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

Stem definition	Drug id	CAS RN
	4496	74050-97-8

Description:

Molecule	Description
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

Molecule

Description

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:

Date	Agency	Company	Orphan
Jan. 14, 1986	FDA	JANSSEN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	7.95	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	INVERSE AGONIST	Ki	9.34	CHEMBL	CHEMBL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	8.46	CHEMBL
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN		Ki	8.24	CHEMBL
D(1A) dopamine receptor	GPCR		DRD1_PIG		Ki	6.85	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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