What are the potential side effects of Vrayler?

Vraylar (Cariprazine) Side Effects

Vraylar causes several serious and common side effects that require careful monitoring, with the most concerning being late-occurring adverse events that can develop weeks after starting treatment or dose increases due to the drug's prolonged presence in the body. 1

Serious Side Effects Requiring Immediate Medical Attention

Neuroleptic Malignant Syndrome (NMS)

• NMS is a potentially fatal condition characterized by high fever, stiff muscles, confusion, increased sweating, and changes in breathing, heart rate, and blood pressure 1
• Requires immediate emergency medical evaluation if symptoms develop 1

Tardive Dyskinesia

• Uncontrolled movements of the face, tongue, or other body parts that may be permanent even after discontinuing Vraylar 1
• Can also begin after stopping the medication 1

Cerebrovascular Events

• Increased risk of stroke in elderly patients with dementia-related psychosis, which can be fatal 1
• This population should not receive Vraylar 1

Metabolic Side Effects

Hyperglycemia and Diabetes

• Blood sugar monitoring is required before starting treatment, soon after initiation, and regularly during long-term therapy 1
• Extremely high blood sugar can lead to coma or death 1
• Warning signs include excessive thirst, increased urination, extreme hunger, weakness, fatigue, nausea, confusion, or fruity-smelling breath 1

Dyslipidemia

• Cholesterol and triglyceride levels should be checked before starting, soon after initiation, and periodically during treatment 1

Weight Gain

• Weight monitoring is required before starting and frequently during treatment 1

Cardiovascular and Neurological Side Effects

Orthostatic Hypotension

• Lightheadedness or fainting when rising from sitting or lying positions 1
• Contributes to fall risk 1

Falls

• Result from sleepiness, dizziness, orthostatic hypotension, and slowed thinking/motor skills 1
• Can cause fractures or other injuries 1

Seizures

• Convulsions may occur during treatment 1

Hematologic Effects

• Low white blood cell count may develop, requiring blood tests during the first few months of treatment 1

Most Common Side Effects

The following occur frequently but are typically mild to moderate in severity 1, 2, 3:

• Movement disorders: Difficulty moving, slow movements, tremors, uncontrolled body movements (akathisia), restlessness with need to move around 1, 2
• Gastrointestinal: Nausea, vomiting, indigestion, constipation 1
• Central nervous system: Sleepiness, drowsiness, fatigue, difficulty thinking, trouble sleeping 1
• Other: Increased appetite, dizziness 1

Critical Timing Consideration: Late-Occurring Side Effects

Vraylar remains in the body for an extended period, causing a unique risk profile where side effects may not appear immediately 1. Side effects can:

• Start several weeks after initiating treatment 1
• Develop after dose increases 1
• Require healthcare provider monitoring for several weeks following any treatment change 1

Additional Safety Concerns

Temperature Regulation

• Difficulty controlling body temperature, leading to feeling too warm 1
• Avoid overheating and dehydration 1

Dysphagia

• Difficulty swallowing that can cause aspiration of food or liquid into the lungs 1

Cognitive and Motor Impairment

• Sleepiness, drowsiness, and slowed thinking affect ability to perform activities requiring alertness 1
• Patients should avoid driving or operating machinery until they know how Vraylar affects them 1

Extrapyramidal Side Effects

While cariprazine demonstrates efficacy in animal models without extrapyramidal side effects, human studies report extrapyramidal symptoms and akathisia of mild to moderate intensity 2, 3.