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AbobotulinumtoxinA Side Effects

In Summary

Commonly reported side effects of abobotulinumtoxinA include: dysphagia, myasthenia, voice disorder, nasopharyngitis, headache, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to abobotulinumtoxinA: intramuscular powder for solution

In addition to its needed effects, some unwanted effects may be caused by abobotulinumtoxinA. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking abobotulinumtoxinA, check with your doctor or nurse immediately:

More common:
  • Difficulty with swallowing or speaking
  • 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
  • nausea
  • shivering
  • sneezing
  • stiff muscles
  • stuffy or runny nose
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
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

Severity: Minor

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

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

Very common (10% or more): Dysphonia (up to 28%), headache (11%), facial paresis (up to 11%)
Common (1% to 10%): Dizziness, convulsion, syncope, hypoesthesia, partial seizures[Ref]

Cardiovascular

Common (1% to 10%): Hypertension[Ref]

Gastrointestinal

Very common (10% or more): Dysphagia (up to 39%), dry mouth (up to 39%)
Common (1% to 10%): Nausea, diarrhea, constipation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, blood present in urine[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, urticaria, soft tissue edema[Ref]

Metabolic

Frequency not reported: Blood triglycerides increased[Ref]

Ocular

Very common (10% or more): Eye disorders (e.g., vision blurred, diplopia, visual acuity reduced, eye pain, eyelid disorder, accommodation disorder, dry eye, eye pruritus) (up to 17%)
Common (1% to 10%): Eyelid edema, eyelid ptosis, about 3% of patients developed antibodies to this drug
Postmarketing reports: Photophobia[Ref]

Local

Very common (10% or more): Injection site discomfort (e.g., pain, bruising, hemorrhage, injection site erythema/hematoma) (up to 22%)[Ref]

Respiratory

Very common (10% or more): Nasopharyngitis (10%)
Common (1% to 10%): Breathing difficulty, dyspnea, upper respiratory tract infection, sinusitis, cough[Ref]

Musculoskeletal

Very common (10% or more): Muscular weakness (up to 56%)
Common (1% to 10%): Musculoskeletal pain, muscle atrophy, pain in extremity, back pain
Uncommon (0.1% to 1%): Gait disturbance, hypertonia
Postmarketing reports: Amyotrophy, facial paresis[Ref]

Immunologic

Common (1% to 10%): Infection, influenza[Ref]

Dermatologic

Frequency not reported: Excessive granulation tissue, erythema[Ref]

Other

Very common (10% or more): Fatigue (12%)
Common (1% to 10%): Fall, injury, contusion
Uncommon (0.1% to 1%): Sensation of heaviness
Frequency not reported: Distant spread of toxin effects
Postmarketing reports: Vertigo, burning sensation, hypoesthesia

Psychiatric

Common (1% to 10%): Depression[Ref]

References

1. "Product Information. Dysport (abobotulinumtoxinA)." Tercica Inc, Brisbane, CA.

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

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