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

Stem definitionDrug idCAS RN
human origin 4934 1229022-83-6

Description:

MoleculeDescription

Synonyms:

  • secukinumab
  • cosentyx
  • AIN-457
  • AIN457
Secukinumab is a human IgG1 monoclonal antibody that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Secukinumab inhibits the release of proinflammatory cytokines and chemokines.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
10 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 2015 FDA NOVARTIS PHARMS CORP
Dec. 26, 2014 PMDA Novartis Pharma

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
Inappropriate schedule of product administration 1194.11 15.48 1029 94724 70802 50438569
Drug ineffective 1189.80 15.48 3806 91947 815527 49693844
Psoriasis 1137.86 15.48 984 94769 68016 50441355
Incorrect dose administered 967.53 15.48 772 94981 47642 50461729
Psoriatic arthropathy 830.59 15.48 698 95055 46334 50463037
Device malfunction 614.01 15.48 373 95380 14748 50494623
Device issue 408.25 15.48 323 95430 19649 50489722
Arthralgia 390.53 15.48 1751 94002 436951 50072420
Therapeutic product effect incomplete 385.47 15.48 651 95102 90864 50418507
Skin plaque 375.28 15.48 200 95553 6128 50503243
Accidental exposure to product 359.68 15.48 319 95434 22738 50486633
Musculoskeletal stiffness 356.51 15.48 765 94988 127716 50381655
Toxicity to various agents 348.74 15.48 12 95741 212487 50296884
Acute kidney injury 299.58 15.48 39 95714 228019 50281352
Pain 279.17 15.48 1959 93794 576944 49932427
Hypotension 266.03 15.48 60 95693 235409 50273962
Therapy interrupted 252.85 15.48 247 95506 19905 50489466
Drug interaction 248.50 15.48 40 95713 199581 50309790
COVID-19 246.00 15.48 368 95385 46294 50463077
Nasopharyngitis 240.69 15.48 857 94896 192070 50317301
Anaemia 236.58 15.48 91 95662 252365 50257006
Malaise 227.58 15.48 1241 94512 334291 50175080
Arthritis 221.78 15.48 500 95253 86221 50423150
Incorrect dose administered by device 220.72 15.48 115 95638 3360 50506011
Death 206.80 15.48 187 95566 325192 50184179
Therapeutic response shortened 203.56 15.48 143 95610 7246 50502125
Skin haemorrhage 202.58 15.48 139 95614 6779 50502592
Product storage error 202.39 15.48 175 95578 12049 50497322
Wrong technique in device usage process 198.28 15.48 96 95657 2390 50506981
Enthesopathy 195.36 15.48 138 95615 7055 50502316
Oropharyngeal pain 191.62 15.48 442 95311 77359 50432012
Injection site bruising 188.12 15.48 286 95467 36482 50472889
Neutropenia 187.84 15.48 28 95725 147937 50361434
Influenza 184.60 15.48 475 95278 89063 50420308
Macule 183.56 15.48 79 95674 1483 50507888
Inflammatory bowel disease 182.22 15.48 101 95652 3349 50506022
Skin exfoliation 178.43 15.48 266 95487 33346 50476025
Skin lesion 173.69 15.48 233 95520 26494 50482877
Pruritus 169.80 15.48 1015 94738 282553 50226818
Liver injury 156.24 15.48 213 95540 24593 50484778
Hyponatraemia 155.60 15.48 6 95747 96133 50413238
Seronegative arthritis 153.63 15.48 76 95677 1985 50507386
Pancytopenia 140.39 15.48 4 95749 84026 50425345
Skin fissures 139.27 15.48 122 95631 8546 50500825
Product dose omission issue 135.22 15.48 696 95057 183142 50326229
Pain in extremity 133.32 15.48 928 94825 271937 50237434
Inflammation 132.09 15.48 316 95437 56596 50452775
Ankylosing spondylitis 131.81 15.48 109 95644 7056 50502315
Thrombocytopenia 128.07 15.48 41 95712 127632 50381739
Rhinorrhoea 125.79 15.48 292 95461 51291 50458080
Constipation 123.55 15.48 102 95651 185606 50323765
Tonsillitis 123.49 15.48 90 95663 4833 50504538
Platelet count decreased 123.42 15.48 21 95732 100705 50408666
Needle issue 118.10 15.48 103 95650 7172 50502199
Decreased immune responsiveness 117.31 15.48 80 95673 3861 50505510
Uveitis 116.55 15.48 114 95639 9196 50500175
White blood cell count decreased 116.15 15.48 38 95715 116684 50392687
Hypokalaemia 115.51 15.48 15 95738 87977 50421394
Disease progression 115.25 15.48 21 95732 95845 50413526
Dactylitis 113.67 15.48 60 95693 1801 50507570
Somnolence 112.20 15.48 78 95675 154907 50354464
Cardiac arrest 110.44 15.48 14 95739 83637 50425734
Device defective 109.32 15.48 52 95701 1243 50508128
Tenosynovitis 108.00 15.48 116 95637 10449 50498922
Haemoglobin decreased 107.69 15.48 53 95700 127163 50382208
Respiratory failure 107.42 15.48 21 95732 91160 50418211
Injection site haemorrhage 104.88 15.48 163 95590 21183 50488188
Confusional state 104.10 15.48 119 95634 185809 50323562
Illness 102.38 15.48 174 95579 24366 50485005
Dislocation of vertebra 102.33 15.48 67 95686 3020 50506351
Treatment failure 101.75 15.48 522 95231 137115 50372256
Dehydration 101.04 15.48 84 95669 152365 50357006
Bradycardia 101.01 15.48 5 95748 64421 50444950
Vomiting 100.26 15.48 490 95263 460268 50049103
Therapy cessation 98.85 15.48 177 95576 25834 50483537
Renal failure 98.81 15.48 39 95714 106594 50402777
Dyspnoea 98.67 15.48 620 95133 546988 49962383
Product prescribing error 97.37 15.48 156 95597 20805 50488566
Overdose 94.86 15.48 35 95718 99692 50409679
Oral candidiasis 94.27 15.48 137 95616 16778 50492593
Ear infection 92.71 15.48 172 95581 25798 50483573
Mycotic allergy 88.35 15.48 39 95714 780 50508591
Peripheral swelling 87.06 15.48 677 95076 205259 50304112
Skin disorder 86.84 15.48 160 95593 23870 50485501
Drug abuse 86.81 15.48 7 95746 59839 50449532
Incorrect route of product administration 86.81 15.48 139 95614 18527 50490844
Tendonitis 85.49 15.48 130 95623 16575 50492796
Pharyngitis streptococcal 85.31 15.48 94 95659 8714 50500657
Concomitant disease aggravated 84.76 15.48 90 95663 8001 50501370
Tonsillar ulcer 82.56 15.48 28 95725 263 50509108
Cardiac failure 82.55 15.48 21 95732 76019 50433352
Cardio-respiratory arrest 81.95 15.48 5 95748 53887 50455484
Pleural effusion 81.94 15.48 26 95727 81428 50427943
Depressed level of consciousness 81.54 15.48 4 95749 51949 50457422
Syncope 81.16 15.48 47 95706 102955 50406416
Seizure 80.53 15.48 63 95690 117811 50391560
Gastrointestinal haemorrhage 80.07 15.48 20 95733 73301 50436070
Cardiac failure congestive 79.60 15.48 30 95723 84352 50425019
Oxygen saturation decreased 78.04 15.48 21 95732 73227 50436144
Tachycardia 77.93 15.48 46 95707 99717 50409654
Sinusitis 77.86 15.48 571 95182 169987 50339384
Fear of injection 76.89 15.48 75 95678 6028 50503343
Injection site pain 76.47 15.48 413 95340 110611 50398760
Stress 74.76 15.48 248 95505 53545 50455826
Joint swelling 74.50 15.48 750 95003 244536 50264835
Drug intolerance 74.44 15.48 686 95067 218418 50290953
Pustular psoriasis 74.14 15.48 61 95692 3920 50505451
Multiple organ dysfunction syndrome 72.70 15.48 6 95747 50331 50459040
Pulmonary embolism 72.50 15.48 52 95701 101652 50407719
C-reactive protein increased 70.78 15.48 281 95472 66193 50443178
Synovitis 69.85 15.48 437 95316 123428 50385943
Loss of consciousness 69.74 15.48 57 95696 104296 50405075
Coma 69.35 15.48 12 95741 56867 50452504
Red blood cell sedimentation rate increased 68.94 15.48 164 95589 29252 50480119
Hyperkalaemia 68.72 15.48 6 95747 48083 50461288
Off label use 68.46 15.48 572 95181 473854 50035517
Infection 67.29 15.48 558 95195 172396 50336975
Intentional overdose 66.43 15.48 18 95735 62486 50446885
Fall 66.08 15.48 368 95385 334564 50174807
Dry skin 65.33 15.48 205 95548 42986 50466385
Lower respiratory tract infection viral 63.17 15.48 29 95724 638 50508733
Gait inability 62.83 15.48 183 95570 36844 50472527
Limb discomfort 62.80 15.48 141 95612 24216 50485155
Hypoxia 61.86 15.48 11 95742 51112 50458259
Oedema peripheral 61.65 15.48 129 95624 157832 50351539
Drug tolerance decreased 61.25 15.48 81 95672 9079 50500292
Device leakage 60.89 15.48 65 95688 5813 50503558
Red blood cell sedimentation rate 60.69 15.48 52 95701 3534 50505837
Therapeutic product effect decreased 60.08 15.48 452 95301 135598 50373773
Multiple sclerosis relapse 59.69 15.48 6 95747 42958 50466413
Tremor 59.56 15.48 78 95675 114825 50394546
Agitation 59.38 15.48 14 95739 53370 50456001
Sepsis 58.48 15.48 101 95652 132824 50376547
Metabolic acidosis 57.85 15.48 4 95749 38821 50470550
Therapy non-responder 57.00 15.48 219 95534 50803 50458568
Cutaneous T-cell lymphoma 56.01 15.48 33 95720 1231 50508140
Alanine aminotransferase abnormal 56 15.48 53 95700 4103 50505268
Atrial fibrillation 55.95 15.48 66 95687 101679 50407692
Balance disorder 55.90 15.48 32 95721 70558 50438813
Hypoglycaemia 55.88 15.48 16 95737 53565 50455806
Product distribution issue 55.22 15.48 27 95726 687 50508684
Nail psoriasis 54.55 15.48 22 95731 348 50509023
Genital candidiasis 53.97 15.48 16 95737 92 50509279
Product dispensing error 53.95 15.48 75 95678 8816 50500555
Spinal pain 53.77 15.48 83 95670 10720 50498651
Hypermobility syndrome 53.72 15.48 27 95726 730 50508641
Fungal infection 51.71 15.48 149 95604 29816 50479555
Interstitial lung disease 51.68 15.48 18 95735 53158 50456213
Pain of skin 51.18 15.48 69 95684 7878 50501493
Colitis ulcerative 50.85 15.48 104 95649 16750 50492621
Cognitive disorder 50.22 15.48 11 95742 44112 50465259
Movement disorder 49.93 15.48 106 95647 17526 50491845
Neuropathy peripheral 49.81 15.48 66 95687 96691 50412680
C-reactive protein abnormal 49.66 15.48 140 95613 27669 50481702
Upper respiratory tract infection 49.38 15.48 251 95502 65647 50443724
Pulmonary oedema 48.54 15.48 16 95737 48922 50460449
Scab 48.53 15.48 61 95692 6501 50502870
Mental status changes 48.03 15.48 6 95747 36266 50473105
Sinus congestion 47.95 15.48 91 95662 13880 50495491
Epistaxis 47.84 15.48 31 95722 63923 50445448
Fibromyalgia 47.76 15.48 190 95563 44788 50464583
Spondyloarthropathy 47.46 15.48 25 95728 747 50508624
Secretion discharge 47.02 15.48 74 95679 9717 50499654
Joint stiffness 46.89 15.48 145 95608 30163 50479208
Asthenia 46.67 15.48 383 95370 318659 50190712
Osteonecrosis of jaw 46.63 15.48 4 95749 32522 50476849
Hyperglycaemia 45.90 15.48 7 95746 36398 50472973
Medication error 45.39 15.48 7 95746 36097 50473274
Septic shock 45.15 15.48 26 95727 57149 50452222
Pustule 45.09 15.48 28 95725 1150 50508221
Skin burning sensation 44.85 15.48 74 95679 10111 50499260
Respiratory tract congestion 43.29 15.48 88 95665 14111 50495260
Fluid retention 42.99 15.48 21 95732 50628 50458743
Rash pustular 42.85 15.48 57 95696 6424 50502947
Axial spondyloarthritis 42.80 15.48 16 95737 204 50509167
Device delivery system issue 42.71 15.48 20 95733 461 50508910
Respiratory arrest 42.19 15.48 4 95749 30005 50479366
Urticaria 42.10 15.48 402 95351 129159 50380212
Spondylitis 41.88 15.48 38 95715 2787 50506584
Hepatic function abnormal 41.86 15.48 6 95747 32675 50476696
Retinitis 41.75 15.48 32 95721 1855 50507516
Wound infection 41.53 15.48 79 95674 12069 50497302
Vulvovaginal candidiasis 41.47 15.48 37 95716 2655 50506716
Scratch 41.36 15.48 49 95704 4913 50504458
Guttate psoriasis 41.33 15.48 18 95735 348 50509023
Bone marrow failure 40.71 15.48 3 95750 27621 50481750
Unresponsive to stimuli 40.68 15.48 5 95748 30604 50478767
Nasal congestion 40.62 15.48 198 95555 50922 50458449
SARS-CoV-2 test positive 40.48 15.48 47 95706 4612 50504759
Foetal exposure during pregnancy 40.24 15.48 3 95750 27356 50482015
Mucosal inflammation 40.03 15.48 13 95740 40129 50469242
Candida infection 39.65 15.48 116 95637 23407 50485964
Dyspnoea exertional 39.46 15.48 24 95729 51209 50458162
Neck pain 39.06 15.48 212 95541 56855 50452516
Blood bilirubin increased 38.53 15.48 7 95746 32031 50477340
Laryngitis 38.39 15.48 72 95681 10884 50498487
Liver function test abnormal 38.21 15.48 18 95735 44321 50465050
Tongue disorder 37.97 15.48 65 95688 9151 50500220
Plasma cell myeloma 37.33 15.48 7 95746 31315 50478056
Sneezing 36.99 15.48 82 95671 13962 50495409
Cellulitis 36.93 15.48 245 95508 70553 50438818
Erythema 36.64 15.48 431 95322 145983 50363388
Anosmia 36.43 15.48 41 95712 3890 50505481
Cystitis 36.41 15.48 174 95579 44390 50464981
Adjustment disorder with depressed mood 36.24 15.48 35 95718 2779 50506592
Suicide attempt 36.14 15.48 27 95726 51705 50457666
Red blood cell count decreased 35.47 15.48 10 95743 33825 50475546
Lower respiratory tract infection 35.31 15.48 304 95449 94897 50414474
Insurance issue 35.30 15.48 33 95720 2515 50506856
Symptom recurrence 35.25 15.48 20 95733 694 50508677
Acute respiratory failure 35.24 15.48 6 95747 28776 50480595
Exposure via partner 35.17 15.48 12 95741 115 50509256
Panniculitis 35.07 15.48 60 95693 8443 50500928
Pulmonary hypertension 34.80 15.48 10 95743 33407 50475964
Eczema 34.55 15.48 108 95645 22594 50486777
Blood parathyroid hormone decreased 34.49 15.48 54 95699 7060 50502311
Heart rate decreased 34.37 15.48 13 95740 36484 50472887
Lip ulceration 34.33 15.48 28 95725 1777 50507594
Spinal fusion surgery 34.21 15.48 40 95713 3955 50505416
Psoriasis area severity index increased 34.11 15.48 10 95743 55 50509316
Skin swelling 33.99 15.48 30 95723 2122 50507249
Dyskinesia 33.69 15.48 6 95747 27855 50481516
Gastrointestinal pain 33.43 15.48 57 95696 7999 50501372
Grip strength decreased 33.32 15.48 72 95681 12049 50497322
Lymphocyte count decreased 33.30 15.48 5 95748 26302 50483069
Erysipelas 33.21 15.48 51 95702 6557 50502814
Arthropathy 33.19 15.48 450 95303 157456 50351915
Dizziness 33.11 15.48 459 95294 345910 50163461
Deep vein thrombosis 32.86 15.48 55 95698 73249 50436122
Pallor 32.86 15.48 3 95750 23196 50486175
Tooth abscess 32.65 15.48 74 95679 12786 50496585
Orthostatic hypotension 32.26 15.48 8 95745 29473 50479898
Cough 32.24 15.48 638 95115 240626 50268745
Kidney infection 32.13 15.48 93 95660 18653 50490718
Blood pressure decreased 32.10 15.48 35 95718 55874 50453497
Presyncope 32.05 15.48 4 95749 24194 50485177
Melaena 32.02 15.48 6 95747 26858 50482513
Thrombosis 32.01 15.48 35 95718 55798 50453573
Hepatitis 31.69 15.48 10 95743 31443 50477928
Infected dermal cyst 31.65 15.48 16 95737 438 50508933
Type 2 diabetes mellitus 31.63 15.48 139 95614 34236 50475135
Mobility decreased 31.61 15.48 259 95494 79689 50429682
Bursitis 31.59 15.48 103 95650 22032 50487339
Chronic kidney disease 31.52 15.48 18 95735 39753 50469618
Hypophagia 31.38 15.48 7 95746 27721 50481650
Gait disturbance 31.33 15.48 427 95326 149578 50359793
Decreased appetite 31.28 15.48 237 95516 200686 50308685
Burning sensation 31.21 15.48 169 95584 45277 50464094
Sacroiliitis 31.02 15.48 31 95722 2566 50506805
Urinary retention 30.90 15.48 6 95747 26184 50483187
Exposure during pregnancy 30.86 15.48 121 95632 120894 50388477
Nausea 30.84 15.48 1060 94693 704338 49805033
Hypersensitivity 30.79 15.48 575 95178 214586 50294785
Bone erosion 30.51 15.48 68 95685 11619 50497752
Haematocrit decreased 30.45 15.48 14 95739 34962 50474409
Bronchitis 30.35 15.48 316 95437 103843 50405528
Blood potassium decreased 30.33 15.48 16 95737 36929 50472442
Mouth ulceration 30.24 15.48 119 95634 27905 50481466
Urinary incontinence 30.20 15.48 8 95745 28200 50481171
Weight increased 30.10 15.48 241 95512 201650 50307721
Leukopenia 29.96 15.48 51 95702 67477 50441894
HLA-B*27 positive 29.92 15.48 12 95741 187 50509184
Respiratory tract infection 29.87 15.48 130 95623 31887 50477484
Muscle spasms 29.86 15.48 129 95624 125424 50383947
Rash maculo-papular 29.60 15.48 7 95746 26634 50482737
Rheumatoid arthritis 29.57 15.48 543 95210 202007 50307364
Device dispensing error 29.57 15.48 10 95743 93 50509278
Nail disorder 29.40 15.48 60 95693 9648 50499723
Blood sodium decreased 29.25 15.48 3 95750 21144 50488227
Pancreatitis acute 29.07 15.48 5 95748 23807 50485564
Prescribed overdose 28.55 15.48 76 95677 14524 50494847
Neurologic neglect syndrome 28.54 15.48 23 95730 1435 50507936
Hepatocellular injury 28.47 15.48 7 95746 25940 50483431
Sleep disorder due to general medical condition, insomnia type 28.30 15.48 12 95741 31435 50477936
Disorientation 28.21 15.48 16 95737 35468 50473903
Altered state of consciousness 28.11 15.48 4 95749 21906 50487465
Carotid artery thrombosis 27.98 15.48 23 95730 1476 50507895
Hypomagnesaemia 27.97 15.48 5 95748 23151 50486220
Tenderness 27.96 15.48 88 95665 18477 50490894
Abdominal discomfort 27.81 15.48 603 95150 231038 50278333
Pneumonia aspiration 27.63 15.48 12 95741 30992 50478379
Tendon pain 27.49 15.48 31 95722 2947 50506424
Nasal crusting 27.37 15.48 12 95741 236 50509135
Coronary artery disease 27.31 15.48 11 95742 29715 50479656
Rhesus antigen positive 27.00 15.48 10 95743 124 50509247
Premature delivery 26.72 15.48 6 95747 23657 50485714
Acute myocardial infarction 26.62 15.48 11 95742 29262 50480109
Blood urea increased 26.60 15.48 6 95747 23579 50485792
Joint injury 26.39 15.48 96 95657 21693 50487678
Full blood count abnormal 26.27 15.48 6 95747 23382 50485989
Bone lesion 26.12 15.48 40 95713 5130 50504241
Oral pain 25.97 15.48 105 95648 24928 50484443
Shock 25.96 15.48 4 95749 20646 50488725
Infusion related reaction 25.92 15.48 201 95552 169356 50340015
Product use issue 25.90 15.48 412 95341 149063 50360308
Psychotic disorder 25.73 15.48 5 95748 21807 50487564
Lupus-like syndrome 25.65 15.48 56 95697 9435 50499936
Stevens-Johnson syndrome 25.63 15.48 5 95748 21747 50487624
Urticarial vasculitis 25.35 15.48 15 95738 564 50508807
Diverticulitis 25.27 15.48 127 95626 33055 50476316
Hepatic enzyme abnormal 25.18 15.48 38 95715 4811 50504560
Hepatotoxicity 25.13 15.48 10 95743 27216 50482155
Dysstasia 24.61 15.48 82 95671 17737 50491634
Renal impairment 24.57 15.48 68 95685 75593 50433778
Acute respiratory distress syndrome 24.54 15.48 5 95748 21094 50488277
Discomfort 24.48 15.48 313 95440 108067 50401304
Skin reaction 24.45 15.48 62 95691 11506 50497865
Hyperadrenocorticism 24.27 15.48 12 95741 313 50509058
Atelectasis 24.24 15.48 3 95750 18267 50491104
Exostosis 24.16 15.48 62 95691 11591 50497780
Laboratory test abnormal 24.07 15.48 7 95746 23201 50486170
Urinary tract infection 24.02 15.48 574 95179 223446 50285925
Device related infection 23.94 15.48 5 95748 20730 50488641
Jaundice 23.92 15.48 10 95743 26419 50482952
Joint ankylosis 23.91 15.48 16 95737 748 50508623
Blister 23.87 15.48 257 95496 85161 50424210
Oral lichen planus 23.72 15.48 14 95739 524 50508847
Loose body in joint 23.59 15.48 19 95734 1184 50508187
Parakeratosis 23.39 15.48 11 95742 256 50509115
Cerebral infarction 23.37 15.48 6 95747 21598 50487773
Myocardial infarction 23.35 15.48 88 95665 88939 50420432
Blood alkaline phosphatase increased 23.24 15.48 22 95731 37504 50471867
Withdrawal syndrome 23.07 15.48 3 95750 17587 50491784
Osteonecrosis 22.97 15.48 7 95746 22510 50486861
Haematemesis 22.77 15.48 12 95741 27713 50481658
Diarrhoea haemorrhagic 22.73 15.48 47 95706 7628 50501743
Oropharyngeal candidiasis 22.71 15.48 17 95736 951 50508420
Near death experience 22.65 15.48 12 95741 363 50509008
Influenza like illness 22.63 15.48 186 95567 57273 50452098
Aphthous ulcer 22.61 15.48 57 95696 10540 50498831
Aggression 22.59 15.48 6 95747 21110 50488261
Genital cyst 22.57 15.48 7 95746 48 50509323
Lichen planus 22.50 15.48 23 95730 1956 50507415
Pneumonitis 22.48 15.48 14 95739 29496 50479875
Ascites 22.24 15.48 21 95732 35840 50473531
Blood pressure fluctuation 22.19 15.48 21 95732 35802 50473569
Meningitis streptococcal 22.17 15.48 9 95744 145 50509226
Pyoderma gangrenosum 22.03 15.48 27 95726 2804 50506567
Impetigo 21.98 15.48 18 95735 1149 50508222
Pharyngitis 21.95 15.48 78 95675 17425 50491946
Flushing 21.93 15.48 60 95693 66955 50442416
Blood calcium decreased 21.93 15.48 6 95747 20700 50488671
Back pain 21.86 15.48 558 95195 219472 50289899
Colitis microscopic 21.80 15.48 42 95711 6478 50502893
Cerebral haemorrhage 21.79 15.48 12 95741 27040 50482331
Feeling abnormal 21.77 15.48 346 95407 125146 50384225
Gastrooesophageal reflux disease 21.74 15.48 73 95680 76355 50433016
Dyspepsia 21.61 15.48 70 95683 74027 50435344
Injection site laceration 21.54 15.48 8 95745 100 50509271
Skin irritation 21.35 15.48 46 95707 7681 50501690
Product leakage 21.27 15.48 13 95740 519 50508852
Vulval cancer stage III 21.23 15.48 5 95748 9 50509362
Rebound psoriasis 21.00 15.48 7 95746 62 50509309
Transient ischaemic attack 21.00 15.48 18 95735 32192 50477179
Metastases to liver 20.96 15.48 6 95747 20098 50489273
Joint dislocation 20.96 15.48 61 95692 12272 50497099
Breast cancer 20.92 15.48 146 95607 42744 50466627
Disturbance in attention 20.86 15.48 17 95736 31169 50478202
Intestinal obstruction 20.82 15.48 12 95741 26371 50483000
Skin necrosis 20.68 15.48 56 95697 10811 50498560
Ear injury 20.57 15.48 9 95744 176 50509195
Eosinophilia 20.53 15.48 5 95748 18647 50490724
Oral lichenoid reaction 20.43 15.48 7 95746 68 50509303
Ulcer 20.38 15.48 84 95669 20116 50489255
Abscess sweat gland 20.26 15.48 5 95748 12 50509359
Swollen joint count increased 20.14 15.48 68 95685 14805 50494566
Blood lactate dehydrogenase increased 20.10 15.48 6 95747 19556 50489815
Ventricular tachycardia 20.04 15.48 3 95750 15818 50493553
Colitis 19.88 15.48 133 95620 38396 50470975
Femur fracture 19.84 15.48 25 95728 37439 50471932
Acute hepatic failure 19.79 15.48 3 95750 15674 50493697
Anxiety 19.67 15.48 228 95525 177378 50331993
Granuloma 19.67 15.48 34 95719 4824 50504547
Cardiogenic shock 19.66 15.48 3 95750 15596 50493775
Maternal exposure during pregnancy 19.49 15.48 417 95336 159361 50350010
Erythematotelangiectatic rosacea 19.46 15.48 5 95748 15 50509356
Chronic disease 19.42 15.48 7 95746 80 50509291
Ageusia 19.40 15.48 57 95696 11526 50497845
Coagulopathy 19.38 15.48 5 95748 17939 50491432
Muscle twitching 19.38 15.48 3 95750 15428 50493943
Manufacturing product shipping issue 19.34 15.48 7 95746 81 50509290
Otitis externa 19.33 15.48 19 95734 1541 50507830
Syringe issue 19.25 15.48 22 95731 2122 50507249
Drug-device interaction 19.18 15.48 7 95746 83 50509288
Cyanosis 18.96 15.48 3 95750 15181 50494190
Streptococcal infection 18.92 15.48 33 95720 4715 50504656
Myelodysplastic syndrome 18.87 15.48 3 95750 15129 50494242
Granuloma skin 18.87 15.48 37 95716 5781 50503590
Rheumatoid nodule 18.84 15.48 60 95693 12675 50496696
Transaminases increased 18.82 15.48 15 95738 27809 50481562
Arrhythmia 18.73 15.48 21 95732 33111 50476260
Tinea pedis 18.68 15.48 17 95736 1252 50508119
Adjustment disorder 18.61 15.48 21 95732 1998 50507373
Pharyngeal swelling 18.54 15.48 32 95721 4534 50504837
Abnormal behaviour 18.51 15.48 7 95746 19651 50489720
Papule 18.37 15.48 31 95722 4314 50505057
Papulopustular rosacea 18.16 15.48 5 95748 21 50509350
Laryngitis viral 18.16 15.48 5 95748 21 50509350
Electrolyte imbalance 18.13 15.48 5 95748 17164 50492207
Rhinitis 18.08 15.48 45 95708 8256 50501115
Pain in jaw 18.00 15.48 28 95725 38400 50470971
Body temperature decreased 18.00 15.48 70 95683 16325 50493046
Underdose 17.90 15.48 81 95672 20197 50489174
Hypothyroidism 17.84 15.48 23 95730 34102 50475269
Unevaluable event 17.63 15.48 38 95715 46028 50463343
Haematoma 17.62 15.48 19 95734 30491 50478880
Gamma-glutamyltransferase increased 17.61 15.48 18 95735 29605 50479766
Respiratory distress 17.60 15.48 19 95734 30470 50478901
Cardiomyopathy 17.50 15.48 4 95749 15582 50493789
Circulatory collapse 17.42 15.48 8 95745 19992 50489379
Blood test abnormal 17.36 15.48 54 95699 11265 50498106
Pancreatitis 17.28 15.48 34 95719 42580 50466791
Rash 16.95 15.48 1000 94753 436471 50072900
Gallbladder rupture 16.80 15.48 10 95743 380 50508991
Epilepsy 16.75 15.48 10 95743 21557 50487814
Iridocyclitis 16.69 15.48 20 95733 2029 50507342
Scarlet fever 16.63 15.48 7 95746 124 50509247
Hepatic failure 16.63 15.48 22 95731 32261 50477110
Dandruff 16.56 15.48 8 95745 198 50509173
Oesophageal candidiasis 16.49 15.48 32 95721 4962 50504409
Heart rate irregular 16.47 15.48 8 95745 19352 50490019
Seborrhoeic dermatitis 16.37 15.48 13 95740 794 50508577
Drug eruption 16.35 15.48 88 95665 23518 50485853
Angular cheilitis 16.21 15.48 10 95743 406 50508965
Palmoplantar pustulosis 16.14 15.48 10 95743 409 50508962
Ear infection fungal 16.04 15.48 7 95746 136 50509235
Hospitalisation 16.02 15.48 70 95683 67867 50441504
Metastases to bone 15.98 15.48 7 95746 17988 50491383
Collagen-vascular disease 15.95 15.48 6 95747 78 50509293
Chest pain 15.94 15.48 237 95516 176645 50332726
Ileus 15.67 15.48 3 95750 13226 50496145
Hangover 15.53 15.48 16 95737 1373 50507998
Diabetes mellitus inadequate control 15.53 15.48 3 95750 13142 50496229
Leukocytosis 15.49 15.48 12 95741 22567 50486804

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 1318.26 15.55 2232 46917 360938 29164440
Inappropriate schedule of product administration 1259.65 15.55 831 48318 43641 29481737
Psoriasis 1004.74 15.55 640 48509 31587 29493791
Incorrect dose administered 860.14 15.55 586 48563 32398 29492980
Device malfunction 750.09 15.55 338 48811 8169 29517209
Arthralgia 570.35 15.55 910 48239 138707 29386671
Psoriatic arthropathy 528.71 15.55 320 48829 14371 29511007
Therapeutic product effect incomplete 506.76 15.55 461 48688 38844 29486534
Pain 503.19 15.55 966 48183 170466 29354912
Skin plaque 411.29 15.55 174 48975 3588 29521790
Device issue 405.56 15.55 216 48933 7564 29517814
Accidental exposure to product 368.31 15.55 227 48922 10526 29514852
Pruritus 362.53 15.55 675 48474 116174 29409204
Arthritis 341.08 15.55 303 48846 24716 29500662
Musculoskeletal stiffness 336.70 15.55 361 48788 37097 29488281
Incorrect dose administered by device 329.17 15.55 116 49033 1423 29523955
Nasopharyngitis 308.52 15.55 435 48714 59230 29466148
Acute kidney injury 285.77 15.55 49 49100 265218 29260160
Toxicity to various agents 268.31 15.55 4 49145 173657 29351721
Product dose omission issue 230.53 15.55 500 48649 95883 29429495
Joint swelling 230.44 15.55 344 48805 49286 29476092
Skin exfoliation 226.17 15.55 231 48918 22414 29502964
Macule 203.71 15.55 73 49076 943 29524435
Drug interaction 192.48 15.55 46 49103 197339 29328039
Anaemia 176.97 15.55 57 49092 200894 29324484
Pain in extremity 174.71 15.55 489 48660 109944 29415434
Febrile neutropenia 171.48 15.55 3 49146 112237 29413141
Skin lesion 168.50 15.55 180 48969 18392 29506986
Hypotension 166.11 15.55 58 49091 194296 29331082
Uveitis 155.47 15.55 106 49043 5841 29519537
Decreased immune responsiveness 155.41 15.55 66 49083 1373 29524005
Inflammation 153.33 15.55 189 48960 22539 29502839
Product storage error 152.01 15.55 108 49041 6362 29519016
Therapeutic response shortened 146.09 15.55 94 49055 4697 29520681
Neck pain 144.12 15.55 178 48971 21269 29504109
Ankylosing spondylitis 142.53 15.55 88 49061 4088 29521290
Thrombocytopenia 142.46 15.55 26 49123 134797 29390581
Injection site haemorrhage 141.74 15.55 115 49034 8271 29517107
COVID-19 139.78 15.55 230 48919 35784 29489594
Therapeutic product effect decreased 137.82 15.55 205 48944 29246 29496132
Product prescribing error 133.54 15.55 157 48992 17819 29507559
Neutropenia 131.64 15.55 29 49120 131682 29393696
Erysipelas 131.56 15.55 84 49065 4141 29521237
Needle issue 128.46 15.55 86 49063 4597 29520781
Malaise 128.41 15.55 565 48584 159037 29366341
Completed suicide 121.73 15.55 7 49142 90239 29435139
Influenza 119.61 15.55 234 48915 41647 29483731
Wrong technique in device usage process 114.64 15.55 49 49100 1036 29524342
Inflammatory bowel disease 111.55 15.55 61 49088 2250 29523128
Spinal pain 111.51 15.55 80 49069 4784 29520594
Injection site pain 111.08 15.55 196 48953 32250 29493128
Oropharyngeal pain 105.59 15.55 181 48968 29104 29496274
Back pain 101.03 15.55 386 48763 101898 29423480
Cellulitis 99.46 15.55 229 48920 45611 29479767
Off label use 97.67 15.55 223 48926 300577 29224801
Vein rupture 96.03 15.55 38 49111 655 29524723
Respiratory failure 95.77 15.55 22 49127 97109 29428269
Confusional state 94.88 15.55 47 49102 127830 29397548
Peripheral swelling 93.58 15.55 275 48874 63464 29461914
Dactylitis 92.49 15.55 37 49112 657 29524721
Sinusitis 89.78 15.55 185 48964 34165 29491213
Decreased appetite 88.93 15.55 67 49082 145275 29380103
Erythema 87.92 15.55 301 48848 75305 29450073
Rhabdomyolysis 87.60 15.55 3 49146 60805 29464573
Therapy cessation 86.03 15.55 113 49036 14349 29511029
Pancytopenia 85.74 15.55 17 49132 83151 29442227
Death 84.77 15.55 289 48860 341795 29183583
Device defective 83.08 15.55 31 49118 452 29524926
Haemoglobin decreased 81.64 15.55 39 49110 108336 29417042
Platelet count decreased 81.44 15.55 36 49113 104636 29420742
Incorrect route of product administration 81.31 15.55 95 49054 10706 29514672
Seizure 80.78 15.55 27 49122 93096 29432282
Disease progression 79.86 15.55 19 49130 81897 29443481
Skin fissures 77.56 15.55 59 49090 3860 29521518
Scab 77.36 15.55 59 49090 3875 29521503
Overdose 76.86 15.55 19 49130 79800 29445578
Oral candidiasis 75.26 15.55 91 49058 10631 29514747
Colitis ulcerative 74.76 15.55 99 49050 12670 29512708
Lower respiratory tract infection 73.12 15.55 146 49003 26356 29499022
Sacroiliitis 72.30 15.55 36 49113 1091 29524287
Therapy interrupted 72.04 15.55 79 49070 8307 29517071
Hyponatraemia 71.46 15.55 13 49136 67620 29457758
Hyperkalaemia 71.26 15.55 9 49140 61383 29463995
Renal failure 70.83 15.55 56 49093 118543 29406835
Skin haemorrhage 70.32 15.55 54 49095 3583 29521795
Dry skin 69.90 15.55 133 49016 23174 29502204
Pain of skin 68.04 15.55 54 49095 3761 29521617
Scratch 67.62 15.55 47 49102 2671 29522707
Cardiac arrest 67.26 15.55 29 49120 85562 29439816
Venous injury 66.71 15.55 23 49126 263 29525115
Constipation 65.57 15.55 56 49093 114104 29411274
Cardio-respiratory arrest 65.04 15.55 5 49144 50596 29474782
Infection 64.82 15.55 276 48873 76475 29448903
Therapeutic product effect delayed 64.32 15.55 33 49116 1067 29524311
White blood cell count decreased 62.76 15.55 30 49119 83332 29442046
Dehydration 62.66 15.55 59 49090 114689 29410689
Bradycardia 62.45 15.55 16 49133 65613 29459765
Acne 61.07 15.55 76 49073 9144 29516234
Illness 61.06 15.55 65 49084 6609 29518769
Injection site bruising 60.97 15.55 69 49080 7511 29517867
Joint stiffness 59.43 15.55 76 49073 9397 29515981
Arthropathy 58.57 15.55 118 49031 21436 29503942
Product distribution issue 58.15 15.55 22 49127 334 29525044
Concomitant disease aggravated 57.49 15.55 55 49094 4923 29520455
Neutrophil count decreased 56.87 15.55 4 49145 43563 29481815
Gastrointestinal haemorrhage 54.89 15.55 32 49117 79501 29445877
Insurance issue 54.24 15.55 28 49121 917 29524461
Renal impairment 52.98 15.55 35 49114 81298 29444080
Pleural effusion 52.43 15.55 27 49122 71881 29453497
Hypokalaemia 52.27 15.55 10 49139 50193 29475185
Septic shock 51.07 15.55 20 49129 62540 29462838
Treatment failure 50.97 15.55 156 48993 36783 29488595
Rhinorrhoea 50.54 15.55 111 49038 21408 29503970
Metabolic acidosis 50.51 15.55 3 49146 37659 29487719
Epistaxis 50.36 15.55 12 49137 51692 29473686
Hypoxia 50.27 15.55 9 49140 47370 29478008
Multiple organ dysfunction syndrome 50.19 15.55 21 49128 63095 29462283
Swelling 49.61 15.55 150 48999 35133 29490245
Ear infection 49.27 15.55 64 49085 8036 29517342
Mobility decreased 48.58 15.55 122 49027 25658 29499720
Grip strength decreased 48.47 15.55 36 49113 2271 29523107
Muscle swelling 47.72 15.55 19 49130 333 29525045
Delirium 47.65 15.55 5 49144 39392 29485986
Symptom recurrence 47.12 15.55 18 49131 281 29525097
C-reactive protein increased 46.91 15.55 171 48978 44092 29481286
Discomfort 46.44 15.55 86 49063 14677 29510701
Injection site papule 46.43 15.55 18 49131 293 29525085
Rash 46.10 15.55 500 48649 189319 29336059
Movement disorder 46.06 15.55 70 49079 10167 29515211
Burning sensation 45.39 15.55 89 49060 15849 29509529
Intentional product use issue 45.24 15.55 8 49141 42490 29482888
Stress 45.08 15.55 106 49043 21384 29503994
Ligament calcification 44.83 15.55 16 49133 204 29525174
Skin disorder 44.76 15.55 74 49075 11544 29513834
Tachycardia 44.72 15.55 33 49116 72377 29453001
Oxygen saturation decreased 44.62 15.55 10 49139 44927 29480451
Enthesopathy 44.45 15.55 42 49107 3701 29521677
Cough 44.38 15.55 361 48788 126366 29399012
Sepsis 44.36 15.55 108 49041 142574 29382804
Mycobacterium tuberculosis complex test positive 43.68 15.55 25 49124 1008 29524370
Latent tuberculosis 43.11 15.55 25 49124 1034 29524344
Vomiting 43.01 15.55 194 48955 212066 29313312
Localised infection 42.85 15.55 80 49069 13736 29511642
Nephrolithiasis 42.71 15.55 115 49034 25219 29500159
Agitation 42.54 15.55 16 49133 51288 29474090
Blood creatine phosphokinase increased 42.51 15.55 8 49141 40636 29484742
Hallucination 42.33 15.55 11 49138 44701 29480677
Suicide attempt 42.11 15.55 4 49145 34106 29491272
Hypoglycaemia 41.93 15.55 14 49135 48332 29477046
Neuropathy peripheral 41.79 15.55 34 49115 70993 29454385
Aggression 41.75 15.55 5 49144 35536 29489842
Eczema 41.57 15.55 79 49070 13747 29511631
Musculoskeletal discomfort 41.56 15.55 52 49097 6289 29519089
Coma 40.77 15.55 8 49141 39442 29485936
Blood creatinine increased 40.58 15.55 49 49100 85053 29440325
Intentional product misuse 40.41 15.55 5 49144 34656 29490722
Electrocardiogram QT prolonged 40.26 15.55 6 49143 36131 29489247
Pharyngitis streptococcal 38.50 15.55 30 49119 2034 29523344
Mucosal inflammation 38.23 15.55 4 49145 31591 29493787
Cutaneous symptom 37.88 15.55 15 49134 259 29525119
Product dispensing error 37.62 15.55 46 49103 5434 29519944
Syncope 37.59 15.55 48 49101 81323 29444055
Ear infection fungal 37.52 15.55 9 49140 22 29525356
Sensitisation 37.36 15.55 13 49136 153 29525225
Skin infection 37.27 15.55 50 49099 6477 29518901
Product availability issue 36.94 15.55 23 49126 1084 29524294
Secretion discharge 36.75 15.55 40 49109 4170 29521208
Oedema peripheral 36.59 15.55 73 49076 103484 29421894
Fall 36.43 15.55 161 48988 177017 29348361
Mental status changes 36.26 15.55 7 49142 34920 29490458
Accident 35.66 15.55 37 49112 3651 29521727
Upper respiratory tract infection 35.41 15.55 113 49036 27236 29498142
Spondylitis 35.37 15.55 22 49127 1035 29524343
Atrial fibrillation 35.20 15.55 77 49072 105569 29419809
Abscess limb 34.49 15.55 34 49115 3157 29522221
Deep vein thrombosis 34.36 15.55 27 49122 57372 29468006
Pulmonary oedema 34.32 15.55 14 49135 42721 29482657
Lactic acidosis 33.75 15.55 5 49144 30242 29495136
Respiratory tract infection 33.70 15.55 78 49071 15573 29509805
Injection site swelling 33.65 15.55 58 49091 9359 29516019
Irritable bowel syndrome 33.40 15.55 32 49117 2869 29522509
Device dispensing error 33.25 15.55 9 49140 41 29525337
Nasal congestion 33.14 15.55 87 49062 18792 29506586
Drug reaction with eosinophilia and systemic symptoms 32.72 15.55 4 49145 27988 29497390
Dyspnoea 32.54 15.55 367 48782 326365 29199013
Tremor 32.31 15.55 45 49104 73493 29451885
Aspartate aminotransferase increased 32.23 15.55 31 49118 59694 29465684
Cutaneous lymphoma 32.07 15.55 10 49139 81 29525297
Pneumonia aspiration 31.23 15.55 11 49138 36726 29488652
Oral herpes 31.04 15.55 38 49111 4494 29520884
Loss of consciousness 30.89 15.55 47 49102 74009 29451369
Melaena 30.82 15.55 7 49142 31169 29494209
Asthenia 30.48 15.55 221 48928 215029 29310349
Pneumonitis 30.46 15.55 5 49144 28039 29497339
Palmoplantar pustulosis 30.20 15.55 10 49139 100 29525278
Respiratory distress 30.20 15.55 8 49141 32098 29493280
Eye infection 29.83 15.55 30 49119 2853 29522525
Pulmonary embolism 29.64 15.55 51 49098 76483 29448895
Hyperglycaemia 29.60 15.55 10 49139 34277 29491101
Rebound psoriasis 29.51 15.55 10 49139 108 29525270
Cerebral haemorrhage 29.24 15.55 8 49141 31418 29493960
Tonsillitis bacterial 29.21 15.55 7 49142 17 29525361
Oligoarthritis 29.07 15.55 9 49140 71 29525307
Underdose 28.75 15.55 62 49087 11807 29513571
Candida infection 28.62 15.55 72 49077 15153 29510225
Disability 28.60 15.55 36 49113 4380 29520998
Skin irritation 28.31 15.55 36 49113 4425 29520953
Hepatic function abnormal 28.22 15.55 15 49134 39244 29486134
Body surface area increased 28.12 15.55 9 49140 80 29525298
Device leakage 28.09 15.55 36 49113 4459 29520919
Cardiac failure 27.91 15.55 56 49093 79231 29446147
Exposure to communicable disease 27.84 15.55 10 49139 130 29525248
Angiocardiogram 27.83 15.55 11 49138 189 29525189
Dermatitis exfoliative generalised 27.74 15.55 29 49120 2887 29522491
Feeling abnormal 27.13 15.55 169 48980 54276 29471102
Wound 26.94 15.55 61 49088 12002 29513376
Tinea versicolour 26.94 15.55 12 49137 281 29525097
Limb discomfort 26.72 15.55 53 49096 9515 29515863
Drug intolerance 26.55 15.55 154 48995 48225 29477153
Intestinal haemorrhage 26.43 15.55 29 49120 3050 29522328
Gastrointestinal pain 26.29 15.55 27 49122 2632 29522746
Genital candidiasis 26.08 15.55 8 49141 61 29525317
Psoriasis area severity index increased 26.02 15.55 7 49142 31 29525347
Nail psoriasis 25.96 15.55 8 49141 62 29525316
Upper gastrointestinal haemorrhage 25.94 15.55 3 49146 21911 29503467
Musculoskeletal pain 25.87 15.55 106 49043 28847 29496531
Pustular psoriasis 25.84 15.55 21 49128 1513 29523865
Xyphoid retraction 25.78 15.55 10 49139 163 29525215
Somnolence 25.48 15.55 76 49073 93879 29431499
Influenza like illness 25.46 15.55 94 49055 24376 29501002
Seronegative arthritis 25.41 15.55 17 49132 907 29524471
Abnormal behaviour 25.40 15.55 4 49145 23123 29502255
Encephalopathy 25.20 15.55 10 49139 31033 29494345
Tooth infection 25.09 15.55 38 49111 5501 29519877
Tooth abscess 25.02 15.55 36 49113 4978 29520400
Lipoma 24.97 15.55 20 49129 1411 29523967
Coronavirus infection 24.87 15.55 29 49120 3259 29522119
Tonsillitis 24.87 15.55 23 49126 1972 29523406
Urinary retention 24.73 15.55 11 49138 31887 29493491
Orthostatic hypotension 24.65 15.55 4 49145 22625 29502753
Immune system disorder 24.54 15.55 33 49116 4284 29521094
Drug dependence 24.52 15.55 3 49146 20978 29504400
Body mass index abnormal 24.26 15.55 9 49140 129 29525249
Pelvic pain 24.06 15.55 23 49126 2056 29523322
Energy increased 23.90 15.55 18 49131 1160 29524218
Cholestasis 23.73 15.55 5 49144 23457 29501921
Bone marrow failure 23.70 15.55 8 49141 27441 29497937
Agranulocytosis 23.55 15.55 3 49146 20337 29505041
Cytomegalovirus infection 23.38 15.55 5 49144 23210 29502168
Disorientation 23.16 15.55 10 49139 29505 29495873
Malignant melanoma 22.88 15.55 42 49107 7119 29518259
Altered state of consciousness 22.86 15.55 3 49146 19886 29505492
Shock 22.84 15.55 4 49145 21400 29503978
Tinea pedis 22.84 15.55 17 49132 1076 29524302
Iridocyclitis 22.76 15.55 19 49130 1421 29523957
Bronchitis 22.65 15.55 121 49028 36747 29488631
Hepatocellular injury 22.60 15.55 4 49145 21239 29504139
Medication error 22.56 15.55 4 49145 21207 29504171
Headache 22.47 15.55 410 48739 173597 29351781
Conjunctivitis viral 22.31 15.55 7 49142 58 29525320
Skin discolouration 22.11 15.55 66 49083 15343 29510035
Pneumonia 22.09 15.55 387 48762 319785 29205593
Restlessness 21.83 15.55 5 49144 22140 29503238
Rash erythematous 21.74 15.55 82 49067 21480 29503898
Haematemesis 21.58 15.55 7 49142 24619 29500759
Oesophageal infection 21.21 15.55 10 49139 268 29525110
Folliculitis 20.94 15.55 29 49120 3871 29521507
Therapeutic response decreased 20.93 15.55 89 49060 24622 29500756
Pseudarthrosis 20.88 15.55 7 49142 73 29525305
Diarrhoea haemorrhagic 20.75 15.55 36 49113 5838 29519540
Product supply issue 20.64 15.55 11 49138 385 29524993
Blood pressure fluctuation 20.62 15.55 4 49145 19890 29505488
Onychomadesis 20.39 15.55 12 49137 510 29524868
Ear pruritus 20.36 15.55 10 49139 294 29525084
Hypersensitivity 20.29 15.55 154 48995 52749 29472629
Tuberculosis 20.26 15.55 40 49109 7156 29518222
Ocular hyperaemia 20.21 15.55 46 49103 9081 29516297
Blood bilirubin increased 20.21 15.55 16 49133 33877 29491501
Angioimmunoblastic T-cell lymphoma 20.11 15.55 10 49139 302 29525076
Hypokinesia 20.09 15.55 41 49108 7513 29517865
Dyshidrotic eczema 20.05 15.55 8 49141 141 29525237
Joint ankylosis 20.01 15.55 11 49138 410 29524968
Product leakage 19.96 15.55 11 49138 412 29524966
SARS-CoV-2 test positive 19.96 15.55 26 49123 3273 29522105
Total cholesterol/HDL ratio decreased 19.76 15.55 6 49143 44 29525334
Hepatic mass 19.73 15.55 15 49134 980 29524398
Generalised tonic-clonic seizure 19.52 15.55 4 49145 19135 29506243
Hypervolaemia 19.34 15.55 3 49146 17542 29507836
Cardiac failure congestive 19.31 15.55 64 49085 76517 29448861
Psychotic disorder 19.28 15.55 5 49144 20349 29505029
Drug resistance 19.09 15.55 6 49143 21534 29503844
Oral pustule 19.06 15.55 9 49140 242 29525136
Hidradenitis 18.95 15.55 13 49136 723 29524655
Premature baby 18.95 15.55 3 49146 17277 29508101
Bursitis 18.91 15.55 31 49118 4801 29520577
Pigmentation disorder 18.90 15.55 20 49129 2019 29523359
Drug hypersensitivity 18.78 15.55 55 49094 68351 29457027
Ventricular tachycardia 18.77 15.55 7 49142 22567 29502811
Hepatic failure 18.63 15.55 15 49134 31497 29493881
Self-consciousness 18.61 15.55 5 49144 22 29525356
Staphylococcal skin infection 18.60 15.55 13 49136 745 29524633
Pyoderma gangrenosum 18.53 15.55 15 49134 1074 29524304
Interstitial lung disease 18.45 15.55 43 49106 57675 29467703
Blood urea increased 18.42 15.55 12 49137 28100 29497278
Haematuria 18.41 15.55 28 49121 44111 29481267
Eye discharge 18.38 15.55 18 49131 1658 29523720
Dermatitis 18.05 15.55 40 49109 7758 29517620
Erythrodermic psoriasis 17.97 15.55 13 49136 787 29524591
Acute myeloid leukaemia 17.81 15.55 3 49146 16510 29508868
Skin burning sensation 17.79 15.55 26 49123 3647 29521731
Acute respiratory failure 17.67 15.55 11 49138 26391 29498987
Ascites 17.53 15.55 21 49128 36598 29488780
Terminal insomnia 17.50 15.55 10 49139 402 29524976
Injection site paraesthesia 17.46 15.55 7 49142 125 29525253
Blood alkaline phosphatase increased 17.45 15.55 13 49136 28393 29496985
Furuncle 17.40 15.55 23 49126 2936 29522442
Dyspnoea exertional 17.39 15.55 21 49128 36469 29488909
Feeling hot 17.39 15.55 61 49088 15427 29509951
Tubulointerstitial nephritis 17.36 15.55 4 49145 17639 29507739
Megacolon 17.16 15.55 17 49132 1588 29523790
Ear neoplasm 17.06 15.55 6 49143 73 29525305
Skin candida 17.06 15.55 10 49139 422 29524956
Inflammatory pain 17.01 15.55 7 49142 134 29525244
Axillary pain 16.86 15.55 9 49140 316 29525062
General physical health deterioration 16.84 15.55 101 49048 102756 29422622
Pulmonary hypertension 16.82 15.55 5 49144 18603 29506775
Granuloma annulare 16.78 15.55 7 49142 139 29525239
Diverticulitis 16.76 15.55 66 49083 17638 29507740
Alanine aminotransferase increased 16.74 15.55 61 49088 70883 29454495
Joint effusion 16.59 15.55 27 49122 4157 29521221
Wrong technique in product usage process 16.56 15.55 99 49050 31329 29494049
Joint injury 16.54 15.55 36 49113 6897 29518481
Hypophagia 16.49 15.55 7 49142 20865 29504513
Haematoma 16.49 15.55 9 49140 23203 29502175
Rash maculo-papular 16.42 15.55 10 49139 24279 29501099
Eye inflammation 16.37 15.55 17 49132 1679 29523699
Mechanical urticaria 16.37 15.55 6 49143 83 29525295
KL-6 increased 16.34 15.55 4 49145 11 29525367
Gait disturbance 16.28 15.55 190 48959 73159 29452219
Chronic kidney disease 16.27 15.55 22 49127 36394 29488984
Administration site haemorrhage 16.21 15.55 3 49146 0 29525378
Nasal abscess 16.21 15.55 3 49146 0 29525378
Atelectasis 16.16 15.55 3 49146 15389 29509989
Acute respiratory distress syndrome 16.13 15.55 9 49140 22926 29502452
Injection site reaction 16.13 15.55 48 49101 11140 29514238
Skin ulcer 16.06 15.55 68 49081 18772 29506606
Balance disorder 16.01 15.55 22 49127 36148 29489230
Borrelia infection 15.98 15.55 5 49144 41 29525337
Fungal pharyngitis 15.98 15.55 5 49144 41 29525337
Coronavirus test positive 15.86 15.55 9 49140 357 29525021
Paternal exposure during pregnancy 15.84 15.55 4 49145 13 29525365
Prostate cancer 15.82 15.55 84 49065 25443 29499935
Gastrointestinal fungal infection 15.80 15.55 6 49143 92 29525286
Tachypnoea 15.75 15.55 3 49146 15112 29510266
Haematocrit decreased 15.72 15.55 15 49134 29007 29496371
Coronary artery disease 15.72 15.55 31 49118 44159 29481219
Haemorrhage 15.71 15.55 32 49117 45040 29480338
Body temperature decreased 15.61 15.55 46 49103 10618 29514760
Nail dystrophy 15.60 15.55 7 49142 167 29525211

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
Inappropriate schedule of product administration 1570.84 13.82 1229 98059 91057 64308387
Psoriasis 1016.76 13.82 859 98429 70844 64328600
Drug ineffective 975.85 13.82 3162 96126 837085 63562359
Psoriatic arthropathy 800.01 13.82 606 98682 42675 64356769
Musculoskeletal stiffness 615.36 13.82 849 98439 122357 64277087
Arthralgia 591.66 13.82 1753 97535 440507 63958937
Acute kidney injury 507.06 13.82 52 99236 449188 63950256
Toxicity to various agents 502.99 13.82 12 99276 363501 64035943
Incorrect dose administered 501.26 13.82 540 98748 60225 64339219
Pain 470.04 13.82 1886 97402 551625 63847819
Skin plaque 451.55 13.82 237 99051 8703 64390741
Therapeutic product effect incomplete 427.37 13.82 652 98636 102830 64296614
Nasopharyngitis 410.23 13.82 921 98367 195152 64204292
Therapy interrupted 388.82 13.82 289 98999 19747 64379697
Arthritis 345.84 13.82 528 98760 83286 64316158
Drug interaction 345.44 13.82 69 99219 362014 64037430
Hypotension 329.02 13.82 90 99198 380884 64018560
Completed suicide 319.87 13.82 5 99283 224409 64175035
Pruritus 298.01 13.82 1106 98182 311294 64088150
COVID-19 293.93 13.82 428 98860 64712 64334732
Skin exfoliation 287.35 13.82 350 98938 44535 64354909
Anaemia 284.01 13.82 114 99174 378566 64020878
Pain in extremity 283.20 13.82 1066 98222 302019 64097425
Febrile neutropenia 272.59 13.82 3 99285 187654 64211790
Joint swelling 270.94 13.82 837 98451 214545 64184899
Malaise 270.59 13.82 1266 98022 394981 64004463
Influenza 268.25 13.82 540 98748 105991 64293453
Oropharyngeal pain 251.16 13.82 473 98815 88394 64311050
Neutropenia 249.66 13.82 36 99252 239588 64159856
Skin lesion 242.52 13.82 290 98998 36192 64363252
Inflammation 239.70 13.82 390 98898 64910 64334534
Device malfunction 236.78 13.82 205 99083 17428 64382016
Thrombocytopenia 232.27 13.82 34 99254 223767 64175677
Enthesopathy 228.33 13.82 157 99131 9481 64389963
Therapy cessation 183.47 13.82 238 99050 32251 64367193
Therapeutic response shortened 182.45 13.82 140 99148 10030 64389414
Macule 178.17 13.82 83 99205 2343 64397101
Death 176.56 13.82 295 98993 482410 63917034
Ankylosing spondylitis 173.82 13.82 125 99163 8109 64391335
Skin haemorrhage 169.14 13.82 125 99163 8460 64390984
Hyponatraemia 167.42 13.82 17 99271 148322 64251122
Peripheral swelling 166.33 13.82 700 98588 208453 64190991
Rhinorrhoea 165.42 13.82 316 98972 59653 64339791
Product prescribing error 163.78 13.82 235 99053 35034 64364410
Seronegative arthritis 162.53 13.82 81 99207 2662 64396782
Pancytopenia 160.24 13.82 17 99271 143292 64256152
Infection 159.03 13.82 634 98654 184246 64215198
Malignant neoplasm progression 158.72 13.82 3 99285 112868 64286576
Inflammatory bowel disease 154.78 13.82 93 99195 4445 64394999
Respiratory failure 152.88 13.82 31 99257 161152 64238292
Injection site haemorrhage 149.98 13.82 186 99102 24092 64375352
Decreased immune responsiveness 148.72 13.82 90 99198 4358 64395086
Uveitis 145.40 13.82 135 99153 12573 64386871
Platelet count decreased 140.14 13.82 42 99246 167669 64231775
Injection site bruising 139.93 13.82 222 99066 36151 64363293
Product storage error 136.26 13.82 133 99155 13185 64386259
Neck pain 136.19 13.82 296 98992 61237 64338207
Dactylitis 135.22 13.82 64 99224 1874 64397570
Confusional state 133.73 13.82 123 99165 261021 64138423
Therapeutic product effect decreased 132.66 13.82 435 98853 114916 64284528
Bradycardia 132.22 13.82 14 99274 118205 64281239
Cardiac arrest 131.63 13.82 37 99251 154027 64245417
Overdose 131.44 13.82 41 99247 159525 64239919
Renal failure 130.69 13.82 58 99230 181630 64217814
Treatment failure 129.42 13.82 435 98853 116381 64283063
Constipation 128.49 13.82 99 99189 229238 64170206
Illness 127.44 13.82 163 99125 21775 64377669
Skin fissures 126.73 13.82 114 99174 10192 64389252
Hypokalaemia 125.29 13.82 19 99269 121884 64277560
Disease progression 124.86 13.82 32 99256 141648 64257796
Haemoglobin decreased 124.30 13.82 73 99215 194990 64204454
Spinal pain 123.47 13.82 123 99165 12498 64386946
Rhabdomyolysis 123.04 13.82 4 99284 91722 64307722
White blood cell count decreased 120.61 13.82 46 99242 157791 64241653
Oral candidiasis 115.67 13.82 160 99128 23052 64376392
Cardio-respiratory arrest 114.39 13.82 10 99278 98383 64301061
Ear infection 113.16 13.82 159 99129 23245 64376199
Hyperkalaemia 113.03 13.82 12 99276 101117 64298327
Dislocation of vertebra 111.69 13.82 66 99222 3058 64396386
Depressed level of consciousness 111.24 13.82 3 99285 81433 64318011
Tonsillitis 108.54 13.82 82 99206 5738 64393706
Seizure 106.96 13.82 62 99226 166830 64232614
Pharyngitis streptococcal 104.85 13.82 95 99193 8573 64390871
International normalised ratio increased 104.27 13.82 4 99284 79163 64320281
Gastrointestinal haemorrhage 103.71 13.82 37 99251 132275 64267169
Tenosynovitis 102.48 13.82 108 99180 11725 64387719
Tendonitis 101.36 13.82 140 99148 20142 64379302
Movement disorder 101.26 13.82 146 99142 21854 64377590
Sinusitis 101.18 13.82 469 98819 145459 64253985
Dehydration 100.76 13.82 111 99177 216652 64182792
Wrong technique in device usage process 100.72 13.82 60 99228 2822 64396622
C-reactive protein increased 100.34 13.82 348 98940 94561 64304883
Synovitis 100.17 13.82 358 98930 98732 64300712
Electrocardiogram QT prolonged 98.28 13.82 6 99282 79442 64320002
Intentional product misuse 97.51 13.82 3 99285 72292 64327152
Multiple organ dysfunction syndrome 97.19 13.82 19 99269 101394 64298050
Insurance issue 96.60 13.82 58 99230 2768 64396676
Concomitant disease aggravated 95.81 13.82 103 99185 11439 64388005
Cardiac failure 95.57 13.82 42 99246 132331 64267113
Pleural effusion 94.84 13.82 38 99250 126521 64272923
Scab 93.98 13.82 91 99197 8931 64390513
Coma 93.92 13.82 12 99276 87603 64311841
Cardiac failure congestive 93.38 13.82 42 99246 130538 64268906
Product dispensing error 92.98 13.82 101 99187 11349 64388095
Incorrect dose administered by device 92.95 13.82 65 99223 4032 64395412
Neutrophil count decreased 92.07 13.82 7 99281 77189 64322255
Mycotic allergy 91.92 13.82 40 99248 958 64398486
Pain of skin 91.47 13.82 92 99196 9455 64389989
Tachycardia 91.07 13.82 59 99229 149520 64249924
Oxygen saturation decreased 91.04 13.82 26 99262 107150 64292294
Erythema 90.97 13.82 545 98743 186525 64212919
Off label use 90.05 13.82 588 98700 632218 63767226
Stress 90.03 13.82 250 99038 60284 64339160
Hypoxia 89.97 13.82 14 99274 88135 64311309
Red blood cell sedimentation rate increased 87.84 13.82 166 99122 31069 64368375
Somnolence 87.45 13.82 111 99177 203534 64195910
Drug tolerance decreased 87.21 13.82 78 99210 6920 64392524
Syncope 87.04 13.82 69 99219 157566 64241878
Vein rupture 86.82 13.82 44 99244 1499 64397945
Fear of injection 86.04 13.82 72 99216 5840 64393604
Back pain 85.98 13.82 669 98619 249502 64149942
Secretion discharge 85.95 13.82 99 99189 11865 64387579
Sacroiliitis 85.68 13.82 55 99233 2957 64396487
Cough 85.27 13.82 773 98515 301375 64098069
Colitis ulcerative 85.07 13.82 138 99150 22890 64376554
Erysipelas 84.25 13.82 86 99202 8995 64390449
Dry skin 83.83 13.82 219 99069 50942 64348502
Intentional overdose 83.81 13.82 18 99270 89926 64309518
Discomfort 83.27 13.82 294 98994 80584 64318860
Metabolic acidosis 83.05 13.82 7 99281 70951 64328493
Mobility decreased 82.41 13.82 305 98983 85535 64313909
Limb discomfort 82.16 13.82 149 99139 27026 64372418
Sepsis 81.95 13.82 143 99145 230198 64169246
Product distribution issue 81.82 13.82 35 99253 803 64398641
Scratch 80.22 13.82 72 99216 6417 64393027
Skin disorder 80.19 13.82 149 99139 27531 64371913
Incorrect route of product administration 79.86 13.82 135 99153 23163 64376281
Pulmonary embolism 79.63 13.82 65 99223 146291 64253153
Grip strength decreased 79.20 13.82 94 99194 11630 64387814
Lower respiratory tract infection 78.47 13.82 321 98967 94293 64305151
Vomiting 77.38 13.82 514 98774 550603 63848841
Hyperglycaemia 77.27 13.82 4 99284 60964 64338480
Epistaxis 75.94 13.82 28 99260 98103 64301341
Joint stiffness 75.09 13.82 153 99135 30251 64369193
Lactic acidosis 74.88 13.82 5 99283 61405 64338039
Hallucination 73.29 13.82 12 99276 72776 64326668
Nail psoriasis 73.11 13.82 26 99262 356 64399088
Agitation 72.22 13.82 23 99265 88344 64311100
Loss of consciousness 71.11 13.82 74 99214 148291 64251153
Renal impairment 70.95 13.82 62 99226 134955 64264489
Red blood cell sedimentation rate 70.75 13.82 53 99235 3661 64395783
Hypoglycaemia 70.67 13.82 25 99263 89867 64309577
Drug intolerance 69.76 13.82 512 98776 187480 64211964
Arthropathy 69.74 13.82 369 98919 120598 64278846
Atrial fibrillation 69.62 13.82 97 99191 170992 64228452
Blood creatine phosphokinase increased 67.92 13.82 6 99282 58552 64340892
Dyspnoea 67.80 13.82 744 98544 717930 63681514
Injection site pain 67.10 13.82 344 98944 111064 64288380
Accidental exposure to product 66.69 13.82 134 99154 26230 64373214
Mental status changes 66.47 13.82 8 99280 61154 64338290
Gait disturbance 65.67 13.82 472 98816 171683 64227761
Drug reaction with eosinophilia and systemic symptoms 64.42 13.82 5 99283 54212 64345232
Burning sensation 64.11 13.82 195 99093 49469 64349975
Nasal congestion 63.24 13.82 219 99069 59439 64340005
Encephalopathy 63.17 13.82 8 99280 58811 64340633
Respiratory arrest 62.63 13.82 5 99283 52980 64346464
Medication error 61.12 13.82 4 99284 49962 64349482
Septic shock 60.95 13.82 44 99244 105393 64294051
Acne 60.41 13.82 119 99169 22962 64376482
Pulmonary oedema 59.95 13.82 23 99265 78651 64320793
Fungal infection 59.60 13.82 150 99138 34101 64365343
Tremor 58.37 13.82 86 99202 148144 64251300
Product dose omission issue 58.35 13.82 505 98783 194242 64205202
Bone marrow failure 58.18 13.82 4 99284 47948 64351496
Type 2 diabetes mellitus 58.17 13.82 148 99140 33872 64365572
Feeling abnormal 57.88 13.82 378 98910 133224 64266220
Swollen joint count increased 57.56 13.82 65 99223 7624 64391820
Psoriasis area severity index increased 57.09 13.82 16 99272 93 64399351
Gastrointestinal pain 56.65 13.82 64 99224 7510 64391934
Venous injury 55.03 13.82 24 99264 578 64398866
Cellulitis 54.87 13.82 287 99001 93370 64306074
Hepatic function abnormal 53.88 13.82 16 99272 64297 64335147
Wound 53.84 13.82 247 99041 76230 64323214
SARS-CoV-2 test positive 53.77 13.82 57 99231 6229 64393215
Unresponsive to stimuli 53.76 13.82 7 99281 50386 64349058
Cholestasis 53.70 13.82 4 99284 44868 64354576
Sinus congestion 53.63 13.82 90 99198 15349 64384095
Influenza like illness 53.27 13.82 212 99076 61490 64337954
Aggression 52.91 13.82 5 99283 46227 64353217
Pustular psoriasis 52.87 13.82 47 99241 4136 64395308
Tonsillar ulcer 52.79 13.82 21 99267 398 64399046
Plasma cell myeloma 52.69 13.82 5 99283 46070 64353374
Gait inability 52.49 13.82 164 99124 42204 64357240
Hypocalcaemia 52.10 13.82 3 99285 41750 64357694
Mucosal inflammation 51.65 13.82 16 99272 62568 64336876
Respiratory tract congestion 50.61 13.82 90 99198 16075 64383369
Oedema peripheral 50.42 13.82 161 99127 210156 64189288
Spondylitis 49.98 13.82 40 99248 3046 64396398
Fibromyalgia 49.63 13.82 144 99144 35587 64363857
Fall 49.20 13.82 408 98880 416418 63983026
Spondyloarthropathy 48.91 13.82 24 99264 762 64398682
Abdominal discomfort 48.60 13.82 461 98827 181861 64217583
Tooth abscess 48.56 13.82 81 99207 13745 64385699
Cutaneous T-cell lymphoma 48.03 13.82 35 99253 2317 64397127
Therapy non-responder 48.00 13.82 215 99073 65684 64333760
Eczema 47.43 13.82 126 99162 29594 64369850
Bursitis 47.11 13.82 103 99185 21382 64378062
Joint injury 46.93 13.82 107 99181 22840 64376604
Hepatocellular injury 46.57 13.82 7 99281 45228 64354216
Cystitis 46.40 13.82 158 99130 42517 64356927
Orthostatic hypotension 46.40 13.82 8 99280 46730 64352714
Ligament calcification 45.95 13.82 16 99272 205 64399239
Body temperature decreased 45.58 13.82 114 99174 25814 64373630
Melaena 45.44 13.82 13 99275 53535 64345909
Panniculitis 45.43 13.82 62 99226 8817 64390627
Interstitial lung disease 45.42 13.82 50 99238 97682 64301762
Suicide attempt 44.59 13.82 27 99261 70980 64328464
Alanine aminotransferase abnormal 44.52 13.82 54 99234 6834 64392610
Neuropathy peripheral 44.51 13.82 70 99218 117455 64281989
Acute respiratory failure 44.50 13.82 11 99277 49923 64349521
Sneezing 44.05 13.82 82 99206 15169 64384275
Generalised tonic-clonic seizure 43.84 13.82 5 99283 39852 64359592
Blood bilirubin increased 43.56 13.82 17 99271 57536 64341908
Localised infection 43.29 13.82 123 99165 30038 64369406
Blood parathyroid hormone decreased 43.20 13.82 55 99233 7311 64392133
Palmoplantar pustulosis 42.80 13.82 19 99269 478 64398966
Musculoskeletal discomfort 42.69 13.82 84 99204 16193 64383251
Cytomegalovirus infection 42.63 13.82 4 99284 37195 64362249
Leukopenia 42.58 13.82 56 99232 101186 64298258
Retinitis 42.52 13.82 31 99257 2054 64397390
Coronary artery disease 42.31 13.82 20 99268 60413 64339031
Adjustment disorder with depressed mood 42.27 13.82 33 99255 2424 64397020
Spinal fusion surgery 42.18 13.82 39 99249 3612 64395832
Cognitive disorder 42.14 13.82 16 99272 55071 64344373
Hypermobility syndrome 41.98 13.82 19 99269 501 64398943
Tenderness 41.88 13.82 93 99195 19509 64379935
Skin burning sensation 41.25 13.82 65 99223 10518 64388926
Altered state of consciousness 41.08 13.82 5 99283 37897 64361547
Wound infection 40.56 13.82 78 99210 14786 64384658
Hypomagnesaemia 40.34 13.82 5 99283 37371 64362073
Hypersensitivity 40.24 13.82 471 98817 195981 64203463
Urinary retention 39.85 13.82 13 99275 49188 64350256
Upper gastrointestinal haemorrhage 39.80 13.82 4 99284 35216 64364228
Pneumonitis 39.59 13.82 14 99274 50351 64349093
Liver function test abnormal 39.57 13.82 21 99267 59380 64340064
Laryngitis 39.24 13.82 65 99223 10966 64388478
Shock 39.18 13.82 6 99282 38234 64361210
Lower respiratory tract infection viral 39.00 13.82 22 99266 933 64398511
Balance disorder 38.93 13.82 43 99245 83883 64315561
Rheumatic fever 38.91 13.82 59 99229 9235 64390209
Cerebral haemorrhage 38.81 13.82 15 99273 51075 64348369
C-reactive protein abnormal 38.37 13.82 115 99173 28932 64370512
Pericardial effusion 38.35 13.82 7 99281 39247 64360197
Pneumonia aspiration 37.97 13.82 22 99266 59249 64340195
Anosmia 37.69 13.82 40 99248 4377 64395067
Decreased appetite 37.54 13.82 266 99022 281023 64118421
Tongue disorder 37.49 13.82 67 99221 12013 64387431
Rash maculo-papular 37.09 13.82 13 99275 47013 64352431
Accident 36.85 13.82 49 99239 6797 64392647
Blister 36.84 13.82 232 99056 80735 64318709
Papule 36.59 13.82 47 99241 6303 64393141
Skin irritation 36.57 13.82 57 99231 9137 64390307
Abscess limb 36.13 13.82 46 99242 6115 64393329
Headache 36.05 13.82 1068 98220 528399 63871045
Mouth ulceration 36.04 13.82 121 99167 32323 64367121
Muscle swelling 35.85 13.82 19 99269 711 64398733
Sinus tachycardia 35.49 13.82 4 99284 32184 64367260
Rheumatoid nodule 35.27 13.82 67 99221 12584 64386860
Coagulopathy 35.11 13.82 4 99284 31916 64367528
Device issue 35.11 13.82 95 99193 22553 64376891
Chronic kidney disease 35.02 13.82 23 99265 57896 64341548
Deep vein thrombosis 34.97 13.82 68 99220 105114 64294330
Multiple sclerosis relapse 34.88 13.82 10 99278 41125 64358319
Skin swelling 34.80 13.82 31 99257 2735 64396709
Bone lesion 34.39 13.82 41 99247 5096 64394348
Symptom recurrence 34.19 13.82 20 99268 909 64398535
Bronchitis 34.12 13.82 285 99003 108458 64290986
Jaundice 34.05 13.82 16 99272 48496 64350948
Disorientation 33.98 13.82 22 99266 55806 64343638
Pulmonary hypertension 33.89 13.82 12 99276 43127 64356317
Stevens-Johnson syndrome 33.69 13.82 6 99282 34243 64365201
Pancreatitis acute 33.53 13.82 12 99276 42843 64356601
Guttate psoriasis 33.48 13.82 15 99273 386 64399058
Hypophagia 32.88 13.82 10 99278 39577 64359867
Dyspnoea exertional 32.87 13.82 39 99249 73691 64325753
Abnormal behaviour 32.84 13.82 6 99282 33616 64365828
Therapeutic product effect delayed 32.84 13.82 29 99259 2530 64396914
Respiratory tract infection 32.66 13.82 129 99159 37278 64362166
Haematocrit decreased 32.64 13.82 22 99266 54633 64344811
Red blood cell count decreased 32.39 13.82 17 99271 48369 64351075
Rheumatoid arthritis 32.35 13.82 391 98897 163903 64235541
Joint dislocation 32.31 13.82 61 99227 11404 64388040
Nail disorder 32.28 13.82 52 99236 8572 64390872
Blood potassium decreased 32.15 13.82 11 99277 40388 64359056
Pustule 31.77 13.82 22 99266 1343 64398101
Ventricular tachycardia 31.62 13.82 7 99281 34258 64365186
Loose body in joint 31.61 13.82 21 99267 1197 64398247
Tubulointerstitial nephritis 31.33 13.82 5 99283 30904 64368540
Kidney infection 30.90 13.82 78 99210 17760 64381684
Dyskinesia 30.87 13.82 11 99277 39377 64360067
Injection site papule 30.82 13.82 18 99270 816 64398628
Rebound psoriasis 30.77 13.82 11 99277 153 64399291
Aphthous ulcer 30.75 13.82 64 99224 12842 64386602
Ascites 30.75 13.82 30 99258 61971 64337473
Haematemesis 30.74 13.82 17 99271 46982 64352462
Carotid artery thrombosis 30.65 13.82 24 99264 1771 64397673
Neurologic neglect syndrome 30.62 13.82 23 99265 1595 64397849
Blood urea increased 30.32 13.82 15 99273 44138 64355306
Axial spondyloarthritis 30.09 13.82 14 99274 394 64399050
Respiratory distress 30.02 13.82 22 99266 52309 64347135
Ear infection fungal 29.65 13.82 11 99277 171 64399273
Diverticulitis 29.64 13.82 128 99160 38490 64360954
Blood pressure fluctuation 29.51 13.82 22 99266 51849 64347595
Rhesus antigen positive 29.02 13.82 10 99278 124 64399320
Lupus-like syndrome 28.89 13.82 50 99238 8741 64390703
Coronavirus infection 28.88 13.82 39 99249 5491 64393953
Acute myeloid leukaemia 28.85 13.82 4 99284 27459 64371985
Urticaria 28.74 13.82 350 98938 146967 64252477
Hepatic enzyme abnormal 28.71 13.82 40 99248 5799 64393645
Atelectasis 28.58 13.82 4 99284 27262 64372182
Disability 28.58 13.82 60 99228 12112 64387332
Rheumatoid factor positive 28.52 13.82 118 99170 34820 64364624
Nephrolithiasis 28.48 13.82 138 99150 43545 64355899
Skin infection 28.44 13.82 68 99220 14969 64384475
Prescribed overdose 28.29 13.82 82 99206 20249 64379195
Psychotic disorder 28.24 13.82 9 99279 34569 64364875
Cerebral infarction 28.10 13.82 14 99274 41030 64358414
Heart rate decreased 28.06 13.82 26 99262 55041 64344403
Onychomadesis 28.01 13.82 28 99260 2856 64396588
Pyoderma gangrenosum 27.97 13.82 29 99259 3089 64396355
Lymphocyte count decreased 27.68 13.82 14 99274 40685 64358759
Tachypnoea 27.61 13.82 4 99284 26567 64372877
Body surface area increased 27.60 13.82 9 99279 93 64399351
Eosinophilia 27.59 13.82 12 99276 38064 64361380
Fatigue 27.57 13.82 1412 97876 747318 63652126
Basal cell carcinoma 27.45 13.82 107 99181 30731 64368713
Asthenia 27.33 13.82 479 98809 427565 63971879
Skin ulcer 27.30 13.82 137 99151 43837 64355607
Drug resistance 27.18 13.82 10 99278 35092 64364352
Rash pustular 27.12 13.82 52 99236 9833 64389611
Acute respiratory distress syndrome 27.08 13.82 13 99275 38922 64360522
Abscess sweat gland 27.00 13.82 6 99282 10 64399434
Epilepsy 26.91 13.82 9 99279 33522 64365922
Myelodysplastic syndrome 26.77 13.82 5 99283 27574 64371870
Intentional self-injury 26.67 13.82 6 99282 29038 64370406
Angiocardiogram 26.57 13.82 11 99277 232 64399212
Tendon pain 26.56 13.82 35 99253 4813 64394631
Xyphoid retraction 26.52 13.82 10 99278 163 64399281
Dysstasia 26.16 13.82 87 99201 23128 64376316
Oral lichen planus 25.96 13.82 15 99273 666 64398778
Haematuria 25.88 13.82 33 99255 60438 64339006
Thrombosis 25.87 13.82 43 99245 70599 64328845
Haematoma 25.82 13.82 20 99268 46230 64353214
Diabetic ketoacidosis 25.78 13.82 7 99281 29838 64369606
Ulcer 25.76 13.82 86 99202 22904 64376540
Tinea pedis 25.74 13.82 23 99265 2038 64397406
Candida infection 25.56 13.82 106 99182 31313 64368131
Osteoarthritis 25.48 13.82 176 99112 63160 64336284
Blood sodium decreased 25.31 13.82 7 99281 29475 64369969
Lichen planus 25.23 13.82 24 99264 2304 64397140
Hepatitis 25.08 13.82 20 99268 45562 64353882
Pancreatitis 25.03 13.82 33 99255 59574 64339870
Oral pain 24.96 13.82 96 99192 27397 64372047
Nasal discomfort 24.88 13.82 32 99256 4296 64395148
Granuloma skin 24.64 13.82 38 99250 6036 64393408
Hypothyroidism 24.55 13.82 16 99272 40441 64359003
Genital candidiasis 24.50 13.82 8 99280 83 64399361
Rash 24.48 13.82 899 98389 457650 63941794
Eye infection 24.46 13.82 48 99240 9233 64390211
Lip ulceration 24.33 13.82 22 99266 1979 64397465
Body mass index abnormal 24.24 13.82 10 99278 209 64399235
Dizziness 24.18 13.82 492 98796 429671 63969773
Exostosis 24.13 13.82 54 99234 11384 64388060
Ocular hyperaemia 24.05 13.82 83 99205 22481 64376963
Mitral valve incompetence 24.01 13.82 5 99283 25533 64373911
Dermatitis exfoliative generalised 23.98 13.82 37 99251 5879 64393565
Presyncope 23.97 13.82 12 99276 35077 64364367
Intestinal obstruction 23.92 13.82 13 99275 36273 64363171
Pharyngitis 23.86 13.82 74 99214 18965 64380479
Cyanosis 23.82 13.82 3 99285 22152 64377292
Blood alkaline phosphatase increased 23.79 13.82 31 99257 56248 64343196
Manufacturing product shipping issue 23.76 13.82 8 99280 92 64399352
Scarlet fever 23.76 13.82 8 99280 92 64399352
Brain oedema 23.71 13.82 3 99285 22072 64377372
Energy increased 23.57 13.82 25 99263 2733 64396711
Sinus disorder 23.34 13.82 68 99220 16840 64382604
Product availability issue 23.28 13.82 22 99266 2094 64397350
Genital cyst 23.27 13.82 7 99281 54 64399390
Blood lactate dehydrogenase increased 23.07 13.82 11 99277 33067 64366377
Meningitis streptococcal 22.80 13.82 9 99279 167 64399277
Leukocytosis 22.80 13.82 15 99273 37725 64361719
Acute hepatic failure 22.79 13.82 6 99282 26106 64373338
Viral infection 22.72 13.82 113 99175 36027 64363417
Skin discolouration 22.71 13.82 111 99177 35144 64364300
Breast cancer 22.67 13.82 97 99191 29051 64370393
Productive cough 22.50 13.82 191 99097 73012 64326432
Vulval cancer stage III 22.26 13.82 5 99283 9 64399435
Product quality issue 22.22 13.82 9 99279 29790 64369654
Lymphopenia 22.20 13.82 6 99282 25651 64373793
Granuloma 22.12 13.82 38 99250 6603 64392841
Blood calcium decreased 22.06 13.82 6 99282 25548 64373896
Hepatic failure 21.92 13.82 32 99256 55362 64344082
Blood creatinine increased 21.92 13.82 121 99167 135661 64263783
Musculoskeletal pain 21.85 13.82 206 99082 81088 64318356
Cardiomyopathy 21.80 13.82 6 99282 25350 64374094
Joint ankylosis 21.77 13.82 14 99274 755 64398689
Electrolyte imbalance 21.66 13.82 6 99282 25237 64374207
Arrhythmia 21.53 13.82 30 99258 52914 64346530
Renal tubular necrosis 21.48 13.82 4 99284 22106 64377338
Tooth infection 21.40 13.82 60 99228 14541 64384903
Disturbance in attention 21.39 13.82 19 99269 41055 64358389
Pallor 21.35 13.82 17 99271 38764 64360680
Urinary tract infection 21.18 13.82 486 98802 231110 64168334
Fluid retention 21.17 13.82 37 99251 59569 64339875
Haemorrhage 20.97 13.82 58 99230 79293 64320151
Drug-device interaction 20.91 13.82 7 99281 79 64399365
Hypothermia 20.61 13.82 3 99285 19853 64379591
Ileus 20.58 13.82 5 99283 22961 64376483
Tuberculosis 20.52 13.82 55 99233 12983 64386461
Transaminases increased 20.51 13.82 23 99265 44571 64354873
Skin discomfort 20.50 13.82 12 99276 546 64398898
Erythematotelangiectatic rosacea 20.48 13.82 5 99283 15 64399429
Dyshidrotic eczema 20.42 13.82 12 99276 550 64398894
Flushing 20.41 13.82 58 99230 78590 64320854
Inflammatory pain 20.40 13.82 14 99274 842 64398602
Furuncle 20.37 13.82 36 99252 6397 64393047
Ear infection bacterial 20.33 13.82 6 99282 43 64399401
Tinea versicolour 20.31 13.82 10 99278 320 64399124
Lip dry 20.27 13.82 31 99257 4887 64394557
Oligoarthritis 20.25 13.82 10 99278 322 64399122
Skin necrosis 20.14 13.82 58 99230 14271 64385173
Latent tuberculosis 20.12 13.82 23 99265 2734 64396710
Myocardial infarction 20.10 13.82 161 99127 165660 64233784
Hepatic encephalopathy 20.06 13.82 4 99284 21062 64378382
White blood cell count increased 19.98 13.82 45 99243 65969 64333475
Acute myocardial infarction 19.92 13.82 49 99239 69669 64329775
Swelling 19.91 13.82 352 98936 159866 64239578
Conjunctivitis viral 19.85 13.82 8 99280 157 64399287
Chronic disease 19.61 13.82 7 99281 97 64399347
Knee arthroplasty 19.59 13.82 88 99200 26911 64372533
Cutaneous lymphoma 19.58 13.82 9 99279 246 64399198
Tongue discolouration 19.52 13.82 25 99263 3343 64396101
Hypokinesia 19.42 13.82 63 99225 16533 64382911
Hepatic cirrhosis 19.29 13.82 86 99202 26212 64373232
Therapeutic response decreased 19.24 13.82 142 99146 52046 64347398
Oral discomfort 19.23 13.82 41 99247 8365 64391079
Purulent discharge 19.19 13.82 32 99256 5429 64394015
Papulopustular rosacea 19.18 13.82 5 99283 21 64399423
Laryngitis viral 19.18 13.82 5 99283 21 64399423
Self-consciousness 19.15 13.82 4 99284 4 64399440
Breast cancer stage III 19.14 13.82 23 99265 2882 64396562
Full blood count abnormal 19.12 13.82 11 99277 29746 64369698
Drug dependence 19.11 13.82 14 99274 33298 64366146
Clostridium difficile colitis 19.07 13.82 9 99279 27214 64372230
Groin infection 19.01 13.82 11 99277 490 64398954
Nervousness 19.00 13.82 93 99195 29463 64369981
Obstructive airways disorder 19.00 13.82 6 99282 23179 64376265
Infected dermal cyst 18.99 13.82 13 99275 779 64398665
Intestinal haemorrhage 18.96 13.82 32 99256 5482 64393962
Cell marker increased 18.95 13.82 12 99276 630 64398814
Onychalgia 18.91 13.82 13 99275 784 64398660
Oral pustule 18.84 13.82 9 99279 269 64399175
Dysgeusia 18.79 13.82 27 99261 47020 64352424
Device related infection 18.73 13.82 12 99276 30614 64368830
Bacteraemia 18.69 13.82 9 99279 26902 64372542
Pericarditis 18.63 13.82 162 99126 62354 64337090
Polyneuropathy 18.49 13.82 4 99284 19890 64379554
Diabetes mellitus inadequate control 18.42 13.82 5 99283 21316 64378128
Near death experience 18.31 13.82 10 99278 398 64399046
Metastases to liver 18.23 13.82 7 99281 23934 64375510
Full blood count decreased 18.23 13.82 6 99282 22576 64376868
Oral lichenoid reaction 18.14 13.82 6 99282 65 64399379
Eating disorder 18.07 13.82 62 99226 16743 64382701
Oesophageal infection 18 13.82 11 99277 542 64398902
Chronic obstructive pulmonary disease 17.99 13.82 53 99235 70995 64328449
Collagen-vascular disease 17.98 13.82 6 99282 67 64399377
Angioimmunoblastic T-cell lymphoma 17.97 13.82 10 99278 413 64399031
Ejection fraction decreased 17.90 13.82 11 99277 28696 64370748
Pseudomonas infection 17.88 13.82 3 99285 17880 64381564
Lung infiltration 17.85 13.82 5 99283 20884 64378560
Hand dermatitis 17.78 13.82 8 99280 208 64399236
Product use issue 17.68 13.82 330 98958 151385 64248059
Aspartate aminotransferase increased 17.60 13.82 110 99178 119678 64279766
Wrong schedule 17.59 13.82 9 99279 313 64399131
Dermatitis psoriasiform 17.54 13.82 19 99269 2127 64397317
Rhinitis 17.54 13.82 46 99242 10719 64388725
Night sweats 17.47 13.82 105 99183 35941 64363503
Supraventricular tachycardia 17.17 13.82 4 99284 18903 64380541
Palate injury 17.05 13.82 5 99283 35 64399409
Gastrooesophageal reflux disease 17.00 13.82 68 99220 83075 64316369
Adjustment disorder 16.90 13.82 21 99267 2724 64396720
Peritonsillar abscess 16.83 13.82 12 99276 768 64398676
Alopecia 16.82 13.82 353 98935 165337 64234107
Petechiae 16.80 13.82 4 99284 18622 64380822
Proteinuria 16.77 13.82 11 99277 27712 64371732
Premature delivery 16.75 13.82 4 99284 18585 64380859
Iridocyclitis 16.70 13.82 22 99266 3023 64396421
Oral herpes 16.67 13.82 73 99215 22079 64377365
Streptococcal infection 16.56 13.82 36 99252 7443 64392001
Subarachnoid haemorrhage 16.55 13.82 4 99284 18434 64381010
HLA-B*27 positive 16.49 13.82 6 99282 88 64399356
Sleep disorder due to general medical condition, insomnia type 16.47 13.82 10 99278 26260 64373184
Plantar fasciitis 16.45 13.82 21 99267 2799 64396645
Migraine 16.43 13.82 158 99130 62519 64336925
Adrenal insufficiency 16.43 13.82 7 99281 22480 64376964
Colitis 16.43 13.82 150 99138 58524 64340920
Bone erosion 16.36 13.82 47 99241 11548 64387896
Cardiomegaly 16.33 13.82 8 99280 23676 64375768
Diarrhoea haemorrhagic 16.32 13.82 46 99242 11181 64388263
Intercepted product prescribing error 16.30 13.82 8 99280 254 64399190
Vaginal infection 16.19 13.82 28 99260 4892 64394552
Skin injury 16.15 13.82 18 99270 2081 64397363
Feeling hot 16.13 13.82 123 99165 45540 64353904
Blood pressure decreased 16.09 13.82 73 99215 86126 64313318
Hepatic mass 15.97 13.82 18 99270 2106 64397338
Otitis externa 15.86 13.82 18 99270 2123 64397321
Skin oedema 15.83 13.82 15 99273 1433 64398011
Product substitution issue 15.79 13.82 4 99284 17857 64381587
Cardiac failure acute 15.78 13.82 3 99285 16341 64383103
Facet joint syndrome 15.78 13.82 17 99271 1892 64397552
Injection site paraesthesia 15.77 13.82 10 99278 526 64398918
Ageusia 15.77 13.82 52 99236 13761 64385683
Iron deficiency anaemia 15.70 13.82 7 99281 21882 64377562
Anuria 15.37 13.82 5 99283 18959 64380485
Pneumocystis jirovecii pneumonia 15.36 13.82 12 99276 27622 64371822
Laboratory test abnormal 15.31 13.82 9 99279 24054 64375390
Dermatologic examination abnormal 15.31 13.82 4 99284 17 64399427
Device dispensing error 15.27 13.82 6 99282 110 64399334
Chondrocalcinosis 15.22 13.82 11 99277 719 64398725
Ear neoplasm 15.12 13.82 6 99282 113 64399331
Peritonitis 15.04 13.82 10 99278 25013 64374431
Glossodynia 14.99 13.82 159 99129 64537 64334907
Motor dysfunction 14.99 13.82 45 99243 11328 64388116
Spinal disorder 14.96 13.82 38 99250 8684 64390760
Hepatotoxicity 14.93 13.82 24 99264 39938 64359506
Oesophageal candidiasis 14.89 13.82 36 99252 7981 64391463
Pigmentation disorder 14.85 13.82 26 99262 4586 64394858
Immune system disorder 14.83 13.82 39 99249 9102 64390342
Dysphonia 14.77 13.82 122 99166 46260 64353184
Joint range of motion decreased 14.75 13.82 64 99224 19279 64380165
Pain in jaw 14.74 13.82 25 99263 40730 64358714
Injection site laceration 14.74 13.82 6 99282 121 64399323
Erythrodermic psoriasis 14.73 13.82 15 99273 1564 64397880
Myocarditis 14.72 13.82 4 99284 17039 64382405
Hyperthermia 14.71 13.82 3 99285 15547 64383897
Hidradenitis 14.63 13.82 18 99270 2311 64397133
Hallucination, auditory 14.58 13.82 4 99284 16935 64382509
Dialysis 14.55 13.82 4 99284 16916 64382528
Renal injury 14.55 13.82 3 99285 15426 64384018
Anti-cyclic citrullinated peptide antibody 14.51 13.82 14 99274 1368 64398076
Pregnancy on contraceptive 14.43 13.82 11 99277 780 64398664
Cyst 14.38 13.82 46 99242 11981 64387463
Genital injury 14.36 13.82 3 99285 3 64399441
Gynaecological examination abnormal 14.36 13.82 3 99285 3 64399441
Blood immunoglobulin M decreased 14.35 13.82 12 99276 972 64398472
Hip arthroplasty 14.31 13.82 68 99220 21283 64378161
Atrial flutter 14.21 13.82 6 99282 19374 64380070
Poisoning 14.18 13.82 8 99280 21871 64377573
Adverse drug reaction 14.17 13.82 119 99169 45345 64354099
Urinary tract pain 14.16 13.82 7 99281 226 64399218
Injection site exfoliation 14.13 13.82 6 99282 135 64399309
Hangover 14.11 13.82 16 99272 1885 64397559
Hyperlipidaemia 14.06 13.82 9 99279 22967 64376477
Myalgia intercostal 14.03 13.82 4 99284 25 64399419
Metastases to bone 13.94 13.82 7 99281 20428 64379016
Blood glucose increased 13.92 13.82 91 99197 97982 64301462
Malnutrition 13.90 13.82 6 99282 19119 64380325
Weight increased 13.82 13.82 238 99050 213110 64186334

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC10 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000191494 Interleukin-17A Antagonists
FDA EPC N0000191495 Interleukin-17A Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Psoriatic arthritis indication 156370009 DOID:9008
Plaque psoriasis indication 200965009
Pustular psoriasis indication 200973000
Non-radiographic axial spondyloarthritis indication 713777005




🐶 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
Interleukin-17A Cytokine ANTIBODY BINDING SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE

External reference:

IDSource
D09967 KEGG_DRUG
4034154 VUID
N0000191427 NUI
4034154 VANDF
CHEMBL1743068 ChEMBL_ID
C555450 MESH_SUPPLEMENTAL_RECORD_UI
8078 IUPHAR_LIGAND_ID
9182 INN_ID
DB09029 DRUGBANK_ID
DLG4EML025 UNII
1599788 RXNORM
232493 MMSL
30871 MMSL
d08341 MMSL
708822004 SNOMEDCT_US
714689007 SNOMEDCT_US
C3179547 UMLSCUI
015879 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
COSENTYX HUMAN PRESCRIPTION DRUG LABEL 1 0078-0639 INJECTION 150 mg SUBCUTANEOUS BLA 31 sections
COSENTYX HUMAN PRESCRIPTION DRUG LABEL 1 0078-1056 INJECTION 75 mg SUBCUTANEOUS BLA 31 sections