drug
as of 2026-07-01Haloperidol
haloperidolHaloperidol 10mgIntramuscular HaloperidolHaloperidol Decanoatehaloperidol decanoateHaloperidol-HaloperidolHaloperidol and RamelteonHaloperidol 10 mg Tablets (Cord Laboratories)
MeSH D006220UNII AC20PJ4101RxCUI 1719803, 1719862, 1719847, 1720026FDA_ApplNo NDA018701SPL_set_id af0159a8-dff5-449a-aa2b-a0c430081e21FDA_sponsor JANSSEN PHARMSOrangeBook_Appl A070278, A070318, A070710, A070713, A070714, A070720, A070721, A070722
at a glance
small molecule
US-approved (1986) as Haldol Decanoate
42 trials in the graph
Synthesized from structured facts only — each point cited above.
Mechanism & identity
Modality
small molecule
Mechanism of action
12.1 Mechanism of Action The mechanism of action of HALDOL DECANOATE for the treatment of schizophrenia in adults is unclear. However, its effect in schizophrenia could be mediated through its activity as an antagonist at central dopamine type 2 receptors. Haloperidol also binds to alpha-1 adrenergic receptors, but with lower affinity, and displays minimal binding to muscarinic cholinergic and histaminergic (H 1 ) receptors.
Indications
Labeled
Schizophrenia
Investigational (via trials)
Adverse-event signal
FAERS spontaneous · within-drug share
Eps Akathisia10.4%
top term: EXTRAPYRAMIDAL DISORDER
Sedation5.2%
top term: SOMNOLENCE
Qt Cardiac4.4%
top term: TACHYCARDIA
Gi3.8%
top term: VOMITING
Hematologic3.5%
top term: NEUTROPENIA
Mortality3.4%
top term: DEATH
Nms3.2%
top term: NEUROLEPTIC MALIGNANT SYNDROME
Weight Metabolic3.1%
top term: WEIGHT INCREASED
Orthostatic1.1%
top term: HYPOTENSION
Anticholinergic0.8%
top term: CONSTIPATION
Prolactin0.5%
top term: HYPERPROLACTINAEMIA
Spontaneous reports — a signal of reporting share, not incidence.
Trials
42
The IM-ZBULLE Study : " Z-track " and " Airlock " Techniques During Intramuscular Injection of Haloperidol Decanoate
NCT05995457—Unknown
A Study of Olanzapine in Patients With Acute Agitation
NCT05803642Phase 3Unknown
Reducing the Burden of Chronic Psychotic Disorders in Tanzania (CAPACITY)
NCT04327843Phase 3Completed
A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform
NCT02431702Phase 3Completed
Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)
NCT02600741—Completed
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
NCT03075657Phase 4Completed
Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia
NCT02240173Phase 1, Phase 2Unknown
Pharmacovigilance in Gerontopsychiatric Patients
NCT02374567Phase 3Terminated
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients
NCT02307396Phase 4Completed
Lurasidone Effects on Tissue Glutamate in Schizophrenia
NCT02199743Phase 4Completed
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
NCT01157351Phase 4Completed
Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia
NCT01164059Phase 4Completed
A Comparison of Long-acting Injectable Medications for Schizophrenia
NCT01136772Phase 4Completed
Twelve Month Study Comparing Paliperidone Palmitate and Select Oral Antipsychotics in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric Hospital
NCT01193166Phase 4Withdrawn
Customized Adherence Enhancement Plus Long-acting Injectable Antipsychotic
NCT01152697—Completed
Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia
NCT01052389Phase 4Completed
Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning
NCT01161277Phase 4Completed
A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia
NCT00866645Phase 2, Phase 3Completed
Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia
NCT00838032Phase 4Unknown
A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
NCT00642369—Completed
A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation
NCT00723606Phase 3Completed
Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia
NCT00797277Phase 3Completed
KOLs & investigators
12
Stefan Leucht, ProfessorKOL score 87
Martha Sajatovic, MDKOL score 7
Scott Stroup, MD, MPHKOL score 5
Tianmei Si, MDKOL score 5
Helge Frieling, Prof., MDKOL score 5
Carol A. Tamminga, M.D.KOL score 5
Alan I. Green, MDKOL score 5
Joseph P. McEvoy, MDKOL score 4
Huafang Li, MD, PhDKOL score 3
Debasish Hota, MD, DMKOL score 2
Barbara D'Avanzo, Phil.D.KOL score 0
Facts & assertions
25 sourced
Anda Generic Count
182
Boxed Warning
present
Dosing Frequency
see label
Faers Share Anticholinergic
0.008
Faers Share Eps Akathisia
0.104
Faers Share Gi
0.038
Faers Share Hematologic
0.035
Faers Share Mortality
0.034
Faers Share Nms
0.032
Faers Share Orthostatic
0.011
Faers Share Prolactin
0.005
Faers Share Qt Cardiac
0.044
Faers Share Sedation
0.052
Faers Share Weight Metabolic
0.031
Has Generic Competition
yes
Mechanism Of Action
12.1 Mechanism of Action The mechanism of action of HALDOL DECANOATE for the treatment of schizophrenia in adults is unclear. However, its effect in schizophrenia could be mediated through its activity as an antagonist at central dopamine type 2 receptors. Haloperidol also binds to alpha-1 adrenergi
Originator Company
Janssen Pharms
Safety Eps Akathisia
present in label
Safety Nms
present in label
Safety Orthostatic
present in label
Safety Prolactin
present in label
Safety Qt Prolongation
present in label
Safety Sedation Somnolence
present in label
Us Approved
yes
Us Original Approval Date
1986-01-14
relationships
The graph out of here
developer
trial
indication
indication
indication
indication
indication
KOL
Stefan Leucht, Professor
personKOL score 87
Martha Sajatovic, MD
personKOL score 7
Scott Stroup, MD, MPH
personKOL score 5
Tianmei Si, MD
personKOL score 5