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

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 1388 50-23-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocortisone
  • 17-hydroxycorticosterone
  • acticort
  • cetacort
  • hydracort
  • hydrasson
  • hydrocortisyl
  • cortisol
The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.
  • Molecular weight: 362.47
  • Formula: C21H30O5
  • CLOGP: 1.89
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 94.83
  • ALOGS: -3.26
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.42 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 353.81 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
May 27, 2021 EMA Diurnal Europe B.V.
Aug. 5, 1952 FDA MERCK

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 415.67 9.42 1131 141634 154826 53051475
Completed suicide 327.85 9.42 9 142756 138192 53068109
Adrenocortical insufficiency acute 311.27 9.42 126 142639 1387 53204914
Anti-cyclic citrullinated peptide antibody positive 288.25 9.42 535 142230 56637 53149664
Pericarditis 270.42 9.42 558 142207 63848 53142453
Adrenal insufficiency 266.71 9.42 259 142506 14570 53191731
Rheumatoid factor positive 240.38 9.42 411 142354 40787 53165514
Drug hypersensitivity 238.26 9.42 1364 141401 263878 52942423
Wound 229.77 9.42 650 142115 90907 53115394
Discomfort 216.76 9.42 654 142111 94818 53111483
Hand deformity 206.69 9.42 596 142169 84253 53122048
Toxicity to various agents 192.91 9.42 182 142583 219416 52986885
Steroid withdrawal syndrome 176.58 9.42 64 142701 507 53205794
Synovitis 172.39 9.42 657 142108 107236 53099065
Glossodynia 171.32 9.42 624 142141 99667 53106634
Death 168.57 9.42 449 142316 356783 52849518
Duodenal ulcer perforation 152.54 9.42 309 142456 34874 53171427
Pemphigus 145.71 9.42 608 142157 103423 53102878
Intentional product use issue 139.28 9.42 469 142296 72025 53134276
Helicobacter infection 137.12 9.42 315 142450 38754 53167547
Hypersensitivity 132.99 9.42 992 141773 209673 52996628
Drug abuse 131.26 9.42 12 142753 65514 53140787
Systemic lupus erythematosus 129.88 9.42 671 142094 124743 53081558
Arthropathy 127.73 9.42 729 142036 140724 53065577
Hepatic enzyme increased 124.38 9.42 666 142099 125529 53080772
Product use issue 116.73 9.42 705 142060 138879 53067422
Colitis ulcerative 116.14 9.42 205 142560 20856 53185445
Intentional overdose 101.73 9.42 27 142738 67178 53139123
Swelling 99.88 9.42 862 141903 190243 53016058
Febrile bone marrow aplasia 99.32 9.42 109 142656 7080 53199221
Overdose 98.42 9.42 86 142679 107650 53098651
Craniopharyngioma 97.73 9.42 30 142735 131 53206170
Fall 87.93 9.42 580 142185 357860 52848441
Blood pressure fluctuation 86.14 9.42 249 142516 35221 53171080
Drug interaction 80.61 9.42 308 142457 219021 52987280
Hypofibrinogenaemia 80.57 9.42 46 142719 1129 53205172
Abdominal discomfort 79.10 9.42 922 141843 220140 52986161
Drug intolerance 78.00 9.42 867 141898 204626 53001675
Secondary adrenocortical insufficiency 77.38 9.42 46 142719 1220 53205081
Condition aggravated 77.15 9.42 1169 141596 295965 52910336
Alopecia 75.51 9.42 959 141806 233624 52972677
Rash 73.61 9.42 1635 141130 444556 52761745
Pituitary tumour benign 71.18 9.42 51 142714 1870 53204431
Maternal exposure during pregnancy 59.16 9.42 657 142108 154982 53051319
Blister 59.06 9.42 387 142378 78366 53127935
Product dose omission issue 58.24 9.42 289 142476 191331 53014970
Rheumatic fever 56.17 9.42 112 142653 12492 53193809
Suicide attempt 53.63 9.42 46 142719 58122 53148179
Device expulsion 53.40 9.42 8 142757 29805 53176496
Cardiac failure congestive 52.96 9.42 105 142660 92652 53113649
Hip arthroplasty 52.36 9.42 179 142586 27683 53178618
Acute kidney injury 50.65 9.42 435 142330 253433 52952868
Urticaria thermal 46.76 9.42 17 142748 136 53206165
Frequent bowel movements 45.99 9.42 112 142653 14300 53192001
Adrenal suppression 45.96 9.42 30 142735 942 53205359
Cerebrovascular accident 45.89 9.42 137 142628 105037 53101264
Female genital tract fistula 45.09 9.42 55 142710 4003 53202298
Cortisol decreased 44.40 9.42 31 142734 1090 53205211
Hyperadrenocorticism 44.19 9.42 21 142744 348 53205953
Swollen joint count increased 44.06 9.42 95 142670 11195 53195106
Joint swelling 43.81 9.42 876 141889 233762 52972539
Hypopituitarism 41.91 9.42 28 142737 915 53205386
Knee arthroplasty 40.70 9.42 188 142577 33381 53172920
Hypothalamic pituitary adrenal axis suppression 38.41 9.42 15 142750 149 53206152
Musculoskeletal injury 37.87 9.42 14 142751 118 53206183
Heart rate irregular 37.47 9.42 130 142635 20254 53186047
Poor venous access 36.73 9.42 82 142683 9893 53196408
Colitis 36.68 9.42 213 142552 41339 53164962
Cardiac failure 36.60 9.42 113 142652 85731 53120570
Anaemia 36.50 9.42 521 142244 276197 52930104
Hypothalamo-pituitary disorder 35.13 9.42 23 142742 726 53205575
Intentional self-injury 34.92 9.42 12 142753 25272 53181029
Sedation 34.71 9.42 18 142747 29657 53176644
Off label use 34.34 9.42 1568 141197 470644 52735657
Drug level below therapeutic 34.24 9.42 46 142719 3687 53202614
Respiratory arrest 34.11 9.42 24 142741 33516 53172785
Serotonin syndrome 34.01 9.42 14 142751 26392 53179909
Neoplasm recurrence 33.54 9.42 37 142728 2417 53203884
Contraindicated product administered 33.33 9.42 529 142236 135100 53071201
Perioral dermatitis 33.11 9.42 12 142753 95 53206206
Irritable bowel syndrome 33.05 9.42 215 142550 43417 53162884
Nausea 32.69 9.42 1673 141092 754418 52451883
Insulin-like growth factor increased 32.32 9.42 23 142742 834 53205467
Eczema 32 9.42 139 142626 24043 53182258
Muscle injury 31.97 9.42 161 142604 29605 53176696
Coma 31.88 9.42 74 142691 61709 53144592
Renal impairment 31.87 9.42 115 142650 83203 53123098
Syncope 31.69 9.42 173 142592 111820 53094481
Cardio-respiratory arrest 31.43 9.42 69 142696 58689 53147612
Inappropriate schedule of product administration 31.17 9.42 322 142443 74556 53131745
Faecal calprotectin increased 30.94 9.42 33 142732 2075 53204226
Tendonitis 30.86 9.42 108 142657 16898 53189403
Breast cancer 30.71 9.42 53 142712 49305 53156996
Human bocavirus infection 30.65 9.42 16 142749 327 53205974
Interstitial lung disease 30.42 9.42 70 142695 58552 53147749
Sleep disorder due to general medical condition, insomnia type 29.99 9.42 137 142628 24212 53182089
Malignant neoplasm progression 29.91 9.42 95 142670 71446 53134855
Myocardial infarction 29.49 9.42 151 142614 99203 53107098
Chronic obstructive pulmonary disease 29.27 9.42 76 142689 60997 53145304
Injury 28.73 9.42 234 142531 50737 53155564
Type 2 diabetes mellitus 28.38 9.42 163 142602 31507 53174794
Asphyxia 28.19 9.42 54 142711 5847 53200454
Hypophysitis 28.18 9.42 28 142737 1619 53204682
Electrocardiogram QT prolonged 27.95 9.42 69 142696 56334 53149967
Cognitive disorder 27.93 9.42 48 142717 44730 53161571
Blood creatinine increased 27.85 9.42 120 142645 82542 53123759
Salpingo-oophorectomy unilateral 27.75 9.42 19 142746 647 53205654
Folliculitis 27.63 9.42 162 142603 31547 53174754
Insulin-like growth factor decreased 27.30 9.42 16 142749 413 53205888
Drug withdrawal syndrome 27.27 9.42 21 142744 28001 53178300
Therapeutic response shortened 27.20 9.42 59 142706 6980 53199321
Wrong technique in product usage process 27.05 9.42 77 142688 59955 53146346
Haemoglobin decreased 27.02 9.42 236 142529 137071 53069230
Plasma cell myeloma 26.63 9.42 55 142710 47819 53158482
Hospitalisation 26.51 9.42 99 142666 70913 53135388
Body temperature fluctuation 26.33 9.42 30 142735 2031 53204270
Gastrointestinal haemorrhage 26.22 9.42 118 142647 80212 53126089
Atrial fibrillation 26.12 9.42 183 142582 111469 53094832
Lactic acidosis 26.03 9.42 37 142728 37216 53169085
Arthralgia 25.88 9.42 1431 141334 438352 52767949
Drug tolerance decreased 25.44 9.42 59 142706 7299 53199002
Urticaria 24.88 9.42 506 142259 135379 53070922
Natural killer-cell leukaemia 24.47 9.42 10 142755 113 53206188
Tendon pain 24.37 9.42 36 142729 3152 53203149
Adrenal disorder 24.19 9.42 24 142741 1385 53204916
Suicidal ideation 24.16 9.42 82 142683 60429 53145872
Antithrombin III 23.84 9.42 11 142754 170 53206131
Haematochezia 23.62 9.42 194 142571 42164 53164137
Injection site reaction 23.51 9.42 65 142700 51101 53155200
Disease progression 23.38 9.42 168 142597 101752 53104549
Allergy test positive 23.23 9.42 14 142751 381 53205920
Tendon rupture 23.13 9.42 60 142705 7964 53198337
Mucous stools 22.88 9.42 34 142731 2992 53203309
Anal fistula 22.61 9.42 33 142732 2858 53203443
Platelet count decreased 22.52 9.42 183 142582 107916 53098385
Intentional product misuse 22.51 9.42 63 142702 49329 53156972
Faecal volume decreased 22.43 9.42 11 142754 196 53206105
Septic shock 22.39 9.42 260 142505 61969 53144332
Metastases to bone 22.20 9.42 12 142753 19316 53186985
Blood creatine phosphokinase increased 22.08 9.42 27 142738 28958 53177343
Skin weeping 21.86 9.42 13 142752 345 53205956
Normal tension glaucoma 21.58 9.42 8 142757 68 53206233
Blood count abnormal 21.38 9.42 14 142751 20301 53186000
Anal abscess 21.35 9.42 38 142727 3890 53202411
Injection site swelling 21.24 9.42 52 142713 42576 53163725
Airway peak pressure increased 21.22 9.42 12 142753 289 53206012
Proctalgia 21.17 9.42 45 142720 5251 53201050
Bradycardia 21.08 9.42 108 142657 70948 53135353
Product quality issue 21.04 9.42 42 142723 36981 53169320
Pulmonary arterial hypertension 20.94 9.42 25 142740 27097 53179204
Depressed level of consciousness 20.89 9.42 75 142690 54353 53151948
Erythrodermic psoriasis 20.76 9.42 19 142746 991 53205310
Somnolence 20.64 9.42 320 142445 167414 53038887
Diaphragm muscle weakness 20.59 9.42 6 142759 21 53206280
Gastroenteritis norovirus 20.50 9.42 24 142741 1673 53204628
Eczema herpeticum 20.36 9.42 9 142756 125 53206176
Hepatic function abnormal 20.01 9.42 43 142722 36856 53169445
Clostridium difficile colitis 19.90 9.42 105 142660 19660 53186641
Injection site erythema 19.89 9.42 123 142642 77126 53129175
Neuroleptic malignant syndrome 19.86 9.42 4 142761 12029 53194272
Anal fissure 19.84 9.42 32 142733 3024 53203277
Meningitis candida 19.70 9.42 7 142758 52 53206249
Oedema peripheral 19.62 9.42 330 142435 170457 53035844
Fistula 19.38 9.42 60 142705 8810 53197491
Labelled drug-drug interaction medication error 19.35 9.42 3 142762 10896 53195405
Secondary immunodeficiency 19.16 9.42 19 142746 1096 53205205
Perfume sensitivity 18.88 9.42 15 142750 644 53205657
Drug level decreased 18.86 9.42 50 142715 6724 53199577
Loss of consciousness 18.80 9.42 205 142560 114007 53092294
Treatment failure 18.74 9.42 463 142302 127940 53078361
Acute myocardial infarction 18.63 9.42 38 142727 33197 53173104
Blood cholesterol increased 18.45 9.42 220 142545 52769 53153532
Arteriosclerosis coronary artery 18.30 9.42 57 142708 8397 53197904
Accidental exposure to product 18.09 9.42 22 142743 23652 53182649
Pituitary tumour recurrent 17.71 9.42 7 142758 72 53206229
Therapy cessation 17.52 9.42 30 142735 27995 53178306
Febrile neutropenia 17.34 9.42 385 142380 104551 53101750
Wheezing 17.33 9.42 258 142507 65017 53141284
Enterococcal sepsis 17.32 9.42 20 142745 1374 53204927
Abdominal pain 17.30 9.42 844 141921 255059 52951242
Cerebral microangiopathy 17.28 9.42 10 142755 252 53206049
Sinusitis fungal 17.27 9.42 20 142745 1378 53204923
Rhabdomyolysis 17.21 9.42 60 142705 43863 53162438
B-lymphocyte count increased 17.20 9.42 8 142757 126 53206175
Natural killer cell count decreased 17.07 9.42 6 142759 43 53206258
Leukoencephalopathy 17.01 9.42 36 142729 4188 53202113
Vaginal flatulence 16.96 9.42 10 142755 261 53206040
White blood cell count decreased 16.86 9.42 233 142532 124242 53082059
Excessive eye blinking 16.72 9.42 16 142749 883 53205418
Diabetes insipidus 16.64 9.42 27 142738 2564 53203737
Skin fragility 16.64 9.42 14 142751 652 53205649
Melaena 16.59 9.42 33 142732 29096 53177205
Vaginal discharge 16.57 9.42 43 142722 5710 53200591
Tuberculosis gastrointestinal 16.50 9.42 11 142754 358 53205943
Neutropenic infection 16.40 9.42 18 142747 1169 53205132
Dry skin 16.38 9.42 191 142574 45569 53160732
Mastocytosis 16.35 9.42 12 142753 457 53205844
Lupus vulgaris 16.30 9.42 13 142752 561 53205740
Cardiac arrest 16.27 9.42 166 142599 93501 53112800
Neutropenia 16.26 9.42 314 142451 158871 53047430
Balance disorder 16.14 9.42 122 142643 73085 53133216
Abortion spontaneous 16.14 9.42 67 142698 46568 53159733
Diarrhoea haemorrhagic 16.11 9.42 54 142711 8266 53198035
Tendon disorder 16.10 9.42 42 142723 5593 53200708
Drug level above therapeutic 16.09 9.42 34 142731 3950 53202351
Drug specific antibody present 15.99 9.42 31 142734 3387 53202914
Live birth 15.85 9.42 81 142684 14978 53191323
Weight increased 15.84 9.42 684 142081 203883 53002418
Schizophrenia 15.80 9.42 4 142761 10275 53196026
Tremor 15.76 9.42 239 142526 125497 53080804
Hypogonadism 15.73 9.42 7 142758 99 53206202
Femur fracture 15.56 9.42 54 142711 39531 53166770
Cardiac disorder 15.32 9.42 69 142696 46897 53159404
Sputum increased 15.24 9.42 24 142741 2222 53204079
Macular degeneration 15.21 9.42 7 142758 12354 53193947
Injection site pain 15.09 9.42 213 142552 113178 53093123
Pneumonia 15.09 9.42 914 141851 406255 52800046
Red blood cell sedimentation rate abnormal 14.96 9.42 12 142753 15677 53190624
Glomerulonephritis chronic 14.80 9.42 8 142757 176 53206125
CSF lymphocyte count abnormal 14.78 9.42 3 142762 0 53206301
Thyroid stimulating immunoglobulin increased 14.73 9.42 7 142758 116 53206185
Complication associated with device 14.63 9.42 13 142752 16152 53190149
Rhinovirus infection 14.49 9.42 32 142733 3833 53202468
Pyoderma gangrenosum 14.36 9.42 28 142737 3071 53203230
Accidental overdose 14.36 9.42 22 142743 21457 53184844
Orthostatic hypotension 14.27 9.42 37 142728 29716 53176585
Unevaluable event 14.25 9.42 76 142689 49422 53156879
Dyskinesia 14.21 9.42 41 142724 31792 53174509
Pseudostroke 14.19 9.42 4 142761 12 53206289
Deep vein thrombosis postoperative 14.12 9.42 16 142749 1077 53205224
Product prescribing error 14.08 9.42 25 142740 23006 53183295
Fibromyalgia 14.05 9.42 180 142585 43895 53162406
Medication error 14.03 9.42 50 142715 36315 53169986
Rectal abscess 13.98 9.42 16 142749 1088 53205213
Nasal polyps 13.93 9.42 27 142738 2949 53203352
Hepatotoxicity 13.89 9.42 34 142731 27846 53178455
Ascites 13.80 9.42 57 142708 39678 53166623
Excessive skin 13.78 9.42 7 142758 135 53206166
Cerebral vasoconstriction 13.76 9.42 16 142749 1107 53205194
Osteonecrosis of jaw 13.74 9.42 50 142715 36096 53170205
PO2 decreased 13.71 9.42 19 142746 1568 53204733
Candida infection 13.69 9.42 115 142650 25158 53181143
Increased bronchial secretion 13.61 9.42 20 142745 1743 53204558
Dysarthria 13.59 9.42 59 142706 40509 53165792
Vertigo 13.56 9.42 91 142674 55990 53150311
Hyperemesis gravidarum 13.54 9.42 12 142753 600 53205701
Neutropenic sepsis 13.52 9.42 76 142689 14573 53191728
Hepatic cirrhosis 13.51 9.42 17 142748 18005 53188296
Hepatitis 13.48 9.42 46 142719 33848 53172453
Therapeutic product effect incomplete 13.45 9.42 169 142596 91615 53114686
Pituitary haemorrhage 13.28 9.42 6 142759 88 53206213
Aborted pregnancy 13.24 9.42 5 142760 45 53206256
Dry eye 13.15 9.42 46 142719 33598 53172703
Breast cancer metastatic 13.08 9.42 13 142752 15315 53190986
Aspergillus infection 13.08 9.42 47 142718 7449 53198852
X-ray abnormal 13.00 9.42 23 142742 2343 53203958
Therapeutic reaction time decreased 12.97 9.42 17 142748 1330 53204971
Shared psychotic disorder 12.93 9.42 4 142761 18 53206283
Hypercapnia 12.89 9.42 36 142729 4991 53201310
Erythema 12.85 9.42 528 142237 156441 53049860
Agitation 12.78 9.42 98 142667 58528 53147773
Hypertensive crisis 12.73 9.42 12 142753 14494 53191807
Palmar-plantar erythrodysaesthesia syndrome 12.72 9.42 24 142741 21582 53184719
Ear canal erythema 12.71 9.42 3 142762 3 53206298
Astrocytoma 12.70 9.42 6 142759 98 53206203
Secondary hypogonadism 12.65 9.42 6 142759 99 53206202
Skin atrophy 12.64 9.42 34 142731 4612 53201689
Blood growth hormone increased 12.61 9.42 10 142755 428 53205873
Embolism venous 12.59 9.42 26 142739 2973 53203328
Suffocation feeling 12.58 9.42 17 142748 1370 53204931
Transient ischaemic attack 12.56 9.42 51 142714 35674 53170627
Device difficult to use 12.54 9.42 6 142759 10353 53195948
PCO2 increased 12.46 9.42 16 142749 1227 53205074
Herpes simplex hepatitis 12.44 9.42 9 142756 335 53205966
Coronary artery dissection 12.40 9.42 13 142752 801 53205500
Pneumatosis 12.37 9.42 10 142755 440 53205861
Autoimmune nephritis 12.37 9.42 9 142756 338 53205963
Glucocorticoid deficiency 12.35 9.42 8 142757 248 53206053
Pseudomonas infection 12.34 9.42 58 142707 10370 53195931
Renal failure 12.29 9.42 233 142532 118219 53088082
Status asthmaticus 12.28 9.42 14 142751 948 53205353
Lung hyperinflation 12.25 9.42 16 142749 1248 53205053
Coronary artery disease 12.22 9.42 47 142718 33390 53172911
Blood corticotrophin decreased 11.96 9.42 8 142757 262 53206039
Geotrichum infection 11.95 9.42 10 142755 462 53205839
Prescription drug used without a prescription 11.94 9.42 19 142746 1775 53204526
Nasopharyngitis 11.91 9.42 629 142136 191666 53014635
Skin injury 11.89 9.42 18 142747 1610 53204691
Dizziness 11.85 9.42 847 141918 371412 52834889
International normalised ratio increased 11.80 9.42 77 142688 47684 53158617
Cerebrospinal fluid leakage 11.78 9.42 14 142751 992 53205309
Eosinophilic oesophagitis 11.57 9.42 8 142757 277 53206024
Vulvovaginal pain 11.52 9.42 22 142743 2377 53203924
Crohn's disease 11.50 9.42 42 142723 6708 53199593
No adverse event 11.46 9.42 60 142705 39205 53167096
Anorectal ulcer 11.41 9.42 5 142760 68 53206233
Heart rate decreased 11.40 9.42 150 142615 36797 53169504
Toxic skin eruption 11.38 9.42 11 142754 13128 53193173
Fluid retention 11.37 9.42 92 142673 54309 53151992
Product storage error 11.36 9.42 11 142754 13119 53193182
Foetal exposure during pregnancy 11.32 9.42 51 142714 34664 53171637
Therapeutic product effect decreased 11.30 9.42 427 142338 125228 53081073
Pneumatosis intestinalis 11.28 9.42 21 142744 2225 53204076
Staphylococcal infection 11.28 9.42 155 142610 38393 53167908
Parkinsonism 11.25 9.42 5 142760 9008 53197293
Non-consummation 11.21 9.42 5 142760 71 53206230
Sensitivity to weather change 11.21 9.42 39 142726 6083 53200218
Extrapyramidal disorder 11.19 9.42 10 142755 12392 53193909
Abnormal faeces 11.17 9.42 32 142733 4502 53201799
Dystonia 11.16 9.42 11 142754 13010 53193291
Thyrotoxic crisis 11 9.42 12 142753 774 53205527
Blood triglycerides decreased 10.97 9.42 5 142760 75 53206226
Ankle fracture 10.96 9.42 17 142748 16498 53189803
Lower respiratory tract infection 10.96 9.42 320 142445 90661 53115640
Intestinal stenosis 10.85 9.42 23 142742 2678 53203623
