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Iloperidone Side Effects

In Summary

Commonly reported side effects of iloperidone include: dizziness, drowsiness, tachycardia, weight gain, sedation, and xerostomia. Other side effects include: death, diarrhea, fatigue, nasal congestion, and orthostatic hypotension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to iloperidone: oral tablet

Along with its needed effects, iloperidone 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
  • Fast, pounding, or irregular heartbeat or pulse
Less common
  • 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
  • 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

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
  • Diarrhea
  • sleepiness or unusual drowsiness
Less common
  • Abdominal or stomach discomfort
  • not able to ejaculate semen
  • rash
  • stuffy nose
Rare
  • 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 kit, oral tablet

General

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

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]

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]

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. "Product Information. Fanapt (iloperidone)." Vanda Pharmaceuticals Inc, Rockville, MD.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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