IncobotulinumtoxinA Side Effects

Some side effects of incobotulinumtoxinA may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to incobotulinumtoxinA: intramuscular powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking incobotulinumtoxinA: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in this medication 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 side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;

• hoarse voice, drooping eyelids;

• blurred vision, double vision;

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• loss of strength, loss of bladder control;

• wheezing, tightness in your chest;

• eye pain or irritation;

• severe skin rash or itching; or

• feeling like you might pass out.

Common side effects may include:

• neck pain;

• dry eyes;

• headache, tired feeling;

• diarrhea;

• eyelid swelling or bruising, blinking less than usual; or

• 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.

For Healthcare Professionals

Applies to incobotulinumtoxinA: intramuscular powder for injection

Musculoskeletal

Musculoskeletal side effects have included neck pain (7% to 15%), muscular weakness (7% to 11%), musculoskeletal pain (4% to 7%), and muscle spasm.

Gastrointestinal

Gastrointestinal side effects have included dysphagia (13%), dry mouth (16%), diarrhea (8%), and nausea.

Nervous system

Nervous system side effects have included headache (7%).

Local

Local side effects have included injection site pain (9%), injection site reaction, allergic dermatitis, localized allergic reactions like swelling, edema, erythema, pruritus or rash, and herpes zoster.

Ocular

Ocular side effects have included eyelid ptosis (19%), dry eye (16%), visual impairment (12%), eye swelling, and eyelid edema.

Respiratory

Respiratory side effects have included nasopharyngitis (5%), respiratory tract infection (5%), and dyspnea (5%).

Immunologic

Immunologic side effects have included infections and infestations (13% to 14%).

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