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

Stem definitionDrug idCAS RN
916 58-73-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • benadryl
  • diphenhydramine salicylate
  • diphenhydramine laurylsulfate
  • diphenhydramine
  • benzhydramine
  • probedryl
  • diphenhydramine hydrochloride
  • diphenhydramine citrate
  • diphenhydramine HCl
A histamine H1 antagonist used as an antiemetic, antitussive, for dermatoses and pruritus, for hypersensitivity reactions, as a hypnotic, an antiparkinson, and as an ingredient in common cold preparations. It has some undesired antimuscarinic and sedative effects.
  • Molecular weight: 255.36
  • Formula: C17H21NO
  • CLOGP: 3.45
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 0
  • TPSA: 12.47
  • ALOGS: -3.53
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 3.26 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 72 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 6.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.19 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 4, 1946 FDA MCNEIL CONS

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
Completed suicide 2969.15 10.85 5504 680908 140169 62662441
Toxicity to various agents 2838.75 10.85 7414 678998 239836 62562774
Infusion related reaction 1175.99 10.85 5512 680900 240009 62562601
Exposure to toxic agent 749.87 10.85 561 685851 5026 62797584
Sinusitis 504.92 10.85 4180 682232 222473 62580137
Blood pressure fluctuation 491.13 10.85 1351 685061 44966 62757644
Overdose 473.20 10.85 2476 683936 112602 62690008
Drug abuse 419.90 10.85 1725 684687 70793 62731817
Intentional overdose 415.35 10.85 1746 684666 72406 62730204
Urticaria 412.41 10.85 3137 683275 162665 62639945
Acute hepatic failure 394.49 10.85 710 685702 17617 62784993
Intentional product misuse 383.92 10.85 1488 684924 59429 62743181
Pruritus 310.37 10.85 5560 680852 355893 62446717
Muscle injury 307.43 10.85 1461 684951 63884 62738726
Flushing 298.54 10.85 1601 684811 73486 62729124
Drug ineffective 295.86 10.85 8829 677583 1035936 61766674
Folliculitis 293.77 10.85 1520 684892 68797 62733813
Injection site pain 284.74 10.85 611 685801 129189 62673421
Device expulsion 266.67 10.85 32 686380 34890 62767720
Irritable bowel syndrome 259.98 10.85 1653 684759 80759 62721851
Product dose omission issue 259.17 10.85 1479 684933 232834 62569776
Throat irritation 252.35 10.85 938 685474 36709 62765901
Lower respiratory tract infection 250.17 10.85 2355 684057 129952 62672658
Respiratory arrest 249.34 10.85 849 685563 31796 62770814
Anaemia 231.28 10.85 2043 684369 291387 62511223
Cardio-respiratory arrest 231.26 10.85 1268 685144 58691 62743919
Impaired healing 223.04 10.85 1882 684530 100660 62701950
Diarrhoea 214.60 10.85 5994 680418 709372 62093238
Metabolic acidosis 214.38 10.85 1011 685401 44058 62758552
Nasopharyngitis 213.64 10.85 3899 682513 250358 62552252
Cardiac failure 203.56 10.85 410 686002 88732 62713878
Ill-defined disorder 199.77 10.85 1541 684871 80214 62722396
Intentional product use issue 198.89 10.85 2187 684225 125705 62676905
Analgesic drug level increased 198.36 10.85 181 686231 2191 62800419
Sleep disorder due to general medical condition, insomnia type 197.17 10.85 1098 685314 51119 62751491
Blood pressure systolic increased 196.85 10.85 1023 685389 46374 62756236
Anion gap 196.53 10.85 141 686271 1176 62801434
Blister 195.11 10.85 2205 684207 127609 62675001
Oxygen saturation decreased 194.84 10.85 1630 684782 86955 62715655
Blood pressure diastolic abnormal 187.92 10.85 457 685955 14085 62788525
Hepatic cytolysis 187.29 10.85 473 685939 14934 62787676
Hypersensitivity 185.81 10.85 4306 682106 288379 62514231
Blood pressure increased 185.61 10.85 2617 683795 159445 62643165
Cardiac failure congestive 184.21 10.85 458 685954 91975 62710635
Infusion site pain 171.81 10.85 485 685927 16384 62786226
Drug interaction 171.02 10.85 1617 684795 227514 62575096
Body temperature increased 170.86 10.85 826 685586 36366 62766244
Rheumatoid arthritis 168.47 10.85 3758 682654 250061 62552549
Neutropenia 163.46 10.85 1163 685249 173842 62628768
Blood pressure systolic abnormal 160.68 10.85 409 686003 12977 62789633
Helicobacter infection 159.39 10.85 1619 684793 91166 62711444
Duodenal ulcer perforation 156.71 10.85 1536 684876 85673 62716937
Hepatotoxicity 156.25 10.85 803 685609 36238 62766372
Malignant neoplasm progression 155.88 10.85 417 685995 81704 62720906
Exposure via ingestion 155.12 10.85 174 686238 2735 62799875
Psoriasis 154.38 10.85 456 685956 86501 62716109
Heart rate decreased 153.77 10.85 930 685482 44630 62757980
Wrong technique in product usage process 152.58 10.85 275 686137 62065 62740545
Heart rate increased 151.79 10.85 1623 684789 92615 62709995
Acute kidney injury 148.75 10.85 1980 684432 261435 62541175
Renal impairment 139.64 10.85 488 685924 87867 62714743
Infusion site swelling 139.24 10.85 319 686093 9451 62793159
Injection site erythema 139.24 10.85 448 685964 82726 62719884
Medication error 134.72 10.85 998 685414 51286 62751324
Pancytopenia 133.48 10.85 566 685846 96367 62706243
Urine abnormality 132.41 10.85 257 686155 6762 62795848
Sopor 129.85 10.85 39 686373 22125 62780485
Poisoning 125.24 10.85 379 686033 13321 62789289
Osteonecrosis of jaw 125.04 10.85 117 686295 35006 62767604
Blood pressure diastolic decreased 125.00 10.85 532 685880 22174 62780436
Hospitalisation 124.56 10.85 485 685927 84596 62718014
Throat tightness 123.29 10.85 565 685847 24322 62778288
Drug resistance 121.15 10.85 48 686364 22885 62779725
Injection site bruising 120.48 10.85 166 686246 41744 62760866
Weight increased 119.67 10.85 3678 682734 257114 62545496
Infusion site erythema 119.15 10.85 336 686076 11343 62791267
Infusion site extravasation 118.39 10.85 312 686100 10114 62792496
Therapy cessation 117.49 10.85 94 686318 30363 62772247
Urine leukocyte esterase positive 117.38 10.85 168 686244 3411 62799199
Pericarditis 116.44 10.85 2035 684377 129544 62673066
Hereditary angioedema 112.33 10.85 251 686161 7311 62795299
Anti-cyclic citrullinated peptide antibody positive 110.72 10.85 1819 684593 114393 62688217
Suicide attempt 110.42 10.85 1075 685337 59843 62742767
Synovitis 107.87 10.85 2715 683697 184203 62618407
Hyperkalaemia 107.64 10.85 269 686143 53934 62748676
Hepatic enzyme increased 106.96 10.85 2905 683507 199423 62603187
Stomatitis 106.92 10.85 2100 684312 136625 62665985
Gastrointestinal disorder 105.34 10.85 1999 684413 129240 62673370
Infusion site pruritus 103.08 10.85 212 686200 5823 62796787
Therapeutic product effect incomplete 102.67 10.85 861 685551 124195 62678415
Hyponatraemia 101.83 10.85 749 685663 111151 62691459
Myocardial infarction 101.63 10.85 647 685765 99246 62703364
Poor venous access 101.25 10.85 371 686041 14414 62788196
Disease progression 100.41 10.85 846 685566 121912 62680698
Depressed level of consciousness 97.55 10.85 1064 685348 61014 62741596
Thrombocytopenia 96.63 10.85 1106 685306 150051 62652559
Renal failure 93.46 10.85 817 685595 116835 62685775
Abortion spontaneous 93.11 10.85 235 686177 46960 62755650
Product substitution issue 90.40 10.85 30 686382 15966 62786644
Food allergy 90.13 10.85 300 686112 11101 62791509
Interstitial lung disease 89.91 10.85 354 686058 61554 62741056
Peripheral swelling 89.47 10.85 3620 682792 262322 62540288
Anticholinergic syndrome 87.37 10.85 118 686294 2264 62800346
Ear pruritus 87.10 10.85 155 686257 3810 62798800
Sedation complication 86.51 10.85 337 686075 13485 62789125
Neoplasm progression 86.20 10.85 164 686248 36264 62766346
Suspected suicide 81.25 10.85 203 686209 6365 62796245
Cerebrovascular accident 80.21 10.85 763 685649 107261 62695349
Therapeutic product effect decreased 79.80 10.85 2691 683721 190496 62612114
Joint swelling 78.33 10.85 4311 682101 323355 62479255
Chest discomfort 78.19 10.85 1645 684767 108324 62694286
Ear infection 76.59 10.85 689 685723 37524 62765086
Neuropathy peripheral 76.07 10.85 823 685589 112844 62689766
Foetal exposure during pregnancy 75.54 10.85 144 686268 31818 62770792
Ear pain 75.37 10.85 657 685755 35461 62767149
Product storage error 74.69 10.85 34 686378 14922 62787688
Coagulopathy 73.58 10.85 426 685986 20118 62782492
Therapy interrupted 73.44 10.85 150 686262 32305 62770305
Crystal urine present 73.33 10.85 90 686322 1564 62801046
White blood cells urine positive 73.05 10.85 168 686244 4990 62797620
Respiratory failure 72.86 10.85 726 685686 101132 62701478
Diabetes mellitus 72.50 10.85 333 686079 55477 62747133
Discomfort 72.34 10.85 2344 684068 165030 62637580
Poisoning deliberate 72.25 10.85 276 686136 10942 62791668
Posterior reversible encephalopathy syndrome 71.45 10.85 50 686362 17295 62785315
Urinary sediment present 70.19 10.85 102 686310 2101 62800509
Pharyngitis 69.76 10.85 414 685998 19729 62782881
Leukopenia 69.51 10.85 519 685893 76771 62725839
Bone marrow failure 69.19 10.85 132 686280 29158 62773452
Fall 69.02 10.85 3502 682910 388832 62413778
Deafness transitory 68.35 10.85 95 686317 1875 62800735
Full blood count abnormal 67.27 10.85 152 686260 31565 62771045
Lymphocyte count decreased 67.15 10.85 558 685854 29699 62772911
Pulmonary hypertension 67.08 10.85 193 686219 36930 62765680
Device dislocation 66.91 10.85 109 686303 25596 62777014
Inappropriate schedule of product administration 66.86 10.85 1533 684879 102432 62700178
Creatinine renal clearance decreased 66.32 10.85 350 686062 15958 62786652
Oedema peripheral 66.28 10.85 1551 684861 187960 62614650
Acute lung injury 65.67 10.85 83 686329 1488 62801122
Device malfunction 65.33 10.85 58 686354 17799 62784811
Atrial fibrillation 65.26 10.85 878 685534 115758 62686852
Anaphylactic reaction 64.55 10.85 1039 685373 65061 62737549
Product prescribing error 64.29 10.85 116 686296 26173 62776437
Pyroglutamic acidosis 64.24 10.85 54 686358 581 62802029
Temperature regulation disorder 63.12 10.85 177 686235 5955 62796655
Rash 61.97 10.85 6947 679465 553924 62248686
Respiratory rate increased 61.87 10.85 302 686110 13346 62789264
Erythema 61.53 10.85 2403 684009 173348 62629262
Pneumonia 61.38 10.85 4183 682229 452584 62350026
No adverse event 61.24 10.85 235 686177 41170 62761440
Tachycardia 60.83 10.85 1691 684721 116465 62686145
Pulmonary arterial hypertension 60.41 10.85 94 686318 22483 62780127
Syncope 60.25 10.85 899 685513 116486 62686124
Blood pressure diastolic increased 60.18 10.85 241 686171 9769 62792841
Septic shock 60.11 10.85 447 685965 66182 62736428
Accidental overdose 60.07 10.85 445 685967 22864 62779746
Injury 59.87 10.85 1119 685293 72128 62730482
Lactic acidosis 59.45 10.85 213 686199 38074 62764536
Hypokalaemia 57.86 10.85 782 685630 103022 62699588
Red blood cells urine positive 57.20 10.85 113 686299 3013 62799597
Gastrointestinal haemorrhage 57.05 10.85 581 685831 80595 62722015
Infusion site bruising 56.70 10.85 127 686285 3705 62798905
Swelling 56.61 10.85 3575 682837 271803 62530807
Breast cancer stage I 55.98 10.85 5 686407 6884 62795726
Haematotoxicity 55.84 10.85 16 686396 9360 62793250
Heart rate irregular 54.94 10.85 423 685989 21998 62780612
Chills 54.86 10.85 1610 684802 111768 62690842
Hepatic necrosis 54.51 10.85 160 686252 5527 62797083
Epilepsy 53.98 10.85 134 686278 26931 62775679
Muscle spasticity 53.87 10.85 412 686000 21382 62781228
Myelodysplastic syndrome 53.76 10.85 61 686351 16693 62785917
Infection 53.68 10.85 3010 683402 226163 62576447
Visual acuity reduced 53.65 10.85 96 686316 21730 62780880
Injection site reaction 53.57 10.85 391 686021 58133 62744477
Respiratory depression 53.49 10.85 291 686121 13424 62789186
Dyspnoea exertional 53.24 10.85 407 686005 59895 62742715
Breast cancer 53.06 10.85 306 686106 48077 62754533
Surgery 53.00 10.85 204 686208 35708 62766902
Hypocalcaemia 52.93 10.85 171 686241 31542 62771068
Blood calcium decreased 52.02 10.85 475 685937 25976 62776634
Cytomegalovirus infection 51.64 10.85 92 686320 20860 62781750
Premature delivery 51.43 10.85 162 686250 30119 62772491
Sepsis 51.10 10.85 1262 685150 151861 62650749
Cardiac arrest 50.91 10.85 1336 685076 91209 62711401
Diabetic ketoacidosis 50.57 10.85 90 686322 20415 62782195
Dehydration 50.20 10.85 1458 684954 171896 62630714
Osteonecrosis 50.06 10.85 120 686292 24410 62778200
Pyrexia 49.95 10.85 5813 680599 464665 62337945
Myelosuppression 49.94 10.85 114 686298 23589 62779021
Pyroglutamate increased 49.85 10.85 40 686372 401 62802209
Body temperature decreased 49.60 10.85 383 686029 19936 62782674
Product quality issue 48.99 10.85 210 686202 35655 62766955
Device difficult to use 48.72 10.85 40 686372 12756 62789854
Infusion site haemorrhage 48.66 10.85 143 686269 4943 62797667
Multiple organ dysfunction syndrome 48.25 10.85 387 686025 56365 62746245
Pneumocystis jirovecii pneumonia 47.61 10.85 68 686344 16846 62785764
Hypertensive crisis 47.60 10.85 57 686355 15229 62787381
Anion gap abnormal 47.59 10.85 38 686374 378 62802232
Right ventricular failure 47.50 10.85 70 686342 17118 62785492
Incorrect drug administration rate 47.49 10.85 121 686291 3841 62798769
White blood cell count decreased 46.81 10.85 1145 685267 137959 62664651
Chronic kidney disease 46.69 10.85 293 686119 45105 62757505
Pathogen resistance 46.14 10.85 7 686405 6391 62796219
Breast cancer female 46.14 10.85 47 686365 13512 62789098
Polyneuropathy 45.86 10.85 54 686358 14535 62788075
Injection site haemorrhage 45.71 10.85 124 686288 24190 62778420
Injection site pruritus 45.47 10.85 293 686119 44823 62757787
Lymphocyte percentage decreased 45.37 10.85 100 686312 2885 62799725
Coronary artery disease 45.20 10.85 188 686224 32189 62770421
Platelet count decreased 44.68 10.85 936 685476 115186 62687424
Osteoarthritis 44.61 10.85 743 685669 94600 62708010
Transient ischaemic attack 44.56 10.85 233 686179 37520 62765090
Rheumatic fever 44.49 10.85 684 685728 42427 62760183
Full blood count decreased 43.66 10.85 140 686272 25884 62776726
Electric shock 43.34 10.85 62 686350 1258 62801352
Hepatic failure 43.27 10.85 582 685830 35074 62767536
Blood urine present 43.08 10.85 295 686117 14774 62787836
Labelled drug-drug interaction medication error 42.76 10.85 49 686363 13350 62789260
Postmortem blood drug level increased 42.70 10.85 42 686370 562 62802048
Cholecystitis chronic 42.57 10.85 223 686189 10138 62792472
Decreased appetite 42.34 10.85 2250 684162 248802 62553808
COVID-19 41.35 10.85 1554 684858 111549 62691061
Palmar-plantar erythrodysaesthesia syndrome 41.33 10.85 120 686292 22895 62779715
Injection site swelling 41.09 10.85 323 686089 47249 62755361
Gastrooesophageal reflux disease 41.00 10.85 757 685655 94882 62707728
Weight fluctuation 40.80 10.85 212 686200 9607 62793003
Neutrophil percentage increased 40.74 10.85 95 686317 2848 62799762
Infusion site mass 40.58 10.85 77 686335 1991 62800619
Metastases to bone 40.42 10.85 106 686306 20913 62781697
Renal disorder 40.34 10.85 201 686211 32773 62769837
Cognitive disorder 40.33 10.85 837 685575 54978 62747632
Thrombotic microangiopathy 40.22 10.85 33 686379 10528 62792082
Hyperglycaemia 40.13 10.85 276 686136 41591 62761019
Blood glucose increased 39.41 10.85 652 685760 83104 62719506
Urine ketone body present 39.35 10.85 85 686327 2418 62800192
Unevaluable event 38.96 10.85 361 686051 51025 62751585
Alopecia 38.57 10.85 3133 683279 334403 62468207
Cardiac failure acute 38.50 10.85 28 686384 9495 62793115
Pharyngeal paraesthesia 38.43 10.85 74 686338 1935 62800675
Cerebral haemorrhage 38.35 10.85 186 686226 30543 62772067
Second primary malignancy 38.30 10.85 19 686393 7934 62794676
Transplant rejection 38.26 10.85 36 686376 10744 62791866
Administration site swelling 38.03 10.85 58 686354 1249 62801361
Suicidal ideation 37.82 10.85 462 685950 61959 62740651
Immunodeficiency 37.47 10.85 359 686053 19895 62782715
Post transplant lymphoproliferative disorder 37.46 10.85 5 686407 5026 62797584
Mucosal inflammation 37.19 10.85 326 686086 46602 62756008
Depression 36.99 10.85 1741 684671 194751 62607859
Hepatic cirrhosis 36.82 10.85 140 686272 24594 62778016
Hypothyroidism 36.57 10.85 290 686122 42342 62760268
Accidental exposure to product 36.50 10.85 162 686250 27243 62775367
Memory impairment 36.49 10.85 853 685559 103405 62699205
Swollen joint count increased 36.43 10.85 570 685842 35484 62767126
Body temperature fluctuation 36.39 10.85 78 686334 2207 62800403
Infusion site nodule 36.27 10.85 61 686351 1431 62801179
Systemic infection 36.25 10.85 4 686408 4656 62797954
Red cell distribution width increased 36.25 10.85 216 686196 10308 62792302
Sexual dysfunction 35.87 10.85 3 686409 4356 62798254
Cerebral infarction 35.73 10.85 135 686277 23758 62778852
Feeling hot 35.69 10.85 753 685659 49601 62753009
Maternal exposure during pregnancy 35.66 10.85 1980 684432 218082 62584528
Accidental death 35.64 10.85 71 686341 1905 62800705
Hand deformity 35.51 10.85 2085 684327 157372 62645238
Injection site warmth 35.43 10.85 69 686343 15126 62787484
Disease recurrence 35.37 10.85 169 686243 27861 62774749
Drug dose omission by device 35.21 10.85 5 686407 4796 62797814
Infusion site rash 35.19 10.85 71 686341 1923 62800687
Agranulocytosis 35.05 10.85 146 686266 24988 62777622
Mobility decreased 35.03 10.85 1624 684788 119535 62683075
Ischaemic stroke 34.96 10.85 90 686322 17867 62784743
Inappropriate antidiuretic hormone secretion 34.53 10.85 72 686340 15390 62787220
Treatment noncompliance 34.33 10.85 249 686163 37076 62765534
Drug use disorder 34.07 10.85 125 686287 4859 62797751
Headache 33.79 10.85 7534 678878 625707 62176903
Arthralgia 33.72 10.85 6812 679600 562898 62239712
Unintentional medical device removal 33.64 10.85 12 686400 6103 62796507
Therapeutic response shortened 33.55 10.85 232 686180 11656 62790954
Gestational diabetes 33.54 10.85 25 686387 8371 62794239
Haemorrhage 33.17 10.85 462 685950 60560 62742050
Ascites 33.13 10.85 281 686131 40447 62762163
Night sweats 33 10.85 725 685687 48089 62754521
Mydriasis 32.97 10.85 232 686180 11724 62790886
Pneumonia viral 32.89 10.85 171 686241 7751 62794859
Oral pruritus 32.86 10.85 75 686337 2216 62800394
Acute myeloid leukaemia 32.57 10.85 87 686325 17060 62785550
Metastases to liver 32.54 10.85 138 686274 23501 62779109
Bursitis 32.41 10.85 572 685840 36469 62766141
Multiple-drug resistance 32.35 10.85 8 686404 5162 62797448
Injection site mass 32.25 10.85 99 686313 18557 62784053
Specific gravity urine decreased 32.19 10.85 41 686371 741 62801869
Exposure during pregnancy 31.96 10.85 1365 685047 154182 62648428
Plasma cell myeloma 31.85 10.85 242 686170 35663 62766947
Neurotoxicity 31.68 10.85 87 686325 16903 62785707
Febrile bone marrow aplasia 31.67 10.85 20 686392 7305 62795305
Therapeutic response decreased 31.62 10.85 471 685941 61054 62741556
Hypomania 31.56 10.85 144 686268 6186 62796424
Gait disturbance 31.56 10.85 1638 684774 181540 62621070
Muscle spasms 31.53 10.85 1373 685039 154777 62647833
Acute myocardial infarction 31.17 10.85 211 686201 31913 62770697
Infusion site discomfort 31.09 10.85 56 686356 1390 62801220
Epistaxis 31.05 10.85 576 685836 72149 62730461
Injection site rash 30.98 10.85 102 686310 18707 62783903
C-reactive protein abnormal 30.96 10.85 684 685728 45412 62757198
Coma 30.31 10.85 911 685501 63453 62739157
Electrolyte imbalance 30.30 10.85 113 686299 19963 62782647
Hyperlipidaemia 29.64 10.85 110 686302 19461 62783149
Transplant dysfunction 29.60 10.85 8 686404 4864 62797746
Vaginal haemorrhage 29.52 10.85 175 686237 27312 62775298
Complication associated with device 29.42 10.85 90 686322 16888 62785722
Hip fracture 29.40 10.85 192 686220 29282 62773328
Schizoaffective disorder 29.29 10.85 95 686317 3467 62799143
Bone erosion 29.24 10.85 96 686316 17621 62784989
Product use in unapproved indication 29.23 10.85 1610 684802 177470 62625140
Contusion 29.17 10.85 1939 684473 148105 62654505
Arthropathy 29.01 10.85 2931 683481 231861 62570749
Abortion induced 29 10.85 41 686371 10201 62792409
Confusional state 28.95 10.85 2949 683463 233431 62569179
Atypical femur fracture 28.78 10.85 11 686401 5361 62797249
Incorrect dose administered by device 28.66 10.85 6 686406 4342 62798268
Cytokine release syndrome 28.63 10.85 258 686154 14056 62788554
Intentional self-injury 28.41 10.85 162 686250 25525 62777085
Infusion site urticaria 28.37 10.85 57 686355 1539 62801071
Complication of device insertion 28.36 10.85 24 686388 7540 62795070
Hypotension 28.29 10.85 3364 683048 269240 62533370
Spinal stenosis 28.15 10.85 76 686336 14849 62787761
Brain death 28.09 10.85 91 686321 3319 62799291
Electrocardiogram QRS complex prolonged 28.08 10.85 133 686279 5805 62796805
Rash erythematous 27.99 10.85 629 685783 41881 62760729
Administration site pain 27.88 10.85 40 686372 814 62801796
Sleep disorder due to a general medical condition 27.86 10.85 56 686356 12132 62790478
Myalgia 27.83 10.85 1297 685115 145232 62657378
Fracture 27.78 10.85 113 686299 19471 62783139
Haemophagocytic lymphohistiocytosis 27.72 10.85 45 686367 10582 62792028
Haemoglobin urine present 27.53 10.85 39 686373 784 62801826
Hepatocellular injury 27.50 10.85 178 686234 27203 62775407
Pleural effusion 27.45 10.85 782 685630 92428 62710182
Anion gap increased 27.43 10.85 62 686350 1820 62800790
Lung neoplasm malignant 27.40 10.85 114 686298 19519 62783091
Device use error 27.39 10.85 14 686398 5747 62796863
Vision blurred 27.38 10.85 770 685642 91154 62711456
Culture urine positive 27.37 10.85 95 686317 3592 62799018
Heart rate abnormal 27.29 10.85 116 686296 4831 62797779
Wound 27.29 10.85 2084 684328 161179 62641431
Seizure 27.23 10.85 1164 685248 131470 62671140
Metastases to lung 27.12 10.85 61 686351 12689 62789921
Jaundice cholestatic 26.96 10.85 153 686259 7171 62795439
Sedation 26.42 10.85 577 685835 38232 62764378
Intermenstrual bleeding 26.38 10.85 28 686384 7898 62794712
Device issue 26.29 10.85 150 686262 23631 62778979
Colorectal cancer 26.26 10.85 4 686408 3641 62798969
Bronchopulmonary aspergillosis 26.04 10.85 33 686379 8602 62794008
Endophthalmitis 25.74 10.85 4 686408 3588 62799022
Seasonal allergy 25.44 10.85 342 686070 20608 62782002
Soft tissue disorder 25.42 10.85 105 686307 4317 62798293
Mitral valve incompetence 25.39 10.85 117 686295 19477 62783133
Pancreatic carcinoma 25.32 10.85 27 686385 7601 62795009
Cardiac disorder 25.09 10.85 392 686020 50424 62752186
Upper respiratory tract infection 24.85 10.85 1105 685307 80942 62721668
Subdural haematoma 24.79 10.85 76 686336 14252 62788358
Extrapyramidal disorder 24.78 10.85 68 686344 13216 62789394
Chronic obstructive pulmonary disease 24.78 10.85 503 685909 62183 62740427
Bacterial test 24.65 10.85 45 686367 1129 62801481
Acute respiratory failure 24.56 10.85 246 686166 34239 62768371
Bacterial test positive 24.46 10.85 118 686294 5189 62797421
Ventricular fibrillation 24.26 10.85 58 686354 11809 62790801
Urine analysis abnormal 24.19 10.85 113 686299 4903 62797707
Brain oedema 24.02 10.85 247 686165 13948 62788662
Personality change 23.92 10.85 24 686388 6949 62795661
Alanine aminotransferase increased 23.88 10.85 1361 685051 102409 62700201
Toxicologic test abnormal 23.87 10.85 34 686378 687 62801923
Anticipatory anxiety 23.83 10.85 46 686366 1205 62801405
Cardiotoxicity 23.67 10.85 34 686378 8404 62794206
Ageusia 23.63 10.85 73 686339 13655 62788955
Respiratory disorder 23.49 10.85 571 685841 38511 62764099
Orthostatic hypotension 23.48 10.85 534 685878 35626 62766984
Serum sickness 23.27 10.85 76 686336 2784 62799826
Immune reconstitution inflammatory syndrome 23.18 10.85 19 686393 6065 62796545
Mast cell activation syndrome 23.15 10.85 36 686376 789 62801821
Product monitoring error 22.97 10.85 10 686402 4506 62798104
Kidney infection 22.88 10.85 365 686047 22811 62779799
Unresponsive to stimuli 22.78 10.85 502 685910 33314 62769296
Metastases to lymph nodes 22.76 10.85 33 686379 8125 62794485
Pain in jaw 22.69 10.85 332 686080 43164 62759446
Infusion site irritation 22.58 10.85 38 686374 892 62801718
Dysgeusia 22.50 10.85 362 686050 46348 62756262
Drug withdrawal syndrome 22.40 10.85 187 686225 27007 62775603
Macular oedema 22.39 10.85 7 686405 3870 62798740
Blood iron abnormal 22.38 10.85 7 686405 3869 62798741
Metastases to central nervous system 22.33 10.85 70 686342 13035 62789575
Psoriatic arthropathy 22.32 10.85 787 685625 90733 62711877
Catheter site bruise 22.23 10.85 27 686385 464 62802146
Blood pH decreased 22.19 10.85 70 686342 2517 62800093
Opiates positive 22.16 10.85 24 686388 362 62802248
Carpal tunnel syndrome 22.11 10.85 133 686279 20684 62781926
Gastrointestinal pain 22.07 10.85 181 686231 9595 62793015
Meningitis aseptic 22.06 10.85 107 686305 4716 62797894
Administration site bruise 21.90 10.85 25 686387 401 62802209
Drug ineffective for unapproved indication 21.83 10.85 249 686163 33814 62768796
Visual impairment 21.80 10.85 721 685691 83725 62718885
Rheumatoid factor positive 21.80 10.85 1119 685293 83287 62719323
Low turnover osteopathy 21.71 10.85 9 686403 4176 62798434
Compartment syndrome 21.65 10.85 64 686348 2220 62800390
Drug level below therapeutic 21.58 10.85 107 686305 4759 62797851
Analgesic drug level above therapeutic 21.54 10.85 17 686395 166 62802444
Somnolence 21.54 10.85 2227 684185 176458 62626152
Galactorrhoea 21.45 10.85 9 686403 4146 62798464
Bone pain 21.43 10.85 439 685973 54202 62748408
Graft versus host disease in skin 21.36 10.85 3 686409 2902 62799708
Hepatic function abnormal 21.34 10.85 278 686134 36864 62765746
Coeliac disease 21.33 10.85 222 686190 12575 62790035
Systemic lupus erythematosus rash 21.24 10.85 63 686349 2189 62800421
Vitamin K deficiency 21.24 10.85 25 686387 415 62802195
Chronic graft versus host disease 21.03 10.85 4 686408 3098 62799512
Iron deficiency anaemia 20.99 10.85 128 686284 19841 62782769
Diffuse large B-cell lymphoma 20.93 10.85 25 686387 6687 62795923
Large intestine polyp 20.85 10.85 35 686377 8122 62794488
Substance abuse 20.82 10.85 105 686307 4702 62797908
Insurance issue 20.68 10.85 125 686287 5996 62796614
Cardiac failure chronic 20.61 10.85 11 686401 4407 62798203
Injection site induration 20.57 10.85 43 686369 9183 62793427
Invasive ductal breast carcinoma 20.56 10.85 27 686385 6931 62795679
Neutrophil count decreased 20.43 10.85 459 685953 55947 62746663
Pneumonia aspiration 20.41 10.85 257 686155 34283 62768327
Congestive cardiomyopathy 20.39 10.85 22 686390 6160 62796450
Dizziness 20.39 10.85 4221 682191 425704 62376906
Therapeutic response unexpected 20.37 10.85 119 686293 18640 62783970
Ketoacidosis 20.28 10.85 11 686401 4367 62798243
Product adhesion issue 20.25 10.85 13 686399 4706 62797904
Graft versus host disease 20.24 10.85 26 686386 6737 62795873
Left ventricular failure 20.17 10.85 19 686393 5668 62796942
Hypervolaemia 20.10 10.85 203 686209 28210 62774400
Blood loss anaemia 20.03 10.85 42 686370 8959 62793651
Drug screen positive 19.95 10.85 85 686327 3544 62799066
Product residue present 19.94 10.85 9 686403 3970 62798640
Pharyngeal swelling 19.90 10.85 128 686284 6276 62796334
Serum sickness-like reaction 19.84 10.85 26 686386 484 62802126
Amenorrhoea 19.83 10.85 49 686363 9865 62792745
Sensitisation 19.76 10.85 6 686406 3380 62799230
Rhabdomyolysis 19.74 10.85 345 686067 43606 62759004
Infective pulmonary exacerbation of cystic fibrosis 19.74 10.85 41 686371 8776 62793834
Complication of device removal 19.67 10.85 16 686396 5126 62797484
Human herpesvirus 6 infection 19.66 10.85 4 686408 2953 62799657
Device leakage 19.51 10.85 29 686383 7067 62795543
Hypoglycaemia 19.49 10.85 497 685915 59568 62743042
Low density lipoprotein increased 19.48 10.85 24 686388 6333 62796277
Thinking abnormal 19.47 10.85 55 686357 10588 62792022
Aphasia 19.33 10.85 246 686166 32754 62769856
Unintended pregnancy 19.28 10.85 23 686389 6156 62796454
Varicella zoster virus infection 19.26 10.85 3 686409 2686 62799924
Genital haemorrhage 19.17 10.85 31 686381 7301 62795309
Migraine 19.10 10.85 1330 685082 102016 62700594
Obstructive airways disorder 19.08 10.85 138 686274 20561 62782049
Prothrombin time shortened 19.00 10.85 56 686356 1939 62800671
Multiple drug therapy 18.97 10.85 84 686328 3562 62799048
Dyskinesia 18.95 10.85 238 686174 31764 62770846
Loss of consciousness 18.89 10.85 1064 685348 117057 62685553
Skin toxicity 18.88 10.85 14 686398 4700 62797910
Nitrite urine present 18.86 10.85 38 686374 1028 62801582
Specific gravity urine increased 18.81 10.85 17 686395 203 62802407
Cytomegalovirus viraemia 18.75 10.85 20 686392 5629 62796981
Haematuria 18.74 10.85 213 686199 28944 62773666
Aspergillus infection 18.65 10.85 37 686375 8056 62794554
Heavy menstrual bleeding 18.64 10.85 114 686298 17659 62784951
Akathisia 18.46 10.85 45 686367 9101 62793509
Left ventricular dysfunction 18.40 10.85 67 686345 11921 62790689
Epstein-Barr virus infection 18.39 10.85 37 686375 8013 62794597
Infusion site warmth 18.25 10.85 52 686360 1766 62800844
Spinal fracture 18.23 10.85 119 686293 18152 62784458
Oropharyngeal pain 18.17 10.85 1220 685192 93267 62709343
Periorbital swelling 18.14 10.85 71 686341 2847 62799763
Anuria 18.07 10.85 72 686340 12479 62790131
Anosognosia 18.05 10.85 6 686406 3190 62799420
Treatment failure 18.01 10.85 1880 684532 197163 62605447
Acute graft versus host disease 17.93 10.85 13 686399 4415 62798195
Multiple allergies 17.88 10.85 228 686184 13574 62789036
Tongue disorder 17.86 10.85 184 686228 10396 62792214
Cardiomyopathy 17.81 10.85 114 686298 17470 62785140
Skin cancer 17.81 10.85 64 686348 11431 62791179
Drug-induced liver injury 17.79 10.85 565 685847 39657 62762953
Uterine cancer 17.77 10.85 15 686397 4718 62797892
Shoulder arthroplasty 17.74 10.85 88 686324 3914 62798696
Drug specific antibody present 17.73 10.85 92 686320 4167 62798443
Cytopenia 17.70 10.85 65 686347 11536 62791074
Angina unstable 17.62 10.85 31 686381 7064 62795546
Melaena 17.55 10.85 227 686185 30138 62772472
Oropharyngeal discomfort 17.50 10.85 107 686305 5153 62797457
Cardiovascular disorder 17.49 10.85 67 686345 11745 62790865
Concomitant disease aggravated 17.49 10.85 46 686366 9066 62793544
Thyroid cancer 17.39 10.85 21 686391 5590 62797020
Movement disorder 17.37 10.85 150 686262 21511 62781099
Emotional distress 17.35 10.85 468 685944 32081 62770529
General physical health deterioration 17.33 10.85 1909 684503 199493 62603117
Ovarian hyperstimulation syndrome 17.30 10.85 11 686401 4003 62798607
Pericardial effusion 17.26 10.85 225 686187 29833 62772777
Forced expiratory volume decreased 17.16 10.85 17 686395 4951 62797659
Femoral neck fracture 17.15 10.85 42 686370 8481 62794129
Injection site discolouration 17.14 10.85 37 686375 7811 62794799
Multiple sclerosis relapse 17.13 10.85 396 686016 48082 62754528
Aplasia pure red cell 17.11 10.85 14 686398 4473 62798137
Vein rupture 17.07 10.85 40 686372 1203 62801407
Coagulation factor X level decreased 16.99 10.85 11 686401 76 62802534
Cystitis 16.96 10.85 742 685670 54249 62748361
Product complaint 16.89 10.85 76 686336 12733 62789877
Myopathy 16.88 10.85 63 686349 11128 62791482
Status epilepticus 16.88 10.85 96 686316 15137 62787473
Device breakage 16.75 10.85 66 686346 11476 62791134
Hypocoagulable state 16.75 10.85 39 686373 1168 62801442
Brain stem glioma 16.74 10.85 15 686397 177 62802433
Lung adenocarcinoma 16.73 10.85 15 686397 4582 62798028
Cellulitis 16.66 10.85 720 685692 81238 62721372
Small for dates baby 16.55 10.85 10 686402 3741 62798869
Hypomagnesaemia 16.54 10.85 215 686197 28522 62774088
Peritonitis 16.48 10.85 113 686299 17041 62785569
Vascular rupture 16.46 10.85 48 686364 1652 62800958
Device deployment issue 16.40 10.85 11 686401 3891 62798719
Spinal compression fracture 16.38 10.85 89 686323 14194 62788416
Tricuspid valve incompetence 16.28 10.85 92 686320 14529 62788081
Infusion site streaking 16.28 10.85 24 686388 501 62802109
Ventricular arrhythmia 16.15 10.85 83 686329 3745 62798865
Pre-eclampsia 16.12 10.85 48 686364 9085 62793525
Blood creatinine decreased 16.12 10.85 109 686303 5436 62797174
Asthenia 16.04 10.85 3789 682623 379815 62422795
Dysphoria 16.02 10.85 18 686394 4948 62797662
Meniscus injury 15.99 10.85 33 686379 7081 62795529
Adrenergic syndrome 15.97 10.85 8 686404 31 62802579
Joint stiffness 15.94 10.85 338 686074 41531 62761079
Tremor 15.91 10.85 1222 685190 131017 62671593
Perfume sensitivity 15.83 10.85 30 686382 775 62801835
Intervertebral discitis 15.77 10.85 73 686339 3155 62799455
Lumbar vertebral fracture 15.73 10.85 24 686388 5786 62796824
