ranitidine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
histamine-H2-receptor antagonists, cimetidine derivatives 2358 66357-35-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zantac
  • zenetac
  • ranitidine hydrochloride
  • ranitidine HCl
  • ranitidine
A non-imidazole blocker of those histamine receptors that mediate gastric secretion (H2 receptors). It is used to treat gastrointestinal ulcers.
  • Molecular weight: 314.40
  • Formula: C13H22N4O3S
  • CLOGP: 0.67
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 83.58
  • ALOGS: -3.60
  • ROTB: 10

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O
0.30 g P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 28.50 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
S (Water solubility) 555 mg/mL Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 69 % Hosey CM, Chan R, Benet LZ
BA (Bioavailability) 52 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.20 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.95 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 29, 1977 FDA SANDOZ

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
Breast cancer stage I 4739.36 9.65 1117 150351 873 50452783
Breast cancer stage II 4134.10 9.65 967 150501 700 50452956
Colorectal cancer 2610.90 9.65 646 150822 761 50452895
Breast cancer female 2464.73 9.65 884 150584 5978 50447678
Renal cancer 1802.87 9.65 594 150874 2986 50450670
Breast cancer stage III 1674.88 9.65 549 150919 2707 50450949
Colorectal cancer stage IV 1671.00 9.65 347 151121 0 50453656
Colorectal cancer stage III 1666.19 9.65 346 151122 0 50453656
Uterine cancer 1488.73 9.65 523 150945 3297 50450359
Oesophageal carcinoma 1255.23 9.65 342 151126 740 50452916
Breast cancer stage IV 1246.50 9.65 303 151165 310 50453346
Hepatic cancer stage IV 1212.35 9.65 253 151215 6 50453650
Bladder cancer 1142.80 9.65 415 151053 2917 50450739
Colorectal cancer stage II 1059.33 9.65 220 151248 0 50453656
Pancreatic carcinoma stage IV 1006.62 9.65 217 151251 42 50453614
Renal cancer stage I 752.98 9.65 157 151311 3 50453653
Thyroid cancer 711.55 9.65 314 151154 3855 50449801
Renal cancer stage IV 708.45 9.65 154 151314 37 50453619
Colorectal cancer stage I 698.16 9.65 145 151323 0 50453656
Gastric cancer 680.47 9.65 277 151191 2741 50450915
Lung carcinoma cell type unspecified stage IV 658.84 9.65 189 151279 531 50453125
Renal cancer stage II 568.15 9.65 118 151350 0 50453656
Gastric cancer stage IV 552.15 9.65 127 151341 76 50453580
Hepatic cancer 531.11 9.65 238 151230 3037 50450619
Renal cancer stage III 510.37 9.65 106 151362 0 50453656
Haematological malignancy 495.04 9.65 122 151346 139 50453517
Gastrointestinal carcinoma 485.02 9.65 178 151290 1293 50452363
Pancreatic carcinoma 395.13 9.65 241 151227 5973 50447683
Thyroid cancer stage I 375.55 9.65 78 151390 0 50453656
Bladder cancer stage IV 346.66 9.65 72 151396 0 50453656
Drug ineffective 310.94 9.65 1333 150135 818000 49635656
Brain neoplasm malignant 292.39 9.65 107 151361 770 50452886
Systemic lupus erythematosus 287.24 9.65 40 151428 140582 50313074
Synovitis 287.01 9.65 22 151446 123843 50329813
Bladder cancer stage II 274.43 9.65 57 151411 0 50453656
Ovarian cancer stage I 274.43 9.65 57 151411 0 50453656
Erythema 265.94 9.65 1002 150466 145412 50308244
Food allergy 249.80 9.65 202 151266 7935 50445721
Ovarian cancer stage IV 240.44 9.65 59 151409 65 50453591
Gastric cancer stage III 235.92 9.65 49 151419 0 50453656
Ovarian cancer 232.23 9.65 161 151307 4988 50448668
Lung carcinoma cell type unspecified stage III 229.61 9.65 54 151414 41 50453615
Glossodynia 228.78 9.65 36 151432 115533 50338123
Bladder cancer stage III 226.29 9.65 47 151421 0 50453656
Treatment failure 225.50 9.65 66 151402 137571 50316085
Lung neoplasm malignant 224.59 9.65 254 151214 15230 50438426
Thyroid cancer stage II 216.66 9.65 45 151423 0 50453656
Lung carcinoma cell type unspecified stage I 213.40 9.65 53 151415 64 50453592
Arthropathy 211.64 9.65 104 151364 157802 50295854
Hand deformity 210.58 9.65 26 151442 100173 50353483
Breast cancer 202.93 9.65 417 151051 42473 50411183
Pancreatic carcinoma stage III 202.21 9.65 42 151426 0 50453656
Temperature regulation disorder 199.68 9.65 136 151332 4091 50449565
Gastric cancer stage I 197.40 9.65 41 151427 0 50453656
Completed suicide 195.54 9.65 75 151393 131814 50321842
Anti-cyclic citrullinated peptide antibody positive 191.55 9.65 4 151464 70583 50383073
Urinary sediment present 188.01 9.65 100 151368 1891 50451765
Lymphocyte count decreased 185.57 9.65 304 151164 26003 50427653
Lung carcinoma cell type unspecified stage II 179.53 9.65 44 151424 48 50453608
Pericarditis 179.38 9.65 15 151453 78674 50374982
Urine abnormality 177.12 9.65 148 151320 6090 50447566
Toxicity to various agents 175.71 9.65 227 151241 212272 50241384
Crystal urine present 173.86 9.65 86 151382 1388 50452268
Wound 172.76 9.65 51 151417 105743 50347913
Skin cancer 169.51 9.65 173 151295 9221 50444435
Pancreatic carcinoma stage II 168.51 9.65 35 151433 0 50453656
Pancreatic carcinoma stage I 168.51 9.65 35 151433 0 50453656
Flushing 164.95 9.65 508 150960 66507 50387149
Joint swelling 153.21 9.65 315 151153 244971 50208685
Appendix cancer 153.10 9.65 37 151431 36 50453620
Neoplasm malignant 152.56 9.65 263 151205 23452 50430204
Toothache 146.84 9.65 215 151253 16679 50436977
Anaphylactic reaction 143.62 9.65 421 151047 53634 50400022
Alopecia 142.04 9.65 328 151140 244719 50208937
Drug intolerance 137.97 9.65 280 151188 218824 50234832
White blood cells urine positive 137.04 9.65 112 151356 4466 50449190
Rheumatoid factor positive 134.59 9.65 3 151465 49856 50403800
Red blood cells urine positive 132.78 9.65 90 151378 2685 50450971
Thyroid cancer stage IV 129.99 9.65 27 151441 0 50453656
Gastric cancer stage II 129.99 9.65 27 151441 0 50453656
Chronic kidney disease 129.77 9.65 334 151134 39437 50414219
Urine leukocyte esterase positive 129.67 9.65 90 151378 2793 50450863
Immunodeficiency 129.30 9.65 189 151279 14639 50439017
Ovarian cancer stage II 121.52 9.65 27 151441 10 50453646
Contraindicated product administered 121.13 9.65 161 151307 148797 50304859
Coeliac disease 120.08 9.65 139 151329 8546 50445110
Lymphocyte percentage decreased 119.10 9.65 84 151384 2676 50450980
Urine analysis abnormal 118.96 9.65 101 151367 4249 50449407
Neutrophil percentage increased 117.68 9.65 83 151385 2644 50451012
Swelling 113.85 9.65 272 151196 200600 50253056
Gastrooesophageal reflux disease 113 9.65 491 150977 75937 50377719
Cervix carcinoma 110.94 9.65 78 151390 2472 50451184
Maternal exposure during pregnancy 106.78 9.65 197 151271 159581 50294075
Schizoaffective disorder 106.64 9.65 72 151396 2134 50451522
Helicobacter infection 106.62 9.65 12 151456 49690 50403966
Duodenal ulcer perforation 105.88 9.65 8 151460 45603 50408053
Feeling hot 102.85 9.65 304 151164 38898 50414758
Cervix carcinoma stage II 100.63 9.65 22 151446 6 50453650
Incorrect dose administered 98.44 9.65 344 151124 48070 50405586
Drug abuse 97.40 9.65 29 151439 59817 50393839
Folliculitis 96.67 9.65 5 151463 39220 50414436
Prostate cancer 96.29 9.65 20 151448 0 50453656
Small intestine carcinoma stage IV 96.29 9.65 20 151448 0 50453656
Urticaria 96.27 9.65 691 150777 128870 50324786
Ovarian cancer stage III 96.25 9.65 33 151435 191 50453465
Blood urine present 91.44 9.65 149 151319 12684 50440972
Chest discomfort 91.27 9.65 531 150937 92191 50361465
Bone cancer 91.10 9.65 52 151416 1135 50452521
Bursitis 90.62 9.65 203 151265 21932 50431724
Death 90.21 9.65 587 150881 324792 50128864
Muscle injury 87.60 9.65 6 151462 37105 50416551
Therapeutic product effect incomplete 87.25 9.65 87 151381 91428 50362228
Discomfort 87.21 9.65 118 151350 108262 50345394
Thyroid cancer stage III 86.66 9.65 18 151450 0 50453656
Rash erythematous 85.53 9.65 264 151204 34588 50419068
Hepatic cancer stage III 81.85 9.65 17 151451 0 50453656
Mean cell haemoglobin decreased 80.48 9.65 72 151396 3251 50450405
Abdominal discomfort 79.83 9.65 389 151079 231252 50222404
Therapeutic product effect decreased 78.81 9.65 182 151286 135868 50317788
Hepatic cancer stage II 77.03 9.65 16 151452 0 50453656
Pharyngitis 76.73 9.65 165 151303 17338 50436318
Haemoglobin urine present 74.75 9.65 40 151428 766 50452890
Bacterial test 73.87 9.65 45 151423 1112 50452544
Small intestine carcinoma 72.92 9.65 31 151437 345 50453311
Thyroid cancer stage 0 72.22 9.65 15 151453 0 50453656
Cervix carcinoma stage I 69.29 9.65 16 151452 10 50453646
Pneumonia aspiration 64.49 9.65 222 151246 30782 50422874
Throat cancer 62.66 9.65 30 151438 449 50453207
Bacterial test positive 62.64 9.65 74 151394 4649 50449007
Gamma-glutamyltransferase decreased 61.51 9.65 26 151442 285 50453371
Hereditary angioedema 60.47 9.65 78 151390 5364 50448292
Infection 59.80 9.65 290 151178 172664 50280992
Disease progression 58.76 9.65 489 150979 95377 50358279
Cervix carcinoma stage IV 58.25 9.65 14 151454 13 50453643
Synovial fluid analysis 57.46 9.65 44 151424 1594 50452062
Intentional overdose 56.66 9.65 62 151406 62442 50391214
Infusion site coldness 56.45 9.65 22 151446 192 50453464
Fall 55.82 9.65 688 150780 334244 50119412
Loss of personal independence in daily activities 54.60 9.65 78 151390 69972 50383684
Irritable bowel syndrome 53.66 9.65 45 151423 51396 50402260
Back pain 53.65 9.65 941 150527 219089 50234567
Urine ketone body present 53.46 9.65 49 151419 2284 50451372
Hepatic cancer stage I 52.96 9.65 11 151457 0 50453656
Monocyte percentage increased 52.78 9.65 35 151433 1006 50452650
Hyperhidrosis 52.60 9.65 452 151016 88974 50364682
Impaired healing 52.16 9.65 80 151388 69706 50383950
Tenosynovitis stenosans 51.52 9.65 47 151421 2177 50451479
Overdose 50.34 9.65 143 151325 99584 50354072
C-reactive protein abnormal 49.99 9.65 11 151457 27798 50425858
Headache 47.52 9.65 1909 149559 504626 49949030
Abdominal pain upper 47.29 9.65 704 150764 158605 50295051
Hip arthroplasty 47.27 9.65 16 151452 30413 50423243
Off label use 47.04 9.65 1072 150396 473354 49980302
Nitrite urine present 46.60 9.65 31 151437 896 50452760
Brain stem glioma 46.02 9.65 17 151451 126 50453530
Atelectasis 45.38 9.65 139 151329 18131 50435525
Computerised tomogram thorax abnormal 43.86 9.65 35 151433 1348 50452308
Cervix carcinoma stage III 43.71 9.65 12 151456 27 50453629
Pain 43.30 9.65 1362 150106 577541 49876115
Injection site pain 43.27 9.65 178 151290 110846 50342810
Mastocytosis 43.26 9.65 24 151444 495 50453161
Knee arthroplasty 43.06 9.65 27 151441 35819 50417837
Hypoaesthesia 42.83 9.65 575 150893 126682 50326974
Drug resistance 42.23 9.65 4 151464 18985 50434671
Red blood cell sedimentation rate increased 41.49 9.65 18 151450 29398 50424258
Upper respiratory tract infection 41.36 9.65 338 151130 65560 50388096
Infusion related reaction 40.97 9.65 318 151150 169239 50284417
Thyroxine free increased 40.78 9.65 27 151441 774 50452882
Rheumatoid arthritis 40.48 9.65 399 151069 202151 50251505
Scleritis 40.24 9.65 49 151419 3178 50450478
Constipation 38.93 9.65 776 150692 184932 50268724
Device expulsion 38.54 9.65 19 151449 28803 50424853
Small intestine carcinoma stage II 38.52 9.65 8 151460 0 50453656
Mobility decreased 37.92 9.65 118 151350 79830 50373826
Urinary casts 37.81 9.65 24 151444 639 50453017
Condition aggravated 37.61 9.65 644 150824 296414 50157242
Infective pulmonary exacerbation of cystic fibrosis 37.50 9.65 77 151391 7832 50445824
Adverse event 36.88 9.65 46 151422 43717 50409939
Sense of oppression 36.75 9.65 27 151441 918 50452738
Cushingoid 36.73 9.65 69 151399 6576 50447080
Throat tightness 36.37 9.65 141 151327 20706 50432950
Blood thyroid stimulating hormone decreased 36.11 9.65 53 151415 4119 50449537
Culture urine positive 36.07 9.65 48 151420 3403 50450253
Brain cancer metastatic 35.21 9.65 12 151456 68 50453588
Lactic acidosis 35.00 9.65 29 151439 33326 50420330
Fluid retention 34.64 9.65 265 151203 50384 50403272
Gallbladder cancer 34.61 9.65 17 151451 270 50453386
Specific gravity urine decreased 34.59 9.65 23 151445 664 50452992
Red cell distribution width increased 34.47 9.65 78 151390 8481 50445175
Gait inability 34.44 9.65 209 151259 36818 50416838
Pancytopenia 33.82 9.65 133 151335 83897 50369759
Suicide attempt 33.45 9.65 65 151403 51667 50401989
Bronchospasm 33.22 9.65 109 151359 14745 50438911
Pleuritic pain 33.11 9.65 65 151403 6401 50447255
General physical health deterioration 33.08 9.65 270 151198 142164 50311492
Angioedema 32.75 9.65 209 151259 37467 50416189
Chills 32.57 9.65 437 151031 96250 50357406
Perfume sensitivity 32.18 9.65 21 151447 587 50453069
Premature labour 32.02 9.65 91 151377 11385 50442271
Infusion site induration 31.84 9.65 24 151444 849 50452807
Infusion site pain 31.67 9.65 95 151373 12251 50441405
Osteonecrosis of jaw 30.89 9.65 31 151437 32495 50421161
Blepharospasm 30.81 9.65 41 151427 2907 50450749
Injection site reaction 30.53 9.65 65 151403 49967 50403689
Psoriatic arthropathy 30.49 9.65 59 151409 46973 50406683
Loss of employment 30.06 9.65 30 151438 1556 50452100
Tri-iodothyronine free increased 30.01 9.65 14 151454 197 50453459
Thyroxine free decreased 29.83 9.65 19 151449 509 50453147
Intentional product use issue 29.54 9.65 124 151344 76794 50376862
Drug eruption 29.45 9.65 17 151451 23589 50430067
Urine leukocyte esterase 29.27 9.65 12 151456 121 50453535
Abortion spontaneous 29.22 9.65 50 151418 41722 50411934
Vasodilatation 29.06 9.65 35 151433 2244 50451412
Stomatitis 28.93 9.65 181 151287 101163 50352493
Therapy non-responder 28.92 9.65 69 151399 50953 50402703
Small intestine carcinoma stage III 28.89 9.65 6 151462 0 50453656
Gallbladder cancer stage IV 28.89 9.65 6 151462 0 50453656
Anal cancer stage III 28.89 9.65 6 151462 0 50453656
Gastric cancer stage 0 28.89 9.65 6 151462 0 50453656
Crepitations 28.85 9.65 60 151408 6159 50447497
Product use issue 28.79 9.65 297 151171 149178 50304478
Cestode infection 28.76 9.65 15 151453 272 50453384
Multiple organ dysfunction syndrome 28.59 9.65 68 151400 50269 50403387
Lip pruritus 28.38 9.65 21 151447 722 50452934
Drug reaction with eosinophilia and systemic symptoms 28.27 9.65 26 151442 28398 50425258
Myocardial infarction 28.07 9.65 154 151314 88873 50364783
Antinuclear antibody 28.07 9.65 18 151450 488 50453168
Cells in urine 28.06 9.65 13 151455 180 50453476
Weight increased 27.73 9.65 431 151037 201460 50252196
Cardiac failure congestive 27.70 9.65 144 151324 84238 50369418
Hepatic enzyme increased 27.69 9.65 270 151198 137110 50316546
Protein urine present 27.47 9.65 54 151414 5323 50448333
Oropharyngeal oedema 27.44 9.65 14 151454 242 50453414
Arthritis 27.35 9.65 150 151318 86571 50367085
Anaemia 27.08 9.65 563 150905 251893 50201763
Asthma 26.95 9.65 396 151072 88941 50364715
Mean cell haemoglobin concentration increased 26.84 9.65 17 151451 451 50453205
Septic shock 26.68 9.65 85 151383 57090 50396566
Blood creatinine decreased 26.67 9.65 51 151417 4925 50448731
Therapeutic response decreased 26.67 9.65 64 151404 47167 50406489
Serotonin syndrome 26.54 9.65 21 151447 24692 50428964
Malignant neoplasm progression 26.05 9.65 110 151358 68014 50385642
Cerebral microhaemorrhage 25.78 9.65 10 151458 86 50453570
Infusion site haemorrhage 25.76 9.65 38 151430 2966 50450690
Food intolerance 25.56 9.65 34 151434 2410 50451246
Accidental exposure to product 25.51 9.65 19 151449 23038 50430618
Red blood cells urine 25.41 9.65 17 151451 496 50453160
Ocular hyperaemia 25.25 9.65 124 151344 20168 50433488
Pruritus 25.17 9.65 1063 150405 282505 50171151
Oxygen saturation decreased 25.05 9.65 332 151136 72916 50380740
Wrong technique in product usage process 24.88 9.65 84 151384 55426 50398230
Sinusitis 24.83 9.65 360 151108 170198 50283458
Intentional self-injury 24.37 9.65 20 151448 23092 50430564
Liver injury 24.30 9.65 23 151445 24783 50428873
Gallbladder cancer stage II 24.07 9.65 5 151463 0 50453656
Tongue carcinoma stage IV 24.07 9.65 5 151463 0 50453656
Conjunctivitis 24.05 9.65 104 151364 16041 50437615
Malaise 23.82 9.65 1230 150238 334302 50119354
Lymphoma 23.80 9.65 73 151395 9528 50444128
Depressed level of consciousness 23.71 9.65 78 151390 51875 50401781
Band neutrophil percentage increased 23.44 9.65 12 151456 209 50453447
Magnesium deficiency 23.41 9.65 16 151452 484 50453172
Reflux gastritis 22.93 9.65 20 151448 873 50452783
Polymenorrhoea 22.90 9.65 22 151446 1089 50452567
Leukaemia 22.75 9.65 39 151429 3460 50450196
Tooth erosion 22.47 9.65 15 151453 436 50453220
Gastrointestinal disorder 22.40 9.65 178 151290 94278 50359378
Bone erosion 22.31 9.65 4 151464 11683 50441973
Osteoporosis 22.16 9.65 65 151403 44814 50408842
Femur fracture 21.76 9.65 50 151418 37414 50416242
Lung carcinoma cell type unspecified stage 0 21.73 9.65 5 151463 3 50453653
Cervix carcinoma stage 0 21.68 9.65 13 151455 312 50453344
Renal impairment 21.65 9.65 135 151333 75526 50378130
Product use in unapproved indication 21.53 9.65 232 151236 115587 50338069
Nausea 21.44 9.65 2417 149051 702981 49750675
Deep vein thrombosis 21.39 9.65 130 151338 73174 50380482
COVID-19 21.33 9.65 70 151398 46592 50407064
Blister 21.18 9.65 159 151309 85259 50368397
Computerised tomogram thorax 21.17 9.65 10 151458 145 50453511
Adrenal gland cancer 21.10 9.65 7 151461 36 50453620
Synovial cyst 21.10 9.65 63 151405 8103 50445553
Bezoar 21.07 9.65 23 151445 1325 50452331
Neuroleptic malignant syndrome 20.84 9.65 4 151464 11126 50442530
Injection site erythema 20.78 9.65 135 151333 74801 50378855
Band neutrophil count increased 20.75 9.65 13 151455 338 50453318
Intentional product misuse 20.75 9.65 71 151397 46663 50406993
Lip swelling 20.75 9.65 136 151332 24600 50429056
Photophobia 20.74 9.65 94 151374 14793 50438863
Hyperkalaemia 20.72 9.65 74 151394 48015 50405641
Myelocyte count increased 20.69 9.65 13 151455 340 50453316
Mucosal inflammation 20.58 9.65 197 151271 39945 50413711
Therapy interrupted 20.56 9.65 18 151450 20134 50433522
Premenstrual syndrome 20.51 9.65 16 151452 596 50453060
Eyelid skin dryness 20.51 9.65 8 151460 70 50453586
Infusion site streaking 20.30 9.65 14 151454 430 50453226
Mast cell activation syndrome 20.22 9.65 13 151455 354 50453302
Tenderness 20.02 9.65 109 151359 18456 50435200
Excessive eye blinking 20.00 9.65 19 151449 927 50452729
Exposure via body fluid 19.88 9.65 14 151454 445 50453211
Urine oxalate increased 19.86 9.65 11 151457 226 50453430
Posterior reversible encephalopathy syndrome 19.72 9.65 10 151458 14918 50438738
Blood thyroid stimulating hormone increased 19.69 9.65 51 151417 6041 50447615
Cerebrovascular accident 19.53 9.65 185 151283 94495 50359161
Confusional state 19.52 9.65 416 151052 185512 50268144
Aplastic anaemia 19.50 9.65 59 151409 7644 50446012
Tonsillar haemorrhage 19.44 9.65 11 151457 236 50453420
Urethral cancer 19.32 9.65 5 151463 8 50453648
Rectal cancer metastatic 19.32 9.65 11 151457 239 50453417
Tachycardia 19.27 9.65 412 151056 99351 50354305
Gallbladder cancer stage I 19.26 9.65 4 151464 0 50453656
Laryngeal cancer stage I 19.26 9.65 4 151464 0 50453656
Small intestine carcinoma stage I 19.26 9.65 4 151464 0 50453656
Throat irritation 18.91 9.65 155 151313 30084 50423572
Adverse drug reaction 18.82 9.65 93 151375 55129 50398527
Dyspepsia 18.77 9.65 319 151149 73778 50379878
Nasal cavity cancer 18.74 9.65 6 151462 27 50453629
Defaecation urgency 18.67 9.65 33 151435 3000 50450656
Poisoning 18.51 9.65 7 151461 12422 50441234
Colon cancer stage III 18.51 9.65 8 151460 93 50453563
Sedation 18.48 9.65 40 151428 30570 50423086
Flank pain 18.41 9.65 83 151385 13032 50440624
Colon cancer stage II 18.38 9.65 7 151461 57 50453599
Anaphylactic shock 18.26 9.65 113 151355 20042 50433614
Rhabdomyolysis 18.22 9.65 58 151410 38969 50414687
Myelocyte percentage increased 18.12 9.65 10 151458 204 50453452
Ill-defined disorder 18.08 9.65 93 151375 54561 50399095
Red blood cell count increased 18.00 9.65 30 151438 2601 50451055
Systemic mastocytosis 17.88 9.65 9 151459 151 50453505
Monocyte count decreased 17.85 9.65 25 151443 1861 50451795
Sinus rhythm 17.79 9.65 15 151453 625 50453031
Chronic obstructive pulmonary disease 17.64 9.65 91 151377 53344 50400312
Tryptase increased 17.61 9.65 10 151458 216 50453440
Hot flush 17.59 9.65 206 151262 43963 50409693
Gastritis 17.47 9.65 163 151305 32820 50420836
Musculoskeletal stiffness 17.39 9.65 275 151193 128206 50325450
Fracture 17.21 9.65 15 151453 16818 50436838
Crystalluria 17.16 9.65 12 151456 377 50453279
Macular degeneration 17.06 9.65 11 151457 14377 50439279
Sickle cell trait 17.03 9.65 4 151464 3 50453653
Leukocyturia 16.66 9.65 18 151450 1025 50452631
Pharyngeal swelling 16.63 9.65 40 151428 4526 50449130
Thyroid stimulating immunoglobulin increased 16.46 9.65 7 151461 78 50453578
Anti-thyroid antibody positive 16.43 9.65 12 151456 404 50453252
Thrombocytopenia 16.37 9.65 276 151192 127397 50326259
Cardiac failure 16.36 9.65 147 151321 75893 50377763
Lipaemic index score 16.22 9.65 7 151461 81 50453575
Tuberculosis 16.19 9.65 5 151463 10078 50443578
Chronic spontaneous urticaria 16.06 9.65 13 151455 511 50453145
Panniculitis 16.04 9.65 3 151465 8500 50445156
Acute myeloid leukaemia 15.95 9.65 13 151455 15061 50438595
Peripheral coldness 15.90 9.65 67 151401 10216 50443440
Antinuclear antibody positive 15.84 9.65 48 151420 6224 50447432
Red cell distribution width decreased 15.80 9.65 18 151450 1087 50452569
Macroglossia 15.80 9.65 14 151454 624 50453032
Temperature intolerance 15.69 9.65 54 151414 7485 50446171
Delirium 15.65 9.65 60 151408 38132 50415524
Renal injury 15.64 9.65 59 151409 8552 50445104
Abdominal pain 15.54 9.65 860 150608 235368 50218288
Altered state of consciousness 15.53 9.65 26 151442 21884 50431772
End stage renal disease 15.53 9.65 45 151423 5692 50447964
Tubulointerstitial nephritis 15.53 9.65 88 151380 15123 50438533
Bradycardia 15.46 9.65 275 151193 64151 50389505
Paraesthesia oral 15.44 9.65 75 151393 12146 50441510
Nasopharyngeal cancer 15.36 9.65 5 151463 24 50453632
Glomerulonephritis chronic 15.34 9.65 8 151460 145 50453511
Nasal sinus cancer 15.19 9.65 5 151463 25 50453631
Neutrophil count decreased 15.07 9.65 207 151261 45819 50407837
Bronchopulmonary aspergillosis allergic 14.71 9.65 18 151450 1173 50452483
Carcinoid syndrome 14.61 9.65 7 151461 105 50453551
Paraesthesia 14.59 9.65 467 151001 119776 50333880
Hepatitis 14.50 9.65 47 151421 31406 50422250
Feeling jittery 14.46 9.65 69 151399 11091 50442565
Haemorrhage 14.45 9.65 97 151371 53344 50400312
Gallbladder cancer stage III 14.44 9.65 3 151465 0 50453656
Colorectal carcinoma stage 0 14.44 9.65 3 151465 0 50453656
Amastia 14.44 9.65 3 151465 0 50453656
C-kit gene mutation 14.44 9.65 3 151465 0 50453656
Intestinal metaplasia 14.44 9.65 3 151465 0 50453656
Tongue carcinoma stage III 14.44 9.65 3 151465 0 50453656
Endocrine neoplasm malignant 14.44 9.65 3 151465 0 50453656
Gallbladder cancer stage 0 14.44 9.65 3 151465 0 50453656
Prostate cancer stage IV 14.44 9.65 3 151465 0 50453656
Prostate cancer stage I 14.44 9.65 3 151465 0 50453656
Respiratory depth decreased 14.43 9.65 5 151463 30 50453626
