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
C-reactive protein abnormal 405.87 10.10 659 232788 45437 63210138
Death 400.05 10.10 473 232974 373908 62881667
Pharyngitis 371.05 10.10 413 233034 19730 63235845
Red blood cell sedimentation rate abnormal 366.81 10.10 407 233040 19375 63236200
Ankylosing spondylitis 312.12 10.10 279 233168 10195 63245380
Rheumatoid arthritis 270.49 10.10 1727 231720 252092 63003483
Drug hypersensitivity 260.09 10.10 1993 231454 308694 62946881
Musculoskeletal stiffness 258.60 10.10 1351 232096 183267 63072308
Psoriatic arthropathy 258.16 10.10 832 232615 90688 63164887
Deafness transitory 249.76 10.10 129 233318 1841 63253734
Fibromyalgia 234.93 10.10 740 232707 79680 63175895
Gastrointestinal pain 227.37 10.10 227 233220 9549 63246026
Synovitis 195.36 10.10 1266 232181 185652 63069923
Neutropenia 191.00 10.10 217 233230 174788 63080787
Arthralgia 190.33 10.10 3044 230403 566666 62688909
Anaemia 169.99 10.10 534 232913 292896 62962679
Febrile neutropenia 163.66 10.10 118 233329 118331 63137244
Rheumatoid nodule 154.68 10.10 248 233199 16907 63238668
Gait inability 151.58 10.10 484 232963 52475 63203100
C-reactive protein increased 150.79 10.10 719 232728 93988 63161587
Shoulder arthroplasty 150.79 10.10 122 233325 3880 63251695
Joint swelling 147.81 10.10 1847 231600 325819 62929756
Hyponatraemia 145.01 10.10 119 233328 111781 63143794
Disease progression 141.92 10.10 145 233302 122613 63132962
Obesity 140.19 10.10 328 233119 29624 63225951
Hypoaesthesia 139.35 10.10 1078 232369 167315 63088260
Body height below normal 138.00 10.10 91 233356 2092 63253483
Impaired work ability 136.65 10.10 237 233210 17238 63238337
Cardiac failure 136.50 10.10 79 233368 89063 63166512
Pancytopenia 135.95 10.10 95 233352 96838 63158737
Abdominal pain upper 135.09 10.10 1254 232193 205190 63050385
Pain in extremity 134.61 10.10 1833 231614 329653 62925922
Polyarthritis 132.83 10.10 175 233272 9971 63245604
Injury 129.87 10.10 574 232873 72673 63182902
Thrombocytopenia 129.39 10.10 223 233224 150934 63104641
Arthritis 128.97 10.10 798 232649 115123 63140452
Arthropathy 128.84 10.10 1375 232072 233417 63022158
Human antichimeric antibody positive 127.07 10.10 79 233368 1635 63253940
Migraine 126.86 10.10 730 232717 102616 63152959
Inflammation 124.06 10.10 615 232832 81658 63173917
Foot operation 122.52 10.10 142 233305 7089 63248486
Pyrexia 122.50 10.10 1123 232324 469355 62786220
Leukopenia 121.94 10.10 66 233381 77224 63178351
Joint destruction 121.73 10.10 132 233315 6120 63249455
Psoriasis 119.95 10.10 634 232813 86323 63169252
Drug ineffective 119.37 10.10 4829 228618 1039936 62215639
Musculoskeletal disorder 118.05 10.10 245 233202 20399 63235176
Sepsis 117.75 10.10 241 233206 152882 63102693
Pneumonia 117.73 10.10 1093 232354 455674 62799901
Toothache 117.07 10.10 234 233213 18965 63236610
Nerve injury 114.23 10.10 161 233286 9785 63245790
Grip strength decreased 114.22 10.10 253 233194 22034 63233541
Dislocation of vertebra 113.14 10.10 149 233298 8486 63247089
Pain 111.38 10.10 3533 229914 737095 62518480
Dyspnoea 106.65 10.10 1751 231696 659562 62596013
Musculoskeletal pain 105.63 10.10 640 232807 91637 63163938
Malignant neoplasm progression 105.56 10.10 88 233359 82033 63173542
Drug intolerance 100.32 10.10 1643 231804 307018 62948557
Drug interaction 99.08 10.10 469 232978 228662 63026913
Joint laxity 98.99 10.10 78 233369 2386 63253189
Mobility decreased 98.72 10.10 773 232674 120386 63135189
Gastric ulcer 97.35 10.10 249 233198 23788 63231787
Exposure during pregnancy 97.23 10.10 273 233174 155274 63100301
Cardiac failure congestive 97.15 10.10 118 233329 92315 63163260
Prescribed overdose 96.69 10.10 311 233136 33842 63221733
Systemic lupus erythematosus rash 96.36 10.10 74 233373 2178 63253397
Cholecystitis chronic 95.07 10.10 151 233296 10210 63245365
Drug tolerance 94.30 10.10 122 233325 6827 63248748
Multiple fractures 92.37 10.10 135 233312 8483 63247092
Loose body in joint 89.63 10.10 57 233390 1229 63254346
Nephrolithiasis 89.32 10.10 348 233099 41636 63213939
Bradycardia 88.65 10.10 83 233364 73144 63182431
Femur fracture 87.12 10.10 344 233103 41412 63214163
Dizziness 86.89 10.10 2131 231316 427794 62827781
Neck pain 84.62 10.10 489 232958 68829 63186746
Seronegative arthritis 83.11 10.10 87 233360 3872 63251703
Functional gastrointestinal disorder 83.05 10.10 90 233357 4169 63251406
Wound infection 80.78 10.10 216 233231 21194 63234381
Joint range of motion decreased 80.04 10.10 282 233165 32146 63223429
Wheelchair user 79.66 10.10 107 233340 6212 63249363
Blepharospasm 79.39 10.10 104 233343 5892 63249683
Platelet count decreased 77.71 10.10 197 233250 115925 63139650
Ear infection 75.09 10.10 309 233138 37904 63217671
Hypotension 73.72 10.10 644 232803 271960 62983615
Pseudoporphyria 73.19 10.10 28 233419 183 63255392
Maternal exposure during pregnancy 73.10 10.10 491 232956 219571 63036004
Osteoporosis 70.31 10.10 405 233042 56933 63198642
Renal impairment 69.66 10.10 137 233310 88218 63167357
Bursitis 69.25 10.10 295 233152 36746 63218829
Foetal exposure during pregnancy 67.68 10.10 17 233430 31945 63223630
Hypomagnesaemia 67.58 10.10 12 233435 28725 63226850
Tenosynovitis stenosans 67.20 10.10 72 233375 3292 63252283
Multiple organ dysfunction syndrome 66.75 10.10 66 233381 56686 63198889
Lip swelling 66.49 10.10 258 233189 30805 63224770
Dehydration 66.32 10.10 370 233077 172984 63082591
Mycotic allergy 66.03 10.10 43 233404 967 63254608
Cardiospasm 65.30 10.10 55 233392 1852 63253723
Tenosynovitis 64.47 10.10 151 233296 13644 63241931
Adjustment disorder with depressed mood 64.18 10.10 126 233321 10078 63245497
Amnesia 63.89 10.10 386 233061 55199 63200376
Drug abuse 63.85 10.10 105 233342 72413 63183162
Enthesopathy 63.69 10.10 114 233333 8500 63247075
Orthostatic hypotension 62.94 10.10 27 233420 36133 63219442
Palmoplantar keratoderma 62.86 10.10 55 233392 1952 63253623
Ulcer 62.69 10.10 225 233222 25882 63229693
Foot deformity 62.63 10.10 235 233212 27618 63227957
Respiratory failure 61.27 10.10 182 233265 101676 63153899
Liver injury 60.73 10.10 406 233041 60114 63195461
Premature delivery 60.56 10.10 18 233429 30263 63225312
Pruritus genital 60.56 10.10 61 233386 2593 63252982
Lip dry 60.32 10.10 158 233289 15312 63240263
Joint effusion 60.26 10.10 168 233279 16892 63238683
Bone density decreased 59.82 10.10 152 233295 14460 63241115
Hospitalisation 59.54 10.10 141 233306 84940 63170635
Synovial fluid analysis 59.37 10.10 58 233389 2375 63253200
Disability 59.30 10.10 175 233272 18172 63237403
Therapy non-responder 58.92 10.10 479 232968 75422 63180153
Drug tolerance decreased 58.72 10.10 169 233278 17304 63238271
Antibody test positive 57.74 10.10 60 233387 2647 63252928
Respiratory tract congestion 57.55 10.10 170 233277 17662 63237913
Neutrophil count decreased 57.18 10.10 74 233373 56332 63199243
Adrenal insufficiency 57.07 10.10 170 233277 17745 63237830
White blood cell count decreased 57.03 10.10 290 233157 138814 63116761
Facet joint syndrome 56.87 10.10 133 233314 12005 63243570
Gamma-glutamyltransferase increased 56.75 10.10 27 233420 34004 63221571
Renal failure 56.13 10.10 232 233215 117420 63138155
Red blood cell sedimentation rate increased 56.12 10.10 314 233133 43668 63211907
Red blood cell sedimentation rate 54.89 10.10 78 233369 4776 63250799
Hypoglycaemia 53.78 10.10 86 233361 59979 63195596
Impaired healing 53.59 10.10 595 232852 101947 63153628
Drug specific antibody 53.50 10.10 54 233393 2301 63253274
Deep vein thrombosis postoperative 52.64 10.10 124 233323 11245 63244330
Posterior reversible encephalopathy syndrome 51.62 10.10 3 233444 17342 63238233
Bunion operation 51.29 10.10 41 233406 1281 63254294
Constipation 51.24 10.10 554 232893 224389 63031186
Confusional state 51.15 10.10 589 232858 235791 63019784
Drug resistance 50.93 10.10 11 233436 22922 63232653
Intestinal diaphragm disease 50.73 10.10 18 233429 92 63255483
Neuropathy peripheral 50.06 10.10 231 233216 113436 63142139
Scleritis 49.85 10.10 71 233376 4357 63251218
Sleep terror 49.43 10.10 55 233392 2625 63252950
Juvenile idiopathic arthritis 49.26 10.10 61 233386 3265 63252310
Pleuritic pain 49.12 10.10 98 233349 7931 63247644
Hyperkalaemia 49.11 10.10 77 233370 54126 63201449
Device expulsion 47.93 10.10 35 233412 34887 63220688
Fear of injection 46.93 10.10 90 233357 7074 63248501
Peripheral swelling 46.84 10.10 1295 232152 264647 62990928
Peripheral venous disease 46.61 10.10 144 233303 15333 63240242
Limb discomfort 46.10 10.10 224 233223 29492 63226083
Pulmonary arterial hypertension 45.92 10.10 13 233434 22564 63233011
Neovascularisation 45.47 10.10 36 233411 1109 63254466
Nodule 44.48 10.10 174 233273 20852 63234723
Arthrodesis 44.13 10.10 53 233394 2748 63252827
Myelosuppression 44.04 10.10 16 233431 23687 63231888
Memory impairment 44.01 10.10 581 232866 103677 63151898
Colitis 43.90 10.10 69 233378 48459 63207116
Hypervolaemia 43.74 10.10 25 233422 28388 63227187
Wrist deformity 43.28 10.10 46 233401 2084 63253491
Neoplasm progression 43.25 10.10 42 233405 36386 63219189
Tendonitis 42.87 10.10 164 233283 19451 63236124
Respiratory distress 42.86 10.10 37 233410 33914 63221661
Sopor 42.85 10.10 14 233433 22150 63233425
Ascites 42.77 10.10 52 233395 40676 63214899
Pulmonary hypertension 42.70 10.10 44 233403 37079 63218496
Creatinine renal clearance decreased 42.55 10.10 5 233442 16303 63239272
Dysstasia 42.24 10.10 172 233275 20994 63234581
Synovial cyst 42.16 10.10 108 233339 10325 63245250
Osteoporotic fracture 42.07 10.10 60 233387 3686 63251889
Oedema 42.04 10.10 546 232901 97076 63158499
International normalised ratio increased 42.01 10.10 66 233381 46359 63209216
Hypoxia 41.90 10.10 99 233348 59693 63195882
Contraindicated product administered 41.80 10.10 1072 232375 216576 63038999
Paraesthesia 41.80 10.10 810 232637 156156 63099419
Autoimmune disorder 41.21 10.10 148 233299 17029 63238546
Emotional distress 40.61 10.10 231 233216 32318 63223257
Cerebrovascular accident 40.51 10.10 232 233215 107792 63147783
Immunisation 40.01 10.10 34 233413 1159 63254416
Uveitis 39.87 10.10 119 233328 12434 63243141
Angioedema 39.57 10.10 307 233140 47658 63207917
Hunger 39.53 10.10 71 233376 5308 63250267
Therapeutic response decreased 39.29 10.10 372 233075 61153 63194422
Gastric ulcer haemorrhage 38.94 10.10 67 233380 4841 63250734
Tension headache 38.81 10.10 69 233378 5117 63250458
Encephalopathy 38.80 10.10 51 233396 38569 63217006
Choanal stenosis 38.70 10.10 11 233436 22 63255553
Cardiac arrest 38.45 10.10 192 233255 92353 63163222
Therapeutic product effect decreased 38.42 10.10 956 232491 192231 63063344
Pulmonary congestion 38.37 10.10 146 233301 17272 63238303
Seizure 37.75 10.10 309 233138 132325 63123250
Pemphigus 36.97 10.10 465 232982 183261 63072314
Condition aggravated 36.86 10.10 1820 231627 400397 62855178
Swelling face 36.74 10.10 376 233071 63099 63192476
Deafness 36.70 10.10 147 233300 17810 63237765
Sedation complication 36.66 10.10 4 233443 13818 63241757
Electrolyte imbalance 36.55 10.10 14 233433 20062 63235513
Cartilage atrophy 36.42 10.10 16 233431 155 63255420
Off label use 36.29 10.10 2070 231377 672392 62583183
Acute respiratory failure 36.24 10.10 44 233403 34441 63221134
Bone disorder 36.18 10.10 165 233282 21161 63234414
Duodenal ulcer haemorrhage 36.15 10.10 45 233402 2422 63253153
Cytokine release syndrome 35.87 10.10 5 233442 14309 63241266
Dry mouth 35.87 10.10 441 233006 77422 63178153
Osteonecrosis of jaw 35.68 10.10 46 233401 35077 63220498
Syncope 35.49 10.10 269 233178 117116 63138459
Haematemesis 35.45 10.10 212 233235 30200 63225375
Walking aid user 35.38 10.10 103 233344 10614 63244961
Urticaria 35.23 10.10 828 232619 164974 63090601
Rheumatoid lung 35.19 10.10 56 233391 3792 63251783
Right ventricular failure 34.77 10.10 10 233437 17178 63238397
Abnormal loss of weight 34.68 10.10 70 233377 5712 63249863
Carotid artery occlusion 34.55 10.10 62 233385 4632 63250943
Hepatic function abnormal 34.37 10.10 52 233395 37090 63218485
Premature baby 33.74 10.10 17 233430 20718 63234857
Feeding disorder 33.66 10.10 117 233330 13245 63242330
Cerebral haemorrhage 33.59 10.10 38 233409 30691 63224884
Myelodysplastic syndrome 33.43 10.10 10 233437 16744 63238831
Electrocardiogram QT prolonged 33.23 10.10 110 233337 59420 63196155
Iritis 32.96 10.10 49 233398 3126 63252449
Tooth infection 32.93 10.10 142 233305 17778 63237797
Hyperglycaemia 32.92 10.10 65 233382 41802 63213773
Blood creatine phosphokinase increased 32.86 10.10 38 233409 30392 63225183
Macular degeneration 32.72 10.10 25 233422 24351 63231224
Mucosal inflammation 32.64 10.10 78 233369 46850 63208725
Atrial fibrillation 32.61 10.10 273 233174 116363 63139212
Dactylitis 32.57 10.10 44 233403 2568 63253007
Alanine aminotransferase abnormal 32.52 10.10 59 233388 4445 63251130
Tenderness 32.06 10.10 166 233281 22412 63233163
Fracture delayed union 32.05 10.10 42 233405 2380 63253195
Psychotic disorder 31.28 10.10 29 233418 25683 63229892
Blood parathyroid hormone decreased 31.27 10.10 93 233354 9698 63245877
Atrial tachycardia 31.20 10.10 56 233391 4184 63251391
Hepatic cytolysis 31.10 10.10 9 233438 15398 63240177
Feeling jittery 30.90 10.10 114 233333 13289 63242286
Neurotoxicity 30.68 10.10 12 233435 16978 63238597
Soft tissue injury 30.63 10.10 34 233413 1618 63253957
Palmar-plantar erythrodysaesthesia syndrome 30.39 10.10 24 233423 22991 63232584
Blood creatinine increased 30.14 10.10 194 233253 87650 63167925
Knee arthroplasty 29.90 10.10 318 233129 53888 63201687
Tachycardia 29.77 10.10 284 233163 117872 63137703
Acute kidney injury 29.77 10.10 739 232708 262676 62992899
Plasma cell myeloma 29.76 10.10 54 233393 35851 63219724
Full blood count decreased 29.76 10.10 31 233416 25993 63229582
Ankle arthroplasty 29.71 10.10 35 233412 1778 63253797
Taste disorder 29.67 10.10 114 233333 13548 63242027
Tongue disorder 29.63 10.10 96 233351 10484 63245091
Disability assessment scale score increased 29.50 10.10 47 233400 3186 63252389
Pain of skin 29.42 10.10 102 233345 11532 63244043
Infection 29.31 10.10 1074 232373 228099 63027476
Serum sickness-like reaction 29.22 10.10 20 233427 490 63255085
Bone marrow failure 29.09 10.10 39 233408 29251 63226324
Wrong technique in product usage process 29.06 10.10 124 233323 62216 63193359
Chronic obstructive pulmonary disease 29.03 10.10 125 233322 62561 63193014
Oedema peripheral 28.99 10.10 506 232941 189005 63066570
Product dose omission issue 28.79 10.10 649 232798 233664 63021911
Agranulocytosis 28.67 10.10 30 233417 25104 63230471
Smear cervix abnormal 28.51 10.10 44 233403 2902 63252673
Weight decreased 28.42 10.10 1267 232180 275531 62980044
Gastrooesophageal reflux disease 28.39 10.10 502 232945 95137 63160438
Limb deformity 28.36 10.10 52 233395 3950 63251625
Metastases to liver 28.36 10.10 27 233420 23612 63231963
Clear cell renal cell carcinoma 28.29 10.10 31 233416 1454 63254121
Balance disorder 28.17 10.10 188 233259 84234 63171341
Photophobia 28.12 10.10 134 233313 17501 63238074
Short stature 28.06 10.10 22 233425 668 63254907
Acute myeloid leukaemia 27.99 10.10 14 233433 17133 63238442
Oesophageal spasm 27.95 10.10 45 233402 3078 63252497
Systemic lupus erythematosus 27.89 10.10 571 232876 208347 63047228
Sacroiliitis 27.88 10.10 46 233401 3211 63252364
Granuloma skin 27.77 10.10 81 233366 8356 63247219
Clostridium difficile colitis 27.73 10.10 21 233426 20548 63235027
Allergy to chemicals 27.45 10.10 44 233403 2998 63252577
Drug eruption 27.29 10.10 190 233257 28504 63227071
Tooth disorder 27.11 10.10 187 233260 27970 63227605
Device related infection 26.60 10.10 28 233419 23364 63232211
Breast cancer stage III 26.21 10.10 91 233356 10295 63245280
Drug reaction with eosinophilia and systemic symptoms 26.20 10.10 53 233394 33783 63221792
Urosepsis 26.16 10.10 18 233429 18506 63237069
Urinary tract infection 26.13 10.10 757 232690 263927 62991648
Hypokalaemia 25.94 10.10 250 233197 103554 63152021
Haematoma 25.74 10.10 56 233391 34764 63220811
Hallucination, visual 25.64 10.10 20 233427 19278 63236297
Immunodeficiency 25.43 10.10 144 233303 20110 63235465
Biliary dyskinesia 25.35 10.10 40 233407 2689 63252886
Blood pressure measurement 25.21 10.10 15 233432 286 63255289
Back pain 25.15 10.10 1200 232247 262945 62992630
Full blood count abnormal 25.14 10.10 49 233398 31668 63223907
Intestinal obstruction 25.14 10.10 47 233400 30852 63224723
Hip arthroplasty 25.12 10.10 277 233170 47369 63208206
No adverse event 24.87 10.10 74 233373 41331 63214244
Quality of life decreased 24.76 10.10 80 233367 8723 63246852
Panniculitis 24.72 10.10 95 233352 11290 63244285
Hepatocellular injury 24.70 10.10 39 233408 27342 63228233
Antinuclear antibody positive 24.62 10.10 75 233372 7924 63247651
Rales 24.58 10.10 8 233439 12689 63242886
Adverse reaction 24.55 10.10 88 233359 10115 63245460
Skin ulcer 24.44 10.10 254 233193 42791 63212784
Neuroleptic malignant syndrome 24.41 10.10 7 233440 12049 63243526
Myofascial pain syndrome 24.39 10.10 36 233411 2282 63253293
Joint injury 24.23 10.10 189 233258 29383 63226192
Gallbladder injury 24.20 10.10 28 233419 1395 63254180
Bone density increased 24.20 10.10 21 233426 737 63254838
Malaise 24.12 10.10 1808 231639 414146 62841429
Osteoarthritis 24.02 10.10 488 232959 94855 63160720
Renal mass 23.98 10.10 36 233411 2317 63253258
Hepatotoxicity 23.88 10.10 64 233383 36977 63218598
Anosmia 23.68 10.10 67 233380 6793 63248782
Upper gastrointestinal haemorrhage 23.65 10.10 134 233313 18718 63236857
Oesophageal pain 23.64 10.10 46 233401 3655 63251920
Night sweats 23.58 10.10 279 233168 48535 63207040
Dysphagia 23.58 10.10 210 233237 88375 63167200
Cerebral infarction 23.54 10.10 32 233415 23861 63231714
Spinal fusion surgery 23.51 10.10 59 233388 5569 63250006
Cardio-respiratory arrest 23.44 10.10 127 233320 59832 63195743
C-reactive protein 23.43 10.10 54 233393 4828 63250747
Cardiogenic shock 23.30 10.10 19 233428 17913 63237662
Blood alkaline phosphatase increased 22.89 10.10 81 233366 42886 63212689
Bone lesion 22.86 10.10 60 233387 5821 63249754
Body temperature decreased 22.64 10.10 140 233307 20179 63235396
Transfusion 22.56 10.10 14 233433 15203 63240372
Aorta hypoplasia 22.54 10.10 11 233436 138 63255437
Pericardial effusion 22.50 10.10 48 233399 30010 63225565
Left ventricular dysfunction 22.43 10.10 8 233439 11980 63243595
Sensitivity to weather change 22.41 10.10 68 233379 7169 63248406
Diabetes mellitus inadequate control 22.31 10.10 14 233433 15112 63240463
Premature labour 22.30 10.10 9 233438 12495 63243080
Sciatica 22.14 10.10 208 233239 34116 63221459
Musculoskeletal discomfort 22.07 10.10 127 233320 17840 63237735
Cholestasis 22.03 10.10 47 233400 29387 63226188
Oesophageal ulcer 21.92 10.10 50 233397 4440 63251135
Synovial disorder 21.87 10.10 32 233415 2013 63253562
Prescribed underdose 21.76 10.10 185 233262 29504 63226071
Blood calcium decreased 21.73 10.10 40 233407 26411 63229164
Crepitations 21.66 10.10 72 233375 7968 63247607
Swollen joint count increased 21.54 10.10 215 233232 35839 63219736
Depressed level of consciousness 21.34 10.10 137 233310 61941 63193634
Facial pain 21.22 10.10 86 233361 10475 63245100
Ileus 21.21 10.10 14 233433 14711 63240864
Metastases to bone 20.86 10.10 28 233419 20991 63234584
Acute respiratory distress syndrome 20.78 10.10 34 233413 23500 63232075
Medication overuse headache 20.61 10.10 20 233427 812 63254763
Bacteraemia 20.60 10.10 20 233427 17328 63238247
Blood sodium decreased 20.53 10.10 36 233411 24216 63231359
Bronchospasm 20.42 10.10 20 233427 17260 63238315
Blood cholesterol increased 20.39 10.10 471 232976 93561 63162014
Dyspepsia 20.37 10.10 506 232941 101690 63153885
Goitre 20.36 10.10 58 233389 5903 63249672
Joint ankylosis 20.21 10.10 22 233425 1024 63254551
Lower respiratory tract infection 20.18 10.10 633 232814 131674 63123901
Flank pain 20.17 10.10 116 233331 16294 63239281
Skin necrosis 20.11 10.10 103 233344 13847 63241728
Red blood cell count decreased 19.94 10.10 233 233214 40412 63215163
Bronchiectasis 19.88 10.10 18 233429 16124 63239451
Aspergillus infection 19.88 10.10 3 233444 8090 63247485
Collagen-vascular disease 19.81 10.10 9 233438 95 63255480
Caesarean section 19.80 10.10 20 233427 17012 63238563
Intentional product use issue 19.80 10.10 613 232834 127279 63128296
Pharyngeal swelling 19.67 10.10 60 233387 6344 63249231
Blood potassium increased 19.62 10.10 23 233424 18286 63237289
Endocarditis fibroplastica 19.60 10.10 5 233442 5 63255570
Type 2 diabetes mellitus 19.58 10.10 337 233110 63531 63192044
Device ineffective 19.57 10.10 12 233435 242 63255333
Cyanosis 19.56 10.10 20 233427 16915 63238660
Adenoiditis 19.53 10.10 7 233440 37 63255538
Polyneuropathy 19.53 10.10 15 233432 14574 63241001
Therapy interrupted 19.50 10.10 58 233389 32397 63223178
Therapy cessation 19.35 10.10 53 233394 30404 63225171
Rash pruritic 19.23 10.10 318 233129 59481 63196094
Hodgkin's disease 19.21 10.10 19 233428 790 63254785
Loss of personal independence in daily activities 19.18 10.10 481 232966 96809 63158766
Gastroenteritis viral 19.16 10.10 151 233296 23549 63232026
Blood bilirubin increased 19.13 10.10 71 233376 37069 63218506
Pancreatitis 19.12 10.10 104 233343 48951 63206624
Epistaxis 19.09 10.10 173 233274 72552 63183023
Circulatory collapse 19.08 10.10 32 233415 21906 63233669
Allodynia 19.01 10.10 19 233428 800 63254775
Arrhythmia 18.94 10.10 74 233373 38066 63217509
Heart rate 18.91 10.10 8 233439 70 63255505
Paradoxical drug reaction 18.91 10.10 45 233402 4107 63251468
Jejunal ulcer 18.87 10.10 9 233438 107 63255468
Cardiotoxicity 18.83 10.10 4 233443 8434 63247141
Hepatic encephalopathy 18.73 10.10 9 233438 11273 63244302
Hypoalbuminaemia 18.73 10.10 10 233437 11795 63243780
Limb operation 18.70 10.10 44 233403 3987 63251588
Diabetic ketoacidosis 18.69 10.10 29 233418 20476 63235099
Tumour lysis syndrome 18.61 10.10 5 233442 8985 63246590
Skin papilloma 18.61 10.10 50 233397 4919 63250656
Feeling abnormal 18.61 10.10 694 232753 147698 63107877
Hepatic adenoma 18.59 10.10 13 233434 330 63255245
Atelectasis 18.55 10.10 139 233308 21344 63234231
Metastases to lung 18.53 10.10 12 233435 12738 63242837
Chronic spontaneous urticaria 18.40 10.10 22 233425 1135 63254440
Wheezing 18.37 10.10 471 232976 95124 63160451
Joint noise 18.30 10.10 46 233401 4346 63251229
Fall 18.24 10.10 1220 232227 391114 62864461
Obstructive airways disorder 18.19 10.10 30 233417 20669 63234906
Eosinophilia 18.17 10.10 35 233412 22721 63232854
Cytopenia 18.15 10.10 10 233437 11591 63243984
Blood potassium decreased 18.14 10.10 86 233361 41940 63213635
Drug level increased 18.13 10.10 35 233412 22701 63232874
Tendon rupture 18.09 10.10 69 233378 8170 63247405
Rheumatic fever 18.08 10.10 240 233207 42871 63212704
Finger deformity 17.96 10.10 66 233381 7679 63247896
Lactic acidosis 17.94 10.10 76 233371 38211 63217364
Anti-transglutaminase antibody 17.93 10.10 5 233442 9 63255566
Cardiomyopathy 17.89 10.10 23 233424 17561 63238014
Breath sounds abnormal 17.85 10.10 9 233438 10964 63244611
Parkinsonism 17.84 10.10 8 233439 10431 63245144
Kidney infection 17.83 10.10 146 233301 23030 63232545
Human anti-human antibody test 17.83 10.10 14 233433 426 63255149
Spondyloarthropathy 17.75 10.10 19 233428 868 63254707
Malnutrition 17.74 10.10 18 233429 15280 63240295
Laboratory test abnormal 17.72 10.10 46 233401 26866 63228709
Eosinophil count increased 17.72 10.10 9 233438 10919 63244656
Haemorrhage intracranial 17.71 10.10 14 233433 13405 63242170
Subdural haematoma 17.62 10.10 16 233431 14312 63241263
Aspirin-exacerbated respiratory disease 17.60 10.10 19 233428 876 63254699
Lymphopenia 17.60 10.10 25 233422 18302 63237273
Pleural effusion 17.60 10.10 239 233208 92971 63162604
Bronchopulmonary aspergillosis 17.51 10.10 5 233442 8630 63246945
Nerve compression 17.47 10.10 73 233374 9014 63246561
Endometriosis 17.44 10.10 51 233396 5269 63250306
Pulmonary oedema 17.41 10.10 124 233323 54749 63200826
Blood pressure diastolic increased 17.39 10.10 78 233369 9932 63245643
Hepatic cirrhosis 17.29 10.10 41 233406 24693 63230882
COVID-19 17.28 10.10 302 233145 112801 63142774
Metastases to fallopian tube 17.20 10.10 7 233440 55 63255520
Glossodynia 17.04 10.10 514 232933 178362 63077213
Glomerulonephritis minimal lesion 17.02 10.10 11 233436 244 63255331
Sinus bradycardia 17.02 10.10 17 233430 14534 63241041
Enterocolitis 16.99 10.10 4 233443 7854 63247721
Dyspnoea exertional 16.91 10.10 141 233306 60161 63195414
Radiation associated pain 16.86 10.10 8 233439 94 63255481
Gait disturbance 16.75 10.10 829 232618 182349 63073226
Ischaemic stroke 16.75 10.10 25 233422 17932 63237643
Blood urea increased 16.68 10.10 46 233401 26333 63229242
Deformity 16.65 10.10 86 233361 11598 63243977
Sputum discoloured 16.59 10.10 110 233337 16237 63239338
Oral candidiasis 16.57 10.10 37 233410 22761 63232814
Adrenergic syndrome 16.55 10.10 6 233441 33 63255542
Anaphylactic reaction 16.54 10.10 338 233109 65762 63189813
Schizophrenia 16.43 10.10 8 233439 9944 63245631
Blood albumin decreased 16.42 10.10 18 233429 14748 63240827
