haloperidol decanoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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:

PropertyValueReference
BA (Bioavailability) 65 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK1,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK 53
kinase-selectivity-class AKT2,AKT3,AXL,EIF2AK3,EPHB4,GRK2,PDK4,PRKCD,SIK2,STK33,TEK 11
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 252.10 35.71 61 1982 16242 90610162
Weight increased 112.82 35.71 85 1958 417842 90208562
Neuroleptic malignant syndrome 109.44 35.71 31 2012 15065 90611339
Treatment noncompliance 92.40 35.71 37 2006 51690 90574714
Catatonia 90.07 35.71 22 2021 6034 90620370
Cervix neoplasm 73.98 35.71 11 2032 205 90626199
Central obesity 53.53 35.71 11 2032 1379 90625025
Salivary hypersecretion 49.65 35.71 15 2028 9077 90617327
Hallucination, auditory 48.96 35.71 17 2026 15958 90610446
Muscle rigidity 42.97 35.71 15 2028 14294 90612110
Akathisia 38.58 35.71 13 2030 11146 90615258
Tremor 38.49 35.71 30 2013 153143 90473261
Withdrawal catatonia 37.45 35.71 6 2037 185 90626219
Electrocardiogram QT prolonged 36.94 35.71 22 2021 72434 90553970

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 331.10 33.18 106 4476 16306 42600447
Akathisia 267.34 33.18 81 4501 10370 42606383
Antipsychotic drug level below therapeutic 204.51 33.18 51 4531 3153 42613600
Weight increased 197.21 33.18 130 4452 107853 42508900
Therapeutic product effect variable 195.99 33.18 49 4533 3060 42613693
Disinhibition 189.82 33.18 50 4532 3845 42612908
Neuroleptic malignant syndrome 175.08 33.18 71 4511 21401 42595352
Euphoric mood 169.14 33.18 51 4531 6402 42610351
Obsessive-compulsive disorder 162.68 33.18 50 4532 6693 42610060
Increased appetite 152.97 33.18 51 4531 8855 42607898
Suicide attempt 148.09 33.18 80 4502 46020 42570733
Obesity 99.36 33.18 44 4538 16415 42600338
Dyslipidaemia 93.71 33.18 36 4546 9382 42607371
Prescribed overdose 92.59 33.18 39 4543 12888 42603865
Schizoaffective disorder 89.80 33.18 24 4558 1946 42614807
Emotional poverty 85.89 33.18 19 4563 693 42616060
Parkinsonism 79.26 33.18 33 4549 10590 42606163
Irritability 74.35 33.18 43 4539 28085 42588668
Dystonia 70.19 33.18 32 4550 12758 42603995
Leukaemia 68.09 33.18 25 4557 5747 42611006
Treatment noncompliance 67.59 33.18 45 4537 37627 42579126
Tardive dyskinesia 67.20 33.18 26 4556 6898 42609855
Leukopenia 64.95 33.18 58 4524 74688 42542065
Therapeutic product effect incomplete 61.54 33.18 55 4527 70884 42545869
Sedation 61.01 33.18 39 4543 30436 42586317
Catatonia 55.51 33.18 22 4560 6217 42610536
Peptostreptococcus infection 47.77 33.18 8 4574 62 42616691
Delusion 45.62 33.18 25 4557 14709 42602044
Muscle rigidity 36.06 33.18 20 4562 12039 42604714
Jaw clicking 34.19 33.18 6 4576 63 42616690
Blood pressure measurement 33.53 33.18 7 4575 193 42616560
Product use in unapproved indication 33.43 33.18 66 4516 184390 42432363

