diclofenac ๐Ÿถ 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 ยตM/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 1777.32 9.71 2378 215163 117788 50269795
Glossodynia 1654.01 9.71 2251 215290 113318 50274265
Systemic lupus erythematosus 1567.11 9.71 2433 215108 138189 50249394
Hand deformity 1439.85 9.71 1956 215585 98243 50289340
Rheumatoid arthritis 1406.80 9.71 2848 214693 199702 50187881
Wound 1294.91 9.71 1913 215628 103881 50283702
Pericarditis 1254.82 9.71 1617 215924 77072 50310511
Abdominal discomfort 1190.13 9.71 2887 214654 228754 50158829
Discomfort 1185.29 9.71 1860 215681 106520 50281063
Anti-cyclic citrullinated peptide antibody positive 1110.37 9.71 1441 216100 69146 50318437
Arthropathy 1069.90 9.71 2199 215342 155707 50231876
Alopecia 882.08 9.71 2680 214861 242367 50145216
Synovitis 810.24 9.71 1701 215840 122164 50265419
Swelling 803.82 9.71 2282 215259 198590 50188993
Contraindicated product administered 796.29 9.71 1887 215654 147071 50240512
Maternal exposure during pregnancy 786.87 9.71 1961 215580 157817 50229766
Duodenal ulcer perforation 786.33 9.71 975 216566 44636 50342947
Helicobacter infection 706.45 9.71 966 216575 48736 50338847
Embolia cutis medicamentosa 701.03 9.71 178 217363 121 50387462
Infusion related reaction 615.25 9.71 1861 215680 167696 50219887
Product use issue 606.95 9.71 1708 215833 147767 50239816
Hepatic enzyme increased 580.60 9.71 1593 215948 135787 50251796
Rheumatoid factor positive 558.55 9.71 866 216675 48993 50338590
Death 485.40 9.71 412 217129 324967 50062616
Hypersensitivity 471.52 9.71 2002 215539 213159 50174424
Treatment failure 462.16 9.71 1471 216070 136166 50251417
Drug intolerance 418.39 9.71 1957 215584 217147 50170436
Joint swelling 415.59 9.71 2117 215424 243169 50144414
Pain 384.56 9.71 3984 213557 574919 49812664
Rash 298.41 9.71 3029 214512 434442 49953141
Blister 291.06 9.71 918 216623 84500 50303083
Rheumatic fever 273.67 9.71 350 217191 16517 50371066
Muscle injury 271.01 9.71 534 217007 36577 50351006
Swollen joint count increased 262.66 9.71 322 217219 14551 50373032
Folliculitis 260.96 9.71 543 216998 38682 50348901
Diarrhoea 254.07 9.71 1489 216052 586987 49800596
Sleep disorder due to general medical condition, insomnia type 247.37 9.71 467 217074 30980 50356603
Hip arthroplasty 241.99 9.71 454 217087 29975 50357608
Completed suicide 234.39 9.71 138 217403 131751 50255832
Irritable bowel syndrome 232.48 9.71 612 216929 50829 50336754
Febrile neutropenia 230.18 9.71 67 217474 97600 50289983
Therapeutic product effect decreased 223.45 9.71 1165 216376 134885 50252698
Neutropenia 221.84 9.71 186 217355 147779 50239804
Deafness transitory 216.98 9.71 120 217421 1676 50385907
Musculoskeletal stiffness 207.40 9.71 1095 216446 127386 50260197
Pneumonia 206.70 9.71 881 216660 377520 50010063
Knee arthroplasty 196.30 9.71 459 217082 35387 50352196
Toxicity to various agents 192.18 9.71 390 217151 212109 50175474
Gastrointestinal disorder 167.73 9.71 827 216714 93629 50293954
Impaired healing 155.19 9.71 653 216888 69133 50318450
Nausea 148.35 9.71 2140 215401 703258 49684325
Cough 138.82 9.71 550 216991 240714 50146869
Type 2 diabetes mellitus 138.34 9.71 392 217149 33983 50353600
Hypotension 136.62 9.71 535 217006 234934 50152649
Cardiac failure congestive 134.05 9.71 100 217441 84282 50303301
Product dose omission issue 133.90 9.71 378 217163 183460 50204123
Gastric ulcer perforation 130.22 9.71 72 217469 1005 50386578
Thrombocytopenia 127.97 9.71 220 217321 127453 50260130
Melaena 118.68 9.71 317 217224 26547 50361036
Blood cholesterol increased 116.83 9.71 509 217032 54706 50332877
Gastric ulcer 116.83 9.71 273 217268 21032 50366551
Sleep disorder 112.14 9.71 516 217025 56767 50330816
Gastrointestinal pain 111.96 9.71 155 217386 7901 50379682
Seizure 108.45 9.71 214 217327 117660 50269923
Fall 108.37 9.71 920 216621 334012 50053571
Electrocardiogram QT prolonged 107.70 9.71 44 217497 51842 50335741
Ankylosing spondylitis 107.38 9.71 143 217398 7022 50380561
Pharyngitis 106.80 9.71 234 217307 17269 50370314
Dehydration 104.79 9.71 322 217219 152127 50235456
Psoriatic arthropathy 102.91 9.71 438 217103 46594 50340989
Ear infection 102.40 9.71 294 217247 25676 50361907
Constipation 101.35 9.71 432 217109 185276 50202307
Device expulsion 94.01 9.71 8 217533 28814 50358769
Urinary tract infection 90.80 9.71 577 216964 223443 50164140
Pancytopenia 89.59 9.71 139 217402 83891 50303692
Hypokalaemia 88.72 9.71 151 217390 87841 50299742
Atrial fibrillation 87.44 9.71 192 217349 101553 50286030
General physical health deterioration 85.66 9.71 963 216578 141471 50246112
Asthenia 82.24 9.71 926 216615 318116 50069467
White blood cell count decreased 82.00 9.71 244 217297 116478 50271105
Shoulder arthroplasty 80.04 9.71 86 217455 3362 50384221
Anxiety 77.96 9.71 446 217095 177160 50210423
Infection 77.84 9.71 1108 216433 171846 50215737
Hospitalisation 77.69 9.71 107 217434 67830 50319753
Cerebrovascular accident 77.05 9.71 184 217357 94496 50293087
Anaphylactic shock 76.41 9.71 225 217316 19930 50367653
Off label use 76.24 9.71 1510 216031 472916 49914667
Live birth 74.89 9.71 196 217345 16212 50371371
Ill-defined disorder 72.37 9.71 442 217099 54212 50333371
Cardiac arrest 71.75 9.71 158 217383 83493 50304090
Leukopenia 71.70 9.71 112 217429 67416 50320167
Liver injury 71.41 9.71 252 217289 24554 50363029
Sepsis 70.78 9.71 312 217229 132613 50254970
Disease progression 70.55 9.71 196 217345 95670 50291913
Platelet count decreased 70.43 9.71 211 217330 100515 50287068
Neuropathy peripheral 69.60 9.71 200 217341 96557 50291026
Duodenal ulcer 69.35 9.71 113 217428 6662 50380921
Angioedema 67.61 9.71 331 217210 37345 50350238
Grip strength decreased 66.10 9.71 155 217386 11966 50375617
Dyspnoea 65.39 9.71 1824 215717 545784 49841799
Neutrophil count decreased 65.12 9.71 61 217480 45965 50341618
Anaemia 62.94 9.71 738 216803 251718 50135865
Stomatitis 61.72 9.71 687 216854 100657 50286926
Arthralgia 61.46 9.71 2385 215156 436317 49951266
Tonsillar ulcer 60.29 9.71 28 217513 263 50387320
Intestinal diaphragm disease 59.14 9.71 21 217520 89 50387494
Oxygen saturation decreased 58.28 9.71 144 217397 73104 50314479
Red blood cell sedimentation rate abnormal 57.81 9.71 3 217538 16340 50371243
Cardio-respiratory arrest 57.57 9.71 89 217452 53803 50333780
Hypoxia 56.97 9.71 82 217459 51041 50336542
Balance disorder 56.78 9.71 138 217403 70452 50317131
Lower respiratory tract infection 56.44 9.71 642 216899 94559 50293024
Epistaxis 56.33 9.71 119 217422 63835 50323748
Fluid retention 55.70 9.71 82 217459 50567 50337016
Plasma cell myeloma 55.27 9.71 33 217508 31289 50356294
Cardiac failure 54.08 9.71 158 217383 75882 50311701
Insomnia 53.47 9.71 487 217054 174378 50213205
Cognitive disorder 52.99 9.71 67 217474 44056 50343527
Coma 52.51 9.71 103 217438 56776 50330807
Pleural effusion 52.47 9.71 177 217364 81277 50306306
Drug ineffective 51.68 9.71 4137 213404 815196 49572387
Large intestinal stenosis 51.02 9.71 49 217492 1673 50385910
Small intestine ulcer 50.52 9.71 26 217515 311 50387272
Hypoglycaemia 50.36 9.71 96 217445 53485 50334098
Mental status changes 50.23 9.71 49 217492 36223 50351360
Pulmonary arterial hypertension 49.60 9.71 13 217528 20306 50367277
Type I hypersensitivity 49.34 9.71 56 217485 2329 50385254
Functional gastrointestinal disorder 48.99 9.71 67 217474 3375 50384208
Heart rate increased 48.99 9.71 169 217372 77081 50310502
Anaphylactic reaction 48.60 9.71 398 217143 53657 50333926
Injection site pain 48.57 9.71 279 217262 110745 50276838
Renal failure neonatal 48.54 9.71 21 217520 164 50387419
Contusion 48.17 9.71 713 216828 111470 50276113
Bradycardia 47.93 9.71 131 217410 64295 50323288
Fatigue 47.54 9.71 3591 213950 704010 49683573
Clostridium difficile infection 47.48 9.71 25 217516 25414 50362169
Wrong technique in product usage process 47.47 9.71 105 217436 55405 50332178
Pulmonary embolism 46.99 9.71 251 217290 101453 50286130
Multiple sclerosis relapse 46.81 9.71 70 217471 42894 50344689
Ductus arteriosus stenosis foetal 46.81 9.71 20 217521 151 50387432
Intentional product use issue 46.17 9.71 520 217021 76398 50311185
Mucosal inflammation 46.11 9.71 63 217478 40079 50347504
Fat necrosis 45.96 9.71 30 217511 575 50387008
Neoplasm progression 45.71 9.71 35 217506 29122 50358461
Large intestinal ulcer 45.60 9.71 61 217480 3008 50384575
Malignant neoplasm progression 45.28 9.71 146 217395 67978 50319605
Tachycardia 45.11 9.71 248 217293 99515 50288068
Respiratory failure 44.98 9.71 220 217321 90961 50296622
Pulmonary oedema 44.85 9.71 89 217452 48849 50338734
Vomiting 44.64 9.71 1577 215964 459181 49928402
Ileal ulcer 43.87 9.71 26 217515 417 50387166
Myocardial infarction 43.80 9.71 215 217326 88812 50298771
No adverse event 43.52 9.71 48 217493 33530 50354053
Pancreatitis 43.05 9.71 73 217468 42541 50345042
Blood glucose increased 41.95 9.71 161 217380 71163 50316420
Lethargy 41.86 9.71 94 217447 49338 50338245
Osteoarthritis 41.72 9.71 465 217076 68141 50319442
Posterior reversible encephalopathy syndrome 41.67 9.71 7 217534 14921 50372662
Pneumonia aspiration 41.66 9.71 43 217498 30961 50356622
Depression 41.40 9.71 483 217058 164940 50222643
Gastrointestinal erosion 41.35 9.71 28 217513 572 50387011
Respiratory distress 41.29 9.71 42 217499 30447 50357136
Oligohydramnios 41.06 9.71 82 217459 5668 50381915
Injection site necrosis 40.20 9.71 37 217504 1196 50386387
Ductus arteriosus premature closure 39.98 9.71 22 217519 304 50387279
Hyperglycaemia 39.97 9.71 59 217482 36346 50351237
Device dislocation 39.01 9.71 22 217519 21524 50366059
Feeding disorder 38.82 9.71 117 217424 10496 50377087
Lower respiratory tract infection viral 38.68 9.71 28 217513 639 50386944
Chest discomfort 38.44 9.71 237 217304 92485 50295098
Acute myeloid leukaemia 38.04 9.71 9 217532 15065 50372518
Foot operation 37.47 9.71 77 217464 5433 50382150
COVID-19 36.91 9.71 92 217449 46570 50341013
Duodenal ulcer haemorrhage 36.80 9.71 46 217495 2120 50385463
Blood potassium decreased 36.67 9.71 64 217477 36881 50350702
Foetal methotrexate syndrome 36.63 9.71 14 217527 76 50387507
Complication associated with device 36.49 9.71 9 217532 14646 50372937
Therapeutic product effect incomplete 36.35 9.71 237 217304 91278 50296305
Endoscopy abnormal 36.13 9.71 9 217532 5 50387578
Jejunal ulcer 34.93 9.71 14 217527 88 50387495
Abdominal pain 34.81 9.71 762 216779 235466 50152117
Diabetes mellitus 34.77 9.71 102 217439 48931 50338652
Unevaluable event 34.76 9.71 93 217448 45973 50341610
Bronchitis 34.52 9.71 284 217257 103875 50283708
Cytomegalovirus infection 34.50 9.71 17 217524 17945 50369638
Condition aggravated 34.04 9.71 1582 215959 295476 50092107
Gastritis erosive 34.04 9.71 71 217470 5063 50382520
Injection site erythema 34.02 9.71 186 217355 74750 50312833
Drug abuse 33.97 9.71 137 217404 59709 50327874
Neuroleptic malignant syndrome 33.92 9.71 4 217537 11126 50376457
Premature delivery 33.90 9.71 31 217510 23632 50363951
Porphyria acute 33.79 9.71 23 217518 474 50387109
Injection site bruising 33.57 9.71 67 217474 36701 50350882
Hypomagnesaemia 33.57 9.71 30 217511 23126 50364457
Influenza 33.03 9.71 237 217304 89301 50298282
Laboratory test abnormal 32.54 9.71 31 217510 23177 50364406
Chills 32.33 9.71 263 217278 96424 50291159
Unresponsive to stimuli 32.26 9.71 51 217490 30558 50357025
Incorrect dose administered 32.00 9.71 104 217437 48310 50339273
Aspirin-exacerbated respiratory disease 32.00 9.71 28 217513 846 50386737
Drug tolerance decreased 30.74 9.71 98 217443 9062 50378521
Haematemesis 30.46 9.71 214 217327 27511 50360072
Transplant rejection 30.44 9.71 3 217538 9606 50377977
Sedation 30.40 9.71 53 217488 30557 50357026
Hypervolaemia 30.32 9.71 39 217502 25460 50362123
Sacroiliitis 30.30 9.71 46 217495 2551 50385032
Hyponatraemia 30.12 9.71 266 217275 95873 50291710
Torsade de pointes 30.00 9.71 7 217534 11828 50375755
Chronic obstructive pulmonary disease 29.90 9.71 123 217418 53312 50334271
Neurotoxicity 29.78 9.71 13 217528 14727 50372856
Upper respiratory tract infection 29.68 9.71 164 217377 65734 50321849
Deep vein thrombosis 29.54 9.71 189 217352 73115 50314468
Product quality issue 29.24 9.71 55 217486 30803 50356780
Palmar-plantar erythrodysaesthesia syndrome 29.18 9.71 26 217515 20072 50367511
Device issue 28.81 9.71 26 217515 19946 50367637
Spinal stenosis 28.71 9.71 125 217416 13425 50374158
Joint dislocation 28.64 9.71 117 217424 12216 50375367
Full blood count abnormal 28.62 9.71 35 217506 23353 50364230
Paranoia 28.56 9.71 5 217536 10343 50377240
Headache 28.40 9.71 1837 215704 504698 49882885
Dry skin 28.39 9.71 93 217448 43098 50344485
Periorbital oedema 28.32 9.71 65 217476 4947 50382636
Bone marrow failure 28.20 9.71 47 217494 27577 50360006
Metastases to liver 28.02 9.71 27 217514 20077 50367506
Agitation 27.97 9.71 126 217415 53258 50334325
Flushing 27.92 9.71 171 217370 66844 50320739
Abnormal loss of weight 27.88 9.71 65 217476 4999 50382584
Application site rash 27.86 9.71 42 217499 2315 50385268
Dysphagia 27.71 9.71 207 217334 77311 50310272
Urosepsis 27.70 9.71 16 217525 15449 50372134
Hallucination 27.63 9.71 105 217436 46552 50341031
Generalised tonic-clonic seizure 27.57 9.71 44 217497 26266 50361317
Hypercalcaemia 27.48 9.71 36 217505 23316 50364267
C-reactive protein abnormal 26.86 9.71 49 217492 27760 50359823
Ejection fraction decreased 26.84 9.71 24 217517 18496 50369087
Syncope 26.83 9.71 298 217243 102704 50284879
Status epilepticus 26.81 9.71 12 217529 13394 50374189
Chest pain 26.78 9.71 568 216973 176314 50211269
Liver function test abnormal 26.77 9.71 99 217442 44240 50343343
Progressive multifocal leukoencephalopathy 26.72 9.71 8 217533 11449 50376134
Transfusion 26.68 9.71 11 217530 12894 50374689
Ascites 26.61 9.71 73 217468 35788 50351795
Underdose 26.26 9.71 29 217512 20249 50367334
Sopor 26.22 9.71 28 217513 19851 50367732
Intestinal ulcer 26.15 9.71 28 217513 1090 50386493
Extrapyramidal disorder 26.06 9.71 9 217532 11761 50375822
Septic shock 25.90 9.71 142 217399 57033 50330550
Large intestine perforation 25.90 9.71 81 217460 7413 50380170
Dislocation of vertebra 25.71 9.71 47 217494 3040 50384543
Neonatal intestinal perforation 25.69 9.71 8 217533 20 50387563
Dyspnoea exertional 25.61 9.71 123 217418 51110 50336473
Abnormal behaviour 25.58 9.71 28 217513 19630 50367953
Rotator cuff repair 25.33 9.71 34 217507 1682 50385901
Hypocalcaemia 25.23 9.71 48 217493 26768 50360815
Tenderness 25.11 9.71 151 217390 18414 50369169
Injection site reaction 25.08 9.71 120 217421 49912 50337671
Akathisia 24.98 9.71 3 217538 8226 50379357
Blood pressure increased 24.96 9.71 412 217129 132720 50254863
Aggression 24.39 9.71 33 217508 21083 50366500
Respiratory disorder 24.26 9.71 62 217479 31125 50356458
Asthma 24.25 9.71 256 217285 89081 50298502
Nasal congestion 24.25 9.71 125 217416 50995 50336588
Orthostatic hypotension 24.20 9.71 57 217484 29424 50358159
Renal failure 24.15 9.71 318 217223 106315 50281268
Corneal epithelium defect 23.97 9.71 16 217525 319 50387264
Pyrexia 23.89 9.71 1364 216177 378839 50008744
Diabetic ketoacidosis 23.77 9.71 25 217516 17847 50369736
Drug resistance 23.68 9.71 28 217513 18961 50368622
Abdominal rebound tenderness 23.55 9.71 7 217534 14 50387569
Keratopathy 23.46 9.71 18 217523 450 50387133
Tubulointerstitial nephritis 23.37 9.71 128 217413 15083 50372500
Feeling abnormal 23.32 9.71 389 217152 125103 50262480
Productive cough 23.26 9.71 132 217409 52562 50335021
Synostosis 23.08 9.71 9 217532 52 50387531
Orbital oedema 23.05 9.71 13 217528 189 50387394
Gastric ulcer haemorrhage 23.00 9.71 56 217485 4428 50383155
Neonatal respiratory acidosis 22.93 9.71 12 217529 149 50387434
Peritonitis 22.92 9.71 129 217412 15357 50372226
Soft tissue injury 22.82 9.71 30 217511 1454 50386129
Myelosuppression 22.80 9.71 15 217526 13502 50374081
Tremor 22.74 9.71 352 217189 114551 50273032
Atelectasis 22.72 9.71 27 217514 18243 50369340
Congenital pulmonary hypertension 22.67 9.71 9 217532 55 50387528
Sedation complication 22.59 9.71 5 217536 8761 50378822
Right ventricular failure 22.55 9.71 21 217520 15872 50371711
Intestinal obstruction 22.47 9.71 50 217491 26333 50361250
Psychotic disorder 22.37 9.71 37 217504 21775 50365808
Liver function test increased 22.25 9.71 48 217493 25558 50362025
Cellulitis 22.12 9.71 196 217345 70602 50316981
Cytokine release syndrome 22.10 9.71 5 217536 8629 50378954
Accidental exposure to product 21.93 9.71 41 217500 23016 50364567
Treatment noncompliance 21.90 9.71 62 217479 30088 50357495
Encephalopathy 21.87 9.71 73 217468 33638 50353945
Palpitations 21.71 9.71 281 217260 94225 50293358
Myocarditis 21.59 9.71 4 217537 7943 50379640
Lymphatic fistula 21.58 9.71 21 217520 729 50386854
Hepatic failure 21.57 9.71 69 217472 32214 50355369
Blood glucose decreased 21.50 9.71 28 217513 18183 50369400
Mania 21.47 9.71 10 217531 10906 50376677
Infective pulmonary exacerbation of cystic fibrosis 21.44 9.71 4 217537 7905 50379678
Retinitis 21.42 9.71 33 217508 1854 50385729
Haematotoxicity 21.39 9.71 4 217537 7891 50379692
Ovulation disorder 21.32 9.71 7 217534 22 50387561
Femoral hernia incarcerated 21.32 9.71 21 217520 740 50386843
Cardiac disorder 21.01 9.71 104 217437 42875 50344708
Malaise 20.83 9.71 1205 216336 334327 50053256
Deafness 20.82 9.71 127 217414 15564 50372019
Seronegative arthritis 20.59 9.71 34 217507 2027 50385556
Bacteraemia 20.56 9.71 19 217522 14414 50373169
Somnolence 20.55 9.71 508 217033 154477 50233106
Maternal exposure timing unspecified 20.52 9.71 47 217494 3573 50384010
Soft tissue infection 20.35 9.71 32 217509 1830 50385753
Frequent bowel movements 20.21 9.71 18 217523 13900 50373683
Sinus disorder 20.17 9.71 30 217511 18428 50369155
Neoplasm malignant 20.15 9.71 45 217496 23670 50363913
Fibromyalgia 20.13 9.71 288 217253 44690 50342893
Therapy cessation 20.01 9.71 52 217489 25959 50361624
Arteriovenous fistula occlusion 19.93 9.71 15 217526 364 50387219
Abortion spontaneous 19.89 9.71 102 217439 41670 50345913
Rheumatoid lung 19.86 9.71 37 217504 2428 50385155
Second primary malignancy 19.84 9.71 3 217538 6911 50380672
Gestational diabetes 19.76 9.71 4 217537 7461 50380122
Hypochromic anaemia 19.73 9.71 30 217511 1666 50385917
Neutropenic sepsis 19.71 9.71 19 217522 14128 50373455
Lip ulceration 19.70 9.71 31 217510 1774 50385809
Blood calcium decreased 19.54 9.71 37 217504 20669 50366914
Pancreatic steatosis 19.53 9.71 22 217519 907 50386676
Cyanosis neonatal 19.39 9.71 13 217528 261 50387322
Influenza like illness 19.33 9.71 156 217385 57303 50330280
Muscle tone disorder 19.33 9.71 10 217531 121 50387462
Heavy menstrual bleeding 19.28 9.71 23 217518 15514 50372069
Vision blurred 19.13 9.71 231 217310 78416 50309167
Injection site pruritus 19.06 9.71 99 217442 40312 50347271
Bone disorder 19.05 9.71 32 217509 18720 50368863
Pericardial effusion 19.05 9.71 52 217489 25537 50362046
Blue toe syndrome 19.01 9.71 15 217526 391 50387192
Thrombotic microangiopathy 18.99 9.71 7 217534 8784 50378799
Urinoma 18.95 9.71 7 217534 34 50387549
Libido increased 18.92 9.71 25 217516 1218 50386365
Femur-fibula-ulna complex 18.82 9.71 5 217536 5 50387578
Suicidal ideation 18.81 9.71 150 217391 55235 50332348
Adjustment disorder with depressed mood 18.75 9.71 39 217502 2775 50384808
Muscle spasms 18.75 9.71 404 217137 125149 50262434
Device related infection 18.74 9.71 38 217503 20697 50366886
Weight decreased 18.74 9.71 769 216772 220476 50167107
Punctate keratitis 18.72 9.71 17 217524 540 50387043
Ataxia 18.65 9.71 19 217522 13767 50373816
Emotional distress 18.64 9.71 62 217479 28601 50358982
Throat irritation 18.59 9.71 67 217474 30172 50357411
Stress 18.58 9.71 145 217396 53648 50333935
Gallbladder adenocarcinoma 18.55 9.71 9 217532 94 50387489
Full blood count decreased 18.51 9.71 43 217498 22303 50365280
Blood test abnormal 18.50 9.71 13 217528 11306 50376277
Kounis syndrome 18.46 9.71 24 217517 1151 50386432
Creutzfeldt-Jakob disease 18.38 9.71 10 217531 135 50387448
Macular degeneration 18.17 9.71 21 217520 14367 50373216
Lymphocyte stimulation test positive 18.10 9.71 16 217525 490 50387093
Pulmonary hypertension 18.03 9.71 78 217463 33339 50354244
Spinal pain 18.03 9.71 93 217448 10710 50376873
Depressed mood 18 9.71 80 217461 33943 50353640
Ventricular tachycardia 18.00 9.71 25 217516 15796 50371787
Amenorrhoea 17.92 9.71 7 217534 8477 50379106
Urine porphobilinogen increased 17.82 9.71 4 217537 0 50387583
Oral pain 17.80 9.71 52 217489 24981 50362602
Adactyly 17.74 9.71 7 217534 42 50387541
Rhabdomyolysis 17.64 9.71 97 217444 38930 50348653
Injury 17.60 9.71 302 217239 48623 50338960
Visual impairment 17.59 9.71 198 217343 68077 50319506
Fear 17.56 9.71 22 217519 14527 50373056
Schizophrenia 17.55 9.71 5 217536 7392 50380191
Dizziness 17.55 9.71 1267 216274 345102 50042481
Depressed level of consciousness 17.50 9.71 141 217400 51812 50335771
Injection site abscess 17.38 9.71 22 217519 1027 50386556
Blood pressure fluctuation 17.33 9.71 87 217454 35736 50351847
Central pain syndrome 17.22 9.71 11 217530 203 50387380
Adverse event 17.17 9.71 274 217267 43489 50344094
Complications of intestinal transplant 17.16 9.71 5 217536 9 50387574
Colitis erosive 17.15 9.71 8 217533 76 50387507
Metastases to bone 17.12 9.71 32 217509 17963 50369620
Metastases to central nervous system 17.11 9.71 14 217527 11268 50376315
Injection site hyperaesthesia 17.08 9.71 7 217534 47 50387536
Lymphocyte count decreased 17.04 9.71 57 217484 26250 50361333
Injection site haemorrhage 16.94 9.71 42 217499 21304 50366279
Gastrointestinal ulcer 16.94 9.71 29 217512 1781 50385802
Blood calcium increased 16.92 9.71 6 217535 7713 50379870
Central nervous system lesion 16.74 9.71 10 217531 9479 50378104
Small intestinal obstruction 16.72 9.71 27 217514 16041 50371542
Injection site mass 16.64 9.71 26 217515 15654 50371929
Intestinal haemorrhage 16.62 9.71 40 217501 3140 50384443
Respiratory tract congestion 16.59 9.71 22 217519 14177 50373406
Thyroid disorder 16.56 9.71 18 217523 12659 50374924
Back pain 16.52 9.71 775 216766 219255 50168328
Paraesthesia 16.51 9.71 392 217149 119851 50267732
Complication of device insertion 16.50 9.71 3 217538 6038 50381545
Joint range of motion decreased 16.47 9.71 136 217405 18376 50369207
Anterior chamber cell 16.45 9.71 15 217526 479 50387104
Vasoconstriction 16.37 9.71 15 217526 482 50387101
Libido disorder 16.37 9.71 7 217534 53 50387530
Osteonecrosis of jaw 16.31 9.71 78 217463 32448 50355135
Synovial cyst 16.29 9.71 74 217467 8092 50379491
Subdural haematoma 16.24 9.71 19 217522 12928 50374655
Injection site swelling 16.17 9.71 109 217432 41664 50345919
Haemoptysis 16.17 9.71 56 217485 25517 50362066
Psychomotor hyperactivity 16.13 9.71 10 217531 9291 50378292
Aspiration 16.01 9.71 10 217531 9254 50378329
Deep vein thrombosis postoperative 16.01 9.71 27 217514 1638 50385945
Homicide 15.84 9.71 13 217528 359 50387224
Cytopenia 15.83 9.71 9 217532 8766 50378817
Diabetes mellitus inadequate control 15.74 9.71 20 217521 13125 50374458
Haemorrhage intracranial 15.69 9.71 18 217523 12356 50375227
Wrist deformity 15.65 9.71 28 217513 1781 50385802
Failure to thrive 15.65 9.71 4 217537 6354 50381229
Palatal oedema 15.64 9.71 14 217527 436 50387147
Pyoderma streptococcal 15.59 9.71 4 217537 3 50387580
Mood swings 15.50 9.71 28 217513 15926 50371657
Peptic ulcer 15.46 9.71 44 217497 3822 50383761
Erythematotelangiectatic rosacea 15.40 9.71 5 217536 15 50387568
Oedema peripheral 15.37 9.71 540 217001 157421 50230162
Immunodeficiency 15.35 9.71 25 217516 14803 50372780
Cerebral haemorrhage 15.30 9.71 62 217479 26990 50360593
Haemoglobin decreased 15.26 9.71 423 217118 126793 50260790
Conjunctival hyperaemia 15.24 9.71 30 217511 2052 50385531
Urine abnormality 15.21 9.71 4 217537 6234 50381349
Lung neoplasm malignant 15.20 9.71 27 217514 15457 50372126
