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

Stem definitionDrug idCAS RN
4072 50-81-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vitamin c
  • L-Ascorbic acid
  • ascorbic acid
  • ascorbic acid (vit C)
  • sodium ascorbate
  • calcium ascorbate
  • ascorbic acid, monosodium salt
A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant. NIH COVID-19 Treatment Guidelines Panel states that there are insufficient data to recommend either for or against use of ascorbic acid for the treatment of COVID-19 in critically or noncritically ill patients.
  • Molecular weight: 176.12
  • Formula: C6H8O6
  • CLOGP: -1.76
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 4
  • TPSA: 107.22
  • ALOGS: 0.14
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O
0.20 g P
0.25 g V

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 333 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 25 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 567.77 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.35 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.05 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.26 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 11.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
None FDA

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 1278.90 10.76 4420 636337 179306 62668959
Systemic lupus erythematosus 1187.69 10.76 4708 636049 204210 62644055
Completed suicide 1161.73 10.76 79 640678 145594 62702671
Glossodynia 1057.72 10.76 4082 636675 174794 62673471
Toxicity to various agents 891.66 10.76 713 640044 246537 62601728
Hand deformity 846.34 10.76 3519 637238 155938 62692327
Arthropathy 826.83 10.76 4603 636154 230189 62618076
Abdominal discomfort 788.12 10.76 5739 635018 315146 62533119
Alopecia 759.23 10.76 5913 634844 331623 62516642
Rheumatoid arthritis 734.28 10.76 4727 636030 249092 62599173
Wound 689.91 10.76 3368 637389 159895 62688370
Pain 649.15 10.76 10776 629981 729852 62118413
Joint swelling 590.39 10.76 5464 635293 322202 62526063
Maternal exposure during pregnancy 568.61 10.76 3986 636771 216076 62632189
Death 550.51 10.76 1936 638821 372445 62475820
Drug interaction 535.03 10.76 932 639825 228199 62620066
Contraindicated product administered 529.12 10.76 3885 636872 213763 62634502
Synovitis 518.02 10.76 3445 637312 183473 62664792
Swelling 516.02 10.76 4632 636125 270746 62577519
Anti-cyclic citrullinated peptide antibody positive 514.22 10.76 2430 638327 113782 62734483
Pericarditis 507.50 10.76 2646 638111 128933 62719332
Discomfort 506.91 10.76 3155 637602 164219 62684046
Intentional overdose 481.00 10.76 84 640673 74068 62774197
Infusion related reaction 476.47 10.76 4162 636595 241359 62606906
Drug abuse 449.41 10.76 92 640665 72426 62775839
Suicide attempt 331.59 10.76 101 640656 60817 62787448
Febrile neutropenia 318.11 10.76 438 640319 118011 62730254
Hepatic enzyme increased 317.65 10.76 3280 637477 199048 62649217
Duodenal ulcer perforation 313.08 10.76 1720 639037 85489 62762776
Helicobacter infection 308.04 10.76 1792 638965 90993 62757272
Product use issue 306.48 10.76 3489 637268 217031 62631234
Rheumatoid factor positive 305.21 10.76 1668 639089 82738 62765527
Cardiac arrest 290.21 10.76 303 640454 92242 62756023
Acute kidney injury 284.73 10.76 1529 639228 261886 62586379
Arthralgia 278.74 10.76 7621 633136 562089 62286176
Psoriatic arthropathy 265.49 10.76 1707 639050 89813 62758452
Neutropenia 230.73 10.76 945 639812 174060 62674205
Overdose 219.88 10.76 525 640232 114553 62733712
Electrocardiogram QT prolonged 210.08 10.76 175 640582 59355 62788910
Malignant neoplasm progression 207.34 10.76 317 640440 81804 62766461
Musculoskeletal stiffness 206.42 10.76 2805 637952 181813 62666452
Fatigue 205.40 10.76 10933 629824 877095 61971170
Nasopharyngitis 194.66 10.76 3626 637131 250631 62597634
Therapeutic product effect decreased 192.33 10.76 2876 637881 190311 62657954
Hypersensitivity 186.49 10.76 4061 636696 288624 62559641
Cardiac failure 185.55 10.76 388 640369 88754 62759511
Disease progression 184.52 10.76 628 640129 122130 62726135
Hip arthroplasty 184.05 10.76 959 639798 46687 62801578
Lactic acidosis 183.67 10.76 78 640679 38209 62810056
Knee arthroplasty 181.18 10.76 1049 639708 53157 62795108
Hyponatraemia 181.03 10.76 554 640203 111346 62736919
Drug reaction with eosinophilia and systemic symptoms 175.48 10.76 61 640696 33775 62814490
Exposure during pregnancy 172.88 10.76 2361 638396 153186 62695079
Lower respiratory tract infection 167.96 10.76 2058 638699 130249 62718016
Impaired healing 160.05 10.76 1661 639096 100881 62747384
Sinusitis 158.02 10.76 3187 637570 223466 62624799
Bradycardia 154.70 10.76 316 640441 72911 62775354
Sopor 153.04 10.76 21 640736 22143 62826122
Rhabdomyolysis 152.87 10.76 131 640626 43820 62804445
Renal failure 152.70 10.76 639 640118 117013 62731252
Drug intolerance 151.19 10.76 4132 636625 304529 62543736
Depressed level of consciousness 148.80 10.76 248 640509 61830 62786435
Intentional self-injury 144.53 10.76 40 640717 25647 62822618
Respiratory arrest 142.04 10.76 76 640681 32569 62815696
Cardio-respiratory arrest 140.52 10.76 243 640514 59716 62788549
Treatment failure 135.14 10.76 2788 637969 196255 62652010
Rheumatic fever 134.88 10.76 820 639937 42291 62805974
Agitation 133.92 10.76 249 640508 59508 62788757
Tachycardia 131.86 10.76 678 640079 117478 62730787
Rash 130.78 10.76 6914 633843 553957 62294308
Nausea 127.09 10.76 7195 633562 847276 62000989
Hypotension 124.37 10.76 1968 638789 270636 62577629
Hypoglycaemia 122.84 10.76 264 640493 59801 62788464
Folliculitis 122.79 10.76 1166 639591 69151 62779114
Metabolic acidosis 121.59 10.76 166 640591 44903 62803362
Drug hypersensitivity 120.56 10.76 2309 638448 308378 62539887
Swollen joint count increased 120.00 10.76 697 640060 35357 62812908
Muscle injury 119.85 10.76 1095 639662 64250 62784015
Serotonin syndrome 118.73 10.76 71 640686 28611 62819654
Red blood cell sedimentation rate abnormal 117.04 10.76 452 640305 19330 62828935
Peripheral swelling 116.84 10.76 3512 637245 262430 62585835
Renal impairment 116.42 10.76 477 640280 87878 62760387
Thrombocytopenia 114.30 10.76 975 639782 150182 62698083
Sickle cell anaemia with crisis 114.14 10.76 212 640545 5791 62842474
Blister 113.72 10.76 1892 638865 127922 62720343
Somnolence 109.61 10.76 1213 639544 177472 62670793
Syncope 106.81 10.76 719 640038 116666 62731599
Immunodeficiency 106.42 10.76 446 640311 19808 62828457
Hepatic failure 103.79 10.76 124 640633 35532 62812733
Sleep disorder due to general medical condition, insomnia type 103.49 10.76 890 639867 51327 62796938
Anaemia 103.00 10.76 2217 638540 291213 62557052
Drug dependence 102.20 10.76 60 640697 24423 62823842
Psoriasis 101.53 10.76 1332 639425 85625 62762640
Irritable bowel syndrome 101.13 10.76 1274 639483 81138 62767127
Coma 98.22 10.76 327 640430 64037 62784228
Osteoarthritis 98.14 10.76 1428 639329 93915 62754350
Hepatic function abnormal 98 10.76 139 640618 37003 62811262
Multiple organ dysfunction syndrome 97.54 10.76 273 640484 56479 62791786
Dyspnoea 97.08 10.76 5574 635183 655739 62192526
Seizure 95.64 10.76 866 639891 131768 62716497
Hepatocellular injury 94.75 10.76 82 640675 27299 62820966
Fibromyalgia 94.36 10.76 1233 639524 79187 62769078
Altered state of consciousness 91.71 10.76 72 640685 25158 62823107
Arthritis 91.26 10.76 1661 639096 114260 62734005
Respiratory failure 91.12 10.76 627 640130 101231 62747034
Hyperkalaemia 90.76 10.76 264 640493 53939 62794326
Angioedema 89.85 10.76 221 640536 47744 62800521
No adverse event 89.73 10.76 176 640581 41229 62807036
Drug resistance 89.13 10.76 61 640696 22872 62825393
Cholestasis 88.21 10.76 100 640657 29334 62818931
Cytomegalovirus infection 87.94 10.76 51 640706 20901 62827364
Leukopenia 87.06 10.76 442 640315 76848 62771417
Tremor 86.62 10.76 884 639873 131355 62716910
Blood cholesterol increased 85.11 10.76 1378 639379 92654 62755611
C-reactive protein abnormal 81.27 10.76 766 639991 45330 62802935
Poisoning 79.61 10.76 20 640737 13680 62834585
Device expulsion 79.59 10.76 144 640613 34778 62813487
Contusion 78.00 10.76 2025 638732 148019 62700246
Night sweats 77.68 10.76 794 639963 48020 62800245
Anaphylactic reaction 75.59 10.76 376 640381 65724 62782541
Metastases to bone 73.89 10.76 62 640695 20957 62827308
Hypoxia 73.13 10.76 332 640425 59460 62788805
Pregnancy 73.06 10.76 628 640129 36208 62812057
Hyperglycaemia 72.99 10.76 200 640557 41667 62806598
Drug ineffective for unapproved indication 72.78 10.76 146 640611 33917 62814348
Hallucination 72.16 10.76 296 640461 54521 62793744
Encephalopathy 71.51 10.76 179 640578 38441 62809824
Anaphylactic shock 71.14 10.76 80 640677 23553 62824712
Bursitis 71.13 10.76 627 640130 36414 62811851
Temperature regulation disorder 70.90 10.76 177 640580 5955 62842310
Vomiting 69.47 10.76 4789 635968 554828 62293437
Muscle spasticity 69.09 10.76 416 640341 21378 62826887
Loss of consciousness 68.44 10.76 812 639945 117309 62730956
Torsade de pointes 67.64 10.76 25 640732 13326 62834939
Suicidal ideation 66.92 10.76 363 640394 62058 62786207
Weight increased 66.91 10.76 3246 637511 257546 62590719
Shock 66.80 10.76 83 640674 23380 62824885
Ill-defined disorder 66.64 10.76 1178 639579 80577 62767688
Intentional product misuse 66.00 10.76 353 640404 60564 62787701
Drug withdrawal syndrome 65.75 10.76 108 640649 27086 62821179
Ear pain 65.58 10.76 604 640153 35514 62812751
Disorientation 65.43 10.76 193 640564 39259 62809006
Carpal tunnel syndrome 65.13 10.76 396 640361 20421 62827844
Hypokalaemia 65.08 10.76 701 640056 103103 62745162
Neoplasm progression 65.02 10.76 172 640585 36256 62812009
Ejection fraction decreased 64.64 10.76 78 640679 22254 62826011
Acute hepatic failure 64.49 10.76 54 640703 18273 62829992
Sedation 64.26 10.76 190 640567 38619 62809646
Sensitisation 63.65 10.76 119 640638 3267 62844998
Disseminated intravascular coagulation 63.58 10.76 59 640698 18992 62829273
Drug level increased 63.10 10.76 82 640675 22654 62825611
Blood creatine phosphokinase increased 62.00 10.76 134 640623 30296 62817969
Ventricular tachycardia 61.94 10.76 66 640691 19913 62828352
Metastases to liver 61.83 10.76 89 640668 23550 62824715
Liver injury 61.29 10.76 904 639853 59616 62788649
Product use in unapproved indication 61.04 10.76 1359 639398 177721 62670544
Anxiety 60.87 10.76 1700 639057 215841 62632424
Extrapyramidal disorder 60.68 10.76 29 640728 13255 62835010
Osteonecrosis of jaw 60.32 10.76 169 640588 34954 62813311
Intentional product use issue 59.90 10.76 1703 639054 126189 62722076
Blood pressure fluctuation 59.81 10.76 723 640034 45594 62802671
Gamma-glutamyltransferase increased 59.74 10.76 162 640595 33869 62814396
Loss of personal independence in daily activities 59.60 10.76 1343 639414 95947 62752318
Diabetic ketoacidosis 58.94 10.76 72 640685 20433 62827832
Inappropriate antidiuretic hormone secretion 58.93 10.76 42 640715 15420 62832845
Joint effusion 58.85 10.76 333 640424 16727 62831538
Product quality issue 57.65 10.76 178 640579 35687 62812578
Myocardial infarction 57.36 10.76 688 640069 99205 62749060
Palmar-plantar erythrodysaesthesia syndrome 56.96 10.76 90 640667 22925 62825340
Mydriasis 56.32 10.76 25 640732 11931 62836334
Hypothermia 55.67 10.76 34 640723 13547 62834718
Blood pressure diastolic abnormal 55.66 10.76 292 640465 14250 62834015
Blood bilirubin increased 55.09 10.76 191 640566 36949 62811316
Schizophrenia 55.05 10.76 16 640741 9936 62838329
Body temperature increased 54.96 10.76 596 640161 36596 62811669
Type 2 diabetes mellitus 54.84 10.76 928 639829 62940 62785325
Ejection fraction 54.83 10.76 92 640665 2314 62845951
Polycystic ovaries 54.82 10.76 132 640625 4339 62843926
Blood pressure systolic abnormal 54.16 10.76 273 640484 13113 62835152
Neuroleptic malignant syndrome 54.03 10.76 27 640730 12029 62836236
Hepatotoxicity 53.93 10.76 192 640565 36849 62811416
Disability assessment scale score increased 53.90 10.76 108 640649 3125 62845140
Sepsis 53.62 10.76 1157 639600 151966 62696299
Femur fracture 53.13 10.76 650 640107 41106 62807159
Abortion spontaneous 53.02 10.76 718 640039 46477 62801788
Cardiac failure congestive 52.93 10.76 637 640120 91796 62756469
Osteoporosis 52.89 10.76 843 639914 56495 62791770
Abnormal behaviour 52.83 10.76 84 640673 21342 62826923
Respiratory depression 52.61 10.76 37 640720 13678 62834587
Dysarthria 52.32 10.76 237 640520 42474 62805791
Akathisia 51.91 10.76 14 640743 9132 62839133
Live birth 51.90 10.76 439 640318 25191 62823074
Posterior reversible encephalopathy syndrome 51.90 10.76 59 640698 17286 62830979
Cytokine release syndrome 51.83 10.76 41 640716 14273 62833992
Eosinophilia 51.71 10.76 94 640663 22662 62825603
Wrong technique in product usage process 50.80 10.76 394 640363 61946 62786319
Dizziness 50.51 10.76 3696 637061 426229 62422036
Parkinsonism 50.49 10.76 21 640736 10418 62837847
Psychotic disorder 50.12 10.76 116 640641 25596 62822669
Polyneuropathy 50.10 10.76 44 640713 14545 62833720
Hyperhidrosis 49.59 10.76 777 639980 107059 62741206
Neurotoxicity 49.53 10.76 59 640698 16931 62831334
Dehydration 49.43 10.76 1351 639406 172003 62676262
Accidental exposure to product 49.21 10.76 129 640628 27276 62820989
Macular degeneration 49.12 10.76 108 640649 24268 62823997
Blood creatinine increased 48.55 10.76 610 640147 87234 62761031
Agranulocytosis 48.50 10.76 114 640643 25020 62823245
Thrombotic microangiopathy 48.32 10.76 23 640734 10538 62837727
Foot deformity 48.17 10.76 461 640296 27392 62820873
Unresponsive to stimuli 48.09 10.76 177 640580 33639 62814626
Neutrophil count decreased 48.09 10.76 352 640405 56054 62792211
Neuropathy peripheral 47.99 10.76 832 639925 112835 62735430
Diarrhoea 47.97 10.76 6408 634349 708958 62139307
Coeliac disease 47.63 10.76 255 640502 12542 62835723
Myalgia 47.38 10.76 1121 639636 145408 62702857
Basal cell carcinoma 46.80 10.76 460 640297 27531 62820734
Haematotoxicity 46.76 10.76 18 640739 9358 62838907
Condition aggravated 46.66 10.76 4688 636069 397529 62450736
Acute generalised exanthematous pustulosis 46.61 10.76 27 640730 11072 62837193
Pyrexia 46.60 10.76 4101 636656 466377 62381888
Cerebral haemorrhage 46.27 10.76 157 640600 30572 62817693
Blood glucose increased 45.77 10.76 583 640174 83173 62765092
Food allergy 45.77 10.76 232 640525 11169 62837096
Transplant rejection 45.59 10.76 26 640731 10754 62837511
Dysphagia 45.35 10.76 625 640132 87960 62760305
Grip strength decreased 45.27 10.76 382 640375 21905 62826360
Restlessness 44.68 10.76 150 640607 29303 62818962
Multiple fractures 44.67 10.76 189 640568 8429 62839836
Device difficult to use 44.66 10.76 38 640719 12758 62835507
Toxic skin eruption 44.08 10.76 39 640718 12846 62835419
Juvenile idiopathic arthritis 43.83 10.76 101 640656 3225 62845040
Disturbance in attention 43.79 10.76 217 640540 37972 62810293
Diabetes mellitus inadequate control 43.60 10.76 53 640704 15073 62833192
Ascites 43.02 10.76 238 640519 40490 62807775
Off label use 43.01 10.76 6060 634697 668402 62179863
Myelosuppression 42.24 10.76 112 640645 23591 62824674
Joint laxity 41.91 10.76 83 640674 2381 62845884
Injection site erythema 41.88 10.76 1118 639639 82056 62766209
Obstructive airways disorder 41.47 10.76 92 640665 20607 62827658
Pancreatitis acute 41.45 10.76 138 640619 27028 62821237
Hypomania 41.41 10.76 7 640750 6323 62841942
Dyskinesia 41.37 10.76 174 640583 31828 62816437
Face oedema 41.18 10.76 89 640668 20123 62828142
Mental status changes 40.96 10.76 233 640524 39366 62808899
Dystonia 40.28 10.76 48 640709 13771 62834494
Respiratory distress 40.04 10.76 191 640566 33760 62814505
Red blood cell sedimentation rate increased 39.94 10.76 645 640112 43337 62804928
Stomatitis 39.69 10.76 1746 639011 136979 62711286
Stress cardiomyopathy 39.66 10.76 23 640734 9427 62838838
Post transplant lymphoproliferative disorder 39.29 10.76 3 640754 5028 62843237
Exposure to toxic agent 39.27 10.76 5 640752 5582 62842683
Status epilepticus 39.21 10.76 58 640699 15175 62833090
Drug use disorder 38.84 10.76 3 640754 4981 62843284
Metastases to central nervous system 38.75 10.76 45 640712 13060 62835205
Accidental overdose 38.67 10.76 114 640643 23195 62825070
Miosis 38.57 10.76 13 640744 7340 62840925
Chest discomfort 38.17 10.76 832 639925 109137 62739128
Blood pressure decreased 38.02 10.76 446 640311 64576 62783689
Speech disorder 37.87 10.76 247 640510 40382 62807883
Haemophagocytic lymphohistiocytosis 37.78 10.76 31 640726 10596 62837669
Chronic kidney disease 37.42 10.76 286 640471 45112 62803153
Jaundice 37.22 10.76 160 640597 29091 62819174
Palpitations 37.21 10.76 860 639897 111910 62736355
Mania 37.07 10.76 42 640715 12325 62835940
Arrhythmia 37.02 10.76 229 640528 37911 62810354
Ventricular fibrillation 37.01 10.76 39 640718 11828 62836437
Melaena 36.89 10.76 169 640588 30196 62818069
Aggression 36.80 10.76 118 640639 23380 62824885
Bone marrow failure 36.79 10.76 161 640596 29129 62819136
Rash maculo-papular 36.71 10.76 181 640576 31715 62816550
Blood alkaline phosphatase increased 36.69 10.76 268 640489 42699 62805566
Hypomagnesaemia 36.07 10.76 158 640599 28579 62819686
Cerebral infarction 36.03 10.76 122 640635 23771 62824494
Proteinuria 36.02 10.76 88 640669 19057 62829208
Stevens-Johnson syndrome 35.87 10.76 130 640627 24820 62823445
Injection site reaction 35.87 10.76 808 639949 57716 62790549
Ischaemic stroke 35.82 10.76 80 640677 17877 62830388
Joint range of motion decreased 35.47 10.76 491 640266 31937 62816328
Multiple sclerosis relapse 35.14 10.76 316 640441 48162 62800103
Ear infection 34.93 10.76 561 640196 37652 62810613
Cardiogenic shock 34.87 10.76 81 640676 17851 62830414
Myoclonus 34.77 10.76 67 640690 15801 62832464
Joint destruction 34.68 10.76 140 640617 6112 62842153
Gastrointestinal disorder 34.55 10.76 1638 639119 129601 62718664
Metastases to lung 34.35 10.76 47 640710 12703 62835562
Pulmonary oedema 34.20 10.76 371 640386 54502 62793763
Brain oedema 33.74 10.76 57 640700 14138 62834127
Acute myeloid leukaemia 33.71 10.76 77 640680 17070 62831195
Haemorrhage intracranial 33.66 10.76 52 640705 13367 62834898
Bronchospasm 33.64 10.76 78 640679 17202 62831063
Pulmonary arterial hypertension 33.55 10.76 116 640641 22461 62825804
Muscle rigidity 33.46 10.76 40 640717 11460 62836805
Atrioventricular block complete 33.35 10.76 21 640736 8230 62840035
Mobility decreased 33.14 10.76 1518 639239 119641 62728624
Blood pressure systolic increased 33.12 10.76 667 640090 46730 62801535
Aspartate aminotransferase increased 33.09 10.76 677 640080 89600 62758665
Withdrawal syndrome 33.03 10.76 98 640659 19899 62828366
Coagulopathy 32.99 10.76 102 640655 20442 62827823
Pleural effusion 32.99 10.76 703 640054 92507 62755758
Alanine aminotransferase increased 32.67 10.76 797 639960 102973 62745292
Cognitive disorder 32.58 10.76 383 640374 55432 62792833
Injection site pruritus 32.56 10.76 638 640119 44478 62803787
Second primary malignancy 32.48 10.76 20 640737 7933 62840332
Device use error 32.35 10.76 9 640748 5752 62842513
Pain in extremity 32.34 10.76 3820 636937 327666 62520599
Vision blurred 32.33 10.76 694 640063 91230 62757035
Malaise 32.26 10.76 3690 637067 412264 62436001
Tumour lysis syndrome 32.24 10.76 26 640731 8964 62839301
Bronchopulmonary aspergillosis 32.20 10.76 24 640733 8611 62839654
Hepatic cytolysis 32.09 10.76 67 640690 15340 62832925
Neck deformity 32.01 10.76 68 640689 2053 62846212
Sinus tachycardia 31.96 10.76 131 640626 24137 62824128
Febrile bone marrow aplasia 31.94 10.76 17 640740 7308 62840957
Infection 31.94 10.76 2707 638050 226466 62621799
Haemorrhage 31.78 10.76 429 640328 60593 62787672
Polyarthritis 31.73 10.76 193 640564 9953 62838312
Delirium 31.39 10.76 342 640415 50199 62798066
Product administration error 31.35 10.76 118 640639 22279 62825986
Disease recurrence 31.15 10.76 161 640596 27869 62820396
Anuria 31.14 10.76 49 640708 12502 62835763
Colitis 31.09 10.76 326 640431 48202 62800063
Hemiparesis 31.09 10.76 125 640632 23157 62825108
Acute graft versus host disease 31.04 10.76 4 640753 4424 62843841
Nightmare 31.03 10.76 95 640662 19099 62829166
Bone erosion 31.02 10.76 294 640463 17423 62830842
Paradoxical drug reaction 31.00 10.76 3 640754 4149 62844116
Tachypnoea 30.64 10.76 82 640675 17220 62831045
Asphyxia 30.60 10.76 12 640745 6169 62842096
Graft versus host disease 30.53 10.76 15 640742 6748 62841517
Caesarean section 30.50 10.76 284 640473 16748 62831517
Constipation 30.32 10.76 1910 638847 223033 62625232
Toxic epidermal necrolysis 30.18 10.76 142 640615 25192 62823073
Mucosal inflammation 30.17 10.76 315 640442 46613 62801652
Hallucination, auditory 30.01 10.76 52 640705 12772 62835493
Substance abuse 29.98 10.76 6 640751 4801 62843464
Disability 29.94 10.76 300 640457 18047 62830218
Urinary retention 29.89 10.76 181 640576 30120 62818145
Cerebrovascular accident 29.71 10.76 846 639911 107178 62741087
Pain in jaw 29.61 10.76 288 640469 43208 62805057
Platelet count decreased 29.56 10.76 919 639838 115203 62733062
Hallucination, visual 29.46 10.76 98 640659 19200 62829065
Pulmonary fibrosis 29.43 10.76 565 640192 39244 62809021
Inflammation 29.22 10.76 1060 639697 81213 62767052
Gastrointestinal haemorrhage 29.09 10.76 611 640146 80565 62767700
Vertigo 29.06 10.76 427 640330 59460 62788805
Labelled drug-drug interaction medication error 28.99 10.76 57 640700 13342 62834923
Erythema multiforme 28.92 10.76 36 640721 10133 62838132
Pulmonary embolism 28.84 10.76 927 639830 115757 62732508
Drug tolerance decreased 28.65 10.76 286 640471 17187 62831078
Breast cancer stage I 28.58 10.76 17 640740 6872 62841393
Gestational diabetes 28.38 10.76 163 640594 8233 62840032
Cardiotoxicity 28.32 10.76 26 640731 8412 62839853
Maternal drugs affecting foetus 27.98 10.76 116 640641 5126 62843139
Hypocalcaemia 27.96 10.76 196 640561 31517 62816748
Circulatory collapse 27.91 10.76 120 640637 21818 62826447
Bradyphrenia 27.89 10.76 18 640739 6962 62841303
Blood pressure diastolic decreased 27.83 10.76 351 640406 22355 62825910
International normalised ratio increased 27.31 10.76 318 640439 46107 62802158
Therapy partial responder 27.02 10.76 41 640716 10617 62837648
Myocarditis 26.88 10.76 39 640718 10286 62837979
Aphasia 26.68 10.76 209 640548 32791 62815474
Haematoma 26.56 10.76 224 640533 34596 62813669
Dyspnoea exertional 26.54 10.76 438 640319 59864 62788401
Laryngitis 26.52 10.76 275 640482 16692 62831573
Sinus bradycardia 26.50 10.76 68 640689 14483 62833782
Swollen tongue 26.48 10.76 224 640533 34576 62813689
Tardive dyskinesia 26.45 10.76 28 640729 8474 62839791
Atrial fibrillation 26.40 10.76 937 639820 115699 62732566
Asthenia 26.34 10.76 3430 637327 380174 62468091
Diabetes mellitus 26.03 10.76 401 640356 55409 62792856
Angina pectoris 25.97 10.76 187 640570 29891 62818374
Nephrectomy 25.89 10.76 51 640706 1457 62846808
Acidosis 25.88 10.76 46 640711 11187 62837078
Abdominal pain 25.84 10.76 2580 638177 290876 62557389
Septic shock 25.82 10.76 495 640262 66134 62782131
Acute respiratory distress syndrome 25.69 10.76 136 640621 23398 62824867
Tenderness 25.56 10.76 344 640413 22234 62826031
Schizoaffective disorder 25.50 10.76 3 640754 3559 62844706
Cytopenia 25.40 10.76 49 640708 11552 62836713
Tubulointerstitial nephritis 25.24 10.76 109 640648 19794 62828471
Cyanosis 25.17 10.76 87 640670 16848 62831417
Joint stiffness 25.01 10.76 576 640181 41293 62806972
Lip swelling 24.99 10.76 197 640560 30866 62817399
Nasal polyps 24.92 10.76 15 640742 6024 62842241
Pathogen resistance 24.89 10.76 17 640740 6381 62841884
Heart rate decreased 24.85 10.76 619 640138 44941 62803324
Aspergillus infection 24.79 10.76 27 640730 8066 62840199
Injection site swelling 24.68 10.76 642 640115 46930 62801335
Haemoptysis 24.61 10.76 179 640578 28547 62819718
Personality disorder 24.59 10.76 14 640743 5797 62842468
Hepatitis cholestatic 24.53 10.76 20 640737 6858 62841407
Psychomotor hyperactivity 24.27 10.76 44 640713 10619 62837646
Ventricular septal defect 24.25 10.76 98 640659 4280 62843985
Intramedullary rod insertion 24.25 10.76 61 640696 2062 62846203
Premature labour 24.18 10.76 212 640545 12292 62835973
Muscle twitching 24.17 10.76 109 640648 19559 62828706
Adverse event 24.13 10.76 871 639886 66688 62781577
Genital haemorrhage 24.12 10.76 23 640734 7309 62840956
Device related infection 23.99 10.76 138 640619 23254 62825011
Pulmonary hypertension 23.94 10.76 249 640508 36874 62811391
Immune reconstitution inflammatory syndrome 23.89 10.76 16 640741 6068 62842197
Blood pressure diastolic increased 23.85 10.76 178 640579 9832 62838433
Chest pain 23.80 10.76 1866 638891 214093 62634172
Decreased appetite 23.53 10.76 2197 638560 248855 62599410
Epstein-Barr virus infection 23.42 10.76 28 640729 8022 62840243
Pancreatitis 23.38 10.76 351 640406 48704 62799561
Limb deformity 23.31 10.76 91 640666 3911 62844354
Transplant dysfunction 23.24 10.76 10 640747 4862 62843403
Tuberculosis 23.22 10.76 193 640564 11018 62837247
Cardiomyopathy 23.11 10.76 95 640662 17489 62830776
Oliguria 23.09 10.76 35 640722 9066 62839199
Bradypnoea 23.06 10.76 4 640753 3546 62844719
Pemphigoid 23.06 10.76 24 640733 7320 62840945
Interstitial lung disease 23.06 10.76 463 640294 61445 62786820
Depressed mood 22.99 10.76 277 640480 39914 62808351
Jaundice cholestatic 22.92 10.76 24 640733 7300 62840965
Deafness transitory 22.92 10.76 57 640700 1913 62846352
BK virus infection 22.89 10.76 3 640754 3276 62844989
Nodule 22.85 10.76 318 640439 20708 62827557
Ketoacidosis 22.51 10.76 8 640749 4370 62843895
Forced expiratory volume decreased 22.45 10.76 11 640746 4957 62843308
Sexual dysfunction 22.36 10.76 8 640749 4351 62843914
Synovial cyst 22.35 10.76 181 640576 10252 62838013
Prescribed overdose 22.35 10.76 476 640281 33677 62814588
Hepatitis acute 22.25 10.76 36 640721 9084 62839181
Panic attack 22.24 10.76 133 640624 22198 62826067
Acute pulmonary oedema 22.05 10.76 30 640727 8128 62840137
Rotator cuff repair 22.00 10.76 59 640698 2075 62846190
Irritability 21.93 10.76 209 640548 31485 62816780
Prescribed underdose 21.82 10.76 421 640336 29268 62818997
Rheumatoid nodule 21.80 10.76 267 640490 16888 62831377
Gastroenteritis viral 21.68 10.76 348 640409 23352 62824913
Transaminases increased 21.64 10.76 207 640550 31160 62817105
Latent tuberculosis 21.63 10.76 67 640690 2560 62845705
Hepatitis B reactivation 21.59 10.76 3 640754 3134 62845131
Wheelchair user 21.57 10.76 123 640634 6196 62842069
Maternal exposure before pregnancy 21.53 10.76 141 640616 7462 62840803
Bone density decreased 21.51 10.76 234 640523 14378 62833887
Product prescribing error 21.48 10.76 166 640591 26123 62822142
Neutropenic colitis 21.21 10.76 3 640754 3092 62845173
Pulmonary congestion 21.12 10.76 97 640660 17321 62830944
Multiple-drug resistance 21.11 10.76 13 640744 5157 62843108
Glycosylated haemoglobin increased 21.03 10.76 60 640697 12338 62835927
Depression 21.00 10.76 1702 639055 194790 62653475
Pericardial effusion 20.89 10.76 198 640559 29860 62818405
Hemiplegia 20.75 10.76 39 640718 9284 62838981
Joint dislocation 20.70 10.76 285 640472 18515 62829750
Cytomegalovirus viraemia 20.68 10.76 16 640741 5633 62842632
Paralysis 20.66 10.76 43 640714 9857 62838408
Shock haemorrhagic 20.64 10.76 43 640714 9852 62838413
Pallor 20.55 10.76 203 640554 30365 62817900
Smear cervix abnormal 20.54 10.76 71 640686 2875 62845390
Upper respiratory tract infection 20.52 10.76 1019 639738 81028 62767237
Delusion 20.50 10.76 58 640699 11959 62836306
Foot operation 20.41 10.76 134 640623 7097 62841168
Graft versus host disease in gastrointestinal tract 20.31 10.76 4 640753 3237 62845028
Hypertransaminasaemia 20.30 10.76 22 640735 6587 62841678
Hyperprolactinaemia 20.27 10.76 7 640750 3893 62844372
Neck mass 20.24 10.76 81 640676 3522 62844743
Lethargy 20.22 10.76 421 640336 55586 62792679
Wound infection 20.20 10.76 316 640441 21094 62827171
Cardiac failure acute 20.18 10.76 41 640716 9482 62838783
Peripheral venous disease 20.15 10.76 242 640515 15235 62833030
Ejection fraction abnormal 20.09 10.76 51 640706 1734 62846531
Respiratory acidosis 19.92 10.76 23 640734 6692 62841573
Lymphocyte count decreased 19.90 10.76 202 640555 30055 62818210
Bradykinesia 19.89 10.76 14 640743 5174 62843091
Clostridium difficile colitis 19.70 10.76 124 640633 20445 62827820
Renal injury 19.70 10.76 41 640716 9398 62838867
Hypernatraemia 19.55 10.76 29 640728 7580 62840685
Peripheral sensory neuropathy 19.54 10.76 28 640729 7423 62840842
Graft versus host disease in skin 19.48 10.76 3 640754 2902 62845363
Acute coronary syndrome 19.48 10.76 46 640711 10080 62838185
Lymphopenia 19.40 10.76 107 640650 18220 62830045
Affective disorder 19.39 10.76 20 640737 6126 62842139
Enthesopathy 19.31 10.76 151 640606 8463 62839802
Fracture delayed union 19.23 10.76 61 640696 2361 62845904
Malignant mediastinal neoplasm 19.15 10.76 44 640713 1402 62846863
Haemodynamic instability 19.11 10.76 40 640717 9150 62839115
Subdural haematoma 19.08 10.76 77 640680 14251 62834014
Respiratory disorder 19.00 10.76 523 640234 38559 62809706
Premature rupture of membranes 18.93 10.76 100 640657 4893 62843372
Hyperthermia 18.92 10.76 40 640717 9116 62839149
Orthostatic hypotension 18.90 10.76 254 640503 35906 62812359
Subarachnoid haemorrhage 18.87 10.76 77 640680 14206 62834059
Arthritis infective 18.87 10.76 121 640636 6357 62841908
Paranoia 18.74 10.76 58 640699 11621 62836644
Musculoskeletal pain 18.72 10.76 1124 639633 91153 62757112
Injection site pain 18.66 10.76 1537 639220 128263 62720002
Coronary artery disease 18.57 10.76 223 640534 32154 62816111
Hallucinations, mixed 18.56 10.76 13 640744 4816 62843449
Product administered to patient of inappropriate age 18.55 10.76 5 640752 3263 62845002
Acute myocardial infarction 18.52 10.76 221 640536 31903 62816362
Small for dates baby 18.47 10.76 81 640676 3670 62844595
Hospitalisation 18.46 10.76 687 640070 84394 62763871
Flushing 18.44 10.76 597 640160 74490 62773775
Laryngospasm 18.43 10.76 4 640753 3024 62845241
Complication of device insertion 18.32 10.76 30 640727 7534 62840731
Body tinea 18.32 10.76 51 640706 1834 62846431
Skin cancer 18.29 10.76 187 640570 11308 62836957
Foetal exposure during pregnancy 18.26 10.76 437 640320 31525 62816740
Bone pain 18.21 10.76 416 640341 54225 62794040
Treatment noncompliance 18.15 10.76 266 640491 37059 62811206
Dermatitis exfoliative 18.11 10.76 17 640740 5442 62842823
Generalised oedema 18.06 10.76 90 640667 15728 62832537
Blood test abnormal 18.06 10.76 239 640518 15390 62832875
Injection site bruising 17.95 10.76 552 640205 41358 62806907
Ankylosing spondylitis 17.93 10.76 173 640584 10301 62837964
Confusional state 17.89 10.76 2100 638657 234280 62613985
Right ventricular failure 17.84 10.76 101 640656 17087 62831178
Neurologic neglect syndrome 17.82 10.76 3 640754 2718 62845547
Skin papilloma 17.81 10.76 98 640659 4871 62843394
Pneumonia viral 17.75 10.76 33 640724 7889 62840376
Pre-eclampsia 17.74 10.76 155 640602 8978 62839287
Product substitution issue 17.71 10.76 92 640665 15904 62832361
Inadequate analgesia 17.68 10.76 4 640753 2939 62845326
Haematemesis 17.62 10.76 209 640548 30203 62818062
Tenosynovitis stenosans 17.61 10.76 74 640683 3290 62844975
Oral herpes 17.58 10.76 365 640392 25709 62822556
Adenovirus infection 17.57 10.76 7 640750 3564 62844701
Lupus vasculitis 17.52 10.76 25 640732 544 62847721
Hyperuricaemia 17.49 10.76 17 640740 5353 62842912
Malignant melanoma 17.25 10.76 183 640574 11173 62837092
Wrong product administered 17.19 10.76 22 640735 6119 62842146
Spinal stenosis 17.15 10.76 228 640529 14697 62833568
Chronic graft versus host disease 17.14 10.76 5 640752 3097 62845168
Polyuria 17.08 10.76 38 640719 8504 62839761
Eosinophil count increased 17.02 10.76 55 640702 10873 62837392
Myopathy 16.97 10.76 57 640700 11134 62837131
Diabetes insipidus 16.96 10.76 3 640754 2622 62845643
Hyperbilirubinaemia 16.90 10.76 58 640699 11256 62837009
Emotional distress 16.88 10.76 229 640528 32320 62815945
Facet joint syndrome 16.79 10.76 192 640565 11946 62836319
Affect lability 16.77 10.76 57 640700 11094 62837171
Metastases to meninges 16.75 10.76 3 640754 2599 62845666
Ileus 16.69 10.76 84 640673 14641 62833624
Localised infection 16.64 10.76 411 640346 29799 62818466
Exostosis 16.61 10.76 263 640494 17599 62830666
Dysmorphism 16.59 10.76 56 640701 2240 62846025
Personality change 16.57 10.76 28 640729 6945 62841320
Infection susceptibility increased 16.56 10.76 75 640682 3446 62844819
C-reactive protein increased 16.55 10.76 1139 639618 93568 62754697
Intracranial pressure increased 16.50 10.76 17 640740 5210 62843055
Crystal nephropathy 16.49 10.76 32 640725 904 62847361
Hyperthyroidism 16.46 10.76 84 640673 14589 62833676
Skin toxicity 16.45 10.76 14 640743 4700 62843565
Injection site rash 16.39 10.76 274 640483 18535 62829730
Carotid artery thrombosis 16.39 10.76 4 640753 2790 62845475
Disturbance in social behaviour 16.36 10.76 10 640747 3983 62844282
Obesity 16.35 10.76 407 640350 29545 62818720
Blood lactic acid increased 16.34 10.76 29 640728 7057 62841208
Developmental hip dysplasia 16.28 10.76 40 640717 1332 62846933
Pulseless electrical activity 16.27 10.76 32 640725 7489 62840776
Epilepsy 16.07 10.76 185 640572 26880 62821385
Acute respiratory failure 16.00 10.76 248 640509 34237 62814028
Catatonia 15.99 10.76 13 640744 4464 62843801
Dislocation of vertebra 15.97 10.76 145 640612 8490 62839775
Device dislocation 15.93 10.76 174 640583 25531 62822734
Placental disorder 15.93 10.76 42 640715 1462 62846803
Complication of device removal 15.92 10.76 17 640740 5125 62843140
Leukocytosis 15.90 10.76 176 640581 25759 62822506
Electrocardiogram QRS complex prolonged 15.88 10.76 22 640735 5916 62842349
Loose body in joint 15.80 10.76 38 640719 1248 62847017
Blood lactate dehydrogenase increased 15.76 10.76 153 640604 22963 62825302
Abortion incomplete 15.63 10.76 6 640751 3125 62845140
Body height below normal 15.56 10.76 53 640704 2130 62846135
Intervertebral disc degeneration 15.53 10.76 234 640523 15498 62832767
Dysgeusia 15.46 10.76 356 640401 46354 62801911
Feeling abnormal 15.44 10.76 1288 639469 147104 62701161
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.43 10.76 5 640752 2894 62845371
Foetal death 15.33 10.76 174 640583 10806 62837459
Clear cell renal cell carcinoma 15.25 10.76 41 640716 1444 62846821
Gallbladder polyp 15.22 10.76 28 640729 759 62847506
Potentiating drug interaction 15.12 10.76 13 640744 4343 62843922
Rebound effect 15.12 10.76 14 640743 4512 62843753
Colorectal cancer 15.12 10.76 9 640748 3636 62844629
Foetal anticonvulsant syndrome 14.96 10.76 24 640733 581 62847684
Metastases to lymph nodes 14.95 10.76 38 640719 8120 62840145
Presyncope 14.95 10.76 194 640563 27591 62820674
Synovial disorder 14.88 10.76 50 640707 1995 62846270
Klebsiella infection 14.87 10.76 41 640716 8525 62839740
Ataxia 14.87 10.76 91 640666 15104 62833161
Endodontic procedure 14.85 10.76 68 640689 3139 62845126
Lip dry 14.85 10.76 229 640528 15241 62833024
Device breakage 14.77 10.76 63 640694 11479 62836786
Synovial fluid analysis 14.72 10.76 56 640701 2377 62845888
Fear 14.61 10.76 96 640661 15670 62832595
Procedural pain 14.60 10.76 143 640614 21426 62826839
Hypoglycaemic coma 14.50 10.76 4 640753 2571 62845694
Atrioventricular block 14.50 10.76 35 640722 7612 62840653
Acute chest syndrome 14.38 10.76 28 640729 793 62847472
Red blood cell sedimentation rate 14.34 10.76 91 640666 4763 62843502
Neutrophilia 14.29 10.76 14 640743 4392 62843873
Lymphoedema 14.24 10.76 65 640692 11627 62836638
Rectal haemorrhage 14.24 10.76 381 640376 48649 62799616
Body temperature decreased 14.21 10.76 286 640471 20033 62828232
Feeling hot 14.18 10.76 393 640364 49961 62798304
Ileus paralytic 14.15 10.76 15 640742 4536 62843729
Oropharyngeal pain 14.09 10.76 1122 639635 93365 62754900
Injury 14.07 10.76 888 639869 72359 62775906
Oedema peripheral 14.03 10.76 1686 639071 187825 62660440
Incoherent 14.00 10.76 15 640742 4515 62843750
Complication associated with device 13.97 10.76 107 640650 16871 62831394
Skin ulcer 13.94 10.76 549 640208 42496 62805769
Mental disorder 13.94 10.76 181 640576 25738 62822527
Breast cancer female 13.90 10.76 80 640677 13479 62834786
Vaginal flatulence 13.84 10.76 8 640749 3285 62844980
Salivary hypersecretion 13.83 10.76 36 640721 7630 62840635
Congenital arterial malformation 13.76 10.76 17 640740 320 62847945
Hepatitis fulminant 13.75 10.76 9 640748 3455 62844810
Paraesthesia oral 13.74 10.76 126 640631 19130 62829135
Coordination abnormal 13.73 10.76 82 640675 13691 62834574
Amylase increased 13.72 10.76 27 640730 6318 62841947
Maternal exposure timing unspecified 13.62 10.76 120 640637 6967 62841298
Sleep terror 13.61 10.76 5 640752 2675 62845590
Progressive multifocal leukoencephalopathy 13.59 10.76 76 640681 12895 62835370
Skin plaque 13.58 10.76 41 640716 8279 62839986
Retinitis 13.55 10.76 108 640649 6088 62842177
Lupus-like syndrome 13.40 10.76 223 640534 15072 62833193
Joint noise 13.39 10.76 83 640674 4309 62843956
Hyperammonaemia 13.39 10.76 20 640737 5212 62843053
Toxic encephalopathy 13.38 10.76 29 640728 6550 62841715
Breast feeding 13.36 10.76 28 640729 837 62847428
White blood cell count decreased 13.35 10.76 1215 639542 137889 62710376
Low turnover osteopathy 13.34 10.76 80 640677 4105 62844160
Red blood cell count decreased 13.31 10.76 519 640238 40126 62808139
Aplasia 13.28 10.76 14 640743 4245 62844020
Nephropathy toxic 13.23 10.76 50 640707 9429 62838836
Atrial tachycardia 13.15 10.76 14 640743 4226 62844039
Eosinophilic granulomatosis with polyangiitis 13.13 10.76 3 640754 2189 62846076
Dermatitis bullous 13.13 10.76 43 640714 8465 62839800
Foot fracture 13.07 10.76 325 640432 23589 62824676
Hyperreflexia 13.05 10.76 25 640732 5909 62842356
Generalised tonic-clonic seizure 13.02 10.76 210 640547 28806 62819459
Rhinitis allergic 13.00 10.76 178 640579 11549 62836716
Systemic inflammatory response syndrome 12.97 10.76 23 640734 5598 62842667
Pregnancy with contraceptive device 12.95 10.76 17 640740 4677 62843588
Herpes zoster 12.92 10.76 983 639774 81479 62766786
Cyst 12.89 10.76 207 640550 13892 62834373
Visual impairment 12.80 10.76 709 640048 83737 62764528
Tenosynovitis 12.78 10.76 203 640554 13592 62834673
Anti-cyclic citrullinated peptide antibody 12.77 10.76 114 640643 6644 62841621
Renal tubular necrosis 12.77 10.76 69 640688 11809 62836456
Gastrointestinal toxicity 12.74 10.76 38 640719 7703 62840562
Polyhydramnios 12.71 10.76 51 640706 2220 62846045
Crohn's disease 12.65 10.76 89 640668 4824 62843441
Atrial septal defect 12.58 10.76 116 640641 6822 62841443
Cestode infection 12.57 10.76 15 640742 272 62847993
Crying 12.55 10.76 163 640594 23180 62825085
Hepatic necrosis 12.47 10.76 24 640733 5663 62842602
Blood phosphorus decreased 12.42 10.76 16 640741 4437 62843828
Blood iron increased 12.39 10.76 39 640718 1503 62846762
Congenital neuropathy 12.33 10.76 5 640752 11 62848254
Catheter site erythema 12.30 10.76 15 640742 4261 62844004
Bone density increased 12.25 10.76 25 640732 733 62847532
Pharyngitis streptococcal 12.25 10.76 163 640594 10509 62837756
Adjustment disorder with depressed mood 12.19 10.76 157 640600 10047 62838218
Knee operation 12.18 10.76 103 640654 5910 62842355
Pseudomonas infection 12.13 10.76 65 640692 11148 62837117
Chronic sinusitis 12.01 10.76 78 640679 12765 62835500
Venoocclusive disease 11.97 10.76 3 640754 2055 62846210
Rheumatoid lung 11.91 10.76 73 640684 3775 62844490
Proctitis 11.90 10.76 23 640734 5418 62842847
Gonorrhoea 11.89 10.76 10 640747 116 62848149
Glomerular filtration rate decreased 11.88 10.76 83 640674 13358 62834907
Ligament rupture 11.86 10.76 67 640690 3363 62844902
Pruritus genital 11.81 10.76 6 640751 2648 62845617
Laryngeal oedema 11.80 10.76 25 640732 5693 62842572
Device issue 11.73 10.76 169 640588 23612 62824653
Squamous cell carcinoma 11.69 10.76 136 640621 8496 62839769
Human antichimeric antibody positive 11.68 10.76 41 640716 1673 62846592
Implant site pain 11.65 10.76 5 640752 2435 62845830
Sciatica 11.64 10.76 440 640317 33884 62814381
Mood altered 11.63 10.76 94 640663 14649 62833616
Lupus nephritis 11.56 10.76 58 640699 2781 62845484
Muscular weakness 11.55 10.76 1070 639687 121283 62726982
Antibody test positive 11.51 10.76 56 640701 2651 62845614
Blood prolactin increased 11.51 10.76 11 640746 3492 62844773
Wrist fracture 11.50 10.76 197 640560 13390 62834875
Ventricular arrhythmia 11.48 10.76 13 640744 3815 62844450
Persecutory delusion 11.42 10.76 7 640750 2783 62845482
Cell death 11.40 10.76 6 640751 2595 62845670
Hypoalbuminaemia 11.39 10.76 71 640686 11734 62836531
Hypoventilation 11.38 10.76 19 640738 4735 62843530
Stillbirth 11.32 10.76 111 640646 6639 62841626
Cystitis haemorrhagic 11.31 10.76 15 640742 4108 62844157
Drug-induced liver injury 11.31 10.76 314 640443 39908 62808357
Cytomegalovirus infection reactivation 11.30 10.76 14 640743 3949 62844316
Immunosuppressant drug level increased 11.30 10.76 12 640745 3626 62844639
Paraesthesia 11.30 10.76 1399 639358 155567 62692698
Catheter site pain 11.26 10.76 19 640738 4716 62843549
Vascular device infection 11.25 10.76 37 640720 7275 62840990
Cough 11.25 10.76 2701 638056 290042 62558223
Lymph gland infection 11.24 10.76 19 640738 481 62847784
Drug screen positive 11.24 10.76 12 640745 3617 62844648
Skin exfoliation 11.23 10.76 340 640417 42762 62805503
Type I hypersensitivity 11.20 10.76 8 640749 2934 62845331
Gastrointestinal pain 11.09 10.76 149 640608 9627 62838638
Bone lesion 11.09 10.76 27 640730 5854 62842411
Gastrooesophageal reflux disease 11.08 10.76 1115 639642 94524 62753741
Myocardial ischaemia 11.08 10.76 80 640677 12779 62835486
Exomphalos 11.00 10.76 20 640737 537 62847728
Haematocrit decreased 10.99 10.76 494 640263 38846 62809419
Rhinovirus infection 10.94 10.76 18 640739 4511 62843754
Blood pressure inadequately controlled 10.92 10.76 21 640736 4957 62843308
Device deployment issue 10.90 10.76 14 640743 3888 62844377
Hypophosphataemia 10.88 10.76 69 640688 11357 62836908
Product monitoring error 10.86 10.76 18 640739 4498 62843767
Bladder transitional cell carcinoma stage I 10.82 10.76 3 640754 0 62848265
Cerumen removal 10.82 10.76 3 640754 0 62848265
Haematochezia 10.81 10.76 436 640321 53108 62795157

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 448.58 10.28 861 229935 37377 34688758
Toxicity to various agents 426.23 10.28 417 230379 199945 34526190
Drug abuse 367.09 10.28 100 230696 98996 34627139
Completed suicide 352.66 10.28 105 230691 98063 34628072
Drug interaction 273.49 10.28 687 230109 225259 34500876
Arthralgia 210.08 10.28 1874 228922 168167 34557968
Foetal exposure during pregnancy 183.95 10.28 612 230184 37489 34688646
Psoriatic arthropathy 172.69 10.28 395 230401 19403 34706732
Intentional overdose 147.40 10.28 52 230744 43622 34682513
Joint swelling 135.57 10.28 765 230031 59125 34667010
Acute kidney injury 125.62 10.28 1348 229448 303640 34422495
Sickle cell anaemia with crisis 115.16 10.28 138 230658 3915 34722220
Psoriasis 110.85 10.28 529 230267 38283 34687852
Dysmorphism 105.74 10.28 117 230679 3039 34723096
Drug reaction with eosinophilia and systemic symptoms 94.40 10.28 50 230746 32962 34693173
Suicide attempt 94.37 10.28 72 230724 39044 34687091
Coma 92.39 10.28 99 230697 45579 34680556
Rhabdomyolysis 92.09 10.28 195 230601 67968 34658167
Musculoskeletal stiffness 90.70 10.28 573 230223 46107 34680028
Overdose 88.06 10.28 307 230489 90752 34635383
Nasopharyngitis 85.06 10.28 769 230027 69199 34656936
Product use in unapproved indication 84.80 10.28 443 230353 117056 34609079
Febrile neutropenia 80.29 10.28 551 230245 136298 34589837
Hepatic function abnormal 77.22 10.28 108 230688 44255 34681880
Serotonin syndrome 73.95 10.28 20 230776 19913 34706222
Pain 72.81 10.28 1817 228979 202858 34523277
Blood pressure fluctuation 71.25 10.28 343 230453 24906 34701229
Fatigue 65.43 10.28 3031 227765 367622 34358513
Coombs positive haemolytic anaemia 65.32 10.28 53 230743 919 34725216
Enthesopathy 64.32 10.28 112 230684 4501 34721634
Cytomegalovirus infection 63.17 10.28 48 230748 26087 34700048
Premature baby 61.51 10.28 275 230521 19358 34706777
Arthropathy 61.04 10.28 344 230452 26563 34699572
Tenosynovitis 59.91 10.28 108 230688 4462 34721673
Exposure during pregnancy 59.67 10.28 161 230635 8773 34717362
Speech disorder developmental 59.40 10.28 73 230723 2127 34724008
Cardiac failure 57.73 10.28 359 230437 90889 34635246
Arthritis 56.12 10.28 377 230419 30969 34695166
Drug resistance 54.91 10.28 54 230742 25873 34700262
Renal failure 54.77 10.28 574 230222 129983 34596152
Death 54.05 10.28 2116 228680 395933 34330202
Peripheral swelling 54.00 10.28 756 230040 75785 34650350
Angioedema 53.81 10.28 103 230693 37271 34688864
Depressed level of consciousness 52.62 10.28 129 230667 42712 34683423
Synovitis 52.62 10.28 208 230588 13858 34712277
Renal impairment 50.82 10.28 390 230406 94123 34632012
Foetal anticonvulsant syndrome 50.50 10.28 50 230746 1137 34724998
Blood pressure systolic abnormal 50.10 10.28 92 230704 3856 34722279
Juvenile idiopathic arthritis 49.70 10.28 62 230734 1835 34724300
Haemoglobin decreased 49.25 10.28 1093 229703 119679 34606456
Neonatal respiratory distress syndrome 48.69 10.28 92 230704 3942 34722193
Infusion related reaction 48.51 10.28 550 230246 52507 34673628
C-reactive protein abnormal 48.49 10.28 147 230649 8563 34717572
Respiratory arrest 48.07 10.28 69 230727 27974 34698161
Pain in extremity 47.88 10.28 1133 229663 125380 34600755
Blood pressure systolic increased 47.87 10.28 287 230509 22665 34703470
Poisoning 47.81 10.28 11 230785 12215 34713920
Sedation 47.74 10.28 41 230755 20965 34705170
Bradycardia 47.55 10.28 297 230499 75121 34651014
Grip strength decreased 46.89 10.28 79 230717 3090 34723045
Altered state of consciousness 44.76 10.28 51 230745 22842 34703293
Alanine aminotransferase abnormal 43.63 10.28 96 230700 4592 34721543
Psychotic disorder 43.07 10.28 59 230737 24393 34701742
Blood pressure diastolic abnormal 42.97 10.28 97 230699 4721 34721414
Maternal exposure during pregnancy 42.74 10.28 98 230698 4820 34721315
Haemolysis 42.64 10.28 134 230662 7960 34718175
Hypospadias 42.41 10.28 76 230720 3125 34723010
Delirium 42.03 10.28 149 230647 43842 34682293
Lactic acidosis 41.69 10.28 106 230690 34666 34691469
Toxic epidermal necrolysis 41.48 10.28 49 230747 21597 34704538
Weight decreased 41.15 10.28 1486 229310 174815 34551320
Learning disorder 41.03 10.28 43 230753 1048 34725087
Immune reconstitution inflammatory syndrome 40.60 10.28 5 230791 8754 34717381
Autism spectrum disorder 40.49 10.28 62 230734 2234 34723901
Lymphadenitis 40.42 10.28 58 230738 1970 34724165
Hypoglycaemia neonatal 40.31 10.28 56 230740 1845 34724290
Cryptorchism 40.14 10.28 58 230738 1983 34724152
Atrial septal defect 39.51 10.28 123 230673 7269 34718866
Disease progression 39.50 10.28 490 230306 107587 34618548
Osteoarthritis 39.21 10.28 252 230544 20390 34705745
Suicidal ideation 39.12 10.28 136 230660 40252 34685883
Foot deformity 38.97 10.28 90 230706 4447 34721688
Low birth weight baby 38.14 10.28 127 230669 7778 34718357
Blood pressure increased 38.03 10.28 804 229992 87298 34638837
Maternal drugs affecting foetus 37.81 10.28 82 230714 3883 34722252
Cholestasis 37.30 10.28 76 230720 26872 34699263
Neuroleptic malignant syndrome 37.23 10.28 38 230758 17896 34708239
Maternal exposure during breast feeding 36.64 10.28 48 230748 1493 34724642
Intentional self-injury 36.32 10.28 23 230773 13748 34712387
Rheumatoid nodule 35.31 10.28 67 230729 2880 34723255
Acute hepatic failure 35.11 10.28 25 230771 14049 34712086
Sinusitis 34.65 10.28 422 230374 40980 34685155
Shock 34.49 10.28 67 230729 24112 34702023
Substance abuse 33.90 10.28 5 230791 7636 34718499
Small for dates baby 33.84 10.28 78 230718 3849 34722286
Syndactyly 33.73 10.28 35 230761 843 34725292
Cardiac arrest 33.63 10.28 440 230356 95719 34630416
Basal cell carcinoma 33.15 10.28 233 230563 19425 34706710
Agranulocytosis 33.12 10.28 67 230729 23754 34702381
Therapeutic product effect decreased 32.58 10.28 362 230434 34381 34691754
Agitation 32.19 10.28 234 230562 57165 34668970
Ventricular septal defect 31.80 10.28 77 230719 3924 34722211
Rash maculo-papular 31.64 10.28 90 230706 28361 34697774
Tongue disorder 31.52 10.28 92 230704 5247 34720888
Neurotoxicity 30.19 10.28 45 230751 17965 34708170
Joint effusion 30.19 10.28 89 230707 5104 34721031
Blood pressure diastolic increased 30.06 10.28 87 230709 4938 34721197
Hand deformity 29.94 10.28 72 230724 3653 34722482
Electrocardiogram QT prolonged 29.17 10.28 155 230641 40797 34685338
Hypoglycaemia 29.10 10.28 226 230570 54414 34671721
Joint laxity 28.82 10.28 23 230773 389 34725746
Victim of child abuse 28.72 10.28 33 230763 894 34725241
Blood creatine phosphokinase increased 28.60 10.28 176 230620 44681 34681454
Developmental delay 28.32 10.28 59 230737 2716 34723419
Oropharyngeal pain 28.11 10.28 358 230438 35127 34691008
Heart rate decreased 28.07 10.28 327 230469 31418 34694717
Cardio-respiratory arrest 27.88 10.28 232 230564 55041 34671094
Knee arthroplasty 27.78 10.28 110 230686 7334 34718801
Venoocclusive liver disease 27.71 10.28 9 230787 7957 34718178
Hepatic enzyme increased 27.54 10.28 386 230410 38694 34687441
Influenza 27.51 10.28 471 230325 49195 34676940
Wound 27.34 10.28 180 230616 14684 34711451
Talipes 27.21 10.28 47 230749 1876 34724259
Palmar-plantar erythrodysaesthesia syndrome 27.16 10.28 43 230753 16752 34709383
Cellulitis 27.14 10.28 496 230300 52455 34673680
Metabolic acidosis 27.01 10.28 173 230623 43507 34682628
Akathisia 26.76 10.28 10 230786 8099 34718036
Crystal nephropathy 26.74 10.28 23 230773 434 34725701
Aspergillus infection 26.55 10.28 25 230771 12229 34713906
Localised infection 26.53 10.28 203 230593 17384 34708751
Hepatocellular injury 26.40 10.28 68 230728 22143 34703992
Mucormycosis 26.10 10.28 4 230792 5938 34720197
Blood pressure diastolic decreased 25.98 10.28 124 230672 8970 34717165
Astigmatism 25.82 10.28 34 230762 1063 34725072
Exposure via breast milk 25.71 10.28 47 230749 1963 34724172
Tendonitis 25.66 10.28 124 230672 9016 34717119
Muscle swelling 25.65 10.28 21 230775 369 34725766
Tachycardia 25.38 10.28 400 230396 84372 34641763
Pulmonary fibrosis 25.37 10.28 208 230588 18188 34707947
Interstitial lung disease 25.35 10.28 292 230504 64990 34661145
Congenital hand malformation 25.20 10.28 25 230771 570 34725565
Plagiocephaly 25.03 10.28 24 230772 524 34725611
Intellectual disability 24.83 10.28 37 230759 1301 34724834
Hypermobility syndrome 24.73 10.28 20 230776 345 34725790
Colitis ulcerative 24.54 10.28 190 230606 16330 34709805
Drug level increased 24.49 10.28 70 230726 22026 34704109
Sleep disorder due to a general medical condition 24.15 10.28 3 230793 5218 34720917
Finger deformity 24.11 10.28 39 230757 1474 34724661
Malignant neoplasm progression 23.89 10.28 423 230373 87623 34638512
Hepatic failure 23.87 10.28 132 230664 34399 34691736
Aggression 23.75 10.28 155 230641 38809 34687326
Lower respiratory tract infection 23.73 10.28 316 230480 31321 34694814
Haematocrit decreased 23.43 10.28 320 230476 31896 34694239
Vitamin D deficiency 23.34 10.28 96 230700 6512 34719623
Hyperglycaemia 23.09 10.28 159 230637 39321 34686814
Full blood count decreased 23.09 10.28 201 230595 17887 34708248
Musculoskeletal pain 23.04 10.28 317 230479 31646 34694489
Eosinophilia 22.98 10.28 92 230704 26130 34700005
Anaphylactic shock 22.88 10.28 44 230752 15897 34710238
Drug intolerance 22.65 10.28 534 230262 59036 34667099
Dysgraphia 22.62 10.28 48 230748 2239 34723896
Post procedural infection 22.53 10.28 77 230719 4779 34721356
Pyrexia 22.36 10.28 1894 228902 331119 34395016
Abdominal discomfort 22.33 10.28 535 230261 59300 34666835
Appendicolith 22.24 10.28 114 230682 8487 34717648
Pathogen resistance 22.17 10.28 18 230778 9464 34716671
Caesarean section 22.08 10.28 46 230750 2118 34724017
Jaundice neonatal 21.87 10.28 35 230761 1311 34724824
Acute chest syndrome 21.62 10.28 27 230769 800 34725335
Acute graft versus host disease 21.50 10.28 8 230788 6495 34719640
Suspected suicide 21.31 10.28 3 230793 4745 34721390
Off label use 21.22 10.28 2436 228360 417088 34309047
Multiple organ dysfunction syndrome 21.04 10.28 367 230429 76199 34649936
Intentional product misuse 20.99 10.28 196 230600 45415 34680720
Large for dates baby 20.91 10.28 28 230768 890 34725245
Language disorder 20.77 10.28 46 230750 2210 34723925
Back disorder 20.71 10.28 93 230703 6558 34719577
Stevens-Johnson syndrome 20.70 10.28 59 230737 18580 34707555
Foetal growth restriction 20.63 10.28 67 230729 4050 34722085
Somnolence 20.60 10.28 567 230229 110549 34615586
Diaphragmatic disorder 20.50 10.28 33 230763 1242 34724893
Hypokalaemia 20.48 10.28 266 230530 57948 34668187
Nephrolithiasis 20.33 10.28 297 230499 30036 34696099
Inflammation 20.14 10.28 280 230516 28015 34698120
Disseminated intravascular coagulation 20.10 10.28 75 230721 21741 34704394
Red blood cell sedimentation rate increased 20.03 10.28 116 230680 9046 34717089
Skin cancer 19.74 10.28 126 230670 10171 34715964
Posterior reversible encephalopathy syndrome 19.65 10.28 22 230774 9932 34716203
Ear infection 19.49 10.28 125 230671 10106 34716029
Polyarthritis 19.35 10.28 70 230726 4470 34721665
Ultrasound antenatal screen 19.30 10.28 21 230775 535 34725600
Myoclonus 19.15 10.28 43 230753 14682 34711453
Hydrops foetalis 19.07 10.28 26 230770 841 34725294
Joint range of motion decreased 18.97 10.28 97 230699 7215 34718920
Bronchopulmonary aspergillosis 18.91 10.28 43 230753 14616 34711519
Osteonecrosis of jaw 18.87 10.28 58 230738 17831 34708304
Anal fistula 18.73 10.28 78 230718 5321 34720814
Cardiotoxicity 18.58 10.28 7 230789 5641 34720494
Ear disorder 18.51 10.28 37 230759 1653 34724482
Upper respiratory tract infection 18.48 10.28 314 230482 32745 34693390
Otitis media 18.42 10.28 51 230745 2821 34723314
Second primary malignancy 18.40 10.28 15 230781 7871 34718264
Drug withdrawal syndrome 18.40 10.28 68 230728 19766 34706369
Red blood cell count decreased 18.39 10.28 282 230514 28808 34697327
Selective eating disorder 18.38 10.28 38 230758 1740 34724395
Thrombotic microangiopathy 18.37 10.28 26 230770 10604 34715531
Scoliosis 18.32 10.28 50 230746 2743 34723392
Body temperature decreased 18.31 10.28 148 230648 12886 34713249
Acute generalised exanthematous pustulosis 18.31 10.28 11 230785 6765 34719370
Poor venous access 18.08 10.28 75 230721 5108 34721027
Malignant melanoma 18.06 10.28 103 230693 7987 34718148
Hyperbilirubinaemia neonatal 18.04 10.28 24 230772 758 34725377
Hyperkalaemia 17.99 10.28 336 230460 69053 34657082
Lung hernia 17.94 10.28 9 230787 63 34726072
Epidural lipomatosis 17.94 10.28 28 230768 1026 34725109
Hypotonia neonatal 17.90 10.28 32 230764 1313 34724822
Proteinuria 17.90 10.28 63 230733 18579 34707556
Encephalitis toxic 17.88 10.28 15 230781 273 34725862
Dyspraxia 17.84 10.28 18 230778 419 34725716
Motor developmental delay 17.77 10.28 22 230774 646 34725489
Knee deformity 17.77 10.28 22 230774 646 34725489
Progressive multifocal leukoencephalopathy 17.76 10.28 23 230773 9741 34716394
Hyperammonaemia 17.68 10.28 10 230786 6357 34719778
Cytomegalovirus viraemia 17.50 10.28 14 230782 7416 34718719
Abdominal distension 17.49 10.28 508 230288 57984 34668151
Drug ineffective 17.45 10.28 2699 228097 454052 34272083
Cerebral haemorrhage 17.45 10.28 147 230649 34790 34691345
Gamma-glutamyltransferase increased 17.45 10.28 117 230679 29114 34697021
Respiratory failure 17.40 10.28 565 230231 108007 34618128
Fall 17.33 10.28 1560 229236 201325 34524810
Wrong technique in product usage process 17.27 10.28 153 230643 35833 34690302
Immunodeficiency 17.21 10.28 77 230719 5421 34720714
Cystitis haemorrhagic 17.14 10.28 8 230788 5671 34720464
Contusion 17.04 10.28 336 230460 36028 34690107
Trisomy 18 16.78 10.28 23 230773 748 34725387
Radiation inflammation 16.76 10.28 25 230771 880 34725255
Strabismus 16.74 10.28 36 230760 1695 34724440
Mass 16.58 10.28 99 230697 7806 34718329
Kidney infection 16.48 10.28 75 230721 5319 34720816
Cerebral infarction 16.33 10.28 110 230686 27345 34698790
Thrombocytopenia 16.32 10.28 854 229942 155393 34570742
Nasal disorder 16.29 10.28 38 230758 1890 34724245
Electrocardiogram QRS complex prolonged 16.21 10.28 6 230790 4888 34721247
Acute graft versus host disease in skin 16.21 10.28 7 230789 5194 34720941
Haematochezia 16.15 10.28 412 230384 46122 34680013
Transplant rejection 16.11 10.28 27 230769 10284 34715851
Haemophagocytic lymphohistiocytosis 15.97 10.28 39 230757 12934 34713201
Dyslexia 15.96 10.28 15 230781 319 34725816
BK virus infection 15.95 10.28 9 230787 5729 34720406
Congenital foot malformation 15.88 10.28 17 230779 425 34725710
Crohn's disease 15.87 10.28 51 230745 3066 34723069
Tuberculosis 15.85 10.28 104 230692 8473 34717662
Limb reduction defect 15.73 10.28 14 230782 277 34725858
Ankylosing spondylitis 15.71 10.28 76 230720 5528 34720607
Multiple congenital abnormalities 15.69 10.28 19 230777 545 34725590
Abdominal pain 15.68 10.28 1269 229527 162349 34563786
Arthritis infective 15.68 10.28 54 230742 3365 34722770
Serum ferritin increased 15.57 10.28 81 230715 6065 34720070
Joint stiffness 15.57 10.28 124 230672 10749 34715386
Foetal disorder 15.56 10.28 23 230773 803 34725332
Hypotension 15.54 10.28 1256 229540 220393 34505742
Loss of consciousness 15.53 10.28 421 230375 82246 34643889
Cytokine release syndrome 15.51 10.28 88 230708 22789 34703346
Synovial cyst 15.41 10.28 42 230754 2302 34723833
Urinary tract infection 15.24 10.28 690 230106 83391 34642744
Haemorrhage intracranial 15.23 10.28 54 230742 15892 34710243
Haematotoxicity 15.22 10.28 19 230777 8175 34717960
Hepatic encephalopathy 15.21 10.28 48 230748 14637 34711498
Cleft lip and palate 15.21 10.28 24 230772 888 34725247
Spinal disorder 15.20 10.28 62 230734 4190 34721945
Chronic graft versus host disease 15.11 10.28 5 230791 4368 34721767
Graft versus host disease in gastrointestinal tract 15.04 10.28 3 230793 3680 34722455
Stiff person syndrome 15.01 10.28 9 230787 93 34726042
Adenovirus infection 14.97 10.28 8 230788 5249 34720886
Drug withdrawal syndrome neonatal 14.75 10.28 55 230741 3564 34722571
Asphyxia 14.74 10.28 14 230782 6821 34719314
Diabetic ketoacidosis 14.72 10.28 65 230731 17967 34708168
Product dose omission issue 14.64 10.28 947 229849 118764 34607371
Back pain 14.64 10.28 962 229834 120827 34605308
Hypocalcaemia 14.61 10.28 97 230699 24192 34701943
Hallucination, visual 14.61 10.28 64 230732 17727 34708408
Ventricular tachycardia 14.59 10.28 109 230687 26470 34699665
Headache 14.53 10.28 1525 229271 199110 34527025
Pulmonary alveolar haemorrhage 14.40 10.28 17 230779 7495 34718640
C-reactive protein increased 14.35 10.28 463 230333 53635 34672500
Pancytopenia 14.35 10.28 767 230029 94390 34631745
Hydrocele 14.33 10.28 38 230758 2049 34724086
Therapy partial responder 14.28 10.28 26 230770 9590 34716545
Red blood cell sedimentation rate 14.22 10.28 27 230769 1161 34724974
Tubulointerstitial nephritis 14.19 10.28 81 230715 20943 34705192
Product quality issue 14.16 10.28 61 230735 16974 34709161
Arthritis bacterial 14.14 10.28 69 230727 5037 34721098
Extrapyramidal disorder 14.13 10.28 41 230755 12839 34713296
Medical device implantation 14.12 10.28 19 230777 607 34725528
Hepatitis fulminant 14.11 10.28 5 230791 4185 34721950
Congenital bladder anomaly 14.09 10.28 13 230783 270 34725865
Acute respiratory distress syndrome 14.01 10.28 107 230689 25862 34700273
Lacrimal disorder 14.01 10.28 14 230782 322 34725813
Cleft lip 13.98 10.28 14 230782 323 34725812
Pneumonia 13.97 10.28 2656 228140 359971 34366164
Status epilepticus 13.95 10.28 40 230756 12574 34713561
Hypertransaminasaemia 13.93 10.28 10 230786 5596 34720539
Skin lesion 13.92 10.28 213 230583 21748 34704387
Colorectal cancer 13.92 10.28 7 230789 4754 34721381
Weight decrease neonatal 13.91 10.28 14 230782 325 34725810
Dystonia 13.83 10.28 32 230764 10813 34715322
Catatonia 13.80 10.28 8 230788 5017 34721118
Pectus excavatum 13.79 10.28 12 230784 230 34725905
Hallucination, auditory 13.77 10.28 37 230759 11880 34714255
Spinal stenosis 13.74 10.28 70 230726 5199 34720936
Gastrointestinal infection 13.73 10.28 75 230721 5723 34720412
Obsessive-compulsive disorder 13.73 10.28 10 230786 5554 34720581
Hyperthermia 13.66 10.28 31 230765 10546 34715589
Hypertelorism 13.64 10.28 18 230778 564 34725571
Respiratory disorder neonatal 13.63 10.28 32 230764 1598 34724537
Ischaemic stroke 13.60 10.28 68 230728 18182 34707953
Arthrodesis 13.57 10.28 16 230780 446 34725689
Ankyloglossia congenital 13.55 10.28 13 230783 284 34725851
Nerve compression 13.50 10.28 50 230746 3229 34722906
Blood parathyroid hormone decreased 13.42 10.28 30 230766 1450 34724685
Cataract 13.31 10.28 245 230551 25941 34700194
Appendicitis 13.30 10.28 153 230643 14654 34711481
Fistula discharge 13.27 10.28 22 230774 849 34725286
Agitation neonatal 13.23 10.28 25 230771 1071 34725064
Nephropathy toxic 13.14 10.28 41 230755 12547 34713588
Attention deficit hyperactivity disorder 13.14 10.28 42 230754 2517 34723618
Hepatitis 13.13 10.28 98 230698 23806 34702329
Hypoaesthesia 13.11 10.28 513 230283 60931 34665204
Miosis 13.10 10.28 27 230769 9508 34716627
Exposure to toxic agent 13.05 10.28 4 230792 3671 34722464
Microcephaly 13.05 10.28 21 230775 790 34725345
Personality change 12.99 10.28 9 230787 5130 34721005
Drug dependence 12.97 10.28 100 230696 24117 34702018
Skin abrasion 12.96 10.28 86 230710 7033 34719102
Cardiac failure chronic 12.90 10.28 20 230776 7859 34718276
Granuloma skin 12.83 10.28 27 230769 1252 34724883
Nocardiosis 12.83 10.28 5 230791 3946 34722189
Neck mass 12.77 10.28 31 230765 1582 34724553
Bronchitis 12.70 10.28 365 230431 41598 34684537
Anal fissure 12.62 10.28 59 230737 4231 34721904
Renal aplasia 12.56 10.28 20 230776 746 34725389
Pleural fibrosis 12.55 10.28 28 230768 1352 34724783
Nephrotic syndrome 12.48 10.28 18 230778 7285 34718850
Tumour lysis syndrome 12.46 10.28 64 230732 16995 34709140
Pneumonia aspiration 12.44 10.28 198 230598 41705 34684430
Disinhibition 12.42 10.28 3 230793 3223 34722912
Congenital anomaly 12.37 10.28 28 230768 1365 34724770
Mobility decreased 12.36 10.28 273 230523 29855 34696280
Dysstasia 12.33 10.28 129 230667 12066 34714069
Heart rate irregular 12.31 10.28 159 230637 15648 34710487
Joint ankylosis 12.22 10.28 30 230766 1542 34724593
Potentiating drug interaction 12.21 10.28 9 230787 4968 34721167
Oesophageal fibrosis 12.20 10.28 10 230786 176 34725959
Septic arthritis staphylococcal 12.16 10.28 16 230780 500 34725635
Haemangioma congenital 12.11 10.28 16 230780 502 34725633
Leukopenia 12.09 10.28 319 230477 62537 34663598
Cystatin C increased 12.08 10.28 3 230793 0 34726135
Hepatitis B 12.06 10.28 13 230783 5970 34720165
Osteomyelitis 12.02 10.28 161 230635 15975 34710160
Abortion spontaneous 11.99 10.28 14 230782 386 34725749
Tooth malformation 11.97 10.28 10 230786 181 34725954
Toxic skin eruption 11.95 10.28 37 230759 11348 34714787
Abdominal adhesions 11.90 10.28 29 230767 1484 34724651
Bone cyst 11.88 10.28 30 230766 1570 34724565
Muscle twitching 11.88 10.28 32 230764 10266 34715869
Hernia pain 11.84 10.28 12 230784 281 34725854
Iron deficiency 11.68 10.28 68 230728 5313 34720822
Arnold-Chiari malformation 11.65 10.28 13 230783 341 34725794
Hepatitis E virus test positive 11.63 10.28 12 230784 287 34725848
Abnormal behaviour 11.61 10.28 107 230689 24862 34701273
Blood phosphorus increased 11.58 10.28 89 230707 7632 34718503
Diverticulum 11.57 10.28 84 230712 7075 34719060
Chronic obstructive pulmonary disease 11.54 10.28 413 230383 48505 34677630
Developmental coordination disorder 11.52 10.28 10 230786 191 34725944
Labelled drug-drug interaction medication error 11.51 10.28 55 230741 14884 34711251
Restlessness 11.51 10.28 110 230686 25372 34700763
Fistula 11.49 10.28 81 230715 6759 34719376
Congestive cardiomyopathy 11.43 10.28 20 230776 7490 34718645
Dry throat 11.42 10.28 39 230757 2420 34723715
Flatulence 11.36 10.28 200 230596 20998 34705137
Sexual dysfunction 11.31 10.28 15 230781 6288 34719847
Behaviour disorder 11.28 10.28 63 230733 4847 34721288
Autoscopy 11.26 10.28 11 230785 246 34725889
Glycosylated haemoglobin increased 11.17 10.28 38 230758 11322 34714813
Pharyngeal disorder 11.15 10.28 19 230777 750 34725385
Lung neoplasm malignant 11.14 10.28 169 230627 17226 34708909
Pancreatitis 11.13 10.28 185 230611 38706 34687429
Nasal congestion 11.12 10.28 214 230582 22843 34703292
Vomiting 11.07 10.28 1449 229347 246172 34479963
Lipase increased 11.06 10.28 29 230767 9387 34716748
Nodule 11.02 10.28 80 230716 6739 34719396
Gastric haemorrhage 11.01 10.28 33 230763 10228 34715907
Stress 10.91 10.28 270 230526 30077 34696058
Therapeutic response shortened 10.91 10.28 85 230711 7319 34718816
Hepatitis E antibody positive 10.90 10.28 11 230785 256 34725879
Infection 10.89 10.28 718 230078 90197 34635938
Drug ineffective for unapproved indication 10.87 10.28 102 230694 23613 34702522
Inguinal hernia 10.86 10.28 87 230709 7554 34718581
Maternal exposure timing unspecified 10.81 10.28 13 230783 370 34725765
Psychiatric decompensation 10.79 10.28 3 230793 2934 34723201
Vascular stent thrombosis 10.78 10.28 3 230793 2932 34723203
Hyperbilirubinaemia 10.78 10.28 66 230730 16777 34709358
Umbilical hernia 10.74 10.28 60 230736 4617 34721518
Neutrophil count decreased 10.74 10.28 256 230540 50848 34675287
Neutropenia 10.73 10.28 890 229906 155888 34570247
Skin injury 10.72 10.28 37 230759 2308 34723827
Hypertriglyceridaemia 10.72 10.28 25 230771 8423 34717712
Hypermetropia 10.69 10.28 15 230781 499 34725636
Asthenia 10.68 10.28 1808 228988 243443 34482692
Erythema multiforme 10.65 10.28 26 230770 8623 34717512
Renal injury 10.63 10.28 38 230758 11157 34714978
Latent tuberculosis 10.59 10.28 26 230770 1337 34724798
Myelosuppression 10.57 10.28 79 230717 19186 34706949
Cough 10.55 10.28 1139 229657 149001 34577134
Haemangioma 10.54 10.28 32 230764 1865 34724270
Foetal heart rate deceleration abnormality 10.53 10.28 15 230781 506 34725629
Endophthalmitis 10.50 10.28 5 230791 3503 34722632
Forced expiratory volume decreased 10.49 10.28 4 230792 3199 34722936
Pancreatitis acute 10.49 10.28 127 230669 28014 34698121
Complications of transplanted kidney 10.47 10.28 9 230787 4600 34721535
C-reactive protein decreased 10.41 10.28 33 230763 1969 34724166
Accidental overdose 10.39 10.28 84 230712 20056 34706079
Mean cell volume increased 10.39 10.28 45 230751 3124 34723011
Bronchiolitis 10.33 10.28 45 230751 3131 34723004
Joint instability 10.29 10.28 14 230782 452 34725683

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1428.78 10.09 181 663724 245586 78834897
Toxicity to various agents 1242.50 10.09 1013 662892 420527 78659956
Rheumatoid arthritis 1070.04 10.09 3989 659916 204481 78876002
Joint swelling 842.41 10.09 4674 659231 283972 78796511
Drug abuse 826.51 10.09 173 663732 162518 78917965
Arthropathy 763.98 10.09 3210 660695 173901 78906582
Drug interaction 735.26 10.09 1467 662438 413716 78666767
Pemphigus 693.23 10.09 2112 661793 97470 78983013
Systemic lupus erythematosus 681.94 10.09 2390 661515 118759 78961724
Hand deformity 670.82 10.09 2147 661758 101772 78978711
Pain 663.99 10.09 8846 655059 694956 78385527
Synovitis 625.18 10.09 2700 661205 148034 78932449
Glossodynia 608.00 10.09 2069 661836 101268 78979215
Arthralgia 580.71 10.09 7287 656618 564516 78515967
Intentional overdose 505.58 10.09 129 663776 105831 78974652
Anti-cyclic citrullinated peptide antibody positive 505.22 10.09 1683 662222 81460 78999023
Infusion related reaction 497.96 10.09 3453 660452 226784 78853699
Wound 497.00 10.09 2101 661804 114078 78966405
Abdominal discomfort 478.33 10.09 3649 660256 247078 78833405
Maternal exposure during pregnancy 447.43 10.09 2284 661621 134254 78946229
Pericarditis 446.59 10.09 1886 662019 102350 78978133
Acute kidney injury 423.52 10.09 2562 661343 516842 78563641
Alopecia 413.00 10.09 3316 660589 228039 78852444
Nasopharyngitis 395.63 10.09 3530 660375 250351 78830132
Swelling 386.17 10.09 3105 660800 213606 78866877
Discomfort 376.99 10.09 2051 661854 123566 78956917
Death 373.76 10.09 2973 660932 563541 78516942
Therapeutic product effect decreased 369.79 10.09 2484 661421 161379 78919104
Contraindicated product administered 357.21 10.09 2391 661514 155147 78925336
Hepatic enzyme increased 356.09 10.09 2672 661233 179938 78900545
Febrile neutropenia 356.00 10.09 880 663025 230119 78850364
Sinusitis 338.99 10.09 2784 661121 192717 78887766
Psoriatic arthropathy 320.70 10.09 1394 662511 76605 79003878
Suicide attempt 316.27 10.09 147 663758 82785 78997698
Musculoskeletal stiffness 315.76 10.09 2515 661390 172493 78907990
Helicobacter infection 313.22 10.09 1280 662625 68424 79012059
Duodenal ulcer perforation 307.19 10.09 1228 662677 64983 79015500
Rheumatoid factor positive 293.96 10.09 1130 662775 58709 79021774
Cardiac arrest 290.59 10.09 624 663281 171472 78909011
Peripheral swelling 272.19 10.09 3435 660470 266182 78814301
Overdose 268.18 10.09 722 663183 183484 78896999
Drug reaction with eosinophilia and systemic symptoms 262.33 10.09 103 663802 64141 79016342
Rhabdomyolysis 256.26 10.09 288 663617 102843 78977640
Lower respiratory tract infection 247.95 10.09 1884 662021 127336 78953147
Drug intolerance 243.18 10.09 3309 660596 260810 78819673
Impaired healing 234.43 10.09 1388 662517 86267 78994216
Exposure during pregnancy 230.97 10.09 1538 662367 99594 78980889
Fatigue 230.31 10.09 9691 654214 920036 78160447
Hypersensitivity 228.69 10.09 3254 660651 258985 78821498
Cardiac failure 218.57 10.09 616 663289 154226 78926257
Lactic acidosis 204.35 10.09 171 663734 70188 79010295
Sopor 202.46 10.09 20 663885 32990 79047493
Renal failure 202.14 10.09 922 662983 200046 78880437
Respiratory arrest 195.88 10.09 118 663787 57432 79023051
Hepatic function abnormal 194.11 10.09 193 663712 72914 79007569
Bradycardia 193.74 10.09 536 663369 135021 78945462
Arthritis 187.83 10.09 1615 662290 113265 78967218
Irritable bowel syndrome 180.42 10.09 1007 662898 61234 79019249
Muscle injury 180.17 10.09 842 663063 47719 79032764
Weight increased 179.18 10.09 3275 660630 274111 78806372
Neutropenia 179.16 10.09 1532 662373 286178 78794305
Depressed level of consciousness 177.15 10.09 334 663571 96318 78984165
C-reactive protein abnormal 176.05 10.09 834 663071 47533 79032950
Malignant neoplasm progression 174.70 10.09 565 663340 135425 78945058
Folliculitis 173.35 10.09 915 662990 54465 79026018
Serotonin syndrome 172.92 10.09 79 663826 44948 79035535
Sickle cell anaemia with crisis 172.33 10.09 267 663638 7655 79072828
Cardio-respiratory arrest 172.06 10.09 407 663498 108103 78972380
Renal impairment 171.39 10.09 703 663202 157080 78923403
Coma 169.78 10.09 365 663540 100284 78980199
Blister 166.12 10.09 1622 662283 117854 78962629
Cytomegalovirus infection 165.05 10.09 74 663831 42570 79037913
Sleep disorder due to general medical condition, insomnia type 163.63 10.09 758 663147 42798 79037685
Knee arthroplasty 160.53 10.09 750 663155 42498 79037985
Osteoarthritis 157.48 10.09 1255 662650 86054 78994429
Electrocardiogram QT prolonged 157.31 10.09 322 663583 90064 78990419
Red blood cell sedimentation rate abnormal 156.54 10.09 456 663449 20507 79059976
Blood pressure fluctuation 155.01 10.09 1024 662881 66121 79014362
Fibromyalgia 153.27 10.09 989 662916 63351 79017132
Product use issue 150.74 10.09 2520 661385 207302 78873181
Contusion 148.46 10.09 1892 662013 146884 78933599
Hypoglycaemia 145.68 10.09 401 663504 101193 78979290
Disease progression 144.80 10.09 919 662986 183443 78897040
Psoriasis 144.63 10.09 1256 662649 88331 78992152
Immunodeficiency 144.21 10.09 454 663451 21314 79059169
Hip arthroplasty 143.84 10.09 635 663270 35121 79045362
Drug resistance 134.85 10.09 93 663812 42120 79038363
Poisoning 134.32 10.09 24 663881 25248 79055235
Intentional self-injury 133.96 10.09 51 663854 32368 79048115
Metabolic acidosis 132.87 10.09 307 663598 82222 78998261
Agitation 132.48 10.09 408 663497 99307 78981176
Treatment failure 132.29 10.09 2074 661831 168412 78912071
Hyponatraemia 129.88 10.09 906 662999 176942 78903541
Tachycardia 129.62 10.09 906 662999 176862 78903621
Hepatic failure 124.50 10.09 198 663707 61014 79019469
Thrombocytopenia 123.59 10.09 1513 662392 263746 78816737
Altered state of consciousness 123.00 10.09 110 663795 43712 79036771
Cholestasis 120.39 10.09 154 663751 51955 79028528
Angioedema 119.88 10.09 286 663619 75749 79004734
Hypotension 119.42 10.09 2773 661132 437544 78642939
Multiple organ dysfunction syndrome 117.68 10.09 557 663348 119689 78960794
Respiratory failure 115.83 10.09 956 662949 179955 78900528
Bursitis 114.77 10.09 596 663309 35248 79045235
Blood pressure systolic abnormal 114.52 10.09 360 663545 16887 79063596
Rash 114.04 10.09 5896 658009 572462 78508021
Pain in extremity 112.56 10.09 3896 660009 360642 78719841
Product use in unapproved indication 112.50 10.09 1439 662466 248920 78831563
Blood pressure diastolic abnormal 112.41 10.09 384 663521 18818 79061665
Ill-defined disorder 112.35 10.09 935 662970 64940 79015543
Abortion spontaneous 111.93 10.09 515 663390 28992 79051491
Hepatocellular injury 111.68 10.09 139 663766 47454 79033029
Pregnancy 111.16 10.09 481 663424 26370 79054113
Rheumatic fever 109.79 10.09 500 663405 28025 79052458
Hyperkalaemia 109.57 10.09 534 663371 113864 78966619
Disseminated intravascular coagulation 105.44 10.09 86 663819 35756 79044727
Grip strength decreased 101.71 10.09 406 663499 21463 79059020
Blood pressure systolic increased 98.32 10.09 920 662985 66066 79014417
Somnolence 98.17 10.09 1399 662506 237582 78842901
Leukopenia 97.62 10.09 569 663336 115944 78964539
Juvenile idiopathic arthritis 97.33 10.09 156 663749 4607 79075876
Shock 97.23 10.09 132 663773 43416 79037067
Hyperglycaemia 95.41 10.09 285 663620 70050 79010433
Neuroleptic malignant syndrome 93.09 10.09 57 663848 27502 79052981
Swollen joint count increased 92.85 10.09 408 663497 22519 79057964
Infection 91.53 10.09 2648 661257 239064 78841419
Joint effusion 89.93 10.09 342 663563 17672 79062811
Acute hepatic failure 88.90 10.09 72 663833 30041 79050442
Blood creatine phosphokinase increased 88.07 10.09 270 663635 65820 79014663
Red blood cell sedimentation rate increased 87.58 10.09 669 663236 45273 79035210
Agranulocytosis 86.62 10.09 151 663754 44879 79035604
Anaphylactic shock 85.64 10.09 104 663801 35892 79044591
Temperature regulation disorder 84.99 10.09 165 663740 5688 79074795
Blood cholesterol increased 84.03 10.09 1066 662839 82654 78997829
Post transplant lymphoproliferative disorder 82.07 10.09 3 663902 11461 79069022
Intentional product misuse 80.11 10.09 464 663441 94701 78985782
Loss of personal independence in daily activities 79.94 10.09 1249 662656 101331 78979152
Anaemia 79.78 10.09 2965 660940 442050 78638433
Syncope 78.15 10.09 1038 662867 178411 78902072
Ventricular tachycardia 77.63 10.09 144 663761 41791 79038692
Mobility decreased 77.19 10.09 1438 662467 120737 78959746
Seizure 75.93 10.09 1110 662795 187724 78892759
Coeliac disease 75.43 10.09 237 663668 11114 79069369
Neurotoxicity 75.22 10.09 96 663809 32422 79048061
Inflammation 75.15 10.09 1147 662758 92606 78987877
Sedation 74.25 10.09 205 663700 51690 79028793
Myocardial infarction 74.15 10.09 1082 662823 183047 78897436
Gastrointestinal disorder 73.99 10.09 1429 662476 120776 78959707
Injection site erythema 73.58 10.09 984 662921 77213 79003270
Ear pain 73.27 10.09 497 663408 32372 79048111
Disability assessment scale score increased 73.06 10.09 115 663790 3343 79077140
Drug dependence 72.84 10.09 143 663762 40626 79039857
Foot deformity 72.76 10.09 394 663511 23680 79056803
Psychotic disorder 72.44 10.09 147 663758 41255 79039228
Osteoporosis 72.44 10.09 729 663176 53383 79027100
Night sweats 71.76 10.09 706 663199 51389 79029094
Cerebral haemorrhage 71.70 10.09 243 663662 57430 79023053
Musculoskeletal pain 71.13 10.09 1223 662682 101131 78979352
Eosinophilia 71.13 10.09 171 663734 45174 79035309
Blood pressure diastolic decreased 71.04 10.09 463 663442 29753 79050730
Venoocclusive liver disease 69.96 10.09 8 663897 11763 79068720
Disorientation 69.82 10.09 277 663628 62499 79017984
Carpal tunnel syndrome 69.80 10.09 335 663570 19193 79061290
Enthesopathy 69.59 10.09 234 663671 11374 79069109
Condition aggravated 69.55 10.09 4954 658951 496170 78584313
Injection site reaction 69.50 10.09 730 663175 54055 79026428
Cerebral infarction 69.49 10.09 175 663730 45501 79034982
Food allergy 69.19 10.09 223 663682 10601 79069882
Drug level increased 68.35 10.09 142 663763 39509 79040974
Polycystic ovaries 68.14 10.09 117 663788 3662 79076821
Cytokine release syndrome 68.07 10.09 122 663783 35876 79044607
Sensitisation 67.05 10.09 108 663797 3203 79077280
Aspergillus infection 67.02 10.09 38 663867 19123 79061360
Rash maculo-papular 65.89 10.09 242 663663 55836 79024647
Immune reconstitution inflammatory syndrome 65.71 10.09 17 663888 13824 79066659
Substance abuse 65.55 10.09 6 663899 10520 79069963
Heart rate decreased 65.40 10.09 883 663022 69433 79011050
Hypokalaemia 65.36 10.09 826 663079 143214 78937269
Torsade de pointes 65.15 10.09 40 663865 19272 79061211
Thrombotic microangiopathy 65.00 10.09 44 663861 20125 79060358
Hallucination 64.94 10.09 432 663473 85313 78995170
Encephalopathy 64.87 10.09 314 663591 67083 79013400
Ear infection 64.29 10.09 499 663406 33933 79046550
Interstitial lung disease 64.13 10.09 613 663292 111987 78968496
Myoclonus 63.63 10.09 82 663823 27578 79052905
Extrapyramidal disorder 63.56 10.09 57 663848 22622 79057861
Posterior reversible encephalopathy syndrome 63.52 10.09 75 663830 26206 79054277
Drug ineffective for unapproved indication 62.27 10.09 218 663687 51020 79029463
Miosis 61.72 10.09 27 663878 15762 79064721
Suicidal ideation 61.72 10.09 377 663528 75963 79004520
Akathisia 61.59 10.09 17 663888 13242 79067241
Rheumatoid nodule 61.50 10.09 298 663607 17140 79063343
Aggression 61.13 10.09 218 663687 50740 79029743
Toxic epidermal necrolysis 60.92 10.09 180 663725 44401 79036082
Stomatitis 60.91 10.09 1627 662278 145130 78935353
Joint range of motion decreased 60.86 10.09 480 663425 32802 79047681
Delirium 60.33 10.09 434 663471 84193 78996290
Bronchopulmonary aspergillosis 60.15 10.09 58 663847 22236 79058247
Haematotoxicity 59.94 10.09 27 663878 15492 79064991
Intentional product use issue 59.64 10.09 1674 662231 150438 78930045
Transplant rejection 59.24 10.09 45 663860 19392 79061091
Injection site pruritus 59.20 10.09 575 663330 41708 79038775
Mydriasis 58.88 10.09 37 663868 17606 79062877
Loss of consciousness 58.85 10.09 1013 662892 166930 78913553
Blood pressure diastolic increased 58.29 10.09 258 663647 14284 79066199
Gamma-glutamyltransferase increased 57.86 10.09 246 663659 54434 79026049
Femur fracture 57.79 10.09 533 663372 38119 79042364
Joint stiffness 57.54 10.09 556 663349 40274 79040209
Muscle spasticity 57.34 10.09 340 663565 21135 79059348
Ejection fraction 57.28 10.09 82 663823 2187 79078296
Palmar-plantar erythrodysaesthesia syndrome 56.82 10.09 119 663786 33015 79047468
Upper respiratory tract infection 56.52 10.09 1070 662835 90098 78990385
Blood pressure increased 56.42 10.09 2223 661682 209137 78871346
Live birth 56.13 10.09 306 663599 18438 79062045
Localised infection 56.10 10.09 518 663387 37057 79043426
Oropharyngeal pain 55.80 10.09 1247 662658 108106 78972377
Diabetic ketoacidosis 55.66 10.09 126 663779 33996 79046487
Inappropriate antidiuretic hormone secretion 55.53 10.09 83 663822 26230 79054253
Acute graft versus host disease 55.48 10.09 9 663896 10158 79070325
Tenosynovitis 54.99 10.09 266 663639 15288 79065195
Hypothermia 54.88 10.09 65 663840 22681 79057802
Abnormal behaviour 54.28 10.09 141 663764 36280 79044203
Haemophagocytic lymphohistiocytosis 54.20 10.09 61 663844 21776 79058707
Bone erosion 53.88 10.09 292 663613 17555 79062928
Acute generalised exanthematous pustulosis 53.81 10.09 39 663866 17215 79063268
Blood creatinine increased 53.77 10.09 937 662968 154120 78926363
Ischaemic stroke 53.51 10.09 123 663782 33008 79047475
Disturbance in attention 53.48 10.09 229 663676 50572 79029911
Proteinuria 53.04 10.09 120 663785 32382 79048101
Status epilepticus 52.83 10.09 79 663826 24962 79055521
Headache 52.39 10.09 6212 657693 647560 78432923
Mucormycosis 52.28 10.09 5 663900 8464 79072019
Joint destruction 52.28 10.09 137 663768 5788 79074695
Respiratory distress 52.06 10.09 279 663626 58060 79022423
Acute respiratory distress syndrome 51.88 10.09 190 663715 43877 79036606
Polyarthritis 51.60 10.09 220 663685 11982 79068501
Neoplasm progression 51.37 10.09 238 663667 51444 79029039
Asphyxia 50.87 10.09 17 663888 11703 79068780
Second primary malignancy 50.85 10.09 28 663877 14322 79066161
Ejection fraction decreased 50.66 10.09 135 663770 34442 79046041
Osteonecrosis of jaw 50.48 10.09 187 663718 43039 79037444
Exposure to toxic agent 50.21 10.09 8 663897 9150 79071333
Restlessness 49.91 10.09 208 663697 46284 79034199
Injection site pain 49.81 10.09 1425 662480 128413 78952070
Pyrexia 49.81 10.09 4920 658985 673789 78406694
Drug withdrawal syndrome 49.78 10.09 137 663768 34581 79045902
Joint laxity 49.59 10.09 78 663827 2266 79078217
Melaena 49.59 10.09 300 663605 60590 79019893
C-reactive protein increased 49.47 10.09 1416 662489 127611 78952872
Basal cell carcinoma 49.29 10.09 502 663403 36873 79043610
Neutrophil count decreased 49.15 10.09 522 663383 93437 78987046
Adverse event 49.14 10.09 739 663166 59475 79021008
Toxic skin eruption 48.34 10.09 69 663836 22224 79058259
Coombs positive haemolytic anaemia 48.03 10.09 53 663852 1077 79079406
Haemorrhage intracranial 47.55 10.09 91 663814 26102 79054381
Tremor 47.15 10.09 1067 662838 169016 78911467
Anaphylactic reaction 46.79 10.09 458 663447 83285 78997198
Pathogen resistance 46.61 10.09 31 663874 14311 79066172
Hypoxia 46.47 10.09 593 663312 102650 78977833
Drug use disorder 46.45 10.09 8 663897 8643 79071840
Unintentional medical device removal 46.45 10.09 5 663900 7707 79072776
Caesarean section 46.23 10.09 217 663688 12318 79068165
Pancreatitis acute 46.07 10.09 234 663671 49370 79031113
Multiple fractures 45.66 10.09 159 663746 7867 79072616
Dystonia 45.64 10.09 67 663838 21332 79059151
Tumour lysis syndrome 45.38 10.09 81 663824 23858 79056625
Hyperthermia 45.19 10.09 50 663855 17987 79062496
Accidental overdose 45.07 10.09 173 663732 39408 79041075
Injection site swelling 44.71 10.09 594 663311 46538 79033945
Neuropathy peripheral 43.98 10.09 870 663035 140435 78940048
Cardiac failure congestive 43.95 10.09 878 663027 141524 78938959
Septic shock 43.57 10.09 739 663166 122062 78958421
Sepsis 43.45 10.09 1817 662088 267611 78812872
Stevens-Johnson syndrome 43.44 10.09 173 663732 38993 79041490
Myelosuppression 43.43 10.09 180 663725 40116 79040367
Hallucination, visual 43.39 10.09 134 663771 32595 79047888
Psychomotor hyperactivity 42.99 10.09 46 663859 16803 79063680
Dysarthria 42.94 10.09 358 663547 67264 79013219
Blood bilirubin increased 42.81 10.09 349 663556 65883 79014600
Tongue disorder 42.42 10.09 229 663676 13746 79066737
Gestational diabetes 42.37 10.09 132 663773 6161 79074322
Nodule 42.25 10.09 332 663573 22662 79057821
Wrong technique in product usage process 42.13 10.09 402 663503 73473 79007010
Laryngitis 41.59 10.09 252 663653 15787 79064696
Synovial cyst 41.43 10.09 180 663725 9885 79070598
Cytomegalovirus viraemia 41.28 10.09 28 663877 12793 79067690
Disability 41.27 10.09 264 663641 16856 79063627
Dyskinesia 41.14 10.09 212 663693 44561 79035922
Face oedema 41.11 10.09 110 663795 28026 79052457
Muscle rigidity 40.72 10.09 64 663841 19818 79060665
Brain oedema 40.63 10.09 94 663811 25169 79055314
Pulmonary fibrosis 40.63 10.09 553 663352 43559 79036924
Labelled drug-drug interaction medication error 40.47 10.09 108 663797 27542 79052941
Crystal nephropathy 40.33 10.09 55 663850 1400 79079083
Jaundice 40.28 10.09 269 663636 53080 79027403
Tendonitis 39.96 10.09 337 663568 23493 79056990
Coagulopathy 39.96 10.09 159 663746 35847 79044636
Unresponsive to stimuli 39.81 10.09 286 663619 55502 79024981
BK virus infection 39.58 10.09 12 663893 8792 79071691
Arrhythmia 39.54 10.09 323 663582 60949 79019534
Graft versus host disease 39.50 10.09 40 663865 14986 79065497
No adverse event 38.93 10.09 168 663737 37024 79043459
Hepatotoxicity 38.74 10.09 259 663646 51093 79029390
Red blood cell sedimentation rate 38.65 10.09 118 663787 5447 79075036
Colorectal cancer 38.49 10.09 12 663893 8635 79071848
Spinal stenosis 38.37 10.09 244 663661 15547 79064936
Body temperature decreased 38.29 10.09 423 663482 31722 79048761
Polyneuropathy 37.93 10.09 91 663814 24060 79056423
Gastroenteritis viral 37.92 10.09 344 663561 24487 79055996
Erythema multiforme 37.91 10.09 55 663850 17596 79062887
Acute myeloid leukaemia 37.80 10.09 131 663774 30754 79049729
Hypomagnesaemia 37.74 10.09 232 663673 46679 79033804
Herpes zoster 37.48 10.09 1028 662877 92055 78988428
Respiratory depression 37.43 10.09 112 663793 27518 79052965
Tenderness 37.37 10.09 330 663575 23312 79057171
Bradyphrenia 37.36 10.09 21 663884 10619 79069864
Tachypnoea 37.25 10.09 139 663766 31924 79048559
Acute graft versus host disease in skin 37.14 10.09 9 663896 7649 79072834
Weight decreased 36.85 10.09 3435 660470 351763 78728720
Alanine aminotransferase abnormal 36.82 10.09 159 663746 8708 79071775
Hepatitis B reactivation 36.68 10.09 4 663901 6104 79074379
Stress cardiomyopathy 36.47 10.09 24 663881 11142 79069341
Shock haemorrhagic 36.15 10.09 70 663835 19990 79060493
Injection site bruising 36.13 10.09 510 663395 40492 79039991
Graft versus host disease in gastrointestinal tract 36.12 10.09 5 663900 6351 79074132
Metastases to liver 36.08 10.09 118 663787 28196 79052287
Hypertransaminasaemia 35.84 10.09 28 663877 11896 79068587
Influenza 35.70 10.09 1368 662537 128238 78952245
Bronchitis 35.53 10.09 1377 662528 129267 78951216
Adenovirus infection 35.38 10.09 13 663892 8434 79072049
Latent tuberculosis 35.36 10.09 83 663822 3270 79077213
Anuria 35.35 10.09 76 663829 20887 79059596
Exostosis 35.27 10.09 251 663654 16607 79063876
Dyspnoea 35.17 10.09 6442 657463 850583 78229900
Vomiting 35.07 10.09 4934 658971 660894 78419589
Febrile bone marrow aplasia 34.98 10.09 34 663871 12986 79067497
Hyperbilirubinaemia 34.96 10.09 97 663808 24421 79056062
Clostridium difficile colitis 34.92 10.09 144 663761 32139 79048344
Hallucination, auditory 34.91 10.09 75 663830 20618 79059865
Pemphigoid 34.61 10.09 46 663859 15269 79065214
Neck deformity 34.61 10.09 58 663847 1779 79078704
Oral herpes 34.43 10.09 365 663540 27089 79053394
Mania 34.42 10.09 62 663843 18198 79062285
Rhinorrhoea 34.06 10.09 852 663053 75222 79005261
Tubulointerstitial nephritis 34.03 10.09 183 663722 38052 79042431
Cardiotoxicity 34.01 10.09 31 663874 12208 79068275
Irritability 33.88 10.09 202 663703 40942 79039541
Hypocalcaemia 33.68 10.09 260 663645 49664 79030819
Urinary retention 33.65 10.09 305 663600 56325 79024158
Joint injury 33.59 10.09 404 663501 30931 79049552
Hyperammonaemia 33.40 10.09 26 663879 11067 79069416
Dehydration 33.12 10.09 1708 662197 246479 78834004
Speech disorder 32.89 10.09 292 663613 54153 79026330
Back pain 32.66 10.09 2949 660956 301231 78779252
Arthritis infective 32.59 10.09 146 663759 8125 79072358
Acute coronary syndrome 32.12 10.09 81 663824 21052 79059431
Chronic kidney disease 32.03 10.09 374 663531 65780 79014703
Atrial fibrillation 31.99 10.09 1334 662571 196552 78883931
Haemodynamic instability 31.89 10.09 60 663845 17322 79063161
Acute chest syndrome 31.72 10.09 51 663854 1510 79078973
Sciatica 31.63 10.09 419 663486 32803 79047680
Blood test abnormal 31.60 10.09 254 663651 17456 79063027
Bronchospasm 31.40 10.09 104 663801 24755 79055728
Red blood cell count decreased 31.29 10.09 662 663243 56851 79023632
Forced expiratory volume decreased 31.12 10.09 13 663892 7801 79072682
Nocardiosis 31.05 10.09 5 663900 5674 79074809
Sinus bradycardia 30.95 10.09 107 663798 25140 79055343
Chronic graft versus host disease 30.93 10.09 9 663896 6772 79073711
Epstein-Barr virus infection 30.88 10.09 45 663860 14371 79066112
Hemiplegia 30.68 10.09 48 663857 14891 79065592
Maternal exposure before pregnancy 30.63 10.09 93 663812 4280 79076203
Electrocardiogram QRS complex prolonged 30.63 10.09 27 663878 10806 79069677
Pre-eclampsia 30.59 10.09 128 663777 6913 79073570
Angina pectoris 30.57 10.09 279 663626 51453 79029030
Hyperhidrosis 30.37 10.09 995 662910 150497 78929986
Pulmonary oedema 30.36 10.09 534 663371 87720 78992763
Skin ulcer 30.35 10.09 626 663279 53524 79026959
Hyperuricaemia 30.34 10.09 32 663873 11767 79068716
Myalgia 30.32 10.09 1250 662655 184391 78896092
Coronary artery disease 30.23 10.09 374 663531 65100 79015383
Neck mass 30.23 10.09 93 663812 4311 79076172
Injection site rash 30.16 10.09 254 663651 17700 79062783
Subdural haematoma 29.93 10.09 147 663758 31287 79049196
Bone density decreased 29.85 10.09 202 663703 13145 79067338
Acute myocardial infarction 29.84 10.09 456 663449 76580 79003903
Foot fracture 29.83 10.09 297 663608 21684 79058799
Bone disorder 29.81 10.09 266 663639 18847 79061636
Lip dry 29.65 10.09 225 663680 15193 79065290
Type 2 diabetes mellitus 29.64 10.09 653 663252 56469 79024014
Cytopenia 29.54 10.09 80 663825 20303 79060180
Hypoaesthesia 29.45 10.09 1799 662106 177553 78902930
Blood glucose increased 29.44 10.09 730 663175 114245 78966238
Therapy partial responder 29.40 10.09 63 663842 17334 79063149
Smear cervix abnormal 29.21 10.09 65 663840 2471 79078012
Wound infection 29.17 10.09 317 663588 23674 79056809
Hepatitis cholestatic 28.93 10.09 44 663861 13808 79066675
Sinus tachycardia 28.93 10.09 184 663721 36724 79043759
Ileus 28.93 10.09 116 663789 26095 79054388
Cardiac failure chronic 28.86 10.09 30 663875 11105 79069378
Peripheral venous disease 28.84 10.09 229 663676 15680 79064803
Bone marrow failure 28.76 10.09 279 663626 50828 79029655
Potentiating drug interaction 28.74 10.09 19 663886 8800 79071683
Limb deformity 28.66 10.09 80 663825 3510 79076973
Breast cancer stage I 28.59 10.09 10 663895 6690 79073793
Product administration error 28.58 10.09 152 663753 31694 79048789
Aphasia 28.51 10.09 250 663655 46482 79034001
Accidental exposure to product 28.39 10.09 149 663756 31173 79049310
Fracture 28.35 10.09 292 663613 21509 79058974
Catatonia 28.35 10.09 19 663886 8737 79071746
Metastases to bone 28.31 10.09 106 663799 24321 79056162
Cystitis haemorrhagic 28.25 10.09 21 663884 9151 79071332
Nephropathy toxic 28.22 10.09 82 663823 20337 79060146
Cataract 28.19 10.09 697 663208 61423 79019060
Cytomegalovirus infection reactivation 28.11 10.09 19 663886 8697 79071786
Parkinsonism 28.07 10.09 60 663845 16524 79063959
Device use error 27.99 10.09 12 663893 7089 79073394
Tardive dyskinesia 27.94 10.09 28 663877 10543 79069940
Wheelchair user 27.84 10.09 113 663792 6019 79074464
Facet joint syndrome 27.69 10.09 175 663730 11127 79069356
Oliguria 27.61 10.09 59 663846 16250 79064233
Venoocclusive disease 27.45 10.09 3 663902 4570 79075913
Pulmonary arterial hypertension 27.38 10.09 132 663773 28234 79052249
Pulmonary alveolar haemorrhage 27.36 10.09 33 663872 11424 79069059
Pancreatitis 27.22 10.09 404 663501 68171 79012312
Transplant dysfunction 27.21 10.09 13 663892 7208 79073275
Foot operation 27.11 10.09 107 663798 5626 79074857
Muscle twitching 27.07 10.09 110 663795 24654 79055829
Off label use 26.90 10.09 6928 656977 900287 78180196
Generalised tonic-clonic seizure 26.74 10.09 235 663670 43675 79036808
Device difficult to use 26.55 10.09 44 663861 13341 79067142
Klebsiella infection 26.50 10.09 57 663848 15663 79064820
Withdrawal syndrome 26.49 10.09 124 663781 26730 79053753
Jaundice cholestatic 26.42 10.09 33 663872 11251 79069232
Mental status changes 26.40 10.09 395 663510 66564 79013919
Nephrectomy 26.40 10.09 56 663849 2059 79078424
Haematemesis 26.27 10.09 293 663612 51971 79028512
Haemoptysis 26.19 10.09 319 663586 55680 79024803
Cardiac failure acute 26.17 10.09 76 663829 18853 79061630
Premature rupture of membranes 26.16 10.09 84 663821 3985 79076498
Haematoma 26.08 10.09 293 663612 51902 79028581
Body temperature increased 26.05 10.09 517 663388 43903 79036580
Graft versus host disease in skin 26.03 10.09 9 663896 6064 79074419
Hepatic encephalopathy 26.01 10.09 108 663797 24058 79056425
Hyperthyroidism 25.98 10.09 96 663809 22113 79058370
Hepatitis fulminant 25.98 10.09 14 663891 7248 79073235
Dysphagia 25.97 10.09 796 663109 121340 78959143
Lip swelling 25.79 10.09 217 663688 40694 79039789
Cytomegalovirus chorioretinitis 25.57 10.09 7 663898 5483 79075000
Gastrointestinal haemorrhage 25.55 10.09 988 662917 146731 78933752
Metastases to central nervous system 25.48 10.09 62 663843 16313 79064170
Acidosis 25.43 10.09 82 663823 19680 79060803
Glycosylated haemoglobin increased 25.43 10.09 79 663826 19181 79061302
Cellulitis 25.43 10.09 1131 662774 107929 78972554
Oesophageal carcinoma 25.35 10.09 33 663872 11051 79069432
Fracture delayed union 25.34 10.09 55 663850 2055 79078428
Schizophrenia 25.20 10.09 57 663848 15383 79065100
Blood parathyroid hormone decreased 25.11 10.09 162 663743 10374 79070109
Obstructive airways disorder 25.09 10.09 156 663749 31303 79049180
Rotator cuff repair 25.09 10.09 51 663854 1819 79078664
Metastases to lung 25.06 10.09 73 663832 18090 79062393
Joint dislocation 25.02 10.09 233 663672 16706 79063777
Poor venous access 25.01 10.09 246 663659 17903 79062580
Granuloma skin 24.98 10.09 146 663759 9028 79071455
Sexual dysfunction 24.93 10.09 17 663888 7746 79072737
Multiple-drug resistance 24.85 10.09 22 663883 8786 79071697
Skin papilloma 24.79 10.09 106 663799 5780 79074703
Progressive multifocal leukoencephalopathy 24.79 10.09 88 663817 20512 79059971
Lupus vasculitis 24.53 10.09 27 663878 547 79079936
Hyperlactacidaemia 24.49 10.09 8 663897 5587 79074896
Malignant mediastinal neoplasm 24.46 10.09 43 663862 1372 79079111
Haematocrit decreased 24.36 10.09 676 663229 60636 79019847
Blood lactic acid increased 24.27 10.09 43 663862 12701 79067782
Product quality issue 24.21 10.09 174 663731 33766 79046717
Obesity 24.13 10.09 419 663486 34706 79045777
Leukocytosis 24.13 10.09 238 663667 43217 79037266
Dry eye 24.11 10.09 437 663468 36494 79043989
Infection susceptibility increased 24.09 10.09 77 663828 3644 79076839
Haemoglobin decreased 24.06 10.09 2155 661750 219964 78860519
Hemiparesis 24.03 10.09 173 663732 33560 79046923
Respiratory acidosis 23.95 10.09 35 663870 11165 79069318
Myocardial ischaemia 23.91 10.09 120 663785 25399 79055084
Hepatocellular carcinoma 23.73 10.09 24 663881 8997 79071486
Delusion 23.42 10.09 89 663816 20334 79060149
Ankylosing spondylitis 23.41 10.09 178 663727 12027 79068456
Maternal exposure timing unspecified 23.39 10.09 103 663802 5689 79074794
Pneumatosis intestinalis 23.38 10.09 12 663893 6385 79074098
Transaminases increased 23.35 10.09 297 663608 51446 79029037
Hepatitis acute 23.29 10.09 60 663845 15482 79065001
Blood alkaline phosphatase increased 23.27 10.09 381 663524 63283 79017200
Cyanosis 23.27 10.09 119 663786 25063 79055420
Affective disorder 23.20 10.09 21 663884 8298 79072185
Ejection fraction abnormal 23.17 10.09 58 663847 2382 79078101
Premature labour 23.15 10.09 134 663771 8256 79072227
Bladder cancer 23.11 10.09 84 663821 19442 79061041
Pleural effusion 23.10 10.09 981 662924 144281 78936202
Disease recurrence 23.08 10.09 245 663660 43864 79036619
Fear of injection 23.04 10.09 123 663782 7351 79073132
Ulcer 22.98 10.09 364 663541 29608 79050875
Subarachnoid haemorrhage 22.95 10.09 115 663790 24350 79056133
Skin cancer 22.78 10.09 208 663697 14832 79065651
Aplasia 22.71 10.09 19 663886 7801 79072682
Ileus paralytic 22.67 10.09 28 663877 9592 79070891
Haemorrhage 22.66 10.09 581 663324 90537 78989946
Renal injury 22.65 10.09 69 663836 16858 79063625
Bradypnoea 22.65 10.09 11 663894 6041 79074442
Fear 22.59 10.09 100 663805 21886 79058597
Personality change 22.52 10.09 31 663874 10139 79070344
Polyuria 22.47 10.09 58 663847 14956 79065527
Tuberculosis 22.42 10.09 209 663696 14989 79065494
Hypoalbuminaemia 22.41 10.09 96 663809 21201 79059282
Musculoskeletal disorder 22.32 10.09 275 663630 21173 79059310
Cyst 22.30 10.09 194 663711 13646 79066837
Pruritus genital 22.29 10.09 5 663900 4481 79076002
Hypernatraemia 22.26 10.09 55 663850 14396 79066087
Virologic failure 22.23 10.09 4 663901 4187 79076296
Peripheral sensory neuropathy 22.19 10.09 47 663858 12986 79067497
Lymphadenitis 22.11 10.09 87 663818 4568 79075915
Sleep terror 22.09 10.09 5 663900 4453 79076030
Tenosynovitis stenosans 22.07 10.09 66 663839 3012 79077471
Diabetes insipidus 22.04 10.09 8 663897 5229 79075254
Blood lactate dehydrogenase increased 21.97 10.09 214 663691 38956 79041527
Premature delivery 21.94 10.09 295 663610 23172 79057311
Disturbance in social behaviour 21.94 10.09 7 663898 4963 79075520
Gastric haemorrhage 21.87 10.09 59 663846 14991 79065492
Ascites 21.79 10.09 471 663434 75091 79005392
Hyperprolactinaemia 21.71 10.09 6 663899 4670 79075813
Rebound effect 21.68 10.09 17 663888 7209 79073274
Bradykinesia 21.61 10.09 21 663884 8022 79072461
Circulatory collapse 21.46 10.09 205 663700 37463 79043020
Lower limb fracture 21.36 10.09 291 663614 22924 79057559
Pulmonary congestion 21.29 10.09 135 663770 26965 79053518
Nightmare 21.27 10.09 127 663778 25734 79054749
Colitis ulcerative 21.26 10.09 407 663498 34335 79046148
Foetal death 21.25 10.09 127 663778 7917 79072566
Scleritis 21.17 10.09 82 663823 4274 79076209
Lymphopenia 21.15 10.09 158 663747 30399 79050084
Diabetes mellitus inadequate control 21.12 10.09 117 663788 24147 79056336
Hepatic cytolysis 20.95 10.09 136 663769 27015 79053468
Intracranial pressure increased 20.92 10.09 23 663882 8299 79072184
Accidental death 20.89 10.09 5 663900 4286 79076197
Haemolysis 20.86 10.09 180 663725 12632 79067851
Endophthalmitis 20.74 10.09 14 663891 6414 79074069
Deep vein thrombosis postoperative 20.73 10.09 157 663748 10595 79069888
Anti-cyclic citrullinated peptide antibody 20.63 10.09 100 663805 5752 79074731
Adjustment disorder with depressed mood 20.61 10.09 138 663767 8948 79071535
Victim of child abuse 20.56 10.09 32 663873 921 79079562
Dislocation of vertebra 20.55 10.09 124 663781 7756 79072727
Ventricular arrhythmia 20.55 10.09 26 663879 8814 79071669
Immunosuppressant drug level increased 20.52 10.09 27 663878 9000 79071483
Acute pulmonary oedema 20.51 10.09 56 663849 14174 79066309
Pharyngitis streptococcal 20.41 10.09 156 663749 10558 79069925
Injury 20.40 10.09 814 663091 76682 79003801
Retinitis 20.31 10.09 97 663808 5546 79074937
Joint noise 20.29 10.09 76 663829 3898 79076585
Enterocolitis 20.26 10.09 58 663847 14454 79066029
Synovial fluid analysis 20.26 10.09 54 663851 2305 79078178
Acute lymphocytic leukaemia recurrent 20.25 10.09 7 663898 4717 79075766
Post procedural infection 20.16 10.09 163 663742 11221 79069262
Strongyloidiasis 20.08 10.09 4 663901 3894 79076589
Malignant melanoma 19.92 10.09 199 663706 14542 79065941
Immune effector cell-associated neurotoxicity syndrome 19.88 10.09 12 663893 5836 79074647
Gastrooesophageal reflux disease 19.87 10.09 1060 662845 103186 78977297
Body tinea 19.67 10.09 46 663859 1808 79078675
Prescribed overdose 19.63 10.09 433 663472 37450 79043033
Cognitive disorder 19.55 10.09 438 663467 69488 79010995
Pruritus 19.49 10.09 3649 660256 390999 78689484
Mass 19.49 10.09 227 663678 17245 79063238
Surgery 19.43 10.09 382 663523 32384 79048099
Loose body in joint 19.41 10.09 37 663868 1258 79079225
Urinary tract infection 19.39 10.09 2589 661316 271923 78808560
Cholangitis 19.39 10.09 49 663856 12727 79067756
Sudden death 19.34 10.09 109 663796 22402 79058081
Mucosal inflammation 19.31 10.09 480 663425 75100 79005383
Hypoxic-ischaemic encephalopathy 19.24 10.09 22 663883 7798 79072685
Device expulsion 19.22 10.09 131 663774 25730 79054753
Nasal congestion 19.21 10.09 800 663105 75752 79004731
Panniculitis 19.20 10.09 172 663733 12199 79068284
Kidney transplant rejection 19.12 10.09 35 663870 10211 79070272
Acute graft versus host disease in intestine 19.11 10.09 5 663900 4036 79076447
Injection site warmth 19.10 10.09 198 663707 14609 79065874
Atrioventricular block 18.96 10.09 57 663848 13984 79066499
Endodontic procedure 18.90 10.09 58 663847 2685 79077798
Psychomotor skills impaired 18.88 10.09 10 663895 5227 79075256
Hypomania 18.80 10.09 21 663884 7523 79072960
Dermatitis acneiform 18.77 10.09 34 663871 9959 79070524
Therapeutic response decreased 18.73 10.09 707 663198 66146 79014337
Synovial disorder 18.68 10.09 47 663858 1936 79078547
Atrioventricular block complete 18.65 10.09 73 663832 16537 79063946
Finger deformity 18.48 10.09 116 663789 7358 79073125
Burning sensation 18.37 10.09 628 663277 58004 79022479
Nausea 18.32 10.09 7438 656467 949758 78130725
Capillary leak syndrome 18.29 10.09 5 663900 3920 79076563
Human herpesvirus 6 infection 18.28 10.09 11 663894 5359 79075124
Myocarditis 18.26 10.09 106 663799 21627 79058856
Deafness transitory 18.19 10.09 31 663874 964 79079519
Pulseless electrical activity 18.05 10.09 59 663846 14101 79066382
Alcohol interaction 18.03 10.09 9 663896 4865 79075618
Hydrops foetalis 18.02 10.09 27 663878 751 79079732
Abdominal pain upper 18.01 10.09 2128 661777 221691 78858792
Myopathy 17.98 10.09 99 663806 20464 79060019
Cerebrovascular accident 17.90 10.09 1084 662821 154208 78926275
Compartment syndrome 17.89 10.09 10 663895 5072 79075411
Amylase increased 17.79 10.09 42 663863 11167 79069316
Lupus-like syndrome 17.74 10.09 185 663720 13672 79066811
Device related infection 17.74 10.09 191 663714 34103 79046380
Tooth disorder 17.69 10.09 312 663593 25921 79054562
Osteopenia 17.64 10.09 232 663673 18132 79062351
Intervertebral disc degeneration 17.57 10.09 205 663700 15580 79064903
Pseudomonas infection 17.54 10.09 102 663803 20801 79059682
Rheumatoid lung 17.53 10.09 76 663829 4169 79076314
Right ventricular failure 17.48 10.09 119 663786 23378 79057105
Ultrasound antenatal screen 17.43 10.09 25 663880 668 79079815
Antinuclear antibody positive 17.40 10.09 119 663786 7771 79072712
Cleft lip and palate 17.29 10.09 25 663880 673 79079810
Toxic encephalopathy 17.27 10.09 44 663861 11396 79069087
Spinal osteoarthritis 17.17 10.09 216 663689 16711 79063772
Anxiety 17.11 10.09 1809 662096 246703 78833780
Product monitoring error 17.00 10.09 30 663875 8876 79071607
Laryngospasm 17.00 10.09 6 663899 3991 79076492
Platelet count decreased 16.99 10.09 1392 662513 193272 78887211
Kidney infection 16.99 10.09 266 663639 21585 79058898
Device leakage 16.97 10.09 41 663864 10815 79069668
Immune-mediated myositis 16.96 10.09 4 663901 3463 79077020
Drug tolerance decreased 16.96 10.09 174 663731 12804 79067679
Anti-neutrophil cytoplasmic antibody positive vasculitis 16.92 10.09 5 663900 3724 79076759
Skin toxicity 16.80 10.09 27 663878 8287 79072196
Persecutory delusion 16.79 10.09 10 663895 4899 79075584
Pulmonary embolism 16.61 10.09 1217 662688 170437 78910046
Blood pressure decreased 16.60 10.09 668 663237 98798 78981685
Linear IgA disease 16.59 10.09 3 663902 3129 79077354
Personality disorder 16.57 10.09 16 663889 6130 79074353
Nasal polyps 16.57 10.09 22 663883 7305 79073178
Pulmonary hypertension 16.51 10.09 291 663614 47789 79032694
Epilepsy 16.47 10.09 240 663665 40620 79039863
Type I hypersensitivity 16.45 10.09 8 663897 4390 79076093
Neutropenic colitis 16.41 10.09 14 663891 5693 79074790
Knee operation 16.39 10.09 94 663811 5772 79074711
Acute myeloid leukaemia recurrent 16.36 10.09 4 663901 3379 79077104
Vascular purpura 16.34 10.09 3 663902 3095 79077388
Rash pruritic 16.29 10.09 741 663164 70888 79009595
Aspartate aminotransferase increased 16.29 10.09 966 662939 137675 78942808
Hepatic cancer 16.28 10.09 40 663865 10489 79069994
Gastric cancer 16.27 10.09 38 663867 10141 79070342
Hyperpyrexia 16.26 10.09 16 663889 6076 79074407
Renal cancer 16.25 10.09 50 663855 12176 79068307
Nervous system disorder 16.23 10.09 144 663761 26712 79053771
Renal tubular disorder 16.23 10.09 18 663887 6468 79074015
Ingrown hair 16.15 10.09 25 663880 716 79079767
Tooth infection 16.10 10.09 233 663672 18599 79061884
Coronary artery bypass 16.09 10.09 16 663889 6046 79074437
Pneumocystis jirovecii pneumonia 16.04 10.09 183 663722 32325 79048158
Dry mouth 15.99 10.09 891 663014 87128 78993355
Hepatitis B 15.97 10.09 28 663877 8304 79072179
Cardiogenic shock 15.93 10.09 249 663656 41665 79038818
Pneumonia bacterial 15.86 10.09 95 663810 19236 79061247
Road traffic accident 15.85 10.09 476 663429 43188 79037295
Heart rate irregular 15.83 10.09 370 663535 32309 79048174
Cystitis 15.82 10.09 562 663343 52170 79028313
Mouth ulceration 15.73 10.09 425 663480 37969 79042514
Spinal disorder 15.59 10.09 142 663763 10118 79070365
Heparin-induced thrombocytopenia 15.59 10.09 36 663869 9646 79070837
Human antichimeric antibody positive 15.57 10.09 39 663866 1602 79078881
Epstein-Barr virus associated lymphoproliferative disorder 15.55 10.09 5 663900 3527 79076956
Atrial tachycardia 15.54 10.09 22 663883 7111 79073372
Incoherent 15.53 10.09 25 663880 7667 79072816
Product administered to patient of inappropriate age 15.51 10.09 14 663891 5539 79074944
Breast feeding 15.49 10.09 24 663881 688 79079795
Cell death 15.48 10.09 10 663895 4689 79075794
Left ventricular dysfunction 15.44 10.09 96 663809 19265 79061218
Dyspnoea at rest 15.44 10.09 23 663882 7279 79073204
Ketoacidosis 15.41 10.09 26 663879 7828 79072655
Hypercapnia 15.40 10.09 32 663873 8903 79071580
Paralysis 15.39 10.09 57 663848 13120 79067363
Trisomy 18 15.36 10.09 22 663883 587 79079896
Nephrotic syndrome 15.35 10.09 45 663860 11129 79069354
Pneumonia aspiration 15.34 10.09 432 663473 66535 79013948
Metastasis 15.21 10.09 21 663884 6859 79073624
Eye infection 15.19 10.09 159 663746 11761 79068722
Postoperative wound infection 15.18 10.09 170 663735 12791 79067692
Psychiatric decompensation 15.14 10.09 7 663898 3956 79076527
Dermatitis bullous 15.12 10.09 64 663841 14181 79066302
Intestinal ischaemia 15.11 10.09 58 663847 13212 79067271
Accidental exposure to product by child 15.08 10.09 3 663902 2923 79077560
Congestive cardiomyopathy 15.07 10.09 49 663856 11731 79068752
Cross sensitivity reaction 15.07 10.09 6 663899 3706 79076777
Inadequate analgesia 15.05 10.09 10 663895 4619 79075864
Haematuria 15.03 10.09 447 663458 68389 79012094
Muscle swelling 15.02 10.09 26 663879 819 79079664
Cartilage injury 14.99 10.09 37 663868 1506 79078977
Neutrophilia 14.98 10.09 27 663878 7924 79072559
Osteonecrosis 14.97 10.09 176 663729 30919 79049564
Wrong product administered 14.93 10.09 33 663872 8979 79071504
Palpitations 14.90 10.09 882 663023 125728 78954755
Metabolic disorder 14.84 10.09 34 663871 9136 79071347
End stage renal disease 14.84 10.09 52 663853 12168 79068315
Gastrointestinal pain 14.78 10.09 136 663769 9719 79070764
Impaired work ability 14.70 10.09 238 663667 19443 79061040
Body height below normal 14.70 10.09 44 663861 2009 79078474
Decreased appetite 14.68 10.09 2567 661338 339851 78740632
Eosinophil count increased 14.60 10.09 83 663822 17022 79063461
Dermatitis exfoliative 14.59 10.09 44 663861 10785 79069698
Orthostatic hypotension 14.53 10.09 356 663549 55808 79024675
Retinal haemorrhage 14.52 10.09 29 663876 8188 79072295
Complications of transplanted kidney 14.51 10.09 19 663886 6347 79074136
Pulmonary haemorrhage 14.49 10.09 68 663837 14649 79065834
Confusional state 14.47 10.09 2376 661529 315621 78764862
Blood folate increased 14.46 10.09 20 663885 516 79079967
Induced labour 14.43 10.09 26 663879 846 79079637
Type 1 diabetes mellitus 14.43 10.09 22 663883 6897 79073586
Oxalosis 14.42 10.09 10 663895 105 79080378
Alcohol abuse 14.41 10.09 14 663891 5349 79075134
Hydrocephalus 14.41 10.09 33 663872 8867 79071616
Generalised oedema 14.39 10.09 127 663778 23582 79056901
Acute lung injury 14.35 10.09 4 663901 3096 79077387
Metastases to meninges 14.33 10.09 6 663899 3595 79076888
Nephrolithiasis 14.31 10.09 561 663344 52730 79027753
Hypertriglyceridaemia 14.30 10.09 56 663849 12684 79067799
Erectile dysfunction 14.29 10.09 68 663837 14596 79065887
Cogwheel rigidity 14.27 10.09 4 663901 3084 79077399
Foetal distress syndrome 14.25 10.09 19 663886 473 79080010
Ankle arthroplasty 14.22 10.09 36 663869 1489 79078994
Paranoia 14.16 10.09 99 663806 19333 79061150
Abortion incomplete 14.10 10.09 4 663901 3060 79077423
Bone density increased 14.08 10.09 25 663880 804 79079679
Drug-induced liver injury 14.03 10.09 431 663474 65686 79014797
Injection site urticaria 14.02 10.09 166 663739 12660 79067823
Vertigo 14.01 10.09 453 663452 68629 79011854
Lipase increased 14.00 10.09 80 663825 16386 79064097
Toothache 14 10.09 239 663666 19731 79060752
Leukoencephalopathy 14 10.09 28 663877 7901 79072582
Short stature 13.99 10.09 23 663882 694 79079789
Pharyngitis 13.99 10.09 263 663642 22112 79058371
Autoimmune disorder 13.99 10.09 205 663700 16407 79064076
Partial seizures 13.96 10.09 34 663871 8944 79071539
Ataxia 13.96 10.09 137 663768 24902 79055581
Sickle cell anaemia 13.92 10.09 22 663883 642 79079841
Drug dose omission by device 13.89 10.09 19 663886 6231 79074252
Tooth fracture 13.86 10.09 152 663753 11378 79069105
Diabetes mellitus 13.84 10.09 523 663382 77867 79002616
Polydipsia 13.78 10.09 21 663884 6584 79073899
Hernia 13.77 10.09 209 663696 16850 79063633
Steroid diabetes 13.70 10.09 6 663899 3500 79076983
Electrolyte imbalance 13.66 10.09 178 663727 30703 79049780
Hepatitis C 13.65 10.09 52 663853 11873 79068610
Hypertensive crisis 13.62 10.09 109 663796 20661 79059822
Glomerular filtration rate decreased 13.60 10.09 122 663783 22580 79057903
Palmoplantar keratoderma 13.54 10.09 7 663898 3709 79076774
Increased tendency to bruise 13.53 10.09 140 663765 10324 79070159
Stillbirth 13.53 10.09 67 663838 3888 79076595
Cestode infection 13.51 10.09 14 663891 264 79080219
Bacteraemia 13.51 10.09 192 663713 32632 79047851
Ligament rupture 13.44 10.09 60 663845 3334 79077149
Lymph gland infection 13.44 10.09 20 663885 553 79079930
Polyhydramnios 13.41 10.09 38 663867 1682 79078801
Injection site haemorrhage 13.33 10.09 315 663590 27555 79052928
Vision blurred 13.32 10.09 733 663172 105165 78975318
Oculogyric crisis 13.32 10.09 4 663901 2948 79077535
Lupus nephritis 13.31 10.09 55 663850 2953 79077530
Presyncope 13.30 10.09 251 663654 40803 79039680
Lymphocyte count decreased 13.28 10.09 296 663609 46993 79033490
Salivary hypersecretion 13.26 10.09 67 663838 14157 79066326
Cerebral haematoma 13.22 10.09 29 663876 7913 79072570
Candida infection 13.21 10.09 231 663674 37983 79042500
Hypoventilation 13.20 10.09 25 663880 7199 79073284
Maternal exposure during breast feeding 13.19 10.09 52 663853 2733 79077750
Placental disorder 13.18 10.09 26 663879 907 79079576
Lower respiratory tract congestion 13.17 10.09 67 663838 3930 79076553
Drug tolerance 13.15 10.09 120 663785 8555 79071928
Meniscus injury 13.14 10.09 99 663806 6669 79073814
Systemic inflammatory response syndrome 13.12 10.09 50 663855 11415 79069068
Rhinitis allergic 13.07 10.09 158 663747 12111 79068372
Neurologic neglect syndrome 13.00 10.09 4 663901 2903 79077580
Congenital neuropathy 12.97 10.09 5 663900 12 79080471
Mental disorder 12.92 10.09 183 663722 31119 79049364
Drug screen positive 12.91 10.09 19 663886 6044 79074439
Encephalitis toxic 12.90 10.09 14 663891 279 79080204
Hiatus hernia 12.90 10.09 269 663636 23043 79057440
Anticholinergic syndrome 12.86 10.09 7 663898 3604 79076879
Skin laceration 12.85 10.09 324 663581 28638 79051845
Wound infection pseudomonas 12.82 10.09 36 663869 1585 79078898
Coronary arterial stent insertion 12.82 10.09 19 663886 6025 79074458
Metastases to lymph nodes 12.79 10.09 44 663861 10353 79070130
Joint lock 12.76 10.09 57 663848 3168 79077315
Arthropod bite 12.75 10.09 117 663788 8354 79072129
Pleuritic pain 12.74 10.09 135 663770 10017 79070466
Coordination abnormal 12.72 10.09 88 663817 17224 79063259
Limb injury 12.71 10.09 329 663576 29199 79051284
Pulmonary pain 12.71 10.09 72 663833 4401 79076082
Mitochondrial toxicity 12.70 10.09 5 663900 3109 79077374
Hypogammaglobulinaemia 12.66 10.09 60 663845 12891 79067592
Drug abuser 12.65 10.09 19 663886 5994 79074489
Drug ineffective 12.65 10.09 9477 654428 1071436 78009047
Rheumatic disorder 12.63 10.09 56 663849 3102 79077381
Radiation inflammation 12.52 10.09 25 663880 880 79079603
Wrist fracture 12.47 10.09 153 663752 11768 79068715
International normalised ratio increased 12.47 10.09 577 663328 84144 78996339
Rhinovirus infection 12.46 10.09 30 663875 7923 79072560
Frequent bowel movements 12.39 10.09 328 663577 29211 79051272
Mixed liver injury 12.35 10.09 28 663877 7550 79072933
Antibody test positive 12.32 10.09 51 663854 2741 79077742
Carotid artery thrombosis 12.29 10.09 5 663900 3048 79077435
Lacrimal disorder 12.27 10.09 18 663887 491 79079992
Hypoglycaemic coma 12.14 10.09 13 663892 4747 79075736
Swollen tongue 12.09 10.09 266 663639 42304 79038179
Colitis 12.09 10.09 493 663412 72814 79007669
Diaphragmatic disorder 12.05 10.09 37 663868 1713 79078770
Bone density abnormal 12.04 10.09 54 663851 3006 79077477
Secondary adrenocortical insufficiency 12.03 10.09 5 663900 3009 79077474
Bacterial sepsis 12.01 10.09 32 663873 8166 79072317
Genital haemorrhage 12.01 10.09 21 663884 6234 79074249
Onychomycosis 11.89 10.09 113 663792 8148 79072335
Injection site extravasation 11.87 10.09 128 663777 9541 79070942
Dizziness 11.82 10.09 4066 659839 522375 78558108
Cervical incompetence 11.80 10.09 18 663887 509 79079974
Tetany 11.77 10.09 4 663901 2724 79077759
Liver injury 11.67 10.09 580 663325 56034 79024449
Blood urea increased 11.63 10.09 313 663592 48477 79032006
Dysstasia 11.61 10.09 308 663597 27438 79053045
Immunosuppression 11.58 10.09 160 663745 12643 79067840
Hypertonia 11.56 10.09 27 663878 7205 79073278
Hypopituitarism 11.52 10.09 7 663898 3392 79077091
Rash morbilliform 11.49 10.09 21 663884 6129 79074354
Epidural lipomatosis 11.46 10.09 29 663876 1199 79079284
Aphthous ulcer 11.43 10.09 201 663704 16688 79063795
Anal fissure 11.40 10.09 106 663799 7597 79072886
Plantar fasciitis 11.40 10.09 58 663847 3402 79077081
Eyelid oedema 11.37 10.09 67 663838 13620 79066863
Wrong patient received product 11.35 10.09 13 663892 4605 79075878
Hyperreflexia 11.35 10.09 34 663871 8351 79072132
Troponin increased 11.31 10.09 104 663801 19151 79061332
Full blood count decreased 11.31 10.09 298 663607 26521 79053962
Pseudomembranous colitis 11.29 10.09 17 663888 5357 79075126
Hepatic siderosis 11.28 10.09 10 663895 154 79080329
Autoimmune hepatitis 11.28 10.09 55 663850 11728 79068755
Motor dysfunction 11.27 10.09 74 663831 14659 79065824
Hypotonia 11.23 10.09 62 663843 12808 79067675
Labyrinthitis 11.21 10.09 51 663854 2857 79077626
Pallor 11.20 10.09 324 663581 49738 79030745
Neck pain 11.19 10.09 750 663155 74667 79005816
Peritoneal dialysis complication 11.18 10.09 44 663861 2310 79078173
Cardiopulmonary failure 11.18 10.09 25 663880 6776 79073707
Lip and/or oral cavity cancer 11.14 10.09 27 663878 1086 79079397
Tuberculin test positive 11.14 10.09 57 663848 3351 79077132
Hepatosplenomegaly 11.09 10.09 21 663884 6048 79074435
Lung hernia 11.08 10.09 7 663898 62 79080421
Vascular rupture 11.03 10.09 35 663870 1650 79078833
Corneal oedema 11.03 10.09 4 663901 2616 79077867
Low turnover osteopathy 11.00 10.09 39 663866 1947 79078536
Emotional distress 10.99 10.09 251 663654 39718 79040765
Stress 10.98 10.09 787 663118 78825 79001658
Uterine contractions during pregnancy 10.98 10.09 16 663889 434 79080049
Immune thrombocytopenia 10.97 10.09 95 663810 17710 79062773
Bradyarrhythmia 10.94 10.09 11 663894 4135 79076348
Ventricular hypokinesia 10.93 10.09 40 663865 9239 79071244
Oxygen saturation decreased 10.92 10.09 1231 662674 127816 78952667
Skin abrasion 10.92 10.09 165 663740 13291 79067192
Viral infection 10.90 10.09 450 663455 42566 79037917
Lymphatic fistula 10.89 10.09 22 663883 781 79079702
Dry throat 10.89 10.09 105 663800 7601 79072882
Threatened labour 10.83 10.09 19 663886 605 79079878
Magnesium deficiency 10.83 10.09 19 663886 605 79079878
Product prescribing error 10.80 10.09 287 663618 44526 79035957
Cryptococcosis 10.76 10.09 8 663897 3485 79076998
Systemic candida 10.75 10.09 25 663880 6681 79073802
Rotator cuff syndrome 10.74 10.09 171 663734 13924 79066559
Dyslipidaemia 10.73 10.09 55 663850 11578 79068905
Diplopia 10.72 10.09 205 663700 33261 79047222
Prerenal failure 10.72 10.09 9 663896 3689 79076794
Angina unstable 10.72 10.09 87 663818 16440 79064043
Vitamin D decreased 10.69 10.09 126 663779 9599 79070884
Intraocular pressure increased 10.63 10.09 40 663865 9165 79071318
Clear cell renal cell carcinoma 10.55 10.09 46 663859 2530 79077953
Pneumothorax 10.51 10.09 169 663736 28154 79052329
Walking aid user 10.51 10.09 130 663775 10018 79070465
Poor quality device used 10.48 10.09 3 663902 2282 79078201
Defaecation disorder 10.47 10.09 20 663885 681 79079802
Immune-mediated enterocolitis 10.42 10.09 15 663890 4815 79075668
Appendicolith 10.40 10.09 113 663792 8438 79072045
Skin texture abnormal 10.40 10.09 16 663889 456 79080027
Spinal fusion surgery 10.39 10.09 77 663828 5161 79075322
Varicella zoster virus infection 10.39 10.09 13 663892 4428 79076055
Skin plaque 10.37 10.09 50 663855 10695 79069788
Autonomic nervous system imbalance 10.37 10.09 14 663891 4616 79075867
Dactylitis 10.37 10.09 48 663857 2709 79077774
Acute respiratory failure 10.34 10.09 398 663507 59143 79021340
Upper respiratory tract inflammation 10.31 10.09 11 663894 4024 79076459
Candida sepsis 10.30 10.09 4 663901 2509 79077974
Small for dates baby 10.29 10.09 16 663889 460 79080023
Lip blister 10.28 10.09 48 663857 2719 79077764
Laryngeal oedema 10.27 10.09 34 663871 8095 79072388
Iodine allergy 10.27 10.09 18 663887 573 79079910
Human anti-human antibody test 10.26 10.09 15 663890 408 79080075
Bone cyst 10.25 10.09 56 663849 3377 79077106
Renal tubular acidosis 10.23 10.09 9 663896 3605 79076878
Drug hypersensitivity 10.21 10.09 2267 661638 296649 78783834
Abortion threatened 10.20 10.09 15 663890 410 79080073
Oesophageal fibrosis 10.20 10.09 10 663895 176 79080307
Insomnia 10.18 10.09 2248 661657 242922 78837561
Vein disorder 10.18 10.09 76 663829 5106 79075377
Femoral hernia incarcerated 10.17 10.09 22 663883 820 79079663
Liver abscess 10.17 10.09 22 663883 6032 79074451
Breast abscess 10.10 10.09 31 663874 1435 79079048
Escherichia bacteraemia 10.09 10.09 25 663880 6537 79073946

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11GA01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), plain
ATC A11GB01 ALIMENTARY TRACT AND METABOLISM
VITAMINS
ASCORBIC ACID (VITAMIN C), INCL. COMBINATIONS
Ascorbic acid (vitamin C), combinations
ATC G01AD03 GENITO URINARY SYSTEM AND SEX HORMONES
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
Organic acids
ATC S01XA15 SENSORY ORGANS
OPHTHALMOLOGICALS
OTHER OPHTHALMOLOGICALS
Other ophthalmologicals
FDA CS M0001797 Ascorbic Acid
MeSH PA D000975 Antioxidants
MeSH PA D018977 Micronutrients
MeSH PA D020011 Protective Agents
MeSH PA D014815 Vitamins
FDA EPC N0000193618 Vitamin C
CHEBI has role CHEBI:23354 coenzymes
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:64577 dough improvers
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:77962 food antioxidants
CHEBI has role CHEBI:85046 skin lightening agents
CHEBI has role CHEBI:176497 geroprotectors
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:83056 Daphnia magna metabolites
CHEBI has role CHEBI:63247 reducer
CHEBI has role CHEBI:27314 water-soluble vitamins

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

DiseaseRelationSNOMED_IDDOID
Ascorbic acid deficiency indication 76169001
Breastfeeding (mother) indication 413712001
Coronavirus infection off-label use 186747009
Anuria contraindication 2472002 DOID:2983
Hypocalcemia contraindication 5291005
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Severe chronic ulcerative colitis contraindication 14311001
Constipation contraindication 14760008 DOID:2089
Operation on stomach contraindication 16453004
Primary hyperoxaluria contraindication 17901006 DOID:2977
Hypocupremia contraindication 19577007
Hyperphosphatemia contraindication 20165001 DOID:0050459
Sunburn contraindication 23346002
Acute vomiting contraindication 23971007
Multiple sclerosis contraindication 24700007 DOID:2377
Gastroenteritis contraindication 25374005 DOID:2326
Acute tuberculosis contraindication 25629007
Hypervitaminosis D contraindication 27712000 DOID:9971
Complete atrioventricular block contraindication 27885002
Toxic megacolon contraindication 28536002 DOID:1770
Dental fluorosis contraindication 30265004
Sarcoidosis contraindication 31541009 DOID:11335
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Hemosiderosis contraindication 39011001 DOID:12119
Gastrointestinal ulcer contraindication 40845000
Toxic colitis contraindication 42359007
Hypokalemia contraindication 43339004
Gastrointestinal perforation contraindication 51875005
Gastrectomy contraindication 53442002
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Hyperlipidemia contraindication 55822004 DOID:1168
Congenital myotonia, autosomal dominant form contraindication 57938005
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Hemolytic anemia contraindication 61261009 DOID:583
Allergic rhinitis contraindication 61582004
Hypervitaminosis A contraindication 64559002 DOID:9972
Ulcerative colitis contraindication 64766004 DOID:8577
Blood coagulation disorder contraindication 64779008 DOID:1247
Hypercalcemia contraindication 66931009 DOID:12678
Hyperparathyroidism contraindication 66999008 DOID:13543
Rheumatoid arthritis contraindication 69896004 DOID:7148
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperchloremia contraindication 74450001
Third degree burn injury contraindication 80247002
Intestinal obstruction contraindication 81060008 DOID:8437
Atrophic gastritis contraindication 84568007 DOID:8929
Human immunodeficiency virus infection contraindication 86406008 DOID:526
Wilson's disease contraindication 88518009
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Leukemia, disease contraindication 93143009 DOID:1240
Kidney stone contraindication 95570007
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Hb SS disease contraindication 127040003 DOID:10923
Seizure disorder contraindication 128613002
Osteolysis contraindication 203522001
Disease of liver contraindication 235856003 DOID:409
Hyporeninemic hypoaldosteronism contraindication 236464008
Esophageal dysmotility contraindication 266434009 DOID:9192
Familial hyperkalemic periodic paralysis contraindication 304737009 DOID:14451
Gastric retention contraindication 307227006
Arteriosclerosis obliterans contraindication 361133006 DOID:5160
At risk for aspiration contraindication 371736008
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Denuded skin contraindication 418242004
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006
Vitamin K Deficiency Induced Hypoprothrombinemia contraindication
Malabsorption States contraindication
Repeated Blood Transfusions contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.02 acidic
pKa2 9.62 acidic
pKa3 11.85 acidic
pKa4 12.53 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10792306 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 11529368 March 9, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9592252 Aug. 11, 2032 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 10918723 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM PLENVU SALIX N209381 May 4, 2018 RX FOR SOLUTION ORAL 9326969 Sept. 10, 2033 FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25,000MG/50ML (500MG/ML) ASCOR MCGUFF N209112 Oct. 2, 2017 RX SOLUTION INTRAVENOUS Oct. 2, 2024 FOR TREATMENT OF SCURVY IN ADULT AND PEDIATRIC PATIENTS AGE 5 MONTHS AND OLDER FOR WHOM ORAL ADMINISTRATION IS NOT POSSIBLE, INSUFFICIENT OR CONTRAINDICATED

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Tyrosinase Enzyme IC50 4.49 CHEMBL
Prolyl 4-hydroxylase subunit alpha-1 Enzyme WOMBAT-PK
Procollagen-lysine,2-oxoglutarate 5-dioxygenase 1 Enzyme WOMBAT-PK
Solute carrier family 23 member 2 Transporter WOMBAT-PK
Solute carrier family 23 member 1 Transporter WOMBAT-PK
Urease Enzyme IC50 5.07 CHEMBL
Pancreatic alpha-amylase Enzyme IC50 4.58 CHEMBL

External reference:

IDSource
4017646 VUID
N0000146025 NUI
D00018 KEGG_DRUG
134-03-2 SECONDARY_CAS_RN
5743-28-2 SECONDARY_CAS_RN
4017471 VANDF
4017472 VANDF
4017646 VANDF
4021716 VANDF
4026966 VANDF
C0003968 UMLSCUI
CHEBI:29073 CHEBI
ASC PDB_CHEM_ID
CHEMBL196 ChEMBL_ID
CHEMBL591665 ChEMBL_ID
CHEMBL2146095 ChEMBL_ID
D001205 MESH_DESCRIPTOR_UI
DB00126 DRUGBANK_ID
C069207 MESH_SUPPLEMENTAL_RECORD_UI
4781 IUPHAR_LIGAND_ID
372 INN_ID
PQ6CK8PD0R UNII
54670067 PUBCHEM_CID
DB14482 DRUGBANK_ID
DB14483 DRUGBANK_ID
1151 RXNORM
1132 MMSL
11881 MMSL
32646 MMSL
4221 MMSL
5471 MMSL
5687 MMSL
6032 MMSL
72299 MMSL
NOCODE MMSL
d00426 MMSL
001010 NDDF
001011 NDDF
001012 NDDF
126230002 SNOMEDCT_US
126231003 SNOMEDCT_US
43706004 SNOMEDCT_US
46123006 SNOMEDCT_US
174 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 120 mg ORAL unapproved drug other 17 sections
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 120 mg ORAL unapproved drug other 17 sections
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 120 mg ORAL Unapproved drug other 12 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 15 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 15 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 138 mg ORAL unapproved drug other 15 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 120 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 120 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN OTC DRUG LABEL 14 0178-0829 TABLET 120 mg ORAL Unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 13 0178-0858 TABLET 120 mg ORAL Unapproved drug other 12 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 14 0178-0859 TABLET 120 mg ORAL Unapproved drug other 9 sections
CitraNatal DHA HUMAN OTC DRUG LABEL 14 0178-0898 TABLET 120 mg ORAL Unapproved drug other 11 sections
Antiflu Kids HUMAN OTC DRUG LABEL 3 0280-0046 POWDER, FOR SOLUTION 50 mg ORAL Export only 2 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 30 mg ORAL unapproved drug other 14 sections
Vitafol Caplet HUMAN PRESCRIPTION DRUG LABEL 12 0642-0072 CAPSULE 60 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 70 mg ORAL Unapproved drug other 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 70 mg ORAL Unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 12 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 30 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 30 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 60 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Strovite Forte Caplet HUMAN PRESCRIPTION DRUG LABEL 19 0642-0204 TABLET, COATED 500 mg ORAL UNAPPROVED DRUG OTHER 15 sections
Strovite One Caplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 300 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Strovite One Caplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 300 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Reaphirm Plant Source DHA HUMAN PRESCRIPTION DRUG LABEL 16 0642-3010 CAPSULE, GELATIN COATED 30 mg ORAL unapproved drug other 7 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 60 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Marnatal F HUMAN PRESCRIPTION DRUG LABEL 13 0682-1570 CAPSULE 100 mg ORAL UNAPPROVED DRUG OTHER 4 sections
BACMIN HUMAN PRESCRIPTION DRUG LABEL 19 0682-3001 TABLET, COATED 500 mg ORAL UNAPPROVED DRUG OTHER 10 sections