Fanapt Side Effects
Generic name: iloperidone
Medically reviewed by Drugs.com. Last updated on Mar 22, 2024.
Note: This document provides detailed information about Fanapt Side Effects associated with iloperidone. Some dosage forms listed on this page may not apply specifically to the brand name Fanapt.
Applies to iloperidone: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death.
Iloperidone is not approved for use in patients with dementia-related psychosis.
Serious side effects of Fanapt
Along with its needed effects, iloperidone (the active ingredient contained in Fanapt) 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 while taking iloperidone:
More common side effects
- fast, pounding, or irregular heartbeat or pulse
Less common side effects
- blurred vision
- body aches or pain
- chills
- cold sweats
- confusion
- cough
- difficult or labored breathing
- difficulty with moving
- difficulty with speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drooling
- ear congestion
- fever
- headache
- inability to sit still
- loss of balance control
- loss of voice
- muscle pain or stiffness
- muscle trembling, jerking, or stiffness
- nasal congestion
- need to keep moving
- pain in the joints
- restlessness
- runny nose
- shakiness in the legs, arms, hands, or feet
- shortness of breath
- shuffling walk
- sneezing
- sore throat
- stiffness of the limbs
- sweating
- tightness in the chest
- trembling or shaking of the hands or feet
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- uncontrolled movements, especially of the face, neck, and back
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Rare side effects
- abdominal or stomach fullness
- aching or discomfort in the lower legs or sensation of crawling in the legs
- actions that are out of control
- aggressive or angry
- agitation
- anxiety
- attack, assault, or force
- back pain
- black, tarry stools
- bloody nose
- burning while urinating
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- coma
- confusion as to time, place, or person
- constipation
- convulsions
- decrease in the amount of urine
- decrease in the frequency of urination
- decrease in urine volume
- decreased awareness or responsiveness
- decreased urination
- decreased weight
- depression
- difficult or painful urination
- difficulty in passing urine (dribbling)
- difficulty with walking
- dilated neck veins
- dizziness
- dry mouth
- dry skin and hair
- extreme thirst
- extremely high fever or body temperature
- fainting
- false beliefs that cannot be changed by facts
- fast, shallow breathing
- feeling cold
- frequent urination
- gaseous abdominal pain
- groin pain
- hair loss
- hoarseness or husky voice
- holding false beliefs that cannot be changed by fact
- hostility
- inability to move the eyes
- increased blinking or spasms of the eyelid
- increased thirst
- irregular breathing
- irritability
- lightheadedness
- loss of appetite
- loss of bladder control
- mimicry of speech or movements
- mood swings
- muscle aching or cramping
- muscle spasms
- muscle twitching
- nausea or vomiting
- nervousness
- noisy breathing
- noisy, rattling breathing
- numbness or tingling in the hands, feet, or lips
- pale, clammy skin
- peculiar postures or movements, mannerisms, or grimacing
- pounding, slow heartbeat
- rapid breathing
- rapid weight gain
- recurrent fever
- restlessness
- seizures
- severe sleepiness
- slow movement
- slow reflexes
- sore throat
- sore tongue
- sores, ulcers, or white spots on the lips or in the mouth
- sticking out of tongue
- stupor
- sunken eyes
- swelling
- swelling of the face, ankles, fingers, feet, or lower legs
- swollen glands
- swollen joints
- swollen, tender prostate
- talking, feeling, and acting with excitement
- thirst
- troubled breathing at rest
- troubled breathing with exertion
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual facial expressions
- weight gain
- wrinkled skin
- yellow eyes or skin
Other side effects of Fanapt
Some side effects of iloperidone 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 side effects
- diarrhea
- sleepiness or unusual drowsiness
Less common side effects
- abdominal or stomach discomfort
- not able to ejaculate semen
- rash
- stuffy nose
Rare side effects
- absent, missed, or irregular menstrual periods
- blindness
- blurred vision
- breast pain
- burning feeling in the chest or stomach
- burning upper abdominal pain
- canker sores
- continuing ringing or buzzing or other unexplained noise in the ears
- decreased interest in sexual intercourse
- decreased vision
- delusions of persecution, mistrust, suspiciousness, or combativeness
- dry eyes
- feeling of constant movement of self or surroundings
- hearing loss
- inability to have or keep an erection
- increase in blood flow to the whites of the eyes
- increased appetite
- increased watering of the mouth
- indigestion
- irregular menstruation
- irritation or soreness of the mouth
- longer or heavier menstrual periods
- loss in sexual ability, desire, drive, or performance
- loss of bowel control
- loss of memory
- normal menstrual bleeding occurring earlier, possibly lasting longer than expected
- problems with memory
- redness, swelling, or itching of the eyelids
- sensation of spinning
- stomach upset
- stopping of menstrual bleeding
- swelling of the breasts or breast soreness in both females and males
- swelling or inflammation of the mouth
- tenderness in the stomach area
- uncontrolled eye movements
For healthcare professionals
Applies to iloperidone: oral tablet.