Bronchopulmonary aspergillosis 10.85 9.42 49 142716 8616 53197685
Myelosuppression 10.81 9.42 11 142754 12817 53193484
Pituitary infarction 10.79 9.42 4 142761 34 53206267
Enteritis 10.78 9.42 44 142721 7402 53198899
Feeding intolerance 10.77 9.42 10 142755 531 53205770
Aspartate aminotransferase increased 10.77 9.42 159 142606 83870 53122431
Respiratory depression 10.77 9.42 11 142754 12795 53193506
Seizure 10.75 9.42 264 142501 129245 53077056
Decreased appetite 10.73 9.42 468 142297 214506 52991795
Drug eruption 10.71 9.42 33 142732 25061 53181240
Muscle rigidity 10.71 9.42 8 142757 10833 53195468
Brachycephaly 10.69 9.42 4 142761 35 53206266
Myoclonus 10.68 9.42 16 142749 15748 53190553
Bacterial infection 10.68 9.42 82 142683 17465 53188836
Oesophageal adenocarcinoma recurrent 10.59 9.42 4 142761 36 53206265
Gastrointestinal scarring 10.58 9.42 7 142758 225 53206076
Pain 10.52 9.42 1759 141006 586639 52619662
Wound secretion 10.50 9.42 30 142735 4213 53202088
Ileectomy 10.48 9.42 6 142759 148 53206153
Kidney infection 10.45 9.42 87 142678 18980 53187321
Reaction to preservatives 10.44 9.42 7 142758 230 53206071
Encephalitis autoimmune 10.44 9.42 15 142750 1281 53205020
Adjustment disorder with depressed mood 10.40 9.42 22 142743 2558 53203743
Thrombocytopenia 10.40 9.42 287 142478 138440 53067861
Visual pathway disorder 10.40 9.42 4 142761 38 53206263
Tuberous sclerosis complex 10.35 9.42 5 142760 86 53206215
Uterine cyst 10.34 9.42 9 142756 439 53205862
Akathisia 10.32 9.42 5 142760 8566 53197735
Depression 10.31 9.42 393 142372 182659 53023642
Arrhythmia 10.29 9.42 57 142708 36722 53169579
Osteopenia 10.28 9.42 21 142744 18334 53187967
Respiratory acidosis 10.26 9.42 39 142726 6349 53199952
Proctitis 10.26 9.42 19 142746 2006 53204295
Faecal calprotectin abnormal 10.22 9.42 4 142761 40 53206261
Anti-thyroid antibody positive 10.12 9.42 9 142756 452 53205849
Thyroxine free increased 10.07 9.42 12 142753 852 53205449
Pruritus 10.06 9.42 915 141850 292917 52913384
Colonic abscess 10.01 9.42 12 142753 858 53205443
Blood gonadotrophin decreased 9.98 9.42 3 142762 12 53206289
Mobility decreased 9.95 9.42 271 142494 76000 53130301
Blood smear test abnormal 9.86 9.42 5 142760 96 53206205
Pulmonary hypertension 9.77 9.42 59 142706 37211 53169090
Maternal exposure timing unspecified 9.76 9.42 24 142741 3082 53203219
Skin wrinkling 9.74 9.42 13 142752 1035 53205266
Dislocation of vertebra 9.69 9.42 22 142743 2684 53203617
Pneumonia aspiration 9.69 9.42 53 142712 34248 53172053
Vaccination site inflammation 9.65 9.42 4 142761 47 53206254
Aplastic anaemia 9.64 9.42 46 142719 8275 53198026
Pleural effusion 9.57 9.42 173 142592 88406 53117895
Oropharyngeal pain 9.56 9.42 285 142480 80983 53125318
Hallucination 9.52 9.42 95 142670 53743 53152558
Pneumopericardium 9.50 9.42 4 142761 49 53206252
Therapy interrupted 9.45 9.42 24 142741 19412 53186889
Drug resistance 9.44 9.42 25 142740 19937 53186364
Blood corticotrophin increased 9.43 9.42 4 142761 50 53206251
Neutrophilic panniculitis 9.43 9.42 4 142761 50 53206251

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
Adrenal insufficiency 236.27 9.74 208 76304 11760 32425254
Infusion related reaction 170.30 9.74 349 76163 45250 32391764
Blood pressure fluctuation 169.99 9.74 223 76289 19912 32417102
Craniopharyngioma 169.19 9.74 51 76461 242 32436772
Completed suicide 160.21 9.74 16 76496 92501 32344513
Toxicity to various agents 155.90 9.74 115 76397 177926 32259088
Death 153.94 9.74 430 76082 382087 32054927
Drug abuse 149.66 9.74 10 76502 80233 32356781
Adrenocortical insufficiency acute 147.07 9.74 70 76442 1334 32435680
Graft loss 138.94 9.74 59 76453 849 32436165
Colitis ulcerative 121.51 9.74 174 76338 16877 32420137
Serum sickness 118.77 9.74 67 76445 1836 32435178
Febrile bone marrow aplasia 114.27 9.74 119 76393 8296 32428718
Off label use 111.12 9.74 1154 75358 305166 32131848
Hypofibrinogenaemia 95.31 9.74 56 76456 1660 32435354
Frequent bowel movements 94.59 9.74 114 76398 9338 32427676
Intentional product use issue 91.61 9.74 262 76250 41949 32395065
Febrile neutropenia 84.85 9.74 526 75986 119040 32317974
Product use issue 82.01 9.74 292 76220 52485 32384529
Hypopituitarism 76.00 9.74 50 76462 1817 32435197
Diabetes insipidus 75.72 9.74 57 76455 2575 32434439
Leukoencephalopathy 74.10 9.74 68 76444 4057 32432957
Drug interaction 69.65 9.74 271 76241 217914 32219100
Heart rate irregular 68.92 9.74 121 76391 13957 32423057
Intentional overdose 65.13 9.74 10 76502 41591 32395423
Inappropriate schedule of product administration 58.36 9.74 238 76274 45587 32391427
Drug specific antibody present 54.93 9.74 46 76466 2427 32434587
Adrenal suppression 54.17 9.74 29 76483 715 32436299
Condition aggravated 54.08 9.74 582 75930 155079 32281935
Pituitary tumour benign 53.64 9.74 30 76482 808 32436206
Interstitial lung disease 51.77 9.74 46 76466 64955 32372059
Insulin-like growth factor decreased 50.36 9.74 20 76492 240 32436774
Steroid withdrawal syndrome 49.31 9.74 19 76493 209 32436805
Impaired quality of life 48.54 9.74 42 76470 2318 32434696
Tendon pain 48.22 9.74 45 76467 2743 32434271
Septic shock 47.30 9.74 301 76211 68688 32368326
Mucosal inflammation 46.89 9.74 179 76333 33255 32403759
Arthralgia 46.09 9.74 543 75969 147905 32289109
Pseudostroke 44.10 9.74 12 76500 36 32436978
Tendon disorder 42.61 9.74 41 76471 2597 32434417
Body temperature fluctuation 42.19 9.74 32 76480 1462 32435552
Overdose 41.78 9.74 89 76423 86988 32350026
Hypertriglyceridaemia 40.19 9.74 73 76439 8646 32428368
Tendon rupture 40.01 9.74 66 76446 7237 32429777
Suicide attempt 39.95 9.74 20 76492 38224 32398790
Heart rate decreased 39.61 9.74 140 76372 25060 32411954
Myocardial infarction 38.82 9.74 158 76354 125518 32311496
Renal impairment 37.78 9.74 102 76410 91870 32345144
Fistula 37.69 9.74 55 76457 5424 32431590
Neoplasm recurrence 37.27 9.74 34 76478 2013 32435001
Faecal calprotectin increased 37.16 9.74 29 76483 1383 32435631
Aplastic anaemia 36.90 9.74 64 76448 7309 32429705
Colitis 36.07 9.74 167 76345 33784 32403230
Acute kidney injury 35.55 9.74 482 76030 292986 32144028
Cortisol decreased 35.20 9.74 24 76488 926 32436088
Hypophysitis 35.16 9.74 33 76479 2026 32434988
Insulin-like growth factor increased 34.78 9.74 25 76487 1051 32435963
Fall 33.85 9.74 297 76215 195904 32241110
Crohn's disease 33.41 9.74 46 76466 4299 32432715
Chorioretinopathy 33.08 9.74 28 76484 1499 32435515
Glioma 31.91 9.74 16 76496 343 32436671
Hypertrophic cardiomyopathy 31.83 9.74 23 76489 975 32436039
Pneumoretroperitoneum 31.81 9.74 10 76502 56 32436958
Pelvic abscess 31.75 9.74 23 76489 979 32436035
Bronchiectasis 31.54 9.74 58 76454 6934 32430080
Lichen planus 31.33 9.74 22 76490 891 32436123
Epiphysiolysis 30.90 9.74 11 76501 95 32436919
Drug hypersensitivity 30.53 9.74 285 76227 73115 32363899
Cardiac failure 30.38 9.74 112 76400 91561 32345453
Meningitis candida 29.79 9.74 10 76502 71 32436943
Drug level below therapeutic 28.69 9.74 42 76470 4153 32432861
Anaemia 28.61 9.74 363 76149 223261 32213753
Flushing 27.99 9.74 146 76366 30981 32406033
Myelopathy 27.69 9.74 29 76483 2034 32434980
Therapeutic response shortened 27.68 9.74 44 76468 4676 32432338
Pituitary haemorrhage 27.51 9.74 12 76500 185 32436829
Perioral dermatitis 26.28 9.74 10 76502 106 32436908
Growth retardation 26.17 9.74 26 76486 1713 32435301
Sedation 25.71 9.74 6 76506 18520 32418494
Stevens-Johnson syndrome 25.27 9.74 99 76413 18610 32418404
Candida infection 24.41 9.74 91 76421 16712 32420302
Adrenocorticotropic hormone deficiency 24.33 9.74 16 76496 581 32436433
Thermophobia 24.30 9.74 9 76503 88 32436926
Idiopathic intracranial hypertension 23.57 9.74 16 76496 613 32436401
Shared psychotic disorder 23.44 9.74 6 76506 13 32437001
Atrial fibrillation 23.17 9.74 170 76342 116534 32320480
Cardio-respiratory arrest 23.05 9.74 62 76450 55927 32381087
Blood pressure increased 22.72 9.74 286 76226 79068 32357946
Symptom masked 22.34 9.74 15 76497 564 32436450
Blood creatine phosphokinase increased 22.20 9.74 46 76466 45430 32391584
Hallucination 21.87 9.74 58 76454 52561 32384453
Klebsiella infection 21.68 9.74 54 76458 7958 32429056
Gastrointestinal haemorrhage 21.64 9.74 118 76394 86764 32350250
Thyroxine free decreased 21.56 9.74 11 76501 245 32436769
Periorbital infection 21.54 9.74 9 76503 124 32436890
Posterior reversible encephalopathy syndrome 21.30 9.74 60 76452 9516 32427498
Cardiac failure congestive 21.27 9.74 115 76397 84737 32352277
Glioblastoma multiforme 21.07 9.74 17 76495 851 32436163
Musculoskeletal injury 20.98 9.74 9 76503 133 32436881
Optic nerve disorder 20.71 9.74 15 76497 638 32436376
Neurotoxicity 20.56 9.74 80 76432 14990 32422024
Onychoclasis 20.49 9.74 23 76489 1745 32435269
Cholangitis infective 20.41 9.74 11 76501 275 32436739
Erythema 20.28 9.74 291 76221 82814 32354200
Astrocytoma 20.17 9.74 10 76502 209 32436805
Neuroleptic malignant syndrome 20.07 9.74 8 76504 17487 32419527
Subdural haematoma 20.00 9.74 11 76501 19942 32417072
Blood growth hormone decreased 19.98 9.74 6 76506 28 32436986
Rash erythematous 19.96 9.74 110 76402 23829 32413185
Dermatitis diaper 19.71 9.74 11 76501 295 32436719
Bronchial haemorrhage 19.35 9.74 15 76497 708 32436306
Blood growth hormone increased 19.23 9.74 10 76502 232 32436782
Hypogonadism 19.22 9.74 22 76490 1705 32435309
Pituitary tumour recurrent 19.12 9.74 7 76505 66 32436948
Drug level decreased 19.11 9.74 45 76467 6401 32430613
Vestibular neuronitis 18.88 9.74 9 76503 172 32436842
Renal failure 18.81 9.74 214 76298 134264 32302750
Secondary adrenocortical insufficiency 18.55 9.74 18 76494 1152 32435862
Anaphylactic reaction 18.46 9.74 128 76384 30044 32406970
Extrapyramidal disorder 18.30 9.74 3 76509 11892 32425122
Anal fistula 17.93 9.74 35 76477 4376 32432638
Diarrhoea haemorrhagic 17.91 9.74 43 76469 6192 32430822
Pouchitis 17.84 9.74 14 76498 673 32436341
Gastrointestinal inflammation 17.74 9.74 29 76483 3155 32433859
Meningitis tuberculous 17.66 9.74 14 76498 683 32436331
Gastrointestinal anastomotic leak 17.61 9.74 11 76501 365 32436649
Cryptococcal fungaemia 17.55 9.74 7 76505 85 32436929
Syncope 17.53 9.74 132 76380 89992 32347022
Splenic peliosis 17.47 9.74 5 76507 19 32436995
Hyperbilirubinaemia 17.22 9.74 85 76427 17645 32419369
Otitis media acute 17.18 9.74 12 76500 482 32436532
Blood thyroid stimulating hormone decreased 17.16 9.74 22 76490 1918 32435096
Intentional product misuse 17.15 9.74 37 76475 36014 32401000
Nervous system disorder 17.11 9.74 72 76440 13977 32423037
Clostridium difficile infection 17.06 9.74 85 76427 17711 32419303
Bone cyst 17.01 9.74 13 76499 601 32436413
Angina pectoris 16.90 9.74 30 76482 31396 32405618
Hospitalisation 16.76 9.74 59 76453 48912 32388102
Aggression 16.68 9.74 43 76469 39346 32397668
Joint ankylosis 16.64 9.74 11 76501 403 32436611
Chills 16.57 9.74 267 76245 77817 32359197
Lacrimal duct neoplasm 16.37 9.74 5 76507 25 32436989
Mantle cell lymphoma stage III 16.37 9.74 5 76507 25 32436989
Posturing 16.34 9.74 12 76500 522 32436492
Lactic acidosis 16.30 9.74 34 76478 33502 32403512
Hyperkalaemia 16.15 9.74 97 76415 69653 32367361
Eczema 16.14 9.74 74 76438 14906 32422108
Product quality issue 16.05 9.74 13 76499 19220 32417794
Pituitary tumour 16.02 9.74 12 76500 538 32436476
Poor venous access 15.85 9.74 27 76485 3039 32433975
Body height below normal 15.81 9.74 9 76503 251 32436763
Cerebrospinal fluid leakage 15.50 9.74 11 76501 453 32436561
Electrocardiogram QT prolonged 15.50 9.74 45 76467 39596 32397418
Body temperature decreased 15.46 9.74 59 76453 10955 32426059
Thyroxine decreased 15.43 9.74 7 76505 119 32436895
Anal inflammation 15.26 9.74 10 76502 361 32436653
Abdominal pain 15.21 9.74 460 76052 149069 32287945
Congenital cardiovascular anomaly 15.17 9.74 8 76504 191 32436823
Intentional self-injury 14.92 9.74 7 76505 13893 32423121
Coma 14.81 9.74 51 76461 42561 32394453
Addison's disease 14.70 9.74 4 76508 12 32437002
Renal disorder 14.50 9.74 23 76489 25160 32411854
Cushingoid 14.42 9.74 24 76488 2650 32434364
Anal abscess 14.42 9.74 37 76475 5553 32431461
Groin infection 14.22 9.74 7 76505 144 32436870
Pulmonary arterial hypertension 13.99 9.74 3 76509 9818 32427196
Perirectal abscess 13.85 9.74 18 76494 1591 32435423
Gingival disorder 13.84 9.74 17 76495 1420 32435594
Lichenification 13.70 9.74 9 76503 326 32436688
Feeling hot 13.68 9.74 77 76435 16809 32420205
