Aristada Warnings

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

• May cause drowsiness and dizziness. Alcohol and marijuana may intensify this effect. Use care when operating a vehicle, vessel (e.g., boat), or machinery.
• Shake well before using.
• Use during the 3rd trimester of pregnancy may cause serious health problems or withdrawal symptoms in the newborn. Discuss with your doctor or pharmacist.
• Do not drink alcoholic beverages when using this medication.
• If you are pregnant or considering becoming pregnant you should discuss the use of this medication with your doctor or pharmacist.
• Read the boxed warning information for this medication.

Lactation Warnings

• LIMITED DATA SUGG SMALL AMOUNTS EXCRETED; CONSIDER MATERNAL TX VS INFANT RISK

Pregnancy Warnings

• Insufficient human data available. Extrapyramidal and/or withdrawal symptoms have been reported in neonates exposed to antipsychotic drugs in the 3rd trimester. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes. Animal data suggest developmental toxicity at doses less than10 times the maximum recommended human dose.