AbobotulinumtoxinA Side Effects

Some side effects of abobotulinumtoxinA 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 abobotulinumtoxinA: injectable powder for injection

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

The botulinum toxin contained in Dysport 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;

• problems with vision;

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

• loss of bladder control;

• 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 of abobotulinumtoxinA may include:

• muscle weakness near where the medicine was injected;

• bruising, bleeding, pain, redness, or swelling where the injection was given;

• headache, muscle pain or 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.

For Healthcare Professionals

Applies to abobotulinumtoxinA: injectable powder for injection

Nervous system

Nervous system side effects reported during treatment for cervical dystonia have included headache (11%), and fatigue (12%).

Nervous system side effects reported during treatment for glabellar lines have included headache (37%), dizziness (1.2%), paresthesia (1%), anxiety (0.7%), and twitch (0.7%).

General

In general, side effects occur in the first week following administration of abobotulinumtoxinA and are generally transient; however, there are some reports of several months duration. Most adverse events were reported as mild or moderate in severity.

Cardiovascular

Cardiovascular side effects in one study reported during treatment for cervical dystonia showed a statistically significant reduction in heart rate compared to baseline, averaging about 3 beats per minute, observed 30 minutes after injection.

Cardiovascular side effects reported during treatment for glabellar lines have included hypertension (1%).

Gastrointestinal

Gastrointestinal side effects reported during treatment for cervical dystonia have included dry mouth (13%), and dysphagia (15%).

Gastrointestinal side effects reported during treatment for glabellar lines have included nausea (6%).

Genitourinary

Genitourinary side effects reported during treatment for glabellar lines have included blood urine present (6%).

Hepatic

Hepatic side effects reported during treatment for glabellar lines have included abnormal liver function tests (0.7%).

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylaxis, urticaria, soft tissue edema, and dyspnea.

Metabolic

Metabolic side effects reported during treatment for cervical dystonia have included a small increase from baseline (0.23 mol/L) in mean blood glucose relative to placebo-treated patients, which could be a factor in patients whose diabetes is difficult to control.

Ocular

Ocular side effects reported during treatment for cervical dystonia occurring in greater than 5% of subjects have included eye disorders (consisting of blurred vision, diplopia, and reduced visual acuity and accommodation).

Ocular side effects reported during treatment for glabellar lines have included eyelid edema (8%), and eyelid ptosis (6%).

Local

Local side effects reported during treatment for cervical dystonia have included injection site discomfort (13%), and injection site pain (5%).

Local side effects reported during treatment for glabellar lines have included injection site pain (11%) and injection site reaction (12%).

Respiratory

Respiratory side effects reported during treatment for cervical dystonia have included dysphonia (6%), and breathing difficulties which were usually mild (3%).

Respiratory side effects reported during treatment for glabellar lines have included nasopharyngitis (38%), upper respiratory tract infection (12%), and sinusitis (8%).

Musculoskeletal

Musculoskeletal side effects reported during treatment for cervical dystonia have included muscle weakness (16%), neck pain (greater than 5%), and musculoskeletal pain (7%).

Musculoskeletal side effects reported during treatment for glabellar lines have included muscle weakness (2%).

Immunologic

Immunologic side effects reported during treatment for cervical dystonia have included infections and infestations (13%).

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