nicotinamide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
nicotinic acid or nicotinoyl alcohol derivatives 1906 98-92-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • niacinamide
  • nicotinamide
  • 3-pyridinecarboxamide
An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and PELLAGRA. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.
  • Molecular weight: 122.13
  • Formula: C6H6N2O
  • CLOGP: -0.21
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 55.98
  • ALOGS: -0.39
  • ROTB: 1

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.15 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.320 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.968 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 40.179 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 3.556 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 73.450 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 81.640 % High 1
herg hERG pIC50 3.608 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 2.685 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.177 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 66.510 % High 1
kinase-safety-class ACVR2A,ACVR2B,ALK,AURKA,AXL,BRAF,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,ERBB2,FLT3,GRK1,GRK2,GRK3,ITK,JAK1,MAP3K21,MAPK7,MARK4,NTRK2,PDK2,PDK4,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,TEK,TTK,ULK1 36
kinase-selectivity-class ACVR2B,AXL,BRAF,CDK9,DYRK1B,ERBB2,GRK2,PRKDC,SIK2 9
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.247 High 1
mh-clint Mouse hepatocyte intrinsic clearance 1.435 High 1
mppb Mouse plasma protein binding (% unbound) 91.450 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.641 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.65
pppb Pig plasma protein binding (% unbound) 81.910 % High 1
rh-clint Rat hepatocyte intrinsic clearance 0.726 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 94.850 % High 1
rppb Rat plasma protein binding (% unbound) 74.950 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 903.649 uM High 1

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 1953 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 1341.43 10.11 6666 904447 320198 89397136
Systemic lupus erythematosus 1295.24 10.11 7105 904008 354791 89362543
Glossodynia 1146.03 10.11 6310 904803 315469 89401865
Completed suicide 1129.90 10.11 86 911027 144972 89572362
Toxicity to various agents 1033.31 10.11 827 910286 287019 89430315
Hand deformity 932.93 10.11 5625 905488 290737 89426597
Arthropathy 923.98 10.11 6575 904538 359667 89357667
Abdominal discomfort 858.42 10.11 7932 903181 469396 89247938
Alopecia 827.33 10.11 8100 903013 486971 89230363
Wound 764.13 10.11 5440 905673 297540 89419794
Joint swelling 669.69 10.11 7868 903245 495432 89221902
Synovitis 646.07 10.11 5585 905528 324167 89393167
Contraindicated product administered 641.80 10.11 5450 905663 314689 89402645
Intentional overdose 639.93 10.11 91 911022 93743 89623591
Drug interaction 628.40 10.11 1136 909977 275317 89442017
Swelling 621.09 10.11 6692 904421 412366 89304968
Maternal exposure during pregnancy 617.83 10.11 5926 905187 354137 89363197
Anti-cyclic citrullinated peptide antibody positive 616.18 10.11 4280 906833 232153 89485181
Pericarditis 607.90 10.11 4722 906391 265429 89451905
Infusion related reaction 601.21 10.11 6620 904493 410160 89307174
Pain 589.53 10.11 13621 897492 982720 88734614
Death 574.58 10.11 2498 908615 454053 89263281
Rheumatoid arthritis 563.53 10.11 5847 905266 356767 89360567
Discomfort 552.16 10.11 4675 906438 269660 89447674
Febrile neutropenia 469.81 10.11 539 910574 157810 89559524
Duodenal ulcer perforation 469.70 10.11 3817 907296 217471 89499863
Helicobacter infection 442.72 10.11 3840 907273 223010 89494324
Suicide attempt 439.79 10.11 108 911005 75291 89642043
Drug abuse 423.59 10.11 149 910964 82198 89635136
Hepatic enzyme increased 416.53 10.11 5494 905619 355242 89362092
Acute kidney injury 405.76 10.11 1748 909365 318639 89398695
Psoriatic arthropathy 360.98 10.11 3696 907417 224639 89492695
Neutropenia 353.55 10.11 1122 909991 223782 89493552
Rheumatoid factor positive 353.45 10.11 2941 908172 168709 89548625
Cardiac arrest 351.12 10.11 322 910791 104613 89612721
Malignant neoplasm progression 343.50 10.11 340 910773 106530 89610804
Disease progression 337.65 10.11 664 910449 155951 89561383
Product use issue 327.61 10.11 4893 906220 325026 89392308
Electrocardiogram QT prolonged 304.02 10.11 175 910938 72281 89645053
Lactic acidosis 275.98 10.11 82 911031 50381 89666953
Arthralgia 275.81 10.11 9984 901129 768538 88948796
Impaired healing 268.80 10.11 3564 907549 230635 89486699
Therapeutic product effect decreased 268.22 10.11 4098 907015 273473 89443861
Folliculitis 249.28 10.11 3145 907968 201208 89516126
Musculoskeletal stiffness 248.84 10.11 4277 906836 292255 89425079
Nasopharyngitis 235.27 10.11 5553 905560 401551 89315783
Exposure during pregnancy 234.97 10.11 3532 907581 234878 89482456
Cardiac failure 234.44 10.11 466 910647 109030 89608304
Hyponatraemia 233.87 10.11 633 910480 132905 89584429
Depressed level of consciousness 232.22 10.11 233 910880 72551 89644783
Hypersensitivity 229.02 10.11 6088 905025 448589 89268745
Rheumatic fever 228.38 10.11 2450 908663 150671 89566663
Blister 215.71 10.11 3683 907430 251315 89466019
Bradycardia 215.09 10.11 318 910795 83529 89633805
Drug reaction with eosinophilia and systemic symptoms 213.74 10.11 81 911032 42677 89674657
Hypotension 212.51 10.11 2167 908946 323230 89394104
Muscle injury 209.60 10.11 2705 908408 173949 89543385
Fibromyalgia 208.75 10.11 3070 908043 203199 89514135
Irritable bowel syndrome 207.38 10.11 3081 908032 204367 89512967
Renal failure 204.76 10.11 655 910458 130352 89586982
Lower respiratory tract infection 203.27 10.11 3596 907517 247063 89470271
Somnolence 194.48 10.11 1266 909847 207818 89509516
Sleep disorder due to general medical condition, insomnia type 192.28 10.11 2060 909053 126634 89590700
Rhabdomyolysis 190.34 10.11 142 910971 51114 89666220
Drug intolerance 189.09 10.11 5862 905251 441729 89275605
Treatment failure 188.29 10.11 4187 906926 299741 89417593
Nausea 185.53 10.11 9201 901912 1101115 88616219
Serotonin syndrome 184.06 10.11 75 911038 37812 89679522
Swollen joint count increased 183.21 10.11 1816 909297 109390 89607944
Renal impairment 179.16 10.11 507 910606 104914 89612420
Angioedema 178.45 10.11 234 910879 64642 89652692
Myelosuppression 176.24 10.11 167 910946 53424 89663910
Drug ineffective for unapproved indication 174.63 10.11 249 910864 66395 89650939
Type 2 diabetes mellitus 172.73 10.11 2938 908175 200306 89517028
Agitation 172.57 10.11 254 910859 66844 89650490
Sopor 172.51 10.11 22 911091 24622 89692712
Hypoglycaemia 168.57 10.11 276 910837 69572 89647762
Fatigue 165.85 10.11 13604 897509 1140419 88576915
Hip arthroplasty 164.42 10.11 1320 909793 74888 89642446
Respiratory failure 163.58 10.11 624 910489 117794 89599540
Blood cholesterol increased 163.57 10.11 2970 908143 205042 89512292
Ill-defined disorder 162.34 10.11 2687 908426 182204 89535130
Knee arthroplasty 159.91 10.11 1404 909709 81778 89635556
Metabolic acidosis 158.13 10.11 196 910917 55480 89661854
Multiple organ dysfunction syndrome 156.68 10.11 279 910834 68057 89649277
Cardio-respiratory arrest 156.61 10.11 245 910868 62895 89654439
Sinusitis 156.01 10.11 4535 906578 338553 89378781
Syncope 153.31 10.11 748 910365 131915 89585419
Intentional self-injury 150.97 10.11 53 911060 29281 89688053
Anaemia 150.73 10.11 2566 908547 350236 89367098
Tachycardia 150.53 10.11 947 910166 156726 89560608
Coma 147.11 10.11 319 910794 72313 89645021
Overdose 145.57 10.11 957 910156 156752 89560582
Respiratory arrest 144.73 10.11 77 911036 33234 89684100
Hepatic function abnormal 144.45 10.11 151 910962 46137 89671197
C-reactive protein abnormal 140.62 10.11 1926 909187 125503 89591831
Tremor 140.61 10.11 931 910182 152242 89565092
Seizure 138.45 10.11 931 910182 151698 89565636
Contusion 137.75 10.11 3403 907710 247813 89469521
Peripheral swelling 135.65 10.11 5256 905857 407850 89309484
Cytokine release syndrome 134.88 10.11 56 911057 27917 89689417
No adverse event 130.03 10.11 308 910805 67674 89649660
Stomatitis 128.40 10.11 3644 907469 271054 89446280
Red blood cell sedimentation rate abnormal 128.30 10.11 533 910580 23671 89693663
Altered state of consciousness 128.26 10.11 79 911034 31453 89685881
Drug resistance 127.07 10.11 74 911039 30375 89686959
Hyperkalaemia 123.72 10.11 295 910818 64669 89652665
Hepatic failure 122.40 10.11 131 910982 39597 89677737
Osteoarthritis 121.91 10.11 2699 908414 193031 89524303
Liver injury 121.89 10.11 2400 908713 168167 89549167
Hypoxia 120.94 10.11 351 910762 72048 89645286
Hyperglycaemia 120.58 10.11 204 910909 50766 89666568
Sickle cell anaemia with crisis 119.03 10.11 241 910872 7056 89710278
Weight increased 116.63 10.11 5227 905886 412700 89304634
Rash 116.57 10.11 9401 901712 786699 88930635
Device expulsion 114.99 10.11 145 910968 40741 89676593
Sedation 114.69 10.11 192 910921 47979 89669355
Hepatocellular injury 114.43 10.11 75 911038 28883 89688451
Encephalopathy 113.49 10.11 182 910931 46262 89671072
Intentional product use issue 111.49 10.11 2913 908200 213979 89503355
Immunodeficiency 111.41 10.11 781 910332 42453 89674881
Thrombocytopenia 109.02 10.11 1460 909653 207265 89510069
Bursitis 108.85 10.11 1895 909218 129759 89587575
Suicidal ideation 108.02 10.11 380 910733 73475 89643859
Shock 107.79 10.11 79 911034 28699 89688635
Metastases to bone 106.41 10.11 62 911051 25443 89691891
Anaphylactic shock 105.75 10.11 97 911016 31520 89685814
Sepsis 104.29 10.11 1230 909883 178584 89538750
Anaphylactic reaction 103.72 10.11 489 910624 87035 89630299
Cytomegalovirus infection 103.63 10.11 70 911043 26532 89690802
Ventricular tachycardia 103.18 10.11 60 911053 24648 89692686
Cholestasis 102.85 10.11 128 910985 36171 89681163
Neuropathy peripheral 100.01 10.11 887 910226 136083 89581251
Off label use 99.65 10.11 9637 901476 1092615 88624719
Hypokalaemia 99.33 10.11 841 910272 130275 89587059
Injury 98.68 10.11 2641 908472 194708 89522626
Neoplasm progression 98.09 10.11 186 910927 44300 89673034
Myalgia 97.72 10.11 1208 909905 173917 89543417
Psoriasis 96.31 10.11 2051 909062 145703 89571631
Neutrophil count decreased 96.17 10.11 381 910732 71151 89646183
Chest discomfort 95.42 10.11 909 910204 137456 89579878
Dehydration 95.17 10.11 1378 909735 193069 89524265
Hallucination 94.72 10.11 342 910771 65617 89651717
Joint range of motion decreased 94.68 10.11 1902 909211 133741 89583593
Drug dependence 94.55 10.11 93 911020 29234 89688100
Leukopenia 94.49 10.11 608 910505 100102 89617232
Palpitations 94.39 10.11 898 910215 135830 89581504
Dyspnoea 93.93 10.11 7604 903509 873351 88843983
Dysarthria 93.30 10.11 261 910852 54221 89663113
Diarrhoea 92.17 10.11 8160 902953 931030 88786304
Pregnancy 90.68 10.11 989 910124 61058 89656276
Dysphagia 90.16 10.11 709 910404 111569 89605765
Mobility decreased 90.11 10.11 3223 907890 247511 89469823
Schizophrenia 89.66 10.11 20 911093 14894 89702440
Infection 89.52 10.11 4475 906638 357619 89359715
Facet joint syndrome 89.32 10.11 1438 909675 96951 89620383
Palmar-plantar erythrodysaesthesia syndrome 89.04 10.11 90 911023 27933 89689401
Drug withdrawal syndrome 88.17 10.11 95 911018 28628 89688706
Inflammation 87.85 10.11 2385 908728 176207 89541127
Ejection fraction decreased 87.27 10.11 81 911032 26172 89691162
Vomiting 85.39 10.11 6795 904318 781498 88935836
Cognitive disorder 85.08 10.11 383 910730 69024 89648310
Mydriasis 84.66 10.11 23 911090 14989 89702345
Metastases to liver 84.36 10.11 99 911014 28708 89688626
Grip strength decreased 84.02 10.11 1353 909760 91223 89626111
Diabetic ketoacidosis 83.89 10.11 73 911040 24334 89693000
Cardiac failure congestive 83.12 10.11 615 910498 98079 89619255
Torsade de pointes 82.41 10.11 25 911088 15157 89702177
Drug level increased 81.74 10.11 95 911018 27667 89689667
Blood pressure diastolic abnormal 81.62 10.11 406 910707 19475 89697859
Blood creatinine increased 81.51 10.11 640 910473 100746 89616588
Myocardial infarction 81.50 10.11 677 910436 105295 89612039
Disorientation 81.10 10.11 204 910909 43910 89673424
Blood glucose increased 80.46 10.11 593 910520 94653 89622681
Prescribed overdose 80.25 10.11 1404 909709 96221 89621113
Lip dry 80.18 10.11 1444 909669 99511 89617823
Accidental exposure to product 80.18 10.11 193 910920 42173 89675161
Poisoning 79.16 10.11 27 911086 15190 89702144
Constipation 79.07 10.11 2179 908934 278216 89439118
Parkinsonism 78.48 10.11 22 911091 14043 89703291
Loss of consciousness 78.36 10.11 967 910146 139271 89578063
Blood pressure systolic abnormal 78.01 10.11 395 910718 19083 89698251
Neurotoxicity 77.75 10.11 61 911052 21406 89695928
Gamma-glutamyltransferase increased 77.42 10.11 166 910947 37786 89679548
Live birth 77.05 10.11 1170 909943 77937 89639397
Acute hepatic failure 76.91 10.11 68 911045 22493 89694841
Pulmonary embolism 75.78 10.11 895 910218 129925 89587409
Ascites 75.75 10.11 237 910876 47503 89669831
Blood bilirubin increased 75.36 10.11 207 910906 43263 89674071
Thrombotic microangiopathy 75.12 10.11 32 911081 15711 89701623
Osteonecrosis of jaw 74.90 10.11 177 910936 38926 89678408
Unresponsive to stimuli 74.27 10.11 171 910942 37950 89679384
Hypothermia 73.78 10.11 32 911081 15543 89701791
Wrong technique in product usage process 72.40 10.11 422 910691 71149 89646185
Disseminated intravascular coagulation 72.13 10.11 66 911047 21472 89695862
Extrapyramidal disorder 71.84 10.11 37 911076 16266 89701068
Posterior reversible encephalopathy syndrome 71.83 10.11 71 911042 22268 89695066
Cerebral haemorrhage 71.25 10.11 150 910963 34372 89682962
Disturbance in attention 71.18 10.11 239 910874 46870 89670464
Drug use disorder 70.89 10.11 3 911110 8340 89708994
Anxiety 70.61 10.11 2476 908637 307296 89410038
Psychotic disorder 70.24 10.11 129 910984 31101 89686233
Aspartate aminotransferase increased 70.22 10.11 678 910435 102259 89615075
Blood creatine phosphokinase increased 70.08 10.11 148 910965 33875 89683459
Obesity 69.20 10.11 1466 909647 104041 89613293
Disability assessment scale score increased 69.15 10.11 134 910979 3797 89713537
Therapy partial responder 68.67 10.11 72 911041 21971 89695363
Respiratory depression 67.67 10.11 36 911077 15539 89701795
Inappropriate antidiuretic hormone secretion 67.45 10.11 58 911055 19447 89697887
Deep vein thrombosis postoperative 65.80 10.11 1039 910074 69770 89647564
Device difficult to use 65.78 10.11 48 911065 17477 89699857
Pulmonary fibrosis 65.19 10.11 1477 909636 106026 89611308
Akathisia 65.03 10.11 16 911097 11143 89706191
Alanine aminotransferase increased 64.98 10.11 819 910294 117519 89599815
Blood pressure decreased 64.85 10.11 463 910650 74432 89642902
Exposure to toxic agent 64.11 10.11 4 911109 7963 89709371
Polyneuropathy 63.90 10.11 60 911053 19281 89698053
Toxic skin eruption 63.49 10.11 40 911073 15734 89701600
Pancreatitis acute 63.42 10.11 143 910970 31972 89685362
Night sweats 62.85 10.11 1718 909395 127048 89590286
Swollen tongue 62.26 10.11 244 910869 45712 89671622
Arthritis 62.13 10.11 2159 908954 165156 89552178
Platelet count decreased 62.09 10.11 985 910128 135984 89581350
Stevens-Johnson syndrome 62.02 10.11 126 910987 29250 89688084
Ventricular fibrillation 61.70 10.11 32 911081 14012 89703322
Mental status changes 61.31 10.11 236 910877 44443 89672891
Vision blurred 61.05 10.11 762 910351 109531 89607803
Proteinuria 61.03 10.11 87 911026 23204 89694130
Status epilepticus 60.67 10.11 60 911053 18814 89698520
Haematotoxicity 60.59 10.11 25 911088 12510 89704824
Myoclonus 60.40 10.11 62 911051 19106 89698228
Respiratory distress 59.93 10.11 196 910917 38750 89678584
Hypomagnesaemia 59.82 10.11 172 910941 35416 89681918
Hypomania 59.78 10.11 9 911104 8888 89708446
Eosinophilia 59.71 10.11 123 910990 28410 89688924
Blood pressure fluctuation 59.35 10.11 796 910317 51617 89665717
Restlessness 59.05 10.11 174 910939 35546 89681788
Joint effusion 58.60 10.11 369 910744 19341 89697993
Miosis 58.48 10.11 12 911101 9472 89707862
Product use in unapproved indication 58.35 10.11 2773 908340 333463 89383871
Hepatotoxicity 57.98 10.11 250 910863 45592 89671742
Dyskinesia 57.52 10.11 182 910931 36352 89680982
Post transplant lymphoproliferative disorder 57.42 10.11 3 911110 6946 89710388
Abortion spontaneous 57.16 10.11 811 910302 53245 89664089
Temperature regulation disorder 56.54 10.11 293 910820 14286 89703048
Face oedema 56.38 10.11 92 911021 23226 89694108
Wound infection 56.36 10.11 1435 909678 104967 89612367
Peripheral venous disease 56.31 10.11 1170 909943 82751 89634583
Hyperhidrosis 56.30 10.11 997 910116 135308 89582026
Angina pectoris 56.25 10.11 203 910910 38957 89678377
Chronic kidney disease 56.24 10.11 286 910827 49905 89667429
Acute generalised exanthematous pustulosis 56.20 10.11 34 911079 13669 89703665
Loss of personal independence in daily activities 56.09 10.11 1778 909335 134327 89583007
Dystonia 55.78 10.11 52 911061 16767 89700567
Foot deformity 55.70 10.11 876 910237 58775 89658559
Pulmonary oedema 55.60 10.11 380 910733 61700 89655634
Cardiogenic shock 55.09 10.11 101 911012 24367 89692967
Mucosal inflammation 55.02 10.11 346 910767 57279 89660055
Abnormal behaviour 54.97 10.11 89 911024 22539 89694795
Gastrointestinal disorder 54.71 10.11 3129 907984 253558 89463776
Hepatic cytolysis 54.51 10.11 146 910967 30770 89686564
Withdrawal syndrome 54.34 10.11 89 911024 22435 89694899
Dislocation of vertebra 54.20 10.11 827 910286 55141 89662193
Multiple sclerosis relapse 54.19 10.11 306 910807 51999 89665335
Hemiparesis 54.06 10.11 153 910960 31666 89685668
General physical health deterioration 53.93 10.11 4207 906906 350908 89366426
Musculoskeletal pain 53.54 10.11 2168 908945 169083 89548251
Haemophagocytic lymphohistiocytosis 53.42 10.11 46 911067 15413 89701921
Blood alkaline phosphatase increased 53.28 10.11 275 910838 47804 89669530
Aggression 53.27 10.11 118 910995 26550 89690784
Transplant rejection 53.24 10.11 31 911082 12727 89704607
Arrhythmia 52.84 10.11 232 910881 42100 89675234
Diabetes mellitus inadequate control 52.81 10.11 66 911047 18618 89698716
Sciatica 52.73 10.11 1364 909749 100018 89617316
Cerebrovascular accident 52.49 10.11 899 910214 122634 89594700
Obstructive airways disorder 52.06 10.11 114 910999 25755 89691579
Road traffic accident 51.40 10.11 1432 909681 106194 89611140
Asthenia 51.34 10.11 4643 906470 529108 89188226
Atrial fibrillation 50.92 10.11 991 910122 132620 89584714
Personality disorder 50.86 10.11 31 911082 12413 89704921
Aphasia 50.83 10.11 239 910874 42573 89674761
Disease recurrence 50.32 10.11 201 910912 37452 89679882
Muscle rigidity 50.15 10.11 42 911071 14267 89703067
Metastases to lung 50.08 10.11 52 911061 15939 89701395
Bronchospasm 49.80 10.11 82 911031 20627 89696707
Melaena 49.57 10.11 181 910932 34616 89682718
Flushing 49.49 10.11 610 910503 87881 89629453
Sinus tachycardia 49.26 10.11 136 910977 28377 89688957
Tachypnoea 48.84 10.11 87 911026 21222 89696112
Juvenile idiopathic arthritis 48.61 10.11 117 910996 3860 89713474
Bronchopulmonary aspergillosis 48.56 10.11 27 911086 11371 89705963
Blood pressure systolic increased 48.26 10.11 840 910273 57505 89659829
Pleural effusion 48.23 10.11 813 910300 111178 89606156
Cerebral infarction 48.11 10.11 124 910989 26472 89690862
Autoimmune disorder 47.97 10.11 1059 910054 75685 89641649
Cough 47.81 10.11 3131 907982 365831 89351503
Myocarditis 47.80 10.11 41 911072 13765 89703569
