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Valbenazine Side Effects

For the Consumer

Applies to valbenazine: oral capsule

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Not able to focus.
  • Blurred eyesight.
  • Trouble passing urine.
  • A type of abnormal heartbeat (prolonged QT interval) can happen with this drug. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Feeling tired or weak.
  • Dry mouth.
  • Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to valbenazine: oral capsule

General

-The most common adverse reaction (5% or more and twice the rate of placebo) was somnolence.
-A total of 3% of patients discontinued treatment because of adverse reactions.[Ref]

Nervous system

Very common (10% or more): Somnolence/fatigue/sedation (10.9%)
Common (1% to 10%): Anticholinergic effects (dry mouth, constipation, attention disturbance, blurred vision, urinary retention), balance disorders/fall/gait disturbance/dizziness, headache, akathisia/restlessness, drooling, dyskinesia,
non-akathisia extrapyramidal symptoms[Ref]

Gastrointestinal

Common (1% to 10%): Vomiting, nausea[Ref]

Hepatic

Common (1% to 10%): Increased alkaline phosphatase and bilirubin[Ref]

Metabolic

Common (1% to 10%): Increased blood glucose, increased weight, increased prolactin[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia[Ref]

Psychiatric

Common (1% to 10%): Anxiety, insomnia[Ref]

Respiratory

Common (1% to 10%): Respiratory infections[Ref]

References

1. "Product Information. Ingrezza (valbenazine)." Neurocrine Biosciences, Inc., San Diego, CA.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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