hydrocortisone succinate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 4456 125-04-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocortisone sodium succinate
  • hydrocortisone succinate
  • hydrocortisone hemisuccinate
  • Molecular weight: 462.54
  • Formula: C25H34O8
  • CLOGP: 2.19
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 138.20
  • ALOGS: -3.85
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 27, 1955 FDA PHARMACIA AND UPJOHN

FDA Adverse Event Reporting System (Female)

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
Infusion related reaction 399.95 14.26 264 10614 100944 46574240
Flushing 95.35 14.26 95 10783 64519 46610665
Urticaria 48.08 14.26 93 10785 117799 46557385
Febrile neutropenia 45.31 14.26 80 10798 94547 46580637
Anaphylactic shock 41.88 14.26 36 10842 20238 46654946
Disseminated intravascular coagulation 35.75 14.26 32 10846 18973 46656211
Pyrexia 35.62 14.26 168 10710 348634 46326550
Toxicity to various agents 32.99 14.26 5 10873 211761 46463423
Chest discomfort 28.34 14.26 64 10814 90205 46584979
Blood pressure fluctuation 27.99 14.26 35 10843 30413 46644771
Colitis ulcerative 27.84 14.26 27 10851 17705 46657479
Septic shock 27.75 14.26 49 10829 57844 46617340
Blood pressure decreased 26.91 14.26 48 10830 57111 46618073
Pruritus 26.36 14.26 119 10759 242233 46432951
Product use issue 25.26 14.26 63 10815 94581 46580603
Drug ineffective 25.21 14.26 78 10800 677760 45997424
Erythema 24.44 14.26 81 10797 142739 46532445
Abdominal pain 24.30 14.26 112 10766 229919 46445265
Shock 23.16 14.26 27 10851 21818 46653366
Dyspnoea 22.38 14.26 200 10678 515348 46159836
Genital rash 22.01 14.26 7 10871 477 46674707
Cytomegalovirus infection 21.92 14.26 24 10854 18120 46657064
Cytomegalovirus viraemia 20.84 14.26 13 10865 4465 46670719
Endometritis decidual 20.26 14.26 4 10874 36 46675148
Oxygen saturation decreased 19.47 14.26 47 10831 69117 46606067
Aspartate aminotransferase increased 18.54 14.26 50 10828 78650 46596534
Tracheal inflammation 18.51 14.26 4 10874 58 46675126
Platelet count decreased 18.24 14.26 58 10820 99966 46575218
Feeling hot 18.04 14.26 32 10846 37896 46637288
Apocrine miliaria 17.94 14.26 3 10875 9 46675175
Drug interaction 17.58 14.26 13 10865 203081 46472103
Neutrophil count decreased 17.35 14.26 34 10844 43392 46631792
Intestinal resection 17.19 14.26 9 10869 2221 46672963
Hypofibrinogenaemia 16.60 14.26 7 10871 1063 46674121
Heart rate increased 16.11 14.26 46 10832 74745 46600439
Bronchospasm 15.96 14.26 19 10859 15688 46659496
Adrenocortical insufficiency acute 15.26 14.26 7 10871 1299 46673885
Adrenal insufficiency 15.23 14.26 17 10861 13107 46662077
Throat tightness 14.78 14.26 21 10857 20618 46654566

FDA Adverse Event Reporting System (Male)

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
Infusion related reaction 325.84 14.90 182 8714 40382 29903200
Pyrexia 63.15 14.90 211 8685 294278 29649304
Disseminated intravascular coagulation 54.03 14.90 48 8848 22123 29921459
Flushing 53.09 14.90 54 8842 29438 29914144
Febrile neutropenia 51.58 14.90 104 8792 106589 29836993
Platelet count decreased 41.56 14.90 95 8801 106034 29837548
Toxicity to various agents 33.72 14.90 6 8890 177177 29766405
Urticaria 32.23 14.90 58 8838 54548 29889034
Chills 31.95 14.90 68 8828 72270 29871312
Anaphylactic shock 29.60 14.90 28 8868 13965 29929617
Neutrophil count decreased 28.85 14.90 48 8848 42406 29901176
Septic shock 28.33 14.90 60 8836 63547 29880035
Chest discomfort 27.72 14.90 49 8847 45431 29898151
Acute graft versus host disease in skin 27.53 14.90 17 8879 4499 29939083
Anaphylactic reaction 26.61 14.90 37 8859 27945 29915637
Blood pressure decreased 26.50 14.90 49 8847 47026 29896556
Product use issue 26.03 14.90 48 8848 45968 29897614
Cytomegalovirus infection 25.09 14.90 33 8863 23641 29919941
Therapeutic product effect prolonged 23.97 14.90 7 8889 279 29943303
Oxygen saturation decreased 22.94 14.90 44 8852 43396 29900186
Antithrombin III decreased 21.76 14.90 7 8889 387 29943195
White blood cell count decreased 21.35 14.90 64 8832 83883 29859699
Posthaemorrhagic hydrocephalus 20.76 14.90 5 8891 93 29943489
Pallor 20.26 14.90 28 8868 21021 29922561
Epstein-Barr virus associated lymphoproliferative disorder 20.22 14.90 10 8886 1718 29941864
Drug interaction 19.92 14.90 18 8878 199550 29744032
Cytomegalovirus viraemia 19.36 14.90 15 8881 5714 29937868
Off label use 19.14 14.90 133 8763 249157 29694425
Chronic graft versus host disease 18.96 14.90 13 8883 4106 29939476
Pneumonia 18.34 14.90 165 8731 334141 29609441
Hepatic function abnormal 18.01 14.90 39 8857 41906 29901676
Sepsis 16.93 14.90 87 8809 146308 29797274
Traumatic shock 16.35 14.90 3 8893 13 29943569
Human herpesvirus 6 infection 16.24 14.90 9 8887 1949 29941633
Insulin-like growth factor decreased 15.78 14.90 5 8891 263 29943319
Phaeochromocytoma crisis 15.26 14.90 3 8893 20 29943562
Erythema 15.14 14.90 54 8842 77397 29866185

Pharmacologic Action:

SourceCodeDescription
MeSH PA D000893 Anti-Inflammatory Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Disorder of musculoskeletal system indication 928000 DOID:17
Cerebral edema indication 2032001
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
Severe adrenal insufficiency indication 24867002
Sarcoidosis indication 31541009 DOID:11335
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Tendinitis indication 34840004 DOID:971
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
Tenosynovitis indication 67801009 DOID:970
Rheumatoid arthritis indication 69896004 DOID:7148
Transfusion reaction due to serum protein reaction indication 72284000
Acquired thrombocytopenia indication 74576004 DOID:11126
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Autoimmune disease indication 85828009
Infection by larvae of Trichinella spiralis indication 88264003
Congenital hypoplastic anemia indication 88854002 DOID:1339
Acute lymphoid leukemia indication 91857003 DOID:9952
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009
Non-Hodgkin's lymphoma indication 118601006
Mycosis fungoides indication 118618005
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Transplanted organ rejection indication 213148006
Adrenogenital disorder indication 267395000 DOID:0050811
Eruption of skin indication 271807003 DOID:0050486
Disorder of eye indication 371405004 DOID:5614
Primary adrenocortical insufficiency indication 373662000
Adrenal cortical hypofunction indication 386584007 DOID:10493
Erythroderma indication 399992009
Autoimmune hemolytic anemia indication 413603009 DOID:718
Synovitis indication 416209007 DOID:2703
Post traumatic osteoarthritis indication 699262001
Erythroblastic Anemia indication
Diagnostic Test for Cushing's Syndrome indication
Transfusion Reaction Urticaria indication
Systemic Dermatomyositis indication
Synovitis due to Osteoarthritis indication
Respiratory distress syndrome in the newborn off-label use 46775006
Neonatal Bronchopulmonary Dysplasia off-label use
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Inactive tuberculosis contraindication 11999007
Peptic ulcer contraindication 13200003 DOID:750
Measles contraindication 14189004 DOID:8622
Esophagitis contraindication 16761005 DOID:11963
Mood swings contraindication 18963009
Cirrhosis of liver contraindication 19943007 DOID:5082
Glaucoma contraindication 23986001 DOID:1686
Abscess of intestine contraindication 24557004
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Duodenal ulcer disease contraindication 51868009 DOID:1724
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
Kidney disease contraindication 90708001 DOID:557
Bilateral cataracts contraindication 95722004
Eye infection contraindication 128351009
Disorder of muscle contraindication 129565002 DOID:423
Anastomosis of intestine contraindication 235407009
Diverticulitis of gastrointestinal tract contraindication 271366000
Varicella-zoster virus infection contraindication 309465005
Viral eye infection contraindication 312132001
Gastric ulcer contraindication 397825006 DOID:10808
Exposure to varicella contraindication 444453009

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.23 acidic
pKa2 12.94 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Glucocorticoid receptor Transcription factor Kd 6.72 CHEMBL

External reference:

IDSource
D00978 KEGG_DRUG
4017945 VUID
N0000146295 NUI
83784-20-7 SECONDARY_CAS_RN
4017945 VANDF
C0056387 UMLSCUI
CHEBI:5782 CHEBI
CHEMBL977 ChEMBL_ID
CHEMBL3989663 ChEMBL_ID
CHEMBL1200495 ChEMBL_ID
DB14545 DRUGBANK_ID
C007133 MESH_SUPPLEMENTAL_RECORD_UI
LIU00Z1Z84 UNII
16623 PUBCHEM_CID
21651 RXNORM
20708 MMSL
41706 MMSL
4843 MMSL
73114 MMSL
002152 NDDF
005251 NDDF
109066000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 0009-0005 INJECTION, POWDER, FOR SOLUTION 1000 mg INTRAMUSCULAR NDA 22 sections
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 0009-0011 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAMUSCULAR NDA 22 sections
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 0009-0013 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAMUSCULAR NDA 22 sections
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 0009-0016 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAMUSCULAR NDA 22 sections
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 0009-0825 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAMUSCULAR NDA 22 sections
SOLU-CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 51662-1261 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAMUSCULAR NDA 13 sections
SOLU-CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 51662-1262 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAMUSCULAR NDA 13 sections
Solu-Cortef HUMAN PRESCRIPTION DRUG LABEL 1 55154-3942 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAMUSCULAR NDA 22 sections