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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.23 mg/mL Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose) 353.81 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.20 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.60 hours Lombardo F, Berellini G, Obach RS

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Infusion related reaction 600.87 9.84 2010 212648 243511 63030853
Pericarditis 598.73 9.84 1353 213305 130226 63144138
Anti-cyclic citrullinated peptide antibody positive 568.20 9.84 1230 213428 114982 63159382
Rheumatoid factor positive 531.73 9.84 993 213665 83413 63190951
Wound 521.83 9.84 1468 213190 161795 63112569
Duodenal ulcer perforation 489.39 9.84 977 213681 86232 63188132
Discomfort 479.21 9.84 1447 213211 165927 63108437
Helicobacter infection 472.94 9.84 999 213659 91786 63182578
Completed suicide 456.30 9.84 7 214651 145666 63128698
Hand deformity 440.95 9.84 1362 213296 158095 63116269
Intentional product use issue 418.34 9.84 1160 213498 126732 63147632
Glossodynia 393.23 9.84 1414 213244 177462 63096902
Synovitis 371.17 9.84 1430 213228 185488 63088876
Rheumatic fever 364.46 9.84 578 214080 42533 63231831
Hepatic enzyme increased 353.16 9.84 1487 213171 200841 63073523
Systemic lupus erythematosus 348.91 9.84 1515 213143 207403 63066961
Toxicity to various agents 348.00 9.84 202 214456 247048 63027316
Pemphigus 342.46 9.84 1378 213280 182348 63092016
Adrenocortical insufficiency acute 306.57 9.84 138 214520 1560 63272804
Swollen joint count increased 285.11 9.84 469 214189 35585 63238779
Death 283.60 9.84 521 214137 373860 62900504
Blister 276.46 9.84 1016 213642 128798 63145566
Arthropathy 272.31 9.84 1535 213123 233257 63041107
Type 2 diabetes mellitus 266.28 9.84 635 214023 63233 63211131
Swelling 255.95 9.84 1700 212958 273678 63000686
Hypersensitivity 239.17 9.84 1751 212907 290934 62983430
Blood cholesterol increased 237.56 9.84 779 213879 93253 63181111
Product use issue 218.01 9.84 1383 213275 219137 63055227
Abdominal discomfort 217.19 9.84 1838 212820 319047 62955317
Fall 216.06 9.84 647 214011 391687 62882677
Drug abuse 194.13 9.84 13 214645 72505 63201859
Drug intolerance 191.68 9.84 1735 212923 306926 62967438
Folliculitis 188.88 9.84 595 214063 69722 63204642
Irritable bowel syndrome 185.53 9.84 657 214001 81755 63192609
Alopecia 182.24 9.84 1842 212816 335694 62938670
Condition aggravated 181.20 9.84 2117 212541 400100 62874264
Injury 178.00 9.84 599 214059 72648 63201716
Drug interaction 171.37 9.84 321 214337 228810 63045554
Maternal exposure during pregnancy 164.63 9.84 1290 213368 218772 63055592
Muscle injury 163.77 9.84 540 214118 64805 63209559
Intentional overdose 161.45 9.84 28 214630 74124 63200240
Steroid withdrawal syndrome 161.36 9.84 63 214595 482 63273882
Overdose 152.06 9.84 101 214557 114977 63159387
Adrenal insufficiency 151.08 9.84 240 214418 17675 63256689
Hip arthroplasty 149.53 9.84 426 214232 47220 63227144
Drug hypersensitivity 145.91 9.84 1649 213009 309038 62965326
Colitis ulcerative 138.71 9.84 286 214372 25805 63248559
Fibromyalgia 136.11 9.84 586 214072 79834 63194530
Sleep disorder due to general medical condition, insomnia type 134.87 9.84 436 214222 51781 63222583
Treatment failure 126 9.84 1124 213534 197919 63076445
Rash 125.47 9.84 2623 212035 558248 62716116
Product dose omission issue 118.55 9.84 401 214257 233912 63040452
Acute kidney injury 116.80 9.84 476 214182 262939 63011425
Liver injury 108.62 9.84 449 214209 60071 63214293
Contraindicated product administered 107.92 9.84 1168 213490 216480 63057884
Knee arthroplasty 105.95 9.84 413 214245 53793 63220571
Therapeutic product effect decreased 105.34 9.84 1057 213601 192130 63082234
Deep vein thrombosis postoperative 103.81 9.84 158 214500 11211 63263153
Impaired healing 98.62 9.84 639 214019 101903 63172461
Prescribed overdose 97.24 9.84 295 214363 33858 63240506
Joint swelling 96.92 9.84 1601 213057 326065 62948299
Suicide attempt 92.58 9.84 45 214613 60873 63213491
Inappropriate schedule of product administration 91.64 9.84 634 214024 103331 63171033
Craniopharyngioma 91.38 9.84 30 214628 128 63274236
Frequent bowel movements 89.60 9.84 223 214435 22799 63251565
Off label use 88.62 9.84 2941 211717 671521 62602843
Lip dry 87.48 9.84 174 214484 15296 63259068
Blood pressure fluctuation 85.77 9.84 347 214311 45970 63228394
Facet joint syndrome 84.19 9.84 149 214509 11989 63262375
Device expulsion 83.41 9.84 10 214648 34912 63239452
Autoimmune disorder 82.86 9.84 181 214477 16996 63257368
Febrile bone marrow aplasia 80.29 9.84 111 214547 7214 63267150
Anaemia 79.55 9.84 623 214035 292807 62981557
Sedation 77.49 9.84 18 214640 38791 63235573
General physical health deterioration 77.06 9.84 1029 213629 200373 63073991
Adverse event 76.99 9.84 440 214218 67119 63207245
Adjustment disorder with depressed mood 76.98 9.84 130 214528 10074 63264290
Live birth 76.39 9.84 225 214433 25405 63248959
Mobility decreased 73.94 9.84 679 213979 120480 63153884
Musculoskeletal stiffness 73.44 9.84 950 213708 183668 63090696
Hypofibrinogenaemia 73.28 9.84 47 214611 1123 63273241
Lower respiratory tract infection 73.08 9.84 726 213932 131581 63142783
Psoriatic arthropathy 72.49 9.84 544 214114 90976 63183388
Cognitive disorder 72.35 9.84 50 214608 55765 63218599
Lupus vulgaris 70.51 9.84 94 214564 5900 63268464
Cerebrovascular accident 69.22 9.84 165 214493 107859 63166505
Cardiac failure congestive 68.57 9.84 130 214528 92303 63182061
Atrial fibrillation 67.92 9.84 187 214471 116449 63157915
Drug tolerance decreased 67.73 9.84 169 214489 17304 63257060
Myocardial infarction 67.72 9.84 148 214510 99745 63174619
Renal impairment 67.55 9.84 122 214536 88233 63186131
X-ray abnormal 67.49 9.84 108 214550 8002 63266362
Secondary adrenocortical insufficiency 67.08 9.84 48 214610 1380 63272984
Malignant neoplasm progression 66.80 9.84 109 214549 82012 63192352
Nausea 66.57 9.84 2295 212363 852176 62422188
Haemoglobin decreased 66.25 9.84 260 214398 145225 63129139
Drug level below therapeutic 66.18 9.84 82 214576 4784 63269580
Female genital tract fistula 66.13 9.84 103 214555 7456 63266908
Syncope 65.56 9.84 192 214466 117193 63157171
Pituitary tumour benign 65.08 9.84 54 214604 1941 63272423
Interstitial lung disease 64.91 9.84 68 214590 61840 63212524
Platelet count decreased 64.81 9.84 190 214468 115932 63158432
Anti-cyclic citrullinated peptide antibody 64.66 9.84 96 214562 6662 63267702
Neutropenia 64.58 9.84 338 214320 174667 63099697
Peripheral venous disease 64.58 9.84 154 214504 15323 63259041
Coma 63.84 9.84 74 214584 64290 63210074
Wheezing 63.08 9.84 545 214113 95050 63179314
Ill-defined disorder 61.97 9.84 481 214177 81274 63193090
Dislocation of vertebra 61.18 9.84 107 214551 8528 63265836
Full blood count abnormal 60.82 9.84 16 214642 31701 63242663
Balance disorder 60.65 9.84 121 214537 84301 63190063
White blood cell count decreased 59.33 9.84 255 214403 138849 63135515
Injection site pain 57.18 9.84 235 214423 129565 63144799
Wrong technique in product usage process 56.28 9.84 77 214581 62263 63212101
Serotonin syndrome 55.90 9.84 14 214644 28668 63245696
Gastrointestinal haemorrhage 55.24 9.84 120 214538 81056 63193308
Cardio-respiratory arrest 55.20 9.84 73 214585 59886 63214478
Disease progression 54.86 9.84 221 214437 122537 63151827
Injection site erythema 54.11 9.84 126 214532 83048 63191316
Depressed level of consciousness 53.74 9.84 79 214579 61999 63212365
Intentional self-injury 53.13 9.84 11 214647 25676 63248688
Cardiac failure 52.58 9.84 142 214516 89000 63185364
Stomatitis 51.47 9.84 705 213953 138020 63136344
Somnolence 50.91 9.84 374 214284 178311 63096053
Breast cancer 50.88 9.84 53 214605 48330 63226034
Electrocardiogram QT prolonged 50.32 9.84 77 214581 59453 63214911
Blood creatinine increased 49.54 9.84 143 214515 87701 63186663
Chronic obstructive pulmonary disease 49.32 9.84 85 214573 62601 63211763
Suicidal ideation 48.78 9.84 85 214573 62336 63212028
Rheumatoid arthritis 48.41 9.84 587 214071 253232 63021132
Adverse drug reaction 48.24 9.84 446 214212 79268 63195096
Pneumonia 47.68 9.84 1178 213480 455589 62818775
Breast cancer stage III 47.35 9.84 107 214551 10279 63264085
Tremor 47.33 9.84 258 214400 131981 63142383
Respiratory arrest 46.80 9.84 26 214632 32619 63241745
Joint range of motion decreased 44.29 9.84 222 214436 32206 63242158
Hyperadrenocorticism 43.31 9.84 22 214636 331 63274033
Intentional product misuse 43.16 9.84 88 214570 60829 63213535
Urticaria 43.11 9.84 794 213864 165008 63109356
Bradycardia 42.92 9.84 117 214541 73110 63201254
Hypercholesterolaemia 42.86 9.84 164 214494 21170 63253194
Product use in unapproved indication 42.60 9.84 846 213812 178234 63096130
Weight increased 42.60 9.84 1169 213489 259623 63014741
Cardiac arrest 41.09 9.84 167 214491 92378 63181986
Loss of consciousness 40.88 9.84 233 214425 117888 63156476
Injection site swelling 40.72 9.84 61 214597 47511 63226853
Pulmonary fibrosis 40.67 9.84 252 214406 39557 63234807
Hypotension 40.10 9.84 664 213994 271940 63002424
Cardiac disorder 39.89 9.84 69 214589 50747 63223617
Grip strength decreased 39.69 9.84 165 214493 22122 63252242
Hypertension 39.60 9.84 1230 213428 278073 62996291
Poor venous access 39.57 9.84 125 214533 14660 63259704
Hospitalisation 39.39 9.84 151 214507 84930 63189434
Wound infection 39.31 9.84 160 214498 21250 63253114
Contusion 39.16 9.84 719 213939 149325 63125039
Thrombocytopenia 39.03 9.84 325 214333 150832 63123532
Prescribed underdose 38.97 9.84 201 214457 29488 63244876
Adrenal suppression 38.74 9.84 29 214629 895 63273469
Blood creatine phosphokinase increased 38.46 9.84 28 214630 30402 63243962
Dehydration 37.33 9.84 390 214268 172964 63101400
Faecal calprotectin increased 37.32 9.84 50 214608 3153 63271211
Femur fracture 37.26 9.84 52 214606 41704 63232660
Cortisol decreased 37.14 9.84 32 214626 1212 63273152
Lactic acidosis 36.92 9.84 45 214613 38242 63236122
Lower limb fracture 36.81 9.84 171 214487 24050 63250314
Gastrointestinal disorder 36.77 9.84 636 214022 130603 63143761
Anal fissure 36.74 9.84 59 214599 4384 63269980
Feeling abnormal 36.55 9.84 323 214335 148069 63126295
Orthostatic hypotension 36.48 9.84 41 214617 36119 63238245
Accidental exposure to product 36.25 9.84 24 214634 27381 63246983
Vaginal flatulence 36.24 9.84 50 214608 3243 63271121
Therapy cessation 35.99 9.84 30 214628 30427 63243937
Leukopenia 35.89 9.84 137 214521 77153 63197211
Vaginal discharge 35.69 9.84 89 214569 9109 63265255
Musculoskeletal injury 35.43 9.84 14 214644 111 63274253
Multiple sclerosis relapse 35.23 9.84 69 214589 48409 63225955
Arthralgia 35.18 9.84 2304 212354 567406 62706958
Renal failure 35.08 9.84 243 214415 117409 63156955
Bronchitis 34.85 9.84 263 214395 124672 63149692
Human bocavirus infection 34.63 9.84 20 214638 393 63273971
Blepharospasm 34.57 9.84 68 214590 5928 63268436
Melaena 34.56 9.84 31 214627 30334 63244030
Maternal exposure timing unspecified 34.55 9.84 75 214583 7012 63267352
Hepatic function abnormal 34.41 9.84 45 214613 37097 63237267
Drug withdrawal syndrome 34.40 9.84 25 214633 27169 63247195
Metastases to bone 34.33 9.84 14 214644 21005 63253359
Red blood cell sedimentation rate abnormal 34.27 9.84 12 214646 19770 63254594
Therapeutic response shortened 34.13 9.84 103 214555 11785 63262579
C-reactive protein 33.95 9.84 60 214598 4822 63269542
Injection site reaction 33.93 9.84 94 214564 58430 63215934
Pleural effusion 33.82 9.84 181 214477 93029 63181335
Hypothalamic pituitary adrenal axis suppression 33.68 9.84 15 214643 165 63274199
Proctitis 32.95 9.84 63 214595 5378 63268986
Herpes zoster 32.84 9.84 155 214503 82307 63192057
Seizure 32.53 9.84 289 214369 132345 63142019
Hyperhidrosis 32.51 9.84 222 214436 107614 63166750
Rhabdomyolysis 32.42 9.84 62 214596 43889 63230475
Hypothalamo-pituitary disorder 32.39 9.84 24 214634 729 63273635
Alanine aminotransferase increased 32.10 9.84 212 214446 103558 63170806
Migraine 31.95 9.84 509 214149 102837 63171527
Osteonecrosis of jaw 31.08 9.84 44 214614 35079 63239285
Unevaluable event 30.95 9.84 81 214577 51305 63223059
Acute myocardial infarction 30.72 9.84 38 214620 32086 63242278
Therapy interrupted 30.40 9.84 39 214619 32416 63241948
Creatinine renal clearance decreased 29.83 9.84 9 214649 16299 63258065
Hepatotoxicity 29.34 9.84 50 214608 36991 63237373
Eczema 29.06 9.84 198 214460 32093 63242271
Liver function test abnormal 28.98 9.84 76 214582 48105 63226259
Fistula 28.86 9.84 89 214569 10304 63264060
Perfume sensitivity 28.81 9.84 23 214635 782 63273582
Body temperature fluctuation 28.68 9.84 37 214621 2248 63272116
Insulin-like growth factor increased 28.17 9.84 24 214634 895 63273469
Aspartate aminotransferase increased 28.14 9.84 184 214474 90093 63184271
Drug level decreased 28.01 9.84 74 214584 7845 63266519
Night sweats 27.97 9.84 270 214388 48544 63225820
Abortion spontaneous 27.96 9.84 75 214583 47120 63227244
Asthenia 27.71 9.84 1039 213619 382565 62891799
Nasopharyngitis 27.60 9.84 1086 213572 253171 63021193
Neuroleptic malignant syndrome 27.48 9.84 4 214654 12052 63262312
Skin ulcer 27.36 9.84 66 214592 42979 63231385
Hypopituitarism 27.33 9.84 26 214632 1122 63273242
Haematochezia 27.24 9.84 289 214369 53255 63221109
Myelosuppression 27.21 9.84 24 214634 23679 63250685
Pruritus 27.00 9.84 1487 213171 359966 62914398
Fluid retention 26.94 9.84 107 214551 59579 63214785
Oedema peripheral 26.74 9.84 465 214193 189046 63085318
Obesity 26.57 9.84 183 214475 29769 63244595
Dry eye 26.30 9.84 62 214596 40699 63233665
Plasma cell myeloma 26.18 9.84 51 214607 35854 63238510
Steroid dependence 26.06 9.84 31 214627 1733 63272631
Urticaria thermal 25.94 9.84 17 214641 422 63273942
Oedema 25.88 9.84 469 214189 97153 63177211
International normalised ratio increased 25.86 9.84 76 214582 46349 63228015
Agitation 25.79 9.84 109 214549 59648 63214716
Rhinovirus infection 25.68 9.84 51 214607 4478 63269886
Mucous stools 25.50 9.84 49 214609 4199 63270165
Arrhythmia 25.43 9.84 57 214601 38083 63236281
Insulin-like growth factor decreased 25.03 9.84 16 214642 380 63273984
Device dislocation 25.01 9.84 30 214628 25675 63248689
Salpingo-oophorectomy unilateral 24.97 9.84 22 214636 859 63273505
Chronic kidney disease 24.79 9.84 75 214583 45323 63229041
Drug level above therapeutic 24.75 9.84 52 214606 4753 63269611
Neoplasm recurrence 24.56 9.84 37 214621 2601 63271763
Blood glucose increased 24.47 9.84 174 214484 83582 63190782
Normal tension glaucoma 24.39 9.84 8 214650 34 63274330
Gait inability 24.27 9.84 280 214378 52679 63221685
Herpes simplex oesophagitis 24.08 9.84 12 214646 173 63274191
Dizziness 24.07 9.84 1198 213460 428727 62845637
Natural killer-cell leukaemia 23.92 9.84 10 214648 93 63274271
Ascites 23.92 9.84 65 214593 40663 63233701
Thrombosis 23.90 9.84 125 214533 64630 63209734
Renal disorder 23.90 9.84 47 214611 32927 63241437
Sciatica 23.85 9.84 198 214460 34126 63240238
Dyskinesia 23.73 9.84 45 214613 31957 63242407
Complication associated with device 23.65 9.84 14 214644 16964 63257400
Heart rate irregular 23.57 9.84 143 214515 22278 63252086
Pulmonary hypertension 23.53 9.84 57 214601 37066 63237298
Sleep disorder 23.46 9.84 397 214261 81169 63193195
Pulmonary arterial hypertension 23.43 9.84 25 214633 22552 63251812
Drug eruption 23.41 9.84 38 214620 28656 63245708
Hypophysitis 23.41 9.84 30 214628 1811 63272553
Diabetes insipidus 23.29 9.84 36 214622 2589 63271775
Transient ischaemic attack 23.12 9.84 59 214599 37694 63236670
Blood parathyroid hormone decreased 22.90 9.84 3 214655 9788 63264576
Rheumatoid nodule 22.72 9.84 15 214643 17140 63257224
Hypercalcaemia 22.64 9.84 38 214620 28284 63246080
Anal fistula 22.60 9.84 42 214616 3509 63270855
Perioral dermatitis 22.58 9.84 13 214645 254 63274110
Exposure during pregnancy 22.54 9.84 687 213971 154860 63119504
Musculoskeletal disorder 22.40 9.84 22 214636 20622 63253742
Radiculopathy 22.31 9.84 72 214586 8539 63265825
Dysarthria 22.31 9.84 72 214586 42639 63231725
Dermatitis atopic 22.27 9.84 78 214580 9646 63264718
Antithrombin III 22.23 9.84 11 214647 156 63274208
Breast cancer female 22.19 9.84 9 214649 13550 63260814
Walking aid user 22.03 9.84 83 214575 10634 63263730
Tendon pain 22.00 9.84 40 214618 3286 63271078
Basal cell carcinoma 21.97 9.84 38 214620 27953 63246411
Hallucination 21.85 9.84 103 214555 54714 63219650
Constipation 21.84 9.84 586 214072 224357 63050007
Vision blurred 21.79 9.84 202 214456 91722 63182642
Bursitis 21.77 9.84 206 214452 36835 63237529
Device difficult to use 21.76 9.84 8 214650 12788 63261576
Faecal volume decreased 21.62 9.84 11 214647 166 63274198
Blood calcium decreased 21.60 9.84 35 214623 26416 63247948
Colitis 21.53 9.84 255 214403 48273 63226091
Neoplasm progression 21.50 9.84 58 214600 36370 63237994
Product prescribing error 21.27 9.84 35 214623 26254 63248110
Product quality issue 21.24 9.84 57 214601 35808 63238556
Schizophrenia 21.13 9.84 4 214654 9948 63264416
Cataract 21.13 9.84 110 214548 56943 63217421
Coronary artery disease 21.09 9.84 49 214609 32328 63242036
Poisoning deliberate 20.87 9.84 6 214652 11212 63263152
Abdominal pain upper 20.83 9.84 875 213783 205569 63068795
Metastases to liver 20.53 9.84 30 214628 23609 63250755
Proctalgia 20.51 9.84 56 214602 6054 63268310
Haematuria 19.91 9.84 43 214615 29114 63245250
Aphasia 19.88 9.84 52 214606 32948 63241416
Epistaxis 19.85 9.84 154 214504 72571 63201793
Excessive eye blinking 19.75 9.84 23 214635 1257 63273107
Vertigo 19.72 9.84 120 214538 59767 63214597
Respiratory failure 19.60 9.84 235 214423 101623 63172741
Metabolic acidosis 19.58 9.84 82 214576 44987 63229377
Panniculitis 19.56 9.84 7 214651 11378 63262986
Respiratory depression 19.55 9.84 11 214647 13704 63260660
Pancytopenia 19.29 9.84 222 214436 96711 63177653
Palmar-plantar erythrodysaesthesia syndrome 19.23 9.84 30 214628 22985 63251379
Adrenal disorder 19.03 9.84 26 214632 1671 63272693
Lung neoplasm malignant 19.01 9.84 23 214635 19610 63254754
Hypoaesthesia 18.90 9.84 722 213936 167671 63106693
Toxic skin eruption 18.85 9.84 10 214648 12875 63261489
Airway peak pressure increased 18.85 9.84 12 214646 283 63274081
Granuloma skin 18.77 9.84 3 214655 8434 63265930
Road traffic accident 18.76 9.84 198 214460 36434 63237930
Diaphragm muscle weakness 18.58 9.84 6 214652 24 63274340
Therapeutic product effect incomplete 18.56 9.84 304 214354 124752 63149612
Strongyloidiasis 18.55 9.84 22 214636 1226 63273138
Secondary immunodeficiency 18.32 9.84 23 214635 1360 63273004
Hypomagnesaemia 18.31 9.84 44 214614 28693 63245671
Myoclonus 18.30 9.84 16 214642 15852 63258512
Pneumonia aspiration 18.20 9.84 58 214600 34482 63239882
Asphyxia 18.16 9.84 54 214604 6127 63268237
Hypertensive crisis 18.13 9.84 15 214643 15271 63259093
Drug resistance 18.12 9.84 31 214627 22902 63251462
Meningitis candida 18.11 9.84 7 214651 52 63274312
Gastroenteritis norovirus 17.84 9.84 28 214630 2040 63272324
Injection site bruising 17.75 9.84 77 214581 41833 63232531
Myalgia 17.75 9.84 369 214289 146160 63128204
Joint effusion 17.59 9.84 19 214639 17041 63257323
Neutrophil count decreased 17.55 9.84 115 214543 56291 63218073
Diarrhoea 17.52 9.84 2135 212523 713231 62561133
Sinusitis fungal 17.50 9.84 26 214632 1805 63272559
Product storage error 17.34 9.84 15 214643 14941 63259423
Osteopenia 17.29 9.84 25 214633 19760 63254604
Injection site pruritus 17.27 9.84 86 214572 45030 63229334
Skin fragility 17.22 9.84 16 214642 670 63273694
Back pain 17.19 9.84 724 213934 263421 63010943
Dystonia 17.09 9.84 13 214645 13806 63260558
Tenosynovitis 17.04 9.84 13 214645 13782 63260582
Parkinsonism 16.97 9.84 7 214651 10432 63263932
Blood alkaline phosphatase increased 16.97 9.84 81 214577 42886 63231478
Myelodysplastic syndrome 16.89 9.84 19 214639 16735 63257629
Anticipatory anxiety 16.88 9.84 21 214637 1230 63273134
Pseudohypoaldosteronism 16.84 9.84 5 214653 14 63274350
Hypophagia 16.81 9.84 52 214606 31207 63243157
Dysphagia 16.81 9.84 205 214453 88380 63185984
Palpitations 16.78 9.84 274 214384 112496 63161868
Hypogonadism 16.72 9.84 8 214650 105 63274259
Bone disorder 16.70 9.84 29 214629 21297 63253067
Clostridium difficile colitis 16.69 9.84 123 214535 20446 63253918
Gastrointestinal toxicity 16.68 9.84 3 214655 7738 63266626
Allergy test positive 16.62 9.84 15 214643 605 63273759
Urinary retention 16.59 9.84 50 214608 30251 63244113
Eczema herpeticum 16.38 9.84 9 214649 160 63274204
No adverse event 16.38 9.84 78 214580 41327 63233037
Dyspepsia 16.34 9.84 457 214201 101739 63172625
Natural killer cell count decreased 16.33 9.84 6 214652 38 63274326
Hepatitis 16.31 9.84 74 214584 39714 63234650
Upper gastrointestinal haemorrhage 16.30 9.84 24 214634 18828 63255536
Hyponatraemia 16.28 9.84 273 214385 111627 63162737
Loss of employment 16.15 9.84 28 214630 2216 63272148
Hypoxia 16.13 9.84 127 214531 59665 63214699
B-lymphocyte count increased 16.13 9.84 8 214650 114 63274250
Hyperkalaemia 16.12 9.84 112 214546 54091 63220273
Anal abscess 16.09 9.84 43 214615 4589 63269775
Ulcer 15.83 9.84 41 214617 26066 63248298
Macular degeneration 15.79 9.84 37 214621 24339 63250025
Metastases to lung 15.77 9.84 12 214646 12738 63261626
Full blood count decreased 15.68 9.84 41 214617 25983 63248381
Taste disorder 15.57 9.84 89 214569 13573 63260791
Bone marrow failure 15.56 9.84 49 214609 29241 63245123
Haematoma 15.34 9.84 63 214595 34757 63239607
Muscle rigidity 15.30 9.84 10 214648 11490 63262874
Red blood cell count decreased 15.26 9.84 78 214580 40567 63233797
Hyperemesis gravidarum 15.23 9.84 14 214644 578 63273786
Tendonitis 15.18 9.84 116 214542 19499 63254865
Blood potassium increased 15.17 9.84 24 214634 18285 63256079
Akathisia 15.09 9.84 6 214652 9140 63265224
Pituitary tumour recurrent 15.04 9.84 7 214651 86 63274278
Mitral valve incompetence 15.02 9.84 27 214631 19567 63254797
Tardive dyskinesia 15.00 9.84 5 214653 8497 63265867
Rectal haemorrhage 14.96 9.84 241 214417 48789 63225575
Cerebral microangiopathy 14.95 9.84 10 214648 257 63274107
Ventricular tachycardia 14.90 9.84 28 214630 19951 63254413
Depression 14.88 9.84 529 214129 195963 63078401
Catarrh 14.81 9.84 22 214636 1527 63272837
Myocardial ischaemia 14.78 9.84 13 214645 12846 63261518
Excessive skin 14.78 9.84 8 214650 138 63274226
Defaecation urgency 14.75 9.84 39 214619 4136 63270228
Sedation complication 14.69 9.84 15 214643 13807 63260557
Neoplasm malignant 14.47 9.84 52 214606 29809 63244555
Cough 14.43 9.84 826 213832 291917 62982447
Psychotic disorder 14.38 9.84 42 214616 25670 63248694
Sputum increased 14.31 9.84 28 214630 2431 63271933
Abnormal behaviour 14.30 9.84 32 214626 21394 63252970
Altered state of consciousness 14.27 9.84 41 214617 25189 63249175
Drug specific antibody present 14.26 9.84 39 214619 4220 63270144
Secondary hypogonadism 14.23 9.84 7 214651 98 63274266
Breast cancer stage I 14.14 9.84 3 214655 6886 63267478
Haematotoxicity 14.13 9.84 7 214651 9369 63264995
Proteinuria 14.13 9.84 27 214631 19118 63255246
Tuberculosis gastrointestinal 14.09 9.84 11 214647 362 63274002
CSF lymphocyte count abnormal 14.08 9.84 3 214655 0 63274364
Infection 13.92 9.84 926 213732 228247 63046117
Pain in jaw 13.88 9.84 88 214570 43408 63230956
C-reactive protein abnormal 13.85 9.84 226 214432 45870 63228494
Pulmonary embolism 13.79 9.84 295 214363 116389 63157975
Erythema nodosum 13.77 9.84 42 214616 4833 63269531
Labelled drug-drug interaction medication error 13.73 9.84 15 214643 13384 63260980
Pulmonary oedema 13.69 9.84 119 214539 54754 63219610
Extrapyramidal disorder 13.47 9.84 15 214643 13269 63261095
Mastocytosis 13.44 9.84 13 214645 573 63273791
Blood potassium decreased 13.42 9.84 85 214573 41941 63232423
Cerebral infarction 13.39 9.84 39 214619 23854 63250510
Enterococcal sepsis 13.36 9.84 20 214638 1398 63272966
Device malfunction 13.34 9.84 25 214633 17832 63256532
Cellulitis 13.25 9.84 196 214462 81762 63192602
Head injury 13.08 9.84 48 214610 27348 63247016
Tongue disorder 13.03 9.84 10 214648 10570 63263794
Oral candidiasis 13.01 9.84 126 214532 22672 63251692
Hypoaldosteronism 12.94 9.84 8 214650 179 63274185
Skin injury 12.83 9.84 22 214636 1726 63272638
Embolism venous 12.75 9.84 31 214627 3123 63271241
Abdominal pain 12.75 9.84 1155 213503 292301 62982063
Blood urea increased 12.74 9.84 46 214612 26333 63248031
Cerebral haemorrhage 12.68 9.84 57 214601 30672 63243692
Synovial cyst 12.67 9.84 10 214648 10423 63263941
Diabetic ketoacidosis 12.59 9.84 32 214626 20473 63253891
Hip fracture 12.57 9.84 54 214604 29420 63244944
Torsade de pointes 12.55 9.84 16 214642 13335 63261029