Musculoskeletal disorder 15.19 9.71 127 217414 17222 50370361
Arrhythmia 15.16 9.71 82 217459 33050 50354533
Oropharyngeal pain 15.16 9.71 239 217302 77562 50310021
Feeling cold 15.06 9.71 39 217502 19492 50368091
Peripheral swelling 15.04 9.71 1053 216488 204883 50182700
Bedridden 15.00 9.71 11 217530 9356 50378227
Panniculitis 14.94 9.71 9 217532 8494 50379089
Fungal infection 14.94 9.71 72 217469 29893 50357690
Multiple allergies 14.81 9.71 9 217532 8454 50379129
Clostridium difficile colitis 14.80 9.71 34 217507 17708 50369875
Basal ganglion degeneration 14.80 9.71 13 217528 395 50387188
Thrombosis 14.74 9.71 161 217380 55672 50331911
Obstructive airways disorder 14.74 9.71 28 217513 15624 50371959
Nephrolithiasis 14.72 9.71 88 217453 34605 50352978
Bladder disorder 14.70 9.71 7 217534 7536 50380047
Congenital tricuspid valve atresia 14.67 9.71 6 217535 40 50387543
Lymphopenia 14.66 9.71 28 217513 15593 50371990
Arterial haemorrhage 14.64 9.71 25 217516 1532 50386051
Cardiomyopathy 14.57 9.71 28 217513 15558 50372025
Infusion site pain 14.56 9.71 19 217522 12327 50375256
X-ray abnormal 14.55 9.71 34 217507 2618 50384965
Tongue disorder 14.52 9.71 11 217530 9205 50378378
Device occlusion 14.42 9.71 4 217537 6019 50381564
Loss of personal independence in daily activities 14.40 9.71 213 217328 69837 50317746
Porphyria 14.33 9.71 9 217532 161 50387422
Spinal cord infection 14.26 9.71 15 217526 572 50387011
Hypophagia 14.23 9.71 182 217359 27546 50360037
Product storage error 14.22 9.71 19 217522 12205 50375378
Haematocrit decreased 14.18 9.71 90 217451 34886 50352697
Papulopustular rosacea 14.12 9.71 5 217536 21 50387562
Wound infection pseudomonas 14.08 9.71 22 217519 1251 50386332
Enterococcal infection 14.07 9.71 6 217535 6892 50380691
Uterine perforation 14.04 9.71 5 217536 6410 50381173
Overdose 14.00 9.71 324 217217 99403 50288180
Necrotising fasciitis 13.87 9.71 33 217508 2571 50385012
Dysgeusia 13.87 9.71 104 217437 38812 50348771
Dyskinesia 13.86 9.71 67 217474 27794 50359789
Nodule 13.85 9.71 33 217508 16970 50370613
Lacrimation increased 13.83 9.71 33 217508 16959 50370624
Tardive dyskinesia 13.81 9.71 7 217534 7272 50380311
Acquired porphyria 13.75 9.71 5 217536 23 50387560
Porphyrins urine increased 13.75 9.71 5 217536 23 50387560
Iris transillumination defect 13.73 9.71 7 217534 82 50387501
Blood pressure abnormal 13.66 9.71 21 217520 12726 50374857
Nasopharyngitis 13.48 9.71 983 216558 191944 50195639
Hot flush 13.48 9.71 123 217418 44046 50343537
Laparotomy 13.46 9.71 9 217532 180 50387403
Therapy change 13.42 9.71 3 217538 5222 50382361
Anal erosion 13.42 9.71 5 217536 25 50387558
Bronchopulmonary aspergillosis 13.39 9.71 8 217533 7584 50379999
Haemorrhage 13.36 9.71 156 217385 53285 50334298
Application site eczema 13.36 9.71 3 217538 0 50387583
Pseudodiverticular disease 13.36 9.71 3 217538 0 50387583
Reticulocytosis 13.30 9.71 8 217533 132 50387451
Application site injury 13.26 9.71 5 217536 26 50387557
Hepatitis 13.23 9.71 80 217461 31373 50356210
Tissue infiltration 13.20 9.71 14 217527 539 50387044
Gastritis 13.12 9.71 207 217334 32776 50354807
Pulmonary toxicity 13.10 9.71 53 217488 5509 50382074
Oesophagitis ulcerative 13.04 9.71 13 217528 465 50387118
Salivary hypersecretion 13.02 9.71 6 217535 6585 50380998
Genital haemorrhage 12.96 9.71 6 217535 6568 50381015
Anti-cyclic citrullinated peptide antibody 12.96 9.71 24 217517 1568 50386015
Ischaemic stroke 12.96 9.71 31 217510 15917 50371666
Oesophageal carcinoma recurrent 12.95 9.71 5 217536 28 50387555
Fear of injection 12.95 9.71 5 217536 6098 50381485
Hypoproteinaemia 12.94 9.71 26 217515 1805 50385778
Femur fracture 12.93 9.71 101 217440 37363 50350220
Immunosuppression 12.85 9.71 8 217533 7418 50380165
Pharyngo-oesophageal diverticulum 12.85 9.71 4 217537 10 50387573
Application site ulcer 12.83 9.71 7 217534 95 50387488
Procedural pain 12.80 9.71 25 217516 13807 50373776
Respiratory arrest 12.80 9.71 76 217465 29933 50357650
Mood altered 12.79 9.71 22 217519 12751 50374832
Face oedema 12.77 9.71 125 217416 17714 50369869
Pruritus 12.76 9.71 1399 216142 282169 50105414
Analgesic drug level increased 12.74 9.71 25 217516 1706 50385877
Rhinorrhoea 12.74 9.71 151 217390 51432 50336151
Cholestasis 12.68 9.71 61 217480 25340 50362243
Porphyrins stool increased 12.67 9.71 5 217536 30 50387553
Upper-airway cough syndrome 12.49 9.71 11 217530 8539 50379044
Gastric haemorrhage 12.41 9.71 53 217488 5643 50381940
Alpha tumour necrosis factor increased 12.40 9.71 5 217536 32 50387551
Pneumonia viral 12.34 9.71 7 217534 6827 50380756
Acne 12.33 9.71 43 217498 19552 50368031
Neurological procedural complication 12.32 9.71 4 217537 12 50387571
Meteoropathy 12.32 9.71 4 217537 12 50387571
Systemic mastocytosis 12.32 9.71 8 217533 152 50387431
Cardiac murmur 12.31 9.71 17 217524 10767 50376816
Aspergillus infection 12.30 9.71 7 217534 6814 50380769
Red blood cell count decreased 12.26 9.71 90 217451 33745 50353838
Aphasia 12.24 9.71 72 217469 28422 50359161
Acute respiratory failure 12.22 9.71 73 217468 28709 50358874
Pre-eclampsia 12.17 9.71 10 217531 8034 50379549
Erythema 12.15 9.71 510 217031 145904 50241679
Staphylococcal bacteraemia 12.13 9.71 3 217538 4874 50382709
Retching 12.12 9.71 23 217518 12839 50374744
Cardiac massage 12.08 9.71 4 217537 13 50387570
Adverse drug reaction 12.08 9.71 317 217224 54905 50332678
Erythema induratum 12.05 9.71 8 217533 158 50387425
Suspected suicide 12.03 9.71 4 217537 5353 50382230
Diverticulum intestinal 12.01 9.71 54 217487 5879 50381704
Osteoporosis 12.01 9.71 129 217412 44750 50342833
Muscle spasticity 12.00 9.71 36 217505 17148 50370435
Device breakage 11.99 9.71 14 217527 9533 50378050
Bone pain 11.76 9.71 138 217403 47091 50340492
Hypovolaemia 11.75 9.71 14 217527 9451 50378132
Gallbladder disorder 11.74 9.71 35 217506 16707 50370876
Cushingoid 11.72 9.71 7 217534 6638 50380945
Seroma 11.67 9.71 25 217516 1816 50385767
Perforation bile duct 11.65 9.71 4 217537 15 50387568
Linear IgA disease 11.61 9.71 20 217521 1234 50386349
Transaminases increased 11.59 9.71 71 217470 27753 50359830
Granulocytopenia 11.58 9.71 4 217537 5227 50382356
Extravascular haemolysis 11.56 9.71 5 217536 39 50387544
Peripheral sensory neuropathy 11.55 9.71 7 217534 6584 50380999
Coagulopathy 11.54 9.71 39 217502 17905 50369678
Drug withdrawal syndrome 11.52 9.71 62 217479 25019 50362564
Caesarean section 11.48 9.71 32 217509 15607 50371976
Candida infection 11.45 9.71 57 217484 23466 50364117
Drug level decreased 11.36 9.71 7 217534 6526 50381057
Patellofemoral pain syndrome 11.33 9.71 13 217528 547 50387036
Emotional disorder 11.30 9.71 21 217520 11815 50375768
Venous valve ruptured 11.30 9.71 3 217538 3 50387580
Prescribed overdose 11.29 9.71 104 217437 14496 50373087
Upper limb fracture 11.27 9.71 33 217508 15840 50371743
Facet joint syndrome 11.19 9.71 29 217512 2384 50385199
Spondylitis 11.15 9.71 32 217509 2793 50384790
Hyperhidrosis 11.07 9.71 296 217245 89130 50298453
Hepatotoxicity 11.06 9.71 70 217471 27156 50360427
Piloerection 11.05 9.71 10 217531 316 50387267
Abdominal distension 11.05 9.71 234 217307 72669 50314914
Post-traumatic neck syndrome 11.05 9.71 25 217516 1885 50385698
Self-medication 11.04 9.71 28 217513 2271 50385312
Metastases to lung 11.02 9.71 19 217522 11001 50376582
Pulseless electrical activity 10.99 9.71 8 217533 6833 50380750
Pneumonitis chemical 10.96 9.71 8 217533 185 50387398
Mental impairment 10.95 9.71 22 217519 12022 50375561
Acute respiratory distress syndrome 10.93 9.71 50 217491 21049 50366534
Neonatal gastrointestinal haemorrhage 10.90 9.71 4 217537 19 50387564
Device difficult to use 10.87 9.71 16 217525 9870 50377713
Serotonin syndrome 10.85 9.71 62 217479 24651 50362932
Crying 10.80 9.71 48 217493 20368 50367215
Shock 10.79 9.71 136 217405 20514 50367069
pH body fluid decreased 10.73 9.71 4 217537 20 50387563
Urinary incontinence 10.72 9.71 74 217467 28134 50359449
Taste disorder 10.67 9.71 12 217529 8312 50379271
Stress ulcer 10.67 9.71 5 217536 48 50387535
Gastroenteritis viral 10.66 9.71 43 217498 18743 50368840
Dystonia 10.66 9.71 22 217519 11904 50375679
Confusional state 10.65 9.71 933 216608 184995 50202588
Intervertebral disc disorder 10.63 9.71 42 217499 4318 50383265
Nervous system disorder 10.61 9.71 35 217506 16188 50371395
Electrolyte imbalance 10.58 9.71 38 217503 17131 50370452
Kidney infection 10.58 9.71 43 217498 18703 50368880
Haemarthrosis 10.58 9.71 32 217509 2876 50384707
Tachypnoea 10.57 9.71 30 217511 14547 50373036
Haemorrhoids 10.57 9.71 44 217497 19009 50368574
Adrenal insufficiency 10.56 9.71 29 217512 14214 50373369
Heart rate irregular 10.56 9.71 45 217496 19315 50368268
Episcleritis 10.52 9.71 15 217526 786 50386797
Lipoedema 10.51 9.71 9 217532 264 50387319
Head titubation 10.49 9.71 14 217527 689 50386894
Extradural abscess 10.48 9.71 15 217526 789 50386794
Blood glucose abnormal 10.47 9.71 8 217533 6664 50380919
Inappropriate schedule of product administration 10.47 9.71 232 217309 71599 50315984
Adverse reaction 10.46 9.71 68 217473 8518 50379065
Injection site warmth 10.45 9.71 28 217513 13838 50373745
Tachyarrhythmia 10.38 9.71 40 217501 4065 50383518
Fistula 10.37 9.71 12 217529 8206 50379377
Intercepted product dispensing error 10.36 9.71 6 217535 92 50387491
Eyelid oedema 10.36 9.71 73 217468 9393 50378190
Microcytic anaemia 10.35 9.71 33 217508 3051 50384532
Vascular device infection 10.33 9.71 3 217538 4381 50383202
Exercise tolerance decreased 10.33 9.71 4 217537 4870 50382713
Device malfunction 10.33 9.71 32 217509 15089 50372494
Tumour lysis syndrome 10.30 9.71 10 217531 7411 50380172
Granuloma 10.27 9.71 4 217537 4854 50382729
Metabolic acidosis 10.23 9.71 112 217429 38713 50348870
Epstein-Barr virus infection 10.22 9.71 9 217532 6988 50380595
Anaesthesia 10.21 9.71 10 217531 350 50387233
Lupus vulgaris 10.20 9.71 13 217528 611 50386972
Tongue oedema 10.20 9.71 38 217503 3801 50383782
Encephalitis 10.18 9.71 10 217531 7370 50380213
Menstruation irregular 10.17 9.71 7 217534 6155 50381428
Ventricular hypoplasia 10.17 9.71 7 217534 147 50387436
Viral upper respiratory tract infection 10.17 9.71 58 217483 6938 50380645
Spinal fusion surgery 10.16 9.71 39 217502 3956 50383627
Sleep disorder due to a general medical condition 10.15 9.71 10 217531 7361 50380222
Metabolic disorder 10.15 9.71 5 217536 5281 50382302
Dementia 10.13 9.71 35 217506 15962 50371621
Hypogammaglobulinaemia 10.06 9.71 6 217535 5693 50381890
Bacterial infection 10.06 9.71 36 217505 16245 50371338
Axial spondyloarthritis 10.03 9.71 8 217533 212 50387371
Agonal rhythm 10.00 9.71 4 217537 25 50387558
Catheter site infection 9.98 9.71 3 217538 4283 50383300
Glycosylated haemoglobin increased 9.96 9.71 19 217522 10587 50376996
Injection site ulcer 9.96 9.71 12 217529 532 50387051
Product administered at inappropriate site 9.96 9.71 28 217513 2415 50385168
Hostility 9.95 9.71 23 217518 1759 50385824
Fibrosis 9.88 9.71 37 217504 3710 50383873
Small intestinal perforation 9.86 9.71 19 217522 1279 50386304
Myopathy 9.85 9.71 15 217526 9124 50378459
Respiratory tract infection 9.84 9.71 89 217452 31928 50355655
Atrioventricular dissociation 9.84 9.71 8 217533 218 50387365
Paranasal cyst 9.83 9.71 9 217532 289 50387294
Hyperammonaemia 9.81 9.71 4 217537 4720 50382863
Inclusion body myositis 9.78 9.71 3 217538 7 50387576
Ulcerative keratitis 9.77 9.71 27 217514 2306 50385277
Respiratory acidosis 9.75 9.71 7 217534 6021 50381562
Haemolysis 9.71 9.71 7 217534 6009 50381574

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 261.08 10.19 67 73446 136 29500878
Death 238.80 10.19 301 73212 341783 29159231
Melaena 211.69 10.19 320 73193 30856 29470158
Gastric ulcer 203.52 10.19 211 73302 13850 29487164
Ankylosing spondylitis 186.63 10.19 121 73392 4055 29496959
Duodenal ulcer 141.60 10.19 143 73370 9095 29491919
Onychoclasis 131.54 10.19 71 73442 1682 29499332
