dupilumab šŸ¶ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
human origin 5224 1190264-60-8

Description:

MoleculeDescription

Synonyms:

  • dupilumab
  • REGN668
  • SAR231893
  • dupixent
Dupilumab is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4RĪ± subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Blocking IL-4RĪ± with dupilumab inhibits IL-4 and IL-13 cytokine-induced responses, including the release of proinflammatory cytokines, chemokines and IgE.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
21.40 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
July 3, 2017 EMA sanofi-aventis groupe
March 28, 2017 FDA REGENERON PHARMACEUTICALS
Jan. 19, 2018 PMDA Sanofi KK

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
Product use in unapproved indication 12924.62 25.45 6800 136932 172280 63173010
Injection site pain 7329.28 25.45 4204 139528 125596 63219694
Product dose omission issue 6162.86 25.45 4708 139024 229605 63115685
Pruritus 4941.00 25.45 5006 138726 356447 62988843
Eczema 4469.54 25.45 1929 141803 30362 63314928
Dry eye 3969.06 25.45 1906 141826 38855 63306435
Dry skin 3767.74 25.45 2051 141681 54836 63290454
Product use issue 3686.52 25.45 3418 140314 217102 63128188
Eye pruritus 3686.37 25.45 1439 142293 17232 63328058
Rash 3295.86 25.45 5088 138644 555783 62789507
Impaired quality of life 3153.38 25.45 1183 142549 12600 63332690
Injection site swelling 2822.14 25.45 1596 142136 45976 63299314
Eye irritation 2601.10 25.45 1177 142555 20794 63324496
Product dose omission in error 2518.50 25.45 859 142873 6753 63338537
Injection site erythema 2506.41 25.45 1820 141912 81354 63263936
Skin exfoliation 2392.50 25.45 1385 142347 41717 63303573
Ocular hyperaemia 2274.79 25.45 1119 142613 24025 63321265
COVID-19 2157.43 25.45 1892 141840 111211 63234079
Inappropriate schedule of product administration 2122.24 25.45 1808 141924 102157 63243133
Conjunctivitis 1954.31 25.45 950 142782 19846 63325444
Injection site rash 1848.34 25.45 886 142846 17923 63327367
Therapeutic response shortened 1593.12 25.45 695 143037 11193 63334097
Sleep disorder 1545.05 25.45 1360 142372 80206 63265084
Injection site pruritus 1520.73 25.45 1058 142674 44058 63301232
Incorrect dose administered 1467.95 25.45 1160 142572 58808 63286482
Therapeutic response decreased 1205.10 25.45 1046 142686 60479 63284811
Skin fissures 1172.16 25.45 554 143178 10834 63334456
Injection site reaction 1152.30 25.45 998 142734 57526 63287764
Injection site urticaria 1147.52 25.45 584 143148 13489 63331801
Oral herpes 919.44 25.45 629 143103 25445 63319845
Injection site bruising 915.68 25.45 759 142973 41151 63304139
Rash macular 882.06 25.45 588 143144 22776 63322514
Product preparation error 867.92 25.45 372 143360 5720 63339570
Accidental exposure to product 851.92 25.45 612 143120 26793 63318497
Erythema 846.43 25.45 1465 142267 174286 63171004
Skin burning sensation 824.26 25.45 453 143279 12281 63333009
Vision blurred 800.57 25.45 1013 142719 90911 63254379
Product prescribing issue 789.68 25.45 278 143454 2421 63342869
Illness 740.02 25.45 721 143011 48338 63296952
Drug effect less than expected 716.28 25.45 230 143502 1459 63343831
Condition aggravated 704.08 25.45 2252 141480 399965 62945325
Rash erythematous 624.74 25.45 616 143116 41894 63303396
Lacrimation increased 616.69 25.45 450 143282 20181 63325109
Diarrhoea 604.50 25.45 445 143287 714921 62630369
Drug intolerance 579.06 25.45 29 143703 308632 63036658
Skin swelling 575.77 25.45 236 143496 3223 63342067
Eye discharge 554.29 25.45 272 143460 5791 63339499
Eye pain 547.22 25.45 517 143215 33337 63311953
Acute kidney injury 546.66 25.45 10 143722 263405 63081885
Death 546.63 25.45 95 143637 374286 62971004
Skin haemorrhage 545.09 25.45 319 143413 9775 63335515
Toxicity to various agents 532.23 25.45 5 143727 247245 63098045
Injection site dryness 530.71 25.45 134 143598 284 63345006
Eye swelling 523.95 25.45 434 143298 23484 63321806
Nausea 511.02 25.45 717 143015 853754 62491536
Product storage error 508.74 25.45 353 143379 14603 63330687
Vomiting 497.41 25.45 329 143403 559288 62786002
Intentional dose omission 497.17 25.45 278 143454 7797 63337493
Infusion related reaction 495.04 25.45 13 143719 245508 63099782
Dermatitis atopic 479.94 25.45 290 143442 9434 63335856
Contraindicated product administered 475.26 25.45 3 143729 217645 63127645
Anaemia 463.72 25.45 59 143673 293371 63051919
Drug ineffective 460.93 25.45 3971 139761 1040794 62304496
Injection site irritation 460.08 25.45 225 143507 4753 63340537
SARS-CoV-2 test positive 449.31 25.45 260 143472 7796 63337494
Eye disorder 422.27 25.45 375 143357 22310 63322980
Eyelids pruritus 417.51 25.45 139 143593 1003 63344287
Hypotension 416.06 25.45 61 143671 272543 63072747
Injection site mass 413.77 25.45 341 143391 18315 63326975
Synovitis 405.93 25.45 3 143729 186915 63158375
Eyelid margin crusting 397.98 25.45 132 143600 940 63344350
Device use issue 385.83 25.45 164 143568 2466 63342824
Rheumatoid arthritis 379.98 25.45 60 143672 253759 63091531
Hepatic enzyme increased 372.98 25.45 21 143711 202307 63142983
Arthralgia 372.66 25.45 2381 141351 567329 62777961
Skin weeping 371.08 25.45 115 143617 638 63344652
Drug interaction 369.44 25.45 43 143689 229088 63116202
Periorbital swelling 366.23 25.45 163 143569 2755 63342535
Injection site exfoliation 361.99 25.45 97 143635 284 63345006
Swelling of eyelid 357.12 25.45 164 143568 2992 63342298
Asthenia 350.60 25.45 218 143514 383386 62961904
Neutropenia 349.92 25.45 10 143722 174995 63170295
Rebound eczema 348.50 25.45 69 143663 3 63345287
Confusional state 344.63 25.45 60 143672 236320 63108970
Lack of injection site rotation 340.19 25.45 96 143636 360 63344930
Rebound atopic dermatitis 338.81 25.45 74 143658 50 63345240
Discomfort 336.20 25.45 985 142747 166389 63178901
Erythema of eyelid 333.54 25.45 142 143590 2144 63343146
Treatment failure 331.95 25.45 33 143699 199010 63146280
Glossodynia 328.35 25.45 19 143713 178857 63166433
Extra dose administered 325.34 25.45 194 143538 6156 63339134
Blepharitis 322.19 25.45 146 143586 2579 63342711
Skin irritation 322.12 25.45 226 143506 9515 63335775
Systemic lupus erythematosus 320.41 25.45 46 143686 208872 63136418
Thrombocytopenia 316.47 25.45 5 143727 151152 63194138
Completed suicide 313.06 25.45 3 143729 145670 63199620
Arthropathy 312.37 25.45 74 143658 234718 63110572
General physical health deterioration 307.33 25.45 45 143687 201357 63143933
Abdominal pain 301.12 25.45 144 143588 293312 63051978
Eyelid skin dryness 293.82 25.45 70 143662 102 63345188
Haemoglobin decreased 291.98 25.45 8 143724 145477 63199813
Scratch 281.41 25.45 179 143553 6386 63338904
Visual impairment 274.57 25.45 597 143135 83849 63261441
Dermatitis 273.99 25.45 259 143473 16699 63328591
Pneumonia 263.27 25.45 392 143340 456375 62888915
Pericarditis 257.68 25.45 9 143723 131570 63213720
Fatigue 254.28 25.45 1093 142639 886935 62458355
Decreased appetite 250.22 25.45 128 143604 250924 63094366
Fall 248.85 25.45 314 143418 392020 62953270
Oedema peripheral 245.64 25.45 63 143669 189448 63155842
Joint swelling 242.21 25.45 231 143501 327435 63017855
Wrong technique in device usage process 241.08 25.45 131 143601 3467 63341823
Urticaria 237.55 25.45 870 142862 164932 63180358
White blood cell count decreased 237.35 25.45 21 143711 139083 63206207
Lower respiratory tract infection 236.93 25.45 16 143716 132291 63212999
Wound 236.64 25.45 42 143690 163221 63182069
Hypertension 233.24 25.45 175 143557 279128 63066162
Hyponatraemia 232.95 25.45 4 143728 111896 63233394
Constipation 232.77 25.45 109 143623 224834 63120456
Eyelid rash 229.63 25.45 57 143675 109 63345181
Injection site discolouration 225.03 25.45 167 143565 7681 63337609
Surgery 220.88 25.45 335 143397 35577 63309713
Abdominal discomfort 218.15 25.45 243 143489 320642 63024648
Sepsis 216.33 25.45 42 143690 153081 63192209
Eye inflammation 216.25 25.45 143 143589 5456 63339834
Alanine aminotransferase increased 214.82 25.45 4 143728 103766 63241524
Platelet count decreased 211.02 25.45 13 143719 116109 63229181
Overdose 208.77 25.45 13 143719 115065 63230225
Hospitalisation 204.57 25.45 535 143197 84546 63260744
Fear of injection 199.95 25.45 150 143582 7014 63338276
Hordeolum 199.00 25.45 112 143620 3180 63342110
Dehydration 193.69 25.45 75 143657 173279 63172011
Pulmonary embolism 187.68 25.45 22 143710 116662 63228628
Renal failure 187.22 25.45 23 143709 117629 63227661
Intentional product use issue 185.09 25.45 33 143699 127859 63217431
Aspartate aminotransferase increased 184.78 25.45 4 143728 90273 63255017
Rash pruritic 183.30 25.45 413 143319 59386 63285904
Helicobacter infection 182.87 25.45 6 143726 92779 63252511
Weight decreased 180.10 25.45 217 143515 276581 63068709
Impaired healing 178.99 25.45 14 143718 102528 63242762
Disease progression 176.95 25.45 32 143700 122726 63222564
Injection site discomfort 175.79 25.45 117 143615 4513 63340777
Blood creatinine increased 175.58 25.45 5 143727 87839 63257451
Eyelid irritation 174.52 25.45 60 143672 483 63344807
Injection site vesicles 173.79 25.45 99 143633 2878 63342412
Off label use of device 167.01 25.45 51 143681 267 63345023
Pleural effusion 164.75 25.45 12 143720 93198 63252092
Blood pressure increased 162.31 25.45 82 143650 161980 63183310
Pyrexia 162.02 25.45 536 143196 469942 62875348
Device defective 161.55 25.45 82 143650 1880 63343410
Cardiac arrest 160.51 25.45 13 143719 92532 63252758
Leukopenia 159.88 25.45 3 143729 77287 63268003
Pain of skin 158.69 25.45 162 143570 11472 63333818
Ocular discomfort 158.38 25.45 106 143626 4127 63341163
Respiratory failure 157.06 25.45 22 143710 101836 63243454
C-reactive protein increased 157.02 25.45 16 143716 94691 63250599
Needle issue 155.38 25.45 152 143580 10224 63335066
Intentional overdose 152.89 25.45 3 143729 74149 63271141
Periorbital irritation 152.79 25.45 30 143702 0 63345290
Tachycardia 151.66 25.45 40 143692 118116 63227174
Gastrointestinal haemorrhage 150.81 25.45 8 143724 81168 63264122
Drug abuse 149.26 25.45 3 143729 72515 63272775
Somnolence 148.99 25.45 112 143620 178573 63166717
Bradycardia 146.97 25.45 4 143728 73223 63272067
Stomatitis 145.32 25.45 66 143666 138659 63206631
Burning sensation 144.14 25.45 355 143377 54052 63291238
Eczema eyelids 143.85 25.45 39 143693 121 63345169
Renal impairment 143.73 25.45 16 143716 88339 63256951
Injection site warmth 142.52 25.45 174 143558 15021 63330269
Skin discolouration 142.25 25.45 284 143448 37544 63307746
Seizure 142.25 25.45 61 143671 132573 63212717
Injection site haemorrhage 141.34 25.45 221 143511 24093 63321197
Mobility decreased 141.07 25.45 49 143683 121110 63224180
Eyelid exfoliation 140.61 25.45 39 143693 135 63345155
Sensitive skin 139.01 25.45 72 143660 1724 63343566
Unevaluable event 136.88 25.45 336 143396 51050 63294240
Musculoskeletal stiffness 135.26 25.45 131 143601 184487 63160803
Atrial fibrillation 134.38 25.45 48 143684 116588 63228702
Septic shock 132.40 25.45 4 143728 66625 63278665
Musculoskeletal pain 130.95 25.45 25 143707 92252 63253038
Eye infection 130.35 25.45 149 143583 11996 63333294
Unintentional use for unapproved indication 130.05 25.45 38 143694 166 63345124
Muscle injury 129.56 25.45 4 143728 65341 63279949
Psoriatic arthropathy 129.44 25.45 25 143707 91495 63253795
Deep vein thrombosis 129.42 25.45 18 143714 83782 63261508
Irritable bowel syndrome 128.95 25.45 17 143715 82395 63262895
Injection site eczema 127.47 25.45 31 143701 52 63345238
Cardiac failure 126.82 25.45 24 143708 89118 63256172
Depressed level of consciousness 126.06 25.45 3 143729 62075 63283215
Urinary tract infection 125.91 25.45 256 143476 264428 63080862
Blood cholesterol increased 124.21 25.45 30 143702 94002 63251288
Oedema 121.63 25.45 35 143697 97587 63247703
Coma 120.64 25.45 6 143726 64358 63280932
Asthma 119.19 25.45 588 143144 126973 63218317
Cardiac failure congestive 119.17 25.45 31 143701 92402 63252888
Folliculitis 118.87 25.45 11 143721 70306 63274984
Skin discomfort 118.27 25.45 47 143685 589 63344701
Rash papular 116.29 25.45 160 143572 15542 63329748
Osteoarthritis 115.48 25.45 36 143696 95307 63249983
Multiple organ dysfunction syndrome 114.26 25.45 3 143729 56749 63288541
Neutrophil count decreased 113.50 25.45 3 143729 56403 63288887
Therapy non-responder 113.30 25.45 18 143714 75883 63269407
Symptom recurrence 113.27 25.45 63 143669 1747 63343543
Suicide attempt 113.16 25.45 6 143726 60912 63284378
Skin disorder 112.70 25.45 223 143509 29284 63316006
Gastrointestinal disorder 112.31 25.45 80 143652 131159 63214131
Drug hypersensitivity 111.63 25.45 347 143385 310340 63034950
Injury 110.18 25.45 17 143715 73230 63272060
General physical condition abnormal 109.40 25.45 85 143647 4189 63341101
Malaise 109.37 25.45 527 143205 415427 62929863
Cognitive disorder 108.60 25.45 4 143728 55811 63289479
Quality of life decreased 108.29 25.45 116 143616 8687 63336603
Type 2 diabetes mellitus 107.94 25.45 10 143722 63858 63281432
Tremor 107.52 25.45 85 143647 132154 63213136
Eosinophil count increased 105.52 25.45 127 143605 10801 63334489
Eosinophilic granulomatosis with polyangiitis 104.62 25.45 64 143668 2128 63343162
Medication error 104.39 25.45 3 143729 52281 63293009
Hypoglycaemia 102.60 25.45 9 143723 60056 63285234
Swelling 102.17 25.45 303 143429 275075 63070215
Intercepted product storage error 100.86 25.45 26 143706 62 63345228
Injection site inflammation 97.44 25.45 76 143656 3767 63341523
Eye allergy 94.85 25.45 46 143686 953 63344337
Sleep disorder due to general medical condition, insomnia type 94.37 25.45 6 143726 52211 63293079
Blood pressure systolic increased 93.61 25.45 3 143729 47394 63297896
Drug ineffective for unapproved indication 93.12 25.45 225 143507 33838 63311452
Neuropathy peripheral 92.48 25.45 73 143659 113594 63231696
Hypoxia 91.96 25.45 13 143719 59779 63285511
Middle insomnia 90.89 25.45 127 143605 12516 63332774
C-reactive protein abnormal 90.74 25.45 3 143729 46093 63299197
Cough 89.60 25.45 1035 142697 291708 63053582
Dizziness 89.49 25.45 588 143144 429337 62915953
Perioral dermatitis 87.75 25.45 30 143702 237 63345053
Agitation 87.34 25.45 15 143717 59742 63285548
Back pain 85.94 25.45 308 143424 263837 63081453
Suicidal ideation 84.24 25.45 19 143713 62402 63282888
Liver disorder 84.16 25.45 11 143721 53676 63291614
Myocardial infarction 84.01 25.45 62 143670 99831 63245459
Oropharyngeal pain 83.62 25.45 429 143303 94058 63251232
Rhabdomyolysis 82.68 25.45 4 143728 43947 63301343
Fibromyalgia 81.51 25.45 40 143692 80380 63264910
Syncope 78.41 25.45 90 143642 117295 63227995
Acne 78.29 25.45 167 143565 23126 63322164
Chest pain 77.64 25.45 241 143491 215718 63129572
Loss of consciousness 77.36 25.45 92 143640 118029 63227261
Therapeutic product effect decreased 77.21 25.45 205 143527 192982 63152308
Incorrect dose administered by device 77.18 25.45 70 143662 4278 63341012
Rectal haemorrhage 76.97 25.45 10 143722 49020 63296270
Red blood cell sedimentation rate increased 76.75 25.45 6 143726 43976 63301314
Blood pressure fluctuation 76.30 25.45 8 143724 46309 63298981
Gait disturbance 75.79 25.45 191 143541 182987 63162303
Hallucination 75.36 25.45 16 143716 54801 63290489
Blood alkaline phosphatase increased 74.59 25.45 6 143726 42961 63302329
Chronic kidney disease 74.38 25.45 8 143724 45390 63299900
Off label use 72.93 25.45 1082 142650 673380 62671910
Palpitations 72.61 25.45 89 143643 112681 63232609
Ill-defined disorder 72.37 25.45 48 143684 81707 63263583
Therapeutic response unexpected 71.91 25.45 142 143590 18617 63326673
Balance disorder 71.50 25.45 52 143680 84370 63260920
Drug dose omission by device 71.26 25.45 70 143662 4731 63340559
Multiple sclerosis relapse 71.22 25.45 12 143720 48466 63296824
Haematochezia 70.86 25.45 17 143715 53527 63291763
Conjunctivitis allergic 70.72 25.45 37 143695 905 63344385
Keratitis 70.58 25.45 60 143672 3362 63341928
Hand dermatitis 70.37 25.45 25 143707 224 63345066
Muscular weakness 70.24 25.45 105 143627 122248 63223042
Foreign body sensation in eyes 69.62 25.45 50 143682 2184 63343106
Hyperglycaemia 69.57 25.45 7 143725 41860 63303430
Oxygen saturation decreased 69.43 25.45 59 143673 88526 63256764
Skin depigmentation 68.68 25.45 37 143695 962 63344328
Red blood cell count decreased 67.01 25.45 7 143725 40638 63304652
Skin texture abnormal 66.81 25.45 29 143703 460 63344830
Femur fracture 66.80 25.45 8 143724 41748 63303542
Pulmonary fibrosis 65.26 25.45 7 143725 39802 63305488
Hepatic failure 64.72 25.45 4 143728 35652 63309638
Prescribed overdose 64.59 25.45 3 143729 34150 63311140
Adverse event 63.48 25.45 37 143695 67522 63277768
Dyspepsia 63.35 25.45 83 143649 102113 63243177
Heart rate decreased 63.25 25.45 13 143719 45547 63299743
Asthenopia 63.15 25.45 48 143684 2289 63343001
Blood glucose increased 62.97 25.45 58 143674 83698 63261592
Pain 62.94 25.45 1241 142491 739387 62605903
Orthostatic hypotension 62.91 25.45 5 143727 36155 63309135
Sunburn 61.88 25.45 51 143681 2737 63342553
Drug effective for unapproved indication 61.37 25.45 55 143677 3309 63341981
Respiratory arrest 61.31 25.45 3 143729 32642 63312648
Eosinophilic pneumonia 61.05 25.45 46 143686 2165 63343125
Joint range of motion decreased 60.84 25.45 3 143729 32425 63312865
Drug reaction with eosinophilia and systemic symptoms 60.81 25.45 4 143728 33832 63311458
Pulmonary oedema 60.80 25.45 24 143708 54849 63290441
Foetal exposure during pregnancy 59.83 25.45 3 143729 31959 63313331
Acute respiratory failure 59.35 25.45 5 143727 34480 63310810
Dysphagia 57.99 25.45 69 143663 88516 63256774
Blood pressure decreased 57.78 25.45 38 143694 64984 63280306
Periorbital inflammation 57.77 25.45 16 143716 55 63345235
Coronary artery disease 57.68 25.45 4 143728 32373 63312917
Hypothyroidism 57.48 25.45 13 143719 42619 63302671
Scab 57.32 25.45 79 143653 7684 63337606
Haematemesis 56.47 25.45 3 143729 30409 63314881
Lymphocyte count decreased 56.13 25.45 3 143729 30254 63315036
Transaminases increased 55.52 25.45 4 143728 31363 63313927
Osteoporosis 54.45 25.45 31 143701 57307 63287983
Acute myocardial infarction 54.36 25.45 5 143727 32119 63313171
Dyskinesia 54.10 25.45 5 143727 31997 63313293
Generalised tonic-clonic seizure 53.44 25.45 3 143729 29013 63316277
Pneumonitis 53.36 25.45 8 143724 35214 63310076
Heart rate increased 53.00 25.45 82 143650 94156 63251134
Cholelithiasis 52.44 25.45 17 143715 43908 63301382
Disorientation 51.28 25.45 13 143719 39439 63305851
Liver function test increased 50.76 25.45 7 143725 32804 63312486
Pulmonary hypertension 50.69 25.45 11 143721 37112 63308178
Product quality issue 50.27 25.45 10 143722 35855 63309435
Gastrooesophageal reflux disease 50.25 25.45 87 143645 95552 63249738
Amnesia 50.05 25.45 32 143700 55553 63289737
Hypervolaemia 49.23 25.45 4 143728 28409 63316881
Depression 49.19 25.45 253 143479 196239 63149051
Product administered at inappropriate site 48.78 25.45 47 143685 3102 63342188
Arrhythmia 48.75 25.45 13 143719 38127 63307163
Respiratory distress 48.57 25.45 9 143723 33942 63311348
Haematuria 48.12 25.45 5 143727 29152 63316138
Anosmia 47.96 25.45 68 143664 6792 63338498
Blood calcium decreased 47.91 25.45 3 143729 26448 63318842
Hypophagia 47.59 25.45 7 143725 31252 63314038
Product temperature excursion issue 47.23 25.45 18 143714 200 63345090
Pancreatitis acute 46.58 25.45 4 143728 27162 63318128
Dyspnoea 46.36 25.45 1142 142590 660171 62685119
Full blood count abnormal 46.26 25.45 8 143724 31709 63313581
Maternal exposure during pregnancy 45.16 25.45 302 143430 219760 63125530
Dyspnoea exertional 45.04 25.45 42 143690 60260 63285030
Sinus operation 44.66 25.45 41 143691 2545 63342745
Aphasia 44.61 25.45 10 143722 32990 63312300
Rosacea 44.51 25.45 54 143678 4630 63340660
Cerebral haemorrhage 44.28 25.45 8 143724 30721 63314569
Osteonecrosis 43.79 25.45 3 143729 24527 63320763
Dysarthria 43.65 25.45 21 143711 42690 63302600
Colitis 43.61 25.45 28 143704 48500 63296790
Psychotic disorder 43.51 25.45 4 143728 25708 63319582
Intentional self-injury 43.46 25.45 4 143728 25683 63319607
Urinary retention 43.42 25.45 8 143724 30293 63314997
Bursitis 43.06 25.45 15 143717 37026 63308264
Injury associated with device 42.80 25.45 47 143685 3619 63341671
Skin erosion 42.39 25.45 40 143692 2572 63342718
Anxiety 41.95 25.45 304 143428 217237 63128053
Lethargy 41.84 25.45 39 143693 55968 63289322
Pigmentation disorder 41.69 25.45 52 143680 4587 63340703
Acute respiratory distress syndrome 41.66 25.45 3 143729 23531 63321759
Full blood count decreased 41.59 25.45 5 143727 26019 63319271
Aggression 41.58 25.45 3 143729 23495 63321795
Respiration abnormal 41.06 25.45 61 143671 6356 63338934
White blood cell count increased 41.00 25.45 30 143702 48531 63296759
Foot deformity 40.68 25.45 7 143725 27846 63317444
Fluid retention 40.67 25.45 45 143687 59641 63285649
Periorbital pain 40.25 25.45 12 143720 57 63345233
Sneezing 40.16 25.45 111 143621 18107 63327183
Pharyngeal swelling 39.73 25.45 60 143672 6344 63338946
Stress 39.46 25.45 274 143458 66893 63278397
Osteomyelitis 39.21 25.45 6 143726 26014 63319276
Cerebrovascular accident 39.18 25.45 120 143612 107904 63237386
Metastases to liver 39.15 25.45 4 143728 23635 63321655
Epilepsy 39.10 25.45 7 143725 27058 63318232
Hepatic cirrhosis 38.93 25.45 5 143727 24729 63320561
Angina pectoris 38.92 25.45 10 143722 30068 63315222
Urinary incontinence 38.91 25.45 12 143720 32002 63313288
Basal cell carcinoma 38.82 25.45 8 143724 27983 63317307
Shock 38.78 25.45 4 143728 23459 63321831
Emotional distress 38.15 25.45 13 143719 32536 63312754
Pancreatitis 38.03 25.45 33 143699 49022 63296268
Pallor 37.98 25.45 11 143721 30557 63314733
Drainage 37.67 25.45 15 143717 189 63345101
Product used for unknown indication 37.40 25.45 20 143712 512 63344778
Blood pressure diastolic decreased 37.20 25.45 4 143728 22702 63322588
Pulmonary arterial hypertension 36.93 25.45 4 143728 22573 63322717
Injection site scar 36.91 25.45 25 143707 993 63344297
Blood potassium decreased 36.75 25.45 25 143707 42001 63303289
Nasal polypectomy 36.42 25.45 10 143722 33 63345257
Abdominal pain lower 36.32 25.45 7 143725 25671 63319619
Gastroenteritis 36.06 25.45 8 143724 26582 63318708
Keratoconus 35.67 25.45 9 143723 19 63345271
Frequent bowel movements 35.41 25.45 5 143727 23017 63322273
Night sweats 35.29 25.45 35 143697 48779 63296511
Rash maculo-papular 35.25 25.45 14 143718 31882 63313408
Injection site extravasation 35.19 25.45 68 143664 8773 63336517
Device leakage 35.14 25.45 60 143672 7036 63338254
Disease recurrence 34.99 25.45 10 143722 28020 63317270
Pregnancy 34.85 25.45 20 143712 36816 63308474
Cystitis 34.75 25.45 44 143688 54947 63290343
Hepatic steatosis 34.58 25.45 11 143721 28758 63316532
Injection site nodule 34.48 25.45 43 143689 3792 63341498
Body temperature increased 34.05 25.45 21 143711 37171 63308119
Red blood cell sedimentation rate abnormal 33.68 25.45 3 143729 19779 63325511
SARS-CoV-1 test positive 33.67 25.45 9 143723 26 63345264
Circulatory collapse 33.19 25.45 5 143727 21933 63323357
Device dispensing error 32.97 25.45 12 143720 116 63345174
Facial discomfort 32.96 25.45 11 143721 80 63345210
Laboratory test abnormal 32.86 25.45 10 143722 26902 63318388
Stevens-Johnson syndrome 32.86 25.45 8 143724 24942 63320348
Miliaria 32.64 25.45 25 143707 1206 63344084
Nightmare 32.44 25.45 3 143729 19191 63326099
Nasal congestion 32.40 25.45 257 143475 65403 63279887
Hip arthroplasty 32.38 25.45 36 143696 47610 63297680
Dysuria 32.38 25.45 18 143714 33720 63311570
Proteinuria 32.34 25.45 3 143729 19142 63326148
Cutaneous T-cell lymphoma 32.22 25.45 26 143706 1354 63343936
Abnormal behaviour 32.15 25.45 5 143727 21421 63323869
Hyposmia 32.11 25.45 20 143712 687 63344603
Cellulitis 31.93 25.45 88 143644 81870 63263420
Pericardial effusion 31.92 25.45 14 143718 30044 63315246
Electrolyte imbalance 31.74 25.45 4 143728 20072 63325218
Upper gastrointestinal haemorrhage 31.72 25.45 3 143729 18849 63326441
Skin mass 31.68 25.45 52 143680 5903 63339387
Lack of administration site rotation 31.67 25.45 8 143724 17 63345273
Abdominal pain upper 31.43 25.45 307 143425 206137 63139153
Dysgeusia 30.97 25.45 36 143696 46674 63298616
Exposure during pregnancy 30.75 25.45 509 143223 155038 63190252
Angioedema 30.71 25.45 38 143694 47927 63297363
Lymphopenia 30.62 25.45 3 143729 18324 63326966
Eyelid thickening 30.54 25.45 10 143722 68 63345222
Paranasal sinus discomfort 30.03 25.45 43 143689 4333 63340957
Wound infection 29.94 25.45 6 143726 21404 63323886
Bone disorder 29.77 25.45 6 143726 21320 63323970
Mental disorder 29.75 25.45 127 143605 25792 63319498
Device operational issue 29.68 25.45 14 143718 272 63345018
Post-acute COVID-19 syndrome 29.56 25.45 16 143716 420 63344870
Haemoptysis 29.54 25.45 14 143718 28712 63316578
Haemorrhoids 29.37 25.45 7 143725 22143 63323147
Leukocytosis 29.30 25.45 11 143721 25924 63319366
Cerebral infarction 28.96 25.45 9 143723 23884 63321406
Drug tolerance decreased 28.82 25.45 3 143729 17470 63327820
Abdominal distension 28.78 25.45 100 143632 86515 63258775
Transient ischaemic attack 28.54 25.45 26 143706 37727 63307563
Tooth disorder 28.53 25.45 14 143718 28143 63317147
Injection site hypersensitivity 28.23 25.45 29 143703 2068 63343222
Coagulopathy 28.23 25.45 6 143726 20538 63324752
Small intestinal obstruction 28.16 25.45 4 143728 18333 63326957
Haemorrhage 28.13 25.45 60 143672 60962 63284328
Blood potassium increased 28.10 25.45 4 143728 18305 63326985
Lung disorder 28.05 25.45 62 143670 62199 63283091
Dandruff 28.02 25.45 13 143719 243 63345047
Joint effusion 27.96 25.45 3 143729 17057 63328233
Body temperature decreased 27.78 25.45 6 143726 20313 63324977
Upper-airway cough syndrome 27.61 25.45 72 143660 11346 63333944
Injection site indentation 27.55 25.45 12 143720 192 63345098
Neck pain 27.33 25.45 74 143658 69244 63276046
Photophobia 27.29 25.45 95 143637 17540 63327750
Muscle spasms 26.91 25.45 225 143507 155925 63189365
Hyperhidrosis 26.88 25.45 139 143593 107697 63237593
Treatment noncompliance 26.71 25.45 27 143705 37298 63307992
Infection 26.62 25.45 362 143370 228811 63116479
Obstructive airways disorder 26.56 25.45 7 143725 20692 63324598
Menstrual disorder 26.41 25.45 45 143687 5268 63340022
Haematoma 26.30 25.45 24 143708 34796 63310494
Chronic obstructive pulmonary disease 26.18 25.45 65 143667 62621 63282669
Bacteraemia 26.14 25.45 4 143728 17344 63327946
Flatulence 26.11 25.45 24 143708 34678 63310612
Knee operation 26.11 25.45 48 143684 5965 63339325
Disability 25.96 25.45 5 143727 18342 63326948
Pustule 25.64 25.45 25 143707 1674 63343616
Menstruation irregular 25.62 25.45 52 143680 6952 63338338
Serum sickness 25.61 25.45 32 143700 2828 63342462
Myoclonus 25.48 25.45 3 143729 15865 63329425

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
Product use in unapproved indication 7644.01 33.57 4201 77195 113298 34762237
Pruritus 4283.10 33.57 3129 78267 138852 34736683
Product dose omission issue 4090.86 33.57 2848 78548 116863 34758672
Injection site pain 4040.60 33.57 1917 79479 37088 34838447
Product use issue 3133.88 33.57 1903 79493 61313 34814222
Eczema 2878.01 33.57 1209 80187 17227 34858308
Dry eye 2812.52 33.57 995 80401 8580 34866955
Dry skin 2659.52 33.57 1345 80051 29942 34845593
Rash 2612.34 33.57 2881 78515 219871 34655664
Eye pruritus 2301.18 33.57 805 80591 6684 34868851
Conjunctivitis 2158.72 33.57 822 80574 8883 34866652
Ocular hyperaemia 2133.85 33.57 853 80543 10599 34864936
Injection site swelling 2111.12 33.57 848 80548 10679 34864856
Eye irritation 1824.95 33.57 680 80716 6881 34868654
Product dose omission in error 1739.83 33.57 491 80905 1783 34873752
Impaired quality of life 1663.58 33.57 593 80803 5225 34870310
Inappropriate schedule of product administration 1616.56 33.57 1260 80136 61036 34814499
Skin exfoliation 1538.50 33.57 896 80500 26536 34848999
Sleep disorder 1312.34 33.57 853 80543 30835 34844700
Injection site erythema 1129.84 33.57 607 80789 15292 34860243
Drug ineffective 1109.16 33.57 2915 78481 453836 34421699
Therapeutic response decreased 1087.59 33.57 737 80659 28576 34846959
Therapeutic response shortened 1006.99 33.57 441 80955 6963 34868572
Discomfort 932.01 33.57 569 80827 18369 34857166
Skin fissures 931.51 33.57 378 81018 4881 34870654
COVID-19 853.62 33.57 975 80421 76575 34798960
Incorrect dose administered 761.58 33.57 681 80715 39834 34835701
Erythema 755.47 33.57 980 80416 87800 34787735
Product prescribing issue 702.59 33.57 243 81153 1936 34873599
Injection site pruritus 701.47 33.57 337 81059 6646 34868889
Lacrimation increased 688.13 33.57 354 81042 8128 34867407
Acute kidney injury 664.88 33.57 9 81387 304979 34570556
Injection site rash 609.18 33.57 261 81135 3892 34871643
Arthralgia 599.16 33.57 1260 80136 168781 34706754
Condition aggravated 577.61 33.57 1336 80060 190860 34684675
Vision blurred 576.02 33.57 619 80777 45344 34830191
Injection site urticaria 557.44 33.57 202 81194 1870 34873665
Skin haemorrhage 547.73 33.57 251 81145 4427 34871108
Product preparation error 546.33 33.57 205 81191 2112 34873423
Injection site reaction 539.26 33.57 351 81045 12682 34862853
Rash macular 531.70 33.57 346 81050 12496 34863039
Death 514.79 33.57 146 81250 397903 34477632
Drug effect less than expected 505.45 33.57 165 81231 1076 34874459
Anaemia 476.19 33.57 15 81381 233320 34642215
Illness 456.19 33.57 321 81075 13208 34862327
Injection site bruising 456.18 33.57 272 81124 8391 34867144
Accidental exposure to product 455.65 33.57 314 81082 12488 34863047
Skin burning sensation 450.94 33.57 219 81177 4424 34871111
Drug interaction 445.59 33.57 19 81377 225927 34649608
Toxicity to various agents 444.82 33.57 4 81392 200358 34675177
Device use issue 427.59 33.57 125 81271 529 34875006
Injection site mass 423.45 33.57 236 81160 6390 34869145
Product storage error 422.43 33.57 253 81143 7869 34867666
Oral herpes 399.97 33.57 214 81182 5333 34870202
Eye discharge 378.67 33.57 151 81245 1855 34873680
Rash erythematous 371.53 33.57 369 81027 24608 34850927
Diarrhoea 369.11 33.57 227 81169 389685 34485850
Hypotension 367.62 33.57 43 81353 221606 34653929
Skin weeping 352.20 33.57 101 81295 393 34875142
Intentional dose omission 348.67 33.57 168 81228 3332 34872203
Scratch 346.59 33.57 165 81231 3183 34872352
Skin swelling 333.59 33.57 124 81272 1241 34874294
Dermatitis atopic 332.29 33.57 187 81209 5160 34870375
Pneumonia 320.21 33.57 228 81168 362399 34513136
Thrombocytopenia 311.64 33.57 12 81384 156235 34719300
Periorbital swelling 305.87 33.57 96 81300 541 34874994
Rebound eczema 293.78 33.57 58 81338 0 34875535
Skin irritation 293.31 33.57 175 81221 5402 34870133
Blepharitis 291.05 33.57 114 81282 1331 34874204
Extra dose administered 289.97 33.57 155 81241 3854 34871681
Neutropenia 284.82 33.57 21 81375 156757 34718778
Rebound atopic dermatitis 278.59 33.57 55 81341 0 34875535
Dermatitis 274.38 33.57 205 81191 9263 34866272
Eyelid margin crusting 272.97 33.57 72 81324 187 34875348
Eyelids pruritus 269.46 33.57 66 81330 111 34875424
Sepsis 269.42 33.57 35 81361 166526 34709009
Eye pain 268.00 33.57 234 81162 13228 34862307
Vomiting 255.66 33.57 129 81267 247492 34628043
Eye swelling 251.52 33.57 199 81197 9796 34865739
Erythema of eyelid 249.97 33.57 91 81305 854 34874681
Nausea 248.29 33.57 256 81140 339652 34535883
Platelet count decreased 246.42 33.57 7 81389 119710 34755825
Renal failure 232.82 33.57 19 81377 130538 34744997
Eye disorder 229.72 33.57 185 81211 9343 34866192
Haemoglobin decreased 225.65 33.57 14 81382 120758 34754777
Respiratory failure 221.07 33.57 7 81389 108565 34766970
Lack of injection site rotation 219.93 33.57 60 81336 185 34875350
Injection site irritation 216.12 33.57 89 81307 1194 34874341
Asthenia 213.69 33.57 156 81240 245095 34630440
Dehydration 213.29 33.57 26 81370 129943 34745592
Confusional state 213.26 33.57 39 81357 144121 34731414
Eye inflammation 207.50 33.57 102 81294 2116 34873419
Off label use of device 205.62 33.57 45 81351 29 34875506
General physical health deterioration 202.49 33.57 29 81367 128240 34747295
Pancytopenia 201.80 33.57 4 81392 95153 34780382
Eyelid skin dryness 187.36 33.57 42 81354 35 34875500
Swelling of eyelid 186.91 33.57 77 81319 1034 34874501
Visual impairment 186.11 33.57 314 81082 35488 34840047
Abdominal pain 184.66 33.57 75 81321 163543 34711992
Completed suicide 184.50 33.57 11 81385 98157 34777378
Injection site vesicles 183.59 33.57 68 81328 673 34874862
SARS-CoV-2 test positive 182.10 33.57 133 81263 5800 34869735
Overdose 181.41 33.57 7 81389 91052 34784483
Injection site discomfort 180.98 33.57 84 81312 1526 34874009
Cardiac arrest 180.04 33.57 11 81385 96148 34779387
Fear of injection 174.54 33.57 81 81315 1471 34874064
Blood creatinine increased 174.45 33.57 12 81384 94964 34780571
Disease progression 171.57 33.57 24 81372 108053 34767482
White blood cell count decreased 167.07 33.57 15 81381 95430 34780105
Decreased appetite 165.15 33.57 91 81305 166301 34709234
Multiple organ dysfunction syndrome 163.22 33.57 3 81393 76563 34798972
Gastrointestinal haemorrhage 163.02 33.57 11 81385 88466 34787069
Constipation 162.51 33.57 58 81338 136924 34738611
Renal impairment 159.79 33.57 17 81379 94496 34781039
Fall 159.20 33.57 143 81253 202742 34672793
Alanine aminotransferase increased 152.01 33.57 9 81387 80806 34794729
Acne 150.79 33.57 156 81240 10910 34864625
Skin disorder 144.57 33.57 168 81228 13387 34862148
Ocular discomfort 144.54 33.57 79 81317 2055 34873480
Bradycardia 143.07 33.57 8 81388 75410 34800125
Wrong technique in device usage process 142.84 33.57 70 81326 1442 34874093
Skin discolouration 142.03 33.57 191 81205 17654 34857881
Oedema peripheral 141.63 33.57 51 81345 119761 34755774
Septic shock 141.46 33.57 6 81390 71828 34803707
Skin discomfort 139.81 33.57 38 81358 115 34875420
Burning sensation 139.02 33.57 192 81204 18202 34857333
Tachycardia 138.91 33.57 17 81379 84755 34790780
Cardiac failure 136.35 33.57 24 81372 91224 34784311
Eyelid irritation 133.21 33.57 35 81361 89 34875446
Hyperkalaemia 132.74 33.57 7 81389 69382 34806153
Pleural effusion 132.04 33.57 17 81379 81529 34794006
Leukopenia 131.82 33.57 3 81393 62853 34812682
Cardiac failure congestive 130.95 33.57 19 81377 83251 34792284
Atrial fibrillation 127.21 33.57 63 81333 122330 34753205
Pulmonary embolism 126.92 33.57 27 81369 89719 34785816
Seizure 126.73 33.57 43 81353 104814 34770721
Aspartate aminotransferase increased 126.11 33.57 8 81388 67775 34807760
Device defective 121.81 33.57 51 81345 715 34874820
Hypokalaemia 121.23 33.57 3 81393 58211 34817324
Rhabdomyolysis 121.21 33.57 10 81386 68153 34807382
Interstitial lung disease 120.58 33.57 8 81388 65274 34810261
Hypertension 119.65 33.57 86 81310 136357 34739178
Symptom recurrence 112.63 33.57 48 81348 705 34874830
Eye infection 111.95 33.57 82 81314 3591 34871944
Hordeolum 111.93 33.57 53 81343 1009 34874526
Weight decreased 109.91 33.57 150 81246 176151 34699384
Asthma 109.72 33.57 280 81116 42376 34833159
Rash pruritic 109.03 33.57 212 81184 26729 34848806
Hypersensitivity 108.74 33.57 351 81045 60684 34814851
Hypoxia 104.00 33.57 6 81390 55089 34820446
Deep vein thrombosis 102.31 33.57 15 81381 65233 34810302
Sneezing 102.05 33.57 90 81306 5152 34870383
Eyelid rash 101.73 33.57 24 81372 31 34875504
Neutrophil count decreased 101.50 33.57 4 81392 51100 34824435
Therapeutic response unexpected 100.83 33.57 119 81277 9638 34865897
Urticaria 98.96 33.57 345 81051 62032 34813503
Eczema eyelids 98.70 33.57 23 81373 27 34875508
Rhinorrhoea 97.85 33.57 197 81199 25471 34850064
Injection site haemorrhage 97.43 33.57 117 81279 9651 34865884
Syncope 96.62 33.57 46 81350 91405 34784130
Periorbital irritation 96.24 33.57 19 81377 0 34875535
Acute myocardial infarction 95.17 33.57 8 81388 53711 34821824
Needle issue 95.16 33.57 93 81303 6072 34869463
Ascites 94.75 33.57 3 81393 46568 34828967
Unintentional use for unapproved indication 94.59 33.57 20 81376 8 34875527
Haematuria 92.85 33.57 6 81390 50060 34825475
Anosmia 92.48 33.57 76 81320 3948 34871587
Pyrexia 91.44 33.57 432 80964 332581 34542954
Tremor 91.22 33.57 39 81357 82548 34792987
Neuropathy peripheral 90.89 33.57 40 81356 83223 34792312
Agitation 90.45 33.57 13 81383 57386 34818149
Injection site discolouration 89.47 33.57 51 81345 1442 34874093
Urinary tract infection 89.27 33.57 42 81354 84039 34791496
C-reactive protein increased 88.23 33.57 11 81385 54087 34821448
Hallucination 87.68 33.57 9 81387 51489 34824046
Nasal congestion 86.75 33.57 176 81220 22881 34852654
Hepatic function abnormal 86.35 33.57 4 81392 44359 34831176
Coma 86.14 33.57 5 81391 45673 34829862
Blood pressure increased 86.13 33.57 49 81347 88053 34787482
Drug ineffective for unapproved indication 85.66 33.57 178 81218 23537 34851998
Surgery 85.55 33.57 133 81263 14024 34861511
Blood pressure decreased 85.18 33.57 10 81386 51505 34824030
Hospitalisation 84.50 33.57 308 81088 56594 34818941
Blood creatine phosphokinase increased 84.31 33.57 5 81391 44852 34830683
Coronary artery disease 83.40 33.57 8 81388 48297 34827238
Keratitis 82.77 33.57 48 81348 1403 34874132
Pneumonia aspiration 80.85 33.57 4 81392 41899 34833636
Somnolence 80.42 33.57 84 81312 111032 34764503
Myocardial infarction 79.54 33.57 99 81297 120986 34754549
Eye allergy 78.77 33.57 20 81376 42 34875493
Hyperglycaemia 78.71 33.57 3 81393 39477 34836058
Eosinophil count increased 74.78 33.57 96 81300 8476 34867059
Oxygen saturation decreased 74.43 33.57 17 81379 53801 34821734
Blood bilirubin increased 72.80 33.57 4 81392 38292 34837243
Loss of consciousness 72.55 33.57 52 81344 82615 34792920
Plasma cell myeloma 72.47 33.57 7 81389 42030 34833505
Alopecia 72.33 33.57 169 81227 24186 34851349
Injection site dryness 72.04 33.57 17 81379 22 34875513
Scab 71.45 33.57 70 81326 4584 34870951
Intentional product use issue 71.42 33.57 25 81371 59791 34815744
Chronic kidney disease 70.68 33.57 7 81389 41203 34834332
Incorrect dose administered by device 69.45 33.57 47 81349 1811 34873724
Suicide attempt 68.81 33.57 6 81390 39110 34836425
Rectal haemorrhage 68.60 33.57 7 81389 40242 34835293
Urinary retention 68.33 33.57 4 81392 36284 34839251
Eyelid exfoliation 68.20 33.57 14 81382 3 34875532
Respiratory distress 66.95 33.57 4 81392 35661 34839874
Blood glucose increased 66.80 33.57 36 81360 66682 34808853
Pulmonary oedema 63.78 33.57 16 81380 47513 34828022
Nasopharyngitis 63.21 33.57 326 81070 69642 34805893
Sinusitis 61.36 33.57 224 81172 41178 34834357
Drug intolerance 61.33 33.57 31 81365 59539 34815996
Melaena 60.70 33.57 6 81390 35374 34840161
Cutaneous T-cell lymphoma 60.12 33.57 40 81356 1498 34874037
Blood alkaline phosphatase increased 60.06 33.57 3 81393 31172 34844363
Angioedema 59.97 33.57 8 81388 37366 34838169
Liver function test abnormal 59.84 33.57 3 81393 31071 34844464
Drug effective for unapproved indication 59.50 33.57 49 81347 2553 34872982
Dysarthria 59.41 33.57 6 81390 34776 34840759
Jaundice 58.58 33.57 4 81392 31878 34843657
Drug reaction with eosinophilia and systemic symptoms 58.24 33.57 5 81391 33007 34842528
Sensitive skin 58.20 33.57 28 81368 553 34874982
Haematochezia 58.09 33.57 18 81378 46516 34829019
Muscular weakness 57.50 33.57 51 81345 72846 34802689
Eosinophilic granulomatosis with polyangiitis 57.50 33.57 43 81353 1944 34873591
Pneumonitis 57.46 33.57 6 81390 33872 34841663
Conjunctivitis allergic 57.09 33.57 35 81361 1135 34874400
Unevaluable event 56.71 33.57 186 81210 32404 34843131
Acute respiratory failure 56.48 33.57 4 81392 30924 34844611
Gamma-glutamyltransferase increased 55.72 33.57 3 81393 29228 34846307
Cough 53.25 33.57 559 80837 149581 34725954
Foreign body sensation in eyes 52.95 33.57 27 81369 607 34874928
Oropharyngeal pain 52.59 33.57 192 81204 35293 34840242
Cerebral haemorrhage 52.57 33.57 9 81387 34928 34840607
Aggression 52.51 33.57 13 81383 38951 34836584
Keratoconus 52.17 33.57 17 81379 110 34875425
Angina pectoris 52.06 33.57 6 81390 31357 34844178
Drug-induced liver injury 51.88 33.57 4 81392 28828 34846707
Suicidal ideation 51.55 33.57 15 81381 40373 34835162
Product administered at inappropriate site 50.90 33.57 42 81354 2194 34873341
Miliaria 50.57 33.57 25 81371 525 34875010
Arrhythmia 50.13 33.57 11 81385 35797 34839738
Ventricular tachycardia 49.83 33.57 3 81393 26576 34848959
Paternal exposure during pregnancy 49.22 33.57 13 81383 34 34875501
Liver disorder 48.56 33.57 9 81387 32988 34842547
Nasal polypectomy 48.03 33.57 10 81386 3 34875532
Red blood cell count decreased 47.22 33.57 6 81390 29084 34846451
General physical condition abnormal 47.20 33.57 51 81345 3748 34871787
Treatment failure 47.03 33.57 25 81371 46672 34828863
Haematemesis 46.76 33.57 5 81391 27706 34847829
Ocular surface disease 46.66 33.57 14 81382 66 34875469
Pain of skin 46.49 33.57 64 81332 6045 34869490
Colitis 46.41 33.57 15 81381 37735 34837800
Hyposmia 46.03 33.57 18 81378 209 34875326
Hepatic enzyme increased 45.51 33.57 17 81379 39063 34836472
Drug dose omission by device 44.70 33.57 39 81357 2200 34873335
Drug dependence 44.61 33.57 3 81393 24214 34851321
Facial discomfort 44.48 33.57 12 81384 35 34875500
Chest pain 44.44 33.57 149 81247 126613 34748922
Hand-foot-and-mouth disease 44.29 33.57 14 81382 81 34875454
Pharyngitis streptococcal 44.27 33.57 42 81354 2642 34872893
Superficial injury of eye 44.23 33.57 12 81384 36 34875499
Hepatitis 43.92 33.57 3 81393 23901 34851634
Oedema 43.88 33.57 26 81370 45715 34829820
Injection site inflammation 43.62 33.57 27 81369 891 34874644
Fatigue 43.54 33.57 605 80791 370048 34505487
Injection site warmth 43.36 33.57 37 81359 2025 34873510
Haemoptysis 42.88 33.57 14 81382 34992 34840543
Knee operation 42.82 33.57 37 81359 2060 34873475
Spinal operation 42.82 33.57 43 81353 2901 34872634
Therapy non-responder 42.39 33.57 19 81377 39127 34836408
Dyspnoea exertional 42.37 33.57 24 81372 43255 34832280
Depression 42.20 33.57 103 81293 96995 34778540
Heart rate decreased 41.99 33.57 11 81385 31734 34843801
Shock 41.74 33.57 4 81392 24175 34851360
Pustule 41.58 33.57 22 81374 535 34875000
Periorbital pain 41.52 33.57 10 81386 15 34875520
Cerebral infarction 41.47 33.57 7 81389 27448 34848087
Abdominal distension 41.41 33.57 45 81351 58447 34817088
Disorientation 41.13 33.57 13 81383 33175 34842360
Injury associated with device 41.01 33.57 28 81368 1095 34874440
Rheumatoid arthritis 40.72 33.57 19 81377 38219 34837316
Dyskinesia 40.63 33.57 3 81393 22410 34853125
Cholestasis 40.41 33.57 7 81389 26941 34848594
Food allergy 40.40 33.57 31 81365 1457 34874078
Asthenopia 40.25 33.57 22 81374 572 34874963
Photophobia 40.10 33.57 64 81332 6900 34868635
Medication error 39.78 33.57 6 81390 25559 34849976
Injection site exfoliation 39.71 33.57 10 81386 20 34875515
Sinus operation 39.61 33.57 23 81373 674 34874861
Pigmentation disorder 39.52 33.57 38 81358 2431 34873104
Blister 39.35 33.57 130 81266 22728 34852807
Blood pressure systolic increased 39.09 33.57 4 81392 22948 34852587
Eczema herpeticum 39.00 33.57 15 81381 166 34875369
Altered state of consciousness 38.96 33.57 4 81392 22889 34852646
Cognitive disorder 37.84 33.57 10 81386 28683 34846852
Chills 37.60 33.57 83 81313 80960 34794575
Pulmonary hypertension 37.37 33.57 3 81393 20921 34854614
Rash maculo-papular 37.36 33.57 10 81386 28441 34847094
Musculoskeletal pain 37.06 33.57 14 81382 31949 34843586
Dyspnoea 36.77 33.57 637 80759 376145 34499390
Pancreatitis acute 36.75 33.57 10 81386 28131 34847404
Dysuria 36.70 33.57 9 81387 27143 34848392
Sinus disorder 36.59 33.57 62 81334 7023 34868512
Intestinal obstruction 36.34 33.57 5 81391 22817 34852718
Pancreatitis 36.06 33.57 23 81373 38868 34836667
Injection site discharge 35.53 33.57 15 81381 215 34875320
Product temperature excursion issue 35.50 33.57 11 81385 59 34875476
Restlessness 35.32 33.57 8 81388 25474 34850061
Dandruff 35.28 33.57 15 81381 219 34875316
Molluscum contagiosum 35.22 33.57 16 81380 276 34875259
Cholelithiasis 35.21 33.57 4 81392 21144 34854391
Quality of life decreased 35.20 33.57 45 81351 3956 34871579
Heart rate increased 34.67 33.57 34 81362 46309 34829226
Malaise 34.58 33.57 272 81124 185553 34689982
Eyelid thickening 34.51 33.57 8 81388 9 34875526
Haematoma 33.62 33.57 9 81387 25596 34849939
Laboratory test abnormal 33.60 33.57 4 81392 20387 34855148

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
Product use in unapproved indication 15124.40 25.01 7999 145856 242360 79348173
Product dose omission issue 8367.92 25.01 5446 148409 242091 79348442
Injection site pain 7295.21 25.01 3970 149885 125868 79464665
Pruritus 6044.73 25.01 5417 148438 389231 79201302
Product use issue 5947.94 25.01 4145 149710 205677 79384856
Eczema 4550.26 25.01 1997 151858 38821 79551712
Eye pruritus 4244.12 25.01 1568 152287 19002 79571531
Dry skin 4213.56 25.01 2223 151632 65772 79524761
Dry eye 4165.19 25.01 1822 152033 35109 79555424
Rash 3701.42 25.01 5024 148831 573334 79017199
Ocular hyperaemia 3086.85 25.01 1363 152492 26843 79563690
Impaired quality of life 3060.42 25.01 1122 152733 13264 79577269
Eye irritation 3024.54 25.01 1228 152627 19453 79571080
Injection site swelling 3017.68 25.01 1576 152279 45556 79544977
Skin exfoliation 2757.02 25.01 1565 152290 53535 79536998
Product dose omission in error 2723.27 25.01 881 152974 6907 79583626
Conjunctivitis 2383.66 25.01 1107 152748 24608 79565925
Injection site erythema 2352.48 25.01 1607 152248 76590 79513943
Inappropriate schedule of product administration 2301.43 25.01 1969 151886 131659 79458874
COVID-19 2095.16 25.01 2008 151847 155666 79434867
Sleep disorder 1860.72 25.01 1446 152409 84231 79506302
Incorrect dose administered 1826.18 25.01 1367 152488 75263 79515270
Injection site rash 1651.37 25.01 769 153086 17185 79573348
Therapeutic response shortened 1417.28 25.01 666 153189 15197 79575336
Injection site pruritus 1409.87 25.01 927 152928 41356 79549177
Skin fissures 1346.88 25.01 606 153249 12467 79578066
Therapeutic response decreased 1256.20 25.01 1037 152818 65816 79524717
Product preparation error 1239.55 25.01 454 153401 5339 79585194
Injection site urticaria 1168.93 25.01 546 153309 12280 79578253
Injection site reaction 1150.43 25.01 907 152948 53878 79536655
Accidental exposure to product 1133.28 25.01 723 153132 30599 79559934
Product prescribing issue 1062.14 25.01 369 153486 3676 79586857
Skin burning sensation 1045.07 25.01 511 153344 12761 79577772
Rash macular 1003.29 25.01 650 153205 28249 79562284
Erythema 1000.06 25.01 1649 152206 221641 79368892
Vision blurred 941.83 25.01 1090 152765 104808 79485725
Acute kidney injury 931.51 25.01 14 153841 519390 79071143
Lacrimation increased 901.52 25.01 554 153301 21923 79568610
Injection site bruising 869.63 25.01 683 153172 40319 79550214
Oral herpes 838.12 25.01 570 153285 26884 79563649
Product storage error 808.12 25.01 460 153395 15766 79574767
Toxicity to various agents 784.97 25.01 5 153850 421535 79168998
Rash erythematous 762.22 25.01 734 153121 57035 79533498
Skin haemorrhage 707.40 25.01 380 153475 11601 79578932
Illness 704.13 25.01 638 153217 45873 79544660
Drug ineffective 699.49 25.01 3995 149860 1076918 78513615
Device use issue 696.50 25.01 245 153610 2539 79587994
Anaemia 689.02 25.01 43 153812 444972 79145561
Condition aggravated 687.05 25.01 2324 151531 498800 79091733
Eye discharge 683.42 25.01 299 153556 5735 79584798
Discomfort 665.84 25.01 1003 152852 124614 79465919
Dermatitis atopic 653.36 25.01 340 153515 9716 79580817
Drug interaction 640.05 25.01 41 153814 415142 79175391
Diarrhoea 636.30 25.01 465 153390 880024 78710509
Eye pain 603.48 25.01 533 153322 37045 79553488
Hypotension 599.34 25.01 73 153782 440244 79150289
Skin swelling 598.88 25.01 242 153613 3772 79586761
Injection site mass 575.79 25.01 402 153453 19782 79570751
Intentional dose omission 561.08 25.01 294 153561 8523 79582010
Death 547.48 25.01 205 153650 566309 79024224
Eye swelling 537.72 25.01 430 153425 26038 79564495
Vomiting 535.59 25.01 311 153544 665517 78925016
Arthralgia 534.60 25.01 2349 151506 569454 79021079
SARS-CoV-2 test positive 524.59 25.01 310 153545 11406 79579127
Blepharitis 499.56 25.01 198 153657 2926 79587607
Skin weeping 493.91 25.01 149 153706 898 79589635
Eyelids pruritus 490.22 25.01 145 153710 808 79589725
Drug effect less than expected 481.91 25.01 173 153682 1911 79588622
Nausea 480.86 25.01 691 153164 956505 78634028
Extra dose administered 480.31 25.01 261 153594 8154 79582379
Rebound eczema 477.46 25.01 92 153763 6 79590527
Injection site irritation 475.82 25.01 202 153653 3588 79586945
Eyelid margin crusting 470.87 25.01 144 153711 915 79589618
Thrombocytopenia 463.25 25.01 10 153845 265249 79325284
Erythema of eyelid 460.84 25.01 177 153678 2393 79588140
Neutropenia 444.37 25.01 28 153827 287682 79302851
Rebound atopic dermatitis 433.56 25.01 88 153767 34 79590499
Eye disorder 428.58 25.01 358 153497 23054 79567479
Febrile neutropenia 428.31 25.01 3 153852 230996 79359537
Periorbital swelling 423.12 25.01 172 153683 2724 79587809
Completed suicide 422.47 25.01 11 153844 245756 79344777
Drug intolerance 406.98 25.01 26 153829 264093 79326440
Scratch 397.41 25.01 230 153625 8133 79582400
Swelling of eyelid 396.68 25.01 178 153677 3633 79586900
Dermatitis 394.38 25.01 328 153527 20993 79569540
Infusion related reaction 389.48 25.01 12 153843 230225 79360308
Injection site dryness 389.24 25.01 99 153756 274 79590259
Confusional state 383.96 25.01 74 153781 317923 79272610
Skin irritation 375.73 25.01 247 153608 10993 79579540
Haemoglobin decreased 367.21 25.01 14 153841 222105 79368428
Asthenia 358.57 25.01 278 153577 511411 79079122
General physical health deterioration 352.06 25.01 55 153800 275183 79315350
Abdominal pain 348.34 25.01 158 153697 389411 79201122
Sepsis 337.53 25.01 57 153798 269371 79321162
Pneumonia 336.34 25.01 471 153384 659775 78930758
Eye inflammation 330.58 25.01 186 153669 6227 79584306
Off label use of device 327.28 25.01 87 153768 302 79590231
Hyponatraemia 321.70 25.01 4 153851 177844 79412689
Platelet count decreased 319.28 25.01 13 153842 194651 79395882
Visual impairment 316.83 25.01 607 153248 91524 79499009
Wrong technique in device usage process 304.83 25.01 151 153704 3877 79586656
Pancytopenia 298.58 25.01 4 153851 165741 79424792
Drug abuse 297.25 25.01 3 153852 162688 79427845
Overdose 293.30 25.01 15 153840 184191 79406342
Decreased appetite 292.09 25.01 148 153707 342270 79248263
White blood cell count decreased 288.60 25.01 19 153836 188269 79402264
Renal failure 283.96 25.01 29 153826 200939 79389594
Hospitalisation 278.65 25.01 583 153272 93653 79496880
Dehydration 274.78 25.01 70 153785 248117 79342416
Alanine aminotransferase increased 269.50 25.01 10 153845 162560 79427973
Respiratory failure 266.58 25.01 22 153833 180889 79409644
Eyelid skin dryness 264.56 25.01 65 153790 148 79590385
Hepatic enzyme increased 261.53 25.01 25 153830 182585 79407948
Lack of injection site rotation 258.28 25.01 78 153777 472 79590061
Injection site exfoliation 257.84 25.01 68 153787 227 79590306
Cardiac arrest 256.16 25.01 20 153835 172076 79418457
Synovitis 254.33 25.01 8 153847 150726 79439807
Hypokalaemia 253.06 25.01 5 153850 144035 79446498
Constipation 252.55 25.01 115 153740 282935 79307598
Blood creatinine increased 248.84 25.01 12 153843 155045 79435488
Oedema peripheral 245.35 25.01 90 153765 252198 79338335
Injection site discomfort 245.25 25.01 142 153713 5024 79585509
Contraindicated product administered 244.09 25.01 15 153840 157523 79433010
Hordeolum 241.11 25.01 120 153735 3113 79587420
Hypertension 240.37 25.01 173 153682 330819 79259714
Rheumatoid arthritis 240.18 25.01 54 153801 208416 79382117
Fall 239.96 25.01 356 153499 487273 79103260
Eyelid irritation 232.14 25.01 69 153786 392 79590141
Fear of injection 229.96 25.01 156 153699 7318 79583215
Unevaluable event 227.51 25.01 395 153460 55190 79535343
Surgery 227.45 25.01 298 153557 32468 79558065
Eyelid rash 226.41 25.01 55 153800 117 79590416
Ocular discomfort 226.07 25.01 133 153722 4850 79585683
Aspartate aminotransferase increased 224.84 25.01 10 153845 138631 79451902
Disease progression 222.16 25.01 43 153812 184319 79406214
Bradycardia 219.10 25.01 10 153845 135547 79454986
Gastrointestinal haemorrhage 217.52 25.01 18 153837 147701 79442832
Renal impairment 217.19 25.01 25 153830 157758 79432775
Injection site discolouration 215.60 25.01 151 153704 7463 79583070
Tachycardia 213.07 25.01 42 153813 177726 79412807
Multiple organ dysfunction syndrome 207.98 25.01 5 153850 120241 79470292
Treatment failure 204.92 25.01 40 153815 170446 79420087
Injection site vesicles 202.78 25.01 105 153750 2967 79587566
Blood pressure increased 201.13 25.01 78 153777 211282 79379251
Needle issue 201.07 25.01 181 153674 12887 79577646
Pleural effusion 199.97 25.01 23 153832 145239 79445294
Septic shock 198.66 25.01 9 153846 122792 79467741
Pulmonary embolism 198.64 25.01 44 153811 171610 79418923
Leukopenia 197.21 25.01 6 153849 116507 79474026
Injection site haemorrhage 195.82 25.01 255 153600 27615 79562918
Rash pruritic 195.43 25.01 429 153426 71200 79519333
Urticaria 191.55 25.01 786 153069 184415 79406118
Hyperkalaemia 189.71 25.01 7 153848 114391 79476142
Cardiac failure 188.92 25.01 35 153820 154807 79435726
Intentional overdose 188.90 25.01 3 153852 105957 79484576
Skin discolouration 187.05 25.01 306 153549 40728 79549805
Burning sensation 186.57 25.01 374 153481 58258 79532275
Interstitial lung disease 179.73 25.01 9 153846 112591 79477942
Intentional product use issue 178.01 25.01 38 153817 152074 79438459
Weight decreased 176.84 25.01 257 153598 354941 79235592
Seizure 174.25 25.01 73 153782 188761 79401772
C-reactive protein increased 171.33 25.01 23 153832 129004 79461529
Eye infection 169.55 25.01 158 153697 11762 79578771
Atrial fibrillation 169.39 25.01 85 153770 197801 79392732
Hypoglycaemia 169.21 25.01 6 153849 101588 79488945
Neutrophil count decreased 166.08 25.01 3 153852 93956 79496577
Cardiac failure congestive 163.75 25.01 37 153818 142365 79448168
Depressed level of consciousness 163.49 25.01 5 153850 96647 79493886
Periorbital irritation 162.83 25.01 31 153824 0 79590533
Coma 160.79 25.01 8 153847 100641 79489892
Lower respiratory tract infection 160.25 25.01 28 153827 129192 79461341
Arthropathy 157.82 25.01 72 153783 177039 79413494
Somnolence 155.74 25.01 139 153716 238842 79351691
Rhabdomyolysis 150.62 25.01 13 153842 103118 79487415
