pharmacopeia
GET
/api/v1/drug/haloperidol

Boxed warning

WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).

2D structure
4-[4-(4-chlorophenyl)-4-hydroxypiperidin-1-yl]-1-(4-fluorophenyl)butan-1-one
SMILES C1CN(CCC1(C2=CC=C(C=C2)Cl)O)CCCC(=O)C3=CC=C(C=C3)F
InChIKey LNEPOXFFQSENCJ-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Dopamine Antagonists.

Dopamine

Indications

Sourced from openFDA
  • Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults.

Contraindications

Sourced from openFDA
  • Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.contraindicated

Dosage & administration

Sourced from openFDA

There is considerable variation from patient to patient in the amount of medication required for treatment. As with all antipsychotic drugs, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Children, debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels, as recommended below. Clinical experience suggests the following recommendations: Oral Administration Initial Dosage Range Adults Moderate Symptomatology - 0.5 mg to 2 mg b.i.d. or t.i.d. Severe Symptomatology - 3 mg to 5 mg b.i.d. or t.i.d. To achieve prompt control, higher doses may be required in some cases. Geriatric or Debilitated Patients - 0.5 mg to 2 mg b.i.d. or t.i.d. Chronic or Resistant Patients - 3 mg to 5 mg b.i.d. or t.i.d. Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response.

Warnings & precautions

Sourced from openFDA

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING). Cardiovascular Effects Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Higher than recommended doses of any formulation of haloperidol appear to be associated with a higher risk of QT-prolongation and Torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Adverse reactions

Sourced from openFDA

Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of Torsades de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS). Cases of sudden and unexpected death have been reported in association with the administration of haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, haloperidol played in the outcome of the reported cases. The possibility that haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs. CNS Effects Extrapyramidal Symptoms (EPS) EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate, USP or trihexyphenidyl hydrochloride, USP. It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases.

Overdosage

Sourced from openFDA

Manifestations In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reaction would be manifest by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively. With accidental overdosage, hypertension rather than hypotension occurred in a 2 year old child. The risk of ECG changes associated with Torsades de pointes should be considered. (For further information regarding Torsades de pointes, please refer to ADVERSE REACTIONS.) Treatment Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal. Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy.

Approval history

Sourced from openFDA
  • Jan 14, 1986NDANDA018701Janssen Pharms
  • Jun 10, 1986ANDAANDA070278Mylan
  • Feb 17, 1987ANDAANDA071130Aiping Pharm Inc
  • Jan 7, 1988ANDAANDA071173Innogenix
  • Feb 26, 1993ANDAANDA073037Pharm Assoc
  • Sep 28, 1993ANDAANDA073364Lannett Co Inc
  • Dec 19, 1997ANDAANDA074893Fresenius Kabi Usa
  • Sep 28, 1998ANDAANDA075305Hikma

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
26,657 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective2,2998.6%
  2. 2Drug Interaction1,8236.8%
  3. 3Neuroleptic Malignant Syndrome1,7466.5%
  4. 4Off Label Use1,5445.8%
  5. 5Weight Increased1,4425.4%
  6. 6Extrapyramidal Disorder1,3965.2%
  7. 7Toxicity To Various Agents1,1554.3%
  8. 8Agitation9393.5%
  9. 9Somnolence9073.4%
  10. 10Pyrexia8713.3%
  11. 11Condition Aggravated8523.2%
  12. 12Delirium8013.0%
  13. 13Confusional State7993.0%
  14. 14Tremor7903.0%
  15. 15Vomiting7752.9%

Literature

View JSON

Recent PubMed references pinned to Haloperidol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 196 ClinicalTrials.gov registrations naming Haloperidol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Haloperidol. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC B/C (provisional)ClinPGx 1A
  • MC4RCPIC C (provisional)ClinPGx 3

Frequently asked questions

How does Haloperidol work?
Mechanism-of-action class: Dopamine Antagonists.
What is Haloperidol used for?
According to FDA labeling, Haloperidol carries indications including: Haloperidol tablets are indicated for use in the management of manifestations of psychotic disorders. Haloperidol tablets are indicated for the control of tics and vocal utterances of Tourette's Disorder in children and adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Haloperidol?
Haloperidol is classified as Butyrophenone derivatives, Typical Antipsychotic, Dopamine Antagonists, Decreased Brain Stem Organized Electrical Activity, Decreased Central Nervous System Organized Electrical Activity, Decreased Dopamine Activity, Hypothalamic Endocrine Activity Alteration.
What are the brand names for Haloperidol?
Haloperidol is marketed under brand names including Haldol.
What are the contraindications for Haloperidol?
Haloperidol labeling lists contraindications including: Haloperidol tablets are contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.. Always consult the full prescribing information and a clinician.
Note. Data for haloperidol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients