RimabotulinumtoxinB Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 2, 2024.

Applies to rimabotulinumtoxinB: intramuscular solution.

Important warnings This medicine can cause some serious health issues

Intramuscular route (injectable)

Postmarketing reports indicate that the effects of rimabotulinumtoxinB and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects.

These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties.

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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

Serious side effects of rimabotulinumtoxinB

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 side effects

• difficulty with swallowing
• infection
• neck pain
• uncontrolled twisting movements of the neck

Rare side effects

• difficulty with breathing or speaking
• muscle weakness

Incidence not known

• cough
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• tightness in the chest
• unusual tiredness or weakness

Other side effects of rimabotulinumtoxinB

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 side effects

• 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

Other side effects of rimabotulinumtoxinB

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, intramuscular solution.

General adverse events

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 39%), dysphagia (up to 25%)
• Common (1% to 10%): Dyspepsia, nausea, dental carries
• 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

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

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

Hypersensitivity

• Frequency not reported: Allergic reaction^[Ref]

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

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

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

Oncologic

• Frequency not reported: Neoplasm^[Ref]

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

Frequently asked questions

• What is botulinum toxin used to treat?

Further information

RimabotulinumtoxinB 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