AND PRECAUTIONS, ADVERSE REACTIONS). ABILIFY should only be prescribed in ABILIFY should only be prescribed in patients with MDD by clinicians who are aware of the importance and are experienced in the Summary of the safety profile: The most frequently observed adverse drug reactions (ADRs) reported in ≥ 5 % of patients in two double-blind controlled clinical trials of Abilify Maintena were weight increased (9.0 %), akathisia (7.9 %), insomnia (5.8 %), and injection site pain (5.1 %). Dose-Related Adverse Reactions In Patients With Schizophrenia. Dose response relationships for the incidence of treatment-emergent adverse events were evaluated from four trials in adult patients with schizophrenia comparing various fixed doses (2, 5, 10, 15, 20, and 30 mg/day) of oral aripiprazole to placebo. Most Commonly Observed Adverse Reactions: The most commonly observed adverse reactions with ABILIFY MAINTENA in patients with schizophrenia (incidence ≥5% and at least twice that for placebo) were increased weight, akathisia, injection site pain, and sedation. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. Because of the potential for serious adverse reactions in nursing infants from ABILIFY, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Frequency not reported: Cerebrovascular adverse reactions, cognitive/motor impairment, dizziness, increased mortality in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, seizures, stroke, tardive dyskinesia How to use Abilify. Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking aripiprazole and each time you get a refill. Contraindications. Abilify Mycite is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis [see Adverse Reactions (6.2)].