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

Stem definitionDrug idCAS RN
1883 22204-53-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • methoxypropiocin
  • naproxen
  • naprosyn
  • aproxen
  • naproxen sodium
  • aleve
An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
  • Molecular weight: 230.26
  • Formula: C14H14O3
  • CLOGP: 2.82
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.53
  • ALOGS: -3.65
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.50 g O
0.50 g R
0.50 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.12 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 108.57 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.09 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.07 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 16.63 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.127 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.566 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 144.544 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 4.966 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.710 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 2.340 % High 1
herg hERG pIC50 4.058 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 5.395 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.404 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.720 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,BTK,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PRKDC,TGFBR1 19
kinase-selectivity-class AXL,BRAF,EIF2AK3,GRK2,MAP2K6,PDK4 6
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.758 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.275 High 1
mh-clint Mouse hepatocyte intrinsic clearance 32.584 High 1
mppb Mouse plasma protein binding (% unbound) 5.100 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.389 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 2.070 % High 1
rat-kpuu-brain Rat brain Kpuu 0.192 % High 1
rh-clint Rat hepatocyte intrinsic clearance 9.727 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 93.040 % High 1
rppb Rat plasma protein binding (% unbound) 0.680 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 872.971 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 11, 1976 FDA ROCHE PALO

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
Psoriatic arthropathy 558.14 9.74 2349 426308 225986 89973804
Death 520.79 9.74 848 427809 455703 89744087
C-reactive protein abnormal 475.89 9.74 1505 427152 125924 90073866
Fibromyalgia 461.13 9.74 2066 426591 204203 89995587
Neutropenia 451.06 9.74 251 428406 224653 89975137
Anaemia 434.15 9.74 622 428035 352180 89847610
Synovitis 378.37 9.74 2763 425894 326989 89872801
Injury 370.78 9.74 1880 426777 195469 90004321
Joint range of motion decreased 368.15 9.74 1442 427215 134201 90065589
Febrile neutropenia 354.97 9.74 152 428505 158197 90041593
Wound infection 350.08 9.74 1204 427453 105198 90094592
Red blood cell sedimentation rate abnormal 335.65 9.74 489 428168 23715 90176075
Type 2 diabetes mellitus 325.30 9.74 1853 426804 201391 89998399
Migraine 312.73 9.74 1748 426909 188644 90011146
Disease progression 312.19 9.74 176 428481 156439 90043351
Ankylosing spondylitis 310.44 9.74 346 428311 12787 90187003
Inflammation 309.67 9.74 1664 426993 176928 90022862
Gait inability 305.67 9.74 1438 427219 145018 90054772
Facet joint syndrome 303.53 9.74 1090 427567 97299 90102491
Pancytopenia 302.28 9.74 96 428561 120167 90079623
Mobility decreased 301.94 9.74 2126 426531 248608 89951182
Obesity 301.28 9.74 1140 427517 104367 90095423
Musculoskeletal stiffness 299.99 9.74 2413 426244 294119 89905671
Pharyngitis 290.78 9.74 434 428223 21513 90178277
Blepharospasm 286.02 9.74 736 427921 54709 90145081
Thrombocytopenia 275.81 9.74 349 428308 208376 89991414
Drug interaction 275.06 9.74 558 428099 275895 89923895
Lip dry 269.63 9.74 1068 427589 99887 90099903
C-reactive protein increased 265.82 9.74 1616 427041 179773 90020017
Hypoaesthesia 264.50 9.74 2455 426202 311755 89888035
Hyponatraemia 263.37 9.74 152 428505 133386 90066404
Liver injury 256.57 9.74 1530 427127 169037 90030753
Bursitis 248.41 9.74 1256 427401 130398 90069392
Breast cancer stage III 247.35 9.74 920 427737 83527 90116263
Cardiac failure 247.14 9.74 104 428553 109392 90090398
Rheumatic fever 243.57 9.74 1394 427263 151727 90048063
Sepsis 234.09 9.74 304 428353 179510 90020280
Impaired healing 229.29 9.74 1892 426765 232307 89967483
Peripheral venous disease 225.85 9.74 890 427767 83031 90116759
Grip strength decreased 225.55 9.74 952 427705 91624 90108166
Drug hypersensitivity 224.90 9.74 3255 425402 460354 89739436
Malignant neoplasm progression 221.88 9.74 114 428543 106756 90093034
Deafness transitory 220.18 9.74 131 428526 1912 90197878
Abdominal pain upper 215.05 9.74 2463 426194 330211 89869579
Musculoskeletal pain 211.27 9.74 1461 427196 169790 90030000
Onychomadesis 208.40 9.74 582 428075 45416 90154374
Memory impairment 206.38 9.74 1618 427039 195626 90004164
Taste disorder 201.98 9.74 696 427961 60850 90138940
Acute kidney injury 195.46 9.74 815 427842 319572 89880218
Joint swelling 190.47 9.74 3391 425266 499909 89699881
Hypotension 189.18 9.74 843 427814 324554 89875236
Neck pain 186.79 9.74 1046 427611 112917 90086873
Dislocation of vertebra 182.86 9.74 632 428025 55336 90144454
Platelet count decreased 181.95 9.74 228 428429 136741 90063049
Wheezing 180.42 9.74 1820 426837 236260 89963530
Night sweats 180.28 9.74 1134 427523 127632 90072158
Bradycardia 176.21 9.74 88 428569 83759 90116031
Urticaria 174.04 9.74 2251 426406 310483 89889307
Folliculitis 173.46 9.74 1600 427057 202753 89997037
Gastrointestinal pain 171.00 9.74 237 428420 10969 90188821
Myelosuppression 170.63 9.74 25 428632 53566 90146224
Dry mouth 169.51 9.74 1467 427190 182592 90017198
Irritable bowel syndrome 167.47 9.74 1607 427050 205841 89993949
Back injury 166.06 9.74 542 428115 46080 90153710
Pain in extremity 161.09 9.74 3009 425648 447520 89752270
Sleep disorder 160.32 9.74 1535 427122 196495 90003295
Blood cholesterol increased 159.91 9.74 1595 427062 206417 89993373
Constipation 159.60 9.74 732 427925 279663 89920127
Nail disorder 157.76 9.74 625 428032 58442 90141348
Polyarthritis 157.69 9.74 299 428358 18051 90181739
Arthropathy 156.81 9.74 2518 426139 363724 89836066
Renal impairment 155.75 9.74 161 428496 105260 90094530
Drug tolerance 155.28 9.74 293 428364 17623 90182167
White blood cell count decreased 151.47 9.74 355 428302 166754 90033036
Duodenal ulcer perforation 148.12 9.74 1650 427007 219638 89980152
Joint destruction 144.47 9.74 240 428417 13047 90186743
Hypercholesterolaemia 142.75 9.74 891 427766 100001 90099789
Dehydration 142.64 9.74 458 428199 193989 90005801
Helicobacter infection 142.63 9.74 1671 426986 225179 89974611
Swollen joint count increased 142.60 9.74 958 427699 110248 90089542
Leukopenia 141.90 9.74 160 428497 100550 90099240
Lung disorder 140.80 9.74 1200 427457 148683 90051107
Lower respiratory tract infection 139.73 9.74 1805 426852 248854 89950936
Neuropathy peripheral 136.51 9.74 276 428381 136694 90063096
Epilepsy 136.33 9.74 757 427900 81449 90118341
Drug intolerance 134.84 9.74 2914 425743 444677 89755113
Muscle injury 131.64 9.74 1346 427311 175308 90024482
Dyspnoea 131.23 9.74 3170 425487 877785 89322005
Gastrooesophageal reflux disease 129.53 9.74 1279 427378 165058 90034732
Neutrophil count decreased 129.23 9.74 90 428567 71442 90128348
Osteoarthritis 128.05 9.74 1453 427204 194277 90005513
Onychomycosis 124.65 9.74 425 428232 36951 90162839
Prescribed overdose 123.36 9.74 838 427819 96787 90103003
Renal failure 123.01 9.74 273 428384 130734 90069056
Colitis 122.43 9.74 91 428566 69851 90129939
Cardiac failure congestive 122.18 9.74 173 428484 98521 90101269
Pyrexia 122.07 9.74 2295 426362 658190 89541600
Shoulder arthroplasty 121.97 9.74 123 428534 4043 90195747
Intentional product use issue 120.92 9.74 1562 427095 215330 89984460
Respiratory failure 120.25 9.74 236 428421 118182 90081608
Body height below normal 120.12 9.74 92 428565 2076 90197714
Off label use 118.73 9.74 4147 424510 1098105 89101685
Pulmonary fibrosis 115.20 9.74 887 427770 106616 90093174
Finger deformity 114.96 9.74 380 428277 32517 90167273
Seizure 114.39 9.74 356 428301 152273 90047517
Peripheral swelling 113.85 9.74 2656 426001 410450 89789340
Adjustment disorder with depressed mood 113.77 9.74 551 428106 56202 90143588
Rheumatoid arthritis 113.73 9.74 2375 426282 360239 89839551
Drug abuse 113.66 9.74 133 428524 82214 90117576
Human antichimeric antibody positive 112.83 9.74 82 428575 1704 90198086
Amnesia 112.25 9.74 888 427769 107617 90092173
Arthralgia 111.19 9.74 4619 424038 773903 89425887
Premature delivery 110.57 9.74 24 428633 38738 90161052
Pericarditis 110.56 9.74 1844 426813 268307 89931483
Multiple organ dysfunction syndrome 109.53 9.74 97 428560 68239 90131551
Rheumatoid nodule 109.50 9.74 273 428384 19893 90179897
Foot operation 109.36 9.74 171 428486 8830 90190960
Deep vein thrombosis postoperative 105.62 9.74 634 428023 70175 90129615
Hypoglycaemia 105.07 9.74 105 428552 69743 90130047
Anti-cyclic citrullinated peptide antibody positive 102.37 9.74 1629 427028 234804 89964986
Drug resistance 102.22 9.74 12 428645 30437 90169353
Cytomegalovirus infection 101.58 9.74 6 428651 26596 90173194
Hypomagnesaemia 99.57 9.74 23 428634 35565 90164225
Cytokine release syndrome 99.13 9.74 9 428648 27964 90171826
Dyspepsia 98.88 9.74 1399 427258 196761 90003029
Orthostatic hypotension 98.83 9.74 37 428620 41790 90158000
Ill-defined disorder 98.22 9.74 1320 427337 183571 90016219
Atrial fibrillation 97.76 9.74 315 428342 133296 90066494
Macular degeneration 97.74 9.74 29 428628 37941 90161849
Gamma-glutamyltransferase increased 97.67 9.74 29 428628 37923 90161867
Psoriasis 97.58 9.74 1099 427558 146655 90053135
Cerebrovascular accident 96.96 9.74 282 428375 123251 90076539
Product dose omission issue 95.01 9.74 901 427756 290786 89909004
Sciatica 94.29 9.74 810 427847 100572 90099218
Cardiac arrest 94.20 9.74 224 428433 104711 90095079
Syncope 94.14 9.74 317 428340 132346 90067444
Paraesthesia 93.52 9.74 1684 426973 248642 89951148
Foetal exposure during pregnancy 93.50 9.74 43 428614 42932 90156858
Liver function test increased 93.07 9.74 704 427953 84151 90115639
Blood creatinine increased 92.96 9.74 214 428443 101172 90098618
Oedema 92.81 9.74 1396 427261 198899 90000891
Hepatic cytolysis 92.66 9.74 17 428640 30899 90168891
Device expulsion 91.97 9.74 39 428618 40847 90158943
Hyperkalaemia 91.74 9.74 103 428554 64861 90134929
Therapy non-responder 90.35 9.74 1017 427640 135687 90064103
Posterior reversible encephalopathy syndrome 88.58 9.74 4 428653 22335 90177455
Disability 88.55 9.74 405 428252 40340 90159450
Rheumatoid factor positive 87.30 9.74 1216 427441 170434 90029356
Toxicity to various agents 87.12 9.74 905 427752 286941 89912849
Joint laxity 87.03 9.74 83 428574 2545 90197245
Impaired work ability 87.00 9.74 244 428413 19082 90180708
Ulcer haemorrhage 86.64 9.74 298 428359 26023 90173767
Ascites 86.32 9.74 60 428597 47680 90152110
Systemic lupus erythematosus rash 85.94 9.74 79 428578 2310 90197480
Electrocardiogram QT prolonged 85.78 9.74 131 428526 72325 90127465
Balance disorder 85.74 9.74 209 428448 96871 90102919
Cardiospasm 85.27 9.74 93 428564 3353 90196437
Road traffic accident 83.96 9.74 828 427829 106798 90092992
X-ray abnormal 83.26 9.74 430 428227 44994 90154796
Dysphagia 82.63 9.74 264 428393 112014 90087776
Prescribed underdose 82.61 9.74 623 428034 74396 90125394
Product label confusion 82.58 9.74 267 428390 22583 90177207
Product quality issue 82.48 9.74 650 428007 78675 90121115
Palmoplantar keratoderma 82.20 9.74 92 428565 3415 90196375
Nerve injury 82.20 9.74 170 428487 10936 90188854
Exposure during pregnancy 82.15 9.74 726 427931 237684 89962106
Hand deformity 80.81 9.74 1903 426754 294459 89905331
Blister 80.81 9.74 1673 426984 253325 89946465
Subcutaneous drug absorption impaired 80.64 9.74 190 428467 13355 90186435
Adverse reaction 80.62 9.74 316 428341 29396 90170394
Mucosal inflammation 79.60 9.74 93 428564 57532 90142258
Hypoxia 79.07 9.74 138 428519 72261 90127529
Neoplasm progression 79.00 9.74 57 428600 44429 90155361
Loose body in joint 78.79 9.74 60 428597 1342 90198448
Hepatic function abnormal 77.49 9.74 63 428594 46225 90153565
Pulmonary hypertension 77.47 9.74 53 428604 42470 90157320
Depression 77.36 9.74 1915 426742 298686 89901104
Urinary tract infection 77.30 9.74 1000 427657 304632 89895158
Lower limb fracture 76.85 9.74 675 427982 84338 90115452
Therapeutic product effect decreased 76.80 9.74 1786 426871 275785 89924005
Encephalopathy 76.77 9.74 64 428593 46380 90153410
Autoimmune disorder 76.60 9.74 623 428034 76121 90123669
Arthritis 75.12 9.74 1160 427497 166155 90033635
Pruritus genital 75.01 9.74 100 428557 4458 90195332
Swelling 74.67 9.74 2549 426108 416509 89783281
Infusion site reaction 73.88 9.74 228 428429 18811 90180979
Agranulocytosis 73.13 9.74 37 428620 34965 90164825
Musculoskeletal disorder 72.99 9.74 248 428409 21521 90178269
Functional gastrointestinal disorder 72.70 9.74 104 428553 4958 90194832
Bone marrow failure 72.05 9.74 31 428626 32190 90167600
Toothache 70.84 9.74 249 428408 21981 90177809
Muscle spasms 70.69 9.74 1624 427033 250259 89949531
Metastases to liver 70.59 9.74 24 428633 28783 90171007
Drug reaction with eosinophilia and systemic symptoms 70.58 9.74 59 428598 42699 90157091
Stomatitis 70.08 9.74 1748 426909 272950 89926840
Hyperglycaemia 69.61 9.74 83 428574 50887 90148903
Sleep terror 69.00 9.74 95 428562 4369 90195421
Cerebral haemorrhage 68.46 9.74 39 428618 34483 90165307
Osteonecrosis of jaw 68.27 9.74 51 428606 39052 90160738
Wrong technique in product usage process 68.11 9.74 148 428509 71423 90128367
General symptom 67.81 9.74 187 428470 14481 90185309
Creatinine renal clearance decreased 67.19 9.74 6 428651 18893 90180897
Wheelchair user 67.07 9.74 127 428530 7658 90192132
Multiple fractures 66.85 9.74 143 428514 9419 90190371
Sopor 66.85 9.74 17 428640 24627 90175163
Seronegative arthritis 66.75 9.74 214 428443 18020 90181770
Ear infection 66.73 9.74 561 428096 69214 90130576
Respiratory distress 66.46 9.74 52 428605 38894 90160896
Foot deformity 66.02 9.74 496 428161 59155 90140635
Tension headache 64.08 9.74 122 428535 7387 90192403
Neurotoxicity 63.92 9.74 12 428645 21455 90178335
Lactic acidosis 63.91 9.74 87 428570 50376 90149414
International normalised ratio increased 63.61 9.74 78 428579 47238 90152552
Premature baby 63.02 9.74 20 428637 25057 90174733
Mycotic allergy 62.57 9.74 47 428610 1029 90198761
Immunisation 62.35 9.74 64 428593 2149 90197641
Psychotic disorder 62.33 9.74 35 428622 31195 90168595
Dizziness 61.95 9.74 3393 425264 585891 89613899
Lip swelling 61.65 9.74 352 428305 38258 90161532
Pseudoporphyria 61.63 9.74 29 428628 253 90199537
Live birth 61.40 9.74 608 428049 78499 90121291
Gastric ulcer 61.26 9.74 275 428382 27173 90172617
Blood creatine phosphokinase increased 61.19 9.74 43 428614 33980 90165810
Fall 60.89 9.74 1774 426883 480036 89719754
Foetal death 60.82 9.74 12 428645 20711 90179079
Erythema 59.83 9.74 745 427912 228501 89971289
Tremor 59.80 9.74 451 428206 152722 90047068
Cardio-respiratory arrest 59.72 9.74 131 428526 63009 90136781
Angioedema 59.61 9.74 517 428140 64359 90135431
Acute respiratory failure 59.56 9.74 69 428588 42849 90156941
Hypervolaemia 59.44 9.74 41 428616 32716 90167074
Pulmonary arterial hypertension 58.87 9.74 25 428632 26162 90173628
Haematoma 58.38 9.74 59 428598 38989 90160801
Rash vesicular 58.13 9.74 204 428453 17993 90181797
Therapy interrupted 57.97 9.74 92 428565 50016 90149774
Pustular psoriasis 57.54 9.74 206 428451 18350 90181440
Aspartate aminotransferase increased 57.15 9.74 271 428386 102666 90097124
Walking aid user 56.88 9.74 324 428333 35182 90164608
Red blood cell sedimentation rate increased 56.63 9.74 619 428038 81976 90117814
Palmar-plantar erythrodysaesthesia syndrome 56.52 9.74 31 428626 27992 90171798
Tenosynovitis stenosans 56.45 9.74 81 428576 3872 90195918
Blood bilirubin increased 56.01 9.74 74 428583 43396 90156394
Wound 55.71 9.74 1850 426807 301130 89898660
Gastrointestinal disorder 55.60 9.74 1599 427058 255088 89944702
Myelodysplastic syndrome 55.59 9.74 15 428642 20888 90178902
C-reactive protein 55.46 9.74 294 428363 31073 90168717
Full blood count abnormal 55.06 9.74 55 428602 36542 90163248
Pericardial effusion 54.67 9.74 56 428601 36777 90163013
Lupus vulgaris 54.66 9.74 383 428274 44676 90155114
Acute myeloid leukaemia 54.54 9.74 15 428642 20625 90179165
Electrolyte imbalance 54.45 9.74 22 428635 23723 90176067
Muscular weakness 54.45 9.74 1321 427336 205345 89994445
Device related infection 54.26 9.74 27 428630 25759 90174031
Cholestasis 54.10 9.74 55 428602 36244 90163546
Cardiogenic shock 53.98 9.74 24 428633 24444 90175346
Adrenal insufficiency 53.97 9.74 282 428375 29639 90170151
Proctitis 53.83 9.74 5 428652 15254 90184536
Contraindicated product administered 53.66 9.74 1934 426723 318205 89881585
Pneumonia 53.61 9.74 2469 426188 635590 89564200
Arrhythmia 53.59 9.74 73 428584 42259 90157531
Drug tolerance decreased 53.33 9.74 296 428361 31834 90167956
Cholecystitis chronic 53.32 9.74 133 428524 9693 90190097
Plasma cell myeloma 53.12 9.74 69 428588 40759 90159031
Neovascularisation 53.07 9.74 51 428606 1579 90198211
Pulmonary oedema 52.98 9.74 136 428521 61944 90137846
Epistaxis 52.78 9.74 215 428442 84910 90114880
Breast cancer stage II 52.44 9.74 316 428341 35018 90164772
Intestinal obstruction 52.28 9.74 59 428598 37072 90162718
Cough 52.15 9.74 1337 427320 367625 89832165
Glossodynia 51.77 9.74 1935 426722 319844 89879946
Carotid artery occlusion 51.62 9.74 101 428556 6241 90193549
Chronic sinusitis 51.49 9.74 24 428633 23778 90176012