Eosinophilic granulomatosis with polyangiitis 148.70 25.01 91 153764 3569 79586964
Deep vein thrombosis 148.21 25.01 27 153828 120892 79469641
Pain of skin 147.76 25.01 161 153694 14452 79576081
Injection site warmth 147.75 25.01 162 153693 14645 79575888
Eyelid exfoliation 147.14 25.01 38 153817 114 79590419
Skin discomfort 146.04 25.01 55 153800 702 79589831
Pyrexia 145.34 25.01 745 153110 677964 78912569
Unintentional use for unapproved indication 143.63 25.01 41 153814 197 79590336
Device defective 142.39 25.01 71 153784 1849 79588684
Pericarditis 139.78 25.01 18 153837 104218 79486315
Systemic lupus erythematosus 138.24 25.01 32 153823 121117 79469416
Sensitive skin 138.22 25.01 68 153787 1719 79588814
Hypoxia 138.03 25.01 18 153837 103225 79487308
Agitation 136.70 25.01 16 153839 99699 79490834
Glossodynia 135.82 25.01 19 153836 103318 79487215
Skin disorder 134.70 25.01 238 153617 33705 79556828
General physical condition abnormal 131.92 25.01 106 153749 6457 79584076
Ascites 131.20 25.01 3 153852 75559 79514974
Acne 131.06 25.01 208 153647 26982 79563551
Eosinophil count increased 128.80 25.01 162 153693 16943 79573590
Suicide attempt 128.11 25.01 8 153847 82924 79507609
Hepatic function abnormal 126.56 25.01 3 153852 73104 79517429
Fatigue 125.52 25.01 1169 152686 928558 78661975
Eczema eyelids 124.75 25.01 35 153820 156 79590377
Oxygen saturation decreased 118.84 25.01 50 153805 128997 79461536
Syncope 118.54 25.01 103 153752 179346 79411187
Urinary tract infection 118.43 25.01 218 153637 274294 79316239
Drug hypersensitivity 117.26 25.01 251 153604 298665 79291868
Tremor 116.81 25.01 94 153761 169989 79420544
Eye allergy 115.90 25.01 46 153809 682 79589851
Cough 115.71 25.01 1148 152707 365641 79224892
Malaise 115.02 25.01 520 153335 489349 79101184
Rash papular 114.49 25.01 174 153681 21742 79568791
Blood creatine phosphokinase increased 113.31 25.01 3 153852 66087 79524446
Asthma 109.89 25.01 534 153321 134561 79455972
Stomatitis 108.65 25.01 75 153780 146682 79443851
Therapy non-responder 108.09 25.01 23 153832 92282 79498251
Pneumonia aspiration 107.99 25.01 5 153850 66962 79523571
Incorrect dose administered by device 107.62 25.01 84 153771 4905 79585628
Hallucination 107.58 25.01 18 153837 85727 79504806
Myocardial infarction 107.38 25.01 118 153737 184011 79406522
Musculoskeletal pain 107.33 25.01 32 153823 102322 79488211
Acute myocardial infarction 106.49 25.01 12 153843 77024 79513509
Oedema 105.90 25.01 49 153806 119531 79471002
Mobility decreased 105.24 25.01 52 153803 122123 79468410
Blood pressure fluctuation 105.16 25.01 6 153849 67139 79523394
Hyperglycaemia 105.11 25.01 8 153847 70327 79520206
Medication error 104.90 25.01 7 153848 68635 79521898
Blood pressure systolic increased 104.87 25.01 6 153849 66980 79523553
Oropharyngeal pain 103.56 25.01 452 153403 108901 79481632
Rectal haemorrhage 102.72 25.01 13 153842 76287 79514246
Therapeutic response unexpected 102.28 25.01 157 153698 19789 79570744
Injection site eczema 102.03 25.01 25 153830 56 79590477
Foreign body sensation in eyes 101.62 25.01 59 153796 2098 79588435
Joint swelling 101.45 25.01 257 153598 288389 79302144
Helicobacter infection 101.20 25.01 9 153846 69695 79520838
Liver disorder 100.81 25.01 11 153844 72406 79518127
Hepatic failure 100.60 25.01 4 153851 61208 79529325
Conjunctivitis allergic 99.96 25.01 54 153801 1666 79588867
Haematuria 99.63 25.01 9 153846 68827 79521706
Coronary artery disease 99.12 25.01 7 153848 65467 79525066
Haematochezia 98.31 25.01 24 153831 87621 79502912
Blood cholesterol increased 97.75 25.01 21 153834 83699 79506834
Wound 97.74 25.01 51 153804 116128 79474405
Respiratory arrest 97.24 25.01 3 153852 57547 79532986
Melaena 96.74 25.01 5 153850 60885 79529648
Cognitive disorder 96.39 25.01 11 153844 69915 79520618
Drug ineffective for unapproved indication 96.24 25.01 266 153589 50972 79539561
Impaired healing 94.50 25.01 26 153829 87629 79502904
Unresponsive to stimuli 93.93 25.01 3 153852 55785 79534748
Quality of life decreased 93.70 25.01 108 153747 10312 79580221
Blood alkaline phosphatase increased 93.02 25.01 8 153847 63656 79526877
Injection site inflammation 92.46 25.01 70 153785 3906 79586627
Anosmia 92.15 25.01 99 153756 8745 79581788
Pulmonary oedema 91.79 25.01 28 153827 88226 79502307
Drug reaction with eosinophilia and systemic symptoms 91.39 25.01 9 153846 64235 79526298
Abdominal discomfort 90.63 25.01 220 153635 250507 79340026
Hepatitis 90.39 25.01 4 153851 55723 79534810
Chronic kidney disease 89.72 25.01 11 153844 66143 79524390
Jaundice 89.36 25.01 3 153852 53346 79537187
Middle insomnia 88.82 25.01 131 153724 15938 79574595
Gamma-glutamyltransferase increased 88.44 25.01 4 153851 54676 79535857
Heart rate decreased 87.68 25.01 15 153840 70301 79520232
Symptom recurrence 87.59 25.01 55 153800 2259 79588274
Eosinophilic pneumonia 86.56 25.01 76 153779 5234 79585299
Neuropathy peripheral 86.37 25.01 87 153768 141218 79449315
Scab 85.84 25.01 104 153751 10468 79580065
Plasma cell myeloma 85.80 25.01 4 153851 53255 79537278
Perioral dermatitis 85.65 25.01 31 153824 351 79590182
Suicidal ideation 85.43 25.01 21 153834 76319 79514214
Keratitis 85.16 25.01 69 153786 4253 79586280
Orthostatic hypotension 85.03 25.01 6 153849 56158 79534375
Intercepted product storage error 84.81 25.01 28 153827 235 79590298
Blood pressure decreased 84.66 25.01 43 153812 99423 79491110
Sneezing 84.62 25.01 143 153712 19540 79570993
Drug dose omission by device 83.45 25.01 80 153775 6170 79584363
Muscular weakness 83.15 25.01 113 153742 160616 79429917
Transaminases increased 82.99 25.01 4 153851 51739 79538794
Acute respiratory failure 82.99 25.01 9 153846 59532 79531001
Loss of consciousness 82.99 25.01 122 153733 167821 79422712
Pneumonitis 82.83 25.01 10 153845 60850 79529683
Cutaneous T-cell lymphoma 82.16 25.01 56 153799 2647 79587886
Red blood cell count decreased 81.96 25.01 8 153847 57505 79533028
Injury 81.66 25.01 24 153831 77472 79513061
Blood urea increased 80.82 25.01 3 153852 48787 79541746
Psoriatic arthropathy 80.66 25.01 25 153830 77974 79512559
Asthenopia 80.29 25.01 53 153802 2374 79588159
Osteoarthritis 78.51 25.01 35 153820 87274 79503259
Dizziness 77.35 25.01 647 153208 525794 79064739
Muscle injury 77.10 25.01 4 153851 48557 79541976
Chest pain 76.60 25.01 283 153572 282021 79308512
Respiratory distress 76.01 25.01 11 153844 58328 79532205
Blood glucose increased 75.90 25.01 66 153789 114909 79475624
Urinary retention 75.38 25.01 10 153845 56620 79533913
Cholestasis 74.91 25.01 7 153848 52102 79538431
Injury associated with device 73.40 25.01 58 153797 3448 79587085
Dysarthria 73.00 25.01 20 153835 67602 79522931
Haematemesis 72.59 25.01 8 153847 52256 79538277
Irritable bowel syndrome 71.87 25.01 16 153839 62225 79528308
Product administered at inappropriate site 69.19 25.01 59 153796 3906 79586627
Sunburn 68.86 25.01 58 153797 3775 79586758
Generalised tonic-clonic seizure 68.53 25.01 4 153851 43906 79546627
Periorbital pain 68.21 25.01 19 153836 82 79590451
Ventricular tachycardia 68.04 25.01 3 153852 41932 79548601
Hypothyroidism 67.98 25.01 10 153845 52382 79538151
Back pain 67.68 25.01 329 153526 303851 79286682
Gastrointestinal disorder 67.25 25.01 82 153773 122123 79468410
Disorientation 66.96 25.01 19 153836 62757 79527776
Colitis 66.52 25.01 29 153826 73278 79517255
Cerebral haemorrhage 66.24 25.01 15 153840 57658 79532875
Dysphagia 66.11 25.01 83 153772 122053 79468480
Drug dependence 65.88 25.01 3 153852 40766 79549767
Acute respiratory distress syndrome 65.87 25.01 5 153850 44062 79546471
Hypophagia 65.47 25.01 6 153849 45361 79545172
Musculoskeletal stiffness 65.25 25.01 151 153704 174857 79415676
Multiple sclerosis relapse 64.94 25.01 7 153848 46526 79544007
Ocular surface disease 64.51 25.01 19 153836 104 79590429
Dyskinesia 64.40 25.01 6 153849 44767 79545766
Psychotic disorder 63.92 25.01 4 153851 41398 79549135
Upper gastrointestinal haemorrhage 63.88 25.01 4 153851 41376 79549157
Periorbital inflammation 63.84 25.01 18 153837 82 79590451
Hypervolaemia 63.38 25.01 5 153850 42685 79547848
Blood lactate dehydrogenase increased 62.91 25.01 3 153852 39167 79551366
Altered state of consciousness 62.70 25.01 6 153849 43816 79546717
Angina pectoris 62.41 25.01 12 153843 51720 79538813
Depression 62.34 25.01 212 153643 216578 79373955
Shock 62.20 25.01 6 153849 43542 79546991
Cholelithiasis 61.90 25.01 13 153842 52651 79537882
Type 2 diabetes mellitus 61.46 25.01 17 153838 57105 79533428
Red blood cell sedimentation rate increased 61.42 25.01 8 153847 45934 79544599
Aggression 61.10 25.01 12 153843 50946 79539587
Arrhythmia 60.96 25.01 21 153834 61251 79529282
Rhinorrhoea 60.60 25.01 299 153556 75775 79514758
Pulmonary hypertension 60.51 25.01 10 153845 48070 79542463
Pigmentation disorder 60.50 25.01 64 153791 5554 79584979
Eyelid thickening 60.31 25.01 16 153839 55 79590478
Sinus operation 59.92 25.01 45 153810 2480 79588053
Dyspnoea exertional 59.91 25.01 48 153807 87025 79503508
Dyspnoea 59.86 25.01 1231 152624 855794 78734739
Skin depigmentation 59.40 25.01 33 153822 1077 79589456
Heart rate increased 59.33 25.01 88 153767 120636 79469897
Fibromyalgia 59.10 25.01 25 153830 64315 79526218
Hyposmia 58.84 25.01 29 153826 736 79589797
Pancreatitis acute 58.81 25.01 12 153843 49592 79540941
Product temperature excursion issue 58.49 25.01 21 153834 232 79590301
Nasal polypectomy 58.34 25.01 13 153842 15 79590518
Palpitations 56.84 25.01 98 153757 126512 79464021
Folliculitis 56.82 25.01 18 153837 55362 79535171
Facial discomfort 56.27 25.01 17 153838 103 79590430
Pulmonary fibrosis 55.91 25.01 9 153846 44103 79546430
Pallor 55.57 25.01 14 153841 50048 79540485
Obesity 55.43 25.01 3 153852 35122 79555411
Drug effective for unapproved indication 55.31 25.01 63 153792 5938 79584595
Superficial injury of eye 55.24 25.01 19 153836 183 79590350
Gait disturbance 54.97 25.01 210 153645 207296 79383237
Sleep disorder due to general medical condition, insomnia type 54.95 25.01 9 153846 43547 79546986
Angioedema 54.76 25.01 40 153815 75995 79514538
Rash maculo-papular 54.46 25.01 20 153835 56058 79534475
Full blood count abnormal 54.22 25.01 7 153848 40467 79550066
Sinus tachycardia 52.94 25.01 5 153850 36903 79553630
Balance disorder 52.65 25.01 68 153787 98789 79491744
Skin texture abnormal 52.18 25.01 23 153832 449 79590084
Pancreatitis 52.14 25.01 34 153821 68541 79521992
Nasal congestion 52.09 25.01 288 153567 76264 79514269
Ejection fraction decreased 51.47 25.01 4 153851 34573 79555960
Knee operation 51.41 25.01 60 153795 5806 79584727
Coagulopathy 51.33 25.01 5 153850 36001 79554532
Hallucination, visual 51.02 25.01 3 153852 32726 79557807
Dyspepsia 50.76 25.01 82 153773 108605 79481928
Epilepsy 50.32 25.01 9 153846 40851 79549682
Hand dermatitis 49.92 25.01 21 153834 364 79590169
Osteoporosis 49.75 25.01 21 153834 54091 79536442
Photophobia 49.36 25.01 117 153738 20411 79570122
Abdominal distension 48.94 25.01 98 153757 119552 79470981
Subdural haematoma 48.64 25.01 3 153852 31431 79559102
Liver function test increased 48.46 25.01 9 153846 39764 79550769
Cerebral infarction 48.39 25.01 14 153841 45662 79544871
Bacteraemia 48.29 25.01 4 153851 32820 79557713
Dysuria 48.09 25.01 19 153836 50932 79539601
Anxiety 47.92 25.01 282 153573 248230 79342303
Skin mass 47.87 25.01 68 153787 7995 79582538
Stevens-Johnson syndrome 47.43 25.01 9 153846 39157 79551376
Clostridium difficile colitis 47.32 25.01 4 153851 32279 79558254
Tachypnoea 46.92 25.01 4 153851 32059 79558474
Keratoconus 46.73 25.01 15 153840 114 79590419
Myelodysplastic syndrome 46.56 25.01 3 153852 30298 79560235
Haemoptysis 46.47 25.01 25 153830 55974 79534559
Joint range of motion decreased 46.46 25.01 5 153850 33277 79557256
Blood pressure diastolic decreased 46.41 25.01 3 153852 30213 79560320
Injection site extravasation 45.26 25.01 73 153782 9596 79580937
Osteonecrosis 45.17 25.01 4 153851 31091 79559442
Pneumocystis jirovecii pneumonia 45.08 25.01 5 153850 32503 79558030
Aphasia 44.82 25.01 17 153838 46715 79543818
Electrolyte imbalance 44.79 25.01 4 153851 30877 79559656
Blood potassium increased 44.69 25.01 3 153852 29272 79561261
Device dispensing error 44.51 25.01 15 153840 135 79590398
Spinal operation 44.42 25.01 65 153790 7852 79582681
Miliaria 43.85 25.01 31 153824 1555 79588978
Gastrooesophageal reflux disease 43.83 25.01 84 153771 104162 79486371
Amnesia 43.08 25.01 35 153820 63022 79527511
Emotional distress 42.80 25.01 12 153843 39957 79550576
Upper-airway cough syndrome 42.58 25.01 79 153776 11614 79578919
Intentional self-injury 42.49 25.01 6 153849 32413 79558120
Lethargy 42.18 25.01 57 153798 81235 79509298
Clostridium difficile infection 41.82 25.01 15 153840 42670 79547863
Cellulitis 41.53 25.01 93 153762 108967 79481566
Blood potassium decreased 41.26 25.01 19 153836 46493 79544040
Hepatic steatosis 41.03 25.01 11 153844 37727 79552806
Small intestinal obstruction 41.03 25.01 3 153852 27269 79563264
Drainage 40.97 25.01 14 153841 132 79590401
Circulatory collapse 40.92 25.01 11 153844 37657 79552876
Pericardial effusion 40.84 25.01 19 153836 46218 79544315
Urinary incontinence 40.73 25.01 14 153841 40895 79549638
Femur fracture 40.66 25.01 12 153843 38640 79551893
Basal cell carcinoma 40.44 25.01 11 153844 37364 79553169
Pulmonary arterial hypertension 40.27 25.01 4 153851 28362 79562171
Metastases to liver 40.18 25.01 4 153851 28310 79562223
White blood cell count increased 40.09 25.01 51 153804 74582 79515951
Restlessness 39.70 25.01 20 153835 46472 79544061
Dandruff 39.51 25.01 18 153837 381 79590152
Throat clearing 39.33 25.01 36 153819 2618 79587915
Product administered to patient of inappropriate age 39.29 25.01 51 153804 5502 79585031
Adverse event 39.20 25.01 35 153820 60179 79530354
Dysgeusia 38.73 25.01 32 153823 57145 79533388
Product quality issue 38.63 25.01 9 153846 33931 79556602
Proteinuria 38.25 25.01 8 153847 32494 79558039
Skin erosion 38.18 25.01 45 153810 4400 79586133
Hepatic cytolysis 38.10 25.01 4 153851 27147 79563386
Cerebrovascular accident 38.06 25.01 162 153693 155130 79435403
Body temperature decreased 37.65 25.01 8 153847 32137 79558396
Chills 37.55 25.01 170 153685 160064 79430469
Frequent bowel movements 37.49 25.01 6 153849 29533 79561000
Injection site discharge 37.44 25.01 22 153833 800 79589733
Eczema herpeticum 37.28 25.01 16 153839 292 79590241
Injection site indentation 37.22 25.01 14 153841 178 79590355
Rosacea 37.11 25.01 43 153812 4129 79586404
Abnormal behaviour 37.07 25.01 12 153843 36409 79554124
Ataxia 36.98 25.01 3 153852 25036 79565497
Gastroenteritis 36.93 25.01 10 153845 34072 79556461
Haematoma 36.88 25.01 28 153827 52167 79538366
Osteomyelitis 36.85 25.01 9 153846 32856 79557677
Haemorrhoids 36.78 25.01 6 153849 29122 79561411
Diabetes mellitus 35.80 25.01 60 153795 78330 79512203
Maternal exposure during pregnancy 35.62 25.01 139 153716 136399 79454134
No adverse event 35.38 25.01 154 153701 37038 79553495
Swelling face 35.31 25.01 247 153608 70965 79519568
Body temperature increased 35.18 25.01 21 153834 44399 79546134
Neutrophil count increased 35.08 25.01 7 153848 29389 79561144
Full blood count decreased 35.07 25.01 5 153850 26814 79563719
Abdominal pain lower 35.06 25.01 9 153846 31773 79558760
Lymphopenia 34.99 25.01 8 153847 30549 79559984
Paranasal sinus discomfort 34.82 25.01 43 153812 4413 79586120
Lack of administration site rotation 34.60 25.01 9 153846 28 79590505
Cyanosis 34.60 25.01 4 153851 25178 79565355
Intestinal obstruction 34.55 25.01 20 153835 43000 79547533
Haemorrhage 34.45 25.01 78 153777 91040 79499493
Ear discomfort 33.81 25.01 60 153795 8523 79582010
Leukocytosis 33.78 25.01 21 153834 43434 79547099
Incorrect route of product administration 33.51 25.01 145 153710 34784 79555749
Treatment noncompliance 33.29 25.01 31 153824 52237 79538296
Fluid retention 33.22 25.01 52 153803 69757 79520776
Mental disorder 33.21 25.01 134 153721 31168 79559365
Lymphocytic infiltration 33.18 25.01 26 153829 1527 79589006
Molluscum contagiosum 33.10 25.01 17 153838 472 79590061
Iron deficiency anaemia 33.07 25.01 5 153850 25667 79564866
Diabetes mellitus inadequate control 32.98 25.01 4 153851 24260 79566273
Bursitis 32.80 25.01 14 153841 35830 79554703
Glomerular filtration rate decreased 32.76 25.01 3 153852 22699 79567834
Respiration abnormal 32.70 25.01 56 153799 7732 79582801
Hand-foot-and-mouth disease 32.69 25.01 15 153840 323 79590210
Accidental overdose 32.36 25.01 18 153837 39563 79550970
Sinus disorder 32.15 25.01 106 153749 22358 79568175
Injection site scar 32.03 25.01 20 153835 813 79589720
Cholecystitis 31.88 25.01 3 153852 22209 79568324
Eyelid pain 31.86 25.01 15 153840 343 79590190
Ischaemic stroke 31.86 25.01 12 153843 33119 79557414
Pharyngeal swelling 31.75 25.01 55 153800 7664 79582869
Therapy interrupted 31.54 25.01 132 153723 31209 79559324
Injection site hypoaesthesia 31.39 25.01 17 153838 527 79590006
Pustule 31.05 25.01 28 153827 1997 79588536
Chromaturia 31.00 25.01 6 153849 25740 79564793
Atrial flutter 30.83 25.01 3 153852 21622 79568911
Disease recurrence 30.74 25.01 24 153831 44085 79546448
Device operational issue 30.57 25.01 15 153840 377 79590156
Cystitis 30.49 25.01 34 153821 52698 79537835
Ill-defined disorder 30.47 25.01 50 153805 65825 79524708
Polyneuropathy 30.44 25.01 5 153850 24146 79566387
Rebound effect 30.40 25.01 52 153803 7174 79583359
Hypoalbuminaemia 30.24 25.01 3 153852 21294 79569239
Disturbance in attention 30.21 25.01 32 153823 50769 79539764
Urosepsis 30.21 25.01 7 153848 26488 79564045
Cardiomyopathy 30.15 25.01 9 153846 28765 79561768
Anaphylactic shock 29.97 25.01 16 153839 35980 79554553
Cardiomegaly 29.97 25.01 7 153848 26345 79564188
Blepharospasm 29.92 25.01 46 153809 5805 79584728
Sudden death 29.90 25.01 4 153851 22507 79568026
Hepatic cirrhosis 29.83 25.01 15 153840 34891 79555642
Oral candidiasis 29.74 25.01 10 153845 29618 79560915
Red blood cell sedimentation rate abnormal 29.65 25.01 3 153852 20960 79569573
Atopic keratoconjunctivitis 29.61 25.01 8 153847 30 79590503
Lung disorder 29.61 25.01 70 153785 80487 79510046
Emergency care 29.53 25.01 21 153834 1063 79589470
Pneumothorax 29.42 25.01 9 153846 28314 79562219
Eosinophilic pneumonia chronic 29.37 25.01 16 153839 502 79590031
Obstructive airways disorder 29.25 25.01 12 153843 31447 79559086
SARS-CoV-1 test positive 29.21 25.01 8 153847 32 79590501
Nightmare 29.15 25.01 7 153848 25854 79564679
Increased viscosity of upper respiratory secretion 29.08 25.01 14 153841 337 79590196
Dermatitis exfoliative generalised 29.01 25.01 51 153804 7190 79583343
Lip erythema 28.98 25.01 13 153842 265 79590268
Cutaneous T-cell lymphoma stage IV 28.82 25.01 8 153847 34 79590499
Injection site nodule 28.77 25.01 36 153819 3744 79586789
Muscle spasticity 28.09 25.01 4 153851 21471 79569062
Dystonia 27.95 25.01 4 153851 21395 79569138
Muscle rigidity 27.72 25.01 3 153852 19879 79570654
Herpes ophthalmic 27.48 25.01 23 153832 1484 79589049
Transient ischaemic attack 27.28 25.01 37 153818 52658 79537875
Chronic obstructive pulmonary disease 27.01 25.01 80 153775 85339 79505194
Gastric ulcer 26.89 25.01 16 153839 33889 79556644
Splenomegaly 26.83 25.01 4 153851 20750 79569783
Left ventricular dysfunction 26.79 25.01 3 153852 19358 79571175
Pharyngitis streptococcal 26.78 25.01 62 153793 10652 79579881
Hemiparesis 26.64 25.01 16 153839 33717 79556816
Night sweats 26.55 25.01 37 153818 52058 79538475
Heart rate irregular 26.52 25.01 15 153840 32664 79557869
Conjunctival papillae 26.26 25.01 5 153850 0 79590533
Foot deformity 26.21 25.01 7 153848 24067 79566466
Pyelonephritis 26.20 25.01 4 153851 20384 79570149
Cutaneous T-cell lymphoma stage III 26.18 25.01 7 153848 25 79590508
Asymptomatic COVID-19 26.02 25.01 13 153842 340 79590193
Hypereosinophilic syndrome 25.84 25.01 15 153840 533 79590000
Toothache 25.75 25.01 91 153764 19879 79570654
Thrombosis 25.71 25.01 80 153775 84020 79506513
Laboratory test abnormal 25.60 25.01 11 153844 28037 79562496
Platelet count increased 25.39 25.01 6 153849 22400 79568133
Withdrawal syndrome 25.37 25.01 10 153845 26844 79563689
Acute coronary syndrome 25.28 25.01 5 153850 21128 79569405
Intercepted product dispensing error 25.03 25.01 10 153845 151 79590382

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D11AH05 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Agents for dermatitis, excluding corticosteroids
FDA CS M0001357 Antibodies, Monoclonal
FDA MoA N0000193341 Interleukin 4 Receptor alpha Antagonists
FDA EPC N0000193342 Interleukin-4 Receptor alpha Antagonist

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

DiseaseRelationSNOMED_IDDOID
Atopic dermatitis indication 24079001 DOID:3310
Chronic sinusitis indication 40055000
Prurigo nodularis indication 63501000
Asthma indication 195967001 DOID:2841
Eosinophilic esophagitis indication 235599003 DOID:13922




šŸ¶ Veterinary Drug Use

None

šŸ¶ 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
Interleukin-4 receptor subunit alpha Membrane receptor ANTIBODY BINDING IC50 11.06 IUPHAR DRUG LABEL

External reference:

IDSource
420K487FSG UNII
4036554 VANDF
C3660996 UMLSCUI
CHEMBL2108675 ChEMBL_ID
DB12159 DRUGBANK_ID
D10354 KEGG_DRUG
9669 INN_ID
7574 IUPHAR_LIGAND_ID
255128 MMSL
32580 MMSL
d08549 MMSL
017152 NDDF
733487000 SNOMEDCT_US
763589007 SNOMEDCT_US
1876376 RXNORM
C582203 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5911 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5911 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5911 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5911 INJECTION, SOLUTION 100 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5914 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5914 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5914 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5914 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5915 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5915 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5915 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5915 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5916 INJECTION, SOLUTION 300 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5918 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5918 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5918 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5918 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5919 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5919 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5919 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Dupixent HUMAN PRESCRIPTION DRUG LABEL 1 0024-5919 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections