hydrocortisone 🐶 Veterinary Use | 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 468.81 9.37 1300 143497 168257 50292070
Pericarditis 372.56 9.37 745 144052 77944 50382383
Anti-cyclic citrullinated peptide antibody positive 365.45 9.37 694 144103 69893 50390434
Completed suicide 347.00 9.37 6 144791 131883 50328444
Wound 328.24 9.37 847 143950 104947 50355380
Rheumatoid factor positive 312.71 9.37 533 144264 49326 50411001
Adrenocortical insufficiency acute 312.22 9.37 127 144670 1317 50459010
Discomfort 300.16 9.37 832 143965 107548 50352779
Hand deformity 271.33 9.37 763 144034 99436 50360891
Glossodynia 235.56 9.37 797 144000 114772 50345555
Duodenal ulcer perforation 234.17 9.37 447 144350 45164 50415163
Helicobacter infection 222.56 9.37 460 144337 49242 50411085
Synovitis 221.33 9.37 818 143979 123047 50337280
Toxicity to various agents 213.24 9.37 177 144620 212322 50248005
Intentional product use issue 204.51 9.37 582 144215 76336 50383991
Pemphigus 200.96 9.37 777 144020 119389 50340938
Systemic lupus erythematosus 200.15 9.37 865 143932 139757 50320570
Adrenal insufficiency 188.44 9.37 218 144579 14025 50446302
Hepatic enzyme increased 182.59 9.37 828 143969 136552 50323775
Drug hypersensitivity 181.87 9.37 1285 143512 249725 50210602
Arthropathy 181.81 9.37 913 143884 156993 50303334
Steroid withdrawal syndrome 173.66 9.37 63 144734 464 50459863
Hypersensitivity 164.35 9.37 1116 143681 214045 50246282
Death 153.92 9.37 451 144346 324928 50135399
Swelling 141.11 9.37 1021 143776 199851 50260476
Product use issue 136.77 9.37 812 143985 148663 50311664
Drug abuse 130.13 9.37 11 144786 59835 50400492
Abdominal discomfort 120.21 9.37 1099 143698 230542 50229785
Colitis ulcerative 114.72 9.37 187 144610 16667 50443660
Blister 114.25 9.37 516 144281 84902 50375425
Intentional overdose 108.75 9.37 23 144774 62481 50397846
Fall 108.61 9.37 541 144256 334391 50125936
Febrile bone marrow aplasia 106.85 9.37 110 144687 6201 50454126
Alopecia 103.98 9.37 1115 143682 243932 50216395
Drug intolerance 98.60 9.37 1009 143788 218095 50242232
Rheumatic fever 97.46 9.37 174 144623 16693 50443634
Craniopharyngioma 96.50 9.37 30 144767 127 50460200
Overdose 96.34 9.37 86 144711 99641 50360686
Maternal exposure during pregnancy 93.70 9.37 779 144018 158999 50301328
Rash 92.76 9.37 1761 143036 435710 50024617
Condition aggravated 92.61 9.37 1275 143522 295783 50164544
Blood pressure fluctuation 92.18 9.37 268 144529 35555 50424772
Drug interaction 84.21 9.37 291 144506 199330 50260997
Swollen joint count increased 82.83 9.37 151 144646 14722 50445605
Hypofibrinogenaemia 82.75 9.37 47 144750 1065 50459262
Irritable bowel syndrome 80.53 9.37 326 144471 51115 50409212
Sleep disorder due to general medical condition, insomnia type 74.96 9.37 229 144568 31218 50429109
Pituitary tumour benign 73.89 9.37 52 144745 1729 50458598
Secondary adrenocortical insufficiency 73.64 9.37 44 144753 1099 50459228
Muscle injury 69.47 9.37 249 144548 36862 50423465
Hip arthroplasty 69.21 9.37 218 144579 30211 50430116
Folliculitis 66.58 9.37 255 144542 38970 50421357
Product dose omission issue 62.93 9.37 291 144506 183547 50276780
Type 2 diabetes mellitus 59.60 9.37 225 144572 34150 50426177
Device expulsion 55.82 9.37 8 144789 28814 50431513
Suicide attempt 53.15 9.37 42 144755 51690 50408637
Joint swelling 52.00 9.37 988 143809 244298 50216029
Off label use 51.73 9.37 1747 143050 472679 49987648
Knee arthroplasty 48.23 9.37 217 144580 35629 50424698
Contraindicated product administered 47.78 9.37 643 144154 148315 50312012
Inappropriate schedule of product administration 47.40 9.37 360 144437 71471 50388856
Injury 46.74 9.37 269 144528 48656 50411671
Cardiac failure congestive 45.82 9.37 109 144688 84273 50376054
Cortisol decreased 45.34 9.37 31 144766 983 50459344
Adrenal suppression 44.63 9.37 29 144768 843 50459484
Sedation 44.40 9.37 16 144781 30594 50429733
Drug level below therapeutic 44.11 9.37 54 144743 3686 50456641
Cerebrovascular accident 44.07 9.37 132 144665 94548 50365779
Urticaria thermal 43.43 9.37 17 144780 158 50460169
Frequent bowel movements 42.62 9.37 111 144686 13807 50446520
Hyperadrenocorticism 42.30 9.37 20 144777 305 50460022
Acute kidney injury 41.71 9.37 434 144363 227624 50232703
Poor venous access 40.84 9.37 91 144706 10249 50450078
Injection site reaction 40.59 9.37 50 144747 49982 50410345
Anaemia 40.45 9.37 495 144302 251961 50208366
Drug tolerance decreased 38.90 9.37 83 144714 9077 50451250
Hypothalamic pituitary adrenal axis suppression 38.45 9.37 15 144782 138 50460189
Musculoskeletal injury 37.81 9.37 14 144783 110 50460217
Wrong technique in product usage process 37.61 9.37 63 144734 55447 50404880
Injection site erythema 37.43 9.37 101 144696 74835 50385492
Myocardial infarction 37.34 9.37 130 144667 88897 50371430
Female genital tract fistula 37.03 9.37 49 144748 3617 50456710
Nausea 36.75 9.37 1648 143149 703750 49756577
Cognitive disorder 35.89 9.37 44 144753 44079 50416248
Serotonin syndrome 35.71 9.37 13 144784 24700 50435627
Hypothalamo-pituitary disorder 35.54 9.37 23 144774 664 50459663
Intentional self-injury 35.41 9.37 11 144786 23101 50437226
Malignant neoplasm progression 34.64 9.37 91 144706 68033 50392294
Hypopituitarism 34.48 9.37 25 144772 872 50459455
Insulin-like growth factor increased 34.21 9.37 24 144773 794 50459533
Live birth 34.10 9.37 114 144683 16294 50444033
Human bocavirus infection 33.79 9.37 18 144779 358 50459969
Coma 33.72 9.37 70 144727 56809 50403518
Interstitial lung disease 33.63 9.37 63 144734 53113 50407214
Syncope 33.49 9.37 166 144631 102836 50357491
Blood cholesterol increased 33.26 9.37 271 144526 54944 50405383
Treatment failure 32.85 9.37 565 144232 137072 50323255
Injection site swelling 32.59 9.37 43 144754 41730 50418597
Respiratory arrest 32.58 9.37 23 144774 29986 50430341
Neoplasm recurrence 32.58 9.37 37 144760 2332 50457995
Faecal calprotectin increased 31.94 9.37 35 144762 2120 50458207
Intentional product misuse 31.69 9.37 53 144744 46681 50413646
Blood creatinine increased 31.41 9.37 112 144685 76048 50384279
Renal impairment 31.38 9.37 111 144686 75550 50384777
Injection site pain 31.11 9.37 188 144609 110836 50349491
Breast cancer 30.63 9.37 47 144750 42843 50417484
Cardio-respiratory arrest 30.55 9.37 68 144729 53824 50406503
Therapeutic product effect incomplete 30.03 9.37 147 144650 91368 50368959
Cardiac failure 29.93 9.37 114 144683 75926 50384401
Chronic obstructive pulmonary disease 29.82 9.37 68 144729 53367 50406960
Heart rate irregular 29.73 9.37 122 144675 19238 50441089
Atrial fibrillation 29.72 9.37 170 144627 101575 50358752
Full blood count abnormal 29.50 9.37 15 144782 23373 50436954
Body temperature fluctuation 29.17 9.37 32 144765 1941 50458386
Suicidal ideation 28.92 9.37 73 144724 55312 50405015
Asphyxia 28.84 9.37 54 144743 5373 50454954
Colitis 28.80 9.37 199 144598 38330 50421997
Tendonitis 28.67 9.37 109 144688 16596 50443731
Therapeutic product effect decreased 28.09 9.37 546 144251 135504 50324823
Perioral dermatitis 27.87 9.37 12 144785 145 50460182
Hypophysitis 27.67 9.37 28 144769 1546 50458781
Drug withdrawal syndrome 27.52 9.37 19 144778 25062 50435265
Platelet count decreased 27.47 9.37 172 144625 100554 50359773
Balance disorder 27.03 9.37 107 144690 70483 50389844
Gastrointestinal haemorrhage 26.91 9.37 113 144684 73208 50387119
Rheumatoid arthritis 26.72 9.37 413 144384 202137 50258190
Haemoglobin decreased 26.67 9.37 234 144563 126982 50333345
Electrocardiogram QT prolonged 26.61 9.37 69 144728 51817 50408510
Impaired healing 26.08 9.37 310 144487 69476 50390851
Normal tension glaucoma 25.90 9.37 8 144789 33 50460294
Therapeutic response shortened 25.85 9.37 62 144735 7327 50453000
Insulin-like growth factor decreased 25.68 9.37 15 144782 359 50459968
Natural killer-cell leukaemia 25.63 9.37 10 144787 92 50460235
Anal fistula 25.19 9.37 35 144762 2707 50457620
Urticaria 24.76 9.37 514 144283 129047 50331280
Red blood cell sedimentation rate abnormal 24.64 9.37 8 144789 16335 50443992
Faecal volume decreased 24.43 9.37 11 144786 149 50460178
Clostridium difficile colitis 24.31 9.37 108 144689 17634 50442693
Hospitalisation 24.14 9.37 106 144691 67831 50392496
Antithrombin III 23.98 9.37 11 144786 156 50460171
Depressed level of consciousness 23.76 9.37 73 144724 51880 50408447
Oedema peripheral 23.67 9.37 314 144483 157647 50302680
Perfume sensitivity 23.49 9.37 17 144780 591 50459736
Lactic acidosis 23.39 9.37 37 144760 33318 50427009
Accidental exposure to product 23.33 9.37 19 144778 23038 50437289
Anal fissure 23.26 9.37 36 144761 3069 50457258
Proctalgia 23.19 9.37 47 144750 4956 50455371
Drug level decreased 23.05 9.37 55 144742 6478 50453849
