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

Stem definitionDrug idCAS RN
corticosteroids, except prednisolone derivatives 4213 50-03-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • hydrocortisone acetate
  • cortisol acetate
  • hydroxycorticosterone acetate
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: 404.50
  • Formula: C23H32O6
  • CLOGP: 2.42
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 100.90
  • ALOGS: -3.84
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.23 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Dec. 21, 1951 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 704.00 10.89 1720 152270 243801 63091231
Rheumatoid factor positive 691.62 10.89 935 153055 83471 63251561
Pericarditis 662.37 10.89 1163 152827 130416 63204616
Anti-cyclic citrullinated peptide antibody positive 622.59 10.89 1056 152934 115156 63219876
Wound 586.42 10.89 1251 152739 162012 63173020
Discomfort 531.66 10.89 1221 152769 166153 63168879
Intentional product use issue 515.59 10.89 1028 152962 126864 63208168
Hand deformity 507.25 10.89 1164 152826 158293 63176739
Duodenal ulcer perforation 483.56 10.89 805 153185 86404 63248628
Glossodynia 463.78 10.89 1207 152783 177669 63157363
Helicobacter infection 462.57 10.89 817 153173 91968 63243064
Rheumatic fever 441.90 10.89 534 153456 42577 63292455
Systemic lupus erythematosus 424.15 10.89 1290 152700 207628 63127404
Pemphigus 414.51 10.89 1178 152812 182548 63152484
Hepatic enzyme increased 410.42 10.89 1249 152741 201079 63133953
Synovitis 402.89 10.89 1179 152811 185739 63149293
Swollen joint count increased 345.91 10.89 432 153558 35622 63299410
Type 2 diabetes mellitus 337.25 10.89 577 153413 63291 63271741
Arthropathy 318.07 10.89 1268 152722 233524 63101508
Product use issue 314.15 10.89 1210 152780 219310 63115722
Swelling 300.56 10.89 1393 152597 273985 63061047
Condition aggravated 296.59 10.89 1826 152164 400391 62934641
Blister 291.22 10.89 831 153159 128983 63206049
Blood cholesterol increased 285.05 10.89 674 153316 93358 63241674
Fall 268.09 10.89 335 153655 391999 62943033
Adrenocortical insufficiency acute 258.80 10.89 111 153879 1587 63333445
Death 257.52 10.89 318 153672 374063 62960969
Hypersensitivity 248.68 10.89 1380 152610 291305 63043727
Maternal exposure during pregnancy 241.99 10.89 1116 152874 218946 63116086
Toxicity to various agents 238.35 10.89 153 153837 247097 63087935
Abdominal discomfort 234.49 10.89 1454 152536 319431 63015601
Treatment failure 216.26 10.89 1006 152984 198037 63136995
Alopecia 215.23 10.89 1478 152512 336058 62998974
Hip arthroplasty 197.75 10.89 388 153602 47258 63287774
Drug intolerance 187.54 10.89 1336 152654 307325 63027707
Off label use 173.97 10.89 2441 151549 672021 62663011
Steroid withdrawal syndrome 166.44 10.89 59 153931 486 63334546
Injury 153.64 10.89 458 153532 72789 63262243
Rash 152.60 10.89 2050 151940 558821 62776211
Folliculitis 146.85 10.89 439 153551 69878 63265154
Liver injury 143.00 10.89 395 153595 60125 63274907
Knee arthroplasty 142.43 10.89 368 153622 53838 63281194
Fibromyalgia 140.41 10.89 472 153518 79948 63255084
Irritable bowel syndrome 139.76 10.89 479 153511 81933 63253099
Drug abuse 137.31 10.89 10 153980 72508 63262524
Drug interaction 132.24 10.89 220 153770 228911 63106121
Prescribed overdose 129.61 10.89 268 153722 33885 63301147
Adrenal insufficiency 129.44 10.89 187 153803 17728 63317304
General physical health deterioration 128.74 10.89 883 153107 200519 63134513
Inappropriate schedule of product administration 125.94 10.89 543 153447 103422 63231610
Product dose omission issue 123.52 10.89 238 153752 234075 63100957
Joint swelling 123.17 10.89 1275 152715 326391 63008641
Muscle injury 120.74 10.89 391 153599 64954 63270078
Contraindicated product administered 117.76 10.89 917 153073 216731 63118301
Overdose 115.24 10.89 68 153922 115010 63220022
Intentional overdose 111.71 10.89 22 153968 74130 63260902
Musculoskeletal stiffness 109.53 10.89 795 153195 183823 63151209
Therapeutic product effect decreased 107.30 10.89 819 153171 192368 63142664
Blood pressure fluctuation 107.13 10.89 300 153690 46017 63289015
Deep vein thrombosis postoperative 107.04 10.89 135 153855 11234 63323798
Psoriatic arthropathy 107.02 10.89 473 153517 91047 63243985
Cardiac failure congestive 103.86 10.89 47 153943 92386 63242646
Febrile bone marrow aplasia 102.91 10.89 107 153883 7218 63327814
Drug tolerance decreased 101.71 10.89 165 153825 17308 63317724
Adjustment disorder with depressed mood 97.40 10.89 122 153868 10082 63324950
Myocardial infarction 97.26 10.89 61 153929 99832 63235200
Live birth 97.11 10.89 201 153789 25429 63309603
Sleep disorder due to general medical condition, insomnia type 95.15 10.89 311 153679 51906 63283126
Facet joint syndrome 92.55 10.89 130 153860 12008 63323024
X-ray abnormal 92.23 10.89 106 153884 8004 63327028
Lupus vulgaris 90.46 10.89 91 153899 5903 63329129
Injection site pain 88.24 10.89 111 153879 129689 63205343
Autoimmune disorder 87.73 10.89 153 153837 17024 63318008
Mobility decreased 87.56 10.89 548 153442 120611 63214421
Lip dry 87.22 10.89 144 153846 15326 63319706
Drug level below therapeutic 86.84 10.89 81 153909 4785 63330247
Wheezing 86.49 10.89 459 153531 95136 63239896
Acute kidney injury 85.99 10.89 338 153652 263077 63071955
Hypofibrinogenaemia 84.98 10.89 46 153944 1124 63333908
Anti-cyclic citrullinated peptide antibody 84.85 10.89 93 153897 6665 63328367
Colitis ulcerative 84.43 10.89 192 153798 25899 63309133
Adverse event 81.12 10.89 352 153638 67207 63267825
Peripheral venous disease 80.54 10.89 139 153851 15338 63319694
Cerebrovascular accident 80.30 10.89 86 153904 107938 63227094
Product use in unapproved indication 79.52 10.89 722 153268 178358 63156674
Dislocation of vertebra 78.87 10.89 101 153889 8534 63326498
Anaemia 75.33 10.89 411 153579 293019 63042013
Platelet count decreased 73.15 10.89 105 153885 116017 63219015
Exposure during pregnancy 71.55 10.89 632 153358 154915 63180117
Balance disorder 71.18 10.89 60 153930 84362 63250670
Multiple sclerosis relapse 69.70 10.89 16 153974 48462 63286570
Nausea 69.64 10.89 1562 152428 852909 62482123
White blood cell count decreased 69.22 10.89 146 153844 138958 63196074
Atrial fibrillation 68.15 10.89 111 153879 116525 63218507
Frequent bowel movements 67.50 10.89 163 153827 22859 63312173
Craniopharyngioma 67.49 10.89 22 153968 136 63334896
Suicide attempt 66.84 10.89 32 153958 60886 63274146
Haemoglobin decreased 66.44 10.89 160 153830 145325 63189707
Lower respiratory tract infection 65.79 10.89 547 153443 131760 63203272
Device expulsion 65.57 10.89 5 153985 34917 63300115
Renal impairment 64.93 10.89 71 153919 88284 63246748
Cognitive disorder 64.89 10.89 27 153963 55788 63279244
Sedation 64.03 10.89 9 153981 38800 63296232
Impaired healing 63.90 10.89 447 153543 102095 63232937
Secondary adrenocortical insufficiency 63.79 10.89 41 153949 1387 63333645
Prescribed underdose 63.51 10.89 187 153803 29502 63305530
Adverse drug reaction 62.29 10.89 368 153622 79346 63255686
Interstitial lung disease 61.37 10.89 37 153953 61871 63273161
Feeling abnormal 61.03 10.89 172 153818 148220 63186812
Wrong technique in product usage process 60.77 10.89 38 153952 62302 63272730
Breast cancer 60.25 10.89 21 153969 48362 63286670
Chronic obstructive pulmonary disease 60.02 10.89 39 153951 62647 63272385
Tremor 59.93 10.89 146 153844 132093 63202939
Injection site erythema 59.85 10.89 68 153922 83106 63251926
Syncope 59.41 10.89 122 153868 117263 63217769
Breast cancer stage III 58.99 10.89 97 153893 10289 63324743
Joint range of motion decreased 58.94 10.89 193 153797 32235 63302797
Grip strength decreased 58.20 10.89 151 153839 22136 63312896
Bronchitis 57.36 10.89 137 153853 124798 63210234
Suicidal ideation 56.88 10.89 41 153949 62380 63272652
Asthenia 55.46 10.89 629 153361 382975 62952057
Pulmonary fibrosis 55.33 10.89 217 153773 39592 63295440
Urticaria 54.23 10.89 628 153362 165174 63169858
Malignant neoplasm progression 53.97 10.89 72 153918 82049 63252983
Coma 53.94 10.89 46 153944 64318 63270714
Pituitary tumour benign 53.61 10.89 42 153948 1953 63333079
Ill-defined disorder 51.88 10.89 358 153632 81397 63253635
Dehydration 51.83 10.89 230 153760 173124 63161908
Cardiac failure 50.98 10.89 86 153904 89056 63245976
Full blood count abnormal 50.84 10.89 8 153982 31709 63303323
Wound infection 49.81 10.89 139 153851 21271 63313761
Blood creatinine increased 49.09 10.89 86 153904 87758 63247274
Depressed level of consciousness 46.59 10.89 49 153941 62029 63273003
Hypertension 46.23 10.89 942 153048 278361 63056671
Female genital tract fistula 46.21 10.89 73 153917 7486 63327546
Cataract 45.15 10.89 43 153947 57010 63278022
Electrocardiogram QT prolonged 43.56 10.89 48 153942 59482 63275550
Cardiac disorder 42.97 10.89 36 153954 50780 63284252
Somnolence 42.72 10.89 256 153734 178429 63156603
Hypercholesterolaemia 42.45 10.89 131 153859 21203 63313829
Urinary tract infection 42.25 10.89 424 153566 264260 63070772
Neutropenia 42.22 10.89 250 153740 174755 63160277
Therapy cessation 41.94 10.89 11 153979 30446 63304586
Hospitalisation 41.72 10.89 90 153900 84991 63250041
Poor venous access 41.55 10.89 103 153887 14682 63320350
Femur fracture 41.32 10.89 25 153965 41731 63293301
Human bocavirus infection 40.88 10.89 20 153970 393 63334639
Loss of consciousness 40.80 10.89 148 153842 117973 63217059
Hyperadrenocorticism 40.75 10.89 19 153971 334 63334698
Gastrointestinal haemorrhage 40.53 10.89 85 153905 81091 63253941
Unevaluable event 40.35 10.89 39 153951 51347 63283685
Intentional self-injury 40.01 10.89 7 153983 25680 63309352
Renal failure 39.60 10.89 149 153841 117503 63217529
Alanine aminotransferase increased 39.26 10.89 125 153865 103645 63231387
Respiratory arrest 39.24 10.89 15 153975 32630 63302402
Stomatitis 39.10 10.89 511 153479 138214 63196818
Therapeutic response shortened 39.03 10.89 88 153902 11800 63323232
Herpes zoster 38.98 10.89 89 153901 82373 63252659
Lower limb fracture 38.62 10.89 138 153852 24083 63310949
Back pain 38.57 10.89 432 153558 263713 63071319
Aspartate aminotransferase increased 38.33 10.89 103 153887 90174 63244858
Myalgia 38.23 10.89 204 153786 146325 63188707
Disease progression 37.82 10.89 161 153829 122597 63212435
Fluid retention 37.54 10.89 54 153936 59632 63275400
Adrenal suppression 37.54 10.89 25 153965 899 63334133
Blood glucose increased 37.52 10.89 93 153897 83663 63251369
Drug level decreased 37.18 10.89 68 153922 7851 63327181
Cardio-respiratory arrest 36.98 10.89 55 153935 59904 63275128
Leukopenia 36.88 10.89 83 153907 77207 63257825
Faecal calprotectin increased 36.65 10.89 42 153948 3161 63331871
Oedema 36.60 10.89 380 153610 97242 63237790
Thrombosis 36.54 10.89 63 153927 64692 63270340
Liver function test abnormal 36.19 10.89 38 153952 48143 63286889
Rhinovirus infection 35.26 10.89 49 153941 4480 63330552
Injection site swelling 35.20 10.89 38 153952 47534 63287498
Renal disorder 35.15 10.89 18 153972 32956 63302076
Osteonecrosis of jaw 34.80 10.89 21 153969 35102 63299930
Serotonin syndrome 34.77 10.89 13 153977 28669 63306363
Steroid dependence 34.67 10.89 31 153959 1733 63333299
Vision blurred 34.58 10.89 111 153879 91813 63243219
Anal fissure 34.49 10.89 48 153942 4395 63330637
