Abilify warnings, side effects, and patient safety information

WARNINGS

• Long-term use of aripiprazole may lead to a potentially irreversible condition called tardive dyskinesia (involuntary movements of the jaw, lips, and tongue).
• A potentially fatal complex referred to as neuroleptic malignant syndrome has been reported with anti-psychotic drugs, including Abilify. Patients who develop this syndrome may have:
  • High fevers
  • Muscle rigidity
  • Altered mental status
  • Irregular pulse or blood pressure
  • Rapid heart rate
  • Excessive sweating
  • Heart arrhythmias
• All atypical antipsychotic drugs have been associated with metabolic changes such as hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Serious cases of hyperglycemia leading to coma or death have been reported in patients treated with atypical antipsychotics. Although there is no clear link between aripiprazole and diabetes, patients should be tested during treatment for elevated blood-sugars. Additionally, patients with risk factors for diabetes, including obesity or a family history of diabetes, should have their fasting levels of blood sugar tested before starting treatment and periodically throughout treatment to detect the onset of diabetes. Any patient developing symptoms that suggest diabetes during medical treatment should be tested for diabetes.
• Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death and Abilify should not be used for this indication. Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of this medicine or any other antidepressant in a child or adolescent must balance this risk of suicide with the clinical need. Patients who are started on medical therapy should be closely observed for clinical worsening, suicidal thoughts, or unusual changes in behavior.

Some of the most common side effects include:

• Anxiety
• Blurred vision
• Constipation
• Cough
• Headache
• Insomnia
• Lightheadedness
• Nausea
• Rash
• Restlessness
• Runny nose
• Sleepiness
• Tremors
• Vomiting
• Weakness
• Weight gain

What is the dosage for Abilify?

• This dose for this medication usually is once a day.
• The usual adult starting oral dose for patients with schizophrenia or bipolar disorder is 10 to 15 mg once daily. The dose may be increased over time up to 30 mg daily to achieve the desired effect.
• The recommended dose for patients with Tourette's disorder is 5 to 20 mg once daily.

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.