haloperidol decanoate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4496 74050-97-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • haloperidol decanoate
  • haldol decanoate
  • Molecular weight: 530.12
  • Formula: C31H41ClFNO3
  • CLOGP: 8.94
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 0
  • TPSA: 46.61
  • ALOGS: -6.97
  • ROTB: 16

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 14, 1986 FDA JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Extrapyramidal disorder 208.56 37.97 50 1158 11218 46673636
Weight increased 140.74 37.97 73 1135 164400 46520454
Cervix neoplasm 64.99 37.97 10 1198 205 46684649
Neuroleptic malignant syndrome 61.04 37.97 19 1189 11103 46673751
Central obesity 51.41 37.97 10 1198 827 46684027
Schizophrenia 40.22 37.97 13 1195 8555 46676299

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Extrapyramidal disorder 267.15 33.11 76 2317 10617 29939468
Weight increased 142.50 33.11 83 2310 74830 29875255
Neuroleptic malignant syndrome 119.71 33.11 46 2347 16249 29933836
Akathisia 78.86 33.11 26 2367 5878 29944207
Blood pressure measurement 50.16 33.11 9 2384 149 29949936
Parkinsonism 44.45 33.11 18 2375 7251 29942834
Tardive dyskinesia 43.32 33.11 16 2377 5041 29945044
Psychotic disorder 41.10 33.11 24 2369 21491 29928594
Incorrect route of product administration 39.84 33.11 19 2374 11296 29938789
Muscle rigidity 38.49 33.11 18 2375 10243 29939842
Antipsychotic drug level below therapeutic 35.26 33.11 10 2383 1362 29948723
Weight bearing difficulty 34.81 33.11 9 2384 866 29949219

Pharmacologic Action:

SourceCodeDescription
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Chronic schizophrenia indication 83746006
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Thyrotoxic crisis contraindication 29028009 DOID:12837
Torsades de pointes contraindication 31722008
Parkinsonism contraindication 32798002
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Low blood pressure contraindication 45007003
Extrapyramidal disease contraindication 76349003
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Disease of liver contraindication 235856003 DOID:409
Retention of urine contraindication 267064002
Neutropenic disorder contraindication 303011007 DOID:1227
Coma contraindication 371632003
Breastfeeding (mother) contraindication 413712001
Central nervous system depression contraindication 418072004
Acquired torsion dystonia contraindication 433493000
Congenital long QT syndrome contraindication 442917000
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Drug Induced CNS Depression contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.95 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR INVERSE AGONIST Ki 9.34 CHEMBL CHEMBL
D(4) dopamine receptor GPCR Ki 8.24 CHEMBL
D(3) dopamine receptor GPCR Ki 8.46 CHEMBL
D(1A) dopamine receptor GPCR Ki 6.85 CHEMBL

External reference:

IDSource
D01898 KEGG_DRUG
4018124 VUID
N0000179148 NUI
4018124 VANDF
C0591586 UMLSCUI
CHEBI:31664 CHEBI
CHEMBL1200986 ChEMBL_ID
C033563 MESH_SUPPLEMENTAL_RECORD_UI
AC20PJ4101 UNII
52919 PUBCHEM_CID
DB00502 DRUGBANK_ID
26420 RXNORM
11634 MMSL
3626 MMSL
4817 MMSL
001519 NDDF
412196004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9295 INJECTION 100 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9296 INJECTION 100 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7011 INJECTION 50 mg INTRAMUSCULAR ANDA 23 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7013 INJECTION 50 mg INTRAMUSCULAR ANDA 23 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7021 INJECTION 100 mg INTRAMUSCULAR ANDA 23 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7023 INJECTION 100 mg INTRAMUSCULAR ANDA 23 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7121 INJECTION 50 mg INTRAMUSCULAR ANDA 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7123 INJECTION 50 mg INTRAMUSCULAR ANDA 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7131 INJECTION 100 mg INTRAMUSCULAR ANDA 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 0703-7133 INJECTION 100 mg INTRAMUSCULAR ANDA 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 10147-0921 INJECTION 50 mg INTRAMUSCULAR NDA AUTHORIZED GENERIC 25 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 10147-0922 INJECTION 100 mg INTRAMUSCULAR NDA AUTHORIZED GENERIC 25 sections
haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 25021-831 INJECTION, SOLUTION 50 mg INTRAMUSCULAR ANDA 23 sections
haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 25021-833 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 23 sections
haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 25021-834 INJECTION, SOLUTION 500 mg INTRAMUSCULAR ANDA 23 sections
Haldol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 50458-253 INJECTION 50 mg INTRAMUSCULAR NDA 23 sections
Haldol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 50458-254 INJECTION 100 mg INTRAMUSCULAR NDA 23 sections
Haloperidol Decanoate Human Prescription Drug Label 1 63323-469 INJECTION 50 mg INTRAMUSCULAR ANDA 13 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 63323-471 INJECTION 100 mg INTRAMUSCULAR ANDA 13 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 63323-471 INJECTION 100 mg INTRAMUSCULAR ANDA 13 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 64725-0471 INJECTION 100 mg INTRAMUSCULAR ANDA 13 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-381 INJECTION 100 mg INTRAMUSCULAR ANDA 14 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-382 INJECTION 50 mg INTRAMUSCULAR ANDA 14 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-409 INJECTION 100 mg INTRAMUSCULAR ANDA 14 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-410 INJECTION 50 mg INTRAMUSCULAR ANDA 14 sections
Haloperidol Decanoate Human Prescription Drug Label 1 68083-137 INJECTION 50 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate Human Prescription Drug Label 1 68083-138 INJECTION 100 mg INTRAMUSCULAR ANDA 20 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-030 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-031 INJECTION 100 mg INTRAMUSCULAR ANDA 17 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-381 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections