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AbobotulinumtoxinA Side Effects

For the Consumer

Applies to abobotulinumtoxinA: intramuscular powder for solution

Along with its needed effects, abobotulinumtoxinA 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 or speaking
  • hoarseness
  • muscle or bone pain
  • muscle weakness
  • seizures
  • 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
  • dizziness
  • fast heartbeat
  • flushing or redness of the skin
  • hives, itching, rash
  • partial or slight paralysis of the face
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • 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 of the eyes
  • seeing double
Less common
  • Drooping upper eyelids
  • pain or tenderness around the eyes and cheekbones
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, intramuscular 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.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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