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

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 1631.56 9.92 3087 374670 117079 50110288
Systemic lupus erythematosus 1513.32 9.92 3280 374477 137342 50090025
Glossodynia 1301.99 9.92 2747 375010 112822 50114545
Rheumatoid arthritis 1064.49 9.92 3627 374130 198923 50028444
Hand deformity 1037.03 9.92 2302 375455 97897 50129470
Arthropathy 938.21 9.92 2949 374808 154957 50072410
Maternal exposure during pregnancy 929.22 9.92 2962 374795 156816 50070551
Alopecia 914.42 9.92 3935 373822 241112 49986255
Abdominal discomfort 904.77 9.92 3772 373985 227869 49999498
Wound 847.35 9.92 2201 375556 103593 50123774
Completed suicide 752.22 9.92 62 377695 131827 50095540
Infusion related reaction 672.95 9.92 2776 374981 166781 50060586
Synovitis 671.64 9.92 2243 375514 121622 50105745
Pericarditis 645.14 9.92 1652 376105 77037 50150330
Anti-cyclic citrullinated peptide antibody positive 634.55 9.92 1535 376222 69052 50158315
Contraindicated product administered 621.35 9.92 2477 375280 146481 50080886
Discomfort 605.67 9.92 1983 375774 106397 50120970
Swelling 586.46 9.92 3005 374752 197867 50029500
Joint swelling 571.38 9.92 3452 374305 241834 49985533
Pain 559.59 9.92 6683 371074 572220 49655147
Toxicity to various agents 553.56 9.92 464 377293 212035 50015332
Death 456.73 9.92 1104 376653 324275 49903092
Product use issue 390.66 9.92 2170 375587 147305 50080062
Rheumatoid factor positive 388.16 9.92 1027 376730 48832 50178535
Duodenal ulcer perforation 365.78 9.92 950 376807 44661 50182706
Arthralgia 363.58 9.92 4926 372831 433776 49793591
Helicobacter infection 354.15 9.92 991 376766 48711 50178656
Drug interaction 330.99 9.92 616 377141 199005 50028362
Hepatic enzyme increased 323.36 9.92 1940 375817 135440 50091927
Drug abuse 320.30 9.92 36 377721 59810 50167557
Intentional overdose 311.94 9.92 47 377710 62457 50164910
Exposure during pregnancy 282.24 9.92 1705 376052 119310 50108057
Drug intolerance 249.00 9.92 2615 375142 216489 50010878
Musculoskeletal stiffness 248.62 9.92 1727 376030 126754 50100613
Hip arthroplasty 245.17 9.92 635 377122 29794 50197573
Therapeutic product effect decreased 238.59 9.92 1786 375971 134264 50093103
Treatment failure 231.93 9.92 1790 375967 135847 50091520
Knee arthroplasty 225.77 9.92 684 377073 35162 50192205
Febrile neutropenia 215.03 9.92 247 377510 97420 50129947
Overdose 208.10 9.92 263 377494 99464 50127903
Suicide attempt 195.06 9.92 71 377686 51661 50175706
Psoriatic arthropathy 193.18 9.92 779 376978 46253 50181114
Acute kidney injury 192.04 9.92 962 376795 227096 50000271
Nasopharyngitis 190.02 9.92 2239 375518 190688 50036679
Cardiac arrest 186.91 9.92 209 377548 83442 50143925
Depressed level of consciousness 178.53 9.92 82 377675 51871 50175496
Red blood cell sedimentation rate abnormal 167.06 9.92 374 377383 15969 50211398
Hypersensitivity 164.10 9.92 2383 375374 212778 50014589
Malignant neoplasm progression 162.52 9.92 161 377596 67963 50159404
Diarrhoea 154.83 9.92 3285 374472 585191 49642176
C-reactive protein abnormal 151.65 9.92 505 377252 27304 50200063
Disease progression 151.58 9.92 304 377453 95562 50131805
Device expulsion 147.69 9.92 20 377737 28802 50198565
Drug hypersensitivity 147.33 9.92 1183 376574 249827 49977540
Impaired healing 146.82 9.92 958 376799 68828 50158539
Rheumatic fever 140.00 9.92 356 377401 16511 50210856
Constipation 139.32 9.92 814 376943 184894 50042473
Drug ineffective 137.09 9.92 7444 370313 811889 49415478
Nausea 137.06 9.92 4118 373639 701280 49526087
Swollen joint count increased 135.16 9.92 325 377432 14548 50212819
Sickle cell anaemia with crisis 131.58 9.92 166 377591 4377 50222990
Bradycardia 131.17 9.92 173 377584 64253 50163114
Neutropenia 129.15 9.92 616 377141 147349 50080018
Lactic acidosis 127.06 9.92 45 377712 33310 50194057
Sedation 126.02 9.92 36 377721 30574 50196793
Cardiac failure 124.65 9.92 236 377521 75804 50151563
Asthenia 121.66 9.92 1664 376093 317378 49909989
Hyponatraemia 121.62 9.92 343 377414 95796 50131571
Tremor 118.33 9.92 449 377308 114454 50112913
Electrocardiogram QT prolonged 116.58 9.92 129 377628 51757 50175610
Anxiety 115.56 9.92 813 376944 176793 50050574
Hypotension 114.44 9.92 1164 376593 234305 49993062
Pregnancy 109.78 9.92 475 377282 29102 50198265
Dyspnoea 107.80 9.92 3190 374567 544418 49682949
Dizziness 107.13 9.92 1880 375877 344489 49882878
Respiratory arrest 105.23 9.92 46 377711 29963 50197404
Fatigue 104.37 9.92 6358 371399 701243 49526124
Agitation 103.99 9.92 148 377609 53236 50174131
Vomiting 101.41 9.92 2642 375115 458116 49769251
Psoriasis 101.28 9.92 870 376887 68130 50159237
Sleep disorder due to general medical condition, insomnia type 101.04 9.92 484 377273 30963 50196404
Renal failure 100.76 9.92 431 377326 106202 50121165
Rash 100.60 9.92 4105 373652 433366 49794001
Muscle injury 99.56 9.92 543 377214 36568 50190799
Folliculitis 98.63 9.92 564 377193 38661 50188706
Somnolence 98.58 9.92 714 377043 154271 50073096
Arthritis 97.30 9.92 1033 376724 85688 50141679
Live birth 96.71 9.92 306 377451 16102 50211265
Abortion spontaneous 94.99 9.92 585 377172 41187 50186180
Drug reaction with eosinophilia and systemic symptoms 94.37 9.92 47 377710 28377 50198990
Multiple sclerosis relapse 93.07 9.92 110 377647 42854 50184513
Lower respiratory tract infection 92.74 9.92 1103 376654 94098 50133269
Osteoarthritis 92.43 9.92 849 376908 67757 50159610
Blister 92.36 9.92 1010 376747 84408 50142959
Rhabdomyolysis 91.05 9.92 94 377663 38933 50188434
Sopor 90.36 9.92 19 377738 19860 50207507
Neoplasm progression 87.03 9.92 55 377702 29102 50198265
Intentional self-injury 86.64 9.92 32 377725 23080 50204287
Hyperhidrosis 84.75 9.92 361 377396 89065 50138302
Injection site erythema 82.37 9.92 889 376868 74047 50153320
Neuropathy peripheral 80.81 9.92 409 377348 96348 50131019
Insomnia 79.79 9.92 877 376880 173988 50053379
Cardio-respiratory arrest 79.22 9.92 178 377579 53714 50173653
Condition aggravated 78.72 9.92 2832 374925 294226 49933141
Tachycardia 78.13 9.92 431 377326 99332 50128035
Syncope 77.42 9.92 451 377306 102551 50124816
Drug withdrawal syndrome 76.68 9.92 46 377711 25035 50202332
Blood pressure fluctuation 76.67 9.92 494 377263 35329 50192038
Drug dependence 74.67 9.92 27 377730 19732 50207635
Serotonin syndrome 74.61 9.92 46 377711 24667 50202700
Product quality issue 73.50 9.92 73 377684 30785 50196582
Hypoglycaemia 73.17 9.92 184 377573 53397 50173970
Myalgia 72.77 9.92 586 377171 123733 50103634
Irritable bowel syndrome 72.04 9.92 642 377115 50799 50176568
Hepatic failure 71.71 9.92 81 377676 32202 50195165
Joint effusion 70.57 9.92 236 377521 12785 50214582
Injection site pruritus 69.30 9.92 528 377229 39883 50187484
Encephalopathy 69.14 9.92 90 377667 33621 50193746
Cognitive disorder 68.79 9.92 141 377616 43982 50183385
Hypoxia 68.69 9.92 177 377580 50946 50176421
Palmar-plantar erythrodysaesthesia syndrome 67.07 9.92 33 377724 20065 50207302
Anaemia 66.39 9.92 1408 376349 251048 49976319
Caesarean section 64.96 9.92 260 377497 15379 50211988
Basal cell carcinoma 64.17 9.92 344 377413 23012 50204355
Respiratory failure 63.94 9.92 408 377349 90773 50136594
Renal impairment 63.64 9.92 319 377438 75342 50152025
Disability assessment scale score increased 63.33 9.92 83 377674 2275 50225092
Juvenile idiopathic arthritis 63.28 9.92 92 377665 2787 50224580
Hyperglycaemia 63.21 9.92 109 377648 36296 50191071
Metabolic acidosis 63.17 9.92 121 377636 38704 50188663
Drug resistance 62.14 9.92 32 377725 18957 50208410
Sinusitis 62.04 9.92 1690 376067 168868 50058499
Thrombocytopenia 61.99 9.92 631 377126 127042 50100325
Intentional product misuse 61.88 9.92 163 377594 46571 50180796
No adverse event 61.60 9.92 97 377660 33481 50193886
Red blood cell sedimentation rate increased 60.12 9.92 401 377356 29015 50198352
Asthma 59.00 9.92 407 377350 88930 50138437
Urticaria 58.99 9.92 650 377107 128911 50098456
Cardiac failure congestive 58.95 9.92 378 377379 84004 50143363
Foot deformity 58.37 9.92 291 377466 18919 50208448
Multiple organ dysfunction syndrome 57.61 9.92 188 377569 50149 50177218
Diabetic ketoacidosis 57.18 9.92 31 377726 17841 50209526
Hepatic function abnormal 56.61 9.92 98 377659 32583 50194784
Joint laxity 56.19 9.92 79 377678 2319 50225048
Feeling abnormal 56.17 9.92 632 377125 124860 50102507
Contusion 55.87 9.92 1161 376596 111022 50116345
Muscle spasms 55.53 9.92 634 377123 124919 50102448
Fluid retention 54.68 9.92 194 377563 50455 50176912
Ill-defined disorder 54.42 9.92 636 377121 54018 50173349
Blood cholesterol increased 54.30 9.92 641 377116 54574 50172793
Cholestasis 53.98 9.92 66 377691 25335 50202032
Hallucination 53.58 9.92 174 377583 46483 50180884
Sedation complication 53.19 9.92 3 377754 8763 50218604
Altered state of consciousness 53.14 9.92 51 377706 21859 50205508
Balance disorder 53.08 9.92 309 377448 70281 50157086
Osteoporosis 52.87 9.92 540 377217 44339 50183028
Blood pressure diastolic abnormal 52.82 9.92 172 377585 9189 50218178
Respiratory disorder 52.68 9.92 95 377662 31092 50196275
Injection site reaction 52.41 9.92 588 377169 49444 50177923
Injection site swelling 52.29 9.92 509 377248 41264 50186103
Blood glucose increased 52.15 9.92 315 377442 71009 50156358
Pulmonary embolism 52.15 9.92 496 377261 101208 50126159
Disturbance in attention 51.78 9.92 96 377661 31090 50196277
Orthostatic hypotension 51.43 9.92 88 377669 29393 50197974
Dehydration 51.40 9.92 814 376943 151635 50075732
Injection site pain 51.11 9.92 1136 376621 109888 50117479
Seizure 51.05 9.92 598 377159 117276 50110091
Peripheral swelling 51.01 9.92 1949 375808 203987 50023380
Cytomegalovirus infection 50.76 9.92 36 377721 17926 50209441
Grip strength decreased 50.73 9.92 202 377555 11919 50215448
Coma 50.63 9.92 235 377522 56644 50170723
Fibromyalgia 50.53 9.92 536 377221 44442 50182925
Muscle spasticity 50.48 9.92 33 377724 17151 50210216
Chest discomfort 50.22 9.92 446 377311 92276 50135091
Type 2 diabetes mellitus 50.19 9.92 433 377324 33942 50193425
Foetal exposure during pregnancy 50.05 9.92 363 377394 26996 50200371
Hypokalaemia 49.55 9.92 419 377338 87573 50139794
Mental status changes 49.18 9.92 125 377632 36147 50191220
Vision blurred 48.68 9.92 365 377392 78282 50149085
Mydriasis 48.63 9.92 10 377747 10617 50216750
Metastases to bone 48.36 9.92 38 377719 17957 50209410
Neutrophil count decreased 47.90 9.92 179 377578 45847 50181520
Premature labour 47.83 9.92 191 377566 11285 50216082
Hepatocellular injury 47.55 9.92 75 377682 25872 50201495
Bone erosion 47.50 9.92 193 377564 11494 50215873
Ejection fraction decreased 47.43 9.92 41 377716 18479 50208888
Loss of personal independence in daily activities 47.16 9.92 760 376997 69290 50158077
Emotional distress 46.92 9.92 89 377668 28574 50198793
Pulmonary arterial hypertension 46.20 9.92 50 377707 20269 50207098
Decreased appetite 45.91 9.92 1145 376612 199778 50027589
Restlessness 45.91 9.92 73 377684 25100 50202267
Hyperkalaemia 45.62 9.92 194 377563 47895 50179472
Anaphylactic reaction 45.40 9.92 228 377529 53827 50173540
Blood pressure systolic increased 45.38 9.92 434 377323 35015 50192352
White blood cell count decreased 45.35 9.92 606 377151 116116 50111251
Poisoning 45.27 9.92 18 377739 12411 50214956
Depression 45.09 9.92 917 376840 164506 50062861
Loss of consciousness 44.95 9.92 530 377227 103823 50123544
Infection 44.77 9.92 1645 376112 171309 50056058
Blood pressure systolic abnormal 44.76 9.92 143 377614 7563 50219804
Gestational diabetes 44.71 9.92 140 377617 7325 50220042
Delirium 44.15 9.92 142 377615 38050 50189317
Product use in unapproved indication 43.67 9.92 605 377152 115214 50112153
Dyspnoea exertional 43.65 9.92 215 377542 51018 50176349
Osteonecrosis of jaw 43.39 9.92 113 377644 32413 50194954
Neck deformity 43.17 9.92 63 377694 1915 50225452
Product administration error 43.12 9.92 50 377707 19649 50207718
Hypothermia 42.80 9.92 18 377739 11998 50215369
Respiratory depression 42.76 9.92 18 377739 11992 50215375
Speech disorder 42.62 9.92 130 377627 35418 50191949
Shock 42.48 9.92 55 377702 20595 50206772
Maternal drugs affecting foetus 41.96 9.92 107 377650 4970 50222397
Suicidal ideation 41.87 9.92 242 377515 55143 50172224
Disorientation 41.67 9.92 131 377626 35353 50192014
Leukopenia 41.50 9.92 314 377443 67214 50160153
Multiple fractures 41.46 9.92 126 377631 6485 50220882
Tuberculosis 41.37 9.92 167 377590 9916 50217451
Extrapyramidal disorder 41.33 9.92 18 377739 11752 50215615
Hospitalisation 41.23 9.92 317 377440 67620 50159747
Weight increased 40.74 9.92 1870 375887 200021 50027346
Creatinine renal clearance decreased 40.42 9.92 19 377738 11862 50215505
Blood pressure decreased 40.31 9.92 248 377509 55661 50171706
Rheumatoid nodule 40.18 9.92 195 377562 12540 50214827
Memory impairment 39.84 9.92 389 377368 78971 50148396
Acute hepatic failure 39.79 9.92 35 377722 15642 50211725
Blood creatine phosphokinase increased 39.64 9.92 86 377671 26281 50201086
Gamma-glutamyltransferase increased 38.70 9.92 104 377653 29519 50197848
Angioedema 38.25 9.92 148 377609 37528 50189839
Unresponsive to stimuli 38.10 9.92 110 377647 30499 50196868
Drug level increased 37.93 9.92 53 377704 19215 50208152
Pre-eclampsia 37.73 9.92 139 377618 7905 50219462
Pain in jaw 37.71 9.92 153 377604 38275 50189092
Myocardial infarction 37.64 9.92 454 377303 88573 50138794
Ascites 37.62 9.92 139 377618 35722 50191645
Accidental overdose 37.20 9.92 55 377702 19478 50207889
Posterior reversible encephalopathy syndrome 37.08 9.92 34 377723 14894 50212473
Platelet count decreased 36.96 9.92 529 377228 100197 50127170
Metastases to liver 36.94 9.92 58 377699 20046 50207321
Abnormal behaviour 36.81 9.92 56 377701 19602 50207765
Nodule 36.70 9.92 235 377522 16768 50210599
Blood alkaline phosphatase increased 36.46 9.92 150 377607 37376 50189991
Ventricular septal defect 36.39 9.92 88 377669 3953 50223414
Joint stiffness 36.32 9.92 366 377391 29942 50197425
Deep vein thrombosis 36.09 9.92 361 377396 72943 50154424
Cerebral haemorrhage 36.08 9.92 94 377663 26958 50200409
Enthesopathy 36.03 9.92 127 377630 7066 50220301
Aspartate aminotransferase increased 36.00 9.92 390 377367 77608 50149759
Blood bilirubin increased 35.74 9.92 121 377636 31917 50195450
Dysgeusia 35.69 9.92 159 377598 38757 50188610
Blood pressure diastolic decreased 35.65 9.92 231 377526 16550 50210817
Polyarthritis 35.53 9.92 135 377622 7792 50219575
Bone pain 35.36 9.92 207 377550 47022 50180345
Injection site bruising 35.33 9.92 425 377332 36343 50191024
Localised infection 35.13 9.92 317 377440 25168 50202199
Disseminated intravascular coagulation 34.88 9.92 46 377711 17089 50210278
Flushing 34.70 9.92 326 377431 66689 50160678
Injection site rash 34.56 9.92 223 377534 15954 50211413
Maternal exposure before pregnancy 34.47 9.92 106 377651 5491 50221876
Intentional product use issue 34.43 9.92 784 376973 76134 50151233
Torsade de pointes 34.40 9.92 23 377734 11812 50215555
Pulmonary fibrosis 34.21 9.92 305 377452 24132 50203235
Blood calcium decreased 34.15 9.92 64 377693 20642 50206725
Palpitations 34.09 9.92 498 377259 94008 50133359
Vertigo 33.78 9.92 237 377520 51595 50175772
Arrhythmia 33.73 9.92 130 377627 33002 50194365
Device dislocation 33.45 9.92 69 377688 21477 50205890
Femur fracture 33.40 9.92 427 377330 37037 50190330
Brain oedema 33.39 9.92 26 377731 12344 50215023
Limb deformity 33.29 9.92 81 377676 3653 50223714
Infective pulmonary exacerbation of cystic fibrosis 33.11 9.92 9 377748 7900 50219467
Joint destruction 32.85 9.92 83 377674 3833 50223534
Tenderness 32.63 9.92 244 377513 18321 50209046
Premature delivery 32.44 9.92 294 377463 23369 50203998
Alanine aminotransferase increased 32.43 9.92 464 377293 87895 50139472
Dysarthria 32.42 9.92 156 377601 37247 50190120
Chronic kidney disease 32.12 9.92 170 377587 39601 50187766
Nightmare 31.91 9.92 44 377713 16042 50211325
Anaphylactic shock 31.76 9.92 64 377693 20091 50207276
Dysphagia 31.75 9.92 398 377359 77120 50150247
Akathisia 31.51 9.92 11 377746 8218 50219149
Musculoskeletal pain 31.47 9.92 733 377024 71444 50155923
C-reactive protein increased 31.47 9.92 683 377074 65791 50161576
Ventricular fibrillation 31.40 9.92 20 377737 10539 50216828
Inflammation 31.32 9.92 598 377159 56314 50171053
Premature rupture of membranes 31.31 9.92 90 377667 4490 50222877
Pleural effusion 31.23 9.92 424 377333 81030 50146337
Small for dates baby 31.21 9.92 76 377681 3429 50223938
Disability 31.00 9.92 182 377575 12593 50214774
Chest pain 30.82 9.92 1046 376711 175836 50051531
Haemorrhage 30.74 9.92 253 377504 53188 50174179
Ventricular tachycardia 30.67 9.92 44 377713 15777 50211590
Cytokine release syndrome 30.64 9.92 13 377744 8621 50218746
Neuroleptic malignant syndrome 30.55 9.92 23 377734 11107 50216260
Wrong technique in product usage process 30.49 9.92 266 377491 55244 50172123
Withdrawal syndrome 30.23 9.92 53 377704 17537 50209830
Respiratory distress 30.17 9.92 121 377636 30368 50196999
Tenosynovitis stenosans 29.92 9.92 57 377700 2167 50225200
Drug ineffective for unapproved indication 29.89 9.92 72 377685 21209 50206158
Psychotic disorder 29.70 9.92 75 377682 21737 50205630
Latent tuberculosis 29.57 9.92 57 377700 2186 50225181
Neurotoxicity 29.56 9.92 40 377717 14700 50212667
Smear cervix abnormal 29.45 9.92 64 377693 2677 50224690
Heart rate decreased 29.23 9.92 408 377349 36089 50191278
Diabetes mellitus inadequate control 29.17 9.92 33 377724 13112 50214255
Inappropriate antidiuretic hormone secretion 29.16 9.92 33 377724 13110 50214257
Pulmonary oedema 28.92 9.92 230 377527 48708 50178659
Toxic skin eruption 28.70 9.92 25 377732 11226 50216141
Synovial cyst 28.67 9.92 129 377628 8037 50219330
Joint range of motion decreased 28.51 9.92 236 377521 18276 50209091
Schizophrenia 28.13 9.92 10 377747 7387 50219980
International normalised ratio increased 27.78 9.92 198 377559 42954 50184413
Coagulopathy 27.41 9.92 58 377699 17886 50209481
Acute respiratory failure 27.37 9.92 116 377641 28666 50198701
Gastrointestinal haemorrhage 27.27 9.92 384 377373 72937 50154430
Tenosynovitis 27.27 9.92 153 377604 10412 50216955
Blood pressure diastolic increased 27.20 9.92 119 377638 7324 50220043
Laryngitis 27.18 9.92 157 377600 10799 50216568
Eosinophilia 27.08 9.92 62 377695 18590 50208777
Melaena 26.97 9.92 106 377651 26758 50200609
Irritability 26.76 9.92 115 377642 28311 50199056
Device difficult to use 26.41 9.92 21 377736 9865 50217502
Atrial fibrillation 26.23 9.92 569 377188 101176 50126191
Pain in extremity 26.17 9.92 2371 375386 270494 49956873
Hypomagnesaemia 26.14 9.92 87 377670 23069 50204298
Dysmorphism 26.08 9.92 53 377704 2114 50225253
Cerebrovascular accident 26.03 9.92 524 377233 94156 50133211
Parkinsonism 25.97 9.92 17 377740 8830 50218537
Wheelchair user 25.96 9.92 89 377668 4883 50222484
Pulmonary hypertension 25.80 9.92 145 377612 33272 50194095
Mania 25.79 9.92 26 377731 10890 50216477
Bradyphrenia 25.76 9.92 7 377750 6145 50221222
Crying 25.68 9.92 73 377684 20343 50207024
Atrioventricular block complete 25.63 9.92 11 377746 7244 50220123
Dyskinesia 25.45 9.92 114 377643 27747 50199620
Metastases to central nervous system 25.39 9.92 28 377729 11254 50216113
Polyneuropathy 25.27 9.92 32 377725 12099 50215268
Drug tolerance decreased 25.22 9.92 135 377622 9025 50218342
Skin ulcer 25.21 9.92 387 377370 34931 50192436
Arthritis infective 25.09 9.92 95 377662 5474 50221893
Asphyxia 25.05 9.92 5 377752 5422 50221945
Skin papilloma 25.04 9.92 79 377678 4150 50223217
Transplant rejection 24.94 9.92 21 377736 9588 50217779
Neck mass 24.89 9.92 68 377689 3293 50224074
Jaundice 24.83 9.92 107 377650 26322 50201045
Sepsis 24.82 9.92 779 376978 132146 50095221
Stress cardiomyopathy 24.77 9.92 14 377743 7873 50219494
Malignant melanoma 24.53 9.92 144 377613 9964 50217403
Bronchospasm 24.42 9.92 46 377711 14808 50212559
Obstructive airways disorder 24.41 9.92 50 377707 15602 50211765
Thrombotic microangiopathy 24.34 9.92 18 377739 8773 50218594
Device use error 24.00 9.92 5 377752 5261 50222106
Ischaemic stroke 23.98 9.92 52 377705 15896 50211471
Oedema peripheral 23.94 9.92 950 376807 157011 50070356
Face oedema 23.78 9.92 62 377695 17777 50209590
Developmental hip dysplasia 23.77 9.92 38 377719 1253 50226114
Back pain 23.70 9.92 1372 376385 218658 50008709
Paralysis 23.66 9.92 18 377739 8646 50218721
Immune reconstitution inflammatory syndrome 23.62 9.92 6 377751 5510 50221857
Blood potassium decreased 23.55 9.92 170 377587 36775 50190592
Placental disorder 23.52 9.92 40 377717 1390 50225977
Haematotoxicity 23.41 9.92 15 377742 7880 50219487
Aggression 23.38 9.92 80 377677 21036 50206331
Oropharyngeal pain 23.37 9.92 753 377004 77048 50150319
Synovial fluid analysis 23.30 9.92 43 377714 1595 50225772
Blood creatinine increased 23.24 9.92 414 377343 75746 50151621
Pyrexia 23.24 9.92 2484 375273 377719 49849648
Pancreatitis acute 23.24 9.92 95 377662 23717 50203650
Febrile bone marrow aplasia 23.22 9.92 9 377748 6302 50221065
Accidental exposure to product 23.13 9.92 91 377666 22966 50204401
Rotator cuff repair 23.11 9.92 44 377713 1672 50225695
Acute myeloid leukaemia 22.79 9.92 49 377708 15025 50212342
Spinal stenosis 22.64 9.92 176 377581 13374 50213993
Acute generalised exanthematous pustulosis 22.63 9.92 20 377737 8918 50218449
Polyhydramnios 22.58 9.92 48 377709 1977 50225390
Agranulocytosis 22.49 9.92 83 377674 21338 50206029
Product dose omission issue 22.47 9.92 1132 376625 182706 50044661
Macular degeneration 22.40 9.92 46 377711 14342 50213025
Graft versus host disease 22.34 9.92 9 377748 6157 50221210
Hypervolaemia 22.30 9.92 106 377651 25393 50201974
Dystonia 22.30 9.92 34 377723 11892 50215475
Fear 22.24 9.92 47 377710 14502 50212865
Tumour lysis syndrome 22.14 9.92 14 377743 7407 50219960
Second primary malignancy 22.11 9.92 12 377745 6902 50220465
Depressed mood 21.96 9.92 156 377601 33867 50193500
Myoclonus 21.91 9.92 47 377710 14423 50212944
Abdominal pain 21.81 9.92 1494 376263 234734 49992633
Unevaluable event 21.79 9.92 229 377528 45837 50181530
Confusional state 21.74 9.92 1150 376607 184778 50042589
Miosis 21.61 9.92 10 377747 6300 50221067
Panic attack 21.60 9.92 73 377684 19269 50208098
Loose body in joint 21.59 9.92 35 377722 1168 50226199
Complication of device insertion 21.59 9.92 9 377748 6032 50221335
Cardiac failure acute 21.45 9.92 18 377739 8232 50219135
Postoperative wound infection 21.39 9.92 122 377635 8353 50219014
COVID-19 21.25 9.92 234 377523 46428 50180939
Muscular weakness 21.25 9.92 543 377214 94470 50132897
Stomatitis 21.13 9.92 942 376815 100402 50126965
Hypomania 21.11 9.92 4 377753 4501 50222866
Abdominal distension 21.09 9.92 400 377357 72503 50154864
Pulmonary tuberculosis 21.02 9.92 75 377682 4198 50223169
Cardiogenic shock 20.95 9.92 54 377703 15545 50211822
Hemiparesis 20.84 9.92 78 377679 19970 50207397
Substance abuse 20.80 9.92 3 377754 4121 50223246
Tachypnoea 20.73 9.92 49 377708 14528 50212839
Therapeutic response decreased 20.69 9.92 480 377277 46751 50180616
Cytopenia 20.62 9.92 21 377736 8754 50218613
Lethargy 20.53 9.92 253 377504 49179 50178188
Pancreatitis 20.50 9.92 211 377546 42403 50184964
Product adhesion issue 20.37 9.92 4 377753 4388 50222979
Complication associated with device 20.25 9.92 50 377707 14605 50212762
Gastroenteritis viral 20.22 9.92 222 377535 18564 50208803
Genital haemorrhage 20.17 9.92 12 377745 6562 50220805
Body temperature decreased 20.13 9.92 199 377558 16196 50211171
Metastases to lung 20.05 9.92 32 377725 10988 50216379
Anhedonia 19.97 9.92 25 377732 9499 50217868
Joint dislocation 19.95 9.92 159 377598 12174 50215193
Atrial septal defect 19.93 9.92 97 377660 6244 50221123
Injection site warmth 19.89 9.92 174 377583 13692 50213675
Erythema multiforme 19.78 9.92 23 377734 9027 50218340
Haemorrhage intracranial 19.75 9.92 39 377718 12335 50215032
Cushingoid 19.72 9.92 100 377657 6545 50220822
Herpes zoster 19.70 9.92 679 377078 70107 50157260
Acute graft versus host disease 19.69 9.92 3 377754 3955 50223412
Dementia 19.53 9.92 58 377699 15939 50211428
Rash maculo-papular 19.29 9.92 118 377639 26523 50200844
Uterine perforation 19.28 9.92 12 377745 6403 50220964
Stevens-Johnson syndrome 19.27 9.92 90 377667 21662 50205705
Body height below normal 19.24 9.92 44 377713 1905 50225462
Nervousness 19.23 9.92 124 377633 27527 50199840
Status epilepticus 19.11 9.92 45 377712 13361 50214006
Disease recurrence 19.05 9.92 81 377676 20000 50207367
Acute chest syndrome 19.02 9.92 24 377733 633 50226734
Psychomotor hyperactivity 18.90 9.92 25 377732 9276 50218091
Foetal death 18.87 9.92 115 377642 8065 50219302
Subdural haematoma 18.83 9.92 43 377714 12904 50214463
Tardive dyskinesia 18.78 9.92 16 377741 7263 50220104
Cholecystitis chronic 18.63 9.92 27 377730 9642 50217725
Red blood cell sedimentation rate 18.56 9.92 64 377693 3522 50223845
Shock haemorrhagic 18.46 9.92 21 377736 8323 50219044
Urinary retention 18.44 9.92 117 377640 26073 50201294
Foetal anticonvulsant syndrome 18.34 9.92 22 377735 550 50226817
Maternal exposure timing unspecified 18.21 9.92 64 377693 3556 50223811
Glycosylated haemoglobin increased 18.19 9.92 32 377725 10574 50216793
Plasma cell myeloma 18.14 9.92 148 377609 31174 50196193
Off label use 18.11 9.92 3191 374566 471235 49756132
Joint injury 18.03 9.92 245 377512 21544 50205823
Congenital arterial malformation 18.00 9.92 17 377740 320 50227047
Infusion site pain 17.96 9.92 41 377716 12305 50215062
Hallucination, auditory 17.83 9.92 33 377724 10695 50216672
Lymphocyte count decreased 17.78 9.92 119 377638 26188 50201179
Haemophagocytic lymphohistiocytosis 17.75 9.92 23 377734 8610 50218757
Headache 17.70 9.92 3423 374334 503112 49724255
Exposure to toxic agent 17.68 9.92 3 377754 3655 50223712
Joint noise 17.68 9.92 63 377694 3524 50223843
Antinuclear antibody positive 17.65 9.92 93 377664 6179 50221188
Clear cell renal cell carcinoma 17.64 9.92 32 377725 1171 50226196
Proteinuria 17.62 9.92 64 377693 16533 50210834
Labelled drug-drug interaction medication error 17.62 9.92 32 377725 10445 50216922
Paradoxical drug reaction 17.61 9.92 3 377754 3644 50223723
Salivary hypersecretion 17.61 9.92 14 377743 6577 50220790
Myocarditis 17.58 9.92 20 377737 7927 50219440
Hyperlipidaemia 17.56 9.92 69 377688 17421 50209946
Crohn's disease 17.55 9.92 76 377681 4657 50222710
