Botulinum toxin type B Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Botulinum toxin type B - for the Consumer

Botulinum Toxin Type B

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Botulinum Toxin Type B:

Anxiety; back pain; dizziness; drowsiness; dry eyes; dry mouth; flu-like symptoms; headache; increased cough; nausea; neck pain; pain, redness, swelling, or tenderness at the injection site; runny nose; sensitivity to light; sweating; upset stomach; weakness of the muscles at or near the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding at the injection site; chest pain; difficulty swallowing; fever; irregular heartbeat; paralysis; pneumonia; seizures; shortness or breath; speech changes or problems; swelling of the hands or feet; unusual weakness; vaginal irritation, odor, or discharge; vision changes.

Side Effects by Body System

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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