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

Stem definitionDrug idCAS RN
antineoplastics, thalidomide derivatives 3317 191732-72-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lenalidomide hydrate
  • lenalidomide
  • revimid
  • revlimid
Lenalidomide is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including multiple myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including multiple myeloma. Immunomodulatory properties of lenalidomide include activation of T cells and natural killer (NK) cells, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-alpha and IL-6) by monocytes. In multiple myeloma cells, the combination of lenalidomide and dexamethasone synergizes the inhibition of cell proliferation and the induction of apoptosis.
  • Molecular weight: 259.27
  • Formula: C13H13N3O3
  • CLOGP: -0.41
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 92.50
  • ALOGS: -2.05
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 2.33 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 66 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.38 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.448 Moderate 0.77
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.284 Moderate 0.77
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 2.838 10^-6 cm/s Moderate 0.77
dh-clint Dog hepatocyte intrinsic clearance 2.529 uL/min/10^6 cells Moderate 0.77
dppb Dog plasma protein binding (% unbound) 88.730 % Moderate 0.77
fcs-ppb Fetal calf serum protein binding (% unbound) 82.650 % Moderate 0.77
herg hERG pIC50 3.904 pIC50 Moderate 0.77
hh-clint Human hepatocyte intrinsic clearance 1.291 uL/min/10^6 cells Moderate 0.77
hlm-clint Human liver microsomal intrinsic clearance 2.979 uL/min/mg protein Moderate 0.77
hppb Human plasma protein binding (% unbound) 93.670 % Moderate 0.77
kinase-safety-class ACVR2B,AURKA,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,IRAK1,ITK,KDR,KIT,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,NTRK1,PDK1,PDK2,PDK4,PRKDC,SIK2,SIK3,SRC,TEK 29
kinase-selectivity-class AURKC,AXL,CDK9,EIF2AK3,GRK2,INSR,IRAK3,MAP3K7,MAPK1,MAPK8,PDK1,SIK2,STK33,TEK 14
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.365 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.128 Moderate 0.77
mh-clint Mouse hepatocyte intrinsic clearance 1.406 Moderate 0.77
mppb Mouse plasma protein binding (% unbound) 92.750 Moderate 0.77
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 3.648 Moderate 0.77
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 92.890 % Moderate 0.77
rh-clint Rat hepatocyte intrinsic clearance 0.946 uL/min/10^6 cells Moderate 0.77
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.210 % Moderate 0.77
rppb Rat plasma protein binding (% unbound) 89.180 % Moderate 0.77
solubility-dd Solubility at pH 7.4 in DMSO 928.966 uM Moderate 0.77

Approvals:

DateAgencyCompanyOrphan
June 14, 2007 EMA CELEGENE EUROPE BV
Dec. 27, 2005 FDA CELGENE
June 25, 2010 PMDA Celgene K.K.

