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

Stem definitionDrug idCAS RN
humanized origin 4968 428863-50-7

Description:

MoleculeDescription

Synonyms:

  • certolizumab pegol
  • cimzia
  • certolizumab
A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
14 mg P

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
April 22, 2008 FDA UCB INC
Oct. 1, 2009 EMA
Dec. 25, 2012 PMDA UCB Japan Co., Ltd.

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
Pemphigus 3115.94 17.98 6242 518715 320622 89782868
Systemic lupus erythematosus 2919.44 17.98 6455 518502 355441 89748049
Glossodynia 2765.27 17.98 5889 519068 315890 89787600
Maternal exposure during pregnancy 2663.21 17.98 6206 518751 353857 89749633
Contraindicated product administered 2620.22 17.98 5745 519212 314394 89789096
Hand deformity 2386.82 17.98 5285 519672 291077 89812413
Drug ineffective 2364.57 17.98 14849 510108 1369449 88734041
Alopecia 2155.33 17.98 7027 517930 488044 89615446
Swelling 2152.27 17.98 6302 518655 412756 89690734
Arthropathy 2096.40 17.98 5729 519228 360513 89742977
Synovitis 2004.49 17.98 5275 519682 324477 89779013
Abdominal discomfort 1929.38 17.98 6609 518348 470719 89632771
Wound 1893.59 17.98 4898 520059 298082 89805408
Anti-cyclic citrullinated peptide antibody positive 1835.62 17.98 4157 520800 232276 89871214
Joint swelling 1710.45 17.98 6587 518370 496713 89606777
Therapeutic product effect decreased 1634.79 17.98 4390 520567 273181 89830309
Pericarditis 1615.55 17.98 4297 520660 265854 89837636
Drug intolerance 1606.28 17.98 5962 518995 441629 89661861
Acute kidney injury 1546.42 17.98 74 524883 320313 89783177
Anaemia 1469.24 17.98 164 524793 352638 89750852
Drug interaction 1466.46 17.98 27 524930 276426 89827064
Toxicity to various agents 1444.47 17.98 50 524907 287796 89815694
Hypersensitivity 1399.27 17.98 5771 519186 448906 89654584
Discomfort 1374.59 17.98 4093 520864 270242 89833248
Folliculitis 1336.85 17.98 3363 521594 200990 89902500
Helicobacter infection 1292.03 17.98 3545 521412 223305 89880185
Maternal exposure before pregnancy 1279.28 17.98 802 524155 10411 90093079
Duodenal ulcer perforation 1273.13 17.98 3471 521486 217817 89885673
Hypotension 1221.07 17.98 208 524749 325189 89778301
Irritable bowel syndrome 1214.39 17.98 3275 521682 204173 89899317
Muscle injury 1210.96 17.98 2960 521997 173694 89929796
Pain 1124.36 17.98 9703 515254 986638 89116852
Blister 1103.80 17.98 3617 521340 251381 89852109
Impaired healing 1093.77 17.98 3410 521547 230789 89872701
Rheumatoid factor positive 1083.98 17.98 2788 522169 168862 89934628
Treatment failure 1071.32 17.98 4028 520929 299900 89803590
Constipation 1059.05 17.98 176 524781 280219 89823271
Lower respiratory tract infection 1045.24 17.98 3511 521446 247148 89856342
Hepatic enzyme increased 1043.36 17.98 4495 520462 356241 89747249
Death 1003.15 17.98 711 524246 455840 89647650
Product availability issue 992.03 17.98 587 524370 6817 90096673
Ill-defined disorder 987.06 17.98 2823 522134 182068 89921422
Fall 978.85 17.98 813 524144 480997 89622493
Sleep disorder due to general medical condition, insomnia type 951.25 17.98 2221 522736 126473 89977017
Therapy interrupted 946.44 17.98 1304 523653 48804 90054686
Neutropenia 907.52 17.98 116 524841 224788 89878702
Febrile neutropenia 862.82 17.98 10 524947 158339 89945151
Psoriatic arthropathy 809.63 17.98 3033 521924 225302 89878188
Cough 801.75 17.98 581 524376 368381 89735109
Infusion related reaction 794.14 17.98 4615 520342 412165 89691325
Rheumatoid arthritis 792.85 17.98 4168 520789 358446 89745044
Infection 779.33 17.98 4144 520813 357950 89745540
Rash 764.80 17.98 7495 517462 788605 89314885
Rheumatic fever 740.74 17.98 2258 522699 150863 89952627
Thrombocytopenia 732.59 17.98 157 524800 208568 89894922
Product use issue 729.87 17.98 3805 521152 326114 89777376
Stomatitis 707.04 17.98 3308 521649 271390 89832100
Dehydration 699.52 17.98 138 524819 194309 89909181
Disease progression 690.37 17.98 58 524899 156557 89946933
Hyponatraemia 680.94 17.98 20 524937 133518 89969972
Maternal exposure during breast feeding 659.98 17.98 425 524532 5795 90097695
Seizure 637.20 17.98 70 524887 152559 89950931
Sinusitis 624.64 17.98 3755 521202 339333 89764157
Nausea 621.68 17.98 3832 521125 1106484 88997006
Somnolence 620.22 17.98 218 524739 208866 89894624
Tremor 610.58 17.98 82 524875 153091 89950399
Gastrointestinal disorder 604.10 17.98 3013 521944 253674 89849816
Haemoglobin decreased 603.84 17.98 105 524852 161851 89941639
Type 2 diabetes mellitus 600.73 17.98 2551 522406 200693 89902797
Pancytopenia 579.05 17.98 28 524929 120235 89983255
Swollen joint count increased 571.81 17.98 1676 523281 109530 89993960
Insurance issue 558.81 17.98 482 524475 10476 90093014
Renal failure 544.53 17.98 61 524896 130946 89972544
Musculoskeletal stiffness 544.35 17.98 3253 521704 293279 89810211
Oxygen saturation decreased 530.75 17.98 21 524936 107462 89996028
Sepsis 520.52 17.98 195 524762 179619 89923871
Intentional overdose 520.16 17.98 4 524953 93830 90009660
Cardiac arrest 509.84 17.98 23 524934 104912 89998578
Pulmonary embolism 505.14 17.98 77 524880 130743 89972747
Blood cholesterol increased 501.56 17.98 2459 522498 205553 89897937
White blood cell count decreased 499.40 17.98 172 524785 166937 89936553
Peripheral swelling 499.15 17.98 4092 520865 409014 89694476
Platelet count decreased 495.10 17.98 96 524861 136873 89966617
Liver injury 494.74 17.98 2129 522828 168438 89935052
Neuropathy peripheral 492.99 17.98 97 524860 136873 89966617
Respiratory failure 492.52 17.98 55 524902 118363 89985127
Mobility decreased 471.85 17.98 2769 522188 247965 89855525
Myalgia 463.36 17.98 217 524740 174908 89928582
Nasopharyngitis 460.17 17.98 3973 520984 403131 89700359
Drug abuse 454.08 17.98 4 524953 82343 90021147
Chest discomfort 450.25 17.98 122 524835 138243 89965247
Renal impairment 448.59 17.98 45 524912 105376 89998114
Cardiac failure 437.83 17.98 58 524899 109438 89994052
Fibromyalgia 436.39 17.98 2351 522606 203918 89899572
Arthralgia 424.07 17.98 6591 518366 771931 89331559
Dysphagia 422.43 17.98 71 524886 112207 89991283
Bradycardia 411.90 17.98 17 524940 83830 90019660
Hip arthroplasty 411.41 17.98 1169 523788 75039 90028451
Cerebrovascular accident 405.58 17.98 107 524850 123426 89980064
C-reactive protein abnormal 404.19 17.98 1635 523322 125794 89977696
Syncope 399.04 17.98 135 524822 132528 89970962
Gastrointestinal haemorrhage 396.07 17.98 34 524923 90214 90013276
Cardiac failure congestive 395.27 17.98 52 524905 98642 90004848
Blood pressure increased 393.36 17.98 338 524619 196879 89906611
Depressed level of consciousness 390.25 17.98 6 524951 72778 90030712
Hyperhidrosis 389.14 17.98 151 524806 136154 89967336
Electrocardiogram QT prolonged 388.37 17.98 6 524951 72450 90031040
Neutrophil count decreased 387.42 17.98 5 524952 71527 90031963
Blood iron abnormal 378.66 17.98 255 524702 3765 90099725
Balance disorder 375.10 17.98 57 524900 97023 90006467
Suicide attempt 371.34 17.98 15 524942 75384 90028106
Hypokalaemia 366.53 17.98 150 524807 130966 89972524
Coma 362.67 17.98 13 524944 72619 90030871
Heart rate increased 359.04 17.98 104 524853 112798 89990692
Hyperkalaemia 358.94 17.98 3 524954 64961 90038529
Injury 354.79 17.98 2154 522803 195195 89908295
Knee arthroplasty 354.73 17.98 1175 523782 82007 90021483
Hypoxia 354.56 17.98 15 524942 72384 90031106
Palpitations 348.63 17.98 178 524779 136550 89966940
Cardio-respiratory arrest 348.45 17.98 3 524954 63137 90040353
Overdose 346.51 17.98 245 524712 157464 89946026
Hypoglycaemia 343.64 17.98 14 524943 69834 90033656
Flushing 341.79 17.98 52 524905 88439 90015051
General physical health deterioration 336.11 17.98 3337 521620 351778 89751712
Deep vein thrombosis 335.79 17.98 62 524895 91558 90011932
Hallucination 332.17 17.98 11 524946 65948 90037542
Chills 330.32 17.98 176 524781 131805 89971685
Feeling abnormal 326.97 17.98 292 524665 166943 89936547
Dyspnoea 326.80 17.98 3396 521561 877559 89225931
Agitation 324.97 17.98 15 524942 67083 90036407
Facet joint syndrome 324.47 17.98 1278 523679 97111 90006379
COVID-19 immunisation 323.40 17.98 172 524785 1597 90101893
Cognitive disorder 322.16 17.98 20 524937 69387 90034103
Blood creatinine increased 321.28 17.98 94 524863 101292 90002198
Diarrhoea 320.72 17.98 3690 521267 935500 89167990
Multiple organ dysfunction syndrome 316.26 17.98 20 524937 68316 90035174
Night sweats 315.72 17.98 1530 523427 127236 89976254
Vision blurred 308.56 17.98 126 524831 110167 89993323
Dyspnoea exertional 307.17 17.98 31 524926 72257 90031233
Grip strength decreased 305.68 17.98 1203 523754 91373 90012117
Epistaxis 296.55 17.98 65 524892 85060 90018430
Blood pressure decreased 296.25 17.98 41 524916 74854 90028636
Adverse event 295.70 17.98 1406 523551 116012 89987478
Mucosal inflammation 292.37 17.98 9 524948 57616 90045874
Hypercholesterolaemia 290.56 17.98 1257 523700 99635 90003855
Weight decreased 288.71 17.98 1176 523781 378734 89724756
Tachycardia 286.43 17.98 294 524663 157379 89946111
Suicidal ideation 286.15 17.98 43 524914 73812 90029678
Intentional dose omission 284.72 17.98 428 524529 17355 90086135
Pulmonary oedema 281.92 17.98 20 524937 62060 90041430
Urinary tract infection 270.41 17.98 888 524069 304744 89798746
Contusion 269.55 17.98 2425 522532 248791 89854699
Joint range of motion decreased 267.93 17.98 1518 523439 134125 89969365
Metabolic acidosis 267.84 17.98 13 524944 55663 90047827
Rhabdomyolysis 263.74 17.98 7 524950 51249 90052241
Lip dry 263.06 17.98 1221 523736 99734 90003756
Lethargy 260.81 17.98 30 524927 63109 90040381
Hyperglycaemia 254.90 17.98 9 524948 50961 90052529
Atrial fibrillation 252.03 17.98 241 524716 133370 89970120
Blood glucose increased 251.89 17.98 118 524839 95128 90008362
Pleural effusion 249.92 17.98 171 524786 111820 89991670
International normalised ratio increased 249.12 17.98 5 524952 47311 90056179
Angioedema 248.54 17.98 39 524918 64837 90038653
Urticaria 245.47 17.98 2831 522126 309903 89793587
Erythema 242.31 17.98 612 524345 228634 89874856
Productive cough 241.33 17.98 73 524884 76990 90026500
Heart rate decreased 240.78 17.98 18 524939 53487 90050003
Chronic kidney disease 240.55 17.98 12 524945 50179 90053311
Neoplasm progression 237.08 17.98 4 524953 44482 90059008
Encephalopathy 232.97 17.98 8 524949 46436 90057054
Pregnancy 232.75 17.98 840 524117 61207 90042283
Dysphonia 232.65 17.98 42 524915 63042 90040448
Dysarthria 232.43 17.98 23 524934 54459 90049031
Loss of personal independence in daily activities 231.58 17.98 1465 523492 134640 89968850
Sleep disorder 231.33 17.98 1948 523009 196082 89907408
Dizziness 229.88 17.98 2243 522714 587041 89516449
Pulmonary fibrosis 227.60 17.98 1226 523731 106277 89997213
Blood bilirubin increased 227.26 17.98 5 524952 43465 90060025
Ascites 226.95 17.98 12 524945 47728 90055762
Deep vein thrombosis postoperative 226.38 17.98 911 524046 69898 90033592
Bone pain 222.76 17.98 44 524913 61939 90041551
Pulmonary hypertension 221.88 17.98 5 524952 42518 90060972
Bone erosion 220.71 17.98 743 524214 52278 90051212
Intentional product use issue 220.13 17.98 2069 522888 214823 89888667
Foot deformity 218.20 17.98 801 524156 58850 90044640
Leukopenia 216.55 17.98 160 524797 100550 90002940
Rhinorrhoea 216.27 17.98 121 524836 88195 90015295
No adverse event 215.24 17.98 872 524085 67110 90036380
Myelosuppression 215.14 17.98 28 524929 53563 90049927
Inflammation 215.09 17.98 1769 523188 176823 89926667
Product dose omission issue 214.53 17.98 2608 522349 289079 89814411
Back pain 210.62 17.98 1032 523925 316143 89787347
Osteonecrosis of jaw 210.58 17.98 3 524954 39100 90064390
Plasma cell myeloma 208.50 17.98 6 524951 40822 90062668
Disorientation 206.88 17.98 12 524945 44102 90059388
Hepatic failure 206.02 17.98 5 524952 39723 90063767
Injection site discolouration 205.89 17.98 262 524695 9058 90094432
Autoimmune disorder 205.70 17.98 936 524021 75808 90027682
Gait inability 205.38 17.98 1503 523454 144953 89958537
Breast cancer stage III 203.77 17.98 999 523958 83448 90020042
Acute respiratory failure 203.36 17.98 11 524946 42907 90060583
Unresponsive to stimuli 200.81 17.98 4 524953 38117 90065373
Wrong technique in product usage process 199.79 17.98 82 524875 71489 90032001
Dry skin 198.49 17.98 133 524824 87940 90015550
Vomiting 197.32 17.98 3296 521661 784997 89318493
Confusional state 195.93 17.98 3234 521723 382971 89720519
Dyskinesia 195.89 17.98 3 524954 36531 90066959
Skin exfoliation 195.84 17.98 74 524883 67839 90035651
Pneumonia aspiration 195.53 17.98 10 524947 40930 90062560
Adverse drug reaction 193.48 17.98 1248 523709 115453 89988037
Disturbance in attention 193.04 17.98 23 524934 47086 90056404
Dysgeusia 191.66 17.98 36 524921 52524 90050966
Orthostatic hypotension 191.30 17.98 13 524944 41814 90061676
Aphasia 190.96 17.98 15 524942 42797 90060693
Weight increased 189.46 17.98 3437 521520 414490 89689000
Myocardial infarction 188.60 17.98 201 524756 105771 89997719
Accidental exposure to product 188.53 17.98 15 524942 42351 90061139
Alanine aminotransferase increased 186.53 17.98 247 524710 118091 89985399
Chronic obstructive pulmonary disease 185.37 17.98 98 524859 73731 90029759
Urinary retention 184.21 17.98 8 524949 37736 90065754
Lymphocyte count decreased 183.35 17.98 4 524953 35046 90068444
Sciatica 182.94 17.98 1108 523849 100274 90003216
Mental status changes 182.62 17.98 22 524935 44657 90058833
Lower limb fracture 182.29 17.98 973 523984 84040 90019450
Bursitis 182.24 17.98 1347 523610 130307 89973183
Thrombosis 181.32 17.98 99 524858 73152 90030338
Hypophagia 180.92 17.98 6 524951 35931 90067559
Agranulocytosis 179.27 17.98 5 524952 34997 90068493
Full blood count abnormal 177.81 17.98 8 524949 36589 90066901
Blood alkaline phosphatase increased 177.31 17.98 32 524925 48047 90055443
Product distribution issue 176.91 17.98 157 524800 3548 90099942
Peripheral venous disease 176.21 17.98 955 524002 82966 90020524
Anxiety 175.32 17.98 1063 523894 308709 89794781
Pneumonia 171.13 17.98 2633 522324 635426 89468064
Vertigo 170.42 17.98 96 524861 69715 90033775
Macular degeneration 170.21 17.98 13 524944 37957 90065533
Nasal congestion 169.86 17.98 140 524817 83274 90020216
Pericardial effusion 169.78 17.98 11 524946 36822 90066668
Respiratory arrest 169.72 17.98 5 524952 33306 90070184
Colitis 168.14 17.98 98 524859 69844 90033646
Wound infection 167.35 17.98 1123 523834 105279 89998211
Tinnitus 167.18 17.98 25 524932 43077 90060413
Device dislocation 167.07 17.98 3 524954 31479 90072011
Hepatic function abnormal 166.04 17.98 33 524924 46255 90057235
Emotional distress 165.92 17.98 12 524945 36650 90066840
Cholelithiasis 165.74 17.98 49 524908 52457 90051033
Adjustment disorder with depressed mood 164.81 17.98 709 524248 56044 90047446
Respiratory distress 164.68 17.98 17 524940 38929 90064561
Fatigue 163.97 17.98 8208 516749 1145815 88957675
Liver function test abnormal 163.17 17.98 46 524911 50799 90052691
Hypomagnesaemia 162.94 17.98 11 524946 35577 90067913
Speech disorder 162.47 17.98 33 524924 45552 90057938
Aspartate aminotransferase increased 162.09 17.98 215 524742 102722 90000768
Condition aggravated 161.62 17.98 4554 520403 590991 89512499
Haemorrhage 161.43 17.98 101 524856 69268 90034222
Nail disorder 160.97 17.98 724 524233 58343 90045147
Septic shock 160.80 17.98 150 524807 84010 90019480
Therapeutic product effect incomplete 160.46 17.98 1774 523183 192122 89911368
Onychomycosis 160.21 17.98 529 524428 36847 90066643
Transient ischaemic attack 158.66 17.98 29 524928 43147 90060343
Melaena 158.60 17.98 11 524946 34786 90068704
Haematocrit decreased 158.32 17.98 26 524931 41806 90061684
Blood potassium decreased 157.26 17.98 41 524916 47686 90055804
Haematochezia 157.24 17.98 109 524848 70804 90032686
Altered state of consciousness 156.18 17.98 6 524951 31526 90071964
Cholestasis 155.69 17.98 15 524942 36284 90067206
Injection site reaction 155.26 17.98 989 523968 91091 90012399
Pain in jaw 154.75 17.98 43 524914 47942 90055548
Urinary incontinence 152.31 17.98 19 524938 37547 90065943
Jaundice 152.01 17.98 9 524948 32508 90070982
Throat irritation 150.89 17.98 47 524910 48648 90054842
Obesity 149.73 17.98 1086 523871 104421 89999069
Swollen tongue 148.55 17.98 41 524916 45915 90057575
Generalised tonic-clonic seizure 148.19 17.98 15 524942 34888 90068602
Hemiparesis 148.16 17.98 9 524948 31810 90071680
Presyncope 148.09 17.98 9 524948 31796 90071694
Arrhythmia 148.08 17.98 32 524925 42300 90061190
Hypothyroidism 148.07 17.98 61 524896 53066 90050424
Live birth 147.46 17.98 872 524085 78235 90025255
Restlessness 147.46 17.98 17 524940 35703 90067787
Pneumonitis 147.35 17.98 37 524920 44133 90059357
Intentional self-injury 147.31 17.98 5 524952 29329 90074161
Onychomadesis 146.37 17.98 591 524366 45407 90058083
Cerebral haemorrhage 146.15 17.98 15 524942 34507 90068983
Drug level increased 145.89 17.98 3 524954 27759 90075731
Full blood count decreased 145.86 17.98 6 524951 29683 90073807
Ear pain 145.23 17.98 691 524266 57011 90046479
Depressed mood 144.35 17.98 55 524902 50167 90053323
Blood urea increased 143.46 17.98 8 524949 30405 90073085
Oedema peripheral 143.32 17.98 890 524067 257025 89846465
Blood pressure fluctuation 143.16 17.98 62 524895 52351 90051139
Sinus tachycardia 142.70 17.98 5 524952 28508 90074982
Dislocation of vertebra 142.15 17.98 672 524285 55296 90048194
Sleep apnoea syndrome 141.94 17.98 11 524946 31736 90071754
Shock 140.77 17.98 6 524951 28772 90074718
Breast feeding 139.64 17.98 78 524879 805 90102685
Red blood cell count decreased 139.63 17.98 47 524910 46304 90057186
Hot flush 137.89 17.98 87 524870 59401 90044089
Stevens-Johnson syndrome 137.73 17.98 8 524949 29368 90074122
Haemoptysis 137.19 17.98 16 524941 33304 90070186
Pulmonary arterial hypertension 136.94 17.98 3 524954 26184 90077306
Haematemesis 136.88 17.98 17 524940 33709 90069781
X-ray abnormal 136.17 17.98 573 524384 44851 90058639
Asthenia 136.14 17.98 2223 522734 531528 89571962
Drug tolerance decreased 135.26 17.98 452 524505 31678 90071812
Cardiac disorder 134.85 17.98 81 524876 56791 90046699
Transaminases increased 134.49 17.98 26 524931 37166 90066324
Angina pectoris 134.17 17.98 31 524926 39129 90064361
Haematuria 133.82 17.98 21 524936 34916 90068574
Psychotic disorder 133.70 17.98 13 524944 31217 90072273
Blood creatine phosphokinase increased 133.66 17.98 19 524938 34004 90069486
Acute myocardial infarction 133.58 17.98 21 524936 34869 90068621
Irritability 133.11 17.98 23 524934 35639 90067851
Red blood cell sedimentation rate increased 133.05 17.98 877 524080 81718 90021772
Road traffic accident 132.71 17.98 1072 523885 106554 89996936
Leukocytosis 132.41 17.98 13 524944 30977 90072513
Pallor 132.09 17.98 20 524937 34145 90069345
Obstructive airways disorder 131.37 17.98 4 524953 25865 90077625
Eosinophilia 130.11 17.98 9 524948 28524 90074966
Femur fracture 129.91 17.98 52 524905 46030 90057460
C-reactive protein increased 129.84 17.98 1614 523343 179775 89923715
Hepatocellular injury 129.56 17.98 10 524947 28948 90074542
Pruritus 129.49 17.98 4077 520880 537448 89566042
Metastases to liver 128.74 17.98 10 524947 28797 90074693
Gamma-glutamyltransferase increased 128.14 17.98 31 524926 37921 90065569
Blood calcium decreased 128.07 17.98 13 524944 30169 90073321
Swelling face 127.99 17.98 170 524787 81182 90022308
Haematoma 127.79 17.98 34 524923 39014 90064476
Blood pressure systolic increased 127.62 17.98 91 524866 58254 90045236
Ejection fraction decreased 126.69 17.98 6 524951 26247 90077243
Rheumatoid nodule 126.47 17.98 327 524630 19839 90083651
Drug dependence 126.10 17.98 12 524945 29315 90074175
Prescribed underdose 126.00 17.98 805 524152 74214 90029276
Blood sodium decreased 125.07 17.98 9 524948 27604 90075886
Coronary artery disease 124.81 17.98 22 524935 33601 90069889
Lupus vulgaris 124.05 17.98 554 524403 44505 90058985
Metastases to bone 122.53 17.98 6 524951 25499 90077991
Hepatic cytolysis 122.08 17.98 17 524940 30899 90072591
Blood lactate dehydrogenase increased 121.77 17.98 7 524950 25925 90077565
Ventricular tachycardia 121.37 17.98 5 524952 24703 90078787
Respiratory disorder 121.14 17.98 715 524242 64101 90039389
Muscle spasticity 120.60 17.98 464 524493 34858 90068632
Rash erythematous 119.77 17.98 120 524837 64984 90038506
Oropharyngeal pain 118.94 17.98 311 524646 114876 89988614
Rash maculo-papular 117.35 17.98 45 524912 40888 90062602
Pancreatitis acute 117.08 17.98 22 524935 32093 90071397
Dysuria 116.87 17.98 41 524916 39360 90064130
Proteinuria 116.85 17.98 4 524953 23287 90080203
Exostosis 116.53 17.98 612 524345 52522 90050968
Joint stiffness 116.35 17.98 813 524144 77229 90026261
C-reactive protein 116.21 17.98 423 524534 30944 90072546
Upper gastrointestinal haemorrhage 115.08 17.98 4 524953 22972 90080518
Paraesthesia oral 114.76 17.98 22 524935 31637 90071853
Drug ineffective for unapproved indication 114.60 17.98 130 524827 66514 90036976
Aggression 114.43 17.98 11 524946 26657 90076833
Procedural pain 113.12 17.98 27 524930 33333 90070157
Anti-cyclic citrullinated peptide antibody 112.87 17.98 381 524576 26840 90076650
Head injury 112.36 17.98 22 524935 31166 90072324
Joint dislocation 111.54 17.98 533 524424 44049 90059441
Acute respiratory distress syndrome 110.43 17.98 17 524940 28669 90074821
Skin haemorrhage 109.69 17.98 3 524954 21377 90082113
Cytomegalovirus infection 108.97 17.98 13 524944 26589 90076901
Flatulence 108.20 17.98 52 524905 41315 90062175
Lymphopenia 107.98 17.98 6 524951 22875 90080615
Circulatory collapse 107.58 17.98 10 524947 24894 90078596
Skin lesion 107.25 17.98 41 524916 37324 90066166
Coagulopathy 107.21 17.98 7 524950 23282 90080208
Nervousness 107.09 17.98 32 524925 34024 90069466
Renal disorder 106.27 17.98 43 524914 37816 90065674
Hypoacusis 106.09 17.98 17 524940 27833 90075657
Accidental overdose 106.04 17.98 18 524939 28255 90075235
Oral pain 105.93 17.98 29 524928 32654 90070836
Lip swelling 104.93 17.98 46 524911 38564 90064926
Blepharospasm 104.50 17.98 613 524344 54832 90048658
Blindness 103.99 17.98 15 524942 26553 90076937
Diplopia 103.98 17.98 20 524937 28694 90074796
Fluid retention 103.58 17.98 222 524735 87869 90015621
Abnormal behaviour 103.58 17.98 7 524950 22621 90080869
Osteoarthritis 103.54 17.98 1651 523306 194079 89909411
Eye pruritus 103.47 17.98 21 524936 29006 90074484
Blood pressure diastolic decreased 103.03 17.98 16 524941 26810 90076680
Tubulointerstitial nephritis 102.30 17.98 13 524944 25330 90078160
Body temperature increased 102.23 17.98 521 524436 44189 90059301
Lupus-like syndrome 100.59 17.98 553 524404 48293 90055197
Disseminated intravascular coagulation 100.56 17.98 6 524951 21532 90081958
Mental disorder 100.48 17.98 31 524926 32287 90071203
Product label confusion 100.25 17.98 326 524631 22524 90080966
Retinitis 100.02 17.98 465 524492 37993 90065497
Feeling cold 99.73 17.98 19 524938 27446 90076044
Visual acuity reduced 99.54 17.98 10 524947 23400 90080090
Product administration error 98.71 17.98 17 524940 26406 90077084
Abdominal pain 98.53 17.98 1655 523302 394066 89709424
Loss of consciousness 98.44 17.98 447 524510 139791 89963699
Device issue 98.03 17.98 25 524932 29512 90073978
Cataract 97.59 17.98 167 524790 71925 90031565
Withdrawal syndrome 97.42 17.98 9 524948 22515 90080975
Diabetic ketoacidosis 97.37 17.98 13 524944 24394 90079096
Restless legs syndrome 97.13 17.98 9 524948 22461 90081029
Myelodysplastic syndrome 97.06 17.98 6 524951 20897 90082593
Infusion site pain 96.93 17.98 4 524953 19734 90083756
Crying 96.91 17.98 16 524941 25629 90077861
Heart rate irregular 96.64 17.98 13 524944 24255 90079235
Chronic sinusitis 96.59 17.98 12 524945 23790 90079700
Hypoaesthesia 96.56 17.98 2443 522514 311767 89791723
Sneezing 95.88 17.98 27 524930 29842 90073648
Acute myeloid leukaemia 95.62 17.98 6 524951 20634 90082856
Blood pressure systolic abnormal 95.48 17.98 4 524953 19474 90084016
Hip fracture 95.43 17.98 36 524921 33041 90070449
Cyanosis 95.35 17.98 4 524953 19451 90084039
Complication associated with device 95.32 17.98 4 524953 19445 90084045
Eye pain 95.15 17.98 70 524887 44098 90059392
Inability to afford medication 94.91 17.98 111 524846 3511 90099979
Mitral valve incompetence 94.80 17.98 10 524947 22514 90080976
Dry eye 94.28 17.98 118 524839 57813 90045677
Panic attack 94.14 17.98 19 524938 26346 90077144
Muscle twitching 93.95 17.98 14 524943 24188 90079302
Tachypnoea 93.55 17.98 8 524949 21301 90082189
Multiple sclerosis 93.49 17.98 23 524934 27817 90075673
Eating disorder 92.71 17.98 24 524933 28049 90075441
Dermatitis atopic 92.46 17.98 13 524944 23459 90080031
Dementia 92.17 17.98 14 524943 23847 90079643
Acute hepatic failure 90.04 17.98 12 524945 22549 90080941
Eczema 89.96 17.98 104 524853 52766 90050724
Intentional product misuse 89.43 17.98 246 524711 89358 90014132
Electrolyte imbalance 89.32 17.98 15 524942 23730 90079760
Coordination abnormal 88.56 17.98 10 524947 21346 90082144
Impaired quality of life 88.44 17.98 14 524943 23130 90080360
Diabetes mellitus 88.08 17.98 150 524807 64725 90038765
Prescribed overdose 88.07 17.98 909 524048 96716 90006774
Nightmare 88.04 17.98 11 524946 21714 90081776
Rib fracture 86.54 17.98 23 524934 26412 90077078
Bacteraemia 86.33 17.98 13 524944 22287 90081203
Ischaemic stroke 85.64 17.98 13 524944 22153 90081337
Coeliac disease 85.23 17.98 495 524462 44115 90059375
Hyperlipidaemia 85.05 17.98 15 524942 22901 90080589
Motor dysfunction 85.03 17.98 7 524950 19223 90084267
Metastases to central nervous system 84.68 17.98 4 524953 17538 90085952
Sensory loss 84.50 17.98 5 524952 18070 90085420
Drug tolerance 84.44 17.98 262 524695 17654 90085836
Musculoskeletal pain 84.43 17.98 1428 523529 169823 89933667
Clostridium difficile colitis 84.14 17.98 25 524932 26681 90076809
Product substitution issue 84.13 17.98 5 524952 18003 90085487
Device malfunction 84.10 17.98 11 524946 20966 90082524
Cerebral infarction 83.61 17.98 25 524932 26571 90076919
Adverse reaction 83.06 17.98 367 524590 29345 90074145
Cellulitis 83.01 17.98 262 524695 91075 90012415
Influenza 82.89 17.98 470 524487 138794 89964696
Bronchospasm 82.69 17.98 11 524946 20698 90082792
Haemorrhoids 82.32 17.98 26 524931 26676 90076814
Vaginal haemorrhage 82.26 17.98 39 524918 31232 90072258
Diabetes mellitus inadequate control 82.07 17.98 7 524950 18677 90084813
Back injury 81.83 17.98 506 524451 46116 90057374
Blood glucose decreased 81.36 17.98 18 524939 23411 90080079
Poor venous access 81.34 17.98 9 524948 19518 90083972
Hemiplegia 80.29 17.98 3 524954 16157 90087333
Cystitis 80.23 17.98 166 524791 66552 90036938
Hyperthyroidism 80.04 17.98 7 524950 18303 90085187
Fear 79.57 17.98 4 524953 16618 90086872
Systemic lupus erythematosus rash 79.53 17.98 83 524874 2306 90101184
Gastritis 79.07 17.98 75 524882 41678 90061812
Caesarean section 78.78 17.98 262 524695 18315 90085175
Pustular psoriasis 78.06 17.98 261 524696 18295 90085195
Poor quality sleep 78.01 17.98 23 524934 24670 90078820
Liver function test increased 77.92 17.98 793 524164 84062 90019428
Polyneuropathy 77.88 17.98 10 524947 19331 90084159
Body temperature decreased 77.44 17.98 21 524936 23795 90079695
Peritonitis 77.42 17.98 11 524946 19694 90083796
Rhinitis allergic 77.40 17.98 5 524952 16780 90086710
Myoclonus 76.97 17.98 10 524947 19158 90084332
Face oedema 76.88 17.98 20 524937 23298 90080192
Subdural haematoma 76.63 17.98 5 524952 16640 90086850
Therapy partial responder 76.42 17.98 17 524940 22026 90081464
Rash macular 76.29 17.98 40 524917 30240 90073250
Hepatic cirrhosis 75.77 17.98 626 524331 62627 90040863
Disease recurrence 75.66 17.98 64 524893 37589 90065901
Transfusion 75.60 17.98 7 524950 17481 90086009
Glomerular filtration rate decreased 75.32 17.98 6 524951 16926 90086564
Abdominal pain lower 74.36 17.98 41 524916 30136 90073354
Cardiac murmur 74.25 17.98 9 524948 18185 90085305
Mental impairment 74.17 17.98 6 524951 16714 90086776
COVID-19 pneumonia 74.16 17.98 9 524948 18168 90085322
Bone disorder 74.03 17.98 21 524936 23099 90080391
Neutrophil count increased 73.49 17.98 12 524945 19378 90084112
Schizophrenia 73.31 17.98 3 524954 14911 90088579
Ileus 73.22 17.98 6 524951 16540 90086950
Limb injury 73.13 17.98 46 524911 31462 90072028
Eye irritation 73.00 17.98 54 524903 33924 90069566
Hypophosphataemia 72.98 17.98 3 524954 14851 90088639
Female genital tract fistula 72.53 17.98 9 524948 17859 90085631
Hypoalbuminaemia 72.52 17.98 5 524952 15892 90087598
Sinus disorder 72.40 17.98 56 524901 34391 90069099
Retching 72.29 17.98 12 524945 19147 90084343
Left ventricular dysfunction 71.94 17.98 3 524954 14666 90088824
Tricuspid valve incompetence 71.53 17.98 7 524950 16724 90086766
Device related infection 71.22 17.98 30 524927 25756 90077734
Radiculopathy 71.15 17.98 11 524946 18494 90084996
Skin fissures 70.25 17.98 17 524940 20792 90082698
Pollakiuria 70.20 17.98 53 524904 32952 90070538
SARS-CoV-2 test negative 69.65 17.98 42 524915 506 90102984
Blood parathyroid hormone decreased 69.43 17.98 191 524766 12025 90091465
Skin laceration 69.21 17.98 32 524925 26003 90077487
Walking aid user 67.84 17.98 394 524563 35112 90068378
Lacrimation increased 67.81 17.98 36 524921 27026 90076464
Cardiomyopathy 67.25 17.98 17 524940 20189 90083301
Sputum discoloured 66.26 17.98 18 524939 20373 90083117
Hiatus hernia 66.15 17.98 32 524925 25329 90078161
Dry mouth 65.61 17.98 1461 523496 182598 89920892
Breast cancer metastatic 65.57 17.98 6 524951 15126 90088364
Lung disorder 65.06 17.98 1225 523732 148658 89954832
Colitis microscopic 64.95 17.98 176 524781 10983 90092507
Osteopenia 64.76 17.98 26 524931 22976 90080514
Rectal haemorrhage 64.69 17.98 253 524704 82491 90020999
Stress cardiomyopathy 64.61 17.98 3 524954 13352 90090138
Blood albumin decreased 64.58 17.98 10 524947 16793 90086697
Toothache 64.46 17.98 24 524933 22206 90081284
Drug hypersensitivity 64.42 17.98 3293 521664 460316 89643174
Pneumothorax 64.04 17.98 16 524941 19151 90084339
Feeding disorder 63.83 17.98 12 524945 17500 90085990
Blood pressure diastolic abnormal 63.76 17.98 18 524939 19863 90083627
Granuloma skin 63.72 17.98 170 524787 10510 90092980
Food allergy 63.68 17.98 34 524923 25444 90078046
Proctitis 63.64 17.98 7 524950 15252 90088238
Vaginal discharge 63.59 17.98 17 524940 19447 90084043
Finger deformity 63.47 17.98 366 524591 32531 90070959
Blood magnesium decreased 63.46 17.98 8 524949 15685 90087805
Acute generalised exanthematous pustulosis 63.43 17.98 4 524953 13699 90089791
Mania 62.84 17.98 5 524952 14119 90089371
COVID-19 62.56 17.98 650 524307 168193 89935297
Supraventricular tachycardia 62.16 17.98 10 524947 16326 90087164
Drug resistance 62.11 17.98 51 524906 30398 90073092
Gangrene 61.95 17.98 3 524954 12873 90090617
Throat tightness 61.88 17.98 48 524909 29436 90074054
Osteonecrosis 61.33 17.98 38 524919 26203 90077287
Lung infiltration 61.30 17.98 8 524949 15274 90088216
Acidosis 61.17 17.98 3 524954 12733 90090757
Myocarditis 61.11 17.98 5 524952 13801 90089689
Gastric ulcer 61.09 17.98 42 524915 27406 90076084
Cardiomegaly 60.95 17.98 17 524940 18908 90084582
Blood triglycerides increased 60.87 17.98 5 524952 13756 90089734
Lymphoedema 60.83 17.98 5 524952 13748 90089742
Ageusia 60.81 17.98 10 524947 16066 90087424
Laryngitis 60.63 17.98 502 524455 50251 90053239
Red blood cell sedimentation rate 60.63 17.98 102 524855 4556 90098934
Skin discolouration 60.58 17.98 102 524855 44213 90059277
Metastases to lung 60.37 17.98 10 524947 15981 90087509
Neuralgia 60.33 17.98 56 524901 31444 90072046
Hallucination, auditory 60.29 17.98 10 524947 15965 90087525
Seronegative arthritis 60.18 17.98 237 524720 17997 90085493
Eosinophil count increased 60.01 17.98 4 524953 13077 90090413
Headache 59.93 17.98 4247 520710 858499 89244991
Cold sweat 59.91 17.98 6 524951 14075 90089415
Sensory disturbance 59.63 17.98 9 524948 15404 90088086
Arterial occlusive disease 59.56 17.98 3 524954 12443 90091047
Personality disorder 59.55 17.98 3 524954 12441 90091049
Malnutrition 59.15 17.98 17 524940 18541 90084949
Delusion 58.62 17.98 6 524951 13834 90089656
Ankle arthroplasty 58.49 17.98 77 524880 2754 90100736
Oesophagitis 58.41 17.98 14 524943 17235 90086255
Influenza like illness 58.33 17.98 254 524703 80357 90023133
Respiratory rate increased 58.25 17.98 11 524946 15990 90087500
Therapeutic response unexpected 58.00 17.98 27 524930 21853 90081637
Maternal exposure timing unspecified 57.84 17.98 271 524686 22212 90081278
Subarachnoid haemorrhage 57.81 17.98 16 524941 17888 90085602
Blood calcium increased 57.41 17.98 3 524954 12055 90091435
Urine output decreased 57.39 17.98 4 524953 12599 90090891
Choking 57.27 17.98 3 524954 12030 90091460
Chest pain 57.05 17.98 1412 523545 318233 89785257
Pseudomonas infection 56.79 17.98 9 524948 14856 90088634
Cardiac failure acute 56.69 17.98 3 524954 11926 90091564
Splenomegaly 56.34 17.98 5 524952 12919 90090571
Panniculitis 56.13 17.98 198 524759 14260 90089230
Musculoskeletal chest pain 56.06 17.98 34 524923 23716 90079774
Upper-airway cough syndrome 55.96 17.98 10 524947 15125 90088365
Haemodynamic instability 55.64 17.98 3 524954 11736 90091754
Metastases to lymph nodes 55.36 17.98 3 524954 11686 90091804
Chromaturia 55.16 17.98 21 524936 19166 90084324
Facial pain 55.10 17.98 6 524951 13176 90090314
Glaucoma 54.74 17.98 252 524705 20503 90082987
Purpura 54.14 17.98 10 524947 14768 90088722
Mood altered 54.10 17.98 16 524941 17128 90086362
Middle insomnia 54.03 17.98 15 524942 16736 90086754
Incontinence 53.97 17.98 7 524950 13428 90090062
Bronchopulmonary aspergillosis 53.75 17.98 3 524954 11395 90092095
Hepatomegaly 53.39 17.98 7 524950 13319 90090171
Hepatic encephalopathy 53.38 17.98 8 524949 13764 90089726
Decubitus ulcer 53.07 17.98 4 524953 11809 90091681
Pelvic pain 52.92 17.98 12 524945 15345 90088145
Petechiae 52.86 17.98 13 524944 15728 90087762
Foetal death 52.76 17.98 27 524930 20696 90082794
Rash papular 52.61 17.98 26 524931 20329 90083161
Faeces discoloured 52.49 17.98 29 524928 21291 90082199
Head discomfort 51.99 17.98 15 524942 16318 90087172
Glycosylated haemoglobin increased 51.97 17.98 13 524944 15549 90087941
Tenosynovitis 51.90 17.98 194 524763 14373 90089117
Haemophagocytic lymphohistiocytosis 51.46 17.98 13 524944 15446 90088044
Seasonal allergy 51.38 17.98 35 524922 22948 90080542
Rales 51.37 17.98 14 524943 15813 90087677
Myocardial ischaemia 51.36 17.98 9 524948 13805 90089685
Hypocalcaemia 51.29 17.98 105 524852 42263 90061227
Wheezing 51.21 17.98 1771 523186 236309 89867181
Dysstasia 51.05 17.98 42 524915 25010 90078480
Blood pressure abnormal 50.91 17.98 25 524932 19620 90083870
Eructation 50.90 17.98 3 524954 10879 90092611
Anger 50.87 17.98 9 524948 13711 90089779
Arteriosclerosis 50.74 17.98 3 524954 10850 90092640
Hypokinesia 50.74 17.98 14 524943 15683 90087807
Spinal compression fracture 50.07 17.98 13 524944 15165 90088325
Abnormal dreams 50.04 17.98 4 524953 11253 90092237
Oral candidiasis 49.96 17.98 80 524877 35375 90068115
Skin abrasion 49.92 17.98 4 524953 11231 90092259
Thinking abnormal 49.91 17.98 5 524952 11727 90091763
Affect lability 49.91 17.98 21 524936 18042 90085448
Product complaint 49.74 17.98 9 524948 13491 90089999
Anal incontinence 49.68 17.98 16 524941 16214 90087276
Hepatic steatosis 49.62 17.98 86 524871 36859 90066631
Liver disorder 49.52 17.98 982 523975 120287 89983203
Enthesopathy 49.50 17.98 143 524814 9261 90094229
Intestinal obstruction 49.35 17.98 87 524870 37044 90066446
Toxic skin eruption 49.27 17.98 15 524942 15759 90087731
Clostridium difficile infection 49.01 17.98 84 524873 36161 90067329
Heavy menstrual bleeding 49.00 17.98 29 524928 20501 90082989
Spinal fracture 48.59 17.98 34 524923 21982 90081508
Thirst 48.25 17.98 17 524940 16278 90087212
Sudden death 48.15 17.98 4 524953 10905 90092585
Blood test abnormal 48.06 17.98 31 524926 20921 90082569
Gastrooesophageal reflux disease 48.02 17.98 676 524281 165661 89937829
Intestinal perforation 47.53 17.98 11 524946 13870 90089620
Feeling hot 47.10 17.98 262 524695 77746 90025744
Immune thrombocytopenia 46.76 17.98 10 524947 13316 90090174
Product administration interrupted 46.75 17.98 8 524949 12484 90091006
Paranoia 46.72 17.98 9 524948 12899 90090591
Twin pregnancy 46.51 17.98 46 524911 1197 90102293
Major depression 46.24 17.98 3 524954 10032 90093458
Gout 45.95 17.98 20 524937 16839 90086651
Emotional disorder 45.53 17.98 15 524942 14982 90088508
Burning sensation 45.26 17.98 201 524756 63251 90040239
Anosmia 45.21 17.98 3 524954 9845 90093645
Treatment noncompliance 45.17 17.98 151 524806 51576 90051914
Epstein-Barr virus infection 45.09 17.98 4 524953 10340 90093150
Hyperthermia 45.04 17.98 4 524953 10331 90093159
Gastroenteritis 45.03 17.98 62 524895 29167 90074323
Joint destruction 44.91 17.98 174 524783 13113 90090377
Nocturia 44.61 17.98 4 524953 10251 90093239
Sinus congestion 44.48 17.98 56 524901 27368 90076122
Eye haemorrhage 44.21 17.98 4 524953 10176 90093314
Adjustment disorder 44.08 17.98 3 524954 9639 90093851
Small intestinal obstruction 44.02 17.98 35 524922 21199 90082291
Hypersomnia 43.99 17.98 36 524921 21495 90081995
Incorrect dose administered 43.98 17.98 272 524685 78658 90024832
Lymphadenopathy 43.22 17.98 129 524828 45646 90057844
Device leakage 43.19 17.98 4 524953 9987 90093503
Enterococcal infection 43.19 17.98 4 524953 9987 90093503
Gallbladder disorder 43.15 17.98 31 524926 19772 90083718
Escherichia infection 43.09 17.98 19 524938 15876 90087614
Asthma 42.84 17.98 1071 523886 241089 89862401
Abdominal pain upper 42.74 17.98 2346 522611 330328 89773162
Rebound effect 42.67 17.98 3 524954 9381 90094109
Atelectasis 42.63 17.98 47 524910 24362 90079128
Aspergillus infection 42.62 17.98 6 524951 10817 90092673
Intervertebral disc protrusion 42.60 17.98 57 524900 27139 90076351
Central nervous system lesion 42.41 17.98 8 524949 11638 90091852
Tenderness 42.40 17.98 56 524901 26812 90076678
Cholecystitis 42.21 17.98 23 524934 17017 90086473
Foetal exposure during pregnancy 42.12 17.98 119 524838 42856 90060634
Blood pressure systolic decreased 42.04 17.98 3 524954 9267 90094223
Prothrombin time prolonged 42.01 17.98 4 524953 9768 90093722
Arthrodesis 41.95 17.98 68 524889 2944 90100546
Skin disorder 41.91 17.98 94 524863 36612 90066878
Hypogammaglobulinaemia 41.84 17.98 6 524951 10668 90092822
Bedridden 41.81 17.98 160 524797 11988 90091502
Concomitant disease aggravated 41.75 17.98 8 524949 11510 90091980
Eye swelling 41.70 17.98 66 524891 29320 90074170
Vitamin D deficiency 41.62 17.98 25 524932 17531 90085959
Apathy 41.47 17.98 7 524950 11033 90092457
Surgery 40.96 17.98 419 524538 44468 90059022
Blood iron decreased 40.61 17.98 27 524930 17932 90085558
Blood glucose abnormal 40.50 17.98 4 524953 9488 90094002
Micturition urgency 40.30 17.98 8 524949 11225 90092265
Hypoaesthesia oral 40.21 17.98 20 524937 15580 90087910
Apnoea 40.08 17.98 4 524953 9410 90094080
Cholecystitis acute 40.03 17.98 4 524953 9400 90094090
Lipase increased 39.68 17.98 8 524949 11103 90092387
Nail operation 39.63 17.98 52 524905 1854 90101636
Abdominal tenderness 39.60 17.98 4 524953 9320 90094170
Pain of skin 39.41 17.98 22 524935 16060 90087430
Depression 39.33 17.98 1385 523572 299216 89804274
Deformity 39.21 17.98 157 524800 12013 90091477
Peripheral sensory neuropathy 39.20 17.98 4 524953 9246 90094244
Hospice care 39.11 17.98 5 524952 9699 90093791
Aphthous ulcer 39.08 17.98 26 524931 17261 90086229
Candida infection 39.06 17.98 87 524870 33970 90069520
Hypermobility syndrome 38.98 17.98 36 524921 858 90102632
Platelet count increased 38.87 17.98 38 524919 20821 90082669
Pre-existing condition improved 38.77 17.98 4 524953 9165 90094325
Diverticulum intestinal 38.62 17.98 4 524953 9138 90094352
Transaminases abnormal 38.53 17.98 33 524924 710 90102780
Nervous system disorder 38.35 17.98 41 524916 21552 90081938
Pemphigoid 38.00 17.98 4 524953 9022 90094468
Ulcer haemorrhage 37.93 17.98 272 524685 26049 90077441
Blood urine present 37.71 17.98 27 524930 17251 90086239
Aspiration 37.69 17.98 22 524935 15671 90087819
Pancreatitis 37.68 17.98 243 524714 69583 90033907
Post procedural complication 37.48 17.98 33 524924 19009 90084481
Device difficult to use 37.45 17.98 28 524929 17497 90085993
Injection site pallor 37.44 17.98 15 524942 66 90103424
Wrist fracture 37.39 17.98 22 524935 15602 90087888
Spondylitis 37.28 17.98 172 524785 14006 90089484
Psoriasis 37.18 17.98 1120 523837 146634 89956856
Breast cancer female 37.01 17.98 20 524937 14866 90088624
Bacterial infection 36.86 17.98 49 524908 23395 90080095
Axial spondyloarthritis 36.81 17.98 30 524927 601 90102889
Insomnia 36.81 17.98 2320 522637 331154 89772336
Breast cancer stage II 36.75 17.98 339 524618 34995 90068495
Hepatitis acute 36.54 17.98 9 524948 10878 90092612
Foot operation 36.45 17.98 125 524832 8876 90094614
Genital haemorrhage 36.27 17.98 4 524953 8698 90094792
Premature labour 36.24 17.98 16 524941 13360 90090130
Ecchymosis 36.24 17.98 13 524944 12310 90091180
Decreased appetite 35.94 17.98 1798 523159 374742 89728748
Renal cyst 35.87 17.98 15 524942 12935 90090555
Electrocardiogram abnormal 35.58 17.98 8 524949 10290 90093200
Hepatitis cholestatic 35.52 17.98 4 524953 8557 90094933
Ear infection 35.15 17.98 584 524373 69191 90034299
Amenorrhoea 35.10 17.98 12 524945 11710 90091780
Ankylosing spondylitis 35.04 17.98 160 524797 12973 90090517
Temperature intolerance 34.86 17.98 13 524944 12017 90091473
White blood cell count increased 34.78 17.98 237 524720 67004 90036486
Dyslipidaemia 34.62 17.98 8 524949 10099 90093391
Bundle branch block left 34.51 17.98 3 524954 7882 90095608
Blood disorder 33.99 17.98 3 524954 7787 90095703
Paralysis 33.94 17.98 12 524945 11466 90092024
Syringe issue 33.92 17.98 73 524884 3929 90099561
Emphysema 33.80 17.98 14 524943 12141 90091349
Blood uric acid increased 33.53 17.98 3 524954 7701 90095789
Hydronephrosis 33.35 17.98 15 524942 12387 90091103
Wrong product administered 33.32 17.98 3 524954 7662 90095828
Polyp 33.20 17.98 3 524954 7641 90095849
Eyelid ptosis 33.19 17.98 6 524951 9000 90094490
Low density lipoprotein increased 32.99 17.98 4 524953 8081 90095409
Carpal tunnel syndrome 32.77 17.98 55 524902 23873 90079617
Tooth loss 32.72 17.98 3 524954 7551 90095939
Scoliosis 32.69 17.98 6 524951 8901 90094589
Initial insomnia 32.64 17.98 7 524950 9303 90094187
Eyelid oedema 32.53 17.98 13 524944 11521 90091969
Faeces soft 32.49 17.98 3 524954 7508 90095982
Nerve injury 32.43 17.98 139 524818 10967 90092523
Failure to thrive 32.34 17.98 5 524952 8406 90095084
Metabolic disorder 32.26 17.98 3 524954 7467 90096023
Nephropathy 32.26 17.98 7 524950 9228 90094262
Diverticulum 32.03 17.98 15 524942 12098 90091392
Increased appetite 31.99 17.98 14 524943 11751 90091739
Skin necrosis 31.72 17.98 187 524770 16754 90086736
Therapy non-responder 31.69 17.98 1026 523931 135678 89967812
Ligament sprain 31.62 17.98 23 524934 14576 90088914
Affective disorder 31.45 17.98 4 524953 7789 90095701
Extremity contracture 31.21 17.98 38 524919 1255 90102235
Decreased activity 31.20 17.98 5 524952 8187 90095303
Blindness unilateral 31.15 17.98 4 524953 7732 90095758
Large intestine polyp 31.04 17.98 8 524949 9378 90094112
Red cell distribution width increased 30.94 17.98 16 524941 12191 90091299
Device use error 30.92 17.98 3 524954 7218 90096272
Viral infection 30.87 17.98 129 524828 41285 90062205
Drug level decreased 30.85 17.98 9 524948 9721 90093769
Cerebral ischaemia 30.79 17.98 3 524954 7193 90096297
Impaired gastric emptying 30.70 17.98 18 524939 12791 90090699
Muscle tightness 30.67 17.98 20 524937 13419 90090071
Muscle strain 30.64 17.98 9 524948 9678 90093812
Mouth haemorrhage 30.61 17.98 6 524951 8495 90094995
Atrial flutter 30.55 17.98 12 524945 10746 90092744
Bradyphrenia 30.49 17.98 4 524953 7608 90095882
Lung neoplasm malignant 30.37 17.98 59 524898 24214 90079276
Asphyxia 30.29 17.98 3 524954 7100 90096390
Stress 30.27 17.98 313 524644 81082 90022408
Protein total decreased 30.21 17.98 3 524954 7086 90096404
Uterine perforation 30.19 17.98 4 524953 7550 90095940
Photophobia 29.96 17.98 48 524909 21221 90082269
Rhinitis 29.90 17.98 21 524936 13551 90089939
Immune reconstitution inflammatory syndrome 29.84 17.98 3 524954 7016 90096474
Drug use disorder 29.81 17.98 6 524951 8337 90095153
Appetite disorder 29.79 17.98 8 524949 9125 90094365
Respiratory tract infection 29.68 17.98 210 524747 58868 90044622
Interstitial lung disease 29.58 17.98 291 524666 76114 90027376
Secretion discharge 29.58 17.98 29 524928 15867 90087623
Vasculitis 29.41 17.98 54 524903 22639 90080851
Tuberculin test positive 29.37 17.98 66 524891 3659 90099831
Pulmonary thrombosis 29.32 17.98 10 524947 9772 90093718
Anaphylactic shock 29.21 17.98 90 524867 31527 90071963
Transplant rejection 29.10 17.98 19 524938 12739 90090751
Deafness neurosensory 28.89 17.98 3 524954 6838 90096652
Migraine 28.59 17.98 1363 523594 189029 89914461
Intestinal ischaemia 28.57 17.98 8 524949 8875 90094615
Rotator cuff syndrome 28.53 17.98 30 524927 15889 90087601
Intermenstrual bleeding 28.40 17.98 9 524948 9214 90094276
Anal abscess 28.33 17.98 85 524872 5623 90097867
Drug-induced liver injury 28.20 17.98 704 524253 89614 90013876
Visual field defect 28.15 17.98 4 524953 7162 90096328
Vitreous floaters 27.89 17.98 5 524952 7544 90095946
Gastric haemorrhage 27.82 17.98 4 524953 7099 90096391
Tension headache 27.68 17.98 5 524952 7504 90095986
White blood cell count abnormal 27.66 17.98 5 524952 7499 90095991
Necrosis 27.65 17.98 3 524954 6607 90096883
Abdominal distension 27.51 17.98 562 524395 130039 89973451
Bladder disorder 27.48 17.98 14 524943 10758 90092732
Staphylococcal infection 27.46 17.98 166 524791 48273 90055217
Dental caries 27.34 17.98 16 524941 11381 90092109
Large intestine perforation 27.31 17.98 11 524946 9701 90093789
Ventricular extrasystoles 27.26 17.98 22 524935 13228 90090262
Blood creatine increased 27.11 17.98 4 524953 6963 90096527
Facial paralysis 27.03 17.98 30 524927 15504 90087986
Eye injury 27.02 17.98 131 524826 10889 90092601
Dermatitis bullous 26.93 17.98 13 524944 10303 90093187
Pelvic fracture 26.92 17.98 29 524928 15190 90088300
Erythema multiforme 26.91 17.98 19 524938 12227 90091263
Congestive cardiomyopathy 26.89 17.98 5 524952 7349 90096141
Iron deficiency 26.84 17.98 11 524946 9601 90093889
Gingival bleeding 26.80 17.98 28 524929 14875 90088615
Pneumocystis jirovecii pneumonia 26.65 17.98 53 524904 21563 90081927
Ocular hyperaemia 26.63 17.98 103 524854 33695 90069795
Bunion operation 26.62 17.98 36 524921 1322 90102168
Unevaluable event 26.57 17.98 197 524760 54651 90048839
Infusion site reaction 26.43 17.98 195 524762 18844 90084646
Ear discomfort 26.40 17.98 13 524944 10187 90093303
Intracranial pressure increased 26.30 17.98 4 524953 6807 90096683
Ear pruritus 26.26 17.98 4 524953 6799 90096691
Muscle atrophy 26.22 17.98 8 524949 8393 90095097
Enterocolitis 26.21 17.98 14 524943 10476 90093014
Hypertensive crisis 26.14 17.98 39 524918 17745 90085745
Papule 26.12 17.98 7 524950 7995 90095495
Cholangitis 26.01 17.98 5 524952 7177 90096313
Breast pain 25.89 17.98 14 524943 10404 90093086
Hyperventilation 25.87 17.98 4 524953 6724 90096766
Non-cardiac chest pain 25.83 17.98 4 524953 6717 90096773
Injection site extravasation 25.71 17.98 10 524947 9009 90094481
Drug effective for unapproved indication 25.71 17.98 7 524950 7911 90095579
Injection site mass 25.69 17.98 56 524901 22034 90081456
Endocarditis 25.66 17.98 5 524952 7108 90096382
Tooth disorder 25.64 17.98 93 524864 30997 90072493
Diffuse large B-cell lymphoma 25.63 17.98 9 524948 8636 90094854
Localised oedema 25.44 17.98 3 524954 6191 90097299
Musculoskeletal discomfort 25.42 17.98 52 524905 20939 90082551
Atrial septal defect 25.41 17.98 8 524949 8226 90095264
Oedema 25.40 17.98 1411 523546 198884 89904606
Taste disorder 25.32 17.98 499 524458 61047 90042443
Activated partial thromboplastin time prolonged 25.25 17.98 7 524950 7818 90095672
Arteriosclerosis coronary artery 25.22 17.98 12 524945 9591 90093899
Skin mass 25.22 17.98 6 524951 7424 90096066
Malaise 24.99 17.98 2992 521965 582994 89520496
Lung opacity 24.95 17.98 3 524954 6099 90097391
Polyarthritis 24.94 17.98 187 524770 18163 90085327
Latent tuberculosis 24.90 17.98 54 524903 2922 90100568
Oropharyngeal discomfort 24.81 17.98 7 524950 7728 90095762
Pneumonia viral 24.80 17.98 10 524947 8813 90094677
Colitis ischaemic 24.78 17.98 21 524936 12325 90091165
Disability 24.74 17.98 352 524605 40393 90063097
Injection site induration 24.69 17.98 15 524942 10453 90093037
White blood cells urine positive 24.67 17.98 4 524953 6494 90096996
Disease susceptibility 24.57 17.98 17 524940 263 90103227
Faecaloma 24.52 17.98 15 524942 10416 90093074
Neurological symptom 24.31 17.98 5 524952 6842 90096648
Epilepsy 24.27 17.98 636 524321 81570 90021920
Groin pain 24.24 17.98 21 524936 12192 90091298
Myasthenia gravis 24.20 17.98 5 524952 6820 90096670
Thermal burn 23.88 17.98 5 524952 6757 90096733
Gastrointestinal pain 23.83 17.98 18 524939 11188 90092302
Ovarian hyperstimulation syndrome 23.68 17.98 3 524954 5859 90097631
Blood folate decreased 23.67 17.98 38 524919 1632 90101858
Dyspepsia 23.59 17.98 1388 523569 196772 89906718
Left ventricular failure 23.56 17.98 5 524952 6695 90096795
Hypovolaemic shock 23.55 17.98 6 524951 7088 90096402
Herpes simplex 23.44 17.98 15 524942 10166 90093324
Diabetic eye disease 23.41 17.98 14 524943 166 90103324
Nodule 23.35 17.98 247 524710 26439 90077051
Concussion 23.34 17.98 18 524939 11073 90092417
Phlebitis 23.33 17.98 7 524950 7423 90096067
Neutrophilia 23.23 17.98 3 524954 5775 90097715
Aortic valve incompetence 23.18 17.98 5 524952 6619 90096871
Eye movement disorder 23.12 17.98 4 524953 6194 90097296
Peroneal nerve palsy 23.08 17.98 3 524954 5745 90097745
Urine abnormality 23.03 17.98 8 524949 7729 90095761
Nephrotic syndrome 22.89 17.98 7 524950 7332 90096158
Mood swings 22.84 17.98 54 524903 20648 90082842
Cerebral disorder 22.79 17.98 3 524954 5691 90097799
Hyperkeratosis 22.73 17.98 6 524951 6922 90096568
Enteritis 22.70 17.98 16 524941 10305 90093185
Arthritis 22.67 17.98 1186 523771 166129 89937361
Paronychia 22.62 17.98 9 524948 7997 90095493
Hydrocephalus 22.59 17.98 4 524953 6090 90097400
Device failure 22.58 17.98 6 524951 6891 90096599
Pathological fracture 22.56 17.98 14 524943 9646 90093844
Cardiac failure chronic 22.54 17.98 3 524954 5643 90097847
Autoimmune haemolytic anaemia 22.53 17.98 3 524954 5642 90097848
Tuberculosis 22.52 17.98 137 524820 12412 90091078
Skin reaction 22.42 17.98 184 524773 18369 90085121
Dry throat 22.41 17.98 9 524948 7951 90095539
Skin hyperpigmentation 22.35 17.98 6 524951 6845 90096645
Tooth fracture 22.29 17.98 24 524933 12576 90090914
Flank pain 22.13 17.98 49 524908 19173 90084317
Vitamin D decreased 22.12 17.98 22 524935 11957 90091533
Scratch 22.09 17.98 15 524942 9851 90093639
Neoplasm 22.08 17.98 12 524945 8891 90094599
Coronary artery occlusion 21.99 17.98 11 524946 8543 90094947
Fibrosis 21.86 17.98 4 524953 5948 90097542
Skin irritation 21.83 17.98 28 524929 13575 90089915
Psychiatric symptom 21.82 17.98 7 524950 7111 90096379
Dermatitis contact 21.80 17.98 28 524929 13567 90089923
Lung neoplasm 21.78 17.98 6 524951 6729 90096761
Exposure during pregnancy 21.78 17.98 1633 523324 236777 89866713
Humerus fracture 21.74 17.98 15 524942 9770 90093720
Basal cell carcinoma 21.71 17.98 292 524665 33097 90070393
Exposure via breast milk 21.69 17.98 44 524913 2271 90101219
Muscle disorder 21.66 17.98 3 524954 5476 90098014
Grip strength 21.57 17.98 106 524851 8859 90094631
Tongue oedema 21.53 17.98 3 524954 5451 90098039
Contraindication to medical treatment 21.47 17.98 27 524930 922 90102568
Renal pain 21.47 17.98 9 524948 7750 90095740
Product storage error 21.45 17.98 195 524762 20046 90083444
Scleroderma 21.36 17.98 5 524952 6256 90097234
Blood pressure diastolic increased 21.30 17.98 26 524931 12880 90090610
Injection site pruritus 21.28 17.98 204 524753 53630 90049860
Clostridium test positive 21.25 17.98 3 524954 5398 90098092
Eye disorder 21.24 17.98 84 524873 27306 90076184
Escherichia sepsis 21.17 17.98 4 524953 5812 90097678
Therapeutic response shortened 21.08 17.98 214 524743 22665 90080825
Azotaemia 20.98 17.98 3 524954 5345 90098145
Osteoporosis 20.96 17.98 719 524238 95812 90007678
Cyst 20.94 17.98 40 524917 16521 90086969
Spinal disorder 20.94 17.98 22 524935 11657 90091833
Left ventricular hypertrophy 20.78 17.98 5 524952 6139 90097351
Metastasis 20.74 17.98 5 524952 6132 90097358
Systemic inflammatory response syndrome 20.71 17.98 6 524951 6510 90096980
Subcutaneous drug absorption impaired 20.71 17.98 142 524815 13403 90090087
Laryngeal oedema 20.68 17.98 7 524950 6874 90096616
Eye discharge 20.67 17.98 11 524946 8247 90095243
Depressive symptom 20.65 17.98 3 524954 5282 90098208
Pyrexia 20.61 17.98 3437 521520 657048 89446442
Frustration tolerance decreased 20.54 17.98 10 524947 7886 90095604
Acne 20.51 17.98 90 524867 28417 90075073
Anaphylactic reaction 20.46 17.98 370 524587 87154 90016336
Hepatic lesion 20.44 17.98 4 524953 5669 90097821
Post-traumatic stress disorder 20.43 17.98 7 524950 6821 90096669
Laboratory test abnormal 20.43 17.98 150 524807 41704 90061786
Hepatitis C 20.37 17.98 4 524953 5656 90097834
Abortion 20.36 17.98 48 524909 2747 90100743
Prolonged pregnancy 20.33 17.98 11 524946 106 90103384
Colon cancer 20.32 17.98 20 524937 10924 90092566
Periorbital oedema 20.29 17.98 7 524950 6792 90096698
Application site erythema 20.24 17.98 3 524954 5205 90098285
Extra dose administered 20.23 17.98 14 524943 9104 90094386
Hypertension 20.18 17.98 2983 521974 454549 89648941
Spinal fusion surgery 20.12 17.98 131 524826 12152 90091338
Fine motor skill dysfunction 20.00 17.98 73 524884 5346 90098144
Porphyria acute 19.99 17.98 175 524782 17800 90085690
Dermatitis acneiform 19.92 17.98 6 524951 6348 90097142
Hyperuricaemia 19.91 17.98 7 524950 6712 90096778
Odynophagia 19.91 17.98 14 524943 9029 90094461
Gingival pain 19.89 17.98 16 524941 9636 90093854
Rhinovirus infection 19.88 17.98 5 524952 5958 90097532
Dermatitis exfoliative 19.74 17.98 4 524953 5532 90097958
Muscle spasms 19.74 17.98 1226 523731 250657 89852833
Hepatic enzyme 19.74 17.98 72 524885 5272 90098218
Abnormal faeces 19.74 17.98 7 524950 6675 90096815
Overweight 19.73 17.98 5 524952 5929 90097561
Product prescribing issue 19.67 17.98 95 524862 7884 90095606
Bipolar disorder 19.66 17.98 14 524943 8971 90094519
Respiratory syncytial virus infection 19.64 17.98 19 524938 10461 90093029
Escherichia urinary tract infection 19.63 17.98 31 524926 13784 90089706
Injection site erythema 19.53 17.98 428 524529 98074 90005416
Spinal osteoarthritis 19.53 17.98 52 524905 19096 90084394
Pregnancy with contraceptive device 19.50 17.98 3 524954 5063 90098427
Varicose vein 19.48 17.98 9 524948 7318 90096172
Peptic ulcer 19.43 17.98 4 524953 5471 90098019
Musculoskeletal disorder 19.29 17.98 202 524755 21567 90081923
Photopsia 19.29 17.98 3 524954 5021 90098469
Wrong technique in device usage process 19.25 17.98 5 524952 5830 90097660
Gingival swelling 19.23 17.98 3 524954 5010 90098480
Hepatic cyst 19.20 17.98 7 524950 6561 90096929
Wound dehiscence 19.18 17.98 5 524952 5817 90097673
Leukaemia 19.12 17.98 3 524954 4989 90098501
Product quality issue 19.07 17.98 598 524359 78727 90024763
Incoherent 19.04 17.98 3 524954 4974 90098516
Circumstance or information capable of leading to medication error 18.99 17.98 3 524954 4964 90098526
Borrelia infection 18.94 17.98 15 524942 288 90103202
Retinal haemorrhage 18.90 17.98 5 524952 5759 90097731
Post procedural haemorrhage 18.88 17.98 14 524943 8784 90094706
Pneumonia bacterial 18.84 17.98 28 524929 12762 90090728
Nerve compression 18.84 17.98 20 524937 10546 90092944
Vitamin B12 deficiency 18.69 17.98 10 524947 7476 90096014
Decreased immune responsiveness 18.67 17.98 14 524943 8734 90094756
Fear of injection 18.61 17.98 98 524859 8417 90095073
Vitamin B12 decreased 18.60 17.98 4 524953 5306 90098184
Hepatic cancer 18.54 17.98 3 524954 4878 90098612
Pharyngeal oedema 18.54 17.98 32 524925 13739 90089751
Multiple-drug resistance 18.54 17.98 11 524946 7765 90095725
Urosepsis 18.52 17.98 62 524895 21170 90082320
Polycystic ovaries 18.35 17.98 5 524952 5649 90097841
Catheter site infection 18.35 17.98 5 524952 5649 90097841
Parosmia 18.31 17.98 9 524948 7060 90096430
Metastatic neoplasm 18.20 17.98 3 524954 4812 90098678
Periorbital swelling 18.11 17.98 3 524954 4795 90098695
Glucose tolerance impaired 18.06 17.98 12 524945 7973 90095517
Thrombocytosis 18.01 17.98 9 524948 6992 90096498

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
Drug ineffective 1468.65 18.43 2196 34212 628001 41956926
Therapy interrupted 663.94 18.43 341 36067 21909 42563018
Product dose omission issue 661.25 18.43 733 35675 153632 42431295
Synovitis 602.81 18.43 285 36123 15282 42569645
Treatment failure 551.21 18.43 444 35964 62180 42522747
Product availability issue 501.05 18.43 166 36242 3401 42581526
No adverse event 493.60 18.43 344 36064 38677 42546250
Insurance issue 401.83 18.43 146 36262 3970 42580957
Rheumatoid arthritis 366.96 18.43 298 36110 42142 42542785
Maternal exposure before pregnancy 360.55 18.43 98 36310 979 42583948
Maternal exposure during pregnancy 353.03 18.43 154 36254 6824 42578103
Joint swelling 345.00 18.43 354 36054 67668 42517259
Pain 337.55 18.43 683 35725 244165 42340762
Therapeutic product effect decreased 326.04 18.43 269 36139 38881 42546046
Loss of personal independence in daily activities 242.96 18.43 254 36154 49562 42535365
Psoriasis 242.75 18.43 251 36157 48353 42536574
Contraindicated product administered 240.86 18.43 188 36220 25084 42559843
Arthropathy 239.35 18.43 200 36208 29397 42555530
C-reactive protein abnormal 230.88 18.43 126 36282 9135 42575792
Drug hypersensitivity 217.54 18.43 340 36068 99049 42485878
Red blood cell sedimentation rate abnormal 214.87 18.43 91 36317 3745 42581182
Arthralgia 213.61 18.43 512 35896 204726 42380201
Drug intolerance 211.65 18.43 300 36108 80124 42504803
Psoriatic arthropathy 208.69 18.43 172 36236 24795 42560132
Tenosynovitis 197.21 18.43 91 36317 4604 42580323
Musculoskeletal stiffness 191.07 18.43 241 36167 57524 42527403
Enthesopathy 188.61 18.43 89 36319 4739 42580188
Alanine aminotransferase abnormal 174.49 18.43 85 36323 4859 42580068
Toxicity to various agents 169.32 18.43 6 36402 229130 42355797
Drug interaction 167.55 18.43 17 36391 266982 42317945
Acute kidney injury 167.47 18.43 53 36355 367284 42217643
Ankylosing spondylitis 159.44 18.43 90 36318 6966 42577961
Bone erosion 150.30 18.43 74 36334 4329 42580598
Surgery 142.28 18.43 119 36289 17497 42567430
Tongue disorder 133.49 18.43 73 36335 5310 42579617
Hypotension 132.80 18.43 29 36379 257602 42327325
Intentional dose omission 127.15 18.43 85 36323 8901 42576026
COVID-19 immunisation 123.73 18.43 28 36380 118 42584809
Exposure via breast milk 123.09 18.43 54 36354 2423 42582504
Neutropenia 119.24 18.43 15 36393 199416 42385511
Infection 114.56 18.43 278 36130 111790 42473137
Therapeutic product effect incomplete 109.42 18.43 208 36200 70731 42514196
Arthritis 100.46 18.43 150 36258 41915 42543012
Confusional state 99.21 18.43 13 36395 167584 42417343
Low birth weight baby 96.84 18.43 75 36333 9880 42575047
Anaemia 96.83 18.43 60 36348 280218 42304709
Knee arthroplasty 96.14 18.43 71 36337 8710 42576217
Anti-cyclic citrullinated peptide antibody positive 96.03 18.43 42 36366 1870 42583057
Cytology abnormal 96 18.43 28 36380 368 42584559
Rheumatoid factor negative 95.35 18.43 35 36373 979 42583948
Tendonitis 95.07 18.43 74 36334 9820 42575107
Thrombocytopenia 94.83 18.43 23 36385 190256 42394671
C-reactive protein increased 93.88 18.43 183 36225 63377 42521550
Premature baby 93.53 18.43 107 36301 23046 42561881
Hypersensitivity 93.39 18.43 197 36211 72173 42512754
Injection site pain 89.76 18.43 170 36238 57628 42527299
Gastric disorder 89.02 18.43 77 36331 11845 42573082
Mobility decreased 88.77 18.43 129 36279 35177 42549750
Disease progression 87.82 18.43 10 36398 143646 42441281
Inflammation 85.58 18.43 124 36284 33723 42551204
Pancytopenia 83.81 18.43 4 36404 117739 42467188
Drug tolerance decreased 81.55 18.43 40 36368 2320 42582607
Polyarthritis 81.29 18.43 52 36356 5052 42579875
Renal failure 80.75 18.43 13 36395 143713 42441214
Physical disability 77.70 18.43 36 36372 1837 42583090
Seronegative arthritis 75.13 18.43 31 36377 1193 42583734
Joint lock 74.72 18.43 32 36376 1353 42583574
Product distribution issue 72.52 18.43 35 36373 1959 42582968
Nasopharyngitis 68.93 18.43 192 36216 83804 42501123
Drug abuse 67.38 18.43 6 36402 104765 42480162
Frequent bowel movements 67.05 18.43 87 36321 21320 42563607
Hand deformity 64.03 18.43 40 36368 3728 42581199
Prerenal failure 63.12 18.43 34 36374 2399 42582528
Completed suicide 60.76 18.43 6 36402 96459 42488468
Injection site reaction 60.71 18.43 71 36337 15650 42569277
Bone cyst 60.10 18.43 29 36379 1622 42583305
Fine motor skill dysfunction 60.08 18.43 32 36376 2207 42582720
Joint ankylosis 59.67 18.43 29 36379 1648 42583279
Tuberculosis 59.29 18.43 57 36351 10042 42574885
Rash 59.28 18.43 422 35986 276532 42308395
Inappropriate schedule of product administration 58.84 18.43 198 36210 95704 42489223
White blood cell count decreased 57.66 18.43 12 36396 110384 42474543
Renal impairment 57.53 18.43 12 36396 110216 42474711
Hyponatraemia 55.16 18.43 10 36398 101452 42483475
Red blood cell sedimentation rate 55.14 18.43 24 36384 1056 42583871
Skin mass 55.11 18.43 40 36368 4776 42580151
Dyspnoea 55.11 18.43 194 36214 442427 42142500
Peripheral swelling 55.05 18.43 186 36222 90084 42494843
Joint stiffness 54.99 18.43 60 36348 12262 42572665
Granuloma skin 53.20 18.43 24 36384 1151 42583776
Pustular psoriasis 53.14 18.43 29 36379 2100 42582827
Axial spondyloarthritis 51.94 18.43 19 36389 526 42584401
Constipation 51.59 18.43 38 36370 162253 42422674
Tachycardia 50.74 18.43 12 36396 101075 42483852
Blood creatinine increased 49.73 18.43 16 36392 109987 42474940
Cardiac arrest 49.24 18.43 16 36392 109304 42475623
Sinusitis 48.97 18.43 118 36290 47174 42537753
Abdominal abscess 48.72 18.43 38 36370 5055 42579872
Latent tuberculosis 48.10 18.43 25 36383 1640 42583287
Herpes zoster 48 18.43 104 36304 38773 42546154
Sarcoidosis 47.73 18.43 33 36375 3649 42581278
Somnolence 47.55 18.43 31 36377 141074 42443853
Product use in unapproved indication 46.97 18.43 53 36355 184403 42400524
Rhabdomyolysis 46.25 18.43 6 36402 78013 42506914
Blood parathyroid hormone decreased 45.55 18.43 24 36384 1619 42583308
Gastrointestinal infection 45.25 18.43 41 36367 6702 42578225
Skin injury 44.79 18.43 28 36380 2613 42582314
Abdominal pain 44.69 18.43 297 36111 190174 42394753
Off label use 43.84 18.43 776 35632 637559 41947368
Respiratory failure 43.37 18.43 28 36380 128104 42456823
Seizure 42.68 18.43 25 36383 120536 42464391
Multiple organ dysfunction syndrome 42.31 18.43 15 36393 97020 42487907
Therapeutic response shortened 42.31 18.43 55 36353 13499 42571428
Inflammatory bowel disease 41.96 18.43 30 36378 3499 42581428
Panniculitis 41.79 18.43 25 36383 2156 42582771
Ill-defined disorder 41.61 18.43 60 36348 16236 42568691
Osteolysis 41.57 18.43 30 36378 3550 42581377
Nephrolithiasis 41.50 18.43 95 36313 36735 42548192
Neck mass 40.18 18.43 23 36385 1827 42583100
Overdose 39.92 18.43 20 36388 105244 42479683
Decreased appetite 39.58 18.43 65 36343 193072 42391855
Injection site bruising 39.50 18.43 49 36359 11476 42573451
Bradycardia 39.40 18.43 12 36396 85472 42499455
Crohn's disease 39.28 18.43 27 36381 2957 42581970
Upper respiratory tract infection 39.21 18.43 101 36307 42072 42542855
Hypokalaemia 39.12 18.43 7 36401 71714 42513213
Mycobacterium tuberculosis complex test positive 38.55 18.43 21 36387 1515 42583412
Localised infection 38.09 18.43 65 36343 20308 42564619
Mass 38.03 18.43 42 36366 8697 42576230
Septic shock 36.95 18.43 16 36392 91656 42493271
Asthenia 36.95 18.43 120 36288 280673 42304254
Skin ulcer 36.90 18.43 73 36335 25528 42559399
Rheumatoid nodule 36.85 18.43 26 36382 2969 42581958
Contraindication to medical treatment 36.81 18.43 17 36391 861 42584066
Musculoskeletal pain 36.47 18.43 85 36323 33255 42551672
Gastrointestinal haemorrhage 36.41 18.43 19 36389 97707 42487220
Platelet count decreased 36.16 18.43 39 36369 138542 42446385
Syncope 36.05 18.43 20 36388 99386 42485541
Oxygen saturation decreased 35.97 18.43 6 36402 64681 42520246
Immobilisation syndrome 35.96 18.43 14 36394 462 42584465
Disability 35.80 18.43 34 36374 5899 42579028
Prostate cancer 35.56 18.43 101 36307 44542 42540385
Basal cell carcinoma 35.43 18.43 67 36341 22666 42562261
Palmoplantar pustulosis 35.42 18.43 14 36394 481 42584446
Hallucination 35.12 18.43 4 36404 57503 42527424
Vomiting 34.63 18.43 129 36279 289594 42295333
Fistula 34.39 18.43 38 36370 7874 42577053
Swelling 34.24 18.43 114 36294 54771 42530156
Erythema 34.05 18.43 183 36225 108610 42476317
Agitation 33.55 18.43 7 36401 64307 42520620
Illness 33.44 18.43 69 36339 24861 42560066
Foetal exposure during pregnancy 32.90 18.43 102 36306 47209 42537718
Oedema peripheral 32.59 18.43 41 36367 136035 42448892
Hypoglycaemia 32.30 18.43 6 36402 59848 42525079
Skin laceration 31.93 18.43 49 36359 14009 42570918
Hypoxia 31.79 18.43 10 36398 69776 42515151
Tremor 31.69 18.43 22 36386 96907 42488020
Chondropathy 31.51 18.43 17 36391 1203 42583724
Hepatic fibrosis 31.47 18.43 29 36379 4843 42580084
Product storage error 31.39 18.43 43 36365 11097 42573830
Cardio-respiratory arrest 31.38 18.43 6 36402 58630 42526297
Needle issue 31.36 18.43 38 36370 8689 42576238
Hip arthroplasty 31.24 18.43 30 36378 5275 42579652
Headache 31.22 18.43 327 36081 239042 42345885
Limb discomfort 31.13 18.43 46 36362 12721 42572206
Haematuria 30.75 18.43 6 36402 57793 42527134
Pruritus 30.59 18.43 270 36138 188501 42396426
Rheumatoid factor increased 30.44 18.43 14 36394 702 42584225
Testicular seminoma (pure) 30.44 18.43 10 36398 199 42584728
Death 30.05 18.43 258 36150 470927 42114000
Rheumatoid factor 29.98 18.43 8 36400 74 42584853
Sepsis 29.96 18.43 80 36328 199254 42385673
Delirium 28.91 18.43 5 36403 52514 42532413
Hospitalisation 28.90 18.43 133 36275 74197 42510730
Sacroiliitis 28.64 18.43 19 36389 1963 42582964
Rectal abscess 28.62 18.43 18 36390 1697 42583230
Skin necrosis 28.62 18.43 31 36377 6283 42578644
Body mass index abnormal 28.03 18.43 9 36399 166 42584761
Blood creatine phosphokinase increased 27.97 18.43 4 36404 48334 42536593
Ascites 27.90 18.43 7 36401 56671 42528256
Therapeutic response decreased 27.80 18.43 82 36326 36930 42547997
Maternal exposure during breast feeding 27.67 18.43 17 36391 1538 42583389
Bronchitis 27.64 18.43 96 36312 47105 42537822
Injection site rash 27.57 18.43 29 36379 5683 42579244
Plasma cell myeloma 27.39 18.43 4 36404 47574 42537353
Dysphagia 27.29 18.43 14 36394 72705 42512222
Cardiac failure congestive 27.23 18.43 20 36388 85582 42499345
Spondyloarthropathy 27.20 18.43 14 36394 900 42584027
Motor dysfunction 26.91 18.43 34 36374 8112 42576815
Joint range of motion decreased 26.63 18.43 33 36375 7720 42577207
Folliculitis 26.44 18.43 28 36380 5530 42579397
Loss of consciousness 26.37 18.43 24 36384 92330 42492597
Hyperglycaemia 26.06 18.43 4 36404 45855 42539072
Seminoma 26.03 18.43 10 36398 318 42584609
Dyspepsia 25.88 18.43 86 36322 41266 42543661
Bladder transitional cell carcinoma 25.67 18.43 20 36388 2656 42582271
International normalised ratio increased 25.63 18.43 5 36403 48163 42536764
Rheumatoid factor positive 25.59 18.43 13 36395 813 42584114
Pulmonary oedema 25.42 18.43 7 36401 53265 42531662
Ligament calcification 25.21 18.43 9 36399 232 42584695
Bradycardia foetal 24.97 18.43 10 36398 356 42584571
Injection site erythema 24.89 18.43 54 36354 20141 42564786
Cellulitis 24.54 18.43 111 36297 61474 42523453
Oedema 24.51 18.43 7 36401 51994 42532933
Impaired work ability 24.50 18.43 40 36368 12051 42572876
Leukopenia 24.38 18.43 17 36391 74729 42510198
Hepatic function abnormal 24.19 18.43 7 36401 51560 42533367
Anxiety 24.17 18.43 40 36368 118520 42466407
Haemoglobin decreased 24.05 18.43 48 36360 132423 42452504
Knee operation 23.96 18.43 19 36389 2589 42582338
Anal fistula 23.88 18.43 28 36380 6185 42578742
Hepatic steatosis 23.80 18.43 55 36353 21393 42563534
Fungal skin infection 23.77 18.43 21 36387 3320 42581607
Fear of injection 23.75 18.43 17 36391 1986 42582941
Dysarthria 23.73 18.43 3 36405 39804 42545123
Cerebrovascular accident 23.54 18.43 29 36379 97131 42487796
Abscess 23.46 18.43 43 36365 14205 42570722
Tooth extraction 23.27 18.43 26 36382 5454 42579473
Respiratory distress 22.98 18.43 4 36404 41816 42543111
Wheezing 22.98 18.43 9 36399 54772 42530155
Quarantine 22.94 18.43 5 36403 17 42584910
Dermatitis psoriasiform 22.87 18.43 17 36391 2105 42582822
Perirectal abscess 22.72 18.43 16 36392 1822 42583105
Lethargy 22.68 18.43 6 36402 46884 42538043
Acute myocardial infarction 22.12 18.43 11 36397 58154 42526773
Anal abscess 21.66 18.43 30 36378 7820 42577107
Fall 21.60 18.43 115 36293 234405 42350522
Tonsil cancer 21.45 18.43 13 36395 1148 42583779
Spinal operation 21.40 18.43 22 36386 4198 42580729
Balance disorder 21.39 18.43 7 36401 47638 42537289
Pharyngitis streptococcal 21.00 18.43 21 36387 3879 42581048
Urticaria 20.79 18.43 121 36287 73915 42511012
Metastatic bronchial carcinoma 20.76 18.43 9 36399 392 42584535
Melaena 20.66 18.43 4 36404 38742 42546185
Limb operation 20.61 18.43 12 36396 984 42583943
Bronchial dysplasia 20.35 18.43 5 36403 32 42584895
Hepatic failure 20.17 18.43 4 36404 38096 42546831
Intentional product use issue 20.11 18.43 19 36389 71814 42513113
Adverse drug reaction 20.09 18.43 74 36334 37360 42547567
Injection site haemorrhage 20.06 18.43 36 36372 11700 42573227
Tooth fracture 19.77 18.43 21 36387 4163 42580764
Pneumonia aspiration 19.76 18.43 9 36399 50069 42534858
Foot deformity 19.75 18.43 23 36385 5045 42579882
Neonatal infection 19.63 18.43 9 36399 448 42584479
Atrial fibrillation 19.49 18.43 58 36350 139535 42445392
Metabolic acidosis 19.43 18.43 10 36398 51848 42533079
Mental status changes 19.24 18.43 6 36402 42109 42542818
Osteoarthritis 19.22 18.43 55 36353 24350 42560577
Dehydration 19.02 18.43 60 36348 141707 42443220
Cerebral haemorrhage 18.82 18.43 5 36403 38961 42545966
Rheumatoid lung 18.77 18.43 11 36397 913 42584014

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
Synovitis 2957.96 22.42 4223 388908 269869 109926299
Hand deformity 2667.78 22.42 3574 389557 214932 109981236
Pemphigus 2617.06 22.42 3508 389623 211062 109985106
Systemic lupus erythematosus 2553.49 22.42 3788 389343 250550 109945618
Glossodynia 2502.87 22.42 3494 389637 218510 109977658
Contraindicated product administered 2411.27 22.42 3641 389490 244626 109951542
Anti-cyclic citrullinated peptide antibody positive 2358.76 22.42 3066 390065 178918 110017250
Arthropathy 2219.25 22.42 3798 389333 283724 109912444
Joint swelling 2196.33 22.42 4851 388280 437994 109758174
Swelling 2037.74 22.42 4102 389029 346939 109849229
Maternal exposure during pregnancy 2019.51 22.42 3407 389724 251476 109944692
Pericarditis 2013.62 22.42 3133 389998 215981 109980187
Therapeutic product effect decreased 1971.84 22.42 3293 389838 241023 109955145
Wound 1952.59 22.42 3205 389926 231232 109964936
Drug intolerance 1940.80 22.42 4387 388744 402125 109794043
Acute kidney injury 1914.35 22.42 81 393050 635349 109560819
Alopecia 1839.31 22.42 4024 389107 360729 109835439
Helicobacter infection 1782.58 22.42 2680 390451 179197 110016971
Duodenal ulcer perforation 1772.36 22.42 2640 390491 175060 110021108
Drug interaction 1654.69 22.42 24 393107 500159 109696009
Abdominal discomfort 1634.21 22.42 4025 389106 389833 109806335
Folliculitis 1618.02 22.42 2453 390678 165200 110030968
Hypersensitivity 1588.50 22.42 4045 389086 399953 109796215
Toxicity to various agents 1510.52 22.42 43 393088 480512 109715656
Irritable bowel syndrome 1475.73 22.42 2325 390806 161890 110034278
Anaemia 1437.97 22.42 141 392990 546945 109649223
Rheumatoid factor positive 1434.64 22.42 2040 391091 129600 110066568
Hepatic enzyme increased 1428.70 22.42 3371 389760 317521 109878647
Muscle injury 1407.99 22.42 2095 391036 138712 110057456
Drug ineffective 1384.54 22.42 9672 383459 1510868 108685300
Discomfort 1316.36 22.42 2569 390562 212138 109984030
Impaired healing 1309.85 22.42 2438 390693 194279 110001889
Hypotension 1277.02 22.42 175 392956 523674 109672494
Treatment failure 1276.98 22.42 2952 390179 274282 109921886
Blister 1258.30 22.42 2607 390524 224769 109971399
Sleep disorder due to general medical condition, insomnia type 1241.76 22.42 1698 391433 103945 110092223
Psoriatic arthropathy 1212.99 22.42 2360 390771 194401 110001767
Lower respiratory tract infection 1121.89 22.42 2591 390540 240515 109955653
Ill-defined disorder 1085.47 22.42 1977 391154 154876 110041292
Febrile neutropenia 1075.19 22.42 9 393122 316758 109879410
Rheumatic fever 1054.74 22.42 1702 391429 120877 110075291
Neutropenia 1017.59 22.42 84 393047 374536 109821632
Infusion related reaction 979.42 22.42 3280 389851 377882 109818286
Rheumatoid arthritis 908.23 22.42 2730 390401 296883 109899285
Fibromyalgia 884.01 22.42 1907 391224 169002 110027166
C-reactive protein abnormal 879.84 22.42 1621 391510 128074 110068094
Death 871.67 22.42 724 392407 698145 109498023
Type 2 diabetes mellitus 867.32 22.42 1934 391197 175298 110020870
Sinusitis 862.41 22.42 2664 390467 294024 109902144
Musculoskeletal stiffness 856.85 22.42 2559 390572 277263 109918905
Constipation 844.77 22.42 131 393000 357655 109838513
Stomatitis 838.46 22.42 2483 390648 267759 109928409
Maternal exposure before pregnancy 836.45 22.42 441 392690 6824 110189344
Completed suicide 817.13 22.42 8 393123 242373 109953795
Mobility decreased 810.60 22.42 2258 390873 235164 109961004
Infection 782.63 22.42 2945 390186 359255 109836913
Thrombocytopenia 781.27 22.42 147 392984 348738 109847430
Swollen joint count increased 762.66 22.42 1193 391938 82468 110113700
Facet joint syndrome 732.00 22.42 1269 391862 95559 110100609
Pain 712.63 22.42 5807 387324 949148 109247020
Peripheral swelling 711.67 22.42 3083 390048 400951 109795217
Disease progression 711.52 22.42 38 393093 243996 109952172
Gastrointestinal disorder 705.12 22.42 2175 390956 239777 109956391
Hyponatraemia 704.29 22.42 14 393117 217639 109978529
Fall 669.64 22.42 695 392436 602787 109593381
Blood cholesterol increased 665.94 22.42 1793 391338 182992 110013176
Somnolence 658.11 22.42 129 393002 297320 109898848
Renal failure 643.10 22.42 41 393090 226533 109969635
Pancytopenia 642.82 22.42 23 393108 209590 109986578
Sepsis 623.33 22.42 194 392937 327152 109869016
Rash 621.95 22.42 5011 388120 815953 109380215
Lip dry 616.82 22.42 1201 391930 98882 110097286
Arthralgia 615.30 22.42 4804 388327 774828 109421340
Dehydration 614.62 22.42 123 393008 279388 109916780
Cardiac arrest 612.51 22.42 19 393112 196734 109999434
Cough 611.95 22.42 449 392682 461192 109734976
Therapy interrupted 600.55 22.42 811 392320 49011 110147157
Joint range of motion decreased 589.61 22.42 1324 391807 120508 110075660
Nasopharyngitis 585.21 22.42 2862 390269 391499 109804669
Seizure 572.58 22.42 60 393071 221125 109975043
Haemoglobin decreased 571.41 22.42 98 393033 248629 109947539
Night sweats 564.32 22.42 1379 391752 132604 110063564
Liver injury 560.58 22.42 1478 391653 148935 110047233
Injury 551.49 22.42 1631 391500 175634 110020534
Inflammation 549.74 22.42 1723 391408 191515 110004653
Bursitis 545.93 22.42 1336 391795 128582 110067586
Respiratory failure 540.81 22.42 65 393066 215267 109980901
Renal impairment 535.07 22.42 34 393097 188411 110007757
Grip strength decreased 523.40 22.42 986 392145 79188 110116980
Pulmonary embolism 511.79 22.42 76 393055 214398 109981770
Tremor 498.24 22.42 65 393066 202167 109994001
Product use issue 489.59 22.42 2300 390831 309395 109886773
Bradycardia 480.53 22.42 16 393115 155501 110040667
Gastrointestinal haemorrhage 478.60 22.42 27 393104 165491 110030677
Platelet count decreased 469.32 22.42 120 393011 230323 109965845
Oxygen saturation decreased 468.54 22.42 21 393110 156961 110039207
Breast cancer stage III 467.61 22.42 933 392198 78184 110117984
Hyperkalaemia 464.79 22.42 3 393128 135793 110060375
Product availability issue 451.00 22.42 305 392826 7585 110188583
Multiple organ dysfunction syndrome 450.49 22.42 21 393110 151689 110044479
Intentional overdose 443.57 22.42 5 393126 132496 110063672
Maternal exposure during breast feeding 442.28 22.42 241 392890 3997 110192171
Peripheral venous disease 438.48 22.42 942 392189 83175 110112993
Syncope 431.06 22.42 96 393035 202440 109993728
Cardiac failure 430.73 22.42 74 393057 187552 110008616
Hypercholesterolaemia 422.57 22.42 972 392159 89865 110106303
Adverse event 421.52 22.42 1085 392046 107724 110088444
Hip arthroplasty 421.06 22.42 731 392400 55082 110141086
Pregnancy 419.88 22.42 695 392436 50372 110145796
Urticaria 415.42 22.42 2232 390899 316625 109879543
Neutrophil count decreased 412.27 22.42 3 393128 120938 110075230
Cardiac failure congestive 412.07 22.42 33 393098 150967 110045201
Deep vein thrombosis postoperative 405.51 22.42 744 392387 58547 110137621
Knee arthroplasty 400.83 22.42 780 392351 64168 110132000
Sciatica 400.72 22.42 962 392169 91437 110104731
White blood cell count decreased 393.80 22.42 161 392970 229229 109966939
Hypoxia 384.31 22.42 18 393113 129497 110066671
Neuropathy peripheral 383.48 22.42 84 393047 179193 110016975
Insurance issue 380.76 22.42 310 392821 10302 110185866
Rhabdomyolysis 380.67 22.42 10 393121 120391 110075777
Cardio-respiratory arrest 380.62 22.42 6 393125 115830 110080338
Dysphagia 379.21 22.42 49 393082 153551 110042617
Contusion 378.76 22.42 1739 391392 231622 109964546
Gait inability 376.70 22.42 1204 391927 135172 110060996
Blood creatinine increased 376.70 22.42 93 393038 182796 110013372
Drug hypersensitivity 376.63 22.42 2833 390298 451257 109744911
Lower limb fracture 375.84 22.42 829 392302 74519 110121649
Cerebrovascular accident 375.70 22.42 91 393040 181193 110014975
Depressed level of consciousness 372.43 22.42 5 393126 112273 110083895
Coma 371.87 22.42 10 393121 117859 110078309
Obesity 370.69 22.42 1062 392069 112289 110083879
Bone erosion 370.42 22.42 623 392508 45748 110150420
Wound infection 363.45 22.42 952 392179 95513 110100655
Hypoglycaemia 362.07 22.42 11 393120 116093 110080075
Nail disorder 359.00 22.42 697 392434 57238 110138930
Autoimmune disorder 358.26 22.42 748 392383 64735 110131433
Electrocardiogram QT prolonged 356.52 22.42 6 393125 108954 110087214
Hypokalaemia 356.43 22.42 103 393028 182345 110013823
Osteoarthritis 356.38 22.42 1439 391692 181184 110014984
Dyspnoea 348.79 22.42 2405 390726 1104467 109091701
Myalgia 347.63 22.42 178 392953 222203 109973965
Hyperhidrosis 340.58 22.42 120 393011 187178 110008990
Sleep disorder 340.07 22.42 1504 391627 197140 109999028
Agitation 337.75 22.42 15 393116 113036 110083132
Foot deformity 336.15 22.42 612 392519 47868 110148300
Chest discomfort 334.40 22.42 101 393030 173747 110022421
C-reactive protein increased 328.81 22.42 1590 391541 216329 109979839
Atrial fibrillation 321.69 22.42 210 392921 229432 109966736
Loss of personal independence in daily activities 320.16 22.42 1216 391915 148804 110047364
Live birth 319.27 22.42 740 392391 68744 110127424
Onychomadesis 318.59 22.42 578 392553 45085 110151083
Metabolic acidosis 309.05 22.42 10 393121 99734 110096434
Tachycardia 308.43 22.42 214 392917 226431 109969737
Hallucination 307.90 22.42 12 393119 101420 110094748
Musculoskeletal pain 305.17 22.42 1375 391756 181648 110014520
General physical health deterioration 299.94 22.42 2557 390574 422738 109773430
Suicide attempt 295.41 22.42 18 393113 103376 110092792
Overdose 293.44 22.42 240 392891 233554 109962614
Onychomycosis 292.36 22.42 506 392625 38025 110158143
Blood pressure increased 291.21 22.42 293 392838 258080 109938088
Road traffic accident 290.04 22.42 941 392190 106457 110089711
Epistaxis 289.32 22.42 56 393075 130316 110065852
Deep vein thrombosis 288.31 22.42 71 393060 139816 110056352
Weight increased 284.40 22.42 2501 390630 417143 109779025
Balance disorder 278.69 22.42 41 393090 116519 110079649
Adjustment disorder with depressed mood 278.06 22.42 533 392598 43350 110152818
Pulmonary oedema 277.43 22.42 21 393110 100638 110095530
Chills 275.56 22.42 168 392963 190412 110005756
Hypoaesthesia 275.42 22.42 1987 391144 312236 109883932
Dry mouth 273.43 22.42 1419 391712 198529 109997639
Ascites 271.81 22.42 14 393117 92794 110103374
Blood pressure decreased 271.70 22.42 42 393089 115049 110081119
Hyperglycaemia 265.53 22.42 8 393123 85082 110111086
Blepharospasm 263.99 22.42 595 392536 54256 110141912
Myocardial infarction 263.16 22.42 180 392951 191903 110004265
Encephalopathy 262.97 22.42 5 393126 81050 110115118
Dyspnoea exertional 262.21 22.42 31 393100 104029 110092139
Pleural effusion 260.65 22.42 154 392977 177555 110018613
Heart rate increased 258.33 22.42 94 393037 143740 110052428
Septic shock 252.32 22.42 122 393009 157406 110038762
Lethargy 251.02 22.42 22 393109 93554 110102614
Dislocation of vertebra 249.22 22.42 508 392623 43213 110152955
Nausea 247.37 22.42 3010 390121 1232680 108963488
Red blood cell sedimentation rate increased 245.72 22.42 723 392408 77579 110118589
Cognitive disorder 244.78 22.42 17 393114 87494 110108674
Flushing 243.23 22.42 40 393091 104696 110091472
Leukopenia 241.74 22.42 113 393018 148678 110047490
Pulmonary fibrosis 240.27 22.42 854 392277 101188 110094980
C-reactive protein 240.24 22.42 406 392725 29925 110166243
Mucosal inflammation 236.49 22.42 31 393100 96110 110100058
Dysarthria 236.29 22.42 16 393115 84105 110112063
Mental status changes 234.52 22.42 8 393123 76114 110120054
Myelosuppression 233.07 22.42 30 393101 94310 110101858
Haematuria 232.54 22.42 16 393115 82989 110113179
Pneumonia aspiration 232.50 22.42 14 393117 81219 110114949
Blood glucose increased 232.24 22.42 90 393041 132406 110063762
Injection site reaction 229.38 22.42 768 392363 88302 110107866
Heart rate decreased 226.00 22.42 18 393113 82738 110113430
Angioedema 225.68 22.42 39 393092 98461 110097707
Haemoptysis 225.27 22.42 6 393125 71348 110124820
X-ray abnormal 224.55 22.42 449 392682 37668 110158500
Vision blurred 223.90 22.42 89 393042 128933 110067235
Palpitations 223.74 22.42 145 392986 159067 110037101
Suicidal ideation 222.37 22.42 34 393097 93903 110102265
Chronic kidney disease 221.88 22.42 12 393119 76279 110119889
Hepatic failure 216.19 22.42 6 393125 68733 110127435
Blood bilirubin increased 214.72 22.42 14 393117 75958 110120210
Hepatic function abnormal 214.42 22.42 31 393100 89264 110106904
Acute myocardial infarction 213.47 22.42 24 393107 83753 110112415
Acute respiratory failure 212.32 22.42 14 393117 75246 110120922
Intentional product use issue 212.16 22.42 1559 391572 246347 109949821
Coeliac disease 210.64 22.42 471 392660 42716 110153452
Haemorrhage 210.62 22.42 59 393072 106633 110089535
Neoplasm progression 209.49 22.42 4 393127 64591 110131577
Productive cough 208.16 22.42 73 393058 114232 110081936
COVID-19 immunisation 206.96 22.42 98 393033 1188 110194980
Disorientation 202.80 22.42 12 393119 70659 110125509
Unresponsive to stimuli 202.76 22.42 5 393126 63785 110132383
Rheumatoid nodule 202.59 22.42 302 392829 19994 110176174
Haematochezia 201.59 22.42 79 393052 115445 110080723
Drug tolerance decreased 201.57 22.42 356 392775 27184 110168984
Therapeutic product effect incomplete 199.89 22.42 1422 391709 222383 109973785
Agranulocytosis 199.59 22.42 4 393127 61756 110134412
Blood creatine phosphokinase increased 196.50 22.42 17 393114 73060 110123108
Exposure during pregnancy 196.48 22.42 1140 391991 166284 110029884
Orthostatic hypotension 193.98 22.42 10 393121 66239 110129929
Respiratory distress 193.74 22.42 13 393118 68861 110127307
Exostosis 193.33 22.42 473 392658 45483 110150685
Retinitis 193.07 22.42 383 392748 31944 110164224
Adverse drug reaction 192.61 22.42 815 392316 104744 110091424
Plasma cell myeloma 192.54 22.42 7 393124 62929 110133239
Lupus vulgaris 192.30 22.42 393 392738 33490 110162678
Respiratory arrest 191.59 22.42 3 393128 58296 110137872
Lung disorder 191.55 22.42 1195 391936 178852 110017316
Melaena 190.45 22.42 14 393117 68743 110127425
Feeling abnormal 189.04 22.42 218 392913 180493 110015675
Urinary retention 187.95 22.42 16 393115 69667 110126501
Anti-cyclic citrullinated peptide antibody 185.03 22.42 287 392844 19677 110176491
Weight decreased 182.11 22.42 950 392181 467107 109729061
Ear pain 180.09 22.42 505 392626 52721 110143447
Aggression 176.38 22.42 8 393123 59202 110136966
Cholestasis 176.27 22.42 14 393117 64504 110131664
Cerebral haemorrhage 175 22.42 15 393116 64953 110131215
Prescribed overdose 174.63 22.42 695 392436 86886 110109282
Altered state of consciousness 174.27 22.42 7 393124 57619 110138549
Back injury 173.61 22.42 463 392668 46936 110149232
Haematocrit decreased 173.45 22.42 17 393114 66100 110130068
Joint stiffness 173.30 22.42 580 392551 66663 110129505
Pulmonary hypertension 173.00 22.42 5 393126 55215 110140953
Wheezing 172.08 22.42 1520 391611 253710 109942458
Coronary artery disease 171.87 22.42 25 393106 71665 110124503
Jaundice 170.16 22.42 10 393121 59226 110136942
Aphasia 169.35 22.42 10 393121 58987 110137181
Full blood count abnormal 168.86 22.42 7 393124 56045 110140123
Product label confusion 168.38 22.42 295 392836 22382 110173786
Loss of consciousness 166.05 22.42 276 392855 196030 110000138
Finger deformity 166 22.42 365 392766 32727 110163441
Lupus-like syndrome 165.41 22.42 414 392717 40378 110155790
Shock 163.80 22.42 6 393125 53582 110142586
Hypomagnesaemia 162.44 22.42 14 393117 60356 110135812
Blood urea increased 161.85 22.42 8 393123 54949 110141219
Dysgeusia 159.69 22.42 28 393103 69957 110126211
Thrombosis 159.54 22.42 94 393037 108568 110087600
Pneumonitis 159.33 22.42 38 393093 76493 110119675
Tenosynovitis 159.25 22.42 240 392891 16043 110180125
Blood alkaline phosphatase increased 158.36 22.42 30 393101 70905 110125263
Enthesopathy 157.80 22.42 208 392923 12270 110183898
Hypophagia 157.12 22.42 7 393124 52619 110143549
Product distribution issue 156.01 22.42 127 393004 4219 110191949
Osteonecrosis of jaw 155.61 22.42 3 393128 48014 110148154
Haematemesis 155.58 22.42 15 393116 59093 110137075
Chronic obstructive pulmonary disease 155.29 22.42 98 393033 109060 110087108
Product dose omission issue 155.05 22.42 1788 391343 319994 109876174
Urinary tract infection 154.44 22.42 616 392515 325666 109870502
Restlessness 154.28 22.42 12 393119 56247 110139921
Liver function test abnormal 152.15 22.42 30 393101 68920 110127248
Generalised tonic-clonic seizure 151.83 22.42 11 393120 54669 110141499
Diarrhoea 151.61 22.42 2999 390132 1136506 109059662
Adverse reaction 151.38 22.42 329 392802 29265 110166903
Upper gastrointestinal haemorrhage 148.47 22.42 7 393124 50089 110146079
Maternal exposure timing unspecified 147.85 22.42 267 392864 20746 110175422
Disturbance in attention 147.74 22.42 22 393109 61973 110134195
Breast feeding 147.64 22.42 65 393066 657 110195511
Transient ischaemic attack 147.30 22.42 25 393106 63957 110132211
Prescribed underdose 147.06 22.42 538 392593 64636 110131532
Abdominal pain upper 146.56 22.42 1890 391241 347221 109848947
Arrhythmia 145.92 22.42 34 393097 69541 110126627
Tinnitus 145.39 22.42 21 393110 60519 110135649
Psychotic disorder 145.10 22.42 9 393122 50928 110145240
Ventricular tachycardia 145.00 22.42 8 393123 50001 110146167
Hypothyroidism 144.47 22.42 40 393091 72859 110123309
Pallor 144.31 22.42 16 393115 56451 110139717
Cytomegalovirus infection 142.81 22.42 14 393117 54430 110141738
Blood lactate dehydrogenase increased 142.75 22.42 3 393128 44331 110151837
Colitis 142.64 22.42 94 393037 102229 110093939
Wrong technique in product usage process 142.38 22.42 66 393065 87282 110108886
Pericardial effusion 141.80 22.42 18 393113 57199 110138969
Eosinophilia 141.72 22.42 19 393112 57917 110138251
Obstructive airways disorder 141.63 22.42 5 393126 46144 110150024
Presyncope 141.20 22.42 8 393123 48879 110147289
Skin exfoliation 140.16 22.42 68 393063 87583 110108585
Tubulointerstitial nephritis 139.70 22.42 15 393116 54269 110141899
Dry skin 139.43 22.42 107 393024 107546 110088622
Arthritis 139.38 22.42 1047 392084 166539 110029629
Angina pectoris 137.68 22.42 27 393104 62268 110133900
Rash maculo-papular 137.56 22.42 46 393085 74176 110121992
Speech disorder 137.53 22.42 26 393105 61543 110134625
Urinary incontinence 137.17 22.42 9 393122 48578 110147590
Blood parathyroid hormone decreased 136.75 22.42 199 392932 12890 110183278
Joint dislocation 136.54 22.42 345 392786 33845 110162323
Caesarean section 135.62 22.42 204 392927 13613 110182555
Pancreatitis acute 135.60 22.42 25 393106 60249 110135919
Stevens-Johnson syndrome 134.46 22.42 8 393123 46893 110149275
Rhinorrhoea 134.30 22.42 101 393030 102565 110093603
Pneumonia 133.50 22.42 2253 390878 874461 109321707
Leukocytosis 133.24 22.42 17 393114 53811 110142357
Sinus tachycardia 132.57 22.42 6 393125 44487 110151681
Intentional dose omission 132.28 22.42 248 392883 19832 110176336
Pustular psoriasis 130.89 22.42 199 392932 13406 110182762
Emotional distress 130.58 22.42 7 393124 44840 110151328
Liver function test increased 130.48 22.42 642 392489 87906 110108262
Seronegative arthritis 129.98 22.42 195 392936 12982 110183186
Pruritus 129.59 22.42 2839 390292 578721 109617447
Blood potassium decreased 129.42 22.42 19 393112 54095 110142073
Bone pain 128.58 22.42 36 393095 65097 110131071
Accidental exposure to product 128.23 22.42 14 393117 49994 110146174
Injection site discolouration 128.10 22.42 160 392971 8943 110187225
Granuloma skin 127.38 22.42 178 392953 11105 110185063
Liver disorder 126.48 22.42 903 392228 141340 110054828
Vertigo 126.33 22.42 76 393055 86794 110109374
Drug dependence 125.76 22.42 15 393116 50005 110146163
Respiratory disorder 125.47 22.42 545 392586 70837 110125331
Hepatocellular injury 125.33 22.42 16 393115 50626 110145542
Condition aggravated 125.06 22.42 3458 389673 731378 109464790
Depressed mood 125.01 22.42 31 393100 60778 110135390
Hepatic cirrhosis 124.79 22.42 524 392607 67102 110129066
COVID-19 124.79 22.42 449 392682 244611 109951557
Proteinuria 124.00 22.42 4 393127 40014 110156154
Hepatic cytolysis 123.50 22.42 23 393108 55030 110141138
Dysuria 123.25 22.42 31 393100 60200 110135968
Accidental overdose 122.13 22.42 19 393112 51815 110144353
Dysphonia 121.26 22.42 59 393072 75870 110120298
Lymphopenia 121.06 22.42 5 393126 40165 110156003
Gamma-glutamyltransferase increased 120.82 22.42 34 393097 61275 110134893
Abnormal behaviour 120.62 22.42 4 393127 39035 110157133
Coagulopathy 120.33 22.42 6 393125 40905 110155263
Confusional state 119.46 22.42 2334 390797 466346 109729822
Laryngitis 119.36 22.42 377 392754 42034 110154134
Intentional self-injury 118.70 22.42 3 393128 37426 110158742
Panniculitis 118.68 22.42 205 392926 15377 110180791
Irritability 118.57 22.42 15 393116 47794 110148374
Disseminated intravascular coagulation 118.49 22.42 7 393124 41279 110154889
Red blood cell count decreased 118.48 22.42 43 393088 65880 110130288
Blood pressure fluctuation 118.20 22.42 59 393072 74765 110121403
Haematoma 117.92 22.42 31 393100 58445 110137723
Acute respiratory distress syndrome 117.69 22.42 23 393108 53175 110142993
Drug tolerance 117.02 22.42 211 392920 16374 110179794
Circulatory collapse 115.59 22.42 10 393121 42983 110153185
Diabetic ketoacidosis 115.25 22.42 9 393122 42049 110154119
Product quality issue 115.01 22.42 562 392569 76737 110119431
Blood sodium decreased 114.72 22.42 5 393126 38314 110157854
Nasal congestion 114.66 22.42 108 393023 98174 110097994
Bacteraemia 113.59 22.42 10 393121 42380 110153788
Hemiparesis 113.31 22.42 12 393119 43891 110152277
Migraine 112.92 22.42 1017 392114 170635 110025533
Swollen tongue 112.58 22.42 37 393094 60325 110135843
Erythema 111.87 22.42 594 392537 290853 109905315
Ejection fraction decreased 111.31 22.42 9 393122 40871 110155297
Taste disorder 110.95 22.42 494 392637 64893 110131275
Cardiac disorder 110.55 22.42 67 393064 76213 110119955
Intentional product misuse 110.40 22.42 189 392942 132715 110063453
Muscle spasticity 110.15 22.42 329 392802 35586 110160582
Alanine aminotransferase increased 110.13 22.42 313 392818 183460 110012708
Cerebral infarction 109.37 22.42 25 393106 51813 110144355
Psoriasis 108.81 22.42 861 392270 139132 110057036
Subdural haematoma 108.33 22.42 5 393126 36449 110159719
Red blood cell sedimentation rate 108.02 22.42 112 393019 5102 110191066
Cholelithiasis 107.98 22.42 45 393086 63377 110132791
Transaminases increased 107.89 22.42 45 393086 63345 110132823
Acute myeloid leukaemia 107.76 22.42 7 393124 38103 110158065
Tachypnoea 103.67 22.42 10 393121 39385 110156783
Blood calcium decreased 103.11 22.42 6 393125 35839 110160329
Back pain 102.48 22.42 835 392296 370161 109826007
Drug ineffective for unapproved indication 102.27 22.42 129 393002 102709 110093459
Nightmare 101.92 22.42 10 393121 38853 110157315
Pulmonary arterial hypertension 101.83 22.42 3 393128 32565 110163603
Aspartate aminotransferase increased 100.62 22.42 266 392865 159670 110036498
Myelodysplastic syndrome 100.02 22.42 9 393122 37475 110158693
Pain in jaw 99.70 22.42 29 393102 51148 110145020
Ankylosing spondylitis 99.35 22.42 190 392941 15422 110180746
Product administration error 99.13 22.42 9 393122 37208 110158960
Insomnia 98.78 22.42 1816 391315 358774 109837394
Status epilepticus 98.38 22.42 3 393128 31568 110164600
Throat irritation 96.12 22.42 35 393096 53517 110142651
Diplopia 95.06 22.42 17 393114 41877 110154291
Epilepsy 94.26 22.42 645 392486 99564 110096604
Acute hepatic failure 94.04 22.42 10 393121 36458 110159710
Glaucoma 93.89 22.42 231 392900 22286 110173882
Oedema peripheral 93.86 22.42 733 392398 327927 109868241
Flatulence 93.75 22.42 34 393097 52115 110144053
Full blood count decreased 93.49 22.42 5 393126 32094 110164074
Myoclonus 93.48 22.42 6 393125 32992 110163176
Alanine aminotransferase abnormal 93.31 22.42 139 392992 9195 110186973
Clostridium difficile colitis 92.59 22.42 21 393110 43757 110152411
Red blood cell sedimentation rate abnormal 92.38 22.42 242 392889 24267 110171901
Drug resistance 91.25 22.42 43 393088 56331 110139837
Rash erythematous 90.76 22.42 94 393037 81738 110114430
Head injury 90.25 22.42 21 393110 42996 110153172
Hot flush 90.24 22.42 62 393069 65974 110130194
Ear infection 89.70 22.42 451 392680 62281 110133887
Hyperlipidaemia 89.51 22.42 11 393120 35837 110160331
Lip swelling 89.46 22.42 34 393097 50633 110145535
Glomerular filtration rate decreased 89.34 22.42 3 393128 28953 110167215
Bronchopulmonary aspergillosis 89.06 22.42 4 393127 29859 110166309
Blindness 88.75 22.42 12 393119 36347 110159821
Withdrawal syndrome 88.03 22.42 6 393125 31374 110164794
Swelling face 87.51 22.42 120 393011 92201 110103967
Vomiting 87.01 22.42 2519 390612 908156 109288012
Myocarditis 86.55 22.42 5 393126 30050 110166118
Gastric ulcer 86.48 22.42 18 393113 39809 110156359
Mitral valve incompetence 86.30 22.42 9 393122 33320 110162848
Electrolyte imbalance 86.27 22.42 14 393117 37014 110159154
Neutrophil count increased 85.63 22.42 11 393120 34641 110161527
Cyanosis 85.48 22.42 5 393126 29736 110166432
Dyspepsia 85.23 22.42 1046 392085 189919 110006249
Metastases to bone 85.16 22.42 7 393124 31365 110164803
Walking aid user 84.90 22.42 238 392893 24837 110171331
Paraesthesia oral 84.89 22.42 10 393121 33661 110162507
Blood pressure systolic increased 84.74 22.42 102 393029 82889 110113279
COVID-19 pneumonia 84.43 22.42 15 393116 37128 110159040
Fluid retention 83.10 22.42 129 393002 94178 110101990
Pneumothorax 82.98 22.42 13 393118 35272 110160896
Colitis microscopic 82.77 22.42 161 392970 13233 110182935
Sleep apnoea syndrome 82.40 22.42 21 393110 40426 110155742
Polyneuropathy 81.98 22.42 9 393122 32003 110164165
Fatigue 81.41 22.42 5183 387948 1210775 108985393
Eczema 81.36 22.42 82 393049 72211 110123957
Tongue disorder 81.31 22.42 166 392965 14132 110182036
Ischaemic stroke 81.09 22.42 23 393108 41240 110154928
Hyperthyroidism 80.91 22.42 6 393125 29255 110166913
Therapy partial responder 79.95 22.42 17 393114 37044 110159124
Feeling cold 78.85 22.42 13 393118 33974 110162194
Bronchospasm 78.72 22.42 8 393123 30231 110165937
Cytopenia 78.32 22.42 8 393123 30108 110166060
Axial spondyloarthritis 78.20 22.42 45 393086 833 110195335
Impaired quality of life 77.99 22.42 8 393123 30009 110166159
Ileus 77.78 22.42 9 393122 30720 110165448
Visual acuity reduced 77.63 22.42 11 393120 32162 110164006
Heart rate irregular 77.56 22.42 14 393117 34260 110161908
Hypoalbuminaemia 77.19 22.42 7 393124 28967 110167201
Oedema 77.06 22.42 1110 392021 208866 109987302
Metastases to liver 76.82 22.42 16 393115 35370 110160798
Therapy non-responder 76.53 22.42 876 392255 156431 110039737
Gout 76.42 22.42 18 393113 36548 110159620
Blood pressure diastolic decreased 76.32 22.42 17 393114 35868 110160300
Rheumatoid factor negative 76.08 22.42 51 393080 1249 110194919
Dementia 76.02 22.42 11 393120 31662 110164506
Myopathy 75.58 22.42 3 393128 24957 110171211
Cardiomyopathy 75.21 22.42 14 393117 33511 110162657
Arteriosclerosis 74.92 22.42 3 393128 24764 110171404
Hepatic encephalopathy 74.81 22.42 7 393124 28249 110167919
Blood iron abnormal 73.92 22.42 53 393078 1451 110194717
Femur fracture 73.40 22.42 33 393098 44436 110151732
Coordination abnormal 73.25 22.42 4 393127 25224 110170944
Muscle twitching 72.78 22.42 10 393121 29925 110166243
Cardiac failure acute 72.55 22.42 3 393128 24075 110172093
Neuralgia 72.49 22.42 41 393090 48437 110147731
Oropharyngeal pain 72.10 22.42 243 392888 135033 110061135
Systemic lupus erythematosus rash 72.06 22.42 59 393072 1976 110194192
Blood pressure systolic abnormal 71.97 22.42 4 393127 24846 110171322
Mental disorder 71.95 22.42 24 393107 38767 110157401
Haemorrhoids 71.76 22.42 19 393112 35653 110160515
Aspergillus infection 71.56 22.42 5 393126 25611 110170557
Transfusion 71.08 22.42 5 393126 25467 110170701
Pseudomonas infection 70.90 22.42 8 393123 27845 110168323
Skin necrosis 70.70 22.42 202 392929 21310 110174858
Hypoacusis 70.31 22.42 19 393112 35172 110160996
Fear 69.52 22.42 3 393128 23190 110172978
Inability to afford medication 69.48 22.42 79 393052 3997 110192171
Hypocalcaemia 69.25 22.42 78 393053 65288 110130880
Abdominal pain 69.15 22.42 1346 391785 511643 109684525
Infusion site reaction 69.12 22.42 177 392954 17505 110178663
Pyrexia 69.03 22.42 2555 390576 895710 109300458
Device related infection 68.97 22.42 27 393104 39492 110156676
Hallucination, auditory 68.68 22.42 7 393124 26390 110169778
Breast cancer stage II 68.64 22.42 234 392897 27141 110169027
Haemodynamic instability 68.47 22.42 3 393128 22885 110173283
Peritonitis 68.24 22.42 16 393115 32591 110163577
Restless legs syndrome 68.24 22.42 5 393126 24621 110171547
Joint destruction 68.19 22.42 132 392999 10811 110185357
Cardiomegaly 67.90 22.42 11 393120 29119 110167049
Supraventricular tachycardia 67.55 22.42 5 393126 24417 110171751
Sudden death 67.46 22.42 5 393126 24390 110171778
Acidosis 67.25 22.42 3 393128 22528 110173640
Disease recurrence 67.21 22.42 70 393061 60714 110135454
Myocardial ischaemia 67.08 22.42 8 393123 26676 110169492
Respiratory rate increased 66.98 22.42 6 393125 25077 110171091
Dizziness 66.40 22.42 1932 391199 696261 109499907
Bacterial infection 65.92 22.42 41 393090 45995 110150173
Subarachnoid haemorrhage 65.37 22.42 13 393118 29689 110166479
Delusion 65.32 22.42 5 393126 23750 110172418
Porphyria acute 65.31 22.42 180 392951 18600 110177568
Anxiety 65.06 22.42 850 392281 344228 109851940
Haemophagocytic lymphohistiocytosis 65.04 22.42 16 393115 31543 110164625
Oral pain 64.66 22.42 26 393105 37418 110158750
Acute generalised exanthematous pustulosis 64.28 22.42 3 393128 21661 110174507
Procedural pain 64.25 22.42 23 393108 35542 110160626
Blood test abnormal 63.89 22.42 12 393119 28542 110167626
Activated partial thromboplastin time prolonged 63.56 22.42 4 393127 22364 110173804
Body temperature decreased 63.21 22.42 26 393105 36909 110159259
Product substitution issue 63.00 22.42 5 393126 23056 110173112
Lung infiltration 62.87 22.42 7 393124 24621 110171547
Cardiac murmur 62.87 22.42 7 393124 24621 110171547
Hypertension 62.87 22.42 2310 390821 507774 109688394
Skin lesion 62.28 22.42 55 393076 51576 110144592
Eosinophil count increased 62.21 22.42 3 393128 21055 110175113
Rash macular 61.86 22.42 30 393101 38656 110157512
Crying 61.28 22.42 9 393122 25619 110170549
Blood uric acid increased 60.73 22.42 4 393127 21525 110174643
Sneezing 60.72 22.42 19 393112 31965 110164203
Toxic skin eruption 60.64 22.42 12 393119 27503 110168665
Sensory loss 60.49 22.42 4 393127 21453 110174715
Asthenia 60.48 22.42 1927 391204 687072 109509096
Polyarthritis 60.33 22.42 176 392955 18787 110177381
Oesophagitis 60.28 22.42 14 393117 28701 110167467
Spondylitis 60.23 22.42 128 393003 11210 110184958
Osteoporosis 59.68 22.42 521 392610 86631 110109537
Eye pruritus 59.54 22.42 21 393110 32754 110163414
Gastritis 59.19 22.42 62 393069 53637 110142531
Eating disorder 59.18 22.42 18 393113 30840 110165328
Complication associated with device 58.86 22.42 3 393128 20070 110176098
Device malfunction 58.80 22.42 10 393121 25548 110170620
Blood glucose decreased 58.76 22.42 16 393115 29472 110166696
Dermatitis atopic 58.74 22.42 10 393121 25531 110170637
Skin haemorrhage 58.72 22.42 9 393122 24818 110171350
Klebsiella infection 58.64 22.42 3 393128 20006 110176162
Petechiae 58.60 22.42 7 393124 23310 110172858
Neck pain 58.23 22.42 682 392449 122448 110073720
Blood triglycerides increased 58.15 22.42 8 393123 23918 110172250
Device issue 57.99 22.42 25 393106 34510 110161658
Tricuspid valve incompetence 57.98 22.42 8 393123 23865 110172303
Pemphigoid 57.61 22.42 3 393128 19704 110176464
Arthrodesis 57.42 22.42 59 393072 2659 110193509
Arteriosclerosis coronary artery 57.41 22.42 10 393121 25108 110171060
Chronic sinusitis 57.30 22.42 10 393121 25074 110171094
Blood albumin decreased 57.02 22.42 14 393117 27638 110168530
Ankle arthroplasty 56.85 22.42 57 393074 2494 110193674
Ulcer haemorrhage 56.65 22.42 193 392938 22378 110173790
Chromaturia 56.53 22.42 17 393114 29343 110166825
Abdominal pain lower 56.51 22.42 31 393100 37252 110158916
Disability 56.39 22.42 235 392896 29988 110166180
Skin discolouration 55.91 22.42 55 393076 48991 110147177
Rib fracture 55.83 22.42 25 393106 33745 110162423
Renal disorder 55.82 22.42 56 393075 49423 110146745
Deformity 55.48 22.42 116 393015 10044 110186124
Mania 55.47 22.42 5 393126 20791 110175377
Grip strength 55.42 22.42 109 393022 9032 110187136
Foot operation 55.42 22.42 96 393035 7217 110188951
Skin fissures 55.33 22.42 10 393121 24448 110171720
Hip fracture 55.09 22.42 28 393103 35123 110161045
Aspiration 54.72 22.42 20 393111 30513 110165655
Atrial flutter 54.71 22.42 10 393121 24252 110171916
Twin pregnancy 54.67 22.42 37 393094 921 110195247
Ageusia 54.40 22.42 4 393127 19641 110176527
Enterococcal infection 54.04 22.42 5 393126 20361 110175807
Mental impairment 54.02 22.42 8 393123 22631 110173537
Memory impairment 53.57 22.42 991 392140 195953 110000215
Face oedema 53.45 22.42 26 393105 33443 110162725
Poor venous access 53.41 22.42 11 393120 24511 110171657
Faeces discoloured 53.27 22.42 27 393104 33921 110162247
Macular degeneration 53.22 22.42 7 393124 21652 110174516
Poor quality sleep 52.73 22.42 17 393114 28060 110168108
Glycosylated haemoglobin increased 52.69 22.42 10 393121 23609 110172559
Benign prostatic hyperplasia 52.61 22.42 3 393128 18231 110177937
Treatment noncompliance 52.57 22.42 113 393018 72877 110123291
Nervousness 52.52 22.42 33 393098 36818 110159350
Oral candidiasis 52.42 22.42 49 393082 44711 110151457
Influenza 52.12 22.42 369 392762 168732 110027436
Rales 52.05 22.42 12 393119 24727 110171441
Panic attack 51.79 22.42 19 393112 28921 110167247
Gastric disorder 51.39 22.42 245 392886 33112 110163056
Splenomegaly 51.31 22.42 12 393119 24486 110171682
Tendonitis 51.18 22.42 206 392925 25877 110170291
Paranoia 50.93 22.42 9 393122 22365 110173803
Hypogammaglobulinaemia 50.52 22.42 6 393125 20070 110176098
Myasthenia gravis 50.42 22.42 8 393123 21503 110174665
Malnutrition 50.38 22.42 17 393114 27262 110168906
Hepatitis cholestatic 50.34 22.42 3 393128 17563 110178605
Cold sweat 49.85 22.42 9 393122 22022 110174146
Decubitus ulcer 49.69 22.42 4 393127 18232 110177936
Nail operation 49.53 22.42 44 393087 1650 110194518
Immune thrombocytopenia 49.18 22.42 10 393121 22484 110173684
Purpura 49.04 22.42 13 393118 24375 110171793
Candida infection 49.01 22.42 59 393072 47950 110148218
Metastases to lung 48.90 22.42 11 393120 23052 110173116
Pollakiuria 48.74 22.42 51 393080 44144 110152024
Duodenal ulcer 48.69 22.42 6 393125 19508 110176660
Nocturia 48.39 22.42 3 393128 16987 110179181
Latent tuberculosis 48.30 22.42 65 393066 3912 110192256
Atrioventricular block 48.01 22.42 3 393128 16874 110179294
Limb injury 47.97 22.42 38 393093 37598 110158570
Hiatus hernia 47.95 22.42 19 393112 27587 110168581
Anal incontinence 47.53 22.42 10 393121 21954 110174214
Infusion site pain 46.97 22.42 4 393127 17415 110178753
Eye pain 46.60 22.42 66 393065 50033 110146135
Toothache 46.59 22.42 13 393118 23562 110172606
Second primary malignancy 46.47 22.42 5 393126 18063 110178105
Interstitial lung disease 46.46 22.42 297 392834 139037 110057131
Gangrene 46.20 22.42 3 393128 16338 110179830
Immune reconstitution inflammatory syndrome 45.82 22.42 3 393128 16223 110179945
Nervous system disorder 45.77 22.42 28 393103 31693 110164475
Sputum discoloured 45.71 22.42 21 393110 27924 110168244
Escherichia infection 45.48 22.42 14 393117 23802 110172366
Hypokinesia 45.11 22.42 11 393120 21815 110174353
Throat tightness 45.02 22.42 32 393099 33457 110162711
Body temperature increased 44.98 22.42 341 392790 54372 110141796
Anaphylactic shock 44.94 22.42 71 393060 51475 110144693
Intestinal obstruction 44.83 22.42 75 393056 53152 110143016
Fine motor skill dysfunction 44.49 22.42 80 393051 6194 110189974
Renal cyst 44.35 22.42 6 393125 18166 110178002
Diabetes mellitus 44.24 22.42 192 392939 99189 110096979
Retching 43.91 22.42 13 393118 22669 110173499
Hepatomegaly 43.85 22.42 11 393120 21403 110174765
Epstein-Barr virus infection 43.85 22.42 7 393124 18731 110177437
Post procedural complication 43.66 22.42 20 393111 26638 110169530
Micturition urgency 43.49 22.42 8 393123 19312 110176856
Apathy 43.05 22.42 4 393127 16235 110179933
Proctitis 42.74 22.42 5 393126 16922 110179246
Swollen joint count 42.74 22.42 95 393036 8579 110187589
Cytology abnormal 42.68 22.42 22 393109 324 110195844
Multiple sclerosis 42.52 22.42 19 393112 25679 110170489
Dyslipidaemia 42.15 22.42 4 393127 15961 110180207
Large intestine perforation 41.77 22.42 5 393126 16624 110179544
Drug use disorder 41.74 22.42 7 393124 18067 110178101
Basal cell carcinoma 41.74 22.42 290 392841 44980 110151188
Tuberculin test positive 41.61 22.42 58 393073 3610 110192558
Electrocardiogram abnormal 41.57 22.42 8 393123 18701 110177467
Lipase increased 41.45 22.42 8 393123 18664 110177504
Blood pressure diastolic abnormal 41.31 22.42 20 393111 25795 110170373
Appendicitis 41.24 22.42 25 393106 28439 110167729
Vasculitis 41.16 22.42 40 393091 35833 110160335
Middle insomnia 41.09 22.42 11 393120 20491 110175677
Cataract 40.85 22.42 145 392986 79340 110116828
Cholangitis 40.81 22.42 5 393126 16330 110179838
Cellulitis 40.80 22.42 271 392860 125745 110070423
Anger 40.43 22.42 9 393122 18998 110177170
Dizziness postural 40.38 22.42 3 393128 14606 110181562
Hypertensive crisis 40.36 22.42 18 393113 24354 110171814
Lymphadenopathy 40.26 22.42 106 393025 63729 110132439
Hypertriglyceridaemia 40.22 22.42 5 393126 16149 110180019
Hyperuricaemia 40.12 22.42 3 393128 14528 110181640
Mood altered 40.04 22.42 13 393118 21362 110174806
Encephalitis 39.91 22.42 9 393122 18830 110177338
Sensory disturbance 39.70 22.42 7 393124 17422 110178746
Peripheral sensory neuropathy 39.55 22.42 6 393125 16674 110179494
Hepatic enzyme 39.42 22.42 68 393063 5095 110191073
Drug-induced liver injury 39.10 22.42 622 392509 119445 110076723
Atrioventricular block first degree 39.10 22.42 3 393128 14222 110181946
Metastases to lymph nodes 39.07 22.42 4 393127 15028 110181140
Female genital tract fistula 39.04 22.42 6 393125 16513 110179655
Cholecystitis acute 39.02 22.42 5 393126 15777 110180391
Dry eye 38.84 22.42 88 393043 55705 110140463
Hypersomnia 38.80 22.42 26 393105 28035 110168133
Lymphoedema 38.73 22.42 4 393127 14925 110181243
Atelectasis 38.68 22.42 44 393087 36668 110159500
Rectal haemorrhage 38.65 22.42 258 392873 119575 110076593
Red cell distribution width increased 38.12 22.42 8 393123 17594 110178574
Intestinal ischaemia 37.96 22.42 6 393125 16173 110179995
Hydronephrosis 37.95 22.42 13 393118 20652 110175516
Transaminases abnormal 37.86 22.42 30 393101 958 110195210
Transplant rejection 37.86 22.42 20 393111 24547 110171621
Cardiac failure chronic 37.71 22.42 3 393128 13808 110182360
Spondyloarthropathy 37.70 22.42 37 393094 1577 110194591
Thirst 37.60 22.42 15 393116 21692 110174476
Food allergy 37.60 22.42 12 393119 19936 110176232
Dysstasia 37.59 22.42 37 393094 32949 110163219
Facial pain 37.59 22.42 5 393126 15334 110180834
Device leakage 37.54 22.42 6 393125 16042 110180126
Coronary artery stenosis 37.54 22.42 3 393128 13755 110182413
Arterial occlusive disease 37.49 22.42 5 393126 15303 110180865
Lacrimation increased 37.29 22.42 33 393098 30917 110165251
Incontinence 37.20 22.42 7 393124 16628 110179540
Urosepsis 36.61 22.42 33 393098 30642 110165526
Therapeutic response decreased 36.52 22.42 513 392618 95986 110100182
Congestive cardiomyopathy 36.40 22.42 4 393127 14215 110181953
Abortion spontaneous 36.08 22.42 227 392904 34055 110162113
Osteonecrosis 36.03 22.42 40 393091 33701 110162467
Central nervous system lesion 35.97 22.42 6 393125 15547 110180621
Left ventricular hypertrophy 35.82 22.42 3 393128 13241 110182927
Cholecystitis 35.76 22.42 24 393107 25858 110170310
Nasal polyps 35.68 22.42 3 393128 13197 110182971
Blood urine present 35.54 22.42 21 393110 24224 110171944
Ecchymosis 35.32 22.42 9 393122 17329 110178839
Rhinitis 35.27 22.42 18 393113 22527 110173641
Gastroenteritis 35.21 22.42 52 393079 38748 110157420
Rash papular 35.11 22.42 28 393103 27611 110168557
Pelvic pain 35.04 22.42 7 393124 15935 110180233
Extremity contracture 35 22.42 37 393094 1724 110194444
Bundle branch block left 34.64 22.42 3 393128 12885 110183283
Coronary artery occlusion 34.51 22.42 7 393124 15765 110180403
Surgery 34.33 22.42 258 392873 41025 110155143
Concomitant disease aggravated 34.30 22.42 8 393123 16356 110179812
Erythema multiforme 34.28 22.42 16 393115 21081 110175087
Ventricular extrasystoles 34.06 22.42 19 393112 22622 110173546
Mouth haemorrhage 34.02 22.42 4 393127 13484 110182684
Dermatitis acneiform 34.00 22.42 3 393128 12692 110183476
Paraesthesia 33.94 22.42 1252 391879 275269 109920899
Intestinal perforation 33.86 22.42 16 393115 20928 110175240
Skin disorder 33.85 22.42 63 393068 42850 110153318
Skin reaction 33.81 22.42 157 392974 20987 110175181
Hepatitis 33.78 22.42 478 392653 89576 110106592
Palmoplantar pustulosis 33.69 22.42 28 393103 958 110195210
Hepatitis C 33.59 22.42 3 393128 12570 110183598
Small intestinal obstruction 33.51 22.42 39 393092 32174 110163994
Drug level decreased 33.49 22.42 12 393119 18536 110177632
Rhinitis allergic 33.39 22.42 11 393120 17911 110178257
Prostatic specific antigen increased 33.39 22.42 3 393128 12508 110183660
Rheumatoid lung 33.27 22.42 57 393074 4247 110191921
Anosmia 33.26 22.42 3 393128 12469 110183699
Spinal compression fracture 33.04 22.42 12 393119 18380 110177788
Bunion operation 32.71 22.42 27 393104 915 110195253
Fear of injection 32.58 22.42 87 393044 8824 110187344
Chest pain 32.15 22.42 1056 392075 375319 109820849
Spinal fusion surgery 32.08 22.42 88 393043 9068 110187100
Failure to thrive 31.92 22.42 5 393126 13569 110182599
Exercise tolerance decreased 31.92 22.42 3 393128 12064 110184104
Emotional disorder 31.77 22.42 9 393122 16151 110180017
Pneumocystis jirovecii pneumonia 31.75 22.42 65 393066 42670 110153498
Sinus disorder 31.56 22.42 42 393089 32686 110163482
Incorrect dose administered 31.52 22.42 227 392904 103414 110092754
Head discomfort 31.51 22.42 14 393117 18986 110177182
Enterocolitis 31.37 22.42 14 393117 18935 110177233
Musculoskeletal chest pain 31.02 22.42 34 393097 28813 110167355
Blood pressure abnormal 30.71 22.42 21 393110 22403 110173765
Emphysema 30.57 22.42 16 393115 19740 110176428
Lung opacity 30.55 22.42 3 393128 11649 110184519
Respiratory syncytial virus infection 30.52 22.42 7 393124 14477 110181691
Injection site pallor 30.48 22.42 11 393120 62 110196106
Hypermobility syndrome 30.47 22.42 21 393110 539 110195629
Bedridden 30.42 22.42 111 393020 13314 110182854
Musculoskeletal disorder 30.35 22.42 160 392971 22504 110173664
Systemic inflammatory response syndrome 30.23 22.42 5 393126 13038 110183130
Facial paralysis 30.17 22.42 25 393106 24189 110171979
Burning sensation 30.03 22.42 135 392996 69077 110127091
Vaginal discharge 30.01 22.42 13 393118 17895 110178273
Blood glucose abnormal 29.83 22.42 5 393126 12911 110183257
Clostridium difficile infection 29.61 22.42 91 393040 52038 110144130
Drug effective for unapproved indication 29.55 22.42 7 393124 14160 110182008
Device difficult to use 29.44 22.42 15 393116 18790 110177378
Nephropathy 29.42 22.42 6 393125 13461 110182707
Staphylococcal infection 29.41 22.42 138 392993 69806 110126362
Prolonged pregnancy 29.37 22.42 10 393121 46 110196122
Therapeutic response unexpected 29.24 22.42 25 393106 23818 110172350
Eye irritation 29.23 22.42 46 393085 33406 110162762
Tuberculosis 29.18 22.42 133 392998 17641 110178527
Endocarditis 29.12 22.42 6 393125 13365 110182803
Blood iron decreased 29.09 22.42 16 393115 19198 110176970
Upper-airway cough syndrome 29.08 22.42 10 393121 15847 110180321
Hypoaesthesia oral 29.04 22.42 12 393119 16990 110179178
White blood cell count increased 29.02 22.42 213 392918 96629 110099539
Nerve injury 29.02 22.42 94 393037 10619 110185549
Product complaint 28.96 22.42 7 393124 13965 110182203
Dermatitis bullous 28.94 22.42 13 393118 17516 110178652
Bone disorder 28.82 22.42 20 393111 21172 110174996
Herpes simplex 28.81 22.42 10 393121 15754 110180414
Erectile dysfunction 28.75 22.42 15 393116 18541 110177627
Iron deficiency 28.53 22.42 15 393116 18461 110177707
Parosmia 28.52 22.42 6 393125 13174 110182994
Eye haemorrhage 28.47 22.42 4 393127 11770 110184398
Abdominal tenderness 28.38 22.42 5 393126 12452 110183716
Eye swelling 28.36 22.42 46 393085 33002 110163166
Intervertebral disc protrusion 28.32 22.42 34 393097 27664 110168504
Motor dysfunction 28.25 22.42 27 393104 24379 110171789
Blood folate decreased 28.11 22.42 38 393093 2297 110193871
Premature delivery 28.10 22.42 196 392935 30436 110165732
Protein total decreased 28.04 22.42 3 393128 10887 110185281
Faecaloma 28.04 22.42 9 393122 14899 110181269
Hepatitis acute 27.87 22.42 16 393115 18750 110177418
Bladder cancer 27.79 22.42 19 393112 20273 110175895
Adjustment disorder 27.73 22.42 3 393128 10792 110185376
Seasonal allergy 27.64 22.42 18 393113 19704 110176464
Normal newborn 27.57 22.42 152 392979 21744 110174424
Tendon rupture 27.38 22.42 8 393123 14070 110182098
Eyelid oedema 27.35 22.42 10 393121 15252 110180916
Major depression 27.16 22.42 3 393128 10618 110185550
Pain of skin 27.10 22.42 19 393112 20010 110176158
Gingival pain 27.05 22.42 11 393120 15725 110180443
Overlap syndrome 26.85 22.42 82 393049 8977 110187191
Product storage error 26.80 22.42 150 392981 21578 110174590
Influenza like illness 26.71 22.42 194 392937 88218 110107950
Paralysis 26.66 22.42 11 393120 15589 110180579
Nephrotic syndrome 26.64 22.42 8 393123 13823 110182345
Disease susceptibility 26.50 22.42 16 393115 325 110195843
Vaginal haemorrhage 26.47 22.42 30 393101 25044 110171124
Post procedural haemorrhage 26.41 22.42 11 393120 15501 110180667
Hydrocephalus 26.36 22.42 3 393128 10372 110185796
Rhinovirus infection 26.28 22.42 5 393126 11784 110184384
Neoplasm 26.26 22.42 4 393127 11083 110185085
Affect lability 26.13 22.42 17 393114 18620 110177548
Stress 25.99 22.42 244 392887 105104 110091064
Abnormal loss of weight 25.97 22.42 3 393128 10254 110185914
Adenovirus infection 25.97 22.42 4 393127 10990 110185178
Diffuse large B-cell lymphoma 25.92 22.42 12 393119 15886 110180282
Escherichia bacteraemia 25.67 22.42 3 393128 10161 110186007
Ulcer 25.60 22.42 250 392881 42866 110153302
Sinus congestion 25.57 22.42 43 393088 30416 110165752
Feeding disorder 25.47 22.42 23 393108 21339 110174829
Amnesia 25.46 22.42 521 392610 104887 110091281
Ventricular arrhythmia 25.42 22.42 3 393128 10084 110186084
Ketoacidosis 25.42 22.42 3 393128 10084 110186084
Hypovolaemic shock 25.39 22.42 10 393121 14573 110181595
Viral infection 25.31 22.42 100 393031 53039 110143129
Osteopenia 25.21 22.42 25 393106 22184 110173984
Colitis ischaemic 25.15 22.42 16 393115 17734 110178434
Haemorrhagic stroke 24.77 22.42 9 393122 13780 110182388
Vitamin D deficiency 24.58 22.42 18 393113 18534 110177634
Systemic infection 24.55 22.42 3 393128 9816 110186352
Cystitis 24.52 22.42 136 392995 65900 110130268
Intracranial pressure increased 24.51 22.42 4 393127 10531 110185637
Nodule 24.41 22.42 199 392932 32432 110163736
Eye movement disorder 24.25 22.42 3 393128 9725 110186443
Respiratory tract infection 24.21 22.42 152 392979 71465 110124703
Skin irritation 24.11 22.42 14 393117 16305 110179863
Initial insomnia 24.04 22.42 4 393127 10385 110185783
Peripheral ischaemia 24.00 22.42 5 393126 11053 110185115
Rotator cuff syndrome 23.98 22.42 15 393116 16779 110179389
Sacroiliitis 23.94 22.42 54 393077 4924 110191244
Tension headache 23.89 22.42 3 393128 9615 110186553
Decreased activity 23.74 22.42 5 393126 10969 110185199
Skin abrasion 23.66 22.42 14 393117 16137 110180031
Eyelid ptosis 23.43 22.42 9 393122 13318 110182850
Injection site extravasation 23.35 22.42 4 393127 10165 110186003
Pulmonary thrombosis 23.33 22.42 10 393121 13853 110182315
Multiple-drug resistance 23.17 22.42 9 393122 13226 110182942
Dermatitis exfoliative 22.91 22.42 6 393125 11341 110184827
Gingival bleeding 22.90 22.42 22 393109 19817 110176351
Product administration interrupted 22.74 22.42 6 393125 11286 110184882
Amenorrhoea 22.64 22.42 3 393128 9228 110186940
Localised oedema 22.61 22.42 3 393128 9220 110186948
Disseminated large cell lymphoma 22.60 22.42 9 393122 69 110196099
Affective disorder 22.59 22.42 6 393125 11235 110184933
Psychiatric symptom 22.58 22.42 3 393128 9210 110186958
Leukoencephalopathy 22.52 22.42 3 393128 9192 110186976

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AB05 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Tumor necrosis factor alpha (TNF-alpha) inhibitors
FDA MoA N0000175451 Tumor Necrosis Factor Receptor Blocking Activity
MeSH PA D000079424 Tumor Necrosis Factor Inhibitors
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018501 Antirheumatic Agents
FDA EPC N0000175610 Tumor Necrosis Factor Blocker
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35842 antirheumatic drug

Related Drugs by ATC class:

L04AB Tumor necrosis factor alpha (TNF-alpha) inhibitors 4 drugs
adalimumabetanerceptgolimumabinfliximab

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

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Psoriasis with arthropathy indication 33339001
Crohn's disease indication 34000006
Rheumatoid arthritis indication 69896004 DOID:7148
Psoriatic arthritis indication 156370009 DOID:9008
Plaque psoriasis indication 200965009
Pustular psoriasis indication 200973000
Erythrodermic psoriasis indication 200977004




🐶 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
Tumor necrosis factor Cytokine ANTIBODY BINDING Kd 10.05 DRUG LABEL DRUG LABEL

External reference:

IDSource
D03441 KEGG_DRUG
4028807 VUID
N0000178499 NUI
4027433 VANDF
4028807 VANDF
CHEMBL1201831 ChEMBL_ID
6774 IUPHAR_LIGAND_ID
DB08904 DRUGBANK_ID
709271 RXNORM
136438 MMSL
25282 MMSL
d07134 MMSL
012650 NDDF
430306004 SNOMEDCT_US
430307008 SNOMEDCT_US
C1872109 UMLSCUI
D000068582 MESH_DESCRIPTOR_UI
CHEBI:757040 CHEBI
CHEMBL4297565 ChEMBL_ID
8448 INN_ID
UMD07X179E UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cimzia HUMAN PRESCRIPTION DRUG LABEL 1 50474-710 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Cimzia HUMAN PRESCRIPTION DRUG LABEL 1 50474-710 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Cimzia HUMAN PRESCRIPTION DRUG LABEL 1 50474-750 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections
Cimzia HUMAN PRESCRIPTION DRUG LABEL 1 50474-750 INJECTION, SOLUTION 200 mg SUBCUTANEOUS BLA 31 sections