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

Stem definitionDrug idCAS RN
1883 22204-53-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
0.50 g O
0.50 g R
0.50 g O

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
March 11, 1976 FDA ROCHE PALO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pharyngitis 402.36 9.77 406 197385 18132 56076144
C-reactive protein abnormal 374.47 9.77 549 197242 36260 56058016
Red blood cell sedimentation rate abnormal 367.45 9.77 388 197403 18285 56075991
Death 311.81 9.77 448 197343 340978 55753298
Drug hypersensitivity 263.24 9.77 1761 196030 273444 55820832
Deafness transitory 254.11 9.77 128 197663 1814 56092462
Ankylosing spondylitis 244.42 9.77 233 197558 9697 56084579
Gastrointestinal pain 233.42 9.77 215 197576 8562 56085714
Musculoskeletal stiffness 211.60 9.77 1095 196696 154912 55939364
Arthralgia 191.87 9.77 2642 195149 499027 55595249
Drug ineffective 169.24 9.77 4319 193472 914670 55179606
Fibromyalgia 159.87 9.77 517 197274 59086 56035190
Pain in extremity 158.39 9.77 1669 196122 295762 55798514
Psoriatic arthropathy 157.82 9.77 595 197196 73413 56020863
Juvenile idiopathic arthritis 157.14 9.77 132 197659 4641 56089635
Shoulder arthroplasty 157.14 9.77 119 197672 3594 56090682
Synovitis 154.40 9.77 1033 196758 160272 55934004
Rheumatoid nodule 148.74 9.77 220 197571 14637 56079639
Arthritis 148.08 9.77 719 197072 99133 55995143
C-reactive protein increased 147.90 9.77 608 197183 78076 56016200
Impaired work ability 146.21 9.77 216 197575 14356 56079920
Neutropenia 142.65 9.77 209 197582 157958 55936318
Pain 136.73 9.77 3167 194624 660017 55434259
Body height below normal 135.53 9.77 86 197705 1937 56092339
Toothache 127.50 9.77 227 197564 17653 56076623
Pyrexia 124.93 9.77 910 196881 417863 55676413
Human antichimeric antibody positive 123.96 9.77 74 197717 1489 56092787
Polyarthritis 123.61 9.77 153 197638 8575 56085701
Hypoaesthesia 121.18 9.77 882 196909 140609 55953667
Foot operation 121.10 9.77 129 197662 6138 56088138
Joint swelling 121.08 9.77 1552 196239 288248 55806028
Musculoskeletal disorder 120.08 9.77 230 197561 18917 56075359
Anaemia 119.82 9.77 508 197283 267003 55827273
Febrile neutropenia 119.04 9.77 117 197674 105428 55988848
Nerve injury 116.00 9.77 150 197641 8787 56085489
Hyponatraemia 113.16 9.77 115 197676 102024 55992252
Obesity 111.63 9.77 245 197546 22203 56072073
Cardiac failure 111.19 9.77 76 197715 82017 56012259
Maternal exposure during pregnancy 111.03 9.77 321 197470 189232 55905044
Multiple fractures 110.97 9.77 133 197658 7208 56087068
Injury 109.72 9.77 459 197332 59392 56034884
Pancytopenia 108.80 9.77 91 197700 88624 56005652
Gastric ulcer 108.53 9.77 243 197548 22320 56071956
Cholecystitis chronic 107.30 9.77 151 197640 9597 56084679
Exposure during pregnancy 106.32 9.77 198 197593 136144 55958132
Gait inability 106.09 9.77 356 197435 41462 56052814
Femur fracture 105.48 9.77 341 197450 38954 56055322
Pneumonia 104.59 9.77 921 196870 406177 55688099
Joint laxity 102.84 9.77 78 197713 2361 56091915
Inflammation 102.10 9.77 497 197294 68574 56025702
Leukopenia 101.08 9.77 62 197729 70878 56023398
Ear infection 99.34 9.77 288 197503 31007 56063269
Nephrolithiasis 98.42 9.77 322 197469 37013 56057263
Arthropathy 97.74 9.77 1105 196686 199170 55895106
Rheumatoid arthritis 97.26 9.77 1885 195906 380719 55713557
Abdominal pain upper 96.80 9.77 1005 196786 177308 55916968
Joint destruction 95.82 9.77 103 197688 4952 56089324
Musculoskeletal pain 95.32 9.77 548 197243 80604 56013672
Disease progression 94.76 9.77 139 197652 105034 55989242
Dyspnoea 94.11 9.77 1491 196300 591086 55503190
Thrombocytopenia 93.36 9.77 213 197578 136011 55958265
Pemphigus 92.95 9.77 265 197526 156947 55937329
Loose body in joint 92.88 9.77 57 197734 1208 56093068
Sepsis 92.37 9.77 223 197568 139617 55954659
Functional gastrointestinal disorder 87.42 9.77 86 197705 3721 56090555
Osteoporosis 86.82 9.77 388 197403 51664 56042612
Dislocation of vertebra 86.64 9.77 101 197690 5314 56088962
Malignant neoplasm progression 85.97 9.77 79 197712 73508 56020768
Seronegative arthritis 84.62 9.77 73 197718 2663 56091613
Psoriasis 83.48 9.77 585 197206 92107 56002169
Confusional state 83.19 9.77 412 197379 207743 55886533
Drug tolerance 83.16 9.77 104 197687 5890 56088386
Dizziness 81.73 9.77 1811 195980 374329 55719947
Systemic lupus erythematosus rash 81.25 9.77 62 197729 1894 56092382
Cardiac failure congestive 80.93 9.77 114 197677 87606 56006670
Neck pain 77.81 9.77 424 197367 61131 56033145
Wheelchair user 72.92 9.77 93 197698 5373 56088903
Drug interaction 72.36 9.77 436 197355 209319 55884957
Systemic lupus erythematosus 71.61 9.77 357 197434 179721 55914555
Migraine 70.80 9.77 535 197256 86262 56008014
Grip strength decreased 70.40 9.77 168 197623 16088 56078188
Bradycardia 70.30 9.77 80 197711 67424 56026852
Pseudoporphyria 68.46 9.77 26 197765 175 56094101
Dehydration 67.75 9.77 307 197484 158518 55935758
Mobility decreased 67.64 9.77 586 197205 98405 55995871
Red blood cell sedimentation rate increased 66.43 9.77 280 197511 36343 56057933
Enthesopathy 66.21 9.77 109 197682 7954 56086322
Mycotic allergy 62.65 9.77 38 197753 788 56093488
Drug intolerance 61.92 9.77 1289 196502 263529 55830747
Tenosynovitis stenosans 59.93 9.77 59 197732 2555 56091721
Ulcer 59.32 9.77 194 197597 22291 56071985
Glossodynia 59.03 9.77 305 197486 152153 55942123
Foot deformity 58.81 9.77 201 197590 23624 56070652
Respiratory tract congestion 57.93 9.77 152 197639 15439 56078837
Hypotension 57.66 9.77 582 197209 249926 55844350
Bone density decreased 57.57 9.77 134 197657 12626 56081650
Hospitalisation 56.61 9.77 111 197680 74889 56019387
Drug tolerance decreased 56.36 9.77 137 197654 13274 56081002
Antibody test positive 55.98 9.77 55 197736 2376 56091900
Drug abuse 55.54 9.77 95 197696 67515 56026761
Tenosynovitis 55.28 9.77 130 197661 12331 56081945
Adrenal insufficiency 55.25 9.77 150 197641 15547 56078729
Pulmonary arterial hypertension 54.54 9.77 13 197778 26490 56067786
Synovial fluid analysis 54.52 9.77 49 197742 1889 56092387
Renal impairment 53.83 9.77 128 197663 80585 56013691
Platelet count decreased 52.64 9.77 194 197597 106189 55988087
Hypomagnesaemia 52.01 9.77 12 197779 25003 56069273
Bunion operation 51.83 9.77 39 197752 1166 56093110
Disability 51.80 9.77 147 197644 15633 56078643
Orthostatic hypotension 51.64 9.77 26 197765 33173 56061103
Drug specific antibody 51.55 9.77 49 197742 2031 56092245
Intestinal diaphragm disease 51.53 9.77 18 197773 92 56094184
Multiple organ dysfunction syndrome 51.28 9.77 66 197725 52704 56041572
Sleep disorder due to general medical condition, insomnia type 51.24 9.77 46 197745 43292 56050984
Plasma cell myeloma 51.10 9.77 53 197738 46593 56047683
Osteoporotic fracture 49.92 9.77 60 197731 3261 56091015
Therapy non-responder 49.36 9.77 377 197414 60978 56033298
Gamma-glutamyltransferase increased 48.65 9.77 24 197767 30981 56063295
Arthrodesis 48.22 9.77 53 197738 2613 56091663
Prescribed overdose 48.11 9.77 180 197611 22116 56072160
Premature delivery 47.14 9.77 18 197773 27042 56067234
Emotional distress 46.75 9.77 218 197573 29545 56064731
Red blood cell sedimentation rate 46.33 9.77 66 197725 4242 56090034
Foetal exposure during pregnancy 46.20 9.77 31 197760 33792 56060484
Joint range of motion decreased 46.05 9.77 194 197597 25171 56069105
Respiratory failure 45.96 9.77 175 197616 94887 55999389
Pleuritic pain 45.76 9.77 86 197705 6971 56087305
Bone disorder 45.74 9.77 162 197629 19381 56074895
Renal failure 45.67 9.77 216 197575 110284 55983992
Limb discomfort 45.55 9.77 200 197591 26422 56067854
Wound infection 45.52 9.77 137 197654 15056 56079220
Condition aggravated 45.36 9.77 1557 196234 343341 55750935
Haematemesis 44.70 9.77 210 197581 28548 56065728
Lip swelling 44.67 9.77 197 197594 26075 56068201
Scleritis 44.63 9.77 60 197731 3651 56090625
Posterior reversible encephalopathy syndrome 44.30 9.77 3 197788 15957 56078319
Tendonitis 44.07 9.77 152 197639 17945 56076331
Bursitis 44.04 9.77 203 197588 27379 56066897
Gastric ulcer haemorrhage 43.86 9.77 67 197724 4586 56089690
Off label use 43.83 9.77 1557 196234 554623 55539653
Neutrophil count decreased 43.74 9.77 67 197724 49755 56044521
White blood cell count decreased 43.35 9.77 262 197529 125728 55968548
Nodule 43.28 9.77 154 197637 18465 56075811
Deafness 43.23 9.77 142 197649 16352 56077924
Dysstasia 43.22 9.77 158 197633 19196 56075080
Neovascularisation 43.02 9.77 33 197758 1016 56093260
Fear of injection 43.00 9.77 80 197711 6435 56087841
Synovial cyst 42.93 9.77 98 197693 9116 56085160
Feeding disorder 42.17 9.77 114 197677 11786 56082490
Paraesthesia 41.96 9.77 668 197123 129846 55964430
Pulmonary congestion 41.58 9.77 138 197653 15977 56078299
Wound 41.53 9.77 301 197490 138503 55955773
Drug resistance 40.49 9.77 11 197780 20531 56073745
Hypoglycaemia 40.08 9.77 85 197706 55730 56038546
Abnormal loss of weight 39.85 9.77 69 197722 5247 56089029
Choanal stenosis 39.19 9.77 11 197780 22 56094254
Joint effusion 38.81 9.77 128 197663 14770 56079506
Pericarditis 38.80 9.77 224 197567 108699 55985577
Duodenal ulcer haemorrhage 38.77 9.77 44 197747 2248 56092028
Hyperkalaemia 37.76 9.77 76 197715 50789 56043487
Weight decreased 37.44 9.77 1109 196682 239605 55854671
Cartilage atrophy 37.11 9.77 16 197775 155 56094121
Pulmonary hypertension 36.98 9.77 43 197748 35901 56058375
Blood parathyroid hormone decreased 36.82 9.77 87 197704 8277 56085999
Tachycardia 36.51 9.77 220 197571 105656 55988620
Hunger 36.43 9.77 62 197729 4649 56089627
Device expulsion 36.38 9.77 32 197759 30417 56063859
Sopor 36.30 9.77 14 197777 20908 56073368
Swelling face 35.75 9.77 327 197464 55742 56038534
Drug eruption 35.65 9.77 182 197609 25581 56068695
Sacroiliitis 35.15 9.77 46 197745 2726 56091550
Hypervolaemia 35.14 9.77 25 197766 26433 56067843
Dactylitis 35.12 9.77 40 197751 2052 56092224
Blepharospasm 34.99 9.77 51 197740 3347 56090929
Creatinine renal clearance decreased 34.53 9.77 5 197786 14554 56079722
Fracture delayed union 34.53 9.77 42 197749 2311 56091965
Myelodysplastic syndrome 33.85 9.77 8 197783 16398 56077878
Neuropathy peripheral 33.82 9.77 217 197574 102676 55991600
Respiratory distress 33.54 9.77 37 197754 31630 56062646
Wrist deformity 33.52 9.77 37 197754 1833 56092443
Tongue disorder 33.44 9.77 94 197697 9942 56084334
Ascites 33.43 9.77 50 197741 37494 56056782
Neoplasm progression 33.27 9.77 38 197753 31978 56062298
Uveitis 33.20 9.77 100 197691 10995 56083281
Soft tissue injury 32.83 9.77 34 197757 1565 56092711
International normalised ratio increased 32.53 9.77 66 197725 43975 56050301
Peripheral swelling 32.42 9.77 1066 196725 233660 55860616
Folliculitis 32.22 9.77 93 197698 54886 56039390
Smear cervix abnormal 31.98 9.77 44 197747 2737 56091539
Alopecia 31.92 9.77 786 197005 292672 55801604
Hypoxia 31.71 9.77 91 197700 53806 56040470
Serum sickness-like reaction 31.46 9.77 20 197771 452 56093824
COVID-19 31.43 9.77 146 197645 74912 56019364
Muscle injury 31.36 9.77 88 197703 52412 56041864
Osteonecrosis of jaw 31.10 9.77 43 197748 33315 56060961
Limb deformity 31.10 9.77 52 197739 3843 56090433
Alanine aminotransferase abnormal 31.04 9.77 55 197736 4260 56090016
Granuloma skin 30.67 9.77 73 197718 6978 56087298
Right ventricular failure 30.06 9.77 10 197781 16369 56077907
Feeling jittery 30.05 9.77 102 197689 11944 56082332
Panniculitis 29.72 9.77 89 197702 9753 56084523
Therapeutic response decreased 29.35 9.77 299 197492 52459 56041817
Upper gastrointestinal haemorrhage 29.08 9.77 128 197663 16926 56077350
Encephalopathy 28.67 9.77 50 197741 35275 56059001
Biliary dyskinesia 28.65 9.77 40 197751 2523 56091753
Electrolyte imbalance 28.23 9.77 14 197777 18019 56076257
Tooth infection 28.22 9.77 120 197671 15632 56078644
Myelosuppression 28.17 9.77 13 197778 17442 56076834
Headache 27.79 9.77 2302 195489 556742 55537534
Sedation complication 27.71 9.77 4 197787 11668 56082608
Skin ulcer 27.64 9.77 231 197560 38377 56055899
Gallbladder injury 27.34 9.77 28 197763 1272 56093004
Oesophageal spasm 27.34 9.77 41 197750 2761 56091515
Premature baby 27.05 9.77 17 197774 19188 56075088
Amnesia 26.96 9.77 265 197526 46057 56048219
Hyperglycaemia 26.90 9.77 59 197732 38222 56056054
Acute respiratory failure 26.90 9.77 42 197749 30952 56063324
Constipation 26.80 9.77 524 197267 201419 55892857
Seizure 26.59 9.77 296 197495 124823 55969453
Cerebral haemorrhage 26.55 9.77 37 197754 28569 56065707
Colitis 26.54 9.77 68 197723 41743 56052533
Rash pruritic 26.42 9.77 292 197499 52302 56041974
Walking aid user 26.12 9.77 77 197714 8366 56085910
Syncope 25.85 9.77 249 197542 107950 55986326
Tooth disorder 25.82 9.77 166 197625 25387 56068889
Adjustment disorder with depressed mood 25.71 9.77 56 197735 5047 56089229
Gastrooesophageal reflux disease 25.58 9.77 423 197368 82834 56011442
Tenderness 25.57 9.77 139 197652 20016 56074260
Photophobia 25.53 9.77 118 197673 15932 56078344
Acute myeloid leukaemia 25.35 9.77 14 197777 16958 56077318
Hepatic function abnormal 25.34 9.77 52 197739 34506 56059770
Neurotoxicity 25.13 9.77 12 197779 15783 56078493
Red blood cell count decreased 25.11 9.77 217 197574 36400 56057876
Blood creatine phosphokinase increased 25.10 9.77 37 197754 27915 56066361
Iritis 24.94 9.77 39 197752 2724 56091552
Myofascial pain syndrome 24.91 9.77 34 197757 2099 56092177
Goitre 24.57 9.77 58 197733 5515 56088761
Psychotic disorder 24.43 9.77 28 197763 23530 56070746
Skin necrosis 24.38 9.77 97 197694 12264 56082012
Cerebrovascular accident 24.33 9.77 227 197564 99043 55995233
Contraindicated product administered 23.93 9.77 839 196952 185447 55908829
Bone marrow failure 23.91 9.77 39 197752 28247 56066029
Oesophageal pain 23.89 9.77 42 197749 3233 56091043
Oesophageal ulcer 23.86 9.77 48 197743 4091 56090185
Urticaria 23.69 9.77 671 197120 144005 55950271
Adverse reaction 23.67 9.77 80 197711 9347 56084929
Lactic acidosis 23.60 9.77 56 197735 35290 56058986
Hepatotoxicity 23.59 9.77 46 197745 31107 56063169
Cardiac arrest 23.54 9.77 192 197599 86122 56008154
Impaired healing 23.37 9.77 432 197359 86409 56007867
Aorta hypoplasia 23.31 9.77 11 197780 134 56094142
Mucosal inflammation 23.24 9.77 75 197716 42735 56051541
Musculoskeletal discomfort 23.09 9.77 116 197675 16202 56078074
Body temperature decreased 23.05 9.77 125 197666 17983 56076293
Cytokine release syndrome 23.05 9.77 5 197786 10870 56083406
Palmar-plantar erythrodysaesthesia syndrome 22.99 9.77 24 197767 21041 56073235
Ankle arthroplasty 22.97 9.77 27 197764 1433 56092843
Back pain 22.96 9.77 1036 196755 236134 55858142
Immunodeficiency 22.96 9.77 115 197676 16042 56078234
Full blood count decreased 22.89 9.77 29 197762 23320 56070956
Sensitivity to weather change 22.86 9.77 63 197728 6586 56087690
Therapeutic product effect decreased 22.72 9.77 767 197024 168685 55925591
Abdominal pain 22.61 9.77 1119 196672 257686 55836590
Facet joint syndrome 22.46 9.77 63 197728 6654 56087622
Clear cell renal cell carcinoma 22.45 9.77 25 197766 1251 56093025
Disability assessment scale score increased 22.40 9.77 37 197754 2707 56091569
Bone lesion 22.31 9.77 55 197736 5375 56088901
Metastases to liver 22.02 9.77 26 197765 21560 56072716
Clostridium difficile colitis 22.02 9.77 20 197771 18718 56075558
Hepatocellular injury 22.00 9.77 37 197754 26477 56067799
Joint injury 21.96 9.77 160 197631 25494 56068782
Flank pain 21.82 9.77 104 197687 14221 56080055
Device related infection 21.63 9.77 27 197764 21853 56072423
Hepatic enzyme increased 21.44 9.77 449 197342 170935 55923341
Atrial fibrillation 21.44 9.77 262 197529 108635 55985641
Spinal fusion surgery 21.43 9.77 48 197743 4408 56089868
Agranulocytosis 21.34 9.77 29 197762 22630 56071646
Axial spondyloarthritis 21.33 9.77 13 197778 272 56094004
Rheumatoid lung 21.28 9.77 39 197752 3101 56091175
Macular degeneration 21.26 9.77 21 197770 18887 56075389
Electrocardiogram QT prolonged 21.22 9.77 109 197682 54479 56039797
Hepatic cytolysis 21.20 9.77 6 197785 10900 56083376
Skin papilloma 21.20 9.77 48 197743 4441 56089835
Haematocrit decreased 21.10 9.77 210 197581 36619 56057657
Neuroleptic malignant syndrome 21.07 9.77 7 197784 11471 56082805
Wrong technique in product usage process 21.04 9.77 119 197672 58049 56036227
Limb operation 21.01 9.77 42 197749 3564 56090712
Hypophagia 20.79 9.77 173 197618 28703 56065573
Joint noise 20.61 9.77 43 197748 3761 56090515
Atelectasis 20.48 9.77 127 197664 19181 56075095
Allodynia 20.30 9.77 19 197772 772 56093504
Device ineffective 20.22 9.77 11 197780 184 56094092
Gastroenteritis viral 20.22 9.77 132 197659 20292 56073984
Heart rate 20.21 9.77 8 197783 61 56094215
Collagen-vascular disease 20.20 9.77 9 197782 95 56094181
Allergy to chemicals 20.12 9.77 33 197758 2400 56091876
Pregnancy 20 9.77 55 197736 32978 56061298
Hodgkin's disease 19.96 9.77 19 197772 789 56093487
Ventricular tachycardia 19.90 9.77 18 197773 16883 56077393
Adenoiditis 19.84 9.77 7 197784 37 56094239
Endocarditis fibroplastica 19.83 9.77 5 197786 5 56094271
Blood creatinine increased 19.81 9.77 183 197608 80008 56014268
Malaise 19.73 9.77 1524 196267 366336 55727940
Irritable bowel syndrome 19.72 9.77 150 197641 68308 56025968
Renal mass 19.72 9.77 30 197761 2046 56092230
Lip dry 19.67 9.77 77 197714 9663 56084613
Blood glucose increased 19.66 9.77 169 197622 74982 56019294
Cardiomyopathy 19.53 9.77 17 197774 16241 56078035
Nail psoriasis 19.50 9.77 15 197776 464 56093812
Urosepsis 19.45 9.77 18 197773 16698 56077578
Chronic obstructive pulmonary disease 19.42 9.77 120 197671 57295 56036981
Paradoxical drug reaction 19.34 9.77 42 197749 3778 56090498
Blood pressure measurement 19.32 9.77 12 197779 260 56094016
Blood pressure systolic increased 19.28 9.77 224 197567 40612 56053664
Spondyloarthropathy 19.18 9.77 19 197772 829 56093447
Radiation associated pain 19.17 9.77 8 197783 71 56094205
Caesarean section 19.11 9.77 17 197774 16074 56078202
Duodenal ulcer 19.11 9.77 62 197729 7093 56087183
Liver injury 19.07 9.77 228 197563 41620 56052656
Pharyngeal swelling 18.97 9.77 51 197740 5255 56089021
Anaphylactic reaction 18.96 9.77 302 197489 58693 56035583
Hallucination, visual 18.96 9.77 20 197771 17448 56076828
Premature labour 18.94 9.77 9 197782 11873 56082403
Intestinal obstruction 18.93 9.77 44 197747 27927 56066349
Drug reaction with eosinophilia and systemic symptoms 18.69 9.77 50 197741 30254 56064022
Blood sodium decreased 18.69 9.77 31 197760 22303 56071973
Ileus 18.59 9.77 13 197778 13869 56080407
Human anti-human antibody test 18.48 9.77 14 197777 423 56093853
Sputum discoloured 18.42 9.77 99 197692 14193 56080083
Left ventricular dysfunction 18.40 9.77 8 197783 11115 56083161
Hepatic adenoma 18.39 9.77 12 197779 284 56093992
Metastases to bone 18.33 9.77 25 197766 19483 56074793
Aspirin-exacerbated respiratory disease 18.29 9.77 19 197772 878 56093398
Schizophrenia 18.26 9.77 7 197784 10492 56083784
Eye pain 18.21 9.77 177 197614 30670 56063606
Crepitations 18.19 9.77 60 197731 6924 56087352
Anti-transglutaminase antibody 18.16 9.77 5 197786 9 56094267
Tumour lysis syndrome 18.16 9.77 3 197788 7920 56086356
Cerebral infarction 18.13 9.77 32 197759 22473 56071803
Medication overuse headache 18.10 9.77 17 197774 694 56093582
Blood calcium decreased 18.08 9.77 35 197756 23734 56070542
Depressed level of consciousness 18.04 9.77 120 197671 56313 56037963
Skin fissures 17.99 9.77 74 197717 9499 56084777
Hypokalaemia 17.92 9.77 229 197562 94208 56000068
Balance disorder 17.89 9.77 177 197614 76343 56017933
Product use in unapproved indication 17.89 9.77 368 197423 140454 55953822
Quality of life decreased 17.88 9.77 60 197731 6985 56087291
Transfusion 17.66 9.77 13 197778 13507 56080769
Rales 17.61 9.77 8 197783 10832 56083444
Gallbladder cholesterolosis 17.58 9.77 17 197774 720 56093556
Diabetes mellitus inadequate control 17.55 9.77 14 197777 13966 56080310
Peripheral venous disease 17.45 9.77 76 197715 10003 56084273
Haematoma 17.44 9.77 56 197735 31963 56062313
Cardiogenic shock 17.37 9.77 19 197772 16306 56077970
Nail dystrophy 17.35 9.77 19 197772 933 56093343
Infection 17.34 9.77 865 196926 199341 55894935
Cardiotoxicity 17.30 9.77 3 197788 7647 56086629
Periorbital oedema 17.30 9.77 49 197742 5205 56089071
Parkinsonism 17.22 9.77 6 197785 9540 56084736
Antinuclear antibody positive 17.13 9.77 58 197733 6783 56087493
Adrenergic syndrome 17.12 9.77 6 197785 31 56094245
Kidney infection 17.02 9.77 128 197663 20597 56073679
Loss of personal independence in daily activities 17.02 9.77 390 197401 80979 56013297
Libido increased 16.99 9.77 22 197769 1290 56092986
Product quality issue 16.95 9.77 56 197735 31680 56062596
Bone density increased 16.94 9.77 15 197776 567 56093709
Chronic spontaneous urticaria 16.93 9.77 20 197771 1067 56093209
Lipidosis 16.91 9.77 5 197786 13 56094263
No adverse event 16.91 9.77 68 197723 36306 56057970
HLA marker study positive 16.85 9.77 10 197781 199 56094077
Blood alkaline phosphatase increased 16.75 9.77 75 197716 38870 56055406
Aspergillus infection 16.73 9.77 3 197788 7462 56086814
Oedema peripheral 16.66 9.77 466 197325 170788 55923488
Pericardial effusion 16.64 9.77 45 197746 27130 56067146
Oedema 16.63 9.77 391 197400 81529 56012747
Endometriosis 16.61 9.77 45 197746 4657 56089619
Short stature 16.57 9.77 13 197778 414 56093862
Blood potassium increased 16.34 9.77 22 197769 17239 56077037
Intentional overdose 16.34 9.77 333 197458 67784 56026492
Cholelithiasis 16.26 9.77 211 197580 39253 56055023
Tendon rupture 16.23 9.77 61 197730 7509 56086767
Feeling abnormal 16.23 9.77 598 197193 133004 55961272
Lip oedema 16.21 9.77 37 197754 3441 56090835
Joint ankylosis 16.16 9.77 18 197773 901 56093375
Dry mouth 16.11 9.77 316 197475 63889 56030387
Tendon disorder 16.00 9.77 49 197742 5436 56088840
Angioedema 15.99 9.77 219 197572 41234 56053042
Anomaly of external ear congenital 15.86 9.77 9 197782 164 56094112
Bronchospasm 15.85 9.77 19 197772 15650 56078626
Hand deformity 15.76 9.77 356 197435 134136 55960140
Bacteraemia 15.76 9.77 19 197772 15612 56078664
Blood pressure fluctuation 15.47 9.77 213 197578 40147 56054129
IIIrd nerve injury 15.39 9.77 4 197787 5 56094271
Nerve compression 15.34 9.77 63 197728 8081 56086195
Amblyopia 15.27 9.77 10 197781 238 56094038
Bronchopulmonary aspergillosis 15.24 9.77 5 197786 8259 56086017
Acute respiratory distress syndrome 15.23 9.77 34 197757 21892 56072384
Cyanosis 15.12 9.77 20 197771 15790 56078486
Dysmenorrhoea 15.06 9.77 36 197755 3450 56090826
Fine motor skill dysfunction 15.05 9.77 42 197749 4423 56089853
Vaginal infection 14.86 9.77 55 197736 6722 56087554
Cholestasis 14.71 9.77 47 197744 26866 56067410
Circulatory collapse 14.67 9.77 32 197759 20771 56073505
Costovertebral angle tenderness 14.64 9.77 7 197784 88 56094188
Full blood count abnormal 14.61 9.77 46 197745 26416 56067860
Vaginal stricture 14.60 9.77 4 197787 7 56094269
Haemorrhage intracranial 14.53 9.77 14 197777 12741 56081535
Metastases to lung 14.38 9.77 12 197779 11706 56082570
Dysphagia 14.35 9.77 202 197589 81745 56012531
Depression 14.33 9.77 772 197019 179345 55914931
Eosinophil count increased 14.32 9.77 8 197783 9629 56084647
Laboratory test abnormal 14.30 9.77 42 197749 24653 56069623
Poor quality sleep 14.22 9.77 109 197682 17646 56076630
Cardio-respiratory arrest 14.20 9.77 125 197666 55196 56039080
Pre-eclampsia 14.20 9.77 6 197785 8480 56085796
Hepatic encephalopathy 14.17 9.77 9 197782 10101 56084175
Hypercholesterolaemia 14.16 9.77 18 197773 14455 56079821
Cholesterosis 14.16 9.77 12 197779 427 56093849
Hypoalbuminaemia 14.10 9.77 10 197781 10589 56083687
Polyneuropathy 14.10 9.77 15 197776 13035 56081241
Spinal cord infection 14.09 9.77 14 197777 613 56093663
Meningitis streptococcal 14.09 9.77 8 197783 146 56094130
Oliguria 14.07 9.77 6 197785 8434 56085842
Eosinophilia 14.06 9.77 31 197760 20046 56074230
Basal cell carcinoma 14.05 9.77 143 197648 25078 56069198
Blood pressure diastolic abnormal 14.05 9.77 79 197712 11519 56082757
Subdural haematoma 14.05 9.77 16 197775 13483 56080793
Limb asymmetry 14.04 9.77 16 197775 821 56093455
Hostility 14.03 9.77 24 197767 1807 56092469
Cognitive disorder 13.99 9.77 108 197683 49025 56045251
Post-traumatic neck syndrome 13.95 9.77 25 197766 1953 56092323
Pancreatitis 13.84 9.77 97 197694 44983 56049293
Hot flush 13.83 9.77 236 197555 46490 56047786
Deep vein thrombosis 13.72 9.77 361 197430 76616 56017660
Injection site reaction 13.67 9.77 263 197528 52984 56041292
Bone marrow oedema syndrome 13.64 9.77 4 197787 10 56094266
Enterocolitis 13.64 9.77 4 197787 7100 56087176
Status epilepticus 13.64 9.77 20 197771 15121 56079155
Blood pressure systolic abnormal 13.48 9.77 69 197722 9708 56084568
Genitourinary symptom 13.41 9.77 6 197785 64 56094212
Lymphopenia 13.38 9.77 24 197767 16750 56077526
Tooth hypoplasia 13.33 9.77 6 197785 65 56094211
Diabetic ketoacidosis 13.33 9.77 29 197762 18842 56075434
Blood albumin decreased 13.28 9.77 17 197774 13611 56080665
Sinus bradycardia 13.19 9.77 17 197774 13569 56080707
Pemphigoid 13.14 9.77 3 197788 6297 56087979
Malnutrition 13.12 9.77 18 197773 13990 56080286
Dyspepsia 13.06 9.77 385 197406 83086 56011190
Product dose omission issue 13.06 9.77 587 197204 204166 55890110
Cushingoid 13.03 9.77 56 197735 7328 56086948
Blood potassium decreased 12.99 9.77 81 197710 38591 56055685
Pre-existing condition improved 12.98 9.77 56 197735 7342 56086934
Sternal fracture 12.97 9.77 25 197766 2065 56092211
Normal newborn 12.96 9.77 5 197786 7465 56086811
Pneumocystis jirovecii pneumonia 12.95 9.77 22 197769 15679 56078597
Drug level increased 12.93 9.77 34 197757 20691 56073585
Sudden death 12.91 9.77 9 197782 9616 56084660
Spleen congestion 12.87 9.77 7 197784 117 56094159
Suicidal ideation 12.78 9.77 279 197512 57463 56036813
Therapeutic response shortened 12.77 9.77 66 197725 9320 56084956
Osteoarthritis 12.74 9.77 371 197420 79925 56014351
Urinary tract infection 12.73 9.77 703 197088 239810 55854466
Kounis syndrome 12.67 9.77 19 197772 1279 56092997
Accidental exposure to product by child 12.66 9.77 18 197773 1155 56093121
Breath sounds abnormal 12.65 9.77 8 197783 8999 56085277
Ischaemic stroke 12.64 9.77 25 197766 16817 56077459
Gastric disorder 12.62 9.77 175 197616 33035 56061241
Single umbilical artery 12.57 9.77 9 197782 249 56094027
Arrhythmia 12.56 9.77 72 197719 35011 56059265
Cardiac disorder 12.54 9.77 102 197689 45785 56048491
Metastases to fallopian tube 12.54 9.77 5 197786 39 56094237
Fixed eruption 12.51 9.77 16 197775 927 56093349
Ventricular fibrillation 12.50 9.77 12 197779 10940 56083336
Extra dose administered 12.49 9.77 45 197746 5428 56088848
Gastritis 12.44 9.77 181 197610 34521 56059755
Septic arthritis staphylococcal 12.44 9.77 11 197780 415 56093861
Hepatic cirrhosis 12.43 9.77 36 197755 21227 56073049
Pruritus 12.40 9.77 951 196840 315672 55778604
Prothrombin time ratio decreased 12.37 9.77 11 197780 418 56093858
Endodontic procedure 12.34 9.77 30 197761 2906 56091370
Pancreatitis acute 12.30 9.77 46 197745 25078 56069198
Oesophageal atresia 12.22 9.77 12 197779 518 56093758
Complication associated with device 12.21 9.77 22 197769 15328 56078948
Pleural effusion 12.19 9.77 219 197572 85261 56009015
Stomatitis 12.19 9.77 327 197464 120483 55973793
General physical health deterioration 12.18 9.77 481 197310 169529 55924747
Interstitial lung disease 12.09 9.77 274 197517 56789 56037487
Therapy cessation 12.03 9.77 52 197739 27212 56067064
Cytopenia 11.96 9.77 10 197781 9745 56084531
Polymenorrhagia 11.92 9.77 5 197786 45 56094231
Colostomy infection 11.90 9.77 3 197788 3 56094273
Wrong product procured 11.90 9.77 3 197788 3 56094273
Blood urea increased 11.85 9.77 45 197746 24428 56069848
Gait disturbance 11.82 9.77 694 197097 162627 55931649
Epistaxis 11.81 9.77 165 197626 66858 56027418
Plantar fasciitis 11.78 9.77 32 197759 3318 56090958
Parakeratosis 11.71 9.77 9 197782 278 56093998
Dandruff 11.70 9.77 8 197783 205 56094071
Finger deformity 11.70 9.77 50 197741 6527 56087749
Pulmonary oedema 11.66 9.77 119 197672 51024 56043252
Aggression 11.63 9.77 39 197752 21967 56072309
Rash 11.63 9.77 1936 195855 491111 55603165
Nasal ulcer 11.61 9.77 23 197768 1939 56092337
Lupus-like syndrome 11.60 9.77 16 197775 12411 56081865
Acquired cystic kidney disease 11.55 9.77 5 197786 49 56094227
Oral candidiasis 11.54 9.77 31 197760 18732 56075544
Therapeutic product effect variable 11.53 9.77 17 197774 1127 56093149
Aortic valve calcification 11.53 9.77 11 197780 458 56093818
Breast cancer stage II 11.51 9.77 3 197788 5755 56088521
Hepatic enzyme abnormal 11.44 9.77 42 197749 5113 56089163
Muscle spasms 11.37 9.77 591 197200 136780 55957496
Faecaloma 11.32 9.77 6 197785 7435 56086841
Ill-defined disorder 11.29 9.77 171 197620 68372 56025904
Trigger finger 11.24 9.77 35 197756 3918 56090358
Hypocoagulable state 11.22 9.77 16 197775 1029 56093247
Metabolic surgery 11.16 9.77 17 197774 1161 56093115
Gastrointestinal bacterial infection 11.11 9.77 14 197777 799 56093477
Colitis ulcerative 11.08 9.77 46 197745 24345 56069931
Claustrophobia 11.07 9.77 13 197778 689 56093587
Gastrointestinal submucosal tumour 11.06 9.77 4 197787 23 56094253
Obstructive airways disorder 11.05 9.77 28 197763 17254 56077022
Staphylococcal infection 11.04 9.77 82 197709 37536 56056740
Eating disorder 11.02 9.77 100 197691 17005 56077271
Dyspnoea exertional 10.98 9.77 131 197660 54558 56039718
Stress cardiomyopathy 10.91 9.77 8 197783 8328 56085948
Spondylitis 10.89 9.77 30 197761 3135 56091141
Unresponsive to stimuli 10.89 9.77 66 197725 31659 56062617
Anal abscess 10.88 9.77 36 197755 4161 56090115
Vaginal abscess 10.86 9.77 10 197781 398 56093878
Clostridium difficile infection 10.75 9.77 54 197737 27144 56067132
Congenital choroid plexus cyst 10.72 9.77 9 197782 316 56093960
Blood lactate dehydrogenase increased 10.69 9.77 37 197754 20638 56073638
Spinal pain 10.68 9.77 75 197716 11809 56082467
Costochondritis 10.68 9.77 25 197766 2364 56091912
Sinus headache 10.67 9.77 40 197751 4918 56089358
Tachypnoea 10.66 9.77 24 197767 15406 56078870
Infusion related reaction 10.63 9.77 613 197178 208318 55885958
Blood bilirubin increased 10.62 9.77 71 197720 33283 56060993
Supraventricular tachycardia 10.62 9.77 19 197772 13272 56081004
Analgesic drug level above therapeutic 10.50 9.77 7 197784 172 56094104
Acute kidney injury 10.41 9.77 717 197074 240046 55854230
Failure of child resistant product closure 10.40 9.77 4 197787 28 56094248
Hypertensive crisis 10.39 9.77 21 197770 14015 56080261
Helicobacter infection 10.36 9.77 188 197603 73080 56021196
Pseudodementia 10.24 9.77 5 197786 66 56094210
Myoclonus 10.22 9.77 24 197767 15179 56079097
Spinal osteoarthritis 10.21 9.77 88 197703 14748 56079528
Blood pressure decreased 10.18 9.77 146 197645 58904 56035372
Diffuse large B-cell lymphoma 10.17 9.77 6 197785 7010 56087266
Knee arthroplasty 10.16 9.77 215 197576 44044 56050232
Pneumonia bacterial 10.13 9.77 8 197783 8020 56086256
Antimitochondrial antibody positive 10.11 9.77 5 197786 68 56094208
Adverse drug reaction 10.08 9.77 300 197491 64832 56029444
Atrioventricular block complete 10.06 9.77 7 197784 7487 56086789
Therapy interrupted 10.05 9.77 51 197740 25574 56068702
Kyphoscoliosis 10.01 9.77 10 197781 441 56093835
Tracheo-oesophageal fistula 9.98 9.77 11 197780 544 56093732
Epstein-Barr virus infection 9.98 9.77 7 197784 7456 56086820
Mental status changes 9.95 9.77 84 197707 37417 56056859
Concussion 9.88 9.77 56 197735 8190 56086086
Conjunctivitis 9.87 9.77 102 197689 17958 56076318
Peripheral nerve operation 9.84 9.77 3 197788 9 56094267
Myopathy 9.81 9.77 12 197779 9800 56084476
Lip and/or oral cavity cancer 9.80 9.77 12 197779 665 56093611

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Ankylosing spondylitis 325.54 11.00 188 70650 5693 31620813
Gastric haemorrhage 259.97 11.00 198 70640 9607 31616899
Arthralgia 201.95 11.00 769 70069 150655 31475851
Joint swelling 198.70 11.00 396 70442 53035 31573471
Duodenal ulcer 188.75 11.00 164 70674 9600 31616906
Psoriatic arthropathy 176.57 11.00 220 70618 19663 31606843
Musculoskeletal stiffness 174.13 11.00 323 70515 41002 31585504
Pain 168.99 11.00 844 69994 185915 31440591
Upper gastrointestinal haemorrhage 126.19 11.00 203 70635 22980 31603526
Gastrointestinal haemorrhage 117.94 11.00 429 70409 82120 31544386
Acne cystic 110.64 11.00 42 70796 468 31626038
Neutropenia 105.55 11.00 95 70743 140269 31486237
Rheumatoid arthritis 104.65 11.00 288 70550 47521 31578985
Off label use 101.61 11.00 416 70422 346858 31279648
Death 98.11 11.00 444 70394 360125 31266381
Melaena 93.70 11.00 218 70620 32436 31594070
Gastric ulcer 93.47 11.00 138 70700 14496 31612010
Psoriasis 84.56 11.00 263 70575 46456 31580050
Febrile neutropenia 82.90 11.00 90 70748 121759 31504747
Duodenal ulcer haemorrhage 78.45 11.00 73 70765 4673 31621833
Pain in extremity 76.76 11.00 483 70355 115720 31510786
Milk-alkali syndrome 74.79 11.00 32 70806 496 31626010
Arthritis 73.33 11.00 178 70660 27207 31599299
Completed suicide 70.44 11.00 396 70442 91118 31535388
Faeces discoloured 67.33 11.00 115 70723 13671 31612835
Congenital hiatus hernia 65.26 11.00 30 70808 556 31625950
Neck pain 64.67 11.00 152 70686 22758 31603748
Haematemesis 63.69 11.00 162 70676 25491 31601015
Sacroiliitis 63.63 11.00 39 70799 1319 31625187
Gastric ulcer haemorrhage 61.09 11.00 66 70772 5057 31621449
Pancytopenia 61.03 11.00 63 70775 87253 31539253
Thrombocytopenia 58.33 11.00 147 70691 142600 31483906
Back pain 58.06 11.00 431 70407 108982 31517524
Sepsis 57.14 11.00 163 70675 151766 31474740
Cardiac failure 55.69 11.00 66 70772 85887 31540619
Peptic ulcer 53.30 11.00 45 70793 2531 31623975
Lip swelling 52.18 11.00 101 70737 13222 31613284
Angioedema 48.17 11.00 175 70663 33443 31593063
Leukopenia 47.29 11.00 36 70802 57792 31568714
Disability 45.29 11.00 54 70784 4607 31621899
Osteoarthritis 43.83 11.00 117 70721 18950 31607556
Joint injury 43.11 11.00 69 70769 7772 31618734
Pneumonia 42.74 11.00 512 70326 334800 31291706
Septic shock 42.63 11.00 51 70787 66107 31560399
Enthesopathy 42.21 11.00 50 70788 4237 31622269
Cytomegalovirus infection 40.74 11.00 4 70834 24703 31601803
Duodenal ulcer perforation 40.28 11.00 31 70807 1526 31624980
Synovitis 39.68 11.00 86 70752 12197 31614309
Drug hypersensitivity 39.63 11.00 288 70550 72311 31554195
General physical health deterioration 39.53 11.00 126 70712 113309 31513197
Gastritis 39.28 11.00 117 70721 20175 31606331
Muscle swelling 38.94 11.00 18 70820 338 31626168
Arthropathy 38.61 11.00 130 70708 23921 31602585
Atrial fibrillation 38.54 11.00 128 70710 113655 31512851
Drug resistance 38.14 11.00 4 70834 23449 31603057
Musculoskeletal discomfort 37.52 11.00 61 70777 6962 31619544
Abdominal discomfort 35.65 11.00 217 70621 51350 31575156
C-reactive protein abnormal 35.57 11.00 63 70775 7706 31618800
Withdrawal arrhythmia 35.05 11.00 10 70828 40 31626466
Gastritis erosive 34.32 11.00 52 70786 5587 31620919
Gastrointestinal ulcer 34.27 11.00 29 70809 1636 31624870
Musculoskeletal disorder 33.59 11.00 52 70786 5692 31620814
Bradycardia 33.53 11.00 65 70773 69262 31557244
Seronegative arthritis 33.36 11.00 23 70815 953 31625553
Diverticulitis 32.82 11.00 104 70734 18541 31607965
Lymphocyte count abnormal 32.79 11.00 21 70817 768 31625738
Product use in unapproved indication 32.59 11.00 113 70725 99058 31527448
Peripheral swelling 31.89 11.00 260 70578 67605 31558901
Urticaria 31.85 11.00 229 70609 57288 31569218
Gastrointestinal fistula 31.79 11.00 16 70822 365 31626141
Grip strength decreased 31.39 11.00 34 70804 2612 31623894
Back disorder 31.30 11.00 52 70786 6041 31620465
Accidental exposure to product by child 30.59 11.00 26 70812 1476 31625030
Renal papillary necrosis 30.45 11.00 12 70826 149 31626357
Pyrexia 30.41 11.00 487 70351 303353 31323153
Tendonitis 30.06 11.00 62 70776 8496 31618010
Hypoglycaemia 30.01 11.00 42 70796 50904 31575602
Dactylitis 29.13 11.00 20 70818 823 31625683
Migraine 28.63 11.00 83 70755 14097 31612409
Therapeutic product effect incomplete 28.39 11.00 181 70657 43515 31582991
Eye swelling 28.23 11.00 63 70775 9113 31617393
Exposure to communicable disease 27.46 11.00 11 70827 143 31626363
Drug ineffective 27.29 11.00 1111 69727 394462 31232044
Loss of personal independence in daily activities 26.97 11.00 130 70708 28158 31598348
Discomfort 26.77 11.00 89 70749 16267 31610239
Drug interaction 26.66 11.00 318 70520 208225 31418281
Glomerulonephritis membranous 26.59 11.00 21 70817 1074 31625432
Hyponatraemia 26.38 11.00 81 70757 73718 31552788
Fibromyalgia 26.25 11.00 32 70806 2794 31623712
Hypokalaemia 26.10 11.00 50 70788 53524 31572982
Ascites 26.01 11.00 32 70806 40981 31585525
Uveitis 25.87 11.00 51 70787 6765 31619741
Hospitalisation 25.59 11.00 45 70793 49762 31576744
Drug abuse 25.58 11.00 105 70733 87653 31538853
IgM nephropathy 25.53 11.00 8 70830 47 31626459
Pseudoporphyria 25.08 11.00 13 70825 316 31626190
Metabolic alkalosis 25.06 11.00 22 70816 1305 31625201
Musculoskeletal pain 24.87 11.00 132 70706 29696 31596810
Neutrophil count decreased 24.67 11.00 41 70797 46353 31580153
Nasopharyngitis 24.37 11.00 232 70606 63013 31563493
Mycobacterium tuberculosis complex test positive 23.73 11.00 20 70818 1122 31625384
Obstructive pancreatitis 23.67 11.00 14 70824 443 31626063
Joint stiffness 23.54 11.00 62 70776 9959 31616547
Gastroduodenal ulcer 23.51 11.00 13 70825 361 31626145
Platelet count decreased 23.19 11.00 148 70690 110287 31516219
Penile swelling 23.06 11.00 17 70821 784 31625722
White blood cell count decreased 22.79 11.00 109 70729 87289 31539217
Energy increased 22.64 11.00 20 70818 1196 31625310
Headache 22.45 11.00 553 70285 183099 31443407
Plasma cell myeloma 22.45 11.00 59 70779 56472 31570034
Acute biphenotypic leukaemia 22.39 11.00 8 70830 74 31626432
Spinal pain 22.35 11.00 41 70797 5154 31621352
Acute myeloid leukaemia 22.24 11.00 7 70831 18665 31607841
Ulcer 22.18 11.00 52 70786 7769 31618737
Joint effusion 21.97 11.00 38 70800 4561 31621945
Disease progression 21.78 11.00 116 70722 90348 31536158
Spinal osteoarthritis 21.77 11.00 48 70790 6887 31619619
Rectal haemorrhage 21.53 11.00 147 70691 36157 31590349
Fracture 21.47 11.00 45 70793 6235 31620271
Abdominal pain upper 21.39 11.00 228 70610 63774 31562732
Rash pruritic 21.39 11.00 108 70730 23830 31602676
Inflammation 21.25 11.00 112 70726 25129 31601377
Gastrooesophageal reflux disease 21.20 11.00 139 70699 33732 31592774
Blood pressure systolic increased 21.17 11.00 93 70745 19377 31607129
Neck injury 21.12 11.00 19 70819 1164 31625342
Exostosis 21.09 11.00 34 70804 3852 31622654
Myelosuppression 20.87 11.00 4 70834 14916 31611590
Neuroleptic malignant syndrome 20.68 11.00 6 70832 16863 31609643
Gamma-glutamyltransferase increased 20.67 11.00 19 70819 27806 31598700
Mucosal inflammation 20.65 11.00 28 70810 34399 31592107
Hepatic function abnormal 20.49 11.00 38 70800 41184 31585322
Respiratory tract malformation 20.42 11.00 4 70834 0 31626506
Steatorrhoea 20.40 11.00 15 70823 689 31625817
Swollen tongue 20.18 11.00 69 70769 12793 31613713
Tendon pain 20.10 11.00 28 70810 2787 31623719
Hepatitis B core antibody positive 19.98 11.00 11 70827 303 31626203
Tuberculin test positive 19.95 11.00 18 70820 1107 31625399
Failure of child resistant product closure 19.79 11.00 6 70832 31 31626475
COVID-19 19.71 11.00 60 70778 54761 31571745
Rheumatoid nodule 19.64 11.00 27 70811 2654 31623852
Hiatus hernia 19.50 11.00 46 70792 6901 31619605
Pulmonary fibrosis 19.21 11.00 81 70757 16579 31609927
Insomnia 19.13 11.00 308 70530 94528 31531978
Sensitivity to weather change 19.07 11.00 20 70818 1481 31625025
Diverticular perforation 18.97 11.00 29 70809 3140 31623366
Influenza like illness 18.82 11.00 109 70729 25328 31601178
Epilepsy 18.64 11.00 12 70826 21029 31605477
Lipoma 18.61 11.00 20 70818 1523 31624983
Blood cholesterol increased 18.60 11.00 81 70757 16812 31609694
Anxiety 18.50 11.00 296 70542 90737 31535769
Gangrene neonatal 18.43 11.00 9 70829 192 31626314
Inappropriate schedule of product administration 18.38 11.00 184 70654 50639 31575867
Nephrolithiasis 18.22 11.00 114 70724 27225 31599281
Eosinophilic pneumonia 18.06 11.00 28 70810 3069 31623437
Electrocardiogram QT prolonged 18.03 11.00 36 70802 37951 31588555
Swelling 18.01 11.00 144 70694 37214 31589292
Hypoaesthesia 17.99 11.00 198 70640 55824 31570682
Mobility decreased 17.97 11.00 114 70724 27355 31599151
Syndesmophyte 17.90 11.00 7 70831 85 31626421
Gastric ulcer perforation 17.87 11.00 16 70822 974 31625532
Respiratory failure 17.87 11.00 143 70695 101306 31525200
Drug tolerance 17.84 11.00 25 70813 2502 31624004
Gait disturbance 17.68 11.00 257 70581 77238 31549268
Blood bilirubin unconjugated 17.66 11.00 4 70834 4 31626502
Depression 17.60 11.00 293 70545 90522 31535984
Vanishing bile duct syndrome 17.47 11.00 13 70825 608 31625898
Extra dose administered 17.44 11.00 29 70809 3371 31623135
Nervous system neoplasm 17.37 11.00 8 70830 149 31626357
Tongue disorder 17.21 11.00 36 70802 4981 31621525
Transient ischaemic attack 17.10 11.00 102 70736 23954 31602552
Malignant melanoma in situ 16.91 11.00 18 70820 1356 31625150
Intervertebral disc degeneration 16.86 11.00 38 70800 5533 31620973
Therapeutic response shortened 16.76 11.00 39 70799 5798 31620708
Back injury 16.75 11.00 30 70808 3702 31622804
Lymphocyte count decreased 16.69 11.00 13 70825 20636 31605870
Weight decrease neonatal 16.67 11.00 10 70828 325 31626181
Oesophageal injury 16.63 11.00 5 70833 25 31626481
Bone marrow failure 16.58 11.00 23 70815 27985 31598521
Oral pustule 16.54 11.00 9 70829 242 31626264
Renal arteriosclerosis 16.54 11.00 8 70830 167 31626339
Dyspepsia 16.53 11.00 127 70711 32426 31594080
Ulcer haemorrhage 16.37 11.00 24 70814 2503 31624003
Chronic pigmented purpura 16.33 11.00 7 70831 109 31626397
Aspergillus infection 16.32 11.00 3 70835 11525 31614981
Venous angioma of brain 16.31 11.00 5 70833 27 31626479
Product used for unknown indication 16.20 11.00 14 70824 813 31625693
Clumsiness 16.13 11.00 19 70819 1600 31624906
Diverticulum 16.10 11.00 41 70797 6453 31620053
Tracheal atresia 16.05 11.00 4 70834 8 31626498
Respiratory arrest 15.98 11.00 107 70731 26150 31600356
Skin turgor decreased 15.85 11.00 11 70827 461 31626045
Iritis 15.76 11.00 17 70821 1300 31625206
Peptic ulcer perforation 15.64 11.00 8 70830 189 31626317
Confusional state 15.63 11.00 207 70631 133127 31493379
Seizure 15.62 11.00 145 70693 99623 31526883
Incorrect dosage administered 15.48 11.00 15 70823 1010 31625496
Undifferentiated connective tissue disease 15.46 11.00 5 70833 33 31626473
Status epilepticus 15.41 11.00 4 70834 12102 31614404
Hypervolaemia 15.38 11.00 11 70827 18240 31608266
Skin irritation 15.30 11.00 33 70805 4664 31621842
Moaning 15.20 11.00 13 70825 744 31625762
Congenital umbilical hernia 15.10 11.00 9 70829 289 31626217
Neck mass 15.00 11.00 18 70820 1546 31624960
Drug intolerance 14.96 11.00 180 70658 51853 31574653
Pneumonia aspiration 14.93 11.00 41 70797 38685 31587821
Swelling face 14.76 11.00 90 70748 21300 31605206
Neurotoxicity 14.73 11.00 9 70829 16217 31610289
Bronchopulmonary aspergillosis 14.72 11.00 6 70832 13628 31612878
Cardiogenic shock 14.72 11.00 17 70821 22391 31604115
Throat tightness 14.63 11.00 44 70794 7625 31618881
Impaired work ability 14.46 11.00 37 70801 5840 31620666
Fixed eruption 14.39 11.00 17 70821 1436 31625070
Bacteraemia 14.38 11.00 11 70827 17623 31608883
Intentional overdose 14.08 11.00 148 70690 41241 31585265
Nightmare 13.98 11.00 59 70779 12078 31614428
Renal failure 13.90 11.00 193 70645 123137 31503369
Acute respiratory failure 13.82 11.00 26 70812 28029 31598477
Kounis syndrome 13.81 11.00 20 70818 2064 31624442
Application site haematoma 13.74 11.00 5 70833 49 31626457
Polyneuropathy 13.63 11.00 6 70832 13016 31613490
Spondyloarthropathy 13.62 11.00 11 70827 581 31625925
Paraesthesia 13.60 11.00 188 70650 55883 31570623
Encephalopathy 13.58 11.00 33 70805 32441 31594065
Post-traumatic neck syndrome 13.52 11.00 6 70832 102 31626404
Hypercholesterolaemia 13.41 11.00 44 70794 7986 31618520
Priapism 13.41 11.00 31 70807 4589 31621917
Inflammatory pain 13.33 11.00 7 70831 175 31626331
Breath sounds abnormal 13.30 11.00 36 70802 5876 31620630
Burning sensation 13.21 11.00 73 70765 16674 31609832
Loss of proprioception 13.20 11.00 9 70829 366 31626140
Neuralgia 13.14 11.00 57 70781 11809 31614697
Haemangioma 13.14 11.00 18 70820 1764 31624742
Orthostatic hypotension 13.11 11.00 21 70817 24098 31602408
Hypocalcaemia 13.06 11.00 18 70820 21960 31604546
Injection site rash 13.04 11.00 27 70811 3709 31622797
Agranulocytosis 13.03 11.00 17 70821 21230 31605276
Schizophrenia 13.01 11.00 4 70834 10826 31615680
Oral pruritus 12.96 11.00 8 70830 274 31626232
Peripheral artery thrombosis 12.90 11.00 20 70818 2192 31624314
Renal impairment 12.87 11.00 127 70711 86222 31540284
Joint space narrowing 12.82 11.00 6 70832 116 31626390
Rhinalgia 12.70 11.00 9 70829 390 31626116
Lumbar radiculopathy 12.58 11.00 12 70826 792 31625714
Tooth disorder 12.54 11.00 50 70788 9979 31616527
Joint range of motion decreased 12.50 11.00 38 70800 6623 31619883
Alcohol use 12.39 11.00 24 70814 3143 31623363
Inappropriate antidiuretic hormone secretion 12.32 11.00 5 70833 11382 31615124
Myelodysplastic syndrome 12.22 11.00 15 70823 19236 31607270
Steatohepatitis 12.20 11.00 8 70830 305 31626201
Therapeutic product effect decreased 12.17 11.00 116 70722 31506 31595000
Lymphocyte count 12.15 11.00 5 70833 70 31626436
Joint lock 12.09 11.00 14 70824 1158 31625348
Ligament calcification 12.08 11.00 7 70831 213 31626293
Hepatotoxicity 12.04 11.00 15 70823 19111 31607395
Fibromuscular dysplasia 12.04 11.00 3 70835 6 31626500
Juvenile idiopathic arthritis 12.02 11.00 17 70821 1716 31624790
Tenosynovitis 11.95 11.00 28 70810 4182 31622324
Local reaction 11.90 11.00 5 70833 74 31626432
Anaemia 11.89 11.00 375 70463 213147 31413359
Dystonia 11.88 11.00 4 70834 10221 31616285
Acute respiratory distress syndrome 11.86 11.00 23 70815 24517 31601989
Nail injury 11.82 11.00 4 70834 31 31626475
Progressive multifocal leukoencephalopathy 11.81 11.00 3 70835 9210 31617296
Vitamin B12 increased 11.77 11.00 7 70831 224 31626282
Blood glucose increased 11.74 11.00 84 70754 60999 31565507
Contraindicated product administered 11.68 11.00 80 70758 19692 31606814
Secondary amyloidosis 11.66 11.00 5 70833 78 31626428
Ventricular tachycardia 11.64 11.00 22 70816 23679 31602827
Oedema mouth 11.60 11.00 14 70824 1209 31625297
Lymphopenia 11.60 11.00 9 70829 14320 31612186
Nail bed bleeding 11.60 11.00 7 70831 230 31626276
Tandem gait test abnormal 11.60 11.00 4 70834 33 31626473
Proctitis ulcerative 11.49 11.00 5 70833 81 31626425
Alcoholic hangover 11.44 11.00 3 70835 8 31626498
Sleep apnoea syndrome 11.39 11.00 76 70762 18549 31607957
Dysstasia 11.26 11.00 52 70786 11066 31615440
Oxygen saturation decreased 11.25 11.00 64 70774 49051 31577455
Peptic ulcer haemorrhage 11.23 11.00 9 70829 470 31626036
Ear congestion 11.23 11.00 9 70829 470 31626036
Foetal exposure during pregnancy 11.23 11.00 50 70788 40826 31585680

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
C-reactive protein abnormal 403.17 9.98 551 223223 38028 70666642
Pain 381.08 9.98 3327 220447 625489 70079181
Ankylosing spondylitis 368.96 9.98 301 223473 11345 70693325
Musculoskeletal stiffness 352.91 9.98 1147 222627 146613 70558057
Arthralgia 352.69 9.98 2753 221021 500637 70204033
Psoriatic arthropathy 349.65 9.98 686 223088 64085 70640585
Death 324.21 9.98 705 223069 509356 70195314
Red blood cell sedimentation rate abnormal 314.42 9.98 345 223429 18958 70685712
Synovitis 296.75 9.98 990 222784 128238 70576432
Rheumatoid arthritis 295.58 9.98 1749 222025 290056 70414614
Joint swelling 295.04 9.98 1576 222198 251635 70453035
Drug hypersensitivity 266.94 9.98 1575 222199 260884 70443786
Arthropathy 262.16 9.98 1052 222722 149005 70555665
Neutropenia 251.59 9.98 264 223510 256892 70447778
Drug ineffective 234.19 9.98 4209 219565 935543 69769127
Febrile neutropenia 222.96 9.98 190 223584 204128 70500542
Arthritis 219.89 9.98 745 223029 97235 70607435
Pain in extremity 215.90 9.98 1770 222004 326312 70378358
Fibromyalgia 213.67 9.98 469 223305 47405 70657265
Pancytopenia 202.80 9.98 112 223662 150995 70553675
Gastric haemorrhage 191.32 9.98 230 223544 13955 70690715
Sepsis 188.65 9.98 300 223474 244245 70460425
Rheumatoid nodule 177.08 9.98 228 223546 14839 70689831
Cardiac failure 176.41 9.98 118 223656 143423 70561247
Gastric ulcer 173.07 9.98 338 223436 31452 70673218
Thrombocytopenia 166.47 9.98 313 223461 238797 70465873
Pyrexia 163.36 9.98 1183 222591 605769 70098901
Drug intolerance 162.22 9.98 1243 222531 224444 70480226
Leukopenia 161.28 9.98 67 223707 106493 70598177
Pneumonia 151.91 9.98 1180 222594 595052 70109618
Duodenal ulcer 151.74 9.98 213 223561 15067 70689603
Psoriasis 146.89 9.98 658 223116 97775 70606895
Anaemia 135.40 9.98 734 223040 402689 70301981
Musculoskeletal disorder 134.79 9.98 233 223541 19738 70684932
Juvenile idiopathic arthritis 133.51 9.98 125 223649 5675 70698995
Hyponatraemia 133.49 9.98 186 223588 159901 70544769
Drug interaction 130.77 9.98 689 223085 380752 70323918
Migraine 128.88 9.98 510 223264 71728 70632942
Human antichimeric antibody positive 126.47 9.98 71 223703 1419 70703251
Abdominal pain upper 123.64 9.98 1038 222736 192564 70512106
Body height below normal 123.22 9.98 76 223698 1819 70702851
Polyarthritis 120.54 9.98 159 223615 10597 70694073
Contraindicated product administered 118.55 9.98 779 222995 133833 70570837
Drug abuse 116.00 9.98 178 223596 147078 70557592
Pharyngitis 115.20 9.98 220 223554 20131 70684539
Injury 115.08 9.98 459 223315 64786 70639884
Bradycardia 115.07 9.98 134 223640 124481 70580189
Seronegative arthritis 114.81 9.98 91 223683 3288 70701382
Joint laxity 113.32 9.98 78 223696 2261 70702409
C-reactive protein increased 112.61 9.98 664 223110 109853 70594817
Impaired work ability 112.06 9.98 192 223582 16148 70688522
Inflammation 110.76 9.98 517 223257 78148 70626522
Neck pain 107.36 9.98 456 223318 66201 70638469
Joint destruction 106.11 9.98 100 223674 4578 70700092
Drug tolerance 104.39 9.98 123 223651 7305 70697365
Femur fracture 104.36 9.98 300 223474 35832 70668838
Gastrointestinal pain 104.17 9.98 130 223644 8197 70696473
Disease progression 103.85 9.98 211 223563 156461 70548209
Musculoskeletal pain 103.44 9.98 560 223214 89767 70614903
Upper gastrointestinal haemorrhage 102.34 9.98 305 223469 37172 70667498
Cytomegalovirus infection 101.23 9.98 6 223768 39752 70664918
Hypoaesthesia 100.64 9.98 829 222945 152910 70551760
Drug tolerance decreased 100.52 9.98 139 223635 9694 70694976
Mobility decreased 98.67 9.98 609 223165 102390 70602280
Off label use 98.60 9.98 1701 222073 741359 69963311
Dislocation of vertebra 98.46 9.98 98 223676 4802 70699868
Loose body in joint 97.90 9.98 57 223717 1224 70703446
Duodenal ulcer haemorrhage 97.33 9.98 113 223661 6605 70698065
Lip swelling 96.67 9.98 281 223493 33773 70670897
Grip strength decreased 95.57 9.98 175 223599 15510 70689160
Haematemesis 94.80 9.98 354 223420 48443 70656227
Platelet count decreased 94.40 9.98 270 223504 177952 70526718
Drug resistance 93.60 9.98 7 223767 38183 70666487
Confusional state 92.28 9.98 523 223251 283875 70420795
Enthesopathy 91.26 9.98 140 223634 10729 70693941
Gastric ulcer haemorrhage 90.98 9.98 123 223651 8395 70696275
Therapeutic product effect decreased 90.31 9.98 765 223009 142253 70562417
Disability 89.82 9.98 166 223608 14817 70689853
Foot deformity 86.14 9.98 197 223577 20458 70684212
Tendonitis 85.72 9.98 205 223569 21917 70682753
Peripheral swelling 85.39 9.98 1130 222644 235433 70469237
Atrial fibrillation 83.84 9.98 299 223475 184049 70520621
Ulcer 83.44 9.98 223 223551 25531 70679139
Red blood cell sedimentation rate increased 83.28 9.98 290 223484 38352 70666318
Deafness transitory 82.72 9.98 46 223728 902 70703768
Hypoglycaemia 81.30 9.98 107 223667 94257 70610413
Foot operation 81.16 9.98 88 223686 4769 70699901
Pseudoporphyria 79.41 9.98 38 223736 537 70704133
Dehydration 78.78 9.98 406 223368 225736 70478934
Osteoporosis 78.30 9.98 334 223440 48573 70656097
Shoulder arthroplasty 78.20 9.98 69 223705 2898 70701772
Obesity 78.01 9.98 223 223551 26548 70678122
Cardiac failure congestive 77.92 9.98 197 223577 135260 70569410
Multiple fractures 77.35 9.98 101 223673 6664 70698006
Toothache 77.10 9.98 176 223598 18254 70686416
Respiratory failure 76.51 9.98 274 223500 168461 70536209
Malignant neoplasm progression 74.81 9.98 171 223603 121568 70583102
Orthostatic hypotension 74.39 9.98 35 223739 51708 70652962
Tenosynovitis 74.12 9.98 147 223627 13829 70690841
Renal failure 73.10 9.98 327 223447 188743 70515927
Hypotension 72.72 9.98 871 222903 403510 70301160
Systemic lupus erythematosus rash 71.24 9.98 51 223723 1576 70703094
Wheelchair user 71.06 9.98 85 223689 5129 70699541
Nerve injury 70.99 9.98 108 223666 8216 70696454
Cholecystitis chronic 70.75 9.98 115 223659 9261 70695409
Plasma cell myeloma 70.53 9.98 76 223698 73125 70631545
Renal impairment 69.83 9.98 227 223547 143710 70560960
Respiratory tract congestion 68.84 9.98 164 223610 17489 70687181
Urticaria 68.76 9.98 802 222972 162247 70542423
Neutrophil count decreased 67.72 9.98 99 223675 83457 70621213
Joint effusion 67.20 9.98 150 223624 15327 70689343
Multiple organ dysfunction syndrome 66.21 9.98 153 223621 108362 70596308
White blood cell count decreased 65.92 9.98 294 223480 169847 70534823
Red blood cell sedimentation rate 65.21 9.98 79 223695 4831 70699839
Tenosynovitis stenosans 65.00 9.98 56 223718 2277 70702393
Joint range of motion decreased 64.71 9.98 205 223569 25821 70678849
Bone disorder 64.48 9.98 159 223615 17331 70687339
Posterior reversible encephalopathy syndrome 64.26 9.98 3 223771 24399 70680271
Ascites 64.11 9.98 71 223703 67476 70637194
Nephrolithiasis 63.67 9.98 307 223467 47016 70657654
Bone density decreased 63.66 9.98 123 223651 11351 70693319
Hepatic function abnormal 62.88 9.98 73 223701 67923 70636747
Rash 62.77 9.98 2079 221695 508483 70196187
Swelling face 62.07 9.98 376 223398 62788 70641882
Dyspnoea 62.06 9.98 1904 221870 768156 69936514
Gamma-glutamyltransferase increased 61.79 9.98 42 223732 50643 70654027
Gastrointestinal haemorrhage 61.58 9.98 684 223090 136724 70567946
Pulmonary arterial hypertension 59.68 9.98 15 223759 32840 70671830
Impaired healing 59.24 9.98 420 223354 73954 70630716
Cytokine release syndrome 59.16 9.98 7 223767 26460 70678210
Fear of injection 58.94 9.98 88 223686 6584 70698086
Faeces discoloured 57.60 9.98 201 223573 26608 70678062
Limb discomfort 57.28 9.98 215 223559 29490 70675180
Dactylitis 57.01 9.98 51 223723 2182 70702488
Synovial fluid analysis 56.46 9.98 47 223727 1822 70702848
Joint injury 56.21 9.98 200 223574 26732 70677938
Abdominal discomfort 55.93 9.98 970 222804 213688 70490982
Rash pruritic 55.69 9.98 365 223409 62626 70642044
COVID-19 55.40 9.98 161 223613 105596 70599074
Back pain 55.22 9.98 1180 222594 269972 70434698
Hypoxia 54.25 9.98 135 223639 93209 70611461
Blood parathyroid hormone decreased 54.11 9.98 100 223674 8924 70695746
Mycotic allergy 53.92 9.98 37 223737 1067 70703603
Congenital hiatus hernia 53.63 9.98 29 223745 537 70704133
Emotional distress 53.50 9.98 246 223528 36942 70667728
Drug specific antibody 53.05 9.98 50 223724 2289 70702381
Sacroiliitis 52.43 9.98 58 223716 3215 70701455
Gastrooesophageal reflux disease 52.18 9.98 476 223298 90363 70614307
Melaena 51.94 9.98 330 223444 56025 70648645
Product use in unapproved indication 51.50 9.98 413 223361 207065 70497605
Nodule 51.22 9.98 159 223615 19810 70684860
Bone marrow failure 50.50 9.98 48 223726 48962 70655708
Dizziness 50.28 9.98 1863 221911 462278 70242392
Pleuritic pain 50.13 9.98 96 223678 8801 70695869
Tongue disorder 49.56 9.98 121 223653 13106 70691564
Musculoskeletal discomfort 49.51 9.98 146 223628 17686 70686984
Hypomagnesaemia 49.39 9.98 34 223740 40730 70663940
Acute myeloid leukaemia 49.20 9.98 18 223756 30922 70673748
Encephalopathy 49.04 9.98 74 223700 61587 70643083
Neuroleptic malignant syndrome 48.96 9.98 11 223763 25996 70678674
Myelosuppression 48.85 9.98 17 223757 30128 70674542
Osteoporotic fracture 48.82 9.98 60 223714 3724 70700946
Hospitalisation 48.31 9.98 119 223655 82449 70622221
Hypervolaemia 48.27 9.98 33 223741 39673 70664997
Bunion operation 47.66 9.98 31 223743 816 70703854
Synovial cyst 47.63 9.98 93 223681 8649 70696021
Hyperglycaemia 47.32 9.98 82 223692 64590 70640080
Sopor 46.74 9.98 20 223754 31247 70673423
Completed suicide 46.08 9.98 988 222786 226147 70478523
Acute respiratory failure 46.06 9.98 61 223713 53604 70651066
Scleritis 46.03 9.98 57 223717 3565 70701105
Loss of personal independence in daily activities 45.79 9.98 439 223335 84471 70620199
Bursitis 45.70 9.98 186 223588 26487 70678183
Paraesthesia 45.52 9.98 678 223096 144859 70559811
Cartilage atrophy 45.37 9.98 18 223756 156 70704514
Pulmonary hypertension 45.18 9.98 48 223726 46488 70658182
Adrenal insufficiency 45.01 9.98 178 223596 25017 70679653
Granuloma skin 44.65 9.98 84 223690 7598 70697072
Ventricular tachycardia 44.64 9.98 30 223744 36393 70668277
Myelodysplastic syndrome 44.61 9.98 19 223755 29766 70674904
Aspergillus infection 44.58 9.98 3 223771 17865 70686805
Angioedema 44.52 9.98 361 223413 66249 70638421
Agranulocytosis 44.48 9.98 37 223737 40261 70664409
Mucosal inflammation 44.40 9.98 92 223682 67758 70636912
Neovascularisation 43.62 9.98 33 223741 1112 70703558
Fracture delayed union 42.89 9.98 42 223732 2017 70702653
Panniculitis 42.51 9.98 100 223674 10576 70694094
Dyspepsia 42.48 9.98 449 223325 88628 70616042
Osteonecrosis of jaw 42.43 9.98 40 223734 40962 70663708
Neurotoxicity 41.61 9.98 21 223753 29805 70674865
Tooth disorder 41.07 9.98 167 223607 23771 70680899
Smear cervix abnormal 41.07 9.98 44 223730 2352 70702318
Gait inability 40.88 9.98 272 223502 46903 70657767
Wound infection 40.74 9.98 135 223639 17407 70687263
Cerebral haemorrhage 40.60 9.98 67 223707 53797 70650873
Cardiogenic shock 40.49 9.98 33 223741 36274 70668396
Hepatotoxicity 39.83 9.98 48 223726 43938 70660732
Milk-alkali syndrome 39.79 9.98 32 223742 1181 70703489
Dysstasia 39.56 9.98 171 223603 25008 70679662
Arthrodesis 39.41 9.98 42 223732 2231 70702439
Lactic acidosis 39.40 9.98 92 223682 64932 70639738
Bronchopulmonary aspergillosis 39.30 9.98 9 223765 20993 70683677
Antibody test positive 39.08 9.98 44 223730 2487 70702183
Wrist deformity 38.82 9.98 38 223736 1824 70702846
Gastritis 38.57 9.98 257 223517 44334 70660336
Neoplasm progression 38.22 9.98 52 223722 45176 70659494
Nasopharyngitis 37.77 9.98 943 222831 221263 70483407
Prescribed overdose 37.77 9.98 178 223596 27003 70677667
Blood creatine phosphokinase increased 37.66 9.98 86 223688 61177 70643493
Functional gastrointestinal disorder 37.53 9.98 58 223716 4473 70700197
Hypokalaemia 37.41 9.98 251 223523 130937 70573733
Therapy non-responder 37.28 9.98 389 223385 76526 70628144
Seizure 37.24 9.98 370 223404 177592 70527078
Right ventricular failure 37.07 9.98 12 223762 22262 70682408
Blood pressure systolic increased 37.02 9.98 308 223466 56951 70647719
Limb deformity 36.95 9.98 50 223724 3415 70701255
Respiratory distress 36.70 9.98 73 223701 54577 70650093
Tachycardia 36.44 9.98 322 223452 158224 70546446
Hunger 36.40 9.98 59 223715 4739 70699931
Acute respiratory distress syndrome 36.33 9.98 46 223728 41208 70663462
Swelling 36.28 9.98 814 222960 187725 70516945
Schizophrenia 36.11 9.98 5 223769 16763 70687907
Tenderness 35.62 9.98 147 223627 21063 70683607
Accidental exposure to product by child 35.41 9.98 44 223730 2762 70701908
Clostridium difficile colitis 35.38 9.98 24 223750 28972 70675698
International normalised ratio increased 35.31 9.98 133 223641 80593 70624077
Blood glucose increased 35.20 9.98 186 223588 102796 70601874
Bacteraemia 34.78 9.98 25 223749 29284 70675386
Sensitivity to weather change 34.69 9.98 74 223700 7331 70697339
Oesophageal spasm 34.64 9.98 46 223728 3085 70701585
Gastrointestinal ulcer 34.48 9.98 46 223728 3099 70701571
Septic shock 34.45 9.98 210 223564 112048 70592622
General physical health deterioration 33.86 9.98 532 223242 235499 70469171
Malaise 33.65 9.98 1679 222095 431253 70273417
Syncope 33.64 9.98 347 223427 165362 70539308
Adjustment disorder with depressed mood 33.51 9.98 53 223721 4170 70700500
Intestinal diaphragm disease 33.35 9.98 18 223756 332 70704338
Blepharospasm 32.95 9.98 50 223724 3795 70700875
Electrocardiogram QT prolonged 32.52 9.98 144 223630 83373 70621297
Exposure during pregnancy 32.51 9.98 154 223620 87563 70617107
Tooth infection 32.44 9.98 120 223654 16343 70688327
Ventricular fibrillation 32.33 9.98 23 223751 27088 70677582
Liver injury 32.24 9.98 231 223543 40804 70663866
Headache 31.93 9.98 2182 221592 578223 70126447
Photophobia 31.91 9.98 130 223644 18520 70686150
Withdrawal arrhythmia 31.65 9.98 10 223764 40 70704630
Alanine aminotransferase abnormal 31.56 9.98 75 223699 7984 70696686
Diabetes mellitus inadequate control 31.51 9.98 16 223758 22629 70682041
Intestinal obstruction 31.45 9.98 46 223728 38779 70665891
Peptic ulcer 31.40 9.98 61 223713 5652 70699018
Pathogen resistance 30.99 9.98 3 223771 13276 70691394
Therapeutic response decreased 30.91 9.98 301 223473 58152 70646518
Osteoarthritis 30.91 9.98 364 223410 73783 70630887
Arrhythmia 30.48 9.98 84 223690 56059 70648611
Electrolyte imbalance 30.48 9.98 24 223750 26837 70677833
Cardiac arrest 30.31 9.98 340 223434 159494 70545176
Infection 30.23 9.98 875 222899 209910 70494760
Psychotic disorder 30.22 9.98 45 223729 37656 70667014
Soft tissue injury 30.18 9.98 32 223742 1690 70702980
Ankle arthroplasty 30.02 9.98 27 223747 1163 70703507
Polyneuropathy 29.99 9.98 15 223759 21400 70683270
Serum sickness-like reaction 29.91 9.98 20 223754 552 70704118
Hallucination, visual 29.91 9.98 29 223745 29308 70675362
Feeding disorder 29.86 9.98 107 223667 14349 70690321
Subdural haematoma 29.83 9.98 29 223745 29269 70675401
Circulatory collapse 29.76 9.98 41 223733 35433 70669237
Premature delivery 29.72 9.98 15 223759 21289 70683381
Facet joint syndrome 29.69 9.98 62 223712 6051 70698619
Rheumatoid lung 29.67 9.98 45 223729 3414 70701256
Gastritis erosive 29.32 9.98 84 223690 10011 70694659
Cerebral infarction 29.27 9.98 57 223717 42952 70661718
Tendon disorder 29.01 9.98 64 223710 6487 70698183
Status epilepticus 29.00 9.98 21 223753 24505 70680165
Constipation 28.92 9.98 592 223182 251846 70452824
Walking aid user 28.83 9.98 72 223702 7909 70696761
Feeling jittery 28.76 9.98 91 223683 11452 70693218
Gastroenteritis viral 28.72 9.98 139 223635 21316 70683354
Intentional overdose 28.62 9.98 453 223321 97982 70606688
Rhabdomyolysis 27.91 9.98 182 223592 95578 70609092
Oesophageal pain 27.83 9.98 46 223728 3756 70700914
Urosepsis 27.68 9.98 21 223753 23928 70680742
Blood pressure decreased 27.66 9.98 172 223602 91343 70613327
Pneumonia aspiration 27.65 9.98 102 223672 62187 70642483
Gait disturbance 27.53 9.98 772 223002 184334 70520336
Nail psoriasis 27.50 9.98 18 223756 479 70704191
Skin necrosis 27.43 9.98 113 223661 16178 70688492
Ear infection 27.40 9.98 168 223606 28168 70676502
Palmar-plantar erythrodysaesthesia syndrome 27.40 9.98 33 223741 30214 70674456
Device related infection 27.20 9.98 37 223737 32148 70672522
Spondyloarthropathy 27.19 9.98 23 223751 912 70703758
Ileus 27.07 9.98 22 223752 24215 70680455
Pseudomonas infection 27.06 9.98 13 223761 18981 70685689
Pneumocystis jirovecii pneumonia 27.05 9.98 33 223741 30049 70674621
Gallbladder injury 26.85 9.98 25 223749 1127 70703543
Extra dose administered 26.66 9.98 66 223708 7211 70697459
Sedation complication 26.63 9.98 5 223769 13405 70691265
Skin ulcer 26.49 9.98 250 223524 47895 70656775
Neuropathy peripheral 26.46 9.98 264 223510 126632 70578038
Skin papilloma 26.46 9.98 55 223719 5351 70699319
Eosinophilia 26.10 9.98 55 223719 40264 70664406
Hyperkalaemia 26.05 9.98 213 223561 106378 70598292
Gastric disorder 25.84 9.98 187 223587 33135 70671535
Enterococcal infection 25.83 9.98 7 223767 14575 70690095
Crepitations 25.79 9.98 73 223701 8641 70696029
Hepatocellular injury 25.74 9.98 68 223706 46023 70658647
Creatinine renal clearance decreased 25.71 9.98 11 223763 17189 70687481
Therapeutic response shortened 25.65 9.98 94 223680 12744 70691926
Iritis 25.32 9.98 41 223733 3291 70701379
Maternal exposure during pregnancy 25.31 9.98 237 223537 115108 70589562
Pleural effusion 25.04 9.98 283 223491 132581 70572089
Tendon pain 24.83 9.98 53 223721 5253 70699417
Allergy to chemicals 24.71 9.98 31 223743 1965 70702705
Sleep disorder due to general medical condition, insomnia type 24.62 9.98 47 223727 35685 70668985
Kidney infection 24.59 9.98 124 223650 19331 70685339
Lymphocyte count decreased 24.50 9.98 64 223710 43475 70661195
Tumour lysis syndrome 24.34 9.98 19 223755 21341 70683329
Blood cholesterol increased 24.26 9.98 311 223463 64293 70640377
Lip dry 24.25 9.98 77 223697 9708 70694962
Uveitis 24.23 9.98 102 223672 14743 70689927
Feeling abnormal 24.17 9.98 604 223170 141715 70562955
Pharyngeal swelling 24.14 9.98 59 223715 6394 70698276
Depressed level of consciousness 24.07 9.98 169 223605 87262 70617408
Body temperature decreased 24.05 9.98 164 223610 28508 70676162
Fatigue 24.05 9.98 2960 220814 821359 69883311
Device ineffective 24.01 9.98 11 223763 140 70704530
Failure of child resistant product closure 23.98 9.98 9 223765 66 70704604
Atrioventricular block complete 23.81 9.98 9 223765 15154 70689516
Spinal fusion surgery 23.60 9.98 44 223730 3953 70700717
Lymphopenia 23.58 9.98 31 223743 27328 70677342
Ischaemic stroke 23.54 9.98 38 223736 30782 70673888
Venoocclusive liver disease 23.44 9.98 3 223771 10675 70693995
Cardiac failure acute 23.38 9.98 13 223761 17474 70687196
Hepatic cytolysis 23.26 9.98 16 223758 19176 70685494
Disability assessment scale score increased 23.18 9.98 37 223737 2934 70701736
Left ventricular dysfunction 23.09 9.98 14 223760 17943 70686727
Axial spondyloarthritis 23.00 9.98 16 223758 472 70704198
Wrong technique in product usage process 22.96 9.98 125 223649 68573 70636097
Skin fissures 22.92 9.98 83 223691 11187 70693483
Full blood count decreased 22.85 9.98 25 223749 23893 70680777
IgM nephropathy 22.82 9.98 8 223766 47 70704623
Depression 22.78 9.98 804 222970 198170 70506500
Gastroduodenal ulcer 22.76 9.98 16 223758 480 70704190
Blood lactate dehydrogenase increased 22.67 9.98 48 223726 35079 70669591
Metastases to liver 22.63 9.98 29 223745 25849 70678821
Drug level increased 22.57 9.98 51 223723 36418 70668252
Blood creatinine increased 22.32 9.98 317 223457 142684 70561986
Epstein-Barr virus infection 22.16 9.98 7 223767 13191 70691479
Fixed eruption 22.16 9.98 33 223741 2463 70702207
Blood alkaline phosphatase increased 22.12 9.98 102 223672 58419 70646251
Diverticulitis 22.11 9.98 215 223559 41519 70663151
Collagen-vascular disease 22.10 9.98 9 223765 84 70704586
Kounis syndrome 21.98 9.98 39 223735 3372 70701298
Renal papillary necrosis 21.95 9.98 14 223760 356 70704314
Oedema peripheral 21.84 9.98 550 223224 227541 70477129
Joint noise 21.81 9.98 39 223735 3392 70701278
Condition aggravated 21.79 9.98 1598 222176 426037 70278633
Anaphylactic reaction 21.78 9.98 345 223429 74629 70630041
Haematoma 21.68 9.98 79 223695 48339 70656331
Cardio-respiratory arrest 21.60 9.98 208 223566 100469 70604201
Cytopenia 21.59 9.98 14 223760 17309 70687361
Dry mouth 21.53 9.98 327 223447 70130 70634540
Haemorrhage intracranial 21.43 9.98 28 223746 24749 70679921
Heart rate 21.40 9.98 8 223766 58 70704612
Anxiety 21.33 9.98 874 222900 219456 70485214
Hepatic encephalopathy 21.26 9.98 23 223751 22095 70682575
Adenoiditis 21.24 9.98 7 223767 33 70704637
Drug eruption 21.18 9.98 204 223570 39292 70665378
Parkinsonism 21.07 9.98 11 223763 15314 70689356
Radiation associated pain 21.05 9.98 9 223765 96 70704574
Periorbital oedema 20.96 9.98 63 223711 7712 70696958
Abnormal loss of weight 20.91 9.98 63 223711 7721 70696949
Pemphigoid 20.91 9.98 9 223765 14013 70690657
Abdominal pain 20.89 9.98 1298 222476 340829 70363841
Knee arthroplasty 20.85 9.98 182 223592 34119 70670551
Trigger finger 20.73 9.98 40 223734 3687 70700983
Prostate cancer 20.60 9.98 42 223732 31121 70673549
Blood bilirubin increased 20.57 9.98 108 223666 59793 70644877
Human anti-human antibody test 20.33 9.98 14 223760 406 70704264
Post-traumatic neck syndrome 20.33 9.98 28 223746 1945 70702725
Colitis 20.30 9.98 118 223656 63696 70640974
Hepatic failure 20.29 9.98 103 223671 57522 70647148
Biliary dyskinesia 20.28 9.98 31 223743 2368 70702302
Spinal osteoarthritis 20.23 9.98 99 223675 15249 70689421
Cardiotoxicity 20.21 9.98 5 223769 11065 70693605
Aplastic anaemia 20.17 9.98 14 223760 16702 70687968
Restlessness 20.03 9.98 67 223707 42061 70662609
Pancreatitis 19.87 9.98 116 223658 62552 70642118
Hepatocellular carcinoma 19.86 9.98 4 223770 10204 70694466
Muscle swelling 19.85 9.98 18 223756 784 70703886
Flank pain 19.68 9.98 108 223666 17394 70687276
Malnutrition 19.67 9.98 21 223753 20296 70684374
Endometriosis 19.58 9.98 36 223738 3200 70701470
Vaginal infection 19.47 9.98 48 223726 5230 70699440
Sternal fracture 19.34 9.98 30 223744 2321 70702349
Incorrect dosage administered 19.19 9.98 30 223744 2337 70702333
Labelled drug-drug interaction medication error 19.14 9.98 29 223745 24098 70680572
Nail dystrophy 19.12 9.98 19 223755 929 70703741
Muscle spasms 19.02 9.98 628 223146 153418 70551252
Cholestasis 18.96 9.98 82 223692 47790 70656880
COVID-19 pneumonia 18.82 9.98 25 223749 21944 70682726
Myoclonus 18.75 9.98 34 223740 26321 70678349
Nightmare 18.74 9.98 127 223647 22029 70682641
Swollen tongue 18.73 9.98 189 223585 36857 70667813
Medication overuse headache 18.72 9.98 17 223757 742 70703928
Lower respiratory tract infection 18.71 9.98 474 223300 111439 70593231
Anti-transglutaminase antibody 18.69 9.98 5 223769 9 70704661
Blood sodium decreased 18.66 9.98 44 223730 30954 70673716
Bone lesion 18.59 9.98 48 223726 5382 70699288
Limb asymmetry 18.57 9.98 15 223759 557 70704113
Immunodeficiency 18.20 9.98 106 223668 17449 70687221
Duodenitis 18.18 9.98 56 223718 6946 70697724
Pericardial effusion 18.15 9.98 69 223705 41707 70662963
Antinuclear antibody positive 18.07 9.98 55 223719 6778 70697892
Pulmonary oedema 18.07 9.98 169 223605 82109 70622561
Gastrointestinal fistula 18.01 9.98 16 223758 678 70703992
Decreased appetite 17.99 9.98 782 222992 303998 70400672
Finger deformity 17.76 9.98 51 223723 6085 70698585
Hypothyroidism 17.74 9.98 79 223695 45676 70658994
Failure to thrive 17.73 9.98 6 223768 10823 70693847
Quality of life decreased 17.65 9.98 63 223711 8432 70696238
Blood pressure diastolic abnormal 17.65 9.98 96 223678 15408 70689262
Blood pressure systolic abnormal 17.54 9.98 84 223690 12825 70691845
Drug level decreased 17.44 9.98 9 223765 12615 70692055
Rales 17.40 9.98 17 223757 17118 70687552
Progressive multifocal leukoencephalopathy 17.36 9.98 21 223753 19193 70685477
Dystonia 17.32 9.98 22 223752 19684 70684986
Myofascial pain syndrome 17.29 9.98 25 223749 1817 70702853
Aspartate aminotransferase increased 17.26 9.98 289 223485 126689 70577981
Toxic skin eruption 17.22 9.98 23 223751 20139 70684531
Amblyopia 17.20 9.98 10 223764 214 70704456
Bradyphrenia 17.20 9.98 5 223769 9941 70694729
Lipidosis 17.18 9.98 5 223769 14 70704656
Night sweats 17.13 9.98 212 223562 43472 70661198
Peripheral venous disease 17.11 9.98 73 223701 10614 70694056
Hepatic adenoma 17.10 9.98 11 223763 284 70704386
Hyperbilirubinaemia 17.07 9.98 28 223746 22540 70682130
Gastric ulcer perforation 17.06 9.98 26 223748 1981 70702689
Sudden death 17.02 9.98 25 223749 21039 70683631
Disseminated intravascular coagulation 16.97 9.98 52 223722 33546 70671124
Disorientation 16.92 9.98 110 223664 57813 70646857
Hepatic enzyme abnormal 16.90 9.98 51 223723 6256 70698414
Aspirin-exacerbated respiratory disease 16.87 9.98 20 223754 1195 70703475
Fall 16.87 9.98 1190 222584 442906 70261764
Bone density increased 16.84 9.98 15 223759 638 70704032
Haematocrit decreased 16.83 9.98 264 223510 56994 70647676
Hypophosphataemia 16.80 9.98 16 223758 16310 70688360
Eye pain 16.77 9.98 173 223601 33929 70670741
Hypercapnia 16.77 9.98 3 223771 8326 70696344
Endocarditis fibroplastica 16.69 9.98 5 223769 16 70704654
Dementia 16.69 9.98 28 223746 22337 70682333
Chronic spontaneous urticaria 16.62 9.98 19 223755 1092 70703578
Blood calcium decreased 16.54 9.98 42 223732 28804 70675866
Unresponsive to stimuli 16.53 9.98 96 223678 51835 70652835
Peptic ulcer perforation 16.51 9.98 12 223762 380 70704290
Bladder cancer 16.49 9.98 18 223756 17224 70687446
Inappropriate schedule of product administration 16.38 9.98 450 223324 107105 70597565
Mouth ulceration 16.30 9.98 173 223601 34176 70670494
Blood bilirubin unconjugated 16.29 9.98 4 223770 4 70704666
Allodynia 16.24 9.98 21 223753 1372 70703298
Shock 16.16 9.98 69 223705 40356 70664314
Hostility 16.13 9.98 27 223747 2228 70702442
Hip arthroplasty 16.12 9.98 147 223627 27893 70676777
Colitis ulcerative 16.09 9.98 54 223720 33869 70670801
Back disorder 16.03 9.98 71 223703 10493 70694177
Transaminases increased 16.02 9.98 85 223689 46933 70657737
Goitre 16.00 9.98 44 223730 5122 70699548
Blood potassium decreased 16.00 9.98 74 223700 42347 70662323
Blood pressure measurement 15.90 9.98 12 223762 403 70704267
Mucormycosis 15.89 9.98 3 223771 8011 70696659
Oxygen saturation decreased 15.82 9.98 265 223509 116164 70588506
Blood pressure fluctuation 15.82 9.98 268 223506 58744 70645926
IIIrd nerve injury 15.82 9.98 4 223770 5 70704665
Wheezing 15.79 9.98 399 223375 93771 70610899
Eye swelling 15.78 9.98 128 223646 23486 70681184
Penile swelling 15.73 9.98 14 223760 595 70704075
Aggression 15.72 9.98 89 223685 48357 70656313
Inappropriate antidiuretic hormone secretion 15.70 9.98 31 223743 23245 70681425
Joint stiffness 15.69 9.98 175 223599 35001 70669669
Clostridium difficile infection 15.67 9.98 66 223708 38750 70665920
Short stature 15.67 9.98 12 223762 412 70704258
Glomerulonephritis membranous 15.66 9.98 22 223752 1557 70703113
Oropharyngeal pain 15.54 9.98 406 223368 95904 70608766
Immune reconstitution inflammatory syndrome 15.52 9.98 11 223763 12979 70691691
Dysmenorrhoea 15.51 9.98 29 223745 2611 70702059
Myocarditis 15.48 9.98 22 223752 18771 70685899
Cystitis haemorrhagic 15.46 9.98 4 223770 8589 70696081
Renal mass 15.45 9.98 31 223743 2940 70701730
Eosinophilic pneumonia 15.41 9.98 42 223732 4863 70699807
Cachexia 15.34 9.98 6 223768 9894 70694776
Troponin increased 15.18 9.98 18 223756 16596 70688074
Neutropenic sepsis 15.14 9.98 35 223739 24795 70679875
Alanine aminotransferase increased 15.10 9.98 352 223422 147128 70557542
Vaginal stricture 15.02 9.98 4 223770 7 70704663
Acute biphenotypic leukaemia 14.99 9.98 8 223766 144 70704526
Chronic kidney disease 14.92 9.98 122 223652 60935 70643735
Cholangitis 14.85 9.98 9 223765 11540 70693130
Bronchospasm 14.83 9.98 31 223743 22761 70681909
Cognitive disorder 14.80 9.98 122 223652 60834 70643836
Nausea 14.76 9.98 2973 220801 849115 69855555
Hyperammonaemia 14.73 9.98 7 223767 10286 70694384
Respiratory acidosis 14.70 9.98 7 223767 10274 70694396
Device expulsion 14.69 9.98 30 223744 22216 70682454
Disease recurrence 14.53 9.98 65 223709 37538 70667132
Peripheral arterial occlusive disease 14.49 9.98 3 223771 7506 70697164
Hypertensive crisis 14.48 9.98 24 223750 19238 70685432
Eye irritation 14.48 9.98 101 223673 17687 70686983
Treatment failure 14.45 9.98 574 223200 143568 70561102
Type 2 diabetes mellitus 14.41 9.98 207 223567 43873 70660797
Second primary malignancy 14.38 9.98 12 223762 13039 70691631
Chronic obstructive pulmonary disease 14.38 9.98 166 223608 77475 70627195
Clear cell renal cell carcinoma 14.36 9.98 26 223748 2284 70702386
Hyperthyroidism 14.22 9.98 26 223748 20065 70684605
Metastases to bone 14.09 9.98 31 223743 22345 70682325
Renal cancer 14.08 9.98 10 223764 11786 70692884
Intervertebral disc protrusion 14.07 9.98 116 223658 21387 70683283
Subarachnoid haemorrhage 14.02 9.98 25 223749 19479 70685191
Inflammatory pain 14.00 9.98 16 223758 919 70703751
Back injury 14.00 9.98 60 223714 8742 70695928
Akathisia 13.92 9.98 11 223763 12282 70692388
Cardiomyopathy 13.91 9.98 40 223734 26333 70678337
Lip oedema 13.90 9.98 44 223730 5539 70699131
Meningitis streptococcal 13.90 9.98 8 223766 168 70704502
Pneumonia fungal 13.90 9.98 7 223767 9946 70694724
Hepatic cirrhosis 13.85 9.98 50 223724 30681 70673989
Pneumonitis 13.84 9.98 108 223666 54489 70650181
Tardive dyskinesia 13.84 9.98 7 223767 9922 70694748
Head injury 13.82 9.98 58 223716 34083 70670587
Atelectasis 13.80 9.98 146 223628 28816 70675854
Obstructive pancreatitis 13.77 9.98 14 223760 704 70703966
Staphylococcal bacteraemia 13.75 9.98 9 223765 11073 70693597
Hypernatraemia 13.74 9.98 12 223762 12749 70691921
Diffuse large B-cell lymphoma 13.73 9.98 13 223761 13289 70691381
Occult blood positive 13.70 9.98 48 223726 6365 70698305
Tandem gait test abnormal 13.65 9.98 5 223769 34 70704636
Caesarean section 13.64 9.98 10 223764 11597 70693073
Sputum discoloured 13.60 9.98 104 223670 18747 70685923
Limb operation 13.59 9.98 30 223744 3042 70701628
Adrenergic syndrome 13.58 9.98 7 223767 117 70704553
Atrioventricular block 13.58 9.98 12 223762 12676 70691994
Hyperuricaemia 13.48 9.98 9 223765 10957 70693713
Ventricular arrhythmia 13.42 9.98 4 223770 7826 70696844
Lipase increased 13.42 9.98 17 223757 15229 70689441
Uterine perforation 13.38 9.98 45 223729 5846 70698824
Colorectal cancer 13.34 9.98 5 223769 8465 70696205
Red blood cell count decreased 13.30 9.98 235 223539 51926 70652744
Hodgkin's disease 13.18 9.98 15 223759 858 70703812
Heparin-induced thrombocytopenia 13.16 9.98 6 223768 9031 70695639
Coma 13.15 9.98 207 223567 91637 70613033
Ocular hyperaemia 13.08 9.98 127 223647 24512 70680158
Undifferentiated connective tissue disease 13.06 9.98 5 223769 39 70704631
Metastases to fallopian tube 13.06 9.98 5 223769 39 70704631
Basal cell carcinoma 12.98 9.98 163 223611 33535 70671135
Brain herniation 12.98 9.98 3 223771 6953 70697717
Bacterial sepsis 12.94 9.98 4 223770 7643 70697027
Fine motor skill dysfunction 12.88 9.98 40 223734 4984 70699686
Joint ankylosis 12.88 9.98 20 223754 1549 70703121
Libido increased 12.86 9.98 22 223752 1847 70702823
Epistaxis 12.85 9.98 237 223537 102390 70602280
Pulmonary fibrosis 12.81 9.98 165 223609 34145 70670525
Dialysis 12.79 9.98 22 223752 17380 70687290
Allergic respiratory disease 12.78 9.98 6 223768 81 70704589
Vaginal abscess 12.77 9.98 10 223764 355 70704315
Concussion 12.77 9.98 57 223717 8452 70696218
Hallucination, auditory 12.72 9.98 24 223750 18304 70686366
Vision blurred 12.71 9.98 391 223383 94593 70610077
Bone marrow oedema syndrome 12.66 9.98 4 223770 16 70704654
Gallbladder cholesterolosis 12.65 9.98 12 223762 554 70704116
Tachypnoea 12.64 9.98 47 223727 28591 70676079
Endodontic procedure 12.64 9.98 26 223748 2511 70702159
Localised infection 12.61 9.98 160 223614 32998 70671672
Amnesia 12.61 9.98 233 223541 51922 70652748
Sinus headache 12.57 9.98 37 223737 4476 70700194
Intervertebral disc degeneration 12.56 9.98 81 223693 13819 70690851
Haemolytic anaemia 12.55 9.98 21 223753 16773 70687897
Polymenorrhagia 12.54 9.98 5 223769 44 70704626
Haematuria 12.53 9.98 134 223640 63439 70641231
Oesophageal ulcer 12.51 9.98 47 223727 6447 70698223
Adverse reaction 12.51 9.98 57 223717 8525 70696145
Diabetic ketoacidosis 12.46 9.98 54 223720 31458 70673212
Cushingoid 12.44 9.98 56 223718 8332 70696338
Appendicitis 12.44 9.98 21 223753 16712 70687958
Pulseless electrical activity 12.42 9.98 14 223760 13201 70691469
Left ventricular failure 12.40 9.98 6 223768 8722 70695948
Syndesmophyte 12.34 9.98 5 223769 46 70704624
Fluid retention 12.34 9.98 134 223640 63251 70641419
Sinus bradycardia 12.34 9.98 36 223738 23587 70681083
Device leakage 12.33 9.98 7 223767 9301 70695369
Renal arteriosclerosis 12.27 9.98 9 223765 289 70704381
Pneumonia bacterial 12.26 9.98 21 223753 16620 70688050
Musculoskeletal chest pain 12.18 9.98 118 223656 22763 70681907
Cerebrovascular accident 12.15 9.98 352 223422 143118 70561552
Product label confusion 12.14 9.98 14 223760 812 70703858
Helicobacter test positive 12.11 9.98 17 223757 1202 70703468
Pulmonary congestion 12.08 9.98 127 223647 25027 70679643
Nasal ulcer 12.03 9.98 21 223753 1792 70702878
Jaundice cholestatic 12.03 9.98 7 223767 9177 70695493
Expired product administered 12.02 9.98 46 223728 6367 70698303
Deformity 12.01 9.98 55 223719 8242 70696428
Anal incontinence 11.98 9.98 21 223753 16469 70688201
Congenital bowing of long bones 11.94 9.98 4 223770 20 70704650
Therapeutic product effect incomplete 11.93 9.98 477 223297 119405 70585265
Urinary retention 11.91 9.98 107 223667 52413 70652257
Granuloma 11.89 9.98 52 223722 7643 70697027
Glycosylated haemoglobin increased 11.87 9.98 23 223751 17368 70687302
Hiccups 11.72 9.98 7 223767 9045 70695625
Aphasia 11.70 9.98 84 223690 43165 70661505
Pre-eclampsia 11.70 9.98 3 223771 6482 70698188
Acute coronary syndrome 11.69 9.98 29 223745 20050 70684620
Sciatica 11.67 9.98 124 223650 24503 70680167
Acute kidney injury 11.67 9.98 1315 222459 473309 70231361
Sleep apnoea syndrome 11.66 9.98 156 223618 32557 70672113
Myopathy 11.54 9.98 26 223748 18586 70686084
Suicidal behaviour 11.49 9.98 28 223746 3028 70701642
Injection site reaction 11.46 9.98 221 223553 49631 70655039
Small intestinal haemorrhage 11.45 9.98 33 223741 3945 70700725
Tachyarrhythmia 11.42 9.98 3 223771 6379 70698291
Treatment noncompliance 11.41 9.98 93 223681 46481 70658189
Acquired cystic kidney disease 11.40 9.98 5 223769 57 70704613
Ejection fraction decreased 11.40 9.98 54 223720 30708 70673962
Device occlusion 11.36 9.98 10 223764 10585 70694085
Dysphagia 11.36 9.98 270 223504 112564 70592106
Infective pulmonary exacerbation of cystic fibrosis 11.29 9.98 13 223761 12145 70692525
Dandruff 11.24 9.98 9 223765 330 70704340
Generalised tonic-clonic seizure 11.23 9.98 81 223693 41580 70663090
Normal newborn 11.20 9.98 3 223771 6297 70698373
Altered state of consciousness 11.19 9.98 77 223697 39945 70664725
Endocarditis 11.16 9.98 9 223765 9945 70694725
Intestinal ischaemia 11.10 9.98 13 223761 12051 70692619
Tubulointerstitial nephritis 11.08 9.98 156 223618 32920 70671750
Enterocolitis 11.06 9.98 15 223759 13051 70691619
Brain natriuretic peptide increased 11.03 9.98 6 223768 8165 70696505
Deafness 11.00 9.98 101 223673 19202 70685468
Escherichia sepsis 11.00 9.98 5 223769 7538 70697132
Urinary incontinence 10.98 9.98 72 223702 37770 70666900
Eczema infected 10.96 9.98 5 223769 63 70704607
Stress cardiomyopathy 10.95 9.98 9 223765 9853 70694817
Lipoma 10.89 9.98 26 223748 2776 70701894
Poor quality sleep 10.86 9.98 105 223669 20244 70684426
Suicidal ideation 10.83 9.98 292 223482 69304 70635366
Asphyxia 10.80 9.98 10 223764 10332 70694338
Gynaecomastia 10.80 9.98 4 223770 6819 70697851
Staphylococcal infection 10.76 9.98 112 223662 53292 70651378
Drug reaction with eosinophilia and systemic symptoms 10.76 9.98 124 223650 57889 70646781
Haemoptysis 10.74 9.98 107 223667 51345 70653325
Chronic pigmented purpura 10.70 9.98 7 223767 186 70704484
Alcoholic hangover 10.70 9.98 3 223771 7 70704663
Vascular device infection 10.69 9.98 6 223768 8024 70696646
Hypercalcaemia 10.66 9.98 160 223614 34225 70670445
Tendon rupture 10.66 9.98 66 223708 11103 70693567
Mania 10.64 9.98 24 223750 17150 70687520
Carpal tunnel syndrome 10.62 9.98 91 223683 16966 70687704
Premature labour 10.62 9.98 6 223768 7994 70696676
Acute hepatic failure 10.59 9.98 48 223726 27624 70677046
Colon cancer 10.59 9.98 18 223756 14288 70690382
Venous angioma of brain 10.58 9.98 4 223770 30 70704640
Neutrophil count increased 10.55 9.98 46 223728 26749 70677921
Mental status changes 10.52 9.98 138 223636 62963 70641707
Eosinophil count increased 10.51 9.98 20 223754 15202 70689468
Liver disorder 10.50 9.98 134 223640 61434 70643236
Oral pustule 10.49 9.98 8 223766 273 70704397
Energy increased 10.40 9.98 26 223748 2858 70701812
Transfusion 10.36 9.98 28 223746 18808 70685862
Squamous cell carcinoma of skin 10.36 9.98 15 223759 12697 70691973
Nasal congestion 10.35 9.98 276 223498 65396 70639274
Pancreatitis acute 10.31 9.98 92 223682 45132 70659538
Candida infection 10.31 9.98 65 223709 34408 70670262
Application site haematoma 10.30 9.98 5 223769 73 70704597
Oesophageal injury 10.30 9.98 5 223769 73 70704597
Parakeratosis 10.28 9.98 9 223765 374 70704296
Oral discomfort 10.27 9.98 55 223719 8776 70695894
Fallopian tube cancer 10.25 9.98 4 223770 33 70704637
Nerve compression 10.25 9.98 52 223722 8126 70696544
Metastases to lung 10.24 9.98 23 223751 16461 70688209
End stage renal disease 10.24 9.98 12 223762 11121 70693549
Costochondritis 10.23 9.98 22 223752 2192 70702478
Penile ulceration 10.21 9.98 8 223766 284 70704386
Neutrophilia 10.20 9.98 5 223769 7216 70697454
Organising pneumonia 10.17 9.98 10 223764 10040 70694630
Diverticulum 10.13 9.98 76 223698 13617 70691053
Swollen joint count increased 10.12 9.98 76 223698 13624 70691046
Balance disorder 10.11 9.98 212 223562 89916 70614754
Dermatitis exfoliative 10.11 9.98 11 223763 10540 70694130
Pneumatosis intestinalis 10.10 9.98 3 223771 5884 70698786
Metabolic encephalopathy 10.10 9.98 7 223767 8356 70696314
Renal tubular atrophy 10.07 9.98 19 223755 1723 70702947
Full blood count abnormal 10.06 9.98 64 223710 33814 70670856
Haemolysis 10.04 9.98 13 223761 11538 70693132
Hypogammaglobulinaemia 10.02 9.98 13 223761 11525 70693145
Stupor 9.99 9.98 4 223770 6505 70698165

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G02CC02 GENITO URINARY SYSTEM AND SEX HORMONES
OTHER GYNECOLOGICALS
OTHER GYNECOLOGICALS
Antiinflammatory products for vaginal administration
ATC M01AE02 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M01AE56 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
ATC M02AA12 MUSCULO-SKELETAL SYSTEM
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
Antiinflammatory preparations, non-steroids for topical use
FDA CS M0001335 Anti-Inflammatory Agents, Non-Steroidal
FDA MoA N0000000160 Cyclooxygenase Inhibitors
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 D016861 Cyclooxygenase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006074 Gout Suppressants
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:35493 anti-pyretic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:35845 gout suppressants
CHEBI has role CHEBI:50629 COX-2 inhibitor
CHEBI has role CHEBI:50630 COX-1 inhibitor
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175722 Nonsteroidal Anti-inflammatory Drug

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

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




🐶 Veterinary Drug Use

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

🐶 Veterinary products

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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.36 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
500MG;EQ 85MG BASE TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG;EQ 10MG BASE TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA INC N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9393208 Sept. 3, 2029 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9220698 March 10, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8945621 Oct. 17, 2031 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS ALSO TAKING LOW DOSE ASPIRIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4018847 VUID
N0000147149 NUI
D00118 KEGG_DRUG
26159-34-2 SECONDARY_CAS_RN
4018846 VANDF
4018847 VANDF
C0027396 UMLSCUI
CHEBI:59527 CHEBI
NPS PDB_CHEM_ID
CHEMBL154 ChEMBL_ID
DB00788 DRUGBANK_ID
CHEMBL1200806 ChEMBL_ID
D009288 MESH_DESCRIPTOR_UI
156391 PUBCHEM_CID
5230 IUPHAR_LIGAND_ID
2979 INN_ID
57Y76R9ATQ UNII
142442 RXNORM
2108 MMSL
2111 MMSL
27852 MMSL
5155 MMSL
5156 MMSL
6350 MMSL
8137 MMSL
d00019 MMSL
002380 NDDF
002381 NDDF
11847009 SNOMEDCT_US
372588000 SNOMEDCT_US
42692007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0054-3630 SUSPENSION 125 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0054-3630 SUSPENSION 125 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1005 TABLET, DELAYED RELEASE 375 mg ORAL ANDA 28 sections
Naproxen HUMAN PRESCRIPTION DRUG LABEL 1 0093-1006 TABLET, DELAYED RELEASE 500 mg ORAL ANDA 28 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-0901 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1412 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 1 0113-1773 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Good Sense Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-4368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7033 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium pm HUMAN OTC DRUG LABEL 2 0113-7264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Basic Care Naproxen Sodium HUMAN OTC DRUG LABEL 1 0113-7368 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
basic care naproxen sodium HUMAN OTC DRUG LABEL 1 0113-7901 TABLET, FILM COATED 200 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
good sense naproxen sodium HUMAN OTC DRUG LABEL 2 0113-8264 TABLET, FILM COATED 220 mg ORAL ANDA 16 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-0899 SUSPENSION 125 mg ORAL NDA 29 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-1798 SUSPENSION 250 mg ORAL NDA 29 sections
Naprosyn HUMAN PRESCRIPTION DRUG LABEL 1 0121-2697 SUSPENSION 500 mg ORAL NDA 29 sections
Aleve Headache Pain HUMAN OTC DRUG LABEL 1 0280-0041 TABLET 220 mg ORAL NDA 17 sections
Aleve Headache Pain HUMAN OTC DRUG LABEL 1 0280-0041 TABLET 220 mg ORAL NDA 17 sections
Menstridol HUMAN OTC DRUG LABEL 1 0280-0270 TABLET 220 mg ORAL NDA 17 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 17 sections
Aleve PM HUMAN OTC DRUG LABEL 2 0280-1200 TABLET, FILM COATED 220 mg ORAL NDA 17 sections
AleveCaplets HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 17 sections
AleveCaplets HUMAN OTC DRUG LABEL 1 0280-6000 TABLET 220 mg ORAL NDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 17 sections
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 17 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 16 sections
AleveGelcaps HUMAN OTC DRUG LABEL 1 0280-6020 TABLET, COATED 220 mg ORAL NDA 16 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections
Aleve-D Sinus and Headache HUMAN OTC DRUG LABEL 2 0280-6045 TABLET 220 mg ORAL ANDA 17 sections