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

Stem definitionDrug idCAS RN
human origin 4967 476181-74-5

Description:

MoleculeDescription

Synonyms:

  • golimumab
  • simponi
  • CNTO 148
  • CNTO-148
Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
1.66 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
April 24, 2009 FDA CENTOCOR ORTHO BIOTECH INC
Oct. 1, 2009 EMA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigus 3132.30 22.71 6023 485777 320841 89815806
Contraindicated product administered 3051.39 22.71 5886 485914 314253 89822394
Glossodynia 3024.02 22.71 5881 485919 315898 89820749
Systemic lupus erythematosus 2879.95 22.71 6174 485626 355722 89780925
Hand deformity 2542.68 22.71 5216 486584 291146 89845501
Swelling 2355.05 22.71 6246 485554 412812 89723835
Arthropathy 2249.09 22.71 5645 486155 360597 89776050
Wound 2220.12 22.71 5003 486797 297977 89838670
Synovitis 2212.20 22.71 5259 486541 324493 89812154
Joint swelling 2167.63 22.71 6818 484982 496482 89640165
Therapeutic product effect decreased 2114.83 22.71 4656 487144 272915 89863732
Alopecia 2096.46 22.71 6668 485132 488403 89648244
Drug intolerance 1952.51 22.71 6092 485708 441499 89695148
Abdominal discomfort 1866.26 22.71 6258 485542 471070 89665577
Anti-cyclic citrullinated peptide antibody positive 1851.46 22.71 4011 487789 232422 89904225
Pericarditis 1813.28 22.71 4311 487489 265840 89870807
Treatment failure 1566.69 22.71 4392 487408 299536 89837111
Discomfort 1539.15 22.71 4090 487710 270245 89866402
Anaemia 1519.70 22.71 101 491699 352701 89783946
Lower respiratory tract infection 1516.98 22.71 3845 487955 246814 89889833
Folliculitis 1393.99 22.71 3283 488517 201070 89935577
Hypersensitivity 1335.09 22.71 5437 486363 449240 89687407
Irritable bowel syndrome 1333.53 22.71 3257 488543 204191 89932456
Toxicity to various agents 1332.01 22.71 53 491747 287793 89848854
Helicobacter infection 1325.90 22.71 3435 488365 223415 89913232
Acute kidney injury 1322.15 22.71 112 491688 320275 89816372
Muscle injury 1301.68 22.71 2926 488874 173728 89962919
Drug interaction 1299.54 22.71 45 491755 276408 89860239
Rheumatoid factor positive 1280.28 22.71 2857 488943 168793 89967854
Duodenal ulcer perforation 1273.97 22.71 3332 488468 217956 89918691
Death 1272.68 22.71 445 491355 456106 89680541
Drug ineffective 1241.60 22.71 12181 479619 1372117 88764530
Impaired healing 1163.51 22.71 3341 488459 230858 89905789
Hypotension 1145.85 22.71 194 491606 325203 89811444
Hepatic enzyme increased 1131.33 22.71 4405 487395 356331 89780316
Blister 1121.31 22.71 3484 488316 251514 89885133
Constipation 1116.79 22.71 113 491687 280282 89856365
Ill-defined disorder 1106.13 22.71 2825 488975 182066 89954581
Product use issue 1072.24 22.71 4075 487725 325844 89810803
Neutropenia 1041.74 22.71 41 491759 224863 89911784
Sleep disorder due to general medical condition, insomnia type 1034.32 22.71 2208 489592 126486 90010161
Infusion related reaction 1027.05 22.71 4729 487071 412051 89724596
Psoriatic arthropathy 867.62 22.71 2969 488831 225366 89911281
Rheumatic fever 859.56 22.71 2285 489515 150836 89985811
Febrile neutropenia 824.24 22.71 6 491794 158343 89978304
Cough 801.11 22.71 507 491293 368455 89768192
Dehydration 793.55 22.71 71 491729 194376 89942271
Maternal exposure during pregnancy 774.22 22.71 3930 487870 356133 89780514
Infection 772.88 22.71 3944 487856 358150 89778497
Stomatitis 766.83 22.71 3237 488563 271461 89865186
Musculoskeletal stiffness 755.87 22.71 3400 488400 293132 89843515
Pain 755.78 22.71 8486 483314 987855 89148792
Type 2 diabetes mellitus 740.02 22.71 2606 489194 200638 89936009
Fall 712.76 22.71 943 490857 480867 89655780
Peripheral swelling 702.90 22.71 4232 487568 408874 89727773
Swollen joint count increased 674.74 22.71 1709 490091 109497 90027150
Thrombocytopenia 670.35 22.71 155 491645 208570 89928077
Device deployment issue 664.72 22.71 383 491417 4526 90132121
Sinusitis 654.03 22.71 3623 488177 339465 89797182
Gastrointestinal disorder 649.31 22.71 2937 488863 253750 89882897
Hyponatraemia 644.37 22.71 17 491783 133521 90003126
Disease progression 642.22 22.71 56 491744 156559 89980088
Tremor 638.48 22.71 51 491749 153122 89983525
Mobility decreased 623.83 22.71 2855 488945 247879 89888768
Somnolence 609.57 22.71 188 491612 208896 89927751
Rash 608.46 22.71 6794 485006 789306 89347341
Nausea 588.69 22.71 3578 488222 1106738 89029909
Blood cholesterol increased 579.18 22.71 2450 489350 205562 89931085
Seizure 548.02 22.71 86 491714 152543 89984104
Liver injury 539.25 22.71 2090 489710 168477 89968170
Haemoglobin decreased 510.65 22.71 125 491675 161831 89974816
Chest discomfort 505.84 22.71 74 491726 138291 89998356
Sepsis 502.42 22.71 174 491626 179640 89957007
C-reactive protein abnormal 500.25 22.71 1676 490124 125753 90010894
Injection site pain 499.46 22.71 160 491640 173539 89963108
Fibromyalgia 498.30 22.71 2329 489471 203940 89932707
Renal failure 498.10 22.71 62 491738 130945 90005702
Platelet count decreased 496.71 22.71 75 491725 136894 89999753
Hyperhidrosis 493.46 22.71 75 491725 136230 90000417
Pancytopenia 484.98 22.71 46 491754 120217 90016430
Respiratory failure 483.68 22.71 43 491757 118375 90018272
Injury 465.51 22.71 2213 489587 195136 89941511
White blood cell count decreased 457.83 22.71 167 491633 166942 89969705
Feeling abnormal 455.01 22.71 169 491631 167066 89969581
Cardiac failure 438.58 22.71 43 491757 109453 90027194
Oxygen saturation decreased 433.70 22.71 41 491759 107442 90029205
Neuropathy peripheral 431.24 22.71 106 491694 136864 89999783
Knee arthroplasty 431.14 22.71 1206 490594 81976 90054671
Arthralgia 427.81 22.71 6253 485547 772269 89364378
Hip arthroplasty 427.02 22.71 1137 490663 75071 90061576
Balance disorder 413.98 22.71 29 491771 97051 90039596
Dysphagia 412.84 22.71 59 491741 112219 90024428
Blood pressure increased 410.07 22.71 284 491516 196933 89939714
Bradycardia 399.58 22.71 12 491788 83835 90052812
Pulmonary embolism 398.91 22.71 108 491692 130712 90005935
Myalgia 398.83 22.71 227 491573 174898 89961749
Vision blurred 398.51 22.71 61 491739 110232 90026415
Cardiac failure congestive 389.46 22.71 41 491759 98653 90037994
Erythema 387.49 22.71 403 491397 228843 89907804
General physical health deterioration 383.83 22.71 3262 488538 351853 89784794
Gastrointestinal haemorrhage 381.83 22.71 28 491772 90220 90046427
Night sweats 376.44 22.71 1540 490260 127226 90009421
Palpitations 372.21 22.71 138 491662 136590 90000057
Suicide attempt 369.84 22.71 8 491792 75391 90061256
Nasopharyngitis 369.58 22.71 3601 488199 403503 89733144
Grip strength decreased 362.70 22.71 1217 490583 91359 90045288
Hypoxia 350.04 22.71 9 491791 72390 90064257
Joint range of motion decreased 349.25 22.71 1561 490239 134082 90002565
Diarrhoea 348.69 22.71 3339 488461 935851 89200796
Coma 347.55 22.71 10 491790 72622 90064025
Inflammation 347.08 22.71 1897 489903 176695 89959952
Depressed level of consciousness 344.73 22.71 11 491789 72773 90063874
Renal impairment 331.03 22.71 82 491718 105339 90031308
Hypoglycaemia 329.24 22.71 11 491789 69837 90066810
Cerebrovascular accident 329.07 22.71 129 491671 123404 90013243
Chills 325.82 22.71 154 491646 131827 90004820
Agitation 325.70 22.71 8 491792 67090 90069557
Cardio-respiratory arrest 325.54 22.71 3 491797 63137 90073510
Heart rate increased 320.97 22.71 106 491694 112796 90023851
Facet joint syndrome 320.09 22.71 1217 490583 97172 90039475
Neutrophil count decreased 315.03 22.71 18 491782 71514 90065133
Intentional product use issue 312.55 22.71 2132 489668 214760 89921887
Urinary tract infection 310.20 22.71 755 491045 304877 89831770
Blood glucose increased 309.12 22.71 69 491731 95177 90041470
Overdose 308.53 22.71 242 491558 157467 89979180
Sciatica 307.83 22.71 1227 490573 100155 90036492
Sleep disorder 306.72 22.71 1982 489818 196048 89940599
Lip dry 306.67 22.71 1222 490578 99733 90036914
Pulmonary fibrosis 305.75 22.71 1275 490525 106228 90030419
Epistaxis 305.43 22.71 48 491752 85077 90051570
Multiple organ dysfunction syndrome 304.67 22.71 16 491784 68320 90068327
Dyspnoea exertional 304.18 22.71 23 491777 72265 90064382
Injection site erythema 299.01 22.71 82 491718 98420 90038227
Adverse event 297.54 22.71 1345 490455 116073 90020574
Blood pressure decreased 288.21 22.71 34 491766 74861 90061786
Cognitive disorder 283.96 22.71 25 491775 69382 90067265
Hypercholesterolaemia 280.22 22.71 1188 490612 99704 90036943
Dry skin 279.46 22.71 67 491733 88006 90048641
Hypokalaemia 278.94 22.71 184 491616 130932 90005715
Red blood cell sedimentation rate increased 278.91 22.71 1034 490766 81561 90055086
Skin exfoliation 276.39 22.71 25 491775 67888 90068759
Contusion 276.13 22.71 2317 489483 248899 89887748
Blood creatinine increased 273.13 22.71 104 491696 101282 90035365
Flushing 271.75 22.71 72 491728 88419 90048228
Tachycardia 271.10 22.71 273 491527 157400 89979247
Oropharyngeal pain 269.91 22.71 144 491656 115043 90021604
Foot deformity 268.00 22.71 822 490978 58829 90077818
Atrial fibrillation 267.74 22.71 200 491600 133411 90003236
Mucosal inflammation 264.98 22.71 11 491789 57614 90079033
Rheumatoid arthritis 264.04 22.71 3069 488731 359545 89777102
Dysarthria 262.53 22.71 7 491793 54475 90082172
Bone erosion 261.31 22.71 755 491045 52266 90084381
Weight decreased 256.69 22.71 1124 490676 378786 89757861
Pleural effusion 255.16 22.71 145 491655 111846 90024801
Peripheral venous disease 252.60 22.71 1013 490787 82908 90053739
Hyperglycaemia 251.60 22.71 5 491795 50965 90085682
Chronic obstructive pulmonary disease 248.80 22.71 49 491751 73780 90062867
Dyspnoea 243.92 22.71 3343 488457 877612 89259035
Chronic kidney disease 243.54 22.71 6 491794 50185 90086462
Weight increased 243.10 22.71 3393 488407 414534 89722113
Myelosuppression 240.64 22.71 12 491788 53579 90083068
Hallucination 239.35 22.71 36 491764 65923 90070724
Suicidal ideation 236.67 22.71 55 491745 73800 90062847
Angioedema 236.36 22.71 35 491765 64841 90071806
Deep vein thrombosis postoperative 236.19 22.71 883 490917 69926 90066721
International normalised ratio increased 236.18 22.71 4 491796 47312 90089335
Encephalopathy 235.80 22.71 3 491797 46441 90090206
Syncope 234.64 22.71 224 491576 132439 90004208
Dizziness 233.66 22.71 2059 489741 587225 89549422
Wound infection 227.71 22.71 1161 490639 105241 90031406
Lower limb fracture 226.81 22.71 989 490811 84024 90052623
Rash erythematous 226.25 22.71 40 491760 65064 90071583
Neoplasm progression 225.30 22.71 3 491797 44483 90092164
Anxiety 222.49 22.71 895 490905 308877 89827770
Bone pain 222.25 22.71 35 491765 61948 90074699
Hot flush 221.63 22.71 30 491770 59458 90077189
Blood bilirubin increased 219.85 22.71 3 491797 43467 90093180
Pulmonary oedema 218.25 22.71 37 491763 62043 90074604
Dysgeusia 217.56 22.71 18 491782 52542 90084105
Ascites 216.58 22.71 10 491790 47730 90088917
Gait inability 215.86 22.71 1448 490352 145008 89991639
Blood alkaline phosphatase increased 215.14 22.71 11 491789 48068 90088579
Disorientation 215.10 22.71 5 491795 44109 90092538
Dislocation of vertebra 214.96 22.71 731 491069 55237 90081410
Intentional product misuse 214.39 22.71 109 491691 89495 90047152
Confusional state 213.95 22.71 3109 488691 383096 89753551
Disturbance in attention 213.29 22.71 10 491790 47099 90089548
Wrong technique in product usage process 210.90 22.71 63 491737 71508 90065139
Leukopenia 210.62 22.71 144 491656 100566 90036081
Adjustment disorder with depressed mood 209.03 22.71 731 491069 56022 90080625
Mental status changes 207.22 22.71 8 491792 44671 90091976
Back pain 207.19 22.71 950 490850 316225 89820422
Breast cancer stage III 204.75 22.71 955 490845 83492 90053155
Injection site swelling 203.15 22.71 39 491761 59800 90076847
Drug tolerance decreased 202.28 22.71 501 491299 31629 90105018
Nail disorder 198.18 22.71 738 491062 58329 90078318
Cardiac disorder 197.51 22.71 35 491765 56837 90079810
Myocardial infarction 195.63 22.71 172 491628 105800 90030847
Aphasia 194.11 22.71 9 491791 42803 90093844
Colitis 193.01 22.71 69 491731 69873 90066774
Loss of personal independence in daily activities 191.84 22.71 1331 490469 134774 90001873
Unresponsive to stimuli 191.21 22.71 3 491797 38118 90098529
Hypothyroidism 190.48 22.71 30 491770 53097 90083550
Drug ineffective for unapproved indication 188.64 22.71 63 491737 66581 90070066
Heart rate decreased 187.85 22.71 32 491768 53473 90083174
Onychomadesis 187.50 22.71 613 491187 45385 90091262
Therapeutic product effect incomplete 187.41 22.71 1739 490061 192157 89944490
Obesity 185.90 22.71 1092 490708 104415 90032232
Deep vein thrombosis 185.02 22.71 136 491664 91484 90045163
Lethargy 183.48 22.71 57 491743 63082 90073565
Acute respiratory failure 182.43 22.71 13 491787 42905 90093742
Needle issue 182.26 22.71 295 491505 13639 90123008
Onychomycosis 181.06 22.71 529 491271 36847 90099800
Cholelithiasis 180.85 22.71 33 491767 52473 90084174
Illness 179.84 22.71 111 491689 81858 90054789
Orthostatic hypotension 179.74 22.71 12 491788 41815 90094832
Pneumonia aspiration 178.15 22.71 11 491789 40929 90095718
Abdominal pain 178.04 22.71 1336 490464 394385 89742262
Autoimmune disorder 177.39 22.71 856 490944 75888 90060759
Osteoarthritis 176.55 22.71 1730 490070 194000 89942647
Vertigo 176.08 22.71 79 491721 69732 90066915
Productive cough 175.21 22.71 100 491700 76963 90059684
Pulmonary hypertension 174.80 22.71 15 491785 42508 90094139
Urticaria 174.06 22.71 2520 489280 310214 89826433
Urinary incontinence 173.29 22.71 7 491793 37559 90099088
Premature delivery 173.02 22.71 9 491791 38753 90097894
Hypophagia 171.73 22.71 5 491795 35932 90100715
Restlessness 170.59 22.71 5 491795 35715 90100932
Generalised tonic-clonic seizure 170.01 22.71 4 491796 34899 90101748
Bursitis 168.50 22.71 1258 490542 130396 90006251
Respiratory distress 167.87 22.71 11 491789 38935 90097712
Influenza like illness 167.57 22.71 116 491684 80495 90056152
Blood potassium decreased 166.55 22.71 29 491771 47698 90088949
Blood pressure fluctuation 166.02 22.71 40 491760 52373 90084274
Gamma-glutamyltransferase increased 165.74 22.71 10 491790 37942 90098705
Thrombosis 165.19 22.71 96 491704 73155 90063492
Condition aggravated 165.01 22.71 4314 487486 591231 89545416
Lymphocyte count decreased 163.50 22.71 6 491794 35044 90101603
Haematocrit decreased 163.43 22.71 18 491782 41814 90094833
Cholestasis 163.39 22.71 8 491792 36291 90100356
Agranulocytosis 163.25 22.71 6 491794 34996 90101651
Nasal congestion 163.08 22.71 128 491672 83286 90053361
Ear pain 162.93 22.71 683 491117 57019 90079628
Throat irritation 162.65 22.71 33 491767 48662 90087985
Hypervolaemia 162.54 22.71 3 491797 32754 90103893
Pallor 162.37 22.71 5 491795 34160 90102487
Melaena 162.17 22.71 6 491794 34791 90101856
X-ray abnormal 162.05 22.71 579 491221 44845 90091802
Respiratory arrest 161.55 22.71 4 491796 33307 90103340
Prescribed underdose 160.78 22.71 819 490981 74200 90062447
Hepatic failure 160.65 22.71 15 491785 39713 90096934
Lip swelling 160.42 22.71 13 491787 38597 90098050
Osteonecrosis of jaw 160.18 22.71 14 491786 39089 90097558
Swelling face 160.11 22.71 124 491676 81228 90055419
Bone marrow failure 159.68 22.71 3 491797 32218 90104429
Urinary retention 156.01 22.71 13 491787 37731 90098916
Transient ischaemic attack 155.66 22.71 24 491776 43152 90093495
Hepatic function abnormal 155.38 22.71 31 491769 46257 90090390
Vomiting 154.17 22.71 3186 488614 785107 89351540
Drug delivery system malfunction 153.78 22.71 95 491705 1286 90135361
Jaundice 153.67 22.71 5 491795 32512 90104135
Haemorrhage 153.49 22.71 93 491707 69276 90067371
COVID-19 152.26 22.71 442 491358 168401 89968246
Road traffic accident 151.93 22.71 1053 490747 106573 90030074
Blood creatine phosphokinase increased 151.55 22.71 8 491792 34015 90102632
Haematuria 150.20 22.71 10 491790 34927 90101720
Dyskinesia 149.87 22.71 13 491787 36521 90100126
Eczema 149.60 22.71 50 491750 52820 90083827
Device malfunction 149.22 22.71 343 491457 20634 90116013
Blood calcium decreased 148.81 22.71 3 491797 30179 90106468
Abortion spontaneous 148.01 22.71 54 491746 54002 90082645
Hypomagnesaemia 147.81 22.71 12 491788 35576 90101071
Musculoskeletal pain 147.33 22.71 1499 490301 169752 89966895
C-reactive protein increased 146.74 22.71 1568 490232 179821 89956826
Blood urea increased 146.19 22.71 4 491796 30409 90106238
Burning sensation 146.18 22.71 81 491719 63371 90073276
Leukocytosis 145.62 22.71 5 491795 30985 90105662
Rheumatoid nodule 144.84 22.71 331 491469 19835 90116812
Macular degeneration 144.20 22.71 18 491782 37952 90098695
Nervousness 142.80 22.71 11 491789 34045 90102602
Live birth 142.09 22.71 823 490977 78284 90058363
Depressed mood 141.23 22.71 48 491752 50174 90086473
Exostosis 140.83 22.71 617 491183 52517 90084130
Muscle spasticity 140.63 22.71 467 491333 34855 90101792
Plasma cell myeloma 139.89 22.71 26 491774 40802 90095845
Arrhythmia 138.69 22.71 30 491770 42302 90094345
Haematoma 137.86 22.71 23 491777 39025 90097622
Coronary artery disease 137.83 22.71 12 491788 33611 90103036
Device defective 137.58 22.71 129 491671 3357 90133290
Shock 137.53 22.71 4 491796 28774 90107873
Septic shock 136.47 22.71 153 491647 84007 90052640
Incorrect dose administered 136.38 22.71 136 491664 78794 90057853
Injection site pruritus 135.64 22.71 61 491739 53773 90082874
Altered state of consciousness 135.63 22.71 9 491791 31523 90105124
Lupus vulgaris 135.63 22.71 544 491256 44515 90092132
Device dislocation 135.37 22.71 9 491791 31473 90105174
Asthenia 135.15 22.71 2060 489740 531691 89604956
Flatulence 134.14 22.71 30 491770 41337 90095310
Pericardial effusion 133.87 22.71 20 491780 36813 90099834
Respiratory disorder 133.61 22.71 700 491100 64116 90072531
Paraesthesia oral 133.39 22.71 10 491790 31649 90104998
Fatigue 132.57 22.71 7585 484215 1146438 88990209
Hepatic cytolysis 132.47 22.71 9 491791 30907 90105740
Pain in jaw 131.27 22.71 48 491752 47937 90088710
Dysuria 130.98 22.71 27 491773 39374 90097273
Sinus tachycardia 129.25 22.71 6 491794 28507 90108140
Abdominal pain lower 128.67 22.71 9 491791 30168 90106479
Irritability 128.16 22.71 20 491780 35642 90101005
Injury associated with device 128.09 22.71 139 491661 4325 90132322
Angina pectoris 127.79 22.71 28 491772 39132 90097515
Oedema peripheral 127.01 22.71 848 490952 257067 89879580
Eating disorder 126.96 22.71 6 491794 28067 90108580
Lymphadenopathy 126.57 22.71 45 491755 45730 90090917
Foetal exposure during pregnancy 126.30 22.71 38 491762 42937 90093710
Joint stiffness 126.19 22.71 790 491010 77252 90059395
Eye pruritus 125.70 22.71 8 491792 29019 90107628
Skin discolouration 125.23 22.71 42 491758 44273 90092374
Tinnitus 125.07 22.71 39 491761 43063 90093584
Dry eye 124.94 22.71 80 491720 57851 90078796
Eye swelling 124.62 22.71 9 491791 29377 90107270
Dysphonia 124.33 22.71 96 491704 62988 90073659
Ejection fraction decreased 124.19 22.71 4 491796 26249 90110398
Anti-cyclic citrullinated peptide antibody 124.00 22.71 377 491423 26844 90109803
Renal disorder 123.68 22.71 27 491773 37832 90098815
Haemoptysis 123.65 22.71 17 491783 33303 90103344
Rash macular 123.60 22.71 11 491789 30269 90106378
Product label confusion 122.99 22.71 336 491464 22514 90114133
Head injury 122.91 22.71 13 491787 31175 90105472
Transaminases increased 122.57 22.71 26 491774 37166 90099481
Blood pressure systolic increased 122.54 22.71 83 491717 58262 90078385
Sinus disorder 122.26 22.71 20 491780 34427 90102220
Stevens-Johnson syndrome 121.74 22.71 10 491790 29366 90107281
Panic attack 121.32 22.71 5 491795 26360 90110287
Hemiparesis 121.04 22.71 15 491785 31804 90104843
Haematemesis 121.01 22.71 19 491781 33707 90102940
Emotional distress 120.07 22.71 26 491774 36636 90100011
Unevaluable event 119.31 22.71 75 491725 54773 90081874
Diplopia 118.38 22.71 10 491790 28704 90107943
Red blood cell count decreased 117.60 22.71 52 491748 46299 90090348
Pollakiuria 117.50 22.71 19 491781 32986 90103661
Prescribed overdose 117.15 22.71 919 490881 96706 90039941
Muscle twitching 117.01 22.71 3 491797 24199 90112448
Joint dislocation 116.10 22.71 515 491285 44067 90092580
Blood lactate dehydrogenase increased 115.81 22.71 6 491794 25926 90110721
Acute myocardial infarction 115.79 22.71 24 491776 34866 90101781
Back injury 115.75 22.71 531 491269 46091 90090556
Retinitis 115.50 22.71 464 491336 37994 90098653
Ankylosing spondylitis 115.49 22.71 234 491566 12899 90123748
Liver disorder 114.78 22.71 1083 490717 120186 90016461
Eosinophilia 114.77 22.71 11 491789 28522 90108125
Diabetic ketoacidosis 114.46 22.71 4 491796 24403 90112244
Hepatocellular injury 114.30 22.71 12 491788 28946 90107701
No adverse event 114.20 22.71 120 491680 67862 90068785
Presyncope 113.93 22.71 18 491782 31787 90104860
Pancreatitis acute 113.19 22.71 19 491781 32096 90104551
Ventricular tachycardia 112.65 22.71 5 491795 24703 90111944
Rhinorrhoea 112.63 22.71 191 491609 88125 90048522
Cerebral haemorrhage 112.01 22.71 25 491775 34497 90102150
Rash maculo-papular 111.88 22.71 41 491759 40892 90095755
Cystitis 111.82 22.71 118 491682 66600 90070047
Metastases to liver 111.01 22.71 13 491787 28794 90107853
Circulatory collapse 110.47 22.71 6 491794 24898 90111749
Acute respiratory distress syndrome 110.41 22.71 13 491787 28673 90107974
Eye pain 109.80 22.71 51 491749 44117 90092530
Blood glucose decreased 109.32 22.71 4 491796 23425 90113222
Intestinal obstruction 108.82 22.71 33 491767 37098 90099549
Hypoacusis 108.75 22.71 12 491788 27838 90108809
Seronegative arthritis 108.16 22.71 278 491522 17956 90118691
Impaired quality of life 107.82 22.71 4 491796 23140 90113507
Blood sodium decreased 107.57 22.71 12 491788 27601 90109046
Drug tolerance 106.12 22.71 273 491527 17643 90119004
Blood parathyroid hormone decreased 105.46 22.71 216 491584 12000 90124647
Injection site bruising 105.14 22.71 78 491722 52229 90084418
Alanine aminotransferase increased 105.06 22.71 312 491488 118026 90018621
Sleep apnoea syndrome 105.02 22.71 22 491778 31725 90104922
Chronic sinusitis 104.76 22.71 6 491794 23796 90112851
Granuloma skin 104.47 22.71 199 491601 10481 90126166
Nightmare 103.89 22.71 3 491797 21722 90114925
Upper gastrointestinal haemorrhage 103.61 22.71 5 491795 22971 90113676
Dermatitis atopic 103.06 22.71 6 491794 23466 90113181
Clostridium difficile colitis 103.04 22.71 12 491788 26694 90109953
Premature baby 102.65 22.71 9 491791 25068 90111579
Liver function test increased 102.48 22.71 800 491000 84055 90052592
Lacrimation increased 102.35 22.71 13 491787 27049 90109598
Walking aid user 100.01 22.71 420 491380 35086 90101561
Myelodysplastic syndrome 99.55 22.71 3 491797 20900 90115747
Face oedema 99.29 22.71 7 491793 23311 90113336
Mental disorder 97.88 22.71 27 491773 32291 90104356
Feeling cold 97.35 22.71 16 491784 27449 90109198
Food allergy 96.94 22.71 12 491788 25466 90111181
Accidental overdose 96.87 22.71 18 491782 28255 90108392
Tubulointerstitial nephritis 96.27 22.71 12 491788 25331 90111316
Fungal infection 96.06 22.71 56 491744 42605 90094042
Wheezing 95.23 22.71 1818 489982 236262 89900385
Foetal death 95.12 22.71 4 491796 20719 90115928
Vaginal haemorrhage 94.94 22.71 26 491774 31245 90105402
Device issue 94.88 22.71 364 491436 29173 90107474
Panniculitis 94.78 22.71 229 491571 14229 90122418
Hyperlipidaemia 94.42 22.71 8 491792 22908 90113739
Visual acuity reduced 94.23 22.71 9 491791 23401 90113246
Sneezing 94.20 22.71 23 491777 29846 90106801
Lung disorder 93.93 22.71 1234 490566 148649 89987998
Procedural pain 93.60 22.71 32 491768 33328 90103319
Liver function test abnormal 93.25 22.71 83 491717 50762 90085885
C-reactive protein 93.04 22.71 377 491423 30990 90105657
Cardiomyopathy 92.42 22.71 4 491796 20202 90116445
Adverse drug reaction 91.63 22.71 1003 490797 115698 90020949
Heart rate irregular 90.96 22.71 12 491788 24256 90112391
Ischaemic stroke 90.61 22.71 8 491792 22158 90114489
Injection site mass 90.23 22.71 8 491792 22082 90114565
Disseminated intravascular coagulation 90.18 22.71 7 491793 21531 90115116
Infusion site pain 89.97 22.71 4 491796 19734 90116913
Gastritis 89.57 22.71 58 491742 41695 90094952
Body temperature increased 89.49 22.71 479 491321 44231 90092416
Laryngitis 89.17 22.71 525 491275 50228 90086419
Lupus-like syndrome 88.89 22.71 510 491290 48336 90088311
Fluid retention 88.15 22.71 219 491581 87872 90048775
Drug hypersensitivity 87.77 22.71 3207 488593 460402 89676245
Rash papular 86.99 22.71 6 491794 20349 90116298
Restless legs syndrome 86.94 22.71 10 491790 22460 90114187
Swollen tongue 86.73 22.71 73 491727 45883 90090764
Therapeutic response unexpected 86.53 22.71 9 491791 21871 90114776
Skin fissures 86.47 22.71 7 491793 20802 90115845
Blepharospasm 85.75 22.71 555 491245 54890 90081757
Cyanosis 85.33 22.71 5 491795 19450 90117197
Speech disorder 85.31 22.71 73 491727 45512 90091135
Product dose omission in error 84.91 22.71 7 491793 20496 90116151
Femur fracture 84.78 22.71 75 491725 46007 90090640
Sensory loss 84.63 22.71 3 491797 18072 90118575
Diabetes mellitus inadequate control 84.47 22.71 4 491796 18680 90117967
Motor dysfunction 84.17 22.71 5 491795 19225 90117422
Skin haemorrhage 84.02 22.71 9 491791 21371 90115276
Coeliac disease 83.96 22.71 470 491330 44140 90092507
Chromaturia 83.95 22.71 5 491795 19182 90117465
Oral candidiasis 83.50 22.71 44 491756 35411 90101236
Therapy non-responder 83.37 22.71 1120 490680 135584 90001063
Cardiomegaly 82.60 22.71 5 491795 18920 90117727
Vaginal discharge 82.42 22.71 6 491794 19458 90117189
Mitral valve incompetence 82.39 22.71 12 491788 22512 90114135
Eye irritation 81.76 22.71 41 491759 33937 90102710
Transfusion 81.55 22.71 3 491797 17485 90119162
Faeces discoloured 81.22 22.71 10 491790 21310 90115337
Osteonecrosis 81.22 22.71 21 491779 26220 90110427
Cytomegalovirus infection 80.99 22.71 22 491778 26580 90110067
Myoclonus 80.91 22.71 6 491794 19162 90117485
Small intestinal obstruction 80.80 22.71 10 491790 21224 90115423
Bronchospasm 80.67 22.71 9 491791 20700 90115947
Mood altered 79.74 22.71 3 491797 17141 90119506
Blood pressure systolic abnormal 79.71 22.71 7 491793 19471 90117176
Dry mouth 79.68 22.71 1423 490377 182636 89954011
Full blood count abnormal 79.66 22.71 50 491750 36547 90100100
Injection site rash 79.45 22.71 17 491783 24156 90112491
Aspartate aminotransferase increased 79.22 22.71 289 491511 102648 90033999
Hepatic cirrhosis 78.96 22.71 601 491199 62652 90073995
Toothache 78.68 22.71 13 491787 22217 90114430
Loss of consciousness 78.42 22.71 443 491357 139795 89996852
Hepatic steatosis 78.33 22.71 52 491748 36893 90099754
Retching 78.09 22.71 7 491793 19152 90117495
Hip fracture 77.97 22.71 41 491759 33036 90103611
Poor quality sleep 77.90 22.71 19 491781 24674 90111973
Nervous system disorder 77.84 22.71 12 491788 21581 90115066
Haemorrhoids 77.76 22.71 24 491776 26678 90109969
Sinus congestion 77.47 22.71 26 491774 27398 90109249
Therapy interrupted 77.04 22.71 95 491705 50013 90086634
Bacteraemia 76.83 22.71 14 491786 22286 90114361
Bronchitis 76.65 22.71 500 491300 152427 89984220
Hypersomnia 75.30 22.71 13 491787 21518 90115129
Thirst 75.28 22.71 3 491797 16292 90120355
Pneumonitis 75.28 22.71 77 491723 44093 90092554
Skin burning sensation 75.20 22.71 9 491791 19602 90117045
Blood albumin decreased 74.68 22.71 4 491796 16799 90119848
Limb injury 74.36 22.71 39 491761 31469 90105178
Sputum discoloured 74.27 22.71 11 491789 20380 90116267
Acne 73.88 22.71 31 491769 28476 90108171
Respiratory rate increased 73.74 22.71 3 491797 15998 90120649
Hypoalbuminaemia 73.20 22.71 3 491797 15894 90120753
Glomerular filtration rate decreased 72.34 22.71 5 491795 16927 90119720
Complication associated with device 71.99 22.71 10 491790 19439 90117208
Haematochezia 71.96 22.71 175 491625 70738 90065909
Blindness 71.96 22.71 27 491773 26541 90110106
Neutrophil count increased 71.70 22.71 10 491790 19380 90117267
Therapy partial responder 71.44 22.71 16 491784 22027 90114620
Blood pressure diastolic decreased 71.43 22.71 28 491772 26798 90109849
Spinal fracture 71.31 22.71 16 491784 22000 90114647
Mental impairment 71.25 22.71 5 491795 16715 90119932
Hypoaesthesia 71.20 22.71 2220 489580 311990 89824657
Red blood cell sedimentation rate abnormal 71.07 22.71 290 491510 23914 90112733
Skin lesion 70.95 22.71 59 491741 37306 90099341
Gastric ulcer 70.89 22.71 30 491770 27418 90109229
Cardiac murmur 70.64 22.71 8 491792 18186 90118461
Cerebral infarction 70.42 22.71 28 491772 26568 90110079
Seasonal allergy 69.98 22.71 19 491781 22964 90113683
Poisoning 69.64 22.71 3 491797 15214 90121433
Adverse reaction 69.06 22.71 332 491468 29380 90107267
Hemiplegia 68.38 22.71 5 491795 16155 90120492
Staphylococcal infection 68.19 22.71 98 491702 48341 90088306
Schizophrenia 68.05 22.71 3 491797 14911 90121736
Fear 67.95 22.71 6 491794 16616 90120031
Metastases to central nervous system 67.39 22.71 8 491792 17534 90119113
Throat tightness 67.38 22.71 38 491762 29446 90107201
Product prescribing error 67.26 22.71 40 491760 30105 90106542
Lung infiltration 66.81 22.71 4 491796 15278 90121369
Rales 66.68 22.71 5 491795 15822 90120825
Oral pain 66.64 22.71 48 491752 32635 90104012
Rhinitis allergic 66.13 22.71 7 491793 16778 90119869
Neuralgia 65.89 22.71 45 491755 31455 90105192
Ocular hyperaemia 65.88 22.71 52 491748 33746 90102901
Blood pressure diastolic abnormal 65.31 22.71 14 491786 19867 90116780
Disease recurrence 64.90 22.71 65 491735 37588 90099059
Acute myeloid leukaemia 64.88 22.71 16 491784 20624 90116023
Pruritus 64.83 22.71 3575 488225 537950 89598697
Candida infection 64.39 22.71 54 491746 34003 90102644
Blood pressure abnormal 64.19 22.71 14 491786 19631 90117016
Bedridden 63.75 22.71 177 491623 11971 90124676
Left ventricular dysfunction 63.65 22.71 4 491796 14665 90121982
Caesarean section 63.28 22.71 12 491788 18565 90118082
Injection site urticaria 62.72 22.71 11 491789 18000 90118647
Device difficult to use 62.58 22.71 10 491790 17515 90119132
Pustular psoriasis 62.35 22.71 232 491568 18324 90118323
Metastases to lung 62.16 22.71 7 491793 15984 90120663
Blood triglycerides increased 62.04 22.71 3 491797 13758 90122889
Anger 61.82 22.71 3 491797 13717 90122930
Dementia 61.75 22.71 26 491774 23835 90112812
Acute generalised exanthematous pustulosis 61.73 22.71 3 491797 13700 90122947
Enthesopathy 61.70 22.71 149 491651 9255 90127392
Red blood cell sedimentation rate 61.44 22.71 99 491701 4559 90132088
Aphthous ulcer 61.43 22.71 10 491790 17277 90119370
Purpura 61.32 22.71 5 491795 14773 90121874
Cataract 61.18 22.71 194 491606 71898 90064749
Myopathy 60.77 22.71 3 491797 13515 90123132
Therapeutic response shortened 60.72 22.71 24 491776 22855 90113792
Arthritis 60.30 22.71 1258 490542 166057 89970590
Peripheral coldness 59.65 22.71 4 491796 13888 90122759
Finger deformity 59.54 22.71 343 491457 32554 90104093
Troponin increased 59.54 22.71 3 491797 13278 90123369
Ankle arthroplasty 59.28 22.71 75 491725 2756 90133891
Facial pain 59.02 22.71 3 491797 13179 90123468
Vitamin D deficiency 58.41 22.71 12 491788 17544 90119103
Progressive multifocal leukoencephalopathy 58.06 22.71 8 491792 15647 90121000
Osteopenia 58.04 22.71 26 491774 22976 90113671
Hyperthyroidism 57.93 22.71 14 491786 18296 90118351
Skin necrosis 57.92 22.71 213 491587 16728 90119919
Pain of skin 57.83 22.71 9 491791 16073 90120574
Gangrene 57.43 22.71 3 491797 12873 90123774
Malnutrition 57.15 22.71 15 491785 18543 90118104
Haemophagocytic lymphohistiocytosis 57.09 22.71 8 491792 15451 90121196
Polyneuropathy 57.02 22.71 17 491783 19324 90117323
Bone disorder 57.00 22.71 27 491773 23093 90113554
Sensory disturbance 56.87 22.71 8 491792 15405 90121242
Joint destruction 56.79 22.71 180 491620 13107 90123540
Multiple sclerosis 56.62 22.71 41 491759 27799 90108848
Rib fracture 56.33 22.71 37 491763 26398 90110249
Injection site warmth 56.19 22.71 13 491787 17502 90119145
Petechiae 56.17 22.71 9 491791 15732 90120915
Lymphoedema 56.12 22.71 5 491795 13748 90122899
Hiatus hernia 56.10 22.71 34 491766 25327 90111320
Subarachnoid haemorrhage 56.04 22.71 14 491786 17890 90118757
Upper respiratory tract infection 55.80 22.71 437 491363 127881 90008766
Ageusia 55.58 22.71 10 491790 16066 90120581
Device breakage 54.97 22.71 6 491794 14038 90122609
Product administration error 54.94 22.71 38 491762 26385 90110262
Device leakage 54.85 22.71 148 491652 9843 90126804
Mycotic allergy 54.79 22.71 46 491754 1030 90135617
Tricuspid valve incompetence 54.51 22.71 12 491788 16719 90119928
Systemic lupus erythematosus rash 54.38 22.71 66 491734 2323 90134324
Poor venous access 54.32 22.71 19 491781 19508 90117139
Shock haemorrhagic 54.16 22.71 3 491797 12242 90124405
Toxic skin eruption 54.13 22.71 10 491790 15764 90120883
Stress cardiomyopathy 54.11 22.71 5 491795 13350 90123297
Product dose omission issue 53.96 22.71 2013 489787 289674 89846973
Hypoaesthesia oral 53.30 22.71 10 491790 15590 90121057
Blood calcium increased 53.19 22.71 3 491797 12055 90124592
Insomnia 53.01 22.71 2264 489536 331210 89805437
Supraventricular tachycardia 52.66 22.71 12 491788 16324 90120323
Breast cancer stage II 52.39 22.71 350 491450 34984 90101663
Cholecystitis 52.05 22.71 14 491786 17026 90119621
Pseudomonas infection 51.93 22.71 9 491791 14856 90121791
Disability 51.90 22.71 389 491411 40356 90096291
Taste disorder 51.58 22.71 536 491264 61010 90075637
Delusion 51.50 22.71 7 491793 13833 90122814
Anaphylactic reaction 51.38 22.71 272 491528 87252 90049395
Aplastic anaemia 51.10 22.71 6 491794 13263 90123384
Maternal exposure timing unspecified 50.66 22.71 249 491551 22234 90114413
Tenosynovitis 50.52 22.71 184 491616 14383 90122264
Hypertensive crisis 49.99 22.71 17 491783 17767 90118880
Oedema 49.88 22.71 1432 490368 198863 89937784
Ileus 49.78 22.71 14 491786 16532 90120115
Atelectasis 49.57 22.71 36 491764 24373 90112274
Muscle tightness 49.53 22.71 7 491793 13432 90123215
Renal cyst 49.51 22.71 6 491794 12944 90123703
Dialysis 49.42 22.71 3 491797 11326 90125321
Oesophagitis 49.35 22.71 16 491784 17233 90119414
Blood pressure diastolic increased 49.30 22.71 6 491794 12900 90123747
Colitis ischaemic 49.02 22.71 5 491795 12341 90124306
Upper-airway cough syndrome 49.02 22.71 11 491789 15124 90121523
Hepatomegaly 48.97 22.71 7 491793 13319 90123328
Facial paralysis 48.91 22.71 12 491788 15522 90121125
Head discomfort 48.80 22.71 14 491786 16319 90120328
Device related infection 48.61 22.71 41 491759 25745 90110902
Peritonitis 48.59 22.71 23 491777 19682 90116965
Transplant rejection 48.56 22.71 6 491794 12752 90123895
Amenorrhoea 48.55 22.71 4 491796 11718 90124929
Lipase increased 48.30 22.71 3 491797 11108 90125539
Cold sweat 48.17 22.71 9 491791 14072 90122575
Breast cancer female 47.85 22.71 11 491789 14875 90121772
Pneumothorax 47.84 22.71 22 491778 19145 90117502
Urine output decreased 47.79 22.71 6 491794 12597 90124050
Proctitis 47.63 22.71 12 491788 15247 90121400
Hepatitis acute 47.14 22.71 3 491797 10884 90125763
Glycosylated haemoglobin increased 47.13 22.71 13 491787 15549 90121098
Peptic ulcer haemorrhage 47.08 22.71 43 491757 1081 90135566
Breast cancer metastatic 47.04 22.71 12 491788 15120 90121527
Oral herpes 47.02 22.71 68 491732 33456 90103191
Cardiac failure acute 46.93 22.71 5 491795 11924 90124723
Escherichia infection 46.81 22.71 14 491786 15881 90120766
Ventricular extrasystoles 46.34 22.71 8 491792 13242 90123405
Increased appetite 46.11 22.71 5 491795 11760 90124887
Skin laceration 45.96 22.71 44 491756 25991 90110656
Dermatitis contact 45.84 22.71 9 491791 13586 90123061
Abdominal distension 45.73 22.71 470 491330 130131 90006516
Pelvic fracture 45.56 22.71 13 491787 15206 90121441
Central nervous system lesion 45.52 22.71 5 491795 11641 90125006
Iron deficiency anaemia 45.37 22.71 37 491763 23625 90113022
Influenza 45.22 22.71 510 491290 138754 89997893
Apathy 45.09 22.71 4 491796 11036 90125611
Choking 44.98 22.71 6 491794 12027 90124620
Hypertension 44.83 22.71 2968 488832 454564 89682083
Anal incontinence 44.79 22.71 16 491784 16214 90120433
Heavy menstrual bleeding 44.75 22.71 28 491772 20502 90116145
Breast pain 44.73 22.71 3 491797 10415 90126232
Underdose 44.59 22.71 469 491331 53548 90083099
Hydronephrosis 44.46 22.71 7 491793 12395 90124252
Intervertebral disc degeneration 44.42 22.71 19 491781 17255 90119392
Diabetes mellitus 44.28 22.71 191 491609 64684 90071963
Bronchopulmonary aspergillosis 44.28 22.71 5 491795 11393 90125254
Abortion induced 44.26 22.71 6 491794 11882 90124765
Chest pain 44.10 22.71 1359 490441 318286 89818361
Malaise 44.05 22.71 2667 489133 583319 89553328
Acute coronary syndrome 43.94 22.71 4 491796 10809 90125838
Arthrodesis 43.87 22.71 67 491733 2945 90133702
Clostridium difficile infection 43.84 22.71 81 491719 36164 90100483
Bladder disorder 43.73 22.71 4 491796 10768 90125879
Intentional dose omission 43.48 22.71 21 491779 17762 90118885
Exposure via skin contact 43.39 22.71 4 491796 10701 90125946
Emphysema 43.26 22.71 7 491793 12148 90124499
Intestinal perforation 43.17 22.71 11 491789 13870 90122777
Uveitis 43.14 22.71 186 491614 15717 90120930
Ulcer haemorrhage 42.88 22.71 267 491533 26054 90110593
Myocarditis 42.82 22.71 11 491789 13795 90122852
Premature labour 42.77 22.71 10 491790 13366 90123281
Major depression 42.76 22.71 3 491797 10032 90126615
Subcutaneous drug absorption impaired 42.75 22.71 166 491634 13379 90123268
Rectal haemorrhage 42.74 22.71 268 491532 82476 90054171
Hypocalcaemia 42.64 22.71 105 491695 42263 90094384
Enterococcal infection 42.54 22.71 3 491797 9988 90126659
Concomitant disease aggravated 42.45 22.71 6 491794 11512 90125135
Nail operation 42.32 22.71 52 491748 1854 90134793
Blood iron abnormal 41.93 22.71 77 491723 3943 90132704
Spinal osteoarthritis 41.89 22.71 26 491774 19122 90117525
Sudden death 41.84 22.71 5 491795 10904 90125743
Therapeutic response decreased 41.78 22.71 702 491098 89027 90047620
Autoimmune hepatitis 41.61 22.71 4 491796 10347 90126300
Oral disorder 41.57 22.71 4 491796 10341 90126306
Enteritis 41.45 22.71 4 491796 10317 90126330
Klebsiella infection 41.33 22.71 4 491796 10293 90126354
Nocturia 41.12 22.71 4 491796 10251 90126396
Gingival pain 40.80 22.71 3 491797 9649 90126998
Deformity 40.76 22.71 152 491648 12018 90124629
Middle insomnia 40.63 22.71 20 491780 16731 90119916
Gallbladder disorder 40.48 22.71 29 491771 19774 90116873
Wrist fracture 40.47 22.71 17 491783 15607 90121040
Headache 39.85 22.71 4087 487713 858659 89277988
Polyarthritis 39.76 22.71 201 491599 18149 90118498
Osteoporosis 39.54 22.71 740 491060 95791 90040856
Cholecystitis acute 39.53 22.71 3 491797 9401 90127246
Decubitus ulcer 39.46 22.71 8 491792 11805 90124842
Anosmia 39.07 22.71 4 491796 9844 90126803
Malignant mediastinal neoplasm 38.93 22.71 43 491757 1365 90135282
Metastases to lymph nodes 38.87 22.71 8 491792 11681 90124966
Stress 38.83 22.71 270 491530 81125 90055522
Skin abrasion 38.82 22.71 7 491793 11228 90125419
Atrial flutter 38.73 22.71 6 491794 10752 90125895
Mass 38.69 22.71 18 491782 15559 90121088
Spondylitis 38.60 22.71 166 491634 14012 90122635
Temperature intolerance 38.45 22.71 9 491791 12021 90124626
Scab 38.44 22.71 4 491796 9717 90126930
Hypogammaglobulinaemia 38.32 22.71 6 491794 10668 90125979
Gout 38.14 22.71 22 491778 16837 90119810
Concussion 38.13 22.71 7 491793 11084 90125563
Feeding disorder 38.01 22.71 24 491776 17488 90119159
Pre-eclampsia 37.92 22.71 7 491793 11041 90125606
Acute pulmonary oedema 37.73 22.71 4 491796 9576 90127071
Hypokinesia 37.68 22.71 19 491781 15678 90120969
Musculoskeletal chest pain 37.60 22.71 44 491756 23706 90112941
Polyuria 37.54 22.71 5 491795 10035 90126612
Dental caries 37.49 22.71 8 491792 11389 90125258
Enterocolitis 37.43 22.71 6 491794 10484 90126163
Red cell distribution width increased 37.34 22.71 10 491790 12197 90124450
Embolism 37.23 22.71 4 491796 9477 90127170
Basal cell carcinoma 37.15 22.71 309 491491 33080 90103567
Platelet count increased 37.12 22.71 35 491765 20824 90115823
Anaphylactic shock 37.06 22.71 72 491728 31545 90105102
Intestinal ischaemia 36.88 22.71 3 491797 8880 90127767
Bunion operation 36.74 22.71 41 491759 1317 90135330
Anticipatory anxiety 36.44 22.71 39 491761 1194 90135453
Tooth disorder 36.27 22.71 71 491729 31019 90105628
Porphyria acute 36.26 22.71 193 491607 17782 90118865
Renal injury 36.23 22.71 6 491794 10237 90126410
Eyelid oedema 36.14 22.71 9 491791 11525 90125122
Respiratory tract infection 36.14 22.71 181 491619 58897 90077750
Drug resistance 35.99 22.71 69 491731 30380 90106267
Intermenstrual bleeding 35.94 22.71 4 491796 9219 90127428
Nerve injury 35.78 22.71 137 491663 10969 90125678
Erythema multiforme 35.67 22.71 11 491789 12235 90124412
Nerve compression 35.62 22.71 7 491793 10559 90126088
Secretion discharge 35.60 22.71 21 491779 15875 90120772
Diverticulum intestinal 35.54 22.71 4 491796 9138 90127509
Bacterial infection 35.46 22.71 45 491755 23399 90113248
Coronary artery occlusion 35.20 22.71 3 491797 8551 90128096
White blood cell count increased 35.14 22.71 217 491583 67024 90069623
Foot operation 34.93 22.71 118 491682 8883 90127764
Skin irritation 34.92 22.71 15 491785 13588 90123059
Eyelid ptosis 34.86 22.71 4 491796 9002 90127645
Low birth weight baby 34.73 22.71 5 491795 9462 90127185
Feeling hot 34.69 22.71 264 491536 77744 90058903
Depression 34.48 22.71 1308 490492 299293 89837354
Product complaint 34.47 22.71 15 491785 13485 90123162
Drug dependence 34.19 22.71 67 491733 29260 90107387
Therapy change 34.03 22.71 3 491797 8319 90128328
Initial insomnia 33.96 22.71 5 491795 9305 90127342
Injection site haemorrhage 33.62 22.71 64 491736 28254 90108393
Aspiration 33.39 22.71 22 491778 15671 90120976
Genital haemorrhage 33.35 22.71 4 491796 8698 90127949
Extremity contracture 33.21 22.71 38 491762 1255 90135392
Gastroenteritis 33.03 22.71 68 491732 29161 90107486
Encephalitis 32.44 22.71 10 491790 11124 90125523
Papule 32.41 22.71 3 491797 7999 90128648
Haemolysis 32.40 22.71 4 491796 8506 90128141
Administration site pain 32.34 22.71 36 491764 1153 90135494
Sensitivity to weather change 32.03 22.71 5 491795 8909 90127738
Emotional disorder 31.94 22.71 21 491779 14976 90121671
Diverticulum 31.67 22.71 13 491787 12100 90124547
Blood pressure systolic decreased 31.55 22.71 6 491794 9264 90127383
Post procedural complication 31.54 22.71 34 491766 19008 90117639
Blood folate decreased 31.47 22.71 42 491758 1628 90135019
General symptom 31.32 22.71 160 491640 14508 90122139
Abdominal pain upper 31.12 22.71 2150 489650 330524 89806123
Oropharyngeal discomfort 31.06 22.71 3 491797 7732 90128915
Proctalgia 30.85 22.71 4 491796 8194 90128453
Blood urine present 30.73 22.71 29 491771 17249 90119398
Pancreatitis 30.72 22.71 237 491563 69589 90067058
Increased tendency to bruise 30.70 22.71 13 491787 11877 90124770
Photosensitivity reaction 30.39 22.71 31 491769 17776 90118871
Mouth ulceration 30.24 22.71 113 491687 39861 90096786
Menstruation irregular 30.17 22.71 4 491796 8056 90128591
Interstitial lung disease 30.13 22.71 267 491533 76138 90060509
Paronychia 29.91 22.71 4 491796 8002 90128645
Vitamin B12 deficiency 29.81 22.71 3 491797 7483 90129164
Blood loss anaemia 29.73 22.71 9 491791 10131 90126516
Hypermobility syndrome 29.51 22.71 30 491770 864 90135783
Drug-induced liver injury 29.30 22.71 669 491131 89649 90046998
Serum ferritin increased 29.28 22.71 3 491797 7378 90129269
Compression fracture 29.26 22.71 6 491794 8783 90127864
Personality change 28.98 22.71 3 491797 7318 90129329
Urosepsis 28.87 22.71 44 491756 21188 90115459
Hyperthermia 28.84 22.71 10 491790 10325 90126322
Sarcoidosis 28.65 22.71 11 491789 10662 90125985
Blood glucose abnormal 28.61 22.71 8 491792 9484 90127163
Impaired gastric emptying 28.57 22.71 17 491783 12792 90123855
Fistula 28.47 22.71 15 491785 12074 90124573
Eye injury 28.46 22.71 127 491673 10893 90125754
Drug dose omission by device 28.38 22.71 10 491790 10221 90126426
Pregnancy 28.36 22.71 484 491316 61563 90075084
Injection site extravasation 28.33 22.71 7 491793 9012 90127635
Gestational diabetes 28.25 22.71 11 491789 10571 90126076
Bipolar disorder 28.17 22.71 7 491793 8978 90127669
Herpes simplex 28.16 22.71 10 491790 10171 90126476
Cyst 28.07 22.71 29 491771 16532 90120115
Injection site discolouration 27.83 22.71 8 491792 9312 90127335
Amylase increased 27.73 22.71 3 491797 7069 90129578
Tooth extraction 27.54 22.71 14 491786 11499 90125148
Hospitalisation 27.54 22.71 509 491291 127591 90009056
Ovarian cyst 27.51 22.71 32 491768 17286 90119361
Product prescribing issue 27.51 22.71 5 491795 7974 90128673
Accidental exposure to product 27.44 22.71 351 491449 42015 90094632
Dry throat 27.42 22.71 5 491795 7955 90128692
Thrombocytosis 27.38 22.71 3 491797 6998 90129649
Escherichia urinary tract infection 27.25 22.71 21 491779 13794 90122853
Blood thyroid stimulating hormone increased 27.07 22.71 8 491792 9147 90127500
Expired product administered 26.98 22.71 3 491797 6919 90129728
Skin disorder 26.97 22.71 105 491695 36601 90100046
Eye disorder 26.69 22.71 69 491731 27321 90109326
Cytomegalovirus infection reactivation 26.65 22.71 5 491795 7795 90128852
Dizziness postural 26.61 22.71 8 491792 9045 90127602
Odynophagia 26.56 22.71 8 491792 9035 90127612
Myasthenia gravis 26.50 22.71 3 491797 6822 90129825
Abnormal loss of weight 26.49 22.71 3 491797 6820 90129827
Delirium 26.48 22.71 748 491052 103611 90033036
Administration site infection 26.43 22.71 9 491791 24 90136623
Upper limb fracture 26.29 22.71 48 491752 21530 90115117
Pyrexia 26.21 22.71 3161 488639 657324 89479323
Respiratory syncytial virus infection 26.20 22.71 12 491788 10468 90126179
Gastritis erosive 26.15 22.71 3 491797 6752 90129895
Carpal tunnel syndrome 25.92 22.71 57 491743 23871 90112776
Dengue fever 25.73 22.71 28 491772 874 90135773
Angina unstable 25.68 22.71 4 491796 7139 90129508
Cellulitis 25.67 22.71 345 491455 90992 90045655
Swollen joint count 25.66 22.71 104 491696 8549 90128098
Epstein-Barr virus infection 25.62 22.71 12 491788 10332 90126315
Disease susceptibility 25.57 22.71 17 491783 263 90136384
Infusion site extravasation 25.55 22.71 12 491788 10316 90126331
Endocarditis 25.53 22.71 4 491796 7109 90129538
Tooth loss 25.47 22.71 5 491795 7549 90129098
Conjunctivitis 25.47 22.71 68 491732 26638 90110009
Hypovolaemic shock 25.44 22.71 4 491796 7090 90129557
Intraocular pressure increased 25.44 22.71 4 491796 7089 90129558
Insurance issue 25.22 22.71 14 491786 10944 90125703
Extra dose administered 25.14 22.71 9 491791 9109 90127538
Staphylococcal bacteraemia 25.07 22.71 5 491795 7464 90129183
Tooth fracture 25.05 22.71 19 491781 12581 90124066
Flank pain 25.03 22.71 41 491759 19181 90117466
Gastrooesophageal reflux disease 24.97 22.71 699 491101 165638 89971009
Blood creatinine decreased 24.96 22.71 3 491797 6512 90130135
Residual urine volume increased 24.92 22.71 12 491788 95 90136552
Ear infection 24.91 22.71 524 491276 69251 90067396
Eye discharge 24.82 22.71 7 491793 8251 90128396
Aspergillus infection 24.66 22.71 14 491786 10809 90125838
Injection site induration 24.64 22.71 13 491787 10455 90126192
Oral mucosal blistering 24.62 22.71 4 491796 6920 90129727
Atypical femur fracture 24.49 22.71 3 491797 6418 90130229
Neurological symptom 24.24 22.71 4 491796 6843 90129804
Ocular discomfort 24.24 22.71 3 491797 6367 90130280
Deafness neurosensory 24.21 22.71 4 491796 6837 90129810
Spinal fusion surgery 24.17 22.71 131 491669 12152 90124495
Spinal compression fracture 24.16 22.71 28 491772 15150 90121497
Pelvic floor muscle weakness 24.11 22.71 11 491789 76 90136571
Intracranial pressure increased 24.07 22.71 4 491796 6807 90129840
Periorbital oedema 24.01 22.71 4 491796 6795 90129852
Proteinuria 24.00 22.71 57 491743 23234 90113413
Dyspepsia 23.98 22.71 1310 490490 196850 89939797
Wrong product administered 23.98 22.71 6 491794 7659 90128988
Essential hypertension 23.96 22.71 3 491797 6312 90130335
Device use error 23.89 22.71 5 491795 7216 90129431
Infusion site pruritus 23.85 22.71 4 491796 6761 90129886
Pneumonia viral 23.84 22.71 9 491791 8814 90127833
Thermal burn 23.83 22.71 4 491796 6758 90129889
Pelvic pain 23.73 22.71 29 491771 15328 90121319
Scratch 23.59 22.71 12 491788 9854 90126793
Psychiatric symptom 23.41 22.71 5 491795 7113 90129534
Hepatic enzyme 23.39 22.71 73 491727 5271 90131376
Eye movement disorder 23.38 22.71 3 491797 6195 90130452
Gastric haemorrhage 23.33 22.71 5 491795 7098 90129549
Faeces soft 23.27 22.71 6 491794 7505 90129142
Dermatitis 23.20 22.71 54 491746 22166 90114481
Ligament sprain 23.16 22.71 27 491773 14572 90122075
Immunosuppression 23.01 22.71 19 491781 12058 90124589
Hereditary angioedema 22.99 22.71 11 491789 9354 90127293
Eye inflammation 22.96 22.71 7 491793 7844 90128803
Large intestine perforation 22.95 22.71 12 491788 9700 90126947
Rash vesicular 22.76 22.71 173 491627 18024 90118623
Ecchymosis 22.73 22.71 20 491780 12303 90124344

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
Device deployment issue 975.09 19.07 198 34427 457 42586253
Product dose omission issue 850.31 19.07 819 33806 153546 42433164
Drug ineffective 727.09 19.07 1578 33047 628619 41958091
Synovitis 494.58 19.07 245 34380 15322 42571388
Rheumatoid arthritis 428.62 19.07 320 34305 42120 42544590
Treatment failure 404.57 19.07 364 34261 62260 42524450
Therapeutic product effect decreased 383.75 19.07 290 34335 38860 42547850
Psoriatic arthropathy 325.31 19.07 220 34405 24747 42561963
Needle issue 315.18 19.07 150 34475 8577 42578133
Ankylosing spondylitis 300.63 19.07 136 34489 6920 42579790
Accidental exposure to product 290.53 19.07 190 34435 20203 42566507
Lower respiratory tract infection 255.07 19.07 234 34391 40972 42545738
Enthesopathy 244.24 19.07 105 34520 4723 42581987
Device issue 225.12 19.07 139 34486 13370 42573340
C-reactive protein abnormal 222.82 19.07 121 34504 9140 42577570
Product use issue 221.95 19.07 292 34333 76459 42510251
Tenosynovitis 214.37 19.07 95 34530 4600 42582110
Drug specific antibody present 212.15 19.07 90 34535 3916 42582794
Acute kidney injury 210.05 19.07 26 34599 367311 42219399
Uveitis 203.59 19.07 114 34511 9144 42577566
Pain 197.90 19.07 538 34087 244310 42342400
Musculoskeletal stiffness 197.52 19.07 239 34386 57526 42529184
Joint swelling 192.32 19.07 256 34369 67766 42518944
Device malfunction 190.70 19.07 121 34504 12206 42574504
Drug hypersensitivity 184.51 19.07 307 34318 99082 42487628
Device defective 179.55 19.07 63 34562 1625 42585085
Alanine aminotransferase abnormal 178.55 19.07 85 34540 4859 42581851
Drug intolerance 169.16 19.07 263 34362 80161 42506549
Toxicity to various agents 167.27 19.07 4 34621 229132 42357578
Contraindicated product administered 163.13 19.07 147 34478 25125 42561585
Arthralgia 154.79 19.07 440 34185 204798 42381912
Tongue disorder 151.19 19.07 78 34547 5305 42581405
Drug interaction 147.43 19.07 21 34604 266978 42319732
Oral herpes 142.12 19.07 84 34541 7460 42579250
Device leakage 137.15 19.07 92 34533 10193 42576517
Inappropriate schedule of product administration 129.31 19.07 258 34367 95644 42491066
Drug delivery system malfunction 125.79 19.07 36 34589 465 42586245
Dyspnoea 122.60 19.07 108 34517 442513 42144197
Death 122.27 19.07 122 34503 471063 42115647
Pneumonia 111.89 19.07 653 33972 421496 42165214
Red blood cell sedimentation rate abnormal 111.82 19.07 57 34568 3779 42582931
Arthropathy 106.90 19.07 126 34499 29471 42557239
Infection 105.35 19.07 261 34364 111807 42474903
Nasopharyngitis 103.77 19.07 218 34407 83778 42502932
Injury associated with device 103.65 19.07 40 34585 1357 42585353
Arthritis 98.92 19.07 145 34480 41920 42544790
Tendonitis 98.37 19.07 74 34551 9820 42576890
Therapeutic response decreased 97.97 19.07 135 34490 36877 42549833
Underdose 97.92 19.07 92 34533 16574 42570136
Anaemia 97.88 19.07 53 34572 280225 42306485
Confusional state 97.71 19.07 11 34614 167586 42419124
Kidney infection 96.17 19.07 63 34562 6707 42580003
Neutropenia 94.40 19.07 23 34602 199408 42387302
Bone erosion 93.49 19.07 53 34572 4350 42582360
Pelvic pain 90.94 19.07 47 34578 3207 42583503
Pulmonary tuberculosis 90.09 19.07 56 34569 5445 42581265
Joint ankylosis 89.86 19.07 38 34587 1639 42585071
Terminal insomnia 89.02 19.07 32 34593 887 42585823
Gait inability 88.81 19.07 101 34524 22732 42563978
Inflammation 85.91 19.07 121 34504 33726 42552984
Tuberculosis 81.96 19.07 67 34558 10032 42576678
Neck pain 81.73 19.07 111 34514 29903 42556807
Device failure 80.65 19.07 41 34584 2702 42584008
Psoriasis 78.10 19.07 141 34484 48463 42538247
Disease progression 77.57 19.07 12 34613 143644 42443066
Thrombocytopenia 77.28 19.07 29 34596 190250 42396460
Hypotension 77.20 19.07 58 34567 257573 42329137
Off label use 75.65 19.07 820 33805 637515 41949195
Therapeutic product effect incomplete 74.99 19.07 173 34452 70766 42515944
Product storage error 72.25 19.07 65 34560 11075 42575635
Influenza 71.72 19.07 157 34468 62018 42524692
Platelet count decreased 71.66 19.07 13 34612 138568 42448142
Gastrointestinal infection 68.29 19.07 51 34574 6692 42580018
Bone cyst 64.58 19.07 30 34595 1621 42585089
Dehydration 63.90 19.07 18 34607 141749 42444961
Neuropathy peripheral 63.80 19.07 5 34620 101848 42484862
Injection site warmth 61.60 19.07 34 34591 2649 42584061
Osteoarthritis 61.56 19.07 87 34538 24318 42562392
Pregnancy of partner 61.08 19.07 20 34605 415 42586295
Drug abuse 60.72 19.07 7 34618 104764 42481946
Drug use disorder 60.61 19.07 57 34568 10276 42576434
Colectomy 60.40 19.07 32 34593 2297 42584413
Post procedural infection 59.14 19.07 44 34581 5741 42580969
Constipation 59.08 19.07 29 34596 162262 42424448
Injection site reaction 58.53 19.07 68 34557 15653 42571057
Anti-cyclic citrullinated peptide antibody positive 57.45 19.07 29 34596 1883 42584827
Red blood cell sedimentation rate 56.30 19.07 24 34601 1056 42585654
Hyponatraemia 55.85 19.07 8 34617 101454 42485256
Rheumatoid nodule 55.49 19.07 33 34592 2962 42583748
Somnolence 54.81 19.07 23 34602 141082 42445628
Vomiting 54.46 19.07 95 34530 289628 42297082
Granuloma skin 54.35 19.07 24 34601 1151 42585559
Hand deformity 53.36 19.07 35 34590 3733 42582977
Headache 52.90 19.07 354 34271 239015 42347695
Cardiac arrest 52.88 19.07 12 34613 109308 42477402
Multiple organ dysfunction syndrome 52.60 19.07 8 34617 97027 42489683
Colitis ulcerative 51.35 19.07 83 34542 26092 42560618
Skin injury 51.29 19.07 30 34595 2611 42584099
Seizure 51.27 19.07 17 34608 120544 42466166
Tachycardia 51.14 19.07 10 34615 101077 42485633
Hepatic steatosis 50.49 19.07 74 34551 21374 42565336
Respiratory failure 49.58 19.07 21 34604 128111 42458599
Panniculitis 48.32 19.07 27 34598 2154 42584556
Pain in extremity 47.69 19.07 245 34380 150359 42436351
Musculoskeletal pain 47.64 19.07 92 34533 33248 42553462
Mobility decreased 47.52 19.07 95 34530 35211 42551499
Dysphagia 47.18 19.07 3 34622 72716 42513994
Blood parathyroid hormone decreased 46.69 19.07 24 34601 1619 42585091
Diarrhoea haemorrhagic 46.14 19.07 43 34582 7664 42579046
Haematochezia 45.54 19.07 127 34498 58309 42528401
Hypoxia 44.92 19.07 3 34622 69783 42516927
White blood cell count decreased 44.49 19.07 17 34608 110379 42476331
Basal cell carcinoma 44.48 19.07 72 34553 22661 42564049
Malignant melanoma 44.26 19.07 46 34579 9354 42577356
Blood creatinine increased 44.23 19.07 17 34608 109986 42476724
Bradycardia 44.21 19.07 8 34617 85476 42501234
Pyrexia 44.14 19.07 168 34457 393874 42192836
Injection site mass 44.08 19.07 44 34581 8531 42578179
Pancreatic carcinoma 43.83 19.07 46 34579 9460 42577250
Loss of personal independence in daily activities 43.58 19.07 113 34512 49703 42537007
Oedema peripheral 42.84 19.07 29 34596 136047 42450663
Cellulitis 41.42 19.07 127 34498 61458 42525252
Pancytopenia 41.40 19.07 22 34603 117721 42468989
Rhabdomyolysis 41.01 19.07 7 34618 78012 42508698
Prostate cancer 40.84 19.07 103 34522 44540 42542170
Exostosis 40.81 19.07 35 34590 5596 42581114
Haemoglobin decreased 40.68 19.07 29 34596 132442 42454268
Osteolysis 40.61 19.07 29 34596 3551 42583159
Localised infection 40.50 19.07 65 34560 20308 42566402
Hypersensitivity 40.36 19.07 140 34485 72230 42514480
Herpes zoster 40.16 19.07 94 34531 38783 42547927
Iridocyclitis 40.02 19.07 24 34601 2187 42584523
Renal failure 38.50 19.07 36 34589 143690 42443020
Decreased appetite 38.41 19.07 61 34564 193076 42393634
Carbon dioxide abnormal 38.40 19.07 13 34612 300 42586410
Cardiac failure congestive 38.31 19.07 11 34614 85591 42501119
Drug tolerance 38.13 19.07 27 34598 3263 42583447
Skin cancer 36.81 19.07 46 34579 11416 42575294
Back pain 36.42 19.07 218 34407 141558 42445152
Cardio-respiratory arrest 36.37 19.07 3 34622 58633 42528077
C-reactive protein increased 36.35 19.07 124 34501 63436 42523274
Pharyngitis 35.71 19.07 40 34585 8850 42577860
Neutrophil count decreased 34.89 19.07 5 34620 63410 42523300
Angiolymphoid hyperplasia with eosinophilia 34.88 19.07 10 34615 130 42586580
Hypoglycaemia 34.66 19.07 4 34621 59850 42526860
Lymphoma 34.56 19.07 50 34575 14271 42572439
Inflammatory bowel disease 34.20 19.07 26 34599 3503 42583207
Atrial fibrillation 33.94 19.07 38 34587 139555 42447155
Gastric disorder 33.83 19.07 45 34580 11877 42574833
Lymphoproliferative disorder 33.46 19.07 25 34600 3282 42583428
Agitation 33.29 19.07 6 34619 64308 42522402
Dermatitis psoriasiform 33.23 19.07 21 34604 2101 42584609
Hallucination 32.91 19.07 4 34621 57503 42529207
Lyme disease 32.64 19.07 17 34608 1178 42585532
Latent tuberculosis 32.56 19.07 19 34606 1646 42585064
Hypokalaemia 32.49 19.07 9 34616 71712 42514998
Overdose 31.07 19.07 24 34601 105240 42481470
Septic shock 30.96 19.07 18 34607 91654 42495056
Lower respiratory tract congestion 30.61 19.07 18 34607 1582 42585128
Rheumatoid factor 30.37 19.07 8 34617 74 42586636
Therapy cessation 29.91 19.07 57 34568 20393 42566317
Tooth abscess 29.87 19.07 32 34593 6736 42579974
Administration site pain 29.66 19.07 12 34613 462 42586248
Intentional product misuse 29.51 19.07 7 34618 61893 42524817
Sacroiliitis 29.51 19.07 19 34606 1963 42584747
Knee arthroplasty 29.42 19.07 36 34589 8745 42577965
Anal abscess 29.29 19.07 34 34591 7816 42578894
Ocular hyperaemia 29.12 19.07 49 34576 15914 42570796
Hepatic fibrosis 28.81 19.07 27 34598 4845 42581865
Ileectomy 28.68 19.07 9 34616 162 42586548
Syringe issue 28.54 19.07 35 34590 8521 42578189
Tender joint count decreased 28.42 19.07 10 34615 260 42586450
Swollen joint count decreased 28.42 19.07 10 34615 260 42586450
Surgery 28.14 19.07 51 34574 17565 42569145
Spinal pain 28.07 19.07 31 34594 6751 42579959
Tonsillitis 28.02 19.07 21 34604 2770 42583940
Rheumatoid factor increased 27.97 19.07 13 34612 703 42586007
Lung neoplasm malignant 27.55 19.07 53 34572 19094 42567616
Bone hypertrophy 27.32 19.07 10 34615 292 42586418
SAPHO syndrome 27.32 19.07 11 34614 418 42586292
COVID-19 27.07 19.07 174 34451 115774 42470936
Tendon operation 26.27 19.07 7 34618 68 42586642
Suicidal ideation 26.02 19.07 4 34621 48157 42538553
Oral candidiasis 25.99 19.07 44 34581 14361 42572349
Injection site erythema 25.58 19.07 53 34572 20142 42566568
X-ray abnormal 25.44 19.07 11 34614 501 42586209
Respiratory tract infection 25.41 19.07 62 34563 26260 42560450
Burning sensation 25.28 19.07 54 34571 20959 42565751
Chest pain 25.04 19.07 47 34578 139483 42447227
Joint instability 24.84 19.07 11 34614 531 42586179
Leukopenia 24.78 19.07 15 34610 74731 42511979
Blood cholesterol abnormal 24.70 19.07 17 34608 1962 42584748
Wheezing 24.58 19.07 7 34618 54774 42531936
Suicide attempt 24.52 19.07 4 34621 46096 42540614
Blood glucose increased 24.14 19.07 15 34610 73684 42513026
Blood creatine phosphokinase increased 23.98 19.07 5 34620 48333 42538377
Drug reaction with eosinophilia and systemic symptoms 23.90 19.07 3 34622 42072 42544638
Coma 23.74 19.07 7 34618 53547 42533163
Pulmonary embolism 23.54 19.07 38 34587 119574 42467136
Incorrect dose administered 23.30 19.07 95 34530 52879 42533831
Penile cancer 22.73 19.07 8 34617 208 42586502
Bladder transitional cell carcinoma stage II 22.73 19.07 6 34619 56 42586654
Pneumonia legionella 22.62 19.07 17 34608 2251 42584459
Lymph gland infection 22.52 19.07 8 34617 214 42586496
Ileostomy 22.51 19.07 13 34612 1105 42585605
Foot deformity 22.43 19.07 24 34601 5044 42581666
Tendon disorder 22.42 19.07 20 34605 3369 42583341
Neoplasm malignant 22.41 19.07 54 34571 22689 42564021
Fear of injection 22.20 19.07 16 34609 1987 42584723
Ear neoplasm 21.76 19.07 6 34619 67 42586643
Demyelination 21.72 19.07 20 34605 3509 42583201
Influenza like illness 21.71 19.07 66 34559 31774 42554936
No adverse event 21.64 19.07 3 34622 39018 42547692
Lipids increased 21.53 19.07 13 34612 1199 42585511
Loss of consciousness 21.51 19.07 26 34599 92328 42494382
Drug dependence 21.45 19.07 62 34563 29032 42557678
Respiratory distress 21.43 19.07 4 34621 41816 42544894
Pneumonia aspiration 21.38 19.07 7 34618 50071 42536639
Disseminated tuberculosis 21.38 19.07 18 34607 2806 42583904
Nodal osteoarthritis 21.38 19.07 8 34617 249 42586461
Epistaxis 21.34 19.07 14 34611 66812 42519898
Antisynthetase syndrome 21.30 19.07 7 34618 147 42586563
Gastrointestinal haemorrhage 21.22 19.07 29 34596 97697 42489013
Arthritis bacterial 21.20 19.07 25 34600 5843 42580867
Onycholysis 21.07 19.07 12 34613 993 42585717
Bronchitis 21.04 19.07 85 34540 47116 42539594
Syphilis 20.99 19.07 10 34615 572 42586138
Knee operation 20.52 19.07 17 34608 2591 42584119
Tonsillar disorder 20.47 19.07 9 34616 427 42586283
Frequent bowel movements 20.21 19.07 50 34575 21357 42565353
Syncope 20.11 19.07 31 34594 99375 42487335
Renal impairment 19.89 19.07 37 34588 110191 42476519
Skin necrosis 19.73 19.07 25 34600 6289 42580421
Chronic kidney disease 19.48 19.07 7 34618 47234 42539476
Proctocolectomy 19.34 19.07 7 34618 198 42586512
Joint space narrowing 19.30 19.07 7 34618 199 42586511
Therapy non-responder 19.13 19.07 90 34535 53269 42533441

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
Synovitis 2964.16 21.92 4240 391161 269852 109924046
Pemphigus 2576.79 21.92 3492 391909 211078 109982820
Joint swelling 2561.88 21.92 5182 390219 437663 109756235
Contraindicated product administered 2554.44 21.92 3752 391649 244515 109949383
Hand deformity 2518.27 21.92 3486 391915 215020 109978878
Systemic lupus erythematosus 2428.58 21.92 3712 391689 250626 109943272
Glossodynia 2401.36 21.92 3436 391965 218568 109975330
Drug intolerance 2300.66 21.92 4715 390686 401797 109792101
Therapeutic product effect decreased 2284.99 21.92 3532 391869 240784 109953114
Anti-cyclic citrullinated peptide antibody positive 2137.72 21.92 2931 392470 179053 110014845
Arthropathy 2120.94 21.92 3735 391666 283787 109910111
Wound 2083.43 21.92 3311 392090 231126 109962772
Pericarditis 1994.44 21.92 3129 392272 215985 109977913
Swelling 1961.95 21.92 4052 391349 346989 109846909
Acute kidney injury 1819.73 21.92 115 395286 635315 109558583
Alopecia 1779.50 21.92 3985 391416 360768 109833130
Treatment failure 1674.29 21.92 3306 392095 273928 109919970
Helicobacter infection 1601.64 21.92 2559 392842 179318 110014580
Duodenal ulcer perforation 1549.34 21.92 2489 392912 175211 110018687
Drug interaction 1545.67 21.92 55 395346 500128 109693770
Rheumatoid factor positive 1516.18 21.92 2101 393300 129539 110064359
Folliculitis 1501.04 21.92 2377 393024 165276 110028622
Toxicity to various agents 1491.33 21.92 51 395350 480504 109713394
Abdominal discomfort 1486.84 21.92 3898 391503 389960 109803938
Anaemia 1477.83 21.92 130 395271 546956 109646942
Lower respiratory tract infection 1467.41 21.92 2899 392502 240207 109953691
Irritable bowel syndrome 1436.78 21.92 2304 393097 161911 110031987
Hypersensitivity 1422.78 21.92 3897 391504 400101 109793797
Discomfort 1367.04 21.92 2619 392782 212088 109981810
Muscle injury 1340.57 21.92 2054 393347 138753 110055145
Hepatic enzyme increased 1339.64 21.92 3300 392101 317592 109876306
Death 1287.81 21.92 447 394954 698422 109495476
Impaired healing 1255.17 21.92 2402 392999 194315 109999583
Sleep disorder due to general medical condition, insomnia type 1192.18 21.92 1670 393731 103973 110089925
Hypotension 1191.73 21.92 217 395184 523632 109670266
Psoriatic arthropathy 1171.97 21.92 2334 393067 194427 109999471
Blister 1132.89 21.92 2507 392894 224869 109969029
Neutropenia 1130.43 21.92 49 395352 374571 109819327
Musculoskeletal stiffness 1109.02 21.92 2822 392579 277000 109916898
Febrile neutropenia 1091.57 21.92 7 395394 316760 109877138
Rheumatic fever 1078.88 21.92 1725 393676 120854 110073044
Ill-defined disorder 1064.67 21.92 1967 393434 154886 110039012
Infusion related reaction 1057.22 21.92 3379 392022 377783 109816115
Device deployment issue 985.89 21.92 419 394982 3834 110190064
Product use issue 933.97 21.92 2839 392562 308856 109885042
Drug ineffective 930.34 21.92 8883 386518 1511657 108682241
C-reactive protein abnormal 918.71 21.92 1657 393744 128038 110065860
Type 2 diabetes mellitus 916.39 21.92 1984 393417 175248 110018650
Constipation 886.49 21.92 116 395285 357670 109836228
Sinusitis 869.83 21.92 2682 392719 294006 109899892
Fibromyalgia 865.13 21.92 1897 393504 169012 110024886
Completed suicide 842.04 21.92 4 395397 242377 109951521
Mobility decreased 816.23 21.92 2272 393129 235150 109958748
Infection 804.68 21.92 2983 392418 359217 109834681
Peripheral swelling 802.37 21.92 3211 392190 400823 109793075
Maternal exposure during pregnancy 787.21 21.92 2347 393054 252536 109941362
Swollen joint count increased 785.38 21.92 1213 394188 82448 110111450
Stomatitis 768.93 21.92 2418 392983 267824 109926074
Thrombocytopenia 756.22 21.92 162 395239 348723 109845175
Dehydration 744.35 21.92 70 395331 279441 109914457
Rheumatoid arthritis 731.23 21.92 2545 392856 297068 109896830
Inflammation 717.86 21.92 1903 393498 191335 110002563
Pain 712.66 21.92 5833 389568 949122 109244776
Hyponatraemia 682.06 21.92 21 395380 217632 109976266
Disease progression 677.56 21.92 51 395350 243983 109949915
Gastrointestinal disorder 674.54 21.92 2150 393251 239802 109954096
Blood cholesterol increased 674.48 21.92 1808 393593 182977 110010921
Somnolence 663.48 21.92 129 395272 297320 109896578
Arthralgia 658.95 21.92 4903 390498 774729 109419169
Cardiac arrest 647.34 21.92 11 395390 196742 109997156
Facet joint syndrome 618.98 21.92 1184 394217 95644 110098254
Joint range of motion decreased 606.91 21.92 1344 394057 120488 110073410
Lip dry 599.86 21.92 1191 394210 98892 110095006
Injury 598.76 21.92 1686 393715 175579 110018319
Drug abuse 596.27 21.92 7 395394 177404 110016494
Night sweats 585.84 21.92 1404 393997 132579 110061319
Respiratory failure 575.72 21.92 53 395348 215279 109978619
Sepsis 572.21 21.92 227 395174 327119 109866779
Platelet count decreased 558.06 21.92 80 395321 230363 109963535
Renal failure 557.30 21.92 75 395326 226499 109967399
Liver injury 551.09 21.92 1474 393927 148939 110044959
Nasopharyngitis 537.48 21.92 2806 392595 391555 109802343
Pancytopenia 528.58 21.92 64 395337 209549 109984349
Seizure 528.18 21.92 80 395321 221105 109972793
Grip strength decreased 511.95 21.92 980 394421 79194 110114704
Cough 508.78 21.92 540 394861 461101 109732797
Sciatica 492.88 21.92 1048 394353 91351 110102547
Peripheral venous disease 490.86 21.92 990 394411 83127 110110771
Haemoglobin decreased 489.33 21.92 141 395260 248586 109945312
Bradycardia 476.65 21.92 18 395383 155499 110038399
Knee arthroplasty 466.28 21.92 835 394566 64113 110129785
Multiple organ dysfunction syndrome 456.76 21.92 20 395381 151690 110042208
Osteoarthritis 451.79 21.92 1559 393842 181064 110012834
Cardiac failure 438.60 21.92 72 395329 187554 110006344
Hip arthroplasty 435.00 21.92 744 394657 55069 110138829
Rash 434.86 21.92 4664 390737 816300 109377598
Pulmonary embolism 434.18 21.92 115 395286 214359 109979539
Hyperhidrosis 433.11 21.92 74 395327 187224 110006674
Bursitis 429.12 21.92 1226 394175 128692 110065206
Gastrointestinal haemorrhage 428.66 21.92 46 395355 165472 110028426
Tremor 421.78 21.92 102 395299 202130 109991768
Adverse event 420.58 21.92 1088 394313 107721 110086177
Hypoxia 418.86 21.92 9 395392 129506 110064392
Fall 409.97 21.92 975 394426 602507 109591391
Gait inability 407.57 21.92 1242 394159 135134 110058764
Renal impairment 405.04 21.92 89 395312 188356 110005542
Cardiac failure congestive 398.72 21.92 39 395362 150961 110042937
Chest discomfort 396.92 21.92 71 395330 173777 110020121
Red blood cell sedimentation rate increased 396.85 21.92 870 394531 77432 110116466
Breast cancer stage III 396.39 21.92 875 394526 78242 110115656
Wound infection 396.17 21.92 987 394414 95478 110098420
Atrial fibrillation 393.45 21.92 164 395237 229478 109964420
Lower limb fracture 393.07 21.92 847 394554 74501 110119397
Rhabdomyolysis 390.82 21.92 8 395393 120393 110073505
White blood cell count decreased 387.92 21.92 167 395234 229223 109964675
Cardio-respiratory arrest 387.29 21.92 5 395396 115831 110078067
Sleep disorder 383.38 21.92 1566 393835 197078 109996820
Musculoskeletal pain 377.37 21.92 1473 393928 181550 110012348
Contusion 373.52 21.92 1739 393662 231622 109962276
Foot deformity 369.60 21.92 640 394761 47840 110146058
Obesity 367.86 21.92 1063 394338 112288 110081610
Nail disorder 367.17 21.92 706 394695 57229 110136669
Oxygen saturation decreased 365.21 21.92 61 395340 156921 110036977
Neuropathy peripheral 365.00 21.92 95 395306 179182 110014716
Hypoglycaemia 364.39 21.92 11 395390 116093 110077805
Bone erosion 358.55 21.92 616 394785 45755 110148143
Drug hypersensitivity 357.92 21.92 2812 392589 451278 109742620
Coma 356.60 21.92 15 395386 117854 110076044
Depressed level of consciousness 354.71 21.92 10 395391 112268 110081630
Dysphagia 354.43 21.92 61 395340 153539 110040359
Deep vein thrombosis postoperative 353.27 21.92 704 394697 58587 110135311
Neutrophil count decreased 351.16 21.92 20 395381 120921 110072977
Agitation 350.19 21.92 12 395389 113039 110080859
Onychomadesis 348.36 21.92 603 394798 45060 110148838
Hypercholesterolaemia 345.59 21.92 903 394498 89934 110103964
Dyspnoea 339.94 21.92 2441 392960 1104431 109089467
Tachycardia 336.63 21.92 196 395205 226449 109967449
Blood creatinine increased 335.94 21.92 117 395284 182772 110011126
Suicide attempt 320.18 21.92 11 395390 103383 110090515
Cerebrovascular accident 312.88 21.92 128 395273 181156 110012742
Dislocation of vertebra 309.83 21.92 559 394842 43162 110150736
Needle issue 308.03 21.92 349 395052 17491 110176407
Epistaxis 306.97 21.92 49 395352 130323 110063575
Hypokalaemia 305.00 21.92 135 395266 182313 110011585
Weight increased 298.39 21.92 2539 392862 417105 109776793
Vision blurred 298.20 21.92 51 395350 128971 110064927
Onychomycosis 296.77 21.92 511 394890 38020 110155878
International normalised ratio increased 293.45 21.92 3 395398 86769 110107129
Road traffic accident 292.23 21.92 947 394454 106451 110087447
Blood pressure increased 290.26 21.92 297 395104 258076 109935822
Autoimmune disorder 289.08 21.92 689 394712 64794 110129104
Chills 287.02 21.92 162 395239 190418 110003480
Ascites 283.48 21.92 11 395390 92797 110101101
Overdose 283.37 21.92 251 395150 233543 109960355
Dyspnoea exertional 282.43 21.92 24 395377 104036 110089862
Syncope 280.29 21.92 190 395211 202346 109991552
Myelosuppression 278.89 21.92 14 395387 94326 110099572
Hyperglycaemia 278.80 21.92 5 395396 85085 110108813
General physical health deterioration 277.91 21.92 2526 392875 422769 109771129
Urticaria 277.68 21.92 2022 393379 316835 109877063
Product dose omission issue 274.77 21.92 2031 393370 319751 109874147
Adjustment disorder with depressed mood 274.67 21.92 532 394869 43351 110150547
Balance disorder 274 21.92 44 395357 116516 110077382
Pleural effusion 273.51 21.92 147 395254 177562 110016336
Pulmonary fibrosis 273.34 21.92 895 394506 101147 110092751
Drug reaction with eosinophilia and systemic symptoms 272.45 21.92 4 395397 82091 110111807
Therapeutic product effect incomplete 272.39 21.92 1545 393856 222260 109971638
Myalgia 270.42 21.92 238 395163 222143 109971755
Dysarthria 267.55 21.92 7 395394 84114 110109784
Palpitations 267.40 21.92 117 395284 159095 110034803
Blood pressure decreased 262.69 21.92 47 395354 115044 110078854
C-reactive protein increased 261.68 21.92 1499 393902 216420 109977478
Blood glucose increased 260.69 21.92 75 395326 132421 110061477
Live birth 260.47 21.92 687 394714 68797 110125101
Encephalopathy 253.19 21.92 8 395393 81047 110112851
Hallucination 245.96 21.92 35 395366 101397 110092501
Ankylosing spondylitis 245.39 21.92 291 395110 15321 110178577
Mental status changes 243.37 21.92 6 395395 76116 110117782
Leukopenia 242.60 21.92 114 395287 148677 110045221
Intentional product use issue 239.18 21.92 1612 393789 246294 109947604
Rheumatoid nodule 237.93 21.92 327 395074 19969 110173929
Dry mouth 237.18 21.92 1371 394030 198577 109995321
Loss of personal independence in daily activities 235.53 21.92 1112 394289 148908 110044990
Feeling abnormal 235.07 21.92 181 395220 180530 110013368
Septic shock 231.37 21.92 138 395263 157390 110036508
Drug delivery system malfunction 230.09 21.92 99 395302 936 110192962
Cognitive disorder 229.96 21.92 23 395378 87488 110106410
X-ray abnormal 228.74 21.92 454 394947 37663 110156235
Injury associated with device 227.24 21.92 160 395241 4229 110189669
Chronic kidney disease 226.54 21.92 11 395390 76280 110117618
Intentional product misuse 225.83 21.92 96 395305 132808 110061090
Pneumonia aspiration 225.29 21.92 17 395384 81216 110112682
Mucosal inflammation 224.39 21.92 37 395364 96104 110097794
Injection site pain 221.68 21.92 186 395215 177736 110016162
Nausea 221.60 21.92 3101 392300 1232589 108961309
Pulmonary oedema 221.46 21.92 45 395356 100614 110093284
Myocardial infarction 221.20 21.92 216 395185 191867 110002031
Blood creatine phosphokinase increased 218.73 21.92 10 395391 73067 110120831
Haematuria 215.05 21.92 23 395378 82982 110110916
Neoplasm progression 214.99 21.92 3 395398 64592 110129306
Drug tolerance decreased 214.40 21.92 367 395034 27173 110166725
Blood bilirubin increased 213.27 21.92 15 395386 75957 110117941
Unresponsive to stimuli 212.15 21.92 3 395398 63787 110130111
Liver disorder 211.48 21.92 1038 394363 141205 110052693
Chronic obstructive pulmonary disease 210.71 21.92 64 395337 109094 110084804
Disorientation 210.46 21.92 10 395391 70661 110123237
Blepharospasm 209.33 21.92 546 394855 54305 110139593
Coronary artery disease 207.66 21.92 12 395389 71678 110122220
Blood alkaline phosphatase increased 205.08 21.92 12 395389 70923 110122975
Arthritis 204.56 21.92 1158 394243 166428 110027470
Hypoaesthesia 203.91 21.92 1864 393537 312359 109881539
Heart rate increased 202.94 21.92 132 395269 143702 110050196
Exostosis 200.08 21.92 481 394920 45475 110148423
Acute respiratory failure 199.80 21.92 19 395382 75241 110118657
Dry skin 199.15 21.92 68 395333 107585 110086313
Cholestasis 195.85 21.92 8 395393 64510 110129388
Respiratory distress 195.08 21.92 13 395388 68861 110125037
Agranulocytosis 193.24 21.92 6 395395 61754 110132144
Lung disorder 192.72 21.92 1202 394199 178845 110015053
Hepatic function abnormal 192.17 21.92 42 395359 89253 110104645
Wheezing 191.71 21.92 1564 393837 253666 109940232
Angioedema 189.67 21.92 58 395343 98442 110095456
Orthostatic hypotension 189.14 21.92 12 395389 66237 110127661
Suicidal ideation 188.84 21.92 51 395350 93886 110100012
Jaundice 188.12 21.92 5 395396 59231 110134667
Retinitis 187.94 21.92 380 395021 31947 110161951
Disturbance in attention 187.14 21.92 8 395393 61987 110131911
Hepatic failure 186.13 21.92 16 395385 68723 110125175
C-reactive protein 185.30 21.92 364 395037 29967 110163931
Acute myocardial infarction 185.25 21.92 37 395364 83740 110110158
Hypothyroidism 184.33 21.92 22 395379 72877 110121021
Haemoptysis 184.27 21.92 20 395381 71334 110122564
Prescribed overdose 183.74 21.92 709 394692 86872 110107026
Skin exfoliation 181.14 21.92 45 395356 87606 110106292
Flushing 180.60 21.92 74 395327 104662 110089236
Dysgeusia 179.76 21.92 20 395381 69965 110123933
Coeliac disease 179.47 21.92 444 394957 42743 110151155
Lupus vulgaris 179.08 21.92 383 395018 33500 110160398
Heart rate decreased 177.94 21.92 39 395362 82717 110111181
Product label confusion 177.59 21.92 303 395098 22374 110171524
Erythema 177.47 21.92 497 394904 290950 109902948
Enthesopathy 177.28 21.92 221 395180 12257 110181641
Anti-cyclic citrullinated peptide antibody 176.88 21.92 282 395119 19682 110174216
Aphasia 176.81 21.92 8 395393 58989 110134909
Bone marrow failure 176.18 21.92 7 395394 57841 110136057
Melaena 175.72 21.92 20 395381 68737 110125161
Deep vein thrombosis 174.54 21.92 146 395255 139741 110054157
Device defective 174.28 21.92 129 395272 3693 110190205
Restlessness 174.12 21.92 6 395395 56253 110137645
Urinary retention 173.82 21.92 22 395379 69661 110124237
Blood urea increased 173.18 21.92 5 395396 54952 110138946
Shock 172.17 21.92 4 395397 53584 110140314
Back injury 171.92 21.92 463 394938 46936 110146962
Lymphocyte count decreased 170.78 21.92 8 395393 57235 110136663
Blood parathyroid hormone decreased 170.45 21.92 222 395179 12867 110181031
Haematocrit decreased 169.55 21.92 19 395382 66098 110127800
Hypophagia 168.80 21.92 4 395397 52622 110141276
Granuloma skin 168.63 21.92 205 395196 11078 110182820
Psychotic disorder 166.84 21.92 3 395398 50934 110142964
Gamma-glutamyltransferase increased 166.74 21.92 14 395387 61295 110132603
Ear pain 166.70 21.92 493 394908 52733 110141165
Weight decreased 166.49 21.92 986 394415 467071 109726827
Lethargy 166.47 21.92 63 395338 93513 110100385
Hypomagnesaemia 166.37 21.92 13 395388 60357 110133541
Altered state of consciousness 165.83 21.92 10 395391 57616 110136282
Drug ineffective for unapproved indication 165.78 21.92 80 395321 102758 110091140
Generalised tonic-clonic seizure 165.24 21.92 7 395394 54673 110139225
Joint stiffness 164.34 21.92 572 394829 66671 110127227
Tenosynovitis 163.91 21.92 244 395157 16039 110177859
Ventricular tachycardia 163.58 21.92 3 395398 50006 110143892
Rash erythematous 163.42 21.92 45 395356 81787 110112111
Oropharyngeal pain 162.93 21.92 146 395255 135130 110058768
Aggression 162.48 21.92 13 395388 59197 110134701
Hypervolaemia 161.65 21.92 3 395398 49457 110144441
Haemorrhage 161.60 21.92 90 395311 106602 110087296
Diarrhoea 161.21 21.92 2988 392413 1136517 109057381
Panniculitis 160.45 21.92 236 395165 15346 110178552
Leukocytosis 159.06 21.92 8 395393 53820 110140078
Thrombosis 158.41 21.92 96 395305 108566 110085332
Lupus-like syndrome 157.65 21.92 408 394993 40384 110153514
Hepatic cytolysis 157.08 21.92 10 395391 55043 110138855
Seronegative arthritis 157.02 21.92 214 395187 12963 110180935
Upper gastrointestinal haemorrhage 156.26 21.92 5 395396 50091 110143807
Loss of consciousness 154.00 21.92 292 395109 196014 109997884
Wrong technique in product usage process 153.41 21.92 60 395341 87288 110106610
Hot flush 152.80 21.92 26 395375 66010 110127888
Prescribed underdose 152.06 21.92 546 394855 64628 110129270
Pallor 150.58 21.92 14 395387 56453 110137445
Laryngitis 149.54 21.92 410 394991 42001 110151897
Device malfunction 149.25 21.92 301 395100 25257 110168641
Adverse drug reaction 147.48 21.92 757 394644 104802 110089096
Device issue 146.63 21.92 358 395043 34177 110159721
Rash maculo-papular 144.18 21.92 43 395358 74179 110119719
Pulmonary hypertension 143.82 21.92 15 395386 55205 110138693
Finger deformity 143.67 21.92 346 395055 32746 110161152
Red blood cell sedimentation rate abnormal 143.55 21.92 289 395112 24220 110169678
Cerebral haemorrhage 143.00 21.92 29 395372 64939 110128959
Productive cough 142.97 21.92 119 395282 114186 110079712
Colitis 142.85 21.92 95 395306 102228 110091670
Exposure during pregnancy 140.60 21.92 1053 394348 166371 110027527
Pancreatitis acute 138.87 21.92 24 395377 60250 110133648
Stevens-Johnson syndrome 138.49 21.92 7 395394 46894 110147004
Pregnancy 137.69 21.92 449 394952 50618 110143280
Arrhythmia 137.55 21.92 39 395362 69536 110124362
Lip swelling 136.62 21.92 12 395389 50655 110143243
Dyskinesia 136.53 21.92 13 395388 51433 110142465
Blood lactate dehydrogenase increased 136.26 21.92 5 395396 44329 110149569
Drug tolerance 135.71 21.92 226 395175 16359 110177539
Taste disorder 134.43 21.92 526 394875 64861 110129037
Transient ischaemic attack 133.87 21.92 32 395369 63950 110129948
Eosinophilia 133.64 21.92 23 395378 57913 110135985
Sinus tachycardia 133.44 21.92 6 395395 44487 110149411
Adverse reaction 133.42 21.92 314 395087 29280 110164618
Haematemesis 133.01 21.92 25 395376 59083 110134815
Tubulointerstitial nephritis 130.97 21.92 19 395382 54265 110139633
Joint dislocation 129.08 21.92 339 395062 33851 110160047
Coagulopathy 127.90 21.92 4 395397 40907 110152991
Ejection fraction decreased 127.79 21.92 4 395397 40876 110153022
Vertigo 127.68 21.92 76 395325 86794 110107104
Injection site swelling 127.14 21.92 32 395369 61758 110132140
Plasma cell myeloma 126.81 21.92 34 395367 62902 110130996
Abdominal pain upper 126.20 21.92 1849 393552 347262 109846636
Blood pressure fluctuation 125.58 21.92 55 395346 74769 110119129
Accidental overdose 125.39 21.92 18 395383 51816 110142082
Pericardial effusion 124.98 21.92 26 395375 57191 110136707
Nightmare 124.47 21.92 3 395398 38860 110155038
Liver function test increased 123.69 21.92 635 394766 87913 110105985
Lymphopenia 121.86 21.92 5 395396 40165 110153733
Injection site reaction 121.13 21.92 634 394767 88436 110105462
Cholelithiasis 120.93 21.92 38 395363 63384 110130514
Acute respiratory distress syndrome 120.79 21.92 22 395379 53176 110140722
Neck pain 119.44 21.92 802 394599 122328 110071570
Respiratory disorder 118.53 21.92 538 394863 70844 110123054
Maternal exposure timing unspecified 117.41 21.92 243 395158 20770 110173128
Haematoma 117.05 21.92 32 395369 58444 110135454
Depressed mood 116.72 21.92 36 395365 60773 110133125
Angina pectoris 115.82 21.92 39 395362 62256 110131642
Hepatocellular injury 114.86 21.92 21 395380 50621 110143277
Underdose 114.62 21.92 491 394910 63063 110130835
Blood calcium decreased 113.92 21.92 3 395398 35842 110158056
Clostridium difficile colitis 113.73 21.92 12 395389 43766 110150132
Pyrexia 113.33 21.92 2400 393001 895865 109298033
Cardiac disorder 113.14 21.92 66 395335 76214 110117684
Eczema 112.37 21.92 59 395342 72234 110121664
Therapy non-responder 111.65 21.92 952 394449 156355 110037543
Presyncope 111.46 21.92 20 395381 48867 110145031
Blood potassium decreased 111.39 21.92 28 395373 54086 110139812
Osteonecrosis of jaw 110.89 21.92 19 395382 47998 110145900
Urinary tract infection 110.88 21.92 697 394704 325585 109868313
Disseminated intravascular coagulation 110.72 21.92 10 395391 41276 110152622
Ischaemic stroke 110.64 21.92 10 395391 41253 110152645
Muscle spasticity 109.94 21.92 330 395071 35585 110158313
Subdural haematoma 109.05 21.92 5 395396 36449 110157449
Circulatory collapse 108.63 21.92 13 395388 42980 110150918
Renal disorder 107.01 21.92 23 395378 49456 110144442
Myelodysplastic syndrome 106.38 21.92 7 395394 37477 110156421
Sopor 106.20 21.92 6 395395 36540 110157358
Bone pain 106.00 21.92 50 395351 65083 110128815
Hepatic cirrhosis 105.87 21.92 501 394900 67125 110126773
Blood potassium increased 104.86 21.92 3 395398 33246 110160652
Insomnia 104.85 21.92 1842 393559 358748 109835150
Urinary incontinence 104.24 21.92 23 395378 48564 110145334
Pneumonitis 104.22 21.92 73 395328 76458 110117440
Red blood cell sedimentation rate 103.91 21.92 110 395291 5104 110188794
Irritability 103.86 21.92 22 395379 47787 110146111
Rash macular 102.07 21.92 10 395391 38676 110155222
Liver function test abnormal 101.78 21.92 60 395341 68890 110125008
Tinnitus 100.81 21.92 45 395356 60495 110133403
Red blood cell count decreased 99.26 21.92 56 395345 65867 110128031
Cardiomyopathy 99.00 21.92 5 395396 33520 110160378
Throat irritation 98.74 21.92 34 395367 53518 110140380
Therapeutic response decreased 98.71 21.92 637 394764 95862 110098036
Blood sodium decreased 98.28 21.92 11 395390 38308 110155590
Abdominal pain 98.11 21.92 1269 394132 511720 109682178
Hemiparesis 97.87 21.92 19 395382 43884 110150014
Dysuria 96.85 21.92 47 395354 60184 110133714
Product quality issue 96.82 21.92 538 394863 76761 110117137
Neutrophil count increased 96.80 21.92 7 395394 34645 110159253
Transaminases increased 96.67 21.92 53 395348 63337 110130561
Uveitis 96.40 21.92 229 395172 21481 110172417
Oedema 96.12 21.92 1161 394240 208815 109985083
Walking aid user 96.06 21.92 250 395151 24825 110169073
Skin discolouration 96.02 21.92 28 395373 49018 110144880
Device dislocation 95.99 21.92 4 395397 31700 110162198
Accidental exposure to product 95.36 21.92 393 395008 49615 110144283
Dizziness 95.27 21.92 1841 393560 696352 109497546
Bacteraemia 95.23 21.92 18 395383 42372 110151526
Nasal congestion 95.21 21.92 127 395274 98155 110095743
Abdominal pain lower 94.88 21.92 11 395390 37272 110156626
Myoclonus 94.12 21.92 6 395395 32992 110160906
Head injury 93.03 21.92 20 395381 42997 110150901
Cytomegalovirus infection 92.99 21.92 39 395362 54405 110139493
Injection site erythema 92.97 21.92 120 395281 94056 110099842
Vomiting 92.79 21.92 2513 392888 908162 109285736
Neutropenic sepsis 92.69 21.92 4 395397 30742 110163156
Hyperlipidaemia 92.68 21.92 10 395391 35838 110158060
Blood pressure systolic increased 92.45 21.92 96 395305 82895 110111003
Cerebral infarction 92.03 21.92 35 395366 51803 110142095
Alanine aminotransferase abnormal 91.28 21.92 138 395263 9196 110184702
Flatulence 91.27 21.92 36 395365 52113 110141785
Thrombotic microangiopathy 90.59 21.92 3 395398 29146 110164752
Cytopenia 90.52 21.92 4 395397 30112 110163786
Haemorrhage intracranial 89.96 21.92 3 395398 28966 110164932
Muscle twitching 89.90 21.92 4 395397 29931 110163967
Diplopia 89.54 21.92 20 395381 41874 110152024
Intestinal obstruction 89.52 21.92 39 395362 53188 110140710
Oedema peripheral 89.45 21.92 748 394653 327912 109865986
Anxiety 88.75 21.92 797 394604 344281 109849617
Condition aggravated 88.62 21.92 3336 392065 731500 109462398
Metastases to bone 88.61 21.92 6 395395 31366 110162532
Migraine 88.36 21.92 971 394430 170681 110023217
Skin necrosis 88.15 21.92 220 395181 21292 110172606
Paraesthesia oral 88.06 21.92 9 395392 33662 110160236
Face oedema 87.39 21.92 9 395392 33460 110160438
Impaired quality of life 87.00 21.92 5 395396 30012 110163886
Lymphadenopathy 85.47 21.92 62 395339 63773 110130125
Tongue disorder 85.41 21.92 170 395231 14128 110179770
Chromaturia 84.77 21.92 5 395396 29355 110164543
Nervous system disorder 84.22 21.92 8 395393 31713 110162185
Emotional distress 83.51 21.92 28 395373 44819 110149079
Blood albumin decreased 82.05 21.92 4 395397 27648 110166250
Faeces discoloured 81.63 21.92 12 395389 33936 110159962
Breast cancer stage II 81.41 21.92 249 395152 27126 110166772
Gastric ulcer 81.22 21.92 21 395380 39806 110154092
Porphyria acute 81.13 21.92 196 395205 18584 110175314
Haemophagocytic lymphohistiocytosis 81.09 21.92 9 395392 31550 110162348
Hallucination, auditory 81.04 21.92 3 395398 26394 110167504
Shock haemorrhagic 80.66 21.92 4 395397 27243 110166655
Heart rate irregular 80.39 21.92 13 395388 34261 110159637
Cyanosis 80.30 21.92 7 395394 29734 110164164
Administration site pain 80.27 21.92 45 395356 786 110193112
Full blood count abnormal 79.64 21.92 51 395350 56001 110137897
Bronchospasm 79.30 21.92 8 395393 30231 110163667
Neuralgia 79.21 21.92 37 395364 48441 110145457
Hypertension 79.06 21.92 2385 393016 507699 109686199
Swelling face 78.07 21.92 131 395270 92190 110101708
Nervousness 77.94 21.92 18 395383 36833 110157065
Acute myeloid leukaemia 77.90 21.92 20 395381 38090 110155808
Eye pruritus 77.85 21.92 12 395389 32763 110161135
Confusional state 77.70 21.92 2210 393191 466470 109727428
Disease recurrence 77.59 21.92 62 395339 60722 110133176
Ear infection 77.49 21.92 435 394966 62297 110131601
Pain in jaw 76.30 21.92 44 395357 51133 110142765
Myopathy 76.07 21.92 3 395398 24957 110168941
Visual acuity reduced 75.92 21.92 12 395389 32161 110161737
Osteoporosis 75.89 21.92 553 394848 86599 110107299
Fluid retention 75.06 21.92 139 395262 94168 110099730
Panic attack 75.01 21.92 8 395393 28932 110164966
Therapy partial responder 74.71 21.92 20 395381 37041 110156857
Transfusion 74.58 21.92 4 395397 25468 110168430
Splenomegaly 74.48 21.92 3 395398 24495 110169403
Interstitial lung disease 73.83 21.92 253 395148 139081 110054817
Joint destruction 73.83 21.92 137 395264 10806 110183092
Atrial flutter 73.66 21.92 3 395398 24259 110169639
Blood iron abnormal 73.65 21.92 53 395348 1451 110192447
Ileus 73.57 21.92 11 395390 30718 110163180
Metastases to liver 73.43 21.92 18 395383 35368 110158530
Respiratory rate increased 73.25 21.92 4 395397 25079 110168819
Hypoalbuminaemia 72.62 21.92 9 395392 28965 110164933
Memory impairment 71.84 21.92 1045 394356 195899 109997999
Pseudomonas infection 71.42 21.92 8 395393 27845 110166053
Mental disorder 70.88 21.92 25 395376 38766 110155132
Bronchopulmonary aspergillosis 70.78 21.92 11 395390 29852 110164046
Cardiomegaly 70.73 21.92 10 395391 29120 110164778
Pruritus 70.71 21.92 2643 392758 578917 109614981
Aplastic anaemia 70.61 21.92 4 395397 24304 110169594
Hypersomnia 69.64 21.92 9 395392 28052 110165846
Blood glucose decreased 69.58 21.92 11 395390 29477 110164421
Gout 69.55 21.92 22 395379 36544 110157354
Rales 69.10 21.92 5 395396 24734 110169164
Mitral valve incompetence 69.07 21.92 17 395384 33312 110160586
Polyneuropathy 68.99 21.92 15 395386 31997 110161901
Pollakiuria 68.78 21.92 36 395365 44159 110149739
Kidney infection 68.03 21.92 224 395177 25375 110168523
Systemic lupus erythematosus rash 67.61 21.92 57 395344 1978 110191920
Illness 67.29 21.92 119 395282 82052 110111846
Hypocalcaemia 66.91 21.92 81 395320 65285 110128613
Fear 66.81 21.92 4 395397 23189 110170709
Dysphonia 66.77 21.92 105 395296 75824 110118074
Hyperthyroidism 66.65 21.92 12 395389 29249 110164649
Subarachnoid haemorrhage 65.90 21.92 13 395388 29689 110164209
Transplant rejection 65.74 21.92 6 395395 24561 110169337
Small intestinal obstruction 65.66 21.92 17 395384 32196 110161702
Device leakage 65.63 21.92 164 395237 15884 110178014
Speech disorder 65.49 21.92 74 395327 61495 110132403
Feeling cold 65.44 21.92 20 395381 33967 110159931
Disability 65.28 21.92 247 395154 29976 110163922
Schizophrenia 65.27 21.92 3 395398 21823 110172075
Purpura 65.15 21.92 6 395395 24382 110169516
Myocarditis 64.94 21.92 14 395387 30041 110163857
Chronic sinusitis 64.84 21.92 7 395394 25077 110168821
Acute generalised exanthematous pustulosis 64.71 21.92 3 395398 21661 110172237
Sputum discoloured 64.65 21.92 11 395390 27934 110165964
Immune thrombocytopenia 64.43 21.92 4 395397 22490 110171408
Unevaluable event 64.30 21.92 70 395331 59157 110134741
Myasthenia gravis 64.19 21.92 3 395398 21508 110172390
Drug resistance 64.16 21.92 64 395337 56310 110137588
Diabetes mellitus inadequate control 64.07 21.92 14 395387 29761 110164137
Dyspepsia 63.35 21.92 997 394404 189968 110003930
Cardiac murmur 63.34 21.92 7 395394 24621 110169277
Lung infiltration 63.34 21.92 7 395394 24621 110169277
Toxic skin eruption 63.29 21.92 11 395390 27504 110166394
Pustular psoriasis 63.12 21.92 146 395255 13459 110180439
Skin fissures 62.78 21.92 7 395394 24451 110169447
Arteriosclerosis coronary artery 62.47 21.92 8 395393 25110 110168788
Mental impairment 62.03 21.92 5 395396 22634 110171264
Sinus disorder 61.70 21.92 20 395381 32708 110161190
COVID-19 61.67 21.92 569 394832 244491 109949407
Blood pressure systolic abnormal 61.60 21.92 8 395393 24842 110169056
Influenza like illness 61.31 21.92 141 395260 88271 110105627
No adverse event 61.31 21.92 106 395295 73733 110120165
Oesophagitis 60.78 21.92 14 395387 28701 110165197
Delusion 60.47 21.92 7 395394 23748 110170150
Enterococcal infection 60.26 21.92 3 395398 20363 110173535
Sudden death 60.12 21.92 8 395393 24387 110169511
Hemiplegia 59.81 21.92 6 395395 22776 110171122
Injection site pruritus 59.72 21.92 57 395344 51201 110142697
Swollen tongue 59.48 21.92 77 395324 60285 110133613
Dermatitis atopic 59.21 21.92 10 395391 25531 110168367
Eye pain 59.20 21.92 55 395346 50044 110143854
Petechiae 59.03 21.92 7 395394 23310 110170588
Spondylitis 58.58 21.92 127 395274 11211 110182687
Acute coronary syndrome 58.36 21.92 7 395394 23105 110170793
Malnutrition 58.34 21.92 13 395388 27266 110166632
Therapeutic response unexpected 58.33 21.92 8 395393 23835 110170063
Basal cell carcinoma 57.97 21.92 317 395084 44953 110148945
Supraventricular tachycardia 57.88 21.92 9 395392 24413 110169485
Back pain 57.86 21.92 955 394446 370041 109823857
Mood altered 57.80 21.92 5 395396 21370 110172528
Dialysis 57.70 21.92 3 395398 19616 110174282
Blindness 57.50 21.92 29 395372 36330 110157568
Product dose omission in error 57.26 21.92 8 395393 23504 110170394
Sleep apnoea syndrome 57.19 21.92 37 395364 40410 110153488
Pulmonary alveolar haemorrhage 56.49 21.92 4 395397 20146 110173752
Lacrimation increased 56.46 21.92 20 395381 30930 110162968
Abortion spontaneous 56.27 21.92 26 395375 34256 110159642
Thirst 56.26 21.92 6 395395 21701 110172197
Klebsiella infection 56.01 21.92 4 395397 20005 110173893
Eye swelling 55.92 21.92 24 395377 33024 110160874
Hypoacusis 55.76 21.92 28 395373 35163 110158735
Sensory loss 55.43 21.92 6 395395 21451 110172447
Arthrodesis 55.34 21.92 58 395343 2660 110191238
Metastases to central nervous system 55.01 21.92 8 395393 22809 110171089
Skin haemorrhage 54.81 21.92 11 395390 24816 110169082
Anaphylactic shock 54.77 21.92 62 395339 51484 110142414
Blood pressure diastolic decreased 54.72 21.92 30 395371 35855 110158043
Retching 54.57 21.92 8 395393 22674 110171224
Lipase increased 54.46 21.92 3 395398 18669 110175229
Ulcer haemorrhage 54.27 21.92 191 395210 22380 110171518
Glomerular filtration rate decreased 54.05 21.92 18 395383 28938 110164960
Alanine aminotransferase increased 53.78 21.92 410 394991 183363 110010535
Rash papular 53.70 21.92 16 395385 27623 110166275
Aspiration 53.56 21.92 21 395380 30512 110163386
Metastases to lung 53.53 21.92 9 395392 23054 110170844
Atrioventricular block complete 53.49 21.92 5 395396 20077 110173821
Gastritis 53.43 21.92 68 395333 53631 110140267
Ankle arthroplasty 52.95 21.92 55 395346 2496 110191402
Malignant mediastinal neoplasm 52.93 21.92 42 395359 1336 110192562
Urine output decreased 52.80 21.92 5 395396 19871 110174027
Ventricular extrasystoles 52.19 21.92 9 395392 22632 110171266
Fungal infection 51.96 21.92 63 395338 50743 110143155
Hepatitis acute 51.82 21.92 4 395397 18762 110175136
Osteonecrosis 51.75 21.92 28 395373 33713 110160185
Swollen joint count 51.65 21.92 103 395298 8571 110185327
Duodenal ulcer 51.60 21.92 5 395396 19509 110174389
Deformity 51.57 21.92 113 395288 10047 110183851
Nail operation 51.31 21.92 45 395356 1649 110192249
Progressive multifocal leukoencephalopathy 51.19 21.92 13 395388 24943 110168955
Foot operation 51.16 21.92 93 395308 7220 110186678
Device related infection 50.83 21.92 40 395361 39479 110154419
Asthenia 50.75 21.92 1982 393419 687017 109506881
Aspartate aminotransferase increased 50.57 21.92 349 395052 159587 110034311
Bedridden 50.56 21.92 133 395268 13292 110180606
Cardiac failure acute 50.45 21.92 12 395389 24066 110169832
Blood triglycerides increased 49.98 21.92 12 395389 23914 110169984
Haemorrhoids 49.94 21.92 33 395368 35639 110158259
Tricuspid valve incompetence 49.82 21.92 12 395389 23861 110170037
Anticipatory anxiety 49.79 21.92 39 395362 1217 110192681
Incorrect dose administered 49.77 21.92 196 395205 103445 110090453
Pemphigoid 49.69 21.92 6 395395 19701 110174197
Escherichia infection 49.64 21.92 12 395389 23804 110170094
Polyarthritis 49.56 21.92 165 395236 18798 110175100
Rhinorrhoea 49.40 21.92 194 395207 102472 110091426
Blood calcium increased 49.38 21.92 4 395397 18036 110175862
Diabetes mellitus 48.97 21.92 186 395215 99195 110094703
Renal injury 48.94 21.92 5 395396 18708 110175190
Sinus congestion 48.62 21.92 24 395377 30435 110163463
Hypogammaglobulinaemia 48.49 21.92 7 395394 20069 110173829
Sneezing 48.39 21.92 27 395374 31957 110161941
Blood pressure diastolic abnormal 48.27 21.92 16 395385 25799 110168099
Cold sweat 48.14 21.92 10 395391 22021 110171877
Staphylococcal infection 48.14 21.92 112 395289 69832 110124066
Poor quality sleep 48.13 21.92 20 395381 28057 110165841
Food allergy 48.08 21.92 7 395394 19941 110173957
Product prescribing error 48.03 21.92 68 395333 51263 110142635
Aspergillus infection 47.68 21.92 16 395385 25600 110168298
Peripheral sensory neuropathy 47.67 21.92 3 395398 16677 110177221
Motor dysfunction 47.65 21.92 14 395387 24392 110169506
Infusion site pain 47.30 21.92 4 395397 17415 110176483
Procedural pain 47.02 21.92 35 395366 35530 110158368
Eating disorder 46.76 21.92 26 395375 30832 110163066
Vaginal discharge 46.28 21.92 5 395396 17903 110175995
Atelectasis 46.17 21.92 38 395363 36674 110157224
Peripheral coldness 45.88 21.92 6 395395 18534 110175364
Peritonitis 45.87 21.92 30 395371 32577 110161321
Colitis ischaemic 45.76 21.92 5 395396 17745 110176153
Hypertensive crisis 45.75 21.92 15 395386 24357 110169541
Polyuria 45.72 21.92 5 395396 17733 110176165
Skin burning sensation 45.49 21.92 11 395390 21814 110172084
Glycosylated haemoglobin increased 45.30 21.92 14 395387 23605 110170293
Paranoia 45.24 21.92 12 395389 22362 110171536
Cytomegalovirus infection reactivation 45.21 21.92 6 395395 18327 110175571
Toothache 45.16 21.92 14 395387 23561 110170337
Chest pain 45.15 21.92 1013 394388 375362 109818536
Cholecystitis 45.08 21.92 18 395383 25864 110168034
Restless legs syndrome 44.77 21.92 16 395385 24610 110169288
Hip fracture 44.68 21.92 36 395365 35115 110158783
Coronary artery occlusion 44.59 21.92 3 395398 15769 110178129
Fatigue 44.57 21.92 4981 390420 1210977 108982921
Tendonitis 44.35 21.92 198 395203 25885 110168013
Neurological symptom 44.04 21.92 3 395398 15605 110178293
Anal incontinence 43.99 21.92 12 395389 21952 110171946
Rhinitis allergic 43.87 21.92 6 395395 17916 110175982
Hyperthermia 43.79 21.92 11 395390 21261 110172637
Gangrene 43.70 21.92 4 395397 16337 110177561
Cystitis 43.65 21.92 108 395293 65928 110127970
Embolism 43.53 21.92 4 395397 16285 110177613
Blood pressure abnormal 43.53 21.92 13 395388 22411 110171487
Bunion operation 43.41 21.92 32 395369 910 110192988
Enteritis 43.32 21.92 8 395393 19148 110174750
Nocturia 43.26 21.92 5 395396 16985 110176913
Intestinal ischaemia 43.16 21.92 4 395397 16175 110177723
Atrioventricular block 42.89 21.92 5 395396 16872 110177026
Hydronephrosis 41.94 21.92 11 395390 20654 110173244
Gingival pain 41.69 21.92 4 395397 15732 110178166
Angina unstable 41.44 21.92 5 395396 16427 110177471
Rebound effect 41.33 21.92 3 395398 14803 110179095
Concomitant disease aggravated 41.21 21.92 5 395396 16359 110177539
Haematochezia 41.17 21.92 243 395158 115281 110078617
Intestinal perforation 40.92 21.92 12 395389 20932 110172966
Hepatitis 40.77 21.92 497 394904 89557 110104341
Renal cyst 40.22 21.92 8 395393 18164 110175734
Bacterial infection 40.15 21.92 64 395337 45972 110147926
Blood pressure diastolic increased 40.15 21.92 9 395392 18798 110175100
Complication associated with device 40.14 21.92 11 395390 20062 110173836
Epilepsy 39.86 21.92 540 394861 99669 110094229
Blood loss anaemia 39.76 21.92 8 395393 18017 110175881
Injection site rash 39.63 21.92 17 395384 23402 110170496
Erythema multiforme 39.58 21.92 13 395388 21084 110172814
Proteinuria 39.48 21.92 51 395350 39967 110153931
Product administration error 39.29 21.92 45 395356 37172 110156726
Iron deficiency anaemia 39.27 21.92 33 395368 31526 110162372
Hepatic enzyme 39.13 21.92 68 395333 5095 110188803
Pneumothorax 39.09 21.92 41 395360 35244 110158654
Respiratory symptom 39.07 21.92 4 395397 14941 110178957
Candida infection 38.88 21.92 70 395331 47939 110145959
Ageusia 38.85 21.92 11 395390 19634 110174264
Haemolysis 38.85 21.92 5 395396 15634 110178264
Facial paralysis 38.77 21.92 19 395382 24195 110169703
Acute pulmonary oedema 38.64 21.92 7 395394 16989 110176909
Central nervous system lesion 38.57 21.92 5 395396 15548 110178350
Burning sensation 38.50 21.92 123 395278 69089 110124809
Temperature intolerance 38.45 21.92 3 395398 13947 110179951
Extremity contracture 38.42 21.92 39 395362 1722 110192176
Device difficult to use 38.18 21.92 10 395391 18795 110175103
Hypertriglyceridaemia 38.17 21.92 6 395395 16148 110177750
Throat tightness 38.13 21.92 38 395363 33451 110160447
Poor venous access 38.12 21.92 20 395381 24502 110169396
Arterial occlusive disease 37.77 21.92 5 395396 15303 110178595
Staphylococcal bacteraemia 37.67 21.92 7 395394 16681 110177217
Drug specific antibody present 37.48 21.92 89 395312 8345 110185553
Apnoea 37.40 21.92 3 395398 13636 110180262
Injection site bruising 36.98 21.92 80 395321 51183 110142715
Herpes simplex 36.93 21.92 6 395395 15758 110178140
Joint ankylosis 36.72 21.92 45 395356 2452 110191446
Lymphoedema 36.54 21.92 5 395396 14924 110178974
Red cell distribution width increased 36.43 21.92 9 395392 17593 110176305
Subcutaneous drug absorption impaired 36.43 21.92 83 395318 7576 110186322
Paralysis 36.40 21.92 6 395395 15594 110178304
Eyelid ptosis 36.36 21.92 3 395398 13324 110180574
Macular degeneration 36.21 21.92 16 395385 21643 110172255
Left ventricular hypertrophy 36.08 21.92 3 395398 13241 110180657
Limb injury 36.07 21.92 49 395352 37587 110156311
Amnesia 35.96 21.92 553 394848 104855 110089043
Pulmonary tuberculosis 35.92 21.92 92 395309 9047 110184851
Spinal fracture 35.87 21.92 18 395383 22615 110171283
Spinal fusion surgery 35.81 21.92 92 395309 9064 110184834
Therapeutic response shortened 35.52 21.92 32 395369 29551 110164347
Aortic stenosis 35.46 21.92 3 395398 13056 110180842
Cardiac failure chronic 35.33 21.92 4 395397 13807 110180091
Mass 35.27 21.92 13 395388 19617 110174281
Injection site urticaria 35.25 21.92 9 395392 17206 110176692
Coronary artery stenosis 35.16 21.92 4 395397 13754 110180144
Hypokinesia 35.13 21.92 17 395384 21809 110172089
Enterocolitis 34.98 21.92 12 395389 18937 110174961
Blood glucose abnormal 34.98 21.92 3 395398 12913 110180985
Bundle branch block left 34.89 21.92 3 395398 12885 110181013
Exposure to toxic agent 34.79 21.92 3 395398 12855 110181043
Oral pain 34.64 21.92 50 395351 37394 110156504
Benign prostatic hyperplasia 34.62 21.92 11 395390 18223 110175675
Blood folate decreased 34.20 21.92 42 395359 2293 110191605
Vaginal haemorrhage 34.03 21.92 24 395377 25050 110168848
Sensory disturbance 34.02 21.92 10 395391 17419 110176479
Anaphylactic reaction 33.90 21.92 254 395147 114046 110079852
Autoimmune hepatitis 33.87 21.92 6 395395 14798 110179100
Grip strength 33.85 21.92 90 395311 9051 110184847
Amylase increased 33.66 21.92 3 395398 12516 110181382
Prostatic specific antigen increased 33.63 21.92 3 395398 12508 110181390
Head discomfort 33.44 21.92 13 395388 18987 110174911
Overlap syndrome 33.36 21.92 89 395312 8970 110184928
Pregnancy of partner 33.18 21.92 18 395383 294 110193604
Hypovolaemic shock 33.17 21.92 6 395395 14577 110179321
Exposure via skin contact 33.15 21.92 4 395397 13143 110180755
Encephalitis 32.98 21.92 13 395388 18826 110175072
Normal newborn 32.66 21.92 160 395241 21736 110172162
Eye irritation 32.62 21.92 43 395358 33409 110160489
Cholangitis 32.58 21.92 9 395392 16326 110177572
Hepatomegaly 32.51 21.92 18 395383 21396 110172502
Nerve injury 32.37 21.92 98 395303 10615 110183283
Exercise tolerance decreased 32.15 21.92 3 395398 12064 110181834
Gastritis erosive 31.93 21.92 3 395398 11997 110181901
Hiatus hernia 31.81 21.92 31 395370 27575 110166323
Infusion site erythema 31.79 21.92 3 395398 11956 110181942
Blood pressure systolic decreased 31.75 21.92 5 395396 13436 110180462
Ulcer 31.66 21.92 263 395138 42853 110151045
Muscle tightness 31.64 21.92 7 395394 14755 110179143
Large intestine perforation 31.63 21.92 10 395391 16619 110177279
Serum ferritin increased 31.42 21.92 3 395398 11844 110182054
Gastric haemorrhage 31.31 21.92 9 395392 15906 110177992
Decubitus ulcer 31.24 21.92 13 395388 18223 110175675
Rhinovirus infection 31.22 21.92 3 395398 11786 110182112
Body temperature increased 31.18 21.92 316 395085 54397 110139501
Hypoaesthesia oral 30.99 21.92 11 395390 16991 110176907
Device failure 30.90 21.92 75 395326 7132 110186766
Emphysema 30.88 21.92 16 395385 19740 110174158
Seasonal allergy 30.79 21.92 16 395385 19706 110174192
Choking 30.75 21.92 8 395393 15102 110178796
Infusion site reaction 30.65 21.92 135 395266 17547 110176351
Device breakage 30.60 21.92 6 395395 13763 110180135
Dementia 30.60 21.92 41 395360 31632 110162266
Rheumatoid lung 30.45 21.92 55 395346 4249 110189649
Administration site infection 30.40 21.92 9 395392 23 110193875
Iron deficiency 30.34 21.92 14 395387 18462 110175436
Psoriasis 29.87 21.92 683 394718 139310 110054588
Acne 29.81 21.92 46 395355 33474 110160424
Residual urine volume increased 29.73 21.92 12 395389 95 110193803
Product administration interrupted 29.58 21.92 3 395398 11289 110182609
Pathological fracture 29.52 21.92 4 395397 12028 110181870
Upper-airway cough syndrome 29.35 21.92 10 395391 15847 110178051
Cholecystitis acute 29.13 21.92 10 395391 15772 110178126
Erectile dysfunction 29.05 21.92 15 395386 18541 110175357
White blood cell count increased 28.82 21.92 215 395186 96627 110097271
Hypocholesterolaemia 28.80 21.92 68 395333 6353 110187545
Caesarean section 28.73 21.92 7 395394 13810 110180088
Orthopnoea 28.68 21.92 3 395398 11018 110182880
Metastases to lymph nodes 28.67 21.92 9 395392 15023 110178875
Middle insomnia 28.65 21.92 19 395382 20483 110173415
Anosmia 28.65 21.92 5 395396 12467 110181431
Haemorrhagic stroke 28.64 21.92 7 395394 13782 110180116
Personality change 28.62 21.92 3 395398 10999 110182899
Femur fracture 28.41 21.92 74 395327 44395 110149503
Aortic arteriosclerosis 28.41 21.92 3 395398 10935 110182963
Normochromic normocytic anaemia 28.38 21.92 6 395395 13051 110180847
Urosepsis 28.34 21.92 41 395360 30634 110163264
Hypermobility syndrome 28.03 21.92 20 395381 540 110193358
Osteopenia 27.91 21.92 23 395378 22186 110171712
Pneumonia fungal 27.84 21.92 9 395392 14745 110179153
Product prescribing issue 27.49 21.92 6 395395 12766 110181132
Generalised oedema 27.43 21.92 42 395359 30662 110163236
Anger 27.41 21.92 17 395384 18990 110174908
Dermatitis contact 27.25 21.92 8 395393 13945 110179953
Intracranial pressure increased 27.08 21.92 3 395398 10532 110183366
Terminal insomnia 27.01 21.92 34 395367 1904 110191994
Administration site haemorrhage 26.81 21.92 9 395392 39 110193859
Bladder cancer 26.78 21.92 20 395381 20272 110173626
Bacterial sepsis 26.72 21.92 3 395398 10423 110183475
Oral candidiasis 26.71 21.92 77 395324 44683 110149215
Epstein-Barr virus infection 26.69 21.92 17 395384 18721 110175177
Tuberculosis 26.60 21.92 130 395271 17644 110176254
Fine motor skill dysfunction 26.59 21.92 65 395336 6209 110187689
Retinal detachment 26.51 21.92 4 395397 11096 110182802
Paronychia 26.45 21.92 4 395397 11077 110182821
Disease susceptibility 26.41 21.92 16 395385 325 110193573
Oropharyngeal discomfort 26.39 21.92 3 395398 10324 110183574
Asphyxia 26.25 21.92 9 395392 14206 110179692
Abnormal loss of weight 26.16 21.92 3 395398 10254 110183644
Multiple sclerosis 26.13 21.92 32 395369 25666 110168232
Lower gastrointestinal haemorrhage 26.01 21.92 17 395384 18469 110175429
Odynophagia 25.91 21.92 9 395392 14092 110179806
Acute graft versus host disease 25.87 21.92 7 395394 12874 110181024
Skin irritation 25.83 21.92 13 395388 16306 110177592
Product preparation error 25.80 21.92 4 395397 10875 110183023
Papule 25.76 21.92 3 395398 10130 110183768
Breast pain 25.32 21.92 3 395398 9997 110183901
Spinal osteoarthritis 25.24 21.92 21 395380 20162 110173736
Dry eye 25.23 21.92 108 395293 55685 110138213
Major depression 24.97 21.92 4 395397 10617 110183281
Intervertebral disc degeneration 24.95 21.92 17 395384 18068 110175830
Rib fracture 24.94 21.92 52 395349 33718 110160180
Skin laceration 24.91 21.92 52 395349 33701 110160197
Vitamin D deficiency 24.86 21.92 18 395383 18534 110175364
Congestive cardiomyopathy 24.58 21.92 10 395391 14209 110179689
Skin lesion 24.55 21.92 98 395303 51533 110142365
Systemic inflammatory response syndrome 24.53 21.92 8 395393 13035 110180863
Post procedural complication 24.27 21.92 36 395365 26622 110167276
Hydrocephalus 24.19 21.92 4 395397 10371 110183527
Bone disorder 24.18 21.92 24 395377 21168 110172730
Dizziness postural 24.10 21.92 11 395390 14598 110179300
Deafness neurosensory 24.08 21.92 3 395398 9616 110184282
Tension headache 24.07 21.92 3 395398 9615 110184283
Axial spondyloarthritis 23.98 21.92 22 395379 856 110193042
Skin abrasion 23.91 21.92 14 395387 16137 110177761
Carotid artery occlusion 23.90 21.92 3 395398 9562 110184336
Photosensitivity reaction 23.84 21.92 34 395367 25555 110168343
Drug dose omission by device 23.84 21.92 11 395390 14505 110179393
Gallbladder disorder 23.78 21.92 24 395377 21005 110172893
Intentional dose omission 23.78 21.92 22 395379 20058 110173840
Tendon graft 23.69 21.92 6 395395 6 110193892
Pain of skin 23.65 21.92 22 395379 20007 110173891
Periorbital oedema 23.60 21.92 4 395397 10188 110183710
Eye disorder 23.54 21.92 42 395359 28864 110165034
Cerebral ischaemia 23.53 21.92 7 395394 12097 110181801
Mixed liver injury 23.45 21.92 7 395394 12072 110181826
Drug use disorder 23.43 21.92 127 395274 17947 110175951
Pain in extremity 23.38 21.92 2034 393367 485084 109708814
Ventricular arrhythmia 23.27 21.92 4 395397 10083 110183815
Eyelid oedema 22.92 21.92 13 395388 15249 110178649
Aphthous ulcer 22.92 21.92 25 395376 21111 110172787
Systemic candida 22.91 21.92 4 395397 9970 110183928
COVID-19 pneumonia 22.83 21.92 63 395338 37080 110156818
Dengue fever 22.78 21.92 26 395375 1313 110192585
Faeces soft 22.69 21.92 6 395395 11204 110182694
Vasculitis 22.68 21.92 60 395341 35813 110158085
Autoimmune haemolytic anaemia 22.67 21.92 5 395396 10562 110183336
Hepatocellular carcinoma 22.61 21.92 4 395397 9876 110184022
Blood creatinine decreased 22.51 21.92 3 395398 9134 110184764
Mouth ulceration 22.50 21.92 92 395309 48046 110145852
Bladder disorder 22.47 21.92 6 395395 11131 110182767
Blood disorder 22.39 21.92 4 395397 9806 110184092
Blood thyroid stimulating hormone increased 22.35 21.92 8 395393 12293 110181605
Pancreatitis 22.31 21.92 220 395181 93313 110100585
Clostridium difficile infection 22.31 21.92 103 395298 52026 110141872
Drug level below therapeutic 22.24 21.92 7 395394 11666 110182232
Haemoglobin abnormal 22.19 21.92 3 395398 9035 110184863
Increased appetite 22.15 21.92 13 395388 14964 110178934
Wrong product administered 21.93 21.92 6 395395 10954 110182944

FDA Adverse Event Reporting System (Pediatric)

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
Limb reduction defect 27.33 12.62 5 4 135 113809

Pharmacologic Action:

SourceCodeDescription
ATC L04AB06 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA MoA N0000175451 Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA D000079424 Tumor Necrosis Factor Inhibitors
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
FDA EPC N0000175610 Tumor Necrosis Factor Blocker
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:65023 anti-asthmatic agent
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AB Tumor necrosis factor alpha (TNF-alpha) inhibitors 4 drugs
adalimumabcertolizumab pegoletanerceptinfliximab

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

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Psoriasis with arthropathy indication 33339001
Ulcerative colitis indication 64766004 DOID:8577
Rheumatoid arthritis indication 69896004 DOID:7148
Juvenile idiopathic arthritis indication 410502007
Nonradiographic axial spondyloarthritis indication 713777005
Polyarticular juvenile idiopathic arthritis indication 16044800000000000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Tumor necrosis factor Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D04358 KEGG_DRUG
4028717 VUID
N0000178413 NUI
4028717 VANDF
CHEBI:749607 CHEBI
CHEMBL1201833 ChEMBL_ID
C529000 MESH_SUPPLEMENTAL_RECORD_UI
6776 IUPHAR_LIGAND_ID
DB06674 DRUGBANK_ID
819300 RXNORM
164144 MMSL
164146 MMSL
26409 MMSL
d07435 MMSL
013091 NDDF
442318002 SNOMEDCT_US
442435002 SNOMEDCT_US
C2353893 UMLSCUI
8497 INN_ID
91X1KLU43E UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-070 INJECTION, SOLUTION 50 mg SUBCUTANEOUS BLA 31 sections
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-070 INJECTION, SOLUTION 50 mg SUBCUTANEOUS BLA 31 sections
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-071 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-071 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
SIMPONI ARIA HUMAN PRESCRIPTION DRUG LABEL 1 57894-350 SOLUTION 50 mg INTRAVENOUS BLA 28 sections