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
Diarrhoea 8395.05 14.78 13475 322473 925715 89366784
Death 7377.99 14.78 8741 327207 447810 89844689
Full blood count decreased 7121.69 14.78 3025 332923 26664 90265835
White blood cell count decreased 5481.09 14.78 4706 331242 162403 90130096
Neuropathy peripheral 5295.95 14.78 4244 331704 132726 90159773
Thrombosis 4079.99 14.78 2828 333120 70423 90222076
Platelet count decreased 3532.26 14.78 3372 332576 133597 90158902
Pneumonia 2816.76 14.78 6838 329110 631221 89661278
Laboratory test abnormal 2671.06 14.78 1759 334189 40095 90252404
Neutropenia 2288.14 14.78 3446 332502 221458 90071041
Constipation 2218.88 14.78 3832 332116 276563 90015936
Fatigue 2216.02 14.78 9272 326676 1144751 89147748
Plasma cell myeloma 2062.45 14.78 1486 334462 39342 90253157
Human chorionic gonadotropin increased 1963.43 14.78 578 335370 1368 90291131
Unevaluable event 1822.81 14.78 1559 334389 53289 90239210
Rash 1720.40 14.78 6645 329303 789455 89503044
Muscle spasms 1409.00 14.78 2972 332976 248911 90043588
Plasma cell myeloma recurrent 1327.56 14.78 523 335425 3705 90288794
Product dose omission issue 1325.32 14.78 3168 332780 288519 90003980
Systemic lupus erythematosus 1239.99 14.78 20 335928 361876 89930623
Deep vein thrombosis 1237.44 14.78 1610 334338 90010 90202489
Condition aggravated 1220.01 14.78 349 335599 595196 89697303
Maternal exposure during pregnancy 1193.39 14.78 30 335918 360033 89932466
Blood potassium decreased 1164.10 14.78 1141 334807 46586 90245913
Rheumatoid arthritis 1138.72 14.78 48 335900 362566 89929933
Haemoglobin decreased 1135.80 14.78 2102 333846 159854 90132645
Drug ineffective 1093.16 14.78 2186 333762 1382112 88910387
Contraindicated product administered 1052.08 14.78 29 335919 320110 89972389
Synovitis 1040.85 14.78 42 335906 329710 89962789
Neutrophil count decreased 982.91 14.78 1268 334680 70264 90222235
Adverse drug reaction 960.34 14.78 1625 334323 115076 90177423
Pancytopenia 959.88 14.78 1652 334296 118611 90173888
COVID-19 942.88 14.78 1992 333956 166851 90125648
Glossodynia 906.65 14.78 77 335871 321702 89970797
Thrombocytopenia 852.80 14.78 2178 333770 206547 90085952
Ageusia 820.36 14.78 589 335359 15487 90277012
Tooth disorder 812.16 14.78 772 335176 30318 90262181
Pericarditis 788.15 14.78 55 335893 270096 90022403
Infusion related reaction 787.40 14.78 281 335667 416499 89876000
Red blood cell count decreased 777.94 14.78 909 335039 45442 90247057
Skin discolouration 775.52 14.78 888 335060 43427 90249072
Helicobacter infection 743.42 14.78 21 335927 226829 90065670
Urinary tract infection 743.34 14.78 2656 333292 302976 89989523
Anaemia 737.96 14.78 2921 333027 349881 89942618
Folliculitis 728.25 14.78 5 335943 204348 90088151
Exposure during pregnancy 696.97 14.78 48 335900 238362 90054137
Product use issue 695.87 14.78 182 335766 329737 89962762
Wound 695.13 14.78 139 335809 302841 89989658
Dehydration 668.36 14.78 1904 334044 192543 90099956
Product use in unapproved indication 662.22 14.78 211 335737 336025 89956474
Cytopenia 658.24 14.78 534 335414 16915 90275584
Type 2 diabetes mellitus 654.46 14.78 22 335926 203222 90089277
Renal disorder 639.53 14.78 745 335203 37114 90255385
Fibromyalgia 635.05 14.78 31 335917 206238 90086261
Drug hypersensitivity 633.75 14.78 476 335472 463133 89829366
Mobility decreased 632.70 14.78 89 335859 250645 90041854
Discomfort 618.63 14.78 131 335817 274204 90018295
Treatment failure 612.35 14.78 183 335765 303745 89988754
Asthenia 608.58 14.78 3715 332233 530036 89762463
Muscle injury 607.87 14.78 9 335939 176645 90115854
Drug interaction 603.29 14.78 142 335806 276311 90016188
Impaired healing 570.54 14.78 92 335856 234107 90058392
Pulmonary thrombosis 570.48 14.78 389 335559 9393 90283106
Rash pruritic 558.19 14.78 1053 334895 81161 90211338
Injection site pain 555.02 14.78 20 335928 173679 90118820
Cardiac disorder 540.96 14.78 846 335102 56026 90236473
Renal failure 540.78 14.78 1373 334575 129634 90162865
Plasmacytoma 540.60 14.78 245 335703 2548 90289951
Therapeutic product effect decreased 539.70 14.78 178 335770 277393 90015106
Wheezing 538.15 14.78 113 335835 237967 90054532
Liver injury 511.37 14.78 30 335918 170537 90121962
Injury 505.04 14.78 67 335881 197282 90095217
Pulmonary embolism 498.88 14.78 1331 334617 129489 90163010
Completed suicide 496.47 14.78 8 335940 145050 90147449
Rheumatoid factor positive 491.73 14.78 38 335910 171612 90120887
Hip fracture 486.86 14.78 607 335341 32470 90260029
Hepatic enzyme increased 477.95 14.78 382 335566 360354 89932145
Arthralgia 472.14 14.78 1406 334542 777116 89515383
Joint range of motion decreased 470.61 14.78 6 335942 135637 90156862
Blood cholesterol increased 459.38 14.78 104 335844 207908 90084591
B-cell type acute leukaemia 433.77 14.78 139 335809 480 90292019
Fall 433.05 14.78 3162 332786 478648 89813851
Lower respiratory tract infection 432.08 14.78 194 335754 250465 90042034
Full blood count abnormal 425.07 14.78 598 335350 35999 90256500
Irritable bowel syndrome 406.74 14.78 131 335817 207317 90085182
Sepsis 404.80 14.78 1525 334423 178289 90114210
Cataract 404.76 14.78 853 335095 71239 90221260
Pain 396.29 14.78 2127 333821 994214 89298285
C-reactive protein abnormal 395.86 14.78 18 335930 127411 90165088
Seasonal allergy 392.69 14.78 455 335493 22528 90269971
Osteoarthritis 391.97 14.78 119 335829 195611 90096888
Ill-defined disorder 385.77 14.78 104 335844 184787 90107712
Disease progression 380.88 14.78 1362 334586 155253 90137246
Migraine 368.37 14.78 123 335825 190269 90102230
Psoriasis 366.66 14.78 55 335893 147699 90144800
Headache 361.83 14.78 1808 334140 860938 89431561
Multiple allergies 361.51 14.78 358 335590 14788 90277711
Peripheral swelling 358.90 14.78 2690 333258 410416 89882083
Overdose 358.05 14.78 74 335874 157635 90134864
Obesity 356.16 14.78 7 335941 105500 90186999
Hypercholesterolaemia 352.05 14.78 4 335944 100888 90191611
Light chain analysis increased 350.52 14.78 152 335796 1410 90291089
Hypertension 346.14 14.78 737 335211 456795 89835704
Dry skin 343.67 14.78 904 335044 87169 90205330
Musculoskeletal stiffness 341.54 14.78 357 335591 296175 89996324
Therapeutic product effect incomplete 337.35 14.78 148 335800 193748 90098751
Spinal fracture 336.83 14.78 412 335536 21604 90270895
Cerebrovascular accident 334.93 14.78 1114 334834 122419 90170080
Gastric disorder 330.55 14.78 506 335442 32878 90259621
Bursitis 326.68 14.78 49 335899 131605 90160894
Swelling 324.53 14.78 666 335282 418392 89874107
Prescribed overdose 312.64 14.78 11 335937 97614 90194885
Blister 312.05 14.78 291 335657 254707 90037792
Atrial fibrillation 307.11 14.78 1141 334807 132470 90160029
Full blood count increased 304.97 14.78 129 335819 1119 90291380
General physical health deterioration 304.21 14.78 531 335417 354584 89937915
Alopecia 300.26 14.78 893 335055 494178 89798321
Grip strength decreased 297.98 14.78 10 335938 92566 90199933
Influenza 296.01 14.78 1160 334788 138104 90154395
Plasma cell myeloma refractory 291.25 14.78 119 335829 937 90291562
Drug abuse 288.52 14.78 3 335945 82344 90210155
Inflammation 285.28 14.78 153 335795 178439 90114060
Blood test abnormal 282.28 14.78 368 335580 20584 90271915
Acute myeloid leukaemia 280.38 14.78 364 335584 20276 90272223
Knee arthroplasty 278.84 14.78 6 335942 83176 90209323
Hypersensitivity 278.66 14.78 816 335132 453861 89838638
Renal impairment 272.79 14.78 936 335012 104485 90188014
Protein total increased 272.31 14.78 167 335781 3342 90289157
Acute lymphocytic leukaemia 261.32 14.78 151 335797 2697 90289802
C-reactive protein increased 255.53 14.78 180 335768 181209 90111290
Plasma cell leukaemia 254.35 14.78 111 335837 1047 90291452
Peripheral venous disease 253.80 14.78 14 335934 83907 90208592
Monoclonal immunoglobulin present 253.70 14.78 134 335814 1990 90290509
Live birth 253.01 14.78 9 335939 79098 90213401
Myelodysplastic syndrome 252.33 14.78 348 335600 20555 90271944
Injection site erythema 250.59 14.78 34 335914 98468 90194031
Sleep disorder 249.37 14.78 220 335728 197810 90094689
Lip dry 247.20 14.78 39 335909 100916 90191583
Hip arthroplasty 246.09 14.78 8 335940 76200 90216299
Autoimmune disorder 244.51 14.78 9 335939 76735 90215764
Intentional product misuse 242.62 14.78 25 335923 89579 90202920
Wound infection 239.27 14.78 51 335897 106351 90186148
Lactose intolerance 235.39 14.78 150 335798 3219 90289280
Body height decreased 233.97 14.78 254 335694 11695 90280804
Bone pain 233.45 14.78 628 335320 61355 90231144
Hordeolum 229.07 14.78 170 335778 4708 90287791
Injection site reaction 224.49 14.78 36 335912 92044 90200455
Arthropathy 223.04 14.78 659 335289 365583 89926916
Musculoskeletal pain 222.01 14.78 185 335763 171066 90121433
Medication error 218.25 14.78 28 335920 84624 90207875
Pruritus 215.83 14.78 3004 332944 538521 89753978
Suicide attempt 215.00 14.78 17 335931 75382 90217117
COVID-19 pneumonia 212.51 14.78 298 335650 17879 90274620
Weight increased 210.88 14.78 816 335132 417111 89875388
Dysgeusia 210.63 14.78 545 335403 52015 90240484
Herpes zoster 208.10 14.78 797 335151 93847 90198652
Product quality issue 207.53 14.78 25 335923 79300 90213199
Back pain 204.65 14.78 1933 334015 315242 89977257
Asthma 204.62 14.78 365 335583 241795 90050704
Depression 202.35 14.78 515 335433 300086 89992413
Tachycardia 195.09 14.78 178 335770 157495 90135004
Osteolysis 194.81 14.78 136 335812 3414 90289085
Epilepsy 194.09 14.78 35 335913 82171 90210328
Clostridium difficile infection 192.04 14.78 419 335529 35826 90256673
Blood magnesium decreased 189.03 14.78 261 335687 15432 90277067
Tremor 188.42 14.78 1089 334859 152084 90140415
Red blood cell sedimentation rate increased 186.91 14.78 39 335909 82556 90209943
Myelodysplastic syndrome transformation 185.66 14.78 68 335880 383 90292116
Cardiac failure congestive 185.04 14.78 791 335157 97903 90194596
Inappropriate schedule of product administration 184.63 14.78 170 335778 149763 90142736
Drug-induced liver injury 180.57 14.78 55 335893 90263 90202236
Gallbladder disorder 179.15 14.78 288 335660 19515 90272984
Abdominal discomfort 179.12 14.78 1037 334911 476291 89816208
Bone erosion 177.02 14.78 4 335944 53017 90239482
Pulmonary fibrosis 176.23 14.78 89 335859 107414 90185085
Wrong technique in product usage process 172.19 14.78 29 335919 71542 90220957
Loss of personal independence in daily activities 171.55 14.78 151 335797 135954 90156545
Bronchitis 171.30 14.78 1061 334887 151866 90140633
Anaphylactic reaction 168.42 14.78 57 335891 87467 90205032
Upper limb fracture 167.46 14.78 293 335655 21285 90271214
Injection site swelling 166.47 14.78 15 335933 59824 90232675
Oxygen saturation decreased 165.94 14.78 96 335852 107387 90185112
Flatulence 163.75 14.78 427 335521 40940 90251559
Dementia 163.56 14.78 307 335641 23554 90268945
Injection site pruritus 162.72 14.78 9 335939 53825 90238674
Joint swelling 161.46 14.78 1147 334801 502153 89790346
Injection site bruising 160.44 14.78 8 335940 52299 90240200
Suicidal ideation 155.00 14.78 41 335907 73814 90218685
SARS-CoV-2 test positive 152.31 14.78 197 335751 10931 90281568
Squamous cell carcinoma of skin 152.27 14.78 162 335786 7287 90285212
Decreased appetite 151.88 14.78 2094 333854 374446 89918053
Gout 150.89 14.78 244 335704 16615 90275884
Coeliac disease 150.37 14.78 3 335945 44607 90247892
Depressed level of consciousness 149.76 14.78 42 335906 72742 90219757
Pregnancy 149.58 14.78 25 335923 62022 90230477
Abortion spontaneous 146.55 14.78 15 335933 54041 90238458
Immune system disorder 146.40 14.78 200 335748 11705 90280794
Underdose 143.85 14.78 16 335932 54001 90238498
Colitis ulcerative 143.71 14.78 25 335923 60241 90232258
Incorrect route of product administration 142.71 14.78 12 335936 50614 90241885
Prescribed underdose 140.66 14.78 51 335897 74968 90217531
Sedation 139.78 14.78 10 335938 48161 90244338
Blood pressure systolic increased 139.57 14.78 24 335924 58321 90234178
Foot deformity 139.52 14.78 26 335922 59625 90232874
Delirium 138.63 14.78 110 335838 104249 90188250
Blepharospasm 136.68 14.78 21 335927 55424 90237075
Road traffic accident 131.34 14.78 123 335825 107503 90184996
Bone lesion 129.83 14.78 139 335809 6298 90286201
Aspartate aminotransferase increased 125.19 14.78 118 335830 102819 90189680
Lung disorder 123.79 14.78 229 335719 149654 90142845
Disability 122.57 14.78 7 335941 40738 90251761
Alanine aminotransferase increased 122.54 14.78 155 335793 118183 90174316
Hepatic cirrhosis 122.03 14.78 41 335907 63212 90229287
Premature delivery 121.92 14.78 5 335943 38757 90253742
Illness 120.51 14.78 612 335336 81357 90211142
Feeling abnormal 120.35 14.78 1044 334904 166191 90126308
Anxiety 119.29 14.78 667 335281 309105 89983394
Fracture 118.99 14.78 257 335691 21819 90270680
Drug ineffective for unapproved indication 118.83 14.78 49 335899 66595 90225904
Hyponatraemia 117.56 14.78 196 335752 133342 90159157
Oedema 117.08 14.78 367 335581 199928 90092571
Muscle spasticity 116.63 14.78 3 335945 35319 90257180
Diverticulitis 113.17 14.78 397 335551 44790 90247709
Incorrect dose administered 112.86 14.78 77 335871 78853 90213646
Sciatica 112.21 14.78 126 335822 101256 90191243
Onychomadesis 112.07 14.78 18 335930 45980 90246519
Joint stiffness 110.44 14.78 77 335871 77965 90214534
Therapy interrupted 110.14 14.78 422 335526 49686 90242813
Coma 109.11 14.78 67 335881 72565 90219934
Pregnancy test false positive 107.39 14.78 40 335908 238 90292261
Hypoglycaemia 106.93 14.78 63 335885 69785 90222714
Rhabdomyolysis 106.53 14.78 29 335919 51227 90241272
Tumour flare 105.07 14.78 49 335899 547 90291952
Nail disorder 104.39 14.78 44 335904 59023 90233476
Pathological fracture 103.58 14.78 152 335796 9508 90282991
Exposure via body fluid 102.93 14.78 49 335899 575 90291924
Confusional state 100.81 14.78 930 335018 385275 89907224
Breast cancer stage II 100.64 14.78 8 335940 35326 90257173
Coronavirus infection 98.95 14.78 112 335836 5403 90287096
Gait disturbance 98.05 14.78 565 335383 259931 90032568
Monoclonal immunoglobulin increased 97.85 14.78 42 335906 379 90292120
Gait inability 97.61 14.78 252 335696 146204 90146295
Eye disorder 97.61 14.78 272 335676 27118 90265381
Skin exfoliation 97.00 14.78 503 335445 67410 90225089
Uterine disorder 95.90 14.78 87 335861 3214 90289285
Walking aid user 95.87 14.78 10 335938 35496 90257003
Stomatitis 95.44 14.78 611 335337 274087 90018412
Spinal compression fracture 95.09 14.78 188 335760 14990 90277509
Clostridium difficile colitis 94.97 14.78 265 335683 26441 90266058
Hepatitis 93.40 14.78 75 335873 70664 90221835
Exostosis 93.23 14.78 40 335908 53094 90239405
Acute leukaemia 93.01 14.78 57 335891 1139 90291360
Sinus disorder 92.70 14.78 310 335638 34137 90258362
Cellulitis 92.57 14.78 618 335330 90719 90201780
White blood cell count abnormal 92.17 14.78 126 335822 7378 90285121
Procedural pain 91.10 14.78 9 335939 33351 90259148
Swelling face 90.15 14.78 563 335385 80789 90211710
Abdominal pain 89.95 14.78 985 334963 394736 89897763
Vision blurred 89.75 14.78 708 335240 109585 90182914
Compression fracture 89.51 14.78 135 335813 8654 90283845
Rash macular 89.15 14.78 281 335667 29999 90262500
Lymphoma 88.38 14.78 171 335777 13420 90279079
Hypoacusis 88.09 14.78 265 335683 27585 90264914
Back disorder 87.88 14.78 251 335697 25380 90267119
Cardiac amyloidosis 87.34 14.78 52 335896 984 90291515
Electrocardiogram QT prolonged 87.00 14.78 84 335864 72372 90220127
Eye infection 86.24 14.78 174 335774 14080 90278419
Tumour lysis syndrome 85.97 14.78 151 335797 11001 90281498
Blood creatine phosphokinase increased 85.91 14.78 12 335936 34011 90258488
Amyloidosis 85.47 14.78 55 335893 1201 90291298
Intentional self-injury 85.37 14.78 6 335942 29328 90263171
Injection site haemorrhage 84.77 14.78 5 335943 28313 90264186
Blood iron decreased 84.42 14.78 198 335750 17761 90274738
B precursor type acute leukaemia 84.08 14.78 33 335915 231 90292268
Onychomycosis 83.83 14.78 18 335930 37358 90255141
Product distribution issue 83.68 14.78 85 335863 3620 90288879
Device issue 83.26 14.78 7 335941 29530 90262969
Drug withdrawal syndrome 83.23 14.78 6 335942 28717 90263782
Papule 83.05 14.78 124 335824 7878 90284621
Drug level increased 82.80 14.78 5 335943 27757 90264742
Bone marrow failure 82.34 14.78 285 335663 31936 90260563
Eye swelling 82.24 14.78 268 335680 29118 90263381
Device dislocation 82.15 14.78 10 335938 31472 90261027
Agitation 81.48 14.78 77 335871 67021 90225478
Increased tendency to bruise 80.27 14.78 152 335796 11738 90280761
Surgery 80.03 14.78 33 335915 44854 90247645
Respiratory syncytial virus infection 79.63 14.78 141 335807 10339 90282160
Muscular weakness 79.51 14.78 445 335503 206221 90086278
Viral infection 79.19 14.78 334 335614 41080 90251419
Oedema peripheral 78.09 14.78 1367 334581 256548 90035951
Dizziness 77.66 14.78 2790 333158 586494 89706005
Transient ischaemic attack 77.03 14.78 341 335607 42835 90249664
Myositis 76.27 14.78 3 335945 24125 90268374
Blood pressure increased 76.22 14.78 424 335524 196793 90095706
Feeling jittery 76.14 14.78 173 335775 15198 90277301
Interstitial lung disease 76.09 14.78 103 335845 76302 90216197
Skin cancer 75.87 14.78 160 335788 13359 90279140
Stem cell transplant 75.12 14.78 63 335885 2091 90290408
Hypogeusia 75.02 14.78 55 335893 1494 90291005
Rib fracture 74.81 14.78 242 335706 26193 90266306
Osteoporosis 74.05 14.78 154 335794 96377 90196122
Adenocarcinoma of colon 73.87 14.78 70 335878 2736 90289763
Premature baby 73.36 14.78 5 335943 25072 90267427
Gamma-glutamyltransferase increased 72.51 14.78 25 335923 37927 90254572
Haematotoxicity 72.27 14.78 150 335798 12385 90280114
Bradycardia 72.00 14.78 125 335823 83722 90208777
Metabolic acidosis 71.07 14.78 61 335887 55615 90236884
Accidental exposure to product 71.04 14.78 34 335914 42332 90250167
Dermatitis atopic 70.70 14.78 4 335944 23468 90269031
Nervousness 70.12 14.78 281 335667 33775 90258724
Vomiting 68.27 14.78 2316 333632 785977 89506522
Blood pressure fluctuation 67.42 14.78 57 335891 52356 90240143
Taste disorder 66.98 14.78 424 335524 61122 90231377
Emotional distress 66.92 14.78 26 335922 36636 90255863
Neuralgia 66.54 14.78 262 335686 31238 90261261
Gastrooesophageal reflux disease 66.26 14.78 354 335594 165983 90126516
Liver function test increased 66.25 14.78 134 335814 84721 90207778
Leukaemia 66.18 14.78 87 335861 4905 90287594
Hypercalcaemia 66.14 14.78 277 335671 33963 90258536
Therapeutic response shortened 65.66 14.78 5 335943 22874 90269625
Dysarthria 65.60 14.78 63 335885 54419 90238080
Liver disorder 65.47 14.78 230 335718 121039 90171460
Drug tolerance decreased 65.24 14.78 19 335929 32111 90260388
Localised infection 65.21 14.78 272 335676 33290 90259209
Light chain analysis abnormal 65.20 14.78 25 335923 163 90292336
Metastases to liver 64.35 14.78 14 335934 28793 90263706
Hyperviscosity syndrome 64.25 14.78 27 335921 230 90292269
Tooth infection 63.87 14.78 192 335756 19978 90272521
Blood electrolytes decreased 63.20 14.78 49 335899 1451 90291048
Joint dislocation 63.06 14.78 44 335904 44538 90247961
Treatment delayed 62.26 14.78 31 335917 404 90292095
Intraductal proliferative breast lesion 61.74 14.78 70 335878 3383 90289116
Eczema 61.51 14.78 63 335885 52807 90239692
Multiple sclerosis 61.25 14.78 14 335934 27826 90264673
Lactic acidosis 61.17 14.78 58 335890 50405 90242094
Blood calcium increased 61.16 14.78 137 335811 11921 90280578
Therapeutic response decreased 60.85 14.78 153 335795 89576 90202923
Angioedema 60.12 14.78 92 335856 64784 90227715
White blood cell disorder 59.77 14.78 64 335884 2900 90289599
Platelet count abnormal 59.73 14.78 77 335871 4258 90288241
Osteonecrosis of jaw 59.61 14.78 295 335653 38808 90253691
Dysphonia 58.68 14.78 418 335530 62666 90229833
Platelet disorder 58.60 14.78 57 335891 2302 90290197
Laryngitis 58.46 14.78 61 335887 50692 90241807
Vitamin D decreased 58.42 14.78 134 335814 11845 90280654
Endometrial adenocarcinoma 58.13 14.78 46 335902 1404 90291095
Pallor 57.93 14.78 27 335921 34138 90258361
Infusion site pain 57.55 14.78 4 335944 19734 90272765
Skin hyperpigmentation 57.06 14.78 96 335852 6755 90285744
Breast cancer 57.04 14.78 368 335580 53393 90239106
Respiratory arrest 56.99 14.78 26 335922 33285 90259214
Obstructive airways disorder 56.93 14.78 13 335935 25856 90266643
Withdrawal syndrome 56.74 14.78 8 335940 22516 90269983
Blood pressure abnormal 56.64 14.78 181 335767 19464 90273035
Blood calcium decreased 56.61 14.78 242 335706 29940 90262559
Blood pressure diastolic decreased 56.08 14.78 15 335933 26811 90265688
Hyperkalaemia 55.64 14.78 97 335851 64867 90227632
Blood alkaline phosphatase increased 55.13 14.78 58 335890 48021 90244478
Failure to thrive 54.90 14.78 106 335842 8305 90284194
Chest discomfort 54.25 14.78 296 335652 138069 90154430
No adverse event 54.24 14.78 106 335842 67876 90224623
Malignant melanoma 54.11 14.78 134 335814 12442 90280057
Blood potassium abnormal 54.05 14.78 61 335887 2933 90289566
Device malfunction 53.91 14.78 7 335941 20970 90271529
Impaired work ability 53.34 14.78 5 335943 19321 90273178
Oral disorder 52.99 14.78 118 335830 10227 90282272
Erythema 52.68 14.78 569 335379 228677 90063822
Anaphylactic shock 52.06 14.78 26 335922 31591 90260908
Nerve injury 51.71 14.78 122 335826 10984 90281515
Affect lability 51.69 14.78 4 335944 18059 90274440
Oral pain 51.56 14.78 249 335699 32434 90260065
Frequent bowel movements 51.55 14.78 82 335866 56853 90235646
Therapy partial responder 51.22 14.78 189 335759 21854 90270645
Human chorionic gonadotropin abnormal 50.90 14.78 14 335934 23 90292476
Abnormal behaviour 50.54 14.78 11 335937 22617 90269882
Back injury 50.43 14.78 59 335889 46563 90245936
Disease complication 50.41 14.78 66 335882 3706 90288793
Gastrointestinal motility disorder 50.27 14.78 85 335863 6006 90286493
Protein total abnormal 49.73 14.78 30 335918 582 90291917
Weight decreased 49.28 14.78 1796 334152 378114 89914385
Body temperature decreased 48.51 14.78 14 335934 23802 90268697
Chronic sinusitis 48.47 14.78 14 335934 23788 90268711
Paraesthesia 48.44 14.78 1243 334705 249083 90043416
Arthritis 48.44 14.78 392 335556 166923 90125576
Extrapyramidal disorder 48.43 14.78 3 335945 16300 90276199
Septic shock 48.35 14.78 501 335447 83659 90208840
Female genital tract fistula 48.32 14.78 5 335943 17863 90274636
Palpitations 48.02 14.78 303 335645 136425 90156074
Balance disorder 48.01 14.78 561 335387 96519 90195980
