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

Approvals:

DateAgencyCompanyOrphan
June 27, 2006 EMA
Nov. 23, 2004 FDA BIOGEN IDEC

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 13035.57 13.26 4298 99392 44180 63341152
Progressive multifocal leukoencephalopathy 3818.38 13.26 1236 102454 11735 63373597
Immune reconstitution inflammatory syndrome 2592.38 13.26 770 102920 5314 63380018
General symptom 1795.36 13.26 488 103202 2320 63383012
Urinary tract infection 1752.05 13.26 2154 101536 262530 63122802
Opportunistic infection 1185.44 13.26 325 103365 1604 63383728
Malaise 1184.79 13.26 2290 101400 413664 62971668
Abortion spontaneous 1179.69 13.26 812 102878 46383 63338949
Drug specific antibody present 1139.85 13.26 378 103312 3881 63381451
Prescribed underdose 884.47 13.26 570 103120 29119 63356213
Poor venous access 750.57 13.26 401 103289 14384 63370948
Balance disorder 692.50 13.26 769 102921 83653 63301679
Gait disturbance 613.71 13.26 1084 102606 182094 63203238
Fall 595.13 13.26 1690 102000 390644 62994688
Off label use 547.35 13.26 210 103480 674252 62711080
Cognitive disorder 518.14 13.26 543 103147 55272 63330060
Central nervous system lesion 502.26 13.26 275 103415 10360 63374972
Magnetic resonance imaging abnormal 490.41 13.26 186 103504 2899 63382433
Memory impairment 478.33 13.26 712 102978 103546 63281786
Maternal exposure during pregnancy 472.43 13.26 1082 102608 218980 63166352
Neoplasm malignant 463.93 13.26 387 103303 29474 63355858
Seizure 462.14 13.26 799 102891 131835 63253497
Secondary progressive multiple sclerosis 419.47 13.26 136 103554 1291 63384041
Herpes zoster 409.87 13.26 585 103105 81877 63303455
Loss of control of legs 398.00 13.26 130 103560 1266 63384066
Breast cancer 390.02 13.26 437 103253 47946 63337386
Caesarean section 385.47 13.26 276 103414 16756 63368576
Muscular weakness 367.31 13.26 691 102999 121662 63263670
Diarrhoea 324.47 13.26 417 103273 714949 62670383
Joint swelling 315.77 13.26 74 103616 327592 63057740
Contraindicated product administered 310.33 13.26 10 103680 217638 63167694
Optic neuritis 306.85 13.26 184 103506 8251 63377081
Toxicity to various agents 296.49 13.26 30 103660 247220 63138112
Pemphigus 283.67 13.26 3 103687 183723 63201609
Rheumatoid arthritis 279.35 13.26 41 103649 253778 63131554
Product use issue 277.20 13.26 22 103668 220498 63164834
Decubitus ulcer 274.36 13.26 186 103504 10334 63374998
Muscle spasticity 269.24 13.26 248 103442 21546 63363786
Condition aggravated 266.50 13.26 164 103526 402053 62983279
Glossodynia 263.22 13.26 6 103684 178870 63206462
Invasive ductal breast carcinoma 256.26 13.26 153 103537 6805 63378527
Drug interaction 249.85 13.26 38 103652 229093 63156239
Hypoaesthesia 248.91 13.26 720 102970 167673 63217659
Abdominal discomfort 240.06 13.26 112 103578 320773 63064559
JC polyomavirus test positive 235.99 13.26 89 103601 1364 63383968
Asthenia 234.21 13.26 1239 102451 382365 63002967
Neutralising antibodies positive 221.64 13.26 57 103633 208 63385124
Drug hypersensitivity 219.49 13.26 117 103573 310570 63074762
Product use in unapproved indication 211.34 13.26 23 103667 179057 63206275
Musculoskeletal disorder 206.16 13.26 209 103481 20435 63364897
Systemic lupus erythematosus 205.47 13.26 45 103645 208873 63176459
Alopecia 200.36 13.26 155 103535 337381 63047951
Influenza 197.79 13.26 502 103188 108220 63277112
Drug delivery device placement 197.66 13.26 45 103645 81 63385251
Visual impairment 195.02 13.26 428 103262 84018 63301314
Peripheral swelling 190.98 13.26 98 103592 265844 63119488
Nasopharyngitis 183.07 13.26 861 102829 253396 63131936
Trigeminal neuralgia 180.09 13.26 96 103594 3423 63381909
Arthralgia 180.05 13.26 417 103273 569293 62816039
Injection site pain 174.75 13.26 9 103681 129791 63255541
Malignant melanoma 173.87 13.26 146 103544 11210 63374122
Acute kidney injury 173.44 13.26 108 103582 263307 63122025
Neurogenic bladder 172.02 13.26 91 103599 3194 63382138
Stress 168.38 13.26 352 103338 66815 63318517
Febrile neutropenia 166.78 13.26 6 103684 118443 63266889
Neutropenia 165.49 13.26 41 103649 174964 63210368
Cystitis 164.09 13.26 310 103380 54681 63330651
Surgery 164.08 13.26 245 103445 35667 63349665
Hypersensitivity 162.64 13.26 922 102768 291763 63093569
Peroneal nerve palsy 161.81 13.26 100 103590 4735 63380597
Hysterectomy 159.81 13.26 129 103561 9370 63375962
Hemiparesis 158.66 13.26 193 103497 23089 63362243
Drug intolerance 157.64 13.26 163 103527 308498 63076834
Swelling 156.42 13.26 132 103558 275246 63110086
Neuromyelitis optica spectrum disorder 155.93 13.26 60 103630 974 63384358
Decreased immune responsiveness 155.53 13.26 98 103592 4803 63380529
Progressive multiple sclerosis 155.25 13.26 62 103628 1116 63384216
Pericarditis 154.96 13.26 17 103673 131562 63253770
Arthropathy 153.53 13.26 97 103593 234695 63150637
Gait inability 148.76 13.26 291 103399 52668 63332664
Mobility decreased 147.18 13.26 484 103206 120675 63264657
Decreased appetite 146.71 13.26 117 103573 250935 63134397
Weight increased 144.47 13.26 128 103562 260664 63124668
Dyspnoea 144.45 13.26 574 103116 660739 62724593
Mental impairment 138.98 13.26 142 103548 14009 63371323
Multiple sclerosis 134.55 13.26 182 103508 24190 63361142
Vein disorder 134.29 13.26 91 103599 5050 63380282
Exposure during pregnancy 129.64 13.26 46 103644 155501 63229831
Epilepsy 127.02 13.26 187 103503 26878 63358454
Road traffic accident 126.43 13.26 220 103470 36412 63348920
Rash 124.15 13.26 484 103206 560387 62824945
Intentional product use issue 120.81 13.26 30 103660 127862 63257470
Ankle fracture 120.02 13.26 147 103543 17708 63367624
Stomatitis 119.12 13.26 39 103651 138686 63246646
Aphasia 118.89 13.26 202 103488 32798 63352534
Coordination abnormal 118.86 13.26 129 103561 13644 63371688
Helicobacter infection 117.22 13.26 9 103681 92776 63292556
Intraductal proliferative breast lesion 116.95 13.26 68 103622 2877 63382455
Therapeutic product effect incomplete 114.94 13.26 31 103659 125025 63260307
Intervertebral disc protrusion 112.97 13.26 165 103525 23544 63361788
Urosepsis 112.55 13.26 145 103545 18379 63366953
Nausea 112.45 13.26 877 102813 853594 62531738
Blister 110.57 13.26 37 103653 129777 63255555
C-reactive protein increased 107.14 13.26 14 103676 94693 63290639
Loss of personal independence in daily activities 106.26 13.26 16 103674 97274 63288058
Death 106.10 13.26 1004 102686 373377 63011955
Lower respiratory tract infection 103.81 13.26 43 103647 132264 63253068
Depression 103.76 13.26 611 103079 195881 63189451
Injection site erythema 102.49 13.26 9 103681 83165 63302167
Cervical dysplasia 101.32 13.26 64 103626 3150 63382182
Treatment failure 100.52 13.26 106 103584 198937 63186395
Hospitalisation 100.13 13.26 11 103679 85070 63300262
Bladder disorder 99.37 13.26 96 103594 8850 63376482
Speech disorder 96.10 13.26 208 103482 40421 63344911
Uterine leiomyoma 93.43 13.26 94 103596 9104 63376228
Muscle injury 93.06 13.26 3 103687 65342 63319990
Hip fracture 92.71 13.26 170 103520 29304 63356028
Relapsing-remitting multiple sclerosis 91.71 13.26 35 103655 555 63384777
Breech presentation 91.29 13.26 43 103647 1171 63384161
Disease progression 88.37 13.26 45 103645 122713 63262619
Central venous catheterisation 87.60 13.26 54 103636 2545 63382787
Pancytopenia 87.25 13.26 25 103665 96908 63288424
Discomfort 86.92 13.26 87 103603 167287 63218045
Ectopic pregnancy 85.67 13.26 53 103637 2514 63382818
Bronchitis 85.32 13.26 417 103273 124518 63260814
Breast cancer female 85.31 13.26 108 103582 13451 63371881
Diplopia 85.14 13.26 145 103545 23583 63361749
Thrombocytopenia 83.86 13.26 74 103616 151083 63234249
Adverse reaction 83.59 13.26 93 103597 10110 63375222
Anaphylactic shock 82.93 13.26 143 103547 23490 63361842
Upper respiratory tract infection 82.48 13.26 308 103382 81739 63303593
Completed suicide 82.41 13.26 70 103620 145603 63239729
Hyponatraemia 82.08 13.26 40 103650 111860 63273472
Prolonged labour 81.59 13.26 32 103658 548 63384784
Thyroid cancer 81.51 13.26 70 103620 5541 63379791
Nephrolithiasis 80.62 13.26 198 103492 41786 63343546
Urinary incontinence 80.45 13.26 168 103522 31846 63353486
Blood creatinine increased 80.29 13.26 22 103668 87822 63297510
Abdominal pain 78.52 13.26 233 103457 293223 63092109
White blood cell count increased 77.82 13.26 214 103476 48347 63336985
Atrial fibrillation 77.82 13.26 47 103643 116589 63268743
Electrocardiogram QT prolonged 77.43 13.26 5 103685 59525 63325807
No adverse event 77.11 13.26 193 103497 41212 63344120
Platelet count decreased 75.80 13.26 48 103642 116074 63269258
Folliculitis 75.79 13.26 12 103678 70305 63315027
Dyspepsia 75.77 13.26 36 103654 102160 63283172
Cervix carcinoma 75.16 13.26 52 103638 2985 63382347
Mental disorder 74.68 13.26 144 103546 25775 63359557
Muscle spasms 73.83 13.26 472 103218 155678 63229654
Wrong technique in product usage process 73.51 13.26 8 103682 62332 63323000
Haemoglobin decreased 72.84 13.26 78 103612 145407 63239925
Intentional overdose 72.77 13.26 16 103674 74136 63311196
Lymphocytosis 72.32 13.26 49 103641 2718 63382614
Gastric bypass 72.27 13.26 42 103648 1775 63383557
Renal impairment 72.11 13.26 27 103663 88328 63297004
Vomiting 70.74 13.26 580 103110 559037 62826295
Wound 70.69 13.26 98 103592 163165 63222167
JC virus granule cell neuronopathy 70.23 13.26 20 103670 116 63385216
Therapeutic response decreased 69.81 13.26 9 103681 61516 63323816
Staphylococcal infection 69.30 13.26 185 103505 41071 63344261
Vision blurred 67.96 13.26 314 103376 91610 63293722
Lower limb fracture 67.87 13.26 133 103557 24088 63361244
Pregnancy 67.86 13.26 171 103519 36665 63348667
Post lumbar puncture syndrome 66.14 13.26 28 103662 588 63384744
Leukopenia 65.85 13.26 22 103668 77268 63308064
Temperature intolerance 65.48 13.26 77 103613 8887 63376445
Herpes zoster necrotising retinopathy 65.03 13.26 12 103678 0 63385332
Drug abuse 64.72 13.26 19 103671 72499 63312833
Kidney infection 64.63 13.26 127 103563 23049 63362283
Pleural effusion 64.39 13.26 36 103654 93174 63292158
Dysgraphia 63.07 13.26 48 103642 3198 63382134
Neuropathy peripheral 62.61 13.26 56 103634 113611 63271721
Psoriasis 62.39 13.26 32 103658 86925 63298407
Intentional product misuse 62.15 13.26 12 103678 60905 63324427
Dyspnoea exertional 61.26 13.26 12 103678 60290 63325042
Injection site reaction 60.83 13.26 11 103679 58513 63326819
Incorrect dose administered 60.78 13.26 12 103678 59956 63325376
Cardiac failure 60.76 13.26 35 103655 89107 63296225
Therapy non-responder 60.60 13.26 24 103666 75877 63309455
Wheezing 60.37 13.26 41 103649 95554 63289778
Oxygen saturation decreased 60.06 13.26 35 103655 88550 63296782
Red blood cell sedimentation rate increased 59.33 13.26 3 103687 43979 63341353
White blood cell count decreased 58.72 13.26 85 103605 139019 63246313
Focal dyscognitive seizures 58.53 13.26 44 103646 2877 63382455
Blood cholesterol increased 58.49 13.26 41 103649 93991 63291341
Infusion site extravasation 57.75 13.26 78 103612 10348 63374984
Cough 57.54 13.26 264 103426 292479 63092853
Anaemia 56.86 13.26 266 103424 293164 63092168
Multiple organ dysfunction syndrome 56.19 13.26 12 103678 56740 63328592
Constipation 55.62 13.26 185 103505 224758 63160574
Gallbladder operation 55.38 13.26 39 103651 2304 63383028
Irritable bowel syndrome 55.26 13.26 33 103657 82379 63302953
Ataxia 54.70 13.26 93 103597 15102 63370230
Weight decreased 54.17 13.26 250 103440 276548 63108784
Therapeutic product effect decreased 54.11 13.26 150 103540 193037 63192295
Infection 53.94 13.26 592 103098 228581 63156751
Band sensation 53.84 13.26 27 103663 846 63384486
Neutrophil count decreased 53.70 13.26 13 103677 56393 63328939
Inflammation 53.69 13.26 34 103656 82239 63303093
Sensory disturbance 53.67 13.26 87 103603 13585 63371747
Amnesia 53.65 13.26 206 103484 55379 63329953
Viral infection 53.05 13.26 153 103537 35510 63349822
Hypoxia 52.74 13.26 16 103674 59776 63325556
Unevaluable event 52.68 13.26 10 103680 51376 63333956
Lung adenocarcinoma 52.32 13.26 50 103640 4547 63380785
Papillary thyroid cancer 52.04 13.26 37 103653 2219 63383113
Liver injury 51.95 13.26 17 103673 60503 63324829
Dysstasia 51.93 13.26 110 103580 21056 63364276
Pharyngitis streptococcal 51.90 13.26 75 103615 10597 63374735
Hypotension 51.71 13.26 249 103441 272355 63112977
Migraine 51.69 13.26 317 103373 103029 63282303
Invasive lobular breast carcinoma 50.31 13.26 26 103664 869 63384463
Head injury 50.27 13.26 127 103563 27269 63358063
Fibromyalgia 50.10 13.26 35 103655 80385 63304947
Medication error 49.87 13.26 12 103678 52272 63333060
Escherichia urinary tract infection 49.54 13.26 78 103612 11884 63373448
Appendicitis perforated 49.25 13.26 33 103657 1797 63383535
Partial seizures 49.15 13.26 54 103636 5788 63379544
Clostridial infection 48.53 13.26 47 103643 4345 63380987
Central nervous system lymphoma 47.57 13.26 30 103660 1472 63383860
Meningioma 47.56 13.26 44 103646 3841 63381491
Dry mouth 47.05 13.26 35 103655 77828 63307504
Upper limb fracture 47.02 13.26 99 103591 18869 63366463
Blood pressure systolic increased 46.97 13.26 10 103680 47387 63337945
Primary progressive multiple sclerosis 46.67 13.26 14 103676 100 63385232
Adenocarcinoma of colon 46.40 13.26 36 103654 2468 63382864
Neurological symptom 46.15 13.26 52 103638 5731 63379601
Frustration tolerance decreased 46.10 13.26 57 103633 6931 63378401
Oedema 45.95 13.26 55 103635 97567 63287765
Foetal exposure timing unspecified 45.53 13.26 17 103673 253 63385079
Hypertension 45.26 13.26 269 103421 279034 63106298
Meningitis herpes 44.96 13.26 16 103674 206 63385126
Lactic acidosis 44.92 13.26 5 103685 38282 63347050
Tremor 44.74 13.26 369 103321 131870 63253462
Gastroenteritis viral 44.67 13.26 111 103579 23589 63361743
Pain 44.58 13.26 898 102792 739730 62645602
Antibody test positive 43.92 13.26 36 103654 2671 63382661
Drug reaction with eosinophilia and systemic symptoms 43.53 13.26 3 103687 33833 63351499
Basal cell carcinoma 43.50 13.26 122 103568 27869 63357463
Chronic lymphocytic leukaemia 42.91 13.26 35 103655 2579 63382753
Hemianaesthesia 42.56 13.26 18 103672 377 63384955
Hypoglycaemia 41.76 13.26 23 103667 60042 63325290
International normalised ratio increased 41.72 13.26 12 103678 46413 63338919
Abortion missed 41.53 13.26 29 103661 1690 63383642
Ovarian cancer 41.45 13.26 50 103640 5926 63379406
Productive cough 41.41 13.26 26 103664 63182 63322150
Epistaxis 41.04 13.26 35 103655 72690 63312642
Endometriosis 41.04 13.26 47 103643 5273 63380059
Ophthalmic herpes zoster 41.04 13.26 31 103659 2042 63383290
Bladder dysfunction 40.93 13.26 23 103667 911 63384421
Agraphia 40.63 13.26 10 103680 29 63385303
Bipolar disorder 40.26 13.26 57 103633 7903 63377429
Urticaria 40.23 13.26 431 103259 165371 63219961
Rhabdomyolysis 40.17 13.26 11 103679 43940 63341392
Breast cancer in situ 40.12 13.26 27 103663 1481 63383851
Abdominal pain upper 40.04 13.26 187 103503 206257 63179075
Influenza like illness 39.97 13.26 215 103475 66609 63318723
Metabolic acidosis 39.86 13.26 12 103678 45057 63340275
Relapsing multiple sclerosis 39.50 13.26 14 103676 178 63385154
Sleep disorder 39.41 13.26 45 103645 81521 63303811
Dysarthria 39.35 13.26 156 103534 42555 63342777
Cardio-respiratory arrest 38.82 13.26 25 103665 59934 63325398
Paraparesis 38.81 13.26 31 103659 2217 63383115
Malignant melanoma in situ 38.29 13.26 22 103668 910 63384422
Hyperhidrosis 38.00 13.26 74 103616 107762 63277570
Uhthoff's phenomenon 37.93 13.26 7 103683 0 63385332
Dry skin 37.82 13.26 23 103667 56864 63328468
Meningoencephalitis herpetic 37.65 13.26 24 103666 1200 63384132
Motor dysfunction 37.60 13.26 65 103625 10696 63374636
Fibula fracture 37.45 13.26 37 103653 3505 63381827
Interstitial lung disease 37.18 13.26 28 103662 61880 63323452
Injury 36.95 13.26 39 103651 73208 63312124
Vaginal infection 36.80 13.26 53 103637 7465 63377867
Nasal congestion 36.57 13.26 32 103658 65628 63319704
Prescribed overdose 36.41 13.26 6 103684 34147 63351185
Blindness 36.13 13.26 97 103593 21602 63363730
Post procedural infection 36.06 13.26 59 103631 9283 63376049
Expanded disability status scale score increased 35.49 13.26 18 103672 578 63384754
Tachycardia 35.15 13.26 89 103601 118067 63267265
Blindness unilateral 35.04 13.26 47 103643 6194 63379138
Colon cancer 34.95 13.26 60 103630 9818 63375514
Female reproductive tract disorder 34.72 13.26 16 103674 414 63384918
Foetal malposition 34.69 13.26 10 103680 61 63385271
Urinary tract infection pseudomonal 34.68 13.26 20 103670 833 63384499
Myelitis 34.67 13.26 24 103666 1379 63383953
Cellulitis 34.63 13.26 241 103449 81717 63303615
Somnolence 34.56 13.26 162 103528 178523 63206809
Type 2 diabetes mellitus 34.52 13.26 32 103658 63836 63321496
Gastrooesophageal reflux disease 34.25 13.26 65 103625 95574 63289758
Foot fracture 34.04 13.26 101 103589 23813 63361519
Paraesthesia 33.97 13.26 399 103291 156567 63228765
Therapy interrupted 33.94 13.26 6 103684 32449 63352883
Gastrointestinal haemorrhage 33.85 13.26 50 103640 81126 63304206
Skin exfoliation 33.80 13.26 14 103676 43088 63342244
Hypokalaemia 33.41 13.26 75 103615 103729 63281603
Herpes zoster meningitis 33.39 13.26 10 103680 71 63385261
Autoimmune hepatitis 33.20 13.26 54 103636 8456 63376876
Herpes simplex meningitis 33.05 13.26 9 103681 43 63385289
Cholecystectomy 32.83 13.26 61 103629 10616 63374716
Female genital operation 32.55 13.26 8 103682 23 63385309
Tibia fracture 32.55 13.26 41 103649 5079 63380253
Urostomy 32.16 13.26 7 103683 9 63385323
Inappropriate schedule of product administration 31.95 13.26 77 103613 103888 63281444
Meningitis viral 31.93 13.26 23 103667 1408 63383924
Therapeutic procedure 31.73 13.26 19 103671 849 63384483
Arthropod bite 31.63 13.26 51 103639 7927 63377405
Oedema peripheral 31.48 13.26 181 103509 189330 63196002
Incorrect route of product administration 31.18 13.26 4 103686 27448 63357884
Steroid therapy 31.10 13.26 11 103679 139 63385193
Melaena 30.93 13.26 6 103684 30359 63354973
Lymphocyte count increased 30.91 13.26 33 103657 3425 63381907
Pneumonia aspiration 30.89 13.26 125 103565 34415 63350917
Ascites 30.71 13.26 14 103676 40714 63344618
Hepatic enzyme increased 30.61 13.26 199 103491 202129 63183203
Appendicitis 30.46 13.26 51 103639 8178 63377154
Back disorder 30.26 13.26 60 103630 10957 63374375
Post procedural complication 30.13 13.26 78 103612 16996 63368336
Vertigo 30.12 13.26 184 103506 59703 63325629
Major depression 30.09 13.26 50 103640 7968 63377364
Myalgia 30.04 13.26 130 103560 146399 63238933
Abdominal distension 30.03 13.26 60 103630 86555 63298777
Papilloma viral infection 30.03 13.26 23 103667 1547 63383785
Rectal haemorrhage 29.67 13.26 22 103668 49008 63336324
Headache 29.63 13.26 1290 102400 631951 62753381
Cholestasis 29.59 13.26 6 103684 29428 63355904
Pulmonary fibrosis 29.53 13.26 14 103676 39795 63345537
Flushing 29.52 13.26 217 103473 74870 63310462
Arrested labour 29.40 13.26 12 103678 229 63385103
Chronic kidney disease 29.29 13.26 19 103671 45379 63339953
Depressed level of consciousness 29.18 13.26 35 103655 62043 63323289
Blood creatine phosphokinase increased 28.99 13.26 7 103683 30423 63354909
Injection site haemorrhage 28.97 13.26 3 103687 24311 63361021
Delirium 28.91 13.26 24 103666 50517 63334815
Low birth weight baby 28.85 13.26 46 103644 7083 63378249
Red blood cell nucleated morphology present 28.78 13.26 7 103683 19 63385313
Neutralising antibodies 28.76 13.26 8 103682 42 63385290
Blindness transient 28.75 13.26 33 103657 3711 63381621
Serotonin syndrome 28.52 13.26 6 103684 28676 63356656
Drug ineffective for unapproved indication 28.48 13.26 10 103680 34053 63351279
Blood pressure increased 28.44 13.26 152 103538 161910 63223422
Impaired healing 28.41 13.26 80 103610 102462 63282870
Sedation 28.25 13.26 14 103676 38795 63346537
Hypervolaemia 28.14 13.26 6 103684 28407 63356925
Incontinence 28.01 13.26 60 103630 11572 63373760
Cardiac failure congestive 27.97 13.26 69 103621 92364 63292968
Herpes simplex encephalitis 27.87 13.26 13 103677 346 63384986
Mammoplasty 27.85 13.26 15 103675 546 63384786
Bursitis 27.52 13.26 13 103677 37028 63348304
Human papilloma virus test positive 27.50 13.26 15 103675 560 63384772
Sepsis 27.49 13.26 376 103314 152747 63232585
Stevens-Johnson syndrome 27.47 13.26 4 103686 24946 63360386
Endometrial cancer 27.46 13.26 30 103660 3195 63382137
Bone marrow failure 27.39 13.26 7 103683 29283 63356049
Blood urea increased 27.32 13.26 5 103685 26374 63358958
Frequent bowel movements 27.02 13.26 3 103687 23019 63362313
Fibroadenoma of breast 27.00 13.26 14 103676 471 63384861
Depression suicidal 27.00 13.26 23 103667 1800 63383532
Plasmablastic lymphoma 26.95 13.26 11 103679 210 63385122
Colon cancer metastatic 26.83 13.26 19 103671 1132 63384200
Accidental exposure to product 26.71 13.26 6 103684 27399 63357933
Progressive relapsing multiple sclerosis 26.52 13.26 7 103683 29 63385303
Tenderness 26.35 13.26 3 103687 22575 63362757
Pneumonia 26.34 13.26 952 102738 455815 62929517
Pineal gland cyst 26.28 13.26 6 103684 11 63385321
Oral pain 26.15 13.26 7 103683 28387 63356945
Anal incontinence 26.02 13.26 64 103626 13512 63371820
Fluid retention 25.64 13.26 36 103654 59650 63325682
Fatigue 25.59 13.26 1729 101961 886299 62499033
Pruritus allergic 25.59 13.26 21 103669 1561 63383771
Hypocalcaemia 25.36 13.26 10 103680 31703 63353629
Myelitis transverse 25.29 13.26 19 103671 1241 63384091
Osteoarthritis 25.23 13.26 76 103614 95267 63290065
JC polyomavirus test 25.13 13.26 7 103683 37 63385295
Dry eye 25.04 13.26 18 103672 40743 63344589
Night sweats 24.61 13.26 26 103664 48788 63336544
Plasma cell myeloma 24.60 13.26 14 103676 35891 63349441
Macular degeneration 24.44 13.26 5 103685 24371 63360961
Malignant melanoma stage I 24.38 13.26 7 103683 42 63385290
Generalised tonic-clonic seizure 24.37 13.26 103 103587 28913 63356419
Renal failure 24.34 13.26 104 103586 117548 63267784
Bradycardia 24.31 13.26 52 103638 73175 63312157
Drug level increased 24.23 13.26 4 103686 22732 63362600
Hypercalcaemia 24.23 13.26 8 103682 28314 63357018
Blood pressure diastolic decreased 24.18 13.26 4 103686 22702 63362630
Pulmonary arterial hypertension 23.99 13.26 4 103686 22573 63362759
Mouth ulceration 23.86 13.26 12 103678 32972 63352360
Infectious mononucleosis 23.81 13.26 22 103668 1917 63383415
Joint stiffness 23.81 13.26 20 103670 41849 63343483
Muscle tightness 23.77 13.26 57 103633 11843 63373489
Palpitations 23.75 13.26 99 103591 112671 63272661
Product administration error 23.73 13.26 4 103686 22393 63362939
Postoperative wound infection 23.65 13.26 54 103636 10871 63374461
Ejection fraction decreased 23.64 13.26 4 103686 22328 63363004
Grip strength decreased 23.57 13.26 4 103686 22283 63363049
Bladder catheterisation 23.41 13.26 11 103679 298 63385034
Pyelonephritis 23.35 13.26 73 103617 17705 63367627
Neuralgia 23.32 13.26 94 103596 25832 63359500
Knee operation 23.24 13.26 38 103652 5975 63379357
CD4 lymphocytes decreased 23.20 13.26 19 103671 1408 63383924
Flatulence 23.11 13.26 14 103676 34688 63350644
Hypomagnesaemia 23.08 13.26 9 103681 28728 63356604
Circulatory collapse 23.06 13.26 4 103686 21934 63363398
Dysphemia 22.98 13.26 25 103665 2650 63382682
Musculoskeletal stiffness 22.92 13.26 192 103498 184426 63200906
Precancerous cells present 22.74 13.26 19 103671 1448 63383884
Catheter placement 22.57 13.26 23 103667 2261 63383071
Ventricular tachycardia 22.47 13.26 3 103687 19976 63365356
Tubulointerstitial nephritis 22.36 13.26 3 103687 19900 63365432
Anembryonic gestation 22.31 13.26 13 103677 552 63384780
Rhinorrhoea 22.24 13.26 46 103644 65531 63319801
Lung cancer metastatic 21.97 13.26 24 103666 2556 63382776
Bile acid malabsorption 21.94 13.26 9 103681 174 63385158
Hyperemesis gravidarum 21.75 13.26 13 103677 579 63384753
Metastases to bone 21.73 13.26 4 103686 21015 63364317
Haemorrhagic adrenal infarction 21.65 13.26 6 103684 31 63385301
Conversion disorder 21.64 13.26 20 103670 1744 63383588
Perinatal stroke 21.62 13.26 5 103685 10 63385322
Paralysis 21.50 13.26 49 103641 9851 63375481
Concussion 21.48 13.26 47 103643 9197 63376135
Hyperglycaemia 21.44 13.26 22 103668 41845 63343487
Adenosquamous cell lung cancer stage IV 21.30 13.26 5 103685 11 63385321
Hepatocellular injury 21.30 13.26 9 103681 27372 63357960
Quadriplegia 21.29 13.26 20 103670 1780 63383552
Uterine cancer 21.19 13.26 32 103658 4701 63380631
Mammogram abnormal 21.15 13.26 14 103676 747 63384585
Panic attack 20.92 13.26 82 103608 22249 63363083
Foetal heart rate deceleration abnormality 20.87 13.26 12 103678 497 63384835
Rebound effect 20.84 13.26 31 103659 4495 63380837
Infusion site haematoma 20.81 13.26 10 103680 285 63385047
Drug ineffective 20.78 13.26 1449 102241 1043316 62342016
Gastroenteritis cryptosporidial 20.75 13.26 7 103683 76 63385256
Colour blindness acquired 20.66 13.26 7 103683 77 63385255
Impaired self-care 20.64 13.26 20 103670 1850 63383482
Immune system disorder 20.62 13.26 48 103642 9786 63375546
Disease recurrence 20.57 13.26 10 103680 28020 63357312
Diplegia 20.57 13.26 16 103674 1101 63384231
Asthma 20.55 13.26 123 103567 127438 63257894
Product administered to patient of inappropriate age 20.51 13.26 26 103664 3242 63382090
Drug resistance 20.47 13.26 6 103684 22927 63362405
Haematochezia 20.41 13.26 35 103655 53509 63331823
Neurogenic bowel 20.40 13.26 8 103682 137 63385195
Gastric banding 20.34 13.26 7 103683 81 63385251
Metastatic malignant melanoma 20.32 13.26 17 103673 1298 63384034
Micturition urgency 20.25 13.26 47 103643 9564 63375768
Paternal exposure before pregnancy 20.23 13.26 6 103684 41 63385291
Herpes virus infection 19.99 13.26 34 103656 5522 63379810
Medical device change 19.72 13.26 10 103680 321 63385011
Post-traumatic headache 19.71 13.26 5 103685 17 63385315
Orthostatic hypotension 19.68 13.26 18 103672 36142 63349190
Sinusitis 19.68 13.26 497 103193 226156 63159176
Cervical spinal stenosis 19.61 13.26 21 103669 2187 63383145
Overdose 19.59 13.26 109 103581 114969 63270363
Pulmonary hypertension 19.59 13.26 19 103671 37104 63348228
Status epilepticus 19.50 13.26 62 103628 15171 63370161
Tooth infection 19.45 13.26 69 103621 17851 63367481
Magnetic resonance imaging head abnormal 19.40 13.26 20 103670 1993 63383339
Demyelination 19.39 13.26 38 103652 6882 63378450
Device malfunction 19.34 13.26 3 103687 17854 63367478
Quadriparesis 19.27 13.26 20 103670 2009 63383323
Abortion 19.17 13.26 22 103668 2474 63382858
Animal bite 19.15 13.26 24 103666 2958 63382374
Wound sepsis 19.12 13.26 8 103682 163 63385169
Ligament sprain 19.12 13.26 55 103635 12745 63372587
Monoparesis 19.09 13.26 18 103672 1609 63383723
Corneal decompensation 19.09 13.26 6 103684 51 63385281
Autoimmune haemolytic anaemia 19.05 13.26 30 103660 4571 63380761
Joint range of motion decreased 19.05 13.26 15 103675 32413 63352919
Lung adenocarcinoma stage IV 19.03 13.26 8 103682 165 63385167
Pain in jaw 18.91 13.26 26 103664 43470 63341862
Insomnia 18.87 13.26 243 103447 215009 63170323
Ovarian cystectomy 18.72 13.26 8 103682 172 63385160
Erythema 18.69 13.26 190 103500 175561 63209771
Dysplastic naevus 18.60 13.26 8 103682 175 63385157
Face oedema 18.58 13.26 5 103685 20207 63365125
Haemoptysis 18.56 13.26 12 103678 28714 63356618
Calculus bladder 18.56 13.26 12 103678 615 63384717
Injection site mass 18.35 13.26 4 103686 18652 63366680
Lung neoplasm malignant 18.31 13.26 72 103618 19561 63365771
Breast cancer stage I 18.30 13.26 37 103653 6852 63378480
Hypercholesterolaemia 18.29 13.26 6 103684 21328 63364004
Cervix carcinoma stage III 18.22 13.26 6 103684 60 63385272
Foetal distress syndrome 18.04 13.26 16 103674 1322 63384010
Ligament rupture 18.00 13.26 25 103665 3405 63381927
Blood glucose increased 17.97 13.26 73 103617 83683 63301649
Incision site pain 17.95 13.26 15 103675 1143 63384189
Blood pressure fluctuation 17.91 13.26 30 103660 46287 63339045
Benign neoplasm 17.88 13.26 14 103676 973 63384359
Post procedural pneumonia 17.86 13.26 5 103685 27 63385305
Feeling abnormal 17.85 13.26 341 103349 148051 63237281
Appendicectomy 17.84 13.26 23 103667 2916 63382416
Necrotising retinitis 17.66 13.26 10 103680 402 63384930
Partial seizures with secondary generalisation 17.64 13.26 10 103680 403 63384929
Pneumonitis 17.48 13.26 19 103671 35203 63350129
Hepatic function abnormal 17.39 13.26 21 103669 37121 63348211
Dysgeusia 17.38 13.26 31 103659 46679 63338653
Blood lactate dehydrogenase increased 17.34 13.26 8 103682 23108 63362224
Cephalo-pelvic disproportion 17.32 13.26 8 103682 208 63385124
Cervicitis human papilloma virus 17.29 13.26 4 103686 8 63385324
Sputum discoloured 17.14 13.26 3 103687 16344 63368988
Endometrial adenocarcinoma 17.10 13.26 15 103675 1221 63384111
Infected skin ulcer 16.98 13.26 20 103670 2312 63383020
Adverse drug reaction 16.95 13.26 202 103488 79512 63305820
Status migrainosus 16.90 13.26 7 103683 139 63385193
Restlessness 16.83 13.26 14 103676 29439 63355893
Gastrointestinal viral infection 16.78 13.26 15 103675 1252 63384080
Squamous cell carcinoma of the cervix 16.78 13.26 9 103681 325 63385007
Feeling hot 16.74 13.26 140 103550 50214 63335118
Cardiac arrest 16.67 13.26 86 103604 92459 63292873
Latent tuberculosis 16.64 13.26 21 103669 2606 63382726
Product substitution issue 16.63 13.26 3 103687 15993 63369339
Incorrect drug administration rate 16.63 13.26 26 103664 3936 63381396
Cholecystitis infective 16.57 13.26 17 103673 1685 63383647
Haematuria 16.49 13.26 14 103676 29143 63356189
General physical health deterioration 16.33 13.26 231 103459 201171 63184161
Gestational oedema 16.26 13.26 3 103687 0 63385332
Nutritional supplementation 16.26 13.26 3 103687 0 63385332
Iron metabolism disorder 16.26 13.26 3 103687 0 63385332
Intracranial haemangioma 16.26 13.26 3 103687 0 63385332
Pruritus 16.17 13.26 458 103232 360995 63024337
Joint effusion 16.10 13.26 4 103686 17056 63368276
Inappropriate antidiuretic hormone secretion 15.86 13.26 3 103687 15459 63369873
Communication disorder 15.86 13.26 20 103670 2480 63382852
Goitre 15.82 13.26 32 103658 5929 63379403
Emotional disorder 15.82 13.26 53 103637 13326 63372006
Urinary retention 15.81 13.26 94 103596 30207 63355125
Pulmonary oedema 15.80 13.26 42 103648 54831 63330501
Respiratory tract infection 15.80 13.26 119 103571 41364 63343968
Visual acuity reduced 15.71 13.26 74 103616 21752 63363580
Metastatic squamous cell carcinoma 15.60 13.26 8 103682 263 63385069
Accident 15.55 13.26 32 103658 6000 63379332
Procedural complication 15.40 13.26 30 103660 5409 63379923
Proteinuria 15.37 13.26 6 103684 19139 63366193
Nervous system disorder 15.28 13.26 66 103624 18700 63366632
Imminent abortion 15.26 13.26 4 103686 16 63385316
Vulvar dysplasia 15.23 13.26 7 103683 180 63385152
Clumsiness 15.22 13.26 18 103672 2089 63383243
Adenomyosis 15.20 13.26 10 103680 528 63384804
Pertussis 15.18 13.26 11 103679 680 63384652
Rash erythematous 15.12 13.26 29 103661 42481 63342851
Transverse presentation 15.07 13.26 4 103686 17 63385315
Bladder repair 15.02 13.26 6 103684 108 63385224
Withdrawal syndrome 14.88 13.26 7 103683 19990 63365342
Tooth abscess 14.87 13.26 56 103634 14913 63370419
Multiple allergies 14.86 13.26 53 103637 13749 63371583
Bone pain 14.85 13.26 43 103647 54598 63330734
Drug tolerance decreased 14.83 13.26 5 103685 17468 63367864
Metabolic surgery 14.83 13.26 14 103676 1254 63384078
Paraplegia 14.81 13.26 20 103670 2652 63382680
Oral infection 14.80 13.26 28 103662 4940 63380392
Urinary tract disorder 14.78 13.26 21 103669 2920 63382412
Brain neoplasm 14.77 13.26 26 103664 4340 63380992
Synovial sarcoma 14.76 13.26 5 103685 55 63385277
Medical device removal 14.74 13.26 14 103676 1263 63384069
Uterine cyst 14.74 13.26 9 103681 417 63384915
Brain stem syndrome 14.66 13.26 9 103681 421 63384911
Postoperative abscess 14.56 13.26 9 103681 426 63384906
Astrocytoma malignant 14.54 13.26 4 103686 20 63385312
Cholelithiasis 14.53 13.26 122 103568 43803 63341529
Ovarian neoplasm 14.52 13.26 12 103678 901 63384431
Haemorrhage 14.51 13.26 51 103639 60971 63324361
H1N1 influenza 14.50 13.26 16 103674 1723 63383609
Eye irritation 14.44 13.26 9 103681 21962 63363370
Cellulitis staphylococcal 14.40 13.26 11 103679 737 63384595
Thermal burn 14.34 13.26 31 103659 6015 63379317
Premature delivery 14.31 13.26 17 103673 30264 63355068
Red blood cell count decreased 14.22 13.26 28 103662 40617 63344715
Vestibular neuronitis 14.19 13.26 10 103680 591 63384741
Nucleated red cells 14.18 13.26 3 103687 3 63385329
Post procedural sepsis 14.18 13.26 7 103683 212 63385120
Leukaemia 14.16 13.26 25 103665 4183 63381149
Gastrointestinal lymphoma 14.15 13.26 5 103685 63 63385269
Bladder spasm 14.14 13.26 16 103674 1772 63383560
Angina pectoris 14.09 13.26 17 103673 30061 63355271
Ovarian mass 14.08 13.26 11 103679 762 63384570
Cervical incompetence 13.96 13.26 10 103680 607 63384725
Breast cyst 13.90 13.26 16 103674 1805 63383527
Lip dry 13.90 13.26 4 103686 15466 63369866
Vulvovaginal mycotic infection 13.74 13.26 29 103661 5537 63379795
Lumbar puncture 13.71 13.26 6 103684 137 63385195
Disseminated intravascular coagulation 13.68 13.26 7 103683 19044 63366288
Foetal heart rate abnormal 13.67 13.26 10 103680 627 63384705
Spondylitic myelopathy 13.66 13.26 4 103686 26 63385306
Premature separation of placenta 13.62 13.26 16 103674 1845 63383487
Shock 13.60 13.26 11 103679 23452 63361880
Tumefactive multiple sclerosis 13.54 13.26 5 103685 72 63385260
Drowning 13.53 13.26 9 103681 484 63384848
Agitation 13.51 13.26 51 103639 59706 63325626
Cervix carcinoma stage 0 13.41 13.26 8 103682 355 63384977
Cardiomegaly 13.37 13.26 6 103684 17608 63367724
Underweight 13.36 13.26 12 103678 1008 63384324
Hip arthroplasty 13.32 13.26 37 103653 47609 63337723
Sinus tachycardia 13.30 13.26 12 103678 24256 63361076
Skin discolouration 13.28 13.26 26 103664 37802 63347530

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 4680 16.19 1254 29033 11879 34914765
Progressive multifocal leukoencephalopathy 1902.97 16.19 584 29703 9180 34917464
Immune reconstitution inflammatory syndrome 962.19 16.19 340 29947 8419 34918225
Urinary tract infection 746.86 16.19 602 29685 83479 34843165
General symptom 679.87 16.19 157 30130 727 34925917
Opportunistic infection 443.91 16.19 127 30160 1531 34925113
Prescribed underdose 357.20 16.19 168 30119 8765 34917879
Drug specific antibody present 347.10 16.19 124 30163 3161 34923483
Malaise 329.86 16.19 582 29705 185243 34741401
Gait disturbance 329.86 16.19 387 29900 84753 34841891
Balance disorder 246.89 16.19 235 30052 40419 34886225
Cognitive disorder 242.38 16.19 200 30087 28493 34898151
Secondary progressive multiple sclerosis 240.39 16.19 58 30229 335 34926309
Magnetic resonance imaging abnormal 239.20 16.19 79 30208 1577 34925067
Fall 238.40 16.19 535 29752 202350 34724294
Memory impairment 232.43 16.19 234 30053 43084 34883560
Muscle spasticity 226.96 16.19 108 30179 5780 34920864
JC polyomavirus test positive 202.86 16.19 57 30230 640 34926004
Muscular weakness 202.40 16.19 281 30006 72616 34854028
Mobility decreased 197.94 16.19 182 30105 29946 34896698
Loss of control of legs 160.28 16.19 48 30239 685 34925959
Drug interaction 159.62 16.19 9 30278 225937 34700707
Gait inability 157.36 16.19 136 30151 20622 34906022
Off label use 154.80 16.19 86 30201 419438 34507206
Central nervous system lesion 154.63 16.19 86 30201 6377 34920267
Seizure 147.55 16.19 298 29989 104559 34822085
Poor venous access 143.56 16.19 76 30211 5107 34921537
Herpes zoster 138.97 16.19 160 30127 34239 34892405
Neoplasm malignant 134.11 16.19 122 30165 19783 34906861
Decubitus ulcer 131.45 16.19 87 30200 8834 34917810
Urosepsis 126.76 16.19 98 30189 12701 34913943
Hypersensitivity 126.03 16.19 205 30082 60830 34865814
Asthenia 116.70 16.19 470 29817 244781 34681863
Surgery 115.97 16.19 97 30190 14060 34912584
Acute kidney injury 113.04 16.19 62 30225 304926 34621718
Toxicity to various agents 112.96 16.19 19 30268 200343 34726301
Musculoskeletal disorder 112.55 16.19 69 30218 6135 34920509
Cystitis 108.28 16.19 80 30207 9685 34916959
Febrile neutropenia 104.76 16.19 3 30284 136846 34789798
Influenza 104.11 16.19 168 30119 49498 34877146
Neutropenia 102.67 16.19 9 30278 156769 34769875
Road traffic accident 102.27 16.19 99 30188 17351 34909293
Multiple sclerosis 95.95 16.19 64 30223 6581 34920063
Diarrhoea 94.41 16.19 120 30167 389792 34536852
Hypoaesthesia 92.78 16.19 180 30107 61264 34865380
Progressive multiple sclerosis 92.31 16.19 25 30262 242 34926402
Neurogenic bladder 91.09 16.19 40 30247 1773 34924871
Drug delivery device placement 88.43 16.19 21 30266 112 34926532
Anaemia 82.70 16.19 50 30237 233285 34693359
Primary progressive multiple sclerosis 79.62 16.19 16 30271 31 34926613
Nasopharyngitis 78.95 16.19 182 30105 69786 34856858
Product use in unapproved indication 71.11 16.19 9 30278 117490 34809154
Visual impairment 70.80 16.19 118 30169 35684 34890960
Coordination abnormal 70.21 16.19 56 30231 7588 34919056
Renal impairment 69.07 16.19 3 30284 94510 34832134
Lower limb fracture 67.51 16.19 43 30244 4088 34922556
Decreased appetite 67.29 16.19 30 30257 166362 34760282
Blood creatinine increased 66.29 16.19 4 30283 94972 34831672
Optic neuritis 65.46 16.19 40 30247 3534 34923110
Dyspnoea 64.32 16.19 145 30142 376637 34550007
Condition aggravated 64.21 16.19 44 30243 192152 34734492
Infection 63.51 16.19 198 30089 90717 34835927
Neuromyelitis optica spectrum disorder 62.70 16.19 16 30271 120 34926524
Drug ineffective 61.50 16.19 634 29653 456117 34470527
Depression 60.18 16.19 203 30084 96895 34829749
Thrombocytopenia 55.97 16.19 33 30254 156214 34770430
Cellulitis 54.57 16.19 133 30154 52818 34873826
Pancytopenia 53.60 16.19 9 30278 95148 34831496
Hyponatraemia 53.41 16.19 5 30282 82686 34843958
Haemoglobin decreased 51.66 16.19 20 30267 120752 34805892
Death 50.87 16.19 547 29740 397502 34529142
Urinary tract infection pseudomonal 50.01 16.19 22 30265 979 34925665
Disease progression 49.47 16.19 16 30271 108061 34818583
Hypotension 48.67 16.19 73 30214 221576 34705068
Drug abuse 48.41 16.19 13 30274 99083 34827561
Nausea 47.13 16.19 145 30142 339763 34586881
Agraphia 45.29 16.19 9 30278 16 34926628
Nephrolithiasis 44.69 16.19 88 30199 30245 34896399
Trigeminal neuralgia 42.69 16.19 21 30266 1208 34925436
Infusion site extravasation 42.42 16.19 33 30254 4311 34922333
Hip fracture 42.39 16.19 52 30235 11873 34914771
Nutritional supplementation 42.37 16.19 7 30280 0 34926644
Somnolence 41.89 16.19 22 30265 111094 34815550
Platelet count decreased 41.85 16.19 26 30261 119691 34806953
Rhabdomyolysis 41.76 16.19 5 30282 68158 34858486
Cardiac failure 40.89 16.19 14 30273 91234 34835410
Hyperkalaemia 40.34 16.19 6 30281 69383 34857261
JC virus granule cell neuronopathy 39.87 16.19 7 30280 3 34926641
Muscle spasms 39.75 16.19 149 30138 74852 34851792
Intervertebral disc protrusion 39.65 16.19 46 30241 9910 34916734
Gastrointestinal haemorrhage 38.92 16.19 14 30273 88463 34838181
Abdominal pain 38.76 16.19 51 30236 163567 34763077
Weight increased 37.21 16.19 17 30270 93016 34833628
Neutralising antibodies positive 37.19 16.19 10 30277 94 34926550
Influenza like illness 36.94 16.19 77 30210 27557 34899087
Foetal exposure timing unspecified 36.93 16.19 12 30275 227 34926417
Herpes zoster necrotising retinopathy 36.31 16.19 6 30281 0 34926644
Marburg's variant multiple sclerosis 36.31 16.19 6 30281 0 34926644
White blood cell count decreased 35.82 16.19 19 30268 95426 34831218
Epistaxis 33.94 16.19 5 30282 58246 34868398
Malignant melanoma 33.26 16.19 38 30249 8052 34918592
Mental disorder 32.59 16.19 52 30235 15157 34911487
Motor dysfunction 32.54 16.19 35 30252 6939 34919705
Staphylococcal infection 31.33 16.19 80 30207 32680 34893964
Epilepsy 31.22 16.19 62 30225 21433 34905211
Pleural effusion 30.94 16.19 16 30271 81530 34845114
No adverse event 30.77 16.19 64 30223 22863 34903781