Gastrointestinal scarring 12.43 9.84 10 214648 344 63274020
Drug tolerance 12.41 9.84 4 214654 6945 63267419
Carpal tunnel syndrome 12.39 9.84 33 214625 20784 63253580
Atrial septal defect 12.38 9.84 4 214654 6934 63267430
Transplant rejection 12.27 9.84 11 214647 10769 63263595
Rash pruritic 12.27 9.84 136 214522 59663 63214701
Dysgeusia 12.24 9.84 100 214558 46610 63227754
Jaundice 12.23 9.84 54 214604 29197 63245167
Aspergillus infection 12.20 9.84 57 214601 8036 63266328
Insomnia 12.17 9.84 599 214059 214653 63059711
Aborted pregnancy 12.10 9.84 5 214653 45 63274319
Seronegative arthritis 12.03 9.84 35 214623 3924 63270440
Pus in stool 12.01 9.84 5 214653 46 63274318
Aggression 12.00 9.84 40 214618 23458 63250906
Disorientation 11.99 9.84 81 214577 39371 63234993
Vaginal haemorrhage 11.95 9.84 50 214608 27437 63246927
Restlessness 11.94 9.84 55 214603 29398 63244966
Acute generalised exanthematous pustulosis 11.85 9.84 12 214646 11087 63263277
Brachycephaly 11.84 9.84 4 214654 19 63274345
Ischaemic stroke 11.84 9.84 27 214631 17930 63256434
Faecal calprotectin abnormal 11.83 9.84 6 214652 90 63274274
White blood cell count increased 11.81 9.84 106 214552 48455 63225909
Diffuse large B-cell lymphoma 11.75 9.84 4 214654 6708 63267656
Breast cancer metastatic 11.72 9.84 14 214644 12004 63262360
Delusion 11.72 9.84 14 214644 12003 63262361
Tessellated fundus 11.64 9.84 5 214653 50 63274314
Blood pressure systolic abnormal 11.61 9.84 17 214641 13369 63260995
Mydriasis 11.58 9.84 14 214644 11942 63262422
Pulmonary toxicity 11.56 9.84 9 214649 9446 63264918
Neutrophilic panniculitis 11.56 9.84 5 214653 51 63274313
Osteomyelitis 11.51 9.84 47 214611 25973 63248391
Shared psychotic disorder 11.51 9.84 4 214654 21 63274343
Hypoperfusion 11.48 9.84 19 214639 1448 63272916
Increased bronchial secretion 11.38 9.84 21 214637 1745 63272619
Duodenal ulcer 11.38 9.84 6 214652 7750 63266614
Electrocardiogram QRS complex prolonged 11.37 9.84 3 214655 5935 63268429
Anorectal ulcer 11.31 9.84 5 214653 54 63274310
Norovirus test positive 11.30 9.84 8 214650 226 63274138
Mental status changes 11.21 9.84 83 214575 39516 63234848
Arteriosclerosis coronary artery 11.20 9.84 57 214601 8316 63266048
Blood pressure diastolic abnormal 11.18 9.84 20 214638 14522 63259842
Pneumatosis intestinalis 11.16 9.84 25 214633 2388 63271976
Chromaturia 11.13 9.84 25 214633 16692 63257672
PO2 decreased 11.11 9.84 19 214639 1487 63272877
Neutropenic infection 11.10 9.84 18 214640 1349 63273015
Non-consummation 11.07 9.84 5 214653 57 63274307
Pancreatic carcinoma 11.04 9.84 6 214652 7622 63266742
Pyoderma gangrenosum 10.97 9.84 32 214626 3593 63270771
Hypervolaemia 10.96 9.84 54 214604 28359 63246005
Tendon rupture 10.96 9.84 56 214602 8183 63266181
Adrenocorticotropic hormone deficiency 10.96 9.84 10 214648 409 63273955
Eye injury 10.94 9.84 28 214630 2911 63271453
Electrocardiogram abnormal 10.90 9.84 9 214649 9170 63265194
Skin necrosis 10.89 9.84 19 214639 13931 63260433
Burns second degree 10.89 9.84 22 214636 1956 63272408
Ankle fracture 10.86 9.84 28 214630 17827 63256537
Confusional state 10.82 9.84 934 213724 235446 63038918
Febrile neutropenia 10.82 9.84 497 214161 117952 63156412
Enthesopathy 10.79 9.84 8 214650 8606 63265758
Injection site mass 10.78 9.84 30 214628 18626 63255738
Invasive ductal breast carcinoma 10.78 9.84 5 214653 6953 63267411
Gamma-glutamyltransferase increased 10.78 9.84 69 214589 33962 63240402
Glomerular filtration rate decreased 10.78 9.84 18 214640 13423 63260941
Subdural haematoma 10.75 9.84 20 214638 14308 63260056
Skin weeping 10.74 9.84 13 214645 740 63273624
Blood pressure abnormal 10.72 9.84 22 214636 15176 63259188
Mood altered 10.70 9.84 21 214637 14722 63259642
Immunodeficiency 10.68 9.84 34 214624 20220 63254144
Pneumatosis 10.64 9.84 10 214648 425 63273939
Pain 10.64 9.84 2737 211921 737891 62536473
Leukoencephalopathy 10.63 9.84 36 214622 4377 63269987
Hepatic rupture 10.63 9.84 5 214653 63 63274301
Platelet count increased 10.60 9.84 28 214630 17683 63256681
Enterovirus infection 10.57 9.84 15 214643 999 63273365
Blood corticotrophin decreased 10.56 9.84 9 214649 336 63274028
Foetal death 10.48 9.84 13 214645 10967 63263397
Laboratory test abnormal 10.47 9.84 51 214607 26861 63247503
White blood cell count abnormal 10.45 9.84 4 214654 6238 63268126
Bone density decreased 10.44 9.84 21 214637 14591 63259773
Intermenstrual bleeding 10.40 9.84 7 214651 7919 63266445
Therapy non-responder 10.39 9.84 333 214325 75568 63198796
Accidental overdose 10.38 9.84 42 214616 23267 63251097
Status asthmaticus 10.36 9.84 14 214644 890 63273474
Retinitis 10.36 9.84 45 214613 6151 63268213
Therapeutic reaction time decreased 10.34 9.84 24 214634 2346 63272018
Respiratory tract infection 10.33 9.84 90 214568 41393 63232971
Miosis 10.33 9.84 6 214652 7347 63267017
Injection site rash 10.32 9.84 31 214627 18778 63255586
Surgery 10.29 9.84 75 214583 35837 63238527
Lymphocyte count decreased 10.29 9.84 60 214598 30197 63244167
Jaundice cholestatic 10.26 9.84 6 214652 7318 63267046
Vaginal abscess 10.26 9.84 10 214648 445 63273919
Optic glioma 10.21 9.84 3 214655 8 63274356
Product administration error 10.20 9.84 40 214618 22357 63252007
Dyspnoea exertional 10.17 9.84 143 214515 60159 63214205
Glucocorticoid deficiency 10.12 9.84 8 214650 268 63274096
Heart rate decreased 10.08 9.84 213 214445 45347 63229017
Aplastic anaemia 10.04 9.84 61 214597 9508 63264856
Astrocytoma 10.04 9.84 5 214653 72 63274292
Spondylitis 10.04 9.84 35 214623 4319 63270045
Blood growth hormone increased 9.98 9.84 10 214648 460 63273904
Eating disorder 9.97 9.84 32 214626 18984 63255380
Cerebral vasoconstriction 9.93 9.84 16 214642 1192 63273172
Nodule 9.93 9.84 37 214621 20989 63253375
Geotrichum infection 9.91 9.84 10 214648 464 63273900
Abortion induced 9.91 9.84 12 214646 10230 63264134
Visual pathway disorder 9.88 9.84 4 214654 34 63274330
Pituitary infarction 9.88 9.84 4 214654 34 63274330
Muscle spasticity 9.88 9.84 39 214619 21755 63252609

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 276.87 10.17 537 92258 59279 34804857
Blood pressure fluctuation 247.61 10.17 320 92475 24929 34839207
Adrenal insufficiency 233.27 10.17 234 92561 13813 34850323
Drug abuse 224.03 10.17 9 92786 99087 34765049
Completed suicide 203.09 10.17 15 92780 98153 34765983
Toxicity to various agents 196.64 10.17 147 92648 200215 34663921
Off label use 191.35 10.17 1822 90973 417702 34446434
Death 187.24 10.17 496 92299 397553 34466583
Inappropriate schedule of product administration 177.47 10.17 461 92334 61835 34802301
Craniopharyngioma 166.29 10.17 52 92743 247 34863889
Adrenocortical insufficiency acute 153.29 10.17 78 92717 1522 34862614
Infusion related reaction 152.50 10.17 394 92401 52663 34811473
Graft loss 133.68 10.17 59 92736 824 34863312
Condition aggravated 131.15 10.17 916 91879 191280 34672856
Frequent bowel movements 126.79 10.17 163 92632 12624 34851512
Colitis ulcerative 126.71 10.17 186 92609 16334 34847802
Febrile bone marrow aplasia 115.20 10.17 125 92670 8084 34856052
Serum sickness 108.19 10.17 67 92728 1933 34862203
Adrenal suppression 106.97 10.17 46 92749 601 34863535
Heart rate decreased 99.82 10.17 244 92551 31501 34832635
Hypofibrinogenaemia 89.99 10.17 56 92739 1630 34862506
Febrile neutropenia 83.86 10.17 636 92159 136213 34727923
Bronchiectasis 83.46 10.17 116 92679 9685 34854451
Aplastic anaemia 82.75 10.17 115 92680 9601 34854535
Heart rate irregular 81.84 10.17 149 92646 15658 34848478
Faecal calprotectin increased 80.02 10.17 61 92734 2483 34861653
Hypopituitarism 79.10 10.17 58 92737 2224 34861912
Impaired quality of life 77.14 10.17 86 92709 5732 34858404
Intentional overdose 74.55 10.17 13 92782 43661 34820475
Drug level below therapeutic 74.45 10.17 83 92712 5532 34858604
Diabetes insipidus 66.36 10.17 58 92737 2870 34861266
Drug interaction 66.02 10.17 342 92453 225604 34638532
Leukoencephalopathy 65.92 10.17 68 92727 4147 34859989
Interstitial lung disease 65.05 10.17 47 92748 65235 34798901
Product use issue 64.55 10.17 335 92460 62881 34801255
Drug specific antibody present 64.46 10.17 60 92735 3225 34860911
Overdose 60.97 10.17 92 92703 90967 34773169
Body temperature fluctuation 59.21 10.17 43 92752 1624 34862512
Steroid withdrawal syndrome 56.03 10.17 22 92773 224 34863912
Steroid dependence 55.87 10.17 40 92755 1477 34862659
Cortisol decreased 54.08 10.17 35 92760 1092 34863044
Mucosal inflammation 52.89 10.17 223 92572 38399 34825737
Arthralgia 51.56 10.17 683 92112 169358 34694778
Pituitary tumour benign 48.89 10.17 30 92765 851 34863285
Fall 48.65 10.17 327 92468 202558 34661578
Tendon pain 48.07 10.17 49 92746 2946 34861190
Myocardial infarction 47.20 10.17 164 92631 120921 34743215
Blood pressure increased 47.09 10.17 397 92398 87705 34776431
Insulin-like growth factor decreased 47.08 10.17 20 92775 253 34863883
Anal inflammation 44.97 10.17 33 92762 1267 34862869
Soft tissue mass 44.89 10.17 30 92765 989 34863147
Tendon disorder 44.27 10.17 46 92749 2829 34861307
Eczema 44.04 10.17 128 92667 18308 34845828
Acute kidney injury 43.90 10.17 559 92236 304429 34559707
Gingival disorder 43.17 10.17 34 92761 1453 34862683
Septic shock 42.89 10.17 332 92463 71502 34792634
Pseudostroke 42.67 10.17 12 92783 36 34864100
Fistula 42.63 10.17 70 92725 6770 34857366
Multimorbidity 42.14 10.17 28 92767 914 34863222
Cardiac failure 40.90 10.17 116 92679 91132 34773004
Suicide attempt 40.50 10.17 27 92768 39089 34825047
Oesophageal perforation 40.49 10.17 30 92765 1169 34862967
Therapeutic response shortened 39.86 10.17 71 92724 7333 34856803
Sedation 38.72 10.17 5 92790 21001 34843135
Anaemia 38.03 10.17 416 92379 232919 34631217
Atrial fibrillation 37.54 10.17 182 92613 122211 34741925
Insulin-like growth factor increased 37.33 10.17 29 92766 1214 34862922
Anal fissure 36.86 10.17 51 92744 4239 34859897
Weight increased 36.19 10.17 392 92403 92641 34771495
Tendon rupture 36.17 10.17 66 92729 6946 34857190
Hypophysitis 35.96 10.17 37 92758 2249 34861887
Poor venous access 34.98 10.17 55 92740 5128 34859008
Drug level decreased 34.49 10.17 69 92726 7777 34856359
Hypertriglyceridaemia 34.42 10.17 72 92723 8376 34855760
Flushing 33.90 10.17 173 92622 32247 34831889
Colitis 33.10 10.17 192 92603 37558 34826578
Superinfection 32.99 10.17 37 92758 2482 34861654
Neoplasm recurrence 32.88 10.17 35 92760 2214 34861922
Hypogonadism 32.80 10.17 35 92760 2220 34861916
Anal fistula 31.97 10.17 54 92741 5345 34858791
Erythema 31.32 10.17 367 92428 88413 34775723
Growth retardation 31.06 10.17 31 92764 1817 34862319
Pelvic abscess 30.61 10.17 23 92772 916 34863220
Cardio-respiratory arrest 30.50 10.17 63 92732 55210 34808926
Gastrointestinal haemorrhage 30.47 10.17 126 92669 88351 34775785
Renal impairment 29.87 10.17 139 92656 94374 34769762
Blood pressure diastolic decreased 29.75 10.17 71 92724 9023 34855113
Epiphysiolysis 29.51 10.17 11 92784 96 34864040
Secondary adrenocortical insufficiency 29.13 10.17 27 92768 1443 34862693
Meningitis candida 28.61 10.17 10 92785 71 34864065
Crohn's disease 28.21 10.17 38 92757 3079 34861057
Hallucination 27.33 10.17 60 92735 51438 34812698
Subdural haematoma 27.32 10.17 10 92785 20411 34843725
Lichen planus 27.20 10.17 22 92773 977 34863159
Oral disorder 27.18 10.17 44 92751 4205 34859931
Dermatitis atopic 27.16 10.17 50 92745 5297 34858839
Idiopathic intracranial hypertension 27.01 10.17 19 92776 682 34863454
Chorioretinopathy 26.87 10.17 26 92769 1467 34862669
Myelopathy 26.60 10.17 33 92762 2464 34861672
Thyroxine free decreased 26.54 10.17 14 92781 295 34863841
Hypertrophic cardiomyopathy 26.38 10.17 23 92772 1134 34863002
Thermophobia 26.36 10.17 9 92786 59 34864077
Thyrotoxic periodic paralysis 25.98 10.17 11 92784 138 34863998
Pituitary haemorrhage 25.95 10.17 12 92783 188 34863948
Angina pectoris 25.87 10.17 27 92768 31336 34832800
Drug hypersensitivity 25.84 10.17 327 92468 80202 34783934
Feeling cold 25.54 10.17 74 92721 10565 34853571
Respiratory disorder 25.41 10.17 110 92685 19154 34844982
Neuroleptic malignant syndrome 25.35 10.17 8 92787 17926 34846210
Renal failure 24.89 10.17 224 92571 130333 34733803
Rash erythematous 24.53 10.17 131 92664 24846 34839290
Abdominal pain 24.27 10.17 587 92208 163031 34701105
Electrocardiogram QT prolonged 24.04 10.17 45 92750 40907 34823229
Platelet count decreased 23.88 10.17 203 92592 119514 34744622
Posterior reversible encephalopathy syndrome 23.66 10.17 69 92726 9885 34854251
Meningitis tuberculous 22.82 10.17 17 92778 668 34863468
Perioral dermatitis 22.76 10.17 10 92785 138 34863998
Drug ineffective 22.74 10.17 1453 91342 455298 34408838
SARS-CoV-2 test negative 22.70 10.17 20 92775 1000 34863136
Chills 22.65 10.17 321 92474 80722 34783414
Blood growth hormone decreased 22.43 10.17 7 92788 33 34864103
Disease progression 22.13 10.17 182 92613 107895 34756241
Adrenocorticotropic hormone deficiency 21.95 10.17 19 92776 928 34863208
Shared psychotic disorder 21.85 10.17 6 92789 16 34864120
Anal abscess 21.67 10.17 51 92744 6422 34857714
Transplant failure 21.66 10.17 36 92759 3517 34860619
Extrapyramidal disorder 21.61 10.17 4 92791 12876 34851260
Hyperkalaemia 21.36 10.17 103 92692 69286 34794850
Weight fluctuation 20.90 10.17 44 92751 5141 34858995
Blood creatine phosphokinase increased 20.85 10.17 56 92739 44801 34819335
Device dislocation 20.67 10.17 49 92746 6200 34857936
Lactic acidosis 20.60 10.17 38 92757 34734 34829402
Aggression 20.18 10.17 46 92749 38918 34825218
Respiratory depression 20.03 10.17 9 92786 16236 34847900
Strongyloidiasis 20.03 10.17 30 92765 2681 34861455
Weight decreased 20.02 10.17 611 92184 175690 34688446
Musculoskeletal injury 19.99 10.17 9 92786 132 34864004
Coronary artery disease 19.78 10.17 64 92731 48241 34815895
Intentional self-injury 19.72 10.17 6 92789 13765 34850371
Pneumoretroperitoneum 19.64 10.17 9 92786 138 34863998
Symptom masked 19.43 10.17 15 92780 622 34863514
Transient ischaemic attack 19.35 10.17 27 92768 27586 34836550
Gastrointestinal inflammation 19.33 10.17 34 92761 3477 34860659
Cholangitis infective 19.31 10.17 11 92784 271 34863865
Body temperature decreased 19.21 10.17 77 92718 12957 34851179
Stevens-Johnson syndrome 19.16 10.17 99 92696 18540 34845596
Periorbital infection 19.07 10.17 9 92786 148 34863988
Coma 19.06 10.17 60 92735 45618 34818518
Haematochezia 18.98 10.17 198 92597 46336 34817800
Intentional product misuse 18.97 10.17 60 92735 45551 34818585
Skin irritation 18.74 10.17 44 92751 5533 34858603
Optic nerve disorder 18.72 10.17 15 92780 657 34863479
Strabismus 18.64 10.17 23 92772 1708 34862428
Cushingoid 18.59 10.17 29 92766 2685 34861451
Blood growth hormone increased 18.50 10.17 12 92783 376 34863760
Immunosuppressant drug level increased 18.45 10.17 46 92749 6009 34858127
Intestinal intraepithelial lymphocytes increased 18.39 10.17 9 92786 161 34863975
Hospitalisation 18.38 10.17 83 92712 56819 34807317
Pyrexia 18.32 10.17 1069 91726 331944 34532192
Haemorrhoids 18.29 10.17 82 92713 14493 34849643
Depressed level of consciousness 18.07 10.17 56 92739 42785 34821351
Tooth injury 18.05 10.17 19 92776 1186 34862950
Bronchial haemorrhage 18.02 10.17 15 92780 694 34863442
Pruritus 18.01 10.17 499 92296 141482 34722654
Chronic kidney disease 18.00 10.17 53 92742 41157 34822979
Syncope 17.82 10.17 156 92639 91295 34772841
Rhabdomyolysis 17.76 10.17 107 92688 68056 34796080
Candida infection 17.46 10.17 93 92702 17622 34846514
Astrocytoma 17.40 10.17 9 92786 182 34863954
Bradycardia 17.32 10.17 123 92672 75295 34788841
Inflammatory marker increased 17.25 10.17 40 92755 4988 34859148
White blood cell count decreased 17.21 10.17 166 92629 95279 34768857
Body temperature increased 16.99 10.17 91 92704 17277 34846859
Splenic peliosis 16.88 10.17 5 92790 19 34864117
Stress 16.86 10.17 138 92657 30209 34833927
Glioma 16.58 10.17 11 92784 358 34863778
Klebsiella infection 16.46 10.17 55 92740 8476 34855660
Pituitary tumour 16.45 10.17 13 92782 558 34863578
Pouchitis 16.29 10.17 14 92781 677 34863459
Vestibular neuronitis 16.28 10.17 9 92786 209 34863927
Cardiac failure congestive 16.24 10.17 142 92653 83128 34781008
Blood pressure diastolic increased 16.18 10.17 39 92756 4986 34859150
Pharyngitis streptococcal 16.10 10.17 27 92768 2657 34861479
Neuralgia 16.04 10.17 81 92714 15032 34849104
Product quality issue 16.02 10.17 13 92782 17022 34847114
Kounis syndrome 16.00 10.17 26 92769 2492 34861644
Lung consolidation 15.93 10.17 43 92752 5893 34858243
Accidental exposure to product 15.93 10.17 7 92788 12795 34851341
Cryptococcal fungaemia 15.84 10.17 7 92788 98 34864038
Pituitary tumour recurrent 15.84 10.17 7 92788 98 34864038
Clostridium difficile infection 15.84 10.17 95 92700 18803 34845333
Mantle cell lymphoma stage III 15.78 10.17 5 92790 25 34864111
Lacrimal duct neoplasm 15.78 10.17 5 92790 25 34864111
Hyperbilirubinaemia 15.64 10.17 87 92708 16756 34847380
Cryptitis 15.61 10.17 9 92786 227 34863909
Otitis media acute 15.61 10.17 13 92782 602 34863534
Delirium 15.54 10.17 62 92733 43929 34820207
Malignant neoplasm progression 15.51 10.17 154 92641 87892 34776244
Body height below normal 15.40 10.17 9 92786 233 34863903
Aphthous ulcer 15.27 10.17 38 92757 4957 34859179
Diarrhoea haemorrhagic 15.23 10.17 46 92749 6718 34857418
Perineal infection 15.17 10.17 13 92782 626 34863510
Hydrocephalus 15.16 10.17 39 92756 5193 34858943
Melaena 15.10 10.17 46 92749 35334 34828802
Blood thyroid stimulating hormone decreased 15.09 10.17 22 92773 1919 34862217
Posturing 15.05 10.17 12 92783 522 34863614
Eczema herpeticum 14.98 10.17 8 92787 173 34863963
Anaplastic astrocytoma 14.95 10.17 7 92788 113 34864023
Scrotal infection 14.93 10.17 13 92782 640 34863496
Proctalgia 14.90 10.17 41 92754 5682 34858454
Blood pressure systolic increased 14.76 10.17 108 92687 22844 34841292
Gastrointestinal anastomotic leak 14.75 10.17 11 92784 433 34863703
Bladder cancer 14.60 10.17 13 92782 16265 34847871
Back pain 14.60 10.17 425 92370 121364 34742772
Impaired work ability 14.56 10.17 46 92749 6884 34857252
Cerebral infarction 14.55 10.17 32 92763 27423 34836713
Sepsis 14.55 10.17 560 92235 166001 34698135
Wrong technique in product usage process 14.51 10.17 48 92747 35938 34828198
Shunt malfunction 14.46 10.17 8 92787 186 34863950
Rectal haemorrhage 14.45 10.17 167 92628 40082 34824054
Skin exfoliation 14.31 10.17 123 92672 27309 34836827
Disseminated cryptococcosis 14.26 10.17 18 92777 1368 34862768
Microvillous inclusion disease 14.23 10.17 8 92787 192 34863944
Congenital cardiovascular anomaly 14.23 10.17 8 92787 192 34863944
Addison's disease 14.22 10.17 4 92791 12 34864124
Pneumonia 14.17 10.17 803 91992 361824 34502312
Renal disorder 14.09 10.17 29 92766 25451 34838685
Pulmonary arterial hypertension 14.06 10.17 3 92792 8736 34855400
Dyspnoea exertional 14.05 10.17 63 92732 43216 34820920
Perineal pain 14.05 10.17 14 92781 819 34863317
Cryptococcal meningoencephalitis 13.97 10.17 7 92788 132 34864004
Probiotic therapy 13.92 10.17 7 92788 133 34864003
Anaphylactic reaction 13.91 10.17 139 92656 32162 34831974
Dermatitis diaper 13.79 10.17 9 92786 285 34863851
Optic nerve operation 13.79 10.17 11 92784 479 34863657
Abscess 13.73 10.17 65 92730 11752 34852384
Suicidal ideation 13.59 10.17 58 92737 40330 34823806
Lip swelling 13.58 10.17 81 92714 15999 34848137
Glioblastoma multiforme 13.56 10.17 13 92782 725 34863411
Prothrombin level abnormal 13.45 10.17 6 92789 86 34864050
Cardiac disorder 13.28 10.17 64 92731 43062 34821074
Blood creatinine increased 13.26 10.17 175 92620 94801 34769335
Leukopenia 13.24 10.17 105 92690 62751 34801385
Short stature 13.03 10.17 6 92789 93 34864043
Hepatic function abnormal 12.99 10.17 67 92728 44296 34819840
Apnoeic attack 12.93 10.17 10 92785 416 34863720
Cerebrospinal fluid leakage 12.92 10.17 11 92784 525 34863611
Perirectal abscess 12.84 10.17 19 92776 1679 34862457
Product dose omission issue 12.83 10.17 232 92563 119479 34744657
Functional gastrointestinal disorder 12.80 10.17 22 92773 2209 34861927
Adrenal insufficiency neonatal 12.73 10.17 3 92792 3 34864133
Administration site bruise 12.73 10.17 3 92792 3 34864133
Stress at work 12.73 10.17 8 92787 237 34863899
Blood corticotrophin increased 12.70 10.17 6 92789 99 34864037
Rectal abscess 12.68 10.17 17 92778 1371 34862765
Rash 12.59 10.17 717 92078 222035 34642101
Urticaria 12.54 10.17 234 92561 62143 34801993
Serotonin syndrome 12.51 10.17 21 92774 19912 34844224
Cerebral haemorrhage 12.49 10.17 49 92746 34888 34829248
Pharyngeal paraesthesia 12.46 10.17 12 92783 673 34863463
General physical health deterioration 12.39 10.17 253 92542 128016 34736120
Feeling hot 12.37 10.17 91 92704 19281 34844855
Multiple organ dysfunction syndrome 12.35 10.17 278 92517 76288 34787848
Gram stain positive 12.33 10.17 6 92789 106 34864030
Heart rate increased 12.32 10.17 182 92613 46161 34817975
Neurotoxicity 12.31 10.17 86 92709 17924 34846212
Lung neoplasm malignant 12.19 10.17 17 92778 17378 34846758
Phaeochromocytoma crisis 12.16 10.17 5 92790 58 34864078
Anorectal disorder 12.12 10.17 15 92780 1117 34863019
Prostate cancer 12.11 10.17 59 92736 39590 34824546
Cardiac failure chronic 12.09 10.17 3 92792 7876 34856260
Foetal exposure during pregnancy 12.05 10.17 56 92739 38045 34826091
Blood glucose increased 12.04 10.17 116 92679 66602 34797534
Myelitis transverse 12.04 10.17 15 92780 1125 34863011
Liver disorder 11.98 10.17 46 92749 32951 34831185
Short-bowel syndrome 11.94 10.17 8 92787 265 34863871
Blood luteinising hormone decreased 11.93 10.17 6 92789 114 34864022
Incorrect dose administered 11.93 10.17 162 92633 40353 34823783
Neutrophil count decreased 11.90 10.17 83 92712 51021 34813115
Pharyngitis bacterial 11.86 10.17 5 92790 62 34864074
Trichosporon infection 11.76 10.17 12 92783 722 34863414
Agranulocytosis 11.63 10.17 29 92766 23792 34840344
Pallor 11.63 10.17 111 92684 25369 34838767
Hypernatraemia 11.60 10.17 49 92746 8441 34855695
Drug level above therapeutic 11.57 10.17 31 92764 4230 34859906
Coordination abnormal 11.56 10.17 3 92792 7641 34856495
Skin warm 11.53 10.17 21 92774 2206 34861930
Congenital adrenal gland hypoplasia 11.52 10.17 3 92792 6 34864130
Dermal cyst 11.49 10.17 19 92776 1848 34862288
Infected dermal cyst 11.48 10.17 13 92782 881 34863255
Tracheobronchitis 11.48 10.17 14 92781 1027 34863109
Full blood count abnormal 11.41 10.17 20 92775 18648 34845488
Potentiating drug interaction 11.35 10.17 34 92761 4943 34859193
Dry skin 11.31 10.17 130 92665 31157 34832979
Toxic epidermal necrolysis 11.26 10.17 97 92698 21549 34842587
Unmasking of previously unidentified disease 11.25 10.17 13 92782 901 34863235
Rales 11.22 10.17 54 92741 9829 34854307
Chronic sinusitis 11.19 10.17 21 92774 2258 34861878
Mean cell volume decreased 11.18 10.17 16 92779 1372 34862764
Lichenification 11.18 10.17 9 92786 397 34863739
Morganella infection 11.15 10.17 10 92785 512 34863624
Blood corticotrophin decreased 11.15 10.17 7 92788 207 34863929
Arm amputation 11.14 10.17 6 92789 132 34864004
Haemoglobin decreased 11.14 10.17 240 92555 120532 34743604
Skin papilloma 11.11 10.17 20 92775 2083 34862053
Apoptosis 11.08 10.17 9 92786 402 34863734
Antibody test abnormal 11.03 10.17 7 92788 211 34863925
Psychotic disorder 11.01 10.17 31 92764 24421 34839715
Thyroxine decreased 11 10.17 7 92788 212 34863924
Contraindicated product prescribed 10.97 10.17 9 92786 408 34863728
Biopsy 10.95 10.17 8 92787 305 34863831
Gonadotrophin deficiency 10.93 10.17 4 92791 33 34864103
Leptotrichia infection 10.83 10.17 5 92790 78 34864058
Cortisol abnormal 10.82 10.17 4 92791 34 34864102
Mental fatigue 10.71 10.17 6 92789 143 34863993
Metabolic acidosis 10.64 10.17 70 92725 43610 34820526
Type 1 diabetes mellitus 10.59 10.17 30 92765 4228 34859908
Loss of consciousness 10.58 10.17 155 92640 82512 34781624
Pulmonary artery dilatation 10.55 10.17 7 92788 228 34863908
Hypothalamo-pituitary disorder 10.54 10.17 12 92783 818 34863318
Anal haemorrhage 10.54 10.17 22 92773 2556 34861580
Hypothyroidism 10.53 10.17 93 92702 20809 34843327
Defaecation urgency 10.47 10.17 22 92773 2567 34861569
Haematemesis 10.47 10.17 38 92757 27673 34836463
Diplegia 10.30 10.17 13 92782 988 34863148
Delusion 10.28 10.17 11 92784 12624 34851512
Blood culture positive 10.28 10.17 32 92763 4751 34859385
Hypersensitivity 10.28 10.17 223 92572 60812 34803324
Unevaluable event 10.24 10.17 48 92747 32542 34831594
Liver function test abnormal 10.23 10.17 45 92750 31029 34833107
Dizziness 10.21 10.17 475 92320 218046 34646090
Necrotising bronchiolitis 10.21 10.17 3 92792 11 34864125
Job dissatisfaction 10.21 10.17 6 92789 157 34863979
Skin lesion 10.19 10.17 96 92699 21865 34842271

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 683.46 9.47 21 252810 245746 79245811
Intentional product use issue 648.06 9.47 1466 251365 150646 79340911
Toxicity to various agents 558.25 9.47 322 252509 421218 79070339
Infusion related reaction 541.48 9.47 1783 251048 228454 79263103
Pericarditis 449.72 9.47 1010 251821 103226 79388331
Drug abuse 448.25 9.47 15 252816 162676 79328881
Wound 446.79 9.47 1076 251755 115103 79376454
Anti-cyclic citrullinated peptide antibody positive 441.55 9.47 877 251954 82266 79409291
Glossodynia 433.26 9.47 990 251841 102347 79389210
Duodenal ulcer perforation 428.32 9.47 760 252071 65451 79426106
Systemic lupus erythematosus 412.28 9.47 1071 251760 120078 79371479
Pemphigus 411.93 9.47 949 251882 98633 79392924
Helicobacter infection 404.02 9.47 763 252068 68941 79422616
Hand deformity 386.25 9.47 950 251881 102969 79388588
Discomfort 365.05 9.47 1048 251783 124569 79366988
Adrenocortical insufficiency acute 353.50 9.47 179 252652 2864 79488693
Rheumatoid factor positive 346.75 9.47 655 252176 59184 79432373
Death 335.87 9.47 819 252012 565695 78925862
Inappropriate schedule of product administration 314.77 9.47 1036 251795 132592 79358965
Blood pressure fluctuation 297.80 9.47 658 252173 66487 79425070
Adrenal insufficiency 282.78 9.47 398 252433 28089 79463468
Blister 270.44 9.47 914 251917 118562 79372995
Synovitis 267.80 9.47 1066 251765 149668 79341889
Rheumatic fever 258.97 9.47 382 252449 28143 79463414
Drug interaction 247.53 9.47 598 252233 414585 79076972
Off label use 245.39 9.47 4135 248696 903080 78588477
Arthropathy 237.31 9.47 1151 251680 175960 79315597
Condition aggravated 234.34 9.47 2523 250308 498601 78992956
Product use issue 230.31 9.47 1290 251541 208532 79283025
Alopecia 222.07 9.47 1373 251458 229982 79261575
Swelling 220 9.47 1305 251526 215406 79276151
Irritable bowel syndrome 213.39 9.47 552 252279 61689 79429868
Folliculitis 209.62 9.47 510 252321 54870 79436687
Intentional overdose 208.88 9.47 41 252790 105919 79385638
Fall 203.92 9.47 825 252006 486804 79004753
Overdose 200.88 9.47 173 252658 184033 79307524
Colitis ulcerative 200.86 9.47 380 252451 34362 79457195
Abdominal discomfort 200.69 9.47 1422 251409 249305 79242252
Hepatic enzyme increased 200.56 9.47 1123 251708 181487 79310070
Hypersensitivity 200.52 9.47 1471 251360 260768 79230789
Craniopharyngioma 192.17 9.47 65 252766 335 79491222
Maternal exposure during pregnancy 189.84 9.47 897 251934 135641 79355916
Swollen joint count increased 189.61 9.47 294 252537 22633 79468924
Acute kidney injury 181.85 9.47 938 251893 518466 78973091
Muscle injury 177.20 9.47 441 252390 48120 79443437
Steroid withdrawal syndrome 154.89 9.47 65 252766 656 79490901
Blood cholesterol increased 153.36 9.47 598 252233 83122 79408435
Frequent bowel movements 150.04 9.47 306 252525 29233 79462324
Sleep disorder due to general medical condition, insomnia type 147.96 9.47 385 252446 43171 79448386
Type 2 diabetes mellitus 144.49 9.47 454 252377 56668 79434889
Drug level below therapeutic 142.01 9.47 165 252666 9605 79481952
Hip arthroplasty 139.28 9.47 333 252498 35423 79456134
Fibromyalgia 133.17 9.47 478 252353 63862 79427695
Interstitial lung disease 132.44 9.47 98 252733 112502 79379055
Drug intolerance 130.72 9.47 1346 251485 262773 79228784
Secondary immunodeficiency 128.99 9.47 96 252735 3138 79488419
Injury 127.96 9.47 536 252295 76960 79414597
Anaemia 126.27 9.47 859 251972 444156 79047401
Weight increased 126.25 9.47 1390 251441 275996 79215561
Drug hypersensitivity 114.85 9.47 1450 251381 297466 79194091
Suicide attempt 112.90 9.47 61 252770 82871 79408686
Faecal calprotectin increased 111.21 9.47 111 252720 5430 79486127
Impaired healing 109.72 9.47 559 252272 87096 79404461
Rash 109.16 9.47 2499 250332 575859 78915698
Myocardial infarction 108.11 9.47 267 252564 183862 79307695
Deep vein thrombosis postoperative 107.85 9.47 151 252680 10601 79480956
Sedation 104.56 9.47 19 252812 51876 79439681
Atrial fibrillation 99.75 9.47 309 252522 197577 79293980
Lip dry 98.38 9.47 176 252655 15242 79476315
Heart rate irregular 98.09 9.47 276 252555 32403 79459154
Facet joint syndrome 97.77 9.47 148 252683 11154 79480403
Liver injury 97.72 9.47 397 252434 56217 79435340
Psoriatic arthropathy 96.63 9.47 496 252335 77503 79414054
Contraindicated product administered 95.33 9.47 838 251993 156700 79334857
Lower respiratory tract infection 94.72 9.47 718 252113 128502 79363055
Cardio-respiratory arrest 91.57 9.47 126 252705 108384 79383173
Coma 90.98 9.47 111 252720 100538 79391019
Pituitary tumour benign 90.72 9.47 71 252760 2505 79489052
Cardiac failure 90.52 9.47 225 252606 154617 79336940
Gastrointestinal haemorrhage 89.24 9.47 211 252620 147508 79344049
Knee arthroplasty 88.38 9.47 320 252511 42928 79448629
Renal impairment 86.34 9.47 237 252594 157546 79334011
Autoimmune disorder 85.44 9.47 173 252658 16439 79475118
Febrile bone marrow aplasia 84.84 9.47 150 252681 12870 79478687
Body temperature fluctuation 83.38 9.47 80 252751 3727 79487830
Hypopituitarism 83.24 9.47 76 252755 3323 79488234
Syncope 83.00 9.47 291 252540 179158 79312399
Heart rate decreased 82.86 9.47 441 252390 69875 79421682
Therapeutic response shortened 80.17 9.47 164 252667 15699 79475858
Anal fissure 78.48 9.47 109 252722 7594 79483963
Aplastic anaemia 77.69 9.47 174 252657 17731 79473826
Platelet count decreased 77.65 9.47 335 252496 194329 79297228
Product dose omission issue 77.16 9.47 464 252367 247073 79244484
Secondary adrenocortical insufficiency 76.97 9.47 69 252762 2945 79488612
Live birth 76.73 9.47 178 252653 18566 79472991
Peripheral venous disease 76.32 9.47 161 252670 15748 79475809
Diabetes insipidus 75.37 9.47 88 252743 5149 79486408
Cortisol decreased 74.62 9.47 59 252772 2113 79489444
Therapeutic product effect decreased 74.40 9.47 821 252010 163042 79328515
Poor venous access 73.91 9.47 172 252659 17977 79473580
Depressed level of consciousness 73.07 9.47 121 252710 96531 79395026
Stomatitis 73.03 9.47 749 252082 146008 79345549
Intentional product misuse 73.01 9.47 118 252713 95047 79396510
Arthralgia 71.97 9.47 2345 250486 569458 78922099
Adjustment disorder with depressed mood 71.64 9.47 114 252717 8972 79482585
Cardiac failure congestive 70.59 9.47 224 252607 142178 79349379
Electrocardiogram QT prolonged 70.35 9.47 111 252720 90275 79401282
Joint swelling 70.03 9.47 1295 251536 287351 79204206
Bradycardia 69.48 9.47 210 252621 135347 79356210
Fistula 69.23 9.47 137 252694 12803 79478754
Steroid dependence 68.73 9.47 61 252770 2569 79488988
Disease progression 68.30 9.47 326 252505 184036 79307521
Respiratory arrest 67.77 9.47 50 252781 57500 79434057
Leukoencephalopathy 67.41 9.47 103 252728 7826 79483731
Human bocavirus infection 67.17 9.47 37 252794 708 79490849
Pneumonia 66.55 9.47 1590 251241 658656 78832901
Haemoglobin decreased 66.28 9.47 422 252409 221697 79269860
Drug specific antibody present 66.09 9.47 93 252738 6559 79484998
Mycobacterium chelonae infection 64.26 9.47 57 252774 2399 79489158
Lactic acidosis 64.21 9.47 77 252754 70282 79421275
Cognitive disorder 63.31 9.47 77 252754 69849 79421708
Serotonin syndrome 62.93 9.47 32 252799 44995 79446562
Full blood count abnormal 62.45 9.47 25 252806 40449 79451108
Treatment failure 62.42 9.47 820 252011 169666 79321891
Ill-defined disorder 61.85 9.47 389 252442 65486 79426071
Hypofibrinogenaemia 61.62 9.47 51 252780 1951 79489606
Bacterial infection 61.01 9.47 228 252603 31052 79460505
Intentional self-injury 60.89 9.47 14 252817 32405 79459152
Febrile neutropenia 60.48 9.47 1049 251782 229950 79261607
White blood cell count decreased 59.68 9.47 351 252480 187937 79303620
Blood creatine phosphokinase increased 58.55 9.47 74 252757 66016 79425541
Blood creatinine increased 58.12 9.47 273 252558 154784 79336773
Device expulsion 57.78 9.47 7 252824 25854 79465703
Drug level decreased 57.02 9.47 135 252696 14267 79477290
Anti-cyclic citrullinated peptide antibody 56.94 9.47 81 252750 5771 79485786
Malignant neoplasm progression 56.71 9.47 230 252601 135760 79355797
Neutropenia 56.11 9.47 612 252219 287098 79204459
Neoplasm recurrence 56.02 9.47 68 252763 4146 79487411
Prescribed overdose 55.63 9.47 253 252578 37630 79453927
Leukopenia 55.17 9.47 187 252644 116326 79375231
Pruritus 53.64 9.47 1634 251197 393014 79098543
Neuroleptic malignant syndrome 53.59 9.47 11 252820 27548 79464009
Melaena 53.09 9.47 69 252762 60821 79430736
Exposure during pregnancy 51.66 9.47 519 252312 100613 79390944
Renal failure 51.52 9.47 399 252432 200569 79290988
Nasopharyngitis 51.50 9.47 1109 251722 252772 79238785
Hepatic function abnormal 50.33 9.47 97 252734 73010 79418547
Adrenal suppression 50.22 9.47 39 252792 1360 79490197
Cerebrovascular accident 50.00 9.47 288 252543 155004 79336553
Urticaria 49.90 9.47 845 251986 184356 79307201
Adverse event 49.52 9.47 344 252487 59870 79431687
Pseudostroke 49.43 9.47 16 252815 70 79491487
Hyperkalaemia 48.00 9.47 193 252638 114205 79377352
Dislocation of vertebra 47.79 9.47 88 252743 7792 79483765
Eczema 47.40 9.47 255 252576 40563 79450994
Norovirus test positive 46.64 9.47 28 252803 634 79490923
Wrong technique in product usage process 46.64 9.47 103 252728 73772 79417785
Breast cancer stage III 46.63 9.47 99 252732 9727 79481830
Anal fistula 46.54 9.47 81 252750 6863 79484694
Cardiac arrest 46.33 9.47 337 252494 171759 79319798
Lower limb fracture 45.93 9.47 170 252661 23045 79468512
Perioral dermatitis 45.92 9.47 23 252808 359 79491198
Hypophysitis 45.54 9.47 61 252770 4105 79487452
Gastrointestinal disorder 45.23 9.47 589 252242 121616 79369941
Meningitis candida 44.95 9.47 17 252814 127 79491430
Maternal exposure timing unspecified 44.74 9.47 72 252759 5720 79485837
Wheezing 44.74 9.47 566 252265 116098 79375459
Suicidal ideation 44.54 9.47 111 252720 76229 79415328
Rhabdomyolysis 44.53 9.47 172 252659 102959 79388598
Hepatotoxicity 43.95 9.47 59 252772 51293 79440264
Hallucination 43.81 9.47 133 252698 85612 79405945
Thrombocytopenia 42.71 9.47 588 252243 264671 79226886
Nausea 42.15 9.47 2546 250285 954650 78536907
Insulin-like growth factor decreased 41.88 9.47 25 252806 560 79490997
Transient ischaemic attack 41.68 9.47 64 252767 52631 79438926
Metabolic acidosis 41.46 9.47 129 252702 82400 79409157
Thymus hypoplasia 41.33 9.47 30 252801 943 79490614
Accidental exposure to product 41.23 9.47 24 252807 31298 79460259
Insulin-like growth factor increased 40.12 9.47 39 252792 1847 79489710
Joint range of motion decreased 40.06 9.47 210 252621 33072 79458485
Adverse drug reaction 40.04 9.47 353 252478 66039 79425518
Loss of consciousness 40.03 9.47 340 252491 167603 79323954
Cystitis bacterial 39.87 9.47 26 252805 684 79490873
Respiratory depression 39.57 9.47 19 252812 27611 79463946
Female genital tract fistula 39.14 9.47 69 252762 5906 79485651
Human herpesvirus 6 infection 39.11 9.47 65 252766 5305 79486252
Balance disorder 38.86 9.47 171 252660 98686 79392871
Contusion 38.68 9.47 675 252156 148101 79343456
Somnolence 38.37 9.47 530 252301 238451 79253106
Lymphoid tissue hypoplasia 37.97 9.47 28 252803 902 79490655
Tendon pain 37.92 9.47 66 252765 5592 79485965
Night sweats 37.88 9.47 289 252542 51806 79439751
Poisoning deliberate 37.70 9.47 7 252824 18821 79472736
Pseudomonal sepsis 37.51 9.47 69 252762 6105 79485452
Orthostatic hypotension 37.38 9.47 76 252755 56088 79435469
Anal inflammation 37.04 9.47 33 252798 1397 79490160
Clostridium difficile colitis 37.02 9.47 201 252630 32082 79459475
Hypotension 36.99 9.47 1088 251743 439229 79052328
Extrapyramidal disorder 36.68 9.47 13 252818 22666 79468891
Cardiac disorder 36.53 9.47 98 252733 65659 79425898
Rhinovirus infection 36.44 9.47 79 252752 7874 79483683
C-reactive protein 35.90 9.47 60 252771 4919 79486638
Hypothalamo-pituitary disorder 35.89 9.47 30 252801 1164 79490393
Haematuria 35.72 9.47 106 252725 68730 79422827
Chronic kidney disease 35.70 9.47 100 252731 66054 79425503
Musculoskeletal stiffness 35.63 9.47 765 252066 174243 79317314
Pulmonary arterial hypertension 35.58 9.47 23 252808 28343 79463214
Injection site erythema 35.33 9.47 128 252703 78069 79413488
Parainfluenzae virus infection 35.15 9.47 64 252767 5618 79485939
Strongyloidiasis 35.08 9.47 52 252779 3846 79487711
Schizophrenia 34.94 9.47 4 252827 15436 79476121
Subdural haematoma 34.87 9.47 29 252802 31405 79460152
Drug level above therapeutic 34.79 9.47 82 252749 8641 79482916
Myelosuppression 34.78 9.47 46 252785 40250 79451307
Grip strength decreased 34.33 9.47 149 252682 21720 79469837
Acute myocardial infarction 34.22 9.47 127 252704 76909 79414648
Blood pressure increased 33.63 9.47 893 251938 210467 79281090
Parkinsonism 33.56 9.47 6 252825 16578 79474979
Coronary artery disease 33.13 9.47 102 252729 65372 79426185
Anal abscess 33.11 9.47 84 252747 9271 79482286
Hypogonadism 33.03 9.47 34 252797 1726 79489831
X-ray abnormal 32.87 9.47 63 252768 5750 79485807
Eczema herpeticum 32.55 9.47 17 252814 291 79491266
Pituitary haemorrhage 32.39 9.47 17 252814 294 79491263
Sciatica 32.32 9.47 198 252633 33024 79458533
Septic shock 32.22 9.47 558 252273 122243 79369314
Shared psychotic disorder 32.21 9.47 10 252821 37 79491520
Agitation 32.05 9.47 185 252646 99530 79392027
Soft tissue mass 31.93 9.47 29 252802 1259 79490298
Bladder cancer 31.91 9.47 11 252820 19515 79472042
Wound infection 31.41 9.47 155 252676 23836 79467721
Bursitis 31.39 9.47 208 252623 35636 79455921
Hospitalisation 31.28 9.47 173 252658 94063 79397494
International normalised ratio increased 31.24 9.47 150 252681 84571 79406986
Aspartate aminotransferase increased 31.12 9.47 285 252546 138356 79353201
Chronic obstructive pulmonary disease 31.06 9.47 152 252679 85267 79406290
Osteonecrosis of jaw 30.94 9.47 56 252775 43170 79448387
Liver function test abnormal 30.84 9.47 103 252728 64372 79427185
Unevaluable event 30.75 9.47 83 252748 55502 79436055
Arrhythmia 30.62 9.47 96 252735 61176 79430381
Perfume sensitivity 30.46 9.47 24 252807 855 79490702
Pituitary tumour recurrent 30.44 9.47 14 252817 179 79491378
Alanine aminotransferase increased 30.40 9.47 349 252482 162221 79329336
Hyperadrenocorticism 30.19 9.47 17 252814 340 79491217
Hypercalcaemia 30.08 9.47 47 252784 38383 79453174
Aggression 29.80 9.47 74 252757 50884 79440673
Proctalgia 29.55 9.47 84 252747 9917 79481640
Injection site swelling 29.51 9.47 66 252765 47066 79444491
Lupus vulgaris 29.20 9.47 44 252787 3302 79488255
Cerebral haemorrhage 29.07 9.47 90 252741 57583 79433974
Incorrect dose administered 29.04 9.47 371 252460 76259 79415298
Impaired quality of life 29.01 9.47 106 252725 14280 79477277
Road traffic accident 28.88 9.47 237 252594 43427 79448130
Breast cancer 28.71 9.47 39 252792 33742 79457815
Fluid retention 28.51 9.47 119 252712 69690 79421867
Neutrophil count decreased 28.26 9.47 178 252653 93781 79397776
Mucosal inflammation 28.26 9.47 365 252466 75215 79416342
Colitis 28.24 9.47 356 252475 72951 79418606
Angina pectoris 28.06 9.47 78 252753 51654 79439903
Product prescribing error 27.86 9.47 63 252768 44750 79446807
Injection site pain 27.82 9.47 270 252561 129568 79361989
Infection 27.44 9.47 980 251851 240732 79250825
Multimorbidity 27.37 9.47 28 252803 1411 79490146
Drug resistance 27.35 9.47 58 252773 42155 79449402
Blood glucose increased 27.28 9.47 233 252598 114742 79376815
Salpingo-oophorectomy unilateral 27.26 9.47 22 252809 812 79490745
Hypoaesthesia 27.16 9.47 753 252078 178599 79312958
Oesophageal perforation 27.07 9.47 29 252802 1542 79490015
Jaundice 27.07 9.47 83 252748 53266 79438291
Cerebral infarction 26.97 9.47 66 252765 45610 79445947
Growth retardation 26.89 9.47 32 252799 1911 79489646
Urticaria thermal 26.72 9.47 17 252814 428 79491129
Upper gastrointestinal haemorrhage 26.69 9.47 57 252774 41323 79450234
Sleep disorder 26.47 9.47 400 252431 85277 79406280
Pneumatosis intestinalis 26.46 9.47 61 252770 6336 79485221
Chronic sinusitis 26.28 9.47 96 252735 12930 79478627
Haematochezia 25.85 9.47 406 252425 87239 79404318
Creatinine renal clearance decreased 25.82 9.47 14 252817 18988 79472569
Lung neoplasm malignant 25.80 9.47 30 252801 27762 79463795
Dermatitis atopic 25.48 9.47 80 252751 9976 79481581
Toxic skin eruption 25.44 9.47 20 252811 22273 79469284
Dyskinesia 25.42 9.47 66 252765 44707 79446850
Enterobacter infection 25.25 9.47 49 252782 4513 79487044
Pneumoretroperitoneum 25.12 9.47 12 252819 168 79491389
Agranulocytosis 25.09 9.47 67 252764 44963 79446594
Delusion 25.02 9.47 17 252814 20406 79471151
Red blood cell sedimentation rate abnormal 24.96 9.47 18 252813 20945 79470612
Body temperature decreased 24.89 9.47 181 252650 31964 79459593
Therapy cessation 24.85 9.47 51 252780 37511 79454046
Therapy interrupted 24.85 9.47 38 252793 31303 79460254
Mobility decreased 24.84 9.47 534 252297 121641 79369916
Thermophobia 24.80 9.47 9 252822 59 79491498
Erythema nodosum 24.57 9.47 53 252778 5264 79486293
Injection site reaction 24.54 9.47 90 252741 54695 79436862
Natural killer-cell leukaemia 24.36 9.47 10 252821 95 79491462
Pulmonary hypertension 24.26 9.47 75 252756 48005 79443552
Metastases to bone 24.18 9.47 25 252806 24402 79467155
Walking aid user 24.14 9.47 79 252752 10069 79481488
Drug withdrawal syndrome 23.95 9.47 46 252785 34672 79456885
Tremor 23.91 9.47 387 252444 169696 79321861
Hypomagnesaemia 23.79 9.47 73 252758 46838 79444719
Hyperhidrosis 23.58 9.47 338 252493 151154 79340403
Epidural lipomatosis 23.55 9.47 24 252807 1204 79490353
Asthenia 23.49 9.47 1355 251476 510334 78981223
Candida infection 23.46 9.47 204 252627 38010 79453547
Obesity 23.42 9.47 191 252640 34934 79456623
Renal disorder 23.20 9.47 63 252768 42042 79449515
Multiple sclerosis relapse 23.18 9.47 73 252758 46460 79445097
Hypothalamic pituitary adrenal axis suppression 23.17 9.47 14 252817 321 79491236
Skin ulcer 22.93 9.47 91 252740 54059 79437498
Epiphysiolysis 22.91 9.47 10 252821 112 79491445
Myelodysplastic syndrome 22.83 9.47 38 252793 30263 79461294
Dysarthria 22.52 9.47 124 252707 67498 79424059
Sinusitis 22.51 9.47 794 252037 194707 79296850
Vaginal discharge 22.36 9.47 63 252768 7400 79484157
Astrocytoma 22.29 9.47 12 252819 219 79491338
Pneumonia aspiration 22.19 9.47 123 252708 66844 79424713
Rheumatoid nodule 22.06 9.47 14 252817 17424 79474133
Abdominal pain 22.03 9.47 1475 251356 388094 79103463
Psychotic disorder 22.03 9.47 63 252768 41339 79450218
Blood potassium increased 21.79 9.47 37 252794 29238 79462319
Pulmonary oedema 21.77 9.47 177 252654 88077 79403480
Proteinuria 21.61 9.47 44 252787 32458 79459099
Normal tension glaucoma 21.36 9.47 8 252823 58 79491499
Defaecation urgency 21.35 9.47 53 252778 5771 79485786
Viraemia 21.26 9.47 35 252796 2834 79488723
Oedema peripheral 21.25 9.47 623 252208 251665 79239892
Femur fracture 21.17 9.47 58 252773 38594 79452963
Adrenocorticotropic hormone deficiency 21.16 9.47 24 252807 1361 79490196
Abscess bacterial 21.11 9.47 19 252812 815 79490742
Mucous stools 21.10 9.47 49 252782 5113 79486444
Musculoskeletal injury 21.07 9.47 11 252820 188 79491369
Epistaxis 21.00 9.47 239 252592 111276 79380281
Tendon disorder 20.89 9.47 60 252771 7126 79484431
Blood corticotrophin decreased 20.85 9.47 16 252815 548 79491009
Ventricular tachycardia 20.74 9.47 66 252765 41869 79449688
Atrial flutter 20.45 9.47 23 252808 21602 79469955
Thyrotoxic periodic paralysis 20.26 9.47 10 252821 151 79491406
Herpes zoster 20.18 9.47 193 252638 92890 79398667
Muscle rigidity 20.08 9.47 20 252811 19862 79471695
Blood alkaline phosphatase increased 19.98 9.47 119 252712 63545 79428012
Flushing 19.98 9.47 392 252439 87876 79403681
Blood pressure diastolic decreased 19.98 9.47 164 252667 30052 79461505
Dyspnoea exertional 19.97 9.47 178 252653 86895 79404662
Enthesopathy 19.92 9.47 6 252825 11602 79479955
Diarrhoea haemorrhagic 19.89 9.47 89 252742 13145 79478412
Accidental overdose 19.78 9.47 62 252769 39519 79452038
Gait inability 19.75 9.47 279 252552 58638 79432919
Drug reaction with eosinophilia and systemic symptoms 19.68 9.47 121 252710 64123 79427434
Enteritis 19.65 9.47 95 252736 14488 79477069
Dizziness 19.55 9.47 1421 251410 525020 78966537
Device difficult to use 19.48 9.47 9 252822 13376 79478181
Blood urea increased 19.41 9.47 84 252747 48706 79442851
Dyspnoea 19.36 9.47 2401 250430 854624 78636933
Eosinophilia 19.33 9.47 76 252755 45269 79446288
Pain 19.32 9.47 2530 250301 701272 78790285
Allergy test positive 19.25 9.47 17 252814 711 79490846
Herpes simplex oesophagitis 19.22 9.47 13 252818 364 79491193
Myelopathy 18.96 9.47 44 252787 4589 79486968
Feeling abnormal 18.96 9.47 373 252458 158826 79332731
Bronchitis 18.78 9.47 296 252535 130348 79361209
Ischaemic stroke 18.68 9.47 49 252782 33082 79458475
Panniculitis 18.51 9.47 8 252823 12363 79479194
Hallucination, auditory 18.50 9.47 23 252808 20670 79470887
Drug eruption 18.50 9.47 74 252757 43861 79447696
Haematoma 18.33 9.47 94 252737 52101 79439456
Blood corticotrophin increased 18.31 9.47 10 252821 188 79491369
White blood cell count increased 18.26 9.47 150 252681 74483 79417074
Urinary retention 18.23 9.47 105 252726 56525 79435032
Dry skin 18.20 9.47 310 252521 67685 79423872
Atrioventricular block 18.14 9.47 11 252820 14030 79477527
Bone marrow failure 17.97 9.47 92 252739 51015 79440542
Sedation complication 17.95 9.47 14 252817 15655 79475902
Diffuse large B-cell lymphoma 17.95 9.47 8 252823 12141 79479416
Palmar-plantar erythrodysaesthesia syndrome 17.94 9.47 50 252781 33084 79458473
Airway peak pressure increased 17.81 9.47 12 252819 334 79491223
Symptom masked 17.78 9.47 22 252809 1368 79490189
Colorectal cancer 17.78 9.47 3 252828 8644 79482913
Dehydration 17.75 9.47 626 252205 247561 79243996
Haematotoxicity 17.61 9.47 14 252817 15505 79476052
Hyperemesis gravidarum 17.47 9.47 13 252818 425 79491132
Angina unstable 17.42 9.47 16 252815 16511 79475046
Gastrointestinal inflammation 17.30 9.47 58 252773 7486 79484071
Pituitary infarction 17.29 9.47 7 252824 64 79491493
Pharyngeal paraesthesia 17.28 9.47 31 252800 2690 79488867
Cerebrospinal fluid leakage 17.25 9.47 24 252807 1675 79489882
Right ventricular failure 17.21 9.47 30 252801 23467 79468090
Granuloma skin 17.15 9.47 4 252827 9170 79482387
Loss of employment 17.11 9.47 30 252801 2557 79489000
Mitral valve incompetence 17.08 9.47 41 252790 28524 79463033
Musculoskeletal disorder 17.01 9.47 26 252805 21422 79470135
Cardiac failure chronic 16.98 9.47 7 252824 11128 79480429
Adrenal disorder 16.97 9.47 27 252804 2124 79489433
Cardiac failure acute 16.97 9.47 21 252810 18908 79472649
Anticipatory anxiety 16.94 9.47 20 252811 1184 79490373
Systemic infection 16.81 9.47 5 252826 9747 79481810
Osteomyelitis 16.77 9.47 51 252780 32814 79458743
Gastroenteritis norovirus 16.76 9.47 33 252798 3073 79488484
Myalgia 16.75 9.47 454 252377 185187 79306370
Catarrh 16.72 9.47 27 252804 2151 79489406
Prostate cancer 16.71 9.47 52 252779 33216 79458341
Acute generalised exanthematous pustulosis 16.70 9.47 18 252813 17236 79474321
Pancytopenia 16.65 9.47 399 252432 165346 79326211
Glioblastoma multiforme 16.62 9.47 20 252811 1208 79490349
Osteoarthritis 16.60 9.47 378 252453 86931 79404626
Hypernatraemia 16.59 9.47 90 252741 14361 79477196
Underdose 16.52 9.47 52 252779 33099 79458458
Pyoderma gangrenosum 16.49 9.47 39 252792 4119 79487438
Intestinal intraepithelial lymphocytes increased 16.39 9.47 9 252822 171 79491386
Thrombosis 16.32 9.47 179 252652 83921 79407636
Sinusitis fungal 16.31 9.47 28 252803 2346 79489211
Breast cancer female 16.23 9.47 8 252823 11453 79480104
Blepharospasm 16.19 9.47 48 252783 5803 79485754
Oedema 16.16 9.47 495 252336 119085 79372472
Splenic peliosis 16.00 9.47 5 252826 19 79491538
Altered state of consciousness 15.92 9.47 78 252753 43744 79447813
Atrioventricular block first degree 15.84 9.47 10 252821 12481 79479076
Miosis 15.81 9.47 16 252815 15773 79475784
Rheumatoid arthritis 15.79 9.47 522 252309 207948 79283609
Viral infection 15.76 9.47 207 252624 42809 79448748
Kounis syndrome 15.73 9.47 39 252792 4243 79487314
Weight decreased 15.72 9.47 1319 251512 353879 79137678
Product quality issue 15.70 9.47 55 252776 33885 79457672
Apathy 15.64 9.47 11 252820 12966 79478591
Product use in unapproved indication 15.60 9.47 956 251875 249403 79242154
Skin fragility 15.57 9.47 17 252814 924 79490633
Glioma 15.41 9.47 14 252817 608 79490949
Tooth injury 15.38 9.47 25 252806 2003 79489554
Mydriasis 15.37 9.47 20 252811 17623 79473934
Blood bilirubin increased 15.36 9.47 135 252696 66097 79425460
Tenosynovitis 15.31 9.47 16 252815 15538 79476019
