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RimabotulinumtoxinB Side Effects

In Summary

Commonly reported side effects of rimabotulinumtoxinB include: dysphagia, dyspepsia, nausea, pain, and xerostomia. Other side effects include: asthenia, myasthenia, back pain, increased cough, and influenza. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to rimabotulinumtoxinB: intramuscular solution

Along with its needed effects, rimabotulinumtoxinB 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 rimabotulinumtoxinB:

More common
  • Difficulty with swallowing
  • infection
  • neck pain
  • uncontrolled twisting movements of the neck
Rare
  • Difficulty with breathing or speaking
  • muscle weakness

Some side effects of rimabotulinumtoxinB 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
  • Acid or sour stomach
  • back pain
  • belching
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • cough
  • difficulty with moving
  • dizziness
  • dry mouth
  • flu-like syndrome
  • headache
  • heartburn or indigestion
  • lack or loss of strength or energy
  • muscle pain, stiffness, or weakness
  • nausea
  • pain, swelling, or redness in the joints
  • stomach discomfort, upset, or pain

Some side effects of rimabotulinumtoxinB 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:

For Healthcare Professionals

Applies to rimabotulinumtoxinB: injectable solution

General

The most commonly reported adverse events have included dry mouth, dysphagia, dyspepsia, and injection site pain.[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 34%), dysphagia (up to 25%)
Common (1% to 10%): Dyspepsia, nausea
Frequency not reported: Gastrointestinal disorder, vomiting, glossitis, stomatitis, tooth disorder
Postmarketing reports: Constipation[Ref]

Most case reports of dry mouth or dysphagia were reported as mild or moderate, however, these were the most frequent adverse events resulting in treatment discontinuation. An increased incidence of dysphagia occurred with an increased dose in the sternocleidomastoid muscle; an increasing incidence of dry mouth was associated with dose-related increases in doses injected into the splenius capitis, trapezius, and sternocleidomastoid muscles.

Gastrointestinal disorder, vomiting, glossitis, stomatitis, and tooth disorder were reported in greater than 2% of patients.[Ref]

Respiratory

Common (1% to 10%): Increased cough, rhinitis, dysphonia
Frequency not reported: Dyspnea, lung disorder, pneumonia
Postmarketing reports: Aspiration pneumonia[Ref]

Dyspnea, lung disorder, and pneumonia were reported in greater than 2% of patients.[Ref]

Cardiovascular

Chest pain, vasodilation, peripheral edema, and edema were reported in greater than 2% of patients.[Ref]

Frequency not reported: Peripheral edema, edema, chest pain, vasodilation[Ref]

Local

Very common (10% or more): Injection site pain (up to 15%)[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain
Frequency not reported: Arthritis, joint disorder
Postmarketing reports: Exaggerated muscle weakness[Ref]

Arthritis and joint disorder were reported in greater than 2% of patients.[Ref]

Ocular

Common (1% to 10%): Blurred vision
Postmarketing reports: Abnormal accommodation, ptosis[Ref]

Hypersensitivity

Allergic reaction was reported in greater than 2% of patients.[Ref]

Frequency not reported: Allergic reaction[Ref]

Nervous system

Very common (10% or more): Headache (up to 11%)
Common (1% to 10%): Torticollis, myasthenia, dizziness
Frequency not reported: Migraine, hyperesthesia, somnolence, taste perversion[Ref]

Migraine, hyperesthesia, somnolence, and taste perversion were reported in greater than 2% of patients.[Ref]

Dermatologic

Frequency not reported: Cyst, pruritus, ecchymosis
Postmarketing reports: Angioedema, urticaria, rash[Ref]

Cyst, ecchymosis, and pruritus was reported in greater than 2% of patients.[Ref]

Immunologic

Very common (10% or more): Infection (up to 15%)
Common (1% to 10%): Flu syndrome
Frequency not reported: Viral infection, antibodies against botulinum toxin b[Ref]

Viral infection and antibodies against botulinum toxin b were reported in greater than 2% of patients.[Ref]

Metabolic

Frequency not reported: Hypercholesterolemia[Ref]

Hypercholesterolemia was reported in greater than 2% of patients.[Ref]

Psychiatric

Frequency not reported: Anxiety, confusion[Ref]

Anxiety and confusion were reported in greater than 2% of patients.[Ref]

Other

Very common (10% or more): Neck pain related to cervical dystonia (up to 17%), pain (up to 13%)
Common (1% to 10%): Asthenia, accidental injury
Frequency not reported: Chills, malaise, fever, vertigo, otitis media, tinnitus, tremor[Ref]

Chills, malaise, fever, vertigo, otitis media, tinnitus, tremor were reported in greater than 2% of patients.[Ref]

Genitourinary

Urinary tract infection, cystitis, and vaginal moniliasis were reported in greater than 2% of patients.[Ref]

Frequency not reported: Urinary tract infection, cystitis, vaginal moniliasis[Ref]

Oncologic

Neoplasm was reported in greater than 2% of patients.[Ref]

Frequency not reported: Neoplasm[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Myobloc (botulinum toxin type B)" Elan Pharmaceuticals, S. San Francisco, CA.

Further information

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.

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