Antibody test positive 51.38 9.74 67 428590 2922 90196868
Blood alkaline phosphatase increased 51.27 9.74 93 428564 47986 90151804
Liver disorder 50.37 9.74 830 427827 120439 90079351
Osteoporosis 50.33 9.74 687 427970 95844 90103946
Synovial fluid analysis 49.75 9.74 64 428593 2754 90197036
Blood calcium decreased 49.38 9.74 42 428615 30140 90169650
Alanine aminotransferase increased 49.30 9.74 342 428315 117996 90081794
Nephrolithiasis 49.26 9.74 399 428258 48686 90151104
Nasopharyngitis 48.82 9.74 2374 426283 404730 89795060
Obstructive airways disorder 48.80 9.74 31 428626 25838 90173952
Hypothyroidism 48.80 9.74 112 428545 53015 90146775
Hepatotoxicity 48.59 9.74 89 428568 45753 90154037
Coma 47.88 9.74 179 428478 72453 90127337
Weight increased 47.81 9.74 2426 426231 415501 89784289
Diabetic ketoacidosis 47.79 9.74 28 428629 24379 90175411
Bacteraemia 47.46 9.74 23 428634 22277 90177513
Hypoalbuminaemia 47.09 9.74 9 428648 15888 90183902
Atrial tachycardia 47.07 9.74 94 428563 5896 90193894
Depressed level of consciousness 46.92 9.74 181 428476 72603 90127187
Eosinophilia 46.32 9.74 40 428617 28493 90171297
Pemphigus 46.14 9.74 1938 426719 324926 89874864
Cerebral infarction 46.03 9.74 35 428622 26561 90173229
Hypokalaemia 45.69 9.74 398 428259 130718 90069072
Porphyria acute 45.43 9.74 187 428470 17788 90182002
Back disorder 45.15 9.74 240 428417 25391 90174399
Urosepsis 45.03 9.74 22 428635 21210 90178580
Juvenile idiopathic arthritis 44.81 9.74 73 428584 3904 90195886
Hallucination, visual 44.50 9.74 27 428630 23065 90176725
Circulatory collapse 44.10 9.74 32 428625 24872 90174918
Eye injury 43.72 9.74 133 428524 10887 90188903
Right ventricular failure 43.71 9.74 18 428639 19187 90180603
Sedation complication 43.50 9.74 13 428644 16931 90182859
Blood pressure decreased 43.46 9.74 194 428463 74701 90125089
Metastases to lung 43.43 9.74 11 428646 15980 90183810
Intestinal diaphragm disease 42.88 9.74 19 428638 142 90199648
Therapy cessation 42.78 9.74 66 428591 36295 90163495
Drug specific antibody 42.71 9.74 56 428601 2456 90197334
Dyspnoea exertional 42.10 9.74 187 428470 72101 90127689
Oral candidiasis 42.06 9.74 64 428593 35391 90164399
Pneumocystis jirovecii pneumonia 42.04 9.74 25 428632 21591 90178199
Temperature regulation disorder 41.63 9.74 9 428648 14570 90185220
Aggression 41.37 9.74 39 428618 26629 90173161
Myositis 41.20 9.74 224 428433 23904 90175886
Metastases to bone 41.11 9.74 36 428621 25469 90174321
Nodule 41.11 9.74 241 428416 26445 90173345
Radiculopathy 41.06 9.74 18 428639 18487 90181303
Acute respiratory distress syndrome 41.03 9.74 45 428612 28641 90171149
Full blood count decreased 40.91 9.74 48 428609 29641 90170149
Injection site reaction 40.77 9.74 637 428020 91443 90108347
Bronchiectasis 40.45 9.74 28 428629 22302 90177488
Tenosynovitis 40.39 9.74 156 428501 14411 90185379
Vaginal discharge 40.03 9.74 21 428636 19443 90180347
Sedation 39.99 9.74 107 428550 48064 90151726
Joint effusion 39.95 9.74 192 428465 19518 90180272
Pleural effusion 39.89 9.74 338 428319 111653 90088137
Aphasia 39.53 9.74 90 428567 42722 90157068
Generalised tonic-clonic seizure 39.51 9.74 65 428592 34838 90164952
Pulmonary embolism 38.85 9.74 413 428244 130407 90069383
Cytopenia 38.68 9.74 17 428640 17432 90182358
Chest discomfort 38.63 9.74 443 428214 137922 90061868
Haematochezia 38.60 9.74 188 428469 70725 90129065
Lymphopenia 38.47 9.74 31 428626 22850 90176940
Insomnia 38.37 9.74 1937 426720 331537 89868253
Tachycardia 38.32 9.74 520 428137 157153 90042637
Polyneuropathy 38.13 9.74 22 428635 19319 90180471
Left ventricular dysfunction 38.13 9.74 11 428646 14658 90185132
Pancreatitis acute 38.07 9.74 58 428599 32057 90167733
Pain 37.89 9.74 5319 423338 991022 89208768
Enthesopathy 37.78 9.74 114 428543 9290 90190500
Delirium 37.50 9.74 698 427959 103661 90096129
Abdominal discomfort 37.45 9.74 2680 425977 474648 89725142
Schizophrenia 37.29 9.74 12 428645 14902 90184888
Lymphocyte count decreased 37.19 9.74 68 428589 34982 90164808
Female genital tract fistula 37.16 9.74 19 428638 17849 90181941
Vascular device infection 37.08 9.74 6 428651 11946 90187844
Bronchopulmonary aspergillosis 37.02 9.74 5 428652 11393 90188397
Cardiotoxicity 36.99 9.74 5 428652 11384 90188406
Staphylococcal infection 36.97 9.74 112 428545 48327 90151463
Unresponsive to stimuli 36.96 9.74 78 428579 38043 90161747
Limb discomfort 36.91 9.74 307 428350 37753 90162037
Swelling face 36.86 9.74 565 428092 80787 90119003
Infection 36.81 9.74 2079 426578 360015 89839775
Blood lactate dehydrogenase increased 36.73 9.74 41 428616 25891 90173899
Premature labour 36.72 9.74 9 428648 13367 90186423
Oedema peripheral 36.57 9.74 934 427723 256981 89942809
Somnolence 36.49 9.74 733 427924 208351 89991439
Status epilepticus 36.46 9.74 22 428635 18852 90180938
Abortion spontaneous 36.43 9.74 132 428525 53924 90145866
Femur fracture 36.15 9.74 355 428302 45727 90154063
Bunion operation 35.98 9.74 38 428619 1320 90198470
Choanal stenosis 35.96 9.74 11 428646 22 90199768
Chills 35.90 9.74 425 428232 131556 90068234
Oxygen saturation decreased 35.81 9.74 330 428327 107153 90092637
Cyanosis 35.77 9.74 24 428633 19431 90180359
Underdose 35.73 9.74 402 428255 53615 90146175
Enterocolitis 35.55 9.74 4 428653 10486 90189304
Hepatic failure 35.49 9.74 85 428572 39643 90160147
Scleritis 35.40 9.74 77 428580 5131 90194659
Malnutrition 35.34 9.74 22 428635 18536 90181254
Red blood cell sedimentation rate 35.30 9.74 72 428585 4586 90195204
Sinus bradycardia 35.29 9.74 18 428639 16934 90182856
Device dislocation 35.29 9.74 59 428598 31423 90168367
Mental status changes 35.04 9.74 102 428555 44577 90155213
Blood potassium increased 35.03 9.74 28 428629 20721 90179069
Blood urea increased 35.03 9.74 56 428601 30357 90169433
Arthrodesis 34.90 9.74 56 428601 2956 90196834
Systemic lupus erythematosus 34.90 9.74 2068 426589 359828 89839962
Ankle arthroplasty 34.69 9.74 54 428603 2777 90197013
Hypocholesterolaemia 34.69 9.74 87 428570 6362 90193428
Blood glucose increased 34.58 9.74 286 428371 94960 90104830
Complication associated with device 34.43 9.74 25 428632 19424 90180366
Rales 34.18 9.74 16 428641 15811 90183979
Acute pulmonary oedema 34.17 9.74 3 428654 9577 90190213
Drug level increased 34.02 9.74 49 428608 27713 90172077
Pneumonitis 33.80 9.74 102 428555 44068 90155722
Anosmia 33.73 9.74 113 428544 9735 90190055
Tumour lysis syndrome 33.71 9.74 6 428651 11146 90188644
Ischaemic stroke 33.70 9.74 33 428624 22133 90177657
Hip arthroplasty 33.66 9.74 527 428130 75681 90124109
Cardiomyopathy 33.20 9.74 28 428629 20178 90179612
Metastases to central nervous system 33.12 9.74 21 428636 17521 90182269
Stress cardiomyopathy 32.94 9.74 11 428646 13344 90186446
Transfusion 32.93 9.74 21 428636 17467 90182323
Clostridium difficile colitis 32.86 9.74 47 428610 26659 90173131
Clostridium difficile infection 32.81 9.74 77 428580 36168 90163622
Caesarean section 32.73 9.74 24 428633 18553 90181237
Rhabdomyolysis 32.70 9.74 128 428529 51128 90148662
Ejection fraction decreased 32.50 9.74 46 428611 26207 90173583
Bronchospasm 32.46 9.74 30 428627 20679 90179111
Injection site pain 32.43 9.74 602 428055 173097 90026693
Bone density decreased 32.34 9.74 165 428492 17180 90182610
Ulcer 32.30 9.74 266 428391 32616 90167174
Myoclonus 32.19 9.74 26 428631 19142 90180648
Diabetes mellitus inadequate control 31.81 9.74 25 428632 18659 90181131
Rheumatoid lung 31.78 9.74 64 428593 4039 90195751
Myocarditis 31.32 9.74 13 428644 13793 90185997
Cartilage atrophy 31.29 9.74 16 428641 170 90199620
Bone pain 31.09 9.74 169 428488 61814 90137976
Drug-induced liver injury 31.05 9.74 600 428057 89718 90110072
Ileus 30.98 9.74 20 428637 16526 90183264
Hemiparesis 30.94 9.74 65 428592 31754 90168036
Synovial disorder 30.84 9.74 54 428603 3064 90196726
Hyperthyroidism 30.55 9.74 25 428632 18285 90181505
Blood albumin decreased 30.53 9.74 21 428636 16782 90183008
Shock 30.39 9.74 56 428601 28722 90171068
Epstein-Barr virus infection 30.34 9.74 6 428651 10338 90189452
Cardiac disorder 30.25 9.74 152 428505 56720 90143070
Short stature 30.25 9.74 31 428626 1039 90198751
Soft tissue injury 30.07 9.74 43 428614 2049 90197741
Gastric ulcer haemorrhage 30.00 9.74 73 428584 5238 90194552
General physical health deterioration 29.96 9.74 2006 426651 353109 89846681
Respiratory tract infection 29.68 9.74 161 428496 58917 90140873
Oliguria 29.45 9.74 7 428650 10617 90189173
Dementia 29.35 9.74 42 428615 23819 90175971
Pain of skin 29.30 9.74 152 428505 15930 90183860
Aplastic anaemia 29.30 9.74 13 428644 13256 90186534
Pemphigoid 29.22 9.74 4 428653 9022 90190768
Progressive multifocal leukoencephalopathy 29.20 9.74 19 428638 15636 90184154
Parkinsonism 29.19 9.74 15 428642 14050 90185740
Restlessness 29.15 9.74 80 428577 35640 90164150
Transaminases increased 29.10 9.74 85 428572 37107 90162683
Knee arthroplasty 29.07 9.74 554 428103 82628 90117162
Blood sodium decreased 28.92 9.74 54 428603 27559 90172231
Lymphadenopathy 28.76 9.74 115 428542 45660 90154130
Synovial cyst 28.71 9.74 121 428536 11631 90188159
Myopathy 28.68 9.74 14 428643 13504 90186286
Faecaloma 28.67 9.74 7 428650 10424 90189366
No adverse event 28.54 9.74 196 428461 67786 90132004
Laryngitis 28.44 9.74 366 428291 50387 90149403
Unevaluable event 28.37 9.74 148 428509 54700 90145090
Toxic skin eruption 28.28 9.74 20 428637 15754 90184036
Generalised oedema 28.24 9.74 29 428628 19024 90180766
Hepatic encephalopathy 28.12 9.74 15 428642 13757 90186033
Overdose 28.08 9.74 551 428106 157158 90042632
Blood potassium decreased 28.07 9.74 123 428534 47604 90152186
Diarrhoea 27.80 9.74 3957 424700 935233 89264557
Osteoporotic fracture 27.72 9.74 66 428591 4670 90195120
Proteinuria 27.67 9.74 42 428615 23249 90176541
Sleep disorder due to general medical condition, insomnia type 27.65 9.74 801 427856 127893 90071897
Hypertensive crisis 27.59 9.74 26 428631 17758 90182032
Urinary retention 27.58 9.74 89 428568 37655 90162135
Pneumonia aspiration 27.57 9.74 100 428557 40840 90158950
Torsade de pointes 27.55 9.74 19 428638 15163 90184627
Accidental exposure to product 27.54 9.74 105 428552 42261 90157529
Purpura 27.48 9.74 18 428639 14760 90185030
Subdural haematoma 27.43 9.74 23 428634 16622 90183168
Disseminated intravascular coagulation 27.40 9.74 37 428620 21501 90178289
Neuroleptic malignant syndrome 27.25 9.74 19 428638 15077 90184713
Sacroiliitis 27.12 9.74 61 428596 4158 90195632
Acute myocardial infarction 27.11 9.74 80 428577 34810 90164980
Altered state of consciousness 26.96 9.74 69 428588 31463 90168327
Rash maculo-papular 26.90 9.74 101 428556 40832 90158958
Fracture delayed union 26.89 9.74 45 428612 2461 90197329
Angina pectoris 26.80 9.74 95 428562 39065 90160725
Iritis 26.78 9.74 56 428601 3630 90196160
Myalgia 26.78 9.74 627 428030 174498 90025292
Residual urine volume increased 26.50 9.74 12 428645 95 90199695
Dysstasia 26.43 9.74 206 428451 24846 90174944
Gastroenteritis viral 26.38 9.74 239 428418 30116 90169674
Medication overuse headache 26.36 9.74 34 428623 1467 90198323
COVID-19 26.24 9.74 603 428054 168240 90031550
Chronic kidney disease 26.21 9.74 135 428522 50056 90149734
Hospitalisation 26.13 9.74 437 428220 127663 90072127
Pneumonia viral 26.12 9.74 5 428652 8818 90190972
Lipase increased 25.96 9.74 10 428647 11101 90188689
Diabetes mellitus 25.79 9.74 190 428467 64685 90135105
Gastric ulcer perforation 25.77 9.74 32 428625 1328 90198462
Pre-eclampsia 25.72 9.74 10 428647 11038 90188752
Facial pain 25.71 9.74 127 428530 13055 90186735
Hepatic enzyme 25.57 9.74 69 428588 5275 90194515
Rhinitis allergic 25.51 9.74 25 428632 16760 90183030
Labelled drug-drug interaction medication error 25.48 9.74 19 428638 14563 90185227
COVID-19 pneumonia 25.46 9.74 29 428628 18148 90181642
Dyskinesia 25.43 9.74 88 428569 36446 90163344
Haemorrhage 25.32 9.74 208 428449 69161 90130629
Pseudomonas infection 25.17 9.74 20 428637 14845 90184945
Fear of injection 25.11 9.74 93 428564 8422 90191368
Bone density increased 25.09 9.74 26 428631 883 90198907
Enterococcal infection 25.05 9.74 8 428649 9983 90189807
Hepatocellular injury 25.05 9.74 63 428594 28895 90170895
Metastases to lymph nodes 24.96 9.74 12 428645 11677 90188113
Tendonitis 24.95 9.74 180 428477 21192 90178598
Ventricular fibrillation 24.93 9.74 18 428639 14026 90185764
Haemorrhage intracranial 24.93 9.74 21 428636 15141 90184649
Vertigo 24.72 9.74 211 428446 69600 90130190
Hypovolaemia 24.71 9.74 14 428643 12417 90187373
Coeliac disease 24.70 9.74 321 428336 44289 90155501
Pallor 24.66 9.74 81 428576 34084 90165706
Head injury 24.60 9.74 71 428586 31117 90168673
Cataract 24.60 9.74 220 428437 71872 90127918
Herpes zoster 24.51 9.74 308 428349 94336 90105454
Haematuria 24.42 9.74 84 428573 34853 90164937
Hypomania 24.40 9.74 6 428651 8891 90190899
Inappropriate antidiuretic hormone secretion 24.32 9.74 34 428623 19471 90180319
Ovarian germ cell teratoma benign 24.20 9.74 13 428644 154 90199636
Pineal gland cyst 24.04 9.74 14 428643 196 90199594
Neutrophil count increased 23.98 9.74 34 428623 19356 90180434
Respiratory tract congestion 23.92 9.74 216 428441 27194 90172596
Injection site erythema 23.88 9.74 325 428332 98177 90101613
Splenomegaly 23.68 9.74 16 428641 12908 90186882
Blood pressure increased 23.65 9.74 731 427926 196486 90003304
Spondyloarthropathy 23.52 9.74 29 428628 1195 90198595
Product prescribing error 23.51 9.74 69 428588 30076 90169714
Hyperbilirubinaemia 23.28 9.74 19 428638 13917 90185873
Cognitive disorder 23.16 9.74 213 428444 69194 90130596
Cytomegalovirus viraemia 23.11 9.74 4 428653 7582 90192208
Jaw clicking 23.09 9.74 11 428646 99 90199691
Unintentional medical device removal 23.04 9.74 3 428654 7027 90192763
Drug withdrawal syndrome 22.94 9.74 65 428592 28658 90171132
Eosinophil count increased 22.91 9.74 17 428640 13064 90186726
Paraesthesia oral 22.89 9.74 75 428582 31584 90168206
Disorientation 22.84 9.74 119 428538 43995 90155795
Hypophosphataemia 22.72 9.74 22 428635 14832 90184958
Small intestinal obstruction 22.71 9.74 41 428616 21193 90178597
Atrioventricular block complete 22.64 9.74 9 428648 9802 90189988
Adverse event 22.59 9.74 721 427936 116697 90083093
Serum amyloid A protein increased 22.53 9.74 22 428635 695 90199095
Anti-cyclic citrullinated peptide antibody 22.49 9.74 212 428445 27009 90172781
Duodenal ulcer haemorrhage 22.40 9.74 42 428615 2514 90197276
Drug effective for unapproved indication 22.38 9.74 5 428652 7913 90191877
Neutropenic sepsis 22.21 9.74 32 428625 18098 90181692
Dialysis 22.17 9.74 13 428644 11316 90188474
Clear cell renal cell carcinoma 22.02 9.74 32 428625 1548 90198242
Gastroenteritis 22.01 9.74 68 428589 29161 90170629
Flushing 21.80 9.74 291 428366 88200 90111590
Product storage error 21.72 9.74 39 428618 20202 90179588
Hyperuricaemia 21.70 9.74 3 428654 6716 90193074
Antinuclear antibody positive 21.69 9.74 94 428563 9147 90190643
Food allergy 21.60 9.74 56 428601 25422 90174368
Escherichia infection 21.58 9.74 26 428631 15869 90183921
Diffuse large B-cell lymphoma 21.54 9.74 7 428650 8638 90191152
Renal function test abnormal 21.45 9.74 4 428653 7187 90192603
Abnormal loss of weight 21.37 9.74 76 428581 6747 90193043
Skin haemorrhage 21.36 9.74 43 428614 21337 90178453
Cervicogenic headache 21.31 9.74 13 428644 199 90199591
Treatment noncompliance 21.29 9.74 150 428507 51577 90148213
Hypogammaglobulinaemia 21.25 9.74 12 428645 10662 90189128
Tachypnoea 21.16 9.74 43 428614 21266 90178524
Chronic obstructive pulmonary disease 21.14 9.74 235 428422 73594 90126196
Asphyxia 21.09 9.74 4 428653 7099 90192691
Staphylococcal sepsis 21.02 9.74 9 428648 9374 90190416
Foetal growth restriction 21.01 9.74 9 428648 9371 90190419
Brain oedema 20.99 9.74 31 428626 17354 90182436
Fatigue 20.95 9.74 4990 423667 1149033 89050757
Supraventricular tachycardia 20.85 9.74 28 428629 16308 90183482
Hallucination, auditory 20.78 9.74 27 428630 15948 90183842
Drug level decreased 20.76 9.74 10 428647 9720 90190070
Swollen tongue 20.75 9.74 319 428338 45637 90154153
Sudden death 20.68 9.74 13 428644 10896 90188894
Breast cancer female 20.58 9.74 24 428633 14862 90184928
Pleuritic pain 20.55 9.74 101 428556 10360 90189430
Infusion related reaction 20.55 9.74 2262 426395 414518 89785272
Joint ankylosis 20.55 9.74 28 428629 1275 90198515
Lethargy 20.54 9.74 195 428462 62944 90136846
Glaucoma 20.51 9.74 42 428615 20713 90179077
Hunger 20.47 9.74 73 428584 6490 90193300
Hepatic enzyme increased 20.37 9.74 1976 426681 358760 89841030
Condition aggravated 20.36 9.74 3161 425496 592384 89607406
Drug use disorder 20.36 9.74 7 428650 8336 90191454
Dystonia 20.30 9.74 30 428627 16789 90183001
Serum sickness-like reaction 20.29 9.74 19 428638 569 90199221
Malaise 20.12 9.74 3111 425546 582875 89616915
Disability assessment scale score increased 20.07 9.74 52 428605 3879 90195911
Exostosis 20.00 9.74 358 428299 52776 90147014
Wrist deformity 19.91 9.74 46 428611 3192 90196598
Bone erosion 19.87 9.74 357 428300 52664 90147126
Blood pressure measurement 19.84 9.74 16 428641 390 90199400
Hepatitis 19.78 9.74 456 428201 70283 90129507
Lacrimation increased 19.64 9.74 64 428593 26998 90172792
Libido increased 19.63 9.74 32 428625 1712 90198078
Hypothermia 19.57 9.74 27 428630 15548 90184242
Tardive dyskinesia 19.41 9.74 14 428643 10916 90188874
Leukocytosis 19.38 9.74 78 428579 30912 90168878
Limb deformity 19.26 9.74 53 428604 4099 90195691
Disease recurrence 19.25 9.74 102 428555 37551 90162239
Exercise tolerance decreased 19.01 9.74 6 428651 7545 90192245
Peripheral sensory neuropathy 18.99 9.74 10 428647 9240 90190550
Second primary malignancy 18.82 9.74 13 428644 10365 90189425
Acute hepatic failure 18.81 9.74 50 428607 22511 90177279
Oesophageal spasm 18.77 9.74 46 428611 3315 90196475
Quality of life decreased 18.72 9.74 108 428549 11781 90188009
Mitral valve incompetence 18.72 9.74 50 428607 22474 90177316
Candida infection 18.70 9.74 90 428567 33967 90165823
Cardiac murmur 18.69 9.74 36 428621 18158 90181632
Tooth infection 18.66 9.74 161 428496 20009 90179781
Smear cervix abnormal 18.62 9.74 44 428613 3098 90196692
Uveitis 18.60 9.74 134 428523 15769 90184021
Urinary incontinence 18.53 9.74 103 428554 37463 90162327
Allergy to chemicals 18.50 9.74 49 428608 3705 90196085
Hepatic steatosis 18.38 9.74 101 428556 36844 90162946
Endocarditis fibroplastica 18.35 9.74 5 428652 5 90199785
Blood calcium increased 18.28 9.74 18 428639 12040 90187750
Gestational diabetes 18.22 9.74 14 428643 10568 90189222
Hypoacusis 18.11 9.74 69 428588 27781 90172009
Joint injury 18.07 9.74 235 428422 32429 90167361
Rash papular 18.07 9.74 161 428496 20194 90179596
Ovarian hyperstimulation syndrome 18.06 9.74 3 428654 5859 90193931
Nephropathy toxic 18.04 9.74 20 428637 12668 90187122
Renal mass 18.03 9.74 38 428619 2477 90197313
Withdrawal syndrome 17.97 9.74 51 428606 22473 90177317
Duodenal ulcer 17.90 9.74 91 428566 9461 90190329
Gait disturbance 17.79 9.74 1447 427210 259049 89940741
Aspirin-exacerbated respiratory disease 17.74 9.74 19 428638 671 90199119
Feeling jittery 17.68 9.74 129 428528 15242 90184548
Metabolic encephalopathy 17.67 9.74 5 428652 6747 90193043
Anal incontinence 17.66 9.74 31 428626 16199 90183591
Congenital anomaly 17.62 9.74 68 428589 6279 90193511
Glycosylated haemoglobin increased 17.60 9.74 29 428628 15533 90184257
Rash erythematous 17.56 9.74 210 428447 64894 90134896
Gallbladder injury 17.55 9.74 26 428631 1280 90198510
Bradyphrenia 17.54 9.74 7 428650 7605 90192185
Device leakage 17.48 9.74 13 428644 9978 90189812
Alanine aminotransferase abnormal 17.48 9.74 61 428596 5365 90194425
Left ventricular failure 17.46 9.74 5 428652 6695 90193095
Pharyngeal swelling 17.44 9.74 93 428564 9851 90189939
Rib synostosis 17.43 9.74 4 428653 0 90199790
Hypercapnia 17.37 9.74 5 428652 6672 90193118
Aorta hypoplasia 17.35 9.74 11 428646 181 90199609
Cardiovascular disorder 17.35 9.74 23 428634 13469 90186321
Muscle twitching 17.33 9.74 183 428474 24019 90175771
Endocarditis 17.30 9.74 6 428651 7107 90192683
Adenoiditis 17.23 9.74 7 428650 41 90199749
Device malfunction 17.10 9.74 47 428610 20930 90178860
Drug dose omission by device 17.03 9.74 14 428643 10217 90189573
Hypersensitivity 17.02 9.74 2426 426231 452251 89747539
Hypertriglyceridaemia 17.00 9.74 8 428649 7881 90191909
Eczema 16.89 9.74 164 428493 52706 90147084
Skin exfoliation 16.85 9.74 223 428434 67690 90132100
Lung infiltration 16.80 9.74 29 428628 15253 90184537
Premature rupture of membranes 16.78 9.74 3 428654 5555 90194235
Nasal polyps 16.77 9.74 16 428641 10864 90188926
Blood parathyroid hormone decreased 16.72 9.74 107 428550 12109 90187681
Troponin increased 16.71 9.74 23 428634 13258 90186532
Hip fracture 16.69 9.74 90 428567 32987 90166803
Anti-transglutaminase antibody 16.69 9.74 5 428652 9 90199781
Jaundice 16.67 9.74 88 428569 32429 90167361
Bone disorder 16.64 9.74 175 428482 22945 90176845
Bacterial infection 16.63 9.74 56 428601 23388 90176402
Hereditary angioedema 16.63 9.74 12 428645 9353 90190437
Abortion induced 16.62 9.74 19 428638 11869 90187921
Congestive cardiomyopathy 16.56 9.74 7 428650 7347 90192443
Dactylitis 16.56 9.74 48 428609 3825 90195965
Skin lesion 16.55 9.74 106 428551 37259 90162531
Complication of device insertion 16.50 9.74 15 428642 10421 90189369
Inappropriate schedule of product administration 16.48 9.74 562 428095 149371 90050419
Spinal fusion surgery 16.45 9.74 107 428550 12176 90187614
Jejunal ulcer 16.44 9.74 9 428648 111 90199679
Device ineffective 16.40 9.74 12 428645 252 90199538
Delusion 16.40 9.74 25 428632 13815 90185975
Rhinovirus infection 16.39 9.74 4 428653 5959 90193831
Pulmonary congestion 16.38 9.74 152 428505 19281 90180509
Sickle cell anaemia with crisis 16.35 9.74 7 428650 7290 90192500
Device occlusion 16.34 9.74 12 428645 9270 90190520
Haemolysis 16.33 9.74 10 428647 8500 90191290
Loss of consciousness 16.27 9.74 522 428135 139716 90060074
Procedural pain 16.16 9.74 92 428565 33268 90166522
Nystagmus 16.08 9.74 7 428650 7220 90192570
Biliary dyskinesia 16.06 9.74 37 428620 2562 90197228
Tenderness 16.01 9.74 196 428461 26672 90173118
Failure to thrive 15.98 9.74 10 428647 8401 90191389
Cholangitis 15.91 9.74 7 428650 7175 90192615
Hostility 15.90 9.74 34 428623 2239 90197551
Forced expiratory volume decreased 15.76 9.74 4 428653 5804 90193986
Joint stiffness 15.74 9.74 482 428175 77560 90122230
Anal abscess 15.72 9.74 61 428596 5647 90194143
Nervous system disorder 15.72 9.74 51 428606 21542 90178248
Product substitution issue 15.71 9.74 39 428618 17969 90181821
Haematemesis 15.57 9.74 235 428422 33491 90166299
Granuloma skin 15.52 9.74 95 428562 10585 90189205
Amylase increased 15.50 9.74 7 428650 7065 90192725
Fracture 15.48 9.74 53 428604 22023 90177767
Hypernatraemia 15.43 9.74 13 428644 9374 90190416
Haemoglobin decreased 15.35 9.74 618 428039 161338 90038452
Large intestine perforation 15.30 9.74 14 428643 9698 90190092
Liver function test abnormal 15.30 9.74 160 428497 50685 90149105
Aplasia pure red cell 15.26 9.74 3 428654 5191 90194599
Device difficult to use 15.26 9.74 38 428619 17487 90182303
Swollen joint count 15.22 9.74 81 428576 8572 90191218
End stage renal disease 15.19 9.74 11 428646 8560 90191230
Multiple sclerosis relapse 15.17 9.74 166 428491 52139 90147651
Human anti-human antibody test 15.10 9.74 14 428643 414 90199376
Collagen-vascular disease 15.10 9.74 8 428649 92 90199698
Maternal drugs affecting foetus 15.10 9.74 3 428654 5152 90194638
Epidermal necrosis 15.02 9.74 34 428623 2327 90197463
Injection site rash 15.01 9.74 61 428596 24112 90175678
Enteritis 14.97 9.74 16 428641 10305 90189485
Respiratory acidosis 14.95 9.74 10 428647 8109 90191681
Thrombosis 14.90 9.74 250 428407 73001 90126789
Retching 14.83 9.74 44 428613 19115 90180675
Metastases to fallopian tube 14.79 9.74 7 428650 62 90199728
Skin discolouration 14.78 9.74 136 428521 44179 90155611
Spinal compression fracture 14.76 9.74 31 428626 15147 90184643
Ankle impingement 14.69 9.74 5 428652 16 90199774
Pulmonary alveolar haemorrhage 14.69 9.74 5 428652 5993 90193797
IIIrd nerve injury 14.68 9.74 4 428653 4 90199786
Post-traumatic neck syndrome 14.68 9.74 35 428622 2479 90197311
Hodgkin's disease 14.65 9.74 18 428639 739 90199051
Contusion 14.60 9.74 1379 427278 249837 89949953
Visual acuity reduced 14.59 9.74 59 428598 23351 90176439
Paradoxical drug reaction 14.58 9.74 60 428597 5706 90194084
Coronary artery disease 14.58 9.74 96 428561 33527 90166263
Therapeutic response decreased 14.50 9.74 540 428117 89189 90110601
Small for dates baby 14.48 9.74 3 428654 5004 90194786
Face oedema 14.38 9.74 59 428598 23259 90176531
Squamous cell carcinoma 14.27 9.74 16 428641 10085 90189705
Bacterial sepsis 14.27 9.74 3 428654 4952 90194838
Device breakage 14.24 9.74 28 428629 14016 90185774
Poisoning deliberate 14.15 9.74 36 428621 16450 90183340
Bundle branch block left 14.13 9.74 10 428647 7875 90191915
Clostridium test positive 14.13 9.74 4 428653 5397 90194393
Abnormal behaviour 14.12 9.74 57 428600 22571 90177219
Serotonin syndrome 14.10 9.74 113 428544 37774 90162016
Polyuria 14.08 9.74 16 428641 10024 90189766
Retinitis 14.08 9.74 258 428399 38200 90161590
Haemoptysis 14.02 9.74 96 428561 33224 90166566
Blood glucose decreased 14.01 9.74 60 428597 23369 90176421
Leukoencephalopathy 13.93 9.74 3 428654 4870 90194920
Pulseless electrical activity 13.93 9.74 13 428644 8919 90190871
Hepatitis cholestatic 13.90 9.74 12 428645 8549 90191241
Axial spondyloarthritis 13.85 9.74 16 428641 615 90199175
Heparin-induced thrombocytopenia 13.78 9.74 4 428653 5308 90194482
Muscle spasticity 13.78 9.74 104 428553 35218 90164572
Product preparation error 13.70 9.74 17 428640 10244 90189546
Nail psoriasis 13.68 9.74 17 428640 706 90199084
Cellulitis 13.68 9.74 328 428329 91009 90108781
Crepitations 13.67 9.74 80 428577 8772 90191018
Sexual dysfunction 13.65 9.74 3 428654 4801 90194989
Myocardial infarction 13.64 9.74 389 428268 105583 90094207
Hepatic cyst 13.64 9.74 7 428650 6561 90193229
Genital blister 13.59 9.74 9 428648 160 90199630
Myofascial pain syndrome 13.57 9.74 38 428619 2969 90196821
Spondylitis 13.55 9.74 114 428543 14064 90185726
Sternal fracture 13.54 9.74 37 428620 2850 90196940
Body temperature decreased 13.45 9.74 172 428485 23644 90176146
HLA marker study positive 13.43 9.74 10 428647 216 90199574
Fixed eruption 13.42 9.74 27 428630 1703 90198087
Sensitivity to weather change 13.41 9.74 80 428577 8834 90190956
Pneumonia bacterial 13.40 9.74 25 428632 12765 90187025
Autoimmune haemolytic anaemia 13.32 9.74 5 428652 5640 90194150
Cardiac tamponade 13.27 9.74 5 428652 5627 90194163
Anomaly of external ear congenital 13.26 9.74 9 428648 167 90199623
Gingival bleeding 13.22 9.74 32 428625 14871 90184919
Gastric fistula 13.14 9.74 8 428649 122 90199668
Brain natriuretic peptide increased 13.08 9.74 6 428651 5999 90193791
Cerebral ischaemia 13.07 9.74 9 428648 7187 90192603
Treatment failure 13.03 9.74 1635 427022 302293 89897497
Limb operation 12.98 9.74 49 428608 4478 90195312
Hepatic adenoma 12.92 9.74 13 428644 426 90199364
Paranoia 12.86 9.74 26 428631 12882 90186908
Glomerulonephritis minimal lesion 12.80 9.74 12 428645 360 90199430
Electrocardiogram abnormal 12.79 9.74 18 428639 10280 90189510
Dissociation 12.73 9.74 8 428649 6707 90193083
Staphylococcal bacteraemia 12.71 9.74 10 428647 7459 90192331
Mental disorder 12.68 9.74 95 428562 32223 90167567
Stevens-Johnson syndrome 12.67 9.74 84 428573 29292 90170498
Septic shock 12.67 9.74 302 428355 83858 90115932
Vulvovaginal ulceration 12.64 9.74 5 428652 27 90199763
Stillbirth 12.62 9.74 10 428647 7433 90192357
Panic attack 12.62 9.74 73 428584 26292 90173498
Femoral neck fracture 12.60 9.74 18 428639 10215 90189575
Hemiplegia 12.59 9.74 37 428620 16123 90183667
Acquired cystic kidney disease 12.59 9.74 6 428651 54 90199736
Pyelonephritis 12.49 9.74 55 428602 21261 90178529
Device issue 12.47 9.74 85 428572 29452 90170338
Musculoskeletal discomfort 12.45 9.74 153 428504 20838 90178952
Pruritus 12.42 9.74 2314 426343 539211 89660579
Atrioventricular block 12.42 9.74 14 428643 8801 90190989
Substance abuse 12.41 9.74 5 428652 5401 90194389
Escherichia sepsis 12.37 9.74 6 428651 5810 90193980
Acute coronary syndrome 12.37 9.74 20 428637 10793 90188997
Drug level below therapeutic 12.37 9.74 6 428651 5808 90193982
Necrosis 12.36 9.74 8 428649 6602 90193188
Embolism 12.36 9.74 16 428641 9465 90190325
Hydronephrosis 12.34 9.74 25 428632 12377 90187413
Lip oedema 12.31 9.74 49 428608 4590 90195200
Amblyopia 12.27 9.74 11 428646 311 90199479
Hangover 12.27 9.74 30 428627 2159 90197631
Oesophageal pain 12.26 9.74 47 428610 4327 90195463
Presyncope 12.24 9.74 94 428563 31711 90168079
Rash pustular 12.22 9.74 12 428645 8037 90191753
Atrioventricular block second degree 12.21 9.74 3 428654 4449 90195341
Ventricular hypokinesia 12.16 9.74 5 428652 5336 90194454
Haemolytic anaemia 12.14 9.74 23 428634 11674 90188116
Accidental overdose 12.12 9.74 81 428576 28192 90171598
Burning sensation 12.12 9.74 219 428438 63233 90136557
Escherichia bacteraemia 12.07 9.74 6 428651 5729 90194061
Hospice care 12.02 9.74 17 428640 9687 90190103
Myocardial ischaemia 11.99 9.74 30 428627 13784 90186006
Skin laceration 11.97 9.74 73 428584 25962 90173828
Gastrointestinal infection 11.95 9.74 21 428636 10969 90188821
Gangrene 11.94 9.74 27 428630 12849 90186941
Sinusitis 11.92 9.74 1823 426834 341265 89858525
Erythema multiforme 11.92 9.74 25 428632 12221 90187569
Shock haemorrhagic 11.92 9.74 25 428632 12220 90187570
Organising pneumonia 11.91 9.74 11 428646 7586 90192204
Hyperammonaemia 11.89 9.74 8 428649 6467 90193323
Lupus nephritis 11.88 9.74 4 428653 4828 90194962
Device use error 11.87 9.74 10 428647 7211 90192579
Tricuspid valve incompetence 11.85 9.74 40 428617 16691 90183099
Allodynia 11.81 9.74 19 428638 1005 90198785
Photophobia 11.76 9.74 153 428504 21116 90178674
Cardiac failure chronic 11.75 9.74 6 428651 5640 90194150
Platelet count abnormal 11.74 9.74 3 428654 4332 90195458
Dysarthria 11.72 9.74 184 428473 54298 90145492
Limb injury 11.71 9.74 94 428563 31414 90168376
Vaginal stricture 11.71 9.74 4 428653 13 90199777
Incorrect route of product administration 11.68 9.74 318 428339 50308 90149482
Deafness 11.63 9.74 160 428497 22354 90177436
Hyperpyrexia 11.61 9.74 4 428653 4757 90195033
Pseudomonal sepsis 11.61 9.74 3 428654 4299 90195491
Migraine without aura 11.57 9.74 16 428641 739 90199051
Intestinal ischaemia 11.57 9.74 15 428642 8868 90190922
Food aversion 11.54 9.74 22 428635 1333 90198457
Tooth disorder 11.53 9.74 209 428448 30881 90168909
Skin papilloma 11.52 9.74 55 428602 5575 90194215
Activated partial thromboplastin time prolonged 11.50 9.74 12 428645 7813 90191977
Nerve degeneration 11.48 9.74 6 428651 67 90199723
Haemoglobin abnormal 11.47 9.74 10 428647 7090 90192700
Hypertonia 11.46 9.74 5 428652 5150 90194640
Schizoaffective disorder 11.43 9.74 5 428652 5142 90194648
Skin mass 11.37 9.74 11 428646 7419 90192371
Osteonecrosis 11.34 9.74 75 428582 26166 90173624
Necrotising ulcerative gingivostomatitis 11.33 9.74 5 428652 37 90199753
Metabolic acidosis 11.33 9.74 190 428467 55486 90144304
Ventricular extrasystoles 11.32 9.74 29 428628 13221 90186569
Atrial flutter 11.30 9.74 21 428636 10737 90189053
Injection site swelling 11.28 9.74 207 428450 59632 90140158
Dyslipidaemia 11.27 9.74 19 428638 10088 90189702
Galactorrhoea 11.26 9.74 4 428653 4668 90195122
Prothrombin time prolonged 11.25 9.74 18 428639 9754 90190036
Pneumonia fungal 11.24 9.74 10 428647 7021 90192769
Immune reconstitution inflammatory syndrome 11.20 9.74 10 428647 7009 90192781
Mental impairment 11.15 9.74 41 428616 16679 90183111
Blood culture positive 11.15 9.74 5 428652 5067 90194723
Gallbladder cholesterolosis 11.04 9.74 16 428641 772 90199018
Renal disorder 11.04 9.74 120 428537 37739 90162051
Illness 11.03 9.74 299 428358 81670 90118120
Dysphonia 11.01 9.74 383 428274 62701 90137089
Wrong product procured 11.01 9.74 3 428654 3 90199787
Colostomy infection 11.01 9.74 3 428654 3 90199787
Toxic encephalopathy 11.01 9.74 15 428642 8684 90191106
Maternal exposure during breast feeding 11.00 9.74 8 428649 6212 90193578
Sensory loss 10.98 9.74 46 428611 18029 90181761
Neutropenic colitis 10.97 9.74 3 428654 4140 90195650
Skin neoplasm excision 10.95 9.74 25 428632 1721 90198069
Therapy change 10.89 9.74 14 428643 8308 90191482
Osteopenia 10.84 9.74 64 428593 22938 90176852
Concomitant disease aggravated 10.81 9.74 24 428633 11494 90188296
Abdominal abscess 10.80 9.74 6 428651 5381 90194409
Anal fissure 10.80 9.74 6 428651 5379 90194411
Emotional distress 10.77 9.74 238 428419 36424 90163366
Eosinophilic pneumonia acute 10.73 9.74 15 428642 700 90199090
Postoperative adhesion 10.71 9.74 12 428645 446 90199344
Arteriosclerosis 10.69 9.74 22 428635 10831 90188959
Incorrect product administration duration 10.68 9.74 139 428518 19183 90180607
Akathisia 10.68 9.74 23 428634 11136 90188654
Panniculitis 10.67 9.74 110 428547 14348 90185442
Azotaemia 10.66 9.74 6 428651 5342 90194448
Nerve compression 10.66 9.74 86 428571 10480 90189310
Increased appetite 10.64 9.74 25 428632 11740 90188050
Influenza like illness 10.60 9.74 295 428362 80316 90119474
Incorrect dose administered 10.60 9.74 288 428369 78642 90121148
Visual field defect 10.52 9.74 11 428646 7155 90192635
Rash morbilliform 10.51 9.74 3 428654 4026 90195764
Granulocytopenia 10.49 9.74 9 428648 6432 90193358
Bone lesion 10.48 9.74 59 428598 6378 90193412
Blood iron abnormal 10.48 9.74 3 428654 4017 90195773
Motor dysfunction 10.45 9.74 51 428606 19179 90180611
Mouth haemorrhage 10.42 9.74 15 428642 8486 90191304
Metabolic disorder 10.37 9.74 12 428645 7458 90192332
Haemarthrosis 10.37 9.74 3 428654 3991 90195799
Lipidosis 10.31 9.74 5 428652 47 90199743
Discomfort 10.28 9.74 1464 427193 272871 89926919
Haemophagocytic lymphohistiocytosis 10.25 9.74 38 428619 15421 90184369
Carotid artery thrombosis 10.23 9.74 17 428640 9075 90190715
Trismus 10.22 9.74 5 428652 4816 90194974
Tongue disorder 10.21 9.74 87 428570 10773 90189017
Sarcoidosis 10.21 9.74 22 428635 10651 90189139
Lung neoplasm malignant 10.18 9.74 70 428587 24203 90175587
Oral disorder 10.17 9.74 21 428636 10324 90189466
Tooth hypoplasia 10.12 9.74 6 428651 87 90199703
Device related sepsis 10.11 9.74 5 428652 4788 90195002
Catheter site pain 10.10 9.74 7 428650 5572 90194218
Psychomotor retardation 10.10 9.74 5 428652 4784 90195006
Renal cancer 10.06 9.74 8 428649 5937 90193853
Pulmonary arterial pressure increased 10.06 9.74 3 428654 3913 90195877
Osteochondrosis 10.06 9.74 25 428632 1818 90197972
Klebsiella infection 10.04 9.74 21 428636 10276 90189514
Therapy partial responder 10.04 9.74 62 428595 21981 90177809
Overlap syndrome 9.98 9.74 72 428585 8476 90191314
Polymenorrhagia 9.96 9.74 5 428652 51 90199739
Meningitis streptococcal 9.95 9.74 7 428650 138 90199652
Gastric cancer 9.90 9.74 6 428651 5130 90194660
Ovarian fibroma 9.88 9.74 6 428651 91 90199699
Pancreatitis 9.85 9.74 253 428404 69573 90130217
Neoplasm skin 9.84 9.74 35 428622 3107 90196683
Renal cyst 9.84 9.74 30 428627 12920 90186870
Cardiomegaly 9.82 9.74 51 428606 18874 90180916
Adenomatous polyposis coli 9.82 9.74 7 428650 141 90199649
General physical condition abnormal 9.81 9.74 6 428651 5105 90194685
Thinking abnormal 9.78 9.74 26 428631 11706 90188084
Blood pressure inadequately controlled 9.77 9.74 9 428648 6215 90193575
Loss of personal independence in daily activities 9.77 9.74 759 427898 135346 90064444
Oesophageal ulcer 9.76 9.74 49 428608 5070 90194720
Pneumothorax 9.76 9.74 52 428605 19115 90180675
Product administration error 9.74 9.74 79 428578 26344 90173446

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
Ankylosing spondylitis 461.72 10.98 255 98676 6801 42515603
Arthralgia 303.11 10.98 1105 97826 204133 42318271
Psoriatic arthropathy 253.15 10.98 301 98630 24666 42497738
Gastric haemorrhage 243.15 10.98 199 98732 10316 42512088
Musculoskeletal stiffness 224.61 10.98 446 98485 57319 42465085
Joint swelling 224.51 10.98 491 98440 67531 42454873
Duodenal ulcer 216.38 10.98 199 98732 12080 42510324
Pain 201.52 10.98 1108 97823 243740 42278664
Psoriasis 170.85 10.98 360 98571 48244 42474160
Lip swelling 153.77 10.98 205 98726 18848 42503556
Neutropenia 153.63 10.98 142 98789 199289 42323115
Upper gastrointestinal haemorrhage 150.46 10.98 260 98671 30039 42492365
Cardiospasm 147.38 10.98 77 98854 1830 42520574
Palmoplantar keratoderma 129.96 10.98 75 98856 2179 42520225
Sleep terror 126.60 10.98 81 98850 2845 42519559
Febrile neutropenia 124.17 10.98 149 98782 185554 42336850
Pruritus genital 124.06 10.98 77 98854 2562 42519842
Gastrointestinal haemorrhage 119.25 10.98 496 98435 97230 42425174
Transient ischaemic attack 117.49 10.98 249 98682 33490 42488914
Tension headache 115.24 10.98 81 98850 3333 42519071
Angioedema 115.23 10.98 284 98647 42193 42480211
Off label use 113.60 10.98 944 97987 637391 41885013
Carotid artery occlusion 111.13 10.98 86 98845 4108 42518296
Facial pain 107.78 10.98 85 98846 4175 42518229
Acne cystic 107.16 10.98 43 98888 539 42521865
Gastric ulcer 104.44 10.98 167 98764 18095 42504309
Thrombocytopenia 103.17 10.98 177 98754 190102 42332302
Congenital hiatus hernia 100.95 10.98 96 98835 6078 42516326
Death 99.28 10.98 664 98267 470521 42051883
Atrial tachycardia 99.18 10.98 80 98851 4060 42518344
Back pain 99.06 10.98 615 98316 141161 42381243
Malignant melanoma in situ 98.90 10.98 68 98863 2699 42519705
Immunisation 97.80 10.98 51 98880 1207 42521197
Melaena 95.66 10.98 250 98681 38496 42483908
Rheumatoid arthritis 93.91 10.98 263 98668 42177 42480227
Anosmia 93.35 10.98 85 98846 5091 42517313
Pancytopenia 86.89 10.98 87 98844 117656 42404748
Pain of skin 86.16 10.98 100 98831 7980 42514424
Abdominal discomfort 84.85 10.98 373 98558 74882 42447522
Migraine 83.25 10.98 183 98748 25231 42497173
Eye pruritus 80.37 10.98 115 98816 11297 42511107
Sepsis 78.69 10.98 221 98710 199113 42323291
Neck pain 78.57 10.98 198 98733 29816 42492588
Hyperhidrosis 78.49 10.98 416 98515 90096 42432308
Peripheral swelling 78.36 10.98 415 98516 89855 42432549
Joint injury 76.88 10.98 129 98802 14547 42507857
Septic shock 74.45 10.98 62 98869 91610 42430794
Arthritis 73.59 10.98 240 98691 41825 42480579
Cardiac failure 73.22 10.98 84 98847 106772 42415632
Nephrolithiasis 71.65 10.98 218 98713 36612 42485792
Duodenal ulcer haemorrhage 70.67 10.98 77 98854 5731 42516673
Synovitis 68.81 10.98 127 98804 15440 42506964
Completed suicide 68.29 10.98 420 98511 96045 42426359
Sacroiliitis 66.84 10.98 47 98884 1935 42520469
Pain in extremity 66.59 10.98 586 98345 150018 42372386
Leukopenia 65.20 10.98 47 98884 74699 42447705
Milk-alkali syndrome 64.70 10.98 32 98899 675 42521729
Gastric ulcer haemorrhage 63.94 10.98 75 98856 6052 42516352
Pericarditis 63.65 10.98 113 98818 13331 42509073
Cytokine release syndrome 63.44 10.98 13 98918 44514 42477890
Nightmare 63.38 10.98 163 98768 24849 42497555
Musculoskeletal discomfort 63.11 10.98 93 98838 9383 42513021
IgM nephropathy 62.03 10.98 20 98911 125 42522279
Disease progression 61.42 10.98 153 98778 143503 42378901
Duodenal ulcer perforation 59.62 10.98 42 98889 1734 42520670
Breath sounds abnormal 59.00 10.98 103 98828 11990 42510414
Myelosuppression 57.26 10.98 12 98919 40449 42481955
General physical health deterioration 55.09 10.98 174 98757 151072 42371332
Nasopharyngitis 54.66 10.98 358 98573 83638 42438766
Muscle twitching 54.47 10.98 98 98833 11682 42510722
Faeces discoloured 54.01 10.98 121 98810 16893 42505511
Cytomegalovirus infection 53.86 10.98 6 98925 32300 42490104
Gastrooesophageal reflux disease 53.67 10.98 227 98704 44796 42477608
Arthropathy 52.78 10.98 170 98761 29427 42492977
Fibromyalgia 51.35 10.98 54 98877 3859 42518545
Drug resistance 50.91 10.98 9 98922 34239 42488165
Gastroduodenal ulcer 49.97 10.98 27 98904 688 42521716
Insomnia 49.10 10.98 454 98477 117799 42404605
Enthesopathy 48.57 10.98 58 98873 4770 42517634
Bradycardia 46.74 10.98 79 98852 85405 42436999
Undifferentiated connective tissue disease 46.63 10.98 15 98916 93 42522311
Hypokalaemia 46.33 10.98 59 98872 71662 42450742
Seronegative arthritis 45.93 10.98 31 98900 1193 42521211
Withdrawal arrhythmia 45.08 10.98 13 98918 52 42522352
Grip strength decreased 44.41 10.98 48 98883 3540 42518864
Benign prostatic hyperplasia 44.16 10.98 128 98803 20924 42501480
Ascites 43.98 10.98 40 98891 56638 42465766
Abdominal pain upper 43.76 10.98 335 98596 82274 42440130
Hypercholesterolaemia 43.75 10.98 94 98837 12755 42509649
Osteoarthritis 43.35 10.98 140 98791 24265 42498139
Glomerulonephritis membranous 43.24 10.98 32 98899 1428 42520976
Haematemesis 43.02 10.98 161 98770 30038 42492366
Peptic ulcer 42.85 10.98 46 98885 3366 42519038
Rash papular 42.06 10.98 88 98843 11723 42510681
Hyponatraemia 41.85 10.98 110 98821 101352 42421052
C-reactive protein abnormal 41.49 10.98 76 98855 9185 42513219
Drug interaction 41.41 10.98 408 98523 266591 42255813
Discomfort 40.65 10.98 140 98791 25079 42497325
Gastritis 40.41 10.98 135 98796 23812 42498592
Neutrophil count decreased 40.10 10.98 53 98878 63362 42459042
Mechanical ventilation complication 39.46 10.98 23 98908 681 42521723
Anaemia 38.72 10.98 440 98491 279838 42242566
Spinal pain 37.38 10.98 61 98870 6721 42515683
Pancreatic steatosis 37.24 10.98 15 98916 190 42522214
Urticaria 36.33 10.98 295 98636 73741 42448663
Dactylitis 35.84 10.98 26 98905 1125 42521279
Bronchiectasis 35.36 10.98 107 98824 17912 42504492
Feeling abnormal 35.30 10.98 280 98651 69506 42452898
Disability 34.94 10.98 55 98876 5878 42516526
Micturition urgency 34.87 10.98 82 98849 11816 42510588
Cardiogenic shock 34.35 10.98 20 98911 35620 42486784
Atrial fibrillation 34.32 10.98 187 98744 139406 42382998
Musculoskeletal disorder 34.30 10.98 58 98873 6580 42515824
Arteriosclerosis coronary artery 33.95 10.98 108 98823 18569 42503835
Muscle swelling 33.77 10.98 18 98913 446 42521958
Hepatic function abnormal 33.74 10.98 42 98889 51525 42470879
Visual impairment 33.22 10.98 192 98739 42921 42479483
Renal papillary necrosis 33.13 10.98 13 98918 153 42522251
Amnesia 32.82 10.98 142 98789 28295 42494109
Pneumonia 32.68 10.98 739 98192 421410 42100994
Administration site inflammation 32.56 10.98 10 98921 52 42522352
Subarachnoid haemorrhage 32.31 10.98 90 98841 14382 42508022
Peptic ulcer perforation 31.95 10.98 16 98915 347 42522057
Lymphocyte count 31.70 10.98 14 98917 226 42522178
Diverticulitis 31.26 10.98 120 98811 22653 42499751
Diplopia 31.20 10.98 111 98820 20205 42502199
Hospitalisation 31.09 10.98 80 98851 74250 42448154
Accidental exposure to product by child 30.76 10.98 27 98904 1540 42520864
Foetal exposure during pregnancy 30.47 10.98 39 98892 47272 42475132
Product used for unknown indication 30.46 10.98 24 98907 1177 42521227
Gamma-glutamyltransferase increased 30.25 10.98 19 98912 32478 42489926
Tinnitus 30.02 10.98 140 98791 28798 42493606
Joint effusion 29.78 10.98 51 98880 5846 42516558
Mucosal inflammation 29.48 10.98 43 98888 49331 42473073
Confusional state 29.47 10.98 248 98683 167349 42355055
Neuroleptic malignant syndrome 29.11 10.98 7 98924 21465 42500939
Lipoma 28.94 10.98 30 98901 2108 42520296
Ventricular fibrillation 28.89 10.98 17 98914 30106 42492298
Seizure 28.81 10.98 163 98768 120398 42402006
Heart rate increased 28.77 10.98 217 98714 53038 42469366
Gastritis erosive 28.67 10.98 53 98878 6450 42515954
Hypoglycaemia 28.58 10.98 60 98871 59794 42462610
Lymphocyte count abnormal 28.38 10.98 30 98901 2157 42520247
Gastrointestinal ulcer 28.29 10.98 28 98903 1862 42520542
Tendon disorder 28.16 10.98 37 98894 3352 42519052
Pyrexia 27.93 10.98 699 98232 393343 42129061
Epilepsy 27.72 10.98 13 98918 26158 42496246
White blood cell count decreased 27.62 10.98 147 98784 110249 42412155
Headache 27.57 10.98 739 98192 238630 42283774
Polyneuropathy 27.53 10.98 5 98926 18656 42503748
Electrocardiogram QT prolonged 27.42 10.98 43 98888 47902 42474502
Chronic pigmented purpura 27.12 10.98 11 98920 142 42522262
Anaphylactic reaction 27.07 10.98 181 98750 42562 42479842
Renal impairment 26.90 10.98 148 98783 110080 42412324
Gastritis bacterial 26.52 10.98 14 98917 340 42522064
Bone marrow failure 26.09 10.98 23 98908 33070 42489334
Dizziness 26.04 10.98 760 98171 248494 42273910
Drug tolerance 25.92 10.98 35 98896 3255 42519149
Wheezing 25.65 10.98 216 98715 54565 42467839
Spinal osteoarthritis 25.60 10.98 60 98871 8626 42513778
Multiple organ dysfunction syndrome 25.52 10.98 127 98804 96908 42425496
Diverticular perforation 25.51 10.98 37 98894 3679 42518725
Anxiety 25.24 10.98 401 98530 118159 42404245
Extrapyramidal disorder 25.09 10.98 4 98927 16408 42505996
Sedation 24.98 10.98 138 98793 30337 42492067
Joint stiffness 24.96 10.98 74 98857 12248 42510156
Blindness 24.90 10.98 95 98836 17883 42504521
Gastrointestinal fistula 24.73 10.98 16 98915 573 42521831
Pseudoporphyria 24.72 10.98 15 98916 479 42521925
Drug hypersensitivity 24.60 10.98 345 98586 99044 42423360
Eye swelling 24.54 10.98 72 98859 11848 42510556
Back disorder 24.48 10.98 54 98877 7460 42514944
Hypophosphataemia 24.44 10.98 9 98922 20936 42501468
Platelet count decreased 24.38 10.98 205 98726 138376 42384028
Secondary amyloidosis 24.32 10.98 10 98921 134 42522270
Pulmonary embolism 24.31 10.98 170 98761 119442 42402962
Bacteraemia 24.20 10.98 14 98917 25026 42497378
Iritis 24.12 10.98 25 98906 1757 42520647
Exposure to communicable disease 24.07 10.98 11 98920 193 42522211
Intervertebral disc degeneration 24.06 10.98 53 98878 7314 42515090
Hypocalcaemia 23.75 10.98 21 98910 30152 42492252
Disturbance in attention 23.66 10.98 134 98797 29732 42492672
Loss of personal independence in daily activities 23.63 10.98 197 98734 49619 42472785
Tendonitis 23.55 10.98 63 98868 9831 42512573
Musculoskeletal pain 23.46 10.98 145 98786 33195 42489209
Mycobacterium tuberculosis complex test positive 23.45 10.98 23 98908 1513 42520891
Anti-glomerular basement membrane disease 23.34 10.98 8 98923 62 42522342
Bronchopulmonary aspergillosis 23.27 10.98 8 98923 19421 42502983
Nail bed bleeding 23.15 10.98 14 98917 444 42521960
Nausea 23.15 10.98 1134 97797 395665 42126739
Asthma 22.77 10.98 233 98698 62081 42460323
Chest pain 22.62 10.98 452 98479 139078 42383326
Blood pressure systolic increased 22.49 10.98 126 98805 27842 42494562
Lymphopenia 22.39 10.98 11 98920 21552 42500852
Neck injury 22.34 10.98 21 98910 1310 42521094
Drug ineffective for unapproved indication 22.27 10.98 46 98885 46117 42476287
Energy increased 22.20 10.98 22 98909 1465 42520939
Appendicitis 22.20 10.98 10 98921 20603 42501801
Adverse reaction 22.12 10.98 36 98895 3957 42518447
Therapeutic product effect incomplete 22.12 10.98 257 98674 70682 42451722
Dyspnoea exertional 22.04 10.98 195 98736 49953 42472451
Hiatus hernia 21.90 10.98 56 98875 8504 42513900
Acute biphenotypic leukaemia 21.82 10.98 8 98923 77 42522327
Renal failure 21.67 10.98 221 98710 143505 42378899
Malaise 21.36 10.98 644 98287 211512 42310892
Acute respiratory distress syndrome 21.34 10.98 23 98908 30085 42492319
Status epilepticus 21.27 10.98 5 98926 15573 42506831
Deep vein thrombosis 21.23 10.98 99 98832 76858 42445546
Inflammation 21.23 10.98 143 98788 33704 42488700
Fatigue 21.20 10.98 1224 97707 434417 42087987
Penile swelling 21.15 10.98 18 98913 985 42521419
Lymphocyte count decreased 21.13 10.98 20 98911 27789 42494615
Emphysema 21.11 10.98 68 98863 11767 42510637
Cutaneous vasculitis 20.89 10.98 48 98883 6812 42515592
Pneumonia aspiration 20.86 10.98 54 98877 50024 42472380
Respiratory failure 20.58 10.98 194 98737 127938 42394466
Vasculitis 20.57 10.98 91 98840 18303 42504101
Gangrene neonatal 20.48 10.98 10 98921 205 42522199
Respiratory tract malformation 20.27 10.98 4 98927 0 42522404
Hyperphosphataemia 20.26 10.98 3 98928 13001 42509403
Exostosis 20.10 10.98 42 98889 5589 42516815
Palpitations 20.04 10.98 193 98738 50604 42471800
Bone hypertrophy 19.99 10.98 11 98920 291 42522113
Posterior reversible encephalopathy syndrome 19.88 10.98 3 98928 12818 42509586
Alopecia 19.77 10.98 126 98805 29150 42493254
Failure of child resistant product closure 19.73 10.98 6 98925 30 42522374
Hyperglycaemia 19.45 10.98 49 98882 45810 42476594
Product use in unapproved indication 19.44 10.98 306 98625 184150 42338254
Sinusitis 19.31 10.98 181 98750 47111 42475293
Pneumocystis jirovecii pneumonia 19.26 10.98 18 98913 25163 42497241
Venous angioma of brain 19.25 10.98 6 98925 33 42522371
Dry skin 19.24 10.98 184 98747 48154 42474250
Dysstasia 19.15 10.98 74 98857 14012 42508392
Uveitis 19.13 10.98 56 98875 9202 42513202
Agranulocytosis 18.93 10.98 26 98905 30586 42491818
Neoplasm progression 18.57 10.98 24 98907 28976 42493428
Hepatic cytolysis 18.48 10.98 21 98910 26823 42495581
Hepatitis B core antibody positive 18.42 10.98 11 98920 341 42522063
Swollen joint count decreased 18.33 10.98 10 98921 260 42522144
Tender joint count decreased 18.33 10.98 10 98921 260 42522144
Coronary artery disease 18.28 10.98 198 98733 53522 42468882
Enterococcal infection 18.25 10.98 3 98928 12036 42510368
Therapy partial responder 18.23 10.98 12 98919 20009 42502395
Gastric ulcer perforation 18.20 10.98 17 98914 1052 42521352
Hepatotoxicity 18.08 10.98 19 98912 25148 42497256
Mobility decreased 18.03 10.98 142 98789 35164 42487240
Tongue disorder 17.89 10.98 39 98892 5344 42517060
Malignant neoplasm progression 17.89 10.98 163 98768 108237 42414167
Encephalopathy 17.65 10.98 44 98887 41289 42481115
Steatorrhoea 17.57 10.98 15 98916 824 42521580
Blood bilirubin unconjugated 17.51 10.98 4 98927 4 42522400
Meniscus injury 17.48 10.98 25 98906 2454 42519950
Intentional product misuse 17.44 10.98 220 98711 61680 42460724
Influenza like illness 17.34 10.98 130 98801 31710 42490694
Tendon pain 17.27 10.98 29 98902 3271 42519133
Arrhythmia 17.16 10.98 43 98888 40274 42482130
Gait disturbance 17.07 10.98 321 98610 97679 42424725
Nervous system neoplasm 17.03 10.98 8 98923 150 42522254
Obstructive pancreatitis 16.85 10.98 14 98917 741 42521663
Chronic obstructive pulmonary disease 16.81 10.98 222 98709 62892 42459512
Tuberculin test positive 16.80 10.98 17 98914 1161 42521243
Infection parasitic 16.70 10.98 11 98920 406 42521998
Cytopenia 16.60 10.98 10 98921 17487 42504917
Aspergillus infection 16.57 10.98 8 98923 15829 42506575
Spondyloarthropathy 16.46 10.98 15 98916 899 42521505
Oral pustule 16.46 10.98 9 98922 235 42522169
Overdose 16.39 10.98 339 98592 104925 42417479
End stage renal disease 16.37 10.98 9 98922 16549 42505855
Inappropriate antidiuretic hormone secretion 16.34 10.98 9 98922 16532 42505872
Blood lactate dehydrogenase increased 16.28 10.98 22 98909 26059 42496345
Clumsiness 16.18 10.98 21 98910 1879 42520525
Weight decrease neonatal 16.16 10.98 10 98921 331 42522073
Productive cough 16.15 10.98 187 98744 51380 42471024
Hypotension 16.12 10.98 465 98466 257166 42265238
Psychotic disorder 15.95 10.98 27 98904 29181 42493223
Hepatic failure 15.93 10.98 41 98890 38059 42484345
Coma 15.91 10.98 67 98864 53487 42468917
Tracheal atresia 15.90 10.98 4 98927 8 42522396
COVID-19 pneumonia 15.89 10.98 16 98915 21597 42500807
Hypogammaglobulinaemia 15.88 10.98 4 98927 11887 42510517
Toxic skin eruption 15.85 10.98 6 98925 13724 42508680
Local reaction 15.79 10.98 7 98924 114 42522290
Skin turgor decreased 15.69 10.98 12 98919 563 42521841
Hallucination 15.61 10.98 203 98728 57304 42465100
Ulcer haemorrhage 15.59 10.98 27 98904 3123 42519281
Tooth disorder 15.53 10.98 62 98869 11917 42510487
Intentional overdose 15.41 10.98 185 98746 51271 42471133
Drug dependence 15.40 10.98 118 98813 28976 42493428
Blood creatine phosphokinase increased 15.29 10.98 59 98872 48279 42474125
Pericardial calcification 15.28 10.98 5 98926 33 42522371
Blood phosphorus increased 15.27 10.98 5 98926 12520 42509884
Pseudomonas infection 15.25 10.98 9 98922 15914 42506490
Enterorrhaphy 15.20 10.98 3 98928 0 42522404
Rash maculo-papular 15.19 10.98 41 98890 37462 42484942
Progressive multifocal leukoencephalopathy 15.18 10.98 4 98927 11532 42510872
Orthostatic hypotension 15.14 10.98 30 98901 30540 42491864
Aplastic anaemia 15.00 10.98 5 98926 12379 42510025
Sensitivity to weather change 14.99 10.98 21 98910 2022 42520382
Fracture 14.86 10.98 47 98884 8056 42514348
Fixed eruption 14.80 10.98 23 98908 2431 42519973
Lymph nodes scan abnormal 14.79 10.98 5 98926 37 42522367
Ankle fracture 14.77 10.98 34 98897 4832 42517572
Hypoxia 14.76 10.98 98 98833 69688 42452716
Acute myeloid leukaemia 14.69 10.98 18 98913 22238 42500166
Venoocclusive liver disease 14.69 10.98 3 98928 10299 42512105
Ischaemic stroke 14.65 10.98 18 98913 22215 42500189
Post-traumatic stress disorder 14.60 10.98 22 98909 2263 42520141
Sleep apnoea syndrome 14.59 10.98 93 98838 21515 42500889
Metabolic alkalosis 14.54 10.98 21 98910 2080 42520324
Hidradenitis 14.45 10.98 19 98912 1722 42520682
Ejection fraction decreased 14.43 10.98 18 98913 22069 42500335
Throat tightness 14.36 10.98 52 98879 9547 42512857
Dysarthria 14.33 10.98 46 98885 39761 42482643
Joint range of motion decreased 14.24 10.98 45 98886 7708 42514696
Restlessness 14.23 10.98 29 98902 29220 42493184
Delirium 14.23 10.98 68 98863 52451 42469953
Troponin increased 14.14 10.98 14 98917 19048 42503356
Dystonia 14.10 10.98 6 98925 12784 42509620
SAPHO syndrome 14.06 10.98 10 98921 419 42521985
Transaminases increased 14.05 10.98 35 98896 32850 42489554
Skin irritation 13.95 10.98 44 98887 7530 42514874
Rheumatoid nodule 13.95 10.98 25 98906 2970 42519434
Duodenitis 13.86 10.98 36 98895 5520 42516884
Ligament calcification 13.84 10.98 8 98923 233 42522171
Glomerulonephritis minimal lesion 13.83 10.98 12 98919 674 42521730
Poisoning 13.72 10.98 69 98862 14630 42507774
Peptic ulcer haemorrhage 13.66 10.98 12 98919 685 42521719
Tumour lysis syndrome 13.62 10.98 19 98912 22212 42500192
Swelling face 13.62 10.98 110 98821 27444 42494960
Angiopathy 13.57 10.98 35 98896 5342 42517062
Decreased activity 13.56 10.98 34 98897 5101 42517303
Scab 13.56 10.98 37 98894 5841 42516563
Inflammatory pain 13.54 10.98 11 98920 564 42521840
Scrotal inflammation 13.50 10.98 4 98927 18 42522386
Application site haematoma 13.47 10.98 5 98926 50 42522354
Congenital umbilical hernia 13.32 10.98 9 98922 347 42522057
Sopor 13.31 10.98 7 98924 13195 42509209
Schizophrenia 13.24 10.98 4 98927 10546 42511858
Pathogen resistance 13.23 10.98 5 98926 11445 42510959
Aspartate aminotransferase increased 13.18 10.98 115 98816 77048 42445356
Diverticulum 13.16 10.98 43 98888 7498 42514906
Disease recurrence 13.14 10.98 31 98900 29647 42492757
Incorrect dosage administered 13.12 10.98 18 98913 1700 42520704
Memory impairment 13.10 10.98 176 98755 50046 42472358
Drug withdrawal maintenance therapy 13.08 10.98 7 98924 175 42522229
Kounis syndrome 13.06 10.98 26 98905 3342 42519062
Depressed level of consciousness 13.06 10.98 62 98869 47908 42474496
Myasthenia gravis 12.98 10.98 11 98920 16126 42506278
Stress ulcer 12.89 10.98 8 98923 266 42522138
Intestinal ischaemia 12.84 10.98 3 98928 9385 42513019
Respiratory arrest 12.73 10.98 111 98820 28313 42494091
Moaning 12.63 10.98 13 98918 906 42521498
Nasal congestion 12.59 10.98 114 98817 29387 42493017
Respiratory symptom 12.58 10.98 5 98926 11101 42511303
Pruritus 12.58 10.98 547 98384 188224 42334180
Rhabdomyolysis 12.57 10.98 118 98813 77901 42444503
Cholestasis 12.54 10.98 37 98894 32842 42489562
Hyperthyroidism 12.52 10.98 9 98922 14332 42508072
Hypomagnesaemia 12.42 10.98 30 98901 28458 42493946
Purpura fulminans 12.39 10.98 7 98924 195 42522209
Swollen tongue 12.31 10.98 88 98843 21143 42501261
Renal cortical necrosis 12.30 10.98 7 98924 198 42522206
Salivary hypersecretion 12.28 10.98 5 98926 10938 42511466
Hepatic enzyme abnormal 12.21 10.98 26 98905 3506 42518898
Neck mass 12.09 10.98 18 98913 1832 42520572
Renal arteriosclerosis 12.08 10.98 8 98923 298 42522106
Muscular weakness 12.06 10.98 266 98665 83232 42439172
Osteonecrosis of jaw 11.96 10.98 16 98915 19033 42503371
Face oedema 11.95 10.98 63 98868 13603 42508801
Acute respiratory failure 11.93 10.98 48 98883 38810 42483594
Fibromuscular dysplasia 11.92 10.98 3 98928 6 42522398
Diabetes mellitus 11.90 10.98 86 98845 60001 42462403
Neurotoxicity 11.89 10.98 23 98908 23628 42498776
Rotator cuff syndrome 11.89 10.98 38 98893 6548 42515856
Hallucination, visual 11.88 10.98 19 98912 21001 42501403
Lumbar radiculopathy 11.82 10.98 12 98919 823 42521581
Condition aggravated 11.81 10.98 490 98441 260264 42262140
Red blood cell sedimentation rate increased 11.79 10.98 50 98881 9874 42512530
Back injury 11.70 10.98 29 98902 4319 42518085
Bacterial infection 11.66 10.98 30 98901 27849 42494555
Pre-existing condition improved 11.65 10.98 23 98908 2940 42519464
Product label issue 11.62 10.98 8 98923 318 42522086
Inspiratory capacity decreased 11.62 10.98 23 98908 2944 42519460
Nail injury 11.56 10.98 4 98927 32 42522372
Palatal oedema 11.47 10.98 13 98918 1011 42521393
Tandem gait test abnormal 11.45 10.98 4 98927 33 42522371
Clostridium difficile infection 11.43 10.98 22 98909 22637 42499767
Loss of proprioception 11.39 10.98 9 98922 443 42521961
Second primary malignancy 11.37 10.98 4 98927 9571 42512833
Akathisia 11.36 10.98 5 98926 10446 42511958
Syndesmophyte 11.36 10.98 7 98924 230 42522174
Chronic idiopathic pain syndrome 11.35 10.98 6 98925 146 42522258
Hypersensitivity vasculitis 11.35 10.98 24 98907 3220 42519184
Alcoholic hangover 11.33 10.98 3 98928 8 42522396
Thrombosis 11.31 10.98 103 98828 68408 42453996
Clostridium difficile colitis 11.28 10.98 20 98911 21232 42501172
Acute generalised exanthematous pustulosis 11.27 10.98 3 98928 8592 42513812
Obstructive airways disorder 11.25 10.98 97 98834 24662 42497742
Urosepsis 11.18 10.98 11 98920 15009 42507395
Anal fissure 11.12 10.98 32 98899 5207 42517197
Laryngospasm 11.12 10.98 18 98913 1970 42520434
Arthroscopy 11.07 10.98 6 98925 154 42522250
Alcohol use 11.06 10.98 22 98909 2826 42519578
Device leakage 11.06 10.98 5 98926 10280 42512124
Synovial cyst 11.06 10.98 21 98910 2608 42519796
Myoclonus 11.05 10.98 14 98917 17051 42505353
Full blood count abnormal 11.05 10.98 112 98819 29764 42492640
Rash pruritic 11.04 10.98 123 98808 33480 42488924
Bladder cancer 11.03 10.98 14 98917 17033 42505371
Miosis 11.02 10.98 9 98922 13437 42508967
Brain oedema 10.99 10.98 13 98918 16314 42506090

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
Psoriatic arthropathy 868.37 10.30 2237 446528 194524 109946010
Synovitis 681.99 10.30 2552 446213 271540 109868994
Neutropenia 663.60 10.30 346 448419 374274 109766260
C-reactive protein abnormal 621.64 10.30 1522 447243 128173 110012361
Fibromyalgia 613.54 10.30 1802 446963 169107 109971427
Death 599.15 10.30 1209 447556 697660 109442874
Febrile neutropenia 569.22 10.30 287 448478 316480 109824054
Ankylosing spondylitis 547.49 10.30 476 448289 15136 110125398
Anaemia 515.76 10.30 893 447872 546193 109594341
Musculoskeletal stiffness 500.79 10.30 2356 446409 277466 109863068
Migraine 471.37 10.30 1651 447114 170001 109970533
Joint swelling 462.63 10.30 3229 445536 439616 109700918
Arthropathy 445.64 10.30 2324 446441 285198 109855336
Pancytopenia 440.85 10.30 150 448615 209463 109931071
Joint range of motion decreased 433.69 10.30 1281 447484 120551 110019983
Drug interaction 428.45 10.30 865 447900 499318 109641216
Thrombocytopenia 416.47 10.30 481 448284 348404 109792130
Sepsis 413.12 10.30 431 448334 326915 109813619
Injury 411.39 10.30 1615 447150 175650 109964884
Facet joint syndrome 406.46 10.30 1081 447684 95747 110044787
Type 2 diabetes mellitus 395.46 10.30 1595 447170 175637 109964897
Mobility decreased 388.00 10.30 1948 446817 235474 109905060
Inflammation 385.12 10.30 1680 447085 191558 109948976
Disease progression 364.80 10.30 274 448491 243760 109896774
Wound infection 358.39 10.30 1030 447735 95435 110045099
Impaired healing 356.64 10.30 1663 447102 195054 109945480
Lip dry 355.86 10.30 1052 447713 99031 110041503
Arthralgia 355.59 10.30 4771 443994 774861 109365673
Cardiac failure 353.75 10.30 159 448606 187467 109953067
Rheumatic fever 345.96 10.30 1190 447575 121389 110019145
Bursitis 339.80 10.30 1230 447535 128688 110011846
Blepharospasm 338.75 10.30 712 448053 54139 110086395
Obesity 321.27 10.30 1102 447663 112249 110028285
Drug intolerance 317.26 10.30 2771 445994 403741 109736793
Breast cancer stage III 314.70 10.30 866 447899 78251 110062283
Hyponatraemia 314.37 10.30 253 448512 217400 109923134
Duodenal ulcer perforation 310.96 10.30 1487 447278 176213 109964321
Hypoaesthesia 298.27 10.30 2240 446525 311983 109828551
Hand deformity 294.60 10.30 1701 447064 216805 109923729
Folliculitis 294.12 10.30 1404 447361 166249 109974285
Glossodynia 292.67 10.30 1718 447047 220286 109920248
Peripheral venous disease 291.27 10.30 876 447889 83241 110057293
Red blood cell sedimentation rate abnormal 288.93 10.30 423 448342 24086 110116448
Helicobacter infection 287.73 10.30 1479 447286 180398 109960136
Abdominal pain upper 287.71 10.30 2409 446356 346702 109793832
Musculoskeletal pain 287.24 10.30 1485 447280 181538 109958996
Pain 286.91 10.30 5451 443314 949504 109191030
Grip strength decreased 286.21 10.30 844 447921 79330 110061204
Gait inability 285.76 10.30 1204 447561 135172 110005362
Pericarditis 278.17 10.30 1679 447086 217435 109923099
Liver injury 275.82 10.30 1276 447489 149137 109991397
Neck pain 275.27 10.30 1109 447656 122021 110018513
Irritable bowel syndrome 274.98 10.30 1357 447408 162858 109977676
Rheumatoid arthritis 271.01 10.30 2112 446653 297501 109843033
Pemphigus 267.82 10.30 1637 447128 212933 109927601
Onychomadesis 267.29 10.30 580 448185 45083 110095451
Platelet count decreased 267.06 10.30 325 448440 230118 109910416
C-reactive protein increased 266.62 10.30 1654 447111 216265 109924269
Night sweats 263.15 10.30 1160 447605 132823 110007711
Urticaria 260.44 10.30 2196 446569 316661 109823873
Hypotension 258.14 10.30 1170 447595 522679 109617855
Memory impairment 255.64 10.30 1518 447247 195426 109945108
Bradycardia 253.14 10.30 159 448606 155358 109985176
Myelosuppression 252.61 10.30 40 448725 94300 110046234
Drug hypersensitivity 252.26 10.30 2885 445880 451205 109689329
Peripheral swelling 250.65 10.30 2624 446141 401410 109739124
Contraindicated product administered 244.14 10.30 1785 446980 246482 109894052
Swelling 242.87 10.30 2332 446433 348709 109791825
Blood cholesterol increased 241.58 10.30 1427 447338 183358 109957176
Abdominal discomfort 240.58 10.30 2550 446215 391308 109749226
Systemic lupus erythematosus 237.83 10.30 1807 446958 252531 109888003
Acute kidney injury 237.26 10.30 1557 447208 633873 109506661
Leukopenia 234.19 10.30 158 448607 148633 109991901
Muscle injury 232.47 10.30 1159 447606 139648 110000886
Osteoarthritis 230.23 10.30 1397 447368 181226 109959308
Gastrooesophageal reflux disease 225.77 10.30 1375 447390 178601 109961933
Anti-cyclic citrullinated peptide antibody positive 225.55 10.30 1386 447379 180598 109959936
Taste disorder 224.53 10.30 679 448086 64708 110075826
Back injury 223.50 10.30 553 448212 46846 110093688
Nail disorder 217.46 10.30 621 448144 57314 110083220
Hypercholesterolaemia 216.62 10.30 835 447930 90002 110050532
Malignant neoplasm progression 216.55 10.30 233 448532 174334 109966200
Pain in extremity 213.73 10.30 2962 445803 484156 109656378
Cytokine release syndrome 209.59 10.30 21 448744 70285 110070249
Dry mouth 208.95 10.30 1459 447306 198489 109942045
Off label use 208.94 10.30 4573 444192 1495612 108644922
Pyrexia 207.28 10.30 2491 446274 895774 109244760
Renal impairment 205.67 10.30 278 448487 188167 109952367
Therapeutic product effect decreased 199.59 10.30 1683 447082 242633 109897901
Wheezing 197.93 10.30 1738 447027 253492 109887042
Cardiospasm 195.80 10.30 162 448603 4805 110135729
Atrial fibrillation 195.60 10.30 398 448367 229244 109911290
Dislocation of vertebra 194.55 10.30 499 448266 43222 110097312
Drug abuse 193.33 10.30 262 448503 177149 109963385
Multiple organ dysfunction syndrome 193.22 10.30 198 448567 151512 109989022
Wound 191.00 10.30 1614 447151 232823 109907711
Swollen joint count increased 189.74 10.30 757 448008 82904 110057630
Neutrophil count decreased 188.22 10.30 130 448635 120811 110019723
Respiratory failure 187.85 10.30 368 448397 214964 109925570
White blood cell count decreased 187.45 10.30 407 448358 228983 109911551
Lower respiratory tract infection 186.21 10.30 1651 447114 241455 109899079
Renal failure 184.32 10.30 403 448362 226171 109914363
Psoriasis 183.51 10.30 1082 447683 138911 110001623
Drug resistance 181.44 10.30 12 448753 56362 110084172
Sleep disorder 178.78 10.30 1399 447366 197245 109943289
Palmoplantar keratoderma 178.38 10.30 159 448606 5228 110135306
Cytomegalovirus infection 174.02 10.30 12 448753 54432 110086102
Lip swelling 173.82 10.30 526 448239 50141 110090393
Ill-defined disorder 173.63 10.30 1161 447604 155692 109984842
Pruritus genital 168.97 10.30 168 448597 6354 110134180
Onychomycosis 168.59 10.30 437 448328 38094 110102440
Drug tolerance 164.17 10.30 264 448501 16321 110124213
Constipation 163.85 10.30 820 447945 356966 109783568
Sleep terror 163.42 10.30 166 448599 6444 110134090
Blister 162.34 10.30 1521 447244 225855 109914679
Polyarthritis 161.24 10.30 282 448483 18681 110121853
Ascites 159.31 10.30 89 448676 92719 110047815
Angioedema 157.78 10.30 804 447961 97696 110042838
Tension headache 157.75 10.30 195 448570 9423 110131111
Finger deformity 154.87 10.30 385 448380 32707 110107827
Hypoglycaemia 154.21 10.30 146 448619 115958 110024576
Joint destruction 151.48 10.30 204 448561 10739 110129795
Hepatic function abnormal 148.48 10.30 89 448676 89206 110051328
Seizure 148.44 10.30 434 448331 220751 109919783
Arthritis 147.88 10.30 1175 447590 166411 109974123
Rheumatoid factor positive 144.85 10.30 973 447792 130667 110009867
Lung disorder 144.72 10.30 1236 447529 178811 109961723
Neuropathy peripheral 142.42 10.30 323 448442 178954 109961580
Deep vein thrombosis postoperative 141.32 10.30 545 448220 58746 110081788
Pneumonia 138.35 10.30 2616 446149 874098 109266436
Intentional product use issue 136.95 10.30 1574 447191 246332 109894202
Gastric haemorrhage 135.74 10.30 237 448528 15678 110124856
Sciatica 135.48 10.30 736 448029 91663 110048871
Alopecia 134.43 10.30 2153 446612 362600 109777934
Nasopharyngitis 134.37 10.30 2298 446467 392063 109748471
Duodenal ulcer 134.32 10.30 265 448500 19249 110121285
Immunisation 134.28 10.30 108 448657 3075 110137459
Rheumatoid nodule 132.98 10.30 270 448495 20026 110120508
Dyspepsia 132.59 10.30 1270 447495 189695 109950839
Carotid artery occlusion 131.93 10.30 178 448587 9387 110131147
Dehydration 130 10.30 637 448128 278874 109861660
Cardiac failure congestive 130.00 10.30 260 448505 150740 109989794
Paraesthesia 129.95 10.30 1703 447062 274818 109865716
Gastric ulcer 127.82 10.30 404 448361 39423 110101111
Amnesia 127.52 10.30 798 447967 104610 110035924
Cardiac arrest 127.03 10.30 393 448372 196360 109944174
Mucosal inflammation 126.39 10.30 122 448643 96019 110044515
Product quality issue 125.93 10.30 634 448131 76665 110063869
Prescribed overdose 125.30 10.30 693 448072 86888 110053646
Gamma-glutamyltransferase increased 125.19 10.30 46 448719 61263 110079271
Orthostatic hypotension 125.04 10.30 56 448709 66193 110074341
Hypoxia 124.87 10.30 208 448557 129307 110011227
Bone marrow failure 122.24 10.30 41 448724 57807 110082727
Human antichimeric antibody positive 121.18 10.30 80 448685 1662 110138872
Muscle spasms 120.81 10.30 1689 447076 276468 109864066
Cardiogenic shock 120.54 10.30 41 448724 57297 110083237
Hepatic cytolysis 119.91 10.30 37 448728 55016 110085518
Blood creatinine increased 119.71 10.30 363 448402 182526 109958008
Adjustment disorder with depressed mood 119.38 10.30 421 448344 43462 110097072
Hypomagnesaemia 117.16 10.30 49 448716 60321 110080213
Atrial tachycardia 116.37 10.30 164 448601 9014 110131520
Body height below normal 112.75 10.30 82 448683 2002 110138532
Posterior reversible encephalopathy syndrome 112.64 10.30 6 448759 33855 110106679
Agranulocytosis 112.25 10.30 55 448710 61705 110078829
Encephalopathy 111.11 10.30 99 448666 80956 110059578
Epilepsy 111.02 10.30 742 448023 99467 110041067
Adverse reaction 109.86 10.30 316 448449 29278 110111256
Product label confusion 109.47 10.30 267 448498 22410 110118124
Hyperglycaemia 108.38 10.30 111 448654 84979 110055555
Live birth 108.37 10.30 563 448202 68921 110071613
Lower limb fracture 108.32 10.30 597 448168 74751 110065783
Electrocardiogram QT prolonged 105.96 10.30 174 448591 108786 110031748
Autoimmune disorder 105.90 10.30 536 448229 64947 110075587
Stomatitis 105.15 10.30 1610 447155 268632 109871902
Septic shock 105.01 10.30 310 448455 157218 109983316
Disability 104.82 10.30 315 448450 29908 110110626
Road traffic accident 104.77 10.30 771 447994 106627 110033907
Colitis 104.63 10.30 158 448607 102165 110038369
Discomfort 104.50 10.30 1331 447434 213376 109927158
Thrombotic microangiopathy 104.28 10.30 3 448762 29146 110111388
Syncope 102.80 10.30 447 448318 202089 109938445
Joint laxity 101.40 10.30 83 448682 2424 110138110
Anosmia 100.28 10.30 181 448584 12291 110128243
Foot deformity 98.38 10.30 424 448341 48056 110092478
Drug tolerance decreased 97.37 10.30 289 448476 27251 110113283
Musculoskeletal disorder 96.03 10.30 254 448511 22410 110118124
Cerebral haemorrhage 95.66 10.30 74 448691 64894 110075640
Hypokalaemia 95.46 10.30 398 448367 182050 109958484
Gastrointestinal disorder 94.33 10.30 1442 447323 240510 109900024
Pulmonary fibrosis 94.15 10.30 723 448042 101319 110039215
Neoplasm progression 93.31 10.30 75 448690 64520 110076014
Liver function test increased 92.34 10.30 646 448119 87902 110052632
Aspartate aminotransferase increased 91.92 10.30 336 448429 159600 109980934
Pain of skin 91.60 10.30 231 448534 19798 110120736
Hyperkalaemia 91.41 10.30 266 448499 135530 110005004
Ventricular fibrillation 91.37 10.30 27 448738 41286 110099248
X-ray abnormal 91.35 10.30 351 448414 37766 110102768
Blood creatine phosphokinase increased 91.19 10.30 97 448668 72980 110067554
Facial pain 91.09 10.30 196 448569 15143 110125391
Seronegative arthritis 90.76 10.30 179 448586 12998 110127536
Bacteraemia 89.65 10.30 30 448735 42360 110098174
Infusion related reaction 89.24 10.30 2100 446665 379062 109761472
Depression 88.52 10.30 1793 446972 315542 109824992
Hypersensitivity 88.31 10.30 2205 446560 401793 109738741
Hepatic enzyme increased 88.16 10.30 1809 446956 319083 109821451
Rhabdomyolysis 87.65 10.30 227 448538 120174 110020360
Toxicity to various agents 87.46 10.30 1397 447368 479158 109661376
Acute respiratory failure 87.28 10.30 106 448659 75154 110065380
Arrhythmia 87.21 10.30 92 448673 69483 110071051
Psychotic disorder 87.19 10.30 49 448716 50888 110089646
Loose body in joint 86.35 10.30 60 448705 1360 110139174
Infusion site reaction 86.22 10.30 209 448556 17473 110123061
Dyspnoea 85.09 10.30 3650 445115 1103222 109037312
Somnolence 84.93 10.30 784 447981 296665 109843869
Pulmonary embolism 84.20 10.30 517 448248 213957 109926577
Cerebrovascular accident 83.18 10.30 415 448350 180869 109959665
Muscular weakness 83.14 10.30 1444 447321 247024 109893510
Respiratory distress 83.10 10.30 94 448671 68780 110071754
Sopor 82.45 10.30 23 448742 36523 110104011
Bronchopulmonary aspergillosis 81.45 10.30 12 448753 29851 110110683
Neurotoxicity 80.72 10.30 35 448730 42172 110098362
Acute respiratory distress syndrome 80.37 10.30 59 448706 53139 110087395
Foot operation 80.16 10.30 122 448643 7191 110133343
C-reactive protein 79.10 10.30 287 448478 30044 110110490
Aspergillus infection 78.07 10.30 7 448758 25609 110114925
Depressed level of consciousness 77.72 10.30 217 448548 112061 110028473
Cerebral infarction 77.66 10.30 58 448707 51780 110088754
Joint effusion 77.38 10.30 223 448542 20682 110119852
Pharyngitis 77.27 10.30 251 448514 24847 110115687
Myelodysplastic syndrome 76.74 10.30 28 448737 37456 110103078
Cholestasis 75.74 10.30 90 448675 64428 110076106
Coma 75.66 10.30 236 448529 117633 110022901
Insomnia 75.52 10.30 1957 446808 358633 109781901
Red blood cell sedimentation rate increased 75.16 10.30 560 448205 77742 110062792
Pneumonia aspiration 75.06 10.30 134 448631 81099 110059435
Pneumocystis jirovecii pneumonia 74.76 10.30 40 448725 42695 110097839
Hypothyroidism 74.11 10.30 113 448652 72786 110067748
Acute myeloid leukaemia 73.84 10.30 31 448734 38079 110102455
Deafness transitory 73.15 10.30 49 448716 1044 110139490
Osteonecrosis of jaw 72.87 10.30 53 448712 47964 110092570
Neuroleptic malignant syndrome 72.21 10.30 24 448741 34035 110106499
Hypervolaemia 71.98 10.30 57 448708 49403 110091131
Systemic lupus erythematosus rash 71.25 10.30 62 448703 1973 110138561
Pseudoporphyria 71.20 10.30 43 448722 760 110139774
Eosinophilia 71.07 10.30 78 448687 57858 110082676
Hypophosphataemia 71.02 10.30 23 448742 33159 110107375
Blood pressure decreased 70.69 10.30 235 448530 114856 110025678
Ulcer haemorrhage 70.64 10.30 227 448538 22344 110118190
Gastric ulcer haemorrhage 70.59 10.30 138 448627 9956 110130578
Sleep disorder due to general medical condition, insomnia type 70.55 10.30 697 448068 104946 110035588
Hepatic failure 70.41 10.30 106 448659 68633 110071901
Lymphocyte count decreased 70.29 10.30 77 448688 57166 110083368
Dysphagia 70.25 10.30 352 448413 153248 109987286
Prescribed underdose 70.03 10.30 479 448286 64695 110075839
Weight increased 69.51 10.30 2211 446554 417433 109723101
Joint injury 69.39 10.30 334 448431 39660 110100874
Fall 69.36 10.30 1891 446874 601591 109538943
Treatment failure 69.07 10.30 1541 447224 275693 109864841
Polyneuropathy 68.85 10.30 22 448743 31990 110108544
Dizziness 68.83 10.30 3478 445287 694715 109445819
Alanine aminotransferase increased 68.53 10.30 450 448315 183323 109957211
Wheelchair user 68.47 10.30 118 448647 7724 110132810
Nephrolithiasis 68.42 10.30 482 448283 65730 110074804
Pleural effusion 68.38 10.30 431 448334 177278 109963256
Wrong technique in product usage process 68.03 10.30 159 448606 87189 110053345
Pulmonary oedema 67.86 10.30 197 448568 100462 110040072
Premature delivery 67.78 10.30 20 448745 30612 110109922
Product dose omission issue 67.70 10.30 909 447856 320873 109819661
Blood bilirubin increased 66.94 10.30 129 448636 75843 110064691
Lymphopenia 66.83 10.30 40 448725 40130 110100404
Hepatotoxicity 66.67 10.30 96 448669 63304 110077230
Gastrointestinal pain 66.40 10.30 148 448617 11712 110128822
Intestinal obstruction 66.02 10.30 71 448694 53156 110087378
Lactic acidosis 66.02 10.30 177 448588 92634 110047900
Circulatory collapse 65.84 10.30 47 448718 42946 110097588
Status epilepticus 65.63 10.30 23 448742 31548 110108986
Tenosynovitis stenosans 65.55 10.30 77 448688 3526 110137008
Upper gastrointestinal haemorrhage 65.48 10.30 387 448378 49709 110090825
Hallucination, visual 65.10 10.30 40 448725 39565 110100969
Blood alkaline phosphatase increased 64.66 10.30 118 448647 70817 110069717
Swelling face 64.54 10.30 615 448150 91706 110048828
International normalised ratio increased 64.39 10.30 162 448603 86610 110053924
Drug reaction with eosinophilia and systemic symptoms 64.29 10.30 149 448616 81946 110058588
Cytopenia 64.24 10.30 21 448744 30095 110110439
Shoulder arthroplasty 63.83 10.30 76 448689 3531 110137003
Duodenal ulcer haemorrhage 63.81 10.30 116 448649 7921 110132613
Metastases to liver 63.57 10.30 32 448733 35354 110105180
Device related infection 63.46 10.30 41 448724 39478 110101056
COVID-19 pneumonia 61.77 10.30 37 448728 37106 110103428
Pulmonary hypertension 61.71 10.30 80 448685 55140 110085394
Porphyria acute 61.64 10.30 192 448573 18588 110121946
Electrolyte imbalance 61.42 10.30 37 448728 36991 110103543
Tumour lysis syndrome 61.40 10.30 24 448741 30777 110109757
Rash maculo-papular 61.16 10.30 131 448634 74091 110066443
Injection site reaction 61.11 10.30 591 448174 88479 110052055
Urosepsis 60.98 10.30 24 448741 30651 110109883
Ischaemic stroke 60.75 10.30 47 448718 41216 110099318
Enthesopathy 60.32 10.30 147 448618 12331 110128203
Pseudomonas infection 60.16 10.30 19 448746 27834 110112700
Haematoma 60.06 10.30 90 448675 58386 110082148
Tremor 59.90 10.30 528 448237 201704 109938830
Blood lactate dehydrogenase increased 59.74 10.30 55 448710 44279 110096255
Rash 59.69 10.30 3979 444786 816985 109323549
Transaminases increased 59.08 10.30 104 448661 63286 110077248
Plasma cell myeloma 58.89 10.30 103 448662 62833 110077701
Tenosynovitis 58.64 10.30 172 448593 16111 110124423
Congenital hiatus hernia 58.39 10.30 97 448668 6162 110134372
Chills 58.03 10.30 494 448271 190086 109950448
Palmar-plantar erythrodysaesthesia syndrome 57.56 10.30 49 448716 40976 110099558
Oedema 57.38 10.30 1183 447582 208793 109931741
Clostridium difficile colitis 57.02 10.30 56 448709 43722 110096812
Neovascularisation 56.98 10.30 51 448714 1686 110138848
Schizophrenia 56.76 10.30 10 448755 21816 110118718
Cardio-respiratory arrest 56.74 10.30 259 448506 115577 110024957
Acute pulmonary oedema 56.57 10.30 3 448762 16993 110123541
Cytomegalovirus viraemia 56.52 10.30 4 448761 17760 110122774
Restlessness 56.43 10.30 88 448677 56171 110084363
Enterococcal infection 55.97 10.30 8 448757 20358 110120176
Malignant melanoma in situ 55.20 10.30 70 448695 3472 110137062
Synovial fluid analysis 55.05 10.30 61 448704 2620 110137914
Muscle twitching 54.85 10.30 254 448511 29681 110110853
Hip arthroplasty 54.60 10.30 401 448364 55412 110085122
Subcutaneous drug absorption impaired 53.91 10.30 105 448660 7554 110132980
Therapy non-responder 53.60 10.30 917 447848 156390 109984144
Aplastic anaemia 53.55 10.30 16 448749 24292 110116242
Urinary tract infection 52.99 10.30 968 447797 325314 109815220
Red blood cell sedimentation rate 52.98 10.30 84 448681 5130 110135404
Osteoporosis 52.94 10.30 564 448201 86588 110053946
Pneumonitis 52.90 10.30 148 448617 76383 110064151
Epstein-Barr virus infection 52.35 10.30 7 448758 18731 110121803
Unresponsive to stimuli 52.22 10.30 113 448652 63677 110076857
Diabetes mellitus 51.84 10.30 217 448548 99164 110041370
Chronic kidney disease 51.65 10.30 149 448616 76142 110064392
Nerve injury 51.56 10.30 126 448639 10587 110129947
Drug level increased 51.42 10.30 71 448694 47648 110092886
Malaise 51.28 10.30 3270 445495 668549 109471985
Chronic sinusitis 50.91 10.30 19 448746 25065 110115469
Pathogen resistance 50.83 10.30 6 448759 17666 110122868
Pulmonary arterial hypertension 50.67 10.30 35 448730 32533 110108001
Altered state of consciousness 50.64 10.30 98 448667 57528 110083006
Myoclonus 50.63 10.30 36 448729 32962 110107572
Balance disorder 50.55 10.30 272 448493 116288 110024246
Inappropriate antidiuretic hormone secretion 50.54 10.30 38 448727 33813 110106721
Diabetes mellitus inadequate control 50.45 10.30 29 448736 29746 110110788
IgM nephropathy 50.32 10.30 20 448745 131 110140403
Infection 50.30 10.30 1870 446895 360330 109780204
Hyperthyroidism 50.30 10.30 28 448737 29233 110111301
Malnutrition 50.02 10.30 24 448741 27255 110113279
Myocarditis 49.90 10.30 30 448735 30025 110110509
Generalised tonic-clonic seizure 49.80 10.30 91 448674 54589 110085945
Sinusitis 49.56 10.30 1565 447200 295123 109845411
Toxic skin eruption 49.25 10.30 25 448740 27490 110113044
Aggression 49.20 10.30 104 448661 59106 110081428
Ileus 49.18 10.30 32 448733 30697 110109837
Oxygen saturation decreased 49.11 10.30 404 448361 156578 109983956
Bacterial infection 49.10 10.30 69 448696 45967 110094567
Disseminated intravascular coagulation 49.10 10.30 57 448708 41229 110099305
Left ventricular dysfunction 49.03 10.30 17 448748 23476 110117058
Adverse event 48.93 10.30 665 448100 108144 110032390
Pericardial effusion 48.82 10.30 99 448666 57118 110083416
Creatinine renal clearance decreased 48.71 10.30 14 448751 21801 110118733
Hepatic encephalopathy 48.62 10.30 27 448738 28229 110112305
Hyperphosphataemia 48.54 10.30 5 448760 16376 110124158
Tendonitis 48.30 10.30 222 448543 25861 110114673
Subdural haematoma 48.21 10.30 46 448719 36408 110104126
Clostridium difficile infection 48.15 10.30 86 448679 52043 110088491
Haemoptysis 47.84 10.30 140 448625 71214 110069320
Oedema peripheral 47.61 10.30 994 447771 327666 109812868
End stage renal disease 47.54 10.30 14 448751 21459 110119075
Limb discomfort 47.35 10.30 306 448459 40548 110099986
Right ventricular failure 47.33 10.30 23 448742 25931 110114603
Multiple fractures 47.20 10.30 109 448656 8831 110131703
Device expulsion 47.00 10.30 34 448731 30857 110109677
Venoocclusive liver disease 46.77 10.30 4 448761 15203 110125331
Epistaxis 46.72 10.30 323 448442 130049 110010485
Labelled drug-drug interaction medication error 46.24 10.30 31 448734 29271 110111263
Diabetic ketoacidosis 45.90 10.30 62 448703 41996 110098538
Drug specific antibody 45.84 10.30 57 448708 2771 110137763
Lupus vulgaris 45.74 10.30 264 448501 33619 110106915
Proctitis 45.71 10.30 7 448758 16920 110123614
Progressive multifocal leukoencephalopathy 45.69 10.30 22 448743 24934 110115600
Ankle arthroplasty 45.55 10.30 54 448711 2497 110138037
Bone density decreased 45.45 10.30 156 448609 15886 110124648
Pemphigoid 45.21 10.30 12 448753 19695 110120839
Knee arthroplasty 45.07 10.30 432 448333 64516 110076018
Troponin increased 44.98 10.30 33 448732 29733 110110801
Ejection fraction decreased 44.88 10.30 60 448705 40820 110099714
Impaired work ability 44.66 10.30 219 448546 26200 110114334
Eye pruritus 44.65 10.30 256 448509 32519 110108015
Synovial cyst 44.33 10.30 124 448641 11306 110129228
Staphylococcal infection 44.21 10.30 141 448624 69803 110070731
Musculoskeletal discomfort 44.08 10.30 201 448564 23337 110117197
Haematuria 44.07 10.30 180 448585 82825 110057709
Maternal exposure during pregnancy 44.02 10.30 1350 447415 253533 109887001
Toothache 43.91 10.30 201 448564 23374 110117160
Rash papular 43.82 10.30 225 448540 27414 110113120
Femur fracture 43.79 10.30 320 448445 44149 110096385
Appendicitis 43.74 10.30 31 448734 28433 110112101
Pancreatitis acute 43.58 10.30 114 448651 60160 110080374
Cardiotoxicity 43.33 10.30 8 448757 16873 110123661
Coeliac disease 43.23 10.30 312 448453 42875 110097659
Aphasia 43.11 10.30 111 448654 58886 110081648
Interstitial lung disease 42.94 10.30 360 448405 138974 110001560
Hypocholesterolaemia 42.75 10.30 86 448679 6335 110134199
General symptom 42.53 10.30 104 448661 8742 110131792
Foetal death 42.50 10.30 7 448758 16038 110124496
Sedation complication 42.07 10.30 14 448751 19841 110120693
Tachycardia 41.79 10.30 657 448108 225988 109914546
Prostate cancer 41.58 10.30 55 448710 37586 110102948
Hypoalbuminaemia 41.40 10.30 34 448731 28940 110111594
COVID-19 41.37 10.30 722 448043 244338 109896196
Drug level decreased 41.24 10.30 12 448753 18536 110121998
Dystonia 41.13 10.30 27 448738 25778 110114756
Product use issue 40.82 10.30 1599 447166 310096 109830438
Brain oedema 40.25 10.30 40 448725 31058 110109476
Vascular device infection 39.94 10.30 9 448756 16503 110124031
Antibody test positive 39.93 10.30 56 448709 3064 110137470
Sacroiliitis 39.71 10.30 72 448693 4906 110135628
Walking aid user 39.66 10.30 204 448561 24871 110115663
Drug use disorder 39.63 10.30 12 448753 18062 110122472
Cartilage atrophy 39.57 10.30 18 448747 171 110140363
Dementia 39.56 10.30 42 448723 31631 110108903
Hypogammaglobulinaemia 39.43 10.30 16 448749 20060 110120474
Iritis 39.31 10.30 69 448696 4583 110135951
Shock 39.02 10.30 101 448664 53487 110087047
Hepatocellular injury 38.78 10.30 93 448672 50549 110089985
Metastases to bone 38.74 10.30 42 448723 31330 110109204
Gastric ulcer perforation 38.51 10.30 47 448718 2241 110138293
Contusion 38.45 10.30 1229 447536 232132 109908402
Metastases to lung 38.32 10.30 23 448742 23040 110117494
Mental status changes 37.99 10.30 169 448596 75953 110064581
Withdrawal arrhythmia 37.93 10.30 13 448752 52 110140482
Transient ischaemic attack 37.90 10.30 412 448353 63570 110076964
Functional gastrointestinal disorder 37.89 10.30 79 448686 5970 110134564
Rheumatoid lung 37.89 10.30 65 448700 4239 110136295
Fear of injection 37.89 10.30 100 448665 8811 110131723
Cholecystitis chronic 37.77 10.30 104 448661 9396 110131138
Therapy interrupted 37.75 10.30 92 448673 49730 110090804
Candida infection 37.70 10.30 87 448678 47922 110092612
Urinary retention 37.69 10.30 150 448615 69533 110071001
Disorientation 37.67 10.30 153 448612 70518 110070016
Haematochezia 37.65 10.30 294 448471 115230 110025304
Underdose 37.53 10.30 409 448356 63145 110077389
Pustular psoriasis 37.41 10.30 131 448634 13474 110127060
Jaundice cholestatic 37.33 10.30 7 448758 14601 110125933
Myopathy 37.29 10.30 28 448737 24932 110115602
Back disorder 37.22 10.30 176 448589 20746 110119788
Treatment noncompliance 37.07 10.30 161 448604 72829 110067705
Neutropenic sepsis 37.05 10.30 42 448723 30704 110109830
Blood calcium decreased 36.98 10.30 55 448710 35790 110104744
Sinus bradycardia 36.93 10.30 39 448726 29444 110111090
Fracture delayed union 36.70 10.30 45 448720 2156 110138378
Haemorrhage intracranial 36.65 10.30 38 448727 28931 110111603
Scleritis 36.57 10.30 73 448692 5347 110135187
Escherichia infection 36.51 10.30 26 448739 23790 110116744
Intestinal diaphragm disease 36.35 10.30 23 448742 443 110140091
Atrioventricular block complete 36.31 10.30 18 448747 20064 110120470
Disease recurrence 36.04 10.30 126 448639 60658 110079876
Cardiomyopathy 36.00 10.30 50 448715 33475 110107059
Erythema 35.85 10.30 904 447861 290543 109849991
Enterocolitis 35.78 10.30 16 448749 18933 110121601
Bunion operation 35.63 10.30 30 448735 912 110139622
Hypertensive crisis 35.57 10.30 28 448737 24344 110116190
Cholangitis 35.53 10.30 11 448754 16324 110124210
Cystitis haemorrhagic 35.48 10.30 4 448761 12205 110128329
Cough 35.36 10.30 1522 447243 460119 109680415
Full blood count decreased 35.35 10.30 47 448718 32052 110108482
Haemophagocytic lymphohistiocytosis 34.97 10.30 46 448719 31513 110109021
Gastroduodenal ulcer 34.84 10.30 30 448735 941 110139593
Thrombosis 34.73 10.30 278 448487 108384 110032150
Haematemesis 34.73 10.30 380 448385 58728 110081806
Ear infection 34.45 10.30 398 448367 62334 110078200
Hepatic enzyme 34.20 10.30 69 448696 5094 110135440
Bladder cancer 34.05 10.30 20 448745 20272 110120262
Dysstasia 34.00 10.30 240 448525 32746 110107788
Acute myocardial infarction 33.88 10.30 200 448565 83577 110056957
Short stature 33.86 10.30 31 448734 1056 110139478
Stress cardiomyopathy 33.75 10.30 11 448754 15795 110124739
Pulmonary alveolar haemorrhage 33.61 10.30 20 448745 20130 110120404
Breast cancer stage II 33.56 10.30 208 448557 27167 110113367
Serotonin syndrome 33.49 10.30 125 448640 59028 110081506
Dysarthria 33.40 10.30 202 448563 83919 110056615
Lipase increased 33.37 10.30 17 448748 18655 110121879
Klebsiella infection 33.18 10.30 20 448745 19989 110120545
Acute coronary syndrome 33.17 10.30 27 448738 23085 110117449
Temperature regulation disorder 33.09 10.30 6 448759 12820 110127714
Laryngitis 32.92 10.30 289 448476 42122 110098412
Tachypnoea 32.90 10.30 69 448696 39326 110101208
Exostosis 32.54 10.30 307 448458 45649 110094885
Cardiac failure chronic 32.47 10.30 8 448757 13803 110126731
Neutrophil count increased 32.15 10.30 57 448708 34595 110105939
Head injury 32.15 10.30 80 448685 42937 110097597
Respiratory tract congestion 32.09 10.30 225 448540 30632 110109902
Dialysis 31.99 10.30 20 448745 19599 110120935
Spondyloarthropathy 31.90 10.30 36 448729 1578 110138956
Haemolytic anaemia 31.86 10.30 23 448742 20897 110119637
Rales 31.81 10.30 32 448733 24707 110115827
Peritonitis bacterial 31.77 10.30 3 448762 10530 110130004
Hyperbilirubinaemia 31.70 10.30 47 448718 30624 110109910
Staphylococcal bacteraemia 31.65 10.30 14 448751 16674 110123860
Serum amyloid A protein increased 31.58 10.30 28 448737 914 110139620
Second primary malignancy 31.48 10.30 17 448748 18051 110122483
Macular degeneration 31.47 10.30 25 448740 21634 110118900
Juvenile idiopathic arthritis 31.45 10.30 73 448692 5934 110134600
Swollen tongue 31.40 10.30 379 448386 59983 110080551
Neurological symptom 31.38 10.30 12 448753 15596 110124938
Synovial disorder 31.32 10.30 49 448716 2958 110137576
Bone disorder 31.18 10.30 169 448596 21023 110119511
Splenomegaly 31.14 10.30 32 448733 24466 110116068
Metastases to central nervous system 31.11 10.30 28 448737 22789 110117745
Lymphadenopathy 31.09 10.30 143 448622 63692 110076842
Myasthenia gravis 31.04 10.30 25 448740 21486 110119048
Ulcer 31.01 10.30 289 448476 42827 110097707
Leukocytosis 30.97 10.30 113 448652 53715 110086819
Soft tissue injury 30.85 10.30 42 448723 2234 110138300
Hypernatraemia 30.74 10.30 17 448748 17816 110122718
Dactylitis 30.74 10.30 58 448707 4075 110136459
Clostridium test positive 30.60 10.30 4 448761 10889 110129645
Adverse drug reaction 30.58 10.30 600 448165 104959 110035575
Nephropathy toxic 30.50 10.30 40 448725 27438 110113096
Blood sodium decreased 30.44 10.30 69 448696 38250 110102284
Accidental exposure to product by child 30.42 10.30 50 448715 3148 110137386
Rash vesicular 30.38 10.30 129 448636 14523 110126011
Immune reconstitution inflammatory syndrome 30.17 10.30 14 448751 16212 110124322
Intestinal ischaemia 30.02 10.30 14 448751 16165 110124369
Device occlusion 29.99 10.30 12 448753 15173 110125361
Activated partial thromboplastin time prolonged 29.84 10.30 28 448737 22340 110118194
Tardive dyskinesia 29.80 10.30 9 448756 13570 110126964
Hallucination, auditory 29.74 10.30 38 448727 26359 110114175
Cachexia 29.68 10.30 8 448757 12997 110127537
Device leakage 29.60 10.30 14 448751 16034 110124500
Vaginal discharge 29.55 10.30 18 448747 17890 110122644
Hyperuricaemia 29.50 10.30 11 448754 14520 110126014
Pineal gland cyst 29.45 10.30 16 448749 229 110140305
Liver disorder 29.44 10.30 771 447994 141472 109999062
Medication overuse headache 29.43 10.30 34 448731 1529 110139005
Therapy cessation 29.36 10.30 89 448676 44768 110095766
Parkinsonism 29.33 10.30 28 448737 22159 110118375
Cardiac disorder 29.33 10.30 185 448580 76095 110064439
Blood parathyroid hormone decreased 29.31 10.30 118 448647 12971 110127563
Respiratory symptom 29.21 10.30 12 448753 14933 110125601
Osteoporotic fracture 29.20 10.30 66 448699 5271 110135263
Bradyphrenia 29.17 10.30 6 448759 11722 110128812
Oral candidiasis 29.16 10.30 89 448676 44671 110095863
Faecaloma 29.09 10.30 12 448753 14896 110125638
Dyskinesia 28.94 10.30 109 448656 51337 110089197
Loss of personal independence in daily activities 28.73 10.30 805 447960 149215 109991319
Sudden death 28.66 10.30 34 448731 24361 110116173
Hyperammonaemia 28.55 10.30 10 448755 13722 110126812
Tenderness 28.51 10.30 211 448554 29226 110111308
Behaviour disorder 28.44 10.30 3 448762 9644 110130890
Therapy partial responder 28.43 10.30 68 448697 36993 110103541
Blood potassium decreased 28.32 10.30 118 448647 53996 110086538
Haemolysis 28.31 10.30 14 448751 15625 110124909
Ventricular extrasystoles 28.30 10.30 30 448735 22611 110117923
Residual urine volume increased 28.26 10.30 12 448753 95 110140439
Female genital tract fistula 28.11 10.30 16 448749 16503 110124031
Hypomania 28.08 10.30 4 448761 10206 110130328
Smear cervix abnormal 27.98 10.30 44 448721 2668 110137866
Arthrodesis 27.91 10.30 44 448721 2674 110137860
Wrist deformity 27.86 10.30 48 448717 3141 110137393
Diffuse large B-cell lymphoma 27.63 10.30 15 448750 15883 110124651
Blood phosphorus increased 27.56 10.30 16 448749 16324 110124210
Metabolic acidosis 27.54 10.30 265 448500 99479 110041055
Hypothermia 27.48 10.30 40 448725 26262 110114272
Product prescribing error 27.44 10.30 111 448654 51220 110089314
Blood urea increased 27.43 10.30 122 448643 54835 110085699
Pharyngeal swelling 27.37 10.30 109 448656 11923 110128611
Endocarditis 27.35 10.30 10 448755 13361 110127173
Limb deformity 27.16 10.30 52 448713 3694 110136840
Pneumonia viral 27.15 10.30 6 448759 11151 110129383
Granuloma skin 27.11 10.30 104 448661 11179 110129355
Nervous system disorder 26.96 10.30 55 448710 31666 110108868
Asphyxia 26.85 10.30 12 448753 14203 110126331
Cardiac failure acute 26.78 10.30 35 448730 24043 110116491
Oesophageal spasm 26.71 10.30 51 448714 3615 110136919
Nodule 26.71 10.30 225 448540 32406 110108128
Oliguria 26.52 10.30 22 448743 18635 110121899
Bone density increased 26.46 10.30 26 448739 969 110139565
Lung infiltration 26.18 10.30 37 448728 24591 110115943
Heparin-induced thrombocytopenia 26.13 10.30 7 448758 11417 110129117
Angina pectoris 26.11 10.30 147 448618 62148 110078386
Mechanical ventilation complication 26.01 10.30 23 448742 748 110139786
Blood calcium increased 25.99 10.30 21 448744 18019 110122515
Anti-cyclic citrullinated peptide antibody 25.94 10.30 154 448611 19810 110120724
Renal function test abnormal 25.82 10.30 3 448762 8943 110131591
Quality of life decreased 25.79 10.30 120 448645 14049 110126485
Cyanosis 25.76 10.30 51 448714 29690 110110844
Glomerulonephritis membranous 25.70 10.30 36 448729 1967 110138567
Enteritis 25.53 10.30 24 448741 19132 110121402
Tooth infection 25.50 10.30 166 448599 22050 110118484
Loss of consciousness 25.47 10.30 604 448161 195702 109944832
Generalised oedema 25.45 10.30 54 448711 30650 110109884
Miosis 25.44 10.30 31 448734 21952 110118582
Organising pneumonia 25.40 10.30 13 448752 14230 110126304
Gastroenteritis viral 25.40 10.30 215 448550 31011 110109523
Bone erosion 25.38 10.30 294 448471 46077 110094457
Mucormycosis 25.30 10.30 6 448759 10622 110129912
Jaw clicking 25.29 10.30 11 448754 93 110140441
Deep vein thrombosis 25.27 10.30 407 448358 139480 110001054
Allergy to chemicals 25.15 10.30 47 448718 3278 110137256
Eosinophil count increased 25.12 10.30 29 448736 21029 110119505
Diarrhoea 24.99 10.30 4154 444611 1135351 109005183
Torsade de pointes 24.98 10.30 33 448732 22567 110117967
Antinuclear antibody positive 24.97 10.30 88 448677 9080 110131454
Pulseless electrical activity 24.78 10.30 19 448746 16738 110123796
Blood potassium increased 24.72 10.30 62 448703 33187 110107347
Hepatocellular carcinoma 24.69 10.30 5 448760 9875 110130659
Adrenal insufficiency 24.66 10.30 272 448493 42118 110098416
Bacterial sepsis 24.59 10.30 6 448759 10420 110130114
Device dislocation 24.45 10.30 58 448707 31646 110108888
Tooth disorder 24.43 10.30 204 448561 29305 110111229
Tendon disorder 24.43 10.30 82 448683 8255 110132279
Proteinuria 24.37 10.30 82 448683 39936 110100598
Anal incontinence 24.35 10.30 32 448733 21932 110118602
Gait disturbance 24.34 10.30 1371 447394 276837 109863697
Pneumatosis intestinalis 24.28 10.30 3 448762 8526 110132008
Undifferentiated connective tissue disease 24.18 10.30 14 448751 228 110140306
Hunger 24.01 10.30 70 448695 6534 110134000
Abscess 23.88 10.30 47 448718 27422 110113112
Atrioventricular block 23.87 10.30 20 448745 16857 110123677
Drug withdrawal syndrome 23.85 10.30 77 448688 37977 110102557
Immune-mediated enterocolitis 23.75 10.30 6 448759 10179 110130355
Drug effective for unapproved indication 23.72 10.30 14 448751 14153 110126381
Administration site inflammation 23.68 10.30 10 448755 78 110140456
Pneumonia bacterial 23.65 10.30 44 448721 26217 110114317
Glycosylated haemoglobin increased 23.63 10.30 37 448728 23582 110116952
Aplasia pure red cell 23.62 10.30 5 448760 9573 110130961
Ventricular hypokinesia 23.60 10.30 8 448757 11206 110129328
Accidental overdose 23.57 10.30 119 448646 51715 110088819
Eczema 23.54 10.30 184 448581 72109 110068425
Hypercapnia 23.42 10.30 8 448757 11151 110129383
Ventricular arrhythmia 23.41 10.30 6 448759 10081 110130453
Drug dose omission by device 23.39 10.30 15 448750 14501 110126033
Hospitalisation 23.34 10.30 422 448343 142071 109998463
Haemorrhage 23.29 10.30 299 448466 106393 110034141
Small intestinal obstruction 23.23 10.30 61 448704 32152 110108382
Autoimmune haemolytic anaemia 23.19 10.30 7 448758 10560 110129974
No adverse event 23.10 10.30 190 448575 73649 110066885
Abnormal behaviour 23.09 10.30 81 448684 38958 110101576
Gastrointestinal fistula 23.06 10.30 24 448741 959 110139575
Sensitivity to weather change 22.93 10.30 91 448674 9937 110130597
Substance abuse 22.80 10.30 11 448754 12452 110128082
Sternal fracture 22.78 10.30 45 448720 3271 110137263
Pneumonia fungal 22.76 10.30 16 448749 14738 110125796
Jaundice 22.60 10.30 144 448621 59092 110081442
Hiccups 22.58 10.30 12 448753 12857 110127677
Peripheral arterial occlusive disease 22.56 10.30 5 448760 9275 110131259
Complication associated with device 22.51 10.30 29 448736 20044 110120490
Disability assessment scale score increased 22.47 10.30 52 448713 4218 110136316
Cardiovascular disorder 22.44 10.30 36 448729 22724 110117810
Bradypnoea 22.41 10.30 4 448761 8645 110131889
Tongue disorder 22.39 10.30 116 448649 14182 110126352
Failure of child resistant product closure 22.26 10.30 9 448756 62 110140472
Chest discomfort 22.25 10.30 536 448229 173312 109967222
Rash pruritic 22.19 10.30 538 448227 97531 110043003
Rhinovirus infection 22.19 10.30 10 448755 11779 110128755
Joint stiffness 22.18 10.30 390 448375 66853 110073681
Coagulopathy 22.16 10.30 88 448677 40823 110099711
Cervicogenic headache 22.12 10.30 13 448752 218 110140316
Parosmia 22.10 10.30 13 448752 13167 110127367
Unevaluable event 22.08 10.30 145 448620 59082 110081452
Staphylococcal sepsis 21.96 10.30 23 448742 17431 110123103
Supraventricular tachycardia 21.92 10.30 41 448724 24381 110116153
Swollen joint count 21.71 10.30 81 448684 8593 110131941
Faeces discoloured 21.70 10.30 222 448543 33726 110106808
Nail psoriasis 21.54 10.30 20 448745 694 110139840
Nightmare 21.53 10.30 247 448518 38616 110101918
Metabolic encephalopathy 21.42 10.30 9 448756 11051 110129483
Product monitoring error 21.33 10.30 5 448760 8922 110131612
Respiratory acidosis 21.32 10.30 15 448750 13811 110126723
Gastroenteritis 21.31 10.30 83 448682 38717 110101817
Post-traumatic neck syndrome 21.30 10.30 38 448727 2557 110137977
Akathisia 21.03 10.30 23 448742 17090 110123444
Electrocardiogram abnormal 21.01 10.30 27 448738 18682 110121852
Glomerulonephritis minimal lesion 20.99 10.30 24 448741 1067 110139467
Glaucoma 20.93 10.30 37 448728 22480 110118054
Diplopia 20.90 10.30 261 448504 41633 110098901
Feeling abnormal 20.89 10.30 915 447850 179796 109960738
Large intestine perforation 20.83 10.30 22 448743 16607 110123927
Partial seizures 20.78 10.30 10 448755 11339 110129195
Nasal polyps 20.78 10.30 14 448751 13186 110127348
Dermatitis exfoliative 20.78 10.30 10 448755 11337 110129197
Peptic ulcer perforation 20.74 10.30 21 448744 812 110139722
Deformity 20.72 10.30 89 448676 10071 110130463
Granulocytopenia 20.68 10.30 13 448752 12702 110127832
Hypertriglyceridaemia 20.65 10.30 21 448744 16133 110124401
Fixed eruption 20.61 10.30 50 448715 4182 110136352
Radiculopathy 20.60 10.30 29 448736 19307 110121227
Failure to thrive 20.57 10.30 15 448750 13559 110126975
