RimabotulinumtoxinB Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 17, 2024.

Applies to rimabotulinumtoxinB: intramuscular solution.

Precautions

It is very important that your doctor check your progress 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.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

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

This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

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:

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:

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]

See also:

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