Pregnancy 15.28 9.47 141 252690 26710 79464847
Blood growth hormone increased 15.24 9.47 15 252816 721 79490836
Renal cancer 15.22 9.47 10 252821 12216 79479341
Therapeutic reaction time decreased 15.16 9.47 34 252797 3467 79488090
Metastases to liver 15.12 9.47 43 252788 28271 79463286
Unmasking of previously unidentified disease 15.12 9.47 25 252806 2032 79489525
Blood calcium decreased 15.10 9.47 51 252780 31768 79459789
Pleural effusion 15.06 9.47 348 252483 144914 79346643
Oxygen saturation abnormal 15.04 9.47 40 252791 4542 79487015
Mastocytosis 15.03 9.47 13 252818 529 79491028
Akathisia 15.00 9.47 12 252819 13247 79478310
Tendon rupture 14.93 9.47 77 252754 12049 79479508
Abnormal behaviour 14.92 9.47 62 252769 36359 79455198
Cerebral microangiopathy 14.88 9.47 10 252821 277 79491280
Pouchitis 14.87 9.47 17 252814 972 79490585
Granulocytopenia 14.71 9.47 9 252822 11422 79480135
Electrocardiogram QRS complex prolonged 14.69 9.47 8 252823 10825 79480732
Morganella infection 14.68 9.47 18 252813 1109 79490448
Pulmonary embolism 14.66 9.47 423 252408 171231 79320326
Migraine 14.58 9.47 372 252459 87121 79404436
Acute graft versus host disease 14.55 9.47 7 252824 10160 79481397
Natural killer cell count decreased 14.52 9.47 6 252825 58 79491499
Anorectal disorder 14.40 9.47 26 252805 2267 79489290
Aphasia 14.33 9.47 88 252743 46644 79444913
Excessive eye blinking 14.32 9.47 22 252809 1679 79489878
Lichen planus 14.27 9.47 29 252802 2762 79488795
Burns second degree 14.27 9.47 28 252803 2600 79488957
Gamma-glutamyltransferase increased 14.26 9.47 108 252723 54572 79436985
Vertigo 14.23 9.47 145 252686 68937 79422620
Dystonia 14.20 9.47 29 252802 21370 79470187
Tongue disorder 14.18 9.47 14 252817 13961 79477596
Oropharyngeal pain 14.07 9.47 450 252381 108903 79382654
Anaplastic astrocytoma 14.03 9.47 8 252823 164 79491393
Seizure 14.03 9.47 474 252357 188360 79303197
Hepatic cancer 13.96 9.47 8 252823 10521 79481036
Exposure to SARS-CoV-2 13.90 9.47 24 252807 2020 79489537
Dermatitis diaper 13.90 9.47 10 252821 310 79491247
Ventricular hypokinesia 13.88 9.47 6 252825 9273 79482284
C-reactive protein abnormal 13.86 9.47 223 252608 48144 79443413
Strabismus 13.86 9.47 27 252804 2494 79489063
Abdominal pain upper 13.82 9.47 854 251977 222965 79268592
Cerebral vasoconstriction 13.79 9.47 20 252811 1450 79490107
Faecaloma 13.67 9.47 10 252821 11554 79480003
Weight fluctuation 13.59 9.47 73 252758 11602 79479955
Hypercholesterolaemia 13.51 9.47 122 252709 22973 79468584
Proctitis 13.48 9.47 48 252783 6384 79485173
Red blood cell count decreased 13.44 9.47 117 252714 57396 79434161
SARS-CoV-2 test negative 13.37 9.47 19 252812 1352 79490205
Autoimmune nephritis 13.37 9.47 14 252817 725 79490832
Purpura 13.36 9.47 26 252805 19501 79472056
Myoclonus 13.35 9.47 44 252787 27616 79463941
Tubulointerstitial nephritis 13.35 9.47 69 252762 38166 79453391
Peptic ulcer haemorrhage 13.32 9.47 16 252815 965 79490592
Atrioventricular block complete 13.30 9.47 20 252811 16590 79474967
Germ cell cancer 13.29 9.47 8 252823 182 79491375
Coronavirus infection 13.27 9.47 53 252778 7444 79484113
Haematemesis 13.27 9.47 104 252727 52160 79439397
Hyperreflexia 13.23 9.47 5 252826 8380 79483177
Hypertension 13.23 9.47 1220 251611 329772 79161785
Transplant rejection 13.19 9.47 26 252805 19411 79472146
Cortisol abnormal 13.16 9.47 6 252825 75 79491482
Excessive skin 13.14 9.47 7 252824 125 79491432
Gingival pain 13.14 9.47 60 252771 8938 79482619
Nasal polyps 13.13 9.47 52 252779 7275 79484282
Cholestasis 13.08 9.47 104 252727 52005 79439552
Pseudohypoaldosteronism 13.04 9.47 5 252826 39 79491518
Blood potassium decreased 13.03 9.47 90 252741 46422 79445135
Shunt malfunction 13 9.47 9 252822 262 79491295
Therapy partial responder 12.94 9.47 22 252809 17375 79474182
Ulcer 12.92 9.47 50 252781 29922 79461635
Duodenal ulcer 12.83 9.47 20 252811 16349 79475208
Dysphagia 12.83 9.47 292 252539 121844 79369713
Ventricular arrhythmia 12.78 9.47 6 252825 8834 79482723
Haemorrhoids 12.77 9.47 145 252686 28983 79462574
Bone disorder 12.60 9.47 26 252805 19087 79472470
Product storage error 12.55 9.47 20 252811 16206 79475351
Restlessness 12.52 9.47 91 252740 46401 79445156
Drug ineffective 12.52 9.47 3722 249109 1077191 78414366
Haemorrhagic stroke 12.49 9.47 10 252821 11036 79480521
Glomerular filtration rate decreased 12.48 9.47 34 252797 22668 79468889
Tuberculosis gastrointestinal 12.45 9.47 12 252819 562 79490995
Vaginal infection 12.43 9.47 44 252787 5836 79485721
Superinfection 12.42 9.47 39 252792 4863 79486694
Aborted pregnancy 12.42 9.47 5 252826 45 79491512
Inflammation 12.38 9.47 387 252444 93366 79398191
Antithrombin III 12.37 9.47 6 252825 87 79491470
Breast cancer stage I 12.37 9.47 3 252828 6697 79484860
Product label confusion 12.27 9.47 20 252811 1606 79489951
Hypertensive crisis 12.27 9.47 30 252801 20740 79470817
B-lymphocyte count increased 12.26 9.47 7 252824 144 79491413
Thyroxine free decreased 12.25 9.47 16 252815 1051 79490506
Cryptitis 12.23 9.47 9 252822 289 79491268
Hypoaldosteronism 12.23 9.47 10 252821 376 79491181
Meningitis tuberculous 12.20 9.47 17 252814 1188 79490369
Plasma cell myeloma 12.16 9.47 109 252722 53150 79438407
Eye haemorrhage 12.12 9.47 8 252823 9749 79481808
Eosinophilic oesophagitis 12.11 9.47 12 252819 582 79490975
Optic nerve operation 12.09 9.47 11 252820 479 79491078
Angioedema 12.05 9.47 169 252662 75866 79415691
Renal injury 12.05 9.47 22 252809 16905 79474652
Microvillous inclusion disease 12.05 9.47 8 252823 217 79491340
Lymphocyte count decreased 12.05 9.47 94 252737 47195 79444362
Diplegia 12.04 9.47 21 252810 1782 79489775
Pituitary tumour 12.02 9.47 17 252814 1205 79490352
Tessellated fundus 11.95 9.47 5 252826 50 79491507
Hepatocellular injury 11.94 9.47 95 252736 47498 79444059
Embolism venous 11.94 9.47 35 252796 4204 79487353
Gastric ulcer 11.94 9.47 61 252770 33844 79457713
Probiotic therapy 11.88 9.47 7 252824 153 79491404
Abscess 11.82 9.47 118 252713 22833 79468724
Rib fracture 11.81 9.47 47 252784 27900 79463657
Jaundice cholestatic 11.80 9.47 11 252820 11273 79480284
Dry mouth 11.80 9.47 364 252467 87655 79403902
Scrotal infection 11.79 9.47 12 252819 601 79490956
Optic glioma 11.78 9.47 5 252826 52 79491505
Disseminated cryptococcosis 11.78 9.47 21 252810 1813 79489744
Gastric cancer 11.78 9.47 9 252822 10170 79481387
Metastases to lung 11.73 9.47 25 252806 18138 79473419
Enterocolonic fistula 11.72 9.47 7 252824 157 79491400
Nephropathy toxic 11.67 9.47 30 252801 20389 79471168
Vaginal abscess 11.66 9.47 10 252821 402 79491155
Uterine cyst 11.66 9.47 9 252822 311 79491246
Bronchopulmonary aspergillosis 11.66 9.47 115 252716 22179 79469378
Injection site bruising 11.66 9.47 79 252752 40923 79450634
Constipation 11.65 9.47 757 252074 282293 79209264
Anorectal ulcer 11.62 9.47 5 252826 54 79491503
Non-consummation 11.62 9.47 5 252826 54 79491503
Vulvovaginal candidiasis 11.55 9.47 25 252806 2489 79489068
Cushing's syndrome 11.54 9.47 15 252816 980 79490577
Intestinal resection 11.54 9.47 32 252799 3725 79487832
Synovial cyst 11.52 9.47 9 252822 10056 79481501
Sinus node dysfunction 11.49 9.47 5 252826 7696 79483861
Product monitoring error 11.48 9.47 7 252824 8899 79482658
Idiopathic intracranial hypertension 11.48 9.47 29 252802 3193 79488364
Dysgeusia 11.37 9.47 121 252710 57056 79434501
Viral parotitis 11.34 9.47 3 252828 5 79491552
Mental status changes 11.27 9.47 147 252684 66812 79424745
Growth hormone deficiency 11.27 9.47 10 252821 421 79491136
Disorientation 11.25 9.47 136 252695 62640 79428917
Hepatitis acute 11.24 9.47 20 252811 15522 79476035
Pancreatic carcinoma 11.21 9.47 16 252815 13561 79477996
Hypertriglyceridaemia 11.20 9.47 74 252757 12666 79478891
Chorioretinopathy 11.19 9.47 23 252808 2208 79489349
Cryptococcal fungaemia 11.15 9.47 7 252824 172 79491385
Basal cell carcinoma 11.14 9.47 71 252760 37304 79454253
Respiratory rate increased 11.09 9.47 111 252720 21489 79470068
Glucocorticoid deficiency 11.08 9.47 12 252819 646 79490911
Sputum increased 11.05 9.47 36 252795 4577 79486980
Coordination abnormal 11.04 9.47 24 252807 17288 79474269
Hypocalcaemia 11.04 9.47 103 252728 49821 79441736
Cryptococcal meningoencephalitis 11.01 9.47 8 252823 252 79491305
Psychomotor retardation 10.98 9.47 3 252828 6181 79485376
Drug tolerance 10.93 9.47 7 252824 8668 79482889
Posturing 10.88 9.47 15 252816 1038 79490519
Electrocardiogram abnormal 10.84 9.47 23 252808 16714 79474843
Death neonatal 10.83 9.47 12 252819 663 79490894
Full blood count decreased 10.77 9.47 46 252785 26773 79464784
Adenoidal hypertrophy 10.71 9.47 7 252824 185 79491372
Seronegative arthritis 10.69 9.47 36 252795 4656 79486901
Perineal infection 10.69 9.47 13 252818 794 79490763
COVID-19 pneumonia 10.68 9.47 51 252780 28798 79462759
Hyperuricaemia 10.67 9.47 13 252818 11786 79479771
Eosinophil count increased 10.67 9.47 24 252807 17081 79474476
Joint effusion 10.66 9.47 26 252805 17988 79473569
Therapeutic product effect incomplete 10.65 9.47 355 252476 141290 79350267
Lymphocytic hypophysitis 10.64 9.47 11 252820 561 79490996
Rectal abscess 10.63 9.47 22 252809 2123 79489434
Coronary arterial stent insertion 10.60 9.47 3 252828 6041 79485516
Mucosal hyperaemia 10.60 9.47 5 252826 68 79491489
Intestinal stenosis 10.58 9.47 31 252800 3723 79487834
Torsade de pointes 10.56 9.47 29 252802 19283 79472274
Hypoxia 10.51 9.47 248 252583 102995 79388562
Protein urine present 10.41 9.47 10 252821 10102 79481455
Hepatocellular carcinoma 10.41 9.47 8 252823 9013 79482544
Uveitis 10.41 9.47 90 252741 16740 79474817
Hallucination, visual 10.36 9.47 61 252770 32668 79458889
Anorectal discomfort 10.35 9.47 30 252801 3581 79487976
Faecal calprotectin abnormal 10.32 9.47 7 252824 197 79491360
Renal salt-wasting syndrome 10.25 9.47 12 252819 704 79490853
Paradoxical drug reaction 10.20 9.47 5 252826 7180 79484377
Nodule 10.15 9.47 38 252793 22956 79468601
Clostridium difficile infection 10.15 9.47 191 252640 42494 79449063
Sexual dysfunction 10.14 9.47 6 252825 7757 79483800
Infant irritability 10.14 9.47 3 252828 9 79491548
Basilar artery aneurysm 10.13 9.47 4 252827 34 79491523
Normochromic normocytic anaemia 10.06 9.47 6 252825 7721 79483836
Vaginal flatulence 10.04 9.47 24 252807 2551 79489006
Gonadotrophin deficiency 10.03 9.47 4 252827 35 79491522
Rash erythematous 10.03 9.47 247 252584 57522 79434035
Thyrotoxic crisis 9.97 9.47 16 252815 1268 79490289
Pulmonary alveolar haemorrhage 9.97 9.47 13 252818 11444 79480113
Sitting disability 9.96 9.47 9 252822 388 79491169
Oesophageal adenocarcinoma recurrent 9.93 9.47 4 252827 36 79491521
Manipulation 9.93 9.47 5 252826 79 79491478
Multiple-drug resistance 9.93 9.47 8 252823 8800 79482757
Nail disorder 9.91 9.47 68 252763 11784 79479773
Hepatitis C 9.90 9.47 14 252817 11911 79479646
Hyperamylasaemia 9.89 9.47 15 252816 1132 79490425
Cataract 9.87 9.47 138 252693 61982 79429575
Thyroglossal cyst infection 9.84 9.47 4 252827 37 79491520
Visual pathway disorder 9.82 9.47 5 252826 81 79491476
Gram stain positive 9.80 9.47 6 252825 141 79491416
Deafness 9.79 9.47 34 252797 21003 79470554
Aphthous ulcer 9.77 9.47 89 252742 16800 79474757
Catheterisation cardiac 9.76 9.47 3 252828 5725 79485832
Urosepsis 9.71 9.47 47 252784 26448 79465109
Myelitis transverse 9.68 9.47 20 252811 1927 79489630
Hypoperfusion 9.66 9.47 24 252807 2615 79488942
Herpes simplex 9.65 9.47 69 252762 12118 79479439
Shock haemorrhagic 9.62 9.47 32 252799 20028 79471529
Neutrophilic panniculitis 9.60 9.47 5 252826 85 79491472
Status asthmaticus 9.60 9.47 14 252817 1020 79490537
Acute hepatic failure 9.60 9.47 56 252775 30057 79461500
Infusion site streaking 9.55 9.47 10 252821 518 79491039
Ischaemia 9.53 9.47 7 252824 8068 79483489
Gestational diabetes 9.52 9.47 4 252827 6289 79485268
End stage renal disease 9.51 9.47 15 252816 12205 79479352
Arteriosclerosis 9.50 9.47 28 252803 18199 79473358
Pituitary-dependent Cushing's syndrome 9.48 9.47 3 252828 12 79491545
Skin injury 9.48 9.47 28 252803 3378 79488179

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 56.37 37.89 16 205 58 89513
Aspergillus infection 56.06 37.89 17 204 82 89489
Product use issue 41.47 37.89 16 205 175 89396
Hepatotoxicity 41.10 37.89 14 207 103 89468

Pharmacologic Action:

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

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Disorder of musculoskeletal system indication 928000 DOID:17
Cerebral edema indication 2032001
Otitis externa indication 3135009
Proctitis indication 3951002 DOID:3127
Keratitis indication 5888003 DOID:4677
Tinea pedis indication 6020002 DOID:12403
Berylliosis indication 8247009 DOID:10322
Psoriasis indication 9014002 DOID:8893
Ankylosing spondylitis indication 9631008 DOID:7147
Cyclitis indication 17657000
Rheumatic heart disease indication 23685000
Atopic dermatitis indication 24079001 DOID:3310
Inflammatory bowel disease indication 24526004 DOID:0050589
Multiple sclerosis indication 24700007 DOID:2377
Severe adrenal insufficiency indication 24867002
Sarcoidosis indication 31541009 DOID:11335
Idiopathic thrombocytopenic purpura indication 32273002 DOID:8924
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Tendinitis indication 34840004 DOID:971
Erythema multiforme indication 36715001
Contact dermatitis indication 40275004 DOID:2773
Angioedema indication 41291007 DOID:1558
Humoral hypercalcemia of malignancy indication 47709007
Articular gout indication 48440001 DOID:13189
Seborrheic dermatitis indication 50563003 DOID:8741
Edema of larynx indication 51599000
Chronic ulcerative proctitis indication 52231000
Nephrotic syndrome indication 52254009 DOID:1184
Lichen simplex chronicus indication 53891004
Systemic lupus erythematosus indication 55464009 DOID:9074
Allergic rhinitis indication 61582004
Ulcerative colitis indication 64766004 DOID:8577
Löffler's syndrome indication 64936001 DOID:9503
Iritis indication 65074000 DOID:1406
Pemphigus indication 65172003 DOID:9182
Granuloma annulare indication 65508009 DOID:3777
Tenosynovitis indication 67801009 DOID:970
Blepharoconjunctivitis indication 68659002 DOID:2456
Rheumatoid arthritis indication 69896004 DOID:7148
Hemorrhoids indication 70153002 DOID:9746
Transfusion reaction due to serum protein reaction indication 72284000
Acquired thrombocytopenia indication 74576004 DOID:11126
Iridocyclitis indication 77971008
Thyroiditis indication 82119001 DOID:7166
Bursitis indication 84017003 DOID:2965
Tinea corporis indication 84849002
Autoimmune disease indication 85828009
Corneal abrasion indication 85848002
Infective otitis externa indication 86981007 DOID:9463
Infection by larvae of Trichinella spiralis indication 88264003
Acne vulgaris indication 88616000
Congenital hypoplastic anemia indication 88854002 DOID:1339
Pruritus ani indication 90446007
Corneal ulcer indication 91514001 DOID:8463
Acute lymphoid leukemia indication 91857003 DOID:9952
Dermatitis herpetiformis indication 111196000 DOID:8505
Hodgkin's disease indication 118599009
Non-Hodgkin's lymphoma indication 118601006
Mycosis fungoides indication 118618005
Uveitis indication 128473001 DOID:13141
Aspiration pneumonitis indication 155597006
Asthma indication 195967001 DOID:2841
Discoid lupus erythematosus indication 200938002
Plaque psoriasis indication 200965009
Transplanted organ rejection indication 213148006
Malignant otitis externa due to Pseudomonas aeruginosa indication 232230009
Congenital adrenal hyperplasia indication 237751000
Scalp psoriasis indication 238608008
Punctate keratopathy indication 246936005
Adrenogenital disorder indication 267395000 DOID:0050811
Pruritus of genital organs indication 267802000
Eruption of skin indication 271807003 DOID:0050486
Infective blepharitis indication 312219000
Bacterial keratitis indication 314557000
Disorder of eye indication 371405004 DOID:5614
Primary adrenocortical insufficiency indication 373662000
Adrenal cortical hypofunction indication 386584007 DOID:10493
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Tinea cruris indication 399029005
Erythroderma indication 399992009
Primary cutaneous T-cell lymphoma indication 400122007
Recurrent herpes simplex labialis indication 402892009
Autoimmune hemolytic anemia indication 413603009 DOID:718
Synovitis indication 416209007 DOID:2703
Aphthous ulcer of mouth indication 426965005 DOID:9663
Allergic conjunctivitis indication 473460002 DOID:11204
Post traumatic osteoarthritis indication 699262001
Itching of ear indication 699392007
Inflammatory dermatosis indication 703938007
Post-Op Ocular Inflammation indication
Mastoidectomy Cavity Infections indication
Superficial Ocular Infection indication
Gingival Disorders indication
Minor Bacterial Skin Infections indication
Synovitis due to Osteoarthritis indication
Diagnostic Test for Cushing's Syndrome indication
Transfusion Reaction Urticaria indication
Staphylococcus Aureus Otitis Externa indication
Systemic Dermatomyositis indication
Erythroblastic Anemia indication
Chronic purulent otitis media off-label use 38394007 DOID:14247
Respiratory distress syndrome in the newborn off-label use 46775006
Adrenoleukodystrophy off-label use 65389002 DOID:10588
Pityriasis simplex off-label use 200767005
Allergic otitis externa off-label use 405821001
Itching of skin off-label use 418363000
Otitis Externa Seborrhea off-label use
Neonatal Bronchopulmonary Dysplasia off-label use
Congenital Pituitary Hypoplasia off-label use
Otitis Externa Eczema off-label use
Mycosis contraindication 3218000 DOID:1564
Ocular hypertension contraindication 4210003 DOID:9282
Herpes simplex keratitis contraindication 9389005
Bacterial septicemia contraindication 10001005 DOID:0040085
Inactive tuberculosis contraindication 11999007
Peptic ulcer contraindication 13200003 DOID:750
Measles contraindication 14189004 DOID:8622
Esophagitis contraindication 16761005 DOID:11963
Mood swings contraindication 18963009
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Cirrhosis of liver contraindication 19943007 DOID:5082
Herpes zoster auricularis contraindication 21954000 DOID:9210
Glaucoma contraindication 23986001 DOID:1686
Abscess of intestine contraindication 24557004
Acute tuberculosis contraindication 25629007
Shock contraindication 27942005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Bullous myringitis contraindication 33528003 DOID:13791
Severe myopia contraindication 34187009
Hyperthyroidism contraindication 34486009 DOID:7998
Gastrointestinal fistula contraindication 37831005
Hypertensive disorder contraindication 38341003 DOID:10763
Infectious disease contraindication 40733004
Hypothyroidism contraindication 40930008 DOID:1459
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Tuberculosis of eye contraindication 49107007
Duodenal ulcer disease contraindication 51868009 DOID:1724
Perforation of tympanic membrane contraindication 60442001
Osteoporosis contraindication 64859006 DOID:11476
Psychotic disorder contraindication 69322001
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Third degree burn injury contraindication 80247002
Hyperglycemia contraindication 80394007 DOID:4195
Decreased respiratory function contraindication 80954004
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes simplex contraindication 88594005 DOID:8566
Kidney disease contraindication 90708001 DOID:557
Disorder of mucous membrane contraindication 95351003
Bilateral cataracts contraindication 95722004
Open wound contraindication 125643001
Eye infection contraindication 128351009
Seizure disorder contraindication 128613002
Bacterial infection of eye contraindication 128984004
Disorder of muscle contraindication 129565002 DOID:423
Tuberculosis of ear contraindication 186269001
Ophthalmic herpes simplex contraindication 186542001
Heart block contraindication 233916004
Anastomosis of intestine contraindication 235407009
Disease of liver contraindication 235856003 DOID:409
Condyloma acuminatum contraindication 240542006 DOID:11168
Telangiectasia disorder contraindication 247479008
Diverticulitis of gastrointestinal tract contraindication 271366000
Injury of eye region contraindication 282752000
Varicella-zoster virus infection contraindication 309465005
Viral eye infection contraindication 312132001
Viral ear infection contraindication 312137007
Fungal ear infection contraindication 312148000
Infective otitis media contraindication 312218008
Skin irritation contraindication 367466007
Vaccinia keratitis contraindication 397552005
Gastric ulcer contraindication 397825006 DOID:10808
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Blister contraindication 417237009
Denuded skin contraindication 418242004
Exposure to varicella contraindication 444453009




🐶 Veterinary Drug Use

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

🐶 Veterinary products

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

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9717740 Nov. 19, 2032 TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9675559 Jan. 10, 2033 TREATMENT OF ADRENAL INSUFFICIENCY
0.5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
1MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
2MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY
5MG ALKINDI SPRINKLE ETON N213876 Sept. 29, 2020 RX GRANULE ORAL 9649280 May 12, 2034 TREATMENT OF ADRENAL INSUFFICIENCY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Glucocorticoid receptor Nuclear hormone receptor AGONIST EC50 8.50 WOMBAT-PK CHEMBL
Annexin A1 Cytosolic other WOMBAT-PK
Mineralocorticoid receptor Nuclear hormone receptor AGONIST IC50 9.95 IUPHAR
Nitric oxide synthase, inducible Enzyme IC50 8 WOMBAT-PK
Corticosteroid-binding globulin Secreted Ki 7.88 WOMBAT-PK
Sex hormone-binding globulin Secreted Kd 6.20 CHEMBL
Glucocorticoid receptor Transcription factor IC50 7.60 CHEMBL
Glucocorticoid receptor Transcription factor Kd 7.37 CHEMBL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0012 TABLET 5 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0012 TABLET 5 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0031 TABLET 10 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0031 TABLET 10 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0044 TABLET 20 mg ORAL NDA 15 sections
CORTEF HUMAN PRESCRIPTION DRUG LABEL 1 0009-0044 TABLET 20 mg ORAL NDA 15 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 10 mg AURICULAR (OTIC) NDA 16 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0065-8531 SUSPENSION 10 mg AURICULAR (OTIC) NDA 16 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0078-0855 SUSPENSION/ DROPS 10 mg AURICULAR (OTIC) NDA 16 sections
CIPROHC HUMAN PRESCRIPTION DRUG LABEL 2 0078-0855 SUSPENSION/ DROPS 10 mg AURICULAR (OTIC) NDA 16 sections
Aquanil HC HUMAN OTC DRUG LABEL 1 0096-0732 LOTION 0.01 g TOPICAL OTC monograph not final 10 sections
Aquanil HC HUMAN OTC DRUG LABEL 1 0096-0732 LOTION 0.01 g TOPICAL OTC monograph not final 10 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0471 OINTMENT 1 g TOPICAL OTC monograph not final 13 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-0541 CREAM 1 g TOPICAL OTC monograph not final 13 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-0793 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0973 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Good Sense Anti Itch HUMAN OTC DRUG LABEL 1 0113-0973 CREAM 1 g TOPICAL OTC monograph not final 13 sections
good sense anti itch HUMAN OTC DRUG LABEL 1 0113-1369 CREAM 1 g TOPICAL OTC monograph not final 13 sections
Basic Case Hydrocortisone Anti-Itch HUMAN OTC DRUG LABEL 1 0113-7006 CREAM 1 g TOPICAL OTC monograph not final 13 sections
basic care hydrocortisone HUMAN OTC DRUG LABEL 1 0113-7369 CREAM 1 g TOPICAL OTC monograph not final 13 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1696 TABLET 5 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1696 TABLET 5 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1697 TABLET 10 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1697 TABLET 10 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1700 TABLET 20 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN PRESCRIPTION DRUG LABEL 1 0115-1700 TABLET 20 mg ORAL ANDA 14 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0014 CREAM 5 mg TOPICAL OTC monograph final 9 sections
hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0015 CREAM 10 mg TOPICAL ANDA 19 sections
HYDROCORTISONE HUMAN OTC DRUG LABEL 1 0168-0016 OINTMENT 5 mg TOPICAL OTC monograph final 9 sections
Hydrocortisone HUMAN PRESCRIPTION DRUG LABEL 1 0168-0020 OINTMENT 10 mg TOPICAL ANDA 18 sections