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

Approvals:

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

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
Contraindicated product administered 3185.27 21.82 3351 189588 145607 50266578
Drug ineffective 3089.63 21.82 8383 184556 810950 49601235
Pemphigus 2768.33 21.82 2815 190124 117351 50294834
Glossodynia 2584.91 21.82 2665 190274 112904 50299281
Systemic lupus erythematosus 2481.76 21.82 2862 190077 137760 50274425
Drug intolerance 2306.27 21.82 3457 189482 215647 50196538
Joint swelling 2226.82 21.82 3615 189324 241671 50170514
Hand deformity 2066.93 21.82 2214 190725 97985 50314200
Therapeutic product effect decreased 2030.75 21.82 2544 190395 133506 50278679
Swelling 2008.77 21.82 3096 189843 197776 50214409
Alopecia 1846.44 21.82 3326 189613 241721 50170464
Arthropathy 1751.66 21.82 2556 190383 155350 50256835
Treatment failure 1735.38 21.82 2369 190570 135268 50276917
Abdominal discomfort 1726.68 21.82 3130 189809 228511 50183674
Wound 1602.52 21.82 1994 190945 103800 50308385
Synovitis 1576.18 21.82 2142 190797 121723 50290462
Anti-cyclic citrullinated peptide antibody positive 1456.57 21.82 1561 191378 69026 50343159
Lower respiratory tract infection 1455.39 21.82 1803 191136 93398 50318787
Pericarditis 1337.56 21.82 1573 191366 77116 50335069
Discomfort 1322.16 21.82 1837 191102 106543 50305642
Product use issue 1164.10 21.82 2061 190878 147414 50264771
Hypersensitivity 1157.65 21.82 2539 190400 212622 50199563
Pain 1096.13 21.82 4726 188213 574177 49838008
Folliculitis 1019.32 21.82 983 191956 38242 50373943
Muscle injury 1009.85 21.82 954 191985 36157 50376028
Irritable bowel syndrome 972.59 21.82 1087 191852 50354 50361831
Rheumatoid factor positive 939.92 21.82 1052 191887 48807 50363378
Death 912.65 21.82 92 192847 325287 50086898
Maternal exposure during pregnancy 867.92 21.82 1894 191045 157884 50254301
Rash 794.29 21.82 3531 189408 433940 49978245
Duodenal ulcer perforation 791.32 21.82 922 192017 44689 50367496
Ill-defined disorder 772.13 21.82 996 191943 53658 50358527
Helicobacter infection 766.03 21.82 946 191993 48756 50363429
Blister 764.57 21.82 1254 191685 84164 50328021
Infusion related reaction 759.18 21.82 1863 191076 167694 50244491
Hepatic enzyme increased 756.59 21.82 1638 191301 135742 50276443
Sleep disorder due to general medical condition, insomnia type 722.25 21.82 737 192202 30710 50381475
Anaemia 700.73 21.82 74 192865 252382 50159803
Infection 679.47 21.82 1809 191130 171145 50241040
Impaired healing 668.76 21.82 1057 191882 68729 50343456
Peripheral swelling 658.10 21.82 1999 190940 203937 50208248
Drug interaction 652.09 21.82 25 192914 199596 50212589
Toxicity to various agents 651.39 21.82 40 192899 212459 50199726
Hypotension 638.34 21.82 75 192864 235394 50176791
Rheumatoid arthritis 626.52 21.82 1944 190995 200606 50211579
Acute kidney injury 609.91 21.82 76 192863 227982 50184203
Sinusitis 590.70 21.82 1704 191235 168854 50243331
Arthralgia 543.00 21.82 3182 189757 435520 49976665
Psoriatic arthropathy 507.66 21.82 753 192186 46279 50365906
Gastrointestinal disorder 490.94 21.82 1101 191838 93355 50318830
Constipation 465.70 21.82 75 192864 185633 50226552
Knee arthroplasty 448.77 21.82 616 192323 35230 50376955
Neutropenia 441.05 21.82 32 192907 147933 50264252
Musculoskeletal stiffness 433.24 21.82 1272 191667 127209 50284976
Dehydration 411.78 21.82 49 192890 152400 50259785
Dizziness 403.45 21.82 436 192503 345933 50066252
Hip arthroplasty 402.31 21.82 537 192402 29892 50382293
Rheumatic fever 397.55 21.82 401 192538 16466 50395719
Fall 390.74 21.82 421 192518 334511 50077674
Stomatitis 380.22 21.82 1043 191896 100301 50311884
Anxiety 369.89 21.82 109 192830 177497 50234688
Thrombocytopenia 368.20 21.82 32 192907 127641 50284544
Febrile neutropenia 350.59 21.82 4 192935 97663 50314522
Therapeutic product effect incomplete 343.40 21.82 942 191997 90573 50321612
Hyponatraemia 332.17 21.82 7 192932 96132 50316053
Swollen joint count increased 318.73 21.82 336 192603 14537 50397648
Platelet count decreased 302.34 21.82 21 192918 100705 50311480
Cardiac arrest 302.19 21.82 3 192936 83648 50328537
Tremor 293.37 21.82 44 192895 114859 50297326
Fatigue 291.46 21.82 4034 188905 703567 49708618
Haemoglobin decreased 289.85 21.82 65 192874 127151 50285034
Nausea 289.23 21.82 1549 191390 703849 49708336
Device malfunction 267.61 21.82 309 192630 14812 50397373
Seizure 264.99 21.82 62 192877 117812 50294373
Loss of personal independence in daily activities 260.65 21.82 719 192220 69331 50342854
White blood cell count decreased 259.23 21.82 63 192876 116659 50295526
Oedema peripheral 258.54 21.82 140 192799 157821 50254364
Muscle spasticity 253.21 21.82 320 192619 16864 50395321
Overdose 245.99 21.82 42 192897 99685 50312500
Renal failure 245.89 21.82 53 192886 106580 50305605
Mobility decreased 244.30 21.82 765 192174 79183 50333002
Tachycardia 243.92 21.82 43 192896 99720 50312465
Nasopharyngitis 239.69 21.82 1403 191536 191524 50220661
Weight decreased 239.38 21.82 295 192644 220950 50191235
Disease progression 230.75 21.82 43 192896 95823 50316362
Respiratory failure 228.00 21.82 37 192902 91144 50321041
Type 2 diabetes mellitus 226.63 21.82 442 192497 33933 50378252
Ear pain 223.28 21.82 393 192546 27890 50384295
Muscle spasms 219.36 21.82 102 192837 125451 50286734
C-reactive protein abnormal 219.00 21.82 386 192553 27423 50384762
Bone erosion 218.96 21.82 246 192693 11441 50400744
Cardiac failure congestive 216.08 21.82 32 192907 84350 50327835
Gastrointestinal haemorrhage 215.13 21.82 17 192922 73304 50338881
Red blood cell sedimentation rate increased 213.42 21.82 394 192545 29022 50383163
Somnolence 210.82 21.82 169 192770 154816 50257369
Pancytopenia 208.09 21.82 35 192904 83995 50328190
Bradycardia 207.02 21.82 9 192930 64417 50347768
Oxygen saturation decreased 206.71 21.82 20 192919 73228 50338957
Condition aggravated 201.70 21.82 1870 191069 295188 50116997
Cardiac failure 201.40 21.82 26 192913 76014 50336171
Cough 201.15 21.82 384 192555 240880 50171305
Balance disorder 199.93 21.82 19 192920 70571 50341614
Sepsis 198.93 21.82 131 192808 132794 50279391
Coma 197.01 21.82 4 192935 56875 50355310
Feeling abnormal 194.21 21.82 119 192820 125373 50286812
Diarrhoea 192.45 21.82 1385 191554 587091 49825094
Hypokalaemia 190.52 21.82 50 192889 87942 50324243
Cardio-respiratory arrest 189.90 21.82 3 192936 53889 50358296
Chest discomfort 189.11 21.82 59 192880 92663 50319522
Drug tolerance decreased 185.77 21.82 201 192738 8959 50403226
Chest pain 184.86 21.82 242 192697 176640 50235545
Dysphagia 181.84 21.82 37 192902 77481 50334704
Suicide attempt 181.78 21.82 3 192936 51729 50360456
Pulmonary embolism 181.74 21.82 80 192859 101624 50310561
Body temperature increased 181.62 21.82 382 192557 30959 50381226
Hypoglycaemia 180.84 21.82 5 192934 53576 50358609
Vomiting 177.65 21.82 1031 191908 459727 49952458
Agitation 176.49 21.82 6 192933 53378 50358807
Injection site pain 176.41 21.82 102 192837 110922 50301263
Off label use 175.39 21.82 2657 190282 471769 49940416
Depressed level of consciousness 174.78 21.82 5 192934 51948 50360237
Myalgia 173.54 21.82 132 192807 124187 50287998
Abdominal pain 173.41 21.82 404 192535 235824 50176361
Hypoxia 171.69 21.82 5 192934 51118 50361067
Hyperhidrosis 170.09 21.82 64 192875 89362 50322823
Foot deformity 167.50 21.82 279 192660 18931 50393254
Grip strength decreased 166.46 21.82 218 192721 11903 50400282
Epistaxis 162.02 21.82 25 192914 63929 50348256
Night sweats 161.65 21.82 380 192559 33194 50378991
Blood pressure decreased 161.14 21.82 14 192925 55895 50356290
Neuropathy peripheral 157.88 21.82 86 192853 96671 50315514
Decreased appetite 157.79 21.82 331 192608 200592 50211593
Vision blurred 155.16 21.82 53 192886 78594 50333591
Renal impairment 154.54 21.82 48 192891 75613 50336572
Multiple organ dysfunction syndrome 152.46 21.82 10 192929 50327 50361858
Pleural effusion 152.08 21.82 60 192879 81394 50330791
International normalised ratio increased 149.58 21.82 3 192936 43149 50369036
Cerebrovascular accident 148.96 21.82 88 192851 94592 50317593
Gastrooesophageal reflux disease 148.21 21.82 53 192886 76375 50335810
Blood glucose increased 147.93 21.82 44 192895 71280 50340905
Blood pressure increased 147.59 21.82 174 192765 132958 50279227
Respiratory disorder 145.83 21.82 349 192590 30838 50381347
Dyspnoea exertional 141.92 21.82 15 192924 51218 50360967
Depression 140.66 21.82 260 192679 165163 50247022
Intentional product use issue 137.71 21.82 620 192319 76298 50335887
Dyspnoea 134.86 21.82 1387 191552 546221 49865964