Foetal exposure during pregnancy 20.50 10.30 3 448762 7502 110133032
Delusion 20.35 10.30 41 448724 23714 110116820
Toxic encephalopathy 20.35 10.30 19 448746 15195 110125339
Hyperpyrexia 20.34 10.30 4 448761 8065 110132469
Drug level below therapeutic 20.31 10.30 11 448754 11662 110128872
Renal cancer 20.28 10.30 14 448751 13020 110127514
Premature labour 20.27 10.30 6 448759 9166 110131368
Eosinophilic granulomatosis with polyangiitis 20.21 10.30 9 448756 10677 110129857
Neuritis 20.12 10.30 3 448762 7396 110133138
Visual impairment 20.09 10.30 700 448065 133728 110006806
Colorectal cancer 20.07 10.30 6 448759 9108 110131426
Feeling jittery 20.06 10.30 115 448650 14607 110125927
Milk-alkali syndrome 19.96 10.30 32 448733 1973 110138561
Ketoacidosis 19.87 10.30 8 448757 10079 110130455
Azotaemia 19.87 10.30 8 448757 10077 110130457
Metastases to lymph nodes 19.84 10.30 19 448746 15013 110125521
Metabolic disorder 19.65 10.30 9 448756 10501 110130033
Device malfunction 19.52 10.30 47 448718 25511 110115023
Hypertonia 19.51 10.30 5 448760 8401 110132133
Polyuria 19.51 10.30 26 448739 17712 110122822
Panniculitis 19.48 10.30 119 448646 15463 110125071
Left ventricular failure 19.43 10.30 11 448754 11378 110129156
Gastrointestinal ulcer 19.34 10.30 49 448716 4211 110136323
Melaena 19.30 10.30 389 448376 68368 110072166
Glomerular filtration rate decreased 19.27 10.30 57 448708 28899 110111635
Rebound effect 19.21 10.30 19 448746 14787 110125747
Catatonia 19.15 10.30 11 448754 11289 110129245
Aortic stenosis 19.06 10.30 15 448750 13044 110127490
Full blood count abnormal 19.04 10.30 141 448624 55911 110084623
Hostility 19.02 10.30 37 448728 2659 110137875
Hemiplegia 18.94 10.30 40 448725 22742 110117792
Escherichia sepsis 18.89 10.30 9 448756 10263 110130271
Brain natriuretic peptide increased 18.87 10.30 11 448754 11198 110129336
Adenoiditis 18.86 10.30 7 448758 37 110140497
Lung neoplasm malignant 18.84 10.30 72 448693 33770 110106764
Plasma cell myeloma recurrent 18.82 10.30 3 448762 7039 110133495
Caesarean section 18.78 10.30 17 448748 13800 110126734
Respiratory tract infection 18.63 10.30 193 448572 71424 110069110
Arteriosclerosis 18.56 10.30 46 448719 24721 110115813
Transfusion 18.55 10.30 48 448717 25424 110115110
Alanine aminotransferase abnormal 18.45 10.30 81 448684 9253 110131281
Renal papillary necrosis 18.44 10.30 15 448750 434 110140100
Crepitations 18.44 10.30 90 448675 10745 110129789
Vertigo 18.39 10.30 245 448520 86625 110053909
Blood pressure measurement 18.26 10.30 16 448749 514 110140020
Incorrect product administration duration 18.21 10.30 144 448621 20354 110120180
Serum sickness-like reaction 18.06 10.30 19 448746 769 110139765
Rhinitis allergic 18.00 10.30 28 448737 17894 110122640
Hyperthermia 17.98 10.30 37 448728 21235 110119299
Retinal haemorrhage 17.97 10.30 8 448757 9493 110131041
Device ineffective 17.94 10.30 11 448754 200 110140334
Pneumothorax 17.81 10.30 78 448687 35207 110105327
Systemic inflammatory response syndrome 17.79 10.30 16 448749 13027 110127507
Embolism 17.79 10.30 24 448741 16265 110124269
Ileus paralytic 17.75 10.30 13 448752 11724 110128810
Immune-mediated hepatitis 17.62 10.30 3 448762 6708 110133826
Congestive cardiomyopathy 17.60 10.30 19 448746 14200 110126334
Visual acuity reduced 17.56 10.30 69 448696 32104 110108430
Gastritis 17.55 10.30 311 448454 53388 110087146
Blindness 17.50 10.30 225 448540 36134 110104400
Subarachnoid haemorrhage 17.47 10.30 191 448574 29511 110111023
Human anti-human antibody test 17.45 10.30 14 448751 397 110140137
Atrial flutter 17.45 10.30 46 448719 24216 110116318
Anti-transglutaminase antibody 17.44 10.30 5 448760 9 110140525
Exercise tolerance decreased 17.44 10.30 14 448751 12053 110128481
Psychomotor retardation 17.40 10.30 5 448760 7787 110132747
Peptic ulcer 17.31 10.30 69 448696 7550 110132984
Retinitis 17.26 10.30 204 448561 32123 110108411
Collagen-vascular disease 17.23 10.30 8 448757 80 110140454
Intestinal perforation 17.22 10.30 37 448728 20907 110119627
Burns second degree 17.20 10.30 5 448760 7728 110132806
Tinnitus 17.16 10.30 343 448422 60197 110080337
Anxiety 17.04 10.30 1624 447141 343454 109797080
Mental impairment 17.00 10.30 42 448723 22597 110117937
Endophthalmitis 16.95 10.30 6 448759 8181 110132353
Atrioventricular block second degree 16.93 10.30 6 448759 8175 110132359
Decubitus ulcer 16.92 10.30 30 448735 18206 110122328
Drug-induced liver injury 16.90 10.30 621 448144 119446 110021088
Gastric cancer 16.90 10.30 12 448753 10996 110129538
Pre-eclampsia 16.82 10.30 7 448758 8643 110131891
Aspirin-exacerbated respiratory disease 16.82 10.30 20 448745 928 110139606
Psychomotor skills impaired 16.77 10.30 4 448761 7054 110133480
Cytomegalovirus test positive 16.69 10.30 4 448761 7032 110133502
Urinary incontinence 16.61 10.30 122 448643 48465 110092069
Blood glucose increased 16.54 10.30 410 448355 132086 110008448
Swollen joint count decreased 16.47 10.30 13 448752 360 110140174
Bronchospasm 16.41 10.30 65 448700 30174 110110360
Pneumonia cytomegaloviral 16.41 10.30 4 448761 6950 110133584
Varicella zoster virus infection 16.38 10.30 3 448762 6365 110134169
Pleuritic pain 16.38 10.30 117 448648 16023 110124511
Axial spondyloarthritis 16.37 10.30 19 448746 859 110139675
Cerebral ischaemia 16.33 10.30 15 448750 12089 110128445
Gallbladder injury 16.31 10.30 23 448742 1265 110139269
Blood culture positive 16.30 10.30 8 448757 8968 110131566
Liver function test abnormal 16.27 10.30 190 448575 68760 110071774
Spinal fusion surgery 16.27 10.30 77 448688 9079 110131455
Lung opacity 16.25 10.30 14 448751 11638 110128896
Neutrophilia 16.20 10.30 11 448754 10318 110130216
Jejunal ulcer 16.11 10.30 11 448754 242 110140292
Hemiparesis 16.10 10.30 108 448657 43795 110096739
Cardiopulmonary failure 16.01 10.30 6 448759 7897 110132637
Metastases to fallopian tube 15.91 10.30 7 448758 61 110140473
Food aversion 15.91 10.30 26 448739 1629 110138905
Hepatic enzyme abnormal 15.84 10.30 80 448685 9683 110130851
Emotional distress 15.84 10.30 263 448502 44584 110095950
Product storage error 15.78 10.30 41 448724 21687 110118847
Brain abscess 15.78 10.30 4 448761 6770 110133764
Hypertension 15.66 10.30 2329 446436 507755 109632779
Migraine without aura 15.63 10.30 16 448749 627 110139907
Serum ferritin increased 15.61 10.30 15 448750 11832 110128702
Hepatic steatosis 15.57 10.30 125 448640 48706 110091828
Embolic stroke 15.56 10.30 8 448757 8735 110131799
Oesophageal pain 15.55 10.30 51 448714 5074 110135460
Retroperitoneal haematoma 15.53 10.30 3 448762 6128 110134406
N-terminal prohormone brain natriuretic peptide increased 15.50 10.30 3 448762 6118 110134416
Renal injury 15.44 10.30 33 448732 18680 110121854
Squamous cell carcinoma of skin 15.34 10.30 29 448736 17174 110123360
Hypoacusis 15.32 10.30 82 448683 35109 110105425
Skin papilloma 15.31 10.30 62 448703 6834 110133700
Polydipsia 15.31 10.30 6 448759 7682 110132852
Hypophagia 15.30 10.30 138 448627 52488 110088046
IIIrd nerve injury 15.29 10.30 4 448761 4 110140530
Blood bilirubin unconjugated 15.29 10.30 4 448761 4 110140530
Rhinitis 15.28 10.30 44 448721 22501 110118033
Gastritis bacterial 15.22 10.30 15 448750 561 110139973
Back pain 15.20 10.30 1724 447041 369272 109771262
Amylase increased 15.19 10.30 17 448748 12502 110128032
Device related sepsis 15.17 10.30 6 448759 7641 110132893
Cataract 15.12 10.30 229 448536 79256 110061278
Thyroiditis 15.08 10.30 4 448761 6569 110133965
Gynaecomastia 15.03 10.30 10 448755 9480 110131054
Blood glucose decreased 15.00 10.30 65 448700 29423 110111111
Clear cell renal cell carcinoma 14.99 10.30 34 448731 2722 110137812
Euglycaemic diabetic ketoacidosis 14.98 10.30 15 448750 11608 110128926
Frostbite 14.90 10.30 11 448754 275 110140259
Agitation 14.89 10.30 347 448418 112704 110027830
Genital blister 14.89 10.30 10 448755 214 110140320
Purpura 14.83 10.30 50 448715 24338 110116196
Epidermal necrosis 14.82 10.30 36 448729 3014 110137520
Hyperlipidaemia 14.80 10.30 85 448680 35763 110104771
Gastric fistula 14.80 10.30 11 448754 278 110140256
Injection site erythema 14.77 10.30 281 448484 93895 110046639
Coronary arterial stent insertion 14.77 10.30 3 448762 5912 110134622
Hepatitis 14.75 10.30 474 448291 89580 110050954
Spinal compression fracture 14.71 10.30 33 448732 18359 110122175
Hypocalcaemia 14.71 10.30 182 448583 65184 110075350
Neoplasm skin 14.70 10.30 37 448728 3167 110137367
Muscle swelling 14.67 10.30 20 448745 1065 110139469
Poisoning deliberate 14.67 10.30 56 448709 26275 110114259
Chronic pigmented purpura 14.63 10.30 11 448754 283 110140251
Gastritis erosive 14.60 10.30 91 448674 11909 110128625
Libido increased 14.57 10.30 32 448733 2507 110138027
Tender joint count decreased 14.53 10.30 11 448754 286 110140248
Amblyopia 14.53 10.30 11 448754 286 110140248
Therapeutic product effect incomplete 14.49 10.30 1075 447690 222730 109917804
Herpes zoster 14.46 10.30 332 448433 108047 110032487
Necrosis 14.39 10.30 15 448750 11391 110129143
Eye injury 14.35 10.30 66 448699 7689 110132845
Pallor 14.35 10.30 153 448612 56314 110084220
Myofascial pain syndrome 14.28 10.30 32 448733 2541 110137993
Vulvovaginal ulceration 14.21 10.30 5 448760 22 110140512
Pancreatitis 14.08 10.30 281 448484 93252 110047282
Myocardial ischaemia 14.08 10.30 58 448707 26626 110113908
Blood albumin decreased 14.03 10.30 61 448704 27591 110112943
Fungal infection 14.01 10.30 135 448630 50671 110089863
Infective pulmonary exacerbation of cystic fibrosis 13.97 10.30 24 448741 14747 110125787
Cardiac murmur 13.97 10.30 52 448713 24576 110115958
Body temperature decreased 13.94 10.30 219 448546 36716 110103818
Osteonecrosis 13.93 10.30 80 448685 33661 110106873
Performance status decreased 13.93 10.30 6 448759 7260 110133274
Cardiac dysfunction 13.88 10.30 4 448761 6219 110134315
Overlap syndrome 13.84 10.30 73 448692 8986 110131548
Device use error 13.83 10.30 10 448755 9079 110131455
Depressed mood 13.80 10.30 169 448596 60640 110079894
Abortion spontaneous 13.78 10.30 82 448683 34200 110106334
Salpingo-oophorectomy bilateral 13.77 10.30 11 448754 310 110140224
Immune-mediated myositis 13.76 10.30 4 448761 6182 110134352
Endocarditis fibroplastica 13.70 10.30 5 448760 25 110140509
Oesophageal candidiasis 13.63 10.30 16 448749 11518 110129016
Limb asymmetry 13.56 10.30 15 448750 643 110139891
Paranoia 13.52 10.30 46 448719 22328 110118206
Photophobia 13.48 10.30 162 448603 25609 110114925
Nail bed bleeding 13.47 10.30 17 448748 839 110139695
General physical condition abnormal 13.43 10.30 7 448758 7583 110132951
Renal disorder 13.42 10.30 132 448633 49347 110091187
Uveitis 13.42 10.30 141 448624 21569 110118965
Electrocardiogram QRS complex prolonged 13.41 10.30 20 448745 13001 110127533
Aspiration 13.37 10.30 71 448694 30462 110110072
Tendon pain 13.35 10.30 56 448709 6270 110134264
Retroperitoneal haemorrhage 13.34 10.30 4 448761 6061 110134473
Pancreatic carcinoma 13.32 10.30 25 448740 14847 110125687
Diabetes insipidus 13.29 10.30 5 448760 6565 110133969
Squamous cell carcinoma 13.29 10.30 35 448730 18428 110122106
Lethargy 13.24 10.30 284 448481 93292 110047242
Acute hepatic failure 13.23 10.30 90 448675 36378 110104156
Leukaemia 13.20 10.30 7 448758 7511 110133023
Acquired cystic kidney disease 13.19 10.30 6 448759 57 110140477
Blood uric acid increased 13.19 10.30 44 448721 21485 110119049
Withdrawal syndrome 13.18 10.30 74 448691 31306 110109228
Device issue 13.15 10.30 84 448681 34451 110106083
Rash morbilliform 13.11 10.30 8 448757 7943 110132591
Inflammatory pain 13.08 10.30 23 448742 1530 110139004
Bundle branch block left 13.08 10.30 20 448745 12868 110127666
Procedural haemorrhage 13.04 10.30 3 448762 5424 110135110
Abdominal abscess 13.04 10.30 10 448755 8809 110131725
Endometriosis 13.03 10.30 43 448722 4291 110136243
Cardiac tamponade 13.03 10.30 16 448749 11291 110129243
Parainfluenzae virus infection 12.99 10.30 6 448759 6968 110133566
Product preparation error 12.96 10.30 15 448750 10864 110129670
Blood pressure systolic abnormal 12.91 10.30 156 448609 24694 110115840
Weight fluctuation 12.84 10.30 142 448623 22003 110118531
Ovarian hyperstimulation syndrome 12.81 10.30 3 448762 5357 110135177
Gestational diabetes 12.80 10.30 7 448758 7382 110133152
Pulmonary haemorrhage 12.77 10.30 30 448735 16426 110124108
Renal mass 12.71 10.30 38 448727 3597 110136937
Neurological decompensation 12.70 10.30 6 448759 6877 110133657
Increased appetite 12.70 10.30 26 448739 14951 110125583
Skin exfoliation 12.70 10.30 265 448500 87386 110053148
Vaginal infection 12.66 10.30 58 448707 6746 110133788
Stenotrophomonas infection 12.64 10.30 4 448761 5854 110134680
Hypovolaemic shock 12.64 10.30 25 448740 14558 110125976
Bone pain 12.61 10.30 187 448578 64946 110075588
Red cell distribution width decreased 12.58 10.30 28 448737 2213 110138321
Salivary hypersecretion 12.55 10.30 33 448732 17388 110123146
Disease complication 12.54 10.30 4 448761 5823 110134711
Lupus-like syndrome 12.54 10.30 234 448531 40558 110099976
Device difficult to use 12.53 10.30 37 448728 18768 110121766
Dyslipidaemia 12.48 10.30 29 448736 15936 110124598
Lacrimation increased 12.45 10.30 74 448691 30876 110109658
Mania 12.40 10.30 43 448722 20753 110119781
Anti-glomerular basement membrane disease 12.38 10.30 8 448757 160 110140374
Immunodeficiency 12.36 10.30 224 448541 38614 110101920
Areflexia 12.34 10.30 6 448759 6763 110133771
Vaginal stricture 12.31 10.30 4 448761 13 110140521
Medical device site cellulitis 12.29 10.30 9 448756 222 110140312
Apathy 12.29 10.30 30 448735 16209 110124325
Biliary dyskinesia 12.22 10.30 29 448736 2392 110138142
Presyncope 12.21 10.30 133 448632 48754 110091780
Gastrointestinal infection 12.14 10.30 24 448741 13981 110126553
Hydronephrosis 12.14 10.30 43 448722 20622 110119912
Lip oedema 12.14 10.30 62 448703 7538 110132996
Hepatitis cholestatic 12.11 10.30 34 448731 17532 110123002
Blood pressure diastolic abnormal 12.11 10.30 159 448606 25656 110114878
Acute biphenotypic leukaemia 12.08 10.30 8 448757 167 110140367
Hepatic adenoma 12.04 10.30 12 448753 455 110140079
Benign prostatic hyperplasia 12.02 10.30 120 448645 18114 110122420
Mixed liver injury 12.01 10.30 19 448746 12060 110128474
Terminal state 12.00 10.30 4 448761 5663 110134871
Total lung capacity decreased 11.95 10.30 7 448758 7107 110133427
Hereditary angioedema 11.95 10.30 7 448758 7107 110133427
Forced expiratory volume decreased 11.93 10.30 22 448743 13154 110127380
Pneumonia klebsiella 11.91 10.30 6 448759 6626 110133908
Intraocular pressure increased 11.90 10.30 16 448749 10860 110129674
Hypoxic-ischaemic encephalopathy 11.89 10.30 11 448754 8836 110131698
Skin neoplasm excision 11.88 10.30 26 448739 2032 110138502
Acidosis 11.87 10.30 49 448716 22482 110118052
Product prescribing issue 11.86 10.30 21 448744 12751 110127783
Lip and/or oral cavity cancer 11.86 10.30 19 448746 1171 110139363
Syndesmophyte 11.83 10.30 6 448759 74 110140460
Antineutrophil cytoplasmic antibody positive 11.82 10.30 3 448762 5073 110135461
Musculoskeletal deformity 11.81 10.30 22 448743 1531 110139003
Headache 11.80 10.30 3874 444891 878503 109262031
Obstructive airways disorder 11.75 10.30 125 448640 46024 110094510
Hyperprolactinaemia 11.73 10.30 6 448759 6569 110133965
Gingival abscess 11.72 10.30 18 448747 1069 110139465
Subdural haemorrhage 11.68 10.30 6 448759 6552 110133982
Therapy change 11.67 10.30 14 448751 9983 110130551
Embolism venous 11.64 10.30 3 448762 5020 110135514
Oesophageal carcinoma 11.58 10.30 18 448747 11506 110129028
Blood pressure diastolic increased 11.55 10.30 122 448643 18685 110121849
Gastric disorder 11.55 10.30 195 448570 33162 110107372
Grip strength 11.55 10.30 70 448695 9071 110131463
Sickle cell anaemia with crisis 11.54 10.30 13 448752 9532 110131002
Renal tubular disorder 11.53 10.30 8 448757 7421 110133113
Product administration error 11.53 10.30 96 448669 37121 110103413
Haemolytic uraemic syndrome 11.50 10.30 3 448762 4982 110135552
Neoplasm 11.45 10.30 17 448748 11070 110129464
Tachyarrhythmia 11.43 10.30 10 448755 8251 110132283
Bronchiolitis 11.42 10.30 4 448761 5489 110135045
Nephrogenic systemic fibrosis 11.39 10.30 4 448761 5479 110135055
Hepatitis C 11.38 10.30 21 448744 12552 110127982
Ovarian fibroma 11.35 10.30 6 448759 81 110140453
SAPHO syndrome 11.30 10.30 13 448752 582 110139952
Type 1 diabetes mellitus 11.29 10.30 12 448753 9035 110131499
Sinus node dysfunction 11.29 10.30 12 448753 9035 110131499
Incorrect dose administered 11.29 10.30 327 448438 103314 110037220
Herpes simplex 11.25 10.30 30 448735 15734 110124800
Dysphonia 11.25 10.30 395 448370 75534 110065000
Mitral valve incompetence 11.24 10.30 84 448681 33245 110107289
Left ventricular hypertrophy 11.22 10.30 23 448742 13221 110127313
Hyperammonaemic encephalopathy 11.22 10.30 4 448761 5430 110135104
Pelvi-ureteric obstruction 11.21 10.30 10 448755 329 110140205
Colon cancer 11.21 10.30 32 448733 16411 110124123
Hip fracture 11.20 10.30 90 448675 35061 110105473
Gingival bleeding 11.18 10.30 42 448723 19797 110120737
Skin necrosis 11.16 10.30 135 448630 21377 110119157
Venous angioma of brain 11.13 10.30 5 448760 46 110140488
Sinus tachycardia 11.13 10.30 121 448644 44372 110096162
Penile swelling 11.12 10.30 15 448750 791 110139743
Product administered at inappropriate site 11.09 10.30 4 448761 5389 110135145
Peritonitis 11.08 10.30 82 448683 32525 110108009
Ataxia 11.08 10.30 74 448691 30034 110110500
Erythema multiforme 11.04 10.30 46 448719 21051 110119483
Secondary amyloidosis 11.01 10.30 10 448755 337 110140197
Incorrect dosage administered 11.01 10.30 38 448727 3880 110136654
Haemodialysis 11 10.30 36 448729 17683 110122851
Congenital bowing of long bones 10.96 10.30 4 448761 20 110140514
Stent placement 10.96 10.30 8 448757 7226 110133308
Lipidosis 10.95 10.30 5 448760 48 110140486
Intra-abdominal haemorrhage 10.92 10.30 4 448761 5338 110135196
Affective disorder 10.88 10.30 18 448747 11223 110129311
Upper respiratory tract infection 10.88 10.30 429 448336 130899 110009635
Radiation associated pain 10.88 10.30 9 448756 267 110140267
Haemoglobin decreased 10.87 10.30 865 447900 247862 109892672
Haemorrhagic stroke 10.81 10.30 25 448740 13764 110126770
Platelet count abnormal 10.81 10.30 6 448759 6276 110134258
Lipoma 10.80 10.30 38 448727 3917 110136617
Dermatitis acneiform 10.80 10.30 22 448743 12673 110127861
Vitamin B12 deficiency 10.79 10.30 15 448750 10040 110130494
Tender joint count 10.78 10.30 20 448745 1387 110139147
Concussion 10.77 10.30 82 448683 11456 110129078
Polymenorrhagia 10.77 10.30 5 448760 50 110140484
Medical device site abscess 10.77 10.30 8 448757 202 110140332
Cell death 10.76 10.30 5 448760 5786 110134748
Bone lesion 10.75 10.30 57 448708 7030 110133504
Faecal calprotectin increased 10.75 10.30 7 448758 6712 110133822
Bradykinesia 10.70 10.30 17 448748 10771 110129763
Acute lymphocytic leukaemia 10.68 10.30 5 448760 5760 110134774
Sputum increased 10.64 10.30 5 448760 5746 110134788
Blood lactic acid increased 10.63 10.30 31 448734 15790 110124744
Steroid diabetes 10.63 10.30 4 448761 5250 110135284
Hydrocephalus 10.62 10.30 16 448749 10359 110130175
Escherichia urinary tract infection 10.62 10.30 32 448733 16130 110124404
Wrong patient received product 10.61 10.30 7 448758 6667 110133867
Drug ineffective 10.61 10.30 6533 442232 1514007 108626527
Joint ankylosis 10.59 10.30 28 448737 2469 110138065
Flushing 10.54 10.30 334 448431 104402 110036132
Retinal detachment 10.53 10.30 18 448747 11082 110129452
Sarcoidosis 10.53 10.30 22 448743 12557 110127977
Chronic obstructive pulmonary disease 10.53 10.30 350 448415 108808 110031726
Micturition disorder 10.52 10.30 3 448762 4695 110135839
Congestive hepatopathy 10.52 10.30 4 448761 5216 110135318
Femoral neck fracture 10.50 10.30 22 448743 12545 110127989
Electroencephalogram abnormal 10.48 10.30 6 448759 6167 110134367
Product used for unknown indication 10.44 10.30 24 448741 1939 110138595
Pericardial calcification 10.43 10.30 5 448760 54 110140480
Vasculitis 10.42 10.30 204 448561 35669 110104865
Allergic respiratory disease 10.41 10.30 7 448758 150 110140384
Urinary hesitation 10.38 10.30 3 448762 4655 110135879
Premature rupture of membranes 10.31 10.30 3 448762 4634 110135900

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G02CC02 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE02 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE57 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA12 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
ATC N02CC51 NERVOUS SYSTEM
ANALGESICS
ANTIMIGRAINE PREPARATIONS
Selective serotonin (5HT1) agonists
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
MeSH PA D000700 Analgesics
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D018712 Analgesics, Non-Narcotic
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35493 antipyretic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:35845 gout suppressant
CHEBI has role CHEBI:49201 anti-ulcer drug
CHEBI has role CHEBI:50629 cyclooxygenase 2 inhibitor
CHEBI has role CHEBI:50630 cyclooxygenase 1 inhibitor
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:73336 vulnerary
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:88188 drug allergen

Related Drugs by ATC class:

G02CC Antiinflammatory products for vaginal administration 3 drugs
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M01AE Propionic acid derivatives 21 drugs
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N02CC Selective serotonin (5HT1) agonists 8 drugs
almotriptaneletriptanfrovatriptanlasmiditannaratriptanrizatriptansumatriptanzolmitriptan

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

DiseaseRelationSNOMED_IDDOID
Sinus headache indication 4969004
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Toothache indication 27355003
Tendinitis indication 34840004 DOID:971
Migraine indication 37796009 DOID:6364
Joint pain indication 57676002
Nasal discharge indication 64531003
Muscle pain indication 68962001
Rheumatoid arthritis indication 69896004 DOID:7148
Bursitis indication 84017003 DOID:2965
Gout indication 90560007 DOID:13189
Headache disorder indication 230461009
Dysmenorrhea indication 266599000
Fever indication 386661006
Osteoarthritis indication 396275006
Juvenile rheumatoid arthritis indication 410795001
Tachyarrhythmia contraindication 6285003
Alcoholism contraindication 7200002
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Gastrointestinal perforation contraindication 51875005
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hemiplegic migraine contraindication 59292006
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Vascular insufficiency of intestine contraindication 82196007
Atrophic gastritis contraindication 84568007 DOID:8929
Epilepsy contraindication 84757009 DOID:1826
Prinzmetal angina contraindication 87343002
Kidney disease contraindication 90708001 DOID:557
Fracture of bone contraindication 125605004
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Angina pectoris contraindication 194828000
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Benign prostatic hyperplasia contraindication 266569009
Edema contraindication 267038008
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Cerebral ischemia contraindication 287731003
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Serotonin syndrome contraindication 371089000
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Peripheral vascular disease contraindication 400047006
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Hypertensive urgency contraindication 443482000
Smokes tobacco daily contraindication 449868002




🐶 Veterinary Drug Use

SpeciesUseRelation
Horses Myositis Indication
Horses Pain and inflammation associated with arthritis Indication
Horses Soft tissue diseases of the musculoskeletal system Indication

🐶 Veterinary products

ProductApplicantIngredients
Equiproxen Granules Zoetis Inc. 1
Equiproxen 10% Solution Zoetis Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
500MG;EQ 85MG BASE TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG;EQ 10MG BASE TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 5.60 CHEMBL CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 5.16 WOMBAT-PK CHEMBL
Aldo-keto reductase family 1 member C2 Enzyme IC50 4.50 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 6.32 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 6.74 CHEMBL
Prostaglandin-H2 D-isomerase Enzyme IC50 4.89 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 5.47 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 4.96 CHEMBL
Hormone-sensitive lipase Enzyme IC50 5.92 CHEMBL
Cyclooxygenase Enzyme IC50 7.22 CHEMBL
Replicase polyprotein 1ab Enzyme IC50 5.46 CHEMBL

External reference:

IDSource
4018847 VUID
N0000147149 NUI
D00118 KEGG_DRUG
26159-34-2 SECONDARY_CAS_RN
4018846 VANDF
4018847 VANDF
C0027396 UMLSCUI
CHEBI:7476 CHEBI
NPS PDB_CHEM_ID
CHEMBL154 ChEMBL_ID
DB00788 DRUGBANK_ID
CHEMBL1200806 ChEMBL_ID
D009288 MESH_DESCRIPTOR_UI
156391 PUBCHEM_CID
5230 IUPHAR_LIGAND_ID
2979 INN_ID
57Y76R9ATQ UNII
142442 RXNORM
2108 MMSL
2111 MMSL
27852 MMSL
5155 MMSL
5156 MMSL
6350 MMSL
8137 MMSL
d00019 MMSL
002380 NDDF
002381 NDDF
11847009 SNOMEDCT_US
372588000 SNOMEDCT_US
42692007 SNOMEDCT_US
57Y76R9ATQ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0054-3630 SUSPENSION 125 mg ORAL ANDA 28 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-0901 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1412 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-4368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Aleve Headache Pain HUMAN OTC DRUG LABEL 1 0280-0041 TABLET 220 mg ORAL NDA 17 sections
Aleve liquid gels HUMAN OTC DRUG LABEL 1 0280-0105 CAPSULE, LIQUID FILLED 220 mg ORAL ANDA 17 sections
AleveBack and Muscle Pain HUMAN OTC DRUG LABEL 1 0280-0111 TABLET 220 mg ORAL NDA 17 sections
AleveHeadache Pain HUMAN OTC DRUG LABEL 1 0280-0112 TABLET 220 mg ORAL NDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-0113 TABLET 220 mg ORAL NDA 17 sections
AleveCaplets HUMAN OTC DRUG LABEL 1 0280-0114 TABLET 220 mg ORAL NDA 17 sections
AleveCaplets Soft Grip Arthritis HUMAN OTC DRUG LABEL 1 0280-0115 TABLET 220 mg ORAL NDA 17 sections
AleveCaplets Easy Open Arthritis HUMAN OTC DRUG LABEL 1 0280-0130 TABLET 220 mg ORAL NDA 17 sections
AleveEasy Open Arthritis HUMAN OTC DRUG LABEL 1 0280-0131 TABLET 220 mg ORAL NDA 17 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 17 sections
AleveCaplets HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 10 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 10 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 16 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections
AleveCaplets - Easy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6050 TABLET 220 mg ORAL NDA 16 sections
AleveEasy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6060 TABLET 220 mg ORAL NDA 17 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6070 TABLET, COATED 220 mg ORAL NDA 9 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6080 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
Aleve-D Sinus and Cold HUMAN OTC DRUG LABEL 2 0280-6090 TABLET 220 mg ORAL ANDA 17 sections
AleveEasy Open Arthritis Cap HUMAN OTC DRUG LABEL 1 0280-6091 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
Aleve Back and Muscle Pain HUMAN OTC DRUG LABEL 1 0280-6092 TABLET 220 mg ORAL NDA 10 sections
AleveHeadache Pain HUMAN OTC DRUG LABEL 1 0280-8252 TABLET 220 mg ORAL NDA 17 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0102 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
Naproxen Sodium HUMAN OTC DRUG LABEL 1 0363-0177 CAPSULE, LIQUID FILLED 220 mg ORAL NDA 17 sections
All Day Pain Relief HUMAN OTC DRUG LABEL 1 0363-0368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections