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	249.93	37.19	59	1479	13225	63474259
Weight increased	118.44	37.19	75	1463	260717	63226767
Cervix neoplasm	73.15	37.19	11	1527	206	63487278
Neuroleptic malignant syndrome	64.95	37.19	20	1518	12036	63475448
Central obesity	54.17	37.19	11	1527	1210	63486274
Hallucination, auditory	43.54	37.19	15	1523	12809	63474675
Treatment noncompliance	42.95	37.19	20	1518	37305	63450179
Muscle rigidity	37.29	37.19	13	1525	11487	63475997

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	287.08	33.60	87	3205	12793	34940846
Weight increased	155.99	33.60	101	3191	92932	34860707
Akathisia	151.87	33.60	48	3244	8061	34945578
Neuroleptic malignant syndrome	138.70	33.60	55	3237	17879	34935760
Antipsychotic drug level below therapeutic	91.50	33.60	25	3267	2522	34951117
Therapeutic product effect variable	83.10	33.60	23	3269	2433	34951206
Suicide attempt	81.81	33.60	49	3243	39067	34914572
Disinhibition	81.26	33.60	24	3268	3202	34950437
Euphoric mood	71.91	33.60	25	3267	5616	34948023
Obsessive-compulsive disorder	68.39	33.60	24	3268	5540	34948099
Emotional poverty	63.31	33.60	14	3278	584	34953055
Increased appetite	61.63	33.60	24	3268	7405	34946234
Peptostreptococcus infection	54.37	33.60	8	3284	27	34953612
Blood pressure measurement	53.83	33.60	10	3282	170	34953469
Obesity	48.94	33.60	24	3268	12854	34940785
Tardive dyskinesia	45.54	33.60	18	3274	5772	34947867
Parkinsonism	42.82	33.60	19	3273	8119	34945520
Incorrect route of product administration	40.10	33.60	22	3270	14823	34938816
Muscle rigidity	38.17	33.60	19	3273	10499	34943140
Weight bearing difficulty	35.86	33.60	10	3282	1085	34952554
Sedation	35.47	33.60	23	3269	20983	34932656
Prescribed overdose	35.03	33.60	18	3274	10629	34943010
Delusion	34.88	33.60	19	3273	12616	34941023
Dyslipidaemia	34.69	33.60	16	3276	7472	34946167

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	518.56	29.82	138	4133	22541	79717576
Weight increased	244.90	29.82	163	4108	277223	79462894
Neuroleptic malignant syndrome	149.44	29.82	56	4215	27503	79712614
Akathisia	126.19	29.82	41	4230	13218	79726899
Antipsychotic drug level below therapeutic	71.87	29.82	16	4255	1222	79738895
Suicide attempt	68.53	29.82	47	4224	82885	79657232
Muscle rigidity	67.99	29.82	29	4242	19853	79720264
Cervix neoplasm	65.69	29.82	11	4260	182	79739935
Disinhibition	60.09	29.82	16	4255	2582	79737535
Emotional poverty	60.02	29.82	13	4258	874	79739243
Therapeutic product effect variable	59.19	29.82	15	4256	1994	79738123
Hallucination, auditory	54.08	29.82	25	4246	20668	79719449
Tardive dyskinesia	51.90	29.82	20	4251	10551	79729566
Peptostreptococcus infection	51.42	29.82	8	4263	81	79740036
Blood pressure measurement	50.25	29.82	10	4261	443	79739674
Obsessive-compulsive disorder	47.07	29.82	16	4255	5911	79734206
Euphoric mood	46.61	29.82	17	4254	7709	79732408
Treatment noncompliance	46.44	29.82	31	4240	52237	79687880
Catatonia	44.54	29.82	17	4254	8739	79731378
Intentional self-injury	43.48	29.82	25	4246	32394	79707723
Parkinsonism	43.22	29.82	20	4251	16564	79723553
Salivary hypersecretion	42.91	29.82	19	4252	14205	79725912
Leukopenia	42.57	29.82	41	4230	116472	79623645
Persecutory delusion	41.94	29.82	14	4257	4895	79735222
Central obesity	41.46	29.82	11	4260	1750	79738367
Sedation	39.53	29.82	28	4243	51867	79688250
Delusion	39.26	29.82	20	4251	20403	79719714
Hyperthermia	38.61	29.82	19	4252	18018	79722099
Increased appetite	36.13	29.82	16	4255	11962	79728155
Coma	34.11	29.82	34	4237	100615	79639502
Injection site erosion	34.04	29.82	6	4265	136	79739981
Obesity	34.03	29.82	22	4249	35103	79705014
Dyslipidaemia	33.37	29.82	15	4256	11618	79728499
Pancreatitis necrotising	32.80	29.82	11	4260	3897	79736220
Dystonia	32.75	29.82	18	4253	21381	79718736
Incorrect route of product administration	31.70	29.82	21	4250	34908	79705209
Weight bearing difficulty	30.78	29.82	10	4261	3211	79736906

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
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
52919	PUBCHEM_CID
918	INN_ID
3559	PUBCHEM_CID
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	50458-253	INJECTION	50 mg	INTRAMUSCULAR	NDA	23 sections
Haldol Decanoate	HUMAN PRESCRIPTION DRUG LABEL	1	50458-254	INJECTION	100 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	67457-381	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	67457-382	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	67457-409	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	67457-410	INJECTION	50 mg	INTRAMUSCULAR	ANDA	14 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