Summary

Commonly reported side effects of incobotulinumtoxinA 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.

Serious side effects of IncobotulinumtoxinA

Along with its needed effects, incobotulinumtoxinA 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 IncobotulinumtoxinA

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