What is the most common side effect of clozapine?

Clozapine can cause a serious blood condition. Your doctor will order certain lab tests before you start your treatment, during your treatment, and for at least 4 weeks after your treatment. Your doctor will order the lab tests once a week at first and may order the tests less often as your treatment continues. If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; weakness; fever, sore throat, chills, or other signs of flu or infection; unusual vaginal discharge or itching; sores in your mouth or throat; wounds that take a long time to heal; pain or burning while urinating; sores or pain in or around your rectal area; or abdominal pain.

Because of the risks with this medication, clozapine is available only through a special restricted distribution program. A program has been set up by the manufacturers of clozapine to be sure that people do not take clozapine without the necessary monitoring called the Clozapine Risk Evaluation and Mitigation Strategies (REMS) Program. Your doctor and your pharmacist must be registered with the Clozapine REMS program, and your pharmacist will not dispense your medication unless he or she has received the results of your blood tests. Ask your doctor for more information about this program and how you will receive your medication.

Clozapine may cause seizures. Tell your doctor if you have or have ever had seizures. Do not drive a car, operate machinery, swim, or climb while taking clozapine, because if you suddenly lose consciousness, you could harm yourself or others. If you experience a seizure, call your doctor immediately or get emergency medical treatment.

Clozapine may cause myocarditis (swelling of the heart muscle that may be dangerous) or cardiomyopathy (enlarged or thickened heart muscle that stops the heart from pumping blood normally). If you experience any of the following symptoms, call your doctor immediately: extreme tiredness; flu like symptoms; difficulty breathing or fast breathing; fever; chest pain; or fast, irregular, or pounding heartbeat.

Clozapine may cause dizziness, lightheadedness, or fainting when you stand up, especially when you first start taking it or when your dose is increased. Tell your doctor if you have or have had a heart attack, heart failure, or a slow, irregular heartbeat or are taking medications for high blood pressure. Also tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment. Your doctor will probably start you on a low dose of clozapine and gradually increase your dose to give your body time to adjust to the medication and decrease the chance that you will experience this side effect. Talk to your doctor if you do not take clozapine for 2 days or longer. Your doctor will probably tell you to restart your treatment with a low dose of clozapine.

Use in Older Adults:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as clozapine have an increased chance of death during treatment.

Clozapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed clozapine if you, a family member, or someone you care for has dementia and is taking this medication. For more information visit the FDA website: http://www.fda.gov/Drugs

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Adverse reactions divided by frequency regarding patients and treatment: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data) (Agenzia Italiana del Farmaco [AIFA] document 06/06/2014)25