For the Consumer
Applies to iloperidone: oral kit, oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking iloperidone (the active ingredient contained in Fanapt) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking this medication and call your doctor at once if you have a serious side effect such as:
headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
thoughts about suicide or hurting yourself;
fever, chills, body aches, flu symptoms, sores in your mouth and throat;
urinating less than usual or not at all;
trouble swallowing; or
penis erection that is painful or lasts 4 hours or longer.
Less serious side effects of iloperidone may include:
dizziness, drowsiness, tired feeling;
dry mouth, stuffy nose;
breast swelling or discharge;
weight gain; or
changes in menstrual periods.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to iloperidone: oral kit, oral tablet
Extrapyramidal symptoms have included akathisia (up to 2.3%), bradykinesia (up to 0.6%), dyskinesia (up to 1.7%), dystonia (up to 1%), Parkinsonism (up to 0.3%), and tremor (up to 3.1%).
Nervous system side effects including dizziness (up to 20%), somnolence (up to 15%), extrapyramidal disorder (up to 5%), tremor (3%), and lethargy (up to 3%) have been reported. Paraesthesia, psychomotor hyperactivity, restlessness, amnesia, and nystagmus have been reported infrequently. Restless legs syndrome has been reported rarely.
Cardiovascular side effects including tachycardia (up to 12%), orthostatic hypotension (5%), and hypotension (3%) have been reported. Palpitations have been reported frequently. Arrhythmia, first degree atrioventricular block, cardiac failure (including both congestive and acute) have been reported rarely.
Gastrointestinal side effects including nausea (up to 10%), dry mouth (up to 10%), and abdominal discomfort (up to 3%) have been reported. Gastritis, salivary hypersecretion, fecal incontinence, and mouth ulceration have been reported infrequently. Aphthous stomatitis, duodenal ulcer, hiatus hernia, hyperchlorhydria, lip ulceration, reflux esophagitis, and stomatitis have been reported rarely.
General side effects including increased weight (up to 9%), fatigue (up to 6%), and arthralgia (3%) and have been reported. Decreased weight has been reported frequently. Edema, increased appetite, difficulty in walking, and thirst have been reported infrequently. Hyperthermia has been reported rarely.
Respiratory side effects including nasal congestion (up to 8%), nasopharyngitis (up to 4%), upper respiratory tract infection (up to 3%), and dyspnea (2%) have been reported. Epistaxis, asthma, rhinorrhea, sinus congestion, and nasal dryness have been reported infrequently. Dry throat, sleep apnea syndrome, and exertional dyspnea have been reported rarely.
Ocular side effects including blurred vision (up to 3%) have been reported. Conjunctivitis (including allergic) has been reported frequently. Dry eye, blepharitis, eyelid edema, eye swelling, lenticular opacities, cataract, and hyperemia (including conjunctival) has been reported infrequently.
Musculoskeletal side effects including musculoskeletal stiffness (up to 3%) have been reported. Myalgia and muscle spasms have been reported frequently. Torticollis has been reported rarely.
Dermatologic side effects including rash (up to 3%) have been reported.
Genitourinary side effects including ejaculatory failure (2%) have been reported. Erectile dysfunction has been reported frequently. Testicular pain, amenorrhea, and breast pain have been reported infrequently. Irregular menstruation, gynecomastia, menorrhagia, metrorrhagia, postmenopausal hemorrhage, and prostatitis have been reported rarely.
Psychiatric side effects including restlessness, aggression, and delusion have been reported frequently. Hostility, decreased libido, paranoia, anorgasmia, confusional state, mania, catatonia, mood swings, panic attack, obsessive-compulsive disorder, bulimia nervosa, delirium, polydipsia psychogenic, impulse-control disorder, and major depression have been reported infrequently.
Renal side effects including urinary incontinence have been reported frequently. Dysuria, pollakiuria, enuresis, and nephrolithiasis have been reported infrequently. Urinary retention and acute renal failure have been reported rarely.
Metabolic side effects including dehydration, hypokalemia, and fluid retention have been reported infrequently.
Hematologic side effects including anemia, decreased hemoglobin, increased neutrophil count, decreased hematocrit, and iron deficiency anemia have been reported infrequently. Leukopenia has been reported rarely.
Endocrine side effects including hypothyroidism have been reported infrequently.
Hepatobiliary side effects including cholelithiasis have been reported infrequently.
Other side effects including vertigo and tinnitus have been reported infrequently.