Neutrophil count decreased 30.69 16.19 4 30283 51100 34875544
Renal failure 30.59 16.19 41 30246 130516 34796128
Chronic lymphocytic leukaemia 30.58 16.19 27 30260 4205 34922439
Escherichia urinary tract infection 30.49 16.19 25 30262 3521 34923123
Pneumonia aspiration 29.90 16.19 92 30195 41811 34884833
Tumefactive multiple sclerosis 29.69 16.19 7 30280 36 34926608
Peroneal nerve palsy 29.68 16.19 23 30264 2988 34923656
Product use issue 29.55 16.19 9 30278 63207 34863437
Adverse reaction 29.54 16.19 23 30264 3008 34923636
Leukopenia 29.29 16.19 9 30278 62847 34863797
Neuropathy peripheral 29.20 16.19 18 30269 83245 34843399
International normalised ratio increased 27.72 16.19 4 30283 47323 34879321
Bipolar disorder 27.70 16.19 24 30263 3645 34922999
Multiple organ dysfunction syndrome 27.63 16.19 16 30271 76550 34850094
Drug hypersensitivity 27.43 16.19 18 30269 80511 34846133
Metabolic acidosis 27.26 16.19 3 30284 43677 34882967
Hemiparesis 27.24 16.19 49 30238 15729 34910915
Ascites 27.13 16.19 4 30283 46567 34880077
Stem cell transplant 27.08 16.19 19 30268 2120 34924524
Speech disorder 26.95 16.19 65 30222 25621 34901023
Infected skin ulcer 26.88 16.19 17 30270 1596 34925048
C-reactive protein increased 26.59 16.19 7 30280 54091 34872553
Cardiac failure congestive 26.53 16.19 20 30267 83250 34843394
Decreased immune responsiveness 26.39 16.19 17 30270 1647 34924997
Testis cancer 26.19 16.19 16 30271 1413 34925231
Meningitis herpes 25.89 16.19 5 30282 7 34926637
Urinary incontinence 25.70 16.19 53 30234 18821 34907823
Relapsing-remitting multiple sclerosis 25.18 16.19 14 30273 1036 34925608
Antibody test positive 25.14 16.19 12 30275 646 34925998
Glioblastoma 25.07 16.19 14 30273 1045 34925599
Haematochezia 24.90 16.19 5 30282 46529 34880115
CD8 lymphocytes decreased 24.87 16.19 7 30280 79 34926565
HIV test positive 24.49 16.19 8 30279 154 34926490
Paraparesis 24.43 16.19 17 30270 1872 34924772
Appendicitis perforated 24.28 16.19 17 30270 1891 34924753
Intentional product misuse 24.20 16.19 5 30282 45606 34881038
Upper respiratory tract infection 23.97 16.19 73 30214 32986 34893658
Hemianaesthesia 23.63 16.19 7 30280 96 34926548
Tremor 23.61 16.19 137 30150 82450 34844194
Amnesia 23.48 16.19 63 30224 26500 34900144
Hypoglycaemia 23.42 16.19 9 30278 54631 34872013
Vision blurred 23.25 16.19 90 30197 45873 34880771
Chronic kidney disease 22.97 16.19 4 30283 41206 34885438
Prostate cancer 22.87 16.19 81 30206 39568 34887076
Central nervous system lymphoma 22.74 16.19 13 30274 1015 34925629
Intentional overdose 22.74 16.19 5 30282 43669 34882975
Peripheral swelling 22.38 16.19 20 30267 76521 34850123
Aphasia 22.20 16.19 54 30233 21400 34905244
Mental impairment 21.71 16.19 35 30252 10287 34916357
Dysgraphia 21.53 16.19 17 30270 2270 34924374
Plasma cell myeloma 21.51 16.19 5 30282 42032 34884612
Ophthalmic herpes zoster 21.49 16.19 12 30275 896 34925748
Gallbladder operation 21.34 16.19 10 30277 516 34926128
Intervertebral disc operation 20.91 16.19 8 30279 248 34926396
Sinusitis 20.88 16.19 81 30206 41321 34885323
Cardio-respiratory arrest 20.73 16.19 11 30276 55262 34871382
Agitation 20.69 16.19 12 30275 57387 34869257
Small for dates baby 20.63 16.19 21 30266 3906 34922738
Bladder catheterisation 20.56 16.19 10 30277 561 34926083
Uhthoff's phenomenon 20.55 16.19 4 30283 6 34926638
Tachycardia 20.48 16.19 26 30261 84746 34841898
Oedema peripheral 20.42 16.19 46 30241 119766 34806878
Headache 20.28 16.19 264 30023 200371 34726273
Lactic acidosis 20.22 16.19 3 30284 34769 34891875
Abdominal distension 20.01 16.19 13 30274 58479 34868165
Stomatitis 19.96 16.19 6 30281 42508 34884136
Dysstasia 19.95 16.19 37 30250 12158 34914486
Kidney infection 19.95 16.19 24 30263 5370 34921274
Constipation 19.94 16.19 57 30230 136925 34789719
Bladder disorder 19.83 16.19 19 30268 3285 34923359
Bradycardia 19.43 16.19 22 30265 75396 34851248
Osteomyelitis 19.31 16.19 43 30244 16093 34910551
Temperature intolerance 19.26 16.19 19 30268 3403 34923241
Hypoxia 19.19 16.19 12 30275 55083 34871561
Therapeutic product effect incomplete 19.04 16.19 10 30277 50531 34876113
Overdose 18.97 16.19 31 30256 91028 34835616
Ataxia 18.97 16.19 39 30248 13814 34912830
B-cell lymphoma 18.80 16.19 21 30266 4342 34922302
Herpes simplex encephalitis 18.71 16.19 8 30279 332 34926312
CD4 lymphocytes decreased 18.70 16.19 14 30273 1727 34924917
Vomiting 18.54 16.19 132 30155 247489 34679155
Arthropod bite 18.48 16.19 17 30270 2792 34923852
Joint swelling 18.30 16.19 15 30272 59875 34866769
Urticaria 18.16 16.19 104 30183 62273 34864371
Drug rehabilitation 18.16 16.19 3 30284 0 34926644
Wernicke-Korsakoff syndrome 18.16 16.19 3 30284 0 34926644
JC polyomavirus test 18.16 16.19 3 30284 0 34926644
Laryngeal cancer stage 0 18.16 16.19 3 30284 0 34926644
Spinal operation 17.80 16.19 17 30270 2927 34923717
Basal cell carcinoma 17.76 16.19 47 30240 19611 34907033
Urinary tract disorder 17.71 16.19 15 30272 2209 34924435
Ill-defined disorder 17.70 16.19 38 30249 13871 34912773
Dry skin 17.51 16.19 3 30284 31284 34895360
Lyme disease 17.47 16.19 11 30276 1024 34925620
Back disorder 17.46 16.19 25 30262 6626 34920018
Thrombocytopenia neonatal 17.44 16.19 8 30279 393 34926251
Pneumonitis 17.39 16.19 4 30283 33874 34892770
Migraine 17.03 16.19 43 30244 17435 34909209
Head injury 17.00 16.19 44 30243 18116 34908528
Rheumatoid arthritis 16.89 16.19 6 30281 38232 34888412
Lumbar radiculopathy 16.89 16.19 10 30277 834 34925810
Blindness 16.89 16.19 39 30248 14947 34911697
Focal dyscognitive seizures 16.86 16.19 12 30275 1369 34925275
Blood creatine phosphokinase increased 16.71 16.19 9 30278 44848 34881796
Rectal haemorrhage 16.64 16.19 7 30280 40242 34886402
Concussion 16.55 16.19 15 30272 2418 34924226
Foetal exposure during pregnancy 16.41 16.19 71 30216 38030 34888614
Brain malformation 16.39 16.19 6 30281 164 34926480

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 13130.97 12.93 3995 93427 42538 79604428
Progressive multifocal leukoencephalopathy 5094.06 12.93 1603 95819 18997 79627969
Immune reconstitution inflammatory syndrome 3229.05 12.93 1031 96391 12810 79634156
Urinary tract infection 1973.58 12.93 2029 95393 272483 79374483
General symptom 1432.45 12.93 376 97046 2158 79644808
Abortion spontaneous 1055.01 12.93 575 96847 28932 79618034
Drug specific antibody present 994.57 12.93 355 97067 6297 79640669
Prescribed underdose 929.15 12.93 529 96893 28985 79617981
Malaise 773.64 12.93 1787 95635 488082 79158884
Fall 742.78 12.93 1754 95668 485875 79161091
Poor venous access 616.40 12.93 342 97080 17807 79629159
Balance disorder 602.01 12.93 671 96751 98186 79548780
Gait disturbance 561.03 12.93 950 96472 206556 79440410
Seizure 522.98 12.93 874 96548 187960 79459006
Off label use 520.64 12.93 230 97192 906985 78739981
Magnetic resonance imaging abnormal 495.95 12.93 179 97243 3280 79643686
Maternal exposure during pregnancy 455.07 12.93 688 96734 135850 79511116
Secondary progressive multiple sclerosis 443.76 12.93 132 97290 1265 79645701
Central nervous system lesion 443.25 12.93 248 97174 13120 79633846
Herpes zoster 405.00 12.93 533 96889 92550 79554416
Loss of control of legs 399.42 12.93 132 97290 1833 79645133
Memory impairment 375.02 12.93 565 96857 111169 79535797
Muscle spasticity 372.06 12.93 264 97158 21211 79625755
Drug interaction 371.88 12.93 38 97384 415145 79231821
Toxicity to various agents 371.39 12.93 41 97381 421499 79225467
Breast cancer 356.74 12.93 310 97112 33471 79613495
Muscular weakness 338.80 12.93 661 96761 160068 79486898
Cognitive disorder 315.91 12.93 408 97014 69518 79577448
Caesarean section 298.91 12.93 188 97234 12347 79634619
JC polyomavirus test positive 291.45 12.93 99 97323 1503 79645463
Optic neuritis 289.71 12.93 167 97255 9353 79637613
Invasive ductal breast carcinoma 288.74 12.93 142 97280 5750 79641216
Decubitus ulcer 288.38 12.93 200 97222 15487 79631479
Hypersensitivity 275.15 12.93 823 96599 261416 79385550
Acute kidney injury 270.87 12.93 149 97273 519255 79127711
Diarrhoea 261.97 12.93 421 97001 880068 78766898
Drug delivery device placement 256.14 12.93 58 97364 154 79646812
Febrile neutropenia 253.49 12.93 6 97416 230993 79415973
Condition aggravated 242.63 12.93 157 97265 500967 79145999
Influenza 240.84 12.93 506 96916 129100 79517866
Neutropenia 233.97 12.93 36 97386 287674 79359292
Nasopharyngitis 232.34 12.93 760 96662 253121 79393845
Cystitis 229.30 12.93 302 97120 52430 79594536
Hypoaesthesia 228.33 12.93 604 96818 178748 79468218
Product use in unapproved indication 208.93 12.93 29 97393 250330 79396636
Musculoskeletal disorder 208.81 12.93 188 97234 21260 79625706
Urosepsis 207.77 12.93 206 97216 26289 79620677
Trigeminal neuralgia 204.20 12.93 96 97326 3513 79643453
Asthenia 196.40 12.93 1180 96242 510509 79136457
Gait inability 196.20 12.93 297 97125 58620 79588346
Surgery 188.29 12.93 216 97206 32550 79614416
Opportunistic infection 187.29 12.93 85 97337 2865 79644101
Neurogenic bladder 187.18 12.93 95 97327 4117 79642849
Road traffic accident 180.51 12.93 244 97178 43420 79603546
Product use issue 175.77 12.93 24 97398 209798 79437168
Neutralising antibodies positive 173.21 12.93 45 97377 246 79646720
Hysterectomy 172.35 12.93 103 97319 6169 79640797
Visual impairment 170.27 12.93 359 97063 91772 79555194
Joint swelling 169.86 12.93 70 97352 288576 79358390
Mobility decreased 163.12 12.93 419 97003 121756 79525210
Rheumatoid arthritis 162.94 12.93 29 97393 208441 79438525
Neuromyelitis optica spectrum disorder 160.99 12.93 57 97365 985 79645981
Decreased appetite 160.54 12.93 111 97311 342307 79304659
Contraindicated product administered 153.06 12.93 10 97412 157528 79489438
Progressive multiple sclerosis 152.35 12.93 57 97365 1160 79645806
Drug hypersensitivity 148.12 12.93 91 97331 298825 79348141
Hip fracture 147.56 12.93 185 97237 30576 79616390
Malignant melanoma 145.04 12.93 130 97292 14611 79632355
Ankle fracture 144.40 12.93 138 97284 16831 79630135