Drug level above therapeutic 34.48 10.89 50 153940 4755 63330277
Diarrhoea 34.18 10.89 1404 152586 713962 62621070
Hallucination 34.08 10.89 50 153940 54767 63280265
Walking aid user 33.71 10.89 78 153912 10639 63324393
Obesity 33.63 10.89 153 153837 29799 63305233
Depression 33.35 10.89 310 153680 196182 63138850
Eczema 32.64 10.89 160 153830 32131 63302901
Pneumonia 32.61 10.89 851 153139 455916 62879116
Accidental exposure to product 32.27 10.89 13 153977 27392 63307640
Drug withdrawal syndrome 31.85 10.89 13 153977 27181 63307851
Salpingo-oophorectomy unilateral 31.44 10.89 22 153968 859 63334173
Urticaria thermal 31.16 10.89 17 153973 422 63334610
Injection site reaction 30.30 10.89 60 153930 58464 63276568
Thrombocytopenia 29.92 10.89 229 153761 150928 63184104
Coronary artery disease 29.84 10.89 21 153969 32356 63302676
Dermatitis atopic 29.74 10.89 70 153920 9654 63325378
Hypothalamo-pituitary disorder 29.70 10.89 20 153970 733 63334299
Chronic kidney disease 29.62 10.89 40 153950 45358 63289674
Hepatic function abnormal 29.38 10.89 28 153962 37114 63297918
Hyperhidrosis 29.32 10.89 148 153842 107688 63227344
Contusion 28.87 10.89 518 153472 149526 63185506
Pleural effusion 28.86 10.89 122 153868 93088 63241944
Bone disorder 28.80 10.89 8 153982 21318 63313714
Night sweats 28.77 10.89 210 153780 48604 63286428
Perfume sensitivity 28.49 10.89 20 153970 785 63334247
Plasma cell myeloma 28.48 10.89 27 153963 35878 63299154
Rheumatoid nodule 28.25 10.89 4 153986 17151 63317881
Hypothalamic pituitary adrenal axis suppression 28.20 10.89 12 153978 168 63334864
Sleep disorder 28.02 10.89 312 153678 81254 63253778
Body temperature fluctuation 27.91 10.89 31 153959 2254 63332778
Dyspepsia 27.77 10.89 374 153616 101822 63233210
Bursitis 27.65 10.89 169 153821 36872 63298160
Arrhythmia 27.63 10.89 31 153959 38109 63296923
Migraine 27.58 10.89 377 153613 102969 63232063
Dizziness 27.58 10.89 813 153177 429112 62905920
Therapy interrupted 27.43 10.89 23 153967 32432 63302600
Lung neoplasm malignant 27.20 10.89 7 153983 19626 63315406
Natural killer-cell leukaemia 27.15 10.89 10 153980 93 63334939
Heart rate irregular 27.03 10.89 117 153873 22304 63312728
Normal tension glaucoma 27.01 10.89 8 153982 34 63334998
C-reactive protein 26.92 10.89 45 153945 4837 63330195
Oedema peripheral 26.83 10.89 312 153678 189199 63145833
Metastases to liver 26.57 10.89 12 153978 23627 63311405
Metastases to bone 26.38 10.89 9 153981 21010 63314022
Cough 26.34 10.89 526 153464 292217 63042815
Excessive eye blinking 26.17 10.89 23 153967 1257 63333775
Device dislocation 25.98 10.89 15 153975 25690 63309342
Transient ischaemic attack 25.94 10.89 32 153958 37721 63297311
Vaginal discharge 25.76 10.89 64 153926 9134 63325898
Antithrombin III 25.72 10.89 11 153979 156 63334876
Acute myocardial infarction 25.66 10.89 24 153966 32100 63302932
Diverticulitis 25.66 10.89 35 153955 39522 63295510
Dyskinesia 25.46 10.89 24 153966 31978 63303054
Asphyxia 25.22 10.89 50 153940 6131 63328901
Faecal volume decreased 25.11 10.89 11 153979 166 63334866
Hip fracture 24.77 10.89 21 153969 29453 63305579
Agitation 24.75 10.89 69 153921 59688 63275344
Cortisol decreased 24.73 10.89 22 153968 1222 63333810
Vaginal flatulence 24.70 10.89 35 153955 3258 63331774
Herpes simplex oesophagitis 24.64 10.89 11 153979 174 63334858
Proctitis 24.64 10.89 46 153944 5395 63329637
Secondary immunodeficiency 24.64 10.89 23 153967 1360 63333672
No adverse event 24.55 10.89 39 153951 41366 63293666
Epistaxis 24.53 10.89 92 153898 72633 63262399
Orthostatic hypotension 24.48 10.89 31 153959 36129 63298903
Diabetes insipidus 24.44 10.89 31 153959 2594 63332438
Febrile neutropenia 24.24 10.89 413 153577 118036 63216996
Therapy non-responder 24.12 10.89 286 153704 75615 63259417
Constipation 24.07 10.89 392 153598 224551 63110481
Blood creatine phosphokinase increased 24.00 10.89 23 153967 30407 63304625
Musculoskeletal disorder 23.97 10.89 10 153980 20634 63314398
Insulin-like growth factor increased 23.95 10.89 19 153971 900 63334132
Melaena 23.89 10.89 23 153967 30342 63304690
Influenza 23.79 10.89 160 153830 108562 63226470
Aphasia 23.71 10.89 27 153963 32973 63302059
Perioral dermatitis 23.68 10.89 12 153978 255 63334777
Hypotension 23.57 10.89 493 153497 272111 63062921
Gastroenteritis norovirus 23.47 10.89 27 153963 2041 63332991
Intentional product misuse 23.30 10.89 73 153917 60844 63274188
Skin ulcer 23.27 10.89 43 153947 43002 63292030
Palpitations 23.19 10.89 169 153821 112601 63222431
Pruritus 23.13 10.89 1085 152905 360368 62974664
Haematuria 23.04 10.89 22 153968 29135 63305897
Carpal tunnel syndrome 22.73 10.89 11 153979 20806 63314226
Strongyloidiasis 22.70 10.89 21 153969 1227 63333805
Ulcer 22.69 10.89 18 153972 26089 63308943
Sinusitis fungal 22.64 10.89 25 153965 1806 63333226
Ascites 22.63 10.89 40 153950 40688 63294344
Seizure 22.60 10.89 209 153781 132425 63202607
Injection site bruising 22.54 10.89 42 153948 41868 63293164
Cardiac arrest 22.41 10.89 132 153858 92413 63242619
Rheumatoid arthritis 22.24 10.89 458 153532 253361 63081671
Gait inability 22.20 10.89 211 153779 52748 63282284
Sciatica 22.17 10.89 151 153839 34173 63300859
Insomnia 22.08 10.89 378 153612 214874 63120158
International normalised ratio increased 22.02 10.89 50 153940 46375 63288657
Product quality issue 22.01 10.89 33 153957 35832 63299200
Bradycardia 21.96 10.89 97 153893 73130 63261902
Dysarthria 21.93 10.89 44 153946 42667 63292365
Complication associated with device 21.78 10.89 7 153983 16971 63318061
C-reactive protein abnormal 21.53 10.89 188 153802 45908 63289124
Cerebral infarction 21.37 10.89 16 153974 23877 63311155
Aspergillus infection 21.30 10.89 55 153935 8038 63326994
Septic shock 21.15 10.89 251 153739 66378 63268654
Allergy test positive 21.01 10.89 15 153975 605 63334427
Hepatotoxicity 20.93 10.89 36 153954 37005 63298027
Neoplasm malignant 20.84 10.89 25 153965 29836 63305196
Gastrooesophageal reflux disease 20.80 10.89 141 153849 95498 63239534
Drug hypersensitivity 20.79 10.89 584 153406 310103 63024929
Abortion spontaneous 20.67 10.89 53 153937 47142 63287890
Catarrh 20.64 10.89 22 153968 1527 63333505
Mucous stools 20.61 10.89 37 153953 4211 63330821
Diaphragm muscle weakness 20.55 10.89 6 153984 24 63335008
Upper gastrointestinal haemorrhage 20.53 10.89 10 153980 18842 63316190
Breast cancer female 20.46 10.89 4 153986 13555 63321477
Red blood cell count decreased 19.92 10.89 43 153947 40602 63294430
Gastrointestinal disorder 19.84 10.89 437 153553 130802 63204230
Airway peak pressure increased 19.78 10.89 11 153979 284 63334748
Neoplasm recurrence 19.73 10.89 28 153962 2610 63332422
Blood calcium decreased 19.71 10.89 21 153969 26430 63308602
Road traffic accident 19.57 10.89 154 153836 36478 63298554
Injection site pruritus 19.50 10.89 51 153939 45065 63289967
Cholelithiasis 19.49 10.89 49 153941 43876 63291156
Neuroleptic malignant syndrome 19.41 10.89 3 153987 12053 63322979
Pulmonary hypertension 19.27 10.89 38 153952 37085 63297947
Hypogonadism 19.27 10.89 8 153982 105 63334927
Insulin-like growth factor decreased 19.26 10.89 12 153978 384 63334648
Dry eye 19.25 10.89 44 153946 40717 63294315
Eczema herpeticum 19.21 10.89 9 153981 160 63334872
Dysstasia 19.15 10.89 14 153976 21152 63313880
Weight increased 19.13 10.89 794 153196 259998 63075034
Hepatic steatosis 19.12 10.89 25 153965 28744 63306288
Pulmonary arterial hypertension 19.08 10.89 16 153974 22561 63312471
Mitral valve incompetence 19.01 10.89 12 153978 19582 63315450
Drug eruption 19.01 10.89 25 153965 28669 63306363
Rhabdomyolysis 18.76 10.89 50 153940 43901 63291131
Joint effusion 18.65 10.89 9 153981 17051 63317981
Blood pressure diastolic abnormal 18.65 10.89 6 153984 14536 63320496
Seronegative arthritis 18.59 10.89 34 153956 3925 63331107
Blood potassium decreased 18.56 10.89 47 153943 41979 63293053
Pain in extremity 18.55 10.89 638 153352 330848 63004184
Pseudohypoaldosteronism 18.48 10.89 5 153985 14 63335018
Erythema nodosum 18.19 10.89 38 153952 4837 63330195
Tooth disorder 18.18 10.89 25 153965 28132 63306900
Vertigo 18.15 10.89 79 153911 59808 63275224
Vaginal haemorrhage 18.15 10.89 24 153966 27463 63307569
Angina pectoris 18.15 10.89 28 153962 30050 63304982
Torsade de pointes 18.04 10.89 5 153985 13346 63321686
Hepatitis 17.96 10.89 44 153946 39744 63295288
Full blood count decreased 17.94 10.89 22 153968 26002 63309030
Visual acuity reduced 17.80 10.89 16 153974 21810 63313222
Surgery 17.59 10.89 38 153952 35874 63299158
Hypophysitis 17.55 10.89 22 153968 1819 63333213
Blood alkaline phosphatase increased 17.50 10.89 50 153940 42917 63292115
Rectal haemorrhage 17.50 10.89 189 153801 48841 63286191
Product prescribing error 17.32 10.89 23 153967 26266 63308766
Embolism venous 17.30 10.89 29 153961 3125 63331907
Creatinine renal clearance decreased 17.23 10.89 9 153981 16299 63318733
Restlessness 17.22 10.89 28 153962 29425 63305607
Tenosynovitis 17.15 10.89 6 153984 13789 63321243
Hypophagia 17.10 10.89 31 153959 31228 63303804
Myocardial ischaemia 17.04 10.89 5 153985 12854 63322178
Cystitis 17.00 10.89 72 153918 54919 63280113
Platelet count increased 16.98 10.89 11 153979 17700 63317332
Enterococcal sepsis 16.91 10.89 19 153971 1399 63333633
Sputum increased 16.79 10.89 25 153965 2434 63332598
Cellulitis 16.76 10.89 123 153867 81835 63253197
Neutrophil count decreased 16.74 10.89 75 153915 56331 63278701
Nervousness 16.70 10.89 31 153959 30948 63304084
Proctalgia 16.57 10.89 42 153948 6068 63328964
Blood urea increased 16.45 10.89 24 153966 26355 63308677
Secondary hypogonadism 16.45 10.89 7 153983 98 63334934
Myelosuppression 16.38 10.89 20 153970 23683 63311349
Burns second degree 16.30 10.89 22 153968 1956 63333076
Dyspnoea exertional 16.25 10.89 83 153907 60219 63274813
Retinitis 16.20 10.89 42 153948 6154 63328878
Mental status changes 16.19 10.89 46 153944 39553 63295479
Muscle rigidity 16.13 10.89 4 153986 11496 63323536
Basal cell carcinoma 16.00 10.89 27 153963 27964 63307068
Parkinsonism 15.92 10.89 3 153987 10436 63324596
Synovial cyst 15.91 10.89 3 153987 10430 63324602
Panniculitis 15.89 10.89 4 153986 11381 63323651
Urinary retention 15.74 10.89 31 153959 30270 63304762
Onychomadesis 15.69 10.89 40 153950 5800 63329232
Rib fracture 15.68 10.89 19 153971 22578 63312454
Hypothyroidism 15.67 10.89 52 153938 42580 63292452
Maternal exposure timing unspecified 15.50 10.89 45 153945 7042 63327990
Hypoaldosteronism 15.41 10.89 8 153982 179 63334853
Arteriosclerosis coronary artery 15.36 10.89 50 153940 8323 63326709
Cerebral microangiopathy 15.33 10.89 9 153981 258 63334774
Haematoma 15.33 10.89 39 153951 34781 63300251
Lactic acidosis 15.27 10.89 45 153945 38242 63296790
Dyspnoea 15.25 10.89 1389 152601 659924 62675108
Chromaturia 15.20 10.89 11 153979 16706 63318326
Metastases to lung 15.09 10.89 6 153984 12744 63322288
Mastocytosis 15.02 10.89 12 153978 574 63334458
Blepharospasm 15.02 10.89 40 153950 5956 63329076
Osteomyelitis 14.97 10.89 25 153965 25995 63309037
Hyperemesis gravidarum 14.91 10.89 12 153978 580 63334452
Schizophrenia 14.88 10.89 3 153987 9949 63325083
Nerve injury 14.87 10.89 3 153987 9943 63325089
Aplastic anaemia 14.81 10.89 54 153936 9515 63325517
Eye injury 14.77 10.89 26 153964 2913 63332119
