IncobotulinumtoxinA Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 23, 2025.

Applies to incobotulinumtoxinA: powder for solution.

Precautions

It is very important that your doctor check your progress closely and at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may cause serious allergic reactions, including anaphylaxis and serum sickness, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble breathing or swallowing, fever, joint swelling, muscle aches, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may make your muscles weak and cause eye or vision problems (eg, bleeding inside the eye). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (eg, corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.

After you have received this medicine and your vision or muscle spasms get better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, talk with your doctor.

A part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

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

For healthcare professionals

Applies to incobotulinumtoxinA: intramuscular powder for injection.

General adverse events

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

See also:

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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer