pyridoxine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2836 65-23-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pyridoxine
  • adermin
  • bezatin
  • pirivitol
  • pyridoxin
  • pyridoxine hydrochloride
  • pyridoxine (vit B6)
  • vitamin b6
  • pyridoxine HCl
The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • Molecular weight: 169.18
  • Formula: C8H11NO3
  • CLOGP: -0.34
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 73.58
  • ALOGS: -1.02
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 222 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 39.43 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.66 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.90 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.98 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA HOSPIRA

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
Pemphigus 1533.66 10.02 3081 390707 117085 50094251
Systemic lupus erythematosus 1425.44 10.02 3284 390504 137338 50073998
Glossodynia 1230.80 10.02 2753 391035 112816 50098520
Rheumatoid arthritis 993.31 10.02 3646 390142 198904 50012432
Hand deformity 973.93 10.02 2303 391485 97896 50113440
Maternal exposure during pregnancy 893.27 10.02 3004 390784 156774 50054562
Arthropathy 877.62 10.02 2963 390825 154943 50056393
Alopecia 865.39 10.02 3986 389802 241061 49970275
Abdominal discomfort 862.83 10.02 3828 389960 227813 49983523
Wound 795.09 10.02 2207 391581 103587 50107749
Completed suicide 780.37 10.02 66 393722 131823 50079513
Infusion related reaction 622.97 10.02 2792 390996 166765 50044571
Synovitis 617.43 10.02 2243 391545 121622 50089714
Pericarditis 603.27 10.02 1654 392134 77035 50134301
Anti-cyclic citrullinated peptide antibody positive 593.00 10.02 1535 392253 69052 50142284
Discomfort 570.34 10.02 1998 391790 106382 50104954
Contraindicated product administered 569.14 10.02 2482 391306 146476 50064860
Toxicity to various agents 563.25 10.02 495 393293 212004 49999332
Swelling 542.71 10.02 3032 390756 197840 50013496
Joint swelling 520.15 10.02 3477 390311 241809 49969527
Pain 517.55 10.02 6814 386974 572089 49639247
Death 421.92 10.02 1222 392566 324157 49887179
Product use issue 370.48 10.02 2206 391582 147269 50064067
Rheumatoid factor positive 361.22 10.02 1027 392761 48832 50162504
Duodenal ulcer perforation 340.70 10.02 950 392838 44661 50166675
Arthralgia 335.97 10.02 5028 388760 433674 49777662
Drug abuse 335.22 10.02 37 393751 59809 50151527
Helicobacter infection 329.61 10.02 992 392796 48710 50162626
Drug interaction 323.49 10.02 667 393121 198954 50012382
Intentional overdose 318.36 10.02 52 393736 62452 50148884
Hepatic enzyme increased 300.61 10.02 1964 391824 135416 50075920
Exposure during pregnancy 285.75 10.02 1764 392024 119251 50092085
Hip arthroplasty 230.37 10.02 637 393151 29792 50181544
Musculoskeletal stiffness 224.62 10.02 1740 392048 126741 50084595
Drug intolerance 220.37 10.02 2640 391148 216464 49994872
Therapeutic product effect decreased 215.82 10.02 1802 391986 134248 50077088
Treatment failure 213.02 10.02 1813 391975 135824 50075512
Knee arthroplasty 212.28 10.02 688 393100 35158 50176178
Overdose 211.94 10.02 279 393509 99448 50111888
Febrile neutropenia 203.72 10.02 277 393511 97390 50113946
Cardiac arrest 196.90 10.02 216 393572 83435 50127901
Acute kidney injury 185.54 10.02 1029 392759 227029 49984307
Psoriatic arthropathy 182.54 10.02 788 393000 46244 50165092
Depressed level of consciousness 182.23 10.02 88 393700 51865 50159471
Nasopharyngitis 181.12 10.02 2295 391493 190632 50020704
Suicide attempt 179.36 10.02 89 393699 51643 50159693
Drug hypersensitivity 156.93 10.02 1226 392562 249784 49961552
Red blood cell sedimentation rate abnormal 156.68 10.02 374 393414 15969 50195367
Hypersensitivity 149.45 10.02 2428 391360 212733 49998603
Device expulsion 142.31 10.02 26 393762 28796 50182540
C-reactive protein abnormal 139.46 10.02 505 393283 27304 50184032
Malignant neoplasm progression 136.28 10.02 199 393589 67925 50143411
Diarrhoea 132.56 10.02 3528 390260 584948 49626388
Disease progression 132.08 10.02 349 393439 95517 50115819
Impaired healing 130.79 10.02 961 392827 68825 50142511
Rheumatic fever 130.54 10.02 356 393432 16511 50194825
Bradycardia 130.05 10.02 187 393601 64239 50147097
Nausea 129.72 10.02 4347 389441 701051 49510285
Lactic acidosis 128.92 10.02 49 393739 33306 50178030
Sedation 126.88 10.02 40 393748 30570 50180766
Swollen joint count increased 126.36 10.02 325 393463 14548 50196788
Sickle cell anaemia with crisis 126.12 10.02 166 393622 4377 50206959
Cardiac failure 121.37 10.02 256 393532 75784 50135552
Hyponatraemia 121.36 10.02 365 393423 95774 50115562
Constipation 117.87 10.02 903 392885 184805 50026531
Neutropenia 117.84 10.02 672 393116 147293 50064043
Drug ineffective 117.30 10.02 7626 386162 811707 49399629
Pregnancy 112.79 10.02 493 393295 29084 50182252
Hypotension 109.76 10.02 1237 392551 234232 49977104
Respiratory arrest 109.62 10.02 48 393740 29961 50181375
Anxiety 107.42 10.02 875 392913 176731 50034605
Fatigue 103.99 10.02 6602 387186 700999 49510337
Tremor 103.71 10.02 500 393288 114403 50096933
Somnolence 101.95 10.02 746 393042 154239 50057097
Psoriasis 101.46 10.02 899 392889 68101 50143235
Dizziness 100.70 10.02 1995 391793 344374 49866962
Agitation 100.00 10.02 163 393625 53221 50158115
Asthenia 98.43 10.02 1819 391969 317223 49894113
Renal failure 97.40 10.02 462 393326 106171 50105165
Sopor 95.87 10.02 19 393769 19860 50191476
Abortion spontaneous 94.76 10.02 603 393185 41169 50170167
Dyspnoea 93.62 10.02 3404 390384 544204 49667132
Live birth 91.82 10.02 309 393479 16099 50195237
Arthritis 91.43 10.02 1055 392733 85666 50125670
Vomiting 91.42 10.02 2810 390978 457948 49753388
Sleep disorder due to general medical condition, insomnia type 90.88 10.02 484 393304 30963 50180373
Rash 89.45 10.02 4210 389578 433261 49778075
Rhabdomyolysis 89.37 10.02 103 393685 38924 50172412
Muscle injury 89.37 10.02 544 393244 36567 50174769
Osteoarthritis 89.36 10.02 871 392917 67735 50143601
Folliculitis 87.60 10.02 564 393224 38661 50172675
Cardio-respiratory arrest 85.52 10.02 182 393606 53710 50157626
Multiple sclerosis relapse 85.43 10.02 126 393662 42838 50168498
Intentional self-injury 84.37 10.02 37 393751 23075 50188261
Electrocardiogram QT prolonged 84.20 10.02 173 393615 51713 50159623
Blister 82.08 10.02 1021 392767 84397 50126939
Lower respiratory tract infection 81.87 10.02 1115 392673 94086 50117250
Drug reaction with eosinophilia and systemic symptoms 80.36 10.02 62 393726 28362 50182974
Hyperhidrosis 79.02 10.02 392 393396 89034 50122302
Syncope 77.61 10.02 476 393312 102526 50108810
Injection site erythema 76.48 10.02 906 392882 74030 50137306
Drug dependence 76.40 10.02 29 393759 19730 50191606
Drug withdrawal syndrome 75.75 10.02 51 393737 25030 50186306
Hypoglycaemia 74.58 10.02 194 393594 53387 50157949
Product quality issue 74.45 10.02 78 393710 30780 50180556
Tachycardia 74.15 10.02 463 393325 99300 50112036
Neoplasm progression 72.28 10.02 72 393716 29085 50182251
Blood pressure fluctuation 70.37 10.02 499 393289 35324 50176012
Myalgia 69.95 10.02 624 393164 123695 50087641
Insomnia 69.60 10.02 950 392838 173915 50037421
Condition aggravated 67.87 10.02 2892 390896 294166 49917170
Joint effusion 67.44 10.02 239 393549 12782 50198554
Serotonin syndrome 67.24 10.02 56 393732 24657 50186679
Hypoxia 66 10.02 192 393596 50931 50160405
Injection site pruritus 64.89 10.02 537 393251 39874 50171462
Cognitive disorder 64.33 10.02 156 393632 43967 50167369
Irritable bowel syndrome 63.55 10.02 646 393142 50795 50160541
Asthma 63.13 10.02 421 393367 88916 50122420
Encephalopathy 63.07 10.02 103 393685 33608 50177728
No adverse event 62.44 10.02 103 393685 33475 50177861
Caesarean section 62.17 10.02 264 393524 15375 50195961
Metabolic acidosis 61.69 10.02 131 393657 38694 50172642
Intentional product misuse 61.44 10.02 174 393614 46560 50164776
Hyperglycaemia 61.11 10.02 119 393669 36286 50175050
Cardiac failure congestive 60.96 10.02 395 393393 83987 50127349
Disability assessment scale score increased 60.62 10.02 83 393705 2275 50209061
Juvenile idiopathic arthritis 60.37 10.02 92 393696 2787 50208549
Coma 60.16 10.02 233 393555 56646 50154690
Basal cell carcinoma 59.84 10.02 348 393440 23008 50188328
Urticaria 58.58 10.02 685 393103 128876 50082460
Renal impairment 58.38 10.02 347 393441 75314 50136022
Tuberculosis 58.30 10.02 192 393596 9891 50201445
Respiratory failure 56.55 10.02 446 393342 90735 50120601
Foot deformity 56.42 10.02 297 393491 18913 50192423
Multiple organ dysfunction syndrome 55.98 10.02 202 393586 50135 50161201
Feeling abnormal 54.62 10.02 669 393119 124823 50086513
Pulmonary embolism 54.38 10.02 517 393271 101187 50110149
Sinusitis 54.35 10.02 1724 392064 168834 50042502
Cholestasis 53.99 10.02 71 393717 25330 50186006
Joint laxity 53.67 10.02 79 393709 2319 50209017
Anaemia 53.55 10.02 1525 392263 250931 49960405
Red blood cell sedimentation rate increased 53.33 10.02 402 393386 29014 50182322
Muscle spasticity 53.17 10.02 34 393754 17150 50194186
Hepatic function abnormal 52.99 10.02 109 393679 32572 50178764
Drug resistance 52.95 10.02 42 393746 18947 50192389
Sedation complication 52.87 10.02 4 393784 8762 50202574
Balance disorder 52.75 10.02 327 393461 70263 50141073
Hepatic failure 52.07 10.02 108 393680 32175 50179161
Fluid retention 51.96 10.02 210 393578 50439 50160897
Thrombocytopenia 51.72 10.02 691 393097 126982 50084354
Blood glucose increased 51.45 10.02 334 393454 70990 50140346
Respiratory disorder 51.44 10.02 103 393685 31084 50180252
Cytomegalovirus infection 51.00 10.02 39 393749 17923 50193413
Hallucination 50.72 10.02 189 393599 46468 50164868
Hepatocellular injury 50.70 10.02 77 393711 25870 50185466
Contusion 50.54 10.02 1186 392602 110997 50100339
Emotional distress 50.48 10.02 91 393697 28572 50182764
Blood cholesterol increased 50.48 10.02 654 393134 54561 50156775
Peripheral swelling 50.42 10.02 2020 391768 203916 50007420
Anaphylactic reaction 50.04 10.02 233 393555 53822 50157514
Mydriasis 49.51 10.02 11 393777 10616 50200720
Blood pressure diastolic abnormal 49.50 10.02 173 393615 9188 50202148
Diabetic ketoacidosis 49.24 10.02 40 393748 17832 50193504
Premature labour 48.97 10.02 198 393590 11278 50200058
Ill-defined disorder 48.56 10.02 644 393144 54010 50157326
Foetal exposure during pregnancy 48.54 10.02 372 393416 26987 50184349
Injection site swelling 48.01 10.02 517 393271 41256 50170080
Altered state of consciousness 47.85 10.02 60 393728 21850 50189486
Osteoporosis 47.73 10.02 547 393241 44332 50167004
Mental status changes 47.71 10.02 135 393653 36137 50175199
Hyperkalaemia 47.70 10.02 202 393586 47887 50163449
Chest discomfort 47.61 10.02 476 393312 92246 50119090
Orthostatic hypotension 47.23 10.02 99 393689 29382 50181954
Injection site reaction 47.17 10.02 596 393192 49436 50161900
Dehydration 46.95 10.02 869 392919 151580 50059756
Disturbance in attention 46.46 10.02 109 393679 31077 50180259
Fibromyalgia 46.40 10.02 545 393243 44433 50166903
Loss of consciousness 45.90 10.02 555 393233 103798 50107538
Hypothermia 45.85 10.02 18 393770 11998 50199338
Shock 45.67 10.02 56 393732 20594 50190742
Depression 45.20 10.02 962 392826 164461 50046875
Metastases to bone 45.10 10.02 44 393744 17951 50193385
Pulmonary arterial hypertension 45.05 10.02 55 393733 20264 50191072
Type 2 diabetes mellitus 45.03 10.02 437 393351 33938 50177398
Injection site pain 44.99 10.02 1157 392631 109867 50101469
Muscle spasms 44.72 10.02 697 393091 124856 50086480
Delirium 44.66 10.02 150 393638 38042 50173294
Vision blurred 44.55 10.02 394 393394 78253 50133083
Suicidal ideation 44.33 10.02 251 393537 55134 50156202
Product administration error 44.01 10.02 53 393735 19646 50191690
Grip strength decreased 43.91 10.02 199 393589 11922 50199414
Poisoning 43.65 10.02 21 393767 12408 50198928
Restlessness 43.37 10.02 81 393707 25092 50186244
Bone erosion 43.18 10.02 193 393595 11494 50199842
Disorientation 43.13 10.02 137 393651 35347 50175989
Angioedema 42.68 10.02 150 393638 37526 50173810
Myocardial infarction 42.06 10.02 466 393322 88561 50122775
Speech disorder 41.99 10.02 139 393649 35409 50175927
Creatinine renal clearance decreased 41.84 10.02 20 393768 11861 50199475
Hospitalisation 41.33 10.02 334 393454 67603 50143733
Blood pressure systolic abnormal 41.25 10.02 143 393645 7563 50203773
Gestational diabetes 41.25 10.02 140 393648 7325 50204011
Neck deformity 41.18 10.02 63 393725 1915 50209421
Extrapyramidal disorder 41.16 10.02 20 393768 11750 50199586
Maternal drugs affecting foetus 41.13 10.02 109 393679 4968 50206368
Hypokalaemia 41.01 10.02 462 393326 87530 50123806
Blood pressure systolic increased 40.86 10.02 439 393349 35010 50176326
Osteonecrosis of jaw 40.65 10.02 124 393664 32402 50178934
Multiple fractures 40.13 10.02 128 393660 6483 50204853
Loss of personal independence in daily activities 40.11 10.02 767 393021 69283 50142053
Intentional product use issue 39.96 10.02 830 392958 76088 50135248
Cerebral haemorrhage 39.94 10.02 95 393693 26957 50184379
Seizure 39.77 10.02 661 393127 117213 50094123
Product use in unapproved indication 39.56 10.02 648 393140 115171 50096165
Decreased appetite 39.52 10.02 1226 392562 199697 50011639
Dyspnoea exertional 39.50 10.02 235 393553 50998 50160338
Disseminated intravascular coagulation 39.47 10.02 45 393743 17090 50194246
Maternal exposure before pregnancy 39.25 10.02 114 393674 5483 50205853
Blood pressure decreased 39.22 10.02 264 393524 55645 50155691
Posterior reversible encephalopathy syndrome 39.18 10.02 35 393753 14893 50196443
Ejection fraction decreased 39.12 10.02 52 393736 18468 50192868
Pain in jaw 39.00 10.02 160 393628 38268 50173068
Unresponsive to stimuli 38.75 10.02 116 393672 30493 50180843
Respiratory depression 38.22 10.02 23 393765 11987 50199349
Infection 37.90 10.02 1677 392111 171277 50040059
Pre-eclampsia 37.74 10.02 143 393645 7901 50203435
Neutrophil count decreased 37.70 10.02 207 393581 45819 50165517
Premature delivery 37.21 10.02 313 393475 23350 50187986
Torsade de pointes 37.19 10.02 23 393765 11812 50199524
Accidental overdose 37.18 10.02 59 393729 19474 50191862
Blood creatine phosphokinase increased 37.04 10.02 95 393693 26272 50185064
Leukopenia 36.63 10.02 342 393446 67186 50144150
Weight increased 36.53 10.02 1921 391867 199970 50011366
Metastases to liver 36.15 10.02 63 393725 20041 50191295
Rheumatoid nodule 36.10 10.02 195 393593 12540 50198796
Drug level increased 35.92 10.02 59 393729 19209 50192127
Gamma-glutamyltransferase increased 35.56 10.02 115 393673 29508 50181828
Blood alkaline phosphatase increased 35.18 10.02 161 393627 37365 50173971
Ventricular septal defect 35.04 10.02 89 393699 3952 50207384
Abnormal behaviour 34.99 10.02 62 393726 19596 50191740
Deep vein thrombosis 34.90 10.02 383 393405 72921 50138415
Nodule 34.65 10.02 239 393549 16764 50194572
Enthesopathy 33.86 10.02 128 393660 7065 50204271
Joint stiffness 33.85 10.02 373 393415 29935 50181401
Anaphylactic shock 33.72 10.02 66 393722 20089 50191247
Ascites 33.53 10.02 154 393634 35707 50175629
Blood bilirubin increased 33.39 10.02 132 393656 31906 50179430
Localised infection 33.38 10.02 324 393464 25161 50186175
Polyarthritis 33.22 10.02 136 393652 7791 50203545
Diabetes mellitus inadequate control 33.11 10.02 32 393756 13113 50198223
Chronic kidney disease 33.05 10.02 178 393610 39593 50171743
Flushing 32.76 10.02 348 393440 66667 50144669
Blood pressure diastolic decreased 32.51 10.02 233 393555 16548 50194788
Dysgeusia 32.43 10.02 174 393614 38742 50172594
Memory impairment 32.31 10.02 429 393359 78931 50132405
Limb deformity 32.13 10.02 82 393706 3652 50207684
Acute hepatic failure 32.12 10.02 45 393743 15632 50195704
Haemorrhage 31.93 10.02 264 393524 53177 50158159
Arrhythmia 31.74 10.02 141 393647 32991 50178345
Infective pulmonary exacerbation of cystic fibrosis 31.61 10.02 11 393777 7898 50203438
Latent tuberculosis 31.54 10.02 60 393728 2183 50209153
Palpitations 31.53 10.02 531 393257 93975 50117361
Wrong technique in product usage process 31.47 10.02 278 393510 55232 50156104
Femur fracture 31.45 10.02 437 393351 37027 50174309
Pulmonary oedema 31.44 10.02 237 393551 48701 50162635
Chest pain 31.06 10.02 1095 392693 175787 50035549
Injection site rash 30.99 10.02 224 393564 15953 50195383
Injection site bruising 30.91 10.02 429 393359 36339 50174997
Premature rupture of membranes 30.89 10.02 92 393696 4488 50206848
Ventricular tachycardia 30.86 10.02 47 393741 15774 50195562
Inappropriate antidiuretic hormone secretion 30.84 10.02 34 393754 13109 50198227
Device dislocation 30.76 10.02 77 393711 21469 50189867
Dysarthria 30.75 10.02 168 393620 37235 50174101
Pulmonary fibrosis 30.71 10.02 308 393480 24129 50187207
Joint destruction 30.64 10.02 83 393705 3833 50207503
Neuropathy peripheral 30.57 10.02 549 393239 96208 50115128
Tenderness 30.50 10.02 248 393540 18317 50193019
Drug ineffective for unapproved indication 30.42 10.02 76 393712 21205 50190131
Akathisia 30.31 10.02 13 393775 8216 50203120
International normalised ratio increased 30.15 10.02 204 393584 42948 50168388
Pleural effusion 30.08 10.02 449 393339 81005 50130331
Schizophrenia 30.06 10.02 10 393778 7387 50203949
Ventricular fibrillation 29.89 10.02 23 393765 10536 50200800
Coagulopathy 29.81 10.02 59 393729 17885 50193451
Musculoskeletal pain 29.76 10.02 754 393034 71423 50139913
Bone pain 29.74 10.02 230 393558 46999 50164337
Melaena 29.73 10.02 108 393680 26756 50184580
Palmar-plantar erythrodysaesthesia syndrome 29.34 10.02 71 393717 20027 50191309
Alanine aminotransferase increased 29.30 10.02 497 393291 87862 50123474
Nightmare 29.30 10.02 50 393738 16036 50195300
White blood cell count decreased 29.24 10.02 688 393100 116034 50095302
Vertigo 29.20 10.02 260 393528 51572 50159764
Small for dates baby 29.16 10.02 76 393712 3429 50207907
Atrial fibrillation 29.16 10.02 587 393201 101158 50110178
Withdrawal syndrome 29.08 10.02 58 393730 17532 50193804
Dysphagia 29.08 10.02 426 393362 77092 50134244
Pulmonary tuberculosis 28.98 10.02 86 393702 4187 50207149
Gastrointestinal haemorrhage 28.89 10.02 399 393389 72922 50138414
Aspartate aminotransferase increased 28.79 10.02 430 393358 77568 50133768
Blood calcium decreased 28.78 10.02 75 393713 20631 50190705
Device difficult to use 28.67 10.02 21 393767 9865 50201471
Oropharyngeal pain 28.42 10.02 800 392988 77001 50134335
Tenosynovitis stenosans 28.25 10.02 57 393731 2167 50209169
C-reactive protein increased 28.17 10.02 697 393091 65777 50145559
Disability 28.09 10.02 183 393605 12592 50198744
Pulmonary hypertension 28.08 10.02 149 393639 33268 50178068
Smear cervix abnormal 27.66 10.02 64 393724 2677 50208659
Heart rate decreased 27.58 10.02 418 393370 36079 50175257
Cerebrovascular accident 27.20 10.02 546 393242 94134 50117202
Ischaemic stroke 26.88 10.02 52 393736 15896 50195440
Stress cardiomyopathy 26.69 10.02 14 393774 7873 50203463
Accidental exposure to product 26.65 10.02 91 393697 22966 50188370
Respiratory distress 26.15 10.02 135 393653 30354 50180982
Irritability 26.03 10.02 123 393665 28303 50183033
Platelet count decreased 25.99 10.02 591 393197 100135 50111201
Laryngitis 25.99 10.02 160 393628 10796 50200540
Psychotic disorder 25.96 10.02 85 393703 21727 50189609
Synovial cyst 25.89 10.02 129 393659 8037 50203299
Neuroleptic malignant syndrome 25.88 10.02 29 393759 11101 50200235
Inflammation 25.71 10.02 602 393186 56310 50155026
Polyneuropathy 25.68 10.02 34 393754 12097 50199239
Eosinophilia 25.59 10.02 68 393720 18584 50192752
Joint range of motion decreased 25.56 10.02 238 393550 18274 50193062
Pain in extremity 25.53 10.02 2460 391328 270405 49940931
Cytokine release syndrome 25.48 10.02 18 393770 8616 50202720
Device use error 25.46 10.02 5 393783 5261 50206075
Toxic skin eruption 25.42 10.02 30 393758 11221 50200115
Bronchospasm 25.41 10.02 48 393740 14806 50196530
Haematotoxicity 25.29 10.02 15 393773 7880 50203456
Thrombotic microangiopathy 25.07 10.02 19 393769 8772 50202564
Macular degeneration 25.05 10.02 46 393742 14342 50196994
Acute respiratory failure 24.93 10.02 127 393661 28655 50182681
Brain oedema 24.86 10.02 36 393752 12334 50199002
Febrile bone marrow aplasia 24.84 10.02 9 393779 6302 50205034
Blood pressure diastolic increased 24.61 10.02 119 393669 7324 50204012
Dysmorphism 24.56 10.02 53 393735 2114 50209222
Arthritis infective 24.50 10.02 97 393691 5472 50205864
Oedema peripheral 24.37 10.02 993 392795 156968 50054368
Atrioventricular block complete 24.37 10.02 13 393775 7242 50204094
Tenosynovitis 24.25 10.02 153 393635 10412 50200924
Neck mass 24.09 10.02 69 393719 3292 50208044
Back pain 24.03 10.02 1434 392354 218596 49992740
Skin papilloma 23.98 10.02 80 393708 4149 50207187
Developmental hip dysplasia 23.95 10.02 39 393749 1252 50210084
Graft versus host disease 23.92 10.02 9 393779 6157 50205179
Obstructive airways disorder 23.88 10.02 54 393734 15598 50195738
Skin ulcer 23.86 10.02 397 393391 34921 50176415
Wheelchair user 23.84 10.02 89 393699 4883 50206453
Bradyphrenia 23.83 10.02 9 393779 6143 50205193
Second primary malignancy 23.80 10.02 12 393776 6902 50204434
Face oedema 23.75 10.02 66 393722 17773 50193563
Hypomagnesaemia 23.75 10.02 96 393692 23060 50188276
Cardiogenic shock 23.65 10.02 54 393734 15545 50195791
Hypervolaemia 23.54 10.02 110 393678 25389 50185947
Transplant rejection 23.50 10.02 24 393764 9585 50201751
Rotator cuff repair 23.03 10.02 45 393743 1671 50209665
Pancreatitis acute 23.01 10.02 101 393687 23711 50187625
Acute myeloid leukaemia 23.00 10.02 52 393736 15022 50196314
Asphyxia 22.65 10.02 7 393781 5420 50205916
Blood creatinine increased 22.54 10.02 437 393351 75723 50135613
Drug tolerance decreased 22.51 10.02 135 393653 9025 50202311
Malignant melanoma 22.35 10.02 145 393643 9963 50201373
Polyhydramnios 22.35 10.02 49 393739 1976 50209360
Placental disorder 22.31 10.02 40 393748 1390 50209946
Gastroenteritis viral 22.28 10.02 234 393554 18552 50192784
Confusional state 22.25 10.02 1201 392587 184727 50026609
Acute generalised exanthematous pustulosis 22.23 10.02 22 393766 8916 50202420
Sepsis 22.17 10.02 828 392960 132097 50079239
Synovial fluid analysis 22.03 10.02 43 393745 1595 50209741
Myoclonus 22.01 10.02 50 393738 14420 50196916
Paralysis 21.93 10.02 21 393767 8643 50202693
Agranulocytosis 21.85 10.02 89 393699 21332 50190004
Genital haemorrhage 21.76 10.02 12 393776 6562 50204774
Parkinsonism 21.75 10.02 22 393766 8825 50202511
Mania 21.71 10.02 32 393756 10884 50200452
Fear 21.55 10.02 51 393737 14498 50196838
Crying 21.35 10.02 84 393704 20332 50191004
Hemiparesis 21.27 10.02 82 393706 19966 50191370
Stevens-Johnson syndrome 21.18 10.02 92 393696 21660 50189676
Tachypnoea 20.88 10.02 52 393736 14525 50196811
Cardiac failure acute 20.88 10.02 20 393768 8230 50203106
Abdominal pain 20.85 10.02 1569 392219 234659 49976677
Acute graft versus host disease 20.81 10.02 3 393785 3955 50207381
Atrial septal defect 20.70 10.02 101 393687 6240 50205096
Spinal stenosis 20.66 10.02 178 393610 13372 50197964
Loose body in joint 20.52 10.02 35 393753 1168 50210168
Complication associated with device 20.43 10.02 53 393735 14602 50196734
Depressed mood 20.35 10.02 168 393620 33855 50177481
Haemorrhage intracranial 20.29 10.02 41 393747 12333 50199003
Hypermethioninaemia 20.15 10.02 7 393781 12 50211324
Aggression 20.15 10.02 90 393698 21026 50190310
Disease recurrence 20.13 10.02 84 393704 19997 50191339
Rash maculo-papular 20.11 10.02 123 393665 26518 50184818
Complication of device insertion 20.03 10.02 11 393777 6030 50205306
Neurotoxicity 20.03 10.02 54 393734 14686 50196650
Tumour lysis syndrome 19.96 10.02 17 393771 7404 50203932
Hallucination, auditory 19.86 10.02 33 393755 10695 50200641
Dyskinesia 19.82 10.02 131 393657 27730 50183606
Substance abuse 19.76 10.02 4 393784 4120 50207216
Blood potassium decreased 19.65 10.02 188 393600 36757 50174579
Postoperative wound infection 19.62 10.02 123 393665 8352 50202984
Labelled drug-drug interaction medication error 19.60 10.02 32 393756 10445 50200891
Cholecystitis chronic 19.57 10.02 28 393760 9641 50201695
Erythema multiforme 19.54 10.02 25 393763 9025 50202311
Body temperature decreased 19.34 10.02 204 393584 16191 50195145
Pemphigoid 19.24 10.02 11 393777 5896 50205440
Foetal death 19.11 10.02 119 393669 8061 50203275
Injection site warmth 19.01 10.02 178 393610 13688 50197648
Jaundice 18.93 10.02 124 393664 26305 50185031
Anhedonia 18.86 10.02 28 393760 9496 50201840
Stomatitis 18.85 10.02 967 392821 100377 50110959
Miosis 18.83 10.02 13 393775 6297 50205039
Metastases to central nervous system 18.83 10.02 37 393751 11245 50200091
Panic attack 18.72 10.02 82 393706 19260 50192076
Wheezing 18.67 10.02 355 393433 61692 50149644
Multiple allergies 18.66 10.02 23 393765 8440 50202896
Metastases to lung 18.51 10.02 36 393752 10984 50200352
Hypomania 18.47 10.02 6 393782 4499 50206837
Tubulointerstitial nephritis 18.29 10.02 59 393729 15152 50196184
Joint dislocation 18.27 10.02 161 393627 12172 50199164
Acute chest syndrome 18.23 10.02 24 393764 633 50210703
Ketoacidosis 18.21 10.02 4 393784 3891 50207445
Pancreatitis 18.21 10.02 228 393560 42386 50168950
Cytopenia 18.17 10.02 25 393763 8750 50202586
Uterine perforation 18.12 10.02 14 393774 6401 50204935
Haematoma 18.09 10.02 151 393637 30359 50180977
Body height below normal 18.03 10.02 44 393744 1905 50209431
Unevaluable event 18.03 10.02 251 393537 45815 50165521
Herpes zoster 17.90 10.02 697 393091 70089 50141247
Headache 17.88 10.02 3574 390214 502961 49708375
Synovial disorder 17.81 10.02 28 393760 872 50210464
Vitamin B6 increased 17.76 10.02 6 393782 9 50211327
Product adhesion issue 17.74 10.02 6 393782 4386 50206950
Foetal anticonvulsant syndrome 17.61 10.02 22 393766 550 50210786
Joint injury 17.42 10.02 252 393536 21537 50189799
Congenital arterial malformation 17.40 10.02 17 393771 320 50211016
Muscular weakness 17.40 10.02 585 393203 94428 50116908
Haemorrhage in pregnancy 17.35 10.02 40 393748 1669 50209667
Therapeutic response decreased 17.34 10.02 486 393302 46745 50164591
Nervousness 17.25 10.02 135 393653 27516 50183820
Oedema 17.20 10.02 415 393373 69766 50141570
Pyrexia 17.14 10.02 2647 391141 377556 49833780
Pulmonary congestion 17.07 10.02 61 393727 15186 50196150
Red blood cell sedimentation rate 17.03 10.02 64 393724 3522 50207814
COVID-19 16.95 10.02 258 393530 46404 50164932
Incorrect route of product administration 16.95 10.02 81 393707 18585 50192751
Infusion site erythema 16.95 10.02 26 393762 8701 50202635
Immune reconstitution inflammatory syndrome 16.95 10.02 11 393777 5505 50205831
Gestational hypertension 16.95 10.02 46 393742 2127 50209209
Infusion site pain 16.95 10.02 45 393743 12301 50199035
Tardive dyskinesia 16.89 10.02 19 393769 7260 50204076
Cyanosis 16.83 10.02 61 393727 15123 50196213
Stillbirth 16.78 10.02 91 393697 5861 50205475
Catheter site erythema 16.74 10.02 5 393783 3957 50207379
Aspergillus infection 16.72 10.02 17 393771 6804 50204532
Clear cell renal cell carcinoma 16.70 10.02 32 393756 1171 50210165
Maternal exposure timing unspecified 16.69 10.02 64 393724 3556 50207780
Temperature regulation disorder 16.69 10.02 6 393782 4221 50207115
Exposure to toxic agent 16.62 10.02 4 393784 3654 50207682
Pathogen resistance 16.61 10.02 12 393776 5677 50205659
Product dose omission issue 16.53 10.02 1219 392569 182619 50028717
Talipes 16.51 10.02 35 393753 1379 50209957
Haemophagocytic lymphohistiocytosis 16.50 10.02 26 393762 8607 50202729
Pericardial effusion 16.40 10.02 124 393664 25465 50185871
Cushingoid 16.37 10.02 98 393690 6547 50204789
Colitis microscopic 16.27 10.02 16 393772 6504 50204832
Breast feeding 16.25 10.02 26 393762 822 50210514
Lupus-like syndrome 16.25 10.02 128 393660 9363 50201973
Hallucination, visual 16.23 10.02 70 393718 16512 50194824
Joint noise 16.20 10.02 63 393725 3524 50207812
Dactylitis 16.15 10.02 41 393747 1820 50209516
Leukocytosis 16.14 10.02 106 393682 22473 50188863
Myocarditis 16.09 10.02 23 393765 7924 50203412
Mouth ulceration 16.08 10.02 307 393481 27717 50183619
Shock haemorrhagic 16.07 10.02 25 393763 8319 50203017
Abdominal distension 16.02 10.02 438 393350 72465 50138871
Aphasia 16.02 10.02 143 393645 28351 50182985
Generalised oedema 16.00 10.02 54 393734 13677 50197659
Psychomotor hyperactivity 15.96 10.02 30 393758 9271 50202065
Abortion missed 15.94 10.02 37 393751 1551 50209785
Crohn's disease 15.89 10.02 76 393712 4657 50206679
Haemoptysis 15.88 10.02 125 393663 25448 50185888
Acidosis 15.83 10.02 35 393753 10192 50201144
Hyperlipidaemia 15.82 10.02 76 393712 17414 50193922
Angina pectoris 15.81 10.02 129 393659 26059 50185277
Antinuclear antibody positive 15.77 10.02 93 393695 6179 50205157
Neonatal respiratory distress syndrome 15.76 10.02 51 393737 2603 50208733
Pharyngitis streptococcal 15.75 10.02 120 393668 8688 50202648
Skin cancer 15.71 10.02 126 393662 9268 50202068
Delusion 15.69 10.02 37 393751 10532 50200804
Malaise 15.68 10.02 2331 391457 333201 49878135
Proteinuria 15.68 10.02 71 393717 16526 50194810
Fear of injection 15.67 10.02 91 393697 6012 50205324
Scleritis 15.67 10.02 58 393730 3169 50208167
Fracture delayed union 15.62 10.02 46 393742 2230 50209106
Device related infection 15.51 10.02 96 393692 20639 50190697
Renal injury 15.47 10.02 27 393761 8584 50202752
Hypophosphataemia 15.46 10.02 26 393762 8388 50202948
Oliguria 15.46 10.02 25 393763 8191 50203145
Lethargy 15.44 10.02 281 393507 49151 50162185
Urinary retention 15.36 10.02 130 393658 26060 50185276
Poor venous access 15.33 10.02 135 393653 10205 50201131
Squamous cell carcinoma 15.31 10.02 108 393680 7631 50203705
Infusion site swelling 15.31 10.02 20 393768 7156 50204180
Diabetes mellitus 15.23 10.02 279 393509 48754 50162582
Fracture 15.22 10.02 199 393589 16634 50194702
Cardiomyopathy 15.13 10.02 66 393722 15520 50195816
Skin exfoliation 15.06 10.02 178 393610 33434 50177902
Polyuria 15.03 10.02 20 393768 7101 50204235
Exomphalos 15.03 10.02 20 393768 533 50210803
Blood iron increased 14.98 10.02 33 393755 1335 50210001
Atrioventricular block 14.93 10.02 17 393771 6461 50204875
Lip swelling 14.86 10.02 122 393666 24614 50186722
Induced labour 14.82 10.02 26 393762 888 50210448
Hypophagia 14.79 10.02 141 393647 27587 50183749
Oral herpes 14.75 10.02 235 393553 20490 50190846
Bradypnoea 14.69 10.02 3 393785 3071 50208265
Complication of device removal 14.68 10.02 7 393781 4157 50207179
Anuria 14.67 10.02 42 393746 11202 50200134
Hyperprolactinaemia 14.67 10.02 4 393784 3361 50207975
Dislocation of vertebra 14.58 10.02 55 393733 3032 50208304
Muscle twitching 14.58 10.02 66 393722 15365 50195971
Off label use 14.49 10.02 3371 390417 471055 49740281
Joint lock 14.42 10.02 42 393746 2023 50209313
Right ventricular failure 14.41 10.02 69 393719 15824 50195512
Klebsiella infection 14.39 10.02 21 393767 7173 50204163
Cholestasis of pregnancy 14.38 10.02 29 393759 1102 50210234
Bronchopulmonary aspergillosis 14.38 10.02 23 393765 7569 50203767
Subdural haematoma 14.36 10.02 52 393736 12895 50198441
Blood glucose decreased 14.31 10.02 83 393705 18128 50193208
Glycosylated haemoglobin increased 14.30 10.02 39 393749 10567 50200769
Human antichimeric antibody positive 14.19 10.02 34 393754 1455 50209881
Cerebral infarction 14.17 10.02 104 393684 21500 50189836
Personality disorder 14.16 10.02 8 393780 4316 50207020
Immunodeficiency 14.12 10.02 177 393611 14651 50196685
Cyst 14.08 10.02 151 393637 12036 50199300
Injection site haematoma 14.06 10.02 88 393700 5972 50205364
Product substitution issue 13.97 10.02 59 393729 13998 50197338
Sinus tachycardia 13.91 10.02 103 393685 21251 50190085
Bone disorder 13.87 10.02 214 393574 18538 50192798
Maternal exposure during breast feeding 13.77 10.02 56 393732 3198 50208138
Cervical incompetence 13.71 10.02 20 393768 582 50210754
Speech disorder developmental 13.64 10.02 20 393768 585 50210751
Dementia 13.62 10.02 71 393717 15926 50195410
Urinary incontinence 13.57 10.02 147 393641 28061 50183275
Rebound effect 13.52 10.02 4 393784 3185 50208151
Acute myocardial infarction 13.51 10.02 154 393634 29119 50182217
Coronary artery disease 13.48 10.02 157 393631 29569 50181767
Abdominal pain upper 13.43 10.02 1062 392726 158247 50053089
Product complaint 13.42 10.02 45 393743 11421 50199915
Mental disorder 13.42 10.02 108 393680 21883 50189453
Salivary hypersecretion 13.42 10.02 19 393769 6572 50204764
Disseminated tuberculosis 13.41 10.02 47 393741 2499 50208837
Antibody test positive 13.35 10.02 44 393744 2267 50209069
Eating disorder 13.34 10.02 68 393720 15341 50195995
Foot fracture 13.26 10.02 225 393563 19866 50191470
Plasma cell myeloma 13.23 10.02 168 393620 31154 50180182
Immunosuppression 13.18 10.02 101 393687 7325 50204011
Hepatic cytolysis 13.16 10.02 27 393761 8076 50203260
Mood altered 13.07 10.02 53 393735 12720 50198616
Swollen tongue 13.06 10.02 151 393637 28479 50182857
Drug abuser 13.03 10.02 3 393785 2825 50208511
Gastrointestinal disorder 12.93 10.02 877 392911 93579 50117757
Keratopathy 12.84 10.02 17 393771 451 50210885
Myopathy 12.78 10.02 33 393755 9106 50202230
Circulatory collapse 12.78 10.02 97 393691 19903 50191433
Hypertelorism 12.77 10.02 16 393772 401 50210935
Influenza 12.73 10.02 834 392954 88704 50122632
Autism spectrum disorder 12.72 10.02 21 393767 682 50210654
Pulseless electrical activity 12.70 10.02 21 393767 6820 50204516
Pneumonia viral 12.67 10.02 21 393767 6813 50204523
Visual impairment 12.58 10.02 420 393368 67855 50143481
Potentiating drug interaction 12.58 10.02 7 393781 3809 50207527
Surgery 12.58 10.02 316 393472 29889 50181447
Paranoia 12.54 10.02 40 393748 10308 50201028
Aspiration 12.54 10.02 34 393754 9230 50202106
Dystonia 12.51 10.02 49 393739 11877 50199459
Tendonitis 12.49 10.02 191 393597 16514 50194822
Foetal distress syndrome 12.48 10.02 29 393759 1216 50210120
Blood loss anaemia 12.48 10.02 28 393760 8111 50203225
Pseudomonas infection 12.47 10.02 35 393753 9395 50201941
Sleep apnoea syndrome 12.46 10.02 122 393666 23746 50187590
Catheter management 12.43 10.02 3 393785 2736 50208600
Clostridium difficile colitis 12.33 10.02 84 393704 17658 50193678
Transplant dysfunction 12.27 10.02 11 393777 4673 50206663
Catheter site pain 12.26 10.02 7 393781 3755 50207581
Visual acuity reduced 12.25 10.02 99 393689 20040 50191296
Purpura 12.23 10.02 38 393750 9873 50201463
Device breakage 12.21 10.02 36 393752 9511 50201825
Respiration abnormal 12.19 10.02 13 393775 5089 50206247
Dry skin 12.12 10.02 250 393538 42941 50168395
Sinus bradycardia 12.09 10.02 57 393731 13126 50198210
Presyncope 12.09 10.02 125 393663 24073 50187263
Pulmonary haemorrhage 11.99 10.02 20 393768 6472 50204864
Occult blood 11.98 10.02 28 393760 1179 50210157
Rash erythematous 11.89 10.02 195 393593 34657 50176679
Product prescribing error 11.87 10.02 105 393683 20856 50190480
Malignant mediastinal neoplasm 11.79 10.02 18 393770 546 50210790
Bone density abnormal 11.79 10.02 51 393737 2994 50208342
Product preparation error 11.78 10.02 10 393778 4362 50206974
Cardiotoxicity 11.76 10.02 23 393765 7004 50204332
Tonsillitis 11.74 10.02 72 393716 4851 50206485
Therapy change 11.73 10.02 14 393774 5211 50206125
Serum ferritin increased 11.73 10.02 75 393713 5127 50206209
Lymphatic fistula 11.73 10.02 21 393767 729 50210607
Bundle branch block left 11.68 10.02 19 393769 6211 50205125
Food allergy 11.68 10.02 29 393759 8108 50203228
Respiratory acidosis 11.67 10.02 18 393770 6010 50205326
Epstein-Barr virus infection 11.63 10.02 23 393765 6974 50204362
Troponin increased 11.59 10.02 29 393759 8089 50203247
Haemoglobin decreased 11.59 10.02 1145 392643 126071 50085265
Joint warmth 11.57 10.02 30 393758 1349 50209987
Drug screen positive 11.57 10.02 6 393782 3396 50207940
Wound infection 11.57 10.02 145 393643 12003 50199333
Tendon disorder 11.56 10.02 76 393712 5246 50206090
Human anti-human antibody test 11.55 10.02 15 393773 390 50210946
Hyperthyroidism 11.55 10.02 52 393736 12123 50199213
Treatment noncompliance 11.54 10.02 165 393623 29985 50181351
Eosinophil count increased 11.51 10.02 33 393755 8797 50202539
Femoral hernia incarcerated 11.51 10.02 21 393767 740 50210596
Myelosuppression 11.50 10.02 60 393728 13457 50197879
Tongue disorder 11.50 10.02 116 393672 9100 50202236
Body temperature increased 11.48 10.02 173 393615 31168 50180168
Knee operation 11.45 10.02 71 393717 4802 50206534
Multiple sclerosis 11.45 10.02 103 393685 20390 50190946
Progressive multifocal leukoencephalopathy 11.44 10.02 48 393740 11409 50199927
Hot flush 11.43 10.02 259 393529 43910 50167426
Abortion incomplete 11.42 10.02 5 393783 3121 50208215
Polydipsia 11.40 10.02 5 393783 3119 50208217
Arthritis bacterial 11.40 10.02 79 393709 5550 50205786
Ankylosing spondylitis 11.38 10.02 95 393693 7070 50204266
Dermatitis exfoliative 11.31 10.02 14 393774 5128 50206208
Somnambulism 11.27 10.02 13 393775 4911 50206425
Embedded device 11.24 10.02 4 393784 2833 50208503
Inadequate analgesia 11.23 10.02 3 393785 2555 50208781
Ulcer 11.15 10.02 220 393568 19980 50191356
Lymphocyte count decreased 11.15 10.02 141 393647 26166 50185170
Hepatotoxicity 11.14 10.02 147 393641 27079 50184257
Status epilepticus 11.14 10.02 60 393728 13346 50197990
Haemodialysis 11.09 10.02 31 393757 8331 50203005
Eye infection 11.08 10.02 117 393671 9289 50202047
Renal disorder 11.07 10.02 149 393639 27356 50183980
Wound infection pseudomonas 11 10.02 28 393760 1245 50210091
Intestinal stenosis 10.98 10.02 44 393744 2496 50208840
Hepatitis acute 10.94 10.02 29 393759 7932 50203404
Lymphadenectomy 10.93 10.02 23 393765 901 50210435
Oxygen consumption increased 10.93 10.02 7 393781 3529 50207807
Sexual dysfunction 10.91 10.02 6 393782 3286 50208050
Abortion threatened 10.89 10.02 17 393771 526 50210810
Anterior chamber cleavage syndrome 10.87 10.02 10 393778 174 50211162
Pancreatic steatosis 10.85 10.02 23 393765 906 50210430
Systemic inflammatory response syndrome 10.84 10.02 14 393774 5035 50206301
Eyelid haemangioma 10.81 10.02 4 393784 9 50211327
Ingrown hair 10.79 10.02 16 393772 473 50210863
Hereditary angioedema 10.78 10.02 16 393772 5426 50205910
Gastroenteritis 10.74 10.02 247 393541 23034 50188302
Mucormycosis 10.73 10.02 3 393785 2480 50208856
Vascular device infection 10.67 10.02 11 393777 4373 50206963
Endodontic procedure 10.64 10.02 46 393742 2700 50208636
Bone marrow failure 10.64 10.02 151 393637 27473 50183863
Exostosis 10.63 10.02 138 393650 11515 50199821
Injection site irritation 10.62 10.02 64 393724 4286 50207050
Myofascial pain syndrome 10.59 10.02 38 393750 2045 50209291
Learning disorder 10.57 10.02 18 393770 600 50210736
Dysuria 10.56 10.02 157 393631 28347 50182989
Renal tubular necrosis 10.53 10.02 42 393746 10126 50201210
Patent ductus arteriosus 10.50 10.02 58 393730 3762 50207574
Intervertebral disc degeneration 10.49 10.02 155 393633 13306 50198030
Crystal nephropathy 10.49 10.02 21 393767 794 50210542
Forceps delivery 10.46 10.02 10 393778 183 50211153
Bone lesion 10.43 10.02 15 393773 5155 50206181
Product physical issue 10.39 10.02 11 393777 4321 50207015
Nystagmus 10.39 10.02 17 393771 5544 50205792
Hallucinations, mixed 10.32 10.02 10 393778 4093 50207243
Pregnancy with contraceptive device 10.19 10.02 10 393778 4069 50207267
Cytomegalovirus viraemia 10.17 10.02 13 393775 4696 50206640
Acute coronary syndrome 10.17 10.02 38 393750 9336 50202000
Aortic embolus 10.10 10.02 5 393783 28 50211308
Rheumatoid lung 10.10 10.02 42 393746 2423 50208913
Head injury 10.08 10.02 129 393659 23891 50187445
Hyperuricaemia 10.03 10.02 13 393775 4667 50206669

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
Rheumatoid arthritis 485.37 10.04 697 147665 31455 29394710
Drug abuse 321.28 10.04 20 148342 79863 29346302
Foetal exposure during pregnancy 281.95 10.04 563 147799 33304 29392861
Completed suicide 232.80 10.04 81 148281 90165 29336000
Toxicity to various agents 229.72 10.04 322 148040 173339 29252826
Arthralgia 200.06 10.04 1291 147071 138326 29287839
Psoriatic arthropathy 142.86 10.04 261 148101 14430 29411735
Dysmorphism 122.81 10.04 109 148253 2862 29423303
Drug interaction 108.80 10.04 565 147797 196820 29229345
Sickle cell anaemia with crisis 100.55 10.04 92 148270 2516 29423649
Premature baby 94.25 10.04 243 148119 17037 29409128
Joint swelling 93.66 10.04 494 147868 49136 29377029
Intentional overdose 93.55 10.04 38 148324 38490 29387675
Enthesopathy 81.08 10.04 97 148265 3646 29422519
Psoriasis 78.29 10.04 345 148017 31882 29394283
Exposure during pregnancy 75.72 10.04 146 148216 8408 29417757
Neonatal respiratory distress syndrome 73.28 10.04 93 148269 3717 29422448
Speech disorder developmental 72.99 10.04 67 148295 1840 29424325
Musculoskeletal stiffness 71.45 10.04 374 147988 37084 29389081
Tenosynovitis 68.47 10.04 89 148273 3644 29422521
Death 67.54 10.04 1260 147102 340824 29085341
