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

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists, morphinan derivates	1845	57-27-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: morphine hydrochloride morphine morphin morphina morphine sulfate morphine liposomal morphine sulfate hydrate morphine HCl	The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle. Molecular weight: 285.34 Formula: C17H19NO3 CLOGP: 0.57 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 52.93 ALOGS: -1.45 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

morphine hydrochloride
morphine
morphin
morphina
morphine sulfate
morphine liposomal
morphine sulfate hydrate
morphine HCl

The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle.

Molecular weight: 285.34
Formula: C17H19NO3
CLOGP: 0.57
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 52.93
ALOGS: -1.45
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.10	g	O
30	mg	P
30	mg	R

ADMET properties:

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Property	Value	Reference
S (Water solubility)	57.14 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.85 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	4 %	Benet LZ, Broccatelli F, Oprea TI
CL (Clearance)	26 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	24 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	2.30 L/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2 hours	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.65 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
None	FDA

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 hypersensitivity	6611.40	9.57	6593	209156	304094	62969179
Drug abuse	1097.64	9.57	1292	214457	71226	63202047
Toxicity to various agents	956.42	9.57	2392	213357	244858	63028415
Sedation	475.19	9.57	622	215127	38187	63235086
Depressed level of consciousness	467.49	9.57	792	214957	61286	63211987
Overdose	453.96	9.57	1123	214626	113955	63159318
Death	446.98	9.57	2474	213275	371907	62901366
Respiratory depression	443.40	9.57	370	215379	13345	63259928
Constipation	395.91	9.57	1663	214086	223280	63049993
Respiratory arrest	382.35	9.57	512	215237	32133	63241140

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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
Toxicity to various agents	1660.28	10.46	2936	139093	197426	34617476
Drug abuse	1365.86	10.46	1840	140189	97256	34717646
Drug hypersensitivity	1207.57	10.46	1559	140470	78970	34735932
Respiratory depression	708.56	10.46	562	141467	15683	34799219
Overdose	644.56	10.46	1250	140779	89809	34725093
Drug dependence	507.75	10.46	557	141472	23660	34791242
Accidental overdose	406.23	10.46	454	141575	19686	34795216
Miosis	359.21	10.46	303	141726	9232	34805670
Substance abuse	292.33	10.46	245	141784	7396	34807506
Somnolence	277.21	10.46	1036	140993	110080	34704822

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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 hypersensitivity	5782.30	9.69	6342	294604	292574	79150868
Drug abuse	2392.28	9.69	3006	297940	159685	79283757
Toxicity to various agents	2339.67	9.69	5003	295943	416537	79026905
Respiratory depression	1032.40	9.69	847	300099	26783	79416659
Overdose	918.97	9.69	2099	298847	182107	79261335
Accidental overdose	701.02	9.69	805	300141	38776	79404666
Sedation	667.71	9.69	899	300047	50996	79392446
Death	651.44	9.69	4003	296943	562511	78880931
Depressed level of consciousness	649.49	9.69	1245	299701	95407	79348035
Miosis	621.38	9.69	499	300447	15290	79428152

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A07DA52	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS ANTIPROPULSIVES Antipropulsives
ATC	N02AA01	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA51	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AG01	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with antispasmodics
ATC	R05DA05	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS Opium alkaloids and derivatives
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:35620	vasodilator agents
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:38867	anaesthetic
CHEBI has role	CHEBI:55322	mu-opioid agonists

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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
Diarrhea	indication	62315008
Severe pain	indication	76948002
Chronic pain	indication	82423001
Local anesthesia	indication	386761002
Acute postoperative pain	indication	107401000119105
Regional Anesthesia for Surgery	indication
Regional Anesthesia for Labor Pain	indication
Chronic Pain with Opioid Tolerance	indication

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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	9.71	acidic
pKa2	8.38	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
100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	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
100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	7682633	June 19, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8158156	June 19, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	8623418	Nov. 7, 2029	TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED
10MG/ML (10MG/ML)	MORPHINE SULFATE	FRESENIUS KABI USA	N204223	Oct. 30, 2013	RX	SOLUTION	INTRAMUSCULAR, INTRAVENOUS	9192608	March 12, 2034	MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
10MG/ML (10MG/ML)	MORPHINE SULFATE	FRESENIUS KABI USA	N204223	Oct. 30, 2013	RX	SOLUTION	INTRAMUSCULAR, INTRAVENOUS	9192608	March 12, 2034	TREATMENT OF PAIN
15MG	ARYMO ER	ZYLA	N208603	Jan. 9, 2017	DISCN	TABLET, EXTENDED RELEASE	ORAL	9044402	July 1, 2033	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
15MG	ARYMO ER	ZYLA	N208603	Jan. 9, 2017	DISCN	TABLET, EXTENDED RELEASE	ORAL	9549899	July 1, 2033	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	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
20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	EMBEDA	ALPHARMA PHARMS	N022321	Aug. 13, 2009	DISCN	CAPSULE, EXTENDED RELEASE	ORAL	7682633	June 19, 2027	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.

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Orange Book exclusivity data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
10MG/5ML	MORPHINE SULFATE	HIKMA	N022195	March 17, 2008	RX	SOLUTION	ORAL	June 2, 2024	NEW PATIENT POPULATION
15MG	MORPHINE SULFATE	HIKMA	N022207	March 17, 2008	RX	TABLET	ORAL	June 2, 2024	NEW PATIENT POPULATION
20MG/5ML	MORPHINE SULFATE	HIKMA	N022195	March 17, 2008	RX	SOLUTION	ORAL	June 2, 2024	NEW PATIENT POPULATION
30MG	MORPHINE SULFATE	HIKMA	N022207	March 17, 2008	RX	TABLET	ORAL	June 2, 2024	NEW PATIENT POPULATION

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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	EC50	7.86	WOMBAT-PK	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		Ki	6.97	WOMBAT-PK
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	6.62	WOMBAT-PK
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	4.55	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_MOUSE		Ki	7	CHEMBL
Delta-type opioid receptor	GPCR		OPRD_RAT		Ki	8.74	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_CAVPO		Ki	7.62	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_RAT		Ki	7.57	CHEMBL
Kappa-type opioid receptor	GPCR		OPRK_MOUSE		Ki	6.52	CHEMBL
Mu-type opioid receptor	GPCR		OPRM_BOVIN		Ki	9.30	CHEMBL

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External reference:

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ID	Source
MOI	PDB_CHEM_ID
001545	NDDF
001546	NDDF
003523	NDDF
15239	MMSL
1627	IUPHAR_LIGAND_ID
18643	MMSL
1913	MMSL
235751	RXNORM
373529000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6011	CAPSULE, EXTENDED RELEASE	10 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6012	CAPSULE, EXTENDED RELEASE	20 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6013	CAPSULE, EXTENDED RELEASE	30 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6014	CAPSULE, EXTENDED RELEASE	40 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6015	CAPSULE, EXTENDED RELEASE	50 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6016	CAPSULE, EXTENDED RELEASE	60 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6017	CAPSULE, EXTENDED RELEASE	80 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6018	CAPSULE, EXTENDED RELEASE	100 mg	ORAL	NDA	34 sections
Kadian	HUMAN PRESCRIPTION DRUG LABEL	1	0023-6019	CAPSULE, EXTENDED RELEASE	200 mg	ORAL	NDA	34 sections
Morphine Sulfate	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0235	TABLET	15 mg	ORAL	NDA	32 sections

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