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General

BOTOX® and BOTOX® Cosmetic (onabotulinumtoxina for injection) 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 (onabotulinumtoxina for injection) .

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. (see WARNINGS).

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 (onabotulinumtoxina for injection) 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 (onabotulinumtoxina for injection) the most frequently reported adverse events following injection of BOTOX® Cosmetic (onabotulinumtoxina for injection) 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 (onabotulinumtoxina for injection) in 405 subjects aged 18 to 75 who were evaluated in the randomized, placebo-controlled clinical studies to assess the use of BOTOX® Cosmetic (onabotulinumtoxina for injection) in the improvement of the appearance of glabellar lines (see Clinical Studies). 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 (onabotulinumtoxina for injection) 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 (onabotulinumtoxina for injection) Group Compared to the Placebo Group

Immunogenicity

Treatment with BOTOX® Cosmetic (onabotulinumtoxina for injection) may result in the formation of neutralizing antibodies that may reduce the effectiveness of subsequent treatments with BOTOX® Cosmetic (onabotulinumtoxina for injection) by inactivating the biological activity of the toxin. The rate of formation of neutralizing antibodies in patients receiving BOTOX® Cosmetic (onabotulinumtoxina for injection) 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 (onabotulinumtoxina for injection) 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.

Co-administration of BOTOX® Cosmetic (onabotulinumtoxina for injection) and aminoglycosides¹ or other agents interfering with neuromuscular transmission (e.g., curare-like nondepolarizing blockers, lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases, succinylcholine chloride) should only be performed with caution as the effect of the toxin may be potentiated.

The effect of administering different botulinum neurotoxin serotypes 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.

Last reviewed on RxList: 8/12/2009
This monograph has been modified to include the generic and brand name in many instances.