Febrile neutropenia 111.12 10.19 71 73442 112169 29388845
Off label use 110.75 10.19 381 73132 300419 29200595
Kounis syndrome 101.96 10.19 61 73452 1768 29499246
Gastritis erosive 100.59 10.19 93 73420 5300 29495714
Inflammation 97.06 10.19 190 73323 22538 29478476
Angioedema 96.45 10.19 232 73281 31683 29469331
Large intestinal stenosis 92.78 10.19 52 73461 1329 29499685
Anaphylactic shock 89.20 10.19 136 73377 13200 29487814
Gastric ulcer haemorrhage 88.29 10.19 83 73430 4831 29496183
Neutropenia 88.26 10.19 119 73394 131592 29369422
Psoriatic arthropathy 84.73 10.19 140 73373 14551 29486463
Tooth loss 79.69 10.19 69 73444 3605 29497409
Large intestinal ulcer 77.54 10.19 50 73463 1659 29499355
Lymphoma 75.52 10.19 107 73406 9721 29491293
Pruritus 74.83 10.19 522 72991 116327 29384687
Intestinal diaphragm disease 68.09 10.19 25 73488 224 29500790
Urticaria 67.44 10.19 292 73221 54368 29446646
Anaphylactic reaction 66.34 10.19 184 73329 27389 29473625
Duodenal ulcer perforation 65.73 10.19 43 73470 1463 29499551
Gastric haemorrhage 63.86 10.19 96 73417 9201 29491813
Arthralgia 63.75 10.19 577 72936 139040 29361974
Psoriasis 63.20 10.19 200 73313 32027 29468987
Cardiac failure congestive 60.05 10.19 61 73452 76520 29424494
Haematemesis 58.91 10.19 164 73349 24462 29476552
Macrocephaly 58.46 10.19 26 73487 397 29500617
Pyloric stenosis 58.02 10.19 31 73482 719 29500295
Type I hypersensitivity 57.81 10.19 35 73478 1037 29499977
Acute kidney injury 54.67 10.19 944 72569 264323 29236691
Joint swelling 54.37 10.19 256 73257 49374 29451640
Thrombocytopenia 54.13 10.19 164 73349 134659 29366355
Tubulointerstitial nephritis and uveitis syndrome 52.55 10.19 16 73497 74 29500940
C-reactive protein increased 51.96 10.19 233 73280 44030 29456984
Sacroiliitis 51.20 10.19 33 73480 1094 29499920
Musculoskeletal stiffness 50.78 10.19 206 73307 37252 29463762
Gastric ulcer perforation 50.75 10.19 30 73483 850 29500164
Toxicity to various agents 50.45 10.19 241 73272 173420 29327594
Metastases to stomach 49.33 10.19 15 73498 69 29500945
Application site rash 49.25 10.19 28 73485 736 29500278
Abdominal pain upper 49.18 10.19 289 73224 60704 29440310
Upper gastrointestinal haemorrhage 47.63 10.19 141 73372 21773 29479241
Spinal pain 41.95 10.19 56 73457 4808 29496206
Pain 41.56 10.19 627 72886 170805 29330209
Ductus arteriosus premature closure 41.32 10.19 17 73496 212 29500802
Arthritis 40.84 10.19 146 73367 24873 29476141
Muscle swelling 40.36 10.19 19 73494 333 29500681
Periorbital oedema 39.64 10.19 45 73468 3270 29497744
Seronegative arthritis 39.39 10.19 26 73487 898 29500116
Atrial fibrillation 39.24 10.19 133 73380 105513 29395501
Hospitalisation 39.13 10.19 34 73479 45954 29455060
Neoplasm malignant 38.79 10.19 111 73402 16814 29484200
Nephrotic syndrome 38.78 10.19 62 73451 6266 29494748
Ligament calcification 38.57 10.19 16 73497 204 29500810
Mucosal erosion 38.43 10.19 23 73490 667 29500347
Erythema 38.37 10.19 320 73193 75286 29425728
Neck pain 38.34 10.19 129 73384 21318 29479696
Antidepressant drug level above therapeutic 38.05 10.19 15 73498 166 29500848
Disease progression 37.82 10.19 93 73420 81823 29419191
Ulcerative keratitis 37.68 10.19 30 73483 1393 29499621
Analgesic drug level above therapeutic 36.11 10.19 16 73497 242 29500772
Injection site necrosis 36.05 10.19 18 73495 361 29500653
Gastrointestinal erosion 35.82 10.19 18 73495 366 29500648
Cerebrovascular accident 35.76 10.19 87 73426 76824 29424190
Drug tolerance decreased 34.84 10.19 28 73485 1318 29499696
Glomerulonephritis minimal lesion 34.75 10.19 18 73495 391 29500623
Product dose omission issue 34.67 10.19 123 73390 96260 29404754
Aspirin-exacerbated respiratory disease 33.68 10.19 17 73496 349 29500665
Bronchospasm 33.58 10.19 74 73439 9535 29491479
Erythema multiforme 33.52 10.19 65 73448 7652 29493362
Sepsis 32.18 10.19 215 73298 142467 29358547
Plasma cell myeloma 32.11 10.19 27 73486 37088 29463926
Blood pressure measurement 31.67 10.19 13 73500 161 29500853
Pneumonia 31.40 10.19 584 72929 319588 29181426
Corneal thinning 31.17 10.19 12 73501 124 29500890
Cerebral atrophy congenital 30.97 10.19 10 73503 58 29500956
Duodenal ulcer haemorrhage 30.40 10.19 46 73467 4433 29496581
Fractional exhaled nitric oxide increased 30.38 10.19 16 73497 360 29500654
Peptic ulcer 30.17 10.19 34 73479 2451 29498563
Mastoid abscess 30.00 10.19 6 73507 0 29501014
Alopecia 29.98 10.19 110 73403 18974 29482040
Toxic epidermal necrolysis 29.68 10.19 106 73407 18047 29482967
Erosive duodenitis 29.27 10.19 25 73488 1282 29499732
Blister 29.00 10.19 112 73401 19794 29481220
Conjunctival hyperaemia 28.91 10.19 31 73482 2114 29498900
Tubulointerstitial nephritis 28.82 10.19 103 73410 17540 29483474
Lymphocyte stimulation test positive 28.14 10.19 19 73494 682 29500332
Haematochezia 27.73 10.19 172 73341 36811 29464203
Hypomagnesaemia 27.62 10.19 5 73508 17463 29483551
Faeces discoloured 27.21 10.19 84 73429 13267 29487747
Electrocardiogram QT prolonged 26.95 10.19 30 73483 36107 29464907
Pancytopenia 26.76 10.19 111 73402 83057 29417957
Microcytic anaemia 26.75 10.19 29 73484 2002 29499012
Oral pruritus 26.67 10.19 13 73500 247 29500767
Application site reaction 26.22 10.19 15 73498 399 29500615
Sensation of foreign body 26.14 10.19 27 73486 1763 29499251
Platelet dysfunction 25.82 10.19 12 73501 204 29500810
Blood urea increased 25.82 10.19 138 73375 27974 29473040
Peritonitis 25.47 10.19 88 73425 14736 29486278
Gastrointestinal haemorrhage 25.46 10.19 306 73207 79227 29421787
Myoglobin blood increased 25.43 10.19 28 73485 1967 29499047
Fatigue 25.42 10.19 597 72916 316224 29184790
Malignant mesenteric neoplasm 25.13 10.19 8 73505 44 29500970
Gingivitis ulcerative 25.13 10.19 8 73505 44 29500970
Corneal perforation 25.09 10.19 11 73502 162 29500852
Renal failure neonatal 25.08 10.19 9 73504 75 29500939
Nerve stimulation test abnormal 25.00 10.19 5 73508 0 29501014
Application site swelling 24.76 10.19 12 73501 225 29500789
Blood lactate dehydrogenase increased 24.73 10.19 104 73409 19105 29481909
Anuria 24.26 10.19 65 73448 9476 29491538
Cardiac septal defect 24.20 10.19 12 73501 237 29500777
Disability 24.01 10.19 41 73472 4375 29496639
Cytomegalovirus infection 23.89 10.19 14 73499 23201 29477813
Right-to-left cardiac shunt 23.75 10.19 8 73505 54 29500960
Angiocardiogram 23.56 10.19 11 73502 189 29500825
Gastritis 23.08 10.19 103 73410 19414 29481600
Mental status changes 22.90 10.19 32 73481 34895 29466119
Hypotension 22.76 10.19 343 73170 194011 29307003
Palmoplantar pustulosis 22.72 10.19 9 73504 101 29500913
Platelet function test abnormal 22.64 10.19 9 73504 102 29500912
Corneal epithelium defect 22.55 10.19 13 73500 351 29500663
Cytokine release syndrome 22.46 10.19 3 73510 13116 29487898
Shock 22.40 10.19 109 73404 21295 29479719
Pulmonary embolism 22.29 10.19 106 73407 76428 29424586
Weight bearing difficulty 22.29 10.19 18 73495 853 29500161
Medium-chain acyl-coenzyme A dehydrogenase deficiency 22.22 10.19 7 73506 37 29500977
Fragile X syndrome 22.07 10.19 7 73506 38 29500976
Jejunal ulcer perforation 21.95 10.19 8 73505 70 29500944
Completed suicide 21.86 10.19 133 73380 90113 29410901
Cryopyrin associated periodic syndrome 21.76 10.19 8 73505 72 29500942
Swelling 21.58 10.19 156 73357 35127 29465887
Hypoaldosteronism 21.57 10.19 10 73503 169 29500845
Leukopenia 21.51 10.19 68 73445 55135 29445879
Subacute endocarditis 21.48 10.19 7 73506 42 29500972
Iris hypopigmentation 21.48 10.19 7 73506 42 29500972
Leptotrichia infection 21.47 10.19 8 73505 75 29500939
Deep vein thrombosis 21.47 10.19 72 73441 57327 29443687
Neurotoxicity 21.42 10.19 5 73508 14608 29486406
Joint space narrowing 21.38 10.19 8 73505 76 29500938
Mast cell activation syndrome 21.20 10.19 10 73503 176 29500838
Sciatic nerve injury 21.19 10.19 8 73505 78 29500936
Drug interaction 21.15 10.19 641 72872 196744 29304270
Uveitis 21.01 10.19 46 73467 5901 29495113
Factor VIII deficiency 20.94 10.19 9 73504 126 29500888
Neuropathy peripheral 20.91 10.19 98 73415 70929 29430085
Fibromyalgia 20.75 10.19 29 73484 2600 29498414
Body mass index abnormal 20.75 10.19 9 73504 129 29500885
Duodenal stenosis 20.61 10.19 10 73503 188 29500826
Intentional product use issue 20.60 10.19 47 73466 42451 29458563
Intervertebral disc compression 20.55 10.19 11 73502 256 29500758
Product administered at inappropriate site 19.98 10.19 23 73490 1697 29499317
Trisomy 8 19.44 10.19 7 73506 59 29500955
Application site erythema 19.39 10.19 25 73488 2074 29498940
Omental necrosis 19.32 10.19 6 73507 30 29500984
Necrotising fasciitis 19.30 10.19 32 73481 3333 29497681
Application site eczema 19.21 10.19 5 73508 11 29501003
Gastrointestinal ulcer 19.18 10.19 22 73491 1617 29499397
Contraindicated product administered 19.10 10.19 93 73420 18173 29482841
Abdominal lymphadenopathy 19.05 10.19 15 73498 685 29500329
Mesenteric neoplasm 19.00 10.19 6 73507 32 29500982
Intestinal congestion 18.91 10.19 5 73508 12 29501002
Eastern Cooperative Oncology Group performance status 18.85 10.19 6 73507 33 29500981
Back pain 18.84 10.19 358 73155 101926 29399088
Incorrect product administration duration 18.74 10.19 35 73478 4006 29497008
Kidney duplex 18.67 10.19 12 73501 396 29500618
Gastritis haemorrhagic 18.60 10.19 19 73494 1224 29499790
Gastric perforation 18.59 10.19 25 73488 2161 29498853
Hypoosmolar state 18.57 10.19 7 73506 68 29500946
Hypoglycaemia 18.52 10.19 60 73453 48286 29452728
Face oedema 18.51 10.19 62 73451 10221 29490793
Nephrolithiasis 18.47 10.19 117 73396 25217 29475797
Oropharyngeal discomfort 18.42 10.19 27 73486 2529 29498485
Eschar 18.39 10.19 14 73499 608 29500406
Tissue infiltration 18.30 10.19 7 73506 71 29500943
Pseudarthrosis 18.13 10.19 7 73506 73 29500941
Atrial septal defect 18.02 10.19 47 73466 6742 29494272
Secondary amyloidosis 17.88 10.19 7 73506 76 29500938
Exostosis 17.80 10.19 32 73481 3557 29497457
Twin pregnancy 17.77 10.19 4 73509 3 29501011
Secretion discharge 17.73 10.19 35 73478 4175 29496839
Neuroleptic malignant syndrome 17.69 10.19 9 73504 16139 29484875
Bacteroides infection 17.56 10.19 7 73506 80 29500934
Grip strength decreased 17.55 10.19 25 73488 2282 29498732
Intestinal metaplasia 17.41 10.19 5 73508 18 29500996
Abdominal pain 17.40 10.19 450 73063 134907 29366107
Intestinal ulcer 17.38 10.19 15 73498 780 29500234
Pallor 17.17 10.19 100 73413 20924 29480090
Acute myeloid leukaemia 16.93 10.19 10 73503 16503 29484511
Muscle abscess 16.89 10.19 12 73501 468 29500546
Hypoxia 16.66 10.19 61 73452 47318 29453696
Metastases to lung 16.55 10.19 50 73463 7805 29493209
Seizure 16.45 10.19 150 73363 92973 29408041
Mallory-Weiss syndrome 16.41 10.19 18 73495 1259 29499755
Lipoma 16.39 10.19 19 73494 1412 29499602
Plantar fasciitis 16.37 10.19 18 73495 1263 29499751
Mobility decreased 16.35 10.19 115 73398 25665 29475349
Hyperhidrosis 16.34 10.19 238 73275 64302 29436712
Skin ulcer 16.30 10.19 91 73422 18749 29482265
Hypervolaemia 16.13 10.19 12 73501 17533 29483481
Inflammatory bowel disease 16.06 10.19 24 73489 2287 29498727
Wound secretion 15.85 10.19 24 73489 2314 29498700
Gastric mucosa erythema 15.81 10.19 9 73504 237 29500777
Red blood cell sedimentation rate decreased 15.76 10.19 6 73507 60 29500954
Gastric mucosal lesion 15.73 10.19 12 73501 523 29500491
Application site vesicles 15.59 10.19 12 73501 530 29500484
Ureteral disorder 15.52 10.19 8 73505 172 29500842
Gastrointestinal mucosal exfoliation 15.50 10.19 7 73506 111 29500903
Arthritis bacterial 15.44 10.19 34 73479 4379 29496635
Cardio-respiratory arrest 15.37 10.19 69 73444 50532 29450482
Nikolsky's sign 15.27 10.19 8 73505 178 29500836
Cytopenia 15.21 10.19 3 73510 9856 29491158
Ciliary hyperaemia 15.21 10.19 5 73508 31 29500983
Application site oedema 15.21 10.19 5 73508 31 29500983
CADASIL 15.17 10.19 6 73507 67 29500947
Application site hypersensitivity 15.12 10.19 7 73506 118 29500896