Fear of injection 17.52 9.92 91 377666 6012 50221355
Acidosis 17.41 9.92 31 377726 10196 50217171
Sinus tachycardia 17.40 9.92 91 377666 21263 50206104
Skin cancer 17.38 9.92 125 377632 9269 50218098
Hypertransaminasaemia 17.37 9.92 3 377754 3608 50223759
Haemorrhage in pregnancy 17.34 9.92 39 377718 1670 50225697
Synovial disorder 17.28 9.92 27 377730 873 50226494
Dactylitis 17.27 9.92 41 377716 1820 50225547
Fracture 17.25 9.92 197 377560 16636 50210731
Infusion site erythema 17.18 9.92 24 377733 8703 50218664
Ketoacidosis 17.14 9.92 4 377753 3891 50223476
Myopathy 17.14 9.92 26 377731 9113 50218254
Gestational hypertension 17.14 9.92 45 377712 2128 50225239
Oral herpes 17.13 9.92 233 377524 20492 50206875
Breast feeding 17.06 9.92 26 377731 822 50226545
Scleritis 17.06 9.92 58 377699 3169 50224198
Atrioventricular block 17.01 9.92 14 377743 6464 50220903
Complication of device removal 16.95 9.92 5 377752 4159 50223208
Multiple allergies 16.94 9.92 23 377734 8440 50218927
Lupus-like syndrome 16.82 9.92 125 377632 9366 50218001
Fracture delayed union 16.81 9.92 46 377711 2230 50225137
Hypophosphataemia 16.71 9.92 23 377734 8391 50218976
Incorrect route of product administration 16.68 9.92 77 377680 18589 50208778
Haemoptysis 16.63 9.92 117 377640 25456 50201911
Tubulointerstitial nephritis 16.59 9.92 58 377699 15153 50212214
Stillbirth 16.57 9.92 88 377669 5864 50221503
Clostridium difficile colitis 16.56 9.92 72 377685 17670 50209697
Mood altered 16.56 9.92 45 377712 12728 50214639
Device related infection 16.54 9.92 89 377668 20646 50206721
Hepatotoxicity 16.53 9.92 127 377630 27099 50200268
Leukocytosis 16.35 9.92 100 377657 22479 50204888
Talipes 16.33 9.92 34 377723 1380 50225987
Hallucination, visual 16.28 9.92 66 377691 16516 50210851
Wheezing 16.28 9.92 346 377411 61701 50165666
Oedema 16.25 9.92 399 377358 69782 50157585
Bone marrow failure 16.24 9.92 130 377627 27494 50199873
Pharyngitis streptococcal 16.18 9.92 117 377640 8691 50218676
Dry skin 16.13 9.92 226 377531 42965 50184402
Cerebral infarction 16.00 9.92 95 377662 21509 50205858
Generalised oedema 15.90 9.92 51 377706 13680 50213687
Dislocation of vertebra 15.89 9.92 55 377702 3032 50224335
Hyperprolactinaemia 15.75 9.92 3 377754 3362 50224005
Catheter site erythema 15.69 9.92 5 377752 3957 50223410
Exomphalos 15.69 9.92 20 377737 533 50226834
Hypophagia 15.61 9.92 132 377625 27596 50199771
Temperature regulation disorder 15.60 9.92 6 377751 4221 50223146
Skin exfoliation 15.53 9.92 168 377589 33444 50193923
Gastrointestinal disorder 15.53 9.92 858 376899 93598 50133769
Squamous cell carcinoma 15.51 9.92 105 377652 7634 50219733
Delusion 15.45 9.92 35 377722 10534 50216833
Pulmonary congestion 15.41 9.92 60 377697 15187 50212180
Cardiomyopathy 15.33 9.92 62 377695 15524 50211843
Pathogen resistance 15.30 9.92 12 377745 5677 50221690
Aspergillus infection 15.27 9.92 17 377740 6804 50220563
Mouth ulceration 15.26 9.92 294 377463 27730 50199637
Multiple sclerosis 15.24 9.92 90 377667 20403 50206964
Neonatal respiratory distress syndrome 15.19 9.92 49 377708 2605 50224762
Blood glucose decreased 15.18 9.92 77 377680 18134 50209233
Affective disorder 15.15 9.92 10 377747 5171 50222196
Injection site haematoma 15.14 9.92 87 377670 5973 50221394
Human antichimeric antibody positive 15.13 9.92 34 377723 1455 50225912
Haematoma 15.12 9.92 150 377607 30360 50197007
Aphasia 15.01 9.92 138 377619 28356 50199011
Immunodeficiency 14.95 9.92 173 377584 14655 50212712
Vascular device infection 14.93 9.92 7 377750 4377 50222990
Infusion site swelling 14.88 9.92 19 377738 7157 50220210
Colitis microscopic 14.87 9.92 16 377741 6504 50220863
Bronchopulmonary aspergillosis 14.83 9.92 21 377736 7571 50219796
Oliguria 14.82 9.92 24 377733 8192 50219175
Diabetes mellitus 14.81 9.92 267 377490 48766 50178601
Blood iron increased 14.76 9.92 32 377725 1336 50226031
Bone disorder 14.76 9.92 209 377548 18543 50208824
Respiration abnormal 14.71 9.92 10 377747 5092 50222275
Polyuria 14.61 9.92 19 377738 7102 50220265
Cyanosis 14.56 9.92 61 377696 15123 50212244
Right ventricular failure 14.53 9.92 65 377692 15828 50211539
Joint lock 14.52 9.92 41 377716 2024 50225343
Malaise 14.49 9.92 2241 375516 333291 49894076
Catheter site pain 14.46 9.92 5 377752 3757 50223610
Antibody test positive 14.45 9.92 44 377713 2267 50225100
Poor venous access 14.44 9.92 129 377628 10211 50217156
Pericardial effusion 14.33 9.92 122 377635 25467 50201900
Anuria 14.29 9.92 40 377717 11204 50216163
Speech disorder developmental 14.28 9.92 20 377737 585 50226782
Rash erythematous 14.24 9.92 179 377578 34673 50192694
Sleep apnoea syndrome 14.18 9.92 112 377645 23756 50203611
Muscle twitching 14.18 9.92 63 377694 15368 50211999
Angina pectoris 14.15 9.92 126 377631 26062 50201305
Product prescribing error 14.07 9.92 95 377662 20866 50206501
Cyst 14.04 9.92 146 377611 12041 50215326
Cholestasis of pregnancy 14.01 9.92 28 377729 1103 50226264
Muscle rigidity 14.01 9.92 33 377724 9796 50217571
Foot fracture 13.90 9.92 219 377538 19872 50207495
Tendonitis 13.89 9.92 188 377569 16517 50210850
Renal injury 13.86 9.92 27 377730 8584 50218783
Surgery 13.86 9.92 309 377448 29896 50197471
Immunosuppression 13.85 9.92 99 377658 7327 50220040
Bradypnoea 13.84 9.92 3 377754 3071 50224296
Lip swelling 13.82 9.92 118 377639 24618 50202749
Device breakage 13.65 9.92 32 377725 9515 50217852
Mental disorder 13.63 9.92 102 377655 21889 50205478
Hot flush 13.50 9.92 240 377517 43929 50183438
Bundle branch block left 13.44 9.92 16 377741 6214 50221153
Hepatic cytolysis 13.40 9.92 25 377732 8078 50219289
Autism spectrum disorder 13.37 9.92 21 377736 682 50226685
Dysuria 13.36 9.92 142 377615 28362 50199005
Hypertelorism 13.31 9.92 16 377741 401 50226966
Hallucinations, mixed 13.30 9.92 7 377750 4096 50223271
Foetal distress syndrome 13.30 9.92 29 377728 1216 50226151
Aspiration 13.28 9.92 31 377726 9233 50218134
Tumour marker increased 13.28 9.92 6 377751 3834 50223533
Wound infection 13.28 9.92 144 377613 12004 50215363
Serum ferritin increased 13.20 9.92 75 377682 5127 50222240
Pseudomonas infection 13.17 9.92 32 377725 9398 50217969
Product substitution issue 13.15 9.92 57 377700 14000 50213367
Myelosuppression 13.15 9.92 54 377703 13463 50213904
Induced labour 13.01 9.92 24 377733 890 50226477
Klebsiella infection 12.99 9.92 21 377736 7173 50220194
Hyperthyroidism 12.89 9.92 47 377710 12128 50215239
Cervical incompetence 12.89 9.92 19 377738 583 50226784
Tongue disorder 12.89 9.92 115 377642 9101 50218266
Colitis 12.87 9.92 206 377551 38323 50189044
Coronary artery disease 12.78 9.92 151 377606 29575 50197792
Visual impairment 12.76 9.92 400 377357 67875 50159492
Occult blood 12.76 9.92 28 377729 1179 50226188
Influenza 12.75 9.92 803 376954 88735 50138632
Toxic epidermal necrolysis 12.71 9.92 98 377659 20894 50206473
Abdominal pain upper 12.69 9.92 1020 376737 158289 50069078
Maternal exposure during breast feeding 12.64 9.92 53 377704 3201 50224166
Anger 12.50 9.92 43 377714 11290 50216077
Ankylosing spondylitis 12.49 9.92 94 377663 7071 50220296
Acute myocardial infarction 12.47 9.92 149 377608 29124 50198243
Respiratory acidosis 12.46 9.92 16 377741 6012 50221355
Transplant dysfunction 12.45 9.92 10 377747 4674 50222693
Dermatitis exfoliative 12.43 9.92 12 377745 5130 50222237
Ulcer 12.42 9.92 216 377541 19984 50207383
Joint warmth 12.38 9.92 30 377727 1349 50226018
Eating disorder 12.37 9.92 66 377691 15343 50212024
Malignant mediastinal neoplasm 12.36 9.92 18 377739 546 50226821
Lymphatic fistula 12.36 9.92 21 377736 729 50226638
Drug-induced liver injury 12.36 9.92 142 377615 27953 50199414
Pulseless electrical activity 12.32 9.92 20 377737 6821 50220546
Product complaint 12.32 9.92 44 377713 11422 50215945
Pneumonia viral 12.29 9.92 20 377737 6814 50220553
Arthritis bacterial 12.27 9.92 78 377679 5551 50221816
Polydipsia 12.27 9.92 4 377753 3120 50224247
Drug abuser 12.26 9.92 3 377754 2825 50224542
Bundle branch block right 12.24 9.92 10 377747 4635 50222732
Intervertebral disc degeneration 12.24 9.92 154 377603 13307 50214060
Urinary incontinence 12.24 9.92 143 377614 28065 50199302
Visual acuity reduced 12.20 9.92 94 377663 20045 50207322
Femoral hernia incarcerated 12.14 9.92 21 377736 740 50226627
Epstein-Barr virus infection 12.10 9.92 21 377736 6976 50220391
Swollen tongue 12.09 9.92 146 377611 28484 50198883
Purpura 12.05 9.92 36 377721 9875 50217492
Human anti-human antibody test 12.05 9.92 15 377742 390 50226977
Product preparation error 12.04 9.92 9 377748 4363 50223004
Sinus bradycardia 12.00 9.92 54 377703 13129 50214238
Systemic inflammatory response syndrome 11.96 9.92 12 377745 5037 50222330
Lymphoedema 11.93 9.92 32 377725 9090 50218277
Injection site irritation 11.90 9.92 64 377693 4286 50223081
Blood loss anaemia 11.86 9.92 27 377730 8112 50219255
Circulatory collapse 11.81 9.92 94 377663 19906 50207461
Personality disorder 11.78 9.92 9 377748 4315 50223052
Wound infection pseudomonas 11.76 9.92 28 377729 1245 50226122
Tendon disorder 11.76 9.92 74 377683 5248 50222119
Pregnancy with contraceptive device 11.76 9.92 8 377749 4071 50223296
Multiple-drug resistance 11.74 9.92 5 377752 3309 50224058
Therapy change 11.72 9.92 13 377744 5212 50222155
Hereditary angioedema 11.71 9.92 14 377743 5428 50221939
Patent ductus arteriosus 11.70 9.92 58 377699 3762 50223605
Endodontic procedure 11.68 9.92 46 377711 2700 50224667
Pulmonary haemorrhage 11.67 9.92 19 377738 6473 50220894
Potentiating drug interaction 11.66 9.92 7 377750 3809 50223558
Amylase increased 11.65 9.92 14 377743 5416 50221951
Abortion missed 11.63 9.92 32 377725 1556 50225811
Sexual dysfunction 11.61 9.92 5 377752 3287 50224080
Paranoia 11.59 9.92 39 377718 10309 50217058
Treatment noncompliance 11.53 9.92 157 377600 29993 50197374
Acute pulmonary oedema 11.51 9.92 23 377734 7244 50220123
Pancreatic steatosis 11.51 9.92 23 377734 906 50226461
Abnormal dreams 11.45 9.92 34 377723 9343 50218024
Bone lesion 11.45 9.92 13 377744 5157 50222210
Affect lability 11.44 9.92 32 377725 8966 50218401
Abortion threatened 11.43 9.92 17 377740 526 50226841
Bone density abnormal 11.37 9.92 49 377708 2996 50224371
Bronchitis 11.36 9.92 914 376843 103245 50124122
Cardiotoxicity 11.34 9.92 22 377735 7005 50220362
Somnambulism 11.33 9.92 12 377745 4912 50222455
Pancytopenia 11.31 9.92 750 377007 83280 50144087
Ingrown hair 11.30 9.92 16 377741 473 50226894
Carpal tunnel syndrome 11.25 9.92 183 377574 16710 50210657
Adverse event 11.24 9.92 416 377341 43347 50184020
Anterior chamber cleavage syndrome 11.23 9.92 10 377747 174 50227193
Catatonia 11.21 9.92 7 377750 3729 50223638
Peripheral sensory neuropathy 11.20 9.92 20 377737 6571 50220796
Plasma cell myeloma recurrent 11.17 9.92 3 377754 2655 50224712
Paraesthesia 11.16 9.92 760 376997 119483 50107884
Hepatitis acute 11.13 9.92 27 377730 7934 50219433
Learning disorder 11.12 9.92 18 377739 600 50226767
Crystal nephropathy 11.10 9.92 21 377736 794 50226573
Rheumatoid lung 11.06 9.92 42 377715 2423 50224944
Food allergy 11.06 9.92 28 377729 8109 50219258
Taste disorder 11.04 9.92 29 377728 8295 50219072
Inflammatory marker increased 11.03 9.92 76 377681 5558 50221809
Bradykinesia 11.01 9.92 8 377749 3935 50223432
Body temperature increased 11.00 9.92 166 377591 31175 50196192
Product administered to patient of inappropriate age 11.00 9.92 3 377754 2627 50224740
Troponin increased 10.98 9.92 28 377729 8090 50219277
Infusion site pruritus 10.98 9.92 8 377749 3929 50223438
Renal disorder 10.96 9.92 142 377615 27363 50200004
Renal tubular necrosis 10.93 9.92 39 377718 10129 50217238
Knee operation 10.92 9.92 68 377689 4805 50222562
Pemphigoid 10.89 9.92 17 377740 5890 50221477
Forceps delivery 10.82 9.92 10 377747 183 50227184
Pleuritic pain 10.81 9.92 84 377673 6382 50220985
Eosinophil count increased 10.79 9.92 32 377725 8798 50218569
Presyncope 10.76 9.92 122 377635 24076 50203291
Lung adenocarcinoma 10.76 9.92 60 377697 4074 50223293
Drug screen positive 10.74 9.92 6 377751 3396 50223971
Abortion incomplete 10.63 9.92 5 377752 3121 50224246
Myofascial pain syndrome 10.63 9.92 37 377720 2046 50225321
Product physical issue 10.60 9.92 10 377747 4322 50223045
Alanine aminotransferase abnormal 10.60 9.92 60 377697 4096 50223271
Placental insufficiency 10.59 9.92 27 377730 1254 50226113
Trigeminal neuralgia 10.57 9.92 5 377752 3110 50224257
Inadequate analgesia 10.54 9.92 3 377754 2555 50224812
Ataxia 10.54 9.92 60 377697 13726 50213641
Embedded device 10.51 9.92 4 377753 2833 50224534
Mobility decreased 10.48 9.92 712 377045 79236 50148131
Stress at work 10.47 9.92 24 377733 1041 50226326
Exostosis 10.46 9.92 133 377624 11520 50215847
Chondropathy 10.45 9.92 37 377720 2063 50225304
Nail injury 10.45 9.92 15 377742 449 50226918
Lung transplant 10.44 9.92 4 377753 2821 50224546
Lymphadenectomy 10.42 9.92 22 377735 902 50226465
Device issue 10.40 9.92 97 377660 19875 50207492
Progressive multifocal leukoencephalopathy 10.39 9.92 47 377710 11410 50215957
Threatened labour 10.38 9.92 20 377737 767 50226600
Ankyloglossia congenital 10.34 9.92 10 377747 194 50227173
Head injury 10.33 9.92 122 377635 23898 50203469
Ileus paralytic 10.33 9.92 9 377748 4041 50223326
Vacuum extractor delivery 10.32 9.92 9 377748 152 50227215
Nystagmus 10.26 9.92 16 377741 5545 50221822
Congenital hydronephrosis 10.24 9.92 14 377743 400 50226967
Pulmonary alveolar haemorrhage 10.21 9.92 9 377748 4018 50223349
Intracranial pressure increased 10.19 9.92 10 377747 4242 50223125
Hyperuricaemia 10.11 9.92 12 377745 4668 50222699
Oxygen consumption increased 10.11 9.92 7 377750 3529 50223838
Incoherent 10.08 9.92 10 377747 4220 50223147
Acute coronary syndrome 10.05 9.92 36 377721 9338 50218029
Toxic encephalopathy 10.05 9.92 16 377741 5499 50221868
Retinitis 10.05 9.92 34 377723 1853 50225514
Cardiac disorder 10.04 9.92 244 377513 42735 50184632
Chills 10.02 9.92 605 377152 96082 50131285
Hepatitis cholestatic 10.00 9.92 19 377738 6098 50221269
Retrognathia 9.98 9.92 14 377743 410 50226957

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 523.61 9.84 692 135643 31460 29406732
Drug abuse 302.53 9.84 16 136319 79867 29358325
Foetal exposure during pregnancy 299.29 9.84 550 135785 33317 29404875
Toxicity to various agents 225.31 9.84 282 136053 173379 29264813
Arthralgia 220.06 9.84 1243 135092 138374 29299818
Completed suicide 204.54 9.84 80 136255 90166 29348026
Psoriatic arthropathy 154.94 9.84 258 136077 14433 29423759
Dysmorphism 130.82 9.84 109 136226 2862 29435330
Drug interaction 116.66 9.84 491 135844 196894 29241298
Joint swelling 107.68 9.84 484 135851 49146 29389046
Sickle cell anaemia with crisis 107.27 9.84 92 136243 2516 29435676
Premature baby 101.15 9.84 237 136098 17043 29421149
Psoriasis 88.54 9.84 338 135997 31889 29406303
Enthesopathy 87.76 9.84 97 136238 3646 29434546
Exposure during pregnancy 84.59 9.84 146 136189 8408 29429784
Intentional overdose 84.23 9.84 36 136299 38492 29399700
Speech disorder developmental 77.88 9.84 67 136268 1840 29436352
Neonatal respiratory distress syndrome 73.01 9.84 89 136246 3721 29434471
Tenosynovitis 72.84 9.84 88 136247 3645 29434547
Acute kidney injury 71.01 9.84 832 135503 264435 29173757
Blood pressure fluctuation 70.51 9.84 227 136108 19667 29418525
Musculoskeletal stiffness 67.96 9.84 347 135988 37111 29401081
Atrial septal defect 65.99 9.84 115 136220 6674 29431518
Hypospadias 65.60 9.84 75 136260 2927 29435265
Foetal anticonvulsant syndrome 64.75 9.84 49 136286 1115 29437077
Death 61.71 9.84 1159 135176 340925 29097267
Nasopharyngitis 59.72 9.84 475 135860 59190 29379002
Drug reaction with eosinophilia and systemic symptoms 58.30 9.84 28 136307 27964 29410228
Pain 58.10 9.84 1111 135224 170321 29267871
Synovitis 57.98 9.84 144 136191 10746 29427446
Maternal drugs affecting foetus 57.53 9.84 80 136255 3813 29434379
Autism spectrum disorder 57.12 9.84 58 136277 1974 29436218
Maternal exposure during pregnancy 56.90 9.84 82 136253 4041 29434151
Overdose 56.56 9.84 184 136151 79635 29358557
Low birth weight baby 54.18 9.84 104 136231 6504 29431688
Small for dates baby 52.07 9.84 73 136262 3506 29434686
C-reactive protein abnormal 51.32 9.84 101 136234 6435 29431757
Learning disorder 50.27 9.84 40 136295 982 29437210
Cryptorchism 50.21 9.84 53 136282 1889 29436303
Suicide attempt 50.00 9.84 50 136285 34060 29404132
Hypoglycaemia neonatal 49.91 9.84 50 136285 1674 29436518
Product use in unapproved indication 49.42 9.84 219 136116 86656 29351536
Hepatic function abnormal 48.45 9.84 66 136269 39193 29398999
Serotonin syndrome 47.82 9.84 11 136324 17501 29420691
Arthritis 46.94 9.84 234 136101 24785 29413407
Coma 46.04 9.84 69 136266 39381 29398811
Drug resistance 45.69 9.84 21 136314 21519 29416673
Tongue disorder 45.67 9.84 79 136256 4557 29433635
Ventricular septal defect 45.54 9.84 68 136267 3461 29434731
Maternal exposure during breast feeding 44.69 9.84 44 136291 1442 29436750
Rhabdomyolysis 44.60 9.84 138 136197 60670 29377522
Palmar-plantar erythrodysaesthesia syndrome 42.93 9.84 8 136327 14751 29423441
Foot deformity 41.64 9.84 70 136265 3945 29434247
Arthropathy 41.43 9.84 203 136132 21351 29416841
Febrile neutropenia 41.42 9.84 325 136010 111915 29326277
Syndactyly 39.56 9.84 31 136304 744 29437448
Basal cell carcinoma 38.98 9.84 168 136167 16742 29421450
Pulmonary fibrosis 38.41 9.84 158 136177 15424 29422768
Rheumatoid nodule 38.14 9.84 48 136287 2074 29436118
Developmental delay 37.59 9.84 52 136283 2466 29435726
Haemoglobin decreased 37.55 9.84 705 135630 107670 29330522
Intentional product misuse 37.26 9.84 64 136271 34597 29403595
Drug intolerance 36.92 9.84 363 135972 48016 29390176
Osteoarthritis 36.60 9.84 173 136162 17930 29420262
Drug dependence 36.58 9.84 26 136309 20955 29417237
Lower respiratory tract infection 36.47 9.84 228 136107 26274 29411918
Pancytopenia 36.44 9.84 562 135773 82606 29355586
Blood pressure systolic increased 36.29 9.84 164 136171 16681 29421511
Exposure via breast milk 36.11 9.84 42 136293 1670 29436522
Tendonitis 34.97 9.84 98 136237 7863 29430329
Joint laxity 34.59 9.84 22 136313 374 29437818
Congenital hand malformation 33.52 9.84 25 136310 556 29437636
Talipes 32.95 9.84 41 136294 1751 29436441
Bradycardia 32.91 9.84 173 136162 65456 29372736
Infusion related reaction 32.86 9.84 328 136007 43558 29394634
Alanine aminotransferase abnormal 32.61 9.84 53 136282 2904 29435288
Respiratory arrest 32.31 9.84 43 136292 25790 29412402
Jaundice neonatal 31.98 9.84 34 136301 1222 29436970
Hypermobility syndrome 31.55 9.84 20 136315 338 29437854
Blood pressure systolic abnormal 31.33 9.84 44 136291 2117 29436075
Intellectual disability 31.14 9.84 32 136303 1105 29437087
Blood pressure increased 30.92 9.84 495 135840 73308 29364884
Delirium 30.62 9.84 87 136248 39310 29398882
Foetal growth restriction 30.54 9.84 59 136276 3707 29434485
Renal failure 30.45 9.84 375 135960 118224 29319968
Language disorder 30.07 9.84 41 136294 1918 29436274
Angioedema 29.88 9.84 64 136271 31851 29406341
Joint effusion 29.69 9.84 62 136273 4122 29434070
Pain in extremity 29.33 9.84 691 135644 109742 29328450
Drug withdrawal syndrome 29.17 9.84 24 136311 17960 29420232
Off label use 28.38 9.84 1117 135218 299683 29138509
Cardiac failure 28.12 9.84 232 136103 79055 29359137
Large for dates baby 28.06 9.84 27 136308 860 29437332
Cytomegalovirus infection 27.67 9.84 40 136295 23175 29415017
Plagiocephaly 27.63 9.84 21 136314 481 29437711
Polyarthritis 27.46 9.84 58 136277 3887 29434305
Serum ferritin increased 26.75 9.84 71 136264 5517 29432675
Hyperbilirubinaemia neonatal 26.18 9.84 24 136311 718 29437474
Musculoskeletal pain 26.00 9.84 225 136110 28728 29409464
Skin cancer 25.92 9.84 92 136243 8376 29429816
Knee deformity 25.57 9.84 21 136314 540 29437652
Peripheral swelling 25.39 9.84 424 135911 63315 29374877
Suicidal ideation 25.29 9.84 79 136256 34637 29403555
Somnolence 25.29 9.84 294 136041 93661 29344531
Multiple organ dysfunction syndrome 25.05 9.84 179 136156 62937 29375255
Knee arthroplasty 25.02 9.84 71 136264 5738 29432454
Sedation 24.95 9.84 26 136309 17379 29420813
Caesarean section 24.73 9.84 37 136298 1886 29436306
Hand deformity 24.61 9.84 39 136296 2091 29436101
Loss of personal independence in daily activities 24.60 9.84 201 136134 25239 29412953
Motor developmental delay 24.57 9.84 22 136313 638 29437554
Dysgraphia 24.50 9.84 38 136297 2000 29436192
Psychotic disorder 24.33 9.84 35 136300 20319 29417873
Selective eating disorder 24.31 9.84 34 136301 1629 29436563
Hyperglycaemia 24.29 9.84 79 136256 34208 29403984
Depressed level of consciousness 24.22 9.84 88 136247 36854 29401338
Disease progression 24.16 9.84 251 136084 81665 29356527
Astigmatism 24.11 9.84 26 136309 950 29437242
Otitis media 24.05 9.84 43 136292 2546 29435646
Altered state of consciousness 23.97 9.84 34 136301 19855 29418337
Constipation 23.93 9.84 376 135959 113784 29324408
Hypoglycaemia 23.92 9.84 128 136207 48218 29389974
Behaviour disorder 23.83 9.84 52 136283 3564 29434628
Drug withdrawal syndrome neonatal 23.73 9.84 50 136285 3345 29434847
Agitation 23.66 9.84 139 136196 51165 29387027
Lactic acidosis 23.35 9.84 67 136268 30180 29408012
Urticaria 22.68 9.84 153 136182 54507 29383685
Cardiac arrest 22.58 9.84 269 136066 85322 29352870
Poisoning 22.38 9.84 9 136326 9984 29428208
Pathogen resistance 22.36 9.84 5 136330 8111 29430081
Strabismus 22.28 9.84 30 136305 1386 29436806
Hypotonia neonatal 22.23 9.84 28 136307 1211 29436981
Blood pressure diastolic decreased 22.10 9.84 77 136258 6945 29431247
Blood pressure diastolic abnormal 21.97 9.84 41 136294 2510 29435682
Body temperature decreased 21.62 9.84 102 136233 10562 29427630
Hydrocele 21.53 9.84 35 136300 1918 29436274
Substance abuse 21.26 9.84 3 136332 6784 29431408
Medical device implantation 21.07 9.84 19 136316 556 29437636
C-reactive protein increased 20.88 9.84 303 136032 43960 29394232
Shock 20.81 9.84 42 136293 21362 29416830
Anal fistula 20.80 9.84 54 136281 4141 29434051
Agitation neonatal 20.77 9.84 25 136310 1031 29437161
Dyslexia 20.77 9.84 15 136320 317 29437875
Crohn's disease 20.67 9.84 44 136291 2965 29435227
Dyspraxia 20.38 9.84 16 136319 385 29437807
Tuberculosis 20.18 9.84 76 136259 7120 29431072
Arthritis bacterial 20.05 9.84 55 136280 4358 29433834
Wound 19.98 9.84 109 136226 11954 29426238
Juvenile idiopathic arthritis 19.64 9.84 28 136307 1366 29436826
Foetal disorder 19.59 9.84 21 136314 762 29437430
Malignant melanoma 19.57 9.84 75 136260 7086 29431106
Attention deficit hyperactivity disorder 19.55 9.84 36 136299 2181 29436011
Heart rate decreased 19.52 9.84 188 136147 24724 29413468
Patent ductus arteriosus 19.48 9.84 44 136291 3087 29435105
Blood creatine phosphokinase increased 19.34 9.84 109 136226 40535 29397657
Congenital anomaly 19.19 9.84 27 136308 1301 29436891
Neuroleptic malignant syndrome 19.07 9.84 28 136307 16120 29422072
Post procedural infection 18.91 9.84 53 136282 4252 29433940
Lacrimal disorder 18.86 9.84 14 136321 309 29437883
Cleft lip 18.75 9.84 14 136321 312 29437880
Psychomotor retardation 18.72 9.84 42 136293 2934 29435258
Renal aplasia 18.70 9.84 19 136316 647 29437545
Congenital bladder anomaly 18.61 9.84 13 136322 260 29437932
Vitamin D deficiency 18.61 9.84 62 136273 5467 29432725
Bronchiolitis 18.59 9.84 40 136295 2715 29435477
Limb reduction defect 18.57 9.84 13 136322 261 29437931
Intentional self-injury 18.56 9.84 18 136317 12443 29425749
Weight decrease neonatal 18.48 9.84 14 136321 319 29437873
Back disorder 18.37 9.84 65 136270 5908 29432284
Renal impairment 18.37 9.84 264 136071 81069 29357123
Colitis ulcerative 18.28 9.84 111 136224 12658 29425534
Congenital foot malformation 18.25 9.84 15 136320 386 29437806
Acute hepatic failure 18.11 9.84 17 136318 11935 29426257
Rash maculo-papular 17.88 9.84 55 136280 24234 29413958
Blood pressure diastolic increased 17.81 9.84 47 136288 3639 29434553
Ankyloglossia congenital 17.63 9.84 13 136322 284 29437908
Haematocrit decreased 17.60 9.84 208 136127 28814 29409378
Umbilical hernia 17.42 9.84 47 136288 3688 29434504
Scoliosis 17.40 9.84 35 136300 2265 29435927
Nasal disorder 17.39 9.84 27 136308 1422 29436770
Haemangioma congenital 17.33 9.84 16 136319 483 29437709
Diaphragmatic disorder 17.31 9.84 22 136313 960 29437232
Electrocardiogram QT prolonged 17.15 9.84 97 136238 36040 29402152
Vitamin B12 deficiency 17.14 9.84 43 136292 3228 29434964
Weight decreased 17.09 9.84 855 135480 150050 29288142
Joint range of motion decreased 17.03 9.84 64 136271 5990 29432202
Lung neoplasm malignant 17.01 9.84 119 136216 14238 29423954
Ankylosing spondylitis 16.98 9.84 50 136285 4126 29434066
Diabetic ketoacidosis 16.98 9.84 30 136305 16043 29422149
Neck mass 16.95 9.84 27 136308 1454 29436738
Infective pulmonary exacerbation of cystic fibrosis 16.86 9.84 4 136331 6232 29431960
Microcephaly 16.83 9.84 19 136316 731 29437461
Status epilepticus 16.78 9.84 15 136320 10779 29427413
Spinal disorder 16.74 9.84 46 136289 3649 29434543
Hallucination 16.69 9.84 129 136206 44583 29393609
Multiple congenital abnormalities 16.67 9.84 16 136319 508 29437684
Joint stiffness 16.64 9.84 87 136248 9386 29428806
Arthrodesis 16.52 9.84 15 136320 443 29437749
Bradycardia neonatal 16.48 9.84 21 136314 919 29437273
Injection site pain 16.47 9.84 225 136110 32221 29405971
Hepatic failure 16.39 9.84 82 136253 31430 29406762
Pyrexia 16.37 9.84 1124 135211 286498 29151694
Respiratory disorder neonatal 16.34 9.84 26 136309 1399 29436793
Proteinuria 16.24 9.84 30 136305 15774 29422418
Polydactyly 16.21 9.84 23 136312 1117 29437075
Grip strength decreased 16.15 9.84 34 136301 2273 29435919
Inflammation 16.11 9.84 168 136167 22560 29415632
Pectus excavatum 16.10 9.84 11 136324 212 29437980
C-reactive protein decreased 16.03 9.84 27 136308 1524 29436668
Septic arthritis staphylococcal 15.84 9.84 15 136320 468 29437724
Hypertelorism 15.79 9.84 16 136319 543 29437649
Cellulitis 15.78 9.84 298 136037 45542 29392650
Neurotoxicity 15.69 9.84 27 136308 14586 29423606
Ear disorder 15.66 9.84 24 136311 1250 29436942
Red blood cell sedimentation rate increased 15.59 9.84 72 136263 7389 29430803
Haemangioma 15.56 9.84 28 136307 1666 29436526
Oesophageal fibrosis 15.42 9.84 10 136325 176 29438016
Respiratory rate increased 15.32 9.84 80 136255 8628 29429564
Immunodeficiency 15.13 9.84 50 136285 4390 29433802