Multiple sclerosis 143.66 12.93 156 97266 22126 79624840
Decreased immune responsiveness 140.36 12.93 86 97336 5389 79641577
Peripheral swelling 137.91 12.93 79 97343 269538 79377428
Epilepsy 134.63 12.93 205 97217 40655 79606311
Dyspnoea 132.83 12.93 568 96854 856457 78790509
Intervertebral disc protrusion 131.15 12.93 153 97269 23468 79623498
Hemiparesis 131.13 12.93 183 97239 33550 79613416
Drug abuse 130.72 12.93 21 97401 162670 79484296
Drug intolerance 130.01 12.93 81 97341 264038 79382928
Thrombocytopenia 129.68 12.93 82 97340 265177 79381789
Cervical dysplasia 126.95 12.93 59 97363 2102 79644864
Depression 126.88 12.93 563 96859 216227 79430739
Pancytopenia 125.35 12.93 25 97397 165720 79481246
Renal impairment 123.16 12.93 22 97400 157761 79489205
Hyponatraemia 122.25 12.93 33 97389 177815 79469151
Peroneal nerve palsy 120.44 12.93 81 97341 5961 79641005
Blood creatinine increased 120.21 12.93 22 97400 155035 79491931
Lower limb fracture 120.03 12.93 145 97277 23070 79623896
Hyperkalaemia 118.20 12.93 5 97417 114393 79532573
Disease progression 118.02 12.93 39 97383 184323 79462643
Injection site pain 115.75 12.93 12 97410 129826 79517140
Intraductal proliferative breast lesion 113.08 12.93 57 97365 2434 79644532
Stress 112.45 12.93 279 97143 79333 79567633
Weight increased 112.31 12.93 104 97318 277282 79369684
Glossodynia 108.51 12.93 4 97418 103333 79543633
Nephrolithiasis 108.27 12.93 216 97206 53075 79593891
Therapeutic product effect incomplete 107.87 12.93 21 97401 141624 79505342
Pemphigus 107.62 12.93 3 97419 99579 79547387
Bronchitis 103.47 12.93 373 97049 130271 79516695
Stomatitis 103.21 12.93 26 97396 146731 79500235
Coordination abnormal 102.62 12.93 116 97306 17196 79629770
Platelet count decreased 102.46 12.93 55 97367 194609 79452357
Vein disorder 102.17 12.93 69 97353 5113 79641853
Uterine leiomyoma 101.97 12.93 75 97347 6368 79640598
Anaemia 101.46 12.93 248 97174 444767 79202199
Pregnancy 100.41 12.93 143 97279 26708 79620258
Haemoglobin decreased 98.83 12.93 76 97346 222043 79424923
C-reactive protein increased 98.53 12.93 19 97403 129008 79517958
Abdominal pain 97.80 12.93 206 97216 389363 79257603
Herpes zoster necrotising retinopathy 97.05 12.93 17 97405 0 79646966
Arthralgia 95.26 12.93 368 97054 571435 79075531
Cardiac failure 95.23 12.93 35 97387 154807 79492159
Muscle spasms 94.90 12.93 444 96978 174286 79472680
Upper respiratory tract infection 92.43 12.93 283 97139 90885 79556081
Electrocardiogram QT prolonged 90.01 12.93 5 97417 90381 79556585
Breech presentation 88.32 12.93 33 97389 669 79646297
Abdominal discomfort 88.03 12.93 106 97316 250621 79396345
Mental impairment 87.35 12.93 112 97310 18924 79628042
Staphylococcal infection 87.32 12.93 209 97213 58086 79588880
Prolonged labour 85.44 12.93 29 97393 439 79646527
Aphasia 85.02 12.93 181 97241 46551 79600415
Intentional product use issue 84.50 12.93 40 97382 152072 79494894
Hypotension 84.28 12.93 267 97155 440050 79206916
JC virus granule cell neuronopathy 84.26 12.93 22 97400 123 79646843
Escherichia urinary tract infection 82.57 12.93 93 97329 13732 79633234
Intentional product misuse 81.79 12.93 10 97412 95155 79551811
Treatment failure 81.51 12.93 54 97368 170432 79476534
Multiple organ dysfunction syndrome 81.33 12.93 23 97399 120223 79526743
Hospitalisation 80.75 12.93 10 97412 94226 79552740
Intentional overdose 80.06 12.93 16 97406 105944 79541022
Urinary incontinence 79.74 12.93 163 97259 40746 79606220
Rhabdomyolysis 79.13 12.93 15 97407 103116 79543850
Kidney infection 78.23 12.93 114 97308 21737 79625229
Migraine 78.12 12.93 260 97162 87233 79559733
Anaphylactic shock 78.08 12.93 150 97272 35846 79611120
Gallbladder operation 76.98 12.93 41 97381 1964 79645002
Infusion site extravasation 76.30 12.93 77 97345 10031 79636935
Leukopenia 75.69 12.93 24 97398 116489 79530477
Relapsing-remitting multiple sclerosis 75.59 12.93 37 97385 1482 79645484
Loss of personal independence in daily activities 74.42 12.93 17 97405 102563 79544403
Nausea 73.91 12.93 781 96641 956415 78690551
Cellulitis 73.65 12.93 296 97126 108764 79538202
Urticaria 73.23 12.93 431 96991 184770 79462196
Injection site erythema 72.97 12.93 6 97416 78191 79568775
Head injury 72.96 12.93 149 97273 37220 79609746
Alopecia 72.84 12.93 106 97316 231249 79415717
Urinary tract infection pseudomonal 72.53 12.93 38 97384 1760 79645206
Pericarditis 72.26 12.93 19 97403 104217 79542749
Headache 71.90 12.93 1159 96263 652613 78994353
Speech disorder 71.86 12.93 186 97236 54259 79592707
Gastrointestinal haemorrhage 71.68 12.93 46 97376 147673 79499293
Neutrophil count decreased 71.38 12.93 14 97408 93945 79553021
Dyspnoea exertional 70.46 12.93 11 97411 87062 79559904
Central venous catheterisation 70.17 12.93 46 97376 3243 79643723
Interstitial lung disease 70.00 12.93 25 97397 112575 79534391
White blood cell count decreased 69.98 12.93 76 97346 188212 79458754
Focal dyscognitive seizures 69.81 12.93 47 97375 3465 79643501
Bladder disorder 69.52 12.93 70 97352 9095 79637871
Pleural effusion 69.45 12.93 46 97376 145216 79501750
Systemic lupus erythematosus 68.61 12.93 31 97391 121118 79525848
Post lumbar puncture syndrome 68.13 12.93 28 97394 737 79646229
Vision blurred 66.45 12.93 281 97141 105617 79541349
Diplopia 66.00 12.93 134 97288 33332 79613634
Gastric bypass 65.67 12.93 32 97390 1269 79645697
Wrong technique in product usage process 65.39 12.93 7 97415 73868 79573098
Meningitis herpes 65.33 12.93 20 97402 213 79646753
Neuropathy peripheral 64.56 12.93 47 97375 141258 79505708
Epistaxis 64.00 12.93 28 97394 111487 79535479
Central nervous system lymphoma 63.95 12.93 38 97384 2251 79644715
Atrial fibrillation 63.94 12.93 89 97333 197797 79449169
Mental disorder 63.72 12.93 127 97295 31175 79615791
Incorrect dose administered 63.58 12.93 9 97413 76621 79570345
Gastroenteritis viral 63.36 12.93 111 97311 24720 79622246
Drug reaction with eosinophilia and systemic symptoms 62.61 12.93 4 97418 64240 79582726
Chronic lymphocytic leukaemia 62.43 12.93 50 97372 4816 79642150
Ascites 62.40 12.93 9 97413 75553 79571413
Ectopic pregnancy 62.33 12.93 34 97388 1709 79645257
Papillary thyroid cancer 62.18 12.93 39 97383 2547 79644419
International normalised ratio increased 61.54 12.93 14 97408 84707 79562259
Appendicitis perforated 61.01 12.93 42 97380 3211 79643755
Cholecystectomy 60.73 12.93 66 97356 9366 79637600
Hypoxia 60.72 12.93 25 97397 103218 79543748
Helicobacter infection 60.70 12.93 7 97415 69697 79577269
Oxygen saturation decreased 60.17 12.93 42 97380 129005 79517961
Breast cancer in situ 59.24 12.93 27 97395 919 79646047
Metabolic acidosis 59.22 12.93 14 97408 82515 79564451
Lower respiratory tract infection 59.01 12.93 43 97379 129177 79517789
Lactic acidosis 58.99 12.93 8 97414 70351 79576615
Upper limb fracture 58.97 12.93 90 97332 17877 79629089
Sinusitis 58.94 12.93 425 96997 195076 79451890
Influenza like illness 58.68 12.93 207 97215 71500 79575466
Swelling 57.39 12.93 111 97311 216600 79430366
Pharyngitis streptococcal 57.15 12.93 68 97354 10646 79636320
Uhthoff's phenomenon 57.09 12.93 10 97412 0 79646966
Arthropathy 56.87 12.93 80 97342 177031 79469935
Cervix carcinoma 56.76 12.93 35 97387 2218 79644748
Thyroid cancer 56.40 12.93 50 97372 5538 79641428
Rash maculo-papular 56.15 12.93 3 97419 56075 79590891
Melaena 55.91 12.93 5 97417 60885 79586081
Renal failure 55.81 12.93 100 97322 200868 79446098
Blister 55.55 12.93 39 97383 119437 79527529
Primary progressive multiple sclerosis 55.46 12.93 15 97407 98 79646868
Bipolar disorder 55.07 12.93 57 97365 7650 79639316
Tremor 54.93 12.93 376 97046 169707 79477259
Therapy non-responder 54.86 12.93 22 97400 92283 79554683
Partial seizures 54.65 12.93 61 97361 8917 79638049
Somnolence 54.52 12.93 133 97289 238848 79408118
Hypoglycaemia 54.47 12.93 28 97394 101566 79545400
Foot fracture 54.46 12.93 97 97325 21884 79625082
Dyspepsia 53.89 12.93 33 97389 108654 79538312
Completed suicide 53.57 12.93 140 97282 245627 79401339
Breast cancer female 53.48 12.93 68 97354 11393 79635573
Dysgraphia 52.95 12.93 42 97380 3990 79642976
Therapeutic response decreased 52.85 12.93 9 97413 66844 79580122
Meningioma 52.68 12.93 43 97379 4255 79642711
Rash 52.08 12.93 454 96968 577904 79069062
Infection 51.62 12.93 486 96936 241226 79405740
Lymphocytosis 51.41 12.93 44 97378 4649 79642317
Cough 51.25 12.93 252 97170 366537 79280429
Adverse reaction 51.15 12.93 60 97362 9254 79637712
Cardio-respiratory arrest 51.00 12.93 35 97387 108475 79538491
Medication error 50.54 12.93 11 97411 68631 79578335
Invasive lobular breast carcinoma 49.97 12.93 22 97400 689 79646277
Endometriosis 49.87 12.93 39 97383 3629 79643337
White blood cell count increased 49.13 12.93 201 97221 74432 79572534
Adenocarcinoma of colon 48.92 12.93 46 97376 5495 79641471
Tachycardia 48.87 12.93 89 97333 177679 79469287
Lung adenocarcinoma 48.85 12.93 54 97368 7810 79639156
Foetal malposition 48.78 12.93 10 97412 13 79646953
Tibia fracture 48.29 12.93 45 97377 5316 79641650
Flushing 47.66 12.93 224 97198 88044 79558922
Fatigue 47.10 12.93 1476 95946 928251 78718715
Exposure during pregnancy 47.03 12.93 33 97389 101099 79545867
Blood pressure systolic increased 46.82 12.93 12 97410 66974 79579992
No adverse event 45.96 12.93 124 97298 37068 79609898
Temperature intolerance 45.95 12.93 58 97364 9647 79637319
Vomiting 45.84 12.93 557 96865 665271 78981695
Wheezing 45.70 12.93 45 97377 116619 79530347
Amnesia 45.68 12.93 175 97247 62882 79584084
Inappropriate schedule of product administration 45.29 12.93 58 97364 133570 79513396
Sensory disturbance 44.59 12.93 72 97350 15005 79631961
Rectal haemorrhage 44.02 12.93 19 97403 76281 79570685
Bradycardia 43.74 12.93 61 97361 135496 79511470
Abdominal distension 43.67 12.93 49 97373 119601 79527365
Cardiac failure congestive 43.10 12.93 67 97355 142335 79504631
Abortion missed 43.06 12.93 24 97398 1259 79645707
Blood creatine phosphokinase increased 42.23 12.93 14 97408 66076 79580890
Productive cough 42.17 12.93 28 97394 88303 79558663
Viral infection 42.16 12.93 132 97290 42884 79604082
Dysstasia 42.10 12.93 100 97322 27646 79619320
Injection site reaction 41.95 12.93 8 97414 54777 79592189
Ophthalmic herpes zoster 41.92 12.93 31 97391 2653 79644313
Basal cell carcinoma 41.64 12.93 120 97302 37255 79609711
Fibula fracture 41.38 12.93 35 97387 3639 79643327
Ovarian cancer 41.30 12.93 36 97386 3898 79643068
Agranulocytosis 40.54 12.93 4 97418 45026 79601940
Clostridial infection 40.36 12.93 42 97380 5672 79641294
Haematochezia 40.23 12.93 29 97393 87616 79559350
Marburg's variant multiple sclerosis 39.96 12.93 7 97415 0 79646966
Pneumonia aspiration 39.92 12.93 175 97247 66792 79580174
Herpes simplex encephalitis 39.87 12.93 19 97403 717 79646249
Pyelonephritis 39.45 12.93 81 97341 20307 79626659
Psoriasis 39.37 12.93 31 97391 89556 79557410
Inflammation 39.28 12.93 34 97388 93719 79553247
Concussion 39.10 12.93 53 97369 9450 79637516
Red blood cell sedimentation rate increased 39.05 12.93 5 97417 45937 79601029
Relapsing multiple sclerosis 39.01 12.93 12 97410 130 79646836
Generalised tonic-clonic seizure 38.75 12.93 130 97292 43780 79603186
Injection site bruising 38.66 12.93 3 97419 40999 79605967
Weight decreased 38.39 12.93 265 97157 354933 79292033
Oedema 38.39 12.93 54 97368 119526 79527440
Oedema peripheral 38.37 12.93 168 97254 252120 79394846
Bone marrow failure 38.01 12.93 8 97414 51099 79595867
Dry mouth 38.00 12.93 31 97391 87988 79558978
Haemoptysis 37.33 12.93 11 97411 55988 79590978
JC polyomavirus test 36.74 12.93 9 97413 37 79646929
Antibody test positive 36.48 12.93 29 97393 2763 79644203
Constipation 36.40 12.93 200 97222 282850 79364116
Dry skin 36.06 12.93 19 97403 67976 79578990
Post procedural infection 35.92 12.93 56 97366 11328 79635638
Serotonin syndrome 35.73 12.93 6 97416 45021 79601945
General physical health deterioration 35.66 12.93 194 97228 275044 79371922
Blood urea increased 35.55 12.93 8 97414 48782 79598184
Myalgia 35.14 12.93 113 97309 185528 79461438
Unevaluable event 35.12 12.93 12 97410 55573 79591393
Folliculitis 34.92 12.93 12 97410 55368 79591598
Agraphia 34.83 12.93 9 97413 48 79646918
Appendicectomy 34.75 12.93 28 97394 2720 79644246
Skin exfoliation 34.64 12.93 12 97410 55088 79591878
Drug level increased 34.48 12.93 4 97418 39647 79607319
Drug ineffective for unapproved indication 34.27 12.93 10 97412 51228 79595738
Hemianaesthesia 34.21 12.93 15 97407 465 79646501
Fibromyalgia 34.09 12.93 18 97404 64322 79582644
Delirium 33.89 12.93 32 97390 84595 79562371
Pneumonitis 33.79 12.93 16 97406 60844 79586122
Ataxia 33.50 12.93 86 97336 24953 79622013
Meningitis viral 33.41 12.93 24 97398 1964 79645002
Pruritus allergic 33.39 12.93 21 97401 1378 79645588
Urostomy 33.36 12.93 7 97415 11 79646955
Female genital operation 32.99 12.93 7 97415 12 79646954
Hypocalcaemia 32.92 12.93 10 97412 49914 79597052
Chronic kidney disease 32.91 12.93 20 97402 66134 79580832
Overdose 32.90 12.93 115 97307 184091 79462875
Tubulointerstitial nephritis 32.89 12.93 4 97418 38231 79608735
Hypertension 32.84 12.93 253 97169 330739 79316227
Band sensation 32.78 12.93 17 97405 771 79646195
Motor dysfunction 32.69 12.93 62 97360 14671 79632295
Paraparesis 32.49 12.93 31 97391 3772 79643194
Ventricular tachycardia 32.37 12.93 6 97416 41929 79605037
Agitation 32.04 12.93 45 97377 99670 79547296
Incorrect route of product administration 31.72 12.93 3 97419 34926 79612040
Osteonecrosis of jaw 31.67 12.93 7 97415 43219 79603747
Cholestasis 31.65 12.93 12 97410 52097 79594869
Hypokalaemia 31.40 12.93 82 97340 143958 79503008
Plasma cell myeloma 31.14 12.93 13 97409 53246 79593720
Meningoencephalitis herpetic 31.13 12.93 23 97399 1966 79645000
Hypervolaemia 31.11 12.93 7 97415 42683 79604283
Hyperhidrosis 30.96 12.93 89 97333 151403 79495563
Vaginal infection 30.84 12.93 37 97385 5843 79641123
B-cell lymphoma 30.79 12.93 38 97384 6177 79640789
Incontinence 30.68 12.93 59 97363 14105 79632861
Drug resistance 30.60 12.93 7 97415 42206 79604760
Adverse drug reaction 30.52 12.93 161 97261 66231 79580735
Immune system disorder 30.37 12.93 51 97371 10978 79635988
Cardiac arrest 30.36 12.93 108 97314 171988 79474978
Conversion disorder 30.21 12.93 22 97400 1839 79645127
Prescribed overdose 30.16 12.93 5 97417 37878 79609088
Arthropod bite 30.04 12.93 44 97378 8427 79638539
Haematuria 30.02 12.93 24 97398 68812 79578154
Hypomagnesaemia 29.86 12.93 10 97412 46901 79600065
Sedation 29.81 12.93 13 97409 51882 79595084
Liver injury 29.76 12.93 16 97406 56598 79590368
Sopor 29.54 12.93 3 97419 33007 79613959
Major depression 29.49 12.93 45 97377 8935 79638031
Vertigo 29.38 12.93 164 97258 68918 79578048
Arrested labour 29.36 12.93 10 97412 153 79646813
Tumefactive multiple sclerosis 29.14 12.93 9 97413 99 79646867
Malignant melanoma in situ 28.94 12.93 24 97398 2428 79644538
Hepatic function abnormal 28.85 12.93 28 97394 73079 79573887
Disease recurrence 28.79 12.93 9 97413 44100 79602866
Depressed level of consciousness 28.74 12.93 46 97376 96606 79550360
Blood cholesterol increased 28.71 12.93 36 97386 83684 79563282
Neutralising antibodies 28.53 12.93 7 97415 29 79646937
Bladder dysfunction 28.44 12.93 18 97404 1194 79645772
Nasal congestion 28.31 12.93 31 97391 76521 79570445
Sleep disorder 28.19 12.93 38 97384 85639 79561327
Glioblastoma 27.80 12.93 20 97402 1640 79645326
Obstructive airways disorder 27.79 12.93 3 97419 31456 79615510
Restlessness 27.75 12.93 11 97411 46481 79600485
Urinary tract infection staphylococcal 27.70 12.93 16 97406 899 79646067
Infected skin ulcer 27.69 12.93 27 97395 3374 79643592
Therapy interrupted 27.66 12.93 3 97419 31338 79615628
Bladder catheterisation 27.55 12.93 16 97406 908 79646058
Myelitis 27.39 12.93 23 97399 2368 79644598
Urinary tract disorder 27.32 12.93 28 97394 3714 79643252
Hepatocellular injury 27.22 12.93 12 97410 47581 79599385
Partial seizures with secondary generalisation 27.15 12.93 14 97408 627 79646339
Treatment noncompliance 27.14 12.93 15 97407 52253 79594713
Myelitis transverse 27.12 12.93 21 97401 1926 79645040
Animal bite 27.09 12.93 24 97398 2655 79644311
Anal incontinence 27.05 12.93 65 97357 18103 79628863
Depression suicidal 26.70 12.93 28 97394 3814 79643152
Mammoplasty 26.58 12.93 11 97411 295 79646671
Neurogenic bowel 26.57 12.93 10 97412 207 79646759
Hyperglycaemia 26.55 12.93 28 97394 70307 79576659
Proteinuria 26.53 12.93 4 97418 32498 79614468
Shock 26.50 12.93 10 97412 43538 79603428
Coagulopathy 26.04 12.93 6 97416 36000 79610966
Circulatory collapse 25.84 12.93 7 97415 37661 79609305
Muscle tightness 25.80 12.93 52 97370 12862 79634104
Status epilepticus 25.61 12.93 78 97344 24963 79622003
Irritable bowel syndrome 25.55 12.93 23 97399 62218 79584748
Discomfort 25.52 12.93 74 97348 125543 79521423
Umbilical cord around neck 25.25 12.93 6 97416 21 79646945
Orthostatic hypotension 25.23 12.93 19 97403 56145 79590821
Paraesthesia 24.97 12.93 327 97095 175996 79470970
Papilloma viral infection 24.80 12.93 19 97403 1715 79645251
Foetal heart rate deceleration abnormality 24.76 12.93 8 97414 103 79646863
Death 24.63 12.93 884 96538 565630 79081336
Intrathecal pump insertion 24.61 12.93 5 97417 6 79646960
Gastrooesophageal reflux disease 24.56 12.93 57 97365 104189 79542777
Postoperative wound infection 24.49 12.93 51 97371 12910 79634056
Pneumocystis jirovecii pneumonia 24.36 12.93 5 97417 32503 79614463
Feeling hot 24.21 12.93 140 97282 59594 79587372
Infectious mononucleosis 24.13 12.93 20 97402 2022 79644944
Medical device change 24.08 12.93 12 97410 500 79646466
Flatulence 24.08 12.93 11 97411 42713 79604253
Calculus bladder 24.06 12.93 17 97405 1355 79645611
Blood pressure diastolic decreased 24.03 12.93 4 97418 30212 79616754
Disseminated intravascular coagulation 23.96 12.93 7 97415 35835 79611131
Blood pressure fluctuation 23.95 12.93 28 97394 67117 79579849
Tachypnoea 23.88 12.93 5 97417 32058 79614908
Pulmonary fibrosis 23.88 12.93 12 97410 44100 79602866
Thermal burn 23.68 12.93 36 97386 7124 79639842
Steroid therapy 23.46 12.93 8 97414 123 79646843
Medical device removal 23.32 12.93 13 97409 682 79646284
Catheter placement 23.08 12.93 23 97399 2951 79644015
Colon cancer metastatic 22.98 12.93 20 97402 2161 79644805
Goitre 22.95 12.93 31 97391 5508 79641458
Bile acid malabsorption 22.91 12.93 9 97413 210 79646756
Colon cancer 22.75 12.93 53 97369 14470 79632496
Adenosquamous cell lung cancer stage IV 22.74 12.93 5 97417 11 79646955
Ejection fraction decreased 22.67 12.93 7 97415 34570 79612396
Blood pressure increased 22.66 12.93 158 97264 211202 79435764
Breast cancer stage I 22.61 12.93 34 97388 6666 79640300
H1N1 influenza 22.41 12.93 21 97401 2498 79644468
Progressive relapsing multiple sclerosis 22.35 12.93 6 97416 38 79646928
Post procedural complication 22.32 12.93 72 97350 23757 79623209
Ligament rupture 22.29 12.93 24 97398 3370 79643596
Cephalo-pelvic disproportion 22.19 12.93 8 97414 146 79646820
Pneumonia 22.16 12.93 1002 96420 659244 78987722
Haemorrhage 22.13 12.93 49 97373 91069 79555897
Osteomyelitis 22.01 12.93 89 97333 32776 79614190
Pelvic fracture 21.88 12.93 47 97375 12157 79634809
Autoimmune hepatitis 21.84 12.93 46 97376 11737 79635229
Haematemesis 21.83 12.93 19 97403 52245 79594721
Ovarian mass 21.79 12.93 11 97411 471 79646495
Ventricular fibrillation 21.78 12.93 6 97416 31920 79615046
Fibroadenoma of breast 21.73 12.93 10 97412 348 79646618
Cervix carcinoma stage III 21.71 12.93 6 97416 43 79646923
Cellulitis staphylococcal 21.66 12.93 15 97407 1158 79645808
Cervical spinal stenosis 21.63 12.93 20 97402 2339 79644627
Foetal distress syndrome 21.58 12.93 11 97411 481 79646485
Dysarthria 21.51 12.93 149 97273 67473 79579493
Hypercalcaemia 21.49 12.93 10 97412 38420 79608546
Pineal gland cyst 21.39 12.93 5 97417 16 79646950
Palpitations 21.31 12.93 81 97341 126529 79520437
Upper gastrointestinal haemorrhage 21.30 12.93 12 97410 41368 79605598
Respiratory depression 21.23 12.93 4 97418 27626 79619340