Emotional distress 47.56 10.11 198 910915 36464 89680870
Acute myeloid leukaemia 47.55 10.11 84 911029 20556 89696778
Nasal polyps 47.49 10.11 25 911088 10855 89706479
Condition aggravated 47.22 10.11 6752 904361 588793 89128541
Coeliac disease 47.06 10.11 669 910444 43941 89673393
Dizziness 46.88 10.11 5197 905916 584087 89133247
Hemiplegia 46.82 10.11 56 911057 16104 89701230
Mania 46.45 10.11 44 911069 14080 89703254
Red blood cell sedimentation rate increased 46.44 10.11 1123 909990 81472 89635862
Joint destruction 46.08 10.11 259 910854 13028 89704306
Carpal tunnel syndrome 46.03 10.11 404 910709 23524 89693810
Skin exfoliation 46.02 10.11 448 910665 67465 89649869
Cytopenia 45.90 10.11 65 911048 17384 89699950
Gastrointestinal haemorrhage 45.38 10.11 636 910477 89612 89627722
Neuroleptic malignant syndrome 45.15 10.11 51 911062 15045 89702289
Atrioventricular block complete 45.15 10.11 21 911092 9790 89707544
Circulatory collapse 45.13 10.11 116 910997 24788 89692546
Vertigo 45.03 10.11 466 910647 69345 89647989
Coagulopathy 44.94 10.11 105 911008 23184 89694150
Sensitisation 44.92 10.11 117 910996 4058 89713276
Pain in jaw 44.84 10.11 290 910823 47695 89669639
Adjustment disorder with depressed mood 44.78 10.11 811 910302 55942 89661392
Hypercholesterolaemia 44.76 10.11 1330 909783 99562 89617772
Stress cardiomyopathy 44.63 10.11 41 911072 13314 89704020
C-reactive protein increased 44.39 10.11 2240 908873 179149 89538185
Joint laxity 44.31 10.11 88 911025 2540 89714794
Interstitial lung disease 44.13 10.11 523 910590 75882 89641452
Second primary malignancy 43.62 10.11 25 911088 10353 89706981
Metastases to central nervous system 43.56 10.11 68 911045 17474 89699860
Ischaemic stroke 43.53 10.11 99 911014 22067 89695267
Diabetes mellitus 43.52 10.11 429 910684 64446 89652888
Haemorrhage intracranial 43.44 10.11 53 911060 15109 89702225
Acute respiratory failure 43.43 10.11 253 910860 42665 89674669
Paradoxical drug reaction 43.27 10.11 4 911109 5762 89711572
Acute respiratory distress syndrome 43.02 10.11 146 910967 28540 89688794
Gait inability 43.02 10.11 1842 909271 144614 89572720
Cardiotoxicity 43.00 10.11 31 911082 11358 89705976
Speech disorder 42.85 10.11 275 910838 45310 89672024
Ejection fraction 42.79 10.11 94 911019 2917 89714417
Rash maculo-papular 42.66 10.11 239 910874 40694 89676640
Colitis 42.65 10.11 473 910640 69469 89647865
Lethargy 42.58 10.11 417 910696 62722 89654612
Urinary retention 42.33 10.11 215 910898 37529 89679805
Jaundice 41.94 10.11 176 910937 32341 89684993
Asphyxia 41.75 10.11 10 911103 7093 89710241
International normalised ratio increased 41.70 10.11 291 910822 47025 89670309
Adverse event 41.07 10.11 1505 909608 115913 89601421
Hallucination, visual 40.75 10.11 109 911004 22983 89694351
Polyarthritis 40.74 10.11 320 910793 18030 89699304
Basal cell carcinoma 40.70 10.11 514 910599 32875 89684459
Haematoma 40.69 10.11 228 910885 38820 89678514
Neurologic neglect syndrome 40.62 10.11 19 911094 8828 89708506
Epstein-Barr virus infection 40.59 10.11 27 911086 10317 89707017
White blood cell count decreased 40.54 10.11 1325 909788 165784 89551550
Acute graft versus host disease 40.49 10.11 4 911109 5464 89711870
Breast cancer stage III 40.44 10.11 1124 909989 83323 89634011
Depressed mood 40.37 10.11 317 910796 49905 89667429
Feeling abnormal 40.33 10.11 1327 909786 165908 89551426
Nightmare 40.30 10.11 100 911013 21625 89695709
Bone erosion 40.21 10.11 753 910360 52268 89665066
Aspergillus infection 40.16 10.11 30 911083 10793 89706541
Prescribed underdose 39.80 10.11 1012 910101 74007 89643327
Agranulocytosis 39.47 10.11 199 910914 34803 89682531
Toxic epidermal necrolysis 38.96 10.11 181 910932 32347 89684987
Febrile bone marrow aplasia 38.78 10.11 25 911088 9713 89707621
Tardive dyskinesia 38.41 10.11 32 911081 10898 89706436
Jaundice cholestatic 38.36 10.11 27 911086 10016 89707318
Multiple fractures 38.35 10.11 194 910919 9368 89707966
Abdominal pain 38.34 10.11 3440 907673 392281 89325053
Pulmonary arterial hypertension 38.11 10.11 135 910978 26052 89691282
Haemorrhage 38.11 10.11 480 910633 68889 89648445
Carotid artery thrombosis 38.07 10.11 22 911091 9070 89708264
Asthma-chronic obstructive pulmonary disease overlap syndrome 37.86 10.11 3 911110 4896 89712438
Gestational diabetes 37.85 10.11 208 910905 10374 89706960
Mental disorder 37.44 10.11 182 910931 32136 89685198
Dry skin 37.39 10.11 641 910472 87432 89629902
Transaminases increased 37.23 10.11 220 910893 36972 89680362
Swelling face 37.20 10.11 584 910529 80768 89636566
COVID-19 37.19 10.11 1355 909758 167488 89549846
Drug dose omission by device 37.14 10.11 29 911084 10202 89707132
Muscle twitching 37.10 10.11 122 910991 24080 89693254
Affect lability 36.85 10.11 79 911034 17984 89699350
Coordination abnormal 36.79 10.11 102 911011 21254 89696080
Food allergy 36.71 10.11 405 910708 25073 89692261
Graft versus host disease 36.61 10.11 18 911095 8126 89709208
Dry mouth 36.60 10.11 2230 908883 181829 89535505
Septic shock 36.55 10.11 610 910503 83550 89633784
Acute graft versus host disease in skin 36.51 10.11 3 911110 4753 89712581
Deep vein thrombosis 36.30 10.11 675 910438 90945 89626389
Lower limb fracture 36.18 10.11 1115 909998 83898 89633436
Rebound effect 36.14 10.11 25 911088 9359 89707975
Clostridium difficile colitis 36.04 10.11 142 910971 26564 89690770
Erythema multiforme 35.95 10.11 42 911071 12204 89705130
Cardiomyopathy 35.94 10.11 95 911018 20111 89697223
Injection site reaction 35.63 10.11 1194 909919 90886 89626448
Haemoptysis 35.57 10.11 193 910920 33127 89684207
Device use error 35.56 10.11 14 911099 7207 89710127
Psychomotor hyperactivity 35.45 10.11 46 911067 12767 89704567
Accidental overdose 35.26 10.11 155 910958 28118 89689216
Polycystic ovaries 35.22 10.11 131 910982 5523 89711811
Joint stiffness 35.22 10.11 1031 910082 77011 89640323
Substance abuse 35.13 10.11 6 911107 5400 89711934
Dyspnoea exertional 35.09 10.11 513 910600 71775 89645559
Ear infection 34.90 10.11 934 910179 68841 89648493
Pathogen resistance 34.90 10.11 19 911094 8096 89709238
Tubulointerstitial nephritis 34.69 10.11 134 910979 25209 89692125
Orthostatic hypotension 34.56 10.11 262 910851 41565 89675769
Anuria 34.41 10.11 60 911053 14758 89702576
Subarachnoid haemorrhage 34.32 10.11 81 911032 17823 89699511
Lip swelling 34.25 10.11 237 910876 38373 89678961
Neck deformity 34.17 10.11 71 911042 2118 89715216
Tumour lysis syndrome 34.10 10.11 37 911076 11115 89706219
BK virus infection 34.08 10.11 3 911110 4495 89712839
Delusion 34.03 10.11 54 911059 13786 89703548
Cytomegalovirus infection reactivation 33.93 10.11 18 911095 7782 89709552
Foetal exposure during pregnancy 33.87 10.11 614 910499 42361 89674973
Genital haemorrhage 33.76 10.11 23 911090 8679 89708655
Multiple-drug resistance 33.74 10.11 18 911095 7758 89709576
Bone pain 33.63 10.11 430 910683 61553 89655781
Pericardial effusion 33.21 10.11 225 910888 36608 89680726
Irritability 33.08 10.11 216 910897 35446 89681888
Paralysis 33.02 10.11 40 911073 11438 89705896
Device related infection 32.99 10.11 140 910973 25646 89691688
Adjustment disorder 32.94 10.11 29 911084 9613 89707721
Pain in extremity 32.83 10.11 5084 906029 445445 89271889
Bradyphrenia 32.48 10.11 18 911095 7594 89709740
Motor dysfunction 32.28 10.11 93 911020 19137 89698197
Leukocytosis 32.27 10.11 181 910932 30809 89686525
Brain oedema 32.26 10.11 80 911033 17305 89700029
Sinus bradycardia 32.25 10.11 77 911036 16875 89700459
Lymphocyte count decreased 32.16 10.11 213 910900 34837 89682497
Labelled drug-drug interaction medication error 32.12 10.11 61 911052 14521 89702813
Respiratory acidosis 32.12 10.11 21 911092 8098 89709236
Pulmonary hypertension 32.08 10.11 273 910840 42250 89675084
Bone marrow failure 32.04 10.11 191 910922 32030 89685304
Balance disorder 32.02 10.11 737 910376 96343 89620991
Product administration error 31.67 10.11 147 910966 26276 89691058
Onychomycosis 31.59 10.11 540 910573 36836 89680498
Hypoaesthesia 31.57 10.11 3615 907498 310595 89406739
Foetal death 31.52 10.11 333 910780 20390 89696944
Myopathy 31.15 10.11 55 911058 13463 89703871
Osteoporosis 31.07 10.11 1226 909887 95305 89622029
Blood urea increased 30.93 10.11 179 910934 30234 89687100
Immune reconstitution inflammatory syndrome 30.82 10.11 16 911097 7003 89710331
Oliguria 30.59 10.11 37 911076 10587 89706747
Bradykinesia 30.52 10.11 15 911098 6773 89710561
Caesarean section 30.39 10.11 303 910810 18274 89699060
Treatment noncompliance 30.29 10.11 353 910760 51374 89665960
Pallor 30.16 10.11 210 910903 33955 89683379
Product dose omission issue 30.10 10.11 2523 908590 289164 89428170
Aspiration 30.08 10.11 71 911042 15622 89701712
Hyperbilirubinaemia 30.08 10.11 59 911054 13877 89703457
Sleep disorder 29.69 10.11 2344 908769 195686 89521648
Device dislocation 29.55 10.11 190 910923 31292 89686042
Small for dates baby 29.53 10.11 114 910999 4893 89712441
Renal tubular necrosis 29.40 10.11 64 911049 14491 89702843
Blood pressure diastolic decreased 29.38 10.11 405 910708 26421 89690913
Heart rate decreased 29.33 10.11 725 910388 52780 89664554
Drug tolerance decreased 29.29 10.11 470 910643 31660 89685674
Sensory loss 29.19 10.11 89 911024 17986 89699348
Ketoacidosis 28.98 10.11 10 911103 5585 89711749
Nodule 28.87 10.11 402 910711 26284 89691050
C-reactive protein 28.66 10.11 459 910654 30908 89686426
Eosinophil count increased 28.57 10.11 55 911058 13026 89704308
Exostosis 28.54 10.11 718 910395 52416 89664918
Ileus 28.52 10.11 79 911034 16467 89700867
Premature labour 28.46 10.11 231 910882 13145 89704189
Product administered to patient of inappropriate age 28.46 10.11 6 911107 4647 89712687
Arterial occlusive disease 28.36 10.11 51 911062 12395 89704939
Acidosis 28.29 10.11 53 911060 12683 89704651
Graft versus host disease in gastrointestinal tract 28.23 10.11 5 911108 4383 89712951
Lupus vulgaris 28.22 10.11 622 910491 44437 89672897
Hepatitis acute 28.20 10.11 41 911072 10846 89706488
Lymphopenia 28.19 10.11 126 910987 22755 89694579
Cytomegalovirus viraemia 28.18 10.11 21 911092 7565 89709769
Graft versus host disease in skin 28.06 10.11 3 911110 3850 89713484
Right ventricular failure 27.95 10.11 99 911014 19106 89698228
Laryngitis 27.91 10.11 688 910425 50065 89667269
Cyanosis 27.84 10.11 101 911012 19354 89697980
Blood pressure diastolic increased 27.53 10.11 223 910890 12683 89704651
Forced expiratory volume decreased 27.40 10.11 12 911101 5796 89711538
Eye pruritus 27.34 10.11 175 910938 28852 89688482
Disability 27.31 10.11 568 910545 40177 89677157
Schizoaffective disorder 27.00 10.11 9 911104 5138 89712196
Blood lactic acid increased 26.98 10.11 29 911084 8749 89708585
Acute pulmonary oedema 26.91 10.11 34 911079 9546 89707788
Pulseless electrical activity 26.91 10.11 30 911083 8902 89708432
Epistaxis 26.75 10.11 651 910462 84474 89632860
Tinnitus 26.47 10.11 291 910822 42811 89674523
Electrocardiogram QRS complex prolonged 26.46 10.11 21 911092 7327 89710007
Toxic encephalopathy 26.45 10.11 29 911084 8670 89708664
Lung disorder 26.35 10.11 1797 909316 148086 89569248
Acute myocardial infarction 26.31 10.11 224 910889 34666 89682668
Hallucination, auditory 26.27 10.11 78 911035 15897 89701437
Product prescribing error 26.26 10.11 186 910927 29959 89687375
Adenovirus infection 26.22 10.11 7 911106 4615 89712719
Skin toxicity 26.19 10.11 18 911095 6761 89710573
Onychomadesis 26.03 10.11 626 910487 45372 89671962
Tenderness 26.01 10.11 397 910716 26471 89690863
X-ray abnormal 25.95 10.11 619 910494 44805 89672529
Sexual dysfunction 25.91 10.11 8 911105 4796 89712538
Complication associated with device 25.88 10.11 104 911009 19345 89697989
Pulmonary congestion 25.80 10.11 104 911009 19329 89698005
Atrial tachycardia 25.80 10.11 14 911099 5976 89711358
Retinitis 25.74 10.11 536 910577 37922 89679412
Hypernatraemia 25.66 10.11 34 911079 9353 89707981
Glycosylated haemoglobin increased 25.58 10.11 76 911037 15486 89701848
Intentional product misuse 25.56 10.11 695 910418 88909 89628425
Macular degeneration 25.50 10.11 251 910862 37719 89679615
Shock haemorrhagic 25.44 10.11 53 911060 12192 89705142
Maternal drugs affecting foetus 25.37 10.11 111 911002 5044 89712290
Upper respiratory tract infection 25.19 10.11 1553 909560 126765 89590569
Dysgeusia 25.16 10.11 374 910739 52186 89665148
Maternal exposure before pregnancy 25.15 10.11 196 910917 11017 89706317
Haemodynamic instability 25.08 10.11 50 911063 11689 89705645
Paranoia 25.06 10.11 58 911055 12850 89704484
Hallucinations, mixed 25.02 10.11 14 911099 5875 89711459
Skin haemorrhage 25 10.11 120 910993 21260 89696074
Transplant dysfunction 24.79 10.11 11 911102 5271 89712063
Subdural haematoma 24.77 10.11 85 911028 16560 89700774
Bradypnoea 24.69 10.11 8 911105 4650 89712684
Generalised tonic-clonic seizure 24.60 10.11 228 910885 34675 89682659
Wheelchair user 24.56 10.11 148 910965 7637 89709697
Anti-cyclic citrullinated peptide antibody 24.37 10.11 397 910716 26824 89690510
Dyspepsia 24.31 10.11 2311 908802 195849 89521485
Total lung capacity increased 24.29 10.11 10 911103 5011 89712323
Pseudomonas infection 24.14 10.11 73 911040 14792 89702542
Immune effector cell-associated neurotoxicity syndrome 24.09 10.11 14 911099 5754 89711580
Gangrene 24.09 10.11 59 911054 12817 89704517
Generalised oedema 24.03 10.11 104 911009 18949 89698385
Acute coronary syndrome 24.02 10.11 45 911068 10768 89706566
Chronic graft versus host disease 23.99 10.11 6 911107 4133 89713201
Polyuria 23.91 10.11 40 911073 10000 89707334
Hyperthermia 23.86 10.11 42 911071 10293 89707041
Complication of device insertion 23.56 10.11 43 911070 10393 89706941
Breast cancer female 23.54 10.11 74 911039 14812 89702522
Sputum discoloured 23.52 10.11 115 910998 20276 89697058
Device breakage 23.51 10.11 68 911045 13976 89703358
Dysphonia 23.39 10.11 470 910643 62614 89654720
Hypophosphataemia 23.38 10.11 74 911039 14780 89702554
Tuberculosis 23.17 10.11 210 910903 12339 89704995
Hepatic cirrhosis 23.16 10.11 815 910298 62438 89654896
Sleep terror 23.08 10.11 8 911105 4456 89712878
Pulmonary alveolar haemorrhage 23.07 10.11 16 911097 5982 89711352
Hypertension 23.00 10.11 5066 906047 452466 89264868
Systemic inflammatory response syndrome 22.99 10.11 19 911094 6497 89710837
Joint dislocation 22.94 10.11 599 910514 43983 89673351
Panic attack 22.81 10.11 163 910950 26202 89691132
Anti-neutrophil cytoplasmic antibody positive vasculitis 22.74 10.11 6 911107 3987 89713347
Coronary artery disease 22.69 10.11 222 910891 33401 89683933
Dysuria 22.64 10.11 270 910843 39131 89678203
Mood altered 22.60 10.11 92 911021 17052 89700282
Hepatitis B reactivation 22.58 10.11 6 911107 3968 89713366
Troponin increased 22.46 10.11 64 911049 13217 89704117
Premature rupture of membranes 22.46 10.11 113 911000 5445 89711889
Renal injury 22.43 10.11 43 911070 10200 89707134
Complication of device removal 22.37 10.11 18 911095 6237 89711097
Chills 22.36 10.11 1091 910022 130890 89586444
Smear cervix abnormal 22.32 10.11 76 911037 3066 89714268
Incorrect dose administered 22.31 10.11 613 910500 78317 89639017
Hospitalisation 22.27 10.11 1056 910057 127044 89590290
Hypervolaemia 22.23 10.11 216 910897 32541 89684793
Immune-mediated enterocolitis 22.18 10.11 10 911103 4747 89712587
Enterocolitis 22.14 10.11 45 911068 10445 89706889
Bundle branch block left 22.13 10.11 28 911085 7857 89709477
Hyperlactacidaemia 22.11 10.11 7 911106 4129 89713205
Cardiac failure acute 22.05 10.11 55 911058 11874 89705460
Fear 22.04 10.11 89 911024 16533 89700801
Latent tuberculosis 22.03 10.11 73 911040 2903 89714431
Hyperuricaemia 22.02 10.11 21 911092 6698 89710636
Dissociation 21.99 10.11 21 911092 6694 89710640
Ventricular septal defect 21.90 10.11 110 911003 5297 89712037
Peripheral sensory neuropathy 21.90 10.11 37 911076 9213 89708121
Bacteraemia 21.75 10.11 133 910980 22167 89695167
Lupus-like syndrome 21.68 10.11 644 910469 48202 89669132
Product preparation error 21.67 10.11 44 911069 10217 89707117
Pyrexia 21.65 10.11 6113 905000 654372 89062962
Blood lactate dehydrogenase increased 21.63 10.11 162 910951 25770 89691564
Gastroenteritis viral 21.62 10.11 427 910686 29928 89687406
Body temperature decreased 21.57 10.11 348 910765 23468 89693866
Hyperprolactinaemia 21.56 10.11 14 911099 5419 89711915
Rhinovirus infection 21.52 10.11 17 911096 5946 89711388
Hypocalcaemia 21.50 10.11 298 910815 42070 89675264
Crying 21.49 10.11 160 910953 25485 89691849
Acute chest syndrome 21.26 10.11 40 911073 1108 89716226
Ataxia 21.25 10.11 101 911012 17941 89699393
Product storage error 21.19 10.11 118 910995 20123 89697211
Presyncope 21.05 10.11 211 910902 31594 89685740
Klebsiella infection 21.03 10.11 45 911068 10252 89707082
Haematuria 21.01 10.11 237 910876 34700 89682634
Maternal exposure timing unspecified 20.92 10.11 330 910783 22153 89695181
Drug hypersensitivity 20.85 10.11 4228 906885 459381 89257953
Injection site erythema 20.81 10.11 1200 909913 97302 89620032
Oedema peripheral 20.79 10.11 2272 908841 255643 89461691
Systemic candida 20.77 10.11 12 911101 4947 89712387
Progressive multifocal leukoencephalopathy 20.65 10.11 84 911029 15571 89701763
Lymphoedema 20.62 10.11 70 911043 13683 89703651
Throat tightness 20.61 10.11 193 910920 29291 89688043
Hypoalbuminaemia 20.53 10.11 86 911027 15811 89701523
Ear pain 20.51 10.11 741 910372 56961 89660373
Hepatitis cholestatic 20.49 10.11 34 911079 8527 89708807
Electrolyte imbalance 20.45 10.11 147 910966 23598 89693736
Glomerular filtration rate decreased 20.41 10.11 94 911019 16838 89700496
Eating disorder 20.39 10.11 182 910931 27891 89689443
Blindness 20.29 10.11 170 910943 26398 89690936
Pneumonitis 20.22 10.11 317 910796 43853 89673481
Atrioventricular block 20.19 10.11 36 911077 8779 89708555
Hypoglycaemic coma 20.15 10.11 3 911110 2987 89714347
Nail disorder 20.14 10.11 755 910358 58312 89659022
Blood potassium decreased 20.05 10.11 348 910765 47379 89669955
Foot operation 20.00 10.11 157 910956 8844 89708490
Device issue 19.94 10.11 195 910918 29342 89687992
Diabetes insipidus 19.94 10.11 4 911109 3208 89714126
Dysmorphism 19.92 10.11 64 911049 2504 89714830
Pneumatosis intestinalis 19.89 10.11 5 911108 3432 89713902
Haematemesis 19.80 10.11 230 910883 33496 89683838
Nephrectomy 19.78 10.11 54 911059 1927 89715407
Chronic obstructive pulmonary disease 19.69 10.11 578 910535 73251 89644083
Hypertransaminasaemia 19.58 10.11 87 911026 15738 89701596
Cholelithiasis 19.52 10.11 391 910722 52115 89665219
Product substitution issue 19.39 10.11 104 911009 17904 89699430
Exposure via skin contact 19.29 10.11 50 911063 10655 89706679
Rheumatoid nodule 19.14 10.11 297 910816 19869 89697465
Hyperthyroidism 19.03 10.11 107 911006 18203 89699131
Wheezing 19.01 10.11 2701 908412 235379 89481955
Laryngospasm 19.00 10.11 5 911108 3328 89714006
Rales 19.00 10.11 88 911025 15739 89701595
Malignant mediastinal neoplasm 18.93 10.11 43 911070 1365 89715969
Nystagmus 18.93 10.11 27 911086 7200 89710134
Facial paralysis 18.86 10.11 86 911027 15448 89701886
Oedema 18.85 10.11 2295 908818 198000 89519334
Fall 18.84 10.11 4424 906689 477386 89239948
Urinary incontinence 18.79 10.11 265 910848 37301 89680033
Nephropathy toxic 18.74 10.11 65 911048 12623 89704711
Laryngeal oedema 18.73 10.11 25 911088 6856 89710478
Eczema 18.68 10.11 397 910716 52473 89664861
Neck mass 18.66 10.11 83 911030 3799 89713535
Blood pressure inadequately controlled 18.65 10.11 21 911092 6203 89711131
Limb deformity 18.64 10.11 87 911026 4065 89713269
Blood phosphorus decreased 18.62 10.11 14 911099 5020 89712314
Personality change 18.54 10.11 28 911085 7293 89710041
Device leakage 18.52 10.11 46 911067 9945 89707389
Device malfunction 18.49 10.11 129 910984 20848 89696486
Inappropriate schedule of product administration 18.43 10.11 1278 909835 148655 89568679
Hypogammaglobulinaemia 18.37 10.11 51 911062 10623 89706711
Erythema 18.27 10.11 2021 909092 227225 89490109
Breast cancer metastatic 18.24 10.11 84 911029 15048 89702286
Drug tolerance 18.23 10.11 267 910846 17649 89699685
Maternal exposure during delivery 18.06 10.11 8 911105 3838 89713496
Pancreatitis 18.05 10.11 549 910564 69277 89648057
Rotator cuff repair 18.00 10.11 60 911053 2394 89714940
Bone lesion 17.92 10.11 23 911090 6414 89710920
End stage renal disease 17.89 10.11 37 911076 8534 89708800
Activated partial thromboplastin time prolonged 17.89 10.11 32 911081 7793 89709541
Bezoar 17.84 10.11 3 911110 2731 89714603
Pruritus genital 17.75 10.11 12 911101 4546 89712788
Affective disorder 17.69 10.11 32 911081 7761 89709573
Myocardial ischaemia 17.67 10.11 75 911038 13739 89703595
Developmental hip dysplasia 17.65 10.11 45 911068 1540 89715794
Salivary hypersecretion 17.54 10.11 41 911072 9051 89708283
Post-traumatic stress disorder 17.40 10.11 26 911087 6802 89710532
Brain injury 17.37 10.11 32 911081 7706 89709628
Abortion incomplete 17.35 10.11 5 911108 3135 89714199
Kidney transplant rejection 17.34 10.11 14 911099 4843 89712491
Dermatitis exfoliative 17.34 10.11 18 911095 5518 89711816
Hepatitis fulminant 17.31 10.11 9 911104 3936 89713398
Intracranial pressure increased 17.30 10.11 26 911087 6785 89710549
Epstein-Barr virus associated lymphoproliferative disorder 17.24 10.11 3 911110 2664 89714670
Intestinal ischaemia 17.18 10.11 40 911073 8843 89708491
Pulmonary toxicity 17.08 10.11 59 911054 11472 89705862
Infective pulmonary exacerbation of cystic fibrosis 17.04 10.11 50 911063 10229 89707105
Respiration abnormal 16.94 10.11 34 911079 7929 89709405
Skin plaque 16.92 10.11 48 911065 9927 89707407
Pneumonia viral 16.85 10.11 40 911073 8783 89708551
Pneumothorax 16.83 10.11 118 910995 19049 89698285
Ankylosing spondylitis 16.79 10.11 204 910909 12929 89704405
Body height below normal 16.79 10.11 54 911059 2114 89715220
Synovial disorder 16.79 10.11 69 911044 3049 89714285
Neutrophilia 16.76 10.11 20 911093 5758 89711576
Injection site pruritus 16.68 10.11 681 910432 53153 89664181
Hyperpyrexia 16.65 10.11 14 911099 4747 89712587
Stillbirth 16.64 10.11 130 910983 7313 89710021
Skin burning sensation 16.60 10.11 122 910991 19489 89697845
Pulmonary haemorrhage 16.38 10.11 35 911078 7978 89709356
Hyperreflexia 16.34 10.11 26 911087 6631 89710703
Disturbance in social behaviour 16.34 10.11 11 911102 4177 89713157
Ventricular extrasystoles 16.30 10.11 73 911040 13177 89704157
Rheumatoid lung 16.29 10.11 83 911030 4020 89713314
Product prescribing issue 16.19 10.11 35 911078 7944 89709390
Staphylococcal infection 16.18 10.11 367 910746 48072 89669262
Enthesopathy 16.17 10.11 155 910958 9249 89708085
Placental disorder 16.17 10.11 44 911069 1567 89715767
Nail operation 16.17 10.11 49 911064 1857 89715477
Endophthalmitis 16.12 10.11 14 911099 4671 89712663
Amylase increased 16.09 10.11 29 911084 7043 89710291
Cystitis haemorrhagic 16.08 10.11 19 911094 5494 89711840
Illness 16.03 10.11 667 910446 81302 89636032
Eosinophilic granulomatosis with polyangiitis 16.02 10.11 3 911110 2527 89714807
Potentiating drug interaction 16.00 10.11 20 911093 5642 89711692
Reversible cerebral vasoconstriction syndrome 15.91 10.11 11 911102 4119 89713215
Hypotonia 15.90 10.11 60 911053 11366 89705968
Atrial septal defect 15.83 10.11 139 910974 8095 89709239
Product adhesion issue 15.79 10.11 17 911096 5125 89712209
Osteonecrosis 15.78 10.11 178 910935 26063 89691271
Blepharospasm 15.75 10.11 695 910418 54750 89662584
Blood glucose decreased 15.68 10.11 155 910958 23274 89694060
Foetal anticonvulsant syndrome 15.65 10.11 26 911087 651 89716683
Head injury 15.60 10.11 220 910893 30968 89686366
Hydronephrosis 15.46 10.11 68 911045 12334 89705000
Ileus paralytic 15.41 10.11 17 911096 5068 89712266
Amenorrhoea 15.39 10.11 63 911050 11659 89705675
Varicella zoster virus infection 15.37 10.11 10 911103 3867 89713467
Diplopia 15.28 10.11 200 910913 28514 89688820
Colitis microscopic 15.27 10.11 59 911054 11100 89706234
Catheter site erythema 15.23 10.11 16 911097 4878 89712456
Drug effective for unapproved indication 15.04 10.11 36 911077 7882 89709452
Deafness transitory 15.03 10.11 50 911063 1993 89715341
Tenosynovitis stenosans 15.02 10.11 79 911034 3874 89713460
Lupus vasculitis 14.94 10.11 24 911089 584 89716750
Synovial fluid analysis 14.89 10.11 62 911051 2756 89714578
Anosmia 14.85 10.11 50 911063 9798 89707536
Cleft lip and palate 14.83 10.11 27 911086 729 89716605
Lung opacity 14.82 10.11 24 911089 6078 89711256
Loose body in joint 14.79 10.11 39 911074 1363 89715971
Synovial cyst 14.79 10.11 182 910931 11570 89705764
Incoherent 14.68 10.11 17 911096 4960 89712374
Type 1 diabetes mellitus 14.67 10.11 16 911097 4796 89712538
Hypoventilation 14.67 10.11 19 911094 5277 89712057
Bundle branch block right 14.66 10.11 20 911093 5433 89711901
Hypercapnia 14.64 10.11 28 911085 6649 89710685
Pain of skin 14.62 10.11 98 911015 15984 89701350
Exercise tolerance decreased 14.60 10.11 34 911079 7517 89709817
Persecutory delusion 14.56 10.11 7 911106 3201 89714133
Subacute cutaneous lupus erythematosus 14.53 10.11 9 911104 3573 89713761
Drug screen positive 14.48 10.11 10 911103 3747 89713587
Nervousness 14.41 10.11 248 910865 33808 89683526
Arthritis infective 14.38 10.11 133 910980 7859 89709475
Hyperammonaemia 14.34 10.11 27 911086 6448 89710886
Clostridium test positive 14.32 10.11 20 911093 5381 89711953
Dementia 14.29 10.11 162 910951 23699 89693635
Pregnancy with contraceptive device 14.21 10.11 18 911095 5048 89712286
Seronegative arthritis 14.18 10.11 260 910853 17974 89699360
Metabolic disorder 14.16 10.11 34 911079 7436 89709898
Finger deformity 14.14 10.11 432 910681 32465 89684869
Ejection fraction abnormal 14.11 10.11 56 911057 2435 89714899
Skin papilloma 14.09 10.11 101 911012 5529 89711805
Congenital arterial malformation 14.05 10.11 17 911096 314 89717020
Postoperative wound infection 14.02 10.11 201 910912 13225 89704109
Visual acuity reduced 14.00 10.11 159 910954 23251 89694083
Ventricular hypokinesia 13.94 10.11 20 911093 5321 89712013
Pyelonephritis 13.86 10.11 142 910971 21174 89696160
Hypophagia 13.85 10.11 266 910847 35671 89681663
Malignant melanoma 13.83 10.11 190 910923 12386 89704948
Catheter site haemorrhage 13.83 10.11 10 911103 3658 89713676
Cardiopulmonary failure 13.83 10.11 13 911100 4175 89713159
Antinuclear antibody positive 13.82 10.11 148 910965 9093 89708241
Immunosuppressant drug level increased 13.79 10.11 16 911097 4664 89712670
Clear cell renal cell carcinoma 13.76 10.11 41 911072 1539 89715795
Spinal stenosis 13.75 10.11 249 910864 17175 89700159
Bacterial infection 13.72 10.11 160 910953 23284 89694050
Localised infection 13.70 10.11 438 910675 33124 89684210
Wrong product administered 13.66 10.11 36 911077 7629 89709705
Bone density increased 13.63 10.11 29 911084 880 89716454
Type I hypersensitivity 13.60 10.11 13 911100 4142 89713192
Pneumonia 13.59 10.11 6003 905110 632056 89085278
Catheter site pain 13.50 10.11 22 911091 5557 89711777
Total lung capacity decreased 13.47 10.11 11 911102 3784 89713550
Nasal obstruction 13.44 10.11 57 911056 2555 89714779
Physical deconditioning 13.43 10.11 3 911110 2232 89715102
Cell death 13.36 10.11 7 911106 3048 89714286
Atrioventricular block second degree 13.36 10.11 15 911098 4437 89712897
Staphylococcal sepsis 13.24 10.11 49 911064 9334 89708000
Inadequate analgesia 13.22 10.11 8 911105 3216 89714118
Ankle arthroplasty 13.21 10.11 60 911053 2771 89714563
Device deployment issue 13.20 10.11 18 911095 4891 89712443
Hot flush 13.18 10.11 477 910636 59011 89658323
Hyperlipidaemia 13.18 10.11 157 910956 22759 89694575
Amyloid arthropathy 13.15 10.11 42 911071 1638 89715696
Respiratory tract congestion 13.13 10.11 195 910918 27215 89690119
Heart rate increased 13.12 10.11 967 910146 111935 89605399
Red blood cell sedimentation rate 13.11 10.11 86 911027 4572 89712762
Limb reduction defect 13.05 10.11 23 911090 605 89716729
Breast feeding 13.04 10.11 28 911085 855 89716479
Blood calcium decreased 13.02 10.11 219 910894 29963 89687371
Polydipsia 12.98 10.11 14 911099 4217 89713117
Cardiac tamponade 12.90 10.11 23 911090 5609 89711725
Loss of employment 12.84 10.11 7 911106 2980 89714354
Eyelid oedema 12.76 10.11 66 911047 11468 89705866
Influenza like illness 12.75 10.11 671 910442 79940 89637394
Device occlusion 12.75 10.11 49 911064 9233 89708101
Immune thrombocytopenia 12.72 10.11 80 911033 13246 89704088
Hypertelorism 12.72 10.11 21 911092 523 89716811
Carotid artery occlusion 12.72 10.11 28 911085 6314 89711020
Intervertebral disc degeneration 12.64 10.11 244 910869 17030 89700304
Alcohol use disorder 12.63 10.11 7 911106 38 89717296
Nocardiosis 12.63 10.11 5 911108 2565 89714769
Cholangitis 12.60 10.11 34 911079 7148 89710186
Human antichimeric antibody positive 12.51 10.11 43 911070 1743 89715591
Ventricular arrhythmia 12.49 10.11 15 911098 4306 89713028
Sneezing 12.48 10.11 218 910895 29651 89687683
Nervous system disorder 12.39 10.11 148 910965 21445 89695889
Neutropenic colitis 12.39 10.11 14 911099 4129 89713205
Metastasis 12.39 10.11 27 911086 6110 89711224
Blood prolactin increased 12.35 10.11 11 911102 3626 89713708
Anhedonia 12.32 10.11 66 911047 11365 89705969
Product residue present 12.29 10.11 15 911098 4276 89713058
Neutrophil count increased 12.27 10.11 130 910983 19260 89698074
Secondary adrenocortical insufficiency 12.25 10.11 4 911109 2314 89715020
Antibody test positive 12.24 10.11 61 911052 2928 89714406
International normalised ratio fluctuation 12.23 10.11 8 911105 3085 89714249
Skin lesion 12.22 10.11 284 910829 37081 89680253
Dependence 12.22 10.11 3 911110 2092 89715242
Impaired gastric emptying 12.18 10.11 77 911036 12732 89704602
Retrognathia 12.17 10.11 21 911092 543 89716791
Haemodialysis 12.13 10.11 46 911067 8701 89708633
Acute graft versus host disease in intestine 12.11 10.11 3 911110 2080 89715254
Cardiac failure chronic 12.10 10.11 24 911089 5622 89711712
Abdominal pain lower 12.05 10.11 222 910891 29955 89687379
Poor quality device used 12.05 10.11 4 911109 2289 89715045
Pathological fracture 12.02 10.11 53 911060 9607 89707727
Drug abuser 12.01 10.11 6 911107 2684 89714650
Dermatitis bullous 12.00 10.11 58 911055 10258 89707076
Dermatitis acneiform 11.98 10.11 29 911084 6325 89711009
Euglycaemic diabetic ketoacidosis 11.93 10.11 28 911085 6173 89711161
Pulse absent 11.92 10.11 27 911086 6028 89711306
Heparin-induced thrombocytopenia 11.89 10.11 22 911091 5290 89712044
Malaise 11.89 10.11 5522 905591 580464 89136870
Product monitoring error 11.88 10.11 17 911096 4527 89712807
Lymphatic fistula 11.87 10.11 37 911076 1424 89715910
Femur fracture 11.87 10.11 572 910541 45510 89671824
Cross sensitivity reaction 11.84 10.11 7 911106 2850 89714484
Colorectal cancer 11.81 10.11 13 911100 3880 89713454
Osteolysis 11.74 10.11 11 911102 3539 89713795
Blood sodium decreased 11.71 10.11 201 910912 27412 89689922
Venoocclusive disease 11.70 10.11 5 911108 2450 89714884
Hypoxic-ischaemic encephalopathy 11.68 10.11 18 911095 4650 89712684
Uterine perforation 11.63 10.11 38 911075 7516 89709818
Fracture delayed union 11.61 10.11 53 911060 2453 89714881
Central nervous system lesion 11.60 10.11 69 911044 11577 89705757
Polyhydramnios 11.59 10.11 53 911060 2455 89714879
Autoimmune hepatitis 11.58 10.11 59 911054 10292 89707042
Lymphadenopathy 11.56 10.11 361 910752 45414 89671920
Quadriplegia 11.53 10.11 4 911109 2227 89715107
Cardiomegaly 11.53 10.11 128 910985 18797 89698537
Malnutrition 11.51 10.11 125 910988 18433 89698901
Infusion site pain 11.44 10.11 135 910978 19603 89697731
Metastases to peritoneum 11.41 10.11 15 911098 4140 89713194
Implant site pain 11.40 10.11 6 911107 2606 89714728
Immunisation 11.38 10.11 4 911109 2209 89715125
Aplasia 11.38 10.11 14 911099 3977 89713357
Pre-eclampsia 11.38 10.11 165 910948 10883 89706451
Major depression 11.34 10.11 57 911056 9978 89707356
Spondylitis 11.32 10.11 203 910910 13975 89703359
Congestive cardiomyopathy 11.32 10.11 37 911076 7317 89710017
Areflexia 11.30 10.11 12 911101 3641 89713693
Hypokinesia 11.30 10.11 102 911011 15595 89701739
Hereditary angioedema 11.28 10.11 52 911061 9313 89708021
Soft tissue disorder 11.26 10.11 16 911097 4274 89713060
Tetany 11.19 10.11 6 911107 2578 89714756
Femoral hernia incarcerated 11.17 10.11 37 911076 1471 89715863
Lupus nephritis 11.14 10.11 85 911028 4747 89712587
Immune-mediated hepatitis 11.13 10.11 8 911105 2936 89714398
Abdominal distension 11.11 10.11 1146 909967 129455 89587879
Retinal haemorrhage 11.11 10.11 26 911087 5738 89711596
Pneumonia bacterial 11.10 10.11 79 911034 12711 89704623
Pneumonia fungal 11.09 10.11 35 911078 6996 89710338
Wound infection pseudomonas 11.08 10.11 45 911068 1978 89715356
Bronchial secretion retention 11.05 10.11 12 911101 3603 89713731
Muscle contractions involuntary 11.01 10.11 8 911105 2920 89714414
Incorrect dose administered by device 10.96 10.11 26 911087 5711 89711623
Gastroschisis 10.96 10.11 17 911096 401 89716933
Skin cancer 10.95 10.11 194 910919 13325 89704009
Pulmonary function test abnormal 10.95 10.11 7 911106 2732 89714602
Neoplasm recurrence 10.90 10.11 10 911103 3249 89714085
Infection reactivation 10.89 10.11 3 911110 1937 89715397
Dialysis 10.82 10.11 68 911045 11261 89706073
Cyst 10.81 10.11 230 910883 16331 89701003
Metastases to meninges 10.76 10.11 13 911100 3722 89713612
Exomphalos 10.76 10.11 20 911093 549 89716785
Speech disorder developmental 10.74 10.11 27 911086 916 89716418
Ventricular dysfunction 10.73 10.11 13 911100 3718 89713616
Middle insomnia 10.72 10.11 112 911001 16639 89700695
Haemorrhage in pregnancy 10.72 10.11 47 911066 2138 89715196
Hypovolaemic shock 10.71 10.11 36 911077 7058 89710276
Breast cancer stage I 10.69 10.11 55 911058 9569 89707765
Haemorrhage subcutaneous 10.68 10.11 11 911102 3385 89713949
Hypovolaemia 10.68 10.11 77 911036 12354 89704980
Blood loss anaemia 10.68 10.11 59 911054 10081 89707253
Long QT syndrome 10.66 10.11 15 911098 4022 89713312
Device use issue 10.62 10.11 13 911100 3700 89713634
Therapy interrupted 10.61 10.11 404 910709 49704 89667630
Enterococcal infection 10.59 10.11 58 911055 9933 89707401
Atrial flutter 10.58 10.11 64 911049 10694 89706640
Lip oedema 10.58 10.11 19 911094 4620 89712714
Steroid diabetes 10.55 10.11 6 911107 2496 89714838
Hypertensive crisis 10.55 10.11 121 910992 17663 89699671
Chorea 10.54 10.11 4 911109 2106 89715228
Short stature 10.52 10.11 29 911084 1041 89716293
Lipase increased 10.46 10.11 67 911046 11044 89706290
Crohn's disease 10.44 10.11 84 911029 4767 89712567
Iron deficiency anaemia 10.44 10.11 171 910942 23491 89693843
Disorganised speech 10.42 10.11 3 911110 1882 89715452
Thirst 10.41 10.11 109 911004 16186 89701148
Oculogyric crisis 10.38 10.11 6 911107 2473 89714861
Pemphigoid 10.36 10.11 51 911062 8975 89708359
Apnoea 10.34 10.11 54 911059 9360 89707974
Dermatitis 10.33 10.11 159 910954 22061 89695273
Nail injury 10.32 10.11 24 911089 774 89716560
Hemianopia 10.31 10.11 4 911109 2078 89715256
Trigeminal neuralgia 10.27 10.11 16 911097 4115 89713219
Needle issue 10.27 10.11 90 911023 13844 89703490
Sickle cell anaemia 10.23 10.11 21 911092 621 89716713
Lacrimation increased 10.22 10.11 201 910912 26861 89690473
Terminal state 10.21 10.11 8 911105 2810 89714524
Leukoencephalopathy 10.20 10.11 21 911092 4852 89712482
Brain abscess 10.17 10.11 8 911105 2804 89714530
Haematochezia 10.17 10.11 596 910517 70317 89647017

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 558.49 10.24 963 260291 41477 42318604
Toxicity to various agents 428.31 10.24 464 260790 228672 42131409
Drug abuse 338.67 10.24 110 261144 104661 42255420
Completed suicide 300.13 10.24 108 261146 96357 42263724
Drug interaction 274.79 10.24 787 260467 266212 42093869
Arthralgia 259.10 10.24 2145 259109 203093 42156988
Foetal exposure during pregnancy 255.91 10.24 753 260501 46558 42313523
Psoriatic arthropathy 240.50 10.24 496 260758 24471 42335610
Intentional overdose 168.01 10.24 53 261201 51403 42308678
Psoriasis 153.69 10.24 648 260606 47956 42312125
Joint swelling 145.14 10.24 810 260444 67212 42292869
Sickle cell anaemia with crisis 129.68 10.24 155 261099 4735 42355346
Acute kidney injury 129.53 10.24 1535 259719 365802 41994279
Dysmorphism 120.59 10.24 124 261130 3192 42356889
Musculoskeletal stiffness 110.93 10.24 669 260585 57096 42302985
Arthritis 103.45 10.24 521 260733 41544 42318537
Hepatic function abnormal 103.42 10.24 98 261156 51469 42308612
Coma 102.54 10.24 106 261148 53448 42306633
Pain 101.93 10.24 2085 259169 242763 42117318
Rhabdomyolysis 98.03 10.24 207 261047 77812 42282269
Serotonin syndrome 95.02 10.24 21 261233 25824 42334257
Blood pressure systolic abnormal 89.70 10.24 138 261116 5390 42354691
Blood pressure fluctuation 89.15 10.24 364 260890 26544 42333537
Drug resistance 88.24 10.24 50 261204 34198 42325883
Overdose 88.23 10.24 339 260915 104925 42255156
Suicide attempt 83.00 10.24 96 261158 46004 42314077
Febrile neutropenia 82.99 10.24 733 260521 184970 42175111
Blood pressure systolic increased 80.83 10.24 363 260891 27605 42332476
Disease progression 79.70 10.24 534 260720 143122 42216959
Nasopharyngitis 79.02 10.24 825 260429 83171 42276910
Sedation 77.79 10.24 45 261209 30430 42329651
Enthesopathy 77.60 10.24 120 261134 4708 42355373
Synovitis 75.90 10.24 239 261015 15328 42344753
Arthropathy 74.47 10.24 369 260885 29228 42330853
Blood pressure diastolic abnormal 74.01 10.24 134 261120 5994 42354087
Small for dates baby 73.89 10.24 123 261131 5140 42354941
Fatigue 73.02 10.24 3315 257939 432326 41927755
Weight decreased 67.45 10.24 1710 259544 206238 42153843
Premature baby 66.52 10.24 300 260954 22853 42337228
Tenosynovitis 66.28 10.24 110 261144 4585 42355496
Exposure during pregnancy 65.53 10.24 155 261099 8393 42351688
Peripheral swelling 62.90 10.24 837 260417 89433 42270648
Product use in unapproved indication 62.81 10.24 776 260478 183680 42176401
Angioedema 61.90 10.24 103 261151 42374 42317707
Speech disorder developmental 61.53 10.24 73 261181 2212 42357869
Coombs positive haemolytic anaemia 59.67 10.24 54 261200 1181 42358900
Altered state of consciousness 59.37 10.24 55 261199 29204 42330877
Pain in extremity 58.81 10.24 1271 259983 149333 42210748
C-reactive protein abnormal 58.49 10.24 156 261098 9105 42350976
Cytomegalovirus infection 58.45 10.24 67 261187 32239 42327842
Poisoning 58.13 10.24 10 261244 14689 42345392
Drug reaction with eosinophilia and systemic symptoms 57.70 10.24 106 261148 41969 42318112
Depressed level of consciousness 56.37 10.24 132 261122 47838 42312243
Foetal anticonvulsant syndrome 55.04 10.24 51 261203 1151 42358930
Neonatal respiratory distress syndrome 54.90 10.24 99 261155 4414 42355667
Infusion related reaction 54.72 10.24 592 260662 60214 42299867
Bradycardia 54.57 10.24 304 260950 85180 42274901
Osteoarthritis 52.26 10.24 291 260963 24114 42335967
Lactic acidosis 52.03 10.24 126 261128 45135 42314946
Drug ineffective 51.97 10.24 3251 258003 626946 41733135
Death 51.88 10.24 2361 258893 468824 41891257
Maternal exposure during pregnancy 51.84 10.24 125 261129 6853 42353228
Off label use 51.78 10.24 3298 257956 635037 41725044
Haemoglobin decreased 51.71 10.24 1118 260136 131353 42228728
