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

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists, morphinan derivates	2034	76-41-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxymorphone 14-Hydroxydihydromorphinone (-)-Oxymorphone oxymorphone hydrochloride oxymorphone HCl	An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092) Molecular weight: 301.34 Formula: C17H19NO4 CLOGP: -0.48 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 70 ALOGS: -1.07 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxymorphone
14-Hydroxydihydromorphinone
(-)-Oxymorphone
oxymorphone hydrochloride
oxymorphone HCl

An opioid analgesic with actions and uses similar to those of MORPHINE, apart from an absence of cough suppressant activity. It is used in the treatment of moderate to severe pain, including pain in obstetrics. It may also be used as an adjunct to anesthesia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1092)

Molecular weight: 301.34
Formula: C17H19NO4
CLOGP: -0.48
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 70
ALOGS: -1.07
ROTB: 0

Status: OFP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
S (Water solubility)	24 mg/mL	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	10 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
EoM (Fraction excreted unchanged in urine)	1.90 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
April 2, 1959	FDA	ENDO PHARMS

FDA Adverse Event Reporting System (Female)

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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
Toxicity to various agents	227.62	27.65	137	2576	247113	63239196
Drug abuse	224.52	27.65	92	2621	72426	63413883
Completed suicide	188.35	27.65	101	2612	145572	63340737
Drug use disorder	113.87	27.65	29	2684	4955	63481354
Intentional product misuse	94.88	27.65	48	2665	60869	63425440
Respiratory arrest	69.82	27.65	32	2681	32613	63453696
Injection site abscess	64.64	27.65	14	2699	1184	63485125
Cardio-respiratory arrest	61.91	27.65	36	2677	59923	63426386
Staphylococcal bacteraemia	55.98	27.65	17	2696	5513	63480796
Accidental poisoning	55.22	27.65	11	2702	617	63485692

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FDA Adverse Event Reporting System (Male)

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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
Drug abuse	285.18	37.27	130	1896	98966	34855939
Toxicity to various agents	209.14	37.27	134	1892	200228	34754677
Drug use disorder	124.68	37.27	32	1994	4159	34950746
Drug dependence	102.56	37.27	42	1984	24175	34930730
Completed suicide	97.44	37.27	64	1962	98104	34856801
Intentional product misuse	94.31	37.27	48	1978	45563	34909342
Accidental overdose	75.36	37.27	32	1994	20108	34934797
Drug withdrawal syndrome	72.51	37.27	31	1995	19803	34935102
Injection site abscess	70.90	37.27	15	2011	834	34954071
Intentional product use issue	66.60	37.27	42	1984	59774	34895131

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FDA Adverse Event Reporting System (Geriatric)

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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
Drug abuse	471.87	27.33	204	3675	162487	79578022
Toxicity to various agents	433.72	27.33	262	3617	421278	79319231
Completed suicide	280.46	27.33	164	3715	245603	79494906
Drug use disorder	238.48	27.33	60	3819	8591	79731918
Intentional product misuse	185.64	27.33	91	3788	95074	79645435
Injection site abscess	142.17	27.33	29	3850	1611	79738898
Intentional product use issue	113.76	27.33	78	3801	152034	79588475
Injection site cellulitis	106.90	27.33	23	3856	1655	79738854
Endocarditis	100.75	27.33	32	3847	10565	79729944
Respiratory arrest	100.12	27.33	51	3828	57499	79683010

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02AA11	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
FDA EPC	N0000175690	Opioid Agonist
FDA MoA	N0000175684	Full Opioid Agonists
MeSH PA	D000759	Adjuvants, Anesthesia
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D002491	Central Nervous System Agents
MeSH PA	D002492	Central Nervous System Depressants
MeSH PA	D009294	Narcotics
MeSH PA	D018373	Peripheral Nervous System Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID
Pain	indication	22253000
General anesthesia	indication	50697003
Severe pain	indication	76948002
Chronic pain	indication	82423001
Labor pain	indication	247412007
Local anesthesia	indication	386761002
Severe Pain with Opioid Tolerance	indication
Chronic Pain with Opioid Tolerance	indication
Anxiety due to Cardiac Asthma	indication
Suicidal thoughts	contraindication	6471006

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.31	acidic
pKa2	7.97	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
10MG	OPANA ER	ENDO PHARMS	N201655	Dec. 9, 2011	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	DOSE MODIFICATION FOR RENAL IMPAIRMENT
15MG	OPANA ER	ENDO PHARMS	N201655	Dec. 9, 2011	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	Feb. 29, 2008	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	Feb. 29, 2008	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	DOSE MODIFICATION FOR RENAL IMPAIRMENT
20MG	OPANA ER	ENDO PHARMS	N201655	Dec. 9, 2011	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	7276250	Feb. 4, 2023	RELIEF OF MODERATE TO SEVERE PAIN
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OPANA ER	ENDO PHARMS	N021610	June 22, 2006	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	DOSE MODIFICATION FOR RENAL IMPAIRMENT
30MG	OPANA ER	ENDO PHARMS	N201655	Dec. 9, 2011	DISCN	TABLET, EXTENDED RELEASE	ORAL	8808737	June 21, 2027	METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	9.44	WOMBAT-PK	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN	AGONIST	Ki	6.83	WOMBAT-PK	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN	AGONIST	Ki	7.30	CHEMBL	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	9.01	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_MOUSE		Ki	8.30	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_CAVPO		Ki	9.27	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_MOUSE		Ki	6.21	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	7.09	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	7.24	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Ki	7.02	CHEMBL

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External reference:

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ID	Source
001548	NDDF
004623	NDDF
177273	MMSL
24751001	SNOMEDCT_US
357-07-3	SECONDARY_CAS_RN
370266008	SNOMEDCT_US
4019062	VANDF
4019871	VUID
4019871	VANDF
5220	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
OPANA	HUMAN PRESCRIPTION DRUG LABEL	1	16590-765	TABLET	10 mg	ORAL	NDA	30 sections
OPANAER	HUMAN PRESCRIPTION DRUG LABEL	1	16590-609	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA	18 sections
OPANAER	HUMAN PRESCRIPTION DRUG LABEL	1	16590-747	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA	18 sections
OPANAER	HUMAN PRESCRIPTION DRUG LABEL	1	16590-767	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	18 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0283	TABLET	5 mg	ORAL	ANDA	33 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0283	TABLET	5 mg	ORAL	ANDA	33 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0283	TABLET	5 mg	ORAL	ANDA	33 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0284	TABLET	10 mg	ORAL	ANDA	33 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0284	TABLET	10 mg	ORAL	ANDA	33 sections
Oxymorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0284	TABLET	10 mg	ORAL	ANDA	33 sections

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