Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

1. Fanapt
2. Fanapt Titration Pack

Descriptions

Iloperidone is used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of iloperidone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iloperidone in the elderly. However, elderly patients are more likely to have dementia or age-related liver problems, which may require caution in patients receiving iloperidone.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Fluconazole
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Metoclopramide
• Nelfinavir
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acecainide
• Adagrasib
• Ajmaline
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Azimilide
• Azithromycin
• Bedaquiline
• Bretylium
• Buprenorphine
• Buserelin
• Celecoxib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Desvenlafaxine
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Duloxetine
• Efavirenz
• Encorafenib
• Entrectinib
• Erythromycin
• Escitalopram
• Etrasimod
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nefazodone
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Ritonavir
• Selpercatinib
• Sematilide
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tedisamil
• Telavancin
• Telithromycin
• Tetrabenazine
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alzheimer's disease or
• Blood vessel disease or
• Bradycardia (slow heartbeat), severe or
• Dehydration or
• Heart attack, recent or history of, or
• Heart failure, history of or
• Heart rhythm problems (eg, prolonged QT interval), or a history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• Hypotension (low blood pressure) or
• Hypovolemia (low amount of blood) or
• Stroke, history of—May cause side effects to become worse.

• Blood or bone marrow problems or
• Breast cancer, prolactin-dependent or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Hyperprolactinemia (high prolactin in the blood) or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Liver disease, severe—Should not use in patients with this condition.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

You may take this medicine with or without food.

Dosing

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.

• For oral dosage form (tablets):
  • For treatment of schizophrenia:
    • Adults—At first, 1 milligram (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg two times a day (24 mg per day).
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor for instructions if you must stop taking the medicine for more than 3 days.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

1. Fast, pounding, or irregular heartbeat or pulse

Less common

1. Blurred vision
2. body aches or pain
3. chills
4. cold sweats
5. confusion
6. cough
7. difficult or labored breathing
8. difficulty with moving
9. difficulty with speaking
10. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
11. drooling
12. ear congestion
13. fever
14. headache
15. inability to sit still
16. loss of balance control
17. loss of voice
18. muscle pain or stiffness
19. muscle trembling, jerking, or stiffness
20. nasal congestion
21. need to keep moving
22. pain in the joints
23. restlessness
24. runny nose
25. shakiness in the legs, arms, hands, or feet
26. shortness of breath
27. shuffling walk
28. sneezing
29. sore throat
30. stiffness of the limbs
31. sweating
32. tightness in the chest
33. trembling or shaking of the hands or feet
34. twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
35. uncontrolled movements, especially of the face, neck, and back
36. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Rare

1. Abdominal or stomach fullness
2. aching or discomfort in the lower legs or sensation of crawling in the legs
3. actions that are out of control
4. aggressive or angry
5. agitation
6. anxiety
7. attack, assault, or force
8. back pain
9. black, tarry stools
10. bloody nose
11. burning while urinating
12. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
13. chest pain or discomfort
14. coma
15. confusion as to time, place, or person
16. constipation
17. convulsions
18. decrease in the amount of urine
19. decrease in the frequency of urination
20. decrease in urine volume
21. decreased awareness or responsiveness
22. decreased urination
23. decreased weight
24. depression
25. difficult or painful urination
26. difficulty in passing urine (dribbling)
27. difficulty with walking
28. dilated neck veins
29. dizziness
30. dry mouth
31. dry skin and hair
32. extreme thirst
33. extremely high fever or body temperature
34. fainting
35. false beliefs that cannot be changed by facts
36. fast, shallow breathing
37. feeling cold
38. frequent urination
39. gaseous abdominal pain
40. groin pain
41. hair loss
42. hoarseness or husky voice
43. holding false beliefs that cannot be changed by fact
44. hostility
45. inability to move the eyes
46. increased blinking or spasms of the eyelid
47. increased thirst
48. irregular breathing
49. irritability
50. lightheadedness
51. loss of appetite
52. loss of bladder control
53. mimicry of speech or movements
54. mood swings
55. muscle aching or cramping
56. muscle spasms
57. muscle twitching
58. nausea or vomiting
59. nervousness
60. noisy breathing
61. noisy, rattling breathing
62. numbness or tingling in the hands, feet, or lips
63. pale, clammy skin
64. peculiar postures or movements, mannerisms, or grimacing
65. pounding, slow heartbeat
66. rapid breathing
67. rapid weight gain
68. recurrent fever
69. restlessness
70. seizures
71. severe sleepiness
72. slow movement
73. slow reflexes
74. sore throat
75. sore tongue
76. sores, ulcers, or white spots on the lips or in the mouth
77. sticking out of tongue
78. stupor
79. sunken eyes
80. swelling
81. swelling of the face, ankles, fingers, feet, or lower legs
82. swollen glands
83. swollen joints
84. swollen, tender prostate
85. talking, feeling, and acting with excitement
86. thirst
87. troubled breathing at rest
88. troubled breathing with exertion
89. uncontrolled twisting movements of the neck, trunk, arms, or legs
90. unusual bleeding or bruising
91. unusual excitement, nervousness, or restlessness
92. unusual facial expressions
93. weight gain
94. wrinkled skin
95. yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

1. Diarrhea
2. sleepiness or unusual drowsiness

Less common

1. Abdominal or stomach discomfort
2. not able to ejaculate semen
3. rash
4. stuffy nose

Rare

1. Absent, missed, or irregular menstrual periods
2. blindness
3. blurred vision
4. breast pain
5. burning feeling in the chest or stomach
6. burning upper abdominal pain
7. canker sores
8. continuing ringing or buzzing or other unexplained noise in the ears
9. decreased interest in sexual intercourse
10. decreased vision
11. delusions of persecution, mistrust, suspiciousness, or combativeness
12. dry eyes
13. feeling of constant movement of self or surroundings
14. hearing loss
15. inability to have or keep an erection
16. increase in blood flow to the whites of the eyes
17. increased appetite
18. increased watering of the mouth
19. indigestion
20. irregular menstruation
21. irritation or soreness of the mouth
22. longer or heavier menstrual periods
23. loss in sexual ability, desire, drive, or performance
24. loss of bowel control
25. loss of memory
26. normal menstrual bleeding occurring earlier, possibly lasting longer than expected
27. problems with memory
28. redness, swelling, or itching of the eyelids
29. sensation of spinning
30. stomach upset
31. stopping of menstrual bleeding
32. swelling of the breasts or breast soreness in both females and males
33. swelling or inflammation of the mouth
34. tenderness in the stomach area
35. uncontrolled eye movements

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Portions of this document last updated: April 01, 2024

Original article: https://www.mayoclinic.org/drugs-supplements/iloperidone-oral-route/precautions/DRG-20072986