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

Stem definitionDrug idCAS RN
human origin 4966 815610-63-0

Description:

MoleculeDescription

Synonyms:

  • ustekinumab
  • stelara
  • CNTO 1275
  • CNTO-1275
A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.54 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 25, 2020 PMDA Janssen Pharmaceutical K.K.
Sept. 25, 2009 FDA CENTOCOR ORTHO BIOTECH INC
Jan. 1, 2009 EMA

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
Product dose omission issue 1311.62 18.07 3104 323975 288583 90012785
Rheumatoid factor positive 1265.26 18.07 2242 324837 169408 90131960
Synovitis 1220.78 18.07 3259 323820 326493 89974875
Anti-cyclic citrullinated peptide antibody positive 1196.50 18.07 2637 324442 233796 90067572
Wound 1175.96 18.07 3048 324031 299932 90001436
Pericarditis 1152.06 18.07 2817 324262 267334 90034034
Hand deformity 1089.48 18.07 2922 324157 293440 90007928
Syringe issue 1054.13 18.07 433 326646 3569 90297799
Rheumatic fever 1000.56 18.07 1899 325180 151222 90150146
Glossodynia 975.79 18.07 2960 324119 318819 89982549
Toxicity to various agents 957.67 18.07 16 327063 287830 90013538
Helicobacter infection 954.50 18.07 2354 324725 224496 90076872
Duodenal ulcer perforation 922.24 18.07 2288 324791 219000 90082368
Acute kidney injury 900.26 18.07 67 327012 320320 89981048
Infusion related reaction 897.36 18.07 3418 323661 413362 89888006
Systemic lupus erythematosus 887.10 18.07 3096 323983 358800 89942568
Hepatic enzyme increased 885.04 18.07 3087 323992 357649 89943719
Pemphigus 878.29 18.07 2884 324195 323980 89977388
Type 2 diabetes mellitus 841.04 18.07 2096 324983 201148 90100220
Swollen joint count increased 833.65 18.07 1464 325615 109742 90191626
Hypotension 832.27 18.07 99 326980 325298 89976070
Drug interaction 827.26 18.07 41 327038 276412 90024956
Anaemia 798.00 18.07 153 326926 352649 89948719
Product use issue 776.06 18.07 2785 324294 327134 89974234
Discomfort 761.38 18.07 2448 324631 271887 90029481
Neutropenia 745.91 18.07 13 327066 224891 90076477
Injury 738.72 18.07 1960 325119 195389 90105979
Arthropathy 649.76 18.07 2830 324249 363412 89937956
Blood cholesterol increased 643.35 18.07 1928 325151 206084 90095284
General physical health deterioration 635.27 18.07 2751 324328 352364 89949004
Folliculitis 606.55 18.07 1867 325212 202486 90098882
Death 599.12 18.07 463 326616 456088 89845280
Treatment failure 581.05 18.07 2403 324676 301525 89999843
Constipation 580.57 18.07 148 326931 280247 90021121
Somnolence 558.93 18.07 54 327025 209030 90092338
Febrile neutropenia 548.13 18.07 4 327075 158345 90143023
Psoriatic arthropathy 542.70 18.07 1935 325144 226400 90074968
Irritable bowel syndrome 536.45 18.07 1808 325271 205640 90095728
Mobility decreased 534.16 18.07 2051 325028 248683 90052685
Blister 533.55 18.07 2074 325005 252924 90048444
Therapeutic product effect decreased 522.12 18.07 2184 324895 275387 90025981
Fibromyalgia 517.79 18.07 1780 325299 204489 90096879
Swelling 517.15 18.07 2921 324158 416137 89885231
Muscle injury 504.73 18.07 1593 325486 175061 90126307
Completed suicide 500.43 18.07 4 327075 145054 90156314
Cough 494.33 18.07 366 326713 368596 89932772
Fall 492.88 18.07 609 326470 481201 89820167
Liver injury 474.40 18.07 1524 325555 169043 90132325
Impaired healing 468.98 18.07 1879 325200 232320 90069048
Joint range of motion decreased 467.07 18.07 1307 325772 134336 90167032
Joint swelling 465.69 18.07 3259 323820 500041 89801327
Hyponatraemia 449.97 18.07 6 327073 133532 90167836
Sleep disorder due to general medical condition, insomnia type 447.99 18.07 1245 325834 127449 90173919
Lip dry 440.29 18.07 1063 326016 99892 90201476
Hypersensitivity 439.93 18.07 2977 324102 451700 89849668
C-reactive protein abnormal 439.86 18.07 1229 325850 126200 90175168
Alopecia 436.61 18.07 3169 323910 491902 89809466
Lower respiratory tract infection 433.39 18.07 1923 325156 248736 90052632
White blood cell count decreased 431.57 18.07 49 327030 167060 90134308
Facet joint syndrome 431.25 18.07 1038 326041 97351 90204017
Rheumatoid arthritis 426.44 18.07 2496 324583 360118 89941250
Drug intolerance 425.50 18.07 2918 324161 444673 89856695
Back pain 415.32 18.07 322 326757 316853 89984515
Musculoskeletal stiffness 414.91 18.07 2140 324939 294392 90006976
Platelet count decreased 401.11 18.07 23 327056 136946 90164422
Disease progression 399.27 18.07 48 327031 156567 90144801
Pancytopenia 398.42 18.07 7 327072 120256 90181112
Thrombocytopenia 395.49 18.07 130 326949 208595 90092773
Haemoglobin decreased 390.62 18.07 59 327020 161897 90139471
Dehydration 390.31 18.07 109 326970 194338 90107030
Needle issue 387.27 18.07 354 326725 13580 90287788
Abdominal discomfort 386.59 18.07 2995 324084 474333 89827035
Tremor 368.96 18.07 56 327023 153117 90148251
Ill-defined disorder 368.05 18.07 1481 325598 183410 90117958
Neuropathy peripheral 364.34 18.07 36 327043 136934 90164434
Hypokalaemia 349.97 18.07 34 327045 131082 90170286
Oxygen saturation decreased 345.26 18.07 9 327070 107474 90193894
Wound infection 343.60 18.07 1002 326077 105400 90195968
Cardiac arrest 336.27 18.07 9 327070 104926 90196442
Deep vein thrombosis postoperative 334.14 18.07 769 326310 70040 90231328
Road traffic accident 330.87 18.07 996 326083 106630 90194738
Dyspnoea 330.87 18.07 1849 325230 879106 89422262
Hypercholesterolaemia 323.76 18.07 948 326131 99944 90201424
Atrial fibrillation 319.17 18.07 50 327029 133561 90167807
Nausea 310.61 18.07 2544 324535 1107772 89193596
Sleep disorder 310.03 18.07 1476 325603 196554 90104814
Intentional overdose 308.62 18.07 6 327073 93828 90207540
Renal failure 308.51 18.07 51 327028 130956 90170412
Peripheral venous disease 305 18.07 825 326254 83096 90218272
Hip arthroplasty 299.15 18.07 771 326308 75437 90225931
Sciatica 297.42 18.07 923 326156 100459 90200909
Device defective 295.70 18.07 174 326905 3312 90298056
Adjustment disorder with depressed mood 295.42 18.07 641 326438 56112 90245256
X-ray abnormal 293.35 18.07 561 326518 44863 90256505
Pleural effusion 291.23 18.07 32 327047 111959 90189409
Autoimmune disorder 287.52 18.07 763 326316 75981 90225387
Urinary tract infection 287.02 18.07 411 326668 305221 89996147
Chills 286.14 18.07 63 327016 131918 90169450
Respiratory failure 285.85 18.07 43 327036 118375 90182993
Seizure 285.69 18.07 97 326982 152532 90148836
Sepsis 282.57 18.07 148 326931 179666 90121702
Adverse event 281.99 18.07 999 326080 116419 90184949
Lower limb fracture 279.67 18.07 806 326273 84207 90217161
Gait inability 279.38 18.07 1158 325921 145298 90156070
Contraindicated product administered 279.22 18.07 2045 325034 318094 89983274
Psoriasis 276.95 18.07 1162 325917 146592 90154776
Balance disorder 276.16 18.07 19 327060 97061 90204307
Bradycardia 273.22 18.07 6 327073 83841 90217527
Feeling abnormal 272.77 18.07 131 326948 167104 90134264
Exposure during pregnancy 272.12 18.07 1629 325450 236781 90064587
Stomatitis 271.39 18.07 1809 325270 272889 90028479
Hyperhidrosis 268.71 18.07 79 327000 136226 90165142
Injection site pain 267.04 18.07 147 326932 173552 90127816
Inflammation 265.75 18.07 1312 325767 177280 90124088
Grip strength decreased 265.24 18.07 836 326243 91740 90209628
Cardiac failure 263.75 18.07 40 327039 109456 90191912
Osteoarthritis 262.76 18.07 1397 325682 194333 90107035
Dislocation of vertebra 258.74 18.07 603 326476 55365 90246003
Knee arthroplasty 253.94 18.07 768 326311 82414 90218954
Retinitis 252.07 18.07 478 326601 37980 90263388
Pulmonary embolism 250.35 18.07 80 326999 130740 90170628
Syncope 245.37 18.07 86 326993 132577 90168791
Electrocardiogram QT prolonged 245.19 18.07 3 327076 72453 90228915
Lupus-like syndrome 243.24 18.07 542 326537 48304 90253064
Bone erosion 242.64 18.07 569 326510 52452 90248916
Depressed level of consciousness 242.04 18.07 4 327075 72780 90228588
Pulmonary fibrosis 239.81 18.07 893 326186 106610 90194758
Gastrointestinal haemorrhage 236.67 18.07 25 327054 90223 90211145
Renal impairment 233.27 18.07 48 327031 105373 90195995
Myalgia 232.62 18.07 175 326904 174950 90126418
Exostosis 231.04 18.07 559 326520 52575 90248793
Hypoxia 229.05 18.07 7 327072 72392 90228976
Loss of consciousness 228.47 18.07 110 326969 140128 90161240
Breast cancer stage III 226.86 18.07 746 326333 83701 90217667
Cardiac failure congestive 226.70 18.07 41 327038 98653 90202715
Night sweats 222.34 18.07 988 326091 127778 90173590
Gastrointestinal disorder 222.15 18.07 1637 325442 255050 90046318
Lupus vulgaris 219.91 18.07 496 326583 44563 90256805
Heart rate increased 219.69 18.07 67 327012 112835 90188533
Urticaria 219.66 18.07 1901 325178 310833 89990535
Joint dislocation 218.98 18.07 492 326587 44090 90257278
Hyperkalaemia 218.46 18.07 3 327076 64961 90236407
Coma 216.35 18.07 11 327068 72621 90228747
Product storage error 215.57 18.07 313 326766 19928 90281440
Obesity 215.30 18.07 852 326227 104655 90196713
Bursitis 214.51 18.07 993 326086 130661 90170707
Intestinal resection 211.94 18.07 132 326947 2795 90298573
Cognitive disorder 211.64 18.07 9 327070 69398 90231970
Agitation 210.44 18.07 7 327072 67091 90234277
Hypoglycaemia 209.90 18.07 10 327069 69838 90231530
Blood pressure increased 207.95 18.07 243 326836 196974 90104394
Epistaxis 207.54 18.07 30 327049 85095 90216273
Wheezing 206.38 18.07 1519 325560 236561 90064807
Suicide attempt 205.33 18.07 18 327061 75381 90225987
Hypoaesthesia 205.24 18.07 1880 325199 312330 89989038
Hallucination 202.98 18.07 8 327071 65951 90235417
Hepatic cirrhosis 200.62 18.07 592 326487 62661 90238707
Maternal exposure during pregnancy 198.86 18.07 2080 324999 357983 89943385
Off label use 198.51 18.07 5290 321789 1096962 89204406
Prescribed overdose 197.30 18.07 786 326293 96839 90204529
Dyspnoea exertional 194.85 18.07 18 327061 72270 90229098
Intentional product use issue 194.39 18.07 1395 325684 215497 90085871
Adverse drug reaction 192.91 18.07 884 326195 115817 90185551
Liver disorder 191.93 18.07 907 326172 120362 90181006
Blood pressure decreased 190.72 18.07 23 327056 74872 90226496
Multiple organ dysfunction syndrome 189.71 18.07 15 327064 68321 90233047
Blood glucose increased 188.08 18.07 55 327024 95191 90206177
Cardio-respiratory arrest 186.68 18.07 10 327069 63130 90238238
Productive cough 183.65 18.07 29 327050 77034 90224334
Live birth 181.32 18.07 663 326416 78444 90222924
Overdose 181.04 18.07 181 326898 157528 90143840
Therapy non-responder 172.09 18.07 959 326120 135745 90165623
C-reactive protein 169.79 18.07 360 326719 31007 90270361
Dry mouth 169.07 18.07 1191 325888 182868 90118500
Pulmonary oedema 168.56 18.07 15 327064 62065 90239303
Lung disorder 167.60 18.07 1019 326060 148864 90152504
Diarrhoea 165.31 18.07 2392 324687 936798 89364570
Erythema 164.81 18.07 364 326715 228882 90072486
Laryngitis 163.80 18.07 478 326601 50275 90251093
Deep vein thrombosis 163.32 18.07 63 327016 91557 90209811
Vision blurred 162.83 18.07 98 326981 110195 90191173
Sinusitis 159.83 18.07 1917 325162 341171 89960197
Injection site erythema 159.30 18.07 78 327001 98424 90202944
Blood pressure fluctuation 159.13 18.07 7 327072 52406 90248962
Rhabdomyolysis 158.46 18.07 6 327073 51250 90250118
Pustular psoriasis 158.35 18.07 259 326820 18297 90283071
Septic shock 158.30 18.07 53 327026 84107 90217261
Condition aggravated 157.60 18.07 3020 324059 592525 89708843
Heart rate decreased 156.56 18.07 9 327070 53496 90247872
Prescribed underdose 156.41 18.07 610 326469 74409 90226959
Interstitial lung disease 154.79 18.07 42 327037 76363 90225005
Oedema 149.74 18.07 1235 325844 199060 90102308
Anti-cyclic citrullinated peptide antibody 149.17 18.07 314 326765 26907 90274461
Neoplasm progression 145.65 18.07 3 327076 44483 90256885
Rash erythematous 145.35 18.07 29 327050 65075 90236293
Nasopharyngitis 143.13 18.07 2162 324917 404942 89896426
Drug tolerance decreased 142.86 18.07 341 326738 31789 90269579
Nasal congestion 142.75 18.07 61 327018 83353 90218015
Leukopenia 142.45 18.07 94 326985 100616 90200752
Hyperglycaemia 142.01 18.07 11 327068 50959 90250409
Oropharyngeal pain 140.63 18.07 125 326954 115062 90186306
Colectomy 140.11 18.07 108 326971 3259 90298109
Encephalopathy 138.43 18.07 7 327072 46437 90254931
Blood creatinine increased 137.59 18.07 99 326980 101287 90200081
Suicidal ideation 136.33 18.07 48 327031 73807 90227561
Pain in jaw 134.70 18.07 10 327069 47975 90253393
Walking aid user 133.94 18.07 354 326725 35152 90266216
Haematocrit decreased 132.48 18.07 4 327075 41828 90259540
Disturbance in attention 131.72 18.07 10 327069 47099 90254269
Blood bilirubin increased 131.34 18.07 6 327073 43464 90257904
Hypocalcaemia 130.84 18.07 5 327074 42363 90259005
Device issue 129.73 18.07 312 326767 29225 90272143
Product leakage 129.30 18.07 74 327005 1334 90300034
Mental status changes 129.26 18.07 8 327071 44671 90256697
Lethargy 129.25 18.07 34 327045 63105 90238263
Myocardial infarction 128.17 18.07 116 326963 105856 90195512
Disorientation 127.32 18.07 8 327071 44106 90257262
Osteonecrosis of jaw 126.60 18.07 3 327076 39100 90262268
Red blood cell count decreased 126.38 18.07 11 327068 46340 90255028
Bone pain 125.70 18.07 34 327045 61949 90239419
Drug reaction with eosinophilia and systemic symptoms 125.70 18.07 7 327072 42751 90258617
Cardiac disorder 125.58 18.07 26 327053 56846 90244522
Foot deformity 125.13 18.07 486 326593 59165 90242203
Serotonin syndrome 122.30 18.07 3 327076 37884 90263484
Alanine aminotransferase increased 121.30 18.07 149 326930 118189 90183179
Red blood cell sedimentation rate increased 120.77 18.07 604 326475 81991 90219377
Ileocaecal resection 119.62 18.07 52 327027 500 90300868
Unresponsive to stimuli 119.46 18.07 4 327075 38117 90263251
Injection site swelling 119.15 18.07 34 327045 59805 90241563
Infection 118.46 18.07 1900 325179 360194 89941174
Thrombosis 118.45 18.07 58 327021 73193 90228175
Angioedema 118.32 18.07 43 327036 64833 90236535
Drug ineffective 118.23 18.07 6112 320967 1378186 88923182
Full blood count abnormal 117.75 18.07 3 327076 36594 90264774
Acute respiratory failure 117.52 18.07 10 327069 42908 90258460
Cholestasis 116.70 18.07 3 327076 36296 90265072
Pneumonia aspiration 116.45 18.07 8 327071 40932 90260436
Eye pain 116.40 18.07 12 327067 44156 90257212
Macular degeneration 115.51 18.07 5 327074 37965 90263403
Swelling face 114.96 18.07 76 327003 81276 90220092
Urinary retention 114.72 18.07 5 327074 37739 90263629
Restlessness 114.66 18.07 3 327076 35717 90265651
Urinary incontinence 114.10 18.07 5 327074 37561 90263807
Femur fracture 112.89 18.07 16 327063 46066 90255302
Tinnitus 112.84 18.07 12 327067 43090 90258278
Agranulocytosis 112.13 18.07 3 327076 34999 90266369
Dysgeusia 112.06 18.07 26 327053 52534 90248834
Chronic kidney disease 110.71 18.07 23 327056 50168 90251200
Flushing 110.48 18.07 94 326985 88397 90212971
Hypothyroidism 109.91 18.07 28 327051 53099 90248269
Dysphonia 109.77 18.07 45 327034 63039 90238329
Hepatic function abnormal 108.99 18.07 18 327061 46270 90255098
Seronegative arthritis 108.96 18.07 218 326861 18016 90283352
Rash maculo-papular 108.18 18.07 11 327068 40922 90260446
Hypomagnesaemia 107.23 18.07 5 327074 35583 90265785
Ascites 107.13 18.07 21 327058 47719 90253649
Palpitations 106.76 18.07 207 326872 136521 90164847
Breast cancer stage II 106.63 18.07 325 326754 35009 90266359
Blood alkaline phosphatase increased 106.12 18.07 22 327057 48057 90253311
Lymphocyte count decreased 105.37 18.07 5 327074 35045 90266323
No adverse event 105.20 18.07 57 327022 67925 90233443
Intentional product misuse 104.92 18.07 101 326978 89503 90211865
Oral pain 103.96 18.07 3 327076 32680 90268688
Toxic epidermal necrolysis 103.41 18.07 3 327076 32525 90268843
Vertigo 103.07 18.07 62 327017 69749 90231619
Chronic obstructive pulmonary disease 102.94 18.07 70 327009 73759 90227609
Contusion 102.12 18.07 1369 325710 249847 90051521
Ileal stenosis 102.06 18.07 79 327000 2399 90298969
Haematoma 101.90 18.07 11 327068 39037 90262331
Neurologic neglect syndrome 101.86 18.07 142 326937 8705 90292663
Dyskinesia 101.46 18.07 8 327071 36526 90264842
Pulmonary hypertension 101.32 18.07 16 327063 42507 90258861
Blood potassium decreased 100.98 18.07 24 327055 47703 90253665
Arrhythmia 100.70 18.07 16 327063 42316 90259052
Blepharospasm 100.65 18.07 432 326647 55013 90246355
Hepatic failure 99.20 18.07 13 327066 39715 90261653
Orthostatic hypotension 99.07 18.07 16 327063 41811 90259557
Respiratory distress 99.05 18.07 12 327067 38934 90262434
Migraine 98.93 18.07 1087 325992 189305 90112063
Aspartate aminotransferase increased 98.92 18.07 136 326943 102801 90198567
Carotid artery thrombosis 98.86 18.07 142 326937 8950 90292418
Dry eye 98.11 18.07 43 327036 57888 90243480
Dry skin 96.62 18.07 105 326974 87968 90213400
Anal abscess 96.56 18.07 111 326968 5597 90295771
Haemoptysis 96.29 18.07 6 327073 33314 90268054
Pneumonitis 95.87 18.07 21 327058 44149 90257219
Ileostomy 95.43 18.07 69 327010 1885 90299483
Dyspepsia 95.14 18.07 1114 325965 197046 90104322
Coronary artery disease 94.40 18.07 7 327072 33616 90267752
Hypervolaemia 94.36 18.07 6 327073 32751 90268617
Joint stiffness 93.24 18.07 540 326539 77502 90223866
Stevens-Johnson syndrome 92.34 18.07 3 327076 29373 90271995
Intestinal anastomosis 91.54 18.07 51 327028 871 90300497
Rash 91.41 18.07 3624 323455 792476 89508892
Dysuria 91.27 18.07 16 327063 39385 90261983
Acute myocardial infarction 90.61 18.07 10 327069 34880 90266488
Shock 90.24 18.07 3 327076 28775 90272593
Device dislocation 89.99 18.07 6 327073 31476 90269892
Adjustment disorder 89.71 18.07 140 326939 9502 90291866
Subcutaneous drug absorption impaired 89.54 18.07 169 326910 13376 90287992
Tooth disorder 88.65 18.07 6 327073 31084 90270284
Blood calcium decreased 88.54 18.07 5 327074 30177 90271191
Melaena 87.82 18.07 11 327068 34786 90266582
Nail disorder 87.09 18.07 433 326646 58634 90242734
Haematemesis 86.75 18.07 10 327069 33716 90267652
COVID-19 86.64 18.07 315 326764 168528 90132840
Liver function test increased 85.55 18.07 562 326517 84293 90217075
Onychomadesis 85.51 18.07 361 326718 45637 90255731
Plasma cell myeloma 85.46 18.07 21 327058 40807 90260561
Jaundice 85.26 18.07 9 327070 32508 90268860
Pericardial effusion 85.23 18.07 15 327064 36818 90264550
Herpes zoster 85.09 18.07 131 326948 94513 90206855
Injection site pruritus 84.98 18.07 44 327035 53790 90247578
Hepatotoxicity 84.25 18.07 30 327049 45812 90255556
Device deployment issue 83.95 18.07 96 326983 4813 90296555
Generalised tonic-clonic seizure 83.46 18.07 13 327066 34890 90266478
Pallor 83.36 18.07 12 327067 34153 90267215
Sinus tachycardia 82.80 18.07 5 327074 28508 90272860
Gastritis 82.62 18.07 24 327055 41729 90259639
Delirium 82.55 18.07 652 326427 103707 90197661
Hypophagia 82.36 18.07 15 327064 35922 90265446
Illness 82.12 18.07 105 326974 81864 90219504
Ejection fraction decreased 81.40 18.07 3 327076 26250 90275118
Drug withdrawal syndrome 80.58 18.07 6 327073 28717 90272651
Lip swelling 80.54 18.07 20 327059 38590 90262778
Tachycardia 80.35 18.07 295 326784 157378 90143990
Speech disorder 80.15 18.07 32 327047 45553 90255815
C-reactive protein increased 79.77 18.07 1003 326076 180386 90120982
Asthenia 79.63 18.07 1401 325678 532350 89769018
Liquid product physical issue 78.60 18.07 56 327023 1494 90299874
Faecal calprotectin increased 78.60 18.07 84 326995 3903 90297465
Nervousness 78.51 18.07 14 327065 34042 90267326
Eye irritation 78.26 18.07 14 327065 33964 90267404
Drug level increased 77.32 18.07 6 327073 27756 90273612
Small intestinal resection 77.02 18.07 41 327038 637 90300731
Limb discomfort 76.94 18.07 21 327058 38039 90263329
Hypertension 76.71 18.07 2178 324901 455354 89846014
Ulcer haemorrhage 76.54 18.07 239 326840 26082 90275286
Aggression 76.47 18.07 5 327074 26663 90274705
Musculoskeletal pain 76.19 18.07 949 326130 170302 90131066
Ventricular tachycardia 76.01 18.07 3 327076 24705 90276663
Confusional state 75.82 18.07 1877 325202 384328 89917040
Cerebral haemorrhage 75.77 18.07 16 327063 34506 90266862
Metastases to liver 75.46 18.07 8 327071 28799 90272569
Weight decreased 75.41 18.07 943 326136 378967 89922401
Eczema 75.23 18.07 49 327030 52821 90248547
Hepatic cytolysis 75.11 18.07 11 327068 30905 90270463
Burning sensation 74.89 18.07 71 327008 63381 90237987
Hypoacusis 74.87 18.07 7 327072 27843 90273525
Weight increased 74.14 18.07 2004 325075 415923 89885445
Diabetes mellitus 73.79 18.07 75 327004 64800 90236568
Injection site bruising 73.72 18.07 49 327030 52258 90249110
Hepatocellular injury 73.46 18.07 9 327070 28949 90272419
Transient ischaemic attack 73.19 18.07 32 327047 43144 90258224
Ear infection 72.70 18.07 466 326613 69309 90232059
Haemorrhage 72.50 18.07 86 326993 69283 90232085
Therapeutic response decreased 72.29 18.07 563 326516 89166 90212202
Disability 72.06 18.07 315 326764 40430 90260938
Eosinophilia 72.05 18.07 9 327070 28524 90272844
Pulmonary arterial hypertension 71.98 18.07 6 327073 26181 90275187
Blood sodium decreased 71.49 18.07 8 327071 27605 90273763
Spondylitis 71.33 18.07 158 326921 14020 90287348
Frequent bowel movements 71.32 18.07 399 326680 56536 90244832
Depressed mood 70.84 18.07 47 327032 50175 90251193
Dysphagia 70.62 18.07 191 326888 112087 90189281
Enthesopathy 70.62 18.07 124 326955 9280 90292088
Premature delivery 70.16 18.07 26 327053 38736 90262632
Procedural pain 70.13 18.07 17 327062 33343 90268025
Metastases to bone 69.68 18.07 6 327073 25499 90275869
Food allergy 69.59 18.07 6 327073 25472 90275896
Abnormal behaviour 68.76 18.07 3 327076 22625 90278743
Atelectasis 68.76 18.07 5 327074 24404 90276964
Feeling cold 68.54 18.07 9 327070 27456 90273912
Amnesia 68.06 18.07 644 326435 107861 90193507
Diplopia 67.97 18.07 11 327068 28703 90272665
Coagulopathy 67.88 18.07 4 327075 23285 90278083
Product label confusion 67.85 18.07 209 326870 22641 90278727
Drug-induced liver injury 67.48 18.07 557 326522 89761 90211607
Immunodeficiency 67.26 18.07 36 327043 43198 90258170
Pollakiuria 67.12 18.07 18 327061 32987 90268381
Throat irritation 66.78 18.07 47 327032 48648 90252720
Dizziness 66.78 18.07 1618 325461 587666 89713702
Anal fistula 66.71 18.07 80 326999 4221 90297147
Ileectomy 66.61 18.07 29 327050 280 90301088
Porphyria acute 66.56 18.07 178 326901 17797 90283571
Eye disorder 65.95 18.07 10 327069 27380 90273988
Stress 65.48 18.07 121 326958 81274 90220094
Visual acuity reduced 65.36 18.07 5 327074 23405 90277963
Personality disorder 65.24 18.07 141 326938 12303 90289065
Paraesthesia oral 64.88 18.07 17 327062 31642 90269726
Swollen tongue 64.83 18.07 43 327036 45913 90255455
Anaphylactic shock 64.75 18.07 17 327062 31600 90269768
Tachypnoea 64.18 18.07 3 327076 21306 90280062
Rash vesicular 64.18 18.07 177 326902 18020 90283348
Mouth ulceration 64.10 18.07 32 327047 39942 90261426
Hot flush 64.06 18.07 72 327007 59416 90241952
Unevaluable event 64.00 18.07 62 327017 54786 90246582
Chronic sinusitis 63.94 18.07 6 327073 23796 90277572
Upper gastrointestinal haemorrhage 63.89 18.07 5 327074 22971 90278397
Oral candidiasis 63.81 18.07 24 327055 35431 90265937
Vaginal haemorrhage 63.69 18.07 17 327062 31254 90270114
Blood pressure systolic increased 63.51 18.07 70 327009 58275 90243093
Head injury 63.44 18.07 17 327062 31171 90270197
Skin discolouration 63.15 18.07 41 327038 44274 90257094
Blood creatine phosphokinase increased 62.98 18.07 22 327057 34001 90267367
Rib fracture 62.86 18.07 10 327069 26425 90274943
Leukocytosis 62.83 18.07 17 327062 30973 90270395
Chest discomfort 62.80 18.07 271 326808 138094 90163274
Restless legs syndrome 62.17 18.07 5 327074 22465 90278903
Skin haemorrhage 62.04 18.07 194 326885 21186 90280182
Hip fracture 61.90 18.07 21 327058 33056 90268312
Disseminated intravascular coagulation 61.87 18.07 4 327075 21534 90279834
Hiatus hernia 61.66 18.07 9 327070 25352 90276016
Acute respiratory distress syndrome 61.53 18.07 14 327065 28672 90272696
Body temperature increased 61.52 18.07 43 327036 44667 90256701
General symptom 61.28 18.07 152 326927 14516 90286852
Back injury 61.26 18.07 331 326748 46291 90255077
Renal disorder 61.17 18.07 30 327049 37829 90263539
Vomiting 60.94 18.07 2279 324800 786014 89515354
Lymphopenia 60.86 18.07 6 327073 22875 90278493
Blood glucose decreased 60.12 18.07 7 327072 23422 90277946
Blood pressure diastolic decreased 59.77 18.07 12 327067 26814 90274554
Wrong technique in product usage process 59.73 18.07 104 326975 71467 90229901
Mitral valve incompetence 59.66 18.07 6 327073 22518 90278850
Glaucoma 59.19 18.07 4 327075 20751 90280617
Blood potassium increased 59.17 18.07 4 327075 20745 90280623
Ocular hyperaemia 58.97 18.07 24 327055 33774 90267594
Drug level decreased 58.94 18.07 117 326962 9613 90291755
Inappropriate schedule of product administration 58.80 18.07 812 326267 149121 90152247
Infusion site pain 58.74 18.07 3 327076 19735 90281633
Accidental overdose 58.29 18.07 15 327064 28258 90273110
Rectal abscess 57.84 18.07 46 327033 1454 90299914
Transaminases increased 57.81 18.07 31 327048 37161 90264207
Cyanosis 57.76 18.07 3 327076 19452 90281916
Withdrawal syndrome 57.13 18.07 7 327072 22517 90278851
Underdose 57.04 18.07 362 326717 53655 90247713
Movement disorder 56.83 18.07 17 327062 29002 90272366
Drug delivery system malfunction 56.82 18.07 44 327035 1337 90300031
Body temperature decreased 56.65 18.07 9 327070 23807 90277561
Electrolyte imbalance 56.42 18.07 9 327070 23736 90277632
Intestinal stenosis 55.94 18.07 64 327015 3210 90298158
Tubulointerstitial nephritis 55.10 18.07 12 327067 25331 90276037
Cerebral infarction 55.04 18.07 14 327065 26582 90274786
Eye injury 54.53 18.07 122 326957 10898 90290470
Nightmare 54.50 18.07 7 327072 21718 90279650
Radiculopathy 54.48 18.07 3 327076 18502 90282866
Gangrene 54.39 18.07 134 326945 12742 90288626
Premature baby 54.27 18.07 12 327067 25065 90276303
Drug resistance 54.15 18.07 21 327058 30428 90270940
Bronchiectasis 54.12 18.07 8 327071 22322 90279046
Bacteraemia 54.02 18.07 8 327071 22292 90279076
Red blood cell sedimentation rate 53.98 18.07 75 327004 4583 90296785
Osteonecrosis 53.95 18.07 14 327065 26227 90275141
Neuralgia 53.94 18.07 23 327056 31477 90269891
Toothache 53.79 18.07 8 327071 22222 90279146
Myoclonus 53.78 18.07 4 327075 19164 90282204
Onychomycosis 53.68 18.07 272 326807 37104 90264264
Finger deformity 53.43 18.07 248 326831 32649 90268719
Dermatitis atopic 53.35 18.07 10 327069 23462 90277906
Enteral nutrition 53.20 18.07 23 327056 218 90301150
Foot fracture 53.18 18.07 15 327064 26591 90274777
Spinal fracture 53.10 18.07 8 327071 22008 90279360
Peripheral swelling 53.08 18.07 1905 325174 411201 89890167
Arterial occlusive disease 53.08 18.07 130 326949 12316 90289052
Product dose omission in error 52.93 18.07 6 327073 20497 90280871
Ileal ulcer 52.88 18.07 38 327041 1028 90300340
Pancreatitis acute 52.57 18.07 25 327054 32090 90269278
Dementia 52.49 18.07 11 327068 23850 90277518
Osteoporosis 52.36 18.07 556 326523 95975 90205393
Musculoskeletal discomfort 52.09 18.07 7 327072 20984 90280384
Rash macular 52.03 18.07 22 327057 30258 90271110
Seasonal allergy 51.80 18.07 10 327069 22973 90278395
Bronchospasm 51.17 18.07 7 327072 20702 90280666
Fracture 51.05 18.07 9 327070 22067 90279301
Retching 51.02 18.07 5 327074 19154 90282214
Transfusion 50.98 18.07 3 327076 17485 90283883
Sinus congestion 50.79 18.07 215 326864 27209 90274159
Proteinuria 50.70 18.07 11 327068 23280 90278088
Sensory loss 50.61 18.07 162 326917 17913 90283455
Nodule 49.84 18.07 17 327062 26669 90274699
Pregnancy 49.80 18.07 389 326690 61658 90239710
Arthritis 49.48 18.07 864 326215 166451 90134917
Haematuria 48.87 18.07 33 327046 34904 90266464
Presyncope 48.72 18.07 27 327052 31778 90269590
Gastric ulcer 48.70 18.07 19 327060 27429 90273939
Chromaturia 48.58 18.07 6 327073 19181 90282187
Sleep apnoea syndrome 48.56 18.07 27 327052 31720 90269648
Crying 48.48 18.07 16 327063 25629 90275739
Dysstasia 48.48 18.07 15 327064 25037 90276331
Subdural haematoma 48.09 18.07 3 327076 16642 90284726
Cytopenia 47.95 18.07 4 327075 17445 90283923
Heart rate irregular 47.92 18.07 14 327065 24254 90277114
Cardiac murmur 47.79 18.07 5 327074 18189 90283179
Swollen joint count 47.62 18.07 100 326979 8553 90292815
Bone density decreased 47.60 18.07 4 327075 17341 90284027
Pneumocystis jirovecii pneumonia 47.48 18.07 10 327069 21606 90279762
Poor quality sleep 47.40 18.07 15 327064 24678 90276690
Intervertebral disc degeneration 47.36 18.07 4 327075 17270 90284098
Product administration error 47.36 18.07 18 327061 26405 90274963
Myelodysplastic syndrome 47.31 18.07 9 327070 20894 90280474
Oesophagitis 47.28 18.07 4 327075 17245 90284123
Flatulence 46.84 18.07 48 327031 41319 90260049
Stoma site oedema 46.68 18.07 17 327062 97 90301271
Clostridium difficile colitis 46.54 18.07 19 327060 26687 90274681
Flank pain 46.32 18.07 7 327072 19215 90282153
Abdominal pain upper 46.19 18.07 1548 325531 331126 89970242
Rhinitis allergic 45.71 18.07 4 327075 16781 90284587
Sputum discoloured 45.69 18.07 9 327070 20382 90280986
Taste disorder 45.66 18.07 379 326700 61167 90240201
Hemiplegia 45.39 18.07 145 326934 16015 90285353
Ear injury 45.38 18.07 23 327056 321 90301047
Neutropenic sepsis 45.10 18.07 6 327073 18124 90283244
Fistula 45.05 18.07 120 326959 11969 90289399
Eye swelling 44.94 18.07 25 327054 29361 90272007
Cutaneous T-cell lymphoma 44.71 18.07 41 327038 1579 90299789
Progressive multifocal leukoencephalopathy 44.70 18.07 3 327076 15652 90285716
Cytomegalovirus infection 44.64 18.07 20 327059 26582 90274786
Mood swings 44.61 18.07 10 327069 20692 90280676
Musculoskeletal chest pain 44.58 18.07 15 327064 23735 90277633
Lacrimation increased 44.40 18.07 21 327058 27041 90274327
Pyrexia 44.22 18.07 1941 325138 658544 89642824
Generalised oedema 43.56 18.07 8 327071 19045 90282323
Joint effusion 43.53 18.07 9 327070 19701 90281667
Blood test abnormal 43.42 18.07 11 327068 20941 90280427
Blood pressure abnormal 43.33 18.07 9 327070 19636 90281732
Face oedema 43.29 18.07 15 327064 23303 90278065
Cardiomegaly 43.15 18.07 8 327071 18917 90282451
Gamma-glutamyltransferase increased 43.02 18.07 44 327035 37908 90263460
Blindness 43.00 18.07 21 327058 26547 90274821
Status epilepticus 42.99 18.07 8 327071 18866 90282502
Eye pruritus 42.54 18.07 26 327053 29001 90272367
Limb injury 42.43 18.07 31 327048 31477 90269891
Panic attack 42.43 18.07 21 327058 26344 90275024
Petechiae 42.20 18.07 4 327075 15737 90285631
Gingival bleeding 42.13 18.07 3 327076 14900 90286468
Conjunctivitis 41.89 18.07 22 327057 26684 90274684
Skin laceration 41.50 18.07 21 327058 26014 90275354
Maternal exposure timing unspecified 41.43 18.07 176 326903 22307 90279061
Cholelithiasis 41.40 18.07 79 327000 52427 90248941
Muscle twitching 40.92 18.07 18 327061 24184 90277184
Vaginal discharge 40.76 18.07 10 327069 19454 90281914
Accidental exposure to product 40.53 18.07 277 326802 42089 90259279
Liver function test abnormal 40.53 18.07 76 327003 50769 90250599
Adverse reaction 40.43 18.07 213 326866 29499 90271869
Memory impairment 40.25 18.07 964 326115 196280 90105088
Injection site urticaria 40.25 18.07 8 327071 18003 90283365
Multiple allergies 40.21 18.07 4 327075 15142 90286226
Fear 40.18 18.07 6 327073 16616 90284752
Blood urine present 40.05 18.07 7 327072 17271 90284097
Spinal osteoarthritis 39.78 18.07 10 327069 19138 90282230
Rash papular 39.73 18.07 12 327067 20343 90281025
Injection site mass 39.67 18.07 15 327064 22075 90279293
Thyroid disorder 39.53 18.07 8 327071 17777 90283591
Tenderness 39.46 18.07 24 327055 26844 90274524
Schizophrenia 39.43 18.07 4 327075 14910 90286458
Chronic recurrent multifocal osteomyelitis 39.43 18.07 13 327066 52 90301316
Bone disorder 39.40 18.07 17 327062 23103 90278265
Purpura 38.98 18.07 4 327075 14774 90286594
Emotional distress 38.79 18.07 45 327034 36617 90264751
Pulmonary congestion 38.76 18.07 11 327068 19422 90281946
Device difficult to use 38.71 18.07 8 327071 17517 90283851
Peripheral coldness 38.69 18.07 3 327076 13889 90287479
Anastomotic stenosis 38.27 18.07 22 327057 400 90300968
Anaphylactic reaction 38.15 18.07 174 326905 87350 90214018
Psychotic disorder 37.97 18.07 34 327045 31196 90270172
Pelvic fracture 37.95 18.07 5 327074 15214 90286154
Platelet count increased 37.74 18.07 14 327065 20845 90280523
Intervertebral disc protrusion 37.62 18.07 26 327053 27170 90274198
Mood altered 37.51 18.07 8 327071 17136 90284232
Osteopenia 37.51 18.07 18 327061 22984 90278384
Therapy interrupted 37.27 18.07 78 327001 50030 90251338
Emotional disorder 37.22 18.07 5 327074 14992 90286376
Urosepsis 37.17 18.07 15 327064 21217 90280151
Affect lability 36.92 18.07 146 326933 17917 90283451
Product packaging issue 36.71 18.07 37 327042 1604 90299764
Tongue disorder 36.69 18.07 104 326975 10756 90290612
Injection site warmth 36.67 18.07 9 327070 17506 90283862
Feeding disorder 36.66 18.07 9 327070 17503 90283865
Blood albumin decreased 36.44 18.07 8 327071 16795 90284573
Injection site rash 36.34 18.07 21 327058 24152 90277216
Hyperbilirubinaemia 36.17 18.07 4 327075 13932 90287436
Subarachnoid haemorrhage 35.96 18.07 10 327069 17894 90283474
Metastases to lung 35.95 18.07 7 327072 15984 90285384
Myocarditis 35.74 18.07 4 327075 13802 90287566
Myositis 35.64 18.07 177 326902 23951 90277417
Anger 35.46 18.07 4 327075 13716 90287652
Epilepsy 35.44 18.07 453 326626 81753 90219615
Impaired gastric emptying 35.03 18.07 3 327076 12806 90288562
Red blood cell sedimentation rate abnormal 35.02 18.07 22 327057 24182 90277186
Upper limb fracture 35.01 18.07 17 327062 21561 90279807
Muscle rigidity 34.97 18.07 5 327074 14304 90287064
Polyneuropathy 34.96 18.07 13 327066 19328 90282040
Candida infection 34.76 18.07 43 327036 34014 90267354
Deafness 34.65 18.07 19 327060 22495 90278873
Foetal exposure during pregnancy 34.46 18.07 64 327015 42911 90258457
Pneumothorax 34.45 18.07 13 327066 19154 90282214
Stenosis 34.37 18.07 40 327039 2044 90299324
Mania 34.37 18.07 5 327074 14119 90287249
Haemophagocytic lymphohistiocytosis 34.27 18.07 7 327072 15452 90285916
Posterior reversible encephalopathy syndrome 34.17 18.07 19 327060 22320 90279048
Product administration interrupted 33.96 18.07 3 327076 12489 90288879
Viral infection 33.81 18.07 61 327018 41353 90260015
Hypertensive crisis 33.79 18.07 11 327068 17773 90283595
Hypoalbuminaemia 33.62 18.07 8 327071 15889 90285479
Myocardial ischaemia 33.36 18.07 5 327074 13809 90287559
Upper-airway cough syndrome 33.24 18.07 7 327072 15128 90286240
Hepatic encephalopathy 33.22 18.07 5 327074 13767 90287601
Infusion site erythema 32.89 18.07 5 327074 13665 90287703
Mental disorder 32.78 18.07 41 327038 32277 90269091
Foetal death 32.61 18.07 17 327062 20706 90280662
Brain oedema 32.59 18.07 11 327068 17374 90283994
Psychomotor hyperactivity 32.46 18.07 4 327075 12809 90288559
Dermatitis allergic 32.42 18.07 11 327068 17316 90284052
Myopathy 32.40 18.07 5 327074 13513 90287855
Hypophosphataemia 32.36 18.07 7 327072 14847 90286521
Cardiac failure acute 32.06 18.07 3 327076 11926 90289442
Apoptotic colonopathy 32.03 18.07 12 327067 75 90301293
Motor dysfunction 31.99 18.07 146 326933 19084 90282284
Device breakage 31.89 18.07 6 327073 14038 90287330
Colostomy 31.89 18.07 31 327048 1286 90300082
Abscess intestinal 31.79 18.07 37 327042 1891 90299477
Left ventricular dysfunction 31.78 18.07 7 327072 14662 90286706
Rotator cuff syndrome 31.77 18.07 9 327070 15910 90285458
Oral herpes 31.49 18.07 45 327034 33479 90267889
Muscle spasticity 31.47 18.07 227 326852 35095 90266273
Diabetes mellitus inadequate control 31.43 18.07 14 327065 18670 90282698
Grip strength 31.42 18.07 87 326992 8878 90292490
Faeces discoloured 31.38 18.07 19 327060 21301 90280067
Adrenal insufficiency 31.36 18.07 37 327042 29884 90271484
Toxic skin eruption 31.33 18.07 9 327070 15765 90285603
Pyoderma gangrenosum 31.14 18.07 57 327022 4407 90296961
Central nervous system lesion 31.11 18.07 3 327076 11643 90289725
Inflammatory bowel disease 31.10 18.07 62 327017 5109 90296259
Ecchymosis 30.84 18.07 4 327075 12319 90289049
Hypoaesthesia oral 30.80 18.07 9 327070 15591 90285777
Poor venous access 30.76 18.07 16 327063 19511 90281857
Eyelid oedema 30.74 18.07 3 327076 11531 90289837
Injection related reaction 30.69 18.07 28 327051 1071 90300297
Mental impairment 30.62 18.07 11 327068 16709 90284659
Basal cell carcinoma 30.58 18.07 216 326863 33173 90268195
Ageusia 30.44 18.07 10 327069 16066 90285302
Bacterial infection 30.38 18.07 24 327055 23420 90277948
Temperature intolerance 29.88 18.07 4 327075 12026 90289342
Gastrointestinal bacterial overgrowth 29.69 18.07 24 327055 777 90300591
Enteropathic spondylitis 29.57 18.07 10 327069 44 90301324
Urine output decreased 29.45 18.07 5 327074 12598 90288770
Tooth fracture 29.44 18.07 5 327074 12595 90288773
Nervous system disorder 29.40 18.07 21 327058 21572 90279796
Ventricular extrasystoles 29.37 18.07 6 327073 13244 90288124
Drug ineffective for unapproved indication 29.34 18.07 132 326947 66512 90234856
Lichen myxoedematosus 29.27 18.07 9 327070 27 90301341
Heavy menstrual bleeding 29.24 18.07 19 327060 20511 90280857
Hypersomnia 29.23 18.07 21 327058 21510 90279858
Spinal fusion surgery 29.02 18.07 104 326975 12179 90289189
Lymphoedema 28.93 18.07 7 327072 13746 90287622
Thinking abnormal 28.91 18.07 4 327075 11728 90289640
Infusion site swelling 28.87 18.07 4 327075 11716 90289652
Haemolytic anaemia 28.79 18.07 4 327075 11693 90289675
Acute generalised exanthematous pustulosis 28.77 18.07 7 327072 13696 90287672
Erythrodermic psoriasis 28.61 18.07 27 327052 1079 90300289
Pseudomonas infection 28.58 18.07 9 327070 14856 90286512
Staphylococcal infection 28.54 18.07 85 326994 48354 90253014
COVID-19 pneumonia 28.47 18.07 15 327064 18162 90283206
Tenosynovitis 28.38 18.07 116 326963 14451 90286917
Cardiomyopathy 28.37 18.07 19 327060 20187 90281181
Aspergillus infection 28.36 18.07 3 327076 10820 90290548
Sacroiliitis 28.33 18.07 53 327026 4166 90297202
Pelvic pain 28.30 18.07 10 327069 15347 90286021
Vitamin D deficiency 28.23 18.07 14 327065 17542 90283826
Concomitant disease aggravated 28.21 18.07 4 327075 11514 90289854
Cardiovascular disorder 28.12 18.07 7 327072 13485 90287883
Faecal calprotectin abnormal 28.04 18.07 14 327065 189 90301179
Stoma closure 27.97 18.07 14 327065 190 90301178
Hypogammaglobulinaemia 27.87 18.07 3 327076 10671 90290697
Parathyroid disorder 27.85 18.07 23 327056 768 90300600
Back disorder 27.82 18.07 173 326906 25458 90275910
Spinal compression fracture 27.77 18.07 10 327069 15168 90286200
Breast cancer metastatic 27.64 18.07 10 327069 15122 90286246
Terminal ileitis 27.63 18.07 28 327051 1222 90300146
Blood magnesium decreased 27.61 18.07 11 327068 15682 90285686
Dialysis 27.59 18.07 4 327075 11325 90290043
Neutrophil count increased 27.54 18.07 18 327061 19372 90281996
Latent tuberculosis 27.39 18.07 43 327036 2933 90298435
Abnormal dreams 27.36 18.07 4 327075 11253 90290115
Cervix carcinoma stage 0 27.27 18.07 20 327059 559 90300809
Vasculitis 27.24 18.07 25 327054 22668 90278700
Pleuritic pain 27.16 18.07 3 327076 10458 90290910
Large intestinal stenosis 27.15 18.07 39 327040 2458 90298910
Fluid retention 27.14 18.07 196 326883 87895 90213473
Complication of device insertion 27.08 18.07 3 327076 10433 90290935
Arthralgia 26.96 18.07 3206 323873 775316 89526052
Squamous cell carcinoma 26.90 18.07 89 326990 10012 90291356
Disease recurrence 26.85 18.07 60 327019 37593 90263775
Sensory disturbance 26.80 18.07 11 327068 15402 90285966
Feeling jittery 26.68 18.07 11 327068 15360 90286008
Apathy 26.65 18.07 4 327075 11036 90290332
Product substitution issue 26.57 18.07 16 327063 17992 90283376
Omentoplasty 26.53 18.07 8 327071 22 90301346
Bronchitis 26.53 18.07 390 326689 152537 90148831
Renal cyst 26.45 18.07 7 327072 12943 90288425
Lung infiltration 26.42 18.07 11 327068 15271 90286097
Complication associated with device 26.37 18.07 19 327060 19430 90281938
Supraventricular tachycardia 26.31 18.07 13 327066 16323 90285045
Head discomfort 26.30 18.07 13 327066 16320 90285048
Loss of therapeutic response 26.21 18.07 32 327047 1720 90299648
Eructation 26.14 18.07 4 327075 10878 90290490
Cholangitis sclerosing 26.09 18.07 36 327043 2185 90299183
Stoma creation 26.04 18.07 12 327067 134 90301234
Acute coronary syndrome 25.92 18.07 4 327075 10809 90290559
Diverticulum 25.80 18.07 6 327073 12107 90289261
Skin plaque 25.77 18.07 87 326992 9888 90291480
Polyuria 25.76 18.07 3 327076 10037 90291331
Exposure via skin contact 25.57 18.07 4 327075 10701 90290667
Vitamin D decreased 25.39 18.07 6 327073 11973 90289395
Pharyngeal oedema 25.32 18.07 9 327070 13762 90287606
Blood triglycerides increased 25.29 18.07 9 327070 13752 90287616
Blood parathyroid hormone decreased 25.18 18.07 99 326980 12117 90289251
Localised infection 25.16 18.07 52 327027 33510 90267858
Ankle fracture 24.98 18.07 22 327057 20348 90281020
Decubitus ulcer 24.87 18.07 6 327073 11807 90289561
Dermatitis contact 24.80 18.07 9 327070 13586 90287782
Injection site induration 24.80 18.07 4 327075 10464 90290904
Impaired work ability 24.77 18.07 20 327059 19306 90282062
Synovial cyst 24.68 18.07 6 327073 11746 90289622
Cold sweat 24.56 18.07 10 327069 14071 90287297
Peritonitis 24.50 18.07 21 327058 19684 90281684
Metastases to lymph nodes 24.49 18.07 6 327073 11683 90289685
Infusion site extravasation 24.35 18.07 4 327075 10324 90291044
Dermatitis bullous 24.31 18.07 4 327075 10312 90291056
Klebsiella infection 24.25 18.07 4 327075 10293 90291075
Pneumonia bacterial 24.14 18.07 8 327071 12782 90288586
Therapeutic product effect incomplete 24.08 18.07 891 326188 193005 90108363
Blood glucose abnormal 23.95 18.07 3 327076 9489 90291879
Paralysis 23.83 18.07 6 327073 11472 90289896
Proctocolectomy 23.77 18.07 10 327069 88 90301280
Anal stenosis 23.73 18.07 18 327061 530 90300838
Ischaemic stroke 23.68 18.07 27 327052 22139 90279229
Multiple sclerosis 23.64 18.07 40 327039 27800 90273568
Increased tendency to bruise 23.22 18.07 7 327072 11883 90289485
Nephropathy 23.11 18.07 3 327076 9232 90292136
Tendonitis 23.04 18.07 144 326935 21228 90280140
Therapeutic response unexpected 22.99 18.07 27 327052 21853 90279515
Wrist fracture 22.89 18.07 14 327065 15610 90285758
Increased appetite 22.84 18.07 7 327072 11758 90289610
Gastroenteritis viral 22.78 18.07 47 327032 30308 90271060
Dermatitis 22.73 18.07 28 327051 22192 90279176
Gastrointestinal wall thickening 22.69 18.07 33 327046 2104 90299264
Pulmonary thrombosis 22.59 18.07 4 327075 9778 90291590
Overlap syndrome 22.48 18.07 75 327004 8473 90292895
Granuloma skin 22.38 18.07 87 326992 10593 90290775
Eyelid ptosis 22.36 18.07 3 327076 9003 90292365
Foot operation 22.34 18.07 3 327076 8998 90292370
Hyperthermia 22.25 18.07 5 327074 10330 90291038
Acute myeloid leukaemia 22.20 18.07 25 327054 20615 90280753
Hyperthyroidism 22.18 18.07 20 327059 18290 90283078
Gingival pain 22.18 18.07 4 327075 9648 90291720
Gout 22.17 18.07 17 327062 16842 90284526
Pulseless electrical activity 22.11 18.07 3 327076 8929 90292439
Haemorrhoids 22.09 18.07 39 327040 26663 90274705
Sensitivity to weather change 22.06 18.07 3 327076 8911 90292457
Thirst 21.98 18.07 16 327063 16279 90285089
Blood calcium increased 21.97 18.07 8 327071 12050 90289318
Femoral neck fracture 21.93 18.07 5 327074 10228 90291140
Multiple fractures 21.89 18.07 4 327075 9558 90291810
Coordination abnormal 21.85 18.07 142 326937 21214 90280154
Ear discomfort 21.83 18.07 5 327074 10195 90291173
Gastrointestinal toxicity 21.59 18.07 4 327075 9463 90291905
Ligament sprain 21.50 18.07 13 327066 14586 90286782
Glycosylated haemoglobin increased 21.36 18.07 15 327064 15547 90285821
Major depression 21.32 18.07 5 327074 10030 90291338
Blood iron decreased 21.30 18.07 20 327059 17939 90283429
Splenomegaly 21.25 18.07 10 327069 12914 90288454
Lymphadenopathy 21.16 18.07 89 326990 45686 90255682
Intestinal anastomosis complication 21.09 18.07 14 327065 332 90301036
Iron deficiency anaemia 21.02 18.07 33 327046 23629 90277739
Amenorrhoea 20.98 18.07 8 327071 11714 90289654
End stage renal disease 20.93 18.07 3 327076 8568 90292800
Photosensitivity reaction 20.92 18.07 20 327059 17787 90283581
Scar 20.92 18.07 15 327064 15380 90285988
Colitis 20.88 18.07 157 326922 69785 90231583
Abdominal pain lower 20.78 18.07 49 327030 30128 90271240
Cerebrovascular accident 20.75 18.07 317 326762 123216 90178152
Anosmia 20.74 18.07 5 327074 9843 90291525
Deformity 20.66 18.07 9 327070 12161 90289207
Gastrointestinal stenosis 20.64 18.07 13 327066 281 90301087
Faecaloma 20.63 18.07 6 327073 10425 90290943
Proctitis 20.56 18.07 15 327064 15244 90286124
Photophobia 20.53 18.07 28 327051 21241 90280127
Monocyte count increased 20.41 18.07 4 327075 9093 90292275
Small intestine operation 20.31 18.07 7 327072 33 90301335
Therapy partial responder 20.30 18.07 30 327049 22013 90279355
Muscular weakness 20.24 18.07 926 326153 205740 90095628
Abscess 20.19 18.07 127 326952 18764 90282604
Hypotonia 20.12 18.07 8 327071 11418 90289950
Abortion induced 19.85 18.07 9 327070 11879 90289489
Hydronephrosis 19.77 18.07 10 327069 12392 90288976
Fungal infection 19.69 18.07 83 326996 42578 90258790
Breast cancer female 19.59 18.07 15 327064 14871 90286497
Pulmonary mass 19.59 18.07 47 327032 28725 90272643
Pneumonia viral 19.55 18.07 4 327075 8819 90292549
Post procedural haemorrhage 19.47 18.07 4 327075 8794 90292574
Immune thrombocytopenia 19.44 18.07 12 327067 13314 90288054
Rebound effect 19.30 18.07 5 327074 9379 90291989
Groin pain 19.25 18.07 10 327069 12203 90289165
Panniculitis 19.23 18.07 103 326976 14355 90287013
Gallbladder disorder 19.18 18.07 26 327053 19777 90281591
Sleep disorder due to general medical condition, hypersomnia type 19.08 18.07 30 327049 2049 90299319
Diffuse large B-cell lymphoma 18.99 18.07 4 327075 8641 90292727
Infected dermal cyst 18.92 18.07 15 327064 472 90300896
Medication error 18.89 18.07 419 326660 84233 90217135
Breast pain 18.83 18.07 7 327072 10411 90290957
Product quality issue 18.78 18.07 396 326683 78929 90222439
Drug specific antibody 18.70 18.07 33 327046 2479 90298889
Influenza 18.69 18.07 372 326707 138892 90162476
Incorrect route of product administration 18.56 18.07 271 326808 50355 90251013
Dental caries 18.46 18.07 9 327070 11388 90289980
Respiratory tract infection 18.41 18.07 131 326948 58947 90242421
Signet-ring cell carcinoma 18.40 18.07 6 327073 23 90301345
Muscle strain 18.39 18.07 6 327073 9681 90291687
Wheelchair user 18.39 18.07 3 327076 7782 90293586
Mucous stools 18.32 18.07 51 327028 5220 90296148
Skin lesion 18.31 18.07 71 327008 37294 90264074
Aphonia 18.10 18.07 11 327068 12308 90289060
Hepatomegaly 18.09 18.07 13 327066 13313 90288055

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
Product dose omission issue 3902.02 14.81 2454 53815 151911 42413155
Drug ineffective 1413.14 14.81 2758 53511 627439 41937627
Off label use 781.38 14.81 2211 54058 636124 41928942
Syringe issue 768.90 14.81 322 55947 8234 42556832
Product use issue 728.45 14.81 685 55584 76066 42489000
Psoriasis 573.95 14.81 491 55778 48113 42516953
Therapeutic product effect decreased 570.42 14.81 447 55822 38703 42526363
Inappropriate schedule of product administration 511.39 14.81 631 55638 95271 42469795
Psoriatic arthropathy 445.61 14.81 322 55947 24645 42540421
Needle issue 443.74 14.81 221 56048 8506 42556560
Product storage error 414.81 14.81 229 56040 10911 42554155
Drug eruption 381.05 14.81 284 55985 22791 42542275
Device defective 380.74 14.81 125 56144 1563 42563503
Device issue 348.43 14.81 219 56050 13290 42551776
Treatment failure 304.74 14.81 394 55875 62230 42502836
Acute kidney injury 277.15 14.81 72 56197 367265 42197801
Device deployment issue 269.58 14.81 77 56192 578 42564488
Drug interaction 259.67 14.81 26 56243 266973 42298093
Intestinal resection 247.32 14.81 93 56176 1771 42563295
Hypersensitivity 240.89 14.81 380 55889 71990 42493076
Toxicity to various agents 240.21 14.81 16 56253 229120 42335946
Anal abscess 232.38 14.81 139 56130 7711 42557355
Basal cell carcinoma 228.86 14.81 210 56059 22523 42542543
Synovitis 218.45 14.81 174 56095 15393 42549673
Hepatic function abnormal 213.49 14.81 300 55969 51267 42513799
Hypotension 200.87 14.81 47 56222 257584 42307482
Product leakage 199.61 14.81 64 56205 738 42564328
Febrile neutropenia 197.45 14.81 12 56257 185691 42379375
Therapeutic response decreased 194.37 14.81 242 56027 36770 42528296
Latent tuberculosis 188.46 14.81 74 56195 1591 42563475
Urticaria 185.88 14.81 343 55926 73693 42491373
Ileostomy 163.81 14.81 60 56209 1058 42564008
Tenosynovitis 162.43 14.81 92 56177 4603 42560463
Ileocaecal resection 158.47 14.81 46 56223 368 42564698
Alanine aminotransferase abnormal 150.12 14.81 89 56180 4855 42560211
Neutropenia 148.36 14.81 40 56229 199391 42365675
Faecal calprotectin increased 147.40 14.81 75 56194 3019 42562047
Enthesopathy 146.82 14.81 87 56182 4741 42560325
C-reactive protein abnormal 143.97 14.81 110 56159 9151 42555915
Squamous cell carcinoma 142.61 14.81 126 56143 12856 42552210
Accidental exposure to product 141.64 14.81 154 56115 20239 42544827
Fistula 140.96 14.81 102 56167 7810 42557256
Arthritis 140.01 14.81 221 56048 41844 42523222
Therapeutic product effect incomplete 137.49 14.81 295 55974 70644 42494422
Lower respiratory tract infection 135.10 14.81 215 56054 40991 42524075
Stomatitis 134.94 14.81 240 56029 50089 42514977
Dyspnoea 132.75 14.81 239 56030 442382 42122684
Mycobacterium tuberculosis complex test positive 131.88 14.81 56 56213 1480 42563586
Pyrexia 128.99 14.81 201 56068 393841 42171225
Malignant neoplasm progression 128.69 14.81 3 56266 108397 42456669
Intestinal stenosis 127.87 14.81 66 56203 2738 42562328
Vein rupture 126.81 14.81 48 56221 931 42564135
Abscess 125.00 14.81 122 56147 14126 42550940
Colectomy 121.37 14.81 60 56209 2269 42562797
Muscle spasms 119.21 14.81 314 55955 85730 42479336
Liquid product physical issue 116.98 14.81 43 56226 766 42564300
Death 116.41 14.81 284 55985 470901 42094165
Drug level decreased 109.91 14.81 97 56172 9880 42555186
Somnolence 109.32 14.81 26 56243 141079 42423987
Anaemia 106.67 14.81 128 56141 280150 42284916
Infusion related reaction 106.66 14.81 243 56026 60563 42504503
Tongue disorder 106.53 14.81 74 56195 5309 42559757
Epistaxis 105.19 14.81 256 56013 66570 42498496
Hyponatraemia 103.55 14.81 8 56261 101454 42463612
Frequent bowel movements 102.91 14.81 134 56135 21273 42543793
Drug abuse 102.20 14.81 10 56259 104761 42460305
Arthralgia 101.92 14.81 537 55732 204701 42360365
Device malfunction 101.55 14.81 102 56167 12225 42552841
Therapy non-responder 98.91 14.81 218 56051 53141 42511925
Pancytopenia 98.81 14.81 18 56251 117725 42447341
Asthenia 97.82 14.81 137 56132 280656 42284410
Pain in extremity 95.61 14.81 423 55846 150181 42414885
Anal fistula 94.82 14.81 73 56196 6140 42558926
Thrombocytopenia 94.65 14.81 68 56201 190211 42374855
Intestinal obstruction 93.57 14.81 145 56124 27013 42538053
Platelet count decreased 91.94 14.81 34 56235 138547 42426519
Surgery 88.96 14.81 113 56156 17503 42547563
Inflammatory bowel disease 87.93 14.81 56 56213 3473 42561593
Respiratory failure 87.44 14.81 30 56239 128102 42436964
Completed suicide 87.13 14.81 12 56257 96453 42468613
Hyperkalaemia 86.03 14.81 5 56264 80453 42484613
Tuberculin test positive 85.01 14.81 38 56231 1140 42563926
Ileal stenosis 84.92 14.81 44 56225 1840 42563226
Abdominal abscess 84.71 14.81 63 56206 5030 42560036
Cellulitis 82.47 14.81 222 56047 61363 42503703
Vomiting 80.89 14.81 163 56106 289560 42275506
Hepatic cirrhosis 80.54 14.81 114 56155 19588 42545478
Disease progression 80.11 14.81 45 56224 143611 42421455
Terminal ileitis 79.34 14.81 30 56239 580 42564486
Inflammation 78.87 14.81 152 56117 33695 42531371
Confusional state 78.09 14.81 64 56205 167533 42397533
Drug delivery system malfunction 77.54 14.81 28 56241 473 42564593
Prostate cancer 75.60 14.81 176 56093 44467 42520599
Large intestinal stenosis 74.82 14.81 41 56228 1922 42563144
Gastrointestinal inflammation 74.59 14.81 56 56213 4536 42560530
Bradycardia 74.05 14.81 12 56257 85472 42479594
Abdominal pain 73.35 14.81 466 55803 190005 42375061
Hepatic steatosis 73.16 14.81 114 56155 21334 42543732
Gastrointestinal infection 73.16 14.81 65 56204 6678 42558388
Proctocolectomy 70.66 14.81 21 56248 184 42564882
Underdose 70.45 14.81 98 56171 16568 42548498
Tachycardia 68.39 14.81 24 56245 101063 42464003
Overdose 67.84 14.81 27 56242 105237 42459829
Rhabdomyolysis 67.47 14.81 11 56258 78008 42487058
Oedema peripheral 65.85 14.81 50 56219 136026 42429040
Product packaging issue 65.83 14.81 28 56241 743 42564323
Intestinal fistula 63.23 14.81 31 56238 1151 42563915
Venous injury 62.79 14.81 22 56247 339 42564727
Postoperative wound infection 62.43 14.81 55 56214 5587 42559479
Hypoxia 62.26 14.81 9 56260 69777 42495289
Neutrophil count decreased 61.96 14.81 6 56263 63409 42501657
Small intestinal stenosis 61.76 14.81 28 56241 869 42564197
Skin injury 61.10 14.81 40 56229 2601 42562465
Ileectomy 61.05 14.81 18 56251 153 42564913
White blood cell count decreased 60.93 14.81 35 56234 110361 42454705
Tendonitis 60.61 14.81 70 56199 9824 42555242
Malignant melanoma 60.11 14.81 68 56201 9332 42555734
Cardiac arrest 59.85 14.81 35 56234 109285 42455781
Decreased appetite 59.74 14.81 102 56167 193035 42372031
Erythrodermic psoriasis 59.64 14.81 29 56240 1057 42564009
Postoperative abscess 59.03 14.81 22 56247 408 42564658
Renal failure 58.54 14.81 62 56207 143664 42421402
Headache 58.41 14.81 526 55743 238843 42326223
Clostridium difficile infection 58.07 14.81 106 56163 22553 42542513
Agitation 58.06 14.81 8 56261 64306 42500760
Rectal abscess 57.69 14.81 33 56236 1682 42563384
Tooth abscess 57.58 14.81 57 56212 6711 42558355
Infection 57.41 14.81 296 55973 111772 42453294
Skin plaque 56.72 14.81 53 56216 5810 42559256
Oxygen saturation decreased 56.20 14.81 9 56260 64678 42500388
Multiple organ dysfunction syndrome 56.11 14.81 29 56240 97006 42468060
Haematochezia 55.82 14.81 187 56082 58249 42506817
Loss of therapeutic response 54.90 14.81 29 56240 1262 42563804
Therapy cessation 54.10 14.81 97 56172 20353 42544713
Gastrointestinal haemorrhage 53.90 14.81 31 56238 97695 42467371
Incorrect dose administered 53.72 14.81 173 56096 52801 42512265
Abscess intestinal 53.49 14.81 32 56237 1774 42563292
Tremor 53.10 14.81 31 56238 96898 42468168
Hepatic enzyme increased 52.43 14.81 156 56113 45628 42519438
Hypokalaemia 52.11 14.81 15 56254 71706 42493360
Pleural effusion 51.93 14.81 32 56237 97134 42467932
Constipation 51.76 14.81 84 56185 162207 42402859
Neuropathy peripheral 51.11 14.81 36 56233 101817 42463249
Hepatic fibrosis 50.94 14.81 46 56223 4826 42560240
Haemoglobin decreased 50.82 14.81 60 56209 132411 42432655
Pneumonia lipoid 50.62 14.81 14 56255 92 42564974
Localised infection 50.56 14.81 94 56175 20279 42544787
Drug level below therapeutic 49.99 14.81 52 56217 6493 42558573
Intentional overdose 49.92 14.81 5 56264 51451 42513615
Hidradenitis 49.37 14.81 30 56239 1711 42563355
Arthropathy 49.35 14.81 116 56153 29481 42535585
Drug specific antibody present 48.27 14.81 41 56228 3965 42561101
Injection site papule 47.65 14.81 18 56251 347 42564719
Colitis ulcerative 47.41 14.81 106 56163 26069 42538997
Chikungunya virus infection 47.25 14.81 11 56258 31 42565035
Cytokine release syndrome 46.89 14.81 3 56266 44524 42520542
Dehydration 46.50 14.81 72 56197 141695 42423371
Pustular psoriasis 46.24 14.81 31 56238 2098 42562968
Coma 45.31 14.81 8 56261 53546 42511520
Red blood cell sedimentation rate 45.19 14.81 24 56245 1056 42564010
Delirium 44.09 14.81 8 56261 52511 42512555
Granuloma skin 43.29 14.81 24 56245 1151 42563915
Depressed level of consciousness 43.22 14.81 6 56263 47964 42517102
Blood creatinine increased 41.99 14.81 50 56219 109953 42455113
Anti-cyclic citrullinated peptide antibody positive 41.91 14.81 28 56241 1884 42563182
Pulmonary oedema 40.86 14.81 10 56259 53262 42511804
Hypoglycaemia 40.83 14.81 14 56255 59840 42505226
Bone cyst 40.64 14.81 26 56243 1625 42563441
Joint ankylosis 40.27 14.81 26 56243 1651 42563415
Subcutaneous abscess 40.13 14.81 39 56230 4489 42560577
Intestinal operation 39.70 14.81 14 56255 220 42564846
Insurance issue 39.42 14.81 37 56232 4079 42560987
Pneumonia 39.29 14.81 778 55491 421371 42143695
Dyspnoea exertional 39.28 14.81 9 56260 50139 42514927
International normalised ratio increased 39.04 14.81 8 56261 48160 42516906
Dizziness 38.29 14.81 184 56085 249070 42315996
Drug intolerance 38.14 14.81 208 56061 80216 42484850
Adenocarcinoma of colon 37.65 14.81 35 56234 3812 42561254
Muscle swelling 36.82 14.81 16 56253 448 42564618
Hallucination 36.63 14.81 15 56254 57492 42507574
Myelosuppression 36.59 14.81 5 56264 40456 42524610
Enterocutaneous fistula 36.46 14.81 22 56247 1239 42563827
Stoma creation 36.36 14.81 11 56258 103 42564963
Cardio-respiratory arrest 36.22 14.81 16 56253 58620 42506446
Cutaneous T-cell lymphoma 36.14 14.81 26 56243 1972 42563094
Infected fistula 36.09 14.81 13 56256 218 42564848
Dysphagia 36.08 14.81 26 56243 72693 42492373
Blood parathyroid hormone decreased 35.86 14.81 24 56245 1619 42563447
Carbon dioxide abnormal 35.73 14.81 14 56255 299 42564767
Faecal calprotectin abnormal 35.06 14.81 14 56255 315 42564751
Stenosis 34.96 14.81 26 56243 2075 42562991
Haematocrit decreased 34.91 14.81 3 56266 34905 42530161
No adverse event 34.87 14.81 5 56264 39016 42526050
Aggression 34.44 14.81 8 56261 44155 42520911
Injection site haemorrhage 34.07 14.81 58 56211 11678 42553388
Sacroiliitis 34.05 14.81 25 56244 1957 42563109
Post procedural infection 33.88 14.81 40 56229 5745 42559321
Chills 33.56 14.81 45 56224 94021 42471045
Alcoholic liver disease 33.48 14.81 16 56253 561 42564505
Fall 33.24 14.81 178 56091 234342 42330724
Disability 33.06 14.81 40 56229 5893 42559173
Hepatocellular carcinoma 32.87 14.81 47 56222 8147 42556919
Suicide attempt 32.82 14.81 10 56259 46090 42518976
Gastrointestinal stoma complication 32.26 14.81 22 56247 1531 42563535
Wheezing 32.21 14.81 16 56253 54765 42510301
Tuberculosis 32.12 14.81 52 56217 10047 42555019
Product container seal issue 32.09 14.81 7 56262 13 42565053
Pyoderma gangrenosum 31.97 14.81 24 56245 1943 42563123
Panniculitis 31.92 14.81 25 56244 2156 42562910
Spondyloarthropathy 31.85 14.81 18 56251 896 42564170
Herpes zoster 31.60 14.81 118 56151 38759 42526307
Dry mouth 31.54 14.81 7 56262 39872 42525194
Sporotrichosis 31.23 14.81 9 56260 70 42564996
Small intestinal resection 31.01 14.81 16 56253 663 42564403
Intentional product misuse 30.88 14.81 22 56247 61878 42503188
Lung neoplasm malignant 30.79 14.81 74 56195 19073 42545993
Ankle fracture 30.77 14.81 35 56234 4831 42560235
Hand deformity 30.70 14.81 31 56238 3737 42561329
Atrial fibrillation 30.59 14.81 89 56180 139504 42425562
Periumbilical abscess 30.47 14.81 9 56260 77 42564989
Skin papilloma 30.44 14.81 27 56242 2767 42562299
Abscess limb 30.30 14.81 32 56237 4065 42561001
Mental status changes 30.23 14.81 9 56260 42106 42522960
Angiolymphoid hyperplasia with eosinophilia 30.10 14.81 10 56259 130 42564936
Cutaneous sporotrichosis 29.69 14.81 8 56261 47 42565019
Orthostatic hypotension 29.57 14.81 3 56266 30567 42534499
Blood pressure increased 29.53 14.81 56 56213 101872 42463194
Pityriasis rubra pilaris 29.25 14.81 12 56257 290 42564776
Diarrhoea haemorrhagic 29.16 14.81 43 56226 7664 42557402
Cognitive disorder 29.13 14.81 5 56264 34167 42530899
Fistula discharge 28.65 14.81 18 56251 1090 42563976
Haematuria 28.24 14.81 21 56248 57778 42507288
Prostate infection 28.22 14.81 19 56250 1295 42563771
Altered state of consciousness 27.97 14.81 3 56266 29256 42535810
Infected cyst 27.96 14.81 14 56255 544 42564522
Musculoskeletal stiffness 27.78 14.81 150 56119 57615 42507451
Septic shock 27.77 14.81 49 56220 91623 42473443
Colon cancer 26.99 14.81 47 56222 9634 42555432
Laryngeal cancer 26.97 14.81 15 56254 724 42564342
Rash maculo-papular 26.95 14.81 8 56261 37495 42527571
SARS-CoV-2 test positive 26.91 14.81 43 56226 8217 42556849
Cardiogenic shock 26.73 14.81 7 56262 35633 42529433
Acne 26.69 14.81 57 56212 13587 42551479
Cardiac failure 26.54 14.81 64 56205 106792 42458274
Heart rate increased 26.47 14.81 19 56250 53236 42511830
Haemoptysis 26.38 14.81 14 56255 46153 42518913
Pneumonitis 26.38 14.81 11 56258 41707 42523359
Full blood count abnormal 26.30 14.81 4 56265 29872 42535194
Lymphocyte count decreased 26.21 14.81 3 56266 27806 42537260
Cholelithiasis 26.20 14.81 79 56190 23267 42541799
Nephrolithiasis 26.05 14.81 107 56162 36723 42528343
C-reactive protein increased 25.95 14.81 158 56111 63402 42501664
Unresponsive to stimuli 25.89 14.81 5 56264 31398 42533668
Dermatitis exfoliative generalised 25.74 14.81 35 56234 5789 42559277
Enteritis 25.71 14.81 49 56220 10767 42554299
Blood creatine phosphokinase increased 25.70 14.81 16 56253 48322 42516744
Coronary artery disease 25.63 14.81 20 56249 53700 42511366
Dysuria 25.54 14.81 5 56264 31091 42533975
Anal fissure 25.49 14.81 33 56236 5206 42559860
Nasopharyngitis 25.46 14.81 194 56075 83802 42481264
Tonsil cancer 25.44 14.81 17 56252 1144 42563922
Anastomotic stenosis 25.42 14.81 12 56257 409 42564657
Oedema 25.27 14.81 19 56250 51982 42513084
Hypophagia 25.18 14.81 3 56266 26953 42538113
Onycholysis 25.17 14.81 16 56253 989 42564077
Renal impairment 25.09 14.81 69 56200 110159 42454907
Pneumoretroperitoneum 25.04 14.81 9 56260 150 42564916
Guttate psoriasis 24.88 14.81 13 56256 553 42564513
Melaena 24.85 14.81 10 56259 38736 42526330
Cardiac failure congestive 24.82 14.81 47 56222 85555 42479511
Osteolysis 24.78 14.81 27 56242 3553 42561513
Neoplasm malignant 24.62 14.81 76 56193 22667 42542399
Poor quality product administered 24.54 14.81 22 56247 2286 42562780
Accidental overdose 24.47 14.81 4 56265 28326 42536740
Ventricular tachycardia 24.45 14.81 5 56264 30155 42534911
Gastrointestinal anastomotic stenosis 24.45 14.81 7 56262 53 42565013
Cholangiocarcinoma 24.37 14.81 19 56250 1627 42563439
Small intestinal obstruction 24.34 14.81 63 56206 16998 42548068
Alopecia areata 24.33 14.81 11 56258 339 42564727
Obstruction 24.32 14.81 25 56244 3078 42561988
Contraindication to vaccination 24.16 14.81 6 56263 24 42565042
Gastrointestinal dilation procedure 24.16 14.81 6 56263 24 42565042
Intestinal anastomosis 23.98 14.81 12 56257 466 42564600
Erysipelas 23.64 14.81 35 56234 6261 42558805
Blood glucose increased 23.60 14.81 38 56231 73661 42491405
Myocardial infarction 23.60 14.81 259 56010 123750 42441316
Leukopenia 23.51 14.81 39 56230 74707 42490359
Respiratory distress 23.43 14.81 13 56256 41807 42523259
Restlessness 23.40 14.81 5 56264 29244 42535822
Psychotic disorder 23.36 14.81 5 56264 29203 42535863
Red blood cell sedimentation rate abnormal 23.26 14.81 27 56242 3809 42561257
Rheumatoid nodule 23.24 14.81 24 56245 2971 42562095
Osteosarcoma recurrent 23.21 14.81 8 56261 117 42564949
Lentigo maligna 23.06 14.81 11 56258 384 42564682
Parenteral nutrition 23.01 14.81 13 56256 647 42564419
Mucous stools 22.74 14.81 22 56247 2518 42562548
Diverticulitis 22.73 14.81 74 56195 22699 42542367
Hepatic cytolysis 22.72 14.81 4 56265 26840 42538226
Cholecystectomy 22.58 14.81 25 56244 3349 42561717
Skin cancer 22.55 14.81 48 56221 11414 42553652
Haematemesis 22.52 14.81 6 56263 30193 42534873
Fatigue 22.38 14.81 423 55846 435218 42129848
Incisional hernia 22.34 14.81 17 56252 1405 42563661
Abnormal behaviour 22.26 14.81 4 56265 26447 42538619
Therapy change 21.83 14.81 27 56242 4068 42560998
Energy increased 21.66 14.81 17 56252 1470 42563596
Botryomycosis 21.49 14.81 6 56263 41 42565025
Wrong schedule 21.35 14.81 10 56259 335 42564731
Oral pustule 21.29 14.81 9 56260 235 42564831
Agranulocytosis 21.15 14.81 7 56262 30605 42534461
Asthma 21.04 14.81 31 56238 62283 42502783
Pulmonary embolism 20.94 14.81 84 56185 119528 42445538
Spondylitis 20.87 14.81 17 56252 1551 42563515
Condition aggravated 20.73 14.81 470 55799 260284 42304782
Ventricular fibrillation 20.62 14.81 7 56262 30116 42534950
Gallbladder polyp 20.42 14.81 11 56258 498 42564568
Kidney infection 20.37 14.81 34 56235 6736 42558330
Bone erosion 20.28 14.81 27 56242 4376 42560690
Cholestasis 20.26 14.81 9 56260 32870 42532196
Colostomy closure 20.25 14.81 6 56263 52 42565014
Protein S deficiency 20.15 14.81 7 56262 105 42564961
Meningitis listeria 20.14 14.81 12 56257 660 42564406
Dysgeusia 20.08 14.81 10 56259 34179 42530887
Dysarthria 20.05 14.81 14 56255 39793 42525273
Joint swelling 19.99 14.81 156 56113 67866 42497200
Cholangitis sclerosing 19.97 14.81 18 56251 1884 42563182
Pneumonia aspiration 19.92 14.81 22 56247 50056 42515010
Blood bilirubin increased 19.81 14.81 16 56253 42236 42522830
Large intestine anastomosis 19.66 14.81 6 56263 58 42565008
Renal neoplasm 19.65 14.81 16 56253 1459 42563607
Chronic kidney disease 19.64 14.81 20 56249 47221 42517845
Heart rate decreased 19.55 14.81 12 56257 36520 42528546
Serotonin syndrome 19.53 14.81 5 56264 25840 42539226
Stevens-Johnson syndrome 19.45 14.81 3 56266 22175 42542891
Coagulopathy 19.43 14.81 3 56266 22159 42542907
Tonsillar disorder 19.13 14.81 10 56259 426 42564640
Lung disorder 19.12 14.81 21 56248 47902 42517164
Stoma site abscess 19.05 14.81 6 56263 65 42565001
Circulatory collapse 18.99 14.81 4 56265 23632 42541434
Thyroid cancer 18.97 14.81 17 56252 1766 42563300
Fluid retention 18.94 14.81 9 56260 31610 42533456
Post procedural fistula 18.92 14.81 7 56262 127 42564939
External ear cellulitis 18.87 14.81 4 56265 6 42565060
Wound infection 18.84 14.81 37 56232 8309 42556757
Guillain-Barre syndrome 18.63 14.81 34 56235 7229 42557837
Ileocolostomy 18.61 14.81 5 56264 29 42565037
Seizure 18.47 14.81 89 56180 120472 42444594
Polydipsia 18.38 14.81 26 56243 4462 42560604
Sleep disorder 18.19 14.81 22 56247 48073 42516993
Plasmablastic lymphoma 18.16 14.81 11 56258 624 42564442
Drug level increased 18.09 14.81 6 56263 26194 42538872
Anastomotic ulcer 18.01 14.81 10 56259 481 42564585
Lipids increased 17.97 14.81 14 56255 1198 42563868
Malignant melanoma in situ 17.66 14.81 20 56249 2747 42562319
Sinus tachycardia 17.65 14.81 3 56266 20650 42544416
Hyperbilirubinaemia 17.63 14.81 3 56266 20632 42544434
HIV infection 17.49 14.81 15 56254 1470 42563596
Loss of consciousness 17.36 14.81 63 56206 92291 42472775
Medical device site fistula 17.33 14.81 5 56264 39 42565027
Lupus-like syndrome 17.15 14.81 21 56248 3133 42561933
Skin infection 17.00 14.81 38 56231 9342 42555724
Pulmonary hypertension 16.98 14.81 5 56264 23564 42541502
Blood pressure decreased 16.93 14.81 32 56237 58300 42506766
Rectal cancer 16.82 14.81 18 56251 2322 42562744
Injection site swelling 16.80 14.81 55 56214 16918 42548148
Disorientation 16.79 14.81 14 56255 36375 42528691
Cutaneous symptom 16.78 14.81 9 56260 404 42564662
Encephalopathy 16.62 14.81 18 56251 41315 42523751
Dermatitis psoriasiform 16.46 14.81 17 56252 2105 42562961
Carbuncle 16.42 14.81 5 56264 48 42565018
Adrenal cortex necrosis 16.31 14.81 4 56265 15 42565051
Urinary retention 16.30 14.81 19 56250 42195 42522871
Tinnitus 16.20 14.81 9 56260 28929 42536137
Listeriosis 16.10 14.81 14 56255 1397 42563669
Benign prostatic hyperplasia 16.04 14.81 4 56265 21048 42544018
Hypocalcaemia 16.02 14.81 10 56259 30163 42534903
Drug resistance 16.02 14.81 13 56256 34235 42530831
Pertussis 15.96 14.81 9 56260 446 42564620
Rectal adenocarcinoma 15.96 14.81 12 56257 974 42564092
Red blood cell count decreased 15.83 14.81 12 56257 32703 42532363
Product label issue 15.81 14.81 8 56261 318 42564748
Aphasia 15.80 14.81 6 56263 24077 42540989
Osteonecrosis of jaw 15.77 14.81 3 56266 19046 42546020
Omphalitis 15.73 14.81 4 56265 18 42565048
Diabetic ketoacidosis 15.66 14.81 5 56264 22362 42542704
Adrenal insufficiency 15.63 14.81 3 56266 18921 42546145
Gastrooesophageal reflux disease 15.59 14.81 22 56247 45001 42520065
Cirrhosis alcoholic 15.56 14.81 11 56258 811 42564255
Skin necrosis 15.50 14.81 29 56240 6285 42558781
Full blood count decreased 15.49 14.81 4 56265 20556 42544510
Blood alkaline phosphatase increased 15.41 14.81 13 56256 33584 42531482
Appendicectomy 15.40 14.81 14 56255 1481 42563585
Irritability 15.39 14.81 9 56260 28119 42536947
Ejection fraction decreased 15.35 14.81 5 56264 22082 42542984
Blood potassium decreased 15.29 14.81 4 56265 20380 42544686
Hypothyroidism 15.23 14.81 12 56257 32072 42532994
Autoimmune inner ear disease 15.22 14.81 4 56265 21 42565045
Productive cough 15.22 14.81 28 56241 51539 42513527
Anamnestic reaction 15.19 14.81 5 56264 63 42565003
Pericardial effusion 15.14 14.81 10 56259 29265 42535801
Colectomy total 15.10 14.81 8 56261 350 42564716
Proctitis 15.10 14.81 19 56250 2914 42562152
Listeria sepsis 15.04 14.81 7 56262 231 42564835
Intestinal ulcer 15.02 14.81 12 56257 1065 42564001
Speech disorder 14.99 14.81 10 56259 29111 42535955
Pancreatitis relapsing 14.86 14.81 9 56260 510 42564556
Ascites 14.83 14.81 33 56236 56645 42508421
Upper gastrointestinal haemorrhage 14.81 14.81 11 56258 30288 42534778

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
Product dose omission issue 2875.44 16.02 3922 294518 317860 109972999
Synovitis 1332.56 16.02 2535 295905 271557 110019302
Product use issue 1329.97 16.02 2729 295711 308966 109981893
Acute kidney injury 1298.79 16.02 113 298327 635317 109655542
Hand deformity 1219.95 16.02 2146 296294 216360 110074499
Wound 1206.25 16.02 2222 296218 232215 110058644
Glossodynia 1171.00 16.02 2127 296313 219877 110070982
Syringe issue 1170.16 16.02 553 297887 8972 110281887
Toxicity to various agents 1160.33 16.02 29 298411 480526 109810333
Rheumatoid factor positive 1132.71 16.02 1578 296862 130062 110160797
Drug interaction 1112.07 16.02 58 298382 500125 109790734
Anti-cyclic citrullinated peptide antibody positive 1108.49 16.02 1858 296582 180126 110110733
Systemic lupus erythematosus 1088.09 16.02 2230 296210 252108 110038751
Pemphigus 1072.70 16.02 2009 296431 212561 110078298
Pericarditis 1069.94 16.02 2031 296409 217083 110073776
Rheumatic fever 1016.86 16.02 1444 296996 121135 110169724
Helicobacter infection 1005.48 16.02 1779 296661 180098 110110761
Duodenal ulcer perforation 984.73 16.02 1740 296700 175960 110114899
Hypotension 971.45 16.02 132 298308 523717 109767142
Infusion related reaction 907.09 16.02 2667 295773 378495 109912364
Psoriatic arthropathy 875.39 16.02 1754 296686 195007 110095852
Neutropenia 856.49 16.02 36 298404 374584 109916275
Hepatic enzyme increased 849.73 16.02 2334 296106 318558 109972301
Anaemia 832.62 16.02 224 298216 546862 109743997
Arthropathy 804.01 16.02 2134 296306 285388 110005471
Type 2 diabetes mellitus 801.61 16.02 1591 296849 175641 110115218
Swollen joint count increased 784.64 16.02 1046 297394 82615 110208244
Febrile neutropenia 784.46 16.02 14 298426 316753 109974106
Treatment failure 757.28 16.02 2040 296400 275194 110015665
Folliculitis 750.94 16.02 1499 296941 166154 110124705
Injury 726.73 16.02 1528 296912 175737 110115122
C-reactive protein abnormal 711.80 16.02 1265 297175 128430 110162429
Therapeutic product effect decreased 690.60 16.02 1821 296619 242495 110048364
Irritable bowel syndrome 674.84 16.02 1417 297023 162798 110128061
Discomfort 673.90 16.02 1665 296775 213042 110077817
Fibromyalgia 664.59 16.02 1442 296998 169467 110121392
Hypersensitivity 654.19 16.02 2483 295957 401515 109889344
Death 651.40 16.02 558 297882 698311 109592548
Lip dry 642.72 16.02 1047 297393 99036 110191823
Mobility decreased 625.13 16.02 1724 296716 235698 110055161
Facet joint syndrome 619.14 16.02 1011 297429 95817 110195042
Muscle injury 604.26 16.02 1237 297203 139570 110151289
Psoriasis 599.76 16.02 1229 297211 138764 110152095
Completed suicide 590.85 16.02 13 298427 242368 110048491
Blister 590.62 16.02 1643 296797 225733 110065126
Alopecia 590.52 16.02 2242 296198 362511 109928348
Impaired healing 589.47 16.02 1499 296941 195218 110095641
Somnolence 577.76 16.02 64 298376 297385 109993474
Swelling 569.28 16.02 2159 296281 348882 109941977
Blood cholesterol increased 561.89 16.02 1416 297024 183369 110107490
Joint range of motion decreased 561.86 16.02 1103 297337 120729 110170130
Joint swelling 549.85 16.02 2509 295931 440336 109850523
Lower respiratory tract infection 547.19 16.02 1669 296771 241437 110049422
Sleep disorder due to general medical condition, insomnia type 542.15 16.02 1001 297439 104642 110186217
Needle issue 533.79 16.02 418 298022 17422 110273437
Hyponatraemia 533.17 16.02 11 298429 217642 110073217
Liver injury 509.88 16.02 1202 297238 149211 110141648
Rheumatoid arthritis 501.64 16.02 1862 296578 297751 109993108
Thrombocytopenia 500.75 16.02 159 298281 348726 109942133
Ill-defined disorder 493.67 16.02 1218 297222 155635 110135224
Stomatitis 491.04 16.02 1725 296715 268517 110022342
Abdominal discomfort 486.16 16.02 2228 296212 391630 109899229
Pancytopenia 479.32 16.02 20 298420 209593 110081266
Constipation 474.22 16.02 186 298254 357600 109933259
Platelet count decreased 472.70 16.02 40 298400 230403 110060456
Inflammation 460.56 16.02 1354 297086 191884 110098975
Peripheral venous disease 454.34 16.02 815 297625 83302 110207557
Musculoskeletal stiffness 454.23 16.02 1722 296718 278100 110012759
Off label use 447.62 16.02 6079 292361 1494106 108796753
Drug intolerance 441.21 16.02 2216 296224 404296 109886563
Drug abuse 438.41 16.02 8 298432 177403 110113456
White blood cell count decreased 424.24 16.02 58 298382 229332 110061527
Urticaria 421.32 16.02 1841 296599 317016 109973843
Disease progression 421.19 16.02 75 298365 243959 110046900
Deep vein thrombosis postoperative 417.35 16.02 647 297793 58644 110232215
Road traffic accident 412.52 16.02 902 297538 106496 110184363
Sciatica 409.64 16.02 823 297617 91576 110199283
Device defective 406.30 16.02 201 298239 3621 110287238
Dyspnoea 402.87 16.02 1582 296858 1105290 109185569
Haemoglobin decreased 396.95 16.02 92 298348 248635 110042224
General physical health deterioration 392.94 16.02 2218 296222 423077 109867782
Cardiac arrest 390.54 16.02 39 298401 196714 110094145
Wound infection 389.77 16.02 827 297613 95638 110195221
Lower limb fracture 376.56 16.02 706 297734 74642 110216217
Night sweats 375.48 16.02 996 297444 132987 110157872
Respiratory failure 371.98 16.02 66 298374 215266 110075593
Renal failure 369.21 16.02 80 298360 226494 110064365
Intestinal resection 368.98 16.02 190 298250 3739 110287120
Osteoarthritis 366.93 16.02 1206 297234 181417 110109442
Dehydration 364.26 16.02 149 298291 279362 110011497
Maternal exposure during pregnancy 363.94 16.02 1507 296933 253376 110037483
Bradycardia 361.79 16.02 13 298427 155504 110135355
Product storage error 359.39 16.02 364 298076 21364 110269495
Bursitis 359.23 16.02 961 297479 128957 110161902
Contraindicated product administered 356.92 16.02 1471 296969 246796 110044063
Autoimmune disorder 356.85 16.02 637 297803 64846 110226013
Oxygen saturation decreased 355.50 16.02 16 298424 156966 110133893
Exposure during pregnancy 351.13 16.02 1122 297318 166302 110124557
Hypokalaemia 342.44 16.02 44 298396 182404 110108455
Cough 336.60 16.02 452 297988 461189 109829670
Tremor 336.51 16.02 68 298372 202164 110088695
Grip strength decreased 332.79 16.02 695 297745 79479 110211380
Hyperkalaemia 331.97 16.02 7 298433 135789 110155070
Sepsis 331.33 16.02 240 298200 327106 109963753
Obesity 329.20 16.02 854 297586 112497 110178362
Neuropathy peripheral 325.22 16.02 48 298392 179229 110111630
Sleep disorder 323.42 16.02 1224 297216 197420 110093439
Breast cancer stage III 320.44 16.02 679 297761 78438 110212421
Adjustment disorder with depressed mood 317.44 16.02 485 297955 43398 110247461
Atrial fibrillation 316.55 16.02 112 298328 229530 110061329
X-ray abnormal 314.25 16.02 448 297992 37669 110253190
Fall 312.56 16.02 732 297708 602750 109688109
Gastrointestinal haemorrhage 310.43 16.02 40 298400 165478 110125381
Gait inability 310.03 16.02 940 297500 135436 110155423
Intentional overdose 308.48 16.02 11 298429 132490 110158369
Pleural effusion 307.94 16.02 54 298386 177655 110113204
Hypoxia 307.77 16.02 9 298431 129506 110161353
Hypoaesthesia 302.12 16.02 1657 296783 312566 109978293
Sinusitis 301.16 16.02 1588 296852 295100 109995759
Adverse event 299.91 16.02 804 297636 108005 110182854
Hypercholesterolaemia 299.12 16.02 718 297722 90119 110200740
Gastrointestinal disorder 293.90 16.02 1363 297077 240589 110050270
Neutrophil count decreased 292.65 16.02 7 298433 120934 110169925
Hip arthroplasty 285.15 16.02 528 297912 55285 110235574
Multiple organ dysfunction syndrome 281.31 16.02 38 298402 151672 110139187
Dislocation of vertebra 277.30 16.02 455 297985 43266 110247593
Drug ineffective 277.06 16.02 5688 292752 1514852 108776007
Live birth 272.94 16.02 589 297851 68895 110221964
Device issue 271.69 16.02 397 298043 34138 110256721
Retinitis 270.99 16.02 383 298057 31944 110258915
Rhabdomyolysis 270.24 16.02 13 298427 120388 110170471
Cardiac failure 269.95 16.02 85 298355 187541 110103318
Chills 269.49 16.02 89 298351 190491 110100368
Electrocardiogram QT prolonged 268.81 16.02 5 298435 108955 110181904
Inappropriate schedule of product administration 268.13 16.02 1175 297265 202462 110088397
Dry mouth 261.95 16.02 1152 297288 198796 110092063
Pulmonary embolism 257.99 16.02 128 298312 214346 110076513
Bone erosion 257.67 16.02 455 297985 45916 110244943
Coma 257.43 16.02 15 298425 117854 110173005
Lupus-like syndrome 256.66 16.02 423 298017 40369 110250490
Depressed level of consciousness 255.67 16.02 11 298429 112267 110178592
Nasopharyngitis 255.10 16.02 1880 296560 392481 109898378
Agitation 254.40 16.02 12 298428 113039 110177820
Hepatic cirrhosis 249.49 16.02 559 297881 67067 110223792
Renal impairment 247.82 16.02 99 298341 188346 110102513
Seizure 247.06 16.02 145 298295 221040 110069819
Exostosis 245.19 16.02 443 297997 45513 110245346
Hypoglycaemia 241.21 16.02 19 298421 116085 110174774
C-reactive protein 237.63 16.02 348 298092 29983 110260876
Back pain 235.72 16.02 399 298041 370597 109920262
Hyperhidrosis 234.14 16.02 106 298334 187192 110103667
Myelosuppression 234.08 16.02 4 298436 94336 110196523
Cardio-respiratory arrest 232.36 16.02 22 298418 115814 110175045
Prescribed overdose 230.19 16.02 636 297804 86945 110203914
Therapy non-responder 229.02 16.02 936 297504 156371 110134488
Knee arthroplasty 228.64 16.02 527 297913 64421 110226438
Liver disorder 222.83 16.02 866 297574 141377 110149482
Lung disorder 222.04 16.02 1019 297421 179028 110111831
Cardiac failure congestive 217.93 16.02 68 298372 150932 110139927
Infection 215.85 16.02 1694 296746 360506 109930353
Overdose 212.02 16.02 191 298249 233603 110057256
Dyspnoea exertional 208.09 16.02 20 298420 104040 110186819
International normalised ratio increased 206.27 16.02 6 298434 86766 110204093
Product leakage 205.06 16.02 96 298344 1522 110289337
Hallucination 204.15 16.02 19 298421 101413 110189446
Syncope 202.88 16.02 150 298290 202386 110088473
Heart rate increased 201.88 16.02 68 298372 143766 110147093
Cognitive disorder 201.17 16.02 8 298432 87503 110203356
Balance disorder 198.49 16.02 37 298403 116523 110174336
Anal abscess 196.18 16.02 197 298243 11441 110279418
Loss of consciousness 195.84 16.02 146 298294 196160 110094699
Septic shock 195.57 16.02 90 298350 157438 110133421
Lupus vulgaris 195.44 16.02 338 298102 33545 110257314
Blood creatinine increased 194.38 16.02 127 298313 182762 110108097
Suicide attempt 193.82 16.02 25 298415 103369 110187490
Wheezing 193.35 16.02 1265 297175 253965 110036894
Pulmonary oedema 191.96 16.02 23 298417 100636 110190223
Drug reaction with eosinophilia and systemic symptoms 190.44 16.02 7 298433 82088 110208771
Hyperglycaemia 188.37 16.02 10 298430 85080 110205779
Interstitial lung disease 183.51 16.02 73 298367 139261 110151598
Device deployment issue 182.61 16.02 124 298316 4129 110286730
Laryngitis 182.24 16.02 373 298067 42038 110248821
Musculoskeletal pain 178.31 16.02 969 297471 182054 110108805
Blood glucose increased 175.18 16.02 69 298371 132427 110158432
Adverse drug reaction 174.63 16.02 654 297786 104905 110185954
Cytokine release syndrome 174.35 16.02 3 298437 70303 110220556
Blood pressure increased 173.31 16.02 268 298172 258105 110032754
Enthesopathy 170.75 16.02 189 298251 12289 110278570
Leukopenia 169.76 16.02 95 298345 148696 110142163
Tachycardia 169.00 16.02 218 298222 226427 110064432
Joint dislocation 167.84 16.02 318 298122 33872 110256987
Productive cough 167.60 16.02 50 298390 114255 110176604
Blepharospasm 167.21 16.02 421 298019 54430 110236429
Blood pressure decreased 165.77 16.02 52 298388 115039 110175820
Arthritis 165.09 16.02 890 297550 166696 110124163
Anti-cyclic citrullinated peptide antibody 165.06 16.02 235 298205 19729 110271130
Haematocrit decreased 163.22 16.02 3 298437 66114 110224745
Colectomy 160.81 16.02 116 298324 4262 110286597
Nausea 160.40 16.02 2360 296080 1233330 109057529
Deep vein thrombosis 160.04 16.02 89 298351 139798 110151061
Nail disorder 159.49 16.02 428 298012 57507 110233352
Neoplasm progression 159.18 16.02 3 298437 64592 110226267
Blood bilirubin increased 156.23 16.02 13 298427 75959 110214900
Urinary tract infection 152.95 16.02 416 298024 325866 109964993
Mental status changes 151.23 16.02 15 298425 76107 110214752
Foot deformity 150.82 16.02 375 298065 48105 110242754
Angioedema 150.14 16.02 40 298400 98460 110192399
Feeling abnormal 149.54 16.02 160 298280 180551 110110308
Encephalopathy 148.59 16.02 21 298419 81034 110209825
Mucosal inflammation 148.53 16.02 38 298402 96103 110194756
Ileostomy 148.36 16.02 88 298352 2304 110288555
Frequent bowel movements 148.25 16.02 477 297963 70913 110219946
Heart rate decreased 148.11 16.02 23 298417 82733 110208126
Basal cell carcinoma 148.09 16.02 357 298083 44913 110245946
Blood pressure fluctuation 147.98 16.02 15 298425 74809 110216050
Intentional product use issue 147.30 16.02 1159 297281 246747 110044112
Injection site pain 146.70 16.02 158 298282 177764 110113095
Onychomadesis 146.06 16.02 357 298083 45306 110245553
Myalgia 145.97 16.02 234 298206 222147 110068712
Liquid product physical issue 143.43 16.02 75 298365 1525 110289334
Respiratory arrest 142.49 16.02 3 298437 58296 110232563
Pulmonary fibrosis 142.05 16.02 599 297841 101443 110189416
Rash maculo-papular 141.42 16.02 17 298423 74205 110216654
Ascites 140.87 16.02 38 298402 92770 110198089
Hypomagnesaemia 140.54 16.02 5 298435 60365 110230494
Pustular psoriasis 139.74 16.02 178 298262 13427 110277432
Unresponsive to stimuli 139.64 16.02 8 298432 63782 110227077
Haemoptysis 139.33 16.02 15 298425 71339 110219520
Melaena 138.04 16.02 13 298427 68744 110222115
Disorientation 137.63 16.02 15 298425 70656 110220203
Altered state of consciousness 136.91 16.02 4 298436 57622 110233237
Intentional product misuse 134.93 16.02 97 298343 132807 110158052
Neurologic neglect syndrome 134.47 16.02 145 298295 9153 110281706
Red blood cell sedimentation rate increased 134.41 16.02 491 297949 77811 110213048
Aggression 134.13 16.02 6 298434 59204 110231655
Cholestasis 132.78 16.02 11 298429 64507 110226352
Lymphocyte count decreased 132.36 16.02 5 298435 57238 110233621
Pneumonia aspiration 131.62 16.02 29 298411 81204 110209655
Agranulocytosis 131.44 16.02 9 298431 61751 110229108
Muscle spasms 131.44 16.02 1236 297204 276921 110013938
Serotonin syndrome 130.78 16.02 7 298433 59146 110231713
Urinary retention 130.24 16.02 17 298423 69666 110221193
Carotid artery thrombosis 130.18 16.02 145 298295 9493 110281366
Cardiogenic shock 129.27 16.02 6 298434 57332 110233527
Coronary artery disease 128.13 16.02 20 298420 71670 110219189
Hypocalcaemia 126.97 16.02 14 298426 65352 110225507
Pneumonitis 126.70 16.02 26 298414 76505 110214354
Restlessness 126.47 16.02 6 298434 56253 110234606
Full blood count abnormal 125.94 16.02 6 298434 56046 110234813
Red blood cell count decreased 125.85 16.02 15 298425 65908 110224951
Hepatic failure 125.56 16.02 18 298422 68721 110222138
Contusion 124.62 16.02 1065 297375 232296 110058563
Pregnancy 123.57 16.02 360 298080 50707 110240152
Shock 122.82 16.02 5 298435 53583 110237276
Acute respiratory failure 121.67 16.02 27 298413 75233 110215626
Migraine 121.64 16.02 837 297603 170815 110120044
Respiratory distress 121.33 16.02 20 298420 68854 110222005
Drug eruption 121.05 16.02 369 298071 53290 110237569
Chronic kidney disease 120.09 16.02 29 298411 76262 110214597
Orthostatic hypotension 119.50 16.02 18 298422 66231 110224628
Pyrexia 118.93 16.02 1708 296732 896557 109394302
C-reactive protein increased 118.72 16.02 999 297441 216920 110073939
Alanine aminotransferase abnormal 118.54 16.02 136 298304 9198 110281661
Hypothyroidism 118.16 16.02 26 298414 72873 110217986
Tenosynovitis 117.79 16.02 180 298260 16103 110274756
Drug delivery system malfunction 117.71 16.02 57 298383 978 110289881
Thrombosis 117.43 16.02 74 298366 108588 110182271
Dyskinesia 117.25 16.02 5 298435 51441 110239418
Ileocaecal resection 117.01 16.02 48 298392 543 110290316
Disturbance in attention 116.16 16.02 15 298425 61980 110228879
Oedema 115.14 16.02 964 297476 209012 110081847
Blood alkaline phosphatase increased 113.57 16.02 26 298414 70909 110219950
Suicidal ideation 113.01 16.02 56 298384 93881 110196978
Intestinal stenosis 112.76 16.02 97 298343 4618 110286241
Adjustment disorder 112.08 16.02 142 298298 10653 110280206
Hypervolaemia 112.08 16.02 5 298435 49455 110241404
Blood creatine phosphokinase increased 110.76 16.02 30 298410 73047 110217812
Obstructive airways disorder 110.39 16.02 3 298437 46146 110244713
Haematemesis 109.09 16.02 15 298425 59093 110231766
Product label confusion 108.94 16.02 209 298231 22468 110268391
Back injury 108.85 16.02 328 298112 47071 110243788
Osteonecrosis of jaw 108.33 16.02 5 298435 48012 110242847
Hypophagia 108.22 16.02 9 298431 52617 110238242
Weight increased 108.14 16.02 1661 296779 417983 109872876
Toxic epidermal necrolysis 108.06 16.02 13 298427 56714 110234145
Tinnitus 107.94 16.02 17 298423 60523 110230336
Lethargy 107.81 16.02 59 298381 93517 110197342
Breast cancer stage II 107.41 16.02 232 298208 27143 110263716
Pain in jaw 107.35 16.02 8 298432 51169 110239690
Ventricular tachycardia 107.27 16.02 7 298433 50002 110240857
Dysuria 107.20 16.02 17 298423 60214 110230645
Jaundice 107.06 16.02 16 298424 59220 110231639
Ear infection 106.52 16.02 392 298048 62340 110228519
Hepatic cytolysis 106.41 16.02 12 298428 55041 110235818
Hepatocellular injury 105.99 16.02 8 298432 50634 110240225
Vision blurred 105.88 16.02 115 298325 128907 110161952
Dysgeusia 105.57 16.02 29 298411 69956 110220903
Haematuria 105.24 16.02 46 298394 82959 110207900
Tongue disorder 104.76 16.02 159 298281 14139 110276720
Eye pain 104.61 16.02 8 298432 50091 110240768
Underdose 104.46 16.02 393 298047 63161 110227698
Accidental exposure to product 103.70 16.02 334 298106 49674 110241185
Blood urea increased 103.69 16.02 13 298427 54944 110235915
Stevens-Johnson syndrome 102.30 16.02 6 298434 46895 110243964
Therapeutic response decreased 102.22 16.02 523 297917 95976 110194883
Irritability 101.65 16.02 7 298433 47802 110243057
Latent tuberculosis 101.64 16.02 85 298355 3892 110286967
Dyspepsia 99.57 16.02 867 297573 190098 110100761
Onychomycosis 99.42 16.02 278 298162 38253 110252606
Arrhythmia 99.18 16.02 32 298408 69543 110221316
Walking aid user 98.95 16.02 213 298227 24862 110265997
Porphyria acute 98.84 16.02 180 298260 18600 110272259
Finger deformity 98.77 16.02 252 298188 32840 110258019
Haematoma 98.62 16.02 19 298421 58457 110232402
Cerebral haemorrhage 97.85 16.02 27 298413 64941 110225918
Haemorrhage 95.68 16.02 88 298352 106604 110184255
Cardiac disorder 95.56 16.02 43 298397 76237 110214622
Arthralgia 95.16 16.02 2765 295675 776867 109513992
Therapeutic product effect incomplete 94.71 16.02 972 297468 222833 110068026
Personality disorder 94.40 16.02 143 298297 12694 110278165
Ventricular fibrillation 94.20 16.02 4 298436 41309 110249550
Generalised tonic-clonic seizure 93.85 16.02 17 298423 54663 110236196
Sinus tachycardia 93.20 16.02 7 298433 44486 110246373
Diabetic ketoacidosis 92.91 16.02 5 298435 42053 110248806
Erythema 92.90 16.02 437 298003 291010 109999849
Urinary incontinence 92.88 16.02 11 298429 48576 110242283
Peripheral swelling 92.76 16.02 1569 296871 402465 109888394
Faecal calprotectin increased 92.33 16.02 102 298338 6617 110284242
Upper gastrointestinal haemorrhage 91.77 16.02 13 298427 50083 110240776
Pericardial effusion 91.54 16.02 21 298419 57196 110233663
Drug level increased 90.74 16.02 11 298429 47708 110243151
Liver function test increased 90.39 16.02 475 297965 88073 110202786
Diarrhoea 90.00 16.02 2365 296075 1137140 109153719
Squamous cell carcinoma 89.72 16.02 171 298269 18292 110272567
Circulatory collapse 89.39 16.02 7 298433 42986 110247873
Pulmonary hypertension 88.88 16.02 20 298420 55200 110235659
Prescribed underdose 88.69 16.02 380 298060 64794 110226065
Drug tolerance decreased 87.74 16.02 215 298225 27325 110263534
Drug resistance 87.62 16.02 22 298418 56352 110234507
Spondylitis 87.23 16.02 129 298311 11209 110279650
Coagulopathy 86.95 16.02 6 298434 40905 110249954
Ejection fraction decreased 86.87 16.02 6 298434 40874 110249985
Tubulointerstitial nephritis 86.70 16.02 20 298420 54264 110236595
Acute myocardial infarction 86.54 16.02 60 298380 83717 110207142
Ileal stenosis 85.88 16.02 71 298369 3199 110287660
Leukocytosis 85.63 16.02 20 298420 53808 110237051
Injection site erythema 85.25 16.02 77 298363 94099 110196760
Abnormal behaviour 85.13 16.02 5 298435 39034 110251825
Accidental overdose 85.00 16.02 18 298422 51816 110239043
Drug dependence 84.89 16.02 16 298424 50004 110240855
Bone pain 84.32 16.02 35 298405 65098 110225761
Pallor 84.05 16.02 24 298416 56443 110234416
Red blood cell sedimentation rate 83.76 16.02 86 298354 5128 110285731
Skin haemorrhage 83.58 16.02 198 298242 24629 110266230
Taste disorder 83.47 16.02 374 298066 65013 110225846
Inflammatory bowel disease 82.90 16.02 100 298340 7134 110283725
Neurotoxicity 82.08 16.02 9 298431 42198 110248661
Nightmare 81.73 16.02 6 298434 38857 110252002
Acute hepatic failure 81.62 16.02 4 298436 36464 110254395
Weight decreased 80.75 16.02 840 297600 467217 109823642
Seronegative arthritis 80.67 16.02 135 298305 13042 110277817
Hepatotoxicity 80.58 16.02 35 298405 63365 110227494
Rectal abscess 80.27 16.02 63 298377 2633 110288226
Lip swelling 80.26 16.02 19 298421 50648 110240211
Myocardial infarction 79.77 16.02 259 298181 191824 110099035
Anal fistula 79.46 16.02 106 298334 8367 110282492
Oropharyngeal pain 79.08 16.02 153 298287 135123 110155736
Sinus congestion 78.82 16.02 220 298220 30239 110260620
Blood potassium decreased 78.72 16.02 24 298416 54090 110236769
Eosinophilia 78.52 16.02 29 298411 57907 110232952
Rash erythematous 77.61 16.02 64 298376 81768 110209091
Joint stiffness 77.28 16.02 373 298067 66870 110223989
Maternal exposure timing unspecified 76.69 16.02 173 298267 20840 110270019
Chronic obstructive pulmonary disease 76.28 16.02 110 298330 109048 110181811
Adverse reaction 75.84 16.02 213 298227 29381 110261478
Product quality issue 75.72 16.02 410 298030 76889 110213970
Large intestinal stenosis 75.03 16.02 70 298370 3710 110287149
Dysphonia 75.01 16.02 57 298383 75872 110214987
Acute respiratory distress syndrome 74.89 16.02 25 298415 53173 110237686
Anaphylactic shock 74.73 16.02 23 298417 51523 110239336
Nasal congestion 73.77 16.02 94 298346 98188 110192671
Speech disorder 73.61 16.02 37 298403 61532 110229327
No adverse event 73.50 16.02 55 298385 73784 110217075
Abdominal pain upper 73.40 16.02 1337 297103 347774 109943085
Rash 73.34 16.02 2807 295633 818157 109472702
Disability 73.06 16.02 213 298227 30010 110260849
Bronchiectasis 72.99 16.02 7 298433 36486 110254373
Oral pain 72.77 16.02 8 298432 37436 110253423
Intentional self-injury 72.74 16.02 8 298432 37421 110253438
Blood sodium decreased 72.45 16.02 9 298431 38310 110252549
Muscle spasticity 70.98 16.02 236 298204 35679 110255180
Atelectasis 70.96 16.02 8 298432 36704 110254155
Disseminated intravascular coagulation 70.50 16.02 13 298427 41273 110249586
Tumour lysis syndrome 70.17 16.02 3 298437 30798 110260061
Vomiting 69.97 16.02 1897 296543 908778 109382081
Femur fracture 69.80 16.02 17 298423 44452 110246407
Drug withdrawal syndrome 69.42 16.02 10 298430 38044 110252815
Tendonitis 69.08 16.02 190 298250 25893 110264966
Drug hypersensitivity 68.69 16.02 1657 296783 452433 109838426
Swelling face 68.57 16.02 89 298351 92232 110198627
Flushing 67.95 16.02 111 298329 104625 110186234
Mitral valve incompetence 67.71 16.02 6 298434 33323 110257536
Aspartate aminotransferase increased 67.56 16.02 214 298226 159722 110131137
Troponin increased 67.48 16.02 3 298437 29763 110261096
Fistula 67.43 16.02 136 298304 15163 110275696
Cyanosis 67.41 16.02 3 298437 29738 110261121
Full blood count decreased 67.37 16.02 5 298435 32094 110258765
Swollen joint count 67.18 16.02 99 298341 8575 110282284
Gangrene 67.00 16.02 141 298299 16200 110274659
Myoclonus 66.88 16.02 6 298434 32992 110257867
Arterial occlusive disease 66.19 16.02 135 298305 15173 110275686
Neuralgia 66.14 16.02 24 298416 48454 110242405
Memory impairment 65.91 16.02 817 297623 196127 110094732
Cutaneous T-cell lymphoma 65.89 16.02 62 298378 3322 110287537
Alanine aminotransferase increased 65.58 16.02 264 298176 183509 110107350
Subdural haematoma 65.53 16.02 10 298430 36444 110254415
Pollakiuria 65.38 16.02 19 298421 44176 110246683
Swollen tongue 65.36 16.02 41 298399 60321 110230538
Terminal ileitis 65.03 16.02 46 298394 1638 110289221
Blood pressure systolic increased 64.79 16.02 77 298363 82914 110207945
Electrolyte imbalance 64.67 16.02 11 298429 37017 110253842
Bronchopulmonary aspergillosis 64.59 16.02 4 298436 29859 110261000
Blood calcium decreased 64.05 16.02 10 298430 35835 110255024
Lymphopenia 63.75 16.02 15 298425 40155 110250704
Amnesia 63.75 16.02 495 297945 104913 110185946
Presyncope 63.72 16.02 26 298414 48861 110241998
Small intestinal resection 63.35 16.02 39 298401 1094 110289765
Abscess intestinal 63.31 16.02 60 298380 3244 110287615
Vertigo 63.24 16.02 85 298355 86785 110204074
Cytopenia 62.34 16.02 5 298435 30111 110260748
Visual acuity reduced 62.21 16.02 7 298433 32166 110258693
Affect lability 62.05 16.02 148 298292 18489 110272370
Gastrointestinal inflammation 62.00 16.02 100 298340 9369 110281490
Palpitations 61.80 16.02 221 298219 158991 110131868
Ileectomy 61.73 16.02 25 298415 273 110290586
Dry eye 61.66 16.02 37 298403 55756 110235103
Drug level decreased 61.44 16.02 147 298293 18401 110272458
Ulcer haemorrhage 61.36 16.02 166 298274 22405 110268454
Plasma cell myeloma 61.21 16.02 48 298392 62888 110227971
Sinus bradycardia 60.74 16.02 5 298435 29478 110261381
Gastritis 60.21 16.02 35 298405 53664 110237195
Blood potassium increased 60.04 16.02 9 298431 33240 110257619
Poisoning 59.78 16.02 5 298435 29100 110261759
Hyperlipidaemia 59.71 16.02 12 298428 35836 110255023
Proteinuria 59.58 16.02 17 298423 40001 110250858
Haemorrhage intracranial 59.44 16.02 5 298435 28964 110261895
Skin discolouration 59.35 16.02 29 298411 49017 110241842
Sacroiliitis 58.99 16.02 70 298370 4908 110285951
Abdominal abscess 58.93 16.02 94 298346 8725 110282134
Device dislocation 58.61 16.02 8 298432 31696 110259163
Pneumocystis jirovecii pneumonia 58.57 16.02 21 298419 42714 110248145
Hyperbilirubinaemia 58.49 16.02 7 298433 30664 110260195
Nephropathy toxic 58.48 16.02 4 298436 27474 110263385
Product packaging issue 58.48 16.02 43 298397 1628 110289231
Nervousness 58.01 16.02 14 298426 36837 110254022
Metastases to bone 57.80 16.02 8 298432 31364 110259495
Sensory loss 57.52 16.02 157 298283 21300 110269559
Subcutaneous drug absorption impaired 57.29 16.02 86 298354 7573 110283286
Illness 57.22 16.02 83 298357 82088 110208771
Dysphagia 57.13 16.02 217 298223 153383 110137476
Diplopia 56.72 16.02 21 298419 41873 110248986
Abscess 56.52 16.02 183 298257 27286 110263573
Neutropenic sepsis 56.27 16.02 8 298432 30738 110260121
Pulmonary arterial hypertension 56.16 16.02 10 298430 32558 110258301
Psychotic disorder 55.98 16.02 34 298406 50903 110239956
Status epilepticus 55.98 16.02 9 298431 31562 110259297
Blood test abnormal 55.75 16.02 6 298434 28548 110262311
Respiratory rate increased 55.35 16.02 3 298437 25080 110265779
Coeliac disease 55.10 16.02 247 298193 42940 110247919
Neutrophil count increased 54.87 16.02 13 298427 34639 110256220
Postoperative abscess 54.86 16.02 33 298407 887 110289972
Mouth ulceration 54.51 16.02 31 298409 48107 110242752
Rales 54.46 16.02 3 298437 24736 110266123
Hypertension 54.09 16.02 1779 296661 508305 109782554
Oesophagitis 53.67 16.02 7 298433 28708 110262151
Osteoporosis 53.66 16.02 411 298029 86741 110204118
Cytomegalovirus infection 53.61 16.02 41 298399 54403 110236456
Erythrodermic psoriasis 53.53 16.02 44 298396 1966 110288893
Feeling cold 53.33 16.02 13 298427 33974 110256885
Blood glucose decreased 53.21 16.02 8 298432 29480 110261379
Chromaturia 52.90 16.02 8 298432 29352 110261507
Dry skin 52.87 16.02 134 298306 107519 110183340
Epilepsy 52.74 16.02 456 297984 99753 110191106
Body temperature decreased 52.62 16.02 17 298423 36918 110253941
Arteriosclerosis coronary artery 52.47 16.02 4 298436 25114 110265745
Asthenia 52.38 16.02 1437 297003 687562 109603297
Depressed mood 52.36 16.02 52 298388 60757 110230102
Myopathy 52.07 16.02 4 298436 24956 110265903
Blood pressure diastolic decreased 52.04 16.02 16 298424 35869 110254990
Delusion 51.93 16.02 3 298437 23752 110267107
Product container seal issue 51.80 16.02 18 298422 123 110290736
Generalised oedema 51.72 16.02 10 298430 30694 110260165
Vein rupture 51.72 16.02 48 298392 2527 110288332
Renal disorder 51.68 16.02 35 298405 49444 110241415
Hypophosphataemia 51.47 16.02 13 298427 33169 110257690
Clostridium difficile colitis 51.30 16.02 27 298413 43751 110247108
Restless legs syndrome 51.22 16.02 4 298436 24622 110266237
Aspergillus infection 51.00 16.02 5 298435 25611 110265248
Loss of therapeutic response 50.82 16.02 47 298393 2463 110288396
Petechiae 50.80 16.02 3 298437 23314 110267545
Purpura 50.62 16.02 4 298436 24384 110266475
Brain oedema 50.58 16.02 11 298429 31087 110259772
Hypoacusis 50.48 16.02 16 298424 35175 110255684
Breath sounds abnormal 50.47 16.02 5 298435 25399 110265460
Nodule 50.20 16.02 13 298427 32618 110258241
Eye irritation 50.19 16.02 14 298426 33438 110257421
Thrombotic microangiopathy 50.16 16.02 9 298431 29140 110261719
Diabetes mellitus 50.13 16.02 122 298318 99259 110191600
Burning sensation 50.09 16.02 68 298372 69144 110221715
Blindness 49.61 16.02 18 298422 36341 110254518
Metastases to liver 49.17 16.02 17 298423 35369 110255490
Blood parathyroid hormone decreased 49.16 16.02 109 298331 12980 110277879
Bronchospasm 48.57 16.02 11 298429 30228 110260631
Eczema 48.42 16.02 75 298365 72218 110218641
Colitis ulcerative 48.28 16.02 366 298074 76997 110213862
Hemiplegia 47.99 16.02 153 298287 22629 110268230
Grip strength 47.33 16.02 87 298353 9054 110281805
Myelodysplastic syndrome 47.15 16.02 21 298419 37463 110253396
Intestinal operation 47.12 16.02 26 298414 591 110290268
Muscle rigidity 47.04 16.02 5 298435 24026 110266833
Throat irritation 47.03 16.02 45 298395 53507 110237352
Metastases to central nervous system 46.64 16.02 4 298436 22813 110268046
Ocular hyperaemia 46.38 16.02 24 298416 39262 110251597
Toxic skin eruption 46.27 16.02 9 298431 27506 110263353
Cardiac murmur 46.04 16.02 6 298434 24622 110266237
Granuloma skin 45.85 16.02 97 298343 11186 110279673
Transfusion 45.76 16.02 7 298433 25465 110265394
Body temperature increased 45.73 16.02 48 298392 54665 110236194
Bacteraemia 45.61 16.02 29 298411 42361 110248498
Cerebral infarction 45.01 16.02 44 298396 51794 110239065
Face oedema 44.94 16.02 17 298423 33452 110257407
Pancreatitis acute 44.87 16.02 58 298382 60216 110230643
Stress 44.45 16.02 141 298299 105207 110185652
Fluid retention 44.31 16.02 120 298320 94187 110196672
Intestinal fistula 44.21 16.02 37 298403 1696 110289163
Anastomotic stenosis 44.20 16.02 26 298414 670 110290189
Haemophagocytic lymphohistiocytosis 44.13 16.02 15 298425 31544 110259315
Hepatic encephalopathy 43.96 16.02 11 298429 28245 110262614
Dysstasia 43.88 16.02 17 298423 32969 110257890
Skin plaque 43.82 16.02 102 298338 12543 110278316
Premature delivery 43.81 16.02 14 298426 30618 110260241
Candida infection 43.75 16.02 39 298401 47970 110242889
Retching 43.69 16.02 5 298435 22677 110268182
Gamma-glutamyltransferase increased 43.60 16.02 61 298379 61248 110229611
Shock haemorrhagic 43.59 16.02 10 298430 27237 110263622
Product administration error 43.54 16.02 23 298417 37194 110253665
COVID-19 43.36 16.02 437 298003 244623 110046236
Psychomotor hyperactivity 43.01 16.02 3 298437 20274 110270585
Injection site pruritus 42.81 16.02 45 298395 51213 110239646
Fear 42.53 16.02 6 298434 23187 110267672
Atrioventricular block complete 42.52 16.02 3 298437 20079 110270780
Cardiac failure acute 42.39 16.02 7 298433 24071 110266788
Dizziness 42.39 16.02 1500 296940 696693 109594166
Myocardial ischaemia 42.28 16.02 10 298430 26674 110264185
Cardiomegaly 42.22 16.02 13 298427 29117 110261742
Hypoalbuminaemia 41.87 16.02 13 298427 28961 110261898
Gastric ulcer 41.83 16.02 28 298412 39799 110251060
Polyneuropathy 41.76 16.02 17 298423 31995 110258864
Panniculitis 41.76 16.02 114 298326 15468 110275391
Joint ankylosis 41.59 16.02 42 298398 2455 110288404
Schizophrenia 41.57 16.02 5 298435 21821 110269038
Intestinal obstruction 41.57 16.02 266 298174 52961 110237898
Sputum discoloured 41.36 16.02 12 298428 27933 110262926
Bacterial infection 41.23 16.02 38 298402 45998 110244861
Macular degeneration 41.16 16.02 5 298435 21654 110269205
Pseudomonas infection 41.15 16.02 12 298428 27841 110263018
Pulmonary congestion 41.13 16.02 16 298424 30950 110259909
Chronic sinusitis 40.54 16.02 9 298431 25075 110265784
Device malfunction 40.31 16.02 156 298284 25402 110265457
Motor dysfunction 40.16 16.02 151 298289 24255 110266604
Procedural pain 40.13 16.02 23 298417 35542 110255317
Gastrointestinal bacterial overgrowth 40.10 16.02 24 298416 639 110290220
Hypogammaglobulinaemia 39.76 16.02 4 298436 20072 110270787
Eosinophil count increased 39.68 16.02 5 298435 21053 110269806
Paraesthesia 39.65 16.02 1002 297438 275519 110015340
Tooth disorder 39.60 16.02 15 298425 29494 110261365
Rash macular 39.56 16.02 28 298412 38658 110252201
Platelet count increased 39.55 16.02 11 298429 26323 110264536
Kidney infection 39.35 16.02 155 298285 25444 110265415
Haemolytic anaemia 39.34 16.02 5 298435 20915 110269944
Ataxia 39.26 16.02 16 298424 30092 110260767
Hot flush 39.19 16.02 74 298366 65962 110224897
Gingival bleeding 39.17 16.02 4 298436 19835 110271024
Movement disorder 39.04 16.02 25 298415 36379 110254480
Mania 39.04 16.02 5 298435 20791 110270068
Ventricular extrasystoles 38.94 16.02 7 298433 22634 110268225
Heart rate irregular 38.91 16.02 22 298418 34252 110256607
Anal stenosis 38.88 16.02 23 298417 599 110290260
Disease recurrence 38.88 16.02 65 298375 60719 110230140
Drug-induced liver injury 38.83 16.02 495 297945 119572 110171287
Eye pruritus 38.72 16.02 20 298420 32755 110258104
Glaucoma 38.64 16.02 7 298433 22510 110268349
Faeces discoloured 38.24 16.02 22 298418 33926 110256933
Mood altered 38.11 16.02 6 298434 21369 110269490
Flank pain 37.99 16.02 8 298432 23122 110267737
Adrenal insufficiency 37.96 16.02 35 298405 42355 110248504
Benign prostatic hyperplasia 37.82 16.02 3 298437 18231 110272628
Pyoderma gangrenosum 37.46 16.02 59 298381 5417 110285442
Cardiomyopathy 37.37 16.02 22 298418 33503 110257356
Muscle twitching 37.30 16.02 17 298423 29918 110260941
Klebsiella infection 37.10 16.02 5 298435 20004 110270855
Rhinitis allergic 37.03 16.02 3 298437 17919 110272940
Insomnia 37.00 16.02 1253 297187 359337 109931522
Mental impairment 36.84 16.02 8 298432 22631 110268228
Glomerular filtration rate decreased 36.77 16.02 16 298424 28940 110261919
Vaginal haemorrhage 36.69 16.02 11 298429 25063 110265796
Acute generalised exanthematous pustulosis 36.61 16.02 7 298433 21657 110269202
Polyuria 36.56 16.02 3 298437 17735 110273124
Mucous stools 36.51 16.02 66 298374 6781 110284078
Rib fracture 36.47 16.02 23 298417 33747 110257112
Sneezing 36.44 16.02 177 298263 31807 110259052
Dementia 36.43 16.02 20 298420 31653 110259206
Blood uric acid increased 36.29 16.02 7 298433 21522 110269337
Paraesthesia oral 36.27 16.02 23 298417 33648 110257211
Impaired work ability 36.18 16.02 13 298427 26406 110264453
Hepatitis cholestatic 36.13 16.02 3 298437 17563 110273296
Peripheral coldness 35.93 16.02 4 298436 18536 110272323
Muscular weakness 35.81 16.02 901 297539 247567 110043292
Overlap syndrome 35.79 16.02 77 298363 8982 110281877
Infusion site pain 35.76 16.02 3 298437 17416 110273443
Condition aggravated 35.58 16.02 2369 296071 732467 109558392
Blood albumin decreased 35.56 16.02 15 298425 27637 110263222
Cytomegalovirus infection reactivation 35.42 16.02 4 298436 18329 110272530
Mycobacterium tuberculosis complex test positive 35.33 16.02 44 298396 3244 110287615
Supraventricular tachycardia 35.22 16.02 11 298429 24411 110266448
Ear injury 35.10 16.02 18 298422 351 110290508
Flatulence 35.02 16.02 54 298386 52095 110238764
Chronic recurrent multifocal osteomyelitis 34.91 16.02 12 298428 79 110290780
Mental disorder 34.77 16.02 32 298408 38759 110252100
Wrong technique in product usage process 34.72 16.02 120 298320 87228 110203631
Parathyroid disorder 34.63 16.02 22 298418 653 110290206
Head injury 34.56 16.02 39 298401 42978 110247881
Injection site bruising 34.50 16.02 53 298387 51210 110239649
Urine output decreased 34.50 16.02 6 298434 19870 110270989
Pneumothorax 34.20 16.02 27 298413 35258 110255601
Device difficult to use 34.16 16.02 5 298435 18800 110272059
End stage renal disease 34.11 16.02 8 298432 21465 110269394
Limb discomfort 33.97 16.02 36 298404 40818 110250041
Pulmonary toxicity 33.96 16.02 4 298436 17742 110273117
Metastases to lung 33.96 16.02 10 298430 23053 110267806
Hyperthermia 33.64 16.02 8 298432 21264 110269595
Small intestinal stenosis 33.42 16.02 28 298412 1285 110289574
Pulmonary haemorrhage 33.33 16.02 3 298437 16453 110274406
Cardiovascular disorder 33.27 16.02 10 298430 22750 110268109
Respiratory tract congestion 33.20 16.02 168 298272 30689 110260170
Sinus disorder 33 16.02 175 298265 32553 110258306
Vasculitis 32.86 16.02 29 298411 35844 110255015
Decubitus ulcer 32.78 16.02 5 298435 18231 110272628
Apathy 32.78 16.02 3 298437 16236 110274623
Coordination abnormal 32.72 16.02 145 298295 25083 110265776
Anaphylactic reaction 32.62 16.02 178 298262 114122 110176737
Dermatitis atopic 32.62 16.02 14 298426 25527 110265332
Fracture 32.60 16.02 13 298427 24775 110266084
Food allergy 32.56 16.02 7 298433 19941 110270918
Diabetes mellitus inadequate control 32.54 16.02 20 298420 29755 110261104
General symptom 32.47 16.02 73 298367 8773 110282086
Hiatus hernia 32.39 16.02 17 298423 27589 110263270
Lung infiltration 32.26 16.02 13 298427 24615 110266244
Sudden death 31.75 16.02 13 298427 24382 110266477
Withdrawal syndrome 31.71 16.02 23 298417 31357 110259502
Lipase increased 31.62 16.02 6 298434 18666 110272193
Pulseless electrical activity 31.52 16.02 4 298436 16753 110274106
Hip fracture 31.50 16.02 29 298411 35122 110255737
Left ventricular dysfunction 31.43 16.02 12 298428 23481 110267378
Nervous system disorder 31.09 16.02 24 298416 31697 110259162
Subarachnoid haemorrhage 31.03 16.02 21 298419 29681 110261178
Musculoskeletal chest pain 30.67 16.02 20 298420 28827 110262032
Gout 30.65 16.02 32 298408 36534 110254325
Ecchymosis 30.61 16.02 5 298435 17333 110273526
Concomitant disease aggravated 30.56 16.02 4 298436 16360 110274499
Facial pain 30.52 16.02 3 298437 15336 110275523
Unevaluable event 30.43 16.02 72 298368 59155 110231704
Ischaemic stroke 30.41 16.02 40 298400 41223 110249636
Eyelid oedema 30.33 16.02 3 298437 15259 110275600
Hidradenitis 30.29 16.02 52 298388 5128 110285731
Conjunctivitis 30.14 16.02 28 298412 33764 110257095
Feeding disorder 30.13 16.02 10 298430 21352 110269507
Liver function test abnormal 30.00 16.02 91 298349 68859 110222000
Toothache 29.98 16.02 13 298427 23562 110267297
Chest discomfort 29.92 16.02 312 298128 173536 110117323
Crying 29.74 16.02 16 298424 25612 110265247
Confusional state 29.71 16.02 1548 296892 467132 109823727
Infected fistula 29.65 16.02 18 298422 492 110290367
Lacrimation increased 29.60 16.02 24 298416 30926 110259933
Therapy partial responder 29.34 16.02 34 298406 37027 110253832
Injection site mass 29.11 16.02 15 298425 24598 110266261
Blood pressure abnormal 29.10 16.02 12 298428 22412 110268447
Dermatitis bullous 28.92 16.02 6 298434 17523 110273336
Hyperthyroidism 28.86 16.02 22 298418 29239 110261620
Manufacturing product shipping issue 28.84 16.02 11 298429 101 110290758
Aspiration 28.80 16.02 24 298416 30509 110260350
Plasmablastic lymphoma 28.70 16.02 21 298419 789 110290070
Pneumonia lipoid 28.66 16.02 13 298427 191 110290668
Oral candidiasis 28.50 16.02 48 298392 44712 110246147
COVID-19 pneumonia 28.42 16.02 35 298405 37108 110253751
Intervertebral disc degeneration 28.21 16.02 7 298433 18078 110272781
Transient ischaemic attack 28.15 16.02 84 298356 63898 110226961
Postoperative wound infection 28.06 16.02 100 298340 15653 110275206
Acute myeloid leukaemia 28.03 16.02 37 298403 38073 110252786
Incorrect route of product administration 27.92 16.02 280 298160 63781 110227078
Myocarditis 27.89 16.02 24 298416 30031 110260828
Urosepsis 27.85 16.02 25 298415 30650 110260209
Rash vesicular 27.82 16.02 95 298345 14557 110276302
Emotional disorder 27.78 16.02 5 298435 16155 110274704
Oedema peripheral 27.70 16.02 675 297765 327985 109962874
Hypoaesthesia oral 27.68 16.02 6 298434 16996 110273863
Injection site swelling 27.28 16.02 81 298359 61709 110229150
Chikungunya virus infection 27.22 16.02 13 298427 216 110290643
Blood magnesium decreased 27.11 16.02 10 298430 19986 110270873
Respiratory symptom 27.09 16.02 4 298436 14941 110275918
Sleep apnoea syndrome 27.05 16.02 42 298398 40405 110250454
Delirium 26.90 16.02 513 297927 134512 110156347
Venous injury 26.90 16.02 22 298418 976 110289883
Blood urine present 26.90 16.02 16 298424 24229 110266630
Gingival pain 26.77 16.02 5 298435 15731 110275128
Cold sweat 26.69 16.02 13 298427 22018 110268841
Muscle tightness 26.65 16.02 4 298436 14758 110276101
Pneumonia fungal 26.63 16.02 4 298436 14750 110276109
Feeling jittery 26.55 16.02 4 298436 14718 110276141
Haemolysis 26.54 16.02 5 298435 15634 110275225
Cholangitis sclerosing 26.48 16.02 40 298400 3542 110287317
Immunodeficiency 26.29 16.02 40 298400 38798 110252061
Blood calcium increased 26.24 16.02 8 298432 18032 110272827
Injection site urticaria 26.21 16.02 7 298433 17208 110273651
Drug level below therapeutic 26.07 16.02 80 298360 11593 110279266
Dermatitis allergic 26.05 16.02 13 298427 21711 110269148
Nephropathy 25.86 16.02 3 298437 13464 110277395
