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

Stem definitionDrug idCAS RN
anti-inflammatory agents, ibufenac derivatives 865 15307-86-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • diclofenac calcium
  • diclofenac diethylamine
  • diclofenac hydroxyethylpyrrolidine
  • diclofenac
  • diclofenamic acid
  • diclofenac sodium
  • diclofenac potassium
  • diclofenac epolamine
A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
  • Molecular weight: 296.15
  • Formula: C14H11Cl2NO2
  • CLOGP: 4.58
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 49.33
  • ALOGS: -4.82
  • ROTB: 4
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.10 g O
0.10 g P
0.10 g R
0.10 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 10.85 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
S (Water solubility) 0.14 mg/mL Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 54 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.50 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 28, 1988 FDA
March 23, 2021 PMDA Hisamitsu Pharmaceutical Co., Inc

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pemphigus 2158.97 10.04 3144 261399 154068 55873456
Glossodynia 2039.78 10.04 3012 261531 149446 55878078
Systemic lupus erythematosus 1921.06 10.04 3206 261337 176872 55850652
Hand deformity 1763.74 10.04 2633 261910 131859 55895665
Wound 1592.51 10.04 2555 261988 136249 55891275
Pericarditis 1551.59 10.04 2218 262325 106705 55920819
Abdominal discomfort 1480.69 10.04 3705 260838 273569 55753955
Discomfort 1476.06 10.04 2498 262045 139263 55888261
Arthropathy 1373.60 10.04 2954 261589 197321 55830203
Anti-cyclic citrullinated peptide antibody positive 1370.64 10.04 1985 262558 96615 55930909
Alopecia 1129.54 10.04 3481 261062 289977 55737547
Rheumatoid arthritis 1040.66 10.04 4043 260500 378561 55648963
Swelling 1032.96 10.04 2961 261582 236810 55790714
Synovitis 1023.20 10.04 2307 262236 158998 55868526
Duodenal ulcer perforation 1014.20 10.04 1420 263123 66922 55960602
Contraindicated product administered 976.44 10.04 2474 262069 183812 55843712
Helicobacter infection 937.00 10.04 1419 263124 71849 55955675
Maternal exposure during pregnancy 886.77 10.04 2413 262130 187140 55840384
Infusion related reaction 800.27 10.04 2476 262067 206455 55821069
Hepatic enzyme increased 799.68 10.04 2180 262363 169204 55858320
Product use issue 754.74 10.04 2250 262293 183791 55843733
Rheumatoid factor positive 684.72 10.04 1192 263351 67868 55959656
Embolia cutis medicamentosa 664.33 10.04 180 264363 175 56027349
Hypersensitivity 617.53 10.04 2612 261931 253796 55773728
Death 606.97 10.04 433 264110 340993 55686531
Drug intolerance 565.10 10.04 2602 261941 262216 55765308
Joint swelling 552.30 10.04 2756 261787 287044 55740480
Treatment failure 543.02 10.04 1898 262645 168494 55859030
Pain 485.43 10.04 4997 259546 658187 55369337
Blister 450.49 10.04 1327 263216 107560 55919964
Muscle injury 412.20 10.04 820 263723 51680 55975844
Folliculitis 403.48 10.04 835 263708 54144 55973380
Rheumatic fever 384.85 10.04 570 263973 28257 55999267
Irritable bowel syndrome 363.79 10.04 915 263628 67543 55959981
Sleep disorder due to general medical condition, insomnia type 359.73 10.04 693 263850 42645 55984879
Therapeutic product effect decreased 359.33 10.04 1663 262880 167789 55859735
Swollen joint count increased 351.71 10.04 498 264045 23686 56003838
Rash 344.43 10.04 3683 260860 489364 55538160
Musculoskeletal stiffness 297.36 10.04 1485 263058 154522 55873002
Diarrhoea 296.59 10.04 1775 262768 636732 55390792
Hip arthroplasty 292.07 10.04 594 263949 38029 55989495
Neutropenia 289.28 10.04 194 264349 157973 55869551
Completed suicide 280.57 10.04 139 264404 133694 55893830
Febrile neutropenia 279.66 10.04 75 264468 105470 55922054
Toxicity to various agents 272.00 10.04 396 264147 224168 55803356
Impaired healing 258.81 10.04 947 263596 85894 55941630
Pneumonia 256.31 10.04 1015 263528 406083 55621441
Liver injury 240.99 10.04 577 263966 41271 55986253
Gastrointestinal disorder 234.21 10.04 1100 263443 111602 55915922
Knee arthroplasty 233.41 10.04 590 263953 43669 55983855
Type 2 diabetes mellitus 229.95 10.04 608 263935 46254 55981270
Psoriatic arthropathy 228.95 10.04 817 263726 73191 55954333
Deafness transitory 219.18 10.04 128 264415 1814 56025710
Blood cholesterol increased 211.64 10.04 786 263757 71793 55955731
Nausea 208.38 10.04 2446 262097 761732 55265792
Hypotension 204.89 10.04 556 263987 249952 55777572
Cough 204.46 10.04 588 263955 259373 55768151
Product dose omission issue 188.85 10.04 427 264116 204326 55823198
Fall 171.68 10.04 982 263561 356528 55670996
Thrombocytopenia 169.98 10.04 235 264308 135989 55891535
Cardiac failure congestive 165.19 10.04 104 264439 87616 55939908
Constipation 160 10.04 455 264088 201488 55826036
General physical health deterioration 156.63 10.04 1348 263195 168662 55858862
Seizure 152.96 10.04 219 264324 124900 55902624
Dehydration 136.23 10.04 344 264199 158481 55869043
Electrocardiogram QT prolonged 135.05 10.04 44 264499 54544 55972980
Ankylosing spondylitis 133.43 10.04 197 264346 9733 56017791
Urinary tract infection 132.52 10.04 630 263913 239883 55787641
Ill-defined disorder 129.36 10.04 651 263892 67892 55959632
Stomatitis 127.44 10.04 988 263555 119822 55907702
Lower respiratory tract infection 125.11 10.04 946 263597 113848 55913676
Atrial fibrillation 124.98 10.04 199 264344 108698 55918826
Hypokalaemia 123.82 10.04 157 264386 94280 55933244
Pancytopenia 123.20 10.04 141 264402 88574 55938950
Plasma cell myeloma 121.91 10.04 34 264509 46612 55980912
Anxiety 118.48 10.04 486 264057 192686 55834838
Gastric ulcer perforation 118.08 10.04 72 264471 1109 56026415
Infection 116.78 10.04 1446 263097 198760 55828764
White blood cell count decreased 116.68 10.04 262 264281 125728 55901796
Sleep disorder 114.83 10.04 624 263919 67039 55960485
Disease progression 111.67 10.04 202 264341 104971 55922553
Ear infection 111.22 10.04 362 264181 30933 55996591
Asthenia 110.27 10.04 1055 263488 341918 55685606
Sepsis 109.29 10.04 317 264226 139523 55888001
Device expulsion 109.23 10.04 9 264534 30440 55997084
Anaemia 106.73 10.04 777 263766 266734 55760790
Cerebrovascular accident 105.99 10.04 190 264353 99080 55928444
Arthralgia 104.56 10.04 3090 261453 498579 55528945
Platelet count decreased 103.67 10.04 215 264328 106168 55921356
Gastrointestinal pain 103.64 10.04 164 264379 8613 56018911
Leukopenia 99.31 10.04 112 264431 70828 55956696
Pharyngitis 98.61 10.04 248 264295 18290 56009234
Neuropathy peripheral 98.54 10.04 210 264333 102683 55924841
Grip strength decreased 97.74 10.04 228 264315 16028 56011496
Intentional product use issue 96.10 10.04 799 263744 98934 55928590
Gastric ulcer 96.04 10.04 278 264265 22285 56005239
Cardiac arrest 95.97 10.04 161 264382 86153 55941371
Melaena 95.86 10.04 322 264221 27968 55999556
Balance disorder 85.75 10.04 142 264401 76378 55951146
Hospitalisation 85.15 10.04 138 264405 74862 55952662
Neutrophil count decreased 84.62 10.04 66 264477 49756 55977768
Off label use 83.85 10.04 1983 262560 554197 55473327
Contusion 82.47 10.04 945 263598 127485 55900039
Pulmonary arterial hypertension 82.20 10.04 13 264530 26490 56001034
Live birth 79.10 10.04 237 264306 19368 56008156
Hypoxia 78.86 10.04 82 264461 53815 55973709
Dyspnoea 77.53 10.04 2157 262386 590420 55437104
Cognitive disorder 77.40 10.04 70 264473 49063 55978461
Oxygen saturation decreased 76.85 10.04 160 264383 78907 55948617
Shoulder arthroplasty 76.75 10.04 91 264452 3622 56023902
Pleural effusion 76.50 10.04 181 264362 85299 55942225
Cardio-respiratory arrest 75.63 10.04 89 264454 55232 55972292
Injection site pain 75.35 10.04 289 264254 116829 55910695
Fatigue 75.00 10.04 4470 260073 784082 55243442
Heart rate increased 73.99 10.04 177 264366 83096 55944428
Cardiac failure 73.33 10.04 174 264369 81919 55945605
Malignant neoplasm progression 71.44 10.04 149 264394 73438 55954086
Depression 71.36 10.04 524 264019 179593 55847931
Pulmonary embolism 70.43 10.04 262 264281 106862 55920662
Hypoglycaemia 69.86 10.04 96 264447 55719 55971805
Fibromyalgia 68.76 10.04 498 264045 59105 55968419
Bradycardia 68.68 10.04 133 264410 67371 55960153
Red blood cell sedimentation rate abnormal 68.44 10.04 5 264538 18668 56008856
Epistaxis 68.24 10.04 132 264411 66891 55960633
Coma 67.49 10.04 110 264433 59545 55967979
Tachycardia 66.99 10.04 263 264280 105613 55921911
Insomnia 65.51 10.04 581 263962 191279 55836245
Respiratory failure 65.47 10.04 228 264315 94834 55932690
Wrong technique in product usage process 65.12 10.04 108 264435 58060 55969464
Osteoarthritis 64.82 10.04 619 263924 79677 55947847
Mental status changes 63.28 10.04 50 264493 37451 55990073
COVID-19 63.20 10.04 164 264379 74894 55952630
Myocardial infarction 63.12 10.04 224 264319 92646 55934878
Pulmonary oedema 61.98 10.04 90 264453 51053 55976471
Multiple sclerosis relapse 61.64 10.04 72 264471 44831 55982693
Chest discomfort 61.63 10.04 247 264296 98610 55928914
Blood glucose increased 61.16 10.04 167 264376 74984 55952540
Neoplasm progression 60.19 10.04 38 264505 31978 55995546
Tonsillar ulcer 60.01 10.04 29 264514 272 56027252
Mucosal inflammation 59.46 10.04 68 264475 42742 55984782
Drug ineffective 58.92 10.04 5045 259498 913944 55113580
Clostridium difficile infection 58.86 10.04 27 264516 27171 56000353
Fluid retention 58.16 10.04 103 264440 53975 55973549
Anaphylactic shock 58.03 10.04 229 264314 21511 56006013
Duodenal ulcer 57.61 10.04 113 264430 7042 56020482
Intestinal diaphragm disease 57.31 10.04 21 264522 89 56027435
Vomiting 56.31 10.04 1849 262694 496379 55531145
Lethargy 55.30 10.04 98 264445 51343 55976181
Pneumonia aspiration 54.95 10.04 43 264500 32368 55995156
Asthma 54.90 10.04 308 264235 112462 55915062
No adverse event 54.74 10.04 54 264489 36320 55991204
Injury 53.68 10.04 472 264071 59379 55968145
Adverse event 53.50 10.04 444 264099 54932 55972592
Hyperglycaemia 51.88 10.04 62 264481 38219 55989305
Bronchitis 51.87 10.04 312 264231 111999 55915525
Functional gastrointestinal disorder 51.83 10.04 76 264467 3731 56023793
Posterior reversible encephalopathy syndrome 51.41 10.04 7 264536 15953 56011571
Injection site erythema 51.17 10.04 189 264354 77259 55950265
Blood pressure increased 50.70 10.04 437 264106 144739 55882785
Abdominal pain 50.08 10.04 885 263658 257920 55769604
Chills 50.07 10.04 280 264263 102324 55925200
Sedation 49.90 10.04 54 264489 34800 55992724
Device dislocation 49.61 10.04 22 264521 22584 56004940
Prescribed overdose 49.49 10.04 222 264321 22074 56005450
Angioedema 49.34 10.04 349 264194 41104 55986420
Pancreatitis 49.26 10.04 85 264458 44995 55982529
Premature delivery 48.33 10.04 34 264509 27026 56000498
Small intestine ulcer 48.27 10.04 26 264517 312 56027212
Chronic obstructive pulmonary disease 47.91 10.04 126 264417 57289 55970235
Respiratory distress 47.67 10.04 47 264496 31620 55995904
Influenza 47.56 10.04 258 264285 95003 55932521
Retinitis 47.24 10.04 77 264466 4147 56023377
Syncope 47.16 10.04 306 264237 107893 55919631
Acute myeloid leukaemia 46.98 10.04 11 264532 16961 56010563
Blood potassium decreased 46.91 10.04 68 264475 38604 55988920
Type I hypersensitivity 46.77 10.04 58 264485 2420 56025104
Unevaluable event 46.75 10.04 96 264447 47591 55979933
Hyponatraemia 46.50 10.04 285 264258 101854 55925670
Renal failure neonatal 46.31 10.04 21 264522 168 56027356
Large intestinal stenosis 46.31 10.04 49 264494 1717 56025807
Deep vein thrombosis 46.30 10.04 195 264348 76782 55950742
Diabetes mellitus 46.12 10.04 113 264430 52622 55974902
Dislocation of vertebra 45.40 10.04 87 264456 5328 56022196
Hypomagnesaemia 45.25 10.04 31 264512 24984 56002540
Ductus arteriosus stenosis foetal 44.65 10.04 20 264523 155 56027369
Complication associated with device 44.41 10.04 9 264534 15341 56012183
Incorrect dose administered 44.09 10.04 115 264428 52432 55975092
Drug tolerance decreased 43.98 10.04 151 264392 13260 56014264
Cytomegalovirus infection 43.59 10.04 18 264525 19278 56008246
Dry skin 42.74 10.04 99 264444 47010 55980514
Septic shock 42.49 10.04 145 264398 60690 55966834
Large intestinal ulcer 42.20 10.04 63 264480 3143 56024381
Fat necrosis 41.93 10.04 30 264513 612 56026912
Flushing 41.90 10.04 178 264365 69922 55957602
Injection site bruising 41.75 10.04 73 264470 38448 55989076
Drug abuse 41.45 10.04 170 264373 67440 55960084
Full blood count abnormal 41.32 10.04 38 264505 26424 56001100
Ileal ulcer 41.30 10.04 26 264517 425 56027099
Joint range of motion decreased 41.06 10.04 231 264312 25134 56002390
Agitation 40.90 10.04 131 264412 55905 55971619
Condition aggravated 40.68 10.04 1996 262547 342902 55684622
Joint dislocation 40.38 10.04 164 264379 15609 56011915
Dysphagia 40.32 10.04 223 264320 81724 55945800
Renal failure 39.75 10.04 330 264213 110170 55917354
Orthostatic hypotension 39.66 10.04 59 264484 33140 55994384
Neuroleptic malignant syndrome 39.54 10.04 4 264539 11474 56016050
Liver function test abnormal 39.05 10.04 99 264444 45572 55981952
Ascites 39.03 10.04 73 264470 37471 55990053
Hypervolaemia 38.99 10.04 40 264503 26418 56001106
Metastases to liver 38.72 10.04 27 264516 21559 56005965
Feeling abnormal 38.67 10.04 421 264122 133181 55894343
Neurotoxicity 38.59 10.04 13 264530 15782 56011742
Cellulitis 38.51 10.04 201 264342 74748 55952776
Therapeutic product effect incomplete 38.43 10.04 316 264227 105715 55921809
Myelosuppression 38.28 10.04 17 264526 17438 56010086
Generalised tonic-clonic seizure 38.05 10.04 44 264499 27522 56000002
Gastrointestinal erosion 37.95 10.04 28 264515 600 56026924
Hypercalcaemia 37.92 10.04 38 264505 25373 56002151
Ductus arteriosus premature closure 37.90 10.04 22 264521 308 56027216
Sedation complication 37.88 10.04 5 264538 11667 56015857
Status epilepticus 37.80 10.04 12 264531 15129 56012395
Dyspnoea exertional 37.76 10.04 131 264412 54558 55972966
Nasopharyngitis 37.74 10.04 1330 263213 219629 55807895
Palpitations 37.53 10.04 294 264249 99378 55928146
Chest pain 37.33 10.04 647 263896 189150 55838374
Unresponsive to stimuli 37.30 10.04 57 264486 31668 55995856
Somnolence 37.18 10.04 542 264001 162871 55864653
Urosepsis 37.10 10.04 16 264527 16700 56010824
Bone marrow failure 37.08 10.04 47 264496 28239 55999285
Palmar-plantar erythrodysaesthesia syndrome 36.93 10.04 27 264516 21038 56006486