Prescribed overdose 15.70 10.85 482 685930 33671 62768939
Body height decreased 15.69 10.85 56 686356 10022 62792588
Immunosuppressant drug level increased 15.64 10.85 10 686402 3628 62798982
Focal dyscognitive seizures 15.62 10.85 6 686406 2915 62799695
Lactobacillus infection 15.60 10.85 9 686403 49 62802561
Coagulation factor VII level decreased 15.60 10.85 11 686401 89 62802521
Long QT syndrome 15.54 10.85 8 686404 3271 62799339
Blood potassium decreased 15.50 10.85 341 686071 41685 62760925
Infusion site induration 15.36 10.85 38 686374 1184 62801426
Abnormal dreams 15.35 10.85 60 686352 10456 62792154
Patent ductus arteriosus 15.31 10.85 14 686398 4236 62798374
Secondary amyloidosis 15.30 10.85 12 686400 116 62802494
Secretion discharge 15.28 10.85 74 686338 12157 62790453
Oesophageal carcinoma 15.24 10.85 4 686408 2480 62800130
Mucormycosis 15.18 10.85 6 686406 2865 62799745
Cachexia 15.17 10.85 24 686388 5702 62796908
Eosinophil percentage increased 15.11 10.85 34 686378 995 62801615
Dysstasia 15.07 10.85 151 686261 21015 62781595
Vertigo 15.06 10.85 513 685899 59374 62743236
Electric shock sensation 15.04 10.85 29 686383 759 62801851
Neuroleptic malignant syndrome 15.03 10.85 73 686339 11983 62790627
Caesarean section 15.01 10.85 115 686297 16917 62785693
Spinal pain 15.00 10.85 82 686330 13057 62789553
Inhibitory drug interaction 14.99 10.85 6 686406 2843 62799767
Granulocyte count increased 14.94 10.85 31 686381 857 62801753
Infusion site scar 14.89 10.85 23 686389 501 62802109
Anxiety 14.89 10.85 2621 683791 214920 62587690
Bundle branch block left 14.83 10.85 34 686378 7025 62795585
Vein collapse 14.78 10.85 34 686378 1010 62801600
Premature baby 14.73 10.85 148 686264 20587 62782023
Polycystic ovaries 14.65 10.85 16 686396 4455 62798155
Diastolic dysfunction 14.56 10.85 30 686382 6441 62796169
Nephropathy toxic 14.54 10.85 53 686359 9426 62793184
Sputum culture positive 14.52 10.85 54 686358 2113 62800497
Withdrawal syndrome 14.51 10.85 142 686270 19855 62782755
Ankylosing spondylitis 14.51 10.85 61 686351 10413 62792197
Haematocrit decreased 14.48 10.85 541 685871 38799 62763811
Ductus arteriosus premature closure 14.44 10.85 18 686394 318 62802292
Administration site erythema 14.42 10.85 28 686384 737 62801873
Thrombosis 14.41 10.85 563 685849 64192 62738418
Disorientation 14.30 10.85 321 686091 39131 62763479
Joint dislocation 14.28 10.85 132 686280 18668 62783942
Cystic fibrosis pancreatic 14.28 10.85 9 686403 59 62802551
Exostosis 14.19 10.85 124 686288 17738 62784872
Fluid retention 14.15 10.85 515 685897 59171 62743439
Physical disability 14.11 10.85 6 686406 2742 62799868
Disturbance in attention 14.05 10.85 310 686102 37879 62764731
Product physical issue 14.04 10.85 20 686392 4960 62797650
Dissociation 14.02 10.85 7 686405 2912 62799698
Hallucinations, mixed 14.00 10.85 19 686393 4810 62797800
Sleep apnoea syndrome 13.96 10.85 226 686186 28907 62773703
Normal newborn 13.90 10.85 45 686367 8296 62794314
Pulmonary tuberculosis 13.90 10.85 17 686395 4500 62798110
Malaise 13.84 10.85 4150 682262 411804 62390806
Potentiating drug interaction 13.82 10.85 16 686396 4340 62798270
Graft versus host disease in gastrointestinal tract 13.81 10.85 9 686403 3232 62799378
Blood cholesterol increased 13.72 10.85 1188 685224 92844 62709766
Monocyte percentage increased 13.70 10.85 35 686377 1113 62801497
Low birth weight baby 13.67 10.85 36 686376 7093 62795517
Arrhythmia 13.63 10.85 311 686101 37829 62764781
Lupus-like syndrome 13.60 10.85 103 686309 15192 62787418
Chondropathy 13.56 10.85 4 686408 2296 62800314
Angina pectoris 13.54 10.85 236 686176 29842 62772768
Post cholecystectomy syndrome 13.51 10.85 20 686392 419 62802191
Fibromyalgia 13.50 10.85 1027 685385 79393 62723217
Urinary casts 13.46 10.85 27 686385 728 62801882
Malignant melanoma 13.45 10.85 70 686342 11286 62791324
Circulatory collapse 13.43 10.85 162 686250 21776 62780834
Occupational exposure to product 13.43 10.85 3 686409 2075 62800535
Cells in urine 13.41 10.85 14 686398 202 62802408
Lymphoproliferative disorder 13.40 10.85 9 686403 3181 62799429
Pancreatitis 13.34 10.85 416 685996 48639 62753971
Coagulation factor decreased 13.33 10.85 10 686402 90 62802520
Squamous cell carcinoma of skin 13.32 10.85 29 686383 6103 62796507
Gastric cancer 13.28 10.85 19 686393 4704 62797906
Blood prolactin increased 13.27 10.85 11 686401 3492 62799118
Coronary arterial stent insertion 13.26 10.85 7 686405 2822 62799788
Device related thrombosis 13.26 10.85 46 686366 1739 62800871
Leukoencephalopathy 13.17 10.85 17 686395 4396 62798214
Administration site reaction 13.17 10.85 15 686397 240 62802370
Malnutrition 13.15 10.85 104 686308 15194 62787416
Catheter management 13.13 10.85 8 686404 2979 62799631
Embolism venous 13.11 10.85 9 686403 3145 62799465
Renal failure neonatal 13.10 10.85 13 686399 176 62802434
Prothrombin time ratio decreased 13.08 10.85 22 686390 516 62802094
Nausea 12.98 10.85 8756 677656 845715 61956895
Dyslipidaemia 12.95 10.85 39 686373 7354 62795256
Pulmonary alveolar haemorrhage 12.91 10.85 19 686393 4649 62797961
Limb mass 12.89 10.85 69 686343 3163 62799447
Hyperammonaemia 12.87 10.85 23 686389 5209 62797401
Hepatitis acute 12.83 10.85 153 686259 8967 62793643
Laboratory test abnormal 12.82 10.85 209 686203 26703 62775907
Upper gastrointestinal haemorrhage 12.80 10.85 136 686276 18716 62783894
Multiple fractures 12.75 10.85 146 686266 8472 62794138
Tardive dyskinesia 12.74 10.85 48 686364 8454 62794156
Cardiogenic shock 12.73 10.85 128 686284 17804 62784806
Drug reaction with eosinophilia and systemic symptoms 12.64 10.85 274 686138 33562 62769048
Adenovirus infection 12.59 10.85 12 686400 3559 62799051
Peripheral sensory neuropathy 12.56 10.85 40 686372 7411 62795199
Creatinine urine decreased 12.48 10.85 13 686399 187 62802423
Nocardiosis 12.48 10.85 3 686409 1973 62800637
Hypertriglyceridaemia 12.47 10.85 31 686381 6228 62796382
Psychomotor skills impaired 12.44 10.85 5 686407 2363 62800247
Anoxia 12.39 10.85 14 686398 222 62802388
Paradoxical drug reaction 12.38 10.85 16 686396 4136 62798474
Vital capacity decreased 12.37 10.85 44 686368 1684 62800926
Toxic skin eruption 12.32 10.85 85 686327 12800 62789810
Ear swelling 12.31 10.85 40 686372 1461 62801149
Impaired work ability 12.30 10.85 125 686287 17350 62785260
Atrial flutter 12.28 10.85 59 686353 9713 62792897
Post-traumatic stress disorder 12.27 10.85 98 686314 5153 62797457
Premature rupture of membranes 12.24 10.85 22 686390 4971 62797639
Infusion site discolouration 12.23 10.85 28 686384 829 62801781
Renal papillary necrosis 12.21 10.85 15 686397 261 62802349
Kidney transplant rejection 12.19 10.85 17 686395 4254 62798356
Allergy to chemicals 12.17 10.85 65 686347 2977 62799633
Aspartate aminotransferase 12.17 10.85 19 686393 418 62802192
Pregnancy with contraceptive device 12.13 10.85 20 686392 4674 62797936
Haemorrhage intracranial 12.11 10.85 90 686322 13329 62789281
Cytomegalovirus infection reactivation 12.10 10.85 15 686397 3948 62798662
Liver transplant 12.09 10.85 53 686359 2238 62800372
Sinus node dysfunction 12.07 10.85 20 686392 4665 62797945
Hallucination, auditory 12.06 10.85 85 686327 12739 62789871
Post procedural pulmonary embolism 12.03 10.85 15 686397 265 62802345
Haematochezia 12.03 10.85 465 685947 53079 62749531
Osmolar gap 12.02 10.85 10 686402 106 62802504
Mean cell haemoglobin concentration increased 11.98 10.85 21 686391 510 62802100
Drug tolerance decreased 11.96 10.85 260 686152 17213 62785397
Cryopyrin associated periodic syndrome 11.96 10.85 17 686395 343 62802267
Product dispensing error 11.94 10.85 64 686348 10241 62792369
Facet joint syndrome 11.92 10.85 191 686221 11947 62790663
Stress fracture 11.90 10.85 45 686367 7918 62794692
Blindness 11.89 10.85 164 686248 21535 62781075
Haemarthrosis 11.89 10.85 10 686402 3151 62799459
Corneal reflex decreased 11.87 10.85 11 686401 136 62802474
Injection site extravasation 11.86 10.85 147 686265 8694 62793916
Accidental exposure to product by child 11.85 10.85 34 686378 1159 62801451
Flatulence 11.84 10.85 285 686127 34417 62768193
Sinus tachycardia 11.83 10.85 345 686067 23923 62778687
Band neutrophil percentage increased 11.82 10.85 14 686398 234 62802376
Dysmorphism 11.81 10.85 5 686407 2291 62800319
Pain in extremity 11.78 10.85 3298 683114 328188 62474422
Mastocytosis 11.72 10.85 22 686390 564 62802046
Acute graft versus host disease in skin 11.71 10.85 12 686400 3440 62799170
SARS-CoV-2 test positive 11.70 10.85 136 686276 7920 62794690
Hepatic cancer 11.70 10.85 19 686393 4468 62798142
Oropharyngeal spasm 11.70 10.85 15 686397 273 62802337
Altered state of consciousness 11.67 10.85 197 686215 25033 62777577
Thyroxine free increased 11.66 10.85 28 686384 856 62801754
Vasodilation procedure 11.65 10.85 6 686406 25 62802585
Device use issue 11.62 10.85 7 686405 2623 62799987
Administration site pruritus 11.62 10.85 16 686396 313 62802297
Myelocyte count increased 11.60 10.85 17 686395 353 62802257
Haematoma 11.59 10.85 287 686125 34533 62768077
COVID-19 pneumonia 11.58 10.85 217 686195 13992 62788618
Oesophagitis 11.56 10.85 105 686307 14903 62787707
Bladder cancer 11.54 10.85 27 686385 5539 62797071
Maculopathy 11.52 10.85 5 686407 2257 62800353
Renal cancer 11.52 10.85 27 686385 5535 62797075
Peritonitis bacterial 11.51 10.85 22 686390 4857 62797753
Gastritis 11.48 10.85 311 686101 36992 62765618
Stoma site cellulitis 11.47 10.85 7 686405 43 62802567
Mood swings 11.46 10.85 134 686278 18114 62784496
Eye haemorrhage 11.45 10.85 50 686362 8446 62794164
Breast cancer stage II 11.42 10.85 52 686360 8684 62793926
Bradyphrenia 11.40 10.85 38 686374 6942 62795668
Loss of personal independence in daily activities 11.39 10.85 901 685511 96389 62706221
Lymphopenia 11.34 10.85 135 686277 18192 62784418
Mycobacterium avium complex infection 11.33 10.85 10 686402 3078 62799532
Intestinal haemorrhage 11.30 10.85 15 686397 3832 62798778
Condition aggravated 11.29 10.85 4040 682372 398177 62404433
Glycosylated haemoglobin increased 11.26 10.85 83 686329 12315 62790295
Urosepsis 11.26 10.85 137 686275 18387 62784223
Blood pressure systolic decreased 11.25 10.85 126 686286 7271 62795339
Impaired quality of life 11.25 10.85 95 686317 13688 62788922
White coat hypertension 11.22 10.85 24 686388 678 62801932
Liver injury 11.20 10.85 779 685633 59741 62742869
Tri-iodothyronine free increased 11.17 10.85 13 686399 213 62802397
Breast cancer metastatic 11.14 10.85 80 686332 11938 62790672
Ejection fraction decreased 11.11 10.85 172 686240 22160 62780450
Injury associated with device 11.07 10.85 14 686398 3652 62798958
Gout 11.05 10.85 91 686321 13180 62789430
Device failure 11.04 10.85 31 686381 5980 62796630
Prothrombin level increased 10.99 10.85 14 686398 253 62802357
Asthma 10.98 10.85 1209 685203 126352 62676258
Erysipelas 10.97 10.85 46 686366 7859 62794751
Feeling cold 10.94 10.85 337 686075 23551 62779059
Blood thyroid stimulating hormone decreased 10.91 10.85 86 686326 4504 62798106
Coronary artery bypass 10.91 10.85 6 686406 2363 62800247
Metabolic disorder 10.90 10.85 35 686377 6468 62796142
Hepatic encephalopathy 10.88 10.85 177 686235 11105 62791505
Disseminated tuberculosis 10.87 10.85 9 686403 2858 62799752
Gallbladder injury 10.85 10.85 37 686375 1386 62801224

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
Toxicity to various agents 1960.19 10.94 4603 267086 195759 34489483
Completed suicide 1767.87 10.94 2918 268771 95250 34589992
Infusion related reaction 1243.40 10.94 1783 269906 51274 34633968
Drug abuse 519.95 10.94 1823 269866 97273 34587969
Blood pressure fluctuation 443.00 10.94 743 270946 24506 34660736
Exposure to toxic agent 438.92 10.94 302 271387 3373 34681869
Intentional product misuse 411.20 10.94 1018 270671 44593 34640649
Overdose 353.16 10.94 1523 270166 89536 34595706
Urticaria 281.85 10.94 1094 270595 61283 34623959
Intentional overdose 281.29 10.94 862 270827 42812 34642430
Drug ineffective 279.39 10.94 2245 269444 454506 34230736
Blood pressure increased 256.07 10.94 1356 270333 86746 34598496
Heart rate decreased 242.40 10.94 666 271023 31079 34654163
Flushing 216.35 10.94 648 271041 31772 34653470
Respiratory arrest 211.78 10.94 586 271103 27457 34657785
Acute hepatic failure 199.01 10.94 377 271312 13697 34671545
Chills 198.80 10.94 1192 270497 79851 34605391
Oxygen saturation decreased 173.48 10.94 853 270836 52965 34632277
Blood pressure systolic increased 160.97 10.94 467 271222 22485 34662757
Blood pressure diastolic abnormal 159.33 10.94 192 271497 4626 34680616
Myocardial infarction 144.48 10.94 471 271218 120614 34564628
Cardio-respiratory arrest 143.24 10.94 825 270864 54448 34630794
Drug resistance 137.70 10.94 19 271670 25908 34659334
Cytokine release syndrome 124.14 10.94 426 271263 22451 34662791
Cardiac failure 123.20 10.94 335 271354 90913 34594329
Accidental overdose 121.75 10.94 389 271300 19751 34665491
Cardiac failure congestive 121.43 10.94 294 271395 82976 34602266
Sinusitis 120.66 10.94 638 271051 40764 34644478
Heart rate increased 120.24 10.94 692 270997 45651 34639591
Intentional product use issue 116.22 10.94 830 270859 58986 34626256
Poisoning 114.45 10.94 277 271412 11949 34673293
Respiratory depression 114.35 10.94 331 271358 15914 34669328
Drug interaction 109.98 10.94 1174 270515 224772 34460470
Exposure via ingestion 107.11 10.94 107 271582 2074 34683168
Anion gap 105.30 10.94 72 271617 795 34684447
Blood pressure systolic abnormal 104.73 10.94 141 271548 3807 34681435
Hepatic cytolysis 100.72 10.94 294 271395 14202 34671040
Metabolic acidosis 99.78 10.94 631 271058 43049 34642193
Anaemia 99.32 10.94 1249 270440 232086 34453156
Analgesic drug level increased 92.10 10.94 66 271623 790 34684452
Anaphylactic reaction 88.18 10.94 489 271200 31812 34653430
Diarrhoea 86.83 10.94 2338 269351 387574 34297668
Blood pressure diastolic increased 84.28 10.94 145 271544 4880 34680362
Renal impairment 83.36 10.94 414 271275 94099 34591143
Throat irritation 82.68 10.94 224 271465 10361 34674881
Cardiac arrest 81.51 10.94 1122 270567 95037 34590205
Throat tightness 76.77 10.94 188 271501 8170 34677072
Product dose omission issue 76.53 10.94 580 271109 119131 34566111
Infusion site extravasation 76.36 10.94 128 271561 4216 34681026
Infusion site swelling 74.49 10.94 95 271594 2429 34682813
Unresponsive to stimuli 74.34 10.94 416 271273 27153 34658089
Heart rate irregular 73.56 10.94 280 271409 15527 34669715
Infusion site pain 72.45 10.94 117 271572 3734 34681508
Pruritus 72.18 10.94 1525 270164 140456 34544786
Suspected suicide 70.62 10.94 130 271559 4618 34680624
Erythema 68.88 10.94 1020 270669 87760 34597482
Coagulopathy 66.84 10.94 318 271371 19471 34665771
Body temperature increased 66.80 10.94 290 271399 17078 34668164
Body temperature decreased 66.63 10.94 238 271451 12796 34672446
Blood pressure diastolic decreased 66.62 10.94 188 271501 8906 34676336
Tachycardia 65.39 10.94 973 270716 83799 34601443
Infusion site erythema 63.09 10.94 83 271606 2190 34683052
Febrile neutropenia 62.92 10.94 1449 270240 135400 34549842
Interstitial lung disease 62.83 10.94 277 271412 65005 34620237
Therapeutic product effect incomplete 60.62 10.94 196 271493 50345 34634897
Pyroglutamic acidosis 60.50 10.94 39 271650 387 34684855
Inappropriate schedule of product administration 59.92 10.94 744 270945 61552 34623690
Medication error 57.55 10.94 368 271321 25197 34660045
Hepatotoxicity 56.47 10.94 322 271367 21163 34664079
Suicide attempt 56.39 10.94 507 271182 38609 34646633
Poor venous access 55.72 10.94 124 271565 5059 34680183
Wrong technique in product usage process 55.69 10.94 123 271566 35863 34649379
Foetal exposure during pregnancy 55.13 10.94 135 271554 37966 34647276
General physical health deterioration 55.05 10.94 685 271004 127584 34557658
Environmental exposure 54.95 10.94 32 271657 260 34684982
Malignant neoplasm progression 54.17 10.94 431 271258 87615 34597627
Acute kidney injury 53.93 10.94 1885 269804 303103 34382139
Coronary artery disease 52.10 10.94 196 271493 48109 34637133
Treatment failure 51.99 10.94 187 271502 46510 34638732
COVID-19 51.08 10.94 867 270822 76683 34608559
Myelosuppression 49.46 10.94 46 271643 19219 34666023
Bone marrow failure 48.62 10.94 96 271593 29157 34656085
Pancytopenia 48.38 10.94 489 271200 94668 34590574
Labelled drug-drug interaction medication error 48.30 10.94 28 271661 14911 34670331
Hypotension 47.88 10.94 2143 269546 219506 34465736
Prostate cancer 46.69 10.94 155 271534 39494 34645748
Cerebral haemorrhage 46.56 10.94 129 271560 34808 34650434
Bladder cancer 46.56 10.94 35 271654 16243 34668999
Pharyngeal paraesthesia 45.99 10.94 40 271649 645 34684597
Ear infection 44.97 10.94 178 271511 10053 34675189
Disease progression 44.20 10.94 583 271106 107494 34577748
Cerebrovascular accident 43.46 10.94 435 271254 84376 34600866
Respiratory rate increased 43.38 10.94 172 271517 9722 34675520
Renal cortical necrosis 42.94 10.94 25 271664 203 34685039
Body temperature fluctuation 41.90 10.94 58 271631 1609 34683633
Infusion site rash 41.60 10.94 34 271655 501 34684741
Injection site pain 41.58 10.94 159 271530 38846 34646396
Cerebral infarction 40.73 10.94 96 271593 27359 34657883
Hepatic necrosis 39.92 10.94 90 271599 3704 34681538
Poisoning deliberate 39.89 10.94 143 271546 7701 34677541
Infusion site pruritus 39.72 10.94 40 271649 783 34684459
Substance abuse 39.46 10.94 140 271549 7501 34677741
Drug hypersensitivity 38.95 10.94 859 270830 79670 34605572
Sopor 38.87 10.94 23 271666 12113 34673129
Accident 38.61 10.94 106 271583 4941 34680301
Diabetes mellitus 38.11 10.94 211 271478 46662 34638580
Hospitalisation 38.09 10.94 272 271417 56630 34628612
Osteonecrosis of jaw 37.92 10.94 50 271639 17839 34667403
Renal failure 37.52 10.94 752 270937 129805 34555437
Aplastic anaemia 37.18 10.94 162 271527 9554 34675688
Oesophageal carcinoma 37.01 10.94 13 271676 9291 34675951
Fall 36.92 10.94 1249 270440 201636 34483606
Therapeutic response shortened 36.82 10.94 134 271555 7270 34677972
Alanine aminotransferase increased 36.57 10.94 854 270835 79961 34605281
Mydriasis 36.01 10.94 131 271558 7106 34678136
Glycosylated haemoglobin increased 35.73 10.94 22 271667 11338 34673904
Infusion site bruising 35.46 10.94 36 271653 712 34684530
Haematotoxicity 35.18 10.94 10 271679 8184 34677058
Hypersensitivity 34.75 10.94 667 271022 60368 34624874
Atrial fibrillation 34.56 10.94 707 270982 121686 34563556
Therapy partial responder 34.08 10.94 16 271673 9600 34675642
Pemphigus 34.08 10.94 52 271637 1579 34683663
Tongue disorder 33.98 10.94 105 271584 5234 34680008
Lymphocyte percentage decreased 33.78 10.94 60 271629 2072 34683170
Neutrophil percentage increased 33.55 10.94 55 271634 1778 34683464
Aspartate aminotransferase increased 33.40 10.94 725 270964 67058 34618184
Asthenia 33.34 10.94 1562 270127 243689 34441553
Pathogen resistance 33.26 10.94 16 271673 9466 34675776
Neuropathy peripheral 32.63 10.94 453 271236 82810 34602432
Post transplant lymphoproliferative disorder 31.93 10.94 6 271683 6522 34678720
Acute myocardial infarction 31.64 10.94 266 271423 53453 34631789
Visual acuity reduced 31.39 10.94 48 271641 16101 34669141
Cardiac failure chronic 31.36 10.94 11 271678 7868 34677374
Nasopharyngitis 30.92 10.94 737 270952 69231 34616011
Progressive multifocal leukoencephalopathy 30.58 10.94 19 271670 9745 34675497
Memory impairment 30.50 10.94 204 271485 43114 34642128
Anion gap abnormal 30.47 10.94 19 271670 177 34685065
Immune reconstitution inflammatory syndrome 30.39 10.94 15 271674 8744 34676498
Multiple-drug resistance 29.90 10.94 3 271686 5236 34680006
Graft versus host disease 29.87 10.94 23 271666 10546 34674696
Oedema peripheral 29.28 10.94 708 270981 119104 34566138
Infusion site reaction 29.02 10.94 35 271654 844 34684398
Vomiting 28.86 10.94 2266 269423 245355 34439887
Psoriasis 28.74 10.94 180 271509 38632 34646610
Feeling hot 28.38 10.94 252 271437 19120 34666122
Depressed level of consciousness 28.20 10.94 479 271210 42362 34642880
Angina pectoris 27.27 10.94 138 271551 31225 34654017
Hereditary angioedema 27.17 10.94 37 271652 1010 34684232
Syncope 27.09 10.94 524 271165 90927 34594315
Incorrect drug administration rate 27.03 10.94 48 271641 1657 34683585
Myopathy 26.91 10.94 30 271659 11524 34673718
Pneumonia 26.89 10.94 2440 269249 360187 34325055
Headache 26.57 10.94 1855 269834 198780 34486462
Decreased appetite 26.49 10.94 1041 270648 165351 34519891
Lung neoplasm malignant 26.46 10.94 60 271629 17335 34667907
Depression 26.19 10.94 565 271124 96533 34588709
Victim of child abuse 25.96 10.94 34 271655 893 34684349
Pulmonary oedema 25.90 10.94 516 271173 47013 34638229
Agitation 25.78 10.94 606 271083 56793 34628449
Cytomegalovirus infection 25.67 10.94 110 271579 26025 34659217
Septic shock 25.65 10.94 398 271291 71436 34613806
Visual impairment 25.51 10.94 168 271521 35634 34649608
Abdominal pain 25.50 10.94 1534 270155 162084 34523158
Erectile dysfunction 25.46 10.94 79 271610 20558 34664684
Leukopenia 25.33 10.94 340 271349 62516 34622726
Methaemoglobinaemia 25.23 10.94 73 271616 3508 34681734
Systemic infection 25.05 10.94 5 271684 5207 34680035
Thrombocytopenia 24.98 10.94 977 270712 155270 34529972
Myocardial fibrosis 24.78 10.94 38 271651 1159 34684083
Back pain 24.61 10.94 1170 270519 120619 34564623
Gastrointestinal haemorrhage 24.40 10.94 513 271176 87964 34597278
Blood creatine phosphokinase increased 24.26 10.94 227 271462 44630 34640612
Enthesopathy 24.23 10.94 85 271604 4528 34680714
Urine abnormality 23.98 10.94 50 271639 1949 34683293
Serum sickness 23.96 10.94 50 271639 1950 34683292
Therapeutic product effect decreased 23.77 10.94 165 271524 34578 34650664
Enterocolitis infectious 23.46 10.94 45 271644 1650 34683592
Drug level below therapeutic 23.33 10.94 96 271593 5519 34679723
Epilepsy 23.31 10.94 87 271602 21408 34663834
Ejection fraction decreased 23.15 10.94 74 271615 19080 34666162
Therapy cessation 23.11 10.94 62 271627 16911 34668331
Hypertriglyceridaemia 23.10 10.94 19 271670 8429 34676813
Hepatocellular carcinoma 22.99 10.94 15 271674 7494 34677748
Coma 22.95 10.94 490 271199 45188 34640054
Hyperkalaemia 22.93 10.94 390 271299 68999 34616243
Diabetic ketoacidosis 22.26 10.94 69 271620 17963 34667279
Fixed eruption 22.15 10.94 44 271645 1656 34683586
Tenosynovitis 22.13 10.94 82 271607 4488 34680754
Prostatic specific antigen increased 22.04 10.94 51 271638 14629 34670613
Appendicolith 22.01 10.94 128 271561 8473 34676769
Blood pH decreased 21.97 10.94 53 271636 2281 34682961
Acute myeloid leukaemia 21.79 10.94 71 271618 18199 34667043
Vital functions abnormal 21.65 10.94 18 271671 272 34684970
Oxygen saturation abnormal 21.64 10.94 41 271648 1489 34683753
Liver injury 21.51 10.94 193 271496 14685 34670557
Cardiac failure acute 20.94 10.94 31 271658 10539 34674703
Acute lung injury 20.79 10.94 40 271649 1470 34683772
Dizziness 20.69 10.94 1441 270248 217080 34468162
Pallor 20.62 10.94 295 271394 25185 34660057
Polyneuropathy 20.60 10.94 54 271635 14842 34670400
Monocyte percentage increased 20.40 10.94 31 271658 938 34684304
Circulatory collapse 20.39 10.94 89 271600 20949 34664293
Drug specific antibody present 20.35 10.94 64 271625 3221 34682021
Thrombotic microangiopathy 20.27 10.94 32 271657 10598 34674644
Accidental death 20.22 10.94 53 271636 2403 34682839
Chest discomfort 20.17 10.94 561 271128 53969 34631273
Generalised bullous fixed drug eruption 20.12 10.94 11 271678 78 34685164
Head discomfort 20.05 10.94 74 271615 4042 34681200
Pyrexia 20.01 10.94 2915 268774 330098 34355144
Infusion site discomfort 19.78 10.94 15 271674 197 34685045
Aspergillus infection 19.69 10.94 41 271648 12213 34673029
Sleep disorder due to a general medical condition 19.59 10.94 8 271681 5213 34680029
Melaena 19.58 10.94 178 271511 35202 34650040
Migraine 19.57 10.94 215 271474 17263 34667979
Tooth infection 19.48 10.94 104 271585 6667 34678575
Chronic gastrointestinal bleeding 19.45 10.94 18 271671 316 34684926
Blood pressure decreased 19.34 10.94 531 271158 50984 34634258
Urine sodium decreased 19.30 10.94 14 271675 171 34685071
Cytopenia 19.26 10.94 44 271645 12679 34672563
Oropharyngeal pain 19.25 10.94 385 271304 35100 34650142
Osteonecrosis 19.08 10.94 56 271633 14834 34670408
Ductus arteriosus premature closure 19.07 10.94 16 271673 245 34684997
Infusion site nodule 18.96 10.94 12 271677 115 34685127
Sinus tachycardia 18.73 10.94 212 271477 17148 34668094
Pulse absent 18.69 10.94 92 271597 5711 34679531
Haematuria 18.69 10.94 275 271414 49791 34635451
Product substitution issue 18.68 10.94 31 271658 10064 34675178
Stevens-Johnson syndrome 18.51 10.94 224 271465 18415 34666827
Toxic epidermal necrolysis 18.48 10.94 253 271436 21393 34663849
Upper respiratory tract infection 18.37 10.94 360 271329 32699 34652543
Hepatitis C 18.36 10.94 30 271659 9800 34675442
SARS-CoV-2 test positive 18.36 10.94 93 271596 5840 34679402
Gynaecomastia 18.16 10.94 32 271657 10148 34675094
Tuberculosis 18.15 10.94 24 271665 8553 34676689
Parkinsonism 18.02 10.94 22 271667 8116 34677126
Disturbance in attention 17.86 10.94 123 271566 25822 34659420
Ischaemic stroke 17.81 10.94 77 271612 18173 34667069
Neutropenia 17.74 10.94 1017 270672 155761 34529481
Chronic graft versus host disease 17.58 10.94 6 271683 4367 34680875
Haemorrhage 17.53 10.94 287 271402 51083 34634159
Intraocular pressure increased 17.53 10.94 10 271679 5373 34679869
Full blood count abnormal 17.47 10.94 80 271609 18588 34666654
Rash 17.32 10.94 1981 269708 220771 34464471
Lip swelling 17.18 10.94 196 271493 15884 34669358
Pulmonary congestion 17.14 10.94 173 271516 13592 34671650
Dyspnoea exertional 17.11 10.94 235 271454 43044 34642198
Pulmonary arterial hypertension 16.96 10.94 26 271663 8713 34676529
Crohn's disease 16.86 10.94 58 271631 3059 34682183
Crystal urine present 16.82 10.94 20 271669 475 34684767
Graft versus host disease in gastrointestinal tract 16.75 10.94 4 271685 3679 34681563
Specific gravity urine decreased 16.70 10.94 10 271679 86 34685156
Granulomatosis with polyangiitis 16.69 10.94 32 271657 1173 34684069
Nocardiosis 16.63 10.94 5 271684 3946 34681296
Pemphigoid 16.61 10.94 26 271663 8640 34676602
Injection site bruising 16.59 10.94 26 271663 8637 34676605
Apparent death 16.49 10.94 4 271685 3640 34681602
Myelodysplastic syndrome 16.42 10.94 85 271604 19123 34666119
Infusion site urticaria 16.38 10.94 12 271677 149 34685093
Congenital hiatus hernia 16.37 10.94 26 271663 818 34684424
Acidosis 16.35 10.94 143 271546 10802 34674440
Posterior reversible encephalopathy syndrome 16.25 10.94 33 271656 9921 34675321
Swelling face 16.18 10.94 261 271428 22844 34662398
Cytomegalovirus chorioretinitis 16.13 10.94 4 271685 3585 34681657
Blood glucose increased 16.08 10.94 395 271294 66323 34618919
Somnolence 16.04 10.94 1035 270654 110081 34575161
Renal disorder 15.99 10.94 124 271565 25356 34659886
Gastric cancer 15.96 10.94 16 271673 6453 34678789
Hypoxia 15.91 10.94 550 271139 54545 34630697
Fluid retention 15.89 10.94 133 271556 26754 34658488
Hyperhidrosis 15.88 10.94 730 270959 74962 34610280
Illness 15.88 10.94 168 271521 13361 34671881
Adverse event 15.88 10.94 84 271605 18793 34666449
Inadequate analgesia 15.78 10.94 55 271634 2920 34682322
Insurance issue 15.77 10.94 43 271646 1996 34683246
Palmar-plantar erythrodysaesthesia syndrome 15.70 10.94 72 271617 16723 34668519
Myalgia 15.68 10.94 516 271173 83594 34601648
Renal papillary necrosis 15.67 10.94 12 271677 160 34685082
Premature baby 15.62 10.94 89 271600 19544 34665698
Fluid replacement 15.61 10.94 13 271676 197 34685045
Arthropod sting 15.60 10.94 20 271669 514 34684728
Lymphocyte count abnormal 15.60 10.94 31 271658 1167 34684075
BK virus infection 15.57 10.94 13 271676 5725 34679517
Pulmonary embolism 15.48 10.94 556 271133 89190 34596052
Bronchopulmonary aspergillosis 15.46 10.94 60 271629 14599 34670643
Hepatocellular injury 15.43 10.94 105 271584 22106 34663136
Device leakage 15.39 10.94 17 271672 6558 34678684
Cardiac disorder 15.37 10.94 239 271450 42887 34642355
Vanishing bile duct syndrome 15.30 10.94 28 271661 990 34684252
Drug screen positive 15.28 10.94 66 271623 3877 34681365
Deep vein thrombosis 15.26 10.94 388 271301 64860 34620382
Dysmorphism 15.23 10.94 3 271686 3153 34682089
Product use in unapproved indication 15.20 10.94 752 270937 116747 34568495
Syringe issue 15.17 10.94 13 271676 5651 34679591
Bezoar 15.14 10.94 30 271659 1127 34684115
Hepatic function abnormal 15.09 10.94 248 271441 44115 34641127
Anaphylactoid reaction 15.05 10.94 46 271643 2279 34682963
Mental status changes 14.99 10.94 395 271294 37688 34647554
Subdural haematoma 14.97 10.94 95 271594 20326 34664916
Nodal rhythm 14.93 10.94 34 271655 1409 34683833
Eosinophilia 14.92 10.94 131 271558 26091 34659151
Congestive cardiomyopathy 14.91 10.94 22 271667 7488 34677754
Product use issue 14.89 10.94 617 271072 62599 34622643
Low birth weight baby 14.88 10.94 24 271665 7881 34677361
Acid-base balance disorder mixed 14.84 10.94 8 271681 55 34685187
Second primary malignancy 14.79 10.94 24 271665 7862 34677380
Specific gravity urine increased 14.79 10.94 11 271678 140 34685102
Administration site pruritus 14.78 10.94 6 271683 19 34685223
Electrocardiogram QRS complex prolonged 14.65 10.94 76 271613 4818 34680424
Injection site haemorrhage 14.61 10.94 34 271655 9734 34675508
Consciousness fluctuating 14.60 10.94 30 271659 1157 34684085
Transplant rejection 14.55 10.94 37 271652 10274 34674968
Gait inability 14.49 10.94 98 271591 20660 34664582
Exposure via inhalation 14.48 10.94 7 271682 37 34685205
Ischaemic cardiomyopathy 14.44 10.94 17 271672 6372 34678870
Injection site extravasation 14.42 10.94 53 271636 2889 34682353
Accidental exposure to product by child 14.41 10.94 34 271655 1442 34683800
Self-medication 14.37 10.94 50 271639 2653 34682589
Feeling cold 14.37 10.94 136 271553 10503 34674739
Infusion site haemorrhage 14.32 10.94 27 271662 977 34684265
Therapy non-responder 14.27 10.94 216 271473 38930 34646312
Skin lesion 14.20 10.94 106 271583 21855 34663387
Dehydration 14.17 10.94 846 270843 129123 34556119
Drug ineffective for unapproved indication 14.15 10.94 117 271572 23598 34661644
Depressed mood 14.09 10.94 90 271599 19227 34666015
Renal cancer 14.08 10.94 24 271665 7711 34677531
Transplant failure 14.07 10.94 5 271684 3548 34681694
Rhabdomyolysis 13.96 10.94 413 271276 67750 34617492
Balance disorder 13.92 10.94 227 271462 40427 34644815
Kidney transplant rejection 13.89 10.94 23 271666 7474 34677768
Neoplasm progression 13.88 10.94 115 271574 23185 34662057
Pneumonia necrotising 13.86 10.94 23 271666 751 34684491
Appendicitis 13.86 10.94 176 271513 14631 34670611
Acute graft versus host disease in skin 13.85 10.94 12 271677 5189 34680053
Aminoaciduria 13.82 10.94 14 271675 276 34684966
Immunosuppressant drug level increased 13.80 10.94 16 271673 6039 34679203
Cerebral artery thrombosis 13.73 10.94 23 271666 757 34684485
Sulphaemoglobinaemia 13.72 10.94 6 271683 24 34685218
Chronic spontaneous urticaria 13.66 10.94 10 271679 124 34685118
Right ventricular failure 13.61 10.94 30 271659 8754 34676488
Immune effector cell-associated neurotoxicity syndrome 13.52 10.94 61 271628 3652 34681590
Hepatic cirrhosis 13.50 10.94 79 271610 17235 34668007
Angina unstable 13.41 10.94 46 271643 11607 34673635
Anti-erythrocyte antibody positive 13.24 10.94 7 271682 46 34685196
Hepatitis fulminant 13.19 10.94 66 271623 4124 34681118
Chronic kidney disease 13.17 10.94 233 271456 40977 34644265
Administration site erythema 13.15 10.94 8 271681 71 34685171
Chronic obstructive pulmonary disease 13.08 10.94 285 271404 48633 34636609
Pulmonary alveolar haemorrhage 13.05 10.94 24 271665 7488 34677754
Adenocarcinoma of colon 13.05 10.94 5 271684 3386 34681856
Sexual dysfunction 12.97 10.94 18 271671 6285 34678957
Brain scan abnormal 12.97 10.94 24 271665 856 34684386
Acute graft versus host disease 12.96 10.94 19 271670 6484 34678758
White blood cells urine positive 12.88 10.94 30 271659 1262 34683980
Fasting 12.83 10.94 6 271683 29 34685213
Alanine aminotransferase abnormal 12.80 10.94 71 271618 4617 34680625
Haemolysis 12.75 10.94 107 271582 7987 34677255
Epstein-Barr virus infection 12.70 10.94 25 271664 7603 34677639
Plasma cell myeloma 12.70 10.94 240 271449 41797 34643445
Osteoporosis 12.64 10.94 53 271636 12615 34672627
