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

Stem definitionDrug idCAS RN
Janus kinase inhibitors, antineoplastics 4713 477600-75-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tasocitinib
  • xeljanz
  • CP 690550
  • tofacitinib citrate
  • tofacitinib
  • CP-690550
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
  • Molecular weight: 312.38
  • Formula: C16H20N6O
  • CLOGP: 2.03
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 88.91
  • ALOGS: -3.02
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 1.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.88 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.60 % Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.185 Moderate 0.75
caco2-efflux Caco-2 efflux ratio (BA/AB) 2.864 Moderate 0.75
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 31.261 10^-6 cm/s Moderate 0.75
dh-clint Dog hepatocyte intrinsic clearance 1.687 uL/min/10^6 cells Moderate 0.75
dppb Dog plasma protein binding (% unbound) 67.170 % Moderate 0.75
fcs-ppb Fetal calf serum protein binding (% unbound) 83.080 % Moderate 0.75
herg hERG pIC50 4.335 pIC50 Moderate 0.75
hh-clint Human hepatocyte intrinsic clearance 1.321 uL/min/10^6 cells Moderate 0.75
hlm-clint Human liver microsomal intrinsic clearance 6.053 uL/min/mg protein Moderate 0.75
hppb Human plasma protein binding (% unbound) 52.880 % Moderate 0.75
kinase-safety-class AAK1,ACVR2A,ACVR2B,ALK,AURKA,AURKB,AURKC,AXL,BLK,BRAF,CAMK2B,CAMK2D,CDK1,CDK14,CDK16,CDK9,CHEK1,CLK2,CLK4,CSF1R,DDR1,DYRK1B,EGFR,EIF2AK3,ERBB2,FGFR1,FLT3,GRK1,GRK2,GRK3,GSK3B,IGF1R,IKBKB,IRAK1,ITK,JAK1,JAK2,JAK3,KIT,LCK,MAP2K6,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP4K1,MAP4K2,MAP4K3,MAP4K5,MAPK1,MAPK10,MAPK3,MAPK7,MAPK9,MARK4,MELK,MET,NTRK1,PAK4,PDK1,PDK2,PDK4,PIK3CD,PRKAA1,PRKAA2,PRKACA,PRKCD,PRKDC,PRKG1,ROCK1,ROCK2,RPS6KA1,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ULK2 81
kinase-selectivity-class AAK1,ACVR2B,AURKA,AURKB,AXL,BMX,BRAF,CAMK2D,CDK9,CLK2,CLK4,DYRK1B,EGFR,FLT3,GSK3B,HASPIN,IRAK1,JAK1,JAK2,JAK3,KDR,MAP3K10,MAP3K21,MAP4K1,MAP4K3,MAPK1,MARK4,NTRK1,PDK1,PRKCD,SGK1,SIK2,SIK3,STK17A,STK33,SYK,ULK1 37
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 4.457 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 5.309 Moderate 0.75
mh-clint Mouse hepatocyte intrinsic clearance 20.370 Moderate 0.75
mppb Mouse plasma protein binding (% unbound) 62.670 Moderate 0.75
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 20.701 Moderate 0.75
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 78.950 % Moderate 0.75
rat-kpuu-brain Rat brain Kpuu 0.032 % High 1
rh-clint Rat hepatocyte intrinsic clearance 7.780 uL/min/10^6 cells Moderate 0.75
rh-fuinc Rat hepatocyte fraction unbound in incubation 89 % Moderate 0.75
rppb Rat plasma protein binding (% unbound) 59.440 % Moderate 0.75
solubility-dd Solubility at pH 7.4 in DMSO 959.401 uM Moderate 0.75

Approvals:

DateAgencyCompanyOrphan
March 25, 2013 PMDA Pfizer Japan Inc.
Nov. 6, 2012 FDA PF PRISM CV
March 22, 2017 EMA PFIZER EUROPE MA EEIG

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 6193.15 15.11 23363 651355 1360935 88592794
Condition aggravated 3320.80 15.11 10846 663872 584699 89369030
Joint swelling 2942.65 15.11 9320 665398 493980 89459749
Synovitis 2583.63 15.11 6787 667931 322965 89630764
Arthralgia 2529.04 15.11 11961 662757 766561 89187168
Product dose omission in error 2346.64 15.11 1614 673104 18889 89934840
Drug intolerance 2228.18 15.11 7855 666863 439736 89513993
Musculoskeletal stiffness 2175.27 15.11 5958 668760 290574 89663155
Pain 2050.35 15.11 13534 661184 982807 88970922
Treatment failure 1989.61 15.11 5861 668857 298067 89655662
Therapeutic product effect incomplete 1934.89 15.11 4383 670335 189513 89764216
Therapeutic product effect decreased 1842.46 15.11 5380 669338 272191 89681538
Contraindicated product administered 1735.03 15.11 5783 668935 314356 89639373
Acute kidney injury 1670.90 15.11 209 674509 320178 89633551
Arthropathy 1619.74 15.11 6189 668529 360053 89593676
Toxicity to various agents 1537.48 15.11 173 674545 287673 89666056
Discouragement 1493.13 15.11 533 674185 1104 89952625
Hypotension 1490.91 15.11 304 674414 325093 89628636
Hand deformity 1441.85 15.11 5166 669552 291196 89662533
Swelling 1390.64 15.11 6488 668230 412570 89541159
Abdominal discomfort 1221.81 15.11 6872 667846 470456 89483273
Blood cholesterol increased 1177.85 15.11 3816 670902 204196 89749533
Sensitivity to weather change 1145.12 15.11 754 673964 8160 89945569
Hepatic enzyme increased 1137.71 15.11 5505 669213 355231 89598498
Drug interaction 1099.16 15.11 345 674373 276108 89677621
Anaemia 1080.20 15.11 644 674074 352158 89601571
Febrile neutropenia 1078.35 15.11 20 674698 158329 89795400
Completed suicide 1060.14 15.11 3 674715 145055 89808674
Glossodynia 1052.44 15.11 4963 669755 316816 89636913
Anti-cyclic citrullinated peptide antibody positive 1044.09 15.11 3996 670722 232437 89721292
Wound 1034.95 15.11 4733 669985 298247 89655482
Neutropenia 1019.66 15.11 215 674503 224689 89729040
Pemphigus 1006.61 15.11 4955 669763 321909 89631820
Systemic lupus erythematosus 980.44 15.11 5293 669425 356603 89597126
Death 965.78 15.11 1188 673530 455363 89498366
Peripheral swelling 952.83 15.11 5788 668930 407318 89546411
Alopecia 937.81 15.11 6601 668117 488470 89465259
Pericarditis 887.52 15.11 4173 670545 265978 89687751
Dehydration 845.03 15.11 204 674514 194243 89759486
Rheumatoid factor positive 839.41 15.11 2999 671719 168651 89785078
Infection 805.99 15.11 5028 669690 357066 89596663
Discomfort 801.99 15.11 4099 670619 270236 89683493
Injection site pain 779.17 15.11 170 674548 173529 89780200
Loss of personal independence in daily activities 748.36 15.11 2473 672245 133632 89820097
Hyponatraemia 747.10 15.11 67 674651 133471 89820258
Malignant neoplasm progression 738.00 15.11 11 674707 106859 89846870
Helicobacter infection 733.01 15.11 3488 671230 223362 89730367
Seizure 714.46 15.11 135 674583 152494 89801235
Illness 703.79 15.11 1749 672969 80220 89873509
Pain in extremity 696.34 15.11 5729 668989 444800 89508929
Duodenal ulcer perforation 665.13 15.11 3333 671385 217955 89735774
Product dose omission issue 648.42 15.11 4050 670668 287637 89666092
Pancytopenia 647.44 15.11 70 674648 120193 89833536
Somnolence 644.63 15.11 378 674340 208706 89745023
Rheumatoid arthritis 642.92 15.11 4761 669957 357853 89595876
Herpes zoster 633.66 15.11 1842 672876 92802 89860927
Dyspnoea 629.35 15.11 3914 670804 877041 89076688
Cardiac arrest 611.06 15.11 44 674674 104891 89848838
Nasopharyngitis 600.17 15.11 5123 669595 401981 89551748
COVID-19 590.12 15.11 2657 672061 166186 89787543
Drug abuse 589.21 15.11 4 674714 82343 89871386
Hypersensitivity 585.64 15.11 5556 669162 449121 89504608
Disease progression 576.42 15.11 222 674496 156393 89797336
C-reactive protein abnormal 572.77 15.11 2167 672551 125262 89828467
Inflammation 530.88 15.11 2682 672036 175910 89777819
Tremor 523.82 15.11 242 674476 152931 89800798
Intentional overdose 519.69 15.11 49 674669 93785 89859944
Oxygen saturation decreased 516.11 15.11 89 674629 107394 89846335
Joint stiffness 515.76 15.11 1512 673206 76530 89877199
Thrombocytopenia 515.63 15.11 476 674242 208249 89745480
Respiratory failure 510.90 15.11 126 674592 118292 89835437
Sepsis 505.29 15.11 361 674357 179453 89774276
Bradycardia 500.41 15.11 31 674687 83816 89869913
Depressed level of consciousness 492.15 15.11 10 674708 72774 89880955
Infusion related reaction 485.83 15.11 4989 669729 411791 89541938
Platelet count decreased 484.73 15.11 206 674512 136763 89816966
Impaired healing 480.94 15.11 3188 671530 231011 89722718
Chest discomfort 470.96 15.11 220 674498 138145 89815584
Renal failure 468.49 15.11 194 674524 130813 89822916
Joint range of motion decreased 465.22 15.11 2123 672595 133520 89820209
Product use issue 457.90 15.11 4098 670620 325821 89627908
Vomiting 457.10 15.11 3718 671000 784575 89169154
Cardio-respiratory arrest 452.07 15.11 3 674715 63137 89890592
Mobility decreased 448.99 15.11 3301 671417 247433 89706296
Haemoglobin decreased 446.12 15.11 332 674386 161624 89792105
Hypokalaemia 443.91 15.11 210 674508 130906 89822823
Irritable bowel syndrome 435.05 15.11 2839 671879 204609 89749120
Coma 433.01 15.11 27 674691 72605 89881124
Rheumatic fever 430.31 15.11 2264 672454 150857 89802872
Hyperkalaemia 427.46 15.11 12 674706 64952 89888777
Hypoxia 422.54 15.11 30 674688 72369 89881360
Folliculitis 422.07 15.11 2786 671932 201567 89752162
Muscle injury 420.74 15.11 2498 672220 174156 89779573
Red blood cell sedimentation rate increased 415.33 15.11 1457 673261 81138 89872591
Hypoglycaemia 410.38 15.11 28 674690 69820 89883909
Gastrointestinal haemorrhage 409.35 15.11 86 674632 90162 89863567
Drug hypersensitivity 407.12 15.11 5253 669465 458356 89495373
Therapeutic response unexpected 407.06 15.11 646 674072 21234 89932495
Constipation 404.94 15.11 932 673786 279463 89674266
Syncope 401.52 15.11 245 674473 132418 89821311
Tachycardia 398.40 15.11 352 674366 157321 89796408
Neutrophil count decreased 397.06 15.11 37 674681 71495 89882234
Suicide attempt 390.62 15.11 50 674668 75349 89878380
Cardiac failure 382.15 15.11 168 674550 109328 89844401
Atrial fibrillation 380.92 15.11 264 674454 133347 89820382
Hallucination 377.35 15.11 30 674688 65929 89887800
Sinusitis 376.51 15.11 4058 670660 339030 89614699
Sleep disorder due to general medical condition, insomnia type 369.95 15.11 1915 672803 126779 89826950
Fibromyalgia 368.22 15.11 2714 672004 203555 89750174
Neuropathy peripheral 362.96 15.11 292 674426 136678 89817051
Asthenia 361.36 15.11 2408 672310 531343 89422386
Agitation 361.24 15.11 39 674679 67059 89886670
Swollen joint count increased 360.28 15.11 1712 673006 109494 89844235
Overdose 356.96 15.11 388 674330 157321 89796408
Multiple organ dysfunction syndrome 352.36 15.11 46 674672 68290 89885439
Rash 351.48 15.11 8071 666647 788029 89165700
Multiple sclerosis relapse 350.43 15.11 8 674710 52297 89901432
Red blood cell sedimentation rate abnormal 347.71 15.11 637 674081 23567 89930162
Injection site erythema 345.54 15.11 150 674568 98352 89855377
Lactic acidosis 344.97 15.11 6 674712 50457 89903272
Sedation 341.37 15.11 3 674715 48168 89905561
Cognitive disorder 340.93 15.11 54 674664 69353 89884376
Flushing 339.82 15.11 117 674601 88374 89865355
Weight decreased 338.37 15.11 1565 673153 378345 89575384
Blood pressure decreased 336.34 15.11 73 674645 74822 89878907
Therapy interrupted 334.07 15.11 974 673744 49134 89904595
Incorrect dose administered 332.72 15.11 88 674630 78842 89874887
Pleural effusion 327.65 15.11 215 674503 111776 89841953
Suicidal ideation 325.60 15.11 75 674643 73780 89879949
Angioedema 324.31 15.11 48 674670 64828 89888901
International normalised ratio increased 321.92 15.11 6 674712 47310 89906419
Tuberculin test positive 316.54 15.11 245 674473 3480 89950249
Blister 314.27 15.11 3089 671629 251909 89701820
Fall 313.44 15.11 2199 672519 479611 89474118
Rhabdomyolysis 311.80 15.11 17 674701 51239 89902490
Type 2 diabetes mellitus 311.76 15.11 2582 672136 200662 89753067
Knee arthroplasty 310.88 15.11 1336 673382 81846 89871883
Gastrointestinal disorder 309.33 15.11 3095 671623 253592 89700137
Encephalopathy 307.72 15.11 8 674710 46436 89907293
Vision blurred 302.52 15.11 227 674491 110066 89843663
Dysphagia 300.44 15.11 237 674481 112041 89841688
Dysarthria 300.21 15.11 29 674689 54453 89899276
Ascites 299.50 15.11 13 674705 47727 89906002
Arthritis 299.41 15.11 2203 672515 165112 89788617
Osteoarthritis 296.71 15.11 2480 672238 193250 89760479
Rheumatoid nodule 296.36 15.11 536 674182 19630 89934099
Balance disorder 295.54 15.11 178 674540 96902 89856827
Nausea 295.50 15.11 6168 668550 1104148 88849581
Ill-defined disorder 293.88 15.11 2368 672350 182523 89771206
Hyperglycaemia 292.09 15.11 23 674695 50947 89902782
Accidental exposure to product 289.76 15.11 5 674713 42361 89911368
Cardiac failure congestive 289.36 15.11 189 674529 98505 89855224
Wrong technique in product usage process 288.31 15.11 87 674631 71484 89882245
Inappropriate schedule of product administration 288.02 15.11 418 674300 149515 89804214
White blood cell count decreased 279.71 15.11 510 674208 166599 89787130
Intentional dose omission 278.50 15.11 486 674232 17297 89936432
Musculoskeletal pain 269.81 15.11 2189 672529 169062 89784667
Neoplasm progression 266.79 15.11 16 674702 44470 89909259
Myelosuppression 264.79 15.11 41 674677 53550 89900179
Palpitations 262.81 15.11 381 674337 136347 89817382
Osteonecrosis of jaw 261.89 15.11 6 674712 39097 89914632
Heart rate increased 259.65 15.11 274 674444 112628 89841101
Metabolic acidosis 256.74 15.11 51 674667 55625 89898104
Drug reaction with eosinophilia and systemic symptoms 254.55 15.11 16 674702 42742 89910987
Blood bilirubin increased 253.69 15.11 18 674700 43452 89910277
Injection site swelling 253.57 15.11 66 674652 59773 89893956
Mental status changes 250.95 15.11 22 674696 44657 89909072
Cholestasis 249.44 15.11 4 674714 36295 89917434
Unresponsive to stimuli 247.31 15.11 8 674710 38113 89915616
Pulmonary oedema 247.29 15.11 77 674641 62003 89891726
Mucosal inflammation 247.18 15.11 62 674656 57563 89896166
Plasma cell myeloma 246.93 15.11 14 674704 40814 89912915
Lethargy 246.74 15.11 81 674637 63058 89890671
Hypomagnesaemia 244.23 15.11 4 674714 35584 89918145
Dyspnoea exertional 241.24 15.11 118 674600 72170 89881559
Abortion spontaneous 240.07 15.11 54 674664 54002 89899727
Agranulocytosis 239.93 15.11 4 674714 34998 89918731
Acute respiratory failure 238.72 15.11 22 674696 42896 89910833
Stomatitis 237.90 15.11 3106 671612 271592 89682137
Drug effective for unapproved indication 234.22 15.11 292 674426 7626 89946103
Lower respiratory tract infection 233.99 15.11 2874 671844 247785 89705944
Disorientation 231.55 15.11 28 674690 44086 89909643
Oedema peripheral 231.51 15.11 1059 673659 256856 89696873
Generalised tonic-clonic seizure 231.29 15.11 6 674712 34897 89918832
Skin exfoliation 231.01 15.11 108 674610 67805 89885924
Foetal exposure during pregnancy 228.75 15.11 26 674692 42949 89910780
Pulmonary embolism 228.18 15.11 389 674329 130431 89823298
Erythema 228.07 15.11 905 673813 228341 89725388
Hepatic function abnormal 227.36 15.11 36 674682 46252 89907477
Injection site pruritus 226.93 15.11 60 674658 53774 89899955
Liver function test increased 226.91 15.11 1238 673480 83617 89870112
Respiratory distress 224.78 15.11 17 674701 38929 89914800
Pulmonary hypertension 223.17 15.11 27 674691 42496 89911233
Dizziness 223.17 15.11 3068 671650 586216 89367513
Foot deformity 219.74 15.11 954 673764 58697 89895032
Abdominal pain 219.29 15.11 1887 672831 393834 89559895
Aphasia 217.90 15.11 30 674688 42782 89910947
Pneumonia aspiration 217.33 15.11 25 674693 40915 89912814
Dry skin 217.19 15.11 201 674517 87872 89865857
Hip arthroplasty 216.83 15.11 1131 673587 75077 89878652
Orthostatic hypotension 216.01 15.11 28 674690 41799 89911930
Urinary retention 213.59 15.11 18 674700 37726 89916003
Grip strength decreased 212.52 15.11 1297 673421 91279 89862450
Hypophagia 212.29 15.11 14 674704 35923 89917806
Respiratory arrest 209.19 15.11 9 674709 33302 89920427
Blood glucose increased 208.17 15.11 241 674477 95005 89858724
Chills 207.55 15.11 418 674300 131563 89822166
Hepatic failure 206.61 15.11 26 674692 39702 89914027
Hepatic cytolysis 206.06 15.11 5 674713 30911 89922818
Pallor 205.75 15.11 12 674706 34153 89919576
Psychotic disorder 204.60 15.11 6 674712 31224 89922505
Device issue 204.05 15.11 3 674715 29534 89924195
Hyperhidrosis 202.36 15.11 446 674272 135859 89817870
Heart rate decreased 201.55 15.11 73 674645 53432 89900297
Haematoma 199.59 15.11 27 674691 39021 89914708
Drug withdrawal syndrome 198.07 15.11 3 674715 28720 89925009
C-reactive protein increased 197.97 15.11 2144 672574 179245 89774484
Pulmonary fibrosis 196.54 15.11 1423 673295 106080 89847649
Cerebrovascular accident 196.18 15.11 389 674329 123144 89830585
Fatigue 195.89 15.11 10477 664241 1143546 88810183
Hypervolaemia 195.77 15.11 12 674706 32745 89920984
Cholelithiasis 195.48 15.11 73 674645 52433 89901296
Bone erosion 193.03 15.11 845 673873 52176 89901553
Cytokine release syndrome 192.57 15.11 3 674715 27970 89925759
Hepatocellular injury 191.80 15.11 5 674713 28953 89924776
Loss of consciousness 186.66 15.11 486 674232 139752 89813977
Hemiparesis 186.19 15.11 13 674705 31806 89921923
Diarrhoea 185.94 15.11 5450 669268 933740 89019989
Epistaxis 185.38 15.11 216 674502 84909 89868820
Headache 184.42 15.11 8014 666704 854732 89098997
Altered state of consciousness 184.17 15.11 13 674705 31519 89922210
Injection site haemorrhage 183.50 15.11 6 674712 28312 89925417
Disturbance in attention 183.09 15.11 61 674657 47048 89906681
Pericardial effusion 182.37 15.11 28 674690 36805 89916924
Eosinophilia 181.57 15.11 7 674711 28526 89925203
Bone marrow failure 177.92 15.11 17 674701 32204 89921525
Jaundice 177.34 15.11 18 674700 32499 89921230
Drug level increased 176.02 15.11 7 674711 27755 89925974
Blood alkaline phosphatase increased 175.41 15.11 69 674649 48010 89905719
Sinus tachycardia 174.86 15.11 9 674709 28504 89925225
Stevens-Johnson syndrome 174.85 15.11 11 674707 29365 89924364
Blood pressure fluctuation 174.22 15.11 86 674632 52327 89901402
Dyskinesia 173.71 15.11 31 674687 36503 89917226
Blood calcium decreased 171.87 15.11 14 674704 30168 89923561
Melaena 171.05 15.11 27 674691 34770 89918959
Obstructive airways disorder 169.36 15.11 5 674713 25864 89927865
Gait inability 168.63 15.11 1750 672968 144706 89809023
Ejection fraction decreased 168.58 15.11 6 674712 26247 89927482
Mycobacterium tuberculosis complex test positive 167.79 15.11 146 674572 2466 89951263
Coronary artery disease 167.76 15.11 25 674693 33598 89920131
Deep vein thrombosis 167.63 15.11 264 674454 91356 89862373
Sleep disorder 167.53 15.11 2230 672488 195800 89757929
Chronic obstructive pulmonary disease 166.59 15.11 182 674536 73647 89880082
Macular degeneration 166.48 15.11 39 674679 37931 89915798
Blood potassium decreased 163.72 15.11 75 674643 47652 89906077
Myocardial infarction 162.90 15.11 340 674378 105632 89848097
Anxiety 161.92 15.11 1499 673219 308273 89645456
Serotonin syndrome 160.12 15.11 42 674676 37845 89915884
Restlessness 160.00 15.11 35 674683 35685 89918044
Metastases to liver 159.59 15.11 15 674703 28792 89924937
Shock 159.39 15.11 15 674703 28763 89924966
Cardiogenic shock 159.21 15.11 5 674713 24463 89929266
Injection site bruising 159.05 15.11 96 674622 52211 89901518
Circulatory collapse 158.85 15.11 6 674712 24898 89928831
Blood creatinine increased 157.78 15.11 323 674395 101063 89852666
Arrhythmia 157.35 15.11 59 674659 42273 89911456
Adverse event 157.17 15.11 1448 673270 115970 89837759
Gamma-glutamyltransferase increased 156.77 15.11 44 674674 37908 89915821
Cerebral haemorrhage 156.31 15.11 33 674685 34489 89919240
Pyrexia 155.88 15.11 3736 670982 656749 89296980
Pancreatitis acute 155.44 15.11 26 674692 32089 89921640
Haematemesis 155.28 15.11 31 674687 33695 89920034
Nodule 154.71 15.11 494 674224 26192 89927537
Renal impairment 153.97 15.11 348 674370 105073 89848656
Pulmonary arterial hypertension 152.36 15.11 11 674707 26176 89927553
Colitis 151.73 15.11 178 674540 69764 89883965
Ventricular tachycardia 150.89 15.11 8 674710 24700 89929029
Electrolyte imbalance 150.50 15.11 6 674712 23739 89929990
Metastases to bone 150.47 15.11 10 674708 25495 89928234
Hallucination, visual 149.25 15.11 5 674713 23087 89930642
Pneumonia 148.12 15.11 3618 671100 634441 89319288
Septic shock 147.89 15.11 249 674469 83911 89869818
Face oedema 147.43 15.11 6 674712 23312 89930417
Emotional distress 146.87 15.11 45 674673 36617 89917112
Blood urea increased 146.36 15.11 25 674693 30388 89923341
Liver injury 145.60 15.11 1924 672794 168643 89785086
Blood pressure systolic increased 144.03 15.11 133 674585 58212 89895517
Paraesthesia oral 143.89 15.11 30 674688 31629 89922100
Tachypnoea 143.76 15.11 3 674715 21306 89932423
Angina pectoris 143.19 15.11 56 674662 39104 89914625
Blood parathyroid hormone decreased 143.11 15.11 295 674423 11921 89941808
Tenderness 142.88 15.11 483 674235 26385 89927344
Procedural pain 142.87 15.11 36 674682 33324 89920405
Transient ischaemic attack 141.76 15.11 72 674646 43104 89910625
Full blood count decreased 141.57 15.11 25 674693 29664 89924065
Vaginal haemorrhage 141.37 15.11 30 674688 31241 89922488
Joint injury 141.30 15.11 549 674169 32115 89921614
Neurotoxicity 141.09 15.11 4 674714 21463 89932266
Eczema 140.90 15.11 112 674606 52758 89900971
Injury 140.44 15.11 2156 672562 195193 89758536
Memory impairment 140.42 15.11 2155 672563 195089 89758640
Aggression 139.78 15.11 17 674701 26651 89927078
Granuloma skin 139.62 15.11 270 674448 10410 89943319
Upper gastrointestinal haemorrhage 138.57 15.11 8 674710 22968 89930761
Mitral valve incompetence 138.47 15.11 7 674711 22517 89931212
Vertigo 137.62 15.11 191 674527 69620 89884109
Leukocytosis 137.52 15.11 31 674687 30959 89922770
Acute respiratory distress syndrome 137.13 15.11 24 674694 28662 89925067
Dysgeusia 136.77 15.11 114 674604 52446 89901283
Intentional product use issue 136.23 15.11 2321 672397 214571 89739158
Lower limb fracture 136.14 15.11 1091 673627 83922 89869807
Upper respiratory tract infection 135.94 15.11 1508 673210 126810 89826919
Intestinal obstruction 135.93 15.11 53 674665 37078 89916651
Product administration error 135.70 15.11 18 674700 26405 89927324
Injection site mass 135.38 15.11 7 674711 22083 89931646
Lip swelling 135.06 15.11 59 674659 38551 89915178
Infusion site pain 132.29 15.11 3 674715 19735 89933994
Weight increased 132.21 15.11 4059 670659 413868 89539861
Swollen tongue 132.00 15.11 90 674628 45866 89907863
Dermatitis atopic 130.63 15.11 12 674706 23460 89930269
Abnormal behaviour 130.24 15.11 10 674708 22618 89931111
Coordination abnormal 130.15 15.11 7 674711 21349 89932380
Facet joint syndrome 129.99 15.11 1210 673508 97179 89856550
Bursitis 129.05 15.11 1524 673194 130130 89823599
Acne 128.13 15.11 485 674233 28022 89925707
Lip dry 127.63 15.11 1230 673488 99725 89854004
Device malfunction 127.45 15.11 7 674711 20970 89932759
Urinary incontinence 127.35 15.11 60 674658 37506 89916223
Diabetic ketoacidosis 126.85 15.11 16 674702 24391 89929338
Bronchospasm 125.55 15.11 7 674711 20702 89933027
Haemoptysis 124.58 15.11 46 674672 33274 89920455
Contusion 124.55 15.11 2592 672126 248624 89705105
Ischaemic stroke 124.25 15.11 11 674707 22155 89931574
Diplopia 122.94 15.11 31 674687 28683 89925046
Decreased appetite 121.47 15.11 2021 672697 374519 89579210
Panniculitis 121.38 15.11 306 674412 14152 89939577
Acute myocardial infarction 120.96 15.11 54 674664 34836 89918893
Myoclonus 120.96 15.11 5 674713 19163 89934566
Swelling face 120.05 15.11 267 674451 81085 89872644
Hypothyroidism 119.82 15.11 131 674587 52996 89900733
Haematuria 119.68 15.11 55 674663 34882 89918847
Tubulointerstitial nephritis 119.42 15.11 22 674696 25321 89928408
Cerebral infarction 119.24 15.11 26 674692 26570 89927159
Osteoporosis 118.06 15.11 1168 673550 95363 89858366
Psoriatic arthropathy 117.49 15.11 2369 672349 225966 89727763
Adverse drug reaction 117.07 15.11 1357 673361 115344 89838385
Drug tolerance decreased 116.90 15.11 512 674206 31618 89922111
Metastases to central nervous system 116.29 15.11 3 674715 17539 89936190
Dry mouth 115.32 15.11 1969 672749 182090 89771639
Bacteraemia 114.98 15.11 15 674703 22285 89931444
Blood lactate dehydrogenase increased 114.95 15.11 26 674692 25906 89927823
Irritability 114.82 15.11 61 674657 35601 89918128
Lymphocyte count decreased 114.25 15.11 59 674659 34991 89918738
Rash maculo-papular 113.83 15.11 83 674635 40850 89912879
Ataxia 112.88 15.11 5 674713 18037 89935692
Gastric disorder 111.00 15.11 518 674200 32866 89920863
Maternal exposure during pregnancy 110.37 15.11 3484 671234 356579 89597150
Malnutrition 110.30 15.11 7 674711 18551 89935178
Disseminated intravascular coagulation 109.82 15.11 15 674703 21523 89932206
Withdrawal syndrome 109.53 15.11 18 674700 22506 89931223
Myelodysplastic syndrome 107.92 15.11 14 674704 20889 89932840
Visual acuity reduced 106.77 15.11 22 674696 23388 89930341
Hemiplegia 106.25 15.11 3 674715 16157 89937572
Subdural haematoma 106.20 15.11 4 674714 16641 89937088
Acute myeloid leukaemia 106.14 15.11 14 674704 20626 89933103
Productive cough 105.66 15.11 263 674455 76800 89876929
Joint dislocation 105.08 15.11 629 674089 43953 89909776
Brain oedema 105.01 15.11 6 674712 17379 89936350
Creatinine renal clearance decreased 104.27 15.11 10 674708 18889 89934840
Right ventricular failure 103.78 15.11 11 674707 19194 89934535
Product substitution issue 103.53 15.11 8 674710 18000 89935729
Tricuspid valve incompetence 103.49 15.11 5 674713 16726 89937003
Full blood count abnormal 103.35 15.11 73 674645 36524 89917205
Prescribed overdose 103.25 15.11 1147 673571 96478 89857251
X-ray abnormal 102.70 15.11 634 674084 44790 89908939
Hypothermia 102 15.11 3 674715 15572 89938157
Coagulopathy 101.94 15.11 24 674694 23265 89930464
Presyncope 101.52 15.11 55 674663 31750 89921979
Peripheral venous disease 101.45 15.11 1013 673705 82908 89870821
Body temperature increased 101.10 15.11 110 674608 44600 89909129
Cyanosis 100.51 15.11 13 674705 19442 89934287
Complication associated with device 100.47 15.11 13 674705 19436 89934293
Female genital tract fistula 99.80 15.11 9 674709 17859 89935870
Thrombotic microangiopathy 99.70 15.11 4 674714 15739 89937990
Joint effusion 99.28 15.11 348 674370 19362 89934367
Ileus 99.06 15.11 6 674712 16540 89937189
Intentional product misuse 99.02 15.11 1062 673656 88542 89865187
Blood pressure diastolic decreased 98.68 15.11 38 674680 26788 89926941
Diabetes mellitus inadequate control 97.71 15.11 12 674706 18672 89935057
Extrapyramidal disorder 97.34 15.11 6 674712 16297 89937432
Radiculopathy 96.49 15.11 12 674706 18493 89935236
Chronic kidney disease 96.27 15.11 140 674578 50051 89903678
Progressive multifocal leukoencephalopathy 95.81 15.11 5 674713 15650 89938079
Respiratory rate increased 95.21 15.11 6 674712 15995 89937734
Polyneuropathy 95.08 15.11 15 674703 19326 89934403
Hallucination, auditory 95.02 15.11 6 674712 15969 89937760
Cellulitis 94.99 15.11 354 674364 90983 89862746
Clostridium difficile colitis 94.70 15.11 40 674678 26666 89927063
Sleep apnoea syndrome 94.12 15.11 60 674658 31687 89922042
Blood sodium decreased 93.76 15.11 44 674674 27569 89926160
Neck pain 93.70 15.11 1277 673441 112686 89841043
Speech disorder 93.62 15.11 121 674597 45464 89908265
Anaphylactic shock 93.40 15.11 60 674658 31557 89922172
No adverse event 93.21 15.11 232 674486 67750 89885979
Sciatica 92.98 15.11 1159 673559 100223 89853506
Alanine aminotransferase increased 92.32 15.11 510 674208 117828 89835901
Cardiomegaly 92.31 15.11 15 674703 18910 89934819
Abdominal pain lower 92.29 15.11 55 674663 30122 89923607
Haematocrit decreased 91.22 15.11 106 674612 41726 89912003
Ventricular fibrillation 90.91 15.11 3 674715 14041 89939688
Gastritis 90.84 15.11 106 674612 41647 89912082
Small intestinal obstruction 90.76 15.11 23 674695 21211 89932518
Haemorrhage 90.30 15.11 243 674475 69126 89884603
Needle issue 90.12 15.11 3 674715 13931 89939798
Exostosis 89.52 15.11 690 674028 52444 89901285
Delusion 89.44 15.11 3 674715 13837 89939892
Unevaluable event 89.41 15.11 170 674548 54678 89899051
Rash erythematous 88.62 15.11 223 674495 64881 89888848
Finger deformity 88.61 15.11 481 674237 32416 89921313
Deformity 88.35 15.11 244 674474 11926 89941803
Wound infection 88.18 15.11 1194 673524 105208 89848521
Mania 88.08 15.11 4 674714 14120 89939609
Device related infection 87.70 15.11 41 674677 25745 89927984
Injection site rash 87.67 15.11 35 674683 24138 89929591
Dysphonia 87.49 15.11 214 674504 62870 89890859
Aspartate aminotransferase increased 87.38 15.11 431 674287 102506 89851223
Vaginal discharge 87.32 15.11 19 674699 19445 89934284
Oral candidiasis 87.29 15.11 81 674637 35374 89918355
Sensory loss 86.67 15.11 15 674703 18060 89935669
Lymphopenia 86.54 15.11 31 674687 22850 89930879
Cytomegalovirus infection 86.38 15.11 45 674673 26557 89927172
Muscle rigidity 86.24 15.11 5 674713 14304 89939425
Hyperthyroidism 86.05 15.11 16 674702 18294 89935435
Spinal operation 85.81 15.11 216 674502 9980 89943749
Throat tightness 85.67 15.11 57 674661 29427 89924302
Schizophrenia 84.69 15.11 7 674711 14907 89938822
Deep vein thrombosis postoperative 84.27 15.11 852 673866 69957 89883772
Poisoning 84.09 15.11 8 674710 15209 89938520
Chronic sinusitis 83.84 15.11 36 674682 23766 89929963
Bone pain 83.83 15.11 213 674505 61770 89891959
Prescribed underdose 83.76 15.11 891 673827 74128 89879601
Liver disorder 83.60 15.11 1318 673400 119951 89833778
Road traffic accident 82.84 15.11 1192 673526 106434 89847295
Lung disorder 82.43 15.11 1571 673147 148312 89805417
Injection site urticaria 81.99 15.11 17 674701 17994 89935735
Poor venous access 81.85 15.11 22 674696 19505 89934224
Obesity 81.79 15.11 1170 673548 104337 89849392
Mental disorder 81.76 15.11 72 674646 32246 89921483
Infusion site erythema 81.71 15.11 5 674713 13665 89940064
Blood pressure increased 81.68 15.11 1007 673711 196210 89757519
Cough 81.67 15.11 2106 672612 366856 89586873
Hypercholesterolaemia 81.50 15.11 1127 673591 99765 89853964
Rales 80.75 15.11 11 674707 15816 89937913
Transfusion 80.66 15.11 16 674702 17472 89936257
Nail disorder 80.31 15.11 731 673987 58336 89895393
Osteonecrosis 80.00 15.11 48 674670 26193 89927536
Therapy non-responder 79.73 15.11 1446 673272 135258 89818471
Onychomycosis 79.73 15.11 514 674204 36862 89916867
Labelled drug-drug interaction medication error 79.71 15.11 8 674710 14574 89939155
Acute generalised exanthematous pustulosis 79.02 15.11 6 674712 13697 89940032
Treatment noncompliance 78.61 15.11 167 674551 51560 89902169
Muscle twitching 78.50 15.11 41 674677 24161 89929568
Blood magnesium decreased 77.53 15.11 12 674706 15681 89938048
Heavy menstrual bleeding 77.33 15.11 28 674690 20502 89933227
Hospitalisation 77.14 15.11 597 674121 127503 89826226
Drug resistance 76.83 15.11 68 674650 30381 89923348
Blood creatine phosphokinase increased 76.60 15.11 84 674634 33939 89919790
Panic attack 76.57 15.11 51 674667 26314 89927415
Immune thrombocytopenia 76.38 15.11 6 674712 13320 89940409
Cholecystitis 75.70 15.11 17 674701 17023 89936706
Night sweats 75.44 15.11 1363 673355 127403 89826326
Subarachnoid haemorrhage 75.37 15.11 20 674698 17884 89935845
Myopathy 74.99 15.11 7 674711 13511 89940218
Knee operation 74.87 15.11 162 674556 6774 89946955
Erythema multiforme 74.67 15.11 4 674714 12242 89941487
Pneumonitis 74.57 15.11 134 674584 44036 89909693
Blood albumin decreased 74.18 15.11 17 674701 16786 89936943
Tenosynovitis 74.07 15.11 258 674460 14309 89939420
Haemorrhage intracranial 73.99 15.11 12 674706 15150 89938579
Central nervous system lesion 73.62 15.11 3 674715 11643 89942086
Therapy partial responder 73.51 15.11 36 674682 22007 89931722
Eye pruritus 73.03 15.11 65 674653 28962 89924767
Hypovolaemia 72.96 15.11 5 674713 12426 89941303
Multiple sclerosis 72.90 15.11 60 674658 27780 89925949
Motor dysfunction 72.82 15.11 26 674692 19204 89934525
Autoimmune disorder 72.81 15.11 883 673835 75861 89877868
Accidental overdose 72.72 15.11 62 674656 28211 89925518
Lung infiltration 72.58 15.11 13 674705 15269 89938460
Musculoskeletal disorder 72.53 15.11 338 674380 21431 89932298
Ulcer 72.49 15.11 456 674262 32426 89921303
Generalised oedema 71.74 15.11 26 674692 19027 89934702
Breast cancer metastatic 71.59 15.11 13 674705 15119 89938610
Joint laxity 71.54 15.11 93 674625 2535 89951194
Spinal stenosis 71.44 15.11 288 674430 17136 89936593
Device breakage 71.09 15.11 10 674708 14034 89939695
Injection site warmth 71.06 15.11 21 674697 17494 89936235
Blood pressure systolic abnormal 70.97 15.11 28 674690 19450 89934279
General physical health deterioration 70.93 15.11 3278 671440 351837 89601892
Troponin increased 70.77 15.11 8 674710 13273 89940456
Chest pain 70.59 15.11 1825 672893 317820 89635909
Gangrene 70.55 15.11 7 674711 12869 89940860
Myalgia 70.34 15.11 900 673818 174225 89779504
Dislocation of vertebra 70.27 15.11 681 674037 55287 89898442
Fear of injection 70.21 15.11 179 674539 8336 89945393
Feeling cold 69.71 15.11 61 674657 27404 89926325
Myocardial ischaemia 69.54 15.11 10 674708 13804 89939925
Eosinophil count increased 69.40 15.11 8 674710 13073 89940656
Pre-eclampsia 69.32 15.11 3 674715 11045 89942684
Pruritus 69.01 15.11 3311 671407 538214 89415515
Anhedonia 68.88 15.11 4 674714 11427 89942302
Foot operation 68.88 15.11 184 674534 8817 89944912
Hypotonia 68.84 15.11 4 674714 11422 89942307
Blood pressure diastolic abnormal 68.56 15.11 31 674687 19850 89933879
Proctitis 68.24 15.11 15 674703 15244 89938485
Dialysis 68.15 15.11 4 674714 11325 89942404
Hypoaesthesia 68.14 15.11 2925 671793 311285 89642444
Nasal polyps 68.12 15.11 3 674715 10877 89942852
Skin necrosis 67.86 15.11 278 674440 16663 89937066
Pyelonephritis 67.83 15.11 37 674681 21279 89932450
Proteinuria 67.71 15.11 45 674673 23246 89930483
Acute coronary syndrome 67.64 15.11 3 674715 10810 89942919
Product storage error 67.58 15.11 33 674685 20208 89933521
Cardiomyopathy 67.38 15.11 33 674685 20173 89933556
Petechiae 67.38 15.11 17 674701 15724 89938005
Adjustment disorder with depressed mood 67.11 15.11 682 674036 56071 89897658
Therapeutic product effect delayed 67.03 15.11 107 674611 3534 89950195
Immune system disorder 66.85 15.11 218 674500 11687 89942042
Malaise 66.76 15.11 5145 669573 580841 89372888
Rhinitis allergic 66.52 15.11 21 674697 16764 89936965
Stress cardiomyopathy 66.46 15.11 10 674708 13345 89940384
Joint noise 65.83 15.11 131 674587 5159 89948570
Throat irritation 65.34 15.11 168 674550 48527 89905202
Metastases to lung 65.19 15.11 19 674699 15972 89937757
Escherichia urinary tract infection 65.08 15.11 12 674706 13803 89939926
Hypocalcaemia 65.04 15.11 136 674582 42232 89911497
Gastroenteritis 64.89 15.11 73 674645 29156 89924573
Drug tolerance 64.79 15.11 285 674433 17631 89936098
Hydronephrosis 64.77 15.11 8 674710 12394 89941335
Dysuria 64.33 15.11 122 674596 39279 89914450
Dermatitis bullous 64.08 15.11 3 674715 10313 89943416
Abortion induced 63.75 15.11 7 674711 11881 89941848
Supraventricular tachycardia 63.74 15.11 21 674697 16315 89937414
Drug dose omission by device 63.47 15.11 3 674715 10228 89943501
Peritonitis 63.00 15.11 34 674684 19671 89934058
Myocarditis 62.91 15.11 13 674705 13793 89939936
Psychomotor hyperactivity 62.84 15.11 10 674708 12803 89940926
Transplant rejection 62.48 15.11 10 674708 12748 89940981
Lacrimation increased 61.83 15.11 66 674652 26996 89926733
Leukopenia 61.74 15.11 467 674251 100243 89853486
Cardiac failure acute 61.56 15.11 8 674710 11921 89941808
Splenomegaly 61.37 15.11 11 674707 12913 89940816
Eating disorder 61.36 15.11 71 674647 28002 89925727
Purpura 61.28 15.11 17 674701 14761 89938968
Lupus vulgaris 60.93 15.11 557 674161 44502 89909227
Product preparation error 60.60 15.11 4 674714 10257 89943472
Prothrombin time prolonged 60.19 15.11 3 674715 9769 89943960
Metastases to lymph nodes 59.93 15.11 8 674710 11681 89942048
Renal tubular necrosis 59.88 15.11 17 674701 14538 89939191
Blood loss anaemia 59.74 15.11 4 674714 10136 89943593
Blood glucose decreased 59.50 15.11 52 674666 23377 89930352
Hepatitis acute 59.44 15.11 6 674712 10881 89942848
Asthma 59.35 15.11 1361 673357 240799 89712930
Adjustment disorder 59.26 15.11 3 674715 9639 89944090
Skin laceration 58.92 15.11 64 674654 25971 89927758
Impaired work ability 58.57 15.11 292 674426 19034 89934695
Lipase increased 58.44 15.11 7 674711 11104 89942625
Eye pain 58.03 15.11 154 674564 44014 89909715
Nephropathy toxic 57.71 15.11 12 674706 12676 89941053
Pulmonary toxicity 57.57 15.11 203 674515 11328 89942401
Gestational diabetes 57.34 15.11 6 674712 10576 89943153
Eye swelling 57.31 15.11 81 674637 29305 89924424
Product use in unapproved indication 56.83 15.11 1990 672728 334246 89619483
Body temperature decreased 56.78 15.11 56 674662 23760 89929969
Hypertension 56.76 15.11 4045 670673 453487 89500242
Coeliac disease 56.59 15.11 544 674174 44066 89909663
Oral mucosal exfoliation 56.46 15.11 68 674650 1712 89952017
Aspiration 56.46 15.11 23 674695 15670 89938059
Product administration interrupted 56.43 15.11 12 674706 12480 89941249
Joint destruction 56.39 15.11 222 674496 13065 89940664
Arterial occlusive disease 56.14 15.11 12 674706 12434 89941295
Atrial flutter 56.04 15.11 7 674711 10751 89942978
Anti-cyclic citrullinated peptide antibody 56.02 15.11 371 674347 26850 89926879
Hypoaesthesia oral 55.90 15.11 23 674695 15577 89938152
Acute pulmonary oedema 55.80 15.11 4 674714 9576 89944153
Haemolytic anaemia 55.44 15.11 10 674708 11687 89942042
Head injury 55.04 15.11 92 674626 31096 89922633
Haematotoxicity 54.70 15.11 13 674705 12522 89941207
Sneezing 54.69 15.11 86 674632 29783 89923946
Rebound effect 54.43 15.11 4 674714 9380 89944349
Pancreatitis 54.41 15.11 301 674417 69525 89884204
Nervousness 54.25 15.11 107 674611 33949 89919780
Fear 54.15 15.11 28 674690 16594 89937135
Transaminases increased 54.10 15.11 123 674595 37069 89916660
Urosepsis 54.07 15.11 47 674671 21185 89932544
Skin haemorrhage 53.64 15.11 48 674670 21332 89932397
Ventricular extrasystoles 53.55 15.11 16 674702 13234 89940495
Restless legs syndrome 53.38 15.11 53 674665 22417 89931312
Intermenstrual bleeding 53.30 15.11 4 674714 9219 89944510
Influenza like illness 53.18 15.11 366 674352 80245 89873484
Pseudomonas infection 53.13 15.11 22 674696 14843 89938886
Retinitis 52.81 15.11 477 674241 37981 89915748
Onychomadesis 52.60 15.11 549 674169 45449 89908280
Sudden death 52.42 15.11 9 674709 10900 89942829
Hepatitis B virus test positive 51.96 15.11 28 674690 202 89953527
Burning sensation 51.95 15.11 269 674449 63183 89890546
Enterocolitis 51.87 15.11 8 674710 10482 89943247
Hereditary angioedema 51.55 15.11 5 674713 9360 89944369
Rheumatoid lung 51.53 15.11 102 674616 4001 89949728
Exposure during pregnancy 51.34 15.11 1366 673352 237044 89716685
Urine output decreased 51.33 15.11 15 674703 12588 89941141
Skin fissures 50.69 15.11 48 674670 20761 89932968
Pneumothorax 50.57 15.11 41 674677 19126 89934603
Breast cancer stage III 50.55 15.11 897 673821 83550 89870179
Dementia 50.39 15.11 62 674656 23799 89929930
Lupus-like syndrome 50.31 15.11 571 674147 48275 89905454
White blood cell count increased 50.16 15.11 294 674424 66947 89886782
Anger 49.54 15.11 20 674698 13700 89940029
Neoplasm malignant 49.52 15.11 426 674292 33454 89920275
Incontinence 49.47 15.11 19 674699 13416 89940313
Contrast media allergy 49.28 15.11 85 674633 2996 89950733
Atrial septal defect 49.25 15.11 3 674715 8231 89945498
Laryngitis 49.03 15.11 586 674132 50167 89903562
Back disorder 48.97 15.11 343 674375 25288 89928441
Insurance issue 48.54 15.11 11 674707 10947 89942782
Eyelid oedema 48.33 15.11 13 674705 11521 89942208
Lower gastrointestinal haemorrhage 48.29 15.11 5 674713 8887 89944842
Cardiovascular disorder 48.17 15.11 20 674698 13472 89940257
Skin burning sensation 48.05 15.11 45 674673 19566 89934163
Arteriosclerosis 47.87 15.11 11 674707 10842 89942887
Encephalitis 47.70 15.11 12 674706 11122 89942607
Post procedural haemorrhage 47.64 15.11 5 674713 8793 89944936
Blood thyroid stimulating hormone increased 47.58 15.11 6 674712 9149 89944580
Hypersomnia 47.55 15.11 54 674664 21477 89932252
Glomerular filtration rate decreased 47.51 15.11 34 674684 16898 89936831
Blood lactic acid increased 47.50 15.11 5 674713 8773 89944956
Nightmare 47.42 15.11 55 674663 21670 89932059
Heart rate irregular 47.22 15.11 67 674651 24201 89929528
Gait disturbance 47.00 15.11 2381 672337 258115 89695614
Personality disorder 46.82 15.11 17 674701 12427 89941302
Cardiac murmur 46.67 15.11 40 674678 18154 89935575
Skin cancer 46.59 15.11 212 674506 13307 89940422
Electrocardiogram abnormal 46.30 15.11 10 674708 10288 89943441
Sputum discoloured 46.29 15.11 50 674668 20341 89933388
Tinnitus 46.16 15.11 165 674553 42937 89910792
End stage renal disease 46.08 15.11 5 674713 8566 89945163
Renal injury 45.95 15.11 10 674708 10233 89943496
Aortic arteriosclerosis 45.36 15.11 3 674715 7681 89946048
Staphylococcal infection 45.14 15.11 196 674522 48243 89905486
C-reactive protein 45.11 15.11 393 674325 30974 89922755
Haemorrhoids 45.08 15.11 81 674637 26621 89927108
Systemic lupus erythematosus rash 45.07 15.11 71 674647 2318 89951411
Disability 45.04 15.11 483 674235 40262 89913467
Cardiac disorder 44.95 15.11 244 674474 56628 89897101
Tuberculosis 44.91 15.11 199 674519 12350 89941379
Eyelid ptosis 44.24 15.11 7 674711 8999 89944730
Arteriosclerosis coronary artery 43.85 15.11 9 674709 9594 89944135
Peripheral sensory neuropathy 43.65 15.11 8 674710 9242 89944487
Injection site induration 43.49 15.11 12 674706 10456 89943273
Synovial disorder 43.44 15.11 81 674637 3037 89950692
Apathy 43.42 15.11 14 674704 11026 89942703
Polyarthritis 43.30 15.11 259 674459 18091 89935638
Pelvic pain 42.88 15.11 31 674687 15326 89938403
Blood calcium increased 42.85 15.11 18 674700 12040 89941689
Ecchymosis 42.83 15.11 19 674699 12304 89941425
Muscle spasticity 42.82 15.11 128 674590 35194 89918535
Red blood cell sedimentation rate 42.73 15.11 102 674616 4556 89949173
Epstein-Barr virus infection 42.71 15.11 12 674706 10332 89943397
Salivary hypersecretion 42.61 15.11 8 674710 9084 89944645
Cholecystitis acute 42.55 15.11 9 674709 9395 89944334
Amenorrhoea 42.46 15.11 17 674701 11705 89942024
Neutrophil count increased 42.42 15.11 49 674669 19341 89934388
Partial seizures 42.38 15.11 3 674715 7257 89946472
Erysipelas 42.35 15.11 8 674710 9044 89944685
Faeces discoloured 42.34 15.11 58 674660 21262 89932467
Unintended pregnancy 42.24 15.11 4 674714 7633 89946096
Atelectasis 42.15 15.11 73 674645 24336 89929393
Nystagmus 42.15 15.11 3 674715 7224 89946505
Aspergillus infection 42.08 15.11 14 674704 10809 89942920
Cerebral ischaemia 41.93 15.11 3 674715 7193 89946536
Seronegative arthritis 41.53 15.11 255 674463 17979 89935750
Wrist deformity 41.28 15.11 81 674637 3157 89950572
Hypogammaglobulinaemia 41.16 15.11 14 674704 10660 89943069
Abdominal pain upper 41.02 15.11 2940 671778 329734 89623995
Haemolysis 40.94 15.11 7 674711 8503 89945226
Multiple drug therapy 40.62 15.11 3 674715 7006 89946723
Oesophagitis 40.61 15.11 41 674677 17208 89936521
Eye irritation 40.57 15.11 124 674594 33854 89919875
Red blood cell count decreased 40.53 15.11 192 674526 46159 89907570
Rash macular 40.22 15.11 105 674613 30175 89923554
Pruritus allergic 40.21 15.11 57 674661 1691 89952038
Diastolic dysfunction 40.14 15.11 4 674714 7329 89946400
Depressed mood 40.14 15.11 560 674158 49662 89904067
Pulmonary haemorrhage 39.88 15.11 6 674712 8007 89945722
Ovarian cyst 39.83 15.11 42 674676 17276 89936453
Pre-existing condition improved 39.56 15.11 154 674564 9015 89944714
Orthopnoea 39.40 15.11 3 674715 6832 89946897
Blindness 39.35 15.11 87 674631 26481 89927248
Intestinal ischaemia 39.19 15.11 9 674709 8874 89944855
Short stature 39.16 15.11 44 674674 1026 89952703
Hypertriglyceridaemia 39.05 15.11 6 674712 7883 89945846
Bronchopulmonary aspergillosis 38.95 15.11 18 674700 11380 89942349
Anticipatory anxiety 38.94 15.11 47 674671 1186 89952543
Diverticulum intestinal 38.89 15.11 10 674708 9132 89944597
Elbow deformity 38.86 15.11 52 674666 1459 89952270
Dermatitis 38.79 15.11 66 674652 22154 89931575
Vitamin B12 deficiency 38.68 15.11 5 674713 7481 89946248
Hyperventilation 38.65 15.11 3 674715 6725 89947004
Feeding disorder 38.59 15.11 44 674674 17468 89936261
Cold sweat 38.57 15.11 29 674689 14052 89939677
Fistula 38.44 15.11 21 674697 12068 89941661
Walking aid user 38.37 15.11 419 674299 35087 89918642
Odynophagia 38.26 15.11 10 674708 9033 89944696
Therapeutic response shortened 38.09 15.11 70 674648 22809 89930920
Candida infection 38.07 15.11 128 674590 33929 89919800
Immune reconstitution inflammatory syndrome 37.98 15.11 4 674714 7015 89946714
Mental impairment 37.95 15.11 41 674677 16679 89937050
Facial paralysis 37.64 15.11 36 674682 15498 89938231
Lipids increased 37.61 15.11 48 674670 1284 89952445
Hiatus hernia 37.60 15.11 83 674635 25278 89928451
Blepharospasm 37.59 15.11 601 674117 54844 89898885
Synovial cyst 37.35 15.11 180 674538 11572 89942157
Joint arthroplasty 37.29 15.11 81 674637 3396 89950333
Drug effect less than expected 36.83 15.11 115 674603 6023 89947706
Atrioventricular block 36.82 15.11 10 674708 8805 89944924
Arthrodesis 36.78 15.11 74 674644 2938 89950791
Staphylococcal sepsis 36.72 15.11 12 674706 9371 89944358
Clostridium difficile infection 36.69 15.11 142 674576 36103 89917626
Metabolic disorder 36.26 15.11 6 674712 7464 89946265
Influenza 36.11 15.11 1322 673396 137942 89815787
Escherichia infection 36.05 15.11 39 674679 15856 89937873
Dermatitis contact 35.97 15.11 29 674689 13566 89940163
Trigger finger 35.90 15.11 102 674616 5068 89948661
Brain injury 35.86 15.11 7 674711 7731 89945998
Neck deformity 35.81 15.11 61 674657 2128 89951601
Hepatomegaly 35.79 15.11 28 674690 13298 89940431
Blood chloride decreased 35.79 15.11 3 674715 6316 89947413
Peptic ulcer haemorrhage 35.75 15.11 43 674675 1081 89952648
Polyuria 35.66 15.11 15 674703 10025 89943704
Personality change 35.27 15.11 6 674712 7315 89946414
Tooth infection 35.13 15.11 264 674454 19906 89933823
Cytopenia 35.13 15.11 47 674671 17402 89936327
Maternal exposure during breast feeding 35.10 15.11 3 674715 6217 89947512
Adverse reaction 35.10 15.11 357 674361 29355 89924374
Skin discolouration 35.09 15.11 190 674528 44125 89909604
Breast cancer 35.01 15.11 245 674473 53516 89900213
Nasal oedema 35.00 15.11 4 674714 6580 89947149
Feeling abnormal 34.99 15.11 962 673756 166273 89787456
Device failure 34.70 15.11 5 674713 6892 89946837
Laryngeal oedema 34.60 15.11 5 674713 6876 89946853
Ear infection 34.54 15.11 720 673998 69055 89884674
Dyspepsia 34.45 15.11 1805 672913 196355 89757374
Rectal haemorrhage 34.42 15.11 422 674296 82322 89871407
Chromaturia 34.41 15.11 56 674662 19131 89934598
Blood pressure systolic decreased 34.32 15.11 13 674705 9257 89944472
Soft tissue disorder 34.15 15.11 89 674629 4201 89949528
Intracranial pressure increased 34.13 15.11 5 674713 6806 89946923
Periorbital oedema 34.05 15.11 5 674713 6794 89946935
Embolism 33.94 15.11 14 674704 9467 89944262
Ankle arthroplasty 33.91 15.11 69 674649 2762 89950967
Therapeutic product effect variable 33.66 15.11 49 674669 1490 89952239
Loss of employment 33.66 15.11 71 674647 2916 89950813
Brain natriuretic peptide increased 33.60 15.11 3 674715 6002 89947727
Papule 33.57 15.11 9 674709 7993 89945736
Pulmonary alveolar haemorrhage 33.56 15.11 3 674715 5995 89947734
Anal incontinence 33.41 15.11 43 674675 16187 89937542
Glycosylated haemoglobin increased 33.32 15.11 40 674678 15522 89938207
Dizziness postural 33.01 15.11 13 674705 9040 89944689
Bundle branch block left 32.83 15.11 9 674709 7876 89945853
Nodal osteoarthritis 32.78 15.11 39 674679 969 89952760
Renal cyst 32.58 15.11 29 674689 12921 89940808
Extremity contracture 32.49 15.11 44 674674 1249 89952480
Failure to thrive 32.49 15.11 11 674707 8400 89945329
Wrong technique in device usage process 32.42 15.11 3 674715 5832 89947897
Skin irritation 32.41 15.11 32 674686 13571 89940158
Blood potassium increased 32.36 15.11 66 674652 20683 89933046
Drug level decreased 32.28 15.11 16 674702 9714 89944015
Multiple fractures 32.25 15.11 149 674569 9413 89944316
Skin plaque 32.20 15.11 17 674701 9958 89943771
Inflammatory marker increased 32.13 15.11 145 674573 9069 89944660
Root canal infection 32.03 15.11 26 674692 397 89953332
Abnormal loss of weight 31.98 15.11 6 674712 6817 89946912
Metastasis 31.95 15.11 4 674714 6133 89947596
Product complaint 31.89 15.11 32 674686 13468 89940261
Sarcoidosis 31.87 15.11 20 674698 10653 89943076
Head discomfort 31.87 15.11 45 674673 16288 89937441
Endocarditis 31.79 15.11 7 674711 7106 89946623
Refusal of treatment by patient 31.75 15.11 3 674715 5735 89947994
Thirst 31.69 15.11 45 674673 16250 89937479
Hypovolaemic shock 31.67 15.11 7 674711 7087 89946642
Hydrocephalus 31.66 15.11 4 674714 6090 89947639
Sensory disturbance 31.56 15.11 41 674677 15372 89938357
Amylase increased 31.53 15.11 7 674711 7065 89946664
Wrong product administered 31.44 15.11 9 674709 7656 89946073
Compression fracture 31.43 15.11 13 674705 8776 89944953
Hot flush 31.39 15.11 287 674431 59201 89894528
Pulse absent 31.39 15.11 4 674714 6051 89947678
Cardiac failure chronic 31.12 15.11 3 674715 5643 89948086
Seborrhoea 31.11 15.11 29 674689 538 89953191
Sleep disorder due to a general medical condition 31.08 15.11 200 674518 44538 89909191
Live birth 31.00 15.11 790 673928 78317 89875412
Protein urine present 30.96 15.11 7 674711 6977 89946752
Cytomegalovirus viraemia 30.95 15.11 9 674709 7577 89946152
Limb deformity 30.89 15.11 84 674634 4068 89949661
Maternal exposure before pregnancy 30.83 15.11 23 674695 11190 89942539
Mood altered 30.78 15.11 50 674668 17094 89936635
Respiratory tract infection 30.75 15.11 286 674432 58792 89894937
Aortic valve incompetence 30.68 15.11 6 674712 6618 89947111
SLE arthritis 30.65 15.11 32 674686 685 89953044
Lymphadenopathy 30.60 15.11 207 674511 45568 89908161
Aphthous ulcer 30.50 15.11 51 674667 17236 89936493
Staphylococcal bacteraemia 30.22 15.11 9 674709 7460 89946269
Cystitis haemorrhagic 30.20 15.11 3 674715 5510 89948219
Visual field defect 30.17 15.11 8 674710 7158 89946571
Hyperlipidaemia 30.03 15.11 80 674638 22836 89930893
Tongue oedema 29.79 15.11 3 674715 5451 89948278
Drug level below therapeutic 29.76 15.11 4 674714 5810 89947919
Rotator cuff repair 29.62 15.11 60 674658 2394 89951335
Pustular psoriasis 29.62 15.11 238 674480 18318 89935411
Tachyarrhythmia 29.46 15.11 3 674715 5403 89948326
Pneumocystis jirovecii pneumonia 29.44 15.11 74 674644 21542 89932187
Hyperuricaemia 29.26 15.11 7 674711 6712 89947017
Left ventricular failure 29.14 15.11 7 674711 6693 89947036
Hypertensive crisis 29.09 15.11 55 674663 17729 89936000
Basal cell carcinoma 29.03 15.11 378 674340 33011 89920718
Peripheral ischaemia 28.77 15.11 4 674714 5663 89948066
Abnormal dreams 28.57 15.11 25 674693 11232 89942497
Cardiac tamponade 28.53 15.11 4 674714 5628 89948101
Rhinovirus infection 28.48 15.11 5 674713 5958 89947771
Crepitations 28.44 15.11 136 674582 8716 89945013
Spondylitis 28.43 15.11 192 674526 13986 89939743
Therapeutic response decreased 28.41 15.11 872 673846 88857 89864872
Hip fracture 28.35 15.11 138 674580 32939 89920790
Injection site discomfort 28.33 15.11 5 674713 5935 89947794
Humerus fracture 28.32 15.11 19 674699 9766 89943963
Limb operation 28.27 15.11 86 674632 4441 89949288
Endometriosis 28.23 15.11 6 674712 6242 89947487
Blood uric acid increased 28.19 15.11 11 674707 7693 89946036
Injection site reaction 28.14 15.11 891 673827 91189 89862540
Somnambulism 28.10 15.11 6 674712 6222 89947507
Scleritis 28.02 15.11 94 674624 5114 89948615
Hair growth abnormal 27.98 15.11 75 674643 3601 89950128
Proctalgia 27.93 15.11 13 674705 8185 89945544
Dry eye 27.77 15.11 595 674123 57336 89896393
Feeling hot 27.68 15.11 411 674307 77597 89876132
Bradyphrenia 27.64 15.11 11 674707 7601 89946128
Dysphoria 27.62 15.11 6 674712 6148 89947581
Rash papular 27.48 15.11 70 674648 20285 89933444
Retching 27.35 15.11 64 674654 19095 89934634
Skin abrasion 27.27 15.11 26 674692 11209 89942520
Invasive ductal breast carcinoma 27.26 15.11 12 674706 7806 89945923
Synovial fluid analysis 27.26 15.11 63 674655 2755 89950974
Blood glucose fluctuation 27.24 15.11 3 674715 5080 89948649
Limb discomfort 27.11 15.11 416 674302 37644 89916085
Tension headache 27.02 15.11 11 674707 7498 89946231
Clostridium test positive 26.98 15.11 4 674714 5397 89948332
Femoral neck fracture 26.86 15.11 22 674696 10211 89943518
Spinal fusion surgery 26.86 15.11 170 674548 12113 89941616
Enterococcal infection 26.83 15.11 21 674697 9970 89943759
Aortic stenosis 26.82 15.11 7 674711 6329 89947400
Shoulder operation 26.76 15.11 64 674654 2862 89950867
Cholangitis 26.71 15.11 10 674708 7172 89946557
Potentiating drug interaction 26.50 15.11 5 674713 5657 89948072
Product physical issue 26.48 15.11 5 674713 5655 89948074
Angina unstable 26.47 15.11 10 674708 7133 89946596
Incorrect product administration duration 26.43 15.11 66 674652 19256 89934473
Systemic inflammatory response syndrome 26.09 15.11 8 674710 6508 89947221
Coronary artery stenosis 26.08 15.11 4 674714 5262 89948467
Dermatitis exfoliative generalised 26.04 15.11 5 674713 5588 89948141
Anaphylactic reaction 25.84 15.11 477 674241 87047 89866682
Iron deficiency anaemia 25.72 15.11 90 674628 23572 89930157
Venous thrombosis 25.68 15.11 5 674713 5532 89948197
Enthesopathy 25.66 15.11 138 674580 9266 89944463
Rheumatoid factor negative 25.64 15.11 27 674691 584 89953145
Vitamin D deficiency 25.58 15.11 58 674660 17498 89936231
Vasculitis 25.56 15.11 85 674633 22608 89931121
Abdominal distension 25.36 15.11 759 673959 129842 89823887
Neutrophilia 25.20 15.11 6 674712 5772 89947957
Pneumonia bacterial 25.19 15.11 35 674683 12755 89940974
Ageusia 25.18 15.11 51 674667 16025 89937704
Retinal haemorrhage 25.11 15.11 6 674712 5758 89947971
Breast cancer stage II 25.09 15.11 386 674332 34948 89918781
Maternal exposure timing unspecified 25.07 15.11 267 674451 22216 89931513
Skin swelling 24.95 15.11 9 674709 6605 89947124
Bacterial infection 24.93 15.11 90 674628 23354 89930375
Escherichia bacteraemia 24.92 15.11 6 674712 5729 89948000
Injection site irritation 24.79 15.11 7 674711 6008 89947721
Meningioma 24.78 15.11 4 674714 5067 89948662
Choking 24.65 15.11 32 674686 12001 89941728
Decubitus ulcer 24.62 15.11 31 674687 11782 89941947
Ulcer haemorrhage 24.59 15.11 302 674416 26019 89927710
Post procedural complication 24.55 15.11 67 674651 18975 89934754
Protein total decreased 24.53 15.11 11 674707 7078 89946651
Pathogen resistance 24.52 15.11 15 674703 8100 89945629
Pain of skin 24.37 15.11 52 674666 16030 89937699
Coronary artery occlusion 24.23 15.11 17 674701 8537 89945192
Investigation abnormal 24.21 15.11 53 674665 2234 89951495
Clostridial infection 24.19 15.11 3 674715 4633 89949096
Pneumonia fungal 24.19 15.11 11 674707 7020 89946709
Loose body in joint 24.18 15.11 40 674678 1362 89952367
Incoherent 24.15 15.11 4 674714 4973 89948756
Affective disorder 24.12 15.11 14 674704 7779 89945950
Paronychia 23.91 15.11 15 674703 7991 89945738
Dysaesthesia 23.84 15.11 5 674713 5250 89948479
Dyslipidaemia 23.82 15.11 24 674694 10083 89943646
Gastric ulcer 23.82 15.11 114 674604 27334 89926395
Blood creatine increased 23.81 15.11 11 674707 6956 89946773
Bone swelling 23.79 15.11 45 674673 1706 89952023
Apnoea 23.78 15.11 21 674697 9393 89944336
Infiltration anaesthesia 23.70 15.11 16 674702 181 89953548
Macular oedema 23.70 15.11 4 674714 4905 89948824
Bacterial test positive 23.67 15.11 6 674712 5533 89948196
Respiration abnormal 23.67 15.11 15 674703 7948 89945781
Wound dehiscence 23.58 15.11 7 674711 5815 89947914
Rhinorrhoea 23.53 15.11 841 673877 87475 89866254
Intestinal perforation 23.53 15.11 42 674676 13839 89939890
Tumour marker increased 23.49 15.11 7 674711 5800 89947929
Paradoxical drug reaction 23.23 15.11 7 674711 5759 89947970
Anaphylactoid reaction 23.05 15.11 3 674715 4465 89949264
Sleep terror 23.02 15.11 3 674715 4461 89949268
Injury associated with device 23.02 15.11 3 674715 4461 89949268
Oesophageal candidiasis 23.00 15.11 11 674707 6818 89946911
Blood glucose abnormal 23.00 15.11 22 674696 9470 89944259
Device related sepsis 22.93 15.11 4 674714 4789 89948940
Nervous system disorder 22.89 15.11 83 674635 21510 89932219
Euphoric mood 22.85 15.11 6 674712 5403 89948326
Back pain 22.71 15.11 2042 672676 315133 89638596
Feeling drunk 22.70 15.11 4 674714 4754 89948975
Uterine haemorrhage 22.66 15.11 4 674714 4748 89948981
Fibrosis 22.62 15.11 8 674710 5944 89947785
Fine motor skill dysfunction 22.56 15.11 90 674628 5329 89948400
Immobile 22.55 15.11 101 674617 6297 89947432
Non-small cell lung cancer 22.46 15.11 3 674715 4378 89949351
Lung neoplasm 22.46 15.11 11 674707 6724 89947005
Blood phosphorus decreased 22.41 15.11 5 674713 5029 89948700
Neuralgia 22.30 15.11 140 674578 31360 89922369
Nail operation 22.29 15.11 46 674672 1860 89951869
Hepatic cirrhosis 22.29 15.11 623 674095 62630 89891099
Colitis ischaemic 22.17 15.11 36 674682 12310 89941419
Spinal osteoarthritis 22.07 15.11 71 674647 19077 89934652
Transplant dysfunction 22.04 15.11 6 674712 5276 89948453
Ocular hyperaemia 22.02 15.11 154 674564 33644 89920085
Epidural lipomatosis 21.93 15.11 17 674701 242 89953487
Supraventricular extrasystoles 21.89 15.11 6 674712 5251 89948478
Cerebral haematoma 21.84 15.11 3 674715 4286 89949443
Nephropathy 21.69 15.11 22 674696 9213 89944516
Granulomatous rosacea 21.67 15.11 8 674710 19 89953710
Spinal cord compression 21.62 15.11 5 674713 4906 89948823
Hypertensive cardiomyopathy 21.59 15.11 18 674700 286 89953443
Musculoskeletal chest pain 21.58 15.11 97 674621 23653 89930076
Pathological fracture 21.58 15.11 24 674694 9636 89944093
Mucous stools 21.51 15.11 87 674631 5184 89948545
Hepatic cyst 21.49 15.11 11 674707 6557 89947172
Mass 21.47 15.11 53 674665 15524 89938205
Spinal compression fracture 21.43 15.11 51 674667 15127 89938602
Iron deficiency 21.34 15.11 24 674694 9588 89944141
Gastrointestinal toxicity 21.31 15.11 132 674586 9335 89944394
Injection site vesicles 21.24 15.11 3 674715 4197 89949532
Subcutaneous drug absorption impaired 21.22 15.11 173 674545 13372 89940357
Uterine leiomyoma 21.13 15.11 30 674688 10834 89942895
Fluid retention 21.02 15.11 497 674221 87594 89866135
C-reactive protein decreased 21.02 15.11 33 674685 1074 89952655
Blood pressure inadequately controlled 21.00 15.11 10 674708 6214 89947515
Metastatic neoplasm 21.00 15.11 5 674713 4810 89948919
Metastases to peritoneum 20.93 15.11 3 674715 4152 89949577
Hepatic lesion 20.93 15.11 8 674710 5665 89948064
Ankle operation 20.90 15.11 39 674679 1463 89952266
Dyspnoea at rest 20.85 15.11 5 674713 4786 89948943
Product label confusion 20.84 15.11 261 674457 22589 89931140
Neutrophil count abnormal 20.75 15.11 3 674715 4125 89949604
Toothache 20.74 15.11 255 674463 21975 89931754
Diverticulitis 20.67 15.11 461 674257 44726 89909003
Scratch 20.45 15.11 26 674692 9840 89943889
Gastric ulcer haemorrhage 20.42 15.11 7 674711 5304 89948425
Antibiotic therapy 20.41 15.11 35 674683 1228 89952501
Rash pustular 20.28 15.11 18 674700 8031 89945698
Nocturia 20.26 15.11 28 674690 10227 89943502
Large intestine polyp 20.23 15.11 24 674694 9362 89944367
Back injury 20.19 15.11 472 674246 46150 89907579
Hypertransaminasaemia 20.17 15.11 56 674662 15769 89937960
Discontinued product administered 20.16 15.11 12 674706 107 89953622
Dysmenorrhoea 20.09 15.11 5 674713 4667 89949062
Tenosynovitis stenosans 20.09 15.11 70 674648 3883 89949846
Hepatic enzyme abnormal 20.08 15.11 111 674607 7531 89946198
Haemorrhagic diathesis 20.03 15.11 8 674710 5516 89948213
Blood urine present 19.96 15.11 64 674654 17214 89936515
Neck mass 19.95 15.11 69 674649 3813 89949916
Injection site discolouration 19.91 15.11 24 674694 9296 89944433
Breast cancer recurrent 19.90 15.11 8 674710 5495 89948234
Bradykinesia 19.89 15.11 13 674705 6775 89946954
Diffuse large B-cell lymphoma 19.84 15.11 21 674697 8624 89945105
Bunion operation 19.83 15.11 36 674682 1322 89952407
Meningitis aseptic 19.80 15.11 13 674705 6760 89946969
Anxiety disorder 19.79 15.11 6 674712 4916 89948813
Conjunctival haemorrhage 19.79 15.11 3 674715 3981 89949748
Dental caries 19.76 15.11 34 674684 11363 89942366
Mood swings 19.76 15.11 83 674635 20619 89933110
Blepharitis 19.73 15.11 3 674715 3973 89949756
Gastritis erosive 19.70 15.11 13 674705 6742 89946987
White blood cells urine positive 19.65 15.11 12 674706 6486 89947243
Facial paresis 19.65 15.11 3 674715 3960 89949769
Haemorrhagic stroke 19.64 15.11 12 674706 6484 89947245
Enteritis 19.58 15.11 29 674689 10292 89943437
Kidney infection 19.52 15.11 286 674432 25630 89928099
Anaemia macrocytic 19.45 15.11 5 674713 4567 89949162
Extrasystoles 19.23 15.11 9 674709 5648 89948081
Trismus 19.16 15.11 6 674712 4815 89948914
Autoimmune haemolytic anaemia 19.16 15.11 9 674709 5636 89948093
Menstruation irregular 19.16 15.11 19 674699 8041 89945688
Gallbladder disorder 19.15 15.11 79 674639 19724 89934005
Joint lock 19.10 15.11 52 674666 2520 89951209
Platelet count increased 19.07 15.11 85 674633 20774 89932955
Pseudomembranous colitis 19.01 15.11 3 674715 3865 89949864
Renal disorder 18.97 15.11 185 674533 37674 89916055
Duodenal ulcer 18.95 15.11 26 674692 9526 89944203
Throat clearing 18.87 15.11 3 674715 3844 89949885
Initial insomnia 18.82 15.11 25 674693 9285 89944444
Shoulder arthroplasty 18.82 15.11 71 674647 4095 89949634
Musculoskeletal discomfort 18.82 15.11 239 674479 20752 89932977
Wound complication 18.80 15.11 6 674712 4757 89948972
Lymphoedema 18.80 15.11 47 674671 13706 89940023
Post-traumatic stress disorder 18.78 15.11 14 674704 6814 89946915
Gastrointestinal motility disorder 18.77 15.11 11 674707 6080 89947649
Jaw disorder 18.66 15.11 9 674709 5550 89948179
Retinal toxicity 18.65 15.11 36 674682 1386 89952343
Escherichia sepsis 18.65 15.11 10 674708 5806 89947923
Gastrooesophageal reflux disease 18.64 15.11 1030 673688 165307 89788422
Depressive symptom 18.60 15.11 8 674710 5277 89948452
Optic neuritis 18.55 15.11 27 674691 9651 89944078
Panic reaction 18.52 15.11 6 674712 4711 89949018
Impaired quality of life 18.45 15.11 99 674619 23045 89930684
Portal hypertension 18.42 15.11 6 674712 4695 89949034
Skin warm 18.41 15.11 18 674700 7669 89946060
Lumbar vertebral fracture 18.40 15.11 17 674701 7441 89946288
Anosmia 18.37 15.11 28 674690 9820 89943909
Gastroenteritis viral 18.36 15.11 323 674395 30032 89923697
Urinary tract infection 18.36 15.11 1993 672725 303639 89650090
Bursitis infective 18.32 15.11 37 674681 1473 89952256
Catheterisation cardiac 18.26 15.11 7 674711 4949 89948780
Screaming 18.23 15.11 3 674715 3747 89949982
Thoracic vertebral fracture 18.16 15.11 9 674709 5465 89948264
Biliary colic 18.16 15.11 4 674714 4059 89949670
