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

Stem definitionDrug idCAS RN
humanized origin 4970 189261-10-7

Description:

MoleculeDescription

Synonyms:

  • antegren
  • natalizumab
  • tysabri
A humanized monoclonal immunoglobulin G4 antibody to human INTEGRIN ALPHA4 that binds to the alpha4 subunit of INTEGRIN ALPHA4BETA1 and integrin alpha4beta7. It is used as an IMMUNOLOGIC FACTOR in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS and CROHN'S DISEASE.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
10 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
Nov. 23, 2004 FDA BIOGEN IDEC
June 27, 2006 EMA Biogen Netherlands B.V.

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
Multiple sclerosis relapse 14588.06 12.86 4418 102866 47887 90473276
Progressive multifocal leukoencephalopathy 4217.94 12.86 1292 105992 14363 90506800
Immune reconstitution inflammatory syndrome 2860.49 12.86 799 106485 6220 90514943
Urinary tract infection 2110.79 12.86 2179 105105 303453 90217710
Abortion spontaneous 1483.24 12.86 876 106408 53180 90467983
Opportunistic infection 1242.95 12.86 324 106960 1869 90519294
Malaise 1185.90 12.86 2319 104965 583667 89937496
Drug specific antibody present 1179.70 12.86 382 106902 5132 90516031
General symptom 1158.33 12.86 488 106796 14180 90506983
Balance disorder 821.14 12.86 775 106509 96305 90424858
Poor venous access 769.88 12.86 402 106882 19125 90502038
Fall 737.38 12.86 1704 105580 480106 90041057
Prescribed underdose 708.30 12.86 637 106647 74382 90446781
Off label use 653.65 12.86 246 107038 1102006 89419157
Gait disturbance 615.37 12.86 1104 106180 259392 90261771
Central nervous system lesion 607.54 12.86 290 106994 11356 90509807
Seizure 605.95 12.86 822 106462 151807 90369356
Cognitive disorder 592.24 12.86 557 106727 68850 90452313
Neoplasm malignant 551.49 12.86 396 106888 33484 90487679
Caesarean section 543.24 12.86 314 106970 18263 90502900
Magnetic resonance imaging abnormal 526.62 12.86 186 107098 3300 90517863
Breast cancer 504.36 12.86 455 106829 53306 90467857
Maternal exposure during pregnancy 502.79 12.86 1230 106054 358833 90162330
Herpes zoster 499.94 12.86 588 106696 94056 90427107
Secondary progressive multiple sclerosis 457.60 12.86 138 107146 1441 90519722
Loss of control of legs 438.67 12.86 131 107153 1319 90519844
Pemphigus 370.04 12.86 3 107281 326861 90194302
Joint swelling 364.56 12.86 76 107208 503224 90017939
Glossodynia 350.67 12.86 6 107278 321773 90199390
Optic neuritis 346.81 12.86 187 107097 9491 90511672
Contraindicated product administered 333.26 12.86 10 107274 320129 90201034
Memory impairment 332.20 12.86 726 106558 196518 90324645
Invasive ductal breast carcinoma 319.70 12.86 165 107119 7653 90513510
Decubitus ulcer 312.05 12.86 187 107097 11626 90509537
Product use issue 305.90 12.86 22 107262 329897 90191266
Product use in unapproved indication 304.49 12.86 25 107259 336211 90184952
Rheumatoid arthritis 290.33 12.86 42 107242 362572 90158591
Condition aggravated 290.27 12.86 173 107111 595372 89925791
Muscular weakness 288.93 12.86 707 106577 205959 90315204
JC polyomavirus test positive 286.93 12.86 100 107184 1702 90519461
Diarrhoea 280.31 12.86 425 106859 938765 89582398
Systemic lupus erythematosus 278.22 12.86 47 107237 361849 90159314
Abdominal discomfort 267.92 12.86 115 107169 477213 90043950
Death 267.45 12.86 1159 106125 455392 90065771
Neutralising antibodies positive 256.52 12.86 63 107221 273 90520890
Musculoskeletal disorder 254.39 12.86 209 107075 21560 90499603
Psoriatic arthropathy 254.13 12.86 3 107281 228332 90292831
Asthenia 251.79 12.86 1272 106012 532479 89988684
Muscle spasticity 248.08 12.86 255 107029 35067 90486096
Pericarditis 244.78 12.86 20 107264 270131 90251032
Drug hypersensitivity 241.21 12.86 124 107160 463485 90057678
Influenza 239.35 12.86 517 106767 138747 90382416
Peripheral swelling 237.45 12.86 96 107188 413010 90108153
Toxicity to various agents 233.50 12.86 32 107252 287814 90233349
Helicobacter infection 232.75 12.86 8 107276 226842 90294321
Malignant melanoma 223.13 12.86 155 107129 12421 90508742
Alopecia 219.19 12.86 160 107124 494911 90026252
Multiple sclerosis 212.01 12.86 210 107074 27630 90493533
Drug delivery device placement 211.38 12.86 45 107239 83 90521080
Stress 205.93 12.86 356 106928 81039 90440124
Drug interaction 203.57 12.86 40 107244 276413 90244750
Trigeminal neuralgia 200.71 12.86 98 107186 4033 90517130
Cystitis 200.01 12.86 315 106969 66403 90454760
Stomatitis 197.59 12.86 42 107242 274656 90246507
Folliculitis 194.11 12.86 12 107272 204341 90316822
Muscle injury 193.59 12.86 3 107281 176651 90344512
Neurogenic bladder 193.06 12.86 92 107192 3586 90517577
Peroneal nerve palsy 191.91 12.86 106 107178 5642 90515521
Arthropathy 191.84 12.86 97 107187 366145 90155018
Weight increased 191.61 12.86 130 107154 417797 90103366
Swelling 189.93 12.86 132 107152 418926 90102237
Blister 181.34 12.86 40 107244 254958 90266205
Progressive multiple sclerosis 180.17 12.86 65 107219 1229 90519934
Surgery 179.71 12.86 243 107041 44644 90476519
Hysterectomy 176.17 12.86 130 107154 11454 90509709
Hemiparesis 175.05 12.86 202 107082 31617 90489546
Decreased appetite 172.75 12.86 117 107167 376423 90144740
Arthralgia 167.24 12.86 427 106857 778095 89743068
Lower respiratory tract infection 167.14 12.86 45 107239 250614 90270549
Visual impairment 166.22 12.86 435 106849 131930 90389233
C-reactive protein increased 162.69 12.86 14 107270 181375 90339788
Drug intolerance 162.69 12.86 174 107110 447417 90073746
Mental impairment 161.63 12.86 144 107140 16576 90504587
Intentional product use issue 160.45 12.86 31 107253 216861 90304302
Wheezing 160.15 12.86 42 107242 238038 90283125
Injection site pain 159.70 12.86 12 107272 173687 90347476
Vein disorder 157.63 12.86 92 107192 5444 90515719
Febrile neutropenia 157.59 12.86 7 107277 158342 90362821
Neuromyelitis optica spectrum disorder 153.39 12.86 60 107224 1430 90519733
Breast cancer female 151.49 12.86 132 107152 14754 90506409
Exposure during pregnancy 149.45 12.86 48 107236 238362 90282801
Hypersensitivity 145.22 12.86 978 106306 453699 90067464
Ankle fracture 144.72 12.86 148 107136 20222 90500941
Irritable bowel syndrome 144.56 12.86 34 107250 207414 90313749
Urosepsis 143.17 12.86 150 107134 21082 90500081
Hypoaesthesia 142.31 12.86 741 106543 313469 90207694
Neutropenia 141.47 12.86 45 107239 224859 90296304
Liver injury 140.56 12.86 18 107266 170549 90350614
Therapeutic product effect incomplete 136.65 12.86 31 107253 193865 90327298
Intraductal proliferative breast lesion 135.79 12.86 71 107213 3382 90517781
Fibromyalgia 135.68 12.86 38 107246 206231 90314932
Aphasia 135.08 12.86 207 107077 42605 90478558
Decreased immune responsiveness 134.89 12.86 99 107185 8649 90512514
Type 2 diabetes mellitus 134.52 12.86 37 107247 203207 90317956
Wound 133.83 12.86 98 107186 302882 90218281
Intervertebral disc protrusion 133.66 12.86 163 107121 27033 90494130
Acute kidney injury 133.45 12.86 110 107174 320277 90200886
Nasopharyngitis 132.55 12.86 880 106404 406224 90114939
Blood cholesterol increased 131.94 12.86 41 107243 207971 90313192
Speech disorder 130.79 12.86 211 107073 45374 90475789
Dyspepsia 129.43 12.86 37 107247 198123 90323040
Hip fracture 123.27 12.86 173 107111 32904 90488259
Injury 121.45 12.86 41 107243 197308 90323855
Discomfort 120.81 12.86 89 107195 274246 90246917
Dyspnoea 116.04 12.86 593 106691 880362 89640801
Rash 115.85 12.86 517 106767 795583 89725580
Bronchitis 114.76 12.86 420 106864 152507 90368656
Relapsing-remitting multiple sclerosis 114.49 12.86 41 107243 758 90520405
Inflammation 113.61 12.86 35 107249 178557 90342606
Bladder disorder 112.60 12.86 97 107187 10675 90510488
Cervical dysplasia 112.12 12.86 66 107218 3968 90517195
Sleep disorder 112.06 12.86 47 107237 197983 90323180
Dry mouth 111.94 12.86 39 107245 184020 90337143
Uterine leiomyoma 111.89 12.86 97 107187 10767 90510396
Hospitalisation 111.87 12.86 11 107273 128089 90393074
Joint range of motion decreased 110.11 12.86 15 107269 135628 90385535
Loss of personal independence in daily activities 108.26 12.86 16 107268 136089 90385074
Bursitis 108.21 12.86 14 107270 131640 90389523
Diplopia 106.74 12.86 150 107134 28564 90492599
Cervix carcinoma 106.71 12.86 60 107224 3306 90517857
Nephrolithiasis 106.65 12.86 201 107083 48884 90472279
Coordination abnormal 106.57 12.86 129 107155 21227 90499936
Breech presentation 106.18 12.86 44 107240 1223 90519940
Treatment failure 106.11 12.86 122 107162 303806 90217357
Urinary incontinence 103.86 12.86 171 107113 37395 90483768
Lip dry 101.98 12.86 4 107280 100951 90420212
Oedema 101.90 12.86 55 107229 200240 90320923
Vision blurred 101.22 12.86 324 106960 109969 90411194
Central venous catheterisation 100.28 12.86 54 107230 2732 90518431
Impaired healing 95.53 12.86 82 107202 234117 90287046
Thyroid cancer 94.38 12.86 70 107214 6214 90514949
Prolonged labour 93.59 12.86 33 107251 582 90520581
Ectopic pregnancy 92.65 12.86 54 107230 3187 90517976
Hypercholesterolaemia 92.64 12.86 7 107277 100885 90420278
Grip strength decreased 92.40 12.86 4 107280 92572 90428591
Anaphylactic shock 91.58 12.86 147 107137 31470 90489693
Mental disorder 90.54 12.86 148 107136 32170 90488993
Therapy non-responder 90.22 12.86 25 107259 136679 90384484
Lymphocytosis 88.50 12.86 51 107233 2946 90518217
Staphylococcal infection 87.95 12.86 184 107100 48255 90472908
Kidney infection 87.00 12.86 129 107155 25787 90495376
Psoriasis 85.31 12.86 34 107250 147720 90373443
Prescribed overdose 83.65 12.86 9 107275 97616 90423547
Infusion site extravasation 82.52 12.86 80 107204 10248 90510915
Pulmonary fibrosis 82.42 12.86 14 107270 107489 90413674
Injection site erythema 82.10 12.86 10 107274 98492 90422671
Hypertension 81.24 12.86 274 107010 457258 90063905
Red blood cell sedimentation rate increased 81.03 12.86 4 107280 82591 90438572
Night sweats 80.52 12.86 26 107258 128740 90392423
Tremor 80.45 12.86 377 106907 152796 90368367
Thrombocytopenia 80.44 12.86 77 107207 208648 90312515
Ataxia 80.44 12.86 103 107181 17939 90503224
Gastric bypass 80.10 12.86 42 107242 2012 90519151
Depression 79.85 12.86 619 106665 299982 90221181
JC virus granule cell neuronopathy 79.55 12.86 21 107263 128 90521035
Nausea 77.82 12.86 891 106393 1109425 89411738
White blood cell count increased 77.33 12.86 214 107070 67027 90454136
Temperature intolerance 74.07 12.86 81 107203 11949 90509214
Peripheral venous disease 73.82 12.86 7 107277 83914 90437249
Hepatic enzyme increased 73.31 12.86 203 107081 360533 90160630
Sensory disturbance 71.90 12.86 90 107194 15323 90505840
Dysgraphia 71.51 12.86 48 107236 3635 90517528
Post lumbar puncture syndrome 71.30 12.86 30 107254 867 90520296
Vomiting 70.94 12.86 595 106689 787698 89733465
Pancytopenia 70.54 12.86 27 107257 120236 90400927
Viral infection 70.21 12.86 153 107131 41261 90479902
Abdominal pain upper 70.01 12.86 184 107100 332490 90188673
Disease progression 69.96 12.86 50 107234 156565 90364598
Head injury 69.35 12.86 129 107155 31059 90490104
Herpes zoster necrotising retinopathy 68.88 12.86 12 107272 0 90521163
Focal dyscognitive seizures 68.41 12.86 44 107240 3100 90518063
Injection site reaction 68.40 12.86 13 107271 92067 90429096
Abdominal pain 68.18 12.86 240 107044 395481 90125682
Intentional product misuse 67.96 12.86 12 107272 89592 90431571
Osteoarthritis 66.74 12.86 80 107204 195650 90325513
Therapeutic response decreased 65.95 12.86 13 107271 89716 90431447
Dysstasia 65.19 12.86 111 107173 24941 90496222
Electrocardiogram QT prolonged 63.84 12.86 6 107278 72450 90448713
Cellulitis 63.62 12.86 245 107039 91092 90430071
Hyponatraemia 63.18 12.86 40 107244 133498 90387665
Ovarian cancer 62.87 12.86 57 107227 6710 90514453
Medication error 62.78 12.86 12 107272 84640 90436523
Papillary thyroid cancer 62.75 12.86 39 107245 2588 90518575
Breast cancer stage III 62.56 12.86 12 107272 84435 90436728
Upper respiratory tract infection 62.44 12.86 309 106975 128009 90393154
Intentional overdose 62.21 12.86 17 107267 93817 90427346
Lung adenocarcinoma 62.03 12.86 52 107232 5513 90515650
Pharyngitis streptococcal 62.00 12.86 76 107208 12666 90508497
Therapeutic product effect decreased 61.90 12.86 149 107135 277422 90243741
Escherichia urinary tract infection 61.80 12.86 79 107205 13736 90507427
Autoimmune disorder 61.07 12.86 9 107275 76735 90444428
Basal cell carcinoma 60.80 12.86 127 107157 33262 90487901
Upper limb fracture 60.69 12.86 99 107185 21479 90499684
Band sensation 60.52 12.86 29 107255 1144 90520019
Sepsis 59.77 12.86 391 106893 179423 90341740
Partial seizures 59.45 12.86 57 107227 7203 90513960
Clostridial infection 59.43 12.86 47 107237 4589 90516574
Appendicitis perforated 59.35 12.86 35 107249 2111 90519052
Fatigue 59.34 12.86 1785 105499 1152238 89368925
Blood creatinine increased 59.06 12.86 23 107261 101363 90419800
No adverse event 59.01 12.86 196 107088 67786 90453377
Gallbladder operation 58.37 12.86 38 107246 2733 90518430
Injection site swelling 58.37 12.86 3 107281 59836 90461327
Renal impairment 58.06 12.86 26 107258 105395 90415768
Wrong technique in product usage process 57.87 12.86 8 107276 71563 90449600
Delirium 57.06 12.86 26 107258 104333 90416830
Gastrooesophageal reflux disease 56.69 12.86 68 107216 166269 90354894
Platelet count decreased 55.77 12.86 48 107236 136921 90384242
Adenocarcinoma of colon 55.51 12.86 37 107247 2769 90518394
Leukopenia 55.21 12.86 25 107259 100685 90420478
Influenza like illness 55.14 12.86 215 107069 80396 90440767
Invasive lobular breast carcinoma 54.80 12.86 26 107258 1003 90520160
Asthma 53.98 12.86 130 107154 242030 90279133
Abortion missed 53.96 12.86 32 107252 1950 90519213
Expanded disability status scale score increased 53.88 12.86 24 107260 799 90520364
Chronic lymphocytic leukaemia 53.73 12.86 38 107246 3132 90518031
Meningioma 53.68 12.86 46 107238 5025 90516138
Lung disorder 53.53 12.86 59 107225 149824 90371339
Antibody test positive 53.39 12.86 37 107247 2952 90518211
Incorrect dose administered 52.89 12.86 14 107270 78916 90442247
Colon cancer 52.81 12.86 65 107219 10879 90510284
Neurological symptom 52.77 12.86 52 107232 6795 90514368
Frequent bowel movements 52.12 12.86 4 107280 56931 90464232
Flushing 51.83 12.86 225 107059 88266 90432897
Frustration tolerance decreased 51.83 12.86 55 107229 7841 90513322
Primary progressive multiple sclerosis 51.37 12.86 14 107270 98 90521065
Gastroenteritis viral 51.29 12.86 112 107172 30243 90490920
Mobility decreased 51.13 12.86 487 106797 250247 90270916
Dislocation of vertebra 51.04 12.86 4 107280 55964 90465199
Bipolar disorder 51.03 12.86 58 107226 8927 90512236
Meningitis herpes 49.98 12.86 17 107267 268 90520895
Pleural effusion 49.69 12.86 36 107248 111955 90409208
Feeling abnormal 49.24 12.86 353 106931 166882 90354281
Endometriosis 49.18 12.86 48 107236 6200 90514963
Weight decreased 49.09 12.86 257 107027 379653 90141510
Dysarthria 49.01 12.86 159 107125 54323 90466840
Cardiac failure 48.84 12.86 35 107249 109461 90411702
Ophthalmic herpes zoster 48.60 12.86 34 107250 2754 90518409
Vertigo 48.40 12.86 187 107097 69624 90451539
Atrial fibrillation 48.37 12.86 52 107232 133559 90387604
Neuropathy peripheral 47.73 12.86 55 107229 136915 90384248
Central nervous system lymphoma 47.67 12.86 30 107254 2035 90519128
Neutrophil count decreased 47.34 12.86 13 107271 71519 90449644
Foot fracture 47.05 12.86 100 107184 26506 90494657
Paraparesis 47 12.86 34 107250 2904 90518259
Muscle spasms 46.86 12.86 480 106804 251403 90269760
Adjustment disorder with depressed mood 46.71 12.86 6 107278 56747 90464416
Drug ineffective for unapproved indication 46.24 12.86 11 107273 66633 90454530
Pregnancy 46.16 12.86 170 107114 61877 90459286
General physical health deterioration 46.01 12.86 240 107044 354875 90166288
Foetal exposure timing unspecified 45.94 12.86 18 107266 431 90520732
Oxygen saturation decreased 45.82 12.86 36 107248 107447 90413716
Pneumonia aspiration 45.78 12.86 129 107155 40811 90480352
Relapsing multiple sclerosis 45.73 12.86 15 107269 210 90520953
Vaginal infection 45.44 12.86 53 107231 8387 90512776
Incorrect route of product administration 45.12 12.86 4 107280 50622 90470541
Dry skin 45.04 12.86 24 107260 88049 90433114
Hemianaesthesia 45.02 12.86 17 107267 367 90520796
Myelitis 45.01 12.86 29 107255 2049 90519114
Breast cancer in situ 44.54 12.86 27 107257 1713 90519450
Sciatica 44.44 12.86 33 107251 101349 90419814
Post procedural infection 44.38 12.86 60 107224 11014 90510149
Drug abuse 44.27 12.86 21 107263 82326 90438837
Multiple organ dysfunction syndrome 44.15 12.86 13 107271 68323 90452840
Malignant melanoma in situ 43.98 12.86 22 107262 954 90520209
Bladder dysfunction 43.88 12.86 23 107261 1101 90520062
Meningoencephalitis herpetic 43.54 12.86 25 107259 1434 90519729
Meningitis viral 43.52 12.86 26 107258 1606 90519557
Agraphia 43.33 12.86 10 107274 31 90521132
Rectal haemorrhage 43.12 12.86 22 107262 82722 90438441
Cholecystectomy 43.08 12.86 61 107223 11694 90509469
White blood cell count decreased 42.80 12.86 83 107201 167026 90354137
Onychomadesis 42.77 12.86 3 107281 45995 90475168
Dyspnoea exertional 42.77 12.86 16 107268 72272 90448891
Gastrointestinal disorder 42.63 12.86 158 107126 256529 90264634
Lactic acidosis 42.35 12.86 5 107279 50458 90470705
Fibula fracture 41.96 12.86 37 107247 4200 90516963
Skin exfoliation 41.94 12.86 14 107270 67899 90453264
Abortion 41.67 12.86 31 107253 2764 90518399
Blindness 41.49 12.86 95 107189 26473 90494690
Papilloma viral infection 41.42 12.86 26 107258 1756 90519407
Post procedural complication 41.38 12.86 78 107206 18964 90502199
Hypoxia 41.23 12.86 17 107267 72382 90448781
Haemoglobin decreased 40.99 12.86 81 107203 161875 90359288
Lupus-like syndrome 40.60 12.86 5 107279 48841 90472322
Joint stiffness 40.30 12.86 21 107263 78021 90443142
Uhthoff's phenomenon 40.18 12.86 7 107277 0 90521163
Autoimmune hepatitis 39.85 12.86 55 107229 10296 90510867
Blood pressure systolic increased 39.76 12.86 10 107274 58335 90462828
Incontinence 39.64 12.86 63 107221 13372 90507791
Headache 39.60 12.86 1317 105967 861429 89659734
Musculoskeletal stiffness 39.19 12.86 199 107085 296333 90224830
Drug reaction with eosinophilia and systemic symptoms 39.15 12.86 3 107281 42755 90478408
Urinary tract infection pseudomonal 38.53 12.86 20 107264 938 90520225
Abdominal distension 37.85 12.86 60 107224 130541 90390622
Liver disorder 37.78 12.86 53 107231 121216 90399947
Tibia fracture 37.50 12.86 41 107243 6046 90515117
Arthropod bite 37.44 12.86 49 107235 8718 90512445
Blindness unilateral 37.41 12.86 46 107238 7690 90513473
Therapy interrupted 37.37 12.86 7 107277 50101 90471062
Lymphocyte count increased 37.34 12.86 34 107250 4025 90517138
Generalised tonic-clonic seizure 37.11 12.86 108 107176 34795 90486368
Foetal malposition 37.07 12.86 10 107274 67 90521096
Gait inability 36.86 12.86 298 106986 146158 90375005
Completed suicide 36.32 12.86 73 107211 144985 90376178
Herpes zoster meningitis 36.29 12.86 11 107273 117 90521046
Cough 36.08 12.86 272 107012 368690 90152473
Low birth weight baby 35.99 12.86 50 107234 9417 90511746
Therapeutic procedure 35.92 12.86 19 107265 927 90520236
Wound infection 35.71 12.86 44 107240 106358 90414805
Latent tuberculosis 35.66 12.86 29 107255 2947 90518216
Constipation 35.47 12.86 191 107093 280204 90240959
Liver function test increased 35.45 12.86 29 107255 84826 90436337
Epilepsy 35.15 12.86 191 107093 82015 90439148
Female genital operation 34.86 12.86 8 107276 24 90521139
Infusion related reaction 34.54 12.86 321 106963 416459 90104704
Appendicitis 34.44 12.86 51 107233 10180 90510983
Retinitis 34.38 12.86 3 107281 38455 90482708
Blindness transient 34.08 12.86 34 107250 4509 90516654
Pain 34.04 12.86 909 106375 995432 89525731
Steroid therapy 33.94 12.86 11 107273 148 90521015
Major depression 33.75 12.86 50 107234 9985 90511178
Colon cancer metastatic 33.70 12.86 21 107263 1400 90519763
Female reproductive tract disorder 33.66 12.86 16 107268 620 90520543
Cerebrovascular accident 33.64 12.86 256 107028 123277 90397886
Musculoskeletal pain 33.54 12.86 98 107186 171153 90350010
Metabolic acidosis 33.48 12.86 12 107272 55664 90465499
Anal incontinence 33.45 12.86 65 107219 16165 90504998
Infection 33.32 12.86 608 106676 361486 90159677
Urostomy 33.21 12.86 7 107277 12 90521151
Herpes simplex encephalitis 33.13 12.86 14 107270 409 90520754
Pyelonephritis 33.04 12.86 76 107208 21240 90499923
Herpes simplex meningitis 32.78 12.86 9 107275 65 90521098
Endometrial cancer 32.73 12.86 30 107254 3582 90517581
Uterine cancer 32.70 12.86 36 107248 5349 90515814
Unevaluable event 32.68 12.86 12 107272 54836 90466327
Adverse reaction 32.62 12.86 93 107191 29619 90491544
Herpes virus infection 32.56 12.86 39 107245 6345 90514818
Arrested labour 32.05 12.86 12 107272 253 90520910
Muscle tightness 31.66 12.86 57 107227 13382 90507781
Accidental exposure to product 31.42 12.86 6 107278 42360 90478803
Depression suicidal 31.16 12.86 23 107261 2026 90519137
Neuralgia 31.15 12.86 95 107189 31405 90489758
Insomnia 31.11 12.86 249 107035 333225 90187938
Rhabdomyolysis 30.90 12.86 11 107273 51245 90469918
Foot deformity 30.87 12.86 16 107268 59635 90461528
Malignant melanoma stage I 30.85 12.86 8 107276 45 90521118
Bile acid malabsorption 30.79 12.86 12 107272 283 90520880
Dysphemia 30.78 12.86 27 107257 3043 90518120
Hypoglycaemia 30.27 12.86 23 107261 69825 90451338
Contusion 30.20 12.86 174 107110 251042 90270121
Fluid retention 30.01 12.86 36 107248 88055 90433108
Neutralising antibodies 30.00 12.86 8 107276 51 90521112
Myelitis transverse 29.97 12.86 20 107264 1500 90519663
Inappropriate schedule of product administration 29.95 12.86 85 107199 149848 90371315
Pruritus allergic 29.74 12.86 21 107263 1727 90519436
Nasal congestion 29.60 12.86 33 107251 83381 90437782
Osteomyelitis 29.45 12.86 86 107198 27760 90493403
Paternal exposure before pregnancy 29.42 12.86 9 107275 99 90521064
Precancerous cells present 29.23 12.86 20 107264 1563 90519600
Infectious mononucleosis 29.21 12.86 22 107262 1999 90519164
Tooth infection 29.18 12.86 70 107214 20100 90501063
Monoparesis 29.15 12.86 22 107262 2005 90519158
Human papilloma virus test positive 29.03 12.86 15 107269 697 90520466
Productive cough 29.01 12.86 29 107255 77034 90444129
Macular degeneration 28.98 12.86 5 107279 37965 90483198
Plasmablastic lymphoma 28.94 12.86 11 107273 242 90520921
Paralysis 28.74 12.86 50 107234 11428 90509735
Oedema peripheral 28.72 12.86 183 107101 257732 90263431
Anembryonic gestation 28.63 12.86 14 107270 578 90520585
Pneumonia 28.44 12.86 971 106313 637088 89884075
Knee operation 28.44 12.86 38 107246 6898 90514265
Mammoplasty 28.41 12.86 15 107269 729 90520434
Visual acuity reduced 28.40 12.86 76 107208 23334 90497829
Micturition urgency 28.21 12.86 49 107235 11184 90509979
Anaemia neonatal 28.01 12.86 12 107272 363 90520800
Lung cancer metastatic 27.99 12.86 25 107259 2886 90518277
Epistaxis 27.73 12.86 36 107248 85089 90436074
Disability 27.73 12.86 7 107277 40738 90480425
Road traffic accident 27.62 12.86 220 107064 107406 90413757
Anaemia 27.41 12.86 276 107008 352526 90168637
Concussion 27.36 12.86 48 107236 11043 90510120
JC polyomavirus test 27.36 12.86 7 107277 37 90521126
Impaired self-care 27.30 12.86 20 107264 1742 90519421
CD4 lymphocytes decreased 27.28 12.86 19 107265 1528 90519635
Ligament sprain 27.13 12.86 56 107228 14543 90506620
Motor dysfunction 27.03 12.86 66 107218 19164 90501999
Catheter placement 26.93 12.86 23 107261 2501 90518662
Tachycardia 26.86 12.86 96 107188 157577 90363586
B-cell lymphoma 26.82 12.86 27 107257 3619 90517544
Status epilepticus 26.76 12.86 65 107219 18809 90502354
Postoperative wound infection 26.73 12.86 53 107231 13373 90507790
Hyperhidrosis 26.69 12.86 78 107206 136227 90384936
Dry eye 26.51 12.86 18 107266 57913 90463250
Obesity 26.49 12.86 53 107231 105454 90415709
Progressive relapsing multiple sclerosis 26.47 12.86 7 107277 43 90521120
Post-traumatic headache 26.40 12.86 6 107278 17 90521146
Animal bite 26.35 12.86 25 107259 3118 90518045
Pruritus 26.26 12.86 467 106817 541058 89980105
Immune system disorder 26.16 12.86 49 107235 11856 90509307
Hepatic cirrhosis 25.95 12.86 22 107262 63231 90457932
Cholelithiasis 25.92 12.86 127 107157 52379 90468784
Hypokalaemia 25.69 12.86 75 107209 131041 90390122
Panic attack 25.59 12.86 79 107205 26286 90494877
International normalised ratio increased 25.53 12.86 12 107272 47304 90473859
Red blood cell nucleated morphology present 25.44 12.86 6 107278 21 90521142
Diabetes mellitus 25.26 12.86 147 107137 64728 90456435
Quadriplegia 25.18 12.86 21 107263 2210 90518953
Demyelination 25.16 12.86 39 107245 8101 90513062
Incorrect drug administration rate 25.16 12.86 31 107253 5192 90515971
Gastric banding 25.15 12.86 8 107276 101 90521062
Hypotension 25.09 12.86 255 107029 325142 90196021
Emotional disorder 24.95 12.86 55 107229 14942 90506221
Magnetic resonance imaging head abnormal 24.67 12.86 22 107262 2534 90518629
Coeliac disease 24.56 12.86 11 107273 44599 90476564
Bladder catheterisation 24.26 12.86 11 107273 382 90520781
Metastatic malignant melanoma 24.19 12.86 18 107266 1606 90519557
Hypocalcaemia 24.04 12.86 10 107274 42358 90478805
Mammogram abnormal 24.01 12.86 14 107270 827 90520336
Deep vein thrombosis 23.90 12.86 188 107096 91432 90429731
Lung neoplasm malignant 23.81 12.86 73 107211 24200 90496963
Melaena 23.64 12.86 6 107278 34791 90486372
Fibroadenoma of breast 23.58 12.86 14 107270 855 90520308
Multiple allergies 23.47 12.86 54 107230 15092 90506071
Sedation 23.37 12.86 14 107270 48157 90473006
Infusion site haematoma 23.29 12.86 10 107274 304 90520859
Injection site haemorrhage 23.29 12.86 3 107281 28315 90492848
Autoimmune haemolytic anaemia 23.26 12.86 31 107253 5614 90515549
Perinatal stroke 23.22 12.86 5 107279 10 90521153
Ascites 22.99 12.86 14 107270 47726 90473437
Musculoskeletal procedural complication 22.96 12.86 4 107280 0 90521163
Adenosquamous cell lung cancer stage IV 22.90 12.86 5 107279 11 90521152
Chills 22.87 12.86 248 107036 131733 90389430
Paraplegia 22.81 12.86 24 107260 3388 90517775
Adenomyosis 22.79 12.86 12 107272 580 90520583
Medical device change 22.76 12.86 10 107274 322 90520841
Tooth abscess 22.72 12.86 56 107228 16357 90504806
Haemorrhagic adrenal infarction 22.67 12.86 6 107278 37 90521126
Walking aid user 22.49 12.86 7 107277 35499 90485664
Accident 22.46 12.86 34 107250 6920 90514243
Cardio-respiratory arrest 22.38 12.86 25 107259 63115 90458048
Clumsiness 22.36 12.86 21 107263 2586 90518577
Hyperemesis gravidarum 22.34 12.86 13 107271 765 90520398
Amnesia 22.21 12.86 211 107073 108294 90412869
Nervous system disorder 22.18 12.86 66 107218 21527 90499636
Cervical spinal stenosis 22.17 12.86 21 107263 2614 90518549
Stevens-Johnson syndrome 22.13 12.86 4 107280 29372 90491791
Infected skin ulcer 22.12 12.86 21 107263 2621 90518542
Urinary retention 22.12 12.86 96 107188 37648 90483515
Gastroenteritis cryptosporidial 22.03 12.86 7 107277 88 90521075
Status migrainosus 21.94 12.86 8 107276 156 90521007
Varicella virus test positive 21.90 12.86 8 107276 157 90521006
Conversion disorder 21.77 12.86 19 107265 2127 90519036
Thermal burn 21.75 12.86 33 107251 6729 90514434
Goitre 21.73 12.86 33 107251 6734 90514429
Tenderness 21.73 12.86 3 107281 26865 90494298
Hypervolaemia 21.59 12.86 6 107278 32751 90488412
Cholestasis 21.53 12.86 8 107276 36291 90484872
Wound sepsis 21.44 12.86 8 107276 167 90520996
Endometrial adenocarcinoma 21.43 12.86 16 107268 1434 90519729
Serotonin syndrome 21.40 12.86 9 107275 37878 90483285
Meningitis 21.31 12.86 37 107247 8444 90512719
Post procedural sepsis 21.27 12.86 10 107274 378 90520785
Foetal heart rate deceleration abnormality 21.24 12.86 12 107272 667 90520496
Benign neoplasm 21.23 12.86 14 107270 1029 90520134
Diplegia 21.19 12.86 16 107268 1459 90519704
Blood urea increased 21.14 12.86 5 107279 30408 90490755
Blood creatine phosphokinase increased 21.03 12.86 7 107277 34016 90487147
Ovarian cystectomy 20.96 12.86 8 107276 178 90520985
Drug tolerance decreased 20.96 12.86 6 107278 32124 90489039
Ligament rupture 20.95 12.86 24 107260 3724 90517439
Onychomycosis 20.92 12.86 9 107275 37367 90483796
Neurogenic bowel 20.88 12.86 8 107276 180 90520983
Quadriparesis 20.85 12.86 20 107264 2529 90518634
H1N1 influenza 20.80 12.86 18 107266 1992 90519171
Procedural complication 20.80 12.86 30 107254 5848 90515315
Ovarian cyst 20.78 12.86 56 107228 17262 90503901
Necrotising retinitis 20.77 12.86 11 107273 538 90520625
Rash erythematous 20.73 12.86 28 107256 65076 90456087
Squamous cell carcinoma of the cervix 20.67 12.86 10 107274 403 90520760
Back pain 20.52 12.86 506 106778 316669 90204494
Brain neoplasm 20.48 12.86 27 107257 4837 90516326
Dysphagia 20.39 12.86 213 107071 112065 90409098
Breast cancer stage I 20.39 12.86 39 107245 9585 90511578
Optic atrophy 20.39 12.86 16 107268 1545 90519618
Device related infection 20.32 12.86 72 107212 25714 90495449
Hip arthroplasty 20.25 12.86 37 107247 76171 90444992
Oral infection 20.24 12.86 28 107256 5252 90515911
Corneal decompensation 20.22 12.86 6 107278 59 90521104
Fear 20.20 12.86 54 107230 16568 90504595
Tubulointerstitial nephritis 20.10 12.86 3 107281 25340 90495823
Appendicectomy 20.06 12.86 23 107261 3573 90517590
Post procedural pneumonia 20.04 12.86 6 107278 61 90521102
Incision site pain 19.91 12.86 15 107269 1363 90519800
Mental status changes 19.91 12.86 105 107179 44574 90476589
Cephalo-pelvic disproportion 19.87 12.86 8 107276 206 90520957
JC virus infection 19.76 12.86 20 107264 2699 90518464
Oral pain 19.73 12.86 7 107277 32676 90488487
Cholecystitis infective 19.70 12.86 17 107267 1875 90519288
Pulmonary embolism 19.60 12.86 239 107045 130581 90390582
Blood pressure diastolic decreased 19.47 12.86 4 107280 26822 90494341
Ventricular tachycardia 19.42 12.86 3 107281 24705 90496458
Gastrointestinal viral infection 19.39 12.86 15 107269 1418 90519745
Bone marrow failure 19.28 12.86 7 107277 32214 90488949
Hypomagnesaemia 19.24 12.86 9 107275 35579 90485584
Cervix carcinoma stage III 19.14 12.86 6 107278 72 90521091
Partial seizures with secondary generalisation 19.07 12.86 10 107274 479 90520684
Product administration error 19.06 12.86 4 107280 26419 90494744
Gallbladder disorder 18.91 12.86 59 107225 19744 90501419
Gastrointestinal haemorrhage 18.89 12.86 50 107234 90198 90430965
Ejection fraction decreased 18.88 12.86 4 107280 26249 90494914
Calculus bladder 18.86 12.86 11 107273 650 90520513
Injection site rash 18.85 12.86 3 107281 24170 90496993
Pulmonary arterial hypertension 18.81 12.86 4 107280 26183 90494980
Colour blindness acquired 18.81 12.86 7 107277 145 90521018
Osteonecrosis 18.76 12.86 71 107213 26170 90494993
Rebound effect 18.63 12.86 37 107247 9347 90511816
Cervicitis human papilloma virus 18.58 12.86 4 107280 8 90521155
Drug level increased 18.45 12.86 5 107279 27757 90493406
Leukaemia 18.43 12.86 26 107258 4966 90516197
Communication disorder 18.41 12.86 21 107263 3245 90517918
Dysplastic naevus 18.40 12.86 8 107276 251 90520912
Product administered to patient of inappropriate age 18.33 12.86 25 107259 4628 90516535
Medical device removal 18.14 12.86 14 107270 1319 90519844
Pertussis 18.04 12.86 12 107272 895 90520268
Overdose 18.01 12.86 111 107173 157598 90363565
Hypercalcaemia 17.99 12.86 9 107275 34231 90486932
Depressed level of consciousness 17.90 12.86 37 107247 72747 90448416
Metabolic surgery 17.85 12.86 15 107269 1596 90519567
Interstitial lung disease 17.82 12.86 40 107244 76365 90444798
Vulvovaginal mycotic infection 17.80 12.86 29 107255 6285 90514878
Eye irritation 17.75 12.86 9 107275 33969 90487194
Invasive breast carcinoma 17.66 12.86 12 107272 927 90520236
Visual field defect 17.66 12.86 31 107253 7135 90514028
Metastatic squamous cell carcinoma 17.61 12.86 8 107276 279 90520884
Eczema 17.59 12.86 22 107262 52848 90468315
Drug resistance 17.58 12.86 7 107277 30442 90490721
Mouth ulceration 17.53 12.86 13 107271 39961 90481202
Tumefactive multiple sclerosis 17.50 12.86 6 107278 97 90521066
Circulatory collapse 17.49 12.86 4 107280 24900 90496263
Haematochezia 17.48 12.86 36 107248 70877 90450286
Flatulence 17.45 12.86 14 107270 41353 90479810
Bladder squamous cell carcinoma stage unspecified 17.22 12.86 3 107281 0 90521163
Gestational oedema 17.22 12.86 3 107281 0 90521163
Colitis ulcerative 17.16 12.86 28 107256 60238 90460925
Foetal distress syndrome 17.11 12.86 15 107269 1690 90519473
Incoherent 17.03 12.86 25 107259 4952 90516211
Gait spastic 17.02 12.86 8 107276 302 90520861
Product dose omission issue 17.01 12.86 459 106825 291228 90229935
Malignant melanoma stage III 16.96 12.86 4 107280 14 90521149
Rhinorrhoea 16.95 12.86 51 107233 88265 90432898
Vulvar dysplasia 16.94 12.86 7 107277 193 90520970
Hypersomnia 16.86 12.86 60 107224 21471 90499692
Disease recurrence 16.83 12.86 12 107272 37641 90483522
Ophthalmoplegia 16.78 12.86 15 107269 1734 90519429
Bladder repair 16.75 12.86 6 107278 111 90521052
Transverse presentation 16.75 12.86 4 107280 15 90521148
Bladder spasm 16.74 12.86 16 107268 2014 90519149
Herpes ophthalmic 16.73 12.86 14 107270 1480 90519683
Myositis 16.70 12.86 4 107280 24124 90497039
Paraesthesia 16.68 12.86 401 106883 249925 90271238
Blepharospasm 16.51 12.86 25 107259 55420 90465743
Breast cyst 16.49 12.86 16 107268 2051 90519112
Facial paralysis 16.45 12.86 48 107236 15486 90505677
Cervical incompetence 16.45 12.86 10 107274 638 90520525
Hepatic cytolysis 16.44 12.86 8 107276 30908 90490255
Malignant glioma 16.35 12.86 4 107280 17 90521146
Pancreatic carcinoma metastatic 16.33 12.86 17 107267 2371 90518792
Urinary tract disorder 16.25 12.86 21 107263 3690 90517473
Migraine 16.21 12.86 316 106968 190076 90331087
Metastases to bone 16.20 12.86 5 107279 25500 90495663
Synovial sarcoma 16.10 12.86 5 107279 58 90521105
Ovarian mass 16.00 12.86 11 107273 866 90520297
Perineal injury 15.96 12.86 6 107278 128 90521035
Amyotrophic lateral sclerosis 15.87 12.86 13 107271 1335 90519828
Plasma cell myeloma 15.79 12.86 15 107269 40813 90480350
Drowning 15.77 12.86 9 107275 510 90520653
Psychotic disorder 15.75 12.86 76 107208 31154 90490009
Smear cervix abnormal 15.71 12.86 19 107265 3123 90518040
Postoperative abscess 15.63 12.86 9 107275 519 90520644
Pre-eclampsia 15.61 12.86 38 107246 11010 90510153
Chronic kidney disease 15.56 12.86 22 107262 50169 90470994
Imminent abortion 15.50 12.86 4 107280 22 90521141
Ovarian neoplasm 15.47 12.86 11 107273 914 90520249
Escherichia sepsis 15.44 12.86 26 107258 5790 90515373
Brain stem syndrome 15.43 12.86 10 107274 714 90520449
Cellulitis staphylococcal 15.28 12.86 11 107273 932 90520231
Respiratory tract infection 15.28 12.86 121 107163 58957 90462206
Hyperglycaemia 15.16 12.86 23 107261 50947 90470216
Urinary cystectomy 15.15 12.86 3 107281 3 90521160
Foetal heart rate abnormal 15.09 12.86 11 107273 951 90520212
Osteoporosis 15.00 12.86 61 107223 96470 90424693
Vibratory sense increased 14.93 12.86 4 107280 26 90521137
Sputum discoloured 14.89 12.86 3 107281 20388 90500775
Monoplegia 14.87 12.86 20 107264 3654 90517509
Cervix carcinoma stage 0 14.86 12.86 9 107275 570 90520593
Premature separation of placenta 14.71 12.86 16 107268 2346 90518817
Astrocytoma malignant 14.68 12.86 4 107280 28 90521135
Injection site mass 14.64 12.86 4 107280 22086 90499077
Vitamin D decreased 14.64 12.86 39 107245 11940 90509223
Leukocytosis 14.62 12.86 74 107210 30916 90490247
Bipolar I disorder 14.56 12.86 15 107269 2067 90519096
Skin cancer 14.53 12.86 42 107242 13477 90507686
Vestibular neuronitis 14.53 12.86 10 107274 789 90520374
Bladder operation 14.48 12.86 11 107273 1012 90520151
Proteus infection 14.46 12.86 13 107271 1513 90519650
Gastrointestinal lymphoma 14.41 12.86 5 107279 84 90521079
Dissociative identity disorder 14.41 12.86 5 107279 84 90521079
Haemoptysis 14.40 12.86 11 107273 33309 90487854
Urinary tract infection staphylococcal 14.36 12.86 8 107276 433 90520730
Spondylitic myelopathy 14.32 12.86 4 107280 31 90521132
Fractured coccyx 14.29 12.86 12 107272 1275 90519888
Intention tremor 14.22 12.86 8 107276 441 90520722
Pelvic fracture 14.21 12.86 45 107239 15174 90505989
Thyroid adenoma 14.21 12.86 6 107278 175 90520988
Lung adenocarcinoma stage IV 14.21 12.86 8 107276 442 90520721
Arthritis 14.21 12.86 128 107156 167187 90353976
Myelofibrosis 14.17 12.86 13 107271 1554 90519609
Renal cell carcinoma 14.13 12.86 20 107264 3831 90517332
Neurological decompensation 14.08 12.86 19 107265 3482 90517681
Face oedema 14.06 12.86 5 107279 23313 90497850
Somnolence 14.06 12.86 169 107115 208915 90312248
Feeling cold 13.96 12.86 67 107217 27398 90493765
Haemorrhage in pregnancy 13.95 12.86 15 107269 2170 90518993
Exostosis 13.94 12.86 26 107258 53108 90468055
Intrathecal pump insertion 13.93 12.86 3 107281 6 90521157
Protein S increased 13.93 12.86 3 107281 6 90521157
Hepatitis E 13.86 12.86 14 107270 1885 90519278
Abdominal adhesions 13.85 12.86 19 107265 3536 90517627
Infertility 13.79 12.86 10 107274 857 90520306
Ligament injury 13.78 12.86 11 107273 1088 90520075
Oral herpes 13.73 12.86 77 107207 33447 90487716
Precancerous skin lesion 13.72 12.86 12 107272 1347 90519816
Hepatic function abnormal 13.66 12.86 21 107263 46267 90474896
Premature rupture of membranes 13.64 12.86 24 107260 5534 90515629
Hypoaesthesia oral 13.55 12.86 45 107239 15555 90505608
Device malfunction 13.53 12.86 4 107280 20973 90500190
Melanocytic naevus 13.52 12.86 23 107261 5163 90516000
Female sterilisation 13.50 12.86 9 107275 674 90520489
Underweight 13.49 12.86 12 107272 1378 90519785
Breast cancer metastatic 13.46 12.86 44 107240 15088 90506075
Uterine cyst 13.41 12.86 8 107276 493 90520670
Breast hyperplasia 13.38 12.86 7 107277 334 90520829
Pineal gland cyst 13.35 12.86 6 107278 204 90520959
Imaging procedure abnormal 13.33 12.86 3 107281 8 90521155
Umbilical cord around neck 13.27 12.86 6 107278 207 90520956
Tonsillitis 13.26 12.86 27 107257 6942 90514221
Hepatocellular injury 13.25 12.86 9 107275 28949 90492214
Myalgia 13.17 12.86 138 107146 174987 90346176
Psychogenic seizure 13.16 12.86 14 107270 2002 90519161
Foetal heart rate decreased 13.14 12.86 6 107278 212 90520951
Colectomy 13.12 12.86 18 107266 3349 90517814
Bronchiectasis 13.11 12.86 5 107279 22325 90498838
Pneumonitis 13.07 12.86 20 107264 44150 90477013
Lhermitte's sign 13.07 12.86 3 107281 9 90521154
Detrusor sphincter dyssynergia 13.07 12.86 3 107281 9 90521154
Premature delivery 13.03 12.86 16 107268 38746 90482417
Upper respiratory tract congestion 12.99 12.86 15 107269 2347 90518816
Erythema 12.97 12.86 192 107092 229054 90292109
Decreased vibratory sense 12.93 12.86 7 107277 358 90520805

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
Multiple sclerosis relapse 4973.70 16.47 1294 30054 12970 42577017
Progressive multifocal leukoencephalopathy 2016.46 16.47 611 30737 10925 42579062
Immune reconstitution inflammatory syndrome 1029.47 16.47 356 30992 9787 42580200
Urinary tract infection 771.07 16.47 614 30734 98670 42491317
General symptom 675.47 16.47 157 31191 914 42589073
Prescribed underdose 463.18 16.47 200 31148 10082 42579905
Opportunistic infection 440.86 16.47 127 31221 1874 42588113
Gait disturbance 359.29 16.47 400 30948 97600 42492387
Malaise 351.09 16.47 588 30760 211568 42378419
Drug specific antibody present 346.65 16.47 125 31223 3881 42586106
Secondary progressive multiple sclerosis 256.79 16.47 60 31288 358 42589629
Fall 256.72 16.47 545 30803 233975 42356012
Balance disorder 255.56 16.47 239 31109 47406 42542581
Magnetic resonance imaging abnormal 251.40 16.47 80 31268 1678 42588309
Memory impairment 244.86 16.47 239 31109 49983 42540004
Cognitive disorder 238.37 16.47 199 31149 33973 42556014
Muscle spasticity 237.92 16.47 111 31237 6711 42583276
Muscular weakness 216.20 16.47 286 31062 83212 42506775
Off label use 210.89 16.47 104 31244 638231 41951756
Mobility decreased 208.57 16.47 187 31161 35119 42554868
JC polyomavirus test positive 203.08 16.47 60 31288 971 42589016
Gait inability 171.81 16.47 139 31209 22694 42567293
Seizure 166.20 16.47 309 31039 120252 42469735
Loss of control of legs 161.08 16.47 48 31300 801 42589186
Drug interaction 160.20 16.47 9 31339 266990 42322997
Central nervous system lesion 154.67 16.47 87 31261 7783 42582204
Multiple sclerosis 146.63 16.47 83 31265 7515 42582472
Herpes zoster 144.39 16.47 160 31188 38717 42551270
Asthenia 137.70 16.47 486 30862 280307 42309680
Neoplasm malignant 137.32 16.47 122 31226 22621 42567366
Hypersensitivity 134.62 16.47 212 31136 72158 42517829
Poor venous access 133.99 16.47 77 31271 7175 42582812
Urosepsis 133.68 16.47 101 31247 14919 42575068
Decubitus ulcer 129.27 16.47 86 31262 10391 42579596
Febrile neutropenia 122.42 16.47 3 31345 185700 42404287
Musculoskeletal disorder 121.35 16.47 70 31278 6568 42583419
Acute kidney injury 114.69 16.47 64 31284 367273 42222714
Cystitis 113.82 16.47 83 31265 11615 42578372
Surgery 111.34 16.47 97 31251 17519 42572468
Road traffic accident 108.51 16.47 99 31249 18994 42570993
Toxicity to various agents 108.42 16.47 19 31329 229117 42360870
Influenza 104.51 16.47 174 31174 62001 42527986
Product use in unapproved indication 102.51 16.47 9 31339 184447 42405540
Neutropenia 102.46 16.47 13 31335 199418 42390569
Hypoaesthesia 98.13 16.47 183 31165 71280 42518707
Neurogenic bladder 95.33 16.47 42 31306 2218 42587769
Drug delivery device placement 92.33 16.47 21 31327 109 42589878
Progressive multiple sclerosis 92.27 16.47 24 31324 235 42589752
Diarrhoea 85.07 16.47 130 31218 460719 42129268
Nasopharyngitis 81.03 16.47 186 31162 83810 42506177
Primary progressive multiple sclerosis 80.93 16.47 16 31332 35 42589952
Death 80.30 16.47 606 30742 470579 42119408
Anaemia 78.84 16.47 55 31293 280223 42309764
Coordination abnormal 78.04 16.47 57 31291 7993 42581994
Condition aggravated 76.25 16.47 49 31299 260705 42329282
Visual impairment 72.88 16.47 121 31227 42992 42546995
Infection 69.08 16.47 210 31138 111858 42478129
Optic neuritis 68.65 16.47 41 31307 4101 42585886
Renal impairment 68.28 16.47 3 31345 110225 42479762
Blood creatinine increased 68.12 16.47 3 31345 110000 42479987
Lower limb fracture 66.70 16.47 43 31305 4924 42585063
Decreased appetite 65.60 16.47 30 31318 193107 42396880
Depression 63.39 16.47 203 31145 111160 42478827
Dyspnoea 60.60 16.47 149 31199 442472 42147515
Cellulitis 58.95 16.47 136 31212 61449 42528538
Pancytopenia 57.32 16.47 9 31339 117734 42472253
Thrombocytopenia 56.62 16.47 35 31313 190244 42399743
Hyponatraemia 56.19 16.47 5 31343 101457 42488530
Disease progression 52.49 16.47 20 31328 143636 42446351
Neuromyelitis optica spectrum disorder 50.18 16.47 15 31333 253 42589734
Somnolence 49.34 16.47 21 31327 141084 42448903
Urinary tract infection pseudomonal 47.62 16.47 22 31326 1299 42588688
Neutralising antibodies positive 46.27 16.47 12 31336 116 42589871
Hypotension 46.12 16.47 74 31274 257557 42332430
Haemoglobin decreased 45.86 16.47 20 31328 132451 42457536
Hip fracture 45.81 16.47 53 31295 13419 42576568
Agraphia 45.74 16.47 9 31339 19 42589968
Nephrolithiasis 45.22 16.47 90 31258 36740 42553247
Intervertebral disc protrusion 43.56 16.47 47 31301 11025 42578962
Herpes zoster necrotising retinopathy 43.51 16.47 7 31341 0 42589987
Influenza like illness 42.99 16.47 81 31267 31759 42558228
Muscle spasms 42.85 16.47 150 31198 85894 42504093
Nausea 42.33 16.47 150 31198 396649 42193338
Hyperkalaemia 41.87 16.47 5 31343 80453 42509534
Trigeminal neuralgia 41.09 16.47 21 31327 1548 42588439
JC virus granule cell neuronopathy 41.02 16.47 7 31341 3 42589984
Platelet count decreased 40.50 16.47 26 31322 138555 42451432
Infusion site extravasation 40.43 16.47 33 31315 5448 42584539
Rhabdomyolysis 40.23 16.47 5 31343 78014 42511973
Drug abuse 39.25 16.47 14 31334 104757 42485230
Cardiac failure 38.81 16.47 15 31333 106841 42483146
Escherichia urinary tract infection 38.06 16.47 29 31319 4334 42585653
Marburg's variant multiple sclerosis 37.30 16.47 6 31342 0 42589987
Abdominal pain 36.68 16.47 52 31296 190419 42399568
Mental disorder 36.53 16.47 55 31293 17974 42572013
Foetal exposure timing unspecified 36.49 16.47 12 31336 280 42589707
Paraparesis 35.63 16.47 21 31327 2050 42587937
Malignant melanoma 35.40 16.47 39 31309 9361 42580626
Weight increased 34.76 16.47 18 31330 107965 42482022
White blood cell count decreased 34.66 16.47 19 31329 110377 42479610
Gastrointestinal haemorrhage 33.43 16.47 15 31333 97711 42492276
Neutrophil count decreased 32.85 16.47 4 31344 63411 42526576
Motor dysfunction 32.78 16.47 35 31313 8111 42581876
Epistaxis 32.75 16.47 5 31343 66821 42523166
Staphylococcal infection 32.62 16.47 80 31268 37563 42552424
Drug ineffective 32.50 16.47 646 30702 629551 41960436
Tumefactive multiple sclerosis 32.20 16.47 8 31340 64 42589923
Pneumonia aspiration 31.90 16.47 95 31253 49983 42540004
Pleural effusion 31.57 16.47 16 31332 97150 42492837
Chronic lymphocytic leukaemia 31.33 16.47 27 31321 4802 42585185
Glioblastoma 31.31 16.47 17 31331 1418 42588569
Neuropathy peripheral 31.30 16.47 18 31330 101835 42488152
Nutritional supplementation 31.08 16.47 5 31343 0 42589987
Epilepsy 30.98 16.47 63 31285 26108 42563879
Multiple organ dysfunction syndrome 30.03 16.47 17 31331 97018 42492969
Drug hypersensitivity 29.92 16.47 18 31330 99371 42490616
Bipolar disorder 29.74 16.47 24 31324 3898 42586089
Hemiparesis 29.65 16.47 49 31299 17327 42572660
Intentional product misuse 29.51 16.47 5 31343 61895 42528092
Product use issue 29.18 16.47 10 31338 76741 42513246
Prostate cancer 28.73 16.47 85 31263 44558 42545429
Speech disorder 28.61 16.47 65 31283 29056 42560931
Infected skin ulcer 28.57 16.47 18 31330 1980 42588007
Aphasia 28.54 16.47 58 31290 24025 42565962
Ascites 28.33 16.47 4 31344 56674 42533313
Peroneal nerve palsy 27.77 16.47 22 31326 3480 42586507
Testis cancer 27.64 16.47 16 31332 1510 42588477
Metabolic acidosis 27.53 16.47 3 31345 51855 42538132
Amnesia 27.41 16.47 63 31285 28374 42561613
Adverse reaction 27.28 16.47 23 31325 3970 42586017
Foetal exposure during pregnancy 26.65 16.47 86 31262 47225 42542762
Urinary incontinence 26.65 16.47 53 31295 21615 42568372
Ophthalmic herpes zoster 26.61 16.47 14 31334 1096 42588891
Tremor 26.53 16.47 141 31207 96788 42493199
Renal failure 25.95 16.47 41 31307 143685 42446302
CD8 lymphocytes decreased 25.85 16.47 7 31341 81 42589906
Meningitis herpes 25.59 16.47 5 31343 10 42589977
HIV test positive 25.54 16.47 8 31340 159 42589828
Small for dates baby 25.51 16.47 25 31323 5238 42584749
Antibody test positive 25.45 16.47 12 31336 742 42589245
Appendicitis perforated 25.28 16.47 17 31331 2089 42587898
Decreased immune responsiveness 25.21 16.47 17 31331 2098 42587889
Haematochezia 25.19 16.47 6 31342 58430 42531557
Dry skin 25.15 16.47 3 31345 48335 42541652
Injection site pain 24.78 16.47 6 31342 57792 42532195
Hemianaesthesia 24.69 16.47 7 31341 97 42589890
Headache 24.31 16.47 276 31072 239093 42350894
Therapeutic product effect incomplete 24.08 16.47 11 31337 70928 42519059
Sinusitis 24.01 16.47 83 31265 47209 42542778
Stem cell transplant 23.84 16.47 18 31330 2654 42587333
Vision blurred 23.66 16.47 90 31258 53609 42536378
Urticaria 23.28 16.47 112 31236 73924 42516063
Lactic acidosis 23.08 16.47 3 31345 45258 42544729
C-reactive protein increased 22.94 16.47 9 31339 63551 42526436
Intentional overdose 22.74 16.47 5 31343 51451 42538536
Mental impairment 22.74 16.47 36 31312 12281 42577706
Relapsing-remitting multiple sclerosis 22.72 16.47 14 31334 1481 42588506
International normalised ratio increased 22.72 16.47 4 31344 48164 42541823
Upper respiratory tract infection 22.27 16.47 75 31273 42098 42547889
Chronic kidney disease 22.11 16.47 4 31344 47237 42542750
Hypoxia 21.91 16.47 12 31336 69774 42520213
Dysstasia 21.76 16.47 38 31310 14048 42575939
Osteomyelitis 21.72 16.47 44 31304 18179 42571808
Gallbladder operation 21.70 16.47 10 31338 587 42589400
Uhthoff's phenomenon 21.20 16.47 4 31344 6 42589981
Central nervous system lymphoma 21.13 16.47 13 31335 1372 42588615
Intervertebral disc operation 20.84 16.47 8 31340 296 42589691
Arthropod bite 20.67 16.47 18 31330 3246 42586741
Leukopenia 20.52 16.47 15 31333 74731 42515256
Basal cell carcinoma 20.42 16.47 49 31299 22684 42567303
Kidney infection 20.33 16.47 25 31323 6745 42583242
Dysgraphia 20.30 16.47 16 31332 2512 42587475
Plasma cell myeloma 20.28 16.47 5 31343 47573 42542414
Abdominal distension 20.21 16.47 14 31334 71721 42518266
Stomatitis 20.12 16.47 6 31342 50323 42539664
Tachycardia 20.04 16.47 27 31321 101060 42488927
Blindness 19.78 16.47 42 31306 17936 42572051
Constipation 19.56 16.47 58 31290 162233 42427754
CD4 lymphocytes decreased 19.52 16.47 14 31334 1907 42588080
Demyelination 19.46 16.47 18 31330 3511 42586476
Ataxia 19.30 16.47 39 31309 16086 42573901
Hypoglycaemia 19.22 16.47 10 31338 59844 42530143
Thrombocytopenia neonatal 19.20 16.47 9 31339 549 42589438
Peripheral swelling 19.04 16.47 23 31325 90247 42499740
Bladder catheterisation 19.04 16.47 10 31338 780 42589207
Herpes simplex encephalitis 19.03 16.47 8 31340 376 42589611
Cardiac failure congestive 18.93 16.47 21 31327 85581 42504406
Agitation 18.86 16.47 12 31336 64302 42525685
Bladder disorder 18.74 16.47 18 31330 3681 42586306
Wernicke-Korsakoff syndrome 18.65 16.47 3 31345 0 42589987
Laryngeal cancer stage 0 18.65 16.47 3 31345 0 42589987
JC polyomavirus test 18.65 16.47 3 31345 0 42589987
Drug rehabilitation 18.65 16.47 3 31345 0 42589987
Bronchitis 18.29 16.47 76 31272 47125 42542862
Back disorder 18.27 16.47 25 31323 7489 42582498
Temperature intolerance 18.26 16.47 20 31328 4768 42585219
Head injury 18.10 16.47 44 31304 20538 42569449
Urinary tract disorder 18.05 16.47 15 31333 2539 42587448
Focal dyscognitive seizures 17.99 16.47 12 31336 1455 42588532
Tonsil cancer 17.97 16.47 11 31337 1150 42588837
Rectal haemorrhage 17.94 16.47 7 31341 49599 42540388
Ill-defined disorder 17.84 16.47 38 31310 16258 42573729
B-cell lymphoma 17.84 16.47 20 31328 4893 42585094
Bradycardia 17.80 16.47 22 31326 85462 42504525
Lyme disease 17.68 16.47 11 31337 1184 42588803
Oedema peripheral 17.60 16.47 47 31301 136029 42453958
Haemoptysis 17.57 16.47 6 31342 46161 42543826
Congenital central nervous system anomaly 17.21 16.47 9 31339 696 42589291
Overdose 17.18 16.47 32 31316 105232 42484755
Cardio-respiratory arrest 17.12 16.47 11 31337 58625 42531362
Brain malformation 16.98 16.47 6 31342 175 42589812
Joint swelling 16.98 16.47 15 31333 68007 42521980
Paraesthesia 16.88 16.47 102 31246 73357 42516630
Concussion 16.84 16.47 15 31333 2787 42587200
Therapeutic product effect decreased 16.74 16.47 65 31283 39085 42550902
Cardiogenic shock 16.72 16.47 3 31345 35637 42554350
Malignant palate neoplasm 16.57 16.47 3 31345 3 42589984
Papillary thyroid cancer 16.54 16.47 9 31339 754 42589233
Hypokalaemia 16.52 16.47 17 31331 71704 42518283
Skin exfoliation 16.52 16.47 5 31343 41548 42548439
Loss of personal independence in daily activities 16.48 16.47 8 31340 49808 42540179

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
Multiple sclerosis relapse 14401.24 13.51 4086 96511 46154 110442548
Progressive multifocal leukoencephalopathy 5578.74 13.51 1678 98919 23278 110465424
Immune reconstitution inflammatory syndrome 3542.25 13.51 1072 99525 15154 110473548
Urinary tract infection 2233.67 13.51 2055 98542 324227 110164475
Abortion spontaneous 1263.59 13.51 619 99978 33663 110455039
General symptom 1078.19 13.51 376 100221 8470 110480232
Drug specific antibody present 1029.91 13.51 359 100238 8075 110480627
Prescribed underdose 898.57 13.51 621 99976 64553 110424149
Fall 852.70 13.51 1765 98832 601717 109886985
Malaise 773.62 13.51 1810 98787 670009 109818693
Balance disorder 685.79 13.51 677 99920 115883 110372819
Off label use 645.47 13.51 281 100316 1499904 108988798
Seizure 636.93 13.51 890 99707 220295 110268407
Poor venous access 622.67 13.51 345 100252 24177 110464525
Gait disturbance 603.88 13.51 981 99616 277227 110211475
Magnetic resonance imaging abnormal 524.57 13.51 179 100418 3766 110484936
Central nervous system lesion 511.34 13.51 260 100337 15293 110473409
Secondary progressive multiple sclerosis 471.62 13.51 133 100464 1436 110487266
Herpes zoster 469.40 13.51 535 100062 107844 110380858
Loss of control of legs 431.35 13.51 133 100464 1999 110486703
Breast cancer 427.51 13.51 322 100275 38220 110450482
Caesarean section 405.41 13.51 214 100383 13603 110475099
Maternal exposure during pregnancy 404.53 13.51 784 99813 254099 110234603
Cognitive disorder 352.07 13.51 416 100181 87095 110401607
Invasive ductal breast carcinoma 350.75 13.51 154 100443 6492 110482210
Muscle spasticity 333.18 13.51 270 100327 35645 110453057
JC polyomavirus test positive 329.77 13.51 111 100486 2236 110486466
Optic neuritis 319.55 13.51 170 100427 10977 110477725
Drug interaction 318.59 13.51 40 100557 500143 109988559
Decubitus ulcer 314.68 13.51 200 100397 18036 110470666
Toxicity to various agents 297.53 13.51 42 100555 480513 110008189
Product use in unapproved indication 296.84 13.51 31 100566 447346 110041356
Muscular weakness 293.84 13.51 678 99919 247790 110240912
Memory impairment 277.81 13.51 577 100020 196367 110292335
Condition aggravated 276.69 13.51 163 100434 734673 109754029
Drug delivery device placement 274.28 13.51 58 100539 150 110488552
Influenza 265.43 13.51 518 100079 168583 110320119
Cystitis 255.83 13.51 308 100289 65728 110422974
Febrile neutropenia 255.52 13.51 7 100590 316760 110171942
Musculoskeletal disorder 248.30 13.51 188 100409 22476 110466226
Urosepsis 241.92 13.51 210 100387 30465 110458237
Hypersensitivity 233.10 13.51 852 99745 403146 110085556
Multiple sclerosis 231.62 13.51 190 100407 25508 110463194
Diarrhoea 225.65 13.51 435 100162 1139070 109349632
Acute kidney injury 225.24 13.51 151 100446 635279 109853423
Trigeminal neuralgia 214.09 13.51 96 100501 4256 110484446
Asthenia 211.12 13.51 1205 99392 687794 109800908
Joint swelling 209.14 13.51 71 100526 442774 110045928
Neutropenia 207.14 13.51 44 100553 374576 110114126
Neutralising antibodies positive 203.00 13.51 51 100546 337 110488365
Neurogenic bladder 202.96 13.51 97 100500 4982 110483720
Product use issue 198.15 13.51 25 100572 311670 110177032
Surgery 197.86 13.51 215 100382 41068 110447634
Opportunistic infection 196.41 13.51 85 100512 3458 110485244
Contraindicated product administered 188.07 13.51 9 100588 248258 110240444
Nasopharyngitis 184.68 13.51 779 99818 393582 110095120
Malignant melanoma 182.57 13.51 139 100458 16752 110471950
Glossodynia 182.45 13.51 4 100593 222000 110266702
Pemphigus 179.84 13.51 3 100594 214567 110274135
Hysterectomy 178.56 13.51 104 100493 8010 110480692
Rheumatoid arthritis 176.64 13.51 30 100567 299583 110189119
Drug hypersensitivity 176.02 13.51 97 100500 453993 110034709
Hip fracture 175.37 13.51 187 100410 34964 110453738
Decreased appetite 169.95 13.51 112 100485 475734 110012968
Peripheral swelling 164.44 13.51 81 100516 403953 110084749
Progressive multiple sclerosis 164.07 13.51 57 100540 1267 110487435
Ankle fracture 163.01 13.51 139 100458 19680 110469022
Drug intolerance 161.69 13.51 84 100513 406428 110082274
Visual impairment 157.83 13.51 366 100231 134062 110354640
Stomatitis 155.08 13.51 29 100568 270213 110218489
Neuromyelitis optica spectrum disorder 152.85 13.51 56 100541 1459 110487243
Hemiparesis 147.96 13.51 191 100406 43712 110444990
Intervertebral disc protrusion 146.45 13.51 152 100445 27546 110461156
Hypoaesthesia 145.69 13.51 619 99978 313604 110175098
Helicobacter infection 139.67 13.51 6 100591 181871 110306831
Weight increased 137.74 13.51 108 100489 419536 110069166
Peroneal nerve palsy 137.16 13.51 85 100512 7329 110481373
Cervical dysplasia 136.56 13.51 61 100536 2679 110486023
Systemic lupus erythematosus 136.25 13.51 32 100565 254306 110234396
Therapeutic product effect incomplete 135.05 13.51 21 100576 223784 110264918
Bronchitis 131.99 13.51 377 100220 156655 110332047
C-reactive protein increased 130.24 13.51 21 100576 217898 110270804
Pericarditis 128.99 13.51 22 100575 219092 110269610
Intraductal proliferative breast lesion 126.90 13.51 59 100538 2846 110485856
Nephrolithiasis 124.06 13.51 219 100378 65993 110422709
Thrombocytopenia 121.98 13.51 84 100513 348801 110139901
Decreased immune responsiveness 121.71 13.51 87 100510 9519 110479183
Stress 119.46 13.51 283 100314 105065 110383637
Abdominal discomfort 118.69 13.51 110 100487 393748 110094954
Uterine leiomyoma 116.11 13.51 78 100519 7722 110480980
Pancytopenia 115.02 13.51 25 100572 209588 110279114
Intentional product use issue 114.78 13.51 41 100556 247865 110240837
Injection site pain 113.69 13.51 14 100583 177908 110310794
Wheezing 113.51 13.51 45 100552 255185 110233517
Vein disorder 111.24 13.51 70 100527 6200 110482502
Folliculitis 110.10 13.51 12 100585 167641 110321061
Treatment failure 107.67 13.51 59 100538 277175 110211527
Renal impairment 106.44 13.51 21 100576 188424 110300278
Depression 106.19 13.51 569 100028 316766 110171936
Hyponatraemia 106.00 13.51 33 100564 217620 110271082
Hyperkalaemia 105.88 13.51 4 100593 135792 110352910
Dyspnoea 105.11 13.51 585 100012 1106287 109382415
Lower respiratory tract infection 104.65 13.51 45 100552 243061 110245641
Mental impairment 103.43 13.51 115 100482 22524 110466178
Cellulitis 103.42 13.51 300 100297 125716 110362986
Escherichia urinary tract infection 102.64 13.51 98 100499 16064 110472638
Disease progression 102.17 13.51 47 100550 243987 110244715
Herpes zoster necrotising retinopathy 102.06 13.51 17 100580 0 110488702
Blood creatinine increased 102.01 13.51 21 100576 182868 110305834
Aphasia 101.44 13.51 188 100409 58809 110429893
Staphylococcal infection 100.93 13.51 207 100390 69737 110418965
Alopecia 100.60 13.51 110 100487 364643 110124059
Urinary incontinence 99.27 13.51 167 100430 48420 110440282
Speech disorder 96.97 13.51 189 100408 61380 110427322
Prolonged labour 96.97 13.51 30 100567 456 110488246
Arthralgia 96.44 13.51 374 100223 779258 109709444
Blister 96.43 13.51 43 100554 227333 110261369
Breech presentation 95.91 13.51 33 100564 712 110487990
Coordination abnormal 94.95 13.51 116 100481 25112 110463590
Fibromyalgia 94.54 13.51 20 100577 170889 110317813
JC virus granule cell neuronopathy 93.88 13.51 23 100574 135 110488567
Drug abuse 93.67 13.51 23 100574 177388 110311314
Head injury 93.46 13.51 152 100445 42865 110445837
Hospitalisation 91.55 13.51 11 100586 142482 110346220
Swelling 91.25 13.51 111 100486 350930 110137772
Gait inability 90.90 13.51 302 100295 136074 110352628
Kidney infection 90.40 13.51 114 100483 25485 110463217
Death 89.84 13.51 1001 99596 697868 109790834
Dry mouth 89.31 13.51 35 100562 199913 110288789
Vision blurred 88.94 13.51 289 100308 128733 110359969
Infusion site extravasation 88.41 13.51 78 100519 11556 110477146
Abdominal pain 87.70 13.51 212 100385 512777 109975925
Relapsing-remitting multiple sclerosis 86.97 13.51 41 100556 2041 110486661
Arthropathy 86.94 13.51 80 100517 287442 110201260
Liver injury 86.56 13.51 16 100581 150397 110338305
Loss of personal independence in daily activities 86.24 13.51 16 100581 150004 110338698
Intentional product misuse 86.03 13.51 10 100587 132894 110355808
Tremor 84.98 13.51 387 100210 201845 110286857
Dyspepsia 84.35 13.51 34 100563 190931 110297771
Breast cancer female 83.77 13.51 78 100519 12390 110476312
Upper respiratory tract infection 82.40 13.51 285 100312 131043 110357659
Irritable bowel syndrome 81.57 13.51 24 100573 164191 110324511
Inflammation 81.22 13.51 37 100560 193201 110295501
Platelet count decreased 81.15 13.51 55 100542 230388 110258314
Diplopia 80.33 13.51 140 100457 41754 110446948
Therapy non-responder 79.97 13.51 22 100575 157285 110331417
Sleep disorder 78.98 13.51 41 100556 198603 110290099
Cardiac failure 78.74 13.51 36 100561 187590 110301112
Gallbladder operation 78.63 13.51 40 100557 2353 110486349
Focal dyscognitive seizures 78.57 13.51 47 100550 3802 110484900
Headache 78.47 13.51 1181 99416 881196 109607506
Lip dry 77.84 13.51 3 100594 100080 110388622
Type 2 diabetes mellitus 77.56 13.51 32 100565 177200 110311502
Mobility decreased 77.54 13.51 423 100174 236999 110251703
Bladder disorder 77.39 13.51 71 100526 11066 110477636
Cervix carcinoma 76.96 13.51 40 100557 2461 110486241
Blood cholesterol increased 76.70 13.51 36 100561 184749 110303953
Electrocardiogram QT prolonged 76.33 13.51 6 100591 108954 110379748
Road traffic accident 76.23 13.51 243 100354 107155 110381547
Urinary tract infection pseudomonal 75.52 13.51 38 100559 2184 110486518
Anaphylactic shock 74.89 13.51 153 100444 51393 110437309
Papillary thyroid cancer 74.21 13.51 41 100556 2853 110485849
Anaemia 73.79 13.51 253 100344 546833 109941869
Central venous catheterisation 73.50 13.51 45 100552 3797 110484905
Post lumbar puncture syndrome 73.10 13.51 30 100567 1067 110487635
Appendicitis perforated 73.01 13.51 44 100553 3608 110485094
Mental disorder 72.26 13.51 128 100469 38663 110450039
Upper limb fracture 72.14 13.51 92 100505 20796 110467906
Multiple organ dysfunction syndrome 72.09 13.51 24 100573 151686 110337016
Influenza like illness 71.11 13.51 209 100388 88203 110400499
Gastric bypass 70.97 13.51 32 100565 1437 110487265
Chronic lymphocytic leukaemia 70.94 13.51 52 100545 5916 110482786
Intentional overdose 70.29 13.51 17 100580 132484 110356218
Meningitis herpes 70.28 13.51 21 100576 282 110488420
Gastroenteritis viral 70.10 13.51 112 100485 31114 110457588
Joint range of motion decreased 70.01 13.51 13 100584 121819 110366883
Flushing 69.85 13.51 232 100365 104504 110384198
Fatigue 69.81 13.51 1519 99078 1214439 109274263
Cholecystectomy 69.51 13.51 66 100531 10743 110477959
Oedema 68.88 13.51 54 100543 209922 110278780
Exposure during pregnancy 67.38 13.51 34 100563 167390 110321312
Neutrophil count decreased 67.20 13.51 14 100583 120927 110367775
Rhabdomyolysis 66.77 13.51 14 100583 120387 110368315
Haemoglobin decreased 66.37 13.51 77 100520 248650 110240052
Ectopic pregnancy 65.74 13.51 35 100562 2262 110486440
Bipolar disorder 65.69 13.51 59 100538 8948 110479754
Central nervous system lymphoma 64.30 13.51 38 100559 3006 110485696
Incorrect dose administered 64.17 13.51 9 100588 103632 110385070
Muscle spasms 63.47 13.51 452 100145 277705 110210997
Pharyngitis streptococcal 63.35 13.51 69 100528 13208 110475494
Pregnancy 63.17 13.51 142 100455 50925 110437777
Partial seizures 63.10 13.51 64 100533 11285 110477417
Thyroid cancer 62.49 13.51 49 100548 6165 110482537
Foot fracture 62.03 13.51 95 100502 25451 110463251
Drug ineffective for unapproved indication 61.22 13.51 10 100587 102828 110385874
Medication error 61.07 13.51 11 100586 105355 110383347
Breast cancer in situ 60.70 13.51 27 100570 1174 110487528
Uhthoff's phenomenon 60.03 13.51 10 100587 0 110488702
Primary progressive multiple sclerosis 59.46 13.51 15 100582 101 110488601
Bursitis 59.24 13.51 22 100575 129896 110358806
Drug reaction with eosinophilia and systemic symptoms 59.00 13.51 4 100593 82091 110406611
Sensory disturbance 58.99 13.51 76 100521 17353 110471349
Neuropathy peripheral 58.93 13.51 46 100551 179231 110309471
Night sweats 58.93 13.51 24 100573 133959 110354743
Injection site erythema 58.73 13.51 8 100589 94168 110394534
Adenocarcinoma of colon 58.52 13.51 47 100550 6121 110482581
Hypercholesterolaemia 58.38 13.51 7 100590 90830 110397872
Prescribed overdose 58.18 13.51 6 100591 87575 110401127
Lactic acidosis 57.60 13.51 8 100589 92803 110395899
Lymphocytosis 57.31 13.51 44 100553 5367 110483335
Leukopenia 57.25 13.51 32 100565 148759 110339943
Lung adenocarcinoma 57.15 13.51 56 100541 9475 110479227
White blood cell count decreased 57.01 13.51 75 100522 229315 110259387
Rectal haemorrhage 56.85 13.51 19 100578 119814 110368888
Pleural effusion 56.66 13.51 47 100550 177662 110311040
Pulmonary fibrosis 56.31 13.51 12 100585 102030 110386672
Dysgraphia 55.93 13.51 41 100556 4664 110484038
Epilepsy 55.65 13.51 209 100388 100000 110388702
Meningioma 55.52 13.51 44 100553 5621 110483081
Wrong technique in product usage process 55.48 13.51 7 100590 87341 110401361
White blood cell count increased 55.47 13.51 204 100393 96638 110392064
Rash maculo-papular 55.20 13.51 3 100594 74219 110414483
General physical health deterioration 55.09 13.51 200 100397 425095 110063607
Nausea 54.94 13.51 793 99804 1234897 109253805
Grip strength decreased 54.55 13.51 5 100592 80169 110408533
Abortion missed 54.34 13.51 27 100570 1510 110487192
Endometriosis 54.33 13.51 39 100558 4295 110484407
Hypertension 54.20 13.51 259 100338 509825 109978877
Ovarian cancer 53.83 13.51 39 100558 4357 110484345
Abdominal distension 53.77 13.51 48 100549 175055 110313647
Pneumonia aspiration 53.32 13.51 179 100418 81054 110407648
Ascites 53.12 13.51 10 100587 92798 110395904
Ophthalmic herpes zoster 53.06 13.51 35 100562 3360 110485342
Wound 52.97 13.51 82 100515 234355 110254347
Invasive lobular breast carcinoma 52.84 13.51 22 100575 812 110487890
Basal cell carcinoma 52.81 13.51 123 100474 45147 110443555
Hypoxia 52.57 13.51 26 100571 129489 110359213
Rash 52.36 13.51 486 100111 820478 109668224
Inappropriate schedule of product administration 52.24 13.51 65 100532 203572 110285130
Dyspnoea exertional 52.06 13.51 15 100582 104045 110384657
Hypotension 51.65 13.51 273 100324 523576 109965126
Dysstasia 51.62 13.51 101 100496 32885 110455817
Viral infection 51.00 13.51 134 100463 53005 110435697
Metabolic acidosis 50.60 13.51 14 100583 99730 110388972
Peripheral venous disease 50.48 13.51 8 100589 84109 110404593
Injury 50.46 13.51 52 100545 177213 110311489
Red blood cell sedimentation rate increased 50.40 13.51 6 100591 78296 110410406
Paraparesis 50.28 13.51 38 100559 4528 110484174
Epistaxis 50.22 13.51 28 100569 130344 110358358
Injection site reaction 50.13 13.51 10 100587 89060 110399642
Gastrointestinal haemorrhage 50.07 13.51 46 100551 165472 110323230
Therapeutic response decreased 49.98 13.51 13 100584 96486 110392216
Psoriasis 49.83 13.51 33 100564 139960 110348742
Foetal malposition 49.75 13.51 10 100587 18 110488684
Tibia fracture 49.74 13.51 44 100553 6541 110482161
Generalised tonic-clonic seizure 49.57 13.51 135 100462 54545 110434157
Ataxia 49.33 13.51 94 100503 30014 110458688
Asthma 48.86 13.51 96 100501 250195 110238507
Oxygen saturation decreased 48.24 13.51 43 100554 156939 110331763
Lung disorder 47.74 13.51 56 100541 179991 110308711
Discomfort 47.65 13.51 76 100521 214631 110274071
Temperature intolerance 47.48 13.51 61 100536 13889 110474813
Clostridial infection 47.38 13.51 42 100555 6260 110482442
Pyelonephritis 46.62 13.51 83 100514 25167 110463535
B-cell lymphoma 46.61 13.51 44 100553 7110 110481592
Incorrect route of product administration 46.39 13.51 3 100594 64058 110424644
Dry skin 46.19 13.51 20 100577 107633 110381069
Feeling abnormal 46.16 13.51 302 100295 180409 110308293
Herpes simplex encephalitis 45.95 13.51 20 100577 825 110487877
Delirium 45.20 13.51 34 100563 134991 110353711
Skin exfoliation 45.03 13.51 12 100585 87639 110401063
Concussion 44.96 13.51 54 100543 11484 110477218
Melaena 44.93 13.51 5 100592 68752 110419950
Injection site swelling 44.43 13.51 3 100594 61787 110426915
Vomiting 44.14 13.51 574 100023 910101 109578601
Fibula fracture 43.54 13.51 35 100562 4563 110484139
Gastrooesophageal reflux disease 43.54 13.51 60 100537 179916 110308786
Post procedural infection 43.30 13.51 58 100539 13751 110474951
Somnolence 43.21 13.51 133 100464 297316 110191386
Interstitial lung disease 43.01 13.51 38 100559 139296 110349406
Frequent bowel movements 42.36 13.51 7 100590 71383 110417319
Marburg's variant multiple sclerosis 42.02 13.51 7 100590 0 110488702
Blood pressure systolic increased 41.44 13.51 12 100585 82979 110405723
Antibody test positive 41.24 13.51 29 100568 3091 110485611
International normalised ratio increased 40.74 13.51 14 100583 86758 110401944
Infection 40.29 13.51 505 100092 361695 110127007
Deep vein thrombosis postoperative 39.54 13.51 4 100593 59287 110429415
JC polyomavirus test 39.38 13.51 9 100588 37 110488665
Sinusitis 39.38 13.51 428 100169 296260 110192442
Hypoglycaemia 39.16 13.51 29 100568 116075 110372627
Vertigo 38.53 13.51 169 100428 86701 110402001
Abortion 38.52 13.51 22 100575 1632 110487070
Breast cancer stage III 38.49 13.51 12 100585 79105 110409597
Tachycardia 38.40 13.51 94 100503 226551 110262151
Atrial fibrillation 38.32 13.51 96 100501 229546 110259156
Myelitis 38.20 13.51 28 100569 3185 110485517
Meningitis viral 38.15 13.51 25 100572 2374 110486328
Urticaria 37.82 13.51 450 100147 318407 110170295
Incontinence 37.79 13.51 60 100537 16575 110472127
Autoimmune disorder 37.59 13.51 7 100590 65476 110423226
Relapsing multiple sclerosis 37.38 13.51 12 100585 207 110488495
Impaired healing 37.06 13.51 77 100520 196640 110292062
Glioblastoma 36.76 13.51 23 100574 2017 110486685
Appendicectomy 36.73 13.51 28 100569 3379 110485323
Tumefactive multiple sclerosis 36.26 13.51 11 100586 156 110488546
Haemoptysis 36.22 13.51 10 100587 71344 110417358
Agraphia 36.02 13.51 9 100588 58 110488644
Productive cough 35.49 13.51 31 100566 114274 110374428
Abdominal pain upper 35.47 13.51 180 100417 348931 110139771
Pruritus allergic 35.47 13.51 21 100576 1667 110487035
Major depression 35.45 13.51 46 100551 10575 110478127
Cough 35.41 13.51 260 100337 461381 110027321
Band sensation 35.36 13.51 18 100579 1060 110487642
Vaginal infection 35.35 13.51 37 100560 6767 110481935
Tubulointerstitial nephritis 35.34 13.51 4 100593 54280 110434422
Hemianaesthesia 35.24 13.51 14 100583 457 110488245
Haematochezia 35.06 13.51 32 100565 115492 110373210
Female genital operation 34.69 13.51 7 100590 13 110488689
Agranulocytosis 34.61 13.51 7 100590 61753 110426949
Urostomy 34.35 13.51 7 100590 14 110488688
Arthropod bite 34.03 13.51 43 100554 9628 110479074
Osteoarthritis 33.97 13.51 72 100525 182551 110306151
Immune system disorder 33.90 13.51 51 100546 13450 110475252
Osteomyelitis 33.81 13.51 91 100506 36509 110452193
Weight decreased 33.37 13.51 269 100328 467788 110020914
Meningoencephalitis herpetic 33.33 13.51 23 100574 2379 110486323
Muscle tightness 33.20 13.51 53 100544 14709 110473993
Renal failure 33.12 13.51 101 100496 226473 110262229
Colon cancer 32.89 13.51 56 100541 16387 110472315
Liver function test increased 32.70 13.51 20 100577 88528 110400174
Oedema peripheral 32.52 13.51 171 100426 328489 110160213
Osteonecrosis 32.29 13.51 85 100512 33656 110455046
Bladder dysfunction 32.27 13.51 19 100578 1493 110487209
Lower limb fracture 32.22 13.51 145 100452 75203 110413499
Thermal burn 32.14 13.51 38 100559 7950 110480752
Expanded disability status scale score increased 32.08 13.51 16 100581 902 110487800
Cardio-respiratory arrest 31.82 13.51 35 100562 115801 110372901
Anal incontinence 31.67 13.51 65 100532 21899 110466803
Hypocalcaemia 31.65 13.51 10 100587 65356 110423346
Therapy interrupted 31.62 13.51 4 100593 49818 110438884
Arrested labour 31.12 13.51 10 100587 173 110488529
Obstructive airways disorder 31.07 13.51 3 100594 46146 110442556
Infected skin ulcer 30.95 13.51 27 100570 3940 110484762
Cholelithiasis 30.93 13.51 127 100470 63295 110425407
Papilloma viral infection 30.91 13.51 21 100576 2117 110486585
Status epilepticus 30.69 13.51 80 100517 31491 110457211
Blood creatine phosphokinase increased 30.68 13.51 14 100583 73063 110415639
Animal bite 30.64 13.51 24 100573 3015 110485687
Post procedural complication 30.62 13.51 72 100525 26586 110462116
Neutralising antibodies 30.59 13.51 7 100590 29 110488673
Colon cancer metastatic 30.20 13.51 22 100575 2479 110486223
Demyelination 30.17 13.51 40 100557 9389 110479313
Sedation 29.80 13.51 13 100584 69670 110419032
JC virus infection 29.72 13.51 30 100567 5260 110483442
Bone marrow failure 29.56 13.51 8 100589 57840 110430862
Dysarthria 29.56 13.51 153 100444 83968 110404734
Breast cancer stage I 29.49 13.51 35 100562 7352 110481350
Migraine 29.29 13.51 261 100336 171391 110317311
Goitre 29.18 13.51 32 100565 6172 110482530
Pneumonia 29.00 13.51 1021 99576 875693 109613009
Conversion disorder 28.96 13.51 21 100576 2349 110486353
Serotonin syndrome 28.72 13.51 9 100588 59144 110429558
Myelitis transverse 28.72 13.51 21 100576 2380 110486322
Bladder catheterisation 28.66 13.51 16 100581 1136 110487566
H1N1 influenza 28.64 13.51 23 100574 2995 110485707
Eczema 28.60 13.51 15 100582 72278 110416424
Drug resistance 28.43 13.51 8 100589 56366 110432336
Bile acid malabsorption 28.35 13.51 12 100585 462 110488240
Therapeutic product effect decreased 28.34 13.51 120 100477 244196 110244506
Medical device change 28.32 13.51 12 100585 463 110488239
Depression suicidal 28.28 13.51 28 100569 4796 110483906
Liver disorder 28.23 13.51 54 100543 142189 110346513
Hypomagnesaemia 27.89 13.51 10 100587 60360 110428342
Deep vein thrombosis 27.74 13.51 220 100377 139667 110349035
Infectious mononucleosis 27.70 13.51 20 100577 2222 110486480
Intrathecal pump insertion 27.67 13.51 5 100592 3 110488699
Drug level increased 27.61 13.51 5 100592 47714 110440988
Urinary tract infection staphylococcal 27.50 13.51 15 100582 1018 110487684
Amnesia 27.42 13.51 177 100420 105231 110383471
Malignant melanoma in situ 27.42 13.51 24 100573 3518 110485184
Blood urea increased 27.34 13.51 8 100589 54949 110433753
Partial seizures with secondary generalisation 27.18 13.51 14 100583 845 110487857
Umbilical cord around neck 27.02 13.51 6 100591 21 110488681
Latent tuberculosis 26.95 13.51 25 100572 3952 110484750
Postoperative wound infection 26.82 13.51 50 100547 15703 110472999
Steroid therapy 26.73 13.51 8 100589 108 110488594
Catheter placement 26.72 13.51 23 100574 3297 110485405
Disease recurrence 26.54 13.51 11 100586 60773 110427929
Hypokalaemia 26.18 13.51 82 100515 182366 110306336
Bradycardia 25.95 13.51 65 100532 155452 110333250
Mammoplasty 25.78 13.51 11 100586 432 110488270
Nasal congestion 25.59 13.51 31 100566 98251 110390451
Pelvic fracture 25.45 13.51 46 100551 14108 110474594
Ventricular tachycardia 25.40 13.51 7 100590 50002 110438700
Obesity 25.25 13.51 40 100557 113311 110375391
Autoimmune hepatitis 25.22 13.51 47 100550 14757 110473945
Overdose 25.21 13.51 118 100479 233676 110255026
Medical device removal 25.19 13.51 13 100584 788 110487914
Neurogenic bowel 25.07 13.51 10 100587 330 110488372
Plasma cell myeloma 24.99 13.51 13 100584 62923 110425779
Hypervolaemia 24.97 13.51 7 100590 49453 110439249
Constipation 24.86 13.51 207 100390 357579 110131123
Dysphemia 24.73 13.51 24 100573 4013 110484689
Endometrial adenocarcinoma 24.69 13.51 15 100582 1248 110487454
Pneumonitis 24.68 13.51 20 100577 76511 110412191
Cephalo-pelvic disproportion 24.66 13.51 8 100589 143 110488559
Cholestasis 24.63 13.51 14 100583 64504 110424198
Blindness unilateral 24.62 13.51 37 100560 9749 110478953
Hepatic function abnormal 24.50 13.51 27 100570 89268 110399434
Human papilloma virus test positive 24.49 13.51 12 100585 651 110488051
Adenosquamous cell lung cancer stage IV 24.21 13.51 5 100592 11 110488691
Lupus-like syndrome 24.20 13.51 4 100593 40788 110447914
Leukocytosis 24.08 13.51 105 100492 53723 110434979
Haematuria 24.01 13.51 24 100573 82981 110405721
Osteonecrosis of jaw 23.87 13.51 7 100590 48010 110440692
Urinary tract disorder 23.84 13.51 28 100569 5816 110482886
Lymphocyte count increased 23.74 13.51 31 100566 7172 110481530
Treatment noncompliance 23.63 13.51 19 100578 72971 110415731
Pneumocystis jirovecii pneumonia 23.63 13.51 5 100592 42730 110445972
Proteinuria 23.57 13.51 4 100593 40014 110448688
Foetal heart rate deceleration abnormality 23.54 13.51 8 100589 166 110488536
Therapy partial responder 23.46 13.51 3 100594 37058 110451644
Frustration tolerance decreased 23.39 13.51 34 100563 8697 110480005
Chronic kidney disease 23.31 13.51 21 100576 76270 110412432
Back pain 23.25 13.51 470 100127 370526 110118176
Cellulitis staphylococcal 23.24 13.51 15 100582 1388 110487314
Sciatica 23.16 13.51 30 100567 92369 110396333
Ovarian mass 23.01 13.51 11 100586 565 110488137
Cervical spinal stenosis 22.91 13.51 20 100577 2922 110485780
Ligament rupture 22.88 13.51 23 100574 4012 110484690
Progressive relapsing multiple sclerosis 22.88 13.51 6 100591 48 110488654
Motor dysfunction 22.86 13.51 61 100536 24345 110464357
Knee operation 22.80 13.51 30 100567 6992 110481710
CD4 lymphocytes decreased 22.72 13.51 20 100577 2954 110485748
Adjustment disorder with depressed mood 22.55 13.51 6 100591 43877 110444825
Hepatic cytolysis 22.41 13.51 11 100586 55042 110433660
Calculus bladder 22.40 13.51 16 100581 1748 110486954
Illness 22.38 13.51 25 100572 82146 110406556
Cervix carcinoma stage III 22.35 13.51 6 100591 53 110488649
Monoparesis 22.31 13.51 24 100573 4529 110484173
Paralysis 22.30 13.51 46 100551 15554 110473148
Cardiac failure congestive 22.28 13.51 67 100530 150933 110337769
Clumsiness 22.27 13.51 22 100575 3758 110484944
Squamous cell carcinoma of the cervix 22.17 13.51 9 100588 311 110488391
Infusion site haematoma 22.17 13.51 9 100588 311 110488391
Therapeutic procedure 22.01 13.51 13 100584 1027 110487675
Blindness 22.01 13.51 78 100519 36281 110452421
Restlessness 21.78 13.51 12 100585 56247 110432455
B-cell lymphoma stage I 21.78 13.51 4 100593 3 110488699
Gastrointestinal disorder 21.69 13.51 130 100467 241822 110246880
Agitation 21.50 13.51 44 100553 113007 110375695
Tooth infection 21.29 13.51 56 100541 22160 110466542
Wound sepsis 21.26 13.51 8 100589 225 110488477
Unevaluable event 21.02 13.51 14 100583 59213 110429489
Ovarian cyst 21.01 13.51 42 100555 13888 110474814
Panic attack 21.00 13.51 66 100531 28874 110459828
Tachypnoea 20.99 13.51 5 100592 39390 110449312
Gastric banding 20.93 13.51 6 100591 69 110488633
Bladder repair 20.85 13.51 6 100591 70 110488632
Hepatic enzyme increased 20.80 13.51 189 100408 320703 110167999
Sopor 20.78 13.51 4 100593 36542 110452160
Ventricular fibrillation 20.58 13.51 6 100591 41307 110447395
Hyperhidrosis 20.50 13.51 94 100503 187204 110301498
Pulmonary embolism 20.49 13.51 291 100306 214183 110274519
Hyperemesis gravidarum 20.49 13.51 10 100587 538 110488164
Herpes zoster meningitis 20.47 13.51 8 100589 250 110488452
Flatulence 20.37 13.51 11 100586 52138 110436564
Lung cancer metastatic 20.35 13.51 22 100575 4176 110484526
Fluid retention 20.33 13.51 34 100563 94273 110394429
Spondylitic myelopathy 20.33 13.51 6 100591 77 110488625
Onychomycosis 20.32 13.51 5 100592 38526 110450176
Coagulopathy 20.27 13.51 6 100591 40905 110447797
Blood pressure diastolic decreased 20.25 13.51 4 100593 35881 110452821
Mammogram abnormal 20.15 13.51 10 100587 558 110488144
Circulatory collapse 20.07 13.51 7 100590 42986 110445716
Dry eye 20.05 13.51 13 100584 55780 110432922
Emotional disorder 20.05 13.51 45 100552 16115 110472587
Glioblastoma multiforme 20.05 13.51 14 100583 1476 110487226
Urinary retention 19.99 13.51 120 100477 69563 110419139
Device related infection 19.95 13.51 80 100517 39439 110449263
Quadriparesis 19.95 13.51 23 100574 4684 110484018
Musculoskeletal pain 19.95 13.51 92 100505 182931 110305771
Hyperglycaemia 19.94 13.51 29 100568 85061 110403641
No adverse event 19.83 13.51 125 100472 73714 110414988
Magnetic resonance imaging head abnormal 19.77 13.51 20 100577 3515 110485187
Cardiogenic shock 19.75 13.51 14 100583 57324 110431378
Melanocytic naevus 19.68 13.51 25 100572 5629 110483073
Myalgia 19.66 13.51 120 100477 222261 110266441
Red blood cell nucleated morphology present 19.65 13.51 5 100592 35 110488667
Endometrial cancer 19.62 13.51 17 100580 2459 110486243
Anembryonic gestation 19.54 13.51 9 100588 425 110488277
Colitis ulcerative 19.51 13.51 25 100572 77338 110411364
Plasmablastic lymphoma 19.47 13.51 11 100586 799 110487903
Precancerous cells present 19.41 13.51 13 100584 1280 110487422
Post-traumatic headache 19.41 13.51 6 100591 91 110488611
Cerebrovascular accident 19.38 13.51 251 100346 181033 110307669
Tonsil cancer 19.29 13.51 13 100584 1293 110487409
Gallbladder disorder 19.14 13.51 52 100545 20977 110467725
Ligament sprain 19.11 13.51 44 100553 16024 110472678
Herpes simplex meningitis 19.11 13.51 6 100591 96 110488606
Intervertebral disc operation 19.10 13.51 12 100585 1060 110487642
Rash erythematous 19.07 13.51 28 100569 81804 110406898
Malignant melanoma stage III 19.07 13.51 5 100592 40 110488662
Bladder operation 18.94 13.51 12 100585 1075 110487627
Appendicitis 18.92 13.51 63 100534 28401 110460301
Foetal distress syndrome 18.92 13.51 10 100587 637 110488065
Quadriplegia 18.91 13.51 21 100576 4106 110484596
Hip surgery 18.90 13.51 21 100576 4109 110484593
Oral infection 18.86 13.51 26 100571 6335 110482367
Joint stiffness 18.82 13.51 20 100577 67223 110421479
Chills 18.78 13.51 260 100337 190320 110298382
Imminent abortion 18.74 13.51 4 100593 11 110488691
Depressed level of consciousness 18.67 13.51 47 100550 112231 110376471
Incorrect drug administration rate 18.61 13.51 24 100573 5484 110483218
Intervertebral disc disorder 18.60 13.51 24 100573 5488 110483214
Shock 18.57 13.51 13 100584 53575 110435127
Coronary artery occlusion 18.55 13.51 43 100554 15729 110472973
Foetal heart rate abnormal 18.52 13.51 10 100587 665 110488037
Meningitis 18.51 13.51 36 100561 11666 110477036
Ejection fraction decreased 18.50 13.51 7 100590 40873 110447829
Gastrointestinal viral infection 18.33 13.51 14 100583 1695 110487007
Dysphagia 18.29 13.51 217 100380 153383 110335319
Renal cell carcinoma 18.28 13.51 28 100569 7502 110481200
Neutropenic sepsis 18.27 13.51 3 100594 30743 110457959
Adverse drug reaction 18.25 13.51 161 100436 105398 110383304
Orthostatic hypotension 18.21 13.51 20 100577 66229 110422473
Drowning 18.21 13.51 11 100586 906 110487796
Bladder squamous cell carcinoma stage unspecified 18.01 13.51 3 100594 0 110488702
Urethral valves 18.01 13.51 3 100594 0 110488702
Gestational oedema 18.01 13.51 3 100594 0 110488702
Musculoskeletal procedural complication 18.01 13.51 3 100594 0 110488702
Escherichia sepsis 17.99 13.51 33 100564 10239 110478463
Hepatocellular injury 17.93 13.51 12 100585 50630 110438072
Fibroadenoma of breast 17.93 13.51 10 100587 709 110487993
Feeling hot 17.90 13.51 143 100454 90963 110397739
Breast cyst 17.87 13.51 13 100584 1461 110487241
Foot deformity 17.83 13.51 11 100586 48469 110440233
Nodule 17.67 13.51 4 100593 32627 110456075
Upper gastrointestinal haemorrhage 17.56 13.51 12 100585 50084 110438618
Ependymoma 17.54 13.51 6 100591 127 110488575
Sepsis 17.39 13.51 405 100192 326941 110161761
Fractured coccyx 17.35 13.51 12 100585 1246 110487456
Procedural complication 17.31 13.51 29 100568 8376 110480326
Urinary tract infection enterococcal 17.24 13.51 19 100578 3683 110485019
Breast cancer metastatic 17.21 13.51 34 100563 11147 110477555
Lung adenocarcinoma stage IV 17.19 13.51 9 100588 562 110488140
Respiratory depression 17.17 13.51 4 100593 31997 110456705
Blindness transient 17.14 13.51 24 100573 5932 110482770
Pancreatic carcinoma metastatic 17.07 13.51 20 100577 4144 110484558
Product dose omission issue 17.06 13.51 398 100199 321384 110167318
Pertussis 17.05 13.51 12 100585 1281 110487421
Coeliac disease 17.03 13.51 9 100588 43178 110445524
Rebound effect 17.01 13.51 40 100557 14766 110473936
Invasive breast carcinoma 16.99 13.51 10 100587 785 110487917
Visual acuity reduced 16.95 13.51 66 100531 32107 110456595
Poisoning 16.95 13.51 3 100594 29102 110459600
Hepatic cirrhosis 16.90 13.51 22 100575 67604 110421098
Faeces discoloured 16.78 13.51 5 100592 33943 110454759
Metastatic malignant melanoma 16.76 13.51 18 100579 3391 110485311
Diplegia 16.75 13.51 15 100582 2266 110486436
Brain stem syndrome 16.67 13.51 12 100585 1327 110487375
Hypercalcaemia 16.59 13.51 11 100586 46646 110442056
Neurofibroma 16.55 13.51 4 100593 22 110488680
Spinal cord injury 16.46 13.51 13 100584 1652 110487050
Musculoskeletal stiffness 16.36 13.51 169 100428 279653 110209049
Malignant melanoma stage I 16.32 13.51 6 100591 158 110488544
Cervix carcinoma stage 0 16.28 13.51 7 100590 280 110488422
HIV test positive 16.28 13.51 6 100591 159 110488543
Blood potassium increased 16.25 13.51 5 100592 33244 110455458
Ureterolithiasis 16.17 13.51 20 100577 4382 110484320
Automatic bladder 16.16 13.51 5 100592 76 110488626
Heat exhaustion 16.16 13.51 8 100589 444 110488258
Incoherent 16.11 13.51 28 100569 8330 110480372
Oral pain 15.99 13.51 7 100590 37437 110451265
Skull fracture 15.91 13.51 14 100583 2066 110486636
Lung neoplasm malignant 15.90 13.51 67 100530 33775 110454927
Testicular seminoma (pure) stage I 15.85 13.51 4 100593 27 110488675
Mental status changes 15.79 13.51 121 100476 76001 110412701
Disseminated intravascular coagulation 15.70 13.51 9 100588 41277 110447425
Complication associated with device 15.70 13.51 47 100550 20026 110468676
Corneal decompensation 15.64 13.51 5 100592 85 110488617
Benign neoplasm 15.61 13.51 11 100586 1177 110487525
Vibratory sense increased 15.60 13.51 4 100593 29 110488673
Completed suicide 15.60 13.51 143 100454 242238 110246464
Product administered to patient of inappropriate age 15.59 13.51 27 100570 8009 110480693
Bronchopulmonary aspergillosis 15.51 13.51 4 100593 29859 110458843
Malignant glioma 15.48 13.51 5 100592 88 110488614
Malignant palate neoplasm 15.47 13.51 3 100594 4 110488698
Drug ineffective 15.44 13.51 1183 99414 1519357 108969345
Uterine cancer 15.39 13.51 19 100578 4155 110484547
Ovarian cystectomy 15.38 13.51 5 100592 90 110488612
Female reproductive tract disorder 15.36 13.51 8 100589 494 110488208
Gout 15.36 13.51 7 100590 36559 110452143
Premature rupture of membranes 15.35 13.51 20 100577 4617 110484085
Abdominal adhesions 15.34 13.51 19 100578 4171 110484531
Bronchiectasis 15.30 13.51 7 100590 36486 110452216
Vitamin D decreased 15.14 13.51 34 100563 12181 110476521
Staphylococcal osteomyelitis 15.10 13.51 6 100591 196 110488506
Upper motor neurone lesion 15.07 13.51 7 100590 337 110488365
Nervous system disorder 15.06 13.51 63 100534 31658 110457044
Staphylococcal skin infection 15.05 13.51 13 100584 1872 110486830
Adverse reaction 15.01 13.51 60 100537 29534 110459168
Drug dependence 15.00 13.51 14 100583 50006 110438696
Autoimmune haemolytic anaemia 14.91 13.51 31 100566 10536 110478166
Premature separation of placenta 14.90 13.51 12 100585 1568 110487134
Pulmonary hypertension 14.82 13.51 17 100580 55203 110433499
Hypoalbuminaemia 14.82 13.51 4 100593 28970 110459732
Bipolar I disorder 14.79 13.51 14 100583 2269 110486433
Device extrusion 14.74 13.51 4 100593 37 110488665
Poisoning deliberate 14.72 13.51 3 100594 26328 110462374
Status migrainosus 14.66 13.51 5 100592 105 110488597
Astrocytoma malignant 14.64 13.51 4 100593 38 110488664
Haemorrhage 14.58 13.51 49 100548 106643 110382059
Palpitations 14.55 13.51 85 100512 159127 110329575
Hypophosphataemia 14.49 13.51 6 100591 33176 110455526
Hepatotoxicity 14.48 13.51 22 100575 63378 110425324
Monoplegia 14.45 13.51 20 100577 4889 110483813
Incision site pain 14.45 13.51 16 100581 3119 110485583
Hypoaesthesia oral 14.44 13.51 41 100556 16961 110471741
Infusion site hypersensitivity 14.37 13.51 4 100593 41 110488661
Leukaemia 14.25 13.51 25 100572 7493 110481209
Dermatitis contact 14.23 13.51 36 100561 13917 110474785
Skull fractured base 14.20 13.51 7 100590 385 110488317
Vulvar dysplasia 14.15 13.51 5 100592 117 110488585
Patella fracture 14.07 13.51 14 100583 2412 110486290
Neoplasm malignant 14.06 13.51 69 100528 37074 110451628
Nightmare 14.04 13.51 9 100588 38854 110449848
Transfusion 14.04 13.51 3 100594 25469 110463233
Proteus infection 14.02 13.51 15 100582 2813 110485889
Haematemesis 13.99 13.51 20 100577 59088 110429614
Myocardial infarction 13.96 13.51 249 100348 191834 110296868
Multiple allergies 13.95 13.51 33 100564 12230 110476472
Cholecystitis infective 13.95 13.51 17 100580 3670 110485032
Amyotrophic lateral sclerosis 13.89 13.51 13 100584 2078 110486624
Visual evoked potentials abnormal 13.87 13.51 4 100593 47 110488655
Protein S increased 13.86 13.51 3 100594 9 110488693
Angina pectoris 13.86 13.51 22 100575 62273 110426429
Mouth ulceration 13.83 13.51 14 100583 48124 110440578
Nerve compression 13.80 13.51 31 100566 11106 110477596
Salpingo-oophoritis 13.80 13.51 5 100592 126 110488576
Urinary bladder suspension 13.73 13.51 5 100592 128 110488574
Drug tolerance decreased 13.72 13.51 4 100593 27536 110461166
Metabolic surgery 13.64 13.51 11 100586 1440 110487262
Procedural headache 13.64 13.51 6 100591 254 110488448
Bradycardia foetal 13.62 13.51 5 100592 131 110488571
Thrombosis 13.59 13.51 155 100442 108507 110380195
Cholecystitis 13.55 13.51 53 100544 25829 110462873
Periodontitis 13.54 13.51 20 100577 5188 110483514

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AG03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Monoclonal antibodies
MeSH PA D007155 Immunologic Factors
FDA MoA N0000175774 Integrin Receptor Antagonists
FDA EPC N0000175775 Integrin Receptor Antagonist
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
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:75835 anti-anaemic agent

Related Drugs by ATC class:

L04AG Monoclonal antibodies 14 drugs
alemtuzumabanifrolumabaxatilimab-csfrbelimumabefalizumabemapalumabinebilizumabmuromonab-CD3ocrelizumabofatumumabsibeprenlimab-szsiteprotumumab show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Multiple sclerosis indication 24700007 DOID:2377
Crohn's disease indication 34000006
Progressive multifocal leukoencephalopathy contraindication 22255007 DOID:643




🐶 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
Integrin alpha-4/beta-1 Adhesion ANTIBODY BINDING DRUG LABEL DRUG LABEL
Integrin alpha-4/beta-7 Adhesion ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D06886 KEGG_DRUG
4021508 VUID
N0000148870 NUI
4021508 VANDF
CHEBI:749500 CHEBI
CHEMBL1201607 ChEMBL_ID
6591 IUPHAR_LIGAND_ID
DB00108 DRUGBANK_ID
354770 RXNORM
19083 MMSL
63826 MMSL
d05414 MMSL
008765 NDDF
414804006 SNOMEDCT_US
414805007 SNOMEDCT_US
C1172734 UMLSCUI
D000069442 MESH_DESCRIPTOR_UI
7716 INN_ID
3JB47N2Q2P UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TYRUKO HUMAN PRESCRIPTION DRUG LABEL 1 61314-543 INJECTION 300 mg INTRAVENOUS BLA 30 sections
TYSABRI HUMAN PRESCRIPTION DRUG LABEL 1 64406-008 INJECTION 300 mg INTRAVENOUS BLA 30 sections