Botulinum toxin type b Side Effects

Some side effects of botulinum toxin type b may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to botulinum toxin type b: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking botulinum toxin type b: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these serious side effects, some of which can occur up to several weeks after an injection:

• trouble breathing, talking, or swallowing;

• hoarse voice, drooping eyelids;

• unusual or severe muscle weakness (especially in a body area that was not injected with the medication);

• loss of bladder control;

• problems with vision; or

• chest pain.

Less serious side effects of botulinum toxin type b may include:

• pain or muscle weakness near where the medicine was injected;

• headache, joint or back pain;

• dry mouth, nausea, upset stomach;

• fever, cough, sore throat, flu symptoms;

• pain or stiffness in your neck; or

• dizziness, drowsiness, anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to botulinum toxin type b: injectable solution

Cardiovascular

Cardiovascular side effects have included headache (up to 16%) and chest pain.

Dermatologic

Dermatologic side effects including pruritus have been reported in 2% of patients or less.

Gastrointestinal

Gastrointestinal side effects have included dysphagia (up to 25%), dyspepsia (up to 10%), nausea (up to 10%), and to a lesser extent (2% or less) vomiting, glossitis, stomatitis, and tooth disorder.

General

Dry mouth is the most commonly reported adverse effect (occurring in up to 34% of patients). Other general side effects have included torticollis (up to 8%) and, to a lesser extent (2% or less), fever, chills, hernia, malaise, abscess, cyst, and neoplasm.

Genitourinary

Genitourinary side effects reported in 2% of patients or less have included urinary tract infection, cystitis, and vaginal moniliasis.

Immunologic

Immunologic side effects have included infection (up to 19%) and flu syndrome (up to 9%). Other immunologic side effects reported to a lesser extent (2% or less) have included otitis media and viral infection.

Local

Local side effects including injection site pain have been reported (up to 16%).

Musculoskeletal

Musculoskeletal side effects have included neck pain related to cervical dystonia (up to 17%), torticollis (up to 8%), arthralgia (up to 7%), back pain (up to 7%), myasthenia (up to 6%), and asthenia (up to 6%). Other musculoskeletal side effects reported in 2% of patients or less have included arthritis and joint disorder.

Nervous system

Nervous system side effects reported in 2% of patients or less have included anxiety, tremor, hyperesthesia, somnolence, confusion, pain related to cervical dystonia/torticollis, vertigo, and vasodilation.

Respiratory

Respiratory side effects have included increased cough (up to 7%), rhinitis (up to 6%), and, to a lesser extent (2% or less), dyspnea, lung disorder, and pneumonia.

Ocular

Ocular side effects including a case of bilateral ptosis have been reported.

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