Platelet transfusion 12.63 10.94 33 271656 1493 34683749
Gait disturbance 12.60 10.94 537 271152 84603 34600639
Infusion site irritation 12.57 10.94 13 271676 263 34684979
Exposure to SARS-CoV-2 12.56 10.94 18 271671 516 34684726
Asthma 12.44 10.94 245 271444 42411 34642831
Iron deficiency anaemia 12.42 10.94 40 271649 10289 34674953
Shock haemorrhagic 12.28 10.94 46 271643 11308 34673934
Epidural lipomatosis 12.22 10.94 26 271663 1028 34684214
Gastroenteritis viral 12.20 10.94 96 271593 7028 34678214
Swollen tongue 12.18 10.94 170 271519 14435 34670807
Apathy 12.17 10.94 22 271667 6910 34678332
Ductus arteriosus stenosis foetal 12.17 10.94 11 271678 187 34685055
Cough 12.16 10.94 1339 270350 148801 34536441
Retinal haemorrhage 12.09 10.94 13 271676 5076 34680166
Croup infectious 12.05 10.94 15 271674 374 34684868
Proctalgia 12.04 10.94 81 271608 5642 34679600
Bilirubin urine present 11.93 10.94 10 271679 153 34685089
Bacterial test 11.87 10.94 10 271679 154 34685088
Anion gap increased 11.80 10.94 37 271652 1859 34683383
Lymphocyte count decreased 11.79 10.94 244 271445 22378 34662864
Ultrasound liver abnormal 11.75 10.94 9 271680 120 34685122
Rhinitis 11.75 10.94 87 271602 6251 34678991
Venoocclusive liver disease 11.70 10.94 28 271661 7938 34677304
Dependent personality disorder 11.65 10.94 8 271681 89 34685153
Rheumatoid arthritis 11.61 10.94 384 271305 37854 34647388
Ear infection viral 11.60 10.94 3 271686 0 34685242
Infusion related hypersensitivity reaction 11.57 10.94 9 271680 123 34685119
Mean cell haemoglobin concentration decreased 11.55 10.94 28 271661 1209 34684033
Partial seizures 11.49 10.94 12 271677 4748 34680494
Severe invasive streptococcal infection 11.40 10.94 6 271683 39 34685203
Bacterial test positive 11.40 10.94 51 271638 3042 34682200
Obstructive airways disorder 11.39 10.94 72 271617 15422 34669820
Blindness 11.35 10.94 69 271620 14917 34670325
Red cell distribution width increased 11.32 10.94 84 271605 6039 34679203
Administration site swelling 11.31 10.94 11 271678 206 34685036
Blood magnesium abnormal 11.27 10.94 11 271678 207 34685035
Status epilepticus 11.25 10.94 55 271634 12559 34672683
Red blood cell sedimentation rate 11.21 10.94 27 271662 1161 34684081
Pharyngeal swelling 11.20 10.94 41 271648 2231 34683011
Aplasia pure red cell 11.19 10.94 19 271670 6113 34679129
Mucosal erosion 11.18 10.94 22 271667 822 34684420
Brain oedema 11.17 10.94 160 271529 13661 34671581
Prescribed underdose 11.16 10.94 34 271655 8899 34676343
Post embolisation syndrome 11.16 10.94 7 271682 66 34685176
Prothrombin time prolonged 11.13 10.94 117 271572 9289 34675953
Coronary artery bypass 11.12 10.94 13 271676 4889 34680353
Rhinalgia 11.10 10.94 25 271664 1028 34684214
Anticholinergic syndrome 11.08 10.94 28 271661 1241 34684001
Antineutrophil cytoplasmic antibody positive 11.08 10.94 21 271668 763 34684479
Oral pruritus 11.05 10.94 13 271676 305 34684937
Thrombosis 11.02 10.94 303 271386 50155 34635087
Cytomegalovirus viraemia 11.00 10.94 26 271663 7404 34677838
Acute coronary syndrome 10.99 10.94 61 271628 13484 34671758
Accidental poisoning 10.96 10.94 21 271668 769 34684473
Protein urine 10.95 10.94 23 271666 901 34684341
Hyperlipidaemia 10.95 10.94 67 271622 14462 34670780
Child abuse 10.95 10.94 15 271674 412 34684830

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 4918.55 10.18 8744 778404 237023 78720217
Toxicity to various agents 4550.60 10.18 11659 775489 409881 78547359
Infusion related reaction 1874.36 10.18 5757 781391 224480 78732760
Exposure to toxic agent 1163.60 10.18 858 786290 8300 78948940
Blood pressure fluctuation 920.86 10.18 2043 785105 65102 78892138
Intentional product misuse 865.57 10.18 2477 784671 92688 78864552
Drug abuse 801.62 10.18 3457 783691 159234 78798006
Overdose 777.18 10.18 3739 783409 180467 78776773
Intentional overdose 756.56 10.18 2535 784613 103425 78853815
Urticaria 597.88 10.18 3492 783656 181709 78775531
Acute hepatic failure 561.37 10.18 1041 786107 29072 78928168
Flushing 479.33 10.18 1933 785215 86335 78870905
Blood pressure increased 447.88 10.18 3593 783555 207767 78749473
Respiratory arrest 425.88 10.18 1394 785754 56156 78901084
Anaemia 408.42 10.18 2644 784504 442371 78514869
Drug interaction 396.79 10.18 2436 784712 412747 78544493
Heart rate decreased 385.03 10.18 1544 785604 68772 78888468
Cardio-respiratory arrest 379.56 10.18 2091 785057 106419 78850821
Blood pressure systolic increased 351.00 10.18 1451 785697 65535 78891705
Throat irritation 339.83 10.18 1032 786116 39914 78917326
Cardiac failure 327.45 10.18 645 786503 154197 78803043
Blood pressure diastolic abnormal 324.82 10.18 637 786511 18565 78938675
Oxygen saturation decreased 324.71 10.18 2285 784863 126762 78830478
Rheumatoid arthritis 312.14 10.18 3289 783859 205181 78752059
Acute kidney injury 308.51 10.18 3459 783689 515945 78441295
Pruritus 296.31 10.18 5506 781642 389142 78568098
Cardiac failure congestive 296.11 10.18 599 786549 141803 78815437
Intentional product use issue 295.90 10.18 2537 784611 149575 78807665
Anion gap 283.06 10.18 207 786941 1974 78955266
Analgesic drug level increased 279.75 10.18 240 786908 2938 78954302
Heart rate increased 272.45 10.18 2083 785065 118641 78838599
Product dose omission issue 263.30 10.18 1402 785746 246135 78711105
Blood pressure systolic abnormal 258.31 10.18 544 786604 16703 78940537
Myocardial infarction 257.56 10.18 941 786207 183188 78774052
Sinusitis 255.46 10.18 3003 784145 192498 78764742
Metabolic acidosis 253.09 10.18 1536 785612 80993 78876247
Exposure via ingestion 247.54 10.18 280 786868 4894 78952346
Hepatic cytolysis 245.97 10.18 706 786442 26445 78930795
Renal impairment 244.75 10.18 771 786377 157012 78800228
Drug resistance 244.39 10.18 58 787090 42155 78915085
Diarrhoea 241.54 10.18 6734 780414 873755 78083485
Injection site pain 232.68 10.18 592 786556 129246 78827994
Drug ineffective 230.51 10.18 8543 778605 1072370 77884870
Poisoning 227.83 10.18 656 786492 24616 78932624
Pancytopenia 212.58 10.18 877 786271 164868 78792372
Hepatotoxicity 211.63 10.18 1036 786112 50316 78906924
Blood pressure diastolic decreased 199.83 10.18 705 786443 29511 78927729
Neutropenia 198.53 10.18 1848 785300 285862 78671378
Medication error 193.89 10.18 1251 785897 67391 78889849
Nasopharyngitis 193.35 10.18 3551 783597 250330 78706910
Muscle injury 191.12 10.18 967 786181 47594 78909646
Interstitial lung disease 189.93 10.18 529 786619 112071 78845169
Hypersensitivity 182.62 10.18 3618 783530 258621 78698619
Malignant neoplasm progression 176.59 10.18 716 786432 135274 78821966
Sopor 173.04 10.18 55 787093 32955 78924285
Body temperature increased 173.03 10.18 882 786266 43538 78913702
Urine abnormality 172.18 10.18 299 786849 7920 78949320
Folliculitis 169.31 10.18 1030 786118 54350 78902890
Duodenal ulcer perforation 169.15 10.18 1177 785971 65034 78892206
Irritable bowel syndrome 165.28 10.18 1117 786031 61124 78896116
Device expulsion 163.23 10.18 29 787119 25832 78931408
Throat tightness 161.78 10.18 624 786524 27283 78929957
Suicide attempt 161.59 10.18 1384 785764 81548 78875692
Disease progression 160.39 10.18 1112 786036 183250 78773990
Osteonecrosis of jaw 158.36 10.18 117 787031 43109 78914131
Accidental overdose 157.04 10.18 790 786358 38791 78918449
Helicobacter infection 156.80 10.18 1202 785946 68502 78888738
Wrong technique in product usage process 156.73 10.18 307 786841 73568 78883672
Hyperkalaemia 151.89 10.18 597 786551 113801 78843439
Renal failure 150.83 10.18 1263 785885 199705 78757535
Bone marrow failure 146.39 10.18 173 786975 50934 78906306
Thrombocytopenia 145.72 10.18 1796 785352 263463 78693777
Sleep disorder due to general medical condition, insomnia type 144.03 10.18 827 786321 42729 78914511
Pneumonia 144.00 10.18 5201 781947 655045 78302195
Respiratory depression 143.50 10.18 597 786551 27033 78930207
Suspected suicide 138.41 10.18 316 786832 10260 78946980
Urine leukocyte esterase positive 136.96 10.18 185 786963 3906 78953334
Synovitis 134.82 10.18 2164 784984 148570 78808670
Impaired healing 132.46 10.18 1386 785762 86269 78870971
Coagulopathy 131.99 10.18 703 786445 35303 78921937
Inappropriate schedule of product administration 131.60 10.18 1950 785198 131678 78825562
Heart rate irregular 130.17 10.18 653 786495 32026 78925214
Poor venous access 130.10 10.18 435 786713 17714 78939526
Blood pressure diastolic increased 127.73 10.18 374 786774 14168 78943072
Chills 125.68 10.18 2252 784896 157982 78799258
Infusion site pain 123.95 10.18 364 786784 13812 78943428
Weight increased 122.98 10.18 3597 783551 273789 78683451
Hepatic enzyme increased 122.90 10.18 2507 784641 180103 78777137
Pyroglutamic acidosis 119.41 10.18 93 787055 983 78956257
Septic shock 118.83 10.18 717 786431 122084 78835156
Atrial fibrillation 118.24 10.18 1315 785833 196571 78760669
Injection site erythema 117.79 10.18 387 786761 77810 78879430
Anaphylactic reaction 116.73 10.18 1303 785845 82440 78874800
Ill-defined disorder 115.79 10.18 1075 786073 64800 78892440
Psoriasis 114.83 10.18 474 786674 89113 78868127
Discomfort 114.80 10.18 1810 785338 123807 78833433
Depressed level of consciousness 114.14 10.18 1457 785691 95195 78862045
Hospitalisation 113.81 10.18 510 786638 93726 78863514
Cerebrovascular accident 112.88 10.18 984 786164 154308 78802932
Anti-cyclic citrullinated peptide antibody positive 112.88 10.18 1287 785861 81856 78875384
Lower respiratory tract infection 112.51 10.18 1847 785301 127373 78829867
Cytokine release syndrome 110.96 10.18 671 786477 35327 78921913
Hepatic necrosis 109.38 10.18 263 786885 8837 78948403
Myelosuppression 108.51 10.18 143 787005 40153 78917087
Infusion site extravasation 107.69 10.18 279 786869 9829 78947411
Blister 107.47 10.18 1717 785431 117759 78839481
Poisoning deliberate 105.08 10.18 416 786732 18412 78938828
Therapy cessation 104.56 10.18 130 787018 37432 78919808
Food allergy 104.45 10.18 288 786860 10536 78946704
Gastrointestinal haemorrhage 103.86 10.18 944 786204 146775 78810465
Hand deformity 103.69 10.18 1520 785628 102399 78854841
Oedema peripheral 103.07 10.18 1810 785338 250478 78706762
Labelled drug-drug interaction medication error 102.37 10.18 74 787074 27576 78929664
Coronary artery disease 102.12 10.18 319 786829 65155 78892085
Injection site bruising 101.96 10.18 154 786994 40848 78916392
Hyponatraemia 101.10 10.18 1195 785953 176653 78780587
Erythema 100.98 10.18 2903 784245 220387 78736853
Therapeutic product effect incomplete 100.97 10.18 902 786246 140743 78816497
General physical health deterioration 100.57 10.18 2013 785135 273225 78684015
Infusion site swelling 100.39 10.18 232 786916 7594 78949646
Pemphigus 99.92 10.18 1458 785690 98124 78859116
Leukopenia 99.70 10.18 706 786442 115807 78841433
Body temperature decreased 99.60 10.18 600 786548 31545 78925695
Cardiac arrest 98.37 10.18 2308 784840 169788 78787452
Tachycardia 97.64 10.18 2371 784777 175397 78781843
Cerebral haemorrhage 97.19 10.18 271 786877 57402 78899838
Arthropathy 96.90 10.18 2361 784787 174750 78782490
White blood cells urine positive 96.11 10.18 196 786952 5879 78951361
Neoplasm progression 95.39 10.18 232 786916 51450 78905790
Cerebral infarction 95.00 10.18 192 786956 45484 78911756
Syncope 94.75 10.18 1225 785923 178224 78779016
Infusion site erythema 94.57 10.18 255 786893 9205 78948035
Respiratory rate increased 93.47 10.18 442 786706 21158 78936082
Neuropathy peripheral 93.36 10.18 917 786231 140388 78816852
Anticholinergic syndrome 92.71 10.18 144 787004 3467 78953773
Cytomegalovirus infection 92.38 10.18 175 786973 42469 78914771
Crystal urine present 91.81 10.18 110 787038 2050 78955190
Pericarditis 91.50 10.18 1492 785656 102744 78854496
Hereditary angioedema 90.24 10.18 177 786971 5158 78952082
Fall 88.66 10.18 3922 783226 483707 78473533
Decreased appetite 88.50 10.18 2638 784510 339780 78617460
Haematotoxicity 88.50 10.18 22 787126 15497 78941743
Ear pruritus 87.90 10.18 151 786997 3964 78953276
Respiratory failure 87.58 10.18 1257 785891 179654 78777586
Diabetes mellitus 86.60 10.18 438 786710 77952 78879288
Posterior reversible encephalopathy syndrome 86.51 10.18 79 787069 26202 78931038
Sedation complication 84.08 10.18 342 786806 15327 78941913
Acute myocardial infarction 83.65 10.18 433 786715 76603 78880637
Prostate cancer 83.65 10.18 124 787024 33144 78924096
Therapeutic response shortened 83.35 10.18 344 786804 15519 78941721
Chest discomfort 83.12 10.18 1865 785283 136179 78821061
Pathogen resistance 82.44 10.18 20 787128 14322 78942918
Rash 81.43 10.18 6696 780452 571662 78385578
Lymphocyte percentage decreased 80.45 10.18 162 786986 4814 78952426
Dehydration 79.12 10.18 1855 785293 246332 78710908
Lymphocyte count decreased 78.28 10.18 762 786386 46527 78910713
Infusion site pruritus 77.53 10.18 143 787005 3975 78953265
Post transplant lymphoproliferative disorder 76.53 10.18 11 787137 11453 78945787
Neutrophil percentage increased 76.22 10.18 153 786995 4536 78952704
Glossodynia 75.98 10.18 1438 785710 101899 78855341
Urinary sediment present 74.96 10.18 108 787040 2427 78954813
Epilepsy 74.17 10.18 185 786963 40675 78916565
Product substitution issue 73.97 10.18 55 787093 20201 78937039
Visual acuity reduced 73.94 10.18 110 787038 29359 78927881
Diabetic ketoacidosis 73.94 10.18 140 787008 33982 78923258
Anion gap abnormal 73.69 10.18 57 787091 596 78956644
Pharyngeal paraesthesia 73.37 10.18 111 787037 2610 78954630
Dyspnoea exertional 72.84 10.18 531 786617 86542 78870698
Unresponsive to stimuli 72.78 10.18 857 786291 54931 78902309
Body temperature fluctuation 72.69 10.18 133 787015 3674 78953566
Bladder cancer 72.63 10.18 52 787096 19474 78937766
Wound 72.59 10.18 1578 785570 114601 78842639
Pain 72.52 10.18 7970 779178 695832 78261408
Liver injury 72.23 10.18 866 786282 55748 78901492
Acute lung injury 71.87 10.18 118 787030 2982 78954258
Product prescribing error 71.55 10.18 216 786932 44597 78912643
Temperature regulation disorder 71.26 10.18 170 786978 5683 78951557
Swelling 71.10 10.18 2713 784435 213998 78743242
Systemic infection 70.92 10.18 7 787141 9745 78947495
Sepsis 69.75 10.18 2075 785073 267353 78689887
Cardiac failure acute 69.64 10.18 51 787097 18878 78938362
Myelodysplastic syndrome 69.53 10.18 120 787028 30181 78927059
Oesophageal carcinoma 68.72 10.18 13 787135 11071 78946169
Feeling hot 68.62 10.18 896 786252 58838 78898402
Haematuria 68.11 10.18 399 786749 68437 78888803
Lactic acidosis 67.94 10.18 411 786737 69948 78887292
Full blood count abnormal 67.59 10.18 191 786957 40283 78916957
Immune reconstitution inflammatory syndrome 67.49 10.18 26 787122 13815 78943425
Pulmonary arterial hypertension 67.24 10.18 110 787038 28256 78928984
Acute myeloid leukaemia 65.80 10.18 128 787020 30757 78926483
Mydriasis 65.02 10.18 345 786803 17298 78939942
Therapy interrupted 64.96 10.18 132 787016 31209 78926031
Contraindicated product administered 64.66 10.18 2024 785124 155514 78801726
Arthralgia 64.30 10.18 6514 780634 565289 78391951
Creatinine renal clearance decreased 64.26 10.18 363 786785 18639 78938601
Pulmonary hypertension 63.74 10.18 251 786897 47829 78909411
Chronic kidney disease 63.06 10.18 388 786760 65766 78891474
Hypokalaemia 62.48 10.18 1022 786126 143018 78814222
Osteonecrosis 61.90 10.18 134 787014 30961 78926279
Asthenia 61.78 10.18 4284 782864 507405 78449835
Hypocalcaemia 61.59 10.18 268 786880 49656 78907584
Thrombotic microangiopathy 61.34 10.18 65 787083 20104 78937136
Cardiac failure chronic 61.19 10.18 17 787131 11118 78946122
Systemic lupus erythematosus 60.92 10.18 1597 785551 119552 78837688
Aspergillus infection 60.26 10.18 60 787088 19101 78938139
Graft versus host disease 59.96 10.18 37 787111 14989 78942251
Rhabdomyolysis 59.72 10.18 690 786458 102441 78854799
Melaena 59.68 10.18 354 786794 60536 78896704
Product storage error 59.33 10.18 44 787104 16182 78941058
Product use in unapproved indication 59.01 10.18 1952 785196 248407 78708833
Blood calcium decreased 58.31 10.18 524 786624 31295 78925945
Subdural haematoma 58.09 10.18 141 787007 31293 78925947
Polyneuropathy 57.86 10.18 93 787055 24058 78933182
Multiple-drug resistance 57.53 10.18 9 787139 8799 78948441
