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

Stem definition	Drug id	CAS RN
prednisone and prednisolone derivatives	2253	53-03-2

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: prednisone anhydrous prednisone 1,2-dehydrocortisone dehydrocortisone	A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver. Molecular weight: 358.43 Formula: C21H26O5 CLOGP: 1.66 LIPINSKI: 0 HAC: 5 HDO: 2 TPSA: 91.67 ALOGS: -3.51 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

prednisone anhydrous
prednisone
1,2-dehydrocortisone
dehydrocortisone

A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.

Molecular weight: 358.43
Formula: C21H26O5
CLOGP: 1.66
LIPINSKI: 0
HAC: 5
HDO: 2
TPSA: 91.67
ALOGS: -3.51
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
10	mg	O

ADMET properties:

Show entries

Search:

Property	Value	Reference
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	7.97 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	3 %	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	2.90 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	0.57 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.27 %	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.12 mg/mL	Bocci G, Oprea TI, Benet LZ

Showing 1 to 9 of 9 entries

Previous1Next

Approvals:

Date	Agency	Company	Orphan
Feb. 21, 1955	FDA

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
Rheumatoid arthritis	1901.88	11.41	7742	870364	246077	62364839
Completed suicide	1613.56	11.41	101	878005	145572	62465344
Drug ineffective	1499.44	11.41	21444	856662	1023321	61587595
Death	971.32	11.41	2356	875750	372025	62238891
Toxicity to various agents	957.45	11.41	1208	876898	246042	62364874
Joint swelling	827.38	11.41	7524	870582	320142	62290774
Contraindicated product administered	767.97	11.41	5398	872708	212250	62398666
Intentional overdose	697.97	11.41	98	878008	74054	62536862
Systemic lupus erythematosus	663.28	11.41	5053	873053	203865	62407051
Treatment failure	641.29	11.41	4831	873275	194212	62416704

Showing 1 to 10 of 1,255 entries

Previous1 2 3 4 5…126Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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
Off label use	895.13	11.68	8075	397230	411449	34140177
Colitis ulcerative	856.61	11.68	1007	404298	15513	34536113
Drug abuse	841.42	11.68	86	405219	99010	34452616
Drug ineffective	783.44	11.68	8401	396904	448350	34103276
Asthma	745.37	11.68	1575	403730	41081	34510545
Completed suicide	683.40	11.68	151	405154	98017	34453609
Condition aggravated	550.13	11.68	3962	401343	188234	34363392
Wheezing	526.88	11.68	1350	403955	40052	34511574
Therapeutic product effect incomplete	490.32	11.68	1493	403812	49048	34502578
Nocardiosis	489.06	11.68	389	404916	3562	34548064

Showing 1 to 10 of 1,098 entries

Previous1 2 3 4 5…110Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
Completed suicide	2353.84	11.14	250	1051055	245517	78447566
Drug ineffective	2027.00	11.14	22429	1028876	1058484	77634599
Rheumatoid arthritis	1571.17	11.14	6167	1045138	202303	78490780
Drug abuse	1430.18	11.14	218	1051087	162473	78530610
Off label use	1410.64	11.14	18178	1033127	889037	77804046
Toxicity to various agents	1355.01	11.14	2167	1049138	419373	78273710
Colitis ulcerative	1216.84	11.14	1868	1049437	32874	78660209
Condition aggravated	1078.32	11.14	10709	1040596	490415	78202668
Death	1051.23	11.14	3884	1047421	562630	78130453
Asthma	954.13	11.14	3918	1047387	131177	78561906

Showing 1 to 10 of 1,691 entries

Previous1 2 3 4 5…170Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	A07EA03	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFLAMMATORY AGENTS Corticosteroids acting locally
ATC	H02AB07	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CORTICOSTEROIDS FOR SYSTEMIC USE CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN Glucocorticoids
CHEBI has role	CHEBI:35472	anti-inflammatory drugs
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:37962	adrenergic agents
CHEBI has role	CHEBI:50266	Prodrugs
FDA EPC	N0000175576	Corticosteroid
FDA MoA	N0000175450	Corticosteroid Hormone Receptor Agonists
MeSH PA	D000893	Anti-Inflammatory Agents

Showing 1 to 10 of 14 entries

Previous1 2Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
Disorder of musculoskeletal system	indication	928000	DOID:17
Berylliosis	indication	8247009	DOID:10322
Psoriasis	indication	9014002	DOID:8893
Ankylosing spondylitis	indication	9631008	DOID:7147
Rheumatic heart disease	indication	23685000
Atopic dermatitis	indication	24079001	DOID:3310
Inflammatory bowel disease	indication	24526004	DOID:0050589
Multiple sclerosis	indication	24700007	DOID:2377
Sarcoidosis	indication	31541009	DOID:11335
Idiopathic thrombocytopenic purpura	indication	32273002	DOID:8924

Showing 1 to 10 of 121 entries

Previous1 2 3 4 5…13Next

🐶 Veterinary Drug Use

Species	Use	Relation
Cats	Inflammation	Indication
Dogs	Inflammation	Indication
Horses	Inflammation	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Meticorten	Intervet Inc.	1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.33	acidic

Orange Book patent data (new drug applications)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	8309124	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG PREDNISONE TABLET
1MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	8394407	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
1MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9040085	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
1MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9186332	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
1MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9504699	Aug. 3, 2027	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
2MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	8394407	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
2MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9040085	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
2MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9186332	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
2MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	9504699	Aug. 3, 2027	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
5MG	RAYOS	HORIZON	N202020	July 26, 2012	RX	TABLET, DELAYED RELEASE	ORAL	8309124	April 23, 2024	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG PREDNISONE TABLET

Showing 1 to 10 of 15 entries

Previous1 2Next

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Show entries

Search:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN	AGONIST	EC50	8	WOMBAT-PK	CHEMBL
Sodium/nucleoside cotransporter 1	Transporter	O00337	S28A1_HUMAN		Ki	5.77	DRUG MATRIX
Annexin A1	Cytosolic other	P04083	ANXA1_HUMAN				WOMBAT-PK

Showing 1 to 3 of 3 entries

Previous1Next

External reference:

Show entries

Search:

ID	Source
PDN	PDB_CHEM_ID
002164	NDDF
10312003	SNOMEDCT_US
116602009	SNOMEDCT_US
287	MMSL
4017876	VUID
4017876	VANDF
5351	MMSL
536	INN_ID
5865	PUBCHEM_CID

Showing 1 to 10 of 22 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0017	TABLET	10 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0017	TABLET	10 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0017	TABLET	10 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0018	TABLET	20 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0018	TABLET	20 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0018	TABLET	20 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0019	TABLET	50 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0019	TABLET	50 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0019	TABLET	50 mg	ORAL	ANDA	10 sections
PredniSONE	HUMAN PRESCRIPTION DRUG LABEL	1	0054-3722	SOLUTION	5 mg	ORAL	ANDA	10 sections

Showing 1 to 10 of 30 entries

Previous1 2 3Next