Facet joint syndrome 36.92 10.04 91 264452 6626 56020898
Laboratory test abnormal 36.77 10.04 37 264506 24658 56002866
Torsade de pointes 36.61 10.04 7 264536 12433 56015091
Injection site necrosis 36.45 10.04 37 264506 1234 56026290
Product quality issue 36.38 10.04 58 264485 31678 55995846
Peripheral swelling 36.24 10.04 1397 263146 233329 55794195
Duodenal ulcer haemorrhage 36.01 10.04 49 264494 2243 56025281
Device issue 35.78 10.04 28 264515 21078 56006446
Adjustment disorder with depressed mood 35.65 10.04 76 264467 5027 56022497
Upper respiratory tract infection 35.62 10.04 193 264350 71095 55956429
Headache 35.54 10.04 2209 262334 556835 55470689
Transplant rejection 35.45 10.04 3 264540 9931 56017593
Hypocalcaemia 35.45 10.04 50 264493 28710 55998814
Neoplasm malignant 35.42 10.04 45 264498 27010 56000514
Vision blurred 35.42 10.04 236 264307 82707 55944817
Ejection fraction decreased 35.34 10.04 25 264518 19816 56007708
Endoscopy abnormal 35.33 10.04 9 264534 5 56027519
Sopor 35.16 10.04 28 264515 20894 56006630
Foetal methotrexate syndrome 35.12 10.04 14 264529 78 56027446
Hallucination 34.42 10.04 117 264426 49032 55978492
Sacroiliitis 34.40 10.04 53 264490 2719 56024805
Nasal congestion 34.39 10.04 142 264401 56228 55971296
Productive cough 34.09 10.04 142 264401 56090 55971434
Tremor 34.08 10.04 384 264159 120705 55906819
Anti-cyclic citrullinated peptide antibody 33.94 10.04 62 264481 3661 56023863
Drug resistance 33.89 10.04 28 264515 20514 56007010
Anaphylactic reaction 33.84 10.04 425 264118 58570 55968954
Oligohydramnios 33.79 10.04 82 264461 5912 56021612
Jejunal ulcer 33.72 10.04 14 264529 88 56027436
Maternal exposure timing unspecified 33.63 10.04 77 264466 5346 56022178
Foot operation 33.50 10.04 84 264459 6183 56021341
Transfusion 33.25 10.04 11 264532 13509 56014015
Lower respiratory tract infection viral 33.17 10.04 29 264514 798 56026726
Intestinal obstruction 33.13 10.04 50 264493 27921 55999603
Feeding disorder 33.10 10.04 127 264416 11773 56015751
Abnormal behaviour 32.99 10.04 28 264515 20244 56007280
Cardiac disorder 32.99 10.04 108 264435 45779 55981745
Haemoglobin decreased 32.97 10.04 438 264105 133699 55893825
Weight decreased 32.93 10.04 870 263673 239844 55787680
Deep vein thrombosis postoperative 32.75 10.04 64 264479 3977 56023547
Depressed level of consciousness 32.69 10.04 145 264398 56288 55971236
Extrapyramidal disorder 32.29 10.04 9 264534 12347 56015177
Confusional state 32.16 10.04 1239 263304 206916 55820608
Abortion spontaneous 32.13 10.04 102 264441 43651 55983873
Psychotic disorder 32.09 10.04 38 264505 23520 56004004
Diabetic ketoacidosis 32.04 10.04 25 264518 18846 56008678
Malaise 31.98 10.04 1408 263135 366452 55661072
Stress 31.97 10.04 155 264388 58755 55968769
Blood calcium decreased 31.67 10.04 39 264504 23730 56003794
Lip dry 31.36 10.04 109 264434 9631 56017893
Atelectasis 31.02 10.04 27 264516 19281 56008243
Progressive multifocal leukoencephalopathy 30.93 10.04 9 264534 12004 56015520
Schizophrenia 30.70 10.04 6 264537 10493 56017031
Porphyria acute 30.68 10.04 29 264514 885 56026639
Encephalopathy 30.65 10.04 76 264467 35249 55992275
Abnormal loss of weight 30.26 10.04 73 264470 5243 56022281
Suicidal ideation 30.15 10.04 154 264389 57588 55969936
Gastritis erosive 30.07 10.04 75 264468 5502 56022022
Overdose 30.02 10.04 335 264208 105495 55922029
Macular degeneration 29.70 10.04 27 264516 18881 56008643
Throat irritation 29.39 10.04 69 264474 32614 55994910
Aspirin-exacerbated respiratory disease 29.23 10.04 28 264515 869 56026655
Pericardial effusion 29.00 10.04 52 264491 27123 56000401
Right ventricular failure 28.70 10.04 21 264522 16358 56011166
Periorbital oedema 28.69 10.04 71 264472 5183 56022341
Injection site pruritus 28.57 10.04 101 264442 41830 55985694
Aggression 28.40 10.04 37 264506 21969 56005555
Erythema 28.32 10.04 539 264004 155400 55872124
Hepatic failure 28.31 10.04 73 264470 33413 55994111
Cytokine release syndrome 28.27 10.04 8 264535 10867 56016657
Respiratory disorder 27.96 10.04 75 264468 33882 55993642
Pulmonary hypertension 27.67 10.04 82 264461 35862 55991662
Bacteraemia 27.44 10.04 20 264523 15611 56011913
Accidental exposure to product 27.36 10.04 46 264497 24601 56002923
X-ray abnormal 27.32 10.04 62 264481 4279 56023245
Injection site reaction 27.24 10.04 143 264400 53104 55974420
Depressed mood 27.24 10.04 84 264459 36275 55991249
Neutropenic sepsis 27.22 10.04 19 264524 15166 56012358
Device related infection 27.01 10.04 38 264505 21842 56005682
Blood pressure fluctuation 26.98 10.04 98 264445 40262 55987262
Thrombosis 26.95 10.04 166 264377 59261 55968263
Breast cancer metastatic 26.89 10.04 20 264523 15449 56012075
Blood glucose decreased 26.85 10.04 30 264513 19057 56008467
Lymphocyte count decreased 26.75 10.04 57 264486 27882 55999642
Therapy cessation 26.62 10.04 55 264488 27209 56000315
Sinus disorder 26.61 10.04 35 264508 20699 56006825
Liver function test increased 26.43 10.04 58 264485 28075 55999449
Multiple sclerosis 26.38 10.04 57 264486 27745 55999779
Spinal stenosis 26.35 10.04 133 264410 13881 56013643
Influenza like illness 26.30 10.04 173 264370 60815 55966709
Haematotoxicity 26.25 10.04 4 264539 8379 56019145
Myocarditis 26.03 10.04 5 264538 8853 56018671
Paranoia 25.97 10.04 9 264534 10735 56016789
Ventricular tachycardia 25.53 10.04 25 264518 16876 56010648
Full blood count decreased 25.53 10.04 44 264499 23305 56004219
Treatment noncompliance 25.42 10.04 74 264469 32549 55994975
Infective pulmonary exacerbation of cystic fibrosis 25.30 10.04 4 264539 8153 56019371
Akathisia 25.18 10.04 5 264538 8647 56018877
Dizziness 25.13 10.04 1479 263064 374661 55652863
Bone disorder 25.07 10.04 33 264510 19510 56008014
Neonatal intestinal perforation 24.99 10.04 8 264535 20 56027504
Gestational diabetes 24.90 10.04 4 264539 8060 56019464
Psoriasis 24.89 10.04 297 264246 92395 55935129
Oral pain 24.87 10.04 54 264489 26239 56001285
Hepatotoxicity 24.76 10.04 70 264473 31083 55996441
Ataxia 24.55 10.04 19 264524 14384 56013140
Breast cancer 24.50 10.04 132 264411 48701 55978823
Rhinorrhoea 24.49 10.04 162 264381 56875 55970649
Heavy menstrual bleeding 24.46 10.04 24 264519 16185 56011339
Second primary malignancy 24.44 10.04 3 264540 7399 56020125
Osteonecrosis of jaw 24.33 10.04 78 264465 33280 55994244
Thrombotic microangiopathy 24.33 10.04 7 264536 9404 56018120
Blood test abnormal 24.27 10.04 15 264528 12769 56014755
Mobility decreased 24.21 10.04 623 263920 98368 55929156
Application site rash 24.21 10.04 42 264501 2381 56025143
Lupus vulgaris 24.11 10.04 37 264506 1892 56025632
Mania 24.06 10.04 12 264531 11508 56016016
Frequent bowel movements 24.01 10.04 25 264518 16399 56011125
Laryngitis 23.97 10.04 129 264414 13801 56013723
Haemorrhage 23.80 10.04 161 264382 56236 55971288
Lung neoplasm malignant 23.76 10.04 28 264515 17368 56010156
Adverse drug reaction 23.66 10.04 434 264109 64698 55962826
Respiratory tract congestion 23.63 10.04 23 264520 15568 56011956
Drug interaction 23.46 10.04 779 263764 208976 55818548
Injection site swelling 23.45 10.04 115 264428 43463 55984061
Obstructive airways disorder 23.40 10.04 28 264515 17254 56010270
Back pain 23.30 10.04 895 263648 236275 55791249
Rotator cuff repair 23.27 10.04 36 264507 1854 56025670
Rhabdomyolysis 23.22 10.04 105 264438 40553 55986971
Feeling cold 23.10 10.04 40 264503 21147 56006377
Seronegative arthritis 22.99 10.04 44 264499 2692 56024832
Injection site mass 22.96 10.04 27 264516 16766 56010758
Haematocrit decreased 22.95 10.04 92 264451 36737 55990787
Cerebral haemorrhage 22.94 10.04 64 264479 28542 55998982
Abdominal rebound tenderness 22.93 10.04 7 264536 14 56027510
Intestinal ulcer 22.81 10.04 28 264515 1156 56026368
Breast cancer female 22.70 10.04 15 264528 12323 56015201
Fear 22.58 10.04 22 264521 14886 56012638
Corneal epithelium defect 22.55 10.04 16 264527 322 56027202
Panniculitis 22.52 10.04 9 264534 9833 56017691
Red blood cell count decreased 22.49 10.04 92 264451 36525 55990999
Haemoptysis 22.37 10.04 58 264485 26502 56001022
Injection site haemorrhage 22.35 10.04 44 264499 22157 56005367
Synostosis 22.31 10.04 9 264534 52 56027472
Cytopenia 22.19 10.04 9 264534 9746 56017778
Emotional distress 22.12 10.04 69 264474 29694 55997830
Small intestinal obstruction 22.01 10.04 28 264515 16797 56010727
Metastases to central nervous system 22.00 10.04 15 264528 12121 56015403
Dysgeusia 22.00 10.04 108 264435 40807 55986717
Diabetes mellitus inadequate control 21.92 10.04 20 264523 13960 56013564
Congenital pulmonary hypertension 21.89 10.04 9 264534 55 56027469
Soft tissue injury 21.88 10.04 32 264511 1567 56025957
Lymphopenia 21.85 10.04 28 264515 16746 56010778
Inappropriate schedule of product administration 21.70 10.04 269 264274 83118 55944406
Neonatal respiratory acidosis 21.65 10.04 12 264531 153 56027371
Muscle spasms 21.63 10.04 486 264057 136885 55890639
Paraesthesia 21.63 10.04 458 264085 130056 55897468
Oropharyngeal pain 21.54 10.04 271 264272 83517 55944007
Lacrimation increased 21.54 10.04 33 264510 18315 56009209
Subdural haematoma 21.54 10.04 19 264524 13480 56014044
Fungal infection 21.47 10.04 81 264462 32912 55994612
Synovial cyst 21.40 10.04 93 264450 9121 56018403
Haematemesis 21.39 10.04 218 264325 28540 55998984
Epilepsy 21.33 10.04 55 264488 25176 56002348
Central nervous system lesion 21.29 10.04 10 264533 9928 56017596
Orbital oedema 21.22 10.04 13 264530 202 56027322
Hepatitis 21.17 10.04 90 264453 35351 55992173
Rheumatoid lung 21.06 10.04 46 264497 3094 56024430
Lymphatic fistula 20.95 10.04 22 264521 764 56026760
Psychomotor hyperactivity 20.86 10.04 10 264533 9810 56017714
Mood swings 20.75 10.04 29 264514 16718 56010806
Hyperhidrosis 20.72 10.04 314 264229 93774 55933750
Ovulation disorder 20.71 10.04 7 264536 22 56027502
Femoral hernia incarcerated 20.61 10.04 22 264521 779 56026745
Arrhythmia 20.40 10.04 90 264453 34993 55992531
Multiple allergies 20.37 10.04 12 264531 10484 56017040
Haemorrhage intracranial 20.29 10.04 18 264525 12737 56014787
Complication of device insertion 20.26 10.04 3 264540 6421 56021103
Tubulointerstitial nephritis 20.23 10.04 141 264402 16524 56011000
Acute respiratory failure 20.23 10.04 76 264467 30918 55996606
Disease recurrence 20.18 10.04 52 264491 23808 56003716
Loss of consciousness 20.14 10.04 377 264166 108972 55918552
Aspiration 20.13 10.04 10 264533 9611 56017913
Clostridium difficile colitis 19.86 10.04 36 264507 18702 56008822
Sinusitis 19.73 10.04 1126 263417 196455 55831069
Herpes zoster 19.67 10.04 245 264298 75644 55951880
Large intestine perforation 19.59 10.04 81 264462 7770 56019754
Exposure during pregnancy 19.51 10.04 805 263738 135537 55891987
Product storage error 19.44 10.04 20 264523 13193 56014331
Blood calcium increased 19.42 10.04 7 264536 8147 56019377
Respiratory arrest 19.40 10.04 76 264467 30549 55996975
Procedural pain 19.35 10.04 29 264514 16242 56011282
Cardiomyopathy 19.32 10.04 29 264514 16229 56011295
Injection site hyperaesthesia 19.31 10.04 8 264535 50 56027474
Femur fracture 19.29 10.04 107 264436 39188 55988336
Creatinine renal clearance decreased 19.28 10.04 24 264519 14535 56012989
Urine abnormality 19.23 10.04 4 264539 6695 56020829
Prescribed underdose 19.21 10.04 164 264379 20453 56007071
Peripheral venous disease 19.19 10.04 96 264447 9983 56017541
Keratopathy 19.16 10.04 18 264525 545 56026979
Drug dependence 19.14 10.04 49 264494 22484 56005040
Ischaemic stroke 19.10 10.04 31 264512 16811 56010713
Immunodeficiency 19.02 10.04 29 264514 16128 56011396
Aphasia 18.94 10.04 76 264467 30339 55997185
Bladder disorder 18.92 10.04 7 264536 8017 56019507
Abdominal distension 18.87 10.04 254 264289 77372 55950152
Pancreatic steatosis 18.82 10.04 23 264520 945 56026579
Arteriovenous fistula occlusion 18.74 10.04 15 264528 364 56027160
Candida infection 18.73 10.04 60 264483 25607 56001917
Failure to thrive 18.70 10.04 4 264539 6566 56020958
Nephrolithiasis 18.69 10.04 101 264442 37234 55990290
Renal impairment 18.59 10.04 267 264276 80446 55947078
Serotonin syndrome 18.59 10.04 63 264480 26427 56001097
Gastric ulcer haemorrhage 18.53 10.04 56 264487 4597 56022927
Muscle tone disorder 18.49 10.04 10 264533 121 56027403
Transaminases increased 18.48 10.04 71 264472 28699 55998825
Skin ulcer 18.48 10.04 106 264437 38502 55989022
Bedridden 18.40 10.04 13 264530 10312 56017212
Femur-fibula-ulna complex 18.38 10.04 5 264538 5 56027519
Urinoma 18.34 10.04 7 264536 34 56027490
Sleep disorder due to a general medical condition 18.20 10.04 10 264533 9080 56018444
Bronchopulmonary aspergillosis 18.20 10.04 8 264535 8256 56019268
Cyanosis neonatal 18.13 10.04 13 264530 266 56027258
Lip ulceration 18.11 10.04 32 264511 1841 56025683
Deafness 17.98 10.04 136 264407 16358 56011166
Pyrexia 17.83 10.04 1710 262833 417063 55610461
Amenorrhoea 17.83 10.04 10 264533 8976 56018548
Metabolic acidosis 17.82 10.04 114 264429 40340 55987184
Nodule 17.81 10.04 38 264505 18581 56008943
Blue toe syndrome 17.81 10.04 15 264528 392 56027132
Drug withdrawal syndrome 17.80 10.04 62 264481 25795 56001729
Gallbladder adenocarcinoma 17.79 10.04 9 264534 94 56027430
Metastases to bone 17.69 10.04 41 264502 19467 56008057
Taste disorder 17.62 10.04 12 264531 9703 56017821
Libido increased 17.58 10.04 26 264517 1286 56026238
Tenderness 17.57 10.04 158 264385 19997 56007527
Heart rate irregular 17.54 10.04 45 264498 20634 56006890
Blood creatinine increased 17.52 10.04 268 264275 79923 55947601
Hot flush 17.50 10.04 138 264405 46588 55980936
Urine porphobilinogen increased 17.46 10.04 4 264539 0 56027524
Multiple organ dysfunction syndrome 17.46 10.04 161 264382 52609 55974915
Tongue disorder 17.41 10.04 13 264530 10023 56017501
Oral candidiasis 17.37 10.04 39 264504 18724 56008800
Dyskinesia 17.33 10.04 74 264469 29034 55998490
Breast cancer stage I 17.32 10.04 4 264539 6226 56021298
Upper limb fracture 17.27 10.04 34 264509 17121 56010403
Hypochromic anaemia 17.25 10.04 31 264512 1807 56025717
Coagulopathy 17.24 10.04 39 264504 18677 56008847
Burning sensation 17.24 10.04 146 264397 48550 55978974
Crying 17.17 10.04 48 264495 21392 56006132
Punctate keratitis 17.17 10.04 17 264526 550 56026974
Adactyly 17.13 10.04 7 264536 42 56027482
Cardiac murmur 17.07 10.04 17 264526 11384 56016140
Gallbladder disorder 16.90 10.04 35 264508 17299 56010225
