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Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of aripiprazole in children with schizophrenia below 13 years of age and in children with bipolar disorder below 10 years of age. Safety and efficacy have not been established in these age groups.
Aripiprazole is not approved for use in children or teenagers with major depression.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aripiprazole in elderly patients who have schizophrenia, depression, or bipolar disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Metoclopramide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Carbamazepine
- Ketoconazole
- Quinidine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Diabetes, or family history of or
- Drug abuse or dependence, history of or
- Neuroleptic malignant syndrome (NMS), history of or
- Seizures, history of—May make these conditions worse and cause serious side effects.
- Alzheimer's disease or
- Dementia—Should not be used in patients with these conditions.
- Aspiration pneumonia, risk or history of—Use with caution. May increase risk of side effects.
- Blood vessel disease or
- Dehydration or
- Heart disease or
- Heart failure or
- Heart rhythm problems or
- Hypotension (low blood pressure) or
- Hypovolemia (decrease in blood volume) or
- Ischemic heart disease, history of or
- Myocardial infarction (heart attack), history of—Risk of hypotension is increased with this medicine, which can make these conditions worse.
- Exposure to extreme heat or
- Strenuous exercise—May increase the risk of heat stroke because aripiprazole changes the body's ability to cool itself.
- Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.
