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

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 5639.69 16.26 2165 32873 110938 63343046
Multiple sclerosis relapse 875.08 16.26 459 34579 48019 63405965
Throat irritation 779.28 16.26 391 34647 37256 63416728
Urinary tract infection 623.35 16.26 747 34291 263937 63190047
Infusion related reaction 542.11 16.26 671 34367 244850 63209134
Multiple sclerosis 509.56 16.26 255 34783 24117 63429867
SARS-CoV-2 test positive 468.93 16.26 174 34864 7882 63446102
Herpes zoster 431.48 16.26 360 34678 82102 63371882
COVID-19 pneumonia 348.92 16.26 166 34872 14043 63439941
Oral herpes 320.31 16.26 192 34846 25882 63428102
JC polyomavirus test positive 307.64 16.26 84 34954 1369 63452615
B-lymphocyte count decreased 263.39 16.26 70 34968 1024 63452960
Coronavirus infection 254.80 16.26 94 34944 4184 63449800
Ear pruritus 217.42 16.26 82 34956 3883 63450101
Maternal exposure before pregnancy 202.58 16.26 94 34944 7509 63446475
Breast cancer 198.22 16.26 184 34854 48199 63405785
No adverse event 192.31 16.26 169 34869 41236 63412748
Influenza 180.35 16.26 259 34779 108463 63345521
SARS-CoV-2 antibody test negative 162.87 16.26 34 35004 155 63453829
Muscle spasticity 159.08 16.26 116 34922 21678 63432306
Nasopharyngitis 146.81 16.26 387 34651 253870 63200114
Gait disturbance 129.08 16.26 301 34737 182877 63271107
Drug ineffective 128.75 16.26 239 34799 1044526 62409458
Herpes virus infection 127.53 16.26 62 34976 5494 63448490
Rheumatoid arthritis 122.12 16.26 4 35034 253815 63200169
Toxicity to various agents 118.58 16.26 4 35034 247246 63206738
Fatigue 116.27 16.26 861 34177 887167 62566817
Joint swelling 114.98 16.26 21 35017 327645 63126339
Oropharyngeal pain 113.32 16.26 194 34844 94293 63359691
Relapsing multiple sclerosis 111.70 16.26 25 35013 167 63453817
Muscular weakness 108.90 16.26 221 34817 122132 63331852
Lymphopenia 108.27 16.26 86 34952 18241 63435743
Hypoaesthesia 103.94 16.26 263 34775 168130 63285854
Magnetic resonance imaging abnormal 100.82 16.26 44 34994 3041 63450943
Optic neuritis 93 16.26 58 34980 8377 63445607
Genital herpes 91.60 16.26 35 35003 1717 63452267
Throat tightness 91.13 16.26 89 34949 24798 63429186
Product use issue 86.89 16.26 10 35028 220510 63233474
Systemic lupus erythematosus 86.12 16.26 8 35030 208910 63245074
Glossodynia 85.37 16.26 3 35035 178873 63275111
Pregnancy 82.94 16.26 102 34936 36734 63417250
Invasive ductal breast carcinoma 82.20 16.26 50 34988 6908 63447076
Acute kidney injury 76.57 16.26 25 35013 263390 63190594
Blood immunoglobulin M decreased 75.03 16.26 26 35012 962 63453022
Abdominal discomfort 73.48 16.26 43 34995 320842 63133142
Exposure during pregnancy 72.88 16.26 3 35035 155544 63298440
Cystitis noninfective 70.82 16.26 25 35013 978 63453006
Arthropathy 70.53 16.26 21 35017 234771 63219213
Neuralgia 70.35 16.26 79 34959 25847 63428137
Product dose omission issue 70.31 16.26 21 35017 234292 63219692
Cystitis 66.00 16.26 113 34925 54878 63399106
Condition aggravated 64.82 16.26 76 34962 402141 63051843
Diarrhoea 64.26 16.26 193 34845 715173 62738811
Treatment failure 63.15 16.26 16 35022 199027 63254957
Balance disorder 62.97 16.26 142 34896 84280 63369704
Papilloma viral infection 59.93 16.26 25 35013 1545 63452439
Injection site pain 56.16 16.26 4 35034 129796 63324188
Swelling 56.13 16.26 42 34996 275336 63178648
Cough 55.89 16.26 313 34725 292430 63161554
Anaemia 54.55 16.26 49 34989 293381 63160603
Memory impairment 54.30 16.26 153 34885 104105 63349879
Drug interaction 53.43 16.26 30 35008 229101 63224883
Hepatic enzyme increased 52.43 16.26 23 35015 202305 63251679
Drug intolerance 52.23 16.26 56 34982 308605 63145379
Blood immunoglobulin G decreased 52.15 16.26 26 35012 2432 63451552
Asthenia 52.07 16.26 376 34662 383228 63070756
Hemiparesis 51.65 16.26 64 34974 23218 63430766
Paraesthesia 50.84 16.26 196 34842 156770 63297214
Thrombocytopenia 50.21 16.26 11 35027 151146 63302838
Wound 50.12 16.26 14 35024 163249 63290735
Lymphocyte count decreased 49.96 16.26 72 34966 30185 63423799
Urinary incontinence 49.71 16.26 74 34964 31940 63422044
Pericarditis 49.30 16.26 7 35031 131572 63322412
Flushing 49.12 16.26 120 34918 74967 63379017
Sensory disturbance 48.38 16.26 48 34990 13624 63440360
Pruritus 47.15 16.26 351 34687 361102 63092882
Product use in unapproved indication 46.97 16.26 20 35018 179060 63274924
General physical health deterioration 46.04 16.26 27 35011 201375 63252609
Abdominal pain 45.59 16.26 57 34981 293399 63160585
Therapeutic product effect decreased 42.62 16.26 27 35011 193160 63260824
Suspected COVID-19 42.57 16.26 23 35015 2539 63451445
Headache 42.37 16.26 534 34504 632707 62821277
Decreased vibratory sense 42.32 16.26 13 35025 326 63453658
Haemoglobin decreased 41.90 16.26 14 35024 145471 63308513
Therapeutic product effect incomplete 41.73 16.26 9 35029 125047 63328937
Drug hypersensitivity 41.66 16.26 67 34971 310620 63143364
Maternal exposure timing unspecified 39.18 16.26 32 35006 7055 63446929
Feeling hot 38.99 16.26 86 34952 50268 63403716
Demyelination 37.74 16.26 31 35007 6889 63447095
Pharyngeal swelling 37.71 16.26 30 35008 6374 63447610
Blood creatinine increased 37.16 16.26 3 35035 87841 63366143
Vomiting 37.02 16.26 171 34867 559446 62894538
Pyelonephritis 36.46 16.26 47 34991 17731 63436253
Psoriatic arthropathy 36.40 16.26 4 35034 91516 63362468
Arthralgia 35.99 16.26 177 34861 569533 62884451
Upper respiratory tract infection 35.69 16.26 113 34925 81934 63372050
Platelet count decreased 35.55 16.26 10 35028 116112 63337872
Muscle spasms 35.26 16.26 175 34863 155975 63298009
B-lymphocyte count increased 35.13 16.26 9 35029 113 63453871
Helicobacter infection 34.60 16.26 5 35033 92780 63361204
Rhinorrhoea 33.90 16.26 96 34942 65481 63388503
Hypokalaemia 33.57 16.26 8 35030 103796 63350188
Varicella virus test positive 32.76 16.26 9 35029 150 63453834
Renal impairment 32.40 16.26 5 35033 88350 63365634
Intentional product use issue 32.25 16.26 148 34890 127744 63326240
Cardiac failure congestive 32.20 16.26 6 35032 92427 63361557
Injection site erythema 32.17 16.26 4 35034 83170 63370814
Tandem gait test abnormal 31.78 16.26 7 35031 43 63453941
Immunodeficiency 31.70 16.26 47 34991 20207 63433777
Overdose 31.55 16.26 12 35026 115066 63338918
Oedema peripheral 31.34 16.26 35 35003 189476 63264508
Gastrointestinal haemorrhage 31.16 16.26 4 35034 81172 63372812
Oral pruritus 31.07 16.26 18 35020 2273 63451711
Ataxia 30.89 16.26 40 34998 15155 63438829
Hypogammaglobulinaemia 30.80 16.26 28 35010 7127 63446857
Vitamin D deficiency 30.51 16.26 38 35000 13854 63440130
Hyponatraemia 30.13 16.26 12 35026 111888 63342096
Influenza like illness 29.95 16.26 93 34945 66731 63387253
Neurogenic bladder 29.83 16.26 20 35018 3265 63450719
Hepatitis B virus test positive 29.79 16.26 9 35029 213 63453771
Vaginal infection 29.62 16.26 28 35010 7490 63446494
Illness 29.55 16.26 76 34962 48983 63405001
Abortion spontaneous 29.35 16.26 74 34964 47121 63406863
Peroneal nerve palsy 29.22 16.26 23 35015 4812 63449172
Limb discomfort 29.20 16.26 56 34982 29660 63424324
Lobular breast carcinoma in situ 28.96 16.26 7 35031 68 63453916
Trigeminal neuralgia 28.59 16.26 20 35018 3499 63450485
Human papilloma virus test positive 28.32 16.26 11 35027 564 63453420
Gastrointestinal infection 28.16 16.26 30 35008 9251 63444733
Severe acute respiratory syndrome 28.12 16.26 6 35032 31 63453953
Magnetic resonance imaging head abnormal 27.79 16.26 16 35022 1997 63451987
Dehydration 27.60 16.26 33 35005 173321 63280663
Micturition urgency 27.29 16.26 30 35008 9581 63444403
Arthritis 27.25 16.26 15 35023 115906 63338078
Perinatal stroke 27.03 16.26 5 35033 10 63453974
Urticaria 26.90 16.26 170 34868 165632 63288352
Hospitalisation 26.65 16.26 7 35031 85074 63368910
Infection susceptibility increased 26.27 16.26 19 35019 3502 63450482
Appendicitis 25.68 16.26 27 35011 8202 63445782
Immunoglobulins decreased 25.46 16.26 13 35025 1279 63452705
Renal failure 25.18 16.26 17 35021 117635 63336349
Blister 24.91 16.26 21 35017 129793 63324191
Stomatitis 24.76 16.26 24 35014 138701 63315283
Fibromyalgia 24.47 16.26 7 35031 80413 63373571
Discomfort 24.44 16.26 34 35004 167340 63286644
Peripheral swelling 24.29 16.26 71 34967 265871 63188113
Nausea 24.06 16.26 330 34708 854141 62599843
Therapeutic response shortened 23.71 16.26 31 35007 11857 63442127
Malignant melanoma 23.25 16.26 30 35008 11326 63442658
Cervical dysplasia 23.20 16.26 17 35021 3197 63450787
Liver injury 23.18 16.26 3 35035 60517 63393467
Decreased appetite 22.95 16.26 67 34971 250985 63202999
Pneumonia 22.74 16.26 366 34672 456401 62997583
Neuropathy peripheral 22.29 16.26 18 35020 113649 63340335
Anogenital warts 22.28 16.26 9 35029 512 63453472
Ophthalmic herpes zoster 22.21 16.26 14 35024 2059 63451925
Bladder disorder 22.14 16.26 26 35012 8920 63445064
Cervix carcinoma 21.78 16.26 16 35022 3021 63450963
Cardiac failure 21.74 16.26 11 35027 89131 63364853
Impaired healing 21.70 16.26 15 35023 102527 63351457
Central nervous system lesion 21.63 16.26 28 35010 10607 63443377
Magnetic resonance imaging spinal abnormal 21.35 16.26 7 35031 218 63453766
Sepsis 21.22 16.26 151 34887 152972 63301012
Injury 21.17 16.26 7 35031 73240 63380744
Urosepsis 20.83 16.26 37 35001 18487 63435497
Immunosuppression 20.79 16.26 25 35013 8789 63445195
Kidney infection 20.74 16.26 42 34996 23134 63430850
Agranulocytosis 20.68 16.26 44 34994 25090 63428894
Cardio-respiratory arrest 20.65 16.26 4 35034 59955 63394029
Irritable bowel syndrome 20.35 16.26 10 35028 82402 63371582
Pharyngeal disorder 20.33 16.26 13 35025 1960 63452024
Nasal herpes 20.19 16.26 8 35030 433 63453551
Invasive breast carcinoma 20.11 16.26 9 35029 660 63453324
Acquired diaphragmatic eventration 19.99 16.26 8 35030 444 63453540
Migraine 19.99 16.26 111 34927 103235 63350749
Injection site reaction 19.96 16.26 4 35034 58520 63395464
Feeling abnormal 19.79 16.26 145 34893 148247 63305737
Liver disorder 19.77 16.26 3 35035 53684 63400300
Colitis 19.44 16.26 65 34973 48463 63405521
Lipoedema 19.42 16.26 7 35031 291 63453693
Pleural effusion 19.24 16.26 14 35024 93196 63360788
T-lymphocyte count decreased 19.02 16.26 7 35031 309 63453675
Infrapatellar fat pad inflammation 18.94 16.26 6 35032 167 63453817
Diplopia 18.90 16.26 41 34997 23687 63430297
Respiratory tract infection 18.83 16.26 58 34980 41425 63412559
Secondary progressive multiple sclerosis 18.79 16.26 11 35027 1416 63452568
Atrial fibrillation 18.78 16.26 22 35016 116614 63337370
Vulvovaginal mycotic infection 18.70 16.26 19 35019 5547 63448437
Unevaluable event 18.63 16.26 3 35035 51383 63402601
Loss of personal independence in daily activities 18.34 16.26 16 35022 97274 63356710
Cognitive disorder 18.29 16.26 70 34968 55745 63398239
Intercepted product storage error 18.22 16.26 5 35033 83 63453901
Candida infection 18.20 16.26 45 34993 28306 63425678
Cerebral disorder 18.10 16.26 17 35021 4509 63449475
Fungal infection 18.10 16.26 53 34985 36821 63417163
B-lymphocyte abnormalities 18.05 16.26 5 35033 86 63453898
Ear discomfort 17.96 16.26 22 35016 7884 63446100
Intraductal proliferative breast lesion 17.78 16.26 14 35024 2931 63451053
Oropharyngeal discomfort 17.75 16.26 18 35020 5242 63448742
Invasive lobular breast carcinoma 17.62 16.26 9 35029 886 63453098
Product temperature excursion issue 17.58 16.26 6 35032 212 63453772
West Nile viral infection 17.40 16.26 7 35031 394 63453590
Progressive multifocal leukoencephalopathy 17.35 16.26 28 35010 12943 63441041
Automatic bladder 17.21 16.26 5 35033 103 63453881
Liver function test abnormal 17.05 16.26 3 35035 48178 63405806
Hypotension 16.98 16.26 85 34953 272519 63181465
Hypoglycaemia 16.90 16.26 6 35032 60059 63393925
Disease progression 16.87 16.26 26 35012 122732 63331252
Vulvovaginal candidiasis 16.85 16.26 14 35024 3161 63450823
Speech disorder 16.79 16.26 55 34983 40574 63413410
Blood pressure systolic increased 16.67 16.26 3 35035 47394 63406590
Folliculitis 16.67 16.26 9 35029 70308 63383676
Breast abscess 16.58 16.26 11 35027 1765 63452219
Borrelia infection 16.52 16.26 6 35032 255 63453729
Confusional state 16.31 16.26 71 34967 236309 63217675
Pulmonary oedema 16.29 16.26 5 35033 54868 63399116

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 2700.94 21.28 998 10826 76552 34868555
Multiple sclerosis relapse 529.52 21.28 190 11634 12943 34932164
Multiple sclerosis 380.19 21.28 125 11699 6520 34938587
Urinary tract infection 368.60 21.28 270 11554 83811 34861296
JC polyomavirus test positive 223.56 21.28 51 11773 646 34944461
SARS-CoV-2 test positive 220.80 21.28 81 11743 5852 34939255
Infusion related reaction 211.05 21.28 161 11663 52896 34892211
COVID-19 pneumonia 183.35 21.28 97 11727 16870 34928237
Herpes zoster 153.68 21.28 112 11712 34287 34910820
Throat irritation 144.87 21.28 71 11753 10514 34934593
Nasopharyngitis 115.60 21.28 130 11694 69838 34875269
Influenza 111.99 21.28 109 11715 49557 34895550
Muscular weakness 107.92 21.28 128 11696 72769 34872338
Gait disturbance 92.16 21.28 128 11696 85012 34860095
SARS-CoV-2 antibody test negative 82.20 21.28 14 11810 29 34945078
Urosepsis 81.69 21.28 52 11772 12747 34932360
Magnetic resonance imaging abnormal 78.23 21.28 27 11797 1629 34943478
Balance disorder 66.14 21.28 75 11749 40579 34904528
Acute kidney injury 65.70 21.28 12 11812 304976 34640131
Pruritus 63.65 21.28 145 11679 141836 34803271
Blood immunoglobulin M decreased 62.10 21.28 17 11807 467 34944640
B-lymphocyte count decreased 61.72 21.28 18 11806 625 34944482
Coronavirus infection 59.23 21.28 29 11795 4278 34940829
Ear pruritus 56.73 21.28 15 11809 360 34944747
No adverse event 56.71 21.28 53 11771 22874 34922233
Toxicity to various agents 55.60 21.28 3 11821 200359 34744748
Blood immunoglobulin G decreased 54.36 21.28 20 11804 1453 34943654
Lymphopenia 52.88 21.28 44 11780 16291 34928816
Muscle spasticity 50.70 21.28 29 11795 5859 34939248
Oral herpes 49.59 21.28 28 11796 5519 34939588
Cystitis 46.30 21.28 33 11791 9732 34935375
Anaemia 44.51 21.28 12 11812 233323 34711784
Fatigue 44.45 21.28 244 11580 370409 34574698
Drug interaction 44.28 21.28 11 11813 225935 34719172
Hypoaesthesia 39.61 21.28 73 11751 61371 34883736
Diarrhoea 37.75 21.28 46 11778 389866 34555241
Breast cancer 36.38 21.28 10 11814 279 34944828
Infection 35.41 21.28 88 11736 90827 34854280
Antibody test negative 35.04 21.28 6 11818 13 34945094
Urinary incontinence 34.44 21.28 37 11787 18837 34926270
Cellulitis 32.98 21.28 62 11762 52889 34892218
Urticaria 32.77 21.28 68 11756 62309 34882798
Sensory disturbance 31.90 21.28 22 11802 6155 34938952
B-lymphocyte count increased 30.44 21.28 6 11818 35 34945072
Asthenia 30.33 21.28 163 11661 245088 34700019
Memory impairment 29.86 21.28 53 11771 43265 34901842
Thrombocytopenia 29.83 21.28 8 11816 156239 34788868
Vaccination failure 29.59 21.28 12 11812 1134 34943973
Mobility decreased 29.15 21.28 43 11781 30085 34915022
Relapsing multiple sclerosis 27.97 21.28 4 11820 0 34945107
Progressive multiple sclerosis 27.96 21.28 8 11816 259 34944848
Haemoglobin decreased 27.61 21.28 4 11820 120768 34824339
Disability 27.06 21.28 18 11806 4747 34940360
Product use in unapproved indication 26.61 21.28 4 11820 117495 34827612
Fall 26.54 21.28 137 11687 202748 34742359
Decreased appetite 25.82 21.28 12 11812 166380 34778727
Demyelination 25.43 21.28 15 11809 3206 34941901
Migraine 24.66 21.28 30 11794 17448 34927659
Oropharyngeal pain 23.92 21.28 43 11781 35442 34909665
Hemiparesis 23.77 21.28 28 11796 15750 34929357
Rectal polyp 23.75 21.28 9 11815 710 34944397
Intentional product use issue 23.38 21.28 58 11766 59758 34885349
Immunoglobulins decreased 23.18 21.28 9 11815 758 34944349
Product dose omission issue 23.09 21.28 6 11818 119705 34825402
Neuralgia 23.07 21.28 27 11797 15086 34930021
Magnetic resonance imaging spinal abnormal 22.81 21.28 6 11818 141 34944966
Dehydration 22.39 21.28 8 11816 129961 34815146
Expanded disability status scale score increased 21.94 21.28 7 11817 330 34944777
Muscle spasms 21.59 21.28 65 11759 74936 34870171
Optic neuritis 21.51 21.28 14 11810 3560 34941547
Neurogenic bladder 21.37 21.28 11 11813 1802 34943305
Hypogammaglobulinaemia 21.29 21.28 19 11805 7721 34937386

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 5929.81 16.60 2310 32784 155364 79553930
Multiple sclerosis relapse 920.36 16.60 436 34658 46097 79663197
Infusion related reaction 751.62 16.60 696 34398 229541 79479753
Throat irritation 690.06 16.60 344 34750 40602 79668692
Urinary tract infection 637.79 16.60 690 34404 273822 79435472
Multiple sclerosis 599.62 16.60 259 34835 22023 79687271
SARS-CoV-2 test positive 429.80 16.60 170 34924 11546 79697748
COVID-19 pneumonia 426.55 16.60 222 34872 28627 79680667
Herpes zoster 371.65 16.60 316 34778 92767 79616527
Coronavirus infection 296.87 16.60 115 34979 7382 79701912
Nasopharyngitis 262.70 16.60 430 34664 253451 79455843
Oral herpes 252.89 16.60 155 34939 27299 79681995
JC polyomavirus test positive 252.64 16.60 70 35024 1532 79707762
B-lymphocyte count decreased 223.97 16.60 62 35032 1352 79707942
Influenza 210.59 16.60 272 34822 129334 79579960
Ear pruritus 198.74 16.60 73 35021 4042 79705252
SARS-CoV-2 antibody test negative 197.93 16.60 40 35054 198 79709096
Fatigue 177.53 16.60 842 34252 928885 78780409
Muscle spasticity 169.58 16.60 110 34984 21365 79687929
Gait disturbance 168.32 16.60 316 34778 207190 79502104
Maternal exposure before pregnancy 165.76 16.60 65 35029 4308 79704986
Breast cancer 160.47 16.60 127 34967 33654 79675640
Toxicity to various agents 156.03 16.60 7 35087 421533 79287761
Oropharyngeal pain 144.95 16.60 208 34886 109145 79600149
Muscular weakness 139.37 16.60 252 34842 160477 79548817
Hypoaesthesia 132.96 16.60 263 34831 179089 79530205
Acute kidney injury 132.26 16.60 33 35061 519371 79189923
Lymphopenia 110.19 16.60 98 34996 30459 79678835
Magnetic resonance imaging abnormal 102.21 16.60 43 35051 3416 79705878
Herpes virus infection 94.92 16.60 51 35043 6998 79702296
Optic neuritis 90.84 16.60 55 35039 9465 79699829
Throat tightness 89.86 16.60 84 35010 27823 79681471
Drug interaction 88.54 16.60 36 35058 415147 79294147
Completed suicide 87.94 16.60 5 35089 245762 79463532
Balance disorder 85.62 16.60 155 34939 98702 79610592
Relapsing multiple sclerosis 84.00 16.60 18 35076 124 79709170
Anaemia 83.53 16.60 46 35048 444969 79264325
Drug ineffective 82.39 16.60 226 34868 1080687 78628607
Headache 81.11 16.60 528 34566 653244 79056050
Sensory disturbance 81.01 16.60 61 35033 15016 79694278
Thrombocytopenia 79.91 16.60 11 35083 265248 79444046
Condition aggravated 78.96 16.60 63 35031 501061 79208233
Pruritus 77.32 16.60 361 34733 394287 79315007
Rheumatoid arthritis 75.32 16.60 4 35090 208466 79500828
Invasive ductal breast carcinoma 74.81 16.60 41 35053 5851 79703443
Memory impairment 74.60 16.60 157 34937 111577 79597717
Cystitis 73.80 16.60 103 34991 52629 79656665
Genital herpes 72.09 16.60 29 35065 2055 79707239
Product dose omission issue 70.60 16.60 12 35082 247525 79461769
Blood immunoglobulin M decreased 69.85 16.60 25 35069 1284 79708010
Cystitis noninfective 69.27 16.60 25 35069 1315 79707979
Diarrhoea 66.30 16.60 185 34909 880304 78828990
Neuralgia 65.30 16.60 77 35017 33307 79675987
Joint swelling 64.88 16.60 23 35071 288623 79420671
Product use issue 64.87 16.60 8 35086 209814 79499480
Asthenia 63.19 16.60 413 34681 511276 79198018
Product use in unapproved indication 61.53 16.60 17 35077 250342 79458952
Haemoglobin decreased 60.69 16.60 12 35082 222107 79487187
Urinary incontinence 60.39 16.60 82 35012 40827 79668467
Urosepsis 60.11 16.60 66 35028 26429 79682865
Cough 58.03 16.60 316 34778 366473 79342821
Paraesthesia 54.37 16.60 186 34908 176137 79533157
Influenza like illness 54.07 16.60 106 34988 71601 79637693
Treatment failure 53.94 16.60 6 35088 170480 79538814
Upper respiratory tract infection 53.90 16.60 122 34972 91046 79618248
Oedema peripheral 53.53 16.60 22 35072 252266 79457028
Papilloma viral infection 52.72 16.60 22 35072 1712 79707582
Renal impairment 51.34 16.60 5 35089 157778 79551516
Blood immunoglobulin G decreased 49.67 16.60 26 35068 3383 79705911
Muscle spasms 48.44 16.60 178 34916 174552 79534742
Platelet count decreased 48.23 16.60 13 35081 194651 79514643
Rhinorrhoea 47.43 16.60 104 34990 75970 79633324
Therapeutic product effect incomplete 47.40 16.60 4 35090 141641 79567653
Gastrointestinal haemorrhage 47.23 16.60 5 35089 147714 79561580
Abdominal pain 45.54 16.60 63 35031 389506 79319788
General physical health deterioration 44.04 16.60 34 35060 275204 79434090
Injection site pain 42.54 16.60 4 35090 129834 79579460
Lymphocyte count decreased 42.00 16.60 75 35019 47214 79662080
Drug intolerance 41.78 16.60 33 35061 264086 79445208
Feeling hot 41.09 16.60 85 35009 59649 79649645
Blood creatinine increased 41.06 16.60 9 35085 155048 79554246
Cardiac failure congestive 40.37 16.60 7 35087 142395 79566899
Illness 40.33 16.60 73 35021 46438 79662856
Hyponatraemia 40.23 16.60 14 35080 177834 79531460
Limb discomfort 39.88 16.60 60 35034 32790 79676504
Overdose 39.16 16.60 16 35078 184190 79525104
Systemic lupus erythematosus 38.99 16.60 4 35090 121145 79588149
Immunodeficiency 38.96 16.60 48 35046 21720 79687574
Flushing 38.32 16.60 105 34989 88163 79621131
Arthropathy 38.28 16.60 15 35079 177096 79532198
Hypogammaglobulinaemia 37.92 16.60 37 35057 12914 79696380
Migraine 37.90 16.60 104 34990 87389 79621905
Trigeminal neuralgia 37.42 16.60 22 35072 3587 79705707
Hepatic enzyme increased 37.01 16.60 17 35077 182593 79526701
Hypokalaemia 36.86 16.60 9 35085 144031 79565263
Vaginal infection 36.59 16.60 26 35068 5854 79703440
Hemiparesis 34.56 16.60 57 35037 33676 79675618
Dehydration 34.47 16.60 35 35059 248152 79461142
Hyperkalaemia 33.83 16.60 5 35089 114393 79594901
Oral pruritus 33.77 16.60 18 35076 2430 79706864
Decreased appetite 33.74 16.60 62 35032 342356 79366938
Peroneal nerve palsy 33.69 16.60 25 35069 6017 79703277
Decreased vibratory sense 32.72 16.60 12 35082 661 79708633
Visual impairment 32.70 16.60 102 34992 92029 79617265
Pharyngeal swelling 32.38 16.60 27 35067 7692 79701602
Ophthalmic herpes zoster 32.22 16.60 18 35076 2666 79706628
Gastrointestinal infection 32.18 16.60 32 35062 11429 79697865
Lobular breast carcinoma in situ 31.97 16.60 7 35087 54 79709240
No adverse event 31.77 16.60 58 35036 37134 79672160
Cardio-respiratory arrest 31.50 16.60 5 35089 108505 79600789
Feeling abnormal 30.61 16.60 145 34949 159054 79550240
Malignant melanoma 30.49 16.60 35 35059 14706 79694588
Urticaria 30.20 16.60 161 34933 185040 79524254
Progressive multifocal leukoencephalopathy 29.95 16.60 41 35053 20559 79688735
Fall 29.91 16.60 337 34757 487292 79222002
Vaccination failure 29.50 16.60 15 35079 1838 79707456
Renal failure 29.46 16.60 27 35067 200941 79508353
Neurogenic bladder 29.43 16.60 20 35074 4192 79705102
Hypoxia 29.42 16.60 5 35089 103238 79606056
Progressive multiple sclerosis 29.00 16.60 13 35081 1204 79708090
Therapeutic response shortened 28.42 16.60 35 35059 15828 79693466
Immunisation reaction 28.35 16.60 10 35084 492 79708802
Death 28.12 16.60 141 34953 566373 79142921
Vomiting 27.50 16.60 176 34918 665652 79043642
Pyelonephritis 27.29 16.60 39 35055 20349 79688945
Secondary progressive multiple sclerosis 27.29 16.60 13 35081 1384 79707910
Rhabdomyolysis 27.27 16.60 6 35088 103125 79606169
Suspected COVID-19 27.09 16.60 17 35077 3116 79706178
Disease progression 26.75 16.60 25 35069 184337 79524957
Intentional product use issue 26.70 16.60 135 34959 151977 79557317
Hypoglycaemia 26.68 16.60 6 35088 101588 79607706
Magnetic resonance imaging head abnormal 26.65 16.60 16 35078 2710 79706584
Abortion spontaneous 26.46 16.60 47 35047 29460 79679834
Aspartate aminotransferase increased 26.44 16.60 14 35080 138627 79570667
Paraparesis 26.43 16.60 18 35076 3785 79705509
Vitamin D deficiency 26.38 16.60 32 35062 14247 79695047
Multiple organ dysfunction syndrome 26.28 16.60 10 35084 120236 79589058
Atrial fibrillation 26.25 16.60 29 35065 197857 79511437
Immunoglobulins decreased 25.92 16.60 13 35081 1547 79707747
Severe acute respiratory syndrome 25.85 16.60 7 35087 140 79709154
Immunosuppression 25.81 16.60 30 35064 12773 79696521
Hypotension 25.80 16.60 103 34991 440214 79269080
Cardiac failure 24.91 16.60 19 35075 154823 79554471
Bladder disorder 24.65 16.60 25 35069 9140 79700154
Depression 24.27 16.60 171 34923 216619 79492675
Cervix carcinoma 24.06 16.60 14 35080 2239 79707055
Psoriatic arthropathy 24.03 16.60 3 35091 77996 79631298
Hospitalisation 23.89 16.60 6 35088 94230 79615064
Ascites 23.05 16.60 3 35091 75559 79633735
Lipoedema 23.00 16.60 7 35087 215 79709079
Drug hypersensitivity 22.98 16.60 62 35032 298854 79410440
Vaccination complication 22.98 16.60 10 35084 863 79708431
Bronchitis 22.96 16.60 116 34978 130528 79578766
Magnetic resonance imaging spinal abnormal 22.64 16.60 7 35087 227 79709067
