Cardiovascular Risk Brochure

Important Safety Information

Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). GEODON is not approved for treating these patients.

You should not take GEODON if you have certain kinds of heart conditions or take certain medicines. GEODON may increase the risk of changes to your heart rhythm. It is important to talk to your doctor about this possible side effect. And be sure to call your doctor right away if you faint, pass out, or feel a change in your heartbeat.

Serious side effects can occur with any antipsychotic medicine, including GEODON. Tell your doctor right away if you experience a high fever, stiff muscles, shaking, confusion, sweating, or increased heart rate or blood pressure. These can be signs of a rare condition called neuroleptic malignant syndrome (NMS).

Also tell your doctor if you experience abnormal or uncontrollable facial or body movements. These could be a sign of tardive dyskinesia (TD), which may become permanent.

Medicines like GEODON may raise blood sugar levels. There have been few reports of high blood sugar or diabetes in patients who take GEODON. It is not known if GEODON was the cause.

If you experience a rash, lightheadedness, or seizures while taking GEODON, tell your doctor.

The most common side effects for patients taking GEODON for bipolar mania include sleepiness, abnormal muscle movements (such as tremors, shuffling, and uncontrolled movement), dizziness, and restlessness.

The most common side effects for patients taking GEODON for schizophrenia include sleepiness, increased cough, and runny nose.

In short-term schizophrenia clinical trials, 10% of GEODON-treated patients experienced a weight gain of ≥7% of body weight vs. 4% for placebo.