Ross is a writer for Verywell with years of experience practicing pharmacy in various settings. She is also a board-certified clinical pharmacist and the founder of Off Script Consults.
Femi Aremu, PharmD, is a professional pharmacist with experience in clinical and community pharmacy. He currently practices in Chicago, Illinois.
The Food and Drug Administration (FDA) assigned a black box warning to Fanapt (Iloperidone). This medication isn't FDA approved for dementia-related psychosis. In older adults over 65 years of age, Fanapt raises the risk of death if taken for dementia-related psychosis.
Fanapt (iloperidone) is a treatment option for schizophrenia. Fanapt is considered a second-generation, or atypical, antipsychotic. It's thought to work by interfering with the activity of dopamine and serotonin. Dopamine and serotonin are naturally occurring chemicals in the brain.
Fanapt is available as prescription tablets.
Brand Name(s): Fanapt
Therapeutic Classification: Second-generation, or atypical, antipsychotic
Available Generically: FDA approved but not yet available
Administration Route: Oral (by mouth)
Dosage Form(s): Tablet
Fanapt is used for schizophrenia.
It's unknown exactly how common schizophrenia is, but it's estimated that 0.25% to 0.64% of the U.S. population likely has schizophrenia or similar mental health conditions.
The age of onset for schizophrenia is usually between the teenage years and early 30s—with earlier onset (start) in people assigned male at birth and later onset in people assigned female at birth.
Some symptoms of schizophrenia may include:
Take Fanapt by mouth twice daily with or without food.
When you receive Fanapt from the pharmacy, store the medication at room temperature (about 77 degrees Fahrenheit)—with a short-term safety storage range between 59 degrees to 86 degrees. Fanapt should also be protected from light and moisture.
To be safe, keep your medication in a locked cabinet or closet and out of the reach of children and pets.
If you plan to travel with Fanapt, become familiar with your final destination's regulations, such as by checking with the U.S. embassy or consulate. Make a copy of your Fanapt prescription to take with you. Keep your medication in its original pharmacy container, with your name on the label. Consult with your pharmacist or healthcare provider if you have any questions about traveling with your medicine.
You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The FDA's website is a helpful resource regarding where and how to discard of all unused and expired drugs. You can also find disposal boxes in your area.
When you start taking Fanapt, your healthcare provider will need to slowly increase your dosage to prevent side effects. As a result, improvement in your symptoms might be delayed until after you received one to two weeks of treatment with Fanapt. Afterward, Fanapt might require up to two to three months for maximum effectiveness.
Fanapt currently has no off-label uses. "Off-label" means using the medication for a condition it was not FDA approved for but that may help treat it.
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Common side effects with Fanapt may include:
Get medical help right away if you develop the following serious side effects:
Call 911 if your symptoms or symptoms of a loved on on Fanapt feel life-threatening.
Possible long-term side effects with Fanapt may include:
Fanapt may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
The following modifications (changes) should be kept in mind when using Fanapt:
Severe allergic reaction: Avoid using Fanapt if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.
Pregnancy: In animal studies, Fanapt was found to have negative effects on the fetus. Taking Fanapt during the third trimester in humans was also linked to reports of extrapyramidal (muscle movement) effects and withdrawal (discontinuation) symptoms in newborns. Be aware of symptoms such as agitation, breathing troubles, feeding problems, tremors, or abnormal muscle tone. Symptom severity will vary per newborn.
Consider enrolling in the National Pregnancy Registry for Atypical Antipsychotics online or by calling 866-961-2388. Also, discuss with your healthcare provider if you plan to become pregnant or are pregnant. Your healthcare provider will help you weigh the benefits and risks of taking Fanapt during pregnancy.
Breastfeeding: In animal studies, Fanapt was present in breast milk. Not enough is known about the effects and safety of Fanapt in human breast milk and nursing babies. Therefore, Fanapt typically is not recommended while breastfeeding. Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider will help you weigh the benefits and harms of taking Fanapt while nursing. They can also discuss the different ways available to feed your baby.
Older adults over 65 years: Clinical studies haven't included a large enough number of people in this age group to determine whether they respond differently from younger adults. However, in older adults with dementia-related psychosis, Fanapt might increase the likelihood of death.
Children: There is little information about the effectiveness and safety of Fanapt in children.
Liver problems: The liver is usually responsible for clearing out medications from your body. If your liver isn't working as well, medications like Fanapt might build up in the body and cause side effects.
For mild liver impairment, dosage adjustments aren't necessary. But your healthcare provider may change your Fanapt dosage for moderate liver impairment. Fanapt hasn't been studied in people with severe liver impairment. As a result, the medication isn't recommended if you fall into this group.
If you accidentally forget your Fanapt dose, take it as soon as you remember. If it's already close to your next scheduled dose, then skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.
Try to find ways that work for you to help yourself remember to keep your appointments and take your medication routinely. If you miss too many doses, you might experience a relapse or worsening symptoms. If you miss more than three days of doses, reach out to your healthcare provider. They may need to start you on a lower Fanapt dose and slowly increase the dosage again.
An overdose of Fanapt tends to exaggerate the common side effects of this medication. Some symptoms of a suspected overdose may include:
If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
If you think you or someone else may have overdosed on Fanapt, call a healthcare provider or the Poison Control Center (800-222-1222).
If someone collapses or isn't breathing after taking Fanapt, call 911 immediately.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.
This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.
Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.
This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
Iloperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.
Iloperidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.
Avoid drinking alcohol while you are using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Before taking Fanapt, talk with your healthcare provider if any of the following applies to you:
When taking Fanapt, use caution with medications—like a heart medication called Pacerone or Cordarone (amiodarone)—that have a side effect of abnormal heart rhythms. Also, be careful with blood pressure medications, such as Benicar (olmesartan). Fanapt may cause abnormal heart rhythm and low blood pressure. Therefore, combining Fanapt with other medicines with similar side effects may worsen these side effects.
Caution should also be used with CYP2D6 and CYP3A4 inhibitors. CYP2D6 and CYP3A4 are part of the liver's cytochrome P450 (CYP450) family of proteins. These proteins are responsible for breaking down medications—like Fanapt. Medicines that inhibit CYP2D6 or CYP3A4 prevent these proteins from working as well. Therefore, Fanapt might build up in the body, resulting in more side effects. A typical example of a CYP2D6 inhibitor is Paxil (paroxetine) for depression, and an example of a CYP3A4 inhibitor is the ketoconazole antifungal.
Since Fanapt affects the central nervous system (CNS), be careful with other medications that also affect the CNS, which includes the brain and spinal cord. Alcohol also should be avoided.
Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Fanapt.
And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.
Fanapt (iloperidone) is a second-generation, or atypical, antipsychotic. Other similar antipsychotics may are:
While all of these are antipsychotics, multiple antipsychotics have been used together for schizophrenia.
Fanapt is available as a prescription from your healthcare provider. Your local retail pharmacy may carry Fanapt. If they don't have Fanapt in stock, the pharmacy staff may need to order the medication for you.
Fanapt isn't available as a generic yet. Therefore, this medication might be expensive.
If cost is a concern, consider the following potential helpful resources: NeedyMeds, Simplefill, BenefitsCheckUp, Medicare Rights Center, State Pharmaceutical Assistance Programs (SPAPs), Rx Outreach, or FundFinder.
The number of antipsychotics varies by person. Some people will have symptom relief with just one medication. Some people may require more than one medication to experience symptom control.
Schizophrenia is a lifelong medical condition that doesn't currently have a cure. Therefore, you'll likely take the medications that work for you long term.
If you're taking Fanapt, chances are schizophrenia has impacted your quality of life. Living with schizophrenia can have its challenges. You may have tried different approaches or treatments. The following are suggestions to support your health:
Verywell Health's drug information is meant for educational purposes only and is not intended to replace medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.
Food and Drug Administration. Fanapt label.
National Institute of Mental Health. Schizophrenia.
National Alliance on Mental Illness. Iloperidone (Fanapt).
Food and Drug Administration. Drug development and drug interactions | table of substrates, inhibitors and inducers.
Huhn M, Nikolakopoulou A, Schneider-Thoma J, et al. Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis. The Lancet. 2019;394(10202):939-951. doi: https://doi.org/10.1016/S0140-6736(19)31135-3
Tiihonen J, Taipale H, Mehtala J, et al. Association of antipsychotic polypharmacy vs monotherapy with psychiatric rehospitalization among adults with schizophrenia. JAMA Psychiatry. 2019;76(5):499-507. doi: https://doi.org/10.1001/jamapsychiatry.2018.4320
American Psychiatric Association. What is schizophrenia?.
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