Acute kidney injury 67.34 10.04 932 147430 264335 29161830
Hypospadias 67.01 10.04 79 148283 2923 29423242
Atrial septal defect 62.71 10.04 118 148244 6671 29419494
Foetal anticonvulsant syndrome 61.08 10.04 49 148313 1115 29425050
Blood pressure fluctuation 61.05 10.04 229 148133 19665 29406500
Drug reaction with eosinophilia and systemic symptoms 59.67 10.04 33 148329 27959 29398206
Appendicolith 59.25 10.04 80 148282 3400 29422765
Overdose 58.97 10.04 204 148158 79615 29346550
Nasopharyngitis 56.01 10.04 500 147862 59165 29367000
Maternal drugs affecting foetus 53.77 10.04 81 148281 3812 29422353
Product use in unapproved indication 53.36 10.04 239 148123 86636 29339529
Autism spectrum disorder 53.05 10.04 58 148304 1974 29424191
Maternal exposure during pregnancy 53.03 10.04 83 148279 4040 29422125
Serotonin syndrome 51.98 10.04 12 148350 17500 29408665
Cryptorchism 51.69 10.04 56 148306 1886 29424279
Rhabdomyolysis 51.55 10.04 146 148216 60662 29365503
Synovitis 51.20 10.04 145 148217 10745 29415420
Tuberculosis 50.93 10.04 112 148250 7084 29419081
Febrile neutropenia 50.71 10.04 342 148020 111898 29314267
Low birth weight baby 50.38 10.04 106 148256 6502 29419663
Small for dates baby 50.19 10.04 75 148287 3504 29422661
Suicide attempt 49.33 10.04 59 148303 34051 29392114
Coma 49.22 10.04 76 148286 39374 29386791
Pain 48.64 10.04 1164 147198 170268 29255897
Learning disorder 47.31 10.04 40 148322 982 29425183
Hypoglycaemia neonatal 46.39 10.04 50 148312 1674 29424491
C-reactive protein abnormal 45.43 10.04 101 148261 6435 29419730
Maternal exposure during breast feeding 43.36 10.04 45 148317 1441 29424724
Arthritis 43.10 10.04 243 148119 24776 29401389
Drug dependence 42.92 10.04 26 148336 20955 29405210
Haemoglobin decreased 42.54 10.04 772 147590 107603 29318562
Hepatic function abnormal 42.27 10.04 83 148279 39176 29386989
Ventricular septal defect 41.22 10.04 68 148294 3461 29422704
Tongue disorder 40.87 10.04 79 148283 4557 29421608
Blood pressure systolic increased 39.89 10.04 179 148183 16666 29409499
Syndactyly 39.34 10.04 32 148330 743 29425422
Respiratory arrest 39.18 10.04 43 148319 25790 29400375
Basal cell carcinoma 38.78 10.04 178 148184 16732 29409433
Developmental delay 38.55 10.04 55 148307 2463 29423702
Appendicitis 37.53 10.04 113 148249 8666 29417499
Foot deformity 37.35 10.04 70 148292 3945 29422220
Intentional product misuse 36.70 10.04 74 148288 34587 29391578
Jaundice neonatal 36.59 10.04 38 148324 1218 29424947
Angioedema 36.54 10.04 65 148297 31850 29394315
Rheumatoid nodule 34.94 10.04 48 148314 2074 29424091
Exposure via breast milk 34.86 10.04 43 148319 1669 29424496
Drug resistance 34.76 10.04 34 148328 21506 29404659
Drug withdrawal syndrome 34.45 10.04 24 148338 17960 29408205
Arthropathy 34.30 10.04 205 148157 21349 29404816
Lower respiratory tract infection 34.16 10.04 239 148123 26263 29399902
Renal failure 33.55 10.04 407 147955 118192 29307973
Joint laxity 32.89 10.04 22 148340 374 29425791
Pulmonary fibrosis 32.80 10.04 160 148202 15422 29410743
Cardiac failure 32.67 10.04 248 148114 79039 29347126
Osteoarthritis 31.96 10.04 177 148185 17926 29408239
Alanine aminotransferase abnormal 31.91 10.04 55 148307 2902 29423263
Congenital hand malformation 31.65 10.04 25 148337 556 29425609
Bradycardia 31.64 10.04 196 148166 65433 29360732
Pancytopenia 31.07 10.04 588 147774 82580 29343585
Delirium 30.93 10.04 98 148264 39299 29386866
Intellectual disability 30.63 10.04 33 148329 1104 29425061
Agitation 30.38 10.04 143 148219 51161 29375004
Talipes 30.21 10.04 41 148321 1751 29424414
Hypermobility syndrome 30.00 10.04 20 148342 338 29425827
Palmar-plantar erythrodysaesthesia syndrome 29.21 10.04 19 148343 14740 29411425
Drug intolerance 29.20 10.04 371 147991 48008 29378157
Tendonitis 29.03 10.04 97 148265 7864 29418301
Language disorder 28.84 10.04 42 148320 1917 29424248
Blood pressure systolic abnormal 28.48 10.04 44 148318 2117 29424048
Infusion related reaction 28.41 10.04 341 148021 43545 29382620
Foetal growth restriction 28.23 10.04 60 148302 3706 29422459
Cardiac arrest 27.23 10.04 286 148076 85305 29340860
Hyperglycaemia 27.12 10.04 85 148277 34202 29391963
Cytomegalovirus infection 26.83 10.04 47 148315 23168 29402997
Suicidal ideation 26.80 10.04 87 148275 34629 29391536
Somnolence 26.72 10.04 322 148040 93633 29332532
Peripheral swelling 26.39 10.04 458 147904 63281 29362884
Large for dates baby 26.13 10.04 27 148335 860 29425305
Plagiocephaly 26.06 10.04 21 148341 481 29425684
Pain in extremity 25.78 10.04 731 147631 109702 29316463
Astigmatism 25.72 10.04 28 148334 948 29425217
Poisoning 25.68 10.04 9 148353 9984 29416181
Blood pressure increased 25.27 10.04 515 147847 73288 29352877
Polyarthritis 25.24 10.04 59 148303 3886 29422279
Hypoglycaemia 25.09 10.04 141 148221 48205 29377960
Joint effusion 25.07 10.04 61 148301 4123 29422042
Pulmonary tuberculosis 24.89 10.04 62 148300 4253 29421912
Motor developmental delay 24.89 10.04 23 148339 637 29425528
Hyperbilirubinaemia neonatal 24.45 10.04 24 148338 718 29425447
Altered state of consciousness 24.15 10.04 39 148323 19850 29406315
Knee deformity 24.02 10.04 21 148341 540 29425625
Serum ferritin increased 23.96 10.04 72 148290 5516 29420649
Substance abuse 23.76 10.04 3 148359 6784 29419381
Selective eating disorder 23.53 10.04 35 148327 1628 29424537
Body temperature decreased 23.53 10.04 111 148251 10553 29415612
Urticaria 23.45 10.04 169 148193 54491 29371674
Dysgraphia 23.44 10.04 39 148323 1999 29424166
Musculoskeletal pain 23.35 10.04 235 148127 28718 29397447
Neuroleptic malignant syndrome 23.27 10.04 28 148334 16120 29410045
Pathogen resistance 23.23 10.04 6 148356 8110 29418055
Disease progression 22.81 10.04 282 148080 81634 29344531
Otitis media 22.68 10.04 44 148318 2545 29423620
Renal impairment 22.65 10.04 280 148082 81053 29345112
Toxic epidermal necrolysis 22.61 10.04 35 148327 18118 29408047
Scoliosis 22.53 10.04 41 148321 2259 29423906
Blood pressure diastolic decreased 22.52 10.04 82 148280 6940 29419225
Blood creatine phosphokinase increased 22.49 10.04 116 148246 40528 29385637
Shock 22.39 10.04 46 148316 21358 29404807
Caesarean section 22.39 10.04 37 148325 1886 29424279
Hand deformity 22.18 10.04 39 148323 2091 29424074
Neck mass 22.16 10.04 32 148330 1449 29424716
Drug withdrawal syndrome neonatal 21.97 10.04 51 148311 3344 29422821
Behaviour disorder 21.97 10.04 53 148309 3563 29422602
Hypotonia neonatal 21.88 10.04 29 148333 1210 29424955
Skin cancer 21.58 10.04 92 148270 8376 29417789
Knee arthroplasty 21.38 10.04 71 148291 5738 29420427
Sedation 21.26 10.04 34 148328 17371 29408794
Rash maculo-papular 20.81 10.04 58 148304 24231 29401934
Loss of personal independence in daily activities 20.76 10.04 207 148155 25233 29400932
Blood pressure diastolic abnormal 20.72 10.04 42 148320 2509 29423656
Strabismus 20.32 10.04 30 148332 1386 29424779
Hypertelorism 20.16 10.04 19 148343 540 29425625
Low set ears 20.01 10.04 17 148345 420 29425745
Cleft lip 19.88 10.04 15 148347 311 29425854
Attention deficit hyperactivity disorder 19.81 10.04 38 148324 2179 29423986
Medical device implantation 19.70 10.04 19 148343 556 29425609
Dyslexia 19.64 10.04 15 148347 317 29425848
Depressed level of consciousness 19.57 10.04 107 148255 36835 29389330
Hydrocele 19.36 10.04 35 148327 1918 29424247
Crohn's disease 19.25 10.04 45 148317 2964 29423201
Anal atresia 19.24 10.04 14 148348 274 29425891
Dyspraxia 19.19 10.04 16 148346 385 29425780
Agitation neonatal 19.09 10.04 25 148337 1031 29425134
Toxic optic neuropathy 19.08 10.04 21 148341 720 29425445
Arthritis bacterial 19.05 10.04 57 148305 4356 29421809
Vitamin B12 deficiency 18.87 10.04 47 148315 3224 29422941
Hepatic cyst 18.55 10.04 38 148324 2287 29423878
Off label use 18.17 10.04 1282 147080 299518 29126647
Bradycardia neonatal 18.16 10.04 23 148339 917 29425248
Foetal disorder 18.13 10.04 21 148341 762 29425403
Malignant neoplasm progression 18.11 10.04 261 148101 73598 29352567
Lactic acidosis 18.08 10.04 84 148278 30163 29396002
Patent ductus arteriosus 18.08 10.04 45 148317 3086 29423079
Anal fistula 17.94 10.04 54 148308 4141 29422024
Juvenile idiopathic arthritis 17.84 10.04 28 148334 1366 29424799
Lacrimal disorder 17.81 10.04 14 148348 309 29425856
Heart rate decreased 17.65 10.04 197 148165 24715 29401450
Congenital bladder anomaly 17.63 10.04 13 148349 260 29425905
Limb reduction defect 17.58 10.04 13 148349 261 29425904
Congenital anomaly 17.45 10.04 27 148335 1301 29424864
Weight decrease neonatal 17.43 10.04 14 148348 319 29425846
Bronchiolitis 17.41 10.04 41 148321 2714 29423451
Renal aplasia 17.37 10.04 19 148343 647 29425518
Vitamin D deficiency 17.25 10.04 64 148298 5465 29420700
C-reactive protein increased 17.23 10.04 315 148047 43948 29382217
Congenital foot malformation 17.15 10.04 15 148347 386 29425779
Back disorder 16.88 10.04 67 148295 5906 29420259
Hepatic failure 16.84 10.04 91 148271 31421 29394744
Ankyloglossia congenital 16.65 10.04 13 148349 284 29425881
Hepatic enzyme increased 16.65 10.04 250 148112 33549 29392616
Venoocclusive liver disease 16.50 10.04 7 148355 6910 29419255
Accessory spleen 16.44 10.04 10 148352 143 29426022
Psychomotor retardation 16.37 10.04 42 148320 2934 29423231
Inflammation 16.22 10.04 180 148182 22548 29403617
Spinal disorder 16.21 10.04 48 148314 3647 29422518
Haemangioma congenital 16.18 10.04 16 148346 483 29425682
Post procedural infection 16.18 10.04 53 148309 4252 29421913
Finger deformity 16.14 10.04 24 148338 1116 29425049
Weight decreased 16.11 10.04 918 147444 149987 29276178
Anticonvulsant drug level above therapeutic 16.07 10.04 17 148345 557 29425608
Acute hepatic failure 15.91 10.04 22 148340 11930 29414235
Diaphragmatic disorder 15.85 10.04 22 148340 960 29425205
Colitis ulcerative 15.78 10.04 114 148248 12655 29413510
Nasal disorder 15.70 10.04 27 148335 1422 29424743
Wound 15.67 10.04 109 148253 11954 29414211
Intentional self-injury 15.54 10.04 24 148338 12437 29413728
Microcephaly 15.53 10.04 19 148343 731 29425434
Mouth ulceration 15.53 10.04 97 148265 10258 29415907
Multiple congenital abnormalities 15.53 10.04 16 148346 508 29425657
Arthrodesis 15.44 10.04 15 148347 443 29425722
Pyrexia 15.43 10.04 1238 147124 286384 29139781
Malignant melanoma 15.41 10.04 74 148288 7087 29419078
Blood pressure diastolic increased 15.34 10.04 47 148315 3639 29422526
Incorrect route of product administration 15.28 10.04 19 148343 10782 29415383
Respiratory rate increased 15.27 10.04 85 148277 8623 29417542
Pectus excavatum 15.26 10.04 11 148351 212 29425953
Injection site pain 15.21 10.04 238 148124 32208 29393957
Stevens-Johnson syndrome 15.19 10.04 38 148324 16459 29409706
Haemangioma 15.10 10.04 29 148333 1665 29424500
Cerebral haemorrhage 15.06 10.04 94 148268 31332 29394833
Tachycardia 15.03 10.04 264 148098 72146 29354019
Umbilical hernia 14.96 10.04 47 148315 3688 29422477
Septic arthritis staphylococcal 14.77 10.04 15 148347 468 29425697
Polydactyly 14.73 10.04 23 148339 1117 29425048
Hypotension 14.73 10.04 811 147551 193543 29232622
Respiratory disorder neonatal 14.72 10.04 26 148336 1399 29424766
Oesophageal fibrosis 14.65 10.04 10 148352 176 29425989
Foetal heart rate deceleration abnormality 14.61 10.04 15 148347 474 29425691
Haematocrit decreased 14.42 10.04 215 148147 28807 29397358
C-reactive protein decreased 14.38 10.04 27 148335 1524 29424641
Joint stiffness 14.37 10.04 89 148273 9384 29416781
Stress 14.35 10.04 168 148194 21322 29404843
Product quality issue 14.34 10.04 37 148325 15858 29410307
Lung neoplasm malignant 14.33 10.04 122 148240 14235 29411930
Diverticular perforation 14.29 10.04 40 148322 2944 29423221
Grip strength decreased 14.22 10.04 34 148328 2273 29423892
Ear infection 14.16 10.04 79 148283 8021 29418144
Ear disorder 14.15 10.04 24 148338 1250 29424915
Joint range of motion decreased 14.08 10.04 64 148298 5990 29420175
Microphthalmos 14.04 10.04 10 148352 189 29425976
Maternal exposure timing unspecified 14.04 10.04 13 148349 361 29425804
Hallucination 13.97 10.04 150 148212 44562 29381603
Infective pulmonary exacerbation of cystic fibrosis 13.81 10.04 7 148355 6229 29419936
Progressive multifocal leukoencephalopathy 13.79 10.04 14 148348 8705 29417460
Aggression 13.78 10.04 113 148249 35428 29390737
Arnold-Chiari malformation 13.75 10.04 12 148350 308 29425857
Ankylosing spondylitis 13.59 10.04 49 148313 4127 29422038
Hernia pain 13.54 10.04 11 148351 255 29425910
Immunodeficiency 13.53 10.04 51 148311 4389 29421776
Respiratory depression 13.37 10.04 30 148332 13493 29412672
General physical health deterioration 13.25 10.04 637 147725 102220 29323945
Red blood cell sedimentation rate increased 13.20 10.04 73 148289 7388 29418777
Cellulitis 13.17 10.04 312 148050 45528 29380637
Wrong technique in product usage process 13.08 10.04 98 148264 31330 29394835
Maternal exposure before pregnancy 12.96 10.04 14 148348 470 29425695
Vascular insufficiency 12.94 10.04 12 148350 334 29425831
Cholelithiasis 12.93 10.04 147 148215 18525 29407640
Poor venous access 12.87 10.04 40 148322 3121 29423044
Emphysema 12.86 10.04 81 148281 8590 29417575
Tooth malformation 12.78 10.04 9 148353 167 29425998
Second primary malignancy 12.77 10.04 9 148353 6696 29419469
Spina bifida 12.70 10.04 12 148350 342 29425823
Foetal distress syndrome 12.69 10.04 20 148342 979 29425186
Radiation inflammation 12.67 10.04 10 148352 222 29425943
No adverse event 12.67 10.04 45 148317 17433 29408732
Injection site bruising 12.64 10.04 73 148289 7507 29418658
Injection site rash 12.62 10.04 43 148319 3521 29422644
Blood parathyroid hormone decreased 12.62 10.04 18 148344 806 29425359
Aspergillus infection 12.61 10.04 21 148341 10560 29415605
Blood insulin increased 12.56 10.04 12 148350 347 29425818
Red blood cell count decreased 12.46 10.04 189 148173 25413 29400752
Cleft palate 12.43 10.04 15 148347 569 29425596
Developmental coordination disorder 12.38 10.04 9 148353 176 29425989
Osteonecrosis of jaw 12.31 10.04 42 148320 16468 29409697
Disseminated intravascular coagulation 12.23 10.04 55 148307 19925 29406240
Inguinal hernia 12.21 10.04 66 148296 6622 29419543
Sexual dysfunction 12.18 10.04 7 148355 5807 29420358
Unresponsive to stimuli 12.12 10.04 75 148287 25051 29401114
Ear malformation 12.11 10.04 11 148351 298 29425867
Pleural fibrosis 12.08 10.04 23 148339 1312 29424853
Pancreatic calcification 12.08 10.04 9 148353 183 29425982
Excessive eye blinking 12.02 10.04 13 148349 437 29425728
Blood albumin decreased 12.00 10.04 100 148262 11595 29414570
Obsessive-compulsive disorder 11.97 10.04 4 148358 4572 29421593
Palindromic rheumatism 11.95 10.04 9 148353 186 29425979
Diabetic ketoacidosis 11.91 10.04 41 148321 16032 29410133
Psychotic disorder 11.88 10.04 57 148305 20297 29405868
Hypertriglyceridaemia 11.83 10.04 12 148350 7463 29418702
Latent tuberculosis 11.83 10.04 20 148342 1039 29425126
Immune reconstitution inflammatory syndrome 11.81 10.04 13 148349 7789 29418376
Subdural haematoma 11.80 10.04 49 148313 18144 29408021
Arthritis infective 11.74 10.04 36 148326 2788 29423377
Peripheral artery thrombosis 11.73 10.04 30 148332 2092 29424073
Congenital hydronephrosis 11.72 10.04 16 148346 687 29425478
Neurotoxicity 11.71 10.04 36 148326 14577 29411588
Gangrene neonatal 11.71 10.04 9 148353 192 29425973
Akathisia 11.64 10.04 10 148352 6732 29419433
Hyperammonaemia 11.61 10.04 7 148355 5656 29420509
Injection site swelling 11.59 10.04 84 148278 9333 29416832
Mean cell volume increased 11.56 10.04 33 148329 2456 29423709
Prostate cancer 11.50 10.04 186 148176 25341 29400824
Chronic graft versus host disease 11.49 10.04 3 148359 4026 29422139
Suspected suicide 11.45 10.04 3 148359 4017 29422148
Red blood cell sedimentation rate 11.42 10.04 14 148348 540 29425625
Excessive cerumen production 11.41 10.04 10 148352 258 29425907
Drug ineffective for unapproved indication 11.40 10.04 35 148327 14179 29411986
Pharyngeal disorder 11.39 10.04 15 148347 622 29425543
Infection 11.33 10.04 482 147880 76269 29349896
Necrotising enterocolitis neonatal 11.32 10.04 9 148353 202 29425963
Neonatal seizure 11.24 10.04 13 148349 471 29425694
Pulmonary artery stenosis congenital 11.20 10.04 13 148349 473 29425692
Pyelocaliectasis 11.16 10.04 20 148342 1089 29425076
Neonatal infection 11.15 10.04 12 148350 401 29425764
Meningeal disorder 11.13 10.04 11 148351 332 29425833
Skin lesion 11.02 10.04 142 148220 18430 29407735
Contraindicated product administered 10.98 10.04 140 148222 18126 29408039
Respiratory failure 10.91 10.04 388 147974 96743 29329422
Therapeutic product effect decreased 10.91 10.04 208 148154 29243 29396922
Akinesia 10.86 10.04 28 148334 1962 29424203
Acute graft versus host disease 10.86 10.04 8 148354 5816 29420349
Hypermethioninaemia 10.84 10.04 3 148359 3 29426162
Nephrolithiasis 10.82 10.04 183 148179 25151 29401014
Fine motor skill dysfunction 10.82 10.04 24 148338 1527 29424638
Anaemia vitamin B12 deficiency 10.79 10.04 10 148352 278 29425887
Upper respiratory tract infection 10.77 10.04 195 148167 27154 29399011
Nail bed inflammation 10.76 10.04 8 148354 162 29426003
Hypoxia 10.72 10.04 170 148192 47209 29378956
Agranulocytosis 10.72 10.04 59 148303 20281 29405884
Abdominal distension 10.72 10.04 304 148058 45607 29380558
Synovial cyst 10.67 10.04 27 148335 1870 29424295
Anti-erythropoietin antibody positive 10.63 10.04 17 148345 843 29425322
Pneumonia 10.59 10.04 1793 146569 318379 29107786
Ventricular tachycardia 10.57 10.04 68 148294 22506 29403659
Prominent epicanthal folds 10.56 10.04 8 148354 167 29425998
Granulocyte count increased 10.53 10.04 11 148351 355 29425810
Kidney infection 10.52 10.04 49 148313 4634 29421531
Appendix disorder 10.42 10.04 14 148348 592 29425573
Steatorrhoea 10.39 10.04 15 148347 679 29425486
Withdrawal syndrome 10.37 10.04 25 148337 10967 29415198
Decreased appetite 10.36 10.04 610 147752 144732 29281433
Educational problem 10.35 10.04 13 148349 514 29425651
Peritoneal dialysis complication 10.35 10.04 24 148338 1573 29424592
Iris hypopigmentation 10.31 10.04 5 148357 44 29426121
Non-Hodgkin's lymphoma 10.25 10.04 23 148339 1474 29424691
Foetal hypokinesia 10.24 10.04 11 148351 367 29425798
Bronchopulmonary aspergillosis 10.19 10.04 30 148332 12314 29413851
Lung neoplasm 10.18 10.04 46 148316 4294 29421871
Lung cancer metastatic 10.15 10.04 31 148331 2396 29423769
Back pain 10.09 10.04 618 147744 101666 29324499
Gaze palsy 10.09 10.04 21 148341 1278 29424887
Pancreatic duct stenosis 10.09 10.04 8 148354 179 29425986
Neutropenia 10.07 10.04 549 147813 131162 29295003
Oxygen saturation decreased 10.06 10.04 296 148066 44641 29381524

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
Rheumatoid arthritis 1202.57 9.87 2979 404898 161315 63929540
Completed suicide 949.97 9.87 143 407734 224271 63866584
Pemphigus 764.47 9.87 1375 406502 59326 64031529
Arthropathy 758.68 9.87 2071 405806 118896 63971959
Toxicity to various agents 747.18 9.87 719 407158 362794 63728061
Systemic lupus erythematosus 736.19 9.87 1560 406317 76052 64014803
Joint swelling 719.22 9.87 2981 404896 212401 63878454
Hand deformity 706.67 9.87 1355 406522 61416 64029439
Synovitis 674.44 9.87 1749 406128 97341 63993514
Glossodynia 649.30 9.87 1331 406546 63365 64027490
Drug abuse 646.97 9.87 50 407827 132324 63958531
Arthralgia 629.78 9.87 4864 403013 437396 63653459
Maternal exposure during pregnancy 613.48 9.87 1654 406223 94230 63996625
Infusion related reaction 554.68 9.87 2284 405593 162183 63928672
Anti-cyclic citrullinated peptide antibody positive 529.91 9.87 1047 406830 48515 64042340
Wound 516.28 9.87 1346 406531 75131 64015724
Pericarditis 496.63 9.87 1171 406706 61345 64029510
Pain 448.14 9.87 5405 402472 548106 63542749
Abdominal discomfort 438.05 9.87 2293 405584 180029 63910826
Alopecia 399.46 9.87 2086 405791 163604 63927251
Swelling 377.90 9.87 2005 405872 158213 63932642
Nasopharyngitis 370.48 9.87 2313 405564 193760 63897095
Therapeutic product effect decreased 366.86 9.87 1574 406303 113777 63977078
Drug interaction 365.50 9.87 1127 406750 360956 63729899
Contraindicated product administered 355.81 9.87 1488 406389 106341 63984514
Discomfort 350.06 9.87 1217 406660 79661 64011194
Death 336.06 9.87 1741 406136 480964 63609891
Exposure during pregnancy 330.29 9.87 1162 406715 76513 64014342
Intentional overdose 322.50 9.87 85 407792 89859 64000996
Rheumatoid factor positive 314.70 9.87 688 407189 34250 64056605
Duodenal ulcer perforation 305.27 9.87 676 407201 33949 64056906
Helicobacter infection 303.96 9.87 718 407159 37644 64053211
Drug intolerance 296.21 9.87 2120 405757 185872 63904983
Musculoskeletal stiffness 292.56 9.87 1545 406332 121661 63969194
Hepatic enzyme increased 288.63 9.87 1600 406277 128343 63962512
Acute kidney injury 246.44 9.87 1746 406131 447494 63643361
Psoriatic arthropathy 234.08 9.87 703 407174 42578 64048277
Febrile neutropenia 230.02 9.87 530 407347 187127 63903728
Overdose 222.23 9.87 419 407458 159147 63931708
C-reactive protein abnormal 220.77 9.87 535 407342 28512 64062343
Cardiac arrest 209.79 9.87 410 407467 153654 63937201
Sinusitis 206.12 9.87 1604 406273 144324 63946531
Impaired healing 198.17 9.87 833 407044 59640 64031215
Lower respiratory tract infection 184.63 9.87 1126 406751 93488 63997367
Red blood cell sedimentation rate abnormal 180.92 9.87 350 407527 15956 64074899
Product use issue 180.27 9.87 1604 406273 150111 63940744
Peripheral swelling 180.07 9.87 2069 405808 207084 63883771
Treatment failure 172.17 9.87 1297 406580 115519 63975336
Hypersensitivity 171.64 9.87 1949 405928 194503 63896352
Depressed level of consciousness 170.46 9.87 158 407719 81278 64009577
Muscle injury 166.84 9.87 454 407423 25983 64064872
Blood pressure fluctuation 164.14 9.87 707 407170 51164 64039691
Sickle cell anaemia with crisis 161.97 9.87 184 407693 5148 64085707
Arthritis 160.07 9.87 992 406885 82822 64008033
Respiratory arrest 157.12 9.87 69 407808 52916 64037939
Bradycardia 154.59 9.87 322 407555 117897 63972958
Suicide attempt 154.33 9.87 133 407744 70874 64019981
Hip arthroplasty 149.34 9.87 381 407496 20970 64069885
Folliculitis 148.21 9.87 473 407404 29604 64061251
Knee arthroplasty 144.52 9.87 437 407440 26562 64064293
Irritable bowel syndrome 144.35 9.87 542 407335 36827 64054028
Rhabdomyolysis 144.04 9.87 223 407654 91503 63999352
Sleep disorder due to general medical condition, insomnia type 143.26 9.87 428 407449 25842 64065013
Pregnancy 141.47 9.87 368 407509 20497 64070358
Psoriasis 140.28 9.87 854 407023 70849 64020006
Drug ineffective 135.95 9.87 6551 401326 833696 63257159
Cardiac failure 133.96 9.87 411 407466 131962 63958893
Drug reaction with eosinophilia and systemic symptoms 133.90 9.87 89 407788 54128 64036727
Abortion spontaneous 133.68 9.87 406 407471 24737 64066118
Osteoarthritis 132.67 9.87 768 407109 62568 64028287
Weight increased 131.91 9.87 1987 405890 211361 63879494
Sopor 129.79 9.87 17 407860 29644 64061211
Sedation 122.92 9.87 54 407823 41408 64049447
Renal failure 121.71 9.87 663 407214 181025 63909830
Blister 120.97 9.87 902 406975 80065 64010790
Injection site erythema 118.69 9.87 811 407066 69989 64020866
Lactic acidosis 117.26 9.87 129 407748 61281 64029574
Malignant neoplasm progression 112.39 9.87 353 407524 112518 63978337
Hepatic function abnormal 109.18 9.87 148 407729 64165 64026690
Infection 105.52 9.87 1699 406178 183181 63907674
Serotonin syndrome 103.21 9.87 60 407817 39222 64051633
Drug dependence 99.36 9.87 43 407834 33269 64057586
Hypotension 99.34 9.87 1753 406124 379221 63711634
Enthesopathy 98.63 9.87 200 407677 9438 64081417
Agitation 98.47 9.87 262 407615 88105 64002750
Blood pressure systolic increased 97.98 9.87 591 407286 48862 64041993
Disease progression 97.64 9.87 512 407365 141168 63949687
Hypoglycaemia 97.55 9.87 270 407607 89622 64001233
Neutropenia 96.31 9.87 1009 406868 238615 63852240
Ill-defined disorder 94.75 9.87 538 407339 43514 64047341
Contusion 94.22 9.87 1119 406758 112846 63978009
Coma 93.71 9.87 265 407612 87350 64003505
Red blood cell sedimentation rate increased 93.68 9.87 419 407458 30816 64060039
Fatigue 93.46 9.87 5700 402177 743030 63347825
Injection site pruritus 92.88 9.87 479 407398 37347 64053508
Cardio-respiratory arrest 89.54 9.87 320 407557 98073 63992782
Cytomegalovirus infection 89.28 9.87 63 407814 37136 64053719
Intentional product misuse 87.03 9.87 206 407671 72089 64018766
Drug resistance 86.17 9.87 58 407819 35044 64055811
Injection site pain 86.07 9.87 1080 406797 110328 63980527
Juvenile idiopathic arthritis 85.68 9.87 114 407763 3765 64087090
Joint effusion 85.63 9.87 232 407645 13241 64077614
Blood pressure diastolic abnormal 84.73 9.87 214 407663 11703 64079152
Live birth 82.61 9.87 204 407673 11000 64079855
Somnolence 82.43 9.87 856 407021 202789 63888066
Renal impairment 82.19 9.87 508 407369 134509 63956346
Hyperglycaemia 80.57 9.87 165 407712 60803 64030052
Pain in extremity 80.55 9.87 2497 405380 300588 63790267
Product use in unapproved indication 80.53 9.87 721 407156 175897 63914958
Respiratory failure 79.76 9.87 644 407233 160539 63930316
Blood pressure systolic abnormal 79.72 9.87 187 407690 9755 64081100
Rheumatic fever 78.03 9.87 178 407699 9116 64081739
Disability assessment scale score increased 78.03 9.87 88 407789 2442 64088413
Injection site swelling 76.77 9.87 486 407391 40867 64049988
Osteoporosis 76.54 9.87 492 407385 41588 64049267
Rheumatoid nodule 75.60 9.87 213 407664 12438 64078417
Caesarean section 74.54 9.87 197 407680 11077 64079778
Injection site reaction 74.35 9.87 528 407349 46136 64044719
Poisoning 74.11 9.87 23 407854 21856 64068999
Hepatic failure 73.98 9.87 149 407728 55245 64035610
Disseminated intravascular coagulation 73.48 9.87 58 407819 32290 64058565
Condition aggravated 72.91 9.87 2963 404914 369463 63721392
Blood pressure diastolic decreased 72.88 9.87 307 407570 21994 64068861
Tenosynovitis 72.46 9.87 201 407676 11632 64079223
Musculoskeletal pain 72.45 9.87 810 407067 80484 64010371
Swollen joint count increased 72.18 9.87 154 407723 7535 64083320
Tachycardia 72.02 9.87 602 407275 148977 63941878
Intentional self-injury 71.28 9.87 48 407829 28996 64061859
Foot deformity 71.04 9.87 248 407629 16256 64074599
Tuberculosis 70.68 9.87 212 407665 12826 64078029
Rash 69.74 9.87 3556 404321 454993 63635862
Grip strength decreased 69.68 9.87 197 407680 11527 64079328
Fibromyalgia 69.50 9.87 425 407452 35306 64055549
Delirium 69.14 9.87 216 407661 68978 64021877
Shock 69.03 9.87 84 407793 38156 64052699
Device expulsion 68.46 9.87 24 407853 21112 64069743
Hypoxia 67.99 9.87 306 407571 87843 64003012
Drug withdrawal syndrome 67.51 9.87 59 407818 31232 64059623
Joint laxity 65.50 9.87 77 407800 2237 64088618
Heart rate decreased 64.70 9.87 581 407296 54486 64036369
Altered state of consciousness 64.55 9.87 87 407790 37815 64053040
Respiratory depression 62.74 9.87 35 407842 23408 64067447
Angioedema 62.47 9.87 192 407685 61629 64029226
Syncope 61.58 9.87 668 407209 156967 63933888
Joint stiffness 61.27 9.87 365 407512 30039 64060816
Blood pressure increased 60.92 9.87 1475 406402 171077 63919778
Cardiac failure congestive 60.85 9.87 530 407347 130050 63960805
Cerebral haemorrhage 59.58 9.87 148 407729 50942 64039913
Localised infection 59.45 9.87 360 407517 29801 64061054
Constipation 59.44 9.87 1056 406821 228281 63862574
Basal cell carcinoma 58.84 9.87 365 407512 30473 64060382
C-reactive protein increased 58.20 9.87 883 406994 94026 63996829
Gastrointestinal disorder 57.89 9.87 842 407035 88867 64001988
Injection site bruising 57.62 9.87 411 407466 35962 64054893
Neoplasm progression 57.47 9.87 107 407770 40857 64049998
Oropharyngeal pain 57.31 9.87 834 407043 88033 64002822
Blood creatine phosphokinase increased 56.96 9.87 185 407692 58373 64032482
Premature delivery 56.22 9.87 250 407627 18339 64072516
Inflammation 56.09 9.87 646 407231 64654 64026201
Femur fracture 56.00 9.87 389 407488 33746 64057109
Polyarthritis 55.56 9.87 161 407716 9554 64081301
Bone erosion 54.99 9.87 180 407697 11415 64079440
Gestational diabetes 54.84 9.87 114 407763 5476 64085379
Cholestasis 54.69 9.87 127 407750 44745 64046110
Multiple organ dysfunction syndrome 53.04 9.87 399 407478 101014 63989841
Hypothermia 52.63 9.87 30 407847 19826 64071029
Tongue disorder 52.41 9.87 182 407695 11898 64078957
Hepatocellular injury 52.00 9.87 132 407745 45103 64045752
Loss of personal independence in daily activities 51.99 9.87 693 407184 71761 64019094
Injection site rash 50.89 9.87 216 407661 15526 64075329
Cognitive disorder 50.88 9.87 178 407699 54909 64035946
Body temperature decreased 50.80 9.87 309 407568 25619 64065236
Metabolic acidosis 50.80 9.87 253 407624 70705 64020150
Tremor 50.24 9.87 648 407229 147582 63943273
Thrombocytopenia 50.20 9.87 1056 406821 222745 63868110
Hyperhidrosis 50.13 9.87 526 407351 124394 63966461
Myocardial infarction 49.75 9.87 743 407134 165078 63925777
Neuroleptic malignant syndrome 49.39 9.87 51 407826 24945 64065910
Nodule 48.83 9.87 234 407643 17713 64073142
Mydriasis 48.55 9.87 18 407859 15294 64075561
Blood pressure diastolic increased 48.40 9.87 164 407713 10588 64080267
Post transplant lymphoproliferative disorder 48.35 9.87 3 407874 9541 64081314
Maternal exposure before pregnancy 47.82 9.87 82 407795 3401 64087454
Ventricular tachycardia 47.63 9.87 90 407787 34175 64056680
Sedation complication 47.62 9.87 5 407872 10349 64080506
Hyperkalaemia 47.32 9.87 410 407467 100719 63990136
Encephalopathy 47.28 9.87 201 407676 58618 64032237
Hyponatraemia 47.18 9.87 657 407220 147682 63943173
Tendonitis 47.15 9.87 253 407624 20029 64070826
Pre-eclampsia 46.52 9.87 114 407763 6117 64084738
Myalgia 46.46 9.87 714 407163 157903 63932952
Stomatitis 45.58 9.87 959 406918 108646 63982209
Appendicolith 45.45 9.87 80 407797 3389 64087466
Neck mass 45.10 9.87 87 407790 3957 64086898
Hallucination 43.69 9.87 275 407602 72513 64018342
Pulmonary fibrosis 43.55 9.87 331 407546 29547 64061308
Premature labour 43.30 9.87 126 407751 7494 64083361
Venoocclusive liver disease 43.20 9.87 6 407871 10009 64080846
Posterior reversible encephalopathy syndrome 42.92 9.87 49 407828 22897 64067958
Joint destruction 42.74 9.87 80 407797 3556 64087299
Mental status changes 42.68 9.87 220 407657 60942 64029913
Tenderness 42.54 9.87 240 407637 19362 64071493
Speech disorder 42.44 9.87 160 407717 48281 64042574
Synovial cyst 42.42 9.87 126 407751 7581 64083274
Pulmonary tuberculosis 42.34 9.87 121 407756 7123 64083732
Anxiety 42.33 9.87 967 406910 201682 63889173
Intentional product use issue 42.16 9.87 842 407035 94522 63996333
Neck deformity 42.01 9.87 53 407824 1659 64089196
Latent tuberculosis 41.99 9.87 68 407809 2689 64088166
Herpes zoster 41.90 9.87 719 407158 78468 64012387
Diabetic ketoacidosis 41.83 9.87 78 407799 29767 64061088
Acute hepatic failure 41.43 9.87 63 407814 26049 64064806
Fracture 40.95 9.87 230 407647 18525 64072330
Laryngitis 40.94 9.87 158 407719 10873 64079982
Melaena 40.62 9.87 187 407690 53361 64037494
Restlessness 40.59 9.87 123 407754 39662 64051193
Urticaria 40.51 9.87 671 407206 146646 63944209
Disturbance in attention 40.48 9.87 129 407748 40945 64049910
Premature rupture of membranes 39.87 9.87 79 407798 3665 64087190
Palmar-plantar erythrodysaesthesia syndrome 39.79 9.87 76 407801 28743 64062112
Disorientation 39.42 9.87 200 407677 55628 64035227
Unresponsive to stimuli 39.41 9.87 174 407703 50219 64040636
Dehydration 39.40 9.87 1056 406821 215707 63875148
Orthostatic hypotension 39.26 9.87 157 407720 46581 64044274
Alanine aminotransferase abnormal 39.24 9.87 114 407763 6774 64084081
Joint injury 39.12 9.87 264 407613 22683 64068172
Red blood cell sedimentation rate 39.11 9.87 78 407799 3636 64087219
Substance abuse 39.07 9.87 6 407871 9286 64081569
Infective pulmonary exacerbation of cystic fibrosis 38.89 9.87 13 407864 11783 64079072
Pulmonary embolism 38.82 9.87 671 407206 145685 63945170
Abnormal behaviour 38.73 9.87 98 407779 33524 64057331
Dizziness 38.68 9.87 2276 405601 427887 63662968
Skin ulcer 38.64 9.87 437 407440 43537 64047318
Leukopenia 38.34 9.87 432 407445 100810 63990045
Limb deformity 38.33 9.87 73 407804 3288 64087567
Poor venous access 38.31 9.87 168 407709 12249 64078606
Dyspnoea 37.98 9.87 3973 403904 714701 63376154
Disability 37.79 9.87 165 407712 12007 64078848
Pathogen resistance 37.71 9.87 16 407861 12527 64078328
Aspergillus infection 37.67 9.87 29 407848 16350 64074505
Gastrointestinal haemorrhage 37.59 9.87 599 407278 131713 63959142
Suicidal ideation 37.11 9.87 257 407620 66285 64024570
Joint range of motion decreased 36.94 9.87 229 407648 19114 64071741
Fluid retention 36.91 9.87 223 407654 59383 64031472
Anaphylactic shock 36.83 9.87 86 407791 30242 64060613
Smear cervix abnormal 36.77 9.87 59 407818 2315 64088540
Electrocardiogram QT prolonged 36.76 9.87 323 407554 79125 64011730
Pulmonary arterial hypertension 36.71 9.87 65 407812 25302 64065553
Second primary malignancy 36.67 9.87 16 407861 12321 64078534
Product quality issue 36.59 9.87 84 407793 29715 64061140
Asphyxia 36.31 9.87 8 407869 9558 64081297
Cytokine release syndrome 36.29 9.87 47 407830 20782 64070073
Accidental overdose 36.24 9.87 101 407776 33456 64057399
Influenza 36.18 9.87 906 406971 105625 63985230
Torsade de pointes 35.95 9.87 34 407843 17329 64073526
Arthritis infective 35.95 9.87 112 407765 6918 64083937
Mouth ulceration 35.92 9.87 338 407539 32106 64058749
Rash maculo-papular 35.80 9.87 164 407713 46862 64043993
Atrial fibrillation 35.27 9.87 818 407059 170271 63920584
Cerebral infarction 35.03 9.87 137 407740 40907 64049948
Bone disorder 34.93 9.87 203 407674 16556 64074299
Myoclonus 34.89 9.87 66 407811 25052 64065803
Anaemia 34.67 9.87 2000 405877 376680 63714175
Ejection fraction decreased 34.38 9.87 82 407795 28625 64062230
Product administration error 33.88 9.87 78 407799 27565 64063290
Irritability 33.75 9.87 119 407758 36627 64054228
Aggression 33.57 9.87 164 407713 46068 64044787
Bronchitis 33.50 9.87 913 406964 107830 63983025
Multiple fractures 33.49 9.87 99 407778 5941 64084914
Neutrophil count decreased 33.48 9.87 319 407558 76877 64013978
Asthma 33.48 9.87 413 407464 94812 63996043
Arrhythmia 33.35 9.87 197 407680 52747 64038108
Respiratory distress 33.35 9.87 194 407683 52137 64038718
Spinal stenosis 33.22 9.87 175 407702 13756 64077099
Extrapyramidal disorder 33.17 9.87 45 407832 19507 64071348
Immune reconstitution inflammatory syndrome 32.82 9.87 19 407858 12451 64078404
Decreased appetite 32.80 9.87 1449 406428 279840 63811015
Multiple sclerosis relapse 32.80 9.87 141 407736 40994 64049861
Anaphylactic reaction 32.73 9.87 277 407600 68387 64022468
Oral herpes 32.62 9.87 246 407631 21906 64068949
Gastroenteritis viral 32.46 9.87 225 407652 19504 64071351
Ischaemic stroke 32.39 9.87 86 407791 28949 64061906
Asthenia 32.11 9.87 2302 405575 425742 63665113
Haematotoxicity 32.07 9.87 21 407856 12875 64077980
Diarrhoea 32.00 9.87 4043 403834 718661 63372194
Drug level increased 31.91 9.87 110 407767 34086 64056769
Acute graft versus host disease 31.77 9.87 9 407868 9075 64081780
Agranulocytosis 31.74 9.87 129 407748 38100 64052755
Bradyphrenia 31.65 9.87 10 407867 9396 64081459
Hypokalaemia 31.64 9.87 561 407316 121342 63969513
Withdrawal syndrome 31.52 9.87 63 407814 23429 64067426
Immunodeficiency 31.49 9.87 192 407685 15932 64074923
Blood glucose increased 31.30 9.87 434 407443 97639 63993216
Bronchopulmonary aspergillosis 31.30 9.87 45 407832 19040 64071815
Ear infection 31.20 9.87 254 407623 23150 64067705
Akathisia 31.07 9.87 17 407860 11493 64079362
Fear of injection 30.99 9.87 95 407782 5817 64085038
Blood cholesterol increased 30.76 9.87 466 407411 49600 64041255
Tenosynovitis stenosans 30.75 9.87 49 407828 1911 64088944
Transplant rejection 30.59 9.87 39 407838 17362 64073493
Emotional distress 30.31 9.87 121 407756 35917 64054938
Mucormycosis 30.28 9.87 5 407872 7336 64083519
Coagulopathy 30.25 9.87 102 407775 31818 64059037
Wheelchair user 30.24 9.87 81 407796 4591 64086264
Coronary artery disease 30.08 9.87 241 407636 60192 64030663
Pulmonary oedema 30.06 9.87 335 407542 78339 64012516
Rotator cuff repair 30 9.87 42 407835 1457 64089398
Neurotoxicity 29.95 9.87 82 407795 27322 64063533
Balance disorder 29.88 9.87 363 407514 83563 64007292
Therapeutic response decreased 29.87 9.87 480 407397 51708 64039147
Graft versus host disease 29.85 9.87 26 407851 13787 64077068
Thrombotic microangiopathy 29.62 9.87 37 407840 16618 64074237
Skin papilloma 29.53 9.87 86 407791 5117 64085738
Eosinophilia 29.45 9.87 132 407745 37944 64052911
Tachypnoea 29.42 9.87 79 407798 26492 64064363
No adverse event 29.35 9.87 88 407789 28473 64062382
Drug ineffective for unapproved indication 29.15 9.87 100 407777 31033 64059822
Psychomotor hyperactivity 29.10 9.87 29 407848 14422 64076433
Drug hypersensitivity 28.97 9.87 1219 406658 236596 63854259
Skin cancer 28.95 9.87 151 407726 11823 64079032
Pancytopenia 28.84 9.87 1144 406733 142165 63948690
Injection site warmth 28.67 9.87 164 407713 13298 64077557
Foot fracture 28.66 9.87 205 407672 17952 64072903
Miosis 28.63 9.87 25 407852 13241 64077614
Subdural haematoma 28.43 9.87 87 407790 27967 64062888
Haemoglobin decreased 28.38 9.87 1507 406370 193556 63897299
Brain oedema 28.10 9.87 61 407816 22014 64068841
Tumour lysis syndrome 27.96 9.87 50 407827 19390 64071465
Surgery 27.86 9.87 287 407590 27926 64062929
Forced expiratory volume decreased 27.62 9.87 5 407872 6862 64083993
Joint noise 27.51 9.87 62 407815 3149 64087706
Osteonecrosis of jaw 27.36 9.87 144 407733 39681 64051174
Acute respiratory failure 27.28 9.87 194 407683 49740 64041115
Hypermethioninaemia 27.27 9.87 10 407867 29 64090826
Haemorrhage 27.20 9.87 346 407531 79005 64011850
Blood creatinine increased 27.20 9.87 652 407225 135130 63955725
Foetal death 27.18 9.87 91 407786 5839 64085016
Loss of consciousness 27.15 9.87 722 407155 147643 63943212
Synovial fluid analysis 27.10 9.87 41 407836 1528 64089327
Unintentional medical device removal 26.88 9.87 5 407872 6729 64084126
Rhinorrhoea 26.67 9.87 530 407347 59439 64031416
Vision blurred 26.61 9.87 406 407471 89910 64000945
Vomiting 26.37 9.87 3067 404810 548050 63542805
Malignant melanoma 26.35 9.87 156 407721 12808 64078047
Stevens-Johnson syndrome 26.33 9.87 119 407758 34130 64056725
Fear 26.30 9.87 55 407822 20116 64070739
Proteinuria 25.99 9.87 89 407788 27634 64063221
Blood alkaline phosphatase increased 25.95 9.87 229 407648 56050 64034805
Haemorrhage intracranial 25.70 9.87 72 407805 23812 64067043
Respiratory disorder 25.70 9.87 129 407748 35982 64054873
Loose body in joint 25.69 9.87 35 407842 1183 64089672
Blood parathyroid hormone decreased 25.32 9.87 103 407774 7263 64083592
Cerebrovascular accident 25.31 9.87 669 407208 136914 63953941
Drug use disorder 25.25 9.87 4 407873 6050 64084805
Shock haemorrhagic 25.23 9.87 42 407835 16749 64074106
Maternal exposure timing unspecified 25.16 9.87 54 407823 2653 64088202
Acute chest syndrome 25.13 9.87 30 407847 886 64089969
Acute respiratory distress syndrome 24.99 9.87 144 407733 38791 64052064
Inappropriate antidiuretic hormone secretion 24.88 9.87 66 407811 22223 64068632
Erythema multiforme 24.80 9.87 38 407839 15663 64075192
BK virus infection 24.73 9.87 8 407869 7404 64083451
Creatinine renal clearance decreased 24.66 9.87 33 407844 14388 64076467
Febrile bone marrow aplasia 24.55 9.87 21 407856 11234 64079621
Polyhydramnios 24.47 9.87 38 407839 1449 64089406
Cyanosis 24.43 9.87 66 407811 22089 64068766
Chronic kidney disease 24.41 9.87 241 407636 57678 64033177
Seizure 24.40 9.87 837 407040 166055 63924800
Mobility decreased 24.29 9.87 713 407164 85127 64005728
Hyperthermia 24.21 9.87 38 407839 15512 64075343
Acute generalised exanthematous pustulosis 24.21 9.87 32 407845 14026 64076829
Pleural effusion 24.18 9.87 612 407265 125947 63964908
Wrong technique in product usage process 23.90 9.87 279 407598 64695 64026160
Weight decreased 23.90 9.87 2108 405769 283631 63807224
Fracture delayed union 23.74 9.87 44 407833 1941 64088914
Ulcer 23.73 9.87 236 407641 22754 64068101
Acute graft versus host disease in skin 23.59 9.87 7 407870 6848 64084007
Dry eye 23.55 9.87 284 407593 28735 64062120
Dysarthria 23.47 9.87 251 407626 59155 64031700
Cyst 23.35 9.87 143 407734 11884 64078971
Psychotic disorder 23.22 9.87 126 407751 34452 64056403
Stress cardiomyopathy 23.12 9.87 15 407862 9242 64081613
Leukocytosis 22.94 9.87 142 407735 37598 64053257
Pemphigoid 22.94 9.87 29 407848 12957 64077898
Face oedema 22.87 9.87 80 407797 24681 64066174
Depression 22.85 9.87 937 406940 182354 63908501
Exostosis 22.84 9.87 137 407740 11301 64079554
Postoperative wound infection 22.73 9.87 127 407750 10209 64080646
Pulmonary alveolar haemorrhage 22.70 9.87 17 407860 9721 64081134
Post procedural infection 22.50 9.87 120 407757 9477 64081378
Mania 22.44 9.87 43 407834 16243 64074612
Pharyngitis streptococcal 22.14 9.87 111 407766 8557 64082298
Potentiating drug interaction 22.08 9.87 11 407866 7841 64083014
Acute myeloid leukaemia 21.98 9.87 94 407783 27369 64063486
Nausea 21.97 9.87 4512 403365 781288 63309567
Antinuclear antibody positive 21.97 9.87 88 407789 6162 64084693
Angina pectoris 21.87 9.87 181 407696 44900 64045955
Aphasia 21.83 9.87 160 407717 40746 64050109
Cardiac failure acute 21.79 9.87 44 407833 16300 64074555
Device use error 21.56 9.87 7 407870 6464 64084391
Stillbirth 21.54 9.87 61 407816 3572 64087283
Gamma-glutamyltransferase increased 21.23 9.87 200 407677 48310 64042545
Dyspnoea exertional 21.19 9.87 333 407544 73397 64017458
Dysgeusia 21.00 9.87 193 407684 46854 64044001
Hyperammonaemia 20.97 9.87 19 407858 9885 64080970
Granuloma skin 20.93 9.87 85 407792 5989 64084866
Muscle spasms 20.90 9.87 706 407171 140317 63950538
Joint dislocation 20.81 9.87 134 407743 11331 64079524
Scleritis 20.81 9.87 53 407824 2913 64087942
Panniculitis 20.80 9.87 111 407766 8768 64082087
Labelled drug-drug interaction medication error 20.56 9.87 71 407806 21991 64068864
Chronic graft versus host disease 20.54 9.87 7 407870 6269 64084586
Keratopathy 20.51 9.87 25 407852 755 64090100
Normal newborn 20.48 9.87 80 407797 5537 64085318
Incorrect route of product administration 20.37 9.87 77 407800 23221 64067634
Red blood cell count decreased 20.31 9.87 424 407453 47962 64042893
Haemoptysis 20.29 9.87 205 407672 48843 64042012
Nocardiosis 20.22 9.87 3 407874 4764 64086091
Klebsiella infection 20.16 9.87 33 407844 13248 64077607
Pain in jaw 20.06 9.87 163 407714 40592 64050263
Pancreatitis 20.02 9.87 261 407616 59346 64031509
Acute myocardial infarction 20.00 9.87 315 407562 69403 64021452
Deep vein thrombosis 19.99 9.87 509 407368 104673 63986182
Exposure to toxic agent 19.94 9.87 7 407870 6152 64084703
Oxygen saturation decreased 19.82 9.87 848 407029 106328 63984527
Synovial disorder 19.63 9.87 27 407850 921 64089934
Vertigo 19.60 9.87 259 407618 58752 64032103
Progressive multifocal leukoencephalopathy 19.59 9.87 55 407822 18177 64072678
Dactylitis 19.57 9.87 40 407837 1898 64088957
Clostridium difficile colitis 19.51 9.87 97 407780 27126 64063729
Hallucination, visual 19.48 9.87 100 407777 27734 64063121
Breast feeding 19.41 9.87 23 407854 674 64090181
Cytomegalovirus viraemia 19.32 9.87 24 407853 10804 64080051
Chest discomfort 19.19 9.87 573 407304 115533 63975322
Adenovirus infection 19.17 9.87 11 407866 7244 64083611
Bursitis 19.10 9.87 214 407663 21271 64069584
International normalised ratio increased 19.08 9.87 369 407508 78798 64012057
Respiration abnormal 19.07 9.87 8 407869 6307 64084548
Anhedonia 19.05 9.87 36 407841 13670 64077185
Endodontic procedure 18.96 9.87 44 407833 2279 64088576
Adverse event 18.92 9.87 353 407524 39136 64051719
Induced labour 18.90 9.87 25 407852 821 64090034
Diabetes insipidus 18.83 9.87 3 407874 4518 64086337
Gastroenteritis 18.81 9.87 278 407599 29433 64061422
Bronchospasm 18.74 9.87 72 407805 21610 64069245
Haemorrhage in pregnancy 18.72 9.87 31 407846 1249 64089606
Nightmare 18.61 9.87 69 407808 20924 64069931
Interstitial lung disease 18.56 9.87 473 407404 97259 63993596
Flushing 18.53 9.87 368 407509 78280 64012575
Appendicitis 18.49 9.87 148 407729 13421 64077434
Blood bilirubin increased 18.25 9.87 255 407622 57298 64033557
Metastases to bone 18.22 9.87 67 407810 20368 64070487
Glycosylated haemoglobin increased 18.21 9.87 47 407830 15972 64074883
Acidosis 18.16 9.87 55 407822 17740 64073115
Delusion 18.15 9.87 56 407821 17958 64072897
Muscle spasticity 18.12 9.87 50 407827 16619 64074236
Dermatitis acneiform 18.11 9.87 16 407861 8427 64082428
Electrocardiogram QRS complex prolonged 18.11 9.87 19 407858 9225 64081630
Epstein-Barr virus infection 18.07 9.87 32 407845 12456 64078399
Dystonia 18.07 9.87 60 407817 18805 64072050
Upper respiratory tract infection 18.06 9.87 595 407282 72190 64018665
Status epilepticus 18.05 9.87 73 407804 21590 64069265
Haematoma 18.04 9.87 196 407681 46054 64044801
Lupus-like syndrome 18.01 9.87 106 407771 8685 64082170
Chest pain 18.00 9.87 1267 406610 234713 63856142
Foetal distress syndrome 17.98 9.87 18 407859 434 64090421
Abortion missed 17.98 9.87 29 407848 1143 64089712
Metastases to liver 17.92 9.87 84 407793 23857 64066998
Cytopenia 17.89 9.87 45 407832 15426 64075429
Pyrexia 17.86 9.87 3185 404692 555459 63535396
Spinal disorder 17.76 9.87 105 407772 8617 64082238
Human antichimeric antibody positive 17.71 9.87 32 407845 1384 64089471
Anuria 17.69 9.87 61 407816 18903 64071952
Toxic epidermal necrolysis 17.68 9.87 150 407727 37016 64053839
Haemophagocytic lymphohistiocytosis 17.56 9.87 55 407822 17554 64073301
Injection site urticaria 17.51 9.87 126 407751 11055 64079800
Frequent bowel movements 17.50 9.87 185 407692 18120 64072735
Acute coronary syndrome 17.42 9.87 63 407814 19247 64071608
Tubulointerstitial nephritis 17.42 9.87 119 407758 30790 64060065
Gastric haemorrhage 17.37 9.87 37 407840 13444 64077411
Pancreatitis acute 17.36 9.87 180 407697 42675 64048180
Tooth abscess 17.34 9.87 148 407729 13678 64077177
Hypomagnesaemia 17.26 9.87 152 407725 37224 64053631
Ingrown hair 17.26 9.87 20 407857 572 64090283
Compartment syndrome 17.20 9.87 3 407874 4229 64086626
Device difficult to use 17.18 9.87 22 407855 9776 64081079
Bone density abnormal 17.17 9.87 47 407830 2698 64088157
Eye infection 17.17 9.87 109 407768 9172 64081683
Pulmonary congestion 17.17 9.87 85 407792 23795 64067060
Oliguria 17.17 9.87 42 407835 14534 64076321
Cystitis haemorrhagic 17.16 9.87 15 407862 7941 64082914
Vitamin B6 increased 17.00 9.87 6 407871 15 64090840
Obstructive airways disorder 16.97 9.87 82 407795 23103 64067752
Rebound effect 16.96 9.87 5 407872 4912 64085943
Blood pressure decreased 16.96 9.87 415 407462 85784 64005071
Polyuria 16.88 9.87 34 407843 12609 64078246
Placental disorder 16.85 9.87 24 407853 846 64090009
Mass 16.84 9.87 159 407718 15117 64075738
Sexual dysfunction 16.83 9.87 10 407867 6461 64084394
Hallucination, auditory 16.83 9.87 53 407824 16886 64073969
Pneumatosis intestinalis 16.83 9.87 6 407871 5223 64085632
Hyperuricaemia 16.74 9.87 24 407853 10167 64080688
Lacrimal disorder 16.74 9.87 18 407859 473 64090382
Toxic optic neuropathy 16.71 9.87 25 407852 922 64089933
Hyperbilirubinaemia 16.71 9.87 73 407804 21132 64069723
Tonsillitis 16.65 9.87 77 407800 5743 64085112
Cushingoid 16.44 9.87 93 407784 7510 64083345
Metastases to lung 16.44 9.87 46 407831 15218 64075637
Colitis ulcerative 16.40 9.87 220 407657 22808 64068047
Joint lock 16.27 9.87 47 407830 2784 64088071
Hyperprolactinaemia 16.26 9.87 3 407874 4062 64086793
Pleuritic pain 16.19 9.87 97 407780 7999 64082856
Gestational hypertension 16.16 9.87 34 407843 1647 64089208
Cardiomyopathy 16.15 9.87 94 407783 25262 64065593
Cervical incompetence 16.12 9.87 18 407859 494 64090361
Tooth infection 16.11 9.87 152 407725 14449 64076406
Toxic skin eruption 16.05 9.87 65 407812 19219 64071636
Pulmonary haemorrhage 16.05 9.87 37 407840 13072 64077783
Disease recurrence 15.98 9.87 125 407752 31385 64059470
Coronary arterial stent insertion 15.97 9.87 8 407869 5684 64085171
Pulmonary hypertension 15.96 9.87 185 407692 42954 64047901
Tooth disorder 15.95 9.87 214 407663 22188 64068667
Nephropathy toxic 15.90 9.87 57 407820 17457 64073398
Lipase increased 15.81 9.87 43 407834 14359 64076496
Cellulitis 15.77 9.87 734 407143 92923 63997932
Arthropod bite 15.73 9.87 84 407793 6637 64084218
Arthritis bacterial 15.72 9.87 94 407783 7745 64083110
Jaundice 15.72 9.87 214 407663 48298 64042557
Urinary retention 15.60 9.87 218 407659 48983 64041872
Pulseless electrical activity 15.56 9.87 36 407841 12703 64078152
Toothache 15.56 9.87 174 407703 17285 64073570
Body height below normal 15.46 9.87 35 407842 1783 64089072
White blood cell count decreased 15.44 9.87 828 407049 157009 63933846
Hypophosphataemia 15.38 9.87 45 407832 14675 64076180
Placental insufficiency 15.32 9.87 25 407852 995 64089860
Hyperthyroidism 15.31 9.87 61 407816 18118 64072737
Osteopenia 15.30 9.87 158 407719 15382 64075473
Musculoskeletal disorder 15.30 9.87 177 407700 17729 64073126
Dislocation of vertebra 15.27 9.87 49 407828 3075 64087780
Haematocrit decreased 15.19 9.87 453 407424 54202 64036653
Maternal exposure during breast feeding 15.17 9.87 37 407840 1979 64088876
Cardiac failure chronic 15.14 9.87 21 407856 9020 64081835
Atrioventricular block complete 15.12 9.87 44 407833 14374 64076481
Immunosuppression 15.08 9.87 118 407759 10628 64080227
Drug abuser 15.07 9.87 9 407868 5799 64085056
Dysphagia 15.07 9.87 538 407339 106274 63984581
Wound infection 15.06 9.87 152 407725 14712 64076143
Temperature regulation disorder 15.05 9.87 4 407873 4207 64086648
Breast abscess 15.01 9.87 26 407851 1087 64089768
Heart rate irregular 14.89 9.87 250 407627 27163 64063692
Hypercapnia 14.86 9.87 16 407861 7678 64083177
Hyperlactacidaemia 14.85 9.87 6 407871 4838 64086017
Lymphatic fistula 14.82 9.87 21 407856 737 64090118
Stress 14.80 9.87 494 407383 60040 64030815
Presyncope 14.79 9.87 146 407731 34943 64055912
Femoral hernia incarcerated 14.75 9.87 21 407856 740 64090115
Blood lactic acid increased 14.74 9.87 27 407850 10374 64080481
Wound infection pseudomonas 14.73 9.87 31 407846 1502 64089353
Tardive dyskinesia 14.70 9.87 22 407855 9156 64081699
Drug screen positive 14.70 9.87 9 407868 5720 64085135
Lip swelling 14.63 9.87 130 407747 31777 64059078
Sinus bradycardia 14.51 9.87 85 407792 22808 64068047
Respiratory acidosis 14.49 9.87 25 407852 9830 64081025
Muscle rigidity 14.48 9.87 59 407818 17414 64073441
Finger deformity 14.38 9.87 68 407809 5118 64085737
Graft versus host disease in skin 14.28 9.87 8 407869 5339 64085516
Septic shock 14.22 9.87 534 407343 104903 63985952
Platelet count decreased 14.20 9.87 892 406985 166819 63924036
Polyneuropathy 14.19 9.87 71 407806 19823 64071032
Hypervitaminosis 14.19 9.87 6 407871 28 64090827
Palpitations 14.13 9.87 529 407348 103959 63986896
Muscle twitching 14.02 9.87 67 407810 18931 64071924
Iodine allergy 14.01 9.87 17 407860 511 64090344
Right ventricular failure 14.00 9.87 79 407798 21392 64069463
Tuberculin test positive 13.99 9.87 47 407830 3021 64087834
Bone pain 13.96 9.87 214 407663 47358 64043497
Hemiparesis 13.91 9.87 121 407756 29706 64061149
Delivery 13.88 9.87 17 407860 516 64090339
Ventricular fibrillation 13.88 9.87 91 407786 23769 64067086
Malignant mediastinal neoplasm 13.85 9.87 17 407860 517 64090338
Hypertransaminasaemia 13.84 9.87 15 407862 7176 64083679
Abortion threatened 13.83 9.87 15 407862 398 64090457
Intestinal ischaemia 13.82 9.87 33 407844 11516 64079339
Peritoneal dialysis complication 13.79 9.87 38 407839 2190 64088665
Sickle cell anaemia 13.77 9.87 18 407859 584 64090271
Injection site extravasation 13.76 9.87 93 407784 7993 64082862
Colitis microscopic 13.76 9.87 16 407861 7416 64083439
Cytomegalovirus chorioretinitis 13.63 9.87 7 407870 4905 64085950
Cystitis 13.62 9.87 360 407517 42315 64048540
Pharyngitis 13.61 9.87 182 407695 18857 64071998
Knee operation 13.56 9.87 61 407816 4496 64086359
Product prescribing error 13.54 9.87 150 407727 35119 64055736
Catatonia 13.48 9.87 17 407860 7603 64083252
Hypervolaemia 13.47 9.87 166 407711 38119 64052736
Oedema 13.44 9.87 461 407416 91474 63999381
Cardiotoxicity 13.40 9.87 28 407849 10246 64080609
Bradypnoea 13.38 9.87 8 407869 5151 64085704
Hemiplegia 13.36 9.87 39 407838 12729 64078126
Adjustment disorder with depressed mood 13.36 9.87 40 407837 2417 64088438
Alcohol abuse 13.34 9.87 7 407870 4845 64086010
Ankle arthroplasty 13.33 9.87 22 407855 884 64089971
Clear cell renal cell carcinoma 13.33 9.87 37 407840 2142 64088713
Nephrolithiasis 13.23 9.87 366 407511 43317 64047538
Paralysis 13.20 9.87 34 407843 11561 64079294
Rheumatoid lung 13.15 9.87 40 407837 2439 64088416
Sinus tachycardia 13.12 9.87 135 407742 32053 64058802
Dyslipidaemia 13.09 9.87 24 407853 9218 64081637
Small for dates baby 13.08 9.87 15 407862 424 64090431
Cholestasis of pregnancy 12.99 9.87 22 407855 903 64089952
Sciatica 12.98 9.87 190 407687 20074 64070781
Type 2 diabetes mellitus 12.96 9.87 294 407583 33726 64057129
Virologic failure 12.95 9.87 3 407874 3463 64087392
Kidney infection 12.95 9.87 171 407706 17667 64073188
Hepatic encephalopathy 12.94 9.87 79 407798 20987 64069868
Antibody test positive 12.92 9.87 39 407838 2368 64088487
Erectile dysfunction 12.91 9.87 39 407838 12588 64078267
Transplant dysfunction 12.90 9.87 14 407863 6694 64084161
Pancreatic steatosis 12.89 9.87 23 407854 985 64089870
Joint warmth 12.88 9.87 28 407849 1388 64089467
Palindromic rheumatism 12.87 9.87 13 407864 317 64090538
Myocardial ischaemia 12.86 9.87 90 407787 23161 64067694
Human anti-human antibody test 12.84 9.87 14 407863 374 64090481
Eosinophil count increased 12.76 9.87 46 407831 14066 64076789
Tendon disorder 12.74 9.87 76 407801 6256 64084599
Coordination abnormal 12.74 9.87 50 407827 14914 64075941
Hospitalisation 12.72 9.87 370 407507 74837 64016018
Cataract 12.70 9.87 419 407458 50843 64040012
Injection site haemorrhage 12.68 9.87 220 407657 24058 64066797
Myopathy 12.67 9.87 63 407814 17617 64073238
Pseudomonas infection 12.66 9.87 64 407813 17819 64073036
Ileus 12.65 9.87 89 407788 22877 64067978
Pleural fibrosis 12.65 9.87 55 407822 3995 64086860
Accessory spleen 12.63 9.87 10 407867 175 64090680
Hepatic cyst 12.61 9.87 66 407811 5174 64085681
Hypoxic-ischaemic encephalopathy 12.60 9.87 16 407861 7136 64083719
Oesophageal fibrosis 12.58 9.87 10 407867 176 64090679
Hepatic cytolysis 12.57 9.87 46 407831 14003 64076852
Diabetes mellitus inadequate control 12.56 9.87 81 407796 21240 64069615
Aspartate aminotransferase increased 12.55 9.87 624 407253 119164 63971691
Polydipsia 12.53 9.87 11 407866 5810 64085045
Schizophrenia 12.52 9.87 33 407844 11135 64079720
Sinus congestion 12.48 9.87 151 407726 15288 64075567
Myofascial pain syndrome 12.48 9.87 32 407845 1766 64089089
Postpartum haemorrhage 12.47 9.87 28 407849 1419 64089436
Accidental death 12.46 9.87 4 407873 3721 64087134
Paranoia 12.46 9.87 57 407820 16295 64074560
Mean cell volume increased 12.45 9.87 64 407813 4982 64085873
Genital haemorrhage 12.42 9.87 10 407867 5512 64085343
Skin necrosis 12.41 9.87 142 407735 14187 64076668
Generalised oedema 12.40 9.87 79 407798 20774 64070081
Enterocolitis 12.37 9.87 37 407840 11981 64078874
Dyskinesia 12.31 9.87 175 407702 39213 64051642
Injection site discolouration 12.26 9.87 80 407797 6795 64084060
Visual acuity reduced 12.26 9.87 111 407766 27030 64063825
Drug specific antibody 12.25 9.87 35 407842 2060 64088795
Insomnia 12.16 9.87 1081 406796 196755 63894100
Osteoporotic fracture 12.12 9.87 50 407827 3548 64087307
Blood loss anaemia 12.09 9.87 46 407831 13846 64077009
Myocarditis 12.06 9.87 61 407816 16982 64073873
C-reactive protein decreased 12.03 9.87 35 407842 2081 64088774
Heparin-induced thrombocytopenia 12.02 9.87 22 407855 8457 64082398
Haematemesis 11.96 9.87 217 407660 46782 64044073
Stress at work 11.93 9.87 22 407855 967 64089888
Spinal osteoarthritis 11.92 9.87 141 407736 14200 64076655
Foetal exposure during pregnancy 11.92 9.87 58 407819 4418 64086437
Intestinal stenosis 11.90 9.87 46 407831 3168 64087687
Serum ferritin increased 11.89 9.87 93 407784 8375 64082480
Blood folate increased 11.88 9.87 15 407862 470 64090385
Aplasia 11.80 9.87 16 407861 6937 64083918
Bacteraemia 11.75 9.87 111 407766 26800 64064055
Hepatocellular carcinoma 11.74 9.87 22 407855 8381 64082474
Sepsis 11.73 9.87 1276 406601 229065 63861790
COVID-19 pneumonia 11.72 9.87 59 407818 16445 64074410
Endophthalmitis 11.71 9.87 10 407867 5355 64085500
Ventricular arrhythmia 11.66 9.87 18 407859 7397 64083458
Skin ulcer haemorrhage 11.66 9.87 15 407862 479 64090376
Renal injury 11.63 9.87 54 407823 15375 64075480
Increased tendency to bruise 11.57 9.87 99 407778 9156 64081699
Threatened labour 11.56 9.87 16 407861 549 64090306
Lip blister 11.56 9.87 36 407841 2223 64088632
Renal tubular necrosis 11.55 9.87 87 407790 22023 64068832
Troponin increased 11.54 9.87 54 407823 15345 64075510
Hypoalbuminaemia 11.54 9.87 65 407812 17609 64073246
Incoherent 11.46 9.87 17 407860 7101 64083754
Ketoacidosis 11.44 9.87 16 407861 6847 64084008
Hydrocephalus 11.40 9.87 19 407858 7572 64083283
Retinitis 11.39 9.87 34 407843 2051 64088804
Foot operation 11.36 9.87 55 407822 4180 64086675
Coronary artery bypass 11.34 9.87 12 407865 5803 64085052
Prostatic specific antigen increased 11.32 9.87 24 407853 8736 64082119
Affective disorder 11.31 9.87 15 407862 6565 64084290
Cholangitis 11.30 9.87 33 407844 10769 64080086
Hernia 11.28 9.87 133 407744 13385 64077470
Skin laceration 11.26 9.87 217 407660 24200 64066655
Feeling abnormal 11.24 9.87 711 407166 132891 63957964
Skin fissures 11.22 9.87 107 407770 10199 64080656
Aphthous ulcer 11.22 9.87 128 407749 12778 64078077
Hypotonia 11.20 9.87 35 407842 11177 64079678
Anal fistula 11.19 9.87 64 407813 5189 64085666
Lung transplant 11.19 9.87 6 407871 4102 64086753
Hypertriglyceridaemia 11.17 9.87 35 407842 11170 64079685
Alcohol interaction 11.17 9.87 7 407870 4394 64086461
Blood iron increased 11.15 9.87 26 407851 1351 64089504
Skin neoplasm excision 11.05 9.87 20 407857 866 64089989
Haemodialysis 11.04 9.87 63 407814 17014 64073841
Neuropathy peripheral 11.03 9.87 619 407258 116906 63973949
Sudden death 11.01 9.87 78 407799 20018 64070837
Laryngospasm 11.01 9.87 4 407873 3441 64087414
Accidental exposure to product 10.98 9.87 110 407767 26254 64064601
Atrioventricular block 10.97 9.87 39 407838 11976 64078879
Vacuum extractor delivery 10.97 9.87 8 407869 123 64090732
End stage renal disease 10.96 9.87 32 407845 10443 64080412
Nephrotic syndrome 10.93 9.87 28 407849 9539 64081316
Skin graft failure 10.88 9.87 10 407867 216 64090639
Peripheral venous disease 10.85 9.87 73 407804 6265 64084590
Hypernatraemia 10.84 9.87 40 407837 12149 64078706
Mycobacterium tuberculosis complex test positive 10.83 9.87 33 407844 2014 64088841
Unevaluable event 10.79 9.87 240 407637 50249 64040606
Ankylosing spondylitis 10.78 9.87 89 407788 8145 64082710
Abortion incomplete 10.76 9.87 3 407874 3058 64087797
Mental disorder 10.74 9.87 111 407766 26334 64064521
Mesothelioma 10.73 9.87 12 407865 330 64090525
Chondropathy 10.72 9.87 36 407841 2313 64088542
Glomerular filtration rate decreased 10.71 9.87 76 407801 19496 64071359
Oxygen consumption increased 10.68 9.87 8 407869 4573 64086282
Radiation inflammation 10.66 9.87 10 407867 222 64090633
Swollen joint count 10.66 9.87 16 407861 592 64090263
Lower respiratory tract congestion 10.65 9.87 42 407835 2919 64087936
Brain natriuretic peptide increased 10.65 9.87 20 407857 7613 64083242
Catheter site erythema 10.63 9.87 9 407868 4840 64086015
Hepatitis acute 10.61 9.87 46 407831 13343 64077512
Nail injury 10.60 9.87 14 407863 459 64090396
Hypoglycaemic coma 10.57 9.87 7 407870 4267 64086588
Medical device site joint infection 10.55 9.87 10 407867 225 64090630
Cartilage injury 10.53 9.87 25 407852 1314 64089541
Pneumonia bacterial 10.53 9.87 54 407823 14981 64075874
Intervertebral disc degeneration 10.47 9.87 128 407749 12992 64077863
Purpura 10.42 9.87 65 407812 17181 64073674
Twin pregnancy 10.41 9.87 19 407858 828 64090027
Pancreatic duct stenosis 10.41 9.87 10 407867 229 64090626
Renal disorder 10.41 9.87 159 407718 35206 64055649
Device leakage 10.39 9.87 23 407854 8243 64082612
Failed induction of labour 10.30 9.87 10 407867 232 64090623
Benign ovarian tumour 10.29 9.87 11 407866 287 64090568
Tooth fracture 10.29 9.87 102 407775 9825 64081030
Uterine perforation 10.28 9.87 13 407864 5807 64085048
Capillary leak syndrome 10.25 9.87 4 407873 3293 64087562
Memory impairment 10.25 9.87 440 407437 85242 64005613
Acute graft versus host disease in intestine 10.23 9.87 5 407872 3604 64087251
Speech disorder developmental 10.22 9.87 15 407862 544 64090311
Dermatitis allergic 10.21 9.87 143 407734 14966 64075889
Oligohydramnios 10.20 9.87 43 407834 3081 64087774
Complication of device insertion 10.16 9.87 10 407867 5002 64085853
Hepatitis cholestatic 10.10 9.87 41 407836 12114 64078741
Anti-neutrophil cytoplasmic antibody positive vasculitis 10.10 9.87 3 407874 2933 64087922
Labyrinthitis 10.09 9.87 38 407839 2585 64088270
Immune thrombocytopenia 10.06 9.87 55 407822 15011 64075844
Hyperhomocysteinaemia 10.04 9.87 13 407864 418 64090437
Vascular insufficiency 9.99 9.87 14 407863 486 64090369
Decreased insulin requirement 9.96 9.87 8 407869 143 64090712
Hypocalcaemia 9.94 9.87 195 407682 41558 64049297
Personality change 9.93 9.87 25 407852 8568 64082287
Neck pain 9.88 9.87 480 407397 61053 64029802

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11HA02 ALIMENTARY TRACT AND METABOLISM
VITAMINS
OTHER PLAIN VITAMIN PREPARATIONS
Other plain vitamin preparations
ATC J04AM08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOBACTERIALS
DRUGS FOR TREATMENT OF TUBERCULOSIS
Combinations of drugs for treatment of tuberculosis
FDA Chemical/Ingredient N0000005657 Vitamin B 6
FDA Chemical/Ingredient N0000175452 Analogs/Derivatives
MeSH PA D018977 Micronutrients
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
FDA EPC N0000192800 Vitamin B6 Analog
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:75772 S. cerevisiae metabolites
CHEBI has role CHEBI:76971 Escherichia coli metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pregnancy, function indication 289908002
Vitamin B6 deficiency indication 386080007 DOID:8455
Breastfeeding (mother) indication 413712001
Drug-Induced Pyridoxine Deficiency indication
Pyridoxine-Dependent Seizure indication
Nutritional disorder contraindication 2492009 DOID:374
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Gastroenteritis contraindication 25374005 DOID:2326
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hemosiderosis contraindication 39011001 DOID:12119
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Gastrectomy contraindication 53442002
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Schizophrenia contraindication 58214004 DOID:5419
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Hemolytic anemia contraindication 61261009 DOID:583
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by acetaminophen contraindication 70273001
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Atrophic gastritis contraindication 84568007 DOID:8929
Autoimmune disease contraindication 85828009
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Acute hepatic failure contraindication 197270009
Impaired renal function disorder contraindication 197663003
Gastroparesis contraindication 235675006
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Esophageal dysmotility contraindication 266434009 DOID:9192
Diabetic - poor control contraindication 268519009
Peripheral nerve disease contraindication 302226006
Primary adrenocortical insufficiency contraindication 373662000
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Ketoacidosis in diabetes mellitus contraindication 420422005 DOID:1837
Diabetic peripheral neuropathy contraindication 424736006
Slow acetylator due to N-acetyltransferase enzyme variant contraindication 425079005
Chronic Hepatic Disease contraindication
Genitourinary Tract Infections contraindication
Repeated Blood Transfusions contraindication
Prolonged-Severe Nausea and Vomiting contraindication
Esophageal Compression contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.98 acidic
pKa2 13.8 acidic
pKa3 4.94 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9089489 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9375404 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9526703 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9937132 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Serine hydroxymethyltransferase, cytosolic Enzyme WOMBAT-PK
Pyridoxine-5'-phosphate oxidase Enzyme WOMBAT-PK
Pyridoxal phosphate phosphatase Enzyme WOMBAT-PK
Pyridoxal kinase Kinase WOMBAT-PK
Cystathionine beta-synthase Enzyme WOMBAT-PK
Phosphoserine aminotransferase Enzyme WOMBAT-PK

External reference:

IDSource
4019922 VUID
N0000148007 NUI
D02179 KEGG_DRUG
58-56-0 SECONDARY_CAS_RN
4017489 VANDF
4017779 VANDF
4018569 VANDF
4019922 VANDF
4021899 VANDF
C0034272 UMLSCUI
CHEBI:16709 CHEBI
UEG PDB_CHEM_ID
CHEMBL1364 ChEMBL_ID
DB00165 DRUGBANK_ID
CHEMBL1200756 ChEMBL_ID
D011736 MESH_DESCRIPTOR_UI
1054 PUBCHEM_CID
2216 INN_ID
KV2JZ1BI6Z UNII
203164 RXNORM
35074 MMSL
4979 MMSL
4994 MMSL
5393 MMSL
5686 MMSL
6601 MMSL
d00412 MMSL
001058 NDDF
004538 NDDF
126227009 SNOMEDCT_US
430469009 SNOMEDCT_US
767286000 SNOMEDCT_US
D025101 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 10 mg ORAL Unapproved drug other 12 sections
CitraNatal Harmony 3.0 HUMAN PRESCRIPTION DRUG LABEL 8 0178-0796 CAPSULE, GELATIN COATED 25 mg ORAL unapproved drug other 10 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0798 CAPSULE, GELATIN COATED 25 mg ORAL UNAPPROVED DRUG OTHER 11 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0799 CAPSULE, GELATIN COATED 25 mg ORAL Unapproved drug other 11 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0812 CAPSULE, GELATIN COATED 25 mg ORAL Unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 20 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN OTC DRUG LABEL 14 0178-0829 TABLET 20 mg ORAL Unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 13 0178-0858 TABLET 20 mg ORAL Unapproved drug other 12 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 14 0178-0859 TABLET 20 mg ORAL Unapproved drug other 9 sections
CitraNatal Medley HUMAN PRESCRIPTION DRUG LABEL 8 0178-0896 CAPSULE, GELATIN COATED 12.50 mg ORAL unapproved drug other 10 sections
CitraNatal DHA HUMAN OTC DRUG LABEL 14 0178-0898 TABLET 20 mg ORAL Unapproved drug other 11 sections
Doxylamine Succinate and Pyridoxine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-4615 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 26 sections
Doxylamine succinate and pyridoxine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0591-2132 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 25 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 2.50 mg ORAL unapproved drug other 14 sections
Vitafol Caplet HUMAN PRESCRIPTION DRUG LABEL 12 0642-0072 CAPSULE 15 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 2.50 mg ORAL Unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Strovite Forte Caplet HUMAN PRESCRIPTION DRUG LABEL 19 0642-0204 TABLET, COATED 25 mg ORAL UNAPPROVED DRUG OTHER 15 sections
Strovite One Caplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 25 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Reaphirm Plant Source DHA HUMAN PRESCRIPTION DRUG LABEL 16 0642-3010 CAPSULE, GELATIN COATED 2.50 mg ORAL unapproved drug other 7 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 4 0642-7468 STRIP 2.50 mg ORAL Unapproved drug other 13 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Marnatal F HUMAN PRESCRIPTION DRUG LABEL 13 0682-1570 CAPSULE 5 mg ORAL UNAPPROVED DRUG OTHER 4 sections
BACMIN HUMAN PRESCRIPTION DRUG LABEL 19 0682-3001 TABLET, COATED 25 mg ORAL UNAPPROVED DRUG OTHER 10 sections
O-Cal Prenatal Vitamin HUMAN PRESCRIPTION DRUG LABEL 16 0813-0202 TABLET 12 mg ORAL UNAPPROVED DRUG OTHER 6 sections
Dialyvite Supreme D HUMAN PRESCRIPTION DRUG LABEL 13 10542-009 TABLET, COATED 25 mg ORAL Unapproved drug other 7 sections