omeprazole 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: 2.57
  • 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 ┬ÁM/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
Chronic kidney disease 2563.01 23.37 547 7465 3571 2346502
Hypomagnesaemia 1881.94 23.37 391 7621 2173 2347900
Acute kidney injury 1579.76 23.37 562 7450 27560 2322513
Hyponatraemia 1433.37 23.37 436 7576 12889 2337184
Tubulointerstitial nephritis 1288.76 23.37 284 7728 2154 2347919
Drug interaction 1137.72 23.37 447 7565 28716 2321357
Renal injury 940.01 23.37 187 7825 790 2349283
Hypocalcaemia 897.99 23.37 232 7780 3651 2346422
Completed suicide 771.17 23.37 309 7703 20725 2329348
Toxicity to various agents 621.42 23.37 303 7709 32451 2317622
End stage renal disease 618.06 23.37 117 7895 354 2349719
Gastrooesophageal reflux disease 588.09 23.37 203 7809 8892 2341181
Hypokalaemia 549.23 23.37 201 7811 10453 2339620
Diarrhoea 498.06 23.37 366 7646 83198 2266875
Renal failure 496.73 23.37 214 7798 17135 2332938
Confusional state 472.32 23.37 229 7783 24115 2325958
Vomiting 426.81 23.37 314 7698 71288 2278785
Subacute cutaneous lupus erythematosus 402.95 23.37 80 7932 331 2349742
Nausea 387.36 23.37 358 7654 111831 2238242
Drug ineffective 373.47 23.37 336 7676 101288 2248785
Fall 362.70 23.37 242 7770 46857 2303216
Drug hypersensitivity 352.74 23.37 237 7775 46406 2303667
Electrocardiogram QT prolonged 335.17 23.37 129 7883 7685 2342388
Abdominal pain 322.09 23.37 200 7812 34174 2315899
Dizziness 319.24 23.37 244 7768 58421 2291652
Tetany 307.61 23.37 66 7946 428 2349645
Toxic epidermal necrolysis 298.68 23.37 94 7918 3050 2347023
Hypotension 284.35 23.37 181 7831 32255 2317818
Abdominal pain upper 276.12 23.37 155 7857 21945 2328128
Dyspepsia 269.99 23.37 118 7894 9726 2340347
Malaise 269.30 23.37 216 7796 55369 2294704
Dyspnoea 245.19 23.37 238 7774 78495 2271578
Intentional overdose 238.70 23.37 113 7899 11208 2338865
Pancytopenia 219.26 23.37 107 7905 11345 2338728
Pruritus 215.11 23.37 171 7841 43169 2306904
Somnolence 212.92 23.37 134 7878 23351 2326722
Rash 200.18 23.37 188 7824 59370 2290703
Inappropriate antidiuretic hormone secretion 198.47 23.37 64 7948 2245 2347828
Exposure during pregnancy 194.46 23.37 130 7882 25089 2324984
Hepatocellular injury 191.93 23.37 72 7940 3983 2346090
Product complaint 187.59 23.37 73 7939 4465 2345608
Fatigue 186.16 23.37 213 7799 84660 2265413
Lethargy 183.52 23.37 87 7925 8643 2341430
Asthenia 182.77 23.37 161 7851 46765 2303308
Thrombocytopenia 180.48 23.37 112 7900 19019 2331054
Muscle spasms 180.39 23.37 117 7895 21449 2328624
Pyrexia 175.51 23.37 167 7845 53541 2296532
Mucosal inflammation 174.23 23.37 72 7940 5152 2344921
Liver function test abnormal 174.01 23.37 80 7932 7410 2342663
Decreased appetite 171.69 23.37 127 7885 28764 2321309
Paraesthesia 170.56 23.37 114 7898 21974 2328099
Suicide attempt 168.03 23.37 89 7923 11193 2338880
Dilatation intrahepatic duct acquired 167.79 23.37 30 7982 58 2350015
Syncope 167.32 23.37 102 7910 16773 2333300
Seizure 166.97 23.37 117 7895 24349 2325724
Condition aggravated 166.71 23.37 130 7882 31849 2318224
Depression 165.66 23.37 123 7889 28009 2322064
Type I hypersensitivity 161.30 23.37 40 7972 522 2349551
Product substitution issue 159.40 23.37 67 7945 5002 2345071
Dehydration 157.69 23.37 109 7903 22186 2327887
Therapeutic product cross-reactivity 155.58 23.37 36 7976 342 2349731
Drug reaction with eosinophilia and systemic symptoms 153.93 23.37 67 7945 5451 2344622
Headache 152.13 23.37 187 7825 79992 2270081
Anxiety 147.90 23.37 117 7895 29242 2320831
Tachycardia 144.50 23.37 92 7920 16317 2333756
Tremor 134.41 23.37 96 7916 20565 2329508
Stevens-Johnson syndrome 132.91 23.37 56 7956 4203 2345870
Hypoparathyroidism 130.98 23.37 26 7986 107 2349966
Blood sodium decreased 128.54 23.37 50 7962 3050 2347023
Clostridium difficile infection 128.35 23.37 49 7963 2841 2347232
Arthralgia 126.77 23.37 141 7871 54144 2295929
Metabolic alkalosis 125.74 23.37 30 7982 329 2349744
Abdominal distension 124.30 23.37 71 7941 10340 2339733
Disorientation 123.23 23.37 60 7952 6312 2343761
Treatment noncompliance 121.93 23.37 57 7955 5477 2344596
Cardio-respiratory arrest 121.76 23.37 67 7945 9079 2340994
Cutaneous lupus erythematosus 118.97 23.37 32 7980 585 2349488
Dry mouth 116.91 23.37 63 7949 8190 2341883
Haematemesis 111.98 23.37 49 7963 4033 2346040
Rhabdomyolysis 111.54 23.37 57 7955 6647 2343426
Torsade de pointes 110.32 23.37 41 7971 2205 2347868
Cholestasis 109.71 23.37 47 7965 3674 2346399
Weight decreased 109.53 23.37 97 7915 28274 2321799
Foetal exposure during pregnancy 109.26 23.37 52 7960 5200 2344873
Hypertension 108.53 23.37 95 7917 27266 2322807
Dysphagia 108.24 23.37 70 7942 12735 2337338
Urticaria 107.98 23.37 90 7922 24171 2325902
Hyperkalaemia 106.52 23.37 53 7959 5840 2344233
Hepatotoxicity 106.04 23.37 45 7967 3436 2346637
Hepatitis 105.78 23.37 54 7958 6283 2343790
Insomnia 105.22 23.37 91 7921 25696 2324377
Muscular weakness 103.28 23.37 72 7940 14825 2335248
Alanine aminotransferase increased 102.41 23.37 70 7942 13962 2336111
Sepsis 102.40 23.37 78 7934 18410 2331663
Chest pain 102.28 23.37 93 7919 28044 2322029
Jaundice 100.93 23.37 50 7962 5458 2344615
