Dysport Side Effects

Generic Name: abobotulinumtoxinA

Note: This page contains information about the side effects of abobotulinumtoxinA. Some of the dosage forms included on this document may not apply to the brand name Dysport.

Not all side effects for Dysport may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to abobotulinumtoxinA: intramuscular powder for solution

Along with its needed effects, abobotulinumtoxinA (the active ingredient contained in Dysport) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking abobotulinumtoxinA:

More common
  • Difficulty with swallowing
  • hoarseness
  • muscle or bone pain
  • muscle weakness
  • sore throat
  • voice changes
Less common
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • body aches or pain
  • chills
  • cough
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • ear congestion
  • fever
  • general feeling of discomfort or illness
  • headache
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • joint pain
  • loss of appetite
  • loss of voice
  • muscle aches and pains
  • nasal congestion
  • nausea
  • shivering
  • shortness of breath
  • sneezing
  • stiff muscles
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble with sleeping
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Incidence not known
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • flushing or redness of the skin
  • partial or slight paralysis of the face
  • unusually warm skin

Some side effects of abobotulinumtoxinA may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • blurred vision
  • decreased vision
  • double vision
  • dry eyes
  • dry mouth
  • eye pain
  • itching of the eyes
  • problems with focusing the eyes
  • seeing double
Less common
  • Dizziness
  • drooping upper eyelids
  • pain or tenderness around the eyes and cheekbones
  • swelling of the eyelids
Incidence not known
  • Change in color vision
  • difficulty seeing at night
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • increased sensitivity of the eyes to sunlight
  • sensation of spinning

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 (the active ingredient contained in Dysport) 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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