prednisone indications/contra

Stem definitionDrug idCAS RN
prednisone and prednisolone derivatives 2253 53-03-2

Description:

MoleculeDescription

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

Drug dosage:

DoseUnitRoute
10 mg O

Approvals:

DateAgencyCompanyOrphan
Feb. 21, 1955 FDA

FDA Adverse Event Reporting System

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MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Febrile neutropenia 3910.29 17.25 1252 24049 17723 3342835
Neutropenia 2186.07 17.25 951 24350 32435 3328123
Pyrexia 1961.64 17.25 1178 24123 79937 3280621
Pneumonia 1949.18 17.25 1115 24186 69028 3291530
Drug ineffective 1921.74 17.25 1327 23974 114763 3245795
Sepsis 1831.67 17.25 833 24468 31540 3329018
Infection 1694.38 17.25 734 24567 24668 3335890
Anaemia 1504.18 17.25 863 24438 53470 3307088
Thrombocytopenia 1335.51 17.25 690 24611 34578 3325980
Septic shock 1224.68 17.25 473 24828 11711 3348847
Disease progression 1208.98 17.25 627 24674 31632 3328926
Fatigue 1082.57 17.25 916 24385 106324 3254234
Respiratory failure 1058.06 17.25 515 24786 22626 3337932
Diarrhoea 1042.09 17.25 886 24415 103462 3257096
Leukopenia 1003.54 17.25 442 24859 15381 3345177
Pneumocystis jirovecii pneumonia 972.36 17.25 297 25004 3493 3357065
Diabetes mellitus 961.55 17.25 397 24904 11736 3348822
Condition aggravated 915.02 17.25 559 24742 38674 3321884
Death 912.98 17.25 975 24326 151349 3209209
Rheumatoid arthritis 905.71 17.25 410 24891 15228 3345330
Cytomegalovirus infection 893.13 17.25 290 25011 4217 3356341
Haematotoxicity 862.15 17.25 239 25062 1935 3358623
Off label use 855.83 17.25 604 24697 53373 3307185
Post transplant lymphoproliferative disorder 827.44 17.25 188 25113 580 3359978
Pain 817.62 17.25 658 24643 70899 3289659
Multiple organ dysfunction syndrome 815.99 17.25 372 24929 14038 3346520
Pancytopenia 797.56 17.25 398 24903 18422 3342136
Nausea 782.79 17.25 834 24467 128811 3231747
Acute myeloid leukaemia 752.92 17.25 264 25037 4909 3355649
Dyspnoea 751.37 17.25 734 24567 102200 3258358

Pharmacologic Action:

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SourceCodeDescription
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
MeSH PA D000305 Adrenal Cortex Hormones
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D005938 Glucocorticoids
MeSH PA D006728 Hormones
MeSH PA D006730 Hormones, Hormone Substitutes, and Hormone Antagonists
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:35472 anti-inflammatory drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:37962 adrenergic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
FDA EPC N0000175576 Corticosteroid
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
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:13404
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001 DOID:9008
Crohn's disease indication 34000006
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Angioedema indication 41291007 DOID:1558
Humoral hypercalcemia of malignancy indication 47709007
Articular gout indication 48440001 DOID:13189
Edema of larynx indication 51599000
Nephrotic syndrome indication 52254009 DOID:1184
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Löffler's syndrome indication 64936001 DOID:9503
Pemphigus indication 65172003 DOID:9182
Rheumatoid arthritis indication 69896004 DOID:7148
Transfusion reaction due to serum protein reaction indication 72284000
Epicondylitis indication 73583000 DOID:14087
Acquired thrombocytopenia indication 74576004 DOID:11126
Thyroiditis indication 82119001 DOID:7166
Autoimmune disease indication 85828009
Infection by larvae of Trichinella spiralis indication 88264003 DOID:9784
Congenital hypoplastic anemia indication 88854002 DOID:1342
Acute lymphoid leukemia indication 91857003 DOID:9952
Chronic lymphoid leukemia, disease indication 92814006 DOID:1040
Disorder of skin indication 95320005 DOID:37
Diffuse non-Hodgkin's lymphoma, large cell indication 109969005
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009 DOID:8651
Non-Hodgkin's lymphoma indication 118601006 DOID:8675
Mycosis fungoides indication 118618005 DOID:8691
Asthma indication 195967001 DOID:2841
Transplanted organ rejection indication 213148006
Adrenogenital disorder indication 267395000 DOID:0050811
Exacerbation of asthma indication 281239006
Follicular non-Hodgkin's lymphoma indication 308121000
Primary adrenocortical insufficiency indication 373662000 DOID:13774
Adrenal cortical hypofunction indication 386584007 DOID:10493
Erythroderma indication 399992009
Primary cutaneous T-cell lymphoma indication 400122007
Juvenile rheumatoid arthritis indication 410795001
Autoimmune hemolytic anemia indication 413603009 DOID:718
Prevention of Transplant Rejection indication
Systemic Dermatomyositis indication
Erythroblastic Anemia indication
Diffuse Proliferative Lupus Nephritis indication
Infection by Strongyloides contraindication 1214006 DOID:10955
Mycosis contraindication 3218000 DOID:1564
Gastritis contraindication 4556007 DOID:4029
Inactive tuberculosis contraindication 11999007
Peptic ulcer contraindication 13200003 DOID:750
Hypercholesterolemia contraindication 13644009
Measles contraindication 14189004 DOID:8622
Cirrhosis of liver contraindication 19943007 DOID:5082
Arginase deficiency contraindication 23501004 DOID:9278
Immunosuppression contraindication 38013005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Cerebral malaria contraindication 53622003 DOID:14069
Tuberculosis contraindication 56717001
Congenital hyperammonemia, type I contraindication 62522004 DOID:9280
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Hyperglycemia contraindication 80394007 DOID:4195
Open-angle glaucoma contraindication 84494001 DOID:1067
Muscle atrophy contraindication 88092000 DOID:767
Herpes simplex contraindication 88594005 DOID:8566
Bilateral cataracts contraindication 95722004
Seizure disorder contraindication 128613002 DOID:1826
Disorder of muscle contraindication 129565002 DOID:423
Ophthalmic herpes simplex contraindication 186542001
Anastomosis of intestine contraindication 235407009
Edema contraindication 267038008
Pathological fracture contraindication 268029009
Diverticulitis of gastrointestinal tract contraindication 271366000
Cerebral trauma contraindication 275382005
Pregnancy, function contraindication 289908002
Varicella-zoster virus infection contraindication 309465005
Osteopenia contraindication 312894000
Avascular necrosis of bone contraindication 397758007 DOID:10159
Citrullinemia contraindication 398680004 DOID:9273
Traumatic rupture of tendon contraindication 415749005
Exposure to varicella contraindication 444453009
Ornithine Carbamyltransferase Deficiency contraindication
Arginosuccinate Lyase Deficiency contraindication
Pericarditis off-label use 3238004 DOID:1787
Chronic obstructive lung disease off-label use 13645005 DOID:3083
West syndrome off-label use 28055006 DOID:2481
Vasculitis off-label use 31996006 DOID:865
Nasal polyp off-label use 52756005
Rheumatic fever off-label use 58718002 DOID:1586
Pseudogout off-label use 60782007 DOID:1156
Polymyalgia rheumatica off-label use 65323003 DOID:853
Pemphigoid off-label use 86142006 DOID:8506
Myasthenia gravis off-label use 91637004 DOID:437
Multiple myeloma off-label use 109989006 DOID:9538
Polyarteritis nodosa off-label use 155441006 DOID:9810
Bell's palsy off-label use 193093009 DOID:12506
Celiac disease off-label use 396331005 DOID:10608
Carditis off-label use 399617002
Giant cell arteritis off-label use 414341000 DOID:13375
Pure Red Cell Aplasia associated with Chronic Lymphocytic Leukemia off-label use
Neuroendocrine Prostate Carcinoma off-label use
Cluster Headache Prevention off-label use
Metastatic Prostate Carcinoma off-label use
Hypercalcemia associated with Sarcoidosis off-label use
Prevention of Cardiac Transplant Rejection off-label use
Prevention of Lung Transplant Rejection off-label use

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.33 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1MG RAYOS HORIZON PHARMA N202020 July 26, 2012 RX TABLET, DELAYED RELEASE ORAL 6488960 March 14, 2020 TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF PREDNISONE
1MG RAYOS HORIZON PHARMA N202020 July 26, 2012 RX TABLET, DELAYED RELEASE ORAL 6677326 March 14, 2020 TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
2MG RAYOS HORIZON PHARMA N202020 July 26, 2012 RX TABLET, DELAYED RELEASE ORAL 6488960 March 14, 2020 TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF PREDNISONE
2MG RAYOS HORIZON PHARMA N202020 July 26, 2012 RX TABLET, DELAYED RELEASE ORAL 6677326 March 14, 2020 TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
1MG RAYOS HORIZON PHARMA 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 PHARMA 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 PHARMA 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 PHARMA 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 PHARMA 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 PHARMA 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 PHARMA 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
5MG RAYOS HORIZON PHARMA 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
5MG RAYOS HORIZON PHARMA 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
5MG RAYOS HORIZON PHARMA 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
5MG RAYOS HORIZON PHARMA 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 PHARMA 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 PHARMA 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 PHARMA 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 PHARMA N202020 July 26, 2012 RX TABLET, DELAYED RELEASE ORAL 8168218 Jan. 7, 2028 TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY, GASTROINTESTINAL, DERMATOLOGIC DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 8 WOMBAT-PK CHEMBL
Sodium/nucleoside cotransporter 1 Transporter Ki 5.77 DRUG MATRIX
Annexin A1 Cytosolic other WOMBAT-PK

External reference:

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IDSource
4017876 VUID
N0000146229 NUI
C0032952 UMLSCUI
7096 IUPHAR_LIGAND_ID
D00473 KEGG_DRUG
CHEMBL635 ChEMBL_ID
DB00635 DRUGBANK_ID
4017876 VANDF
287 MMSL
8640 RXNORM
116602009 SNOMEDCT_US
5351 MMSL
d00350 MMSL
10312003 SNOMEDCT_US
N0000006687 NDFRT
N0000146229 NDFRT
002164 NDDF
5865 PUBCHEM_CID
D011241 MESH_DESCRIPTOR_UI
VB0R961HZT UNII
536 INN_ID
CHEBI:8382 CHEBI

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-0017 TABLET 10 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-0018 TABLET 20 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-0019 TABLET 50 mg ORAL ANDA 12 sections
PredniSONE Intensol HUMAN PRESCRIPTION DRUG LABEL 1 0054-3721 SOLUTION, CONCENTRATE 5 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-3722 SOLUTION 5 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4728 TABLET 5 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4741 TABLET 1 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-4742 TABLET 2.50 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-8724 TABLET 5 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-8739 TABLET 1 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0054-8740 TABLET 2.50 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0143-9738 TABLET 20 mg ORAL ANDA 10 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0143-9739 TABLET 10 mg ORAL ANDA 10 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0143-9740 TABLET 5 mg ORAL ANDA 10 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0440-8165 TABLET 5 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0440-8167 TABLET 20 mg ORAL ANDA 11 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0463-6141 TABLET 20 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0463-6155 TABLET 5 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0591-5052 TABLET 5 mg ORAL ANDA 11 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0591-5442 TABLET 10 mg ORAL ANDA 11 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0591-5443 TABLET 20 mg ORAL ANDA 11 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5335 TABLET 1 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5336 TABLET 2.50 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5337 TABLET 5 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5338 TABLET 10 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0603-5339 TABLET 20 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0615-0536 TABLET 5 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0615-1542 TABLET 20 mg ORAL ANDA 12 sections
PredniSONE HUMAN PRESCRIPTION DRUG LABEL 1 0615-2513 TABLET 2.50 mg ORAL ANDA 12 sections
Prednisone HUMAN PRESCRIPTION DRUG LABEL 1 0615-3593 TABLET 10 mg ORAL ANDA 12 sections