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

Stem definitionDrug idCAS RN
humanized origin 5223 637334-45-3

Description:

MoleculeDescription

Synonyms:

  • ocrelizumab
  • PR070769
  • ocrevus
The precise mechanism by which ocrelizumab exerts its therapeutic effects in multiple sclerosis is unknown, but is presumed to involve binding to CD20, a cell surface antigen present on pre-B and mature B lymphocytes. Following cell surface binding to B lymphocytes, ocrelizumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
3.29 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Aug. 1, 2018 EMA Roche Registration GmbH
March 28, 2017 FDA GENENTECH INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
COVID-19 6847.00 15.34 2759 45599 166084 90414005
Multiple sclerosis relapse 1060.81 15.34 530 47828 51775 90528314
Throat irritation 1000.97 15.34 498 47860 48197 90531892
Urinary tract infection 881.22 15.34 943 47415 304689 90275400
Multiple sclerosis 822.91 15.34 366 47992 27474 90552615
Maternal exposure before pregnancy 822.90 15.34 285 48073 10928 90569161
SARS-CoV-2 test positive 599.26 15.34 225 48133 10903 90569186
Herpes zoster 555.91 15.34 436 47922 94208 90485881
Infusion related reaction 538.01 15.34 866 47492 415914 90164175
JC polyomavirus test positive 509.01 15.34 130 48228 1672 90578417
Oral herpes 446.37 15.34 257 48101 33267 90546822
COVID-19 pneumonia 403.25 15.34 196 48162 17981 90562108
B-lymphocyte count decreased 400.36 15.34 103 48255 1366 90578723
Coronavirus infection 331.78 15.34 121 48237 5394 90574695
Breast cancer 316.13 15.34 248 48110 53513 90526576
No adverse event 284.94 15.34 258 48100 67724 90512365
Influenza 284.77 15.34 361 47997 138903 90441186
Ear pruritus 238.64 15.34 101 48257 6702 90573387
Blood immunoglobulin M decreased 209.34 15.34 61 48297 1316 90578773
Blood immunoglobulin G decreased 177.65 15.34 68 48290 3470 90576619
Muscle spasticity 176.03 15.34 148 48210 35174 90544915
SARS-CoV-2 antibody test negative 170.31 15.34 39 48319 304 90579785
Oropharyngeal pain 166.83 15.34 253 48105 114934 90465155
Lymphopenia 166.57 15.34 120 48238 22761 90557328
Gait disturbance 165.71 15.34 403 47955 260093 90319996
Joint swelling 160.77 15.34 36 48322 503264 90076825
Rheumatoid arthritis 157.23 15.34 9 48349 362605 90217484
Systemic lupus erythematosus 153.84 15.34 10 48348 361886 90218203
Optic neuritis 152.73 15.34 83 48275 9595 90570494
Fatigue 151.75 15.34 1092 47266 1152931 89427158
Glossodynia 149.30 15.34 5 48353 321774 90258315
Cystitis noninfective 141.18 15.34 45 48313 1324 90578765
Throat tightness 139.66 15.34 120 48238 29364 90550725
Drug ineffective 138.88 15.34 337 48021 1383961 89196128
Magnetic resonance imaging abnormal 136.56 15.34 56 48302 3430 90576659
Product use issue 134.82 15.34 11 48347 329908 90250181
Toxicity to various agents 131.70 15.34 5 48353 287841 90292248
Nasopharyngitis 131.55 15.34 496 47862 406608 90173481
Herpes virus infection 130.11 15.34 65 48293 6319 90573770
Condition aggravated 121.25 15.34 85 48273 595460 89984629
Relapsing multiple sclerosis 119.35 15.34 27 48331 198 90579891
Abortion spontaneous 118.14 15.34 145 48213 53911 90526178
Genital herpes 110.99 15.34 42 48316 2076 90578013
Arthropathy 109.49 15.34 30 48328 366212 90213877
Balance disorder 107.63 15.34 189 48169 96891 90483198
Abdominal discomfort 106.90 15.34 61 48297 477267 90102822
Pericarditis 105.03 15.34 11 48347 270140 90309949
Invasive ductal breast carcinoma 104.17 15.34 60 48298 7758 90572331
Hepatic enzyme increased 101.55 15.34 33 48325 360703 90219386
Product use in unapproved indication 99.64 15.34 28 48330 336208 90243881
Neuralgia 98.80 15.34 102 48256 31398 90548691
Muscular weakness 98.12 15.34 287 48071 206379 90373710
Wound 98.01 15.34 21 48337 302959 90277130
Human papilloma virus test positive 97.11 15.34 29 48329 683 90579406
Cystitis 95.77 15.34 146 48212 66572 90513517
Swelling 94.61 15.34 53 48305 419005 90161084
Helicobacter infection 94.23 15.34 7 48351 226843 90353246
Agranulocytosis 93.33 15.34 104 48254 34898 90545191
Urinary incontinence 92.33 15.34 107 48251 37459 90542630
Exposure during pregnancy 91.92 15.34 10 48348 238400 90341689
Hypogammaglobulinaemia 89.37 15.34 61 48297 10613 90569476
Lymphocyte count decreased 88.11 15.34 101 48257 34949 90545140
Acute kidney injury 87.23 15.34 31 48327 320356 90259733
Psoriatic arthropathy 86.97 15.34 10 48348 228325 90351764
General physical health deterioration 85.95 15.34 41 48317 355074 90225015
Treatment failure 81.73 15.34 30 48328 303898 90276191
Demyelination 81.46 15.34 52 48306 8088 90572001
Expanded disability status scale score increased 80.55 15.34 26 48332 797 90579292
Immunoglobulins decreased 77.17 15.34 30 48328 1596 90578493
Product dose omission issue 76.41 15.34 30 48328 291657 90288432
Drug intolerance 76.08 15.34 76 48282 447515 90132574
Hemiparesis 75.48 15.34 89 48269 31730 90548359
Diarrhoea 75.17 15.34 254 48104 938936 89641153
Injury 74.26 15.34 9 48349 197340 90382749
Cough 73.86 15.34 390 47968 368572 90211517
Folliculitis 72.91 15.34 11 48347 204342 90375747
Impaired healing 72.21 15.34 18 48340 234181 90345908
Liver injury 71.58 15.34 5 48353 170562 90409527
Fibromyalgia 71.57 15.34 12 48346 206257 90373832
Maternal exposure timing unspecified 70.86 15.34 73 48285 22410 90557679
Therapeutic product effect decreased 70.35 15.34 30 48328 277541 90302548
Hypoaesthesia 69.07 15.34 341 48017 313869 90266220
Vitamin D deficiency 68.38 15.34 64 48294 17492 90562597
Papilloma viral infection 67.67 15.34 28 48330 1754 90578335
Sensory disturbance 65.51 15.34 59 48299 15354 90564735
Vaginal infection 65.42 15.34 46 48312 8394 90571695
Stomatitis 64.51 15.34 33 48325 274665 90305424
Blister 63.92 15.34 28 48330 254970 90325119
Ataxia 63.14 15.34 62 48296 17980 90562109
Colitis 62.29 15.34 124 48234 69818 90510271
Irritable bowel syndrome 61.93 15.34 17 48341 207431 90372658
Flushing 61.66 15.34 142 48216 88349 90491740
Peroneal nerve palsy 60.72 15.34 38 48320 5710 90574379
Abdominal pain 59.76 15.34 74 48284 395647 90184442
Therapeutic product effect incomplete 59.57 15.34 15 48343 193881 90386208
Malignant melanoma 59.17 15.34 51 48307 12525 90567564
Illness 58.74 15.34 133 48225 81836 90498253
Vomiting 58.46 15.34 220 48138 788073 89792016
West Nile viral infection 57.01 15.34 18 48340 513 90579576
Discomfort 55.92 15.34 39 48319 274296 90305793
Micturition urgency 55.80 15.34 47 48311 11186 90568903
B-lymphocyte count increased 55.41 15.34 13 48345 114 90579975
Magnetic resonance imaging head abnormal 54.98 15.34 27 48331 2529 90577560
Anaemia 54.29 15.34 65 48293 352737 90227352
Asthenia 54.19 15.34 477 47881 533274 90046815
Oedema 53.43 15.34 20 48338 200275 90379814
Wheezing 52.41 15.34 31 48327 238049 90342040
Injection site pain 52.29 15.34 14 48344 173685 90406404
Decreased appetite 52.18 15.34 75 48283 376465 90203624
Bursitis 52.08 15.34 5 48353 131649 90448440
Pancytopenia 52.02 15.34 3 48355 120260 90459829
Influenza like illness 51.43 15.34 125 48233 80486 90499603
Type 2 diabetes mellitus 51.43 15.34 22 48336 203222 90376867
Suspected COVID-19 50.79 15.34 26 48332 2660 90577429
T-lymphocyte count decreased 50.69 15.34 15 48343 342 90579747
Decreased vibratory sense 50.36 15.34 15 48343 350 90579739
B-lymphocyte abnormalities 50.22 15.34 14 48344 256 90579833
Paraesthesia 49.62 15.34 264 48094 250062 90330027
Drug interaction 49.19 15.34 45 48313 276408 90303681
Immunosuppression 48.92 15.34 45 48313 12032 90568057
Pneumonia 48.58 15.34 537 47821 637522 89942567
Neurogenic bladder 48.39 15.34 28 48330 3650 90576439
Thrombocytopenia 47.62 15.34 26 48332 208699 90371390
Peripheral swelling 47.34 15.34 93 48265 413013 90167076
Overdose 46.92 15.34 13 48345 157696 90422393
Oral pruritus 45.70 15.34 25 48333 2926 90577163
Headache 44.95 15.34 677 47681 862069 89718020
Organising pneumonia 44.51 15.34 35 48323 7562 90572527
Oedema peripheral 43.54 15.34 44 48314 257871 90322218
Bacterial vaginosis 43.20 15.34 20 48338 1643 90578446
Encephalitis enteroviral 43.00 15.34 10 48348 84 90580005
Pulmonary fibrosis 42.74 15.34 4 48354 107499 90472590
Joint range of motion decreased 42.62 15.34 10 48348 135633 90444456
Central nervous system lesion 42.58 15.34 41 48317 11605 90568484
Arthralgia 42.42 15.34 243 48115 778279 89801810
Drug hypersensitivity 42.20 15.34 118 48240 463491 90116598
Urosepsis 41.68 15.34 54 48304 21178 90558911
Pyelonephritis 41.51 15.34 54 48304 21262 90558827
Cognitive disorder 41.50 15.34 105 48253 69302 90510787
T-lymphocyte count increased 41.39 15.34 12 48346 254 90579835
Upper respiratory tract infection 41.01 15.34 156 48202 128162 90451927
Clumsiness 40.14 15.34 22 48336 2585 90577504
Fungal infection 39.63 15.34 77 48281 42584 90537505
Anogenital warts 39.26 15.34 14 48344 584 90579505
Confusional state 39.21 15.34 93 48265 386112 90193977
Progressive multifocal leukoencephalopathy 39.15 15.34 45 48313 15610 90564479
Immunisation reaction 38.82 15.34 15 48343 785 90579304
Pharyngeal disorder 38.36 15.34 21 48337 2462 90577627
Musculoskeletal pain 38.10 15.34 22 48336 171229 90408860
Selective IgG subclass deficiency 37.44 15.34 7 48351 16 90580073
Varicella virus test positive 37.41 15.34 10 48348 155 90579934
Blood creatinine increased 37.22 15.34 5 48353 101381 90478708
Lip dry 37.01 15.34 5 48353 100950 90479139
Limb discomfort 36.96 15.34 70 48288 37990 90542099
Liver disorder 36.07 15.34 10 48348 121259 90458830
Inflammation 35.57 15.34 26 48332 178566 90401523
Hospitalisation 35.51 15.34 12 48346 128088 90452001
CD4 lymphocytes decreased 35.25 15.34 17 48341 1530 90578559
Hypokalaemia 35.12 15.34 13 48345 131103 90448986
CD4 lymphocytes increased 35.07 15.34 10 48348 199 90579890
Nausea 34.93 15.34 402 47956 1109914 89470175
Hyponatraemia 34.51 15.34 14 48344 133524 90446565
Pharyngeal swelling 34.47 15.34 34 48324 9910 90570179
Intraductal proliferative breast lesion 34.41 15.34 22 48336 3431 90576658
Gastrointestinal haemorrhage 34.22 15.34 4 48354 90244 90489845
Infection susceptibility increased 34.21 15.34 23 48335 3903 90576186
Therapeutic response shortened 34.14 15.34 51 48307 22828 90557261
Gastrointestinal disorder 33.72 15.34 53 48305 256634 90323455
Appendicitis 33.66 15.34 34 48324 10197 90569892
Cervical dysplasia 33.64 15.34 23 48335 4011 90576078
Gastrointestinal infection 33.40 15.34 35 48323 10955 90569134
Knee arthroplasty 33.32 15.34 3 48355 83179 90496910
Fall 33.24 15.34 398 47960 481412 90098677
Severe acute respiratory syndrome 33.23 15.34 7 48351 35 90580054
Pregnancy 33.15 15.34 90 48268 61957 90518132
Trigeminal neuralgia 33.15 15.34 23 48335 4108 90575981
Invasive breast carcinoma 33.13 15.34 14 48344 925 90579164
Immunodeficiency 33.04 15.34 72 48286 43162 90536927
Rhinorrhoea 33.00 15.34 113 48245 88203 90491886
Platelet count decreased 32.81 15.34 16 48342 136953 90443136
Delirium 32.19 15.34 8 48350 104351 90475738
Stress 32.05 15.34 106 48252 81289 90498800
Vulvovaginal candidiasis 31.97 15.34 22 48336 3878 90576211
Tandem gait test abnormal 31.88 15.34 7 48351 44 90580045
Respiratory tract infection 31.87 15.34 86 48272 58992 90521097
Cardiac failure congestive 31.56 15.34 7 48351 98687 90481402
Nasal herpes 31.44 15.34 13 48345 813 90579276
Paraesthesia ear 31.15 15.34 11 48347 446 90579643