Maternal exposure timing unspecified 14.99 9.84 13 136322 361 29437831
Poor venous access 14.97 9.84 40 136295 3121 29435071
Therapeutic product effect decreased 14.85 9.84 204 136131 29247 29408945
Infection 14.85 9.84 461 135874 76290 29361902
No adverse event 14.78 9.84 37 136298 17441 29420751
Finger deformity 14.76 9.84 22 136313 1118 29437074
Arnold-Chiari malformation 14.63 9.84 12 136323 308 29437884
Prostate cancer 14.62 9.84 181 136154 25346 29412846
Contraindicated product administered 14.39 9.84 138 136197 18128 29420064
Diverticular perforation 14.37 9.84 38 136297 2946 29435246
Hernia pain 14.36 9.84 11 136324 255 29437937
Inguinal hernia 14.32 9.84 65 136270 6623 29431569
Injection site bruising 14.28 9.84 71 136264 7509 29430683
Venoocclusive liver disease 14.28 9.84 7 136328 6910 29431282
Emphysema 14.12 9.84 78 136257 8593 29429599
Foetal distress syndrome 13.98 9.84 20 136315 979 29437213
Foetal heart rate deceleration abnormality 13.82 9.84 14 136321 475 29437717
Vascular insufficiency 13.81 9.84 12 136323 334 29437858
Blood parathyroid hormone decreased 13.80 9.84 18 136317 806 29437386
Respiratory failure 13.65 9.84 342 135993 96789 29341403
Oropharyngeal pain 13.62 9.84 200 136135 29085 29409107
Anal atresia 13.59 9.84 11 136324 277 29437915
Spina bifida 13.57 9.84 12 136323 342 29437850
Cerebral haemorrhage 13.52 9.84 87 136248 31339 29406853
Incorrect route of product administration 13.48 9.84 18 136317 10783 29427409
Pleural fibrosis 13.48 9.84 23 136312 1312 29436880
Tooth malformation 13.47 9.84 9 136326 167 29438025
Blood insulin increased 13.43 9.84 12 136323 347 29437845
Radiation inflammation 13.42 9.84 10 136325 222 29437970
Peripheral artery thrombosis 13.40 9.84 30 136305 2092 29436100
Pneumonia 13.39 9.84 1678 134657 318494 29119698
Ear infection 13.28 9.84 73 136262 8027 29430165
Product quality issue 13.17 9.84 34 136301 15861 29422331
Anaphylactic shock 13.11 9.84 26 136309 13310 29424882
Developmental coordination disorder 13.06 9.84 9 136326 176 29438016
Ear malformation 12.91 9.84 11 136324 298 29437894
Hyperammonaemia 12.84 9.84 5 136330 5658 29432534
Congenital hydronephrosis 12.79 9.84 16 136319 687 29437505
Oxygen saturation decreased 12.78 9.84 284 136051 44653 29393539
Unresponsive to stimuli 12.72 9.84 66 136269 25060 29413132
Arthritis infective 12.64 9.84 35 136300 2789 29435403
Palindromic rheumatism 12.63 9.84 9 136326 186 29438006
Progressive multifocal leukoencephalopathy 12.52 9.84 13 136322 8706 29429486
Stevens-Johnson syndrome 12.40 9.84 37 136298 16460 29421732
Cardiogenic shock 12.39 9.84 46 136289 19144 29419048
Gangrene neonatal 12.39 9.84 9 136326 192 29438000
Red blood cell sedimentation rate 12.38 9.84 14 136321 540 29437652
Mouth ulceration 12.37 9.84 86 136249 10269 29427923
Haemolysis 12.30 9.84 64 136271 6892 29431300
Cholelithiasis 12.30 9.84 136 136199 18536 29419656
Excessive cerumen production 12.15 9.84 10 136325 258 29437934
Neonatal seizure 12.14 9.84 13 136322 471 29437721
Aggression 12.14 9.84 105 136230 35436 29402756
Pulmonary artery stenosis congenital 12.10 9.84 13 136322 473 29437719
Second primary malignancy 12.10 9.84 8 136327 6697 29431495
Malignant neoplasm progression 12.08 9.84 254 136081 73605 29364587
Wrong technique in product usage process 12.04 9.84 90 136245 31338 29406854
Neonatal infection 12.00 9.84 12 136323 401 29437791
Kidney infection 11.95 9.84 48 136287 4635 29433557
Psychomotor skills impaired 11.93 9.84 33 136302 2628 29435564
Meningeal disorder 11.92 9.84 11 136324 332 29437860
Irritability 11.89 9.84 57 136278 22095 29416097
Sexual dysfunction 11.82 9.84 6 136329 5808 29432384
Lung cancer metastatic 11.78 9.84 31 136304 2396 29435796
Cleft palate 11.78 9.84 14 136321 570 29437622
Non-Hodgkin's lymphoma 11.59 9.84 23 136312 1474 29436718
Anaemia vitamin B12 deficiency 11.52 9.84 10 136325 278 29437914
Decreased appetite 11.51 9.84 550 135785 144792 29293400
Back pain 11.46 9.84 579 135756 101705 29336487
Low set ears 11.43 9.84 12 136323 425 29437767
Neck pain 11.41 9.84 150 136185 21297 29416895
Hepatic enzyme increased 11.38 9.84 219 136116 33580 29404612
Steatorrhoea 11.38 9.84 15 136320 679 29437513
Appendix disorder 11.36 9.84 14 136321 592 29437600
Mean cell volume increased 11.29 9.84 31 136304 2458 29435734
Educational problem 11.24 9.84 13 136322 514 29437678
Vomiting 11.15 9.84 835 135500 211425 29226767
Agranulocytosis 11.12 9.84 52 136283 20288 29417904
Synovial cyst 11.08 9.84 26 136309 1871 29436321
Fine motor skill dysfunction 11.02 9.84 23 136312 1528 29436664
Foetal hypokinesia 11.01 9.84 11 136324 367 29437825
Squamous cell carcinoma 11.01 9.84 83 136252 10168 29428024
Nephrolithiasis 11.00 9.84 171 136164 25163 29413029
Pulmonary tuberculosis 10.83 9.84 44 136291 4271 29433921
Pharyngeal disorder 10.80 9.84 14 136321 623 29437569
Tachycardia 10.71 9.84 253 136082 72157 29366035
Sinusitis 10.71 9.84 220 136115 34130 29404062
Dermatitis psoriasiform 10.70 9.84 19 136316 1119 29437073
Tonsil cancer 10.69 9.84 17 136318 914 29437278
Lung neoplasm 10.69 9.84 44 136291 4296 29433896
Pancreatic duct stenosis 10.69 9.84 8 136327 179 29438013
Oesophageal atresia 10.65 9.84 12 136323 461 29437731
Myoclonus 10.63 9.84 29 136306 13280 29424912
Hypoxia 10.62 9.84 154 136181 47225 29390967
Granuloma skin 10.61 9.84 14 136321 634 29437558
Acute chest syndrome 10.59 9.84 10 136325 311 29437881
Peritoneal dialysis complication 10.56 9.84 23 136312 1574 29436618
Joint instability 10.51 9.84 11 136324 388 29437804
Neutropenia neonatal 10.46 9.84 14 136321 643 29437549
Moaning 10.46 9.84 15 136320 736 29437456
Obsessive-compulsive disorder 10.45 9.84 4 136331 4572 29433620
Nose deformity 10.42 9.84 8 136327 186 29438006
Maternal exposure before pregnancy 10.42 9.84 12 136323 472 29437720
Respiratory depression 10.40 9.84 30 136305 13493 29424699
Osteonecrosis of jaw 10.38 9.84 40 136295 16470 29421722
Skin lesion 10.34 9.84 131 136204 18441 29419751
Hypotension 10.30 9.84 764 135571 193590 29244602
Anti-erythropoietin antibody positive 10.29 9.84 16 136319 844 29437348
Transfusion-related circulatory overload 10.24 9.84 8 136327 191 29438001
Localised infection 10.21 9.84 103 136232 13713 29424479
Mesothelioma 10.20 9.84 11 136324 402 29437790
Retinopathy hypertensive 10.20 9.84 9 136326 256 29437936
Pharyngitis 10.19 9.84 61 136274 6922 29431270
Cytokine release syndrome 10.17 9.84 29 136306 13090 29425102
Chronic obstructive pulmonary disease 10.17 9.84 254 136081 40701 29397491
Toxic epidermal necrolysis 10.16 9.84 46 136289 18107 29420085
Skin graft failure 10.15 9.84 7 136328 137 29438055
Chronic graft versus host disease 10.11 9.84 3 136332 4026 29434166
Suspected suicide 10.07 9.84 3 136332 4017 29434175
Necrotising fasciitis streptococcal 10.07 9.84 7 136328 139 29438053
Congenital diaphragmatic hernia 10.05 9.84 9 136326 261 29437931
Placental insufficiency 9.97 9.84 6 136329 92 29438100
Adenovirus infection 9.97 9.84 4 136331 4443 29433749
Abnormal behaviour 9.96 9.84 64 136271 23063 29415129
Gross motor delay 9.94 9.84 9 136326 265 29437927
Shock haemorrhagic 9.93 9.84 18 136317 9533 29428659
Hypermetropia 9.92 9.84 11 136324 415 29437777
Mucosal ulceration 9.91 9.84 16 136319 872 29437320
Cystitis haemorrhagic 9.84 9.84 5 136330 4837 29433355

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Rheumatoid arthritis 1293.98 9.94 2957 381727 161337 63952711
Completed suicide 888.79 9.94 138 384546 224276 63889772
Pemphigus 832.65 9.94 1382 383302 59319 64054729
Arthropathy 824.04 9.94 2059 382625 118908 63995140
Joint swelling 798.29 9.94 2959 381725 212423 63901625
Systemic lupus erythematosus 797.34 9.94 1558 383126 76054 64037994
Hand deformity 762.26 9.94 1354 383330 61417 64052631
Synovitis 740.31 9.94 1748 382936 97342 64016706
Toxicity to various agents 732.05 9.94 655 384029 362858 63751190
Glossodynia 692.95 9.94 1322 383362 63374 64050674
Arthralgia 687.06 9.94 4749 379935 437511 63676537
Maternal exposure during pregnancy 639.11 9.94 1619 383065 94265 64019783
Drug abuse 616.31 9.94 45 384639 132329 63981719
Infusion related reaction 609.32 9.94 2260 382424 162207 63951841
Anti-cyclic citrullinated peptide antibody positive 573.46 9.94 1047 383637 48515 64065533
Wound 562.29 9.94 1341 383343 75136 64038912
Pericarditis 540.51 9.94 1169 383515 61347 64052701
Pain 497.49 9.94 5262 379422 548249 63565799
Abdominal discomfort 470.85 9.94 2244 382440 180078 63933970
Alopecia 429.72 9.94 2042 382642 163648 63950400
Swelling 409.99 9.94 1967 382717 158251 63955797
Therapeutic product effect decreased 405.30 9.94 1559 383125 113792 64000256
Contraindicated product administered 398.41 9.94 1481 383203 106348 64007700
Nasopharyngitis 394.05 9.94 2251 382433 193822 63920226
Drug interaction 385.25 9.94 1008 383676 361075 63752973
Discomfort 383.09 9.94 1207 383477 79671 64034377
Death 350.75 9.94 1584 383100 481121 63632927
Rheumatoid factor positive 342.45 9.94 688 383996 34250 64079798
Drug intolerance 339.00 9.94 2098 382586 185894 63928154
Duodenal ulcer perforation 332.43 9.94 676 384008 33949 64080099
Helicobacter infection 331.09 9.94 717 383967 37645 64076403
Exposure during pregnancy 329.89 9.94 1117 383567 76558 64037490
Musculoskeletal stiffness 310.99 9.94 1507 383177 121699 63992349
Intentional overdose 306.39 9.94 79 384605 89865 64024183
Hepatic enzyme increased 298.07 9.94 1547 383137 128396 63985652
Acute kidney injury 265.40 9.94 1582 383102 447658 63666390
Psoriatic arthropathy 251.73 9.94 695 383989 42586 64071462
C-reactive protein abnormal 241.67 9.94 535 384149 28512 64085536
Sinusitis 230.16 9.94 1575 383109 144353 63969695
Febrile neutropenia 227.50 9.94 487 384197 187170 63926878
Impaired healing 223.56 9.94 831 383853 59642 64054406
Overdose 215.08 9.94 389 384295 159177 63954871
Lower respiratory tract infection 200.91 9.94 1103 383581 93511 64020537
Cardiac arrest 196.73 9.94 388 384296 153676 63960372
Red blood cell sedimentation rate abnormal 195.55 9.94 350 384334 15956 64098092
Product use issue 194.54 9.94 1559 383125 150156 63963892
Hypersensitivity 192.32 9.94 1903 382781 194549 63919499
Peripheral swelling 191.34 9.94 1998 382686 207155 63906893
Treatment failure 190.25 9.94 1271 383413 115545 63998503
Muscle injury 182.86 9.94 453 384231 25984 64088064
Blood pressure fluctuation 181.97 9.94 701 383983 51170 64062878
Depressed level of consciousness 178.02 9.94 135 384549 81301 64032747
Arthritis 172.54 9.94 969 383715 82845 64031203
Sickle cell anaemia with crisis 170.83 9.94 184 384500 5148 64108900
Drug ineffective 168.26 9.94 6355 378329 833892 63280156
Suicide attempt 166.69 9.94 109 384575 70898 64043150
Folliculitis 166.07 9.94 474 384210 29603 64084445
Sleep disorder due to general medical condition, insomnia type 158.88 9.94 428 384256 25842 64088206
Hip arthroplasty 157.44 9.94 375 384309 20976 64093072
Bradycardia 156.77 9.94 291 384393 117928 63996120
Irritable bowel syndrome 156.48 9.94 535 384149 36834 64077214
Knee arthroplasty 156.43 9.94 433 384251 26566 64087482
Weight increased 147.00 9.94 1930 382754 211418 63902630
Drug reaction with eosinophilia and systemic symptoms 146.33 9.94 70 384614 54147 64059901
Psoriasis 146.26 9.94 827 383857 70876 64043172
Respiratory arrest 145.17 9.94 67 384617 52918 64061130
Osteoarthritis 142.31 9.94 750 383934 62586 64051462
Pregnancy 141.65 9.94 355 384329 20510 64093538
Rhabdomyolysis 138.08 9.94 208 384476 91518 64022530
Blister 137.88 9.94 891 383793 80076 64033972
Cardiac failure 132.59 9.94 379 384305 131994 63982054
Abortion spontaneous 131.84 9.94 389 384295 24754 64089294
Lactic acidosis 126.46 9.94 108 384576 61302 64052746
Renal failure 126.31 9.94 605 384079 181083 63932965
Injection site erythema 125.42 9.94 787 383897 70013 64044035
Infection 123.39 9.94 1663 383021 183217 63930831
Sedation 122.30 9.94 47 384637 41415 64072633
Hepatic function abnormal 120.77 9.94 123 384561 64190 64049858
Sopor 120.12 9.94 17 384667 29644 64084404
Malignant neoplasm progression 119.13 9.94 315 384369 112556 64001492
Disease progression 111.04 9.94 451 384233 141229 63972819
Serotonin syndrome 108.66 9.94 49 384635 39233 64074815
Ill-defined disorder 106.86 9.94 533 384151 43519 64070529
Red blood cell sedimentation rate increased 106.18 9.94 418 384266 30817 64083231
Contusion 105.65 9.94 1092 383592 112873 64001175
Enthesopathy 105.63 9.94 199 384485 9439 64104609
Blood pressure systolic increased 101.91 9.94 572 384112 48881 64065167
Neutropenia 101.20 9.94 927 383757 238697 63875351
Constipation 100.89 9.94 878 383806 228459 63885589
Injection site pruritus 99.91 9.94 469 384215 37357 64076691
Drug resistance 98.33 9.94 43 384641 35059 64078989
Hypotension 97.67 9.94 1641 383043 379333 63734715
Hypoglycaemia 97.05 9.94 248 384436 89644 64024404
Fatigue 96.03 9.94 5417 379267 743313 63370735
Multiple organ dysfunction syndrome 96.02 9.94 298 384386 101115 64012933
Respiratory failure 95.71 9.94 566 384118 160617 63953431
Injection site pain 95.56 9.94 1051 383633 110357 64003691
Joint effusion 95.43 9.94 233 384451 13240 64100808
Hyponatraemia 94.52 9.94 509 384175 147830 63966218
Agitation 94.47 9.94 245 384439 88122 64025926
Drug dependence 93.01 9.94 41 384643 33271 64080777
Cytomegalovirus infection 91.59 9.94 54 384630 37145 64076903
Juvenile idiopathic arthritis 90.96 9.94 114 384570 3765 64110283
Hepatic failure 90.95 9.94 118 384566 55276 64058772
Blood pressure diastolic abnormal 90.78 9.94 212 384472 11705 64102343
Live birth 89.41 9.94 203 384481 11001 64103047
Condition aggravated 89.30 9.94 2878 381806 369548 63744500
Pain in extremity 89.22 9.94 2403 382281 300682 63813366
Osteoporosis 88.22 9.94 489 384195 41591 64072457
Intentional product misuse 88.04 9.94 187 384497 72108 64041940
Blood pressure systolic abnormal 87.10 9.94 187 384497 9755 64104293
Product use in unapproved indication 85.96 9.94 658 384026 175960 63938088
Rheumatic fever 85.11 9.94 178 384506 9116 64104932
Rash 84.38 9.94 3439 381245 455110 63658938
Injection site reaction 84.06 9.94 521 384163 46143 64067905
Hyperglycaemia 83.55 9.94 147 384537 60821 64053227
Rheumatoid nodule 83.53 9.94 213 384471 12438 64101610
Renal impairment 82.35 9.94 470 384214 134547 63979501
Disability assessment scale score increased 82.27 9.94 88 384596 2442 64111606
Somnolence 80.77 9.94 800 383884 202845 63911203
Electrocardiogram QT prolonged 80.61 9.94 226 384458 79222 64034826
Coma 80.46 9.94 261 384423 87354 64026694
Grip strength decreased 80.13 9.94 200 384484 11524 64102524
Injection site swelling 79.76 9.94 470 384214 40883 64073165
Musculoskeletal pain 79.18 9.94 787 383897 80507 64033541
Cardio-respiratory arrest 79.10 9.94 310 384374 98083 64015965
Tenosynovitis 78.93 9.94 200 384484 11633 64102415
Swollen joint count increased 78.43 9.94 154 384530 7535 64106513
Fibromyalgia 78.12 9.94 420 384264 35311 64078737
Caesarean section 77.76 9.94 193 384491 11081 64102967
Intentional self-injury 77.60 9.94 38 384646 29006 64085042
Blood pressure diastolic decreased 77.06 9.94 300 384384 22001 64092047
Palmar-plantar erythrodysaesthesia syndrome 75.06 9.94 39 384645 28780 64085268
Foot deformity 75.06 9.94 243 384441 16261 64097787
Poisoning 73.00 9.94 20 384664 21859 64092189
Device expulsion 71.12 9.94 19 384665 21117 64092931
Hypoxia 70.05 9.94 279 384405 87870 64026178
Tachycardia 69.64 9.94 564 384120 149015 63965033
Joint laxity 69.17 9.94 77 384607 2237 64111811
Blood pressure increased 69.09 9.94 1428 383256 171124 63942924
Heart rate decreased 68.93 9.94 563 384121 54504 64059544
Delirium 68.60 9.94 199 384485 68995 64045053
Joint stiffness 67.56 9.94 359 384325 30045 64084003
Neoplasm progression 67.52 9.94 87 384597 40877 64073171
Altered state of consciousness 67.24 9.94 76 384608 37826 64076222
Gastrointestinal disorder 66.54 9.94 823 383861 88886 64025162
Disseminated intravascular coagulation 66.46 9.94 57 384627 32291 64081757
Drug withdrawal syndrome 65.68 9.94 54 384630 31237 64082811
C-reactive protein increased 65.44 9.94 859 383825 94050 64019998
Shock 65.34 9.94 79 384605 38161 64075887
Localised infection 64.90 9.94 353 384331 29808 64084240
Injection site bruising 64.82 9.94 405 384279 35968 64078080
Encephalopathy 64.46 9.94 161 384523 58658 64055390
Respiratory depression 63.66 9.94 30 384654 23413 64090635
Inflammation 62.54 9.94 630 384054 64670 64049378
Basal cell carcinoma 62.41 9.94 355 384329 30483 64083565
Loss of personal independence in daily activities 61.87 9.94 683 384001 71771 64042277
Bone erosion 61.36 9.94 180 384504 11415 64102633
Femur fracture 60.78 9.94 380 384304 33755 64080293
Gestational diabetes 59.51 9.94 114 384570 5476 64108572
Polyarthritis 59.46 9.94 159 384525 9556 64104492
Metabolic acidosis 58.68 9.94 221 384463 70737 64043311
Thrombocytopenia 58.56 9.94 960 383724 222841 63891207
Syncope 58.48 9.94 629 384055 157006 63957042
Tongue disorder 57.80 9.94 181 384503 11899 64102149
Cardiac failure congestive 57.78 9.94 499 384185 130081 63983967
Cholestasis 57.23 9.94 113 384571 44759 64069289
Blood creatine phosphokinase increased 56.90 9.94 170 384514 58388 64055660
Oropharyngeal pain 56.21 9.94 792 383892 88075 64025973
Immune reconstitution inflammatory syndrome 55.88 9.94 5 384679 12465 64101583
Diabetic ketoacidosis 54.98 9.94 58 384626 29787 64084261
Mydriasis 54.98 9.94 12 384672 15300 64098748
Cerebral haemorrhage 54.32 9.94 142 384542 50948 64063100
Neuropathy peripheral 54.30 9.94 444 384240 117081 63996967
Cognitive disorder 54.19 9.94 159 384525 54928 64059120
Blood pressure diastolic increased 54.14 9.94 164 384520 10588 64103460
Angioedema 53.45 9.94 189 384495 61632 64052416
Tendonitis 53.20 9.94 251 384433 20031 64094017
Tremor 52.79 9.94 597 384087 147633 63966415
Hyperhidrosis 52.36 9.94 484 384200 124436 63989612
Stomatitis 52.01 9.94 931 383753 108674 64005374
Premature delivery 51.68 9.94 234 384450 18355 64095693
Nodule 51.46 9.94 228 384456 17719 64096329
Injection site rash 51.36 9.94 208 384476 15534 64098514
Acute hepatic failure 51.26 9.94 48 384636 26064 64087984
Disturbance in attention 51.04 9.94 105 384579 40969 64073079
Anaemia 51.02 9.94 1797 382887 376883 63737165
Pulmonary fibrosis 50.35 9.94 328 384356 29550 64084498
Body temperature decreased 50.20 9.94 295 384389 25633 64088415
Neuroleptic malignant syndrome 50.19 9.94 45 384639 24951 64089097
Hypothermia 50.06 9.94 28 384656 19828 64094220
Hallucination 49.01 9.94 245 384439 72543 64041505
Hyperkalaemia 48.59 9.94 378 384306 100751 64013297
Vomiting 47.93 9.94 2744 381940 548373 63565675
Herpes zoster 47.80 9.94 700 383984 78487 64035561
Pre-eclampsia 47.63 9.94 111 384573 6120 64107928
Hepatocellular injury 47.13 9.94 127 384557 45108 64068940
Synovial cyst 47.03 9.94 126 384558 7581 64106467
Fracture 46.95 9.94 229 384455 18526 64095522
Sedation complication 46.81 9.94 4 384680 10350 64103698
Joint destruction 46.12 9.94 80 384604 3556 64110492
Tenderness 46 9.94 235 384449 19367 64094681
Maternal exposure before pregnancy 44.66 9.94 77 384607 3406 64110642
Neck deformity 44.50 9.94 53 384631 1659 64112389
Disability 43.90 9.94 166 384518 12006 64102042
Hypokalaemia 43.38 9.94 491 384193 121412 63992636
Asthenia 43.26 9.94 2099 382585 425945 63688103
Ventricular tachycardia 43.08 9.94 87 384597 34178 64079870
Myalgia 42.93 9.94 676 384008 157941 63956107
Infective pulmonary exacerbation of cystic fibrosis 42.85 9.94 9 384675 11787 64102261
Brain oedema 42.84 9.94 41 384643 22034 64092014
Speech disorder 42.61 9.94 147 384537 48294 64065754
Abnormal behaviour 42.59 9.94 85 384599 33537 64080511
Red blood cell sedimentation rate 42.34 9.94 78 384606 3636 64110412
Neurotoxicity 42.34 9.94 61 384623 27343 64086705
Mental status changes 42.26 9.94 204 384480 60958 64053090
Joint range of motion decreased 42.03 9.94 227 384457 19116 64094932
Restlessness 41.98 9.94 111 384573 39674 64074374
Joint injury 41.82 9.94 257 384427 22690 64091358
Myoclonus 41.75 9.94 53 384631 25065 64088983
Alanine aminotransferase abnormal 41.42 9.94 112 384572 6776 64107272
Neck mass 41.25 9.94 81 384603 3963 64110085
Laryngitis 41.09 9.94 152 384532 10879 64103169
Premature labour 41 9.94 119 384565 7501 64106547
Dyspnoea 40.90 9.94 3711 380973 714963 63399085
Irritability 40.72 9.94 100 384584 36646 64077402
Respiratory distress 40.70 9.94 167 384517 52164 64061884
Seizure 40.68 9.94 725 383959 166167 63947881
Premature rupture of membranes 40.65 9.94 77 384607 3667 64110381
Skin ulcer 40.54 9.94 421 384263 43553 64070495
Anxiety 40.49 9.94 910 383774 201739 63912309
Limb deformity 40.11 9.94 72 384612 3289 64110759
Cytokine release syndrome 40.05 9.94 39 384645 20790 64093258
Ventricular fibrillation 40.02 9.94 50 384634 23810 64090238
Leukopenia 39.98 9.94 398 384286 100844 64013204
Venoocclusive liver disease 39.95 9.94 6 384678 10009 64104039
Disorientation 39.87 9.94 184 384500 55644 64058404
Neutrophil count decreased 39.72 9.94 283 384401 76913 64037135
Unresponsive to stimuli 39.71 9.94 160 384524 50233 64063815
Orthostatic hypotension 39.66 9.94 144 384540 46594 64067454
Myocardial infarction 39.59 9.94 723 383961 165098 63948950
Smear cervix abnormal 39.37 9.94 59 384625 2315 64111733
Dehydration 39.27 9.94 988 383696 215775 63898273
Tuberculosis 39.19 9.94 168 384516 12870 64101178
Dizziness 39.14 9.94 2132 382552 428031 63686017
Diarrhoea 39.09 9.94 3746 380938 718958 63395090
Anaphylactic shock 39.00 9.94 76 384608 30252 64083796
Poor venous access 38.87 9.94 162 384522 12255 64101793
Ejection fraction decreased 38.62 9.94 70 384614 28637 64085411
Posterior reversible encephalopathy syndrome 38.58 9.94 48 384636 22898 64091150
Decreased appetite 38.50 9.94 1332 383352 279957 63834091
Bronchitis 38.41 9.94 884 383800 107859 64006189
Substance abuse 38.40 9.94 5 384679 9287 64104761
Cardiogenic shock 37.72 9.94 86 384598 32341 64081707
Pulmonary arterial hypertension 37.70 9.94 58 384626 25309 64088739
Urticaria 37.50 9.94 635 384049 146682 63967366
Bone disorder 37.31 9.94 198 384486 16561 64097487
Oral herpes 37.21 9.94 243 384441 21909 64092139
Extrapyramidal disorder 37.15 9.94 37 384647 19515 64094533
Arthritis infective 37.07 9.94 109 384575 6921 64107127
Psychotic disorder 36.84 9.94 96 384588 34482 64079566
Melaena 36.76 9.94 179 384505 53369 64060679
Status epilepticus 36.75 9.94 45 384639 21618 64092430
Latent tuberculosis 36.73 9.94 62 384622 2695 64111353
Blood glucose increased 36.49 9.94 391 384293 97682 64016366
Drug level increased 36.39 9.94 95 384589 34101 64079947
Spinal stenosis 36.25 9.94 172 384512 13759 64100289
Therapeutic response decreased 36.23 9.94 473 384211 51715 64062333
Influenza 36.08 9.94 861 383823 105670 64008378
Multiple sclerosis relapse 36.07 9.94 125 384559 41010 64073038
Fluid retention 36.04 9.94 208 384476 59398 64054650
Accidental overdose 35.88 9.94 93 384591 33464 64080584
Pathogen resistance 35.71 9.94 15 384669 12528 64101520
Aggression 35.67 9.94 148 384536 46084 64067964
Pulmonary embolism 35.28 9.94 637 384047 145719 63968329
Suicidal ideation 35.19 9.94 242 384442 66300 64047748
Torsade de pointes 35.17 9.94 31 384653 17332 64096716
Multiple fractures 35.11 9.94 97 384587 5943 64108105
Product quality issue 34.69 9.94 79 384605 29720 64084328
Cerebral infarction 34.47 9.94 127 384557 40917 64073131
Blood cholesterol increased 34.43 9.94 453 384231 49613 64064435
Fear of injection 34.42 9.94 95 384589 5817 64108231
Skin cancer 34.24 9.94 152 384532 11822 64102226
Psychomotor hyperactivity 34.15 9.94 22 384662 14429 64099619
Inappropriate antidiuretic hormone secretion 34.05 9.94 50 384634 22239 64091809
Pancytopenia 33.85 9.94 1106 383578 142203 63971845
Agranulocytosis 33.63 9.94 116 384568 38113 64075935
Immunodeficiency 33.54 9.94 187 384497 15937 64098111
Ascites 33.53 9.94 224 384460 61777 64052271
Arrhythmia 33.51 9.94 182 384502 52762 64061286
Proteinuria 33.50 9.94 72 384612 27651 64086397
Asphyxia 33.34 9.94 8 384676 9558 64104490
Wheelchair user 33.30 9.94 81 384603 4591 64109457
Gastrointestinal haemorrhage 33.13 9.94 572 384112 131740 63982308
Ear infection 33.00 9.94 246 384438 23158 64090890
Rash maculo-papular 32.98 9.94 156 384528 46870 64067178
Surgery 32.94 9.94 284 384400 27929 64086119
Tenosynovitis stenosans 32.91 9.94 49 384635 1911 64112137
Bradyphrenia 32.52 9.94 8 384676 9398 64104650
Mouth ulceration 32.51 9.94 316 384368 32128 64081920
Foot fracture 32.24 9.94 202 384482 17955 64096093
Skin papilloma 31.69 9.94 85 384599 5118 64108930
Second primary malignancy 31.68 9.94 17 384667 12320 64101728
Blood creatinine increased 31.47 9.94 595 384089 135187 63978861
No adverse event 31.43 9.94 78 384606 28483 64085565
Nausea 31.38 9.94 4158 380526 781642 63332406
Haematotoxicity 31.35 9.94 19 384665 12877 64101171
Gastroenteritis viral 31.08 9.94 213 384471 19516 64094532
Mobility decreased 30.99 9.94 700 383984 85140 64028908
Bronchopulmonary aspergillosis 30.97 9.94 41 384643 19044 64095004
Withdrawal syndrome 30.96 9.94 58 384626 23434 64090614
Atrial fibrillation 30.93 9.94 780 383904 170309 63943739
Akathisia 30.84 9.94 15 384669 11495 64102553
Malignant melanoma 30.83 9.94 156 384528 12808 64101240
Product administration error 30.81 9.94 75 384609 27568 64086480
Injection site warmth 30.62 9.94 160 384524 13302 64100746
Tachypnoea 30.48 9.94 71 384613 26500 64087548
Rotator cuff repair 30.39 9.94 41 384643 1458 64112590
Miosis 30.27 9.94 21 384663 13245 64100803
Joint noise 29.99 9.94 62 384622 3149 64110899
Aspergillus infection 29.98 9.94 32 384652 16347 64097701
Intentional product use issue 29.97 9.94 763 383921 94601 64019447
Transplant rejection 29.67 9.94 36 384648 17365 64096683
Shock haemorrhagic 29.42 9.94 34 384650 16757 64097291
Unintentional medical device removal 29.38 9.94 3 384681 6731 64107317
Vision blurred 29.36 9.94 371 384313 89945 64024103
Coagulopathy 29.35 9.94 95 384589 31825 64082223
Ischaemic stroke 29.14 9.94 83 384601 28952 64085096
Subdural haematoma 29.04 9.94 79 384605 27975 64086073
Acute graft versus host disease 29.03 9.94 9 384675 9075 64104973
Synovial fluid analysis 28.93 9.94 41 384643 1528 64112520
Asthma 28.82 9.94 397 384287 94828 64019220
Balance disorder 28.70 9.94 341 384343 83585 64030463
Eosinophilia 28.69 9.94 123 384561 37953 64076095
Gamma-glutamyltransferase increased 28.42 9.94 171 384513 48339 64065709
Acute respiratory failure 28.22 9.94 178 384506 49756 64064292
Emotional distress 28.03 9.94 115 384569 35923 64078125
Blood parathyroid hormone decreased 27.85 9.94 102 384582 7264 64106784
Ulcer 27.67 9.94 233 384451 22757 64091291
Forced expiratory volume decreased 27.65 9.94 4 384680 6863 64107185
Foetal death 27.59 9.94 88 384596 5842 64108206
Tumour lysis syndrome 27.43 9.94 46 384638 19394 64094654
Maternal exposure timing unspecified 27.35 9.94 54 384630 2653 64111395
Loose body in joint 27.30 9.94 35 384649 1183 64112865
Dystonia 27.21 9.94 44 384640 18821 64095227
Loss of consciousness 27.19 9.94 675 384009 147690 63966358
Hypertransaminasaemia 27.15 9.94 5 384679 7186 64106862
Coronary artery disease 27.13 9.94 230 384454 60203 64053845
Thrombotic microangiopathy 26.80 9.94 36 384648 16619 64097429
Pulmonary oedema 26.77 9.94 320 384364 78354 64035694
Anaphylactic reaction 26.66 9.94 271 384413 68393 64045655
Haemoptysis 26.62 9.94 177 384507 48871 64065177
Acute chest syndrome 26.56 9.94 30 384654 886 64113162
Rhinorrhoea 26.55 9.94 504 384180 59465 64054583
Graft versus host disease 26.40 9.94 26 384658 13787 64100261
Erythema multiforme 26.23 9.94 33 384651 15668 64098380
BK virus infection 26.23 9.94 6 384678 7406 64106642
Blood alkaline phosphatase increased 25.81 9.94 213 384471 56066 64057982
Respiratory disorder 25.79 9.94 119 384565 35992 64078056
Sepsis 25.74 9.94 1117 383567 229224 63884824
Osteonecrosis of jaw 25.70 9.94 136 384548 39689 64074359
Fracture delayed union 25.60 9.94 44 384640 1941 64112107
Fear 25.54 9.94 51 384633 20120 64093928
Creatinine renal clearance decreased 25.49 9.94 29 384655 14392 64099656
Mania 25.41 9.94 36 384648 16250 64097798
Cyst 25.36 9.94 140 384544 11887 64102161
Post procedural infection 25.34 9.94 119 384565 9478 64104570
Drug ineffective for unapproved indication 25.06 9.94 98 384586 31035 64083013
Postoperative wound infection 25.01 9.94 125 384559 10211 64103837
Dysarthria 24.95 9.94 230 384454 59176 64054872
Antinuclear antibody positive 24.87 9.94 88 384596 6162 64107886
Polyhydramnios 24.72 9.94 37 384647 1450 64112598
Exostosis 24.69 9.94 134 384550 11304 64102744
Blood bilirubin increased 24.53 9.94 222 384462 57331 64056717
Muscle spasms 24.40 9.94 647 384037 140376 63973672
White blood cell count decreased 24.29 9.94 736 383948 157101 63956947
Oxygen saturation decreased 24.24 9.94 823 383861 106353 64007695
Granuloma skin 23.72 9.94 85 384599 5989 64108059
Clostridium difficile colitis 23.68 9.94 83 384601 27140 64086908
Hyperthermia 23.64 9.94 35 384649 15515 64098533
Pyrexia 23.58 9.94 2945 381739 555699 63558349
Chronic kidney disease 23.57 9.94 226 384458 57693 64056355
Acute respiratory distress syndrome 23.47 9.94 136 384548 38799 64075249
Dysgeusia 23.46 9.94 174 384510 46873 64067175
Pleural effusion 23.40 9.94 575 384109 125984 63988064
Panniculitis 23.37 9.94 110 384574 8769 64105279
Cerebrovascular accident 23.34 9.94 633 384051 136950 63977098
Drug use disorder 23.31 9.94 4 384680 6050 64107998
Bursitis 22.88 9.94 212 384472 21273 64092775
Scleritis 22.85 9.94 53 384631 2913 64111135
Haemorrhage intracranial 22.72 9.94 70 384614 23814 64090234
Dry eye 22.71 9.94 269 384415 28750 64085298
Stevens-Johnson syndrome 22.64 9.94 116 384568 34133 64079915
Adverse event 22.62 9.94 346 384338 39143 64074905
Face oedema 22.55 9.94 74 384610 24687 64089361
Joint dislocation 22.55 9.94 131 384553 11334 64102714
Pharyngitis streptococcal 22.54 9.94 107 384577 8561 64105487
Deep vein thrombosis 22.53 9.94 467 384217 104715 64009333
Platelet count decreased 22.50 9.94 796 383888 166915 63947133
Leukocytosis 22.12 9.94 133 384551 37607 64076441
Acute generalised exanthematous pustulosis 22.00 9.94 31 384653 14027 64100021
Haemorrhage 21.85 9.94 337 384347 79014 64035034
Cardiac failure acute 21.85 9.94 40 384644 16304 64097744
Wrong technique in product usage process 21.83 9.94 265 384419 64709 64049339
Stillbirth 21.77 9.94 59 384625 3574 64110474
Toxic skin eruption 21.74 9.94 52 384632 19232 64094816
Jaundice 21.61 9.94 185 384499 48327 64065721
Glycosylated haemoglobin increased 21.60 9.94 39 384645 15980 64098068
Acute graft versus host disease in skin 21.53 9.94 7 384677 6848 64107200
Drug hypersensitivity 21.52 9.94 1179 383505 236636 63877412
Pulmonary alveolar haemorrhage 21.45 9.94 16 384668 9722 64104326
Potentiating drug interaction 21.39 9.94 10 384674 7842 64106206
Cushingoid 21.35 9.94 96 384588 7507 64106541
Dactylitis 21.22 9.94 40 384644 1898 64112150
Pneumatosis intestinalis 21.16 9.94 3 384681 5226 64108822
Cyanosis 21.03 9.94 65 384619 22090 64091958
Aphasia 21.02 9.94 150 384534 40756 64073292
Bronchospasm 21.02 9.94 63 384621 21619 64092429
Haemoglobin decreased 21.01 9.94 1391 383293 193672 63920376
Hallucination, visual 20.92 9.94 90 384594 27744 64086304
Hyperammonaemia 20.90 9.94 17 384667 9887 64104161
Synovial disorder 20.87 9.94 27 384657 921 64113127
Vertigo 20.86 9.94 238 384446 58773 64055275
Pulmonary tuberculosis 20.75 9.94 92 384592 7152 64106896
Hypomagnesaemia 20.73 9.94 134 384550 37242 64076806
Endodontic procedure 20.70 9.94 44 384640 2279 64111769
Stress cardiomyopathy 20.67 9.94 15 384669 9242 64104806
Respiration abnormal 20.64 9.94 6 384678 6309 64107739
Febrile bone marrow aplasia 20.59 9.94 22 384662 11233 64102815
Acute myeloid leukaemia 20.51 9.94 89 384595 27374 64086674
Breast feeding 20.50 9.94 23 384661 674 64113374
Pancreatitis 20.45 9.94 242 384442 59365 64054683
Hyperbilirubinaemia 20.28 9.94 62 384622 21143 64092905
Weight decreased 20.26 9.94 1973 382711 283766 63830282
Adenovirus infection 20.14 9.94 9 384675 7246 64106802
Dyspnoea exertional 20.01 9.94 314 384370 73416 64040632
Dyskinesia 19.97 9.94 145 384539 39243 64074805
Exposure to toxic agent 19.86 9.94 6 384678 6153 64107895
Hepatic encephalopathy 19.86 9.94 62 384622 21004 64093044
Normal newborn 19.76 9.94 76 384608 5541 64108507
Hyperuricaemia 19.69 9.94 19 384665 10172 64103876
Endophthalmitis 19.68 9.94 4 384680 5361 64108687
Lupus-like syndrome 19.66 9.94 104 384580 8687 64105361
Device use error 19.65 9.94 7 384677 6464 64107584
Nightmare 19.64 9.94 62 384622 20931 64093117
Incorrect route of product administration 19.62 9.94 72 384612 23226 64090822
Depression 19.62 9.94 893 383791 182398 63931650
Aspartate aminotransferase increased 19.57 9.94 554 384130 119234 63994814
Rebound effect 19.49 9.94 3 384681 4914 64109134
Spinal disorder 19.38 9.94 103 384581 8619 64105429
Metastases to bone 19.36 9.94 60 384624 20375 64093673
Acidosis 19.27 9.94 49 384635 17746 64096302
Delusion 19.20 9.94 50 384634 17964 64096084
Human antichimeric antibody positive 19.07 9.94 32 384652 1384 64112664
Cytomegalovirus viraemia 18.89 9.94 22 384662 10806 64103242
Foetal distress syndrome 18.87 9.94 18 384666 434 64113614
Colitis ulcerative 18.70 9.94 215 384469 22813 64091235
Polyuria 18.70 9.94 29 384655 12614 64101434
Haemorrhage in pregnancy 18.69 9.94 30 384654 1250 64112798
Nocardiosis 18.69 9.94 3 384681 4764 64109284
Haemophagocytic lymphohistiocytosis 18.67 9.94 49 384635 17560 64096488
Tooth infection 18.65 9.94 150 384534 14451 64099597
Lipase increased 18.59 9.94 36 384648 14366 64099682
Sinus tachycardia 18.57 9.94 114 384570 32074 64081974
Mass 18.48 9.94 155 384529 15121 64098927
Induced labour 18.48 9.94 24 384660 822 64113226
Polyneuropathy 18.44 9.94 59 384625 19835 64094213
Bone pain 18.36 9.94 188 384496 47384 64066664
Toxic epidermal necrolysis 18.27 9.94 138 384546 37028 64077020
Muscle rigidity 18.24 9.94 49 384635 17424 64096624
Musculoskeletal disorder 18.23 9.94 175 384509 17731 64096317
Ingrown hair 18.22 9.94 20 384664 572 64113476
Tooth abscess 18.19 9.94 143 384541 13683 64100365
Polydipsia 18.19 9.94 6 384678 5815 64108233
Tubulointerstitial nephritis 18.08 9.94 109 384575 30800 64083248
Hallucination, auditory 18.07 9.94 47 384637 16892 64097156
Labelled drug-drug interaction medication error 18.05 9.94 69 384615 21993 64092055
Cytopenia 18.02 9.94 41 384643 15430 64098618
Heart rate irregular 18.01 9.94 246 384438 27167 64086881
Muscle spasticity 17.97 9.94 46 384638 16623 64097425
Placental disorder 17.95 9.94 24 384660 846 64113202
Anhedonia 17.92 9.94 34 384650 13672 64100376
Pain in jaw 17.90 9.94 156 384528 40599 64073449
Off label use 17.83 9.94 3415 381269 629391 63484657
Injection site urticaria 17.78 9.94 121 384563 11060 64102988
Upper respiratory tract infection 17.76 9.94 564 384120 72221 64041827
Anuria 17.74 9.94 56 384628 18908 64095140
Frequent bowel movements 17.71 9.94 177 384507 18128 64095920
Tooth disorder 17.68 9.94 208 384476 22194 64091854
Cystitis haemorrhagic 17.62 9.94 13 384671 7943 64106105
Lacrimal disorder 17.62 9.94 18 384666 473 64113575
Pleuritic pain 17.58 9.94 95 384589 8001 64106047
Pancreatitis acute 17.53 9.94 167 384517 42688 64071360
Oliguria 17.49 9.94 38 384646 14538 64099510
Chest discomfort 17.47 9.94 543 384141 115563 63998485
Angina pectoris 17.47 9.94 178 384506 44903 64069145
Haematocrit decreased 17.38 9.94 438 384246 54217 64059831
Pulmonary hypertension 17.27 9.94 169 384515 42970 64071078
Cellulitis 17.27 9.94 703 383981 92954 64021094
Flushing 17.20 9.94 348 384336 78300 64035748
Chronic graft versus host disease 17.09 9.94 8 384676 6268 64107780
Arthritis bacterial 17.03 9.94 92 384592 7747 64106301
Dislocation of vertebra 17.01 9.94 49 384635 3075 64110973
Affective disorder 16.99 9.94 9 384675 6571 64107477
Joint lock 16.99 9.94 46 384638 2785 64111263
Hyperlactacidaemia 16.98 9.94 4 384680 4840 64109208
Toothache 16.98 9.94 169 384515 17290 64096758
Progressive multifocal leukoencephalopathy 16.95 9.94 54 384630 18178 64095870
Blood pressure decreased 16.94 9.94 388 384296 85811 64028237
Immunosuppression 16.92 9.94 116 384568 10630 64103418
Bone density abnormal 16.87 9.94 45 384639 2700 64111348
Body height below normal 16.86 9.94 35 384649 1783 64112265
Urinary retention 16.78 9.94 200 384484 49001 64065047
Tardive dyskinesia 16.72 9.94 18 384666 9160 64104888
Maternal exposure during breast feeding 16.61 9.94 37 384647 1979 64112069
Metastases to lung 16.55 9.94 42 384642 15222 64098826
Sexual dysfunction 16.49 9.94 9 384675 6462 64107586
Klebsiella infection 16.46 9.94 34 384650 13247 64100801
Metastases to liver 16.45 9.94 80 384604 23861 64090187
Placental insufficiency 16.42 9.94 25 384659 995 64113053
Hemiplegia 16.41 9.94 32 384652 12736 64101312
Osteopenia 16.38 9.94 153 384531 15387 64098661
Gestational hypertension 16.34 9.94 33 384651 1648 64112400
Pulseless electrical activity 16.31 9.94 32 384652 12707 64101341
Epstein-Barr virus infection 16.31 9.94 31 384653 12457 64101591
Blood lactic acid increased 16.22 9.94 23 384661 10378 64103670
Atrioventricular block complete 16.16 9.94 39 384645 14379 64099669
Type 2 diabetes mellitus 16.13 9.94 289 384395 33731 64080317
Wound infection 16.00 9.94 147 384537 14717 64099331
Wound infection pseudomonas 15.99 9.94 31 384653 1502 64112546
Device difficult to use 15.95 9.94 21 384663 9777 64104271
Electrocardiogram QRS complex prolonged 15.89 9.94 19 384665 9225 64104823
Pulmonary haemorrhage 15.88 9.94 34 384650 13075 64100973
Lymphatic fistula 15.77 9.94 21 384663 737 64113311
Drug-induced liver injury 15.74 9.94 195 384489 47448 64066600
Femoral hernia incarcerated 15.71 9.94 21 384663 740 64113308
Insomnia 15.70 9.94 993 383691 196843 63917205
Tuberculin test positive 15.64 9.94 47 384637 3021 64111027
Hepatitis fulminant 15.60 9.94 9 384675 6265 64107783
Injection site haemorrhage 15.59 9.94 217 384467 24061 64089987
Hypophosphataemia 15.58 9.94 41 384643 14679 64099369
Nephropathy toxic 15.50 9.94 53 384631 17461 64096587
Gastric haemorrhage 15.48 9.94 36 384648 13445 64100603
Acute coronary syndrome 15.41 9.94 61 384623 19249 64094799
Cystitis 15.39 9.94 348 384336 42327 64071721
Arthropod bite 15.37 9.94 80 384604 6641 64107407
Chest pain 15.37 9.94 1205 383479 234775 63879273
Hypoalbuminaemia 15.30 9.94 54 384630 17620 64096428
Cervical incompetence 15.24 9.94 17 384667 495 64113553
Septic shock 15.16 9.94 496 384188 104941 64009107
Alcohol abuse 15.16 9.94 5 384679 4847 64109201
Kidney infection 15.15 9.94 168 384516 17670 64096378
Acute myocardial infarction 15.09 9.94 309 384375 69409 64044639
Peripheral sensory neuropathy 15.08 9.94 28 384656 11350 64102698
Obstructive airways disorder 15.06 9.94 79 384605 23106 64090942
Sciatica 15.05 9.94 186 384498 20078 64093970
Dysphagia 15 9.94 504 384180 106308 64007740
Catatonia 14.96 9.94 14 384670 7606 64106442
Hypervolaemia 14.90 9.94 151 384533 38134 64075914
Dermatitis acneiform 14.90 9.94 17 384667 8426 64105622
Sinus bradycardia 14.87 9.94 78 384606 22815 64091233
Renal injury 14.83 9.94 45 384639 15384 64098664
Adjustment disorder with depressed mood 14.82 9.94 40 384644 2417 64111631
International normalised ratio increased 14.81 9.94 359 384325 78808 64035240
Iodine allergy 14.81 9.94 17 384667 511 64113537
Interstitial lung disease 14.72 9.94 457 384227 97275 64016773
Clear cell renal cell carcinoma 14.71 9.94 37 384647 2142 64111906
Visual acuity reduced 14.70 9.94 98 384586 27043 64087005
Atrioventricular block 14.69 9.94 31 384653 11984 64102064
Pharyngitis 14.68 9.94 176 384508 18863 64095185
Malignant mediastinal neoplasm 14.66 9.94 17 384667 517 64113531
Sickle cell anaemia 14.61 9.94 18 384666 584 64113464
Rheumatoid lung 14.60 9.94 40 384644 2439 64111609
Aphthous ulcer 14.59 9.94 129 384555 12777 64101271
Abortion threatened 14.56 9.94 15 384669 398 64113650
Injection site discolouration 14.48 9.94 80 384604 6795 64107253
Lymphocyte count decreased 14.44 9.94 164 384520 40535 64073513
Hepatitis acute 14.39 9.94 37 384647 13352 64100696
Coronary arterial stent insertion 14.39 9.94 8 384676 5684 64108364
Injection site extravasation 14.38 9.94 90 384594 7996 64106052
Antibody test positive 14.33 9.94 39 384645 2368 64111680
Ankle arthroplasty 14.29 9.94 22 384662 884 64113164
Red blood cell count decreased 14.29 9.94 384 384300 48002 64066046
Finger deformity 14.20 9.94 65 384619 5121 64108927
Respiratory acidosis 14.20 9.94 23 384661 9832 64104216
Peritoneal dialysis complication 14.18 9.94 37 384647 2191 64111857
Disease recurrence 14.11 9.94 120 384564 31390 64082658
Paralysis 14.10 9.94 30 384654 11565 64102483
Cardiac failure chronic 14.09 9.94 20 384664 9021 64105027
Pulmonary congestion 14.08 9.94 84 384600 23796 64090252
Pneumothorax 14.05 9.94 86 384598 24212 64089836
Right ventricular failure 14.03 9.94 73 384611 21398 64092650
Cardiomyopathy 14.01 9.94 91 384593 25265 64088783
Joint warmth 14.01 9.94 28 384656 1388 64112660
Ileus 13.96 9.94 80 384604 22886 64091162
Cholestasis of pregnancy 13.95 9.94 22 384662 903 64113145
Eye infection 13.91 9.94 99 384585 9182 64104866
Knee operation 13.91 9.94 59 384625 4498 64109550
Enterocolitis 13.87 9.94 32 384652 11986 64102062
Pancreatic steatosis 13.87 9.94 23 384661 985 64113063
Foot operation 13.85 9.94 56 384628 4179 64109869
Transaminases increased 13.82 9.94 185 384499 44409 64069639
Small for dates baby 13.80 9.94 15 384669 424 64113624
Metastases to central nervous system 13.79 9.94 40 384644 13872 64100176
Cytomegalovirus chorioretinitis 13.78 9.94 6 384678 4906 64109142
Temperature regulation disorder 13.77 9.94 4 384680 4207 64109841
Ileus paralytic 13.73 9.94 18 384666 8397 64105651
Blood loss anaemia 13.73 9.94 40 384644 13852 64100196
End stage renal disease 13.68 9.94 26 384658 10449 64103599
Serum ferritin increased 13.68 9.94 92 384592 8376 64105672
Bacteraemia 13.67 9.94 99 384585 26812 64087236
Nephrolithiasis 13.57 9.94 349 384335 43334 64070714
Drug specific antibody 13.55 9.94 35 384649 2060 64111988
Tendon disorder 13.55 9.94 74 384610 6258 64107790
Hepatitis cholestatic 13.53 9.94 33 384651 12122 64101926
Hyperthyroidism 13.53 9.94 59 384625 18120 64095928
Human anti-human antibody test 13.52 9.94 14 384670 374 64113674
Drug abuser 13.51 9.94 9 384675 5799 64108249
Palindromic rheumatism 13.51 9.94 13 384671 317 64113731
Myocarditis 13.49 9.94 54 384630 16989 64097059
Breast abscess 13.48 9.94 24 384660 1089 64112959
Blood calcium decreased 13.48 9.94 93 384591 25461 64088587
Sinus congestion 13.38 9.94 146 384538 15293 64098755
Product prescribing error 13.36 9.94 140 384544 35129 64078919
Muscle twitching 13.33 9.94 63 384621 18935 64095113
C-reactive protein decreased 13.32 9.94 35 384649 2081 64111967
Palpitations 13.31 9.94 499 384185 103989 64010059
Lung transplant 13.25 9.94 4 384680 4104 64109944
Haematoma 13.22 9.94 195 384489 46055 64067993
Hemiparesis 13.17 9.94 114 384570 29713 64084335
Drug screen positive 13.16 9.94 9 384675 5720 64108328
Toxic encephalopathy 13.14 9.94 24 384660 9791 64104257
Oesophageal fibrosis 13.10 9.94 10 384674 176 64113872
Anal fistula 13.05 9.94 64 384620 5189 64108859
Delivery 13.04 9.94 16 384668 517 64113531
Ankylosing spondylitis 13.03 9.94 89 384595 8145 64105903
Anger 13.02 9.94 49 384635 15692 64098356
Presyncope 13.00 9.94 140 384544 34949 64079099
Pneumonia bacterial 12.97 9.94 46 384638 14989 64099059
Foetal exposure during pregnancy 12.93 9.94 57 384627 4419 64109629
Incoherent 12.92 9.94 14 384670 7104 64106944
Osteoporotic fracture 12.92 9.94 49 384635 3549 64110499
Increased tendency to bruise 12.89 9.94 97 384587 9158 64104890
Stress at work 12.86 9.94 22 384662 967 64113081
Graft versus host disease in skin 12.83 9.94 8 384676 5339 64108709
Coordination abnormal 12.76 9.94 46 384638 14918 64099130
Hernia 12.73 9.94 130 384554 13388 64100660
Pseudomonas infection 12.73 9.94 59 384625 17824 64096224
Hepatocellular carcinoma 12.69 9.94 19 384665 8384 64105664
Taste disorder 12.69 9.94 23 384661 9410 64104638
Retinitis 12.63 9.94 34 384650 2051 64111997
Myofascial pain syndrome 12.63 9.94 31 384653 1767 64112281
Spinal osteoarthritis 12.61 9.94 136 384548 14205 64099843
Abortion missed 12.60 9.94 24 384660 1148 64112900
Blood folate increased 12.58 9.94 15 384669 470 64113578
Skin laceration 12.50 9.94 210 384474 24207 64089841
Postpartum haemorrhage 12.43 9.94 27 384657 1420 64112628
Intracranial pressure increased 12.41 9.94 14 384670 6975 64107073
Transplant dysfunction 12.40 9.94 13 384671 6695 64107353
Skin ulcer haemorrhage 12.36 9.94 15 384669 479 64113569
Lip swelling 12.35 9.94 126 384558 31781 64082267
Threatened labour 12.29 9.94 16 384668 549 64113499
Eosinophil count increased 12.29 9.94 43 384641 14069 64099979
Cholangitis 12.28 9.94 29 384655 10773 64103275
Intervertebral disc degeneration 12.28 9.94 126 384558 12994 64101054
Mean cell volume increased 12.19 9.94 61 384623 4985 64109063
Cardiotoxicity 12.15 9.94 27 384657 10247 64103801
Hypernatraemia 12.12 9.94 35 384649 12154 64101894
Alanine aminotransferase increased 12.06 9.94 692 383992 138339 63975709
Hypotonia 12.04 9.94 31 384653 11181 64102867
Colitis microscopic 12.02 9.94 16 384668 7416 64106632
Dyslipidaemia 12.02 9.94 23 384661 9219 64104829
Erectile dysfunction 12.02 9.94 37 384647 12590 64101458
Bradypnoea 11.99 9.94 8 384676 5151 64108897
Chondropathy 11.99 9.94 36 384648 2313 64111735
Squamous cell carcinoma 11.95 9.94 131 384553 13738 64100310
Skin neoplasm excision 11.90 9.94 20 384664 866 64113182
Schizophrenia 11.90 9.94 31 384653 11137 64102911
Lip blister 11.89 9.94 35 384649 2224 64111824
Virologic failure 11.88 9.94 3 384681 3463 64110585
Hiatus hernia 11.87 9.94 176 384508 19781 64094267
Neck pain 11.83 9.94 464 384220 61069 64052979
Amylase increased 11.83 9.94 25 384659 9660 64104388
Bradykinesia 11.80 9.94 13 384671 6547 64107501
Therapy non-responder 11.77 9.94 493 384191 65406 64048642
Unevaluable event 11.77 9.94 221 384463 50268 64063780
Abdominal distension 11.66 9.94 461 384223 95533 64018515
Carpal tunnel syndrome 11.64 9.94 145 384539 15683 64098365
Memory impairment 11.63 9.94 406 384278 85276 64028772
Purpura 11.63 9.94 58 384626 17188 64096860
Myopathy 11.62 9.94 60 384624 17620 64096428
Paranoia 11.61 9.94 54 384630 16298 64097750
Hypocalcaemia 11.60 9.94 177 384507 41576 64072472
Intestinal ischaemia 11.60 9.94 33 384651 11516 64102532
Oligohydramnios 11.59 9.94 43 384641 3081 64110967
Hepatotoxicity 11.59 9.94 168 384516 39794 64074254
Myocardial ischaemia 11.59 9.94 86 384598 23165 64090883
Musculoskeletal discomfort 11.49 9.94 148 384536 16129 64097919
Sensitivity to weather change 11.49 9.94 74 384610 6640 64107408
Myelosuppression 11.47 9.94 89 384595 23741 64090307
Generalised oedema 11.44 9.94 75 384609 20778 64093270
COVID-19 pneumonia 11.42 9.94 55 384629 16449 64097599
Cataract 11.42 9.94 393 384291 50869 64063179
Hepatitis C 11.42 9.94 31 384653 10984 64103064
Vacuum extractor delivery 11.39 9.94 8 384676 123 64113925
Skin graft failure 11.39 9.94 10 384674 216 64113832
Swollen joint count 11.38 9.94 16 384668 592 64113456
Labyrinthitis 11.37 9.94 38 384646 2585 64111463
Accidental death 11.36 9.94 4 384680 3721 64110327
Complication of device insertion 11.35 9.94 8 384676 5004 64109044
Catheter management 11.32 9.94 3 384681 3352 64110696
Mesothelioma 11.31 9.94 12 384672 330 64113718
Skin necrosis 11.29 9.94 133 384551 14196 64099852
Pleural fibrosis 11.27 9.94 51 384633 3999 64110049
Mental disorder 11.27 9.94 102 384582 26343 64087705
Device leakage 11.26 9.94 20 384664 8246 64105802
Nail injury 11.25 9.94 14 384670 459 64113589
Lower respiratory tract congestion 11.19 9.94 41 384643 2920 64111128
Umbilical hernia 11.18 9.94 54 384630 4351 64109697
Sudden death 11.17 9.94 72 384612 20024 64094024
Radiation inflammation 11.16 9.94 10 384674 222 64113826
Heparin-induced thrombocytopenia 11.12 9.94 21 384663 8458 64105590
Tooth fracture 11.10 9.94 99 384585 9828 64104220
Uterine perforation 11.07 9.94 11 384673 5809 64108239
Oedema 11.06 9.94 442 384242 91493 64022555
Medical device site joint infection 11.05 9.94 10 384674 225 64113823
Feeling abnormal 11.05 9.94 668 384016 132934 63981114
Blood iron increased 11.04 9.94 25 384659 1352 64112696
Genital haemorrhage 11.02 9.94 10 384674 5512 64108536
Impaired work ability 11.01 9.94 139 384545 15080 64098968
Ventricular arrhythmia 10.97 9.94 17 384667 7398 64106650
Hypoxic-ischaemic encephalopathy 10.97 9.94 16 384668 7136 64106912
Glomerular filtration rate decreased 10.94 9.94 70 384614 19502 64094546
Pancreatic duct stenosis 10.91 9.94 10 384674 229 64113819
Speech disorder developmental 10.89 9.94 15 384669 544 64113504
Product administered to patient of inappropriate age 10.88 9.94 7 384677 4594 64109454
Troponin increased 10.84 9.94 51 384633 15348 64098700
Benign ovarian tumour 10.83 9.94 11 384673 287 64113761
Hepatic cytolysis 10.82 9.94 45 384639 14004 64100044
Failed induction of labour 10.80 9.94 10 384674 232 64113816
Drug tolerance decreased 10.70 9.94 75 384609 6923 64107125
Hydrocephalus 10.67 9.94 18 384666 7573 64106475
Personality change 10.65 9.94 22 384662 8571 64105477
Hyperhomocysteinaemia 10.64 9.94 13 384671 418 64113630
Vascular insufficiency 10.63 9.94 14 384670 486 64113562
Gastroenteritis 10.63 9.94 242 384442 29469 64084579
Nephrotic syndrome 10.63 9.94 26 384658 9541 64104507
Vascular rupture 10.60 9.94 24 384660 1298 64112750
Bundle branch block left 10.58 9.94 28 384656 10006 64104042
Salivary hypersecretion 10.49 9.94 37 384647 12076 64101972
Photophobia 10.48 9.94 153 384531 17140 64096908
Muscular weakness 10.47 9.94 637 384047 126701 63987347
Kidney transplant rejection 10.44 9.94 26 384658 9485 64104563
Diaphragmatic disorder 10.44 9.94 25 384659 1403 64112645
Hernia pain 10.43 9.94 13 384671 427 64113621
Cartilage injury 10.40 9.94 24 384660 1315 64112733
Generalised tonic-clonic seizure 10.39 9.94 171 384513 39686 64074362
Prostatic specific antigen increased 10.38 9.94 23 384661 8737 64105311
Decreased insulin requirement 10.37 9.94 8 384676 143 64113905
Inflammatory bowel disease 10.37 9.94 54 384630 4484 64109564
Peripheral venous disease 10.32 9.94 69 384615 6269 64107779
Skin infection 10.31 9.94 136 384548 14901 64099147
Dementia 10.26 9.94 77 384607 20689 64093359
Aplasia 10.23 9.94 16 384668 6937 64107111
Complication of pregnancy 10.20 9.94 11 384673 308 64113740
Crying 10.16 9.94 74 384610 20016 64094032
Haemodynamic instability 10.14 9.94 50 384634 14862 64099186
Hypercapnia 10.14 9.94 19 384665 7675 64106373
Intestinal stenosis 10.11 9.94 42 384642 3172 64110876
Mycobacterium tuberculosis complex test positive 10.10 9.94 31 384653 2016 64112032
Thiopurine methyltransferase decreased 10.09 9.94 11 384673 312 64113736
Hospitalisation 10.06 9.94 357 384327 74850 64039198
Appendix disorder 10.03 9.94 26 384658 1533 64112515
Laryngospasm 10.00 9.94 4 384680 3441 64110607
Alcohol interaction 10.00 9.94 7 384677 4394 64109654
Coronary artery bypass 9.95 9.94 12 384672 5803 64108245

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 D018977 Micronutrients
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
CHEBI has role CHEBI:22586 antioxidants
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:25212 metabolites
CHEBI has role CHEBI:61115 histone deacetylase inhibitors
CHEBI has role CHEBI:62913 PARP
CHEBI has role CHEBI:63726 neuroprotective agents
CHEBI has role CHEBI:67079 anti-inflammatory agents
CHEBI has role CHEBI:71181 Sir2 inhibitors
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:75772 S. cerevisiae metabolites
CHEBI has role CHEBI:76971 Escherichia coli metabolites
CHEBI has role CHEBI:84087 human urinary metabolites
CHEBI has role CHEBI:176497 geroprotectors

Drug Use (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)

None

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 Unclassified IC50 4.36 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 Unclassified IC50 4.40 CHEMBL
NAD-dependent protein deacetylase Unclassified IC50 4.64 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
25X51I8RD4 UNII
7405 RXNORM
4947 MMSL
5170 MMSL
5684 MMSL
72420 MMSL
d03739 MMSL
001055 NDDF
173196005 SNOMEDCT_US
D009536 MESH_DESCRIPTOR_UI
404 INN_ID

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
Vitafol Ultra 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 One Caplets 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 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 19 sections
Se-Tan PLUS HUMAN PRESCRIPTION DRUG LABEL 13 13925-118 CAPSULE, GELATIN COATED 30 ug ORAL unapproved drug other 19 sections
PRENATAL PLUS HUMAN PRESCRIPTION DRUG LABEL 15 15338-522 TABLET, FILM COATED 20 mg ORAL unapproved drug other 8 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