Haemorrhage 56.58 10.18 600 786548 90518 78866722
Palmar-plantar erythrodysaesthesia syndrome 56.34 10.18 155 786993 32979 78924261
Platelet count decreased 56.04 10.18 1477 785671 193187 78764053
Ischaemic stroke 55.58 10.18 156 786992 32975 78924265
Agranulocytosis 55.38 10.18 242 786906 44788 78912452
Red blood cells urine positive 54.95 10.18 139 787009 4824 78952416
Transplant rejection 54.38 10.18 67 787081 19370 78937870
Weight fluctuation 54.29 10.18 244 786904 11431 78945809
Product monitoring error 54.05 10.18 11 787137 8895 78948345
Right ventricular failure 53.96 10.18 93 787055 23404 78933836
Second primary malignancy 53.66 10.18 38 787110 14312 78942928
Bronchopulmonary aspergillosis 53.27 10.18 86 787062 22208 78935032
COVID-19 52.91 10.18 1979 785169 155695 78801545
Gastrointestinal disorder 52.52 10.18 1579 785569 120626 78836614
Hepatocellular injury 52.52 10.18 266 786882 47327 78909913
Epistaxis 52.49 10.18 779 786369 110736 78846504
Coma 52.12 10.18 1332 785816 99317 78857923
Red cell distribution width increased 52.09 10.18 292 786856 14950 78942290
Hypotension 52.04 10.18 5034 782114 435283 78521957
Substance abuse 51.99 10.18 224 786924 10302 78946938
Environmental exposure 51.82 10.18 38 787110 364 78956876
Pneumocystis jirovecii pneumonia 51.67 10.18 157 786991 32351 78924889
Hepatic function abnormal 51.44 10.18 467 786681 72640 78884600
Injury 50.79 10.18 1060 786088 76436 78880804
Joint swelling 50.30 10.18 3400 783748 285246 78671994
Hepatic cirrhosis 49.01 10.18 178 786970 34728 78922512
Ear pain 48.82 10.18 518 786630 32351 78924889
Infusion site bruising 48.80 10.18 97 787051 2855 78954385
Lung neoplasm malignant 48.77 10.18 128 787020 27664 78929576
Multiple organ dysfunction syndrome 48.63 10.18 864 786284 119382 78837858
Injection site haemorrhage 48.42 10.18 129 787019 27741 78929499
Endophthalmitis 48.40 10.18 4 787144 6424 78950816
Device malfunction 48.25 10.18 86 787062 21362 78935878
Breast cancer stage I 48.23 10.18 5 787143 6695 78950545
Tongue disorder 47.94 10.18 268 786880 13707 78943533
Alanine aminotransferase increased 47.90 10.18 2012 785136 160558 78796682
Hypertensive crisis 47.89 10.18 82 787066 20688 78936552
Transient ischaemic attack 47.69 10.18 314 786834 52381 78904859
Myopathy 47.58 10.18 81 787067 20482 78936758
Specific gravity urine decreased 46.30 10.18 50 787098 828 78956412
Urine ketone body present 46.08 10.18 106 787042 3459 78953781
Bursitis 46.03 10.18 549 786599 35295 78921945
Incorrect drug administration rate 45.88 10.18 114 787034 3912 78953328
Cholecystitis chronic 45.29 10.18 206 786942 9700 78947540
Therapeutic product effect decreased 44.50 10.18 2011 785137 161852 78795388
Blood urine present 44.44 10.18 361 786787 20936 78936304
Pyroglutamate increased 44.42 10.18 44 787104 655 78956585
Cytopenia 43.84 10.18 84 787064 20299 78936941
Drug hypersensitivity 43.43 10.18 3470 783678 295446 78661794
Injection site swelling 42.58 10.18 281 786867 46851 78910389
Colorectal cancer 42.57 10.18 16 787132 8631 78948609
Neurotoxicity 42.31 10.18 171 786977 32347 78924893
Device difficult to use 41.99 10.18 42 787106 13343 78943897
Drug dose omission by device 41.71 10.18 6 787142 6244 78950996
Cytomegalovirus viraemia 41.65 10.18 39 787109 12782 78944458
Urine analysis abnormal 41.29 10.18 150 786998 6370 78950870
Drug level below therapeutic 40.88 10.18 198 786950 9572 78947668
Postmortem blood drug level increased 40.79 10.18 45 787103 764 78956476
Electric shock 40.65 10.18 59 787089 1335 78955905
Sexual dysfunction 40.57 10.18 13 787135 7750 78949490
Ascites 40.53 10.18 514 786634 75048 78882192
Congestive cardiomyopathy 40.48 10.18 34 787114 11746 78945494
Pleural effusion 40.27 10.18 1108 786040 144154 78813086
Unintentional medical device removal 40.15 10.18 13 787135 7699 78949541
Oral pruritus 39.94 10.18 80 787068 2368 78954872
Chronic graft versus host disease 39.88 10.18 9 787139 6772 78950468
Injection site pruritus 39.78 10.18 249 786899 42034 78915206
Drug ineffective for unapproved indication 39.77 10.18 319 786829 50919 78906321
Oropharyngeal pain 39.73 10.18 1385 785763 107968 78849272
Transplant dysfunction 39.72 10.18 11 787137 7210 78950030
Ear infection 39.34 10.18 516 786632 33916 78923324
Gastric cancer 39.33 10.18 26 787122 10153 78947087
Accidental death 39.27 10.18 112 787036 4179 78953061
Acute graft versus host disease 39.24 10.18 26 787122 10141 78947099
Immunodeficiency 39.13 10.18 357 786791 21411 78935829
Renal disorder 39.07 10.18 249 786899 41856 78915384
Infusion site mass 38.79 10.18 62 787086 1531 78955709
Headache 38.62 10.18 7169 779979 646603 78310637
Abortion spontaneous 38.50 10.18 155 786993 29352 78927888
Rheumatic fever 38.45 10.18 441 786707 28084 78929156
Blood pH decreased 38.39 10.18 118 787030 4593 78952647
Mucosal inflammation 38.38 10.18 520 786628 75060 78882180
Hepatic cancer 37.92 10.18 29 787119 10500 78946740
Angina pectoris 37.92 10.18 327 786821 51405 78905835
Gait disturbance 37.80 10.18 1668 785480 205838 78751402
Inappropriate antidiuretic hormone secretion 37.73 10.18 133 787015 26180 78931060
Bacterial test 37.48 10.18 53 787095 1170 78956070
Mitral valve incompetence 37.30 10.18 150 786998 28415 78928825
Drug specific antibody present 37.14 10.18 147 787001 6505 78950735
Breast cancer female 37.07 10.18 35 787113 11426 78945814
Memory impairment 37.01 10.18 830 786318 110904 78846336
Peripheral swelling 36.77 10.18 3115 784033 266502 78690738
Hyperlipidaemia 36.67 10.18 133 787015 25960 78931280
Toxic skin eruption 36.64 10.18 106 787042 22187 78935053
Specific gravity urine increased 36.63 10.18 33 787115 433 78956807
Acute respiratory failure 36.59 10.18 393 786755 59148 78898092
Circulatory collapse 36.38 10.18 220 786928 37448 78919792
Febrile bone marrow aplasia 36.30 10.18 45 787103 12975 78944265
Hepatocellular carcinoma 36.29 10.18 22 787126 8999 78948241
Sleep disorder due to a general medical condition 36.10 10.18 53 787095 14224 78943016
Epstein-Barr virus infection 35.98 10.18 54 787094 14362 78942878
C-reactive protein abnormal 35.86 10.18 674 786474 47693 78909547
Visual impairment 35.68 10.18 667 786481 91464 78865776
Bacterial test positive 35.63 10.18 157 786991 7292 78949948
Status epilepticus 35.62 10.18 127 787021 24914 78932326
Full blood count decreased 35.55 10.18 140 787008 26679 78930561
Treatment noncompliance 35.00 10.18 338 786810 51930 78905310
Monocyte percentage increased 34.97 10.18 70 787078 2071 78955169
Immunosuppressant drug level increased 34.96 10.18 23 787125 9004 78948236
Serum sickness 34.83 10.18 97 787051 3569 78953671
Angina unstable 34.77 10.18 69 787079 16458 78940782
Iron deficiency anaemia 34.68 10.18 133 787015 25539 78931701
Injection site mass 34.63 10.18 94 787054 20090 78937150
Coeliac disease 34.61 10.18 211 786937 11140 78946100
Blood creatine phosphokinase increased 34.54 10.18 452 786696 65638 78891602
Nocardiosis 34.50 10.18 7 787141 5672 78951568
Renal cancer 34.36 10.18 42 787106 12184 78945056
Pharyngitis 34.35 10.18 355 786793 22020 78935220
Fibromyalgia 34.34 10.18 855 786293 63485 78893755
Glycosylated haemoglobin increased 34.34 10.18 88 787060 19172 78938068
Metastases to liver 34.31 10.18 153 786995 28161 78929079
Tenosynovitis 34.28 10.18 267 786881 15287 78941953
Hepatitis B reactivation 34.18 10.18 9 787139 6099 78951141
Disease recurrence 34.05 10.18 275 786873 43834 78913406
Rash erythematous 33.97 10.18 778 786370 56991 78900249
Blood glucose increased 33.96 10.18 869 786279 114106 78843134
Infusion site discomfort 33.79 10.18 54 787094 1333 78955907
Pulmonary alveolar haemorrhage 33.65 10.18 38 787110 11419 78945821
Coronary arterial stent insertion 33.64 10.18 9 787139 6035 78951205
Extrapyramidal disorder 33.62 10.18 113 787035 22566 78934674
Hypertriglyceridaemia 33.50 10.18 46 787102 12694 78944546
Surgery 33.44 10.18 188 786960 32578 78924662
Mobility decreased 33.30 10.18 1500 785648 120675 78836565
Acute graft versus host disease in skin 33.23 10.18 17 787131 7641 78949599
Infusion site rash 33.18 10.18 60 787088 1642 78955598
Eosinophilia 33.07 10.18 287 786861 45058 78912182
Drug screen positive 33.06 10.18 133 787015 5930 78951310
Enthesopathy 33.03 10.18 212 786936 11396 78945844
Pancreatic carcinoma 32.79 10.18 52 787096 13525 78943715
Disturbance in social behaviour 32.64 10.18 5 787143 4965 78952275
Unevaluable event 32.52 10.18 371 786777 55214 78902026
Electrocardiogram QRS complex prolonged 32.16 10.18 200 786948 10633 78946607
Anion gap increased 32.03 10.18 95 787053 3625 78953615
BK virus infection 32.02 10.18 24 787124 8780 78948460
Device use error 31.97 10.18 15 787133 7086 78950154
Aspartate aminotransferase increased 31.87 10.18 1674 785474 136967 78820273
Deafness transitory 31.81 10.18 44 787104 951 78956289
Chronic obstructive pulmonary disease 31.67 10.18 623 786525 84796 78872444
Hepatic failure 31.66 10.18 810 786338 60402 78896838
Electrolyte imbalance 31.62 10.18 177 786971 30704 78926536
Hypoglycaemia 31.59 10.18 762 786386 100832 78856408
Myalgia 31.44 10.18 1504 785644 184137 78773103
Plasma cell myeloma 31.35 10.18 355 786793 52904 78904336
Renal cortical necrosis 31.31 10.18 27 787121 333 78956907
Device leakage 30.82 10.18 37 787111 10819 78946421
Hypoglycaemic coma 30.79 10.18 5 787143 4755 78952485
Culture urine positive 30.64 10.18 105 787043 4330 78952910
Therapy partial responder 30.62 10.18 80 787068 17317 78939923
Incorrect dose administered by device 30.62 10.18 6 787142 4983 78952257
Systemic lupus erythematosus rash 30.60 10.18 61 787087 1799 78955441
Disturbance in attention 30.54 10.18 337 786811 50464 78906776
Left ventricular dysfunction 30.42 10.18 94 787054 19267 78937973
Shock haemorrhagic 30.39 10.18 99 787049 19961 78937279
Aplastic anaemia 30.36 10.18 290 786858 17615 78939625
Parkinsonism 30.16 10.18 75 787073 16509 78940731
Upper gastrointestinal haemorrhage 30.13 10.18 262 786886 41118 78916122
Dyspnoea 29.90 10.18 7762 779386 849263 78107977
Haematochezia 29.90 10.18 648 786500 86997 78870243
Hypomagnesaemia 29.89 10.18 307 786841 46604 78910636
Human herpesvirus 6 infection 29.88 10.18 8 787140 5362 78951878
Brain death 29.74 10.18 123 787025 5554 78951686
Cystitis haemorrhagic 29.68 10.18 28 787120 9144 78948096
Migraine 29.54 10.18 1099 786049 86394 78870846
Large intestine polyp 29.45 10.18 50 787098 12658 78944582
Hepatitis C 29.44 10.18 45 787103 11880 78945360
Anxiety 29.42 10.18 2842 784306 245670 78711570
Metastases to lung 29.38 10.18 87 787061 18076 78939164
Hypothyroidism 29.37 10.18 353 786795 52039 78905201
Long QT syndrome 29.35 10.18 11 787137 5944 78951296
Injection site warmth 29.31 10.18 64 787084 14743 78942497
Graft versus host disease in gastrointestinal tract 29.28 10.18 13 787135 6343 78950897
Heart rate abnormal 29.23 10.18 128 787020 5929 78951311
Gynaecomastia 29.17 10.18 20 787128 7661 78949579
Ketoacidosis 29.10 10.18 21 787127 7833 78949407
Loss of consciousness 28.96 10.18 1358 785790 166585 78790655
Macular oedema 28.90 10.18 9 787139 5465 78951775
Diffuse large B-cell lymphoma 28.90 10.18 47 787101 12102 78945138
Prostatic specific antigen increased 28.85 10.18 36 787112 10350 78946890
Neuroleptic malignant syndrome 28.74 10.18 157 786991 27402 78929838
Device dislocation 28.73 10.18 145 787003 25825 78931415
Obstructive airways disorder 28.70 10.18 187 786961 31272 78925968
Graft versus host disease in skin 28.65 10.18 12 787136 6061 78951179
Cognitive disorder 28.56 10.18 898 786250 69028 78888212
Suicidal ideation 28.53 10.18 556 786592 75784 78881456
Bone erosion 28.50 10.18 86 787062 17761 78939479
Blood loss anaemia 28.26 10.18 70 787078 15428 78941812
Hyperglycaemia 28.23 10.18 506 786642 69829 78887411
Anticipatory anxiety 28.14 10.18 46 787102 1158 78956082
Varicella zoster virus infection 27.98 10.18 5 787143 4436 78952804
Ischaemic cardiomyopathy 27.96 10.18 21 787127 7674 78949566
Device issue 27.96 10.18 155 786993 26953 78930287
Kidney transplant rejection 27.95 10.18 36 787112 10210 78947030
Metastases to lymph nodes 27.88 10.18 37 787111 10360 78946880
Altered state of consciousness 27.84 10.18 287 786861 43535 78913705
Pharyngeal swelling 27.80 10.18 150 786998 7569 78949671
Dizziness 27.58 10.18 4672 782476 521769 78435471
Venoocclusive liver disease 27.57 10.18 46 787102 11725 78945515
Skin toxicity 27.35 10.18 25 787123 8289 78948951
Haemoglobin urine present 27.24 10.18 40 787108 915 78956325
Sedation 27.21 10.18 688 786460 51207 78906033
Tooth infection 27.14 10.18 295 786853 18537 78938703
Drug use disorder 27.13 10.18 162 786986 8489 78948751
Somnolence 26.98 10.18 2724 784424 236257 78720983
Lipodystrophy acquired 26.97 10.18 5 787143 4320 78952920
Injection site reaction 26.72 10.18 380 786768 54405 78902835
Back pain 26.71 10.18 3411 783737 300769 78656471
Lymphoproliferative disorder 26.64 10.18 11 787137 5604 78951636
Accidental exposure to product by child 26.41 10.18 76 787072 2850 78954390
Cardiac disorder 26.41 10.18 473 786675 65284 78891956
Injection site rash 26.24 10.18 90 787058 17864 78939376
Hypomania 26.10 10.18 145 787003 7399 78949841
Contusion 25.98 10.18 1753 785395 147023 78810217
Swollen joint count increased 25.95 10.18 343 786805 22584 78934656
Death 25.93 10.18 6137 781011 560377 78396863
Subarachnoid haemorrhage 25.72 10.18 139 787009 24326 78932914
Stomatitis 25.59 10.18 1729 785419 145028 78812212
Metastases to bone 25.56 10.18 139 787009 24288 78932952
Sinus node dysfunction 25.52 10.18 23 787125 7678 78949562
Coronary artery bypass 25.50 10.18 14 787134 6048 78951192
Pulmonary tuberculosis 25.46 10.18 24 787124 7841 78949399
Depression 25.43 10.18 1819 785329 214971 78742269
Premature delivery 25.41 10.18 132 787016 23335 78933905
Aphasia 25.39 10.18 317 786831 46415 78910825
Hyperammonaemia 25.39 10.18 44 787104 11049 78946191
Erectile dysfunction 25.38 10.18 68 787080 14596 78942644
Brain oedema 25.37 10.18 370 786778 24893 78932347
Renal papillary necrosis 25.37 10.18 26 787122 404 78956836
Nitrite urine present 25.35 10.18 44 787104 1165 78956075
Spinal stenosis 25.29 10.18 76 787072 15715 78941525
Cardiomyopathy 25.26 10.18 173 786975 28601 78928639
Sinus tachycardia 25.22 10.18 508 786640 36400 78920840
Bundle branch block left 25.15 10.18 47 787101 11466 78945774
Diplopia 24.77 10.18 211 786937 33255 78923985
Infusion site urticaria 24.73 10.18 42 787106 1092 78956148
Acute coronary syndrome 24.53 10.18 116 787032 21017 78936223
Product use issue 24.46 10.18 2397 784751 207425 78749815
Haematoma 24.42 10.18 365 786783 51830 78905410
Squamous cell carcinoma of skin 24.34 10.18 65 787083 13968 78943272
Analgesic drug level above therapeutic 24.31 10.18 27 787121 462 78956778
Fixed eruption 24.08 10.18 74 787074 2880 78954360
Eosinophil percentage increased 24.04 10.18 49 787099 1469 78955771
Metastases to central nervous system 23.99 10.18 82 787066 16293 78940947
Forced expiratory volume decreased 23.97 10.18 25 787123 7789 78949451
Aplasia pure red cell 23.94 10.18 25 787123 7785 78949455
Actinic keratosis 23.94 10.18 15 787133 6027 78951213
Infusion site haemorrhage 23.91 10.18 86 787062 3634 78953606
Vascular stent thrombosis 23.76 10.18 4 787144 3706 78953534
Tuberculosis 23.73 10.18 74 787074 15124 78942116
Aggression 23.62 10.18 357 786791 50601 78906639
Leukoencephalopathy 23.62 10.18 26 787122 7903 78949337
Thrombosis 23.17 10.18 642 786506 83458 78873782
Pneumonia aspiration 23.16 10.18 494 786654 66473 78890767
JC virus infection 23.13 10.18 5 787143 3876 78953364
Gestational diabetes 23.09 10.18 17 787131 6276 78950964
Hypervolaemia 23.03 10.18 290 786858 42400 78914840
Abnormal dreams 22.86 10.18 49 787099 11363 78945877
Toxicologic test abnormal 22.86 10.18 45 787103 1315 78955925
Left ventricular failure 22.85 10.18 37 787111 9544 78947696
Concomitant disease aggravated 22.83 10.18 61 787087 13106 78944134
Personality change 22.68 10.18 41 787107 10129 78947111
Haematocrit decreased 22.63 10.18 778 786370 60534 78896706
Pneumatosis intestinalis 22.56 10.18 18 787130 6379 78950861
Cardiotoxicity 22.53 10.18 55 787093 12184 78945056
Product quality issue 22.50 10.18 220 786928 33720 78923520
Pancreatitis acute 22.48 10.18 349 786799 49255 78907985
Dysarthria 22.48 10.18 502 786646 67120 78890120
Cytomegalovirus infection reactivation 22.39 10.18 32 787116 8684 78948556
Catheter site bruise 22.28 10.18 25 787123 433 78956807
Cardiovascular disorder 22.08 10.18 97 787051 17928 78939312
Diffuse large B-cell lymphoma recurrent 22.07 10.18 7 787141 4200 78953040
Partial seizures 22.05 10.18 34 787114 8944 78948296
Sudden infant death syndrome 22.04 10.18 20 787128 265 78956975
SARS-CoV-2 test positive 22.01 10.18 194 786954 11522 78945718
Generalised bullous fixed drug eruption 21.96 10.18 17 787131 178 78957062
Ageusia 21.93 10.18 87 787061 16545 78940695
Haemophagocytic lymphohistiocytosis 21.91 10.18 126 787022 21711 78935529
Bilirubin urine present 21.82 10.18 22 787126 335 78956905
Atypical femur fracture 21.81 10.18 12 787136 5177 78952063
Arrhythmia 21.78 10.18 450 786698 60822 78896418
Serum sickness-like reaction 21.69 10.18 29 787119 606 78956634
Carotid artery stenosis 21.67 10.18 33 787115 8725 78948515
Oedema 21.60 10.18 962 786186 118618 78838622
White blood cell count decreased 21.41 10.18 1584 785564 186704 78770536
Ejection fraction decreased 21.33 10.18 228 786920 34349 78922891
Compartment syndrome 21.27 10.18 103 787045 4979 78952261
Breast cancer 21.14 10.18 222 786926 33559 78923681
Night sweats 21.01 10.18 668 786480 51427 78905813
Anuria 21.01 10.18 121 787027 20842 78936398
Brain stem glioma 20.99 10.18 17 787131 191 78957049
Exposure via inhalation 20.94 10.18 14 787134 114 78957126
Klebsiella infection 20.87 10.18 82 787066 15638 78941602
Mucormycosis 20.87 10.18 32 787116 8437 78948803
Candida infection 20.84 10.18 259 786889 37955 78919285
Pain in jaw 20.82 10.18 325 786823 45826 78911414
Injection site extravasation 20.77 10.18 165 786983 9504 78947736
Tricuspid valve incompetence 20.72 10.18 112 787036 19600 78937640
Injection site induration 20.65 10.18 41 787107 9778 78947462
Gastritis erosive 20.56 10.18 48 787100 10799 78946441
Peripheral arterial occlusive disease 20.55 10.18 31 787117 8227 78949013
Blood creatinine decreased 20.50 10.18 140 787008 7685 78949555
Vein rupture 20.47 10.18 55 787093 1981 78955259
Victim of child abuse 20.39 10.18 35 787113 918 78956322
Mast cell activation syndrome 20.31 10.18 30 787118 690 78956550
No adverse event 20.31 10.18 252 786896 36940 78920300
Adenocarcinoma of colon 20.29 10.18 15 787133 5526 78951714
Akinesia 20.29 10.18 4 787144 3308 78953932
Pemphigoid 20.26 10.18 80 787068 15235 78942005
Pulmonary embolism 20.17 10.18 1440 785708 170214 78787026
Physical disability 20.17 10.18 4 787144 3294 78953946
Cerebral ischaemia 20.07 10.18 51 787097 11144 78946096
Muscle spasms 20.02 10.18 1469 785679 173261 78783979
Complications of transplanted kidney 19.94 10.18 20 787128 6346 78950894
Haemorrhage intracranial 19.90 10.18 164 786984 26029 78931211
Squamous cell carcinoma 19.79 10.18 83 787065 15539 78941701
Infective pulmonary exacerbation of cystic fibrosis 19.76 10.18 63 787085 12788 78944452
Disorientation 19.75 10.18 470 786678 62306 78894934
Nocturia 19.71 10.18 69 787079 13612 78943628
Diastolic dysfunction 19.58 10.18 49 787099 10762 78946478
Syringe issue 19.49 10.18 20 787128 6278 78950962
Tachyarrhythmia 19.47 10.18 24 787124 6938 78950302
Cytomegalovirus colitis 19.45 10.18 11 787137 4674 78952566
Cystitis 19.43 10.18 669 786479 52063 78905177
Retinal haemorrhage 19.35 10.18 32 787116 8185 78949055
Staphylococcal infection 19.31 10.18 433 786715 57862 78899378
Jaundice cholestatic 19.25 10.18 183 786965 11101 78946139
pH urine increased 19.18 10.18 23 787125 429 78956811
Adenovirus infection 18.88 10.18 34 787114 8413 78948827
Drug reaction with eosinophilia and systemic symptoms 18.85 10.18 486 786662 63758 78893482
Haemoptysis 18.81 10.18 415 786733 55584 78901656
Vital functions abnormal 18.81 10.18 31 787117 786 78956454
Seasonal allergy 18.80 10.18 246 786902 16160 78941080
Multiple drug therapy 18.79 10.18 85 787063 3993 78953247
Muscle spasticity 18.69 10.18 307 786841 21168 78936072
Stress 18.64 10.18 963 786185 78649 78878591
Blood pressure decreased 18.62 10.18 1179 785969 98287 78858953
Dyslipidaemia 18.62 10.18 56 787092 11577 78945663
Mean cell haemoglobin concentration decreased 18.59 10.18 92 787056 4487 78952753
Spinal compression fracture 18.58 10.18 95 787053 16863 78940377
Anal fissure 18.54 10.18 135 787013 7568 78949672
Multiple allergies 18.53 10.18 171 786977 10289 78946951
Haematemesis 18.53 10.18 384 786764 51880 78905360
Hip fracture 18.51 10.18 204 786944 30557 78926683
Acidosis 18.51 10.18 286 786862 19476 78937764
Diabetic metabolic decompensation 18.47 10.18 5 787143 3327 78953913
Peritonitis bacterial 18.41 10.18 42 787106 9525 78947715
Potentiating drug interaction 18.40 10.18 37 787111 8782 78948458
Prothrombin time prolonged 18.37 10.18 251 786897 16648 78940592
Dysstasia 18.33 10.18 180 786968 27566 78929674
Vision blurred 18.31 10.18 856 786292 105042 78852198
Bradyarrhythmia 18.30 10.18 9 787139 4137 78953103
Soft tissue disorder 18.29 10.18 76 787072 3439 78953801
Erysipelas 18.26 10.18 51 787097 10799 78946441
Hepatitis B 18.21 10.18 34 787114 8298 78948942
Fracture 18.20 10.18 133 787015 21668 78935572
Monoparesis 18.14 10.18 6 787142 3505 78953735
Osmolar gap 18.13 10.18 15 787133 174 78957066
Electrocardiogram QT prolonged 18.04 10.18 719 786429 89667 78867573
Cachexia 17.99 10.18 53 787095 11030 78946210
Bradyphrenia 17.92 10.18 50 787098 10590 78946650
Infusion site streaking 17.86 10.18 24 787124 504 78956736
Proteinuria 17.83 10.18 220 786928 32282 78924958
Nephropathy toxic 17.81 10.18 123 787025 20296 78936944
Transplant failure 17.74 10.18 12 787136 4629 78952611
Inhibitory drug interaction 17.72 10.18 11 787137 4442 78952798
Dyskinesia 17.68 10.18 323 786825 44450 78912790
Facet joint syndrome 17.67 10.18 180 786968 11122 78946118
Electric shock sensation 17.67 10.18 31 787117 828 78956412
Secondary immunodeficiency 17.65 10.18 5 787143 3229 78954011
White coat hypertension 17.64 10.18 31 787117 829 78956411
Eosinophilic granulomatosis with polyangiitis 17.64 10.18 7 787141 3653 78953587
Meningitis aseptic 17.59 10.18 123 787025 6805 78950435
Sputum culture positive 17.56 10.18 79 787069 3702 78953538
Hot flush 17.49 10.18 685 786463 54192 78903048
Cytomegalovirus chorioretinitis 17.48 10.18 17 787131 5473 78951767
Self-medication 17.33 10.18 98 787050 5034 78952206
Granulomatosis with polyangiitis 17.31 10.18 65 787083 2805 78954435
Lower gastrointestinal haemorrhage 17.29 10.18 91 787057 16034 78941206
Brain abscess 17.26 10.18 14 787134 4922 78952318
Agitation 17.24 10.18 1174 785974 98541 78858699
Feeling cold 17.23 10.18 388 786760 28341 78928899
Infusion site nodule 17.20 10.18 19 787129 323 78956917
Joint injury 17.20 10.18 418 786730 30917 78926323
Viral load increased 17.16 10.18 4 787144 2944 78954296
Oxygen saturation abnormal 17.16 10.18 90 787058 4492 78952748
Hemiparesis 17.15 10.18 232 786916 33501 78923739
Hallucination 17.13 10.18 682 786466 85063 78872177
Intestinal haemorrhage 17.10 10.18 23 787125 6403 78950837
Acute myeloid leukaemia recurrent 17.09 10.18 6 787142 3377 78953863
Leukaemia 17.03 10.18 20 787128 5905 78951335
Post-traumatic stress disorder 17.01 10.18 94 787054 4787 78952453
Band neutrophil count increased 17.00 10.18 27 787121 663 78956577
Gene mutation 16.98 10.18 3 787145 2683 78954557
Rheumatoid nodule 16.96 10.18 254 786894 17184 78940056
Blood creatinine increased 16.90 10.18 1309 785839 153748 78803492
Paradoxical drug reaction 16.90 10.18 28 787120 7157 78950083
Pericardial effusion 16.90 10.18 338 786810 45899 78911341
Pneumonia viral 16.87 10.18 151 786997 9007 78948233
Band neutrophil percentage increased 16.86 10.18 21 787127 408 78956832
Petit mal epilepsy 16.82 10.18 19 787129 5708 78951532
Administration site swelling 16.80 10.18 23 787125 492 78956748
B-cell lymphoma 16.79 10.18 22 787126 6193 78951047
Dyspnoea at rest 16.68 10.18 29 787119 7273 78949967
Coronary artery stenosis 16.65 10.18 65 787083 12419 78944821
Complication of device insertion 16.62 10.18 23 787125 6327 78950913
Urinary casts 16.60 10.18 37 787111 1182 78956058
Progressive multifocal leukoencephalopathy 16.57 10.18 127 787021 20473 78936767
Portal hypertension 16.44 10.18 28 787120 7080 78950160
Gastrooesophageal reflux disease 16.39 10.18 851 786297 103395 78853845
Diverticulum intestinal 16.38 10.18 38 787110 8567 78948673
Kidney infection 16.37 10.18 305 786843 21546 78935694
Haemolysis 16.35 10.18 196 786952 12616 78944624
Oropharyngeal discomfort 16.34 10.18 124 787024 7042 78950198
Uterine cancer 16.31 10.18 8 787140 3683 78953557
Infusion site scar 16.28 10.18 19 787129 344 78956896
Alanine aminotransferase abnormal 16.23 10.18 146 787002 8721 78948519
Embolic stroke 16.18 10.18 33 787115 7793 78949447
Periorbital swelling 16.17 10.18 64 787084 2832 78954408
Embolism venous 16.15 10.18 11 787137 4228 78953012
Mycobacterial infection 16.13 10.18 8 787140 3660 78953580
Coronary artery occlusion 16.11 10.18 87 787061 15228 78942012
Peritonitis 16.06 10.18 188 786960 27848 78929392
Atrioventricular block first degree 16.05 10.18 66 787082 12425 78944815
Peripheral sensory neuropathy 16.05 10.18 70 787078 12963 78944277
Blindness 16.00 10.18 191 786957 28192 78929048
Fungal rhinitis 15.95 10.18 10 787138 72 78957168
Deep vein thrombosis 15.95 10.18 1004 786144 119915 78837325
Cells in urine 15.93 10.18 15 787133 209 78957031
Vitamin K deficiency 15.93 10.18 27 787121 701 78956539
Euglycaemic diabetic ketoacidosis 15.80 10.18 27 787121 6817 78950423
Orthopnoea 15.76 10.18 49 787099 10024 78947216
Terminal state 15.73 10.18 15 787133 4874 78952366
Intraocular pressure increased 15.69 10.18 43 787105 9162 78948078
Product complaint 15.66 10.18 73 787075 13276 78943964
Dysgeusia 15.61 10.18 437 786711 56740 78900500
Skin lesion 15.56 10.18 305 786843 41539 78915701
Pleurothotonus 15.50 10.18 3 787145 2513 78954727
Pupil fixed 15.45 10.18 73 787075 3493 78953747
Thinking abnormal 15.42 10.18 72 787076 13089 78944151
Pericardial haemorrhage 15.41 10.18 13 787135 4482 78952758
Withdrawal syndrome 15.41 10.18 180 786968 26674 78930566
Anosognosia 15.39 10.18 9 787139 3755 78953485
Muscle haemorrhage 15.34 10.18 24 787124 6276 78950964
Infusion site warmth 15.33 10.18 40 787108 1415 78955825
COVID-19 immunisation 15.30 10.18 39 787109 1360 78955880
Jaundice 15.28 10.18 405 786743 52944 78904296
Antipsychotic drug level increased 15.17 10.18 22 787126 5935 78951305
Hyperthyroidism 15.13 10.18 143 787005 22066 78935174
Coagulation factor X level decreased 15.12 10.18 11 787137 104 78957136
Eye swelling 15.11 10.18 355 786793 26113 78931127
Limb mass 15.10 10.18 73 787075 3526 78953714
Epstein-Barr virus associated lymphoproliferative disorder 15.09 10.18 8 787140 3524 78953716
Toxoplasmosis 15.04 10.18 4 787144 2693 78954547
Cystic fibrosis pancreatic 15.03 10.18 9 787139 59 78957181
Atrioventricular block complete 15.02 10.18 99 787049 16511 78940729
Skin cancer 14.97 10.18 87 787061 14953 78942287
Allergy to chemicals 14.93 10.18 58 787090 2544 78954696
Sensitisation 14.90 10.18 7 787141 3304 78953936
Thyroid cancer 14.87 10.18 20 787128 5568 78951672
Red blood cell sedimentation rate 14.84 10.18 100 787048 5465 78951775
Prothrombin time ratio decreased 14.82 10.18 30 787118 895 78956345
Tardive dyskinesia 14.78 10.18 54 787094 10517 78946723
Acute graft versus host disease in intestine 14.72 10.18 11 787137 4030 78953210
Psychomotor skills impaired 14.71 10.18 18 787130 5219 78952021
Product dispensing error 14.70 10.18 74 787074 13189 78944051
Abortion induced 14.68 10.18 30 787118 7079 78950161
Perfume sensitivity 14.67 10.18 29 787119 850 78956390
Exposure to SARS-CoV-2 14.66 10.18 49 787099 1995 78955245
Concomitant disease progression 14.64 10.18 8 787140 3465 78953775
Ventricular tachycardia 14.60 10.18 309 786839 41626 78915614
Pharyngitis streptococcal 14.60 10.18 166 786982 10548 78946692
Neutrophil count decreased 14.59 10.18 768 786380 93191 78864049
Urobilinogen urine increased 14.51 10.18 25 787123 658 78956582
Nephrogenic systemic fibrosis 14.50 10.18 24 787124 6136 78951104
Vascular rupture 14.48 10.18 43 787105 1642 78955598
Left ventricular hypertrophy 14.46 10.18 59 787089 11132 78946108
Disseminated tuberculosis 14.46 10.18 12 787136 4171 78953069
Aortic valve incompetence 14.46 10.18 47 787101 9483 78947757
Emotional distress 14.45 10.18 506 786642 39463 78917777
Monocyte count increased 14.45 10.18 165 786983 10496 78946744
Underdose 14.43 10.18 235 786913 32916 78924324
Eyelid ptosis 14.42 10.18 58 787090 10986 78946254
Cerebral haematoma 14.38 10.18 36 787112 7906 78949334
Ear swelling 14.37 10.18 42 787106 1589 78955651
Chronic spontaneous urticaria 14.31 10.18 35 787113 1189 78956051
Injection site discomfort 14.25 10.18 18 787130 5148 78952092
Condition aggravated 14.25 10.18 4577 782571 496547 78460693
Adrenergic syndrome 14.25 10.18 12 787136 143 78957097
High density lipoprotein decreased 14.16 10.18 15 787133 4640 78952600
Cardiac dysfunction 14.05 10.18 12 787136 4112 78953128
Urine bilirubin decreased 14.05 10.18 12 787136 146 78957094
Pneumonia cytomegaloviral 14.04 10.18 17 787131 4952 78952288
Vein collapse 13.99 10.18 33 787115 1095 78956145
Accidental poisoning 13.97 10.18 42 787106 1615 78955625
Gastric haemorrhage 13.96 10.18 89 787059 14961 78942279
Consciousness fluctuating 13.94 10.18 47 787101 1922 78955318
Ventricular hypokinesia 13.91 10.18 46 787102 9233 78948007
Bradycardia 13.91 10.18 1150 785998 134407 78822833
Peripheral artery occlusion 13.87 10.18 4 787144 2553 78954687
Osteoarthritis 13.86 10.18 712 786436 86597 78870643
Vaginal haemorrhage 13.81 10.18 143 787005 21674 78935566
Paresis 13.80 10.18 13 787135 4248 78952992
Mycobacterium avium complex infection 13.79 10.18 15 787133 4585 78952655
Fluid retention 13.78 10.18 556 786592 69253 78887987
Intermenstrual bleeding 13.78 10.18 23 787125 5861 78951379
Tri-iodothyronine free increased 13.77 10.18 15 787133 251 78956989
Joint range of motion decreased 13.74 10.18 428 786720 32854 78924386
Rectal haemorrhage 13.74 10.18 614 786534 75686 78881554
Vertigo 13.68 10.18 550 786598 68532 78888708
Procedural anxiety 13.67 10.18 26 787122 740 78956500
End stage renal disease 13.65 10.18 68 787080 12152 78945088
Glucose tolerance impaired 13.61 10.18 38 787110 8046 78949194
Abdominal pain 13.56 10.18 4172 782976 385397 78571843
Drug-induced liver injury 13.55 10.18 790 786358 65327 78891913
Post cholecystectomy syndrome 13.54 10.18 18 787130 374 78956866
Focal dyscognitive seizures 13.53 10.18 9 787139 3503 78953737
Insurance issue 13.53 10.18 100 787048 5633 78951607
Lymphopenia 13.51 10.18 216 786932 30341 78926899
Deep vein thrombosis postoperative 13.50 10.18 164 786984 10588 78946652
Suspected COVID-19 13.47 10.18 64 787084 3069 78954171
Administration site bruise 13.42 10.18 13 787135 188 78957052
Lymphoma 13.41 10.18 109 787039 17351 78939889
Mucosal dryness 13.39 10.18 70 787078 3489 78953751
Inflammation 13.37 10.18 1087 786061 92666 78864574
Infusion related hypersensitivity reaction 13.36 10.18 18 787130 379 78956861
Dissociation 13.34 10.18 12 787136 4009 78953231
Enterococcal infection 13.33 10.18 95 787053 15565 78941675
Catheter management 13.31 10.18 10 787138 3653 78953587
Sulphaemoglobinaemia 13.30 10.18 8 787140 53 78957187
Cryopyrin associated periodic syndrome 13.29 10.18 18 787130 381 78956859
Psychotic symptom 13.26 10.18 5 787143 2692 78954548
Joint laxity 13.25 10.18 52 787096 2292 78954948
Granulocyte count increased 13.21 10.18 35 787113 1250 78955990
Carpal tunnel syndrome 13.19 10.18 126 787022 19402 78937838
Polyomavirus-associated nephropathy 13.17 10.18 22 787126 5605 78951635
Dry throat 13.16 10.18 125 787023 7581 78949659
Bezoar 13.12 10.18 57 787091 2631 78954609
Thyroxine free increased 13.12 10.18 34 787114 1198 78956042
Head injury 13.11 10.18 275 786873 37094 78920146
Mastocytosis 13.07 10.18 21 787127 521 78956719
Lipaemic index score 13.06 10.18 11 787137 131 78957109
Glutathione decreased 13.06 10.18 8 787140 55 78957185
Aortic valve stenosis 13.05 10.18 20 787128 5274 78951966
Atrioventricular block 13.04 10.18 83 787065 13958 78943282
Upper respiratory tract infection 12.99 10.18 1057 786091 90111 78867129
Mean cell haemoglobin concentration increased 12.96 10.18 28 787120 875 78956365
Therapeutic response unexpected 12.93 10.18 130 787018 19816 78937424
Fanconi syndrome 12.91 10.18 6 787142 2850 78954390
Lip dry 12.90 10.18 219 786929 15199 78942041
Leukocyturia 12.88 10.18 46 787102 1937 78955303
Wound infection 12.85 10.18 319 786829 23672 78933568
Intentional self-injury 12.76 10.18 234 786914 32185 78925055
Stenosis 12.76 10.18 4 787144 2418 78954822
Metabolic disorder 12.71 10.18 47 787101 9123 78948117
Hypoacusis 12.71 10.18 215 786933 29935 78927305
Femoral neck fracture 12.68 10.18 53 787095 9931 78947309
Ovarian hyperstimulation syndrome 12.65 10.18 10 787138 3561 78953679
Metastasis 12.60 10.18 31 787117 6849 78950391
Arteriosclerosis 12.57 10.18 117 787031 18110 78939130
Facial paresis 12.57 10.18 22 787126 5504 78951736
Cardiac tamponade 12.56 10.18 48 787100 9228 78948012
Vital capacity decreased 12.55 10.18 43 787105 1773 78955467
Hyperhidrosis 12.55 10.18 1693 785455 149799 78807441
Hemiplegia 12.54 10.18 91 787057 14848 78942392
White blood cells urine 12.54 10.18 20 787128 493 78956747
Precancerous cells present 12.53 10.18 33 787115 1174 78956066
Adjustment disorder with depressed mood 12.48 10.18 141 787007 8945 78948295
Red blood cells urine 12.48 10.18 24 787124 689 78956551
Delusion 12.46 10.18 135 787013 20288 78936952
Myocardial ischaemia 12.44 10.18 177 786971 25342 78931898
Generalised oedema 12.44 10.18 162 786986 23547 78933693
Intervertebral discitis 12.43 10.18 86 787062 4742 78952498
Colon cancer 12.41 10.18 88 787060 14435 78942805
Congenital hiatus hernia 12.35 10.18 26 787122 798 78956442
Cerebellar syndrome 12.30 10.18 22 787126 5458 78951782
Gallbladder injury 12.29 10.18 33 787115 1188 78956052
Hypocoagulable state 12.29 10.18 48 787100 2111 78955129
Dermatitis exfoliative 12.25 10.18 60 787088 10769 78946471
Nephrogenic diabetes insipidus 12.22 10.18 3 787145 2131 78955109
Thirst 12.21 10.18 121 787027 18498 78938742
Neutrophilia 12.21 10.18 39 787109 7912 78949328
Retinal deposits 12.11 10.18 11 787137 146 78957094
Paraesthesia ear 12.10 10.18 15 787133 290 78956950
Dystonia 12.06 10.18 144 787004 21255 78935985
Invasive ductal breast carcinoma 12.05 10.18 25 787123 5867 78951373
Methaemoglobinaemia 12.03 10.18 95 787053 5462 78951778
Metabolic syndrome 12.01 10.18 6 787142 2734 78954506
Akathisia 12.00 10.18 79 787069 13180 78944060
Faecaloma 11.99 10.18 66 787082 11498 78945742
Mechanical urticaria 11.97 10.18 18 787130 421 78956819
Febrile neutropenia 11.93 10.18 2517 784631 228482 78728758
Pre-eclampsia 11.92 10.18 33 787115 7008 78950232
Thoracic vertebral fracture 11.87 10.18 21 787127 5232 78952008
Asthma 11.83 10.18 1160 785988 133935 78823305
Necrotic lymphadenopathy 11.80 10.18 9 787139 92 78957148
Acute pulmonary oedema 11.79 10.18 87 787061 14143 78943097
Hyperglycaemic hyperosmolar nonketotic syndrome 11.78 10.18 4 787144 2299 78954941
Complication associated with device 11.77 10.18 113 787035 17383 78939857
Head discomfort 11.77 10.18 205 786943 14297 78942943
Varices oesophageal 11.77 10.18 26 787122 5965 78951275
Treatment failure 11.77 10.18 1488 785660 168998 78788242
Sensation of foreign body 11.74 10.18 94 787054 5428 78951812
Cutaneous T-cell lymphoma 11.73 10.18 6 787142 2697 78954543
Muscle atrophy 11.71 10.18 64 787084 11168 78946072
Blood triglycerides increased 11.70 10.18 142 787006 20898 78936342
Polycystic ovaries 11.69 10.18 12 787136 3767 78953473
Biliary dyskinesia 11.69 10.18 53 787095 2492 78954748
Stoma site cellulitis 11.68 10.18 7 787141 46 78957194
Eye haemorrhage 11.66 10.18 53 787095 9704 78947536
Atrial flutter 11.63 10.18 147 787001 21478 78935762
Bronchial disorder 11.61 10.18 5 787143 2484 78954756
Viral haemorrhagic cystitis 11.60 10.18 3 787145 2058 78955182
Pulmonary congestion 11.59 10.18 350 786798 26750 78930490
Nephropathy 11.57 10.18 53 787095 9685 78947555
Therapy change 11.57 10.18 36 787112 7363 78949877
Unmasking of previously unidentified disease 11.57 10.18 3 787145 2054 78955186
Pancreatitis 11.51 10.18 556 786592 68019 78889221
Acid-base balance disorder mixed 11.49 10.18 9 787139 96 78957144
Stent placement 11.46 10.18 30 787118 6490 78950750
Brain natriuretic peptide increased 11.45 10.18 47 787101 8853 78948387
Blood thyroid stimulating hormone decreased 11.45 10.18 96 787052 5620 78951620
Vaccination site pain 11.43 10.18 12 787136 192 78957048
Allergy to plants 11.43 10.18 24 787124 735 78956505
Low density lipoprotein increased 11.43 10.18 45 787103 8577 78948663
Ataxia 11.40 10.18 176 786972 24863 78932377
Seizure 11.39 10.18 1662 785486 187172 78770068
Sudden death 11.38 10.18 155 786993 22356 78934884
Device deployment issue 11.37 10.18 9 787139 3203 78954037
Cardiac operation 11.36 10.18 20 787128 4992 78952248
Eye infection 11.35 10.18 173 786975 11747 78945493
Hypogammaglobulinaemia 11.30 10.18 78 787070 12873 78944367
Neoplasm recurrence 11.30 10.18 15 787133 4199 78953041
Movement disorder 11.29 10.18 195 786953 27064 78930176
Anaemia macrocytic 11.24 10.18 24 787124 5573 78951667
Glomerular filtration rate decreased 11.23 10.18 157 786991 22545 78934695
Cellulitis 11.22 10.18 925 786223 108135 78849105
Vessel puncture site bruise 11.22 10.18 19 787129 493 78956747
Rash maculo-papular 11.21 10.18 446 786702 55632 78901608
Pneumonia necrotising 11.20 10.18 32 787116 1195 78956045
Ventricular fibrillation 11.19 10.18 235 786913 31691 78925549
Laboratory test abnormal 11.18 10.18 202 786946 27846 78929394
Hypovolaemic shock 11.18 10.18 73 787075 12203 78945037
Clostridium test positive 11.17 10.18 105 787043 6349 78950891
Oesophageal stenosis 11.17 10.18 16 787132 4338 78952902
PCO2 decreased 11.16 10.18 61 787087 3093 78954147
Catheterisation cardiac 11.14 10.18 25 787123 5703 78951537
Infusion site irritation 11.13 10.18 24 787124 749 78956491
Lung disorder 11.12 10.18 666 786482 79891 78877349
Lumbar vertebral fracture 11.10 10.18 34 787114 6988 78950252
Corneal oedema 11.10 10.18 6 787142 2614 78954626
Acute psychosis 11.08 10.18 15 787133 4165 78953075
Febrile infection 11.08 10.18 10 787138 3336 78953904
Osteolysis 11.08 10.18 17 787131 4481 78952759
Muscular weakness 11.07 10.18 1403 785745 159326 78797914
Smear cervix abnormal 11.05 10.18 52 787096 2484 78954756
Hepatitis E 11.04 10.18 8 787140 2978 78954262
Organising pneumonia 11.04 10.18 63 787085 10876 78946364
Vascular pseudoaneurysm 11.03 10.18 11 787137 3499 78953741
Tooth disorder 11.00 10.18 338 786810 25895 78931345
Blood potassium increased 11.00 10.18 213 786935 29062 78928178
Maternal exposure timing unspecified 10.93 10.18 96 787052 5696 78951544
Hyperammonaemic encephalopathy 10.91 10.18 19 787129 4763 78952477
Cryptococcosis 10.91 10.18 11 787137 3482 78953758
Focal segmental glomerulosclerosis 10.91 10.18 10 787138 3311 78953929
Tonsillolith 10.88 10.18 3 787145 0 78957240
Burn of internal organs 10.88 10.18 3 787145 0 78957240
Anti-erythrocyte antibody positive 10.88 10.18 8 787140 77 78957163
Impaired work ability 10.88 10.18 133 787015 19548 78937692
Breast cancer stage IV 10.79 10.18 3 787145 1961 78955279
Infection 10.79 10.18 2616 784532 239096 78718144
Lacunar infarction 10.79 10.18 27 787121 5930 78951310
Illness 10.76 10.18 562 786586 45949 78911291
Infusion site oedema 10.75 10.18 26 787122 877 78956363
Hypertension 10.73 10.18 3535 783613 327457 78629783
Paraplegia 10.71 10.18 21 787127 5032 78952208
Intestinal obstruction 10.70 10.18 333 786815 42687 78914553
Chronic gastrointestinal bleeding 10.68 10.18 18 787130 465 78956775
Cerebral toxoplasmosis 10.62 10.18 5 787143 2357 78954883
Secondary amyloidosis 10.60 10.18 12 787136 210 78957030
Musculoskeletal stiffness 10.59 10.18 1922 785226 173086 78784154
Bone lesion 10.59 10.18 27 787121 5892 78951348
Medication overuse headache 10.58 10.18 26 787122 886 78956354
Drug intolerance 10.58 10.18 2845 784303 261274 78695966
Injection site discolouration 10.57 10.18 39 787109 7575 78949665
Drug-disease interaction 10.56 10.18 29 787119 1058 78956182
Toothache 10.54 10.18 265 786883 19705 78937535
Anti-cyclic citrullinated peptide antibody 10.53 10.18 96 787052 5756 78951484
Urosepsis 10.51 10.18 191 786957 26304 78930936
Creatinine urine decreased 10.50 10.18 13 787135 251 78956989
Psychomotor retardation 10.46 10.18 29 787119 6155 78951085
Splenomegaly 10.46 10.18 143 787005 20611 78936629
Generalised tonic-clonic seizure 10.41 10.18 342 786806 43568 78913672
Urticaria thermal 10.40 10.18 17 787131 428 78956812
Ductus arteriosus stenosis foetal 10.39 10.18 8 787140 83 78957157
Chronic gastritis 10.39 10.18 15 787133 4053 78953187
Hypothermia 10.34 10.18 296 786852 22450 78934790
Delirium 10.32 10.18 970 786178 83657 78873583
Autoimmune haemolytic anaemia 10.32 10.18 45 787103 8335 78948905
Product adhesion issue 10.32 10.18 7 787141 2697 78954543
Enteritis 10.32 10.18 93 787055 14490 78942750
Accidental exposure to product 10.27 10.18 233 786915 31089 78926151
Nephrectomy 10.27 10.18 4 787144 2111 78955129
Mania 10.24 10.18 123 787025 18137 78939103
Paralysis 10.24 10.18 82 787066 13095 78944145
Ulcer 10.24 10.18 377 786771 29595 78927645
Diabetes mellitus inadequate control 10.24 10.18 173 786975 24091 78933149
Dermatitis allergic 10.22 10.18 122 787026 18008 78939232
Gastrointestinal perforation 10.22 10.18 29 787119 6108 78951132
Protein urine 10.21 10.18 36 787112 1506 78955734

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
Incorrect route of product administration 22.41 20.24 6 364 7 89415

Pharmacologic Action:

SourceCodeDescription
ATC D04AA32 DERMATOLOGICALS
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
Antihistamines for topical use
ATC R06AA02 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA52 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
FDA MoA N0000000190 Histamine H1 Receptor Antagonists
FDA EPC N0000175587 Histamine-1 Receptor Antagonist
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:36333 local anesthetics
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:48407 antiparkinson agent
CHEBI has role CHEBI:48876 muscarinic antagonists
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:51177 anti-tussive
CHEBI has role CHEBI:59683 antipruritic drugs
CHEBI has role CHEBI:66956 antidyskinetic agent
CHEBI has role CHEBI:146270 oneirogens
MeSH PA D000777 Anesthetics
MeSH PA D000779 Anesthetics, Local
MeSH PA D018926 Anti-Allergic Agents
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D006993 Hypnotics and Sedatives
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D000068776 Sleep Aids, Pharmaceutical

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

DiseaseRelationSNOMED_IDDOID
Vasomotor rhinitis indication 8229003 DOID:4730
Insomnia indication 193462001
Seasonal allergic rhinitis indication 367498001
Allergic conjunctivitis indication 473460002 DOID:11204
Migraine off-label use 37796009 DOID:6364
Anxiety disorder off-label use 197480006 DOID:2030
Local anesthesia off-label use 386761002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.52 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST Ki 7.81 WOMBAT-PK CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.59 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Kd 6.02 WOMBAT-PK
5-hydroxytryptamine receptor 2A GPCR Ki 6.43 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 6.15 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 6.29 DRUG MATRIX
Histamine H4 receptor GPCR Ki 4.37 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 7 WOMBAT-PK
Muscarinic acetylcholine receptor M2 GPCR Ki 6.92 WOMBAT-PK
Muscarinic acetylcholine receptor M3 GPCR Ki 6.64 WOMBAT-PK
Muscarinic acetylcholine receptor M4 GPCR Ki 6.95 WOMBAT-PK
Cytochrome P450 2D6 Enzyme Ki 4.93 WOMBAT-PK
Solute carrier family 22 member 2 Transporter IC50 4.68 WOMBAT-PK
Sodium channel alpha subunits; brain (Types I, II, III) Ion channel IC50 5.22 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 5.42 SCIENTIFIC LITERATURE
Muscarinic acetylcholine receptor M5 GPCR Ki 6.59 WOMBAT-PK
Sodium-dependent dopamine transporter Transporter Kd 5.66 SCIENTIFIC LITERATURE
Histamine H1 receptor GPCR IC50 9 CHEMBL

External reference:

IDSource
4019724 VUID
N0000147816 NUI
D00300 KEGG_DRUG
7491-10-3 SECONDARY_CAS_RN
103659-13-8 SECONDARY_CAS_RN
147-24-0 SECONDARY_CAS_RN
88637-37-0 SECONDARY_CAS_RN
1362 RXNORM
4017866 VANDF
4019724 VANDF
4020653 VANDF
C0012522 UMLSCUI
CHEBI:4636 CHEBI
2PM PDB_CHEM_ID
CHEMBL657 ChEMBL_ID
CHEMBL1201089 ChEMBL_ID
CHEMBL1620 ChEMBL_ID
DB01075 DRUGBANK_ID
D004155 MESH_DESCRIPTOR_UI
3100 PUBCHEM_CID
1224 IUPHAR_LIGAND_ID
1774 INN_ID
8GTS82S83M UNII
14992 MMSL
1676 MMSL
4611 MMSL
4612 MMSL
899 MMSL
d00212 MMSL
003369 NDDF
004787 NDDF
005115 NDDF
19510001 SNOMEDCT_US
26458009 SNOMEDCT_US
372682005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Childrens Dimetapp Multi-Symptom Cold and Flu HUMAN OTC DRUG LABEL 3 0031-2249 LIQUID 12.50 mg ORAL Unapproved drug other 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Severe Multi-Symptom Cough Cold Flu Nighttime HUMAN OTC DRUG LABEL 3 0031-8752 SOLUTION 25 mg ORAL OTC monograph final 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 25 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Honey Severe Cough, Flu Plus Sore Throat Nighttime HUMAN OTC DRUG LABEL 2 0031-8770 SOLUTION 25 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Direct Runny Nose HUMAN OTC DRUG LABEL 1 0031-9304 TABLET, COATED 25 mg ORAL OTC monograph final 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 16 sections
Excedrin PM Triple Action Caplets HUMAN OTC DRUG LABEL 3 0067-2056 TABLET, COATED 38 mg ORAL OTC monograph not final 16 sections
THERAFLUPOWERPODS NIGHTTIME SEVERE COLD HUMAN OTC DRUG LABEL 3 0067-6095 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 16 sections
Theraflu Severe Cold relief Nighttime HUMAN OTC DRUG LABEL 3 0067-6801 POWDER 25 mg ORAL OTC monograph final 17 sections
THERAFLUNIGHTTIME SEVERE COLD AND COUGH HUMAN OTC DRUG LABEL 3 0067-7918 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 17 sections
TRIAMINICNight Time Cold and Cough HUMAN OTC DRUG LABEL 2 0067-8106 SYRUP 6.25 mg ORAL OTC monograph final 15 sections
Theraflu Nighttime Multi-Symptom Severe Cold Powder HUMAN OTC DRUG LABEL 3 0067-8124 POWDER 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8129 SYRUP 25 mg ORAL OTC monograph final 16 sections
Theraflu ExpressMaxNighttime Severe Cold and Cough HUMAN OTC DRUG LABEL 3 0067-8137 TABLET, FILM COATED 12.50 mg ORAL OTC monograph final 16 sections
TherafluSevere Cold Relief Nighttime with Honey Elderberry Flavor HUMAN OTC DRUG LABEL 3 0067-8212 POWDER, FOR SOLUTION 25 mg ORAL OTC monograph final 17 sections
good sense ibuprofen pm HUMAN OTC DRUG LABEL 2 0113-0050 TABLET, FILM COATED 38 mg ORAL ANDA 16 sections
good sense sleep time HUMAN OTC DRUG LABEL 1 0113-0052 CAPSULE, LIQUID FILLED 25 mg ORAL OTC monograph final 16 sections
Good Sense Sleep Time HUMAN OTC DRUG LABEL 1 0113-0186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
Good Sense Sleep Time HUMAN OTC DRUG LABEL 1 0113-0186 SOLUTION 50 mg ORAL OTC monograph final 16 sections
good sense allergy HUMAN OTC DRUG LABEL 1 0113-0379 SOLUTION 12.50 mg ORAL OTC monograph final 14 sections
good sense nighttime sleep aid HUMAN OTC DRUG LABEL 1 0113-0431 TABLET, FILM COATED 25 mg ORAL OTC monograph final 16 sections
good sense pain relief pmextra strength HUMAN OTC DRUG LABEL 2 0113-0437 TABLET, FILM COATED 25 mg ORAL OTC monograph not final 16 sections
Good Sense Allergy Relief HUMAN OTC DRUG LABEL 1 0113-0462 CAPSULE 25 mg ORAL OTC monograph final 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0479 TABLET 25 mg ORAL OTC monograph final 15 sections
good sense allergy relief HUMAN OTC DRUG LABEL 1 0113-0479 TABLET 25 mg ORAL OTC monograph final 15 sections
good sense itch relief HUMAN OTC DRUG LABEL 2 0113-0622 CREAM 2 g TOPICAL OTC monograph not final 14 sections
Childrens Night Time Cold and Cough HUMAN OTC DRUG LABEL 2 0113-0808 SOLUTION 6.25 mg ORAL OTC monograph final 15 sections