Haldol Side Effects
Generic name: haloperidol
Medically reviewed by Drugs.com. Last updated on Oct 4, 2023.
Note: This document contains side effect information about haloperidol. Some dosage forms listed on this page may not apply to the brand name Haldol.
For healthcare professionals
Applies to haloperidol: compounding powder, injectable solution, intramuscular solution, oral concentrate, oral tablet.
General adverse events
The most common side effects include extrapyramidal disorder, insomnia, and agitation.[Ref]
Nervous system
- 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: Opisthotonos[Ref]
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.[Ref]
Psychiatric
- 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 states[Ref]
Gastrointestinal
- Common (1% to 10%): Constipation, dry mouth, salivary hypersecretion/hypersalivation, nausea, vomiting
- Frequency not reported: Dyspepsia, diarrhea, heartburn, excessive salivation[Ref]
Genitourinary
- 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, lactation[Ref]
Cardiovascular
- 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[Ref]
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.[Ref]
Metabolic
- Common (1% to 10%): Weight increased/decreased
- Frequency not reported: Hypoglycemia, hyperglycemia, loss of appetite, anorexia, hyponatremia
- Postmarketing reports: Hyperammonemia[Ref]
Hyperammonemia occurred in a pediatric patient with citrullinemia (inherited disorder of ammonia excretion).[Ref]
Ocular
- Common (1% to 10%): Oculogyric crisis, visual disturbance
- Uncommon (0.1% to 1%): Blurred vision
- Frequency not reported: Cataracts, retinopathy[Ref]
Dermatologic
- 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, alopecia[Ref]
Musculoskeletal
- 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: Rhabdomyolysis[Ref]
Other
- 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, hypothermia[Ref]
Hepatic
- Common (1% to 10%): Abnormal liver function test
- Uncommon (0.1% to 1%): Hepatitis, jaundice
- Frequency not reported: Acute hepatic failure, cholestasis, impaired liver function[Ref]
Local
- Common (1% to 10%): Injection site reaction
- Frequency not reported: Injection site abscesses, localized erythema/swelling/tender lumps[Ref]
Respiratory
- 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 bronchopneumonia[Ref]
Hematologic
- Uncommon (0.1% to 1%): Leukopenia
- Frequency not reported: Agranulocytosis, neutropenia, pancytopenia, thrombocytopenia, unusual bruising, decreased red blood cell counts, anemia, lymphocytosis, monocytosis, lymphomonocytosis[Ref]
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.[Ref]
Hypersensitivity
- Uncommon (0.1% to 1%): Hypersensitivity reactions
- Frequency not reported: Anaphylactic reaction[Ref]
Endocrine
- Rare (0.01% to 0.1%): Hyperprolactinemia
- Frequency not reported: Inappropriate antidiuretic hormone secretion, gynecomastia[Ref]
Inappropriate antidiuretic hormone secretion occurred with hyponatremia[Ref]
See also:
References
1. (2002) "Product Information. Haldol (haloperidol)." McNeil Pharmaceutical
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
Frequently asked questions
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Further information
Haldol side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.