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 586.46 29.51 159 5577 28708 110554855
Weight increased 252.55 29.51 193 5543 419451 110164112
Akathisia 250.25 29.51 73 5663 17040 110566523
Neuroleptic malignant syndrome 231.18 29.51 81 5655 33978 110549585
Antipsychotic drug level below therapeutic 173.92 29.51 35 5701 1700 110581863
Disinhibition 153.29 29.51 35 5701 3099 110580464
Therapeutic product effect variable 152.75 29.51 34 5702 2684 110580879
Catatonia 129.65 29.51 40 5696 11260 110572303
Obsessive-compulsive disorder 124.19 29.51 35 5701 7206 110576357
Suicide attempt 123.37 29.51 73 5663 103321 110480242
Euphoric mood 121.70 29.51 36 5700 8791 110574772
Treatment noncompliance 109.85 29.51 60 5676 72930 110510633
Increased appetite 99.16 29.51 35 5701 14942 110568621
Parkinsonism 96.16 29.51 38 5698 22149 110561414
Dyslipidaemia 93.24 29.51 34 5702 15931 110567632
Schizoaffective disorder 91.10 29.51 23 5713 3113 110580450
Emotional poverty 86.67 29.51 18 5718 1022 110582541
Leukopenia 79.38 29.51 64 5672 148727 110434836
Irritability 76.63 29.51 41 5695 47768 110535795
Muscle rigidity 73.18 29.51 32 5704 23999 110559564
Sedation 69.73 29.51 44 5692 69639 110513924
Dystonia 67.83 29.51 31 5705 25774 110557789
Hallucination, auditory 67.16 29.51 31 5705 26366 110557197
Cervix neoplasm 66.04 29.51 11 5725 182 110583381
Salivary hypersecretion 65.69 29.51 27 5709 17394 110566169
Tardive dyskinesia 64.99 29.51 25 5711 13554 110570009
Leukaemia 63.14 29.51 21 5715 7497 110576066
Delusion 51.54 29.51 25 5711 23730 110559833
Peptostreptococcus infection 45.87 29.51 8 5728 176 110583387
Prescribed overdose 45.24 29.51 37 5699 87544 110496019
Obesity 44.62 29.51 41 5695 113310 110470253
Tremor 41.89 29.51 52 5684 202180 110381383
Central obesity 40.22 29.51 11 5725 2025 110581538
Hyperthermia 39.08 29.51 20 5716 21252 110562311
Persecutory delusion 38.97 29.51 14 5722 6277 110577286
Intentional self-injury 35.84 29.51 23 5713 37406 110546157
Hyperprolactinaemia 34.69 29.51 13 5723 6562 110577001
Coma 34.02 29.51 36 5700 117833 110465730
Dyskinesia 33.65 29.51 25 5711 51421 110532142
Drooling 33.64 29.51 13 5723 7126 110576437
Pancreatitis necrotising 33.17 29.51 12 5724 5489 110578074
Injection site erosion 32.58 29.51 6 5730 181 110583382
Blood pressure measurement 31.81 29.51 7 5729 523 110583040
Agitation 31.69 29.51 34 5702 113017 110470546
Electrocardiogram QT prolonged 30.95 29.51 33 5703 108927 110474636
Schizophrenia 30.21 29.51 17 5719 21809 110561754

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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 D014150 Antipsychotic Agents
MeSH PA D000932 Antiemetics
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D018726 Anti-Dyskinesia Agents
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:65190 first generation antipsychotic
CHEBI has role CHEBI:66956 antidyskinesia agent
FDA EPC N0000180182 Typical Antipsychotic
CHEBI has role CHEBI:35476 antipsychotic agent

Drug Use | Suggest Off label Use Form| |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
CHEMBL1200986 ChEMBL_ID
C033563 MESH_SUPPLEMENTAL_RECORD_UI
AC20PJ4101 UNII
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
DB00502 DRUGBANK_ID
52919 PUBCHEM_CID
3559 PUBCHEM_CID
918 INN_ID
D006220 MESH_DESCRIPTOR_UI
CHEBI:5613 CHEBI
AC20PJ4101 INXIGHT DRUGS

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 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 34 sections
Haldol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 50458-253 INJECTION 50 mg INTRAMUSCULAR NDA 34 sections
Haldol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 50458-254 INJECTION 100 mg INTRAMUSCULAR NDA 34 sections
Haldol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 50458-254 INJECTION 100 mg INTRAMUSCULAR NDA 34 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 65145-167 INJECTION 100 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate Human Prescription Drug Label 1 65145-168 INJECTION 50 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate Human Prescription Drug Label 1 65145-169 INJECTION 100 mg INTRAMUSCULAR ANDA 20 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-409 INJECTION 100 mg INTRAMUSCULAR ANDA 27 sections
Haloperidol Decanoate HUMAN PRESCRIPTION DRUG LABEL 1 67457-410 INJECTION 50 mg INTRAMUSCULAR ANDA 27 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 68001-578 INJECTION 50 mg INTRAMUSCULAR ANDA 18 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 68001-579 INJECTION 100 mg INTRAMUSCULAR ANDA 18 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 68001-580 INJECTION 50 mg INTRAMUSCULAR ANDA 18 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 68001-581 INJECTION 100 mg INTRAMUSCULAR ANDA 18 sections
HALOPERIDOL DECANOATE HUMAN PRESCRIPTION DRUG LABEL 1 68001-582 INJECTION 500 mg INTRAMUSCULAR ANDA 18 sections
Haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 68001-657 INJECTION 50 mg INTRAMUSCULAR ANDA 28 sections
Haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 68001-657 INJECTION 50 mg INTRAMUSCULAR ANDA 28 sections
Haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 68001-658 INJECTION 100 mg INTRAMUSCULAR ANDA 28 sections
Haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 68001-658 INJECTION 100 mg INTRAMUSCULAR ANDA 28 sections
Haloperidol decanoate HUMAN PRESCRIPTION DRUG LABEL 1 68001-659 INJECTION 500 mg INTRAMUSCULAR ANDA 28 sections