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Iloperidone Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 7, 2023.

Applies to iloperidone: oral tablet.

Warning

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 Iloperidone

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

Less common

Rare

Other side effects of Iloperidone

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

Less common

Rare

For Healthcare Professionals

Applies to iloperidone: 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

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. Product Information. Fanapt (iloperidone). Vanda Pharmaceuticals Inc. 2009.

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.