Agitation 99.82 23.37 63 7949 10988 2339085
Angioedema 99.50 23.37 57 7955 8339 2341734
Pancreatitis acute 98.44 23.37 44 7968 3809 2346264
Abdominal tenderness 98.08 23.37 31 7981 1016 2349057
Constipation 95.74 23.37 80 7932 21549 2328524
Maternal exposure during pregnancy 91.88 23.37 67 7945 14796 2335277
Orthostatic hypotension 90.29 23.37 38 7974 2841 2347232
Atrial fibrillation 89.53 23.37 64 7948 13704 2336369
Cough 89.44 23.37 93 7919 33024 2317049
Developmental hip dysplasia 88.51 23.37 20 7992 169 2349904
Renal impairment 87.32 23.37 56 7956 10036 2340037
Erythema 85.28 23.37 80 7932 25079 2324994
Neutropenia 83.76 23.37 74 7938 21474 2328599
Anaemia 82.15 23.37 91 7921 34701 2315372
Oesophagitis 81.89 23.37 32 7980 1974 2348099
Face oedema 81.83 23.37 39 7973 3909 2346164
Skin test positive 80.59 23.37 19 7993 197 2349876
Nasal polyps 80.59 23.37 19 7993 197 2349876
Loss of consciousness 78.07 23.37 67 7945 18700 2331373
Intentional self-injury 77.19 23.37 38 7974 4089 2345984
Vision blurred 77.07 23.37 60 7952 14608 2335465
Swollen tongue 76.23 23.37 41 7971 5302 2344771
Hypoglycaemia 76.08 23.37 48 7964 8359 2341714
Contusion 75.23 23.37 56 7956 12754 2337319
Gait disturbance 75.08 23.37 71 7941 22474 2327599
Schizophrenia 74.86 23.37 27 7985 1332 2348741
Anaphylactic reaction 74.56 23.37 50 7962 9655 2340418
Metabolic acidosis 74.50 23.37 42 7970 5956 2344117
Flatulence 73.88 23.37 38 7974 4487 2345586
Blood bilirubin increased 73.43 23.37 40 7972 5305 2344768
Congenital thrombocytopenia 73.34 23.37 11 8001 0 2350073
Death 73.03 23.37 134 7878 81334 2268739
Blood calcium decreased 72.77 23.37 30 7982 2128 2347945
Aspirin-exacerbated respiratory disease 71.87 23.37 17 7995 179 2349894
Circulatory collapse 71.81 23.37 35 7977 3685 2346388
Hepatitis acute 71.65 23.37 27 7985 1508 2348565
Intentional product misuse 70.77 23.37 48 7964 9441 2340632
Urinary tract infection 68.39 23.37 77 7935 29865 2320208
Cardiac arrest 67.64 23.37 56 7956 14874 2335199
Pain 67.47 23.37 111 7901 61746 2288327
Muscle rigidity 67.03 23.37 27 7985 1804 2348269
Overdose 66.86 23.37 63 7949 19844 2330229
Respiratory distress 66.65 23.37 37 7975 5092 2344981
Vertigo 66.51 23.37 46 7966 9338 2340735
Acute generalised exanthematous pustulosis 66.10 23.37 26 7986 1632 2348441
Hyperhidrosis 66.05 23.37 56 7956 15366 2334707
Hypophosphataemia 65.53 23.37 23 7989 1047 2349026
Asthma 65.40 23.37 49 7963 11265 2338808
Gastritis 64.92 23.37 35 7977 4546 2345527
Palpitations 64.90 23.37 57 7955 16399 2333674
Rebound acid hypersecretion 64.85 23.37 10 8002 2 2350071
Accidental overdose 63.81 23.37 33 7979 3939 2346134
Drug dispensed to wrong patient 63.64 23.37 12 8000 35 2350038
Laryngeal stenosis 62.92 23.37 13 7999 68 2350005
Balance disorder 62.63 23.37 45 7967 9702 2340371
Myalgia 62.00 23.37 65 7947 23268 2326805
Agranulocytosis 61.97 23.37 31 7981 3451 2346622
Venoocclusive liver disease 61.11 23.37 19 7993 589 2349484
Product packaging confusion 60.92 23.37 12 8000 47 2350026
Drug abuse 60.58 23.37 48 7964 11978 2338095
Eosinophilia 60.51 23.37 29 7983 2941 2347132
Hiatus hernia 60.35 23.37 26 7986 2058 2348015
Hallucination 60.24 23.37 41 7971 8107 2341966
Drug-induced liver injury 60.20 23.37 31 7981 3668 2346405
Haemoglobin decreased 60.10 23.37 57 7955 18094 2331979
Prescription drug used without a prescription 59.49 23.37 15 7997 210 2349863
Oedema peripheral 59.25 23.37 64 7948 23699 2326374
Psychotic disorder 58.74 23.37 33 7979 4646 2345427
Mouth ulceration 58.56 23.37 31 7981 3881 2346192
Pneumonia 58.56 23.37 92 7920 49204 2300869
Pain in extremity 58.49 23.37 85 7927 42455 2307618
Social avoidant behaviour 58.43 23.37 18 7994 541 2349532
Premature baby 58.42 23.37 29 7983 3175 2346898
Gastrointestinal sounds abnormal 57.93 23.37 18 7994 557 2349516
Disturbance in attention 57.88 23.37 35 7977 5650 2344423
Limb reduction defect 57.42 23.37 12 8000 67 2350006
Labelled drug-drug interaction medication error 57.42 23.37 22 7990 1286 2348787
Cognitive disorder 57.04 23.37 34 7978 5347 2344726
Rectal haemorrhage 56.92 23.37 35 7977 5821 2344252
Colitis microscopic 56.87 23.37 20 7992 916 2349157
Rash erythematous 56.27 23.37 35 7977 5941 2344132
Hypersensitivity 56.13 23.37 62 7950 23531 2326542
Product use issue 55.85 23.37 46 7966 12123 2337950
Limb hypoplasia congenital 55.69 23.37 10 8002 20 2350053
Hyperventilation 55.13 23.37 21 7991 1208 2348865
Lipase increased 55.04 23.37 22 7990 1440 2348633
Bradycardia 54.96 23.37 42 7970 9939 2340134
Dermatitis exfoliative 54.93 23.37 21 7991 1220 2348853
Abnormal loss of weight 54.83 23.37 18 7994 667 2349406
Skin exfoliation 54.74 23.37 34 7978 5756 2344317
Lupus-like syndrome 54.65 23.37 24 7988 1990 2348083
Wheezing 54.15 23.37 35 7977 6349 2343724
Hyperreflexia 53.78 23.37 19 7993 882 2349191
Pancreatitis 53.51 23.37 38 7974 8041 2342032
Myoclonus 52.89 23.37 25 7987 2458 2347615
Dysgeusia 51.94 23.37 38 7974 8421 2341652
Urinary retention 51.91 23.37 28 7984 3639 2346434
Mucosal dryness 51.90 23.37 15 7997 360 2349713
Transaminases increased 51.28 23.37 30 7982 4557 2345516
Gamma-glutamyltransferase increased 50.92 23.37 32 7980 5530 2344543
Clostridium difficile colitis 50.73 23.37 23 7989 2056 2348017