Intervertebral disc degeneration 14.77 10.89 10 153980 15722 63319310
Hypoperfusion 14.74 10.89 18 153972 1449 63333583
Foot fracture 14.68 10.89 22 153968 23892 63311140
Ventricular extrasystoles 14.67 10.89 5 153985 11682 63323350
Deformity 14.67 10.89 5 153985 11679 63323353
Haematochezia 14.56 10.89 196 153794 53348 63281684
Drug specific antibody present 14.51 10.89 32 153958 4227 63330805
PO2 decreased 14.36 10.89 18 153972 1488 63333544
Pneumatosis intestinalis 14.33 10.89 23 153967 2390 63332642
Injection site haemorrhage 14.32 10.89 23 153967 24291 63310741
Enterobacter infection 14.30 10.89 22 153968 2205 63332827
Bone pain 14.28 10.89 76 153914 54565 63280467
Nodule 14.26 10.89 18 153972 21008 63314024
Head injury 14.26 10.89 28 153962 27368 63307664
Blood potassium increased 14.25 10.89 14 153976 18295 63316737
Bone density decreased 14.11 10.89 9 153981 14603 63320429
Dysphagia 14.07 10.89 142 153848 88443 63246589
Dystonia 14.06 10.89 8 153982 13811 63321221
Hypersomnia 13.83 10.89 14 153976 18041 63316991
Renal injury 13.80 10.89 3 153987 9436 63325596
Sensory disturbance 13.79 10.89 8 153982 13664 63321368
Norovirus test positive 13.74 10.89 8 153982 226 63334806
Faecal calprotectin abnormal 13.73 10.89 6 153984 90 63334942
Injection site mass 13.69 10.89 15 153975 18641 63316391
Breast cancer metastatic 13.67 10.89 6 153984 12012 63323020
Fear 13.54 10.89 11 153979 15755 63319277
Rotator cuff syndrome 13.48 10.89 8 153982 13494 63321538
Palmar-plantar erythrodysaesthesia syndrome 13.34 10.89 22 153968 22993 63312039
Therapeutic product effect incomplete 13.34 10.89 218 153772 124838 63210194
Tessellated fundus 13.25 10.89 5 153985 50 63334982
Lung hyperinflation 13.19 10.89 16 153974 1279 63333753
Akathisia 13.18 10.89 3 153987 9143 63325889
Localised infection 13.17 10.89 34 153956 30176 63304856
Brachycephaly 13.15 10.89 4 153986 19 63335013
Dysphonia 13.14 10.89 65 153925 47549 63287483
Product label confusion 13.13 10.89 19 153971 1803 63333229
Immunodeficiency 13.06 10.89 18 153972 20236 63314796
Fracture 13.04 10.89 17 153973 19567 63315465
Hypercalcaemia 13.03 10.89 31 153959 28291 63306741
Respiratory tract infection 13.02 10.89 54 153936 41429 63293603
Neoplasm progression 13.00 10.89 45 153945 36383 63298649
White blood cell count increased 12.99 10.89 67 153923 48494 63286538
Anger 12.98 10.89 7 153983 12449 63322583
Spondylitis 12.95 10.89 31 153959 4323 63330709
Colitis 12.93 10.89 177 153813 48351 63286681
Meningitis candida 12.91 10.89 5 153985 54 63334978
Blood cholesterol 12.88 10.89 12 153978 708 63334324
Myelodysplastic syndrome 12.82 10.89 13 153977 16741 63318291
Shared psychotic disorder 12.82 10.89 4 153986 21 63335011
Enterovirus infection 12.81 10.89 14 153976 1000 63334032
Respiratory failure 12.79 10.89 172 153818 101686 63233346
Geotrichum infection 12.78 10.89 10 153980 464 63334568
Dysgeusia 12.75 10.89 64 153926 46646 63288386
Hypertensive crisis 12.71 10.89 11 153979 15275 63319757
Hypernatraemia 12.69 10.89 44 153946 7565 63327467
Leukoencephalopathy 12.67 10.89 31 153959 4382 63330650
Device issue 12.64 10.89 24 153966 23757 63311275
Ventricular tachycardia 12.64 10.89 18 153972 19961 63315071
Tuberculosis gastrointestinal 12.58 10.89 9 153981 364 63334668
Glucocorticoid deficiency 12.52 10.89 8 153982 268 63334764
Respiratory depression 12.50 10.89 9 153981 13706 63321326
Infective pulmonary exacerbation of cystic fibrosis 12.49 10.89 3 153987 8814 63326218
Tongue disorder 12.49 10.89 5 153985 10575 63324457
Lymphocyte count decreased 12.48 10.89 35 153955 30222 63304810
Muscle spasticity 12.48 10.89 21 153969 21773 63313259
Cerebral vasoconstriction 12.43 10.89 15 153975 1193 63333839
Skin weeping 12.42 10.89 12 153978 741 63334291
Urosepsis 12.41 10.89 16 153974 18508 63316524
Respiratory symptom 12.38 10.89 26 153964 3321 63331711
Toxic skin eruption 12.35 10.89 8 153982 12877 63322155
Osteopenia 12.34 10.89 18 153972 19767 63315265
Status asthmaticus 12.33 10.89 13 153977 891 63334141
Drug resistance 12.32 10.89 23 153967 22910 63312122
Dermatitis exfoliative generalised 12.30 10.89 28 153962 3779 63331253
Ligament sprain 12.20 10.89 8 153982 12792 63322240
Ocular procedural complication 12.16 10.89 9 153981 384 63334648
Eating disorder 12.16 10.89 17 153973 18999 63316033
Sputum discoloured 12.16 10.89 13 153977 16334 63318698
Product storage error 12.15 10.89 11 153979 14945 63320087
Poisoning deliberate 12.14 10.89 6 153984 11212 63323820
Blood test abnormal 12.11 10.89 12 153978 15617 63319415
Speech disorder 12.07 10.89 54 153936 40575 63294457
Hypomagnesaemia 12.03 10.89 33 153957 28704 63306328
Splenomegaly 12.02 10.89 6 153984 11151 63323881
Disability 12.02 10.89 81 153909 18266 63316766
Affect lability 12.01 10.89 6 153984 11145 63323887
Radiculopathy 12.01 10.89 47 153943 8564 63326468
Psychotic disorder 11.95 10.89 28 153962 25684 63309348
Jaundice 11.94 10.89 34 153956 29217 63305815
Infusion site streaking 11.88 10.89 10 153980 515 63334517
Tardive dyskinesia 11.84 10.89 3 153987 8499 63326533
Haemorrhage 11.80 10.89 93 153897 60929 63274103
Haematotoxicity 11.79 10.89 4 153986 9372 63325660
Cardiovascular disorder 11.79 10.89 7 153983 11805 63323227
Extrapyramidal disorder 11.74 10.89 9 153981 13275 63321757
Pulmonary congestion 11.72 10.89 15 153975 17403 63317629
Colitis microscopic 11.72 10.89 4 153986 9335 63325697
Herpes simplex hepatitis 11.67 10.89 9 153981 409 63334623
Neutropenic sepsis 11.64 10.89 74 153916 16364 63318668
Limb injury 11.63 10.89 28 153962 25449 63309583
Rhinitis allergic 11.63 10.89 7 153983 11720 63323312
Autoimmune nephritis 11.59 10.89 9 153981 413 63334619
Anorectal discomfort 11.56 10.89 22 153968 2617 63332415
Musculoskeletal discomfort 11.55 10.89 16 153974 17951 63317081
Ischaemic stroke 11.53 10.89 16 153974 17941 63317091
Ulcer haemorrhage 11.45 10.89 34 153956 5388 63329644
Pneumonia aspiration 11.45 10.89 44 153946 34496 63300536
Blood pressure abnormal 11.40 10.89 12 153978 15186 63319846
Hypopituitarism 11.40 10.89 14 153976 1134 63333898
Injection site warmth 11.39 10.89 12 153978 15183 63319849
Device malfunction 11.38 10.89 16 153974 17841 63317191
Coordination abnormal 11.35 10.89 10 153980 13763 63321269
Diabetes mellitus inadequate control 11.28 10.89 12 153978 15114 63319918
Subacute combined cord degeneration 11.27 10.89 7 153983 223 63334809
Heavy menstrual bleeding 11.25 10.89 16 153974 17757 63317275
Anxiety 11.17 10.89 423 153567 217118 63117914
Pituitary infarction 11.17 10.89 4 153986 34 63334998
Upper limb fracture 11.12 10.89 18 153972 18950 63316082
Cystitis bacterial 11.10 10.89 7 153983 229 63334803
Muscle spasms 11.08 10.89 291 153699 155859 63179173
Abnormal behaviour 11.06 10.89 22 153968 21404 63313628
Vaginal abscess 10.99 10.89 9 153981 446 63334586
Human herpesvirus 6 infection 10.98 10.89 23 153967 2934 63332098
Oesophageal adenocarcinoma recurrent 10.97 10.89 4 153986 36 63334996
Gastric disorder 10.90 10.89 50 153940 37319 63297713

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
Intentional product use issue 346.88 10.27 489 64608 59327 34832507
Blood pressure fluctuation 299.77 10.27 298 64799 24951 34866883
Off label use 266.44 10.27 1504 63593 418020 34473814
Adrenal insufficiency 243.47 10.27 205 64892 13842 34877992
Inappropriate schedule of product administration 198.24 10.27 389 64708 61907 34829927
Infusion related reaction 190.70 10.27 349 64748 52708 34839126
Condition aggravated 186.92 10.27 780 64317 191416 34700418
Completed suicide 160.06 10.27 5 65092 98163 34793671
Drug abuse 154.88 10.27 7 65090 99089 34792745
Graft loss 150.33 10.27 58 65039 825 34891009
Death 148.80 10.27 326 64771 397723 34494111
Febrile bone marrow aplasia 138.52 10.27 118 64979 8091 34883743
Adrenocortical insufficiency acute 138.38 10.27 65 65032 1535 34890299
Febrile neutropenia 126.30 10.27 547 64550 136302 34755532
Frequent bowel movements 123.14 10.27 135 64962 12652 34879182
Bronchiectasis 120.57 10.27 118 64979 9683 34882151
Serum sickness 118.93 10.27 63 65034 1937 34889897
Toxicity to various agents 117.48 10.27 120 64977 200242 34691592
Adrenal suppression 115.52 10.27 44 65053 603 34891231
Craniopharyngioma 114.65 10.27 36 65061 263 34891571
Aplastic anaemia 112.16 10.27 113 64984 9603 34882231
Heart rate decreased 105.48 10.27 202 64895 31543 34860291
Impaired quality of life 105.12 10.27 87 65010 5731 34886103
Drug level below therapeutic 95.32 10.27 81 65016 5534 34886300
Heart rate irregular 91.12 10.27 129 64968 15678 34876156
Hypofibrinogenaemia 88.79 10.27 49 65048 1637 34890197
Leukoencephalopathy 82.41 10.27 66 65031 4149 34887685
Mucosal inflammation 81.78 10.27 205 64892 38417 34853417
Colitis ulcerative 79.68 10.27 124 64973 16396 34875438
Product use issue 73.70 10.27 272 64825 62944 34828890
Steroid dependence 68.85 10.27 40 65057 1477 34890357
Diabetes insipidus 64.06 10.27 49 65048 2879 34888955
Steroid withdrawal syndrome 63.64 10.27 22 65075 224 34891610
Body temperature fluctuation 62.81 10.27 39 65058 1628 34890206
Drug specific antibody present 61.18 10.27 50 65047 3235 34888599
Septic shock 60.02 10.27 279 64818 71555 34820279
Soft tissue mass 57.50 10.27 31 65066 988 34890846
Eczema 56.00 10.27 113 64984 18323 34873511
Pituitary tumour benign 55.94 10.27 29 65068 852 34890982
Faecal calprotectin increased 54.40 10.27 42 65055 2502 34889332
Multimorbidity 54.11 10.27 29 65068 913 34890921
Hypopituitarism 53.94 10.27 40 65057 2242 34889592
Flushing 50.65 10.27 154 64943 32266 34859568
Oesophageal perforation 50.18 10.27 30 65067 1169 34890665
Gingival disorder 49.09 10.27 32 65065 1455 34890379
Interstitial lung disease 48.27 10.27 31 65066 65251 34826583
Pseudostroke 46.89 10.27 12 65085 36 34891798
Cortisol decreased 46.65 10.27 28 65069 1099 34890735
Myocardial infarction 45.12 10.27 99 64998 120986 34770848
Therapeutic response shortened 45.01 10.27 62 65035 7342 34884492
Hypertriglyceridaemia 44.39 10.27 66 65031 8382 34883452
Blood pressure increased 43.46 10.27 297 64800 87805 34804029
Fall 42.38 10.27 214 64883 202671 34689163
Superinfection 42.06 10.27 36 65061 2483 34889351
Intentional overdose 41.01 10.27 15 65082 43659 34848175
Drug level decreased 40.80 10.27 61 65036 7785 34884049
Drug ineffective 40.74 10.27 1125 63972 455626 34436208
Erythema 40.12 10.27 293 64804 88487 34803347
Hypogonadism 39.24 10.27 33 65064 2222 34889612
Poor venous access 38.66 10.27 48 65049 5135 34886699
Anal inflammation 38.15 10.27 26 65071 1274 34890560
Drug interaction 36.78 10.27 258 64839 225688 34666146
Overdose 35.97 10.27 72 65025 90987 34800847
Dermatitis atopic 35.91 10.27 47 65050 5300 34886534
Weight increased 34.85 10.27 294 64803 92739 34799095
Hallucination 33.47 10.27 28 65069 51470 34840364
Transplant failure 33.31 10.27 37 65060 3516 34888318
Coronary artery disease 32.98 10.27 25 65072 48280 34843554
Oral disorder 32.74 10.27 40 65057 4209 34887625
Chorioretinopathy 32.69 10.27 25 65072 1468 34890366
Myelopathy 32.47 10.27 31 65066 2466 34889368
Rash erythematous 32.09 10.27 111 64986 24866 34866968
Atrial fibrillation 31.68 10.27 119 64978 122274 34769560
Posterior reversible encephalopathy syndrome 31.41 10.27 62 65035 9892 34881942
Suicide attempt 31.13 10.27 17 65080 39099 34852735
Blood pressure diastolic decreased 30.35 10.27 58 65039 9036 34882798
Immunosuppressant drug level increased 29.96 10.27 46 65051 6009 34885825
Thermophobia 29.50 10.27 9 65088 59 34891775
Lichen planus 29.36 10.27 20 65077 979 34890855
Anal fissure 29.26 10.27 38 65059 4252 34887582
Gastrointestinal haemorrhage 29.25 10.27 77 65020 88400 34803434
Hypophysitis 29.00 10.27 28 65069 2258 34889576
SARS-CoV-2 test negative 28.99 10.27 20 65077 1000 34890834
Product use in unapproved indication 28.78 10.27 340 64757 117159 34774675
Secondary adrenocortical insufficiency 28.70 10.27 23 65074 1447 34890387
Sedation 28.42 10.27 3 65094 21003 34870831
Meningitis tuberculous 28.30 10.27 17 65080 668 34891166
Cardiac failure 28.24 10.27 82 65015 91166 34800668
Hospitalisation 28.02 10.27 39 65058 56863 34834971
Idiopathic intracranial hypertension 27.94 10.27 17 65080 684 34891150
Respiratory disorder 27.76 10.27 89 65008 19175 34872659
Anaphylactic reaction 27.35 10.27 126 64971 32175 34859659
Hypertrophic cardiomyopathy 26.72 10.27 20 65077 1137 34890697
Pituitary haemorrhage 26.62 10.27 11 65086 189 34891645
Anaemia 26.61 10.27 292 64805 233043 34658791
Thyrotoxic periodic paralysis 26.13 10.27 10 65087 139 34891695
Colitis 26.10 10.27 139 64958 37611 34854223
Inflammatory marker increased 26.01 10.27 39 65058 4989 34886845
Skin irritation 25.69 10.27 41 65056 5536 34886298
Chills 25.67 10.27 247 64850 80796 34811038
Multiple organ dysfunction syndrome 25.07 10.27 235 64862 76331 34815503
Transient ischaemic attack 25.06 10.27 10 65087 27603 34864231
Strongyloidiasis 25.02 10.27 28 65069 2683 34889151
Symptom masked 24.25 10.27 15 65082 622 34891212
Meningitis candida 23.92 10.27 8 65089 73 34891761
Lung consolidation 23.80 10.27 41 65056 5895 34885939
Insulin-like growth factor decreased 23.33 10.27 11 65086 262 34891572
Kounis syndrome 23.23 10.27 26 65071 2492 34889342
Rash 22.74 10.27 559 64538 222193 34669641
Weight fluctuation 22.37 10.27 37 65060 5148 34886686
Platelet count decreased 22.35 10.27 131 64966 119586 34772248
Periorbital infection 22.14 10.27 9 65088 148 34891686
Klebsiella infection 22.09 10.27 49 65048 8482 34883352
Feeling cold 22.01 10.27 56 65041 10583 34881251
Cushingoid 21.64 10.27 26 65071 2688 34889146
Pruritus 21.61 10.27 378 64719 141603 34750231
Liver disorder 21.36 10.27 18 65079 32979 34858855
Insulin-like growth factor increased 21.24 10.27 18 65079 1225 34890609
Adrenocorticotropic hormone deficiency 21.05 10.27 16 65081 931 34890903
Body temperature increased 20.44 10.27 75 65022 17293 34874541
Candida infection 20.43 10.27 76 65021 17639 34874195
Growth retardation 20.43 10.27 21 65076 1827 34890007
Renal failure 20.27 10.27 151 64946 130406 34761428
Asthenia 19.93 10.27 329 64768 244922 34646912
Prostate cancer 19.69 10.27 27 65070 39622 34852212
Tooth injury 19.67 10.27 17 65080 1188 34890646
Suicidal ideation 19.56 10.27 28 65069 40360 34851474
Toxic epidermal necrolysis 19.49 10.27 86 65011 21560 34870274
Pneumoretroperitoneum 19.27 10.27 8 65089 139 34891695
Perioral dermatitis 19.22 10.27 8 65089 140 34891694
Hyperbilirubinaemia 19.21 10.27 72 65025 16771 34875063
Shared psychotic disorder 19.06 10.27 5 65092 17 34891817
Haemorrhoids 18.92 10.27 65 65032 14510 34877324
Posturing 18.88 10.27 12 65085 522 34891312
Proctitis 18.78 10.27 23 65074 2426 34889408
Urticaria 18.72 10.27 188 64909 62189 34829645
Neoplasm recurrence 18.68 10.27 22 65075 2227 34889607
Splenic peliosis 18.63 10.27 5 65092 19 34891815
Body height below normal 18.40 10.27 9 65088 233 34891601
Perineal pain 18.35 10.27 14 65083 819 34891015
Pituitary tumour recurrent 18.24 10.27 7 65090 98 34891736
Cryptococcal fungaemia 18.24 10.27 7 65090 98 34891736
Impaired work ability 18.16 10.27 40 65057 6890 34884944
Cardiac disorder 17.98 10.27 33 65064 43093 34848741
Hepatic cirrhosis 17.93 10.27 5 65092 17309 34874525
Disseminated cryptococcosis 17.63 10.27 17 65080 1369 34890465
Lacrimal duct neoplasm 17.53 10.27 5 65092 25 34891809
Mantle cell lymphoma stage III 17.53 10.27 5 65092 25 34891809
Anal fistula 17.48 10.27 34 65063 5365 34886469
Sepsis 17.28 10.27 419 64678 166142 34725692
Pyrexia 17.20 10.27 771 64326 332242 34559592
Pharyngitis streptococcal 17.11 10.27 23 65074 2661 34889173
Neuroleptic malignant syndrome 17.10 10.27 6 65091 17928 34873906
Syncope 17.10 10.27 100 64997 91351 34800483
Cholangitis infective 17.10 10.27 9 65088 273 34891561
White blood cell count decreased 16.99 10.27 106 64991 95339 34796495
Lip swelling 16.91 10.27 67 65030 16013 34875821
Skin lesion 16.66 10.27 83 65014 21878 34869956
Malignant neoplasm progression 16.61 10.27 96 65001 87950 34803884
Rectal haemorrhage 16.57 10.27 130 64967 40119 34851715
Diarrhoea haemorrhagic 16.56 10.27 38 65059 6726 34885108
Arthralgia 16.52 10.27 424 64673 169617 34722217
Drug level increased 16.40 10.27 83 65014 22013 34869821
Optic nerve disorder 16.38 10.27 12 65085 660 34891174
Thyroxine free decreased 16.33 10.27 9 65088 300 34891534
Device dislocation 16.30 10.27 36 65061 6213 34885621
Renal impairment 16.29 10.27 106 64991 94407 34797427
Intentional self-injury 16.21 10.27 3 65094 13768 34878066
Incorrect dose administered 16.20 10.27 130 64967 40385 34851449
Apnoeic attack 16.14 10.27 10 65087 416 34891418
Proctalgia 16.11 10.27 34 65063 5689 34886145
Subdural haematoma 16.07 10.27 9 65088 20412 34871422
Angina pectoris 15.94 10.27 21 65076 31342 34860492
Chronic kidney disease 15.91 10.27 33 65064 41177 34850657
White blood cell count increased 15.84 10.27 33 65064 41118 34850716
Hydrocephalus 15.80 10.27 32 65065 5200 34886634
Neurotoxicity 15.80 10.27 71 65026 17939 34873895
Insomnia 15.73 10.27 121 64976 103786 34788048
Functional gastrointestinal disorder 15.59 10.27 20 65077 2211 34889623
Acute kidney injury 15.51 10.27 441 64656 304547 34587287
Drug ineffective for unapproved indication 15.49 10.27 86 65011 23629 34868205
Cardio-respiratory arrest 15.44 10.27 52 65045 55221 34836613
Unevaluable event 15.38 10.27 23 65074 32567 34859267
Hyperkalaemia 15.13 10.27 72 65025 69317 34822517
Respiratory distress 15.12 10.27 116 64981 35549 34856285
Short stature 15.08 10.27 6 65091 93 34891741
Chest pain 15.08 10.27 157 64940 126605 34765229
Otitis media acute 15.03 10.27 11 65086 604 34891230
Psychotic disorder 15.03 10.27 14 65083 24438 34867396
Optic nerve operation 14.86 10.27 10 65087 480 34891354
Blood creatine phosphokinase increased 14.84 10.27 39 65058 44818 34847016
Tumour lysis syndrome 14.78 10.27 67 65030 16992 34874842
Extrapyramidal disorder 14.75 10.27 3 65094 12877 34878957
Blood corticotrophin increased 14.74 10.27 6 65091 99 34891735
Loss of personal independence in daily activities 14.68 10.27 109 64988 33070 34858764
Perineal infection 14.66 10.27 11 65086 628 34891206
Wrong technique in product usage process 14.59 10.27 28 65069 35958 34855876
Eczema herpeticum 14.57 10.27 7 65090 174 34891660
Rales 14.55 10.27 46 65051 9837 34881997
Myelitis transverse 14.53 10.27 14 65083 1126 34890708
Pallor 14.44 10.27 89 65008 25391 34866443
Morganella infection 14.28 10.27 10 65087 512 34891322
Product quality issue 14.15 10.27 7 65090 17028 34874806
Loss of consciousness 14.10 10.27 93 65004 82574 34809260
Lichenification 14.05 10.27 9 65088 397 34891437
Electrocardiogram QT prolonged 14.02 10.27 35 65062 40917 34850917
Dermatitis diaper 14.00 10.27 8 65089 286 34891548
Pharyngeal paraesthesia 13.98 10.27 11 65086 674 34891160
Anaplastic astrocytoma 13.97 10.27 6 65091 114 34891720
Bacteraemia 13.89 10.27 73 65024 19644 34872190
Pouchitis 13.89 10.27 11 65086 680 34891154
Feeling hot 13.84 10.27 72 65025 19300 34872534
Adrenal insufficiency neonatal 13.79 10.27 3 65094 3 34891831
Bronchial haemorrhage 13.64 10.27 11 65086 698 34891136
Aggression 13.57 10.27 33 65064 38931 34852903
Blood glucose increased 13.54 10.27 71 65026 66647 34825187
Sleep disorder due to a general medical condition 13.53 10.27 30 65067 5191 34886643
Coma 13.44 10.27 42 65055 45636 34846198
Gastric ulcer perforation 13.40 10.27 13 65084 1055 34890779
Depression 13.36 10.27 116 64981 96982 34794852
Vestibular neuronitis 13.34 10.27 7 65090 211 34891623
Hypophosphataemia 13.30 10.27 48 65049 10978 34880856
Skin exfoliation 13.22 10.27 92 65005 27340 34864494
Arm amputation 13.16 10.27 6 65091 132 34891702
Crohn's disease 13.12 10.27 22 65075 3095 34888739
Cryptococcal meningoencephalitis 13.12 10.27 6 65091 133 34891701
Abdominal pain 13.09 10.27 398 64699 163220 34728614
Bladder cancer 13.06 10.27 7 65090 16271 34875563
Tendon disorder 13.06 10.27 21 65076 2854 34888980
Decreased appetite 12.91 10.27 225 64872 166167 34725667
Hyponatraemia 12.87 10.27 221 64876 82470 34809364
Drug specific antibody 12.86 10.27 8 65089 335 34891499
Injection site pain 12.84 10.27 34 65063 38971 34852863
Platelet transfusion 12.80 10.27 15 65082 1511 34890323
Accidental exposure to product 12.70 10.27 4 65093 12798 34879036
Congenital adrenal gland hypoplasia 12.58 10.27 3 65094 6 34891828
Leptotrichia infection 12.54 10.27 5 65092 78 34891756
C-reactive protein increased 12.47 10.27 55 65042 54043 34837791
Contraindicated product administered 12.40 10.27 13 65084 21468 34870366
Cerebral infarction 12.36 10.27 20 65077 27435 34864399
Gonadotrophin deficiency 12.32 10.27 4 65093 33 34891801
Scrotal infection 12.29 10.27 10 65087 643 34891191
Potentiating drug interaction 12.23 10.27 28 65069 4949 34886885
Erythema nodosum 12.19 10.27 14 65083 1380 34890454
Escherichia sepsis 12.16 10.27 27 65070 4677 34887157
Gingival pain 12.13 10.27 21 65076 3031 34888803
Vomiting projectile 12.11 10.27 10 65087 656 34891178
Prothrombin level abnormal 12.04 10.27 5 65092 87 34891747
Hypernatraemia 12.03 10.27 39 65058 8451 34883383
Product prescribing error 12.01 10.27 15 65082 22912 34868922
Renal disorder 12.01 10.27 18 65079 25462 34866372
Staphylococcal sepsis 12.00 10.27 43 65054 9801 34882033
Haematochezia 11.97 10.27 136 64961 46398 34845436
Anal haemorrhage 11.94 10.27 19 65078 2559 34889275
Botulism 11.94 10.27 6 65091 165 34891669
Graft versus host disease 11.90 10.27 45 65052 10524 34881310
Skin papilloma 11.88 10.27 17 65080 2086 34889748
Blood culture positive 11.85 10.27 27 65070 4756 34887078
Type 1 diabetes mellitus 11.64 10.27 25 65072 4233 34887601
Drug level above therapeutic 11.63 10.27 25 65072 4236 34887598
Respiratory depression 11.61 10.27 8 65089 16237 34875597
Multiple sclerosis relapse 11.52 10.27 5 65092 13128 34878706
Depressed level of consciousness 11.50 10.27 41 65056 42800 34849034
Contraindicated product prescribed 11.44 10.27 8 65089 409 34891425
Peptic ulcer haemorrhage 11.43 10.27 9 65088 552 34891282
Jugular vein thrombosis 11.40 10.27 15 65082 1700 34890134
Neuralgia 11.38 10.27 57 65040 15056 34876778
Clostridium difficile infection 11.34 10.27 67 65030 18831 34873003
Epiphysiolysis 11.31 10.27 5 65092 102 34891732
Lower respiratory tract infection 11.31 10.27 99 64998 31538 34860296
Pituitary tumour 11.29 10.27 9 65088 562 34891272
Substance-induced psychotic disorder 11.24 10.27 15 65082 1723 34890111
Dyspnoea exertional 11.23 10.27 42 65055 43237 34848597
Oropharyngeal pain 11.15 10.27 108 64989 35377 34856457
Lactobacillus infection 11.13 10.27 7 65090 299 34891535
Gram stain positive 11.09 10.27 5 65092 107 34891727
