Generic Name: iloperidone (EYE-loe-PER-i-done)
Brand Name: Fanapt

Fanapt is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Fanapt is not approved to treat mental problems caused by dementia.


Fanapt is used for:

Treating schizophrenia in adults. It may also be used for other conditions as determined by your doctor.

Fanapt is an atypical antipsychotic. Exactly how it works is not known. It is thought to affect certain substances in the brain.

Do NOT use Fanapt if:

  • you are allergic to any ingredient in Fanapt
  • you have a history of certain heart problems (eg irregular heartbeat, long QT syndrome, a recent heart attack), or you have liver problems
  • you are taking certain antiarrhythmics (eg, amiodarone, procainamide, quinidine, sotalol), methadone, pentamidine, a phenothiazine (eg, chlorpromazine, thioridazine), certain quinolones (eg, gatifloxacin, moxifloxacin), or another medicine that may affect the heartbeat

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Fanapt:

Some medical conditions may interact with Fanapt. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, heart problems (eg, heart failure, slow heartbeat), an abnormal electrocardiogram (ECG), a heart attack, a stroke, blood vessel problems, or high or low blood pressure
  • if you have a history of kidney problems, neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence
  • if you have diabetes or are very overweight, or if a family member has had diabetes
  • if you have low blood potassium or magnesium levels, low white blood cell levels, Alzheimer disease, dementia, Parkinson disease, diarrhea, or esophagus problems (eg, trouble swallowing)
  • if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer
  • if you are dehydrated, drink alcohol, will be exposed to high temperatures, or if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with Fanapt. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain antiarrhythmics, (eg, amiodarone, procainamide, quinidine, sotalol), methadone, pentamidine, phenothiazines, (eg, chlorpromazine,thioridazine), certain quinolones (eg, gatifloxacin, moxifloxacin), or other medicines that affect the heartbeat because the risk of irregular heartbeat may be increased. Check with your doctor if you have questions about which medicines may affect your heartbeat
  • Clarithromycin, itraconazole, ketoconazole, or certain serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), because they may increase the risk of Fanapt's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fanapt may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fanapt:

Use Fanapt as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Fanapt by mouth with or without food.
  • Taking Fanapt at the same time each day will help you remember to take it.
  • Continue to take Fanapt even if you feel well. Do not miss any doses.
  • If you miss a dose of Fanapt, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss your dose of Fanapt for more than 3 days in a row, contact your doctor before you start taking Fanapt again.

Ask your health care provider any questions you may have about how to use Fanapt.

Important safety information:

  • Fanapt may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Fanapt with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Fanapt.
  • Do not use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Fanapt without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or use Fanapt for longer than prescribed without checking with your doctor.
  • Fanapt may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Fanapt may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • NMS is a possibly fatal syndrome that can be caused by Fanapt. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take Fanapt may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Fanapt in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Fanapt.
  • Fanapt may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Fanapt may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Lab tests, including complete blood cell counts, blood electrolyte levels, and fasting blood sugar levels, may be performed while you use Fanapt. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Fanapt with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscles movements.
  • Fanapt should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Fanapt while you are pregnant. Taking Fanapt during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Fanapt is found in breast milk. Do not breast-feed while you are taking Fanapt.

Possible side effects of Fanapt:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; drowsiness; dry mouth; fatigue; nausea; stuffy nose; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; behavior changes; chest pain; confusion; decreased sexual ability; decreased urination; enlarged breasts; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; increased saliva production or drooling; increased sweating; mental or mood changes; missed menstrual period; muscle pain, weakness, or stiffness; nipple discharge; prolonged, painful erection; seizures; severe or prolonged dizziness or headache; shortness of breath; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual eye movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or irregular heartbeat; loss of consciousness; seizures; severe drowsiness or dizziness; stiffness of the face, limbs, or neck; trouble walking; unusual muscle movements.

Proper storage of Fanapt:

Store Fanapt at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fanapt out of the reach of children and away from pets.

General information:

  • If you have any questions about Fanapt, please talk with your doctor, pharmacist, or other health care provider.
  • Fanapt is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Fanapt or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Fanapt. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Fanapt. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Fanapt.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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