Juvenile idiopathic arthritis 51.69 10.24 72 261182 2567 42357514
Heart rate decreased 51.48 10.24 392 260862 36140 42323941
Renal impairment 51.46 10.24 430 260824 109798 42250283
Blood pressure diastolic increased 50.03 10.24 117 261137 6288 42353793
Haemolysis 49.33 10.24 150 261104 9439 42350642
Grip strength decreased 49.23 10.24 83 261171 3505 42356576
Neuroleptic malignant syndrome 48.96 10.24 36 261218 21436 42338645
Respiratory arrest 48.19 10.24 62 261192 28362 42331719
Myelosuppression 47.81 10.24 111 261143 40350 42319731
Cardiac failure 47.58 10.24 422 260832 106434 42253647
Abdominal discomfort 47.23 10.24 685 260569 74570 42285511
Hypoglycaemia neonatal 47.19 10.24 62 261192 2088 42357993
Alanine aminotransferase abnormal 46.16 10.24 97 261157 4847 42355234
Sopor 46.03 10.24 12 261242 13190 42346891
Low birth weight baby 45.05 10.24 149 261105 9806 42350275
Learning disorder 44.84 10.24 44 261210 1069 42359012
Delirium 44.06 10.24 169 261085 52350 42307731
Maternal drugs affecting foetus 43.91 10.24 82 261172 3757 42356324
Cryptorchism 43.79 10.24 58 261196 1969 42358112
Suicidal ideation 43.69 10.24 150 261104 48011 42312070
Hypospadias 43.07 10.24 78 261176 3489 42356592
Renal failure 42.95 10.24 621 260633 143105 42216976
Colitis ulcerative 42.73 10.24 291 260963 25884 42334197
Pathogen resistance 42.71 10.24 9 261245 11441 42348640
Acute hepatic failure 42.46 10.24 26 261228 17047 42343034
Blood pressure increased 41.96 10.24 867 260387 101061 42259020
Psychotic disorder 41.47 10.24 72 261182 29136 42330945
Drug use disorder 40.93 10.24 7 261247 10326 42349755
Autism spectrum disorder 40.84 10.24 69 261185 2919 42357162
Rheumatoid nodule 40.72 10.24 69 261185 2926 42357155
Cardiac arrest 40.22 10.24 452 260802 108868 42251213
Cytokine release syndrome 40.18 10.24 139 261115 44388 42315693
Joint effusion 39.97 10.24 102 261152 5795 42354286
Therapeutic product effect decreased 39.89 10.24 391 260863 38759 42321322
Neurotoxicity 39.67 10.24 52 261202 23599 42336482
Shock 39.36 10.24 74 261180 29047 42331034
Lower respiratory tract infection 39.32 10.24 406 260848 40800 42319281
Malignant neoplasm progression 39.17 10.24 450 260804 107950 42252131
Palmar-plantar erythrodysaesthesia syndrome 39.09 10.24 41 261213 20541 42339540
Atrial septal defect 38.99 10.24 122 261132 7797 42352284
Foot deformity 38.96 10.24 92 261162 4976 42355105
Blood pressure diastolic decreased 38.94 10.24 146 261108 10229 42349852
Respiratory failure 38.85 10.24 552 260702 127580 42232501
Knee arthroplasty 38.47 10.24 130 261124 8651 42351430
Lymphadenitis 38.40 10.24 61 261193 2450 42357631
Haematochezia 37.89 10.24 535 260719 57901 42302180
Jaundice neonatal 37.63 10.24 56 261198 2123 42357958
Maternal exposure during breast feeding 37.52 10.24 47 261207 1508 42358573
Agitation 37.18 10.24 236 261018 64078 42296003
Tachycardia 37.17 10.24 418 260836 100669 42259412
Venoocclusive liver disease 36.62 10.24 9 261245 10293 42349788
Multiple organ dysfunction syndrome 36.56 10.24 399 260855 96636 42263445
Hypokalaemia 36.13 10.24 274 260980 71447 42288634
Immune reconstitution inflammatory syndrome 35.78 10.24 9 261245 10134 42349947
Syndactyly 35.76 10.24 36 261218 903 42359178
Cytomegalovirus infection reactivation 35.62 10.24 12 261242 11166 42348915
Intentional self-injury 35.30 10.24 25 261229 15177 42344904
Anaphylactic shock 35.22 10.24 56 261198 23461 42336620
Sinusitis 34.38 10.24 442 260812 46850 42313231
Post transplant lymphoproliferative disorder 34.36 10.24 7 261247 9113 42350968
Hand deformity 34.11 10.24 73 261181 3695 42356386
Wound 33.96 10.24 200 261054 16917 42343164
Akathisia 33.69 10.24 11 261243 10440 42349641
Metabolic acidosis 33.31 10.24 184 261070 51674 42308407
Substance abuse 33.21 10.24 7 261247 8898 42351183
Hypoglycaemia 32.90 10.24 223 261031 59631 42300450
Ventricular septal defect 32.89 10.24 79 261175 4320 42355761
Therapy partial responder 32.59 10.24 45 261209 19976 42340105
BK virus infection 32.57 10.24 7 261247 8777 42351304
Body temperature decreased 32.30 10.24 174 261080 14239 42345842
Aspergillus infection 31.86 10.24 30 261224 15807 42344274
Joint laxity 31.85 10.24 24 261230 402 42359679
Localised infection 31.78 10.24 224 261030 20149 42339932
Hepatic failure 31.70 10.24 123 261131 37977 42322104
Aggression 31.59 10.24 151 261103 44012 42316069
Basal cell carcinoma 31.50 10.24 243 261011 22490 42337591
Tongue disorder 31.33 10.24 88 261166 5295 42354786
Drug ineffective for unapproved indication 30.64 10.24 162 261092 46001 42314080
Electrocardiogram QT prolonged 30.31 10.24 171 261083 47774 42312307
Exposure via breast milk 29.70 10.24 54 261200 2423 42357658
Inflammation 29.27 10.24 327 260927 33520 42326561
Toxic epidermal necrolysis 28.78 10.24 77 261177 26673 42333408
Pancytopenia 28.63 10.24 934 260320 116809 42243272
Bradycardia neonatal 28.25 10.24 38 261216 1310 42358771
Finger deformity 28.21 10.24 42 261212 1593 42358488
Influenza 27.96 10.24 536 260718 61639 42298442
Acute graft versus host disease 27.64 10.24 8 261246 8207 42351874
Haematocrit decreased 27.40 10.24 331 260923 34577 42325504
Drug intolerance 27.39 10.24 666 260588 79758 42280323
Suspected suicide 27.38 10.24 3 261251 6196 42353885
Acute chest syndrome 27.00 10.24 33 261221 1032 42359049
Plagiocephaly 26.52 10.24 25 261229 577 42359504
Dysgraphia 26.45 10.24 52 261202 2476 42357605
Respiratory disorder neonatal 26.28 10.24 45 261209 1925 42358156
Hypermobility syndrome 26.15 10.24 20 261234 343 42359738
Hyperglycaemia 26.14 10.24 169 261085 45690 42314391
Hepatic enzyme increased 26.10 10.24 410 260844 45374 42314707
Tendonitis 26.06 10.24 125 261129 9769 42350312
Anal fissure 26.06 10.24 81 261173 5158 42354923
Agranulocytosis 26.00 10.24 98 261156 30514 42329567
Mucormycosis 25.86 10.24 6 261248 7137 42352944
Developmental delay 25.81 10.24 59 261195 3123 42356958
Foetal growth restriction 25.65 10.24 81 261173 5202 42354879
Mucocutaneous ulceration 25.53 10.24 23 261231 500 42359581
Cytomegalovirus viraemia 25.53 10.24 16 261238 10361 42349720
Caesarean section 25.36 10.24 46 261208 2060 42358021
Cardiac murmur 25.17 10.24 149 261105 12626 42347455
Blood creatine phosphokinase increased 25.14 10.24 183 261071 48155 42311926
Joint range of motion decreased 24.98 10.24 104 261150 7649 42352432
Posterior reversible encephalopathy syndrome 24.96 10.24 25 261229 12796 42347285
Cystitis haemorrhagic 24.91 10.24 7 261247 7322 42352759
Congenital hand malformation 24.77 10.24 25 261229 629 42359452
No adverse event 24.76 10.24 139 261115 38882 42321199
Talipes 24.63 10.24 47 261207 2189 42357892
Polyarthritis 24.55 10.24 78 261176 5026 42355055
Red blood cell sedimentation rate increased 24.44 10.24 123 261131 9801 42350280
Vitamin D deficiency 24.24 10.24 106 261148 7967 42352114
Hyperkalaemia 24.23 10.24 347 260907 80111 42279970
Adenovirus infection 24.10 10.24 6 261248 6803 42353278
Polyomavirus-associated nephropathy 24.10 10.24 3 261251 5612 42354469
Proteinuria 24.09 10.24 67 261187 22916 42337165
Large for dates baby 23.88 10.24 29 261225 901 42359180
Cardiotoxicity 23.71 10.24 8 261246 7437 42352644
Acute graft versus host disease in skin 23.60 10.24 8 261246 7416 42352665
Ventricular tachycardia 23.44 10.24 100 261154 30060 42330021
Upper respiratory tract infection 23.41 10.24 376 260878 41797 42318284
Drug withdrawal syndrome neonatal 23.15 10.24 70 261184 4391 42355690
Catarrh 23.10 10.24 85 261169 5901 42354180
Frequent bowel movements 22.89 10.24 216 261038 21191 42338890
Wrong technique in product usage process 22.86 10.24 160 261094 42475 42317606
Drug level increased 22.82 10.24 83 261171 26117 42333964
Full blood count decreased 22.76 10.24 209 261045 20351 42339730
Pyrexia 22.74 10.24 2093 259161 391949 41968132
Astigmatism 22.69 10.24 34 261220 1297 42358784
Disseminated intravascular coagulation 22.63 10.24 77 261177 24717 42335364
Myoclonus 22.51 10.24 44 261210 17021 42343060
Pulmonary fibrosis 22.27 10.24 256 260998 26425 42333656
Agitation neonatal 22.26 10.24 35 261219 1393 42358688
Red blood cell count decreased 22.21 10.24 302 260952 32413 42327668
Cellulitis 22.19 10.24 514 260740 61071 42299010
Ultrasound antenatal screen 22.17 10.24 22 261232 542 42359539
Oropharyngeal pain 21.75 10.24 374 260880 42136 42317945
Drug withdrawal syndrome 21.72 10.24 64 261190 21485 42338596
Interstitial lung disease 21.70 10.24 344 260910 78118 42281963
Asphyxia 21.67 10.24 12 261242 8314 42351767
Diaphragmatic disorder 21.62 10.24 32 261222 1207 42358874
Cerebral haemorrhage 21.50 10.24 145 261109 38821 42321260
Ankylosing spondylitis 21.46 10.24 93 261161 6963 42353118
Thrombotic microangiopathy 21.39 10.24 36 261218 14746 42345335
Post procedural infection 21.37 10.24 81 261173 5704 42354377
Language disorder 21.32 10.24 47 261207 2428 42357653
Hydrops foetalis 21.28 10.24 27 261227 878 42359203
Osteonecrosis of jaw 21.13 10.24 54 261200 18995 42341086
Headache 20.90 10.24 1721 259533 237648 42122433
Skin cancer 20.88 10.24 131 261123 11331 42348750
Stevens-Johnson syndrome 20.85 10.24 68 261186 22110 42337971
Haematotoxicity 20.73 10.24 22 261232 10963 42349118
Trisomy 18 20.64 10.24 26 261228 839 42359242
Drug dependence 20.50 10.24 100 261154 28994 42331087
Foetal disorder 20.48 10.24 29 261225 1050 42359031
C-reactive protein increased 20.34 10.24 522 260732 63038 42297043
Cardio-respiratory arrest 20.17 10.24 246 261008 58390 42301691
Rebound effect 20.14 10.24 10 261244 7369 42352712
Fall 20.13 10.24 1684 259570 232836 42127245
Diffuse large B-cell lymphoma recurrent 20.05 10.24 3 261251 4883 42355198
Chronic graft versus host disease 20.03 10.24 6 261248 6019 42354062
Arthritis infective 19.98 10.24 63 261191 4043 42356038
Musculoskeletal pain 19.93 10.24 301 260953 33039 42327042
Eosinophilia 19.91 10.24 119 261135 32780 42327301
Back disorder 19.84 10.24 95 261159 7419 42352662
Systemic lupus erythematosus 19.84 10.24 111 261143 9213 42350868
Arthrodesis 19.82 10.24 21 261233 560 42359521
Hypotension 19.71 10.24 1337 259917 256294 42103787
Dyspraxia 19.62 10.24 19 261235 454 42359627
Knee deformity 19.53 10.24 24 261230 755 42359326
Nasal disorder 19.44 10.24 40 261214 1969 42358112
Hypocalcaemia 19.41 10.24 107 261147 30066 42330015
Tuberculosis 19.39 10.24 117 261137 9982 42350099
Pneumonia aspiration 19.22 10.24 205 261049 49873 42310208
Hyperbilirubinaemia neonatal 19.10 10.24 25 261229 839 42359242
Migraine 19.09 10.24 239 261015 25175 42334906
Maternal exposure before pregnancy 19.06 10.24 28 261226 1049 42359032
Burns second degree 19.04 10.24 81 261173 6015 42354066
Potentiating drug interaction 18.84 10.24 8 261246 6460 42353621
Gingival pain 18.66 10.24 102 261152 8392 42351689
Contusion 18.55 10.24 361 260893 41624 42318457
Septic shock 18.55 10.24 424 260830 91248 42268833
Exposure to toxic agent 18.53 10.24 4 261250 5000 42355081
Blood test abnormal 18.46 10.24 139 261115 12767 42347314
Joint stiffness 18.36 10.24 134 261120 12188 42347893
Pneumonia 18.21 10.24 2899 258355 419250 41940831
Radiation inflammation 18.19 10.24 27 261227 1021 42359060
Acute respiratory distress syndrome 18.17 10.24 109 261145 29999 42330082
Melaena 18.13 10.24 151 261103 38595 42321486
Selective eating disorder 18.12 10.24 36 261218 1728 42358353
Rash maculo-papular 18.08 10.24 145 261109 37358 42322723
Ear disorder 18.02 10.24 39 261215 1989 42358092
Parosmia 18.02 10.24 94 261160 7597 42352484
Motor developmental delay 17.98 10.24 22 261232 689 42359392
Hepatic encephalopathy 17.94 10.24 47 261207 16395 42343686
Loss of consciousness 17.89 10.24 430 260824 91924 42268157
Migraine with aura 17.89 10.24 25 261229 894 42359187
Mania 17.88 10.24 23 261231 10524 42349557
Thymus disorder 17.87 10.24 14 261240 249 42359832
Chronic obstructive pulmonary disease 17.82 10.24 510 260744 62604 42297477
Cleft lip and palate 17.62 10.24 25 261229 907 42359174
Epidural lipomatosis 17.61 10.24 36 261218 1764 42358317
Dyslexia 17.60 10.24 16 261238 352 42359729
Crohn's disease 17.58 10.24 49 261205 2935 42357146
Dysstasia 17.57 10.24 147 261107 13939 42346142
Spinal disorder 17.56 10.24 65 261189 4526 42355555
Temperature regulation disorder 17.51 10.24 28 261226 1131 42358950
Syringe issue 17.45 10.24 16 261238 8540 42351541
Status epilepticus 17.40 10.24 44 261210 15534 42344547
Hypotonia neonatal 17.35 10.24 32 261222 1452 42358629
Ankyloglossia congenital 17.23 10.24 16 261238 362 42359719
Obsessive-compulsive disorder 17.14 10.24 10 261244 6733 42353348
Withdrawal syndrome 17.08 10.24 41 261213 14734 42345347
Congenital foot malformation 17.03 10.24 17 261237 422 42359659
Hepatitis 16.91 10.24 98 261156 27202 42332879
Hyperammonaemia 16.91 10.24 14 261240 7852 42352229
Transient aphasia 16.78 10.24 20 261234 609 42359472
Colorectal cancer 16.78 10.24 5 261249 5033 42355048
Hallucination, visual 16.76 10.24 69 261185 20951 42339130
Serum ferritin increased 16.75 10.24 88 261166 7131 42352950
Anal fistula 16.73 10.24 79 261175 6134 42353947
Neuralgia 16.69 10.24 235 261019 25412 42334669
Heart rate irregular 16.69 10.24 161 261093 15889 42344192
Bronchopulmonary aspergillosis 16.63 10.24 62 261192 19367 42340714
Back pain 16.60 10.24 1044 260210 140732 42219349
Intervertebral disc degeneration 16.55 10.24 89 261165 7278 42352803
Hepatitis fulminant 16.37 10.24 5 261249 4954 42355127
Extrapyramidal disorder 16.36 10.24 49 261205 16363 42343718
Central nervous system mass 16.34 10.24 23 261231 828 42359253
Nephropathy toxic 16.26 10.24 51 261203 16787 42343294
Wall motion score index abnormal 16.26 10.24 23 261231 832 42359249
Intentional product misuse 16.25 10.24 274 260980 61626 42298455
Malignant melanoma 16.24 10.24 106 261148 9294 42350787
Mydriasis 16.07 10.24 18 261236 8752 42351329
Restlessness 16.05 10.24 109 261145 29140 42330941
Haemodynamic instability 16.03 10.24 33 261221 12524 42347557
Dystonia 16.00 10.24 34 261220 12756 42347325
Umbilical hernia 15.96 10.24 71 261183 5376 42354705
Intellectual disability 15.93 10.24 36 261218 1891 42358190
Tumour lysis syndrome 15.90 10.24 76 261178 22155 42337926
Skin abrasion 15.88 10.24 95 261159 8080 42352001
Progressive multifocal leukoencephalopathy 15.87 10.24 29 261225 11507 42348574
Bursitis 15.81 10.24 78 261176 6166 42353915
Miosis 15.79 10.24 37 261217 13409 42346672
Multiple-drug resistance 15.78 10.24 13 261241 7309 42352772
Seizure 15.74 10.24 592 260662 119969 42240112
Electrocardiogram QRS complex prolonged 15.73 10.24 8 261246 5815 42354266
Fistula discharge 15.70 10.24 26 261228 1082 42358999
Diabetic ketoacidosis 15.69 10.24 77 261177 22290 42337791
Spina bifida 15.68 10.24 16 261238 408 42359673
Lung neoplasm malignant 15.66 10.24 183 261071 18964 42341117
Victim of child abuse 15.65 10.24 27 261227 1162 42358919
Ear infection 15.64 10.24 133 261121 12671 42347410
Graft versus host disease 15.64 10.24 35 261219 12890 42347191
Cardiac septal defect 15.62 10.24 24 261230 936 42359145
Weight increased 15.50 10.24 810 260444 107173 42252908
Airway remodelling 15.36 10.24 23 261231 877 42359204
Medical device implantation 15.35 10.24 19 261235 602 42359479
Loss of personal independence in daily activities 15.32 10.24 407 260847 49409 42310672
Synovial cyst 15.32 10.24 43 261211 2586 42357495
Congenital anomaly 15.29 10.24 31 261223 1510 42358571
Multiple congenital abnormalities 15.26 10.24 18 261236 542 42359539
Cerebral infarction 15.26 10.24 120 261134 31049 42329032
Nodule 15.21 10.24 130 261124 12404 42347677
Cleft lip 15.18 10.24 14 261240 314 42359767
Lung hernia 15.11 10.24 8 261246 69 42360012
Transfusion-related circulatory overload 15.09 10.24 21 261233 748 42359333
Limb reduction defect 15.04 10.24 14 261240 318 42359763
Lacrimal disorder 14.96 10.24 14 261240 320 42359761
Euglycaemic diabetic ketoacidosis 14.96 10.24 8 261246 5652 42354429
Congenital bladder anomaly 14.96 10.24 13 261241 269 42359812
Hypopnoea 14.93 10.24 91 261163 7791 42352290
Device leakage 14.92 10.24 25 261229 10260 42349821
Oxygen saturation decreased 14.91 10.24 510 260744 64177 42295904
Red blood cell sedimentation rate 14.84 10.24 25 261229 1055 42359026
Swelling 14.81 10.24 441 260813 54444 42305637
Otitis media 14.81 10.24 53 261201 3630 42356451
Renal aplasia 14.80 10.24 21 261233 762 42359319
Thrombocytopenia 14.79 10.24 986 260268 189293 42170788
Weight decrease neonatal 14.72 10.24 14 261240 327 42359754
Neck mass 14.67 10.24 34 261220 1816 42358265
Hepatocellular injury 14.67 10.24 85 261169 23593 42336488
Iron deficiency 14.64 10.24 117 261137 10944 42349137
Sexual dysfunction 14.63 10.24 12 261242 6763 42353318
Pectus excavatum 14.57 10.24 12 261242 230 42359851
Drug-induced liver injury 14.56 10.24 157 261097 38116 42321965
Blister infected 14.54 10.24 17 261237 507 42359574
Muscle swelling 14.48 10.24 16 261238 448 42359633
Psychiatric decompensation 14.41 10.24 4 261250 4218 42355863
Mobility decreased 14.40 10.24 300 260954 35006 42325075
Hallucination, auditory 14.37 10.24 45 261209 14819 42345262
Hepatitis B 14.35 10.24 12 261242 6699 42353382
Hypertriglyceridaemia 14.34 10.24 25 261229 10101 42349980
Abnormal behaviour 14.31 10.24 99 261155 26352 42333729
Ulcer 14.29 10.24 159 261095 16282 42343799
Neck pain 14.26 10.24 261 260993 29753 42330328
Squamous cell carcinoma of lung 14.24 10.24 38 261216 2218 42357863
Nocardiosis 14.22 10.24 7 261247 5183 42354898
Mass 14.17 10.24 97 261157 8642 42351439
Gastrointestinal infection 14.17 10.24 80 261174 6663 42353418
Haemangioma congenital 14.15 10.24 17 261237 522 42359559
Tardive dyskinesia 14.06 10.24 13 261241 6911 42353170
Stiff person syndrome 13.98 10.24 11 261243 197 42359884
Atopy 13.97 10.24 23 261231 952 42359129
Blood parathyroid hormone decreased 13.93 10.24 31 261223 1612 42358469
Poor venous access 13.91 10.24 84 261170 7168 42352913
Stress 13.82 10.24 362 260892 43850 42316231
Hypertelorism 13.82 10.24 18 261236 601 42359480
Haemophagocytic lymphohistiocytosis 13.80 10.24 61 261193 18161 42341920
Erythema multiforme 13.79 10.24 25 261229 9952 42350129
Shock haemorrhagic 13.79 10.24 52 261202 16190 42343891
Nephrotic syndrome 13.79 10.24 20 261234 8698 42351383
Bronchitis 13.77 10.24 383 260871 46818 42313263
Hepatic steatosis 13.75 10.24 196 261058 21252 42338829
Endophthalmitis 13.71 10.24 5 261249 4428 42355653
Cholestasis 13.69 10.24 132 261122 32747 42327334
Vomiting 13.65 10.24 1561 259693 288162 42071919
Dry throat 13.64 10.24 44 261210 2858 42357223
Anaemia vitamin B12 deficiency 13.56 10.24 17 261237 546 42359535
Joint ankylosis 13.50 10.24 31 261223 1646 42358435
Nephrolithiasis 13.45 10.24 308 260946 36522 42323559
Scoliosis 13.45 10.24 46 261208 3080 42357001
Anaphylactic reaction 13.34 10.24 183 261071 42560 42317521
Granuloma skin 13.32 10.24 25 261229 1150 42358931
Glycosylated haemoglobin increased 13.31 10.24 38 261216 12886 42347195
Gamma-glutamyltransferase increased 13.30 10.24 131 261123 32366 42327715
Drug dose omission by device 13.25 10.24 10 261244 5876 42354205
Leukopenia 13.14 10.24 353 260901 74393 42285688
Immunodeficiency 13.08 10.24 83 261171 7207 42352874
Gait disturbance 13.04 10.24 730 260524 97270 42262811
Cough 12.99 10.24 1264 259990 176839 42183242
Steroid dependence 12.99 10.24 78 261176 6644 42353437
Asthenia 12.97 10.24 1936 259318 278857 42081224
Hydrocele 12.91 10.24 40 261214 2543 42357538
Cholelithiasis 12.90 10.24 208 261046 23138 42336943
Anti-cyclic citrullinated peptide antibody positive 12.88 10.24 33 261221 1879 42358202
Graft versus host disease in skin 12.87 10.24 8 261246 5204 42354877
Hypertransaminasaemia 12.87 10.24 23 261231 9204 42350877
Vein disorder 12.86 10.24 35 261219 2067 42358014
Oesophageal fibrosis 12.86 10.24 10 261244 176 42359905
Vitamin B12 deficiency 12.83 10.24 62 261192 4860 42355221
Immune effector cell-associated neurotoxicity syndrome 12.82 10.24 24 261230 9437 42350644
Ligament rupture 12.80 10.24 27 261227 1353 42358728
Septic arthritis staphylococcal 12.78 10.24 16 261238 513 42359568
Brain oedema 12.77 10.24 54 261200 16273 42343808
Accidental exposure to product 12.74 10.24 73 261181 20320 42339761
Disinhibition 12.73 10.24 4 261250 3891 42356190
Abortion spontaneous 12.73 10.24 14 261240 390 42359691
Bone cyst 12.72 10.24 30 261224 1621 42358460
Abdominal adhesions 12.72 10.24 31 261223 1711 42358370
Generalised tonic-clonic seizure 12.71 10.24 102 261152 26277 42333804
Unresponsive to stimuli 12.68 10.24 127 261127 31276 42328805
Immunosuppression 12.64 10.24 92 261162 8361 42351720
Tooth malformation 12.62 10.24 10 261244 181 42359900
Abdominal distension 12.60 10.24 549 260705 71186 42288895
Carcinoid tumour of the small bowel 12.59 10.24 14 261240 395 42359686
Arthritis bacterial 12.58 10.24 70 261184 5798 42354283
Transplant rejection 12.54 10.24 42 261212 13546 42346535
Tinnitus 12.50 10.24 248 261006 28690 42331391
Cataract 12.47 10.24 260 260994 30344 42329737
Hernia pain 12.45 10.24 12 261242 285 42359796
Arrhythmia 12.45 10.24 173 261081 40144 42319937
Disease recurrence 12.42 10.24 119 261135 29559 42330522
Pharyngeal disorder 12.38 10.24 21 261233 891 42359190
Hepatitis cholestatic 12.38 10.24 26 261228 9798 42350283
Torsade de pointes 12.37 10.24 21 261233 8573 42351508
Second primary malignancy 12.36 10.24 25 261229 9550 42350531
Spondyloarthropathy 12.35 10.24 21 261233 893 42359188
Fistula 12.34 10.24 87 261167 7825 42352256
Disability assessment scale score increased 12.34 10.24 14 261240 404 42359677
Hemiparaesthesia 12.26 10.24 10 261244 189 42359892
Tachypnoea 12.25 10.24 80 261174 21582 42338499
Neutropenia neonatal 12.25 10.24 21 261233 899 42359182
Lower respiratory tract congestion 12.25 10.24 29 261225 1571 42358510
Encephalopathy 12.18 10.24 179 261075 41154 42318927
Nerve compression 12.18 10.24 53 261201 3975 42356106
Mean cell volume increased 12.15 10.24 52 261202 3871 42356210
Inappropriate schedule of product administration 12.11 10.24 711 260543 95191 42264890
Kidney infection 12.10 10.24 77 261177 6693 42353388
Hepatitis E virus test positive 12.08 10.24 12 261242 296 42359785
Hypothermia 12.02 10.24 38 261216 12477 42347604
Somnolence 12.02 10.24 725 260529 140380 42219701
Gross motor delay 11.94 10.24 13 261241 358 42359723
Foetal distress syndrome 11.93 10.24 24 261230 1162 42358919
Enterocolitis 11.92 10.24 27 261227 9902 42350179
Attention deficit hyperactivity disorder 11.88 10.24 44 261210 3064 42357017
Hip arthroplasty 11.85 10.24 64 261190 5241 42354840
Subdural haematoma 11.83 10.24 88 261166 23050 42337031
Diverticulum 11.81 10.24 83 261171 7458 42352623
Tenderness 11.78 10.24 94 261160 8789 42351292
Pleural fibrosis 11.73 10.24 26 261228 1348 42358733
Product quality issue 11.73 10.24 63 261191 17819 42342262
Autoscopy 11.70 10.24 11 261243 253 42359828
Flatulence 11.70 10.24 218 261036 24934 42335147
Blood folate increased 11.70 10.24 12 261242 308 42359773
Hypoaesthesia 11.70 10.24 543 260711 70920 42289161
Adrenal insufficiency 11.69 10.24 68 261186 18856 42341225
Low set ears 11.67 10.24 15 261239 494 42359587
Hepatitis E antibody positive 11.60 10.24 11 261243 256 42359825
Gangrene neonatal 11.58 10.24 10 261244 205 42359876
Cystitis bacterial 11.54 10.24 10 261244 206 42359875
Spinal stenosis 11.54 10.24 73 261181 6333 42353748
Bronchiolitis 11.51 10.24 51 261203 3855 42356226
Patent ductus arteriosus 11.49 10.24 47 261207 3429 42356652
Arnold-Chiari malformation 11.46 10.24 13 261241 375 42359706
Pulmonary pain 11.44 10.24 28 261226 1550 42358531
Hypermetropia 11.42 10.24 15 261239 505 42359576
Neoplasm progression 11.42 10.24 118 261136 28882 42331199
Urticaria 11.41 10.24 356 260898 73680 42286401
Maternal exposure timing unspecified 11.41 10.24 13 261241 377 42359704
Acute graft versus host disease in intestine 11.33 10.24 5 261249 3946 42356135
Diverticular perforation 11.32 10.24 49 261205 3667 42356414
Microangiopathy 11.30 10.24 29 261225 1653 42358428
Polydactyly 11.28 10.24 24 261230 1210 42358871
Hyperbilirubinaemia 11.27 10.24 77 261177 20558 42339523
Catatonia 11.22 10.24 13 261241 6226 42353855
Sleep disorder due to a general medical condition 11.16 10.24 62 261192 17391 42342690
Ischaemic stroke 11.16 10.24 85 261169 22148 42337933
Venoocclusive disease 11.16 10.24 5 261249 3910 42356171
Pleuritic pain 11.15 10.24 78 261176 6999 42353082
Anuria 11.09 10.24 35 261219 11497 42348584
Alcohol poisoning 11.08 10.24 82 261172 7492 42352589
Hallucination 11.06 10.24 268 260986 57239 42302842
Urinary tract infection 11.05 10.24 728 260526 98556 42261525
Haemorrhage intracranial 11.04 10.24 61 261193 17131 42342950
Hand fracture 10.99 10.24 41 261213 2865 42357216
Steatorrhoea 10.97 10.24 19 261235 820 42359261
Hyperpyrexia 10.94 10.24 4 261250 3536 42356545
Analgesic therapy 10.93 10.24 73 261181 6451 42353630
Complications of transplanted kidney 10.92 10.24 10 261244 5340 42354741
Sleep disorder therapy 10.87 10.24 76 261178 6818 42353263
Developmental coordination disorder 10.85 10.24 10 261244 224 42359857
Cardiac failure chronic 10.82 10.24 27 261227 9574 42350507
Neutropenia 10.79 10.24 1064 260190 198367 42161714
Anal atresia 10.76 10.24 11 261243 281 42359800
Microcephaly 10.74 10.24 20 261234 914 42359167
Fear 10.74 10.24 33 261221 10932 42349149
Sickle cell anaemia 10.73 10.24 11 261243 282 42359799
Peritoneal dialysis complication 10.72 10.24 31 261223 1896 42358185
Psychomotor hyperactivity 10.72 10.24 33 261221 10925 42349156
Asymptomatic bacteriuria 10.71 10.24 10 261244 228 42359853
Hypoxia 10.65 10.24 336 260918 69450 42290631
Oliguria 10.64 10.24 26 261228 9287 42350794
Muscle rigidity 10.64 10.24 38 261216 12021 42348060
Acute generalised exanthematous pustulosis 10.62 10.24 23 261231 8572 42351509
Skin injury 10.61 10.24 38 261216 2603 42357478
C-reactive protein decreased 10.60 10.24 34 261220 2202 42357879
Respiratory rate increased 10.55 10.24 109 261145 10953 42349128
Vitamin B12 decreased 10.54 10.24 28 261226 1630 42358451
Tinea pedis 10.50 10.24 32 261222 2016 42358065
Red blood cell sedimentation rate abnormal 10.49 10.24 49 261205 3787 42356294
Muscle twitching 10.47 10.24 37 261217 11743 42348338
Injection site haemorrhage 10.43 10.24 114 261140 11622 42348459
Strongyloidiasis 10.39 10.24 4 261250 3427 42356654
Vascular insufficiency 10.39 10.24 12 261242 353 42359728
Blood albumin decreased 10.38 10.24 142 261112 15260 42344821
Drug eruption 10.31 10.24 91 261163 22984 42337097
Blood insulin increased 10.29 10.24 12 261242 357 42359724
Coccydynia 10.28 10.24 16 261238 631 42359450
Injection site bruising 10.26 10.24 112 261142 11413 42348668

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
Toxicity to various agents 1435.94 10.20 1156 926611 479399 109182133
Completed suicide 1390.12 10.20 192 927575 242189 109419343
Joint swelling 1002.52 10.20 6753 921014 436092 109225440
Arthropathy 934.08 10.20 4823 922944 282699 109378833
Systemic lupus erythematosus 922.40 10.20 4402 923365 249936 109411596
Drug interaction 901.51 10.20 1770 925997 498413 109163119
Pemphigus 886.91 10.20 3860 923907 210710 109450822
Rheumatoid arthritis 867.57 10.20 4870 922897 294743 109366789
Hand deformity 855.67 10.20 3868 923899 214638 109446894
Synovitis 853.27 10.20 4544 923223 269548 109391984
Glossodynia 812.56 10.20 3853 923914 218151 109443381
Drug abuse 809.42 10.20 241 927526 177170 109484362
Infusion related reaction 692.06 10.20 5516 922251 375646 109285886
Wound 686.57 10.20 3823 923944 230614 109430918
Intentional overdose 686.19 10.20 138 927629 132363 109529169
Anti-cyclic citrullinated peptide antibody positive 669.10 10.20 3163 924604 178821 109482711
Pain 657.27 10.20 11451 916316 943504 108718028
Pericarditis 631.53 10.20 3558 924209 215556 109445976
Abdominal discomfort 622.73 10.20 5526 922241 388332 109273200
Acute kidney injury 614.87 10.20 2990 924777 632440 109029092
Arthralgia 606.52 10.20 9540 918227 770092 108891440
Maternal exposure during pregnancy 591.61 10.20 3913 923854 250970 109410562
Swelling 567.09 10.20 4949 922818 346092 109315440
Febrile neutropenia 542.08 10.20 1154 926613 315613 109345919
Alopecia 539.53 10.20 5045 922722 359708 109301824
Duodenal ulcer perforation 538.33 10.20 2925 924842 174775 109486757
Helicobacter infection 525.74 10.20 2956 924811 178921 109482611
Psoriatic arthropathy 517.54 10.20 3119 924648 193642 109467890
Hepatic enzyme increased 498.09 10.20 4485 923282 316407 109345125
Contraindicated product administered 493.72 10.20 3671 924096 244596 109416936
Therapeutic product effect decreased 487.78 10.20 3616 924151 240700 109420832
Death 458.18 10.20 3709 924058 695160 108966372
Nasopharyngitis 455.85 10.20 5187 922580 389174 109272358
Discomfort 440.68 10.20 3199 924568 211508 109450024
Suicide attempt 415.75 10.20 173 927594 103221 109558311
Impaired healing 409.47 10.20 2941 924826 193776 109467756
Rheumatoid factor positive 406.14 10.20 2178 925589 129462 109532070
Musculoskeletal stiffness 392.54 10.20 3828 923939 275994 109385538
Cardiac arrest 387.07 10.20 659 927108 196094 109465438
Folliculitis 369.09 10.20 2541 925226 165112 109496420
Sinusitis 367.65 10.20 3957 923810 292731 109368801
Irritable bowel syndrome 356.25 10.20 2480 925287 161735 109499797
Lower respiratory tract infection 351.40 10.20 3347 924420 239759 109421773
Peripheral swelling 340.14 10.20 5014 922753 399020 109262512
Fibromyalgia 335.54 10.20 2520 925247 168389 109493143
Muscle injury 332.67 10.20 2172 925595 138635 109522897
Rhabdomyolysis 330.64 10.20 313 927454 120088 109541444
Disease progression 329.21 10.20 1003 926764 243031 109418501
Blister 324.43 10.20 3122 924645 224254 109437278
Malignant neoplasm progression 314.55 10.20 617 927150 173950 109487582
Exposure during pregnancy 312.68 10.20 2440 925327 164984 109496548
Lactic acidosis 311.06 10.20 197 927570 92614 109568918
Neutropenia 301.26 10.20 1873 925894 372747 109288785
Drug intolerance 301.02 10.20 4937 922830 401575 109259957
C-reactive protein abnormal 296.33 10.20 1984 925783 127711 109533821
Rheumatic fever 286.00 10.20 1885 925882 120694 109540838
Sleep disorder due to general medical condition, insomnia type 285.51 10.20 1687 926080 103956 109557576
Cardiac failure 284.30 10.20 729 927038 186897 109474635
Hypersensitivity 281.38 10.20 4858 922909 399140 109262392
Hepatic function abnormal 281.23 10.20 203 927564 89092 109572440
Bradycardia 279.04 10.20 551 927216 154966 109506566
Depressed level of consciousness 273.44 10.20 323 927444 111955 109549577
Weight increased 271.64 10.20 4988 922779 414656 109246876
Drug reaction with eosinophilia and systemic symptoms 271.37 10.20 177 927590 81918 109579614
Osteoarthritis 271.15 10.20 2529 925238 180094 109481438
Renal failure 264.79 10.20 991 926776 225583 109435949
Ill-defined disorder 258.95 10.20 2223 925544 154630 109506902
Coma 258.29 10.20 367 927400 117502 109544030
Serotonin syndrome 257.86 10.20 87 927680 59066 109602466
Renal impairment 257.36 10.20 770 926997 187675 109473857
Respiratory failure 250.87 10.20 943 926824 214389 109447143
Electrocardiogram QT prolonged 238.02 10.20 340 927427 108620 109552912
Hypotension 234.97 10.20 3041 924726 520808 109140724
Bursitis 234.08 10.20 1878 925889 128040 109533492
Myelosuppression 231.22 10.20 270 927497 94070 109567462
Multiple organ dysfunction syndrome 225.57 10.20 595 927172 151115 109510417
Angioedema 223.54 10.20 299 927468 98201 109563331
Contusion 219.88 10.20 2955 924812 230406 109431126
Type 2 diabetes mellitus 218.51 10.20 2362 925405 174870 109486662
Drug resistance 217.63 10.20 100 927667 56274 109605258
Swollen joint count increased 217.12 10.20 1322 926445 82339 109579193
Stomatitis 212.23 10.20 3315 924452 266927 109394605
Respiratory arrest 212.07 10.20 112 927655 58187 109603345
Inflammation 211.46 10.20 2516 925251 190722 109470810
Treatment failure 205.78 10.20 3369 924398 273865 109387667
Hypoglycaemia 204.28 10.20 416 927351 115688 109545844
Blood cholesterol increased 203.99 10.20 2410 925357 182375 109479157
Sopor 202.32 10.20 32 927735 36514 109625018
Overdose 200.45 10.20 1145 926622 232649 109428883
Cardio-respiratory arrest 197.11 10.20 423 927344 115413 109546119
Fatigue 196.82 10.20 12257 915510 1203701 108457831
Hyponatraemia 196.41 10.20 1048 926719 216605 109444927
Altered state of consciousness 196.30 10.20 120 927647 57506 109604026
Cytokine release syndrome 192.74 10.20 183 927584 70123 109591409
Joint range of motion decreased 189.82 10.20 1705 926062 120127 109541405
Agitation 189.74 10.20 416 927351 112635 109548897
Cytomegalovirus infection 188.79 10.20 111 927656 54333 109607199
Metabolic acidosis 186.24 10.20 345 927422 99399 109562133
Drug ineffective for unapproved indication 185.62 10.20 363 927404 102475 109559057
Product use issue 185.44 10.20 3658 924109 308037 109353495
Tachycardia 184.22 10.20 1129 926638 225516 109436016
Sickle cell anaemia with crisis 182.99 10.20 305 927462 9240 109652292
Facet joint syndrome 178.41 10.20 1407 926360 95421 109566111
Mobility decreased 177.94 10.20 2890 924877 234532 109427000
Arthritis 175.49 10.20 2164 925603 165422 109496110
Blood pressure systolic abnormal 171.19 10.20 528 927239 24322 109637210
Somnolence 170.78 10.20 1632 926135 295817 109365715
Knee arthroplasty 170.23 10.20 1029 926738 63919 109597613
Grip strength decreased 169.78 10.20 1204 926563 78970 109582562
Hepatic failure 169.24 10.20 196 927571 68543 109592989
Lip dry 168.59 10.20 1425 926342 98658 109562874
Hyperkalaemia 168.53 10.20 579 927188 135217 109526315
Red blood cell sedimentation rate abnormal 167.21 10.20 519 927248 23990 109637542
Blood pressure diastolic abnormal 163.65 10.20 533 927234 25282 109636250
Sedation 159.67 10.20 210 927557 69473 109592059
Psoriasis 159.44 10.20 1837 925930 138156 109523376
Blood pressure fluctuation 156.90 10.20 1121 926646 73703 109587829
Shock 152.21 10.20 135 927632 53453 109608079
Poisoning 151.30 10.20 30 927737 29075 109632457
Musculoskeletal pain 151.27 10.20 2265 925502 180758 109480774
Hip arthroplasty 150.58 10.20 891 926876 54922 109606610
Infection 150.21 10.20 4041 923726 358159 109303373
Intentional self-injury 149.84 10.20 63 927704 37366 109624166
Anaphylactic shock 146.24 10.20 130 927637 51416 109610116
Pregnancy 146.09 10.20 828 926939 50239 109611293
Intentional product use issue 145.26 10.20 2903 924864 245003 109416529
Hyperglycaemia 144.53 10.20 311 927456 84779 109576753
Thrombocytopenia 143.05 10.20 2062 925705 346823 109314709
Sepsis 141.22 10.20 1915 925852 325431 109336101
Injury 138.52 10.20 2173 925594 175092 109486440
Seizure 138.06 10.20 1188 926579 219997 109441535
Ventricular tachycardia 137.27 10.20 130 927637 49879 109611653
Night sweats 136.35 10.20 1721 926046 132262 109529270
Blood pressure systolic increased 136.28 10.20 1175 926592 81816 109579716
Obesity 134.30 10.20 1499 926268 111852 109549680
Syncope 132.21 10.20 1075 926692 201461 109460071
Neurotoxicity 130.23 10.20 98 927669 42109 109619423
Immunodeficiency 129.66 10.20 657 927110 38181 109623351
Hypokalaemia 129.12 10.20 947 926820 181501 109480031
Disseminated intravascular coagulation 125.94 10.20 97 927670 41189 109620343
Abortion spontaneous 125.21 10.20 595 927172 33687 109627845
Pain in extremity 124.18 10.20 5132 922635 481986 109179546
Drug use disorder 123.11 10.20 7 927760 18067 109643465
Anaemia 122.29 10.20 3574 924193 543512 109118020
Hypoxia 122.22 10.20 614 927153 128901 109532631
Encephalopathy 121.90 10.20 316 927451 80739 109580793
Live birth 121.64 10.20 998 926769 68486 109593046
Peripheral venous disease 121.33 10.20 1158 926609 82959 109578573
Suicidal ideation 120.32 10.20 395 927372 93542 109567990
Rash 119.82 10.20 8206 919561 812758 108848774
Gastrointestinal disorder 119.45 10.20 2764 925003 239188 109422344
Hepatocellular injury 118.73 10.20 150 927617 50492 109611040
Wound infection 118.09 10.20 1284 926483 95181 109566351
Leukopenia 115.81 10.20 751 927016 148040 109513492
Cholestasis 114.47 10.20 230 927537 64288 109597244
Suspected suicide 113.27 10.20 3 927764 15196 109646336
Neuroleptic malignant syndrome 113.14 10.20 73 927694 33986 109627546
Red blood cell sedimentation rate increased 111.48 10.20 1075 926692 77227 109584305
Sciatica 110.86 10.20 1225 926542 91174 109570358
Acute hepatic failure 110.83 10.20 86 927681 36382 109625150
C-reactive protein increased 107.42 10.20 2489 925278 215430 109446102
Cerebral haemorrhage 107.42 10.20 241 927526 64727 109596805
Road traffic accident 104.40 10.20 1368 926399 106030 109555502
Deep vein thrombosis postoperative 104 10.20 852 926915 58439 109603093
Blood creatine phosphokinase increased 103.80 10.20 293 927474 72784 109588748
Joint effusion 103.57 10.20 398 927369 20507 109641025
Neuropathy peripheral 103.53 10.20 982 926785 178295 109483237
Juvenile idiopathic arthritis 103.40 10.20 183 927584 5824 109655708
Mydriasis 103.02 10.20 29 927738 22128 109639404
Hypoaesthesia 101.37 10.20 3399 924368 310824 109350708
Off label use 101.14 10.20 11034 916733 1489151 108172381
Myocardial infarction 101.02 10.20 1076 926691 191007 109470525
Palmar-plantar erythrodysaesthesia syndrome 100.96 10.20 117 927650 40908 109620624
Thrombotic microangiopathy 100.26 10.20 60 927707 29089 109632443
Aggression 99.24 10.20 218 927549 58992 109602540
Dry mouth 98.93 10.20 2285 925482 197663 109463869
Myoclonus 98.79 10.20 79 927688 32919 109628613
Interstitial lung disease 98.20 10.20 724 927043 138610 109522922
Blood creatinine increased 98.01 10.20 1020 926747 181869 109479663
Liver injury 97.15 10.20 1788 925979 148625 109512907
Psychotic disorder 96.13 10.20 175 927592 50762 109610770
Prescribed overdose 95.59 10.20 1140 926627 86441 109575091
Breast cancer stage III 95.41 10.20 1050 926717 78067 109583465
Post transplant lymphoproliferative disorder 95.27 10.20 10 927757 15603 109645929
Coeliac disease 95.21 10.20 655 927112 42532 109619000
Aspergillus infection 94.97 10.20 48 927719 25568 109635964
Venoocclusive liver disease 94.72 10.20 9 927758 15198 109646334
Tremor 94.57 10.20 1163 926604 201069 109460463
Torsade de pointes 93.80 10.20 36 927731 22564 109638968
Foot deformity 92.90 10.20 711 927056 47769 109613763
Septic shock 92.62 10.20 859 926908 156669 109504863
Disability assessment scale score increased 92.17 10.20 144 927623 4126 109657406
Hypothermia 92.08 10.20 53 927714 26249 109635283
Therapy partial responder 91.96 10.20 105 927662 36956 109624576
Neutrophil count decreased 91.80 10.20 615 927152 120326 109541206
Cerebral infarction 91.79 10.20 185 927582 51653 109609879
Neoplasm progression 91.74 10.20 259 927508 64336 109597196
Hallucination 91.12 10.20 489 927278 100943 109560589
Posterior reversible encephalopathy syndrome 90.64 10.20 90 927677 33771 109627761
Disorientation 89.93 10.20 298 927469 70373 109591159
Drug dependence 89.87 10.20 177 927590 49843 109611689
Cytomegalovirus infection reactivation 89.03 10.20 22 927745 18311 109643221
Product use in unapproved indication 88.41 10.20 2970 924797 444407 109217125
Miosis 88 10.20 37 927730 21946 109639586
Disturbance in attention 87.73 10.20 249 927518 61746 109599786
Loss of consciousness 87.66 10.20 1140 926627 195166 109466366
Proteinuria 87.25 10.20 125 927642 39893 109621639
Injection site reaction 86.76 10.20 1135 926632 87935 109573597
Drug level increased 86.48 10.20 168 927599 47551 109613981
Joint stiffness 86.00 10.20 903 926864 66340 109595192
Bronchopulmonary aspergillosis 85.09 10.20 75 927692 29788 109631744
Dehydration 85.06 10.20 1743 926024 277768 109383764
Eosinophilia 84.74 10.20 229 927538 57707 109603825
Akathisia 84.15 10.20 20 927747 17093 109644439
Anaphylactic reaction 83.90 10.20 587 927180 113713 109547819
Autoimmune disorder 83.58 10.20 879 926888 64604 109596928
Diabetic ketoacidosis 83.45 10.20 140 927627 41918 109619614
Heart rate decreased 82.48 10.20 1059 926708 81697 109579835
Pathogen resistance 82.41 10.20 23 927744 17649 109643883
Status epilepticus 82.14 10.20 86 927681 31485 109630047
Haematotoxicity 81.99 10.20 37 927730 21045 109640487
Lower limb fracture 81.89 10.20 980 926787 74368 109587164
Exposure to toxic agent 81.73 10.20 7 927760 12851 109648681
Extrapyramidal disorder 81.65 10.20 73 927694 28794 109632738
Gait inability 81.50 10.20 1602 926165 134774 109526758
Melaena 80.09 10.20 301 927466 68456 109593076
Respiratory distress 79.91 10.20 302 927465 68572 109592960
Blood pressure diastolic decreased 79.55 10.20 545 927222 35340 109626192
Acute respiratory distress syndrome 79.53 10.20 208 927559 52990 109608542
No adverse event 79.19 10.20 334 927433 73505 109588027
Adverse event 79.05 10.20 1318 926449 107491 109554041
Bone erosion 77.94 10.20 660 927107 45711 109615821
Cardiac failure congestive 77.73 10.20 850 926917 150150 109511382
Dislocation of vertebra 77.61 10.20 630 927137 43091 109618441
Gamma-glutamyltransferase increased 77.00 10.20 260 927507 61049 109600483
Acute graft versus host disease 76.70 10.20 9 927758 12872 109648660
Ejection fraction decreased 76.65 10.20 141 927626 40739 109620793
Pulmonary fibrosis 76.34 10.20 1242 926525 100800 109560732
Drug withdrawal syndrome 76.13 10.20 126 927641 37928 109623604
BK virus infection 75.98 10.20 10 927757 13096 109648436
Immune reconstitution inflammatory syndrome 75.88 10.20 21 927746 16205 109645327
Asphyxia 75.27 10.20 14 927753 14201 109647331
Loss of personal independence in daily activities 74.99 10.20 1717 926050 148303 109513229
Dysarthria 74.75 10.20 407 927360 83714 109577818
Unresponsive to stimuli 74.47 10.20 279 927488 63511 109598021
Blood pressure diastolic increased 74.28 10.20 334 927433 18473 109643059
Atrial fibrillation 74.09 10.20 1418 926349 228224 109433308
Substance abuse 73.49 10.20 9 927758 12454 109649078
Agranulocytosis 73.48 10.20 268 927499 61492 109600040
Restlessness 73.13 10.20 235 927532 56024 109605508
Stevens-Johnson syndrome 71.95 10.20 181 927586 46720 109614812
Adjustment disorder with depressed mood 71.87 10.20 621 927146 43262 109618270
Haemophagocytic lymphohistiocytosis 71.38 10.20 96 927671 31463 109630069
Sleep disorder 70.32 10.20 2173 925594 196471 109465061
Temperature regulation disorder 70.06 10.20 252 927515 12574 109648958
Blood bilirubin increased 70.05 10.20 363 927404 75609 109585923
Myalgia 69.97 10.20 1379 926388 221002 109440530
Wrong technique in product usage process 69.94 10.20 437 927330 86911 109574621
Dystonia 69.75 10.20 68 927699 25737 109635795
Pancreatitis acute 69.46 10.20 265 927502 60009 109601523
Ear infection 68.65 10.20 817 926950 61915 109599617
Abnormal behaviour 68.55 10.20 140 927627 38899 109622633
Enthesopathy 68.02 10.20 245 927522 12233 109649299
Tachypnoea 67.72 10.20 143 927624 39252 109622280
Osteoporosis 66.77 10.20 1065 926702 86087 109575445
Dysphagia 66.02 10.20 899 926868 152701 109508831
Hypercholesterolaemia 65.50 10.20 1099 926668 89738 109571794
Psychomotor hyperactivity 65.28 10.20 45 927722 20232 109641300
Inappropriate antidiuretic hormone secretion 65.04 10.20 115 927652 33736 109627796
Hyperhidrosis 64.96 10.20 1142 926625 186156 109475376
Transplant rejection 64.96 10.20 66 927701 24501 109637031
Condition aggravated 64.71 10.20 7076 920691 727760 108933772
Arrhythmia 64.40 10.20 332 927435 69243 109592289
Rash maculo-papular 64.37 10.20 362 927405 73860 109587672
Osteonecrosis of jaw 64.22 10.20 198 927569 47819 109613713
Blood glucose increased 63.82 10.20 757 927010 131739 109529793
Hypomagnesaemia 63.55 10.20 275 927492 60095 109601437
Cytomegalovirus viraemia 63.33 10.20 35 927732 17729 109643803
Toxic epidermal necrolysis 63.08 10.20 253 927514 56474 109605058
Withdrawal syndrome 62.68 10.20 104 927663 31276 109630256
Onychomycosis 62.44 10.20 544 927223 37987 109623545
Onychomadesis 62.11 10.20 621 927146 45042 109616490
Polyarthritis 62.04 10.20 319 927448 18644 109642888
Mucormycosis 61.88 10.20 8 927759 10620 109650912
Cognitive disorder 61.52 10.20 455 927312 87056 109574476
Joint destruction 61.49 10.20 217 927550 10726 109650806
Hallucination, visual 61.41 10.20 152 927615 39453 109622079
Upper respiratory tract infection 61.33 10.20 1489 926278 129839 109531693
Coagulopathy 61.12 10.20 160 927607 40751 109620781
Clostridium difficile colitis 60.36 10.20 178 927589 43600 109617932
Respiratory depression 60.33 10.20 110 927657 31891 109629641
Graft versus host disease 60.19 10.20 42 927725 18764 109642768
Tumour lysis syndrome 59.76 10.20 104 927663 30697 109630835
Muscle rigidity 59.71 10.20 68 927699 23963 109637569
Graft versus host disease in gastrointestinal tract 59.50 10.20 4 927763 8964 109652568
Ascites 59.44 10.20 495 927272 92313 109569219
Ischaemic stroke 58.92 10.20 165 927602 41098 109620434
Face oedema 58.79 10.20 120 927647 33349 109628183
Pulmonary oedema 58.68 10.20 550 927217 100109 109561423
Dyskinesia 58.12 10.20 228 927539 51218 109610314
Acute graft versus host disease in skin 58.12 10.20 10 927757 10730 109650802
Platelet count decreased 57.97 10.20 1480 926287 228963 109432569
Adenovirus infection 57.85 10.20 11 927756 10983 109650549
Accidental exposure to product 57.54 10.20 220 927547 49788 109611744
Rheumatoid nodule 57.33 10.20 328 927439 19968 109641564
Cardiogenic shock 56.88 10.20 267 927500 57071 109604461
Polyomavirus-associated nephropathy 56.41 10.20 3 927764 8198 109653334
Acute generalised exanthematous pustulosis 56.38 10.20 59 927708 21605 109639927
Laryngitis 56.35 10.20 574 927193 41837 109619695
Lung disorder 56.34 10.20 1941 925826 178106 109483426
Unintentional medical device removal 56.33 10.20 5 927762 8918 109652614
Mania 55.98 10.20 55 927712 20741 109640791
Exostosis 55.90 10.20 611 927156 45345 109616187
Hyperbilirubinaemia 55.56 10.20 108 927659 30563 109630969
Nausea 55.41 10.20 9319 918448 1226371 108435161
Ear pain 55.11 10.20 686 927081 52540 109608992
Angina pectoris 55.02 10.20 302 927465 61993 109599539
Cardiotoxicity 54.96 10.20 37 927730 16844 109644688
Nail disorder 54.64 10.20 734 927033 57201 109604331
Second primary malignancy 54.41 10.20 43 927724 18025 109643507
Haemorrhage intracranial 54.24 10.20 100 927667 28869 109632663
Toxic skin eruption 54.21 10.20 92 927675 27423 109634109
C-reactive protein 53.81 10.20 437 927330 29894 109631638
Urinary retention 53.55 10.20 353 927414 69330 109592202
Body temperature decreased 53.51 10.20 509 927258 36426 109625106
Disease recurrence 53.50 10.20 295 927472 60489 109601043
Paradoxical drug reaction 53.44 10.20 9 927758 9808 109651724
Metastases to liver 53.17 10.20 138 927629 35248 109626284
Carpal tunnel syndrome 52.88 10.20 348 927419 22262 109639270
Cytopenia 52.88 10.20 108 927659 30008 109631524
Food allergy 52.87 10.20 317 927450 19631 109641901
Hemiplegia 52.86 10.20 68 927699 22714 109638818
General physical health deterioration 52.84 10.20 4198 923569 421097 109240435
Retinitis 52.69 10.20 457 927310 31870 109629662
Bronchospasm 52.62 10.20 109 927658 30130 109631402
Haemoptysis 52.58 10.20 366 927401 70988 109590544
Localised infection 52.21 10.20 572 927195 42476 109619056
Joint laxity 51.98 10.20 83 927684 2424 109659108
Epstein-Barr virus infection 51.09 10.20 49 927718 18689 109642843
Aphasia 51.02 10.20 288 927479 58709 109602823
Blepharospasm 50.94 10.20 693 927074 54158 109607374
Schizophrenia 50.79 10.20 65 927702 21761 109639771
Parkinsonism 50.68 10.20 67 927700 22120 109639412
Rebound effect 50.19 10.20 31 927736 14775 109646757
Shock haemorrhagic 50.18 10.20 95 927672 27152 109634380
Chronic kidney disease 50.18 10.20 404 927363 75887 109585645
Brain oedema 50.08 10.20 117 927650 30981 109630551
Generalised tonic-clonic seizure 50.00 10.20 262 927505 54418 109607114
Migraine 49.88 10.20 1835 925932 169817 109491715
Hyperthermia 49.87 10.20 63 927704 21209 109640323
Sinus tachycardia 49.75 10.20 198 927569 44295 109617237
Mental status changes 49.66 10.20 404 927363 75718 109585814
Wheezing 49.66 10.20 2618 925149 252612 109408920
Acute myocardial infarction 49.16 10.20 457 927310 83320 109578212
Irritability 48.98 10.20 220 927547 47589 109613943
Haemodynamic instability 48.42 10.20 73 927694 22815 109638717
Acute myeloid leukaemia 48.28 10.20 161 927606 37949 109623583
Intentional product misuse 48.13 10.20 804 926963 132100 109529432
Erythema multiforme 47.90 10.20 64 927703 21033 109640499
Hepatotoxicity 47.80 10.20 323 927444 63077 109598455
Gastrointestinal haemorrhage 47.73 10.20 1041 926726 164477 109497055
Anuria 47.40 10.20 82 927685 24259 109637273
Chest discomfort 47.13 10.20 1104 926663 172744 109488788
Caesarean section 47.00 10.20 235 927532 13582 109647950
Metastases to bone 46.64 10.20 123 927644 31249 109630283
Chronic graft versus host disease 46.61 10.20 11 927756 9446 109652086
Tenosynovitis 46.55 10.20 264 927503 16019 109645513
Bradyphrenia 46.53 10.20 20 927747 11708 109649824
Subdural haematoma 46.18 10.20 154 927613 36300 109625232
Ejection fraction 45.77 10.20 86 927681 2869 109658663
Sensitisation 45.71 10.20 105 927662 4046 109657486
Drug dose omission by device 45.70 10.20 33 927734 14483 109647049
Colitis ulcerative 45.61 10.20 907 926860 76456 109585076
X-ray abnormal 45.55 10.20 505 927262 37612 109623920
Aspartate aminotransferase increased 45.52 10.20 1008 926759 158928 109502604
Myocarditis 45.32 10.20 117 927650 29938 109631594
Polyneuropathy 44.98 10.20 129 927638 31883 109629649
Polycystic ovaries 44.96 10.20 114 927653 4682 109656850
Device difficult to use 44.81 10.20 55 927712 18750 109642782
Speech disorder 44.78 10.20 317 927450 61252 109600280
Dyspnoea 44.71 10.20 8394 919373 1098478 108563054
Gestational diabetes 44.55 10.20 150 927617 7239 109654293
Pleural effusion 44.50 10.20 1142 926625 176567 109484965
Multiple-drug resistance 44.46 10.20 28 927739 13207 109648325
Injection site erythema 44.33 10.20 1069 926698 93107 109568425
Leukocytosis 44.29 10.20 267 927500 53561 109607971
Lupus vulgaris 44.26 10.20 457 927310 33426 109628106
Labelled drug-drug interaction medication error 44.23 10.20 114 927653 29188 109632344
Haematoma 44.05 10.20 298 927469 58178 109603354
Pyrexia 44.04 10.20 6739 921028 891526 108770006
Cystitis haemorrhagic 43.60 10.20 24 927743 12185 109649347
Maternal exposure timing unspecified 43.57 10.20 314 927453 20699 109640833
Finger deformity 43.55 10.20 447 927320 32645 109628887
Acute respiratory failure 43.53 10.20 412 927355 74848 109586684
Immune effector cell-associated neurotoxicity syndrome 43.49 10.20 36 927731 14746 109646786
Hemiparesis 43.21 10.20 205 927562 43698 109617834
Nodule 43.05 10.20 441 927326 32190 109629342
Coronary artery disease 42.96 10.20 389 927378 71301 109590231
Pulmonary alveolar haemorrhage 42.89 10.20 64 927703 20086 109641446
Febrile bone marrow aplasia 42.77 10.20 50 927717 17415 109644117
Tardive dyskinesia 42.58 10.20 31 927736 13548 109647984
Enterocolitis 42.50 10.20 58 927709 18891 109642641
Pneumonia aspiration 42.30 10.20 456 927311 80777 109580755
Oliguria 41.95 10.20 57 927710 18600 109642932
Lupus-like syndrome 41.91 10.20 525 927242 40267 109621265
Foetal death 41.90 10.20 254 927513 15791 109645741
Graft versus host disease in skin 41.88 10.20 9 927758 8245 109653287
Electrocardiogram QRS complex prolonged 41.78 10.20 29 927738 12992 109648540
Basal cell carcinoma 41.65 10.20 571 927196 44699 109616833
Jaundice 41.63 10.20 308 927459 58928 109602604
Ileus 41.60 10.20 126 927641 30603 109630929
Asthma-chronic obstructive pulmonary disease overlap syndrome 41.60 10.20 3 927764 6341 109655191
Tenderness 41.33 10.20 403 927364 29034 109632498
Diffuse large B-cell lymphoma recurrent 41.24 10.20 3 927764 6296 109655236
Constipation 41.18 10.20 2519 925248 355267 109306265
Stress cardiomyopathy 41.18 10.20 43 927724 15763 109645769
Prescribed underdose 41.11 10.20 772 926995 64402 109597130
Palpitations 40.97 10.20 1019 926748 158193 109503339
Diabetes insipidus 40.63 10.20 4 927763 6566 109654966
Hepatic cirrhosis 40.59 10.20 795 926972 66831 109594701
Nocardiosis 40.45 10.20 7 927760 7479 109654053
Hepatitis B reactivation 40.43 10.20 7 927760 7477 109654055
Hypocalcaemia 40.34 10.20 352 927415 65014 109596518
Blood alkaline phosphatase increased 40.31 10.20 390 927377 70545 109590987
Respiratory acidosis 40.27 10.20 34 927733 13792 109647740
Mucosal inflammation 40.12 10.20 566 927201 95575 109565957
Jaundice cholestatic 40.06 10.20 38 927729 14570 109646962
Cardiac failure acute 40.06 10.20 89 927678 23989 109637543
Bacteraemia 39.95 10.20 201 927566 42189 109619343
Transaminases increased 39.73 10.20 340 927427 63050 109598482
Pneumothorax 39.46 10.20 157 927610 35128 109626404
Vision blurred 39.38 10.20 804 926963 128218 109533314
Sinus bradycardia 39.13 10.20 122 927645 29361 109632171
Maternal exposure before pregnancy 39.06 10.20 142 927625 7123 109654409
Joint dislocation 39.06 10.20 449 927318 33741 109627791
Anti-cyclic citrullinated peptide antibody 38.92 10.20 294 927473 19670 109641862
Acute coronary syndrome 38.80 10.20 85 927682 23027 109638505
Device expulsion 38.79 10.20 131 927636 30760 109630772
Circulatory collapse 38.75 10.20 207 927560 42786 109618746
Cerebrovascular accident 38.74 10.20 1191 926576 180093 109481439
Acute chest syndrome 38.72 10.20 66 927701 2037 109659495
Delusion 38.55 10.20 89 927678 23666 109637866
Blood pressure decreased 38.55 10.20 706 927061 114385 109547147
Acidosis 38.55 10.20 82 927685 22449 109639083
Multiple fractures 38.53 10.20 163 927604 8777 109652755
Hyperuricaemia 38.46 10.20 39 927728 14492 109647040
Hepatitis cholestatic 38.16 10.20 55 927712 17511 109644021
Pneumatosis intestinalis 38.13 10.20 12 927755 8517 109653015
Subarachnoid haemorrhage 37.96 10.20 125 927642 29577 109631955
Ventricular fibrillation 37.75 10.20 198 927569 41115 109620417
Alanine aminotransferase increased 37.66 10.20 1214 926553 182559 109478973
Dyspepsia 37.57 10.20 1961 925806 189004 109472528
Muscle twitching 37.55 10.20 127 927640 29808 109631724
Hallucination, auditory 37.36 10.20 106 927661 26291 109635241
Potentiating drug interaction 37.27 10.20 26 927741 11617 109649915
Haemorrhage 37.15 10.20 650 927117 106042 109555490
Pseudomonas infection 37.14 10.20 115 927652 27738 109633794
Neck deformity 37.14 10.20 61 927706 1825 109659707
Colorectal cancer 37.03 10.20 15 927752 9099 109652433
Cardiomyopathy 36.97 10.20 150 927617 33375 109628157
Nephropathy toxic 36.97 10.20 113 927654 27365 109634167
Blood lactic acid increased 36.94 10.20 47 927720 15774 109645758
Personality disorder 36.86 10.20 32 927735 12805 109648727
Klebsiella infection 36.64 10.20 70 927697 19939 109641593
Coombs positive haemolytic anaemia 36.60 10.20 55 927712 1522 109660010
Tongue disorder 36.49 10.20 225 927542 14073 109647459
Lymphocyte count decreased 36.34 10.20 306 927461 56937 109604595
Lip swelling 36.30 10.20 262 927505 50405 109611127
Frequent bowel movements 36.26 10.20 819 926948 70571 109590961
Pulmonary embolism 36.19 10.20 1451 926316 213023 109448509
Hyperammonaemia 36.18 10.20 37 927730 13695 109647837
Injection site pruritus 36.16 10.20 618 927149 50640 109610892
Metastases to lung 36.16 10.20 88 927679 22975 109638557
Generalised oedema 36.02 10.20 134 927633 30570 109630962
Vomiting 36.02 10.20 6913 920854 903762 108757770
Coordination abnormal 35.93 10.20 101 927666 25127 109636405
Pulseless electrical activity 35.88 10.20 53 927714 16704 109644828
Cytomegalovirus chorioretinitis 35.71 10.20 8 927759 7120 109654412
Dissociation 35.66 10.20 19 927748 9823 109651709
Emotional distress 35.57 10.20 225 927542 44622 109616910
Red blood cell sedimentation rate 35.18 10.20 110 927657 5104 109656428
Weight decreased 35.09 10.20 4462 923305 463595 109197937
Hepatitis acute 34.94 10.20 65 927702 18701 109642831
Hepatitis fulminant 34.92 10.20 14 927753 8546 109652986
Obstructive airways disorder 34.85 10.20 235 927532 45914 109615618
Hypernatraemia 34.79 10.20 60 927707 17773 109643759
Gastroenteritis viral 34.74 10.20 408 927359 30818 109630714
Vasoplegia syndrome 34.47 10.20 3 927764 5436 109656096
Device leakage 34.13 10.20 51 927716 15997 109645535
Device related infection 34.13 10.20 193 927574 39326 109622206
Wheelchair user 33.82 10.20 143 927624 7699 109653833
Skin exfoliation 33.81 10.20 524 927243 87127 109574405
Hypomania 33.75 10.20 22 927745 10188 109651344
Device use error 33.74 10.20 17 927750 9072 109652460
Fear 33.67 10.20 92 927675 23101 109638431
Blood urea increased 33.45 10.20 297 927470 54660 109606872
Oedema 33.37 10.20 2115 925652 207861 109453671
Glycosylated haemoglobin increased 33.32 10.20 95 927672 23524 109638008
Progressive multifocal leukoencephalopathy 33.31 10.20 103 927664 24853 109636679
Back injury 33.27 10.20 571 927196 46828 109614704
Femur fracture 33.15 10.20 541 927226 43928 109617604
Hyperlactacidaemia 33.08 10.20 14 927753 8272 109653260
Forced expiratory volume decreased 33.05 10.20 37 927730 13139 109648393
Hypoalbuminaemia 32.99 10.20 128 927639 28846 109632686
Atrial tachycardia 32.84 10.20 18 927749 9160 109652372
Blood pressure increased 32.81 10.20 2555 925212 255818 109405714
Disability 32.79 10.20 393 927374 29830 109631702
Toxic encephalopathy 32.70 10.20 48 927719 15166 109646366
Smear cervix abnormal 32.55 10.20 71 927696 2641 109658891
Synovial cyst 32.47 10.20 185 927582 11245 109650287
Blood lactate dehydrogenase increased 32.37 10.20 228 927539 44106 109617426
Cardiac failure chronic 32.28 10.20 41 927726 13770 109647762
Bladder cancer 32.15 10.20 77 927690 20215 109641317
Metastases to central nervous system 32.02 10.20 92 927675 22725 109638807
Sleep terror 31.97 10.20 8 927759 6602 109654930
Skin toxicity 31.91 10.20 31 927736 11752 109649780
Spinal stenosis 31.90 10.20 271 927496 18785 109642747
Oropharyngeal pain 31.86 10.20 1414 926353 133862 109527670
Tendonitis 31.82 10.20 347 927420 25736 109635796
Abdominal pain upper 31.78 10.20 3370 924397 345741 109315791
Diabetes mellitus inadequate control 31.73 10.20 135 927632 29640 109631892
Myocardial ischaemia 31.60 10.20 116 927651 26568 109634964
Sexual dysfunction 31.60 10.20 16 927751 8514 109653018
Pulmonary arterial hypertension 31.51 10.20 153 927614 32415 109629117
Orthostatic hypotension 31.32 10.20 380 927387 65869 109595663
Motor dysfunction 30.99 10.20 103 927664 24303 109637229
Neck mass 30.97 10.20 100 927667 4721 109656811
Endophthalmitis 30.86 10.20 15 927752 8172 109653360
Neurologic neglect syndrome 30.79 10.20 20 927747 9278 109652254
Latent tuberculosis 30.71 10.20 88 927679 3889 109657643
Virologic failure 30.66 10.20 3 927764 4949 109656583
Myopathy 30.56 10.20 107 927660 24853 109636679
Premature rupture of membranes 30.53 10.20 97 927670 4540 109656992
Alanine aminotransferase abnormal 30.52 10.20 157 927610 9177 109652355
International normalised ratio increased 30.41 10.20 528 927239 86244 109575288
Product administration error 30.41 10.20 185 927582 37032 109624500
Hepatocellular carcinoma 30.40 10.20 23 927744 9857 109651675
Hypogammaglobulinaemia 30.39 10.20 78 927689 19998 109641534
Hypertransaminasaemia 30.36 10.20 103 927664 24152 109637380
Hepatic encephalopathy 30.18 10.20 128 927639 28128 109633404
Hyperpyrexia 30.09 10.20 15 927752 8054 109653478
Mental disorder 30.06 10.20 196 927571 38595 109622937
Bronchitis 29.97 10.20 1608 926159 155424 109506108
Paralysis 29.97 10.20 53 927714 15547 109645985
Cyanosis 29.79 10.20 138 927629 29603 109631929
Immune-mediated enterocolitis 29.72 10.20 25 927742 10160 109651372
Bradykinesia 29.66 10.20 28 927739 10760 109650772
Pruritus genital 29.47 10.20 9 927758 6513 109655019
Drug tolerance decreased 29.40 10.20 357 927410 27183 109634349
Pneumonia bacterial 29.27 10.20 117 927650 26144 109635388
Palmoplantar keratoderma 29.19 10.20 5 927762 5382 109656150
Ventricular arrhythmia 29.14 10.20 25 927742 10062 109651470
Premature labour 29.11 10.20 153 927614 9019 109652513
Pulmonary congestion 29.09 10.20 147 927620 30819 109630713
Neck pain 28.98 10.20 1287 926480 121843 109539689
Foot operation 28.97 10.20 130 927637 7183 109654349
Carotid artery thrombosis 28.94 10.20 23 927744 9615 109651917
Immune-mediated myositis 28.94 10.20 8 927759 6178 109655354
Haematuria 28.80 10.20 506 927261 82499 109579033
Kidney transplant rejection 28.63 10.20 35 927732 11952 109649580
Accidental death 28.62 10.20 4 927763 5005 109656527
Arthritis infective 28.45 10.20 167 927600 10262 109651270
Strongyloidiasis 28.44 10.20 4 927763 4982 109656550
Haematemesis 28.34 10.20 338 927429 58770 109602762
Venoocclusive disease 28.27 10.20 9 927758 6341 109655191
Immunosuppressant drug level increased 28.24 10.20 34 927733 11690 109649842
Atrioventricular block complete 28.16 10.20 81 927686 20001 109641531
Fracture 28.08 10.20 325 927442 24463 109637069
Pulmonary haemorrhage 28.06 10.20 60 927707 16396 109645136
Paranoia 28.01 10.20 95 927672 22279 109639253
Exposure via ingestion 27.79 10.20 4 927763 4896 109656636
Liver function test increased 27.79 10.20 955 926812 87593 109573939
Peripheral sensory neuropathy 27.47 10.20 62 927705 16618 109644914
Glomerular filtration rate decreased 27.46 10.20 137 927630 28819 109632713
Bone marrow failure 27.28 10.20 332 927435 57516 109604016
Lymphopenia 27.21 10.20 211 927556 39959 109621573
Headache 27.16 10.20 8043 919724 874334 108787198
Accidental overdose 26.97 10.20 291 927476 51543 109609989
Acute graft versus host disease in intestine 26.93 10.20 7 927760 5632 109655900
Right ventricular failure 26.85 10.20 119 927648 25835 109635697
Ketoacidosis 26.78 10.20 27 927740 10060 109651472
Hypoxic-ischaemic encephalopathy 26.71 10.20 21 927746 8826 109652706
Acute pulmonary oedema 26.53 10.20 65 927702 16931 109644601
Human herpesvirus 6 infection 26.47 10.20 11 927756 6570 109654962
Depressed mood 26.44 10.20 355 927412 60454 109601078
Cross sensitivity reaction 26.42 10.20 7 927760 5560 109655972
Gastric haemorrhage 26.33 10.20 59 927708 15856 109645676
Treatment noncompliance 26.27 10.20 442 927325 72548 109588984
Acute lymphocytic leukaemia recurrent 26.13 10.20 8 927759 5779 109655753
Ankylosing spondylitis 26.12 10.20 222 927545 15390 109646142
Foot fracture 25.91 10.20 328 927439 25218 109636314
Herpes zoster 25.77 10.20 1134 926633 107245 109554287
Rotator cuff repair 25.71 10.20 58 927709 2208 109659324
Renal tubular necrosis 25.69 10.20 150 927617 30325 109631207
Euglycaemic diabetic ketoacidosis 25.64 10.20 36 927731 11587 109649945
Capillary leak syndrome 25.63 10.20 5 927762 4903 109656629
Drug effective for unapproved indication 25.56 10.20 50 927717 14117 109647415
Bradypnoea 25.52 10.20 21 927746 8628 109652904
Tubulointerstitial nephritis 25.42 10.20 312 927455 53972 109607560
Gastrooesophageal reflux disease 25.42 10.20 1795 925972 178181 109483351
Acute myeloid leukaemia recurrent 25.28 10.20 6 927761 5133 109656399
Taste disorder 25.21 10.20 723 927044 64664 109596868
Renal injury 25.14 10.20 77 927690 18636 109642896
Scleritis 25.08 10.20 101 927666 5319 109656213
Hypertension 25.01 10.20 4749 923018 505335 109156197
Diarrhoea 25.01 10.20 8880 918887 1130625 108530907
Sputum discoloured 24.94 10.20 135 927632 27810 109633722
Intracranial pressure increased 24.91 10.20 31 927736 10504 109651028
Hyperprolactinaemia 24.86 10.20 12 927755 6563 109654969
Transplant dysfunction 24.85 10.20 20 927747 8308 109653224
Blindness 24.62 10.20 191 927576 36168 109625364
Affective disorder 24.62 10.20 35 927732 11206 109650326
Vascular stent thrombosis 24.55 10.20 3 927764 4158 109657374
Metastasis 24.49 10.20 20 927747 8247 109653285
Hepatic cytolysis 24.45 10.20 320 927447 54733 109606799
Product administered to patient of inappropriate age 24.36 10.20 19 927748 8017 109653515
Limb deformity 24.33 10.20 78 927689 3668 109657864
Ileus paralytic 24.29 10.20 38 927729 11699 109649833
Oesophageal carcinoma 24.14 10.20 37 927730 11487 109650045
Lethargy 24.05 10.20 599 927168 92977 109568555
Hydrocephalus 24.04 10.20 31 927736 10344 109651188
Polyuria 23.82 10.20 73 927694 17665 109643867
Malignant mediastinal neoplasm 23.74 10.20 42 927725 1336 109660196
Atrioventricular block 23.72 10.20 68 927699 16809 109644723
Presyncope 23.65 10.20 279 927488 48608 109612924
Cholangitis 23.56 10.20 65 927702 16270 109645262
Anti-neutrophil cytoplasmic antibody positive vasculitis 23.55 10.20 8 927759 5409 109656123
Diplopia 23.52 10.20 231 927536 41663 109619869
Seronegative arthritis 23.45 10.20 190 927577 12987 109648545
Osteonecrosis 23.44 10.20 176 927591 33565 109627967
Flushing 23.38 10.20 684 927083 104052 109557480
Congestive cardiomyopathy 23.29 10.20 53 927714 14166 109647366
Pre-eclampsia 23.27 10.20 138 927629 8512 109653020
Nervous system disorder 23.22 10.20 163 927604 31558 109629974
Hypercapnia 23.21 10.20 36 927731 11123 109650409
Hypotonia 23.20 10.20 62 927705 15683 109645849
Brain injury 23.09 10.20 49 927718 13427 109648105
Electrolyte imbalance 23.03 10.20 199 927568 36829 109624703
Hepatitis B 23.02 10.20 28 927739 9584 109651948
Diabetes mellitus 22.95 10.20 646 927121 98735 109562797
Systemic candida 22.90 10.20 30 927737 9944 109651588
Tuberculosis 22.87 10.20 239 927528 17535 109643997
Disturbance in social behaviour 22.82 10.20 7 927760 5051 109656481
Dermatitis acneiform 22.74 10.20 45 927722 12650 109648882
Synovial disorder 22.70 10.20 66 927701 2941 109658591
Incoherent 22.62 10.20 22 927745 8336 109653196
Psychiatric decompensation 22.60 10.20 10 927757 5755 109655777
Hyperthyroidism 22.60 10.20 148 927619 29113 109632419
Anxiety 22.52 10.20 2542 925225 342536 109318996
White blood cell count decreased 22.50 10.20 1638 926129 227752 109433780
Pericardial effusion 22.42 10.20 341 927426 56876 109604656
Post procedural infection 22.39 10.20 195 927572 13614 109647918
Adjustment disorder 22.29 10.20 35 927732 10760 109650772
Sudden death 22.24 10.20 117 927650 24278 109637254
Epistaxis 21.99 10.20 882 926885 129490 109532042
Skin ulcer 21.91 10.20 694 927073 62951 109598581
Enterococcal infection 21.91 10.20 92 927675 20274 109641258
Bone disorder 21.88 10.20 273 927494 20919 109640613
Linear IgA disease 21.84 10.20 5 927762 4384 109657148
Intervertebral disc degeneration 21.79 10.20 240 927527 17845 109643687
Breast cancer stage I 21.72 10.20 18 927749 7369 109654163
Ventricular extrasystoles 21.54 10.20 107 927660 22534 109638998
Nightmare 21.52 10.20 215 927552 38648 109622884
Personality change 21.48 10.20 37 927730 10965 109650567
Bacterial sepsis 21.34 10.20 34 927733 10392 109651140
Pulmonary hypertension 21.33 10.20 330 927437 54890 109606642
Joint injury 21.31 10.20 462 927305 39532 109622000
Ankle arthroplasty 21.23 10.20 58 927709 2493 109659039
Systemic inflammatory response syndrome 21.06 10.20 49 927718 12994 109648538
Nephrectomy 20.96 10.20 59 927708 2581 109658951
Swollen tongue 20.93 10.20 368 927399 59994 109601538
Metabolic disorder 20.84 10.20 35 927732 10475 109651057
Type I hypersensitivity 20.83 10.20 14 927753 6379 109655153
Blood parathyroid hormone decreased 20.79 10.20 184 927583 12905 109648627
Antinuclear antibody positive 20.77 10.20 140 927627 9028 109652504
Exposure via skin contact 20.74 10.20 50 927717 13097 109648435
Varicella zoster virus infection 20.68 10.20 14 927753 6354 109655178
Injection site bruising 20.65 10.20 570 927197 50693 109610839
Cleft lip and palate 20.62 10.20 28 927739 704 109660828
Methaemoglobinaemia 20.62 10.20 28 927739 9140 109652392
Swelling face 20.59 10.20 603 927164 91718 109569814
Hypertensive crisis 20.52 10.20 120 927647 24252 109637280
Haemolysis 20.46 10.20 211 927556 15428 109646104
Poor venous access 20.44 10.20 304 927463 24218 109637314
Visual acuity reduced 20.41 10.20 172 927595 32001 109629531
Synovial fluid analysis 20.39 10.20 59 927708 2622 109658910
Granuloma skin 20.25 10.20 163 927604 11120 109650412
Amylase increased 20.24 10.20 47 927720 12472 109649060
Hallucinations, mixed 20.11 10.20 26 927741 8667 109652865
Laryngospasm 20.11 10.20 7 927760 4661 109656871
Sensory loss 20.07 10.20 102 927665 21355 109640177
Laryngeal oedema 20.06 10.20 32 927735 9775 109651757
Heparin-induced thrombocytopenia 20.03 10.20 41 927726 11383 109650149
Neutrophilia 19.93 10.20 35 927732 10294 109651238
Candida infection 19.90 10.20 283 927484 47726 109613806
Cryptococcosis 19.86 10.20 7 927760 4624 109656908
Erectile dysfunction 19.85 10.20 84 927683 18472 109643060
Skin papilloma 19.84 10.20 112 927655 6784 109654748
Rheumatoid lung 19.75 10.20 80 927687 4224 109657308
Hypovolaemia 19.73 10.20 104 927663 21570 109639962
Complications of transplanted kidney 19.67 10.20 20 927747 7422 109654110
Chills 19.65 10.20 1355 926412 189225 109472307
Infection reactivation 19.62 10.20 5 927762 4076 109657456
Hypoglycaemic coma 19.58 10.20 11 927756 5522 109656010
Affect lability 19.55 10.20 85 927682 18552 109642980
Lupus vasculitis 19.51 10.20 25 927742 593 109660939
Wrong product administered 19.50 10.20 39 927728 10921 109650611
Drug tolerance 19.48 10.20 219 927548 16366 109645166
Epstein-Barr virus associated lymphoproliferative disorder 19.35 10.20 8 927759 4794 109656738
Dry skin 19.31 10.20 723 927044 106930 109554602
Fracture delayed union 19.28 10.20 51 927716 2150 109659382
Bone pain 19.25 10.20 408 927359 64725 109596807
Anosmia 19.23 10.20 48 927719 12424 109649108
Hydrops foetalis 19.22 10.20 28 927739 753 109660779
Anticholinergic syndrome 19.17 10.20 6 927761 4274 109657258
Loose body in joint 19.17 10.20 39 927728 1381 109660151
COVID-19 pneumonia 19.14 10.20 209 927558 36934 109624598
Ataxia 19.08 10.20 161 927606 29947 109631585
Mouth ulceration 19.04 10.20 534 927233 47604 109613928
Tenosynovitis stenosans 19.01 10.20 70 927697 3533 109657999
Colitis 18.85 10.20 685 927082 101638 109559894
Nasal polyps 18.69 10.20 53 927714 13147 109648385
Eosinophil count increased 18.64 10.20 102 927665 20956 109640576
Cytomegalovirus colitis 18.63 10.20 19 927748 7042 109654490
Cyst 18.56 10.20 216 927551 16280 109645252
Salivary hypersecretion 18.55 10.20 79 927688 17342 109644190
Postoperative wound infection 18.50 10.20 208 927559 15545 109645987
Lipase increased 18.49 10.20 87 927680 18585 109642947
Ultrasound antenatal screen 18.38 10.20 26 927741 680 109660852
Product monitoring error 18.38 10.20 29 927738 8898 109652634
Behaviour disorder 18.33 10.20 33 927734 9614 109651918
Total lung capacity increased 18.33 10.20 10 927757 5102 109656430
Walking aid user 18.30 10.20 304 927463 24771 109636761
Respiration abnormal 18.24 10.20 34 927733 9775 109651757
Brain natriuretic peptide increased 18.19 10.20 42 927725 11167 109650365
Ulcer haemorrhage 18.11 10.20 278 927489 22293 109639239
Hypertriglyceridaemia 17.99 10.20 72 927695 16082 109645450
Kounis syndrome 17.97 10.20 14 927753 5911 109655621
Renal cancer 17.96 10.20 53 927714 12981 109648551
Epstein-Barr viraemia 17.96 10.20 4 927763 3575 109657957
Amyloid arthropathy 17.96 10.20 42 927725 1638 109659894
Mucocutaneous ulceration 17.94 10.20 27 927740 748 109660784
Leukoencephalopathy 17.88 10.20 31 927736 9164 109652368
Cardiac tamponade 17.84 10.20 43 927724 11264 109650268
Steroid diabetes 17.81 10.20 11 927756 5243 109656289
Catatonia 17.81 10.20 43 927724 11257 109650275
Pallor 17.79 10.20 350 927417 56117 109605415
Polydipsia 17.78 10.20 23 927744 7665 109653867
Dyspnoea exertional 17.76 10.20 703 927064 103357 109558175
Memory impairment 17.75 10.20 1900 925867 195044 109466488
Nail operation 17.72 10.20 42 927725 1652 109659880
Aspiration 17.72 10.20 167 927600 30366 109631166
Product label confusion 17.70 10.20 278 927489 22399 109639133
Normal newborn 17.69 10.20 270 927497 21626 109639906
Troponin increased 17.62 10.20 162 927605 29604 109631928
Retinal haemorrhage 17.61 10.20 33 927734 9468 109652064
Wrong patient received product 17.56 10.20 18 927749 6656 109654876
Left ventricular dysfunction 17.55 10.20 120 927647 23373 109638159
Pneumonitis 17.53 10.20 498 927269 76033 109585499
Genital haemorrhage 17.50 10.20 21 927746 7231 109654301
Liver disorder 17.45 10.20 1403 926364 140840 109520692
Arteriospasm coronary 17.41 10.20 31 927736 9069 109652463
Delayed graft function 17.31 10.20 7 927760 4250 109657282
Spondylitis 17.30 10.20 158 927609 11180 109650352
Gastric cancer 17.26 10.20 42 927725 10966 109650566
Accidental exposure to product by child 17.26 10.20 3 927764 3195 109658337
Rales 17.20 10.20 129 927638 24610 109636922
Polyomavirus viraemia 17.20 10.20 4 927763 3470 109658062
Bradyarrhythmia 17.19 10.20 10 927757 4924 109656608
Dermatitis bullous 17.16 10.20 82 927685 17447 109644085
Myoglobin blood increased 17.14 10.20 7 927760 4225 109657307
Sickle cell anaemia 17.12 10.20 27 927740 780 109660752
Lung opacity 17.08 10.20 46 927721 11606 109649926
Granulocyte count decreased 17.05 10.20 6 927761 3968 109657564
Anhedonia 17.03 10.20 69 927698 15359 109646173
Impaired work ability 17.02 10.20 314 927453 26105 109635427
Lymphadenitis 17.00 10.20 91 927676 5402 109656130
Musculoskeletal disorder 17.00 10.20 276 927491 22388 109639144
Human antichimeric antibody positive 16.95 10.20 42 927725 1700 109659832
Secondary adrenocortical insufficiency 16.90 10.20 8 927759 4426 109657106
Adverse drug reaction 16.90 10.20 1064 926703 104495 109557037
Multiple sclerosis relapse 16.88 10.20 308 927459 49932 109611600
Product prescribing error 16.83 10.20 316 927451 51015 109610517
Staphylococcal infection 16.83 10.20 452 927315 69492 109592040
Immune thrombocytopenia 16.76 10.20 115 927652 22379 109639153
Bone density increased 16.73 10.20 30 927737 965 109660567
Pulmonary pain 16.67 10.20 100 927667 6193 109655339
Immune-mediated hepatitis 16.66 10.20 19 927748 6692 109654840
Compartment syndrome 16.65 10.20 15 927752 5895 109655637
Oral herpes 16.51 10.20 408 927359 35672 109625860
Breast feeding 16.50 10.20 25 927742 697 109660835
Osteopenia 16.48 10.20 270 927497 21939 109639593
Nasal oedema 16.44 10.20 106 927661 6733 109654799
Renal tubular disorder 16.40 10.20 23 927744 7406 109654126
Clonus 16.40 10.20 30 927737 8686 109652846
Wound infection pseudomonas 16.39 10.20 51 927716 2360 109659172
Eyelid oedema 16.38 10.20 69 927698 15193 109646339
Trisomy 18 16.36 10.20 23 927744 598 109660934
Concomitant disease aggravated 16.35 10.20 76 927691 16288 109645244
Abortion incomplete 16.32 10.20 3 927764 3069 109658463
Viraemia 16.27 10.20 7 927760 4095 109657437
Type 1 diabetes mellitus 16.26 10.20 32 927735 9015 109652517
Deep vein thrombosis 16.23 10.20 984 926783 138903 109522629
Ingrown hair 16.22 10.20 26 927741 762 109660770
Rash morbilliform 16.21 10.20 26 927741 7925 109653607
Rhinovirus infection 16.20 10.20 48 927719 11741 109649791
Cardiac dysfunction 16.13 10.20 17 927750 6206 109655326
Heart rate irregular 16.11 10.20 389 927378 33885 109627647
Device occlusion 16.09 10.20 69 927698 15116 109646416
Drug screen positive 16.08 10.20 18 927749 6392 109655140
Troponin T increased 16.07 10.20 8 927759 4298 109657234
Facial paralysis 16.02 10.20 128 927639 24086 109637446
Hepatitis C 16.01 10.20 53 927714 12520 109649012
Cardiopulmonary failure 15.96 10.20 26 927741 7877 109653655
Areflexia 15.92 10.20 20 927747 6749 109654783
Autoimmune hepatitis 15.85 10.20 67 927700 14737 109646795
Hyperreflexia 15.83 10.20 35 927732 9450 109652082
Nephrotic syndrome 15.81 10.20 61 927706 13770 109647762
Joint noise 15.78 10.20 85 927682 5058 109656474
Endodontic procedure 15.78 10.20 60 927707 3076 109658456
Panniculitis 15.77 10.20 200 927567 15382 109646150
Gait disturbance 15.76 10.20 2610 925157 275598 109385934
Pancreatitis 15.72 10.20 633 927134 92900 109568632
Vascular purpura 15.66 10.20 6 927761 3765 109657767
Fanconi syndrome 15.64 10.20 5 927762 3514 109658018
Hepatic cancer 15.64 10.20 45 927722 11111 109650421
Lymphatic fistula 15.57 10.20 37 927730 1458 109660074
Mitochondrial toxicity 15.55 10.20 4 927763 3241 109658291
Blood folate increased 15.54 10.20 22 927745 576 109660956
Balance disorder 15.52 10.20 809 926958 115751 109545781
Dyslipidaemia 15.45 10.20 75 927692 15890 109645642
Skin cancer 15.43 10.20 222 927545 17562 109643970
Persecutory delusion 15.42 10.20 18 927749 6273 109655259
Obsessive-compulsive disorder 15.41 10.20 23 927744 7218 109654314
Aplastic anaemia 15.40 10.20 130 927637 24178 109637354
Injection site warmth 15.39 10.20 218 927549 17187 109644345
Femoral hernia incarcerated 15.34 10.20 37 927730 1472 109660060
Porphyria acute 15.34 10.20 232 927535 18548 109642984
Injection site swelling 15.24 10.20 649 927118 61141 109600391
Staphylococcal bacteraemia 15.23 10.20 80 927687 16608 109644924
Lower respiratory tract congestion 15.22 10.20 80 927687 4716 109656816
Dysphonia 15.21 10.20 503 927264 75426 109586106
Cogwheel rigidity 15.17 10.20 6 927761 3692 109657840
Intraocular pressure increased 15.15 10.20 44 927723 10832 109650700
Hypervolaemia 15.15 10.20 308 927459 49152 109612380
Hypopituitarism 15.15 10.20 9 927758 4381 109657151
Insomnia 15.12 10.20 3332 924435 357258 109304274
Infective pulmonary exacerbation of cystic fibrosis 15.11 10.20 68 927699 14703 109646829
Immunisation 15.11 10.20 4 927763 3179 109658353
Haematocrit decreased 15.10 10.20 689 927078 65428 109596104
Mood altered 15.08 10.20 111 927656 21264 109640268
Pemphigoid 15.05 10.20 100 927667 19607 109641925
Corneal oedema 15.04 10.20 4 927763 3169 109658363
Hypoventilation 15.04 10.20 28 927739 8053 109653479
Muscle spasms 15.03 10.20 2603 925164 275554 109385978
Body height below normal 15.03 10.20 45 927722 2039 109659493
Pain in jaw 15.00 10.20 321 927446 50856 109610676
Escherichia bacteraemia 14.99 10.20 40 927727 10124 109651408
Post-traumatic stress disorder 14.98 10.20 20 927747 6576 109654956
Neutropenic colitis 14.96 10.20 28 927739 8037 109653495
Parvovirus B19 infection 14.91 10.20 3 927764 2878 109658654
Aplasia 14.90 10.20 27 927740 7846 109653686
Acute lung injury 14.88 10.20 4 927763 3147 109658385
Hypertonia 14.88 10.20 30 927737 8376 109653156
Ejection fraction abnormal 14.85 10.20 63 927704 3397 109658135
Red blood cell count decreased 14.84 10.20 686 927081 65237 109596295
Short stature 14.84 10.20 30 927737 1057 109660475
Stillbirth 14.84 10.20 73 927694 4191 109657341
Cerebral toxoplasmosis 14.82 10.20 4 927763 3138 109658394
Premature delivery 14.80 10.20 349 927418 30283 109631249
Schizoaffective disorder 14.78 10.20 4 927763 3132 109658400
Reversible cerebral vasoconstriction syndrome 14.76 10.20 11 927756 4750 109656782
Epstein-Barr virus infection reactivation 14.63 10.20 8 927759 4076 109657456
Injection site rash 14.63 10.20 277 927490 23142 109638390
Bone density decreased 14.62 10.20 202 927565 15840 109645692
Nystagmus 14.60 10.20 49 927718 11528 109650004
Hypophagia 14.59 10.20 333 927434 52293 109609239
Vertigo 14.58 10.20 588 927179 86282 109575250
Gangrene 14.55 10.20 79 927688 16262 109645270
Brain herniation 14.55 10.20 33 927734 8830 109652702
Oculogyric crisis 14.48 10.20 7 927760 3825 109657707
Syringe issue 14.42 10.20 37 927730 9488 109652044
Ulcer 14.28 10.20 468 927299 42648 109618884
Coronary artery stenosis 14.28 10.20 63 927704 13695 109647837
Incorrect dose administered 14.24 10.20 717 927050 102924 109558608
Prerenal failure 14.22 10.20 10 927757 4449 109657083
Tooth disorder 14.20 10.20 336 927431 29173 109632359
Polyhydramnios 14.19 10.20 42 927725 1891 109659641
Inadequate analgesia 14.17 10.20 13 927754 5064 109656468
Cartilage injury 14.16 10.20 38 927729 1616 109659916
Disorganised speech 14.15 10.20 5 927762 3298 109658234
Subileus 14.14 10.20 20 927747 6417 109655115
Pharyngitis streptococcal 14.12 10.20 172 927595 13105 109648427
Lower gastrointestinal haemorrhage 14.02 10.20 94 927673 18392 109643140
Fear of injection 14.02 10.20 125 927642 8786 109652746
Drug hypersensitivity 14.00 10.20 4140 923627 449950 109211582
Tumour haemorrhage 13.97 10.20 14 927753 5231 109656301
Brain abscess 13.95 10.20 22 927745 6752 109654780
Asthma 13.94 10.20 2346 925421 247945 109413587
Malignant melanoma 13.92 10.20 209 927558 16682 109644850
Neoplasm recurrence 13.90 10.20 14 927753 5218 109656314
Breast cancer stage II 13.88 10.20 314 927453 27061 109634471
Pneumonia fungal 13.88 10.20 70 927697 14684 109646848
Malnutrition 13.85 10.20 154 927613 27125 109634407
Enterobacter infection 13.84 10.20 17 927750 5794 109655738
Small for dates baby 13.84 10.20 22 927745 640 109660892
Hypovolaemic shock 13.83 10.20 69 927698 14514 109647018
Eye movement disorder 13.81 10.20 39 927728 9689 109651843
Drug abuser 13.77 10.20 15 927752 5394 109656138
Vein disorder 13.76 10.20 95 927672 6175 109655357
Placental disorder 13.73 10.20 28 927739 993 109660539
Autonomic nervous system imbalance 13.67 10.20 17 927750 5763 109655769
Device loosening 13.66 10.20 25 927742 817 109660715
Maternal exposure during breast feeding 13.66 10.20 71 927696 4167 109657365
Psychomotor retardation 13.63 10.20 28 927739 7764 109653768
Liver transplant rejection 13.57 10.20 8 927759 3910 109657622
Lip oedema 13.56 10.20 27 927740 7573 109653959
Bundle branch block right 13.55 10.20 55 927712 12236 109649296
Candida sepsis 13.54 10.20 4 927763 2957 109658575
Necrotising fasciitis 13.52 10.20 27 927740 7564 109653968
Skin haemorrhage 13.48 10.20 138 927629 24689 109636843
Tonic clonic movements 13.47 10.20 4 927763 2948 109658584
Intestinal ischaemia 13.44 10.20 80 927687 16099 109645433
Benign ovarian tumour 13.40 10.20 18 927749 448 109661084
Hand fracture 13.33 10.20 115 927652 8007 109653525
Hydronephrosis 13.33 10.20 110 927657 20555 109640977
Cardiac septal defect 13.31 10.20 27 927740 954 109660578
Ligament rupture 13.28 10.20 68 927699 3967 109657565
Fungaemia 13.28 10.20 19 927748 6067 109655465
Induced labour 13.16 10.20 26 927741 901 109660631
Staphylococcal sepsis 13.12 10.20 89 927678 17365 109644167
Arterial occlusive disease 13.09 10.20 75 927692 15233 109646299
Dysuria 13.03 10.20 395 927372 59836 109601696
Bone density abnormal 13.01 10.20 66 927701 3837 109657695
Dermatitis exfoliative 13 10.20 50 927717 11297 109650235
Cold sweat 13.00 10.20 120 927647 21911 109639621
Loss of libido 12.99 10.20 5 927762 3128 109658404
Hypocoagulable state 12.97 10.20 3 927764 2612 109658920
Dyspnoea at rest 12.96 10.20 32 927735 8314 109653218
Pseudomembranous colitis 12.93 10.20 21 927746 6370 109655162
Diaphragmatic disorder 12.92 10.20 40 927727 1846 109659686
Transplant failure 12.89 10.20 17 927750 5618 109655914
Foetal distress syndrome 12.84 10.20 21 927746 626 109660906
Paresis 12.82 10.20 13 927754 4831 109656701
Blood prolactin increased 12.82 10.20 12 927755 4630 109656902
Increased tendency to bruise 12.80 10.20 153 927614 11605 109649927
Propofol infusion syndrome 12.78 10.20 3 927764 2586 109658946
Antibody test positive 12.77 10.20 56 927711 3064 109658468
Therapeutic product effect incomplete 12.71 10.20 2100 925667 221705 109439827
Foetal exposure during pregnancy 12.71 10.20 107 927660 7398 109654134
Pancreatic carcinoma 12.64 10.20 73 927694 14799 109646733
Bronchial obstruction 12.62 10.20 5 927762 3074 109658458
Nodal osteoarthritis 12.62 10.20 25 927742 868 109660664
Lymph gland infection 12.60 10.20 21 927746 636 109660896
Pulmonary function test abnormal 12.58 10.20 14 927753 4986 109656546
Plasma cell myeloma recurrent 12.58 10.20 25 927742 7017 109654515
Liver abscess 12.55 10.20 29 927738 7710 109653822
Head injury 12.55 10.20 270 927497 42747 109618785
Hypothyroidism 12.54 10.20 492 927275 72407 109589125
Pneumocystis jirovecii pneumonia 12.54 10.20 268 927499 42467 109619065
Depressive symptom 12.50 10.20 33 927734 8381 109653151
Extravascular haemolysis 12.47 10.20 17 927750 429 109661103
Delirium 12.47 10.20 969 926798 134056 109527476
Deafness transitory 12.43 10.20 28 927739 1065 109660467
Product preparation error 12.42 10.20 48 927719 10831 109650701
Cystoid macular oedema 12.41 10.20 4 927763 2796 109658736
Eating disorder 12.40 10.20 183 927584 30675 109630857
Breast cancer female 12.40 10.20 58 927709 12410 109649122
Knee operation 12.36 10.20 101 927666 6921 109654611
Product prescribing issue 12.36 10.20 60 927707 12712 109648820
Haemorrhagic transformation stroke 12.34 10.20 5 927762 3032 109658500
Immune-mediated myocarditis 12.31 10.20 7 927760 3491 109658041
Anal fissure 12.31 10.20 132 927635 9749 109651783
Pain of skin 12.29 10.20 108 927659 19921 109641611
Embolism 12.27 10.20 83 927684 16206 109645326
Hypophosphataemia 12.25 10.20 200 927567 32982 109628550
Mental impairment 12.22 10.20 126 927641 22513 109639019
Urinary incontinence 12.22 10.20 312 927455 48275 109613257
Blood phosphorus decreased 12.21 10.20 29 927738 7636 109653896
Drug clearance decreased 12.17 10.20 10 927757 4112 109657420
Rheumatic disorder 12.16 10.20 61 927706 3530 109658002
Alcohol interaction 12.16 10.20 8 927759 3686 109657846
Apnoea 12.11 10.20 66 927701 13573 109647959
Priapism 12.10 10.20 19 927748 5842 109655690
Acquired gene mutation 12.09 10.20 4 927763 2750 109658782
Radiation inflammation 12.09 10.20 27 927740 1021 109660511
Quadriparesis 12.05 10.20 13 927754 4694 109656838
Haemodialysis 12.04 10.20 93 927674 17626 109643906
Brain death 12.03 10.20 23 927744 6550 109654982
Haemorrhage in pregnancy 12.01 10.20 36 927731 1632 109659900
Hypokinesia 11.98 10.20 121 927646 21705 109639827
Tooth infection 11.96 10.20 257 927510 21959 109639573
Therapy non-responder 11.94 10.20 1501 926266 155806 109505726
Pancreatic steatosis 11.89 10.20 38 927729 1784 109659748
Hyperventilation 11.89 10.20 37 927730 8910 109652622
Electroencephalogram abnormal 11.83 10.20 21 927746 6152 109655380
End stage renal disease 11.81 10.20 119 927648 21354 109640178
Colitis microscopic 11.79 10.20 65 927702 13329 109648203
Nail injury 11.78 10.20 23 927744 790 109660742
Infection susceptibility increased 11.72 10.20 70 927697 4328 109657204
Pneumomediastinum 11.72 10.20 15 927752 5021 109656511
Spinal cord compression 11.69 10.20 29 927738 7523 109654009
Viral haemorrhagic cystitis 11.68 10.20 7 927760 3392 109658140
Anaesthetic complication 11.61 10.20 8 927759 3598 109657934
Tetany 11.60 10.20 8 927759 3596 109657936
Supraventricular tachycardia 11.57 10.20 140 927627 24282 109637250
Therapeutic response decreased 11.54 10.20 950 926817 95549 109565983
Pupillary reflex impaired 11.54 10.20 10 927757 4005 109657527
Mass 11.52 10.20 230 927537 19400 109642132
Extradural haematoma 11.49 10.20 7 927760 3362 109658170
Device breakage 11.48 10.20 68 927699 13701 109647831
Lacrimal disorder 11.46 10.20 18 927749 518 109661014
Disinhibition 11.43 10.20 6 927761 3128 109658404
Peritoneal dialysis complication 11.43 10.20 47 927720 2499 109659033
Large intestine perforation 11.43 10.20 87 927680 16542 109644990
Haemorrhage subcutaneous 11.40 10.20 18 927749 5521 109656011
Drooling 11.38 10.20 27 927740 7112 109654420
Injection site extravasation 11.37 10.20 133 927634 10036 109651496
Central nervous system mass 11.37 10.20 23 927744 811 109660721
Maternal exposure during delivery 11.36 10.20 8 927759 3557 109657975
Spinal osteoarthritis 11.35 10.20 235 927532 19948 109641584
Placental insufficiency 11.35 10.20 30 927737 1264 109660268
Blood pressure inadequately controlled 11.29 10.20 30 927737 7603 109653929
Angina unstable 11.28 10.20 86 927681 16346 109645186
Tension headache 11.27 10.20 42 927725 9576 109651956
Upper respiratory tract inflammation 11.27 10.20 12 927755 4359 109657173
Gastrointestinal perforation 11.26 10.20 29 927738 7427 109654105
Wall motion score index abnormal 11.24 10.20 23 927744 818 109660714
Post procedural haemorrhage 11.21 10.20 80 927687 15432 109646100
Metastases to meninges 11.20 10.20 16 927751 5112 109656420
Cervical incompetence 11.19 10.20 18 927749 529 109661003
Device malfunction 11.19 10.20 149 927618 25409 109636123
Coronary artery bypass 11.18 10.20 21 927746 6021 109655511
Paraesthesia 11.18 10.20 2551 925216 273970 109387562
Prescription drug used without a prescription 11.18 10.20 18 927749 5478 109656054
Poor quality device used 11.17 10.20 5 927762 2858 109658674
Hepatosplenomegaly 11.17 10.20 26 927741 6893 109654639
Defaecation disorder 11.16 10.20 23 927744 822 109660710
Hyporesponsive to stimuli 11.15 10.20 5 927762 2855 109658677
Peripheral sensorimotor neuropathy 11.12 10.20 10 927757 3933 109657599
Stupor 11.11 10.20 34 927733 8231 109653301
Drug eruption 11.10 10.20 354 927413 53305 109608227
Skin graft failure 11.03 10.20 12 927755 238 109661294
Psychomotor skills impaired 11.01 10.20 27 927740 7031 109654501
Eye pruritus 10.99 10.20 201 927566 32574 109628958
Hernia 10.95 10.20 227 927540 19273 109642259
Mycobacterium chelonae infection 10.95 10.20 6 927761 3054 109658478
Vertebral osteophyte 10.95 10.20 18 927749 539 109660993
Hepatitis A antibody abnormal 10.91 10.20 9 927758 124 109661408
Cerebellar haemorrhage 10.88 10.20 7 927760 3264 109658268
Swollen joint count 10.86 10.20 116 927651 8558 109652974
Cell death 10.83 10.20 20 927747 5771 109655761
Metastases to peritoneum 10.83 10.20 19 927748 5591 109655941
Blood test abnormal 10.80 10.20 315 927452 28239 109633293
Atrial flutter 10.78 10.20 141 927626 24121 109637411
Peripheral motor neuropathy 10.78 10.20 11 927756 4075 109657457
Atrioventricular block second degree 10.75 10.20 34 927733 8147 109653385
Ischaemic cardiomyopathy 10.74 10.20 33 927734 7978 109653554
Upper gastrointestinal haemorrhage 10.72 10.20 329 927438 49767 109611765
Bone cyst 10.69 10.20 59 927708 3544 109657988
Cholecystitis acute 10.64 10.20 83 927684 15699 109645833
Product substitution issue 10.63 10.20 133 927634 22928 109638604
Back disorder 10.62 10.20 240 927527 20682 109640850
Cyst rupture 10.61 10.20 23 927744 852 109660680
COVID-19 10.59 10.20 1851 925916 243209 109418323
Hyperleukocytosis 10.59 10.20 8 927759 3431 109658101
Enterovirus infection 10.56 10.20 5 927762 2765 109658767
Renal tubular atrophy 10.54 10.20 3 927764 2273 109659259
Organising pneumonia 10.52 10.20 73 927694 14170 109647362
Complication of device removal 10.50 10.20 14 927753 4606 109656926
Human anti-human antibody test 10.50 10.20 15 927752 396 109661136
Urticaria 10.49 10.20 2915 924852 315942 109345590
Fixed eruption 10.49 10.20 12 927755 4220 109657312
Trismus 10.47 10.20 25 927742 6571 109654961
Influenza 10.43 10.20 1594 926173 167507 109494025
Bacterial infection 10.43 10.20 300 927467 45736 109615796
Vitamin D decreased 10.40 10.20 152 927615 12063 109649469
CD4 lymphocytes decreased 10.40 10.20 6 927761 2968 109658564
Catheter site haemorrhage 10.40 10.20 21 927746 5859 109655673
Pulse absent 10.38 10.20 54 927713 11238 109650294
Prostatic specific antigen increased 10.32 10.20 62 927705 12449 109649083
Hepatitis E antibody positive 10.31 10.20 12 927755 257 109661275
Lymphoedema 10.31 10.20 78 927689 14851 109646681
Tender joint count increased 10.31 10.20 15 927752 403 109661129
Device issue 10.30 10.20 216 927551 34319 109627213
Pancreatitis necrotising 10.29 10.20 19 927748 5482 109656050
Accidental poisoning 10.26 10.20 4 927763 2483 109659049
Skin plaque 10.26 10.20 63 927704 12582 109648950
Vascular pseudoaneurysm 10.25 10.20 12 927755 4178 109657354
Transient aphasia 10.20 10.20 20 927747 689 109660843

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11HA01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
OTHER PLAIN VITAMIN PREPARATIONS
Other plain vitamin preparations
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
MeSH PA D018977 Micronutrients
CHEBI has role CHEBI:22586 antioxidant
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:25212 metabolite
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:61115 EC 3.5.1.98 (histone deacetylase) inhibitor
CHEBI has role CHEBI:62913 EC 2.4.2.30 (NAD<small><sup>+</small></sup> ADP-ribosyltransferase) inhibitor
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:71181 Sir2 inhibitor
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:75772 <em>Saccharomyces cerevisiae </em> metabolite
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:76971 <em>Escherichia coli</em> metabolite
CHEBI has role CHEBI:84087 human urinary metabolite
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

A11HA Other plain vitamin preparations 10 drugs

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

DiseaseRelationSNOMED_IDDOID
Acne vulgaris indication 88616000
Pellagra indication 418186002 DOID:8457
Niacin deficiency indication 418279001
Methemoglobinemia off-label use 38959009 DOID:10783
Goiter contraindication 3716002 DOID:12176
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Primary hyperoxaluria contraindication 17901006 DOID:2977
Hashimoto thyroiditis contraindication 21983002
Acute tuberculosis contraindication 25629007
Bronchitis contraindication 32398004 DOID:6132
Low blood pressure contraindication 45007003
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Hemophilia contraindication 90935002
Dermatitis herpetiformis contraindication 111196000 DOID:8505
Anemia due to enzyme deficiency contraindication 111577008
Hb SS disease contraindication 127040003 DOID:10923
Arterial hemorrhage contraindication 234003006
Disease of liver contraindication 235856003 DOID:409
Hypocomplementemic urticarial vasculitis contraindication 239945009
Rhabdomyolysis contraindication 240131006
Pregnancy, function contraindication 289908002
Acute coronary syndrome contraindication 394659003
Hemochromatosis contraindication 399187006 DOID:2352




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.95 acidic
pKa2 3.41 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML MULTIPLE VITAMINS INJECTION ADULT APOTEX A210672 April 9, 2026 RX SOLUTION INTRAVENOUS Dec. 1, 2026 COMPETITIVE GENERIC THERAPY
80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL MULTIPLE VITAMINS INJECTION PEDIATRIC APOTEX A210671 April 21, 2026 RX INJECTABLE INTRAVENOUS Dec. 21, 2026 COMPETITIVE GENERIC THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Hydroxycarboxylic acid receptor 2 GPCR WOMBAT-PK
Hydroxycarboxylic acid receptor 3 GPCR WOMBAT-PK
Nicotinamide N-methyltransferase Enzyme WOMBAT-PK
Nicotinate-nucleotide pyrophosphorylase [carboxylating] Enzyme WOMBAT-PK
NAD-dependent protein deacetylase sirtuin-1 Enzyme IC50 4.30 CHEMBL
NAD-dependent protein deacetylase sirtuin-2 Enzyme IC50 5.92 CHEMBL
NAD-dependent deacetylase sirtuin 3 Enzyme IC50 4.85 CHEMBL
NAD-dependent protein deacylase sirtuin-5, mitochondrial Enzyme IC50 4.33 CHEMBL
Sterile alpha and TIR motif-containing protein 1 Enzyme IC50 4.36 CHEMBL
NAD-dependent protein deacetylase sirtuin-6 Enzyme IC50 4.35 CHEMBL
Fatty-acid amide hydrolase 1 Enzyme IC50 5.48 CHEMBL
NAD-dependent deacetylase HST2 Enzyme IC50 4.04 CHEMBL
Putative silent information regulator 2 Enzyme IC50 4.40 CHEMBL
NAD-dependent protein deacetylase Enzyme IC50 4.64 CHEMBL
NAD-dependent protein deacetylase Enzyme IC50 4.41 CHEMBL

External reference:

IDSource
4020285 VUID
N0000148162 NUI
D00036 KEGG_DRUG
4017632 VANDF
4017718 VANDF
4020285 VANDF
C0028027 UMLSCUI
CHEBI:17154 CHEBI
NCA PDB_CHEM_ID
CHEMBL1140 ChEMBL_ID
936 PUBCHEM_CID
DB02701 DRUGBANK_ID
7405 RXNORM
4947 MMSL
5170 MMSL
5684 MMSL
59920 MMSL
72420 MMSL
d03739 MMSL
001055 NDDF
173196005 SNOMEDCT_US
D009536 MESH_DESCRIPTOR_UI
404 INN_ID
25X51I8RD4 UNII
25X51I8RD4 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 20 mg ORAL Unapproved drug other 12 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 DHA HUMAN OTC DRUG LABEL 14 0178-0898 TABLET 20 mg ORAL Unapproved drug other 11 sections
VitafolUltra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 15 mg ORAL unapproved drug other 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 15 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Strovite OneCaplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 25 mg ORAL unapproved drug other 14 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 15 mg ORAL unapproved drug other 14 sections
Marnatal F HUMAN PRESCRIPTION DRUG LABEL 13 0682-1570 CAPSULE 20 mg ORAL UNAPPROVED DRUG OTHER 4 sections
BACMIN HUMAN PRESCRIPTION DRUG LABEL 19 0682-3001 TABLET, COATED 100 mg ORAL UNAPPROVED DRUG OTHER 10 sections
Dialyvite Supreme D HUMAN PRESCRIPTION DRUG LABEL 13 10542-009 TABLET, COATED 20 mg ORAL Unapproved drug other 7 sections
Dialyvite HUMAN PRESCRIPTION DRUG LABEL 9 10542-010 TABLET, COATED 20 mg ORAL Unapproved drug other 7 sections
Dialyvite 5000 HUMAN PRESCRIPTION DRUG LABEL 12 10542-011 TABLET, COATED 20 mg ORAL Unapproved drug other 7 sections
Dialyvite with Zinc HUMAN PRESCRIPTION DRUG LABEL 10 10542-012 TABLET, COATED 20 mg ORAL Unapproved drug other 7 sections
Dialyvite 3000 HUMAN PRESCRIPTION DRUG LABEL 12 10542-014 TABLET, COATED 20 mg ORAL Unapproved drug other 7 sections
PRENATAL PLUS HUMAN PRESCRIPTION DRUG LABEL 15 10544-549 TABLET, FILM COATED 20 mg ORAL unapproved drug other 8 sections
PRENATAL PLUS IRON HUMAN PRESCRIPTION DRUG LABEL 15 10544-609 TABLET, FILM COATED 20 mg ORAL UNAPPROVED DRUG OTHER 7 sections
Se-Natal 19 HUMAN PRESCRIPTION DRUG LABEL 15 13925-116 TABLET 15 mg ORAL unapproved drug other 15 sections
Se-Natal 19 Chewable HUMAN PRESCRIPTION DRUG LABEL 14 13925-117 TABLET, CHEWABLE 15 mg ORAL unapproved drug other 16 sections
Se-Tan PLUS HUMAN PRESCRIPTION DRUG LABEL 13 13925-118 CAPSULE, GELATIN COATED 30 ug ORAL unapproved drug other 18 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 13 15370-100 LIQUID 0.80 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Quflora Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 13 15370-101 LIQUID 2 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Quflora FE Pediatric Drops HUMAN PRESCRIPTION DRUG LABEL 14 15370-102 LIQUID 4 mg ORAL UNAPPROVED DRUG OTHER 11 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-103 TABLET, CHEWABLE 5 mg ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-104 TABLET, CHEWABLE 5 mg ORAL UNAPPROVED DRUG OTHER 12 sections
Quflora Pediatric HUMAN PRESCRIPTION DRUG LABEL 14 15370-105 TABLET, CHEWABLE 5 mg ORAL UNAPPROVED DRUG OTHER 12 sections
Dialyvite HUMAN PRESCRIPTION DRUG LABEL 9 17856-0010 TABLET, COATED 20 mg ORAL Unapproved drug other 8 sections
PRENATAL PLUS HUMAN PRESCRIPTION DRUG LABEL 15 17856-0668 TABLET, FILM COATED 20 mg ORAL UNAPPROVED DRUG OTHER 6 sections