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

Stem definitionDrug idCAS RN
1552 75706-12-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • leflunomide medac
  • leflunomide
  • arava
  • avara
  • leflunomida
  • leflunomidum
  • lefumide
  • repso
An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
  • Molecular weight: 270.21
  • Formula: C12H9F3N2O2
  • CLOGP: 2.36
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 55.13
  • ALOGS: -3.51
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.23 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 10, 1998 FDA SANOFI AVENTIS US

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
Drug ineffective 7285.06 13.44 16094 310672 803239 49475119
Drug intolerance 4864.53 13.44 6499 320267 212605 50065753
Rheumatoid arthritis 4126.76 13.44 5766 321000 196784 50081574
Contraindicated product administered 3907.10 13.44 4804 321962 144154 50134204
Joint swelling 3569.10 13.44 5973 320793 239313 50039045
Treatment failure 2837.72 13.44 3945 322821 133692 50144666
Synovitis 2665.29 13.44 3625 323141 120240 50158118
Arthropathy 2286.52 13.44 3842 322924 154064 50124294
Therapeutic product effect decreased 2229.92 13.44 3502 323264 132548 50145810
Pemphigus 1957.17 13.44 3085 323681 117081 50161277
Systemic lupus erythematosus 1810.67 13.44 3250 323516 137372 50140986
Abdominal discomfort 1769.97 13.44 4320 322446 227321 50051037
Swelling 1715.34 13.44 3913 322853 196959 50081399
Hand deformity 1571.05 13.44 2529 324237 97670 50180688
Alopecia 1549.40 13.44 4257 322509 240790 50037568
Glossodynia 1547.49 13.44 2718 324048 112851 50165507
Pain 1455.05 13.44 7461 319305 571442 49706916
Death 1294.62 13.44 264 326502 325115 49953243
Arthralgia 1173.80 13.44 5760 321006 432942 49845416
Hepatic enzyme increased 1150.76 13.44 2658 324108 134722 50143636
Therapeutic product effect incomplete 1018.96 13.44 1989 324777 89526 50188832
Anti-cyclic citrullinated peptide antibody positive 1006.54 13.44 1708 325058 68879 50209479
Peripheral swelling 965.64 13.44 3223 323543 202713 50075645
Rheumatoid factor positive 944.90 13.44 1375 325391 48484 50229874
Wound 909.81 13.44 2069 324697 103725 50174633
Drug hypersensitivity 901.28 13.44 3602 323164 247408 50030950
Hypersensitivity 878.55 13.44 3217 323549 211944 50066414
C-reactive protein abnormal 870.42 13.44 984 325782 26825 50251533
Rash 851.00 13.44 5271 321495 432200 49846158
Acute kidney injury 834.86 13.44 221 326545 227837 50050521
Musculoskeletal stiffness 815.59 13.44 2238 324528 126243 50152115
Hypotension 814.41 13.44 254 326512 235215 50043143
Pericarditis 778.87 13.44 1629 325137 77060 50201298
Completed suicide 761.44 13.44 19 326747 131870 50146488
Toxicity to various agents 719.18 13.44 238 326528 212261 50066097
Infection 687.81 13.44 2565 324201 170389 50107969
Discomfort 679.77 13.44 1880 324886 106500 50171858
Constipation 671.83 13.44 184 326582 185524 50092834
Gastrointestinal disorder 660.52 13.44 1706 325060 92750 50185608
Folliculitis 648.13 13.44 1015 325751 38210 50240148
Muscle injury 644.99 13.44 983 325783 36128 50242230
Drug interaction 637.21 13.44 246 326520 199375 50078983
Lower respiratory tract infection 633.58 13.44 1688 325078 93513 50184845
Loss of personal independence in daily activities 611.83 13.44 1379 325387 68671 50209687
Red blood cell sedimentation rate abnormal 599.80 13.44 629 326137 15714 50262644
Anaemia 588.99 13.44 461 326305 251995 50026363
Irritable bowel syndrome 585.42 13.44 1129 325637 50312 50228046
Impaired healing 575.45 13.44 1343 325423 68443 50209915
Condition aggravated 568.18 13.44 3567 323199 293491 49984867
Infusion related reaction 550.66 13.44 2361 324405 167196 50111162
Product use issue 532.86 13.44 2142 324624 147333 50131025
Dehydration 529.31 13.44 163 326603 152286 50126072
Febrile neutropenia 522.31 13.44 26 326740 97641 50180717
Ill-defined disorder 519.19 13.44 1113 325653 53541 50224817
Helicobacter infection 479.97 13.44 1019 325747 48683 50229675
Red blood cell sedimentation rate increased 477.32 13.44 755 326011 28661 50249697
Tremor 471.28 13.44 86 326680 114817 50163541
Psoriatic arthropathy 467.81 13.44 976 325790 46056 50232302
Duodenal ulcer perforation 457.74 13.44 950 325816 44661 50233697
Maternal exposure during pregnancy 454.18 13.44 2139 324627 157639 50120719
Hyponatraemia 452.99 13.44 47 326719 96092 50182266
Sleep disorder due to general medical condition, insomnia type 449.25 13.44 762 326004 30685 50247673
Seizure 448.80 13.44 105 326661 117769 50160589
Dizziness 442.93 13.44 989 325777 345380 49932978
Anxiety 435.00 13.44 308 326458 177298 50101060
Overdose 423.59 13.44 68 326698 99659 50178699
Bone erosion 418.51 13.44 444 326322 11243 50267115
Blister 410.94 13.44 1350 325416 84068 50194290
C-reactive protein increased 401.58 13.44 1138 325628 65336 50213022
Somnolence 391.17 13.44 260 326506 154725 50123633
Product dose omission issue 390.29 13.44 367 326399 183471 50094887
Cardiac arrest 373.92 13.44 49 326717 83602 50194756
Fall 371.37 13.44 1029 325737 333903 49944455
Knee arthroplasty 370.70 13.44 756 326010 35090 50243268
Intentional overdose 368.46 13.44 7 326759 62497 50215861
Rheumatoid nodule 365.40 13.44 431 326335 12304 50266054
Dyspnoea 364.73 13.44 2063 324703 545545 49732813
Bradycardia 354.77 13.44 14 326752 64412 50213946
Urinary tract infection 330.35 13.44 588 326178 223432 50054926
Thrombocytopenia 325.07 13.44 212 326554 127461 50150897
Disease progression 317.65 13.44 111 326655 95755 50182603
Oedema peripheral 313.83 13.44 334 326432 157627 50120731
Hypokalaemia 312.69 13.44 90 326676 87902 50190456
Mobility decreased 309.11 13.44 1176 325590 78772 50199586
Blood iron abnormal 308.76 13.44 218 326548 3108 50275250
Electrocardiogram QT prolonged 297.32 13.44 8 326758 51878 50226480
Abdominal pain 296.28 13.44 681 326085 235547 50042811
Hip arthroplasty 293.84 13.44 624 326142 29805 50248553
Sinusitis 291.06 13.44 1992 324774 168566 50109792
Neutropenia 284.93 13.44 321 326445 147644 50130714
Tachycardia 280.37 13.44 147 326619 99616 50178742
Sepsis 267.43 13.44 278 326488 132647 50145711
Muscle spasms 263.57 13.44 253 326513 125300 50153058
Chest discomfort 261.48 13.44 136 326630 92586 50185772
Stomatitis 257.78 13.44 1315 325451 100029 50178329
Cardio-respiratory arrest 252.13 13.44 27 326739 53865 50224493
Depressed level of consciousness 248.32 13.44 24 326742 51929 50226429
Suicide attempt 246.99 13.44 24 326742 51708 50226650
Atrial fibrillation 242.99 13.44 181 326585 101564 50176794
Vision blurred 239.17 13.44 104 326662 78543 50199815
Hyperkalaemia 238.57 13.44 19 326747 48070 50230288
Chest pain 237.29 13.44 491 326275 176391 50101967
Platelet count decreased 235.68 13.44 183 326583 100543 50177815
Foot deformity 232.49 13.44 433 326333 18777 50259581
Osteoporosis 231.75 13.44 727 326039 44152 50234206
Balance disorder 231.66 13.44 83 326683 70507 50207851
Haemoglobin decreased 229.94 13.44 290 326476 126926 50151432
Asthenia 229.39 13.44 1170 325596 317872 49960486
Agitation 225.28 13.44 37 326729 53347 50225011
Pulmonary embolism 221.64 13.44 198 326568 101506 50176852
Osteoarthritis 220.44 13.44 953 325813 67653 50210705
Hypoglycaemia 219.83 13.44 40 326726 53541 50224817
Respiratory failure 219.29 13.44 161 326605 91020 50187338
Musculoskeletal disorder 216.17 13.44 396 326370 16953 50261405
Cardiac failure congestive 214.87 13.44 140 326626 84242 50194116
Epistaxis 210.20 13.44 75 326691 63879 50214479
Granuloma skin 208.24 13.44 221 326545 5597 50272761
Cerebrovascular accident 207.91 13.44 183 326583 94497 50183861
Disability 204.58 13.44 326 326440 12449 50265909
Hallucination 202.18 13.44 30 326736 46627 50231731
Panniculitis 200.85 13.44 261 326505 8242 50270116
Syncope 199.81 13.44 222 326544 102780 50175578
Blood parathyroid hormone decreased 199.51 13.44 238 326528 6876 50271482
Tenosynovitis 199.42 13.44 291 326475 10274 50268084
Blood glucose increased 199.03 13.44 106 326660 71218 50207140
Deformity 195.84 13.44 249 326517 7691 50270667
Gastrointestinal haemorrhage 194.49 13.44 116 326650 73205 50205153
Neutrophil count decreased 191.77 13.44 33 326733 45993 50232365
Drug tolerance decreased 190.13 13.44 264 326502 8896 50269462
Inflammation 189.33 13.44 799 325967 56113 50222245
Metabolic acidosis 188.04 13.44 17 326749 38808 50239550
Arthritis 185.18 13.44 1073 325693 85648 50192710
Wrong technique in product usage process 184.31 13.44 64 326702 55446 50222912
Sedation 182.15 13.44 3 326763 30607 50247751
Hypoxia 182.12 13.44 52 326714 51071 50227287
Decreased appetite 181.94 13.44 675 326091 200248 50078110
Myalgia 181.53 13.44 328 326438 123991 50154367
Blood cholesterol increased 181.21 13.44 772 325994 54443 50223915
Cognitive disorder 180.87 13.44 33 326733 44090 50234268
Swollen joint count increased 178.42 13.44 334 326432 14539 50263819
Unresponsive to stimuli 178.10 13.44 4 326762 30605 50247753
Pancytopenia 176.68 13.44 169 326597 83861 50194497
Lactic acidosis 174.75 13.44 10 326756 33345 50245013
Renal failure 174.64 13.44 261 326505 106372 50171986
Deafness transitory 174.37 13.44 121 326645 1675 50276683
Rheumatic fever 173.46 13.44 355 326411 16512 50261846
Cardiac failure 171.78 13.44 143 326623 75897 50202461
Vomiting 171.72 13.44 2027 324739 458731 49819627
Finger deformity 170.83 13.44 197 326569 5485 50272873
Therapeutic response decreased 170.45 13.44 680 326086 46551 50231807
Liver function test increased 170.05 13.44 454 326312 25152 50253206
Joint range of motion decreased 167.69 13.44 370 326396 18142 50260216
International normalised ratio increased 167.03 13.44 37 326729 43115 50235243
White blood cell count decreased 165.93 13.44 313 326453 116409 50161949
Mental status changes 165.08 13.44 20 326746 36252 50242106
Joint stiffness 164.85 13.44 500 326266 29808 50248550
Coma 163.96 13.44 81 326685 56798 50221560
Pneumonia aspiration 163.34 13.44 9 326757 30995 50247363
Pulmonary oedema 163.20 13.44 56 326710 48882 50229476
Plasma cell myeloma 162.24 13.44 10 326756 31312 50247046
Depression 161.62 13.44 538 326228 164885 50113473
Flushing 161.55 13.44 118 326648 66897 50211461
Hyperhidrosis 161.39 13.44 204 326562 89222 50189136
Hyperglycaemia 161.03 13.44 22 326744 36383 50241975
Pleural effusion 159.68 13.44 174 326592 81280 50197078
Pulmonary fibrosis 158.98 13.44 430 326336 24007 50254351
Lethargy 157.34 13.44 61 326705 49371 50228987
Respiratory arrest 157.20 13.44 9 326757 30000 50248358
Cough 157.13 13.44 914 325852 240350 50038008
Bone pain 155.85 13.44 55 326711 47174 50231184
Feeling abnormal 155.33 13.44 364 326402 125128 50153230
Gastrooesophageal reflux disease 154.59 13.44 159 326607 76269 50202089
Skin ulcer 151.10 13.44 537 326229 34781 50243577
Dysphagia 150.40 13.44 167 326599 77351 50201007
Blood pressure decreased 148.91 13.44 88 326678 55821 50222537
Adverse drug reaction 148.40 13.44 728 326038 54494 50223864
Chills 146.66 13.44 249 326517 96438 50181920
Rhabdomyolysis 144.09 13.44 37 326729 38990 50239368
Asthma 143.06 13.44 222 326544 89115 50189243
Fluid retention 141.70 13.44 75 326691 50574 50227784
Limb deformity 141.07 13.44 146 326620 3588 50274770
Product quality issue 140.46 13.44 17 326749 30841 50247517
Nasopharyngitis 140.05 13.44 1880 324886 191047 50087311
Nausea 139.97 13.44 3480 323286 701918 49576440
Encephalopathy 138.63 13.44 25 326741 33686 50244672
Skin necrosis 135.32 13.44 248 326518 10619 50267739
Disturbance in attention 135.24 13.44 20 326746 31166 50247192
Musculoskeletal deformity 134.55 13.44 82 326684 896 50277462
Intentional self-injury 134.55 13.44 3 326763 23109 50255249
Deep vein thrombosis 133.54 13.44 166 326600 73138 50205220
Drug withdrawal syndrome 133.00 13.44 7 326759 25074 50253284
Grip strength decreased 131.66 13.44 261 326505 11860 50266498
Thrombosis 131.11 13.44 101 326665 55732 50222626
Muscle spasticity 131.02 13.44 321 326445 16863 50261495
Hospitalisation 130.00 13.44 148 326618 67789 50210569
Dysarthria 127.87 13.44 41 326725 37362 50240996
Restlessness 127.54 13.44 9 326757 25164 50253194
Ascites 126.76 13.44 37 326729 35824 50242534
Neuropathy peripheral 125.94 13.44 273 326493 96484 50181874
Rheumatoid lung 124.41 13.44 113 326653 2352 50276006
Hypervolaemia 123.92 13.44 11 326755 25488 50252870
Orthostatic hypotension 123.12 13.44 21 326745 29460 50248898
Disorientation 122.91 13.44 38 326728 35446 50242912
Paraesthesia 122.31 13.44 384 326382 119859 50158499
Ear pain 121.80 13.44 431 326335 27852 50250506
Pyrexia 119.96 13.44 1731 325035 378472 49899886
Intentional product misuse 118.32 13.44 78 326688 46656 50231702
Oxygen saturation decreased 118.25 13.44 181 326585 73067 50205291
Pneumonia 117.91 13.44 1727 325039 376674 49901684
Urinary retention 117.81 13.44 15 326751 26175 50252183
Fatigue 116.78 13.44 5632 321134 701969 49576389
Diarrhoea 116.57 13.44 2903 323863 585573 49692785
Full blood count decreased 116.14 13.44 7 326759 22339 50256019
Adverse reaction 115.95 13.44 203 326563 8383 50269975
Urinary incontinence 115.82 13.44 21 326745 28187 50250171
Premature delivery 115.56 13.44 10 326756 23653 50254705
Rectal haemorrhage 114.04 13.44 53 326713 38505 50239853
Impaired work ability 113.93 13.44 264 326502 13376 50264982
Dyskinesia 113.84 13.44 21 326745 27840 50250518
Fibromyalgia 113.81 13.44 583 326183 44395 50233963
COVID-19 112.66 13.44 82 326684 46580 50231778
Adverse event 112.66 13.44 570 326196 43193 50235165
Cerebral haemorrhage 111.37 13.44 20 326746 27032 50251326
Chronic kidney disease 111.09 13.44 59 326707 39712 50238646
Altered state of consciousness 110.52 13.44 8 326758 21902 50256456
Blood potassium decreased 110.49 13.44 50 326716 36895 50241463
Respiratory distress 110.48 13.44 30 326736 30459 50247899
Body temperature increased 108.89 13.44 446 326320 30895 50247463
Haemorrhage 108.26 13.44 111 326655 53330 50225028
Melaena 106.07 13.44 22 326744 26842 50251516
Gastrointestinal pain 105.60 13.44 188 326578 7868 50270490
Haematoma 105.09 13.44 33 326733 30477 50247881
Generalised tonic-clonic seizure 105.02 13.44 21 326745 26289 50252069
Chronic obstructive pulmonary disease 104.87 13.44 114 326652 53321 50225037
Hypomagnesaemia 104.80 13.44 13 326753 23143 50255215
Suicidal ideation 104.51 13.44 122 326644 55263 50223095
Shoulder arthroplasty 104.42 13.44 120 326646 3328 50275030
Dysgeusia 103.98 13.44 61 326705 38855 50239503
Lymphocyte count decreased 102.94 13.44 22 326744 26285 50252073
Dry skin 102.85 13.44 77 326689 43114 50235244
Ankylosing spondylitis 102.78 13.44 174 326592 6991 50271367
Abnormal behaviour 102.65 13.44 6 326760 19652 50258706
Oral mucosal exfoliation 102.17 13.44 83 326683 1476 50276882
Multiple organ dysfunction syndrome 101.46 13.44 105 326661 50232 50228126
Foot operation 100.00 13.44 149 326617 5361 50272997
Nodule 99.58 13.44 288 326478 16715 50261643
Pulmonary toxicity 98.93 13.44 149 326617 5413 50272945
Blood creatinine increased 98.18 13.44 216 326550 75944 50202414
Cardiac disorder 98.07 13.44 80 326686 42899 50235459
Sleep disorder 98.06 13.44 670 326096 56613 50221745
Epilepsy 97.87 13.44 12 326754 21555 50256803
Aphasia 97.82 13.44 31 326735 28463 50249895
Drug level increased 97.29 13.44 7 326759 19261 50259097
Night sweats 96.25 13.44 451 326315 33123 50245235
Memory impairment 95.92 13.44 233 326533 79127 50199231
Incorrect dose administered 95.33 13.44 103 326663 48311 50230047
Aggression 95.21 13.44 12 326754 21104 50257254
Presyncope 95.16 13.44 20 326746 24178 50254180
Breast cancer stage III 94.72 13.44 111 326655 3145 50275213
Depressed mood 94.26 13.44 51 326715 33972 50244386
Metastases to liver 94.20 13.44 10 326756 20094 50258264
Joint destruction 93.73 13.44 121 326645 3795 50274563
Erythema 93.43 13.44 558 326208 145856 50132502
Device dislocation 93.00 13.44 14 326752 21532 50256826
Retinal toxicity 92.45 13.44 70 326696 1118 50277240
Palpitations 91.10 13.44 309 326457 94197 50184161
Flatulence 91.05 13.44 38 326728 29420 50248938
Enthesopathy 90.63 13.44 165 326601 7028 50271330
Irritability 90.59 13.44 35 326731 28391 50249967
Tuberculin test positive 90.01 13.44 107 326659 3079 50275279
Physical disability 89.96 13.44 83 326683 1764 50276594
Drug eruption 89.30 13.44 345 326421 23261 50255097
Joint laxity 89.22 13.44 93 326673 2305 50276053
Right ventricular failure 89.04 13.44 3 326763 15890 50262468
Injection site pain 89.03 13.44 391 326375 110633 50167725
Drug reaction with eosinophilia and systemic symptoms 88.93 13.44 36 326730 28388 50249970
Sciatica 88.79 13.44 322 326444 21060 50257298
Blood calcium decreased 88.13 13.44 14 326752 20692 50257666
Psychotic disorder 87.92 13.44 17 326749 21795 50256563
Heart rate increased 87.81 13.44 234 326532 77016 50201342
Red blood cell sedimentation rate 87.71 13.44 112 326654 3474 50274884
Hypocalcaemia 87.16 13.44 32 326734 26784 50251574
Metastases to bone 86.81 13.44 8 326758 17987 50260371
Arthrodesis 86.47 13.44 93 326673 2392 50275966
Dyspnoea exertional 86.19 13.44 123 326643 51110 50227248
Spinal column injury 85.88 13.44 80 326686 1722 50276636
Dysuria 84.57 13.44 39 326727 28465 50249893
Rheumatoid factor negative 84.33 13.44 51 326715 549 50277809
Pulmonary hypertension 84.28 13.44 56 326710 33361 50244997
Vaginal haemorrhage 83.76 13.44 27 326739 24524 50253834
Ejection fraction decreased 82.36 13.44 11 326755 18509 50259849
Inappropriate schedule of product administration 82.08 13.44 217 326549 71614 50206744
Withdrawal syndrome 81.78 13.44 9 326757 17581 50260777
Eye pain 81.24 13.44 41 326725 28408 50249950
Hallucination, visual 81.00 13.44 7 326759 16575 50261783
Septic shock 80.61 13.44 154 326612 57021 50221337
Haematochezia 80.59 13.44 83 326683 39799 50238559
Panic attack 80.28 13.44 14 326752 19328 50259030
Sleep apnoea syndrome 80.11 13.44 27 326739 23841 50254517
Abdominal pain lower 79.59 13.44 21 326745 21735 50256623
Respiratory disorder 79.41 13.44 405 326361 30782 50247576
X-ray abnormal 78.14 13.44 91 326675 2561 50275797
Neutropenic sepsis 78.11 13.44 3 326763 14144 50264214
Surgical failure 77.78 13.44 57 326709 864 50277494
Circulatory collapse 77.69 13.44 17 326749 19983 50258375
Foetal exposure during pregnancy 77.28 13.44 40 326726 27319 50251039
Vertigo 77.18 13.44 135 326631 51697 50226661
Accidental overdose 77.11 13.44 16 326750 19517 50258841
Blood urea increased 76.90 13.44 28 326738 23557 50254801
Arrhythmia 76.43 13.44 61 326705 33071 50245287
Transient ischaemic attack 75.95 13.44 58 326708 32152 50246206
Bone marrow failure 75.66 13.44 42 326724 27582 50250776
Acute respiratory failure 75.65 13.44 46 326720 28736 50249622
Neurotoxicity 75.46 13.44 5 326761 14735 50263623
Ulcer 75.41 13.44 294 326472 19906 50258452
Blood creatine phosphokinase increased 75.29 13.44 38 326728 26329 50252029
Dementia 74.84 13.44 8 326758 15989 50262369
Pancreatitis acute 74.76 13.44 30 326736 23782 50254576
Diabetic ketoacidosis 74.03 13.44 13 326753 17859 50260499
Ventricular tachycardia 73.80 13.44 8 326758 15813 50262545
Colitis 73.62 13.44 84 326682 38445 50239913
Clostridium difficile colitis 73.29 13.44 13 326753 17729 50260629
Mucosal inflammation 72.99 13.44 91 326675 40051 50238307
Joint effusion 72.85 13.44 217 326549 12804 50265554
Upper gastrointestinal haemorrhage 72.57 13.44 9 326757 16026 50262332
Full blood count abnormal 72.56 13.44 30 326736 23358 50255000
Hemiparesis 72.12 13.44 20 326746 20028 50258330
Sinus bradycardia 72.10 13.44 3 326763 13180 50265178
Cholestasis 71.95 13.44 37 326729 25364 50252994
Sinus tachycardia 71.95 13.44 24 326742 21330 50257028
Oropharyngeal pain 71.87 13.44 259 326507 77542 50200816
Inappropriate antidiuretic hormone secretion 71.85 13.44 3 326763 13140 50265218
Underdose 71.52 13.44 21 326745 20257 50258101
Abdominal distension 71.19 13.44 237 326529 72666 50205692
Type 2 diabetes mellitus 71.16 13.44 422 326344 33953 50244405
Myocardial infarction 71.08 13.44 314 326452 88713 50189645
Toxic epidermal necrolysis 70.02 13.44 24 326742 20968 50257390
Pain in jaw 69.99 13.44 87 326679 38341 50240017
Acute myocardial infarction 69.94 13.44 52 326714 29221 50249137
Intentional product use issue 69.77 13.44 782 325984 76136 50202222
Face oedema 69.63 13.44 15 326751 17824 50260534
Therapy cessation 69.17 13.44 41 326725 25970 50252388
Wheezing 68.97 13.44 190 326576 61857 50216501
Haematuria 68.64 13.44 40 326726 25573 50252785
Product use in unapproved indication 68.40 13.44 452 326314 115367 50162991
Loose body in joint 68.40 13.44 59 326707 1144 50277214
Product administration error 68.39 13.44 21 326745 19678 50258680
Emotional distress 68.37 13.44 51 326715 28612 50249746
Myoclonus 68.31 13.44 7 326759 14463 50263895
Cerebral infarction 68.18 13.44 27 326739 21577 50256781
Seronegative arthritis 68.00 13.44 75 326691 1986 50276372
Pruritus allergic 67.91 13.44 57 326709 1063 50277295
Electrolyte imbalance 67.91 13.44 14 326752 17155 50261203
Muscular weakness 67.74 13.44 349 326417 94664 50183694
Rash erythematous 67.67 13.44 75 326691 34777 50243581
Blood sodium decreased 67.45 13.44 26 326740 21121 50257237
Pericardial effusion 67.11 13.44 41 326725 25548 50252810
Red cell distribution width decreased 66.52 13.44 56 326710 1049 50277309
Accidental exposure to product 66.18 13.44 33 326733 23024 50255334
Tuberculosis 66.15 13.44 178 326588 9905 50268453
Pollakiuria 65.71 13.44 36 326730 23815 50254543
Haemoptysis 65.65 13.44 42 326724 25531 50252827
Agranulocytosis 65.61 13.44 28 326738 21393 50256965
Vascular access complication 65.17 13.44 56 326710 1080 50277278
Poisoning 64.27 13.44 4 326762 12425 50265933
Basal cell carcinoma 64.22 13.44 310 326456 23046 50255312
Abortion spontaneous 63.84 13.44 107 326659 41665 50236693
Head injury 63.68 13.44 38 326728 23982 50254376
Product substitution issue 63.35 13.44 8 326758 14049 50264309
Delirium 62.95 13.44 93 326673 38099 50240259
Acute myeloid leukaemia 62.36 13.44 11 326755 15063 50263295
Muscle twitching 62.25 13.44 12 326754 15419 50262939
Cholelithiasis 62.07 13.44 93 326673 37880 50240478
Status epilepticus 61.97 13.44 7 326759 13399 50264959
Product prescribing error 61.69 13.44 29 326737 20932 50257426
Hepatic function abnormal 60.57 13.44 73 326693 32608 50245750
Skin exfoliation 60.28 13.44 77 326689 33535 50244823
Blood bilirubin increased 59.97 13.44 71 326695 31967 50246391
Disseminated intravascular coagulation 59.97 13.44 18 326748 17117 50261241
Angioedema 59.93 13.44 94 326672 37582 50240776
Device issue 59.76 13.44 27 326739 19945 50258413
Loss of consciousness 59.74 13.44 411 326355 103942 50174416
Dislocation of vertebra 59.67 13.44 86 326680 3001 50275357
Tinnitus 58.61 13.44 57 326709 28075 50250283
Burning sensation 58.47 13.44 129 326637 45317 50233041
Stevens-Johnson syndrome 58.24 13.44 34 326732 21718 50256640
Leukocytosis 58.08 13.44 37 326729 22542 50255816
Small intestinal obstruction 57.86 13.44 16 326750 16052 50262306
Drug ineffective for unapproved indication 57.36 13.44 33 326733 21248 50257110
Metastases to central nervous system 57.25 13.44 4 326762 11278 50267080
Renal impairment 56.75 13.44 273 326493 75388 50202970
Mental disorder 56.61 13.44 36 326730 21955 50256403
Transfusion 56.59 13.44 8 326758 12897 50265461
Lip swelling 56.48 13.44 46 326720 24690 50253668
Mean platelet volume decreased 56.34 13.44 61 326705 1581 50276777
Hypothermia 56.24 13.44 6 326760 12010 50266348
Diplopia 56.14 13.44 27 326739 19233 50259125
Coordination abnormal 55.98 13.44 5 326761 11529 50266829
Haemorrhage intracranial 55.87 13.44 7 326759 12367 50265991
Oedema 55.73 13.44 248 326518 69933 50208425
Dystonia 55.70 13.44 6 326760 11920 50266438
Demyelination 55.20 13.44 121 326645 5905 50272453
Mania 55.02 13.44 4 326762 10912 50267446
Ankle arthroplasty 54.93 13.44 51 326715 1093 50277265
Wrist deformity 54.85 13.44 63 326703 1746 50276612
Back injury 54.70 13.44 133 326633 6952 50271406
Paranoia 54.52 13.44 3 326763 10345 50268013
Pallor 54.41 13.44 42 326724 23157 50255201
Sensitivity to weather change 54.40 13.44 120 326646 5881 50272477
Fine motor skill dysfunction 54.10 13.44 96 326670 4007 50274351
Pulmonary arterial hypertension 54.07 13.44 32 326734 20287 50258071
Lacrimation increased 54.01 13.44 21 326745 16971 50261387
Cellulitis 53.95 13.44 254 326512 70544 50207814
Caesarean section 53.71 13.44 17 326749 15622 50262736
Renal disorder 53.61 13.44 59 326707 27446 50250912
Pneumonia viral 53.52 13.44 129 326637 6705 50271653
Swelling face 53.41 13.44 168 326598 52427 50225931
Coronary artery disease 53.41 13.44 68 326698 29658 50248700
Infusion site pain 53.34 13.44 8 326758 12338 50266020
Intestinal obstruction 53.20 13.44 55 326711 26328 50252030
Weight decreased 53.08 13.44 1058 325708 220187 50058171
Premature labour 53.03 13.44 6 326760 11470 50266888
Systemic lupus erythematosus rash 53.01 13.44 61 326705 1694 50276664
Product label confusion 52.70 13.44 36 326730 485 50277873
Speech disorder 52.55 13.44 93 326673 35455 50242903
Musculoskeletal pain 52.52 13.44 704 326062 71473 50206885
Bone swelling 52.49 13.44 51 326715 1159 50277199
Feeling hot 52.33 13.44 109 326657 39093 50239265
Incontinence 52.28 13.44 3 326763 9982 50268376
Hypersomnia 51.96 13.44 17 326749 15297 50263061
Pulmonary mass 51.95 13.44 249 326517 18456 50259902
Mean cell volume decreased 51.93 13.44 74 326692 2555 50275803
Therapy interrupted 51.86 13.44 33 326733 20119 50258239
Visual acuity reduced 51.80 13.44 33 326733 20106 50258252
Anuria 51.65 13.44 6 326760 11238 50267120
Ocular hyperaemia 51.18 13.44 34 326732 20258 50258100
Blood magnesium decreased 51.15 13.44 6 326760 11154 50267204
Infusion site reaction 50.99 13.44 67 326699 2139 50276219
Blood glucose decreased 50.88 13.44 27 326739 18184 50260174
Bacteraemia 50.81 13.44 15 326751 14418 50263940
Creatinine renal clearance decreased 50.64 13.44 8 326758 11873 50266485
Malaise 50.57 13.44 1717 325049 333815 49944543
Bone density abnormal 50.54 13.44 79 326687 2966 50275392
Renal tubular necrosis 50.47 13.44 4 326762 10164 50268194
Cholecystitis chronic 50.33 13.44 3 326763 9666 50268692
Subdural haematoma 50.30 13.44 11 326755 12936 50265422
Complication associated with device 50.20 13.44 16 326750 14639 50263719
Pharyngitis 50.07 13.44 235 326531 17268 50261090
Cardiogenic shock 50.04 13.44 19 326747 15580 50262778
Joint injury 50.02 13.44 275 326491 21514 50256844
Cutaneous vasculitis 49.89 13.44 96 326670 4266 50274092
Labelled drug-drug interaction medication error 49.63 13.44 5 326761 10472 50267886
Fear 49.63 13.44 16 326750 14533 50263825
Wrist surgery 49.19 13.44 41 326725 757 50277601
Respiratory depression 49.17 13.44 9 326757 12001 50266357
Bronchitis chronic 48.93 13.44 89 326677 3788 50274570
Gait disturbance 48.69 13.44 1291 325475 148714 50129644
Mitral valve incompetence 48.67 13.44 26 326740 17445 50260913
International normalised ratio fluctuation 48.29 13.44 65 326701 2125 50276233
Emotional disorder 48.18 13.44 9 326757 11827 50266531
Adjustment disorder with depressed mood 48.09 13.44 74 326692 2740 50275618
Mydriasis 48.01 13.44 6 326760 10621 50267737
Metastases to lung 47.93 13.44 7 326759 11013 50267345
Incorrect product administration duration 47.91 13.44 3 326763 9272 50269086
Nervousness 47.89 13.44 65 326701 27586 50250772
Multiple fractures 47.76 13.44 121 326645 6490 50271868
Malnutrition 47.74 13.44 13 326753 13176 50265182
Pancreatitis 47.72 13.44 130 326636 42484 50235874
Ear infection 47.59 13.44 309 326457 25661 50252697
Fear of injection 47.58 13.44 115 326651 5988 50272370
Diabetes mellitus inadequate control 47.50 13.44 13 326753 13132 50265226
Eosinophilia 47.38 13.44 31 326735 18621 50259737
Left ventricular dysfunction 47.29 13.44 6 326760 10500 50267858
Skin discolouration 47.25 13.44 87 326679 32670 50245688
Transaminases abnormal 47.18 13.44 35 326731 541 50277817
Dysphonia 47.13 13.44 114 326652 38778 50239580
Hot flush 47.06 13.44 138 326628 44031 50234327
Ischaemic stroke 47.03 13.44 22 326744 15926 50262432
Blood pressure increased 46.94 13.44 592 326174 132540 50145818
Therapeutic response unexpected 46.87 13.44 22 326744 15893 50262465
Gastric disorder 46.69 13.44 339 326427 29209 50249149
Tachypnoea 46.36 13.44 18 326748 14559 50263799
Gastritis 46.34 13.44 89 326677 32894 50245464
Peritonitis 46.23 13.44 21 326745 15465 50262893
Device difficult to use 46.11 13.44 5 326761 9881 50268477
Extrapyramidal disorder 45.73 13.44 10 326756 11760 50266598
Hepatotoxicity 45.72 13.44 317 326449 26909 50251449
Haematemesis 45.22 13.44 68 326698 27657 50250701
Brain oedema 45.14 13.44 12 326754 12358 50266000
Cyanosis 44.70 13.44 21 326745 15163 50263195
Ileus 44.34 13.44 15 326751 13214 50265144
Mycotic allergy 44.21 13.44 39 326727 780 50277578
Eye swelling 44.11 13.44 39 326727 20105 50258253
Ataxia 43.88 13.44 17 326749 13769 50264589
Viral infection 43.82 13.44 79 326687 29907 50248451
Supraventricular tachycardia 43.81 13.44 14 326752 12787 50265571
Investigation abnormal 43.42 13.44 47 326719 1218 50277140
Muscle rigidity 43.32 13.44 6 326760 9823 50268535
Mouth ulceration 42.84 13.44 319 326447 27705 50250653
Haemorrhoids 42.80 13.44 36 326730 19017 50259341
Cytomegalovirus infection 42.79 13.44 32 326734 17930 50260428
Obstructive airways disorder 42.57 13.44 24 326742 15628 50262730
Aspiration 42.41 13.44 5 326761 9259 50269099
Pustular psoriasis 42.37 13.44 85 326681 3896 50274462
Joint arthroplasty 42.29 13.44 60 326706 2063 50276295
Hepatic failure 42.05 13.44 91 326675 32192 50246166
Shock 41.69 13.44 43 326723 20607 50257751
Atelectasis 41.68 13.44 34 326732 18236 50260122
Myopathy 41.68 13.44 5 326761 9134 50269224
Exostosis 41.40 13.44 167 326599 11486 50266872
Colitis ischaemic 41.30 13.44 6 326760 9477 50268881
Acidosis 41.16 13.44 8 326758 10219 50268139
Delusion 41.02 13.44 9 326757 10560 50267798
Blindness 40.84 13.44 31 326735 17238 50261120
Premature baby 40.76 13.44 35 326731 18302 50260056
Paraesthesia oral 40.71 13.44 14 326752 12207 50266151
Nightmare 40.50 13.44 27 326739 16059 50262299
Pre-eclampsia 40.39 13.44 3 326763 8041 50270317
Tricuspid valve incompetence 40.23 13.44 16 326750 12754 50265604
Soft tissue disorder 40.18 13.44 86 326680 4128 50274230
Interstitial lung disease 40.07 13.44 522 326244 52654 50225704
Clostridium difficile infection 39.95 13.44 64 326702 25375 50252983
Hepatic encephalopathy 39.93 13.44 7 326759 9629 50268729
Multiple sclerosis 39.89 13.44 44 326722 20449 50257909
Hyperbilirubinaemia 39.55 13.44 7 326759 9563 50268795
Neck deformity 39.55 13.44 56 326710 1922 50276436
Throat tightness 39.23 13.44 46 326720 20801 50257557
Dactylitis 39.16 13.44 54 326712 1807 50276551
Ovarian neoplasm 39.02 13.44 37 326729 815 50277543
Ventricular fibrillation 38.99 13.44 10 326756 10549 50267809
Bedridden 38.83 13.44 141 326625 9226 50269132
Device related infection 38.76 13.44 46 326720 20689 50257669
Ventricular extrasystoles 38.75 13.44 10 326756 10506 50267852
Extremity contracture 38.75 13.44 44 326722 1204 50277154
Retinitis 38.58 13.44 54 326712 1833 50276525
Joint dislocation 38.57 13.44 170 326596 12163 50266195
Cardiomegaly 38.51 13.44 28 326738 15917 50262441
Blood calcium increased 38.42 13.44 3 326763 7716 50270642
Urine output decreased 38.23 13.44 10 326756 10411 50267947
Productive cough 37.86 13.44 193 326573 52501 50225857
Electrocardiogram abnormal 37.72 13.44 3 326763 7602 50270756
Femur fracture 37.72 13.44 389 326377 37075 50241283
Retching 37.54 13.44 18 326748 12844 50265514
Hair follicle tumour benign 37.40 13.44 26 326740 361 50277997
Hepatocellular injury 37.35 13.44 69 326697 25878 50252480
Infusion site erythema 36.92 13.44 6 326760 8721 50269637
Dry mouth 36.91 13.44 212 326554 55966 50222392
Stress cardiomyopathy 36.76 13.44 4 326762 7883 50270475
Allergic oedema 36.64 13.44 34 326732 728 50277630
Tumour lysis syndrome 36.61 13.44 3 326763 7418 50270940
Abnormal dreams 36.36 13.44 8 326758 9369 50268989
Swollen tongue 36.23 13.44 82 326684 28548 50249810
Urticarial vasculitis 36.21 13.44 30 326736 549 50277809
Breast cancer metastatic 36.07 13.44 11 326755 10353 50268005
Myelodysplastic syndrome 35.99 13.44 27 326739 15105 50263253
Bloody discharge 35.79 13.44 41 326725 1133 50277225
Rash macular 35.78 13.44 43 326723 19234 50259124
Jaundice 35.68 13.44 73 326693 26356 50252002
Toxic skin eruption 35.60 13.44 14 326752 11237 50267121
Frequent bowel movements 35.53 13.44 23 326743 13895 50264463
Amenorrhoea 35.52 13.44 6 326760 8478 50269880
Alanine aminotransferase abnormal 35.32 13.44 81 326685 4075 50274283
Anal incontinence 35.22 13.44 15 326751 11475 50266883
Infusion site swelling 35.13 13.44 3 326763 7173 50271185
Hypophosphataemia 35.11 13.44 6 326760 8408 50269950
Central nervous system lesion 35.01 13.44 9 326757 9480 50268878
Mental impairment 34.93 13.44 17 326749 12027 50266331
Infiltration anaesthesia 34.58 13.44 18 326748 141 50278217
Flank pain 34.41 13.44 21 326745 13094 50265264
Oesophagitis 34.32 13.44 22 326744 13361 50264997
White blood cell count increased 34.30 13.44 148 326618 42092 50236266
Mean cell haemoglobin decreased 34.23 13.44 70 326696 3253 50275105
Renal injury 34.10 13.44 7 326759 8604 50269754
Localised infection 33.94 13.44 281 326485 25204 50253154
Hip fracture 33.85 13.44 73 326693 25858 50252500
Feeling cold 33.73 13.44 46 326720 19485 50258873
Myelosuppression 33.61 13.44 23 326743 13494 50264864
Vasculitic rash 33.58 13.44 41 326725 1214 50277144
Restless legs syndrome 33.36 13.44 32 326734 15865 50262493
Cystitis 33.29 13.44 161 326605 44403 50233955
Aplastic anaemia 33.26 13.44 5 326761 7698 50270660
Tardive dyskinesia 33.15 13.44 4 326762 7275 50271083
Hypermobility syndrome 33.02 13.44 32 326734 725 50277633
Secretion discharge 32.95 13.44 138 326628 9653 50268705
Haemodynamic instability 32.88 13.44 6 326760 8018 50270340
Upper respiratory tract infection 32.74 13.44 270 326496 65628 50212730
Impaired gastric emptying 32.63 13.44 127 326639 8591 50269767
Throat irritation 32.56 13.44 94 326672 30145 50248213
Headache 32.47 13.44 2823 323943 503712 49774646
Bronchitis 32.43 13.44 475 326291 103684 50174674
Sensory disturbance 32.37 13.44 18 326748 11811 50266547
Acute respiratory distress syndrome 32.28 13.44 54 326712 21045 50257313
Osteonecrosis of jaw 32.25 13.44 105 326661 32421 50245937
Muscle tightness 32.19 13.44 13 326753 10267 50268091
Lymphopenia 32.14 13.44 32 326734 15589 50262769
Osteoporotic fracture 32.10 13.44 66 326700 3079 50275279
Nasal congestion 31.95 13.44 196 326570 50924 50227434
Oliguria 31.88 13.44 7 326759 8209 50270149
Gestational diabetes 31.88 13.44 5 326761 7460 50270898
Anti-cyclic citrullinated peptide antibody 31.72 13.44 45 326721 1547 50276811
Hypotonia 31.42 13.44 7 326759 8127 50270231
Hypercalcaemia 31.37 13.44 258 326508 23094 50255264
Eyelid oedema 31.26 13.44 11 326755 9455 50268903
Skin papilloma 31.18 13.44 78 326688 4151 50274207
Onychomycosis 31.08 13.44 87 326679 4955 50273403
Lower gastrointestinal haemorrhage 30.79 13.44 4 326762 6875 50271483
Drug dependence 30.76 13.44 50 326716 19709 50258649
Haemodialysis 30.72 13.44 8 326758 8354 50270004
Haematocrit decreased 30.62 13.44 119 326647 34857 50243501
Rib fracture 30.52 13.44 48 326718 19173 50259185
Taste disorder 30.51 13.44 8 326758 8316 50270042
Injection site reaction 30.43 13.44 473 326293 49559 50228799
Dermatitis contact 30.41 13.44 9 326757 8637 50269721
Hyperlipidaemia 30.40 13.44 41 326725 17449 50260909
Psychomotor hyperactivity 30.39 13.44 11 326755 9290 50269068
Rhinitis allergic 30.35 13.44 5 326761 7195 50271163
Disease susceptibility 30.30 13.44 18 326748 187 50278171
Labile blood pressure 30.28 13.44 45 326721 1615 50276743
Head discomfort 29.82 13.44 17 326749 11002 50267356
White blood cell count abnormal 29.81 13.44 90 326676 5350 50273008
Blood loss anaemia 29.50 13.44 8 326758 8131 50270227
Migraine 29.50 13.44 327 326439 74953 50203405
Thyroid neoplasm 29.42 13.44 68 326698 3439 50274919
Troponin increased 29.38 13.44 8 326758 8110 50270248
Atrioventricular block first degree 29.27 13.44 3 326763 6198 50272160
Angina pectoris 29.24 13.44 80 326686 26108 50252250
Injection site mass 29.08 13.44 35 326731 15645 50262713
Apnoea 29.00 13.44 5 326761 6961 50271397
Bone disorder 28.97 13.44 214 326552 18538 50259820
No adverse event 28.91 13.44 115 326651 33463 50244895
Faeces discoloured 28.84 13.44 37 326729 16087 50262271
Shock haemorrhagic 28.78 13.44 9 326757 8335 50270023
Sudden death 28.76 13.44 11 326755 8980 50269378
Glomerular filtration rate decreased 28.75 13.44 20 326746 11632 50266726
Influenza like illness 28.73 13.44 235 326531 57224 50221134
Pulmonary haemorrhage 28.52 13.44 4 326762 6488 50271870
Ankle deformity 28.50 13.44 23 326743 405 50277953
Acute generalised exanthematous pustulosis 28.48 13.44 11 326755 8927 50269431
Atrioventricular block 28.44 13.44 4 326762 6474 50271884
Ovarian cyst 28.42 13.44 29 326737 13967 50264391
Device breakage 28.42 13.44 13 326753 9534 50268824
Synovial cyst 28.19 13.44 116 326650 8050 50270308
Immobile 28.06 13.44 84 326682 4970 50273388
Hypoaesthesia 28.00 13.44 617 326149 126640 50151718
Pelvic pain 27.99 13.44 19 326747 11194 50267164
Eosinophil count increased 27.92 13.44 11 326755 8819 50269539
Macular degeneration 27.89 13.44 31 326735 14357 50264001
Oral discomfort 27.77 13.44 114 326652 7903 50270455
Eructation 27.77 13.44 6 326760 7115 50271243
Heart rate decreased 27.76 13.44 131 326635 36366 50241992
Chromaturia 27.66 13.44 32 326734 14558 50263800
Atrial septal defect 27.64 13.44 4 326762 6337 50272021
Therapy non-responder 27.55 13.44 473 326293 50549 50227809
Injection site hypersensitivity 27.54 13.44 45 326721 1755 50276603
Sinus disorder 27.54 13.44 48 326718 18410 50259948
Pemphigoid 27.52 13.44 3 326763 5904 50272454
Coagulopathy 27.38 13.44 46 326720 17898 50260460
Sensory loss 27.31 13.44 8 326758 7730 50270628
Hemiplegia 27.24 13.44 7 326759 7374 50270984
Spinal stenosis 27.18 13.44 165 326601 13385 50264973
Blood triglycerides increased 27.14 13.44 20 326746 11292 50267066
Haemolytic anaemia 27.12 13.44 13 326753 9279 50269079
Epstein-Barr virus infection 27.07 13.44 6 326760 6991 50271367
Gastroenteritis viral 27.00 13.44 50 326716 18736 50259622
Functional gastrointestinal disorder 26.98 13.44 65 326701 3377 50274981
Polyarthritis 26.89 13.44 112 326654 7815 50270543
Limb operation 26.88 13.44 64 326702 3300 50275058
Walking aid user 26.81 13.44 97 326669 6336 50272022
Cholecystitis 26.76 13.44 30 326736 13841 50264517
Intestinal sepsis 26.63 13.44 18 326748 238 50278120
Influenza 26.61 13.44 412 326354 89126 50189232
Menstruation irregular 26.60 13.44 4 326762 6158 50272200
Unevaluable event 26.56 13.44 181 326585 45885 50232473
Neuralgia 26.55 13.44 64 326702 21799 50256559
Bradyphrenia 26.54 13.44 4 326762 6148 50272210
End stage renal disease 26.51 13.44 3 326763 5734 50272624
Hypercholesterolaemia 26.39 13.44 147 326619 11556 50266802
Skin laceration 26.33 13.44 51 326715 18791 50259567
Peripheral coldness 26.24 13.44 17 326749 10266 50268092
Lupus-like syndrome 26.11 13.44 126 326640 9365 50268993
Tubulointerstitial nephritis 26.09 13.44 36 326730 15175 50263183
Colitis microscopic 26.07 13.44 97 326669 6423 50271935
Acute coronary syndrome 26.04 13.44 14 326752 9360 50268998
Musculoskeletal chest pain 25.87 13.44 50 326716 18436 50259922
Neck mass 25.85 13.44 63 326703 3298 50275060
Photophobia 25.77 13.44 35 326731 14852 50263506
Rash maculo-papular 25.73 13.44 87 326679 26554 50251804
Device malfunction 25.73 13.44 36 326730 15085 50263273
Pre-existing condition improved 25.68 13.44 7 326759 7090 50271268
Failure to thrive 25.53 13.44 5 326761 6353 50272005
Increased appetite 25.49 13.44 11 326755 8350 50270008
Mycobacterium tuberculosis complex test positive 25.48 13.44 43 326723 1723 50276635
Nystagmus 25.46 13.44 3 326763 5558 50272800
Angina unstable 25.45 13.44 6 326760 6700 50271658
Polyomavirus-associated nephropathy 25.39 13.44 40 326726 1512 50276846
Accident 25.35 13.44 82 326684 5059 50273299
Mood altered 25.33 13.44 27 326739 12746 50265612
Progressive multifocal leukoencephalopathy 25.30 13.44 22 326744 11435 50266923
Toxic encephalopathy 25.19 13.44 3 326763 5512 50272846
Off label use 25.11 13.44 3462 323304 470964 49807394
Neutrophil count increased 24.95 13.44 33 326733 14162 50264196
Posterior reversible encephalopathy syndrome 24.94 13.44 36 326730 14892 50263466
Acute pulmonary oedema 24.77 13.44 8 326758 7259 50271099
Fracture delayed union 24.71 13.44 49 326717 2227 50276131
Ageusia 24.68 13.44 23 326743 11560 50266798
Major depression 24.51 13.44 7 326759 6877 50271481
Drug level decreased 24.49 13.44 6 326760 6527 50271831
Heavy menstrual bleeding 24.48 13.44 39 326727 15498 50262860
Atrial flutter 24.47 13.44 13 326753 8750 50269608
Food allergy 24.34 13.44 11 326755 8126 50270232
Eye irritation 24.30 13.44 46 326720 17094 50261264
Suspected suicide 24.26 13.44 3 326763 5354 50273004
Thinking abnormal 24.16 13.44 16 326750 9551 50268807
Thirst 24.07 13.44 20 326746 10630 50267728
Cold sweat 24.05 13.44 20 326746 10624 50267734
Diabetic eye disease 24.02 13.44 14 326752 140 50278218
Respiratory tract infection 23.72 13.44 116 326650 31901 50246457
Nocturia 23.68 13.44 7 326759 6723 50271635
Brain injury 23.59 13.44 5 326761 6009 50272349
Dialysis 23.55 13.44 16 326750 9422 50268936
Granulocytopenia 23.52 13.44 3 326763 5228 50273130
Mass excision 23.52 13.44 17 326749 252 50278106
Subarachnoid haemorrhage 23.43 13.44 21 326745 10755 50267603
Prothrombin time prolonged 23.40 13.44 14 326752 8824 50269534
General physical health deterioration 23.29 13.44 1134 325632 141300 50137058
Blood lactic acid increased 23.27 13.44 4 326762 5581 50272777
Red blood cell count decreased 23.14 13.44 126 326640 33709 50244649
Foetal growth restriction 23.12 13.44 7 326759 6620 50271738
Blood albumin decreased 23.03 13.44 31 326735 13205 50265153
Joint space narrowing 23.02 13.44 16 326750 222 50278136
Cerebral ischaemia 22.99 13.44 5 326761 5903 50272455
Salivary hypersecretion 22.93 13.44 7 326759 6584 50271774
Immune thrombocytopenia 22.88 13.44 15 326751 9002 50269356
Liver injury 22.84 13.44 253 326513 24553 50253805
Hypothyroidism 22.84 13.44 128 326638 33997 50244361
Enterocolitis 22.80 13.44 7 326759 6560 50271798
Hyperthyroidism 22.76 13.44 27 326739 12148 50266210
Spinal compression fracture 22.68 13.44 29 326737 12627 50265731
Middle lobe syndrome 22.59 13.44 9 326757 34 50278324
Hereditary angioedema 22.45 13.44 4 326762 5438 50272920
Hepatitis cholestatic 22.19 13.44 6 326760 6111 50272247
Hyperthermia 22.11 13.44 11 326755 7685 50270673
Petechiae 22.08 13.44 29 326737 12483 50265875
Bipolar disorder 22.06 13.44 8 326758 6749 50271609
Seasonal allergy 22.05 13.44 38 326728 14638 50263720
Osteomyelitis 21.98 13.44 231 326535 22122 50256236
Drug resistance 21.96 13.44 57 326709 18932 50259426
Cardiac failure acute 21.94 13.44 13 326753 8237 50270121
Purpura 21.93 13.44 19 326747 9892 50268466
Arthritis bacterial 21.89 13.44 83 326683 5546 50272812
Unintended pregnancy 21.84 13.44 3 326763 4943 50273415
Hepatic enzyme abnormal 21.83 13.44 75 326691 4774 50273584
Arteriosclerosis coronary artery 21.81 13.44 11 326755 7625 50270733
Injection site haemorrhage 21.80 13.44 68 326698 21278 50257080
Fistula 21.78 13.44 13 326753 8205 50270153
Hepatic ischaemia 21.68 13.44 23 326743 582 50277776
Hypoacusis 21.63 13.44 65 326701 20582 50257776
Spinal meningioma benign 21.56 13.44 12 326754 109 50278249
Personality change 21.52 13.44 5 326761 5640 50272718
Rheumatic disorder 21.51 13.44 37 326729 1506 50276852
Myocardial ischaemia 21.45 13.44 26 326740 11587 50266771
Exercise tolerance decreased 21.42 13.44 3 326763 4871 50273487
Localised oedema 21.38 13.44 3 326763 4864 50273494
Road traffic accident 21.22 13.44 83 326683 24269 50254089
Generalised oedema 21.14 13.44 35 326731 13696 50264662
Cardiomyopathy 21.08 13.44 43 326723 15543 50262815
Polyp 21.06 13.44 5 326761 5557 50272801
Scleroderma 21.00 13.44 3 326763 4798 50273560
Bundle branch block left 20.99 13.44 7 326759 6223 50272135
Nephropathy toxic 20.86 13.44 13 326753 8016 50270342
Skin reaction 20.80 13.44 137 326629 11431 50266927
Escherichia infection 20.74 13.44 24 326742 10917 50267441
Hypoalbuminaemia 20.51 13.44 20 326746 9840 50268518
Hiatus hernia 20.50 13.44 56 326710 18288 50260070
Myocarditis 20.47 13.44 13 326753 7934 50270424
Contusion 20.46 13.44 903 325863 111280 50167078
Glycosylated haemoglobin increased 20.39 13.44 23 326743 10583 50267775
Rheumatoid factor 20.39 13.44 10 326756 68 50278290
Extra dose administered 20.36 13.44 4 326762 5072 50273286
Humerus fracture 20.26 13.44 12 326754 7606 50270752
Refusal of treatment by patient 20.23 13.44 4 326762 5049 50273309
Systemic inflammatory response syndrome 20.21 13.44 4 326762 5045 50273313
Hyperventilation 20.21 13.44 5 326761 5404 50272954
Oligohydramnios 20.19 13.44 6 326760 5744 50272614
Peritonitis bacterial 20.18 13.44 3 326763 4658 50273700
Lymphadenopathy 20.13 13.44 130 326636 33369 50244989
Nail disorder 19.97 13.44 119 326647 9589 50268769
Incorrect dosage administered 19.94 13.44 38 326728 1676 50276682
Product storage error 19.91 13.44 30 326736 12194 50266164
Bronchiectasis 19.85 13.44 124 326642 10159 50268199
Hypoaesthesia oral 19.84 13.44 24 326742 10704 50267654
Cellulitis gangrenous 19.70 13.44 9 326757 51 50278307
Amyotrophic lateral sclerosis 19.57 13.44 29 326737 1038 50277320
Lymphoedema 19.57 13.44 18 326748 9104 50269254
Motor dysfunction 19.53 13.44 14 326752 8017 50270341
Overwork 19.41 13.44 9 326757 53 50278305
Dental caries 19.41 13.44 21 326745 9846 50268512
Erythema multiforme 19.24 13.44 18 326748 9032 50269326
Back pain 19.23 13.44 1194 325572 218836 50059522
Intermenstrual bleeding 19.19 13.44 10 326756 6804 50271554
Eyelid ptosis 19.09 13.44 8 326758 6179 50272179
Serum ferritin increased 19.07 13.44 5 326761 5197 50273161
Drug tolerance 19.04 13.44 73 326693 4903 50273455
Heart rate irregular 18.85 13.44 63 326703 19297 50259061
Soft tissue swelling 18.59 13.44 27 326739 949 50277409
Infusion site extravasation 18.54 13.44 11 326755 6965 50271393
Salt craving 18.53 13.44 10 326756 85 50278273
Metastasis 18.52 13.44 3 326763 4372 50273986
Steatohepatitis 18.52 13.44 19 326747 462 50277896
Embolism 18.50 13.44 11 326755 6957 50271401
Menstrual disorder 18.50 13.44 3 326763 4367 50273991
Poor quality sleep 18.47 13.44 51 326715 16595 50261763
Asphyxia 18.46 13.44 6 326760 5421 50272937
Blood pressure systolic decreased 18.39 13.44 7 326759 5732 50272626
Ocular toxicity 18.27 13.44 20 326746 525 50277833
Aortic arteriosclerosis 18.22 13.44 6 326760 5376 50272982
Expired product administered 18.22 13.44 6 326760 5376 50272982
Klebsiella infection 18.21 13.44 12 326754 7182 50271176
Stress at work 18.19 13.44 28 326738 1037 50277321
Upper-airway cough syndrome 18.19 13.44 17 326749 8533 50269825
Lipase increased 18.15 13.44 17 326749 8524 50269834
Extrasystoles 17.99 13.44 4 326762 4651 50273707
Intervertebral disc space narrowing 17.96 13.44 26 326740 911 50277447
Polyuria 17.86 13.44 12 326754 7109 50271249
Wound infection 17.84 13.44 137 326629 12011 50266347
Intracranial pressure increased 17.82 13.44 3 326763 4249 50274109
Liver function test abnormal 17.81 13.44 393 326373 43946 50234412
Cholecystitis acute 17.79 13.44 12 326754 7094 50271264
Metabolic disorder 17.70 13.44 6 326760 5280 50273078
Concussion 17.65 13.44 14 326752 7614 50270744
Dry throat 17.58 13.44 7 326759 5577 50272781
Hepatic fibrosis 17.57 13.44 53 326713 3149 50275209
Respiratory rate increased 17.54 13.44 29 326737 11356 50267002
Enthesophyte 17.46 13.44 6 326760 13 50278345
Injection site erythema 17.44 13.44 360 326406 74576 50203782
Muscle relaxant therapy 17.42 13.44 12 326754 164 50278194
Metastases to lymph nodes 17.40 13.44 12 326754 7012 50271346
Eye movement disorder 17.38 13.44 4 326762 4541 50273817
Hepatic cytolysis 17.37 13.44 16 326750 8087 50270271
Anger 17.34 13.44 29 326737 11304 50267054
Diverticulum 17.34 13.44 26 326740 10588 50267770
Concomitant disease aggravated 17.31 13.44 16 326750 8075 50270283
Brain natriuretic peptide increased 17.28 13.44 4 326762 4523 50273835
Congestive cardiomyopathy 17.24 13.44 7 326759 5511 50272847
International normalised ratio decreased 17.22 13.44 3 326763 4145 50274213
Rhinorrhoea 17.19 13.44 232 326534 51351 50227007
Pleural thickening 17.17 13.44 46 326720 2553 50275805
Activated partial thromboplastin time prolonged 17.15 13.44 10 326756 6392 50271966
Arteriosclerosis 17.11 13.44 20 326746 9057 50269301
Large intestine perforation 17.03 13.44 14 326752 7480 50270878
Aortic valve incompetence 17.02 13.44 7 326759 5469 50272889
Post procedural complication 16.96 13.44 46 326720 15058 50263300
Product complaint 16.94 13.44 30 326736 11436 50266922
Acne 16.94 13.44 67 326699 19528 50258830
Appendicitis 16.84 13.44 11 326755 6613 50271745
Live birth 16.81 13.44 171 326595 16237 50262121
Choking 16.81 13.44 18 326748 8480 50269878
Feeling jittery 16.67 13.44 29 326737 11131 50267227
Gingival pain 16.64 13.44 9 326757 5997 50272361
Injection site swelling 16.54 13.44 181 326585 41592 50236766
Forced expiratory volume decreased 16.54 13.44 4 326762 4390 50273968
Vascular device infection 16.48 13.44 4 326762 4380 50273978
Hyperammonaemia 16.46 13.44 5 326761 4719 50273639
Spinal fusion surgery 16.45 13.44 60 326706 3935 50274423
Splenomegaly 16.43 13.44 23 326743 9637 50268721
Lung infiltration 16.43 13.44 39 326727 13354 50265004
Limb injury 16.41 13.44 71 326695 20179 50258179
Procedural pain 16.40 13.44 41 326725 13791 50264567
Staphylococcal infection 16.32 13.44 149 326617 35467 50242891
Hypertonia 16.22 13.44 3 326763 3970 50274388
Intervertebral disc compression 16.20 13.44 25 326741 928 50277430
Vitreous floaters 16.19 13.44 7 326759 5307 50273051
Fungal infection 16.17 13.44 120 326646 29845 50248513
Wrist fracture 16.13 13.44 31 326735 11456 50266902
Pneumonia fungal 16.13 13.44 4 326762 4316 50274042
Ear discomfort 16.08 13.44 12 326754 6732 50271626
Breast pain 16.05 13.44 15 326751 7529 50270829
Lung neoplasm malignant 16.04 13.44 49 326717 15435 50262923
Rash papular 16.03 13.44 36 326730 12568 50265790
Device leakage 16.00 13.44 9 326757 5869 50272489
Enteritis 15.98 13.44 13 326753 6982 50271376
Acute hepatic failure 15.97 13.44 50 326716 15627 50262731
Drug level above therapeutic 15.92 13.44 3 326763 3917 50274441
Dizziness postural 15.90 13.44 10 326756 6135 50272223
Neck surgery 15.88 13.44 32 326734 1471 50276887
Bacterial infection 15.83 13.44 53 326713 16228 50262130
Rales 15.77 13.44 25 326741 9953 50268405
Clear cell renal cell carcinoma 15.67 13.44 28 326738 1175 50277183
Hypertriglyceridaemia 15.55 13.44 8 326758 5483 50272875
Hypovolaemic shock 15.54 13.44 7 326759 5181 50273177
Tumour marker increased 15.46 13.44 3 326763 3837 50274521
Decubitus ulcer 15.45 13.44 23 326743 9395 50268963
C-reactive protein 15.32 13.44 23 326743 833 50277525
Haemolysis 15.28 13.44 10 326756 6006 50272352
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.24 13.44 41 326725 2281 50276077
Mycobacterium marinum infection 15.22 13.44 12 326754 204 50278154
Viral upper respiratory tract infection 15.20 13.44 87 326679 6909 50271449
Juvenile idiopathic arthritis 15.19 13.44 47 326719 2832 50275526
Glucose tolerance impaired 15.19 13.44 7 326759 5111 50273247
Jaundice cholestatic 15.15 13.44 7 326759 5104 50273254
Malignant neoplasm of conjunctiva 15.13 13.44 7 326759 41 50278317
Bronchopulmonary aspergillosis 15.11 13.44 16 326750 7576 50270782
Respiration abnormal 15.10 13.44 7 326759 5095 50273263
Odynophagia 15.10 13.44 12 326754 6520 50271838
Hydrocephalus 15.08 13.44 6 326760 4782 50273576
Orthopnoea 15.08 13.44 9 326757 5680 50272678
Maternal drugs affecting foetus 14.98 13.44 7 326759 5070 50273288
Stillbirth 14.97 13.44 10 326756 5942 50272416
Colitis ulcerative 14.97 13.44 57 326709 16797 50261561
Inflammatory marker increased 14.93 13.44 74 326692 5560 50272798
Mean cell haemoglobin concentration abnormal 14.92 13.44 8 326758 67 50278291
Exposure to communicable disease 14.90 13.44 18 326748 527 50277831
Drug level below therapeutic 14.89 13.44 3 326763 3737 50274621
Weight increased 14.87 13.44 1505 325261 200386 50077972
Sneezing 14.87 13.44 44 326722 14000 50264358
Hydronephrosis 14.87 13.44 20 326746 8521 50269837
Blood potassium increased 14.86 13.44 55 326711 16343 50262015
Lyme disease 14.82 13.44 43 326723 2500 50275858
Internal haemorrhage 14.82 13.44 5 326761 4412 50273946
Pleuritic pain 14.79 13.44 12 326754 6454 50271904
Micturition urgency 14.74 13.44 19 326747 8245 50270113
Affect lability 14.74 13.44 22 326744 8976 50269382
Spinal cord compression 14.72 13.44 3 326763 3706 50274652
Ileus paralytic 14.64 13.44 4 326762 4046 50274312
Diastolic dysfunction 14.61 13.44 8 326758 5294 50273064
Ventricular septal defect 14.59 13.44 4 326762 4037 50274321
Anxiety disorder 14.52 13.44 3 326763 3670 50274688
Product residue present 14.51 13.44 3 326763 3669 50274689
Urine analysis abnormal 14.46 13.44 5 326761 4345 50274013
Hepatic necrosis 14.34 13.44 8 326758 5240 50273118
Bundle branch block right 14.34 13.44 6 326760 4639 50273719
Thrombophlebitis 14.33 13.44 4 326762 3989 50274369
Blood thyroid stimulating hormone increased 14.32 13.44 11 326755 6081 50272277
Tendonitis 14.31 13.44 168 326598 16537 50261821
Spinal fracture 14.27 13.44 52 326714 15521 50262837
Blood culture positive 14.24 13.44 5 326761 4303 50274055
Uterine leiomyoma 14.23 13.44 18 326748 7873 50270485
Bunion operation 14.22 13.44 26 326740 1111 50277247
Bowel movement irregularity 14.19 13.44 4 326762 3964 50274394
Proteinuria 14.19 13.44 57 326709 16540 50261818
Photopsia 14.18 13.44 4 326762 3962 50274396
Hypertransaminasaemia 14.17 13.44 3 326763 3608 50274750
Vitamin D deficiency 14.15 13.44 33 326733 11369 50266989
Joint noise 14.04 13.44 53 326713 3534 50274824
Retinal haemorrhage 14.01 13.44 6 326760 4575 50273783
Premature rupture of membranes 14.00 13.44 6 326760 4574 50273784
Large intestine polyp 13.99 13.44 16 326750 7316 50271042
Arthritis infective 13.95 13.44 72 326694 5497 50272861
Root canal infection 13.94 13.44 12 326754 232 50278126
Acute hepatitis C 13.90 13.44 8 326758 78 50278280
Ammonia increased 13.88 13.44 5 326761 4236 50274122
Exposure during pregnancy 13.87 13.44 933 325833 120082 50158276
Illness 13.86 13.44 97 326669 24443 50253915
Cardiac tamponade 13.84 13.44 5 326761 4227 50274131
Gingivitis 13.78 13.44 16 326750 7268 50271090
Oxygen consumption increased 13.74 13.44 3 326763 3533 50274825
Middle insomnia 13.74 13.44 27 326739 9894 50268464
Granuloma 13.73 13.44 65 326701 4793 50273565
Osteonecrosis 13.72 13.44 87 326679 22430 50255928
Hepatomegaly 13.58 13.44 31 326735 10762 50267596
Tongue disorder 13.57 13.44 104 326662 9112 50269246
Skin irritation 13.54 13.44 18 326748 7709 50270649
Deafness 13.53 13.44 158 326608 15533 50262825
Pain of skin 13.44 13.44 19 326747 7928 50270430

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
Drug ineffective 2336.09 15.08 3088 51899 360082 29159458
Rheumatoid arthritis 1538.98 15.08 875 54112 31277 29488263
Joint swelling 1518.91 15.08 1015 53972 48615 29470925
Drug intolerance 1460.15 15.08 981 54006 47398 29472142
Contraindicated product administered 883.33 15.08 501 54486 17765 29501775
Treatment failure 713.58 15.08 573 54414 36366 29483174
Synovitis 631.82 15.08 337 54650 10553 29508987
C-reactive protein abnormal 608.10 15.08 279 54708 6257 29513283
Apparent death 589.56 15.08 228 54759 3276 29516264
Arthralgia 545.16 15.08 949 54038 138668 29380872
Bone erosion 483.64 15.08 185 54802 2575 29516965
Arthropathy 464.75 15.08 357 54630 21197 29498343
Diverticulitis 434.63 15.08 317 54670 17387 29502153
Musculoskeletal stiffness 427.25 15.08 432 54555 37026 29482514
Therapeutic product effect decreased 417.72 15.08 383 54604 29068 29490472
Pain 409.88 15.08 950 54037 170482 29349058
Red blood cell sedimentation rate abnormal 405.79 15.08 155 54832 2148 29517392
Drug hypersensitivity 378.30 15.08 546 54441 67860 29451680
Drug eruption 323.49 15.08 260 54727 16481 29503059
Loss of personal independence in daily activities 322.64 15.08 311 54676 25129 29494411
Psoriatic arthropathy 294.16 15.08 233 54754 14458 29505082
Urticaria 291.43 15.08 429 54558 54231 29465309
Stomatitis 278.33 15.08 344 54643 36769 29482771
Mobility decreased 275.10 15.08 287 54700 25493 29494047
Death 270.05 15.08 151 54836 341933 29177607
Pain in extremity 249.07 15.08 599 54388 109834 29409706
Red blood cell sedimentation rate increased 245.32 15.08 160 54827 7301 29512239
Hypersensitivity 228.61 15.08 377 54610 52526 29467014
Disability 220.98 15.08 124 54863 4292 29515248
C-reactive protein increased 216.75 15.08 334 54653 43929 29475611
Sleep disorder due to general medical condition, insomnia type 214.36 15.08 83 54904 1195 29518345
Hand deformity 198.27 15.08 91 54896 2039 29517501
Hypotension 198.09 15.08 58 54929 194296 29325244
Impaired work ability 187.98 15.08 122 54865 5518 29514022
Rheumatoid factor negative 183.46 15.08 66 54921 764 29518776
Febrile neutropenia 174.96 15.08 8 54979 112232 29407308
Acute kidney injury 173.04 15.08 144 54843 265123 29254417
Therapeutic product effect incomplete 172.28 15.08 282 54705 39023 29480517
Arthritis 168.63 15.08 220 54767 24799 29494741
Knee arthroplasty 163.20 15.08 113 54874 5696 29513844
Chondropathy 162.67 15.08 62 54925 853 29518687
Peripheral swelling 157.93 15.08 359 54628 63380 29456160
Pulmonary thrombosis 157.50 15.08 116 54871 6449 29513091
Anti-cyclic citrullinated peptide antibody positive 147.09 15.08 56 54931 768 29518772
Gastrointestinal disorder 143.80 15.08 219 54768 28487 29491053
Anaemia 142.50 15.08 100 54887 200851 29318689
Toxicity to various agents 141.91 15.08 73 54914 173588 29345952
Onychoclasis 141.88 15.08 68 54919 1685 29517855
Alanine aminotransferase abnormal 139.76 15.08 80 54907 2877 29516663
Limb discomfort 138.56 15.08 126 54861 9442 29510098
Confusional state 136.08 15.08 35 54952 127842 29391698
Rheumatoid nodule 135.30 15.08 70 54917 2052 29517488
Tenosynovitis 134.94 15.08 85 54902 3648 29515892
Enthesopathy 134.73 15.08 85 54902 3658 29515882
Lymphoma 131.82 15.08 124 54863 9704 29509836
Osteoarthritis 131.11 15.08 165 54822 17938 29501602
Drug interaction 129.97 15.08 106 54881 197279 29322261
Hepatic function abnormal 129.82 15.08 249 54738 39010 29480530
Bone cyst 128.29 15.08 46 54941 527 29519013
Atlantoaxial instability 125.97 15.08 40 54947 305 29519235
Swelling 125.64 15.08 231 54756 35052 29484488
Spinal instability 123.76 15.08 40 54947 325 29519215
Drug tolerance decreased 123.70 15.08 57 54930 1289 29518251
Mineral metabolism disorder 123.01 15.08 40 54947 332 29519208
Terminal state 122.41 15.08 78 54909 3416 29516124
Herpes zoster 121.49 15.08 208 54779 29844 29489696
Dislocation of vertebra 120.26 15.08 40 54947 359 29519181
Overdose 120.21 15.08 7 54980 79812 29439728
Malignant neoplasm progression 119.34 15.08 4 54983 73855 29445685
Sarcoidosis 118.32 15.08 69 54918 2571 29516969
Acne cystic 115.43 15.08 41 54946 456 29519084
Dehydration 115.37 15.08 35 54952 114713 29404827
Intervertebral disc space narrowing 115.06 15.08 46 54941 724 29518816
Drug specific antibody present 114.95 15.08 67 54920 2494 29517046
Constipation 109.16 15.08 38 54949 114122 29405418
Thrombocytopenia 108.12 15.08 58 54929 134765 29384775
Tooth loss 104.44 15.08 72 54915 3602 29515938
Alopecia 103.29 15.08 151 54836 18933 29500607
Inflammation 100.79 15.08 164 54823 22564 29496976
Joint ankylosis 98.80 15.08 35 54952 386 29519154
Rhabdomyolysis 95.80 15.08 4 54983 60804 29458736
Dizziness 94.39 15.08 129 54858 189555 29329985
Tongue disorder 91.62 15.08 73 54914 4563 29514977
Pyrexia 88.69 15.08 259 54728 287363 29232177
Decreased appetite 88.40 15.08 84 54903 145258 29374282
Epistaxis 88.18 15.08 253 54734 51451 29468089
Rheumatoid factor positive 86.98 15.08 36 54951 622 29518918
Vomiting 86.24 15.08 165 54822 212095 29307445
Osteosclerosis 83.00 15.08 41 54946 1087 29518453
Joint stiffness 82.77 15.08 95 54892 9378 29510162
Bradycardia 80.02 15.08 13 54974 65616 29453924
Hyperkalaemia 79.89 15.08 10 54977 61382 29458158
Muscle spasms 79.54 15.08 284 54703 64798 29454742
Foot deformity 78.87 15.08 63 54924 3952 29515588
Fall 77.98 15.08 131 54856 177047 29342493
Seizure 77.68 15.08 38 54949 93085 29426455
Drug use disorder 76.57 15.08 58 54929 3364 29516176
Tooth fracture 76.22 15.08 56 54931 3100 29516440
Joint arthroplasty 76.11 15.08 33 54954 643 29518897
Ill-defined disorder 76.03 15.08 101 54886 11577 29507963
Somnolence 75.89 15.08 40 54947 93915 29425625
Neutropenia 75.63 15.08 80 54907 131631 29387909
Liver function test increased 74.64 15.08 101 54886 11784 29507756
Cytology abnormal 74.34 15.08 28 54959 372 29519168
Hip arthroplasty 73.89 15.08 59 54928 3699 29515841
Pulmonary fibrosis 72.58 15.08 115 54872 15467 29504073
Agitation 70.18 15.08 7 54980 51297 29468243
End stage renal disease 68.89 15.08 78 54909 7586 29511954
Deep vein thrombosis 68.87 15.08 249 54738 57150 29462390
Cardiac arrest 66.85 15.08 38 54949 85553 29433987
Infection 65.84 15.08 300 54687 76451 29443089
Osteolysis 65.15 15.08 39 54948 1526 29518014
Nodule 63.80 15.08 62 54925 5050 29514490
Disease progression 63.07 15.08 37 54950 81879 29437661
Photosensitivity reaction 61.70 15.08 81 54906 9177 29510363
International normalised ratio increased 60.83 15.08 6 54981 44366 29475174
Atrial fibrillation 60.82 15.08 64 54923 105582 29413958
Seronegative arthritis 60.40 15.08 31 54956 893 29518647
Joint lock 59.94 15.08 33 54954 1099 29518441
Tendonitis 59.92 15.08 74 54913 7887 29511653
Intentional overdose 59.16 15.08 3 54984 38525 29481015
Intestinal sepsis 57.81 15.08 24 54963 418 29519122
Haemorrhage 57.06 15.08 8 54979 45064 29474476
Joint range of motion decreased 55.07 15.08 62 54925 5992 29513548
Hallucination 54.17 15.08 9 54978 44703 29474837
Platelet count decreased 53.18 15.08 70 54917 104602 29414938
Cardiac failure congestive 52.98 15.08 39 54948 76542 29442998
Hypokalaemia 52.84 15.08 14 54973 50189 29469351
Mental status changes 52.75 15.08 3 54984 34924 29484616
Skin ulcer 52.11 15.08 111 54876 18729 29500811
Skin laceration 52.01 15.08 82 54905 10980 29508560
Mass 51.76 15.08 65 54922 7046 29512494
Suicide attempt 51.30 15.08 3 54984 34107 29485433
Tachycardia 51.23 15.08 36 54951 72374 29447166
Musculoskeletal discomfort 51.08 15.08 61 54926 6280 29513260
Plasma cell myeloma 50.92 15.08 5 54982 37110 29482430
Prerenal failure 50.73 15.08 35 54952 1753 29517787
Gait inability 50.52 15.08 108 54879 18267 29501273
Fine motor skill dysfunction 50.33 15.08 33 54954 1518 29518022
Ankle deformity 50.06 15.08 18 54969 208 29519332
Hyponatraemia 50.04 15.08 32 54955 67601 29451939
Musculoskeletal pain 49.64 15.08 142 54845 28811 29490729
Syncope 49.44 15.08 47 54940 81324 29438216
Exposure via body fluid 47.98 15.08 15 54972 108 29519432
Oral surgery 46.27 15.08 22 54965 535 29519005
Abdominal pain 45.99 15.08 116 54871 135241 29384299
Pneumonia aspiration 45.39 15.08 7 54980 36730 29482810
Blood glucose increased 44.89 15.08 27 54960 58957 29460583
Pulmonary embolism 44.74 15.08 269 54718 76265 29443275
Pulmonary mass 44.21 15.08 75 54912 10673 29508867
Physical disability 43.94 15.08 28 54959 1226 29518314
Dyspnoea 43.75 15.08 393 54594 326339 29193201
Urinary tract infection 43.71 15.08 42 54945 72312 29447228
Myalgia 43.53 15.08 44 54943 73975 29445565
Soft tissue swelling 43.02 15.08 18 54969 320 29519220
Hypoglycaemia 42.99 15.08 18 54969 48328 29471212
Electrocardiogram QT prolonged 42.20 15.08 8 54979 36129 29483411
Polyomavirus-associated nephropathy 42.03 15.08 41 54946 3355 29516185
Cardio-respiratory arrest 41.64 15.08 21 54966 50580 29468960
Hyperglycaemia 41.32 15.08 7 54980 34280 29485260
Neutrophil count decreased 40.75 15.08 15 54972 43552 29475988
Tuberculin test positive 40.21 15.08 25 54962 1048 29518492
Skin mass 39.71 15.08 40 54947 3403 29516137
Medical device implantation 39.65 15.08 20 54967 555 29518985
Delirium 39.58 15.08 12 54975 39385 29480155
Cerebrovascular accident 39.49 15.08 51 54936 76860 29442680
Interstitial lung disease 39.07 15.08 211 54776 57507 29462033
Finger deformity 38.82 15.08 25 54962 1115 29518425
Joint effusion 38.31 15.08 43 54944 4141 29515399
Blood creatine phosphokinase increased 38.00 15.08 14 54973 40630 29478910
Therapeutic response decreased 37.42 15.08 116 54871 24595 29494945
Immobile 37.36 15.08 32 54955 2213 29517327
Loss of consciousness 37.11 15.08 50 54937 74006 29445534
X-ray abnormal 37.04 15.08 18 54969 460 29519080
Musculoskeletal disorder 36.72 15.08 47 54940 5193 29514347
Grip strength decreased 36.60 15.08 32 54955 2275 29517265
Product dose omission issue 35.59 15.08 79 54908 96304 29423236
Hospitalisation 35.06 15.08 21 54966 45967 29473573
Intentional product use issue 34.84 15.08 164 54823 42334 29477206
Flushing 34.75 15.08 6 54981 28986 29490554
Tooth disorder 34.66 15.08 63 54924 9466 29510074
Pyopneumothorax 33.83 15.08 10 54977 58 29519482
Dysarthria 33.72 15.08 8 54979 30903 29488637
Limb deformity 33.02 15.08 17 54970 493 29519047
Neoplasm malignant 32.97 15.08 87 54900 16838 29502702
Lactic acidosis 32.66 15.08 8 54979 30239 29489301
Ankylosing spondylitis 31.72 15.08 39 54948 4137 29515403
Respiratory failure 31.62 15.08 85 54902 97046 29422494
Urinary retention 31.53 15.08 10 54977 31888 29487652
Renal impairment 31.41 15.08 65 54922 81268 29438272
Blood creatinine increased 31.21 15.08 70 54917 85032 29434508
Haematuria 31.14 15.08 22 54965 44117 29475423
Granuloma 30.96 15.08 30 54957 2434 29517106
Rheumatoid lung 30.88 15.08 15 54972 383 29519157
Diabetes mellitus 30.69 15.08 151 54836 39680 29479860
Unresponsive to stimuli 30.56 15.08 5 54982 25121 29494419
Gastrointestinal haemorrhage 30.34 15.08 64 54923 79469 29440071
Abdominal distension 29.69 15.08 25 54962 45886 29473654
Exostosis 29.69 15.08 35 54952 3554 29515986
Hypoxia 29.20 15.08 27 54960 47352 29472188
Condition aggravated 29.19 15.08 407 54580 145888 29373652
Suicidal ideation 29.17 15.08 14 54973 34702 29484838
Intentional product misuse 29.09 15.08 14 54973 34647 29484893
Hepatic cirrhosis 28.90 15.08 75 54912 14369 29505171
Blood cholesterol abnormal 28.89 15.08 23 54964 1435 29518105
Coronary artery disease 28.66 15.08 24 54963 44166 29475374
Polyarthritis 28.61 15.08 36 54951 3909 29515631
Abdominal discomfort 28.37 15.08 169 54818 47734 29471806
Pulmonary toxicity 28.36 15.08 40 54947 4850 29514690
Renal failure 27.86 15.08 340 54647 118259 29401281
Lymphoedema 27.73 15.08 33 54954 3384 29516156
Septic shock 27.69 15.08 46 54941 62514 29457026
Surgery 27.63 15.08 65 54922 11714 29507826
Metabolic acidosis 27.60 15.08 18 54969 37644 29481896
Lacrimal disorder 27.58 15.08 13 54974 310 29519230
Product use in unapproved indication 27.54 15.08 77 54910 86798 29432742
Multiple organ dysfunction syndrome 27.39 15.08 47 54940 63069 29456471
Coma 27.38 15.08 20 54967 39430 29480110
Pancreatitis acute 27.22 15.08 6 54981 24379 29495161
Respiratory distress 26.90 15.08 13 54974 32093 29487447
Psoriasis 26.87 15.08 125 54862 32102 29487438
Blood pressure decreased 26.76 15.08 27 54960 45450 29474090
Depressed level of consciousness 26.60 15.08 18 54969 36924 29482616
Wrist deformity 26.37 15.08 13 54974 343 29519197
Speech disorder 25.82 15.08 6 54981 23510 29496030
Hepatic enzyme abnormal 25.77 15.08 26 54961 2216 29517324
Respiratory arrest 25.71 15.08 8 54979 25825 29493715
Dactylitis 25.58 15.08 16 54971 678 29518862
Intestinal obstruction 25.41 15.08 3 54984 19274 29500266
Hypocalcaemia 25.38 15.08 4 54983 20661 29498879
Fatigue 25.24 15.08 426 54561 316395 29203145
Vasculitic rash 24.77 15.08 17 54970 844 29518696
Dysphagia 24.67 15.08 40 54947 54886 29464654
Chest pain 24.42 15.08 116 54871 111857 29407683
Thrombosis 24.31 15.08 150 54837 42895 29476645
Heart block congenital 24.23 15.08 7 54980 37 29519503
Aortic bruit 24.10 15.08 10 54977 174 29519366
Diarrhoea 24.08 15.08 455 54532 332243 29187297
Oedema 23.86 15.08 24 54963 40459 29479081
Pulmonary cavitation 23.81 15.08 16 54971 767 29518773
Elbow operation 23.73 15.08 9 54978 122 29519418
Irritability 23.64 15.08 6 54981 22146 29497394
Blood pressure fluctuation 23.57 15.08 86 54901 19808 29499732
Subdural haematoma 23.57 15.08 3 54984 18190 29501350
Toxic epidermal necrolysis 23.50 15.08 3 54984 18150 29501390
Oral disorder 23.46 15.08 32 54955 3761 29515779
Cutaneous symptom 23.31 15.08 11 54976 263 29519277
Cytomegalovirus viraemia 23.26 15.08 42 54945 6278 29513262
Disorientation 23.17 15.08 13 54974 29502 29490038
Bursitis 22.96 15.08 36 54951 4796 29514744
Generalised tonic-clonic seizure 22.85 15.08 4 54983 19135 29500405
Melaena 22.71 15.08 15 54972 31161 29488379
Dysgeusia 22.60 15.08 7 54980 22667 29496873
Fibromyalgia 22.35 15.08 26 54961 2603 29516937
Asthenia 22.17 15.08 275 54712 214975 29304565
Localised infection 21.98 15.08 66 54921 13750 29505790
Restlessness 21.78 15.08 7 54980 22138 29497402
Cardiac failure 21.78 15.08 75 54912 79212 29440328
Wrong technique in product usage process 21.73 15.08 16 54971 31412 29488128
Cerebral haemorrhage 21.72 15.08 16 54971 31410 29488130
Haematoma 21.69 15.08 8 54979 23204 29496336
C-reactive protein decreased 21.62 15.08 20 54967 1531 29518009
Foetal exposure during pregnancy 21.22 15.08 19 54968 33848 29485692
Splenic embolism 21.16 15.08 9 54978 167 29519373
Hepatic enzyme increased 21.15 15.08 121 54866 33678 29485862
Arthritis bacterial 21.14 15.08 33 54954 4380 29515160
Cytomegalovirus syndrome 21.06 15.08 8 54979 109 29519431
Red blood cell sedimentation rate 20.99 15.08 13 54974 541 29518999
Unevaluable event 20.89 15.08 15 54972 29836 29489704
Impaired healing 20.85 15.08 64 54923 13494 29506046
Soft tissue inflammation 20.83 15.08 7 54980 65 29519475
Ossicle disorder 20.72 15.08 6 54981 32 29519508
Steatorrhoea 20.67 15.08 14 54973 680 29518860
Injury 20.63 15.08 5 54982 19041 29500499
Arthrodesis 20.60 15.08 12 54975 446 29519094
Chills 20.58 15.08 66 54921 71234 29448306
Accidental overdose 20.31 15.08 4 54983 17589 29501951
White blood cell count increased 20.17 15.08 24 54963 37492 29482048
Spina bifida occulta 20.07 15.08 5 54982 13 29519527
Diffuse idiopathic skeletal hyperostosis 19.99 15.08 6 54981 37 29519503
Retinal scar 19.94 15.08 10 54977 274 29519266
Full blood count decreased 19.86 15.08 3 54984 15989 29503551
Haematocrit decreased 19.77 15.08 15 54972 29007 29490533
Cell-mediated cytotoxicity 19.59 15.08 6 54981 40 29519500
Fracture 19.50 15.08 38 54949 6015 29513525
Sideroblastic anaemia 19.31 15.08 9 54978 209 29519331
Cartilage injury 19.30 15.08 12 54975 503 29519037
Vision blurred 19.24 15.08 28 54959 40148 29479392
Orthostatic hypotension 19.20 15.08 9 54978 22620 29496920
Lethargy 19.20 15.08 25 54962 37555 29481985
Liver disorder 19.14 15.08 102 54885 27647 29491893
Granuloma skin 19.13 15.08 13 54974 635 29518905
Ventricular tachycardia 19.12 15.08 9 54978 22565 29496975
Tender joint count increased 18.98 15.08 6 54981 45 29519495
Stent placement 18.98 15.08 31 54956 4275 29515265
Acute respiratory failure 18.83 15.08 13 54974 26389 29493151
Motor dysfunction 18.83 15.08 37 54950 5893 29513647
Erythema 18.72 15.08 219 54768 75387 29444153
Rash maculo-papular 18.64 15.08 11 54976 24278 29495262
Lupus-like syndrome 18.61 15.08 22 54965 2240 29517300
Dyskinesia 18.60 15.08 7 54980 20054 29499486
Tooth extraction 18.57 15.08 30 54957 4099 29515441
Dermatitis psoriasiform 18.49 15.08 16 54971 1122 29518418
Neck pain 18.48 15.08 84 54903 21363 29498177
Cardiac granuloma 18.39 15.08 4 54983 4 29519536
COVID-19 18.35 15.08 24 54963 35990 29483550
Shoulder arthroplasty 18.34 15.08 11 54976 432 29519108
Paternal drugs affecting foetus 18.32 15.08 6 54981 51 29519489
Dental caries 18.30 15.08 30 54957 4150 29515390
Therapy non-responder 18.26 15.08 109 54878 30802 29488738
Hypervolaemia 18.25 15.08 5 54982 17540 29502000
Oral pustule 18.10 15.08 9 54978 242 29519298
Histoplasmosis 17.97 15.08 17 54970 1339 29518201
Arrhythmia 17.96 15.08 19 54968 31294 29488246
Vitamin B1 decreased 17.93 15.08 9 54978 247 29519293
Head injury 17.86 15.08 4 54983 16077 29503463
Gastric disorder 17.85 15.08 52 54935 10652 29508888
Epilepsy 17.82 15.08 6 54981 18426 29501114
Alanine aminotransferase increased 17.79 15.08 206 54781 70738 29448802
Erythema elevatum diutinum 17.70 15.08 5 54982 24 29519516
Otospondylomegaepiphyseal dysplasia 17.69 15.08 7 54980 107 29519433
Ejection fraction decreased 17.69 15.08 4 54983 15974 29503566
Hernia pain 17.61 15.08 9 54978 257 29519283
Aphthous ulcer 17.54 15.08 29 54958 4039 29515501
Latent tuberculosis 17.43 15.08 15 54972 1044 29518496
Hypertension 17.37 15.08 309 54678 116305 29403235
C-reactive protein 17.29 15.08 7 54980 114 29519426
Tuberculosis 17.19 15.08 40 54947 7156 29512384
Exposure via father 17.18 15.08 7 54980 116 29519424
Drug withdrawal syndrome 17.14 15.08 6 54981 17978 29501562
Diaphragmatic injury 16.80 15.08 7 54980 123 29519417
Stress ulcer 16.56 15.08 6 54981 71 29519469
Pulmonary granuloma 16.39 15.08 16 54971 1310 29518230
Blood parathyroid hormone decreased 16.33 15.08 13 54974 811 29518729
Central nervous system infection 16.30 15.08 11 54976 531 29519009
Full blood count abnormal 16.15 15.08 4 54983 15009 29504531
Human polyomavirus infection 16.10 15.08 12 54975 679 29518861
Acute myocardial infarction 16.04 15.08 42 54945 48396 29471144
Drug reaction with eosinophilia and systemic symptoms 16.04 15.08 17 54970 27975 29491565
Memory impairment 15.96 15.08 27 54960 36443 29483097
Haemoptysis 15.94 15.08 20 54967 30530 29489010
Chronic kidney disease 15.90 15.08 27 54960 36389 29483151
Lymphocyte count decreased 15.84 15.08 8 54979 19263 29500277
Granulomatous dermatitis 15.79 15.08 8 54979 224 29519316
Dysphonia 15.73 15.08 8 54979 19188 29500352
Single functional kidney 15.71 15.08 6 54981 83 29519457
Erectile dysfunction 15.53 15.08 7 54980 18002 29501538
Sensitivity to weather change 15.48 15.08 16 54971 1403 29518137
Anaphylactic shock 15.46 15.08 3 54984 13333 29506207
Cerebral infarction 15.27 15.08 14 54973 24661 29494879
Altered state of consciousness 15.27 15.08 9 54978 19880 29499660
Mycobacterial infection 15.18 15.08 18 54969 1838 29517702
Ileus 15.18 15.08 4 54983 14398 29505142

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
Drug ineffective 6678.58 13.12 12218 257126 828029 63401359
Drug intolerance 5186.07 13.12 5059 264285 182933 64046455
Joint swelling 4206.65 13.12 4824 264520 210558 64018830
Rheumatoid arthritis 4000.78 13.12 4135 265209 160159 64069229
Contraindicated product administered 3484.58 13.12 3172 266172 104657 64124731
Synovitis 3183.64 13.12 2906 266438 96184 64133204
Treatment failure 2861.62 13.12 2952 266392 113864 64115524
Arthropathy 2395.52 13.12 2733 266611 118234 64111154
Therapeutic product effect decreased 2084.63 13.12 2487 266857 112864 64116524
Arthralgia 1557.01 13.12 4705 264639 437555 63791833
Swelling 1431.17 13.12 2470 266874 157748 64071640
Pain 1430.57 13.12 5305 264039 548206 63681182
Hand deformity 1397.32 13.12 1509 267835 61262 64168126
C-reactive protein abnormal 1285.36 13.12 1025 268319 28022 64201366
Abdominal discomfort 1225.01 13.12 2488 266856 179834 64049554
Drug hypersensitivity 1213.02 13.12 2905 266439 234910 63994478
Pemphigus 1207.52 13.12 1376 267968 59325 64170063
Death 1151.67 13.12 299 269045 482406 63746982
Anti-cyclic citrullinated peptide antibody positive 1135.47 13.12 1210 268134 48352 64181036
Peripheral swelling 1130.61 13.12 2614 266730 206539 64022849
Rheumatoid factor positive 1124.51 13.12 1027 268317 33911 64195477
Systemic lupus erythematosus 1118.77 13.12 1496 267848 76116 64153272
Alopecia 1104.44 13.12 2254 267090 163436 64065952
Musculoskeletal stiffness 1080.64 13.12 1885 267459 121321 64108067
Acute kidney injury 1056.78 13.12 286 269058 448954 63780434
Hepatic enzyme increased 1017.04 13.12 1892 267452 128051 64101337
Therapeutic product effect incomplete 1003.63 13.12 1656 267688 101826 64127562
Glossodynia 995.70 13.12 1288 268056 63408 64165980
Hypersensitivity 955.32 13.12 2357 266987 194095 64035293
Red blood cell sedimentation rate abnormal 930.66 13.12 670 268674 15636 64213752
Completed suicide 845.64 13.12 19 269325 224395 64004993
Hypotension 843.52 13.12 271 269073 380703 63848685
Loss of personal independence in daily activities 793.59 13.12 1226 268118 71228 64158160
Toxicity to various agents 789.91 13.12 267 269077 363246 63866142
Pericarditis 774.97 13.12 1121 268223 61395 64167993
Drug interaction 702.45 13.12 317 269027 361766 63867622
Bone erosion 699.84 13.12 493 268851 11102 64218286
Rash 678.04 13.12 3730 265614 454819 63774569
Red blood cell sedimentation rate increased 677.33 13.12 741 268603 30494 64198894
Wound 665.97 13.12 1167 268177 75310 64154078
Febrile neutropenia 650.36 13.12 32 269312 187625 64041763
Infection 631.38 13.12 1950 267394 182930 64046458
Anaemia 608.37 13.12 419 268925 378261 63851127
Gastrointestinal disorder 605.89 13.12 1228 268116 88481 64140907
Psoriatic arthropathy 600.03 13.12 819 268525 42462 64186926
Helicobacter infection 560.88 13.12 745 268599 37617 64191771
Infusion related reaction 537.70 13.12 1709 267635 162758 64066630
Sleep disorder due to general medical condition, insomnia type 529.64 13.12 600 268744 25670 64203718
C-reactive protein increased 524.70 13.12 1198 268146 93711 64135677
Discomfort 521.20 13.12 1086 268258 79792 64149596
Constipation 507.24 13.12 163 269181 229174 64000214
Duodenal ulcer perforation 505.53 13.12 672 268672 33953 64195435
Impaired healing 488.20 13.12 893 268451 59580 64169808
Dehydration 486.63 13.12 150 269194 216613 64012775
Lower respiratory tract infection 483.39 13.12 1158 268186 93456 64135932
Mobility decreased 482.77 13.12 1091 268253 84749 64144639
Overdose 467.43 13.12 58 269286 159508 64069880
Irritable bowel syndrome 465.72 13.12 672 268672 36697 64192691
Condition aggravated 463.68 13.12 2897 266447 369529 63859859
Muscle injury 461.75 13.12 561 268783 25876 64203512
Rheumatoid nodule 460.78 13.12 399 268945 12252 64217136
Osteoarthritis 460.04 13.12 894 268450 62442 64166946
Malignant neoplasm progression 453.58 13.12 3 269341 112868 64116520
Folliculitis 444.10 13.12 587 268757 29490 64199898
Cardiac arrest 429.99 13.12 65 269279 153999 64075389
Sinusitis 407.27 13.12 1438 267906 144490 64084898
Hyponatraemia 406.24 13.12 66 269278 148273 64081115
Bradycardia 403.65 13.12 22 269322 118197 64111191
Arthritis 395.35 13.12 995 268349 82819 64146569
Thrombocytopenia 394.42 13.12 222 269122 223579 64005809
Disability 391.84 13.12 358 268986 11814 64217574
Seizure 390.08 13.12 107 269237 166785 64062603
Ill-defined disorder 375.25 13.12 666 268678 43386 64186002
Knee arthroplasty 371.26 13.12 509 268835 26490 64202898
Stomatitis 348.87 13.12 1129 268215 108476 64120912
Somnolence 346.07 13.12 211 269133 203434 64025954
Hyperkalaemia 341.61 13.12 20 269324 101109 64128279
Neutropenia 337.78 13.12 302 269042 239322 63990066
Intentional overdose 333.27 13.12 9 269335 89935 64139453
Maternal exposure during pregnancy 323.72 13.12 1008 268336 94876 64134512
Tremor 322.92 13.12 108 269236 148122 64081266
Dizziness 315 13.12 846 268498 429317 63800071
Dyspnoea 310.72 13.12 1749 267595 716925 63512463
Inflammation 309.76 13.12 777 268567 64523 64164865
Drug eruption 308.63 13.12 547 268797 35589 64193799
Tenosynovitis 301.48 13.12 306 269038 11527 64217861
Foot deformity 300.91 13.12 358 268986 16146 64213242
Product use issue 299.00 13.12 1341 268003 150374 64079014
Disease progression 295.33 13.12 111 269233 141569 64087819
Musculoskeletal disorder 294.98 13.12 369 268975 17537 64211851
Atrial fibrillation 292.42 13.12 176 269168 170913 64058475
Drug tolerance decreased 290.46 13.12 238 269106 6760 64222628
Osteoporosis 288.61 13.12 580 268764 41500 64187888
Cardio-respiratory arrest 277.96 13.12 40 269304 98353 64131035
Hip arthroplasty 277.81 13.12 392 268952 20959 64208429
Hypokalaemia 270.47 13.12 86 269258 121817 64107571
Fall 270.10 13.12 868 268476 415958 63813430
Granuloma skin 267.81 13.12 214 269130 5860 64223528
Electrocardiogram QT prolonged 267.45 13.12 16 269328 79432 64149956
Blister 265.74 13.12 843 268501 80124 64149264
Rhabdomyolysis 264.52 13.12 35 269309 91691 64137697
Blood parathyroid hormone decreased 263.56 13.12 230 269114 7136 64222252
Fibromyalgia 254.06 13.12 500 268844 35231 64194157
Joint range of motion decreased 252.96 13.12 356 268988 18987 64210401
Tachycardia 248.49 13.12 159 269185 149420 64079968
Cardiac failure congestive 242.46 13.12 121 269223 130459 64098929
Panniculitis 241.65 13.12 238 269106 8641 64220747
Respiratory failure 239.43 13.12 193 269151 160990 64068398
Depressed level of consciousness 237.41 13.12 30 269314 81406 64147982
Platelet count decreased 234.26 13.12 213 269131 167498 64061890
Hypoglycaemia 233.02 13.12 46 269298 89846 64139542
Joint stiffness 232.76 13.12 439 268905 29965 64199423
Agitation 231.64 13.12 44 269300 88323 64141065
Therapeutic response decreased 229.92 13.12 604 268740 51584 64177804
Pyrexia 221.68 13.12 1396 267948 557248 63672140
Suicide attempt 217.44 13.12 22 269322 70985 64158403
Abdominal pain 216.05 13.12 631 268713 311744 63917644
Cerebrovascular accident 210.32 13.12 160 269184 137423 64091965
Pneumonia aspiration 208.79 13.12 9 269335 59262 64170126
Nasopharyngitis 206.29 13.12 1464 267880 194609 64034779
Sepsis 206.27 13.12 406 268938 229935 63999453
Cardiac failure 206.13 13.12 151 269193 132222 64097166
Gastrointestinal haemorrhage 205.95 13.12 151 269193 132161 64097227
Decreased appetite 205.00 13.12 554 268790 280735 63948653
Pain in extremity 204.92 13.12 2049 267295 301036 63928352
International normalised ratio increased 204.17 13.12 41 269303 79126 64150262
Anxiety 202.23 13.12 334 269010 202315 64027073
Hallucination 200.06 13.12 32 269312 72756 64156632
Metabolic acidosis 200.05 13.12 29 269315 70929 64158459
Lactic acidosis 198.97 13.12 15 269329 61395 64167993
Syncope 198.62 13.12 219 269125 157416 64071972
Mental status changes 195.19 13.12 16 269328 61146 64168242
Neutrophil count decreased 194.92 13.12 42 269302 77154 64152234
Oedema peripheral 194.15 13.12 364 268980 209953 64019435
Hypoxia 188.84 13.12 66 269278 88083 64141305
Adverse event 188.39 13.12 471 268873 39018 64190370
Enthesopathy 185.55 13.12 215 269129 9423 64219965
Vomiting 184.80 13.12 1446 267898 549671 63679717
Blood cholesterol increased 184.53 13.12 543 268801 49523 64179865
Respiratory arrest 183.53 13.12 9 269335 52976 64176412
Finger deformity 179.67 13.12 159 269185 5027 64224361
Rheumatoid lung 179.53 13.12 118 269226 2361 64227027
Nodule 177.44 13.12 290 269054 17657 64211731
Vision blurred 176.40 13.12 78 269266 90238 64139150
Unresponsive to stimuli 176.36 13.12 8 269336 50385 64179003
Product dose omission issue 176.29 13.12 341 269003 194406 64034982
Hyperglycaemia 174.02 13.12 24 269320 60944 64168444
Adverse drug reaction 173.24 13.12 499 268845 44965 64184423
Liver function test increased 171.04 13.12 391 268953 30579 64198809
Chest pain 170.96 13.12 466 268878 235514 63993874
Coma 165.93 13.12 79 269265 87536 64141852
Impaired work ability 165.70 13.12 257 269087 14962 64214426
Rheumatoid factor negative 162.32 13.12 83 269261 1010 64228378
Apparent death 161.96 13.12 114 269230 2562 64226826
Sedation 158.03 13.12 3 269341 41459 64187929
Skin ulcer 157.37 13.12 472 268872 43502 64185886
Blood glucose increased 156.43 13.12 109 269235 97964 64131424
Neoplasm progression 155.99 13.12 3 269341 40961 64188427
Limb deformity 155.88 13.12 122 269222 3239 64226149
Urinary tract infection 151.31 13.12 480 268864 231116 63998272
Loss of consciousness 151.28 13.12 241 269103 148124 64081264
Aggression 150.61 13.12 11 269333 46221 64183167
Multiple organ dysfunction syndrome 148.59 13.12 123 269221 101290 64128098
Plasma cell myeloma 147.17 13.12 12 269332 46063 64183325
Chest discomfort 146.56 13.12 161 269183 115945 64113443
Pulmonary fibrosis 146.34 13.12 360 268984 29518 64199870
Dislocation of vertebra 146.19 13.12 114 269230 3010 64226378
Asthenia 146.16 13.12 1117 268227 426927 63802461
Serotonin syndrome 145.23 13.12 4 269340 39278 64190110
Dysarthria 144.62 13.12 35 269309 59371 64170017
Swollen joint count increased 142.16 13.12 168 269176 7521 64221867
Oral mucosal exfoliation 140.68 13.12 82 269262 1313 64228075
Tuberculin test positive 139.34 13.12 110 269234 2958 64226430
Musculoskeletal pain 138.40 13.12 689 268655 80605 64148783
Balance disorder 136.89 13.12 91 269253 83835 64145553
Skin necrosis 135.55 13.12 227 269117 14102 64215286
Cognitive disorder 134.99 13.12 32 269312 55055 64174333
Cerebral haemorrhage 134.81 13.12 25 269319 51065 64178323
Urinary retention 134.37 13.12 22 269322 49179 64180209
Blood creatine phosphokinase increased 134.02 13.12 39 269305 58519 64170869
White blood cell count decreased 133.76 13.12 287 269057 157550 64071838
Breast cancer stage III 133.76 13.12 105 269239 2800 64226588
Rheumatic fever 133.48 13.12 179 269165 9115 64220273
Blood pressure decreased 133.29 13.12 99 269245 86100 64143288
Ankylosing spondylitis 131.34 13.12 167 269177 8067 64221321
Respiratory distress 131.03 13.12 29 269315 52302 64177086
Septic shock 130.02 13.12 149 269195 105288 64124100
Intentional product misuse 129.69 13.12 70 269274 72225 64157163
Lethargy 129.19 13.12 71 269273 72523 64156865
Urticaria 128.50 13.12 1053 268291 146264 64083124
Myalgia 128.21 13.12 296 269048 158321 64071067
Disorientation 128.10 13.12 37 269307 55791 64173597
Encephalopathy 127.77 13.12 43 269301 58776 64170612
Pleural effusion 126.73 13.12 208 269136 126351 64103037
Joint laxity 125.00 13.12 92 269252 2222 64227166
Pulmonary embolism 124.95 13.12 265 269079 146091 64083297
Melaena 123.77 13.12 35 269309 53513 64175875
Grip strength decreased 123.49 13.12 195 269149 11529 64217859
Musculoskeletal deformity 121.97 13.12 58 269286 596 64228792
Hypomagnesaemia 121.44 13.12 9 269335 37367 64192021
Orthostatic hypotension 120.93 13.12 24 269320 46714 64182674
Pulmonary oedema 120.82 13.12 91 269253 78583 64150805
Haemoglobin decreased 120.68 13.12 414 268930 194649 64034739
Haemorrhage 119.04 13.12 94 269250 79257 64150131
Abnormal behaviour 118.76 13.12 5 269339 33617 64195771
Haematuria 118.43 13.12 52 269292 60419 64168969
Restlessness 117.55 13.12 14 269330 39771 64189617
Ascites 117.25 13.12 56 269288 61945 64167443
Hypervolaemia 116.84 13.12 12 269332 38273 64191115
Renal failure 116.23 13.12 380 268964 181308 64048080
Sleep disorder 116.13 13.12 526 268818 59183 64170205
Ulcer 115.78 13.12 280 269064 22710 64206678
Drug reaction with eosinophilia and systemic symptoms 115.41 13.12 41 269303 54176 64175212
Seronegative arthritis 115.33 13.12 94 269250 2649 64226739
Blood creatinine increased 114.12 13.12 248 269096 135534 64093854
Pancytopenia 113.75 13.12 270 269074 143039 64086349
Alanine aminotransferase abnormal 113.52 13.12 142 269202 6746 64222642
Physical disability 112.64 13.12 86 269258 2199 64227189
Acute myocardial infarction 111.82 13.12 77 269267 69641 64159747
Disturbance in attention 110.76 13.12 19 269325 41055 64188333
Confusional state 109.82 13.12 640 268704 260504 63968884
Wrong technique in product usage process 107.93 13.12 69 269275 64905 64164483
Joint arthroplasty 107.71 13.12 80 269264 1960 64227428
Deformity 107.28 13.12 132 269212 6165 64223223
Intentional self-injury 107.21 13.12 3 269341 29041 64200347
Sciatica 106.58 13.12 251 269093 20013 64209375
Palmar-plantar erythrodysaesthesia syndrome 106.30 13.12 3 269341 28816 64200572
Altered state of consciousness 105.65 13.12 16 269328 37886 64191502
Coronary artery disease 103.40 13.12 62 269282 60371 64169017
Dysphagia 102.83 13.12 180 269164 106632 64122756
Ear pain 102.71 13.12 283 269061 24853 64204535
Generalised tonic-clonic seizure 102.01 13.12 21 269323 39836 64189552
Drug level increased 101.11 13.12 12 269332 34184 64195204
Pancreatitis acute 100.94 13.12 27 269317 42828 64186560
Renal impairment 100.43 13.12 263 269081 134754 64094634
Chills 100.12 13.12 270 269074 136994 64092394
Joint destruction 99.94 13.12 98 269246 3538 64225850
Rectal haemorrhage 99.50 13.12 68 269276 61749 64167639
Fine motor skill dysfunction 99.26 13.12 110 269234 4589 64224799
Ventricular tachycardia 98.94 13.12 13 269331 34252 64195136
Hallucination, visual 98.78 13.12 4 269340 27830 64201558
Hyperhidrosis 98.62 13.12 236 269108 124684 64104704
Haematoma 98.40 13.12 35 269309 46215 64183173
Femur fracture 97.31 13.12 339 269005 33796 64195592
Loose body in joint 95.64 13.12 61 269283 1157 64228231
Product use in unapproved indication 95.49 13.12 396 268948 176222 64053166
Psychotic disorder 95.46 13.12 15 269329 34563 64194825
Diverticulitis 95.31 13.12 366 268978 38252 64191136
Drug withdrawal syndrome 95.00 13.12 10 269334 31281 64198107
Surgical failure 94.15 13.12 52 269292 747 64228641
Joint effusion 93.90 13.12 187 269157 13286 64216102
Flushing 93.89 13.12 114 269230 78534 64150854
Arthrodesis 93.64 13.12 74 269270 1993 64227395
Epilepsy 91.55 13.12 15 269329 33516 64195872
Fluid retention 91.45 13.12 69 269275 59537 64169851
Cerebral infarction 90.91 13.12 29 269315 41015 64188373
Red blood cell sedimentation rate 90.89 13.12 94 269250 3620 64225768
Dyskinesia 90.56 13.12 26 269318 39362 64190026
Lymphocyte count decreased 89.72 13.12 29 269315 40670 64188718
Adverse reaction 89.60 13.12 134 269210 7553 64221835
Shoulder arthroplasty 87.81 13.12 80 269264 2629 64226759
Chronic kidney disease 87.64 13.12 68 269276 57851 64171537
Joint injury 87.53 13.12 252 269092 22695 64206693
Intervertebral disc space narrowing 86.98 13.12 60 269284 1304 64228084
Hypocalcaemia 86.46 13.12 33 269311 41720 64187668
Toxic epidermal necrolysis 86.44 13.12 24 269320 37142 64192246
Pneumonia 85.53 13.12 1736 267608 557840 63671548
Delirium 85.05 13.12 98 269246 69096 64160292
COVID-19 84.77 13.12 88 269256 65052 64164336
Haemoptysis 84.36 13.12 50 269294 48998 64180390
Acute respiratory failure 84.35 13.12 52 269292 49882 64179506
Foot operation 84.09 13.12 96 269248 4139 64225249
Cardiac disorder 83.86 13.12 66 269278 55750 64173638
Urinary incontinence 82.86 13.12 24 269320 36127 64193261
Muscle spasticity 82.85 13.12 202 269142 16467 64212921
Wrist deformity 82.75 13.12 65 269279 1735 64227653
Subdural haematoma 82.57 13.12 10 269334 28044 64201344
Atlantoaxial instability 82.25 13.12 35 269309 270 64229118
Sinus bradycardia 82.23 13.12 3 269341 22890 64206498
Mineral metabolism disorder 81.37 13.12 35 269309 278 64229110
Accidental overdose 81.22 13.12 20 269324 33537 64195851
Night sweats 81.20 13.12 332 269012 35714 64193674
Gastric disorder 80.67 13.12 287 269057 28910 64200478
Aphasia 80.37 13.12 35 269309 40871 64188517
Arrhythmia 80.31 13.12 62 269282 52882 64176506
Ejection fraction decreased 80.28 13.12 12 269332 28695 64200693
Diabetic ketoacidosis 80.05 13.12 14 269330 29831 64199557
Basal cell carcinoma 80.02 13.12 297 269047 30541 64198847
Circulatory collapse 79.92 13.12 21 269323 33711 64195677
Inappropriate antidiuretic hormone secretion 79.79 13.12 3 269341 22286 64207102
Poisoning 78.13 13.12 3 269341 21876 64207512
Bone density abnormal 77.35 13.12 75 269269 2670 64226718
Sensitivity to weather change 76.78 13.12 116 269228 6598 64222790
Spinal instability 75.85 13.12 35 269309 334 64229054
Limb discomfort 75.83 13.12 268 269076 26907 64202481
Tendonitis 75.69 13.12 221 269123 20061 64209327
Blood calcium decreased 75.47 13.12 9 269335 25545 64203843
Dysgeusia 75.38 13.12 52 269292 46995 64182393
Fatigue 75.31 13.12 3833 265511 744897 63484491
Bone disorder 74.83 13.12 195 269149 16564 64212824
Blood urea increased 74.55 13.12 46 269298 44107 64185281
Haemorrhage intracranial 74.16 13.12 7 269337 23877 64205511
Cholestasis 74.05 13.12 48 269296 44824 64184564
Bone swelling 74.01 13.12 52 269292 1165 64228223
Tongue disorder 74.00 13.12 159 269185 11921 64217467
Intentional product use issue 73.83 13.12 664 268680 94700 64134688
Product quality issue 73.62 13.12 17 269327 29782 64199606
Blood bilirubin increased 73.49 13.12 79 269265 57474 64171914
Haematochezia 73.26 13.12 102 269242 66271 64163117
Dyspnoea exertional 73.02 13.12 122 269222 73608 64155780
Sinus tachycardia 72.62 13.12 22 269322 32166 64197222
Presyncope 72.22 13.12 28 269316 35061 64194327
Hospitalisation 72.14 13.12 127 269217 75080 64154308
Clostridium difficile colitis 70.38 13.12 14 269330 27209 64202179
Cardiogenic shock 69.91 13.12 24 269320 32403 64196985
Respiratory depression 69.88 13.12 8 269336 23435 64205953
Labelled drug-drug interaction medication error 69.76 13.12 6 269338 22056 64207332
Ankle deformity 69.70 13.12 40 269304 621 64228767
Neutropenic sepsis 69.22 13.12 8 269336 23264 64206124
Blood iron abnormal 69.05 13.12 49 269295 1116 64228272
Tumour lysis syndrome 68.30 13.12 3 269341 19437 64209951
Transient ischaemic attack 67.96 13.12 51 269293 44131 64185257
Contusion 67.64 13.12 751 268593 113214 64116174
Withdrawal syndrome 67.62 13.12 9 269335 23483 64205905
Abdominal distension 67.61 13.12 192 269152 95802 64133586
Renal tubular necrosis 67.29 13.12 7 269337 22103 64207285
Oxygen saturation decreased 67.23 13.12 226 269118 106950 64122438
Myoclonus 66.89 13.12 12 269332 25106 64204282
Spinal column injury 66.60 13.12 58 269286 1794 64227594
Full blood count decreased 66.58 13.12 8 269336 22574 64206814
Upper gastrointestinal haemorrhage 66.30 13.12 32 269312 35188 64194200
Hemiparesis 66.19 13.12 21 269323 29806 64199582
Terminal state 65.98 13.12 87 269257 4357 64225031
Ileus 65.62 13.12 9 269335 22957 64206431
Retinal toxicity 65.43 13.12 50 269294 1280 64228108
Dysuria 65.39 13.12 48 269296 42009 64187379
Acute myeloid leukaemia 65.25 13.12 17 269327 27446 64201942
Neuropathy peripheral 64.43 13.12 262 269082 117263 64112125
Hypothermia 63.89 13.12 5 269339 19851 64209537
Irritability 63.84 13.12 37 269307 36709 64192679
Exostosis 63.80 13.12 145 269199 11293 64218095
Body temperature increased 63.25 13.12 312 269032 36354 64193034
Agranulocytosis 62.94 13.12 41 269303 38188 64191200
Intestinal sepsis 62.80 13.12 37 269307 605 64228783
Gastrointestinal pain 62.53 13.12 113 269231 7461 64221927
Neck deformity 62.34 13.12 54 269290 1658 64227730
Depressed mood 62.24 13.12 48 269296 40964 64188424
Premature delivery 61.77 13.12 4 269340 18585 64210803
Deafness transitory 61.61 13.12 40 269304 783 64228605
Suicidal ideation 61.47 13.12 115 269229 66427 64162961
Small intestinal obstruction 61.20 13.12 12 269332 23561 64205827
Mouth ulceration 60.98 13.12 283 269061 32161 64197227
Status epilepticus 60.71 13.12 9 269335 21654 64207734
Infusion site reaction 60.68 13.12 58 269286 2028 64227360
Dystonia 60.00 13.12 5 269339 18860 64210528
Torsade de pointes 59.96 13.12 3 269341 17360 64212028
Eosinophilia 59.80 13.12 43 269301 38033 64191355
Intestinal obstruction 59.62 13.12 39 269305 36247 64193141
Sudden death 59.54 13.12 7 269337 20089 64209299
Haematemesis 59.47 13.12 65 269279 46934 64182454
Pallor 59.35 13.12 45 269299 38736 64190652
Thyroid neoplasm 59.25 13.12 64 269280 2593 64226795
Blood potassium decreased 59.15 13.12 49 269295 40350 64189038
Dry skin 59.13 13.12 76 269268 51085 64178303
Spinal stenosis 59.06 13.12 159 269185 13772 64215616
Hyperbilirubinaemia 58.99 13.12 9 269335 21196 64208192
Exposure during pregnancy 58.67 13.12 538 268806 77137 64152251
Hepatic encephalopathy 58.46 13.12 9 269335 21057 64208331
Myocardial infarction 58.19 13.12 429 268915 165392 64063996
Ovarian neoplasm 58.08 13.12 34 269310 549 64228839
Angioedema 57.85 13.12 106 269238 61715 64167673
Shock 57.72 13.12 45 269299 38195 64191193
Flatulence 57.70 13.12 39 269305 35627 64193761
Dementia 57.34 13.12 9 269335 20757 64208631
Herpes zoster 57.07 13.12 543 268801 78644 64150744
Pericardial effusion 57.00 13.12 48 269296 39206 64190182
International normalised ratio fluctuation 56.91 13.12 66 269278 2895 64226493
White blood cell count increased 56.75 13.12 119 269225 65895 64163493
Pulmonary hypertension 56.44 13.12 58 269286 43081 64186307
Asthma 56.24 13.12 206 269138 95019 64134369
Pancreatitis 55.96 13.12 102 269242 59505 64169883
Hepatic enzyme abnormal 55.89 13.12 93 269251 5746 64223642
Head injury 55.75 13.12 34 269310 32808 64196580
Bone pain 55.67 13.12 70 269274 47502 64181886
Bone marrow failure 55.66 13.12 71 269273 47881 64181507
Mania 55.65 13.12 3 269341 16283 64213105
Product administration error 55.35 13.12 23 269321 27620 64201768
Anuria 55.22 13.12 7 269337 18957 64210431
Blood sodium decreased 55.17 13.12 27 269317 29455 64199933
Mitral valve incompetence 54.88 13.12 19 269325 25519 64203869
Abdominal pain lower 54.67 13.12 21 269323 26448 64202940
Bacteraemia 54.52 13.12 22 269322 26889 64202499
Osteosclerosis 54.49 13.12 70 269274 3416 64225972
Bone cyst 54.48 13.12 56 269288 2141 64227247
Disseminated intravascular coagulation 54.20 13.12 34 269310 32314 64197074
X-ray abnormal 54.12 13.12 47 269297 1448 64227940
Injection site reaction 54.05 13.12 357 268987 46307 64183081
Systemic lupus erythematosus rash 54.03 13.12 46 269298 1379 64228009
Chronic obstructive pulmonary disease 53.88 13.12 137 269207 70911 64158477
Deep vein thrombosis 53.65 13.12 241 269103 104941 64124447
Multiple fractures 53.58 13.12 93 269251 5947 64223441
Chondropathy 53.12 13.12 57 269287 2292 64227096
Myopathy 52.78 13.12 6 269338 17674 64211714
Cutaneous vasculitis 52.71 13.12 96 269248 6377 64223011
Extremity contracture 52.69 13.12 48 269296 1577 64227811
Ventricular fibrillation 52.59 13.12 17 269327 23843 64205545
Leukocytosis 52.56 13.12 48 269296 37692 64191696
Sarcoidosis 52.41 13.12 93 269251 6053 64223335
Mycotic allergy 52.38 13.12 39 269305 959 64228429
Aspiration 52.29 13.12 5 269339 16880 64212508
Stevens-Johnson syndrome 52.08 13.12 40 269304 34209 64195179
Therapy cessation 51.93 13.12 36 269308 32453 64196935
Metastases to bone 51.81 13.12 11 269333 20424 64208964
Brain oedema 51.81 13.12 14 269330 22061 64207327
Pulmonary thrombosis 51.78 13.12 127 269217 10391 64218997
Vasculitic rash 51.65 13.12 52 269292 1939 64227449
Full blood count abnormal 51.64 13.12 30 269314 29727 64199661
Pulmonary mass 51.58 13.12 218 269126 23798 64205590
Synovial cyst 51.36 13.12 105 269239 7602 64221786
Mucosal inflammation 51.17 13.12 116 269228 62468 64166920
Fear of injection 51.11 13.12 90 269254 5822 64223566
Therapy non-responder 51.07 13.12 459 268885 65440 64163948
Dactylitis 50.98 13.12 51 269293 1887 64227501
Underdose 50.90 13.12 22 269322 25807 64203581
Device dislocation 50.52 13.12 13 269331 21165 64208223
Coordination abnormal 50.39 13.12 3 269341 14961 64214427
Haemodynamic instability 50.18 13.12 3 269341 14909 64214479
Secretion discharge 50.17 13.12 136 269208 11828 64217560
Hallucination, auditory 49.94 13.12 6 269338 16933 64212455
Oedema 49.73 13.12 206 269138 91729 64137659
Polyomavirus-associated nephropathy 49.69 13.12 80 269264 4808 64224580
Lupus-like syndrome 49.65 13.12 112 269232 8679 64220709
Muscle rigidity 49.57 13.12 7 269337 17466 64211922
Tuberculosis 49.55 13.12 143 269201 12895 64216493
Metastases to liver 49.44 13.12 19 269325 23922 64205466
Bronchitis chronic 49.38 13.12 71 269273 3861 64225527
Delusion 49.31 13.12 8 269336 18006 64211382
Electrolyte imbalance 48.96 13.12 22 269322 25221 64204167
Product prescribing error 48.95 13.12 45 269299 35224 64194164
Wrist surgery 48.53 13.12 33 269311 700 64228688
Acidosis 48.49 13.12 8 269336 17787 64211601
Creatinine renal clearance decreased 48.23 13.12 3 269341 14418 64214970
Localised infection 48.06 13.12 251 269093 29910 64199478
Injection site hypersensitivity 47.55 13.12 46 269298 1633 64227755
Type 2 diabetes mellitus 47.42 13.12 273 269071 33747 64195641
Osteoporotic fracture 46.71 13.12 66 269278 3532 64225856
Fracture delayed union 46.36 13.12 49 269295 1936 64227452
Supraventricular tachycardia 46.28 13.12 11 269333 18896 64210492
Mydriasis 46.21 13.12 5 269339 15307 64214081
Visual acuity reduced 46.20 13.12 28 269316 27113 64202275
Atrial flutter 46.04 13.12 12 269332 19368 64210020
Tachypnoea 45.81 13.12 27 269317 26544 64202844
Toxic skin eruption 45.69 13.12 12 269332 19272 64210116
Obstructive airways disorder 45.29 13.12 20 269324 23165 64206223
Anti-cyclic citrullinated peptide antibody 45.16 13.12 41 269303 1341 64228047
Gastrooesophageal reflux disease 45.16 13.12 186 269158 82957 64146431
Hair follicle tumour benign 45.01 13.12 26 269318 409 64228979
Extrapyramidal disorder 44.77 13.12 13 269331 19539 64209849
Incorrect dose administered 44.68 13.12 119 269225 60646 64168742
Electrocardiogram abnormal 44.51 13.12 3 269341 13478 64215910
Retinitis 44.37 13.12 49 269295 2036 64227352
Acute coronary syndrome 43.92 13.12 13 269331 19297 64210091
Haemodialysis 43.69 13.12 9 269335 17068 64212320
Device issue 43.51 13.12 20 269324 22628 64206760
Lower gastrointestinal haemorrhage 43.50 13.12 4 269340 13935 64215453
Cyanosis 43.45 13.12 19 269325 22136 64207252
Fear 43.36 13.12 15 269329 20156 64209232
Pustular psoriasis 43.26 13.12 69 269275 4114 64225274
Emotional distress 43.25 13.12 52 269292 35986 64193402
Weight increased 43.24 13.12 1182 268162 212166 64017222
Rash erythematous 43.22 13.12 86 269258 48547 64180841
Transaminases abnormal 42.97 13.12 31 269313 725 64228663
Face oedema 42.92 13.12 25 269319 24736 64204652
Pollakiuria 42.85 13.12 41 269303 31489 64197899
Bloody discharge 42.83 13.12 41 269303 1436 64227952
Atrioventricular block complete 42.77 13.12 5 269339 14413 64214975
Gastritis 42.67 13.12 70 269274 42548 64186840
Panic attack 42.66 13.12 17 269327 20936 64208452
Peritonitis 42.34 13.12 26 269318 24997 64204391
Polyarthritis 42.31 13.12 112 269232 9603 64219785
Drug use disorder 42.15 13.12 84 269260 5970 64223418
Renal injury 41.90 13.12 7 269337 15422 64213966
Oesophagitis 41.72 13.12 19 269325 21611 64207777
Cholelithiasis 41.71 13.12 79 269265 45427 64183961
Hypophagia 41.56 13.12 63 269281 39524 64189864
Angina pectoris 41.55 13.12 78 269266 45003 64184385
Hypophosphataemia 41.52 13.12 6 269338 14714 64214674
Left ventricular dysfunction 41.23 13.12 10 269334 16944 64212444
Allergic oedema 41.14 13.12 30 269314 714 64228674
Muscle twitching 41.06 13.12 14 269330 18984 64210404
Cardiac failure acute 41.03 13.12 9 269335 16335 64213053
Cardiomegaly 40.93 13.12 24 269320 23660 64205728
Multiple allergies 40.88 13.12 81 269263 5733 64223655
Demyelination 40.77 13.12 89 269255 6745 64222643
Carpal tunnel syndrome 40.69 13.12 152 269192 15676 64213712
Product substitution issue 40.67 13.12 12 269332 17849 64211539
Rash maculo-papular 40.22 13.12 85 269259 46941 64182447
Ataxia 40.16 13.12 21 269323 22063 64207325
Pemphigoid 39.81 13.12 4 269340 12982 64216406
Hepatic failure 39.58 13.12 110 269234 55284 64174104
Urine output decreased 39.58 13.12 10 269334 16482 64212906
Ventricular extrasystoles 39.51 13.12 12 269332 17517 64211871
Speech disorder 39.42 13.12 90 269254 48351 64181037
Cytology abnormal 39.41 13.12 22 269322 323 64229065
Transfusion 39.34 13.12 13 269331 17981 64211407
Tinnitus 39.14 13.12 51 269293 34082 64195306
Foot fracture 39.13 13.12 165 269179 17992 64211396
Acute generalised exanthematous pustulosis 39.03 13.12 6 269338 14052 64215336
Incontinence 38.99 13.12 3 269341 12078 64217310
Infiltration anaesthesia 38.79 13.12 17 269327 142 64229246
Atelectasis 38.78 13.12 34 269310 27232 64202156
Eye pain 38.63 13.12 45 269299 31580 64197808
Accidental exposure to product 38.57 13.12 32 269312 26332 64203056
Metastases to central nervous system 38.48 13.12 6 269338 13906 64215482
Blood magnesium decreased 38.45 13.12 6 269338 13899 64215489
Investigation abnormal 38.39 13.12 37 269307 1307 64228081
Drug ineffective for unapproved indication 38.35 13.12 44 269300 31089 64198299
Colitis 37.98 13.12 122 269222 58552 64170836
Blood glucose decreased 37.79 13.12 25 269319 23098 64206290
Labile blood pressure 37.71 13.12 45 269299 2035 64227353
Cough 37.64 13.12 967 268377 301181 63928207
Troponin increased 37.61 13.12 9 269335 15390 64213998
Cytomegalovirus infection 37.34 13.12 61 269283 37138 64192250
Diplopia 37.32 13.12 34 269310 26731 64202657
Osteopenia 37.29 13.12 146 269198 15394 64213994
Skin papilloma 37.20 13.12 73 269271 5130 64224258
Metastases to lung 37.13 13.12 9 269335 15255 64214133
Ischaemic stroke 36.90 13.12 40 269304 28995 64200393
Impaired gastric emptying 36.84 13.12 100 269244 8704 64220684
Tubulointerstitial nephritis 36.67 13.12 45 269299 30864 64198524
Mycobacterium tuberculosis complex test positive 36.64 13.12 44 269300 2003 64227385
Malnutrition 36.57 13.12 17 269327 19108 64210280
Immune thrombocytopenia 36.42 13.12 9 269335 15057 64214331
Mental disorder 36.39 13.12 34 269310 26411 64202977
Aplastic anaemia 36.32 13.12 7 269337 13913 64215475
Pruritus allergic 36.31 13.12 30 269314 862 64228526
Cellulitis 35.94 13.12 236 269108 93421 64135967
Ankle arthroplasty 35.90 13.12 30 269314 876 64228512
Diarrhoea 35.73 13.12 2568 266776 720136 63509252
Granuloma 35.73 13.12 83 269261 6558 64222830
Hypercalcaemia 35.57 13.12 239 269105 31177 64198211
Myocardial ischaemia 35.55 13.12 27 269317 23224 64206164
Pulmonary haemorrhage 35.48 13.12 6 269338 13103 64216285
Nocturia 35.40 13.12 3 269341 11162 64218226
Haemorrhoids 35.27 13.12 29 269315 23972 64205416
Hepatocellular injury 35.25 13.12 86 269258 45149 64184239
Skin exfoliation 35.24 13.12 85 269259 44800 64184588
Shock haemorrhagic 35.22 13.12 13 269331 16778 64212610
Heart rate increased 35.21 13.12 254 269090 98421 64130967
Myelodysplastic syndrome 35.05 13.12 38 269306 27541 64201847
Bronchopulmonary aspergillosis 34.92 13.12 18 269326 19067 64210321
Red cell distribution width decreased 34.89 13.12 32 269312 1061 64228327
Paraesthesia 34.87 13.12 376 268968 134146 64095242
Vascular access complication 34.76 13.12 32 269312 1066 64228322
Oliguria 34.67 13.12 9 269335 14567 64214821
Pulmonary toxicity 34.59 13.12 96 269248 8465 64220923
Joint dislocation 34.54 13.12 116 269228 11349 64218039
Colitis ischaemic 34.46 13.12 7 269337 13407 64215981
Myocarditis 34.41 13.12 14 269330 17029 64212359
Arteriosclerosis coronary artery 34.34 13.12 11 269333 15518 64213870
Nail disorder 34.14 13.12 96 269248 8528 64220860
Angina unstable 34.12 13.12 11 269333 15456 64213932
Wheezing 34.06 13.12 197 269147 80382 64149006
Pneumonia viral 33.89 13.12 90 269254 7732 64221656
C-reactive protein 33.86 13.12 30 269314 950 64228438
Arthritis bacterial 33.76 13.12 90 269254 7749 64221639
Erectile dysfunction 33.69 13.12 6 269338 12621 64216767
Emotional disorder 33.62 13.12 6 269338 12601 64216787
Nausea 33.57 13.12 2826 266518 782974 63446414
Latent tuberculosis 33.48 13.12 49 269295 2708 64226680
Hypermobility syndrome 33.45 13.12 23 269321 497 64228891
Tooth disorder 33.36 13.12 183 269161 22219 64207169
Hypoalbuminaemia 33.35 13.12 16 269328 17658 64211730
Lip swelling 33.28 13.12 51 269293 31856 64197532
Hypotonia 32.98 13.12 4 269340 11208 64218180
Device related infection 32.87 13.12 48 269296 30578 64198810
Psoriasis 32.79 13.12 450 268894 71253 64158135
Depression 32.74 13.12 553 268791 182738 64046650
Soft tissue disorder 32.46 13.12 53 269291 3223 64226165
Mean platelet volume decreased 32.29 13.12 38 269306 1693 64227695
Lower limb fracture 32.29 13.12 127 269217 13418 64215970
Joint space narrowing 32.26 13.12 17 269327 221 64229167
Blood loss anaemia 32.25 13.12 9 269335 13883 64215505
Spinal fusion surgery 32.11 13.12 56 269288 3595 64225793
Rash pruritic 32.11 13.12 374 268970 57030 64172358
Hyperthyroidism 32.02 13.12 18 269326 18161 64211227
Acute respiratory distress syndrome 31.96 13.12 72 269272 38863 64190525
Neck mass 31.70 13.12 59 269285 3985 64225403
Prothrombin time prolonged 31.67 13.12 13 269331 15728 64213660
Vertigo 31.43 13.12 133 269211 58878 64170510
Onychomycosis 31.38 13.12 68 269276 5128 64224260
Palpitations 31.29 13.12 282 269062 104206 64125182
Wound infection 31.20 13.12 134 269210 14730 64214658
Disease susceptibility 31.10 13.12 17 269327 239 64229149
Muscular weakness 30.99 13.12 361 268983 126977 64102411
Therapy interrupted 30.98 13.12 23 269321 20013 64209375
Lyme disease 30.91 13.12 44 269300 2371 64227017
Apathy 30.71 13.12 5 269339 11227 64218161
Psychomotor hyperactivity 30.63 13.12 11 269333 14440 64214948
Neutrophil count increased 30.56 13.12 36 269308 25138 64204250
Coagulopathy 30.51 13.12 54 269290 31866 64197522
Drug tolerance 30.51 13.12 74 269270 6011 64223377
Respiratory acidosis 30.30 13.12 3 269341 9852 64219536
Vaginal haemorrhage 30.17 13.12 22 269322 19322 64210066
Device difficult to use 30.08 13.12 3 269341 9795 64219593
Subarachnoid haemorrhage 30.04 13.12 20 269324 18418 64210970
Apnoea 29.98 13.12 4 269340 10418 64218970
Jaundice 29.93 13.12 103 269241 48409 64180979
Incorrect product administration duration 29.93 13.12 3 269341 9755 64219633
Failure to thrive 29.91 13.12 4 269340 10400 64218988
Memory impairment 29.88 13.12 222 269122 85460 64143928
Salivary hypersecretion 29.74 13.12 7 269337 12106 64217282
Tricuspid valve incompetence 29.71 13.12 17 269327 16986 64212402
Joint lock 29.69 13.12 47 269297 2784 64226604
Clostridium difficile infection 29.58 13.12 67 269277 36096 64193292
Drug level decreased 29.56 13.12 6 269338 11497 64217891
Eosinophil count increased 29.47 13.12 11 269333 14101 64215287
Bundle branch block right 29.40 13.12 4 269340 10265 64219123
Atrioventricular block 29.39 13.12 7 269337 12008 64217380
Gait disturbance 29.20 13.12 933 268411 171222 64058166
Skin discolouration 29.09 13.12 65 269279 35190 64194198
Mental impairment 29.04 13.12 16 269328 16327 64213061
Faeces discoloured 28.93 13.12 39 269305 25690 64203698
Gait inability 28.78 13.12 287 269057 42081 64187307
Mass excision 28.75 13.12 17 269327 280 64229108
Colitis microscopic 28.71 13.12 82 269262 7350 64222038
Coronary artery stenosis 28.63 13.12 6 269338 11242 64218146
Haematocrit decreased 28.60 13.12 124 269220 54531 64174857
Bradyphrenia 28.57 13.12 3 269341 9403 64219985
Stress 28.54 13.12 382 268962 60152 64169236
Maternal exposure timing unspecified 28.47 13.12 45 269299 2662 64226726
Acute pulmonary oedema 28.45 13.12 9 269335 12800 64216588
Dialysis 28.05 13.12 18 269326 16902 64212486
Spinal disorder 27.84 13.12 90 269254 8632 64220756
Chromaturia 27.80 13.12 32 269312 22579 64206809
Lymphopenia 27.74 13.12 40 269304 25617 64203771
Nightmare 27.72 13.12 28 269316 20965 64208423
Ear infection 27.67 13.12 180 269164 23224 64206164
Appendicitis 27.64 13.12 11 269333 13558 64215830
Epstein-Barr virus infection 27.34 13.12 9 269335 12479 64216909
Neck pain 27.25 13.12 384 268960 61149 64168239
Respiratory disorder 27.20 13.12 250 269094 35861 64193527
Soft tissue swelling 27.16 13.12 28 269316 1074 64228314
Weight decreased 27.01 13.12 949 268395 284790 63944598
Bunion operation 26.85 13.12 24 269320 769 64228619
Activated partial thromboplastin time prolonged 26.80 13.12 10 269334 12821 64216567
Pulse absent 26.79 13.12 3 269341 8943 64220445
Klebsiella infection 26.67 13.12 11 269333 13270 64216118
Middle lobe syndrome 26.62 13.12 9 269335 33 64229355
Tendon disorder 26.57 13.12 72 269272 6260 64223128
Rash macular 26.53 13.12 36 269308 23649 64205739
Pneumonia fungal 26.53 13.12 3 269341 8874 64220514
Diastolic dysfunction 26.52 13.12 3 269341 8872 64220516
Embolism 26.47 13.12 9 269335 12226 64217162
Sensory disturbance 26.43 13.12 11 269333 13197 64216191
Hypersomnia 26.37 13.12 26 269318 19691 64209697
Polyuria 26.16 13.12 10 269334 12633 64216755
Cholecystitis 26.14 13.12 26 269318 19610 64209778
Mean cell volume decreased 26.05 13.12 50 269294 3456 64225932
Brain injury 26.02 13.12 5 269339 9960 64219428
Lacrimation increased 25.94 13.12 23 269321 18323 64211065
Bedridden 25.92 13.12 97 269247 10012 64219376
Frequent bowel movements 25.82 13.12 23 269321 18282 64211106
Smear cervix abnormal 25.71 13.12 40 269304 2334 64227054
Tender joint count increased 25.69 13.12 12 269332 118 64229270
Infusion site pain 25.55 13.12 6 269338 10391 64218997
Bursitis 25.26 13.12 165 269179 21320 64208068
Hyperthermia 25.16 13.12 17 269327 15533 64213855
Cardiomyopathy 25.06 13.12 42 269302 25314 64204074
Heparin-induced thrombocytopenia 25.01 13.12 3 269341 8476 64220912
Hemiplegia 24.96 13.12 11 269333 12757 64216631
Myelosuppression 24.94 13.12 38 269306 23792 64205596
Ileus paralytic 24.76 13.12 3 269341 8412 64220976
Hepatic cytolysis 24.61 13.12 14 269330 14035 64215353
Hiccups 24.61 13.12 3 269341 8373 64221015
Hypercholesterolaemia 24.53 13.12 128 269216 15245 64214143
Bundle branch block left 24.24 13.12 6 269338 10028 64219360
Pulmonary arterial hypertension 24.17 13.12 43 269301 25324 64204064
Blindness 24.13 13.12 34 269310 21985 64207403
Drug specific antibody present 24.07 13.12 61 269283 5093 64224295
Enterococcal infection 24.03 13.12 14 269330 13852 64215536
Aspergillus infection 23.81 13.12 20 269324 16359 64213029
Sleep apnoea syndrome 23.81 13.12 56 269288 29776 64199612
Hyperammonaemia 23.78 13.12 6 269338 9898 64219490
Complication associated with device 23.72 13.12 17 269327 15063 64214325
Abnormal dreams 23.50 13.12 7 269337 10349 64219039
Central nervous system lesion 23.49 13.12 10 269334 11839 64217549
Adjustment disorder with depressed mood 23.34 13.12 39 269305 2418 64226970
Diabetes mellitus inadequate control 23.29 13.12 33 269311 21288 64208100
Neck surgery 23.27 13.12 30 269314 1469 64227919
Overwork 23.20 13.12 9 269335 53 64229335
Tardive dyskinesia 23.15 13.12 5 269339 9173 64220215
Pleural thickening 23.10 13.12 41 269303 2669 64226719
Inappropriate schedule of product administration 23.09 13.12 260 269084 92026 64137362
Cystitis haemorrhagic 23.01 13.12 3 269341 7953 64221435
Diabetic eye disease 22.98 13.12 12 269332 153 64229235
Viral upper respiratory tract infection 22.90 13.12 81 269263 8134 64221254
Purpura 22.77 13.12 23 269321 17223 64212165
Asphyxia 22.58 13.12 6 269338 9560 64219828
Back disorder 22.48 13.12 92 269252 9898 64219490
Hepatocellular carcinoma 22.41 13.12 4 269340 8399 64220989
Osteomyelitis 22.32 13.12 194 269150 27393 64201995
Bronchospasm 22.28 13.12 35 269309 21647 64207741
Muscle relaxant therapy 22.25 13.12 12 269332 164 64229224
Cerebral ischaemia 22.13 13.12 7 269337 9955 64219433
Limb operation 21.99 13.12 41 269303 2773 64226615
Eye swelling 21.93 13.12 37 269307 22244 64207144
Intervertebral disc compression 21.93 13.12 24 269320 987 64228401
Pulseless electrical activity 21.88 13.12 13 269331 12726 64216662
Premature labour 21.74 13.12 3 269341 7617 64221771
Paraesthesia oral 21.72 13.12 14 269330 13117 64216271
Spinal meningioma benign 21.62 13.12 10 269334 96 64229292
Inflammatory pain 21.55 13.12 22 269322 834 64228554
Anal incontinence 21.55 13.12 19 269325 15177 64214211
Escherichia infection 21.47 13.12 19 269325 15149 64214239
Hepatitis cholestatic 21.46 13.12 12 269332 12143 64217245
Alanine aminotransferase increased 21.40 13.12 745 268599 138286 64091102
Eructation 21.25 13.12 6 269338 9185 64220203
Pharyngeal oedema 21.23 13.12 124 269220 15407 64213981
Enteritis 21.21 13.12 12 269332 12065 64217323
Petechiae 21.18 13.12 28 269316 18598 64210790
Bacterial sepsis 21.12 13.12 3 269341 7454 64221934
Pleural fibrosis 21.11 13.12 50 269294 4000 64225388
Arthritis infective 21.06 13.12 71 269273 6959 64222429
Feeling abnormal 21.04 13.12 412 268932 133190 64096198
Aspartate aminotransferase increased 21.04 13.12 652 268692 119136 64110252
Personality change 21.03 13.12 5 269339 8588 64220800
Eye disorder 21.03 13.12 143 269201 18726 64210662
Enterocolitis 21.02 13.12 12 269332 12006 64217382
Musculoskeletal discomfort 20.99 13.12 128 269216 16149 64213239
Immobile 20.98 13.12 64 269280 5951 64223437
Hyperlipidaemia 20.96 13.12 40 269304 22936 64206452
Flank pain 20.91 13.12 22 269322 16167 64213221
Posterior reversible encephalopathy syndrome 20.88 13.12 40 269304 22906 64206482
Thirst 20.88 13.12 17 269327 14120 64215268
Haemolysis 20.82 13.12 10 269334 11029 64218359
Peritonitis bacterial 20.73 13.12 6 269338 9037 64220351
Presbyacusis 20.73 13.12 38 269306 2537 64226851
Cardiac failure chronic 20.72 13.12 6 269338 9035 64220353
Carotid artery stenosis 20.70 13.12 4 269340 7937 64221451
Retching 20.54 13.12 20 269324 15236 64214152
Throat tightness 20.54 13.12 41 269303 23119 64206269
Knee deformity 20.47 13.12 22 269322 886 64228502
Osteonecrosis of jaw 20.45 13.12 91 269253 39734 64189654
Glycosylated haemoglobin increased 20.43 13.12 22 269322 15997 64213391
Juvenile idiopathic arthritis 20.34 13.12 48 269296 3831 64225557
Enthesophyte 20.03 13.12 6 269338 13 64229375
Hepatic ischaemia 20.01 13.12 23 269321 999 64228389
Ocular hyperaemia 19.96 13.12 40 269304 22524 64206864
Dry eye 19.92 13.12 197 269147 28822 64200566
Exercise tolerance decreased 19.86 13.12 4 269340 7706 64221682
Hyperuricaemia 19.58 13.12 9 269335 10182 64219206
Brain natriuretic peptide increased 19.57 13.12 4 269340 7629 64221759
Increased appetite 19.43 13.12 9 269335 10137 64219251
Oral discomfort 19.38 13.12 78 269266 8328 64221060
Burning sensation 19.12 13.12 125 269219 49539 64179849
Azotaemia 19.10 13.12 4 269340 7498 64221890
Nystagmus 19.05 13.12 7 269337 9061 64220327
Stress at work 18.93 13.12 22 269322 967 64228421
Steatohepatitis 18.91 13.12 20 269324 791 64228597
Hepatic cancer 18.90 13.12 4 269340 7444 64221944
Glomerular filtration rate decreased 18.81 13.12 33 269311 19539 64209849
Dysphonia 18.75 13.12 115 269229 46267 64183121
Ageusia 18.72 13.12 18 269326 13795 64215593
Caesarean section 18.68 13.12 12 269332 11262 64218126
Drug level below therapeutic 18.67 13.12 4 269340 7380 64222008
Pyopneumothorax 18.66 13.12 8 269336 63 64229325
Accident 18.65 13.12 67 269277 6779 64222609
Tenderness 18.64 13.12 143 269201 19459 64209929
Cholangitis 18.59 13.12 11 269333 10791 64218597
Hepatomegaly 18.57 13.12 26 269318 16856 64212532
Wheelchair user 18.49 13.12 52 269292 4620 64224768
Unevaluable event 18.48 13.12 129 269215 50360 64179028
Hypertriglyceridaemia 18.46 13.12 12 269332 11193 64218195
Feeling cold 18.46 13.12 45 269299 23633 64205755
Blood culture positive 18.44 13.12 5 269339 7863 64221525
Oral disorder 18.40 13.12 80 269264 8841 64220547
Haemolytic anaemia 18.39 13.12 24 269320 16029 64213359
Hypovolaemic shock 18.32 13.12 10 269334 10256 64219132
Cerebral atrophy 18.31 13.12 4 269340 7281 64222107
Refusal of treatment by patient 18.27 13.12 6 269338 8333 64221055
Major depression 18.26 13.12 5 269339 7811 64221577
Joint noise 18.23 13.12 41 269303 3170 64226218
Blood albumin decreased 18.09 13.12 38 269306 21035 64208353
Device leakage 18.02 13.12 6 269338 8260 64221128
Urticarial vasculitis 18.01 13.12 15 269329 436 64228952
Prostatic specific antigen increased 18.01 13.12 7 269337 8753 64220635
Nail psoriasis 18.00 13.12 14 269330 368 64229020
Hypertransaminasaemia 17.97 13.12 4 269340 7187 64222201
Cerebral haematoma 17.95 13.12 4 269340 7181 64222207
Eyelid oedema 17.84 13.12 15 269329 12264 64217124
Metabolic disorder 17.84 13.12 5 269339 7692 64221696
Hypercapnia 17.83 13.12 5 269339 7689 64221699
Blood pressure fluctuation 17.75 13.12 310 269034 51561 64177827
Benign prostatic hyperplasia 17.75 13.12 8 269336 9157 64220231
Proteinuria 17.69 13.12 58 269286 27665 64201723
Amenorrhoea 17.68 13.12 3 269341 6536 64222852
Live birth 17.68 13.12 93 269251 11111 64218277
Malignant neoplasm of conjunctiva 17.53 13.12 7 269337 45 64229343
Bronchiectasis 17.49 13.12 110 269234 14030 64215358
Decubitus ulcer 17.49 13.12 18 269326 13361 64216027
Cold sweat 17.45 13.12 26 269318 16429 64212959
Feeding disorder 17.45 13.12 103 269241 12846 64216542
Mean cell haemoglobin decreased 17.43 13.12 47 269297 4075 64225313
Mycobacterium marinum infection 17.34 13.12 14 269330 389 64228999
Pseudomonas infection 17.32 13.12 30 269314 17853 64211535
Nephropathy toxic 17.32 13.12 29 269315 17485 64211903
Progressive multifocal leukoencephalopathy 17.29 13.12 31 269313 18201 64211187
Abscess 17.27 13.12 34 269310 19270 64210118
Diffuse large B-cell lymphoma 17.21 13.12 11 269333 10350 64219038
Ammonia increased 17.19 13.12 4 269340 6973 64222415
Interstitial lung disease 17.17 13.12 532 268812 97200 64132188
Congestive cardiomyopathy 17.15 13.12 11 269333 10333 64219055
Muscle spasms 17.09 13.12 453 268891 140570 64088818
Hepatic necrosis 17.04 13.12 7 269337 8466 64220922
Cartilage atrophy 17 13.12 10 269334 163 64229225
Therapeutic response unexpected 16.95 13.12 28 269316 16973 64212415
Dermatitis acneiform 16.94 13.12 7 269337 8436 64220952
Hypertonia 16.89 13.12 3 269341 6322 64223066
Left ventricular failure 16.86 13.12 7 269337 8410 64220978
Abdominal pain upper 16.82 13.12 893 268451 174137 64055251
Neurological symptom 16.79 13.12 4 269340 6860 64222528
Coronary artery occlusion 16.71 13.12 20 269324 13871 64215517
Sinus node dysfunction 16.66 13.12 4 269340 6824 64222564
Neoplasm malignant 16.65 13.12 167 269177 24521 64204867
Blood pressure systolic decreased 16.62 13.12 8 269336 8812 64220576
Potentiating drug interaction 16.60 13.12 6 269338 7846 64221542
Hepatitis C 16.57 13.12 13 269331 11002 64218386
Large intestine perforation 16.42 13.12 17 269327 12587 64216801
Peripheral sensory neuropathy 16.41 13.12 14 269330 11364 64218024
Thyroid disorder 16.40 13.12 94 269250 11598 64217790
Extra dose administered 16.38 13.12 4 269340 6746 64222642
Nervous system disorder 16.36 13.12 46 269298 23032 64206356
Post procedural complication 16.32 13.12 41 269303 21312 64208076
Myositis 16.30 13.12 27 269317 16350 64213038
Renal disorder 16.29 13.12 84 269260 35281 64194107
Pulmonary cavitation 16.20 13.12 24 269320 1341 64228047
Orthopnoea 16.15 13.12 9 269335 9125 64220263
Blood potassium increased 16.13 13.12 55 269289 25925 64203463
Vaginal haematoma 16.07 13.12 9 269335 133 64229255
Oral surgery 16.07 13.12 20 269324 945 64228443
CD4/CD8 ratio increased 16.06 13.12 5 269339 13 64229375
Extrasystoles 16.05 13.12 4 269340 6654 64222734
Lipase increased 16.02 13.12 22 269322 14380 64215008
Cardiac tamponade 16.01 13.12 7 269337 8157 64221231
Cataract 16.01 13.12 302 269042 50960 64178428
Ossicle disorder 15.95 13.12 6 269338 32 64229356
Elbow deformity 15.95 13.12 23 269321 1254 64228134
Blood magnesium increased 15.89 13.12 39 269305 3192 64226196
Walking aid user 15.88 13.12 60 269284 6221 64223167
Pyelonephritis 15.80 13.12 30 269314 17236 64212152
Abortion spontaneous 15.77 13.12 53 269291 25090 64204298
Productive cough 15.75 13.12 213 269131 72990 64156398
Thinking abnormal 15.73 13.12 15 269329 11541 64217847
Acute hepatic failure 15.73 13.12 56 269288 26056 64203332
Renal tubular disorder 15.64 13.12 3 269341 5984 64223404
Muscle tightness 15.64 13.12 14 269330 11101 64218287
Brain herniation 15.60 13.12 4 269340 6529 64222859
Gastric haemorrhage 15.60 13.12 20 269324 13461 64215927
Ventricular hypertrophy 15.54 13.12 4 269340 6512 64222876
Hiatus hernia 15.50 13.12 38 269306 19919 64209469
Serum ferritin increased 15.47 13.12 8 269336 8460 64220928
Aplasia pure red cell 15.45 13.12 5 269339 7009 64222379
Restless legs syndrome 15.43 13.12 30 269314 17086 64212302
Rash papular 15.43 13.12 30 269314 17083 64212305
Amyotrophic lateral sclerosis 15.42 13.12 26 269318 1624 64227764
Hepatitis acute 15.35 13.12 20 269324 13369 64216019
Pulmonary function test decreased 15.35 13.12 4 269340 6457 64222931
Aortic arteriosclerosis 15.33 13.12 6 269338 7470 64221918
Tooth infection 15.30 13.12 109 269235 14492 64214896
Therapy change 15.25 13.12 4 269340 6430 64222958
Thrombotic microangiopathy 15.19 13.12 29 269315 16626 64212762
Ventricular arrhythmia 15.12 13.12 6 269338 7409 64221979
Swelling face 15.07 13.12 166 269178 59000 64170388
Epistaxis 15.03 13.12 304 269040 97827 64131561
Lacrimal disorder 14.95 13.12 14 269330 477 64228911
Forced expiratory volume decreased 14.94 13.12 5 269339 6862 64222526
Gout 14.94 13.12 43 269301 21370 64208018
Aortic valve incompetence 14.94 13.12 8 269336 8293 64221095
Clear cell renal cell carcinoma 14.89 13.12 30 269314 2149 64227239
Rotator cuff syndrome 14.86 13.12 94 269250 12013 64217375
Glaucoma 14.85 13.12 118 269226 16230 64213158
Diffuse idiopathic skeletal hyperostosis 14.84 13.12 6 269338 40 64229348
Hepatotoxicity 14.83 13.12 242 269102 39720 64189668
Facial paralysis 14.82 13.12 36 269308 18930 64210458
Colitis ulcerative 14.82 13.12 48 269296 22980 64206408
Intervertebral disc protrusion 14.81 13.12 139 269205 20052 64209336
Urine analysis abnormal 14.80 13.12 3 269341 5753 64223635
Cardiac granuloma 14.71 13.12 4 269340 5 64229383
Paralysis 14.71 13.12 16 269328 11579 64217809
Jaundice cholestatic 14.68 13.12 9 269335 8661 64220727
Lung consolidation 14.67 13.12 7 269337 7751 64221637
Aortic bruit 14.67 13.12 10 269334 213 64229175
Pulmonary granuloma 14.63 13.12 27 269317 1812 64227576
Erythema multiforme 14.61 13.12 27 269317 15674 64213714
Spinal cord compression 14.60 13.12 3 269341 5700 64223688
Immunosuppressant drug level increased 14.60 13.12 6 269338 7253 64222135
Tender joint count 14.59 13.12 6 269338 42 64229346
Intestinal ischaemia 14.58 13.12 16 269328 11533 64217855
Metastasis 14.57 13.12 3 269341 5692 64223696
Joint ankylosis 14.54 13.12 17 269327 752 64228636
Portal hypertension 14.49 13.12 4 269340 6215 64223173
Ear infection bacterial 14.48 13.12 6 269338 43 64229345
Respiratory tract infection 14.47 13.12 94 269250 37313 64192075
Anaplastic thyroid cancer 14.45 13.12 5 269339 20 64229368
Transplant rejection 14.43 13.12 32 269312 17369 64212019
Embolic stroke 14.41 13.12 5 269339 6706 64222682
Prostate cancer 14.37 13.12 39 269305 19756 64209632
Cell-mediated cytotoxicity 14.36 13.12 6 269338 44 64229344
Vascular device infection 14.35 13.12 4 269340 6176 64223212
Dermatitis contact 14.35 13.12 10 269334 8990 64220398
C-reactive protein decreased 14.30 13.12 29 269315 2087 64227301
Feeling hot 14.21 13.12 122 269222 45541 64183847
Swollen joint count 14.18 13.12 15 269329 593 64228795
Device malfunction 14.15 13.12 33 269311 17600 64211788
Hydrocephalus 14.13 13.12 7 269337 7584 64221804
Sensory loss 14.08 13.12 13 269331 10156 64219232
Pulmonary alveolar haemorrhage 14.02 13.12 12 269332 9726 64219662
Hypothyroidism 14.01 13.12 105 269239 40352 64189036
Pain in jaw 14.01 13.12 106 269238 40649 64188739
Rheumatoid factor 14.01 13.12 8 269336 123 64229265
Eye movement disorder 13.99 13.12 6 269338 7073 64222315
Multiple sclerosis 13.99 13.12 37 269307 18904 64210484
Thrombosis 13.98 13.12 209 269135 70433 64158955
Metabolic surgery 13.97 13.12 18 269326 881 64228507
Loss of employment 13.93 13.12 27 269317 1880 64227508
Inflammatory marker increased 13.93 13.12 71 269273 8380 64221008
Peripheral coldness 13.89 13.12 22 269322 13562 64215826
Blood cholesterol abnormal 13.87 13.12 33 269311 2648 64226740
Amylase increased 13.87 13.12 12 269332 9673 64219715
Lung infiltration 13.82 13.12 43 269301 20846 64208542
Weber tuning fork test abnormal 13.77 13.12 7 269337 84 64229304
Respiratory tract congestion 13.77 13.12 115 269229 16050 64213338
Splenic embolism 13.74 13.12 9 269335 179 64229209
Nervousness 13.73 13.12 70 269274 29486 64199902
Large intestine polyp 13.69 13.12 15 269329 10822 64218566
Tongue oedema 13.68 13.12 4 269340 5986 64223402
Scoliosis 13.68 13.12 56 269288 6026 64223362
Larsen syndrome 13.57 13.12 4 269340 8 64229380
Rib fracture 13.54 13.12 53 269291 23985 64205403
Pregnancy 13.53 13.12 140 269204 20725 64208663
Retinal haemorrhage 13.50 13.12 7 269337 7391 64221997
Concomitant disease aggravated 13.49 13.12 17 269327 11525 64217863
Crystal arthropathy 13.48 13.12 9 269335 185 64229203
Red blood cell count decreased 13.45 13.12 133 269211 48253 64181135
Dermatitis exfoliative generalised 13.42 13.12 4 269340 5912 64223476
Eyelid ptosis 13.40 13.12 12 269332 9513 64219875
Photosensitivity reaction 13.27 13.12 125 269219 18048 64211340
Vitreous floaters 13.25 13.12 5 269339 6368 64223020
Hyperventilation 13.20 13.12 6 269338 6834 64222554
Hepatic steatosis 13.13 13.12 192 269152 30815 64198573
Polyneuropathy 13.13 13.12 41 269303 19853 64209535

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA13 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D004791 Enzyme Inhibitors
CHEBI has role CHEBI:35442 antiparasitic drugs
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35705 immunosuppressive agents
CHEBI has role CHEBI:37153 protein serine/threonine phosphatase inhibitors
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:68542 DHODH inhibitor
CHEBI has role CHEBI:68543 pyrimidine synthesis inhibitors
FDA EPC N0000175713 Antirheumatic Agent
FDA MoA N0000185501 Dihydroorotate Dehydrogenase Inhibitors
FDA EPC N0000185502 Pyrimidine Synthesis Inhibitor
CHEBI has role CHEBI:49103 drug metabolites

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

DiseaseRelationSNOMED_IDDOID
Psoriasis with arthropathy indication 33339001
Rheumatoid arthritis indication 69896004 DOID:7148
Inactive tuberculosis contraindication 11999007
Agranulocytosis contraindication 17182001 DOID:12987
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hepatic failure contraindication 59927004
Chronic type B viral hepatitis contraindication 61977001
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Aspergillosis contraindication 65553006 DOID:13564
Viral hepatitis type B contraindication 66071002 DOID:2043
Kidney disease contraindication 90708001 DOID:557
Pancytopenia contraindication 127034005 DOID:12450
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Acute hepatitis C contraindication 235866006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339
Severe Bone Marrow Depression contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.31 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme INHIBITOR IC50 5 CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.64 DRUG MATRIX
Cytochrome P450 1A2 Enzyme IC50 6.30 DRUG MATRIX
Amine oxidase [flavin-containing] A Enzyme IC50 4.68 DRUG MATRIX
Sodium/nucleoside cotransporter 1 Transporter Ki 5.29 DRUG MATRIX
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 8.05 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 7.52 CHEMBL

External reference:

IDSource
4021132 VUID
N0000148586 NUI
D00749 KEGG_DRUG
4021132 VANDF
4031717 VANDF
C0063041 UMLSCUI
CHEBI:6402 CHEBI
CHEBI:68540 CHEBI
CHEMBL960 ChEMBL_ID
DB01097 DRUGBANK_ID
D000077339 MESH_DESCRIPTOR_UI
3899 PUBCHEM_CID
6825 IUPHAR_LIGAND_ID
C527525 MESH_SUPPLEMENTAL_RECORD_UI
5079 INN_ID
G162GK9U4W UNII
DB08880 DRUGBANK_ID
1310520 RXNORM
11870 MMSL
28846 MMSL
63949 MMSL
7491 MMSL
d04349 MMSL
d07905 MMSL
007642 NDDF
014643 NDDF
109143003 SNOMEDCT_US
386981009 SNOMEDCT_US
703785006 SNOMEDCT_US
703786007 SNOMEDCT_US
54684141 PUBCHEM_CID
C1718383 UMLSCUI
7761 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2160 TABLET, FILM COATED 10 mg ORAL NDA 27 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2161 TABLET, FILM COATED 20 mg ORAL NDA 27 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2162 TABLET, FILM COATED 100 mg ORAL NDA 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1735 TABLET, FILM COATED 10 mg ORAL NDA AUTHORIZED GENERIC 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1735 TABLET, FILM COATED 10 mg ORAL NDA AUTHORIZED GENERIC 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1737 TABLET, FILM COATED 20 mg ORAL NDA AUTHORIZED GENERIC 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1737 TABLET, FILM COATED 20 mg ORAL NDA AUTHORIZED GENERIC 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-277 TABLET 10 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-278 TABLET 20 mg Oral ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-043 TABLET 10 mg ORAL ANDA 23 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-043 TABLET 10 mg ORAL ANDA 23 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-044 TABLET 20 mg ORAL ANDA 23 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-044 TABLET 20 mg ORAL ANDA 23 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 35573-447 TABLET, FILM COATED 10 mg ORAL ANDA 27 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 35573-448 TABLET, FILM COATED 20 mg ORAL ANDA 27 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-420 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-421 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide Human Prescription Drug Label 1 46708-436 TABLET 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 46708-437 TABLET 20 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 50090-5992 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 50268-477 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 50268-478 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-2319 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-6170 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 59651-348 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 59651-349 TABLET, FILM COATED 20 mg ORAL ANDA 26 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2502 TABLET 10 mg ORAL ANDA 18 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2503 TABLET 20 mg ORAL ANDA 18 sections
Leflunomide Human Prescription Drug Label 1 62332-061 TABLET 10 mg ORAL ANDA 26 sections
Leflunomide Human Prescription Drug Label 1 62332-062 TABLET 20 mg ORAL ANDA 26 sections