Nerve block 18.14 15.11 27 674691 838 89952891
Bruxism 18.13 15.11 5 674713 4358 89949371
Erythema nodosum 18.12 15.11 10 674708 5714 89948015
Hepatitis toxic 18.06 15.11 3 674715 3722 89950007
Blood folate decreased 18.02 15.11 39 674679 1631 89952098
Staphylococcus test positive 18.01 15.11 5 674713 4340 89949389
Behaviour disorder 18.01 15.11 6 674712 4629 89949100
Cervical dysplasia 17.97 15.11 4 674714 4030 89949699
Diabetic eye disease 17.88 15.11 13 674705 167 89953562
Decreased immune responsiveness 17.86 15.11 119 674599 8629 89945100
Overwork 17.79 15.11 9 674709 56 89953673
Mean cell haemoglobin concentration abnormal 17.76 15.11 12 674706 136 89953593
Anal fistula 17.74 15.11 5 674713 4296 89949433
Vitreous floaters 17.71 15.11 18 674700 7531 89946198
Diverticulum 17.67 15.11 40 674678 12073 89941656
Oxygen saturation abnormal 17.66 15.11 5 674713 4283 89949446
Vasculitic rash 17.65 15.11 35 674683 1375 89952354
Iridocyclitis 17.64 15.11 3 674715 3658 89950071
Neurological symptom 17.63 15.11 15 674703 6832 89946897
Oesophageal ulcer 17.62 15.11 8 674710 5111 89948618
Ocular icterus 17.62 15.11 4 674714 3976 89949753
Immunodeficiency 17.60 15.11 434 674284 42800 89910929
Areflexia 17.58 15.11 3 674715 3650 89950079
White blood cell count abnormal 17.48 15.11 18 674700 7486 89946243
Ear pruritus 17.40 15.11 15 674703 6788 89946941
Inability to afford medication 17.38 15.11 3 674715 3619 89950110
Choking sensation 17.38 15.11 4 674714 3938 89949791
Aortic valve stenosis 17.35 15.11 5 674713 4235 89949494
Breast cancer stage I 17.34 15.11 28 674690 9596 89944133
Facial pain 17.29 15.11 46 674672 13136 89940593
Obstruction 17.24 15.11 4 674714 3917 89949812
Cardiac dysfunction 17.21 15.11 3 674715 3594 89950135
Therapy change 17.18 15.11 22 674696 8300 89945429
Tongue disorder 17.17 15.11 139 674579 10721 89943008
Phlebitis 17.11 15.11 18 674700 7412 89946317
Parathyroid disorder 17.03 15.11 25 674693 766 89952963
Cardiopulmonary failure 17.03 15.11 5 674713 4183 89949546
Autoimmune hepatitis 16.94 15.11 32 674686 10319 89943410
Hip surgery 16.93 15.11 69 674649 4126 89949603
Cystitis 16.88 15.11 373 674345 66345 89887384
Acute febrile neutrophilic dermatosis 16.87 15.11 3 674715 3542 89950187
Fluid intake reduced 16.80 15.11 5 674713 4147 89949582
Palindromic rheumatism 16.77 15.11 13 674705 185 89953544
Hyperaesthesia 16.72 15.11 34 674684 10668 89943061
Laryngeal pain 16.71 15.11 6 674712 4416 89949313
Blood disorder 16.70 15.11 20 674698 7770 89945959
Urine analysis abnormal 16.70 15.11 9 674709 5212 89948517
Bone lesion 16.70 15.11 14 674704 6423 89947306
Bacterial sepsis 16.66 15.11 8 674710 4947 89948782
COVID-19 pneumonia 16.66 15.11 74 674644 18103 89935626
Microcytic anaemia 16.58 15.11 4 674714 3814 89949915
Device defective 16.48 15.11 3 674715 3483 89950246
Urine abnormality 16.45 15.11 20 674698 7717 89946012
Intestinal sepsis 16.44 15.11 16 674702 314 89953415
Physical deconditioning 16.41 15.11 45 674673 2190 89951539
Duodenitis 16.35 15.11 6 674712 4357 89949372
Skin papilloma 16.31 15.11 84 674634 5546 89948183
Latent tuberculosis 16.26 15.11 54 674664 2922 89950807
Procedural complication 16.24 15.11 12 674706 5866 89947863
Papilloedema 16.22 15.11 7 674711 4608 89949121
Abdominal abscess 16.22 15.11 10 674708 5377 89948352
Blood parathyroid hormone increased 16.16 15.11 3 674715 3434 89950295
Pneumatosis intestinalis 16.16 15.11 3 674715 3434 89950295
Metastases to spine 16.10 15.11 4 674714 3739 89949990
Thrombocytosis 16.08 15.11 17 674701 6984 89946745
Subdural haemorrhage 16.07 15.11 3 674715 3420 89950309
Multiple system atrophy 16.04 15.11 13 674705 198 89953531
Occult blood positive 16.00 15.11 5 674713 4018 89949711
Pulmonary tuberculosis 15.96 15.11 8 674710 4826 89948903
Lip squamous cell carcinoma 15.95 15.11 12 674706 163 89953566
Skin ulcer 15.95 15.11 487 674231 49588 89904141
Meningitis 15.93 15.11 24 674694 8457 89945272
Blood creatinine decreased 15.90 15.11 15 674703 6500 89947229
Ear injury 15.88 15.11 16 674702 328 89953401
Bone density abnormal 15.85 15.11 67 674651 4073 89949656
Haemarthrosis 15.82 15.11 5 674713 3989 89949740
Blindness transient 15.80 15.11 7 674711 4536 89949193
Foot fracture 15.70 15.11 282 674436 26324 89927405
Pharyngitis 15.67 15.11 240 674478 21707 89932022
Salt craving 15.62 15.11 11 674707 134 89953595
Photopsia 15.58 15.11 9 674709 5015 89948714
Peroneal nerve palsy 15.54 15.11 12 674706 5736 89947993
Gallbladder adenocarcinoma 15.52 15.11 10 674708 104 89953625
Blood pressure diastolic increased 15.48 15.11 47 674671 12859 89940870
Laryngospasm 15.48 15.11 3 674715 3330 89950399
Skin tightness 15.47 15.11 7 674711 4481 89949248
Blood prolactin increased 15.43 15.11 4 674714 3633 89950096
Bronchiectasis 15.42 15.11 100 674618 22230 89931499
Blindness unilateral 15.41 15.11 21 674697 7715 89946014
Crying 15.20 15.11 120 674598 25525 89928204
Myasthenia gravis 15.20 15.11 17 674701 6808 89946921
Colorectal cancer 15.20 15.11 5 674713 3888 89949841
Erythema of eyelid 15.15 15.11 3 674715 3280 89950449

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 3337.07 18.84 4918 75613 625279 41915525
Joint swelling 1494.14 18.84 1145 79386 66877 42473927
Condition aggravated 1421.35 18.84 2078 78453 258676 42282128
Arthralgia 1363.46 18.84 1800 78731 203438 42337366
Therapeutic product effect incomplete 1325.77 18.84 1086 79445 69853 42470951
Product dose omission in error 1207.08 18.84 489 80042 7865 42532939
Musculoskeletal stiffness 1109.68 18.84 899 79632 56866 42483938
Pain 1100.17 18.84 1786 78745 243062 42297742
Rheumatoid arthritis 888.42 18.84 695 79836 41745 42499059
Therapeutic product effect decreased 765.45 18.84 616 79915 38534 42502270
Product dose omission issue 678.83 18.84 1117 79414 153248 42387556
Treatment failure 627.62 18.84 679 79852 61945 42478859
Synovitis 586.87 18.84 366 80165 15201 42525603
Drug intolerance 563.44 18.84 726 79805 79698 42461106
Frequent bowel movements 521.43 18.84 384 80147 21023 42519781
Arthropathy 518.29 18.84 437 80094 29160 42511644
Discouragement 501.77 18.84 129 80402 389 42540415
Contraindicated product administered 494.46 18.84 398 80133 24874 42515930
Herpes zoster 456.44 18.84 459 80072 38418 42502386
Pain in extremity 433.71 18.84 909 79622 149695 42391109
Acute kidney injury 426.62 18.84 88 80443 367249 42173555
Peripheral swelling 420.18 18.84 671 79860 89599 42451205
Sensitivity to weather change 377.52 18.84 143 80388 1900 42538904
Hypotension 355.70 18.84 37 80494 257594 42283210
Toxicity to various agents 343.48 18.84 23 80508 229113 42311691
Loss of personal independence in daily activities 342.74 18.84 446 80085 49370 42491434
C-reactive protein abnormal 334.57 18.84 212 80319 9049 42531755
Arthritis 329.75 18.84 402 80129 41663 42499141
Febrile neutropenia 321.21 18.84 6 80525 185697 42355107
COVID-19 318.62 18.84 687 79844 115261 42425543
Drug hypersensitivity 317.92 18.84 627 79904 98762 42442042
Bone erosion 312.67 18.84 157 80374 4246 42536558
Haematochezia 311.90 18.84 463 80068 57973 42482831
Red blood cell sedimentation rate abnormal 305.81 18.84 148 80383 3688 42537116
Illness 302.93 18.84 300 80231 24630 42516174
Drug interaction 291.53 18.84 73 80458 266926 42273878
Red blood cell sedimentation rate increased 282.93 18.84 196 80335 9728 42531076
Abdominal discomfort 279.32 18.84 506 80025 74749 42466055
Joint range of motion decreased 259.09 18.84 169 80362 7584 42533220
Neutropenia 245.57 18.84 41 80490 199390 42341414
Joint stiffness 238.66 18.84 193 80338 12129 42528675
Thrombocytopenia 225.83 18.84 43 80488 190236 42350568
Headache 223.30 18.84 969 79562 238400 42302404
Vomiting 217.55 18.84 140 80391 289583 42251221
Therapeutic response unexpected 209.36 18.84 173 80358 11208 42529596
Swelling 207.33 18.84 372 80159 54513 42486291
Disability 204.81 18.84 132 80399 5801 42535003
Blood cholesterol increased 192.56 18.84 245 80286 26496 42514308
Rheumatoid factor negative 191.05 18.84 72 80459 942 42539862
Malignant neoplasm progression 185.32 18.84 4 80527 108396 42432408
Anaemia 181.34 18.84 158 80373 280120 42260684
Drug effective for unapproved indication 179.73 18.84 127 80404 6506 42534298
Nasopharyngitis 179.27 18.84 451 80080 83545 42457259
Drug abuse 178.59 18.84 4 80527 104767 42436037
Acne 167.20 18.84 165 80366 13479 42527325
Knee arthroplasty 166.79 18.84 136 80395 8645 42532159
Chondropathy 161.09 18.84 67 80464 1153 42539651
Mobility decreased 160.63 18.84 260 80271 35046 42505758
Intentional dose omission 159.89 18.84 134 80397 8852 42531952
Completed suicide 159.48 18.84 5 80526 96460 42444344
Gastric disorder 157.02 18.84 150 80381 11772 42529032
C-reactive protein increased 154.57 18.84 359 80172 63201 42477603
Impaired work ability 153.35 18.84 149 80382 11942 42528862
Inflammation 148.22 18.84 245 80286 33602 42507202
Hand deformity 148.03 18.84 91 80440 3677 42537127
Spinal instability 147 18.84 52 80479 561 42540243
Memory impairment 146.28 18.84 305 80226 49917 42490887
Dehydration 144.70 18.84 44 80487 141723 42399081
Death 144.32 18.84 436 80095 470749 42070055
Osteoarthritis 138.24 18.84 199 80332 24206 42516598
Joint lock 136.88 18.84 62 80469 1323 42539481
Multiple organ dysfunction syndrome 136.12 18.84 13 80518 97022 42443782
Seizure 135.21 18.84 31 80500 120530 42420274
Hyperkalaemia 133.61 18.84 4 80527 80454 42460350
Hip arthroplasty 133.24 18.84 97 80434 5208 42535596
Rhabdomyolysis 132.86 18.84 3 80528 78016 42462788
Drug tolerance decreased 132.77 18.84 72 80459 2288 42538516
Disease progression 130.53 18.84 54 80477 143602 42397202
Dyspnoea 129.52 18.84 418 80113 442203 42098601
Bowel movement irregularity 128.67 18.84 81 80450 3415 42537389
Tachycardia 128.33 18.84 19 80512 101068 42439736
Atlantoaxial instability 127.42 18.84 43 80488 398 42540406
Steroid dependence 125.34 18.84 103 80428 6619 42534185
Bradycardia 121.11 18.84 11 80520 85473 42455331
Off label use 120.60 18.84 1779 78752 636556 41904248
Onychoclasis 119.62 18.84 70 80461 2582 42538222
General physical health deterioration 119.01 18.84 69 80462 151177 42389627
Cardiac arrest 118.87 18.84 30 80501 109290 42431514
Pancytopenia 115.77 18.84 39 80492 117704 42423100
Respiratory failure 115.05 18.84 49 80482 128083 42412721
Liver function test increased 114.63 18.84 164 80367 19834 42520970
Acne cystic 112.10 18.84 42 80489 540 42540264
Decreased appetite 111.83 18.84 120 80411 193017 42347787
Overdose 110.45 18.84 31 80500 105233 42435571
Apparent death 109.84 18.84 75 80456 3633 42537171
Syncope 106.69 18.84 28 80503 99378 42441426
Pyrexia 106.43 18.84 385 80146 393657 42147147
Septic shock 105.96 18.84 22 80509 91650 42449154
Hypokalaemia 104.98 18.84 8 80523 71713 42469091
Agitation 103.95 18.84 4 80527 64310 42476494
Platelet count decreased 102.40 18.84 68 80463 138513 42402291
Rectal haemorrhage 100.20 18.84 261 80270 49345 42491459
Diverticulitis 99.90 18.84 165 80366 22608 42518196
Lymphoma 99.60 18.84 129 80402 14192 42526612
Cardio-respiratory arrest 97.04 18.84 3 80528 58633 42482171
Dislocation of vertebra 96.66 18.84 35 80496 406 42540398
Hypoxia 96.16 18.84 10 80521 69776 42471028
Musculoskeletal pain 95.33 18.84 201 80330 33139 42507665
Mineral metabolism disorder 95.28 18.84 34 80497 377 42540427
Mycobacterium tuberculosis complex test positive 95.24 18.84 50 80481 1486 42539318
Neutrophil count decreased 93.02 18.84 7 80524 63408 42477396
Anti-cyclic citrullinated peptide antibody positive 92.98 18.84 53 80478 1859 42538945
Spinal operation 92.24 18.84 71 80460 4149 42536655
Ascites 90.01 18.84 4 80527 56674 42484130
Sarcoidosis 89.47 18.84 66 80465 3616 42537188
Therapy interrupted 89.36 18.84 155 80376 22095 42518709
Terminal state 87.16 18.84 70 80461 4353 42536451
Gastrointestinal haemorrhage 86.71 18.84 38 80493 97688 42443116
Tooth loss 86.69 18.84 68 80463 4086 42536718
Hypoglycaemia 86.69 18.84 7 80524 59847 42480957
Tuberculin test positive 86.56 18.84 43 80488 1135 42539669
Physical disability 85.96 18.84 50 80481 1823 42538981
Confusional state 85.43 18.84 115 80416 167482 42373322
Hallucination 85.34 18.84 6 80525 57501 42483303
Pulmonary thrombosis 84.29 18.84 91 80440 8257 42532547
Sleep disorder due to general medical condition, insomnia type 83.15 18.84 45 80486 1424 42539380
Limb discomfort 82.60 18.84 111 80420 12656 42528148
Polyarthritis 82.41 18.84 72 80459 5032 42535772
Blood creatinine increased 81.21 18.84 54 80477 109949 42430855
Haematuria 80.36 18.84 8 80523 57791 42483013
Loss of consciousness 78.69 18.84 38 80493 92316 42448488
Intestinal sepsis 78.62 18.84 35 80496 716 42540088
Catarrh 78.22 18.84 75 80456 5911 42534893
Asthenia 77.91 18.84 271 80260 280522 42260282
Cytology abnormal 77.82 18.84 29 80502 367 42540437
Colitis ulcerative 77.39 18.84 160 80371 26015 42514789
Burns second degree 77.06 18.84 75 80456 6021 42534783
Lipids increased 76.71 18.84 40 80491 1172 42539632
Fall 76.64 18.84 210 80321 234310 42306494
Neoplasm malignant 75.61 18.84 146 80385 22597 42518207
Knee operation 75.47 18.84 52 80479 2556 42538248
Rheumatoid factor positive 75.43 18.84 35 80496 791 42540013
Foetal exposure during pregnancy 73.01 18.84 4 80527 47307 42493497
Coma 72.94 18.84 8 80523 53546 42487258
Joint arthroplasty 72.79 18.84 36 80495 941 42539863
Alopecia 71.82 18.84 166 80365 29110 42511694
Defaecation urgency 71.81 18.84 58 80473 3636 42537168
Tooth fracture 71.57 18.84 61 80470 4123 42536681
Ill-defined disorder 71.37 18.84 118 80413 16178 42524626
Depressed level of consciousness 71.20 18.84 5 80526 47965 42492839
Cytokine release syndrome 71.17 18.84 3 80528 44524 42496280
Delirium 71.14 18.84 8 80523 52511 42488293
Nipple swelling 70.51 18.84 27 80504 370 42540434
Plasma cell myeloma 70.50 18.84 5 80526 47573 42493231
Systemic lupus erythematosus 69.59 18.84 87 80444 9237 42531567
Infusion related reaction 69.41 18.84 15 80516 60791 42480013
Dizziness 68.15 18.84 242 80289 249012 42291792
Rhinorrhoea 64.92 18.84 168 80363 31626 42509178
Gingival pain 64.59 18.84 80 80451 8414 42532390
Pneumonia aspiration 64.49 18.84 9 80522 50069 42490735
Oxygen saturation decreased 64.30 18.84 21 80510 64666 42476138
Parosmia 64.29 18.84 76 80455 7615 42533189
Sepsis 63.98 18.84 180 80351 199154 42341650
Drug ineffective for unapproved indication 63.60 18.84 212 80319 45951 42494853
Depressed mood 63.41 18.84 138 80393 23246 42517558
Cardiac failure congestive 63.20 18.84 42 80489 85560 42455244
Hypopnoea 62.79 18.84 76 80455 7806 42532998
Mass 62.77 18.84 80 80451 8659 42532145
Seronegative arthritis 62.41 18.84 35 80496 1189 42539615
Infection 61.99 18.84 393 80138 111675 42429129
Intervertebral disc space narrowing 61.83 18.84 34 80497 1111 42539693
Product use issue 61.80 18.84 298 80233 76453 42464351
Blood pressure decreased 61.49 18.84 17 80514 58315 42482489
Atrial fibrillation 60.37 18.84 107 80424 139486 42401318
Hyperglycaemia 59.63 18.84 8 80523 45851 42494953
Angioedema 58.73 18.84 6 80525 42471 42498333
Stress 58.23 18.84 200 80331 44012 42496792
Aspartate aminotransferase increased 58.13 18.84 37 80494 77126 42463678
Sinusitis 58.03 18.84 209 80322 47083 42493721
Short stature 57.54 18.84 24 80507 416 42540388
Gastrointestinal disorder 57.10 18.84 206 80325 46447 42494357
Injection site pain 57.03 18.84 19 80512 57779 42483025
Dysarthria 56.69 18.84 5 80526 39802 42501002
Pleural effusion 56.58 18.84 60 80471 97106 42443698
Oral surgery 56.01 18.84 26 80505 588 42540216
Osteosclerosis 55.73 18.84 35 80496 1469 42539335
Mental status changes 55.59 18.84 7 80524 42108 42498696
Myelosuppression 55.21 18.84 6 80525 40455 42500349
Cardiogenic shock 55.03 18.84 3 80528 35637 42505167
Cardiac failure 54.74 18.84 73 80458 106783 42434021
Photosensitivity reaction 54.31 18.84 91 80440 12611 42528193
Coronary artery disease 54.17 18.84 17 80514 53703 42487101
Migraine 53.65 18.84 136 80395 25278 42515526
Fibromyalgia 52.98 18.84 50 80481 3863 42536941
Mycobacterium chelonae infection 52.88 18.84 31 80500 1147 42539657
Faecal calprotectin increased 52.70 18.84 45 80486 3049 42537755
Skin laceration 52.66 18.84 95 80436 13963 42526841
Intentional product use issue 52.23 18.84 271 80260 71562 42469242
Impaired quality of life 52.08 18.84 95 80436 14082 42526722
Joint noise 51.99 18.84 29 80502 975 42539829
Dysphagia 51.92 18.84 37 80494 72682 42468122
Physical deconditioning 51.55 18.84 40 80491 2365 42538439
Hair growth abnormal 51.50 18.84 29 80502 993 42539811
Pre-existing condition improved 50.27 18.84 43 80488 2920 42537884
Hepatic enzyme increased 50.07 18.84 195 80336 45589 42495215
Cholestasis 50.05 18.84 3 80528 32876 42507928
Influenza 49.03 18.84 240 80291 61935 42478869
Nasal congestion 48.46 18.84 144 80387 29357 42511447
Respiratory distress 48.38 18.84 10 80521 41810 42498994
Epistaxis 47.71 18.84 34 80497 66792 42474012
Nipple pain 47.21 18.84 28 80503 1059 42539745
Joint effusion 47.20 18.84 57 80474 5840 42534964
Agranulocytosis 45.98 18.84 3 80528 30609 42510195
Orthostatic hypotension 45.91 18.84 3 80528 30567 42510237
Hepatic function abnormal 45.80 18.84 20 80511 51547 42489257
Inflammatory bowel disease 45.70 18.84 44 80487 3485 42537319
Suicidal ideation 45.51 18.84 17 80514 48144 42492660
Intentional product misuse 45.33 18.84 234 80297 61666 42479138
Dyspnoea exertional 45.26 18.84 19 80512 50129 42490675
Psoriasis 45.26 18.84 197 80334 48407 42492397
Hypocalcaemia 45.20 18.84 3 80528 30170 42510634
Ventricular tachycardia 45.17 18.84 3 80528 30157 42510647
Jaundice 45.05 18.84 6 80525 34583 42506221
Lymph node calcification 44.24 18.84 15 80516 141 42540663
Colectomy 44.07 18.84 36 80495 2293 42538511
Anaphylactic reaction 44.04 18.84 13 80518 42730 42498074
Rheumatoid factor increased 43.52 18.84 23 80508 693 42540111
Shock 43.31 18.84 3 80528 29118 42511686
Loss of therapeutic response 42.78 18.84 28 80503 1263 42539541
Deep vein thrombosis 41.98 18.84 269 80262 76688 42464116
Cerebral haemorrhage 41.74 18.84 11 80520 38955 42501849
Pneumonia 41.71 18.84 555 79976 421594 42119210
Spinal cord injury cervical 41.60 18.84 17 80514 279 42540525
Disorientation 41.48 18.84 9 80522 36380 42504424
Neck pain 41.48 18.84 138 80393 29876 42510928
Blood glucose increased 41.26 18.84 47 80484 73652 42467152
Hospitalisation 40.96 18.84 48 80483 74282 42466522
Haemoptysis 40.85 18.84 18 80513 46149 42494655
Hypothyroidism 40.76 18.84 6 80525 32078 42508726
Prerenal failure 40.65 18.84 35 80496 2398 42538406
Oedema peripheral 40.64 18.84 127 80404 135949 42404855
Bone marrow failure 40.22 18.84 7 80524 33086 42507718
Upper gastrointestinal haemorrhage 40.08 18.84 5 80526 30294 42510510
Rhinitis 39.94 18.84 77 80454 11900 42528904
Localised infection 39.89 18.84 106 80425 20267 42520537
Skin mass 39.28 18.84 47 80484 4769 42536035
Hepatic cytolysis 39.25 18.84 3 80528 26841 42513963
Renal failure 38.91 18.84 140 80391 143586 42397218
Drug effect less than expected 38.86 18.84 42 80489 3815 42536989
Cardiac murmur 38.82 18.84 79 80452 12696 42528108
Bone cyst 38.78 18.84 29 80502 1622 42539182
Tenderness 38.46 18.84 64 80467 8819 42531985
Generalised tonic-clonic seizure 38.43 18.84 3 80528 26376 42514428
Drug level increased 38.11 18.84 3 80528 26197 42514607
Urinary retention 38.08 18.84 16 80515 42198 42498606
Fear of injection 37.98 18.84 31 80500 1972 42538832
Upper respiratory tract infection 37.79 18.84 169 80362 42004 42498800
Tooth extraction 37.53 18.84 49 80482 5431 42535373
Psoriatic arthropathy 37.39 18.84 118 80413 24849 42515955
Fine motor skill dysfunction 36.99 18.84 32 80499 2207 42538597
Blood alkaline phosphatase increased 36.92 18.84 9 80522 33588 42507216
Hepatic failure 36.76 18.84 13 80518 38087 42502717
Immune system disorder 36.75 18.84 51 80480 5993 42534811
Mucosal inflammation 36.74 18.84 24 80507 49350 42491454
Dyskinesia 36.67 18.84 3 80528 25387 42515417
Bronchiectasis 36.56 18.84 95 80436 17924 42522880
Nausea 36.21 18.84 530 80001 396269 42144535
Joint ankylosis 36.18 18.84 28 80503 1649 42539155
Skin cancer 36.17 18.84 72 80459 11390 42529414
Melaena 36.07 18.84 14 80517 38732 42502072
Restlessness 35.96 18.84 6 80525 29243 42511561
Somnolence 35.25 18.84 142 80389 140963 42399841
Chills 34.74 18.84 79 80452 93987 42446817
Alcohol poisoning 34.73 18.84 56 80475 7518 42533286
Hypomagnesaemia 34.68 18.84 6 80525 28482 42512322
Leukocytosis 34.57 18.84 7 80524 29701 42511103
Grip strength decreased 34.29 18.84 38 80493 3550 42537254
Pneumonitis 34.26 18.84 18 80513 41700 42499104
Blood urea increased 33.74 18.84 10 80521 32783 42508021
Hepatocellular injury 33.64 18.84 3 80528 23675 42517129
Mucous stools 33.52 18.84 32 80499 2508 42538296
Malaise 33.49 18.84 575 79956 211581 42329223
Flushing 33.46 18.84 14 80517 37014 42503790
Back pain 33.37 18.84 412 80119 141364 42399440
Feeling abnormal 33.30 18.84 236 80295 69550 42471254
Renal impairment 32.82 18.84 103 80428 110125 42430679
Incorrect dose administered 32.79 18.84 31 80500 52943 42487861
Heart rate decreased 32.71 18.84 14 80517 36518 42504286
Finger deformity 32.48 18.84 26 80505 1609 42539195
Hypoacusis 32.35 18.84 93 80438 18609 42522195
Arrhythmia 32.23 18.84 18 80513 40299 42500505
Alanine aminotransferase increased 32.04 18.84 75 80456 88331 42452473
Therapeutic product effect delayed 31.90 18.84 25 80506 1500 42539304
Aphasia 31.79 18.84 4 80527 24079 42516725
Tumour lysis syndrome 31.10 18.84 3 80528 22228 42518576
Circulatory collapse 31.02 18.84 4 80527 23632 42517172
Carbon dioxide abnormal 30.89 18.84 14 80517 299 42540505
Hernia 30.76 18.84 66 80465 11007 42529797
Musculoskeletal disorder 30.32 18.84 49 80482 6589 42534215
White blood cell count decreased 30.23 18.84 107 80424 110289 42430515
Acute respiratory failure 30.14 18.84 18 80513 38840 42501964
Dyspepsia 30.04 18.84 156 80375 41196 42499608
Cataract 29.99 18.84 126 80405 30478 42510326
Polyp 29.66 18.84 40 80491 4574 42536230
Blood iron decreased 29.36 18.84 47 80484 6271 42534533
Hepatic steatosis 29.08 18.84 98 80433 21350 42519454
Neuropathy peripheral 29.05 18.84 97 80434 101756 42439048
Diabetic ketoacidosis 28.84 18.84 4 80527 22363 42518441
Shoulder operation 28.53 18.84 23 80508 1438 42539366
Sinus disorder 28.38 18.84 53 80478 7997 42532807
Fatigue 28.32 18.84 1047 79484 434594 42106210
Pancreatitis acute 28.28 18.84 14 80517 33550 42507254
Abnormal faeces 28.18 18.84 36 80495 3905 42536899
Intestinal polyp 28.07 18.84 22 80509 1320 42539484
Urinary tract infection 28.01 18.84 95 80436 99189 42441615
Hip surgery 27.98 18.84 22 80509 1326 42539478
Arthrodesis 27.97 18.84 16 80515 565 42540239
Premature baby 27.91 18.84 5 80526 23148 42517656
Subdural haematoma 27.89 18.84 5 80526 23133 42517671
Pruritus 27.20 18.84 227 80304 188544 42352260
Blood bilirubin increased 27.01 18.84 24 80507 42228 42498576
Limb operation 26.82 18.84 19 80512 977 42539827
Leukopenia 26.61 18.84 64 80467 74682 42466122
Angiolymphoid hyperplasia with eosinophilia 26.59 18.84 10 80521 130 42540674
Wheezing 26.47 18.84 39 80492 54742 42486062
Hepatic enzyme abnormal 26.42 18.84 33 80498 3499 42537305
Arthritis bacterial 26.38 18.84 43 80488 5825 42534979
Hypophagia 26.34 18.84 9 80522 26947 42513857
Cerebral infarction 26.27 18.84 13 80518 31156 42509648
Coagulopathy 26.26 18.84 5 80526 22157 42518647
Trigger finger 25.88 18.84 19 80512 1033 42539771
Constipation 25.78 18.84 190 80341 162101 42378703
Pulmonary oedema 25.66 18.84 38 80493 53234 42487570
Therapy cessation 25.61 18.84 91 80440 20359 42520445
Oral disorder 25.44 18.84 38 80493 4774 42536030
Immobilisation syndrome 25.33 18.84 14 80517 462 42540342
Blood lactate dehydrogenase increased 24.99 18.84 9 80522 26072 42514732
Cognitive disorder 24.89 18.84 17 80514 34155 42506649
Polyneuropathy 24.87 18.84 3 80528 18658 42522146
Disseminated intravascular coagulation 24.72 18.84 8 80523 24786 42516018
Haematoma 24.67 18.84 11 80520 28012 42512792
Musculoskeletal discomfort 24.64 18.84 55 80476 9421 42531383
Eosinophilia 24.46 18.84 16 80515 32883 42507921
Tooth disorder 24.14 18.84 63 80468 11916 42528888
Rheumatoid factor 23.71 18.84 8 80523 74 42540730
Major depression 23.51 18.84 39 80492 5359 42535445
Urinary incontinence 23.43 18.84 6 80525 21662 42519142
Anxiety 23.33 18.84 130 80401 118430 42422374
Alanine aminotransferase abnormal 23.28 18.84 37 80494 4907 42535897
Oedema 23.24 18.84 39 80492 51962 42488842
Depression 22.99 18.84 316 80215 111047 42429757
Visual acuity reduced 22.96 18.84 3 80528 17547 42523257
Dry skin 22.78 18.84 35 80496 48303 42492501
Anaphylactic shock 22.73 18.84 8 80523 23509 42517295
Hemiparesis 22.66 18.84 3 80528 17373 42523431
Gamma-glutamyltransferase increased 22.58 18.84 17 80514 32480 42508324
Cryptitis 22.51 18.84 11 80520 280 42540524
Nodule 22.33 18.84 63 80468 12471 42528333
Intestinal intraepithelial lymphocytes increased 22.26 18.84 10 80521 209 42540595
Electrolyte imbalance 22.19 18.84 3 80528 17098 42523706
Acute myocardial infarction 22.16 18.84 48 80483 58117 42482687
Abdominal pain upper 22.05 18.84 246 80285 82363 42458441
Skin injury 21.91 18.84 26 80505 2615 42538189
Acute respiratory distress syndrome 21.90 18.84 15 80516 30093 42510711
Adverse reaction 21.79 18.84 32 80499 3961 42536843
Adverse drug reaction 21.74 18.84 133 80398 37301 42503503
Full blood count decreased 21.65 18.84 6 80525 20554 42520250
Full blood count abnormal 21.58 18.84 15 80516 29861 42510943
Metabolic acidosis 21.28 18.84 41 80490 51817 42488987
Aspiration 21.26 18.84 4 80527 17882 42522922
Rheumatoid lung 21.19 18.84 16 80515 908 42539896
Stent placement 21.07 18.84 37 80494 5323 42535481
Skin ulcer 21.01 18.84 100 80431 25501 42515303
Presyncope 20.98 18.84 8 80523 22379 42518425
Hepatic fibrosis 20.95 18.84 35 80496 4837 42535967
Tinnitus 20.90 18.84 109 80422 28829 42511975
Incorrect route of product administration 20.69 18.84 10 80521 24295 42516509
Angina pectoris 20.65 18.84 19 80512 32877 42507927
Bursitis 20.64 18.84 40 80491 6204 42534600
Hepatitis B virus test positive 20.59 18.84 11 80520 339 42540465
Emotional distress 20.46 18.84 3 80528 16090 42524714
Abdominal pain 20.38 18.84 246 80285 190225 42350579
Blood potassium increased 20.30 18.84 5 80526 18531 42522273
Heart rate increased 20.25 18.84 44 80487 53211 42487593
Carpal tunnel syndrome 20.19 18.84 37 80494 5502 42535302
Aspergillus infection 20.03 18.84 3 80528 15834 42524970
Acute hepatic failure 19.91 18.84 4 80527 17069 42523735
Oropharyngeal pain 19.83 18.84 143 80388 42367 42498437
Swollen tongue 19.71 18.84 86 80445 21145 42519659
Gastric bypass 19.69 18.84 10 80521 277 42540527
Pulmonary hypertension 19.60 18.84 10 80521 23559 42517245
Blood potassium decreased 19.59 18.84 7 80524 20377 42520427
Arteriosclerosis 19.41 18.84 5 80526 17984 42522820
Ileus 19.39 18.84 6 80525 19133 42521671
Abdominal distension 19.31 18.84 70 80461 71665 42469139
Rheumatoid nodule 19.31 18.84 26 80505 2969 42537835
Infection susceptibility increased 19.28 18.84 16 80515 1042 42539762
Speech disorder 19.27 18.84 16 80515 29105 42511699
Intentional overdose 19.16 18.84 43 80488 51413 42489391
Unevaluable event 19.04 18.84 22 80509 34266 42506538
Large intestine polyp 18.95 18.84 49 80482 9216 42531588
Cutaneous symptom 18.89 18.84 11 80520 402 42540402

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 6712.15 16.79 21048 594998 1499492 108473761
Condition aggravated 4439.33 16.79 11425 604621 723411 109249842
Product dose omission in error 3841.53 16.79 2093 613953 21419 109951834
Joint swelling 3784.66 16.79 7899 608147 434946 109538307
Pain 3575.75 16.79 12540 603506 942415 109030838
Arthralgia 3326.85 16.79 10703 605343 768929 109204324
Synovitis 2932.44 16.79 5378 610668 268714 109704539
Acute kidney injury 2762.63 16.79 204 615842 635226 109338027
Therapeutic product effect incomplete 2553.31 16.79 4517 611529 219288 109753965
Drug intolerance 2471.46 16.79 6346 609700 400166 109573087
Musculoskeletal stiffness 2397.30 16.79 5001 611045 274821 109698432
Arthropathy 2160.53 16.79 4874 611172 282648 109690605
Contraindicated product administered 2101.40 16.79 4416 611630 243851 109729402
Toxicity to various agents 2071.36 16.79 160 615886 480395 109492858
Therapeutic product effect decreased 2011.32 16.79 4297 611749 240019 109733234
Product dose omission issue 1995.36 16.79 5063 610983 316719 109656534
Discouragement 1984.13 16.79 660 615386 1538 109971715
Treatment failure 1958.40 16.79 4587 611459 272647 109700606
Hypotension 1943.53 16.79 299 615747 523550 109449703
Drug interaction 1740.20 16.79 338 615708 499845 109473408
Abdominal discomfort 1657.85 16.79 5391 610655 388467 109584786
Febrile neutropenia 1639.90 16.79 24 616022 316743 109656510
Swelling 1619.43 16.79 4960 611086 346081 109627172
Hand deformity 1605.77 16.79 3673 612373 214833 109758420
Sensitivity to weather change 1602.61 16.79 880 615166 9148 109964105
Blood cholesterol increased 1568.67 16.79 3292 612754 181493 109791760
Peripheral swelling 1526.08 16.79 5333 610713 398701 109574552
Illness 1440.01 16.79 2021 614025 80150 109893103
Neutropenia 1432.53 16.79 195 615851 374425 109598828
Hepatic enzyme increased 1406.57 16.79 4455 611591 316437 109656816
Systemic lupus erythematosus 1362.58 16.79 3792 612254 250546 109722707
Anaemia 1343.15 16.79 686 615360 546400 109426853
Alopecia 1319.81 16.79 4748 611298 360005 109613248
Glossodynia 1316.80 16.79 3437 612609 218567 109754686
Completed suicide 1307.83 16.79 7 616039 242374 109730879
Pemphigus 1277.80 16.79 3327 612719 211243 109762010
Anti-cyclic citrullinated peptide antibody positive 1224.26 16.79 2956 613090 179028 109794225
Nasopharyngitis 1221.61 16.79 4885 611161 389476 109583777
Pain in extremity 1125.59 16.79 5528 610518 481590 109491663
Wound 1039.57 16.79 3269 612777 231168 109742085
Infection 1030.97 16.79 4372 611674 357828 109615425
Herpes zoster 1029.80 16.79 2024 614022 106355 109866898
Rheumatoid factor positive 1007.69 16.79 2250 613796 129390 109843863
Death 975.81 16.79 1491 614555 697378 109275875
Hyponatraemia 964.22 16.79 63 615983 217590 109755663
Drug abuse 952.44 16.79 6 616040 177405 109795848
C-reactive protein abnormal 950.68 16.79 2179 613867 127516 109845737
Pericarditis 948.22 16.79 3030 613016 216084 109757169
Helicobacter infection 933.61 16.79 2671 613375 179206 109794047
COVID-19 928.41 16.79 3240 612806 241820 109731433
Sinusitis 917.05 16.79 3674 612372 293014 109680239
Malignant neoplasm progression 904.09 16.79 13 616033 174554 109798699
Loss of personal independence in daily activities 901.74 16.79 2335 613711 147685 109825568
Dehydration 892.44 16.79 228 615818 279283 109693970
Rheumatoid arthritis 879.10 16.79 3651 612395 295962 109677291
Inflammation 860.55 16.79 2699 613347 190539 109782714
Pancytopenia 850.51 16.79 89 615957 209524 109763729
Cardiac arrest 839.85 16.79 68 615978 196685 109776568
Duodenal ulcer perforation 834.04 16.79 2528 613518 175172 109798081
Thrombocytopenia 792.58 16.79 481 615565 348404 109624849
Seizure 784.28 16.79 142 615904 221043 109752210
Hypersensitivity 778.81 16.79 4362 611684 399636 109573617
Impaired healing 745.81 16.79 2602 613444 194115 109779138
Disease progression 737.99 16.79 221 615825 243813 109729440
Respiratory failure 732.35 16.79 153 615893 215179 109758074
Sepsis 730.09 16.79 461 615585 326885 109646368
Bradycardia 697.76 16.79 42 616004 155475 109817778
Discomfort 696.32 16.79 2700 613346 212007 109761246
Irritable bowel syndrome 686.74 16.79 2245 613801 161970 109811283
Red blood cell sedimentation rate increased 680.10 16.79 1409 614637 76893 109896360
Hyperkalaemia 679.21 16.79 16 616030 135780 109837473
Mobility decreased 674.90 16.79 2866 613180 234556 109738697
Intentional overdose 673.03 16.79 13 616033 132488 109840765
Folliculitis 668.15 16.79 2255 613791 165398 109807855
Therapeutic response unexpected 660.75 16.79 738 615308 23105 109950148
Dyspnoea 658.82 16.79 3555 612491 1103317 108869936
Drug hypersensitivity 645.88 16.79 4536 611510 449554 109523699
Headache 645.60 16.79 7628 608418 874749 109098504
Arthritis 644.97 16.79 2228 613818 165358 109807895
Multiple organ dysfunction syndrome 637.63 16.79 56 615990 151654 109821599
Platelet count decreased 632.14 16.79 246 615800 230197 109743056
Muscle injury 631.54 16.79 1972 614074 138835 109834418
Fibromyalgia 629.96 16.79 2240 613806 168669 109804584
Osteoarthritis 612.13 16.79 2321 613725 180302 109792951
Cardio-respiratory arrest 611.54 16.79 6 616040 115830 109857423
Rhabdomyolysis 610.77 16.79 12 616034 120389 109852864
Injection site pain 610.00 16.79 124 615922 177798 109795455
Therapy interrupted 594.76 16.79 1027 615019 48795 109924458
Gastrointestinal haemorrhage 582.97 16.79 108 615938 165410 109807843
Somnolence 582.15 16.79 481 615565 296968 109676285
Hypoxia 574.95 16.79 37 616009 129478 109843775
Sleep disorder due to general medical condition, insomnia type 569.73 16.79 1580 614466 104063 109869190
Tachycardia 569.21 16.79 275 615771 226370 109746883
Joint range of motion decreased 568.40 16.79 1730 614316 120102 109853151
Renal failure 562.82 16.79 279 615767 226295 109746958
Depressed level of consciousness 562.40 16.79 13 616033 112265 109860988
Syncope 554.19 16.79 217 615829 202319 109770934
Joint stiffness 553.71 16.79 1184 614862 66059 109907194
Oxygen saturation decreased 543.17 16.79 107 615939 156875 109816378
Red blood cell sedimentation rate abnormal 542.13 16.79 676 615370 23833 109949420
Hypokalaemia 535.82 16.79 174 615872 182274 109790979
Knee arthroplasty 532.97 16.79 1142 614904 63806 109909447
Product use issue 532.51 16.79 3261 612785 308434 109664819
Atrial fibrillation 532.01 16.79 309 615737 229333 109743920
Rheumatic fever 528.83 16.79 1694 614352 120885 109852368
Coma 528.23 16.79 32 616014 117837 109855416
Hypoglycaemia 524.95 16.79 30 616016 116074 109857179
Neutrophil count decreased 521.08 16.79 40 616006 120901 109852352
Intentional dose omission 519.88 16.79 600 615446 19480 109953773
Cardiac failure 503.58 16.79 207 615839 187419 109785834
Suicide attempt 502.88 16.79 16 616030 103378 109869875
Metabolic acidosis 494.05 16.79 13 616033 99731 109873522
Agitation 485.35 16.79 38 616008 113013 109860240
Lactic acidosis 480.11 16.79 7 616039 92804 109880449
Gastrointestinal disorder 476.64 16.79 2629 613417 239323 109733930
Ill-defined disorder 474.93 16.79 1931 614115 154922 109818331
Blister 470.44 16.79 2504 613542 224872 109748381
Infusion related reaction 450.98 16.79 3647 612399 377515 109595738
Ascites 445.59 16.79 16 616030 92792 109880461
International normalised ratio increased 442.74 16.79 8 616038 86764 109886489
Hallucination 441.39 16.79 32 616014 101400 109871853
Memory impairment 434.43 16.79 2208 613838 194736 109778517
Overdose 430.84 16.79 400 615646 233394 109739859
Pleural effusion 427.64 16.79 228 615818 177481 109795772
Tremor 424.89 16.79 304 615742 201928 109771325
Encephalopathy 407.44 16.79 9 616037 81046 109892207
Vomiting 407.42 16.79 3187 612859 907488 109065765
Swollen joint count increased 403.34 16.79 1202 614844 82459 109890794
Drug reaction with eosinophilia and systemic symptoms 398.19 16.79 13 616033 82082 109891171
Angioedema 396.42 16.79 43 616003 98457 109874796
Blood pressure decreased 392.81 16.79 81 615965 115010 109858243
Tuberculin test positive 386.57 16.79 246 615800 3422 109969831
Stomatitis 385.64 16.79 2703 613343 267539 109705714
Hip arthroplasty 380.64 16.79 912 615134 54901 109918352
Type 2 diabetes mellitus 376.93 16.79 1967 614079 175265 109797988
Chest discomfort 376.25 16.79 253 615793 173595 109799658
Musculoskeletal pain 367.91 16.79 2000 614046 181023 109792230
Myelosuppression 367.67 16.79 46 616000 94294 109878959
Sedation 365.99 16.79 4 616042 69679 109903574
Haemoglobin decreased 365.46 16.79 511 615535 248216 109725037
Blood creatinine increased 364.84 16.79 290 615756 182599 109790654
Cytokine release syndrome 360.69 16.79 6 616040 70300 109902953
Dysarthria 359.07 16.79 29 616017 84092 109889161
Hyperglycaemia 358.62 16.79 31 616015 85059 109888194
Bone erosion 356.14 16.79 794 615252 45577 109927676
Rheumatoid nodule 352.07 16.79 497 615549 19799 109953454
Septic shock 349.38 16.79 223 615823 157305 109815948
Rash 341.24 16.79 6442 609604 814522 109158731
Neuropathy peripheral 339.48 16.79 299 615747 178978 109794275
Cardiac failure congestive 338.68 16.79 211 615835 150789 109822464
Pneumonia aspiration 330.65 16.79 34 616012 81199 109892054
Hepatic function abnormal 330.43 16.79 51 615995 89244 109884009
Fatigue 329.96 16.79 8981 607065 1206977 108766276
Cholestasis 328.95 16.79 6 616040 64512 109908741
Mental status changes 328.40 16.79 25 616021 76097 109897156
Grip strength decreased 326.81 16.79 1087 614959 79087 109894166
Agranulocytosis 317.98 16.79 5 616041 61755 109911498
C-reactive protein increased 313.93 16.79 2185 613861 215734 109757519
Unresponsive to stimuli 313.36 16.79 9 616037 63781 109909472
Constipation 313.27 16.79 987 615059 356799 109616454
Lower respiratory tract infection 313.14 16.79 2373 613673 240733 109732520
Acne 309.73 16.79 619 615427 32901 109940352
Serotonin syndrome 307.96 16.79 4 616042 59149 109914104
Dysphagia 305.80 16.79 244 615802 153356 109819897
Mucosal inflammation 305.54 16.79 79 615967 96062 109877191
Suicidal ideation 304.70 16.79 74 615972 93863 109879390
Drug effective for unapproved indication 304.15 16.79 385 615661 13782 109959471
Hypomagnesaemia 294.80 16.79 9 616037 60361 109912892
Blood bilirubin increased 293.74 16.79 38 616008 75934 109897319
Cognitive disorder 293.69 16.79 64 615982 87447 109885806
Respiratory distress 290.50 16.79 25 616021 68849 109904404
Incorrect dose administered 290.16 16.79 107 615939 103534 109869719
White blood cell count decreased 288.08 16.79 523 615523 228867 109744386
Acute respiratory failure 287.74 16.79 39 616007 75221 109898032
Cardiogenic shock 285.74 16.79 7 616039 57331 109915922
Bursitis 284.57 16.79 1454 614592 128464 109844789
Haematuria 284.11 16.79 58 615988 82947 109890306
Urinary retention 284.05 16.79 29 616017 69654 109903599
Disorientation 284.00 16.79 31 616015 70640 109902613
Asthenia 281.40 16.79 2469 613577 686530 109286723
Plasma cell myeloma 279.23 16.79 18 616028 62918 109910335
Weight increased 279.22 16.79 3567 612479 416077 109557176
Dyspnoea exertional 278.83 16.79 115 615931 103945 109869308
Facet joint syndrome 278.78 16.79 1174 614872 95654 109877599
Pulmonary oedema 278.32 16.79 106 615940 100553 109872700
Lip dry 277.75 16.79 1200 614846 98883 109874370
Respiratory arrest 276.60 16.79 11 616035 58288 109914965
Foot deformity 275.15 16.79 739 615307 47741 109925512
Orthostatic hypotension 274.17 16.79 26 616020 66223 109907030
Hepatic failure 274.09 16.79 31 616015 68708 109904545
Pyrexia 273 16.79 3450 612596 894815 109078438
Flushing 272.26 16.79 121 615925 104615 109868638
Loss of consciousness 271.04 16.79 421 615625 195885 109777368
Coronary artery disease 269.74 16.79 39 616007 71651 109901602
Hepatic cytolysis 269.58 16.79 8 616038 55045 109918208
Gastric disorder 266.14 16.79 580 615466 32777 109940476
Generalised tonic-clonic seizure 263.97 16.79 9 616037 54671 109918582
Renal impairment 262.23 16.79 402 615644 188043 109785210
Psoriatic arthropathy 260.88 16.79 1934 614112 194827 109778426
Pallor 260.21 16.79 13 616033 56454 109916799
Altered state of consciousness 260.14 16.79 15 616031 57611 109915642
Aggression 259.57 16.79 18 616028 59192 109914061
Malaise 259.23 16.79 5214 610832 666605 109306648
Psychotic disorder 258.62 16.79 5 616041 50932 109922321
Upper respiratory tract infection 257.72 16.79 1426 614620 129902 109843351
Melaena 255.02 16.79 39 616007 68718 109904535
Jaundice 253.99 16.79 20 616026 59216 109914037
Accidental exposure to product 253.53 16.79 5 616041 50003 109923250
Sleep disorder 253.49 16.79 1935 614111 196709 109776544
Maternal exposure during pregnancy 251.11 16.79 2343 613703 252540 109720713
Liver function test increased 250.56 16.79 1068 614978 87480 109885773
Neoplasm progression 250.48 16.79 32 616014 64563 109908690
Weight decreased 250.05 16.79 1554 614492 466503 109506750
Bone marrow failure 249.54 16.79 19 616027 57829 109915424
Hepatocellular injury 249.29 16.79 7 616039 50635 109922618
Chills 247.89 16.79 425 615621 190155 109783098
Lower limb fracture 247.60 16.79 952 615094 74396 109898857
Multiple sclerosis relapse 247.11 16.79 7 616039 50233 109923020
Heart rate decreased 246.32 16.79 77 615969 82679 109890574
Oedema peripheral 244.62 16.79 971 615075 327689 109645564
Eosinophilia 244.43 16.79 21 616025 57915 109915338
Epistaxis 243.72 16.79 220 615826 130152 109843101
Lethargy 240.27 16.79 110 615936 93466 109879787
Gait inability 238.37 16.79 1436 614610 134940 109838313
Drug level increased 237.13 16.79 6 616040 47713 109925540
Shock 235.76 16.79 16 616030 53572 109919681
Osteonecrosis of jaw 235.04 16.79 7 616039 48010 109925243
Acute myocardial infarction 233.67 16.79 87 615959 83690 109889563
Ventricular tachycardia 232.09 16.79 11 616035 49998 109923255
Cerebral haemorrhage 231.70 16.79 41 616005 64927 109908326
Hypophagia 230.69 16.79 16 616030 52610 109920643
Haemoptysis 229.88 16.79 57 615989 71297 109901956
Upper gastrointestinal haemorrhage 229.36 16.79 12 616034 50084 109923169
Hypervolaemia 229.15 16.79 11 616035 49449 109923804
Obstructive airways disorder 228.58 16.79 6 616040 46143 109927110
Pneumonia 228.12 16.79 3474 612572 873240 109100013
Peripheral venous disease 222.32 16.79 994 615052 83123 109890130
Aphasia 222.18 16.79 32 616014 58965 109914288
Stevens-Johnson syndrome 222.00 16.79 9 616037 46892 109926361
Balance disorder 221.11 16.79 194 615852 116366 109856887
Pancreatitis acute 219.45 16.79 36 616010 60238 109913015
Liver injury 217.03 16.79 1509 614537 148904 109824349
Blood glucose increased 216.54 16.79 251 615795 132245 109841008
Injection site erythema 216.18 16.79 128 615918 94048 109879205
Blood urea increased 216.09 16.79 26 616020 54931 109918322
Sinus tachycardia 215.93 16.79 7 616039 44486 109928767
Injury 213.02 16.79 1703 614343 175562 109797691
Heart rate increased 212.69 16.79 294 615752 143540 109829713
Haematoma 210.52 16.79 36 616010 58440 109914813
Ventricular fibrillation 209.97 16.79 4 616042 41309 109931944
Fall 208.10 16.79 2253 613793 601229 109372024
Pulmonary hypertension 207.84 16.79 30 616016 55190 109918063
Circulatory collapse 207.81 16.79 7 616039 42986 109930267
Mycobacterium tuberculosis complex test positive 207.29 16.79 161 615885 3127 109970126
Contusion 206.69 16.79 2098 613948 231263 109741990
Night sweats 205.72 16.79 1365 614681 132618 109840635
Blood alkaline phosphatase increased 204.08 16.79 70 615976 70865 109902388
Adverse event 200.62 16.79 1162 614884 107647 109865606
Rash maculo-papular 200.51 16.79 81 615965 74141 109899112
Ejection fraction decreased 199.95 16.79 6 616040 40874 109932379
Arrhythmia 199.58 16.79 69 615977 69506 109903747
Restlessness 199.56 16.79 36 616010 56223 109917030
Wrong technique in product usage process 198.70 16.79 120 615926 87228 109886025
Sciatica 198.06 16.79 1028 615018 91371 109881882
Dry skin 196.08 16.79 186 615860 107467 109865786
Injection site swelling 195.90 16.79 51 615995 61739 109911514
Pericardial effusion 195.78 16.79 40 616006 57177 109916076
Inappropriate schedule of product administration 193.84 16.79 540 615506 203097 109770156
Spinal operation 193.75 16.79 271 615775 10701 109962552
Vision blurred 193.51 16.79 261 615785 128761 109844492
Drug withdrawal syndrome 192.14 16.79 4 616042 38050 109935203
Frequent bowel movements 191.22 16.79 847 615199 70543 109902710
Abdominal pain 188.29 16.79 1887 614159 511102 109462151
Acute hepatic failure 187.53 16.79 3 616043 36465 109936788
Haematemesis 186.98 16.79 49 615997 59059 109914194
Dyskinesia 186.69 16.79 31 616015 51415 109921838
Abnormal behaviour 186.45 16.79 7 616039 39032 109934221
Dry mouth 185.95 16.79 1816 614230 198132 109775121
Leukocytosis 185.49 16.79 37 616009 53791 109919462
Hemiparesis 184.98 16.79 16 616030 43887 109929366
Abdominal pain upper 184.26 16.79 2849 613197 346262 109626991
Pulmonary fibrosis 183.76 16.79 1083 614963 100959 109872294
Osteoporosis 183.61 16.79 965 615081 86187 109887066
Gamma-glutamyltransferase increased 182.54 16.79 57 615989 61252 109912001
Acute respiratory distress syndrome 180.35 16.79 38 616008 53160 109920093
Myocardial infarction 179.40 16.79 514 615532 191569 109781684
Drug tolerance decreased 178.14 16.79 441 615605 27099 109946154
Cerebral infarction 177.86 16.79 36 616010 51802 109921451
Pulmonary embolism 173.62 16.79 612 615434 213862 109759391
Diabetic ketoacidosis 172.73 16.79 17 616029 42041 109931212
Electrolyte imbalance 172.30 16.79 8 616038 37020 109936233
Anaphylactic shock 170.33 16.79 39 616007 51507 109921746
Skin exfoliation 169.76 16.79 143 615903 87508 109885745
Device issue 169.16 16.79 5 616041 34530 109938723
Angina pectoris 168.25 16.79 68 615978 62227 109911026
Hyperhidrosis 167.11 16.79 512 615534 186786 109786467
Subdural haematoma 166.05 16.79 9 616037 36445 109936808
Blood parathyroid hormone decreased 165.67 16.79 277 615769 12812 109960441
Prescribed overdose 165.17 16.79 941 615105 86640 109886613
Obesity 164.56 16.79 1139 614907 112212 109861041
Disturbance in attention 163.69 16.79 70 615976 61925 109911328
Blood creatine phosphokinase increased 161.24 16.79 104 615942 72973 109900280
Injection site haemorrhage 160.98 16.79 5 616041 33023 109940230
Granuloma skin 160.82 16.79 252 615794 11031 109962222
Status epilepticus 160.68 16.79 3 616043 31568 109941685
Acute myeloid leukaemia 160.26 16.79 14 616032 38096 109935157
Hypoaesthesia 159.22 16.79 2547 613499 311676 109661577
Ischaemic stroke 158.64 16.79 21 616025 41242 109932011
Device dislocation 157.48 16.79 4 616042 31700 109941553
Knee operation 155.79 16.79 194 615852 6828 109966425
Joint injury 155.67 16.79 534 615512 39460 109933793
Transient ischaemic attack 155.46 16.79 81 615965 63901 109909352
Disseminated intravascular coagulation 154.06 16.79 23 616023 41263 109931990
Myoclonus 153.97 16.79 7 616039 32991 109940262
Nodule 153.60 16.79 465 615581 32166 109941087
Face oedema 153.28 16.79 8 616038 33461 109939792
Erythema 152.72 16.79 973 615073 290474 109682779
Aspartate aminotransferase increased 151.53 16.79 425 615621 159511 109813742
Wound infection 151.23 16.79 988 615058 95477 109877776
Nail disorder 151.12 16.79 682 615364 57253 109916000
Pneumonitis 150.51 16.79 123 615923 76408 109896845
Cholelithiasis 150.13 16.79 83 615963 63339 109909914
Nausea 150.08 16.79 5504 610542 1230186 108743067
Tumour lysis syndrome 148.92 16.79 5 616041 30796 109942457
Dislocation of vertebra 148.23 16.79 558 615488 43163 109930090
Blood lactate dehydrogenase increased 147.58 16.79 33 616013 44301 109928952
Intentional product use issue 147.19 16.79 2065 613981 245841 109727412
Deep vein thrombosis postoperative 146.53 16.79 687 615359 58604 109914649
Leukopenia 146.50 16.79 388 615658 148403 109824850
Presyncope 146.36 16.79 45 616001 48842 109924411
Alanine aminotransferase increased 146.33 16.79 528 615518 183245 109790008
Coagulopathy 145.49 16.79 26 616020 40885 109932368
Ataxia 145.18 16.79 5 616041 30103 109943150
Injection site pruritus 145.02 16.79 52 615994 51206 109922047
Blood pressure fluctuation 144.99 16.79 122 615924 74702 109898551
X-ray abnormal 144.07 16.79 504 615542 37613 109935640
Influenza 143.83 16.79 1508 614538 167593 109805660
Mitral valve incompetence 143.60 16.79 11 616035 33318 109939935
Thrombotic microangiopathy 143.58 16.79 4 616042 29145 109944108
Blood calcium decreased 143.32 16.79 16 616030 35829 109937424
Panniculitis 143.05 16.79 287 615759 15295 109957958
Road traffic accident 143.03 16.79 1057 614989 106341 109866912
Pulmonary arterial hypertension 142.46 16.79 10 616036 32558 109940695
Cerebrovascular accident 142.27 16.79 524 615522 180760 109792493
Intentional product misuse 141.63 16.79 1243 614803 131661 109841592
Dizziness 141.28 16.79 2892 613154 695301 109277952
Disability 140.68 16.79 429 615617 29794 109943459
Brain oedema 140.65 16.79 8 616038 31090 109942163
Bacteraemia 140.21 16.79 32 616014 42358 109930895
Bronchospasm 139.21 16.79 7 616039 30232 109943021
Decreased appetite 139.17 16.79 1841 614205 474005 109499248
Rheumatoid factor negative 139.03 16.79 88 615958 1212 109972041
Toxic skin eruption 138.49 16.79 3 616043 27512 109945741
Chronic obstructive pulmonary disease 137.76 16.79 248 615798 108910 109864343
Onychomycosis 137.53 16.79 500 615546 38031 109935222
Palpitations 137.24 16.79 442 615604 158770 109814483
Shock haemorrhagic 137.03 16.79 3 616043 27244 109946009
Finger deformity 136.90 16.79 451 615595 32641 109940612
Troponin increased 136.68 16.79 7 616039 29759 109943494
Product administration error 136.00 16.79 22 616024 37195 109936058
Hypoalbuminaemia 135.67 16.79 6 616040 28968 109944285
Lung disorder 135.42 16.79 1567 614479 178480 109794773
Extrapyramidal disorder 135.10 16.79 6 616040 28861 109944392
Emotional distress 134.76 16.79 41 616005 44806 109928447
Impaired work ability 134.38 16.79 387 615659 26032 109947221
Immune system disorder 134.04 16.79 257 615789 13244 109960009
Polyneuropathy 133.96 16.79 12 616034 32000 109941253
Autoimmune disorder 133.77 16.79 719 615327 64764 109908489
Ileus 132.80 16.79 10 616036 30719 109942534
Hypothermia 131.87 16.79 3 616043 26299 109946954
Adverse drug reaction 131.64 16.79 1023 615023 104536 109868717
Blood pressure systolic increased 131.55 16.79 161 615885 82830 109890423
Hypothyroidism 131.53 16.79 127 615919 72772 109900481
Lymphocyte count decreased 131.09 16.79 78 615968 57165 109916088
Metastases to bone 130.64 16.79 12 616034 31360 109941893
Haemorrhage intracranial 129.36 16.79 8 616038 28961 109944292
Hallucination, auditory 128.65 16.79 4 616042 26393 109946860
Urinary incontinence 128.05 16.79 55 615991 48532 109924721
Onychomadesis 126.26 16.79 547 615499 45116 109928137
Exostosis 125.91 16.79 549 615497 45407 109927846
Depressed mood 125.12 16.79 669 615377 60140 109913113
Cytomegalovirus infection 124.94 16.79 74 615972 54370 109918883
Breast cancer stage III 124.42 16.79 811 615235 78306 109894947
Neck pain 124.23 16.79 1138 614908 121992 109851261
Adjustment disorder with depressed mood 123.89 16.79 529 615517 43354 109929899
Foot operation 123.77 16.79 177 615869 7136 109966117
Full blood count abnormal 123.35 16.79 80 615966 55972 109917281
Joint effusion 123.00 16.79 323 615723 20582 109952671
Poisoning 121.55 16.79 11 616035 29094 109944159
Liver disorder 121.20 16.79 1269 614777 140974 109832279
Pre-existing condition improved 120.96 16.79 165 615881 6361 109966892
Blood potassium decreased 119.40 16.79 77 615969 54037 109919216
Joint dislocation 118.94 16.79 440 615606 33750 109939503
Lymphopenia 118.42 16.79 38 616008 40132 109933121
Delusion 117.98 16.79 3 616043 23752 109949501
Chronic kidney disease 117.80 16.79 151 615895 76140 109897113
Hypocalcaemia 117.79 16.79 114 615932 65252 109908001
Coeliac disease 117.62 16.79 515 615531 42672 109930581
Visual acuity reduced 117.60 16.79 19 616027 32154 109941099
Device malfunction 117.39 16.79 6 616040 25552 109947701
Cyanosis 117.10 16.79 14 616032 29727 109943526
Muscle rigidity 115.84 16.79 4 616042 24027 109949226
Labelled drug-drug interaction medication error 114.86 16.79 14 616032 29288 109943965
Respiratory rate increased 114.85 16.79 6 616040 25077 109948176
Intestinal obstruction 114.39 16.79 78 615968 53149 109920104
Cardiomegaly 113.99 16.79 14 616032 29116 109944137
Clostridium difficile colitis 113.09 16.79 51 615995 43727 109929526
Left ventricular dysfunction 112.93 16.79 4 616042 23489 109949764
Diplopia 112.70 16.79 46 616000 41848 109931405
Rhinorrhoea 112.40 16.79 966 615080 101700 109871553
Hyperthyroidism 112.23 16.79 15 616031 29246 109944007
Acidosis 111.32 16.79 3 616043 22528 109950725
Myelodysplastic syndrome 111.32 16.79 35 616011 37449 109935804
Nephropathy toxic 110.53 16.79 12 616034 27466 109945787
Paranoia 110.47 16.79 3 616043 22371 109950882
Coordination abnormal 109.62 16.79 8 616038 25220 109948033
Proteinuria 109.19 16.79 43 616003 39975 109933278
Renal tubular necrosis 109.17 16.79 19 616027 30456 109942797
Transaminases increased 109.15 16.79 115 615931 63275 109909978
Ear infection 108.57 16.79 659 615387 62073 109911180
Withdrawal syndrome 107.23 16.79 22 616024 31358 109941895
Metastases to liver 106.96 16.79 32 616014 35354 109937899
Productive cough 106.60 16.79 306 615740 113999 109859254
Lip swelling 106.56 16.79 76 615970 50591 109922662
Injection site mass 106.39 16.79 8 616038 24605 109948648
Transplant rejection 106.15 16.79 8 616038 24559 109948694
End stage renal disease 105.57 16.79 3 616043 21470 109951783
Myopathy 105.42 16.79 9 616037 24951 109948302
Colitis 105.21 16.79 261 615785 102062 109871191
Myocarditis 104.95 16.79 20 616026 30035 109943218
Hypercholesterolaemia 104.90 16.79 865 615181 89972 109883281
Full blood count decreased 104.64 16.79 25 616021 32074 109941179
Tubulointerstitial nephritis 104.58 16.79 89 615957 54195 109919058
Rales 104.27 16.79 9 616037 24730 109948523
Immune thrombocytopenia 104.21 16.79 5 616041 22489 109950764
Migraine 103.12 16.79 1433 614613 170219 109803034
Acute generalised exanthematous pustulosis 103.07 16.79 4 616042 21660 109951593
Right ventricular failure 102.73 16.79 12 616034 25942 109947311
Hemiplegia 102.61 16.79 6 616040 22776 109950477
Paraesthesia oral 102.60 16.79 30 616016 33641 109939612
Malnutrition 102.24 16.79 15 616031 27264 109945989
Drug resistance 101.95 16.79 98 615948 56276 109916977
Haematocrit decreased 101.94 16.79 131 615915 65986 109907267
Limb discomfort 101.41 16.79 474 615572 40380 109932873
Anti-cyclic citrullinated peptide antibody 101.11 16.79 292 615754 19672 109953581
Dermatitis atopic 100.62 16.79 12 616034 25529 109947724
Creatinine renal clearance decreased 100.58 16.79 5 616041 21810 109951443
Generalised oedema 99.92 16.79 24 616022 30680 109942573
Metastases to central nervous system 99.82 16.79 7 616039 22810 109950443
Aspiration 99.11 16.79 24 616022 30509 109942744
Blepharospasm 98.63 16.79 582 615464 54269 109918984
Abortion spontaneous 98.32 16.79 34 616012 34248 109939005
Neoplasm malignant 98.18 16.79 439 615607 36704 109936549
Therapeutic product effect delayed 98.18 16.79 123 615923 4356 109968897
Progressive multifocal leukoencephalopathy 97.64 16.79 12 616034 24944 109948309
Klebsiella infection 97.63 16.79 3 616043 20006 109953247
Musculoskeletal disorder 97.46 16.79 313 615733 22351 109950902
Tricuspid valve incompetence 97.12 16.79 10 616036 23863 109949390
C-reactive protein 96.99 16.79 380 615666 29951 109943302
Erythema multiforme 96.75 16.79 5 616041 21092 109952161
Hypovolaemia 96.74 16.79 6 616040 21668 109951585
Cardiomyopathy 96.57 16.79 33 616013 33492 109939761
Small intestinal obstruction 95.80 16.79 30 616016 32183 109941070
Dialysis 95.51 16.79 3 616043 19616 109953637
Joint laxity 95.41 16.79 92 615954 2415 109970838
Blood sodium decreased 95.36 16.79 47 615999 38272 109934981
Laryngitis 95.15 16.79 478 615568 41933 109931320
Spinal stenosis 94.86 16.79 277 615769 18779 109954474
Sudden death 94.78 16.79 12 616034 24383 109948870
Anxiety 94.39 16.79 1353 614693 343725 109629528
Subarachnoid haemorrhage 93.23 16.79 25 616021 29677 109943576
Acute coronary syndrome 93.21 16.79 10 616036 23102 109950151
Transfusion 93.20 16.79 15 616031 25457 109947796
Device related infection 93.13 16.79 52 615994 39467 109933786
Splenomegaly 92.92 16.79 13 616033 24485 109948768
Polyarthritis 92.82 16.79 274 615772 18689 109954564
Drug effect less than expected 92.76 16.79 155 615891 7165 109966088
Mania 92.09 16.79 6 616040 20790 109952463
Back disorder 91.84 16.79 291 615755 20631 109952622
Schizophrenia 91.83 16.79 8 616038 21818 109951435
Hydronephrosis 91.40 16.79 6 616040 20659 109952594
Atrioventricular block complete 91.34 16.79 5 616041 20077 109953176
Blood pressure diastolic decreased 90.85 16.79 43 616003 35842 109937411
Cardiac failure acute 90.80 16.79 13 616033 24065 109949188
Oliguria 90.30 16.79 3 616043 18654 109954599
Cellulitis 89.46 16.79 379 615667 125637 109847616
Atrial flutter 89.42 16.79 14 616032 24248 109949005
Injection site bruising 89.39 16.79 92 615954 51171 109922082
Joint lock 89.17 16.79 105 615941 3483 109969770
Lung infiltration 89.00 16.79 15 616031 24613 109948640
Bowel movement irregularity 88.91 16.79 156 615890 7504 109965749
Joint arthroplasty 88.73 16.79 104 615942 3433 109969820
Myocardial ischaemia 88.54 16.79 20 616026 26664 109946589
Retinitis 88.42 16.79 386 615660 31941 109941312
Rheumatoid lung 87.73 16.79 114 615932 4190 109969063
Arteriosclerosis 87.51 16.79 16 616030 24751 109948502
Arteriosclerosis coronary artery 87.10 16.79 17 616029 25101 109948152
Therapy partial responder 87.00 16.79 49 615997 37012 109936241
Dyspepsia 86.77 16.79 1521 614525 189444 109783809
Irritability 86.58 16.79 83 615963 47726 109925527
Procedural pain 86.44 16.79 45 616001 35520 109937733
Needle issue 85.89 16.79 3 616043 17837 109955416
Treatment noncompliance 85.81 16.79 173 615873 72817 109900436
Product substitution issue 85.70 16.79 13 616033 23048 109950205
Aspergillus infection 85.40 16.79 19 616027 25597 109947656
Eosinophil count increased 85.21 16.79 9 616037 21049 109952204
Speech disorder 84.97 16.79 132 615914 61437 109911816
Hepatitis acute 84.35 16.79 5 616041 18761 109954492
Purpura 83.53 16.79 17 616029 24371 109948882
Blood loss anaemia 83.53 16.79 4 616042 18021 109955232
Hypertension 83.33 16.79 3555 612491 506529 109466724
Haemolytic anaemia 81.99 16.79 10 616036 20910 109952343
Diverticulitis 81.94 16.79 545 615501 52977 109920276
Skin cancer 81.43 16.79 251 615795 17533 109955720
Haemorrhage 81.34 16.79 312 615734 106380 109866873
Acute pulmonary oedema 81.33 16.79 3 616043 16993 109956260
Gastritis 81.14 16.79 108 615938 53591 109919662
Pemphigoid 80.84 16.79 8 616038 19699 109953554
Body temperature increased 80.69 16.79 112 615934 54601 109918652
Pulmonary alveolar haemorrhage 80.54 16.79 9 616037 20141 109953112
Deformity 80.29 16.79 176 615870 9984 109963269
Myalgia 80.20 16.79 821 615225 221560 109751693
Supraventricular tachycardia 79.65 16.79 19 616027 24403 109948850
Peritonitis 79.63 16.79 41 616005 32566 109940687
Prothrombin time prolonged 79.44 16.79 4 616042 17257 109955996
Eczema 79.43 16.79 178 615868 72115 109901138
Pseudomonas infection 79.23 16.79 28 616018 27825 109945428
Unevaluable event 78.89 16.79 130 615916 59097 109914156
Petechiae 78.33 16.79 17 616029 23300 109949953
Haematotoxicity 78.08 16.79 12 616034 21070 109952183
No adverse event 77.75 16.79 186 615860 73653 109899600
Live birth 77.74 16.79 657 615389 68827 109904426
Chondropathy 77.65 16.79 88 615958 2799 109970454
Cholecystitis 77.16 16.79 24 616022 25858 109947395
Ventricular extrasystoles 77.10 16.79 16 616030 22625 109950628
Enterocolitis 76.93 16.79 8 616038 18941 109954312
Seronegative arthritis 76.92 16.79 203 615843 12974 109960279
Lupus vulgaris 76.80 16.79 383 615663 33500 109939753
Oral candidiasis 76.17 16.79 82 615964 44678 109928575
Blood uric acid increased 75.87 16.79 14 616032 21515 109951738
Benign prostatic hyperplasia 75.86 16.79 7 616039 18227 109955026
Oral mucosal exfoliation 75.78 16.79 67 615979 1569 109971684
Tenosynovitis 75.66 16.79 231 615815 16052 109957201
Dermatitis bullous 74.92 16.79 6 616040 17523 109955730
Prescribed underdose 74.91 16.79 620 615426 64554 109908699
Diabetes mellitus inadequate control 74.88 16.79 36 616010 29739 109943514
Chest pain 74.48 16.79 1564 614482 374811 109598442
Psychomotor hyperactivity 74.06 16.79 12 616034 20265 109952988
Joint destruction 73.71 16.79 178 615868 10765 109962488
Deep vein thrombosis 73.22 16.79 467 615579 139420 109833833
Dysuria 73.19 16.79 140 615906 60091 109913162
Lipase increased 73.00 16.79 9 616037 18663 109954590
Neutrophil count increased 72.84 16.79 52 615994 34600 109938653
Urosepsis 72.81 16.79 40 616006 30635 109942618
Lupus-like syndrome 72.80 16.79 432 615614 40360 109932893
Poor venous access 72.64 16.79 23 616023 24499 109948754
Sleep apnoea syndrome 72.34 16.79 71 615975 40376 109932877
Apparent death 72.25 16.79 85 615961 2817 109970436
Drug tolerance 72.18 16.79 230 615816 16355 109956898
Blood albumin decreased 71.76 16.79 32 616014 27620 109945633
Vaginal haemorrhage 71.68 16.79 25 616021 25049 109948204
Hypotonia 71.36 16.79 4 616042 15741 109957512
Complication associated with device 70.85 16.79 13 616033 20060 109953193
Body temperature decreased 70.60 16.79 61 615985 36874 109936379
Hypertriglyceridaemia 70.54 16.79 5 616041 16149 109957104
Central nervous system lesion 70.34 16.79 4 616042 15549 109957704
Nasal congestion 69.72 16.79 846 615200 97436 109875817
Female genital tract fistula 69.65 16.79 6 616040 16513 109956740
Myasthenia gravis 69.64 16.79 17 616029 21494 109951759
Atlantoaxial instability 69.57 16.79 34 616012 271 109972982
Metastases to lung 69.45 16.79 21 616025 23042 109950211
Tooth infection 69.15 16.79 276 615770 21940 109951313
Encephalitis 69.14 16.79 11 616035 18828 109954425
Pneumothorax 69.01 16.79 57 615989 35228 109938025
Blood lactic acid increased 68.79 16.79 5 616041 15816 109957437
Synovial cyst 68.67 16.79 178 615868 11252 109962001
Electrocardiogram abnormal 68.49 16.79 11 616035 18698 109954555
Blood magnesium decreased 68.36 16.79 14 616032 19982 109953271
Pathogen resistance 67.92 16.79 9 616037 17663 109955590
Erectile dysfunction 67.73 16.79 11 616035 18545 109954708
Back injury 66.83 16.79 473 615573 46926 109926327
Skin necrosis 66.76 16.79 267 615779 21245 109952008
Pulmonary haemorrhage 66.67 16.79 7 616039 16449 109956804
Salivary hypersecretion 66.65 16.79 9 616037 17412 109955841
Renal injury 66.31 16.79 12 616034 18701 109954552
Swelling face 65.93 16.79 277 615769 92044 109881209
Urine output decreased 65.74 16.79 15 616031 19861 109953392
Dysgeusia 64.77 16.79 188 615858 69797 109903456
Hypogammaglobulinaemia 64.73 16.79 16 616030 20060 109953193
Maternal exposure timing unspecified 64.56 16.79 260 615786 20753 109952500
Tenderness 64.09 16.79 329 615717 29108 109944145
Prostate cancer 64.01 16.79 69 615977 37572 109935681
Gait disturbance 63.91 16.79 2015 614031 276193 109697060
Rash erythematous 63.87 16.79 237 615809 81595 109891658
Anaphylactic reaction 63.78 16.79 374 615672 113926 109859327
Congestive cardiomyopathy 63.27 16.79 4 616042 14215 109959038
Radiculopathy 63.15 16.79 15 616031 19321 109953932
Ulcer 62.99 16.79 434 615612 42682 109930571
Osteonecrosis 62.96 16.79 57 615989 33684 109939569
Peripheral sensory neuropathy 62.91 16.79 9 616037 16671 109956582
Gastroenteritis 62.84 16.79 74 615972 38726 109934527
Abdominal pain lower 62.67 16.79 69 615977 37214 109936039
Product use in unapproved indication 62.07 16.79 1958 614088 445419 109527834
Chronic sinusitis 62.06 16.79 31 616015 25053 109948200
Drug dose omission by device 61.95 16.79 5 616041 14511 109958742
Hepatitis B virus test positive 61.78 16.79 38 616008 496 109972757
Heart rate irregular 61.49 16.79 60 615986 34214 109939039
Bronchopulmonary aspergillosis 61.23 16.79 46 616000 29817 109943436
Gangrene 61.21 16.79 9 616037 16332 109956921
Cholangitis 61.18 16.79 9 616037 16326 109956927
Cardiac failure chronic 61.11 16.79 4 616042 13807 109959446
Throat tightness 60.81 16.79 58 615988 33431 109939822
Blood pressure diastolic abnormal 60.78 16.79 34 616012 25781 109947472
Dysphonia 60.51 16.79 218 615828 75711 109897542
Bacterial infection 60.43 16.79 102 615944 45934 109927319
Muscle twitching 60.25 16.79 47 615999 29888 109943365
Duodenal ulcer 60.17 16.79 17 616029 19497 109953756
Mineral metabolism disorder 59.95 16.79 34 616012 378 109972875
Fear 59.94 16.79 27 616019 23166 109950087
Cardiovascular disorder 59.60 16.79 26 616020 22734 109950519
Injection site rash 59.38 16.79 28 616018 23391 109949862
Post procedural haemorrhage 59.38 16.79 8 616038 15504 109957749
Immunodeficiency 58.56 16.79 394 615652 38444 109934809
Intestinal ischaemia 58.15 16.79 10 616036 16169 109957084
Lipids increased 58.00 16.79 63 615983 1910 109971343
Oesophagitis 57.90 16.79 45 616001 28670 109944583
Shoulder operation 57.74 16.79 83 615963 3362 109969891
Limb operation 57.52 16.79 90 615956 3934 109969319
Psoriasis 57.27 16.79 1097 614949 138896 109834357
Angina unstable 57.23 16.79 11 616035 16421 109956832
Hypovolaemic shock 57.08 16.79 7 616039 14576 109958677
Enterococcal infection 57.03 16.79 21 616025 20345 109952908
Sensory loss 57.00 16.79 24 616022 21433 109951820
Fear of injection 56.89 16.79 142 615904 8769 109964484
Head injury 56.75 16.79 95 615951 42922 109930331
Swollen tongue 56.71 16.79 161 615885 60201 109913052
Diastolic dysfunction 56.69 16.79 3 616043 12401 109960852
Oropharyngeal pain 56.35 16.79 1063 614983 134213 109839040
Panic attack 56.29 16.79 47 615999 28893 109944360
Bundle branch block right 56.09 16.79 3 616043 12288 109960965
Injection site warmth 55.87 16.79 14 616032 17391 109955862
Rebound effect 55.82 16.79 8 616038 14798 109958455
Eyelid oedema 55.81 16.79 9 616037 15253 109958000
Seborrhoea 55.64 16.79 36 616010 516 109972737
Trigger finger 55.64 16.79 101 615945 4991 109968262
Lower gastrointestinal haemorrhage 55.36 16.79 17 616029 18469 109954784
Coronary artery stenosis 55.36 16.79 6 616040 13752 109959501
Blood pressure systolic abnormal 55.31 16.79 35 616011 24815 109948438
Blood pressure increased 55.17 16.79 1060 614986 257313 109715940
Nasal polyps 55.09 16.79 5 616041 13195 109960058
Cerebral ischaemia 55.09 16.79 3 616043 12101 109961152
Spinal instability 55.07 16.79 34 616012 447 109972806
Neck deformity 55.05 16.79 60 615986 1826 109971427
Cytopenia 54.87 16.79 52 615994 30064 109943189
Product label confusion 54.74 16.79 261 615785 22416 109950837
Haematochezia 54.57 16.79 926 615120 114598 109858655
Vaginal discharge 54.48 16.79 16 616030 17892 109955361
Hyperuricaemia 54.44 16.79 8 616038 14523 109958730
Intestinal sepsis 54.43 16.79 45 616001 959 109972294
Stress cardiomyopathy 54.17 16.79 11 616035 15795 109957458
White blood cell count increased 53.96 16.79 317 615729 96525 109876728
Cytomegalovirus viraemia 53.81 16.79 16 616030 17748 109955505
Walking aid user 53.72 16.79 279 615767 24796 109948457
Mental disorder 53.68 16.79 83 615963 38708 109934545
Muscle spasms 53.61 16.79 1974 614072 276183 109697070
Nephrotic syndrome 53.26 16.79 7 616039 13824 109959429
Ileus paralytic 53.14 16.79 3 616043 11734 109961519
Injection site urticaria 53.07 16.79 15 616031 17200 109956053
Staphylococcal infection 53.01 16.79 205 615841 69739 109903514
Vertigo 52.97 16.79 276 615770 86594 109886659
Cystitis haemorrhagic 52.68 16.79 4 616042 12205 109961048
Ankle arthroplasty 52.67 16.79 68 615978 2483 109970770
Infusion site extravasation 52.59 16.79 3 616043 11631 109961622
Anger 52.55 16.79 20 616026 18987 109954266
Drug level above therapeutic 52.35 16.79 3 616043 11585 109961668
Vasculitis 52.33 16.79 74 615972 35799 109937454
Atelectasis 52.31 16.79 77 615969 36635 109936618
Nystagmus 52.29 16.79 3 616043 11574 109961679
Foot fracture 51.83 16.79 280 615766 25266 109947987
Hair growth abnormal 51.81 16.79 80 615966 3457 109969796
Pyelonephritis 51.64 16.79 39 616007 25211 109948042
Haemolysis 51.33 16.79 12 616034 15627 109957626
Blood glucose decreased 51.32 16.79 53 615993 29435 109943818
Elbow deformity 51.14 16.79 52 615994 1458 109971795
Blood potassium increased 51.12 16.79 66 615980 33183 109940070
Rhinitis allergic 51.00 16.79 18 616028 17904 109955349
Gastroenteritis viral 50.87 16.79 323 615723 30903 109942350
Hepatomegaly 50.71 16.79 28 616018 21386 109951867
Faeces discoloured 50.55 16.79 69 615977 33879 109939374
Bronchitis 50.46 16.79 1188 614858 155844 109817409
Blood thyroid stimulating hormone increased 50.44 16.79 5 616041 12296 109960957
Polyuria 50.17 16.79 18 616028 17720 109955533
Pancreatitis 50.10 16.79 310 615736 93223 109880030
Cholecystitis acute 50.07 16.79 13 616033 15769 109957484
Taste disorder 49.98 16.79 571 615475 64816 109908437
Diarrhoea 49.82 16.79 5573 610473 1133932 108839321
Metabolic encephalopathy 49.55 16.79 3 616043 11057 109962196
Kidney infection 49.53 16.79 277 615769 25322 109947931
Anticipatory anxiety 49.52 16.79 47 615999 1209 109972044
Spinal fusion surgery 49.38 16.79 137 615909 9019 109964234
Hyperlipidaemia 49.33 16.79 77 615969 35771 109937482
Glomerular filtration rate decreased 49.32 16.79 53 615993 28903 109944350
Therapy non-responder 49.30 16.79 1186 614860 156121 109817132
Neurological symptom 49.25 16.79 13 616033 15595 109957658
Brain injury 49.16 16.79 8 616038 13468 109959785
Cold sweat 49.08 16.79 31 616015 22000 109951253
Red blood cell sedimentation rate 49.02 16.79 97 615949 5117 109968136
Prostatic specific antigen increased 48.98 16.79 6 616040 12505 109960748
Aortic arteriosclerosis 48.90 16.79 3 616043 10935 109962318
Sputum discoloured 48.89 16.79 50 615996 27895 109945358
Staphylococcal sepsis 48.87 16.79 18 616028 17436 109955817
Drug level decreased 48.87 16.79 21 616025 18527 109954726
Infusion site erythema 48.67 16.79 5 616041 11954 109961299
Device breakage 48.42 16.79 9 616037 13760 109959493
Ecchymosis 48.35 16.79 18 616028 17320 109955933
Partial seizures 48.18 16.79 4 616042 11345 109961908
Systemic lupus erythematosus rash 48.02 16.79 58 615988 1977 109971276
Cardiac tamponade 47.96 16.79 4 616042 11303 109961950
Pneumocystis jirovecii pneumonia 47.95 16.79 104 615942 42631 109930622
Atrioventricular block 47.95 16.79 17 616029 16860 109956393
Pulse absent 47.89 16.79 4 616042 11288 109961965
Hip surgery 47.79 16.79 84 615962 4046 109969207
Drug level below therapeutic 47.20 16.79 5 616041 11668 109961585
Limb deformity 47.04 16.79 79 615967 3667 109969586
Systemic inflammatory response syndrome 47.01 16.79 8 616038 13035 109960218
Embolism 46.98 16.79 16 616030 16273 109956980
Contrast media allergy 46.78 16.79 75 615971 3348 109969905
Immune reconstitution inflammatory syndrome 46.69 16.79 16 616030 16210 109957043
Blood calcium increased 46.62 16.79 21 616025 18019 109955234
Metastases to lymph nodes 46.53 16.79 13 616033 15019 109958234
Adenovirus infection 46.33 16.79 4 616042 10990 109962263
Facial paralysis 46.27 16.79 40 616006 24174 109949079
Dermatitis exfoliative generalised 46.22 16.79 4 616042 10968 109962285
Rotator cuff repair 46.16 16.79 60 615986 2206 109971047
Accidental overdose 45.98 16.79 142 615904 51692 109921561
Product preparation error 45.73 16.79 4 616042 10875 109962378
Dyslipidaemia 45.49 16.79 16 616030 15949 109957304
Scleritis 45.24 16.79 96 615950 5324 109967929
Skin haemorrhage 45.07 16.79 43 616003 24784 109948469
Steroid dependence 44.96 16.79 126 615920 8343 109964910
Aortic stenosis 44.94 16.79 9 616037 13050 109960203
Injection site extravasation 44.84 16.79 3 616043 10166 109963087
Eye pruritus 44.53 16.79 71 615975 32704 109940549
Hiccups 44.02 16.79 9 616037 12860 109960393
Odynophagia 44.01 16.79 12 616034 14089 109959164
Hepatic enzyme abnormal 43.96 16.79 137 615909 9626 109963627
Systemic candida 43.81 16.79 3 616043 9971 109963282
Pneumonia bacterial 43.70 16.79 49 615997 26212 109947041
Epstein-Barr virus infection 43.66 16.79 25 616021 18713 109954540
Arthrodesis 43.40 16.79 64 615982 2654 109970599
Erysipelas 43.38 16.79 10 616036 13148 109960105
Musculoskeletal discomfort 43.12 16.79 251 615795 23287 109949966
Nipple swelling 42.77 16.79 27 616019 370 109972883
Loss of employment 42.63 16.79 71 615975 3273 109969980
Depression 42.57 16.79 2169 613877 315166 109658087
Haemorrhagic stroke 42.54 16.79 12 616034 13777 109959476
Escherichia infection 42.37 16.79 42 616004 23774 109949479
Eyelid ptosis 42.24 16.79 11 616035 13316 109959937
Staphylococcal bacteraemia 42.24 16.79 20 616026 16668 109956585
Periorbital oedema 42.17 16.79 4 616042 10188 109963065
Spondylitis 42.05 16.79 149 615897 11189 109962064
Cerebral haematoma 42.01 16.79 3 616043 9629 109963624
Hospitalisation 41.67 16.79 551 615495 141942 109831311
Failure to thrive 41.53 16.79 12 616034 13562 109959691
Vitamin B12 deficiency 41.46 16.79 4 616042 10051 109963202
Orthopnoea 41.44 16.79 6 616040 11015 109962238
Intracranial pressure increased 41.38 16.79 5 616041 10530 109962723
Hyperreflexia 41.23 16.79 3 616043 9482 109963771
Fine motor skill dysfunction 41.14 16.79 101 615945 6173 109967080
Anal incontinence 41.11 16.79 37 616009 21927 109951326
Necrosis 41.10 16.79 7 616039 11399 109961854
Hypertensive crisis 41.08 16.79 45 616001 24327 109948926
Injection site induration 40.99 16.79 7 616039 11376 109961877
Hypoaesthesia oral 40.60 16.79 22 616024 16980 109956273
Mucous stools 40.49 16.79 106 615940 6741 109966512
Glycosylated haemoglobin increased 40.49 16.79 43 616003 23576 109949677
Chromaturia 40.46 16.79 63 615983 29297 109943956
Amylase increased 40.32 16.79 10 616036 12509 109960744
Skin fissures 40.30 16.79 46 616000 24412 109948841
Apathy 40.28 16.79 20 616026 16219 109957034
Lacrimation increased 40.23 16.79 69 615977 30881 109942372
Candida infection 40.16 16.79 135 615911 47874 109925379
Carotid artery stenosis 40.07 16.79 3 616043 9260 109963993
Pneumonia fungal 40.01 16.79 16 616030 14738 109958515
Renal cyst 39.89 16.79 26 616020 18146 109955107
Dry eye 39.89 16.79 481 615565 55312 109917941
Immune-mediated enterocolitis 39.59 16.79 5 616041 10180 109963073
Bone disorder 39.48 16.79 227 615819 20965 109952288
Peripheral ischaemia 39.38 16.79 7 616039 11051 109962202
Behaviour disorder 39.35 16.79 4 616042 9643 109963610
BK virus infection 39.34 16.79 12 616034 13094 109960159
Blood pressure systolic decreased 39.12 16.79 13 616033 13428 109959825
Hernia 39.07 16.79 213 615833 19287 109953966
Metabolic disorder 38.88 16.79 6 616040 10504 109962749
Carpal tunnel syndrome 38.79 16.79 237 615809 22373 109950880
Antibiotic therapy 38.59 16.79 38 616008 1024 109972229
Escherichia urinary tract infection 38.47 16.79 21 616025 16141 109957112
Synovial fluid analysis 38.38 16.79 60 615986 2621 109970632
Bundle branch block left 38.33 16.79 12 616034 12876 109960377
Hydrocephalus 38.21 16.79 6 616040 10369 109962884
Potentiating drug interaction 38.09 16.79 9 616037 11634 109961619
Adjustment disorder 38.08 16.79 7 616039 10788 109962465
Oral surgery 38.03 16.79 44 616002 1432 109971821
Mental impairment 37.94 16.79 42 616004 22597 109950656
Short stature 37.85 16.79 38 616008 1049 109972204
Arterial occlusive disease 37.75 16.79 19 616027 15289 109957964
Pregnancy 37.71 16.79 443 615603 50624 109922629
Laryngeal oedema 37.68 16.79 5 616041 9802 109963451
Abnormal loss of weight 37.62 16.79 6 616040 10251 109963002
Shoulder arthroplasty 37.46 16.79 70 615976 3537 109969716
Dementia 37.29 16.79 75 615971 31598 109941655
Insurance issue 37.18 16.79 7 616039 10605 109962648
Localised oedema 37.17 16.79 4 616042 9219 109964034
Urticaria 37.13 16.79 2151 613895 316706 109656547
Colectomy 37.08 16.79 78 615968 4300 109968953
Feeling cold 37.07 16.79 84 615962 33903 109939350
Personality change 37.00 16.79 8 616038 10994 109962259
Left ventricular failure 36.87 16.79 9 616037 11380 109961873
Pre-eclampsia 36.86 16.79 3 616043 8647 109964606
Hepatic cirrhosis 36.79 16.79 555 615491 67071 109906182
Breast cancer stage II 36.76 16.79 270 615776 27105 109946148
Multiple sclerosis 36.51 16.79 54 615992 25644 109947609
Appendicitis 36.50 16.79 64 615982 28400 109944853
Skin ulcer 36.46 16.79 527 615519 63118 109910135
Adverse reaction 36.43 16.79 286 615760 29308 109943945
Incontinence 36.25 16.79 24 616022 16611 109956642
Sexual dysfunction 36.23 16.79 3 616043 8527 109964726
Multiple fractures 36.22 16.79 121 615925 8819 109964434
Cytology abnormal 35.95 16.79 23 616023 323 109972930
Iron deficiency 35.94 16.79 30 616016 18446 109954807
Oesophageal candidiasis 35.65 16.79 10 616036 11524 109961729
Thirst 35.58 16.79 41 616005 21666 109951587
SLE arthritis 35.47 16.79 29 616017 608 109972645
Endocarditis 35.45 16.79 15 616031 13356 109959897
Ankle operation 35.18 16.79 41 616005 1345 109971908
Aortic valve incompetence 34.93 16.79 9 616037 10972 109962281
Tongue oedema 34.80 16.79 3 616043 8253 109965000
Dizziness postural 34.74 16.79 19 616027 14590 109958663
Clostridium test positive 34.51 16.79 9 616037 10884 109962369
Endophthalmitis 34.44 16.79 3 616043 8184 109965069
Haemophagocytic lymphohistiocytosis 34.42 16.79 78 615968 31481 109941772
Interstitial lung disease 34.39 16.79 557 615489 138777 109834476
Bacterial sepsis 34.22 16.79 8 616038 10418 109962835
Eye pain 34.13 16.79 153 615893 49946 109923307
Therapeutic response decreased 34.11 16.79 740 615306 95759 109877494
Motor dysfunction 33.99 16.79 52 615994 24354 109948899
Retinal haemorrhage 33.87 16.79 6 616040 9495 109963758
Tenosynovitis stenosans 33.84 16.79 67 615979 3536 109969717
Neutrophilia 33.76 16.79 8 616038 10321 109962932
Bladder cancer 33.62 16.79 38 616008 20254 109952999
Multiple drug therapy 33.54 16.79 3 616043 8011 109965242
Ischaemic cardiomyopathy 33.53 16.79 3 616043 8008 109965245
Escherichia sepsis 33.48 16.79 8 616038 10264 109962989
Paradoxical drug reaction 33.30 16.79 7 616039 9810 109963443
Gout 33.27 16.79 99 615947 36467 109936786
Post procedural complication 33.23 16.79 61 615985 26597 109946656
Sleep disorder due to a general medical condition 33.23 16.79 163 615883 51949 109921304
Bradyphrenia 33.00 16.79 12 616034 11716 109961537
Autoimmune haemolytic anaemia 32.96 16.79 9 616037 10558 109962695
Skin abrasion 32.96 16.79 25 616021 16126 109957127
Decreased immune responsiveness 32.89 16.79 123 615923 9483 109963770
Restless legs syndrome 32.84 16.79 54 615992 24572 109948681
Loose body in joint 32.74 16.79 40 616006 1380 109971873
Gastric ulcer 32.63 16.79 113 615933 39714 109933539
Gastric ulcer haemorrhage 32.63 16.79 8 616038 10086 109963167
Proctitis 32.30 16.79 28 616018 16899 109956354
Tuberculosis 32.21 16.79 189 615857 17585 109955668
Pulmonary function test decreased 32.11 16.79 5 616041 8695 109964558
Red blood cell count decreased 32.02 16.79 225 615821 65698 109907555
Polyomavirus-associated nephropathy 31.94 16.79 4 616042 8197 109965056
Hepatitis C 31.93 16.79 15 616031 12558 109960695
Blood glucose fluctuation 31.90 16.79 3 616043 7695 109965558
Extremity contracture 31.85 16.79 44 616002 1717 109971536
Basal cell carcinoma 31.80 16.79 389 615657 44881 109928372
Nervous system disorder 31.76 16.79 82 615964 31639 109941614
Enteritis 31.60 16.79 36 616010 19120 109954133
Major depression 31.39 16.79 10 616036 10611 109962642
Heavy menstrual bleeding 31.31 16.79 27 616019 16338 109956915
Wrong product administered 31.20 16.79 11 616035 10949 109962304
Neck surgery 31.17 16.79 48 615998 2069 109971184
Localised infection 31.15 16.79 372 615674 42676 109930577
Bunion operation 31.10 16.79 32 616014 910 109972343
Escherichia bacteraemia 31.07 16.79 9 616037 10155 109963098
Gastritis erosive 30.96 16.79 14 616032 11986 109961267
Papule 30.92 16.79 9 616037 10124 109963129
Protein total decreased 30.88 16.79 11 616035 10879 109962374
Affective disorder 30.80 16.79 12 616034 11229 109962024
Euphoric mood 30.55 16.79 6 616040 8821 109964432
Breast cancer metastatic 30.53 16.79 12 616034 11169 109962084
Throat irritation 30.53 16.79 174 615872 53378 109919875
Insomnia 30.32 16.79 2367 613679 358223 109615030
Protein urine present 30.26 16.79 13 616033 11471 109961782
Embolic stroke 30.14 16.79 6 616040 8737 109964516
Metastasis 29.95 16.79 5 616041 8262 109964991
Tachyarrhythmia 29.92 16.79 5 616041 8256 109964997
Neck mass 29.92 16.79 76 615970 4745 109968508
Skin burning sensation 29.91 16.79 47 615999 21778 109951475
Colorectal cancer 29.90 16.79 7 616039 9107 109964146
Dental operation 29.87 16.79 39 616007 1440 109971813
Inflammatory marker increased 29.63 16.79 159 615887 14310 109958943
Portal hypertension 29.62 16.79 6 616040 8631 109964622
Wrist deformity 29.59 16.79 59 615987 3130 109970123
Product administration interrupted 29.41 16.79 13 616033 11279 109961974
Macular degeneration 29.35 16.79 47 615999 21612 109951641
Polydipsia 29.34 16.79 4 616042 7684 109965569
Sinus disorder 29.29 16.79 295 615751 32433 109940820
Eating disorder 29.21 16.79 82 615964 30776 109942477
Pneumatosis intestinalis 29.10 16.79 6 616040 8523 109964730
Bone density abnormal 29.03 16.79 66 615980 3837 109969416
Eye swelling 28.99 16.79 91 615955 32957 109940296
Injection site reaction 28.96 16.79 675 615371 88395 109884858
Hypertransaminasaemia 28.92 16.79 57 615989 24198 109949055
Pustular psoriasis 28.88 16.79 151 615895 13454 109959799
Visual field defect 28.86 16.79 10 616036 10062 109963191
Terminal state 28.81 16.79 83 615963 5584 109967669
Pruritus allergic 28.78 16.79 41 616005 1647 109971606
Personality disorder 28.68 16.79 18 616028 12819 109960434
Nail operation 28.67 16.79 41 616005 1653 109971600
Product storage error 28.65 16.79 48 615998 21680 109951573
Hypersomnia 28.51 16.79 72 615974 27989 109945264
Therapeutic response shortened 28.46 16.79 78 615968 29505 109943748
Bone pain 28.46 16.79 229 615817 64904 109908349
Foetal exposure during pregnancy 28.42 16.79 4 616042 7501 109965752
Incoherent 28.27 16.79 6 616040 8352 109964901
Ulcer haemorrhage 28.27 16.79 219 615827 22352 109950901
Decubitus ulcer 28.24 16.79 36 616010 18200 109955053
Cardiopulmonary failure 28.15 16.79 5 616041 7898 109965355
Transplant dysfunction 28.12 16.79 6 616040 8322 109964931
Apnoea 27.98 16.79 21 616025 13618 109959635
Intermenstrual bleeding 27.96 16.79 3 616043 6931 109966322
Skin hyperpigmentation 27.90 16.79 7 616039 8689 109964564
Dermatitis 27.84 16.79 72 615974 27765 109945488
Wrong technique in device usage process 27.79 16.79 3 616043 6898 109966355
Sinus node dysfunction 27.68 16.79 8 616038 9039 109964214
Rash macular 27.66 16.79 116 615930 38570 109934683
Pruritus 27.61 16.79 2827 613219 578733 109394520
Product residue present 27.51 16.79 65 615981 3876 109969377
Pulmonary thrombosis 27.48 16.79 151 615895 13712 109959541
Gastric haemorrhage 27.25 16.79 29 616017 15886 109957367
Optic neuritis 27.24 16.79 14 616032 11133 109962120
Areflexia 27.11 16.79 3 616043 6766 109966487
Nerve injury 27.10 16.79 125 615921 10588 109962665
Blood thyroid stimulating hormone decreased 27.08 16.79 4 616042 7235 109966018
Venous thrombosis 26.99 16.79 7 616039 8498 109964755
Blood phosphorus decreased 26.98 16.79 5 616041 7660 109965593
Bone cyst 26.88 16.79 61 615985 3542 109969711
Nocturia 26.88 16.79 33 616013 16957 109956296
Coronary artery occlusion 26.72 16.79 29 616017 15743 109957510
Cough 26.66 16.79 2211 613835 459430 109513823
Drooling 26.58 16.79 4 616042 7135 109966118
Colitis ischaemic 26.51 16.79 36 616010 17714 109955539
Infusion site reaction 26.43 16.79 179 615867 17503 109955750
Hunger 26.42 16.79 89 615957 6515 109966738
Hiatus hernia 26.40 16.79 73 615973 27533 109945720
Neuralgia 26.31 16.79 160 615886 48318 109924935
Hyperaesthesia 26.16 16.79 26 616020 14701 109958552
Parathyroid disorder 26.12 16.79 25 616021 650 109972603
Fistula 26.06 16.79 28 616018 15271 109957982
Subdural haemorrhage 26.03 16.79 3 616043 6555 109966698
Joint noise 25.83 16.79 75 615971 5068 109968185
Femur fracture 25.78 16.79 369 615677 44100 109929153
Cardiac disorder 25.71 16.79 286 615760 75994 109897259
Swollen joint count 25.60 16.79 106 615940 8568 109964685
Cytomegalovirus infection reactivation 25.59 16.79 39 616007 18294 109954959
Dermatitis contact 25.53 16.79 24 616022 13929 109959324
Guillain-Barre syndrome 25.51 16.79 14 616032 10730 109962523
Paronychia 25.51 16.79 15 616031 11066 109962187
Sensory disturbance 25.38 16.79 36 616010 17393 109955860
Haemarthrosis 25.33 16.79 5 616041 7324 109965929
Muscle haemorrhage 25.23 16.79 4 616042 6865 109966388
Lung opacity 25.13 16.79 17 616029 11635 109961618
Root canal infection 24.99 16.79 21 616025 458 109972795
Lymphadenopathy 24.96 16.79 231 615815 63604 109909649
Supraventricular extrasystoles 24.95 16.79 7 616039 8066 109965187
Device failure 24.73 16.79 5 616041 7202 109966051
Depressive symptom 24.73 16.79 8 616038 8406 109964847
Clostridial infection 24.73 16.79 3 616043 6299 109966954
Abortion induced 24.70 16.79 7 616039 8012 109965241
Investigation abnormal 24.69 16.79 47 615999 2409 109970844
Delirium 24.68 16.79 568 615478 134457 109838796
Lacunar infarction 24.65 16.79 3 616043 6283 109966970
Porphyria acute 24.52 16.79 184 615862 18596 109954657
Respiratory rate decreased 24.50 16.79 3 616043 6255 109966998
Injection site hypersensitivity 24.48 16.79 47 615999 2424 109970829
Wound dehiscence 24.43 16.79 7 616039 7955 109965298
Dyspnoea at rest 24.42 16.79 8 616038 8338 109964915
Infiltration anaesthesia 24.35 16.79 14 616032 160 109973093
Cardiac dysfunction 24.33 16.79 3 616043 6220 109967033
Clostridium difficile infection 24.31 16.79 180 615866 51949 109921304
Non-small cell lung cancer 24.30 16.79 7 616039 7928 109965325
Hereditary angioedema 24.28 16.79 5 616041 7109 109966144
Blood cholesterol abnormal 24.24 16.79 60 615986 3686 109969567
Joint surgery 24.20 16.79 19 616027 375 109972878
Sneezing 24.07 16.79 94 615952 31890 109941363
Mood altered 23.99 16.79 52 615994 21323 109951930
Latent tuberculosis 23.96 16.79 62 615984 3915 109969338
Sleep terror 23.94 16.79 4 616042 6606 109966647
Facial paresis 23.77 16.79 3 616043 6110 109967143
Suspected COVID-19 23.72 16.79 57 615989 3436 109969817
Papilloedema 23.70 16.79 6 616040 7403 109965850
Therapeutic product effect variable 23.69 16.79 49 615997 2669 109970584
Frustration tolerance decreased 23.68 16.79 104 615942 8627 109964626
Temperature regulation disorder 23.64 16.79 137 615909 12689 109960564
Tension headache 23.62 16.79 12 616034 9606 109963647
Cataract 23.62 16.79 595 615451 78890 109894363
Macular oedema 23.56 16.79 5 616041 6961 109966292
Catarrh 23.53 16.79 92 615954 7243 109966010
Staphylococcus test positive 23.52 16.79 6 616040 7364 109965889
Discontinued product administered 23.51 16.79 12 616034 106 109973147
Hepatic lesion 23.38 16.79 9 616037 8484 109964769
Burns second degree 23.21 16.79 95 615951 7638 109965615
Drug dependence 23.19 16.79 173 615873 49847 109923406
Pelvic pain 23.14 16.79 33 616013 15909 109957344
Rhinovirus infection 23.11 16.79 19 616027 11770 109961483
Subileus 23.09 16.79 4 616042 6433 109966820
Skin discolouration 23.04 16.79 169 615877 48877 109924376
Blindness 23.03 16.79 114 615932 36245 109937008
Dysaesthesia 22.98 16.79 5 616041 6842 109966411
Exercise tolerance decreased 22.98 16.79 20 616026 12047 109961206
Nasal oedema 22.95 16.79 5 616041 6834 109966419
Paralysis 22.93 16.79 32 616014 15568 109957685
Rash papular 22.93 16.79 78 615968 27561 109945692
Bradykinesia 22.92 16.79 16 616030 10772 109962481
Subcutaneous drug absorption impaired 22.92 16.79 94 615952 7565 109965688
Anaphylactoid reaction 22.88 16.79 5 616041 6821 109966432
Nerve block 22.86 16.79 25 616021 764 109972489
Diverticulum intestinal 22.83 16.79 19 616027 11700 109961553
Rheumatoid factor increased 22.83 16.79 46 616000 2459 109970794
Extrasystoles 22.59 16.79 9 616037 8309 109964944
Spinal cord compression 22.52 16.79 7 616039 7545 109965708
Overlap syndrome 22.40 16.79 105 615941 8954 109964299
Bone swelling 22.33 16.79 38 616008 1783 109971470
Haemorrhagic diathesis 22.31 16.79 7 616039 7501 109965752
Thrombotic thrombocytopenic purpura 22.29 16.79 6 616040 7105 109966148
Choking 22.21 16.79 31 616015 15079 109958174
Organising pneumonia 22.18 16.79 28 616018 14215 109959038
Peripheral arterial occlusive disease 22.17 16.79 12 616034 9268 109963985
Faecal calprotectin increased 22.15 16.79 85 615961 6634 109966619
Autonomic nervous system imbalance 22.08 16.79 3 616043 5777 109967476
Portal vein thrombosis 22.04 16.79 6 616040 7052 109966201
Occult blood positive 22.02 16.79 7 616039 7438 109965815
Fracture delayed union 21.97 16.79 42 616004 2159 109971094
Nervousness 21.95 16.79 118 615928 36733 109936520
Conjunctival haemorrhage 21.95 16.79 5 616041 6628 109966625
Cytomegalovirus test positive 21.94 16.79 6 616040 7030 109966223
Nerve compression 21.87 16.79 121 615925 11016 109962237
Neuritis 21.81 16.79 7 616039 7392 109965861
Tearfulness 21.79 16.79 7 616039 7388 109965865
Nightmare 21.76 16.79 127 615919 38736 109934517
Joint ankylosis 21.74 16.79 45 616001 2452 109970801
Multiple-drug resistance 21.69 16.79 25 616021 13210 109960043
Brain death 21.66 16.79 5 616041 6568 109966685
Lung consolidation 21.66 16.79 16 616030 10460 109962793
Burning sensation 21.58 16.79 264 615782 68948 109904305
Pulmonary tuberculosis 21.57 16.79 12 616034 9127 109964126
Lung neoplasm 21.51 16.79 9 616037 8067 109965186
Femoral neck fracture 21.41 16.79 23 616023 12544 109960709
Anaemia macrocytic 21.36 16.79 7 616039 7296 109965957
Soft tissue disorder 21.30 16.79 55 615991 3469 109969784
Ocular icterus 21.19 16.79 4 616042 6049 109967204
Intestinal perforation 21.07 16.79 54 615992 20890 109952363
Diffuse large B-cell lymphoma 21.07 16.79 35 616011 15863 109957390
Therapy change 21.01 16.79 15 616031 9982 109963271
Ear injury 20.97 16.79 17 616029 352 109972901
Necrotising fasciitis 20.97 16.79 8 616038 7583 109965670
Tendonitis 20.94 16.79 230 615816 25853 109947400
Breakthrough pain 20.82 16.79 34 616012 1542 109971711
Pseudomembranous colitis 20.79 16.79 5 616041 6386 109966867
Brain abscess 20.70 16.79 6 616040 6768 109966485
Livedo reticularis 20.70 16.79 3 616043 5503 109967750
Blood chloride increased 20.70 16.79 5 616041 6367 109966886
Overwork 20.69 16.79 9 616037 53 109973200
Skin plaque 20.60 16.79 24 616022 12621 109960632
Amenorrhoea 20.55 16.79 13 616033 9218 109964035
Iron deficiency anaemia 20.54 16.79 98 615948 31461 109941792
Blood glucose abnormal 20.52 16.79 25 616021 12891 109960362
Nephropathy 20.43 16.79 27 616019 13440 109959813
Abdominal distension 20.40 16.79 783 615263 174320 109798933
Synovial disorder 20.35 16.79 49 615997 2958 109970295
Nodal osteoarthritis 20.34 16.79 25 616021 868 109972385
Procedural haemorrhage 20.30 16.79 3 616043 5424 109967829
Movement disorder 20.28 16.79 300 615746 36104 109937149
Lymphocytosis 20.22 16.79 3 616043 5408 109967845
Rash pustular 20.21 16.79 25 616021 12804 109960449
Product complaint 20.20 16.79 29 616017 13943 109959310
Respiratory tract infection 20.18 16.79 279 615767 71338 109901915
Autoimmune hepatitis 20.18 16.79 32 616014 14772 109958481
Tooth abscess 20.14 16.79 176 615870 18613 109954640
Erythema nodosum 20.14 16.79 6 616040 6647 109966606
Pneumonia klebsiella 20.04 16.79 6 616040 6626 109966627
Skin swelling 19.97 16.79 10 616036 8070 109965183
Intervertebral disc space narrowing 19.95 16.79 37 616009 1859 109971394
Fluid intake reduced 19.91 16.79 7 616039 6979 109966274
Wound complication 19.77 16.79 5 616041 6172 109967081
Haemorrhoids 19.75 16.79 117 615929 35555 109937698
Physical disability 19.71 16.79 68 615978 5038 109968215
Glaucoma 19.69 16.79 202 615844 22315 109950938
Muscle atrophy 19.67 16.79 27 616019 13227 109960026
Nipple pain 19.59 16.79 28 616018 1128 109972125
Therapeutic reaction time decreased 19.56 16.79 3 616043 5276 109967977
Pulmonary sepsis 19.56 16.79 3 616043 5275 109967978
Nephritis 19.52 16.79 5 616041 6121 109967132
Bacterial test positive 19.52 16.79 10 616036 7967 109965286
Urine analysis abnormal 19.50 16.79 7 616039 6890 109966363
Viral upper respiratory tract infection 19.45 16.79 110 615936 10098 109963155
COVID-19 pneumonia 19.43 16.79 124 615922 37019 109936234
Micturition urgency 19.30 16.79 50 615996 19270 109953983
Hepatocellular carcinoma 19.27 16.79 16 616030 9864 109963389
Normocytic anaemia 19.27 16.79 6 616040 6461 109966792
Transplant failure 19.15 16.79 4 616042 5631 109967622
Pulmonary congestion 19.09 16.79 98 615948 30868 109942385
Urinary tract obstruction 19.05 16.79 3 616043 5174 109968079
Skin tightness 19.04 16.79 4 616042 5609 109967644
Somnambulism 18.98 16.79 6 616040 6399 109966854
Abdominal abscess 18.85 16.79 13 616033 8806 109964447
Blood creatinine decreased 18.83 16.79 14 616032 9123 109964130
Neutrophil count abnormal 18.83 16.79 3 616043 5129 109968124
Lumbar vertebral fracture 18.80 16.79 14 616032 9117 109964136
Ageusia 18.75 16.79 52 615994 19593 109953660
Rosacea 18.73 16.79 68 615978 5168 109968085
Oesophageal carcinoma 18.64 16.79 22 616024 11502 109961751
Blood sodium increased 18.61 16.79 4 616042 5519 109967734
Gastric polyps 18.61 16.79 4 616042 5519 109967734
Hepatitis toxic 18.55 16.79 5 616041 5916 109967337
Intraventricular haemorrhage 18.53 16.79 4 616042 5503 109967750
Carpal tunnel decompression 18.37 16.79 24 616022 887 109972366
Gastrointestinal necrosis 18.34 16.79 7 616039 6633 109966620
Furuncle 18.26 16.79 96 615950 8572 109964681
Trismus 18.14 16.79 7 616039 6589 109966664
Immobile 18.12 16.79 88 615958 7614 109965639
Iridocyclitis 18.05 16.79 4 616042 5404 109967849
Pneumonia pneumococcal 18.00 16.79 3 616043 4962 109968291
Blood folate decreased 17.94 16.79 40 616006 2295 109970958
Fibrin D dimer increased 17.93 16.79 17 616029 9828 109963425
Energy increased 17.90 16.79 53 615993 3621 109969632
Acute febrile neutrophilic dermatosis 17.85 16.79 3 616043 4933 109968320
Alcohol abuse 17.82 16.79 3 616043 4926 109968327
Respiration abnormal 17.79 16.79 17 616029 9792 109963461
Obstruction 17.76 16.79 5 616041 5747 109967506
Sputum increased 17.75 16.79 5 616041 5746 109967507
Tinnitus 17.73 16.79 234 615812 60306 109912947
Allergic oedema 17.62 16.79 24 616022 924 109972329
Lymphocyte percentage decreased 17.58 16.79 4 616042 5306 109967947
Pneumonia staphylococcal 17.54 16.79 6 616040 6085 109967168
Anal fistula 17.44 16.79 13 616033 8460 109964793
Large intestine perforation 17.41 16.79 42 616004 16587 109956666
Cyst 17.41 16.79 154 615892 16342 109956911
Steroid diabetes 17.31 16.79 4 616042 5250 109968003
Aphthous ulcer 17.29 16.79 60 615986 21076 109952177
Defaecation urgency 17.16 16.79 95 615951 8652 109964601
Oxygen saturation abnormal 17.09 16.79 5 616041 5606 109967647
Metastases to peritoneum 17.09 16.79 5 616041 5605 109967648
Laryngeal pain 17.01 16.79 6 616040 5969 109967284
Renal cancer 16.99 16.79 29 616017 13005 109960248
Myelopathy 16.93 16.79 5 616041 5571 109967682
Anal fissure 16.93 16.79 18 616028 9863 109963390
Gallbladder adenocarcinoma 16.91 16.79 10 616036 121 109973132
Abscess 16.90 16.79 87 615959 27382 109945871
Meningitis aseptic 16.88 16.79 18 616028 9852 109963401
Elbow operation 16.88 16.79 17 616029 471 109972782
Carotid artery occlusion 16.86 16.79 17 616029 9548 109963705
Acne cystic 16.81 16.79 23 616023 889 109972364
Thoracic vertebral fracture 16.81 16.79 8 616038 6647 109966606

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AF01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Janus-associated kinase (JAK) inhibitors
MeSH PA D000075242 Janus Kinase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA MoA N0000190857 Janus Kinase Inhibitors
FDA EPC N0000190858 Janus Kinase Inhibitor
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:76617 EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:70868 antileishmanial agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

L04AF Janus-associated kinase (JAK) inhibitors 7 drugs
baricitinibdeucravacitinibdeuruxolitinibfilgotinibpeficitinibritlecitinibupadacitinib

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

DiseaseRelationSNOMED_IDDOID
Ulcerative colitis indication 64766004 DOID:8577
Rheumatoid arthritis indication 69896004 DOID:7148
Psoriatic arthritis indication 156370009 DOID:9008
Juvenile psoriatic arthritis indication 239802003
Juvenile idiopathic arthritis, extended oligoarthritis indication 410800006
Polyarticular juvenile idiopathic arthritis indication 16044800000000000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.27 acidic
pKa2 6.48 Basic
pKa3 0.91 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING RHEUMATOID ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 AND 87-98
EQ 11MG BASE XELJANZ XR PFIZER N208246 Feb. 23, 2016 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ULCERATIVE COLITIS, BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ANKYLOSING SPONDYLITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-43, 45, 47, 49, 50, 54, 59, 63, 68-71, 73, 77, 82-84, AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING PSORIATIC ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 8, 15-20, 27-31, 34-44, 46, 48, 50, 53, 59, 62, 68-71, 73, 76, 82-84, AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING RHEUMATOID ARTHRITIS BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 2, 8, 9, 15-21, 27-31, 34-43, 50, 51, 59, 60, 68-71, 73, 74, 82-84 AND 87-98
EQ 22MG BASE XELJANZ XR PFIZER N208246 Dec. 12, 2019 RX TABLET, EXTENDED RELEASE ORAL 11253523 March 14, 2034 A METHOD OF TREATING ULCERATIVE COLITIS, BY ADMINISTERING THE FORMULATION OF TOFACITINIB OF CLAIMS 1, 3, 8, 10, 15-20, 22, 27-31, 34-43, 50, 52, 59, 61, 68-71, 73, 75, 82-84 AND 87-98

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 5MG BASE XELJANZ PF PRISM CV N203214 Nov. 6, 2012 RX TABLET ORAL Feb. 21, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 1MG BASE/ML XELJANZ PFIZER N213082 Sept. 25, 2020 RX SOLUTION ORAL Feb. 21, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 5MG BASE XELJANZ PF PRISM CV N203214 Nov. 6, 2012 RX TABLET ORAL Aug. 21, 2028 PEDIATRIC EXCLUSIVITY
EQ 1MG BASE/ML XELJANZ PFIZER N213082 Sept. 25, 2020 RX SOLUTION ORAL Aug. 21, 2028 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
JAK1/TYK2 Kinase INHIBITOR IC50 7.46 CHEMBL CHEMBL
JAK2/TYK2 Kinase INHIBITOR IC50 6.64 CHEMBL CHEMBL
JAK2/JAK1 Kinase INHIBITOR IC50 6.39 DRUG LABEL DRUG LABEL
JAK3/JAK1 Kinase INHIBITOR IC50 7.25 DRUG LABEL DRUG LABEL
Tyrosine-protein kinase ABL1 Kinase Kd 5.66 CHEMBL
Tyrosine-protein kinase Lck Kinase Kd 6.34 CHEMBL
Tyrosine-protein kinase Fyn Kinase Kd 5.96 CHEMBL
Proto-oncogene tyrosine-protein kinase receptor Ret Kinase Kd 5.48 CHEMBL
Calcium/calmodulin-dependent protein kinase type 1 Kinase Kd 5.92 CHEMBL
Rho-associated protein kinase 1 Kinase Kd 6.33 CHEMBL
Tyrosine-protein kinase JAK1 Kinase INHIBITOR Ki 9.17 CHEMBL
Protein kinase C delta type Kinase Kd 5.70 CHEMBL
Tyrosine-protein kinase JAK2 Kinase INHIBITOR Kd 9.24 CHEMBL
Rho-associated protein kinase 2 Kinase Kd 6.38 CHEMBL
Protein kinase C alpha type Kinase Kd 4.55 CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit delta Kinase Kd 5.57 CHEMBL
Serine/threonine-protein kinase MARK2 Kinase Kd 5.18 CHEMBL
Ribosomal protein S6 kinase alpha-2 Kinase Kd 6.22 CHEMBL
Calcium/calmodulin-dependent protein kinase type II subunit alpha Kinase Kd 5.46 CHEMBL
Activated CDC42 kinase 1 Kinase Kd 5.97 CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 2 Kinase Kd 5.80 CHEMBL
MAP/microtubule affinity-regulating kinase 3 Kinase Kd 4.97 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 1 Kinase Kd 6.37 CHEMBL
Serine/threonine-protein kinase N2 Kinase Kd 5.92 CHEMBL
Serine/threonine-protein kinase DCLK3 Kinase Kd 8.35 CHEMBL
Serine/threonine-protein kinase 3 Kinase Kd 5.37 CHEMBL
Ribosomal protein S6 kinase alpha-6 Kinase Kd 6.27 CHEMBL
NUAK family SNF1-like kinase 2 Kinase Kd 6.62 CHEMBL
Non-receptor tyrosine-protein kinase TNK1 Kinase Kd 6.92 CHEMBL
Non-receptor tyrosine-protein kinase TYK2 Kinase INHIBITOR Ki 8.36 CHEMBL
Serine/threonine-protein kinase N1 Kinase Kd 6.77 CHEMBL
Aurora kinase B Kinase Kd 6.28 CHEMBL
Serine/threonine-protein kinase DCLK1 Kinase Kd 5.17 CHEMBL
Ribosomal protein S6 kinase alpha-1 Kinase Kd 5.85 CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 2 Kinase Kd 5.32 CHEMBL
G protein-coupled receptor kinase 7 Kinase Kd 5.37 CHEMBL
Serine/threonine-protein kinase ULK3 Kinase Kd 5.19 CHEMBL
Leucine-rich repeat serine/threonine-protein kinase 2 Kinase Kd 6.26 CHEMBL
JAK1/JAK2/TYK2 Kinase INHIBITOR IC50 7.12 CHEMBL
Myotonin-protein kinase Kinase Kd 5.92 CHEMBL
BMP-2-inducible protein kinase Kinase Kd 5.15 CHEMBL
Calcium/calmodulin-dependent protein kinase type 1D Kinase Kd 5.80 CHEMBL
Tyrosine-protein kinase JAK3 Kinase INHIBITOR IC50 8.48 WOMBAT-PK
Tyrosine-protein kinase JAK3 Kinase IC50 7.32 CHEMBL
Tyrosine-protein kinase JAK2 Kinase IC50 5.69 CHEMBL
Serine/threonine-protein kinase PknB Kinase Kd 5.70 CHEMBL
Tyrosine-protein kinase JAK3 Kinase IC50 5.92 CHEMBL
Tyrosine-protein kinase JAK2 Kinase IC50 5.74 CHEMBL

External reference:

IDSource
D09783 KEGG_DRUG
4031786 VUID
N0000186059 NUI
4031786 VANDF
CHEBI:71200 CHEBI
CHEMBL221959 ChEMBL_ID
CHEMBL459769 ChEMBL_ID
CHEMBL2103743 ChEMBL_ID
C479163 MESH_SUPPLEMENTAL_RECORD_UI
5677 IUPHAR_LIGAND_ID
540737-29-9 SECONDARY_CAS_RN
DB08895 DRUGBANK_ID
87LA6FU830 UNII
1357536 RXNORM
194456 MMSL
28976 MMSL
31571 MMSL
d07925 MMSL
014743 NDDF
014744 NDDF
704313003 SNOMEDCT_US
704314009 SNOMEDCT_US
704316006 SNOMEDCT_US
C2930696 UMLSCUI
MI1 PDB_CHEM_ID
9298 INN_ID
9926791 PUBCHEM_CID
87LA6FU830 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
tofacitinib solution HUMAN PRESCRIPTION DRUG LABEL 1 0054-0821 SOLUTION 1 mg ORAL ANDA 34 sections
XELJANZXR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0501 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZXR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0501 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL NDA 35 sections
XELJANZXR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0502 TABLET, FILM COATED, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZXR HUMAN PRESCRIPTION DRUG LABEL 1 0069-0502 TABLET, FILM COATED, EXTENDED RELEASE 22 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1001 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1001 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1002 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1002 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1029 SOLUTION 1 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 0069-1029 SOLUTION 1 mg ORAL NDA 35 sections
TOFACITINIB CITRATE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1811 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL ANDA 29 sections
Tofacitinib Human Prescription Drug Label 1 27241-270 TABLET, EXTENDED RELEASE 11 mg ORAL ANDA 29 sections
Tofacitinib Human Prescription Drug Label 1 33342-541 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Tofacitinib Human Prescription Drug Label 1 33342-542 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
TOFACITINIB HUMAN PRESCRIPTION DRUG LABEL 1 42571-268 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
TOFACITINIB HUMAN PRESCRIPTION DRUG LABEL 1 42571-377 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Tofacitinib Human Prescription Drug Label 1 42799-970 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL ANDA 29 sections
TOFACITINIB CITRATE Human Prescription Drug Label 1 50228-567 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL ANDA 29 sections
Tofacitinib HUMAN PRESCRIPTION DRUG LABEL 1 51991-329 TABLET 5 mg ORAL ANDA 34 sections
Tofacitinib HUMAN PRESCRIPTION DRUG LABEL 1 51991-963 TABLET 10 mg ORAL ANDA 34 sections
TOFACITINIB Human Prescription Drug Label 1 59651-459 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
TOFACITINIB Human Prescription Drug Label 1 59651-460 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
TOFACITINIB Human Prescription Drug Label 1 59651-685 TABLET, EXTENDED RELEASE 11 mg ORAL ANDA 29 sections
Tofacitinib HUMAN PRESCRIPTION DRUG LABEL 1 60505-4858 TABLET, FILM COATED, EXTENDED RELEASE 11 mg ORAL ANDA 30 sections
Tofacitinib HUMAN PRESCRIPTION DRUG LABEL 1 60505-6263 TABLET, FILM COATED 5 mg ORAL ANDA 29 sections
Tofacitinib HUMAN PRESCRIPTION DRUG LABEL 1 60505-6264 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-012 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-012 TABLET, FILM COATED 5 mg ORAL NDA 35 sections
XELJANZ HUMAN PRESCRIPTION DRUG LABEL 1 63539-016 TABLET, FILM COATED 10 mg ORAL NDA 35 sections