IncobotulinumtoxinA Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.

Applies to incobotulinumtoxinA: powder for solution.

Important warnings This medicine can cause some serious health issues

Intramuscular route (powder for solution)

Distant Spread of Toxin Effect. The 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 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
• chest tightness
• cough producing mucus
• difficulty breathing
• dizziness
• falls
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sore throat

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
• chest tightness
• 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
• 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

Frequently asked questions

• What is botulinum toxin used to treat?

Further information

IncobotulinumtoxinA side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer