CLINICAL SAFETY PROFILE OF
ABILIFY MAINTENA ® (aripiprazole)
ABILIFY MAINTENA has been evaluated for safety in more than 2,000 adult patients with schizophrenia
Adverse reactions in ≥2% of patients in a 12-week, double-blind, placebo-controlled study
*Table excludes adverse reactions that had an incidence ≤ placebo.
- In an open-label study comparing bioavailability of
ABILIFY MAINTENA administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates
Adverse reactions with an incidence ≥5% of patients and at least twice that for placebo

on ABILIFY MAINTENA or placebo discontinued due to these 4 adverse reactions
In a 12-week study, 4.2% of patients on ABILIFY MAINTENA discontinued due to all adverse reactions vs 7.6% with placebo1
The following safety information is derived from a 12-week, double-blind study in patients with schizophrenia
Prolactin and extrapyramidal symptoms (EPS) in schizophrenia
†
‡Incidence for
N=number of patients treated; n=number of patients with event; SD=standard deviation.
Metabolic safety profile in schizophrenia
HDL=high-density lipoprotein; LDL=low-density lipoprotein.
ABILIFY MAINTENA has been evaluated for safety in multiple studies in more than 800 adult patients with bipolar I disorder
The following safety information was derived from a 52-week, open-label study in patients with bipolar I disorder initiated on
Metabolic safety profile in bipolar I disorder
This safety data is from those patients who were initiated on
- In those patients who initiated
ABILIFY MAINTENA , 1.8% discontinuedABILIFY MAINTENA treatment due to weight increase ABILIFY MAINTENA was associated with mean increase in weight from baseline of 1.0 kg at Week 52- 21.4% of these patients demonstrated a ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight
Important Warning and Precaution Regarding Metabolic Changes:
Atypical antipsychotic drugs have caused metabolic changes including:
- Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the
suspect drug . - Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
- Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING.
References: 1. Kane JM, Peters-Strickland T, Baker RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260. 2. Data on file. ABIMAI‑124.