Pulmonary arterial hypertension 47.09 14.78 19 335929 26168 90266331
Invasive ductal breast carcinoma 46.78 14.78 95 335853 7723 90284776
Poor venous access 46.77 14.78 8 335940 19519 90272980
Peripheral coldness 46.62 14.78 135 335813 13757 90278742
Impaired quality of life 46.42 14.78 14 335934 23130 90269369
Vitamin B12 decreased 46.36 14.78 76 335872 5234 90287265
Pneumonia influenzal 46.29 14.78 49 335899 2191 90290308
Febrile infection 45.88 14.78 47 335901 2022 90290477
Colon cancer 45.40 14.78 115 335833 10829 90281670
Hypogammaglobulinaemia 45.16 14.78 113 335835 10561 90281938
Heart rate increased 45.10 14.78 240 335708 112662 90179837
Diabetic ketoacidosis 45.06 14.78 17 335931 24390 90268109
Dystonia 44.73 14.78 5 335943 16814 90275685
Pelvic fracture 44.59 14.78 141 335807 15078 90277421
Polyneuropathy 44.24 14.78 165 335783 19176 90273323
Stress 44.18 14.78 154 335794 81241 90211258
Hot flush 44.13 14.78 374 335574 59114 90233385
Sleep apnoea syndrome 44.02 14.78 32 335916 31715 90260784
Blood calcium abnormal 44.00 14.78 45 335903 1932 90290567
Rales 43.93 14.78 4 335944 15823 90276676
Therapy change 43.84 14.78 96 335852 8226 90284273
Nail discolouration 43.75 14.78 57 335891 3185 90289314
Motor dysfunction 43.66 14.78 9 335939 19221 90273278
Product prescribing error 43.64 14.78 29 335919 30116 90262383
Generalised tonic-clonic seizure 43.62 14.78 39 335909 34864 90257635
Normal newborn 43.59 14.78 16 335932 23346 90269153
Muscle strain 43.58 14.78 105 335843 9582 90282917
Sputum discoloured 43.39 14.78 11 335937 20380 90272119
Cytokine release syndrome 43.32 14.78 212 335736 27761 90264738
Ascites 43.00 14.78 69 335879 47671 90244828
General symptom 42.69 14.78 3 335945 14665 90277834
Hypoaesthesia 42.60 14.78 1493 334455 312717 89979782
Hepatotoxicity 42.48 14.78 65 335883 45777 90246722
Pneumonia respiratory syncytial viral 42.01 14.78 37 335911 1314 90291185
Dyskinesia 41.97 14.78 44 335904 36490 90256009
Incorrect product administration duration 41.94 14.78 10 335938 19312 90273187
Hepatic steatosis 41.88 14.78 45 335903 36900 90255599
Nausea 41.64 14.78 4711 331237 1105605 89186894
Spinal disorder 41.63 14.78 116 335832 11563 90280936
Myoclonus 41.45 14.78 10 335938 19158 90273341
Muscle rigidity 41.43 14.78 3 335945 14306 90278193
Blood magnesium abnormal 41.31 14.78 28 335920 669 90291830
Night sweats 40.90 14.78 294 335654 128472 90164027
Tachypnoea 40.77 14.78 14 335934 21295 90271204
Respiratory depression 40.51 14.78 5 335943 15570 90276929
Device breakage 40.50 14.78 3 335945 14041 90278458
Metastases to bone 40.48 14.78 22 335926 25483 90267016
Vaginal discharge 40.47 14.78 11 335937 19453 90273046
Myeloma cast nephropathy 40.33 14.78 17 335931 146 90292353
Depressed mood 40.33 14.78 78 335870 50144 90242355
Transaminases increased 40.30 14.78 47 335901 37145 90255354
Ear swelling 40.10 14.78 42 335906 1855 90290644
Bone disorder 40.03 14.78 181 335767 22939 90269560
Chest pain 39.74 14.78 892 335056 318753 89973746
Rhinorrhoea 39.17 14.78 500 335448 87816 90204683
Therapeutic response unexpected 39.14 14.78 16 335932 21864 90270635
Traumatic fracture 39.09 14.78 28 335920 733 90291766
Food poisoning 39.07 14.78 69 335879 5049 90287450
Transformation to acute myeloid leukaemia 38.87 14.78 22 335926 377 90292122
Flushing 38.84 14.78 182 335766 88309 90204190
Dry eye 38.73 14.78 356 335592 57575 90234924
Neutrophil count abnormal 38.66 14.78 61 335887 4067 90288432
Neutrophil count increased 38.40 14.78 12 335936 19378 90273121
Unresponsive to stimuli 38.35 14.78 51 335897 38070 90254429
Dyspnoea 38.23 14.78 2781 333167 878174 89414325
Hallucination, visual 38.01 14.78 19 335929 23073 90269426
Seizure 37.85 14.78 372 335576 152257 90140242
Kidney infection 37.73 14.78 193 335755 25723 90266776
Myocardial infarction 37.72 14.78 577 335371 105395 90187104
Pigmentation disorder 37.65 14.78 74 335874 5875 90286624
Protein total decreased 37.60 14.78 82 335866 7007 90285492
Coordination abnormal 37.59 14.78 16 335932 21340 90271159
Gingival bleeding 37.36 14.78 131 335817 14772 90277727
Cardio-respiratory arrest 37.35 14.78 115 335833 63025 90229474
Malignant neoplasm of unknown primary site 37.05 14.78 20 335928 311 90292188
Uveitis 37.04 14.78 7 335941 15896 90276603
Red blood cell count abnormal 37.00 14.78 34 335914 1277 90291222
Polyarthritis 36.99 14.78 11 335937 18339 90274160
Toxic epidermal necrolysis 36.45 14.78 40 335908 32488 90260011
Urticaria 36.29 14.78 882 335066 311852 89980647
Refractory cytopenia with multilineage dysplasia 35.98 14.78 15 335933 125 90292374
Schizophrenia 35.96 14.78 6 335942 14908 90277591
Pulmonary oedema 35.86 14.78 370 335578 61710 90230789
Paraproteinaemia 35.85 14.78 18 335930 239 90292260
Liver function test decreased 35.82 14.78 13 335935 71 90292428
Rhinitis allergic 35.82 14.78 9 335939 16776 90275723
Middle insomnia 35.72 14.78 9 335939 16742 90275757
Pneumonia pneumococcal 35.68 14.78 47 335901 2655 90289844
Blood disorder 35.65 14.78 85 335863 7705 90284794
Injection site rash 35.33 14.78 23 335925 24150 90268349
Fear 35.31 14.78 9 335939 16613 90275886
Iron deficiency anaemia 35.29 14.78 22 335926 23640 90268859
Metastases to lung 35.26 14.78 8 335940 15983 90276516
Heavy menstrual bleeding 35.16 14.78 16 335932 20514 90271985
Basal cell carcinoma 35.08 14.78 228 335720 33161 90259338
Product administration error 34.89 14.78 28 335920 26395 90266104
Poisoning 34.80 14.78 7 335941 15210 90277289
Adverse event 34.66 14.78 620 335328 116798 90175701
Performance status decreased 34.36 14.78 59 335889 4221 90288278
Parainfluenzae virus infection 34.33 14.78 47 335901 2756 90289743
Dry mouth 34.26 14.78 478 335470 183581 90108918
Viral upper respiratory tract infection 34.03 14.78 89 335859 8545 90283954
Leukocytosis 33.75 14.78 39 335909 30951 90261548
White blood cell count 33.62 14.78 13 335935 87 90292412
Complication associated with device 33.55 14.78 15 335933 19434 90273065
Gastrointestinal infection 33.28 14.78 103 335845 10887 90281612
Lower limb fracture 33.24 14.78 182 335766 84831 90207668
Large intestine infection 33.22 14.78 45 335903 2612 90289887
Parkinsonism 33.17 14.78 6 335942 14059 90278440
Upper respiratory tract infection 32.88 14.78 663 335285 127655 90164844
Crying 32.84 14.78 28 335920 25617 90266882
Right ventricular failure 32.84 14.78 15 335933 19190 90273309
Product storage error 32.80 14.78 17 335931 20224 90272275
Gingival pain 32.58 14.78 94 335854 9558 90282941
Plasma cell myeloma in remission 32.36 14.78 8 335940 6 90292493
Radiculopathy 32.35 14.78 14 335934 18491 90274008
Personality disorder 32.35 14.78 4 335944 12440 90280059
Acute hepatic failure 32.26 14.78 22 335926 22539 90269960
Full blood count 32.21 14.78 7 335941 0 90292499
Ulcer haemorrhage 32.20 14.78 30 335918 26291 90266208
Angina pectoris 32.16 14.78 60 335888 39100 90253399
Cyanosis 32.03 14.78 16 335932 19439 90273060
Status epilepticus 31.87 14.78 15 335933 18859 90273640
Bronchiectasis 31.63 14.78 22 335926 22308 90270191
Blood pressure diastolic increased 31.55 14.78 5 335943 12901 90279598
Bone marrow disorder 31.49 14.78 47 335901 2985 90289514
Intestinal obstruction 31.10 14.78 240 335708 36891 90255608
Transplant rejection 31.06 14.78 5 335943 12753 90279746
Sinusitis 30.99 14.78 1002 334946 342086 89950413
Dyspnoea exertional 30.95 14.78 150 335798 72138 90220361
Transfusion 30.94 14.78 13 335935 17475 90275024
Blood immunoglobulin G increased 30.76 14.78 46 335902 2926 90289573
Hypokinesia 30.58 14.78 10 335938 15687 90276812
Hemiparesis 30.57 14.78 44 335904 31775 90260724
Abortion induced 30.47 14.78 4 335944 11884 90280615
Pancreatitis 30.42 14.78 144 335804 69682 90222817
Pneumococcal sepsis 30.27 14.78 26 335922 892 90291607
Lung adenocarcinoma 30.23 14.78 65 335883 5500 90286999
Agranulocytosis 30.21 14.78 52 335896 34950 90257549
Hypothermia 30.21 14.78 10 335938 15565 90276934
Psychotic disorder 30.19 14.78 43 335905 31187 90261312
Blood immunoglobulin A increased 30.01 14.78 30 335918 1253 90291246
Infusion site erythema 29.82 14.78 7 335941 13663 90278836
Precursor B-lymphoblastic lymphoma 29.81 14.78 9 335939 24 90292475
Respiratory rate increased 29.78 14.78 11 335937 15990 90276509
Rheumatoid nodule 29.73 14.78 19 335929 20147 90272352
Dyspepsia 29.70 14.78 536 335412 197624 90094875
Deafness 29.58 14.78 163 335785 22351 90270148
Hyperlipidaemia 29.37 14.78 25 335923 22891 90269608
Red cell distribution width increased 29.24 14.78 5 335943 12202 90280297
Refractory anaemia with an excess of blasts 29.16 14.78 19 335929 424 90292075
Adrenal insufficiency 29.12 14.78 41 335907 29880 90262619
Chondrocalcinosis pyrophosphate 29.01 14.78 27 335921 1031 90291468
Torsade de pointes 29.00 14.78 10 335938 15172 90277327
Anhedonia 28.94 14.78 4 335944 11427 90281072
Colitis 28.94 14.78 391 335557 69551 90222948
Onychoclasis 28.89 14.78 76 335872 7323 90285176
Hypoaesthesia oral 28.42 14.78 124 335824 15476 90277023
Pancreatitis acute 28.37 14.78 47 335901 32068 90260431
Maternal exposure before pregnancy 28.20 14.78 4 335944 11209 90281290
Product dispensing issue 28.14 14.78 19 335929 451 90292048
Salmonellosis 27.96 14.78 29 335919 1266 90291233
White blood cell count increased 27.94 14.78 141 335807 67100 90225399
Hypothyroidism 27.84 14.78 102 335846 53025 90239474
Sinus tachycardia 27.82 14.78 39 335909 28474 90264025
Eye injury 27.56 14.78 4 335944 11016 90281483
Metastases to lymph nodes 27.54 14.78 5 335943 11684 90280815
Hysterectomy 27.19 14.78 5 335943 11579 90280920
Joint effusion 27.16 14.78 20 335928 19690 90272809
Blood loss anaemia 27.01 14.78 3 335945 10137 90282362
Coagulopathy 26.81 14.78 28 335920 23261 90269238
Food allergy 26.75 14.78 33 335915 25445 90267054
Superficial spreading melanoma stage unspecified 26.69 14.78 13 335935 161 90292338
Somnolence 26.39 14.78 582 335366 208502 90083997
Campylobacter gastroenteritis 26.37 14.78 23 335925 806 90291693
N-terminal prohormone brain natriuretic peptide decreased 26.32 14.78 8 335940 22 90292477
Product physical issue 26.16 14.78 62 335886 5598 90286901
Neoplasm skin 26.13 14.78 44 335904 3098 90289401
Hypertransaminasaemia 26.08 14.78 13 335935 15812 90276687
Musculoskeletal chest pain 26.07 14.78 164 335784 23586 90268913
Hair growth abnormal 26.07 14.78 48 335900 3628 90288871
POEMS syndrome 26.06 14.78 8 335940 23 90292476
Oesophageal squamous cell carcinoma 25.97 14.78 12 335936 131 90292368
Cholecystitis chronic 25.94 14.78 3 335945 9823 90282676
Feeding disorder 25.90 14.78 131 335817 17381 90275118
Plasma cells increased 25.75 14.78 11 335937 98 90292401
Haematemesis 25.69 14.78 54 335894 33672 90258827
Infusion site swelling 25.57 14.78 6 335942 11714 90280785
Decubitus ulcer 25.55 14.78 99 335849 11714 90280785
Haemorrhoidal haemorrhage 25.36 14.78 59 335889 5264 90287235
Metastases to central nervous system 25.22 14.78 17 335931 17525 90274974
Urinary retention 25.09 14.78 65 335883 37679 90254820
Renal amyloidosis 25.00 14.78 15 335933 288 90292211
Lacrimation increased 24.98 14.78 179 335769 26883 90265616
Rectal adenocarcinoma 24.96 14.78 21 335927 700 90291799
Epistaxis 24.94 14.78 449 335499 84676 90207823
Light chain disease 24.91 14.78 11 335937 107 90292392
Breast cancer female 24.88 14.78 12 335936 14874 90277625
Chalazion 24.79 14.78 19 335929 553 90291946
Miosis 24.77 14.78 3 335945 9481 90283018
Head injury 24.69 14.78 199 335749 30989 90261510
Hypotonia 24.63 14.78 6 335942 11420 90281079
Ear pain 24.55 14.78 120 335828 57582 90234917
Insomnia 24.54 14.78 1490 334458 331984 89960515
Subretinal haematoma 24.53 14.78 9 335939 51 90292448
Encephalopathy 24.45 14.78 89 335859 46355 90246144
Sarcoidosis 24.22 14.78 5 335943 10668 90281831
Injection site discolouration 24.22 14.78 3 335945 9317 90283182
Gastroenteritis viral 24.21 14.78 194 335754 30161 90262338
Upper gastrointestinal haemorrhage 23.87 14.78 30 335918 22946 90269553
Blood urea increased 23.76 14.78 48 335900 30365 90262134
Diffuse large B-cell lymphoma recurrent 23.71 14.78 45 335903 3481 90289018
Transplant 23.57 14.78 24 335924 1025 90291474
Shock haemorrhagic 23.51 14.78 8 335940 12237 90280262
Deformity 23.28 14.78 8 335940 12162 90280337
Creatinine renal clearance abnormal 23.21 14.78 17 335931 461 90292038
Diabetes mellitus inadequate control 23.20 14.78 21 335927 18663 90273836
Hepatic encephalopathy 23.17 14.78 11 335937 13761 90278738
Malignant melanoma in situ 23.16 14.78 23 335925 953 90291546
Musculoskeletal disorder 23.08 14.78 149 335799 21620 90270879
Cardiac failure 23.03 14.78 550 335398 108946 90183553
Spondylitis 22.84 14.78 12 335936 14166 90278333
Diarrhoea haemorrhagic 22.77 14.78 89 335859 10574 90281925
Cough 22.74 14.78 1624 334324 367338 89925161
Accidental overdose 22.62 14.78 44 335904 28229 90264270
Neurologic neglect syndrome 22.62 14.78 3 335945 8844 90283655
Hypersomnia 22.60 14.78 147 335801 21384 90271115
Proteinuria 22.58 14.78 32 335916 23259 90269240
Melaena 22.32 14.78 61 335887 34736 90257763
Peripheral sensory neuropathy 22.07 14.78 80 335868 9170 90283329
Ovarian cyst 22.07 14.78 19 335929 17299 90275200
Scar 22.03 14.78 15 335933 15380 90277119
Cholecystectomy 22.02 14.78 8 335940 11747 90280752
Mass 21.98 14.78 115 335833 15462 90277037
Haemoglobin abnormal 21.93 14.78 67 335881 7033 90285466
Electrolyte imbalance 21.88 14.78 157 335791 23588 90268911
Spinal cord compression 21.84 14.78 53 335895 4858 90287641
Skin fissures 21.80 14.78 27 335921 20782 90271717
Lumbar vertebral fracture 21.76 14.78 69 335879 7389 90285110
Vertebral lesion 21.75 14.78 20 335928 752 90291747
Colitis ischaemic 21.63 14.78 97 335851 12249 90280250
Pre-eclampsia 21.59 14.78 7 335941 11041 90281458
Hyperproteinaemia 21.59 14.78 11 335937 151 90292348
Clavicle fracture 21.57 14.78 46 335902 3870 90288629
Neck pain 21.54 14.78 295 335653 113668 90178831
Respiratory tract infection 21.53 14.78 323 335625 58755 90233744
Pulmonary hypertension 21.40 14.78 83 335865 42440 90250059
Febrile neutropenia 21.33 14.78 752 335196 157597 90134902
Hypoxia 21.23 14.78 169 335779 72230 90220269
Limb discomfort 21.11 14.78 225 335723 37835 90254664
Gastric infection 21.07 14.78 46 335902 3934 90288565
Malignant neoplasm progression 21.04 14.78 532 335416 106338 90186161
Vascular device infection 20.96 14.78 9 335939 11943 90280556
Spinal osteoarthritis 20.96 14.78 24 335924 19124 90273375
International normalised ratio increased 20.95 14.78 97 335851 47219 90245280
Cytogenetic abnormality 20.88 14.78 17 335931 541 90291958
Photophobia 20.84 14.78 29 335919 21240 90271259
Spinal operation 20.75 14.78 6 335942 10190 90282309
Post procedural complication 20.70 14.78 24 335924 19018 90273481
Gangrene 20.59 14.78 11 335937 12865 90279634
Pneumonia legionella 20.56 14.78 30 335918 1867 90290632
Dyslipidaemia 20.48 14.78 6 335942 10101 90282398
Altered state of consciousness 20.43 14.78 55 335893 31477 90261022
Oral infection 20.38 14.78 54 335894 5226 90287273
Shock 20.35 14.78 48 335900 28730 90263769
Cerebellar haemangioma 20.34 14.78 9 335939 88 90292411
Cystitis 20.29 14.78 354 335594 66364 90226135
Blood test 20.15 14.78 6 335942 15 90292484
Gingival swelling 20.09 14.78 52 335896 4961 90287538
Ear discomfort 20.07 14.78 83 335865 10117 90282382
Movement disorder 20.05 14.78 49 335899 28970 90263529
Muscle twitching 19.95 14.78 37 335911 24165 90268334
Glycosylated haemoglobin increased 19.92 14.78 17 335931 15545 90276954
Nasal abscess 19.88 14.78 11 335937 180 90292319
Hallucination, auditory 19.79 14.78 18 335930 15957 90276542
Circulatory collapse 19.72 14.78 39 335909 24865 90267634
Ventricular fibrillation 19.68 14.78 14 335934 14030 90278469
Exposure to toxic agent 19.67 14.78 3 335945 7964 90284535
Tuberculosis 19.66 14.78 11 335937 12538 90279961
Cushingoid 19.60 14.78 7 335941 10388 90282111
Pulmonary sepsis 19.57 14.78 32 335916 2199 90290300
Tardive dyskinesia 19.54 14.78 8 335940 10922 90281577
Limb injury 19.26 14.78 190 335758 31318 90261181
Aspiration bone marrow 19.26 14.78 11 335937 192 90292307
Monocyte count increased 19.18 14.78 5 335943 9092 90283407
Blood sodium decreased 19.12 14.78 171 335777 27442 90265057
Wheelchair user 19.07 14.78 3 335945 7782 90284717
Infection in an immunocompromised host 19.04 14.78 20 335928 886 90291613
Product substitution issue 18.93 14.78 123 335825 17885 90274614
Nasopharyngitis 18.82 14.78 1753 334195 405351 89887148
Bowel movement irregularity 18.76 14.78 60 335888 6454 90286045
Rectal haemorrhage 18.74 14.78 206 335742 82538 90209961
Bone density decreased 18.70 14.78 22 335926 17323 90275176
Pneumonia aspiration 18.68 14.78 83 335865 40857 90251642
Human chorionic gonadotropin positive 18.61 14.78 7 335941 43 90292456
Body dysmorphic disorder 18.58 14.78 14 335934 397 90292102
Cervical vertebral fracture 18.51 14.78 39 335909 3254 90289245
Anosmia 18.50 14.78 79 335869 9769 90282730
Aggression 18.45 14.78 45 335903 26623 90265876
Skin plaque 18.33 14.78 7 335941 9968 90282531
Hypersensitivity myocarditis 18.18 14.78 12 335936 274 90292225
Cholestasis 18.17 14.78 71 335877 36228 90256271
Immunoglobulins increased 18.12 14.78 16 335932 570 90291929
Product administration interrupted 18.10 14.78 12 335936 12480 90280019
Escherichia sepsis 18.07 14.78 55 335893 5761 90286738
Hernia 18.01 14.78 102 335846 14129 90278370
Arterial occlusive disease 17.98 14.78 12 335936 12434 90280065
Adenocarcinoma pancreas 17.97 14.78 22 335926 1154 90291345
Target skin lesion 17.96 14.78 9 335939 119 90292380
Low density lipoprotein increased 17.92 14.78 4 335944 8081 90284418
Blood pressure systolic decreased 17.89 14.78 6 335942 9264 90283235
Light chain analysis decreased 17.89 14.78 5 335943 9 90292490
Varicophlebitis 17.85 14.78 6 335942 25 90292474
Respiratory distress 17.74 14.78 79 335869 38867 90253632
Gastrointestinal fungal infection 17.67 14.78 14 335934 428 90292071
Swollen tongue 17.63 14.78 99 335849 45857 90246642
Left ventricular dysfunction 17.61 14.78 17 335931 14652 90277847
Speech disorder 17.60 14.78 98 335850 45487 90247012
Blood bilirubin increased 17.58 14.78 92 335856 43378 90249121
Neurotoxicity 17.53 14.78 33 335915 21434 90271065
Sickle cell anaemia with crisis 17.45 14.78 3 335945 7294 90285205
Rash maculo-papular 17.41 14.78 230 335718 40703 90251796
Middle ear effusion 17.40 14.78 34 335914 2687 90289812
Body temperature increased 17.32 14.78 96 335852 44614 90247885
Colitis microscopic 17.17 14.78 10 335938 11149 90281350
Pemphigoid 17.15 14.78 6 335942 9020 90283479
Hallucination 17.09 14.78 159 335789 65800 90226699
Panic attack 17.07 14.78 46 335902 26319 90266180
Blood iron increased 17.05 14.78 28 335920 1931 90290568
Toxic neuropathy 17.02 14.78 15 335933 533 90291966
Fistula 17.00 14.78 12 335936 12077 90280422
Foreign body in respiratory tract 16.96 14.78 12 335936 308 90292191
Invasive lobular breast carcinoma 16.95 14.78 20 335928 1009 90291490
Immunosuppression 16.93 14.78 89 335859 11988 90280511
Myelosuppression 16.89 14.78 286 335662 53305 90239194
Syncope 16.88 14.78 626 335322 132037 90160462
Ventricular tachycardia 16.85 14.78 42 335906 24666 90267833
Endocarditis bacterial 16.81 14.78 16 335932 629 90291870
Liver function test abnormal 16.67 14.78 115 335833 50730 90241769
Delusion 16.66 14.78 16 335932 13824 90278675
Oral mucosal blistering 16.62 14.78 60 335888 6864 90285635
Gastroenteritis salmonella 16.52 14.78 18 335930 832 90291667
Cardiac valve disease 16.48 14.78 46 335902 4589 90287910
Unintended pregnancy 16.48 14.78 4 335944 7633 90284866
Blood triglycerides increased 16.46 14.78 16 335932 13745 90278754
Post procedural haemorrhage 16.46 14.78 6 335942 8792 90283707
Clostridial sepsis 16.45 14.78 15 335933 558 90291941
Blood lactic acid increased 16.40 14.78 6 335942 8772 90283727
Sensory loss 16.39 14.78 26 335922 18049 90274450
Skin disorder 16.35 14.78 208 335740 36498 90256001
Spondylolysis 16.34 14.78 9 335939 146 90292353
Infusion site extravasation 16.26 14.78 9 335939 10319 90282180
Expired product administered 16.22 14.78 3 335945 6919 90285580
Miliary pneumonia 16.21 14.78 6 335942 35 90292464
Genital haemorrhage 16.17 14.78 6 335942 8696 90283803
Respiratory acidosis 16.12 14.78 5 335943 8114 90284385
Intermenstrual bleeding 16.09 14.78 7 335941 9216 90283283
Toothache 16.08 14.78 139 335809 22091 90270408
Bone marrow myelogram abnormal 16.07 14.78 6 335942 36 90292463
Furuncle 16.06 14.78 63 335885 7498 90285001
Fluid retention 16.03 14.78 434 335514 87657 90204842
Jaundice 16.03 14.78 64 335884 32453 90260046
Exfoliative rash 15.89 14.78 36 335912 3156 90289343
Oral herpes 15.88 14.78 67 335881 33457 90259042
Intracranial pressure increased 15.86 14.78 3 335945 6808 90285691
Tongue discomfort 15.84 14.78 33 335915 2732 90289767
Anuria 15.76 14.78 19 335929 14799 90277700
Meningitis aseptic 15.73 14.78 3 335945 6770 90285729
Haemorrhage 15.68 14.78 352 335596 69017 90223482
Lipase increased 15.67 14.78 11 335937 11100 90281399
Neoplasm 15.64 14.78 70 335878 8833 90283666
Cardiogenic shock 15.61 14.78 43 335905 24425 90268074
Aphasia 15.48 14.78 94 335854 42718 90249781
Major depression 15.43 14.78 9 335939 10026 90282473
Diarrhoea infectious 15.38 14.78 21 335927 1228 90291271
Morganella infection 15.37 14.78 17 335931 799 90291700
Red blood cell abnormality 15.30 14.78 14 335934 523 90291976
Marasmus 15.25 14.78 17 335931 806 90291693
Oropharyngeal pain 15.25 14.78 546 335402 114641 90177858
Squamous cell carcinoma 15.25 14.78 76 335872 10025 90282474
Pneumonia streptococcal 15.24 14.78 28 335920 2113 90290386
Respiratory disorder 15.22 14.78 160 335788 64656 90227843
Nystagmus 15.18 14.78 4 335944 7223 90285276
Apnoea 15.11 14.78 8 335940 9406 90283093
Tubulointerstitial nephritis 15.10 14.78 46 335902 25297 90267202
Humerus fracture 15.04 14.78 74 335874 9711 90282788
Crepitations 15 14.78 7 335941 8845 90283654
Stomach mass 14.95 14.78 12 335936 374 90292125
Angina unstable 14.92 14.78 4 335944 7139 90285360
Thyroid disorder 14.92 14.78 115 335833 17670 90274829
Hepatocellular injury 14.91 14.78 56 335892 28902 90263597
Visceral leishmaniasis 14.86 14.78 15 335933 634 90291865
Skin haemorrhage 14.85 14.78 36 335912 21344 90271155
Protothecosis 14.85 14.78 13 335935 458 90292041
Coronary artery disease 14.84 14.78 69 335879 33554 90258945
Psychiatric symptom 14.84 14.78 4 335944 7114 90285385
Nodule 14.81 14.78 50 335898 26636 90265863
Asphyxia 14.79 14.78 4 335944 7099 90285400

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
Death 6454.99 14.73 12358 318758 458827 41831392
Full blood count decreased 5118.06 14.73 2705 328411 17855 42272364
Neuropathy peripheral 3929.16 14.73 4382 326734 97471 42192748
Rash 3692.10 14.73 7204 323912 269750 42020469
White blood cell count decreased 3584.56 14.73 4347 326769 106049 42184170
Pneumonia 3154.20 14.73 8742 322374 413407 41876812
Thrombosis 3117.49 14.73 3219 327897 65292 42224927
Fatigue 3057.92 14.73 8820 322296 426821 41863398
Platelet count decreased 2622.49 14.73 4210 326906 134371 42155848
Laboratory test abnormal 2597.83 14.73 1824 329292 21154 42269065
Diarrhoea 2311.26 14.73 8321 322795 452528 41837691
Unevaluable event 1753.93 14.73 1718 329398 32570 42257649
Drug interaction 1632.45 14.73 115 331001 266884 42023335
Plasma cell myeloma 1591.92 14.73 1905 329211 45673 42244546
Adverse drug reaction 1549.68 14.73 1674 329442 35760 42254459
Muscle spasms 1439.55 14.73 2476 328640 83568 42206651
Constipation 1410.43 14.73 3566 327550 158725 42131494
Plasma cell myeloma recurrent 1240.57 14.73 689 330427 5068 42285151
Deep vein thrombosis 1205.79 14.73 2152 328964 74805 42215414
Neutropenia 990.92 14.73 3600 327516 195831 42094388
Condition aggravated 959.92 14.73 413 330703 260341 42029878
Peripheral swelling 861.66 14.73 2058 329058 88212 42202007
Drug abuse 784.47 14.73 5 331111 104766 42185453
Tooth disorder 781.96 14.73 688 330428 11291 42278928
Cardiac disorder 767.99 14.73 1370 329746 47562 42242657
COVID-19 756.96 14.73 2297 328819 113651 42176568
Product use in unapproved indication 746.86 14.73 251 330865 184205 42106014
Drug ineffective 698.86 14.73 2538 328578 627659 41662560
Product dose omission issue 672.80 14.73 2674 328442 151691 42138528
Renal disorder 596.69 14.73 917 330199 28063 42262156
Completed suicide 595.91 14.73 39 331077 96426 42193793
Overdose 591.58 14.73 64 331052 105200 42185019
Rash pruritic 566.32 14.73 971 330145 32632 42257587
Ageusia 558.76 14.73 563 330553 11042 42279177
Pulmonary thrombosis 553.94 14.73 484 330632 7864 42282355
Red blood cell count decreased 548.26 14.73 943 330173 31772 42258447
Influenza 464.17 14.73 1293 329823 60882 42229337
Plasmacytoma 457.26 14.73 331 330785 4033 42286186
Asthenia 449.49 14.73 3718 327398 277075 42013144
Squamous cell carcinoma of skin 439.05 14.73 518 330598 12208 42278011
Pancytopenia 437.12 14.73 1943 329173 115800 42174419
Adverse event 436.85 14.73 712 330404 22928 42267291
Thrombocytopenia 435.89 14.73 2747 328369 187532 42102687
Intentional product misuse 407.39 14.73 17 331099 61883 42228336
Injection site pain 390.26 14.73 13 331103 57785 42232434
Myelodysplastic syndrome 386.79 14.73 660 330456 22085 42268134
Cytopenia 386.18 14.73 572 330544 16925 42273294
Neutrophil count decreased 384.30 14.73 1225 329891 62190 42228029
Intentional overdose 382.31 14.73 3 331113 51453 42238766
Acute kidney injury 375.82 14.73 1525 329591 365812 41924407
Rhabdomyolysis 364.53 14.73 80 331036 77939 42212280
Pulmonary embolism 357.16 14.73 1854 329262 117758 42172461
Foetal exposure during pregnancy 350.33 14.73 3 331113 47308 42242911
Infection 349.19 14.73 1758 329358 110310 42179909
Tachycardia 334.86 14.73 184 330932 100903 42189316
Aspartate aminotransferase increased 331.69 14.73 94 331022 77069 42213150
Alanine aminotransferase increased 326.20 14.73 139 330977 88267 42201952
Inappropriate schedule of product administration 319.93 14.73 173 330943 95729 42194490
Hip fracture 312.64 14.73 451 330665 13021 42277198
Back disorder 312.32 14.73 337 330779 7177 42283042
Nasopharyngitis 309.92 14.73 1384 329732 82612 42207607
Hyponatraemia 306.31 14.73 206 330910 101256 42188963
Haemoglobin decreased 302.67 14.73 1912 329204 130559 42159660
Suicide attempt 302.21 14.73 13 331103 46087 42244132
Light chain analysis increased 300.32 14.73 183 330933 1631 42288588
Abdominal pain 300.20 14.73 645 330471 189826 42100393
Acute myeloid leukaemia 291.50 14.73 577 330539 21679 42268540
Cataract 285.36 14.73 692 330424 29912 42260307
Vomiting 282.17 14.73 1225 329891 288498 42001721
Herpes zoster 277.79 14.73 796 330320 38081 42252138
Hypertension 277.15 14.73 550 330566 166654 42123565
Drug intolerance 275.06 14.73 1296 329820 79128 42211091
Gallbladder disorder 273.30 14.73 310 330806 6992 42283227
Hypoaesthesia 273.06 14.73 1190 329926 70273 42219946
Rheumatoid arthritis 271.63 14.73 14 331102 42426 42247793
Acute lymphocytic leukaemia 271.06 14.73 220 330896 3211 42287008
Hyperkalaemia 270.01 14.73 144 330972 80314 42209905
Taste disorder 267.10 14.73 362 330754 9845 42280374
Full blood count abnormal 265.27 14.73 663 330453 29213 42261006
Blood creatine phosphokinase increased 264.90 14.73 32 331084 48306 42241913
Body height decreased 264.56 14.73 234 330882 3866 42286353
Wrong technique in product usage process 263.89 14.73 17 331099 42618 42247601
B-cell type acute leukaemia 258.22 14.73 126 330990 682 42289537
Coma 251.99 14.73 54 331062 53500 42236719
Bradycardia 250.78 14.73 179 330937 85305 42204914
Hypoglycaemia 242.66 14.73 81 331035 59773 42230446
Full blood count increased 242.60 14.73 130 330986 882 42289337
Blood potassium decreased 241.51 14.73 507 330609 19877 42270342
Plasma cell myeloma refractory 240.52 14.73 145 330971 1265 42288954
Hiccups 240.48 14.73 378 330738 11793 42278426
Protein total increased 230.93 14.73 178 330938 2400 42287819
Suicidal ideation 229.81 14.73 47 331069 48114 42242105
Metabolic acidosis 228.80 14.73 60 331056 51798 42238421
Depressed level of consciousness 226.45 14.73 48 331068 47922 42242297
Headache 222.71 14.73 1029 330087 238340 42051879
Lactic acidosis 222.66 14.73 41 331075 45220 42244999
Seasonal allergy 218.90 14.73 291 330825 7764 42282455
Incorrect dose administered 214.20 14.73 72 331044 52902 42237317
Blood pressure increased 212.95 14.73 288 330828 101640 42188579
Therapeutic product effect incomplete 212.76 14.73 145 330971 70794 42219425
Ascites 212.43 14.73 87 331029 56591 42233628
Monoclonal immunoglobulin present 211.82 14.73 126 330990 1070 42289149
Gastric disorder 209.35 14.73 351 330765 11571 42278648
Pruritus 207.62 14.73 2311 328805 186460 42103759
Spinal fracture 206.46 14.73 303 330813 8887 42281332
Blood test abnormal 205.69 14.73 364 330752 12542 42277677
Renal failure 202.51 14.73 1852 329264 141874 42148345
Sedation 201.73 14.73 8 331108 30467 42259752
Agitation 198.90 14.73 127 330989 64187 42226032
Seizure 198.44 14.73 398 330718 120163 42170056
Bronchitis 198.13 14.73 809 330307 46392 42243827
Wheezing 197.48 14.73 89 331027 54692 42235527
Therapy interrupted 193.56 14.73 490 330626 21760 42268459
Aggression 191.23 14.73 53 331063 44110 42246109
Electrocardiogram QT prolonged 188.97 14.73 68 331048 47877 42242342
Oxygen saturation decreased 187.68 14.73 137 330979 64550 42225669
Serotonin syndrome 185.23 14.73 3 331113 25842 42264377
Plasma cell leukaemia 184.79 14.73 117 330999 1123 42289096
Asthma 179.46 14.73 133 330983 62181 42228038
Drug level increased 176.46 14.73 6 331110 26194 42264025
Psoriatic arthropathy 174.49 14.73 4 331112 24963 42265256
Basal cell carcinoma 173.68 14.73 477 330639 22256 42267963
Obstructive airways disorder 172.91 14.73 4 331112 24755 42265464
Psoriasis 172.04 14.73 81 331035 48523 42241696
Loss of personal independence in daily activities 171.79 14.73 86 331030 49730 42240489
Interstitial lung disease 171.79 14.73 214 330902 78248 42211971
C-reactive protein increased 171.29 14.73 145 330971 63415 42226804
Anaphylactic reaction 171.24 14.73 59 331057 42684 42247535
Skin cancer 170.84 14.73 314 330802 11148 42279071
Medication error 169.75 14.73 27 331089 33127 42257092
Drug-induced liver injury 169.36 14.73 44 331072 38229 42251990
Back pain 166.07 14.73 1758 329358 140018 42150201
Contraindicated product administered 166.05 14.73 7 331109 25265 42264954
Arthropathy 165.92 14.73 557 330559 29040 42261179
Stress 160.66 14.73 71 331045 44141 42246078
Multiple allergies 159.86 14.73 170 330946 3558 42286661
Hernia 159.59 14.73 299 330817 10774 42279445
Drug ineffective for unapproved indication 157.23 14.73 81 331035 46082 42244137
Incorrect route of product administration 155.58 14.73 8 331108 24297 42265922
Premature baby 153.51 14.73 6 331110 23147 42267072
Blood pressure systolic increased 152.04 14.73 19 331097 27949 42262270
Disease progression 150.71 14.73 1743 329373 141913 42148306
Fall 150.32 14.73 2608 328508 231912 42058307
Product distribution issue 147.36 14.73 123 330993 1871 42288348
Somnolence 144.86 14.73 584 330532 140521 42149698
Dehydration 144.68 14.73 1711 329405 140056 42150163
Bone pain 144.36 14.73 460 330656 23332 42266887
Generalised tonic-clonic seizure 143.20 14.73 18 331098 26361 42263858
Skin discolouration 142.71 14.73 421 330695 20469 42269750
Lactose intolerance 141.53 14.73 107 331009 1399 42288820
Spinal disorder 140.64 14.73 176 330940 4415 42285804
Anxiety 138.56 14.73 465 330651 118095 42172124
General physical health deterioration 138.22 14.73 654 330462 150592 42139627
Angioedema 138.15 14.73 79 331037 42398 42247821
Colitis ulcerative 137.02 14.73 20 331096 26155 42264064
Drug hypersensitivity 133.15 14.73 366 330750 99023 42191196
Product use issue 131.77 14.73 247 330869 76504 42213715
Haematuria 131.43 14.73 153 330963 57646 42232573
Tubulointerstitial nephritis 130.84 14.73 41 331075 31507 42258712
Ventricular fibrillation 130.69 14.73 36 331080 30087 42260132
Melaena 130.45 14.73 69 331047 38677 42251542
Localised infection 130.15 14.73 401 330715 19972 42270247
Pallor 130.14 14.73 32 331084 28854 42261365
Transaminases increased 128.97 14.73 47 331069 32838 42257381
Hypoxia 127.54 14.73 216 330900 69570 42220649
Anaphylactic shock 125.37 14.73 17 331099 23500 42266719
Gamma-glutamyltransferase increased 124.84 14.73 48 331068 32449 42257770
Depression 124.57 14.73 445 330671 110918 42179301
Multiple organ dysfunction syndrome 124.34 14.73 365 330751 96670 42193549
Cholestasis 122.33 14.73 51 331065 32828 42257391
Illness 122.31 14.73 449 330667 24481 42265738
Swelling face 121.78 14.73 480 330636 27074 42263145
Hypercalcaemia 120.57 14.73 361 330755 17697 42272522
Hallucination, visual 120.01 14.73 12 331104 21008 42269211
Dysarthria 119.81 14.73 81 331035 39726 42250493
Pathological fracture 119.60 14.73 175 330941 5118 42285101
Respiratory depression 118.32 14.73 7 331109 18861 42271358
Dry skin 117.92 14.73 710 330406 47628 42242591
Atrial fibrillation 117.90 14.73 1627 329489 137966 42152253
Product prescribing error 117.49 14.73 29 331087 26083 42264136
Cardio-respiratory arrest 117.11 14.73 171 330945 58465 42231754
Immune system disorder 115.65 14.73 185 330931 5859 42284360
International normalised ratio increased 115.57 14.73 122 330994 48046 42242173
Tumour flare 115.23 14.73 85 331031 1068 42289151
Cardiogenic shock 114.88 14.73 67 331049 35573 42254646
Injection site swelling 113.90 14.73 4 331112 16969 42273250
Bone disorder 113.85 14.73 193 330923 6420 42283799
Accidental overdose 113.65 14.73 39 331077 28291 42261928
Extrapyramidal disorder 113.28 14.73 3 331113 16409 42273810
Mucosal inflammation 113.01 14.73 130 330986 49244 42240975
Malignant melanoma 112.73 14.73 235 330881 9165 42281054
Psychotic disorder 112.44 14.73 43 331073 29165 42261054
Myoclonus 111.21 14.73 5 331111 17060 42273159
Hepatic function abnormal 110.40 14.73 143 330973 51424 42238795
Abnormal behaviour 110.37 14.73 34 331082 26417 42263802
Upper limb fracture 110.37 14.73 173 330943 5383 42284836
Upper gastrointestinal haemorrhage 109.54 14.73 49 331067 30250 42259969
Myelodysplastic syndrome transformation 108.86 14.73 61 331055 457 42289762
Blood alkaline phosphatase increased 108.52 14.73 63 331053 33534 42256685
Diabetic ketoacidosis 108.42 14.73 21 331095 22346 42267873
Acute leukaemia 107.97 14.73 84 331032 1149 42289070
Osteonecrosis of jaw 107.20 14.73 359 330757 18690 42271529
Compression fracture 106.03 14.73 138 330978 3604 42286615
Arteriosclerosis coronary artery 105.75 14.73 11 331105 18666 42271553
Bone lesion 103.20 14.73 131 330985 3335 42286884
Prostatic disorder 102.90 14.73 135 330981 3554 42286665
Treatment failure 102.74 14.73 207 330909 62417 42227802
Accidental exposure to product 101.31 14.73 18 331098 20375 42269844
Myasthenia gravis 101.15 14.73 6 331110 16131 42274088
Blood urea increased 101.03 14.73 65 331051 32728 42257491
Erythema 100.77 14.73 468 330648 108325 42181894
Pancreatitis acute 100.07 14.73 69 331047 33495 42256724
Respiratory arrest 99.61 14.73 48 331068 28376 42261843
Hepatocellular injury 99.58 14.73 30 331086 23648 42266571
Gastrointestinal haemorrhage 99.27 14.73 406 330710 97320 42192899
Underdose 99.23 14.73 8 331108 16658 42273561
Drug resistance 98.71 14.73 73 331043 34175 42256044
Adenocarcinoma of colon 98.47 14.73 135 330981 3712 42286507
Rib fracture 98.35 14.73 318 330798 16253 42273966
Anaemia 98.00 14.73 2860 328256 277418 42012801
Spinal compression fracture 97.95 14.73 194 330922 7289 42282930
Leukocytosis 96.96 14.73 55 331061 29653 42260566
Palpitations 95.81 14.73 154 330962 50643 42239576
Musculoskeletal disorder 95.35 14.73 179 330937 6459 42283760
B precursor type acute leukaemia 95.24 14.73 44 331072 206 42290013
Dyskinesia 95.07 14.73 39 331077 25351 42264868
Monoclonal immunoglobulin increased 94.81 14.73 53 331063 395 42289824
Hordeolum 94.63 14.73 87 331029 1515 42288704
Status epilepticus 94.09 14.73 7 331109 15571 42274648
Sinus tachycardia 92.80 14.73 23 331093 20630 42269589
Obesity 92.40 14.73 10 331106 16449 42273770
Emotional distress 92.36 14.73 9 331107 16084 42274135
Chest discomfort 91.50 14.73 226 330890 63390 42226829
Intentional self-injury 91.34 14.73 7 331109 15195 42275024
Hallucination 91.03 14.73 194 330922 57313 42232906
Activated partial thromboplastin time prolonged 90.99 14.73 9 331107 15894 42274325
Paraesthesia 90.20 14.73 920 330196 72539 42217680
No adverse event 89.02 14.73 103 331013 38918 42251301
Decreased appetite 88.79 14.73 2044 329072 191093 42099126
Synovitis 88.57 14.73 9 331107 15558 42274661
Hypoacusis 88.54 14.73 333 330783 18369 42271850
White blood cell count abnormal 88.31 14.73 126 330990 3599 42286620
SARS-CoV-2 test positive 88.17 14.73 197 330919 8063 42282156
Delirium 87.52 14.73 172 330944 52347 42237872
Altered state of consciousness 87.43 14.73 60 331056 29199 42261020
Encephalopathy 87.06 14.73 116 331000 41217 42249002
Unresponsive to stimuli 86.61 14.73 70 331046 31333 42258886
Paranoia 85.59 14.73 6 331110 14020 42276199
Transplant rejection 85.33 14.73 5 331111 13583 42276636
Eye disorder 85.08 14.73 240 330876 11372 42278847
Gout 85.03 14.73 437 330679 27618 42262601
Joint swelling 85.00 14.73 855 330261 67167 42223052
Ventricular tachycardia 84.73 14.73 66 331050 30094 42260125
Hepatic failure 83.27 14.73 104 331012 37996 42252223
Hypomagnesaemia 83.04 14.73 60 331056 28428 42261791
Hepatic cytolysis 82.98 14.73 53 331063 26791 42263428
Blood bilirubin increased 81.67 14.73 126 330990 42126 42248093
Tachypnoea 81.55 14.73 33 331083 21629 42268590
Shock 81.46 14.73 64 331052 29057 42261162
Nightmare 80.64 14.73 47 331069 24965 42265254
Cerebrovascular accident 79.37 14.73 1126 329990 96034 42194185
Cardiac arrest 79.37 14.73 510 330606 108810 42181409
Sepsis 78.85 14.73 2067 329049 197267 42092952
Eczema 78.81 14.73 89 331027 33997 42256222
Hepatotoxicity 78.74 14.73 49 331067 25118 42265101
Dementia 78.48 14.73 294 330822 16186 42274033
Insomnia 78.45 14.73 1323 329793 116930 42173289
Circulatory collapse 78.23 14.73 43 331073 23593 42266626
Fluid retention 78.10 14.73 466 330650 31153 42259066
Blood pressure fluctuation 78.01 14.73 57 331059 26851 42263368
Withdrawal syndrome 78.00 14.73 11 331105 14764 42275455
Pregnancy of partner 77.49 14.73 46 331070 389 42289830
Hyperlipidaemia 77.46 14.73 35 331081 21481 42268738
Breath sounds abnormal 77.33 14.73 4 331112 12089 42278130
Injection site erythema 77.28 14.73 30 331086 20165 42270054
Increased tendency to bruise 77.17 14.73 129 330987 4241 42285978
Hyperhidrosis 77.09 14.73 401 330715 90111 42200108
Muscle rigidity 77.08 14.73 4 331112 12055 42278164
Hypercholesterolaemia 76.97 14.73 6 331110 12843 42277376
Pulmonary fibrosis 76.73 14.73 57 331059 26624 42263595
Product quality issue 76.40 14.73 22 331094 17860 42272359
Sinusitis 76.17 14.73 628 330488 46664 42243555
Hypophosphataemia 75.51 14.73 34 331082 20911 42269308
Bronchiectasis 75.47 14.73 23 331093 17996 42272223
Hypokalaemia 75.33 14.73 294 330822 71427 42218792
Epilepsy 75.14 14.73 56 331060 26115 42264104
Blood phosphorus increased 74.60 14.73 6 331110 12519 42277700
Impaired work ability 74.28 14.73 5 331111 12086 42278133
Myositis 74.11 14.73 13 331103 14853 42275366
Agranulocytosis 74.02 14.73 77 331039 30535 42259684
Hepatic steatosis 73.97 14.73 37 331079 21411 42268808
Brain oedema 73.71 14.73 18 331098 16309 42273910
Haematochezia 73.25 14.73 222 330894 58214 42232005
Cyanosis 73.09 14.73 14 331102 15017 42275202
Rectal haemorrhage 73.09 14.73 174 330942 49432 42240787
Hyperphosphataemia 72.75 14.73 8 331108 12996 42277223
Cerebral infarction 72.48 14.73 81 331035 31088 42259131
Gastrointestinal disorder 72.20 14.73 614 330502 46039 42244180
Dysgeusia 72.11 14.73 484 330632 33705 42256514
Haematemesis 71.86 14.73 77 331039 30122 42260097
Neutrophil count increased 71.63 14.73 32 331084 19772 42270447
Restlessness 71.37 14.73 73 331043 29176 42261043
Inappropriate antidiuretic hormone secretion 71.32 14.73 20 331096 16521 42273698
Pancreatitis 70.98 14.73 143 330973 43125 42247094
Malignant neoplasm of unknown primary site 70.96 14.73 43 331073 379 42289840
Osteolysis 70.45 14.73 111 331005 3469 42286750
Treatment delayed 69.74 14.73 32 331084 147 42290072
Mobility decreased 69.47 14.73 104 331012 35202 42255017
Coronavirus infection 69.24 14.73 136 330980 5078 42285141
Hepatitis 69.08 14.73 66 331050 27234 42262985
Delusion 69.00 14.73 15 331101 14719 42275500
Fear 68.96 14.73 4 331112 10961 42279258
Feeling abnormal 68.77 14.73 837 330279 68949 42221270
Haemoptysis 67.97 14.73 162 330954 46005 42244214
Hallucination, auditory 67.87 14.73 16 331100 14848 42275371
Nerve injury 67.62 14.73 115 331001 3835 42286384
Blood calcium decreased 67.59 14.73 215 330901 10893 42279326
White blood cell disorder 67.58 14.73 79 331037 1842 42288377
Sinus disorder 66.61 14.73 174 330942 7876 42282343
Dystonia 66.41 14.73 10 331106 12780 42277439
Coronary artery disease 65.97 14.73 206 330910 53514 42236705
Hypothyroidism 65.60 14.73 92 331024 31992 42258227
Hepatic encephalopathy 65.32 14.73 23 331093 16419 42273800
Vitamin B12 decreased 64.79 14.73 72 331044 1586 42288633
Injection site bruising 64.70 14.73 7 331109 11518 42278701
Hemiparesis 64.56 14.73 27 331089 17349 42272870
Pathogen resistance 64.17 14.73 7 331109 11443 42278776
Shock haemorrhagic 64.05 14.73 23 331093 16219 42274000
COVID-19 pneumonia 63.65 14.73 334 330782 21279 42268940
Sleep apnoea syndrome 63.65 14.73 45 331071 21563 42268656
Blood triglycerides increased 63.56 14.73 22 331094 15874 42274345
Device malfunction 63.18 14.73 10 331106 12317 42277902
Body temperature decreased 62.94 14.73 17 331099 14396 42275823
Toxic epidermal necrolysis 62.77 14.73 69 331047 26681 42263538
Haemodynamic instability 62.56 14.73 11 331105 12546 42277673
Depressed mood 62.18 14.73 54 331062 23330 42266889
Disseminated intravascular coagulation 61.51 14.73 61 331055 24733 42265486
Light chain analysis abnormal 61.48 14.73 28 331088 126 42290093
Renal impairment 61.41 14.73 1200 329916 109028 42181191
Jaundice 61.40 14.73 109 331007 34480 42255739
Cardiac failure congestive 61.31 14.73 970 330146 84632 42205587
Urinary tract infection 61.23 14.73 1098 330018 98186 42192033
Memory impairment 61.16 14.73 628 330488 49594 42240625
Leukaemia 60.86 14.73 137 330979 5635 42284584
Gynaecomastia 60.49 14.73 12 331104 12555 42277664
White blood cell count increased 60.37 14.73 166 330950 44921 42245298
Immune reconstitution inflammatory syndrome 60.02 14.73 5 331111 10138 42280081
Product administration error 59.80 14.73 34 331082 18309 42271910
Respiratory distress 59.79 14.73 149 330967 41671 42248548
Infusion related reaction 59.02 14.73 257 330859 60549 42229670
Proteinuria 58.81 14.73 55 331061 22928 42267291
Venoocclusive liver disease 58.50 14.73 6 331110 10296 42279923
Cytomegalovirus infection 58.08 14.73 101 331015 32205 42258014
Coagulopathy 57.94 14.73 52 331064 22110 42268109
Respiratory failure 57.60 14.73 677 330439 127455 42162764
Aplastic anaemia 57.20 14.73 13 331103 12371 42277848
Injection site haemorrhage 56.92 14.73 11 331105 11725 42278494
Prescribed overdose 56.92 14.73 15 331101 12912 42277307
Hyperbilirubinaemia 56.90 14.73 46 331070 20589 42269630
Flushing 56.05 14.73 128 330988 36900 42253319
Dizziness 56.04 14.73 2419 328697 246835 42043384
Toxicity to various agents 55.64 14.73 1355 329761 227781 42062438
Surgery 55.52 14.73 34 331082 17582 42272637
Neurotoxicity 55.50 14.73 61 331055 23590 42266629
Productive cough 55.03 14.73 210 330906 51357 42238862
Confusional state 55.00 14.73 943 330173 166654 42123565
Dyslipidaemia 54.76 14.73 5 331111 9413 42280806
Pneumonia aspiration 54.70 14.73 202 330914 49876 42240343
Inflammation 54.55 14.73 113 331003 33734 42256485
Acidosis 54.54 14.73 14 331102 12265 42277954
Injection site reaction 54.40 14.73 27 331089 15694 42274525
Posterior reversible encephalopathy syndrome 54.36 14.73 16 331100 12805 42277414
Impaired quality of life 54.35 14.73 21 331095 14156 42276063
Arthralgia 54.21 14.73 1198 329918 204040 42086179
Diabetes mellitus inadequate control 53.91 14.73 26 331090 15364 42274855
Metastases to bone 53.45 14.73 24 331092 14785 42275434
Lipase increased 53.20 14.73 9 331107 10557 42279662
Protein total abnormal 52.47 14.73 35 331081 370 42289849
Blood immunoglobulin G increased 52.40 14.73 54 331062 1088 42289131
Therapy change 52.20 14.73 105 331011 3990 42286229
Hypogeusia 52.07 14.73 53 331063 1052 42289167
Febrile neutropenia 51.94 14.73 1074 330042 184629 42105590
Torsade de pointes 51.51 14.73 4 331112 8590 42281629
Systemic lupus erythematosus 51.50 14.73 6 331110 9318 42280901
Tooth infection 51.45 14.73 158 330958 7853 42282366
Uveitis 51.03 14.73 6 331110 9252 42280967
Blood albumin decreased 51 14.73 28 331088 15374 42274845
Duodenal ulcer 50.84 14.73 16 331100 12263 42277956
Pulmonary hypertension 50.81 14.73 65 331051 23504 42266715
Cardiomegaly 50.60 14.73 34 331082 16732 42273487
Hypertriglyceridaemia 50.16 14.73 9 331107 10117 42280102
Haematoma 50.02 14.73 88 331028 27935 42262284
Adrenal insufficiency 49.95 14.73 44 331072 18880 42271339
Blood pressure diastolic decreased 49.74 14.73 10 331106 10365 42279854
Blood loss anaemia 49.67 14.73 8 331108 9728 42280491
Metastases to liver 49.42 14.73 33 331083 16293 42273926
Hepatic cirrhosis 49.42 14.73 48 331068 19654 42270565
Normochromic normocytic anaemia 49.41 14.73 6 331110 9025 42281194
Balance disorder 49.37 14.73 577 330539 47068 42243151
Lower limb fracture 49.18 14.73 115 331001 4852 42285367
Left ventricular hypertrophy 49.05 14.73 7 331109 9312 42280907
Liver function test abnormal 49.01 14.73 112 331004 32279 42257940
Pulmonary alveolar haemorrhage 48.96 14.73 27 331089 14789 42275430
Schizophrenia 48.88 14.73 11 331105 10539 42279680
Hypothermia 48.88 14.73 18 331098 12497 42277722
Rales 48.75 14.73 14 331102 11386 42278833
Fracture 48.54 14.73 156 330960 7947 42282272
Nephropathy toxic 48.38 14.73 36 331080 16802 42273417
Subarachnoid haemorrhage 48.37 14.73 26 331090 14446 42275773
Sputum discoloured 48.09 14.73 10 331106 10122 42280097
Platelet disorder 47.85 14.73 71 331045 2103 42288116
Mitral valve incompetence 47.70 14.73 35 331081 16454 42273765
Post transplant lymphoproliferative disorder 47.66 14.73 7 331109 9113 42281106
Blood creatinine increased 47.60 14.73 586 330530 109417 42180802
Jaw disorder 47.44 14.73 70 331046 2063 42288156
Dyspnoea exertional 47.43 14.73 214 330902 49934 42240285
Stem cell transplant 47.35 14.73 79 331037 2593 42287626
Frequent bowel movements 47.23 14.73 58 331058 21349 42268870
Iron deficiency 46.54 14.73 14 331102 11047 42279172
Disturbance in attention 46.22 14.73 102 331014 29764 42260455
Clostridium difficile infection 46.12 14.73 318 330798 22341 42267878
Migraine 46.10 14.73 79 331037 25335 42264884
Blood electrolytes decreased 45.71 14.73 35 331081 467 42289752
Acute respiratory distress syndrome 45.64 14.73 104 331012 30004 42260215
Parkinsonism 45.51 14.73 13 331103 10610 42279609
Type 2 diabetes mellitus 45.18 14.73 46 331070 18425 42271794
Femur fracture 45.03 14.73 173 330943 9639 42280580
Visceral leishmaniasis 44.90 14.73 50 331066 1104 42289115
Refractory anaemia with an excess of blasts 44.59 14.73 30 331086 322 42289897
Vertebral lesion 44.48 14.73 26 331090 213 42290006
Blood pressure decreased 44.45 14.73 268 330848 58064 42232155
Exposure during pregnancy 43.66 14.73 7 331109 8541 42281678
Device dislocation 43.35 14.73 5 331111 7826 42282393
Knee arthroplasty 43.08 14.73 8 331108 8773 42281446
Product dispensing issue 42.92 14.73 26 331090 229 42289990
Hyperthermia 42.90 14.73 22 331094 12552 42277667
Joint range of motion decreased 42.79 14.73 5 331111 7748 42282471
Kidney transplant rejection 42.41 14.73 8 331108 8675 42281544
Basosquamous carcinoma of skin 42.24 14.73 12 331104 5 42290214
Hyperthyroidism 42.06 14.73 30 331086 14311 42275908
Metastases to lung 42.04 14.73 18 331098 11406 42278813
Ataxia 41.95 14.73 38 331078 16087 42274132
Bronchospasm 41.84 14.73 24 331092 12861 42277358
Therapeutic response unexpected 41.77 14.73 18 331098 11363 42278856
Injury 41.74 14.73 68 331048 22248 42267971
Speech disorder 41.43 14.73 104 331012 29017 42261202
Neutrophil count abnormal 41.40 14.73 76 331040 2695 42287524
Respiratory rate increased 41.40 14.73 17 331099 11045 42279174
Muscle spasticity 41.39 14.73 3 331113 6819 42283400
Acute hepatic failure 41.21 14.73 43 331073 17030 42273189
Eye infection 41.04 14.73 99 331017 4262 42285957
Sleep disorder 40.97 14.73 213 330903 47882 42242337
Blood cholesterol increased 40.83 14.73 92 331024 26649 42263570
Discomfort 40.80 14.73 84 331032 25135 42265084
Hypokinesia 40.62 14.73 13 331103 9858 42280361
Swollen tongue 40.37 14.73 64 331052 21167 42269052
Upper respiratory tract infection 40.31 14.73 503 330613 41670 42248549
Renal tubular necrosis 40.20 14.73 50 331066 18304 42271915
Toothache 40.11 14.73 140 330976 7443 42282776
Respiratory symptom 40.08 14.73 18 331098 11088 42279131
Hypotonia 40.01 14.73 12 331104 9487 42280732
Iron deficiency anaemia 39.95 14.73 26 331090 13013 42277206
Klebsiella infection 39.91 14.73 19 331097 11313 42278906
Spinal cord compression 39.87 14.73 96 331020 4128 42286091
Cardiac murmur 39.79 14.73 25 331091 12750 42277469
Nodule 39.77 14.73 24 331092 12510 42277709
Osteoarthritis 39.73 14.73 81 331035 24324 42265895
Renal injury 39.69 14.73 23 331093 12257 42277962
Benign prostatic hyperplasia 39.52 14.73 64 331052 20988 42269231
Tardive dyskinesia 39.40 14.73 4 331112 6920 42283299
Injection site pruritus 39.39 14.73 12 331104 9393 42280826
Hypertensive crisis 39.32 14.73 15 331101 10191 42280028
Myocardial ischaemia 39.32 14.73 48 331068 17714 42272505
Pulmonary arterial hypertension 39.20 14.73 15 331101 10172 42280047
Dysphonia 39.15 14.73 365 330751 28085 42262134
Respiratory tract congestion 39.10 14.73 140 330976 7538 42282681
Cardiac valve disease 39.08 14.73 84 331032 3347 42286872
Adverse reaction 39.04 14.73 92 331024 3901 42286318
Cerebral haemorrhage 38.84 14.73 163 330953 38803 42251416
Abdominal discomfort 38.81 14.73 810 330306 74445 42215774
Vitamin D decreased 38.81 14.73 99 331017 4416 42285803
Hypotension 38.71 14.73 1622 329494 256009 42034210
Hepatitis cholestatic 38.58 14.73 14 331102 9810 42280409
Adenovirus infection 38.57 14.73 4 331112 6805 42283414
Glomerular filtration rate decreased 38.56 14.73 42 331074 16309 42273910
Disease recurrence 38.44 14.73 111 331005 29567 42260652
Pneumothorax 38.44 14.73 78 331038 23465 42266754
Chest pain 38.38 14.73 809 330307 138721 42151498
Heart rate increased 38.34 14.73 249 330867 53006 42237213
Enterococcal infection 38.27 14.73 23 331093 12016 42278203
Pneumonia influenzal 38.22 14.73 60 331056 1869 42288350
Mania 38.21 14.73 17 331099 10530 42279689
Contusion 38.11 14.73 496 330620 41489 42248730
Chondrocalcinosis pyrophosphate 37.92 14.73 41 331075 875 42289344
Platelet count abnormal 37.79 14.73 86 331030 3563 42286656
Blood pressure abnormal 37.76 14.73 166 330950 9832 42280387
Blood uric acid increased 37.71 14.73 39 331077 15508 42274711
Sinus bradycardia 37.47 14.73 36 331080 14817 42275402
Atrial flutter 37.45 14.73 246 330870 17005 42273214
Anhedonia 37.39 14.73 7 331109 7633 42282586
Limb discomfort 37.39 14.73 197 330919 12570 42277649
Musculoskeletal chest pain 37.11 14.73 179 330937 11025 42279194
Angina pectoris 37.04 14.73 131 330985 32765 42257454
Hypopnoea 36.96 14.73 8 331108 7874 42282345
Blood immunoglobulin A increased 36.90 14.73 29 331087 403 42289816
Peritonitis bacterial 36.85 14.73 5 331111 6910 42283309
Swelling 36.70 14.73 615 330501 54270 42235949
Troponin increased 36.68 14.73 57 331059 19005 42271214
Aphasia 36.65 14.73 83 331033 24000 42266219
Eosinophil count increased 36.47 14.73 19 331097 10744 42279475
Viral infection 36.42 14.73 299 330817 22184 42268035
Arteriosclerosis 36.36 14.73 52 331064 17937 42272282
Angina unstable 36.21 14.73 22 331094 11426 42278793
Oesophagitis 36.13 14.73 39 331077 15208 42275011
Burns second degree 36.08 14.73 3 331113 6093 42284126
POEMS syndrome 36.04 14.73 14 331102 38 42290181
Asphyxia 36.02 14.73 10 331106 8316 42281903
Myalgia 35.70 14.73 528 330588 95552 42194667
Behaviour disorder 35.53 14.73 6 331110 7048 42283171
Paraproteinaemia 35.51 14.73 28 331088 391 42289828
Vasculitis 35.40 14.73 55 331061 18339 42271880
Appendix disorder 35.40 14.73 35 331081 670 42289549
Dyspnoea 35.32 14.73 2960 328156 439661 41850558
Disorientation 35.18 14.73 154 330962 36235 42253984
Left ventricular dysfunction 35.14 14.73 23 331093 11478 42278741
Chills 34.93 14.73 517 330599 93549 42196670
Motor dysfunction 34.84 14.73 10 331106 8136 42282083
Oral disorder 34.81 14.73 99 331017 4713 42285506
Cholangitis 34.80 14.73 20 331096 10707 42279512
Rhinorrhoea 34.71 14.73 389 330727 31405 42258814
Ejection fraction decreased 34.53 14.73 75 331041 22012 42268207
Wrong product administered 34.40 14.73 4 331112 6222 42283997
Liver injury 34.29 14.73 60 331056 19088 42271131
Tricuspid valve incompetence 34.26 14.73 22 331094 11091 42279128
Electrocardiogram abnormal 34.24 14.73 18 331098 10127 42280092
Pseudomonas infection 34.23 14.73 44 331072 15879 42274340
Coordination abnormal 34.21 14.73 10 331106 8040 42282179
Glycosylated haemoglobin increased 34.17 14.73 30 331086 12894 42277325
Blood lactic acid increased 34.14 14.73 10 331106 8029 42282190
Hepatic enzyme increased 34.02 14.73 212 330904 45572 42244647
Rectal adenocarcinoma 33.78 14.73 40 331076 946 42289273
Oliguria 33.75 14.73 15 331101 9298 42280921
Blood iron decreased 33.72 14.73 117 330999 6201 42284018
Euphoric mood 33.61 14.73 5 331111 6448 42283771
Haemodialysis 33.47 14.73 19 331097 10241 42279978
Respiratory tract infection 33.41 14.73 332 330784 25990 42264229
Hydronephrosis 33.28 14.73 26 331090 11839 42278380
Multiple fractures 33.28 14.73 50 331066 1498 42288721
Pneumonitis 33.20 14.73 189 330927 41529 42248690
Viral upper respiratory tract infection 33.17 14.73 75 331041 3094 42287125
Multiple sclerosis 33.10 14.73 9 331107 7589 42282630
Product storage error 33.07 14.73 23 331093 11117 42279102
Aspiration 32.99 14.73 55 331061 17831 42272388
Metastases to lymph nodes 32.78 14.73 4 331112 5994 42284225
Metastases to central nervous system 32.61 14.73 20 331096 10335 42279884
Lower gastrointestinal haemorrhage 32.51 14.73 22 331094 10786 42279433
Bile acid malabsorption 32.13 14.73 17 331099 112 42290107
Pleural effusion 32.07 14.73 546 330570 96620 42193599
Blood lactate dehydrogenase increased 32.02 14.73 100 331016 25981 42264238
Pelvic fracture 31.77 14.73 67 331049 2634 42287585
Epstein-Barr virus infection 31.70 14.73 18 331098 9700 42280519
Primary amyloidosis 31.64 14.73 21 331095 220 42289999
Device occlusion 31.60 14.73 13 331103 8437 42281782
Haemorrhage intracranial 31.59 14.73 53 331063 17139 42273080
Intentional product use issue 31.32 14.73 755 330361 71078 42219141
Musculoskeletal stiffness 31.32 14.73 292 330824 57473 42232746
Blood magnesium decreased 31.27 14.73 131 330985 7595 42282624
Hyperammonaemia 31.25 14.73 11 331105 7855 42282364
TP53 gene mutation 31.16 14.73 13 331103 45 42290174
Micturition urgency 31.00 14.73 28 331088 11870 42278349
Eye swelling 30.93 14.73 178 330938 11742 42278477
Exercise tolerance decreased 30.91 14.73 5 331111 6061 42284158
Dysphagia 30.84 14.73 389 330727 72330 42217889
Low density lipoprotein increased 30.72 14.73 3 331113 5352 42284867
Myocarditis 30.70 14.73 63 331053 18875 42271344
Gastritis 30.70 14.73 90 331026 23857 42266362
Ketoacidosis 30.69 14.73 3 331113 5349 42284870
Salivary hypersecretion 30.67 14.73 24 331092 10919 42279300
Lymphocyte count decreased 30.48 14.73 112 331004 27697 42262522
Rash macular 30.31 14.73 230 330886 16661 42273558
Autoimmune hepatitis 30.28 14.73 4 331112 5641 42284578
Anuria 30.21 14.73 27 331089 11505 42278714
Tumour marker increased 30.18 14.73 35 331081 809 42289410
Cerebral haematoma 30.03 14.73 4 331112 5606 42284613
Sternal fracture 30.01 14.73 35 331081 814 42289405
Abdominal distension 29.95 14.73 385 330731 71350 42218869
Tendonitis 29.94 14.73 20 331096 9874 42280345
Hyperviscosity syndrome 29.79 14.73 22 331094 277 42289942
Abdominal pain lower 29.70 14.73 30 331086 12062 42278157
Palmar-plantar erythrodysaesthesia syndrome 29.67 14.73 73 331043 20509 42269710
Neuralgic amyotrophy 29.59 14.73 22 331094 280 42289939
Skin plaque 29.50 14.73 5 331111 5858 42284361
Partial seizures 29.48 14.73 5 331111 5854 42284365
Red blood cell count abnormal 29.45 14.73 34 331082 782 42289437
Right ventricular failure 29.34 14.73 19 331097 9536 42280683
Apnoea 29.19 14.73 12 331104 7791 42282428
Type 1 diabetes mellitus 29.17 14.73 4 331112 5483 42284736
Pneumonia viral 29.05 14.73 86 331030 4188 42286031
Eosinophilia 28.99 14.73 144 330972 32755 42257464
Red cell distribution width increased 28.96 14.73 9 331107 6955 42283264
Subdural haematoma 28.91 14.73 88 331028 23050 42267169
Cellulitis 28.91 14.73 654 330462 60931 42229288
Methaemoglobinaemia 28.89 14.73 5 331111 5769 42284450
Hepatitis acute 28.74 14.73 17 331099 8958 42281261
End stage renal disease 28.65 14.73 53 331063 16505 42273714
Auditory disorder 28.61 14.73 28 331088 529 42289690
Pulmonary function test decreased 28.60 14.73 5 331111 5727 42284492
Ventricular hypokinesia 28.45 14.73 9 331107 6875 42283344
Atelectasis 28.44 14.73 68 331048 19293 42270926
Blood disorder 28.43 14.73 82 331034 3935 42286284
Hypercapnia 28.28 14.73 4 331112 5357 42284862
Granulocytopenia 28.17 14.73 10 331106 7104 42283115
Refractory cytopenia with multilineage dysplasia 28.11 14.73 16 331100 124 42290095
Aspergillus infection 28.02 14.73 50 331066 15787 42274432
Respiratory syncytial virus infection 27.97 14.73 120 330996 7032 42283187
Oral infection 27.96 14.73 60 331056 2388 42287831
Electrocardiogram ST segment elevation 27.90 14.73 6 331110 5933 42284286
Middle insomnia 27.79 14.73 13 331103 7820 42282399
Gastritis erosive 27.78 14.73 8 331108 6495 42283724
Cholecystitis infective 27.66 14.73 59 331057 2338 42287881
Coronary artery stenosis 27.55 14.73 24 331092 10355 42279864
Pulmonary congestion 27.53 14.73 50 331066 15680 42274539
Cardiac amyloidosis 27.48 14.73 53 331063 1952 42288267
Amylase increased 27.45 14.73 9 331107 6720 42283499
Amyloidosis 27.30 14.73 59 331057 2360 42287859
Psychomotor skills impaired 27.18 14.73 4 331112 5200 42285019
Transfusion 27.09 14.73 25 331091 10489 42279730
Enthesopathy 26.93 14.73 3 331113 4825 42285394
Limb injury 26.92 14.73 197 330919 14108 42276111
Squamous cell carcinoma 26.90 14.73 183 330933 12799 42277420
Hypovolaemic shock 26.89 14.73 17 331099 8642 42281577
Colon cancer 26.73 14.73 147 330969 9534 42280685
Acute myocardial infarction 26.62 14.73 306 330810 57859 42232360
Chronic graft versus host disease 26.51 14.73 7 331109 6018 42284201
Aphonia 26.33 14.73 82 331034 4107 42286112
Visual acuity reduced 26.29 14.73 61 331055 17489 42272730
Skin fissures 26.14 14.73 22 331094 9654 42280565
Therapy partial responder 26.13 14.73 254 330862 19767 42270452
Stent placement 26.05 14.73 5 331111 5355 42284864
Lung adenocarcinoma 26.05 14.73 96 331020 5243 42284976
Tenosynovitis 25.98 14.73 3 331113 4692 42285527
Urinary incontinence 25.95 14.73 84 331032 21584 42268635
Hepatomegaly 25.92 14.73 32 331084 11753 42278466
Dialysis 25.89 14.73 33 331083 11953 42278266
Rhinitis 25.85 14.73 33 331083 11944 42278275
Intracranial pressure increased 25.83 14.73 3 331113 4671 42285548
Diverticulitis 25.48 14.73 280 330836 22493 42267726
Arthropod bite 25.43 14.73 69 331047 3195 42287024
IVth nerve paralysis 25.43 14.73 27 331089 564 42289655
Alanine aminotransferase abnormal 25.36 14.73 4 331112 4940 42285279
Clavicle fracture 25.35 14.73 61 331055 2622 42287597
Brain injury 25.22 14.73 14 331102 7641 42282578
Lymphocytic leukaemia 25.16 14.73 18 331098 215 42290004
Drug effective for unapproved indication 25.14 14.73 10 331106 6623 42283596
Sickle cell anaemia with crisis 24.99 14.73 4 331112 4886 42285333
Systemic infection 24.99 14.73 5 331111 5200 42285019
Respiratory acidosis 24.90 14.73 9 331107 6322 42283897
Pneumonia respiratory syncytial viral 24.88 14.73 42 331074 1392 42288827
Pulse absent 24.88 14.73 9 331107 6318 42283901
Lip swelling 24.87 14.73 71 331045 18982 42271237
Hepatic fibrosis 24.86 14.73 4 331112 4868 42285351
Post procedural complication 24.85 14.73 37 331079 12553 42277666
Skin sensitisation 24.84 14.73 19 331097 253 42289966
Herpes simplex 24.83 14.73 12 331104 7083 42283136
Skin necrosis 24.79 14.73 9 331107 6305 42283914
Prescribed underdose 24.70 14.73 26 331090 10256 42279963
Cardiac tamponade 24.56 14.73 10 331106 6530 42283689
Cardiac failure chronic 24.53 14.73 23 331093 9578 42280641
Bradykinesia 24.53 14.73 6 331110 5430 42284789
Brain herniation 24.52 14.73 4 331112 4819 42285400
Off label use 24.38 14.73 4479 326637 633856 41656363
Acute graft versus host disease 24.34 14.73 17 331099 8198 42282021
Portal hypertension 24.27 14.73 4 331112 4783 42285436
Myocardial infarction 24.22 14.73 1187 329929 122822 42167397
Serum ferritin increased 24.08 14.73 13 331103 7206 42283013
Pneumatosis intestinalis 24.03 14.73 4 331112 4748 42285471
Polyneuropathy 23.98 14.73 236 330880 18425 42271794
Toxic encephalopathy 23.97 14.73 12 331104 6941 42283278
Night sweats 23.97 14.73 249 330867 19720 42270499
Therapy non-responder 23.92 14.73 563 330553 52796 42237423
Bone erosion 23.91 14.73 3 331113 4400 42285819
Bladder disorder 23.80 14.73 73 331043 3626 42286593
Amnesia 23.77 14.73 331 330785 28106 42262113
Incorrect product administration duration 23.75 14.73 8 331108 5872 42284347
Hiatus hernia 23.70 14.73 19 331097 8541 42281678
Blood test 23.69 14.73 8 331108 12 42290207
Exposure to toxic agent 23.62 14.73 5 331111 4999 42285220
Bone loss 23.59 14.73 27 331089 615 42289604
Vitamin D deficiency 23.53 14.73 17 331099 8056 42282163
Hypervolaemia 23.50 14.73 96 331020 23029 42267190
Lung opacity 23.47 14.73 8 331108 5829 42284390
Duodenitis 23.43 14.73 7 331109 5549 42284670
Spinal column injury 23.42 14.73 27 331089 620 42289599
Panic attack 23.25 14.73 31 331085 11014 42279205
Eye movement disorder 23.22 14.73 5 331111 4940 42285279
Spinal osteoarthritis 23.16 14.73 20 331096 8666 42281553
Hyperglycaemia 23.09 14.73 236 330880 45623 42244596
Neutrophilia 23.02 14.73 7 331109 5485 42284734
Idiopathic pulmonary fibrosis 23.01 14.73 4 331112 4600 42285619
Renal tubular disorder 22.98 14.73 5 331111 4904 42285315
Gastroenteritis viral 22.98 14.73 125 330991 8074 42282145
Gait inability 22.97 14.73 275 330841 22558 42267661
5q minus syndrome 22.86 14.73 14 331102 126 42290093
Myeloma cast nephropathy 22.81 14.73 13 331103 101 42290118
Oesophageal carcinoma 22.76 14.73 25 331091 9671 42280548
Prothrombin time prolonged 22.68 14.73 24 331092 9445 42280774
Portal vein thrombosis 22.63 14.73 4 331112 4545 42285674
Bundle branch block left 22.59 14.73 11 331105 6465 42283754
Erectile dysfunction 22.55 14.73 108 331008 24805 42265414
Hypertransaminasaemia 22.54 14.73 23 331093 9204 42281015
Orthopnoea 22.53 14.73 7 331109 5410 42284809
Precursor B-lymphoblastic lymphoma 22.52 14.73 9 331107 27 42290192
Peritonitis 22.48 14.73 72 331044 18561 42271658
Lentigo maligna 22.46 14.73 21 331095 374 42289845
Blood calcium increased 22.43 14.73 127 330989 8327 42281892
Weight decreased 22.37 14.73 1891 329225 206057 42084162
Intraocular pressure increased 22.33 14.73 11 331105 6422 42283797
Coronary artery bypass 22.31 14.73 5 331111 4805 42285414
Necrosis 22.15 14.73 12 331104 6639 42283580
Blood chloride decreased 22.04 14.73 3 331113 4136 42286083
Gastrointestinal motility disorder 22.01 14.73 61 331055 2860 42287359
Appendicitis 21.95 14.73 84 331032 20529 42269690
Flatulence 21.93 14.73 295 330821 24857 42265362
Arthritis 21.79 14.73 215 330901 41850 42248369
Haemolytic anaemia 21.71 14.73 38 331078 12089 42278130
Dermatitis allergic 21.57 14.73 126 330990 8357 42281862
Bradyphrenia 21.53 14.73 7 331109 5255 42284964
Pyelonephritis 21.37 14.73 18 331098 7896 42282323
Transplant failure 21.37 14.73 3 331113 4041 42286178
Hepatitis fulminant 21.37 14.73 6 331110 4953 42285266
Plasma cell myeloma in remission 21.34 14.73 8 331108 19 42290200
Skin atrophy 21.32 14.73 55 331061 2470 42287749
Polyuria 21.17 14.73 28 331088 9983 42280236
Hypoxic-ischaemic encephalopathy 21.14 14.73 7 331109 5195 42285024
Neoplasm 21.08 14.73 101 331015 6204 42284015
Pneumonia parainfluenzae viral 21.08 14.73 18 331098 283 42289936
Neurological symptom 21.07 14.73 28 331088 9963 42280256
Rebound effect 20.91 14.73 16 331100 7363 42282856
Colon cancer metastatic 20.76 14.73 43 331073 1669 42288550
Stevens-Johnson syndrome 20.75 14.73 95 331021 22083 42268136
Vertigo 20.66 14.73 169 330947 34178 42256041
Crying 20.63 14.73 12 331104 6382 42283837
Venoocclusive disease 20.47 14.73 3 331113 3912 42286307
Gait disturbance 20.45 14.73 592 330524 97408 42192811
Venous thrombosis limb 20.42 14.73 52 331064 2317 42287902
Feeling jittery 20.39 14.73 79 331037 4419 42285800
Bladder transitional cell carcinoma 20.28 14.73 56 331060 2620 42287599
Hypernatraemia 20.27 14.73 29 331087 10003 42280216
Diplopia 20.24 14.73 85 331031 20231 42269988
Product preparation error 20.19 14.73 6 331110 4772 42285447
Muscle twitching 20.12 14.73 38 331078 11742 42278477
H1N1 influenza 20.07 14.73 34 331082 1130 42289089
Depressive symptom 20.03 14.73 3 331113 3850 42286369
Cardiotoxicity 20.03 14.73 17 331099 7428 42282791
Encephalitis 20.00 14.73 25 331091 9133 42281086
Cytomegalovirus viraemia 19.99 14.73 31 331085 10346 42279873
Expired product administered 19.98 14.73 4 331112 4159 42286060
Central nervous system lesion 19.94 14.73 19 331097 7851 42282368
Salmonellosis 19.90 14.73 36 331080 1262 42288957
Bladder transitional cell carcinoma stage 0 19.87 14.73 12 331104 105 42290114
Haemorrhagic stroke 19.79 14.73 17 331099 7385 42282834
Nausea 19.73 14.73 2742 328374 394057 41896162
Weight fluctuation 19.66 14.73 95 331021 5856 42284363
Muscle strain 19.63 14.73 79 331037 4498 42285721
Infusion site extravasation 19.60 14.73 9 331107 5472 42284747
Neurological decompensation 19.59 14.73 3 331113 3786 42286433
Ulcer 19.51 14.73 64 331052 16377 42273842
Large intestine polyp 19.51 14.73 26 331090 9239 42280980
Cervical vertebral fracture 19.47 14.73 51 331065 2312 42287907
Spinal cord neoplasm 19.36 14.73 17 331099 278 42289941
Disability 19.33 14.73 11 331105 5922 42284297
Colorectal adenocarcinoma 19.32 14.73 18 331098 319 42289900
Proctalgia 19.32 14.73 16 331100 7077 42283142
Enteritis 19.27 14.73 34 331082 10782 42279437
Areflexia 19.27 14.73 3 331113 3740 42286479
Immunoglobulins increased 19.23 14.73 15 331101 206 42290013
Disease complication 19.21 14.73 60 331056 3010 42287209
Granuloma 19.15 14.73 4 331112 4037 42286182
Atrioventricular block complete 19.11 14.73 37 331079 11327 42278892
Therapeutic product effect decreased 19.09 14.73 203 330913 38947 42251272
Major depression 19.09 14.73 9 331107 5389 42284830
Failure to thrive 19.04 14.73 132 330984 9290 42280929
Urticaria 18.99 14.73 729 330387 73307 42216912
Vascular device infection 18.97 14.73 12 331104 6098 42284121
Anger 18.90 14.73 46 331070 12972 42277247
Immunoglobulins abnormal 18.86 14.73 7 331109 16 42290203
Polyarthritis 18.85 14.73 8 331108 5096 42285123
Lacrimation increased 18.84 14.73 156 330960 11602 42278617
Hemiplegia 18.84 14.73 20 331096 7859 42282360
Sarcoidosis 18.84 14.73 3 331113 3679 42286540
Lymphoma 18.84 14.73 182 330934 14139 42276080
Hydrocephalus 18.78 14.73 12 331104 6066 42284153
Furuncle 18.78 14.73 68 331048 3682 42286537
Post procedural haemorrhage 18.74 14.73 27 331089 9285 42280934
Inflammatory marker increased 18.70 14.73 15 331101 6741 42283478
Device breakage 18.61 14.73 3 331113 3646 42286573
Tumour haemorrhage 18.54 14.73 3 331113 3635 42286584
Psychiatric symptom 18.52 14.73 5 331111 4236 42285983
Blood immunoglobulin E increased 18.45 14.73 3 331113 3622 42286597
Scar 18.32 14.73 15 331101 6673 42283546
Bone marrow failure 18.31 14.73 360 330756 32733 42257486
Mental impairment 18.30 14.73 43 331073 12274 42277945
Haemophagocytic lymphohistiocytosis 18.30 14.73 76 331040 18146 42272073
Fibromyalgia 18.29 14.73 4 331112 3909 42286310
Blood stem cell harvest 18.29 14.73 7 331109 18 42290201
Gastrooesophageal reflux disease 18.28 14.73 243 330873 44780 42245439
Blood immunoglobulin M increased 18.20 14.73 16 331100 262 42289957
Arteriospasm coronary 18.19 14.73 7 331109 4731 42285488
Catheter site thrombosis 18.12 14.73 13 331103 156 42290063
Dermatitis acneiform 18.11 14.73 20 331096 7719 42282500
Treatment noncompliance 18.10 14.73 196 330920 37476 42252743
Chronic kidney disease 17.75 14.73 259 330857 46982 42243237
Psychomotor retardation 17.74 14.73 6 331110 4393 42285826
Dissociation 17.51 14.73 4 331112 3794 42286425
Dry eye 17.51 14.73 191 330925 15315 42274904
Kidney infection 17.50 14.73 101 331015 6669 42283550
Injection site induration 17.49 14.73 3 331113 3484 42286735
Endotracheal intubation 17.43 14.73 4 331112 3781 42286438
Liver function test increased 17.35 14.73 88 331028 19910 42270309
Gingival disorder 17.32 14.73 38 331078 1536 42288683
Mucormycosis 17.23 14.73 18 331098 7125 42283094
Pericardial effusion 17.18 14.73 145 330971 29130 42261089
Procedural pain 17.06 14.73 12 331104 5767 42284452
Congestive cardiomyopathy 17.06 14.73 26 331090 8738 42281481
Peptic ulcer 16.97 14.73 3 331113 3409 42286810
Presyncope 16.97 14.73 103 331013 22284 42267935
Ischaemia 16.97 14.73 9 331107 5038 42285181
Occult blood positive 16.83 14.73 6 331110 4251 42285968
Cardiac operation 16.82 14.73 4 331112 3691 42286528
Bundle branch block right 16.81 14.73 23 331093 8083 42282136
Acute lymphocytic leukaemia recurrent 16.80 14.73 4 331112 3687 42286532
Haemothorax 16.65 14.73 10 331106 5226 42284993
Device related infection 16.61 14.73 91 331025 20188 42270031
Monocyte count increased 16.58 14.73 12 331104 5682 42284537
Immunoglobulins decreased 16.57 14.73 29 331087 990 42289229
Pulmonary toxicity 16.54 14.73 26 331090 8629 42281590
Transplant dysfunction 16.50 14.73 3 331113 3340 42286879
Acute graft versus host disease in skin 16.50 14.73 20 331096 7404 42282815
Mean cell volume increased 16.44 14.73 5 331111 3918 42286301
Transitional cell cancer of the renal pelvis and ureter 16.41 14.73 7 331109 26 42290193
Cardiomyopathy 16.40 14.73 85 331031 19125 42271094
Aortic valve incompetence 16.37 14.73 16 331100 6532 42283687
Deafness 16.32 14.73 165 330951 12975 42277244
Musculoskeletal pain 16.20 14.73 173 330943 33167 42257052
Squamous cell carcinoma of the hypopharynx 16.08 14.73 6 331110 14 42290205
Atrioventricular block first degree 16.06 14.73 16 331100 6475 42283744
Acute respiratory failure 16.05 14.73 209 330907 38649 42251570
Muscle haemorrhage 16.00 14.73 6 331110 4119 42286100
Pericardial haemorrhage 15.98 14.73 4 331112 3565 42286654
Nasal polyps 15.97 14.73 5 331111 3846 42286373
Eosinophilic pneumonia 15.94 14.73 9 331107 4865 42285354
Mental disorder 15.83 14.73 79 331037 17950 42272269
Eyelid ptosis 15.83 14.73 17 331099 6644 42283575
Renal cyst 15.77 14.73 34 331082 10005 42280214
Retinal haemorrhage 15.74 14.73 13 331103 5757 42284462
Cerebral atrophy 15.73 14.73 10 331106 5069 42285150
Cold sweat 15.70 14.73 41 331075 11289 42278930
Therapeutic response decreased 15.68 14.73 198 330918 36814 42253405
Blood sodium increased 15.64 14.73 3 331113 3215 42287004
Ventricular hypertrophy 15.59 14.73 9 331107 4807 42285412
Osteomyelitis 15.59 14.73 213 330903 18010 42272209
Respiratory tract infection viral 15.58 14.73 60 331056 3346 42286873
Hypovolaemia 15.58 14.73 42 331074 11443 42278776
Anal abscess 15.56 14.73 23 331093 7827 42282392
Corticobasal degeneration 15.52 14.73 6 331110 16 42290203
Clostridium test positive 15.52 14.73 12 331104 5493 42284726
Hyperaesthesia 15.51 14.73 14 331102 5938 42284281
Papillary thyroid cancer 15.49 14.73 24 331092 739 42289480
Gastric ulcer 15.48 14.73 81 331035 18181 42272038
Drooling 15.46 14.73 7 331109 4292 42285927
Renal oncocytoma 15.45 14.73 13 331103 200 42290019
Abdominal tenderness 15.43 14.73 9 331107 4780 42285439
Ear swelling 15.41 14.73 21 331095 574 42289645
Photosensitivity reaction 15.38 14.73 49 331067 12653 42277566
Adenocarcinoma gastric 15.34 14.73 34 331082 1384 42288835
Cyst 15.32 14.73 82 331034 5264 42284955
Laryngeal oedema 15.26 14.73 6 331110 4002 42286217
Tuberculosis 15.21 14.73 35 331081 10064 42280155
Ventricular dysfunction 15.18 14.73 8 331108 4495 42285724
Ischaemic cardiomyopathy 15.10 14.73 17 331099 6505 42283714
Liver abscess 15.10 14.73 10 331106 4960 42285259
Snoring 15.04 14.73 6 331110 3967 42286252
Aortic valve disease 15.04 14.73 33 331083 1334 42288885
Metastatic squamous cell carcinoma 14.99 14.73 22 331094 645 42289574
Spinal operation 14.98 14.73 7 331109 4213 42286006
Hyperaesthesia teeth 14.95 14.73 21 331095 591 42289628
Cardiac failure 14.92 14.73 678 330438 106178 42184041
Gastric infection 14.90 14.73 35 331081 1481 42288738
Intestinal obstruction 14.88 14.73 295 330821 26863 42263356
Lung consolidation 14.82 14.73 18 331098 6659 42283560
Pneumonia legionella 14.82 14.73 45 331071 2223 42287996
Lymphodepletion 14.79 14.73 7 331109 35 42290184
Corneal abscess 14.78 14.73 6 331110 19 42290200

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
Death 10082.90 13.90 12870 413074 685999 109477356
Full blood count decreased 7493.34 13.90 3245 422699 28854 110134501
White blood cell count decreased 5895.73 13.90 5731 420213 223659 109939696
Neuropathy peripheral 5621.25 13.90 5005 420939 174272 109989083
Pneumonia 5594.65 13.90 11131 414813 865583 109297772
Diarrhoea 5374.07 13.90 12800 413144 1126705 109036650
Thrombosis 4772.99 13.90 3690 422254 104972 110058383
Platelet count decreased 4687.26 13.90 5078 420866 225365 109937990
Rash 3650.63 13.90 9032 416912 811932 109351423
Neutropenia 3370.55 13.90 5536 420408 369084 109794271
Fatigue 2565.19 13.90 10333 415611 1205625 108957730
Deep vein thrombosis 2538.31 13.90 2907 423037 136980 110026375
Constipation 1831.14 13.90 4167 421777 353619 109809736
Plasma cell myeloma recurrent 1804.13 13.90 761 425183 6281 110157074
Unevaluable event 1786.11 13.90 1620 424324 57607 110105748
Plasma cell myeloma 1673.48 13.90 1605 424339 61331 110102024
Thrombocytopenia 1500.05 13.90 3799 422145 345086 109818269
COVID-19 1488.27 13.90 3060 422884 242000 109921355
Laboratory test abnormal 1434.71 13.90 1259 424685 42820 110120535
Human chorionic gonadotropin increased 1394.57 13.90 424 425520 1108 110162247
Neutrophil count decreased 1359.51 13.90 1984 423960 118957 110044398
Drug interaction 1321.03 13.90 181 425763 500002 109663353
Pancytopenia 1268.35 13.90 2614 423330 206999 109956356
Condition aggravated 1251.96 13.90 635 425309 734201 109429154
Muscle spasms 1236.98 13.90 3069 422875 275088 109888267
Product dose omission issue 1190.93 13.90 3315 422629 318467 109844888
Pulmonary embolism 1104.47 13.90 2506 423438 211968 109951387
Haemoglobin decreased 1018.93 13.90 2661 423283 246066 109917289
Rheumatoid arthritis 1012.34 13.90 31 425913 299582 109863773
Systemic lupus erythematosus 911.51 13.90 13 425931 254325 109909030
Cytopenia 892.48 13.90 816 425128 29300 110134055
Red blood cell count decreased 887.75 13.90 1180 424764 64743 110098612
Anaemia 884.25 13.90 4306 421638 542780 109620575
Pulmonary thrombosis 873.95 13.90 587 425357 13276 110150079
Maternal exposure during pregnancy 866.02 13.90 25 425919 254858 109908497
Synovitis 854.38 13.90 50 425894 274042 109889313
Contraindicated product administered 813.13 13.90 33 425911 248234 109915121
Plasmacytoma 804.49 13.90 397 425547 4865 110158490
Pemphigus 796.69 13.90 5 425939 214565 109948790
Completed suicide 774.84 13.90 38 425906 242343 109921012
Rash pruritic 768.84 13.90 1366 424578 96703 110066652
B-cell type acute leukaemia 737.95 13.90 259 425685 1205 110162150
Drug ineffective 735.08 13.90 3193 422751 1517347 108646008
Drug hypersensitivity 698.27 13.90 444 425500 453646 109709709
Myelodysplastic syndrome 692.48 13.90 787 425157 36697 110126658
Product use in unapproved indication 689.89 13.90 436 425508 446941 109716414
Dehydration 670.93 13.90 2483 423461 277028 109886327
Blood potassium decreased 655.03 13.90 920 425024 53194 110110161
Squamous cell carcinoma of skin 653.15 13.90 537 425407 16666 110146689
Drug abuse 640.27 13.90 8 425936 177403 109985952
Glossodynia 631.12 13.90 62 425882 221942 109941413
Disease progression 629.01 13.90 2219 423725 241815 109921540
Helicobacter infection 613.52 13.90 19 425925 181858 109981497
Overdose 603.97 13.90 90 425854 233704 109929651
Fibromyalgia 602.75 13.90 11 425933 170898 109992457
Acute lymphocytic leukaemia 596.46 13.90 335 425609 5430 110157925
Ageusia 593.23 13.90 538 425406 19107 110144248
Injection site pain 584.73 13.90 23 425921 177899 109985456
Sepsis 578.55 13.90 2646 423298 324700 109838655
Wheezing 569.07 13.90 141 425803 255089 109908266
Acute myeloid leukaemia 567.41 13.90 717 425227 37393 110125962
Pericarditis 564.50 13.90 85 425859 219029 109944326
Asthenia 564.43 13.90 4556 421388 684443 109478912
Mobility decreased 559.69 13.90 116 425828 237306 109926049
Folliculitis 549.84 13.90 22 425922 167631 109995724
Blood cholesterol increased 548.56 13.90 43 425901 184742 109978613
Cardiac disorder 542.73 13.90 1019 424925 75261 110088094
Headache 541.23 13.90 1676 424268 880701 109282654
Renal failure 534.52 13.90 2002 423942 224572 109938783
Plasma cell myeloma refractory 528.44 13.90 221 425723 1780 110161575
Type 2 diabetes mellitus 518.47 13.90 44 425900 177188 109986167
Hip fracture 514.89 13.90 656 425288 34495 110128860
Arthralgia 511.88 13.90 1434 424510 778198 109385157
Atrial fibrillation 508.77 13.90 1989 423955 227653 109935702
Exposure during pregnancy 508.31 13.90 35 425909 167389 109995966
Wound 498.96 13.90 142 425802 234295 109929060
Influenza 498.55 13.90 1609 424335 167492 109995863
Therapeutic product effect decreased 484.25 13.90 168 425776 244148 109919207
Muscle injury 477.46 13.90 14 425930 140793 110022562
Hypertension 473.20 13.90 772 425172 509312 109654043
Discomfort 472.07 13.90 122 425822 214585 109948770
Light chain analysis increased 458.96 13.90 210 425734 2145 110161210
Off label use 454.52 13.90 8197 417747 1491988 108671367
Treatment failure 445.53 13.90 257 425687 276977 109886378
Impaired healing 441.73 13.90 107 425837 196610 109966745
Fall 440.47 13.90 3890 422054 599592 109563763
Infusion related reaction 440.43 13.90 491 425453 380671 109782684
Renal disorder 431.94 13.90 723 425221 48756 110114599
Joint range of motion decreased 424.91 13.90 9 425935 121823 110041532
Tooth disorder 423.22 13.90 545 425399 28964 110134391
Injury 423.17 13.90 84 425860 177181 109986174
C-reactive protein abnormal 421.98 13.90 18 425926 129677 110033678
Urinary tract infection 421.44 13.90 2416 423528 323866 109839489
Alopecia 414.72 13.90 476 425468 364277 109799078
Irritable bowel syndrome 400.08 13.90 74 425870 164141 109999214
Cerebrovascular accident 391.57 13.90 1558 424386 179726 109983629
Osteoarthritis 389.71 13.90 110 425834 182513 109980842
Obesity 381.66 13.90 12 425932 113339 110050016
Product use issue 380.74 13.90 383 425561 311312 109852043
Liver injury 372.45 13.90 65 425879 150348 110013007
Pain 371.62 13.90 2159 423785 952796 109210559
Rheumatoid factor positive 370.82 13.90 38 425906 131602 110031753
Intentional product misuse 367.65 13.90 41 425903 132863 110030492
Migraine 367.00 13.90 103 425841 171549 109991806
Plasma cell leukaemia 365.94 13.90 173 425771 1915 110161440
Hepatic enzyme increased 354.83 13.90 428 425516 320464 109842891
Inflammation 344.92 13.90 156 425788 193082 109970273
Asthma 344.63 13.90 275 425669 250016 109913339
Herpes zoster 343.87 13.90 1058 424886 107321 110056034
Ill-defined disorder 341.19 13.90 91 425853 156762 110006593
Musculoskeletal stiffness 339.26 13.90 346 425598 279476 109883879
Hypercholesterolaemia 323.77 13.90 5 425939 90832 110072523
Weight increased 320.73 13.90 713 425231 418931 109744424
COVID-19 pneumonia 316.55 13.90 537 425407 36606 110126749
Psoriasis 316.50 13.90 75 425869 139918 110023437
Suicide attempt 312.69 13.90 22 425922 103372 110059983
Product distribution issue 305.47 13.90 197 425747 4149 110159206
Skin discolouration 301.23 13.90 616 425328 48430 110114925
Bursitis 300.91 13.90 66 425878 129852 110033503
Medication error 300.47 13.90 29 425915 105337 110058018
Adverse event 299.69 13.90 1012 424932 107797 110055558
Therapy interrupted 295.72 13.90 617 425327 49205 110114150
Anxiety 289.25 13.90 556 425388 344522 109818833
Spinal fracture 278.61 13.90 388 425556 22245 110141110
Adverse drug reaction 276.92 13.90 966 424978 104593 110058762
Therapeutic product effect incomplete 276.67 13.90 272 425672 223533 109939822
Lip dry 276.49 13.90 31 425913 100052 110063303
Peripheral swelling 275.69 13.90 2568 423376 401466 109761889
Blood pressure increased 274.70 13.90 355 425589 258018 109905337
Tachycardia 273.84 13.90 281 425663 226364 109936991
Sleep disorder 265.06 13.90 225 425719 198419 109964936
Bronchitis 264.95 13.90 1253 424691 155779 110007576
Basal cell carcinoma 263.29 13.90 556 425388 44714 110118641
Peripheral venous disease 256.99 13.90 17 425927 84100 110079255
Grip strength decreased 254.72 13.90 13 425931 80161 110083194
Renal impairment 250.69 13.90 1407 424537 187038 109976317
Prescribed overdose 247.39 13.90 25 425919 87556 110075799
Blister 247.33 13.90 307 425637 227069 109936286
Musculoskeletal pain 245.80 13.90 206 425738 182817 109980538
Osteolysis 245.15 13.90 189 425755 5334 110158021
Live birth 242.80 13.90 5 425939 69479 110093876
Coma 242.31 13.90 76 425868 117793 110045562
Abdominal pain 242.01 13.90 1084 424860 511905 109651450
Injection site erythema 239.12 13.90 38 425906 94138 110069217
C-reactive protein increased 238.32 13.90 293 425651 217626 109945729
Adenocarcinoma of colon 235.09 13.90 193 425751 5975 110157380
Wrong technique in product usage process 234.02 13.90 30 425914 87318 110076037
Inappropriate schedule of product administration 232.09 13.90 265 425679 203372 109959983
Cataract 231.99 13.90 754 425190 78731 110084624
Monoclonal immunoglobulin present 229.13 13.90 135 425809 2405 110160950
Depression 228.82 13.90 556 425388 316779 109846576
Autoimmune disorder 227.68 13.90 5 425939 65478 110097877
Tumour flare 227.04 13.90 114 425830 1453 110161902
Knee arthroplasty 225.66 13.90 5 425939 64943 110098412
Sedation 225.57 13.90 10 425934 69673 110093682
Rhabdomyolysis 224.71 13.90 91 425853 120310 110043045
Cardiac failure congestive 223.55 13.90 1161 424783 149839 110013516
Depressed level of consciousness 222.72 13.90 77 425867 112201 110051154
Dry skin 222.59 13.90 913 425031 106740 110056615
Injection site reaction 221.56 13.90 38 425906 89032 110074323
General physical health deterioration 221.43 13.90 865 425079 424430 109738925
Drug-induced liver injury 218.84 13.90 94 425850 119973 110043382
Full blood count abnormal 216.20 13.90 587 425357 55465 110107890
Colitis ulcerative 216.14 13.90 23 425921 77340 110086015
Oxygen saturation decreased 215.37 13.90 173 425771 156809 110006546
Hyponatraemia 213.35 13.90 317 425627 217336 109946019
Hypersensitivity 213.32 13.90 817 425127 403181 109760174
Pruritus 212.20 13.90 3280 422664 578280 109585075
Blood pressure systolic increased 209.55 13.90 34 425910 82957 110080398
Hospitalisation 206.39 13.90 1089 424855 141404 110021951
Loss of personal independence in daily activities 206.22 13.90 165 425779 149855 110013500
Anaphylactic reaction 205.92 13.90 91 425853 114209 110049146
Bone pain 205.77 13.90 635 425309 64498 110098857
Aspartate aminotransferase increased 202.74 13.90 190 425754 159746 110003609
B precursor type acute leukaemia 201.45 13.90 75 425869 426 110162929
Product quality issue 201.27 13.90 29 425915 77270 110086085
Lower respiratory tract infection 199.04 13.90 397 425547 242709 109920646
Hypercalcaemia 196.62 13.90 505 425439 46152 110117203
Vomiting 196.04 13.90 2406 423538 908269 109255086
Wound infection 193.34 13.90 65 425879 96400 110066955
Injection site swelling 193.23 13.90 11 425933 61779 110101576
Suicidal ideation 192.32 13.90 61 425883 93876 110069479
Alanine aminotransferase increased 188.67 13.90 259 425685 183514 109979841
Hypoglycaemia 185.87 13.90 108 425836 115996 110047359
Protein total increased 184.64 13.90 150 425794 4574 110158781
Incorrect route of product administration 184.32 13.90 17 425927 64044 110099311
Red blood cell sedimentation rate increased 182.89 13.90 39 425905 78263 110085092
Epilepsy 181.76 13.90 79 425865 100130 110063225
Pathological fracture 181.65 13.90 228 425716 11804 110151551
Sleep disorder due to a general medical condition 181.10 13.90 4 425940 52108 110111247
Incorrect dose administered 178.23 13.90 88 425856 103553 110059802
Malignant melanoma 177.94 13.90 269 425675 16622 110146733
SARS-CoV-2 test positive 177.41 13.90 269 425675 16666 110146689
Stress 174.40 13.90 94 425850 105254 110058101
Blood creatine phosphokinase increased 173.57 13.90 35 425909 73042 110090313
Underdose 172.27 13.90 21 425923 63533 110099822
Arthropathy 170.76 13.90 553 425391 286969 109876386
Hip arthroplasty 168.39 13.90 12 425932 55801 110107554
Metabolic acidosis 166.59 13.90 88 425856 99656 110063699
Gallbladder disorder 166.07 13.90 294 425650 20735 110142620
Bone erosion 163.38 13.90 3 425941 46368 110116987
Injection site bruising 160.69 13.90 9 425935 51254 110112101
Joint swelling 159.72 13.90 1024 424920 441821 109721534
Gout 159.51 13.90 401 425543 36165 110127190
Stomatitis 158.24 13.90 523 425421 269719 109893636
Blepharospasm 156.63 13.90 15 425929 54836 110108519
Hiccups 155.98 13.90 219 425725 12650 110150705
Bone lesion 155.60 13.90 163 425781 6924 110156431
Full blood count increased 152.85 13.90 69 425875 681 110162674
Gastrooesophageal reflux disease 152.42 13.90 288 425656 179688 109983667
Infection 151.28 13.90 2092 423852 360108 109803247
Acute leukaemia 150.53 13.90 92 425852 1757 110161598
Dysgeusia 148.18 13.90 598 425346 69387 110093968
Drug level increased 147.68 13.90 9 425935 47710 110115645
Coeliac disease 147.46 13.90 4 425940 43183 110120172
Injection site pruritus 146.42 13.90 14 425930 51244 110112111
Agitation 145.99 13.90 132 425812 112919 110050436
Dislocation of vertebra 145.84 13.90 5 425939 43716 110119639
Back pain 145.82 13.90 2120 423824 368876 109794479
Bradycardia 141.47 13.90 238 425706 155279 110008076
Cellulitis 141.32 13.90 900 425044 125116 110038239
Pregnancy 140.58 13.90 16 425928 51051 110112304
Myocardial infarction 140.01 13.90 1239 424705 190844 109972511
Electrocardiogram QT prolonged 139.78 13.90 128 425816 108832 110054523
Lactic acidosis 139.33 13.90 93 425851 92718 110070637
Swelling 138.47 13.90 789 425155 350252 109813103
Pulmonary fibrosis 138.02 13.90 114 425830 101928 110061427
Osteonecrosis of jaw 136.95 13.90 452 425492 47565 110115790
Nail disorder 135.01 13.90 29 425915 57906 110105449
Hyperkalaemia 134.78 13.90 196 425748 135600 110027755
Blood pressure fluctuation 132.53 13.90 61 425883 74763 110088592
Spinal compression fracture 132.38 13.90 247 425697 18145 110145210
Clostridium difficile infection 131.46 13.90 471 425473 51658 110111697
Obstructive airways disorder 130.78 13.90 13 425931 46136 110117219
Stem cell transplant 129.27 13.90 119 425825 4308 110159047
Hordeolum 128.30 13.90 124 425820 4777 110158578
Drug withdrawal syndrome 128.19 13.90 4 425940 38050 110125305
Drug ineffective for unapproved indication 128.17 13.90 124 425820 102714 110060641
Therapy partial responder 128.08 13.90 373 425571 36688 110126667
Sciatica 127.75 13.90 101 425843 92298 110071057
Upper limb fracture 126.65 13.90 261 425683 20627 110142728
Hepatic cirrhosis 126.36 13.90 51 425893 67575 110095780
Rib fracture 124.61 13.90 348 425596 33422 110129933
Dementia 122.44 13.90 332 425612 31341 110132014
Dry mouth 121.17 13.90 381 425563 199567 109963788
Osteoporosis 120.83 13.90 95 425849 87057 110076298
Lung disorder 120.80 13.90 327 425617 179720 109983635
Decreased appetite 119.00 13.90 2530 423414 473316 109690039
Respiratory syncytial virus infection 118.92 13.90 206 425738 14278 110149077
Foot deformity 117.71 13.90 22 425922 48458 110114897
Hepatitis 117.65 13.90 104 425840 89950 110073405
Onychomadesis 116.88 13.90 18 425926 45645 110117710
Malignant neoplasm of unknown primary site 116.64 13.90 58 425886 723 110162632
Abdominal discomfort 115.82 13.90 965 424979 392893 109770462
Malignant neoplasm progression 115.56 13.90 1103 424841 173464 109989891
Polyneuropathy 115.29 13.90 327 425617 31685 110131670
Confusional state 115.19 13.90 1201 424743 467479 109695876
Monoclonal immunoglobulin increased 113.60 13.90 53 425891 568 110162787
Delirium 113.50 13.90 217 425727 134808 110028547
Fracture 112.50 13.90 276 425668 24512 110138843
Emotional distress 111.82 13.90 19 425925 44828 110118527
Somnolence 111.72 13.90 679 425265 296770 109866585
Pallor 111.50 13.90 39 425905 56428 110106927
Frequent bowel movements 110.62 13.90 69 425875 71321 110092034
Ascites 109.86 13.90 117 425827 92691 110070664
Angioedema 108.10 13.90 132 425812 98368 110064987
Intentional self-injury 107.50 13.90 10 425934 37419 110125936
Retinitis 106.78 13.90 4 425940 32323 110131032
Anaphylactic shock 106.35 13.90 33 425911 51513 110111842
Finger deformity 106.28 13.90 5 425939 33087 110130268
Accidental exposure to product 105.01 13.90 31 425913 49977 110113378
Leukaemia 104.90 13.90 137 425807 7381 110155974
Palpitations 104.69 13.90 292 425652 158920 110004435
Localised infection 104.36 13.90 384 425560 42664 110120691
Premature delivery 103.98 13.90 3 425941 30629 110132726
Arthritis 103.90 13.90 316 425628 167270 109996085
Respiratory arrest 102.52 13.90 48 425896 58251 110105104
Swelling face 101.43 13.90 656 425288 91665 110071690
Myoclonus 99.82 13.90 7 425937 32991 110130364
Dysarthria 99.62 13.90 106 425838 84015 110079340
Exostosis 99.26 13.90 27 425917 45929 110117426
Pneumonia influenzal 99.10 13.90 96 425848 3709 110159646
Pregnancy test false positive 98.68 13.90 34 425910 148 110163207
Coronavirus infection 97.70 13.90 150 425794 9395 110153960
Blood magnesium decreased 97.59 13.90 229 425715 19767 110143588
Extrapyramidal disorder 97.36 13.90 3 425941 28864 110134491
Diverticulitis 96.80 13.90 436 425508 53086 110110269
Blood test abnormal 96.39 13.90 285 425659 28269 110135086
Poisoning 94.78 13.90 4 425940 29101 110134254
Onychomycosis 94.59 13.90 17 425927 38514 110124841
Erythema 94.54 13.90 695 425249 290752 109872603
Haematotoxicity 93.84 13.90 233 425711 20849 110142506
Gait disturbance 93.36 13.90 657 425287 277551 109885804
Disability 92.63 13.90 6 425938 30217 110133138
Compression fracture 92.19 13.90 144 425800 9155 110154200
Illness 91.57 13.90 586 425358 81585 110081770
Withdrawal syndrome 91.16 13.90 8 425936 31372 110131983
Respiratory depression 90.72 13.90 9 425935 31992 110131363
Hallucination, visual 89.92 13.90 21 425923 39584 110123771
Gastric disorder 88.94 13.90 307 425637 33050 110130305
Tremor 88.82 13.90 1179 424765 201053 109962302
Generalised tonic-clonic seizure 88.74 13.90 50 425894 54630 110108725
Joint stiffness 88.63 13.90 77 425867 67166 110096189
Transient ischaemic attack 88.52 13.90 483 425461 63499 110099856
Upper respiratory tract infection 88.49 13.90 833 425111 130495 110032860
Lung adenocarcinoma 88.18 13.90 143 425801 9388 110153967
Therapeutic response shortened 87.43 13.90 7 425937 29576 110133779
Injection site haemorrhage 86.90 13.90 12 425932 33016 110130339
Respiratory tract infection 86.87 13.90 522 425422 71095 110092260
Procedural pain 86.64 13.90 16 425928 35549 110127806
Abortion spontaneous 86.64 13.90 14 425930 34268 110129087
Cardiac amyloidosis 86.24 13.90 78 425866 2759 110160596
Surgery 85.94 13.90 26 425918 41257 110122098
Viral infection 85.21 13.90 418 425526 52721 110110634
Breast cancer stage II 85.21 13.90 5 425939 27370 110135985
Body temperature decreased 85.03 13.90 19 425925 36916 110126439
Myositis 85.02 13.90 10 425934 31106 110132249
Dermatitis atopic 84.91 13.90 3 425941 25538 110137817
Device dislocation 84.65 13.90 11 425933 31693 110131662
Therapy change 84.46 13.90 144 425800 9853 110153502
Visceral leishmaniasis 84.36 13.90 63 425881 1693 110161662
Prescribed underdose 84.25 13.90 76 425868 65098 110098257
Amyloidosis 84.25 13.90 81 425863 3100 110160255
Squamous cell carcinoma 84.24 13.90 206 425738 18257 110145098
Aggression 84.04 13.90 63 425881 59147 110104208
Rash macular 83.83 13.90 333 425611 38353 110125002
Gamma-glutamyltransferase increased 83.52 13.90 68 425876 61241 110102114
Septic shock 83.28 13.90 951 424993 156577 110006778
Chest discomfort 82.62 13.90 366 425578 173482 109989873
Pyrexia 82.54 13.90 4239 421705 894026 109269329
Spinal disorder 82.53 13.90 156 425788 11572 110151783
Bone marrow failure 82.27 13.90 440 425504 57408 110105947
Dyskinesia 82.12 13.90 48 425896 51398 110111957
Road traffic accident 81.47 13.90 183 425761 107215 110056140
Seizure 81.41 13.90 508 425436 220677 109942678
Interstitial lung disease 81.27 13.90 270 425674 139064 110024291
Back disorder 80.56 13.90 219 425725 20703 110142652
Abnormal behaviour 80.53 13.90 25 425919 39014 110124341
Eczema 80.26 13.90 96 425848 72197 110091158
White blood cell count increased 80.20 13.90 157 425787 96685 110066670
Diabetic ketoacidosis 79.75 13.90 31 425913 42027 110121328
Depressed mood 79.70 13.90 70 425874 60739 110102616
Blood pressure diastolic decreased 79.57 13.90 20 425924 35865 110127490
Dyspepsia 79.18 13.90 422 425522 190543 109972812
Atrial flutter 77.97 13.90 238 425706 24024 110139331
Muscular weakness 77.49 13.90 599 425345 247869 109915486
Flushing 77.40 13.90 181 425763 104555 110058800
Pneumonia respiratory syncytial viral 76.61 13.90 72 425872 2677 110160678
Immune system disorder 76.39 13.90 164 425780 13337 110150018
Product prescribing error 76.28 13.90 52 425892 51279 110112076
Impaired work ability 76.03 13.90 7 425937 26412 110136943
Lactose intolerance 76.01 13.90 72 425872 2704 110160651
Muscle rigidity 76 13.90 4 425940 24027 110139328
White blood cell count abnormal 75.58 13.90 112 425832 6797 110156558
Skin cancer 75.45 13.90 193 425751 17591 110145764
Intentional product use issue 75.36 13.90 1358 424586 246548 109916807
Myelodysplastic syndrome transformation 75.21 13.90 44 425900 773 110162582
Product dispensing issue 73.12 13.90 40 425904 614 110162741
Transaminases increased 72.72 13.90 82 425862 63308 110100047
Liver disorder 72.19 13.90 292 425652 141951 110021404
Clostridium difficile colitis 72.09 13.90 347 425597 43431 110119924
Hepatic steatosis 71.86 13.90 50 425894 48781 110114574
Refractory anaemia with an excess of blasts 71.15 13.90 43 425901 804 110162551
Tumour lysis syndrome 70.71 13.90 270 425674 30531 110132824
International normalised ratio increased 69.86 13.90 143 425801 86629 110076726
Blood alkaline phosphatase increased 69.77 13.90 103 425841 70832 110092523
Ventricular fibrillation 69.64 13.90 36 425908 41277 110122078
Motor dysfunction 68.83 13.90 7 425937 24399 110138956
Dystonia 68.78 13.90 9 425935 25796 110137559
Walking aid user 68.66 13.90 8 425936 25067 110138288
Treatment delayed 67.97 13.90 35 425909 472 110162883
Cardio-respiratory arrest 67.87 13.90 224 425720 115612 110047743
Hyperviscosity syndrome 67.19 13.90 36 425908 529 110162826
Oedema 66.98 13.90 503 425441 209473 109953882
Rectal adenocarcinoma 66.79 13.90 54 425890 1635 110161720
Refractory cytopenia with multilineage dysplasia 65.96 13.90 28 425916 235 110163120
Melaena 65.54 13.90 102 425842 68655 110094700
Sputum discoloured 65.09 13.90 14 425930 27931 110135424
Neutrophil count increased 64.95 13.90 26 425918 34626 110128729
Neutrophil count abnormal 64.69 13.90 89 425855 5043 110158312
Hypogammaglobulinaemia 64.57 13.90 197 425747 19879 110143476
Psychotic disorder 63.95 13.90 61 425883 50876 110112479
Status epilepticus 63.73 13.90 21 425923 31550 110131805
Heart rate increased 63.50 13.90 311 425633 143523 110019832
Hemiparesis 63.23 13.90 46 425898 43857 110119498
Drug intolerance 62.61 13.90 1145 424799 405367 109757988
Tubulointerstitial nephritis 62.51 13.90 70 425874 54214 110109141
Hepatotoxicity 62.41 13.90 92 425852 63308 110100047
Hypogeusia 62.33 13.90 58 425886 2129 110161226
Transplant rejection 62.16 13.90 10 425934 24557 110138798
Poor venous access 62.00 13.90 10 425934 24512 110138843
Multiple sclerosis 61.67 13.90 12 425932 25686 110137669
Cytokine release syndrome 61.66 13.90 473 425471 69833 110093522
Spinal cord compression 61.47 13.90 107 425837 7445 110155910
Gait inability 61.30 13.90 293 425651 136083 110027272
Bronchiectasis 61.21 13.90 32 425912 36461 110126894
Intraductal proliferative breast lesion 60.56 13.90 65 425879 2840 110160515
Back injury 60.40 13.90 56 425888 47343 110116012
Blood electrolytes decreased 60.24 13.90 52 425892 1727 110161628
Coordination abnormal 60.08 13.90 12 425932 25216 110138139
Liver function test increased 59.99 13.90 160 425784 88388 110074967
Feeling hot 59.94 13.90 167 425777 90939 110072416
Blood pressure diastolic increased 59.89 13.90 3 425941 18804 110144551
Oedema peripheral 59.88 13.90 1674 424270 326986 109836369
Tachypnoea 59.76 13.90 39 425905 39356 110123999
Fear 59.68 13.90 9 425935 23184 110140171
Unresponsive to stimuli 59.51 13.90 96 425848 63694 110099661
Device malfunction 59.13 13.90 13 425931 25545 110137810
Product administration error 59.01 13.90 35 425909 37182 110126173
Hypothyroidism 58.80 13.90 120 425824 72779 110090576
Light chain analysis abnormal 58.77 13.90 25 425919 211 110163144
Hepatocellular injury 58.65 13.90 65 425879 50577 110112778
Myasthenia gravis 58.56 13.90 7 425937 21504 110141851
Pelvic fracture 58.39 13.90 152 425792 14002 110149353
Malignant melanoma in situ 58.12 13.90 70 425874 3472 110159883
Torsade de pointes 57.63 13.90 9 425935 22591 110140764
Pemphigoid 57.31 13.90 5 425939 19702 110143653
Colon cancer 57.30 13.90 166 425778 16277 110147078
Failure to thrive 57.26 13.90 147 425797 13427 110149928
Blood immunoglobulin G increased 57.23 13.90 72 425872 3736 110159619
Malaise 56.15 13.90 2069 423875 669750 109493605
Night sweats 56.13 13.90 295 425649 133688 110029667
Chronic sinusitis 55.58 13.90 14 425930 25070 110138285
Endometrial adenocarcinoma 55.57 13.90 43 425901 1220 110162135
Accidental overdose 55.26 13.90 71 425873 51763 110111592
Chondrocalcinosis pyrophosphate 55.13 13.90 48 425896 1613 110161742
Multiple allergies 55.07 13.90 136 425808 12127 110151228
Hypokinesia 54.96 13.90 9 425935 21817 110141538
Schizophrenia 54.96 13.90 9 425935 21817 110141538
Seasonal allergy 54.76 13.90 184 425760 19538 110143817
Injection site warmth 54.72 13.90 3 425941 17402 110145953
Rales 54.44 13.90 14 425930 24725 110138630
Rectal haemorrhage 54.12 13.90 257 425687 119576 110043779
Sinus tachycardia 53.88 13.90 55 425889 44438 110118917
Arteriosclerosis coronary artery 53.79 13.90 15 425929 25103 110138252
Febrile neutropenia 53.73 13.90 1599 424345 315168 109848187
Eye infection 52.96 13.90 149 425795 14369 110148986
Invasive ductal breast carcinoma 52.58 13.90 93 425851 6553 110156802
Activated partial thromboplastin time prolonged 52.52 13.90 11 425933 22357 110140998
Sleep apnoea syndrome 52.48 13.90 47 425897 40400 110122955
Uveitis 52.39 13.90 10 425934 21700 110141655
Leukocytosis 52.12 13.90 79 425865 53749 110109606
Upper gastrointestinal haemorrhage 51.99 13.90 70 425874 50026 110113329
Primary amyloidosis 51.93 13.90 25 425919 289 110163066
Blood urea increased 51.93 13.90 82 425862 54875 110108480
Parkinsonism 51.91 13.90 11 425933 22176 110141179
Cholestasis 51.36 13.90 107 425837 64411 110098944
Peripheral sensory neuropathy 51.17 13.90 161 425783 16519 110146836
Injection site urticaria 51.08 13.90 4 425940 17211 110146144
Glycosylated haemoglobin increased 50.78 13.90 14 425930 23605 110139750
Haematemesis 50.53 13.90 94 425850 59014 110104341
Metastases to bone 50.46 13.90 29 425915 31343 110132012
Cyanosis 50.00 13.90 26 425918 29715 110133640
Febrile infection 49.95 13.90 73 425871 4375 110158980
Adenocarcinoma pancreas 49.59 13.90 52 425892 2211 110161144
Eye swelling 49.49 13.90 255 425689 32793 110130562
Delusion 49.38 13.90 15 425929 23740 110139615
Normal newborn 48.94 13.90 12 425932 21884 110141471
Prostatic disorder 48.58 13.90 54 425890 2455 110160900
Female genital tract fistula 48.56 13.90 4 425940 16515 110146840
Hyperlipidaemia 48.53 13.90 40 425904 35808 110127547
Transformation to acute myeloid leukaemia 48.53 13.90 43 425901 1480 110161875
Uterine disorder 48.41 13.90 52 425892 2274 110161081
Pulmonary arterial hypertension 48.38 13.90 33 425911 32535 110130820
Diffuse large B-cell lymphoma recurrent 48.37 13.90 87 425857 6212 110157143
Vaginal discharge 48.33 13.90 6 425938 17902 110145453
Hernia 48.15 13.90 175 425769 19325 110144030
Impaired quality of life 47.92 13.90 28 425916 29989 110133366
Tenosynovitis 47.71 13.90 4 425940 16279 110147076
Bile acid malabsorption 47.56 13.90 27 425917 447 110162908
Proctitis 47.36 13.90 5 425939 16922 110146433
Metastases to liver 47.27 13.90 40 425904 35346 110128009
Hypothermia 47.27 13.90 21 425923 26281 110137074
White blood cell disorder 47.26 13.90 66 425878 3793 110159562
Pancreatitis acute 47.11 13.90 101 425843 60173 110103182
Parainfluenzae virus infection 46.90 13.90 91 425853 6883 110156472
Respiratory rate increased 46.72 13.90 19 425925 25064 110138291
Hallucination 46.71 13.90 216 425728 101216 110062139
Infusion site pain 46.61 13.90 6 425938 17413 110145942
Blood disorder 46.41 13.90 111 425833 9699 110153656
Musculoskeletal chest pain 46.31 13.90 227 425717 28620 110134735
Incorrect product administration duration 46.28 13.90 11 425933 20487 110142868
Aplastic anaemia 45.95 13.90 18 425926 24290 110139065
Hepatic encephalopathy 45.61 13.90 26 425918 28230 110135125
Crying 45.22 13.90 21 425923 25607 110137748
Therapy cessation 45.20 13.90 312 425632 44545 110118810
Body height decreased 45.19 13.90 115 425829 10448 110152907
Bladder transitional cell carcinoma 45.14 13.90 55 425889 2761 110160594
Paranoia 44.96 13.90 15 425929 22359 110140996
Immune reconstitution inflammatory syndrome 44.87 13.90 5 425939 16221 110147134
Blood triglycerides increased 44.76 13.90 18 425926 23908 110139447
Platelet count abnormal 44.75 13.90 84 425860 6198 110157157
Altered state of consciousness 44.68 13.90 97 425847 57529 110105826
Performance status decreased 44.30 13.90 91 425853 7175 110156180
Iron deficiency anaemia 44.25 13.90 34 425910 31525 110131830
Pneumonia pneumococcal 43.92 13.90 73 425871 4892 110158463
Hypoxia 43.83 13.90 305 425639 129210 110034145
Nightmare 43.78 13.90 51 425893 38812 110124543
Platelet disorder 43.74 13.90 62 425882 3613 110159742
Cardiac murmur 43.73 13.90 20 425924 24608 110138747
Circumstance or information capable of leading to medication error 43.71 13.90 75 425869 5158 110158197
Cardiogenic shock 43.24 13.90 98 425846 57240 110106115
Neck pain 43.14 13.90 287 425657 122843 110040512
Traumatic fracture 43.10 13.90 36 425908 1142 110162213
Hallucination, auditory 43.03 13.90 24 425920 26373 110136982
Myeloma cast nephropathy 42.93 13.90 21 425923 252 110163103
Concomitant disease aggravated 42.92 13.90 6 425938 16358 110146997
Blood phosphorus increased 42.84 13.90 6 425938 16334 110147021
Rash maculo-papular 42.83 13.90 456 425488 73766 110089589
Lower limb fracture 42.57 13.90 148 425796 75200 110088155
Adenocarcinoma gastric 42.43 13.90 46 425898 2033 110161322
Haematuria 42.36 13.90 170 425774 82835 110080520
Laryngitis 42.28 13.90 61 425883 42350 110121005
Affect lability 42.08 13.90 10 425934 18627 110144728
Anhedonia 42.05 13.90 5 425939 15423 110147932
Toxic epidermal necrolysis 41.93 13.90 98 425846 56629 110106726
Restlessness 41.74 13.90 97 425847 56162 110107193
Circulatory collapse 41.72 13.90 63 425881 42930 110120425
Shock 41.72 13.90 90 425854 53498 110109857
Swollen tongue 41.70 13.90 108 425836 60254 110103101
Rhinitis allergic 41.70 13.90 9 425935 17913 110145442
Coagulopathy 41.62 13.90 58 425886 40853 110122502
Salmonellosis 41.46 13.90 47 425897 2184 110161171
Proteinuria 41.45 13.90 56 425888 39962 110123393
Exposure via body fluid 40.84 13.90 22 425922 327 110163028
Pustular psoriasis 40.82 13.90 3 425941 13602 110149753
Drug tolerance decreased 40.79 13.90 28 425916 27512 110135843
Encephalopathy 40.74 13.90 167 425777 80888 110082467
Dizziness 40.41 13.90 3167 422777 695026 109468329
Right ventricular failure 40.32 13.90 25 425919 25929 110137426
Adrenal insufficiency 40.29 13.90 63 425881 42327 110121028
Brain oedema 39.32 13.90 37 425907 31061 110132294
Hypoaesthesia 39.30 13.90 1531 424413 312692 109850663
Paraproteinaemia 39.20 13.90 25 425919 516 110162839
Middle insomnia 39.06 13.90 15 425929 20487 110142868
Breath sounds abnormal 38.74 13.90 25 425919 25379 110137976
Electrocardiogram QRS complex prolonged 38.71 13.90 3 425941 13018 110150337
Respiratory tract infection viral 38.68 13.90 76 425868 5802 110157553
Pneumonia parainfluenzae viral 38.58 13.90 27 425917 654 110162701
Hyperphosphataemia 38.58 13.90 8 425936 16373 110146982
Cervical vertebral fracture 38.47 13.90 66 425878 4539 110158816
Metastases to lymph nodes 38.30 13.90 6 425938 15026 110148329
Venous thrombosis limb 38.25 13.90 71 425873 5194 110158161
Blood loss anaemia 38.16 13.90 11 425933 18014 110145341
Diabetes mellitus inadequate control 38.15 13.90 35 425909 29740 110133615
Blood immunoglobulin A increased 37.93 13.90 38 425906 1530 110161825
Pneumonia legionella 37.82 13.90 57 425887 3512 110159843
Blood calcium abnormal 37.61 13.90 40 425904 1729 110161626
Autoimmune hepatitis 37.51 13.90 6 425938 14798 110148557
Viral upper respiratory tract infection 37.46 13.90 105 425839 10103 110153252
Shock haemorrhagic 37.38 13.90 30 425914 27217 110136138
Basosquamous carcinoma of skin 37.35 13.90 10 425934 13 110163342
Myelosuppression 37.33 13.90 540 425404 93800 110069555
Joint dislocation 37.31 13.90 46 425898 34144 110129211
Ventricular tachycardia 37.28 13.90 86 425858 49923 110113432
Blood bilirubin increased 37.27 13.90 158 425786 75814 110087541
Colon cancer metastatic 37.13 13.90 47 425897 2454 110160901
Product prescribing issue 37.11 13.90 121 425823 12651 110150704
Neuralgic amyotrophy 37.08 13.90 21 425923 346 110163009
Pancreatitis 36.94 13.90 210 425734 93323 110070032
Red cell distribution width increased 36.80 13.90 11 425933 17591 110145764
Product physical issue 36.70 13.90 68 425876 4968 110158387
Nodule 36.57 13.90 43 425901 32588 110130767
Pulmonary hypertension 36.49 13.90 101 425843 55119 110108236
Campylobacter gastroenteritis 36.46 13.90 41 425903 1888 110161467
Hypotonia 36.44 13.90 8 425936 15737 110147618
Leukopenia 36.41 13.90 789 425155 148002 110015353
Colorectal adenocarcinoma 36.34 13.90 24 425920 527 110162828
Progressive multifocal leukoencephalopathy 36.29 13.90 191 425753 24765 110138590
TP53 gene mutation 36.25 13.90 16 425928 149 110163206
Panic attack 35.93 13.90 35 425909 28905 110134450
Acute hepatic failure 35.81 13.90 53 425891 36415 110126940
Therapeutic response unexpected 35.63 13.90 24 425920 23819 110139536
Hyperthyroidism 35.62 13.90 36 425908 29225 110134130
Haemodynamic instability 35.62 13.90 22 425922 22866 110140489
Exposure to toxic agent 35.46 13.90 4 425940 12854 110150501
Pneumonia viral 35.43 13.90 109 425835 11048 110152307
Speech disorder 35.42 13.90 120 425824 61449 110101906
No adverse event 35.34 13.90 155 425789 73684 110089671
Dyslipidaemia 35.20 13.90 9 425935 15956 110147399
Neoplasm skin 35.14 13.90 52 425892 3152 110160203
Productive cough 34.94 13.90 277 425667 114028 110049327
Blood calcium decreased 34.75 13.90 247 425697 35598 110127757
Skin fissures 34.74 13.90 26 425918 24432 110138923
Blood lactic acid increased 34.73 13.90 9 425935 15812 110147543
IVth nerve paralysis 34.72 13.90 25 425919 634 110162721
Pregnancy of partner 34.66 13.90 19 425925 293 110163062
Lymphocytic leukaemia 34.60 13.90 19 425925 294 110163061
Agranulocytosis 34.43 13.90 122 425822 61638 110101717
Hepatic failure 34.31 13.90 142 425802 68597 110094758
Nasal polyps 34.25 13.90 5 425939 13195 110150160
Disturbance in attention 34.20 13.90 123 425821 61872 110101483
Enthesopathy 34.12 13.90 4 425940 12474 110150881
Prostate cancer 33.99 13.90 255 425689 37386 110125969
Nasal congestion 33.97 13.90 230 425714 98052 110065303
Hepatic cytolysis 33.97 13.90 104 425840 54949 110108406
Lentigo maligna 33.96 13.90 25 425919 657 110162698
Blood test 33.92 13.90 9 425935 11 110163344
Hypomagnesaemia 33.82 13.90 119 425825 60251 110103104
Normochromic normocytic anaemia 33.75 13.90 5 425939 13052 110150303
Cholecystitis infective 33.68 13.90 55 425889 3632 110159723
Throat tightness 33.55 13.90 48 425896 33441 110129914
Nystagmus 33.50 13.90 3 425941 11574 110151781
Nerve injury 33.41 13.90 104 425840 10609 110152746
Ear pain 33.23 13.90 100 425844 53126 110110229
Heparin-induced thrombocytopenia 32.95 13.90 3 425941 11421 110151934
Heavy menstrual bleeding 32.83 13.90 11 425933 16354 110147001
Eye disorder 32.72 13.90 207 425737 28699 110134656
Food allergy 32.71 13.90 18 425926 19930 110143425
Human chorionic gonadotropin abnormal 32.68 13.90 9 425935 14 110163341
Gastrointestinal infection 32.33 13.90 123 425821 13882 110149473
Rheumatoid nodule 32.30 13.90 19 425925 20277 110143078
Post procedural complication 32.22 13.90 33 425911 26625 110136730
Blood calcium increased 31.90 13.90 146 425798 17894 110145461
Injection site rash 31.86 13.90 26 425918 23393 110139962
Lymphoma 31.86 13.90 158 425786 20013 110143342
Vision blurred 31.83 13.90 685 425259 128337 110035018
Flatulence 31.80 13.90 324 425620 51825 110111530
Throat irritation 31.75 13.90 103 425841 53449 110109906
Product dispensing error 31.71 13.90 136 425808 16209 110147146
Jaundice 31.71 13.90 119 425825 59117 110104238
Inappropriate antidiuretic hormone secretion 31.52 13.90 51 425893 33800 110129555
Plasma cell myeloma in remission 31.40 13.90 10 425934 32 110163323
Transfusion 31.40 13.90 31 425913 25441 110137914
Polyarthritis 31.26 13.90 17 425927 18946 110144409
Abdominal distension 31.23 13.90 480 425464 174623 109988732
Increased tendency to bruise 31.16 13.90 108 425836 11650 110151705
Syncope 31.03 13.90 1010 424934 201526 109961829
Immunoglobulins decreased 30.84 13.90 42 425902 2357 110160998
Appendix disorder 30.79 13.90 37 425907 1831 110161524
Venous thrombosis 30.74 13.90 87 425857 8418 110154937
Tendonitis 30.73 13.90 33 425911 26050 110137305
Hepatitis B reactivation 30.49 13.90 80 425864 7404 110155951
Ovarian cyst 30.43 13.90 8 425936 13922 110149433
Lipase increased 30.40 13.90 17 425927 18655 110144700
Taste disorder 30.27 13.90 385 425559 65002 110098353
Injection site induration 30.27 13.90 4 425940 11379 110151976
Catatonia 29.98 13.90 4 425940 11296 110152059
Sarcoidosis 29.92 13.90 6 425938 12573 110150782
Intracranial pressure increased 29.76 13.90 3 425941 10532 110152823
Metastases to lung 29.68 13.90 27 425917 23036 110140319
Oral herpes 29.43 13.90 59 425885 36021 110127334
Hepatic function abnormal 29.37 13.90 212 425732 89083 110074272
Intestinal obstruction 29.32 13.90 324 425620 52903 110110452
Dyspnoea exertional 29.17 13.90 258 425686 103802 110059553
Squamous cell carcinoma of lung 29.15 13.90 44 425900 2715 110160640
Device occlusion 29.11 13.90 11 425933 15174 110148181
Skin exfoliation 29.07 13.90 487 425457 87164 110076191
Cholangiocarcinoma 29.05 13.90 45 425899 2840 110160515
Metastases to central nervous system 29.02 13.90 27 425917 22790 110140565
H1N1 influenza 28.90 13.90 46 425898 2972 110160383
Second primary malignancy 28.87 13.90 142 425802 17926 110145429
Clavicle fracture 28.87 13.90 64 425880 5320 110158035
Spinal operation 28.83 13.90 4 425940 10968 110152387
Pulmonary sepsis 28.59 13.90 63 425881 5215 110158140
Cardiac failure 28.58 13.90 935 425009 186691 109976664
Bone density decreased 28.53 13.90 13 425931 16029 110147326
Immune-mediated enterocolitis 28.52 13.90 3 425941 10182 110153173
Squamous cell carcinoma of the hypopharynx 28.47 13.90 8 425936 14 110163341
Bone marrow disorder 28.27 13.90 55 425889 4168 110159187
Acidosis 28.26 13.90 27 425917 22504 110140851
Ketoacidosis 28.17 13.90 3 425941 10084 110153271
Creatinine renal clearance abnormal 28.04 13.90 23 425921 711 110162644
Muscle twitching 27.97 13.90 45 425899 29890 110133465
Neuroendocrine carcinoma of the skin 27.84 13.90 34 425910 1711 110161644
Low density lipoprotein increased 27.77 13.90 4 425940 10662 110152693
Tenderness 27.74 13.90 44 425900 29393 110133962
Electrocardiogram abnormal 27.74 13.90 19 425925 18690 110144665
Vertebral lesion 27.73 13.90 22 425922 648 110162707
White blood cell count 27.73 13.90 15 425929 225 110163130
Complication associated with device 27.67 13.90 22 425922 20051 110143304
Liver function test abnormal 27.67 13.90 154 425790 68796 110094559
Sinusitis 27.66 13.90 901 425043 295787 109867568
Kidney infection 27.56 13.90 181 425763 25418 110137937
Tardive dyskinesia 27.47 13.90 9 425935 13570 110149785
Product supply issue 27.44 13.90 51 425893 3735 110159620
Product storage error 27.30 13.90 26 425918 21702 110141653
Morganella infection 27.25 13.90 30 425914 1349 110162006
Post transplant lymphoproliferative disorder 27.23 13.90 13 425931 15600 110147755
Drug resistance 27.18 13.90 118 425826 56256 110107099
Atypical pneumonia 27.04 13.90 79 425865 7783 110155572
Cytogenetic abnormality 27.02 13.90 28 425916 1174 110162181
Gastrointestinal stromal tumour 26.93 13.90 37 425907 2094 110161261
Scar 26.59 13.90 16 425928 16865 110146490
Cerebral haematoma 26.56 13.90 3 425941 9629 110153726
Pneumonia streptococcal 26.55 13.90 48 425896 3441 110159914
Bladder transitional cell carcinoma stage 0 26.53 13.90 12 425932 119 110163236
Superficial spreading melanoma stage unspecified 26.53 13.90 17 425927 354 110163001
POEMS syndrome 26.27 13.90 10 425934 61 110163294
Neoplasm 26.12 13.90 98 425846 10989 110152366
Asphyxia 26.10 13.90 11 425933 14204 110149151
Heart rate decreased 26.01 13.90 199 425745 82557 110080798
Neurotoxicity 25.85 13.90 80 425864 42127 110121228
Food poisoning 25.84 13.90 68 425876 6304 110157051
Iron deficiency 25.78 13.90 20 425924 18456 110144899
Breast cancer female 25.69 13.90 8 425936 12460 110150895
Hyperhidrosis 25.62 13.90 538 425406 186760 109976595
Protein total abnormal 25.61 13.90 22 425922 726 110162629
Mouth ulceration 25.58 13.90 97 425847 48041 110115314
Muscle strain 25.55 13.90 98 425846 11104 110152251
Cardiac valve disease 25.51 13.90 68 425876 6353 110157002
Bone disorder 25.40 13.90 154 425790 21038 110142317
Ear swelling 25.37 13.90 36 425908 2100 110161255
Anuria 25.27 13.90 34 425910 24307 110139048
Meningitis listeria 25.26 13.90 28 425916 1269 110162086
Movement disorder 25.25 13.90 65 425879 36339 110127016
Humerus fracture 25.18 13.90 95 425849 10681 110152674
Gastroenteritis viral 25.14 13.90 206 425738 31020 110132335
Light chain disease 25.13 13.90 15 425929 274 110163081
Bronchospasm 25.05 13.90 49 425895 30190 110133165
Urticaria 25.02 13.90 989 424955 317868 109845487
Weight fluctuation 25.01 13.90 29 425915 22116 110141239
Meningitis aseptic 25.01 13.90 4 425940 9866 110153489
Mucosal inflammation 24.95 13.90 243 425701 95898 110067457
Dissociation 24.91 13.90 4 425940 9838 110153517
Haematoma 24.91 13.90 128 425816 58348 110105007
Haemoptysis 24.65 13.90 167 425777 71187 110092168
Subretinal haematoma 24.64 13.90 9 425935 48 110163307
Toxic encephalopathy 24.56 13.90 14 425930 15200 110148155
Hypertriglyceridaemia 24.49 13.90 16 425928 16138 110147217
Type 1 diabetes mellitus 24.49 13.90 3 425941 9044 110154311
Feeling jittery 24.46 13.90 117 425827 14605 110148750
Hiatus hernia 24.40 13.90 43 425901 27563 110135792
Thrombophlebitis 24.37 13.90 75 425869 7604 110155751
Liver function test decreased 24.27 13.90 13 425931 191 110163164
Dyspnoea 24.23 13.90 3819 422125 1103053 109060302
Vascular device infection 24.17 13.90 17 425927 16495 110146860
Exfoliative rash 24.11 13.90 54 425890 4520 110158835
Hypopnoea 23.99 13.90 7 425937 11373 110151982
Bradykinesia 23.94 13.90 6 425938 10782 110152573
Diverticular perforation 23.90 13.90 66 425878 6296 110157059
Photophobia 23.83 13.90 39 425905 25732 110137623
General symptom 23.78 13.90 3 425941 8843 110154512
Dysphonia 23.77 13.90 418 425526 75511 110087844
Femur fracture 23.72 13.90 269 425675 44200 110119155
Chest pain 23.69 13.90 1196 424748 375179 109788176
SARS-CoV-2 sepsis 23.68 13.90 14 425930 251 110163104
Infection in an immunocompromised host 23.66 13.90 33 425911 1894 110161461
Pathogen resistance 23.57 13.90 20 425924 17652 110145703
Metastatic squamous cell carcinoma 23.52 13.90 21 425923 730 110162625
Oesophageal squamous cell carcinoma 23.41 13.90 18 425926 506 110162849
Precursor B-lymphoblastic lymphoma 23.38 13.90 7 425937 17 110163338
Respiratory acidosis 23.37 13.90 12 425932 13814 110149541
Rebound effect 23.37 13.90 14 425930 14792 110148563
Haematochezia 23.30 13.90 309 425635 115215 110048140
Head injury 23.30 13.90 261 425683 42756 110120599
Transitional cell carcinoma 23.30 13.90 43 425901 3132 110160223
Spinal osteoarthritis 23.26 13.90 26 425918 20157 110143198
Metabolic disorder 23.03 13.90 6 425938 10504 110152851
Spinal column injury 22.97 13.90 36 425908 2295 110161060
Atypical haemolytic uraemic syndrome 22.96 13.90 29 425915 1511 110161844
Chalazion 22.92 13.90 20 425924 674 110162681
Salivary hypersecretion 22.89 13.90 20 425924 17401 110145954
Skin plaque 22.87 13.90 10 425934 12635 110150720
Epstein-Barr virus infection 22.87 13.90 23 425921 18715 110144640
Philadelphia chromosome negative 22.83 13.90 7 425937 19 110163336
Psychiatric symptom 22.76 13.90 4 425940 9209 110154146
Blood stem cell harvest failure 22.71 13.90 11 425933 129 110163226
Exercise tolerance decreased 22.70 13.90 9 425935 12058 110151297
Tooth infection 22.66 13.90 155 425789 22061 110141294
Pneumonia bacterial 22.64 13.90 176 425768 26085 110137270
Wrong product administered 22.64 13.90 7 425937 10953 110152402
Injection site discolouration 22.38 13.90 4 425940 9099 110154256
Product preparation error 22.38 13.90 7 425937 10872 110152483
Gastroenteritis salmonella 22.28 13.90 27 425917 1348 110162007
Ataxia 22.26 13.90 52 425892 30056 110133299
Sensory loss 22.25 13.90 30 425914 21427 110141928
Left ventricular dysfunction 22.25 13.90 35 425909 23458 110139897
Haemoglobin abnormal 22.22 13.90 81 425863 8957 110154398
Behaviour disorder 22.13 13.90 5 425939 9642 110153713
Carotid artery thrombosis 22.10 13.90 5 425939 9633 110153722
Osteopenia 22.08 13.90 32 425912 22177 110141178
Vasculitis 21.96 13.90 68 425876 35805 110127550
Blood potassium abnormal 21.92 13.90 48 425896 3957 110159398
Ureteric haemorrhage 21.78 13.90 11 425933 142 110163213
Stupor 21.75 13.90 3 425941 8262 110155093
Ventricular hypokinesia 21.70 13.90 8 425936 11206 110152149
Mania 21.64 13.90 29 425915 20767 110142588
Granuloma 21.61 13.90 5 425939 9485 110153870
Oliguria 21.54 13.90 24 425920 18633 110144722
Hypercapnia 21.53 13.90 8 425936 11151 110152204
Visual impairment 21.49 13.90 376 425568 134052 110029303
Follicular lymphoma 21.47 13.90 20 425924 735 110162620
Aphasia 21.43 13.90 136 425808 58861 110104494
Skin necrosis 21.38 13.90 31 425913 21481 110141874
Product substitution issue 21.26 13.90 157 425787 22904 110140451
Hypertransaminasaemia 21.24 13.90 38 425906 24217 110139138
Vitamin B12 decreased 21.22 13.90 56 425888 5201 110158154
Acute erythroid leukaemia 21.12 13.90 15 425929 372 110162983
Lymphodepletion 21.12 13.90 8 425936 48 110163307
Radiculopathy 21.12 13.90 26 425918 19310 110144045
Palmar-plantar erythrodysaesthesia syndrome 20.94 13.90 84 425860 40941 110122414
Ulcer 20.94 13.90 90 425854 43026 110120329
Joint effusion 20.90 13.90 30 425914 20875 110142480
Urinary incontinence 20.89 13.90 106 425838 48481 110114874
Fistula 20.80 13.90 17 425927 15282 110148073
Systemic infection 20.77 13.90 6 425938 9813 110153542
Sternal fracture 20.77 13.90 42 425902 3274 110160081
Irritability 20.73 13.90 104 425840 47705 110115650
Subarachnoid haemorrhage 20.63 13.90 53 425891 29649 110133706
Autonomic neuropathy 20.59 13.90 34 425910 2266 110161089
Abdominal pain lower 20.55 13.90 74 425870 37209 110126146
Hepatitis fulminant 20.53 13.90 4 425940 8556 110154799
Mitral valve incompetence 20.53 13.90 63 425881 33266 110130089
Immunoglobulins increased 20.45 13.90 20 425924 782 110162573
Plasma cells increased 20.44 13.90 10 425934 120 110163235
Gastrointestinal disorder 20.40 13.90 744 425200 241208 109922147
Monocyte count increased 20.38 13.90 13 425931 13280 110150075
Dermatitis exfoliative generalised 20.30 13.90 90 425854 10882 110152473
Anger 20.30 13.90 26 425918 18981 110144374
Oral candidiasis 20.20 13.90 96 425848 44664 110118691
Drug effective for unapproved indication 20.20 13.90 15 425929 14152 110149203
Bradyphrenia 20.09 13.90 10 425934 11718 110151637
Deformity 20.09 13.90 7 425937 10153 110153202
Eye irritation 20.07 13.90 64 425880 33388 110129967
Depressive symptom 20.04 13.90 4 425940 8410 110154945
Rhinitis 20.03 13.90 35 425909 22510 110140845
Cerebellar haemangioma 20.01 13.90 9 425935 88 110163267
Aspiration bone marrow 19.99 13.90 11 425933 171 110163184
Dysphagia 19.91 13.90 445 425499 153155 110010200
N-terminal prohormone brain natriuretic peptide decreased 19.87 13.90 7 425937 33 110163322
Lung opacity 19.87 13.90 10 425934 11642 110151713
5q minus syndrome 19.86 13.90 13 425931 281 110163074
Hepatitis cholestatic 19.84 13.90 23 425921 17543 110145812
Invasive lobular breast carcinoma 19.79 13.90 20 425924 814 110162541
Transplant dysfunction 19.75 13.90 4 425940 8324 110155031
Mantle cell lymphoma recurrent 19.72 13.90 22 425922 1004 110162351
Pain in extremity 19.62 13.90 1612 424332 485506 109677849
Blood iron decreased 19.57 13.90 134 425810 19080 110144275
Disseminated intravascular coagulation 19.55 13.90 87 425857 41199 110122156
Hypophosphataemia 19.55 13.90 64 425880 33118 110130237
Blood stem cell harvest 19.53 13.90 7 425937 35 110163320
Duodenal ulcer 19.52 13.90 28 425916 19486 110143869
Tongue oedema 19.51 13.90 4 425940 8252 110155103
Epistaxis 19.41 13.90 648 425296 129724 110033631
Immunosuppression 19.38 13.90 126 425818 17633 110145722
Colitis microscopic 19.33 13.90 14 425930 13380 110149975
Renal oncocytoma 19.32 13.90 12 425932 236 110163119
Infusion site erythema 19.31 13.90 11 425933 11948 110151407
Thoracic vertebral fracture 19.29 13.90 63 425881 6592 110156763
Nail discolouration 19.25 13.90 43 425901 3592 110159763
Alanine aminotransferase abnormal 19.21 13.90 6 425938 9328 110154027
Hospice care 19.20 13.90 97 425847 12376 110150979
Angina unstable 19.12 13.90 21 425923 16411 110146944
Scoliosis 19.11 13.90 5 425939 8728 110154627
Neutropenic infection 19.03 13.90 40 425904 3205 110160150
Nasal abscess 18.97 13.90 11 425933 190 110163165
Arteriosclerosis 18.94 13.90 42 425902 24725 110138630
Blood thyroid stimulating hormone increased 18.90 13.90 12 425932 12289 110151066
Complications of transplanted kidney 18.89 13.90 3 425941 7439 110155916
Hepatic fibrosis 18.87 13.90 4 425940 8062 110155293
Gastric infection 18.83 13.90 47 425897 4219 110159136
Neutropenic sepsis 18.73 13.90 191 425753 30555 110132800
Eye movement disorder 18.73 13.90 7 425937 9721 110153634
Abortion induced 18.71 13.90 4 425940 8015 110155340
Electrocardiogram ST segment elevation 18.65 13.90 6 425938 9154 110154201
Stress cardiomyopathy 18.62 13.90 20 425924 15786 110147569
Oesophagitis 18.62 13.90 53 425891 28662 110134693
Angina pectoris 18.56 13.90 152 425792 62143 110101212
Red blood cell count abnormal 18.31 13.90 27 425917 1631 110161724
Breast cancer 18.29 13.90 228 425716 38314 110125041
Pleurisy viral 18.25 13.90 4 425940 0 110163355
Sickle cell anaemia with crisis 18.15 13.90 7 425937 9538 110153817
Bacteraemia 18.12 13.90 246 425698 42144 110121211
Device failure 18.08 13.90 3 425941 7204 110156151
Squamous cell carcinoma of the oral cavity 18.07 13.90 18 425926 720 110162635
JC virus infection 18.04 13.90 53 425891 5237 110158118
Abdominal tenderness 18.01 13.90 13 425931 12444 110150911
Kidney transplant rejection 18.00 13.90 12 425932 11975 110151380
Gynaecomastia 17.98 13.90 7 425937 9483 110153872
Sinus bradycardia 17.97 13.90 56 425888 29427 110133928
Bundle branch block left 17.92 13.90 14 425930 12874 110150481
Ear infection 17.82 13.90 155 425789 62577 110100778
Granulocyte count decreased 17.77 13.90 44 425900 3930 110159425
Enterococcal infection 17.75 13.90 32 425912 20334 110143021
Hepatitis B DNA increased 17.59 13.90 19 425925 836 110162519
Pneumothorax 17.54 13.90 73 425871 35212 110128143
Apnoea 17.51 13.90 16 425928 13623 110149732
Myocardial ischaemia 17.48 13.90 49 425895 26635 110136720
Skin haemorrhage 17.47 13.90 44 425900 24783 110138572
Gastritis 17.41 13.90 128 425816 53571 110109784
Oral infection 17.35 13.90 59 425885 6302 110157053
Dermatitis allergic 17.32 13.90 143 425801 21581 110141774
Large intestine infection 17.27 13.90 47 425897 4445 110158910
Corticobasal degeneration 17.25 13.90 6 425938 27 110163328
Aspiration 17.23 13.90 60 425884 30473 110132882
Blood magnesium abnormal 17.14 13.90 18 425926 767 110162588
Blood pressure decreased 17.12 13.90 326 425618 114765 110048590
Lung squamous cell carcinoma stage IV 17.11 13.90 7 425937 53 110163302
Hysterectomy 17.09 13.90 5 425939 8109 110155246
Laboratory test 17.08 13.90 6 425938 28 110163327
Therapeutic response decreased 17.04 13.90 265 425679 96234 110067121
Pre-eclampsia 17.03 13.90 6 425938 8644 110154711
Urosepsis 17.02 13.90 187 425757 30488 110132867
Methaemoglobinaemia 16.98 13.90 7 425937 9161 110154194
Blood pressure systolic decreased 16.98 13.90 16 425928 13425 110149930
Hyperaesthesia 16.94 13.90 19 425925 14708 110148647
Blood immunoglobulin E increased 16.92 13.90 4 425940 7478 110155877
Pseudomonas infection 16.91 13.90 53 425891 27800 110135555
Drug reaction with eosinophilia and systemic symptoms 16.89 13.90 425 425519 81670 110081685
Testicular disorder 16.89 13.90 13 425931 366 110162989
Varicophlebitis 16.89 13.90 7 425937 55 110163300
Refractory cytopenia with unilineage dysplasia 16.88 13.90 19 425925 876 110162479
Oral disorder 16.86 13.90 91 425853 11912 110151443
Nasal oedema 16.82 13.90 3 425941 6836 110156519
Blood chloride decreased 16.82 13.90 7 425937 9108 110154247
Oesophageal adenocarcinoma 16.81 13.90 20 425924 979 110162376
Intercepted product preparation error 16.76 13.90 3 425941 6817 110156538
Atrioventricular block first degree 16.75 13.90 18 425926 14207 110149148
Pigmentation disorder 16.71 13.90 64 425880 7247 110156108
Psychomotor hyperactivity 16.67 13.90 33 425911 20244 110143111
Skin hyperpigmentation 16.60 13.90 72 425872 8624 110154731
Wound dehiscence 16.60 13.90 5 425939 7957 110155398
Body temperature increased 16.53 13.90 133 425811 54580 110108775
Marasmus 16.51 13.90 26 425918 1665 110161690
Blood pressure abnormal 16.50 13.90 145 425799 22279 110141076
Cholecystitis chronic 16.43 13.90 8 425936 9492 110153863
Proctalgia 16.40 13.90 16 425928 13206 110150149
Enterocolitis bacterial 16.38 13.90 17 425927 714 110162641
Rash erythematous 16.36 13.90 422 425522 81410 110081945
Hemiplegia 16.33 13.90 40 425904 22742 110140613
Toxic skin eruption 16.32 13.90 170 425774 27345 110136010
Full blood count 16.26 13.90 7 425937 61 110163294
Balance disorder 16.26 13.90 575 425369 115985 110047370
Polyuria 16.26 13.90 27 425917 17711 110145644
Lumbar vertebral fracture 16.22 13.90 74 425870 9057 110154298
Haemodialysis 16.21 13.90 27 425917 17692 110145663
Wheelchair user 16.21 13.90 5 425939 7837 110155518
Maternal exposure before pregnancy 16.20 13.90 4 425940 7261 110156094
Spondylitis 16.17 13.90 12 425932 11326 110152029
Inflammatory bowel disease 16.10 13.90 4 425940 7230 110156125
Asymptomatic COVID-19 16.10 13.90 11 425933 256 110163099
Upper respiratory tract inflammation 16.08 13.90 45 425899 4326 110159029
Lymphoproliferative disorder 16.05 13.90 4 425940 7214 110156141
Thrombotic thrombocytopenic purpura 16.04 13.90 62 425882 7049 110156306
Pulse absent 16.04 13.90 12 425932 11280 110152075
Sepsis pasteurella 16.03 13.90 4 425940 3 110163352
Plasmacytosis 16 13.90 10 425934 199 110163156
Cholecystectomy 15.99 13.90 11 425933 10798 110152557
Transitional cell cancer of the renal pelvis and ureter 15.97 13.90 7 425937 64 110163291
Furuncle 15.96 13.90 71 425873 8597 110154758
Pulmonary oedema 15.94 13.90 504 425440 100155 110063200
JC virus CSF test positive 15.91 13.90 10 425934 201 110163154
Escherichia sepsis 15.90 13.90 80 425864 10192 110153163
Eosinophil count increased 15.87 13.90 36 425908 21022 110142333
Coronary artery disease 15.86 13.90 188 425756 71502 110091853
Sinus congestion 15.78 13.90 62 425882 30397 110132958
Vertebral wedging 15.71 13.90 6 425938 37 110163318
Total lung capacity decreased 15.70 13.90 4 425940 7110 110156245
Renal neoplasm 15.70 13.90 31 425913 2375 110160980
Bone marrow infiltration 15.65 13.90 18 425926 850 110162505
Frustration tolerance decreased 15.64 13.90 7 425937 8724 110154631
Coombs indirect test positive 15.60 13.90 7 425937 68 110163287
Platelet distribution width decreased 15.57 13.90 6 425938 38 110163317
Eye pruritus 15.56 13.90 69 425875 32706 110130649
Pulmonary function test decreased 15.55 13.90 7 425937 8693 110154662
Eyelid ptosis 15.55 13.90 17 425927 13310 110150045
Hyperbilirubinaemia 15.53 13.90 63 425881 30608 110132747
Blood creatinine abnormal 15.51 13.90 54 425890 5838 110157517
Hypersensitivity myocarditis 15.49 13.90 12 425932 341 110163014
Catheter site pain 15.49 13.90 3 425941 6443 110156912
Glioblastoma 15.44 13.90 28 425916 2012 110161343
Tuberculosis 15.43 13.90 28 425916 17746 110145609
Nasopharyngitis 15.42 13.90 1740 424204 392621 109770734
Pneumonia aspiration 15.41 13.90 220 425724 81013 110082342
Portal hypertension 15.36 13.90 7 425937 8630 110154725
Abdominal pain upper 15.34 13.90 1147 424797 347964 109815391
Autologous haematopoietic stem cell transplant 15.34 13.90 8 425936 111 110163244
Orthopnoea 15.29 13.90 12 425932 11009 110152346
Cardiomegaly 15.28 13.90 59 425885 29071 110134284
Facial bones fracture 15.26 13.90 48 425896 4923 110158432
Miliary pneumonia 15.19 13.90 6 425938 41 110163314
Venoocclusive disease 15.16 13.90 3 425941 6347 110157008
Scleroderma 15.13 13.90 3 425941 6338 110157017
Respiratory disorder 15.11 13.90 189 425755 71193 110092162
Respiratory distress 15.09 13.90 181 425763 68693 110094662
Acute biphenotypic leukaemia 15.00 13.90 9 425935 166 110163189
Blood viscosity increased 14.94 13.90 12 425932 360 110162995
Gangrene 14.86 13.90 25 425919 16316 110147039
Plateletcrit decreased 14.83 13.90 6 425938 44 110163311
Hepatic necrosis 14.81 13.90 10 425934 9912 110153443
Tricuspid valve incompetence 14.80 13.90 45 425899 23828 110139527
Crepitations 14.78 13.90 12 425932 10823 110152532
Self-medication 14.77 13.90 3 425941 6229 110157126
Peripheral coldness 14.76 13.90 122 425822 18418 110144937
Paraesthesia oral 14.74 13.90 73 425871 33598 110129757
Bronchopulmonary aspergillosis allergic 14.72 13.90 7 425937 8419 110154936
Infusion site swelling 14.68 13.90 10 425934 9867 110153488
Catheter site thrombosis 14.67 13.90 15 425929 619 110162736
Photosensitivity reaction 14.63 13.90 50 425894 25539 110137816
Renal cyst 14.58 13.90 30 425914 18142 110145213
Areflexia 14.57 13.90 4 425940 6765 110156590
Emergency care examination 14.51 13.90 10 425934 236 110163119
Metastatic malignant melanoma 14.46 13.90 37 425907 3372 110159983
Tendon disorder 14.45 13.90 7 425937 8330 110155025
Herpes simplex 14.44 13.90 24 425920 15740 110147615
Transplant 14.44 13.90 21 425923 1253 110162102
Cancer pain 14.44 13.90 58 425886 6714 110156641
Retroperitoneal haematoma 14.43 13.90 3 425941 6128 110157227
Expired product administered 14.40 13.90 7 425937 8313 110155042
Papule 14.35 13.90 77 425867 10056 110153299
Hyperproteinaemia 14.31 13.90 11 425933 309 110163046
Gingivitis 14.29 13.90 78 425866 10253 110153102
Disorientation 14.26 13.90 189 425755 70482 110092873
Hypocalcaemia 14.23 13.90 341 425603 65025 110098330
Lymphatic duct injury 14.17 13.90 6 425938 50 110163305
Urinary tract obstruction 14.11 13.90 48 425896 5129 110158226
Catheter site erythema 14.08 13.90 3 425941 6025 110157330
Venoocclusive liver disease 14.07 13.90 23 425921 15184 110148171
Panniculitis 14.02 13.90 24 425920 15558 110147797
Inguinal hernia 14.02 13.90 63 425881 7662 110155693
Endophthalmitis 14.00 13.90 7 425937 8180 110155175
Drooling 13.97 13.90 5 425939 7134 110156221
Papillary thyroid cancer 13.97 13.90 33 425911 2861 110160494
Embolism 13.95 13.90 109 425835 16180 110147175

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Paternal exposure timing unspecified 51.72 30.08 7 5 15 113926

Pharmacologic Action:

SourceCodeDescription
ATC L04AX04 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
MeSH PA D000970 Antineoplastic Agents
MeSH PA D006131 Growth Inhibitors
MeSH PA D006133 Growth Substances
MeSH PA D007155 Immunologic Factors
MeSH PA D020533 Angiogenesis Inhibitors
FDA EPC N0000184014 Thalidomide Analog
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:48422 angiogenesis inhibitor
CHEBI has role CHEBI:50846 immunomodulator
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:75835 anti-anaemic agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

L04AX Other immunosuppressants 8 drugs
azathioprinedimethyl fumaratediroximel fumaratemethotrexatepirfenidonepomalidomidetegomil fumaratethalidomide

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

DiseaseRelationSNOMED_IDDOID
Follicular lymphoma indication 55150002
Multiple myeloma indication 109989006 DOID:9538
Myelodysplastic syndrome indication 109995007
Mantle cell lymphoma indication 443487006
Marginal zone lymphoma indication 447100004
Deep venous thrombosis contraindication 128053003
Impaired renal function disorder contraindication 197663003
Pulmonary thromboembolism contraindication 233935004
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Thromboembolic disorder contraindication 371039008
Primary malignant neoplasm contraindication 372087000
Breastfeeding (mother) contraindication 413712001
Chemotherapy-Induced Hyperuricemia contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.17 acidic
pKa2 3.13 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
15MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
2.5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 21, 2011 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
20MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 5, 2013 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
25MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL 8741929 March 8, 2028 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
10MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
15MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
15MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
2.5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 21, 2011 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
2.5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 21, 2011 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
20MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 5, 2013 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
20MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 5, 2013 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
25MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
25MG REVLIMID BRISTOL MYERS SQUIBB N021880 June 29, 2006 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)
5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED FOLLICULAR LYMPHOMA (FL)
5MG REVLIMID BRISTOL MYERS SQUIBB N021880 Dec. 27, 2005 RX CAPSULE ORAL May 28, 2026 INDICATED IN COMBINATION WITH A RITUXIMAB PRODUCT FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED MARGINAL ZONE LYMPHOMA (MZL)

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Protein cereblon Cytosolic other MODULATOR EC50 6.53 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Tumor necrosis factor Cytokine IC50 7.89 WOMBAT-PK
Bromodomain-containing protein 4 Nuclear other IC50 5.29 CHEMBL
Interleukin-1 beta Cytokine IC50 6.41 CHEMBL
Cereblon isoform 4 Cytosolic other Ki 5.51 CHEMBL

External reference:

IDSource
4025089 VUID
N0000175347 NUI
D04687 KEGG_DRUG
4025089 VANDF
C1144149 UMLSCUI
CHEBI:63791 CHEBI
CHEMBL848 ChEMBL_ID
DB00480 DRUGBANK_ID
D000077269 MESH_DESCRIPTOR_UI
216326 PUBCHEM_CID
7331 IUPHAR_LIGAND_ID
8505 INN_ID
F0P408N6V4 UNII
337535 RXNORM
20816 MMSL
355195 MMSL
399995 MMSL
73707 MMSL
d05696 MMSL
011171 NDDF
421471009 SNOMEDCT_US
421737001 SNOMEDCT_US
F0P408N6V4 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1935 CAPSULE 2.50 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1936 CAPSULE 5 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1937 CAPSULE 10 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1940 CAPSULE 25 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1941 CAPSULE 15 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0378-1942 CAPSULE 20 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1241 CAPSULE 2.50 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1242 CAPSULE 5 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1243 CAPSULE 10 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1244 CAPSULE 15 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1245 CAPSULE 20 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 0480-1246 CAPSULE 25 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1402 CAPSULE 2.50 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1405 CAPSULE 5 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1410 CAPSULE 10 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1415 CAPSULE 15 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1420 CAPSULE 20 mg ORAL ANDA 30 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 0574-1425 CAPSULE 25 mg ORAL ANDA 30 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-692 CAPSULE 2.50 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-693 CAPSULE 5 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-694 CAPSULE 10 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-695 CAPSULE 15 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-696 CAPSULE 20 mg ORAL ANDA 32 sections
Lenalidomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-697 CAPSULE 25 mg ORAL ANDA 32 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-257 CAPSULE 2.50 mg ORAL ANDA 29 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-258 CAPSULE 5 mg ORAL ANDA 29 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-259 CAPSULE 10 mg ORAL ANDA 29 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-260 CAPSULE 15 mg ORAL ANDA 29 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-261 CAPSULE 20 mg ORAL ANDA 29 sections
LENALIDOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 31722-262 CAPSULE 25 mg ORAL ANDA 29 sections