Anaplastic astrocytoma 13.55 9.74 7 76505 160 32436854
Perineal pain 13.42 9.74 13 76499 830 32436184
Feeling cold 13.38 9.74 53 76459 10011 32427003
Mean cell volume decreased 13.33 9.74 16 76496 1304 32435710
Gastroenteritis 13.32 9.74 67 76445 14014 32423000
Coronary artery disease 13.22 9.74 66 76446 49640 32387374
Hydrocephalus 13.22 9.74 32 76480 4633 32432381
Prothrombin level abnormal 13.07 9.74 6 76506 105 32436909
Short-bowel syndrome 12.98 9.74 8 76504 259 32436755
Contraindicated product prescribed 12.94 9.74 9 76503 359 32436655
Respiratory disorder 12.85 9.74 84 76428 19333 32417681
Morganella infection 12.85 9.74 10 76502 475 32436539
Clostridium test positive 12.77 9.74 21 76491 2296 32434718
Somnolence 12.68 9.74 170 76342 103627 32333387
Sitting disability 12.67 9.74 6 76506 113 32436901
Blood luteinising hormone decreased 12.67 9.74 6 76506 113 32436901
Pharyngitis bacterial 12.66 9.74 5 76507 59 32436955
Hypothalamo-pituitary disorder 12.65 9.74 12 76500 747 32436267
Adenoidal hypertrophy 12.62 9.74 6 76506 114 32436900
Oxygen saturation abnormal 12.61 9.74 15 76497 1211 32435803
Cerebral infarction 12.59 9.74 29 76483 27585 32409429
Shunt malfunction 12.57 9.74 7 76505 187 32436827
Transient aphasia 12.53 9.74 6 76506 116 32436898
Toxic epidermal necrolysis 12.38 9.74 87 76425 20506 32416508
Phaeochromocytoma crisis 12.37 9.74 5 76507 63 32436951
Paraesthesia 12.29 9.74 201 76311 58743 32378271
Intestinal stenosis 12.26 9.74 19 76493 1976 32435038
Hepatic function abnormal 12.23 9.74 59 76453 44781 32392233
Blood corticotrophin increased 12.23 9.74 5 76507 65 32436949
Epileptic encephalopathy 12.21 9.74 6 76506 123 32436891
Trichosporon infection 12.17 9.74 12 76500 783 32436231
Wrong technique in product usage process 12.16 9.74 42 76470 35017 32401997
Foetal exposure during pregnancy 12.07 9.74 53 76459 41248 32395766
Blood creatinine increased 11.91 9.74 157 76355 95975 32341039
Administration site bruise 11.88 9.74 3 76509 6 32437008
Congenital adrenal gland hypoplasia 11.88 9.74 3 76509 6 32437008
Accidental overdose 11.78 9.74 17 76495 19322 32417692
Malignant neoplasm progression 11.73 9.74 123 76389 78373 32358641
Anal fissure 11.72 9.74 23 76489 2886 32434128
Tendonitis 11.61 9.74 46 76466 8689 32428325
Blood culture positive 11.60 9.74 32 76480 5013 32432001
Bradycardia 11.58 9.74 110 76402 71452 32365562
Drug ineffective 11.45 9.74 1049 75463 382428 32054586
Hepatitis C 11.45 9.74 9 76503 13509 32423505
Serotonin syndrome 11.45 9.74 17 76495 19100 32417914
Rectal abscess 11.45 9.74 13 76499 999 32436015
Unmasking of previously unidentified disease 11.42 9.74 11 76501 698 32436316
Hyperthyroidism 11.42 9.74 48 76464 9314 32427700
Pyrexia 11.40 9.74 887 75625 319081 32117933
Blood pressure diastolic decreased 11.32 9.74 40 76472 7157 32429857
Proteus infection 11.22 9.74 12 76500 862 32436152
Tooth injury 11.21 9.74 12 76500 863 32436151
Dactylitis 11.21 9.74 10 76502 575 32436439
Tracheobronchitis 11.18 9.74 13 76499 1025 32435989
Platelet count decreased 11.16 9.74 196 76316 114395 32322619
Febrile convulsion 11.16 9.74 10 76502 578 32436436
Pallor 11.14 9.74 92 76420 22789 32414225
Proctitis 11.07 9.74 20 76492 2358 32434656
Kounis syndrome 11.07 9.74 18 76494 1950 32435064
Melaena 11.05 9.74 43 76469 34622 32402392
Suicidal ideation 11.05 9.74 49 76463 38034 32398980
Myelitis transverse 11.05 9.74 13 76499 1038 32435976
Depressed level of consciousness 11.00 9.74 54 76458 40793 32396221
Peritonitis bacterial 11.00 9.74 8 76504 12488 32424526
Pneumonia 10.96 9.74 705 75807 354547 32082467
Abdominal abscess 10.95 9.74 28 76484 4193 32432821
Osteolysis 10.94 9.74 17 76495 1772 32435242
Respiratory depression 10.94 9.74 9 76503 13202 32423812
Antibody test abnormal 10.92 9.74 6 76506 156 32436858
Diplegia 10.89 9.74 13 76499 1054 32435960
Delirium 10.86 9.74 60 76452 43986 32393028
Therapy cessation 10.85 9.74 13 76499 16000 32421014
Hyperamylasaemia 10.81 9.74 10 76502 603 32436411
Hypernatraemia 10.66 9.74 43 76469 8190 32428824
Psychotic disorder 10.64 9.74 24 76488 22996 32414018
Cortisol abnormal 10.63 9.74 4 76508 41 32436973
Rhabdomyolysis 10.63 9.74 104 76408 67161 32369853
Functional gastrointestinal disorder 10.60 9.74 19 76493 2227 32434787
Peptic ulcer haemorrhage 10.57 9.74 9 76503 486 32436528
Leptotrichia infection 10.57 9.74 5 76507 94 32436920
Gonadotrophin deficiency 10.55 9.74 4 76508 42 32436972
Urticaria 10.54 9.74 198 76314 59416 32377598
Mental fatigue 10.42 9.74 5 76507 97 32436917
Drug-induced liver injury 10.39 9.74 26 76486 24037 32412977
Retinal scar 10.27 9.74 7 76505 270 32436744
Hypersensitivity 10.26 9.74 192 76320 57566 32379448
Inflammatory bowel disease 10.26 9.74 20 76492 2498 32434516
Spondylolisthesis 10.21 9.74 11 76501 797 32436217
Pharyngitis streptococcal 10.15 9.74 18 76494 2092 32434922
Gastric ulcer perforation 10.03 9.74 12 76500 975 32436039
Strongyloidiasis 10.02 9.74 20 76492 2541 32434473
Hepatic cirrhosis 10.02 9.74 15 76497 16794 32420220
Mucosal hyperaemia 9.99 9.74 3 76509 14 32437000
Skin injury 9.96 9.74 13 76499 1154 32435860
Haemorrhoidal haemorrhage 9.96 9.74 23 76489 3231 32433783
Arm amputation 9.94 9.74 5 76507 108 32436906
Graft versus host disease 9.93 9.74 51 76461 10755 32426259
Gastroenterostomy 9.92 9.74 4 76508 50 32436964
Cerebral haemorrhage 9.90 9.74 45 76467 34702 32402312
Secondary hypothyroidism 9.85 9.74 5 76507 110 32436904
Vitamin E deficiency 9.82 9.74 3 76509 15 32436999

Pharmacologic Action:

SourceCodeDescription
ATC A01AC03 ALIMENTARY TRACT AND METABOLISM
STOMATOLOGICAL PREPARATIONS
STOMATOLOGICAL PREPARATIONS
Corticosteroids for local oral treatment
ATC A07EA02 ALIMENTARY TRACT AND METABOLISM
ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
INTESTINAL ANTIINFLAMMATORY AGENTS
Corticosteroids acting locally
ATC C05AA01 CARDIOVASCULAR SYSTEM
VASOPROTECTIVES
AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
Corticosteroids
ATC D07AA02 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, PLAIN
Corticosteroids, weak (group I)
ATC D07XA01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, OTHER COMBINATIONS
Corticosteroids, weak, other combinations
ATC H02AB09 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
CORTICOSTEROIDS FOR SYSTEMIC USE
CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
Glucocorticoids
ATC S01BA02 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids, plain
ATC S01CB03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids/antiinfectives/mydriatics in combination
ATC S02BA01 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS
Corticosteroids
ATC D07BA04 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTISEPTICS
Corticosteroids, weak, combinations with antiseptics
ATC D07CA01 DERMATOLOGICALS
CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
CORTICOSTEROIDS, COMBINATIONS WITH ANTIBIOTICS
Corticosteroids, weak, combinations with antibiotics
ATC R01AD60 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC S01BB01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids and mydriatics in combination
ATC S01CA03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S02CA03 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
ATC S03CA04 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids and antiinfectives in combination
FDA MoA N0000175450 Corticosteroid Hormone Receptor Agonists
FDA EPC N0000175576 Corticosteroid
MeSH PA D000893 Anti-Inflammatory Agents
CHEBI has role CHEBI:35472 anti-inflammatory drugs
CHEBI has role CHEBI:49167 anti-asthmatic agents
CHEBI has role CHEBI:50857 anti-allergic agents
CHEBI has role CHEBI:75771 Mus musculus metabolite
CHEBI has role CHEBI:77746 H. sapiens metabolites
CHEBI has role CHEBI:88188 allergenic drug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Disorder of musculoskeletal system indication 928000 DOID:17
Cerebral edema indication 2032001
Otitis externa indication 3135009
Proctitis indication 3951002 DOID:3127
Keratitis indication 5888003 DOID:4677
Tinea pedis indication 6020002 DOID:12403
Berylliosis indication 8247009 DOID:10322
Psoriasis indication 9014002 DOID:8893
Ankylosing spondylitis indication 9631008 DOID:7147
Cyclitis indication 17657000
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
Seborrheic dermatitis indication 50563003 DOID:8741
Edema of larynx indication 51599000
Chronic ulcerative proctitis indication 52231000
Nephrotic syndrome indication 52254009 DOID:1184
Lichen simplex chronicus indication 53891004
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Ulcerative colitis indication 64766004 DOID:8577
Löffler's syndrome indication 64936001 DOID:9503
Iritis indication 65074000 DOID:1406
Pemphigus indication 65172003 DOID:9182
Granuloma annulare indication 65508009 DOID:3777
Tenosynovitis indication 67801009 DOID:970
Blepharoconjunctivitis indication 68659002 DOID:2456
Rheumatoid arthritis indication 69896004 DOID:7148
Hemorrhoids indication 70153002 DOID:9746
Transfusion reaction due to serum protein reaction indication 72284000
Acquired thrombocytopenia indication 74576004 DOID:11126
Iridocyclitis indication 77971008
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Tinea corporis indication 84849002
Autoimmune disease indication 85828009
Corneal abrasion indication 85848002
Infective otitis externa indication 86981007 DOID:9463
Infection by larvae of Trichinella spiralis indication 88264003
Acne vulgaris indication 88616000
Congenital hypoplastic anemia indication 88854002 DOID:1339
Pruritus ani indication 90446007
Corneal ulcer indication 91514001 DOID:8463
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
Uveitis indication 128473001 DOID:13141
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Transplanted organ rejection indication 213148006
Malignant otitis externa due to Pseudomonas aeruginosa indication 232230009
Congenital adrenal hyperplasia indication 237751000
Scalp psoriasis indication 238608008
Punctate keratopathy indication 246936005
Adrenogenital disorder indication 267395000 DOID:0050811
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Infective blepharitis indication 312219000
Bacterial keratitis indication 314557000
Disorder of eye indication 371405004 DOID:5614
Primary adrenocortical insufficiency indication 373662000
Adrenal cortical hypofunction indication 386584007 DOID:10493
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Tinea cruris indication 399029005
Erythroderma indication 399992009
Primary cutaneous T-cell lymphoma indication 400122007
Recurrent herpes simplex labialis indication 402892009
Autoimmune hemolytic anemia indication 413603009 DOID:718
Synovitis indication 416209007 DOID:2703
Aphthous ulcer of mouth indication 426965005 DOID:9663
Allergic conjunctivitis indication 473460002 DOID:11204
Post traumatic osteoarthritis indication 699262001
Itching of ear indication 699392007
Inflammatory dermatosis indication 703938007
Post-Op Ocular Inflammation indication
Mastoidectomy Cavity Infections indication
Superficial Ocular Infection indication
Gingival Disorders indication
Minor Bacterial Skin Infections indication
Synovitis due to Osteoarthritis indication
Diagnostic Test for Cushing's Syndrome indication
Transfusion Reaction Urticaria indication
Staphylococcus Aureus Otitis Externa indication
Systemic Dermatomyositis indication
Erythroblastic Anemia indication
Chronic purulent otitis media off-label use 38394007 DOID:14247
Respiratory distress syndrome in the newborn off-label use 46775006
Adrenoleukodystrophy off-label use 65389002 DOID:10588
Pityriasis simplex off-label use 200767005
Allergic otitis externa off-label use 405821001
Itching of skin off-label use 418363000
Otitis Externa Seborrhea off-label use
Neonatal Bronchopulmonary Dysplasia off-label use
Congenital Pituitary Hypoplasia off-label use
Otitis Externa Eczema off-label use
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex keratitis contraindication 9389005
Bacterial septicemia contraindication 10001005 DOID:0040085
Inactive tuberculosis contraindication 11999007
Peptic ulcer contraindication 13200003 DOID:750
Measles contraindication 14189004 DOID:8622
Esophagitis contraindication 16761005 DOID:11963
Mood swings contraindication 18963009
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Cirrhosis of liver contraindication 19943007 DOID:5082
Herpes zoster auricularis contraindication 21954000 DOID:9210
Glaucoma contraindication 23986001 DOID:1686
