haloperidol decanoate 🐶 Veterinary Use | 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 207.38 34.03 50 1232 11720 50592122
Weight increased 128.01 34.03 73 1209 201818 50402024
Cervix neoplasm 72.82 34.03 11 1271 203 50603639
Neuroleptic malignant syndrome 61.42 34.03 19 1263 11111 50592731
Central obesity 55.64 34.03 11 1271 1011 50602831
Intentional self-injury 34.32 34.03 15 1267 23097 50580745

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 290.45 32.53 84 2647 10747 29561049
Weight increased 134.47 32.53 85 2646 76582 29495214
Neuroleptic malignant syndrome 131.09 32.53 51 2680 16097 29555699
Akathisia 94.87 32.53 32 2699 6710 29565086
Peptostreptococcus infection 54.53 32.53 8 2723 27 29571769
Blood pressure measurement 54.37 32.53 10 2721 164 29571632
Incorrect route of product administration 44.06 32.53 21 2710 10780 29561016
Tardive dyskinesia 43.98 32.53 17 2714 5241 29566555
Parkinsonism 41.91 32.53 18 2713 7260 29564536
Antipsychotic drug level below therapeutic 38.45 32.53 12 2719 1962 29569834
Weight bearing difficulty 38.33 32.53 10 2721 861 29570935
Muscle rigidity 37.48 32.53 18 2713 9393 29562403
Suicide attempt 36.44 32.53 28 2703 34082 29537714
Delusion 34.48 32.53 18 2713 11198 29560598

FDA Adverse Event Reporting System (Geriatric)

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 482.09 28.09 127 3427 19425 64475753
Weight increased 243.85 28.09 149 3405 213199 64281979
Neuroleptic malignant syndrome 138.56 28.09 52 3502 24944 64470234
Akathisia 82.61 28.09 29 3525 11481 64483697
Cervix neoplasm 65.56 28.09 11 3543 179 64494999
Muscle rigidity 54.22 28.09 24 3530 17449 64477729
Peptostreptococcus infection 52.67 28.09 8 3546 66 64495112
Blood pressure measurement 51.31 28.09 10 3544 386 64494792
Tardive dyskinesia 50.45 28.09 19 3535 9159 64486019
Intentional self-injury 45.39 28.09 25 3529 29019 64466159
Central obesity 43.23 28.09 11 3543 1444 64493734
Catatonia 42.70 28.09 16 3538 7604 64487574
Parkinsonism 42.21 28.09 19 3535 14354 64480824
Delusion 38.12 28.09 19 3535 17995 64477183
Incorrect route of product administration 36.25 28.09 20 3534 23278 64471900
Hallucination, auditory 36.24 28.09 18 3536 16921 64478257
Injection site erosion 34.78 28.09 6 3548 116 64495062
Pancreatitis necrotising 34.60 28.09 11 3543 3206 64491972
Dystonia 34.41 28.09 18 3536 18847 64476331
Weight bearing difficulty 32.23 28.09 10 3544 2693 64492485
Treatment noncompliance 31.48 28.09 23 3531 43459 64451719
Suicide attempt 31.10 28.09 28 3526 70979 64424199
Hypertonia 30.84 28.09 12 3542 6313 64488865
Psychotic disorder 28.97 28.09 20 3534 34558 64460620

FDA Adverse Event Reporting System (Pediatric)

None

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
MeSH PA D018726 Anti-Dyskinesia Agents
MeSH PA D000932 Antiemetics
MeSH PA D015259 Dopamine Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
CHEBI has role CHEBI:48279 serotonin antagonists
CHEBI has role CHEBI:48561 dopaminergic antagonists
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:65190 typical antipsychotic drugs
CHEBI has role CHEBI:66956 antidyskinetic agent
FDA EPC N0000180182 Typical Antipsychotic

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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(3) dopamine receptor GPCR Ki 8.46 CHEMBL
D(4) dopamine receptor GPCR Ki 8.24 CHEMBL
D(1A) dopamine receptor GPCR Ki 6.85 CHEMBL

External reference:

IDSource
D01898 KEGG_DRUG
4018124 VUID
N0000179148 NUI
4018123 VANDF
4018124 VANDF
CHEBI:31664 CHEBI
CHEBI:5613 CHEBI
CHEMBL1200986 ChEMBL_ID
C033563 MESH_SUPPLEMENTAL_RECORD_UI
AC20PJ4101 UNII
52919 PUBCHEM_CID
3559 PUBCHEM_CID
DB00502 DRUGBANK_ID
26420 RXNORM
11634 MMSL
3626 MMSL
4816 MMSL
4817 MMSL
583 MMSL
d00027 MMSL
001518 NDDF
001519 NDDF
10756001 SNOMEDCT_US
386837002 SNOMEDCT_US
412196004 SNOMEDCT_US
C0062103 UMLSCUI
C0018546 UMLSCUI
918 INN_ID
D006220 MESH_DESCRIPTOR_UI

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 0703-7121 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 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 63323-471 INJECTION 100 mg INTRAMUSCULAR ANDA 22 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 63323-471 INJECTION 100 mg INTRAMUSCULAR ANDA 22 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
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-382 INJECTION 50 mg INTRAMUSCULAR ANDA 17 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-383 INJECTION 100 mg INTRAMUSCULAR ANDA 17 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 70069-384 INJECTION 100 mg INTRAMUSCULAR ANDA 17 sections
haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 70518-1281 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 21 sections