Abortion induced 14.36 9.65 5 151463 9339 50444317
Liver function test abnormal 14.36 9.65 76 151392 44263 50409393
Swelling face 14.27 9.65 229 151239 52366 50401290
Hypoglycaemia 14.12 9.65 98 151370 53483 50400173
Pituitary apoplexy 14.04 9.65 7 151461 115 50453541
Sleep disorder 14.02 9.65 107 151361 57176 50396480
Device difficult to use 14.02 9.65 6 151462 9880 50443776
Lichen sclerosus 14.01 9.65 16 151452 969 50452687
Endometrial cancer stage II 14.00 9.65 4 151464 11 50453645
Dysgeusia 13.98 9.65 178 151290 38738 50414918
Incontinence 13.87 9.65 63 151405 9922 50443734
Barotrauma 13.84 9.65 8 151460 179 50453477
Encephalopathy 13.79 9.65 53 151415 33658 50419998
Urethral pain 13.76 9.65 10 151458 334 50453322
Electrocardiogram QT prolonged 13.73 9.65 225 151243 51661 50401995
Colon cancer 13.73 9.65 57 151411 8634 50445022
Sopor 13.71 9.65 24 151444 19855 50433801
Heart rate increased 13.64 9.65 315 151153 76935 50376721
Dyspnoea 13.54 9.65 1853 149615 545755 49907901
Product dose omission issue 13.53 9.65 433 151035 183405 50270251
Atrioventricular block second degree 13.49 9.65 32 151436 3589 50450067
Pulseless electrical activity 13.37 9.65 48 151420 6793 50446863
Post-traumatic neck syndrome 13.37 9.65 22 151446 1888 50451768
Nasopharyngitis 13.36 9.65 458 151010 192469 50261187
Bilirubin urine present 13.36 9.65 6 151462 77 50453579
Coronary artery disease 13.31 9.65 45 151423 29681 50423975
Renal pain 13.26 9.65 42 151426 5577 50448079
Feeling cold 13.24 9.65 102 151366 19429 50434227
Disease recurrence 13.18 9.65 25 151443 20056 50433600
Gastrointestinal haemorrhage 13.17 9.65 148 151320 73173 50380483
Device dislocation 13.13 9.65 28 151440 21518 50432138
Allergy to chemicals 13.12 9.65 18 151450 1314 50452342
Lupus-like syndrome 13.08 9.65 6 151462 9485 50444171
Hepatic cytolysis 13.05 9.65 4 151464 8099 50445557
Hepatic failure 13.04 9.65 51 151417 32232 50421424
Specific gravity urine increased 12.98 9.65 8 151460 202 50453454
Mean cell volume decreased 12.94 9.65 26 151442 2603 50451053
Drug interaction 12.88 9.65 478 150990 199143 50254513
C-reactive protein increased 12.82 9.65 132 151336 66342 50387314
Cough 12.81 9.65 862 150606 240402 50213254
Myelosuppression 12.70 9.65 13 151455 13504 50440152
Oral pruritus 12.66 9.65 20 151448 1658 50451998
Pulpitis dental 12.65 9.65 14 151454 819 50452837
Food aversion 12.57 9.65 11 151457 482 50453174
Trichoglossia 12.57 9.65 8 151460 214 50453442
Haematocrit decreased 12.57 9.65 160 151308 34816 50418840
Petechiae 12.52 9.65 72 151396 12440 50441216
Blood parathyroid hormone decreased 12.42 9.65 3 151465 7111 50446545
Cerebral infarction 12.41 9.65 29 151439 21575 50432081
Cholestasis 12.39 9.65 37 151431 25364 50428292
Palmar erythema 12.31 9.65 19 151449 1544 50452112
Drug tolerance decreased 12.30 9.65 6 151462 9154 50444502
Herpes zoster 12.28 9.65 144 151324 70642 50383014
Diabetes mellitus 12.28 9.65 91 151377 48942 50404714
Mean cell haemoglobin increased 12.20 9.65 23 151445 2197 50451459
Aphonia 12.16 9.65 54 151414 8424 50445232
Lymphorrhoea 12.15 9.65 5 151463 51 50453605
Allergy to metals 12.12 9.65 11 151457 506 50453150
Urobilinogen urine increased 12.06 9.65 8 151460 230 50453426
Colon cancer stage IV 12.01 9.65 6 151462 99 50453557
Respiratory depression 11.92 9.65 11 151457 11999 50441657
Wheezing 11.90 9.65 256 151212 61791 50391865
Lip and/or oral cavity cancer 11.87 9.65 9 151459 321 50453335
Cyanosis 11.85 9.65 82 151386 15102 50438554
Pregnancy 11.78 9.65 47 151421 29530 50424126
Type 2 diabetes mellitus 11.65 9.65 58 151410 34317 50419339
Pregnancy on contraceptive 11.57 9.65 15 151453 1037 50452619
Subdural haematoma 11.56 9.65 13 151455 12934 50440722
Vomiting 11.49 9.65 1560 149908 459198 49994458
Arthralgia 11.48 9.65 1144 150324 437558 50016098
Bruxism 11.47 9.65 27 151441 3013 50450643
Mean cell haemoglobin concentration decreased 11.45 9.65 26 151442 2833 50450823
Sedation complication 11.39 9.65 6 151462 8760 50444896
Dystrophic calcification 11.35 9.65 6 151462 112 50453544
Ulcerative gastritis 11.28 9.65 4 151464 26 50453630
Pericardial effusion 11.27 9.65 39 151429 25550 50428106
Malignant neoplasm of renal pelvis 11.15 9.65 4 151464 27 50453629
Pneumonia 11.15 9.65 978 150490 377423 50076233
Thyroid stimulating immunoglobulin 11.14 9.65 5 151463 64 50453592
Intraductal proliferative breast lesion 11.13 9.65 24 151444 2526 50451130
Drug level increased 11.11 9.65 97 151371 19171 50434485
Sneezing 11.05 9.65 76 151392 13968 50439688
Endocrine ophthalmopathy 10.90 9.65 9 151459 364 50453292
Atrioventricular block first degree 10.86 9.65 42 151426 6159 50447497
Retinal depigmentation 10.84 9.65 8 151460 274 50453382
Enthesopathy 10.80 9.65 4 151464 7189 50446467
Sensation of foreign body 10.78 9.65 31 151437 3905 50449751
Breast cancer in situ 10.72 9.65 17 151451 1414 50452242
Menstruation delayed 10.72 9.65 17 151451 1414 50452242
Agitation 10.71 9.65 105 151363 53279 50400377
Migraine 10.65 9.65 298 151170 74982 50378674
Osteoarthritis 10.61 9.65 143 151325 68463 50385193
Cardiomyopathy 10.59 9.65 19 151449 15567 50438089
Lipohypertrophy 10.54 9.65 11 151457 602 50453054
Renal transplant failure 10.54 9.65 11 151457 602 50453054
Creatinine renal clearance decreased 10.53 9.65 12 151456 11869 50441787
Right atrial dilatation 10.51 9.65 11 151457 604 50453052
Retinal degeneration 10.48 9.65 12 151456 729 50452927
Breast calcifications 10.47 9.65 15 151453 1140 50452516
Psychotic disorder 10.47 9.65 32 151436 21780 50431876
Respiratory failure 10.46 9.65 201 151267 90980 50362676
Infusion site extravasation 10.44 9.65 45 151423 6931 50446725
Cardio-respiratory arrest 10.40 9.65 107 151361 53785 50399871
International normalised ratio increased 10.37 9.65 81 151387 43071 50410585
Feeling abnormal 10.34 9.65 467 151001 125025 50328631
Bone marrow failure 10.31 9.65 45 151423 27579 50426077
Pulmonary fibrosis 10.26 9.65 38 151430 24399 50429257
Nail avulsion 10.23 9.65 6 151462 138 50453518
Parkinsonism 10.17 9.65 7 151461 8840 50444816
Fumbling 10.16 9.65 6 151462 140 50453516
Rebound acid hypersecretion 10.14 9.65 8 151460 303 50453353
Aggression 10.12 9.65 31 151437 21085 50432571
Injection site pruritus 10.12 9.65 75 151393 40336 50413320
Blood cholesterol increased 10.10 9.65 111 151357 55104 50398552
Tri-iodothyronine free abnormal 10.06 9.65 4 151464 37 50453619
Atrioventricular dissociation 10.03 9.65 7 151461 219 50453437
Paranasal sinus inflammation 10.03 9.65 9 151459 408 50453248
Basal cell carcinoma 10.02 9.65 36 151432 23320 50430336
Nystagmus 10.02 9.65 38 151430 5523 50448133
Blood creatine phosphokinase MM increased 9.97 9.65 4 151464 38 50453618
Agranulocytosis 9.88 9.65 32 151436 21389 50432267
Abdominal distension 9.87 9.65 287 151181 72616 50381040
Malignant peritoneal neoplasm 9.85 9.65 11 151457 650 50453006
Flatulence 9.85 9.65 133 151335 29325 50424331
Localised infection 9.83 9.65 41 151427 25444 50428212
Premature delivery 9.81 9.65 37 151431 23626 50430030
Peripheral swelling 9.80 9.65 510 150958 205426 50248230
Injection site haemorrhage 9.77 9.65 32 151436 21314 50432342
Metabolic acidosis 9.75 9.65 72 151396 38753 50414903
Taste disorder 9.75 9.65 50 151418 8274 50445382
Joint injury 9.74 9.65 33 151435 21756 50431900
Generalised tonic-clonic seizure 9.74 9.65 43 151425 26267 50427389
Spinal fracture 9.69 9.65 20 151448 15553 50438103

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
Prostate cancer 6480.33 10.08 2524 83679 23003 29465321
Bladder cancer 4596.80 10.08 1541 84662 8586 29479738
Oesophageal carcinoma 4232.96 10.08 1201 85002 3346 29484978
Renal cancer 3708.68 10.08 1078 85125 3363 29484961
Colorectal cancer 3111.72 10.08 782 85421 1085 29487239
Prostate cancer stage I 2892.08 10.08 604 85599 35 29488289
Prostate cancer stage IV 2387.97 10.08 518 85685 137 29488187
Colorectal cancer stage III 2285.03 10.08 474 85729 11 29488313
Prostate cancer stage II 2038.73 10.08 459 85744 228 29488096
Colorectal cancer stage IV 2029.34 10.08 419 85784 0 29488324
Prostate cancer stage III 1796.39 10.08 378 85825 36 29488288
Testis cancer 1645.78 10.08 408 85795 512 29487812
Hepatic cancer stage IV 1588.43 10.08 328 85875 0 29488324
Renal cancer stage IV 1522.47 10.08 315 85888 3 29488321
Renal cancer stage I 1434.42 10.08 300 85903 19 29488305
Colorectal cancer stage II 1307.46 10.08 270 85933 0 29488324
Renal cancer stage III 1041.95 10.08 217 85986 9 29488315
Pancreatic carcinoma stage IV 974.94 10.08 218 85985 98 29488226
Gastric cancer stage IV 913.22 10.08 191 86012 12 29488312
Gastric cancer 903.15 10.08 384 85819 4410 29483914
Bladder cancer stage II 870.78 10.08 183 86020 16 29488308
Gastrointestinal carcinoma 867.62 10.08 262 85941 962 29487362
Renal cancer stage II 857.02 10.08 177 86026 0 29488324
Bladder cancer stage IV 857.02 10.08 177 86026 0 29488324
Bladder cancer stage III 852.17 10.08 176 86027 0 29488324
Colorectal cancer stage I 827.96 10.08 171 86032 0 29488324
Hepatic cancer 814.88 10.08 391 85812 6065 29482259
Lung carcinoma cell type unspecified stage IV 753.89 10.08 194 86009 313 29488011
Haematological malignancy 735.20 10.08 175 86028 158 29488166
Pancreatic carcinoma 481.69 10.08 285 85918 6865 29481459
Skin cancer 449.59 10.08 290 85913 8178 29480146
Prostate cancer stage 0 426.04 10.08 88 86115 0 29488324
Brain neoplasm malignant 370.78 10.08 114 86089 451 29487873
Thyroid cancer 352.22 10.08 137 86066 1225 29487099
Gastric cancer stage III 348.57 10.08 72 86131 0 29488324
Neoplasm malignant 316.89 10.08 314 85889 16611 29471713
Lung neoplasm malignant 298.20 10.08 282 85921 14075 29474249
Gastric cancer stage II 295.32 10.08 61 86142 0 29488324
Throat cancer 284.42 10.08 102 86101 709 29487615
Pancreatic carcinoma stage II 261.42 10.08 54 86149 0 29488324
Lung carcinoma cell type unspecified stage I 226.74 10.08 48 86155 6 29488318
Gastric cancer stage I 217.85 10.08 45 86158 0 29488324
Incorrect dose administered 214.50 10.08 362 85841 32622 29455702
Pancreatic carcinoma stage III 210.51 10.08 45 86158 8 29488316
Lung carcinoma cell type unspecified stage III 188.80 10.08 39 86164 0 29488324
Drug ineffective 174.23 10.08 515 85688 362655 29125669
Prostatic disorder 167.95 10.08 105 86098 2798 29485526
Appendix cancer 166.57 10.08 35 86168 3 29488321
Hepatic cancer stage III 164.60 10.08 34 86169 0 29488324
Lung carcinoma cell type unspecified stage II 145.23 10.08 30 86173 0 29488324
Thyroid cancer stage I 145.23 10.08 30 86173 0 29488324
Toxicity to various agents 140.69 10.08 180 86023 173481 29314843
Thyroid cancer stage IV 135.55 10.08 28 86175 0 29488324
Pancreatic carcinoma stage I 125.87 10.08 26 86177 0 29488324
Death 122.87 10.08 547 85656 341537 29146787
Hepatic cancer stage II 121.03 10.08 25 86178 0 29488324
Small intestine carcinoma stage IV 121.03 10.08 25 86178 0 29488324
Completed suicide 117.60 10.08 58 86145 90188 29398136
Thyroid cancer stage III 111.34 10.08 23 86180 0 29488324
Hepatic cancer stage I 111.34 10.08 23 86180 0 29488324
Small intestine carcinoma 109.79 10.08 45 86158 467 29487857
Drug abuse 97.22 10.08 56 86147 79827 29408497
Bladder cancer stage I, with cancer in situ 96.82 10.08 20 86183 0 29488324
Thyroid cancer stage II 96.82 10.08 20 86183 0 29488324
Bone cancer 86.20 10.08 50 86153 1158 29487166
Off label use 78.67 10.08 534 85669 300266 29188058
Breast cancer stage I 77.46 10.08 16 86187 0 29488324
Uterine cancer 77.46 10.08 16 86187 0 29488324
Breast cancer male 77.23 10.08 30 86173 267 29488057
Cardiac failure 59.23 10.08 87 86116 79200 29409124
Breast cancer stage II 58.09 10.08 12 86191 0 29488324
Tongue carcinoma stage III 58.09 10.08 12 86191 0 29488324
Tongue carcinoma stage IV 58.09 10.08 12 86191 0 29488324
Disease progression 56.16 10.08 420 85783 81496 29406828
Anaphylactic reaction 54.78 10.08 191 86012 27382 29460942
Chronic kidney disease 54.09 10.08 230 85973 36186 29452138
Gallbladder cancer 53.76 10.08 21 86182 190 29488134
COVID-19 53.54 10.08 19 86184 35995 29452329
Small intestine carcinoma stage I 53.25 10.08 11 86192 0 29488324
Small intestine carcinoma stage III 53.25 10.08 11 86192 0 29488324
Gallbladder cancer stage IV 53.25 10.08 11 86192 0 29488324
Leukaemia 50.66 10.08 59 86144 3751 29484573
Clear cell renal cell carcinoma 49.55 10.08 33 86170 982 29487342
Drug intolerance 49.43 10.08 41 86162 48338 29439986
Gastric cancer stage 0 49.32 10.08 12 86191 13 29488311
Blood cholesterol 48.92 10.08 19 86184 169 29488155
Breast cancer stage III 48.41 10.08 10 86193 0 29488324
Victim of child abuse 47.46 10.08 30 86173 815 29487509
Suicide attempt 47.39 10.08 20 86183 34090 29454234
Adrenal gland cancer 46.76 10.08 12 86191 19 29488305
Colon cancer stage IV 46.46 10.08 17 86186 126 29488198
Lymphoma 46.37 10.08 94 86109 9734 29478590
General physical health deterioration 46.06 10.08 150 86053 102707 29385617
Nasal cavity cancer 45.67 10.08 17 86186 133 29488191
Gastrooesophageal reflux disease 43.77 10.08 195 86008 31301 29457023
Pancreatic carcinoma stage 0 43.57 10.08 9 86194 0 29488324
Drug resistance 42.72 10.08 6 86197 21534 29466790
Lymphocyte percentage decreased 36.95 10.08 37 86166 1980 29486344
Rheumatoid arthritis 33.14 10.08 27 86176 32125 29456199
Multiple organ dysfunction syndrome 32.63 10.08 86 86117 63030 29425294
Crystal urine present 31.26 10.08 18 86185 411 29487913
Treatment failure 31.18 10.08 37 86166 36902 29451422
Anaemia 31.12 10.08 406 85797 200545 29287779
Tongue neoplasm malignant stage unspecified 30.46 10.08 20 86183 581 29487743
Colon cancer stage II 29.85 10.08 10 86193 55 29488269
Neutrophil percentage increased 29.59 10.08 31 86172 1750 29486574
Small intestine carcinoma stage II 29.05 10.08 6 86197 0 29488324
Tongue carcinoma stage II 29.05 10.08 6 86197 0 29488324
Gallbladder cancer stage III 29.05 10.08 6 86197 0 29488324
Tonsil cancer 28.87 10.08 23 86180 908 29487416
Coma 28.75 10.08 44 86159 39406 29448918
Infective pulmonary exacerbation of cystic fibrosis 28.65 10.08 59 86144 6177 29482147
Colon cancer stage I 28.13 10.08 7 86196 9 29488315
Intentional overdose 28.05 10.08 43 86160 38485 29449839
Neuroendocrine carcinoma 27.95 10.08 16 86187 361 29487963
Laryngeal cancer 27.88 10.08 20 86183 673 29487651
Fall 27.77 10.08 357 85846 176821 29311503
Oroantral fistula 27.34 10.08 13 86190 197 29488127
Cutaneous lupus erythematosus 26.99 10.08 20 86183 708 29487616
Joint swelling 26.90 10.08 66 86137 49564 29438760
Cardiac failure congestive 26.38 10.08 124 86079 76457 29411867
Oesophageal pain 26.27 10.08 20 86183 738 29487586
Arthralgia 25.88 10.08 271 85932 139346 29348978
Lip and/or oral cavity cancer 25.75 10.08 14 86189 285 29488039
Kounis syndrome 25.45 10.08 29 86174 1800 29486524
Interstitial lung disease 25.25 10.08 85 86118 57633 29430691
Pneumopericardium 25.08 10.08 10 86193 96 29488228
Drug interaction 24.92 10.08 415 85788 196970 29291354
Sepsis 24.82 10.08 281 85922 142401 29345923
Malignant neoplasm progression 24.62 10.08 121 86082 73738 29414586
Oesophageal carcinoma stage 0 24.21 10.08 5 86198 0 29488324
Breast cancer stage IV 24.21 10.08 5 86198 0 29488324
Tongue carcinoma stage I 24.21 10.08 5 86198 0 29488324
Rectal cancer stage II 24.21 10.08 5 86198 0 29488324
Head and neck cancer stage IV 24.21 10.08 5 86198 0 29488324
Laryngeal cancer stage I 24.21 10.08 5 86198 0 29488324
Drug level fluctuating 24.18 10.08 16 86187 471 29487853
Oesophageal polyp 23.88 10.08 8 86195 44 29488280
Lymphoproliferative disorder 23.86 10.08 33 86170 2494 29485830
Urine abnormality 23.81 10.08 27 86176 1667 29486657
Overdose 23.69 10.08 136 86067 79683 29408641
Tooth deposit 23.48 10.08 9 86194 77 29488247
Monocyte percentage increased 23.00 10.08 20 86183 893 29487431
Dyspepsia 22.65 10.08 158 86045 29967 29458357
Ureteric cancer 22.60 10.08 11 86192 176 29488148
Myocardial infarction 22.56 10.08 209 85994 110087 29378237
Laryngeal cancer stage IV 22.49 10.08 6 86197 12 29488312
Product use in unapproved indication 22.20 10.08 155 86048 86720 29401604
Injection site pain 21.94 10.08 38 86165 32408 29455916
Specific gravity urine increased 21.93 10.08 10 86193 137 29488187
Diarrhoea 21.92 10.08 772 85431 331926 29156398
Pancytopenia 21.44 10.08 148 86055 83020 29405304
Lung carcinoma cell type unspecified stage 0 21.13 10.08 7 86196 37 29488287
Condition aggravated 21.02 10.08 300 85903 145995 29342329
Epidural lipomatosis 20.85 10.08 17 86186 694 29487630
Oedema peripheral 20.85 10.08 197 86006 103360 29384964
White blood cells urine positive 20.52 10.08 21 86182 1153 29487171
Brain cancer metastatic 20.14 10.08 8 86195 76 29488248
Lactic acidosis 19.94 10.08 36 86167 30211 29458113
Gingival atrophy 19.85 10.08 7 86196 46 29488278
Abnormal behaviour 19.69 10.08 23 86180 23104 29465220
End stage renal disease 19.69 10.08 58 86145 7606 29480718
Total lung capacity abnormal 19.56 10.08 9 86194 126 29488198
Synovitis 19.46 10.08 4 86199 10886 29477438
Urine leukocyte esterase positive 19.37 10.08 13 86190 392 29487932
Urticaria 19.37 10.08 244 85959 54416 29433908
Tongue cancer metastatic 19.36 10.08 4 86199 0 29488324
Bile duct cancer stage IV 19.36 10.08 4 86199 0 29488324
Bladder cancer stage I, without cancer in situ 19.36 10.08 4 86199 0 29488324
Thyroid cancer stage 0 19.36 10.08 4 86199 0 29488324
Ovarian cancer 19.36 10.08 4 86199 0 29488324
Colorectal carcinoma stage 0 19.36 10.08 4 86199 0 29488324
Gallbladder cancer stage I 19.36 10.08 4 86199 0 29488324
Laryngeal cancer stage III 19.08 10.08 5 86198 9 29488315
Prostatomegaly 18.99 10.08 42 86161 4619 29483705
Loss of personal independence in daily activities 18.90 10.08 28 86175 25412 29462912
Lymphocytic infiltration 18.88 10.08 15 86188 590 29487734
Arthropathy 18.82 10.08 21 86182 21533 29466791
Gastritis 18.78 10.08 109 86094 19408 29468916
Peripheral swelling 18.70 10.08 109 86094 63630 29424694
Neuroleptic malignant syndrome 18.68 10.08 12 86191 16136 29472188
Therapeutic product effect decreased 18.57 10.08 36 86167 29415 29458909
Shock 18.53 10.08 21 86182 21383 29466941
Intentional product use issue 18.30 10.08 63 86140 42435 29445889
Sleep terror 18.20 10.08 16 86187 725 29487599
Renal cell carcinoma stage III 18.12 10.08 5 86198 12 29488312
Encephalopathy 17.85 10.08 40 86163 31003 29457321
Acute kidney injury 17.79 10.08 614 85589 264653 29223671
Hepatic function abnormal 17.73 10.08 57 86146 39202 29449122
Sopor 17.61 10.08 5 86198 10929 29477395
Haematopoietic stem cell mobilisation 17.44 10.08 9 86194 164 29488160
Cerebrovascular accident 17.38 10.08 142 86061 76769 29411555
Accidental exposure to product 17.17 10.08 5 86198 10748 29477576
Reversible airways obstruction 16.88 10.08 10 86193 241 29488083
Rhabdomyolysis 16.78 10.08 106 86097 60702 29427622
Pain in extremity 16.73 10.08 224 85979 110209 29378115
Altered state of consciousness 16.70 10.08 20 86183 19869 29468455
Lymphocele 16.67 10.08 20 86183 1312 29487012
Aplastic anaemia 16.66 10.08 54 86149 7456 29480868
Eosinophil percentage increased 16.63 10.08 13 86190 499 29487825
Paraneoplastic rash 16.48 10.08 7 86196 80 29488244
Cardio-respiratory arrest 16.23 10.08 84 86119 50517 29437807
Urine analysis abnormal 16.05 10.08 23 86180 1797 29486527
Pain 16.00 10.08 379 85824 171053 29317271
Juvenile idiopathic arthritis 15.94 10.08 20 86183 1374 29486950
Lip swelling 15.87 10.08 75 86128 12335 29475989
Airway remodelling 15.85 10.08 8 86195 139 29488185
Nasopharyngeal cancer stage IV 15.72 10.08 4 86199 6 29488318
Bladder mass 15.57 10.08 9 86194 207 29488117
Psychotic disorder 15.51 10.08 22 86181 20332 29467992
Foetal hypokinesia 15.41 10.08 11 86192 367 29487957
Pneumonia 15.15 10.08 771 85432 319401 29168923
Anorectal discomfort 15.07 10.08 21 86182 1598 29486726
Atrial fibrillation 15.04 10.08 217 85986 105429 29382895
Bacterial test 15.02 10.08 8 86195 156 29488168
Renal impairment 15.00 10.08 158 86045 81175 29407149
Band neutrophil percentage increased 14.84 10.08 7 86196 104 29488220
Epiglottic cancer 14.52 10.08 3 86200 0 29488324
Anal cancer stage II 14.52 10.08 3 86200 0 29488324
Nasopharyngeal cancer stage III 14.52 10.08 3 86200 0 29488324
Salivary gland cancer stage I 14.52 10.08 3 86200 0 29488324
Oesophageal adenocarcinoma stage IV 14.52 10.08 3 86200 0 29488324
Laryngeal cancer stage II 14.52 10.08 3 86200 0 29488324
B-cell lymphoma stage III 14.52 10.08 3 86200 0 29488324
Malignant melanoma stage III 14.52 10.08 3 86200 0 29488324
Pathogen resistance 14.46 10.08 3 86200 8113 29480211
Accidental overdose 14.44 10.08 18 86185 17575 29470749
Iris adhesions 14.42 10.08 9 86194 239 29488085
Optic discs blurred 14.17 10.08 6 86197 68 29488256
Respiratory failure 14.00 10.08 199 86004 96932 29391392
Benign neoplasm of bladder 13.85 10.08 4 86199 12 29488312
Intentional product misuse 13.85 10.08 53 86150 34608 29453716
Fatigue 13.85 10.08 769 85434 316052 29172272
Arrhythmia 13.76 10.08 46 86157 31267 29457057
Forced vital capacity decreased 13.75 10.08 13 86190 648 29487676
Long QT syndrome 13.63 10.08 24 86179 2234 29486090
Ischaemic stroke 13.48 10.08 16 86187 15961 29472363
Aspergillus infection 13.46 10.08 7 86196 10574 29477750
Intentional self-injury 13.43 10.08 10 86193 12451 29475873
Primary biliary cholangitis 13.30 10.08 7 86196 133 29488191
Cerebral haemorrhage 13.25 10.08 47 86156 31379 29456945
Psoriatic arthropathy 13.17 10.08 14 86189 14677 29473647
Open angle glaucoma 13.16 10.08 7 86196 136 29488188
Hypersensitivity 13.13 10.08 222 85981 52681 29435643
Genitalia external ambiguous 13.07 10.08 8 86195 205 29488119
Sarcoma 13.07 10.08 10 86193 372 29487952
Bacterial test positive 13.05 10.08 27 86176 2836 29485488
Unevaluable event 13.02 10.08 44 86159 29807 29458517
Pulpitis dental 13.00 10.08 10 86193 375 29487949
Myocardial oedema 12.93 10.08 8 86195 209 29488115
HIV associated nephropathy 12.91 10.08 9 86194 289 29488035
Renal mass 12.90 10.08 19 86184 1521 29486803
Sense of oppression 12.87 10.08 11 86192 480 29487844
Myelodysplastic syndrome 12.81 10.08 20 86183 17774 29470550
Blood creatine phosphokinase increased 12.73 10.08 68 86135 40576 29447748
Liver disorder 12.73 10.08 40 86163 27709 29460615
Mitral valve incompetence 12.69 10.08 12 86191 13281 29475043
Spinal cord neoplasm 12.68 10.08 7 86196 147 29488177
Hepatic enzyme increased 12.67 10.08 53 86150 33746 29454578
Bronchiolitis 12.58 10.08 26 86177 2729 29485595
Ear discomfort 12.52 10.08 23 86180 2214 29486110
Renal cell carcinoma 12.50 10.08 36 86167 4660 29483664
Chronic lymphocytic leukaemia stage 1 12.45 10.08 3 86200 3 29488321
Transaminases increased 12.38 10.08 30 86173 22632 29465692
Rebound acid hypersecretion 12.38 10.08 6 86197 95 29488229
Tubulointerstitial nephritis 12.37 10.08 91 86112 17552 29470772
Erythema 12.34 10.08 298 85905 75308 29413016
Regurgitation 12.24 10.08 17 86186 1290 29487034
Acute on chronic liver failure 12.16 10.08 6 86197 99 29488225
Foetal exposure during pregnancy 12.15 10.08 54 86149 33813 29454511
Band neutrophil count increased 12.04 10.08 8 86195 237 29488087
Bone metabolism disorder 11.98 10.08 8 86195 239 29488085