Congenital oral malformation 50.12 23.37 9 8003 18 2350055
Mental status changes postoperative 50.12 23.37 9 8003 18 2350055
Serotonin syndrome 50.03 23.37 27 7985 3513 2346560
Confusion postoperative 49.48 23.37 9 8003 20 2350053
Symmetrical drug-related intertriginous and flexural exanthema 49.47 23.37 10 8002 46 2350027
Osteopenia 49.10 23.37 22 7990 1913 2348160
Insulin autoimmune syndrome 48.60 23.37 9 8003 23 2350050
Gastric polyps 48.56 23.37 14 7998 333 2349740
Blood alkaline phosphatase increased 48.53 23.37 33 7979 6512 2343561
Hypergammaglobulinaemia 48.36 23.37 11 8001 96 2349977
Medication error 48.07 23.37 32 7980 6099 2343974
Fracture 47.67 23.37 24 7988 2707 2347366
Pre-eclampsia 47.65 23.37 20 7992 1484 2348589
Incorrect dose administered 47.33 23.37 38 7974 9657 2340416
Aspiration 47.26 23.37 20 7992 1514 2348559
Non-Hodgkin's lymphoma recurrent 47.24 23.37 10 8002 60 2350013
Chest discomfort 46.72 23.37 45 7967 14550 2335523
Hepatic necrosis 46.34 23.37 18 7994 1092 2348981
Chronic obstructive pulmonary disease 46.20 23.37 33 7979 7044 2343029
Chills 46.14 23.37 46 7966 15506 2334567
Psychotic symptom 46.04 23.37 12 8000 193 2349880
Full blood count abnormal 45.26 23.37 13 7999 305 2349768
Lip swelling 44.79 23.37 28 7984 4793 2345280
Chromaturia 44.58 23.37 23 7989 2730 2347343
Dermatitis bullous 44.32 23.37 19 7993 1485 2348588
Cyanosis 44.19 23.37 24 7988 3161 2346912
Otitis media 44.12 23.37 15 7997 620 2349453
Poisoning 44.06 23.37 23 7989 2797 2347276
Nephrogenic anaemia 43.82 23.37 11 8001 151 2349922
Breast enlargement 43.21 23.37 13 7999 360 2349713
Sedation 42.98 23.37 24 7988 3338 2346735
Inflammation 42.94 23.37 30 7982 6183 2343890
International normalised ratio increased 42.89 23.37 32 7980 7304 2342769
Acute hepatic failure 42.58 23.37 22 7990 2620 2347453
Eosinophil count increased 42.47 23.37 17 7995 1117 2348956
Moraxella test positive 42.34 23.37 7 8005 6 2350067
Osteoarthritis 42.18 23.37 31 7981 6915 2343158
Rash pruritic 42.12 23.37 32 7980 7503 2342570
Pseudomembranous colitis 42.10 23.37 14 7998 540 2349533
Palatal oedema 42.08 23.37 11 8001 179 2349894
Panic attack 41.93 23.37 25 7987 3931 2346142
Abdominal discomfort 41.72 23.37 46 7966 17410 2332663
Blood disorder 41.61 23.37 16 7996 944 2349129
Hypertensive cardiomyopathy 41.32 23.37 9 8003 63 2350010
Hepatic function abnormal 41.14 23.37 29 7983 6063 2344010
Aspartate aminotransferase increased 40.58 23.37 39 7973 12573 2337500
Superior mesenteric artery syndrome 40.48 23.37 8 8004 32 2350041
C-reactive protein increased 40.45 23.37 29 7983 6226 2343847
Mydriasis 40.20 23.37 20 7992 2199 2347874
Neck deformity 40.15 23.37 9 8003 73 2350000
Blood magnesium decreased 40.07 23.37 17 7995 1295 2348778
Dyskinesia 39.98 23.37 26 7986 4763 2345310
Therapeutic product effect decreased 39.79 23.37 36 7976 10753 2339320
Cleft palate 39.63 23.37 11 8001 227 2349846
Hyperglycaemia 39.51 23.37 26 7986 4859 2345214
Sleep disorder 39.49 23.37 29 7983 6460 2343613
Skin discolouration 39.40 23.37 27 7985 5393 2344680
Vasculitis 39.37 23.37 20 7992 2298 2347775
Urinary tract infection bacterial 39.18 23.37 13 7999 498 2349575
Bicytopenia 39.05 23.37 11 8001 240 2349833
Norovirus test positive 39.02 23.37 8 8004 40 2350033
Intestinal dilatation 38.79 23.37 11 8001 246 2349827
Eructation 38.65 23.37 16 7996 1146 2348927
Premature delivery 38.62 23.37 22 7990 3178 2346895
Melaena 38.53 23.37 24 7988 4082 2345991
Respiratory arrest 38.48 23.37 28 7984 6150 2343923
Thermohypoaesthesia 38.35 23.37 7 8005 16 2350057
Venoocclusive disease 38.34 23.37 11 8001 257 2349816
Stress cardiomyopathy 38.31 23.37 17 7995 1444 2348629
Renal haemangioma 38.28 23.37 6 8006 2 2350071
Iron deficiency anaemia 38.27 23.37 19 7993 2080 2347993
Feeling abnormal 38.16 23.37 51 7961 23530 2326543
Sepsis neonatal 38.11 23.37 9 8003 94 2349979
Depressed mood 38.04 23.37 26 7986 5172 2344901
Pallor 37.99 23.37 23 7989 3719 2346354
Systemic lupus erythematosus 37.92 23.37 24 7988 4197 2345876
Dysmorphism 37.85 23.37 12 8000 397 2349676
Talipes 37.59 23.37 11 8001 276 2349797
Blood potassium decreased 37.56 23.37 26 7986 5279 2344794
Leukopenia 37.56 23.37 34 7978 10162 2339911
Hallucination, visual 37.35 23.37 21 7991 2958 2347115
Septic shock 37.33 23.37 29 7983 7025 2343048
Ventricular tachycardia 37.15 23.37 21 7991 2990 2347083
Thoracic vertebral fracture 37.07 23.37 13 7999 590 2349483
Atrial septal defect 36.41 23.37 16 7996 1328 2348745
Mental status changes 36.37 23.37 26 7986 5556 2344517
Chronic kidney disease-mineral and bone disorder 36.26 23.37 7 8005 24 2350049
Hypoaesthesia 36.26 23.37 46 7966 20169 2329904
Blood creatine phosphokinase increased 35.96 23.37 25 7987 5111 2344962
Nightmare 35.68 23.37 22 7990 3675 2346398
Patent ductus arteriosus 35.66 23.37 13 7999 661 2349412
Gastric disorder 35.61 23.37 22 7990 3688 2346385
Oedema 35.59 23.37 33 7979 10170 2339903
Mania 35.57 23.37 19 7993 2421 2347652
Gastric pH decreased 35.36 23.37 8 8004 68 2350005
Off label use 34.98 23.37 94 7918 73504 2276569
White blood cell count abnormal 34.91 23.37 13 7999 702 2349371
Cogwheel rigidity 34.79 23.37 10 8002 235 2349838
Blood creatinine increased 34.69 23.37 33 7979 10500 2339573
Tachypnoea 34.31 23.37 18 7994 2211 2347862
Leukocytosis 33.80 23.37 21 7991 3555 2346518
Hyperlactacidaemia 33.75 23.37 11 8001 398 2349675
Haematoma 33.70 23.37 24 7988 5097 2344976
Mobility decreased 33.68 23.37 30 7982 8780 2341293
Ovarian germ cell cancer stage II 33.33 23.37 5 8007 0 2350073
Drug level increased 33.20 23.37 19 7993 2768 2347305
Hallucinations, mixed 33.20 23.37 12 8000 595 2349478
Flushing 33.17 23.37 34 7978 11837 2338236
Respiratory acidosis 33.16 23.37 13 7999 808 2349265
Hip fracture 33.14 23.37 23 7989 4689 2345384
Speech disorder 32.96 23.37 26 7986 6438 2343635
Abnormal weight gain 32.96 23.37 10 8002 285 2349788
Electrolyte imbalance 32.93 23.37 17 7995 2020 2348053
Jaundice cholestatic 32.90 23.37 12 8000 611 2349462
Leukocyturia 32.83 23.37 9 8003 177 2349896
Neutrophil count abnormal 32.79 23.37 11 8001 436 2349637
Tongue oedema 32.72 23.37 13 7999 837 2349236
Forceps delivery 32.65 23.37 7 8005 45 2350028
Neuroleptic malignant syndrome 32.60 23.37 17 7995 2063 2348010
Transient ischaemic attack 32.56 23.37 25 7987 5953 2344120
Barrett's oesophagus 32.38 23.37 10 8002 303 2349770
Arrhythmia 32.37 23.37 25 7987 6003 2344070
Viral diarrhoea 32.26 23.37 7 8005 48 2350025
Anal incontinence 32.18 23.37 16 7996 1756 2348317
Nystagmus 32.10 23.37 14 7998 1141 2348932
Hypernatraemia 32.09 23.37 13 7999 881 2349192
Dysuria 31.93 23.37 21 7991 3920 2346153
Aplasia 31.87 23.37 11 8001 476 2349597
Gastrointestinal haemorrhage 31.86 23.37 34 7978 12401 2337672
Lung disorder 31.71 23.37 25 7987 6187 2343886
Aquagenic pruritus 31.65 23.37 5 8007 2 2350071
Visual impairment 31.64 23.37 33 7979 11722 2338351
Toxic skin eruption 31.27 23.37 17 7995 2243 2347830
Hyperaesthesia 31.11 23.37 14 7998 1229 2348844
Neutrophilia 31.02 23.37 11 8001 516 2349557
Pemphigoid 30.91 23.37 13 7999 969 2349104
White blood cell count increased 30.89 23.37 26 7986 7052 2343021
Thinking abnormal 30.80 23.37 16 7996 1926 2348147
Eczema 30.74 23.37 19 7993 3186 2346887
Swelling 30.58 23.37 38 7974 16312 2333761
Sight disability 30.56 23.37 6 8006 23 2350050
Pelvic deformity 30.56 23.37 6 8006 23 2350050
Aggression 30.51 23.37 22 7990 4764 2345309
Blood chromogranin A increased 30.48 23.37 7 8005 64 2350009
Treatment failure 30.38 23.37 26 7986 7213 2342860
Anaphylactic shock 30.33 23.37 21 7991 4265 2345808
Hyperchlorhydria 30.31 23.37 9 8003 238 2349835
Acute respiratory distress syndrome 30.27 23.37 19 7993 3273 2346800
Presyncope 30.17 23.37 20 7992 3783 2346290
H1N1 influenza 30.16 23.37 9 8003 242 2349831
Depersonalisation/derealisation disorder 30.09 23.37 9 8003 244 2349829
Hypotonia 29.60 23.37 15 7997 1715 2348358
Back pain 29.42 23.37 53 7959 31606 2318467
Drug intolerance 29.12 23.37 34 7978 13683 2336390
Coma 29.12 23.37 28 7984 9028 2341045
Cardiac failure 29.11 23.37 32 7980 12062 2338011
Hypoaesthesia oral 29.02 23.37 16 7996 2170 2347903
Hyperparathyroidism secondary 29.01 23.37 8 8004 161 2349912
Mastication disorder 28.99 23.37 10 8002 432 2349641
Delirium 28.79 23.37 22 7990 5201 2344872
Irritable bowel syndrome 28.72 23.37 15 7997 1826 2348247
Extensor plantar response 28.70 23.37 9 8003 287 2349786
Drug withdrawal syndrome neonatal 28.66 23.37 10 8002 447 2349626
Myoglobin blood increased 28.64 23.37 9 8003 289 2349784
Acidosis hyperchloraemic 28.60 23.37 7 8005 86 2349987
Polyuria 28.59 23.37 13 7999 1169 2348904
Acquired cystic kidney disease 28.56 23.37 5 8007 8 2350065
Gastric mucosal hypertrophy 28.49 23.37 6 8006 35 2350038
Vitamin D deficiency 28.48 23.37 14 7998 1500 2348573
Faecaloma 28.42 23.37 12 8000 903 2349170
Paraesthesia oral 28.30 23.37 16 7996 2278 2347795
Generalised tonic-clonic seizure 28.24 23.37 22 7990 5350 2344723
Learning disorder 28.17 23.37 7 8005 92 2349981
Rash maculo-papular 28.14 23.37 20 7992 4232 2345841
Haemoglobin abnormal 28.05 23.37 11 8001 684 2349389
Feeling jittery 28.03 23.37 15 7997 1917 2348156
Glossodynia 27.94 23.37 15 7997 1930 2348143
Heart rate increased 27.80 23.37 30 7982 11075 2338998
Blood bicarbonate decreased 27.72 23.37 10 8002 493 2349580
Ventricular dysfunction 27.68 23.37 10 8002 495 2349578
Drooling 27.51 23.37 11 8001 720 2349353
Blood thyroid stimulating hormone increased 27.43 23.37 12 8000 985 2349088
Multimorbidity 27.31 23.37 7 8005 105 2349968
Periorbital oedema 27.19 23.37 12 8000 1006 2349067
Haemorrhage in pregnancy 27.09 23.37 9 8003 346 2349727
Disease recurrence 27.01 23.37 18 7994 3433 2346640
Antineutrophil cytoplasmic antibody positive 27.01 23.37 7 8005 110 2349963
Weight increased 26.89 23.37 42 7970 22295 2327778
Restlessness 26.88 23.37 20 7992 4543 2345530
Blood pressure decreased 26.80 23.37 27 7985 9209 2340864
Burning sensation 26.68 23.37 25 7987 7803 2342270
Hypertrichosis 26.67 23.37 8 8004 219 2349854
Erythema multiforme 26.37 23.37 15 7997 2160 2347913
Emotional disorder 26.36 23.37 15 7997 2162 2347911
Oral herpes 26.20 23.37 15 7997 2187 2347886
Nephropathy 26.16 23.37 11 8001 819 2349254
Neutropenic sepsis 26.13 23.37 13 7999 1429 2348644
Gastric ulcer haemorrhage 26.04 23.37 11 8001 829 2349244
Incontinence 26.03 23.37 13 7999 1441 2348632
Muscle disorder 25.91 23.37 11 8001 839 2349234
Helicobacter infection 25.88 23.37 10 8002 598 2349475
Femur fracture 25.86 23.37 23 7989 6716 2343357
Hepatic steatosis 25.73 23.37 17 7995 3196 2346877
Hepatitis cholestatic 25.72 23.37 12 8000 1145 2348928
Amaurosis 25.66 23.37 7 8005 135 2349938
Blood glucose increased 25.31 23.37 30 7982 12260 2337813
Purpura senile 25.30 23.37 5 8007 20 2350053
Faeces discoloured 25.24 23.37 15 7997 2344 2347729
Sinus tachycardia 25.20 23.37 17 7995 3308 2346765
Dysarthria 25.16 23.37 22 7990 6280 2343793
Joint swelling 25.11 23.37 35 7977 16784 2333289
Regurgitation 25.08 23.37 8 8004 270 2349803
Dysphonia 24.97 23.37 22 7990 6342 2343731
Tinnitus 24.78 23.37 20 7992 5115 2344958
Acidosis 24.77 23.37 13 7999 1597 2348476
Cholelithiasis 24.67 23.37 21 7991 5782 2344291
Burning mouth syndrome 24.65 23.37 6 8006 72 2350001
Alopecia 24.60 23.37 40 7972 21961 2328112
Anticholinergic syndrome 24.58 23.37 8 8004 288 2349785
Live birth 24.47 23.37 12 8000 1279 2348794
Feeling of body temperature change 24.41 23.37 10 8002 697 2349376
Suicidal ideation 24.40 23.37 28 7984 11059 2339014
Swelling face 24.39 23.37 26 7986 9467 2340606
Upper gastrointestinal haemorrhage 24.33 23.37 14 7998 2060 2348013
Gastrointestinal disorder 23.93 23.37 25 7987 8892 2341181
Differential white blood cell count abnormal 23.83 23.37 7 8005 178 2349895
Eczema eyelids 23.62 23.37 5 8007 30 2350043
Oropharyngeal pain 23.53 23.37 28 7984 11490 2338583
Aphthous ulcer 23.40 23.37 12 8000 1406 2348667
Aphasia 23.37 23.37 19 7993 4909 2345164

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 1831.17 28.57 388 6104 1710 1738579
Chronic kidney disease 1497.39 28.57 377 6115 3940 1736349
Acute kidney injury 1346.11 28.57 574 5918 34370 1705919
Tubulointerstitial nephritis 962.61 28.57 246 6246 2712 1737577
Hypocalcaemia 951.66 28.57 247 6245 2909 1737380
Drug interaction 807.10 28.57 377 6115 27581 1712708
Hyponatraemia 669.74 28.57 240 6252 8760 1731529
Completed suicide 659.01 28.57 279 6213 16033 1724256
End stage renal disease 582.35 28.57 122 6370 490 1739799
Renal injury 465.60 28.57 115 6377 1079 1739210
Gastrooesophageal reflux disease 421.97 28.57 144 6348 4503 1735786
Toxicity to various agents 420.97 28.57 248 6244 28893 1711396
Renal failure 303.23 28.57 176 6316 19841 1720448
Vomiting 269.64 28.57 209 6283 38106 1702183
Confusional state 267.51 28.57 166 6326 21112 1719177
Diarrhoea 263.60 28.57 238 6254 53614 1686675
Tetany 260.52 28.57 54 6438 202 1740087
Drug ineffective 242.10 28.57 245 6247 63556 1676733
Dyspepsia 233.04 28.57 95 6397 4890 1735399
Nausea 213.13 28.57 207 6285 50989 1689300
Hypokalaemia 210.55 28.57 95 6397 6279 1734010
Rhabdomyolysis 209.78 28.57 113 6379 10977 1729312
Dyspnoea 189.90 28.57 196 6296 51863 1688426
Inappropriate antidiuretic hormone secretion 161.63 28.57 55 6437 1693 1738596
Weight decreased 159.23 28.57 124 6368 22629 1717660
Product complaint 153.42 28.57 58 6434 2432 1737857
Drug reaction with eosinophilia and systemic symptoms 143.72 28.57 68 6424 5002 1735287
Hypoparathyroidism 143.50 28.57 28 6464 70 1740219
Toxic epidermal necrolysis 138.05 28.57 53 6439 2318 1737971
Decreased appetite 135.14 28.57 115 6377 23756 1716533
Malaise 134.80 28.57 126 6366 29439 1710850
Rash 132.35 28.57 141 6351 38552 1701737
Lower respiratory tract infection 132.17 28.57 59 6433 3792 1736497
Dizziness 129.66 28.57 132 6360 34229 1706060
Muscular weakness 128.50 28.57 80 6412 10169 1730120
Erythema 122.97 28.57 88 6404 14100 1726189
Pruritus 117.55 28.57 105 6387 23117 1717172
Type I hypersensitivity 116.76 28.57 29 6463 277 1740012
Muscle spasms 114.52 28.57 78 6414 11543 1728746
Abdominal pain 114.41 28.57 100 6392 21390 1718899
Drug hypersensitivity 113.42 28.57 86 6406 15049 1725240
Agitation 113.41 28.57 76 6416 10950 1729339
Hypoparathyroidism secondary 112.47 28.57 19 6473 11 1740278
Condition aggravated 109.74 28.57 97 6395 21053 1719236
Seizure 108.56 28.57 95 6397 20346 1719943
Tremor 108.19 28.57 79 6413 13052 1727237
Abdominal pain upper 106.40 28.57 73 6419 10928 1729361
Pyrexia 105.17 28.57 137 6355 46263 1694026
Asthenia 103.97 28.57 118 6374 34552 1705737
Paraesthesia 102.60 28.57 70 6422 10381 1729908
Wernicke's encephalopathy 102.11 28.57 22 6470 103 1740186
Pancreatitis acute 101.24 28.57 50 6442 4037 1736252
Blood creatinine increased 99.54 28.57 77 6415 13869 1726420
Chromaturia 98.65 28.57 43 6449 2607 1737682
Hypertension 98.49 28.57 88 6404 19360 1720929
Electrocardiogram QT prolonged 97.74 28.57 54 6438 5491 1734798
Subacute cutaneous lupus erythematosus 93.25 28.57 21 6471 125 1740164
Eosinophilia 92.90 28.57 45 6447 3482 1736807
Blood magnesium decreased 92.52 28.57 29 6463 683 1739606
Foetal exposure during pregnancy 90.85 28.57 54 6438 6305 1733984
Tachycardia 90.71 28.57 70 6422 12558 1727731
Pancytopenia 90.53 28.57 67 6425 11290 1728999
Constipation 90.39 28.57 75 6417 14925 1725364
Myalgia 89.63 28.57 76 6416 15582 1724707
Palpitations 87.40 28.57 54 6438 6760 1733529
Fatigue 86.80 28.57 131 6361 50650 1689639
Jejunal ulcer perforation 85.74 28.57 14 6478 4 1740285
Skin exfoliation 84.99 28.57 46 6446 4489 1735800
Ischaemic stroke 84.52 28.57 41 6451 3181 1737108
Agranulocytosis 83.39 28.57 42 6450 3534 1736755
Occupational dermatitis 81.02 28.57 13 6479 2 1740287
Drug level increased 80.96 28.57 38 6454 2739 1737550
Product substitution issue 80.77 28.57 40 6452 3246 1737043
Overdose 79.46 28.57 73 6419 16628 1723661
Hepatitis 78.49 28.57 45 6447 4910 1735379
Jaundice 77.63 28.57 48 6444 6014 1734275
Blood calcium decreased 77.34 28.57 30 6462 1347 1738942
Renal impairment 77.15 28.57 63 6429 12251 1728038
Clostridium difficile infection 76.53 28.57 32 6460 1749 1738540
Anxiety 76.07 28.57 69 6423 15458 1724831
Nephrogenic anaemia 75.52 28.57 19 6473 192 1740097
Pancreatitis 74.95 28.57 50 6442 7137 1733152
Wheezing 74.70 28.57 41 6451 4112 1736177
Pyloric stenosis 74.23 28.57 18 6474 154 1740135
Macrocephaly 74.13 28.57 15 6477 48 1740241
Lethargy 72.56 28.57 49 6443 7135 1733154
Liver function test abnormal 72.46 28.57 45 6447 5681 1734608
Dehydration 72.23 28.57 71 6421 17587 1722702
Cardio-respiratory arrest 72.19 28.57 54 6438 9239 1731050
Oedema peripheral 72.08 28.57 67 6425 15483 1724806
Atrial septal defect 70.68 28.57 28 6464 1330 1738959
Dysphagia 70.03 28.57 55 6437 10113 1730176
Headache 69.31 28.57 96 6396 34280 1706009
Cough 69.04 28.57 72 6420 19125 1721164
Loss of consciousness 68.77 28.57 64 6428 14811 1725478
Dermatomyositis 66.31 28.57 18 6474 250 1740039
Hypotension 66.14 28.57 87 6405 29567 1710722
Chronic obstructive pulmonary disease 65.91 28.57 43 6449 5910 1734379
Drug eruption 64.24 28.57 33 6459 2893 1737396
Iron deficiency anaemia 63.81 28.57 25 6467 1153 1739136
Rectal haemorrhage 63.73 28.57 41 6451 5501 1734788
Anaemia 63.50 28.57 85 6407 29372 1710917
Gait disturbance 63.41 28.57 57 6435 12613 1727676
Hypoglycaemia 63.24 28.57 48 6444 8390 1731899
Urticaria 63.10 28.57 56 6436 12185 1728104
Alanine aminotransferase increased 62.95 28.57 56 6436 12222 1728067
Stevens-Johnson syndrome 62.74 28.57 34 6458 3323 1736966
Cholestasis 62.66 28.57 35 6457 3630 1736659
Depression 62.60 28.57 64 6428 16605 1723684
Intellectual disability 62.03 28.57 16 6476 180 1740109
Ataxia 61.88 28.57 30 6462 2323 1737966
Vitamin B12 deficiency 60.71 28.57 18 6474 349 1739940
Antipsychotic drug level decreased 60.69 28.57 15 6477 140 1740149
Steatorrhoea 59.71 28.57 14 6478 102 1740187
Clostridium difficile colitis 59.59 28.57 26 6466 1578 1738711
Hyperchlorhydria 59.58 28.57 15 6477 152 1740137
Hypertrichosis 59.36 28.57 14 6478 105 1740184
Pain 59.10 28.57 78 6414 26579 1713710
Skin lesion 58.06 28.57 31 6461 2941 1737348
Renal tubular acidosis 58.01 28.57 17 6475 316 1739973
Acute generalised exanthematous pustulosis 57.92 28.57 23 6469 1099 1739190
Therapeutic product cross-reactivity 57.43 28.57 16 6476 246 1740043
Cognitive disorder 57.24 28.57 35 6457 4295 1735994
Alveolitis 56.98 28.57 17 6475 337 1739952
Rash pustular 56.73 28.57 23 6469 1161 1739128
Vascular purpura 55.66 28.57 16 6476 277 1740012
Occupational exposure to air contaminants 55.57 28.57 9 6483 2 1740287
Dry mouth 55.26 28.57 33 6459 3880 1736409
Atrial fibrillation 54.88 28.57 57 6435 15054 1725235
Pupils unequal 54.43 28.57 15 6477 221 1740068
Arthralgia 54.13 28.57 70 6422 23374 1716915
Tetanus 53.83 28.57 10 6482 17 1740272
Labelled drug-drug interaction medication error 53.80 28.57 23 6469 1328 1738961
Coma 53.73 28.57 41 6451 7221 1733068
Granuloma annulare 53.49 28.57 11 6481 39 1740250
Angioedema 53.39 28.57 46 6446 9618 1730671
Suicide attempt 53.13 28.57 41 6451 7340 1732949
Insomnia 53.11 28.57 58 6434 16218 1724071
Acute respiratory distress syndrome 52.90 28.57 31 6461 3520 1736769
Blood creatine phosphokinase increased 52.70 28.57 44 6448 8812 1731477
Renal tubular necrosis 52.67 28.57 26 6466 2093 1738196
Paranoia 51.96 28.57 26 6466 2155 1738134
Delirium 51.70 28.57 38 6454 6324 1733965
Gastric polyps 51.27 28.57 14 6478 199 1740090
Dysarthria 51.02 28.57 35 6457 5224 1735065
Hepatitis cholestatic 50.99 28.57 22 6470 1299 1738990
Anaphylactic reaction 50.77 28.57 37 6455 6076 1734213
Dermatitis exfoliative 50.60 28.57 23 6469 1538 1738751
Hypersensitivity 50.30 28.57 46 6446 10398 1729891
Premature baby 50.03 28.57 28 6464 2914 1737375
Therapeutic product effect decreased 49.79 28.57 37 6455 6260 1734029
Rash erythematous 49.74 28.57 31 6461 3934 1736355
Gynaecomastia 49.57 28.57 25 6467 2107 1738182
Medication error 49.43 28.57 33 6459 4710 1735579
Generalised tonic-clonic seizure 49.17 28.57 31 6461 4015 1736274
Blood alkaline phosphatase increased 49.05 28.57 34 6458 5161 1735128
Fall 48.90 28.57 72 6420 27142 1713147
Blood parathyroid hormone decreased 48.74 28.57 12 6480 110 1740179
Right hemisphere deficit syndrome 48.45 28.57 8 6484 3 1740286
Hypophosphataemia 47.93 28.57 21 6471 1287 1739002
Muscle contractions involuntary 47.72 28.57 16 6476 469 1739820
Inhibitory drug interaction 47.38 28.57 14 6478 268 1740021
Interstitial lung disease 47.27 28.57 43 6449 9653 1730636
Cardiac arrest 47.22 28.57 54 6438 15876 1724413
Abnormal loss of weight 46.38 28.57 16 6476 512 1739777
Abdominal discomfort 45.70 28.57 41 6451 9040 1731249
Mental impairment 45.47 28.57 23 6469 1950 1738339
Intentional overdose 45.41 28.57 38 6454 7632 1732657
Thrombocytopenia 45.25 28.57 61 6431 21188 1719101
Hyperhidrosis 45.14 28.57 47 6445 12441 1727848
Somnolence 45.05 28.57 54 6438 16685 1723604
Gamma-glutamyltransferase increased 44.95 28.57 32 6460 5066 1735223
Congenital oesophageal anomaly 44.52 28.57 8 6484 10 1740279
Oropharyngeal pain 44.23 28.57 31 6461 4787 1735502
Cerebral vasoconstriction 44.05 28.57 10 6482 62 1740227
Chest pain 43.68 28.57 58 6434 19856 1720433
Orthostatic hypotension 43.48 28.57 27 6465 3404 1736885
Hallucination 43.32 28.57 38 6454 8132 1732157
Circulatory collapse 43.22 28.57 27 6465 3440 1736849
Cardiovascular disorder 42.56 28.57 24 6468 2533 1737756
Electrolyte imbalance 42.33 28.57 20 6472 1461 1738828
Flatulence 42.09 28.57 25 6467 2909 1737380
Nephritis 41.16 28.57 14 6478 429 1739860
C-reactive protein increased 40.85 28.57 32 6460 5853 1734436
Fixed eruption 40.84 28.57 12 6480 225 1740064
Urine sodium decreased 40.71 28.57 8 6484 21 1740268
Chest discomfort 40.69 28.57 35 6457 7296 1732993
Abdominal distension 40.38 28.57 33 6459 6411 1733878
General physical health deterioration 39.77 28.57 45 6447 13073 1727216
Oesophagitis 39.70 28.57 20 6472 1681 1738608
Myoclonus 39.45 28.57 22 6470 2273 1738016
Blood sodium decreased 39.37 28.57 22 6470 2282 1738007
Hypoosmolar state 39.29 28.57 7 6485 8 1740281
Poisoning deliberate 39.11 28.57 16 6476 826 1739463
Disorientation 38.52 28.57 30 6462 5439 1734850
Urinary tract discomfort 38.42 28.57 7 6485 10 1740279
Low birth weight baby 38.31 28.57 16 6476 871 1739418
Hypoventilation 38.27 28.57 14 6478 533 1739756
Lip swelling 37.98 28.57 23 6469 2772 1737517
Hyperkalaemia 37.97 28.57 36 6456 8511 1731778
Hepatocellular injury 37.37 28.57 24 6468 3207 1737082
Renal haemangioma 37.32 28.57 6 6486 1 1740288
Hypersensitivity vasculitis 36.98 28.57 17 6475 1167 1739122
Swelling face 36.91 28.57 27 6465 4456 1735833
Barrett's oesophagus 36.89 28.57 12 6480 319 1739970
Heart rate irregular 36.89 28.57 19 6473 1673 1738616
Induration 36.87 28.57 11 6481 218 1740071
Use of accessory respiratory muscles 36.80 28.57 9 6483 80 1740209
Blister 36.80 28.57 26 6466 4066 1736223
Feeling abnormal 36.76 28.57 40 6452 11126 1729163
White blood cell count increased 36.75 28.57 33 6459 7279 1733010
Metabolic acidosis 36.68 28.57 29 6463 5373 1734916
Coordination abnormal 36.11 28.57 18 6474 1479 1738810
Amylase increased 36.07 28.57 17 6475 1235 1739054
Muscle twitching 35.76 28.57 19 6473 1783 1738506
Splenomegaly 35.56 28.57 20 6472 2100 1738189
Restlessness 35.52 28.57 26 6466 4295 1735994
Syncope 35.34 28.57 44 6448 14125 1726164
Diabetic neuropathy 35.31 28.57 13 6479 504 1739785
Vasculitis 35.25 28.57 18 6474 1557 1738732
Pseudomembranous colitis 35.22 28.57 13 6479 508 1739781
Cerebral atrophy congenital 35.19 28.57 6 6486 4 1740285
Red blood cell sedimentation rate increased 35.10 28.57 16 6476 1077 1739212
Myositis 34.95 28.57 18 6474 1585 1738704
Respiratory arrest 34.70 28.57 29 6463 5810 1734479
Rash macular 34.61 28.57 19 6473 1903 1738386
Respiratory failure 34.52 28.57 44 6448 14461 1725828
Cardiac failure 34.46 28.57 41 6451 12561 1727728
Neutrophil count increased 34.36 28.57 21 6471 2572 1737717
Polymyositis 33.87 28.57 11 6481 291 1739998
Lung disorder 33.73 28.57 27 6465 5092 1735197
Photosensitivity reaction 33.46 28.57 18 6474 1732 1738557
Coma scale abnormal 33.45 28.57 13 6479 586 1739703
Gastric mucosal hypertrophy 33.37 28.57 7 6485 28 1740261
Gastrointestinal disorder 33.34 28.57 26 6466 4722 1735567
Gastritis 33.23 28.57 22 6470 3095 1737194
Erythema of eyelid 33.20 28.57 10 6482 205 1740084
Nail pigmentation 33.18 28.57 7 6485 29 1740260
Tongue oedema 33.14 28.57 13 6479 601 1739688
Pneumonia aspiration 33.06 28.57 27 6465 5239 1735050
Cerebellar ataxia 32.88 28.57 10 6482 212 1740077
Homicide 32.85 28.57 11 6481 321 1739968
Haemoptysis 32.73 28.57 26 6466 4850 1735439
Gastrointestinal polyp haemorrhage 32.43 28.57 8 6484 74 1740215
Dermatitis contact 32.36 28.57 13 6479 640 1739649
Heart rate increased 31.97 28.57 29 6463 6481 1733808
Dysgeusia 31.93 28.57 26 6466 5023 1735266
Chills 31.91 28.57 38 6454 11649 1728640
Lipase increased 31.88 28.57 17 6475 1607 1738682
Tonsil cancer 31.85 28.57 9 6483 146 1740143
Skin plaque 31.82 28.57 14 6478 866 1739423
Occupational exposure to product 31.79 28.57 9 6483 147 1740142
Unresponsive to stimuli 31.75 28.57 25 6467 4604 1735685
Eructation 31.61 28.57 13 6479 680 1739609
Tooth injury 31.51 28.57 8 6484 84 1740205
Polyhydramnios 31.47 28.57 7 6485 39 1740250
Cerebellar syndrome 31.39 28.57 12 6480 517 1739772
Oropharyngeal swelling 31.29 28.57 9 6483 156 1740133
Hypertransaminasaemia 31.26 28.57 12 6480 523 1739766
Eczema 31.25 28.57 19 6473 2305 1737984
Product monitoring error 31.17 28.57 8 6484 88 1740201
Transaminases increased 30.92 28.57 23 6469 3894 1736395
Epigastric discomfort 30.73 28.57 11 6481 393 1739896
Gastrointestinal haemorrhage 30.41 28.57 41 6451 14226 1726063
Clostridium test positive 30.39 28.57 10 6482 276 1740013
Haemoglobin decreased 30.30 28.57 45 6447 17069 1723220
Regurgitation 30.13 28.57 9 6483 179 1740110
Rash maculo-papular 29.80 28.57 22 6470 3681 1736608
Mucosal inflammation 29.64 28.57 23 6469 4146 1736143
Hypotonia 29.60 28.57 16 6476 1554 1738735
Hair colour changes 29.53 28.57 11 6481 441 1739848
Hyperreflexia 29.53 28.57 12 6480 609 1739680
Neutropenia 29.48 28.57 46 6446 18214 1722075
Urinary tract infection 29.36 28.57 34 6458 10119 1730170
Dyschezia 29.32 28.57 9 6483 197 1740092
Haemorrhagic transformation stroke 29.26 28.57 10 6482 311 1739978
Sedation 29.08 28.57 21 6471 3396 1736893
Skin depigmentation 28.95 28.57 8 6484 119 1740170
Gastric ulcer 28.74 28.57 19 6473 2666 1737623
Renal tubular disorder 28.70 28.57 13 6479 862 1739427

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
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:49201 anti-ulcer drug
CHEBI has role CHEBI:35623 anticonvulsant
FDA EPC N0000175525 Proton Pump Inhibitor
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Peptic ulcer indication 13200003 DOID:750
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
Gastric Hypersecretory Conditions indication
Duodenal Ulcer due to H. Pylori indication
Maintenance of Healing Erosive Esophagitis indication
Pathological Gastric Hypersecretory Condition 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

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
40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 RX 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
40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 RX 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
40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 RX 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
40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 RX 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
40MG YOSPRALA GENUS LIFESCIENCES N205103 Sept. 14, 2016 RX 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
EQ 10MG BASE TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9050263 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
EQ 10MG BASE TALICIA REDHILL N213004 Nov. 1, 2019 RX CAPSULE, DELAYED RELEASE ORAL 9498445 Feb. 12, 2034 TREATMENT OF H. PYLORI INFECTION IN ADULTS
EQ 10MG BASE 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
Cytochrome P450 2C19 Enzyme Ki 5.30 WOMBAT-PK
Cytochrome P450 1A2 Enzyme IC50 4.74 WOMBAT-PK
Cytochrome P450 2C9 Enzyme Ki 4.35 WOMBAT-PK
Cytochrome P450 3A4 Enzyme Km 4.31 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 4.05 WOMBAT-PK
Fatty acid synthase Enzyme Ki 5.47 CHEMBL
Potassium-transporting ATPase Enzyme IC50 5.42 CHEMBL
Potassium-transporting ATPase Enzyme IC50 6.15 SCIENTIFIC LITERATURE

External reference:

IDSource
4019439 VUID
N0000147569 NUI
C0028978 UMLSCUI
D00455 KEGG_DRUG
426QFE7XLK UNII
95382-33-5 SECONDARY_CAS_RN
25673006 SNOMEDCT_US
4019439 VANDF
45807 MMSL
7646 RXNORM
387137007 SNOMEDCT_US
5201 MMSL
d00325 MMSL
003476 NDDF
CHEMBL1503 ChEMBL_ID
DB00338 DRUGBANK_ID
5081 INN_ID
1C6 PDB_CHEM_ID
CHEBI:7772 CHEBI
D009853 MESH_DESCRIPTOR_UI
CHEMBL1567328 ChEMBL_ID
CHEMBL2105294 ChEMBL_ID
4594 PUBCHEM_CID
4279 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0093-5294 CAPSULE, DELAYED RELEASE PELLETS 40 mg ORAL ANDA 20 sections
Good Sense omeprazole HUMAN OTC DRUG LABEL 1 0113-0045 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 15 sections
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 9 sections
Good Sense Omeprazole HUMAN OTC DRUG LABEL 1 0113-1723 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 9 sections
Omeprazole Magnesium HUMAN OTC DRUG LABEL 1 0179-8104 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 9 sections
PRILOSEC HUMAN PRESCRIPTION DRUG LABEL 1 0186-0606 CAPSULE, DELAYED RELEASE 10 mg ORAL NDA 19 sections
PRILOSEC HUMAN PRESCRIPTION DRUG LABEL 1 0186-0610 GRANULE, DELAYED RELEASE 10 mg ORAL NDA 19 sections
PRILOSEC HUMAN PRESCRIPTION DRUG LABEL 1 0186-0625 GRANULE, DELAYED RELEASE 2.50 mg ORAL NDA 19 sections
PRILOSEC HUMAN PRESCRIPTION DRUG LABEL 1 0186-0742 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 19 sections
PRILOSEC HUMAN PRESCRIPTION DRUG LABEL 1 0186-0743 CAPSULE, DELAYED RELEASE 40 mg ORAL NDA 19 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 9 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 9 sections
Omeprazole HUMAN OTC DRUG LABEL 1 0363-1607 TABLET, DELAYED RELEASE 20 mg ORAL ANDA 9 sections
omeprazole HUMAN OTC DRUG LABEL 1 0363-1819 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE 20 mg ORAL NDA 15 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-1359 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 18 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-2302 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 18 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-2305 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 18 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-7933 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 19 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8079 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 19 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0615-8320 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 19 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2234 CAPSULE, DELAYED RELEASE 40 mg ORAL ANDA 19 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2785 CAPSULE, DELAYED RELEASE 10 mg ORAL ANDA 19 sections
Omeprazole HUMAN PRESCRIPTION DRUG LABEL 1 0781-2790 CAPSULE, DELAYED RELEASE 20 mg ORAL ANDA 19 sections