Note: This document contains side effect information about incobotulinumtoxinA. Some dosage forms listed on this page may not apply to the brand name Xeomin.
Summary
Common side effects of Xeomin include: asthenia, blepharoptosis, dysphagia, myasthenia, neck pain, visual disturbance, and xerostomia. Other side effects include: dyspnea, diarrhea, musculoskeletal pain, and pain at injection site. Continue reading for a comprehensive list of adverse effects.
Applies to incobotulinumtoxinA: powder for solution.
Warning
Intramuscular route (Powder for Solution)
Distant Spread of Toxin EffectThe effects of incobotulinumtoxinA 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 Xeomin
Along with its needed effects, incobotulinumtoxinA (the active ingredient contained in Xeomin) 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 incobotulinumtoxinA:
More common—for blepharospasm
- Dry eyes
- fever
More common—for cervical dystonia
- Chills
- cough
- difficulty with swallowing
- lower back or side pain
- muscle or bone pain
- muscle weakness
- painful or difficult urination
- pain in the neck
Less common—for blepharospasm
- Difficult or labored breathing
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common—for sialorrhea
- Blurred vision
- cough producing mucus
- difficulty breathing
- dizziness
- falls
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
- sore throat
- tightness in the chest
Less common—for upper limb spasticity
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- seizures
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Rare—for glabellar lines
- Itching, pain, redness, or swelling at the injection site
- pain in the face
- swelling of the eyelids
Incidence not known
- Changes in patterns and rhythms of speech
- fast heartbeat
- fever
- hives, itching, or rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- muscle spasm
- pain at the injection site
- redness of the skin
- slurred speech
- swelling of the eyes or eyelids
- swelling of the face, lips, hands, or feet
- tightness in the chest
- trouble with speaking
- trouble breathing or swallowing
Other side effects of Xeomin
Some side effects of incobotulinumtoxinA 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—for blepharospasm
- Blurred vision
- diarrhea
- drooping upper eyelids
- dry mouth
- headache
Less common—for sialorrhea
- Back pain
- diarrhea
- dry eye
- dry mouth
- hoarseness
- voice changes
Less common—for upper limb spasticity
- Dry mouth
Rare—for glabellar lines
- Drooping of the eyelids
- increased blinking
- twitching of the eyelids
Incidence not known
- Difficulty with moving
- joint pain or swelling
- muscle ache, cramps, pain, or stiffness
- nausea
- painful blisters on the trunk of the body
For Healthcare Professionals
Applies to incobotulinumtoxinA: intramuscular powder for injection.
General
The frequency of adverse reactions varies based on usage. The more frequently reported adverse events in the chronic sialorrhea trials included tooth extraction, dry mouth, diarrhea, and hypertension; in the upper limb spasticity trials, seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection; in the cervical dystonia trials, dysphagia, neck pain, and muscle weakness; for blepharospasm, eyelid ptosis, dry eye, and dry mouth; and for treating glabellar lines, the most frequently reported adverse event was headache.
Local
Common (1% to 10%): Injection site pain, injection site hematoma
Very rare (less than 0.01%): Spread of toxin
Frequency not reported: Injection site reaction, allergic dermatitis, localized allergic reactions (e.g., welling, edema, erythema, pruritus, rash), herpes zoster[Ref]
Respiratory
Common (1% to 10%): Asthma, nasopharyngitis, respiratory tract infection, dyspnea, bronchitis[Ref]
Hypersensitivity
Postmarketing reports: Localized allergic reactions, hypersensitivity, allergic dermatitis[Ref]
Hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported with botulinum toxin products. Localized allergic reactions reported during the postmarketing period with this drug include swelling, edema, erythema, pruritus, or rash.[Ref]
Ocular
Common (1% to 10%): Dry eye (19%), eyelid ptosis (19%)
Uncommon (0.1% to 1%): Impaired vision, blurred vision, lacrimation increased, eye swelling, eyelid edema, diplopia[Ref]
Musculoskeletal
Very common (10% or more): Neck pain (up to 16%), muscular weakness (up to 14%)
Common (1% to 10%): Musculoskeletal pain, muscle spasms, musculoskeletal stiffness, back pain
Uncommon (0.1% to 1%): Pain in extremity, muscular weakness, dysarthria, myalgia[Ref]
Nervous system
Common (1% to 10%): Headache, dizziness, epilepsy, dysphonia
Uncommon (0.1% to 1%): Speech disorder, dysesthesia[Ref]
Gastrointestinal
Very common (10% or more): Dysphagia (18%), dry mouth (16%)
Common (1% to 10%): Diarrhea, nausea, oropharyngeal pain, lip disorder, viral gastroenteritis, tooth extraction[Ref]
Immunologic
Common (1% to 10%): Sinusitis, nasopharyngitis, respiratory tract infection, viral gastroenteritis, tooth infection
Postmarketing reports: Flu-like symptoms, herpes zoster[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Cardiovascular
Common (1% to 10%): Hypertension[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia, hyperglycemia[Ref]
Other
Common (1% to 10%): Asthenia
Uncommon (0.1% to 1%): Dysphonia, facial paresis, feeling hot
Rare (less than 0.1%): Tenderness[Ref]
Dermatologic
Postmarketing reports: Allergic dermatitis
