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

Stem definition	Drug id	CAS RN
	2029	76-42-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: oxycontin oxycodone dihydro-14-hydroxycodeinone dihydrohydroxycodeinone dihydrone oxicon oxycodeinone oxymorphone 3-methyl ether oxynorm oxycodone hydrochloride oxycodone terephthalate oxycodone hydrochloride hydrate oxycodone HCl	A semisynthetic derivative of CODEINE. Molecular weight: 315.37 Formula: C18H21NO4 CLOGP: -0.04 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 59 ALOGS: -1.75 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

oxycontin
oxycodone
dihydro-14-hydroxycodeinone
dihydrohydroxycodeinone
dihydrone
oxicon
oxycodeinone
oxymorphone 3-methyl ether
oxynorm
oxycodone hydrochloride
oxycodone terephthalate
oxycodone hydrochloride hydrate
oxycodone HCl

A semisynthetic derivative of CODEINE.

Molecular weight: 315.37
Formula: C18H21NO4
CLOGP: -0.04
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 59
ALOGS: -1.75
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
75	mg	O
30	mg	P
75	mg	O

ADMET properties:

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Property	Value	Reference
CL (Clearance)	6.10 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	5.50 hours	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	42 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.50 L/kg	Lombardo F, Berellini G, Obach RS
EoM (Fraction excreted unchanged in urine)	19 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	166.67 mg/mL	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.06 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.55 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
April 12, 1950	FDA	ENDO PHARMS
Oct. 29, 2020	PMDA	SHIONOGI PHARMA CO., LTD

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
Drug abuse	1575.96	9.75	1891	320248	70627	63096256
Completed suicide	1359.56	9.75	2556	319583	143117	63023766
Drug abuser	1270.62	9.75	499	321640	2424	63164459
Muscle injury	1037.83	9.75	1460	320679	63885	63102998
Folliculitis	1031.73	9.75	1513	320626	68804	63098079
Drug dependence	1013.38	9.75	903	321236	23580	63143303
Irritable bowel syndrome	968.73	9.75	1601	320538	80811	63086072
Lower respiratory tract infection	800.02	9.75	1947	320192	130360	63036523
Impaired healing	782.41	9.75	1655	320484	100887	63065996
Respiratory arrest	764.51	9.75	885	321254	31760	63135123

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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	2214.35	10.45	2701	186490	96395	34671345
Drug abuser	2145.41	10.45	807	188384	3147	34764593
Drug dependence	1789.89	10.45	1288	187903	22929	34744811
Toxicity to various agents	987.91	10.45	2841	186350	197521	34570219
Respiratory arrest	898.40	10.45	924	188267	27119	34740621
Completed suicide	826.21	10.45	1712	187479	96456	34671284
Drug withdrawal syndrome	824.26	10.45	754	188437	19080	34748660
Overdose	810.04	10.45	1625	187566	89434	34678306
Accidental overdose	764.45	10.45	728	188463	19412	34748328
Substance abuse	632.75	10.45	436	188755	7205	34760535

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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	3695.11	9.78	4318	397091	158373	79184606
Completed suicide	2415.89	9.78	4387	397022	241380	79101599
Respiratory arrest	1900.80	9.78	1865	399544	55685	79287294
Toxicity to various agents	1687.09	9.78	5301	396108	416239	78926740
Drug abuser	1510.70	9.78	694	400715	5319	79337660
Drug dependence	1273.42	9.78	1282	400127	39487	79303492
Overdose	1146.03	9.78	2727	398682	181479	79161500
Accidental overdose	1008.88	9.78	1117	400292	38464	79304515
Drug withdrawal syndrome	940.98	9.78	1012	400397	33706	79309273
Cardio-respiratory arrest	825.19	9.78	1741	399668	106769	79236210

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02AA05	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA55	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA56	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AJ17	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ18	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
ATC	N02AJ19	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with non-opioid analgesics
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:51177	anti-tussive
CHEBI has role	CHEBI:55322	mu-opioid agonists
FDA EPC	N0000175690	Opioid Agonist

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

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Disease	Relation	SNOMED_ID
Severe pain	indication	76948002
Acute postoperative pain	indication	107401000119105
Chronic Pain with Opioid Tolerance	indication
Neuropathic pain	off-label use	247398009
Hypophosphatemia	contraindication	4996001
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcoholism	contraindication	7200002
Alcohol withdrawal delirium	contraindication	8635005
Asthenia	contraindication	13791008

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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	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
1.2MG;10MG	TROXYCA ER	PFIZER	N207621	Aug. 19, 2016	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8685443	July 3, 2025	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS CLAIMED
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	10130591	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8309060	Nov. 20, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	11304909	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	8808741	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492391	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG	OXYCONTIN	PURDUE PHARMA LP	N022272	April 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	9492393	Aug. 24, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9555000	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
10MG;20MG	TARGINIQ	PURDUE PHARMA LP	N205777	July 23, 2014	DISCN	TABLET, EXTENDED RELEASE	ORAL	9907793	April 4, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
13.5MG	XTAMPZA ER	COLLEGIUM PHARM INC	N208090	April 26, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	10525052	July 7, 2023	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

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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	7.80	WOMBAT-PK	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		EC50	4.80	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		EC50	5.40	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_RAT		Ki	7.36	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_MOUSE		EC50	6.80	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	5.96	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	6.49	CHEMBL
Acetylcholinesterase	Enzyme		ACES_ELEEL		IC50	4.12	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Ki	5.58	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_MOUSE		EC50	4.80	CHEMBL

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External reference:

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ID	Source
OOX	PDB_CHEM_ID
001558	NDDF
001559	NDDF
004513	NDDF
10664	MMSL
116352007	SNOMEDCT_US
124-90-3	SECONDARY_CAS_RN
124133-68-2	SECONDARY_CAS_RN
159821	RXNORM
1701	INN_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
oxycodone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0390	SOLUTION	5 mg	ORAL	ANDA	32 sections
oxycodone hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0390	SOLUTION	5 mg	ORAL	ANDA	32 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5731	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5731	TABLET, FILM COATED, EXTENDED RELEASE	10 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5732	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5732	TABLET, FILM COATED, EXTENDED RELEASE	20 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5733	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5733	TABLET, FILM COATED, EXTENDED RELEASE	40 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5734	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	NDA authorized generic	33 sections
Oxycodone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5734	TABLET, FILM COATED, EXTENDED RELEASE	80 mg	ORAL	NDA authorized generic	33 sections

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