Abscess of intestine contraindication 24557004
Acute tuberculosis contraindication 25629007
Shock contraindication 27942005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Bullous myringitis contraindication 33528003 DOID:13791
Severe myopia contraindication 34187009
Hyperthyroidism contraindication 34486009 DOID:7998
Gastrointestinal fistula contraindication 37831005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Tuberculosis of eye contraindication 49107007
Duodenal ulcer disease contraindication 51868009 DOID:1724
Perforation of tympanic membrane contraindication 60442001
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Third degree burn injury contraindication 80247002
Hyperglycemia contraindication 80394007 DOID:4195
Decreased respiratory function contraindication 80954004
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes simplex contraindication 88594005 DOID:8566
Kidney disease contraindication 90708001 DOID:557
Disorder of mucous membrane contraindication 95351003
Bilateral cataracts contraindication 95722004
Open wound contraindication 125643001
Eye infection contraindication 128351009
Seizure disorder contraindication 128613002
Bacterial infection of eye contraindication 128984004
Disorder of muscle contraindication 129565002 DOID:423
Tuberculosis of ear contraindication 186269001
Ophthalmic herpes simplex contraindication 186542001
Heart block contraindication 233916004
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Condyloma acuminatum contraindication 240542006 DOID:11168
Telangiectasia disorder contraindication 247479008
Diverticulitis of gastrointestinal tract contraindication 271366000
Injury of eye region contraindication 282752000
Varicella-zoster virus infection contraindication 309465005
Viral eye infection contraindication 312132001
Viral ear infection contraindication 312137007
Fungal ear infection contraindication 312148000
Infective otitis media contraindication 312218008
Skin irritation contraindication 367466007
Vaccinia keratitis contraindication 397552005
Gastric ulcer contraindication 397825006 DOID:10808
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Blister contraindication 417237009
Denuded skin contraindication 418242004
Exposure to varicella contraindication 444453009

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.31 acidic
pKa2 13.65 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
5%;1% XERESE BAUSCH N022436 July 31, 2009 RX CREAM TOPICAL 7223387 Nov. 13, 2022 COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
5%;1% XERESE BAUSCH N022436 July 31, 2009 RX CREAM TOPICAL 7223387 Nov. 13, 2022 NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY

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 EC50 8.50 WOMBAT-PK CHEMBL
Annexin A1 Cytosolic other WOMBAT-PK
Mineralocorticoid receptor Nuclear hormone receptor AGONIST IC50 9.95 IUPHAR
Nitric oxide synthase, inducible Enzyme IC50 8 WOMBAT-PK
Corticosteroid-binding globulin Secreted Ki 7.88 WOMBAT-PK
Sex hormone-binding globulin Secreted Kd 6.20 CHEMBL
Glucocorticoid receptor Transcription factor Kd 7.37 CHEMBL

External reference:

IDSource
4017941 VUID
N0000146291 NUI
D00088 KEGG_DRUG
4017941 VANDF
C0020268 UMLSCUI
CHEBI:17650 CHEBI
HCY PDB_CHEM_ID
CHEMBL389621 ChEMBL_ID
DB00741 DRUGBANK_ID
D006854 MESH_DESCRIPTOR_UI
5754 PUBCHEM_CID
2868 IUPHAR_LIGAND_ID
38 INN_ID
WI4X0X7BPJ UNII
202643 RXNORM
174 MMSL
2500 MMSL
4837 MMSL
d00254 MMSL
002147 NDDF
16602005 SNOMEDCT_US
396458002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0012 TABLET 5 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0031 TABLET 10 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0044 TABLET 20 mg ORAL NDA 15 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 10 mg AURICULAR (OTIC) NDA 16 sections
Aquanil HC HUMAN OTC DRUG LABEL 1 0096-0732 LOTION 0.01 g TOPICAL OTC monograph not final 10 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0471 OINTMENT 1 g TOPICAL OTC monograph not final 13 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-0541 CREAM 1 g TOPICAL OTC monograph not final 13 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-0793 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0973 CREAM 1 g TOPICAL OTC monograph not final 13 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-1369 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Basic Case Hydrocortisone Anti-Itch HUMAN OTC DRUG LABEL 1 0113-7006 CREAM 1 g TOPICAL OTC monograph not final 13 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-7369 CREAM 1 g TOPICAL OTC monograph not final 13 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1696 TABLET 5 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1697 TABLET 10 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1700 TABLET 20 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0014 CREAM 5 mg TOPICAL OTC monograph final 9 sections
hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0015 CREAM 10 mg TOPICAL ANDA 19 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0016 OINTMENT 5 mg TOPICAL OTC monograph final 9 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0020 OINTMENT 10 mg TOPICAL ANDA 18 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0080 CREAM 25 mg TOPICAL ANDA 17 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0146 OINTMENT 25 mg TOPICAL ANDA 17 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0288 LOTION 25 mg TOPICAL ANDA 18 sections
Texacort HUMAN PRESCRIPTION DRUG LABEL 1 0178-0455 SOLUTION 25 mg TOPICAL ANDA 20 sections
KAISER PERMANENTEHydrocortisone HUMAN OTC DRUG LABEL 1 0179-8711 OINTMENT 1 g TOPICAL OTC monograph not final 15 sections
Xerese HUMAN PRESCRIPTION DRUG LABEL 2 0187-5104 CREAM 10 mg TOPICAL NDA 26 sections
Alacort HUMAN PRESCRIPTION DRUG LABEL 1 0316-0126 CREAM 10 mg TOPICAL ANDA 19 sections
Alacort HUMAN PRESCRIPTION DRUG LABEL 1 0316-0128 CREAM 25 mg TOPICAL ANDA 19 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0316-0186 CREAM 10 mg TOPICAL ANDA 19 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0316-0193 CREAM 25 mg TOPICAL ANDA 19 sections
Sarna Whipped Foam HUMAN OTC DRUG LABEL 1 0316-0291 AEROSOL, FOAM 10 mg TOPICAL OTC monograph not final 11 sections