Acute respiratory distress syndrome 16.89 10.04 50 264493 21876 56005648
Lymphocyte stimulation test positive 16.88 10.04 16 264527 490 56027034
Aspergillus infection 16.80 10.04 7 264536 7458 56020066
Adrenal insufficiency 16.78 10.04 30 264513 15667 56011857
Device occlusion 16.77 10.04 5 264538 6564 56020960
Soft tissue infection 16.75 10.04 32 264511 1955 56025569
Complications of intestinal transplant 16.72 10.04 5 264538 9 56027515
Upper-airway cough syndrome 16.67 10.04 12 264531 9426 56018098
Autoimmune disorder 16.58 10.04 85 264458 8924 56018600
Urinary incontinence 16.54 10.04 77 264466 29508 55998016
Uterine perforation 16.52 10.04 5 264538 6500 56021024
Intentional overdose 16.52 10.04 223 264320 67894 55959630
Spinal pain 16.52 10.04 104 264439 11780 56015744
Cushingoid 16.50 10.04 7 264536 7377 56020147
Dementia 16.43 10.04 35 264508 17123 56010401
Thyroid disorder 16.43 10.04 25 264518 13913 56013611
Creutzfeldt-Jakob disease 16.40 10.04 10 264533 154 56027370
Therapy change 16.34 10.04 3 264540 5485 56022039
Electrolyte imbalance 16.27 10.04 38 264505 17995 56009529
Pulmonary mass 16.27 10.04 46 264497 20424 56007100
Peritonitis 16.23 10.04 131 264412 16071 56011453
Visual impairment 16.21 10.04 248 264295 73954 55953570
Colitis erosive 16.20 10.04 8 264535 79 56027445
Genital haemorrhage 16.16 10.04 6 264537 6856 56020668
Kidney infection 16.16 10.04 47 264496 20678 56006846
Caesarean section 16.10 10.04 32 264511 16059 56011465
Vasoconstriction 16.07 10.04 16 264527 521 56027003
Pre-eclampsia 16.05 10.04 10 264533 8476 56019048
Tachypnoea 16.04 10.04 30 264513 15400 56012124
Myalgia 16.03 10.04 485 264058 131540 55895984
Adverse reaction 16.02 10.04 87 264456 9340 56018184
Infusion site pain 15.92 10.04 25 264518 13737 56013787
Vaccination site reaction 15.89 10.04 9 264534 120 56027404
Central pain syndrome 15.87 10.04 11 264532 213 56027311
Libido disorder 15.77 10.04 7 264536 53 56027471
Enterococcal infection 15.75 10.04 7 264536 7177 56020347
Dysarthria 15.66 10.04 115 264428 39435 55988089
Blood pressure abnormal 15.62 10.04 25 264518 13635 56013889
Skin discolouration 15.56 10.04 96 264447 34260 55993264
Renal cancer 15.47 10.04 3 264540 5276 56022248
Device breakage 15.34 10.04 15 264528 10132 56017392
Drug level decreased 15.30 10.04 7 264536 7057 56020467
Bacterial infection 15.25 10.04 37 264506 17293 56010231
Injection site abscess 15.25 10.04 22 264521 1064 56026460
Staphylococcal bacteraemia 15.18 10.04 3 264540 5206 56022318
Hypovolaemia 15.17 10.04 14 264529 9721 56017803
International normalised ratio increased 15.16 10.04 133 264410 43908 55983616
Gastrointestinal toxicity 15.15 10.04 5 264538 6151 56021373
Diffuse large B-cell lymphoma 15.13 10.04 7 264536 7009 56020515
Cholestasis 15.07 10.04 70 264473 26843 56000681
Muscle spasticity 15.03 10.04 46 264497 19914 56007610
Kounis syndrome 14.98 10.04 24 264519 1274 56026250
Erythematotelangiectatic rosacea 14.96 10.04 5 264538 15 56027509
Chronic kidney disease 14.93 10.04 126 264417 41930 55985594
Nervous system disorder 14.91 10.04 36 264507 16853 56010671
Peripheral sensory neuropathy 14.90 10.04 7 264536 6949 56020575
Pancreatitis acute 14.88 10.04 64 264479 25060 56002464
Joint injury 14.80 10.04 66 264477 25588 56001936
Mood altered 14.75 10.04 25 264518 13330 56014194
Dysphonia 14.74 10.04 126 264417 41821 55985703
Vascular device infection 14.74 10.04 4 264539 5586 56021938
Gastroenteritis viral 14.72 10.04 48 264495 20376 56007148
Fistula 14.69 10.04 12 264531 8843 56018681
Encephalitis 14.67 10.04 10 264533 8080 56019444
Gastrointestinal ulcer 14.66 10.04 29 264514 1818 56025706
Anterior chamber cell 14.64 10.04 15 264528 506 56027018
Basal ganglion degeneration 14.63 10.04 14 264529 434 56027090
Cholelithiasis 14.57 10.04 117 264426 39347 55988177
Device malfunction 14.56 10.04 34 264509 16102 56011422
Homicide 14.48 10.04 13 264530 371 56027153
Tardive dyskinesia 14.46 10.04 10 264533 8021 56019503
Meralgia paraesthetica 14.39 10.04 12 264531 309 56027215
Pruritus 14.39 10.04 1699 262844 314924 55712600
Nail operation 14.37 10.04 18 264525 759 56026765
Retching 14.34 10.04 26 264517 13504 56014020
Granuloma 14.33 10.04 4 264539 5483 56022041
Diverticulitis 14.32 10.04 104 264439 35748 55991776
Sebaceous gland infection 14.30 10.04 9 264534 147 56027377
Myopathy 14.27 10.04 15 264528 9797 56017727
Suspected suicide 14.25 10.04 4 264539 5462 56022062
Immunosuppression 14.23 10.04 10 264533 7954 56019570
Haemorrhoids 14.22 10.04 48 264495 20158 56007366
Glycosylated haemoglobin increased 14.17 10.04 19 264524 11146 56016378
Bone pain 14.17 10.04 159 264384 50026 55977498
Pneumonia viral 14.15 10.04 8 264535 7150 56020374
Therapy interrupted 14.15 10.04 67 264476 25558 56001966
Hip fracture 14.04 10.04 72 264471 26901 56000623
Congenital tricuspid valve atresia 14.03 10.04 6 264537 41 56027483
Tooth disorder 14.00 10.04 67 264476 25486 56002038
Device difficult to use 13.98 10.04 18 264525 10743 56016781
Loss of personal independence in daily activities 13.93 10.04 284 264259 81085 55946439
Basal cell carcinoma 13.89 10.04 66 264477 25155 56002369
Mental impairment 13.88 10.04 24 264519 12698 56014826
Normal newborn 13.86 10.04 9 264534 7461 56020063
Lupus-like syndrome 13.85 10.04 103 264440 12324 56015200
Epstein-Barr virus infection 13.83 10.04 9 264534 7454 56020070
Skin cancer 13.79 10.04 17 264526 10338 56017186
Renal disorder 13.78 10.04 82 264461 29523 55998001
Granulocytopenia 13.77 10.04 4 264539 5340 56022184
Salivary hypersecretion 13.76 10.04 8 264535 7042 56020482
Walking aid user 13.73 10.04 77 264466 8366 56019158
Injection site warmth 13.68 10.04 29 264514 14214 56013310
Papulopustular rosacea 13.68 10.04 5 264538 21 56027503
Acne 13.68 10.04 52 264491 21084 56006440
Pulseless electrical activity 13.67 10.04 8 264535 7016 56020508
Emotional disorder 13.60 10.04 23 264520 12272 56015252
Injection site rash 13.55 10.04 38 264505 16920 56010604
Palatal oedema 13.53 10.04 14 264529 478 56027046
Haemophagocytic lymphohistiocytosis 13.51 10.04 15 264528 9557 56017967
Arterial haemorrhage 13.49 10.04 26 264517 1599 56025925
Porphyria 13.45 10.04 9 264534 164 56027360
Pyoderma streptococcal 13.45 10.04 4 264539 7 56027517
Wound infection pseudomonas 13.41 10.04 23 264520 1292 56026232
Multiple fractures 13.41 10.04 9 264534 7332 56020192
Dysuria 13.33 10.04 87 264456 30642 55996882
Acquired porphyria 13.32 10.04 5 264538 23 56027501
Porphyrins urine increased 13.32 10.04 5 264538 23 56027501
Fear of injection 13.29 10.04 7 264536 6508 56021016
Wrist deformity 13.24 10.04 28 264515 1842 56025682
Conjunctival hyperaemia 13.23 10.04 31 264512 2185 56025339
Hypertransaminasaemia 13.13 10.04 3 264540 4704 56022820
Application site eczema 13.10 10.04 3 264540 0 56027524
Pseudodiverticular disease 13.10 10.04 3 264540 0 56027524
Dystonia 13.04 10.04 24 264519 12397 56015127
Blood glucose abnormal 13.02 10.04 9 264534 7219 56020305
Anal erosion 12.98 10.04 5 264538 25 56027499
Product substitution issue 12.98 10.04 31 264512 14568 56012956
Hypogammaglobulinaemia 12.97 10.04 7 264536 6419 56021105
Myoclonus 12.96 10.04 33 264510 15170 56012354
Exercise tolerance decreased 12.96 10.04 4 264539 5134 56022390
Oedema peripheral 12.95 10.04 665 263878 170589 55856935
Ulcer 12.88 10.04 58 264485 22427 56005097
Bone marrow oedema 12.87 10.04 20 264523 1034 56026490
Menstruation irregular 12.86 10.04 7 264536 6389 56021135
Application site injury 12.83 10.04 5 264538 26 56027498
Tumour lysis syndrome 12.82 10.04 11 264532 7912 56019612
Erythema induratum 12.77 10.04 9 264534 179 56027345
Drug level increased 12.77 10.04 52 264491 20673 56006851
Diverticulum intestinal 12.73 10.04 62 264481 6378 56021146
Blood bilirubin increased 12.73 10.04 98 264445 33256 55994268
Iris transillumination defect 12.71 10.04 7 264536 88 56027436
Haemolysis 12.61 10.04 7 264536 6321 56021203
Intestinal haemorrhage 12.58 10.04 41 264502 3505 56024019
Fracture 12.54 10.04 43 264500 17975 56009549
Oesophageal carcinoma recurrent 12.52 10.04 5 264538 28 56027496
Pharyngo-oesophageal diverticulum 12.50 10.04 4 264539 10 56027514
Metabolic disorder 12.49 10.04 5 264538 5456 56022068
Cystitis 12.45 10.04 159 264384 48879 55978645
Exostosis 12.45 10.04 116 264427 14827 56012697
Reticulocytosis 12.44 10.04 8 264535 136 56027388
Hepatic cytolysis 12.43 10.04 20 264523 10886 56016638
Viral upper respiratory tract infection 12.42 10.04 67 264476 7175 56020349
Tissue infiltration 12.40 10.04 15 264528 610 56026914
Spinal cord infection 12.36 10.04 15 264528 612 56026912
Catheter site infection 12.35 10.04 3 264540 4511 56023013
Staphylococcal infection 12.34 10.04 115 264428 37503 55990021
Complication of device removal 12.31 10.04 3 264540 4501 56023023
Glaucoma 12.30 10.04 41 264502 17288 56010236
Injection site urticaria 12.30 10.04 26 264517 12757 56014767
Spinal fracture 12.26 10.04 38 264505 16386 56011138
Application site ulcer 12.25 10.04 7 264536 95 56027429
Congestive cardiomyopathy 12.25 10.04 6 264537 5813 56021711
Porphyrins stool increased 12.24 10.04 5 264538 30 56027494
Irritability 12.22 10.04 85 264458 29503 55998021
Partial seizures 12.22 10.04 5 264538 5385 56022139
Eye irritation 12.19 10.04 47 264496 18981 56008543
Transient ischaemic attack 12.19 10.04 100 264443 33477 55994047
Hyperammonaemia 12.18 10.04 4 264539 4936 56022588
Alanine aminotransferase increased 12.14 10.04 341 264202 93321 55934203
Pneumothorax 12.12 10.04 33 264510 14834 56012690
Pain in jaw 12.04 10.04 125 264418 39911 55987613
Respiratory acidosis 12.02 10.04 7 264536 6156 56021368
Parotid gland enlargement 12.02 10.04 17 264526 807 56026717
Onychomadesis 12.01 10.04 49 264494 4672 56022852
Pulmonary thrombosis 12.01 10.04 12 264531 8025 56019499
Meteoropathy 11.97 10.04 4 264539 12 56027512
Neurological procedural complication 11.97 10.04 4 264539 12 56027512
Alpha tumour necrosis factor increased 11.97 10.04 5 264538 32 56027492
Sinus bradycardia 11.96 10.04 29 264514 13557 56013967
Coordination abnormal 11.87 10.04 26 264517 12595 56014929
Joint stiffness 11.82 10.04 233 264310 35192 55992332
Cardiac massage 11.73 10.04 4 264539 13 56027511
Immune reconstitution inflammatory syndrome 11.72 10.04 6 264537 5668 56021856
Vertigo 11.71 10.04 183 264360 54389 55973135
Nervousness 11.67 10.04 84 264459 28931 55998593
Abortion induced 11.66 10.04 17 264526 9628 56017896
Colitis ulcerative 11.65 10.04 67 264476 24324 56003200
Blood magnesium decreased 11.55 10.04 24 264519 11850 56015674
Alanine aminotransferase abnormal 11.55 10.04 3 264540 4312 56023212
Hypoproteinaemia 11.54 10.04 27 264516 1901 56025623
Underdose 11.49 10.04 65 264478 23692 56003832
Unintended pregnancy 11.47 10.04 5 264538 5186 56022338
Pneumonitis 11.46 10.04 94 264449 31470 55996054
Skin fissures 11.45 10.04 17 264526 9556 56017968
Hyperlipidaemia 11.43 10.04 45 264498 18064 56009460
Device leakage 11.40 10.04 8 264535 6367 56021157
Peptic ulcer 11.34 10.04 44 264499 4100 56023424
Perforation bile duct 11.30 10.04 4 264539 15 56027509
Blood pressure systolic increased 11.28 10.04 130 264413 40706 55986818
Oesophagitis ulcerative 11.28 10.04 13 264530 502 56027022
Immune system disorder 11.23 10.04 15 264528 8812 56018712
Brain oedema 11.16 10.04 29 264514 13242 56014282
Pollakiuria 11.11 10.04 71 264472 25131 56002393
Gastrooesophageal reflux disease 11.08 10.04 302 264241 82955 55944569
Venous valve ruptured 11.03 10.04 3 264540 3 56027521
Anger 11.02 10.04 24 264519 11648 56015876
Acute graft versus host disease 10.99 10.04 3 264540 4172 56023352
Paranasal cyst 10.98 10.04 11 264532 361 56027163
Hemiplegia 10.98 10.04 14 264529 8390 56019134
White blood cell count abnormal 10.98 10.04 7 264536 5860 56021664
Electrocardiogram QRS complex prolonged 10.97 10.04 6 264537 5461 56022063
Therapeutic response decreased 10.96 10.04 178 264365 52580 55974944
Intentional product misuse 10.95 10.04 173 264370 51331 55976193
Head titubation 10.92 10.04 16 264527 785 56026739
Necrotising fasciitis 10.90 10.04 33 264510 2712 56024812
Appetite disorder 10.86 10.04 9 264534 6584 56020940
Stillbirth 10.85 10.04 8 264535 6206 56021318
Bone lesion 10.83 10.04 6 264537 5424 56022100
Joint arthroplasty 10.82 10.04 32 264511 2596 56024928
Body temperature decreased 10.80 10.04 46 264497 18062 56009462
Breath sounds abnormal 10.76 10.04 16 264527 8991 56018533
Limb discomfort 10.74 10.04 77 264466 26545 56000979
Osteoporosis 10.69 10.04 176 264367 51876 55975648
Hypothermia 10.68 10.04 27 264516 12443 56015081
Cardiogenic shock 10.67 10.04 40 264503 16285 56011239
Heart rate decreased 10.67 10.04 130 264413 40297 55987227
Delusion 10.63 10.04 23 264520 11192 56016332
Thinking abnormal 10.63 10.04 19 264524 9922 56017602
Atrioventricular block 10.62 10.04 10 264533 6877 56020647
Seroma 10.62 10.04 26 264517 1885 56025639
Sinus headache 10.61 10.04 5 264538 4953 56022571
Lip scab 10.57 10.04 3 264540 4 56027520
Neonatal gastrointestinal haemorrhage 10.55 10.04 4 264539 19 56027505
Vaginal ulceration 10.48 10.04 11 264532 382 56027142
Gastrointestinal procedural complication 10.47 10.04 8 264535 181 56027343
Accidental overdose 10.43 10.04 55 264488 20406 56007118
Feeling hot 10.42 10.04 136 264407 41651 55985873
Blood pressure diastolic decreased 10.39 10.04 51 264492 19272 56008252
pH body fluid decreased 10.39 10.04 4 264539 20 56027504
Aspartate aminotransferase increased 10.38 10.04 302 264241 82300 55945224
Feeling jittery 10.38 10.04 26 264517 12020 56015504
Analgesic drug level increased 10.35 10.04 25 264518 1797 56025727
Hypophagia 10.34 10.04 192 264351 28684 55998840
Pharyngitis streptococcal 10.29 10.04 18 264525 9480 56018044
Pneumonitis chemical 10.29 10.04 8 264535 186 56027338
Hemiparesis 10.28 10.04 59 264484 21431 56006093
Atrial flutter 10.28 10.04 17 264526 9152 56018372
Stress ulcer 10.25 10.04 5 264538 48 56027476
Myelodysplastic syndrome 10.21 10.04 41 264502 16365 56011159
Anosmia 10.18 10.04 4 264539 4415 56023109
Motor dysfunction 10.18 10.04 18 264525 9439 56018085
Musculoskeletal disorder 10.16 10.04 136 264407 19011 56008513
Extravascular haemolysis 10.16 10.04 5 264538 49 56027475
Restless legs syndrome 10.14 10.04 43 264500 16904 56010620
Anaesthesia 10.11 10.04 11 264532 398 56027126
Carbohydrate antigen 15-3 10.09 10.04 6 264537 88 56027436
Cholecystitis chronic 10.09 10.04 19 264524 9729 56017795

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
Embolia cutis medicamentosa 257.23 10.40 68 77415 167 31619694
Ankylosing spondylitis 242.47 10.40 161 77322 5720 31614141
Death 241.28 10.40 318 77165 360251 31259610
Melaena 214.34 10.40 327 77156 32327 31587534
Gastric ulcer 202.99 10.40 213 77270 14421 31605440
Duodenal ulcer 142.38 10.40 146 77337 9618 31610243
Onychoclasis 131.07 10.40 71 77412 1724 31618137
Off label use 124.85 10.40 434 77049 346840 31273021
Febrile neutropenia 119.74 10.40 75 77408 121774 31498087
Kounis syndrome 115.93 10.40 69 77414 2015 31617846
Angioedema 106.08 10.40 246 77237 33372 31586489
Anaphylactic shock 103.32 10.40 149 77334 13996 31605865
Inflammation 100.59 10.40 203 77280 25038 31594823
Gastritis erosive 98.37 10.40 93 77390 5546 31614315
Neutropenia 93.22 10.40 124 77359 140240 31479621
Large intestinal stenosis 90.73 10.40 52 77431 1413 31618448
Gastric ulcer haemorrhage 86.53 10.40 83 77400 5040 31614821
Arthralgia 84.96 10.40 647 76836 150777 31469084
Pain 81.93 10.40 755 76728 186004 31433857
Large intestinal ulcer 80.70 10.40 52 77431 1753 31618108
Tooth loss 80.14 10.40 69 77414 3639 31616222
Psoriatic arthropathy 75.77 10.40 157 77326 19726 31600135
Urticaria 69.65 10.40 302 77181 57215 31562646
Lymphoma 69.52 10.40 108 77375 10835 31609026
Pruritus 69.14 10.40 533 76950 124634 31495227
Intestinal diaphragm disease 68.50 10.40 25 77458 224 31619637
Duodenal ulcer perforation 67.51 10.40 44 77439 1513 31618348
Neck pain 67.22 10.40 163 77320 22747 31597114
Plasma cell myeloma 67.18 10.40 27 77456 56504 31563357
Joint swelling 63.51 10.40 279 77204 53152 31566709
Musculoskeletal stiffness 62.86 10.40 233 77250 41092 31578769
Gastric haemorrhage 62.61 10.40 97 77386 9708 31610153
Cardiac failure congestive 62.58 10.40 61 77422 79326 31540535
Anaphylactic reaction 61.29 10.40 185 77298 29368 31590493
Back pain 60.45 10.40 466 77017 108947 31510914
Haematemesis 60.34 10.40 168 77315 25485 31594376
Type I hypersensitivity 59.26 10.40 36 77447 1092 31618769
Sacroiliitis 57.96 10.40 38 77445 1320 31618541
Pyloric stenosis 57.81 10.40 31 77452 737 31619124
Upper gastrointestinal haemorrhage 57.69 10.40 155 77328 23028 31596833
Thrombocytopenia 56.90 10.40 170 77313 142577 31477284
Macrocephaly 55.73 10.40 26 77457 454 31619407
Abdominal pain upper 55.20 10.40 305 77178 63697 31556164
Tubulointerstitial nephritis and uveitis syndrome 52.81 10.40 16 77467 74 31619787
Fractional exhaled nitric oxide increased 51.79 10.40 27 77456 605 31619256
Toxicity to various agents 51.65 10.40 248 77235 181239 31438622
C-reactive protein increased 50.39 10.40 244 77239 48406 31571455
Metastases to stomach 49.57 10.40 15 77468 69 31619792
Application site rash 49.28 10.40 28 77455 748 31619113
Periorbital oedema 48.97 10.40 51 77432 3420 31616441
Antidepressant drug level above therapeutic 48.69 10.40 19 77464 208 31619653
Acute kidney injury 48.65 10.40 956 76527 278758 31341103
Gastric ulcer perforation 47.95 10.40 30 77453 960 31618901
Disease progression 47.69 10.40 93 77390 90371 31529490
Analgesic drug level above therapeutic 46.98 10.40 20 77463 278 31619583
Spinal pain 45.88 10.40 60 77423 5135 31614726
Arthritis 43.83 10.40 157 77326 27228 31592633
Mucosal erosion 42.73 10.40 26 77457 791 31619070
Head discomfort 42.43 10.40 49 77434 3690 31616171
Sensation of foreign body 42.12 10.40 38 77445 2133 31617728
Myoglobin blood increased 41.58 10.40 40 77443 2437 31617424
Ductus arteriosus premature closure 41.10 10.40 17 77466 219 31619642
Muscle swelling 40.46 10.40 19 77464 337 31619524
Ligament calcification 38.83 10.40 16 77467 204 31619657
Aspirin-exacerbated respiratory disease 38.58 10.40 19 77464 376 31619485
Seronegative arthritis 38.49 10.40 26 77457 950 31618911
Plantar fasciitis 36.84 10.40 31 77452 1584 31618277
Hospitalisation 36.17 10.40 41 77442 49766 31570095
Erythema 36.12 10.40 327 77156 80078 31539783
Injection site necrosis 35.93 10.40 18 77465 370 31619491
Sepsis 35.82 10.40 221 77262 151708 31468153
Product dose omission issue 35.71 10.40 135 77348 105451 31514410
Atrial fibrillation 35.62 10.40 150 77333 113633 31506228
Gastrointestinal erosion 35.41 10.40 18 77465 382 31619479
Ulcerative keratitis 35.10 10.40 30 77453 1566 31618295
Nephrotic syndrome 34.92 10.40 62 77421 6941 31612920
Uveitis 34.84 10.40 61 77422 6755 31613106
Erythema multiforme 34.66 10.40 67 77416 8004 31611857
Bronchospasm 33.68 10.40 75 77408 9897 31609964
Neoplasm malignant 33.30 10.40 112 77371 18819 31601042
Glomerulonephritis minimal lesion 32.79 10.40 18 77465 449 31619412
Psoriasis 32.18 10.40 210 77273 46509 31573352
Drug tolerance decreased 32.18 10.40 30 77453 1757 31618104
Cerebrovascular accident 32.11 10.40 94 77389 79390 31540471
Pneumonia 31.86 10.40 603 76880 334709 31285152
Blood pressure measurement 31.60 10.40 13 77470 165 31619696
Exostosis 31.44 10.40 43 77440 3843 31616018
Cerebral atrophy congenital 31.14 10.40 10 77473 58 31619803
Corneal thinning 30.46 10.40 12 77471 135 31619726
Hypomagnesaemia 30.44 10.40 5 77478 19053 31600808
Duodenal ulcer haemorrhage 30.36 10.40 47 77436 4699 31615162
Mastoid abscess 30.10 10.40 6 77477 0 31619861
Peritonitis 29.95 10.40 94 77389 15233 31604628
Drug interaction 29.79 10.40 693 76790 207850 31412011
Peptic ulcer 29.64 10.40 34 77449 2542 31617319
Gastrointestinal haemorrhage 29.43 10.40 320 77163 82229 31537632
Blister 29.31 10.40 115 77368 20821 31599040
Faeces discoloured 29.23 10.40 87 77396 13699 31606162
Secretion discharge 28.98 10.40 47 77436 4890 31614971
Toxic epidermal necrolysis 28.77 10.40 109 77374 19415 31600446
Pancytopenia 28.64 10.40 113 77370 87203 31532658
Erosive duodenitis 28.51 10.40 25 77458 1351 31618510
Conjunctival hyperaemia 28.50 10.40 31 77452 2185 31617676
Lymphocyte stimulation test positive 28.40 10.40 19 77464 683 31619178
Intestinal atony 28.39 10.40 8 77475 27 31619834
Nephrolithiasis 28.21 10.40 137 77346 27202 31592659
Haematochezia 27.94 10.40 182 77301 40282 31579579
Tubulointerstitial nephritis 27.87 10.40 104 77379 18392 31601469
Alopecia 27.63 10.40 112 77371 20583 31599278
Cytokine release syndrome 27.41 10.40 4 77479 16638 31603223
Fibromyalgia 27.10 10.40 34 77449 2792 31617069
Blood urea increased 26.85 10.40 141 77342 28871 31590990
Application site reaction 26.46 10.40 15 77468 399 31619462
Gastritis 26.44 10.40 109 77374 20183 31599678
Microcytic anaemia 26.41 10.40 29 77454 2066 31617795
Oral pruritus 25.87 10.40 13 77470 269 31619592
Gingivitis ulcerative 25.27 10.40 8 77475 44 31619817
Malignant mesenteric neoplasm 25.27 10.40 8 77475 44 31619817
Nerve stimulation test abnormal 25.08 10.40 5 77478 0 31619861
Hypotension 25.01 10.40 351 77132 204267 31415594
Application site swelling 24.90 10.40 12 77471 226 31619635
Blood lactate dehydrogenase increased 24.75 10.40 107 77376 20232 31599629
Platelet dysfunction 24.52 10.40 12 77471 234 31619627
Cytomegalovirus infection 24.52 10.40 15 77468 24692 31595169
Neurotoxicity 24.32 10.40 5 77478 16221 31603640
Nightmare 24.24 10.40 75 77408 12062 31607799
Sciatic nerve injury 24.15 10.40 9 77474 86 31619775
Corneal perforation 24.11 10.40 11 77472 182 31619679
Fatigue 24.04 10.40 630 76853 334576 31285285
Anuria 23.79 10.40 65 77418 9749 31610112
Laryngeal discomfort 23.69 10.40 11 77472 190 31619671
Angiocardiogram 23.69 10.40 11 77472 190 31619671
Cardiac septal defect 23.68 10.40 12 77471 253 31619608
Hyperhidrosis 23.44 10.40 260 77223 67133 31552728
Migraine 23.28 10.40 82 77401 14098 31605763
Deep vein thrombosis 22.98 10.40 74 77409 60662 31559199
Leukopenia 22.91 10.40 69 77414 57759 31562102
Disability 22.90 10.40 41 77442 4620 31615241
Neuropathy peripheral 22.88 10.40 101 77382 75548 31544313
Electrocardiogram QT prolonged 22.77 10.40 36 77447 37951 31581910
Platelet function test abnormal 22.71 10.40 9 77474 103 31619758
Corneal epithelium defect 22.62 10.40 13 77470 355 31619506
Medium-chain acyl-coenzyme A dehydrogenase deficiency 22.34 10.40 7 77476 37 31619824
Renal failure neonatal 22.25 10.40 9 77474 109 31619752
Swelling 22.22 10.40 162 77321 37196 31582665
Fragile X syndrome 22.18 10.40 7 77476 38 31619823
Product administered at inappropriate site 22.16 10.40 25 77458 1835 31618026
Jejunal ulcer perforation 22.08 10.40 8 77475 70 31619791
Palmoplantar pustulosis 21.89 10.40 9 77474 114 31619747
Inflammatory bowel disease 21.88 10.40 29 77454 2514 31617347
Mental status changes 21.64 10.40 34 77449 35934 31583927
Shock 21.61 10.40 111 77372 22534 31597327
Leptotrichia infection 21.60 10.40 8 77475 75 31619786
Subacute endocarditis 21.60 10.40 7 77476 42 31619819
Iris hypopigmentation 21.60 10.40 7 77476 42 31619819
Weight bearing difficulty 21.14 10.40 18 77465 935 31618926
Mast cell activation syndrome 21.11 10.40 10 77473 181 31619680
Hypoaldosteronism 21.11 10.40 10 77473 181 31619680
Right-to-left cardiac shunt 21.06 10.40 8 77475 81 31619780
Factor VIII deficiency 20.89 10.40 9 77474 129 31619732
Anorgasmia 20.69 10.40 16 77467 724 31619137
Cryopyrin associated periodic syndrome 20.55 10.40 8 77475 87 31619774
Gastric perforation 20.45 10.40 27 77456 2332 31617529
Intervertebral disc compression 20.27 10.40 11 77472 268 31619593
Duodenal stenosis 20.25 10.40 10 77473 199 31619662
Suicide attempt 20.17 10.40 158 77325 37090 31582771
Hypoglycaemia 20.03 10.40 61 77422 50885 31568976
Body mass index abnormal 19.89 10.40 9 77474 146 31619715
Pulmonary embolism 19.61 10.40 118 77365 81528 31538333
Completed suicide 19.58 10.40 137 77346 91377 31528484
Trisomy 8 19.55 10.40 7 77476 59 31619802
Intentional product use issue 19.46 10.40 59 77424 49288 31570573
Application site erythema 19.44 10.40 25 77458 2104 31617757
Omental necrosis 19.42 10.40 6 77477 30 31619831
Application site eczema 19.29 10.40 5 77478 11 31619850
Gastrointestinal ulcer 19.20 10.40 22 77461 1643 31618218
Seizure 19.14 10.40 154 77329 99614 31520247
Mesenteric neoplasm 19.10 10.40 6 77477 32 31619829
Intestinal congestion 18.99 10.40 5 77478 12 31619849
Eastern Cooperative Oncology Group performance status 18.95 10.40 6 77477 33 31619828
Necrotising fasciitis 18.87 10.40 32 77451 3454 31616407
Kidney duplex 18.85 10.40 12 77471 396 31619465
Joint space narrowing 18.61 10.40 8 77475 114 31619747
Neuroleptic malignant syndrome 18.54 10.40 9 77474 16860 31603001
Tissue infiltration 18.33 10.40 7 77476 72 31619789
Eschar 18.25 10.40 14 77469 626 31619235
Pseudarthrosis 18.24 10.40 7 77476 73 31619788
Contraindicated product administered 18.23 10.40 96 77387 19676 31600185
Secondary amyloidosis 17.99 10.40 7 77476 76 31619785
Face oedema 17.96 10.40 62 77421 10554 31609307
Atrial septal defect 17.92 10.40 47 77436 6880 31612981
Cardiogenic shock 17.89 10.40 17 77466 22391 31597470
Hypoxia 17.87 10.40 63 77420 50250 31569611
Twin pregnancy 17.83 10.40 4 77479 3 31619858
Hypoosmolar state 17.75 10.40 7 77476 79 31619782
Nasopharyngitis 17.63 10.40 234 77249 63011 31556850
Acute myeloid leukaemia 17.62 10.40 12 77471 18660 31601201
Incorrect product administration duration 17.61 10.40 35 77448 4267 31615594
Musculoskeletal pain 17.53 10.40 129 77354 29699 31590162
Abdominal lymphadenopathy 17.50 10.40 15 77468 786 31619075
Oropharyngeal discomfort 17.41 10.40 27 77456 2704 31617157
Cytopenia 17.34 10.40 3 77480 11007 31608854
Intestinal ulcer 17.16 10.40 15 77468 807 31619054
Gastritis haemorrhagic 17.16 10.40 19 77464 1366 31618495
Hypervolaemia 16.86 10.40 12 77471 18239 31601622
Mobility decreased 16.84 10.40 120 77363 27349 31592512
Dactylitis 16.84 10.40 15 77468 828 31619033
Pallor 16.80 10.40 103 77380 22321 31597540
Bacteroides infection 16.66 10.40 7 77476 94 31619767
Grip strength decreased 16.64 10.40 26 77457 2620 31617241
Mallory-Weiss syndrome 16.51 10.40 18 77465 1272 31618589
Drug resistance 16.28 10.40 20 77463 23433 31596428
Oropharyngeal pain 16.20 10.40 132 77351 31351 31588510
Muscle abscess 16.15 10.40 12 77471 511 31619350
Arthritis bacterial 16.04 10.40 35 77448 4555 31615306
Large intestine perforation 16.01 10.40 48 77435 7588 31612273
Red blood cell sedimentation rate decreased 15.86 10.40 6 77477 60 31619801
Gastric mucosa erythema 15.82 10.40 9 77474 241 31619620
Respiratory failure 15.81 10.40 165 77318 101284 31518577
Stevens-Johnson syndrome 15.78 10.40 84 77399 17288 31602573
Intestinal metaplasia 15.72 10.40 5 77478 28 31619833
Wound secretion 15.70 10.40 24 77459 2373 31617488
Cardio-respiratory arrest 15.67 10.40 69 77414 51657 31568204
Application site vesicles 15.67 10.40 12 77471 535 31619326
Ureteral disorder 15.60 10.40 8 77475 173 31619688
Cognitive disorder 15.53 10.40 23 77460 24900 31594961
Lipoma 15.49 10.40 19 77464 1524 31618337
Gastric mucosal lesion 15.48 10.40 12 77471 545 31619316
Gastrointestinal mucosal exfoliation 15.44 10.40 7 77476 114 31619747
Duodenal perforation 15.44 10.40 17 77466 1215 31618646
Abdominal pain 15.31 10.40 466 77017 145486 31474375
Diabetes mellitus 15.30 10.40 53 77430 42503 31577358
Application site oedema 15.29 10.40 5 77478 31 31619830
Ciliary hyperaemia 15.29 10.40 5 77478 31 31619830
CADASIL 15.27 10.40 6 77477 67 31619794
Full blood count decreased 15.12 10.40 11 77472 16529 31603332
Product used for unknown indication 15.12 10.40 14 77469 813 31619048
Nikolsky's sign 15.08 10.40 8 77475 186 31619675
Leucine aminopeptidase increased 15.05 10.40 3 77480 0 31619861
Internal limiting membrane peeling 15.05 10.40 3 77480 0 31619861
Persistent corneal epithelial defect 15.02 10.40 5 77478 33 31619828
Undifferentiated connective tissue disease 15.02 10.40 5 77478 33 31619828
Metastases to lung 14.96 10.40 50 77433 8372 31611489
Magnetic resonance imaging spinal abnormal 14.96 10.40 6 77477 71 31619790
Encephalopathy 14.93 10.40 36 77447 32438 31587423
Schizophrenia 14.92 10.40 4 77479 10826 31609035
Myelodysplastic syndrome 14.92 10.40 15 77468 19236 31600625
Application site hypersensitivity 14.81 10.40 7 77476 126 31619735
Bradycardia 14.72 10.40 104 77379 69223 31550638
Discoloured vomit 14.61 10.40 11 77472 478 31619383
Visual evoked potentials abnormal 14.59 10.40 6 77477 76 31619785
Renal tubular necrosis 14.54 10.40 73 77410 14686 31605175
Transplant rejection 14.53 10.40 3 77480 9705 31610156
Jaundice 14.52 10.40 125 77358 30162 31589699
Skin ulcer 14.47 10.40 91 77392 19894 31599967
Desmoid tumour 14.47 10.40 7 77476 133 31619728
Oral mucosa erosion 14.42 10.40 14 77469 863 31618998
Gastric disorder 14.30 10.40 61 77422 11467 31608394
Sedation 14.14 10.40 87 77396 18878 31600983
Rash erythematous 13.96 10.40 99 77384 22528 31597333
Energy increased 13.91 10.40 16 77467 1200 31618661
Chronic obstructive pulmonary disease 13.83 10.40 60 77423 45106 31574755
Pain in extremity 13.83 10.40 377 77106 115826 31504035
Anxiety 13.80 10.40 149 77334 90884 31528977
Retroperitoneal fibrosis 13.79 10.40 9 77474 310 31619551
Sciatic nerve palsy 13.68 10.40 5 77478 45 31619816
Tongue oedema 13.63 10.40 24 77459 2669 31617192
Microcephaly 13.58 10.40 13 77470 787 31619074
Costovertebral angle tenderness 13.56 10.40 6 77477 92 31619769
Deafness congenital 13.56 10.40 6 77477 92 31619769
Retinal toxicity 13.54 10.40 10 77473 422 31619439
Myelosuppression 13.54 10.40 10 77473 14910 31604951
Discomfort 13.46 10.40 77 77406 16279 31603582
Corneal opacity 13.45 10.40 11 77472 540 31619321
Xanthelasma 13.39 10.40 6 77477 95 31619766
Ductus arteriosus stenosis foetal 13.33 10.40 6 77477 96 31619765
Delirium 13.32 10.40 54 77429 41367 31578494
Oligohydramnios 13.32 10.40 9 77474 329 31619532
Intestinal metastasis 13.30 10.40 7 77476 160 31619701
Neisseria infection 13.29 10.40 4 77479 18 31619843
Platelet count decreased 13.26 10.40 190 77293 110245 31509616
Urinary tract infection 13.24 10.40 122 77361 76747 31543114
Shock symptom 13.22 10.40 6 77477 98 31619763
Bladder cancer 13.19 10.40 10 77473 14715 31605146
Duodenal obstruction 13.18 10.40 7 77476 163 31619698
Fixed eruption 13.17 10.40 17 77466 1436 31618425
Endoscopy abnormal 13.12 10.40 4 77479 19 31619842
Central nervous system inflammation 13.06 10.40 6 77477 101 31619760
Aggression 13.04 10.40 47 77436 37244 31582617
Megacolon 13.03 10.40 18 77465 1624 31618237
Lentigo maligna 13.01 10.40 9 77474 342 31619519
Peritonsillitis 12.98 10.40 3 77480 3 31619858
Rhabdomyolysis 12.96 10.40 223 77260 63358 31556503
Laryngeal oedema 12.96 10.40 26 77457 3191 31616670
Application site exfoliation 12.95 10.40 6 77477 103 31619758
Stomatitis 12.95 10.40 51 77432 39387 31580474
Oculomucocutaneous syndrome 12.92 10.40 7 77476 170 31619691
Dehydration 12.91 10.40 209 77274 118902 31500959
Drug reaction with eosinophilia and systemic symptoms 12.91 10.40 121 77362 29897 31589964
Thrombosis mesenteric vessel 12.87 10.40 5 77478 54 31619807
White blood cell count decreased 12.87 10.40 144 77339 87254 31532607
Ascites 12.86 10.40 54 77429 40959 31578902
Keratopathy 12.81 10.40 10 77473 459 31619402
Ventricular tachycardia 12.79 10.40 24 77459 23677 31596184
Spondyloarthropathy 12.76 10.40 11 77472 581 31619280
Skin erosion 12.75 10.40 19 77464 1837 31618024
Remission not achieved 12.75 10.40 6 77477 107 31619754
Hyperglycaemia 12.73 10.40 46 77437 36430 31583431
Gastric bypass 12.70 10.40 8 77475 259 31619602
Gout 12.69 10.40 82 77401 18092 31601769
Craniocerebral injury 12.65 10.40 24 77459 2826 31617035
Oligoarthritis 12.65 10.40 6 77477 109 31619752
Gouty arthritis 12.63 10.40 14 77469 1008 31618853
Diarrhoea 12.62 10.40 719 76764 351690 31268171
Pneumonitis 12.55 10.40 36 77447 30616 31589245
Hyperaesthesia 12.55 10.40 29 77454 3922 31615939
Inflammatory marker increased 12.54 10.40 30 77453 4148 31615713
Eye swelling 12.52 10.40 50 77433 9126 31610735
Tonsil cancer 12.51 10.40 14 77469 1019 31618842
Cold sweat 12.42 10.40 50 77433 9159 31610702
No adverse event 12.33 10.40 18 77465 19607 31600254
Prurigo 12.32 10.40 11 77472 609 31619252
Hepatic mass 12.24 10.40 14 77469 1043 31618818
Linear IgA disease 12.21 10.40 17 77466 1545 31618316
Double stranded DNA antibody positive 12.02 10.40 7 77476 196 31619665
Skin graft 12 10.40 10 77473 504 31619357
Tumour invasion 11.97 10.40 8 77475 287 31619574
Post infection glomerulonephritis 11.91 10.40 5 77478 67 31619794
Drug intolerance 11.90 10.40 186 77297 51847 31568014
Physical examination abnormal 11.88 10.40 8 77475 291 31619570
Musculoskeletal discomfort 11.86 10.40 41 77442 6982 31612879
Soft tissue infection 11.82 10.40 19 77464 1962 31617899
Hyperkalaemia 11.81 10.40 222 77261 64129 31555732
Dermatosis 11.78 10.40 8 77475 295 31619566
Unevaluable event 11.73 10.40 37 77446 30538 31589323
Neutrophil count decreased 11.69 10.40 66 77417 46328 31573533
Ocular hyperaemia 11.68 10.40 52 77431 9957 31609904
Intervertebral disc degeneration 11.66 10.40 35 77448 5536 31614325
Acquired haemophilia 11.59 10.40 13 77470 948 31618913
Skin necrosis 11.56 10.40 35 77448 5563 31614298
Myofascial pain syndrome 11.52 10.40 8 77475 306 31619555
Right ventricular failure 11.52 10.40 3 77480 8279 31611582
Eye pain 11.52 10.40 60 77423 12244 31607617
Intestinal transit time decreased 11.45 10.40 3 77480 7 31619854
Small intestine ulcer 11.36 10.40 9 77474 422 31619439
Metastases to heart 11.33 10.40 6 77477 139 31619722
Lipid metabolism disorder 11.29 10.40 8 77475 316 31619545
COVID-19 11.26 10.40 83 77400 54738 31565123
Skin lesion 11.22 10.40 84 77399 19443 31600418
Duodenitis 11.17 10.40 29 77454 4219 31615642
Pyoderma gangrenosum 11.17 10.40 15 77468 1317 31618544
Laboratory test abnormal 11.11 10.40 18 77465 18796 31601065
Ecthyma 11.11 10.40 9 77474 436 31619425
Post procedural infection 11.01 10.40 30 77453 4493 31615368
Terminal insomnia 11 10.40 9 77474 442 31619419
Ileal perforation 11.00 10.40 11 77472 703 31619158
Exposure to communicable disease 10.99 10.40 6 77477 148 31619713
Ulcer 10.98 10.40 43 77440 7778 31612083
Corneal infiltrates 10.88 10.40 6 77477 151 31619710
Orthostatic hypotension 10.88 10.40 27 77456 24092 31595769
Metatarsalgia 10.84 10.40 5 77478 85 31619776
Adverse event 10.82 10.40 15 77468 16690 31603171
Ejection fraction 10.79 10.40 5 77478 86 31619775
Saccadic eye movement 10.77 10.40 6 77477 154 31619707
Skull fractured base 10.77 10.40 6 77477 154 31619707
Hypertension 10.72 10.40 235 77248 127865 31491996
Postictal paralysis 10.71 10.40 7 77476 242 31619619
Duodenal ulcer repair 10.68 10.40 3 77480 10 31619851
Pancreatitis 10.66 10.40 48 77435 35723 31584138
Obstruction gastric 10.65 10.40 12 77471 880 31618981
Rash 10.64 10.40 598 76885 200888 31418973
Slow speech 10.62 10.40 13 77470 1041 31618820
Febrile bone marrow aplasia 10.62 10.40 3 77480 7843 31612018
Sudden cardiac death 10.61 10.40 25 77458 3424 31616437
Application site dermatitis 10.57 10.40 4 77479 40 31619821
Oral herpes 10.56 10.40 31 77452 4842 31615019
Brain natriuretic peptide increased 10.55 10.40 31 77452 4845 31615016
Small intestine carcinoma 10.55 10.40 10 77473 598 31619263
Burns second degree 10.46 10.40 8 77475 356 31619505
Axillary pain 10.46 10.40 8 77475 356 31619505

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
Pemphigus 1487.74 9.98 1655 252207 81381 70593201
Systemic lupus erythematosus 1330.01 9.98 1729 252133 100173 70574409
Glossodynia 1293.55 9.98 1571 252291 84916 70589666
Hand deformity 1266.02 9.98 1554 252308 84928 70589654
Pericarditis 1243.07 9.98 1524 252338 83181 70591401
Anti-cyclic citrullinated peptide antibody positive 1140.18 9.98 1330 252532 68855 70605727
Wound 1090.44 9.98 1545 252317 97187 70577395
Discomfort 1035.54 9.98 1561 252301 103875 70570707
Duodenal ulcer perforation 963.95 9.98 1047 252815 50065 70624517
Embolia cutis medicamentosa 936.32 9.98 245 253617 311 70674271
Arthropathy 888.18 9.98 1776 252086 148281 70526301
Synovitis 842.08 9.98 1593 252269 127635 70546947
Helicobacter infection 825.25 9.98 1007 252855 54649 70619933
Abdominal discomfort 807.80 9.98 2124 251738 212534 70462048
Swelling 771.85 9.98 1926 251936 186613 70487969
Alopecia 755.90 9.98 1973 251889 196517 70478065
Joint swelling 647.38 9.98 2185 251677 251026 70423556
Rheumatoid arthritis 621.61 9.98 2372 251490 289433 70385149
Death 604.62 9.98 562 253300 509499 70165083
Hepatic enzyme increased 604.03 9.98 1567 252295 155423 70519159
Hypersensitivity 578.38 9.98 1973 251889 227839 70446743
Contraindicated product administered 576.86 9.98 1400 252462 133212 70541370
Maternal exposure during pregnancy 556.83 9.98 1257 252605 114088 70560494
Blister 555.48 9.98 1157 252705 99369 70575213
Muscle injury 520.14 9.98 665 253197 37829 70636753
Rheumatoid factor positive 518.58 9.98 747 253115 47653 70626929
Drug intolerance 499.64 9.98 1858 252004 223829 70450753
Irritable bowel syndrome 490.44 9.98 747 253115 50103 70624479
Folliculitis 485.59 9.98 677 253185 41893 70632689
Infusion related reaction 458.84 9.98 1652 252210 195882 70478700
Sleep disorder due to general medical condition, insomnia type 437.34 9.98 588 253274 35144 70639438
Pain 403.27 9.98 3718 250144 625098 70049484
Therapeutic product effect decreased 395.22 9.98 1268 252594 141750 70532832
Febrile neutropenia 374.01 9.98 132 253730 204186 70470396
Impaired healing 344.86 9.98 798 253064 73576 70601006
Neutropenia 335.13 9.98 258 253604 256898 70417684
Gastrointestinal disorder 307.92 9.98 953 252909 104474 70570108
Musculoskeletal stiffness 273.72 9.98 1151 252711 146609 70527973
Toxicity to various agents 258.36 9.98 620 253242 381552 70293030
Rheumatic fever 252.66 9.98 314 253548 17346 70657236
Ankylosing spondylitis 248.62 9.98 255 253607 11391 70663191
Completed suicide 241.53 9.98 274 253588 226861 70447721
Pneumonia 236.32 9.98 1215 252647 595017 70079565
Arthralgia 234.62 9.98 2792 251070 500598 70173984
Melaena 233.55 9.98 579 253283 55776 70618806
Gastric ulcer 233.39 9.98 413 253449 31377 70643205
Off label use 222.44 9.98 1653 252209 741407 69933175
Hip arthroplasty 221.14 9.98 376 253486 27664 70646918
Swollen joint count increased 211.26 9.98 253 253609 13447 70661135
Thrombocytopenia 193.37 9.98 350 253512 238760 70435822
Treatment failure 193.05 9.98 1022 252840 143120 70531462
Product use issue 189.58 9.98 1197 252665 178740 70495842
Psoriatic arthropathy 186.72 9.98 583 253279 64188 70610394
Rash 185.26 9.98 2706 251156 507856 70166726
Hypotension 182.33 9.98 786 253076 403595 70270987
Cardiac failure congestive 176.19 9.98 136 253726 135321 70539261
Knee arthroplasty 175.66 9.98 383 253479 33918 70640664
Disease progression 175.36 9.98 181 253681 156491 70518091
Atrial fibrillation 173.42 9.98 244 253618 184104 70490478
Lower respiratory tract infection 165.54 9.98 816 253046 111097 70563485
Ill-defined disorder 165.48 9.98 501 253361 54240 70620342
Stomatitis 157.80 9.98 890 252972 127621 70546961
Duodenal ulcer 155.13 9.98 230 253632 15050 70659532
Plasma cell myeloma 152.67 9.98 37 253825 73164 70601418
Sepsis 151.74 9.98 414 253448 244131 70430451
Large intestinal stenosis 138.60 9.98 96 253766 2467 70672115
Gastric ulcer perforation 137.19 9.98 87 253775 1920 70672662
Blood cholesterol increased 136.08 9.98 524 253338 64080 70610502
Grip strength decreased 133.95 9.98 218 253644 15467 70659115
Pancytopenia 133.34 9.98 209 253653 150898 70523684
Cough 132.57 9.98 656 253206 324721 70349861
Diarrhoea 129.39 9.98 2000 251862 781341 69893241
Type 2 diabetes mellitus 126.31 9.98 396 253466 43684 70630898
Anaphylactic shock 124.37 9.98 324 253538 32166 70642416
Electrocardiogram QT prolonged 123.11 9.98 73 253789 83444 70591138
Intestinal diaphragm disease 121.01 9.98 46 253816 304 70674278
Osteoarthritis 118.55 9.98 553 253309 73594 70600988
Product dose omission issue 117.76 9.98 392 253470 217076 70457506
Pruritus 117.08 9.98 1811 252051 343749 70330833
Fibromyalgia 111.41 9.98 401 253461 47473 70627109
Large intestinal ulcer 109.73 9.98 105 253757 4307 70670275
Angioedema 109.60 9.98 501 253361 66109 70608473
Seizure 106.10 9.98 307 253555 177655 70496927
Contusion 105.35 9.98 802 253060 127234 70547348
Platelet count decreased 105.13 9.98 309 253553 177913 70496669
Constipation 101.02 9.98 512 253350 251926 70422656
Cerebrovascular accident 100.55 9.98 228 253634 143242 70531340
Gastritis erosive 95.44 9.98 147 253715 9948 70664634
Dehydration 94.31 9.98 452 253410 225690 70448892
Nasopharyngitis 94.27 9.98 1212 252650 220994 70453588
Hypokalaemia 93.14 9.98 207 253655 130981 70543601
Leukopenia 91.52 9.98 150 253712 106410 70568172
Cardiac arrest 91.47 9.98 281 253581 159553 70515029
Peripheral swelling 91.14 9.98 1268 252594 235295 70439287
Kounis syndrome 90.23 9.98 84 253778 3327 70671255
Anaphylactic reaction 86.60 9.98 511 253351 74463 70600119
White blood cell count decreased 86.49 9.98 315 253547 169826 70504756
Cardio-respiratory arrest 86.20 9.98 142 253720 100535 70574047
Sinusitis 85.85 9.98 955 252907 168240 70506342
Infection 83.69 9.98 1136 252726 209649 70464933
Hypoxia 81.47 9.98 130 253732 93214 70581368
Neutrophil count decreased 81.13 9.98 108 253754 83448 70591134
Deafness transitory 79.93 9.98 47 253815 901 70673681
Respiratory failure 79.58 9.98 322 253540 168413 70506169
Malignant neoplasm progression 79.32 9.98 201 253661 121538 70553044
Cytomegalovirus infection 79.26 9.98 22 253840 39736 70634846
Bradycardia 78.70 9.98 209 253653 124406 70550176
Hypoglycaemia 76.31 9.98 138 253724 94226 70580356
Liver injury 76.14 9.98 320 253542 40715 70633867
Fall 75.39 9.98 1127 252735 442969 70231613
Cardiac failure 74.11 9.98 264 253598 143277 70531305
Periorbital oedema 73.20 9.98 113 253749 7662 70666920
Nausea 70.34 9.98 2422 251440 849666 69824916
Neuropathy peripheral 69.85 9.98 227 253635 126669 70547913
Pulmonary embolism 69.44 9.98 304 253558 155563 70519019
Drug abuse 69.44 9.98 281 253581 146975 70527607
Anxiety 68.99 9.98 483 253379 219847 70454735
Sacroiliitis 68.65 9.98 71 253791 3202 70671380
Cognitive disorder 68.64 9.98 70 253792 60886 70613696
Joint dislocation 68.49 9.98 157 253705 14374 70660208
Hospitalisation 66.53 9.98 121 253741 82447 70592135
COVID-19 66.30 9.98 178 253684 105579 70569003
Mental status changes 66.03 9.98 77 253785 63024 70611558
Hypomagnesaemia 65.38 9.98 32 253830 40732 70633850
Myocardial infarction 63.14 9.98 358 253504 171287 70503295
Gastric ulcer haemorrhage 62.94 9.98 111 253751 8407 70666175
Pleural effusion 62.35 9.98 254 253608 132610 70541972
Injection site necrosis 62.22 9.98 46 253816 1313 70673269
Urinary tract infection 61.97 9.98 580 253282 248189 70426393
Type I hypersensitivity 60.98 9.98 71 253791 3661 70670921
Aspirin-exacerbated respiratory disease 59.88 9.98 43 253819 1172 70673410
Oxygen saturation decreased 59.52 9.98 215 253647 116214 70558368
Ascites 59.01 9.98 94 253768 67453 70607129
Ear infection 58.96 9.98 229 253633 28107 70646475
Pulmonary arterial hypertension 58.73 9.98 22 253840 32833 70641749
Neurotoxicity 58.53 9.98 17 253845 29809 70644773
Device expulsion 58.12 9.98 6 253856 22240 70652342
Abdominal pain upper 58.12 9.98 995 252867 192607 70481975
Cytokine release syndrome 57.95 9.98 12 253850 26455 70648127
Maternal exposure timing unspecified 57.93 9.98 75 253787 4316 70670266
General physical health deterioration 57.68 9.98 1175 252687 234856 70439726
Urticaria 57.59 9.98 861 253001 162188 70512394
Live birth 57.51 9.98 142 253720 13637 70660945
Neuroleptic malignant syndrome 56.51 9.98 12 253850 25995 70648587
Retinitis 56.37 9.98 72 253790 4088 70670494
Adverse event 55.75 9.98 335 253527 49126 70625456
Epistaxis 54.81 9.98 186 253676 102441 70572141
Gastrointestinal erosion 54.57 9.98 38 253824 985 70673597
Tachycardia 54.44 9.98 338 253524 158208 70516374
Acute myeloid leukaemia 53.20 9.98 22 253840 30918 70643664
Mucosal inflammation 51.54 9.98 103 253759 67747 70606835
Seronegative arthritis 51.43 9.98 62 253800 3317 70671265
Deep vein thrombosis 50.41 9.98 215 253647 110827 70563755
Spinal pain 50.33 9.98 135 253727 13635 70660947
Bacteraemia 50.14 9.98 21 253841 29288 70645294
Agitation 50.02 9.98 169 253693 93206 70581376
Neoplasm progression 49.72 9.98 53 253809 45175 70629407
Red blood cell sedimentation rate abnormal 48.43 9.98 6 253856 19297 70655285
Septic shock 48.15 9.98 222 253640 112036 70562546
Clostridium difficile infection 47.91 9.98 41 253821 38775 70635807
Posterior reversible encephalopathy syndrome 47.72 9.98 14 253848 24388 70650194
Fluid retention 47.48 9.98 97 253765 63288 70611294
Dislocation of vertebra 47.23 9.98 72 253790 4828 70669754
Blood glucose increased 46.99 9.98 199 253663 102783 70571799
Facet joint syndrome 46.91 9.98 81 253781 6032 70668550
Encephalopathy 46.50 9.98 94 253768 61567 70613015
Joint range of motion decreased 45.99 9.98 200 253662 25826 70648756
Gastric haemorrhage 45.87 9.98 133 253729 14052 70660530
Oligohydramnios 45.37 9.98 57 253805 3183 70671399
Anti-cyclic citrullinated peptide antibody 44.95 9.98 58 253804 3327 70671255
Adjustment disorder with depressed mood 44.94 9.98 65 253797 4158 70670424
Myelosuppression 44.91 9.98 26 253836 30119 70644463
Transplant rejection 44.74 9.98 6 253856 18165 70656417
Corneal epithelium defect 44.68 9.98 29 253833 667 70673915
Aggression 44.64 9.98 65 253797 48381 70626201
Balance disorder 44.38 9.98 169 253693 89959 70584623
Pancreatitis 44.36 9.98 99 253763 62569 70612013
Haematemesis 44.30 9.98 313 253549 48484 70626098
Hyperglycaemia 44.30 9.98 104 253758 64568 70610014
Hypervolaemia 44.24 9.98 46 253816 39660 70634922
Chronic obstructive pulmonary disease 44.04 9.98 137 253725 77504 70597078
Bone marrow failure 43.95 9.98 67 253795 48943 70625639
Injury 43.59 9.98 390 253472 64855 70609727
Anaemia 43.27 9.98 1106 252756 402317 70272265
Ventricular tachycardia 43.12 9.98 40 253822 36383 70638199
Asthenia 43.09 9.98 1278 252584 456388 70218194
Drug resistance 42.83 9.98 44 253818 38146 70636436
Diabetes mellitus 42.70 9.98 124 253738 71700 70602882
Schizophrenia 42.60 9.98 5 253857 16763 70657819
Small intestine ulcer 42.28 9.98 28 253834 667 70673915
Endoscopy abnormal 42.15 9.98 13 253849 40 70674542
Mobility decreased 42.02 9.98 558 253304 102441 70572141
Thrombotic microangiopathy 41.41 9.98 7 253855 17841 70656741
Spinal stenosis 41.38 9.98 131 253731 14522 70660060
Shoulder arthroplasty 41.23 9.98 52 253810 2915 70671667
Drug ineffective 40.66 9.98 3896 249966 935856 69738726
Fat necrosis 40.52 9.98 29 253833 786 70673796
Intestinal ulcer 40.43 9.98 40 253822 1710 70672872
Lip dry 39.95 9.98 100 253762 9685 70664897
Hypercalcaemia 39.26 9.98 39 253823 34346 70640236
Deep vein thrombosis postoperative 39.09 9.98 56 253806 3551 70671031
Respiratory distress 38.96 9.98 86 253776 54564 70620018
Ileal ulcer 38.67 9.98 31 253831 1000 70673582
Pericardial effusion 38.54 9.98 56 253806 41720 70632862
Tonsillar ulcer 38.11 9.98 22 253840 407 70674175
Ulcerative keratitis 38.05 9.98 53 253809 3274 70671308
Right ventricular failure 38.03 9.98 16 253846 22258 70652324
Upper gastrointestinal haemorrhage 37.96 9.98 247 253615 37230 70637352
Prescribed overdose 37.90 9.98 195 253667 26986 70647596
Tubulointerstitial nephritis 37.90 9.98 225 253637 32851 70641731
Haematotoxicity 37.57 9.98 3 253859 13671 70660911
Pneumonia aspiration 37.42 9.98 107 253755 62182 70612400
Hypoaesthesia 37.41 9.98 765 253097 152974 70521608
Ejection fraction decreased 37.35 9.98 33 253829 30729 70643853
Sleep disorder 37.06 9.98 398 253464 69474 70605108
Unevaluable event 37.05 9.98 82 253780 51981 70622601
Duodenal ulcer haemorrhage 36.67 9.98 77 253785 6641 70667941
Torsade de pointes 36.15 9.98 10 253852 18106 70656476
Functional gastrointestinal disorder 36.04 9.98 61 253801 4470 70670112
Gastrointestinal pain 36.01 9.98 87 253775 8240 70666342
Bronchopulmonary aspergillosis 36.00 9.98 15 253847 20987 70653595
Full blood count abnormal 35.81 9.98 41 253821 33837 70640745
Cytopenia 35.64 9.98 9 253853 17314 70657268
Orthostatic hypotension 35.60 9.98 83 253779 51660 70622922
Peptic ulcer 35.37 9.98 69 253793 5644 70668938
Laryngitis 35.02 9.98 118 253744 13513 70661069
Weight increased 34.83 9.98 1124 252738 241207 70433375
Porphyria acute 34.80 9.98 32 253830 1247 70673335
Mucosal erosion 34.56 9.98 40 253822 2049 70672533
Exposure during pregnancy 34.46 9.98 472 253390 87245 70587337
Multiple organ dysfunction syndrome 34.37 9.98 237 253625 108278 70566304
Hypocalcaemia 34.15 9.98 68 253794 44791 70629791
Application site rash 34.13 9.98 39 253823 1970 70672612
Keratopathy 33.92 9.98 28 253834 942 70673640
Wrong technique in product usage process 33.70 9.98 129 253733 68569 70606013
Analgesic drug level above therapeutic 33.53 9.98 21 253841 453 70674129
Neutropenic sepsis 33.46 9.98 24 253838 24806 70649776
Peritonitis 33.28 9.98 183 253679 25976 70648606
Hallucination 33.18 9.98 150 253712 76110 70598472
Dyspnoea exertional 33.10 9.98 156 253706 78274 70596308
Heart rate increased 33.04 9.98 233 253629 105915 70568667
Depression 32.97 9.98 507 253355 198467 70476115
Ligament calcification 32.90 9.98 16 253846 205 70674377
Large intestine perforation 32.82 9.98 113 253749 13082 70661500
Renal failure neonatal 32.68 9.98 12 253850 71 70674511
Ductus arteriosus stenosis foetal 32.68 9.98 12 253850 71 70674511
Status epilepticus 32.67 9.98 24 253838 24502 70650080
Progressive multifocal leukoencephalopathy 32.49 9.98 14 253848 19200 70655382
Febrile bone marrow aplasia 31.94 9.98 3 253859 11988 70662594
Aspergillus infection 31.88 9.98 12 253850 17856 70656726
Device related infection 31.85 9.98 41 253821 32144 70642438
Transfusion 31.42 9.98 14 253848 18822 70655760
Neck pain 31.41 9.98 371 253491 66286 70608296
Diabetic ketoacidosis 31.33 9.98 40 253822 31472 70643110
Inflammatory bowel disease 31.31 9.98 61 253801 4985 70669597
Cardiogenic shock 31.26 9.98 51 253811 36256 70638326
Enterococcal infection 31.13 9.98 7 253855 14575 70660007
Atelectasis 30.67 9.98 35 253827 28927 70645655
Lymphocyte count decreased 30.63 9.98 69 253793 43470 70631112
Pharyngitis 30.49 9.98 149 253713 20202 70654380
Dyspnoea 30.25 9.98 2360 251502 767700 69906882
Generalised tonic-clonic seizure 30.16 9.98 65 253797 41596 70632986
Bladder cancer 30.07 9.98 12 253850 17230 70657352
Incorrect dose administered 29.77 9.98 130 253732 66589 70607993
Sedation complication 29.52 9.98 6 253856 13404 70661178
Corneal thinning 29.45 9.98 14 253848 170 70674412
Cellulitis 29.42 9.98 220 253642 98708 70575874
Respiratory arrest 29.30 9.98 97 253765 53836 70620746
Coma 28.88 9.98 201 253661 91643 70582939
Lymphocyte stimulation test positive 28.78 9.98 27 253835 1080 70673502
Device dislocation 28.73 9.98 23 253839 22484 70652098
Application site eczema 28.70 9.98 7 253855 5 70674577
Gastrointestinal ulcer 28.62 9.98 45 253817 3100 70671482
Hyponatraemia 28.57 9.98 402 253460 159685 70514897
Syncope 28.56 9.98 419 253443 165290 70509292
Conjunctival hyperaemia 28.53 9.98 52 253810 4041 70670541
Pulmonary oedema 28.44 9.98 175 253687 82103 70592479
Exostosis 28.29 9.98 114 253748 14231 70660351
Obstructive airways disorder 28.26 9.98 31 253831 26082 70648500
Immune reconstitution inflammatory syndrome 28.21 9.98 6 253856 12984 70661598
Dry skin 28.10 9.98 104 253758 55827 70618755
Tenderness 28.08 9.98 150 253712 21060 70653522
Intestinal atony 27.98 9.98 9 253853 33 70674549
Psychotic disorder 27.98 9.98 58 253804 37643 70636939
Neonatal respiratory acidosis 27.84 9.98 10 253852 55 70674527
Hepatic failure 27.75 9.98 109 253753 57516 70617066
Infective pulmonary exacerbation of cystic fibrosis 27.70 9.98 5 253857 12153 70662429
Hypernatraemia 27.50 9.98 6 253856 12755 70661827
Synovial cyst 27.34 9.98 81 253781 8661 70665921
Foot deformity 27.29 9.98 146 253716 20509 70654073
Pneumocystis jirovecii pneumonia 27.09 9.98 41 253821 30041 70644541
Gastritis 27.00 9.98 261 253601 44330 70630252
Adverse drug reaction 26.97 9.98 301 253561 53043 70621539
Glomerulonephritis minimal lesion 26.96 9.98 22 253840 728 70673854
Soft tissue injury 26.87 9.98 32 253830 1690 70672892
Diabetes mellitus inadequate control 26.65 9.98 25 253837 22620 70651962
C-reactive protein increased 26.57 9.98 549 253313 109968 70564614
Dysphagia 26.40 9.98 267 253595 112567 70562015
Rotator cuff repair 26.29 9.98 31 253831 1620 70672962
Akathisia 26.05 9.98 6 253856 12287 70662295
Chest discomfort 26.03 9.98 302 253560 124079 70550503
Drug hypersensitivity 25.91 9.98 1168 252694 261291 70413291
Weight decreased 25.81 9.98 881 252981 309607 70364975
Lymphatic fistula 25.72 9.98 22 253840 778 70673804
Femoral hernia incarcerated 25.56 9.98 22 253840 785 70673797
Pregnancy 25.49 9.98 159 253703 23622 70650960
Mastoid abscess 25.40 9.98 6 253856 3 70674579
Bradycardia neonatal 25.35 9.98 10 253852 74 70674508
Urosepsis 25.29 9.98 29 253833 23920 70650662
Jejunal ulcer perforation 25.28 9.98 11 253851 107 70674475
Multiple sclerosis relapse 25.03 9.98 75 253787 42942 70631640
Metastases to stomach 24.99 9.98 14 253848 244 70674338
Tissue infiltration 24.98 9.98 20 253842 644 70673938
Inflammation 24.93 9.98 408 253454 78257 70596325
Lymphopenia 24.92 9.98 37 253825 27322 70647260
Iris hypopigmentation 24.69 9.98 9 253853 52 70674530
Second primary malignancy 24.60 9.98 8 253854 13043 70661539
Cardiac disorder 24.59 9.98 119 253743 59296 70615286
Cyanosis neonatal 24.55 9.98 9 253853 53 70674529
Device issue 24.40 9.98 30 253832 23995 70650587
Staphylococcal bacteraemia 24.31 9.98 5 253857 11077 70663505
Myocarditis 24.25 9.98 19 253843 18774 70655808
Necrotising fasciitis 24.18 9.98 58 253804 5468 70669114
Microcytic anaemia 23.97 9.98 53 253809 4736 70669846
Unresponsive to stimuli 23.90 9.98 100 253762 51831 70622751
Antidepressant drug level above therapeutic 23.83 9.98 19 253843 608 70673974
Frequent bowel movements 23.01 9.98 25 253837 21128 70653454
Paranoia 22.92 9.98 17 253845 17271 70657311
Palmar-plantar erythrodysaesthesia syndrome 22.90 9.98 46 253816 30201 70644381
Abnormal behaviour 22.83 9.98 57 253805 34652 70639930
Peripheral venous disease 22.75 9.98 87 253775 10600 70663982
Confusional state 22.74 9.98 1240 252622 283158 70391424
Suicidal ideation 22.53 9.98 151 253711 69445 70605137
Tongue oedema 22.51 9.98 61 253801 6198 70668384
Pulmonary hypertension 22.43 9.98 88 253774 46448 70628134
Dysarthria 22.34 9.98 131 253731 62182 70612400
Lupus-like syndrome 22.30 9.98 91 253771 11424 70663158
Premature delivery 22.28 9.98 26 253836 21278 70653304
Orbital oedema 22.27 9.98 14 253848 304 70674278
Extrapyramidal disorder 22.05 9.98 25 253837 20725 70653857
Blood pressure increased 22.03 9.98 510 253352 188007 70486575
Tubulointerstitial nephritis and uveitis syndrome 21.99 9.98 14 253848 311 70674271
Renal failure 21.96 9.98 512 253350 188558 70486024
Haemoptysis 21.91 9.98 102 253760 51350 70623232
Wrist deformity 21.80 9.98 30 253832 1832 70672750
Muscle swelling 21.70 9.98 20 253842 782 70673800
Arteriovenous fistula occlusion 21.65 9.98 17 253845 532 70674050
Acute graft versus host disease 21.64 9.98 4 253858 9558 70665024
Fatigue 21.57 9.98 3312 250550 821007 69853575
Failure to thrive 21.57 9.98 6 253856 10823 70663759
Anterior chamber cell 21.49 9.98 21 253841 884 70673698
Application site reaction 21.47 9.98 19 253843 704 70673878
Complication associated with device 21.42 9.98 15 253847 15698 70658884
Acute respiratory failure 21.34 9.98 109 253753 53556 70621026
Punctate keratitis 21.20 9.98 21 253841 899 70673683
Acute respiratory distress syndrome 21.19 9.98 76 253786 41178 70633404
Blood pressure fluctuation 21.19 9.98 124 253738 58888 70615694
Cerebral haemorrhage 21.08 9.98 110 253752 53754 70620828
Hepatic encephalopathy 21.05 9.98 29 253833 22089 70652493
Malignant mesenteric neoplasm 21.03 9.98 8 253854 53 70674529
Oesophageal carcinoma 21.02 9.98 4 253858 9362 70665220
Granulocytopenia 21.02 9.98 6 253856 10641 70663941
Cardiomyopathy 20.93 9.98 39 253823 26334 70648248
Renal cancer 20.91 9.98 8 253854 11788 70662794
Blue toe syndrome 20.75 9.98 17 253845 566 70674016
Flushing 20.68 9.98 191 253671 81981 70592601
Diffuse large B-cell lymphoma 20.50 9.98 11 253851 13291 70661291
Rheumatoid lung 20.48 9.98 41 253821 3418 70671164
Pancreatic steatosis 20.46 9.98 22 253840 1038 70673544
Haemorrhage intracranial 20.23 9.98 36 253826 24741 70649841
No adverse event 20.23 9.98 54 253808 32099 70642483
Throat irritation 20.22 9.98 62 253800 35242 70639340
Peripheral sensory neuropathy 20.20 9.98 9 253853 12101 70662481
Linear IgA disease 20.19 9.98 37 253825 2887 70671695
Respiratory tract congestion 20.18 9.98 20 253842 17633 70656949
Hypochromic anaemia 20.07 9.98 34 253828 2493 70672089
Upper respiratory tract infection 20.06 9.98 184 253678 79090 70595492
Blood calcium decreased 20.06 9.98 46 253816 28800 70645782
Acquired porphyria 20.04 9.98 7 253855 35 70674547
Hyperammonaemia 19.95 9.98 6 253856 10287 70664295
Lower respiratory tract infection viral 19.76 9.98 22 253840 1080 70673502
Abnormal loss of weight 19.66 9.98 67 253795 7717 70666865
Intentional product use issue 19.58 9.98 566 253296 119576 70555006
Candida infection 19.42 9.98 61 253801 34412 70640170
Tumour lysis syndrome 19.34 9.98 29 253833 21331 70653251
Adrenal insufficiency 19.34 9.98 38 253824 25157 70649425
Faeces discoloured 19.33 9.98 163 253699 26646 70647936
Stress 19.33 9.98 153 253709 67813 70606769
Blood potassium decreased 19.32 9.98 82 253780 42339 70632243
International normalised ratio increased 19.31 9.98 190 253672 80536 70594046
Sopor 19.30 9.98 53 253809 31214 70643368
Jejunal ulcer 19.17 9.98 11 253851 201 70674381
Lip ulceration 19.17 9.98 30 253832 2058 70672524
Gastrointestinal haemorrhage 19.12 9.98 635 253227 136773 70537809
Gallbladder adenocarcinoma 19.03 9.98 9 253853 108 70674474
Laboratory test abnormal 18.93 9.98 40 253822 25783 70648799
Productive cough 18.90 9.98 184 253678 78153 70596429
Hepatotoxicity 18.84 9.98 87 253775 43899 70630683
Product administered at inappropriate site 18.78 9.98 39 253823 3337 70671245
Application site erythema 18.75 9.98 48 253814 4713 70669869
Depressed mood 18.58 9.98 87 253775 43733 70630849
Erosive duodenitis 18.57 9.98 27 253835 1735 70672847
Immunosuppressant drug level increased 18.57 9.98 3 253859 7904 70666678
Aplasia cutis congenita 18.55 9.98 4 253858 0 70674582
Urine porphobilinogen increased 18.55 9.98 4 253858 0 70674582
Application site ulcer 18.53 9.98 9 253853 115 70674467
Soft tissue infection 18.53 9.98 40 253822 3517 70671065
Overdose 18.52 9.98 464 253398 169281 70505301
Electrocardiogram QRS complex prolonged 18.50 9.98 6 253856 9800 70664782
Anuria 18.38 9.98 127 253735 19526 70655056
Eschar 18.37 9.98 22 253840 1169 70673413
Feeding disorder 18.30 9.98 101 253761 14355 70660227
Injection site bruising 18.27 9.98 72 253790 37960 70636622
Vaccination site reaction 18.19 9.98 9 253853 120 70674462
Blood glucose decreased 18.07 9.98 37 253825 24122 70650460
Intestinal congestion 18.07 9.98 5 253857 9 70674573
Lethargy 18.04 9.98 177 253685 75073 70599509
Hypoproteinaemia 18.01 9.98 40 253822 3586 70670996
Muscle tone disorder 18.00 9.98 9 253853 123 70674459
Product quality issue 17.99 9.98 53 253809 30508 70644074
Pyloric stenosis 17.97 9.98 14 253848 433 70674149
Hypoaldosteronism 17.96 9.98 13 253849 359 70674223
Body mass index abnormal 17.91 9.98 11 253851 229 70674353
Onychomadesis 17.90 9.98 43 253819 4058 70670524
Ataxia 17.84 9.98 35 253827 23182 70651400
Subdural haematoma 17.84 9.98 50 253812 29248 70645334
Viral upper respiratory tract infection 17.74 9.98 69 253793 8473 70666109
Angiocardiogram 17.74 9.98 11 253851 233 70674349
Complications of intestinal transplant 17.72 9.98 5 253857 10 70674572
Drug tolerance decreased 17.71 9.98 76 253786 9757 70664825
Tongue disorder 17.54 9.98 13 253849 13214 70661368
Spinal fusion surgery 17.54 9.98 42 253820 3955 70670627
Pulseless electrical activity 17.51 9.98 13 253849 13202 70661380
Coronary artery disease 17.49 9.98 142 253720 62594 70611988
Nephrotic syndrome 17.47 9.98 80 253782 10560 70664022
Atrioventricular block 17.44 9.98 12 253850 12676 70661906
Neonatal respiratory distress syndrome 17.41 9.98 11 253851 241 70674341
Haemophagocytic lymphohistiocytosis 17.40 9.98 27 253835 19585 70654997
Injection site hyperaesthesia 17.38 9.98 7 253855 55 70674527
Basal cell carcinoma 17.36 9.98 62 253800 33636 70640946
Creutzfeldt-Jakob disease 17.32 9.98 10 253852 185 70674397
Myelodysplastic syndrome 17.28 9.98 52 253810 29733 70644849
Drug level decreased 17.28 9.98 12 253850 12612 70661970
Foot operation 17.13 9.98 47 253815 4810 70669772
Hypogammaglobulinaemia 17.12 9.98 10 253852 11528 70663054
Drug dependence 17.09 9.98 72 253790 37249 70637333
Abdominal rebound tenderness 17.06 9.98 7 253855 58 70674524
Psychomotor hyperactivity 17.06 9.98 18 253844 15415 70659167
Bacterial infection 17.04 9.98 44 253818 26448 70648134
Epilepsy 17.04 9.98 76 253786 38708 70635874
Dementia 16.94 9.98 34 253828 22331 70652251
Disease recurrence 16.94 9.98 73 253789 37530 70637052
Sinus disorder 16.92 9.98 26 253836 18933 70655649
Fibrosis 16.91 9.98 47 253815 4847 70669735
Aplasia pure red cell 16.87 9.98 3 253859 7371 70667211
Neutrophil count increased 16.86 9.98 45 253817 26750 70647832
Vascular device infection 16.85 9.98 4 253858 8026 70666556
Salivary hypersecretion 16.76 9.98 13 253849 12912 70661670
Immunodeficiency 16.72 9.98 23 253839 17532 70657050
Ventricular fibrillation 16.70 9.98 46 253816 27065 70647517
Asthma 16.69 9.98 318 253544 120475 70554107
Blood pressure measurement 16.69 9.98 13 253849 402 70674180
Peritonitis bacterial 16.67 9.98 6 253856 9178 70665404
Sebaceous gland infection 16.63 9.98 9 253853 146 70674436
Small intestine carcinoma 16.61 9.98 19 253843 961 70673621
Nerve stimulation test abnormal 16.56 9.98 5 253857 14 70674568
Clostridium difficile colitis 16.55 9.98 51 253811 28945 70645637
Porphyria 16.55 9.98 10 253852 202 70674380
Application site swelling 16.52 9.98 16 253846 666 70673916
Movement disorder 16.51 9.98 145 253717 23984 70650598
Sciatic nerve injury 16.49 9.98 14 253848 490 70674092
Aplasia 16.48 9.98 3 253859 7248 70667334
Face oedema 16.48 9.98 152 253710 25487 70649095
Bronchitis 16.40 9.98 308 253554 116935 70557647
Mesenteric neoplasm 16.37 9.98 7 253855 65 70674517
Blood lactate dehydrogenase increased 16.32 9.98 195 253667 34932 70639650
Erythematotelangiectatic rosacea 16.30 9.98 5 253857 15 70674567
Oral pruritus 16.29 9.98 27 253835 1944 70672638
Jaundice 16.29 9.98 261 253601 49847 70624735
Autoimmune disorder 16.27 9.98 68 253794 8628 70665954
Emotional distress 16.26 9.98 73 253789 37115 70637467
Panniculitis 16.20 9.98 9 253853 10667 70663915
Postictal paralysis 16.16 9.98 12 253850 345 70674237
Blood test abnormal 16.14 9.98 17 253845 14573 70660009
Unintentional medical device removal 16.08 9.98 3 253859 7121 70667461
Cushingoid 16.06 9.98 5 253857 8383 70666199
Acute myocardial infarction 16.02 9.98 175 253687 72712 70601870
Undifferentiated connective tissue disease 16.00 9.98 6 253856 38 70674544
Libido increased 15.99 9.98 26 253836 1843 70672739
Full blood count decreased 15.95 9.98 39 253823 23879 70650703
Influenza like illness 15.95 9.98 153 253709 65178 70609404
Mania 15.86 9.98 23 253839 17151 70657431
Insomnia 15.84 9.98 628 253234 217178 70457404
Colitis erosive 15.83 9.98 8 253854 112 70674470
Small intestinal obstruction 15.82 9.98 41 253821 24614 70649968
Musculoskeletal disorder 15.79 9.98 124 253738 19847 70654735
Haematocrit decreased 15.78 9.98 130 253732 57128 70617454
Chills 15.73 9.98 396 253466 144390 70530192
Renal tubular necrosis 15.73 9.98 139 253723 23032 70651550
Hyperventilation 15.71 9.98 59 253803 7127 70667455
Injection site erythema 15.67 9.98 176 253686 72748 70601834
Spondyloarthropathy 15.63 9.98 18 253844 917 70673665
Bursitis 15.59 9.98 155 253707 26518 70648064
Troponin increased 15.59 9.98 22 253840 16592 70657990
Partial seizures 15.52 9.98 5 253857 8200 70666382
Pneumonitis 15.48 9.98 123 253739 54474 70620108
Iron deficiency anaemia 15.45 9.98 138 253724 22934 70651648
Cardiac massage 15.41 9.98 5 253857 19 70674563
Therapy cessation 15.40 9.98 65 253797 33611 70640971
Device leakage 15.40 9.98 7 253855 9301 70665281
Eastern Cooperative Oncology Group performance status 15.37 9.98 6 253856 43 70674539
Drug use disorder 15.36 9.98 5 253857 8146 70666436
Intestinal obstruction 15.35 9.98 79 253783 38746 70635836
Osteonecrosis of jaw 15.34 9.98 85 253777 40917 70633665
Atrial flutter 15.31 9.98 31 253831 20296 70654286
COVID-19 pneumonia 15.30 9.98 35 253827 21934 70652648
Myoclonus 15.30 9.98 46 253816 26309 70648273
Fixed eruption 15.28 9.98 30 253832 2466 70672116
Hepatitis C 15.24 9.98 14 253848 12793 70661789
Sciatic nerve palsy 15.18 9.98 7 253855 79 70674503
Application site oedema 15.18 9.98 7 253855 79 70674503
Pseudomonas infection 15.15 9.98 28 253834 18966 70655616
Omental necrosis 15.14 9.98 6 253856 45 70674537
Head titubation 15.13 9.98 17 253845 843 70673739
Depressed level of consciousness 15.08 9.98 221 253641 87210 70587372
Papulopustular rosacea 15.01 9.98 5 253857 21 70674561
Platelet dysfunction 15.00 9.98 12 253850 386 70674196
Vaginal ulceration 14.96 9.98 10 253852 242 70674340
Cystitis haemorrhagic 14.95 9.98 6 253856 8587 70665995
Fungal infection 14.95 9.98 76 253786 37391 70637191
Injection site pain 14.94 9.98 314 253548 117305 70557277
Wound infection pseudomonas 14.88 9.98 23 253839 1561 70673021
Abdominal tenderness 14.86 9.98 72 253790 9728 70664854
Application site injury 14.83 9.98 5 253857 22 70674560
Oculomucocutaneous syndrome 14.82 9.98 11 253851 316 70674266
Multiple-drug resistance 14.79 9.98 4 253858 7351 70667231
Injection site ulcer 14.70 9.98 15 253847 666 70673916
Sexual dysfunction 14.69 9.98 3 253859 6678 70667904
Pneumonia bacterial 14.68 9.98 23 253839 16618 70657964
Sinus bradycardia 14.62 9.98 40 253822 23583 70650999
Walking aid user 14.61 9.98 62 253800 7919 70666663
Nodule 14.58 9.98 31 253831 19938 70654644
Blood calcium increased 14.51 9.98 7 253855 8986 70665596
Cholestasis 14.45 9.98 106 253756 47766 70626816
Urine abnormality 14.43 9.98 5 253857 7833 70666749
Aphasia 14.42 9.98 93 253769 43156 70631426
Ventricular arrhythmia 14.41 9.98 5 253857 7825 70666757
Iris transillumination defect 14.40 9.98 8 253854 137 70674445
Ischaemic stroke 14.40 9.98 59 253803 30761 70643821
Haemoglobin decreased 14.39 9.98 594 253268 204565 70470017
Diverticulum intestinal 14.37 9.98 62 253800 7979 70666603
Central nervous system lesion 14.36 9.98 14 253848 12439 70662143
Central pain syndrome 14.35 9.98 11 253851 332 70674250
Skin toxicity 14.31 9.98 4 253858 7194 70667388
Breast cancer female 14.31 9.98 10 253852 10476 70664106
Meralgia paraesthetica 14.28 9.98 12 253850 414 70674168
Sleep disorder due to a general medical condition 14.28 9.98 10 253852 10466 70664116
Gastritis haemorrhagic 14.26 9.98 29 253833 2445 70672137
Transaminases increased 14.24 9.98 104 253758 46914 70627668
Terminal insomnia 14.23 9.98 18 253844 1012 70673570
Arthritis 14.19 9.98 455 253407 97525 70577057
Lip scab 14.18 9.98 4 253858 8 70674574
Tardive dyskinesia 14.18 9.98 9 253853 9920 70664662
Factor VIII deficiency 14.15 9.98 8 253854 142 70674440
Aspiration 14.15 9.98 26 253836 17649 70656933
Cardiomegaly 14.13 9.98 43 253819 24502 70650080
Treatment noncompliance 14.12 9.98 103 253759 46471 70628111
Red blood cell count decreased 14.11 9.98 119 253743 52042 70622540
Lip oedema 14.05 9.98 48 253814 5535 70669047
Pulmonary mass 14.02 9.98 47 253815 25986 70648596
Oral pain 13.98 9.98 55 253807 29011 70645571
Inflammatory pain 13.98 9.98 17 253845 918 70673664
Pulmonary haemorrhage 13.97 9.98 17 253845 13656 70660926
Thrombosis 13.93 9.98 188 253674 75217 70599365
Internal limiting membrane peeling 13.91 9.98 3 253859 0 70674582
Respiratory syncytial virus infection 13.89 9.98 5 253857 7650 70666932
Hypermobility syndrome 13.88 9.98 13 253849 519 70674063
Fear 13.82 9.98 34 253828 20777 70653805
Discoloured vomit 13.81 9.98 20 253842 1281 70673301
Respiratory acidosis 13.77 9.98 10 253852 10271 70664311
Spondylitis 13.77 9.98 35 253827 3422 70671160
Encephalitis 13.76 9.98 17 253845 13568 70661014
Basal ganglion degeneration 13.76 9.98 12 253850 436 70674146
Bone marrow oedema 13.71 9.98 21 253841 1414 70673168
Porphyrins urine increased 13.70 9.98 5 253857 29 70674553
Post-traumatic neck syndrome 13.67 9.98 25 253837 1948 70672634
Gastrointestinal mucosal exfoliation 13.60 9.98 9 253853 214 70674368
Eyelid oedema 13.58 9.98 85 253777 12642 70661940
Pyoderma streptococcal 13.57 9.98 4 253858 10 70674572
Staphylococcal infection 13.49 9.98 124 253738 53280 70621302
Seroma 13.49 9.98 26 253836 2108 70672474
Nail operation 13.49 9.98 13 253849 538 70674044
Arrhythmia 13.48 9.98 132 253730 56011 70618571
Acquired haemophilia 13.46 9.98 24 253838 1833 70672749
Alanine aminotransferase abnormal 13.42 9.98 6 253856 8053 70666529
Breast cancer metastatic 13.42 9.98 10 253852 10136 70664446
Atrioventricular block complete 13.33 9.98 21 253841 15142 70659440
Device occlusion 13.31 9.98 11 253851 10584 70663998
Heart rate irregular 13.24 9.98 58 253804 29685 70644897
Parotid gland enlargement 13.21 9.98 16 253846 860 70673722
Hiccups 13.21 9.98 8 253854 9044 70665538
Vasoconstriction 13.21 9.98 14 253848 650 70673932
Gynaecomastia 13.19 9.98 4 253858 6819 70667763
Intestinal metaplasia 13.16 9.98 5 253857 33 70674549
Peptic ulcer haemorrhage 13.16 9.98 16 253846 864 70673718
Small intestinal ulcer haemorrhage 13.13 9.98 7 253855 110 70674472
Respiratory disorder 13.11 9.98 84 253778 39039 70635543
Palatal oedema 13.09 9.98 19 253843 1219 70673363
Haemorrhage 13.05 9.98 216 253646 83599 70590983
Meteoropathy 13.04 9.98 4 253858 12 70674570
Oral mucosa erosion 13.04 9.98 23 253839 1742 70672840
Intervertebral disc disorder 12.95 9.98 41 253821 4544 70670038
Influenza 12.89 9.98 309 253553 113391 70561191
Acquired diaphragmatic eventration 12.81 9.98 13 253849 573 70674009
Intestinal haemorrhage 12.81 9.98 49 253813 5971 70668611
C-reactive protein 12.76 9.98 25 253837 2051 70672531
Gastric mucosal lesion 12.68 9.98 16 253846 897 70673685
Platelet function test abnormal 12.68 9.98 8 253854 175 70674407
Hypothermia 12.65 9.98 35 253827 20559 70654023
Aortic stenosis 12.57 9.98 4 253858 6612 70667970
Condition aggravated 12.54 9.98 1730 252132 425905 70248677
Tarsal tunnel syndrome 12.52 9.98 12 253850 493 70674089
Atrioventricular block first degree 12.47 9.98 14 253848 11659 70662923
Injection site haemorrhage 12.47 9.98 48 253814 25479 70649103
Pulmonary thrombosis 12.47 9.98 13 253849 11195 70663387
Secondary amyloidosis 12.44 9.98 8 253854 181 70674401
Arterial haemorrhage 12.43 9.98 27 253835 2384 70672198
Blood triglycerides increased 12.39 9.98 33 253829 19631 70654951
Duodenal stenosis 12.38 9.98 14 253848 699 70673883
Hypertensive crisis 12.38 9.98 32 253830 19230 70655352
Hepatic cytolysis 12.25 9.98 32 253830 19160 70655422
Alpha tumour necrosis factor increased 12.23 9.98 5 253857 41 70674541
Coronary arterial stent insertion 12.22 9.98 3 253859 5884 70668698
Pneumatosis intestinalis 12.22 9.98 3 253859 5884 70668698
Pyrexia 12.22 9.98 1947 251915 605005 70069577
Injection site abscess 12.21 9.98 20 253842 1426 70673156
Electrolyte imbalance 12.19 9.98 52 253810 26809 70647773
Oligoarthritis 12.13 9.98 12 253850 513 70674069
Intentional product misuse 12.11 9.98 206 253656 79389 70595193
Application site pain 12.11 9.98 39 253823 4363 70670219
Erythema multiforme 12.10 9.98 101 253761 16463 70658119
Underdose 12.07 9.98 59 253803 29324 70645258
Multiple sclerosis 12.06 9.98 48 253814 25237 70649345
Mood swings 12.05 9.98 30 253832 18256 70656326
Arteriosclerosis coronary artery 11.98 9.98 25 253837 16190 70658392
Breath sounds abnormal 11.95 9.98 18 253844 13213 70661369
Haemorrhoids 11.94 9.98 49 253813 25539 70649043
Porphyrins stool increased 11.93 9.98 5 253857 44 70674538
Leucine aminopeptidase increased 11.84 9.98 3 253859 3 70674579
Upper limb fracture 11.79 9.98 25 253837 16094 70658488
Corneal opacity 11.71 9.98 16 253846 970 70673612
Neoplasm malignant 11.69 9.98 58 253804 28716 70645866
Fistula 11.68 9.98 13 253849 10868 70663714
Vascular malformation 11.66 9.98 10 253852 355 70674227
Carbohydrate antigen 15-3 11.62 9.98 6 253856 88 70674494
Hyperlipidaemia 11.58 9.98 45 253817 23818 70650764
Renal impairment 11.57 9.98 410 253452 143527 70531055
Pulmonary alveolar haemorrhage 11.57 9.98 12 253850 10357 70664225
Oesophageal carcinoma recurrent 11.55 9.98 5 253857 48 70674534
Hemiplegia 11.52 9.98 20 253842 13875 70660707
Jejunal stenosis 11.50 9.98 6 253856 90 70674492
Abdominal lymphadenopathy 11.49 9.98 18 253844 1236 70673346
Dyspnoea at rest 11.48 9.98 5 253857 6814 70667768
Anal fissure 11.44 9.98 4 253858 6229 70668353
Pulmonary function test decreased 11.43 9.98 5 253857 6796 70667786
Application site exfoliation 11.40 9.98 10 253852 366 70674216
Carcinoembryonic antigen 11.39 9.98 6 253856 92 70674490
Toxic epidermal necrolysis 11.38 9.98 202 253660 39355 70635227
Atrioventricular block second degree 11.36 9.98 5 253857 6773 70667809
Laryngeal discomfort 11.36 9.98 12 253850 555 70674027
Pallor 11.35 9.98 208 253654 40766 70633816
Respiratory tract infection 11.35 9.98 97 253765 42301 70632281
Angina unstable 11.33 9.98 25 253837 15868 70658714
Exposure to toxic agent 11.32 9.98 4 253858 6190 70668392
Disability 11.29 9.98 92 253770 14891 70659691
Herpes zoster 11.28 9.98 226 253636 85009 70589573
Embolic stroke 11.27 9.98 6 253856 7283 70667299
Lentigo maligna 11.22 9.98 11 253851 465 70674117
Inflammatory marker increased 11.21 9.98 64 253798 9210 70665372
Persistent corneal epithelial defect 11.20 9.98 5 253857 52 70674530
Acute lymphocytic leukaemia 11.18 9.98 3 253859 5542 70669040
Haemolysis 11.14 9.98 15 253847 11536 70663046
Accidental exposure to product 11.14 9.98 57 253805 27994 70646588
Vomiting 11.13 9.98 1910 251952 591201 70083381
Multiple allergies 11.13 9.98 7 253855 7753 70666829
Glycosylated haemoglobin increased 11.10 9.98 29 253833 17362 70657220
Chest pain 11.10 9.98 762 253100 250498 70424084
Analgesic drug level increased 11.08 9.98 26 253836 2417 70672165
Gallbladder oedema 11.08 9.98 9 253853 296 70674286
Prurigo 11.08 9.98 18 253844 1275 70673307
Tremor 11.03 9.98 450 253412 155174 70519408
Rhinorrhoea 11.02 9.98 169 253693 66202 70608380
Mallory-Weiss syndrome 10.99 9.98 27 253835 2584 70671998
Axial spondyloarthritis 10.99 9.98 11 253851 477 70674105
Sinus node dysfunction 10.94 9.98 6 253856 7163 70667419
Epstein-Barr virus infection 10.94 9.98 19 253843 13179 70661403
Laparotomy 10.85 9.98 10 253852 391 70674191
Drooling 10.85 9.98 3 253859 5433 70669149
Squamous cell carcinoma of skin 10.81 9.98 18 253844 12694 70661888
Breast cancer stage III 10.80 9.98 50 253812 6631 70667951
HLA-B*27 positive 10.79 9.98 6 253856 103 70674479
Skin graft 10.77 9.98 15 253847 926 70673656
Euglycaemic diabetic ketoacidosis 10.77 9.98 4 253858 6003 70668579
Lividity 10.76 9.98 10 253852 395 70674187
Taste disorder 10.76 9.98 15 253847 11370 70663212
Gestational diabetes 10.76 9.98 4 253858 5997 70668585
Creatinine renal clearance decreased 10.73 9.98 29 253833 17171 70657411
Blood glucose abnormal 10.73 9.98 11 253851 9546 70665036
Heavy menstrual bleeding 10.71 9.98 18 253844 12647 70661935
Angina pectoris 10.70 9.98 116 253746 48267 70626315
Duodenal perforation 10.69 9.98 23 253839 2017 70672565
Hypertension 10.68 9.98 913 252949 295120 70379462
Onychomycosis 10.68 9.98 51 253811 6850 70667732
Therapy interrupted 10.66 9.98 49 253813 24753 70649829
Heparin-induced thrombocytopenia 10.61 9.98 10 253852 9027 70665555
Metastases to liver 10.61 9.98 52 253810 25826 70648756
Hepatitis B reactivation 10.60 9.98 3 253859 5352 70669230
Pancreatitis acute 10.58 9.98 107 253755 45117 70629465
Systemic candida 10.56 9.98 4 253858 5930 70668652
Injection site swelling 10.56 9.98 101 253761 43056 70631526
Anorgasmia 10.54 9.98 16 253846 1069 70673513
Wound necrosis 10.54 9.98 12 253850 604 70673978
Complication of device insertion 10.53 9.98 3 253859 5329 70669253
Paranasal cyst 10.49 9.98 10 253852 408 70674174
Emphysema 10.49 9.98 24 253838 15036 70659546
Metastases to central nervous system 10.43 9.98 24 253838 15010 70659572
Loss of personal independence in daily activities 10.40 9.98 228 253634 84682 70589900
Colorectal cancer 10.39 9.98 9 253853 8461 70666121
Dactylitis 10.38 9.98 24 253838 2209 70672373
Obstruction gastric 10.35 9.98 19 253843 1485 70673097
Intestinal ischaemia 10.33 9.98 17 253845 12047 70662535
Coagulopathy 10.33 9.98 73 253789 33176 70641406
Mast cell activation syndrome 10.33 9.98 12 253850 617 70673965
Supraventricular tachycardia 10.33 9.98 36 253826 19674 70654908
Dystonia 10.32 9.98 36 253826 19670 70654912
X-ray abnormal 10.28 9.98 26 253836 2534 70672048
Sciatica 10.28 9.98 134 253728 24493 70650089
Hostility 10.23 9.98 24 253838 2231 70672351
Somnolence 10.17 9.98 650 253212 214956 70459626
Episcleritis 10.14 9.98 15 253847 979 70673603
Extradural abscess 10.12 9.98 17 253845 1238 70673344
Respiratory depression 10.12 9.98 50 253812 24781 70649801
Neuropathic ulcer 10.09 9.98 5 253857 67 70674515
Malnutrition 10.06 9.98 38 253824 20279 70654303
Procedural pain 10.05 9.98 32 253830 17977 70656605
Liver function test abnormal 10.05 9.98 156 253706 60990 70613592
Delusion 10.05 9.98 35 253827 19130 70655452
Upper-airway cough syndrome 10.04 9.98 12 253850 9719 70664863
Hypermetropia 10.04 9.98 10 253852 431 70674151
Brain injury 10.02 9.98 14 253848 10603 70663979
Ciliary hyperaemia 10.02 9.98 5 253857 68 70674514
Application site dryness 10.00 9.98 7 253855 183 70674399
pH body fluid decreased 9.98 9.98 4 253858 31 70674551
Nasal congestion 9.98 9.98 170 253692 65502 70609080