General adverse events
The most commonly reported side effects included dizziness, somnolence, and tachycardia.[Ref]
Nervous system
- Very common (10% or more): Dizziness (up to 20%), somnolence (up to 15%)
- Common (1% to 10%): Akathisia, dyskinesia, dystonia, extrapyramidal disorder, lethargy, tremor
- Uncommon (0.1% to 1%): Amnesia, bradykinesia, difficulty in walking, nystagmus, paresthesia, parkinsonism, psychomotor hyperactivity, vertigo
- Rare (0.01% to 0.1%): Restless legs syndrome[Ref]
Cardiovascular
- Very common (10% or more): Tachycardia (up to 12%)
- Common (1% to 10%): Hypotension, orthostatic hypotension, palpitations
- Uncommon (0.1% to 1%): Edema due to cardiac disease, general edema, pitting edema
- Rare (0.01% to 0.1%): Acute cardiac failure, arrhythmia, congestive cardiac failure, first degree atrioventricular block[Ref]
In an open-label QTc study of 160 patients with schizophrenia or schizoaffective disorder, use of 12 mg twice a day was associated with a QT prolongation of 9 msec. When this drug was administered concomitantly with paroxetine 20 mg once a day (CYP450 2D6-inhibitor) or ketoconazole 200 mg twice a day (CYP450 3A4-inhibitor), the mean QTc interval prolongation from baseline increased to 19 msec.[Ref]
Gastrointestinal
- Very common (10% or more): Dry mouth (up to 10%), nausea (up to 10%)
- Common (1% to 10%): Abdominal discomfort, diarrhea
- Uncommon (0.1% to 1%): Fecal incontinence, gastritis, mouth ulceration, salivary hypersecretion
- Rare (0.01% to 0.1%): Aphthous stomatitis, duodenal hernia, hiatus hernia, hyperchlorhydria, lip ulceration, reflux esophagitis, stomatitis
- Postmarketing reports: Lip swelling, mouth swelling, oropharyngeal swelling, tongue swelling[Ref]
Respiratory
- Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis, upper respiratory tract infection
- Uncommon (0.1% to 1%): Asthma, epistaxis, nasal dryness, rhinorrhea, sinus congestion
- Rare (0.01% to 0.1%): Dry throat, exertional dyspnea, sleep apnea syndrome
- Postmarketing reports: Throat swelling[Ref]
Psychiatric
- Common (1% to 10%): Aggression, delusion, restlessness
- Uncommon (0.1% to 1%): Anorgasmia, bulimia nervosa, catatonia, confusional state, delirium, hostility, impulse-control disorder, libido decreased, major depression, mania, mood swings, obsessive-compulsive disorder, panic attack, paranoia[Ref]
Ocular
- Common (1% to 10%): Allergic conjunctivitis, blurred vision, conjunctivitis
- Uncommon (0.1% to 1%): Blepharitis, cataract, conjunctival hyperemia, dry eye, eyelid edema, eye swelling, hyperemia, lenticular opacities[Ref]
Genitourinary
- Common (1% to 10%): Ejaculation failure, erectile dysfunction, urinary incontinence
- Uncommon (0.1% to 1%): Amenorrhea, breast pain, dysuria, enuresis, pollakiuria, testicular pain
- Rare (0.01% to 0.1%): Menorrhagia, metrorrhagia, menstruation irregular, postmenopausal hemorrhage, prostatitis, urinary retention
- Postmarketing reports: Retrograde ejaculation[Ref]
Musculoskeletal
- Common (1% to 10%): Muscle spasms, musculoskeletal stiffness, myalgia
- Rare (0.01% to 0.1%): Torticollis[Ref]
Metabolic
- Common (1% to 10%): Weight decreased, weight increased
- Uncommon (0.1% to 1%): Dehydration, fluid retention, hypokalemia, increased appetite, polydipsia psychogenic, thirst[Ref]
Other
- Common (1% to 10%): Fatigue
- Uncommon (0.1% to 1%): Hyperthermia, tinnitus[Ref]
Renal
- Uncommon (0.1% to 1%): Nephrolithiasis
- Rare (0.01% to 0.1%): Acute renal failure[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Postmarketing reports: Facial swelling, pruritus, urticaria[Ref]
Hematologic
- Uncommon (0.1% to 1%): Anemia, hematocrit decreased/lowered, hemoglobin decreased, iron deficiency anemia, neutrophil count increased
- Rare (0.01% to 0.1%): Leukopenia[Ref]
Endocrine
- Uncommon (0.1% to 1%): Hypothyroidism
- Rare (0.01% to 0.1%): Gynecomastia[Ref]
Hepatic
- Uncommon (0.1% to 1%): Cholelithiasis[Ref]
Hypersensitivity
- Postmarketing reports: Anaphylaxis, angioedema, hypersensitivity reactions[Ref]
References
1. (2009) "Product Information. Fanapt (iloperidone)." Vanda Pharmaceuticals Inc
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Further information
Fanapt side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.