Asthenia 133.65 21.82 694 192245 318348 50093837
Chronic kidney disease 133.15 21.82 4 192935 39767 50372418
Ankylosing spondylitis 131.12 21.82 149 192790 7016 50405169
Chronic obstructive pulmonary disease 130.64 21.82 23 192916 53412 50358773
Cognitive disorder 130.06 21.82 10 192929 44113 50368072
Rheumatoid nodule 128.92 21.82 198 192741 12537 50399648
Fluid retention 127.83 21.82 20 192919 50629 50361556
Adverse event 126.52 21.82 411 192528 43352 50368833
Sciatica 125.48 21.82 262 192677 21120 50391065
Mucosal inflammation 121.49 21.82 8 192931 40134 50372051
Neutrophil count decreased 121.23 21.82 16 192923 46010 50366175
Hyperglycaemia 120.66 21.82 4 192935 36401 50375784
Palpitations 119.96 21.82 110 192829 94396 50317789
Onychomycosis 119.01 21.82 120 192819 4922 50407263
Blood alkaline phosphatase increased 118.09 21.82 6 192933 37520 50374665
Dysarthria 117.64 21.82 6 192933 37397 50374788
Disorientation 117.25 21.82 4 192935 35480 50376705
Heart rate increased 117.06 21.82 75 192864 77175 50335010
Haematocrit decreased 115.37 21.82 4 192935 34972 50377213
Chills 115.24 21.82 119 192820 96568 50315617
Injection site erythema 114.59 21.82 72 192867 74864 50337321
Encephalopathy 114.30 21.82 3 192936 33708 50378477
Breast cancer stage III 112.80 21.82 96 192843 3160 50409025
Erythema 112.55 21.82 244 192695 146170 50266015
Drug delivery system malfunction 111.78 21.82 59 192880 849 50411336
Bedridden 111.23 21.82 157 192782 9210 50402975
Pulmonary oedema 109.41 21.82 26 192913 48912 50363273
Hepatic failure 108.98 21.82 3 192936 32280 50379905
Leukopenia 108.72 21.82 61 192878 67467 50344718
Blood bilirubin increased 108.07 21.82 3 192936 32035 50380150
Bone pain 107.76 21.82 24 192915 47205 50364980
Mental status changes 107.54 21.82 8 192931 36264 50375921
Blood creatinine increased 107.36 21.82 80 192859 76080 50336105
Hallucination 105.87 21.82 24 192915 46633 50365552
Wrong technique in product usage process 105.08 21.82 40 192899 55470 50356715
Hot flush 103.74 21.82 21 192918 44148 50368037
Ascites 103.28 21.82 9 192930 35852 50376333
Flushing 103 21.82 64 192875 66951 50345234
Unresponsive to stimuli 102.75 21.82 3 192936 30606 50381579
Blood cholesterol increased 102.53 21.82 450 192489 54765 50357420
Cardiac disorder 101.85 21.82 20 192919 42959 50369226
Joint stiffness 100.90 21.82 299 192640 30009 50382176
Respiratory arrest 100.52 21.82 3 192936 30006 50382179
Seronegative arthritis 99.82 21.82 74 192865 1987 50410198
Dysgeusia 99.04 21.82 15 192924 38901 50373284
Pruritus 97.47 21.82 1570 191369 281998 50130187
Blood parathyroid hormone decreased 96.21 21.82 127 192812 6987 50405198
Coronary artery disease 95.99 21.82 4 192935 29722 50382463
Pneumonia aspiration 94.36 21.82 6 192933 30998 50381187
Suicidal ideation 93.62 21.82 47 192892 55338 50356847
Granuloma skin 93.18 21.82 113 192826 5705 50406480
Atrial fibrillation 92.72 21.82 153 192786 101592 50310593
Gamma-glutamyltransferase increased 92.39 21.82 5 192934 29618 50382567
Disturbance in attention 92.11 21.82 7 192932 31179 50381006
Hypophagia 92.06 21.82 3 192936 27725 50384460
Back injury 92.01 21.82 124 192815 6961 50405224
Bone marrow failure 91.67 21.82 3 192936 27621 50384564
Inflammation 90.31 21.82 443 192496 56469 50355716
Pulmonary hypertension 89.50 21.82 11 192928 33406 50378779
Osteonecrosis of jaw 88.87 21.82 10 192929 32516 50379669
Syncope 88.29 21.82 161 192778 102841 50309344
Intentional product misuse 87.92 21.82 34 192905 46700 50365485
Enthesopathy 87.54 21.82 122 192817 7071 50405114
Septic shock 87.32 21.82 55 192884 57120 50355065
Generalised tonic-clonic seizure 86.81 21.82 3 192936 26307 50385878
Heart rate decreased 86.45 21.82 17 192922 36480 50375705
Red blood cell count decreased 86.20 21.82 13 192926 33822 50378363
Blood potassium decreased 85.86 21.82 18 192921 36927 50375258
Contusion 85.54 21.82 725 192214 111458 50300727
Melaena 85.48 21.82 4 192935 26860 50385325
Panniculitis 84.38 21.82 131 192808 8372 50403813
Thrombosis 83.50 21.82 55 192884 55778 50356407
Aphasia 82.47 21.82 7 192932 28487 50383698
Needle issue 82.07 21.82 119 192820 7156 50405029
General physical health deterioration 81.94 21.82 867 192072 141567 50270618
Urinary incontinence 81.45 21.82 7 192932 28201 50383984
Cholelithiasis 81.37 21.82 22 192917 37951 50374234
Lymphocyte count decreased 80.33 21.82 5 192934 26302 50385883
Dyskinesia 80.21 21.82 7 192932 27854 50384331
Urinary tract infection 79.89 21.82 513 192426 223507 50188678
Plasma cell myeloma 79.88 21.82 12 192927 31310 50380875
Irritability 79.56 21.82 8 192931 28418 50383767
Respiratory distress 79.34 21.82 11 192928 30478 50381707
Myocardial infarction 79.15 21.82 136 192803 88891 50323294
Product label confusion 79.10 21.82 39 192900 482 50411703
Angioedema 78.55 21.82 23 192916 37653 50374532
Adjustment disorder with depressed mood 77.72 21.82 73 192866 2741 50409444
Pain in jaw 77.35 21.82 25 192914 38403 50373782
Coeliac disease 76.86 21.82 127 192812 8558 50403627
Blood urea increased 76.74 21.82 3 192936 23582 50388603
Lethargy 76.25 21.82 47 192892 49385 50362800
Restlessness 76.22 21.82 5 192934 25168 50387017
Abdominal distension 75.81 21.82 100 192839 72803 50339382
Acute respiratory failure 75.81 21.82 10 192929 28772 50383413
Foetal exposure during pregnancy 75.79 21.82 8 192931 27351 50384834
Haemorrhage 75.48 21.82 56 192883 53385 50358800
Nail disorder 74.15 21.82 133 192806 9575 50402610
Dry skin 73.98 21.82 36 192903 43155 50369030
Premature delivery 73.77 21.82 4 192935 23659 50388526
Asthma 73.60 21.82 143 192796 89194 50322991
Orthostatic hypotension 73.58 21.82 12 192927 29469 50382716
Hypothyroidism 72.69 21.82 20 192919 34105 50378080
Nerve injury 72.42 21.82 121 192818 8229 50403956
Blood creatine phosphokinase increased 72.30 21.82 8 192931 26359 50385826
Pallor 72.08 21.82 4 192935 23195 50388990
Dislocation of vertebra 72 21.82 73 192866 3014 50409171
Nervousness 71.89 21.82 10 192929 27641 50384544
Oropharyngeal pain 71.80 21.82 116 192823 77685 50334500
Injection site swelling 71.27 21.82 35 192904 41738 50370447
Skin exfoliation 71.03 21.82 20 192919 33592 50378593
Malaise 69.33 21.82 883 192056 334649 50077536
Device dislocation 69.23 21.82 3 192936 21543 50390642
Flatulence 69.19 21.82 14 192925 29444 50382741
Memory impairment 68.94 21.82 123 192816 79237 50332948
Cholestasis 68.92 21.82 8 192931 25393 50386792
Agranulocytosis 68.77 21.82 3 192936 21418 50390767
Haematoma 68.61 21.82 16 192923 30494 50381691
Tenosynovitis 68.57 21.82 135 192804 10430 50401755
Red blood cell sedimentation rate 68.05 21.82 76 192863 3510 50408675
Haematuria 67.22 21.82 9 192930 25604 50386581
Head injury 66.60 21.82 7 192932 24013 50388172
Transient ischaemic attack 66.54 21.82 20 192919 32190 50379995
Shock 65.94 21.82 3 192936 20647 50391538
Adverse drug reaction 65.43 21.82 397 192542 54825 50357360
Abortion spontaneous 65.43 21.82 39 192900 41733 50370452
Deep vein thrombosis 65.14 21.82 112 192827 73192 50338993
Urinary retention 64.61 21.82 11 192928 26179 50386006
Altered state of consciousness 64.47 21.82 5 192934 21905 50390280
Arrhythmia 64.17 21.82 23 192916 33109 50379076
Product quality issue 64.03 21.82 19 192920 30839 50381346
White blood cell count increased 63.99 21.82 41 192898 42199 50369986
Peptic ulcer haemorrhage 63.88 21.82 43 192896 986 50411199
Paraesthesia 63.24 21.82 240 192699 120003 50292182
Acute myocardial infarction 62.64 21.82 17 192922 29256 50382929
Pericardial effusion 62.57 21.82 11 192928 25578 50386607
Live birth 62.54 21.82 170 192769 16238 50395947
Sinus tachycardia 62.48 21.82 5 192934 21349 50390836
Hepatocellular injury 61.63 21.82 12 192927 25935 50386250
Femur fracture 61.52 21.82 33 192906 37431 50374754
Rash erythematous 61.30 21.82 28 192911 34824 50377361
Abdominal pain lower 61.20 21.82 6 192933 21750 50390435
Sleep disorder 60.54 21.82 400 192539 56883 50355302
Onychomadesis 60.45 21.82 71 192868 3465 50408720
Haemoptysis 60.38 21.82 12 192927 25561 50386624
Arthrodesis 60.23 21.82 60 192879 2425 50409760
Mycotic allergy 60.09 21.82 38 192901 781 50411404
Lip swelling 59.69 21.82 11 192928 24725 50387460
Upper respiratory tract infection 59.18 21.82 100 192839 65798 50346387
Skin necrosis 58.97 21.82 129 192810 10738 50401447
Osteonecrosis 58.88 21.82 8 192931 22509 50389676
Renal disorder 58.81 21.82 16 192923 27489 50384696
Stevens-Johnson syndrome 58.64 21.82 7 192932 21745 50390440
Vertigo 58.19 21.82 67 192872 51765 50360420
Ejection fraction decreased 58.15 21.82 3 192936 18517 50393668
Rash maculo-papular 57.90 21.82 15 192924 26626 50385559
Ankle arthroplasty 57.49 21.82 42 192897 1102 50411083
Premature baby 57.48 21.82 3 192936 18334 50393851
Lymphadenopathy 57.25 21.82 28 192911 33471 50378714
Liver function test increased 57.23 21.82 221 192718 25385 50386800
Blood iron abnormal 57.22 21.82 67 192872 3259 50408926
Blood glucose decreased 57.02 21.82 3 192936 18208 50393977
Influenza like illness 56.54 21.82 82 192857 57377 50354808
Blood sodium decreased 56.53 21.82 7 192932 21140 50391045
Blood lactate dehydrogenase increased 56.08 21.82 5 192934 19557 50392628
Haematemesis 55.86 21.82 18 192921 27707 50384478
Blood pressure fluctuation 55.33 21.82 34 192905 35789 50376396
Panic attack 55.30 21.82 5 192934 19337 50392848
Circulatory collapse 55.01 21.82 6 192933 19994 50392191
Weight increased 54.40 21.82 1076 191863 200815 50211370
Hyperlipidaemia 54.39 21.82 3 192936 17487 50394698
Mitral valve incompetence 54.32 21.82 3 192936 17468 50394717
Red blood cell sedimentation rate abnormal 54.17 21.82 161 192778 16182 50396003
Hospitalisation 54.02 21.82 111 192828 67826 50344359
Oral discomfort 53.93 21.82 104 192835 7913 50404272
Presyncope 53.80 21.82 13 192926 24185 50388000
Bronchitis 53.41 21.82 210 192729 103949 50308236
Productive cough 53.04 21.82 74 192865 52620 50359565
Diabetic ketoacidosis 52.81 21.82 4 192935 17868 50394317
Hepatic function abnormal 51.91 21.82 30 192909 32651 50379534
Dry mouth 51.60 21.82 84 192855 56094 50356091
Fibromyalgia 51.17 21.82 320 192619 44658 50367527
Pollakiuria 50.76 21.82 14 192925 23837 50388348
Eye swelling 50.72 21.82 8 192931 20136 50392049
Visual acuity reduced 50.70 21.82 8 192931 20131 50392054
Liver injury 50.54 21.82 208 192731 24598 50387587
Eosinophilia 50.29 21.82 6 192933 18646 50393539
Joint dislocation 50.26 21.82 131 192808 12202 50399983
Hypoacusis 50.21 21.82 9 192930 20638 50391547
Injection site pruritus 50.12 21.82 48 192891 40363 50371822
Dysuria 49.98 21.82 23 192916 28481 50383704
Intestinal obstruction 49.94 21.82 19 192920 26364 50385821
Transaminases increased 49.49 21.82 22 192917 27802 50384383
Throat irritation 49.12 21.82 27 192912 30212 50381973
Fine motor skill dysfunction 49.05 21.82 69 192870 4034 50408151
Sleep apnoea syndrome 48.97 21.82 15 192924 23853 50388332
Emotional distress 48.92 21.82 24 192915 28639 50383546
Eye pain 48.28 21.82 24 192915 28425 50383760
Heart rate irregular 48.05 21.82 8 192931 19352 50392833
Diplopia 47.71 21.82 8 192931 19252 50392933
Disseminated intravascular coagulation 47.49 21.82 5 192934 17130 50395055
Cardiomyopathy 47.47 21.82 3 192936 15583 50396602
Muscle twitching 46.91 21.82 3 192936 15428 50396757
Pancreatitis 46.85 21.82 56 192883 42558 50369627
Eating disorder 46.83 21.82 3 192936 15406 50396779
Mental disorder 46.63 21.82 13 192926 21978 50390207
Burning sensation 46.56 21.82 63 192876 45383 50366802
Hypercholesterolaemia 46.36 21.82 123 192816 11580 50400605
Upper gastrointestinal haemorrhage 46.24 21.82 4 192935 16031 50396154
Pustular psoriasis 46.19 21.82 66 192873 3915 50408270
Angina pectoris 46.12 21.82 21 192918 26167 50386018
Myelodysplastic syndrome 45.83 21.82 3 192936 15129 50397056
Extremity contracture 45.71 21.82 38 192901 1210 50410975
Cerebral haemorrhage 45.64 21.82 23 192916 27029 50385156
Rash macular 45.61 21.82 9 192930 19268 50392917
Systemic lupus erythematosus rash 45.56 21.82 44 192895 1711 50410474
Ventricular tachycardia 45.48 21.82 4 192935 15817 50396368
Basal cell carcinoma 45.36 21.82 193 192746 23163 50389022
Rectal haemorrhage 45.31 21.82 48 192891 38510 50373675
Epilepsy 45.26 21.82 13 192926 21554 50390631
Face oedema 45.11 21.82 7 192932 17832 50394353
Depressed mood 45.08 21.82 38 192901 33985 50378200
Clostridium difficile colitis 44.78 21.82 7 192932 17735 50394450
Gastritis 44.75 21.82 36 192903 32947 50379238
Feeling hot 44.74 21.82 50 192889 39152 50373033
Exostosis 44.67 21.82 121 192818 11532 50400653
Bunion operation 44.54 21.82 36 192903 1101 50411084
Nervous system disorder 44.28 21.82 5 192934 16218 50395967
Skin discolouration 44.13 21.82 36 192903 32721 50379464
Acute respiratory distress syndrome 43.76 21.82 13 192926 21086 50391099
Pancreatitis acute 43.67 21.82 18 192921 23794 50388391
Confusional state 43.58 21.82 971 191968 184957 50227228
Colitis 43.04 21.82 50 192889 38479 50373706
Sinus disorder 42.87 21.82 9 192930 18449 50393736
Vaginal haemorrhage 42.75 21.82 20 192919 24531 50387654
Metastases to liver 42.41 21.82 12 192927 20092 50392093
Hemiparesis 42.23 21.82 12 192927 20036 50392149
Hypocalcaemia 42.04 21.82 25 192914 26791 50385394
Tongue disorder 41.85 21.82 102 192837 9114 50403071
Foot operation 41.46 21.82 75 192864 5435 50406750
Unevaluable event 41.27 21.82 70 192869 45996 50366189
Nasal congestion 41.08 21.82 83 192856 51037 50361148
Alanine aminotransferase increased 41.06 21.82 185 192754 88174 50324011
Ischaemic stroke 40.92 21.82 6 192933 15942 50396243
Haemorrhoids 40.89 21.82 11 192928 19042 50393143
Injection site bruising 40.76 21.82 48 192891 36720 50375465
Restless legs syndrome 40.74 21.82 6 192933 15891 50396294
Cyanosis 40.65 21.82 5 192934 15179 50397006
Feeling cold 40.57 21.82 12 192927 19519 50392666
Walking aid user 40.31 21.82 81 192858 6352 50405833
Drug hypersensitivity 40.29 21.82 1247 191692 249763 50162422
Atelectasis 40.26 21.82 10 192929 18260 50393925
Uveitis 40.12 21.82 101 192838 9209 50402976
Myelosuppression 40.01 21.82 3 192936 13514 50398671
Pulmonary fibrosis 39.30 21.82 191 192748 24246 50387939
Fungal infection 39.06 21.82 34 192905 29931 50382254
Diabetes mellitus inadequate control 38.68 21.82 3 192936 13142 50399043
Chromaturia 38.59 21.82 5 192934 14585 50397600
Hypermobility syndrome 38.51 21.82 28 192911 729 50411456
Bacteraemia 38.04 21.82 5 192934 14428 50397757
Transfusion 37.82 21.82 3 192936 12902 50399283
Drug tolerance 37.78 21.82 68 192871 4908 50407277
Tricuspid valve incompetence 37.33 21.82 3 192936 12767 50399418
Faeces discoloured 37.17 21.82 8 192931 16116 50396069
Nephrolithiasis 37.10 21.82 243 192696 34450 50377735
Immobile 37.02 21.82 68 192871 4986 50407199
Small intestinal obstruction 36.98 21.82 8 192931 16060 50396125
Therapeutic response decreased 36.89 21.82 307 192632 46924 50365261
Lung infiltration 36.88 21.82 4 192935 13389 50398796
Tinnitus 36.57 21.82 32 192907 28100 50384085
Complication associated with device 36.49 21.82 6 192933 14649 50397536
Therapy non-responder 36.38 21.82 325 192614 50697 50361488
Muscular weakness 36.20 21.82 213 192726 94800 50317385
Disease susceptibility 36.14 21.82 17 192922 188 50411997
Fear 36.13 21.82 6 192933 14543 50397642
Platelet count increased 36.10 21.82 6 192933 14534 50397651
Toothache 35.79 21.82 10 192929 16884 50395301
Injection site mass 35.70 21.82 8 192931 15672 50396513
Pneumonia 35.68 21.82 1135 191804 377266 50034919
Arthritis 35.46 21.82 495 192444 86226 50325959
Swelling face 35.34 21.82 94 192845 52501 50359684
Loss of consciousness 35.11 21.82 243 192696 104110 50308075
Bronchospasm 35.01 21.82 7 192932 14847 50397338
Mental impairment 34.74 21.82 3 192936 12041 50400144
Therapeutic response unexpected 34.51 21.82 9 192930 15906 50396279
Cystitis 34.42 21.82 74 192865 44490 50367695
Lower limb fracture 34.36 21.82 126 192813 14120 50398065
Lacrimation increased 34.29 21.82 11 192928 16981 50395204
Eye pruritus 33.87 21.82 4 192935 12530 50399655
Caesarean section 33.62 21.82 9 192930 15630 50396555
Hiatus hernia 33.43 21.82 14 192925 18330 50393855
Liver function test abnormal 33.12 21.82 75 192864 44264 50367921
Progressive multifocal leukoencephalopathy 32.65 21.82 3 192936 11454 50400731
Full blood count abnormal 32.39 21.82 25 192914 23363 50388822
Anger 32.21 21.82 3 192936 11330 50400855
Blood triglycerides increased 32.14 21.82 3 192936 11309 50400876
No adverse event 31.98 21.82 49 192890 33529 50378656
Blood pressure diastolic decreased 31.90 21.82 12 192927 16769 50395416
Laboratory test abnormal 31.90 21.82 25 192914 23183 50389002
Rash papular 31.75 21.82 5 192934 12599 50399586
Urticaria 31.40 21.82 680 192259 128881 50283304
Glomerular filtration rate decreased 30.80 21.82 4 192935 11648 50400537
Adverse reaction 30.78 21.82 87 192852 8499 50403686
Hip fracture 30.78 21.82 32 192907 25899 50386286
Drug ineffective for unapproved indication 30.43 21.82 22 192917 21259 50390926
Cerebral infarction 30.04 21.82 23 192916 21581 50390604
Rib fracture 30.02 21.82 18 192921 19203 50392982
Poor quality sleep 29.86 21.82 13 192926 16633 50395552
Thirst 29.79 21.82 3 192936 10647 50401538
Intestinal sepsis 29.73 21.82 16 192923 240 50411945
Diverticulum 29.67 21.82 3 192936 10611 50401574
Injury associated with device 29.51 21.82 47 192892 3070 50409115
Dry eye 29.46 21.82 48 192891 32047 50380138
Product storage error 29.38 21.82 108 192831 12116 50400069
X-ray abnormal 29.36 21.82 43 192896 2609 50409576
Eczema 29.29 21.82 26 192913 22676 50389509
Hypersomnia 29.03 21.82 11 192928 15303 50396882
Tubulointerstitial nephritis 28.71 21.82 11 192928 15200 50396985
Peripheral coldness 28.50 21.82 3 192936 10280 50401905
Muscle tightness 28.49 21.82 3 192936 10277 50401908
Eye irritation 28.28 21.82 15 192924 17125 50395060
Fear of injection 28.20 21.82 68 192871 6035 50406150
Spinal fracture 28.19 21.82 12 192927 15561 50396624
Gastric ulcer 27.98 21.82 24 192915 21281 50390904
Throat tightness 27.97 21.82 23 192916 20824 50391361
Hepatomegaly 27.83 21.82 4 192935 10789 50401396
Pyrexia 27.81 21.82 1176 191763 379027 50033158
Cytomegalovirus infection 27.80 21.82 17 192922 17945 50394240
Anti-neutrophil cytoplasmic antibody positive vasculitis 27.69 21.82 39 192900 2283 50409902
Limb injury 27.59 21.82 22 192917 20228 50391957
Aspartate aminotransferase increased 27.55 21.82 179 192760 77819 50334366
Oral pain 27.41 21.82 33 192906 25000 50387185
Respiratory tract congestion 27.32 21.82 117 192822 14082 50398103
Neutrophil count increased 27.24 21.82 10 192929 14185 50398000
Feeding disorder 27.21 21.82 4 192935 10609 50401576
Aphthous ulcer 27.16 21.82 4 192935 10593 50401592
Hypoalbuminaemia 27.01 21.82 3 192936 9857 50402328
Alanine aminotransferase abnormal 26.84 21.82 53 192886 4103 50408082
Post procedural complication 26.77 21.82 12 192927 15092 50397093
Speech disorder 26.66 21.82 60 192879 35488 50376697
Sputum discoloured 26.45 21.82 9 192930 13386 50398799
Metastases to lung 26.38 21.82 5 192934 11015 50401170
Skin laceration 26.27 21.82 20 192919 18822 50393363
Ageusia 26.19 21.82 6 192933 11577 50400608
Blood pressure abnormal 26.17 21.82 8 192931 12739 50399446
Device breakage 25.91 21.82 3 192936 9544 50402641
Anal incontinence 25.88 21.82 6 192933 11484 50400701
Administration site pain 25.85 21.82 21 192918 647 50411538
Malnutrition 25.81 21.82 9 192930 13180 50399005
Product dose omission issue 25.78 21.82 899 192040 182939 50229246
Candida infection 25.76 21.82 31 192908 23492 50388693
Cardiac murmur 25.58 21.82 5 192934 10779 50401406
Dialysis 25.53 21.82 3 192936 9435 50402750
Pseudomonas infection 25.51 21.82 3 192936 9427 50402758
Deafness 25.50 21.82 14 192925 15677 50396508
Hypoaesthesia oral 25.40 21.82 5 192934 10723 50401462
Staphylococcal infection 25.20 21.82 62 192877 35554 50376631
Sensory disturbance 25.06 21.82 7 192932 11822 50400363
Incorrect product administration duration 24.96 21.82 3 192936 9272 50402913
Intervertebral disc compression 24.94 21.82 24 192915 929 50411256
Multiple allergies 24.91 21.82 80 192859 8383 50403802
Purpura 24.81 21.82 4 192935 9907 50402278
Back pain 24.73 21.82 644 192295 219386 50192799
Dyspepsia 24.70 21.82 173 192766 73924 50338261
Macular degeneration 24.62 21.82 12 192927 14376 50397809
Myopathy 24.49 21.82 3 192936 9136 50403049
Retinitis 24.46 21.82 33 192906 1854 50410331
Amnesia 24.43 21.82 81 192858 42179 50370006
Maternal exposure timing unspecified 24.40 21.82 47 192892 3573 50408612
Device related infection 24.15 21.82 26 192913 20709 50391476
Urticarial vasculitis 24.11 21.82 19 192920 560 50411625
Injection site rash 24.09 21.82 16 192923 16161 50396024
Tooth abscess 24.00 21.82 105 192834 12755 50399430
Incorrect dose administered 23.93 21.82 99 192840 48315 50363870
Acute generalised exanthematous pustulosis 23.79 21.82 3 192936 8935 50403250
Acute myeloid leukaemia 23.71 21.82 14 192925 15060 50397125
Petechiae 23.70 21.82 9 192930 12503 50399682
Vitamin D deficiency 23.69 21.82 7 192932 11395 50400790
Multiple sclerosis 23.53 21.82 26 192913 20467 50391718
Oral candidiasis 23.53 21.82 18 192921 16897 50395288
Intervertebral disc space narrowing 23.41 21.82 23 192916 914 50411271
Intervertebral disc degeneration 23.38 21.82 11 192928 13450 50398735
Blood pressure systolic increased 23.33 21.82 64 192875 35385 50376800
Tendon graft 23.30 21.82 6 192933 6 50412179
Blindness 23.23 21.82 19 192920 17250 50394935
Cold sweat 23.12 21.82 6 192933 10638 50401547
Injection site warmth 23.08 21.82 12 192927 13854 50398331
Ocular hyperaemia 23.02 21.82 26 192913 20266 50391919
Tendonitis 22.99 21.82 125 192814 16580 50395605
Acute coronary syndrome 22.98 21.82 4 192935 9370 50402815
Supraventricular tachycardia 22.96 21.82 10 192929 12791 50399394
Paraesthesia oral 22.80 21.82 9 192930 12212 50399973
Ventricular extrasystoles 22.70 21.82 6 192933 10510 50401675
Facial paralysis 22.70 21.82 10 192929 12705 50399480
Product prescribing error 22.56 21.82 28 192911 20933 50391252
Wound infection 22.53 21.82 99 192840 12049 50400136
Polyneuropathy 22.52 21.82 9 192930 12122 50400063
Joint range of motion decreased 22.50 21.82 134 192805 18378 50393807
Hypertensive crisis 22.47 21.82 11 192928 13143 50399042
Lipase increased 22.41 21.82 3 192936 8538 50403647
Malignant mediastinal neoplasm 22.40 21.82 18 192921 546 50411639
Urine output decreased 22.39 21.82 6 192933 10415 50401770
Pelvic fracture 22.30 21.82 8 192931 11512 50400673
Heavy menstrual bleeding 22.30 21.82 16 192923 15521 50396664
Amenorrhoea 22.22 21.82 3 192936 8481 50403704
Premature labour 22.16 21.82 8 192931 11468 50400717
Sneezing 22.15 21.82 13 192926 14031 50398154
Product complaint 22.13 21.82 8 192931 11458 50400727
Lymphoedema 22.13 21.82 4 192935 9118 50403067
Osteoporosis 22.05 21.82 265 192674 44614 50367571
Musculoskeletal disorder 22.00 21.82 127 192812 17222 50394963
Pneumonitis 21.97 21.82 50 192889 29460 50382725
Hypoaesthesia 21.92 21.82 347 192592 126910 50285275

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 906.46 19.95 1236 21414 361934 29189943
Treatment failure 400.78 19.95 284 22366 36655 29515222
Rheumatoid arthritis 392.94 19.95 266 22384 31886 29519991
Synovitis 375.78 19.95 178 22472 10712 29541165
Therapeutic product effect decreased 275.18 19.95 207 22443 29244 29522633
Product use issue 256.04 19.95 252 22398 51192 29500685
Lower respiratory tract infection 246.95 19.95 186 22464 26316 29525561
Product dose omission issue 242.48 19.95 332 22318 96051 29455826
Enthesopathy 230.16 19.95 92 22558 3651 29548226
Device malfunction 207.65 19.95 110 22540 8397 29543480
Drug hypersensitivity 206.65 19.95 258 22392 68148 29483729
Psoriatic arthropathy 199.68 19.95 130 22520 14561 29537316
Tenosynovitis 196.21 19.95 82 22568 3651 29548226
Contraindicated product administered 192.21 19.95 138 22512 18128 29533749
Drug specific antibody present 178.73 19.95 69 22581 2492 29549385
Drug intolerance 176.54 19.95 201 22449 48178 29503699
C-reactive protein abnormal 149.63 19.95 81 22569 6455 29545422
Tongue disorder 145.34 19.95 71 22579 4565 29547312
Acute kidney injury 144.76 19.95 17 22633 265250 29286627
Off label use 142.28 19.95 528 22122 300272 29251605
Ankylosing spondylitis 140.11 19.95 67 22583 4109 29547768
Uveitis 128.66 19.95 71 22579 5876 29546001
Alanine aminotransferase abnormal 125.97 19.95 56 22594 2901 29548976
Pain 124.55 19.95 349 22301 171083 29380794
Toxicity to various agents 115.35 19.95 4 22646 173657 29378220
Drug use disorder 112.06 19.95 54 22596 3368 29548509
Death 111.53 19.95 62 22588 342022 29209855
Tendonitis 95.00 19.95 65 22585 7896 29543981
Pulmonary tuberculosis 94.66 19.95 52 22598 4263 29547614
Arthralgia 93.28 19.95 276 22374 139341 29412536
Drug interaction 93.15 19.95 19 22631 197366 29354511
Needle issue 90.69 19.95 52 22598 4631 29547246
Joint swelling 82.08 19.95 141 22509 49489 29502388
Product storage error 79.99 19.95 54 22596 6416 29545461
Inappropriate schedule of product administration 79.74 19.95 131 22519 44341 29507536
Oral herpes 76.39 19.95 46 22604 4486 29547391
Drug delivery system malfunction 76.25 19.95 21 22629 249 29551628
Therapeutic response decreased 75.71 19.95 94 22556 24617 29527260
Confusional state 72.65 19.95 7 22643 127870 29424007
Inflammation 72.12 19.95 88 22562 22640 29529237
Dyspnoea 71.91 19.95 87 22563 326645 29225232
Red blood cell sedimentation rate abnormal 71.36 19.95 35 22615 2268 29549609
Hypotension 71.11 19.95 30 22620 194324 29357553
Neutropenia 70.31 19.95 9 22641 131702 29420175
Musculoskeletal stiffness 69.39 19.95 112 22538 37346 29514531
Pneumonia 69.36 19.95 450 22200 319722 29232155
Accidental exposure to product 67.45 19.95 60 22590 10693 29541184
Headache 64.66 19.95 284 22366 173723 29378154
Gait inability 64.65 19.95 75 22575 18300 29533577
Anaemia 63.05 19.95 38 22612 200913 29350964
Device deployment issue 61.77 19.95 15 22635 103 29551774
Loss of personal independence in daily activities 59.79 19.95 85 22565 25355 29526522
Nasopharyngitis 59.30 19.95 137 22513 59528 29492349
Infection 58.22 19.95 159 22491 76592 29475285
Tuberculosis 57.15 19.95 46 22604 7150 29544727
Arthritis 55.01 19.95 81 22569 24938 29526939
Haematochezia 54.58 19.95 100 22550 36883 29514994
Arthropathy 53.60 19.95 74 22576 21480 29530397
Influenza 52.90 19.95 106 22544 41775 29510102
Therapeutic product effect incomplete 52.70 19.95 102 22548 39203 29512674
Colitis ulcerative 51.55 19.95 56 22594 12713 29539164
Thrombocytopenia 50.58 19.95 20 22630 134803 29417074
Dehydration 48.29 19.95 14 22636 114734 29437143
Pain in extremity 46.99 19.95 188 22462 110245 29441632
Psoriasis 44.87 19.95 85 22565 32142 29519735
Platelet count decreased 43.62 19.95 13 22637 104659 29447218
Decreased appetite 43.46 19.95 29 22621 145313 29406564
Cardiac arrest 42.97 19.95 7 22643 85584 29466293
Disease progression 42.72 19.95 6 22644 81910 29469967
Post procedural infection 41.78 19.95 31 22619 4274 29547603
Prostate cancer 41.48 19.95 72 22578 25455 29526422
Malignant melanoma 41.06 19.95 38 22612 7123 29544754
Blood creatinine increased 40.47 19.95 8 22642 85094 29466783
Neuropathy peripheral 40.01 19.95 4 22646 71023 29480854
Mobility decreased 39.67 19.95 71 22579 25709 29526168
Kidney infection 39.46 19.95 31 22619 4652 29547225
Joint ankylosis 39.12 19.95 14 22636 407 29551470
Cellulitis 38.83 19.95 99 22551 45741 29506136
Latent tuberculosis 38.61 19.95 18 22632 1041 29550836
Seizure 38.01 19.95 12 22638 93111 29458766
Renal failure 37.74 19.95 22 22628 118577 29433300
Bone erosion 36.43 19.95 24 22626 2736 29549141
Tachycardia 36.17 19.95 6 22644 72404 29479473
Herpes zoster 35.50 19.95 74 22576 29978 29521899
Constipation 35.17 19.95 22 22628 114138 29437739
Basal cell carcinoma 34.67 19.95 53 22597 16857 29535020
Underdose 34.51 19.95 44 22606 11825 29540052
Rheumatoid nodule 34.37 19.95 21 22629 2101 29549776
Pyrexia 33.47 19.95 111 22539 287511 29264366
Surgery 33.20 19.95 43 22607 11736 29540141
Oral candidiasis 33.16 19.95 41 22609 10681 29541196
Cardiac failure congestive 32.84 19.95 9 22641 76572 29475305
Injury associated with device 32.70 19.95 15 22635 836 29551041
Pharyngitis 32.42 19.95 33 22617 6950 29544927
Rheumatoid factor increased 31.96 19.95 13 22637 539 29551338
Red blood cell sedimentation rate 31.92 19.95 13 22637 541 29551336
Pancreatic carcinoma 31.77 19.95 33 22617 7117 29544760
Tooth abscess 31.48 19.95 28 22622 4986 29546891
Drug dependence 31.28 19.95 57 22593 20924 29530953
Hypersensitivity 30.94 19.95 100 22550 52803 29499074
Rheumatoid factor 30.84 19.95 8 22642 74 29551803
Hyponatraemia 30.83 19.95 7 22643 67626 29484251
Haemoglobin decreased 30.56 19.95 23 22627 108352 29443525
Rhabdomyolysis 30.45 19.95 5 22645 60803 29491074
Blood cholesterol abnormal 30.41 19.95 17 22633 1441 29550436
Panniculitis 30.38 19.95 16 22634 1205 29550672
Injection site reaction 30.22 19.95 40 22610 11148 29540729
White blood cell count decreased 30.21 19.95 13 22637 83349 29468528
Granuloma skin 29.95 19.95 13 22637 635 29551242
Colectomy 29.93 19.95 17 22633 1486 29550391
Therapy non-responder 29.61 19.95 70 22580 30841 29521036
Respiratory failure 29.52 19.95 19 22631 97112 29454765
Bradycardia 29.51 19.95 7 22643 65622 29486255
Osteoarthritis 29.32 19.95 51 22599 18052 29533825
Exostosis 28.62 19.95 23 22627 3566 29548311
Gastric disorder 28.50 19.95 38 22612 10666 29541211
Cardio-respiratory arrest 28.11 19.95 3 22647 50598 29501279
Tonsillitis 27.93 19.95 18 22632 1977 29549900
C-reactive protein increased 27.09 19.95 85 22565 44178 29507699
Blood parathyroid hormone decreased 26.96 19.95 13 22637 811 29551066
Hepatic steatosis 26.72 19.95 44 22606 14902 29536975
Vomiting 26.71 19.95 79 22571 212181 29339696
Oedema peripheral 26.69 19.95 24 22626 103533 29448344
Syphilis 26.57 19.95 10 22640 336 29551541
Overdose 26.54 19.95 14 22636 79805 29472072
Hypoglycaemia 26.51 19.95 3 22647 48343 29503534
Therapy cessation 26.43 19.95 43 22607 14419 29537458
Lymphoproliferative disorder 26.34 19.95 19 22631 2508 29549369
Lymphoma 26.33 19.95 35 22615 9793 29542084
Insomnia 26.12 19.95 18 22632 88743 29463134
Multiple organ dysfunction syndrome 25.98 19.95 8 22642 63108 29488769
Respiratory tract infection 25.23 19.95 44 22606 15607 29536270
Somnolence 25.15 19.95 21 22629 93934 29457943
Pelvic pain 24.86 19.95 17 22633 2062 29549815
Renal impairment 24.59 19.95 16 22634 81317 29470560
Arthritis bacterial 24.50 19.95 23 22627 4390 29547487
Chest pain 24.32 19.95 30 22620 111943 29439934
Pancytopenia 24.29 19.95 17 22633 83151 29468726
Agitation 24.01 19.95 5 22645 51299 29500578
Erythema 23.99 19.95 118 22532 75488 29476389
X-ray abnormal 23.44 19.95 10 22640 468 29551409
Disseminated tuberculosis 23.35 19.95 16 22634 1946 29549931
Neutrophil count decreased 23.16 19.95 3 22647 43564 29508313
Sacroiliitis 23.12 19.95 13 22637 1114 29550763
Musculoskeletal pain 22.94 19.95 61 22589 28892 29522985
Bladder transitional cell carcinoma stage II 22.71 19.95 6 22644 60 29551817
Skin cancer 22.45 19.95 30 22620 8438 29543439
Neck pain 22.11 19.95 50 22600 21397 29530480
Ear neoplasm 21.64 19.95 6 22644 73 29551804
Terminal insomnia 21.47 19.95 9 22641 403 29551474
Lower respiratory tract congestion 21.35 19.95 12 22638 1028 29550849
Lyme disease 21.30 19.95 11 22639 795 29551082
Atrial fibrillation 21.20 19.95 30 22620 105616 29446261
COVID-19 20.98 19.95 68 22582 35946 29515931
Epistaxis 20.49 19.95 7 22643 51697 29500180
Penile cancer 20.19 19.95 7 22643 185 29551692
Pregnancy of partner 20.13 19.95 8 22642 312 29551565
Lung carcinoma cell type unspecified stage 0 20.03 19.95 5 22645 39 29551838

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 2689.43 21.65 5856 140028 834391 63518457
Drug intolerance 2474.84 21.65 2559 143325 185433 64167415
Contraindicated product administered 2387.04 21.65 1964 143920 105865 64246983
Joint swelling 2136.16 21.65 2528 143356 212854 64139994
Synovitis 1927.45 21.65 1676 144208 97414 64255434
Therapeutic product effect decreased 1856.85 21.65 1754 144130 113597 64239251
Pemphigus 1839.20 21.65 1333 144551 59368 64293480
Systemic lupus erythematosus 1677.16 21.65 1395 144489 76217 64276631
Hand deformity 1632.74 21.65 1258 144626 61513 64291335
Glossodynia 1562.47 21.65 1241 144643 63455 64289393
Treatment failure 1561.01 21.65 1605 144279 115211 64237637
Anti-cyclic citrullinated peptide antibody positive 1479.60 21.65 1079 144805 48483 64304365
Arthropathy 1346.51 21.65 1509 144375 119458 64233390
Swelling 1336.84 21.65 1726 144158 158492 64194356
Pericarditis 1215.56 21.65 1058 144826 61458 64291390
Alopecia 1213.54 21.65 1675 144209 164015 64188833
Abdominal discomfort 1180.64 21.65 1738 144146 180584 64172264
Wound 1127.58 21.65 1109 144775 75368 64277480
Lower respiratory tract infection 1075.90 21.65 1194 144690 93420 64259428
Rheumatoid arthritis 1010.06 21.65 1529 144355 162765 64190083
Product use issue 972.58 21.65 1440 144444 150275 64202573
Discomfort 968.57 21.65 1049 144835 79829 64273019
Rheumatoid factor positive 942.44 21.65 716 145168 34222 64318626
Hypersensitivity 936.47 21.65 1629 144255 194823 64158025
Pain 872.81 21.65 2987 142897 550524 63802324
Duodenal ulcer perforation 790.18 21.65 643 145241 33982 64318866
Helicobacter infection 771.11 21.65 662 145222 37700 64315148
Death 760.95 21.65 98 145786 482607 63870241
Acute kidney injury 743.48 21.65 77 145807 449163 63903685
Irritable bowel syndrome 739.21 21.65 639 145245 36730 64316118
Hepatic enzyme increased 705.75 21.65 1143 144741 128800 64224048
Arthralgia 698.65 21.65 2390 143494 439870 63912978
Muscle injury 697.94 21.65 535 145349 25902 64326946
Folliculitis 693.57 21.65 562 145322 29515 64323333
Sleep disorder due to general medical condition, insomnia type 683.40 21.65 527 145357 25743 64327105
Drug interaction 675.73 21.65 35 145849 362048 63990800
Toxicity to various agents 666.42 21.65 39 145845 363474 63989374
Sinusitis 632.96 21.65 1162 144722 144766 64208082
Infection 596.50 21.65 1301 144583 183579 64169269
Maternal exposure during pregnancy 594.98 21.65 897 144987 94987 64257861
Peripheral swelling 591.75 21.65 1397 144487 207756 64145092
Psoriatic arthropathy 573.92 21.65 593 145291 42688 64310160
Infusion related reaction 568.07 21.65 1190 144694 163277 64189571
Anaemia 565.75 21.65 90 145794 378590 63974258
Hypotension 563.68 21.65 93 145791 380881 63971967
Musculoskeletal stiffness 542.87 21.65 988 144896 122218 64230630
Blister 511.56 21.65 764 145120 80203 64272645
Completed suicide 490.06 21.65 3 145881 224411 64128437
Rash 472.85 21.65 2169 143715 456380 63896468
Impaired healing 468.32 21.65 629 145255 59844 64293004
Neutropenia 434.91 21.65 27 145857 239597 64113251
Ill-defined disorder 427.90 21.65 513 145371 43539 64309309
Knee arthroplasty 407.63 21.65 397 145487 26602 64326246
Febrile neutropenia 397.84 21.65 5 145879 187652 64165196
Therapeutic product effect incomplete 396.41 21.65 782 145102 102700 64250148
Thrombocytopenia 381.14 21.65 34 145850 223767 64129081
Gastrointestinal disorder 359.48 21.65 691 145193 89018 64263830
Hip arthroplasty 343.19 21.65 325 145559 21026 64331822
Dehydration 333.75 21.65 47 145837 216716 64136132
C-reactive protein abnormal 326.91 21.65 365 145519 28682 64324166
Loss of personal independence in daily activities 325.17 21.65 586 145298 71868 64280980
Cardiac arrest 314.51 21.65 7 145877 154057 64198791
Constipation 297.42 21.65 76 145808 229261 64123587
Rheumatic fever 296.78 21.65 211 145673 9083 64343765
Hyponatraemia 287.28 21.65 11 145873 148328 64204520
Device malfunction 284.52 21.65 269 145615 17364 64335484
Platelet count decreased 284.07 21.65 26 145858 167685 64185163
Off label use 282.46 21.65 2414 143470 630392 63722456
Nasopharyngitis 272.52 21.65 1018 144866 195055 64157793
Red blood cell sedimentation rate increased 241.86 21.65 325 145559 30910 64321938
Tachycardia 235.96 21.65 30 145854 149549 64203299
Renal failure 235.92 21.65 60 145824 181628 64171220
Enthesopathy 234.65 21.65 186 145698 9452 64343396
Bone erosion 230.61 21.65 199 145685 11396 64341452
Haemoglobin decreased 228.49 21.65 78 145806 194985 64157863
Overdose 226.78 21.65 43 145841 159523 64193325
Respiratory failure 221.63 21.65 47 145837 161136 64191712
Mobility decreased 219.38 21.65 552 145332 85288 64267560
Swollen joint count increased 219.22 21.65 163 145721 7526 64345322
Seizure 216.90 21.65 55 145829 166837 64186011
Foot deformity 213.04 21.65 223 145661 16281 64336567
Disease progression 212.72 21.65 33 145851 141647 64211201
Bradycardia 212.31 21.65 14 145870 118205 64234643
Drug hypersensitivity 211.73 21.65 1080 144804 236735 64116113
Stomatitis 210.69 21.65 635 145249 108970 64243878
Rheumatoid nodule 207.93 21.65 195 145689 12456 64340392
Gastrointestinal haemorrhage 202.83 21.65 29 145855 132283 64220565
Tenosynovitis 201.45 21.65 186 145698 11647 64341201
Cardio-respiratory arrest 198.73 21.65 5 145879 98388 64254460
Cardiac failure congestive 196.98 21.65 30 145854 130550 64222298
Ankylosing spondylitis 196.38 21.65 157 145727 8077 64344771
Fall 195.73 21.65 406 145478 416420 63936428
Somnolence 193.50 21.65 110 145774 203535 64149313
Dizziness 192.85 21.65 430 145454 429733 63923115
Inflammation 190.49 21.65 442 145442 64858 64287990
White blood cell count decreased 190.30 21.65 60 145824 157777 64195071
Rhabdomyolysis 187.81 21.65 4 145880 91722 64261126
Drug delivery system malfunction 186.48 21.65 61 145823 414 64352434
Hypoglycaemia 183.74 21.65 4 145880 89888 64262960
Pancytopenia 182.82 21.65 49 145835 143260 64209588
Oedema peripheral 182.73 21.65 126 145758 210191 64142657
Renal impairment 180.30 21.65 42 145842 134975 64217873
Hypoxia 179.87 21.65 4 145880 88145 64264703
Multiple organ dysfunction syndrome 176.39 21.65 14 145870 101399 64251449
Coma 174.90 21.65 5 145879 87610 64265238
Ear pain 174.27 21.65 248 145636 24888 64327960
Adverse event 174.04 21.65 317 145567 39172 64313676
Muscle spasticity 173.19 21.65 201 145683 16468 64336380
Product dose omission issue 170.85 21.65 881 145003 193866 64158982
Anxiety 170.02 21.65 126 145758 202523 64150325
Dyspnoea 167.91 21.65 948 144936 717726 63635122
Sepsis 166.71 21.65 165 145719 230176 64122672
Cardiac failure 165.59 21.65 47 145837 132326 64220522
Agitation 160.04 21.65 10 145874 88357 64264491
Depressed level of consciousness 157.76 21.65 6 145878 81430 64271418
Breast cancer stage III 157.40 21.65 92 145792 2813 64350035
Condition aggravated 155.18 21.65 1401 144483 371025 63981823
Sciatica 151.02 21.65 207 145677 20057 64332791
Blood parathyroid hormone decreased 149.69 21.65 128 145756 7238 64345610
Epistaxis 149.24 21.65 22 145862 98109 64254739
Drug tolerance decreased 147.12 21.65 124 145760 6874 64345974
Oxygen saturation decreased 145.77 21.65 32 145852 107144 64245704
Grip strength decreased 145.25 21.65 155 145729 11569 64341279
Tongue disorder 144.90 21.65 157 145727 11923 64340925
Arthritis 142.96 21.65 466 145418 83348 64269500
Contusion 142.84 21.65 573 145311 113392 64239456
Fibromyalgia 142.71 21.65 275 145609 35456 64317392
Dysphagia 141.07 21.65 34 145850 106778 64246070
Granuloma skin 141.00 21.65 114 145770 5960 64346888
Panniculitis 138.56 21.65 133 145751 8746 64344102
Type 2 diabetes mellitus 138.54 21.65 264 145620 33756 64319092
Hypokalaemia 137.15 21.65 52 145832 121851 64230997
Chest pain 135.85 21.65 202 145682 235778 64117070
Suicide attempt 134.96 21.65 6 145878 71001 64281847
Hyperhidrosis 134.48 21.65 57 145827 124863 64227985
Pulmonary embolism 133.42 21.65 83 145801 146273 64206575
Tremor 127.11 21.65 90 145794 148140 64204708
Atrial fibrillation 126.71 21.65 120 145764 170969 64181879
Night sweats 125.50 21.65 262 145622 35784 64317064
Joint stiffness 125.11 21.65 237 145647 30167 64322681
Needle issue 124.55 21.65 128 145756 9144 64343704
Chest discomfort 121.77 21.65 55 145829 116051 64236797
Seronegative arthritis 120.64 21.65 76 145808 2667 64350181
Neutrophil count decreased 120.45 21.65 16 145868 77180 64275668
Hyperglycaemia 119.80 21.65 4 145880 60964 64291884
Alanine aminotransferase abnormal 118.66 21.65 109 145775 6779 64346069
Blood pressure decreased 114.68 21.65 27 145857 86172 64266676
Mental status changes 113.57 21.65 6 145878 61156 64291692
Vomiting 113.30 21.65 756 145128 550361 63802487
Onychomycosis 113.22 21.65 94 145790 5102 64347746
Red blood cell sedimentation rate abnormal 113.20 21.65 161 145723 16145 64336703
Chronic kidney disease 113.10 21.65 4 145880 57915 64294933
Balance disorder 110.26 21.65 27 145857 83899 64268949
Cerebrovascular accident 109.70 21.65 90 145794 137493 64215355
Blood creatinine increased 109.29 21.65 88 145796 135694 64217154
Leukopenia 109.27 21.65 46 145838 101196 64251652
Dysarthria 106.74 21.65 7 145877 59399 64293449
Ascites 106.58 21.65 9 145875 61992 64290856
Dyspnoea exertional 106.57 21.65 19 145865 73711 64279137
Red blood cell sedimentation rate 106.47 21.65 79 145805 3635 64349213
Fatigue 106.41 21.65 2324 143560 746406 63606442
Drug reaction with eosinophilia and systemic symptoms 104.99 21.65 4 145880 54213 64298635
Pleural effusion 104.41 21.65 80 145804 126479 64226369
Hepatic failure 104.23 21.65 5 145879 55389 64297459
Haematocrit decreased 102.63 21.65 5 145879 54650 64298198
Hallucination 102.55 21.65 20 145864 72768 64280080
Weight decreased 101.72 21.65 320 145564 285419 64067429
Coronary artery disease 100.59 21.65 10 145874 60423 64292425
Unresponsive to stimuli 100.11 21.65 3 145881 50390 64302458
Blood alkaline phosphatase increased 100.04 21.65 7 145877 56272 64296576
Encephalopathy 99.85 21.65 9 145875 58810 64294038
Vision blurred 99.15 21.65 40 145844 90276 64262572
Disorientation 99.07 21.65 7 145877 55821 64297027
Blood glucose increased 98.93 21.65 49 145835 98024 64254824
Tendonitis 98.61 21.65 170 145714 20112 64332736
Pneumonia aspiration 98.16 21.65 10 145874 59261 64293587
Body temperature increased 98.05 21.65 240 145644 36426 64316422
Adverse drug reaction 97.46 21.65 274 145610 45190 64307658
Blood creatine phosphokinase increased 96.66 21.65 10 145874 58548 64294300
Dislocation of vertebra 95.32 21.65 69 145815 3055 64349793
Cognitive disorder 94.68 21.65 8 145876 55079 64297769
Pulmonary oedema 94.61 21.65 30 145854 78644 64274204
Fluid retention 93.84 21.65 12 145872 59594 64293254
Septic shock 93.06 21.65 62 145822 105375 64247473
Uveitis 91.96 21.65 128 145756 12580 64340268
Intentional product misuse 91.63 21.65 25 145859 72270 64280578
Bedridden 90.44 21.65 113 145771 9996 64342852
Neuropathy peripheral 89.88 21.65 80 145804 117445 64235403
Nail disorder 87.92 21.65 103 145781 8521 64344327
Decreased appetite 86.66 21.65 335 145549 280954 64071894
Coeliac disease 86.57 21.65 95 145789 7317 64345531
Myalgia 86.25 21.65 141 145743 158476 64194372
Blood bilirubin increased 85.00 21.65 14 145870 57539 64295309
Skin necrosis 84.42 21.65 131 145753 14198 64338650
Respiratory distress 83.69 21.65 10 145874 52321 64300527
Blood urea increased 83.03 21.65 4 145880 44149 64308699
Blood iron abnormal 82.51 21.65 44 145840 1121 64351727
Bone marrow failure 82.31 21.65 7 145877 47945 64304903
Syncope 81.24 21.65 145 145739 157490 64195358
Respiratory disorder 80.73 21.65 221 145663 35890 64316958
Haematuria 80.32 21.65 19 145865 60452 64292396
Basal cell carcinoma 79.44 21.65 199 145685 30639 64322209
Pyrexia 78.77 21.65 846 145038 557798 63795050
Gamma-glutamyltransferase increased 78.25 21.65 9 145875 48501 64304347
Arthrodesis 77.95 21.65 52 145832 2015 64350833
Onychomadesis 77.46 21.65 59 145825 2825 64350023
Abdominal pain 76.47 21.65 405 145479 311970 64040878
Acute respiratory failure 76.36 21.65 11 145873 49923 64302925
Disturbance in attention 76.35 21.65 4 145880 41070 64311778
Multiple allergies 75.81 21.65 79 145805 5735 64347113
Melaena 74.82 21.65 15 145869 53533 64299315
Myocardial infarction 74.72 21.65 165 145719 165656 64187192
Acute myocardial infarction 74.71 21.65 32 145852 69686 64283162
Asthenia 74.06 21.65 616 145268 427428 63925420
Therapeutic response decreased 74.02 21.65 273 145611 51915 64300933
Shock 73.43 21.65 3 145881 38237 64314611
Cholestasis 73.20 21.65 8 145876 44864 64307984
Drug use disorder 73.16 21.65 79 145805 5975 64346873
Pruritus 72.90 21.65 1050 144834 311350 64041498
Lymphocyte count decreased 72.52 21.65 5 145879 40694 64312154
Orthostatic hypotension 72.16 21.65 10 145874 46728 64306120
Chills 71.86 21.65 125 145759 137139 64215709
Mycotic allergy 71.55 21.65 38 145846 960 64351888
Injury associated with device 71.47 21.65 56 145828 2797 64350051
Agranulocytosis 70.20 21.65 4 145880 38225 64314623
Aphasia 70.13 21.65 6 145878 40900 64311948
Mucosal inflammation 69.86 21.65 27 145857 62557 64290291
Muscle spasms 69.75 21.65 133 145751 140890 64211958
Pulmonary tuberculosis 69.70 21.65 84 145800 7160 64345688
Blood cholesterol increased 68.59 21.65 259 145625 49807 64303041
Kidney infection 68.43 21.65 135 145749 17703 64335145
Haemoptysis 67.99 21.65 14 145870 49034 64303814
Chronic obstructive pulmonary disease 67.96 21.65 38 145846 71010 64281838
Generalised tonic-clonic seizure 67.92 21.65 6 145878 39851 64312997
Intentional product use issue 67.88 21.65 408 145476 94956 64257892
Feeling abnormal 67.84 21.65 124 145760 133478 64219370
Wrong technique in product usage process 67.76 21.65 31 145853 64943 64287905
Restlessness 67.76 21.65 6 145878 39779 64313069
Systemic lupus erythematosus rash 66.50 21.65 41 145843 1384 64351464
Lower limb fracture 66.46 21.65 114 145770 13431 64339417
Cough 66.25 21.65 406 145478 301742 64051106
Heart rate decreased 66.20 21.65 21 145863 55046 64297802
Leukocytosis 66.20 21.65 5 145879 37735 64315113
Loss of consciousness 64.91 21.65 150 145734 148215 64204633
Pulmonary hypertension 64.82 21.65 10 145874 43129 64309719
Dyskinesia 64.31 21.65 7 145877 39381 64313467
Eosinophilia 64.16 21.65 6 145878 38070 64314778
Therapy non-responder 63.96 21.65 307 145577 65592 64287256
Altered state of consciousness 63.79 21.65 6 145878 37896 64314952
Upper gastrointestinal haemorrhage 63.72 21.65 4 145880 35216 64317632
Red blood cell count decreased 62.71 21.65 16 145868 48370 64304478
Hot flush 62.45 21.65 14 145870 46221 64306627
Fine motor skill dysfunction 61.54 21.65 64 145820 4635 64348213
Urinary retention 60.52 21.65 18 145866 49183 64303665
Rash maculo-papular 60.08 21.65 16 145868 47010 64305838
Nerve injury 59.52 21.65 80 145804 7605 64345243
Cardiac disorder 59.20 21.65 26 145858 55790 64297058
Blood lactate dehydrogenase increased 59.12 21.65 4 145880 33074 64319774
Administration site pain 59.06 21.65 25 145859 372 64352476
Palpitations 58.56 21.65 91 145793 104397 64248451
Plasma cell myeloma 58.26 21.65 16 145868 46059 64306789
White blood cell count increased 58.00 21.65 39 145845 65975 64286873
Drug tolerance 57.63 21.65 70 145814 6015 64346833
Extremity contracture 56.79 21.65 39 145845 1586 64351262
Drug specific antibody present 56.66 21.65 64 145820 5090 64347758
Dysgeusia 56.45 21.65 18 145866 47029 64305819
Stevens-Johnson syndrome 56.13 21.65 6 145878 34243 64318605
Blood pressure increased 56.03 21.65 201 145683 172351 64180497
Pallor 56.02 21.65 10 145874 38771 64314077
Osteonecrosis of jaw 55.97 21.65 11 145873 39814 64313034
Suicidal ideation 54.94 21.65 42 145842 66500 64286348
Pustular psoriasis 54.83 21.65 57 145827 4126 64348722
Lethargy 54.79 21.65 50 145834 72544 64280304
Exostosis 54.46 21.65 95 145789 11343 64341505
Sinus tachycardia 54.43 21.65 5 145879 32183 64320665
Foot operation 54.25 21.65 57 145827 4178 64348670
Cerebral haemorrhage 53.86 21.65 24 145860 51066 64301782
Hypercholesterolaemia 53.80 21.65 112 145772 15261 64337587
Respiratory tract congestion 53.36 21.65 115 145769 16050 64336798
Device deployment issue 53.17 21.65 47 145837 2779 64350069
Inappropriate schedule of product administration 52.94 21.65 374 145510 91912 64260936
Maternal exposure timing unspecified 52.89 21.65 46 145838 2661 64350187
Pancreatitis 52.65 21.65 35 145849 59572 64293276
Irritability 51.96 21.65 10 145874 36736 64316112
Wound infection 51.68 21.65 108 145776 14756 64338092
Sleep disorder 51.47 21.65 269 145615 59440 64293408
Hepatic function abnormal 51.33 21.65 42 145842 64271 64288577
Hypothyroidism 51.24 21.65 14 145870 40443 64312405
Fear of injection 51.16 21.65 65 145819 5847 64347001
Bunion operation 50.74 21.65 28 145856 765 64352083
Live birth 50.69 21.65 91 145793 11113 64341735
Ulcer 50.68 21.65 140 145744 22850 64329998
Thrombosis 50.58 21.65 51 145833 70591 64282257
Injection site pain 49.23 21.65 112 145772 111296 64241552
Product storage error 48.93 21.65 99 145785 13219 64339629
Heart rate increased 48.83 21.65 93 145791 98582 64254266
Blood sodium decreased 48.74 21.65 5 145879 29477 64323371
Flushing 48.51 21.65 64 145820 78584 64274264
Haematemesis 48.12 21.65 23 145861 46976 64305872
Hepatocellular injury 48.08 21.65 21 145863 45214 64307634
Nausea 47.68 21.65 1384 144500 784416 63568432
Disseminated intravascular coagulation 47.47 21.65 8 145876 32340 64320508
Diverticulitis 47.40 21.65 193 145691 38425 64314423
Pericardial effusion 47.13 21.65 15 145869 39239 64313609
Cholelithiasis 47.00 21.65 22 145862 45484 64307364
Blood potassium increased 46.85 21.65 3 145881 25977 64326871
Urinary incontinence 46.76 21.65 12 145872 36139 64316709
Lymphopenia 46.16 21.65 3 145881 25654 64327194
Gastrooesophageal reflux disease 46.02 21.65 73 145811 83070 64269778
Blood potassium decreased 45.80 21.65 17 145867 40382 64312466
Subdural haematoma 45.76 21.65 5 145879 28049 64324799
Nephrolithiasis 45.68 21.65 208 145676 43475 64309373
C-reactive protein increased 45.64 21.65 369 145515 94540 64258308
Angioedema 44.99 21.65 44 145840 61777 64291071
Diarrhoea 44.80 21.65 1269 144615 721435 63631413
Musculoskeletal pain 44.06 21.65 325 145559 80969 64271879
Haematoma 43.85 21.65 25 145859 46225 64306623
Psoriasis 43.73 21.65 295 145589 71408 64281440
Epilepsy 43.62 21.65 11 145873 33520 64319328
Haemorrhage 43.61 21.65 70 145814 79281 64273567
Adverse reaction 43.51 21.65 69 145815 7618 64345230
Drug-induced liver injury 43.41 21.65 27 145857 47616 64305232
Ischaemic stroke 43.01 21.65 7 145877 29028 64323820
Abdominal distension 42.83 21.65 96 145788 95898 64256950
Cardiomyopathy 42.71 21.65 4 145880 25352 64327496
Adjustment disorder with depressed mood 42.55 21.65 39 145845 2418 64350430
Transaminases increased 42.43 21.65 24 145860 44570 64308278
Lip swelling 42.42 21.65 10 145874 31897 64320951
Haemorrhage intracranial 42.36 21.65 3 145881 23881 64328967
Pancreatitis acute 42.32 21.65 22 145862 42833 64310015
Head injury 42.29 21.65 11 145873 32831 64320017
General physical health deterioration 41.03 21.65 670 145214 203755 64149093
Bacteraemia 40.98 21.65 6 145878 26905 64325943
Joint range of motion decreased 40.88 21.65 116 145768 19227 64333621
Urticaria 40.82 21.65 511 145373 146806 64206042
Transient ischaemic attack 40.31 21.65 25 145859 44157 64308691
Circulatory collapse 40.30 21.65 13 145871 33719 64319129
Myelodysplastic syndrome 40.08 21.65 7 145877 27572 64325276
Heart rate irregular 39.75 21.65 7 145877 27406 64325442
Tooth abscess 39.64 21.65 93 145791 13733 64339115
Joint dislocation 39.50 21.65 83 145801 11382 64341466
Presyncope 39.39 21.65 15 145869 35074 64317774
Arrhythmia 39.32 21.65 37 145847 52907 64299941
Pain in jaw 38.68 21.65 22 145862 40733 64312115
Acute respiratory distress syndrome 38.43 21.65 20 145864 38915 64313933
Neutropenic sepsis 38.34 21.65 4 145880 23268 64329580
Gastric disorder 38.31 21.65 149 145735 29048 64323800
Renal disorder 38.25 21.65 16 145868 35349 64317499
Abdominal pain lower 37.85 21.65 7 145877 26462 64326386
Disease susceptibility 37.68 21.65 16 145868 240 64352608
Hypocalcaemia 37.58 21.65 24 145860 41729 64311119
Rash erythematous 37.29 21.65 33 145851 48600 64304248
Clostridium difficile colitis 37.26 21.65 8 145876 27215 64325633
Myelosuppression 37.02 21.65 5 145879 23825 64329023
Tubulointerstitial nephritis 36.77 21.65 12 145872 30897 64321951
Tuberculosis 36.62 21.65 87 145797 12951 64339897
Lymphadenopathy 36.62 21.65 31 145853 46655 64306193
Device dislocation 36.60 21.65 3 145881 21175 64331673
Diplopia 36.36 21.65 8 145876 26757 64326091
Skin exfoliation 36.20 21.65 29 145855 44856 64307992
Lung infiltration 35.98 21.65 3 145881 20886 64331962
Retinitis 35.92 21.65 33 145851 2052 64350796
Deep vein thrombosis 35.83 21.65 120 145764 105062 64247786
Joint ankylosis 35.57 21.65 22 145862 747 64352101
Pregnancy 35.53 21.65 116 145768 20749 64332099
Nervous system disorder 35.48 21.65 5 145879 23073 64329775
Neutrophil count increased 35.28 21.65 7 145877 25167 64327681
Hyperlipidaemia 35.27 21.65 5 145879 22971 64329877
Hypermobility syndrome 35.04 21.65 19 145865 501 64352347
Depressed mood 35.00 21.65 25 145859 40987 64311861
Intervertebral disc compression 34.71 21.65 24 145860 987 64351861
Ankle arthroplasty 34.67 21.65 23 145861 883 64351965
Foot fracture 34.65 21.65 105 145779 18052 64334796
Chromaturia 34.52 21.65 5 145879 22606 64330242
Face oedema 34.46 21.65 7 145877 24754 64328094
Dry skin 34.32 21.65 39 145845 51122 64301726
Mitral valve incompetence 33.96 21.65 8 145876 25530 64327318
Oral discomfort 33.92 21.65 65 145819 8341 64344507
Osteoporosis 33.83 21.65 186 145698 41894 64310954
Gastric ulcer 33.81 21.65 13 145871 30221 64322627
Joint injury 33.34 21.65 121 145763 22826 64330022
Weight increased 33.22 21.65 672 145212 212676 64140172
Osteoarthritis 33.06 21.65 251 145633 63085 64289763
Atrial flutter 32.79 21.65 3 145881 19377 64333471
Rash macular 32.33 21.65 7 145877 23678 64329170
Cardiomegaly 32.33 21.65 7 145877 23677 64329171
Injection site reaction 32.14 21.65 198 145686 46466 64306382
Arthritis bacterial 32.11 21.65 61 145823 7778 64345070
Liver function test abnormal 32.08 21.65 53 145831 59348 64293500
Fear 31.89 21.65 4 145880 20167 64332681
Influenza 31.89 21.65 375 145509 106156 64246692
Injection site swelling 31.78 21.65 28 145856 41325 64311523
Visual acuity reduced 31.48 21.65 11 145873 27130 64325718
Flatulence 31.42 21.65 21 145863 35645 64317203
Herpes zoster 31.36 21.65 295 145589 78892 64273956
Cerebral infarction 31.29 21.65 28 145856 41016 64311832
Headache 30.60 21.65 1477 144407 527990 63824858
Gait inability 30.60 21.65 182 145702 42186 64310662
Faeces discoloured 30.59 21.65 10 145874 25719 64327129
Respiratory rate increased 30.59 21.65 3 145881 18328 64334520
Bronchospasm 30.44 21.65 6 145878 21676 64331172
Delirium 30.21 21.65 70 145814 69124 64283724
Metastases to bone 30.11 21.65 5 145879 20430 64332418
Back injury 30.11 21.65 59 145825 7698 64345150
Atelectasis 30.04 21.65 12 145872 27254 64325594
Musculoskeletal disorder 30 21.65 99 145785 17807 64335041
Hemiparesis 29.92 21.65 15 145869 29812 64323036
Product quality issue 29.87 21.65 15 145869 29784 64323064
Intestinal obstruction 29.83 21.65 23 145861 36263 64316585
Splenomegaly 29.81 21.65 3 145881 17958 64334890
Disability 29.73 21.65 77 145807 12095 64340753
Angina pectoris 29.56 21.65 35 145849 45046 64307802
Muscle twitching 29.48 21.65 4 145880 18994 64333854
Skin discolouration 29.42 21.65 22 145862 35233 64317615
Cyanosis 29.34 21.65 7 145877 22148 64330700
Malignant mediastinal neoplasm 29.16 21.65 17 145867 517 64352331
Haemophagocytic lymphohistiocytosis 29.08 21.65 3 145881 17606 64335242
Pneumonitis 29.04 21.65 43 145841 50322 64302526
Panic attack 29.00 21.65 6 145878 20947 64331901
Ileus 28.99 21.65 8 145876 22958 64329890
Limb discomfort 28.86 21.65 130 145754 27045 64325803
Breast cancer 28.42 21.65 136 145748 29012 64323836
Walking aid user 28.40 21.65 51 145833 6230 64346618
Intervertebral disc space narrowing 28.32 21.65 24 145860 1340 64351508
Anti-cyclic citrullinated peptide antibody 28.05 21.65 24 145860 1358 64351490
Nervousness 27.98 21.65 16 145868 29540 64323308
Tricuspid valve incompetence 27.81 21.65 3 145881 17000 64335848
Dialysis 27.64 21.65 3 145881 16917 64335931
Transfusion 27.42 21.65 4 145880 17990 64334858
Blood pressure fluctuation 27.35 21.65 47 145837 51824 64301024
Tonsillitis 27.27 21.65 48 145836 5772 64347076
Osteonecrosis 27.13 21.65 15 145869 28214 64324634
Bone pain 27.06 21.65 41 145843 47531 64305317
Glaucoma 27.04 21.65 90 145794 16258 64336590
Emotional distress 26.98 21.65 25 145859 36013 64316835
Hypoalbuminaemia 26.77 21.65 4 145880 17670 64335178
Aspergillus infection 26.51 21.65 3 145881 16376 64336472
Hunger 26.43 21.65 40 145844 4241 64348607
Tendon graft 26.42 21.65 6 145878 6 64352842
Liver function test increased 26.32 21.65 139 145745 30831 64322017
Glomerular filtration rate decreased 26.28 21.65 6 145878 19566 64333282
Depression 25.94 21.65 277 145607 183014 64169834
Acute coronary syndrome 25.77 21.65 6 145878 19304 64333544
Blood glucose decreased 25.76 21.65 10 145874 23113 64329735
Accidental exposure to product 25.70 21.65 123 145761 26241 64326607
Mood altered 25.68 21.65 3 145881 15976 64336872
Mental disorder 25.49 21.65 14 145870 26431 64326417
Sudden death 25.36 21.65 7 145877 20089 64332759
Hepatomegaly 25.16 21.65 4 145880 16878 64335970
Pseudomonas infection 25.00 21.65 5 145879 17878 64334970
Shock haemorrhagic 24.98 21.65 4 145880 16787 64336061
Latent tuberculosis 24.95 21.65 31 145853 2726 64350122
Borrelia infection 24.84 21.65 10 145874 130 64352718
Toe operation 24.74 21.65 15 145869 491 64352357
Hypersomnia 24.64 21.65 7 145877 19710 64333138
Renal injury 24.54 21.65 3 145881 15426 64337422
Colectomy 24.46 21.65 30 145854 2604 64350244
Laryngitis 24.14 21.65 67 145817 10964 64341884
Oropharyngeal pain 24.12 21.65 111 145773 88756 64264092
Pulmonary mass 24.10 21.65 113 145771 23903 64328945
Mental impairment 24.07 21.65 4 145880 16339 64336509
Intestinal sepsis 23.85 21.65 16 145868 626 64352222
Tooth infection 23.81 21.65 80 145804 14521 64338327
Spinal fusion surgery 23.81 21.65 35 145849 3616 64349232
Immune thrombocytopenia 23.79 21.65 3 145881 15063 64337785
Purpura 23.74 21.65 5 145879 17241 64335607
Malnutrition 23.51 21.65 7 145877 19118 64333730
Bronchopulmonary aspergillosis 23.44 21.65 7 145877 19078 64333770
Hypercalcaemia 23.36 21.65 136 145748 31280 64321568
Stress 23.21 21.65 224 145660 60310 64292538
Vertigo 23.19 21.65 63 145821 58948 64293900
Disseminated large cell lymphoma 23.00 21.65 8 145876 67 64352781
Post procedural infection 22.72 21.65 60 145824 9537 64343311
Pulmonary fibrosis 22.64 21.65 130 145754 29748 64323100
Rheumatoid lung 22.64 21.65 28 145856 2451 64350397
Petechiae 22.57 21.65 7 145877 18619 64334229
Arteriosclerosis coronary artery 22.44 21.65 4 145880 15525 64337323
Lipase increased 22.42 21.65 3 145881 14399 64338449
Ventricular extrasystoles 22.32 21.65 6 145878 17523 64335325
Angina unstable 22.31 21.65 4 145880 15463 64337385
Pollakiuria 22.30 21.65 23 145861 31507 64321341
Urine output decreased 22.26 21.65 5 145879 16487 64336361
Peritoneal tuberculosis 22.20 21.65 14 145870 492 64352356
Administration site haemorrhage 22.13 21.65 7 145877 42 64352806
Transplant rejection 22.08 21.65 6 145878 17395 64335453
Asthma 21.86 21.65 126 145758 95099 64257749
Neck deformity 21.85 21.65 23 145861 1689 64351159
Acute myeloid leukaemia 21.83 21.65 18 145866 27445 64325403
Acute generalised exanthematous pustulosis 21.72 21.65 3 145881 14055 64338793
Iodine allergy 21.66 21.65 14 145870 514 64352334

FDA Adverse Event Reporting System (Pediatric)

None

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 D000893 Anti-Inflammatory Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D000079424 Tumor Necrosis Factor Inhibitors
FDA EPC N0000175610 Tumor Necrosis Factor Blocker

Drug Use (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




🐶 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
CHEMBL1201833 ChEMBL_ID
C529000 MESH_SUPPLEMENTAL_RECORD_UI
6776 IUPHAR_LIGAND_ID
8497 INN_ID
DB06674 DRUGBANK_ID
91X1KLU43E UNII
819300 RXNORM
164144 MMSL
164146 MMSL
26409 MMSL
d07435 MMSL
442318002 SNOMEDCT_US
442435002 SNOMEDCT_US
C2353893 UMLSCUI
013091 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-070 INJECTION, SOLUTION 50 mg SUBCUTANEOUS BLA 30 sections
Simponi HUMAN PRESCRIPTION DRUG LABEL 1 57894-071 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 30 sections
SIMPONI ARIA HUMAN PRESCRIPTION DRUG LABEL 1 57894-350 SOLUTION 50 mg INTRAVENOUS BLA 29 sections