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

Stem definitionDrug idCAS RN
human origin 5237 1189541-98-7

Description:

MoleculeDescription

Synonyms:

  • sarilumab
  • REGN88
  • SAR153191
  • kevzara
Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Sarilumab binds to both soluble and membrane-bound IL-6 receptors (sIL-6R and mIL-6R), and has been shown to inhibit IL-6-mediated signaling through these receptors. IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts. IL-6 has been shown to be involved in diverse physiological processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is also produced by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis. Based on encouraging results in China with a similar drug, tocilizumab, a phase 2/3 US study evaluating efficacy and safety of sarilumab in patients hospitalized with severe COVID-19 was performed. At the moment, there are insufficient data to recommend either for or against use of sarilumab for hospitalized patients with COVID-19.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
14.30 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Sept. 27, 2017 PMDA SANOFI KK
May 22, 2017 FDA SANOFI SYNTHELABO
June 23, 2017 EMA sanofi-aventis groupe

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
Joint swelling 1513.49 41.03 3261 184471 500039 89940676
Anti-cyclic citrullinated peptide antibody positive 1231.40 41.03 1944 185788 234489 90206226
Pericarditis 1108.67 41.03 1997 185735 268154 90172561
Hand deformity 1000.27 41.03 2016 185716 294346 90146369
Rheumatoid factor positive 971.00 41.03 1467 186265 170183 90270532
Pemphigus 945.86 41.03 2088 185644 324776 90115939
Glossodynia 881.09 41.03 2011 185721 319768 90120947
Wound 874.76 41.03 1934 185798 301046 90139669
Duodenal ulcer perforation 864.46 41.03 1602 186130 219686 90221029
Hepatic enzyme increased 863.02 41.03 2139 185593 358597 90082118
Systemic lupus erythematosus 858.54 41.03 2139 185593 359757 90080958
Synovitis 799.87 41.03 1966 185766 327786 90112929
Discomfort 765.62 41.03 1728 186004 272607 90168108
Helicobacter infection 760.95 41.03 1540 186192 225310 90215405
Arthralgia 737.75 41.03 3374 184358 775148 89665567
Arthropathy 679.19 41.03 1977 185755 364265 90076450
Rheumatic fever 634.84 41.03 1138 186594 151983 90288732
Blood cholesterol increased 620.29 41.03 1346 186386 206666 90234049
Anaemia 606.33 41.03 30 187702 352772 90087943
Abdominal discomfort 593.89 41.03 2251 185481 475077 89965638
Condition aggravated 585.37 41.03 2611 185121 592934 89847781
Acute kidney injury 581.84 41.03 18 187714 320369 90120346
Swollen joint count increased 577.28 41.03 914 186818 110292 90330423
Pain 570.08 41.03 3765 183967 992576 89448139
Type 2 diabetes mellitus 568.53 41.03 1282 186450 201962 90238753
Toxicity to various agents 559.07 41.03 7 187725 287839 90152876
Alopecia 537.97 41.03 2238 185494 492833 89947882
Blister 529.58 41.03 1435 186297 253563 90187152
Swelling 516.62 41.03 1971 185761 417087 90023628
Hypotension 516.53 41.03 42 187690 325355 90115360
Liver injury 514.36 41.03 1109 186623 169458 90271257
Drug interaction 511.28 41.03 13 187719 276440 90164275
Infusion related reaction 493.88 41.03 1936 185796 414844 90025871
Death 487.31 41.03 169 187563 456382 89984333
Hip arthroplasty 459.99 41.03 672 187060 75536 90365179
Injury 450.75 41.03 1151 186581 196198 90244517
Constipation 418.94 41.03 46 187686 280349 90160366
Mobility decreased 417.43 41.03 1304 186428 249430 90191285
Treatment failure 415.69 41.03 1479 186253 302449 90138266
Knee arthroplasty 414.19 41.03 671 187061 82511 90358204
Loss of personal independence in daily activities 409.12 41.03 884 186848 135221 90305494
Hypersensitivity 389.77 41.03 1917 185815 452760 89987955
Maternal exposure during pregnancy 381.34 41.03 1616 186116 358447 90082268
Contraindicated product administered 381.18 41.03 1490 186242 318649 90122066
Folliculitis 370.22 41.03 1095 186637 203258 90237457
Fibromyalgia 367.74 41.03 1099 186633 205170 90235545
Drug intolerance 361.63 41.03 1856 185876 445735 89994980
Psoriatic arthropathy 355.80 41.03 1161 186571 227174 90213541
Dehydration 352.59 41.03 11 187721 194436 90246279
Muscle injury 351.36 41.03 979 186753 175675 90265040
General physical health deterioration 349.40 41.03 1559 186173 353556 90087159
Musculoskeletal stiffness 337.52 41.03 1361 186371 295171 90145544
Cough 333.72 41.03 174 187558 368788 90071927
Irritable bowel syndrome 321.53 41.03 1053 186679 206395 90234320
Somnolence 318.17 41.03 32 187700 209052 90231663
Fall 313.01 41.03 322 187410 481488 89959227
Facet joint syndrome 310.53 41.03 652 187080 97737 90342978
Product use in unapproved indication 307.56 41.03 1445 186287 334791 90105924
Hypercholesterolaemia 306.20 41.03 658 187074 100234 90340481
Live birth 304.86 41.03 570 187162 78537 90362178
Blood pressure increased 290.37 41.03 34 187698 197183 90243532
Gait inability 285.60 41.03 806 186926 145650 90295065
Breast cancer stage III 282.22 41.03 573 187159 83874 90356841
Disease progression 279.89 41.03 10 187722 156605 90284110
Therapeutic product effect decreased 274.63 41.03 1221 186511 276350 90164365
Grip strength decreased 268.64 41.03 593 187139 91983 90348732
Lip dry 267.76 41.03 624 187108 100331 90340384
Haemoglobin decreased 265.10 41.03 18 187714 161938 90278777
Neutropenia 259.85 41.03 72 187660 224832 90215883
Seizure 258.77 41.03 14 187718 152615 90288100
Sepsis 257.39 41.03 34 187698 179780 90260935
Product use issue 255.00 41.03 1352 186380 328567 90112148
Peripheral venous disease 250.81 41.03 544 187188 83377 90357338
Deep vein thrombosis postoperative 246.81 41.03 489 187243 70320 90370395
Impaired healing 245.17 41.03 1048 186684 233151 90207564
Bursitis 243.54 41.03 711 187021 130943 90309772
Renal failure 242.69 41.03 6 187726 131001 90309714
Syncope 242.30 41.03 7 187725 132656 90308059
Dislocation of vertebra 239.40 41.03 422 187310 55546 90385169
Back pain 236.88 41.03 186 187546 316989 90123726
Joint range of motion decreased 235.23 41.03 716 187016 134927 90305788
Lower respiratory tract infection 234.72 41.03 1085 186647 249574 90191141
Pulmonary embolism 228.17 41.03 10 187722 130810 90309905
Tremor 226.47 41.03 26 187706 153147 90287568
Wound infection 225.69 41.03 604 187128 105798 90334917
Thrombocytopenia 222.84 41.03 77 187655 208648 90232067
Autoimmune disorder 221.98 41.03 491 187241 76253 90364462
Ill-defined disorder 221.71 41.03 863 186869 184028 90256687
Injection site pruritus 220.11 41.03 398 187334 53436 90387279
Adjustment disorder with depressed mood 219.96 41.03 410 187322 56343 90384372
Stomatitis 219.95 41.03 1137 186595 273561 90167154
Atrial fibrillation 218.22 41.03 15 187717 133596 90307119
Nausea 211.69 41.03 1391 186341 1108925 89331790
Injection site rash 207.02 41.03 253 187479 23920 90416795
Respiratory failure 206.70 41.03 9 187723 118409 90322306
Palpitations 205.19 41.03 22 187710 136706 90304009
Urinary tract infection 204.30 41.03 199 187533 305433 90135282
Erythema 199.99 41.03 113 187619 229133 90211582
Chest discomfort 198.40 41.03 26 187706 138339 90302376
Pleural effusion 193.87 41.03 9 187723 111982 90328733
Breast cancer stage II 192.32 41.03 297 187435 35037 90405678
Sleep disorder due to general medical condition, insomnia type 189.22 41.03 642 187090 128052 90312663
Alanine aminotransferase increased 188.37 41.03 15 187717 118323 90322392
Hyperhidrosis 187.52 41.03 29 187703 136276 90304439
Hypokalaemia 187.13 41.03 25 187707 131091 90309624
Aspartate aminotransferase increased 185.92 41.03 6 187726 102931 90337784
X-ray abnormal 184.65 41.03 335 187397 45089 90395626
Blepharospasm 183.77 41.03 375 187357 55070 90385645
Lupus vulgaris 182.77 41.03 332 187400 44727 90395988
Oxygen saturation decreased 181.74 41.03 10 187722 107473 90333242
Heart rate increased 180.58 41.03 14 187718 112888 90327827
Cerebrovascular accident 180.06 41.03 22 187710 123511 90317204
Myocardial infarction 178.74 41.03 10 187722 105962 90334753
Prescribed overdose 177.41 41.03 524 187208 97101 90343614
Feeling abnormal 174.55 41.03 64 187668 167171 90273544
Cardiac failure 173.95 41.03 14 187718 109482 90331233
Pulmonary fibrosis 172.98 41.03 553 187179 106950 90333765
Diarrhoea 172.56 41.03 1189 186543 938001 89502714
Renal impairment 168.81 41.03 13 187719 105408 90335307
Dysphagia 168.64 41.03 18 187714 112260 90328455
Dyspnoea 168.44 41.03 1102 186630 879853 89560862
Platelet count decreased 167.49 41.03 39 187693 136930 90303785
Loss of consciousness 167.44 41.03 42 187690 140196 90300519
Vision blurred 164.85 41.03 18 187714 110275 90330440
Inflammation 164.81 41.03 770 186962 177822 90262893
Intentional product use issue 164.09 41.03 884 186848 216008 90224707
Pancytopenia 162.25 41.03 27 187705 120236 90320479
Myalgia 162.04 41.03 80 187652 175045 90265670
Cardiac failure congestive 158.51 41.03 12 187720 98682 90342033
Gastrointestinal haemorrhage 157.04 41.03 7 187725 90241 90350474
Flushing 156.87 41.03 6 187726 88485 90352230
Adverse event 156.40 41.03 567 187165 116851 90323864
Deep vein thrombosis 153.44 41.03 9 187723 91611 90349104
Night sweats 151.82 41.03 598 187134 128168 90312547
Lower limb fracture 151.32 41.03 453 187279 84560 90356155
Osteoarthritis 147.52 41.03 797 186935 194933 90245782
Ulcer haemorrhage 144.30 41.03 222 187510 26099 90414616
Chills 143.77 41.03 47 187685 131934 90308781
Gait disturbance 143.71 41.03 978 186754 259518 90181197
Gastrointestinal disorder 143.58 41.03 967 186765 255720 90184995
Obesity 141.80 41.03 511 187221 104996 90335719
C-reactive protein abnormal 141.61 41.03 581 187151 126848 90313867
Exostosis 141.45 41.03 329 187403 52805 90387910
Neuropathy peripheral 140.28 41.03 54 187678 136916 90303799
Hepatic cirrhosis 138.07 41.03 363 187369 62890 90377825
Sleep disorder 137.68 41.03 789 186943 197241 90243474
Retinitis 135.68 41.03 267 187465 38191 90402524
Dry mouth 134.34 41.03 743 186989 183316 90257399
Back injury 133.34 41.03 297 187435 46325 90394390
Onychomadesis 132.65 41.03 294 187438 45704 90395011
Epilepsy 132.34 41.03 423 187309 81783 90358932
Nail disorder 132.02 41.03 342 187390 58725 90381990
Epistaxis 129.51 41.03 13 187719 85112 90355603
Hypoaesthesia 128.64 41.03 1100 186632 313110 90127605
C-reactive protein 128.32 41.03 232 187500 31135 90409580
Urticaria 128.12 41.03 1095 186637 311639 90129076
Blood glucose increased 127.12 41.03 22 187710 95224 90345491
Overdose 124.73 41.03 87 187645 157622 90283093
Agitation 124.53 41.03 3 187729 67095 90373620
Walking aid user 123.44 41.03 245 187487 35261 90405454
Wrong technique in product usage process 123.07 41.03 6 187726 71565 90369150
Laryngitis 122.97 41.03 303 187429 50450 90390265
Injection site erythema 122.25 41.03 465 187267 98037 90342678
Bone erosion 121.60 41.03 310 187422 52711 90388004
Dyspnoea exertional 121.35 41.03 7 187725 72281 90368434
Subcutaneous drug absorption impaired 121.25 41.03 145 187587 13400 90427315
Injection site reaction 120.37 41.03 442 187290 91638 90349077
Hyperkalaemia 120.21 41.03 3 187729 64961 90375754
Angioedema 120.03 41.03 3 187729 64873 90375842
Off label use 119.18 41.03 1590 186142 1100662 89340053
Hypoxia 118.58 41.03 8 187724 72391 90368324
Cardio-respiratory arrest 116.51 41.03 3 187729 63137 90377578
Rash 115.75 41.03 2301 185431 793799 89646916
Disability 114.77 41.03 258 187474 40487 90400228
Balance disorder 114.10 41.03 30 187702 97050 90343665
Lethargy 112.88 41.03 4 187728 63135 90377580
Contusion 112.72 41.03 898 186834 250318 90190397
Lung disorder 112.01 41.03 609 187123 149274 90291441
Hallucination 111.92 41.03 6 187726 65953 90374762
Abdominal pain upper 111.62 41.03 1116 186616 331558 90109157
Lupus-like syndrome 111.41 41.03 285 187447 48561 90392154
Wheezing 108.98 41.03 855 186877 237225 90203490
Pyrexia 108.63 41.03 862 186870 659623 89781092
Colitis 108.20 41.03 10 187722 69932 90370783
Oedema 108.04 41.03 748 186984 199547 90241168
Blood pressure decreased 107.52 41.03 14 187718 74881 90365834
Migraine 106.25 41.03 717 187015 189675 90251040
Adverse drug reaction 105.29 41.03 500 187232 116201 90324514
Pulmonary oedema 104.25 41.03 6 187726 62074 90378641
Septic shock 102.80 41.03 24 187708 84136 90356579
Weight decreased 102.34 41.03 422 187310 379488 90061227
Metabolic acidosis 101.42 41.03 3 187729 55673 90385042
Dyspepsia 101.03 41.03 730 187002 197430 90243285
Productive cough 100.24 41.03 19 187713 77044 90363671
Blood pressure systolic increased 99.97 41.03 5 187727 58340 90382375
Tachycardia 98.12 41.03 109 187623 157564 90283151
Hypothyroidism 96.27 41.03 3 187729 53124 90387591
Vomiting 95.96 41.03 1108 186624 787185 89653530
Multiple organ dysfunction syndrome 95.21 41.03 14 187718 68322 90372393
Abdominal pain 94.89 41.03 459 187273 395262 90045453
Multiple sclerosis relapse 94.62 41.03 3 187729 52302 90388413
Sciatica 94.11 41.03 438 187294 100944 90339771
Heart rate decreased 93.58 41.03 4 187728 53501 90387214
Rash vesicular 93.52 41.03 149 187583 18048 90422667
General symptom 92.30 41.03 132 187600 14536 90426179
Prescribed underdose 90.49 41.03 351 187381 74668 90366047
Injection site swelling 89.20 41.03 300 187432 59539 90381176
Influenza 89.17 41.03 94 187638 139170 90301545
Cataract 89.17 41.03 20 187712 72072 90368643
Diabetes mellitus 88.76 41.03 14 187718 64861 90375854
Abortion spontaneous 88.45 41.03 6 187726 54050 90386665
Taste disorder 87.75 41.03 304 187428 61242 90379473
Pustular psoriasis 87.32 41.03 146 187586 18410 90422305
Chronic obstructive pulmonary disease 86.40 41.03 23 187709 73806 90366909
Influenza like illness 85.53 41.03 30 187702 80581 90360134
Blood pressure fluctuation 85.23 41.03 6 187726 52407 90388308
Myelosuppression 84.69 41.03 7 187725 53584 90387131
Delirium 84.09 41.03 433 187299 103926 90336789
Joint stiffness 83.66 41.03 352 187380 77690 90363025
Anti-cyclic citrullinated peptide antibody 83.05 41.03 178 187554 27043 90413672
Hyperglycaemia 82.40 41.03 6 187726 50964 90389751
Stress 81.83 41.03 33 187699 81362 90359353
Thrombosis 81.70 41.03 25 187707 73226 90367489
Liver function test abnormal 79.37 41.03 7 187725 50838 90389877
Ascites 78.99 41.03 5 187727 47735 90392980
Therapy interrupted 77.95 41.03 7 187725 50101 90390614
Haematochezia 77.66 41.03 25 187707 70888 90369827
Product dose omission issue 77.27 41.03 326 187406 291361 90149354
Swelling face 77.00 41.03 36 187696 81316 90359399
Product label confusion 75.05 41.03 154 187578 22696 90418019
Finger deformity 74.04 41.03 191 187541 32706 90408009
Vertigo 74.03 41.03 26 187706 69785 90370930
Hepatic function abnormal 73.28 41.03 6 187726 46282 90394433
Dysphonia 73.17 41.03 20 187712 63064 90377651
Onychomycosis 72.08 41.03 205 187527 37171 90403544
Back disorder 71.84 41.03 162 187570 25469 90415246
Pneumonia aspiration 71.80 41.03 3 187729 40937 90399778
Rash maculo-papular 71.78 41.03 3 187729 40930 90399785
Haemorrhage 71.59 41.03 27 187705 69342 90371373
Cystitis 70.49 41.03 25 187707 66693 90374022
Myositis 70.44 41.03 155 187577 23973 90416742
Dysgeusia 70.44 41.03 12 187720 52548 90388167
Mental status changes 70.15 41.03 6 187726 44673 90396042
Drug tolerance decreased 69.70 41.03 184 187548 31946 90408769
Aphasia 69.32 41.03 5 187727 42807 90397908
Confusional state 69.13 41.03 1154 186578 385051 90055664
Osteonecrosis of jaw 68.13 41.03 3 187729 39100 90401615
Haematoma 68.02 41.03 3 187729 39045 90401670
Blood bilirubin increased 67.81 41.03 6 187726 43464 90397251
Premature delivery 67.45 41.03 3 187729 38759 90401956
Hot flush 66.89 41.03 20 187712 59468 90381247
Road traffic accident 66.53 41.03 416 187316 107210 90333505
Cardiac disorder 66.02 41.03 18 187714 56854 90383861
Dry eye 66.01 41.03 19 187713 57912 90382803
Red blood cell count decreased 65.73 41.03 9 187723 46342 90394373
Urinary retention 65.42 41.03 3 187729 37741 90402974
Cellulitis 65.07 41.03 56 187676 91281 90349434
Bronchitis 65.03 41.03 137 187595 152790 90287925
Eczema 64.72 41.03 15 187717 52855 90387860
Interstitial lung disease 64.68 41.03 39 187693 76366 90364349
Pain in jaw 64.21 41.03 11 187721 47974 90392741
Bone pain 64.17 41.03 24 187708 61959 90378756
Drug ineffective 62.81 41.03 3483 184249 1380815 89059900
Swollen tongue 62.68 41.03 10 187722 45946 90394769
Memory impairment 61.92 41.03 653 187079 196591 90244124
Eye injury 61.88 41.03 94 187638 10926 90429789
Hypophagia 61.82 41.03 3 187729 35934 90404781
Joint dislocation 61.64 41.03 218 187514 44364 90396351
Dry skin 61.53 41.03 55 187677 88018 90352697
C-reactive protein increased 61.47 41.03 610 187122 180779 90259936
Dyskinesia 59.93 41.03 4 187728 36530 90404185
Clostridium difficile infection 59.36 41.03 4 187728 36241 90404474
Herpes zoster 59.34 41.03 65 187667 94579 90346136
Throat irritation 59.24 41.03 14 187718 48681 90392034
Urinary incontinence 59.11 41.03 5 187727 37561 90403154
Neutrophil count decreased 58.50 41.03 38 187694 71494 90369221
Irritability 58.22 41.03 4 187728 35658 90405057
Blood creatine phosphokinase increased 58.02 41.03 3 187729 34020 90406695
Eye irritation 57.93 41.03 3 187729 33975 90406740
Peripheral swelling 57.12 41.03 1186 186546 411920 90028795
Musculoskeletal pain 57.10 41.03 574 187158 170677 90270038
Haematuria 56.80 41.03 4 187728 34933 90405782
Cholestasis 56.65 41.03 5 187727 36294 90404421
Anaphylactic reaction 56.11 41.03 59 187673 87465 90353250
Skin lesion 56.07 41.03 6 187726 37359 90403356
Lymphadenopathy 56.01 41.03 13 187719 45762 90394953
Cerebral haemorrhage 55.99 41.03 4 187728 34518 90406197
Blood potassium decreased 55.60 41.03 15 187717 47712 90393003
Infection 55.56 41.03 1056 186676 361038 90079677
Restlessness 55.53 41.03 5 187727 35715 90405000
Nasopharyngitis 55.38 41.03 1166 186566 405938 90034777
Eye pain 55.13 41.03 12 187720 44156 90396559
Therapy non-responder 55.01 41.03 477 187255 136227 90304488
Pneumonia 54.78 41.03 961 186771 637098 89803617
Angina pectoris 54.60 41.03 8 187724 39152 90401563
Renal disorder 54.52 41.03 7 187725 37852 90402863
Haematemesis 54.43 41.03 4 187728 33722 90406993
Amnesia 54.26 41.03 398 187334 108107 90332608
Overlap syndrome 53.90 41.03 77 187655 8471 90432244
Skin exfoliation 52.97 41.03 38 187694 67875 90372840
Gastritis 52.82 41.03 11 187721 41742 90398973
Vaginal haemorrhage 52.57 41.03 3 187729 31268 90409447
Head injury 52.41 41.03 3 187729 31185 90409530
Candida infection 52.32 41.03 5 187727 34052 90406663
Tooth disorder 52.21 41.03 3 187729 31087 90409628
Agranulocytosis 51.57 41.03 6 187726 34996 90405719
Transient ischaemic attack 51.38 41.03 13 187719 43163 90397552
Haemoptysis 50.91 41.03 5 187727 33315 90407400
Femur fracture 50.90 41.03 16 187716 46066 90394649
Dysuria 50.64 41.03 10 187722 39391 90401324
Sleep apnoea syndrome 50.57 41.03 4 187728 31743 90408972
Altered state of consciousness 50.16 41.03 4 187728 31528 90409187
Drug eruption 49.91 41.03 7 187725 35400 90405315
Ear infection 49.74 41.03 280 187452 69495 90371220
Ocular hyperaemia 49.28 41.03 6 187726 33792 90406923
Foot deformity 49.08 41.03 249 187483 59402 90381313
Hepatic cytolysis 48.96 41.03 4 187728 30912 90409803
Rheumatoid arthritis 48.64 41.03 498 187234 362116 90078599
Infusion site reaction 48.60 41.03 116 187616 18923 90421792
Pancreatitis acute 48.59 41.03 5 187727 32110 90408605
Intentional product misuse 48.37 41.03 69 187663 89535 90351180
Liver function test increased 48.15 41.03 321 187411 84534 90356181
Pericardial effusion 48.07 41.03 9 187723 36824 90403891
Liver disorder 47.67 41.03 421 187311 120848 90319867
Shock 47.65 41.03 3 187729 28775 90411940
Acute respiratory distress syndrome 47.47 41.03 3 187729 28683 90412032
Drug ineffective for unapproved indication 47.30 41.03 41 187691 66603 90374112
Melaena 46.50 41.03 8 187724 34789 90405926
Burning sensation 46.31 41.03 38 187694 63414 90377301
Hepatic steatosis 46.19 41.03 10 187722 36935 90403780
Nephrolithiasis 46.02 41.03 22 187710 49063 90391652
Full blood count abnormal 45.56 41.03 10 187722 36587 90404128
Incorrect dose administered 45.42 41.03 58 187674 78872 90361843
Blood sodium decreased 45.36 41.03 3 187729 27610 90413105
Hypertension 44.84 41.03 1253 186479 456279 89984436
Joint injury 44.79 41.03 7 187725 32657 90408058
Viral infection 44.64 41.03 15 187717 41399 90399316
Flatulence 44.56 41.03 15 187717 41352 90399363
Anxiety 44.23 41.03 419 187313 309353 90131362
Device issue 43.67 41.03 5 187727 29532 90411183
Throat tightness 43.57 41.03 5 187727 29479 90411236
Drug reaction with eosinophilia and systemic symptoms 43.53 41.03 17 187715 42741 90397974
Gastroenteritis 43.09 41.03 5 187727 29224 90411491
Paraesthesia oral 42.93 41.03 7 187725 31652 90409063
Disturbance in attention 42.83 41.03 22 187710 47087 90393628
Arrhythmia 42.81 41.03 17 187715 42315 90398400
Eye pruritus 42.70 41.03 5 187727 29022 90411693
Tinnitus 42.47 41.03 18 187714 43084 90397631
Abdominal pain lower 42.46 41.03 6 187726 30171 90410544
Foetal exposure during pregnancy 42.26 41.03 18 187714 42957 90397758
Pulmonary mass 42.22 41.03 5 187727 28767 90411948
Procedural pain 41.77 41.03 9 187723 33351 90407364
Food allergy 41.18 41.03 3 187729 25475 90415240
Seronegative arthritis 41.17 41.03 106 187626 18128 90422587

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
Pain 715.60 30.34 453 6246 244395 42370241
Arthralgia 636.83 30.34 395 6304 204843 42409793
Joint swelling 515.07 30.34 238 6461 67784 42546852
Drug ineffective 368.29 30.34 468 6231 629729 41984907
Loss of personal independence in daily activities 224.60 30.34 123 6576 49693 42564943
Injection site pruritus 163.95 30.34 60 6639 9345 42605291
Product use in unapproved indication 143.59 30.34 160 6539 184296 42430340
Injection site swelling 132.83 30.34 61 6638 16912 42597724
Injection site rash 128.29 30.34 44 6655 5668 42608968
Condition aggravated 127.31 30.34 179 6520 260575 42354061
Injection site erythema 116.84 30.34 59 6640 20136 42594500
Mycobacterium chelonae infection 69.20 30.34 19 6680 1159 42613477
Rhinorrhoea 65.73 30.34 48 6651 31746 42582890
Gait disturbance 64.22 30.34 78 6621 97922 42516714
Rheumatoid arthritis 49.61 30.34 46 6653 42394 42572242
Death 46.41 30.34 9 6690 471176 42143460
Injection site bruising 45.12 30.34 26 6673 11499 42603137
Injection site reaction 44.94 30.34 29 6670 15692 42598944
Swollen joint count increased 43.93 30.34 10 6689 281 42614355
Product dose omission in error 41.36 30.34 22 6677 8332 42606304
Musculoskeletal stiffness 41.12 30.34 48 6651 57717 42556919
Acute kidney injury 40.71 30.34 5 6694 367332 42247304
Therapeutic response decreased 37.34 30.34 37 6662 36975 42577661
White blood cell count decreased 37.05 30.34 64 6635 110332 42504304
Injection site pain 34.59 30.34 44 6655 57754 42556882
Myelodysplastic syndrome unclassifiable 33.93 30.34 7 6692 122 42614514
Pain in extremity 33.07 30.34 73 6626 150531 42464105
Therapeutic response shortened 31.53 30.34 22 6677 13532 42601104

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
Joint swelling 1911.29 45.03 2692 150917 440153 109995537
Pemphigus 1243.03 45.03 1510 152099 213060 110222630
Anti-cyclic citrullinated peptide antibody positive 1239.76 45.03 1392 152217 180592 110255098
Hand deformity 1180.91 45.03 1485 152124 217021 110218669
Pericarditis 1169.67 45.03 1480 152129 217634 110218056
Systemic lupus erythematosus 1144.93 45.03 1580 152029 252758 110182932
Arthralgia 1126.20 45.03 2975 150634 776657 109659033
Glossodynia 1118.18 45.03 1457 152152 220547 110215143
Duodenal ulcer perforation 1014.88 45.03 1242 152367 176458 110259232
Wound 1012.56 45.03 1428 152181 233009 110202681
Helicobacter infection 894.23 45.03 1180 152429 180697 110254993
Pain 878.77 45.03 3112 150497 951843 109483847
Rheumatoid factor positive 873.92 45.03 994 152615 130646 110305044
Arthropathy 856.60 45.03 1476 152133 286046 110149644
Synovitis 830.84 45.03 1418 152191 272674 110163016
Hepatic enzyme increased 825.25 45.03 1545 152064 319347 110116343
Acute kidney injury 781.82 45.03 22 153587 635408 109800282
Alopecia 774.92 45.03 1621 151988 363132 110072558
Discomfort 768.75 45.03 1198 152411 213509 110222181
Rheumatic fever 743.97 45.03 884 152725 121695 110313995
Abdominal discomfort 703.78 45.03 1633 151976 392225 110043465
Blood cholesterol increased 672.43 45.03 1039 152570 183746 110251944
Blister 656.87 45.03 1152 152457 226224 110209466
Type 2 diabetes mellitus 652.56 45.03 1002 152607 176230 110259460
Toxicity to various agents 644.46 45.03 4 153605 480551 109955139
Liver injury 642.52 45.03 912 152697 149501 110286189
Swollen joint count increased 628.03 45.03 674 152935 82987 110352703
Maternal exposure during pregnancy 626.11 45.03 1204 152405 253679 110182011
Swelling 623.07 45.03 1452 152157 349589 110086101
Drug interaction 612.49 45.03 18 153591 500165 109935525
Anaemia 578.23 45.03 49 153560 547037 109888653
Hypotension 576.05 45.03 39 153570 523810 109911880
Mobility decreased 543.57 45.03 1089 152520 236333 110199357
Death 529.87 45.03 157 153452 698712 109736978
Contraindicated product administered 525.01 45.03 1102 152507 247165 110188525
Folliculitis 518.82 45.03 876 152733 166777 110268913
Muscle injury 518.04 45.03 796 152813 140011 110295679
Fibromyalgia 516.99 45.03 884 152725 170025 110265665
Hip arthroplasty 513.85 45.03 502 153107 55311 110380379
Psoriatic arthropathy 512.14 45.03 953 152656 195808 110239882
Injury 502.51 45.03 891 152718 176374 110259316
Irritable bowel syndrome 489.61 45.03 844 152765 163371 110272319
Facet joint syndrome 475.05 45.03 628 152981 96200 110339490
Condition aggravated 466.86 45.03 2137 151472 732699 109702991
Loss of personal independence in daily activities 465.63 45.03 785 152824 149235 110286455
Knee arthroplasty 457.30 45.03 506 153103 64442 110371248
Infusion related reaction 434.06 45.03 1338 152271 379824 110055866
Breast cancer stage III 433.40 45.03 542 153067 78575 110357115
Hypersensitivity 426.94 45.03 1382 152227 402616 110033074
Treatment failure 422.50 45.03 1082 152527 276152 110159538
Lip dry 414.19 45.03 598 153011 99485 110336205
Bursitis 410.03 45.03 685 152924 129233 110306457
Live birth 406.39 45.03 492 153117 68992 110366698
Deep vein thrombosis postoperative 398.69 45.03 451 153158 58840 110376850
Hypercholesterolaemia 392.42 45.03 554 153055 90283 110345407
Impaired healing 386.70 45.03 848 152761 195869 110239821
Musculoskeletal stiffness 385.60 45.03 1052 152557 278770 110156920
Gait inability 381.88 45.03 682 152927 135694 110299996
Drug intolerance 376.02 45.03 1330 152279 405182 110030508
Autoimmune disorder 373.75 45.03 458 153151 65025 110370665
Grip strength decreased 367.29 45.03 503 153106 79671 110356019
Peripheral venous disease 363.32 45.03 513 153096 83604 110352086
Therapeutic product effect decreased 351.10 45.03 933 152676 243383 110192307
Constipation 349.40 45.03 43 153566 357743 110077947
Dehydration 342.12 45.03 10 153599 279501 110156189
Joint range of motion decreased 335.61 45.03 605 153004 121227 110314463
Stomatitis 329.34 45.03 972 152637 269270 110166420
Sepsis 320.46 45.03 39 153570 327307 110108383
Wound infection 319.63 45.03 520 153089 95945 110339745
Lower respiratory tract infection 319.02 45.03 898 152711 242208 110193482
Osteoarthritis 315.34 45.03 748 152861 181875 110253815
Somnolence 312.99 45.03 27 153582 297422 110138268
Ill-defined disorder 296.71 45.03 666 152943 156187 110279503
Neutropenia 294.96 45.03 78 153531 374542 110061148
Disease progression 294.08 45.03 10 153599 244024 110191666
Sleep disorder due to general medical condition, insomnia type 286.35 45.03 521 153088 105122 110330568
Blepharospasm 280.17 45.03 363 153246 54488 110381202
Night sweats 276.24 45.03 589 153020 133394 110302296
Lower limb fracture 275.58 45.03 425 153184 74923 110360767
Product use issue 273.67 45.03 1003 152606 310692 110124998
Inflammation 272.51 45.03 733 152876 192505 110243185
Injection site pruritus 269.30 45.03 344 153265 50914 110384776
C-reactive protein abnormal 266.05 45.03 569 153040 129126 110306564
Haemoglobin decreased 266.02 45.03 21 153588 248706 110186984
Renal failure 263.81 45.03 12 153597 226562 110209128
Seizure 263.27 45.03 10 153599 221175 110214515
Cough 257.10 45.03 162 153447 461479 109974211
Thrombocytopenia 253.92 45.03 84 153525 348801 110086889
Product use in unapproved indication 247.04 45.03 1251 152358 446126 109989564
Dislocation of vertebra 246.55 45.03 304 153305 43417 110392273
Lupus vulgaris 245.41 45.03 268 153341 33615 110402075
Atrial fibrillation 243.88 45.03 20 153589 229622 110206068
Adjustment disorder with depressed mood 242.44 45.03 302 153307 43581 110392109
Syncope 241.59 45.03 9 153600 202527 110233163
Blood pressure increased 240.44 45.03 36 153573 258337 110177353
Pulmonary embolism 238.34 45.03 15 153594 214459 110221231
Blood creatinine increased 237.92 45.03 3 153606 182886 110252804
Hypoaesthesia 237.24 45.03 964 152645 313259 110122431
Obesity 236.75 45.03 501 153108 112850 110322840
Respiratory failure 236.51 45.03 16 153593 215316 110220374
General physical health deterioration 233.91 45.03 1188 152421 424107 110011583
Cardiac arrest 233.80 45.03 9 153600 196744 110238946
Dry mouth 232.88 45.03 708 152901 199240 110236450
Injection site rash 231.26 45.03 219 153390 23200 110412490
Nail disorder 227.76 45.03 338 153271 57597 110378093
Retinitis 226.00 45.03 251 153358 32076 110403614
Fall 215.83 45.03 315 153294 603167 109832523
Exostosis 211.43 45.03 289 153320 45667 110390023
Prescribed overdose 211.29 45.03 411 153198 87170 110348520
Renal impairment 209.92 45.03 13 153596 188432 110247258
Onychomadesis 209.85 45.03 287 153322 45376 110390314
Back injury 207.47 45.03 291 153318 47108 110388582
Cardiac failure 205.88 45.03 14 153595 187612 110248078
C-reactive protein 202.63 45.03 230 153379 30101 110405589
Platelet count decreased 197.15 45.03 40 153569 230403 110205287
Sciatica 197.13 45.03 412 153197 91987 110343703
Myocardial infarction 195.19 45.03 20 153589 192063 110243627
Alanine aminotransferase increased 195.13 45.03 16 153593 183757 110251933
Adverse event 194.60 45.03 452 153157 108357 110327333
Laryngitis 189.54 45.03 263 153346 42148 110393542
Bradycardia 188.66 45.03 6 153603 155511 110280179
Aspartate aminotransferase increased 187.71 45.03 8 153601 159928 110275762
Urticaria 186.03 45.03 906 152703 317951 110117739
Gastrointestinal haemorrhage 185.62 45.03 11 153598 165507 110270183
X-ray abnormal 184.94 45.03 246 153363 37871 110397819
Gastrointestinal disorder 184.68 45.03 745 152864 241207 110194483
Pleural effusion 184.53 45.03 17 153592 177692 110257998
Tremor 184.00 45.03 30 153579 202202 110233488
Lupus-like syndrome 183.85 45.03 254 153355 40538 110395152
Bone erosion 178.64 45.03 268 153341 46103 110389587
Pancytopenia 175.98 45.03 38 153571 209575 110226115
Injection site erythema 175.90 45.03 398 153211 93778 110341912
Injection site reaction 174.87 45.03 384 153225 88686 110347004
Epilepsy 174.53 45.03 412 153197 99797 110335893
Dyspnoea 174.12 45.03 869 152740 1106003 109329687
Hyperkalaemia 173.31 45.03 3 153606 135793 110299897
Cerebrovascular accident 171.56 45.03 24 153585 181260 110254430
Oxygen saturation decreased 171.39 45.03 12 153597 156970 110278720
Lung disorder 171.19 45.03 595 153014 179452 110256238
Hypokalaemia 170.69 45.03 25 153584 182423 110253267
Sleep disorder 169.79 45.03 634 152975 198010 110237680
Hepatic cirrhosis 165.11 45.03 319 153290 67307 110368383
Loss of consciousness 163.96 45.03 36 153573 196270 110239420
Hyperhidrosis 163.38 45.03 31 153578 187267 110248423
Palpitations 163.26 45.03 16 153593 159196 110276494
Cardiac failure congestive 160.71 45.03 13 153596 150987 110284703
Chest discomfort 159.93 45.03 25 153584 173823 110261867
Exposure during pregnancy 158.92 45.03 553 153056 166871 110268819
Contusion 155.13 45.03 689 152920 232672 110203018
Multiple organ dysfunction syndrome 153.60 45.03 16 153593 151694 110283996
Back pain 152.78 45.03 174 153435 370822 110064868
Walking aid user 152.19 45.03 181 153428 24894 110410796
Erythema 151.78 45.03 110 153499 291337 110144353
Heart rate increased 151.38 45.03 13 153596 143821 110291869
Pyrexia 151.18 45.03 688 152921 897577 109538113
Migraine 148.47 45.03 550 153059 171102 110264588
Neuropathy peripheral 147.47 45.03 34 153575 179243 110256447
Off label use 147.36 45.03 1355 152254 1498830 108936860
Joint stiffness 147.12 45.03 303 153306 66940 110368750
Hypoxia 147.09 45.03 8 153601 129507 110306183
Intentional product use issue 143.51 45.03 703 152906 247203 110188487
Abdominal pain upper 142.06 45.03 900 152709 348211 110087479
Wheezing 141.53 45.03 715 152894 254515 110181175
Dysphagia 141.49 45.03 22 153587 153578 110282112
Deep vein thrombosis 140.99 45.03 15 153594 139872 110295818
Nasopharyngitis 140.79 45.03 984 152625 393377 110042313
Musculoskeletal pain 139.16 45.03 563 153046 182460 110253230
Road traffic accident 139.01 45.03 395 153214 107003 110328687
Cardio-respiratory arrest 138.62 45.03 5 153604 115831 110319859
Taste disorder 136.47 45.03 289 153320 65098 110370592
Nausea 134.61 45.03 1086 152523 1234604 109201086
Anti-cyclic citrullinated peptide antibody 134.39 45.03 152 153457 19812 110415878
Peripheral swelling 134.32 45.03 991 152618 403043 110032647
Urinary tract infection 133.27 45.03 154 153455 326128 110109562
Joint dislocation 130.83 45.03 197 153412 33993 110401697
Breast cancer stage II 130.24 45.03 175 153434 27200 110408490
Gait disturbance 130.23 45.03 744 152865 277464 110158226
Injection site swelling 128.84 45.03 273 153336 61517 110374173
Ulcer haemorrhage 127.33 45.03 157 153452 22414 110413276
Chills 126.62 45.03 53 153556 190527 110245163
Onychomycosis 126.60 45.03 207 153402 38324 110397366
Pulmonary fibrosis 125.97 45.03 369 153240 101673 110334017
Finger deformity 125.67 45.03 190 153419 32902 110402788
Metabolic acidosis 124.11 45.03 3 153606 99741 110335949
Epistaxis 123.96 45.03 17 153592 130355 110305335
Angioedema 122.42 45.03 3 153606 98497 110337193
Vision blurred 122.26 45.03 17 153592 129005 110306685
Product label confusion 121.95 45.03 154 153455 22523 110413167
Septic shock 121.62 45.03 34 153575 157494 110278196
Overdose 120.72 45.03 89 153520 233705 110201985
Foot deformity 119.94 45.03 230 153379 48250 110387440
Pulmonary oedema 118.22 45.03 5 153604 100654 110335036
Rash 118.18 45.03 1695 151914 819269 109616421
Diarrhoea 116.99 45.03 1017 152592 1138488 109297202
Blood pressure decreased 116.86 45.03 12 153597 115079 110320611
Adverse drug reaction 116.50 45.03 367 153242 105192 110330498
Hallucination 112.93 45.03 7 153602 101425 110334265
Flushing 111.49 45.03 9 153600 104727 110330963
Blood glucose increased 111.23 45.03 24 153585 132472 110303218
Colitis 111.17 45.03 8 153601 102315 110333375
Dyspnoea exertional 110.61 45.03 9 153600 104051 110331639
Ear infection 110.38 45.03 259 153350 62473 110373217
Oedema 109.96 45.03 579 153030 209397 110226293
Myalgia 109.30 45.03 89 153520 222292 110213398
Disability 108.40 45.03 169 153440 30054 110405636
Cognitive disorder 107.49 45.03 3 153606 87508 110348182
Dyspepsia 107.25 45.03 537 153072 190428 110245262
Memory impairment 107.23 45.03 549 153060 196395 110239295
Myelosuppression 106.59 45.03 6 153603 94334 110341356
Electrocardiogram QT prolonged 106.50 45.03 13 153596 108947 110326743
Lethargy 105.57 45.03 6 153603 93570 110342120
Ascites 104.56 45.03 6 153603 92802 110342888
Acute myocardial infarction 102.43 45.03 3 153606 83774 110351916
Hepatic function abnormal 99.90 45.03 6 153603 89289 110346401
Feeling abnormal 99.66 45.03 64 153545 180647 110255043
Haematochezia 98.88 45.03 20 153589 115504 110320186
Drug ineffective 98.29 45.03 2783 150826 1517757 108917933
Weight decreased 97.38 45.03 329 153280 467728 109967962
Haemorrhage 96.64 45.03 16 153593 106676 110329014
Chronic obstructive pulmonary disease 95.32 45.03 18 153591 109140 110326550
Blood pressure systolic increased 94.63 45.03 5 153604 82986 110352704
Prescribed underdose 94.56 45.03 250 153359 64924 110370766
Pneumonitis 92.63 45.03 3 153606 76528 110359162
Tachycardia 92.48 45.03 107 153502 226538 110209152
Liver function test increased 92.38 45.03 302 153307 88246 110347444
Pneumonia aspiration 92.29 45.03 5 153604 81228 110354462
Balance disorder 92.15 45.03 24 153585 116536 110319154
Diabetes mellitus 92.05 45.03 14 153595 99367 110336323
Drug hypersensitivity 92.05 45.03 1000 152609 453090 109982600
Haematuria 91.60 45.03 6 153603 82999 110352691
Seronegative arthritis 91.55 45.03 102 153507 13075 110422615
Hyperglycaemia 91.45 45.03 7 153602 85083 110350607
Productive cough 89.48 45.03 24 153585 114281 110321409
Wrong technique in product usage process 88.96 45.03 9 153600 87339 110348351
Chronic kidney disease 88.90 45.03 4 153605 76287 110359403
Heart rate decreased 88.40 45.03 7 153602 82749 110352941
Pregnancy 87.84 45.03 209 153400 50858 110384832
Abdominal pain 87.23 45.03 391 153218 512598 109923092
Rash maculo-papular 86.13 45.03 4 153605 74218 110361472
Blood bilirubin increased 85.31 45.03 5 153604 75967 110359723
Product quality issue 84.60 45.03 268 153341 77031 110358659
Pneumonia 84.34 45.03 795 152814 875919 109559771
C-reactive protein increased 83.76 45.03 554 153055 217365 110218325
Mental status changes 82.55 45.03 6 153603 76116 110359574
Respiratory distress 82.31 45.03 3 153606 68871 110366819
Coeliac disease 82.27 45.03 184 153425 43003 110392687
Stress 80.82 45.03 23 153586 105325 110330365
Red blood cell sedimentation rate increased 80.74 45.03 266 153343 78036 110357654
Haemoptysis 79.21 45.03 5 153604 71349 110364341
Overlap syndrome 78.73 45.03 79 153530 8980 110426710
Subcutaneous drug absorption impaired 78.25 45.03 73 153536 7586 110428104
Blood pressure fluctuation 78.08 45.03 7 153602 74817 110360873
Interstitial lung disease 75.93 45.03 50 153559 139284 110296406
Sinusitis 75.43 45.03 685 152924 296003 110139687
Haematocrit decreased 75.33 45.03 4 153605 66113 110369577
Hepatotoxicity 74.95 45.03 3 153606 63397 110372293
Cerebral haemorrhage 73.80 45.03 4 153605 64964 110370726
Infection 73.06 45.03 797 152812 361403 110074287
Hepatic failure 72.90 45.03 6 153603 68733 110366957
Thrombosis 72.51 45.03 30 153579 108632 110327058
Dysgeusia 71.82 45.03 7 153602 69978 110365712
Disease recurrence 71.44 45.03 3 153606 60781 110374909
Haematemesis 69.19 45.03 3 153606 59105 110376585
Aphasia 69.05 45.03 3 153606 58994 110376696
Respiratory arrest 68.11 45.03 3 153606 58296 110377394
Liver function test abnormal 67.94 45.03 8 153601 68942 110366748
Melaena 67.69 45.03 8 153601 68749 110366941
Speech disorder 66.34 45.03 5 153604 61564 110374126
Pallor 65.66 45.03 3 153606 56464 110379226
Neutrophil count decreased 65.09 45.03 44 153565 120897 110314793
Bone marrow failure 64.37 45.03 4 153605 57844 110377846
Agranulocytosis 63.85 45.03 6 153603 61754 110373936
Maternal exposure timing unspecified 63.83 45.03 109 153500 20904 110414786
Influenza 63.56 45.03 85 153524 169016 110266674
Vomiting 63.22 45.03 888 152721 909787 109525903
Drug reaction with eosinophilia and systemic symptoms 62.83 45.03 18 153591 82077 110353613
Cholestasis 62.31 45.03 8 153601 64510 110371180
Dysuria 61.87 45.03 6 153603 60225 110375465
Hypophagia 60.53 45.03 3 153606 52623 110383067
Porphyria acute 60.48 45.03 100 153509 18680 110417010
Weight increased 59.99 45.03 866 152743 418778 110016912
Haematoma 59.61 45.03 6 153603 58470 110377220
Angina pectoris 59.50 45.03 8 153601 62287 110373403
Infusion site reaction 59.45 45.03 96 153513 17586 110418104
Restlessness 59.42 45.03 5 153604 56254 110379436
Pancreatitis acute 59.37 45.03 7 153602 60267 110375423
Eczema 58.86 45.03 14 153595 72279 110363411
Adverse reaction 58.52 45.03 128 153481 29466 110406224
Vertigo 57.94 45.03 24 153585 86846 110348844
Multiple sclerosis relapse 57.36 45.03 3 153606 50237 110385453
Red blood cell count decreased 57.28 45.03 11 153598 65912 110369778
Normal newborn 56.78 45.03 106 153503 21790 110413900
Cataract 56.26 45.03 20 153589 79465 110356225
Gastritis 56.09 45.03 5 153604 53694 110381996
Drug eruption 56.04 45.03 5 153604 53654 110382036
Altered state of consciousness 56.00 45.03 7 153602 57619 110378071
Shock 55.95 45.03 5 153604 53583 110382107
Dyskinesia 55.94 45.03 4 153605 51442 110384248
Liver disorder 54.86 45.03 362 153247 141881 110293809
Candida infection 54.39 45.03 3 153606 48006 110387684
Cardiac disorder 54.33 45.03 19 153590 76261 110359429
Upper gastrointestinal haemorrhage 54.17 45.03 4 153605 50092 110385598
Full blood count abnormal 54.01 45.03 7 153602 56045 110379645
Intentional product misuse 53.92 45.03 63 153546 132841 110302849
Amnesia 53.32 45.03 288 153321 105120 110330570
Pericardial effusion 53.12 45.03 8 153601 57209 110378481
Lymphadenopathy 52.69 45.03 12 153597 63823 110371867
Drug tolerance decreased 52.07 45.03 117 153492 27423 110408267
Therapy non-responder 51.68 45.03 385 153224 156922 110278768
Osteonecrosis of jaw 51.45 45.03 4 153605 48013 110387677
Confusional state 51.18 45.03 925 152684 467755 109967935
Irritability 51.18 45.03 4 153605 47805 110387885
Osteoporosis 50.25 45.03 247 153362 86905 110348785
Hypertension 48.96 45.03 987 152622 509097 109926593
Drug dependence 48.80 45.03 6 153603 50014 110385676
Cellulitis 48.73 45.03 62 153547 125954 110309736
Swollen tongue 48.53 45.03 12 153597 60350 110375340
Arrhythmia 48.41 45.03 18 153591 69557 110366133
Swollen joint count 48.38 45.03 60 153549 8614 110427076
Product prescribing error 48.07 45.03 7 153602 51324 110384366
Cystitis 47.80 45.03 16 153593 66020 110369670
Dysphonia 47.46 45.03 23 153586 75906 110359784
Pustular psoriasis 47.29 45.03 75 153534 13530 110422160
Transient ischaemic attack 47.20 45.03 15 153594 63967 110371723
Drug-induced liver injury 47.17 45.03 307 153302 119760 110315930
Urinary incontinence 46.98 45.03 6 153603 48581 110387109
Skin lesion 46.18 45.03 8 153601 51623 110384067
Therapy interrupted 46.18 45.03 7 153602 49815 110385875
Spinal fusion surgery 45.81 45.03 60 153549 9096 110426594
Anaphylactic reaction 45.49 45.03 55 153554 114245 110321445
Ischaemic stroke 45.47 45.03 3 153606 41260 110394430

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC14 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000190478 Interleukin 6 Receptor Antagonists
FDA EPC N0000190480 Interleukin-6 Receptor Antagonist
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs
anakinrabasiliximabbimekizumabbrodalumabcanakinumabdaclizumabguselkumabixekizumabmirikizumabrilonaceptrisankizumabsatralizumab show all 18 →

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

DiseaseRelationSNOMED_IDDOID
Rheumatoid arthritis indication 69896004 DOID:7148
Bacterial infectious disease contraindication 87628006




🐶 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-6 receptor subunit alpha Cytokine ANTIBODY BINDING Kd 11.10 IUPHAR DRUG LABEL

External reference:

IDSource
NU90V55F8I UNII
4036706 VANDF
C3885145 UMLSCUI
CHEBI:753668 CHEBI
CHEMBL2108730 ChEMBL_ID
DB11767 DRUGBANK_ID
D10161 KEGG_DRUG
9476 INN_ID
C000592401 MESH_SUPPLEMENTAL_RECORD_UI
7999 IUPHAR_LIGAND_ID
735231009 SNOMEDCT_US
763522001 SNOMEDCT_US
257686 MMSL
32766 MMSL
d08592 MMSL
017137 NDDF
1923319 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
KEVZARA HUMAN PRESCRIPTION DRUG LABEL 1 0024-5908 INJECTION, SOLUTION 150 mg SUBCUTANEOUS BLA 31 sections
KEVZARA HUMAN PRESCRIPTION DRUG LABEL 1 0024-5910 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
KEVZARA HUMAN PRESCRIPTION DRUG LABEL 1 0024-5920 INJECTION, SOLUTION 150 mg SUBCUTANEOUS BLA 31 sections
KEVZARA HUMAN PRESCRIPTION DRUG LABEL 1 0024-5922 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections