Valbenazine Side Effects
Applies to valbenazine: oral capsule.
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Warning: Depression and Suicidal Ideation and Behavior in Patients with Huntington's DiseaseVMAT2 inhibitors, including valbenazine, can increase the risk of depression and suicidal thoughts and behavior in patients with Huntington's disease.
Anyone considering the use of valbenazine must balance the risks of depression and suicidal ideation and behavior with the clinical need for treatment of chorea.
Closely monitor patients for the emergence or worsening of depression, suicidal ideation, or unusual changes in behavior.
Inform patients, their caregivers, and families of the risk of depression and suicidal ideation and behavior and instruct them to report behaviors of concern promptly to the treating physician.Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in patient's with Huntington's disease.
Common side effects of valbenazine
Some side effects of valbenazine 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
- blurred vision
- decrease in the frequency of urination
- decrease in urine volume
- difficulty having a bowel movement (stool)
- difficulty in passing urine (dribbling)
- dry mouth
- painful urination
- sleepiness or unusual drowsiness
Less common side effects
- fear or nervousness
- headache
- joint pain
- muscle pain or stiffness
- nausea
- trouble sleeping
- vomiting
Serious side effects of valbenazine
Along with its needed effects, valbenazine 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 immediately if any of the following side effects occur while taking valbenazine:
Less common side effects
- absence of or decrease in body movement
- clumsiness or unsteadiness
- dizziness
- drooling
- inability to sit still
- loss of balance control
- need to keep moving
- restlessness
- trembling and shaking of the fingers or hands
- trouble walking
Incidence not known
- difficulty swallowing
- fainting
- high fever
- high or low blood pressure
- hives or welts, itching, or red skin rash
- increased sweating
- irregular heartbeat recurrent
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of balance control
- mask-like face
- seizures
- severe muscle stiffness
- shuffling walk
- slowed movements
- slurred speech
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- tiredness
- trembling and shaking of the fingers and hands
- trouble breathing
- unusually pale skin
For healthcare professionals
Applies to valbenazine: oral capsule.
General adverse events
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
Musculoskeletal
- Common (1% to 10%): Arthralgia[Ref]
Psychiatric
Respiratory
- Common (1% to 10%): Respiratory infections[Ref]
References
1. (2017) "Product Information. Ingrezza (valbenazine)." Neurocrine Biosciences, Inc.
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Further information
Valbenazine 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.