Tendon pain 22.97 9.37 35 144762 2943 50457384
Blood creatine phosphokinase increased 22.84 9.37 25 144772 26342 50433985
Lower respiratory tract infection 22.77 9.37 391 144406 94810 50365517
Bradycardia 22.60 9.37 101 144696 64325 50396002
Mucous stools 22.24 9.37 34 144763 2868 50457459
Somnolence 22.17 9.37 311 144486 154674 50305653
Allergy test positive 22.04 9.37 14 144783 391 50459936
Wheezing 22.04 9.37 273 144524 61774 50398553
Metastases to bone 22.02 9.37 12 144785 17983 50442344
Gastroenteritis norovirus 21.87 9.37 26 144771 1721 50458606
Macular degeneration 21.77 9.37 7 144790 14381 50445946
Maternal exposure timing unspecified 21.75 9.37 38 144759 3582 50456745
Ill-defined disorder 21.40 9.37 245 144552 54409 50405918
Cardiac disorder 21.40 9.37 58 144739 42921 50417406
Pneumonia 21.28 9.37 876 143921 377525 50082802
Weight increased 21.27 9.37 741 144056 201150 50259177
Deep vein thrombosis postoperative 21.21 9.37 25 144772 1640 50458687
Haematochezia 21 9.37 190 144607 39692 50420635
Pruritus 20.95 9.37 1002 143795 282566 50177761
Excessive eye blinking 20.73 9.37 19 144778 927 50459400
Airway peak pressure increased 20.70 9.37 12 144785 283 50460044
Adrenal disorder 20.67 9.37 22 144775 1289 50459038
Secondary immunodeficiency 20.64 9.37 21 144776 1167 50459160
Melaena 20.60 9.37 28 144769 26836 50433491
Febrile neutropenia 20.50 9.37 393 144404 97274 50363053
Eczema 20.50 9.37 123 144674 22579 50437748
Eczema herpeticum 20.46 9.37 9 144788 115 50460212
Disease progression 20.24 9.37 176 144621 95690 50364637
Diaphragm muscle weakness 20.19 9.37 6 144791 21 50460306
Tendon rupture 19.88 9.37 55 144742 7089 50453238
Femur fracture 19.85 9.37 49 144748 37415 50422912
Fistula 19.72 9.37 60 144737 8158 50452169
Neuroleptic malignant syndrome 19.55 9.37 4 144793 11126 50449201
Arteriosclerosis coronary artery 19.51 9.37 57 144740 7579 50452748
Arthralgia 19.36 9.37 1481 143316 437221 50023106
Anal abscess 19.25 9.37 37 144760 3754 50456573
Meningitis candida 19.24 9.37 7 144790 52 50460275
Skin weeping 19.05 9.37 13 144784 411 50459916
Neutropenia 18.73 9.37 304 144493 147661 50312666
Hepatic function abnormal 18.72 9.37 41 144756 32640 50427687
White blood cell count decreased 18.60 9.37 229 144568 116493 50343834
Dry eye 18.60 9.37 40 144757 32055 50428272
Diabetes insipidus 18.54 9.37 28 144769 2336 50457991
Multiple sclerosis relapse 18.51 9.37 62 144735 42902 50417425
Loss of consciousness 18.47 9.37 200 144597 104153 50356174
Drug level above therapeutic 18.38 9.37 37 144760 3883 50456444
Hyperemesis gravidarum 18.33 9.37 14 144783 529 50459798
Natural killer cell count decreased 18.33 9.37 6 144791 31 50460296
Product quality issue 18.27 9.37 38 144759 30820 50429507
Therapy cessation 18.10 9.37 29 144768 25982 50434345
Labelled drug-drug interaction medication error 17.92 9.37 4 144793 10473 50449854
B-lymphocyte count increased 17.79 9.37 8 144789 108 50460219
Orthostatic hypotension 17.71 9.37 36 144761 29445 50430882
Pituitary tumour recurrent 17.70 9.37 7 144790 67 50460260
Enterococcal sepsis 17.68 9.37 20 144777 1255 50459072
Osteonecrosis of jaw 17.66 9.37 42 144755 32484 50427843
Unevaluable event 17.52 9.37 70 144727 45996 50414331
X-ray abnormal 17.47 9.37 29 144768 2623 50457704
Hepatotoxicity 17.44 9.37 32 144765 27194 50433133
Leukoencephalopathy 17.44 9.37 36 144761 3847 50456480
Acute myocardial infarction 17.37 9.37 36 144761 29237 50431090
Dizziness 17.36 9.37 812 143985 345557 50114770
Tremor 17.36 9.37 228 144569 114675 50345652
Rhinovirus infection 17.34 9.37 34 144763 3500 50456827
Drug specific antibody present 17.26 9.37 33 144764 3335 50456992
Anti-cyclic citrullinated peptide antibody 17.20 9.37 22 144775 1570 50458757
Vaginal flatulence 17.02 9.37 10 144787 242 50460085
Cerebral microangiopathy 16.94 9.37 10 144787 244 50460083
Septic shock 16.76 9.37 243 144554 56932 50403395
Product storage error 16.72 9.37 7 144790 12217 50448110
Neutropenic infection 16.71 9.37 18 144779 1069 50459258
Mastocytosis 16.69 9.37 13 144784 506 50459821
Dry skin 16.64 9.37 193 144604 42998 50417329
Vertigo 16.57 9.37 84 144713 51748 50408579
Tuberculosis gastrointestinal 16.54 9.37 11 144786 333 50459994
Asthenia 16.38 9.37 746 144051 318296 50142031
Skin fragility 16.30 9.37 13 144784 524 50459803
Salpingo-oophorectomy unilateral 16.21 9.37 13 144784 528 50459799
Gastrointestinal disorder 16.20 9.37 369 144428 94087 50366240
Stomatitis 16.19 9.37 392 144405 100952 50359375
Excessive skin 16.09 9.37 8 144789 137 50460190
Increased bronchial secretion 15.96 9.37 21 144776 1541 50458786
Hypogonadism 15.94 9.37 7 144790 89 50460238
Rhabdomyolysis 15.68 9.37 58 144739 38969 50421358
Abdominal pain 15.63 9.37 826 143971 235402 50224925
Leukopenia 15.61 9.37 121 144676 67407 50392920
Secondary hypogonadism 15.34 9.37 7 144790 98 50460229
Adverse event 15.30 9.37 192 144605 43571 50416756
Abortion spontaneous 14.94 9.37 65 144732 41707 50418620
Product prescribing error 14.94 9.37 23 144774 20938 50439389
Complication associated with device 14.92 9.37 12 144785 14643 50445684
PO2 decreased 14.79 9.37 19 144778 1362 50458965
Liver function test abnormal 14.67 9.37 71 144726 44268 50416059
Faecal calprotectin abnormal 14.60 9.37 6 144791 64 50460263
Lupus vulgaris 14.59 9.37 13 144784 611 50459716
Fluid retention 14.58 9.37 85 144712 50564 50409763
CSF lymphocyte count abnormal 14.58 9.37 3 144794 0 50460327
Hepatitis 14.52 9.37 44 144753 31409 50428918
Cerebral vasoconstriction 14.51 9.37 16 144781 976 50459351
Prescribed overdose 14.41 9.37 81 144716 14519 50445808
Accidental overdose 14.34 9.37 21 144776 19512 50440815
Dislocation of vertebra 14.31 9.37 29 144768 3058 50457269
Medication error 14.28 9.37 54 144743 36050 50424277
Hypernatraemia 14.11 9.37 45 144752 6276 50454051
Depression 14.04 9.37 363 144434 165060 50295267
Diarrhoea haemorrhagic 13.94 9.37 51 144746 7624 50452703
Fibromyalgia 13.92 9.37 193 144604 44785 50415542
Pneumatosis intestinalis 13.86 9.37 23 144774 2080 50458247
Hepatic cirrhosis 13.80 9.37 18 144779 17559 50442768
Injection site pruritus 13.78 9.37 64 144733 40347 50419980
Cardiac arrest 13.75 9.37 163 144634 83488 50376839
Adjustment disorder with depressed mood 13.72 9.37 27 144770 2787 50457540
Thrombocytopenia 13.41 9.37 271 144526 127402 50332925
Pseudomonas infection 13.37 9.37 58 144739 9372 50450955
Myoclonus 13.35 9.37 13 144784 14457 50445870
Vaginal discharge 13.28 9.37 39 144758 5201 50455126
Hypercapnia 13.25 9.37 36 144761 4591 50455736
Pseudostroke 13.25 9.37 4 144793 15 50460312
Skin ulcer 13.22 9.37 54 144743 35264 50425063
Status asthmaticus 13.17 9.37 14 144783 819 50459508
Hypertensive crisis 13.11 9.37 11 144786 13143 50447184
Creatinine renal clearance decreased 13.04 9.37 9 144788 11872 50448455
Device difficult to use 12.99 9.37 6 144791 9880 50450447
Aspergillus infection 12.96 9.37 46 144751 6775 50453552
Lung hyperinflation 12.96 9.37 16 144781 1102 50459225
Aborted pregnancy 12.91 9.37 5 144792 45 50460282
Pulmonary arterial hypertension 12.91 9.37 24 144773 20295 50440032
Tendon disorder 12.91 9.37 39 144758 5283 50455044
Coronary artery dissection 12.90 9.37 13 144784 714 50459613
Skin injury 12.86 9.37 19 144778 1555 50458772
Bronchitis 12.85 9.37 215 144582 103944 50356383
Bacterial infection 12.71 9.37 85 144712 16196 50444131
PCO2 increased 12.67 9.37 16 144781 1127 50459200
Shared psychotic disorder 12.67 9.37 4 144793 18 50460309
Myelosuppression 12.64 9.37 12 144785 13505 50446822
Hyperhidrosis 12.58 9.37 180 144617 89246 50371081
Brachycephaly 12.50 9.37 4 144793 19 50460308
Akathisia 12.46 9.37 4 144793 8225 50452102
Gastrointestinal scarring 12.45 9.37 8 144789 228 50460099
Ankle fracture 12.45 9.37 16 144781 15706 50444621
Abnormal faeces 12.37 9.37 33 144764 4163 50456164
Device dislocation 12.36 9.37 27 144770 21519 50438808
Schizophrenia 12.31 9.37 3 144794 7394 50452933
Autoimmune nephritis 12.29 9.37 9 144788 319 50460008
Injection site rash 12.26 9.37 17 144780 16160 50444167
Hypoperfusion 12.25 9.37 17 144780 1313 50459014
Transient ischaemic attack 12.21 9.37 49 144748 32161 50428166
Parkinsonism 12.21 9.37 5 144792 8842 50451485
Agitation 12.17 9.37 96 144701 53288 50407039
Pneumatosis 12.16 9.37 10 144787 421 50459906
Herpes simplex hepatitis 12.16 9.37 9 144788 324 50460003
Glucocorticoid deficiency 12.15 9.37 8 144789 238 50460089
Dyskinesia 12.14 9.37 40 144757 27821 50432506
Breast cancer stage III 12.13 9.37 28 144769 3228 50457099
Anorectal ulcer 12.11 9.37 5 144792 54 50460273
Ascites 12.11 9.37 57 144740 35804 50424523
Blood corticotrophin decreased 12.06 9.37 8 144789 241 50460086
Optic glioma 12.05 9.37 3 144794 4 50460323
Blood growth hormone increased 12.04 9.37 10 144787 427 50459900
Cerebrospinal fluid leakage 11.88 9.37 14 144783 918 50459409
Non-consummation 11.87 9.37 5 144792 57 50460270
Bronchopulmonary aspergillosis 11.78 9.37 48 144749 7544 50452783
Herpes simplex 11.69 9.37 46 144751 7116 50453211
Palmar-plantar erythrodysaesthesia syndrome 11.69 9.37 25 144772 20073 50440254
Drug eruption 11.64 9.37 32 144765 23574 50436753
Blood parathyroid hormone decreased 11.61 9.37 3 144794 7111 50453216
Eosinophilic oesophagitis 11.61 9.37 8 144789 257 50460070
Renal failure 11.60 9.37 225 144572 106408 50353919
Enterobacter infection 11.58 9.37 20 144777 1868 50458459
Extrapyramidal disorder 11.54 9.37 10 144787 11760 50448567
Enteritis 11.48 9.37 45 144752 6950 50453377
Musculoskeletal disorder 11.46 9.37 20 144777 17329 50442998
Nasopharyngitis 11.46 9.37 668 144129 192259 50268068
Musculoskeletal stiffness 11.45 9.37 463 144334 128018 50332309
Coronary artery disease 11.41 9.37 45 144752 29681 50430646
Geotrichum infection 11.41 9.37 10 144787 460 50459867
Contusion 11.36 9.37 410 144387 111773 50348554
Loss of employment 11.34 9.37 18 144779 1568 50458759
Pyoderma gangrenosum 11.28 9.37 25 144772 2806 50457521
Product use in unapproved indication 11.18 9.37 421 144376 115398 50344929
Autoimmune disorder 11.16 9.37 40 144757 5920 50454407
Rheumatoid nodule 11.11 9.37 12 144785 12723 50447604
Ocular procedural complication 11.11 9.37 9 144788 371 50459956
International normalised ratio increased 11.09 9.37 75 144722 43077 50417250
Insomnia 11.07 9.37 399 144398 174466 50285861
Sinusitis fungal 11.01 9.37 16 144781 1290 50459037
Astrocytoma 10.96 9.37 5 144792 70 50460257
Osteopenia 10.90 9.37 20 144777 16998 50443329
Metastases to liver 10.88 9.37 26 144771 20078 50440249
Visual pathway disorder 10.85 9.37 4 144793 31 50460296
Crohn's disease 10.84 9.37 34 144763 4699 50455628
Respiratory depression 10.84 9.37 11 144786 11999 50448328
Erythema nodosum 10.81 9.37 30 144767 3873 50456454
Chronic kidney disease 10.79 9.37 68 144729 39703 50420624
Pleural effusion 10.75 9.37 166 144631 81288 50379039
Drug resistance 10.73 9.37 24 144773 18965 50441362
Dystonia 10.67 9.37 11 144786 11915 50448412
Heart rate decreased 10.65 9.37 155 144642 36342 50423985
Rectal abscess 10.64 9.37 14 144783 1028 50459299
Aplastic anaemia 10.63 9.37 47 144750 7656 50452671
Lip dry 10.61 9.37 34 144763 4753 50455574
Therapeutic reaction time decreased 10.59 9.37 16 144781 1336 50458991
Feeding intolerance 10.56 9.37 10 144787 509 50459818
Basal cell carcinoma 10.55 9.37 33 144764 23323 50437004
Pituitary infarction 10.53 9.37 4 144793 34 50460293
Toxic skin eruption 10.50 9.37 10 144787 11241 50449086
Herpes zoster 10.49 9.37 141 144656 70645 50389682
Uterine cyst 10.47 9.37 9 144788 403 50459924
Mydriasis 10.45 9.37 9 144788 10618 50449709
Plasma cell myeloma 10.45 9.37 50 144747 31272 50429055
Prescription drug used without a prescription 10.42 9.37 18 144779 1682 50458645
Arrhythmia 10.42 9.37 54 144743 33078 50427249
Myelodysplastic syndrome 10.41 9.37 17 144780 15115 50445212
Anticipatory anxiety 10.37 9.37 8 144789 307 50460020
Oesophageal adenocarcinoma recurrent 10.33 9.37 4 144793 36 50460291
Exposure during pregnancy 10.31 9.37 434 144363 120581 50339746
Staphylococcal infection 10.29 9.37 151 144646 35465 50424862
Antithrombin III decreased 10.26 9.37 7 144790 221 50460106
Colonic abscess 10.24 9.37 12 144785 782 50459545
Subacute combined cord degeneration 10.24 9.37 7 144790 222 50460105
Weaning failure 10.21 9.37 8 144789 314 50460013
Bone erosion 10.21 9.37 11 144786 11676 50448651
Therapy interrupted 10.18 9.37 27 144770 20125 50440202
Thyroglossal cyst infection 10.14 9.37 4 144793 38 50460289
Pituitary haemorrhage 10.14 9.37 5 144792 84 50460243
Respiratory acidosis 10.07 9.37 39 144758 5989 50454338
Metastases to lung 10.05 9.37 10 144787 11010 50449317
Tuberous sclerosis complex 10.04 9.37 5 144792 86 50460241
Encephalitis autoimmune 10.01 9.37 15 144782 1243 50459084
Pneumopericardium 9.87 9.37 4 144793 41 50460286
Toothache 9.83 9.37 21 144776 16873 50443454
Blood gonadotrophin decreased 9.78 9.37 3 144794 12 50460315
Renal disorder 9.71 9.37 43 144754 27462 50432865
Choriocarcinoma 9.71 9.37 4 144793 43 50460284
Genital rash 9.70 9.37 9 144788 446 50459881
Feeling abnormal 9.70 9.37 279 144518 125213 50335114
Haematuria 9.69 9.37 39 144758 25574 50434753
Pulmonary hypertension 9.66 9.37 56 144741 33361 50426966
Underdose 9.62 9.37 28 144769 20250 50440077
Liver injury 9.62 9.37 111 144686 24695 50435632
Dysarthria 9.62 9.37 65 144732 37338 50422989
Epistaxis 9.62 9.37 127 144670 63827 50396500
Blood smear test abnormal 9.54 9.37 5 144792 96 50460231
Steroid dependence 9.53 9.37 8 144789 347 50459980
Muscle spasticity 9.48 9.37 22 144775 17162 50443165
Injection site bruising 9.40 9.37 64 144733 36704 50423623
Endocarditis bacterial 9.39 9.37 10 144787 586 50459741
Vaccination site inflammation 9.39 9.37 4 144793 47 50460280

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
Blood pressure fluctuation 190.82 9.93 244 74937 19650 29479696
Adrenal insufficiency 181.72 9.93 180 75001 10934 29488412
Completed suicide 173.81 9.93 15 75166 90231 29409115
Drug abuse 166.27 9.93 9 75172 79874 29419472
Craniopharyngioma 165.31 9.93 51 75130 242 29499104
Toxicity to various agents 159.41 9.93 125 75056 173536 29325810
Infusion related reaction 154.16 9.93 343 74838 43543 29455803
Adrenocortical insufficiency acute 149.08 9.93 71 75110 1249 29498097
Death 140.93 9.93 426 74755 341658 29157688
Graft loss 138.43 9.93 59 75122 789 29498557
Off label use 133.58 9.93 1256 73925 299544 29199802
Intentional product use issue 132.56 9.93 317 74864 42181 29457165
Colitis ulcerative 121.46 9.93 156 75025 12613 29486733
Febrile bone marrow aplasia 120.06 9.93 119 75062 7232 29492114
Serum sickness 118.65 9.93 67 75114 1698 29497648
Hypofibrinogenaemia 98.26 9.93 56 75125 1445 29497901
Frequent bowel movements 94.42 9.93 117 75064 9122 29490224
Febrile neutropenia 91.53 9.93 542 74639 111698 29387648
Inappropriate schedule of product administration 75.67 9.93 267 74914 44205 29455141
Product use issue 75.12 9.93 294 74887 51150 29448196
Leukoencephalopathy 74.90 9.93 68 75113 3699 29495647
Condition aggravated 73.89 9.93 629 74552 145666 29353680
Diabetes insipidus 73.56 9.93 56 75125 2378 29496968
Hypopituitarism 73.54 9.93 49 75132 1681 29497665
Intentional overdose 67.51 9.93 9 75172 38519 29460827
Heart rate irregular 67.07 9.93 120 75061 12997 29486349
Adrenal suppression 64.34 9.93 30 75151 502 29498844
Steroid withdrawal syndrome 58.68 9.93 22 75159 205 29499141
Drug interaction 56.44 9.93 284 74897 197101 29302245
Aplastic anaemia 55.18 9.93 81 75100 7429 29491917
Pituitary tumour benign 53.27 9.93 30 75151 756 29498590
Heart rate decreased 52.62 9.93 161 75020 24751 29474595
Mucosal inflammation 50.59 9.93 186 74995 31409 29467937
Interstitial lung disease 49.80 9.93 44 75137 57674 29441672
Impaired quality of life 49.58 9.93 46 75135 2573 29496773
Drug specific antibody present 48.52 9.93 45 75136 2516 29496830
Septic shock 48.30 9.93 298 74883 62262 29437084
Insulin-like growth factor decreased 48.20 9.93 20 75161 249 29499097
Faecal calprotectin increased 47.36 9.93 36 75145 1525 29497821
Tendon pain 45.58 9.93 43 75138 2457 29496889
Body temperature fluctuation 45.23 9.93 34 75147 1416 29497930
Pseudostroke 43.19 9.93 12 75169 36 29499310
Hypertriglyceridaemia 42.93 9.93 72 75109 7403 29491943
Overdose 42.32 9.93 87 75094 79732 29419614
Tendon rupture 42.13 9.93 65 75116 6230 29493116
Drug level below therapeutic 40.32 9.93 52 75129 4219 29495127
Tendon disorder 40.25 9.93 40 75141 2438 29496908
Fistula 40.05 9.93 57 75124 5082 29494264
Suicide attempt 38.90 9.93 19 75162 34091 29465255
Neoplasm recurrence 37.96 9.93 35 75146 1942 29497404
Insulin-like growth factor increased 36.78 9.93 27 75154 1084 29498262
Colitis 36.58 9.93 167 75014 31081 29468265
Hypophysitis 36.14 9.93 34 75147 1936 29497410
Fall 36.08 9.93 283 74898 176895 29322451
Myocardial infarction 36.04 9.93 151 75030 110145 29389201
Bronchiectasis 34.63 9.93 61 75120 6524 29492822
Cortisol decreased 34.03 9.93 23 75158 808 29498538
Flushing 33.97 9.93 155 75026 28837 29470509
Therapeutic response shortened 32.80 9.93 50 75131 4741 29494605
Pelvic abscess 32.51 9.93 23 75158 871 29498475
Myelopathy 32.31 9.93 32 75149 1942 29497404
Arthralgia 31.07 9.93 513 74668 139104 29360242
Crohn's disease 30.57 9.93 38 75143 2971 29496375
Hypertrophic cardiomyopathy 30.55 9.93 22 75159 857 29498489
Epiphysiolysis 30.17 9.93 11 75170 94 29499252
Lichen planus 29.16 9.93 21 75160 818 29498528
Meningitis candida 29.04 9.93 10 75171 71 29499275
Chorioretinopathy 29.01 9.93 26 75155 1390 29497956
Sedation 28.35 9.93 5 75176 17400 29481946
Cardiac failure 27.50 9.93 106 75075 79181 29420165
Acute kidney injury 27.46 9.93 492 74689 264775 29234571
Drug hypersensitivity 27.35 9.93 280 74901 68126 29431220
Pneumoretroperitoneum 27.14 9.93 9 75172 56 29499290
Pituitary haemorrhage 26.98 9.93 12 75169 179 29499167
Renal impairment 26.77 9.93 111 75070 81222 29418124
Thermophobia 26.75 9.93 9 75172 59 29499287
Stevens-Johnson syndrome 26.30 9.93 97 75084 16400 29482946
Growth retardation 25.82 9.93 26 75155 1610 29497736
Anaemia 25.36 9.93 359 74822 200592 29298754
Atrial fibrillation 25.26 9.93 161 75020 105485 29393861
Perioral dermatitis 25.04 9.93 10 75171 112 29499234
Soft tissue mass 24.62 9.93 17 75164 619 29498727
Blood pressure increased 24.42 9.93 291 74890 73512 29425834
Candida infection 23.83 9.93 89 75092 15136 29484210
Thyroxine free decreased 23.63 9.93 12 75169 244 29499102
Gastrointestinal haemorrhage 23.49 9.93 113 75068 79420 29419926
Adrenocorticotropic hormone deficiency 23.09 9.93 16 75165 586 29498760
Poor venous access 23.09 9.93 34 75147 3127 29496219
Shared psychotic disorder 22.98 9.93 6 75175 13 29499333
Rash erythematous 22.16 9.93 111 75070 21451 29477895
Cardio-respiratory arrest 22.15 9.93 61 75120 50540 29448806
Oesophageal perforation 22.00 9.93 17 75164 738 29498608
Symptom masked 21.92 9.93 15 75166 538 29498808
Multimorbidity 21.87 9.93 15 75166 540 29498806
Posterior reversible encephalopathy syndrome 21.81 9.93 61 75120 8915 29490431
Periorbital infection 21.41 9.93 9 75172 116 29499230
Cholangitis infective 21.38 9.93 11 75170 230 29499116
Musculoskeletal injury 21.27 9.93 9 75172 118 29499228
Erythema 21.14 9.93 289 74892 75317 29424029
Anal fistula 20.96 9.93 38 75143 4157 29495189
Klebsiella infection 20.96 9.93 53 75128 7296 29492050
Subdural haematoma 20.94 9.93 10 75171 18183 29481163
Hyperbilirubinaemia 20.69 9.93 84 75097 14850 29484496
Optic nerve disorder 20.64 9.93 15 75166 593 29498753
Hypogonadism 20.24 9.93 22 75159 1489 29497857
Blood growth hormone decreased 20.07 9.93 6 75175 25 29499321
Neuroleptic malignant syndrome 19.97 9.93 8 75173 16140 29483206
Feeling cold 19.96 9.93 60 75121 9131 29490215
Intentional product misuse 19.91 9.93 36 75145 34625 29464721
Drug level decreased 19.89 9.93 47 75134 6200 29493146
Abdominal pain 19.83 9.93 467 74714 134890 29364456
Anaphylactic reaction 19.81 9.93 129 75052 27444 29471902
Angina pectoris 19.79 9.93 25 75156 27825 29471521
Neurotoxicity 19.30 9.93 81 75100 14532 29484814
Bronchial haemorrhage 19.08 9.93 15 75166 668 29498678
Pituitary tumour recurrent 19.08 9.93 7 75174 61 29499285
Astrocytoma 18.76 9.93 9 75172 161 29499185
Idiopathic intracranial hypertension 18.67 9.93 14 75167 581 29498765
Vestibular neuronitis 18.56 9.93 9 75172 165 29499181
Superinfection 18.32 9.93 24 75157 1977 29497369
Pouchitis 18.30 9.93 14 75167 599 29498747
Pituitary tumour 18.20 9.93 13 75168 500 29498846
Chills 18.12 9.93 268 74913 71032 29428314
Meningitis tuberculous 18.06 9.93 14 75167 611 29498735
Syncope 17.94 9.93 127 75054 81244 29418102
Cushingoid 17.48 9.93 26 75155 2412 29496934
Gastrointestinal inflammation 17.31 9.93 29 75152 2979 29496367
Anal abscess 17.25 9.93 40 75141 5211 29494135
Gastrointestinal anastomotic leak 17.24 9.93 11 75170 350 29498996
Clostridium difficile infection 17.23 9.93 84 75097 16057 29483289
Blood thyroid stimulating hormone decreased 17.14 9.93 22 75159 1776 29497570
Splenic peliosis 17.09 9.93 5 75176 19 29499327
Blood creatine phosphokinase increased 17.05 9.93 50 75131 40594 29458752
Cryptococcal fungaemia 16.95 9.93 7 75174 86 29499260
Coma 16.94 9.93 48 75133 39402 29459944
Hospitalisation 16.91 9.93 60 75121 45928 29453418
Blood growth hormone increased 16.88 9.93 10 75171 278 29499068
Hallucination 16.66 9.93 58 75123 44654 29454692
Posturing 16.59 9.93 12 75169 471 29498875
Pyrexia 16.49 9.93 891 74290 286731 29212615
Glioma 16.47 9.93 10 75171 291 29499055
Diarrhoea haemorrhagic 16.37 9.93 42 75139 5832 29493514
Secondary adrenocortical insufficiency 16.34 9.93 17 75164 1094 29498252
Aggression 16.19 9.93 42 75139 35499 29463847
Cerebrospinal fluid leakage 16.04 9.93 11 75170 396 29498950
Lacrimal duct neoplasm 15.99 9.93 5 75176 25 29499321
Mantle cell lymphoma stage III 15.99 9.93 5 75176 25 29499321
Anal inflammation 15.90 9.93 10 75171 310 29499036
Body height below normal 15.90 9.93 9 75172 229 29499117
Extrapyramidal disorder 15.82 9.93 4 75177 10827 29488519
Clostridium test positive 15.79 9.93 23 75158 2094 29497252
Gingival disorder 15.75 9.93 18 75163 1288 29498058
Intentional self-injury 15.70 9.93 6 75175 12455 29486891
Anaplastic astrocytoma 15.29 9.93 7 75174 112 29499234
Lactic acidosis 15.16 9.93 34 75147 30213 29469133
Thyroxine decreased 15.13 9.93 7 75174 115 29499231
Glioblastoma multiforme 15.01 9.93 13 75168 664 29498682
Dermatitis diaper 14.94 9.93 9 75172 258 29499088
Renal failure 14.89 9.93 212 74969 118387 29380959
Electrocardiogram QT prolonged 14.76 9.93 45 75136 36092 29463254
Anal fissure 14.75 9.93 26 75155 2782 29496564
Feeling hot 14.71 9.93 78 75103 15410 29483936
Cryptococcal meningoencephalitis 14.70 9.93 7 75174 123 29499223
Otitis media acute 14.64 9.93 11 75170 458 29498888
Lichenification 14.61 9.93 9 75172 269 29499077
Congenital cardiovascular anomaly 14.59 9.93 8 75173 191 29499155
Functional gastrointestinal disorder 14.57 9.93 22 75159 2068 29497278
Blood pressure diastolic decreased 14.46 9.93 45 75136 6977 29492369
Respiratory disorder 14.44 9.93 83 75098 16900 29482446
Addison's disease 14.40 9.93 4 75177 12 29499334
Toxic epidermal necrolysis 14.32 9.93 87 75094 18066 29481280
Nervous system disorder 14.28 9.93 67 75114 12607 29486739
Eczema herpeticum 14.21 9.93 7 75174 133 29499213
Perirectal abscess 14.09 9.93 18 75163 1447 29497899
Sepsis 14.06 9.93 468 74713 142214 29357132
Accidental exposure to product 13.85 9.93 5 75176 10748 29488598
Product quality issue 13.84 9.93 12 75169 15883 29483463
Short-bowel syndrome 13.81 9.93 8 75173 213 29499133
Mean cell volume decreased 13.73 9.93 16 75165 1169 29498177
Prothrombin level abnormal 13.70 9.93 6 75175 86 29499260
Oxygen saturation abnormal 13.66 9.93 16 75165 1176 29498170
Trichosporon infection 13.61 9.93 12 75169 628 29498718
Transient ischaemic attack 13.51 9.93 24 75157 23246 29476100
Coronary artery disease 13.50 9.93 62 75119 44128 29455218
Cardiac failure congestive 13.46 9.93 127 75054 76454 29422892
Hyperkalaemia 13.44 9.93 96 75085 61296 29438050
Perineal pain 13.40 9.93 13 75168 769 29498577
Accidental overdose 13.34 9.93 15 75166 17578 29481768
Respiratory depression 13.32 9.93 9 75172 13514 29485832
Transient aphasia 13.22 9.93 6 75175 94 29499252
Malignant neoplasm progression 13.19 9.93 122 75059 73737 29425609
Pallor 13.10 9.93 95 75086 20929 29478417
Rectal abscess 12.97 9.93 14 75167 940 29498406
Weight increased 12.94 9.93 270 74911 76397 29422949
Strongyloidiasis 12.92 9.93 22 75159 2290 29497056
Administration site bruise 12.86 9.93 3 75178 3 29499343
General physical health deterioration 12.86 9.93 184 74997 102673 29396673
Shunt malfunction 12.85 9.93 7 75174 165 29499181
Contraindicated product prescribed 12.76 9.93 9 75172 339 29499007
Gram stain positive 12.73 9.93 6 75175 103 29499243
Phaeochromocytoma crisis 12.44 9.93 5 75176 57 29499289
Morganella infection 12.42 9.93 10 75171 461 29498885
Groin infection 12.41 9.93 7 75174 177 29499169
Kounis syndrome 12.40 9.93 19 75162 1810 29497536
Pharyngitis bacterial 12.29 9.93 5 75176 59 29499287
Blood luteinising hormone decreased 12.28 9.93 6 75175 112 29499234
Hypernatraemia 12.25 9.93 44 75137 7342 29492004
Immunosuppressant drug level increased 12.19 9.93 33 75148 4732 29494614
Blood creatinine increased 12.18 9.93 148 75033 84954 29414392
Platelet count decreased 12.13 9.93 190 74991 104482 29394864
Epileptic encephalopathy 12.13 9.93 6 75175 115 29499231
Hydrocephalus 12.12 9.93 31 75150 4296 29495050
Blood culture positive 12.01 9.93 32 75149 4545 29494801
Pharyngitis streptococcal 12.01 9.93 20 75161 2044 29497302
Hypothalamo-pituitary disorder 12.00 9.93 12 75169 737 29498609
Sitting disability 11.90 9.93 6 75175 120 29499226
Tracheobronchitis 11.83 9.93 13 75168 891 29498455
Urticaria 11.82 9.93 200 74981 54460 29444886
Body temperature decreased 11.74 9.93 56 75125 10608 29488738
Adenoidal hypertrophy 11.68 9.93 6 75175 125 29499221
Blood corticotrophin increased 11.65 9.93 5 75176 68 29499278
Congenital adrenal gland hypoplasia 11.65 9.93 3 75178 6 29499340
Renal disorder 11.65 9.93 25 75156 22570 29476776
Proctitis 11.62 9.93 20 75161 2099 29497247
Gastroenteritis 11.61 9.93 63 75118 12553 29486793
Arm amputation 11.55 9.93 6 75175 128 29499218
Wrong technique in product usage process 11.55 9.93 41 75140 31387 29467959
Gonadotrophin deficiency 11.43 9.93 4 75177 30 29499316
Hyperamylasaemia 11.43 9.93 10 75171 518 29498828
Cerebral infarction 11.36 9.93 29 75152 24646 29474700
Diplegia 11.31 9.93 13 75168 936 29498410
Antibody test abnormal 11.27 9.93 6 75175 135 29499211
Chronic kidney disease 11.18 9.93 51 75130 36365 29462981
Serotonin syndrome 11.16 9.93 17 75164 17495 29481851
Febrile convulsion 11.15 9.93 10 75171 535 29498811
Myelitis transverse 11.13 9.93 13 75168 952 29498394
Cortisol abnormal 11.10 9.93 4 75177 33 29499313
Eye pruritus 11.08 9.93 30 75151 4302 29495044
Bradycardia 11.04 9.93 110 75071 65519 29433827
Leptotrichia infection 11.04 9.93 5 75176 78 29499268
Suicidal ideation 11.03 9.93 48 75133 34668 29464678
Tooth injury 10.97 9.93 12 75169 818 29498528
Hepatic function abnormal 10.89 9.93 57 75124 39202 29460144
Product dose omission issue 10.82 9.93 176 75005 96207 29403139
Transplant failure 10.78 9.93 23 75158 2833 29496513
Eczema 10.74 9.93 66 75115 13760 29485586
Bone cyst 10.72 9.93 10 75171 563 29498783
Intestinal stenosis 10.59 9.93 18 75163 1870 29497476
Melaena 10.59 9.93 42 75139 31134 29468212
Paraesthesia 10.56 9.93 194 74987 53651 29445695
Unmasking of previously unidentified disease 10.52 9.93 11 75170 712 29498634
Proteus infection 10.45 9.93 12 75169 863 29498483
Tendonitis 10.41 9.93 44 75137 7917 29491429
Pulmonary arterial hypertension 10.41 9.93 3 75178 7446 29491900
Peptic ulcer haemorrhage 10.40 9.93 9 75172 459 29498887
Gastric ulcer perforation 10.40 9.93 12 75169 868 29498478
Vomiting projectile 10.33 9.93 10 75171 590 29498756
Drug-induced liver injury 10.32 9.93 25 75156 21630 29477716
Abdominal abscess 10.31 9.93 27 75154 3797 29495549
Eosinophilia 10.24 9.93 26 75155 22135 29477211
Multiple organ dysfunction syndrome 10.24 9.93 221 74960 62895 29436451
Hepatic cirrhosis 10.22 9.93 13 75168 14431 29484915
Botulism 10.22 9.93 6 75175 164 29499182
Rhabdomyolysis 10.19 9.93 102 75079 60706 29438640
Psychotic disorder 10.10 9.93 23 75158 20331 29479015
Somnolence 10.08 9.93 173 75008 93782 29405564
Depressed level of consciousness 10.04 9.93 54 75127 36888 29462458
Superior sagittal sinus thrombosis 10.01 9.93 7 75174 260 29499086
Inflammatory marker increased 9.99 9.93 26 75155 3641 29495705
Delirium 9.94 9.93 59 75122 39338 29460008

FDA Adverse Event Reporting System (Geriatric)

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
Completed suicide 544.59 9.42 20 181806 224394 64092512
Infusion related reaction 453.09 9.42 1248 180578 163219 64153687
Toxicity to various agents 385.63 9.42 278 181548 363235 63953671
Adrenocortical insufficiency acute 361.48 9.42 166 181660 2399 64314507
Intentional product use issue 344.21 9.42 802 181024 94562 64222344
Drug abuse 313.56 9.42 14 181812 132360 64184546
Adrenal insufficiency 292.99 9.42 339 181487 22148 64294758
Anti-cyclic citrullinated peptide antibody positive 290.44 9.42 510 181316 49052 64267854
Pericarditis 272.22 9.42 567 181259 61949 64254957
Wound 269.19 9.42 637 181189 75840 64241066
Blood pressure fluctuation 268.72 9.42 506 181320 51365 64265541
Glossodynia 251.00 9.42 560 181266 64136 64252770
Pemphigus 242.92 9.42 532 181294 60169 64256737
Systemic lupus erythematosus 231.59 9.42 607 181219 77005 64239901
Hand deformity 225.41 9.42 527 181299 62244 64254662
Discomfort 223.66 9.42 615 181211 80263 64236643
Rheumatoid factor positive 205.29 9.42 360 181466 34578 64282328
Death 198.69 9.42 697 181129 482008 63834898
Craniopharyngioma 197.37 9.42 64 181762 325 64316581
Duodenal ulcer perforation 196.00 9.42 351 181475 34274 64282632
Colitis ulcerative 189.94 9.42 277 181549 22751 64294155
Helicobacter infection 189.76 9.42 367 181459 37995 64278911
Product use issue 179.59 9.42 875 180951 150840 64166066
Off label use 175.62 9.42 2627 179199 630179 63686727
Steroid withdrawal syndrome 168.81 9.42 65 181761 585 64316321
Inappropriate schedule of product administration 156.04 9.42 593 181233 91693 64225213
Synovitis 154.78 9.42 621 181205 98469 64218437
Drug interaction 154.12 9.42 515 181311 361568 63955338
Intentional overdose 153.40 9.42 33 181793 89911 64226995
Arthropathy 149.86 9.42 707 181119 120260 64196646
Overdose 136.44 9.42 149 181677 159417 64157489
Hypersensitivity 133.63 9.42 980 180846 195472 64121434
Alopecia 130.03 9.42 856 180970 164834 64152072
Condition aggravated 128.68 9.42 1609 180217 370817 63946089
Blister 121.32 9.42 501 181325 80466 64236440
Secondary immunodeficiency 119.89 9.42 82 181744 2642 64314264
Fall 118.37 9.42 690 181136 416136 63900770
Drug hypersensitivity 117.11 9.42 1103 180723 236712 64080194
Swelling 112.80 9.42 806 181020 159412 64157494
Abdominal discomfort 105.95 9.42 877 180949 181445 64135461
Irritable bowel syndrome 105.08 9.42 286 181540 37083 64279823
Febrile bone marrow aplasia 104.07 9.42 143 181683 11112 64305794
Pituitary tumour benign 100.86 9.42 69 181757 2224 64314682
Maternal exposure during pregnancy 99.39 9.42 533 181293 95351 64221555
Frequent bowel movements 95.29 9.42 179 181647 18126 64298780
Heart rate irregular 94.94 9.42 227 181599 27186 64289720
Hepatic enzyme increased 92.19 9.42 655 181171 129288 64187618
Drug level below therapeutic 87.37 9.42 106 181720 7278 64309628
Leukoencephalopathy 87.35 9.42 103 181723 6864 64310042
Folliculitis 86.37 9.42 232 181594 29845 64287061
Febrile neutropenia 86.23 9.42 858 180968 186799 64130107
Hypopituitarism 84.77 9.42 66 181760 2607 64314299
Acute kidney injury 84.15 9.42 835 180991 448405 63868501
Interstitial lung disease 83.80 9.42 91 181735 97641 64219265
Muscle injury 83.16 9.42 211 181615 26226 64290680
Suicide attempt 80.88 9.42 50 181776 70957 64245949
Rash 78.92 9.42 1768 180058 456781 63860125
Sleep disorder due to general medical condition, insomnia type 78.85 9.42 206 181620 26064 64290842
Faecal calprotectin increased 76.61 9.42 71 181755 3569 64313337
Diabetes insipidus 76.06 9.42 78 181748 4443 64312463
Body temperature fluctuation 72.66 9.42 66 181760 3232 64313674
Hypofibrinogenaemia 70.02 9.42 50 181776 1728 64315178
Anaemia 69.97 9.42 706 181120 377974 63938932
Neoplasm recurrence 69.32 9.42 68 181758 3671 64313235
Mycobacterium chelonae infection 68.28 9.42 53 181773 2084 64314822
Myocardial infarction 68.27 9.42 239 181587 165582 64151324
Secondary adrenocortical insufficiency 66.03 9.42 54 181772 2291 64314615
Sedation 65.24 9.42 18 181808 41444 64275462
Poor venous access 64.10 9.42 121 181705 12296 64304610
Cortisol decreased 63.39 9.42 46 181780 1631 64315275
Drug intolerance 61.69 9.42 805 181021 187187 64129719
Hip arthroplasty 61.61 9.42 165 181661 21186 64295720
Therapeutic response shortened 61.29 9.42 106 181720 10064 64306842
Weight increased 60.46 9.42 890 180936 212458 64104448
Bacterial infection 60.45 9.42 181 181645 24769 64292137
Coma 60.33 9.42 96 181730 87519 64229387
Aplastic anaemia 60.25 9.42 126 181700 13794 64303112
Rheumatic fever 60.16 9.42 100 181726 9194 64307712
Cardio-respiratory arrest 57.74 9.42 119 181707 98274 64218632
Syncope 56.65 9.42 240 181586 157395 64159511
Drug specific antibody present 56.18 9.42 71 181755 5083 64311823
Adrenal suppression 56.17 9.42 39 181787 1288 64315618
Pseudostroke 55.94 9.42 16 181810 48 64316858
Intentional product misuse 55.90 9.42 73 181753 72222 64244684
Cardiac failure 55.01 9.42 190 181636 132183 64184723
Heart rate decreased 54.27 9.42 302 181524 54765 64262141
Fistula 54.01 9.42 98 181728 9663 64307243
Gastrointestinal haemorrhage 53.58 9.42 192 181634 132120 64184786
Atrial fibrillation 52.93 9.42 275 181551 170814 64146092
Perioral dermatitis 52.54 9.42 22 181804 251 64316655
Renal impairment 51.37 9.42 201 181625 134816 64182090
Cardiac failure congestive 51.23 9.42 192 181634 130388 64186518
Human bocavirus infection 50.75 9.42 27 181799 544 64316362
Hypophysitis 48.62 9.42 55 181771 3504 64313402
Respiratory arrest 48.05 9.42 47 181779 52938 64263968
Swollen joint count increased 47.46 9.42 81 181745 7608 64309298
Meningitis candida 47.13 9.42 17 181809 125 64316781
Septic shock 46.90 9.42 479 181347 104958 64211948
Serotonin syndrome 45.65 9.42 27 181799 39255 64277651
Parainfluenzae virus infection 44.96 9.42 61 181765 4682 64312224
Lactic acidosis 44.48 9.42 65 181761 61345 64255561
Insulin-like growth factor increased 44.34 9.42 37 181789 1615 64315291
Product dose omission issue 44.31 9.42 344 181482 194403 64122503
Pseudomonal sepsis 43.79 9.42 63 181763 5109 64311797
Arthralgia 43.26 9.42 1588 180238 440672 63876234
Urticaria thermal 43.21 9.42 17 181809 163 64316743
Intentional self-injury 43.16 9.42 14 181812 29030 64287876
Anal fissure 43.07 9.42 61 181765 4875 64312031
Insulin-like growth factor decreased 42.98 9.42 24 181802 534 64316372
Blood creatinine increased 42.69 9.42 217 181609 135565 64181341
Device expulsion 42.20 9.42 5 181821 21131 64295775
Clostridium difficile colitis 41.97 9.42 170 181656 27053 64289853
Electrocardiogram QT prolonged 41.00 9.42 103 181723 79345 64237561
Pruritus 40.46 9.42 1160 180666 311240 64005666
Joint swelling 40.30 9.42 841 180985 214541 64102365
Hypothalamo-pituitary disorder 40.29 9.42 29 181797 1015 64315891
Bradycardia 40.03 9.42 184 181642 118035 64198871
Colitis 39.98 9.42 293 181533 58381 64258525
Neuroleptic malignant syndrome 39.05 9.42 11 181815 24985 64291921
Contraindicated product administered 38.87 9.42 470 181356 107359 64209547
Knee arthroplasty 38.80 9.42 165 181661 26834 64290072
Drug level decreased 38.48 9.42 94 181732 11409 64305497
Blood creatine phosphokinase increased 37.69 9.42 67 181759 58491 64258415
Mucosal inflammation 37.34 9.42 303 181523 62281 64254625
Pituitary tumour recurrent 36.85 9.42 14 181812 121 64316785
Eczema herpeticum 36.77 9.42 16 181810 202 64316704
Tendon pain 36.65 9.42 56 181770 4792 64312114
Depressed level of consciousness 36.51 9.42 113 181713 81323 64235583
Anal fistula 36.00 9.42 58 181768 5195 64311711
Human herpesvirus 6 infection 35.53 9.42 54 181772 4600 64312306
Pituitary haemorrhage 34.86 9.42 17 181809 283 64316623
Live birth 34.79 9.42 89 181737 11115 64305791
Lower respiratory tract infection 34.36 9.42 413 181413 94201 64222705
Pneumoretroperitoneum 33.90 9.42 12 181814 83 64316823
Hepatic function abnormal 33.48 9.42 83 181743 64230 64252676
Shared psychotic disorder 33.37 9.42 10 181816 37 64316869
Anal abscess 32.54 9.42 68 181758 7440 64309466
Platelet count decreased 32.44 9.42 309 181517 167402 64149504
Accidental exposure to product 32.25 9.42 17 181809 26347 64290559
Injection site reaction 32.24 9.42 51 181775 46613 64270293
Melaena 32.06 9.42 64 181762 53484 64263422
Wrong technique in product usage process 31.42 9.42 87 181739 64887 64252019
Malignant neoplasm progression 31.31 9.42 188 181638 112683 64204223
Full blood count abnormal 31.14 9.42 23 181803 29734 64287172
Impaired healing 30.95 9.42 283 181543 60190 64256716
Epidural lipomatosis 30.77 9.42 23 181803 854 64316052
Thymus hypoplasia 30.71 9.42 19 181807 514 64316392
Maternal exposure timing unspecified 30.64 9.42 38 181788 2669 64314237
Cerebrovascular accident 30.37 9.42 245 181581 137338 64179568
Cognitive disorder 30.34 9.42 69 181757 55018 64261888
Injury 30.18 9.42 265 181561 55727 64261179
Suicidal ideation 30.07 9.42 92 181734 66450 64250456
Pneumonia 30.04 9.42 1281 180545 558295 63758611
Candida infection 28.78 9.42 169 181657 31250 64285656
Injection site erythema 28.48 9.42 103 181723 70697 64246209
Norovirus test positive 28.36 9.42 17 181809 434 64316472
Hyperadrenocorticism 28.25 9.42 15 181811 301 64316605
Urticaria 28.12 9.42 577 181249 146740 64170166
Extrapyramidal disorder 28.06 9.42 10 181816 19542 64297364
Leukopenia 27.89 9.42 169 181657 101073 64215833
Stomatitis 27.85 9.42 449 181377 109156 64207750
Disease progression 27.84 9.42 260 181566 141420 64175486
Haemoglobin decreased 27.72 9.42 385 181441 194678 64122228
Flushing 27.55 9.42 341 181485 78307 64238599
Gastrointestinal disorder 27.27 9.42 379 181447 89330 64227576
Transient ischaemic attack 27.15 9.42 52 181774 44130 64272776
Lymphoid tissue hypoplasia 27.02 9.42 17 181809 474 64316432
Injection site swelling 26.90 9.42 47 181779 41306 64275600
Accidental overdose 26.86 9.42 33 181793 33524 64283382
Hypothalamic pituitary adrenal axis suppression 26.41 9.42 14 181812 280 64316626
Myelopathy 26.04 9.42 43 181783 3931 64312975
Epiphysiolysis 25.87 9.42 10 181816 91 64316815
Diarrhoea haemorrhagic 25.84 9.42 80 181746 11147 64305759
Thermophobia 25.83 9.42 9 181817 59 64316847
Pneumatosis intestinalis 25.81 9.42 50 181776 5179 64311727
Chronic obstructive pulmonary disease 25.61 9.42 108 181718 70940 64245966
Exposure during pregnancy 25.60 9.42 333 181493 77342 64239564
Natural killer-cell leukaemia 25.59 9.42 10 181816 94 64316812
Eczema 25.40 9.42 157 181669 29563 64287343
Blood pressure increased 24.92 9.42 650 181176 171902 64145004
Astrocytoma 24.76 9.42 12 181814 197 64316709
Perfume sensitivity 24.74 9.42 18 181808 641 64316265
Hyperkalaemia 24.72 9.42 175 181651 100954 64215952
Nausea 24.32 9.42 1897 179929 783903 63533003
Somnolence 24.16 9.42 416 181410 203229 64113677
Tendon rupture 24.12 9.42 76 181750 10691 64306215
Ill-defined disorder 24.00 9.42 209 181617 43843 64273063
Musculoskeletal injury 23.82 9.42 11 181815 161 64316745
Hypernatraemia 23.69 9.42 82 181744 12107 64304799
Dry skin 23.49 9.42 234 181592 50927 64265979
Respiratory depression 23.41 9.42 19 181807 23424 64293482
Type 2 diabetes mellitus 23.24 9.42 170 181656 33850 64283056
Viral infection 23.22 9.42 178 181648 35962 64280944
Parkinsonism 23.06 9.42 6 181820 14367 64302539
Growth retardation 22.83 9.42 25 181801 1536 64315370
Cerebrospinal fluid leakage 22.73 9.42 23 181803 1289 64315617
Cardiac disorder 22.58 9.42 81 181745 55735 64261171
Tendon disorder 22.53 9.42 53 181773 6279 64310627
Abscess bacterial 22.43 9.42 18 181808 743 64316163
Pulmonary arterial hypertension 22.43 9.42 23 181803 25344 64291562
Rhinovirus infection 22.42 9.42 52 181774 6104 64310802
Normal tension glaucoma 22.28 9.42 8 181818 58 64316848
Subdural haematoma 22.02 9.42 28 181798 28026 64288880
Female genital tract fistula 21.95 9.42 32 181794 2626 64314280
Nasopharyngitis 21.85 9.42 715 181111 195358 64121548
Cystitis bacterial 21.68 9.42 14 181812 409 64316497
Enterobacter infection 21.59 9.42 38 181788 3658 64313248
Schizophrenia 21.43 9.42 3 181823 11165 64305741
Hypogonadism 21.42 9.42 20 181806 1015 64315891
Allergy test positive 21.29 9.42 14 181812 422 64316484
Hepatotoxicity 21.25 9.42 51 181775 39911 64276995
White blood cell count decreased 21.20 9.42 315 181511 157522 64159384
Abdominal pain 20.95 9.42 1079 180747 311296 64005610
Therapeutic product effect decreased 20.77 9.42 448 181378 114903 64202003
Symptom masked 20.67 9.42 21 181805 1183 64315723
Drug level above therapeutic 20.59 9.42 54 181772 6847 64310059
Adrenocorticotropic hormone deficiency 20.51 9.42 18 181808 842 64316064
Blood corticotrophin decreased 20.49 9.42 13 181813 368 64316538
Rhabdomyolysis 20.39 9.42 163 181663 91563 64225343
Renal failure 20.33 9.42 375 181451 181313 64135593
Hyperemesis gravidarum 20.24 9.42 13 181813 376 64316530
Cardiac arrest 20.17 9.42 309 181517 153755 64163151
Hospitalisation 19.95 9.42 127 181699 75080 64241826
Oxygen saturation abnormal 19.94 9.42 36 181790 3535 64313371
Balance disorder 19.66 9.42 147 181679 83779 64233127
Chronic sinusitis 19.56 9.42 50 181776 6242 64310664
Gastroenteritis norovirus 19.51 9.42 31 181795 2744 64314162
Proctalgia 19.42 9.42 56 181770 7503 64309403
Oedema peripheral 19.41 9.42 448 181378 209869 64107037
Airway peak pressure increased 19.38 9.42 12 181814 325 64316581
Coronary artery disease 19.32 9.42 96 181730 60337 64256569
Loss of consciousness 19.27 9.42 298 181528 148067 64168839
Hallucination 19.27 9.42 123 181703 72665 64244241
Pouchitis 19.16 9.42 17 181809 807 64316099
Poisoning deliberate 19.11 9.42 7 181819 13451 64303455
Breast cancer 19.07 9.42 33 181793 29115 64287791
Blood corticotrophin increased 19.00 9.42 9 181817 140 64316766
Hepatic cirrhosis 18.88 9.42 28 181798 26270 64290636
Product prescribing error 18.76 9.42 45 181781 35224 64281682
Osteonecrosis of jaw 18.76 9.42 54 181772 39771 64277135
Fibromyalgia 18.68 9.42 168 181658 35563 64281343
Cerebral vasoconstriction 18.62 9.42 20 181806 1202 64315704
Mastocytosis 18.57 9.42 13 181813 435 64316471
Body temperature decreased 18.54 9.42 131 181695 25797 64291109
Injection site pain 18.38 9.42 213 181613 111195 64205711
Product quality issue 18.37 9.42 35 181791 29764 64287142
Bronchopulmonary aspergillosis 18.35 9.42 104 181722 18981 64297925
Fluid retention 18.31 9.42 96 181730 59510 64257396
Coronavirus infection 18.30 9.42 45 181781 5485 64311421
Haematuria 18.23 9.42 98 181728 60373 64256533
Cerebral haemorrhage 18.20 9.42 78 181748 51012 64265894
Morganella infection 18.10 9.42 18 181808 988 64315918
Pituitary infarction 18.08 9.42 7 181819 64 64316842
Unevaluable event 18.04 9.42 77 181749 50412 64266494
Rash erythematous 17.96 9.42 213 181613 48420 64268486
Chronic kidney disease 17.95 9.42 93 181733 57826 64259080
Glioblastoma multiforme 17.92 9.42 19 181807 1125 64315781
Thrombocytopenia 17.88 9.42 487 181339 223314 64093592
Acute myocardial infarction 17.85 9.42 119 181707 69599 64247307
Soft tissue mass 17.73 9.42 17 181809 892 64316014
Therapy cessation 17.64 9.42 41 181785 32448 64284458
Cerebral microangiopathy 17.61 9.42 10 181816 230 64316676
Aggression 17.46 9.42 69 181757 46163 64270743
Asthenia 17.45 9.42 1008 180818 427036 63889870
Drug-induced liver injury 17.43 9.42 72 181754 47571 64269335
Agitation 17.42 9.42 162 181664 88205 64228701
Salpingo-oophorectomy unilateral 17.39 9.42 13 181813 483 64316423
Incorrect dose administered 17.37 9.42 254 181572 60511 64256395
Labelled drug-drug interaction medication error 17.34 9.42 22 181804 22040 64294866
Metabolic acidosis 17.24 9.42 123 181703 70835 64246071
Angina pectoris 17.21 9.42 67 181759 45014 64271892
Adrenal disorder 17.16 9.42 22 181804 1598 64315308
Mydriasis 17.13 9.42 11 181815 15301 64301605
Therapeutic reaction time decreased 17.04 9.42 24 181802 1908 64314998
Orthostatic hypotension 16.87 9.42 71 181755 46667 64270239
Unmasking of previously unidentified disease 16.87 9.42 22 181804 1625 64315281
Skin weeping 16.80 9.42 14 181812 610 64316296
Deep vein thrombosis postoperative 16.74 9.42 20 181806 1351 64315555
Natural killer cell count decreased 16.65 9.42 6 181820 44 64316862
Peptic ulcer haemorrhage 16.60 9.42 16 181810 845 64316061
Drug withdrawal syndrome 16.58 9.42 40 181786 31251 64285655
Splenic peliosis 16.58 9.42 5 181821 19 64316887
Red blood cell sedimentation rate abnormal 16.55 9.42 13 181813 16293 64300613
Neutropenia 16.51 9.42 532 181294 239092 64077814
Vertigo 16.51 9.42 98 181728 58913 64257993
Liver function test abnormal 16.43 9.42 99 181727 59302 64257604
Glioma 16.40 9.42 13 181813 527 64316379
Delusion 16.31 9.42 16 181810 17998 64298908
Viraemia 16.18 9.42 26 181800 2323 64314583
Hypercalcaemia 15.99 9.42 41 181785 31375 64285531
Eosinophilic oesophagitis 15.91 9.42 12 181814 452 64316454
Anaplastic astrocytoma 15.89 9.42 8 181818 143 64316763
Dermatitis diaper 15.86 9.42 10 181816 280 64316626
Strongyloidiasis 15.81 9.42 30 181796 3060 64313846
Oesophageal perforation 15.80 9.42 17 181809 1024 64315882
Hypertriglyceridaemia 15.73 9.42 68 181758 11137 64305769
Neutropenic sepsis 15.73 9.42 116 181710 23156 64293750
Diplegia 15.70 9.42 21 181805 1590 64315316
Pyoderma gangrenosum 15.62 9.42 30 181796 3088 64313818
Herpes simplex 15.61 9.42 65 181761 10471 64306435
Drug resistance 15.52 9.42 49 181777 35053 64281853
Metastases to bone 15.42 9.42 21 181805 20414 64296492
Toxic skin eruption 15.39 9.42 19 181807 19265 64297641
Diffuse large B-cell lymphoma 15.39 9.42 5 181821 10356 64306550
Enteritis 15.23 9.42 71 181755 12006 64304900
Tubulointerstitial nephritis 15.23 9.42 41 181785 30868 64286038
Therapeutic product effect incomplete 15.14 9.42 203 181623 103279 64213627
Haematochezia 15.06 9.42 267 181559 66106 64250800
Tuberculosis gastrointestinal 15.03 9.42 12 181814 492 64316414
Lichen planus 15 9.42 25 181801 2303 64314603
Pituitary tumour 14.95 9.42 17 181809 1089 64315817
Angina unstable 14.87 9.42 13 181813 15454 64301452
Myelodysplastic syndrome 14.82 9.42 35 181791 27544 64289362
International normalised ratio increased 14.82 9.42 147 181679 79020 64237886
Blood growth hormone increased 14.80 9.42 13 181813 609 64316297
Excessive eye blinking 14.76 9.42 18 181808 1242 64315664
Dyskinesia 14.74 9.42 59 181767 39329 64277577
Mucous stools 14.60 9.42 30 181796 3243 64313663
Blood cholesterol increased 14.60 9.42 210 181616 49856 64267050
Multimorbidity 14.44 9.42 16 181810 996 64315910
Cerebral infarction 14.42 9.42 63 181763 40981 64275925
Blood pressure diastolic decreased 14.41 9.42 110 181716 22191 64294715
Cortisol abnormal 14.29 9.42 6 181820 69 64316837
Tendonitis 14.22 9.42 102 181724 20180 64296726
Pulmonary hypertension 14.09 9.42 68 181758 43071 64273835
Adjustment disorder with depressed mood 14.02 9.42 25 181801 2432 64314474
Medication error 13.97 9.42 83 181743 49883 64267023
Blood potassium increased 13.94 9.42 33 181793 25947 64290959
Multiple sclerosis relapse 13.93 9.42 64 181762 41071 64275835
Excessive skin 13.91 9.42 7 181819 125 64316781
Skin fragility 13.85 9.42 14 181812 784 64316122
Cholangitis infective 13.84 9.42 11 181815 448 64316458
Kounis syndrome 13.82 9.42 28 181798 2997 64313909
Intestinal stenosis 13.80 9.42 29 181797 3185 64313721
Defaecation urgency 13.77 9.42 33 181793 3956 64312950
Enthesopathy 13.71 9.42 5 181821 9633 64307273
Clostridium difficile infection 13.62 9.42 159 181667 36004 64280902
Pulmonary oedema 13.53 9.42 149 181677 78525 64238381
Cushing's syndrome 13.51 9.42 15 181811 936 64315970
Anti-cyclic citrullinated peptide antibody 13.44 9.42 18 181808 1364 64315542
Optic glioma 13.39 9.42 5 181821 41 64316865
Chorioretinopathy 13.37 9.42 23 181803 2174 64314732
Cryptococcal meningoencephalitis 13.35 9.42 8 181818 204 64316702
Jaundice 13.34 9.42 81 181745 48431 64268475
Wheezing 13.26 9.42 309 181517 80270 64236636
Faecal calprotectin abnormal 13.25 9.42 7 181819 139 64316767
Adenoidal hypertrophy 13.25 9.42 7 181819 139 64316767
Rectal abscess 13.23 9.42 19 181807 1538 64315368
Thyroxine free decreased 13.21 9.42 14 181812 829 64316077
B-lymphocyte count increased 13.20 9.42 7 181819 140 64316766
Lip dry 13.19 9.42 37 181789 4881 64312025
Pyrexia 13.18 9.42 1782 180044 556862 63760044
Cardiac failure acute 13.15 9.42 16 181810 16328 64300578
Muscle rigidity 13.14 9.42 18 181808 17455 64299451
Epistaxis 13.12 9.42 196 181630 97935 64218971
Clostridium test positive 13.10 9.42 33 181793 4082 64312824
Stevens-Johnson syndrome 13.09 9.42 151 181675 34098 64282808
Antithrombin III 13.05 9.42 6 181820 87 64316819
Product storage error 13.04 9.42 11 181815 13307 64303599
Rheumatoid arthritis 12.99 9.42 358 181468 163936 64152970
Aborted pregnancy 12.99 9.42 5 181821 45 64316861
Facet joint syndrome 12.98 9.42 21 181805 1888 64315018
Uterine cyst 12.94 9.42 9 181817 298 64316608
Underdose 12.93 9.42 34 181792 25795 64291111
Palmar-plantar erythrodysaesthesia syndrome 12.91 9.42 40 181786 28779 64288127
Creatinine renal clearance decreased 12.83 9.42 13 181813 14408 64302498
Sitting disability 12.81 9.42 7 181819 149 64316757
Germ cell cancer 12.77 9.42 7 181819 150 64316756
Abdominal abscess 12.77 9.42 43 181783 6261 64310645
Posturing 12.75 9.42 15 181811 997 64315909
Arrhythmia 12.75 9.42 92 181734 52852 64264054
Chills 12.67 9.42 490 181336 136774 64180132
Erythema nodosum 12.63 9.42 32 181794 3972 64312934
Asphyxia 12.63 9.42 57 181769 9509 64307397
Myelitis transverse 12.63 9.42 19 181807 1604 64315302
Shunt malfunction 12.62 9.42 8 181818 226 64316680
Renal disorder 12.59 9.42 54 181772 35311 64281595
Skin exfoliation 12.59 9.42 187 181639 44698 64272208
Catatonia 12.58 9.42 3 181823 7617 64309289
Hyperamylasaemia 12.57 9.42 14 181812 877 64316029
Dysarthria 12.55 9.42 107 181719 59299 64257607
Dizziness 12.54 9.42 1043 180783 429120 63887786
Lung neoplasm malignant 12.52 9.42 26 181800 21422 64295484
Cryptococcal fungaemia 12.37 9.42 7 181819 160 64316746
PO2 decreased 12.26 9.42 25 181801 2688 64314218
PCO2 increased 12.24 9.42 19 181807 1648 64315258
Myelosuppression 12.21 9.42 31 181795 23799 64293107
Neutrophil count decreased 12.19 9.42 149 181677 77047 64239859
Anorectal ulcer 12.18 9.42 5 181821 54 64316852
Non-consummation 12.18 9.42 5 181821 54 64316852
Bladder cancer 12.12 9.42 8 181818 10966 64305940
Mucosal hyperaemia 12.10 9.42 5 181821 55 64316851
Erythema 12.08 9.42 644 181182 186426 64130480
Inflammatory bowel disease 12.03 9.42 34 181792 4504 64312402
Oropharyngeal pain 12.03 9.42 332 181494 88535 64228371
Aspartate aminotransferase increased 11.95 9.42 252 181574 119536 64197370
Conus medullaris syndrome 11.92 9.42 4 181822 23 64316883
Klebsiella infection 11.88 9.42 71 181755 13210 64303696
Aspergillus infection 11.85 9.42 83 181743 16296 64300610
Upper gastrointestinal haemorrhage 11.81 9.42 55 181771 35165 64281741
Contusion 11.77 9.42 412 181414 113553 64203353
Dyspnoea exertional 11.76 9.42 142 181684 73588 64243318
Atrial flutter 11.74 9.42 23 181803 19357 64297549
Rheumatoid nodule 11.73 9.42 11 181815 12640 64304266
Serum sickness 11.68 9.42 27 181799 3162 64313744
Anal inflammation 11.67 9.42 10 181816 453 64316453
Loss of employment 11.65 9.42 20 181806 1887 64315019
Infection 11.65 9.42 635 181191 184245 64132661
Status asthmaticus 11.62 9.42 14 181812 954 64315952
Lichenification 11.61 9.42 12 181814 690 64316216
Pharyngeal paraesthesia 11.58 9.42 20 181806 1897 64315009
Thyrotoxic crisis 11.58 9.42 15 181811 1101 64315805
Posterior reversible encephalopathy syndrome 11.54 9.42 107 181719 22839 64294067
Abdominal compartment syndrome 11.52 9.42 17 181809 1411 64315495
Treatment failure 11.50 9.42 420 181406 116396 64200510
Neurotoxicity 11.47 9.42 123 181703 27281 64289625
Gastrointestinal inflammation 11.46 9.42 41 181785 6154 64310752
Nasal polyps 11.45 9.42 29 181797 3600 64313306
Enterobacter bacteraemia 11.44 9.42 11 181815 579 64316327
Pseudomonas infection 11.44 9.42 88 181738 17795 64299111
Proteinuria 11.37 9.42 40 181786 27683 64289223
Cushingoid 11.34 9.42 47 181779 7556 64309350
Cytomegalovirus chorioretinitis 11.30 9.42 35 181791 4877 64312029
Pain 11.30 9.42 1751 180075 551760 63765146
Skin wrinkling 11.27 9.42 14 181812 985 64315921
Intestinal resection 11.27 9.42 26 181800 3042 64313864
Basilar artery aneurysm 11.26 9.42 4 181822 28 64316878
Blood culture positive 11.24 9.42 48 181778 7820 64309086
Delirium 11.14 9.42 133 181693 69061 64247845
Breast cancer stage III 11.09 9.42 25 181801 2880 64314026
Hypoperfusion 11.06 9.42 22 181804 2324 64314582
Hypercapnia 11.04 9.42 47 181779 7647 64309259
Femur fracture 11.04 9.42 54 181772 34081 64282825
Psychotic disorder 11.01 9.42 55 181771 34523 64282383
Visual pathway disorder 10.97 9.42 5 181821 71 64316835
Tinea infection 10.91 9.42 14 181812 1018 64315888
Acute graft versus host disease 10.90 9.42 6 181820 9078 64307828
Blood thyroid stimulating hormone decreased 10.88 9.42 36 181790 5194 64311712
Adverse event 10.87 9.42 164 181662 39325 64277581
Purpura 10.86 9.42 20 181806 17226 64299680
Sedation complication 10.84 9.42 8 181818 10346 64306560
Gonadotrophin deficiency 10.80 9.42 4 181822 32 64316874
Fatigue 10.75 9.42 2326 179500 746404 63570502
Treatment noncompliance 10.74 9.42 75 181751 43407 64273499
Akathisia 10.68 9.42 10 181816 11500 64305406
Coronary artery dissection 10.66 9.42 13 181813 897 64316009
Phaeochromocytoma crisis 10.66 9.42 8 181818 299 64316607
Vaginal discharge 10.65 9.42 30 181796 3967 64312939
Gram stain positive 10.64 9.42 6 181820 136 64316770
Loss of personal independence in daily activities 10.64 9.42 142 181684 72312 64244594
Lymphocytic hypophysitis 10.63 9.42 9 181817 401 64316505
Toxic leukoencephalopathy 10.61 9.42 13 181813 902 64316004
Ruptured cerebral aneurysm 10.55 9.42 10 181816 517 64316389
Encephalitis autoimmune 10.53 9.42 19 181807 1865 64315041
Bronchial haemorrhage 10.51 9.42 15 181811 1207 64315699
Atrioventricular block 10.50 9.42 11 181815 12004 64304902
Hypomagnesaemia 10.49 9.42 62 181764 37314 64279592
Manipulation 10.49 9.42 5 181821 79 64316827
Encephalitis 10.48 9.42 66 181760 12505 64304401
Periorbital infection 10.43 9.42 5 181821 80 64316826
Agranulocytosis 10.42 9.42 64 181762 38165 64278741
Reaction to preservatives 10.41 9.42 6 181820 142 64316764
Oesophageal adenocarcinoma recurrent 10.39 9.42 4 181822 36 64316870
Increased bronchial secretion 10.34 9.42 24 181802 2818 64314088
Disseminated aspergillosis 10.30 9.42 11 181815 657 64316249
Pneumonia aspiration 10.29 9.42 112 181714 59159 64257747
Thyroglossal cyst infection 10.29 9.42 4 181822 37 64316869
Adenoidectomy 10.27 9.42 5 181821 83 64316823
Eosinophilia 10.25 9.42 64 181762 38012 64278894
Autoimmune nephritis 10.24 9.42 10 181816 537 64316369
Nightmare 10.23 9.42 28 181798 20965 64295941
Right ventricular failure 10.19 9.42 29 181797 21442 64295464
Anorectal disorder 10.14 9.42 19 181807 1920 64314986
Enterococcal sepsis 10.13 9.42 22 181804 2472 64314434
Wrong technique in device usage process 10.12 9.42 24 181802 2858 64314048
Glucocorticoid deficiency 10.10 9.42 10 181816 546 64316360
Meningitis tuberculous 10.10 9.42 14 181812 1097 64315809
Oesophageal candidiasis 10.01 9.42 47 181779 7970 64308936
Respiratory rate increased 10.00 9.42 87 181739 18244 64298662
Herpes simplex hepatitis 9.99 9.42 9 181817 436 64316470
Haematotoxicity 9.99 9.42 13 181813 12883 64304023
Gastrointestinal scarring 9.98 9.42 7 181819 235 64316671
Tuberous sclerosis complex 9.95 9.42 5 181821 89 64316817
Chest pain 9.90 9.42 554 181272 235426 64081480
Oesophageal food impaction 9.89 9.42 8 181818 334 64316572
Dislocation of vertebra 9.89 9.42 25 181801 3099 64313807
Bacterial toxaemia 9.88 9.42 6 181820 157 64316749
Blood glucose increased 9.87 9.42 206 181620 97867 64219039
Skin ulcer 9.83 9.42 78 181748 43896 64273010
Pituitary-dependent Cushing's syndrome 9.83 9.42 3 181823 12 64316894
Dysgeusia 9.82 9.42 85 181741 46962 64269944
Granulocytopenia 9.77 9.42 9 181817 10431 64306475
Feeling hot 9.76 9.42 182 181644 45481 64271425
Ocular procedural complication 9.75 9.42 9 181817 450 64316456
Sinusitis 9.75 9.42 504 181322 145424 64171482
Blood luteinising hormone decreased 9.74 9.42 6 181820 161 64316745
Proteus infection 9.74 9.42 17 181809 1626 64315280
Atrioventricular block complete 9.73 9.42 16 181810 14402 64302504
Pharyngitis bacterial 9.73 9.42 7 181819 245 64316661
Device difficult to use 9.71 9.42 8 181818 9790 64307116
Fungaemia 9.68 9.42 28 181798 3757 64313149
Hyperreflexia 9.68 9.42 4 181822 7144 64309762
Perineal pain 9.66 9.42 13 181813 990 64315916
Therapy interrupted 9.56 9.42 27 181799 20009 64296897
Idiopathic intracranial hypertension 9.55 9.42 22 181804 2571 64314335
Transient aphasia 9.55 9.42 6 181820 167 64316739
Genital rash 9.52 9.42 12 181814 857 64316049
Diaphragm muscle weakness 9.52 9.42 6 181820 168 64316738
Botulism 9.51 9.42 8 181818 353 64316553
White blood cell count increased 9.47 9.42 130 181696 65884 64251022
Vaccination site inflammation 9.45 9.42 4 181822 47 64316859
Cardiac failure chronic 9.44 9.42 7 181819 9034 64307872
Quadriplegia 9.42 9.42 24 181802 2989 64313917

FDA Adverse Event Reporting System (Pediatric)

None

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 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 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 R01AD60 RESPIRATORY SYSTEM
NASAL PREPARATIONS
DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
Corticosteroids
ATC S01BA02 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Corticosteroids, plain
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 S01CB03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Corticosteroids/antiinfectives/mydriatics in combination
ATC S02BA01 SENSORY ORGANS
OTOLOGICALS
CORTICOSTEROIDS
Corticosteroids
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 drugs
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:88188 allergenic drug

Drug Use | Suggest Off label Use Form| |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
Erythroblastic Anemia indication
Mastoidectomy Cavity Infections indication
Minor Bacterial Skin Infections indication
Staphylococcus Aureus Otitis Externa indication
Superficial Ocular Infection indication
Transfusion Reaction Urticaria indication
Synovitis due to Osteoarthritis indication
Diagnostic Test for Cushing's Syndrome indication
Gingival Disorders indication
Systemic Dermatomyositis 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 Eczema off-label use
Neonatal Bronchopulmonary Dysplasia off-label use
Congenital Pituitary Hypoplasia off-label use
Otitis Externa Seborrhea 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




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Acute otitis externa Indication
Cats Chronic otitis externa Indication
Cats Ear canker Indication
Cats Inflammatory conditions of the external ear canal Indication
Cats Allergy Indication
Cats Infectious skin conditions Indication
Cats Traumatic skin conditions Indication
Cats Prevention of bacterial infections in superficial wounds Indication
Cats Prevention of bacterial infections in cuts Indication
Cats Prevention of bacterial infections in abrasions Indication
Cats Allergic dermatoses Indication
Cats Infections associated with minor burns and wounds Indication
Cats Nonspecific pruritus Indication
Dogs Acute otitis externa Indication
Dogs Chronic otitis externa Indication
Dogs Ear canker Indication
Dogs Inflammatory conditions of the external ear canal Indication
Dogs Allergy Indication
Dogs Infectious skin conditions Indication
Dogs Traumatic skin conditions Indication
Dogs Prevention of bacterial infections in superficial wounds Indication
Dogs Prevention of bacterial infections in cuts Indication
Dogs Prevention of bacterial infections in abrasions Indication
Dogs Allergic dermatoses Indication
Dogs Infections associated with minor burns and wounds Indication
Dogs Nonspecific pruritus Indication
Horses No Use Class Stated Or Implied Indication

🐶 Veterinary products

ProductApplicantIngredients
Liqua-Cortril Spray, Terra-Cortril Spray Zoetis Inc. 2
Cortisporin Veterinary Ophthalmic Ointment Intervet Inc. 4

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
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0078-0855 SUSPENSION/ DROPS 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