Gastrointestinal stromal tumour 11.94 10.08 13 86190 767 29487557
High frequency ablation 11.81 10.08 7 86196 169 29488155
Breast cancer 11.75 10.08 8 86195 247 29488077
Red blood cells urine positive 11.72 10.08 19 86184 1654 29486670
Myelosuppression 11.71 10.08 11 86192 12216 29476108
Haematoma 11.71 10.08 32 86171 23180 29465144
Ocular discomfort 11.58 10.08 19 86184 1670 29486654
Intensive care unit acquired weakness 11.54 10.08 14 86189 929 29487395
Bronchospasm 11.52 10.08 57 86146 9552 29478772
Drug therapeutic incompatibility 11.45 10.08 6 86197 113 29488211
Bacillus bacteraemia 11.34 10.08 5 86198 63 29488261
Extrapyramidal disorder 11.28 10.08 9 86194 10822 29477502
Congenital bladder anomaly 11.26 10.08 8 86195 265 29488059
Myalgia 11.25 10.08 150 86053 73869 29414455
Incorrect route of product administration 11.22 10.08 9 86194 10792 29477532
Body temperature decreased 11.22 10.08 61 86142 10603 29477721
Blood pressure decreased 11.19 10.08 82 86121 45395 29442929
Shock haemorrhagic 11.18 10.08 7 86196 9544 29478780
Polyneuropathy 11.13 10.08 67 86136 12085 29476239
Musculoskeletal pain 11.10 10.08 45 86158 28908 29459416
Lactobacillus test positive 11.01 10.08 4 86199 29 29488295
Delusion of replacement 11.00 10.08 6 86197 123 29488201
Subcutaneous emphysema 10.97 10.08 14 86189 978 29487346
Cervicobrachial syndrome 10.95 10.08 8 86195 277 29488047
Contraindicated product administered 10.94 10.08 23 86180 18243 29470081
Septic shock 10.94 10.08 123 86080 62437 29425887
Hepatocellular injury 10.93 10.08 29 86174 21214 29467110
Periodontal disease 10.83 10.08 12 86191 722 29487602
Clostridium difficile infection 10.82 10.08 19 86184 16122 29472202
Neuropathy peripheral 10.77 10.08 144 86059 70883 29417441
Neutropenia 10.72 10.08 297 85906 131414 29356910
Porphyria acute 10.70 10.08 7 86196 202 29488122
Gait disturbance 10.66 10.08 150 86053 73199 29415125
Haemochromatosis 10.63 10.08 14 86189 1009 29487315
Drug hypersensitivity 10.63 10.08 138 86065 68268 29420056
Red cell distribution width increased 10.58 10.08 34 86169 4673 29483651
Parkinsonism 10.54 10.08 4 86199 7274 29481050
Ejection fraction decreased 10.54 10.08 19 86184 15959 29472365
Carcinoid tumour 10.52 10.08 7 86196 208 29488116
Nasopharyngeal cancer 10.50 10.08 6 86197 135 29488189
Pyrexia 10.47 10.08 710 85493 286912 29201412
Oesophagitis 10.46 10.08 65 86138 11858 29476466
Depression 10.39 10.08 180 86023 84967 29403357
Necrotising retinitis 10.39 10.08 12 86191 756 29487568
Urine ketone body present 10.37 10.08 14 86189 1034 29487290
Urethral cancer 10.36 10.08 4 86199 35 29488289
Head and neck cancer 10.35 10.08 8 86195 302 29488022
Tuberculosis 10.35 10.08 4 86199 7192 29481132
Myocarditis 10.33 10.08 10 86193 10946 29477378
Toxic skin eruption 10.30 10.08 8 86195 9749 29478575
Adenotonsillectomy 10.26 10.08 4 86199 36 29488288
Drug ineffective for unapproved indication 10.21 10.08 16 86187 14198 29474126
Hypoglycaemia 10.14 10.08 91 86112 48255 29440069
Tremor 10.13 10.08 152 86051 73386 29414938
Bladder cancer recurrent 10.08 10.08 8 86195 314 29488010

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
Prostate cancer 6812.04 9.51 2511 203466 17284 64275471
Bladder cancer 5898.69 9.51 1942 204035 9032 64283723
Colorectal cancer 5636.75 9.51 1429 204548 1792 64290963
Oesophageal carcinoma 5635.35 9.51 1548 204429 3195 64289560
Renal cancer 5518.60 9.51 1653 204324 5222 64287533
Breast cancer stage I 4910.93 9.51 1133 204844 591 64292164
Breast cancer stage II 4257.30 9.51 977 205000 475 64292280
Colorectal cancer stage III 3914.12 9.51 826 205151 11 64292744
Colorectal cancer stage IV 3665.32 9.51 772 205205 3 64292752
Prostate cancer stage I 2848.20 9.51 606 205371 32 64292723
Hepatic cancer stage IV 2751.28 9.51 584 205393 24 64292731
Breast cancer female 2640.42 9.51 878 205099 4225 64288530
Prostate cancer stage IV 2389.20 9.51 521 205456 94 64292661
Colorectal cancer stage II 2332.75 9.51 491 205486 0 64292755
Renal cancer stage IV 2178.78 9.51 471 205506 63 64292692
Renal cancer stage I 2158.31 9.51 459 205518 23 64292732
Prostate cancer stage II 2034.81 9.51 458 205519 166 64292589
Pancreatic carcinoma stage IV 1966.08 9.51 439 205538 138 64292617
Prostate cancer stage III 1783.03 9.51 380 205597 23 64292732
Breast cancer stage III 1742.13 9.51 559 205418 2346 64290409
Testis cancer 1690.49 9.51 408 205569 343 64292412
Uterine cancer 1661.74 9.51 539 205438 2359 64290396
Gastric cancer 1617.93 9.51 652 205325 5841 64286914
Renal cancer stage III 1527.45 9.51 324 205653 12 64292743
Colorectal cancer stage I 1505.94 9.51 317 205660 0 64292755
Gastric cancer stage IV 1503.70 9.51 325 205652 43 64292712
Lung carcinoma cell type unspecified stage IV 1486.37 9.51 384 205593 546 64292209
Hepatic cancer 1455.69 9.51 629 205348 6819 64285936
Renal cancer stage II 1396.66 9.51 294 205683 0 64292755
Gastrointestinal carcinoma 1383.33 9.51 430 205547 1587 64291168
Breast cancer stage IV 1308.43 9.51 313 205664 242 64292513
Haematological malignancy 1228.51 9.51 298 205679 262 64292493
Bladder cancer stage IV 1194.98 9.51 253 205724 7 64292748
Thyroid cancer 1167.05 9.51 450 205527 3541 64289214
Bladder cancer stage II 1137.01 9.51 241 205736 8 64292747
Bladder cancer stage III 1054.58 9.51 222 205755 0 64292755
Pancreatic carcinoma 918.06 9.51 510 205467 9863 64282892
Skin cancer 695.61 9.51 449 205528 11525 64281230
Brain neoplasm malignant 680.83 9.51 220 205757 948 64291807
Lung neoplasm malignant 586.90 9.51 512 205465 20936 64271819
Gastric cancer stage III 579.52 9.51 122 205855 0 64292755
Neoplasm malignant 578.39 9.51 540 205437 24148 64268607
Thyroid cancer stage I 513.01 9.51 108 205869 0 64292755
Pancreatic carcinoma stage II 427.50 9.51 90 205887 0 64292755
Lung carcinoma cell type unspecified stage I 419.44 9.51 101 205876 83 64292672
Gastric cancer stage II 418.00 9.51 88 205889 0 64292755
Prostate cancer stage 0 413.25 9.51 87 205890 0 64292755
Pancreatic carcinoma stage III 410.31 9.51 87 205890 3 64292752
Gastric cancer stage I 408.50 9.51 86 205891 0 64292755
Lung carcinoma cell type unspecified stage III 378.64 9.51 92 205885 82 64292673
Drug ineffective 373.93 9.51 1404 204573 838843 63453912
Toxicity to various agents 371.64 9.51 368 205609 363145 63929610
Completed suicide 369.02 9.51 128 205849 224286 64068469
Lung carcinoma cell type unspecified stage II 343.04 9.51 74 205903 9 64292746
Throat cancer 336.02 9.51 125 205852 880 64291875
Appendix cancer 313.71 9.51 73 205904 42 64292713
Incorrect dose administered 312.31 9.51 635 205342 60130 64232625
Thyroid cancer stage II 308.75 9.51 65 205912 0 64292755
Pancreatic carcinoma stage I 289.75 9.51 61 205916 0 64292755
Ovarian cancer 284.96 9.51 160 205817 3159 64289596
Ovarian cancer stage I 270.75 9.51 57 205920 0 64292755
Breast cancer 267.79 9.51 394 205583 28754 64264001
Thyroid cancer stage IV 263.09 9.51 56 205921 3 64292752
Ovarian cancer stage IV 248.79 9.51 60 205917 50 64292705
Hepatic cancer stage III 242.25 9.51 51 205926 0 64292755
Erythema 233.87 9.51 1198 204779 185872 64106883
Synovitis 228.19 9.51 25 205952 99065 64193690
Food allergy 226.04 9.51 193 205784 7658 64285097
Drug abuse 216.61 9.51 76 205901 132298 64160457
Small intestine carcinoma stage IV 213.75 9.51 45 205932 0 64292755
Death 207.74 9.51 816 205161 481889 63810866
Bone cancer 200.46 9.51 98 205879 1437 64291318
Hepatic cancer stage II 199.50 9.51 42 205935 0 64292755
Crystal urine present 196.12 9.51 104 205873 1825 64290930
Urine abnormality 195.85 9.51 173 205804 7189 64285566
Thyroid cancer stage III 194.75 9.51 41 205936 0 64292755
Prostatic disorder 188.15 9.51 97 205880 1602 64291153
Temperature regulation disorder 187.55 9.51 134 205843 4077 64288678
Urinary sediment present 184.51 9.51 105 205872 2129 64290626
Small intestine carcinoma 183.69 9.51 76 205901 732 64292023
Arthropathy 171.33 9.51 86 205891 120881 64171874
Anaphylactic reaction 170.73 9.51 545 205432 68119 64224636
Lymphocyte count decreased 168.68 9.51 390 205587 40309 64252446
Flushing 167.03 9.51 592 205385 78056 64214699
White blood cells urine positive 166.33 9.51 138 205839 5260 64287495
Hepatic cancer stage I 161.50 9.51 34 205943 0 64292755
Lymphocyte percentage decreased 158.33 9.51 126 205851 4523 64288232
Treatment failure 151.06 9.51 93 205884 116723 64176032
Urine leukocyte esterase positive 150.90 9.51 108 205869 3295 64289460
Neutrophil percentage increased 148.24 9.51 119 205858 4326 64288429
Systemic lupus erythematosus 140.59 9.51 37 205940 77575 64215180
Anti-cyclic citrullinated peptide antibody positive 139.62 9.51 4 205973 49558 64243197
Red blood cells urine positive 136.98 9.51 114 205863 4364 64288391
Urine analysis abnormal 136.88 9.51 127 205850 5629 64287126
Off label use 136.06 9.51 1329 204648 631477 63661278
Joint swelling 131.11 9.51 310 205667 215072 64077683
Disease progression 130.07 9.51 836 205141 140844 64151911
Pericarditis 129.20 9.51 22 205955 62494 64230261
Hand deformity 127.74 9.51 23 205954 62748 64230007
Coeliac disease 125.49 9.51 136 205841 7276 64285479
Cervix carcinoma 124.13 9.51 76 205901 1772 64290983
Ovarian cancer stage II 122.85 9.51 27 205950 6 64292749
Drug intolerance 118.91 9.51 265 205712 187727 64105028
Immunodeficiency 118.87 9.51 197 205780 15927 64276828
Gastrooesophageal reflux disease 116.25 9.51 550 205427 82593 64210162
Urticaria 113.69 9.51 833 205144 146484 64146271
Glossodynia 109.54 9.51 35 205942 64661 64228094
Bladder cancer stage I, with cancer in situ 104.50 9.51 22 205955 0 64292755
Cervix carcinoma stage II 99.21 9.51 22 205955 6 64292749
Ovarian cancer stage III 97.91 9.51 32 205945 144 64292611
Rheumatoid factor positive 97.76 9.51 3 205974 34935 64257820
Fall 95.98 9.51 860 205117 415966 63876789
Wound 94.60 9.51 64 205913 76413 64216342
Feeling hot 94.59 9.51 341 205636 45322 64247433
Gallbladder cancer 92.48 9.51 38 205939 359 64292396
Bacterial test 92.41 9.51 54 205923 1153 64291602
Blood urine present 92.21 9.51 190 205787 18150 64274605
Drug interaction 91.00 9.51 730 205247 361353 63931402
Leukaemia 90.79 9.51 96 205881 4992 64287763
Thyroid cancer stage 0 90.25 9.51 19 205958 0 64292755
Breast cancer male 83.20 9.51 30 205947 191 64292564
Intentional overdose 81.81 9.51 100 205877 89844 64202911
Chest discomfort 80.85 9.51 641 205336 115465 64177290
Monocyte percentage increased 80.80 9.51 60 205917 1940 64290815
Tongue carcinoma stage IV 80.75 9.51 17 205960 0 64292755
Small intestine carcinoma stage III 80.75 9.51 17 205960 0 64292755
Gallbladder cancer stage IV 80.75 9.51 17 205960 0 64292755
Drug resistance 80.43 9.51 9 205968 35093 64257662
Duodenal ulcer perforation 79.02 9.51 9 205968 34616 64258139
Overdose 78.89 9.51 254 205723 159312 64133443
Bursitis 78.38 9.51 196 205781 21289 64271466
Condition aggravated 78.18 9.51 786 205191 371640 63921115
Haemoglobin urine present 77.90 9.51 43 205934 820 64291935
Multiple organ dysfunction syndrome 77.14 9.51 128 205849 101285 64191470
Lymphoma 75.54 9.51 149 205828 13792 64278963
Bacterial test positive 74.18 9.51 99 205878 6591 64286164
General physical health deterioration 73.51 9.51 369 205608 204056 64088699
Small intestine carcinoma stage I 71.25 9.51 15 205962 0 64292755
Small intestine carcinoma stage II 71.25 9.51 15 205962 0 64292755
Tongue carcinoma stage III 71.25 9.51 15 205962 0 64292755
Therapeutic product effect incomplete 71.18 9.51 139 205838 103343 64189412
Cervix carcinoma stage I 70.92 9.51 16 205961 6 64292749
Gastric cancer stage 0 70.58 9.51 17 205960 14 64292741
Loss of personal independence in daily activities 69.72 9.51 77 205900 72377 64220378
Cardiac failure 69.48 9.51 205 205772 132168 64160587
Cervix carcinoma stage IV 68.89 9.51 16 205961 9 64292746
Suicide attempt 68.84 9.51 75 205902 70932 64221823
Anaemia 68.79 9.51 826 205151 377854 63914901
Helicobacter infection 68.12 9.51 19 205958 38343 64254412
Pancytopenia 67.49 9.51 233 205744 143076 64149679
Acute kidney injury 65.77 9.51 1024 204953 448216 63844539
Mean cell haemoglobin decreased 63.52 9.51 72 205905 4050 64288705
Chronic kidney disease 63.45 9.51 358 205619 57561 64235194
Folliculitis 63.45 9.51 10 205967 30067 64262688
Adrenal gland cancer 62.90 9.51 19 205958 62 64292693
Lactic acidosis 62.76 9.51 62 205915 61348 64231407
Rash erythematous 62.42 9.51 314 205663 48319 64244436
Toothache 61.32 9.51 157 205820 17302 64275453
COVID-19 60.75 9.51 71 205906 65069 64227686
Urine ketone body present 60.08 9.51 63 205914 3244 64289511
Gamma-glutamyltransferase decreased 59.37 9.51 27 205950 333 64292422
Myocardial infarction 59.21 9.51 300 205677 165521 64127234
C-reactive protein abnormal 58.32 9.51 11 205966 29036 64263719
Therapeutic product effect decreased 57.43 9.51 183 205794 115168 64177587
Injection site pain 55.99 9.51 176 205801 111232 64181523
Cardiac failure congestive 55.78 9.51 221 205756 130359 64162396
Infusion site coldness 53.81 9.51 22 205955 205 64292550
Cervix carcinoma stage III 53.29 9.51 13 205964 12 64292743
Synovial fluid analysis 52.31 9.51 42 205935 1527 64291228
Pancreatic carcinoma stage 0 52.25 9.51 11 205966 0 64292755
Infective pulmonary exacerbation of cystic fibrosis 52.15 9.51 116 205861 11680 64281075
Nitrite urine present 52.13 9.51 36 205941 1036 64291719
Alopecia 51.91 9.51 313 205664 165377 64127378
Renal impairment 51.84 9.51 238 205739 134779 64157976
Colon cancer stage IV 51.61 9.51 21 205956 193 64292562
Muscle injury 51.02 9.51 11 205966 26426 64266329
Tenosynovitis stenosans 50.03 9.51 45 205932 1915 64290840
Swelling 50.02 9.51 303 205674 159915 64132840
Colon cancer stage II 49.30 9.51 17 205960 93 64292662
Nasal cavity cancer 49.20 9.51 19 205958 150 64292605
Contraindicated product administered 48.96 9.51 178 205799 107651 64185104
Intentional product use issue 48.38 9.51 150 205827 95214 64197541
Mastocytosis 47.95 9.51 25 205952 423 64292332
Brain cancer metastatic 47.77 9.51 20 205957 199 64292556
Sense of oppression 46.69 9.51 38 205939 1409 64291346
Maternal exposure during pregnancy 46.42 9.51 154 205823 95730 64197025
Red cell distribution width increased 45.64 9.51 113 205864 12196 64280559
Red blood cell sedimentation rate increased 44.51 9.51 22 205955 31213 64261542
Malignant neoplasm progression 44.50 9.51 197 205780 112674 64180081
Victim of child abuse 44.13 9.51 30 205947 841 64291914
Bronchospasm 44.11 9.51 161 205816 21521 64271234
Product use in unapproved indication 43.85 9.51 357 205620 176261 64116494
Brain stem glioma 43.51 9.51 17 205960 139 64292616
Septic shock 42.80 9.51 182 205795 105255 64187500
Laryngeal cancer stage I 42.75 9.51 9 205968 0 64292755
Gallbladder cancer stage III 42.75 9.51 9 205968 0 64292755
Specific gravity urine increased 42.41 9.51 23 205954 423 64292332
Intentional product misuse 42.40 9.51 106 205871 72189 64220566
Impaired healing 41.77 9.51 81 205896 60392 64232363
Neuroleptic malignant syndrome 41.46 9.51 14 205963 24982 64267773
Infection 40.90 9.51 385 205592 184495 64108260
Sepsis 40.78 9.51 505 205472 229836 64062919
Rhabdomyolysis 40.60 9.51 153 205824 91573 64201182
Mobility decreased 40.10 9.51 140 205837 85700 64207055
Throat tightness 39.78 9.51 163 205814 22997 64269758
Specific gravity urine decreased 39.74 9.51 27 205950 756 64291999
Lung carcinoma cell type unspecified stage 0 39.31 9.51 12 205965 41 64292714
Tonsil cancer 39.23 9.51 29 205948 931 64291824
Blood thyroid stimulating hormone decreased 38.68 9.51 64 205913 5166 64287589
Therapy non-responder 38.35 9.51 97 205880 65802 64226953
Gallbladder cancer stage I 38.00 9.51 8 205969 0 64292755
Anal cancer stage III 38.00 9.51 8 205969 0 64292755
Tongue carcinoma stage II 38.00 9.51 8 205969 0 64292755
Scleritis 37.76 9.51 47 205930 2919 64289836
Thyroxine free increased 37.69 9.51 30 205947 1077 64291678
Weight increased 37.67 9.51 468 205509 212880 64079875
Psoriatic arthropathy 37.40 9.51 50 205927 43231 64249524
Arthritis 36.97 9.51 140 205837 83674 64209081
Pruritus 36.34 9.51 1278 204699 311122 63981633
Encephalopathy 36.27 9.51 84 205893 58735 64234020
Cardio-respiratory arrest 36.26 9.51 176 205801 98217 64194538
Aplastic anaemia 35.96 9.51 112 205865 13808 64278947
Adverse event 35.80 9.51 44 205933 39445 64253310
Discomfort 35.74 9.51 135 205842 80743 64212012
Altered state of consciousness 35.67 9.51 41 205936 37861 64254894
Irritable bowel syndrome 35.63 9.51 40 205937 37329 64255426
Pneumonia 35.11 9.51 1446 204531 558130 63734625
Cerebrovascular accident 35.11 9.51 276 205701 137307 64155448
Accidental exposure to product 34.04 9.51 21 205956 26343 64266412
Urinary casts 34.04 9.51 28 205949 1054 64291701
Respiratory failure 33.81 9.51 340 205637 160843 64131912
Abdominal pain upper 33.81 9.51 764 205213 174266 64118489
Intentional self-injury 33.70 9.51 26 205951 29018 64263737
Band neutrophil percentage increased 33.48 9.51 19 205958 383 64292372
Tongue neoplasm malignant stage unspecified 33.38 9.51 26 205951 904 64291851
Colorectal carcinoma stage 0 33.25 9.51 7 205970 0 64292755
Pain 33.11 9.51 1438 204539 552073 63740682
Computerised tomogram thorax abnormal 33.11 9.51 36 205941 1933 64290822
Drug eruption 33.03 9.51 40 205937 36096 64256659
Lip swelling 32.84 9.51 194 205783 31713 64261042
Hypersensitivity 32.65 9.51 840 205137 195612 64097143
Sopor 32.61 9.51 28 205949 29633 64263122
Blood cholesterol 32.39 9.51 18 205959 348 64292407
Wrong technique in product usage process 32.38 9.51 103 205874 64871 64227884
Arthralgia 32.34 9.51 1122 204855 441138 63851617
Hereditary angioedema 32.19 9.51 50 205927 3826 64288929
Poisoning deliberate 32.00 9.51 3 205974 13455 64279300
Sedation 31.82 9.51 52 205925 41410 64251345
Neuroendocrine carcinoma 31.54 9.51 20 205957 497 64292258
Knee arthroplasty 31.54 9.51 24 205953 26975 64265780
Headache 31.49 9.51 2026 203951 527441 63765314
Infusion site induration 31.45 9.51 24 205953 809 64291946
Bilirubin urine present 31.33 9.51 17 205960 313 64292442
Dyspepsia 31.24 9.51 393 205584 79919 64212836
Hyperkalaemia 31.15 9.51 192 205785 100937 64191818
Laryngeal cancer 31.06 9.51 22 205955 660 64292095
Back pain 30.72 9.51 1030 204947 249141 64043614
Hip arthroplasty 30.48 9.51 15 205962 21336 64271419
Mean cell haemoglobin concentration increased 30.43 9.51 23 205954 764 64291991
Serotonin syndrome 30.40 9.51 49 205928 39233 64253522
Tri-iodothyronine free increased 30.32 9.51 15 205962 226 64292529
Poisoning 30.29 9.51 16 205961 21863 64270892
Ocular hyperaemia 29.88 9.51 147 205830 22417 64270338
COVID-19 pneumonia 29.63 9.51 8 205969 16496 64276259
Hepatic failure 29.62 9.51 85 205892 55309 64237446
Deep vein thrombosis 29.22 9.51 206 205771 104976 64187779
Atrial fibrillation 29.18 9.51 378 205599 170711 64122044
Infusion site pain 29.06 9.51 86 205891 10311 64282444
Hepatic cytolysis 28.90 9.51 5 205972 14044 64278711
Loss of employment 28.86 9.51 33 205944 1874 64290881
Colon cancer stage I 28.81 9.51 10 205967 56 64292699
Therapy interrupted 28.72 9.51 14 205963 20022 64272733
Therapeutic response decreased 28.71 9.51 79 205898 52109 64240646
Depressed level of consciousness 28.67 9.51 148 205829 81288 64211467
Tongue carcinoma stage I 28.50 9.51 6 205971 0 64292755
Cestode infection 28.29 9.51 15 205962 263 64292492
Asthma 28.19 9.51 444 205533 94781 64197974
Lip pruritus 28.14 9.51 21 205956 684 64292071
Cervix carcinoma stage 0 28.00 9.51 14 205963 216 64292539
Acute myeloid leukaemia 27.74 9.51 28 205949 27435 64265320
Parkinsonism 27.70 9.51 6 205971 14367 64278388
Hypoglycaemia 27.51 9.51 171 205806 89721 64203034
Cerebral infarction 27.47 9.51 56 205921 40988 64251767
Stomatitis 27.44 9.51 221 205756 109384 64183371
Cushingoid 27.35 9.51 69 205908 7534 64285221
Band neutrophil count increased 27.25 9.51 20 205957 635 64292120
Pulpitis dental 27.21 9.51 24 205953 995 64291760
Perfume sensitivity 27.14 9.51 20 205957 639 64292116
Culture urine positive 27.02 9.51 48 205929 4103 64288652
Rheumatoid arthritis 26.92 9.51 366 205611 163928 64128827
Cells in urine 26.87 9.51 13 205964 186 64292569
Urethral cancer 26.77 9.51 9 205968 45 64292710
Product use issue 26.69 9.51 333 205644 151382 64141373
Lip and/or oral cavity cancer 26.56 9.51 18 205959 502 64292253
Colon cancer stage III 26.33 9.51 13 205964 195 64292560
Injection site reaction 26.15 9.51 70 205907 46594 64246161
Abortion spontaneous 26.13 9.51 25 205952 25118 64267637
Hepatic function abnormal 26.10 9.51 111 205866 64202 64228553
Tuberculosis 26.04 9.51 5 205972 13033 64279722
Urine leukocyte esterase 26.03 9.51 12 205965 153 64292602
Psychotic disorder 25.95 9.51 44 205933 34534 64258221
Interstitial lung disease 25.90 9.51 194 205783 97538 64195217
Device expulsion 25.71 9.51 18 205959 21118 64271637
Myelosuppression 25.59 9.51 23 205954 23807 64268948
Abdominal discomfort 25.45 9.51 419 205558 181903 64110852
Polymenorrhoea 25.44 9.51 22 205955 888 64291867
Clear cell renal cell carcinoma 25.33 9.51 33 205944 2146 64290609
Red blood cells urine 24.96 9.51 19 205958 638 64292117
Metabolic acidosis 24.95 9.51 129 205848 70829 64221926
Thyroxine free decreased 24.83 9.51 21 205956 822 64291933
Myelodysplastic syndrome 24.71 9.51 31 205946 27548 64265207
Sinusitis 24.67 9.51 323 205654 145605 64147150
Pathogen resistance 24.66 9.51 5 205972 12538 64280217
Chronic obstructive pulmonary disease 24.51 9.51 130 205847 70918 64221837
Nasopharyngeal cancer stage IV 24.36 9.51 6 205971 6 64292749
Thrombocytopenia 24.27 9.51 537 205440 223264 64069491
Lymphocytic infiltration 24.18 9.51 26 205951 1378 64291377
Bone erosion 24.13 9.51 4 205973 11591 64281164
Upper respiratory tract infection 24.11 9.51 346 205631 72439 64220316
Antinuclear antibody 24.00 9.51 16 205961 434 64292321
Eosinophil percentage increased 23.88 9.51 26 205951 1398 64291357
Oropharyngeal oedema 23.83 9.51 13 205964 242 64292513
Gallbladder cancer stage II 23.75 9.51 5 205972 0 64292755
Tongue cancer metastatic 23.75 9.51 5 205972 0 64292755
Oesophageal carcinoma stage 0 23.75 9.51 5 205972 0 64292755
Bladder cancer stage I, without cancer in situ 23.75 9.51 5 205972 0 64292755
Bile duct cancer stage IV 23.75 9.51 5 205972 0 64292755
Anal cancer stage II 23.75 9.51 5 205972 0 64292755
Shock 23.26 9.51 55 205922 38185 64254570
Atelectasis 23.23 9.51 158 205819 27108 64265647
Hepatocellular injury 23.04 9.51 71 205906 45164 64247591
Magnesium deficiency 22.99 9.51 17 205960 546 64292209
Pleuritic pain 22.66 9.51 67 205910 8029 64284726
Bone marrow failure 22.53 9.51 78 205899 47874 64244881
Pharyngitis 22.40 9.51 120 205857 18919 64273836
Blood creatinine decreased 22.32 9.51 61 205916 6989 64285766
Infusion site haemorrhage 22.28 9.51 32 205945 2283 64290472
Urine oxalate increased 22.26 9.51 12 205965 218 64292537
Gastritis 22.25 9.51 221 205756 42397 64250358
Cytomegalovirus infection 22.23 9.51 54 205923 37145 64255610
Hyperhidrosis 22.18 9.51 539 205438 124381 64168374
Osteonecrosis of jaw 22.12 9.51 60 205917 39765 64252990
Localised infection 22.07 9.51 39 205938 30122 64262633
Renal failure 22.04 9.51 428 205549 181260 64111495