Frequent bowel movements 21.21 12.93 5 97417 29534 79617432
Therapeutic procedure 21.12 12.93 13 97409 821 79646145
Frustration tolerance decreased 21.07 12.93 35 97387 7467 79639499
Fluid retention 20.97 12.93 33 97389 69776 79577190
Blood potassium increased 20.93 12.93 5 97417 29270 79617696
Poisoning 20.88 12.93 3 97419 25269 79621697
Plasmablastic lymphoma 20.87 12.93 11 97411 516 79646450
Faeces discoloured 20.78 12.93 5 97417 29122 79617844
Rebound effect 20.68 12.93 34 97388 7192 79639774
Pulmonary hypertension 20.67 12.93 17 97405 48063 79598903
Lung adenocarcinoma stage IV 20.62 12.93 9 97413 276 79646690
Human papilloma virus test positive 20.61 12.93 11 97411 529 79646437
B-cell lymphoma stage I 20.60 12.93 4 97418 3 79646963
Infusion site haematoma 20.50 12.93 9 97413 280 79646686
Red blood cell count decreased 20.49 12.93 24 97398 57489 79589477
Endometrial adenocarcinoma 20.45 12.93 14 97408 1061 79645905
Cholelithiasis 20.42 12.93 122 97300 52542 79594424
Bladder repair 20.41 12.93 6 97416 55 79646911
Wound sepsis 20.35 12.93 8 97414 187 79646779
Herpes simplex meningitis 20.31 12.93 6 97416 56 79646910
Knee operation 20.12 12.93 30 97392 5836 79641130
Feeling abnormal 19.99 12.93 289 97133 158910 79488056
Quadriparesis 19.97 12.93 23 97399 3478 79643488
Red blood cell nucleated morphology present 19.96 12.93 5 97417 23 79646943
Osteonecrosis 19.87 12.93 83 97339 31012 79615954
Oral pain 19.86 12.93 7 97415 31791 79615175
Hyperemesis gravidarum 19.82 12.93 10 97412 428 79646538
CD4 lymphocytes decreased 19.76 12.93 20 97402 2614 79644352
Septic shock 19.75 12.93 80 97342 122721 79524245
JC virus infection 19.67 12.93 24 97398 3857 79643109
Appendicitis 19.63 12.93 63 97359 20731 79626235
Ependymoma 19.34 12.93 6 97416 67 79646899
Asthma 19.30 12.93 92 97330 135003 79511963
Spondylitic myelopathy 19.10 12.93 6 97416 70 79646896
Latent tuberculosis 19.08 12.93 22 97400 3331 79643635
Angina pectoris 19.07 12.93 21 97401 51711 79595255
Blindness unilateral 18.97 12.93 35 97387 8111 79638855
Therapeutic product effect decreased 18.81 12.93 120 97302 163743 79483223
Mammogram abnormal 18.78 12.93 10 97412 479 79646487
Glioblastoma multiforme 18.77 12.93 14 97408 1214 79645752
Hepatotoxicity 18.76 12.93 21 97401 51331 79595635
Tooth infection 18.64 12.93 58 97364 18774 79628192
Expanded disability status scale score increased 18.54 12.93 11 97411 650 79646316
Dysphemia 18.40 12.93 22 97400 3462 79643504
Leukocytosis 18.37 12.93 103 97319 43352 79603614
Blindness 18.32 12.93 76 97346 28307 79618659
Neurological symptom 18.31 12.93 36 97386 8747 79638219
Squamous cell carcinoma of the cervix 18.22 12.93 8 97414 249 79646717
Panic attack 18.19 12.93 68 97354 24148 79622818
Demyelination 18.09 12.93 34 97388 7989 79638977
Eczema 18.09 12.93 14 97408 40804 79606162
Foetal heart rate abnormal 18.06 12.93 9 97413 375 79646591
Drug dependence 18.05 12.93 14 97408 40755 79606211
Hip surgery 17.92 12.93 21 97401 3234 79643732
Blood lactate dehydrogenase increased 17.92 12.93 13 97409 39157 79607809
Pulmonary oedema 17.92 12.93 52 97370 88202 79558764
Abdominal pain upper 17.80 12.93 181 97241 223638 79423328
Cardiogenic shock 17.80 12.93 15 97407 41899 79605067
Endometrial cancer 17.76 12.93 17 97405 2077 79644889
Bladder operation 17.67 12.93 12 97410 897 79646069
Rash erythematous 17.64 12.93 27 97395 57742 79589224
Bronchopulmonary aspergillosis 17.62 12.93 3 97419 22291 79624675
Gastric banding 17.61 12.93 5 97417 40 79646926
Ear infection 17.58 12.93 86 97336 34346 79612620
Imminent abortion 17.56 12.93 4 97418 11 79646955
Magnetic resonance imaging head abnormal 17.42 12.93 19 97403 2707 79644259
Paralysis 17.36 12.93 45 97377 13132 79633834
Lung cancer metastatic 17.34 12.93 22 97400 3677 79643289
Mouth ulceration 17.23 12.93 13 97409 38381 79608585
Female reproductive tract disorder 17.16 12.93 8 97414 287 79646679
Urethral valves 17.13 12.93 3 97419 0 79646966
Gestational oedema 17.13 12.93 3 97419 0 79646966
Intracranial haemangioma 17.13 12.93 3 97419 0 79646966
Intervertebral disc operation 17.13 12.93 12 97410 944 79646022
Herpes zoster meningitis 17.11 12.93 7 97415 182 79646784
Lymphocyte count increased 17.09 12.93 28 97394 5904 79641062
Product administered to patient of inappropriate age 17.08 12.93 27 97395 5526 79641440
Abortion 17.06 12.93 14 97408 1396 79645570
Illness 17.02 12.93 19 97403 46492 79600474
Back disorder 16.78 12.93 41 97381 11537 79635429
Precancerous cells present 16.77 12.93 13 97409 1194 79645772
Gastrointestinal viral infection 16.73 12.93 14 97408 1434 79645532
Withdrawal syndrome 16.62 12.93 6 97416 26848 79620118
Transfusion 16.58 12.93 3 97419 21327 79625639
Hypoalbuminaemia 16.54 12.93 3 97419 21294 79625672
Fractured coccyx 16.40 12.93 12 97410 1010 79645956
Nodule 16.30 12.93 4 97418 22990 79623976
Dysgeusia 16.26 12.93 28 97394 57149 79589817
Night sweats 16.25 12.93 24 97398 52071 79594895
Cardiomegaly 16.12 12.93 6 97416 26346 79620620
Drowning 16.06 12.93 11 97411 834 79646132
Breast cyst 16.03 12.93 13 97409 1274 79645692
Diplegia 15.98 12.93 15 97407 1788 79645178
Dry eye 15.95 12.93 13 97409 36918 79610048
Melanocytic naevus 15.91 12.93 24 97398 4717 79642249
Heat exhaustion 15.88 12.93 8 97414 341 79646625
Blindness transient 15.78 12.93 24 97398 4752 79642214
HIV test positive 15.77 12.93 6 97416 128 79646838
Corneal decompensation 15.72 12.93 5 97417 61 79646905
Pertussis 15.71 12.93 11 97411 864 79646102
Neurofibroma 15.53 12.93 4 97418 21 79646945
Escherichia sepsis 15.52 12.93 33 97389 8475 79638491
Ovarian cyst 15.44 12.93 42 97380 12613 79634353
Product substitution issue 15.42 12.93 3 97419 20253 79626713
Type 2 diabetes mellitus 15.33 12.93 29 97393 57093 79589873
Jaundice 15.29 12.93 26 97396 53323 79593643
Breast cancer metastatic 15.27 12.93 33 97389 8569 79638397
Foetal heart rate decreased 15.23 12.93 4 97418 23 79646943
Oral infection 15.20 12.93 26 97396 5681 79641285
Patella fracture 15.17 12.93 15 97407 1906 79645060
Brain stem syndrome 15.13 12.93 11 97411 917 79646049
Grip strength decreased 15.12 12.93 4 97418 21865 79625101
Tenderness 15.12 12.93 5 97417 23637 79623329
Monoparesis 15.08 12.93 20 97402 3491 79643475
Renal cell carcinoma 14.99 12.93 28 97394 6550 79640416
Back injury 14.97 12.93 37 97385 10486 79636480
Wound 14.96 12.93 82 97340 116097 79530869
Drug eruption 14.95 12.93 19 97403 43916 79603050
Ligament sprain 14.77 12.93 43 97379 13421 79633545
Urinary retention 14.74 12.93 119 97303 56511 79590455
Face oedema 14.71 12.93 8 97414 28128 79618838
Pericardial effusion 14.71 12.93 21 97401 46216 79600750
Herpes zoster infection neurological 14.69 12.93 7 97415 264 79646702
Device malfunction 14.69 12.93 4 97418 21444 79625522
Astrocytoma malignant 14.68 12.93 4 97418 27 79646939
Lumbar radiculopathy 14.67 12.93 15 97407 1984 79644982
Anembryonic gestation 14.56 12.93 8 97414 408 79646558
Device extrusion 14.55 12.93 4 97418 28 79646938
Urinary tract infection enterococcal 14.51 12.93 19 97403 3276 79643690
Micturition urgency 14.48 12.93 41 97381 12600 79634366
Respiratory distress 14.47 12.93 31 97391 58308 79588658
Aggression 14.45 12.93 25 97397 50933 79596033
Abdominoplasty 14.36 12.93 5 97417 82 79646884
Gallbladder disorder 14.27 12.93 54 97368 19286 79627680
Skull fracture 14.25 12.93 14 97408 1766 79645200
Quadriplegia 14.22 12.93 19 97403 3341 79643625
Intervertebral disc disorder 14.21 12.93 23 97399 4802 79642164
Ovarian cystectomy 14.14 12.93 5 97417 86 79646880
Spinal fusion surgery 14.13 12.93 24 97398 5214 79641752
Pancreatic carcinoma metastatic 14.05 12.93 20 97402 3733 79643233
Arrhythmia 14.03 12.93 34 97388 61238 79585728
Neuralgia 14.02 12.93 79 97343 33305 79613661
Hepatic failure 13.99 12.93 34 97388 61178 79585788
Meningitis 13.96 12.93 34 97388 9548 79637418
Emotional disorder 13.96 12.93 44 97378 14343 79632623
Proteus infection 13.95 12.93 15 97407 2103 79644863
Rhinorrhoea 13.91 12.93 47 97375 76027 79570939
Poisoning deliberate 13.89 12.93 3 97419 18825 79628141
Platelet count increased 13.88 12.93 5 97417 22401 79624565
Alcoholic seizure 13.84 12.93 3 97419 6 79646960
Hepatic cytolysis 13.80 12.93 8 97414 27143 79619823
Staphylococcal osteomyelitis 13.75 12.93 6 97416 184 79646782
Clumsiness 13.72 12.93 18 97404 3109 79643857
Malignant melanoma stage III 13.67 12.93 4 97418 36 79646930
Automatic bladder 13.63 12.93 5 97417 96 79646870
Post-traumatic headache 13.63 12.93 5 97417 96 79646870
Vitamin D decreased 13.63 12.93 34 97388 9691 79637275
Benign neoplasm 13.62 12.93 11 97411 1072 79645894
Uterine cyst 13.59 12.93 7 97415 313 79646653
Lumbar puncture 13.57 12.93 6 97416 190 79646776
Vaccination complication 13.45 12.93 10 97412 863 79646103
Breast reconstruction 13.44 12.93 5 97417 100 79646866
Benign lung neoplasm 13.44 12.93 5 97417 100 79646866
Deep vein thrombosis 13.44 12.93 215 97207 120704 79526262
Dermatofibrosarcoma protuberans 13.38 12.93 4 97418 39 79646927
Vibratory sense increased 13.38 12.93 4 97418 39 79646927
Skull fractured base 13.36 12.93 7 97415 324 79646642
Abdominal adhesions 13.31 12.93 19 97403 3554 79643412
Thrombosis 13.19 12.93 159 97263 83941 79563025
Staphylococcal abscess 13.14 12.93 11 97411 1128 79645838
Vulvar dysplasia 13.09 12.93 5 97417 108 79646858
Respiratory tract infection 13.04 12.93 103 97319 48586 79598380
Device related infection 13.01 12.93 79 97343 34215 79612751
Gout 13.00 12.93 7 97415 24742 79622224
Protein S increased 12.98 12.93 3 97419 9 79646957

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA23 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D007155 Immunologic Factors
FDA MoA N0000175774 Integrin Receptor Antagonists
FDA EPC N0000175775 Integrin Receptor Antagonist

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
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
D000069442 MESH_DESCRIPTOR_UI
C1172734 UMLSCUI
7716 INN_ID
3JB47N2Q2P UNII

Pharmaceutical products:

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