia, entropion, diffuse skin rash, and local swelling of the eyelid skin lasting for several days following eyelid injection.

Other

Other side effects have included speech disorder (2 to 10%). Other side effects reported postmarketing have included abdominal pain, anorexia, brachial plexopathy, diarrhea, facial palsy, facial paresis, hyperhidrosis, hypoacusis, hypoesthesia, localized numbness, malaise, myalgia, paresthesia, pyrexia, radiculopathy, skin rash (including erythema multiforme, and psoriasiform eruption), tinnitus, vertigo, visual disturbances, and vomiting.

Other

Side effects occurring most commonly in patients with cervical dystonia have included dysphagia (19%), upper respiratory infection (12%), neck pain (11%), and headache (11%). One female patient treated for cervical dystonia developed brachial plexopathy 2 days after injection of 120 Units of onabotulinumtoxinA.

Other

Other side effects occurring after treatment for axillary hyperhidrosis at a frequency of 3 to 10% have included injection site pain and hemorrhage, non-axillary sweating, infection, pharyngitis, flu syndrome, headache, fever, neck or back pain, pruritus, and anxiety.

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