ARISTADA has been evaluated for safety in 1180 adult patients in clinical trials for schizophrenia1


  • In an open-label pharmacokinetic study, adverse reactions associated with the use of ARISTADA® (aripiprazole lauroxil) were similar across the 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months dose groups1

Akathisia onset relative to injection number and study day2

  • Akathisia was the most common adverse reaction—incidence ≥5% and at least twice the rate of placebo in patients treated with ARISTADA in the 12-week clinical trial1
  • 2 out of 415 patients discontinued ARISTADA due to akathisia, which was not dose-related2
  • Benzodiazepines and short-acting beta-blockers were permitted for treatment-emergent akathisia as needed2

Prolactin levels at baseline and last post-baseline visit3

aBaseline prolactin: placebo: 10.1 (men), 28.8 (women); ARISTADA 441 mg monthly: 10.3 (men), 27.1 (women); ARISTADA 882 mg monthly: 10.2 (men), 25.7 (women). Normal prolactin: 4.0 to 15.2 ng/mL (men), 4.8 to 23.3 ng/mL (women).3

  • In the 12-week clinical trial, prolactin levels decreased below baseline measurements starting at day 29 through day 85 in both ARISTADA groups compared with placebo3
  • Baseline prolactin levels may have been affected by previous antipsychotic medication use prior to starting the study2
  • Patients in the clinical trial had previously established tolerability to aripiprazole, which may affect prolactin measurements4


  • In the 12-week clinical trial, mean increase in body weight from baseline to last post-baseline assessment was 0.02 pounds for placebo (n = 207), 1.6 pounds for ARISTADA 441 mg monthly (n = 207), and 1.9 pounds for ARISTADA 882 mg monthly (n = 208)3
  • The percentage of patients with ≥7% increase in weight noted at the last post-baseline visit during the treatment period was 6% for placebo, 10% for ARISTADA 441 mg monthly, and 9% for ARISTADA 882 mg monthly1


  • In the phase 3 clinical trial, overall injection-site reactions (ISRs) were reported in 2% (placebo), 4% (441 mg monthly), and 5% (882 mg monthly) of patients1
    • Of these, the incidence of pain with the first injection was 2%, 3%, and 4%, respectively, and ≤1% with each subsequent injection. Other ISRs (induration, swelling, and redness) were <1%1
  • In an open-label pharmacokinetic study evaluating 441 mg monthly, 882 mg every 6 weeks, and 1064 mg every 2 months, ISRs were similar across the dose groups1


  • In pharmacokinetic studies, the safety profile of ARISTADA INITIO® (aripiprazole lauroxil) was generally consistent with that observed for ARISTADA5
  • The most commonly observed adverse reaction was akathisia in the 12-week clinical trial for ARISTADA1,5
  • A phase 1 study evaluating the safety, tolerability, and pharmacokinetics of the two initiation regimens was conducted (N = 161). In this study, patients received 21 days of oral aripiprazole (15 mg daily dose) and one ARISTADA dose (n = 81) or one injection of ARISTADA INITIO plus a single dose of 30 mg oral aripiprazole and one ARISTADA dose (n = 80). Patients were randomized 1:1:1:1 to receive an ARISTADA dose of either 441 mg or 882 mg6
    • There were 2 cases of akathisia in the 21-day oral aripiprazole arms (2 mild cases)
    • There were 4 cases of akathisia in the ARISTADA INITIO arm (3 mild cases, 1 moderate case)
    • None of the patients experienced serious adverse events or discontinued participation in the trial due to akathisia
  • In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection-site reactions with ARISTADA INITIO were similar to the incidence observed for ARISTADA5

For a full list of adverse events, please refer to the full Prescribing Information for ARISTADA INITIO and ARISTADA.

Learn about the 52-week safety study

See the study
References: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2019. 2. Data on file. Alkermes, Inc. 3. Nasrallah HA, Newcomer JW, Risinger R, et al. Effect of aripiprazole lauroxil on metabolic and endocrine profiles and related safety considerations among patients with acute schizophrenia. J Clin Psychiatry. 2016;77(11):1519-1525. 4. Meltzer HY, Risinger R, Nasrallah HA, et al. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015;76(8):1085-1090. 5. ARISTADA INITIO [package insert]. Waltham, MA: Alkermes, Inc; 2019. 6. Hard ML, Wehr AY, Du Y, Weiden PJ, Walling D, von Moltke L. Pharmacokinetic evaluation of a 1-day treatment initiation option for starting long-acting aripiprazole lauroxil for schizophrenia. J Clin Psychopharmacol. 2018;38(5):435-441.