Weight decreased 11.09 10.27 417 64680 175884 34715950
Aphthous ulcer 11.08 10.27 27 65070 4968 34886866
Burns second degree 11.01 10.27 12 65085 1117 34890717
Blood pressure diastolic increased 10.97 10.27 27 65070 4998 34886836
Lichenoid keratosis 10.96 10.27 18 65079 2490 34889344
Angina unstable 10.94 10.27 4 65093 11649 34880185
Product dose omission issue 10.92 10.27 157 64940 119554 34772280
Stress 10.87 10.27 95 65002 30252 34861582
Addison's disease 10.87 10.27 3 65094 13 34891821
Chronic sinusitis 10.84 10.27 17 65080 2262 34889572
Blood luteinising hormone decreased 10.76 10.27 5 65092 115 34891719
Peripheral swelling 10.72 10.27 91 65006 76450 34815384
Delirium 10.58 10.27 44 65053 43947 34847887
Dizziness 10.58 10.27 318 64779 218203 34673631
Antibody test abnormal 10.57 10.27 6 65091 212 34891622
Hypersensitivity 10.56 10.27 166 64931 60869 34830965
Leukaemia recurrent 10.54 10.27 14 65083 1601 34890233
Haemoglobin decreased 10.46 10.27 160 64937 120612 34771222
Dizziness exertional 10.44 10.27 6 65091 217 34891617
Catarrh 10.38 10.27 11 65086 991 34890843
Renal salt-wasting syndrome 10.36 10.27 7 65090 338 34891496
Pituitary apoplexy 10.30 10.27 4 65093 58 34891776

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
Intentional product use issue 795.56 9.74 1318 179662 150794 79412614
Infusion related reaction 605.94 9.74 1499 179481 228738 79334670
Completed suicide 520.96 9.74 7 180973 245760 79317648
Pericarditis 450.62 9.74 831 180149 103405 79460003
Rheumatoid factor positive 441.29 9.74 609 180371 59230 79504178
Wound 439.29 9.74 875 180105 115304 79448104
Glossodynia 433.15 9.74 813 180167 102524 79460884
Systemic lupus erythematosus 427.90 9.74 887 180093 120262 79443146
Anti-cyclic citrullinated peptide antibody positive 426.96 9.74 715 180265 82428 79480980
Pemphigus 421.80 9.74 787 180193 98795 79464613
Duodenal ulcer perforation 388.50 9.74 605 180375 65606 79497802
Hand deformity 382.47 9.74 774 180206 103145 79460263
Off label use 382.20 9.74 3425 177555 903790 78659618
Inappropriate schedule of product administration 373.48 9.74 891 180089 132737 79430671
Condition aggravated 367.04 9.74 2162 178818 498962 79064446
Blood pressure fluctuation 364.32 9.74 592 180388 66553 79496855
Toxicity to various agents 361.93 9.74 258 180722 421282 79142126
Helicobacter infection 358.60 9.74 600 180380 69104 79494304
Discomfort 355.82 9.74 842 180138 124775 79438633
Drug abuse 316.46 9.74 12 180968 162679 79400729
Adrenocortical insufficiency acute 306.44 9.74 146 180834 2897 79560511
Product use issue 305.00 9.74 1108 179872 208714 79354694
Rheumatic fever 300.57 9.74 347 180633 28178 79535230
Death 274.47 9.74 545 180435 565969 78997439
Blister 272.69 9.74 738 180242 118738 79444670
Adrenal insufficiency 263.04 9.74 324 180656 28163 79535245
Synovitis 245.76 9.74 827 180153 149907 79413501
Fall 243.13 9.74 461 180519 487168 79076240
Arthropathy 237.06 9.74 911 180069 176200 79387208
Maternal exposure during pregnancy 235.88 9.74 764 180216 135774 79427634
Swelling 229.96 9.74 1038 179942 215673 79347735
Hepatic enzyme increased 212.24 9.74 899 180081 181711 79381697
Swollen joint count increased 212.05 9.74 261 180719 22666 79540742
Alopecia 202.81 9.74 1049 179931 230306 79333102
Hypersensitivity 193.04 9.74 1134 179846 261105 79302303
Abdominal discomfort 186.33 9.74 1087 179893 249640 79313768
Drug level below therapeutic 180.41 9.74 161 180819 9609 79553799
Type 2 diabetes mellitus 178.28 9.74 398 180582 56724 79506684
Hip arthroplasty 173.53 9.74 300 180680 35456 79527952
Blood cholesterol increased 172.12 9.74 498 180482 83222 79480186
Steroid withdrawal syndrome 161.37 9.74 61 180919 660 79562748
Craniopharyngioma 159.41 9.74 52 180928 348 79563060
Drug interaction 157.42 9.74 454 180526 414729 79148679
Secondary immunodeficiency 153.06 9.74 94 180886 3140 79560268
Folliculitis 147.85 9.74 363 180617 55017 79508391
Irritable bowel syndrome 145.47 9.74 388 180592 61853 79501555
Fibromyalgia 134.44 9.74 385 180595 63955 79499453
Intentional overdose 134.34 9.74 37 180943 105923 79457485
Overdose 134.11 9.74 132 180848 184074 79379334
Colitis ulcerative 133.97 9.74 264 180716 34478 79528930
Myocardial infarction 132.84 9.74 133 180847 183996 79379412
Rash 130.05 9.74 1936 179044 576422 78986986
Liver injury 126.37 9.74 347 180633 56267 79507141
Frequent bowel movements 121.89 9.74 231 180749 29308 79534100
Psoriatic arthropathy 116.62 9.74 416 180564 77583 79485825
Knee arthroplasty 113.87 9.74 282 180698 42966 79520442
Muscle injury 112.74 9.74 302 180678 48259 79515149
Heart rate irregular 112.58 9.74 237 180743 32442 79530966
Febrile bone marrow aplasia 112.07 9.74 143 180837 12877 79550531
Febrile neutropenia 111.57 9.74 901 180079 230098 79333310
Interstitial lung disease 110.17 9.74 59 180921 112541 79450867
Deep vein thrombosis postoperative 108.58 9.74 128 180852 10624 79552784
Aplastic anaemia 108.30 9.74 166 180814 17739 79545669
Exposure during pregnancy 106.06 9.74 483 180497 100649 79462759
Drug intolerance 105.06 9.74 987 179993 263132 79300276
Facet joint syndrome 103.44 9.74 128 180852 11174 79552234
Injury 100.60 9.74 395 180585 77101 79486307
Sleep disorder due to general medical condition, insomnia type 100.23 9.74 270 180710 43286 79520122
Acute kidney injury 100.02 9.74 729 180251 518675 79044733
Treatment failure 97.49 9.74 692 180288 169794 79393614
Live birth 97.20 9.74 162 180818 18582 79544826
Anaemia 96.94 9.74 602 180378 444413 79118995
Lip dry 94.74 9.74 144 180836 15274 79548134
Autoimmune disorder 89.41 9.74 146 180834 16466 79546942
Faecal calprotectin increased 88.11 9.74 84 180896 5457 79557951
Lower respiratory tract infection 88.05 9.74 548 180432 128672 79434736
Therapeutic response shortened 87.53 9.74 141 180839 15722 79547686
Peripheral venous disease 87.22 9.74 141 180839 15768 79547640
Steroid dependence 86.76 9.74 61 180919 2569 79560839
Adjustment disorder with depressed mood 86.55 9.74 105 180875 8981 79554427
Weight increased 85.84 9.74 985 179995 276401 79287007
Pituitary tumour benign 85.57 9.74 60 180920 2516 79560892
Body temperature fluctuation 85.10 9.74 70 180910 3737 79559671
Atrial fibrillation 84.29 9.74 204 180776 197682 79365726
Product dose omission issue 82.91 9.74 286 180694 247251 79316157
Leukoencephalopathy 82.74 9.74 96 180884 7833 79555575
Platelet count decreased 82.66 9.74 201 180779 194463 79368945
Suicide attempt 81.79 9.74 43 180937 82889 79480519
Sedation 80.73 9.74 11 180969 51884 79511524
Poor venous access 79.97 9.74 146 180834 18003 79545405
Contraindicated product administered 77.93 9.74 618 180362 156920 79406488
Cardiac failure 77.29 9.74 146 180834 154696 79408712
Heart rate decreased 76.84 9.74 340 180640 69976 79493432
Cardiac failure congestive 75.81 9.74 129 180851 142273 79421135
Human bocavirus infection 75.79 9.74 36 180944 709 79562699
Prescribed overdose 75.57 9.74 223 180757 37660 79525748
Drug level decreased 74.04 9.74 124 180856 14278 79549130
Anti-cyclic citrullinated peptide antibody 73.38 9.74 78 180902 5774 79557634
Diabetes insipidus 73.22 9.74 74 180906 5163 79558245
Secondary adrenocortical insufficiency 72.83 9.74 58 180922 2956 79560452
Mycobacterium chelonae infection 71.95 9.74 53 180927 2403 79561005
Gastrointestinal haemorrhage 71.37 9.74 142 180838 147577 79415831
Anal fissure 70.11 9.74 87 180893 7616 79555792
Coma 68.85 9.74 76 180904 100573 79462835
Drug specific antibody present 68.51 9.74 80 180900 6572 79556836
Syncope 68.04 9.74 196 180784 179253 79384155
Urticaria 67.16 9.74 679 180301 184522 79378886
Bacterial infection 67.10 9.74 189 180791 31091 79532317
Renal impairment 66.91 9.74 163 180817 157620 79405788
Joint swelling 66.91 9.74 972 180008 287674 79275734
White blood cell count decreased 64.08 9.74 216 180764 188072 79375336
Stomatitis 63.15 9.74 558 180422 146199 79417209
Wheezing 62.89 9.74 467 180513 116197 79447211
Injection site pain 62.56 9.74 125 180855 129713 79433695
Septic shock 62.52 9.74 485 180495 122316 79441092
Impaired healing 62.39 9.74 376 180604 87279 79476129
Mucosal inflammation 61.52 9.74 336 180644 75244 79488164
Dislocation of vertebra 60.77 9.74 82 180898 7798 79555610
Hypofibrinogenaemia 60.45 9.74 44 180936 1958 79561450
Haemoglobin decreased 60.19 9.74 279 180701 221840 79341568
Depressed level of consciousness 57.71 9.74 81 180899 96571 79466837
Cortisol decreased 57.25 9.74 44 180936 2128 79561280
Cognitive disorder 57.02 9.74 45 180935 69881 79493527
Breast cancer stage III 56.49 9.74 89 180891 9737 79553671
Hallucination 56.21 9.74 67 180913 85678 79477730
Cardio-respiratory arrest 56.20 9.74 100 180880 108410 79454998
Coronary artery disease 56.13 9.74 40 180940 65434 79497974
Multiple sclerosis relapse 55.78 9.74 18 180962 46515 79516893
Wrong technique in product usage process 54.82 9.74 52 180928 73823 79489585
Adverse event 54.72 9.74 276 180704 59938 79503470
Pseudostroke 54.70 9.74 16 180964 70 79563338
Human herpesvirus 6 infection 54.34 9.74 64 180916 5306 79558102
Nausea 54.20 9.74 1708 179272 955488 78607920
Balance disorder 53.12 9.74 89 180891 98768 79464640
Norovirus test positive 52.50 9.74 27 180953 635 79562773
Adrenal suppression 52.18 9.74 35 180945 1364 79562044
Joint range of motion decreased 51.87 9.74 180 180800 33102 79530306
Suicidal ideation 51.82 9.74 58 180922 76282 79487126
Electrocardiogram QT prolonged 51.75 9.74 78 180902 90308 79473100
Rhinovirus infection 51.32 9.74 76 180904 7877 79555531
Eczema 51.31 9.74 206 180774 40612 79522796
Adverse drug reaction 51.26 9.74 291 180689 66101 79497307
Malignant neoplasm progression 51.20 9.74 149 180831 135841 79427567
Transient ischaemic attack 50.96 9.74 28 180952 52667 79510741
Therapeutic product effect decreased 50.68 9.74 582 180398 163281 79400127
Cerebrovascular accident 50.24 9.74 182 180798 155110 79408298
Blood creatinine increased 49.98 9.74 182 180798 154875 79408533
Grip strength decreased 49.74 9.74 135 180845 21734 79541674
Full blood count abnormal 49.69 9.74 15 180965 40459 79522949
Respiratory arrest 49.55 9.74 35 180945 57515 79505893
Asthenia 48.54 9.74 843 180137 510846 79052562
Parainfluenzae virus infection 48.26 9.74 62 180918 5620 79557788
Thymus hypoplasia 47.89 9.74 29 180951 944 79562464
Pruritus 47.83 9.74 1203 179777 393445 79169963
Renal failure 47.31 9.74 265 180715 200703 79362705
Product use in unapproved indication 46.63 9.74 813 180167 249546 79313862
Pneumonia 46.57 9.74 1142 179838 659104 78904304
Intentional self-injury 45.68 9.74 9 180971 32410 79530998
Hypopituitarism 45.65 9.74 47 180933 3352 79560056
Fluid retention 45.27 9.74 55 180925 69754 79493654
Injection site erythema 45.24 9.74 67 180913 78130 79485278
Cystitis bacterial 45.16 9.74 25 180955 685 79562723
Hospitalisation 45.15 9.74 91 180889 94145 79469263
Impaired quality of life 44.60 9.74 100 180880 14286 79549122
Pseudomonal sepsis 44.23 9.74 62 180918 6112 79557296
X-ray abnormal 44.08 9.74 60 180920 5753 79557655
Ill-defined disorder 43.99 9.74 278 180702 65597 79497811
Neoplasm recurrence 43.94 9.74 51 180929 4163 79559245
Lymphoid tissue hypoplasia 43.93 9.74 27 180953 903 79562505
Intentional product misuse 43.82 9.74 94 180886 95071 79468337
Lower limb fracture 43.79 9.74 134 180846 23081 79540327
