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.
If you are using aripiprazole in combination with other medication to treat depression, also carefully read the drug information for the other medication.
See also Warning section.
Before taking aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with blood flow in the brain (such as cerebrovascular disease, stroke), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease, heart failure, irregular heartbeat), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count (including history of low white blood cell count caused by medications), swallowing problems.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Liquid preparations of this product may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about using this product safely.
Older adults may be more sensitive to the side effects of this drug, especially seizures, drowsiness, confusion, tardive dyskinesia, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Drowsiness and confusion can increase the risk of falling.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.
Since untreated mental/mood problems (such as bipolar disorder, schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
See also Warning section.
Dizziness, lightheadedness, drowsiness, nausea, vomiting, tiredness, excess saliva/drooling, blurred vision, weight gain, constipation, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as increased anxiety, depression, suicidal thoughts), trouble swallowing, restlessness (especially in the legs), shaking (tremor), muscle spasm, mask-like expression of the face, seizures, signs of infection (such as fever, persistent sore throat), trouble controlling certain urges (such as gambling and sex).
This medication may rarely make your blood sugar level rise, which can cause or worsen diabetes. Rarely, very serious conditions such as diabetic coma may occur. Tell your doctor right away if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This medication may rarely cause a condition called tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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