Premenstrual syndrome 21.80 9.51 16 205961 508 64292247
Respiratory arrest 21.78 9.51 91 205886 52894 64239861
Cholestasis 21.76 9.51 72 205905 44800 64247955
Liver disorder 21.70 9.51 92 205885 53259 64239496
Oedema peripheral 21.57 9.51 509 205468 209808 64082947
Osteoporosis 21.47 9.51 66 205911 42014 64250741
Rectal cancer stage II 21.41 9.51 5 205972 3 64292752
Lipaemic index score 21.39 9.51 10 205967 132 64292623
Protein urine present 21.26 9.51 70 205907 8886 64283869
Congenital hydrocephalus 21.15 9.51 7 205970 33 64292722
Hepatic enzyme increased 21.10 9.51 290 205687 129653 64163102
Oroantral fistula 21.09 9.51 14 205963 377 64292378
Exposure via body fluid 21.01 9.51 12 205965 245 64292510
Tooth erosion 20.96 9.51 14 205963 381 64292374
Pneumopericardium 20.93 9.51 10 205967 139 64292616
Anaphylactic shock 20.85 9.51 167 205810 30161 64262594
Enthesopathy 20.80 9.51 3 205974 9635 64283120
Blepharospasm 20.66 9.51 38 205939 3337 64289418
Coronary artery disease 20.61 9.51 111 205866 60322 64232433
Computerised tomogram thorax 20.49 9.51 10 205967 146 64292609
Musculoskeletal stiffness 20.35 9.51 274 205703 122932 64169823
Posterior reversible encephalopathy syndrome 20.34 9.51 26 205951 22920 64269835
Fracture 20.26 9.51 18 205959 18737 64274018
Red cell distribution width decreased 20.18 9.51 21 205956 1072 64291683
Injection site erythema 19.99 9.51 138 205839 70662 64222093
Pneumocystis jirovecii pneumonia 19.98 9.51 36 205941 27598 64265157
Nasal sinus cancer 19.91 9.51 8 205969 71 64292684
Synovial cyst 19.90 9.51 62 205915 7645 64285110
Liver injury 19.89 9.51 41 205936 29891 64262864
Reflux gastritis 19.89 9.51 20 205957 980 64291775
Product dose omission issue 19.78 9.51 472 205505 194275 64098480
Kounis syndrome 19.72 9.51 35 205942 2990 64289765
Nasopharyngeal cancer 19.68 9.51 10 205967 160 64292595
Infusion site streaking 19.39 9.51 14 205963 433 64292322
Carcinoid tumour 19.36 9.51 14 205963 434 64292321
Mast cell activation syndrome 19.26 9.51 13 205964 360 64292395
Open angle glaucoma 19.07 9.51 13 205964 366 64292389
Colon cancer 19.06 9.51 86 205891 12653 64280102
Head and neck cancer stage IV 19.00 9.51 4 205973 0 64292755
Laryngeal cancer stage II 19.00 9.51 4 205973 0 64292755
Endocrine neoplasm malignant 19.00 9.51 4 205973 0 64292755
Immune reconstitution inflammatory syndrome 18.99 9.51 8 205969 12462 64280293
Confusional state 18.93 9.51 663 205314 260481 64032274
Myocarditis 18.84 9.51 16 205961 17027 64275728
Bone cancer metastatic 18.83 9.51 10 205967 176 64292579
C-reactive protein increased 18.75 9.51 203 205774 94706 64198049
Eyelid skin dryness 18.73 9.51 8 205969 84 64292671
Second primary malignancy 18.65 9.51 8 205969 12329 64280426
Flatulence 18.64 9.51 185 205792 35481 64257274
Suicidal ideation 18.63 9.51 130 205847 66412 64226343
Paraesthesia 18.62 9.51 562 205415 133960 64158795
Panniculitis 18.62 9.51 3 205974 8876 64283879
Myelocyte percentage increased 18.61 9.51 11 205966 240 64292515
Aspergillus infection 18.57 9.51 15 205962 16364 64276391
Extrapyramidal disorder 18.56 9.51 21 205956 19531 64273224
Vasodilatation 18.50 9.51 34 205943 2984 64289771
Oesophageal polyp 18.49 9.51 7 205970 52 64292703
Tubulointerstitial nephritis 18.49 9.51 165 205812 30744 64262011
Haematochezia 18.43 9.51 130 205847 66243 64226512
Cerebral microhaemorrhage 18.39 9.51 10 205967 185 64292570
Constipation 18.35 9.51 902 205075 228435 64064320
Blood thyroid stimulating hormone increased 18.33 9.51 60 205917 7594 64285161
Infusion related reaction 18.29 9.51 393 205584 164074 64128681
Barotrauma 18.24 9.51 10 205967 188 64292567
Subdural haematoma 18.16 9.51 39 205938 28015 64264740
Injection site haemorrhage 18.12 9.51 31 205946 24247 64268508
Urine bilirubin decreased 18.11 9.51 9 205968 137 64292618
Chills 18.08 9.51 570 205407 136694 64156061
Gastrointestinal disorder 18.07 9.51 191 205786 89518 64203237
Multiple sclerosis relapse 18.06 9.51 206 205771 40929 64251826
Sarcoma 17.81 9.51 16 205961 680 64292075
Dysgeusia 17.77 9.51 229 205748 46818 64245937
Cardiac arrest 17.76 9.51 366 205611 153698 64139057
Laryngeal cancer stage IV 17.67 9.51 5 205972 12 64292743
Haemorrhage 17.63 9.51 165 205812 79186 64213569
Metastases to liver 17.48 9.51 31 205946 23910 64268845
Generalised tonic-clonic seizure 17.30 9.51 67 205910 39790 64252965
Dystonia 17.12 9.51 21 205956 18844 64273911
Femur fracture 17.09 9.51 54 205923 34081 64258674
Peripheral swelling 17.06 9.51 523 205454 208630 64084125
Pericardial effusion 17.03 9.51 66 205911 39188 64253567
Paraesthesia oral 17.00 9.51 85 205892 13046 64279709
Accidental overdose 16.86 9.51 53 205924 33504 64259251
Status epilepticus 16.78 9.51 27 205950 21636 64271119
Tryptase increased 16.76 9.51 13 205964 449 64292306
Device malfunction 16.67 9.51 19 205958 17614 64275141
Tooth deposit 16.65 9.51 10 205967 225 64292530
Osteoarthritis 16.64 9.51 126 205851 63210 64229545
Rectal cancer stage III 16.63 9.51 5 205972 16 64292739
Bundle branch block right 16.61 9.51 6 205971 10263 64282492
Blood creatine phosphokinase increased 16.60 9.51 114 205863 58444 64234311
Graft versus host disease 16.49 9.51 12 205965 13801 64278954
Epidural lipomatosis 16.46 9.51 17 205960 860 64291895
Gingival atrophy 16.43 9.51 7 205970 73 64292682
Prostatomegaly 16.42 9.51 32 205945 2935 64289820
Cytomegalovirus viraemia 16.40 9.51 7 205970 10821 64281934
Acute hepatic failure 16.33 9.51 37 205940 26075 64266680
Transaminases increased 16.29 9.51 80 205897 44514 64248241
Aggression 16.28 9.51 84 205893 46148 64246607
Dystrophic calcification 16.20 9.51 8 205969 120 64292635
Pulmonary embolism 16.19 9.51 350 205627 146006 64146749
Drug-induced liver injury 15.98 9.51 88 205889 47555 64245200
Oesophagitis 15.91 9.51 121 205856 21509 64271246
Acute myocardial infarction 15.91 9.51 144 205833 69574 64223181
Paraneoplastic rash 15.86 9.51 7 205970 80 64292675
Gastrointestinal stromal tumour 15.83 9.51 21 205956 1390 64291365
Diabetic ketoacidosis 15.81 9.51 46 205931 29799 64262956
Endometrial cancer stage II 15.77 9.51 4 205973 5 64292750
Red blood cell count increased 15.76 9.51 35 205942 3520 64289235
Haematoma 15.74 9.51 85 205892 46165 64246590
Oedema 15.71 9.51 203 205774 91732 64201023
Angioedema 15.63 9.51 281 205696 61540 64231215
Pharyngeal swelling 15.55 9.51 46 205931 5513 64287242
Drug monitoring procedure not performed 15.55 9.51 16 205961 806 64291949
Ureteric cancer 15.51 9.51 10 205967 256 64292499
Fluid retention 15.45 9.51 272 205705 59334 64233421
Swelling face 15.34 9.51 270 205707 58896 64233859
Haemodynamic instability 15.30 9.51 15 205962 14897 64277858
Thyroid stimulating immunoglobulin increased 15.27 9.51 7 205970 88 64292667
Pregnancy 15.25 9.51 27 205950 20838 64271917
Miosis 15.23 9.51 12 205965 13254 64279501
Acute graft versus host disease 15.22 9.51 5 205972 9079 64283676
Sedation complication 15.20 9.51 7 205970 10347 64282408
Ischaemic stroke 15.20 9.51 45 205932 28990 64263765
Gastrointestinal haemorrhage 15.05 9.51 315 205662 131997 64160758
Arrhythmia 15.04 9.51 103 205874 52841 64239914
Laryngeal cancer stage III 15.04 9.51 5 205972 24 64292731
Neutropenia 15.01 9.51 619 205358 239005 64053750
Systemic mastocytosis 14.97 9.51 10 205967 272 64292483
Disease recurrence 14.97 9.51 51 205926 31459 64261296
Oxygen saturation decreased 14.90 9.51 448 205529 106728 64186027
Myelocyte count increased 14.88 9.51 15 205962 737 64292018
Pneumonia aspiration 14.84 9.51 269 205708 59002 64233753
Long QT syndrome 14.83 9.51 43 205934 5096 64287659
Haematopoietic stem cell mobilisation 14.81 9.51 9 205968 207 64292548
Pleural effusion 14.78 9.51 300 205677 126259 64166496
Cerebral haemorrhage 14.71 9.51 99 205878 50991 64241764
Feeling jittery 14.59 9.51 70 205907 10565 64282190
Incorrect route of product administration 14.58 9.51 33 205944 23265 64269490
Haemophagocytic lymphohistiocytosis 14.55 9.51 21 205956 17588 64275167
Excessive eye blinking 14.52 9.51 19 205958 1241 64291514
Infusion site bruising 14.49 9.51 21 205956 1511 64291244
Lichen sclerosus 14.39 9.51 16 205961 881 64291874
Nasopharyngitis 14.39 9.51 497 205480 195576 64097179
Head and neck cancer 14.36 9.51 9 205968 219 64292536
Venoocclusive liver disease 14.35 9.51 7 205970 10008 64282747
Abnormal behaviour 14.28 9.51 57 205920 33565 64259190
Subarachnoid haemorrhage 14.26 9.51 23 205954 18415 64274340
Salivary gland cancer stage I 14.25 9.51 3 205974 0 64292755
Gallbladder cancer stage 0 14.25 9.51 3 205974 0 64292755
Oesophageal adenocarcinoma stage IV 14.25 9.51 3 205974 0 64292755
Bile duct cancer stage III 14.25 9.51 3 205974 0 64292755
Follicular lymphoma stage III 14.25 9.51 3 205974 0 64292755
Head and neck cancer stage II 14.25 9.51 3 205974 0 64292755
Epiglottic cancer 14.25 9.51 3 205974 0 64292755
Device issue 14.24 9.51 32 205945 22616 64270139
Extravasation blood 14.23 9.51 11 205966 378 64292377
Hot flush 14.22 9.51 217 205760 46018 64246737
Spinal cord neoplasm 14.20 9.51 10 205967 297 64292458
Anti-thyroid antibody positive 14.18 9.51 12 205965 470 64292285
Blood glucose increased 14.13 9.51 224 205753 97849 64194906
Respiratory depth decreased 14.12 9.51 5 205972 30 64292725
Eosinophilia 14.08 9.51 68 205909 38008 64254747
Antinuclear antibody positive 14.08 9.51 48 205929 6202 64286553
Urethral pain 14.04 9.51 11 205966 386 64292369
Labelled drug-drug interaction medication error 14.01 9.51 31 205946 22031 64270724
Sneezing 13.97 9.51 90 205887 15161 64277594
Neurotoxicity 13.96 9.51 43 205934 27361 64265394
Unevaluable event 13.96 9.51 99 205878 50390 64242365
Ill-defined disorder 13.89 9.51 83 205894 43969 64248786
Crepitations 13.83 9.51 56 205921 7859 64284896
Device difficult to use 13.81 9.51 7 205970 9791 64282964
Paternal exposure timing unspecified 13.80 9.51 6 205971 66 64292689
Sleep disorder 13.77 9.51 123 205854 59586 64233169
Hyperreflexia 13.74 9.51 3 205974 7145 64285610
End stage renal disease 13.69 9.51 68 205909 10407 64282348
Monocyte count decreased 13.66 9.51 29 205948 2828 64289927
Optic discs blurred 13.64 9.51 6 205971 68 64292687
Disseminated intravascular coagulation 13.64 9.51 55 205922 32293 64260462
Polyarthritis 13.60 9.51 7 205970 9708 64283047
Full blood count abnormal 13.58 9.51 49 205928 29708 64263047
Cardiotoxicity 13.52 9.51 8 205969 10266 64282489
Haemolytic anaemia 13.41 9.51 19 205958 16034 64276721
Muscle rigidity 13.33 9.51 22 205955 17451 64275304
Haematocrit decreased 13.32 9.51 247 205730 54408 64238347
Brain neoplasm 13.30 9.51 40 205937 4838 64287917
Joint stiffness 13.26 9.51 51 205926 30353 64262402
Blood pressure fluctuation 13.25 9.51 104 205873 51767 64240988
Migraine 13.17 9.51 277 205700 62400 64230355
Agranulocytosis 13.16 9.51 70 205907 38159 64254596
Creatinine renal clearance decreased 13.14 9.51 16 205961 14405 64278350
Throat irritation 13.12 9.51 161 205816 32550 64260205
Drug ineffective for unapproved indication 13.09 9.51 53 205924 31080 64261675
Ankylosing spondylitis 13.00 9.51 5 205972 8229 64284526
Sudden death 12.96 9.51 28 205949 20068 64272687
Aphasia 12.94 9.51 77 205900 40829 64251926
Conjunctivitis 12.88 9.51 110 205867 20244 64272511
Visual acuity reduced 12.85 9.51 44 205933 27097 64265658
Rectal cancer metastatic 12.85 9.51 11 205966 438 64292317
Menstruation delayed 12.62 9.51 17 205960 1142 64291613
Unintentional medical device removal 12.60 9.51 3 205974 6731 64286024
Cutaneous lupus erythematosus 12.57 9.51 27 205950 2655 64290100
Brain injury 12.54 9.51 64 205913 9901 64282854
Bezoar 12.49 9.51 24 205953 2179 64290576
Adrenal insufficiency 12.39 9.51 34 205943 22453 64270302
Post-traumatic neck syndrome 12.39 9.51 22 205955 1880 64290875
Hyperaemia 12.38 9.51 27 205950 2682 64290073
Anorectal discomfort 12.34 9.51 28 205949 2857 64289898
Blister 12.32 9.51 183 205794 80784 64211971
Heart rate increased 12.28 9.51 407 205570 98268 64194487
Rectal cancer stage IV 12.18 9.51 3 205974 3 64292752
Chronic lymphocytic leukaemia stage 1 12.18 9.51 3 205974 3 64292752
Drug level increased 12.11 9.51 62 205915 34134 64258621
HIV associated nephropathy 12.09 9.51 9 205968 292 64292463
Haematotoxicity 12.08 9.51 14 205963 12882 64279873
Cardiomyopathy 12.08 9.51 41 205936 25315 64267440
Delusion of replacement 12.04 9.51 7 205970 148 64292607
Feeling cold 11.98 9.51 122 205855 23556 64269199
Syncope 11.93 9.51 398 205579 157237 64135518
Asthenia 11.92 9.51 1191 204786 426853 63865902
Staphylococcal infection 11.86 9.51 104 205873 50574 64242181
Crystalluria 11.84 9.51 14 205963 824 64291931
Carcinoid syndrome 11.83 9.51 7 205970 153 64292602
Orthostatic hypotension 11.80 9.51 94 205883 46644 64246111
Chronic spontaneous urticaria 11.77 9.51 11 205966 492 64292263
Acanthosis 11.73 9.51 10 205967 396 64292359
Hypoaesthesia 11.72 9.51 550 205427 138558 64154197
Total lung capacity abnormal 11.71 9.51 7 205970 156 64292599
Injection site induration 11.69 9.51 7 205970 8925 64283830
Device dislocation 11.69 9.51 32 205945 21146 64271609
Mitral valve incompetence 11.69 9.51 42 205935 25496 64267259
Tachycardia 11.68 9.51 587 205390 148992 64143763
Hypercalcaemia 11.68 9.51 56 205921 31360 64261395
Abortion induced 11.65 9.51 3 205974 6385 64286370
Leukocyturia 11.62 9.51 19 205958 1519 64291236
Food intolerance 11.61 9.51 27 205950 2799 64289956
Ear discomfort 11.54 9.51 50 205927 7230 64285525
Pulmonary thrombosis 11.47 9.51 10 205967 10508 64282247
Glycosylated haemoglobin increased 11.46 9.51 21 205956 15998 64276757
Endocrine ophthalmopathy 11.45 9.51 10 205967 409 64292346
Palmar erythema 11.42 9.51 20 205957 1690 64291065
Urobilinogen urine increased 11.41 9.51 12 205965 620 64292135
Intestinal metaplasia 11.29 9.51 4 205973 24 64292731
Diabetes mellitus 11.27 9.51 147 205830 66327 64226428
Progressive multifocal leukoencephalopathy 11.27 9.51 26 205951 18206 64274549
Diarrhoea 11.26 9.51 2085 203892 720619 63572136
Inflammation 11.22 9.51 144 205833 65156 64227599
Airway remodelling 11.22 9.51 7 205970 169 64292586
Respiratory acidosis 11.21 9.51 9 205968 9846 64282909
Pituitary apoplexy 11.18 9.51 7 205970 170 64292585
Bronchopulmonary aspergillosis 11.17 9.51 28 205949 19057 64273698
Defaecation urgency 11.15 9.51 33 205944 3956 64288799
pH urine increased 11.15 9.51 10 205967 424 64292331
Tonsillar haemorrhage 11.09 9.51 8 205969 247 64292508
Temperature intolerance 11.09 9.51 54 205923 8201 64284554
Foetal malpresentation 11.04 9.51 5 205972 61 64292694
Bacillus bacteraemia 11.03 9.51 6 205971 111 64292644
Bronchiolitis 11.03 9.51 31 205946 3610 64289145
Renal cell carcinoma stage III 11.02 9.51 4 205973 26 64292729
Hypoaesthesia oral 11.02 9.51 69 205908 11511 64281244
Haematocrit 10.97 9.51 3 205974 6 64292749
C-kit gene mutation 10.97 9.51 3 205974 6 64292749
Skin necrosis 10.97 9.51 18 205959 14311 64278444
Delusion 10.88 9.51 26 205951 17988 64274767
Pregnancy on contraceptive 10.82 9.51 13 205964 778 64291977
Mean cell haemoglobin concentration decreased 10.80 9.51 31 205946 3653 64289102
Cystitis haemorrhagic 10.75 9.51 6 205971 7950 64284805
Drug use disorder 10.74 9.51 3 205974 6051 64286704
Photophobia 10.70 9.51 93 205884 17200 64275555
International normalised ratio increased 10.69 9.51 183 205794 78984 64213771
Eosinophil percentage decreased 10.68 9.51 8 205969 262 64292493
Osteonecrosis 10.68 9.51 50 205927 28179 64264576
Occupational asthma 10.66 9.51 3 205974 7 64292748
Glomerulonephritis chronic 10.63 9.51 8 205969 264 64292491
Hallucination, auditory 10.59 9.51 24 205953 16915 64275840
Macroglossia 10.59 9.51 15 205962 1057 64291698
Thyroid stimulating immunoglobulin 10.56 9.51 5 205972 68 64292687
Nail dystrophy 10.54 9.51 13 205964 800 64291955
Lactobacillus test positive 10.54 9.51 4 205973 30 64292725
Product administration error 10.44 9.51 49 205928 27594 64265161
Mean cell haemoglobin increased 10.43 9.51 28 205949 3174 64289581
Hepatocellular carcinoma 10.43 9.51 7 205970 8396 64284359
Bundle branch block left 10.40 9.51 10 205967 10024 64282731
Basal cell carcinoma 10.32 9.51 57 205920 30781 64261974
Periodontitis 10.32 9.51 33 205944 4126 64288629
Head injury 10.29 9.51 62 205915 32780 64259975
White blood cells urine 10.29 9.51 9 205968 369 64292386
Akathisia 10.25 9.51 13 205964 11497 64281258
Bronchoscopy 10.25 9.51 5 205972 73 64292682
High frequency ablation 10.23 9.51 8 205969 280 64292475
Granulocyte percentage 10.19 9.51 5 205972 74 64292681
Agitation 10.16 9.51 210 205767 88157 64204598
Bronchitis 10.10 9.51 267 205710 108476 64184279
Fumbling 10.07 9.51 6 205971 133 64292622
Cellulitis 10.06 9.51 225 205752 93432 64199323
Hepatitis 10.03 9.51 95 205882 45487 64247268
Product quality issue 10.01 9.51 55 205922 29744 64263011
Product storage error 9.94 9.51 17 205960 13301 64279454
Tenosynovitis 9.89 9.51 14 205963 11819 64280936
Blood aluminium increased 9.88 9.51 3 205974 10 64292745
Transplant rejection 9.82 9.51 26 205951 17375 64275380
Breast cancer in situ 9.82 9.51 13 205964 859 64291896
Therapy partial responder 9.74 9.51 11 205966 10237 64282518
Joint injury 9.69 9.51 39 205938 22908 64269847
Rash macular 9.68 9.51 117 205860 23568 64269187
Hypotension 9.66 9.51 1067 204910 379907 63912848
Pneumonia bacterial 9.65 9.51 21 205956 15014 64277741
Cystic fibrosis respiratory infection suppression 9.64 9.51 9 205968 402 64292353
Premature labour 9.63 9.51 49 205928 7571 64285184
Pulmonary oedema 9.63 9.51 185 205792 78489 64214266
Rectal cancer 9.61 9.51 25 205952 2781 64289974
Bronchopulmonary aspergillosis allergic 9.60 9.51 18 205959 1604 64291151
Injection site pruritus 9.59 9.51 76 205901 37750 64255005
Injection site urticaria 9.57 9.51 13 205964 11168 64281587
Blood creatinine abnormal 9.57 9.51 32 205945 4095 64288660
Pulmonary arterial hypertension 9.56 9.51 45 205932 25322 64267433
Tumour lysis syndrome 9.56 9.51 31 205946 19409 64273346
Drug reaction with eosinophilia and systemic symptoms 9.53 9.51 119 205858 54098 64238657

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A02BA02 ALIMENTARY TRACT AND METABOLISM
DRUGS FOR ACID RELATED DISORDERS
DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
H2-receptor antagonists
FDA MoA N0000000151 Histamine H2 Receptor Antagonists
MeSH PA D000897 Anti-Ulcer Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006635 Histamine H2 Antagonists
MeSH PA D018377 Neurotransmitter Agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:37961 H2 receptor antagonists
CHEBI has role CHEBI:49201 anti-ulcer drugs
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
FDA EPC N0000175784 Histamine-2 Receptor Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Heartburn indication 16331000
Erosive esophagitis indication 40719004
Duodenal ulcer disease indication 51868009 DOID:1724
Zollinger-Ellison syndrome indication 53132006 DOID:0050782
Indigestion indication 162031009
Gastroesophageal reflux disease indication 235595009 DOID:8534
Gastric ulcer indication 397825006 DOID:10808
Duodenal Ulcer due to H. Pylori indication
Gastric Hypersecretory Conditions indication
Maintenance of Healing Gastric Ulcer indication
Upper gastrointestinal hemorrhage off-label use 37372002
Prevention of NSAID-Induced Gastric Ulcer off-label use
Fatty Stool as Cystic Fibrosis Intestinal Manifestation off-label use
Prevention of Stress Ulcer off-label use
NSAID-Induced Gastric Ulcer off-label use
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Malignant tumor of stomach contraindication 363349007 DOID:10534
Porphyria contraindication 418470004




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.39 Basic
pKa2 6.17 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H2 receptor GPCR ANTAGONIST Kd 6.86 WOMBAT-PK CHEMBL
Acetylcholinesterase Enzyme IC50 6.19 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.08 CHEMBL
Histamine H2 receptor GPCR Kd 7.19 CHEMBL
Histamine H2 receptor GPCR ANTAGONIST Ki 6.20 IUPHAR

External reference:

IDSource
D00422 KEGG_DRUG
66357-59-3 SECONDARY_CAS_RN
4018896 VANDF
4019927 VANDF
CHEBI:8776 CHEBI
CHEMBL1790041 ChEMBL_ID
CHEMBL2110372 ChEMBL_ID
1234 IUPHAR_LIGAND_ID
4660 INN_ID
DB00863 DRUGBANK_ID
884KT10YB7 UNII
3001055 PUBCHEM_CID
152523 RXNORM
1431 MMSL
5413 MMSL
911 MMSL
d00021 MMSL
003416 NDDF
004444 NDDF
24202000 SNOMEDCT_US
372755005 SNOMEDCT_US
48174005 SNOMEDCT_US
D011899 MESH_DESCRIPTOR_UI
C0034665 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 0121-0727 SYRUP 15 mg ORAL ANDA 23 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 0121-4727 SYRUP 15 mg ORAL ANDA 23 sections
Wal-Zan HUMAN OTC DRUG LABEL 1 0363-0010 TABLET, COATED 150 mg ORAL ANDA 13 sections
Wal-Zan 75 HUMAN OTC DRUG LABEL 1 0363-0131 TABLET 75 mg ORAL ANDA 14 sections
Ranitidine HUMAN OTC DRUG LABEL 1 0363-0352 TABLET, FILM COATED 75 mg ORAL ANDA 14 sections
Wal-Zan HUMAN OTC DRUG LABEL 1 0363-0362 TABLET 150 mg ORAL ANDA 14 sections
Ranitidine HUMAN OTC DRUG LABEL 1 0440-2300 TABLET, FILM COATED 150 mg ORAL ANDA 14 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 0440-8300 TABLET 150 mg ORAL ANDA 10 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 0440-8305 TABLET 150 mg ORAL ANDA 10 sections
Ranitidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2855 CAPSULE 150 mg ORAL ANDA 24 sections
Ranitidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2865 CAPSULE 300 mg ORAL ANDA 24 sections
ranitidine 75 HUMAN OTC DRUG LABEL 1 0904-6715 TABLET, COATED 75 mg ORAL ANDA 15 sections
Ranitidine HUMAN OTC DRUG LABEL 1 0904-6921 TABLET 75 mg ORAL ANDA 14 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 10544-056 TABLET 150 mg ORAL ANDA 11 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 10544-438 TABLET, FILM COATED 150 mg ORAL ANDA 24 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 10544-516 TABLET 150 mg ORAL ANDA 11 sections
Ranitidine HUMAN OTC DRUG LABEL 1 11673-849 TABLET, COATED 150 mg ORAL ANDA 14 sections
Acid Reducer HUMAN OTC DRUG LABEL 1 15127-340 TABLET 150 mg ORAL ANDA 14 sections
Ranitidine Hydrochloride HUMAN OTC DRUG LABEL 1 15127-711 TABLET, FILM COATED 75 mg ORAL ANDA 14 sections
RANITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-200 TABLET 150 mg ORAL ANDA 10 sections
RANITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 16590-381 TABLET 300 mg ORAL ANDA 10 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 17856-0664 SOLUTION 15 mg ORAL ANDA 10 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 17856-0727 SOLUTION 15 mg ORAL ANDA 24 sections
Acid Reducer HUMAN OTC DRUG LABEL 1 21130-003 TABLET, FILM COATED 75 mg ORAL ANDA 14 sections
Acid Reducer 150 HUMAN OTC DRUG LABEL 1 21130-404 TABLET, COATED 150 mg ORAL ANDA 14 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 21695-109 TABLET 150 mg ORAL ANDA 10 sections
Ranitidine HUMAN PRESCRIPTION DRUG LABEL 1 21695-110 TABLET 300 mg ORAL ANDA 10 sections
Ranitidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-337 CAPSULE 150 mg ORAL ANDA 24 sections
Ranitidine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-338 CAPSULE 300 mg ORAL ANDA 24 sections
Ranitidine Human Prescription Drug Label 1 27241-109 CAPSULE 150 mg ORAL ANDA 19 sections