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More frequently reported side effects include: akathisia, blurred vision, constipation, weight gain, and xerostomia. See below for a comprehensive list of adverse effects.For the Consumer
Applies to haloperidol: oral solution, oral tablet
Other dosage forms:
Oral route (Tablet)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol is not approved for the treatment of patients with dementia-related psychosis.
Along with its needed effects, haloperidol 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 haloperidol:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking haloperidol:
Symptoms of overdose
Some side effects of haloperidol 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:
For Healthcare Professionals
Applies to haloperidol: compounding powder, injectable solution, intramuscular solution, oral concentrate, oral tabletGeneral
The most common side effects include extrapyramidal disorder, insomnia, and agitation.Nervous system
Acute dystonia usually occurred early in treatment.
Sedation may occur more frequently in elderly patients.
Akathisia usually occurred within 6 hours of administration and may be indistinguishable from psychotic agitation.
Very common (10% or more): Extrapyramidal disorder (up to 34%), hyperkinesia (up to 13%), headache (up to 12%)
Common (1% to 10%): Tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypertonia, somnolence, masked facies, tremor, dizziness, parkinsonism/parkinsonian effects
Uncommon (0.1% to 1%): Convulsion, akinesia, cogwheel rigidity, sedation, involuntary muscle contractions, gait disturbance, persistent tardive dyskinesia
Rare (0.01% to 0.1%): Motor dysfunction, neuroleptic malignant syndrome, nystagmus
Frequency not reported: Drowsiness, epileptic/grand mal seizure, vertigo, lethargy
Postmarketing reports: OpisthotonosPsychiatric
Very common (10% or more): Insomnia (up to 19%), agitation (up to 15%)
Common (1% to 10%): Depression, psychotic disorder
Uncommon (0.1% to 1%): Confusion, increased/decreased libido, restlessness, hallucinations
Frequency not reported: Apparent exacerbation of psychotic symptoms, anxiety, euphoria, agitation, apprehension, toxic psychosis, catatonic-like behavioral statesGastrointestinal
Common (1% to 10%): Constipation, dry mouth, salivary hypersecretion/hypersalivation, nausea, vomiting
Frequency not reported: Dyspepsia, diarrhea, heartburn, excessive salivationGenitourinary
Common (1% to 10%): Urinary retention, erectile dysfunction, sexual dysfunction
Uncommon (0.1% to 1%): Amenorrhea, dysmenorrhea, galactorrhea, breast discomfort/pain
Rare (0.01% to 0.1%): Menorrhagia, menstrual disorder
Frequency not reported: Priapism, oligomenorrhea, mastalgia, breast engorgement, lactationCardiovascular
Common (1% to 10%): Orthostatic hypotension, hypotension
Uncommon (0.1% to 1%): Tachycardia, edema
Rare (0.01% to 0.1%): QT prolongation (on ECG)
Frequency not reported: Ventricular fibrillation, Torsade de pointes/polymorphous configuration of Torsade de pointes, ventricular tachycardia, extrasystoles, peripheral edema, venous thromboembolism, deep vein thrombosis, unusual bleeding, heat stroke
Postmarketing reports: Ventricular arrhythmia, cardiac arrest, hypertension
QT prolongation, Torsade de pointes, ventricular arrhythmias/fibrillation/tachycardia and cardiac arrest occurred more frequently at high doses and/or in patients at risk for cardiovascular side effects.
Tachycardia and hypotension may occur more frequently in elderly patients. Hypotension occurred as a dose-related event.
Heat stroke included hot, dry skin, the inability to sweat, muscle weakness, and/or confusion.Metabolic
Hyperammonemia occurred in a pediatric patient with citrullinemia (inherited disorder of ammonia excretion).
Common (1% to 10%): Weight increased/decreased
Frequency not reported: Hypoglycemia, hyperglycemia, loss of appetite, anorexia, hyponatremia
Postmarketing reports: HyperammonemiaOcular
Common (1% to 10%): Oculogyric crisis, visual disturbance
Uncommon (0.1% to 1%): Blurred vision
Frequency not reported: Cataracts, retinopathyDermatologic
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Photosensitivity reaction, urticaria, pruritus, hyperhidrosis
Frequency not reported: Exfoliative dermatitis, leukocytoclastic vasculitis, Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, maculopapular/acneiform skin reactions, alopeciaMusculoskeletal
Common (1% to 10%): Muscle rigidity
Uncommon (0.1% to 1%): Torticollis, muscle spasms, musculoskeletal stiffness
Rare (0.01% to 0.1%): Trismus, muscle twitching
Postmarketing reports: RhabdomyolysisOther
Common (1% to 10%): Hyperthermia
Uncommon (0.1% to 1%): Unusual tiredness/weakness
Frequency not reported: Neonatal drug withdrawal syndrome, sudden/unexpected death, face edema, hypothermiaHepatic
Common (1% to 10%): Abnormal liver function test
Uncommon (0.1% to 1%): Hepatitis, jaundice
Frequency not reported: Acute hepatic failure, cholestasis, impaired liver functionLocal
Common (1% to 10%): Injection site reaction
Frequency not reported: Injection site abscesses, localized erythema/swelling/tender lumpsRespiratory
Uncommon (0.1% to 1%): Dyspnea
Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Laryngeal edema, laryngospasm, pulmonary embolism, increased respiratory rate/depth, sore throat, bronchopneumonia/lethal bronchopneumoniaHematologic
Agranulocytosis included sore throat/fever and unusual bleeding/bruising, and typically occurred with concurrent use of other drugs.
Leukopenia and leukocytosis were usually mild and transient.
Uncommon (0.1% to 1%): Leukopenia
Frequency not reported: Agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, unusual bruising, decreased red blood cell counts, anemia, lymphocytosis, monocytosis, lymphomonocytosisHypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactionEndocrine
Inappropriate antidiuretic hormone secretion occurred with hyponatremia
Rare (0.01% to 0.1%): Hyperprolactinemia
Frequency not reported: Inappropriate antidiuretic hormone secretion, gynecomastia
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October 19, 2020
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