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

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 1055 119141-88-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • esomeprazole magnesium dihydrate
  • esomeprazole
  • (S)-Esomeprazole
  • (S)-Omeprazole
  • (-)-Omeprazole
  • esomeprazole magnesium
  • esomeprazole sodium
  • nexium control
  • esomeprazole magnesium hydrate
  • esomeprazole strontium
The S-isomer of omeprazole.
  • Molecular weight: 345.42
  • Formula: C17H19N3O3S
  • CLOGP: 2.56
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 77.10
  • ALOGS: -2.98
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O
30 mg P
0.50 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.50 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) 5.79 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 53 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.85 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.83 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 2001 FDA ASTRAZENECA PHARMS

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
Chronic kidney disease 825.31 9.38 916 207677 38855 50357676
Pemphigus 435.56 9.38 13 208580 120153 50276378
Drug ineffective 426.19 9.38 1839 206754 817494 49579037
Maternal exposure during pregnancy 338.41 9.38 118 208475 159660 50236871
Glossodynia 323.29 9.38 46 208547 115523 50281008
Renal injury 321.62 9.38 274 208319 8337 50388194
Hand deformity 312.73 9.38 27 208566 100172 50296359
Systemic lupus erythematosus 300.97 9.38 102 208491 140520 50256011
Synovitis 288.36 9.38 77 208516 123788 50272743
End stage renal disease 259.32 9.38 204 208389 5533 50390998
Completed suicide 256.74 9.38 111 208482 131778 50264753
Contraindicated product administered 243.39 9.38 157 208436 148801 50247730
Acute kidney injury 242.68 9.38 1690 206903 226368 50170163
Anti-cyclic citrullinated peptide antibody positive 240.89 9.38 12 208581 70575 50325956
Alopecia 228.58 9.38 413 208180 244634 50151897
Wound 219.03 9.38 81 208512 105713 50290818
Pericarditis 209.41 9.38 36 208557 78653 50317878
Off label use 202.52 9.38 1139 207454 473287 49923244
Drug intolerance 182.10 9.38 395 208198 218709 50177822
Hepatocellular injury 180.41 9.38 357 208236 25590 50370941
Arthropathy 178.95 9.38 233 208360 157673 50238858
Rheumatoid factor positive 174.96 9.38 7 208586 49852 50346679
Cholestasis 172.42 9.38 346 208247 25055 50371476
Infusion related reaction 158.67 9.38 285 208308 169272 50227259
Carotid artery thrombosis 157.28 9.38 90 208503 1409 50395122
Duodenal ulcer perforation 154.83 9.38 8 208585 45603 50350928
Neurologic neglect syndrome 154.21 9.38 88 208505 1370 50395161
Cholecystitis chronic 152.94 9.38 194 208399 9475 50387056
Toxicity to various agents 150.68 9.38 416 208177 212083 50184448
Treatment failure 145.97 9.38 213 208380 137424 50259107
Adjustment disorder 142.23 9.38 94 208499 1925 50394606
Joint swelling 141.91 9.38 526 208067 244760 50151771
Interstitial lung disease 141.77 9.38 512 208081 52664 50343867
Exposure during pregnancy 139.72 9.38 176 208417 120839 50275692
Hyponatraemia 138.10 9.38 770 207823 95369 50301162
Swelling 132.37 9.38 407 208186 200465 50196066
Discomfort 128.93 9.38 154 208439 108226 50288305
Death 120.39 9.38 816 207777 324563 50071968
Therapeutic product effect decreased 118.20 9.38 239 208354 135811 50260720
Hepatic enzyme increased 117.95 9.38 243 208350 137137 50259394
Renal failure 117.16 9.38 797 207796 105836 50290695
Personality disorder 115.39 9.38 114 208479 4210 50392321
Helicobacter infection 111.69 9.38 33 208560 49669 50346862
Biliary dyskinesia 111.65 9.38 89 208504 2461 50394070
Muscle injury 110.47 9.38 12 208581 37099 50359432
Peripheral swelling 109.87 9.38 456 208137 205480 50191051
Folliculitis 108.73 9.38 16 208577 39209 50357322
Product use issue 107.85 9.38 290 208303 149185 50247346
Fatigue 100.44 9.38 2190 206403 705411 49691120
Hemiplegia 99.60 9.38 137 208456 7244 50389287
Product use in unapproved indication 95.11 9.38 210 208383 115609 50280922
Gastrooesophageal reflux disease 92.28 9.38 585 208008 75843 50320688
Abdominal discomfort 91.64 9.38 569 208024 231072 50165459
Agranulocytosis 88.34 9.38 240 208353 21181 50375350
Tubulointerstitial nephritis 84.50 9.38 191 208402 15020 50381511
Hypertensive nephropathy 83.98 9.38 41 208552 455 50396076
Dysphagia 81.34 9.38 573 208020 76945 50319586
Sensitisation 75.28 9.38 58 208535 1524 50395007
Eosinophilia 74.94 9.38 207 208386 18445 50378086
Inappropriate antidiuretic hormone secretion 74.09 9.38 166 208427 12977 50383554
Intentional product use issue 73.04 9.38 128 208465 76790 50319741
Toxic skin eruption 71.31 9.38 149 208444 11102 50385429
Hepatic cytolysis 69.47 9.38 122 208471 7981 50388550
Motor dysfunction 68.96 9.38 121 208472 7910 50388621
Rash maculo-papular 68.86 9.38 254 208339 26387 50370144
Hypomagnesaemia 66.90 9.38 229 208364 22927 50373604
Coordination abnormal 66.50 9.38 147 208446 11387 50385144
Sleep disorder due to general medical condition, insomnia type 65.17 9.38 24 208569 31423 50365108
Device expulsion 65 9.38 19 208574 28803 50367728
Affect lability 63.98 9.38 125 208468 8873 50387658
Abdominal pain upper 62.22 9.38 962 207631 158347 50238184
Lower respiratory tract infection 58.38 9.38 199 208394 95002 50301529
Polycystic ovaries 58.11 9.38 61 208532 2423 50394108
Blister 57.67 9.38 171 208422 85247 50311284
Gastritis 56.86 9.38 278 208315 32705 50363826
Gastric polyps 56.50 9.38 62 208531 2592 50393939
Drug reaction with eosinophilia and systemic symptoms 55.92 9.38 249 208344 28175 50368356
Hypocalcaemia 55.88 9.38 239 208354 26577 50369954
Hypersensitivity 55.40 9.38 593 208000 214568 50181963
Pain 55.26 9.38 1894 206699 577009 49819522
Ejection fraction 54.94 9.38 43 208550 1157 50395374
Bronchial neoplasm 53.64 9.38 29 208564 404 50396127
Acute generalised exanthematous pustulosis 52.76 9.38 115 208478 8823 50387708
Pleural fibrosis 52.10 9.38 67 208526 3317 50393214
Systemic lupus erythematosus rash 51.98 9.38 49 208544 1706 50394825
Hiatus hernia 51.76 9.38 180 208413 18164 50378367
C-reactive protein abnormal 51.58 9.38 25 208568 27784 50368747
Epigastric discomfort 51.12 9.38 89 208504 5781 50390750
Rash 51.08 9.38 1393 207200 436078 49960453
Ill-defined disorder 50.93 9.38 92 208501 54562 50341969
Sensory loss 50.83 9.38 104 208489 7634 50388897
Gallbladder injury 50.01 9.38 42 208551 1252 50395279
Rhinitis allergic 49.96 9.38 99 208494 7101 50389430
Presbyacusis 49.22 9.38 59 208534 2717 50393814
Abortion spontaneous 48.96 9.38 60 208533 41712 50354819
Gallbladder disorder 47.86 9.38 165 208428 16577 50379954
Pleural thickening 47.34 9.38 56 208537 2543 50393988
Pregnancy 47.13 9.38 32 208561 29545 50366986
Condition aggravated 47.02 9.38 902 207691 296156 50100375
Intentional overdose 46.77 9.38 119 208474 62385 50334146
Blood magnesium increased 45.88 9.38 58 208535 2822 50393709
Nephrectomy 45.04 9.38 33 208560 802 50395729
Nasopharyngitis 44.84 9.38 544 208049 192383 50204148
Rebound acid hypersecretion 44.69 9.38 23 208570 288 50396243
Nephrogenic anaemia 43.74 9.38 44 208549 1661 50394870
Nephropathy 43.57 9.38 78 208515 5180 50391351
Hemiparesis 42.79 9.38 180 208413 19868 50376663
Diabetic nephropathy 42.78 9.38 39 208554 1300 50395231
Nasal turbinate hypertrophy 41.96 9.38 29 208564 641 50395890
Osteosclerosis 41.82 9.38 61 208532 3406 50393125
Drug abuse 41.71 9.38 118 208475 59728 50336803
Loss of employment 40.82 9.38 41 208552 1545 50394986
Irritable bowel syndrome 40.80 9.38 95 208498 51346 50345185
Anxiety 40.73 9.38 989 207604 176617 50219914
Deafness neurosensory 40.19 9.38 69 208524 4432 50392099
Lung disorder 40.09 9.38 319 208274 44480 50352051
Bronchial disorder 39.93 9.38 35 208558 1107 50395424
Eating disorder 39.89 9.38 147 208446 15262 50381269
Knee arthroplasty 39.42 9.38 54 208539 35792 50360739
Gamma-glutamyltransferase increased 39.04 9.38 232 208361 29391 50367140
Prescription form tampering 38.94 9.38 26 208567 542 50395989
Bronchial haemorrhage 38.56 9.38 25 208568 495 50396036
Aphasia 38.10 9.38 224 208369 28270 50368261
Psoriatic arthropathy 37.99 9.38 86 208507 46946 50349585
Hip arthroplasty 37.49 9.38 42 208551 30387 50366144
Injection site erythema 36.82 9.38 171 208422 74765 50321766
Live birth 36.66 9.38 11 208582 16397 50380134
Anaemia 36.17 9.38 1326 207267 251130 50145401
Cholelithiasis 35.98 9.38 274 208319 37699 50358832
Premature delivery 35.87 9.38 27 208566 23636 50372895
Angina pectoris 35.74 9.38 207 208386 25981 50370550
Axonal neuropathy 35.73 9.38 30 208563 894 50395637
Pancreatitis 34.68 9.38 297 208296 42317 50354214
Dermatitis bullous 34.33 9.38 85 208508 7088 50389443
Cholecystitis 33.97 9.38 130 208463 13741 50382790
Asthma 33.90 9.38 537 208056 88800 50307731
Sleep apnoea syndrome 33.45 9.38 190 208403 23678 50372853
COVID-19 33.26 9.38 91 208502 46571 50349960
Hypokalaemia 33.04 9.38 528 208065 87464 50309067
Drug resistance 32.38 9.38 19 208574 18970 50377561
Vascular purpura 32.38 9.38 32 208561 1182 50395349
Drug hypersensitivity 31.67 9.38 790 207803 250220 50146311
Arterial occlusive disease 30.85 9.38 64 208529 4744 50391787
Caesarean section 30.66 9.38 13 208580 15626 50380905
Asthenia 30.65 9.38 1608 206985 317434 50079097
Gastric antral vascular ectasia 30.48 9.38 22 208571 522 50396009
Abdominal pain 30.33 9.38 1226 207367 235002 50161529
Red blood cell sedimentation rate abnormal 29.84 9.38 15 208578 16328 50380203
Tenosynovitis stenosans 29.59 9.38 41 208552 2183 50394348
Urate nephropathy 29.28 9.38 13 208580 114 50396417
Endometrial ablation 29.28 9.38 26 208567 837 50395694
Injection site pain 28.94 9.38 305 208288 110719 50285812
Dry mouth 28.71 9.38 356 208237 55822 50340709
Foetal exposure during pregnancy 28.33 9.38 43 208550 27316 50369215
Mobility decreased 28.23 9.38 203 208390 79745 50316786
Cholestatic liver injury 28.00 9.38 38 208555 1983 50394548
Dry eye 27.88 9.38 227 208366 31868 50364663
Fall 27.29 9.38 1663 206930 333269 50063262
Impaired healing 27.23 9.38 172 208421 69614 50326917
Iron deficiency anaemia 26.97 9.38 139 208454 16695 50379836
Cell death 26.76 9.38 39 208554 2176 50394355
No adverse event 26.63 9.38 62 208531 33516 50363015
Therapy non-responder 26.52 9.38 114 208479 50908 50345623
Bone cyst 26.46 9.38 37 208556 1987 50394544
Infection 26.46 9.38 528 208065 172426 50224105
Erythema dyschromicum perstans 26.32 9.38 10 208583 56 50396475
Nephritis allergic 26.26 9.38 13 208580 149 50396382
Rhabdomyolysis 26.20 9.38 261 208332 38766 50357765
Accidental exposure to product 26.10 9.38 34 208559 23023 50373508
Impaired work ability 25.71 9.38 118 208475 13522 50383009
Gastric disorder 25.67 9.38 209 208384 29339 50367192
Adverse drug reaction 25.39 9.38 129 208464 55093 50341438
Musculoskeletal stiffness 25.21 9.38 375 208218 128106 50268425
Pancreatitis acute 24.94 9.38 176 208417 23636 50372895
Hypothyroidism 24.77 9.38 232 208361 33893 50362638
Angina bullosa haemorrhagica 24.67 9.38 12 208581 132 50396399
Cross sensitivity reaction 24.27 9.38 35 208558 1934 50394597
Cutaneous lupus erythematosus 24.02 9.38 39 208554 2392 50394139
Chest pain 23.85 9.38 923 207670 175959 50220572
Anal abscess 23.78 9.38 50 208543 3741 50392790
Dysarthria 23.61 9.38 247 208346 37156 50359375
Phlebitis 23.49 9.38 64 208529 5656 50390875
Lip oedema 23.49 9.38 45 208548 3148 50393383
Therapeutic response decreased 23.06 9.38 108 208485 47123 50349408
Gallbladder polyp 23.03 9.38 21 208572 700 50395831
Occupational asthma 23.02 9.38 11 208582 116 50396415
Synovial fluid analysis 23.00 9.38 31 208562 1607 50394924
Nausea 22.62 9.38 3275 205318 702123 49694408
Malnutrition 22.61 9.38 111 208482 13078 50383453
Herpes simplex test positive 22.54 9.38 11 208582 122 50396409
Rheumatoid arthritis 22.26 9.38 650 207943 201900 50194631
Muscle haemorrhage 22.14 9.38 42 208551 2916 50393615
Poisoning 21.82 9.38 12 208581 12417 50384114
Arthralgia 21.80 9.38 1536 207057 437166 49959365
Hypergastrinaemia 21.74 9.38 10 208583 96 50396435
Hypocapnia 21.61 9.38 15 208578 334 50396197
Anaemia macrocytic 21.25 9.38 38 208555 2521 50394010
Cyst 21.20 9.38 103 208490 12084 50384447
Drug interaction 20.96 9.38 1015 207578 198606 50197925
Cerebral haematoma 20.90 9.38 43 208550 3168 50393363
Schizophreniform disorder 20.88 9.38 9 208584 73 50396458
Drug tolerance decreased 20.72 9.38 6 208587 9154 50387377
Renal impairment 20.67 9.38 432 208161 75229 50321302
Palpitations 20.66 9.38 523 208070 93983 50302548
Therapy interrupted 20.55 9.38 32 208561 20120 50376411
Febrile bone marrow aplasia 20.54 9.38 65 208528 6246 50390285
Haematoma 20.46 9.38 204 208389 30306 50366225
Neutropenic sepsis 20.36 9.38 17 208576 14130 50382401
Gallbladder hypofunction 20.21 9.38 17 208576 508 50396023
Stomatitis 20.15 9.38 295 208298 101049 50295482
Bursitis 20.01 9.38 158 208435 21977 50374554
Neurotoxicity 19.68 9.38 19 208574 14721 50381810
Cholecystectomy 19.44 9.38 83 208510 9220 50387311
Crepitations 19.29 9.38 63 208530 6156 50390375
Supraventricular extrasystoles 19.16 9.38 47 208546 3897 50392634
Chronic cutaneous lupus erythematosus 18.84 9.38 10 208583 134 50396397
Loss of personal independence in daily activities 18.83 9.38 191 208402 69859 50326672
Flatulence 18.81 9.38 195 208398 29263 50367268
Tetany 18.80 9.38 28 208565 1593 50394938
Mixed liver injury 18.79 9.38 43 208550 3408 50393123
Mesenteric panniculitis 18.66 9.38 9 208584 97 50396434
Dyspepsia 18.61 9.38 418 208175 73679 50322852
Muscle spasticity 18.58 9.38 128 208465 17056 50379475
Myelosuppression 18.54 9.38 17 208576 13500 50383031
Nephritic syndrome 18.53 9.38 11 208582 185 50396346
Scleritis 18.46 9.38 41 208552 3186 50393345
Carpal tunnel syndrome 18.36 9.38 126 208467 16767 50379764
Haematotoxicity 18.18 9.38 5 208588 7890 50388641
Hepatitis 18.13 9.38 204 208389 31249 50365282
Hepatitis cholestatic 18.11 9.38 61 208532 6056 50390475
Gastrointestinal motility disorder 18.07 9.38 50 208543 4459 50392072
Small cell carcinoma 18.03 9.38 10 208583 147 50396384
Injection site bruising 18.00 9.38 84 208509 36684 50359847
Blood alkaline phosphatase increased 17.98 9.38 235 208358 37291 50359240
Muscle swelling 17.91 9.38 14 208579 376 50396155
Injection site swelling 17.86 9.38 100 208493 41673 50354858
Rectosigmoid cancer 17.85 9.38 10 208583 150 50396381
Oesophageal dilatation 17.60 9.38 13 208580 320 50396211
Bradypnoea 17.52 9.38 39 208554 3035 50393496
Liver function test increased 17.46 9.38 51 208542 25555 50370976
Muscular weakness 17.42 9.38 514 208079 94499 50302032
Pneumobilia 17.40 9.38 9 208584 114 50396417
Congenital osteodystrophy 17.22 9.38 6 208587 25 50396506
Hyperchlorhydria 17.16 9.38 26 208567 1502 50395029
Injection site pruritus 17.14 9.38 97 208496 40314 50356217
Face oedema 17.05 9.38 129 208464 17710 50378821
Bone erosion 16.88 9.38 14 208579 11673 50384858
Electric shock 16.85 9.38 21 208572 1007 50395524
Osteopenia 16.80 9.38 124 208469 16894 50379637
Device dependence 16.71 9.38 5 208588 11 50396520
Bile duct stone 16.69 9.38 40 208553 3267 50393264
Hepatotoxicity 16.62 9.38 57 208536 27169 50369362
Livedo reticularis 16.46 9.38 31 208562 2141 50394390
Pathological fracture 16.41 9.38 69 208524 7613 50388918
Early satiety 16.37 9.38 18 208575 754 50395777
Anaemia folate deficiency 16.30 9.38 10 208583 179 50396352
Arterial spasm 16.11 9.38 7 208586 58 50396473
IIIrd nerve paresis 16.06 9.38 9 208584 135 50396396
Genital infection female 16.06 9.38 8 208585 93 50396438
Blood chromogranin A increased 15.96 9.38 11 208582 242 50396289
Normal newborn 15.86 9.38 4 208589 6687 50389844
International normalised ratio increased 15.84 9.38 258 208335 42894 50353637
Eczema 15.81 9.38 153 208440 22549 50373982
Gastrointestinal haemorrhage 15.80 9.38 405 208188 72916 50323615
Oesophageal polyp 15.76 9.38 4 208589 3 50396528
Renal disorder 15.68 9.38 178 208415 27327 50369204
Crohn's disease 15.64 9.38 49 208544 4684 50391847
Therapy partial responder 15.51 9.38 4 208589 6587 50389944
Escherichia pyelonephritis 15.49 9.38 13 208580 387 50396144
Kidney infection 15.43 9.38 131 208462 18615 50377916
Oesophagitis ulcerative 15.42 9.38 14 208579 464 50396067
Acute hepatitis B 15.33 9.38 12 208581 323 50396208
Muscle contractions involuntary 15.27 9.38 28 208565 1894 50394637
Skin lesion 15.25 9.38 173 208420 26554 50369977
Premature labour 15.08 9.38 15 208578 11461 50385070
Sinus congestion 15.07 9.38 104 208489 13867 50382664
Prothrombin time ratio decreased 15.05 9.38 13 208580 403 50396128
Angina unstable 14.93 9.38 61 208532 6645 50389886
Brucellosis 14.92 9.38 6 208587 40 50396491
Chondrocalcinosis pyrophosphate 14.91 9.38 20 208573 1032 50395499
Adenocarcinoma gastric 14.88 9.38 14 208579 486 50396045
Subacute cutaneous lupus erythematosus 14.82 9.38 30 208563 2185 50394346
Hyperthermia 14.82 9.38 67 208526 7629 50388902
Blood potassium increased 14.79 9.38 117 208476 16281 50380250
Keratoacanthoma 14.78 9.38 13 208580 413 50396118
Pancreatitis chronic 14.77 9.38 30 208563 2190 50394341
Granuloma skin 14.75 9.38 3 208590 5815 50390716
Clinically isolated syndrome 14.71 9.38 5 208588 19 50396512
Thymus disorder 14.59 9.38 10 208583 218 50396313
Oedema peripheral 14.49 9.38 793 207800 157168 50239363
Jaundice 14.16 9.38 169 208424 26260 50370271
Renal cyst 14.10 9.38 72 208521 8615 50387916
Adverse event 14.08 9.38 114 208479 43649 50352882
Gangrene 14.08 9.38 47 208546 4645 50391886
Neutropenia 14.03 9.38 484 208109 147481 50249050
Product dose omission issue 14.02 9.38 617 207976 183221 50213310
Haemoglobin decreased 14.01 9.38 650 207943 126566 50269965
Calcium metabolism disorder 13.99 9.38 8 208585 125 50396406
Purging 13.99 9.38 6 208587 48 50396483
Hyperparathyroidism secondary 13.81 9.38 22 208571 1328 50395203
Pre-eclampsia 13.78 9.38 8 208585 8036 50388495
Abortion induced 13.73 9.38 11 208582 9333 50387198
Meningitis aseptic 13.73 9.38 43 208550 4109 50392422
Bunion operation 13.71 9.38 20 208573 1117 50395414
Uveal melanoma 13.62 9.38 4 208589 8 50396523
Macular degeneration 13.60 9.38 24 208569 14364 50382167
Hepatic steatosis 13.54 9.38 157 208436 24227 50372304
Dehydration 13.53 9.38 763 207830 151686 50244845
Emotional distress 13.52 9.38 179 208414 28484 50368047
Lymphangiectasia 13.49 9.38 3 208590 0 50396531
Synovial cyst 13.48 9.38 68 208525 8098 50388433
Protein-losing gastroenteropathy 13.46 9.38 9 208584 188 50396343
Wrong technique in product usage process 13.46 9.38 155 208438 55355 50341176
Ejection fraction abnormal 13.40 9.38 17 208576 830 50395701
Photophobia 13.31 9.38 106 208487 14781 50381750
Dermatitis exfoliative 13.26 9.38 49 208544 5093 50391438
Vertigo 13.20 9.38 293 208300 51539 50344992
Infusion site scar 13.18 9.38 11 208582 325 50396206
Therapeutic response shortened 13.17 9.38 7 208586 7382 50389149
Vitamin B12 decreased 13.10 9.38 33 208560 2782 50393749
Musculoskeletal chest pain 13.08 9.38 125 208468 18361 50378170
Hyponatraemic seizure 13.06 9.38 12 208581 404 50396127
Gastrointestinal tract mucosal pigmentation 13.06 9.38 14 208579 570 50395961
Paranasal sinus inflammation 13.04 9.38 12 208581 405 50396126
Hypoplastic anaemia 13.01 9.38 4 208589 10 50396521
Renal tubular disorder 12.87 9.38 30 208563 2407 50394124
Rectal haemorrhage 12.86 9.38 227 208366 38331 50358200
Rhonchi 12.85 9.38 29 208564 2278 50394253
Lordosis 12.84 9.38 10 208583 267 50396264
Melaena 12.77 9.38 168 208425 26696 50369835
Renal haemangioma 12.74 9.38 5 208588 31 50396500
Transient ischaemic attack 12.73 9.38 195 208398 32015 50364516
Vulvovaginal inflammation 12.71 9.38 14 208579 588 50395943
Sedation 12.69 9.38 74 208519 30536 50365995
Drug ineffective for unapproved indication 12.69 9.38 45 208548 21236 50375295
Gastric cancer 12.63 9.38 34 208559 2984 50393547
Campylobacter colitis 12.60 9.38 5 208588 32 50396499
Haemorrhoids 12.58 9.38 127 208466 18926 50377605
Medication error 12.58 9.38 92 208501 36012 50360519
Device dislocation 12.55 9.38 46 208547 21500 50375031
Hyperlipasaemia 12.54 9.38 13 208580 509 50396022
Disease progression 12.53 9.38 300 208293 95566 50300965
Panniculitis 12.51 9.38 10 208583 8493 50388038
Resorption bone increased 12.50 9.38 18 208575 993 50395538
Monoclonal gammopathy 12.50 9.38 14 208579 599 50395932
Intestinal infarction 12.49 9.38 18 208575 994 50395537
Intentional self-injury 12.40 9.38 51 208542 23061 50373470
Bladder sphincter atony 12.40 9.38 8 208585 157 50396374
Cerebellar haematoma 12.39 9.38 11 208582 354 50396177
Body temperature increased 12.35 9.38 77 208516 31264 50365267
Congenital bowing of long bones 12.34 9.38 6 208587 66 50396465
Deformity 12.33 9.38 65 208528 7875 50388656
Rash scarlatiniform 12.26 9.38 7 208586 109 50396422
Hyperphosphatasaemia 12.25 9.38 4 208589 13 50396518
Renal atrophy 12.22 9.38 20 208573 1235 50395296
Type I hypersensitivity 12.20 9.38 29 208564 2356 50394175
Proteinuria 12.12 9.38 113 208480 16484 50380047
Rheumatoid nodule 12.12 9.38 92 208501 12643 50383888
Nerve injury 12.05 9.38 67 208526 8283 50388248
Tongue oedema 12.00 9.38 39 208554 3800 50392731
Heat stroke 11.95 9.38 14 208579 629 50395902
Malabsorption 11.91 9.38 38 208555 3668 50392863
Complication of device insertion 11.87 9.38 5 208588 6036 50390495
Colitis 11.86 9.38 224 208369 38305 50358226
Dialysis 11.85 9.38 73 208520 9365 50387166
Tooth infection 11.82 9.38 99 208494 14013 50382518
Contusion 11.82 9.38 362 208231 111821 50284710
Drug eruption 11.80 9.38 149 208444 23457 50373074
Gastrointestinal ischaemia 11.77 9.38 8 208585 172 50396359
Vitreous detachment 11.65 9.38 24 208569 1770 50394761
Hypoosmolar state 11.65 9.38 8 208585 175 50396356
Neurosis 11.63 9.38 9 208584 238 50396293
Aeromonas infection 11.60 9.38 6 208587 76 50396455
Respiratory tract congestion 11.57 9.38 99 208494 14100 50382431
Dermatosis 11.54 9.38 9 208584 241 50396290
Rectal cancer metastatic 11.54 9.38 9 208584 241 50396290
Unintentional medical device removal 11.51 9.38 4 208589 5431 50391100
Pleuritic pain 11.50 9.38 55 208538 6411 50390120
Vaginal haemorrhage 11.48 9.38 57 208536 24494 50372037
Poor personal hygiene 11.44 9.38 10 208583 315 50396216
Diverticulum 11.44 9.38 79 208514 10535 50385996
Gastric adenoma 11.42 9.38 3 208590 3 50396528
Platelet adhesiveness decreased 11.42 9.38 3 208590 3 50396528
Blood magnesium decreased 11.41 9.38 82 208511 11078 50385453
Respiratory depression 11.38 9.38 20 208573 11990 50384541
Hyperkalaemia 11.37 9.38 269 208324 47820 50348711
Coronary artery occlusion 11.36 9.38 61 208532 7442 50389089
Teeth brittle 11.34 9.38 12 208581 481 50396050
Sinus bradycardia 11.32 9.38 93 208500 13090 50383441
Malignant neoplasm progression 11.32 9.38 205 208388 67919 50328612
Seizure 11.31 9.38 385 208208 117489 50279042
Neoplasm progression 11.30 9.38 72 208521 29085 50367446
Immunodeficiency 11.27 9.38 28 208565 14800 50381731
Erosive oesophagitis 11.21 9.38 22 208571 1567 50394964
Hypofibrinogenaemia 11.21 9.38 18 208575 1094 50395437
Regurgitation 11.19 9.38 20 208573 1326 50395205
Respiratory arrest 11.18 9.38 75 208518 29934 50366597
Dystonia 11.17 9.38 20 208573 11906 50384625
Hypoparathyroidism 11.15 9.38 13 208580 581 50395950
Polyglandular autoimmune syndrome type II 11.15 9.38 5 208588 45 50396486
Muscle enzyme increased 11.14 9.38 7 208586 131 50396400
Thrombocytopenia 11.13 9.38 638 207955 127035 50269496
Enterocolitis haemorrhagic 11.08 9.38 20 208573 1337 50395194
Lumbar spinal stenosis 11.06 9.38 40 208553 4114 50392417
Transplant rejection 11.05 9.38 14 208579 9595 50386936
Blood thyroid stimulating hormone increased 10.97 9.38 52 208541 6040 50390491
Acute cutaneous lupus erythematosus 10.93 9.38 9 208584 261 50396270
Antinuclear antibody positive 10.90 9.38 53 208540 6219 50390312
Tachycardia paroxysmal 10.90 9.38 9 208584 262 50396269
Female sterilisation 10.89 9.38 12 208581 504 50396027
Concussion 10.87 9.38 61 208532 7567 50388964
Eructation 10.86 9.38 58 208535 7063 50389468
Vulval disorder 10.84 9.38 14 208579 696 50395835
Diverticulum oesophageal 10.82 9.38 7 208586 138 50396393
Musculoskeletal disorder 10.81 9.38 36 208557 17313 50379218
Atelectasis 10.76 9.38 119 208474 18151 50378380
Fibromyalgia 10.75 9.38 252 208341 44726 50351805
Oesophagitis 10.74 9.38 93 208500 13290 50383241
Lipase increased 10.69 9.38 66 208527 8475 50388056
Nikolsky's sign 10.65 9.38 6 208587 91 50396440
Purpura senile 10.65 9.38 12 208581 517 50396014
Purple glove syndrome 10.56 9.38 8 208585 205 50396326
Tongue pruritus 10.48 9.38 11 208582 437 50396094
Cholangitis 10.47 9.38 42 208551 4537 50391994
Colitis ischaemic 10.47 9.38 71 208522 9412 50387119
Gastric ulcer 10.45 9.38 134 208459 21171 50375360
Eye haematoma 10.44 9.38 4 208589 23 50396508
Maternal exposure before pregnancy 10.43 9.38 5 208588 5592 50390939
Faeces discoloured 10.42 9.38 107 208486 16017 50380514
Pancreatic neuroendocrine tumour 10.42 9.38 9 208584 279 50396252
Bicytopenia 10.41 9.38 24 208569 1912 50394619
Renal hypertension 10.40 9.38 7 208586 148 50396383
Respiratory syncytial virus infection 10.39 9.38 4 208589 5098 50391433
Peripheral artery thrombosis 10.36 9.38 22 208571 1658 50394873
Abdominal adhesions 10.33 9.38 30 208563 2750 50393781
Atrioventricular block complete 10.33 9.38 58 208535 7197 50389334
Cardiothoracic ratio increased 10.30 9.38 4 208589 24 50396507
Renal hypertrophy 10.30 9.38 4 208589 24 50396507
Placental calcification 10.30 9.38 4 208589 24 50396507
Weight increased 10.30 9.38 705 207888 201186 50195345
Acute coronary syndrome 10.24 9.38 70 208523 9304 50387227
Purpura 10.23 9.38 73 208520 9838 50386693
Laboratory test abnormal 10.22 9.38 55 208538 23153 50373378
Endometrial cancer stage III 10.22 9.38 3 208590 6 50396525
Face and mouth X-ray abnormal 10.22 9.38 3 208590 6 50396525
Diverticulum intestinal 10.22 9.38 50 208543 5883 50390648
Carnitine deficiency 10.20 9.38 7 208586 153 50396378
Device issue 10.15 9.38 45 208548 19927 50376604
Neuroleptic malignant syndrome 10.13 9.38 19 208574 11111 50385420
Hepatobiliary scan abnormal 10.12 9.38 5 208588 57 50396474
Dilatation atrial 10.09 9.38 23 208570 1818 50394713
Lichen planus 10.06 9.38 24 208569 1955 50394576
Vagus nerve disorder 10 9.38 6 208587 103 50396428
Dyslipidaemia 9.98 9.38 50 208543 5938 50390593
Oesophageal irritation 9.95 9.38 6 208587 104 50396427
Stent placement 9.93 9.38 34 208559 3404 50393127
Pulmonary artery stenosis 9.92 9.38 7 208586 160 50396371
Arterial fibrosis 9.90 9.38 3 208590 7 50396524
Portal vein dilatation 9.90 9.38 4 208589 27 50396504
Affective disorder 9.90 9.38 45 208548 5136 50391395
Sleep disorder due to a general medical condition 9.89 9.38 58 208535 7313 50389218
Unintended pregnancy 9.87 9.38 4 208589 4942 50391589
Septic shock 9.86 9.38 307 208286 56868 50339663
Tri-iodothyronine free decreased 9.85 9.38 9 208584 301 50396230
Vitamin B12 deficiency 9.84 9.38 37 208556 3879 50392652
Tonic clonic movements 9.80 9.38 18 208575 1219 50395312
Renal infarct 9.80 9.38 19 208574 1341 50395190
Cardiac arrest 9.80 9.38 266 208327 83385 50313146
Oedema mouth 9.78 9.38 26 208567 2264 50394267
Retinal artery occlusion 9.78 9.38 20 208573 1467 50395064
Job dissatisfaction 9.78 9.38 4 208589 28 50396503
Pyelonephritis acute 9.78 9.38 38 208555 4045 50392486
Fungal oesophagitis 9.72 9.38 12 208581 570 50395961
Thrombocytopenic purpura 9.71 9.38 18 208575 1228 50395303
Therapy cessation 9.69 9.38 65 208528 25946 50370585
Hepatic cirrhosis 9.68 9.38 113 208480 17464 50379067
Hunger 9.67 9.38 39 208554 4224 50392307
Giardiasis 9.66 9.38 4 208589 29 50396502
Cardio-respiratory arrest 9.65 9.38 160 208433 53732 50342799
Pulmonary arterial hypertension 9.63 9.38 127 208466 20192 50376339
Coma acidotic 9.61 9.38 6 208587 111 50396420
Dysgeusia 9.60 9.38 219 208374 38697 50357834
Small intestinal stenosis 9.56 9.38 11 208582 485 50396046
Renal lymphocele 9.55 9.38 5 208588 65 50396466
Haemoconcentration 9.55 9.38 5 208588 65 50396466
Renal tuberculosis 9.55 9.38 4 208589 30 50396501
Hepatic cancer recurrent 9.55 9.38 4 208589 30 50396501
Erythema multiforme 9.54 9.38 67 208526 8983 50387548
Rhinalgia 9.52 9.38 16 208577 1010 50395521
Burning sensation 9.49 9.38 250 208343 45196 50351335
Vomiting 9.46 9.38 2091 206502 458667 49937864
Atypical fracture 9.44 9.38 12 208581 587 50395944
Language disorder 9.43 9.38 22 208571 1766 50394765
Crystal arthropathy 9.40 9.38 8 208585 243 50396288
Fracture nonunion 9.39 9.38 25 208568 2179 50394352
Mandibular mass 9.38 9.38 7 208586 175 50396356

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
Chronic kidney disease 519.65 9.86 702 124020 35714 29414091
Toxicity to various agents 240.50 9.86 227 124495 173434 29276371
Death 200.03 9.86 756 123966 341328 29108477
End stage renal disease 193.32 9.86 198 124524 7466 29442339
Drug abuse 178.93 9.86 57 124665 79826 29369979
Acute kidney injury 168.14 9.86 1782 122940 263485 29186320
Drug ineffective 166.78 9.86 878 123844 362292 29087513
Completed suicide 165.54 9.86 87 124635 90159 29359646
Cholestasis 142.01 9.86 309 124413 23153 29426652
Hepatocellular injury 136.89 9.86 287 124435 20956 29428849
Toxic skin eruption 126.87 9.86 180 124542 9577 29440228
Off label use 126.53 9.86 748 123974 300052 29149753
Renal injury 125.04 9.86 183 124539 10019 29439786
Interstitial lung disease 124.59 9.86 528 124194 57190 29392615
Hypomagnesaemia 92.27 9.86 218 124504 17250 29432555
Hepatic cytolysis 91.30 9.86 142 124580 8205 29441600
Eosinophilia 88.56 9.86 249 124473 21912 29427893
Treatment failure 74.79 9.86 31 124691 36908 29412897
Hypocalcaemia 72.81 9.86 222 124500 20443 29429362
Agranulocytosis 72.12 9.86 219 124503 20121 29429684
Tubulointerstitial nephritis 61.65 9.86 189 124533 17454 29432351
Nephrogenic anaemia 60.72 9.86 57 124665 1928 29447877
Product use in unapproved indication 57.88 9.86 181 124541 86694 29363111
Renal failure 55.91 9.86 754 123968 117845 29331960
Drug reaction with eosinophilia and systemic symptoms 52.74 9.86 246 124476 27746 29422059
Foetal exposure during pregnancy 47.06 9.86 44 124678 33823 29415982
Hyperkalaemia 46.67 9.86 429 124293 60963 29388842
Gamma-glutamyltransferase increased 43.95 9.86 226 124496 26511 29423294
Hypertensive nephropathy 42.30 9.86 25 124697 407 29449398
Drug resistance 42.13 9.86 19 124703 21521 29428284
Occult blood 40.71 9.86 27 124695 543 29449262
Gastrooesophageal reflux disease 40.36 9.86 249 124473 31247 29418558
Degenerative mitral valve disease 38.97 9.86 19 124703 205 29449600
Pancreatitis acute 38.61 9.86 204 124518 24181 29425624
Hypergastrinaemia 37.06 9.86 13 124709 54 29449751
Nicotine dependence 37.06 9.86 24 124698 463 29449342
Thrombocytopenia 36.32 9.86 783 123939 134040 29315765
Rash maculo-papular 36.29 9.86 200 124522 24089 29425716
Pulmonary vascular disorder 35.68 9.86 25 124697 552 29449253
Hepatitis cholestatic 35.28 9.86 85 124637 6808 29442997
Lung disorder 35.18 9.86 234 124488 30128 29419677
Hepatojugular reflux 35.01 9.86 23 124699 455 29449350
Hyponatraemia 34.77 9.86 437 124285 67196 29382609
Cholestatic liver injury 34.29 9.86 39 124683 1658 29448147
COVID-19 33.47 9.86 63 124659 35951 29413854
Vascular purpura 33.14 9.86 35 124687 1368 29448437
Colitis microscopic 33.08 9.86 39 124683 1724 29448081
Hiatus hernia 32.17 9.86 81 124641 6671 29443134
Ventricular hypokinesia 32.14 9.86 64 124658 4501 29445304
Cell death 31.56 9.86 41 124681 2003 29447802
Mixed liver injury 31.45 9.86 41 124681 2010 29447795
Gastric polyps 31.28 9.86 29 124693 965 29448840
Drug intolerance 30.66 9.86 103 124619 48276 29401529
Jaundice 30.53 9.86 220 124502 29076 29420729
Product dose omission issue 29.93 9.86 261 124461 96122 29353683
Chronic kidney disease-mineral and bone disorder 29.68 9.86 19 124703 359 29449446
Eye injury 29.46 9.86 23 124699 602 29449203
Nephropathy 29.23 9.86 67 124655 5196 29444609
Idiopathic pulmonary fibrosis 28.04 9.86 49 124673 3119 29446686
Drug hypersensitivity 27.07 9.86 173 124549 68233 29381572
Systolic dysfunction 26.58 9.86 39 124683 2139 29447666
Intentional product use issue 26.58 9.86 91 124631 42407 29407398
Intentional overdose 26.54 9.86 79 124643 38449 29411356
Hypokalaemia 26.49 9.86 326 124396 49877 29399928
Hemiplegia 26.24 9.86 74 124648 6520 29443285
Gastric cancer 25.49 9.86 60 124662 4734 29445071
Electrocardiogram Q wave abnormal 25.15 9.86 16 124706 299 29449506
Physical deconditioning 25.00 9.86 23 124699 758 29449047
Ureteric compression 24.62 9.86 13 124709 168 29449637
Granulomatous rosacea 24.02 9.86 12 124710 137 29449668
Therapeutic product effect incomplete 24.01 9.86 85 124637 39220 29410585
Occupational dermatitis 23.99 9.86 10 124712 72 29449733
Therapy non-responder 23.82 9.86 60 124662 30851 29418954
Inferior vena cava dilatation 23.76 9.86 21 124701 656 29449149
Eczema 23.51 9.86 118 124604 13708 29436097
Diabetic nephropathy 23.23 9.86 34 124688 1861 29447944
Disease progression 23.19 9.86 227 124495 81689 29368116
Tubulointerstitial nephritis and uveitis syndrome 23.09 9.86 10 124712 80 29449725
Gastroenteritis eosinophilic 23.01 9.86 12 124710 151 29449654
Hypophosphataemic osteomalacia 22.86 9.86 11 124711 115 29449690
Eosinophilic colitis 22.81 9.86 13 124709 197 29449608
Helicobacter test positive 22.17 9.86 20 124702 642 29449163
Cholangitis 22.05 9.86 76 124646 7461 29442344
Ocular myasthenia 21.92 9.86 13 124709 213 29449592
Brain scan abnormal 21.50 9.86 22 124700 828 29448977
Hyperchlorhydria 21.17 9.86 19 124703 606 29449199
Hyperthermia 20.88 9.86 87 124635 9343 29440462
Acute generalised exanthematous pustulosis 20.62 9.86 61 124661 5522 29444283
Adverse drug reaction 20.62 9.86 44 124678 23976 29425829
Chest pain 20.58 9.86 618 124104 111355 29338450
Acute pulmonary oedema 20.39 9.86 69 124653 6710 29443095
Drug ineffective for unapproved indication 20.30 9.86 18 124704 14196 29435609
Pain 20.29 9.86 559 124163 170873 29278932
Cardiac failure 20.21 9.86 457 124265 78830 29370975
Fixed eruption 19.96 9.86 25 124697 1177 29448628
Overlap syndrome 19.87 9.86 9 124713 81 29449724
Rhabdomyolysis 19.63 9.86 363 124359 60445 29389360
Injection site pain 19.27 9.86 71 124651 32375 29417430
Peripheral swelling 19.16 9.86 174 124548 63565 29386240
Renal cyst 19.15 9.86 75 124647 7832 29441973
Device dependence 19.08 9.86 7 124715 34 29449771
Hyperkaliuria 18.63 9.86 9 124713 95 29449710
Anaemia 18.52 9.86 1030 123692 199921 29249884
Cardiac aneurysm 18.52 9.86 20 124702 802 29449003
Face oedema 18.36 9.86 89 124633 10194 29439611
Low birth weight baby 18.18 9.86 3 124719 6605 29443200
Cardiac arrest 18.10 9.86 253 124469 85338 29364467
Respiratory distress 18.03 9.86 211 124511 31895 29417910
Radiation pneumonitis 17.84 9.86 33 124689 2196 29447609
Contraindicated product administered 17.82 9.86 31 124691 18235 29431570
Inappropriate antidiuretic hormone secretion 17.68 9.86 92 124630 10840 29438965
Haematoma muscle 17.67 9.86 21 124701 936 29448869
Phaeochromocytoma malignant 17.67 9.86 8 124714 72 29449733
Anaemia macrocytic 17.50 9.86 36 124686 2592 29447213
Cross sensitivity reaction 17.47 9.86 24 124698 1238 29448567
Hepatic haematoma 17.47 9.86 14 124708 381 29449424
Circumoral oedema 17.46 9.86 7 124715 45 29449760
Acute coronary syndrome 17.42 9.86 100 124622 12225 29437580
Craniotabes 17.25 9.86 5 124717 9 29449796
Febrile bone marrow aplasia 17.21 9.86 69 124653 7282 29442523
Eosinophilic oesophagitis 17.18 9.86 11 124711 208 29449597
Premature baby 17.16 9.86 29 124693 17251 29432554
Therapy interrupted 17.03 9.86 7 124715 8379 29441426
Joint swelling 16.94 9.86 131 124591 49499 29400306
Multiple sclerosis relapse 16.87 9.86 14 124708 11405 29438400
Xerosis 16.80 9.86 15 124707 475 29449330
Hypovitaminosis 16.80 9.86 15 124707 475 29449330
No adverse event 16.75 9.86 30 124692 17448 29432357
Occupational exposure to air contaminants 16.73 9.86 9 124713 121 29449684
Immune-mediated hepatic disorder 16.73 9.86 13 124709 338 29449467
Anticoagulation drug level increased 16.70 9.86 15 124707 479 29449326
Haematotoxicity 16.43 9.86 4 124718 6695 29443110
Poisoning 16.37 9.86 11 124711 9982 29439823
Cardiac failure congestive 16.32 9.86 226 124496 76355 29373450
Oesophagitis ulcerative 16.12 9.86 17 124705 663 29449142
Pathogen resistance 16.12 9.86 7 124715 8109 29441696
Nerve degeneration 16.09 9.86 10 124712 179 29449626
Ischaemic stroke 16.08 9.86 119 124603 15858 29433947
Duodenitis 16.06 9.86 46 124676 4089 29445716
Antibody test abnormal 16.05 9.86 9 124713 132 29449673
Brief psychotic disorder with marked stressors 15.71 9.86 10 124712 187 29449618
Fatigue 15.47 9.86 1139 123583 315682 29134123
Hospitalisation 15.41 9.86 122 124600 45866 29403939
Venoocclusive liver disease 15.35 9.86 5 124717 6912 29442893
Immune reconstitution inflammatory syndrome 15.07 9.86 7 124715 7795 29442010
Aggression 15.04 9.86 88 124634 35453 29414352
Cerebral artery thrombosis 14.90 9.86 17 124705 725 29449080
Loss of personal independence in daily activities 14.89 9.86 56 124666 25384 29424421
Lethargy 14.88 9.86 95 124627 37485 29412320
Dermatitis exfoliative 14.80 9.86 60 124662 6365 29443440
Hyperkinetic heart syndrome 14.72 9.86 8 124714 110 29449695
Weight increased 14.69 9.86 231 124491 76436 29373369
Peripheral venous disease 14.46 9.86 31 124691 2297 29447508
Renal haemangioma 14.40 9.86 5 124717 20 29449785
Antiphospholipid antibodies positive 14.39 9.86 11 124711 279 29449526
Neuroleptic malignant syndrome 14.35 9.86 29 124693 16119 29433686
Cancer pain 14.29 9.86 31 124691 2316 29447489
High frequency ablation 14.20 9.86 9 124713 167 29449638
Oesophageal adenocarcinoma 14.13 9.86 17 124705 768 29449037
Respiratory depression 14.08 9.86 22 124700 13501 29436304
Neurotoxicity 14.08 9.86 25 124697 14588 29435217
Tachycardia 13.93 9.86 218 124504 72192 29377613
Stevens-Johnson syndrome 13.92 9.86 118 124604 16379 29433426
Prurigo 13.90 9.86 15 124707 601 29449204
Coronary artery stenosis 13.76 9.86 72 124650 8501 29441304
Accidental exposure to product 13.76 9.86 15 124707 10738 29439067
Fracture delayed union 13.65 9.86 6 124716 50 29449755
Muscle haemorrhage 13.64 9.86 38 124684 3324 29446481
Hepatic encephalopathy 13.64 9.86 98 124624 12937 29436868
Essential tremor 13.59 9.86 16 124706 706 29449099
Ventricular enlargement 13.58 9.86 13 124709 451 29449354
Thrombocytopenic purpura 13.54 9.86 19 124703 1000 29448805
Dyspepsia 13.53 9.86 190 124532 29935 29419870
Sacroiliitis 13.49 9.86 20 124702 1107 29448698
Bronchial injury 13.42 9.86 3 124719 0 29449805
Acquired cystic kidney disease 13.42 9.86 3 124719 0 29449805
Mitral valve incompetence 13.37 9.86 99 124623 13194 29436611
Benign abdominal neoplasm 13.36 9.86 7 124715 89 29449716
Vitamin B12 deficiency 13.30 9.86 37 124685 3234 29446571
Pancreatitis 13.29 9.86 212 124510 34302 29415503
Neutropenic sepsis 13.27 9.86 18 124704 11709 29438096
Hepatitis 13.22 9.86 140 124582 20643 29429162
Crohn's disease 13.20 9.86 35 124687 2974 29446831
Oesophageal dilatation 13.18 9.86 8 124714 137 29449668
Hypotension 13.09 9.86 678 124044 193676 29256129
Rebound acid hypersecretion 13.02 9.86 7 124715 94 29449711
Excessive cerumen production 12.93 9.86 10 124712 258 29449547
Prostatitis Escherichia coli 12.90 9.86 5 124717 29 29449776
Mucormycosis 12.81 9.86 3 124719 5155 29444650
Dermatitis bullous 12.70 9.86 54 124668 5852 29443953
Blood alkaline phosphatase increased 12.70 9.86 179 124543 28227 29421578
Chest expansion decreased 12.69 9.86 8 124714 147 29449658
Respiratory arrest 12.58 9.86 61 124661 25772 29424033
Myoglobinaemia 12.52 9.86 7 124715 102 29449703
Eructation 12.25 9.86 41 124681 3965 29445840
Ventricular arrhythmia 12.24 9.86 45 124677 4559 29445246
Sensitisation 12.19 9.86 8 124714 158 29449647
Bicytopenia 12.13 9.86 25 124697 1802 29448003
Abdominal pain upper 12.11 9.86 340 124382 60653 29389152
Exposure during pregnancy 12.01 9.86 11 124711 8543 29441262
Renal tubular disorder 11.97 9.86 43 124679 4309 29445496
Cholecystitis 11.96 9.86 73 124649 9124 29440681
Intestinal obstruction 11.87 9.86 129 124593 19148 29430657
Jaundice cholestatic 11.83 9.86 42 124680 4184 29445621
Psychotic disorder 11.78 9.86 45 124677 20309 29429496
Sepsis 11.76 9.86 487 124235 142195 29307610
Myelosuppression 11.70 9.86 21 124701 12206 29437599
Lumbar radiculopathy 11.66 9.86 15 124707 726 29449079
Hyperparathyroidism secondary 11.65 9.86 20 124702 1255 29448550
Intentional product misuse 11.59 9.86 92 124630 34569 29415236
Febrile neutropenia 11.52 9.86 373 124349 111867 29337938
Microcytic anaemia 11.44 9.86 26 124696 2005 29447800
Toxic epidermal necrolysis 11.42 9.86 122 124600 18031 29431774
Progressive multifocal leukoencephalopathy 11.34 9.86 12 124710 8707 29441098
Oral pustule 11.32 9.86 9 124713 242 29449563
Septic arthritis staphylococcal 11.32 9.86 12 124710 471 29449334
Poisoning deliberate 11.29 9.86 5 124717 5726 29444079
Essential hypertension 11.24 9.86 29 124693 2424 29447381
Renal atrophy 11.21 9.86 18 124704 1069 29448736
Carotid arteriosclerosis 11.15 9.86 21 124701 1417 29448388
Erythema of eyelid 11.10 9.86 14 124708 664 29449141
Carbohydrate antigen 19-9 increased 11.10 9.86 8 124714 185 29449620
Synovitis 11.07 9.86 18 124704 10872 29438933
Conjunctival ulcer 11.04 9.86 5 124717 45 29449760
Acute graft versus host disease in skin 11.03 9.86 3 124719 4661 29445144
Cardiorenal syndrome 10.97 9.86 14 124708 672 29449133
Musculoskeletal stiffness 10.93 9.86 103 124619 37355 29412450
Sudden death 10.91 9.86 99 124623 14011 29435794
Injection site reaction 10.90 9.86 19 124703 11169 29438636
Hyperplastic cholecystopathy 10.89 9.86 3 124719 4 29449801
Septic shock 10.87 9.86 343 124379 62217 29387588
Food interaction 10.82 9.86 16 124706 884 29448921
Bronchomalacia 10.76 9.86 6 124716 87 29449718
Unresponsive to stimuli 10.74 9.86 62 124660 25064 29424741
Nephropathy toxic 10.73 9.86 18 124704 10738 29439067
Heat stroke 10.70 9.86 16 124706 893 29448912
Laboratory test abnormal 10.66 9.86 40 124682 18145 29431660
Enterochromaffin cell hyperplasia 10.65 9.86 4 124718 21 29449784
Gastric cancer stage 0 10.65 9.86 4 124718 21 29449784
Hypercalciuria 10.60 9.86 9 124713 266 29449539
Drug dependence 10.53 9.86 49 124673 20932 29428873
Anal erosion 10.50 9.86 4 124718 22 29449783
Hypotrichosis 10.50 9.86 4 124718 22 29449783
Abnormal behaviour 10.47 9.86 56 124666 23071 29426734
Infective exacerbation of chronic obstructive airways disease 10.28 9.86 22 124700 1628 29448177
Coombs negative haemolytic anaemia 10.25 9.86 7 124715 148 29449657
Hyperphosphatasaemia 10.21 9.86 4 124718 24 29449781
Malnutrition 10.17 9.86 80 124642 10861 29438944
Microcytosis 10.17 9.86 7 124715 150 29449655
Platelet toxicity 10.15 9.86 3 124719 6 29449799
Barrett's oesophagus 10.15 9.86 11 124711 443 29449362
Renal mass 10.14 9.86 21 124701 1519 29448286
Creatinine renal clearance abnormal 10.13 9.86 8 124714 213 29449592
Drug interaction 10.11 9.86 965 123757 196420 29253385
Diverticulum 10.04 9.86 53 124669 6279 29443526
Hepatotoxicity 10.02 9.86 40 124682 17827 29431978
Duodenal polyp 9.97 9.86 7 124715 155 29449650
Epstein-Barr virus infection 9.95 9.86 8 124714 6621 29443184
Biliary anastomosis complication 9.93 9.86 6 124716 102 29449703
Nasal crusting 9.89 9.86 10 124712 371 29449434
Haemorrhage intracranial 9.88 9.86 30 124692 14512 29435293
Hepatocellular carcinoma 9.88 9.86 57 124665 6981 29442824
Oesophageal candidiasis 9.87 9.86 37 124685 3784 29446021

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
Chronic kidney disease 570.04 9.30 935 269183 56984 64171630
Completed suicide 442.35 9.30 193 269925 224221 64004393
Drug ineffective 374.67 9.30 2033 268085 838214 63390400
Toxicity to various agents 369.05 9.30 596 269522 362917 63865697
Hepatocellular injury 304.88 9.30 620 269498 44615 64183999
Cholestasis 287.11 9.30 602 269516 44270 64184344
Interstitial lung disease 275.12 9.30 968 269150 96764 64131850
Acute kidney injury 246.95 9.30 2920 267198 446320 63782294
Death 245.84 9.30 1113 269005 481592 63747022
Off label use 238.28 9.30 1613 268505 631193 63597421
Drug abuse 216.57 9.30 144 269974 132230 64096384
Synovitis 211.89 9.30 75 270043 99015 64129599
End stage renal disease 206.72 9.30 237 269881 10238 64218376
Pemphigus 191.33 9.30 17 270101 60684 64167930
Toxic skin eruption 174.54 9.30 300 269818 18984 64209630
Hand deformity 174.54 9.30 27 270091 62744 64165870
Maternal exposure during pregnancy 166.93 9.30 97 270021 95787 64132827
Anti-cyclic citrullinated peptide antibody positive 158.62 9.30 13 270105 49549 64179065
Eosinophilia 157.15 9.30 431 269687 37645 64190969
Carotid artery thrombosis 150.98 9.30 94 270024 1701 64226913
Hypomagnesaemia 150.22 9.30 419 269699 36957 64191657
Agranulocytosis 150.15 9.30 425 269693 37804 64190810
Hyponatraemia 148.44 9.30 1097 269021 147242 64081372
Neurologic neglect syndrome 144.41 9.30 88 270030 1530 64227084
Cholecystitis chronic 136.25 9.30 181 269937 9106 64219508
Glossodynia 133.20 9.30 52 270066 64644 64163970
Hypocalcaemia 131.90 9.30 430 269688 41323 64187291
Product use in unapproved indication 127.31 9.30 351 269767 176267 64052347
Systemic lupus erythematosus 119.57 9.30 90 270028 77522 64151092
Hemiplegia 118.67 9.30 201 269917 12567 64216047
Rheumatoid factor positive 118.08 9.30 7 270111 34931 64193683
Adjustment disorder 115.03 9.30 94 270024 2651 64225963
Drug intolerance 114.70 9.30 403 269715 187589 64041025
Duodenal ulcer perforation 113.86 9.30 8 270110 34617 64193997
Treatment failure 113.19 9.30 197 269921 116619 64111995
Contraindicated product administered 112.74 9.30 173 269945 107656 64120958
Alopecia 111.58 9.30 340 269778 165350 64063264
Wound 108.71 9.30 96 270022 76381 64152233
Renal injury 108.13 9.30 215 269903 15214 64213400
Renal failure 103.87 9.30 1191 268927 180497 64048117
Arthropathy 103.25 9.30 220 269898 120747 64107867
Biliary dyskinesia 103.14 9.30 83 270035 2289 64226325
Joint swelling 100.92 9.30 511 269607 214871 64013743
Gastrooesophageal reflux disease 99.76 9.30 643 269475 82500 64146114
Rash maculo-papular 98.94 9.30 425 269693 46601 64182013
Personality disorder 98.77 9.30 110 270008 4601 64224013
Hepatic cytolysis 98.73 9.30 196 269922 13853 64214761
Tubulointerstitial nephritis 95.53 9.30 316 269802 30593 64198021
Drug reaction with eosinophilia and systemic symptoms 94.06 9.30 463 269655 53754 64174860
Pericarditis 89.43 9.30 78 270040 62438 64166176
Infusion related reaction 89.04 9.30 370 269748 164097 64064517
Peripheral swelling 86.58 9.30 517 269601 208636 64019978
Intentional overdose 80.63 9.30 159 269959 89785 64138829
Intentional product use issue 80.08 9.30 175 269943 95189 64133425
Exposure during pregnancy 79.87 9.30 126 269992 77549 64151065
Sensitisation 78.32 9.30 62 270056 1669 64226945
Nephrogenic anaemia 77.32 9.30 82 270036 3243 64225371
Gamma-glutamyltransferase increased 76.27 9.30 403 269715 48107 64180507
Drug resistance 74.28 9.30 27 270091 35075 64193539
Inappropriate antidiuretic hormone secretion 72.60 9.30 232 269886 22057 64206557
Gastric polyps 72.30 9.30 75 270043 2890 64225724
Acute generalised exanthematous pustulosis 70.23 9.30 171 269947 13887 64214727
Swelling 70.06 9.30 389 269729 159829 64068785
Vascular purpura 66.59 9.30 67 270051 2489 64226125
Lung disorder 66.51 9.30 459 269659 60241 64168373
Dysphagia 66.39 9.30 712 269406 106100 64122514
Folliculitis 65.59 9.30 22 270096 30055 64198559
Helicobacter infection 65.07 9.30 40 270078 38322 64190292
Discomfort 64.19 9.30 153 269965 80725 64147889
Abdominal pain upper 63.83 9.30 1059 269059 173971 64054643
Muscle injury 63.78 9.30 16 270102 26421 64202193
Hiatus hernia 63.44 9.30 206 269912 19751 64208863
Hypertensive nephropathy 63.16 9.30 41 270077 800 64227814
Polycystic ovaries 60.80 9.30 59 270059 2096 64226518
Fatigue 59.73 9.30 2547 267571 746183 63482431
Hepatic enzyme increased 58.73 9.30 312 269806 129631 64098983
Therapeutic product effect decreased 58.45 9.30 266 269852 115085 64113529
Hypokalaemia 57.08 9.30 770 269348 121133 64107481
Ejection fraction 55.92 9.30 45 270073 1241 64227373
Cholestatic liver injury 54.42 9.30 72 270046 3607 64225007
Motor dysfunction 53.29 9.30 135 269983 11238 64217376
Hypergastrinaemia 52.97 9.30 22 270096 158 64228456
Pancreatitis acute 52.97 9.30 334 269784 42521 64186093
Bronchial neoplasm 52.59 9.30 29 270089 414 64228200
Affect lability 49.96 9.30 114 270004 8876 64219738
Anaemia 49.05 9.30 1995 268123 376685 63851929
Rhinitis allergic 48.90 9.30 106 270012 7972 64220642
Pancreatitis 47.68 9.30 419 269699 59188 64169426
Hyperkalaemia 47.43 9.30 639 269479 100490 64128124
Gastritis 47.11 9.30 323 269795 42295 64186319
C-reactive protein abnormal 46.93 9.30 32 270086 29015 64199599
Hepatitis cholestatic 46.61 9.30 134 269984 12021 64216593
COVID-19 46.48 9.30 130 269988 65010 64163604
Product use issue 45.43 9.30 411 269707 151304 64077310
Presbyacusis 45.40 9.30 55 270063 2520 64226094
Gallbladder disorder 44.73 9.30 165 269953 16865 64211749
Mixed liver injury 44.10 9.30 81 270037 5400 64223214
Thrombocytopenia 43.95 9.30 1238 268880 222563 64006051
Sleep disorder due to general medical condition, insomnia type 43.71 9.30 28 270090 26242 64202372
Injection site pain 43.66 9.30 280 269838 111128 64117486
Therapeutic response decreased 43.61 9.30 96 270022 52092 64176522
Device expulsion 43.48 9.30 17 270101 21119 64207495
Cell death 43.34 9.30 68 270050 3986 64224628
Therapy non-responder 42.37 9.30 138 269980 65761 64162853
Systemic lupus erythematosus rash 42.07 9.30 40 270078 1385 64227229
Coordination abnormal 41.87 9.30 148 269970 14816 64213798
Dermatitis bullous 41.59 9.30 128 269990 11926 64216688
Jaundice 41.42 9.30 346 269772 48166 64180448
Pregnancy 40.95 9.30 18 270100 20847 64207767
Pleural thickening 40.03 9.30 53 270065 2657 64225957
Sensory loss 39.87 9.30 113 270005 10056 64218558
Epigastric discomfort 39.67 9.30 88 270030 6723 64221891
Cross sensitivity reaction 39.55 9.30 59 270059 3308 64225306
Psoriatic arthropathy 39.22 9.30 76 270042 43205 64185409
Pain 38.94 9.30 1908 268210 551603 63677011
Nephropathy 38.73 9.30 99 270019 8287 64220327
Cardiac arrest 38.41 9.30 436 269682 153628 64074986
Condition aggravated 38.28 9.30 1228 268890 371198 63857416
Cholecystitis 37.91 9.30 173 269945 19463 64209151
Rhabdomyolysis 37.57 9.30 566 269552 91160 64137454
Gallbladder injury 37.32 9.30 34 270084 1114 64227500
Angina pectoris 37.15 9.30 319 269799 44762 64183852
Poisoning 36.85 9.30 23 270095 21856 64206758
Degenerative mitral valve disease 36.62 9.30 19 270099 238 64228376
Lower respiratory tract infection 36.46 9.30 239 269879 94375 64134239
Nasal turbinate hypertrophy 35.91 9.30 25 270093 550 64228064
Cardiac failure 35.82 9.30 765 269353 131608 64097006
Neutropenic sepsis 35.81 9.30 27 270091 23245 64205369
Loss of employment 35.71 9.30 42 270076 1865 64226749
Hypersensitivity 35.66 9.30 593 269525 195859 64032755
Device dependence 35.46 9.30 12 270106 44 64228570
Pleural fibrosis 35.33 9.30 62 270056 3988 64224626
Therapy interrupted 35.24 9.30 20 270098 20016 64208598
Accidental exposure to product 35.21 9.30 35 270083 26329 64202285
Nephrectomy 34.73 9.30 36 270082 1386 64227228
Iron deficiency anaemia 34.50 9.30 182 269936 21707 64206907
Hypothyroidism 34.24 9.30 288 269830 40169 64188445
Ill-defined disorder 32.87 9.30 86 270032 43966 64184648
Haematotoxicity 32.71 9.30 7 270111 12889 64215725
Nasopharyngitis 32.66 9.30 601 269517 195472 64033142
Osteosclerosis 32.55 9.30 55 270063 3431 64225183
Sedation complication 32.35 9.30 3 270115 10351 64218263
Eczema 32.11 9.30 224 269894 29496 64199118
Muscle haemorrhage 32.02 9.30 73 270045 5680 64222934
Respiratory arrest 31.99 9.30 114 270004 52871 64175743
Diabetic nephropathy 31.89 9.30 47 270071 2607 64226007
Hepatitis 31.71 9.30 311 269807 45271 64183343
Blood magnesium increased 31.54 9.30 52 270066 3179 64225435
Chronic kidney disease-mineral and bone disorder 31.41 9.30 22 270096 489 64228125
Abdominal discomfort 31.26 9.30 556 269562 181766 64046848
Cholangitis 31.23 9.30 108 270010 10694 64217920
Eating disorder 30.93 9.30 146 269972 16659 64211955
Hepatojugular reflux 30.79 9.30 22 270096 505 64228109
Premature delivery 30.68 9.30 20 270098 18569 64210045
Endometrial ablation 30.60 9.30 26 270092 775 64227839
Neurotoxicity 30.56 9.30 42 270076 27362 64201252
Idiopathic pulmonary fibrosis 30.37 9.30 56 270062 3744 64224870
Drug hypersensitivity 30.03 9.30 762 269356 237053 63991561
Drug ineffective for unapproved indication 29.69 9.30 53 270065 31080 64197534
Urate nephropathy 29.56 9.30 14 270104 142 64228472
Mobility decreased 28.63 9.30 226 269892 85614 64143000
Occupational dermatitis 28.60 9.30 13 270105 119 64228495
Tenosynovitis stenosans 28.44 9.30 38 270080 1922 64226692
Chest pain 28.40 9.30 1234 268884 234746 63993868
Myelosuppression 28.13 9.30 35 270083 23795 64204819
Bone erosion 28.00 9.30 7 270111 11588 64217026
Disease progression 27.94 9.30 421 269697 141259 64087355
Irritable bowel syndrome 27.84 9.30 73 270045 37296 64191318
Injection site erythema 27.70 9.30 178 269940 70622 64157992
Oesophagitis ulcerative 27.69 9.30 26 270092 886 64227728
Gastric cancer 27.28 9.30 74 270044 6419 64222195
Post transplant lymphoproliferative disorder 26.77 9.30 4 270114 9540 64219074
Hip arthroplasty 26.66 9.30 30 270088 21321 64207293
Blister 26.62 9.30 214 269904 80753 64147861
Occult blood 26.45 9.30 31 270087 1371 64227243
Musculoskeletal stiffness 26.44 9.30 360 269758 122846 64105768
Dry eye 26.40 9.30 210 269908 28809 64199805
Red blood cell sedimentation rate abnormal 26.29 9.30 18 270100 16288 64212326
Anaemia macrocytic 25.81 9.30 57 270061 4341 64224273
Gallbladder polyp 25.79 9.30 25 270093 887 64227727
Erythema dyschromicum perstans 25.73 9.30 10 270108 59 64228555
Knee arthroplasty 25.71 9.30 46 270072 26953 64201661
Hyperthermia 25.69 9.30 131 269987 15419 64213195
Respiratory distress 25.49 9.30 333 269785 51998 64176616
Pulmonary vascular disorder 25.40 9.30 25 270093 904 64227710
Neuroleptic malignant syndrome 25.26 9.30 41 270077 24955 64203659
Bone cyst 25.10 9.30 38 270080 2159 64226455
Respiratory depression 25.08 9.30 37 270081 23406 64205208
Sleep apnoea syndrome 25.05 9.30 212 269906 29620 64198994
Cholelithiasis 24.93 9.30 296 269822 45210 64183404
Axonal neuropathy 24.85 9.30 33 270085 1659 64226955
Hepatotoxicity 24.79 9.30 85 270033 39877 64188737
Bronchial disorder 24.76 9.30 37 270081 2078 64226536
Bronchial haemorrhage 24.71 9.30 28 270090 1194 64227420
Ureteric compression 24.57 9.30 13 270105 170 64228444
Weight increased 24.47 9.30 693 269425 212655 64015959
Nicotine dependence 24.32 9.30 23 270095 791 64227823
Aphasia 24.16 9.30 270 269848 40636 64187978
Tetany 24.01 9.30 37 270081 2135 64226479
Injection site pruritus 23.77 9.30 80 270038 37746 64190868
Lip oedema 23.69 9.30 61 270057 5128 64223486
Synovial fluid analysis 23.66 9.30 31 270087 1538 64227076
Abdominal pain 23.64 9.30 1564 268554 310811 63917803
Face oedema 23.53 9.30 181 269937 24580 64204034
Blood alkaline phosphatase increased 23.32 9.30 348 269770 55931 64172683
Caesarean section 23.30 9.30 9 270109 11265 64217349
Febrile bone marrow aplasia 23.11 9.30 101 270017 11154 64217460
Hemiparesis 22.99 9.30 208 269910 29619 64198995
Malnutrition 22.98 9.30 148 269970 18977 64209637
Laboratory test abnormal 22.91 9.30 41 270077 24022 64204592
Injection site bruising 22.81 9.30 77 270041 36296 64192318
Aggression 22.59 9.30 108 270010 46124 64182490
Medication error 22.54 9.30 120 269998 49846 64178768
Colitis microscopic 22.09 9.30 75 270043 7357 64221257
Abortion spontaneous 22.05 9.30 45 270073 25098 64203516
Rash 22.01 9.30 1638 268480 456911 63771703
Inferior vena cava dilatation 21.95 9.30 21 270097 733 64227881
Pyelocaliectasis 21.89 9.30 22 270096 816 64227798
Phlebitis 21.89 9.30 77 270041 7689 64220925
Carpal tunnel syndrome 21.87 9.30 127 269991 15701 64212913
Chronic cutaneous lupus erythematosus 21.80 9.30 13 270105 217 64228397
Cerebral haematoma 21.79 9.30 73 270045 7112 64221502
Acute coronary syndrome 21.72 9.30 147 269971 19163 64209451
Eosinophilic colitis 21.68 9.30 16 270102 387 64228227
Pathogen resistance 21.38 9.30 13 270105 12530 64216084
Dermatitis exfoliative 21.34 9.30 93 270025 10259 64218355
Helicobacter test positive 21.05 9.30 24 270094 1030 64227584
Hypovitaminosis 20.83 9.30 22 270096 866 64227748
Mucormycosis 20.76 9.30 3 270115 7338 64221276
Hyperparathyroidism secondary 20.76 9.30 36 270082 2294 64226320
Product dose omission issue 20.73 9.30 639 269479 194108 64034506
Unresponsive to stimuli 20.59 9.30 125 269993 50268 64178346
Injection site swelling 20.56 9.30 96 270022 41257 64187357
Deafness neurosensory 20.44 9.30 66 270052 6308 64222306
Hyperchlorhydria 20.39 9.30 31 270087 1768 64226846
Osteopenia 20.38 9.30 123 269995 15417 64213197
Granulomatous rosacea 20.29 9.30 12 270106 197 64228417
Hepatic haematoma 20.29 9.30 21 270097 807 64227807
Drug interaction 20.24 9.30 1770 268348 360313 63868301
Bicytopenia 20.20 9.30 46 270072 3576 64225038
Rectosigmoid cancer 20.19 9.30 13 270105 250 64228364
Febrile neutropenia 20.15 9.30 615 269503 187042 64041572
Renal cyst 20.14 9.30 105 270013 12465 64216149
Dyspepsia 20.08 9.30 459 269659 79853 64148761
Arterial occlusive disease 20.05 9.30 70 270048 6963 64221651
Muscle spasticity 20.03 9.30 129 269989 16540 64212074
Anxiety 19.97 9.30 1039 269079 201610 64027004
Live birth 19.97 9.30 11 270107 11193 64217421
Therapy partial responder 19.86 9.30 9 270109 10239 64218375
Immune reconstitution inflammatory syndrome 19.80 9.30 14 270104 12456 64216158
Sudden death 19.71 9.30 148 269970 19948 64208666
Loss of personal independence in daily activities 19.67 9.30 201 269917 72253 64156361
Rebound acid hypersecretion 19.65 9.30 9 270109 84 64228530
Palpitations 19.65 9.30 575 269543 103913 64124701
Campylobacter colitis 19.47 9.30 7 270111 32 64228582
Heat stroke 19.29 9.30 27 270091 1428 64227186
Gastric disorder 19.24 9.30 197 269921 29000 64199614
Drug dependence 19.24 9.30 73 270045 33239 64195375
Bunion operation 19.23 9.30 20 270098 773 64227841
Electrocardiogram Q wave abnormal 19.23 9.30 15 270103 395 64228219
Muscle contractions involuntary 19.23 9.30 42 270076 3175 64225439
Scleritis 19.20 9.30 40 270078 2926 64225688
Stomatitis 19.17 9.30 333 269785 109272 64119342
Acute pulmonary oedema 19.17 9.30 105 270013 12704 64215910
Adverse drug reaction 18.98 9.30 112 270006 45352 64183262
Bradypnoea 18.94 9.30 56 270062 5103 64223511
Acute graft versus host disease in skin 18.93 9.30 3 270115 6852 64221762
Hepatic encephalopathy 18.92 9.30 152 269966 20914 64207700
Gastric antral vascular ectasia 18.92 9.30 20 270098 788 64227826
Intentional self-injury 18.54 9.30 61 270057 28983 64199631
Ventricular hypokinesia 18.53 9.30 73 270045 7696 64220918
Mesenteric panniculitis 18.45 9.30 12 270106 235 64228379
Genital infection female 18.42 9.30 8 270110 65 64228549
Haematoma 18.40 9.30 284 269834 45966 64182648
Renal tubular disorder 18.31 9.30 61 270057 5926 64222688
Radiation pneumonitis 18.27 9.30 42 270076 3286 64225328
Ocular myasthenia 18.17 9.30 14 270104 362 64228252
Dystonia 18.09 9.30 32 270086 18833 64209781
Stevens-Johnson syndrome 17.98 9.30 221 269897 34028 64194586
Angina bullosa haemorrhagica 17.86 9.30 11 270107 195 64228419
Vitamin B12 deficiency 17.86 9.30 57 270061 5415 64223199
Arthralgia 17.83 9.30 1602 268516 440658 63787956
Phaeochromocytoma malignant 17.72 9.30 8 270110 72 64228542
Nephritic syndrome 17.64 9.30 12 270106 254 64228360
Venoocclusive liver disease 17.61 9.30 10 270108 10005 64218609
Dry mouth 17.58 9.30 353 269765 60065 64168549
Brain scan abnormal 17.50 9.30 23 270095 1145 64227469
Thrombocytopenic purpura 17.46 9.30 32 270086 2130 64226484
Hyperphosphatasaemia 17.44 9.30 8 270110 75 64228539
Tachycardia 17.36 9.30 485 269633 149094 64079520
Type I hypersensitivity 17.35 9.30 43 270075 3531 64225083
Mucosal inflammation 17.24 9.30 173 269945 62411 64166203
Pulmonary arterial hypertension 17.12 9.30 172 269946 25195 64203419
Cardiac aneurysm 17.06 9.30 24 270094 1275 64227339
Eye injury 17.03 9.30 27 270091 1597 64227017
Hyperkinetic heart syndrome 16.92 9.30 9 270109 119 64228495
Ischaemic stroke 16.85 9.30 191 269927 28844 64199770
Occupational exposure to air contaminants 16.79 9.30 9 270109 121 64228493
Chronic graft versus host disease 16.77 9.30 3 270115 6273 64222341
Pre-eclampsia 16.61 9.30 3 270115 6228 64222386
Gastroenteritis eosinophilic 16.58 9.30 11 270107 223 64228391
Nephropathy toxic 16.53 9.30 30 270088 17484 64211130
Rash scarlatiniform 16.49 9.30 11 270107 225 64228389
Angina unstable 16.37 9.30 116 270002 15351 64213263
Cardiorenal syndrome 16.28 9.30 23 270095 1227 64227387
Suicide attempt 16.13 9.30 205 269913 70802 64157812
Prescription form tampering 16.08 9.30 13 270105 361 64228253
Drug eruption 15.98 9.30 226 269892 35910 64192704
Transient ischaemic attack 15.96 9.30 267 269851 43915 64184699
Fall 15.94 9.30 1986 268132 414840 63813774
Premature labour 15.89 9.30 6 270112 7614 64221000
Immunodeficiency 15.78 9.30 27 270091 16097 64212517
Dialysis 15.70 9.30 123 269995 16797 64211817
Deformity 15.70 9.30 60 270058 6237 64222377
CSF volume increased 15.64 9.30 6 270112 34 64228580
Hypotension 15.64 9.30 1378 268740 379596 63849018
Nausea 15.47 9.30 3613 266505 782187 63446427
Drug tolerance decreased 15.47 9.30 5 270113 6993 64221621
Overdose 15.44 9.30 530 269588 159036 64069578
Fear of injection 15.43 9.30 3 270115 5909 64222705
Memory impairment 15.41 9.30 259 269859 85423 64143191
Carotid artery stenosis 15.36 9.30 70 270048 7871 64220743
Substance abuse 15.33 9.30 10 270108 9282 64219332
Eosinophilic fasciitis 15.28 9.30 10 270108 198 64228416
Infection 15.24 9.30 626 269492 184254 64044360
Purging 15.22 9.30 6 270112 37 64228577
Gastrointestinal motility disorder 15.16 9.30 52 270066 5127 64223487
Hyperlipidaemia 15.13 9.30 155 269963 22821 64205793
Nerve degeneration 15.12 9.30 11 270107 260 64228354
Schizophreniform disorder 15.10 9.30 9 270109 150 64228464
Haematoma muscle 15.06 9.30 27 270091 1766 64226848
Duodenitis 15.01 9.30 62 270056 6679 64221935
Systolic dysfunction 14.99 9.30 38 270080 3164 64225450
Escherichia pyelonephritis 14.98 9.30 14 270104 474 64228140
No adverse event 14.98 9.30 65 270053 28496 64200118
Synovial cyst 14.95 9.30 68 270050 7639 64220975
Diverticulum oesophageal 14.95 9.30 9 270109 153 64228461
Microcytic anaemia 14.85 9.30 48 270070 4590 64224024
Heart rate decreased 14.85 9.30 153 269965 54914 64173700
Clinically isolated syndrome 14.84 9.30 5 270113 18 64228596
Injection site haemorrhage 14.81 9.30 52 270066 24226 64204388
Eyelid oedema 14.74 9.30 95 270023 12184 64216430
Pruritus 14.74 9.30 1509 268609 310891 63917723
Coronary artery stenosis 14.73 9.30 89 270029 11159 64217455
Hepatic function abnormal 14.69 9.30 363 269755 63950 64164664
Rhinitis 14.63 9.30 86 270032 10679 64217935
Hypocapnia 14.52 9.30 15 270103 575 64228039
High frequency ablation 14.52 9.30 11 270107 277 64228337
Oesophageal adenocarcinoma 14.50 9.30 17 270101 752 64227862
Anticoagulation drug level increased 14.48 9.30 16 270102 663 64227951
Renal tubular necrosis 14.48 9.30 149 269969 21961 64206653
Transplant dysfunction 14.46 9.30 5 270113 6703 64221911
Cerebellar haematoma 14.42 9.30 15 270103 580 64228034
Thymus disorder 14.40 9.30 10 270108 219 64228395
Sedation 14.36 9.30 108 270010 41354 64187260
Exposure to toxic agent 14.34 9.30 4 270114 6155 64222459
Impaired work ability 14.32 9.30 111 270007 15108 64213506
Hyperkaliuria 14.31 9.30 9 270109 166 64228448
IIIrd nerve paresis 14.21 9.30 9 270109 168 64228446
Contusion 14.14 9.30 366 269752 113599 64115015
Therapy cessation 14.12 9.30 79 270039 32410 64196204
Granuloma skin 14.04 9.30 4 270114 6070 64222544
Haemorrhage intracranial 14.01 9.30 52 270066 23832 64204782
Renal disorder 14.00 9.30 217 269901 35148 64193466
Septic shock 13.95 9.30 557 269561 104880 64123734
Occupational exposure to product 13.95 9.30 15 270103 603 64228011
Small cell carcinoma 13.87 9.30 11 270107 297 64228317
Localised infection 13.85 9.30 72 270046 30089 64198525
Cutaneous lupus erythematosus 13.80 9.30 33 270085 2649 64225965
Gallbladder hypofunction 13.70 9.30 13 270105 449 64228165
Sinus congestion 13.65 9.30 111 270007 15328 64213286
Electric shock 13.57 9.30 20 270098 1109 64227505
Pneumobilia 13.54 9.30 9 270109 183 64228431
Eructation 13.52 9.30 75 270043 9116 64219498
Vitreous detachment 13.51 9.30 27 270091 1917 64226697
Cholecystectomy 13.50 9.30 68 270050 7964 64220650
Psychotic disorder 13.49 9.30 87 270031 34491 64194123
Tooth demineralisation 13.44 9.30 3 270115 0 64228614
Flatulence 13.42 9.30 217 269901 35449 64193165
Thrombophlebitis 13.38 9.30 53 270065 5601 64223013
Graft versus host disease in skin 13.36 9.30 3 270115 5344 64223270
Nephritis allergic 13.36 9.30 15 270103 633 64227981
Hepatocellular carcinoma 13.33 9.30 70 270048 8333 64220281
Cardiotoxicity 13.31 9.30 14 270104 10260 64218354
Oedema peripheral 13.31 9.30 1038 269080 209279 64019335
Crepitations 13.30 9.30 67 270051 7848 64220766
Tongue oedema 13.26 9.30 55 270063 5935 64222679
Pancreatitis chronic 13.24 9.30 39 270079 3547 64225067
Disability 13.23 9.30 19 270099 12153 64216461
Wrong technique in product usage process 13.17 9.30 192 269926 64782 64163832
Pancreatic neuroendocrine tumour 13.10 9.30 13 270105 475 64228139
Infusion site scar 13.09 9.30 10 270108 255 64228359
Subdural haematoma 13.03 9.30 177 269941 27877 64200737
Aspergillus infection 12.98 9.30 31 270087 16348 64212266
Transplant rejection 12.96 9.30 34 270084 17367 64211247
Bile duct stone 12.88 9.30 48 270070 4930 64223684
Oesophagitis 12.88 9.30 143 269975 21487 64207127
Supraventricular extrasystoles 12.85 9.30 54 270064 5861 64222753
Dermatitis exfoliative generalised 12.85 9.30 54 270064 5862 64222752
Ejection fraction abnormal 12.81 9.30 22 270096 1391 64227223
Panniculitis 12.79 9.30 11 270107 8868 64219746
Melaena 12.76 9.30 304 269814 53244 64175370
Bronchopneumopathy 12.70 9.30 14 270104 579 64228035
Fixed eruption 12.69 9.30 28 270090 2131 64226483
Uveal melanoma 12.68 9.30 4 270114 11 64228603
Drug specific antibody present 12.67 9.30 3 270115 5151 64223463
Acute hepatitis B 12.66 9.30 12 270106 414 64228200
Liver function test increased 12.56 9.30 77 270041 30893 64197721
Kidney infection 12.55 9.30 122 269996 17716 64210898
Pleuritic pain 12.54 9.30 67 270051 8029 64220585
Tubulointerstitial nephritis and uveitis syndrome 12.48 9.30 10 270108 274 64228340
Renal impairment 12.44 9.30 688 269430 134329 64094285
Prurigo 12.44 9.30 20 270098 1197 64227417
Normal newborn 12.44 9.30 4 270114 5613 64223001
Ventricular enlargement 12.34 9.30 13 270105 510 64228104
Blood thyroid stimulating hormone increased 12.31 9.30 64 270054 7590 64221024
Diverticulum 12.27 9.30 96 270022 13102 64215512
Lethargy 12.23 9.30 222 269896 72372 64156242
Food interaction 12.22 9.30 22 270096 1444 64227170
Cardio-respiratory arrest 12.20 9.30 316 269802 98077 64130537
Nerve injury 12.18 9.30 64 270054 7621 64220993
Dermatophytosis of nail 12.15 9.30 8 270110 160 64228454
Circumoral oedema 12.15 9.30 10 270108 285 64228329
Seizure 12.13 9.30 573 269545 166319 64062295
Inappropriate schedule of product administration 12.09 9.30 294 269824 91992 64136622
Device use error 12.05 9.30 6 270112 6465 64222149
Myoglobinaemia 12.05 9.30 7 270111 111 64228503
Cyst 12.04 9.30 89 270029 11938 64216676
Antinuclear antibody positive 12.02 9.30 55 270063 6195 64222419
Cerebral infarction 12.01 9.30 240 269878 40804 64187810
Immune-mediated hepatic disorder 12.00 9.30 13 270105 527 64228087
Hypoplastic anaemia 11.96 9.30 4 270114 14 64228600
Cataract 11.90 9.30 290 269828 50972 64177642
Graft versus host disease 11.88 9.30 25 270093 13788 64214826
Cardiac murmur functional 11.80 9.30 5 270113 38 64228576
Respiratory syncytial virus infection 11.75 9.30 8 270110 7260 64221354
Placental calcification 11.75 9.30 4 270114 15 64228599
Essential hypertension 11.75 9.30 48 270070 5146 64223468
Hyperuricaemia 11.72 9.30 78 270040 10113 64218501
Renal infarct 11.69 9.30 29 270089 2382 64226232
Gastric ulcer haemorrhage 11.68 9.30 66 270052 8077 64220537
Cerebral artery thrombosis 11.65 9.30 18 270100 1041 64227573
Intestinal infarction 11.57 9.30 20 270098 1271 64227343
Parkinsonism 11.55 9.30 27 270091 14346 64214268
Vulvovaginal burning sensation 11.54 9.30 19 270099 1160 64227454
Blood lactic acid increased 11.54 9.30 16 270102 10385 64218229
Unintentional medical device removal 11.45 9.30 7 270111 6727 64221887
Bursitis 11.44 9.30 139 269979 21346 64207268
Renal atrophy 11.43 9.30 23 270095 1641 64226973
Anaemia folate deficiency 11.41 9.30 9 270109 241 64228373
Haemorrhoids 11.38 9.30 152 269966 23849 64204765
Therapeutic product effect incomplete 11.38 9.30 338 269780 103144 64125470
Platelet adhesiveness decreased 11.37 9.30 3 270115 3 64228611
Neutrophilia 11.32 9.30 7 270111 6687 64221927
Xerosis 11.31 9.30 17 270101 960 64227654
Creatinine renal clearance abnormal 11.27 9.30 12 270106 477 64228137
Tumour associated fever 11.25 9.30 13 270105 566 64228048
Epstein-Barr virus infection 11.25 9.30 22 270096 12466 64216148
Cytomegalovirus infection reactivation 11.24 9.30 5 270113 5751 64222863
Prothrombin time ratio decreased 11.24 9.30 15 270103 758 64227856
Dehydration 11.23 9.30 1054 269064 215709 64012905
Traumatic haematoma 11.23 9.30 25 270093 1915 64226699
Asthma 11.22 9.30 497 269621 94728 64133886
Coronary artery disease 11.20 9.30 332 269786 60101 64168513
Carotid arteriosclerosis 11.15 9.30 26 270092 2053 64226561
Toxic epidermal necrolysis 11.10 9.30 218 269900 36948 64191666
Cognitive disorder 11.09 9.30 163 269955 54924 64173690
Hypoparathyroidism 11.08 9.30 16 270102 871 64227743
Chest expansion decreased 11.07 9.30 8 270110 187 64228427
Vulval disorder 11.06 9.30 12 270106 487 64228127
Injection site warmth 11.05 9.30 25 270093 13437 64215177
Hyponatraemic seizure 11.02 9.30 12 270106 489 64228125
Cytomegalovirus infection 11.02 9.30 101 270017 37098 64191516
Unevaluable event 11.01 9.30 147 269971 50342 64178272
Device issue 11.01 9.30 53 270065 22595 64206019
Campylobacter gastroenteritis 10.95 9.30 18 270100 1098 64227516
Dermatosis 10.93 9.30 12 270106 494 64228120
Regurgitation 10.90 9.30 26 270092 2083 64226531
Renal hypertension 10.89 9.30 8 270110 192 64228422
Enterocolitis haemorrhagic 10.88 9.30 25 270093 1955 64226659
Creatinine renal clearance decreased 10.87 9.30 28 270090 14393 64214221
Oesophageal hypomotility 10.86 9.30 6 270112 86 64228528
Enterochromaffin cell hyperplasia 10.86 9.30 6 270112 86 64228528
Duodenal polyp 10.83 9.30 9 270109 260 64228354
Purple glove syndrome 10.80 9.30 9 270109 261 64228353
Brief psychotic disorder with marked stressors 10.77 9.30 9 270109 262 64228352
Cholecystitis acute 10.77 9.30 83 270035 11277 64217337
Liver disorder 10.69 9.30 296 269822 53055 64175559
Abdominal strangulated hernia 10.62 9.30 6 270112 90 64228524
Cardiothoracic ratio increased 10.62 9.30 5 270113 50 64228564
Pleurisy 10.61 9.30 71 270047 9220 64219394
Alanine aminotransferase abnormal 10.59 9.30 8 270110 6880 64221734
Colitis ischaemic 10.57 9.30 94 270024 13320 64215294
Gait inability 10.51 9.30 120 269998 42248 64186366
Biliary tract disorder 10.48 9.30 20 270098 1373 64227241
Lipase increased 10.38 9.30 99 270019 14303 64214311
Complication of device insertion 10.36 9.30 4 270114 5008 64223606
Muscle swelling 10.36 9.30 14 270104 716 64227898
Subacute cutaneous lupus erythematosus 10.32 9.30 32 270086 2993 64225621
Withdrawal syndrome 10.28 9.30 57 270061 23435 64205179
Hallucination, olfactory 10.19 9.30 11 270107 444 64228170
Vertigo 10.09 9.30 321 269797 58690 64169924
Abnormal behaviour 10.09 9.30 91 270027 33531 64195083
Arterial spasm 10.02 9.30 7 270111 155 64228459
Eosinophilic oesophagitis 10.01 9.30 11 270107 453 64228161
Adrenocorticotropic hormone deficiency 10.00 9.30 15 270103 845 64227769
Idiosyncratic drug reaction 10.00 9.30 18 270100 1181 64227433
Carbohydrate antigen 19-9 increased 9.99 9.30 10 270108 369 64228245
Coagulation factor decreased 9.98 9.30 7 270111 156 64228458
Teeth brittle 9.97 9.30 11 270107 455 64228159
Vulval oedema 9.97 9.30 4 270114 26 64228588
Nephrosclerosis 9.95 9.30 21 270097 1550 64227064
Herpes simplex test positive 9.95 9.30 10 270108 371 64228243
Blood pressure fluctuation 9.92 9.30 155 269963 51716 64176898
Dyshidrotic eczema 9.90 9.30 12 270106 550 64228064
Therapeutic embolisation 9.88 9.30 11 270107 460 64228154
Enterocolitis 9.88 9.30 85 270033 11933 64216681
Brucellosis 9.86 9.30 6 270112 104 64228510
Laparoscopy 9.86 9.30 3 270115 7 64228607
Impaired healing 9.86 9.30 186 269932 60287 64168327
Gastric cancer stage 0 9.84 9.30 4 270114 27 64228587
Cytomegalovirus viraemia 9.82 9.30 19 270099 10809 64217805
Neurosis 9.71 9.30 10 270108 382 64228232
Vulvovaginal inflammation 9.71 9.30 11 270107 469 64228145
Bronchopulmonary aspergillosis 9.67 9.30 44 270074 19041 64209573
Cardiac disorder 9.64 9.30 304 269814 55512 64173102
Hepatobiliary scan abnormal 9.61 9.30 5 270113 63 64228551
Tongue pruritus 9.56 9.30 11 270107 477 64228137
Cellulitis 9.54 9.30 309 269809 93348 64135266
Conjunctival ulcer 9.54 9.30 5 270113 64 64228550
Shock haemorrhagic 9.54 9.30 110 270008 16681 64211933
Nocardiosis 9.53 9.30 4 270114 4763 64223851
Burning sensation 9.52 9.30 274 269844 49390 64179224
Obesity 9.49 9.30 49 270069 20513 64208101
Brain injury 9.47 9.30 17 270101 9948 64218666
Tooth disorder 9.47 9.30 139 269979 22263 64206351
Basal cell carcinoma 9.46 9.30 83 270035 30755 64197859
Faecal vomiting 9.34 9.30 16 270102 1009 64227605
False negative investigation result 9.34 9.30 8 270110 241 64228373
Eosinophilic pneumonia 9.34 9.30 41 270077 4536 64224078
Mesenteric artery stenosis 9.32 9.30 3 270115 9 64228605

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC05 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD06 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Combinations for eradication of Helicobacter pylori
ATC M01AE52 MUSCULO-SKELETAL SYSTEM
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
Propionic acid derivatives
FDA MoA N0000000147 Proton Pump Inhibitors
FDA EPC N0000175525 Proton Pump Inhibitor
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D054328 Proton Pump Inhibitors
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:49200 proton pump inhibitors
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:50183 P450 inhibitors
CHEBI has role CHEBI:77746 Homo sapiens metabolite
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:38623 monoamine oxidase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Erosive esophagitis indication 40719004
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Peptic reflux disease indication 57643001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Prevention of NSAID-Induced Gastric Ulcer indication
Osteoarthritis in Patients at High Ulcer Risk indication
Rheumatoid Arthritis in Patient at High Ulcer Risk indication
Pathological Gastric Hypersecretory Condition indication
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Erosive Esophagitis indication
Upper gastrointestinal hemorrhage off-label use 37372002
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Atrophic gastritis contraindication 84568007 DOID:8929
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.71 acidic
pKa2 4.44 Basic
pKa3 2.53 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;375MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8852636 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 8858996 May 31, 2022 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9161920 May 31, 2022 RISK-REDUCTION OF NSAID GASTRIC ULCER IN PATIENTS REQUIRING CHRONIC NSAID TREATMENT
EQ 20MG BASE;500MG VIMOVO HORIZON N022511 April 30, 2010 RX TABLET, DELAYED RELEASE ORAL 9198888 May 31, 2022 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER IN PATIENTS REQUIRING NSAID TREATMENT
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
Potassium-transporting ATPase Transporter INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4021259 VUID
N0000189434 NUI
D01984 KEGG_DRUG
217087-10-0 SECONDARY_CAS_RN
217087-09-7 SECONDARY_CAS_RN
161796-78-7 SECONDARY_CAS_RN
934714-36-0 SECONDARY_CAS_RN
4019439 VANDF
4021259 VANDF
4021260 VANDF
4025229 VANDF
4032661 VANDF
C0937846 UMLSCUI
CHEBI:50275 CHEBI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1201320 ChEMBL_ID
DB00736 DRUGBANK_ID
CHEMBL2146133 ChEMBL_ID
CHEMBL1200470 ChEMBL_ID
D064098 MESH_DESCRIPTOR_UI
4594 PUBCHEM_CID
5488 IUPHAR_LIGAND_ID
7766 INN_ID
N3PA6559FT UNII
DB00338 DRUGBANK_ID
1294569 RXNORM
15914 MMSL
19233 MMSL
205449 MMSL
211151 MMSL
232889 MMSL
29630 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
d04749 MMSL
003476 NDDF
008590 NDDF
008918 NDDF
008919 NDDF
015173 NDDF
129489006 SNOMEDCT_US
25673006 SNOMEDCT_US
317331009 SNOMEDCT_US
387137007 SNOMEDCT_US
396047003 SNOMEDCT_US
426956003 SNOMEDCT_US
725855001 SNOMEDCT_US
C0028978 UMLSCUI
CHEMBL2146140 ChEMBL_ID
D009853 MESH_DESCRIPTOR_UI
5081 INN_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6450 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0093-6451 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
good sense esomeprazole magnesium HUMAN OTC DRUG LABEL 1 0113-0651 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
basic care esomeprazole magnesium HUMAN OTC DRUG LABEL 1 0113-0732 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Good Sense Esomeprazole Magnesium HUMAN OTC DRUG LABEL 1 0113-0898 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Esomeprazole magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0186-0382 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA authorized generic 28 sections
Esomeprazole magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0186-0384 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA authorized generic 28 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4010 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4010 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4020 GRANULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4020 GRANULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4025 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4025 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4040 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4040 GRANULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4050 GRANULE, DELAYED RELEASE 5 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-4050 GRANULE, DELAYED RELEASE 5 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5020 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5020 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5040 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUM HUMAN PRESCRIPTION DRUG LABEL 1 0186-5040 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 27 sections
NEXIUMI.V. HUMAN PRESCRIPTION DRUG LABEL 1 0186-6040 INJECTION 40 mg INTRAVENOUS NDA 28 sections
NEXIUMI.V. HUMAN PRESCRIPTION DRUG LABEL 1 0186-6040 INJECTION 40 mg INTRAVENOUS NDA 28 sections
Esomeprazole Magnesium Human OTC Drug Label 1 0363-0508 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 12 sections
Esomeprazole Magnesium HUMAN OTC DRUG LABEL 1 0363-1699 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
esomeprazole magnesium HUMAN OTC DRUG LABEL 1 0363-1898 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Esomeprazole Magnesium HUMAN OTC DRUG LABEL 1 0363-3298 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 14 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2350 CAPSULE, DELAYED RELEASE PELLETS 20 mg ORAL ANDA 30 sections
Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 1 0378-2351 CAPSULE, DELAYED RELEASE PELLETS 40 mg ORAL ANDA 30 sections
Naproxen and Esomeprazole Magnesium HUMAN PRESCRIPTION DRUG LABEL 2 0378-4385 TABLET, FILM COATED 20 mg ORAL ANDA 33 sections