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To report SUSPECTED ADVERSE REACTIONS, contact Alkermes, Inc. at 1-866-274-7823 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
ARISTADA® (aripiprazole lauroxil) is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia. It is not known if ARISTADA is safe and effective in children under 18 years of age.
Contraindication: Do not receive ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.
ARISTADA may cause serious side effects including:
The most common side effect of ARISTADA includes feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia). These are not all the possible side effects of ARISTADA. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
Do not drive, operate machinery, or do other dangerous activities until you know how ARISTADA affects you. ARISTADA may make you feel drowsy.
Do not drink alcohol while you receive ARISTADA.
Before receiving ARISTADA tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines while receiving ARISTADA without talking to your healthcare provider first.
If you have any questions about your health or medicines, talk to your healthcare provider.
You are encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.