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

Stem definitionDrug idCAS RN
antiulcer, benzimidazole derivatives 1990 73590-58-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • omeprazole sodium
  • omeprazole
  • omeprazole magnesium
  • omeprazole sodium bicarbonate
A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
  • 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
20 mg O
20 mg P

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 % 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
Vd (Volume of distribution) 0.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 8.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.58 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Sept. 14, 1989 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
Drug ineffective 1145.65 9.92 3472 429779 915517 54943299
Pemphigus 1139.70 9.92 13 433238 157199 55701617
Rheumatoid arthritis 1098.39 9.92 807 432444 381797 55477019
Contraindicated product administered 988.86 9.92 132 433119 186154 55672662
Synovitis 977.56 9.92 68 433183 161237 55697579
Drug intolerance 908.31 9.92 452 432799 264366 55594450
Hand deformity 879.35 9.92 36 433215 134456 55724360
Systemic lupus erythematosus 796.56 9.92 202 433049 179876 55678940
Glossodynia 754.24 9.92 132 433119 152326 55706490
Treatment failure 742.41 9.92 197 433054 170195 55688621
Anti-cyclic citrullinated peptide antibody positive 719.73 9.92 7 433244 98593 55760223
Chronic kidney disease 664.40 9.92 1175 432076 40881 55817935
Wound 640.74 9.92 142 433109 138662 55720154
Hypomagnesaemia 630.71 9.92 867 432384 24148 55834668
Maternal exposure during pregnancy 575.81 9.92 375 432876 189178 55669638
Pericarditis 573.40 9.92 79 433172 108844 55749972
Therapeutic product effect decreased 561.55 9.92 302 432949 169150 55689666
Rheumatoid factor positive 498.93 9.92 6 433245 69054 55789762
Tubulointerstitial nephritis 493.35 9.92 625 432626 16040 55842776
Infusion related reaction 483.40 9.92 537 432714 208394 55650422
Arthropathy 480.87 9.92 499 432752 199776 55659040
Joint swelling 474.10 9.92 947 432304 288853 55569963
Duodenal ulcer perforation 444.19 9.92 19 433232 68323 55790493
Off label use 423.72 9.92 2530 430721 553650 55305166
Acute kidney injury 420.57 9.92 3231 430020 237532 55621284
Drug interaction 418.54 9.92 2906 430345 206849 55651967
Hyponatraemia 402.91 9.92 1706 431545 100433 55758383
Discomfort 400.58 9.92 303 432948 141458 55717358
Alopecia 395.37 9.92 1064 432187 292394 55566422
Hepatic enzyme increased 379.56 9.92 456 432795 170928 55687888
Helicobacter infection 354.47 9.92 67 433184 73201 55785615
Muscle injury 350.04 9.92 12 433239 52488 55806328
Product use issue 349.85 9.92 557 432694 185484 55673332
Abdominal discomfort 326.67 9.92 1070 432181 276204 55582612
Folliculitis 324.80 9.92 26 433225 54953 55803863
Drug hypersensitivity 320.78 9.92 1067 432184 274138 55584678
Sleep disorder due to general medical condition, insomnia type 295.83 9.92 8 433243 43330 55815486
Swelling 281.83 9.92 926 432325 238845 55619971
Subacute cutaneous lupus erythematosus 277.40 9.92 191 433060 2158 55856658
Hypersensitivity 265.07 9.92 1045 432206 255363 55603453
Hypocalcaemia 232.94 9.92 613 432638 28147 55830669
Renal injury 223.93 9.92 308 432943 8579 55850237
Rheumatic fever 206.01 9.92 3 433248 28824 55829992
Exposure during pregnancy 196.66 9.92 477 432774 135865 55722951
C-reactive protein abnormal 195.28 9.92 26 433225 36783 55822033
Completed suicide 193.21 9.92 468 432783 133365 55725451
End stage renal disease 191.74 9.92 236 433015 5875 55852941
Diarrhoea 188.59 9.92 6328 426923 632179 55226637
Therapeutic product effect incomplete 183.95 9.92 334 432917 105697 55753119
Orthostatic hypotension 179.97 9.92 614 432637 32585 55826231
Irritable bowel syndrome 175.16 9.92 161 433090 68297 55790519
Constipation 169.94 9.92 2334 430917 199609 55659207
Gastrooesophageal reflux disease 165.98 9.92 1154 432097 82103 55776713
Fall 163.36 9.92 3749 429502 353761 55505055
Impaired healing 157.48 9.92 266 432985 86575 55772241
Balance disorder 155.71 9.92 1066 432185 75454 55783362
Creatinine renal clearance decreased 153.97 9.92 344 432907 14215 55844601
Ill-defined disorder 150.93 9.92 183 433068 68360 55790456
Sedation complication 150.43 9.92 299 432952 11373 55847443
Blood calcium decreased 148.11 9.92 461 432790 23308 55835508
Rash 141.35 9.92 2811 430440 490236 55368580
Abdominal pain 140.38 9.92 2783 430468 256022 55602794
Musculoskeletal stiffness 134.96 9.92 679 432572 155328 55703488
Cognitive disorder 127.79 9.92 729 432522 48404 55810412
Hypokalaemia 125.75 9.92 1194 432057 93243 55765573
Infection 123.73 9.92 967 432284 199239 55659577
Cholecystitis chronic 120 9.92 245 433006 9503 55849313
Intentional product use issue 119.89 9.92 381 432870 99352 55759464
Drug abuse 115.43 9.92 215 433036 67395 55791421
Pain 110.73 9.92 4084 429167 659100 55199716
Psoriatic arthropathy 110.59 9.92 254 432997 73754 55785062
Red blood cell sedimentation rate abnormal 109.80 9.92 9 433242 18664 55840152
Stomatitis 107.81 9.92 520 432731 120290 55738526
Blister 107.16 9.92 452 432799 108435 55750381
Condition aggravated 107.09 9.92 1939 431312 342959 55515857
Nasopharyngitis 104.22 9.92 1142 432109 219817 55638999
Abortion spontaneous 100.41 9.92 113 433138 43640 55815176
Tetany 95.08 9.92 89 433162 1603 55857213
Sedation 89.88 9.92 516 432735 34338 55824478
Muscle spasms 86.42 9.92 1512 431739 135859 55722957
Drug tolerance decreased 86.23 9.92 4 433247 13407 55845409
Dizziness 84.20 9.92 3618 429633 372522 55486294
Vomiting 84.06 9.92 4661 428590 493567 55365249
Renal failure 83.21 9.92 1253 431998 109247 55749569
Arthralgia 81.39 9.92 3099 430152 498570 55360246
Gastritis 80.04 9.92 499 432752 34203 55824613
Hypertensive nephropathy 79.04 9.92 50 433201 484 55858332
Device expulsion 78.60 9.92 71 433180 30378 55828438
Hip arthroplasty 77.95 9.92 110 433141 38513 55820303
Liver injury 77.87 9.92 126 433125 41722 55817094
Type 2 diabetes mellitus 76.52 9.92 153 433098 46709 55812107
Gastrointestinal disorder 76.45 9.92 530 432721 112172 55746644
Dehydration 74.31 9.92 1672 431579 157153 55701663
Product use in unapproved indication 72.82 9.92 712 432539 140110 55718706
Gastrointestinal haemorrhage 72.63 9.92 899 432352 75052 55783764
General physical health deterioration 71.49 9.92 901 432350 169109 55689707
Asthenia 71.00 9.92 3273 429978 339700 55519116
Drug resistance 70.34 9.92 35 433216 20507 55838309
Pancreatitis acute 69.45 9.92 379 432872 24745 55834071
Red blood cell sedimentation rate increased 69.34 9.92 109 433142 36514 55822302
Therapy non-responder 67.83 9.92 243 433008 61112 55797704
Bone erosion 67.67 9.92 16 433235 14958 55843858
Nausea 67.34 9.92 6787 426464 757391 55101425
Gastric pH decreased 67.17 9.92 50 433201 644 55858172
Hypoparathyroidism 66.21 9.92 48 433203 592 55858224
Rheumatoid nodule 64.96 9.92 17 433234 14840 55843976
Blood pressure systolic increased 63.57 9.92 137 433114 40699 55818117
Swollen tongue 63.17 9.92 425 432826 29899 55828917
Cogwheel rigidity 62.98 9.92 75 433176 1802 55857014
Vision blurred 62.61 9.92 941 432310 82002 55776814
Infective pulmonary exacerbation of cystic fibrosis 61.15 9.92 169 433082 7988 55850828
Malaise 60.85 9.92 3436 429815 364424 55494392
Haematemesis 60.48 9.92 404 432847 28354 55830462
Chest pain 59.70 9.92 1897 431354 187900 55670916
Urinary tract infection 58.87 9.92 2336 430915 238177 55620639
Peripheral swelling 57.54 9.92 1371 431880 233355 55625461
Anaemia 57.51 9.92 2563 430688 264948 55593868
Pregnancy 57.30 9.92 104 433147 32929 55825887
Abdominal pain upper 57.07 9.92 1786 431465 176527 55682289
Lethargy 56.32 9.92 625 432626 50816 55808000
Hiatus hernia 56.05 9.92 299 432952 19353 55839463
Hypotension 55.59 9.92 2408 430843 248100 55610716
Gastric polyps 55.25 9.92 93 433158 3105 55855711
Tenosynovitis 54.97 9.92 14 433237 12447 55846369
Live birth 53.92 9.92 43 433208 19562 55839254
Disorientation 53.30 9.92 472 432779 36141 55822675
Syncope 53.10 9.92 1147 432104 107052 55751764
Flatulence 52.81 9.92 417 432834 30871 55827945
Metabolic alkalosis 52.06 9.92 85 433166 2766 55856050
Tremor 51.47 9.92 1258 431993 119831 55738985
Lower respiratory tract infection 51.42 9.92 600 432651 114194 55744622
Therapeutic response decreased 51.26 9.92 220 433031 52538 55806278
Blood cholesterol increased 50.85 9.92 338 432913 72241 55786575
Liver function test abnormal 50.50 9.92 556 432695 45115 55813701
Paraesthesia 50.50 9.92 1339 431912 129175 55729641
Knee arthroplasty 50.46 9.92 173 433078 44086 55814730
Adverse event 49.57 9.92 238 433013 55138 55803678
Sinusitis 49.53 9.92 1150 432101 196431 55662385
Toxicity to various agents 49.31 9.92 1333 431918 223231 55635585
International normalised ratio increased 49.09 9.92 537 432714 43504 55815312
Coma 49.08 9.92 264 432987 59391 55799425
Muscle spasticity 48.64 9.92 49 433202 19911 55838905
Deep vein thrombosis 47.56 9.92 845 432406 76132 55782684
Pulmonary embolism 47.37 9.92 1119 432132 106005 55752811
Dyspnoea 47.25 9.92 5229 428022 587348 55271468
Intentional overdose 46.83 9.92 319 432932 67798 55791018
Gallbladder disorder 46.25 9.92 259 432992 17075 55841741
Chronic obstructive pulmonary disease 45.52 9.92 657 432594 56758 55802058
Dyspepsia 45.26 9.92 898 432353 82573 55776243
Hypertrichosis 44.19 9.92 48 433203 1040 55857776
Biliary dyskinesia 43.57 9.92 74 433177 2489 55856327
Nephropathy 42.83 9.92 117 433134 5492 55853324
Lip swelling 42.09 9.92 346 432905 25926 55832890
Abdominal distension 41.71 9.92 834 432417 76792 55782024
Diabetic nephropathy 41.70 9.92 52 433199 1312 55857504
Accidental exposure to product 41.51 9.92 79 433172 24568 55834248
Product formulation issue 40.91 9.92 34 433217 519 55858297
Loss of personal independence in daily activities 40.54 9.92 415 432836 80954 55777862
Burning mouth syndrome 40.53 9.92 31 433220 417 55858399
Upper gastrointestinal haemorrhage 40.44 9.92 247 433004 16807 55842009
Feeling of despair 40.41 9.92 65 433186 2088 55856728
Parkinsonism 40.37 9.92 163 433088 9383 55849433
Sepsis 40.17 9.92 1383 431868 138457 55720359
Swelling face 39.96 9.92 630 432621 55439 55803377
Atrial fibrillation 39.78 9.92 1109 432142 107788 55751028
Weight increased 39.33 9.92 1409 431842 228294 55630522
Suicide attempt 38.70 9.92 273 432978 57563 55801253
Depersonalisation/derealisation disorder 37.90 9.92 48 433203 1231 55857585
Overdose 37.63 9.92 580 432671 105250 55753566
Derealisation 37.61 9.92 44 433207 1037 55857779
Depression 37.42 9.92 1720 431531 178397 55680419
C-reactive protein increased 37.30 9.92 406 432845 78278 55780538
Grip strength decreased 37.28 9.92 42 433209 16214 55842602
Malignant neoplasm progression 37.20 9.92 374 432877 73213 55785603
Rhabdomyolysis 37.04 9.92 477 432774 40181 55818635
Cholelithiasis 36.80 9.92 465 432786 38999 55819817
Blood sodium decreased 36.78 9.92 296 432955 22038 55836778
Panniculitis 36.46 9.92 15 433236 9827 55848989
Pulmonary malformation 36.07 9.92 23 433228 226 55858590
Premature delivery 35.65 9.92 99 433152 26961 55831855
Hallucinations, mixed 35.51 9.92 94 433157 4330 55854486
H1N1 influenza 35.50 9.92 53 433198 1594 55857222
Haemoglobin decreased 34.94 9.92 1312 431939 132825 55725991
Dysgeusia 34.36 9.92 473 432778 40442 55818374
Toxic epidermal necrolysis 34.09 9.92 288 432963 21754 55837062
Myalgia 33.83 9.92 1289 431962 130736 55728080
Pneumonia 33.70 9.92 3602 429649 403496 55455320
Breast cancer stage III 33.69 9.92 7 433244 7156 55851660
Caesarean section 33.30 9.92 45 433206 16046 55842770
Blood pressure systolic abnormal 32.96 9.92 17 433234 9760 55849056
Oesophagitis 32.95 9.92 203 433048 13854 55844962
Clostridium difficile infection 32.82 9.92 337 432914 26861 55831955
Blood pressure diastolic abnormal 32.45 9.92 25 433226 11573 55847243
Hip fracture 32.45 9.92 334 432917 26639 55832177
Intestinal dilatation 32.36 9.92 48 433203 1435 55857381
Dry mouth 32.25 9.92 683 432568 63522 55795294
Palatal oedema 31.81 9.92 28 433223 464 55858352
Hypoaesthesia oral 31.30 9.92 172 433079 11259 55847557
Gallbladder injury 31.17 9.92 44 433207 1256 55857560
Nephrogenic anaemia 31.09 9.92 54 433197 1850 55856966
Blood magnesium decreased 30.74 9.92 176 433075 11698 55847118
Dilatation intrahepatic duct acquired 30.55 9.92 31 433220 619 55858197
Torus fracture 30.53 9.92 17 433234 127 55858689
Device difficult to use 30.36 9.92 23 433228 10738 55848078
Hypoparathyroidism secondary 30.14 9.92 12 433239 36 55858780
Mania 29.99 9.92 171 433080 11349 55847467
Cross sensitivity reaction 29.94 9.92 55 433196 1970 55856846
Prescribed overdose 29.80 9.92 81 433170 22215 55836601
Abdominal tenderness 29.77 9.92 127 433124 7494 55851322
Product dose omission issue 29.71 9.92 1891 431360 202862 55655954
Serotonin syndrome 29.06 9.92 322 432929 26168 55832648
Pancreatitis 28.96 9.92 498 432753 44582 55814234
Rebound acid hypersecretion 28.88 9.92 22 433229 294 55858522
Angioedema 28.86 9.92 464 432787 40989 55817827
Hypoglycaemia 28.76 9.92 596 432655 55219 55803597
Enthesopathy 28.74 9.92 13 433238 8050 55850766
Hypergammaglobulinaemia 28.71 9.92 26 433225 448 55858368
Lipase increased 28.66 9.92 141 433110 8838 55849978
Fibromyalgia 28.46 9.92 307 432944 59296 55799520
Poisoning deliberate 28.43 9.92 21 433230 9932 55848884
Maternal exposure timing unspecified 28.36 9.92 4 433247 5419 55853397
Inappropriate antidiuretic hormone secretion 28.17 9.92 192 433059 13564 55845252
Cholecystitis 28.10 9.92 199 433052 14236 55844580
Hallucination 28.07 9.92 533 432718 48616 55810200
Cholecystectomy 28.06 9.92 148 433103 9536 55849280
Transient ischaemic attack 27.72 9.92 387 432864 33190 55825626
Feeling of body temperature change 27.66 9.92 88 433163 4501 55854315
Pulmonary toxicity 27.65 9.92 13 433238 7870 55850946
Blood parathyroid hormone decreased 27.53 9.92 15 433236 8349 55850467
Sopor 27.23 9.92 77 433174 20845 55837971
Parosmia 27.18 9.92 89 433162 4622 55854194
Product substitution issue 27.12 9.92 199 433052 14400 55844416
Plasma cell myeloma 27.03 9.92 507 432744 46139 55812677
Joint range of motion decreased 27.02 9.92 102 433149 25263 55833553
Drug dispensed to wrong patient 26.85 9.92 18 433233 194 55858622
Feeling abnormal 26.70 9.92 1271 431980 132331 55726485
Macular degeneration 26.56 9.92 67 433184 18841 55839975
Blood pressure fluctuation 26.27 9.92 192 433059 40168 55818648
Rectal haemorrhage 26.25 9.92 457 432794 41010 55817806
Memory impairment 26.10 9.92 861 432390 85696 55773120
Lip dry 26.00 9.92 22 433229 9718 55849098
Neutropenic sepsis 25.96 9.92 203 433048 14982 55843834
Abnormal loss of weight 25.95 9.92 95 433156 5221 55853595
Electrocardiogram QT prolonged 25.91 9.92 576 432675 54012 55804804
Unintentional medical device removal 25.90 9.92 6 433245 5688 55853128
Faeces discoloured 25.72 9.92 221 433030 16775 55842041
Respiratory tract malformation 25.54 9.92 16 433235 152 55858664
Cystic fibrosis 25.46 9.92 71 433180 3373 55855443
Acute generalised exanthematous pustulosis 25.37 9.92 146 433105 9723 55849093
Congenital thrombocytopenia 25.26 9.92 11 433240 44 55858772
Calcium deficiency 25.25 9.92 35 433216 982 55857834
Hypophosphataemia 25.24 9.92 144 433107 9558 55849258
Dissociation 25.03 9.92 59 433192 2526 55856290
Nephroangiosclerosis 25.00 9.92 15 433236 131 55858685
Limb reduction defect 24.97 9.92 22 433229 365 55858451
Melaena 24.97 9.92 330 432921 27960 55830856
Anxiety 24.64 9.92 1765 431486 191407 55667409
Blood alkaline phosphatase increased 24.57 9.92 429 432822 38516 55820300
Maternal exposure before pregnancy 24.32 9.92 11 433240 6812 55852004
Urinary retention 24.17 9.92 326 432925 27748 55831068
Drooling 23.86 9.92 70 433181 3424 55855392
Facet joint syndrome 23.68 9.92 11 433240 6706 55852110
Palpitations 23.62 9.92 965 432286 98707 55760109
Lung cyst 23.58 9.92 19 433232 277 55858539
Hypergastrinaemia 23.58 9.92 13 433238 95 55858721
Confusional state 23.56 9.92 1884 431367 206271 55652545
Chronic kidney disease-mineral and bone disorder 23.48 9.92 18 433233 243 55858573
Mouth swelling 23.28 9.92 77 433174 4020 55854796
Moraxella test positive 23.01 9.92 8 433243 14 55858802
Depressed level of consciousness 22.98 9.92 583 432668 55850 55802966
Back pain 22.84 9.92 2121 431130 235049 55623767
Insulin autoimmune syndrome 22.79 9.92 12 433239 79 55858737
Skin test positive 22.73 9.92 27 433224 647 55858169
Breast cancer stage II 22.62 9.92 8 433243 5750 55853066
Hyperkalaemia 22.37 9.92 531 432720 50334 55808482
Truncus coeliacus thrombosis 22.33 9.92 7 433244 7 55858809
Prescription drug used without a prescription 22.31 9.92 48 433203 1932 55856884
Skin necrosis 22.27 9.92 38 433213 12323 55846493
Adjusted calcium decreased 22.19 9.92 15 433236 164 55858652
Pregnancy with contraceptive device 22.19 9.92 3 433248 4196 55854620
Foetal death 22.19 9.92 20 433231 8567 55850249
Muscle disorder 22.05 9.92 82 433169 4541 55854275
Stevens-Johnson syndrome 21.97 9.92 269 432982 22394 55836422
Muscle rigidity 21.89 9.92 149 433102 10522 55848294
Chest discomfort 21.82 9.92 950 432301 97907 55760909
Temperature regulation disorder 21.78 9.92 4 433247 4464 55854352
Restless legs syndrome 21.42 9.92 212 433039 16735 55842081
Ankylosing spondylitis 21.34 9.92 27 433224 9903 55848913
Product packaging confusion 21.26 9.92 14 433237 146 55858670
Respiratory arrest 21.25 9.92 143 433108 30482 55828334
Emotional distress 21.04 9.92 334 432917 29429 55829387
Small intestinal obstruction 21.03 9.92 210 433041 16615 55842201
Dysphagia 20.96 9.92 800 432451 81147 55777669
Hyperhidrosis 20.95 9.92 905 432346 93183 55765633
Cutaneous lupus erythematosus 20.84 9.92 55 433196 2529 55856287
Presyncope 20.78 9.92 294 432957 25288 55833528
Device use error 20.73 9.92 8 433243 5448 55853368
Nervousness 20.66 9.92 326 432925 28689 55830127
Aplastic anaemia 20.54 9.92 23 433228 8905 55849911
Tinnitus 20.44 9.92 335 432916 29707 55829109
Long QT syndrome 20.41 9.92 61 433190 3015 55855801
Hyperchlorhydria 20.36 9.92 41 433210 1574 55857242
Blood potassium decreased 20.27 9.92 414 432837 38258 55820558
Type I hypersensitivity 20.24 9.92 53 433198 2425 55856391
Inflammation 20.21 9.92 392 432859 68679 55790137
Fatigue 20.11 9.92 5585 427666 782967 55075849
Full blood count decreased 20.04 9.92 271 432980 23078 55835738
Atrioventricular block first degree 20.02 9.92 104 433147 6661 55852155
Duodenal stenosis 19.95 9.92 22 433229 485 55858331
Body temperature decreased 19.82 9.92 72 433179 18036 55840780
Non-cardiac chest pain 19.67 9.92 94 433157 5822 55852994
Disturbance in attention 19.66 9.92 356 432895 32184 55826632
Giardiasis 19.58 9.92 9 433242 42 55858774
Thermohypoaesthesia 19.42 9.92 12 433239 111 55858705
Skin discolouration 19.42 9.92 372 432879 33984 55824832
Acute respiratory failure 19.41 9.92 341 432910 30653 55828163
Breast cancer stage I 19.33 9.92 12 433239 6218 55852598
Dysuria 19.21 9.92 338 432913 30391 55828425
Agitation 19.16 9.92 566 432685 55470 55803346
Congenital ovarian anomaly 19.14 9.92 6 433245 6 55858810
Nightmare 19.13 9.92 206 433045 16620 55842196
Lower gastrointestinal haemorrhage 18.92 9.92 107 433144 7080 55851736
Cellulitis 18.77 9.92 730 432521 74219 55784597
Oral pain 18.56 9.92 295 432956 25998 55832818
Multiple-drug resistance 18.45 9.92 4 433247 3970 55854846
Catatonia 18.38 9.92 4 433247 3960 55854856
Metastases to lymph nodes 18.34 9.92 18 433233 7405 55851411
Fear of injection 18.28 9.92 14 433237 6501 55852315
Injection site reaction 18.19 9.92 294 432957 52953 55805863
Intravascular haemolysis 18.08 9.92 16 433235 267 55858549
Deformity 18.04 9.92 32 433219 10223 55848593
Cholecystitis acute 17.96 9.92 108 433143 7308 55851508
Malignant mediastinal neoplasm 17.92 9.92 28 433223 877 55857939
Disability 17.77 9.92 62 433189 15718 55843098
Hepatic encephalopathy 17.75 9.92 136 433115 9974 55848842
Target skin lesion 17.69 9.92 11 433240 103 55858713
Intestinal obstruction 17.60 9.92 308 432943 27663 55831153
Tongue blistering 17.55 9.92 36 433215 1401 55857415
Drug eruption 17.53 9.92 121 433130 25642 55833174
Avian influenza 17.51 9.92 9 433242 56 55858760
Normal newborn 17.46 9.92 19 433232 7451 55851365
Obstructive airways disorder 17.45 9.92 71 433180 17211 55841605
Myelosuppression 17.44 9.92 72 433179 17383 55841433
Subdural haemorrhage 17.33 9.92 55 433196 2809 55856007
Therapeutic product ineffective 17.15 9.92 35 433216 1357 55857459
Chromaturia 17.14 9.92 187 433064 15138 55843678
Head discomfort 17.03 9.92 154 433097 11860 55846956
Beta haemolytic streptococcal infection 17.02 9.92 42 433209 1852 55856964
Sight disability 17.01 9.92 11 433240 111 55858705
Jaundice 16.98 9.92 300 432951 26994 55831822
Eyelid retraction 16.97 9.92 8 433243 40 55858776
International normalised ratio abnormal 16.84 9.92 56 433195 2932 55855884
Drug ineffective for unapproved indication 16.83 9.92 122 433129 25571 55833245
Bicytopenia 16.79 9.92 45 433206 2088 55856728
Mood swings 16.77 9.92 200 433051 16547 55842269
Dialysis 16.75 9.92 130 433121 9572 55849244
Hepatitis acute 16.73 9.92 116 433135 8241 55850575
Blood urea increased 16.69 9.92 273 432978 24200 55834616
Stillbirth 16.63 9.92 14 433237 6200 55852616
Pneumonitis 16.57 9.92 338 432913 31226 55827590
Viral diarrhoea 16.55 9.92 12 433239 148 55858668
Vertigo 16.49 9.92 543 432708 54029 55804787
Bromhidrosis 16.47 9.92 5 433246 4 55858812
Incontinence 16.46 9.92 140 433111 10595 55848221
Multiple drug therapy 16.34 9.92 53 433198 2739 55856077
Adverse drug reaction 16.32 9.92 379 432872 64753 55794063
Blood chromogranin A increased 16.31 9.92 15 433236 264 55858552
Joint stiffness 16.30 9.92 184 433067 35241 55823575
Cardiotoxicity 16.23 9.92 21 433230 7629 55851187
Iron deficiency anaemia 16.22 9.92 210 433041 17709 55841107
Akathisia 16.14 9.92 26 433225 8626 55850190
Decreased appetite 16.07 9.92 1925 431326 217306 55641510
Colitis ischaemic 16.07 9.92 132 433119 9888 55848928
Dislocation of vertebra 16.03 9.92 11 433240 5404 55853412
Polyserositis 15.99 9.92 16 433235 314 55858502
Mesenteric artery thrombosis 15.97 9.92 12 433239 157 55858659
Therapeutic response shortened 15.88 9.92 30 433221 9356 55849460
Foetal exposure during pregnancy 15.83 9.92 175 433076 33648 55825168
Body height decreased 15.82 9.92 123 433128 9062 55849754
Multimorbidity 15.79 9.92 20 433231 513 55858303
Hyperreflexia 15.74 9.92 81 433170 5169 55853647
Femur fracture 15.72 9.92 405 432846 38890 55819926
Cytomegalovirus viraemia 15.69 9.92 10 433241 5110 55853706
Oedema peripheral 15.65 9.92 1526 431725 169728 55689088
Breast cancer female 15.62 9.92 46 433205 12292 55846524
Blood pressure diastolic decreased 15.62 9.92 86 433165 19237 55839579
Adjustment disorder with depressed mood 15.60 9.92 10 433241 5093 55853723
X-ray abnormal 15.47 9.92 7 433244 4334 55854482
Hypophagia 15.42 9.92 310 432941 28566 55830250
Respirovirus test positive 15.32 9.92 6 433245 17 55858799
Diverticulum 15.25 9.92 141 433110 10925 55847891
Dysphonia 15.25 9.92 427 432824 41520 55817296
Malnutrition 15.24 9.92 170 433081 13838 55844978
Compartment syndrome 15.24 9.92 42 433209 1982 55856834
Polyuria 15.23 9.92 105 433146 7446 55851370
Pallor 15.23 9.92 266 432985 23883 55834933
Drug dose titration not performed 15.13 9.92 19 433232 483 55858333
Injection site pain 15.04 9.92 742 432509 116376 55742440
Cough 14.99 9.92 2250 431001 257711 55601105
Cerebrovascular accident 14.96 9.92 920 432331 98350 55760466
Gallbladder cholesterolosis 14.87 9.92 23 433228 714 55858102
Colitis 14.75 9.92 424 432827 41387 55817429
Gastrointestinal erosion 14.68 9.92 21 433230 607 55858209
Superior mesenteric artery syndrome 14.68 9.92 9 433242 82 55858734
Labelled drug-drug interaction medication error 14.67 9.92 145 433106 11441 55847375
Poisoning 14.66 9.92 50 433201 12763 55846053
Acute psychosis 14.55 9.92 45 433206 2267 55856549
Genital blister 14.50 9.92 9 433242 84 55858732
Post transplant lymphoproliferative disorder 14.49 9.92 9 433242 4663 55854153
Rash macular 14.48 9.92 231 433020 20373 55838443
Necrosis ischaemic 14.39 9.92 24 433227 795 55858021
Limb hypoplasia congenital 14.34 9.92 12 433239 185 55858631
Pathogen resistance 14.31 9.92 15 433236 5985 55852831
Biliary colic 14.31 9.92 58 433193 3344 55855472
Bone pain 14.31 9.92 496 432755 49689 55809127
Renal artery arteriosclerosis 14.30 9.92 5 433246 9 55858807
Endoscopy abnormal 14.30 9.92 5 433246 9 55858807
Gastrointestinal stoma complication 14.23 9.92 35 433216 1540 55857276
Norovirus test positive 14.20 9.92 11 433240 151 55858665
Miosis 14.08 9.92 18 433233 6574 55852242
Abnormal weight gain 14.05 9.92 34 433217 1481 55857335
Occult blood positive 14.00 9.92 57 433194 3294 55855522
Hand-eye coordination impaired 13.97 9.92 6 433245 23 55858793
Single functional kidney 13.79 9.92 11 433240 158 55858658
Hepatitis toxic 13.78 9.92 52 433199 2900 55855916
Pneumonia streptococcal 13.68 9.92 36 433215 1652 55857164
Thrombocytopenia 13.67 9.92 1222 432029 135002 55723814
Deep vein thrombosis postoperative 13.66 9.92 7 433244 4034 55854782
Gallbladder adenocarcinoma 13.66 9.92 9 433242 94 55858722
Product odour abnormal 13.59 9.92 28 433223 1093 55857723
Transplant dysfunction 13.57 9.92 10 433241 4736 55854080
Barrett's oesophagus 13.56 9.92 20 433231 595 55858221
Large intestine infection 13.52 9.92 36 433215 1664 55857152
Parkinsonian rest tremor 13.50 9.92 9 433242 96 55858720
Feeling jittery 13.47 9.92 147 433104 11899 55846917
Dementia 13.46 9.92 196 433055 16962 55841854
Prescribed underdose 13.46 9.92 98 433153 20519 55838297
Dental discomfort 13.45 9.92 16 433235 384 55858432
Sensory loss 13.42 9.92 116 433135 8819 55849997
Urinary tract infection pseudomonal 13.41 9.92 23 433228 780 55858036
Goitre 13.39 9.92 81 433170 5492 55853324
Injection site bruising 13.38 9.92 212 433039 38309 55820507
Fear of eating 13.35 9.92 15 433236 338 55858478
Pancytopenia 13.34 9.92 822 432429 87893 55770923
Sweat discolouration 13.28 9.92 4 433247 3 55858813
Dolichocolon 13.28 9.92 4 433247 3 55858813
Weight decreased 13.24 9.92 2078 431173 238636 55620180
Ear pain 13.23 9.92 163 433088 30727 55828089
Aquagenic pruritus 13.23 9.92 6 433245 27 55858789
Breast cancer 13.13 9.92 281 432970 48552 55810264
Lipidosis 13.07 9.92 5 433246 13 55858803
Product taste abnormal 13.06 9.92 38 433213 1850 55856966
Hepatic rupture 13.06 9.92 6 433245 28 55858788
Acute graft versus host disease 13.01 9.92 8 433243 4167 55854649
Renal disorder 12.99 9.92 309 432942 29296 55829520
Gastric antral vascular ectasia 12.98 9.92 19 433232 561 55858255
Bone marrow failure 12.98 9.92 147 433104 28139 55830677
Sleep disorder due to a general medical condition 12.93 9.92 32 433219 9058 55849758
Hyperbilirubinaemia 12.91 9.92 128 433123 10107 55848709
Vertigo positional 12.85 9.92 47 433204 2582 55856234
Oedematous pancreatitis 12.84 9.92 17 433234 456 55858360
Salmonellosis 12.83 9.92 26 433225 1003 55857813
Chills 12.81 9.92 936 432315 101668 55757148
Joint destruction 12.79 9.92 12 433239 5043 55853773
Developmental hip dysplasia 12.78 9.92 30 433221 1281 55857535
Cholestasis 12.77 9.92 284 432967 26629 55832187
Renal haemangioma 12.73 9.92 6 433245 30 55858786
Derailment 12.71 9.92 7 433244 51 55858765
Injection site erythema 12.57 9.92 478 432773 76970 55781846
Hair injury 12.56 9.92 5 433246 15 55858801
Intestinal ulcer 12.54 9.92 28 433223 1156 55857660
Injection site swelling 12.54 9.92 248 433003 43330 55815486
Vitamin D deficiency 12.47 9.92 146 433105 12024 55846792
Product complaint 12.47 9.92 142 433109 11618 55847198
Essential hypertension 12.44 9.92 70 433181 4623 55854193
Congenital oral malformation 12.41 9.92 11 433240 184 55858632
Anaemia folate deficiency 12.41 9.92 11 433240 184 55858632
Circulatory collapse 12.36 9.92 227 433024 20576 55838240
Symmetrical drug-related intertriginous and flexural exanthema 12.35 9.92 15 433236 368 55858448
Choluria 12.34 9.92 10 433241 147 55858669
Dry skin 12.30 9.92 461 432790 46648 55812168
Sinonasal obstruction 12.30 9.92 12 433239 228 55858588
Soft tissue disorder 12.28 9.92 9 433242 4273 55854543
Cardiac steatosis 12.27 9.92 6 433245 33 55858783
Urine output increased 12.25 9.92 28 433223 1175 55857641
Haemorrhoids 12.18 9.92 221 433030 19985 55838831
Burning sensation 12.12 9.92 474 432777 48222 55810594
Antineutrophil cytoplasmic antibody positive 12.09 9.92 18 433233 540 55858276
Rapid eye movement sleep behaviour disorder 12.08 9.92 11 433240 191 55858625
Metastases to liver 12.06 9.92 107 433144 21479 55837337
Wrong technique in product usage process 12.04 9.92 348 432903 57820 55800996
Hypertensive cardiomyopathy 12.03 9.92 11 433240 192 55858624
Chronic graft versus host disease 12.00 9.92 5 433246 3251 55855565
Sputum retention 12.00 9.92 17 433234 487 55858329
Vitamin B12 deficiency 11.96 9.92 66 433185 4327 55854489
Urine chloride decreased 11.95 9.92 8 433243 86 55858730
Emotional disorder 11.94 9.92 146 433105 12149 55846667
Lichen planus 11.94 9.92 40 433211 2102 55856714
Interstitial lung disease 11.91 9.92 341 432910 56722 55802094
Blast cells present 11.89 9.92 15 433236 383 55858433
Tympanic membrane hyperaemia 11.88 9.92 4 433247 6 55858810
Electrolyte imbalance 11.87 9.92 200 433051 17833 55840983
Peptic ulcer perforation 11.85 9.92 10 433241 156 55858660
Prevertebral soft tissue swelling of cervical space 11.85 9.92 6 433245 36 55858780
DNA antibody 11.85 9.92 6 433245 36 55858780
Antithrombin III 11.80 9.92 10 433241 157 55858659
Oesophageal stenosis 11.79 9.92 50 433201 2943 55855873
Duodenitis 11.74 9.92 55 433196 3379 55855437
Product physical consistency issue 11.73 9.92 18 433233 555 55858261
Gastrointestinal polyp 11.72 9.92 6 433245 37 55858779
Extrasystoles 11.69 9.92 70 433181 4729 55854087
Metastases to bone 11.66 9.92 95 433156 19413 55839403
Presumed ocular histoplasmosis syndrome 11.62 9.92 3 433248 0 55858816
Respiratory tract procedural complication 11.62 9.92 3 433248 0 55858816
Occupational problem environmental 11.62 9.92 3 433248 0 55858816
Gastrointestinal polyp haemorrhage 11.60 9.92 10 433241 161 55858655
Muscular weakness 11.58 9.92 944 432307 103508 55755308
Speech disorder 11.57 9.92 374 432877 37119 55821697
Acquired oesophageal web 11.54 9.92 11 433240 203 55858613
Abortion induced 11.47 9.92 37 433214 9608 55849208
Shunt thrombosis 11.46 9.92 6 433245 39 55858777
Discoloured vomit 11.44 9.92 21 433230 752 55858064
Pelvic fracture 11.42 9.92 144 433107 12069 55846747
Escherichia urinary tract infection 11.40 9.92 132 433119 10843 55847973
Hypocoagulable state 11.40 9.92 25 433226 1020 55857796
Thrombosis 11.37 9.92 563 432688 58864 55799952
Product blister packaging issue 11.35 9.92 10 433241 166 55858650
Complication of device insertion 11.34 9.92 20 433231 6404 55852412
Infective exacerbation of chronic obstructive airways disease 11.31 9.92 26 433225 1095 55857721
Cholangitis 11.31 9.92 71 433180 4878 55853938
Bursitis 11.27 9.92 147 433104 27435 55831381
Hypervolaemia 11.26 9.92 275 432976 26183 55832633
Cleft palate 11.24 9.92 24 433227 961 55857855
Hallucination, visual 11.23 9.92 193 433058 17275 55841541
Hyperchromic anaemia 11.21 9.92 6 433245 41 55858775
Blood iron abnormal 11.20 9.92 6 433245 3371 55855445
Listless 11.18 9.92 45 433206 2587 55856229
Urticaria vesiculosa 11.17 9.92 4 433247 8 55858808
Febrile bone marrow aplasia 11.12 9.92 21 433230 6551 55852265
Hepatitis cholestatic 11.11 9.92 86 433165 6328 55852488
Secondary adrenocortical insufficiency 11.10 9.92 28 433223 1252 55857564
Respiratory disorder 11.10 9.92 189 433062 33768 55825048
Atrophic vulvovaginitis 11.08 9.92 33 433218 1628 55857188
Cytomegalovirus infection 11.07 9.92 95 433156 19201 55839615
Acinetobacter test positive 11.05 9.92 7 433244 68 55858748
Tendon sheath incision 11.05 9.92 7 433244 68 55858748
Cyanosis 11.02 9.92 177 433074 15633 55843183
Magnesium metabolism disorder 10.98 9.92 6 433245 43 55858773
Clostridium difficile colitis 10.97 9.92 204 433047 18534 55840282
Device dislocation 10.97 9.92 116 433135 22490 55836326
Gastritis bacterial 10.96 9.92 7 433244 69 55858747
Calcium metabolism disorder 10.96 9.92 9 433242 135 55858681
Osteochondritis 10.94 9.92 5 433246 23 55858793
Rotator cuff syndrome 10.86 9.92 142 433109 12001 55846815
BK virus infection 10.83 9.92 5 433246 3059 55855757
Dyskinesia 10.78 9.92 297 432954 28811 55830005
Gastroenteritis aeromonas 10.77 9.92 5 433246 24 55858792
Haematuria 10.75 9.92 278 432973 26709 55832107
White blood cell count increased 10.75 9.92 434 432817 44325 55814491
Gastric ulcer 10.68 9.92 238 433013 22325 55836491
Tongue discomfort 10.67 9.92 37 433214 1979 55856837
Anal incontinence 10.66 9.92 143 433108 12155 55846661
Poliomyelitis 10.65 9.92 6 433245 46 55858770
Hepatotoxicity 10.64 9.92 172 433079 30981 55827835
Epistaxis 10.63 9.92 624 432627 66399 55792417
Immune reconstitution inflammatory syndrome 10.63 9.92 17 433234 5657 55853159
Abnormal behaviour 10.61 9.92 217 433034 20055 55838761
Vulvar basal cell carcinoma 10.61 9.92 5 433246 25 55858791
Second primary malignancy 10.58 9.92 26 433225 7376 55851440
Blood creatine phosphokinase increased 10.57 9.92 286 432965 27666 55831150
Stress ulcer 10.54 9.92 6 433245 47 55858769
Tanning 10.47 9.92 7 433244 75 55858741
Abnormal dreams 10.45 9.92 117 433134 9532 55849284
Urinary incontinence 10.43 9.92 300 432951 29285 55829531
Body temperature increased 10.42 9.92 193 433058 34049 55824767
Seronegative arthritis 10.41 9.92 4 433247 2732 55856084
Potentiating drug interaction 10.35 9.92 60 433191 4006 55854810
Tension headache 10.30 9.92 47 433204 2856 55855960
Gingival bleeding 10.26 9.92 136 433115 11530 55847286
Renal arteriosclerosis 10.23 9.92 6 433245 50 55858766
Laryngeal oedema 10.22 9.92 73 433178 5237 55853579
Tachycardia 10.20 9.92 947 432304 104929 55753887
Intentional product misuse 10.20 9.92 310 432941 51194 55807622
No adverse event 10.17 9.92 208 433043 36166 55822650
Tangentiality 10.15 9.92 5 433246 28 55858788
Peripheral circulatory failure 10.14 9.92 22 433229 891 55857925
Haemoptysis 10.12 9.92 272 432979 26288 55832528
Aphasia 10.07 9.92 306 432945 30109 55828707
Deficiency of bile secretion 10.05 9.92 4 433247 12 55858804
Intraductal papillary breast neoplasm 10.05 9.92 4 433247 12 55858804
Pyonephrosis 10.05 9.92 4 433247 12 55858804
Device dependence 10.05 9.92 4 433247 12 55858804
Renal tuberculosis 10.01 9.92 5 433246 29 55858787
Gallbladder hypofunction 9.99 9.92 16 433235 512 55858304
Pulseless electrical activity 9.94 9.92 90 433161 6934 55851882
Breast cancer recurrent 9.93 9.92 10 433241 4065 55854751

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
Hypomagnesaemia 607.33 11.09 805 286520 18253 31391766
Drug abuse 413.02 11.09 140 287185 87618 31322401
Off label use 390.08 11.09 1723 285602 345551 31064468
Drug ineffective 301.24 11.09 2227 285098 393346 31016673
Chronic kidney disease 289.77 11.09 879 286446 37096 31372923
Hypocalcaemia 240.34 11.09 581 286744 21397 31388622
Toxicity to various agents 200.82 11.09 904 286421 180583 31229436
Tubulointerstitial nephritis 193.77 11.09 481 286844 18015 31392004
Gastrooesophageal reflux disease 162.44 11.09 673 286652 33198 31376821
Hypertrichosis 156.94 11.09 73 287252 288 31409731
Product use in unapproved indication 133.79 11.09 456 286869 98715 31311304
Completed suicide 128.81 11.09 413 286912 91101 31318918
Treatment failure 118.25 11.09 117 287208 40675 31369344
End stage renal disease 117.54 11.09 240 287085 7869 31402150
Product formulation issue 98.39 11.09 59 287266 428 31409591
Tetany 97.36 11.09 66 287259 606 31409413
Therapeutic product effect incomplete 92.98 11.09 158 287167 43538 31366481
Rheumatoid arthritis 86.81 11.09 190 287135 47619 31362400
Acute kidney injury 83.24 11.09 3209 284116 276505 31133514
Drug resistance 81.93 11.09 56 287269 23397 31386622
Death 77.38 11.09 2587 284738 357982 31052037
Foetal exposure during pregnancy 77.09 11.09 159 287166 40717 31369302
Hypoparathyroidism 73.98 11.09 52 287273 509 31409510
Renal injury 73.13 11.09 238 287087 10427 31399592
Drug interaction 71.86 11.09 2433 284892 206110 31203909
Lower respiratory tract infection 66.87 11.09 462 286863 27775 31382244
Intentional product use issue 66.42 11.09 227 287098 49120 31360899
Hyponatraemia 66.42 11.09 988 286337 72811 31337208
General physical health deterioration 60.82 11.09 696 286629 112739 31297280
Synovitis 60.56 11.09 18 287307 12265 31397754
Inappropriate antidiuretic hormone secretion 59.14 11.09 232 287093 11155 31398864
Subacute cutaneous lupus erythematosus 58.78 11.09 56 287269 868 31409151
Diarrhoea 58.11 11.09 3819 283506 348590 31061429
C-reactive protein abnormal 57.96 11.09 3 287322 7766 31402253
Dyspepsia 57.26 11.09 497 286828 32056 31377963
Drug intolerance 56.29 11.09 261 287064 51772 31358247
Renal tubular acidosis 55.12 11.09 82 287243 2075 31407944
Overdose 54.20 11.09 498 286827 84166 31325853
Intentional overdose 53.28 11.09 194 287131 41195 31368824
Abdominal pain upper 52.66 11.09 844 286481 63158 31346861
Infective pulmonary exacerbation of cystic fibrosis 51.22 11.09 152 287173 6332 31403687
Blood pressure fluctuation 49.48 11.09 81 287244 22655 31387364
Intentional product misuse 48.78 11.09 178 287147 37773 31372246
Hypertensive nephropathy 47.87 11.09 37 287288 424 31409595
Myalgia 47.75 11.09 974 286351 76284 31333735
Hypoparathyroidism secondary 45.54 11.09 23 287302 113 31409906
Drug ineffective for unapproved indication 45.00 11.09 57 287268 17733 31392286
Condition aggravated 44.74 11.09 1138 286187 162871 31247148
Drug hypersensitivity 44.34 11.09 432 286893 72167 31337852
Asthenia 44.11 11.09 2474 284851 222281 31187738
Suicide attempt 43.83 11.09 181 287144 37067 31372952
Hyperchlorhydria 43.04 11.09 40 287285 600 31409419
Gastric polyps 42.89 11.09 51 287274 1031 31408988
Hiatus hernia 42.31 11.09 149 287176 6798 31403221
Gastritis 42.28 11.09 322 287003 19970 31390049
Abdominal pain 42.19 11.09 1670 285655 144282 31265737
Infusion related reaction 42.00 11.09 259 287066 47796 31362223
Product use issue 41.19 11.09 323 287002 56436 31353583
Multiple organ dysfunction syndrome 40.75 11.09 408 286917 67795 31342224
Immune reconstitution inflammatory syndrome 40.29 11.09 12 287313 8166 31401853
Chromaturia 39.81 11.09 231 287094 13067 31396952
Loss of personal independence in daily activities 39.52 11.09 128 287197 28160 31381859
Drug dependence 39.13 11.09 92 287233 22487 31387532
Febrile neutropenia 38.94 11.09 825 286500 121024 31288995
Nephrogenic anaemia 38.83 11.09 69 287256 2034 31407985
Coma 37.43 11.09 219 287106 40931 31369088
Poisoning 36.04 11.09 25 287300 10366 31399653
Occupational dermatitis 33.85 11.09 16 287309 66 31409953
Haemophagocytic lymphohistiocytosis 33.25 11.09 34 287291 11644 31398375
Interstitial lung disease 33.17 11.09 376 286949 61027 31348992
Cardiogenic shock 32.99 11.09 99 287226 22309 31387710
Hypokalaemia 32.95 11.09 675 286650 52899 31357120
Premature baby 32.61 11.09 72 287253 17994 31392025
Respiratory arrest 32.53 11.09 125 287200 26132 31383887
Muscle spasms 32.44 11.09 830 286495 67488 31342531
Iron deficiency anaemia 32.32 11.09 169 287156 9190 31400829
Confusional state 32.10 11.09 1497 285828 131837 31278182
Dizziness 31.93 11.09 2154 285171 196993 31213026
Substance abuse 30.99 11.09 13 287312 7145 31402874
Chest pain 30.52 11.09 1324 286001 115633 31294386
Upper gastrointestinal haemorrhage 30.47 11.09 333 286992 22850 31387169
Mucormycosis 29.66 11.09 7 287318 5563 31404456
Fatigue 29.34 11.09 3468 283857 331738 31078281
Gastric mucosal hypertrophy 29.14 11.09 16 287309 96 31409923
Pathogen resistance 28.79 11.09 22 287303 8679 31401340
Blood magnesium decreased 28.53 11.09 116 287209 5670 31404349
Jejunal ulcer perforation 28.51 11.09 14 287311 64 31409955
Cytomegalovirus infection 28.48 11.09 121 287204 24586 31385433
Right hemisphere deficit syndrome 28.30 11.09 9 287316 7 31410012
Lip swelling 28.08 11.09 212 287113 13111 31396908
Mesenteric vein thrombosis 27.90 11.09 29 287296 502 31409517
Product label on wrong product 27.76 11.09 9 287316 8 31410011
Malignant neoplasm progression 27.57 11.09 527 286798 78471 31331548
Multiple-drug resistance 27.34 11.09 4 287321 4476 31405543
Therapy partial responder 26.72 11.09 13 287312 6549 31403470
Dysgeusia 26.35 11.09 327 286998 23139 31386880
Heart rate decreased 25.93 11.09 150 287175 28116 31381903
Drug use disorder 25.64 11.09 3 287322 3980 31406039
Device dependence 24.97 11.09 11 287314 37 31409982
Aplastic anaemia 24.86 11.09 28 287297 9175 31400844
Tetanus 24.76 11.09 12 287313 53 31409966
Oesophagitis 24.74 11.09 195 287130 12221 31397798
Vomiting 24.73 11.09 2354 284971 221619 31188400
Hepatocellular injury 24.53 11.09 106 287219 21438 31388581
Inappropriate schedule of product administration 24.12 11.09 320 287005 50503 31359516
Dyspnoea 24.03 11.09 3506 283819 339973 31070046
Diabetic nephropathy 23.79 11.09 55 287270 1966 31408053
Therapeutic response decreased 23.61 11.09 142 287183 26367 31383652
Lethargy 23.47 11.09 486 286839 38155 31371864
Exposure during pregnancy 23.40 11.09 26 287299 8572 31401447
Pneumocystis jirovecii pneumonia 23.18 11.09 86 287239 18165 31391854
Altered state of consciousness 23.11 11.09 105 287220 20946 31389073
Hepatic function abnormal 22.82 11.09 251 287074 40971 31369048
Granuloma annulare 22.65 11.09 15 287310 132 31409887
Meconium abnormal 22.54 11.09 12 287313 67 31409952
Apparent death 22.52 11.09 3 287322 3602 31406417
Rectal haemorrhage 22.51 11.09 458 286867 35846 31374173
Haematotoxicity 22.42 11.09 19 287306 7118 31402901
Lupus endocarditis 22.28 11.09 6 287319 0 31410019
Flatulence 22.13 11.09 266 287059 18682 31391337
Renal failure 22.10 11.09 1347 285978 121983 31288036
Stress 22.01 11.09 134 287191 24807 31385212
Acute interstitial pneumonitis 22.00 11.09 22 287303 363 31409656
Dry mouth 21.80 11.09 327 286998 24131 31385888
Venoocclusive liver disease 21.77 11.09 21 287304 7391 31402628
Respiratory tract infection 21.60 11.09 249 287076 17312 31392707
Weight increased 21.39 11.09 580 286745 82367 31327652
Low birth weight baby 21.35 11.09 19 287306 6951 31403068
Myelosuppression 21.19 11.09 67 287258 14853 31395166
Blood pressure diastolic abnormal 21.19 11.09 5 287320 3974 31406045
Ageusia 21.10 11.09 151 287174 9180 31400839
Tenosynovitis 21.06 11.09 6 287319 4204 31405815
Gastrointestinal haemorrhage 20.97 11.09 932 286393 81617 31328402
Blood pressure systolic increased 20.85 11.09 98 287227 19372 31390647
Obstructive airways disorder 20.84 11.09 53 287272 12611 31397408
Cystitis haemorrhagic 20.75 11.09 11 287314 5278 31404741
Barrett's oesophagus 20.49 11.09 23 287302 436 31409583
Liver function test abnormal 20.24 11.09 380 286945 29312 31380707
Multimorbidity 20.05 11.09 29 287296 715 31409304
Accidental exposure to product 19.79 11.09 47 287278 11448 31398571
Chronic kidney disease-mineral and bone disorder 19.77 11.09 21 287304 373 31409646
Cerebral infarction 19.70 11.09 146 287179 25831 31384188
Type I hypersensitivity 19.54 11.09 36 287289 1092 31408927
Respiratory depression 19.34 11.09 67 287258 14443 31395576
Sopor 19.28 11.09 48 287277 11504 31398515
Abnormal loss of weight 19.22 11.09 77 287248 3738 31406281
Pneumatosis intestinalis 19.11 11.09 5 287320 3706 31406313
Blood copper increased 19.11 11.09 7 287318 12 31410007
Chronic graft versus host disease 18.98 11.09 8 287317 4384 31405635
Intercepted product preparation error 18.91 11.09 3 287322 3161 31406858
Blood gastrin increased 18.83 11.09 8 287317 24 31409995
Veillonella infection 18.56 11.09 5 287320 0 31410019
Gastric xanthoma 18.56 11.09 5 287320 0 31410019
Cerebral atrophy congenital 18.48 11.09 10 287315 58 31409961
Brain scan abnormal 18.28 11.09 30 287295 828 31409191
Nephropathy 18.28 11.09 98 287227 5381 31404638
Indifference 18.19 11.09 13 287312 131 31409888
Ceruloplasmin increased 18.17 11.09 6 287319 6 31410013
Post transplant lymphoproliferative disorder 18.10 11.09 17 287308 6059 31403960
Psoriatic arthropathy 17.98 11.09 106 287219 19777 31390242
Gastric pH decreased 17.87 11.09 13 287312 135 31409884
Nephritis 17.68 11.09 52 287273 2155 31407864
Oesophageal perforation 17.66 11.09 32 287293 958 31409061
Faeces discoloured 17.64 11.09 197 287128 13589 31396430
Lipodystrophy acquired 17.58 11.09 4 287321 3260 31406759
Soft tissue mass 17.55 11.09 29 287296 805 31409214
Bone marrow failure 17.37 11.09 166 287159 27842 31382177
Graft versus host disease in gastrointestinal tract 17.33 11.09 5 287320 3474 31406545
Helicobacter test positive 17.32 11.09 28 287297 763 31409256
Product substitution issue 17.10 11.09 145 287180 9287 31400732
Blood chromogranin A increased 16.97 11.09 15 287310 210 31409809
Paraesthesia 16.97 11.09 645 286680 55426 31354593
Steatorrhoea 16.90 11.09 26 287299 678 31409341
Hepatic encephalopathy 16.88 11.09 194 287131 13477 31396542
Urine calcium decreased 16.86 11.09 6 287319 9 31410010
Labelled drug-drug interaction medication error 16.80 11.09 188 287137 12975 31397044
Ischaemic stroke 16.76 11.09 231 287094 16740 31393279
Gastroenteritis eosinophilic 16.75 11.09 13 287312 150 31409869
Nephrosclerosis 16.72 11.09 30 287295 891 31409128
Carcinoid tumour of the gastrointestinal tract 16.66 11.09 9 287316 52 31409967
Ventricular flutter 16.62 11.09 10 287315 73 31409946
Immunosuppressant drug level increased 16.60 11.09 93 287232 5192 31404827
Stoma site haemorrhage 16.46 11.09 27 287298 745 31409274
Graft versus host disease in skin 16.45 11.09 6 287319 3591 31406428
Lymphoma 16.36 11.09 48 287277 10895 31399124
Cardio-respiratory arrest 16.27 11.09 351 286974 51375 31358644
Colorectal cancer 16.25 11.09 12 287313 4817 31405202
Blood pressure increased 16.10 11.09 575 286750 79058 31330961
Coronary artery bypass 16.05 11.09 12 287313 4787 31405232
Helicobacter infection 16.03 11.09 50 287275 2141 31407878
Ischaemic nephropathy 16.01 11.09 7 287318 23 31409996
International normalised ratio increased 15.60 11.09 528 286797 44695 31365324
Aggression 15.51 11.09 241 287084 37050 31372969
Therapeutic product effect decreased 15.40 11.09 198 287127 31424 31378595
Oropharyngeal blistering 15.36 11.09 13 287312 171 31409848
Systemic infection 15.36 11.09 6 287319 3443 31406576
Diffuse large B-cell lymphoma recurrent 15.34 11.09 4 287321 2971 31407048
Febrile bone marrow aplasia 15.23 11.09 30 287295 7816 31402203
Diverticulum 15.22 11.09 106 287219 6388 31403631
Neuroleptic malignant syndrome 15.21 11.09 90 287235 16779 31393240
Malignant spinal cord compression 15.14 11.09 12 287313 143 31409876
Degenerative mitral valve disease 15.06 11.09 14 287311 210 31409809
Neutropenic sepsis 14.99 11.09 175 287150 12204 31397815
Endophthalmitis 14.97 11.09 7 287318 3609 31406410
Bronchopulmonary aspergillosis 14.97 11.09 68 287257 13566 31396453
Oesophageal stenosis 14.96 11.09 40 287285 1568 31408451
Virologic failure 14.96 11.09 5 287320 3160 31406859
Epstein-Barr virus infection 14.91 11.09 25 287300 6928 31403091
Macrocephaly 14.86 11.09 20 287305 460 31409559
Latent tetany 14.85 11.09 4 287321 0 31410019
Dermatitis infected 14.82 11.09 10 287315 91 31409928
Pancreatic abscess 14.82 11.09 9 287316 67 31409952
Posterior reversible encephalopathy syndrome 14.80 11.09 40 287285 9327 31400692
Status epilepticus 14.76 11.09 58 287267 12048 31397971
Bladder cancer 14.68 11.09 76 287249 14649 31395370
Blood calcium decreased 14.68 11.09 141 287184 9353 31400666
Jaundice 14.67 11.09 369 286956 29918 31380101
Body temperature decreased 14.60 11.09 56 287269 11714 31398305
Dystonia 14.46 11.09 46 287279 10179 31399840
Blood pressure systolic abnormal 14.37 11.09 5 287320 3082 31406937
BK virus infection 14.32 11.09 15 287310 5080 31404939
Rebound acid hypersecretion 14.30 11.09 10 287315 97 31409922
Acute graft versus host disease 14.26 11.09 21 287304 6132 31403887
Gastric neoplasm 14.19 11.09 9 287316 73 31409946
Dehydration 14.18 11.09 1259 286066 117852 31292167
Alveolitis 14.16 11.09 39 287286 1556 31408463
Product substitution error 14.12 11.09 6 287319 18 31410001
Progressive multifocal leukoencephalopathy 14.07 11.09 40 287285 9173 31400846
Cerebral artery thrombosis 14.04 11.09 25 287300 738 31409281
Faeces pale 14.04 11.09 34 287291 1253 31408766
Pyloric stenosis 13.92 11.09 25 287300 743 31409276
Laboratory test 13.86 11.09 5 287320 8 31410011
Akathisia 13.85 11.09 28 287297 7225 31402794
Viral mutation identified 13.75 11.09 4 287321 2765 31407254
Unintentional medical device removal 13.75 11.09 3 287322 2517 31407502
Cytomegalovirus chorioretinitis 13.64 11.09 7 287318 3421 31406598
Oral administration complication 13.57 11.09 8 287317 56 31409963
Incorrect dose administered 13.56 11.09 235 287090 35517 31374502
Therapy non-responder 13.56 11.09 220 287105 33591 31376428
Bone erosion 13.47 11.09 7 287318 3396 31406623
Breast inflammation 13.44 11.09 6 287319 21 31409998
Uveitis 13.28 11.09 26 287299 6790 31403229
Pharyngeal oedema 13.23 11.09 94 287231 5702 31404317
Ectopic gastric mucosa 13.16 11.09 5 287320 10 31410009
Splenomegaly 13.11 11.09 186 287139 13563 31396456
Discoloured vomit 13.09 11.09 19 287306 470 31409549
Abdominal sepsis 13.05 11.09 28 287297 951 31409068
Pancreatic pseudocyst 13.02 11.09 25 287300 783 31409236
Blood sodium decreased 12.97 11.09 203 287122 15112 31394907
Polymyositis 12.96 11.09 35 287290 1380 31408639
Incorrect route of product administration 12.95 11.09 58 287267 11615 31398404
Asthma 12.87 11.09 291 287034 42320 31367699
Product complaint 12.85 11.09 90 287235 5434 31404585
Hepatitis B reactivation 12.83 11.09 8 287317 3510 31406509
Oxygen saturation decreased 12.77 11.09 343 286982 48772 31361247
Nicotine dependence 12.76 11.09 19 287306 481 31409538
Prostate cancer 12.75 11.09 252 287073 37349 31372670
Somatosensory evoked potentials abnormal 12.74 11.09 11 287314 149 31409870
Yellow skin 12.74 11.09 43 287282 1920 31408099
Rales 12.72 11.09 127 287198 8512 31401507
Muscular weakness 12.69 11.09 720 286605 64728 31345291
Lymphangitis 12.69 11.09 20 287305 533 31409486
Blood pressure diastolic increased 12.67 11.09 12 287313 4261 31405758
Intestinal fistula infection 12.64 11.09 4 287321 3 31410016
Abdominal discomfort 12.60 11.09 580 286745 50987 31359032
Intestinal infarction 12.56 11.09 19 287306 488 31409531
Agitated depression 12.51 11.09 13 287312 225 31409794
Pleural mass 12.50 11.09 8 287317 66 31409953
Periodontal disease 12.47 11.09 24 287301 753 31409266
Infection 12.46 11.09 611 286714 81320 31328699
Myocardial infarction 12.43 11.09 873 286452 112581 31297438
Pancreatitis 12.42 11.09 418 286907 35353 31374666
Electrocardiogram QRS complex prolonged 12.40 11.09 12 287313 4217 31405802
Aspergillus infection 12.36 11.09 58 287267 11470 31398549
Oropharyngeal swelling 12.32 11.09 18 287307 448 31409571
Red blood cell analysis abnormal 12.28 11.09 5 287320 13 31410006
Antipsychotic drug level decreased 12.26 11.09 26 287299 876 31409143
Pseudoporphyria 12.21 11.09 15 287310 314 31409705
Hepatitis B 12.20 11.09 21 287304 5760 31404259
Syncope 12.17 11.09 913 286412 84269 31325750
Amino acid level increased 12.09 11.09 17 287308 408 31409611
Herpes simplex 12.06 11.09 18 287307 5227 31404792
Fear 12.02 11.09 48 287277 9926 31400093
Prostate cancer stage IV 11.99 11.09 3 287322 2292 31407727
Hepatitis cholestatic 11.99 11.09 108 287217 7038 31402981
Aspartate aminotransferase increased 11.98 11.09 456 286869 62263 31347756
Blister 11.96 11.09 261 287064 20675 31389344
Hypocalcaemic seizure 11.96 11.09 6 287319 29 31409990
Dry throat 11.90 11.09 44 287281 2056 31407963
Polyomavirus-associated nephropathy 11.83 11.09 9 287316 3559 31406460
Leukopenia 11.81 11.09 417 286908 57411 31352608
Intestinal angioedema 11.76 11.09 12 287313 203 31409816
Wrong technique in product usage process 11.76 11.09 222 287103 33121 31376898
Cardiac arrest 11.70 11.09 674 286651 88388 31321631
Cerebral vasoconstriction 11.67 11.09 12 287313 205 31409814
Cholelithiasis obstructive 11.65 11.09 4 287321 5 31410014
Suspected suicide 11.64 11.09 12 287313 4095 31405924
Pulmonary embolism 11.64 11.09 875 286450 80771 31329248
Lymphopenia 11.61 11.09 79 287246 14250 31395769
Catatonia 11.59 11.09 16 287309 4798 31405221
Hallucination 11.56 11.09 523 286802 45887 31364132
Device malfunction 11.55 11.09 44 287281 9222 31400797
Pedal pulse decreased 11.53 11.09 5 287320 16 31410003
Appendicitis 11.53 11.09 59 287266 11406 31398613
COVID-19 11.50 11.09 394 286931 54427 31355592
Swollen tongue 11.48 11.09 172 287153 12690 31397329
No adverse event 11.46 11.09 118 287207 19507 31390512
Cytopenia 11.45 11.09 56 287269 10954 31399065
Neonatal respiratory distress syndrome 11.42 11.09 11 287314 3874 31406145
Hypoosmolar state 11.41 11.09 8 287317 78 31409941
Accidental death 11.39 11.09 3 287322 2214 31407805
Occupational exposure to air contaminants 11.37 11.09 10 287315 139 31409880
Fracture 11.36 11.09 25 287300 6255 31403764
Claustrophobia 11.35 11.09 12 287313 212 31409807
Crohn's disease 11.32 11.09 70 287255 4051 31405968
COVID-19 treatment 11.31 11.09 13 287312 253 31409766
Incision site cellulitis 11.24 11.09 4 287321 6 31410013
Pulmonary resection 11.24 11.09 4 287321 6 31410013
Cytomegalovirus viraemia 11.18 11.09 28 287297 6697 31403322
Urinary tract discomfort 11.17 11.09 9 287316 110 31409909
Musculoskeletal stiffness 11.16 11.09 287 287038 41038 31368981
Prosthesis user 11.14 11.09 3 287322 0 31410019
Carotid pulse abnormal 11.14 11.09 3 287322 0 31410019
Mean platelet volume abnormal 11.14 11.09 3 287322 0 31410019
Stertor 11.14 11.09 3 287322 0 31410019
Anal chlamydia infection 11.14 11.09 3 287322 0 31410019
Aspiration pleural cavity abnormal 11.14 11.09 3 287322 0 31410019
Platelet production decreased 11.14 11.09 3 287322 0 31410019
Vitamin B12 deficiency 11.10 11.09 62 287263 3457 31406562

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
Hypomagnesaemia 1222.35 10.19 1587 579233 39177 70308447
Drug ineffective 1006.21 10.19 4130 576690 935622 69412002
Synovitis 812.73 10.19 65 580755 129163 70218461
Rheumatoid arthritis 804.63 10.19 723 580097 291082 70056542
Drug intolerance 692.10 10.19 503 580317 225184 70122440
Off label use 634.56 10.19 3537 577283 739523 69608101
Tubulointerstitial nephritis 623.86 10.19 1035 579785 32041 70315583
Pemphigus 589.82 10.19 20 580800 83016 70264608
Hand deformity 559.42 10.19 38 580782 86444 70261180
Treatment failure 543.07 10.19 250 580570 143892 70203732
Anti-cyclic citrullinated peptide antibody positive 541.64 10.19 6 580814 70179 70277445
Contraindicated product administered 495.54 10.19 241 580579 134371 70213253
Drug interaction 494.68 10.19 5033 575787 376408 69971216
Hypocalcaemia 481.96 10.19 1107 579713 43752 70303872
Hyponatraemia 454.26 10.19 2543 578277 157544 70190080
Drug abuse 445.01 10.19 333 580487 146923 70200701
Chronic kidney disease 414.38 10.19 1270 579550 59787 70287837
Infusion related reaction 382.20 10.19 643 580177 196891 70150733
Acute kidney injury 380.31 10.19 5721 575099 468903 69878721
Systemic lupus erythematosus 380.28 10.19 179 580641 101723 70245901
Therapeutic product effect decreased 377.69 10.19 368 580452 142650 70204974
Wound 366.03 10.19 175 580645 98557 70249067
Rheumatoid factor positive 361.22 10.19 7 580813 48393 70299231
Pericarditis 342.90 10.19 132 580688 84573 70263051
Maternal exposure during pregnancy 339.33 10.19 268 580552 115077 70232547
Joint swelling 338.00 10.19 1010 579810 252201 70095423
Completed suicide 332.06 10.19 867 579953 226268 70121356
Glossodynia 321.05 10.19 153 580667 86334 70261290
Duodenal ulcer perforation 309.61 10.19 30 580790 51082 70296542
Drug hypersensitivity 299.50 10.19 1121 579699 261338 70086286
Subacute cutaneous lupus erythematosus 299.36 10.19 232 580588 2981 70344643
Arthropathy 280.56 10.19 499 580321 149558 70198066
Sleep disorder due to general medical condition, insomnia type 242.34 10.19 12 580808 35720 70311904
Hepatic enzyme increased 235.69 10.19 591 580229 156399 70191225
C-reactive protein abnormal 235.37 10.19 22 580798 38557 70309067
Therapeutic product effect incomplete 226.47 10.19 396 580424 119486 70228138
Muscle injury 219.50 10.19 28 580792 38466 70309158
Helicobacter infection 218.26 10.19 91 580729 55565 70292059
Discomfort 218.19 10.19 328 580492 105108 70242516
Folliculitis 217.80 10.19 42 580778 42528 70305096
Product use issue 209.42 10.19 762 580058 179175 70168449
Gastrooesophageal reflux disease 199.98 10.19 1352 579468 89487 70258137
Alopecia 188.56 10.19 909 579911 197581 70150043
Toxicity to various agents 185.14 10.19 2119 578701 380053 69967571
Tetany 184.85 10.19 151 580669 2103 70345521
Product use in unapproved indication 179.66 10.19 981 579839 206497 70141127
Hypertrichosis 177.55 10.19 114 580706 1060 70346564
Diarrhoea 172.90 10.19 7951 572869 775390 69572234
Orthostatic hypotension 162.15 10.19 845 579975 50898 70296726
Blood calcium decreased 159.70 10.19 560 580260 28286 70319338
Intentional product use issue 158.85 10.19 481 580339 119661 70227963
Hypersensitivity 158.17 10.19 1166 579654 228646 70118978
Creatinine renal clearance decreased 155.30 10.19 397 580423 16803 70330821
End stage renal disease 153.33 10.19 304 580516 10829 70336795
Hypoparathyroidism 147.29 10.19 96 580724 918 70346706
Abdominal pain 144.28 10.19 3745 577075 338382 70009242
Hypokalaemia 142.23 10.19 1672 579148 129516 70218108
Nasopharyngitis 140.47 10.19 1154 579666 221052 70126572
Exposure during pregnancy 137.28 10.19 323 580497 87394 70260230
Irritable bowel syndrome 136.31 10.19 129 580691 50721 70296903
Product formulation issue 132.17 10.19 84 580736 766 70346858
Constipation 131.34 10.19 2845 577975 249593 70098031
Red blood cell sedimentation rate abnormal 129.27 10.19 7 580813 19296 70328328
Sedation complication 128.91 10.19 317 580503 13093 70334531
Drug resistance 126.47 10.19 78 580742 38112 70309512
Rheumatic fever 126.28 10.19 4 580816 17656 70329968
Balance disorder 125.44 10.19 1208 579612 88920 70258704
Impaired healing 123.62 10.19 265 580555 74109 70273515
Condition aggravated 114.68 10.19 2647 578173 424988 69922636
Swelling 113.81 10.19 991 579829 187548 70160076
Infection 112.23 10.19 1143 579677 209642 70137982
Psoriatic arthropathy 111.68 10.19 226 580594 64545 70283079
Cognitive disorder 110.96 10.19 867 579953 60089 70287535
Musculoskeletal stiffness 109.79 10.19 733 580087 147027 70200597
General physical health deterioration 103.00 10.19 1338 579482 234693 70112931
Infective pulmonary exacerbation of cystic fibrosis 101.97 10.19 273 580547 11885 70335739
Vomiting 101.24 10.19 5877 574943 587234 69760390
Stomatitis 100.83 10.19 627 580193 127884 70219740
Cholecystitis chronic 99.15 10.19 230 580590 9146 70338478
Gastritis 98.28 10.19 664 580156 43927 70303697
Ill-defined disorder 94.38 10.19 191 580629 54550 70293074
Asthenia 93.63 10.19 4613 576207 453053 69894571
Gastrointestinal haemorrhage 93.30 10.19 1613 579207 135795 70211829
Muscle spasms 91.20 10.19 1770 579050 152276 70195348
Dizziness 89.74 10.19 4653 576167 459488 69888136
Abdominal discomfort 87.80 10.19 1233 579587 213425 70134199
Intentional overdose 87.02 10.19 462 580358 97973 70249651
Gastric polyps 87.00 10.19 123 580697 3298 70344326
Blood pressure systolic increased 86.30 10.19 215 580605 57044 70290580
Fall 85.83 10.19 4452 576368 439644 69907980
Coma 85.18 10.19 424 580396 91420 70256204
Lethargy 85.06 10.19 967 579853 74283 70273341
Therapeutic response decreased 83.87 10.19 225 580595 58228 70289396
Inappropriate antidiuretic hormone secretion 82.75 10.19 394 580426 22882 70324742
Chest pain 80.99 10.19 2660 578160 248600 70099024
Liver function test abnormal 80.89 10.19 811 580009 60335 70287289
Overdose 78.99 10.19 949 579871 168796 70178828
Blood pressure fluctuation 78.87 10.19 235 580585 58777 70288847
Abdominal pain upper 78.22 10.19 2108 578712 191494 70156130
Myalgia 77.82 10.19 1862 578958 166030 70181594
Bone erosion 77.55 10.19 15 580805 15158 70332466
Rheumatoid nodule 76.78 10.19 15 580805 15052 70332572
Weight increased 75.98 10.19 1462 579358 240869 70106755
Dyspepsia 74.17 10.19 1082 579738 87995 70259629
Gastric pH decreased 73.63 10.19 57 580763 731 70346893
Upper gastrointestinal haemorrhage 73.21 10.19 542 580278 36935 70310689
Hypoparathyroidism secondary 73.15 10.19 35 580785 169 70347455
Renal failure 72.81 10.19 2046 578774 187024 70160600
Swollen tongue 70.80 10.19 533 580287 36513 70311111
Hypertensive nephropathy 70.52 10.19 58 580762 816 70346808
Confusional state 70.36 10.19 2923 577897 281475 70066149
Dyspnoea 69.02 10.19 7256 573564 762804 69584820
Hiatus hernia 68.18 10.19 348 580472 20786 70326838
Sinusitis 67.70 10.19 976 579844 168219 70179405
Arthralgia 67.57 10.19 3401 577419 499989 69847635
Renal injury 67.40 10.19 286 580534 15808 70331816
Red blood cell sedimentation rate increased 65.62 10.19 136 580684 38506 70309118
Tenosynovitis 65.04 10.19 17 580803 13959 70333665
Therapy non-responder 64.68 10.19 367 580453 76548 70271076
Lip swelling 64.55 10.19 489 580331 33565 70314059
Pulmonary embolism 62.05 10.19 1694 579126 154173 70193451
Respiratory arrest 60.98 10.19 231 580589 53702 70293922
Abortion spontaneous 59.10 10.19 78 580742 26401 70321223
Syncope 58.52 10.19 1774 579046 163935 70183689
Haematemesis 57.84 10.19 633 580187 48164 70299460
Loss of personal independence in daily activities 57.77 10.19 432 580388 84478 70263146
Suicide attempt 57.75 10.19 397 580423 79113 70268511
Dehydration 57.21 10.19 2330 578490 223812 70123812
Paraesthesia 56.31 10.19 1576 579244 143961 70203663
Device expulsion 55.55 10.19 60 580760 22186 70325438
Hip arthroplasty 55.34 10.19 90 580730 27950 70319674
Blood pressure diastolic abnormal 55.15 10.19 29 580791 15475 70332149
Enthesopathy 55.01 10.19 11 580809 10858 70336766
Fibromyalgia 54.15 10.19 205 580615 47669 70299955
Pancreatitis acute 53.76 10.19 587 580233 44637 70302987
Drug ineffective for unapproved indication 52.56 10.19 152 580668 38386 70309238
Rectal haemorrhage 51.82 10.19 792 580028 65039 70282585
Swelling face 51.69 10.19 765 580055 62399 70285225
Sopor 51.45 10.19 112 580708 31155 70316469
Accidental exposure to product 50.84 10.19 95 580725 27956 70319668
International normalised ratio increased 50.64 10.19 936 579884 79790 70267834
Aplastic anaemia 50.19 10.19 38 580782 16678 70330946
Panniculitis 49.65 10.19 13 580807 10663 70336961
Intentional product misuse 49.49 10.19 415 580405 79180 70268444
Chromaturia 49.26 10.19 346 580474 23182 70324442
Blood pressure systolic abnormal 49.18 10.19 22 580798 12887 70334737
Blood sodium decreased 48.42 10.19 426 580394 30572 70317052
Deep vein thrombosis 48.27 10.19 1221 579599 109821 70237803
Pregnancy 48.19 10.19 75 580745 23706 70323918
Hallucination 47.76 10.19 884 579936 75376 70272248
Drug tolerance decreased 47.63 10.19 11 580809 9822 70337802
Poisoning 47.14 10.19 70 580750 22552 70325072
Sedation 46.85 10.19 587 580233 46144 70301480
Flatulence 46.50 10.19 498 580322 37683 70309941
Malignant neoplasm progression 46.35 10.19 709 580111 121030 70226594
Cytomegalovirus infection 45.78 10.19 169 580651 39589 70308035
Abnormal loss of weight 45.59 10.19 154 580666 7630 70339994
Nephrogenic anaemia 45.32 10.19 95 580725 3523 70344101
Immune reconstitution inflammatory syndrome 45.18 10.19 25 580795 12965 70334659
Malaise 45.16 10.19 4124 576696 428808 69918816
Urinary tract infection 44.96 10.19 2479 578341 246290 70101334
Therapy partial responder 44.86 10.19 23 580797 12451 70335173
Blood magnesium decreased 44.18 10.19 239 580581 14602 70333022
Nausea 43.82 10.19 7769 573051 844319 69503305
Oesophagitis 43.34 10.19 326 580494 22326 70325298
Pain 42.73 10.19 4503 576317 624313 69723311
Premature delivery 42.40 10.19 68 580752 21236 70326388
Dysgeusia 42.27 10.19 604 580216 48898 70298726
Type I hypersensitivity 41.06 10.19 93 580727 3639 70343985
Jaundice 41.05 10.19 607 580213 49501 70298123
Iron deficiency anaemia 40.78 10.19 326 580494 22746 70324878
Tremor 40.62 10.19 1609 579211 154015 70193609
Vision blurred 40.57 10.19 1042 579778 93942 70253682
Rash 40.29 10.19 3616 577204 506946 69840678
Rhabdomyolysis 40.17 10.19 1048 579772 94712 70252912
Heart rate decreased 40.08 10.19 320 580500 61695 70285929
Adverse event 39.46 10.19 240 580580 49221 70298403
Occupational dermatitis 39.44 10.19 20 580800 112 70347512
Mucormycosis 38.75 10.19 9 580811 8005 70339619
Biliary dyskinesia 38.59 10.19 70 580750 2329 70345295
Gallbladder disorder 38.58 10.19 263 580557 17449 70330175
Grip strength decreased 38.39 10.19 43 580777 15642 70331982
Metabolic alkalosis 38.19 10.19 96 580724 4020 70343604
Anaemia 37.92 10.19 3815 577005 399608 69948016
Labelled drug-drug interaction medication error 37.91 10.19 332 580488 23795 70323829
Disorientation 37.52 10.19 675 580145 57248 70290376
Faeces discoloured 37.11 10.19 359 580461 26450 70321174
Obstructive airways disorder 37.09 10.19 101 580719 26012 70321612
Live birth 36.87 10.19 35 580785 13744 70333880
Renal tubular acidosis 36.84 10.19 84 580736 3302 70344322
Interstitial lung disease 36.74 10.19 619 580201 104066 70243558
Body temperature decreased 36.31 10.19 117 580703 28555 70319069
Cogwheel rigidity 36.10 10.19 77 580743 2891 70344733
Multiple-drug resistance 36.08 10.19 8 580812 7347 70340277
Atrial fibrillation 35.68 10.19 1849 578971 182499 70165125
Breast cancer stage III 35.45 10.19 6 580814 6675 70340949
Chronic obstructive pulmonary disease 35.31 10.19 859 579961 76782 70270842
Angioedema 35.29 10.19 753 580067 65857 70281767
Pathogen resistance 35.22 10.19 34 580786 13245 70334379
Haemophagocytic lymphohistiocytosis 35.03 10.19 67 580753 19545 70328079
Product substitution issue 34.61 10.19 265 580555 18248 70329376
Muscle spasticity 34.53 10.19 68 580752 19621 70328003
Myelosuppression 34.15 10.19 129 580691 30016 70317608
Substance abuse 34.11 10.19 19 580801 9818 70337806
Catatonia 34.04 10.19 12 580808 8121 70339503
Peripheral swelling 33.86 10.19 1587 579233 234976 70112648
Blister 33.80 10.19 599 580221 99927 70247697
Burning mouth syndrome 33.28 10.19 30 580790 481 70347143
Post transplant lymphoproliferative disorder 32.93 10.19 23 580797 10522 70337102
Inappropriate schedule of product administration 32.72 10.19 652 580168 106903 70240721
Unintentional medical device removal 32.52 10.19 9 580811 7115 70340509
Hyperchlorhydria 32.45 10.19 56 580764 1790 70345834
Gastrointestinal disorder 32.40 10.19 638 580182 104789 70242835
Neutropenic sepsis 32.19 10.19 328 580492 24502 70323122
Palpitations 31.98 10.19 1158 579662 109595 70238029
Nephropathy 31.81 10.19 150 580670 8675 70338949
Blood pressure increased 31.70 10.19 1242 579578 187275 70160349
Chronic kidney disease-mineral and bone disorder 31.70 10.19 33 580787 637 70346987
Toxic epidermal necrolysis 31.55 10.19 477 580343 39080 70308544
Device use error 31.44 10.19 8 580812 6688 70340936
Epstein-Barr virus infection 31.42 10.19 37 580783 13161 70334463
Facet joint syndrome 31.33 10.19 6 580814 6107 70341517
Cardiogenic shock 31.19 10.19 172 580648 36135 70311489
Hepatic encephalopathy 31.02 10.19 297 580523 21821 70325803
Device dependence 30.94 10.19 13 580807 43 70347581
Multimorbidity 30.83 10.19 43 580777 1138 70346486
Poisoning deliberate 30.72 10.19 58 580762 17002 70330622
Hepatitis cholestatic 30.69 10.19 193 580627 12457 70335167
Caesarean section 30.46 10.19 30 580790 11577 70336047
Diabetic nephropathy 30.40 10.19 69 580751 2704 70344920
Transient ischaemic attack 30.32 10.19 537 580283 45407 70302217
H1N1 influenza 30.22 10.19 63 580757 2327 70345297
Feeling of despair 30.22 10.19 67 580753 2584 70345040
Breast cancer stage II 30.21 10.19 4 580816 5342 70342282
C-reactive protein increased 30.10 10.19 682 580138 109835 70237789
Cross sensitivity reaction 30.08 10.19 79 580741 3399 70344225
Right hemisphere deficit syndrome 29.77 10.19 9 580811 6 70347618
Pneumonia 29.77 10.19 5429 575391 590803 69756821
Pancreatitis 29.60 10.19 697 580123 61971 70285653
Feeling of body temperature change 29.60 10.19 99 580721 4880 70342744
Red blood cell sedimentation rate 29.42 10.19 3 580817 4907 70342717
Depersonalisation/derealisation disorder 29.40 10.19 52 580768 1696 70345928
Stress 29.33 10.19 386 580434 67580 70280044
Palatal oedema 29.27 10.19 43 580777 1195 70346429
Mouth swelling 28.88 10.19 103 580717 5246 70342378
Dilatation intrahepatic duct acquired 28.80 10.19 32 580788 667 70346957
Cytomegalovirus viraemia 28.64 10.19 32 580788 11653 70335971
Device difficult to use 28.51 10.19 28 580792 10821 70336803
Hypophosphataemia 28.49 10.19 230 580590 16096 70331528
Acute graft versus host disease 28.38 10.19 22 580798 9540 70338084
Product complaint 28.07 10.19 184 580636 12047 70335577
Gastric mucosal hypertrophy 28.00 10.19 20 580800 225 70347399
Disability 27.81 10.19 50 580770 14933 70332691
Presyncope 27.78 10.19 446 580374 36992 70310632
Hypoaesthesia oral 27.60 10.19 184 580636 12116 70335508
Derealisation 27.53 10.19 47 580773 1489 70346135
Dry mouth 27.52 10.19 764 580056 69693 70277931
Blood pressure diastolic decreased 27.49 10.19 113 580707 25667 70321957
Blood cholesterol increased 27.48 10.19 368 580452 64236 70283388
Haemoglobin decreased 27.41 10.19 1992 578828 203167 70144457
Non-cardiac chest pain 27.39 10.19 146 580674 8869 70338755
Hallucinations, mixed 27.37 10.19 114 580706 6248 70341376
Blood potassium decreased 27.35 10.19 494 580326 41927 70305697
Breast cancer stage I 27.31 10.19 8 580812 6094 70341530
Arthritis 27.15 10.19 603 580217 97377 70250247
Colorectal cancer 27.08 10.19 18 580802 8452 70339172
Hyperhidrosis 26.93 10.19 1327 579493 130259 70217365
Chronic graft versus host disease 26.65 10.19 11 580809 6759 70340865
Injection site pain 26.60 10.19 746 580074 116873 70230751
Cholelithiasis 26.33 10.19 539 580281 46801 70300823
Mania 26.30 10.19 235 580585 16939 70330685
Drooling 26.27 10.19 101 580719 5335 70342289
Blood gastrin increased 26.27 10.19 11 580809 36 70347588
Oral pain 26.16 10.19 358 580462 28708 70318916
Calcium deficiency 26.09 10.19 32 580788 744 70346880
Product label on wrong product 25.99 10.19 9 580811 14 70347610
Bone marrow failure 25.95 10.19 266 580554 48744 70298880
Barrett's oesophagus 25.79 10.19 32 580788 753 70346871
Tetanus 25.74 10.19 12 580808 54 70347570
Type 2 diabetes mellitus 25.55 10.19 234 580586 43846 70303778
Truncus coeliacus thrombosis 25.53 10.19 8 580812 7 70347617
Inflammation 25.41 10.19 472 580348 78193 70269431
Pulmonary malformation 25.37 10.19 17 580803 171 70347453
Hypergastrinaemia 25.29 10.19 17 580803 172 70347452
Drug use disorder 25.16 10.19 18 580802 8133 70339491
Intestinal dilatation 24.96 10.19 57 580763 2243 70345381
Vitamin B12 deficiency 24.91 10.19 106 580714 5866 70341758
Adverse drug reaction 24.87 10.19 298 580522 53046 70294578
Blood chromogranin A increased 24.84 10.19 24 580796 422 70347202
Wrong technique in product usage process 24.82 10.19 404 580416 68294 70279330
Joint range of motion decreased 24.78 10.19 119 580701 25907 70321717
Akathisia 24.69 10.19 39 580781 12254 70335370
Therapeutic response shortened 24.60 10.19 42 580778 12796 70334828
Dissociation 24.57 10.19 72 580748 3304 70344320
Human herpesvirus 6 infection 24.42 10.19 5 580815 4854 70342770
Jejunal ulcer perforation 24.39 10.19 14 580806 104 70347520
Gallbladder injury 24.38 10.19 38 580782 1114 70346510
Hypoglycaemia 24.23 10.19 974 579846 93390 70254234
BK virus infection 24.19 10.19 18 580802 7971 70339653
Long QT syndrome 24.14 10.19 97 580723 5230 70342394
Muscular weakness 24.08 10.19 1374 579446 136962 70210662
Rash macular 23.97 10.19 317 580503 25227 70322397
Clostridium difficile infection 23.97 10.19 449 580371 38367 70309257
Retinitis 23.78 10.19 3 580817 4157 70343467
Agitated depression 23.65 10.19 20 580800 293 70347331
Blood alkaline phosphatase increased 23.54 10.19 637 580183 57884 70289740
Respiratory depression 23.38 10.19 114 580706 24717 70322907
Lung cyst 23.23 10.19 19 580801 265 70347359
Drug eruption 23.18 10.19 209 580611 39287 70308337
Parkinsonism 23.11 10.19 209 580611 15116 70332508
Hypophagia 23.02 10.19 473 580347 41097 70306527
Fear of injection 22.97 10.19 13 580807 6659 70340965
Pneumocystis jirovecii pneumonia 22.94 10.19 148 580672 29934 70317690
Graft versus host disease in gastrointestinal tract 22.85 10.19 10 580810 5934 70341690
Electrocardiogram QRS complex prolonged 22.80 10.19 28 580792 9778 70337846
Polymyositis 22.80 10.19 65 580755 2936 70344688
Bladder cancer 22.79 10.19 69 580751 17173 70330451
Cystitis haemorrhagic 22.79 10.19 22 580798 8571 70339053
Hypergammaglobulinaemia 22.73 10.19 28 580792 654 70346970
Acute interstitial pneumonitis 22.64 10.19 36 580784 1074 70346550
Multiple organ dysfunction syndrome 22.60 10.19 696 580124 107819 70239805
Moraxella test positive 22.53 10.19 8 580812 14 70347610
Tinnitus 22.52 10.19 419 580401 35757 70311867
Nephrosclerosis 22.51 10.19 46 580774 1675 70345949
Haematotoxicity 22.48 10.19 49 580771 13625 70333999
Graft versus host disease in skin 22.40 10.19 9 580811 5621 70342003
Skin necrosis 22.40 10.19 64 580756 16227 70331397
Breast cancer female 22.28 10.19 32 580788 10454 70337170
Discoloured vomit 22.26 10.19 39 580781 1262 70346362
Abdominal tenderness 22.23 10.19 147 580673 9653 70337971
Product packaging confusion 22.22 10.19 17 580803 214 70347410
Knee arthroplasty 22.16 10.19 177 580643 34124 70313500
Cutaneous lupus erythematosus 21.94 10.19 62 580758 2786 70344838
Febrile neutropenia 21.93 10.19 1410 579410 202908 70144716
Lower gastrointestinal haemorrhage 21.81 10.19 200 580620 14520 70333104
Parosmia 21.72 10.19 89 580731 4842 70342782
Ageusia 21.56 10.19 201 580619 14661 70332963
Oesophageal stenosis 21.53 10.19 77 580743 3927 70343697
Systemic infection 21.48 10.19 14 580806 6643 70340981
Diverticulum 21.29 10.19 188 580632 13505 70334119
Miosis 21.20 10.19 53 580767 14048 70333576
Dialysis 21.20 10.19 227 580593 17175 70330449
Rebound acid hypersecretion 21.15 10.19 12 580808 87 70347537
Adjusted calcium decreased 21.14 10.19 16 580804 198 70347426
Osteoarthritis 20.92 10.19 455 580365 73692 70273932
Altered state of consciousness 20.86 10.19 218 580602 39804 70307820
Cholecystectomy 20.84 10.19 130 580690 8367 70339257
Haemoptysis 20.68 10.19 560 580260 50892 70296732
Melaena 20.60 10.19 606 580214 55749 70291875
Oesophageal atresia 20.56 10.19 11 580809 70 70347554
Febrile bone marrow aplasia 20.53 10.19 42 580778 11949 70335675
Occult blood positive 20.27 10.19 105 580715 6308 70341316
Oropharyngeal blistering 20.25 10.19 27 580793 684 70346940
Pulmonary toxicity 20.08 10.19 36 580784 10762 70336862
Pancreatic abscess 19.94 10.19 11 580809 75 70347549
Injection site bruising 19.89 10.19 207 580613 37825 70309799
Viral mutation identified 19.79 10.19 3 580817 3619 70344005
Indifference 19.78 10.19 17 580803 255 70347369
Suspected suicide 19.74 10.19 26 580794 8808 70338816
Lip dry 19.69 10.19 31 580789 9754 70337870
Accidental death 19.69 10.19 4 580816 3904 70343720
Injection site erythema 19.58 10.19 451 580369 72473 70275151
Choluria 19.53 10.19 19 580801 337 70347287
Pneumatosis intestinalis 19.52 10.19 12 580808 5875 70341749
Skin exfoliation 19.47 10.19 529 580291 48097 70299527
Torus fracture 19.47 10.19 11 580809 79 70347545
Sleep disorder due to a general medical condition 19.41 10.19 35 580785 10441 70337183
Tongue blistering 19.40 10.19 38 580782 1341 70346283
Dysphagia 19.30 10.19 1119 579701 111715 70235909
Gastric xanthoma 19.07 10.19 5 580815 0 70347624
Endophthalmitis 19.06 10.19 14 580806 6241 70341383
Cerebral infarction 19.02 10.19 243 580577 42766 70304858
Metastases to lymph nodes 18.85 10.19 29 580791 9209 70338415
Chest discomfort 18.76 10.19 1220 579600 123161 70224463
Cardiotoxicity 18.76 10.19 39 580781 11031 70336593
Cardiac arrest 18.73 10.19 1094 579726 158740 70188884
Cytomegalovirus chorioretinitis 18.71 10.19 10 580810 5288 70342336
Aspergillus infection 18.63 10.19 79 580741 17789 70329835
Colitis ischaemic 18.44 10.19 187 580633 13950 70333674
Mesenteric artery thrombosis 18.38 10.19 23 580797 546 70347078
Acute generalised exanthematous pustulosis 18.36 10.19 200 580620 15197 70332427
Neutrophil count increased 18.33 10.19 315 580505 26480 70321144
Pneumonitis 18.32 10.19 581 580239 54016 70293608
Lung disorder 18.30 10.19 431 580389 69053 70278571
Hepatitis B 18.01 10.19 24 580796 8090 70339534
Transplant dysfunction 17.96 10.19 18 580802 6891 70340733
Restless legs syndrome 17.84 10.19 230 580590 18198 70329426
Duodenitis 17.72 10.19 108 580712 6894 70340730
Alanine aminotransferase abnormal 17.72 10.19 24 580796 8035 70339589
Dislocation of vertebra 17.67 10.19 9 580811 4891 70342733
Blood copper increased 17.66 10.19 7 580813 19 70347605
Urinary tract infection pseudomonal 17.66 10.19 39 580781 1500 70346124
Progressive multifocal leukoencephalopathy 17.63 10.19 89 580731 19125 70328499
Blood pressure diastolic increased 17.54 10.19 48 580772 12343 70335281
Muscle disorder 17.53 10.19 87 580733 5138 70342486
Intestinal ulcer 17.49 10.19 42 580778 1708 70345916
Essential hypertension 17.48 10.19 90 580730 5394 70342230
Personality disorder 17.46 10.19 12 580808 5536 70342088
Ceruloplasmin increased 17.46 10.19 6 580814 9 70347615
Electrocardiogram QT prolonged 17.45 10.19 844 579976 82673 70264951
Hypotension 17.44 10.19 3656 577164 400725 69946899
Electrolyte imbalance 17.38 10.19 313 580507 26548 70321076
Joint stiffness 17.37 10.19 194 580626 34982 70312642
Transplant rejection 17.35 10.19 83 580737 18088 70329536
Skin discolouration 17.28 10.19 414 580406 36911 70310713
Thermohypoaesthesia 17.25 10.19 11 580809 101 70347523
Circulatory collapse 17.20 10.19 396 580424 35078 70312546
Gastrointestinal polyp haemorrhage 17.19 10.19 20 580800 439 70347185
Hand-eye coordination impaired 17.16 10.19 7 580813 21 70347603
Pregnancy with contraceptive device 17.10 10.19 3 580817 3252 70344372
Ectopic gastric mucosa 17.08 10.19 6 580814 10 70347614
Oxygen saturation decreased 17.05 10.19 779 580041 115650 70231974
Carcinoid tumour of the gastrointestinal tract 17.02 10.19 10 580810 78 70347546
Product dose omission issue 16.99 10.19 2032 578788 215436 70132188
Death 16.90 10.19 3808 577012 506253 69841371
Hepatic rupture 16.85 10.19 9 580811 57 70347567
Infective exacerbation of chronic obstructive airways disease 16.81 10.19 52 580768 2459 70345165
Enterococcal infection 16.78 10.19 62 580758 14520 70333104
Fear of eating 16.62 10.19 19 580801 409 70347215
Abnormal weight gain 16.61 10.19 49 580771 2257 70345367
Polyomavirus-associated nephropathy 16.59 10.19 11 580809 5172 70342452
Soft tissue mass 16.56 10.19 31 580789 1057 70346567
Foetal death 16.52 10.19 16 580804 6223 70341401
Metastases to liver 16.50 10.19 134 580686 25744 70321880
Faecal calprotectin increased 16.41 10.19 8 580812 4457 70343167
Adjustment disorder with depressed mood 16.40 10.19 7 580813 4216 70343408
Abdominal distension 16.40 10.19 1030 579790 103639 70243985
Polyuria 16.39 10.19 175 580645 13231 70334393
Vasoplegia syndrome 16.38 10.19 3 580817 3153 70344471
Calcium metabolism disorder 16.24 10.19 9 580811 62 70347562
Malignant spinal cord compression 16.23 10.19 12 580808 143 70347481
Avian influenza 16.22 10.19 10 580810 86 70347538
Sepsis neonatal 16.19 10.19 8 580812 42 70347582
Posterior reversible encephalopathy syndrome 16.19 10.19 125 580695 24277 70323347
Bromhidrosis 16.16 10.19 5 580815 4 70347620
Yellow skin 16.10 10.19 61 580759 3200 70344424
Mesenteric vein thrombosis 15.99 10.19 36 580784 1403 70346221
Malignant mediastinal neoplasm 15.98 10.19 27 580793 848 70346776
Brain scan abnormal 15.94 10.19 32 580788 1150 70346474
Acute psychosis 15.94 10.19 69 580751 3847 70343777
Cholecystitis 15.88 10.19 248 580572 20453 70327171
Prescribed overdose 15.88 10.19 144 580676 27037 70320587
Injection site reaction 15.83 10.19 300 580520 49552 70298072
Endoscopy abnormal 15.75 10.19 8 580812 45 70347579
Respiratory tract malformation 15.66 10.19 10 580810 92 70347532
Pharyngeal oedema 15.66 10.19 197 580623 15499 70332125
Target skin lesion 15.53 10.19 11 580809 122 70347502
Ventricular flutter 15.48 10.19 10 580810 94 70347530
Cerebrovascular accident 15.41 10.19 1370 579450 142100 70205524
Nephroangiosclerosis 15.40 10.19 16 580804 308 70347316
Bursitis 15.28 10.19 142 580678 26531 70321093
Intraductal papillary breast neoplasm 15.25 10.19 4 580816 0 70347624
Latent tetany 15.25 10.19 4 580816 0 70347624
Bronchopulmonary aspergillosis 15.18 10.19 105 580715 20897 70326727
Intestinal metaplasia 15.10 10.19 7 580813 31 70347593
Hyperkalaemia 15.09 10.19 1040 579780 105551 70242073
Oral herpes 15.07 10.19 126 580694 24060 70323564
Burning sensation 15.06 10.19 552 580268 52318 70295306
Product taste abnormal 15.02 10.19 45 580775 2091 70345533
Nocardiosis 14.97 10.19 12 580808 5117 70342507
Joint destruction 14.88 10.19 10 580810 4668 70342956
Ischaemic nephropathy 14.76 10.19 7 580813 33 70347591
Graft versus host disease 14.71 10.19 68 580752 14955 70332669
Immunosuppressant drug level increased 14.68 10.19 113 580707 7794 70339830
Normal newborn 14.64 10.19 18 580802 6282 70341342
Degenerative mitral valve disease 14.63 10.19 14 580806 243 70347381
Depression 14.61 10.19 1852 578968 197122 70150502
Acquired oesophageal web 14.60 10.19 15 580805 285 70347339
Prothrombin level decreased 14.39 10.19 36 580784 1503 70346121
Duodenal stenosis 14.37 10.19 23 580797 690 70346934
Viral diarrhoea 14.34 10.19 16 580804 335 70347289
Liver injury 14.27 10.19 243 580577 40792 70306832
Injection site swelling 14.23 10.19 258 580562 42899 70304725
Herpes zoster 14.22 10.19 562 580258 84673 70262951
Injection site haemorrhage 14.15 10.19 137 580683 25390 70322234
Exposure to toxic agent 14.08 10.19 18 580802 6176 70341448
Pleural thickening 14.06 10.19 3 580817 2829 70344795
Sight disability 14.04 10.19 10 580810 112 70347512
Virologic failure 13.99 10.19 7 580813 3843 70343781
Bleeding time prolonged 13.96 10.19 31 580789 1197 70346427
Obesity 13.88 10.19 146 580674 26625 70320999
Cardio-respiratory arrest 13.87 10.19 678 580142 99999 70247625
Hepatitis B reactivation 13.87 10.19 14 580806 5341 70342283
Skin test positive 13.84 10.19 29 580791 1075 70346549
Alcohol use disorder 13.82 10.19 6 580814 22 70347602
Tongue discomfort 13.79 10.19 45 580775 2190 70345434
Maternal exposure before pregnancy 13.78 10.19 7 580813 3809 70343815
Musculoskeletal pain 13.71 10.19 602 580218 89725 70257899
Back pain 13.69 10.19 2471 578349 268681 70078943
Decreased appetite 13.68 10.19 2761 578059 302019 70045605
Tongue oedema 13.67 10.19 93 580727 6166 70341458
Coronary artery bypass 13.66 10.19 17 580803 5903 70341721
Respiratory tract infection 13.66 10.19 449 580371 41949 70305675
Achlorhydria 13.66 10.19 5 580815 10 70347614
Feeling abnormal 13.64 10.19 1348 579472 140971 70206653
Vasculitic rash 13.60 10.19 42 580778 1984 70345640
Blood parathyroid hormone decreased 13.50 10.19 34 580786 8990 70338634
Hypoosmolar state 13.50 10.19 14 580806 269 70347355
White blood cell count increased 13.48 10.19 698 580122 68875 70278749
Product residue present 13.43 10.19 59 580761 3311 70344313
Superinfection 13.39 10.19 69 580751 4137 70343487
Drug dose titration not performed 13.31 10.19 23 580797 736 70346888
Device issue 13.30 10.19 129 580691 23896 70323728
Product monitoring error 13.23 10.19 98 580722 6678 70340946
Urine calcium decreased 13.23 10.19 6 580814 25 70347599
Hyponatraemic syndrome 13.22 10.19 23 580797 740 70346884
Memory impairment 13.14 10.19 904 579916 91737 70255887
Hepatic haematoma 13.12 10.19 24 580796 804 70346820
Stevens-Johnson syndrome 13.09 10.19 386 580434 35521 70312103
Derailment 13.05 10.19 8 580812 68 70347556
Hair injury 13.05 10.19 5 580815 12 70347612
Antipsychotic drug level decreased 13.01 10.19 28 580792 1058 70346566
Blood creatine phosphokinase increased 12.98 10.19 620 580200 60643 70286981
Gastrointestinal erosion 12.98 10.19 27 580793 996 70346628
Dry skin 12.93 10.19 571 580249 55360 70292264
Retroperitoneal fibrosis 12.91 10.19 20 580800 583 70347041
Subdural haemorrhage 12.91 10.19 83 580737 5398 70342226
Breast cancer 12.89 10.19 195 580625 33354 70314270
Asthma 12.88 10.19 834 579986 119959 70227665
Drop attacks 12.74 10.19 27 580793 1009 70346615
Jaundice cholestatic 12.72 10.19 123 580697 9061 70338563
Intercepted product preparation error 12.71 10.19 3 580817 2639 70344985
Tracheo-oesophageal fistula 12.70 10.19 19 580801 537 70347087
Bone pain 12.68 10.19 523 580297 50299 70297325
Hip fracture 12.63 10.19 312 580508 27951 70319673
Metastases to lung 12.62 10.19 81 580739 16403 70331221
Status epilepticus 12.62 10.19 134 580686 24392 70323232
Sinonasal obstruction 12.61 10.19 13 580807 248 70347376
Gastric antral vascular ectasia 12.51 10.19 24 580796 834 70346790
Lipidosis 12.51 10.19 5 580815 14 70347610
Acute lymphocytic leukaemia recurrent 12.50 10.19 13 580807 4891 70342733
Coronary arterial stent insertion 12.48 10.19 18 580802 5869 70341755
Postictal paralysis 12.45 10.19 15 580805 342 70347282
Paradoxical drug reaction 12.45 10.19 22 580798 6614 70341010
Granuloma annulare 12.44 10.19 19 580801 547 70347077
Polycystic ovaries 12.43 10.19 4 580816 2868 70344756
Gastrointestinal mucosal exfoliation 12.42 10.19 12 580808 211 70347413
Incontinence 12.36 10.19 162 580658 12866 70334758
Hepatitis toxic 12.32 10.19 72 580748 4527 70343097
Stillbirth 12.28 10.19 8 580812 3797 70343827
Occupational exposure to air contaminants 12.26 10.19 10 580810 139 70347485
Second primary malignancy 12.24 10.19 60 580760 12991 70334633
Temperature regulation disorder 12.23 10.19 11 580809 4433 70343191
DNA antibody 12.22 10.19 6 580814 31 70347593
Small intestinal obstruction 12.19 10.19 276 580544 24379 70323245
Gallbladder hypofunction 12.19 10.19 17 580803 450 70347174
Amino acid level increased 12.13 10.19 21 580799 673 70346951
Somatosensory evoked potentials abnormal 12.12 10.19 11 580809 178 70347446
Gallbladder adenocarcinoma 12.12 10.19 9 580811 108 70347516
Drug dose omission by device 12.11 10.19 10 580810 4202 70343422
Cystic fibrosis 12.11 10.19 68 580752 4213 70343411
Oesophageal perforation 12.11 10.19 31 580789 1313 70346311
Food allergy 12.08 10.19 33 580787 8491 70339133
Spinal cord herniation 12.05 10.19 4 580816 5 70347619
Genital blister 12.05 10.19 9 580811 109 70347515
Red blood cell analysis abnormal 12.02 10.19 5 580815 16 70347608
Vertigo positional 12.01 10.19 53 580767 2980 70344644
Dysphonia 11.92 10.19 513 580307 49587 70298037
Helicobacter test positive 11.91 10.19 29 580791 1190 70346434
Venoocclusive liver disease 11.90 10.19 46 580774 10632 70336992
Hypocalcaemic seizure 11.87 10.19 7 580813 55 70347569
Fibrinolysis 11.87 10.19 7 580813 55 70347569
Deformity 11.85 10.19 32 580788 8265 70339359
Cerebral haematoma 11.84 10.19 102 580718 7276 70340348
Liver disorder 11.83 10.19 399 580421 61169 70286455
Haemodialysis 11.82 10.19 204 580616 17162 70330462
Blood urea increased 11.81 10.19 474 580346 45435 70302189
Hepatitis acute 11.77 10.19 170 580650 13792 70333832
Therapeutic product ineffective 11.73 10.19 35 580785 1622 70346002
Lung opacity 11.72 10.19 8 580812 3705 70343919
Mycobacterial infection 11.72 10.19 7 580813 3481 70344143
Retching 11.72 10.19 190 580630 15789 70331835
Eczema eyelids 11.69 10.19 10 580810 149 70347475
Sensory loss 11.68 10.19 144 580676 11275 70336349
Faecaloma 11.67 10.19 134 580686 10317 70337307
Blood 1,25-dihydroxycholecalciferol decreased 11.58 10.19 5 580815 18 70347606
Blood electrolytes decreased 11.58 10.19 30 580790 1280 70346344
Petechiae 11.57 10.19 221 580599 18951 70328673
Hepatocellular injury 11.56 10.19 288 580532 45803 70301821
Borderline personality disorder 11.53 10.19 23 580797 823 70346801
Abdominal sepsis 11.50 10.19 39 580781 1936 70345688
Prevertebral soft tissue swelling of cervical space 11.50 10.19 6 580814 36 70347588
Sweat discolouration 11.50 10.19 6 580814 36 70347588
Eyelid retraction 11.50 10.19 6 580814 36 70347588
Reaction to excipient 11.49 10.19 32 580788 1426 70346198
Oedema peripheral 11.45 10.19 2078 578742 226013 70121611
Non-small cell lung cancer stage III 11.44 10.19 3 580817 0 70347624
Nephrostomy tube removal 11.44 10.19 3 580817 0 70347624
Carotid pulse abnormal 11.44 10.19 3 580817 0 70347624
Multiple endocrine neoplasia Type 1 11.44 10.19 3 580817 0 70347624
Stertor 11.44 10.19 3 580817 0 70347624
Anal chlamydia infection 11.44 10.19 3 580817 0 70347624
Vertigo labyrinthine 11.44 10.19 3 580817 0 70347624
Gastroenteritis eosinophilic 11.43 10.19 12 580808 234 70347390
Multiple drug therapy 11.32 10.19 54 580766 3138 70344486
Portal vein thrombosis 11.31 10.19 79 580741 5283 70342341
Full blood count decreased 11.29 10.19 266 580554 23652 70323972
Ankylosing spondylitis 11.23 10.19 53 580767 11593 70336031
Injection site pruritus 11.23 10.19 240 580580 38970 70308654
Incorrect route of product administration 11.23 10.19 151 580669 26341 70321283
Device malfunction 11.19 10.19 101 580719 18983 70328641
Malabsorption 11.17 10.19 71 580749 4599 70343025
Odynophagia 11.15 10.19 130 580690 10045 70337579
Renal hypertension 11.13 10.19 11 580809 199 70347425
Urine output increased 11.13 10.19 38 580782 1893 70345731
Alcohol interaction 11.12 10.19 13 580807 4640 70342984
Deep vein thrombosis postoperative 11.09 10.19 8 580812 3599 70344025
COVID-19 treatment 11.07 10.19 16 580804 438 70347186
Injection site warmth 11.07 10.19 67 580753 13758 70333866
Laryngeal discomfort 11.03 10.19 18 580802 549 70347075
Mitochondrial toxicity 11.02 10.19 5 580815 2905 70344719
Epistaxis 11.02 10.19 980 579840 101647 70245977
Radiation inflammation 11.01 10.19 18 580802 550 70347074
Nightmare 10.95 10.19 248 580572 21908 70325716
Acute respiratory failure 10.93 10.19 541 580279 53124 70294500
Finger deformity 10.93 10.19 21 580799 6115 70341509
Urticaria vesiculosa 10.92 10.19 4 580816 8 70347616
Supraventricular tachycardia 10.82 10.19 224 580596 19486 70328138
Lactation disorder 10.79 10.19 11 580809 207 70347417
Drug dispensed to wrong patient 10.78 10.19 18 580802 560 70347064
Pharyngeal swelling 10.77 10.19 90 580730 6363 70341261
Oesophageal adenocarcinoma 10.77 10.19 22 580798 801 70346823
Cerebral artery thrombosis 10.76 10.19 26 580794 1062 70346562
Product odour abnormal 10.69 10.19 28 580792 1203 70346421
No adverse event 10.67 10.19 192 580628 31961 70315663
Plethoric face 10.64 10.19 5 580815 23 70347601
Gastrinoma 10.64 10.19 5 580815 23 70347601
Product substitution error 10.63 10.19 6 580814 43 70347581
Intestinal fistula infection 10.61 10.19 4 580816 9 70347615
Amylase increased 10.56 10.19 129 580691 10079 70337545
Drug dependence 10.53 10.19 229 580591 37092 70310532
Superior mesenteric artery syndrome 10.53 10.19 10 580810 172 70347452
Magnesium metabolism disorder 10.52 10.19 6 580814 44 70347580
Cardiac steatosis 10.52 10.19 6 580814 44 70347580
Urine chloride decreased 10.50 10.19 8 580812 100 70347524
Aphonia 10.50 10.19 119 580701 9132 70338492
Hypercreatininaemia 10.48 10.19 22 580798 817 70346807
Gastroenteritis aeromonas 10.47 10.19 5 580815 24 70347600
Gastroenteritis 10.43 10.19 332 580488 30881 70316743
Varicella zoster virus infection 10.41 10.19 11 580809 4109 70343515
Eosinophilic fasciitis 10.40 10.19 12 580808 261 70347363
Pleural mass 10.40 10.19 7 580813 71 70347553
Device dislocation 10.39 10.19 126 580694 22381 70325243
Uveitis 10.34 10.19 75 580745 14770 70332854
Premature rupture of membranes 10.31 10.19 10 580810 3888 70343736
Vulvar basal cell carcinoma 10.31 10.19 5 580815 25 70347599
Diffuse large B-cell lymphoma recurrent 10.31 10.19 8 580812 3468 70344156
Pneumonia streptococcal 10.30 10.19 44 580776 2439 70345185
Claustrophobia 10.26 10.19 23 580797 894 70346730
Peptic ulcer 10.25 10.19 81 580739 5632 70341992
Mastication disorder 10.21 10.19 44 580776 2448 70345176
Poliomyelitis 10.19 10.19 6 580814 47 70347577

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BC01 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
Proton pump inhibitors
ATC A02BD01 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 A02BD05 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 A02BD16 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
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

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

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
Reduction of risk of upper gastrointestinal bleeding indication 37372002
Erosive esophagitis indication 40719004
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Peptic reflux disease indication 57643001
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Erosive Esophagitis indication
Pathological Gastric Hypersecretory Condition indication
Gastric Hypersecretory Conditions indication
Upper gastrointestinal hemorrhage off-label use 37372002
Chronic heart failure contraindication 48447003
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Osteoporosis contraindication 64859006 DOID:11476
Oliguria contraindication 83128009
Atrophic gastritis contraindication 84568007 DOID:8929
Fracture of bone contraindication 125605004
Hypomagnesemia contraindication 190855004
Disease of liver contraindication 235856003 DOID:409
Edema contraindication 267038008




🐶 Veterinary Drug Use

SpeciesUseRelation
Horses Gastric ulcers Indication

🐶 Veterinary products

ProductApplicantIngredients
GastroGard Boehringer lngelheim Animal Health USA Inc. 1
UlcerGard Boehringer lngelheim Animal Health USA Inc. 1

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
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9364439 May 31, 2022 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9364439 May 31, 2022 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 8206741 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 6926907 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 8206741 Feb. 28, 2023 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9987231 Jan. 2, 2033 FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9987231 Jan. 2, 2033 FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS
325MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9539214 March 13, 2033 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
81MG;40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 DISCN TABLET, DELAYED RELEASE ORAL 9539214 March 13, 2033 TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 11135172 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9050263 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9498445 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
250MG;EQ 10MG BASE;12.5MG TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9603806 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Potassium-transporting ATPase Transporter INHIBITOR IC50 5.70 CHEMBL CHEMBL
Multidrug resistance protein 1 Transporter IC50 4.05 WOMBAT-PK
Cytochrome P450 2C9 Enzyme Ki 4.35 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 4.74 WOMBAT-PK
Cytochrome P450 2C19 Enzyme Ki 5.30 WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.47 CHEMBL
N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 Enzyme IC50 4.70 CHEMBL
Glutathione S-transferase omega-1 Unclassified IC50 5.34 CHEMBL
Cytosolic endo-beta-N-acetylglucosaminidase Enzyme IC50 4.60 CHEMBL
Cytochrome P450 3A4 Enzyme Km 4.31 WOMBAT-PK
Potassium-transporting ATPase Enzyme IC50 5.42 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6.16 SCIENTIFIC LITERATURE

External reference:

IDSource
4019439 VUID
N0000147569 NUI
D00455 KEGG_DRUG
95510-70-6 SECONDARY_CAS_RN
95382-33-5 SECONDARY_CAS_RN
4019439 VANDF
4025702 VANDF
4029343 VANDF
C0028978 UMLSCUI
CHEBI:7772 CHEBI
1C6 PDB_CHEM_ID
CHEMBL1503 ChEMBL_ID
CHEMBL2105294 ChEMBL_ID
DB00338 DRUGBANK_ID
CHEMBL1567328 ChEMBL_ID
D009853 MESH_DESCRIPTOR_UI
4594 PUBCHEM_CID
4279 IUPHAR_LIGAND_ID
5081 INN_ID
KG60484QX9 UNII
1792108 RXNORM
174165 MMSL
34509 MMSL
38031 MMSL
45807 MMSL
5201 MMSL
d00325 MMSL
d05770 MMSL
003476 NDDF
005065 NDDF
006090 NDDF
25673006 SNOMEDCT_US
384973006 SNOMEDCT_US
387137007 SNOMEDCT_US
420878004 SNOMEDCT_US
441570004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Good Sense Omeprazole and Sodium Bicarbonate HUMAN OTC DRUG LABEL 2 0113-0058 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
good sense omeprazole HUMAN OTC DRUG LABEL 1 0113-0520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-1723 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
good sense omeprazole delayed release HUMAN OTC DRUG LABEL 1 0113-1803 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7401 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
basic care omeprazole HUMAN OTC DRUG LABEL 1 0113-7520 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Basic Care Omeprazole HUMAN OTC DRUG LABEL 1 0113-7915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0007 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole Magnesium HUMAN OTC DRUG LABEL 1 0363-0042 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
Omeprazole and sodium bicarbonate HUMAN OTC DRUG LABEL 2 0363-0732 CAPSULE, GELATIN COATED 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-0915 TABLET, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Acid Reducer Human OTC Drug Label 1 0363-1008 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-1607 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-1819 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-9980 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Acid Reducer Human OTC Drug Label 1 0536-1322 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 16 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-1359 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 27 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8320 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8406 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8406 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2234 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2234 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2785 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2785 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2790 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2790 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 28 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2859 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 28 sections