Most Common Adverse Events – BOTOXCosmetic.com

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Administering BOTOX^® Cosmetic

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Localized, pinpoint injections

Adverse Event	BOTOX^® Cosmetic Double-blind Study Period (n=405)	Placebo Double-blind Study Period (n=130)
Headache	13.3%	17.7%
Respiratory infection	3.5%	3.8%
Blepharoptosis	3.2%	0.0%
Nausea	3.0%	2.3%
Flu syndrome	2.0%	1.5%

Blepharoptosis is consistent with the pharmacologic action of BOTOX^® Cosmetic and may be technique-related¹

Less frequently occurring (<3%) adverse reactions included pain in the face, erythema at the injection site, and muscle weakness. These events are thought to be associated with the injection and occurred within the first week.

1. BOTOX^® Cosmetic [package insert] Irvine, Calif: Allergan, Inc; 2002.

BOTOX^® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in patients 18 to 65 years of age.

Important Safety Information

BOTOX^® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation. There have been rare reports of adverse events involving the cardiovascular system. Serious and/or immediate hypersensitivity reactions have been reported rarely. These reactions include anaphylaxis, urticaria, soft-tissue edema, and dyspnea.

The most common adverse events following injection include blepharoptosis and nausea. Localized pain, infection, inflammation, tenderness, swelling, erythema and/or bleeding/bruising may be associated with the injection. Patients with neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious adverse events.

Please see the additional safety information and full prescribing information.

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