This is a summary of the most important information about Abilify. For details, talk to your healthcare professional

FDA has asked the companies that make these medicines to change their labels to include this important information.

This information reflects FDA’s current analysis of all available data concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

Abilify is in a class of medications called atypical antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia that may include hearing voices, seeing things, or sensing things that are not there, mistaken beliefs or unusual suspiciousness.

Abilify is used to treat mixed or manic episodes in adults who have a condition called Bipolar I disorder. Bipolar disorder is a mental illness than causes extreme mood swings.

What Are The Risks?

The following are the major potential risks and side effects of Abilify therapy. However, this list is not complete.

Abilify and other antipsychotic medications can cause serious problems such as:

A life-threatening nervous system problem called neuroleptic malignant syndrome (NMS). NMS can cause a high fever, stiff muscles, sweating, a fast or irregular heart beat, change in blood pressure, and confusion. NMS can affect your kidneys. NMS is a medical emergency. Call your healthcare professional right away if you experience these symptoms.
A movement problem called tardive dyskinesia (TD). Call your healthcare professional right away if you get muscle movements that cannot be stopped.
High blood sugar and diabetes. Patients with diabetes or who have a higher chance for diabetes should have their blood sugar checked often.
Strokes have happened in older patients treated for mental illness from dementia. Abilify is not approved for this use. See FDA Alert.
Other serious side effects with Abilify may include low blood pressure seen as dizziness, increased heart beat and possibly fainting; seizures; increased body temperature; and difficulty swallowing.
The most common side effects may include headache, weakness, nausea, vomiting, constipation, anxiety, problems sleeping, lightheadedness (dizziness), sleepiness, restlessness and rash.

What Should I Tell My Healthcare Professional?

Before you start taking Abilify, tell your healthcare professional if you:

• have or had heart problems
• have or had seizures
• have or had diabetes or increased blood sugar
  are trying to become pregnant, are already pregnant, or are breast-feeding.
• drink alcohol
  
  Are There Any Interactions With Drugs or Foods?

Because certain other medications can interact with Abilify review all medications that you are taking with your healthcare professional, including those that you take without a prescription.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following:

• blood pressure medicines
• ketoconazole
• quinidine
• carbamazepine
• fluoxetine or paroxetine
• Avoid drinking alcohol while taking Abilify.

Is There Anything Else I Need to Know?

Abilify may impair judgment, thinking, or motor skills. You should be careful in operating machinery, including automobiles, until you know how Abilify affects you.

It is important to avoid overheating and dehydration while taking Abilify. Abilify may make it harder to lower your body temperature.