Renal tubular necrosis 15.05 10.19 73 73440 14242 29486772
Leucine aminopeptidase increased 15.00 10.19 3 73510 0 29501014
Internal limiting membrane peeling 15.00 10.19 3 73510 0 29501014
Persistent corneal epithelial defect 14.94 10.19 5 73508 33 29500981
Diabetes mellitus 14.87 10.19 50 73463 39781 29461233
Magnetic resonance imaging spinal abnormal 14.86 10.19 6 73507 71 29500943
Inflammatory marker increased 14.86 10.19 30 73483 3637 29497377
Neisseria infection 14.74 10.19 4 73509 11 29501003
Oral mucosa erosion 14.72 10.19 14 73499 827 29500187
Oligoarthritis 14.64 10.19 6 73507 74 29500940
Full blood count decreased 14.63 10.19 11 73502 15981 29485033
Keratopathy 14.59 10.19 10 73503 368 29500646
Rhabdomyolysis 14.52 10.19 222 73291 60586 29440428
Visual evoked potentials abnormal 14.50 10.19 6 73507 76 29500938
Respiratory failure 14.44 10.19 163 73350 96968 29404046
Oropharyngeal pain 14.33 10.19 123 73390 29162 29471852
Jaundice 14.31 10.19 123 73390 29173 29471841
Retroperitoneal fibrosis 14.27 10.19 9 73504 287 29500727
Tongue oedema 14.18 10.19 24 73489 2542 29498472
Spondyloarthropathy 14.17 10.19 11 73502 492 29500522
Myelodysplastic syndrome 14.13 10.19 14 73499 17780 29483234
Microcephaly 14.11 10.19 13 73500 737 29500277
Energy increased 14.10 10.19 16 73497 1162 29499852
Duodenal perforation 14.06 10.19 16 73497 1166 29499848
Retinal toxicity 13.99 10.19 10 73503 394 29500620
Cognitive disorder 13.98 10.19 23 73490 23476 29477538
Corneal opacity 13.98 10.19 11 73502 502 29500512
Nasopharyngitis 13.93 10.19 217 73296 59448 29441566
Urinary tract infection 13.90 10.19 114 73399 72240 29428774
Sciatic nerve palsy 13.90 10.19 5 73508 42 29500972
Drug resistance 13.86 10.19 20 73493 21520 29479494
Hyperkalaemia 13.85 10.19 222 73291 61170 29439844
Shock symptom 13.83 10.19 6 73507 86 29500928
Oligohydramnios 13.81 10.19 9 73504 304 29500710
Transplant rejection 13.80 10.19 3 73510 9209 29491805
Encephalopathy 13.73 10.19 36 73477 31007 29470007
Laryngeal discomfort 13.64 10.19 7 73506 149 29500865
Skin necrosis 13.62 10.19 35 73478 4977 29496037
Rash erythematous 13.56 10.19 96 73417 21466 29479548
Costovertebral angle tenderness 13.53 10.19 6 73507 91 29500923
Tonsil cancer 13.52 10.19 14 73499 917 29500097
Skin erosion 13.48 10.19 19 73494 1717 29499297
Deafness congenital 13.47 10.19 6 73507 92 29500922
Pyoderma gangrenosum 13.39 10.19 15 73498 1074 29499940
Intestinal metastasis 13.35 10.19 7 73506 156 29500858
Musculoskeletal pain 13.34 10.19 120 73393 28833 29472181
Xanthelasma 13.29 10.19 6 73507 95 29500919
Lentigo maligna 13.26 10.19 9 73504 326 29500688
Craniocerebral injury 13.24 10.19 24 73489 2684 29498330
Ductus arteriosus stenosis foetal 13.24 10.19 6 73507 96 29500918
Duodenal obstruction 13.23 10.19 7 73506 159 29500855
Soft tissue infection 13.21 10.19 19 73494 1750 29499264
Cardiogenic shock 13.17 10.19 17 73496 19173 29481841
White blood cell count decreased 13.15 10.19 138 73375 83224 29417790
Cold sweat 13.08 10.19 50 73463 8792 29492222
Tachycardia 13.06 10.19 116 73397 72294 29428720
Endoscopy abnormal 13.05 10.19 4 73509 19 29500995
Gastric disorder 13.04 10.19 57 73456 10647 29490367
Ocular hyperaemia 13.00 10.19 51 73462 9076 29491938
Dactylitis 13.00 10.19 12 73501 682 29500332
Central nervous system inflammation 12.96 10.19 6 73507 101 29500913
Oculomucocutaneous syndrome 12.96 10.19 7 73506 166 29500848
Peritonsillitis 12.93 10.19 3 73510 3 29501011
Diarrhoea 12.90 10.19 686 72827 332012 29169002
Application site exfoliation 12.86 10.19 6 73507 103 29500911
Acquired haemophilia 12.82 10.19 13 73500 830 29500184
Eye pain 12.82 10.19 60 73453 11535 29489479
Linear IgA disease 12.80 10.19 17 73496 1452 29499562
Thrombosis mesenteric vessel 12.79 10.19 5 73508 54 29500960
Noninfective gingivitis 12.77 10.19 8 73505 252 29500762
Hepatic mass 12.74 10.19 14 73499 981 29500033
Gastric bypass 12.61 10.19 8 73505 258 29500756
Dehydration 12.57 10.19 205 73308 114543 29386471
Stevens-Johnson syndrome 12.53 10.19 77 73436 16420 29484594
Platelet count decreased 12.48 10.19 184 73329 104488 29396526
Laryngeal oedema 12.42 10.19 25 73488 3023 29497991
Double stranded DNA antibody positive 12.38 10.19 7 73506 182 29500832
Physical examination abnormal 12.36 10.19 8 73505 267 29500747
Bradycardia 12.34 10.19 104 73409 65525 29435489
Aggression 12.34 10.19 46 73467 35495 29465519
Ecthyma 12.30 10.19 9 73504 368 29500646
Prurigo 12.22 10.19 11 73502 605 29500409
Fixed eruption 12.19 10.19 15 73498 1187 29499827
Unevaluable event 12.17 10.19 36 73477 29815 29471199
Musculoskeletal discomfort 12.10 10.19 39 73474 6302 29494712
Tumour invasion 12.05 10.19 8 73505 279 29500735
Pneumonitis 12.04 10.19 33 73480 28011 29473003
Eye swelling 12.03 10.19 48 73465 8609 29492405
Anxiety 12.01 10.19 145 73368 85220 29415794
Slow speech 11.93 10.19 13 73500 903 29500111
Small intestine carcinoma 11.89 10.19 10 73503 502 29500512
Skin lesion 11.86 10.19 83 73430 18489 29482525
Skin graft 11.85 10.19 10 73503 504 29500510
Orthostatic hypotension 11.81 10.19 24 73489 22605 29478409
Delirium 11.80 10.19 54 73459 39343 29461671
Dermatosis 11.75 10.19 8 73505 291 29500723
Ventricular tachycardia 11.74 10.19 24 73489 22550 29478464
Oral herpes 11.65 10.19 31 73482 4501 29496513
Stomatitis 11.64 10.19 50 73463 37063 29463951
Megacolon 11.63 10.19 17 73496 1588 29499426
Post procedural infection 11.63 10.19 30 73483 4275 29496739
Saccadic eye movement 11.60 10.19 6 73507 130 29500884
Terminal insomnia 11.59 10.19 9 73504 403 29500611
Myofascial pain syndrome 11.49 10.19 8 73505 302 29500712
Metastases to heart 11.47 10.19 6 73507 133 29500881
Pyomyositis 11.47 10.19 6 73507 133 29500881
Exposure to communicable disease 11.43 10.19 6 73507 134 29500880
Intestinal transit time decreased 11.41 10.19 3 73510 7 29501007
Lipid metabolism disorder 11.40 10.19 8 73505 306 29500708
Ulcer 11.37 10.19 41 73472 7010 29494004
Head discomfort 11.36 10.19 25 73488 3217 29497797
Duodenitis 11.36 10.19 29 73484 4106 29496908
Small intestine ulcer 11.32 10.19 9 73504 417 29500597
Product prescribing error 11.29 10.19 80 73433 17896 29483118
Large intestine perforation 11.22 10.19 42 73471 7314 29493700
Corneal infiltrates 11.16 10.19 6 73507 141 29500873
Axillary pain 11.15 10.19 8 73505 317 29500697
Nightmare 11.14 10.19 57 73456 11360 29489654
Ascites 11.08 10.19 50 73463 36569 29464445
Renal infarct 11.03 10.19 14 73499 1143 29499871
Right ventricular failure 10.98 10.19 3 73510 7887 29493127
Infusion related reaction 10.97 10.19 64 73449 43822 29457192
Gastrointestinal wall thickening 10.93 10.19 14 73499 1154 29499860
Drug reaction with eosinophilia and systemic symptoms 10.91 10.19 112 73401 27880 29473134
Metastases to peritoneum 10.87 10.19 16 73497 1504 29499510
Hyperglycaemia 10.87 10.19 46 73467 34241 29466773
Ileal perforation 10.87 10.19 11 73502 701 29500313
Hip surgery 10.86 10.19 12 73501 846 29500168
Pain in extremity 10.84 10.19 355 73158 110078 29390936
Suicide attempt 10.79 10.19 131 73382 33979 29467035
Metatarsalgia 10.76 10.19 5 73508 85 29500929
Postictal paralysis 10.76 10.19 7 73506 236 29500778
Skull fractured base 10.75 10.19 6 73507 152 29500862
Drug abuse 10.75 10.19 137 73376 79746 29421268
Obstruction gastric 10.73 10.19 12 73501 858 29500156
Ejection fraction 10.71 10.19 5 73508 86 29500928
Laboratory test abnormal 10.63 10.19 18 73495 18167 29482847
Duodenal ulcer repair 10.63 10.19 3 73510 10 29501004
Cough 10.61 10.19 237 73276 126490 29374524
Discoloured vomit 10.61 10.19 9 73504 457 29500557
Drug intolerance 10.56 10.19 174 73339 48205 29452809
Vomiting 10.52 10.19 636 72877 211624 29289390
Pancreatitis 10.52 10.19 47 73466 34467 29466547
Hypoproteinaemia 10.51 10.19 17 73496 1735 29499279
Application site dermatitis 10.51 10.19 4 73509 40 29500974
No adverse event 10.50 10.19 17 73496 17461 29483553
Angular cheilitis 10.48 10.19 6 73507 160 29500854
Scrotal ulcer 10.40 10.19 8 73505 353 29500661
Hyperventilation 10.39 10.19 20 73493 2342 29498672
Nail bed inflammation 10.34 10.19 6 73507 164 29500850
Rash 10.22 10.19 573 72940 189246 29311768
Hyponatriuria 10.20 10.19 3 73510 12 29501002

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 1181.37 9.95 1229 216198 59472 64221833
Systemic lupus erythematosus 1041.83 9.95 1296 216131 76316 64204989
Glossodynia 992.10 9.95 1156 216271 63540 64217765
Hand deformity 973.24 9.95 1128 216299 61643 64219662
Embolia cutis medicamentosa 964.22 9.95 242 217185 253 64281052
Pericarditis 945.18 9.95 1109 216318 61407 64219898
Anti-cyclic citrullinated peptide antibody positive 887.08 9.95 960 216467 48602 64232703
Wound 826.25 9.95 1148 216279 75329 64205976
Rheumatoid arthritis 763.44 9.95 1700 215727 162594 64118711
Discomfort 746.71 9.95 1127 216300 79751 64201554
Duodenal ulcer perforation 736.90 9.95 736 216691 33889 64247416
Arthropathy 671.15 9.95 1346 216081 119621 64161684
Synovitis 617.23 9.95 1158 216269 97932 64183373
Abdominal discomfort 596.53 9.95 1650 215777 180672 64100633
Helicobacter infection 595.38 9.95 690 216737 37672 64243633
Swelling 568.28 9.95 1494 215933 158724 64122581
Alopecia 560.39 9.95 1518 215909 164172 64117133
Death 507.73 9.95 528 216899 482177 63799128
Joint swelling 483.11 9.95 1710 215717 213672 64067633
Maternal exposure during pregnancy 443.53 9.95 991 216436 94893 64186412
Contraindicated product administered 438.02 9.95 1059 216368 106770 64174535
Hypersensitivity 422.79 9.95 1539 215888 194913 64086392
Hepatic enzyme increased 399.20 9.95 1150 216277 128793 64152512
Rheumatoid factor positive 394.40 9.95 536 216891 34402 64246903
Blister 373.47 9.95 836 216591 80131 64201174
Muscle injury 361.62 9.95 446 216981 25991 64255314
Drug intolerance 347.93 9.95 1404 216023 186588 64094717
Irritable bowel syndrome 329.47 9.95 510 216917 36859 64244446
Folliculitis 325.28 9.95 452 216975 29625 64251680
Febrile neutropenia 313.72 9.95 120 217307 187537 64093768
Infusion related reaction 309.60 9.95 1235 216192 163232 64118073
Sleep disorder due to general medical condition, insomnia type 307.13 9.95 410 217017 25860 64255445
Pain 280.18 9.95 2972 214455 550539 63730766
Neutropenia 270.02 9.95 246 217181 239378 64041927
Melaena 262.82 9.95 567 216860 52981 64228324
Gastric ulcer 257.29 9.95 406 217021 29828 64251477
Therapeutic product effect decreased 252.35 9.95 909 216518 114442 64166863
Gastrointestinal disorder 225.95 9.95 741 216686 88968 64192337
Impaired healing 220.25 9.95 570 216857 59903 64221402
Completed suicide 209.91 9.95 269 217158 224145 64057160
Ankylosing spondylitis 197.54 9.95 187 217240 8047 64273258
Off label use 194.99 9.95 1292 216135 631514 63649791
Toxicity to various agents 192.88 9.95 607 216820 362906 63918399
Pneumonia 189.13 9.95 1110 216317 558466 63722839
Musculoskeletal stiffness 175.22 9.95 851 216576 122355 64158950
Duodenal ulcer 171.33 9.95 227 217200 14208 64267097
Hip arthroplasty 161.69 9.95 272 217155 21079 64260226
Arthralgia 160.84 9.95 2232 215195 440028 63841277
Thrombocytopenia 154.48 9.95 327 217100 223474 64057831
Gastric ulcer perforation 151.07 9.95 87 217340 1706 64279599
Rheumatic fever 150.58 9.95 171 217256 9123 64272182
Cardiac failure congestive 149.43 9.95 132 217295 130448 64150857
Large intestinal stenosis 148.24 9.95 96 217331 2341 64278964
Rash 145.01 9.95 2259 215168 456290 63825015
Swollen joint count increased 135.80 9.95 148 217279 7541 64273764
Anaphylactic shock 132.90 9.95 307 217120 30021 64251284
Atrial fibrillation 132.84 9.95 233 217194 170856 64110449
Hypotension 127.25 9.95 758 216669 380216 63901089
Disease progression 127.12 9.95 175 217252 141505 64139800
Product use issue 126.17 9.95 910 216517 150805 64130500
Knee arthroplasty 125.75 9.95 280 217147 26719 64254586
Angioedema 124.07 9.95 474 216953 61347 64219958
Intestinal diaphragm disease 123.69 9.95 46 217381 304 64281001
Treatment failure 121.52 9.95 741 216686 116075 64165230
Psoriatic arthropathy 118.47 9.95 368 217059 42913 64238392
Pruritus 114.72 9.95 1580 215847 310820 63970485
Diarrhoea 112.76 9.95 1737 215690 720967 63560338
Large intestinal ulcer 111.77 9.95 101 217326 4092 64277213
Sepsis 108.19 9.95 405 217022 229936 64051369
Electrocardiogram QT prolonged 108.08 9.95 67 217360 79381 64201924
Gastritis erosive 107.93 9.95 147 217280 9448 64271857
Anaphylactic reaction 103.90 9.95 483 216944 68181 64213124
Pancytopenia 102.55 9.95 205 217222 143104 64138201
Ill-defined disorder 98.67 9.95 350 217077 43702 64237603
Grip strength decreased 89.62 9.95 150 217277 11574 64269731
Cough 89.16 9.95 624 216803 301524 63979781
Product dose omission issue 87.84 9.95 348 217079 194399 64086906
Kounis syndrome 86.86 9.95 76 217351 2949 64278356
Lower respiratory tract infection 84.75 9.95 578 216849 94036 64187269
Cerebrovascular accident 82.88 9.95 216 217211 137367 64143938
Stomatitis 80.15 9.95 638 216789 108967 64172338
Platelet count decreased 76.05 9.95 299 217128 167412 64113893
Seizure 74.12 9.95 300 217127 166592 64114713
Dehydration 71.86 9.95 432 216995 216331 64064974
Gastric ulcer haemorrhage 71.55 9.95 111 217316 8032 64273273
Hospitalisation 71.42 9.95 89 217338 75118 64206187
Osteoarthritis 71.12 9.95 410 217017 62926 64218379
Deafness transitory 69.52 9.95 40 217387 783 64280522
Cardio-respiratory arrest 69.30 9.95 142 217285 98251 64183054
Leukopenia 68.89 9.95 149 217278 101093 64180212
Cytomegalovirus infection 68.71 9.95 20 217407 37179 64244126
Cardiac arrest 67.75 9.95 278 217149 153786 64127519
Hypokalaemia 67.74 9.95 199 217228 121704 64159601
Contusion 67.42 9.95 633 216794 113332 64167973
Plasma cell myeloma 66.72 9.95 36 217391 46039 64235266
Injection site necrosis 65.74 9.95 46 217381 1279 64280026
Periorbital oedema 65.06 9.95 101 217326 7313 64273992
White blood cell count decreased 63.21 9.95 295 217132 157542 64123763
Neutrophil count decreased 61.82 9.95 103 217324 77093 64204212
Type I hypersensitivity 61.74 9.95 68 217359 3506 64277799
Hypoxia 61.42 9.95 128 217299 88021 64193284
Drug abuse 61.29 9.95 234 217193 132140 64149165
Constipation 61.23 9.95 487 216940 228850 64052455
Sacroiliitis 60.34 9.95 62 217365 2950 64278355
Aspirin-exacerbated respiratory disease 59.26 9.95 41 217386 1119 64280186
Gastrointestinal erosion 58.05 9.95 38 217389 944 64280361
Respiratory failure 57.84 9.95 313 217114 160870 64120435
Hypoglycaemia 57.34 9.95 137 217290 89755 64191550
Bradycardia 57.33 9.95 205 217222 118014 64163291
Type 2 diabetes mellitus 57.23 9.95 247 217180 33773 64247532
Peripheral swelling 57.21 9.95 1007 216420 208146 64073159
Malignant neoplasm progression 55.89 9.95 194 217233 112677 64168628
Blood cholesterol increased 55.49 9.95 323 217104 49743 64231562
Mental status changes 54.37 9.95 76 217351 61086 64220219
Pulmonary embolism 54.30 9.95 281 217146 146075 64135230
Gastric haemorrhage 54.21 9.95 132 217295 13349 64267956
Abdominal pain upper 53.83 9.95 859 216568 174171 64107134
Haematemesis 53.25 9.95 305 217122 46694 64234611
Hypomagnesaemia 52.97 9.95 30 217397 37346 64243959
Urticaria 51.89 9.95 740 216687 146577 64134728
Cardiac failure 50.90 9.95 251 217176 132122 64149183
Seronegative arthritis 50.55 9.95 54 217373 2689 64278616
Cognitive disorder 50.43 9.95 67 217360 55020 64226285
Device expulsion 50.41 9.95 6 217421 21130 64260175
Spinal pain 50.14 9.95 123 217304 12498 64268807
Neuropathy peripheral 49.84 9.95 215 217212 117310 64163995
Oligohydramnios 49.79 9.95 57 217370 3067 64278238
Joint dislocation 49.06 9.95 115 217312 11350 64269955
Neuroleptic malignant syndrome 48.89 9.95 12 217415 24984 64256321
Anxiety 48.40 9.95 443 216984 202206 64079099
Nasopharyngitis 48.37 9.95 929 216498 195144 64086161
Oxygen saturation decreased 47.98 9.95 192 217235 106984 64174321
Sinusitis 47.08 9.95 722 216705 145206 64136099
Corneal epithelium defect 46.69 9.95 29 217398 656 64280649
Neurotoxicity 46.62 9.95 17 217410 27387 64253918
Nausea 46.51 9.95 2171 215256 783629 63497676
Epistaxis 46.37 9.95 172 217255 97959 64183346
Pleural effusion 45.82 9.95 245 217182 126314 64154991
Live birth 45.37 9.95 110 217317 11094 64270211
Acute myeloid leukaemia 45.11 9.95 18 217409 27445 64253860
Infection 44.93 9.95 874 216553 184006 64097299
Cytokine release syndrome 44.85 9.95 8 217419 20821 64260484
Tachycardia 44.50 9.95 308 217119 149271 64132034
Myocardial infarction 44.29 9.95 352 217075 165469 64115836
Small intestine ulcer 44.07 9.95 28 217399 660 64280645
Intestinal ulcer 44.05 9.95 40 217387 1631 64279674
Urinary tract infection 44.04 9.95 534 216893 231062 64050243
Fluid retention 43.70 9.95 84 217343 59522 64221783
Ulcerative keratitis 43.55 9.95 53 217374 3044 64278261
Fat necrosis 43.42 9.95 29 217398 746 64280559
Ascites 43.21 9.95 90 217337 61911 64219394
Endoscopy abnormal 42.91 9.95 13 217414 40 64281265
Tubulointerstitial nephritis 42.81 9.95 212 217215 30697 64250608
COVID-19 42.56 9.95 98 217329 65042 64216263
Upper gastrointestinal haemorrhage 42.18 9.95 232 217195 34988 64246317
Fall 41.95 9.95 1077 216350 415749 63865556
Peptic ulcer 41.50 9.95 69 217358 5294 64276011
Spinal stenosis 41.45 9.95 122 217305 13809 64267496
Ileal ulcer 40.94 9.95 31 217396 977 64280328
Keratopathy 40.86 9.95 28 217399 752 64280553
Shoulder arthroplasty 40.79 9.95 48 217379 2661 64278644
Pancreatitis 40.31 9.95 88 217339 59519 64221786
Posterior reversible encephalopathy syndrome 39.43 9.95 14 217413 22932 64258373
Duodenal ulcer haemorrhage 39.41 9.95 74 217353 6251 64275054
Fibromyalgia 39.25 9.95 230 217197 35501 64245804
Bacteraemia 39.00 9.95 21 217406 26890 64254415
Transplant rejection 38.99 9.95 6 217421 17395 64263910
Clostridium difficile infection 38.47 9.95 39 217388 36124 64245181
Neoplasm progression 38.34 9.95 49 217378 40915 64240390
Porphyria acute 38.08 9.95 26 217401 694 64280611
Red blood cell sedimentation rate abnormal 37.99 9.95 5 217422 16301 64265004
Mucosal inflammation 37.86 9.95 98 217329 62486 64218819
Peritonitis 37.82 9.95 176 217251 24847 64256458
Maternal exposure timing unspecified 37.54 9.95 46 217381 2661 64278644
Tonsillar ulcer 37.10 9.95 21 217406 398 64280907
Application site rash 36.95 9.95 39 217388 1915 64279390
Gastrointestinal pain 35.77 9.95 79 217348 7495 64273810
Encephalopathy 35.66 9.95 92 217335 58727 64222578
Bone marrow failure 35.66 9.95 67 217360 47885 64233420
Ear infection 35.65 9.95 165 217262 23239 64258066
Hypervolaemia 35.62 9.95 46 217381 38239 64243066
Septic shock 35.50 9.95 209 217218 105228 64176077
Deep vein thrombosis 35.15 9.95 209 217218 104973 64176332
Aggression 34.91 9.95 64 217363 46168 64235137
Agitation 34.86 9.95 166 217261 88201 64193104
Thrombotic microangiopathy 34.58 9.95 7 217420 16648 64264657
Large intestine perforation 34.32 9.95 107 217320 12497 64268808
Renal failure neonatal 34.11 9.95 12 217415 66 64281239
Ductus arteriosus stenosis foetal 33.96 9.95 12 217415 67 64281238
Ligament calcification 33.82 9.95 16 217411 205 64281100
Pulmonary arterial hypertension 33.65 9.95 22 217405 25345 64255960
Asthenia 33.57 9.95 1144 216283 426900 63854405
Blood glucose increased 33.23 9.95 194 217233 97879 64183426
Ventricular tachycardia 33.10 9.95 40 217387 34225 64247080
Tenderness 32.72 9.95 142 217285 19460 64261845
Drug ineffective 32.47 9.95 3269 214158 836978 63444327
Haematotoxicity 32.46 9.95 3 217424 12893 64268412
Respiratory distress 32.38 9.95 81 217346 52250 64229055
Right ventricular failure 32.24 9.95 16 217411 21455 64259850
Hyperglycaemia 32.09 9.95 102 217325 60866 64220439
Mucosal erosion 32.04 9.95 36 217391 1898 64279407
Corneal thinning 31.80 9.95 14 217413 150 64281155
Diabetes mellitus 31.73 9.95 116 217311 66358 64214947
Gastrointestinal ulcer 31.44 9.95 45 217382 3030 64278275
Conjunctival hyperaemia 31.30 9.95 51 217376 3848 64277457
Gastritis 31.08 9.95 248 217179 42370 64238935
Hypercalcaemia 31.07 9.95 36 217391 31380 64249925
Torsade de pointes 30.87 9.95 10 217417 17353 64263952
Drug resistance 30.81 9.95 44 217383 35058 64246247
Functional gastrointestinal disorder 30.44 9.95 52 217375 4079 64277226
Lymphocyte stimulation test positive 30.19 9.95 27 217400 1079 64280226
Unevaluable event 29.82 9.95 80 217347 50409 64230896
Glomerulonephritis minimal lesion 29.67 9.95 22 217405 671 64280634
Pharyngitis 29.57 9.95 135 217292 18904 64262401
Inflammatory bowel disease 29.41 9.95 54 217373 4484 64276821
Ejection fraction decreased 29.37 9.95 32 217395 28675 64252630
Application site eczema 29.12 9.95 7 217420 5 64281300
Pericardial effusion 29.05 9.95 55 217372 39199 64242106
Neonatal respiratory acidosis 29.05 9.95 10 217417 51 64281254
Balance disorder 28.98 9.95 165 217262 83761 64197544
Enterococcal infection 28.43 9.95 6 217421 13860 64267445
Dislocation of vertebra 28.03 9.95 43 217384 3081 64278224
Necrotising fasciitis 27.97 9.95 58 217369 5268 64276037
Chronic obstructive pulmonary disease 27.71 9.95 134 217293 70914 64210391
Bronchopulmonary aspergillosis 27.50 9.95 15 217412 19070 64262235
Hallucination 27.40 9.95 139 217288 72649 64208656
Cytopenia 27.35 9.95 9 217418 15462 64265843
Myelosuppression 27.34 9.95 24 217403 23806 64257499
Microcytic anaemia 27.34 9.95 53 217374 4585 64276720
Febrile bone marrow aplasia 27.33 9.95 3 217424 11252 64270053
Neutropenic sepsis 27.24 9.95 23 217404 23249 64258056
Drug hypersensitivity 27.21 9.95 1019 216408 236796 64044509
Soft tissue injury 27.20 9.95 30 217397 1549 64279756
Progressive multifocal leukoencephalopathy 26.76 9.95 14 217413 18218 64263087
Adjustment disorder with depressed mood 26.67 9.95 37 217390 2420 64278885
Pneumonia aspiration 26.63 9.95 106 217321 59165 64222140
Gastrointestinal haemorrhage 26.44 9.95 608 216819 131704 64149601
Bradycardia neonatal 26.40 9.95 10 217417 70 64281235
Hypocalcaemia 26.33 9.95 64 217363 41689 64239616
Analgesic drug level above therapeutic 26.16 9.95 17 217410 417 64280888
Transfusion 26.14 9.95 14 217413 17980 64263325
Jejunal ulcer perforation 25.92 9.95 11 217416 107 64281198
General physical health deterioration 25.86 9.95 886 216541 203539 64077766
Lymphatic fistula 25.79 9.95 21 217406 737 64280568
Tissue infiltration 25.78 9.95 19 217408 574 64280731
Metastases to stomach 25.77 9.95 14 217413 244 64281061
Mastoid abscess 25.75 9.95 6 217421 3 64281302
Femoral hernia incarcerated 25.72 9.95 21 217406 740 64280565
Akathisia 25.72 9.95 4 217423 11506 64269799
Cyanosis neonatal 25.66 9.95 9 217418 49 64281256
Iris hypopigmentation 25.51 9.95 9 217418 50 64281255
Device related infection 25.32 9.95 40 217387 30586 64250719
Underdose 25.11 9.95 30 217397 25799 64255506
Rotator cuff repair 25.00 9.95 28 217399 1471 64279834
Nephrotic syndrome 24.94 9.95 80 217347 9487 64271818
Aspergillus infection 24.90 9.95 12 217415 16367 64264938
Dyspnoea 24.82 9.95 2086 215341 716588 63564717
Orthostatic hypotension 24.73 9.95 78 217349 46660 64234645
Schizophrenia 24.68 9.95 4 217423 11164 64270141
Tubulointerstitial nephritis and uveitis syndrome 24.51 9.95 14 217413 270 64281035
Full blood count abnormal 24.48 9.95 39 217388 29718 64251587
Tongue oedema 24.46 9.95 59 217368 5931 64275374
Infective pulmonary exacerbation of cystic fibrosis 24.40 9.95 5 217422 11791 64269514
Muscle swelling 24.37 9.95 20 217407 710 64280595
Immune reconstitution inflammatory syndrome 24.36 9.95 6 217421 12464 64268841
Orbital oedema 24.11 9.95 14 217413 279 64281026
Wrist deformity 24.02 9.95 30 217397 1770 64279535
Blood lactate dehydrogenase increased 23.86 9.95 192 217235 32886 64248419
C-reactive protein increased 23.82 9.95 451 216976 94458 64186847
Diabetic ketoacidosis 23.72 9.95 40 217387 29805 64251500
Generalised tonic-clonic seizure 23.66 9.95 63 217364 39794 64241511
Jaundice 23.64 9.95 259 217168 48253 64233052
Hypernatraemia 23.55 9.95 6 217421 12183 64269122
Retinitis 23.53 9.95 32 217395 2053 64279252
Device dislocation 23.50 9.95 22 217405 21156 64260149
Rheumatoid lung 23.49 9.95 35 217392 2444 64278861
Anuria 23.43 9.95 126 217301 18838 64262467
Wrong technique in product usage process 23.38 9.95 126 217301 64848 64216457
Punctate keratitis 23.38 9.95 21 217406 844 64280461
Paranoia 23.35 9.95 13 217414 16339 64264966
Linear IgA disease 23.24 9.95 37 217390 2737 64278568
Atelectasis 23.13 9.95 35 217392 27231 64254074
Soft tissue infection 23.00 9.95 40 217387 3183 64278122
Dyspnoea exertional 22.82 9.95 150 217277 73580 64207725
Unresponsive to stimuli 22.72 9.95 90 217337 50303 64231002
Application site reaction 22.64 9.95 19 217408 696 64280609
Arteriovenous fistula occlusion 22.55 9.95 17 217410 532 64280773
Respiratory arrest 22.41 9.95 97 217330 52888 64228417
Incorrect dose administered 22.33 9.95 117 217310 60648 64220657
Status epilepticus 22.33 9.95 24 217403 21639 64259666
Renal tubular necrosis 22.17 9.95 139 217288 21971 64259334
Face oedema 21.99 9.95 151 217276 24610 64256695
Hepatic failure 21.88 9.95 104 217323 55290 64226015
Hypochromic anaemia 21.82 9.95 33 217394 2335 64278970
Blue toe syndrome 21.77 9.95 17 217410 561 64280744
Faeces discoloured 21.74 9.95 155 217272 25574 64255731
Neck pain 21.61 9.95 309 217118 61224 64220081
Lower respiratory tract infection viral 21.60 9.95 21 217406 934 64280371
Iron deficiency anaemia 21.57 9.95 137 217290 21752 64259553
Synovial cyst 21.52 9.95 66 217361 7641 64273664
Malignant mesenteric neoplasm 21.50 9.95 8 217419 53 64281252
Depression 21.33 9.95 463 216964 182828 64098477
Anaemia 21.14 9.95 1052 216375 377628 63903677
Application site erythema 21.13 9.95 48 217379 4641 64276664
Heart rate increased 20.89 9.95 222 217205 98453 64182852
Erosive duodenitis 20.86 9.95 27 217400 1651 64279654
Lymphocyte count decreased 20.78 9.95 69 217358 40630 64240675
Pancreatic steatosis 20.65 9.95 21 217406 987 64280318
Small intestine carcinoma 20.63 9.95 19 217408 789 64280516
Diabetes mellitus inadequate control 20.48 9.95 25 217402 21296 64260009
Acquired porphyria 20.45 9.95 7 217420 35 64281270
Second primary malignancy 20.40 9.95 8 217419 12329 64268976
Jejunal ulcer 20.39 9.95 11 217416 189 64281116
Eschar 20.37 9.95 22 217405 1109 64280196
Hypoproteinaemia 20.37 9.95 39 217388 3343 64277962
Multiple organ dysfunction syndrome 20.34 9.95 231 217196 101182 64180123
Frequent bowel movements 20.33 9.95 19 217408 18286 64263019
Adverse event 20.25 9.95 213 217214 39276 64242029
Cardiogenic shock 20.21 9.95 50 217377 32377 64248928
Staphylococcal bacteraemia 20.19 9.95 5 217422 10350 64270955
Lip ulceration 20.04 9.95 29 217398 1972 64279333
Hypoaldosteronism 20.04 9.95 13 217414 318 64280987
Hypoaesthesia 19.94 9.95 612 216815 138496 64142809
Sleep disorder 19.84 9.95 297 217130 59412 64221893
Coma 19.84 9.95 194 217233 87421 64193884
Myocarditis 19.76 9.95 17 217410 17026 64264279
Gallbladder adenocarcinoma 19.54 9.95 9 217418 108 64281197
Psychotic disorder 19.52 9.95 56 217371 34522 64246783
Feeding disorder 19.51 9.95 91 217336 12858 64268447
Musculoskeletal disorder 19.50 9.95 115 217312 17791 64263514
Multiple sclerosis relapse 19.49 9.95 72 217355 41063 64240242
Pyloric stenosis 19.47 9.95 14 217413 407 64280898
Spinal fusion surgery 19.46 9.95 40 217387 3611 64277694
Body mass index abnormal 19.45 9.95 11 217416 208 64281097
Haematochezia 19.36 9.95 323 217104 66050 64215255
Application site ulcer 19.33 9.95 9 217418 111 64281194
Oral pruritus 19.32 9.95 27 217400 1778 64279527
Device issue 19.28 9.95 29 217398 22619 64258686
Spondyloarthropathy 19.14 9.95 18 217409 768 64280537
Hyponatraemia 18.95 9.95 369 217058 147970 64133335
Product administered at inappropriate site 18.90 9.95 36 217391 3074 64278231
Complication associated with device 18.79 9.95 14 217413 15066 64266239
Urine porphobilinogen increased 18.78 9.95 4 217423 0 64281305
Aplasia cutis congenita 18.78 9.95 4 217423 0 64281305
Pyrexia 18.73 9.95 1625 215802 557019 63724286
Fibrosis 18.70 9.95 46 217381 4682 64276623
Drug tolerance decreased 18.68 9.95 59 217368 6939 64274366
Neonatal respiratory distress syndrome 18.65 9.95 11 217416 226 64281079
Granulocytopenia 18.58 9.95 6 217421 10434 64270871
Hyperventilation 18.56 9.95 58 217369 6782 64274523
Dry skin 18.53 9.95 99 217328 51062 64230243
Creutzfeldt-Jakob disease 18.53 9.95 10 217417 172 64281133
Pneumocystis jirovecii pneumonia 18.51 9.95 41 217386 27593 64253712
Muscle tone disorder 18.51 9.95 9 217418 123 64281182
Obstructive airways disorder 18.50 9.95 31 217396 23154 64258151
Acute graft versus host disease 18.48 9.95 4 217423 9080 64272225
Failure to thrive 18.48 9.95 6 217421 10398 64270907
Anterior chamber cell 18.42 9.95 18 217409 806 64280499
Joint range of motion decreased 18.41 9.95 120 217307 19223 64262082
Inflammation 18.39 9.95 316 217111 64984 64216321
Angiocardiogram 18.39 9.95 11 217416 232 64281073
Intestinal congestion 18.36 9.95 5 217422 9 64281296
Sedation complication 18.34 9.95 6 217421 10348 64270957
Weight decreased 18.31 9.95 782 216645 284957 63996348
Mobility decreased 18.26 9.95 398 217029 85442 64195863
Application site swelling 18.17 9.95 16 217411 626 64280679
Antidepressant drug level above therapeutic 18.17 9.95 15 217412 537 64280768
Cellulitis 18.14 9.95 215 217212 93442 64187863
Urosepsis 18.13 9.95 29 217398 22065 64259240
Lymphopenia 18.08 9.95 37 217390 25620 64255685
Complications of intestinal transplant 18.02 9.95 5 217422 10 64281295
Blood pressure measurement 17.92 9.95 13 217414 383 64280922
Pulmonary oedema 17.90 9.95 174 217253 78500 64202805
Insomnia 17.82 9.95 519 216908 197317 64083988
Abdominal rebound tenderness 17.79 9.95 7 217420 55 64281250
Psoriasis 17.74 9.95 340 217087 71363 64209942
Abnormal loss of weight 17.61 9.95 60 217367 7340 64273965
Laboratory test abnormal 17.56 9.95 34 217393 24029 64257276
Palmar-plantar erythrodysaesthesia syndrome 17.52 9.95 45 217382 28774 64252531
Pallor 17.52 9.95 204 217223 38577 64242728
Porphyria 17.41 9.95 10 217417 195 64281110
Gastritis haemorrhagic 17.37 9.95 29 217398 2233 64279072
Mesenteric neoplasm 17.36 9.95 7 217420 59 64281246
COVID-19 pneumonia 17.33 9.95 18 217409 16486 64264819
Colitis erosive 17.23 9.95 8 217419 98 64281207
Abnormal behaviour 17.17 9.95 57 217370 33565 64247740
Postictal paralysis 17.11 9.95 12 217415 335 64280970
Hyperammonaemia 17.09 9.95 6 217421 9898 64271407
Acquired haemophilia 16.99 9.95 24 217403 1596 64279709
Nerve stimulation test abnormal 16.85 9.95 5 217422 14 64281291
Exposure during pregnancy 16.79 9.95 361 217066 77314 64203991
Extrapyramidal disorder 16.68 9.95 25 217402 19527 64261778
Cardiomyopathy 16.68 9.95 38 217389 25318 64255987
Premature delivery 16.62 9.95 23 217404 18566 64262739
Erythematotelangiectatic rosacea 16.60 9.95 5 217422 15 64281290
Libido increased 16.57 9.95 25 217402 1765 64279540
Central pain syndrome 16.57 9.95 11 217416 280 64281025
Platelet dysfunction 16.56 9.95 12 217415 353 64280952
Upper respiratory tract infection 16.54 9.95 161 217266 72624 64208681
Foot operation 16.53 9.95 41 217386 4194 64277111
Eastern Cooperative Oncology Group performance status 16.48 9.95 6 217421 37 64281268
Abdominal tenderness 16.37 9.95 69 217358 9336 64271969
Mast cell activation syndrome 16.33 9.95 12 217415 361 64280944
Peripheral sensory neuropathy 16.31 9.95 9 217418 11369 64269936
Head titubation 16.22 9.95 17 217410 828 64280477
Sciatic nerve injury 16.17 9.95 13 217414 448 64280857
Eyelid oedema 16.14 9.95 83 217344 12196 64269109
Terminal insomnia 16.06 9.95 18 217409 946 64280359
Hepatic encephalopathy 16.05 9.95 29 217398 21037 64260268
Secondary amyloidosis 15.97 9.95 8 217419 117 64281188
Erythema multiforme 15.93 9.95 99 217328 15602 64265703
Shock 15.89 9.95 198 217229 38042 64243263
Pulmonary hypertension 15.89 9.95 83 217344 43056 64238249
Sciatic nerve palsy 15.82 9.95 7 217420 76 64281229
Diverticulum intestinal 15.80 9.95 58 217369 7362 64273943
Dysphagia 15.76 9.95 259 217168 106553 64174752
Acute respiratory failure 15.75 9.95 101 217326 49833 64231472
Injection site bruising 15.74 9.95 66 217361 36307 64244998
Injection site ulcer 15.72 9.95 15 217412 652 64280653
Cardiac massage 15.70 9.95 5 217422 19 64281286
Fixed eruption 15.68 9.95 27 217400 2132 64279173
Viral upper respiratory tract infection 15.67 9.95 62 217365 8153 64273152
Oculomucocutaneous syndrome 15.59 9.95 11 217416 310 64280995
Cardiac disorder 15.58 9.95 117 217310 55699 64225606
No adverse event 15.58 9.95 47 217380 28514 64252791
Application site oedema 15.58 9.95 7 217420 79 64281226
Product quality issue 15.58 9.95 50 217377 29749 64251556
Haemoptysis 15.58 9.95 99 217328 48949 64232356
Haemorrhage intracranial 15.54 9.95 36 217391 23848 64257457
Pregnancy 15.53 9.95 122 217305 20743 64260562
Tumour lysis syndrome 15.50 9.95 26 217401 19414 64261891
Spondylitis 15.50 9.95 33 217394 3053 64278252
Omental necrosis 15.49 9.95 6 217421 45 64281260
Dysarthria 15.43 9.95 127 217300 59279 64222026
Deep vein thrombosis postoperative 15.41 9.95 21 217406 1350 64279955
Salivary hypersecretion 15.41 9.95 11 217416 12102 64269203
Immunodeficiency 15.39 9.95 19 217408 16105 64265200
Labelled drug-drug interaction medication error 15.34 9.95 127 217300 21935 64259370
Tongue disorder 15.33 9.95 11 217416 12069 64269236
Papulopustular rosacea 15.31 9.95 5 217422 21 64281284
Anti-cyclic citrullinated peptide antibody 15.28 9.95 21 217406 1361 64279944
Electrocardiogram QRS complex prolonged 15.28 9.95 6 217421 9238 64272067
Iris transillumination defect 15.22 9.95 8 217419 130 64281175
Suicidal ideation 15.20 9.95 147 217280 66395 64214910
Immunosuppressant drug level increased 15.18 9.95 3 217424 7256 64274049
Pyoderma streptococcal 15.14 9.95 4 217423 6 64281299
Application site injury 15.12 9.95 5 217422 22 64281283
Tardive dyskinesia 15.10 9.95 6 217421 9172 64272133
Wound infection pseudomonas 15.04 9.95 22 217405 1511 64279794
C-reactive protein abnormal 15 9.95 49 217378 28998 64252307
Gastrointestinal mucosal exfoliation 14.96 9.95 9 217418 192 64281113
Intestinal metaplasia 14.94 9.95 5 217422 23 64281282
Factor VIII deficiency 14.85 9.95 8 217419 137 64281168
Blood pressure fluctuation 14.83 9.95 108 217319 51763 64229542
Hypermobility syndrome 14.80 9.95 13 217414 507 64280798
Injection site hyperaesthesia 14.74 9.95 6 217421 52 64281253
Peritonitis bacterial 14.73 9.95 6 217421 9037 64272268
Inflammatory marker increased 14.70 9.95 62 217365 8389 64272916
Emotional distress 14.62 9.95 67 217360 35971 64245334
Vasoconstriction 14.56 9.95 14 217413 614 64280691
Palatal oedema 14.47 9.95 19 217408 1178 64280127
Aplasia pure red cell 14.45 9.95 3 217424 7011 64274294
Respiratory tract congestion 14.45 9.95 20 217407 16145 64265160
Blood urea increased 14.43 9.95 219 217208 43934 64237371
Pulseless electrical activity 14.41 9.95 13 217414 12726 64268579
Application site pain 14.40 9.95 39 217388 4209 64277096
Syncope 14.33 9.95 413 217014 157222 64124083
Hypertension 14.30 9.95 721 216706 258540 64022765
Intestinal haemorrhage 14.27 9.95 46 217381 5468 64275837
Aplasia 14.27 9.95 3 217424 6950 64274355
Intervertebral disc disorder 14.19 9.95 40 217387 4417 64276888
Blood glucose decreased 14.14 9.95 36 217391 23087 64258218
Laryngitis 14.11 9.95 74 217353 10957 64270348
Post-traumatic neck syndrome 14.09 9.95 24 217403 1878 64279427
Internal limiting membrane peeling 14.09 9.95 3 217424 0 64281305
Lip oedema 14.08 9.95 44 217383 5145 64276160
Seroma 14.02 9.95 25 217402 2029 64279276
Porphyrins urine increased 13.99 9.95 5 217422 29 64281276
Movement disorder 13.91 9.95 124 217303 21876 64259429
Atrioventricular block 13.91 9.95 12 217415 12003 64269302
Chest discomfort 13.87 9.95 292 217135 115814 64165491
Gastric mucosal lesion 13.86 9.95 16 217411 869 64280436
Cerebral haemorrhage 13.83 9.95 108 217319 50982 64230323
Abdominal lymphadenopathy 13.81 9.95 18 217409 1108 64280197
Arterial haemorrhage 13.77 9.95 26 217401 2205 64279100
Acute respiratory distress syndrome 13.73 9.95 76 217351 38859 64242446
Mania 13.72 9.95 21 217406 16265 64265040
Acquired diaphragmatic eventration 13.72 9.95 13 217414 560 64280745
Laparotomy 13.72 9.95 10 217417 297 64281008
Unintentional medical device removal 13.63 9.95 3 217424 6731 64274574
Injection site abscess 13.62 9.95 20 217407 1378 64279927
Hypogammaglobulinaemia 13.57 9.95 9 217418 10290 64271015
Flushing 13.57 9.95 185 217242 78463 64202842
Corneal opacity 13.57 9.95 16 217411 889 64280416
Adverse drug reaction 13.53 9.95 222 217205 45242 64236063
Small intestinal ulcer haemorrhage 13.53 9.95 7 217420 110 64281195
Duodenal stenosis 13.49 9.95 14 217413 674 64280631
Analgesic drug level increased 13.45 9.95 26 217401 2244 64279061
Discoloured vomit 13.43 9.95 18 217409 1139 64280166
Sopor 13.35 9.95 53 217374 29608 64251697
Clostridium difficile colitis 13.33 9.95 47 217380 27176 64254129
Meteoropathy 13.28 9.95 4 217423 12 64281293
Oral mucosa erosion 13.26 9.95 22 217405 1685 64279620
Axial spondyloarthritis 13.25 9.95 11 217416 397 64280908
Basal ganglion degeneration 13.25 9.95 11 217416 397 64280908
Throat irritation 13.16 9.95 61 217366 32650 64248655
Tarsal tunnel syndrome 13.14 9.95 12 217415 493 64280812
Sinus disorder 13.13 9.95 23 217404 16885 64264420
Platelet function test abnormal 13.12 9.95 8 217419 175 64281130
Acute kidney injury 13.08 9.95 1717 215710 447523 63833782
Productive cough 13.06 9.95 171 217256 73032 64208273
Application site exfoliation 13.05 9.95 10 217417 321 64280984
Ataxia 13.03 9.95 35 217392 22049 64259256
International normalised ratio increased 13.03 9.95 188 217239 78979 64202326
Candida infection 12.99 9.95 58 217369 31361 64249944
Sinus bradycardia 12.98 9.95 37 217390 22856 64258449
Oesophageal carcinoma recurrent 12.96 9.95 5 217422 37 64281268
Jejunal stenosis 12.88 9.95 6 217421 74 64281231
Sexual dysfunction 12.86 9.95 3 217424 6468 64274837
Psychomotor hyperactivity 12.80 9.95 18 217409 14433 64266872
Subdural haematoma 12.71 9.95 50 217377 28004 64253301
Drug level decreased 12.70 9.95 12 217415 11491 64269814
Bladder cancer 12.65 9.95 11 217416 10963 64270342
Device leakage 12.65 9.95 6 217421 8260 64273045
Inflammatory pain 12.61 9.95 15 217412 841 64280464
Blood potassium decreased 12.59 9.95 82 217345 40317 64240988
Bronchospasm 12.59 9.95 120 217307 21562 64259743
Blood calcium decreased 12.59 9.95 44 217383 25510 64255795
Nodule 12.54 9.95 26 217401 17921 64263384
Peptic ulcer haemorrhage 12.54 9.95 15 217412 846 64280459
Alpha tumour necrosis factor increased 12.52 9.95 5 217422 41 64281264
Cushingoid 12.46 9.95 5 217422 7598 64273707
Respiratory disorder 12.46 9.95 71 217356 36040 64245265
Depressed mood 12.41 9.95 84 217343 40928 64240377
Skin lesion 12.33 9.95 182 217245 36300 64245005
Adrenal insufficiency 12.27 9.95 37 217390 22450 64258855
Bacterial infection 12.26 9.95 43 217384 24907 64256398
Mallory-Weiss syndrome 12.26 9.95 27 217400 2556 64278749
Therapy cessation 12.25 9.95 62 217365 32427 64248878
Porphyrins stool increased 12.22 9.95 5 217422 44 64281261
Exostosis 12.16 9.95 73 217354 11365 64269940
Lethargy 12.08 9.95 172 217255 72422 64208883
Vascular device infection 12.02 9.95 3 217424 6177 64275128
Lentigo maligna 12.02 9.95 11 217416 453 64280852
Leucine aminopeptidase increased 12.02 9.95 3 217424 3 64281302
Small intestinal obstruction 12.01 9.95 40 217387 23533 64257772
Fungal infection 12.00 9.95 67 217360 34184 64247121
Coronary artery disease 11.98 9.95 138 217289 60295 64221010
HLA-B*27 positive 11.96 9.95 6 217421 88 64281217
Myelodysplastic syndrome 11.96 9.95 50 217377 27529 64253776
Ventricular arrhythmia 11.95 9.95 5 217422 7410 64273895
Pulmonary haemorrhage 11.94 9.95 16 217411 13093 64268212
Troponin increased 11.91 9.95 21 217406 15378 64265927
Haemophagocytic lymphohistiocytosis 11.90 9.95 26 217401 17583 64263722
Blood calcium increased 11.90 9.95 7 217420 8535 64272770
Renal failure 11.88 9.95 496 216931 181192 64100113
Fear 11.88 9.95 32 217395 20139 64261166
Cystitis haemorrhagic 11.84 9.95 6 217421 7950 64273355
Persistent corneal epithelial defect 11.84 9.95 5 217422 48 64281257
Urine abnormality 11.81 9.95 5 217422 7357 64273948
Weight increased 11.78 9.95 853 216574 212495 64068810
Lividity 11.74 9.95 10 217417 374 64280931
Gallbladder oedema 11.74 9.95 9 217418 289 64281016
Treatment noncompliance 11.73 9.95 92 217335 43390 64237915
Full blood count decreased 11.73 9.95 38 217389 22544 64258761
Obstruction gastric 11.72 9.95 19 217408 1427 64279878
Injury 11.71 9.95 259 217168 55733 64225572
Corneal oedema 11.71 9.95 25 217402 2318 64278987
Partial seizures 11.66 9.95 5 217422 7302 64274003
Intestinal obstruction 11.65 9.95 73 217354 36213 64245092
Skin graft 11.64 9.95 15 217412 913 64280392
Toxic epidermal necrolysis 11.63 9.95 183 217244 36983 64244322
Cholestasis 11.62 9.95 96 217331 44776 64236529
Pneumonitis 11.62 9.95 111 217316 50254 64231051
Blood test abnormal 11.58 9.95 16 217411 12927 64268378
Respiratory syncytial virus infection 11.56 9.95 5 217422 7263 64274042
Extradural abscess 11.55 9.95 17 217410 1174 64280131
Product prescribing error 11.55 9.95 175 217252 35094 64246211
Basal cell carcinoma 11.54 9.95 59 217368 30779 64250526
Dementia 11.45 9.95 34 217393 20732 64260573
Skin toxicity 11.39 9.95 4 217423 6598 64274707
Panniculitis 11.38 9.95 8 217419 8871 64272434
Neutrophil count increased 11.32 9.95 45 217382 25129 64256176
Central nervous system lesion 11.27 9.95 14 217413 11835 64269470
Wound necrosis 11.26 9.95 12 217415 596 64280709
Loss of personal independence in daily activities 11.25 9.95 174 217253 72280 64209025
Dactylitis 11.25 9.95 22 217405 1916 64279389
Atrial flutter 11.22 9.95 31 217396 19349 64261956
Diffuse large B-cell lymphoma 11.22 9.95 11 217416 10350 64270955
Respiratory acidosis 11.22 9.95 10 217417 9845 64271460
Hyperacusis 11.19 9.95 22 217405 1923 64279382
Episcleritis 11.18 9.95 14 217413 828 64280477
Lithiasis 11.18 9.95 6 217421 102 64281203
Exposure via skin contact 11.17 9.95 7 217420 161 64281144
Lip scab 11.16 9.95 3 217424 5 64281300
Respiratory tract infection 11.12 9.95 77 217350 37330 64243975
Multiple-drug resistance 11.12 9.95 4 217423 6498 64274807
Blood pressure increased 11.09 9.95 472 216955 172080 64109225
Monoplegia 11.06 9.95 31 217396 3412 64277893
Sciatic nerve neuropathy 11.00 9.95 9 217418 318 64280987
Fatigue 10.93 9.95 2761 214666 745969 63535336
Osteonecrosis of jaw 10.87 9.95 84 217343 39741 64241564
Drug level increased 10.87 9.95 69 217358 34127 64247178
Pseudomonas infection 10.81 9.95 28 217399 17855 64263450
Undifferentiated connective tissue disease 10.81 9.95 4 217423 26 64281279
Sebaceous gland infection 10.78 9.95 6 217421 110 64281195
Aortic stenosis 10.74 9.95 4 217423 6361 64274944
Pharyngeal swelling 10.64 9.95 42 217385 5517 64275788
Hypermetropia 10.63 9.95 10 217417 427 64280878
Coronary arterial stent insertion 10.62 9.95 3 217424 5689 64275616
Myoclonus 10.61 9.95 46 217381 25072 64256233
Application site dryness 10.59 9.95 7 217420 177 64281128
Aspiration 10.55 9.95 26 217401 16859 64264446
Cross sensitivity reaction 10.51 9.95 30 217397 3337 64277968
Ciliary hyperaemia 10.50 9.95 5 217422 65 64281240
Renal pain 10.50 9.95 49 217378 6925 64274380
Gingivitis ulcerative 10.49 9.95 8 217419 255 64281050
Intestinal metastasis 10.43 9.95 8 217419 257 64281048
Transaminases increased 10.41 9.95 98 217329 44496 64236809
Hostility 10.40 9.95 23 217404 2184 64279121
Hiatus hernia 10.40 9.95 108 217319 19849 64261456
Parotid gland enlargement 10.39 9.95 13 217414 768 64280537
Uterine enlargement 10.39 9.95 13 217414 768 64280537
Liver injury 10.38 9.95 150 217277 29782 64251523
Neuropathic ulcer 10.37 9.95 5 217422 67 64281238
Bronchitis 10.36 9.95 283 217144 108460 64172845
Tonsillitis 10.36 9.95 43 217384 5777 64275528
Urinoma 10.35 9.95 7 217420 184 64281121
Induced abortion failed 10.35 9.95 7 217420 184 64281121
Duodenal perforation 10.34 9.95 21 217406 1879 64279426
Pneumonia bacterial 10.33 9.95 22 217405 15013 64266292
Arthritis bacterial 10.31 9.95 53 217374 7786 64273519
Pupillary disorder 10.30 9.95 10 217417 444 64280861
Small intestinal stenosis 10.29 9.95 12 217415 659 64280646
Cardiomegaly 10.23 9.95 43 217384 23641 64257664
pH body fluid decreased 10.21 9.95 4 217423 31 64281274
Self-medication 10.21 9.95 34 217393 4111 64277194
Device occlusion 10.20 9.95 11 217416 9902 64271403
Exposure to toxic agent 10.18 9.95 4 217423 6155 64275150
Condition aggravated 10.16 9.95 1418 216009 371008 63910297
Hiccups 10.15 9.95 8 217419 8368 64272937
Hepatotoxicity 10.12 9.95 86 217341 39876 64241429
Sternal fracture 10.12 9.95 23 217404 2224 64279081
Pharyngo-oesophageal diverticulum 10.10 9.95 4 217423 32 64281273
Corneal perforation 10.10 9.95 12 217415 672 64280633
Retinal infarction 10.09 9.95 7 217420 192 64281113
Oral pain 10.06 9.95 53 217374 27440 64253865
Cold sweat 10.02 9.95 92 217335 16363 64264942
Haematocrit decreased 10.00 9.95 127 217300 54528 64226777
Systemic mastocytosis 9.99 9.95 8 217419 274 64281031
Atrioventricular block complete 9.98 9.95 21 217406 14397 64266908
Necrolytic migratory erythema 9.96 9.95 3 217424 9 64281296
Product use in unapproved indication 9.96 9.95 490 216937 176128 64105177

FDA Adverse Event Reporting System (Pediatric)

None

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
Rheumatoid arthritis indication 69896004 DOID:7148
Actinic keratosis indication 201101007 DOID:8866
Dysmenorrhea indication 266599000
Osteoarthritis indication 396275006
Sprains and Strains indication
Analgesia in various types of cancer indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Osteoarthrosis of the Knee indication
Osteoarthritis in Patients at High Ulcer Risk indication
Post-Op Photophobia indication
Post-Op Ocular Inflammation indication
Postoperative Ocular Pain 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
Bloody Vomit contraindication
Uterine Rupture in Pregnancy contraindication
Gynecological Surgery contraindication
Corneal Infiltrates contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Horses Pain and inflammation associated with osteoarthritis Indication

๐Ÿถ 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 ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
18MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 DISCN CAPSULE ORAL 9186328 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 8999387 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX CAPSULE ORAL 9180095 April 23, 2030 TREATMENT OF PAIN
35MG ZORVOLEX ZYLA N204592 Oct. 18, 2013 RX 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

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
DB00586 DRUGBANK_ID
CHEMBL1034 ChEMBL_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 30 sections
ARTHROTEC HUMAN PRESCRIPTION DRUG LABEL 2 0025-1421 TABLET, FILM COATED 75 mg ORAL NDA 30 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 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
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 0228-2551 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
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
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-2170 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 13 sections
Diclofenac sodium HUMAN OTC DRUG LABEL 1 0536-1294 GEL 10 mg TOPICAL ANDA 16 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0397 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 28 sections
Diclofenac Sodium and Misoprostol HUMAN PRESCRIPTION DRUG LABEL 2 0591-0398 TABLET, DELAYED RELEASE 75 mg ORAL ANDA 28 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-803 GEL 30 mg TOPICAL NDA 27 sections
Solaraze HUMAN PRESCRIPTION DRUG LABEL 1 10337-844 GEL 30 mg TOPICAL NDA 26 sections
Diclofenac Sodium HUMAN PRESCRIPTION DRUG LABEL 1 10544-114 TABLET, DELAYED RELEASE 50 mg ORAL ANDA 24 sections