Amblyopia 16.41 10.10 11 233436 260 63255315
Aggression 16.38 10.10 39 233408 23459 63232116
Unevaluable event 16.36 10.10 116 233331 51270 63204305
Duodenal ulcer 16.25 10.10 64 233383 7692 63247883
HLA marker study positive 16.25 10.10 10 233437 203 63255372
Cushingoid 16.18 10.10 68 233379 8417 63247158
Ventricular fibrillation 16.15 10.10 12 233435 11855 63243720
Eye pain 16.13 10.10 193 233254 33661 63221914
Breast cancer stage I 15.93 10.10 3 233444 6886 63248689
Unresponsive to stimuli 15.92 10.10 67 233380 33749 63221826
Staphylococcal infection 15.79 10.10 88 233359 41168 63214407
Libido increased 15.78 10.10 22 233425 1323 63254252
Gallbladder cholesterolosis 15.66 10.10 17 233430 789 63254786
Blood lactate dehydrogenase increased 15.62 10.10 39 233408 23077 63232498
Pre-eclampsia 15.61 10.10 7 233440 9126 63246449
Abdominal pain 15.57 10.10 1267 232180 292189 62963386
Complication associated with device 15.49 10.10 24 233423 16954 63238621
Anomaly of external ear congenital 15.48 10.10 9 233438 164 63255411
Status epilepticus 15.42 10.10 20 233427 15213 63240362
Mental status changes 15.41 10.10 84 233363 39515 63216060
Pemphigoid 15.37 10.10 4 233443 7340 63248235
Pneumocystis jirovecii pneumonia 15.34 10.10 24 233423 16890 63238685
Vascular device infection 15.27 10.10 4 233443 7308 63248267
Nail dystrophy 15.24 10.10 19 233428 1024 63254551
Accidental overdose 15.23 10.10 40 233407 23269 63232306
Lip oedema 15.22 10.10 40 233407 3884 63251691
IIIrd nerve injury 15.21 10.10 4 233443 5 63255570
Nail psoriasis 15.12 10.10 15 233432 626 63254949
Fixed eruption 15.12 10.10 20 233427 1144 63254431
Skin fissures 14.99 10.10 82 233365 11306 63244269
Sudden death 14.96 10.10 10 233437 10439 63245136
Depression 14.93 10.10 874 232573 195618 63059957
Clostridium difficile infection 14.89 10.10 58 233389 29864 63225711
Normal newborn 14.88 10.10 6 233441 8335 63247240
Adverse drug reaction 14.80 10.10 391 233056 79323 63176252
Hypothyroidism 14.69 10.10 94 233353 42538 63213037
Fine motor skill dysfunction 14.63 10.10 45 233402 4780 63250795
Product label confusion 14.62 10.10 25 233422 1797 63253778
Spondylitis 14.52 10.10 42 233405 4312 63251263
Blood pressure systolic increased 14.49 10.10 250 233197 47147 63208428
Blood pressure decreased 14.44 10.10 161 233286 64861 63190714
Vaginal stricture 14.42 10.10 4 233443 7 63255568
Myopathy 14.36 10.10 12 233435 11179 63244396
Tachypnoea 14.36 10.10 26 233421 17276 63238299
Infusion site pain 14.31 10.10 25 233422 16844 63238731
Blood pressure diastolic abnormal 14.25 10.10 97 233350 14445 63241130
Vaginal infection 14.14 10.10 60 233387 7458 63248117
Haematocrit decreased 14.09 10.10 213 233234 39127 63216448
Costovertebral angle tenderness 14.06 10.10 7 233440 92 63255483
Shock 14.04 10.10 42 233405 23421 63232154
Gastric disorder 14.03 10.10 204 233243 37165 63218410
Oliguria 14.02 10.10 8 233439 9093 63246482
Injection site reaction 13.90 10.10 297 233150 58227 63197348
Foetal death 13.82 10.10 12 233435 10968 63244607
Road traffic accident 13.77 10.10 200 233247 36432 63219143
Onychomadesis 13.74 10.10 50 233397 5790 63249785
Faecaloma 13.71 10.10 6 233441 7935 63247640
Pulmonary fibrosis 13.66 10.10 214 233233 39595 63215980
Asphyxia 13.65 10.10 3 233444 6178 63249397
Periorbital oedema 13.65 10.10 49 233398 5635 63249940
Meningitis streptococcal 13.61 10.10 8 233439 149 63255426
Red cell distribution width decreased 13.60 10.10 26 233421 2039 63253536
Lupus-like syndrome 13.59 10.10 22 233425 15273 63240302
Stress cardiomyopathy 13.59 10.10 9 233438 9441 63246134
Acquired cystic kidney disease 13.49 10.10 6 233441 60 63255515
Aspartate aminotransferase increased 13.48 10.10 242 233205 90035 63165540
Genitourinary symptom 13.32 10.10 6 233441 62 63255513
Cholesterosis 13.32 10.10 12 233435 443 63255132
Supraventricular tachycardia 13.19 10.10 20 233427 14251 63241324
Sleep disorder 13.17 10.10 393 233054 81173 63174402
Limb asymmetry 13.10 10.10 16 233431 844 63254731
Hypophagia 13.10 10.10 174 233273 31085 63224490
Tooth hypoplasia 13.07 10.10 6 233441 65 63255510
Hypovolaemia 13.03 10.10 12 233435 10661 63244914
Anal abscess 12.94 10.10 42 233405 4590 63250985
Muscle spasms 12.92 10.10 700 232747 155450 63100125
Tendon disorder 12.89 10.10 49 233398 5794 63249781
Therapeutic product effect variable 12.88 10.10 19 233428 1204 63254371
Hostility 12.86 10.10 24 233423 1848 63253727
Troponin increased 12.81 10.10 11 233436 10110 63245465
Generalised tonic-clonic seizure 12.74 10.10 59 233388 28957 63226618
Muscle twitching 12.59 10.10 119 233328 19549 63236026
Spinal cord infection 12.53 10.10 14 233433 671 63254904
Spleen congestion 12.52 10.10 7 233440 118 63255457
Epstein-Barr virus infection 12.51 10.10 7 233440 8043 63247532
Anxiety 12.48 10.10 945 232502 216596 63038979
Lymphocyte count decreased 12.43 10.10 63 233384 30194 63225381
Cardiac disorder 12.43 10.10 123 233324 50693 63204882
Dialysis 12.40 10.10 12 233435 10415 63245160
Blood pressure systolic abnormal 12.36 10.10 88 233359 13298 63242277
Pneumonia bacterial 12.33 10.10 10 233437 9455 63246120
Hemiparesis 12.33 10.10 44 233403 23238 63232337
Post-traumatic neck syndrome 12.31 10.10 25 233422 2049 63253526
Alanine aminotransferase increased 12.28 10.10 289 233158 103481 63152094
Lipase increased 12.24 10.10 11 233436 9889 63245686
Labelled drug-drug interaction medication error 12.17 10.10 19 233428 13380 63242195
Myoclonus 12.16 10.10 25 233422 15843 63239732
Pseudomonas infection 12.11 10.10 14 233433 11199 63244376
Left ventricular failure 12.09 10.10 3 233444 5684 63249891
Single umbilical artery 12.07 10.10 9 233438 253 63255322
Pancreatitis acute 12.07 10.10 55 233392 27111 63228464
Rash 11.93 10.10 2287 231160 558584 62696991
Spinal pain 11.91 10.10 86 233361 13053 63242522
Lipidosis 11.90 10.10 5 233442 43 63255532
Muscular weakness 11.87 10.10 557 232890 121796 63133779
Head injury 11.86 10.10 56 233391 27340 63228235
Oropharyngeal oedema 11.82 10.10 10 233437 339 63255236
Accidental exposure to product by child 11.80 10.10 18 233429 1175 63254400
Hypertensive crisis 11.79 10.10 24 233423 15262 63240313
Wrong product procured 11.76 10.10 3 233444 3 63255572
Colostomy infection 11.76 10.10 3 233444 3 63255572
Headache 11.75 10.10 2565 230882 630676 62624899
Mania 11.75 10.10 17 233430 12350 63243225
Restlessness 11.72 10.10 62 233385 29391 63226184
Sedation 11.69 10.10 89 233358 38720 63216855
Atrioventricular block complete 11.68 10.10 8 233439 8243 63247332
Metastases to central nervous system 11.51 10.10 19 233428 13086 63242489
Colitis ulcerative 11.49 10.10 53 233394 26038 63229537
Wound 11.47 10.10 487 232960 162776 63092799
Toxicity to various agents 11.44 10.10 769 232678 246481 63009094
Vaginal abscess 11.39 10.10 11 233436 444 63255131
Staphylococcal sepsis 11.34 10.10 8 233439 8120 63247455
Hyperthyroidism 11.34 10.10 23 233424 14650 63240925
Pregnancy 11.32 10.10 84 233363 36752 63218823
Blood pressure fluctuation 11.31 10.10 236 233211 46081 63209494
Oesophageal atresia 11.30 10.10 12 233435 543 63255032
Aphasia 11.25 10.10 73 233374 32927 63222648
Hepatic enzyme abnormal 11.25 10.10 50 233397 6342 63249233
Polymenorrhagia 11.24 10.10 5 233442 50 63255525
Aspiration 11.24 10.10 14 233433 10837 63244738
COVID-19 pneumonia 11.22 10.10 22 233425 14187 63241388
Frequent bowel movements 11.22 10.10 45 233402 22977 63232598
Glaucoma 11.20 10.10 34 233413 18871 63236704
Lung disorder 11.16 10.10 304 233143 61957 63193618
Torsade de pointes 11.13 10.10 20 233427 13331 63242244
Parakeratosis 11.13 10.10 9 233438 286 63255289
Lower limb fracture 11.07 10.10 137 233310 24084 63231491
Septic arthritis staphylococcal 11.03 10.10 11 233436 462 63255113
Lip and/or oral cavity cancer 11.01 10.10 15 233432 883 63254692
Dementia 10.99 10.10 34 233413 18760 63236815
Basal cell carcinoma 10.99 10.10 154 233293 27837 63227738
Pseudodementia 10.96 10.10 6 233441 97 63255478
Bradyphrenia 10.95 10.10 6 233441 6974 63248601
Proteinuria 10.94 10.10 35 233412 19110 63236465
Transaminases increased 10.89 10.10 69 233378 31298 63224277
Sternal fracture 10.89 10.10 25 233422 2229 63253346
Gastrointestinal submucosal tumour 10.88 10.10 4 233443 23 63255552
Inflammatory pain 10.83 10.10 15 233432 897 63254678
Maternal drugs affecting foetus 10.70 10.10 3 233444 5239 63250336
Compartment syndrome 10.67 10.10 25 233422 2259 63253316
Infective pulmonary exacerbation of cystic fibrosis 10.66 10.10 10 233437 8807 63246768
Metabolic encephalopathy 10.66 10.10 4 233443 5805 63249770
Brain natriuretic peptide increased 10.61 10.10 3 233444 5210 63250365
Trigger finger 10.59 10.10 38 233409 4370 63251205
Poor quality sleep 10.55 10.10 116 233331 19819 63235756
Blood glucose increased 10.55 10.10 231 233216 83525 63172050
Sleep disorder due to general medical condition, insomnia type 10.55 10.10 132 233315 52085 63203490
Generalised oedema 10.45 10.10 27 233420 15791 63239784
Spinal osteoarthritis 10.39 10.10 98 233349 16088 63239487
Congenital choroid plexus cyst 10.37 10.10 9 233438 316 63255259
Plantar fasciitis 10.34 10.10 34 233413 3741 63251834
Progressive multifocal leukoencephalopathy 10.31 10.10 20 233427 12951 63242624
Food aversion 10.30 10.10 14 233433 822 63254753
Haemorrhage 10.28 10.10 160 233287 60862 63194713
Tremor 10.24 10.10 390 233057 131849 63123726
Failure of child resistant product closure 10.22 10.10 4 233443 28 63255547
Retinitis 10.20 10.10 5 233442 6191 63249384
Diffuse large B-cell lymphoma 10.20 10.10 6 233441 6706 63248869
Dysmenorrhoea 10.19 10.10 35 233412 3938 63251637
Cytomegalovirus viraemia 10.18 10.10 4 233443 5645 63249930
Cardiac failure acute 10.17 10.10 12 233435 9511 63246064
Failure to thrive 10.16 10.10 7 233440 7191 63248384
Musculoskeletal deformity 10.15 10.10 22 233425 1887 63253688
Toxic skin eruption 10.13 10.10 20 233427 12865 63242710
Altered state of consciousness 10.10 10.10 53 233394 25177 63230398

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 379.06 10.85 206 79775 5398 34871552
Gastric haemorrhage 249.99 10.85 199 79782 10062 34866888
Arthralgia 242.98 10.85 897 79084 169144 34707806
Psoriatic arthropathy 231.22 10.85 255 79726 19543 34857407
Joint swelling 208.57 10.85 438 79543 59452 34817498
Musculoskeletal stiffness 203.23 10.85 375 79606 46305 34830645
Duodenal ulcer 199.11 10.85 175 79806 10157 34866793
Pain 182.57 10.85 937 79044 203738 34673212
Psoriasis 143.45 10.85 291 79690 38521 34838429
Lip swelling 131.72 10.85 173 79808 15907 34861043
Death 130.38 10.85 471 79510 397578 34479372
Upper gastrointestinal haemorrhage 129.07 10.85 219 79762 25299 34851651
Cardiospasm 129.03 10.85 66 79915 1522 34875428
Neutropenia 123.89 10.85 106 79875 156672 34720278
Palmoplantar keratoderma 113.52 10.85 65 79916 1888 34875062
Pruritus genital 111.38 10.85 67 79914 2137 34874813
Acne cystic 109.36 10.85 42 79939 472 34876478
Sleep terror 105.73 10.85 66 79915 2252 34874698
Febrile neutropenia 103.91 10.85 96 79885 136753 34740197
Gastrointestinal haemorrhage 103.61 10.85 439 79542 88038 34788912
Off label use 99.12 10.85 560 79421 418964 34457986
Melaena 98.70 10.85 237 79744 35143 34841807
Tension headache 98.57 10.85 70 79911 2972 34873978
Angioedema 98.56 10.85 245 79736 37129 34839821
Rheumatoid arthritis 92.88 10.85 243 79738 37995 34838955
Carotid artery occlusion 92.13 10.85 73 79908 3664 34873286
Migraine 91.03 10.85 152 79829 17326 34859624
Anosmia 89.46 10.85 74 79907 3950 34873000
Facial pain 88.42 10.85 71 79910 3633 34873317
Immunisation 88.19 10.85 45 79936 1032 34875918
Gastric ulcer 88.13 10.85 141 79840 15509 34861441
Atrial tachycardia 87.29 10.85 70 79911 3575 34873375
Congenital hiatus hernia 86.22 10.85 41 79940 803 34876147
Pancytopenia 76.74 10.85 63 79918 95094 34781856
Eye pruritus 76.45 10.85 90 79891 7399 34869551
Arthritis 75.91 10.85 199 79782 31147 34845803
Duodenal ulcer haemorrhage 75.46 10.85 74 79907 4939 34872011
Thrombocytopenia 74.91 10.85 153 79828 156094 34720856
Pain in extremity 73.83 10.85 519 79462 125994 34750956
Back pain 73.65 10.85 504 79477 121285 34755665
Sepsis 71.74 10.85 173 79808 166388 34710562
Transient ischaemic attack 71.72 10.85 180 79801 27433 34849517
Milk-alkali syndrome 69.89 10.85 32 79949 573 34876377
Abdominal discomfort 69.31 10.85 296 79685 59539 34817411
Sacroiliitis 69.20 10.85 43 79938 1455 34875495
Peripheral swelling 65.60 10.85 347 79634 76194 34800756
Pain of skin 63.33 10.85 74 79907 6035 34870915
IgM nephropathy 63.29 10.85 20 79961 118 34876832
Neck pain 62.47 10.85 162 79819 25187 34851763
Cardiac failure 62.40 10.85 70 79911 91178 34785772
Pneumonia 61.38 10.85 533 79448 362094 34514856
Completed suicide 60.36 10.85 408 79573 97760 34779190
Faeces discoloured 60.30 10.85 116 79865 14762 34862188
Gastric ulcer haemorrhage 57.98 10.85 67 79914 5399 34871551
Pericarditis 57.62 10.85 99 79882 11546 34865404
Synovitis 54.97 10.85 108 79873 13958 34862992
Joint injury 54.90 10.85 85 79896 9088 34867862
Haematemesis 53.44 10.85 162 79819 27549 34849401
Leukopenia 52.70 10.85 40 79941 62816 34814134
Septic shock 52.59 10.85 52 79929 71782 34805168
Atrial fibrillation 50.42 10.85 130 79851 122263 34754687
Enthesopathy 49.70 10.85 57 79924 4556 34872394
Peptic ulcer 49.37 10.85 45 79936 2738 34874212
Muscle twitching 48.93 10.85 86 79895 10212 34866738
Grip strength decreased 46.25 10.85 46 79935 3123 34873827
Tinnitus 44.95 10.85 124 79857 19994 34856956
Disability 43.32 10.85 54 79927 4711 34872239
C-reactive protein abnormal 43.03 10.85 74 79907 8636 34868314
Osteoarthritis 42.96 10.85 124 79857 20518 34856432
Duodenal ulcer perforation 42.65 10.85 33 79948 1599 34875351
Cytomegalovirus infection 42.41 10.85 5 79976 26130 34850820
General physical health deterioration 42.26 10.85 151 79830 128118 34748832
Insomnia 41.42 10.85 391 79590 103516 34773434
Bradycardia 39.47 10.85 70 79911 75348 34801602
Musculoskeletal discomfort 37.85 10.85 67 79914 8001 34868949
Disease progression 37.79 10.85 124 79857 107953 34768997
Abdominal pain upper 37.47 10.85 286 79695 71204 34805746
Product used for unknown indication 37.46 10.85 25 79956 958 34875992
Drug resistance 37.38 10.85 7 79974 25920 34851030
Drug interaction 37.27 10.85 334 79647 225612 34651338
Hypoglycaemia 37.25 10.85 42 79939 54598 34822352
Muscle swelling 36.97 10.85 18 79963 372 34876578
Vasculitis 36.26 10.85 80 79901 11216 34865734
Anxiety 35.65 10.85 366 79615 99062 34777888
Rash papular 35.52 10.85 75 79906 10203 34866747
Ascites 34.91 10.85 33 79948 46538 34830412
Withdrawal arrhythmia 34.82 10.85 10 79971 40 34876910
Hyponatraemia 34.67 10.85 87 79894 82604 34794346
Hospitalisation 34.34 10.85 48 79933 56854 34820096
Product use in unapproved indication 33.80 10.85 146 79835 117353 34759597
Arthropathy 33.39 10.85 136 79845 26771 34850179
Hypokalaemia 33.28 10.85 51 79930 58163 34818787
Gastrointestinal ulcer 32.99 10.85 29 79952 1682 34875268
Malignant melanoma in situ 32.75 10.85 29 79952 1699 34875251
Gastritis 32.44 10.85 117 79864 21756 34855194
Musculoskeletal disorder 32.36 10.85 54 79927 6150 34870800
Seronegative arthritis 31.58 10.85 23 79958 1016 34875934
Gastritis erosive 31.43 10.85 52 79929 5880 34871070
Discomfort 31.29 10.85 105 79876 18833 34858117
Accidental exposure to product by child 30.45 10.85 26 79955 1450 34875500
Diplopia 30.18 10.85 96 79885 16747 34860203
Neutrophil count decreased 29.96 10.85 44 79937 51060 34825890
Hyperhidrosis 29.73 10.85 284 79697 75408 34801542
Platelet count decreased 29.62 10.85 157 79824 119560 34757390
Renal papillary necrosis 29.40 10.85 12 79969 160 34876790
Subarachnoid haemorrhage 29.34 10.85 79 79902 12556 34864394
Drug hypersensitivity 29.13 10.85 297 79684 80232 34796718
Spinal osteoarthritis 28.83 10.85 58 79923 7625 34869325
Lymphocyte count abnormal 28.67 10.85 23 79958 1175 34875775
Pseudoporphyria 28.52 10.85 15 79966 367 34876583
Tendonitis 28.51 10.85 64 79917 9076 34867874
Gastrointestinal fistula 28.50 10.85 16 79965 447 34876503
White blood cell count decreased 28.43 10.85 117 79864 95328 34781622
Headache 28.35 10.85 629 79352 200006 34676944
Feeling abnormal 28.27 10.85 244 79737 62991 34813959
Diverticulitis 27.98 10.85 105 79876 19899 34857051
Fibromyalgia 27.97 10.85 35 79946 3065 34873885
Visual impairment 27.74 10.85 158 79823 35644 34841306
Loss of personal independence in daily activities 27.43 10.85 149 79832 33030 34843920
Drug abuse 27.36 10.85 125 79856 98971 34777979
Back disorder 27.12 10.85 52 79929 6599 34870351
Anti-glomerular basement membrane disease 27.10 10.85 8 79973 36 34876914
Dactylitis 27.10 10.85 20 79961 902 34876048
Exposure to communicable disease 27.00 10.85 11 79970 146 34876804
Therapeutic product effect incomplete 26.92 10.85 203 79778 50338 34826612
Drug tolerance 26.74 10.85 33 79948 2849 34874101
Spinal pain 26.46 10.85 48 79933 5841 34871109
Nephrolithiasis 26.29 10.85 138 79843 30195 34846755
Joint stiffness 26.28 10.85 69 79912 10804 34866146
Palpitations 26.24 10.85 169 79812 39817 34837133
Myelosuppression 26.12 10.85 6 79975 19259 34857691
Urticaria 25.98 10.85 237 79744 62140 34814810
Pyrexia 25.87 10.85 573 79408 332440 34544510
Heart rate increased 25.74 10.85 188 79793 46155 34830795
Joint effusion 25.49 10.85 44 79937 5149 34871801
Uveitis 24.90 10.85 54 79927 7481 34869469
Mycobacterium tuberculosis complex test positive 24.54 10.85 22 79959 1310 34875640
Glomerulonephritis membranous 24.52 10.85 21 79960 1176 34875774
Exostosis 24.48 10.85 41 79940 4682 34872268
Respiratory failure 24.35 10.85 147 79834 108425 34768525
Hepatic function abnormal 24.28 10.85 40 79941 44323 34832627
Inflammation 24.02 10.85 128 79853 28167 34848783
Gamma-glutamyltransferase increased 23.98 10.85 19 79962 29212 34847738
Disturbance in attention 23.85 10.85 120 79861 25825 34851125
Blindness 23.80 10.85 82 79899 14904 34862046
Eye swelling 23.72 10.85 63 79918 9932 34867018
Neuroleptic malignant syndrome 23.51 10.85 6 79975 17928 34859022
Ulcer 23.36 10.85 58 79923 8777 34868173
Electrocardiogram QT prolonged 23.28 10.85 36 79945 40916 34836034
Intentional product misuse 23.07 10.85 181 79800 45430 34831520
Gastroduodenal ulcer 22.78 10.85 13 79968 375 34876575
Amnesia 22.43 10.85 120 79861 26443 34850507
Gastrooesophageal reflux disease 22.31 10.85 156 79825 37768 34839182
Acute myeloid leukaemia 22.30 10.85 7 79974 18263 34858687
Metabolic alkalosis 22.30 10.85 22 79959 1479 34875471
Diverticular perforation 22.22 10.85 33 79948 3401 34873549
Acute biphenotypic leukaemia 22.21 10.85 8 79973 74 34876876
Anaemia 22.17 10.85 388 79593 232947 34644003
Foetal exposure during pregnancy 22.14 10.85 33 79948 38068 34838882
Nasopharyngitis 22.02 10.85 251 79730 69717 34807233
Penile swelling 21.80 10.85 17 79964 833 34876117
Neck injury 21.75 10.85 20 79961 1231 34875719
Confusional state 21.64 10.85 218 79763 143942 34733008
Nightmare 21.35 10.85 77 79904 14314 34862636
Energy increased 21.09 10.85 20 79961 1280 34875670
Cardiogenic shock 20.97 10.85 18 79963 26600 34850350
Mucosal inflammation 20.97 10.85 35 79946 38587 34838363
Tendon disorder 20.61 10.85 29 79952 2846 34874104
Hypercholesterolaemia 20.56 10.85 55 79926 8707 34868243
Dry skin 20.38 10.85 132 79849 31155 34845795
Respiratory tract malformation 20.33 10.85 4 79977 0 34876950
Nail bed bleeding 20.28 10.85 12 79969 371 34876579
Epilepsy 20.26 10.85 12 79969 21483 34855467
Breath sounds abnormal 20.15 10.85 47 79934 6834 34870116
Rheumatoid nodule 20.05 10.85 29 79952 2918 34874032
Hiatus hernia 20.01 10.85 50 79931 7595 34869355
Obstructive pancreatitis 19.80 10.85 14 79967 590 34876360
Syndesmophyte 19.72 10.85 8 79973 105 34876845
Musculoskeletal pain 19.70 10.85 133 79848 31830 34845120
Tendon pain 19.69 10.85 29 79952 2966 34873984
Failure of child resistant product closure 19.65 10.85 6 79975 31 34876919
Extrapyramidal disorder 19.62 10.85 3 79978 12877 34864073
Dysstasia 19.60 10.85 67 79914 12128 34864822
Bone marrow failure 19.38 10.85 23 79958 29230 34847720
Steatorrhoea 19.36 10.85 15 79966 728 34876222
Iritis 19.35 10.85 20 79961 1421 34875529
Venous angioma of brain 19.34 10.85 6 79975 33 34876917
Fracture 19.21 10.85 46 79935 6803 34870147
Status epilepticus 19.07 10.85 3 79978 12611 34864339
Seizure 19.05 10.85 151 79830 104706 34772244
Tuberculin test positive 19.02 10.85 18 79963 1149 34875801
Kounis syndrome 18.95 10.85 26 79955 2492 34874458
Chronic pigmented purpura 18.94 10.85 8 79973 117 34876833
Blood pressure systolic increased 18.92 10.85 103 79878 22849 34854101
Hepatitis B core antibody positive 18.77 10.85 11 79970 334 34876616
Bacteraemia 18.60 10.85 11 79970 19706 34857244
Hypervolaemia 18.58 10.85 11 79970 19698 34857252
Tongue disorder 18.49 10.85 39 79942 5300 34871650
Pneumonia aspiration 18.41 10.85 43 79938 41860 34835090
Mobility decreased 18.35 10.85 125 79856 30003 34846947
Aspergillus infection 18.34 10.85 3 79978 12251 34864699
Fixed eruption 18.30 10.85 21 79960 1679 34875271
Gangrene neonatal 18.23 10.85 9 79972 192 34876758
Lymphocyte count decreased 18.19 10.85 15 79966 22607 34854343
Arteriosclerosis coronary artery 17.85 10.85 66 79915 12419 34864531
Acute respiratory failure 17.76 10.85 27 79954 30901 34846049
Polyneuropathy 17.67 10.85 6 79975 14890 34862060
Blood bilirubin unconjugated 17.57 10.85 4 79977 4 34876946
Ventricular fibrillation 17.51 10.85 16 79965 22938 34854012
Drug ineffective 17.39 10.85 1240 78741 455511 34421439
Sensitivity to weather change 17.36 10.85 20 79961 1606 34875344
Rectal haemorrhage 17.30 10.85 154 79827 40095 34836855
Alopecia 17.26 10.85 105 79876 24250 34852700
Bronchopulmonary aspergillosis 17.22 10.85 6 79975 14653 34862297
Rash pruritic 17.14 10.85 113 79868 26828 34850122
Nervous system neoplasm 17.14 10.85 8 79973 150 34876800
Influenza like illness 17.04 10.85 115 79866 27519 34849431
Chest pain 16.81 10.85 394 79587 126368 34750582
Agranulocytosis 16.57 10.85 18 79963 23803 34853147
Gastric ulcer perforation 16.51 10.85 16 79965 1052 34875898
Lipoma 16.40 10.85 20 79961 1706 34875244
Hepatotoxicity 16.36 10.85 15 79966 21470 34855480
Weight decrease neonatal 16.34 10.85 10 79971 329 34876621
Oral pustule 16.34 10.85 9 79972 242 34876708
Clumsiness 16.34 10.85 20 79961 1712 34875238
Renal failure 16.22 10.85 206 79775 130351 34746599
Hypocalcaemia 16.19 10.85 19 79962 24270 34852680
Pulmonary fibrosis 16.15 10.85 84 79897 18312 34858638
Hypoaesthesia 16.12 10.85 213 79768 61231 34815719
Gait disturbance 16.07 10.85 279 79702 84861 34792089
Decreased appetite 16.01 10.85 276 79705 166116 34710834
Tracheal atresia 15.95 10.85 4 79977 8 34876942
Extra dose administered 15.93 10.85 31 79950 3978 34872972
Pruritus 15.50 10.85 430 79551 141551 34735399
Orthostatic hypotension 15.50 10.85 22 79959 25897 34851053
Oesophageal injury 15.35 10.85 5 79976 33 34876917
Undifferentiated connective tissue disease 15.35 10.85 5 79976 33 34876917
Ankle fracture 15.31 10.85 31 79950 4094 34872856
Joint range of motion decreased 15.28 10.85 44 79937 7268 34869682
Skin turgor decreased 15.22 10.85 11 79970 480 34876470
Swollen tongue 15.19 10.85 70 79911 14535 34862415
Laryngospasm 15.06 10.85 18 79963 1503 34875447
Eosinophilic pneumonia 15.05 10.85 28 79953 3473 34873477
Ulcer haemorrhage 14.95 10.85 24 79957 2646 34874304
Encephalopathy 14.92 10.85 37 79944 35282 34841668
Renal arteriosclerosis 14.91 10.85 8 79973 204 34876746
Diverticulum 14.89 10.85 43 79938 7116 34869834
Memory impairment 14.82 10.85 158 79823 43160 34833790
Intervertebral disc degeneration 14.78 10.85 40 79941 6377 34870573
Congenital umbilical hernia 14.74 10.85 9 79972 295 34876655
Acute respiratory distress syndrome 14.60 10.85 23 79958 25946 34851004
Drug intolerance 14.60 10.85 204 79777 59366 34817584
Secondary amyloidosis 14.57 10.85 6 79975 82 34876868
Back injury 14.56 10.85 30 79951 4011 34872939
Moaning 14.51 10.85 13 79968 773 34876177
Dyspepsia 14.50 10.85 138 79843 36594 34840356
Spondyloarthropathy 14.46 10.85 12 79969 643 34876307
Lymphocyte count 14.44 10.85 6 79975 84 34876866
Inflammatory pain 14.40 10.85 8 79973 219 34876731
Inappropriate schedule of product administration 14.34 10.85 211 79770 62085 34814865
Drug ineffective for unapproved indication 14.31 10.85 20 79961 23695 34853255
Blood lactate dehydrogenase increased 14.26 10.85 19 79962 22971 34853979
Incorrect dosage administered 14.24 10.85 16 79965 1250 34875700
Coma 14.22 10.85 55 79926 45623 34831327
Neck mass 14.22 10.85 18 79963 1595 34875355
Peptic ulcer perforation 14.14 10.85 8 79973 227 34876723
Dizziness 14.12 10.85 623 79358 217898 34659052
Arrhythmia 13.99 10.85 39 79942 35769 34841181
Restlessness 13.92 10.85 23 79958 25459 34851491
Peptic ulcer haemorrhage 13.92 10.85 11 79970 550 34876400
Arthroscopy 13.77 10.85 6 79975 95 34876855
Hallucination 13.70 10.85 179 79802 51319 34825631
Pleural effusion 13.64 10.85 120 79861 81426 34795524
Application site haematoma 13.63 10.85 5 79976 49 34876901
Red blood cell sedimentation rate increased 13.57 10.85 49 79932 9113 34867837
Swelling face 13.56 10.85 95 79886 23010 34853940
Dystonia 13.52 10.85 4 79977 10841 34866109
Bone hypertrophy 13.51 10.85 7 79974 166 34876784
Throat tightness 13.50 10.85 46 79935 8312 34868638
Lactic acidosis 13.49 10.85 38 79943 34734 34842216
Micturition urgency 13.38 10.85 39 79942 6486 34870464
Renal impairment 13.32 10.85 145 79836 94368 34782582
Progressive multifocal leukoencephalopathy 13.32 10.85 3 79978 9761 34867189
Deep vein thrombosis 13.26 10.85 91 79890 65157 34811793
Hypotension 13.26 10.85 396 79585 221253 34655697
Depression 13.23 10.85 303 79678 96795 34780155
Tenosynovitis 13.15 10.85 31 79950 4539 34872411
Appendicitis 12.95 10.85 9 79972 14798 34862152
Pulmonary embolism 12.93 10.85 137 79844 89609 34787341
Lymphopenia 12.93 10.85 11 79970 16324 34860626
Myelodysplastic syndrome 12.83 10.85 15 79966 19193 34857757
Product label issue 12.81 10.85 8 79973 273 34876677
Toxic skin eruption 12.80 10.85 5 79976 11380 34865570
Hypoxia 12.66 10.85 74 79907 55021 34821929
Hyperglycaemia 12.64 10.85 47 79934 39433 34837517
Pneumocystis jirovecii pneumonia 12.52 10.85 16 79965 19694 34857256
Rheumatoid lung 12.52 10.85 13 79968 929 34876021
Loss of proprioception 12.49 10.85 9 79972 391 34876559
Hepatic failure 12.48 10.85 39 79942 34492 34842458
Atrioventricular block complete 12.44 10.85 3 79978 9316 34867634
Malignant neoplasm progression 12.44 10.85 135 79846 87911 34789039
Fluid retention 12.29 10.85 27 79954 26860 34850090
Inappropriate antidiuretic hormone secretion 12.19 10.85 7 79974 12746 34864204
Disease recurrence 12.11 10.85 19 79962 21471 34855479
Skin irritation 12.08 10.85 34 79947 5543 34871407
Fibromuscular dysplasia 11.97 10.85 3 79978 6 34876944
Thrombocytosis 11.95 10.85 28 79953 4084 34872866
Tooth disorder 11.95 10.85 53 79928 10829 34866121
Haemangioma 11.95 10.85 18 79963 1879 34875071
Ligament calcification 11.93 10.85 7 79974 213 34876737
Benign prostatic hyperplasia 11.91 10.85 65 79916 14430 34862520
Oral pruritus 11.91 10.85 8 79973 310 34876640
Respiratory arrest 11.90 10.85 107 79874 27936 34849014
Fatigue 11.87 10.85 993 78988 369660 34507290
Lumbar radiculopathy 11.85 10.85 12 79969 832 34876118
Neoplasm progression 11.84 10.85 22 79959 23278 34853672
Malaise 11.83 10.85 529 79452 185296 34691654
Nail injury 11.72 10.85 4 79977 31 34876919
Analgesic drug level increased 11.71 10.85 12 79969 844 34876106
Vanishing bile duct syndrome 11.68 10.85 13 79968 1005 34875945
Red blood cell sedimentation rate 11.67 10.85 14 79967 1174 34875776
Burning sensation 11.61 10.85 77 79904 18317 34858633
COVID-19 pneumonia 11.60 10.85 13 79968 16954 34859996
Proctitis ulcerative 11.60 10.85 5 79976 77 34876873
Steatohepatitis 11.60 10.85 8 79973 324 34876626
Peripheral artery thrombosis 11.59 10.85 20 79961 2340 34874610
Post-traumatic neck syndrome 11.55 10.85 6 79975 143 34876807
Pseudomonas infection 11.55 10.85 7 79974 12375 34864575
Blood creatine phosphokinase increased 11.54 10.85 58 79923 44799 34832151
Tandem gait test abnormal 11.51 10.85 4 79977 33 34876917
Hyperbilirubinaemia 11.41 10.85 13 79968 16830 34860120
Priapism 11.37 10.85 31 79950 4963 34871987
Alcoholic hangover 11.37 10.85 3 79978 8 34876942
Alcohol use 11.37 10.85 24 79957 3264 34873686
Therapeutic response shortened 11.31 10.85 40 79941 7364 34869586
Blood cholesterol increased 11.21 10.85 83 79898 20460 34856490
Swelling 11.16 10.85 147 79834 42219 34834731
Overdose 11.15 10.85 280 79701 90779 34786171
Sopor 11.12 10.85 7 79974 12129 34864821
Salivary hypersecretion 11.12 10.85 3 79978 8641 34868309
Swollen joint count decreased 11.08 10.85 6 79975 156 34876794
Tender joint count decreased 11.08 10.85 6 79975 156 34876794
Pneumonitis 11.06 10.85 40 79941 33838 34843112
Neurotoxicity 11.05 10.85 15 79966 17995 34858955
Failure to thrive 11.04 10.85 3 79978 8598 34868352
Local reaction 10.95 10.85 5 79976 89 34876861
Cognitive disorder 10.93 10.85 107 79874 28586 34848364
Klebsiella infection 10.90 10.85 3 79978 8528 34868422
Joint lock 10.88 10.85 14 79967 1261 34875689
Intentional overdose 10.87 10.85 150 79831 43524 34833426

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Psoriatic arthropathy 513.67 10.08 926 263846 77073 79402543
Ankylosing spondylitis 475.80 10.08 364 264408 11841 79467775
C-reactive protein abnormal 452.42 10.08 673 264099 47694 79431922
Musculoskeletal stiffness 441.14 10.08 1431 263341 173577 79306039
Death 440.11 10.08 754 264018 565760 78913856
Rheumatoid arthritis 436.09 10.08 1602 263170 206868 79272748
Arthralgia 392.64 10.08 3238 261534 568565 78911051
Synovitis 373.91 10.08 1226 263546 149508 79330108
Pain 365.22 10.08 3752 261020 700050 78779566
Joint swelling 352.82 10.08 1889 262883 286757 79192859
Neutropenia 327.63 10.08 284 264488 287426 79192190
Arthropathy 321.90 10.08 1302 263470 175809 79303807
Red blood cell sedimentation rate abnormal 311.27 10.08 366 264406 20597 79459019
Fibromyalgia 311.01 10.08 671 264101 63669 79415947
Febrile neutropenia 302.82 10.08 197 264575 230802 79248814
Drug hypersensitivity 259.96 10.08 1791 262981 297125 79182491
Pancytopenia 254.07 10.08 116 264656 165629 79313987
Migraine 241.88 10.08 739 264033 86754 79392862
Sepsis 239.09 10.08 327 264445 269101 79210515
Thrombocytopenia 227.36 10.08 330 264442 264929 79214687
Drug intolerance 219.29 10.08 1565 263207 262554 79217062
Psoriasis 217.82 10.08 724 264048 88863 79390753
Cardiac failure 212.64 10.08 125 264647 154717 79324899
Arthritis 208.96 10.08 845 263927 114035 79365581
Anaemia 206.66 10.08 770 264002 444245 79035371
Leukopenia 189.00 10.08 75 264697 116438 79363178
Pain in extremity 188.51 10.08 1944 262828 362594 79117022
Pneumonia 186.63 10.08 1355 263417 658891 78820725
Drug interaction 185.88 10.08 729 264043 414454 79065162
Rheumatoid nodule 181.03 10.08 255 264517 17183 79462433
Drug ineffective 179.80 10.08 4774 259998 1076139 78403477
Hyponatraemia 179.74 10.08 195 264577 177653 79301963
Lip swelling 176.70 10.08 408 264364 40503 79439113
Gastric haemorrhage 172.69 10.08 231 264541 14819 79464797
Abdominal pain upper 171.86 10.08 1302 263470 222517 79257099
Cardiospasm 168.66 10.08 116 264656 3185 79476431
Contraindicated product administered 164.46 10.08 989 263783 156549 79323067
Disease progression 163.23 10.08 224 264548 184138 79295478
Pyrexia 161.86 10.08 1458 263314 677251 78802365
Grip strength decreased 159.91 10.08 272 264500 21597 79458019
Gastric ulcer 155.18 10.08 346 264426 33559 79446057
Palmoplantar keratoderma 151.84 10.08 114 264658 3602 79476014
Duodenal ulcer 150.48 10.08 226 264546 16143 79463473
Pruritus genital 147.39 10.08 121 264651 4365 79475251
Mobility decreased 145.85 10.08 795 263977 121380 79358236
Bradycardia 144.45 10.08 142 264630 135415 79344201
Inflammation 140.81 10.08 651 264121 93102 79386514
Drug abuse 139.70 10.08 202 264570 162489 79317127
Polyarthritis 138.04 10.08 186 264586 12016 79467600
Injury 136.10 10.08 564 264208 76932 79402684
Sleep terror 135.59 10.08 115 264657 4343 79475273
Musculoskeletal disorder 135.22 10.08 250 264522 21198 79458418
Joint destruction 133.29 10.08 129 264643 5796 79473820
Dislocation of vertebra 132.92 10.08 147 264625 7733 79471883
Platelet count decreased 132.36 10.08 280 264492 194384 79285232
Human antichimeric antibody positive 129.75 10.08 76 264696 1565 79478051
Peripheral swelling 129.48 10.08 1417 263355 268200 79211416
Drug tolerance 126.35 10.08 150 264622 8525 79471091
Body height below normal 126.31 10.08 81 264691 1972 79477644
C-reactive protein increased 125.81 10.08 796 263976 128231 79351385
Hypoaesthesia 122.08 10.08 1015 263757 178337 79301279
Tension headache 120.74 10.08 134 264638 7077 79472539
Abdominal discomfort 119.12 10.08 1315 263457 249412 79230204
Therapeutic product effect decreased 118.36 10.08 940 263832 162923 79316693
Neck pain 114.96 10.08 526 264246 74891 79404725
Seronegative arthritis 114.78 10.08 107 264665 4585 79475031
Cytomegalovirus infection 113.57 10.08 7 264765 42637 79436979
Atrial fibrillation 110.68 10.08 315 264457 197571 79282045
Musculoskeletal pain 110.25 10.08 648 264124 101706 79377910
Joint laxity 109.57 10.08 78 264694 2266 79477350
Drug tolerance decreased 109.20 10.08 172 264600 12806 79466810
Joint range of motion decreased 109.19 10.08 299 264473 32983 79446633
Immunisation 108.01 10.08 75 264697 2092 79477524
Drug resistance 106.48 10.08 9 264763 42204 79437412
Hypoglycaemia 106.42 10.08 108 264664 101486 79378130
Carotid artery occlusion 106.09 10.08 129 264643 7518 79472098
Hypotension 105.56 10.08 944 263828 439373 79040243
Obesity 104.91 10.08 305 264467 34820 79444796
Respiratory failure 103.38 10.08 285 264487 180626 79298990
Pharyngitis 103.13 10.08 229 264543 22146 79457470
Angioedema 102.61 10.08 512 264260 75523 79404093
Impaired healing 102.32 10.08 567 264205 87088 79392528
Cardiac failure congestive 101.74 10.08 199 264573 142203 79337413
Impaired work ability 100.54 10.08 210 264562 19471 79460145
Malignant neoplasm progression 99.81 10.08 187 264585 135803 79343813
Gastrointestinal pain 99.17 10.08 142 264630 9713 79469903
Disability 98.58 10.08 192 264580 16928 79462688
Foot deformity 98.40 10.08 235 264537 23839 79455777
Atrial tachycardia 96.81 10.08 119 264653 7014 79472602
Off label use 94.91 10.08 2292 262480 904923 78574693
Multiple organ dysfunction syndrome 94.89 10.08 158 264614 120088 79359528
Loose body in joint 94.62 10.08 57 264715 1238 79478378
Upper gastrointestinal haemorrhage 94.01 10.08 327 264445 41053 79438563
Enthesopathy 93.76 10.08 151 264621 11457 79468159
Joint effusion 92.94 10.08 193 264579 17821 79461795
Cytokine release syndrome 92.68 10.08 7 264765 35991 79443625
Anosmia 91.31 10.08 129 264643 8715 79470901
Duodenal ulcer haemorrhage 90.03 10.08 115 264657 7048 79472568
Neutrophil count decreased 89.48 10.08 108 264664 93851 79385765
Renal impairment 89.07 10.08 250 264522 157533 79322083
Renal failure 87.79 10.08 356 264416 200612 79279004
Ascites 86.60 10.08 74 264698 75488 79404128
Femur fracture 86.56 10.08 304 264468 38348 79441268
Orthostatic hypotension 86.50 10.08 39 264733 56125 79423491
Ulcer 86.40 10.08 257 264515 29715 79449901
Pseudoporphyria 86.21 10.08 42 264730 586 79479030
White blood cell count decreased 85.77 10.08 328 264444 187960 79291656
Tenosynovitis 85.41 10.08 171 264601 15383 79464233
Liver injury 83.42 10.08 391 264381 56223 79423393
Foot operation 83.28 10.08 99 264673 5634 79473982
Pain of skin 83.07 10.08 163 264609 14450 79465166
Systemic lupus erythematosus rash 82.61 10.08 60 264712 1800 79477816
Gait inability 81.82 10.08 400 264372 58517 79421099
Facial pain 81.71 10.08 147 264625 12203 79467413
Red blood cell sedimentation rate increased 81.15 10.08 335 264437 45607 79434009
Deafness transitory 81.10 10.08 47 264725 948 79478668
Gastric ulcer haemorrhage 80.66 10.08 123 264649 8904 79470712
Tendonitis 80.08 10.08 216 264556 23614 79456002
Adjustment disorder with depressed mood 80.05 10.08 123 264649 8963 79470653
Hepatic function abnormal 79.70 10.08 75 264697 73032 79406584
Prescribed overdose 78.92 10.08 291 264481 37592 79442024
Wound infection 78.17 10.08 215 264557 23776 79455840
Wheelchair user 77.95 10.08 99 264673 6033 79473583
Urticaria 77.92 10.08 949 263823 184252 79295364
Swelling 77.57 10.08 1078 263694 215633 79263983
Amnesia 77.02 10.08 413 264359 62644 79416972
Bursitis 76.92 10.08 278 264494 35566 79444050
Shoulder arthroplasty 76.75 10.08 73 264699 3209 79476407
Red blood cell sedimentation rate 75.78 10.08 93 264679 5472 79474144
Gamma-glutamyltransferase increased 75.22 10.08 44 264728 54636 79424980
Hypoxia 74.85 10.08 143 264629 103100 79376516
Posterior reversible encephalopathy syndrome 74.16 10.08 3 264769 26278 79453338
Haematemesis 73.41 10.08 356 264416 51908 79427708
Tenosynovitis stenosans 73.00 10.08 69 264703 3009 79476607
Nerve injury 72.91 10.08 120 264652 9272 79470344
Confusional state 72.57 10.08 690 264082 317307 79162309
Myelosuppression 72.10 10.08 22 264750 40274 79439342
Dyspnoea 71.47 10.08 2235 262537 854790 78624826
Bone density decreased 71.22 10.08 145 264627 13202 79466414
Facet joint syndrome 70.32 10.08 131 264641 11171 79468445
Lip dry 70.16 10.08 157 264615 15261 79464355
Hypomagnesaemia 70.04 10.08 34 264738 46877 79432739
Congenital hiatus hernia 70.04 10.08 40 264732 784 79478832
Toothache 68.10 10.08 182 264590 19788 79459828
Joint injury 67.21 10.08 243 264529 31092 79448524
Nephrolithiasis 67.11 10.08 352 264420 52939 79426677
Blood cholesterol increased 66.40 10.08 491 264281 83229 79396387
Respiratory tract congestion 66.18 10.08 180 264592 19774 79459842
Back pain 66.13 10.08 1396 263376 302784 79176832
Memory impairment 65.95 10.08 613 264159 111121 79368495
Fear of injection 64.20 10.08 100 264672 7374 79472242
Osteoporosis 63.78 10.08 351 264421 53761 79425855
Swollen joint count increased 63.64 10.08 194 264578 22733 79456883
Rash 63.56 10.08 2433 262339 575925 78903691
Multiple fractures 62.92 10.08 103 264669 7923 79471693
Encephalopathy 62.56 10.08 79 264693 67318 79412298
Deep vein thrombosis postoperative 62.41 10.08 121 264651 10631 79468985
Synovial fluid analysis 61.99 10.08 56 264716 2303 79477313
Cholecystitis chronic 61.85 10.08 115 264657 9791 79469825
Dizziness 61.78 10.08 2231 262541 524210 78955406
Acute respiratory failure 61.55 10.08 64 264708 59477 79420139
Bone marrow failure 61.10 10.08 48 264724 51059 79428557
Hypervolaemia 60.67 10.08 33 264739 42657 79436959
Constipation 60.04 10.08 625 264147 282425 79197191
Blepharospasm 59.90 10.08 85 264687 5766 79473850
Dehydration 59.41 10.08 532 264240 247655 79231961
Swelling face 58.97 10.08 422 264350 70790 79408826
Hospitalisation 58.76 10.08 142 264630 94094 79385522
Rheumatic fever 58.48 10.08 218 264554 28307 79451309
Agranulocytosis 58.13 10.08 39 264733 44991 79434625
Eye pruritus 57.98 10.08 175 264597 20395 79459221
Limb discomfort 57.59 10.08 239 264533 32611 79447005
Pleuritic pain 57.41 10.08 113 264659 10039 79469577
Cardiogenic shock 57.27 10.08 34 264738 41880 79437736
Neuroleptic malignant syndrome 57.21 10.08 11 264761 27548 79452068
Mucosal inflammation 57.16 10.08 102 264670 75478 79404138
Hyperglycaemia 56.81 10.08 91 264681 70244 79409372
Osteoarthritis 56.65 10.08 489 264283 86820 79392796
IgM nephropathy 55.98 10.08 20 264752 118 79479498
Sopor 55.59 10.08 20 264752 32990 79446626
Drug specific antibody 54.99 10.08 55 264717 2573 79477043
Thrombotic microangiopathy 54.66 10.08 3 264769 20166 79459450
Nodule 54.23 10.08 184 264588 22810 79456806
Hypokalaemia 53.40 10.08 271 264501 143769 79335847
Acute myeloid leukaemia 53.24 10.08 18 264754 30867 79448749
Seizure 52.88 10.08 388 264384 188446 79291170
Dactylitis 52.78 10.08 55 264717 2702 79476914
Bone disorder 52.37 10.08 161 264611 18952 79460664
Mycotic allergy 52.07 10.08 42 264730 1477 79478139
Neoplasm progression 51.80 10.08 57 264715 51625 79427991
Scleritis 51.73 10.08 68 264704 4288 79475328
Aspergillus infection 51.46 10.08 3 264769 19158 79460458
Dyspepsia 51.05 10.08 569 264203 108118 79371498
Cardiac arrest 50.93 10.08 348 264424 171748 79307868
Pulmonary hypertension 50.47 10.08 51 264721 48029 79431587
Gastrooesophageal reflux disease 50.46 10.08 549 264223 103697 79375919
Blood creatine phosphokinase increased 50.15 10.08 89 264683 66001 79413615
Cerebral haemorrhage 50.07 10.08 71 264701 57602 79422014
Loss of personal independence in daily activities 50.01 10.08 541 264231 102039 79377577
Sacroiliitis 49.93 10.08 62 264710 3692 79475924
Pulmonary arterial hypertension 49.83 10.08 16 264756 28350 79451266
Synovial cyst 49.79 10.08 106 264666 9959 79469657
Electrocardiogram QT prolonged 49.68 10.08 145 264627 90241 79389375
Syncope 49.63 10.08 370 264402 179079 79300537
Wrist deformity 49.34 10.08 47 264725 2070 79477546
Musculoskeletal discomfort 48.80 10.08 161 264611 19674 79459942
Osteonecrosis of jaw 48.71 10.08 43 264729 43183 79436433
Respiratory distress 48.52 10.08 74 264698 58265 79421351
Peripheral venous disease 48.33 10.08 139 264633 15770 79463846
Ventricular fibrillation 47.87 10.08 23 264749 31903 79447713
Melaena 47.65 10.08 356 264416 60534 79419082
Blood parathyroid hormone decreased 47.62 10.08 107 264665 10429 79469187
Type 2 diabetes mellitus 47.58 10.08 339 264433 56783 79422833
Bunion operation 47.57 10.08 33 264739 919 79478697
Clostridium difficile colitis 47.28 10.08 24 264748 32259 79447357
Dysstasia 47.18 10.08 200 264572 27546 79452070
Acute respiratory distress syndrome 47.11 10.08 46 264726 44021 79435595
Hip arthroplasty 46.98 10.08 239 264533 35517 79444099
Myelodysplastic syndrome 46.72 10.08 21 264751 30280 79449336
Septic shock 46.69 10.08 229 264543 122572 79357044
Faeces discoloured 46.50 10.08 206 264566 28921 79450695
Malaise 46.45 10.08 2029 262743 487840 78991776
Tongue disorder 46.28 10.08 126 264646 13849 79465767
Neuropathy peripheral 46.28 10.08 277 264495 141028 79338588
Emotional distress 46.26 10.08 258 264514 39711 79439905
Bronchopulmonary aspergillosis 46.07 10.08 9 264763 22285 79457331
Neovascularisation 46.05 10.08 36 264736 1209 79478407
Nasopharyngitis 46.05 10.08 1136 263636 252745 79226871
Knee arthroplasty 46.02 10.08 273 264499 42975 79436641
Tinnitus 46.00 10.08 278 264494 44055 79435561
International normalised ratio increased 45.77 10.08 137 264635 84584 79395032
Feeling abnormal 45.75 10.08 763 264009 158436 79321180
Bacteraemia 45.74 10.08 26 264746 32798 79446818
Autoimmune disorder 45.58 10.08 140 264632 16472 79463144
Therapy non-responder 44.62 10.08 486 264286 91819 79387797
Cartilage atrophy 44.48 10.08 18 264754 156 79479460
Muscle twitching 44.06 10.08 181 264591 24583 79455033
Rheumatoid lung 43.94 10.08 62 264710 4183 79475433
Tooth disorder 43.76 10.08 188 264584 26045 79453571
Electrolyte imbalance 43.69 10.08 24 264748 30857 79448759
Neurotoxicity 43.56 10.08 27 264745 32491 79447125
Hand deformity 43.45 10.08 532 264240 103387 79376229
Rash pruritic 43.27 10.08 395 264377 71234 79408382
Arrhythmia 42.56 10.08 87 264685 61185 79418431
Granuloma skin 42.39 10.08 94 264678 9080 79470536
Tenderness 42.22 10.08 173 264599 23469 79456147
Adrenal insufficiency 42.15 10.08 197 264575 28290 79451326
Hepatotoxicity 41.88 10.08 66 264706 51286 79428330
Antibody test positive 41.86 10.08 49 264723 2743 79476873
Right ventricular failure 41.73 10.08 13 264759 23484 79456132
Accidental exposure to product by child 41.64 10.08 50 264722 2876 79476740
Night sweats 41.57 10.08 306 264466 51789 79427827
Anxiety 41.55 10.08 1100 263672 247412 79232204
Duodenal ulcer perforation 41.47 10.08 368 264404 65843 79413773
Psychotic disorder 41.12 10.08 46 264726 41356 79438260
Osteoporotic fracture 41.07 10.08 60 264712 4180 79475436
Transient ischaemic attack 40.62 10.08 307 264465 52388 79427228
Hunger 40.32 10.08 68 264704 5360 79474256
Oedema peripheral 40.29 10.08 592 264180 251696 79227920
Fracture delayed union 40.23 10.08 42 264730 2068 79477548
Infection 40.15 10.08 1069 263703 240643 79238973
Hallucination, visual 40.07 10.08 30 264742 32699 79446917
Polyneuropathy 40.05 10.08 15 264757 24136 79455480
Juvenile idiopathic arthritis 39.90 10.08 63 264709 4700 79474916
Alopecia 39.82 10.08 1028 263744 230327 79249289
Walking aid user 39.27 10.08 97 264675 10051 79469565
Dry mouth 39.17 10.08 456 264316 87563 79392053
Gastrointestinal haemorrhage 38.85 10.08 698 264074 147021 79332595
Hepatic cytolysis 38.56 10.08 21 264751 27130 79452486
Product use in unapproved indication 38.42 10.08 592 264180 249767 79229849
Acute kidney injury 38.33 10.08 1375 263397 518029 78961587
Intestinal obstruction 38.31 10.08 52 264720 42968 79436648
Premature delivery 38.21 10.08 15 264757 23452 79456164
Cerebral infarction 37.93 10.08 58 264714 45618 79433998
Colitis 37.86 10.08 121 264651 73186 79406430
Lactic acidosis 37.85 10.08 114 264658 70245 79409371
Tooth infection 37.84 10.08 143 264629 18689 79460927
Ankle arthroplasty 37.73 10.08 35 264737 1490 79478126
Blood creatinine increased 37.69 10.08 331 264441 154726 79324890
Fall 37.56 10.08 1284 263488 486345 78993271
Panniculitis 37.49 10.08 108 264664 12263 79467353
Smear cervix abnormal 37.18 10.08 44 264728 2492 79477124
Therapeutic response decreased 37.06 10.08 362 264410 66491 79413125
Subdural haematoma 36.98 10.08 30 264742 31404 79448212
Urosepsis 36.90 10.08 21 264751 26474 79453142
Pulmonary fibrosis 36.86 10.08 262 264510 43850 79435766
Paraesthesia 36.59 10.08 804 263968 175519 79304097
Iritis 36.54 10.08 54 264718 3801 79475815
Functional gastrointestinal disorder 36.39 10.08 62 264710 4928 79474688
Pneumonia aspiration 36.38 10.08 108 264664 66859 79412757
Pathogen resistance 36.33 10.08 3 264769 14339 79465277
Gait disturbance 36.28 10.08 924 263848 206582 79273034
Hyperkalaemia 36.02 10.08 227 264545 114171 79365445
Pleural effusion 35.79 10.08 309 264463 144953 79334663
Arthrodesis 35.68 10.08 42 264730 2365 79477251
Sciatica 35.53 10.08 210 264562 33012 79446604
Eosinophilia 35.37 10.08 60 264712 45285 79434331
Sedation complication 35.32 10.08 5 264767 15664 79463952
Blood pressure decreased 35.25 10.08 190 264582 99276 79380340
Oesophageal spasm 35.07 10.08 50 264722 3406 79476210
Status epilepticus 34.65 10.08 20 264752 25021 79454595
Pseudomonas infection 34.64 10.08 13 264759 20890 79458726
Schizophrenia 34.63 10.08 5 264767 15435 79464181
COVID-19 pneumonia 34.61 10.08 27 264745 28822 79450794
Depressed level of consciousness 34.60 10.08 184 264588 96468 79383148
Plasma cell myeloma 34.20 10.08 79 264693 53180 79426436
Device related infection 34.17 10.08 38 264734 34256 79445360
Diabetes mellitus inadequate control 34.12 10.08 19 264753 24245 79455371
Circulatory collapse 34.08 10.08 45 264727 37623 79441993
Milk-alkali syndrome 34.00 10.08 32 264740 1388 79478228
Limb deformity 33.61 10.08 50 264722 3540 79476076
Ileus 33.43 10.08 23 264749 26188 79453428
Photophobia 33.39 10.08 146 264626 20382 79459234
Sensitivity to weather change 33.37 10.08 79 264693 7968 79471648
Allergy to chemicals 33.06 10.08 42 264730 2560 79477056
Blood bilirubin increased 33.04 10.08 111 264661 66121 79413495
Breast cancer stage III 32.95 10.08 89 264683 9737 79469879
Creatinine renal clearance decreased 32.88 10.08 11 264761 18991 79460625
Palmar-plantar erythrodysaesthesia syndrome 32.71 10.08 37 264735 33097 79446519
Tendon disorder 32.50 10.08 73 264699 7113 79472503
Intestinal diaphragm disease 32.49 10.08 18 264754 332 79479284
Pneumocystis jirovecii pneumonia 32.42 10.08 36 264736 32472 79447144
Gastrointestinal ulcer 32.27 10.08 48 264724 3398 79476218
Blood lactate dehydrogenase increased 32.27 10.08 50 264722 39120 79440496
Wrong technique in product usage process 32.14 10.08 131 264641 73744 79405872
Lymphocyte count decreased 32.12 10.08 68 264704 47221 79432395
Diplopia 31.68 10.08 205 264567 33261 79446355
Cytopenia 31.62 10.08 14 264758 20369 79459247
Haematoma 31.48 10.08 80 264692 52115 79427501
Pericarditis 31.20 10.08 503 264269 103733 79375883
Withdrawal arrhythmia 31.15 10.08 10 264762 40 79479576
Aspartate aminotransferase increased 31.08 10.08 302 264470 138339 79341277
Hepatocellular injury 31.04 10.08 70 264702 47523 79432093
Enterococcal infection 30.96 10.08 7 264765 15653 79463963
Blood alkaline phosphatase increased 30.88 10.08 108 264664 63556 79416060
Lower respiratory tract infection 30.66 10.08 601 264171 128619 79350997
Restlessness 30.63 10.08 68 264704 46424 79433192
Ischaemic stroke 30.57 10.08 39 264733 33092 79446524
Tumour lysis syndrome 30.54 10.08 21 264751 23918 79455698
Feeling jittery 30.49 10.08 103 264669 12738 79466878
Drug level increased 30.44 10.08 53 264719 39598 79440018
Alanine aminotransferase abnormal 30.42 10.08 81 264691 8786 79470830
Cardio-respiratory arrest 30.34 10.08 223 264549 108287 79371329
Lymphopenia 30.29 10.08 34 264738 30523 79449093
Peptic ulcer 30.16 10.08 65 264707 6158 79473458
Full blood count decreased 29.83 10.08 27 264745 26792 79452824
Cholestasis 29.81 10.08 82 264690 52027 79427589
Metastases to liver 29.75 10.08 30 264742 28284 79451332
Labelled drug-drug interaction medication error 29.39 10.08 29 264743 27621 79451995
Disability assessment scale score increased 29.33 10.08 46 264726 3412 79476204
Uveitis 29.15 10.08 122 264650 16708 79462908
Cytomegalovirus viraemia 29.11 10.08 4 264768 12817 79466799
Adverse drug reaction 29.11 10.08 343 264429 66049 79413567
Left ventricular dysfunction 28.95 10.08 14 264758 19347 79460269
C-reactive protein 28.86 10.08 56 264716 4923 79474693
Rhabdomyolysis 28.81 10.08 212 264560 102919 79376697
Gastritis 28.65 10.08 264 264508 47729 79431887
Hepatic encephalopathy 28.51 10.08 23 264749 24143 79455473
Blood pressure systolic increased 28.46 10.08 344 264428 66642 79412974
Rash papular 28.44 10.08 146 264626 21770 79457846
Discomfort 28.39 10.08 580 264192 125037 79354579
Venoocclusive liver disease 28.38 10.08 3 264769 11768 79467848
Pulmonary oedema 28.36 10.08 174 264598 88080 79391536
Pancreatitis 28.35 10.08 124 264648 68451 79411165
Hepatic failure 28.26 10.08 106 264666 61106 79418510
Gastric disorder 28.24 10.08 217 264555 37216 79442400
Atrioventricular block complete 28.08 10.08 10 264762 16600 79463016
Crepitations 28.02 10.08 85 264687 9932 79469684
Soft tissue injury 27.95 10.08 32 264740 1749 79477867
Gastroenteritis viral 27.88 10.08 159 264613 24672 79454944
Cardiac failure acute 27.83 10.08 14 264758 18915 79460701
Fatigue 27.57 10.08 3506 261266 926221 78553395
Fixed eruption 27.46 10.08 41 264731 2913 79476703
Epstein-Barr virus infection 27.41 10.08 7 264765 14409 79465207
Intentional product use issue 27.36 10.08 680 264092 151432 79328184
Treatment failure 27.16 10.08 750 264022 169736 79309880
Oesophageal pain 27.12 10.08 50 264722 4229 79475387
Serum sickness-like reaction 27.11 10.08 20 264752 615 79479001
Short stature 27.10 10.08 21 264751 696 79478920
Malnutrition 27.07 10.08 21 264751 22481 79457135
Spinal fusion surgery 26.88 10.08 56 264716 5182 79474434
Cerebrovascular accident 26.69 10.08 359 264413 154933 79324683
Completed suicide 26.44 10.08 1032 263740 244735 79234881
Haemorrhage intracranial 26.13 10.08 29 264743 26164 79453452
Chronic kidney disease 25.93 10.08 122 264650 66032 79413584
Spondyloarthropathy 25.89 10.08 24 264748 1021 79478595
Transaminases increased 25.62 10.08 87 264685 51656 79427960
Pericardial effusion 25.53 10.08 74 264698 46163 79433453
Unresponsive to stimuli 25.50 10.08 97 264675 55691 79423925
Deformity 25.47 10.08 80 264692 9525 79470091
Oedema 25.35 10.08 547 264225 119033 79360583
Pneumonitis 25.19 10.08 110 264662 60750 79418866
Vasculitis 25.15 10.08 156 264616 24946 79454670
Prostate cancer 25.06 10.08 45 264727 33223 79446393
Antinuclear antibody positive 25 10.08 70 264702 7820 79471796
Hypophosphataemia 24.70 10.08 18 264754 19895 79459721
Device ineffective 24.66 10.08 12 264760 167 79479449
Pemphigoid 24.59 10.08 10 264762 15305 79464311
Gallbladder injury 24.53 10.08 25 264747 1196 79478420
Bone density increased 24.43 10.08 21 264751 808 79478808
Alanine aminotransferase increased 24.39 10.08 386 264386 162184 79317432
Finger deformity 24.37 10.08 67 264705 7407 79472209
Skin ulcer 24.29 10.08 281 264491 53869 79425747
Quality of life decreased 24.23 10.08 83 264689 10337 79469279
Exposure during pregnancy 24.08 10.08 217 264555 100915 79378701
Body temperature decreased 24.06 10.08 186 264586 31959 79447657
Pharyngeal swelling 23.99 10.08 68 264704 7651 79471965
Disseminated intravascular coagulation 23.96 10.08 52 264720 35790 79443826
Coma 23.94 10.08 216 264556 100433 79379183
Kidney infection 23.94 10.08 139 264633 21712 79457904
Muscular weakness 23.91 10.08 701 264071 160028 79319588
Skin necrosis 23.83 10.08 121 264651 17966 79461650
Shock 23.82 10.08 70 264702 43478 79436138
Aplastic anaemia 23.80 10.08 15 264757 17890 79461726
Drug level decreased 23.79 10.08 9 264763 14393 79465223
Synovial disorder 23.62 10.08 31 264741 1952 79477664
Spinal osteoarthritis 23.55 10.08 115 264657 16812 79462804
Failure of child resistant product closure 23.54 10.08 9 264763 66 79479550
Hyperbilirubinaemia 23.53 10.08 28 264744 24490 79455126
General physical health deterioration 23.48 10.08 715 264057 274523 79205093
Blindness 23.38 10.08 168 264604 28215 79451401
Device expulsion 23.29 10.08 31 264741 25830 79453786
Blood sodium decreased 23.28 10.08 47 264725 33208 79446408
Dystonia 23.26 10.08 22 264750 21377 79458239
Cardiotoxicity 23.16 10.08 6 264766 12233 79467383
Gastritis erosive 23.16 10.08 84 264688 10763 79468853
Troponin increased 23.12 10.08 18 264754 19237 79460379
Myoclonus 23.08 10.08 35 264737 27625 79451991
Clostridium difficile infection 23.07 10.08 69 264703 42616 79437000
Feeding disorder 23.02 10.08 111 264661 16143 79463473
Toxic skin eruption 22.99 10.08 24 264748 22269 79457347
Wheezing 22.94 10.08 528 264244 116136 79363480
Dementia 22.78 10.08 29 264743 24630 79454986
Headache 22.74 10.08 2491 262281 651281 78828335
Dry skin 22.60 10.08 334 264438 67661 79411955
Vaginal infection 22.54 10.08 56 264716 5824 79473792
Skin papilloma 22.50 10.08 56 264716 5830 79473786
Nail psoriasis 22.46 10.08 18 264754 627 79478989
Inappropriate antidiuretic hormone secretion 22.24 10.08 33 264739 26280 79453336
Prescribed underdose 22.21 10.08 171 264601 29343 79450273
Endometriosis 22.18 10.08 42 264730 3626 79475990
Product dose omission issue 22.12 10.08 639 264133 246898 79232718
Epistaxis 22.10 10.08 250 264522 111265 79368351
Failure to thrive 22.05 10.08 6 264766 11838 79467778
Parkinsonism 21.89 10.08 14 264758 16570 79463046
Ear infection 21.88 10.08 192 264580 34240 79445376
Blood potassium decreased 21.82 10.08 80 264692 46432 79433184
Tendon pain 21.81 10.08 54 264718 5604 79474012
Aggression 21.77 10.08 91 264681 50867 79428749
Collagen-vascular disease 21.66 10.08 9 264763 84 79479532
Immunodeficiency 21.63 10.08 135 264637 21633 79457983
Depression 21.62 10.08 903 263869 215887 79263729
Gastroduodenal ulcer 21.52 10.08 16 264756 498 79479118
Heart rate increased 21.50 10.08 539 264233 120185 79359431
Progressive multifocal leukoencephalopathy 21.45 10.08 22 264750 20578 79459038
Anti-glomerular basement membrane disease 21.36 10.08 8 264764 55 79479561
Sudden death 21.29 10.08 26 264746 22485 79457131
Joint stiffness 21.14 10.08 218 264554 40612 79439004
Kounis syndrome 21.07 10.08 45 264727 4237 79475379
Glossodynia 21.04 10.08 470 264302 102867 79376749
Blood pressure measurement 21.00 10.08 15 264757 438 79479178
Hypothyroidism 20.90 10.08 96 264676 52296 79427320
Chronic obstructive pulmonary disease 20.90 10.08 182 264590 85237 79394379
Adenoiditis 20.89 10.08 7 264765 33 79479583
Oxygen saturation decreased 20.86 10.08 302 264470 128745 79350871
Subarachnoid haemorrhage 20.84 10.08 146 264626 24319 79455297
Medication overuse headache 20.79 10.08 20 264752 892 79478724
Appendicitis 20.76 10.08 23 264749 20771 79458845
Hyperthyroidism 20.64 10.08 26 264746 22183 79457433
Lower limb fracture 20.64 10.08 140 264632 23075 79456541
Bradyphrenia 20.55 10.08 5 264767 10635 79468981
Insomnia 20.48 10.08 1003 263769 244167 79235449
Extra dose administered 20.43 10.08 68 264704 8347 79471269
Bronchospasm 20.22 10.08 32 264740 24827 79454789
Onychomadesis 20.17 10.08 50 264722 5192 79474424
Urinary tract infection 20.13 10.08 727 264045 273785 79205831
Rales 20.11 10.08 22 264750 19979 79459637
Dysphagia 20.03 10.08 285 264487 121851 79357765
Cachexia 19.92 10.08 6 264766 11077 79468539
X-ray abnormal 19.84 10.08 53 264719 5760 79473856
Muscle spasms 19.80 10.08 738 264034 173992 79305624
Skin fissures 19.77 10.08 91 264681 12982 79466634
Hepatic enzyme abnormal 19.75 10.08 64 264708 7746 79471870
Product used for unknown indication 19.74 10.08 25 264747 1519 79478097
Visual impairment 19.70 10.08 422 264350 91709 79387907
Human anti-human antibody test 19.60 10.08 14 264758 409 79479207
Cholangitis 19.47 10.08 9 264763 12767 79466849
Renal papillary necrosis 19.39 10.08 14 264758 416 79479200
Product use issue 19.36 10.08 867 263905 208955 79270661
Hypernatraemia 19.35 10.08 12 264760 14439 79465177
Jejunal ulcer 19.33 10.08 11 264761 214 79479402
Diabetic ketoacidosis 19.29 10.08 54 264718 34068 79445548
Haemoptysis 19.27 10.08 108 264664 55891 79423725
Bone lesion 19.24 10.08 53 264719 5866 79473750
Immune reconstitution inflammatory syndrome 19.23 10.08 11 264761 13830 79465786
Trigger finger 19.06 10.08 43 264729 4202 79475414
Tachycardia 19.03 10.08 447 264325 177321 79302295
Anaphylactic reaction 19.02 10.08 387 264385 83356 79396260
Blood calcium decreased 19.01 10.08 49 264723 31770 79447846
Hypersensitivity 18.91 10.08 1058 263714 261181 79218435
Radiation associated pain 18.90 10.08 9 264763 119 79479497
Altered state of consciousness 18.88 10.08 78 264694 43744 79435872
Glomerulonephritis membranous 18.84 10.08 25 264747 1591 79478025
Clear cell renal cell carcinoma 18.78 10.08 32 264740 2544 79477072
Therapeutic response shortened 18.76 10.08 103 264669 15760 79463856
Jaundice cholestatic 18.73 10.08 7 264765 11277 79468339
Product label confusion 18.72 10.08 25 264747 1601 79478015
Joint noise 18.68 10.08 41 264731 3933 79475683
Renal mass 18.67 10.08 37 264735 3303 79476313
Myofascial pain syndrome 18.54 10.08 28 264744 2009 79477607
Urinary retention 18.54 10.08 111 264661 56519 79423097
Pneumonia fungal 18.53 10.08 7 264765 11203 79468413
Haematuria 18.51 10.08 143 264629 68693 79410923
Hepatic cirrhosis 18.45 10.08 57 264715 34849 79444767
Anti-transglutaminase antibody 18.44 10.08 5 264767 9 79479607
Blood pressure systolic abnormal 18.43 10.08 109 264663 17138 79462478
Mucormycosis 18.41 10.08 3 264769 8466 79471150
Head injury 18.38 10.08 63 264709 37306 79442310
Amblyopia 18.34 10.08 11 264761 237 79479379
Atrioventricular block 18.34 10.08 12 264760 14029 79465587
Cystitis haemorrhagic 18.34 10.08 4 264768 9168 79470448
Neutropenic sepsis 18.31 10.08 39 264733 27025 79452591
Muscle swelling 18.26 10.08 18 264754 827 79478789
Hyperammonaemia 18.21 10.08 7 264765 11086 79468530
Anti-cyclic citrullinated peptide antibody positive 18.16 10.08 382 264390 82761 79396855
Mental status changes 18.05 10.08 139 264633 66820 79412796
Back injury 18.00 10.08 76 264696 10447 79469169
Bladder cancer 18 10.08 23 264749 19503 79460113
Drug reaction with eosinophilia and systemic symptoms 17.97 10.08 132 264640 64112 79415504
Post-traumatic neck syndrome 17.96 10.08 28 264744 2066 79477550
Tachypnoea 17.93 10.08 51 264721 32012 79447604
Balance disorder 17.91 10.08 226 264546 98631 79380985
Hepatocellular carcinoma 17.90 10.08 4 264768 9017 79470599
Metastases to fallopian tube 17.89 10.08 7 264765 55 79479561
Sternal fracture 17.88 10.08 31 264741 2499 79477117
Flank pain 17.84 10.08 120 264652 19724 79459892
Lipase increased 17.82 10.08 17 264755 16449 79463167
Biliary dyskinesia 17.75 10.08 31 264741 2514 79477102
Myocarditis 17.66 10.08 28 264744 21705 79457911
Chronic spontaneous urticaria 17.55 10.08 21 264751 1203 79478413
Metastases to bone 17.55 10.08 34 264738 24393 79455223
Sleep disorder 17.54 10.08 390 264382 85287 79394329
Hepatic adenoma 17.49 10.08 12 264760 328 79479288
Glomerulonephritis minimal lesion 17.45 10.08 17 264755 770 79478846
Sinus bradycardia 17.40 10.08 36 264736 25211 79454405
Ventricular arrhythmia 17.38 10.08 4 264768 8836 79470780
Malignant melanoma in situ 17.27 10.08 30 264742 2422 79477194
Aphasia 17.26 10.08 88 264684 46644 79432972
Nail dystrophy 17.26 10.08 19 264753 994 79478622
Limb asymmetry 17.25 10.08 15 264757 586 79479030
Myopathy 17.18 10.08 26 264746 20537 79459079
Abnormal loss of weight 17.16 10.08 64 264708 8312 79471304
Red cell distribution width decreased 17.13 10.08 27 264745 2011 79477605
Lip oedema 17.11 10.08 53 264719 6263 79473353
Decreased appetite 17.08 10.08 946 263826 341472 79138144
Adverse event 17.06 10.08 288 264484 59926 79419690
Fluid retention 16.96 10.08 149 264623 69660 79409956
Swollen tongue 16.96 10.08 216 264556 42354 79437262
Blood pressure diastolic increased 16.91 10.08 94 264678 14448 79465168
Respiratory acidosis 16.90 10.08 8 264764 11192 79468424
Inflammatory pain 16.84 10.08 19 264753 1022 79478594
Tardive dyskinesia 16.81 10.08 7 264765 10564 79469052
Heart rate 16.79 10.08 8 264764 106 79479510
No adverse event 16.78 10.08 65 264707 37127 79442489
Dialysis 16.76 10.08 22 264750 18440 79461176
COVID-19 16.72 10.08 397 264375 157277 79322339
Hypertensive crisis 16.65 10.08 27 264745 20743 79458873
Blood pressure diastolic abnormal 16.60 10.08 115 264657 19087 79460529
Renal cancer 16.59 10.08 10 264762 12216 79467400
Ejection fraction decreased 16.54 10.08 59 264713 34518 79445098
Musculoskeletal deformity 16.51 10.08 23 264749 1533 79478083
Hallucination, auditory 16.49 10.08 27 264745 20666 79458950
Candida infection 16.47 10.08 68 264704 38146 79441470
Endocarditis fibroplastica 16.43 10.08 5 264767 16 79479600
Haemolytic anaemia 16.42 10.08 21 264751 17799 79461817
Disease recurrence 16.33 10.08 83 264689 44026 79435590
Urinary incontinence 16.29 10.08 75 264697 40834 79438782
Intentional overdose 16.26 10.08 464 264308 105496 79374120
Periorbital oedema 16.22 10.08 63 264709 8339 79471277
Coagulopathy 16.20 10.08 63 264709 35943 79443673
Staphylococcal infection 16.20 10.08 120 264652 58175 79421441
Rheumatoid factor positive 16.16 10.08 284 264488 59555 79420061
Aspirin-exacerbated respiratory disease 16.16 10.08 20 264752 1187 79478429
Blood bilirubin unconjugated 16.09 10.08 4 264768 4 79479612
Heparin-induced thrombocytopenia 16.08 10.08 6 264766 9676 79469940
Pulseless electrical activity 16.06 10.08 14 264758 14146 79465470
Generalised tonic-clonic seizure 16.04 10.08 83 264689 43827 79435789
Vascular device infection 16.03 10.08 7 264765 10269 79469347
Device leakage 16.00 10.08 8 264764 10848 79468768
Therapy interrupted 15.99 10.08 52 264720 31289 79448327
Transfusion 15.93 10.08 29 264743 21301 79458315
Cardiomyopathy 15.92 10.08 46 264726 28728 79450888
Gastrointestinal fistula 15.92 10.08 16 264756 753 79478863
Road traffic accident 15.91 10.08 218 264554 43446 79436170
Left ventricular failure 15.80 10.08 6 264766 9575 79470041
Helicobacter infection 15.79 10.08 322 264450 69382 79410234
Gastrointestinal disorder 15.79 10.08 524 264248 121681 79357935
Hypercapnia 15.77 10.08 5 264767 8930 79470686
Peripheral arterial occlusive disease 15.72 10.08 4 264768 8254 79471362
Product monitoring error 15.69 10.08 5 264767 8901 79470715
Enterocolitis 15.68 10.08 15 264757 14497 79465119
Incorrect dosage administered 15.64 10.08 31 264741 2768 79476848
IIIrd nerve injury 15.62 10.08 4 264768 5 79479611
Pneumonia bacterial 15.62 10.08 25 264747 19306 79460310
Bacterial sepsis 15.55 10.08 4 264768 8194 79471422
Acute coronary syndrome 15.55 10.08 29 264743 21104 79458512
Hyperuricaemia 15.52 10.08 10 264762 11789 79467827
Brain herniation 15.45 10.08 3 264769 7460 79472156
Stress cardiomyopathy 15.33 10.08 9 264763 11157 79468459
Second primary malignancy 15.31 10.08 15 264757 14335 79465281
Nightmare 15.30 10.08 142 264630 25719 79453897
Staphylococcal bacteraemia 15.21 10.08 11 264761 12207 79467409
Toxicity to various agents 15.20 10.08 1199 263573 420341 79059275
Anal incontinence 15.15 10.08 23 264749 18145 79461471
Metastases to lung 15.14 10.08 23 264749 18140 79461476
Eye pain 15.11 10.08 191 264581 37387 79442229
Eye irritation 15.11 10.08 119 264653 20562 79459054
Hypoalbuminaemia 14.99 10.08 30 264742 21267 79458349
Adverse reaction 14.96 10.08 66 264706 9248 79470368
Eosinophil count increased 14.90 10.08 21 264751 17084 79462532
Gastric ulcer perforation 14.88 10.08 26 264746 2109 79477507
Rash maculo-papular 14.84 10.08 117 264655 55961 79423655
Cushingoid 14.83 10.08 67 264705 9485 79470131
Vaginal stricture 14.82 10.08 4 264768 7 79479609
Somnolence 14.69 10.08 646 264126 238335 79241281
Hostility 14.65 10.08 27 264745 2283 79477333
Glaucoma 14.64 10.08 27 264745 19734 79459882
Palpitations 14.64 10.08 536 264236 126074 79353542
Chronic sinusitis 14.63 10.08 13 264759 13013 79466603
Peptic ulcer perforation 14.43 10.08 12 264760 441 79479175
Hyperhidrosis 14.42 10.08 628 264144 150864 79328752
Mania 14.39 10.08 24 264748 18236 79461380
Disorientation 14.38 10.08 136 264636 62640 79416976
Device occlusion 14.37 10.08 11 264761 11855 79467761
Normal newborn 14.31 10.08 3 264769 7069 79472547
Infective pulmonary exacerbation of cystic fibrosis 14.22 10.08 13 264759 12838 79466778
Neutrophil count increased 14.16 10.08 50 264722 29346 79450270
Haemolysis 14.13 10.08 13 264759 12799 79466817
Penile swelling 14.05 10.08 14 264758 652 79478964
Asphyxia 14.02 10.08 11 264761 11709 79467907
Intestinal ischaemia 14.01 10.08 14 264758 13256 79466360
Klebsiella infection 14.00 10.08 19 264753 15701 79463915
Tachyarrhythmia 13.99 10.08 3 264769 6959 79472657
Akathisia 13.99 10.08 14 264758 13245 79466371
Brain natriuretic peptide increased 13.99 10.08 6 264766 8894 79470722
End stage renal disease 13.96 10.08 12 264760 12208 79467408
Acute biphenotypic leukaemia 13.95 10.08 8 264764 158 79479458
Endocarditis 13.92 10.08 9 264763 10588 79469028
Escherichia infection 13.90 10.08 24 264748 17993 79461623
Hiccups 13.90 10.08 8 264764 10023 79469593
Diverticulitis 13.86 10.08 222 264550 45714 79433902
Hypomania 13.71 10.08 4 264768 7540 79472076
Nail bed bleeding 13.70 10.08 14 264758 672 79478944
Ventricular extrasystoles 13.66 10.08 28 264744 19676 79459940
Colitis ulcerative 13.65 10.08 64 264708 34678 79444938
Faecaloma 13.65 10.08 11 264761 11553 79468063
Fine motor skill dysfunction 13.64 10.08 44 264728 5313 79474303
Systemic lupus erythematosus 13.55 10.08 511 264261 120638 79358978
Brain oedema 13.54 10.08 41 264731 25222 79454394
Drug eruption 13.51 10.08 213 264559 43722 79435894
Caesarean section 13.49 10.08 13 264759 12522 79467094
Chills 13.47 10.08 417 264355 159817 79319799
Meningitis streptococcal 13.43 10.08 8 264764 170 79479446
Organising pneumonia 13.42 10.08 10 264762 10929 79468687
Full blood count abnormal 13.42 10.08 79 264693 40395 79439221
Acquired cystic kidney disease 13.42 10.08 6 264766 68 79479548
Ocular hyperaemia 13.39 10.08 148 264624 28058 79451558
Colorectal cancer 13.32 10.08 6 264766 8641 79470975
Vaginal abscess 13.30 10.08 11 264761 401 79479215
Hypogammaglobulinaemia 13.29 10.08 14 264758 12937 79466679
Bacterial infection 13.27 10.08 56 264716 31224 79448392
Drug level below therapeutic 13.24 10.08 8 264764 9762 79469854
Breast cancer stage I 13.24 10.08 3 264769 6697 79472919
Blood pressure fluctuation 13.23 10.08 304 264468 66841 79412775
Joint ankylosis 13.23 10.08 25 264747 2155 79477461
Syndesmophyte 13.19 10.08 6 264766 71 79479545
Metabolic disorder 13.16 10.08 7 264765 9163 79470453
Splenomegaly 13.15 10.08 31 264741 20723 79458893
Lung infiltration 13.14 10.08 36 264736 22876 79456740
Metabolic encephalopathy 13.10 10.08 7 264765 9140 79470476
Neutrophilia 13.08 10.08 5 264767 7946 79471670
Eosinophilic pneumonia 12.97 10.08 43 264729 5267 79474349
Back disorder 12.91 10.08 74 264698 11504 79468112
Acute myocardial infarction 12.90 10.08 179 264593 76857 79402759
Complication associated with device 12.88 10.08 24 264748 17472 79462144
Aspiration 12.86 10.08 30 264742 20128 79459488
Hypertonia 12.84 10.08 4 264768 7228 79472388
Blood urea increased 12.82 10.08 102 264670 48688 79430928
Goitre 12.78 10.08 44 264728 5495 79474121
Abdominal distension 12.76 10.08 301 264471 119349 79360267
Hodgkin's disease 12.74 10.08 15 264757 845 79478771
Allodynia 12.72 10.08 21 264751 1627 79477989
Taste disorder 12.65 10.08 93 264679 15730 79463886
Premature labour 12.65 10.08 6 264766 8384 79471232
Diffuse large B-cell lymphoma 12.62 10.08 13 264759 12136 79467480
Spinal pain 12.61 10.08 91 264681 15301 79464315
Endometrial cancer stage I 12.61 10.08 8 264764 191 79479425
Pemphigus 12.61 10.08 426 264346 99156 79380460
Oral candidiasis 12.60 10.08 53 264719 29575 79450041
Lipidosis 12.60 10.08 5 264767 41 79479575
Atelectasis 12.56 10.08 163 264609 32094 79447522
Nephropathy toxic 12.54 10.08 31 264741 20388 79459228
Supraventricular tachycardia 12.52 10.08 33 264739 21237 79458379
Multiple sclerosis 12.51 10.08 121 264651 22161 79457455
Limb operation 12.47 10.08 32 264740 3394 79476222
Pneumothorax 12.46 10.08 50 264722 28273 79451343
Duodenitis 12.45 10.08 56 264716 7911 79471705
Pancreatitis acute 12.44 10.08 105 264667 49499 79430117
Pneumatosis intestinalis 12.37 10.08 3 264769 6394 79473222
Pre-eclampsia 12.32 10.08 4 264768 7037 79472579
Nerve compression 12.31 10.08 62 264710 9177 79470439
Mean cell haemoglobin decreased 12.29 10.08 47 264725 6177 79473439
Accidental overdose 12.22 10.08 79 264693 39502 79440114
Venous angioma of brain 12.19 10.08 5 264767 45 79479571
Granulocytopenia 12.14 10.08 12 264760 11419 79468197
Diabetes mellitus 12.13 10.08 185 264587 78205 79401411
Therapy cessation 12.10 10.08 74 264698 37488 79442128
Hepatitis cholestatic 12.07 10.08 17 264755 13835 79465781
Injection site reaction 12.05 10.08 252 264520 54533 79425083
Cardiac disorder 12.03 10.08 150 264622 65607 79414009
Ventricular hypokinesia 12.02 10.08 8 264764 9271 79470345
Glycosylated haemoglobin increased 12.02 10.08 29 264743 19231 79460385
Dermatitis exfoliative 11.93 10.08 11 264761 10818 79468798
Haemorrhage 11.83 10.08 222 264550 90896 79388720
Polymenorrhagia 11.82 10.08 5 264767 49 79479567
Adrenergic syndrome 11.79 10.08 7 264765 148 79479468
Congenital bowing of long bones 11.74 10.08 4 264768 20 79479596
Pseudomonal sepsis 11.74 10.08 3 264769 6171 79473445
Dysarthria 11.73 10.08 156 264616 67466 79412150
Enteritis 11.65 10.08 19 264753 14564 79465052
Helicobacter test positive 11.63 10.08 18 264754 1320 79478296
Cerebral ischaemia 11.60 10.08 12 264760 11183 79468433
Condition aggravated 11.54 10.08 1863 262909 499261 78980355
Exercise tolerance decreased 11.51 10.08 8 264764 9063 79470553
Hyperpyrexia 11.50 10.08 3 264769 6089 79473527
Escherichia sepsis 11.48 10.08 7 264765 8501 79471115
Hypothermia 11.43 10.08 38 264734 22708 79456908
Coronary arterial stent insertion 11.37 10.08 3 264769 6041 79473575
Cyanosis 11.37 10.08 44 264728 25138 79454478
Device malfunction 11.35 10.08 35 264737 21413 79458203
Small intestinal haemorrhage 11.34 10.08 35 264737 4128 79475488
Tendon rupture 11.31 10.08 74 264698 12052 79467564
Disturbance in attention 11.28 10.08 234 264538 50567 79429049
Frequent bowel movements 11.27 10.08 55 264717 29484 79450132
Unevaluable event 11.25 10.08 124 264648 55461 79424155
Intervertebral disc protrusion 11.24 10.08 124 264648 23497 79456119
Substance abuse 11.23 10.08 11 264761 10515 79469101
Tremor 11.23 10.08 456 264316 169627 79309989
Sputum discoloured 11.21 10.08 116 264656 21627 79457989
Chronic pigmented purpura 11.19 10.08 8 264764 234 79479382
Autoimmune haemolytic anaemia 11.17 10.08 7 264765 8373 79471243
Mean platelet volume decreased 11.15 10.08 27 264745 2763 79476853
Lip and/or oral cavity cancer 11.14 10.08 16 264756 1097 79478519
Polydipsia 11.13 10.08 4 264768 6601 79473015
Staphylococcal sepsis 11.02 10.08 20 264752 14706 79464910
Renal arteriosclerosis 11.00 10.08 9 264763 323 79479293
Haematocrit decreased 10.99 10.08 274 264498 61038 79418578
Libido increased 10.99 10.08 22 264750 1979 79477637
White blood cell count increased 10.92 10.08 178 264594 74455 79405161
Therapeutic product effect incomplete 10.90 10.08 575 264197 141070 79338546
Blood potassium increased 10.89 10.08 55 264717 29220 79450396
Nail disorder 10.85 10.08 72 264700 11780 79467836
Gynaecomastia 10.82 10.08 6 264766 7675 79471941
Vascular access complication 10.82 10.08 23 264749 2159 79477457
Gallbladder cholesterolosis 10.81 10.08 12 264760 634 79478982
Jaundice 10.80 10.08 119 264653 53230 79426386
Cervicobrachial syndrome 10.79 10.08 16 264756 1130 79478486
Retinal haemorrhage 10.76 10.08 7 264765 8210 79471406
Asthenia 10.75 10.08 1512 263260 510177 78969439
Metastases to central nervous system 10.75 10.08 24 264748 16351 79463265
Obstructive pancreatitis 10.73 10.08 14 264758 876 79478740
Foetal exposure during pregnancy 10.65 10.08 3 264769 5787 79473829
Mouth ulceration 10.65 10.08 183 264589 38211 79441405
Nausea 10.63 10.08 3440 261332 953756 78525860
Granuloma 10.58 10.08 55 264717 8242 79471374
Hemiplegia 10.55 10.08 21 264751 14918 79464698
Serotonin syndrome 10.55 10.08 97 264675 44930 79434686
Amylase increased 10.54 10.08 13 264759 11196 79468420
Alcoholic hangover 10.54 10.08 3 264769 7 79479609
Intervertebral disc degeneration 10.54 10.08 89 264683 15696 79463920
Tender joint count decreased 10.51 10.08 7 264765 182 79479434
Occult blood positive 10.48 10.08 48 264724 6835 79472781
Swollen joint count decreased 10.44 10.08 7 264765 184 79479432
Tandem gait test abnormal 10.44 10.08 5 264767 67 79479549
Endodontic procedure 10.38 10.08 26 264746 2717 79476899
Uterine perforation 10.38 10.08 45 264727 6258 79473358
Allergic respiratory disease 10.35 10.08 6 264766 121 79479495
Foetal death 10.34 10.08 7 264765 8037 79471579
Decubitus ulcer 10.29 10.08 23 264749 15664 79463952
Small intestinal obstruction 10.28 10.08 51 264721 27221 79452395
Stupor 10.23 10.08 5 264767 6867 79472749
Pulmonary congestion 10.16 10.08 136 264636 26964 79452652
Oesophageal ulcer 10.14 10.08 48 264724 6927 79472689
Device related sepsis 10.14 10.08 4 264768 6236 79473380
Oral pustule 10.12 10.08 8 264764 273 79479343
Concussion 10.12 10.08 60 264712 9443 79470173

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
500MG;EQ 85MG BASE TREXIMET CURRAX N021926 April 15, 2008 RX TABLET ORAL 7332183 Oct. 2, 2025 TREATMENT OF MIGRAINE
60MG;EQ 10MG BASE TREXIMET CURRAX N021926 May 14, 2015 DISCN TABLET ORAL 7332183 Oct. 2, 2025 ACUTE TREATMENT OF MIGRAINE
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10022344 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 10028925 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY REDUCTION OF FEVER
EQ 200MG BASE NAPROXEN SODIUM BIONPHARMA N021920 Feb. 17, 2006 OTC CAPSULE ORAL 11090280 March 3, 2026 TEMPORARY RELIEF OF MINOR ACHES AND PAINS
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
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
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
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
Aleve HUMAN OTC DRUG LABEL 1 0280-6010 TABLET 220 mg ORAL NDA 17 sections