Pruritus 30.90 15.34 432 47926 541093 90038996
Feeling abnormal 30.84 15.34 173 48185 167062 90413027
Grip strength decreased 30.77 15.34 6 48352 92570 90487519
Hypersomnia 30.72 15.34 47 48311 21484 90558605
Sepsis 30.54 15.34 182 48176 179632 90400457
Haemoglobin decreased 30.45 15.34 25 48333 161931 90418158
Bladder disorder 30.43 15.34 33 48325 10739 90569350
CD8 lymphocytes decreased 30.42 15.34 9 48349 205 90579884
Feeling hot 30.19 15.34 101 48257 77907 90502182
Ear discomfort 30.14 15.34 32 48326 10168 90569921
Lymph node pain 30.13 15.34 16 48342 1765 90578324
Paraparesis 29.97 15.34 19 48339 2919 90577170
Memory impairment 29.97 15.34 194 48164 197050 90383039
Hepatitis B virus test positive 29.78 15.34 9 48349 221 90579868
Intervertebral disc protrusion 28.89 15.34 52 48306 27144 90552945
Peripheral venous disease 28.83 15.34 5 48353 83916 90496173
Hypercholesterolaemia 28.76 15.34 9 48349 100883 90479206
Lobular breast carcinoma in situ 28.74 15.34 7 48351 73 90580016
Ophthalmic herpes zoster 28.37 15.34 18 48340 2770 90577319
Encephalitis 27.83 15.34 32 48326 11102 90568987
Tubo-ovarian abscess 27.66 15.34 10 48348 434 90579655
Adverse drug reaction 27.40 15.34 14 48344 116687 90463402
Borrelia infection 27.34 15.34 9 48349 294 90579795
Vision blurred 27.31 15.34 124 48234 110169 90469920
Perinatal stroke 27.20 15.34 5 48353 10 90580079
Lung disorder 27.12 15.34 24 48334 149859 90430230
Osteoarthritis 27.07 15.34 39 48319 195691 90384398
Dehydration 26.64 15.34 39 48319 194408 90385681
Blood cholesterol increased 26.33 15.34 44 48314 207968 90372121
Red blood cell sedimentation rate increased 26.12 15.34 6 48352 82589 90497500
Basal cell carcinoma 25.97 15.34 56 48302 33333 90546756
Temperature intolerance 25.83 15.34 32 48326 11998 90568091
Infrapatellar fat pad inflammation 25.51 15.34 8 48350 223 90579866
Pleural effusion 25.46 15.34 14 48344 111977 90468112
Acquired diaphragmatic eventration 25.44 15.34 10 48348 548 90579541
Muscle spasms 25.42 15.34 225 48133 251658 90328431
Magnetic resonance imaging spinal abnormal 25.41 15.34 8 48350 226 90579863
Cervix carcinoma 25.29 15.34 18 48340 3348 90576741
Dry mouth 25.13 15.34 37 48321 184022 90396067
Breast abscess 25.04 15.34 15 48343 2085 90578004
Hepatitis B 24.73 15.34 20 48338 4499 90575590
Prescribed underdose 24.64 15.34 5 48353 75014 90505075
Cerebral disorder 24.60 15.34 22 48336 5672 90574417
Renal impairment 24.23 15.34 13 48345 105408 90474681
Band sensation 24.07 15.34 12 48346 1161 90578928
Anal incontinence 23.96 15.34 36 48322 16194 90563895
Interchange of vaccine products 23.91 15.34 4 48354 3 90580086
Renal failure 23.67 15.34 21 48337 130986 90449103
Speech disorder 23.23 15.34 65 48293 45520 90534569
Loss of personal independence in daily activities 23.20 15.34 23 48335 136082 90444007
Meningitis enteroviral 22.97 15.34 5 48353 30 90580059
Injection site erythema 22.85 15.34 12 48346 98490 90481599
Myelitis 22.61 15.34 14 48344 2064 90578025
Salpingitis 22.59 15.34 8 48350 327 90579762
Invasive lobular breast carcinoma 22.52 15.34 11 48347 1018 90579071
Vertebral osteophyte 22.46 15.34 9 48349 519 90579570
Bronchitis 22.36 15.34 149 48209 152778 90427311
Meningitis 22.26 15.34 25 48333 8456 90571633
Diplopia 22.15 15.34 48 48310 28666 90551423
Vulvovaginal inflammation 21.85 15.34 11 48347 1087 90579002
Burning sensation 21.82 15.34 79 48279 63373 90516716
Autoimmune disorder 21.60 15.34 7 48351 76737 90503352
Chest discomfort 21.57 15.34 137 48221 138228 90441861
Granuloma annulare 21.46 15.34 10 48348 834 90579255
Colitis microscopic 21.31 15.34 28 48330 11131 90568958
Aortic disorder 21.28 15.34 10 48348 850 90579239
Humoral immune defect 21.21 15.34 8 48350 392 90579697
B-lymphocyte count abnormal 21.06 15.34 6 48352 119 90579970
Vertigo 20.77 15.34 83 48275 69728 90510361
Oropharyngeal discomfort 20.64 15.34 23 48335 7712 90572377
Contusion 20.63 15.34 67 48291 251149 90328940
Arthritis 20.61 15.34 36 48322 167279 90412810
Post-acute COVID-19 syndrome 20.61 15.34 11 48347 1226 90578863
Monoparesis 20.41 15.34 13 48345 2014 90578075
Adjustment disorder with depressed mood 20.35 15.34 3 48355 56750 90523339
Injection site reaction 20.23 15.34 12 48346 92068 90488021
Atrial fibrillation 20.12 15.34 25 48333 133586 90446503
Hyperkalaemia 19.99 15.34 5 48353 64959 90515130
Candida infection 19.81 15.34 51 48307 34006 90546083
Occipital neuralgia 19.77 15.34 9 48349 711 90579378
Interleukin level increased 19.75 15.34 9 48349 713 90579376
Kidney infection 19.62 15.34 43 48315 25873 90554216
Intercepted product storage error 19.61 15.34 8 48350 483 90579606
Retention cyst 19.61 15.34 3 48355 0 90580089
Unevaluable event 19.44 15.34 3 48355 54845 90525244
Cardio-respiratory arrest 19.16 15.34 5 48353 63135 90516954
Thyroid cancer 19.07 15.34 20 48338 6264 90573825
Abdominal pain upper 19.06 15.34 102 48256 332572 90247517
Pyoderma gangrenosum 18.79 15.34 17 48341 4447 90575642
Bladder dysfunction 18.74 15.34 10 48348 1114 90578975
Herpes simplex 18.60 15.34 25 48333 10156 90569933
Lipoedema 18.57 15.34 7 48351 342 90579747
Atypical pneumonia 18.54 15.34 18 48340 5146 90574943
Cellulitis 18.52 15.34 97 48261 91240 90488849
Night sweats 18.45 15.34 25 48333 128741 90451348
Uvulitis 18.38 15.34 4 48354 24 90580065
Depressed level of consciousness 18.21 15.34 8 48350 72776 90507313
Coma 18.14 15.34 8 48350 72624 90507465
Secondary progressive multiple sclerosis 18.11 15.34 11 48347 1568 90578521
Electrocardiogram QT prolonged 18.07 15.34 8 48350 72448 90507641
Terminal insomnia 18.01 15.34 10 48348 1205 90578884
Selective IgA immunodeficiency 17.97 15.34 4 48354 27 90580062
White matter lesion 17.84 15.34 13 48345 2508 90577581
Lower respiratory tract infection 17.83 15.34 71 48287 250588 90329501
Paranasal sinus mucosal hypertrophy 17.60 15.34 4 48354 30 90580059
Blepharospasm 17.59 15.34 4 48354 55441 90524648
Progressive multiple sclerosis 17.42 15.34 10 48348 1284 90578805
Neuropathy peripheral 17.30 15.34 29 48329 136941 90443148
Hepatitis B surface antibody positive 17.28 15.34 6 48352 231 90579858
Herpes simplex encephalitis 17.27 15.34 7 48351 416 90579673
Hot flush 17.12 15.34 70 48288 59418 90520671
Abdominal distension 17.11 15.34 27 48331 130574 90449515
Meningitis staphylococcal 17.06 15.34 5 48353 110 90579979
Blood immunoglobulin A decreased 17.03 15.34 11 48347 1745 90578344
Dysmetria 16.94 15.34 8 48350 687 90579402
Ligament sprain 16.91 15.34 29 48329 14570 90565519
Pulmonary oedema 16.88 15.34 6 48352 62074 90518015
Ill-defined disorder 16.83 15.34 47 48311 184844 90395245
Varicella zoster virus infection 16.79 15.34 15 48343 3862 90576227
Impatience 16.77 15.34 7 48351 448 90579641
Restless legs syndrome 16.69 15.34 37 48321 22433 90557656
Norovirus infection 16.54 15.34 11 48347 1833 90578256
Mood disorder due to a general medical condition 16.50 15.34 5 48353 124 90579965
Disturbance in attention 16.49 15.34 59 48299 47050 90533039
Gastric infection 16.45 15.34 15 48343 3965 90576124
Depression 16.38 15.34 238 48120 300363 90279726
Suicide attempt 16.32 15.34 10 48348 75389 90504700
Herpes pharyngitis 16.32 15.34 3 48355 6 90580083
Sedation 16.27 15.34 3 48355 48168 90531921
Varicella 16.12 15.34 12 48346 2390 90577699
Progressive relapsing multiple sclerosis 16.07 15.34 4 48354 46 90580043
Uterine infection 16.04 15.34 7 48351 500 90579589
Cardiac failure 15.95 15.34 21 48337 109475 90470614
Muscle twitching 15.93 15.34 38 48320 24164 90555925
Weight decreased 15.92 15.34 128 48230 379782 90200307
Heart rate increased 15.90 15.34 109 48249 112793 90467296
Tooth fracture 15.89 15.34 26 48332 12574 90567515
Muscle discomfort 15.88 15.34 6 48352 295 90579794
Immunoglobulins abnormal 15.69 15.34 5 48353 147 90579942
Rhabdomyolysis 15.67 15.34 4 48354 51252 90528837
Electric shock sensation 15.64 15.34 10 48348 1560 90578529
Lyme disease 15.57 15.34 15 48343 4247 90575842
Nail disorder 15.57 15.34 6 48352 59061 90521028
Vulvovaginal mycotic infection 15.54 15.34 18 48340 6296 90573793
Hyperglycaemia 15.54 15.34 4 48354 50966 90529123
Atonic urinary bladder 15.50 15.34 5 48353 153 90579936
Hypoglycaemia 15.49 15.34 9 48349 69839 90510250
Ear infection 15.48 15.34 76 48282 69699 90510390
Sleep disorder 15.44 15.34 54 48304 197976 90382113
Breast cyst 15.40 15.34 11 48347 2056 90578033
Infection 15.35 15.34 275 48083 361819 90218270

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
COVID-19 2904.64 18.93 1212 14823 114736 42490564
Multiple sclerosis relapse 603.77 18.93 220 15815 14044 42591256
Multiple sclerosis 557.08 18.93 177 15858 7421 42597879
Urinary tract infection 460.07 18.93 344 15691 98940 42506360
JC polyomavirus test positive 320.40 18.93 75 15960 956 42604344
SARS-CoV-2 test positive 236.71 18.93 96 15939 8164 42597136
Infusion related reaction 225.40 18.93 185 15850 60621 42544679
COVID-19 pneumonia 211.54 18.93 120 15915 21493 42583807
Herpes zoster 182.35 18.93 136 15899 38741 42566559
Throat irritation 177.00 18.93 90 15945 12946 42592354
Influenza 147.07 18.93 147 15888 62028 42543272
Muscular weakness 122.70 18.93 154 15881 83344 42521956
Gait disturbance 119.65 18.93 165 15870 97835 42507465
B-lymphocyte count decreased 115.04 18.93 32 16003 837 42604463
Nasopharyngitis 109.45 18.93 146 15889 83850 42521450
Lymphopenia 100.06 18.93 75 15960 21488 42583812
Magnetic resonance imaging abnormal 92.83 18.93 32 16003 1726 42603574
Blood immunoglobulin M decreased 92.62 18.93 27 16008 839 42604461
Urosepsis 87.50 18.93 60 15975 14960 42590340
Demyelination 87.48 18.93 37 15998 3492 42601808
Acute kidney injury 86.04 18.93 17 16018 367320 42237980
Coronavirus infection 85.64 18.93 41 15994 5173 42600127
Muscle spasticity 80.82 18.93 43 15992 6779 42598521
Balance disorder 79.87 18.93 94 15941 47551 42557749
No adverse event 79.11 18.93 85 15950 38936 42566364
SARS-CoV-2 antibody test negative 77.27 18.93 14 16021 41 42605259
Ear pruritus 74.52 18.93 22 16013 715 42604585
Blood immunoglobulin G decreased 73.57 18.93 29 16006 2285 42603015
Toxicity to various agents 70.14 18.93 4 16031 229132 42376168
Hypoaesthesia 69.27 18.93 108 15927 71355 42533945
Drug interaction 65.37 18.93 11 16024 266988 42338312
Fatigue 60.14 18.93 322 15713 435319 42169981
Anaemia 59.53 18.93 16 16019 280262 42325038
Oral herpes 58.33 18.93 36 15999 7508 42597792
Mobility decreased 58.07 18.93 69 15966 35237 42570063
Infection 56.54 18.93 128 15907 111940 42493360
Hypogammaglobulinaemia 54.35 18.93 41 15994 11850 42593450
Diarrhoea 52.29 18.93 58 15977 460791 42144509
Memory impairment 50.18 18.93 77 15958 50145 42555155
Product use in unapproved indication 48.83 18.93 6 16029 184450 42420850
Expanded disability status scale score increased 47.87 18.93 14 16021 440 42604860
Pruritus 47.10 18.93 167 15868 188604 42416696
Cystitis 44.09 18.93 36 15999 11662 42593638
Urinary incontinence 41.79 18.93 46 15989 21622 42583678
Fall 40.50 18.93 185 15850 234335 42370965
B-lymphocyte count increased 39.98 18.93 8 16027 45 42605255
Hemiparesis 39.03 18.93 40 15995 17336 42587964
Breast cancer 38.62 18.93 11 16024 314 42604986
Peroneal nerve palsy 38.47 18.93 21 16014 3481 42601819
Neurogenic bladder 37.81 18.93 18 16017 2242 42603058
Decreased appetite 37.40 18.93 13 16022 193124 42412176
Congenital megacolon 37.21 18.93 8 16027 67 42605233
Relapsing multiple sclerosis 37.16 18.93 6 16029 6 42605294
Magnetic resonance imaging spinal abnormal 36.95 18.93 9 16026 137 42605163
Thrombocytopenia 36.52 18.93 13 16022 190266 42415034
Sensory disturbance 36.11 18.93 26 16009 6997 42598303
Selective IgG subclass deficiency 35.82 18.93 6 16029 9 42605291
Pneumonia 35.78 18.93 276 15759 421873 42183427
Optic neuritis 35.19 18.93 21 16014 4121 42601179
Respiratory syncytial virus bronchitis 34.38 18.93 8 16027 99 42605201
Pancytopenia 33.27 18.93 3 16032 117740 42487560
Paraparesis 33.14 18.93 16 16019 2055 42603245
Circulatory failure neonatal 33.00 18.93 6 16029 18 42605282
Cellulitis 32.88 18.93 72 15963 61513 42543787
Antibody test negative 32.76 18.93 6 16029 19 42605281
Progressive multiple sclerosis 31.83 18.93 9 16026 250 42605050
Haemoglobin decreased 31.20 18.93 6 16029 132465 42472835
Product dose omission issue 30.56 18.93 10 16025 154355 42450945
Asthenia 30.42 18.93 195 15840 280598 42324702
Immunoglobulins decreased 29.71 18.93 12 16023 1007 42604293
Condition aggravated 29.28 18.93 33 16002 260721 42344579
Influenza like illness 29.27 18.93 47 15988 31793 42573507
Urticaria 29.23 18.93 77 15958 73959 42531341
Disability 28.32 18.93 21 16014 5912 42599388
Renal impairment 28.16 18.93 4 16031 110224 42495076
Hypotension 27.43 18.93 34 16001 257597 42347703
Overdose 26.47 18.93 4 16031 105260 42500040
Platelet count decreased 25.68 18.93 10 16025 138571 42466729
Lymphocyte count decreased 25.49 18.93 41 15994 27768 42577532
Oedema peripheral 24.92 18.93 10 16025 136066 42469234
Gastrointestinal haemorrhage 23.93 18.93 4 16031 97722 42507578
Sensory loss 23.84 18.93 18 16017 5206 42600094
Foetal exposure during pregnancy 23.77 18.93 54 15981 47257 42558043
Visual impairment 23.68 18.93 51 15984 43062 42562238
Upper respiratory tract infection 23.29 18.93 50 15985 42123 42563177
Muscle spasms 23.03 18.93 78 15957 85966 42519334
Rectal polyp 22.76 18.93 9 16026 715 42604585
Burning sensation 22.08 18.93 33 16002 20980 42584320
Paraesthesia 21.82 18.93 69 15966 73390 42531910
Poor feeding infant 21.44 18.93 9 16026 833 42604467
Drug ineffective 21.06 18.93 145 15890 630052 41975248
Dehydration 20.66 18.93 14 16021 141753 42463547
Hyperkalaemia 20.36 18.93 3 16032 80455 42524845
Herpes simplex encephalitis 20.31 18.93 7 16028 377 42604923
Migraine 20.00 18.93 35 16000 25379 42579921
Cardiac failure congestive 19.89 18.93 4 16031 85598 42519702
Renal failure 19.89 18.93 15 16020 143711 42461589
Otitis media 19.77 18.93 14 16021 3669 42601631
Neuralgia 19.77 18.93 35 16000 25612 42579688
Bladder disorder 19.72 18.93 14 16021 3685 42601615
Progressive multifocal leukoencephalopathy 19.71 18.93 23 16012 11513 42593787
Completed suicide 19.52 18.93 6 16029 96459 42508841
Vaccination failure 19.49 18.93 10 16025 1462 42603838
Myeloid maturation arrest 19.36 18.93 4 16031 27 42605273

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
COVID-19 7094.53 16.01 2987 46244 242073 110297995
Multiple sclerosis relapse 976.51 16.01 467 48764 49773 110490295
Multiple sclerosis 960.48 16.01 379 48852 25319 110514749
Urinary tract infection 929.64 16.01 920 48311 325362 110214706
Throat irritation 859.63 16.01 437 48794 53115 110486953
Infusion related reaction 731.73 16.01 873 48358 380289 110159779
Maternal exposure before pregnancy 575.30 16.01 187 49044 7078 110532990
SARS-CoV-2 test positive 547.12 16.01 225 49006 16710 110523358
JC polyomavirus test positive 493.47 16.01 129 49102 2218 110537850
COVID-19 pneumonia 487.34 16.01 265 48966 36878 110503190
Herpes zoster 472.37 16.01 389 48842 107990 110432078
Coronavirus infection 392.62 16.01 151 49080 9394 110530674
B-lymphocyte count decreased 356.39 16.01 97 49134 1958 110538110
Oral herpes 330.92 16.01 204 49027 35876 110504192
Influenza 317.96 16.01 384 48847 168717 110371351
Breast cancer 251.15 16.01 176 49055 38366 110501702
Nasopharyngitis 240.28 16.01 537 48694 393824 110146244
Gait disturbance 235.06 16.01 434 48797 277774 110262294
Ear pruritus 229.49 16.01 95 49136 7165 110532903
Fatigue 206.79 16.01 1075 48156 1214883 109325185
Lymphopenia 204.33 16.01 158 49073 40012 110500056
SARS-CoV-2 antibody test negative 203.04 16.01 45 49186 365 110539703
Muscle spasticity 201.99 16.01 150 49081 35765 110504303
Oropharyngeal pain 185.34 16.01 263 48968 135013 110405055
Toxicity to various agents 180.07 16.01 8 49223 480547 110059521
Blood immunoglobulin M decreased 171.61 16.01 55 49176 1986 110538082
Acute kidney injury 159.46 16.01 43 49188 635387 109904681
Cystitis noninfective 143.24 16.01 46 49185 1672 110538396
Optic neuritis 141.89 16.01 78 49153 11069 110528999
Muscular weakness 140.72 16.01 329 48902 248139 110291929
Magnetic resonance imaging abnormal 136.22 16.01 55 49176 3890 110536178
Condition aggravated 133.68 16.01 81 49150 734755 109805313
Balance disorder 132.93 16.01 208 49023 116352 110423716
Blood immunoglobulin G decreased 125.89 16.01 57 49174 5343 110534725
Product use in unapproved indication 124.69 16.01 24 49207 447353 110092715
Drug ineffective 119.22 16.01 319 48912 1520221 109019847
Hypoaesthesia 116.91 16.01 356 48875 313867 110226201
Urinary incontinence 114.27 16.01 124 49107 48463 110491605
Product use issue 108.11 16.01 8 49223 311687 110228381
Throat tightness 105.31 16.01 100 49131 33389 110506679
Joint swelling 103.66 16.01 34 49197 442811 110097257
Sensory disturbance 102.95 16.01 75 49156 17354 110522714
Cystitis 100.30 16.01 135 49096 65901 110474167
Rheumatoid arthritis 100.27 16.01 9 49222 299604 110240464
Abortion spontaneous 99.58 16.01 98 49133 34184 110505884
Herpes virus infection 97.87 16.01 56 49175 8582 110531486
Relapsing multiple sclerosis 97.32 16.01 22 49209 197 110539871
Anaemia 95.69 16.01 63 49168 547023 109993045
Drug interaction 93.88 16.01 53 49178 500130 110039938
Hypogammaglobulinaemia 93.53 16.01 75 49156 20001 110520067
Genital herpes 93.10 16.01 37 49194 2510 110537558
Systemic lupus erythematosus 92.74 16.01 5 49226 254333 110285735
Peroneal nerve palsy 89.22 16.01 50 49181 7364 110532704
Urosepsis 87.81 16.01 87 49144 30588 110509480
Product dose omission issue 86.02 16.01 19 49212 321763 110218305
Invasive ductal breast carcinoma 85.95 16.01 47 49184 6599 110533469
Demyelination 85.62 16.01 53 49178 9376 110530692
Glossodynia 85.44 16.01 3 49228 222001 110318067
Thrombocytopenia 84.82 16.01 25 49206 348860 110191208
Completed suicide 84.67 16.01 6 49225 242375 110297693
Diarrhoea 83.21 16.01 247 48984 1139258 109400810
Agranulocytosis 81.47 16.01 118 49113 61642 110478426
Pancytopenia 80.08 16.01 3 49228 209610 110330458
Influenza like illness 79.67 16.01 142 49089 88270 110451798
Headache 79.20 16.01 666 48565 881711 109658357
Drug intolerance 76.37 16.01 43 49188 406469 110133599
Lymphocyte count decreased 74.97 16.01 109 49122 57134 110482934
Hepatic enzyme increased 74.42 16.01 25 49206 320867 110219201
Treatment failure 72.83 16.01 17 49214 277217 110262851
Selective IgG subclass deficiency 72.41 16.01 13 49218 28 110540040
Therapeutic product effect incomplete 71.54 16.01 8 49223 223797 110316271
Neuralgia 70.42 16.01 97 49134 48381 110491687
Illness 70.25 16.01 129 49102 82042 110458026
Expanded disability status scale score increased 70.11 16.01 23 49208 895 110539173
General physical health deterioration 69.04 16.01 53 49178 425242 110114826
Human papilloma virus test positive 68.86 16.01 21 49210 642 110539426
Cough 68.31 16.01 394 48837 461247 110078821
Asthenia 67.11 16.01 530 48701 688469 109851599
Upper respiratory tract infection 66.87 16.01 167 49064 131161 110408907
Psoriatic arthropathy 65.57 16.01 6 49225 196755 110343313
Immunoglobulins decreased 64.54 16.01 28 49203 2371 110537697
Oedema peripheral 64.30 16.01 33 49198 328627 110211441
Arthropathy 63.93 16.01 24 49207 287498 110252570
Abdominal pain 63.63 16.01 81 49150 512908 110027160
No adverse event 63.22 16.01 116 49115 73723 110466345
Neurogenic bladder 63.16 16.01 35 49196 5044 110535024
Vitamin D deficiency 61.39 16.01 57 49174 18495 110521573
Vaginal infection 61.16 16.01 38 49193 6766 110533302
Memory impairment 60.39 16.01 209 49022 196735 110343333
Decreased appetite 60.20 16.01 74 49157 475772 110064296
Malignant melanoma 60.00 16.01 54 49177 16837 110523231
Helicobacter infection 59.41 16.01 6 49225 181871 110358197
Fall 59.16 16.01 465 48766 603017 109937051
Exposure during pregnancy 58.88 16.01 4 49227 167420 110372648
Overdose 56.35 16.01 17 49214 233777 110306291
Paraesthesia 55.46 16.01 257 48974 276264 110263804
Papilloma viral infection 54.42 16.01 24 49207 2114 110537954
Ataxia 54.25 16.01 67 49164 30041 110510027
Pneumonia 53.65 16.01 611 48620 876103 109663965
Paraparesis 52.80 16.01 30 49201 4536 110535532
Immunisation reaction 52.77 16.01 18 49213 791 110539277
Pericarditis 52.69 16.01 16 49215 219098 110320970
Gastrointestinal haemorrhage 52.68 16.01 6 49225 165512 110374556
Trigeminal neuralgia 51.42 16.01 29 49202 4323 110535745
Pruritus 50.47 16.01 436 48795 581124 109958944
Haemoglobin decreased 50.11 16.01 24 49207 248703 110291365
Abdominal discomfort 50.06 16.01 61 49170 393797 110146271
Organising pneumonia 49.54 16.01 45 49186 14198 110525870
Blood creatinine increased 48.45 16.01 11 49220 182878 110357190
Platelet count decreased 48.34 16.01 21 49210 230422 110309646
Hemiparesis 48.15 16.01 77 49154 43826 110496242
Limb discomfort 48.07 16.01 74 49157 40780 110499288
Fibromyalgia 47.92 16.01 9 49222 170900 110369168
Oedema 47.56 16.01 17 49214 209959 110330109
Micturition urgency 46.63 16.01 50 49181 19270 110520798
Swelling 46.07 16.01 53 49178 350988 110189080
Hyponatraemia 45.40 16.01 20 49211 217633 110322435
Immunosuppression 44.70 16.01 47 49184 17712 110522356
Hypokalaemia 44.45 16.01 13 49218 182435 110357633
Injury 44.36 16.01 12 49219 177253 110362815
Vomiting 44.22 16.01 232 48999 910443 109629625
Rhinorrhoea 43.55 16.01 122 49109 102544 110437524
Bacterial vaginosis 43.14 16.01 18 49213 1384 110538684
Renal impairment 43.12 16.01 15 49216 188430 110351638
Progressive multifocal leukoencephalopathy 42.51 16.01 54 49177 24902 110515166
Wheezing 42.43 16.01 31 49200 255199 110284869
Cardiac failure congestive 42.23 16.01 8 49223 150992 110389076
Liver injury 42.00 16.01 8 49223 150405 110389663
Oral pruritus 41.61 16.01 23 49208 3297 110536771
Clumsiness 41.47 16.01 24 49207 3756 110536312
Wound 40.92 16.01 27 49204 234410 110305658
West Nile viral infection 40.72 16.01 17 49214 1309 110538759
Central nervous system lesion 40.65 16.01 42 49189 15511 110524557
Hyperkalaemia 40.62 16.01 6 49225 135790 110404278
Muscle spasms 40.16 16.01 236 48995 277921 110262147
Flushing 40.12 16.01 120 49111 104616 110435452
Feeling abnormal 40.00 16.01 173 49058 180538 110359530
Injection site pain 39.29 16.01 15 49216 177907 110362161
Bronchitis 39.20 16.01 156 49075 156876 110383192
Folliculitis 38.95 16.01 13 49218 167640 110372428
Gastrointestinal infection 38.75 16.01 39 49192 13966 110526102
Stomatitis 38.58 16.01 38 49193 270204 110269864
B-lymphocyte abnormalities 38.52 16.01 10 49221 167 110539901
Ophthalmic herpes zoster 38.43 16.01 22 49209 3373 110536695
Immunodeficiency 38.39 16.01 65 49166 38773 110501295
Impaired healing 38.08 16.01 20 49211 196697 110343371
Magnetic resonance imaging head abnormal 37.61 16.01 22 49209 3513 110536555
Blister 37.29 16.01 28 49203 227348 110312720
T-lymphocyte count decreased 37.24 16.01 13 49218 613 110539455
Liver disorder 36.79 16.01 9 49222 142234 110397834
Pyelonephritis 35.88 16.01 50 49181 25200 110514868
Hypotension 35.64 16.01 117 49114 523732 110016336
Decreased vibratory sense 35.46 16.01 13 49218 707 110539361
T-lymphocyte count increased 35.33 16.01 10 49221 234 110539834
Suspected COVID-19 35.22 16.01 21 49210 3472 110536596
Burning sensation 35.20 16.01 88 49143 69124 110470944
Rhabdomyolysis 34.48 16.01 6 49225 120395 110419673
Magnetic resonance imaging spinal abnormal 34.41 16.01 10 49221 258 110539810
Cervical dysplasia 34.39 16.01 19 49212 2721 110537347
Irritable bowel syndrome 34.38 16.01 15 49216 164200 110375868
Pulmonary fibrosis 34.29 16.01 3 49228 102039 110438029
Progressive multiple sclerosis 34.14 16.01 15 49216 1309 110538759
Bursitis 34.04 16.01 8 49223 129910 110410158
Intervertebral disc protrusion 33.75 16.01 51 49180 27647 110512421
Hospitalisation 33.19 16.01 11 49220 142482 110397586
Meningitis 33.14 16.01 33 49198 11669 110528399
Borrelia infection 32.88 16.01 10 49221 303 110539765
Dehydration 32.72 16.01 46 49185 279465 110260603
Cardio-respiratory arrest 32.68 16.01 6 49225 115830 110424238
Bladder disorder 32.64 16.01 32 49199 11105 110528963
Hypoxia 31.97 16.01 9 49222 129506 110410562
Therapeutic product effect decreased 31.92 16.01 37 49194 244279 110295789
Lymph node pain 31.87 16.01 16 49215 1886 110538182
Colitis 31.70 16.01 109 49122 102214 110437854
Pleural effusion 31.64 16.01 20 49211 177689 110362379
Lobular breast carcinoma in situ 31.45 16.01 7 49224 58 110540010
Inflammation 31.43 16.01 24 49207 193214 110346854
Paraesthesia ear 31.40 16.01 11 49220 524 110539544
Renal failure 31.04 16.01 33 49198 226541 110313527
Confusional state 30.97 16.01 106 49125 468574 110071494
Encephalitis 30.89 16.01 40 49191 18799 110521269
Feeling hot 30.84 16.01 100 49131 91006 110449062
Musculoskeletal pain 30.71 16.01 22 49209 183001 110357067
Invasive breast carcinoma 30.64 16.01 12 49219 783 110539285
Breast abscess 30.22 16.01 15 49216 1726 110538342
Herpes simplex encephalitis 29.93 16.01 12 49219 833 110539235
Anogenital warts 29.72 16.01 13 49218 1123 110538945
Depression 29.64 16.01 242 48989 317093 110222975
Hypersomnia 29.12 16.01 48 49183 28013 110512055
Neuroborreliosis 28.78 16.01 8 49223 175 110539893
Secondary progressive multiple sclerosis 28.67 16.01 14 49217 1555 110538513
Lip dry 28.63 16.01 5 49226 100078 110439990
Temperature intolerance 28.34 16.01 33 49198 13917 110526151
Meningitis enteroviral 28.31 16.01 7 49224 95 110539973
Muscle twitching 28.14 16.01 49 49182 29886 110510182
Humoral immune defect 27.74 16.01 11 49220 742 110539326
Heart rate increased 27.57 16.01 132 49099 143702 110396366
Oxygen saturation decreased 27.50 16.01 18 49213 156964 110383104
Vision blurred 27.39 16.01 122 49109 128900 110411168
Joint range of motion decreased 27.35 16.01 10 49221 121822 110418246
Salpingitis 27.14 16.01 8 49223 217 110539851
CD4 lymphocytes increased 27.03 16.01 9 49222 367 110539701
Hypoglycaemia 26.97 16.01 9 49222 116095 110423973
Infrapatellar fat pad inflammation 26.94 16.01 8 49223 223 110539845
Hepatic function abnormal 26.58 16.01 4 49227 89291 110450777
Stress 26.56 16.01 105 49126 105243 110434825
Pharyngeal disorder 26.30 16.01 16 49215 2743 110537325
Severe acute respiratory syndrome 26.28 16.01 8 49223 243 110539825
Visual impairment 26.23 16.01 124 49107 134304 110405764
Tubo-ovarian abscess 26.18 16.01 9 49222 405 110539663
Bladder dysfunction 26.17 16.01 13 49218 1499 110538569
Electrocardiogram QT prolonged 26.10 16.01 8 49223 108952 110431116
Cardiac failure 26.07 16.01 27 49204 187599 110352469
Coma 25.91 16.01 10 49221 117859 110422209
Multiple organ dysfunction syndrome 25.76 16.01 18 49213 151692 110388376
Atrial fibrillation 25.69 16.01 39 49192 229603 110310465
B-lymphocyte count increased 25.68 16.01 7 49224 142 110539926
Post-acute COVID-19 syndrome 25.66 16.01 13 49218 1562 110538506
Depressed level of consciousness 25.57 16.01 9 49222 112269 110427799
Pharyngeal swelling 25.34 16.01 29 49202 12003 110528065
Loss of personal independence in daily activities 25.21 16.01 18 49213 150002 110390066
Death 25.16 16.01 195 49036 698674 109841394
Cervix carcinoma 25.13 16.01 15 49216 2486 110537582
Occipital neuralgia 24.94 16.01 10 49221 694 110539374
Nausea 24.85 16.01 394 48837 1235296 109304772
Therapeutic response shortened 24.72 16.01 46 49185 29537 110510531
Peripheral swelling 24.30 16.01 95 49136 403939 110136129
Sensory loss 24.03 16.01 38 49193 21419 110518649
Acquired diaphragmatic eventration 23.93 16.01 10 49221 772 110539296
Lung disorder 23.80 16.01 27 49204 180020 110360048
Ascites 23.75 16.01 6 49225 92802 110447266
Vulvovaginal candidiasis 23.75 16.01 16 49215 3269 110536799
Migraine 23.71 16.01 144 49087 171508 110368560
Initial insomnia 23.52 16.01 26 49205 10363 110529705
Cognitive disorder 23.51 16.01 89 49142 87422 110452646
Ear discomfort 23.50 16.01 27 49204 11222 110528846
Anal incontinence 23.37 16.01 38 49193 21926 110518142
Granuloma annulare 23.07 16.01 10 49221 845 110539223
Delirium 22.95 16.01 16 49215 135009 110405059
Respiratory tract infection 22.80 16.01 77 49154 71540 110468528
Vaccination failure 22.53 16.01 14 49217 2492 110537576
Dry throat 22.45 16.01 24 49207 9214 110530854
Basal cell carcinoma 22.43 16.01 57 49174 45213 110494855
Peripheral venous disease 22.39 16.01 5 49226 84112 110455956
Treatment noncompliance 22.36 16.01 3 49228 72987 110467081
Disease progression 22.30 16.01 47 49184 243987 110296081
Fungal infection 22.15 16.01 61 49170 50745 110489323
Speech disorder 22.13 16.01 69 49162 61500 110478568
Lipoedema 22.13 16.01 7 49224 242 110539826
Tremor 22.09 16.01 160 49071 202072 110337996
Infection susceptibility increased 21.70 16.01 17 49214 4381 110535687
Cellulitis 21.57 16.01 112 49119 125904 110414164
Band sensation 20.85 16.01 10 49221 1068 110539000
Drug hypersensitivity 20.70 16.01 118 49113 453972 110086096
Intraductal proliferative breast lesion 20.64 16.01 14 49217 2891 110537177
CD8 lymphocytes decreased 20.56 16.01 7 49224 306 110539762
Aortic disorder 20.47 16.01 10 49221 1112 110538956
Therapy non-responder 20.35 16.01 24 49207 157283 110382785
Meniscus injury 20.29 16.01 21 49210 7772 110532296
Hepatic cirrhosis 20.19 16.01 3 49228 67623 110472445
Red blood cell sedimentation rate increased 20.16 16.01 5 49226 78297 110461771
Erysipelas 20.12 16.01 27 49204 13131 110526937
Invasive lobular breast carcinoma 20.06 16.01 9 49222 825 110539243
Vertebral osteophyte 20.04 16.01 8 49223 549 110539519
Adverse drug reaction 20.03 16.01 11 49220 105548 110434520
Diplopia 19.98 16.01 52 49179 41842 110498226
Medication error 19.97 16.01 11 49220 105355 110434713
Selective IgA immunodeficiency 19.39 16.01 4 49227 22 110540046
Monoparesis 19.09 16.01 16 49215 4537 110535531
Discomfort 19.07 16.01 42 49189 214665 110325403
Neoplasm progression 18.98 16.01 3 49228 64592 110475476
Type 2 diabetes mellitus 18.96 16.01 31 49200 177201 110362867
Hypertonic bladder 18.93 16.01 17 49214 5285 110534783
White matter lesion 18.92 16.01 13 49218 2741 110537327
Cerebral disorder 18.87 16.01 19 49212 6807 110533261
Injection site reaction 18.86 16.01 8 49223 89062 110451006
Varicella virus test positive 18.85 16.01 7 49224 395 110539673
Blood immunoglobulin A decreased 18.81 16.01 12 49219 2236 110537832
Infection 18.81 16.01 245 48986 361955 110178113
Hot flush 18.44 16.01 68 49163 65968 110474100
Fine motor skill dysfunction 18.33 16.01 18 49213 6256 110533812
Blood pressure systolic increased 18.31 16.01 7 49224 82984 110457084
Meningitis viral 18.10 16.01 12 49219 2387 110537681
Herpes pharyngitis 18.07 16.01 3 49228 3 110540065
Eye infection 18.07 16.01 27 49204 14491 110525577
Hypercholesterolaemia 17.93 16.01 9 49222 90828 110449240
Terminal insomnia 17.87 16.01 11 49220 1927 110538141
Lyme disease 17.75 16.01 15 49216 4301 110535767
Neuropathy peripheral 17.69 16.01 33 49198 179244 110360824
Sepsis 17.66 16.01 223 49008 327123 110212945
Menstruation irregular 17.63 16.01 17 49214 5780 110534288
Hyperpathia 17.61 16.01 3 49228 4 110540064
Skin infection 17.57 16.01 34 49197 22475 110517593
Pulpitis dental 17.43 16.01 10 49221 1539 110538529
Babesiosis 17.43 16.01 7 49224 488 110539580
Encephalitis enteroviral 17.41 16.01 6 49225 272 110539796
Ligament sprain 17.37 16.01 28 49203 16040 110524028
Autoimmune disorder 17.21 16.01 4 49227 65479 110474589
Mood disorder due to a general medical condition 17.17 16.01 5 49226 130 110539938
Cytokine release syndrome 17.14 16.01 5 49226 70301 110469767
Myelitis 17.12 16.01 13 49218 3200 110536868
Insomnia 17.12 16.01 240 48991 360350 110179718
Vitamin D decreased 17.07 16.01 24 49207 12191 110527877
Uvulitis 17.03 16.01 4 49227 43 110540025
Ear infection 17.02 16.01 64 49167 62668 110477400
Mycobacterium tuberculosis complex test positive 16.86 16.01 13 49218 3275 110536793
Unevaluable event 16.85 16.01 3 49228 59224 110480844
Cholestasis 16.84 16.01 4 49227 64514 110475554
Back pain 16.84 16.01 245 48986 370751 110169317
Rash maculo-papular 16.81 16.01 6 49225 74216 110465852
Atypical pneumonia 16.65 16.01 19 49212 7843 110532225
Thyroid cancer 16.64 16.01 17 49214 6197 110533871
Disturbance in attention 16.61 16.01 63 49168 61932 110478136
Abdominal distension 16.61 16.01 33 49198 175070 110364998
Restless legs syndrome 16.60 16.01 35 49196 24591 110515477
Tongue pruritus 16.54 16.01 8 49223 870 110539198
Gastrointestinal disorder 16.45 16.01 54 49177 241898 110298170
Drug ineffective for unapproved indication 16.43 16.01 13 49218 102825 110437243
Sensation of foreign body 16.42 16.01 19 49212 7956 110532112
Hormone receptor positive breast cancer 16.39 16.01 7 49224 570 110539498

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AG08 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
FDA CS M0001357 Antibodies, Monoclonal
FDA CS M0556300 Antibodies, Monoclonal, Humanized
FDA MoA N0000175078 CD20-directed Antibody Interactions
MeSH PA D007155 Immunologic Factors
FDA EPC N0000175657 CD20-directed Cytolytic Antibody
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug

Related Drugs by ATC class:

L04AG Monoclonal antibodies 14 drugs
alemtuzumabanifrolumabaxatilimab-csfrbelimumabefalizumabemapalumabinebilizumabmuromonab-CD3natalizumabofatumumabsibeprenlimab-szsiteprotumumab show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Primary progressive multiple sclerosis indication 428700003 DOID:0050784




🐶 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
B-lymphocyte antigen CD20 Surface antigen ANTIBODY BINDING Kd 9.08 IUPHAR DRUG LABEL

External reference:

IDSource
A10SJL62JY UNII
4036552 VANDF
C1882138 UMLSCUI
CHEBI:753057 CHEBI
CHEMBL2108041 ChEMBL_ID
DB11988 DRUGBANK_ID
D05218 KEGG_DRUG
8636 INN_ID
C533411 MESH_SUPPLEMENTAL_RECORD_UI
7580 IUPHAR_LIGAND_ID
733464008 SNOMEDCT_US
763559000 SNOMEDCT_US
254931 MMSL
32532 MMSL
d08538 MMSL
017151 NDDF
1876366 RXNORM

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
OCREVUS HUMAN PRESCRIPTION DRUG LABEL 1 50242-150 INJECTION 300 mg INTRAVENOUS BLA 30 sections
Ocrevus Zunovo HUMAN PRESCRIPTION DRUG LABEL 2 50242-554 INJECTION, SOLUTION 920 mg SUBCUTANEOUS BLA 31 sections