Aripiprazole side effects and warning (marketed at Abilify)          November 17, 2005
This is a summary of the most important information about Abilify. For details,
talk to your healthcare professional.

FDA ALERT [04/2005] – Abilify is a type of medicine called an atypical
antipsychotic. FDA has found that older patients treated with atypical
antipsychotics for dementia had a higher chance for death than patients who
did not take the medicine. This is not an approved use.

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.


What Is Abilify?
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
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
It is important to avoid overheating and dehydration while taking Abilify. Abilify
may make it harder to lower your body temperature.
Questions? Call Drug Information, 1-888-INFO-FDA (automated) or 301-827-