What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

agitation anxiety blurred vision constipation coughing dizziness drowsiness dry mouth extrapyramidal symptoms (abnormal body movements, restlessness, shaking, or stiffness) headache heartburn increased saliva

infections of the upper airways lightheadedness nausea or vomiting pain in the joints restlessness runny nose shakiness sore throat suicide swelling of feet or ankles tremors trouble sleeping unusual tiredness or weakness

Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Body temperature: Aripiprazole may interfere with your ability to regulate your body temperature. Take care to avoid overheating during strenuous exercise or in hot temperatures.

Depression: Use of aripiprazole by people with major depressive disorder (MDD) may cause a worsening of the condition and an increase in the risk of suicide. People at high risk of committing suicide should be closely monitored while using aripiprazole.

Diabetes: Aripiprazole may increase blood sugar for people with diabetes. If you have diabetes, monitor your blood sugar frequently as recommended by your doctor.

Drowsiness/reduced alertness: Aripiprazole may cause drowsiness or lightheadedness, which could interfere with your ability to do activities requiring alertness, such as driving a car. Avoid these activities if the medication affects you in this way. Avoid alcohol while taking aripiprazole as it may make you even drowsier.

High blood pressure: This medication may increase your blood pressure. Your doctor may recommend that your blood pressure be monitored while you are using this medication.

Kidney or liver disease: If you have kidney or liver disease, speak to your doctor before taking this medication.

Low blood pressure: Some people taking aripiprazole may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls. If you experience this problem, try getting up more slowly.

Neuroleptic malignant syndrome (NMS): This medication may cause a potentially fatal reaction called neuroleptic malignant syndrome (NMS). If you develop symptoms of NMS, such as muscle stiffness, fever, confusion, sweating, or irregular heartbeat, stop taking this medication and seek immediate medical attention.

Phenylketonuria: Aripiprazole orally disintegrating tablets contain phenylalanine. The 10 mg tablet has 1.12 mg phenylalanine and the 15 mg tablet has 1.68 mg phenylalanine.

Seizures: Seizures have occurred in people taking aripiprazole. People with a history of seizures should be closely monitored by their doctor while taking this medication.

Swallowing problems: People taking aripiprazole may have difficulty swallowing. Seniors and people on other antipsychotic medications should be closely monitored by their doctor for swallowing problems while they are using this medication.

Tardive dyskinesia: People taking this medication may develop tardive dyskinesia, a syndrome of uncontrolled body movements. This syndrome may be irreversible. If you develop uncontrolled or unusual body movements, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if aripiprazole passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established for children less than 10 years of age.

Seniors: Seniors taking this medication for psychosis related to dementia have a higher risk of strokes and death compared to seniors who are not taking the medication. Aripiprazole is not approved or recommended for this purpose.

What other drugs could interact with this medication?

There may be an interaction between aripiprazole and any of the following:

• carbamazepine
• ketoconazole
• other medications that cause drowsiness, such as:
• alcohol antianxiety medications (e.g., lorazepam, diazepam)
• general anesthetics (medications used to put people to sleep before surgery)
• narcotics (e.g., morphine, codeine)
• sedatives (e.g., phenobarbital)
• tricyclic antidepressants (e.g., imipramine)
• quinidine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.