Cariprazine-Associated ALT Elevation
Vraylar (cariprazine) can be associated with increased hepatic transaminases, including alanine aminotransferase (ALT) elevations. [1]
Product-Label Evidence for ALT Elevation
The Vraylar prescribing information lists hepatic enzyme increases as adverse reactions, with specific terms including ALT increased and aspartate aminotransferase (AST) increased. [1]
Incidence of Transaminase Elevations in Trials
In 6-week schizophrenia trials, the proportion of patients with transaminase elevations of ≥3 times the upper limit of normal (ULN) was 1% with placebo and 1% to 2% with Vraylar-treated patients. [1]
Clinical Pattern and Severity
ALT and AST elevations associated with cariprazine are categorized within hepatic enzyme increase adverse event terms in the prescribing information. [1]
Postmarketing / Clinical Summary Resources
LiverTox summarizes that cariprazine is associated with aminotransferase elevations and provides clinical context for monitoring in the setting of possible drug-induced liver injury. [2]
Monitoring Implications
ALT elevations are a known possible adverse effect of Vraylar, so ALT should be considered for evaluation when clinically indicated for suspected hepatic injury. [1], [2]
Practical Clinical Approach to Suspected Drug-Related Hepatic Injury
Cariprazine should be evaluated as a potential contributor when ALT rises occur in temporal association with treatment or when elevations meet thresholds used to define clinically significant liver injury in standard clinical practice. [2]