Summary
Commonly reported side effects of abobotulinumtoxinA include: dysphagia, headache, myasthenia, nasopharyngitis, voice disorder, and xerostomia. Continue reading for a comprehensive list of adverse effects.
Applies to abobotulinumtoxinA: intramuscular powder for solution.
Warning
Intramuscular route (Powder for Solution)
The effects of abobotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
Serious side effects of AbobotulinumtoxinA
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
- Blurred vision
- decreased vision
- difficulty with swallowing or speaking
- double vision
- dry eyes
- eye pain
- hoarseness
- itching of the eyes
- muscle or bone pain
- muscle weakness
- problems with focusing of the eyes
- seeing double
- seizures
- stuffy or runny nose
- 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
- 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
- change in color vision
- difficulty seeing at night
- dizziness
- fast heartbeat
- flushing or redness of the skin
- hives, itching, rash
- increased sensitivity of the eyes to sunlight
- partial or slight paralysis of the face
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusually warm skin
Other side effects of AbobotulinumtoxinA
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
- dry mouth
Less common
- Drooping upper eyelids
- pain or tenderness around the eyes and cheekbones
Incidence not known
- Dizziness or lightheadedness
- feeling of constant movement of self or surroundings
- sensation of spinning
For Healthcare Professionals
Applies to abobotulinumtoxinA: injectable powder for injection, intramuscular powder for injection.
General
The most commonly occurring side effects have included muscular weakness, dysphagia, dry mouth, injection site pain and discomfort, fatigue, headache, and nasopharyngitis.
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, peripheral edema[Ref]
Gastrointestinal
Very common (10% or more): Dysphagia (up to 39%), dry mouth (up to 39%)
Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, gastroenteritis[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
Postmarketing reports: Hypersensitivity reactions including anaphylaxis[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
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%)
Common (1% to 10%): Injection site pain[Ref]
Respiratory
Very common (10% or more): Nasopharyngitis (10%), upper respiratory infection (10%)
Common (1% to 10%): Breathing difficulty, dyspnea, sinusitis, cough, pharyngitis, bronchitis, rhinitis, oropharyngeal pain[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, wrist fracture
Uncommon (0.1% to 1%): Gait disturbance, hypertonia
Postmarketing reports: Amyotrophy[Ref]
Immunologic
Common (1% to 10%): Infection, influenza, neutralizing antibodies[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, ear infection, pyrexia
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, insomnia[Ref]