Strongyloidiasis 43.73 9.74 49 180931 3849 79559559
Perioral dermatitis 43.64 9.74 20 180960 362 79563046
Drug level above therapeutic 43.38 9.74 74 180906 8649 79554759
Musculoskeletal stiffness 43.18 9.74 596 180384 174412 79388996
Soft tissue mass 42.78 9.74 30 180950 1258 79562150
Flushing 42.38 9.74 344 180636 87924 79475484
Loss of consciousness 41.99 9.74 217 180763 167726 79395682
Leukopenia 41.47 9.74 131 180849 116382 79447026
Bronchitis 41.02 9.74 155 180825 130489 79432919
Hypogonadism 40.68 9.74 33 180947 1727 79561681
Blood glucose increased 40.41 9.74 130 180850 114845 79448563
Cardiac disorder 40.37 9.74 54 180926 65703 79497705
Unevaluable event 40.23 9.74 40 180940 55545 79507863
Female genital tract fistula 39.86 9.74 58 180922 5917 79557491
Incorrect dose administered 39.74 9.74 304 180676 76326 79487082
Bursitis 39.67 9.74 174 180806 35670 79527738
Serotonin syndrome 39.27 9.74 27 180953 45000 79518408
Hepatic function abnormal 39.10 9.74 66 180914 73041 79490367
Blood creatine phosphokinase increased 38.84 9.74 56 180924 66034 79497374
Haematuria 38.83 9.74 60 180920 68776 79494632
Wound infection 38.48 9.74 131 180849 23860 79539548
Chronic kidney disease 37.96 9.74 57 180923 66097 79497311
Therapy cessation 37.74 9.74 19 180961 37543 79525865
Arrhythmia 36.92 9.74 51 180929 61221 79502187
Myalgia 36.86 9.74 258 180722 185383 79378025
Clostridium difficile colitis 36.71 9.74 158 180822 32125 79531283
Hypophysitis 36.24 9.74 46 180934 4120 79559288
Neuroleptic malignant syndrome 36.11 9.74 9 180971 27550 79535858
Lupus vulgaris 35.73 9.74 41 180939 3305 79560103
Night sweats 35.50 9.74 221 180759 51874 79511534
Multimorbidity 35.43 9.74 28 180952 1411 79561997
Chronic sinusitis 35.41 9.74 86 180894 12940 79550468
Oesophageal perforation 35.35 9.74 29 180951 1542 79561866
Disease progression 35.26 9.74 259 180721 184103 79379305
Cerebral infarction 35.26 9.74 31 180949 45645 79517763
Meningitis candida 35.21 9.74 13 180967 131 79563277
Bradycardia 35.11 9.74 173 180807 135384 79428024
Osteonecrosis of jaw 35.01 9.74 28 180952 43198 79520210
Dehydration 34.99 9.74 377 180603 247810 79315598
Eczema herpeticum 34.79 9.74 16 180964 292 79563116
Feeling abnormal 34.76 9.74 215 180765 158984 79404424
Aspartate aminotransferase increased 34.73 9.74 179 180801 138462 79424946
Erythema nodosum 34.58 9.74 51 180929 5266 79558142
Enterobacter infection 34.46 9.74 47 180933 4515 79558893
Breast cancer 34.07 9.74 17 180963 33764 79529644
Salpingo-oophorectomy unilateral 33.86 9.74 22 180958 812 79562596
Hypothalamo-pituitary disorder 33.26 9.74 25 180955 1169 79562239
Accidental exposure to product 32.76 9.74 15 180965 31307 79532101
Melaena 32.54 9.74 55 180925 60835 79502573
Dermatitis atopic 32.41 9.74 71 180909 9985 79553423
Urticaria thermal 32.01 9.74 17 180963 428 79562980
Obesity 31.91 9.74 161 180819 34964 79528444
Injection site swelling 31.78 9.74 36 180944 47096 79516312
Hepatotoxicity 31.69 9.74 42 180938 51310 79512098
Pituitary tumour recurrent 31.51 9.74 13 180967 180 79563228
Agitation 31.50 9.74 118 180862 99597 79463811
Pain in extremity 31.26 9.74 611 180369 363927 79199481
Shared psychotic disorder 31.02 9.74 9 180971 38 79563370
Bladder cancer 30.70 9.74 4 180976 19522 79543886
Liver function test abnormal 30.26 9.74 63 180917 64412 79498996
Herpes zoster 30.16 9.74 109 180871 92974 79470434
Walking aid user 29.75 9.74 69 180911 10079 79553329
Chronic obstructive pulmonary disease 29.72 9.74 97 180883 85322 79478086
Lactic acidosis 29.56 9.74 73 180907 70286 79493122
Lung neoplasm malignant 29.55 9.74 13 180967 27779 79535629
Sleep disorder 29.54 9.74 311 180669 85366 79478042
Proctalgia 29.32 9.74 68 180912 9933 79553475
Anal inflammation 29.29 9.74 25 180955 1405 79562003
Angina pectoris 29.27 9.74 45 180935 51687 79511721
Diverticulitis 28.94 9.74 37 180943 45899 79517509
Pneumatosis intestinalis 28.87 9.74 52 180928 6345 79557063
Rheumatoid nodule 28.84 9.74 3 180977 17435 79545973
Viraemia 28.71 9.74 34 180946 2835 79560573
Renal disorder 28.56 9.74 32 180948 42073 79521335
Dysarthria 28.54 9.74 70 180910 67552 79495856
Pituitary haemorrhage 28.53 9.74 14 180966 297 79563111
C-reactive protein 28.49 9.74 45 180935 4934 79558474
Dyskinesia 28.27 9.74 36 180944 44737 79518671
Perfume sensitivity 28.10 9.74 20 180960 859 79562549
Cataract 28.07 9.74 62 180918 62058 79501350
Thermophobia 27.75 9.74 9 180971 59 79563349
Natural killer-cell leukaemia 27.61 9.74 10 180970 95 79563313
Upper gastrointestinal haemorrhage 27.47 9.74 32 180948 41348 79522060
Product prescribing error 27.30 9.74 37 180943 44776 79518632
Sciatica 27.23 9.74 148 180832 33074 79530334
Alanine aminotransferase increased 27.10 9.74 237 180743 162333 79401075
Insulin-like growth factor increased 27.01 9.74 27 180953 1859 79561549
Hyperkalaemia 26.82 9.74 151 180829 114247 79449161
Extrapyramidal disorder 26.78 9.74 9 180971 22670 79540738
Abscess bacterial 26.72 9.74 19 180961 815 79562593
Hyperadrenocorticism 26.70 9.74 14 180966 343 79563065
Neutrophil count decreased 26.64 9.74 116 180864 93843 79469565
Tremor 26.60 9.74 252 180728 169831 79393577
Depression 26.42 9.74 340 180640 216450 79346958
International normalised ratio increased 26.27 9.74 101 180879 84620 79478788
Epidural lipomatosis 26.24 9.74 22 180958 1206 79562202
Pulmonary arterial hypertension 26.11 9.74 16 180964 28350 79535058
Pneumoretroperitoneum 25.63 9.74 11 180969 169 79563239
Orthostatic hypotension 25.42 9.74 56 180924 56108 79507300
Myelopathy 25.31 9.74 41 180939 4592 79558816
Drug withdrawal syndrome 25.10 9.74 25 180955 34693 79528715
Mitral valve incompetence 25.08 9.74 17 180963 28548 79534860
Mobility decreased 25.01 9.74 403 180577 121772 79441636
Kounis syndrome 24.91 9.74 39 180941 4243 79559165
Respiratory depression 24.86 9.74 16 180964 27614 79535794
Parkinsonism 24.67 9.74 4 180976 16580 79546828
Schizophrenia 24.67 9.74 3 180977 15437 79547971
Blood pressure increased 24.29 9.74 640 180340 210720 79352688
Allergy test positive 24.28 9.74 17 180963 711 79562697
Somnolence 24.14 9.74 389 180591 238592 79324816
Contusion 24.14 9.74 473 180507 148303 79415105
Prostate cancer 24.00 9.74 24 180956 33244 79530164
Normal tension glaucoma 23.97 9.74 8 180972 58 79563350
Catarrh 23.79 9.74 27 180953 2151 79561257
Acute myocardial infarction 23.78 9.74 92 180888 76944 79486464
Dyspnoea exertional 23.78 9.74 109 180871 86964 79476444
White blood cell count increased 23.78 9.74 88 180892 74545 79488863
Fistula 23.76 9.74 74 180906 12866 79550542
Drug ineffective 23.65 9.74 2799 178181 1078114 78485294
Road traffic accident 23.63 9.74 175 180805 43489 79519919
Metastases to bone 23.59 9.74 13 180967 24414 79538994
Candida infection 23.51 9.74 158 180822 38056 79525352
Subdural haematoma 23.47 9.74 22 180958 31412 79531996
Therapy interrupted 23.32 9.74 22 180958 31319 79532089
Thrombosis 23.14 9.74 105 180875 83995 79479413
Poisoning deliberate 23.07 9.74 7 180973 18821 79544587
Oedema peripheral 22.80 9.74 419 180561 251869 79311539
Insulin-like growth factor decreased 22.70 9.74 15 180965 570 79562838
Dyspnoea 22.70 9.74 1657 179323 855368 78708040
Angina unstable 22.44 9.74 5 180975 16522 79546886
Urinary tract infection 22.35 9.74 464 180516 274048 79289360
Anal fistula 22.35 9.74 49 180931 6895 79556513
Bronchopulmonary aspergillosis 22.26 9.74 105 180875 22189 79541219
Vaginal discharge 22.16 9.74 51 180929 7412 79555996
Symptom masked 21.96 9.74 21 180959 1369 79562039
Sinusitis fungal 21.91 9.74 27 180953 2347 79561061
Hypothalamic pituitary adrenal axis suppression 21.87 9.74 12 180968 323 79563085
Bone disorder 21.86 9.74 8 180972 19105 79544303
Rhabdomyolysis 21.62 9.74 141 180839 102990 79460418
Colitis 21.59 9.74 258 180722 73049 79490359
Blood corticotrophin increased 21.48 9.74 10 180970 188 79563220
Proctitis 21.40 9.74 46 180934 6386 79557022
Injection site reaction 21.37 9.74 59 180921 54726 79508682
Aggression 21.31 9.74 53 180927 50905 79512503
Renal injury 21.28 9.74 6 180974 16921 79546487
Burns second degree 21.27 9.74 28 180952 2600 79560808
Growth retardation 21.07 9.74 24 180956 1919 79561489
Hypernatraemia 20.67 9.74 76 180904 14375 79549033
Skin ulcer 20.61 9.74 59 180921 54091 79509317
Herpes simplex oesophagitis 20.55 9.74 12 180968 365 79563043
Gastroenteritis norovirus 20.50 9.74 30 180950 3076 79560332
Metabolic acidosis 20.41 9.74 107 180873 82422 79480986
Thyrotoxic periodic paralysis 20.20 9.74 9 180971 152 79563256
Adrenocorticotropic hormone deficiency 20.15 9.74 20 180960 1365 79562043
Excessive eye blinking 20.15 9.74 22 180958 1679 79561729
Maternal exposure timing unspecified 19.94 9.74 42 180938 5750 79557658
Tendonitis 19.85 9.74 15 180965 23815 79539593
Coronavirus infection 19.85 9.74 49 180931 7448 79555960
Neutropenic sepsis 19.83 9.74 117 180863 26947 79536461
Superinfection 19.81 9.74 38 180942 4864 79558544
Morganella infection 19.68 9.74 18 180962 1109 79562299
Jaundice 19.67 9.74 59 180921 53290 79510118
Atrioventricular block 19.57 9.74 4 180976 14037 79549371
Pituitary infarction 19.56 9.74 7 180973 64 79563344
Delusion 19.53 9.74 11 180969 20412 79542996
Oedema 19.34 9.74 380 180600 119200 79444208
Dizziness 19.33 9.74 987 179993 525454 79037954
Neutropenia 19.30 9.74 501 180479 287209 79276199
Myelosuppression 19.22 9.74 39 180941 40257 79523151
Cardiac arrest 19.13 9.74 275 180705 171821 79391587
Thrombocytopenia 19.12 9.74 457 180523 264802 79298606
Gastrointestinal disorder 18.98 9.74 386 180594 121819 79441589
Psychotic disorder 18.97 9.74 41 180939 41361 79522047
Hyperemesis gravidarum 18.89 9.74 12 180968 426 79562982
Airway peak pressure increased 18.82 9.74 11 180969 335 79563073
C-reactive protein abnormal 18.81 9.74 180 180800 48187 79515221
Femur fracture 18.79 9.74 37 180943 38615 79524793
Metastases to liver 18.68 9.74 22 180958 28292 79535116
General physical health deterioration 18.63 9.74 783 180197 274455 79288953
Hallucination, auditory 18.59 9.74 12 180968 20681 79542727
Ischaemic stroke 18.57 9.74 29 180951 33102 79530306
Urinary retention 18.55 9.74 66 180914 56564 79506844
SARS-CoV-2 test negative 18.49 9.74 19 180961 1352 79562056
Abnormal behaviour 18.46 9.74 34 180946 36387 79527021
Diarrhoea haemorrhagic 18.43 9.74 69 180911 13165 79550243
Cerebral haemorrhage 18.37 9.74 68 180912 57605 79505803
Cholelithiasis 18.18 9.74 60 180920 52604 79510804
Drug eruption 18.13 9.74 46 180934 43889 79519519
Blood potassium increased 18.01 9.74 24 180956 29251 79534157
Blood urea increased 17.96 9.74 54 180926 48736 79514672
Nasopharyngitis 17.81 9.74 725 180255 253156 79310252
Blood alkaline phosphatase increased 17.80 9.74 79 180901 63585 79499823
Peptic ulcer haemorrhage 17.78 9.74 16 180964 965 79562443
Haematoma 17.65 9.74 60 180920 52135 79511273
Splenic peliosis 17.65 9.74 5 180975 19 79563389
Injection site bruising 17.65 9.74 42 180938 40960 79522448
Diarrhoea 17.65 9.74 1740 179240 878749 78684659
Product label confusion 17.49 9.74 20 180960 1606 79561802
Blood potassium decreased 17.47 9.74 51 180929 46461 79516947
Cerebral vasoconstriction 17.39 9.74 19 180961 1451 79561957
Autoimmune nephritis 17.39 9.74 14 180966 725 79562683
Toxic skin eruption 17.36 9.74 15 180965 22278 79541130
Embolism venous 17.30 9.74 33 180947 4206 79559202