Posterior reversible encephalopathy syndrome 25.81 16.02 32 298408 33829 110257030
Blood pressure systolic decreased 25.80 16.02 3 298437 13438 110277421
Acute pulmonary oedema 25.71 16.02 7 298433 16989 110273870
Micturition urgency 25.63 16.02 10 298430 19310 110271549
Myasthenia gravis 25.60 16.02 13 298427 21498 110269361
Impaired gastric emptying 25.39 16.02 3 298437 13272 110277587
Poor quality sleep 25.35 16.02 23 298417 28054 110262805
Atrioventricular block first degree 25.34 16.02 4 298436 14221 110276638
Hydronephrosis 25.34 16.02 12 298428 20653 110270206
Apoptotic colonopathy 25.26 16.02 12 298428 197 110290662
Injection site rash 25.22 16.02 16 298424 23403 110267456
Exposure via skin contact 25.07 16.02 3 298437 13144 110277715
Upper-airway cough syndrome 25.01 16.02 6 298434 15851 110275008
Sleep disorder due to general medical condition, hypersomnia type 24.94 16.02 29 298411 1990 110288869
Drug specific antibody present 24.93 16.02 64 298376 8370 110282489
Temperature intolerance 24.68 16.02 4 298436 13946 110276913
Pain 24.66 16.02 2940 295500 952015 109338844
Faecal calprotectin abnormal 24.54 16.02 14 298426 340 110290519
Rash papular 24.53 16.02 23 298417 27616 110263243
Neurological symptom 24.43 16.02 6 298434 15602 110275257
Tenderness 24.41 16.02 26 298414 29411 110261448
Eye swelling 24.39 16.02 32 298408 33016 110257843
Tuberculin test positive 24.38 16.02 39 298401 3629 110287230
Cardiac failure chronic 24.35 16.02 4 298436 13807 110277052
Glycosylated haemoglobin increased 24.28 16.02 17 298423 23602 110267257
Pulmonary alveolar haemorrhage 24.25 16.02 12 298428 20138 110270721
Product packaging quantity issue 24.18 16.02 27 298413 1772 110289087
Osteopenia 24.16 16.02 15 298425 22194 110268665
Radiculopathy 24.06 16.02 11 298429 19325 110271534
Lichen myxoedematosus 24.05 16.02 8 298432 47 110290812
Deafness 23.98 16.02 22 298418 26687 110264172
Arteriosclerosis 23.94 16.02 19 298421 24748 110266111
Hyperuricaemia 23.92 16.02 5 298435 14526 110276333
Intestinal ischaemia 23.85 16.02 7 298433 16172 110274687
Iron deficiency 23.80 16.02 10 298430 18466 110272393
Colitis 23.69 16.02 170 298270 102153 110188706
Osteonecrosis 23.57 16.02 34 298406 33707 110257152
Spinal fusion surgery 23.56 16.02 66 298374 9090 110281769
Brain injury 23.54 16.02 4 298436 13472 110277387
Injection related reaction 23.51 16.02 25 298415 1553 110289306
Guttate psoriasis 23.50 16.02 16 298424 535 110290324
Poor venous access 23.47 16.02 19 298421 24503 110266356
Eye disorder 23.45 16.02 26 298414 28880 110261979
Hospice care 23.41 16.02 3 298437 12470 110278389
Acute coronary syndrome 23.28 16.02 17 298423 23095 110267764
Transaminases increased 23.28 16.02 90 298350 63300 110227559
Gastric haemorrhage 23.25 16.02 7 298433 15908 110274951
Organising pneumonia 23.24 16.02 5 298435 14238 110276621
Ageusia 23.19 16.02 12 298428 19633 110271226
Asphyxia 23.18 16.02 5 298435 14210 110276649
Eye injury 23.08 16.02 59 298381 7696 110283163
Angiolymphoid hyperplasia with eosinophilia 23.07 16.02 10 298430 131 110290728
Skin necrosis 23.05 16.02 117 298323 21395 110269464
Duodenal ulcer 22.92 16.02 12 298428 19502 110271357
Nasal polyps 22.88 16.02 4 298436 13196 110277663
Hepatitis acute 22.85 16.02 11 298429 18755 110272104
Parosmia 22.83 16.02 4 298436 13176 110277683
Faecaloma 22.82 16.02 6 298434 14902 110275957
Eructation 22.80 16.02 5 298435 14052 110276807
Renal injury 22.74 16.02 11 298429 18702 110272157
Systemic inflammatory response syndrome 22.50 16.02 4 298436 13039 110277820
Limb injury 22.48 16.02 42 298398 37594 110253265
Product label issue 22.45 16.02 20 298420 998 110289861
Spinal fracture 22.34 16.02 17 298423 22616 110268243
Blood triglycerides increased 22.33 16.02 19 298421 23907 110266952
Pathological fracture 22.33 16.02 3 298437 12029 110278830
Respiratory acidosis 22.26 16.02 5 298435 13821 110277038
Eating disorder 22.15 16.02 151 298289 30707 110260152
Tooth abscess 22.14 16.02 105 298335 18684 110272175
Spinal compression fracture 22.06 16.02 11 298429 18381 110272478
Dermatologic examination abnormal 22.03 16.02 6 298434 15 110290844
Hypertensive crisis 21.97 16.02 20 298420 24352 110266507
Erythema multiforme 21.93 16.02 15 298425 21082 110269777
Seasonal allergy 21.90 16.02 13 298427 19709 110271150
Abnormal dreams 21.87 16.02 4 298436 12776 110278083
Viral infection 21.80 16.02 72 298368 53067 110237792
Eye haemorrhage 21.70 16.02 3 298437 11771 110279088
Skin laceration 21.67 16.02 36 298404 33717 110257142
Thinking abnormal 21.51 16.02 7 298433 15133 110275726
Rheumatoid nodule 21.48 16.02 110 298330 20186 110270673
Parkinsonism 21.47 16.02 17 298423 22170 110268689
Mood swings 21.43 16.02 18 298422 22794 110268065
Drug ineffective for unapproved indication 21.39 16.02 176 298264 102662 110188197
Normal newborn 21.34 16.02 116 298324 21780 110269079
Gastrointestinal anastomotic stenosis 21.21 16.02 8 298432 71 110290788
Coronary artery occlusion 21.19 16.02 8 298432 15764 110275095
Emotional distress 21.11 16.02 57 298383 44790 110246069
Vaginal discharge 21.05 16.02 11 298429 17897 110272962
Infusion site reaction 20.98 16.02 99 298341 17583 110273276
Left ventricular hypertrophy 20.91 16.02 5 298435 13239 110277620
Multiple-drug resistance 20.89 16.02 5 298435 13230 110277629
Pneumonia bacterial 20.89 16.02 24 298416 26237 110264622
Cervical dysplasia 20.83 16.02 31 298409 2709 110288150
Immune thrombocytopenia 20.83 16.02 18 298422 22476 110268383
Left ventricular failure 20.76 16.02 3 298437 11386 110279473
Proctocolectomy 20.72 16.02 11 298429 231 110290628
Partial seizures 20.66 16.02 3 298437 11346 110279513
Cardiac tamponade 20.56 16.02 3 298437 11304 110279555
Intestinal anastomosis complication 20.34 16.02 13 298427 390 110290469
Joint effusion 20.26 16.02 16 298424 20889 110269970
Coronary artery stenosis 20.19 16.02 6 298434 13752 110277107
Spinal osteoarthritis 20.13 16.02 15 298425 20168 110270691
Dolichocolon 20.12 16.02 7 298433 48 110290811
Small intestine operation 20.12 16.02 7 298433 48 110290811
Gastrointestinal infection 20.09 16.02 83 298357 13922 110276937
Bundle branch block left 20.08 16.02 5 298435 12883 110277976
Cutaneous sporotrichosis 20.03 16.02 8 298432 84 110290775
Infusion site erythema 19.92 16.02 4 298436 11955 110278904
Gastric disorder 19.80 16.02 156 298284 33201 110257658
Failure to thrive 19.78 16.02 6 298434 13568 110277291
Aortic valve incompetence 19.76 16.02 3 298437 10978 110279881
Photosensitivity reaction 19.69 16.02 24 298416 25565 110265294
Breast cancer 19.55 16.02 174 298266 38368 110252491
Erectile dysfunction 19.55 16.02 13 298427 18543 110272316
Protein total decreased 19.54 16.02 3 298437 10887 110279972
Therapy cessation 19.51 16.02 196 298244 44661 110246198
Muscle swelling 19.46 16.02 19 298421 1066 110289793
Panic attack 19.40 16.02 30 298410 28910 110261949
Injection site reaction 19.34 16.02 343 298097 88727 110202132
Pelvic fracture 19.32 16.02 7 298433 14147 110276712
Heavy menstrual bleeding 19.31 16.02 10 298430 16355 110274504
Dermatitis psoriasiform 19.27 16.02 35 298405 3609 110287250
Humerus fracture 19.27 16.02 3 298437 10773 110280086
Fistula discharge 19.26 16.02 23 298417 1623 110289236
Intestinal ulcer 19.23 16.02 28 298412 2399 110288460
Eyelid ptosis 19.22 16.02 6 298434 13321 110277538
Embolism 19.15 16.02 10 298430 16279 110274580
Monocyte count increased 19.15 16.02 6 298434 13287 110277572
Head discomfort 19.10 16.02 14 298426 18986 110271873
Genital cyst 19.09 16.02 7 298433 57 110290802
Large intestine anastomosis 18.93 16.02 8 298432 98 110290761
Malignant melanoma 18.90 16.02 93 298347 16798 110274061
Hepatomegaly 18.80 16.02 18 298422 21396 110269463
Staphylococcal sepsis 18.70 16.02 12 298428 17442 110273417
Defaecation urgency 18.66 16.02 59 298381 8688 110282171
Foetal death 18.65 16.02 10 298430 16035 110274824
Bone density decreased 18.64 16.02 10 298430 16032 110274827
Anaplastic large-cell lymphoma 18.62 16.02 10 298430 215 110290644
Necrosis 18.62 16.02 4 298436 11402 110279457
Injection site warmth 18.60 16.02 12 298428 17393 110273466
Epstein-Barr virus infection 18.59 16.02 14 298426 18724 110272135
Injection site induration 18.57 16.02 4 298436 11379 110279480
Vitamin D decreased 18.54 16.02 5 298435 12210 110278649
Peripheral sensory neuropathy 18.52 16.02 11 298429 16669 110274190
Adenocarcinoma of colon 18.43 16.02 47 298393 6121 110284738
Pelvic pain 18.43 16.02 10 298430 15932 110274927
Respiratory syncytial virus infection 18.40 16.02 8 298432 14476 110276383
Bone disorder 18.38 16.02 18 298422 21174 110269685
Cerebral ischaemia 18.28 16.02 5 298435 12099 110278760
Subcutaneous abscess 18.21 16.02 61 298379 9256 110281603
Injection site papule 18.20 16.02 18 298422 1026 110289833
Musculoskeletal discomfort 18.20 16.02 22 298418 23516 110267343
Thirst 18.19 16.02 19 298421 21688 110269171
Dyschezia 18.18 16.02 35 298405 3772 110287087
Breast cancer metastatic 18.09 16.02 4 298436 11177 110279682
Hallucination, auditory 18.05 16.02 27 298413 26370 110264489
Hypersomnia 17.95 16.02 30 298410 28031 110262828
Periumbilical abscess 17.92 16.02 11 298429 307 110290552
Increased appetite 17.90 16.02 9 298431 14968 110275891
Lymphoedema 17.80 16.02 9 298431 14920 110275939
Pathogen resistance 17.80 16.02 13 298427 17659 110273200
Paralysis 17.73 16.02 10 298430 15590 110275269
Gastric ulcer haemorrhage 17.62 16.02 3 298437 10091 110280768
Ketoacidosis 17.61 16.02 3 298437 10084 110280775
Femoral neck fracture 17.52 16.02 6 298434 12561 110278298
Sensitivity to weather change 17.46 16.02 3 298437 10025 110280834
Amylase increased 17.42 16.02 6 298434 12513 110278346
Carbon dioxide abnormal 17.39 16.02 14 298426 607 110290252
Product substitution issue 17.36 16.02 22 298418 23039 110267820
Ligament sprain 17.28 16.02 11 298429 16057 110274802
Lung opacity 17.25 16.02 5 298435 11647 110279212
Stoma site abscess 17.24 16.02 11 298429 329 110290530
Fear of injection 17.11 16.02 58 298382 8853 110282006
Pulmonary thrombosis 17.07 16.02 8 298432 13855 110277004
Nephrotic syndrome 17.01 16.02 8 298432 13823 110277036
Drug dose omission by device 16.94 16.02 9 298431 14507 110276352
Diffuse large B-cell lymphoma 16.93 16.02 11 298429 15887 110274972
Aortic stenosis 16.93 16.02 7 298433 13052 110277807
Ileocolostomy 16.90 16.02 6 298434 44 110290815
Herpes zoster 16.86 16.02 199 298241 108180 110182679
Sporotrichosis 16.86 16.02 8 298432 131 110290728
Multiple allergies 16.85 16.02 6 298434 12257 110278602
Pneumoretroperitoneum 16.78 16.02 9 298431 193 110290666
Eye movement disorder 16.75 16.02 3 298437 9725 110281134
Pityriasis rubra pilaris 16.68 16.02 10 298430 267 110290592
Stoma creation 16.66 16.02 9 298431 196 110290663
Dermatitis exfoliative generalised 16.52 16.02 66 298374 10906 110279953
Bacterial vulvovaginitis 16.50 16.02 14 298426 654 110290205
Device ineffective 16.41 16.02 9 298431 202 110290657
Carotid artery occlusion 16.36 16.02 3 298437 9562 110281297
Hypokinesia 16.25 16.02 21 298419 21805 110269054
Malignant melanoma in situ 16.23 16.02 32 298408 3510 110287349
Alcoholic liver disease 16.22 16.02 13 298427 560 110290299
Post procedural haemorrhage 16.16 16.02 11 298429 15501 110275358
Rotator cuff syndrome 16.09 16.02 13 298427 16781 110274078
Drug specific antibody 16.03 16.02 28 298412 2800 110288059

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AC05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
MeSH PA D003879 Dermatologic Agents
FDA MoA N0000192796 Interleukin-12 Antagonists
FDA EPC N0000192797 Interleukin-12 Antagonist
FDA MoA N0000192798 Interleukin-23 Antagonists
FDA EPC N0000192799 Interleukin-23 Antagonist
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50177 dermatologic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:66981 ophthalmology drug
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

L04AC Interleukin inhibitors 18 drugs

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

DiseaseRelationSNOMED_IDDOID
Psoriasis indication 9014002 DOID:8893
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Ulcerative colitis indication 64766004 DOID:8577
Plaque psoriasis indication 200965009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Interleukin-12 Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL
Interleukin-23 Cytokine ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D09214 KEGG_DRUG
4029348 VUID
N0000180304 NUI
4029348 VANDF
CHEBI:749609 CHEBI
CHEMBL1201835 ChEMBL_ID
6885 IUPHAR_LIGAND_ID
DB05679 DRUGBANK_ID
847083 RXNORM
160966 MMSL
26198 MMSL
393314 MMSL
d07396 MMSL
013009 NDDF
443465002 SNOMEDCT_US
443644001 SNOMEDCT_US
C1608841 UMLSCUI
D000069549 MESH_DESCRIPTOR_UI
8954 INN_ID
FU77B4U5Z0 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Starjemza HUMAN PRESCRIPTION DRUG LABEL 1 0143-9168 INJECTION 45 mg SUBCUTANEOUS BLA 27 sections
Starjemza HUMAN PRESCRIPTION DRUG LABEL 1 0143-9169 INJECTION 45 mg SUBCUTANEOUS BLA 27 sections
Starjemza HUMAN PRESCRIPTION DRUG LABEL 1 0143-9170 INJECTION 90 mg SUBCUTANEOUS BLA 27 sections
Starjemza HUMAN PRESCRIPTION DRUG LABEL 1 0143-9171 INJECTION 130 mg INTRAVENOUS BLA 27 sections
SELARSDI HUMAN PRESCRIPTION DRUG LABEL 1 50090-7769 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections
Ustekinumab-aekn HUMAN PRESCRIPTION DRUG LABEL 1 51759-413 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
Ustekinumab-aekn HUMAN PRESCRIPTION DRUG LABEL 1 51759-414 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections
Selarsdi HUMAN PRESCRIPTION DRUG LABEL 1 51759-505 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
Selarsdi HUMAN PRESCRIPTION DRUG LABEL 1 51759-607 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections
Selarsdi HUMAN PRESCRIPTION DRUG LABEL 1 51759-708 INJECTION, SOLUTION 130 mg INTRAVENOUS BLA 30 sections
Ustekinumab-aekn HUMAN PRESCRIPTION DRUG LABEL 1 51759-709 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
Ustekinumab-aekn HUMAN PRESCRIPTION DRUG LABEL 1 51759-710 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections
Stelara HUMAN PRESCRIPTION DRUG LABEL 1 57894-054 SOLUTION 130 mg INTRAVENOUS BLA 34 sections
Stelara HUMAN PRESCRIPTION DRUG LABEL 1 57894-054 SOLUTION 130 mg INTRAVENOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-060 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-060 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-061 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 34 sections
STELARA HUMAN PRESCRIPTION DRUG LABEL 1 57894-061 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 34 sections
ustekinumab HUMAN PRESCRIPTION DRUG LABEL 1 57894-440 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 32 sections
ustekinumab HUMAN PRESCRIPTION DRUG LABEL 1 57894-441 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 32 sections
ustekinumab HUMAN PRESCRIPTION DRUG LABEL 1 57894-444 SOLUTION 130 mg INTRAVENOUS BLA 32 sections
PYZCHIVA HUMAN PRESCRIPTION DRUG LABEL 1 61314-651 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 27 sections
PYZCHIVA HUMAN PRESCRIPTION DRUG LABEL 1 61314-652 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 27 sections
PYZCHIVA HUMAN PRESCRIPTION DRUG LABEL 1 61314-654 INJECTION, SOLUTION 130 mg INTRAVENOUS BLA 27 sections
Otulfi HUMAN PRESCRIPTION DRUG LABEL 1 65219-822 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
Otulfi HUMAN PRESCRIPTION DRUG LABEL 1 65219-824 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
Otulfi HUMAN PRESCRIPTION DRUG LABEL 1 65219-826 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections
Otulfi HUMAN PRESCRIPTION DRUG LABEL 1 65219-828 SOLUTION 130 mg INTRAVENOUS BLA 30 sections
USTEKINUMAB-AAUZ HUMAN PRESCRIPTION DRUG LABEL 1 65219-862 INJECTION, SOLUTION 45 mg SUBCUTANEOUS BLA 30 sections
USTEKINUMAB-AAUZ HUMAN PRESCRIPTION DRUG LABEL 1 65219-866 INJECTION, SOLUTION 90 mg SUBCUTANEOUS BLA 30 sections