Fanapt Titration Pack Side Effects

Please note - some side effects for Fanapt Titration Pack may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral kit; oral tablet

Nervous system

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

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

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

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

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

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

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

Dermatologic side effects including rash (up to 3%) have been reported.

Genitourinary

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

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

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

Metabolic side effects including dehydration, hypokalemia, and fluid retention have been reported infrequently.

Hematologic

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

Endocrine side effects including hypothyroidism have been reported infrequently.

Hepatic

Hepatobiliary side effects including cholelithiasis have been reported infrequently.

Other

Other side effects including vertigo and tinnitus have been reported infrequently.

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