Musculoskeletal disorder 17.23 9.74 14 180966 21434 79541974
Rib fracture 17.10 9.74 23 180957 27924 79535484
Epistaxis 17.10 9.74 166 180814 111349 79452059
Tenosynovitis 16.98 9.74 7 180973 15547 79547861
Hepatitis 16.92 9.74 67 180913 55660 79507748
Chorioretinopathy 16.87 9.74 23 180957 2208 79561200
Fear 16.87 9.74 15 180965 21971 79541437
Rash erythematous 16.87 9.74 203 180777 57566 79505842
Hypercalcaemia 16.84 9.74 39 180941 38391 79525017
Aspergillus infection 16.82 9.74 87 180893 19074 79544334
Meningitis tuberculous 16.80 9.74 17 180963 1188 79562220
Unmasking of previously unidentified disease 16.77 9.74 22 180958 2035 79561373
Hypertriglyceridaemia 16.57 9.74 65 180915 12675 79550733
Mastocytosis 16.56 9.74 12 180968 530 79562878
Breast cancer female 16.53 9.74 3 180977 11458 79551950
Myelodysplastic syndrome 16.53 9.74 27 180953 30274 79533134
Hyperhidrosis 16.51 9.74 243 180737 151249 79412159
Pneumonia aspiration 16.46 9.74 87 180893 66880 79496528
Mental status changes 16.45 9.74 87 180893 66872 79496536
Transplant failure 16.38 9.74 34 180946 4607 79558801
Enteritis 16.29 9.74 71 180909 14512 79548896
Ulcer 16.08 9.74 27 180953 29945 79533463
Drug resistance 16.06 9.74 46 180934 42167 79521241
Product quality issue 16.06 9.74 33 180947 33907 79529501
Muscle rigidity 15.95 9.74 13 180967 19869 79543539
Gait inability 15.90 9.74 204 180776 58713 79504695
Underdose 15.89 9.74 32 180948 33119 79530289
Diffuse large B-cell lymphoma 15.85 9.74 4 180976 12145 79551263
Pulmonary hypertension 15.77 9.74 56 180924 48024 79515384
Viral infection 15.71 9.74 158 180822 42858 79520550
Red blood cell count decreased 15.70 9.74 72 180908 57441 79505967
Lichen planus 15.66 9.74 25 180955 2766 79560642
Insomnia 15.64 9.74 430 180550 244740 79318668
Hypertension 15.59 9.74 909 180071 330083 79233325
Eosinophilic oesophagitis 15.58 9.74 12 180968 582 79562826
Disseminated cryptococcosis 15.56 9.74 20 180960 1814 79561594
Blood pressure systolic abnormal 15.50 9.74 10 180970 17237 79546171
Joint effusion 15.44 9.74 11 180969 18003 79545405
Surgery 15.39 9.74 32 180948 32734 79530674
Cerebral microangiopathy 15.29 9.74 9 180971 278 79563130
Arthralgia 15.27 9.74 1501 179479 570302 78993106
Vision blurred 15.26 9.74 160 180820 105738 79457670
Hypoaldosteronism 15.23 9.74 10 180970 376 79563032
Paranoia 15.22 9.74 13 180967 19419 79543989
Gingival pain 15.20 9.74 50 180930 8948 79554460
Therapy non-responder 15.15 9.74 294 180686 92011 79471397
Atrial flutter 15.15 9.74 16 180964 21609 79541799
Hypercholesterolaemia 15.13 9.74 97 180883 22998 79540410
Nodule 15.03 9.74 18 180962 22976 79540432
Blood calcium decreased 15.00 9.74 31 180949 31788 79531620
Seronegative arthritis 14.98 9.74 33 180947 4659 79558749
Mydriasis 14.83 9.74 11 180969 17632 79545776
Gastrooesophageal reflux disease 14.82 9.74 158 180822 104088 79459320
Diabetes mellitus inadequate control 14.81 9.74 20 180960 24244 79539164
Vulvovaginal candidiasis 14.77 9.74 23 180957 2491 79560917
Pharyngeal paraesthesia 14.76 9.74 24 180956 2697 79560711
Right ventricular failure 14.72 9.74 19 180961 23478 79539930
Faecaloma 14.72 9.74 4 180976 11560 79551848
Restlessness 14.69 9.74 55 180925 46437 79516971
Osteomyelitis 14.68 9.74 33 180947 32832 79530576
Pseudohypoaldosteronism 14.67 9.74 5 180975 39 79563369
Osteoarthritis 14.64 9.74 279 180701 87030 79476378
Uveitis 14.49 9.74 76 180904 16754 79546654
Hip fracture 14.48 9.74 30 180950 30731 79532677
Panniculitis 14.45 9.74 5 180975 12366 79551042
Intervertebral disc degeneration 14.39 9.74 9 180971 15776 79547632
Gastric ulcer 14.38 9.74 35 180945 33870 79529538
Antithrombin III 14.30 9.74 6 180974 87 79563321
Death neonatal 14.23 9.74 12 180968 663 79562745
Proteinuria 14.22 9.74 33 180947 32469 79530939
Palmar-plantar erythrodysaesthesia syndrome 14.22 9.74 34 180946 33100 79530308
Carpal tunnel syndrome 14.19 9.74 14 180966 19514 79543894
Renal cancer 14.18 9.74 5 180975 12221 79551187
Skin warm 14.15 9.74 40 180940 6592 79556816
C-reactive protein increased 14.05 9.74 207 180773 128820 79434588
Anger 14.04 9.74 11 180969 17151 79546257
Blood corticotrophin decreased 13.94 9.74 11 180969 553 79562855
Hypoperfusion 13.94 9.74 23 180957 2616 79560792
Apathy 13.91 9.74 6 180974 12971 79550437
Hypomagnesaemia 13.86 9.74 57 180923 46854 79516554
Spondylitis 13.68 9.74 32 180948 4699 79558709
Aphasia 13.67 9.74 57 180923 46675 79516733
Visual acuity reduced 13.65 9.74 29 180951 29440 79533968
Ventricular tachycardia 13.65 9.74 49 180931 41886 79521522
Neurotoxicity 13.64 9.74 123 180857 32395 79531013
Renal salt-wasting syndrome 13.62 9.74 12 180968 704 79562704
Cytomegalovirus chorioretinitis 13.61 9.74 35 180945 5455 79557953
Tessellated fundus 13.58 9.74 5 180975 50 79563358
Nasal polyps 13.55 9.74 42 180938 7285 79556123
Hypokinesia 13.47 9.74 14 180966 19046 79544362
Creatinine renal clearance decreased 13.38 9.74 14 180966 18988 79544420
Visual impairment 13.35 9.74 139 180841 91992 79471416
Cryptococcal fungaemia 13.33 9.74 7 180973 172 79563236
PO2 decreased 13.26 9.74 24 180956 2939 79560469
Metastases to lung 13.22 9.74 13 180967 18150 79545258
Rectal haemorrhage 13.20 9.74 245 180735 76055 79487353
Systemic infection 13.14 9.74 3 180977 9749 79553659
Myelitis transverse 13.13 9.74 19 180961 1928 79561480
Optic nerve operation 13.08 9.74 10 180970 480 79562928
Spinal stenosis 13.08 9.74 10 180970 15781 79547627
Coordination abnormal 13.06 9.74 12 180968 17300 79546108
Atrioventricular block first degree 13.03 9.74 6 180974 12485 79550923
Vaginal flatulence 13.01 9.74 22 180958 2553 79560855
Cardiovascular disorder 13.01 9.74 13 180967 18012 79545396
Haematochezia 13.00 9.74 275 180705 87370 79476038
Posterior reversible encephalopathy syndrome 12.92 9.74 103 180877 26178 79537230
Rotator cuff syndrome 12.90 9.74 8 180972 14087 79549321
Klebsiella infection 12.86 9.74 70 180910 15650 79547758
Pulmonary oedema 12.85 9.74 133 180847 88121 79475287
Deformity 12.85 9.74 3 180977 9602 79553806
Perineal pain 12.83 9.74 14 180966 1068 79562340
Leukocytosis 12.71 9.74 53 180927 43402 79520006
Granulocytopenia 12.71 9.74 5 180975 11426 79551982
Tongue disorder 12.70 9.74 8 180972 13967 79549441
Blood bilirubin increased 12.67 9.74 93 180887 66139 79497269
Plasma cell myeloma 12.64 9.74 70 180910 53189 79510219
Haemorrhoids 12.64 9.74 111 180869 29017 79534391
Haematotoxicity 12.63 9.74 10 180970 15509 79547899
Herpes simplex 12.61 9.74 58 180922 12129 79551279
Incorrect route of product administration 12.61 9.74 128 180852 34801 79528607
Onychomadesis 12.57 9.74 33 180947 5209 79558199
Chest discomfort 12.56 9.74 406 180574 137638 79425770
Hyperaesthesia 12.55 9.74 6 180974 12216 79551192
Product storage error 12.54 9.74 11 180969 16215 79547193
Immunosuppressant drug level increased 12.52 9.74 47 180933 8980 79554428
Thyrotoxic crisis 12.49 9.74 15 180965 1269 79562139
Glucocorticoid deficiency 12.46 9.74 11 180969 647 79562761
Infusion site streaking 12.42 9.74 10 180970 518 79562890
Intracardiac thrombus 12.38 9.74 29 180951 4264 79559144
Vaginal haemorrhage 12.32 9.74 19 180961 21798 79541610
Vaginal abscess 12.32 9.74 9 180971 403 79563005
Bronchiectasis 12.27 9.74 90 180890 22296 79541112
Erythema 12.25 9.74 622 180358 222668 79340740
Oropharyngeal pain 12.23 9.74 330 180650 109023 79454385
Anorectal discomfort 12.21 9.74 26 180954 3585 79559823
Ventricular hypokinesia 12.21 9.74 3 180977 9276 79554132
Mucosal hyperaemia 12.20 9.74 5 180975 68 79563340
Complication associated with device 12.19 9.74 13 180967 17483 79545925
Bacteraemia 12.19 9.74 121 180859 32703 79530705
Cardiac failure chronic 12.17 9.74 5 180975 11130 79552278
Gastric cancer 12.09 9.74 4 180976 10175 79553233
Toxic leukoencephalopathy 12.09 9.74 14 180966 1140 79562268
Lichenification 12.07 9.74 12 180968 821 79562587
Hydrocephalus 12.06 9.74 46 180934 8854 79554554
Sputum increased 12.05 9.74 30 180950 4583 79558825
Blood pressure diastolic decreased 12.02 9.74 113 180867 30103 79533305
Cushing's syndrome 12.01 9.74 13 180967 982 79562426
Injection site mass 11.96 9.74 17 180963 20167 79543241
Agranulocytosis 11.92 9.74 57 180923 44973 79518435
Full blood count decreased 11.92 9.74 27 180953 26792 79536616
Dermatitis diaper 11.92 9.74 8 180972 312 79563096
Pollakiuria 11.88 9.74 44 180936 37273 79526135
Miosis 11.84 9.74 11 180969 15778 79547630
Nail dystrophy 11.82 9.74 13 180967 1000 79562408
Hypotension 11.82 9.74 850 180130 439467 79123941
Abdominal pain 11.79 9.74 1032 179948 388537 79174871
Fistula discharge 11.73 9.74 15 180965 1353 79562055
Aphthous ulcer 11.73 9.74 72 180908 16817 79546591
Cortisol abnormal 11.70 9.74 5 180975 76 79563332
Tuberculosis gastrointestinal 11.68 9.74 10 180970 564 79562844
Pleural effusion 11.67 9.74 246 180734 145016 79418392
Status asthmaticus 11.60 9.74 13 180967 1021 79562387
Pulmonary congestion 11.47 9.74 28 180952 27072 79536336
Basilar artery aneurysm 11.43 9.74 4 180976 34 79563374
Posturing 11.41 9.74 13 180967 1040 79562368
Gonadotrophin deficiency 11.33 9.74 4 180976 35 79563373
Lymphocyte count decreased 11.31 9.74 62 180918 47227 79516181
Dry skin 11.30 9.74 217 180763 67778 79495630
Urinary incontinence 11.30 9.74 51 180929 40858 79522550
Nail disorder 11.24 9.74 55 180925 11797 79551611
Deafness 11.24 9.74 19 180961 21018 79542390
Oesophageal adenocarcinoma recurrent 11.23 9.74 4 180976 36 79563372
Drug-induced liver injury 11.18 9.74 96 180884 66021 79497387
Rhinitis allergic 11.18 9.74 7 180973 12262 79551146
Tooth injury 11.15 9.74 18 180962 2010 79561398
Oxygen saturation abnormal 11.14 9.74 29 180951 4553 79558855
Thyroglossal cyst infection 11.14 9.74 4 180976 37 79563371
Infant irritability 11.13 9.74 3 180977 9 79563399
Scrotal infection 11.12 9.74 10 180970 603 79562805
Diffuse alveolar damage 11.11 9.74 25 180955 3579 79559829
End stage renal disease 11.10 9.74 7 180973 12213 79551195
Eosinophilia 11.09 9.74 59 180921 45286 79518122
Constipation 11.08 9.74 527 180453 282523 79280885
Ocular procedural complication 11.08 9.74 9 180971 472 79562936
Gastrointestinal inflammation 11.07 9.74 40 180940 7504 79555904
Vitamin D increased 11.06 9.74 10 180970 607 79562801
Exposure to SARS-CoV-2 11.05 9.74 18 180962 2026 79561382
PCO2 increased 11.04 9.74 17 180963 1823 79561585
Lacrimation increased 11 9.74 88 180892 22389 79541019
Colorectal cancer 10.99 9.74 3 180977 8644 79554764
Tuberous sclerosis complex 10.99 9.74 5 180975 89 79563319
Cryptococcal meningoencephalitis 10.90 9.74 7 180973 253 79563155
Jaundice cholestatic 10.90 9.74 6 180974 11278 79552130
Mucous stools 10.88 9.74 31 180949 5131 79558277
Enterococcal sepsis 10.85 9.74 21 180959 2705 79560703
Acute myeloid leukaemia 10.79 9.74 35 180945 30850 79532558
Anaplastic astrocytoma 10.79 9.74 6 180974 166 79563242
Device issue 10.71 9.74 29 180951 27079 79536329
Nephrotic syndrome 10.71 9.74 6 180974 11168 79552240
Idiopathic intracranial hypertension 10.67 9.74 23 180957 3199 79560209
Sinus congestion 10.60 9.74 18 180962 19878 79543530
Dysgeusia 10.60 9.74 81 180899 57096 79506312
Blood pressure diastolic abnormal 10.58 9.74 17 180963 19185 79544223
Ligament sprain 10.56 9.74 9 180971 13455 79549953
Perineal infection 10.55 9.74 11 180969 796 79562612
Functional gastrointestinal disorder 10.55 9.74 30 180950 4960 79558448
Eosinophil count increased 10.54 9.74 14 180966 17091 79546317
Multiple organ dysfunction syndrome 10.51 9.74 352 180628 119894 79443514
Renal tubular necrosis 10.50 9.74 26 180954 25013 79538395
Haemorrhagic stroke 10.49 9.74 6 180974 11040 79552368
Fracture 10.48 9.74 21 180959 21780 79541628
Gastric ulcer perforation 10.47 9.74 18 180962 2117 79561291
Cerebellar tumour 10.41 9.74 5 180975 101 79563307
Aborted pregnancy 10.36 9.74 4 180976 46 79563362
Pouchitis 10.36 9.74 12 180968 977 79562431
Dysphagia 10.36 9.74 205 180775 121931 79441477
Lung consolidation 10.33 9.74 44 180936 8903 79554505
Enterovirus infection 10.32 9.74 17 180963 1930 79561478
Apnoeic attack 10.31 9.74 10 180970 664 79562744
Vaccination site inflammation 10.29 9.74 4 180976 47 79563361
Intraocular pressure increased 10.28 9.74 4 180976 9201 79554207
Hypopnoea 10.27 9.74 31 180949 5298 79558110
Akathisia 10.23 9.74 9 180971 13250 79550158
Renal cyst 10.21 9.74 11 180969 14721 79548687
Cardiac failure acute 10.20 9.74 17 180963 18912 79544496
Nail infection 10.19 9.74 19 180961 2380 79561028
Haematemesis 10.18 9.74 73 180907 52191 79511217
Altered state of consciousness 10.18 9.74 58 180922 43764 79519644
Blood culture positive 10.16 9.74 42 180938 8387 79555021
Diaphragm muscle weakness 10.14 9.74 6 180974 187 79563221
Femoral neck fracture 10.10 9.74 5 180975 9979 79553429
Purpura 10.10 9.74 18 180962 19509 79543899
Vertigo 10.10 9.74 104 180876 68978 79494430
Herpes simplex hepatitis 10.10 9.74 9 180971 536 79562872
Muscle spasticity 10.06 9.74 21 180959 21454 79541954
Quadriplegia 10.02 9.74 23 180957 3337 79560071
Drug dependence 10.00 9.74 53 180927 40716 79522692
Urosepsis 9.99 9.74 29 180951 26466 79536942
Glomerular filtration rate decreased 9.98 9.74 23 180957 22679 79540729
Polyp 9.96 9.74 3 180977 8104 79555304
Limb injury 9.95 9.74 34 180946 29494 79533914
Hepatocellular carcinoma 9.94 9.74 4 180976 9017 79554391
Mantle cell lymphoma stage III 9.93 9.74 3 180977 15 79563393
Infantile vomiting 9.93 9.74 3 180977 15 79563393
Abdominal compartment syndrome 9.93 9.74 15 180965 1582 79561826
Lacrimal duct neoplasm 9.93 9.74 3 180977 15 79563393
Colon cancer 9.89 9.74 11 180969 14512 79548896
Substance-induced psychotic disorder 9.89 9.74 23 180957 3366 79560042
Pituitary tumour 9.86 9.74 13 180967 1209 79562199
Ruptured cerebral aneurysm 9.85 9.74 9 180971 554 79562854
Faecal calprotectin abnormal 9.83 9.74 6 180974 198 79563210
Periorbital infection 9.82 9.74 5 180975 115 79563293
Torsade de pointes 9.81 9.74 18 180962 19294 79544114
Skin weeping 9.81 9.74 12 180968 1035 79562373
Growth hormone deficiency 9.79 9.74 8 180972 423 79562985
Conus medullaris syndrome 9.79 9.74 4 180976 54 79563354
Epiphysiolysis 9.75 9.74 5 180975 117 79563291
Abnormal dreams 9.74 9.74 7 180973 11405 79552003

FDA Adverse Event Reporting System (Pediatric)

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
Drug-induced liver injury 57.13 40.65 16 195 58 89523
Aspergillus infection 52.53 40.65 16 195 83 89498
Product use issue 42.22 40.65 16 195 175 89406
Hepatotoxicity 41.76 40.65 14 197 103 89478

Pharmacologic Action:

SourceCodeDescription
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
Cerebral edema indication 2032001
Keratitis indication 5888003 DOID:4677
Berylliosis indication 8247009 DOID:10322
Psoriasis indication 9014002 DOID:8893
Ankylosing spondylitis indication 9631008 DOID:7147
Rheumatic heart disease indication 23685000
Atopic dermatitis indication 24079001 DOID:3310
Inflammatory bowel disease indication 24526004 DOID:0050589
Multiple sclerosis indication 24700007 DOID:2377
Severe adrenal insufficiency indication 24867002
Sarcoidosis indication 31541009 DOID:11335
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Tendinitis indication 34840004 DOID:971
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Angioedema indication 41291007 DOID:1558
Humoral hypercalcemia of malignancy indication 47709007
Articular gout indication 48440001 DOID:13189
Edema of larynx indication 51599000
Nephrotic syndrome indication 52254009 DOID:1184
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Löffler's syndrome indication 64936001 DOID:9503
Pemphigus indication 65172003 DOID:9182
Tenosynovitis indication 67801009 DOID:970
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
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Autoimmune disease indication 85828009
Corneal abrasion indication 85848002
Infection by larvae of Trichinella spiralis indication 88264003
Pruritus ani indication 90446007
Acute lymphoid leukemia indication 91857003 DOID:9952
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009
Non-Hodgkin's lymphoma indication 118601006
Mycosis fungoides indication 118618005
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Transplanted organ rejection indication 213148006
Adrenogenital disorder indication 267395000 DOID:0050811
Eruption of skin indication 271807003 DOID:0050486
Infective blepharitis indication 312219000
Bacterial keratitis indication 314557000
Disorder of eye indication 371405004 DOID:5614
Adrenal cortical hypofunction indication 386584007 DOID:10493
Erythroderma indication 399992009
Autoimmune hemolytic anemia indication 413603009 DOID:718
Synovitis indication 416209007 DOID:2703
Post traumatic osteoarthritis indication 699262001
Inflammatory dermatosis indication 703938007
Transfusion Reaction Urticaria indication
Erythroblastic Anemia indication
Synovitis due to Osteoarthritis indication
Systemic Dermatomyositis indication
Respiratory distress syndrome in the newborn off-label use 46775006
Lichen simplex chronicus off-label use 53891004
Congenital hypoplastic anemia off-label use 88854002 DOID:1339
Pruritus of genital organs off-label use 267802000
Itching of skin off-label use 418363000
Neonatal Bronchopulmonary Dysplasia 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
Cirrhosis of liver contraindication 19943007 DOID:5082
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
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
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Hyperglycemia contraindication 80394007 DOID:4195
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
Ophthalmic herpes simplex contraindication 186542001
Heart block contraindication 233916004
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
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
Vaccinia keratitis contraindication 397552005
Gastric ulcer contraindication 397825006 DOID:10808
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
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
Neo-Cortef with Tetracaine Zoetis Inc. 3
Kymar Ointment Improved Intervet Inc. 4
Kanfosone Ointment Zoetis Inc. 3
Amphoderm Ointment Zoetis Inc. 3
Bacitracin-Neomycin-Polymyxin with Hydrocortisone Acetate Ophthalmic Ointment, Vetropolycin HC Ophthalmic Ointment Dechra, Ltd. 4
Forte Topical Ointment Zoetis Inc. 4
Neo-Cortef Sterile Ointment Zoetis Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.94 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL
Corticosteroid-binding globulin Secreted Ki 7.55 CHEMBL

External reference:

IDSource
4017942 VUID
N0000179154 NUI
D00165 KEGG_DRUG
4017941 VANDF
4017942 VANDF
C0063077 UMLSCUI
CHEBI:17609 CHEBI
CHEBI:17650 CHEBI
CHEMBL1091 ChEMBL_ID
DB14539 DRUGBANK_ID
C021650 MESH_SUPPLEMENTAL_RECORD_UI
3X7931PO74 UNII
5744 PUBCHEM_CID
DB00741 DRUGBANK_ID
27197 RXNORM
2500 MMSL
2749 MMSL
4837 MMSL
4838 MMSL
d00254 MMSL
002147 NDDF
002148 NDDF
16602005 SNOMEDCT_US
396458002 SNOMEDCT_US
79380007 SNOMEDCT_US
C0020268 UMLSCUI
38 INN_ID
5754 PUBCHEM_CID
D006854 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PROCTOFOAMHC HUMAN PRESCRIPTION DRUG LABEL 2 0037-6822 AEROSOL, FOAM 100 mg TOPICAL ANDA 22 sections
PROCTOFOAMHC HUMAN PRESCRIPTION DRUG LABEL 2 0037-6822 AEROSOL, FOAM 100 mg TOPICAL ANDA 22 sections
EPIFOAM HUMAN PRESCRIPTION DRUG LABEL 2 0037-6824 AEROSOL, FOAM 100 mg TOPICAL ANDA 20 sections
Cortifoam HUMAN PRESCRIPTION DRUG LABEL 1 0037-6830 AEROSOL, FOAM 1500 mg TOPICAL NDA 20 sections
Hydrocortisone HUMAN OTC DRUG LABEL 1 0363-0972 CREAM 1 g TOPICAL OTC MONOGRAPH NOT FINAL 15 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0498-0801 CREAM 1 g TOPICAL OTC monograph not final 13 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0498-0801 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Neo Polycin HC HUMAN PRESCRIPTION DRUG LABEL 4 0574-4144 OINTMENT 10 mg OPHTHALMIC ANDA 20 sections
Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0574-7090 SUPPOSITORY 25 mg RECTAL Unapproved drug other 14 sections
Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0574-7093 SUPPOSITORY 30 mg RECTAL Unapproved drug other 14 sections
Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0493 SUPPOSITORY 30 mg RECTAL Unapproved drug other 14 sections
ANUCORT-HC HUMAN PRESCRIPTION DRUG LABEL 1 0713-0503 SUPPOSITORY 25 mg RECTAL unapproved drug other 14 sections
ANUCORT-HC HUMAN PRESCRIPTION DRUG LABEL 1 0713-0503 SUPPOSITORY 25 mg RECTAL unapproved drug other 14 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0924-5632 OINTMENT 1 g TOPICAL OTC monograph not final 13 sections
Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 10135-751 SUPPOSITORY 25 mg RECTAL unapproved drug other 12 sections
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula HUMAN OTC DRUG LABEL 1 11509-5101 CREAM 280 mg TOPICAL OTC MONOGRAPH NOT FINAL 11 sections
Hydrocortisone HUMAN OTC DRUG LABEL 1 11822-2069 CREAM 1 g TOPICAL OTC MONOGRAPH NOT FINAL 15 sections
Lidocaine Hydrochloride and Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 2 13925-157 CREAM 5 mg RECTAL unapproved drug other 22 sections
Lidocaine Hydrochloride and Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 2 13925-160 CREAM 5 mg TOPICAL unapproved drug other 19 sections
Lidocaine Hydrochloride and Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 2 13925-163 CREAM 10 mg RECTAL unapproved drug other 22 sections
Lidocaine Hydrochloride and Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 2 13925-164 GEL 25 mg RECTAL unapproved drug other 20 sections
Lidocaine Hydrochloride and Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 2 13925-165 CREAM 5 mg RECTAL unapproved drug other 22 sections
NuCort HUMAN PRESCRIPTION DRUG LABEL 1 15014-185 LOTION 20 mg TOPICAL unapproved drug other 20 sections
Hemmorex-HC HUMAN PRESCRIPTION DRUG LABEL 1 16477-201 SUPPOSITORY 25 mg RECTAL unapproved drug other 14 sections
Hemmorex-HC HUMAN PRESCRIPTION DRUG LABEL 1 16477-202 SUPPOSITORY 30 mg RECTAL unapproved drug other 15 sections
Hydrocortisone Acetate Human Prescription Drug Label 1 16571-676 SUPPOSITORY 25 mg RECTAL UNAPPROVED DRUG OTHER 14 sections
Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 1 21695-731 SUPPOSITORY 30 mg RECTAL Unapproved drug other 12 sections
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate HUMAN PRESCRIPTION DRUG LABEL 4 21695-736 OINTMENT 10 mg OPHTHALMIC ANDA 18 sections
ProctofoamHC HUMAN PRESCRIPTION DRUG LABEL 2 21695-982 AEROSOL, FOAM 100 mg TOPICAL ANDA 23 sections
Hydrocortisoneacetatesuppository HUMAN PRESCRIPTION DRUG LABEL 1 24689-102 SUPPOSITORY 25 mg RECTAL unapproved drug other 16 sections