Febrile neutropenia 22.58 16.60 42 35052 230957 79478337
Heart rate increased 22.50 16.60 109 34985 120615 79588679
Abdominal discomfort 22.44 16.60 48 35046 250679 79458615
Borrelia infection 21.99 16.60 7 35087 250 79709044
Cervical dysplasia 21.95 16.60 13 35081 2148 79707146
Pleural effusion 21.90 16.60 19 35075 145243 79564051
Oxygen saturation decreased 21.85 16.60 15 35079 129032 79580262
Injection site erythema 21.82 16.60 4 35090 78193 79631101
Burning sensation 21.81 16.60 66 35028 58566 79650728
Pneumonia 21.60 16.60 409 34685 659837 79049457
Alanine aminotransferase increased 21.36 16.60 24 35070 162546 79546748
Depressed level of consciousness 21.19 16.60 8 35086 96644 79612650
B-lymphocyte count increased 21.09 16.60 6 35088 145 79709149
Breast abscess 20.84 16.60 11 35083 1455 79707839
Initial insomnia 20.65 16.60 20 35074 6918 79702376
Sensory loss 20.64 16.60 27 35067 12964 79696330
Infrapatellar fat pad inflammation 20.28 16.60 6 35088 167 79709127
Selective IgG subclass deficiency 20.11 16.60 4 35090 18 79709276
Central nervous system lesion 20.03 16.60 27 35067 13341 79695953
Demyelination 19.98 16.60 21 35073 8002 79701292
Hepatic function abnormal 19.85 16.60 4 35090 73103 79636191
Swelling 19.80 16.60 41 35053 216670 79492624
Liver disorder 19.58 16.60 4 35090 72413 79636881
Salpingitis 19.57 16.60 6 35088 189 79709105
Anogenital warts 19.19 16.60 9 35085 925 79708369
Varicella virus test positive 19.13 16.60 6 35088 204 79709090
Electrocardiogram QT prolonged 18.96 16.60 8 35086 90378 79618916
Cardiac arrest 18.93 16.60 29 35065 172067 79537227
Acquired diaphragmatic eventration 18.84 16.60 8 35086 650 79708644
Oedema 18.82 16.60 15 35079 119565 79589729
Appendicitis 18.49 16.60 33 35061 20761 79688533
Micturition urgency 18.14 16.60 25 35069 12616 79696678
Acne pustular 18.06 16.60 6 35088 246 79709048
Dyspnoea exertional 17.80 16.60 8 35086 87065 79622229
Pericarditis 17.80 16.60 12 35082 104224 79605070
Occipital neuralgia 17.77 16.60 7 35087 469 79708825
Infection susceptibility increased 17.68 16.60 14 35080 3707 79705587
Ataxia 17.65 16.60 36 35058 25003 79684291
Hyperpathia 17.65 16.60 3 35091 4 79709290
Disability 17.63 16.60 29 35065 17091 79692203
Neuropathy peripheral 17.35 16.60 22 35072 141283 79568011
Vulvovaginal mycotic infection 17.17 16.60 15 35079 4551 79704743
Invasive breast carcinoma 16.92 16.60 7 35087 533 79708761
Middle ear inflammation 16.91 16.60 4 35090 45 79709249
Respiratory failure 16.72 16.60 34 35060 180877 79528417
Interstitial lung disease 16.65 16.60 15 35079 112585 79596709
Coma 16.64 16.60 12 35082 100637 79608657
Helicobacter infection 16.62 16.60 5 35089 69699 79639595

FDA Adverse Event Reporting System (Pediatric)

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
Perinatal stroke 26.42 20.71 4 10 11 89767

Pharmacologic Action:

SourceCodeDescription
ATC L04AA36 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
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

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
CHEMBL2108041 ChEMBL_ID
DB11988 DRUGBANK_ID
D05218 KEGG_DRUG
8636 INN_ID
7580 IUPHAR_LIGAND_ID
254931 MMSL
32532 MMSL
d08538 MMSL
017151 NDDF
733464008 SNOMEDCT_US
763559000 SNOMEDCT_US
1876366 RXNORM
C533411 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
OCREVUS HUMAN PRESCRIPTION DRUG LABEL 1 50242-150 INJECTION 300 mg INTRAVENOUS BLA 29 sections
OCREVUS HUMAN PRESCRIPTION DRUG LABEL 1 50242-150 INJECTION 300 mg INTRAVENOUS BLA 29 sections
OCREVUS HUMAN PRESCRIPTION DRUG LABEL 1 50242-150 INJECTION 300 mg INTRAVENOUS BLA 29 sections