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Right ventricular hypertrophy 36.53 33.34 8 116 15 89653

Pharmacologic Action:

SourceCodeDescription
ATC D11AX18 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC M01AB05 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M01AB55 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Acetic acid derivatives and related substances
ATC M02AA15 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 S01BC03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS
Antiinflammatory agents, non-steroids
ATC S01CC01 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
Antiinflammatory agents, non-steroids and antiinfectives in combination
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
FDA PE N0000008836 Decreased Prostaglandin Production
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
MeSH PA D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35544 cyclooxygenase inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug

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

DiseaseRelationSNOMED_IDDOID
Ankylosing spondylitis indication 9631008 DOID:7147
Pain indication 22253000
Tenosynovitis indication 67801009 DOID:970
Rheumatoid arthritis indication 69896004 DOID:7148
Actinic keratosis indication 201101007 DOID:8866
Dysmenorrhea indication 266599000
Lumbago indication 279039007
Osteoarthritis indication 396275006
Adhesive capsulitis of shoulder indication 399114005 DOID:14188
Analgesia in various types of cancer indication
Osteoarthritis in Patients at High Ulcer Risk indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Post-Op Photophobia indication
Postoperative Ocular Pain indication
Sprains and Strains indication
Osteoarthrosis of the Knee indication
Post-Op Ocular Inflammation indication
Renal colic off-label use 7093002
Tendinitis off-label use 34840004 DOID:971
Bursitis off-label use 84017003 DOID:2965
Cystoid macular edema off-label use 193387007 DOID:4447
Prevention of Ocular Surgery-Induced Miosis off-label use
Keratitis contraindication 5888003 DOID:4677
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Asthenia contraindication 13791008
Infection of skin AND/OR subcutaneous tissue contraindication 19824006
Myocardial infarction contraindication 22298006 DOID:5844
Inflammatory bowel disease contraindication 24526004 DOID:0050589
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Gastrointestinal ulcer contraindication 40845000
Body fluid retention contraindication 43498006
Skin ulcer contraindication 46742003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Corneal erosion contraindication 50792001
Duodenal ulcer disease contraindication 51868009 DOID:1724
Gastrointestinal perforation contraindication 51875005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Perforation of cornea contraindication 74895004
Corneal ulcer contraindication 91514001 DOID:8463
Corneal degeneration contraindication 111521006 DOID:1237
Open wound contraindication 125643001
Liver function tests abnormal contraindication 166603001
Asthma contraindication 195967001 DOID:2841
Deliveries by cesarean contraindication 200144004
Cerebrovascular accident contraindication 230690007
Coronary artery bypass graft contraindication 232717009
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Edema contraindication 267038008
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thromboembolic disorder contraindication 371039008
Cardiovascular event risk contraindication 395112001
Smokes tobacco daily contraindication 449868002
Gynecological Surgery contraindication
Uterine Rupture in Pregnancy contraindication
Bloody Vomit contraindication
Corneal Infiltrates contraindication




🐶 Veterinary Drug Use

SpeciesUseRelation
Horses Pain and inflammation associated with osteoarthritis Indication

🐶 Veterinary products

ProductApplicantIngredients
Surpass Topical Anti-Inflammatory Cream Boehringer lngelheim Animal Health USA Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.22 acidic
pKa2 0.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 7759394 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8097651 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
50MG CAMBIA ASSERTIO N022165 June 17, 2009 RX FOR SOLUTION ORAL 8927604 June 16, 2026 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** DYLOJECT JAVELIN PHARMS INC N022396 Dec. 23, 2014 DISCN SOLUTION INTRAVENOUS 8946292 March 22, 2027 MANAGEMENT OF PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8563613 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8871809 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9066913 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9101591 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9132110 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9168305 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9220784 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339551 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9339552 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9539335 Oct. 17, 2027 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8252838 April 21, 2028 USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7662858 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7884095 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 7939518 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8110606 Feb. 24, 2029 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 8623920 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL 9561200 Feb. 24, 2029 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8217078 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8618164 July 10, 2029 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION ON THE SAME KNEE
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8741956 July 10, 2029 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9370501 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9375412 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 9415029 July 10, 2029 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
18MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** PENNSAID NUVO PHARMS INC N020947 Nov. 4, 2009 DISCN SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AND ADMINISTRATION OF AN ORAL NSAID.
2% PENNSAID HORIZON N204623 Jan. 16, 2014 RX SOLUTION TOPICAL 8546450 Aug. 9, 2030 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM SUNSCREEN AND INSECT REPELLANT
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 RX SYSTEM TOPICAL 11344520 Feb. 20, 2035 METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED
1.3% LICART IBSA INST BIO N206976 Dec. 19, 2018 RX SYSTEM TOPICAL 11351133 Feb. 20, 2035 METHOD OF TREATING ACUTE PAIN DUE TO MINOR STRAINS, SPRAINS, AND CONTUSIONS USING A DICLOFENAC PATCH CONTAINING HEPARIN FOR ONCE DAILY ADMINISTRATION WHERE HEPARIN IS NOT RELEASED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG ZIPSOR ASSERTIO N022202 June 16, 2009 RX CAPSULE ORAL May 25, 2024 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostaglandin G/H synthase 2 Enzyme INHIBITOR IC50 7.70 WOMBAT-PK CHEMBL
Prostaglandin G/H synthase 1 Enzyme INHIBITOR IC50 7.52 WOMBAT-PK CHEMBL
Transthyretin Secreted Kd 6 CHEMBL
Aldo-keto reductase family 1 member C3 Enzyme IC50 5.59 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor ANTAGONIST Ki 6.20 IUPHAR
Cytochrome c oxidase subunit 2 Enzyme IC50 5 CHEMBL
Interleukin-8 Cytokine IC50 8.10 CHEMBL
Transient receptor potential cation channel subfamily A member 1 Ion channel EC50 4.25 CHEMBL
Aldo-keto reductase family 1 member B10 Enzyme IC50 5.72 CHEMBL
Acid-sensing ion channel 3 Ion channel BLOCKER IC50 4 IUPHAR
C-X-C chemokine receptor type 1 GPCR IC50 7.92 CHEMBL
UDP-glucuronosyltransferase 1-1 Enzyme Ki 4.28 CHEMBL
UDP-glucuronosyltransferase 1-7 Enzyme Ki 4.72 CHEMBL
UDP-glucuronosyltransferase 1-6 Enzyme Ki 4.64 CHEMBL
UDP-glucuronosyltransferase 1-9 Enzyme Ki 4.96 CHEMBL
UDP-glucuronosyltransferase 1-10 Enzyme Ki 4.55 CHEMBL
Transient receptor potential cation channel subfamily M member 3 Ion channel BLOCKER IC50 5.20 IUPHAR
Fatty acid-binding protein, liver Unclassified Ki 5.49 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.66 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 7.17 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 7.22 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.52 CHEMBL

External reference:

IDSource
4019714 VUID
N0000147806 NUI
D00903 KEGG_DRUG
88170-10-9 SECONDARY_CAS_RN
78213-16-8 SECONDARY_CAS_RN
15307-79-6 SECONDARY_CAS_RN
15307-81-0 SECONDARY_CAS_RN
119623-66-4 SECONDARY_CAS_RN
203214 RXNORM
4019378 VANDF
4019714 VANDF
4020829 VANDF
4027248 VANDF
C0012091 UMLSCUI
CHEBI:47381 CHEBI
DIF PDB_CHEM_ID
CHEMBL139 ChEMBL_ID
CHEMBL1034 ChEMBL_ID
DB00586 DRUGBANK_ID
CHEMBL1200804 ChEMBL_ID
CHEMBL1201180 ChEMBL_ID
D004008 MESH_DESCRIPTOR_UI
C000614065 MESH_SUPPLEMENTAL_RECORD_UI
C064142 MESH_SUPPLEMENTAL_RECORD_UI
3033 PUBCHEM_CID
2714 IUPHAR_LIGAND_ID
3270 INN_ID
144O8QL0L1 UNII
11838 MMSL
23373 MMSL
3184 MMSL
340620 MMSL
37364 MMSL
4582 MMSL
4583 MMSL
4584 MMSL
d00848 MMSL
002391 NDDF
004409 NDDF
004410 NDDF
005170 NDDF
006237 NDDF
108515008 SNOMEDCT_US
363598004 SNOMEDCT_US
425650004 SNOMEDCT_US
426714006 SNOMEDCT_US
62039007 SNOMEDCT_US
7034005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1411 TABLET, FILM COATED 50 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 33 sections
VoltarenArthritis Pain HUMAN OTC DRUG LABEL 1 0067-8152 GEL 10 mg TOPICAL NDA 18 sections
VOLTAREN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0478 SOLUTION 1 mg OPHTHALMIC NDA 16 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0093-0948 TABLET, FILM COATED 50 mg ORAL ANDA 14 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3225 PATCH 0.01 g TOPICAL NDA authorized generic 30 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA authorized generic 31 sections
diclofenac epolamine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3727 SYSTEM 0.01 g TOPICAL NDA authorized generic 31 sections
good sense arthritis pain HUMAN OTC DRUG LABEL 1 0113-1189 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0115-1483 GEL 30 mg TOPICAL ANDA 15 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0803 GEL 30 mg TOPICAL NDA authorized generic 27 sections
DICLOFENAC SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 0168-0844 GEL 30 mg TOPICAL NDA authorized generic 27 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2550 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0228-2551 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 26 sections
Aleve Arthritis Pain Gel HUMAN OTC DRUG LABEL 1 0280-0039 GEL 1 mg TOPICAL ANDA 17 sections
Aleve Arthritis Pain Gel HUMAN OTC DRUG LABEL 1 0280-0039 GEL 1 mg TOPICAL ANDA 17 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1210 GEL 10 mg TOPICAL ANDA 17 sections
diclofenac sodium HUMAN OTC DRUG LABEL 1 0363-1871 GEL 10 mg TOPICAL ANDA 17 sections
Diclofenac Sodium Topical Gel 1% Human OTC Drug Label 1 0363-7065 GEL 10 mg TOPICAL ANDA 15 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2474 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Diclofenac Potassium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2474 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-8750 GEL 10 mg TOPICAL ANDA 28 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0472-1783 GEL 30 mg TOPICAL ANDA 25 sections
Diclofenac potassium HUMAN PRESCRIPTION DRUG LABEL 1 0480-9435 CAPSULE, LIQUID FILLED 25 mg ORAL ANDA 23 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-2170 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 13 sections