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

Stem definitionDrug idCAS RN
serotonin receptor antagonists (5-HT3) 1992 99614-02-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • GR-38032F
  • GR38032F
  • ondansetron
  • ondansetron hydrochloride
  • ondansetron hydrochloride dihydrate
  • ondansetron HCl
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
  • Molecular weight: 293.37
  • Formula: C18H19N3O
  • CLOGP: 2.72
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 39.82
  • ALOGS: -3.07
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
16 mg O
16 mg P
16 mg R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 5.70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.17 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.27 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.40 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 4, 1991 FDA NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 891.08 9.89 1091 191388 818242 49594403
Febrile neutropenia 776.35 9.89 1358 191121 96309 50316336
Nausea 560.08 9.89 4577 187902 700821 49711824
Vomiting 520.01 9.89 3257 189222 457501 49955144
Contraindicated product administered 432.08 9.89 36 192443 148922 50263723
Synovitis 431.08 9.89 8 192471 123857 50288788
Joint swelling 402.27 9.89 216 192263 245070 50167575
Constipation 395.51 9.89 1574 190905 184134 50228511
Systemic lupus erythematosus 369.36 9.89 49 192430 140573 50272072
Rheumatoid arthritis 364.65 9.89 157 192322 202393 50210252
Diarrhoea 349.64 9.89 3591 188888 584885 49827760
Hand deformity 346.50 9.89 7 192472 100192 50312453
Arthropathy 331.08 9.89 95 192384 157811 50254834
Therapeutic product effect decreased 318.16 9.89 65 192414 135985 50276660
Drug intolerance 316.04 9.89 224 192255 218880 50193765
Treatment failure 301.36 9.89 76 192403 137561 50275084
Glossodynia 258.47 9.89 61 192418 115508 50297137
Dehydration 243.48 9.89 1186 191293 151263 50261382
Neutropenia 236.93 9.89 1152 191327 146813 50265832
Abdominal pain 227.70 9.89 1608 190871 234620 50178025
Disease progression 227.05 9.89 841 191638 95025 50317620
Wound 221.02 9.89 64 192415 105730 50306915
Pericarditis 220.07 9.89 22 192457 78667 50333978
Arthralgia 213.31 9.89 902 191577 437800 49974845
Swelling 193.68 9.89 290 192189 200582 50212063
Torsade de pointes 188.62 9.89 229 192250 11606 50401039
Neuropathy peripheral 181.20 9.89 789 191690 95968 50316677
Emotional distress 169.75 9.89 352 192127 28311 50384334
Death 167.34 9.89 1932 190547 323447 50089198
White blood cell count decreased 166.54 9.89 880 191599 115842 50296803
Thrombocytopenia 165.01 9.89 937 191542 126736 50285909
Decreased appetite 160.99 9.89 1310 191169 199613 50213032
Drug abuse 154.33 9.89 22 192457 59824 50352821
Mucosal inflammation 153.83 9.89 416 192063 39726 50372919
Hepatic enzyme increased 151.01 9.89 180 192299 137200 50275445
Duodenal ulcer perforation 150.82 9.89 5 192474 45606 50367039
Toxicity to various agents 150.43 9.89 369 192110 212130 50200515
Plasma cell myeloma 149.71 9.89 353 192126 30969 50381676
Impaired healing 146.13 9.89 42 192437 69744 50342901
Musculoskeletal stiffness 144.80 9.89 165 192314 128316 50284329
Hypoxia 143.00 9.89 474 192005 50649 50361996
Serotonin syndrome 139.95 9.89 298 192181 24415 50388230
Helicobacter infection 138.68 9.89 14 192465 49688 50362957
Electrocardiogram QT prolonged 135.39 9.89 470 192009 51416 50361229
Drug hypersensitivity 133.16 9.89 498 191981 250512 50162133
Febrile bone marrow aplasia 127.40 9.89 138 192341 6173 50406472
Muscle injury 126.65 9.89 3 192476 37108 50375537
Encephalopathy 124.82 9.89 345 192134 33366 50379279
Discomfort 119.08 9.89 142 192337 108238 50304407
Left-to-right cardiac shunt 117.52 9.89 36 192443 99 50412546
Completed suicide 111.64 9.89 207 192272 131682 50280963
Erythema 110.43 9.89 942 191537 145472 50267173
Neutropenic sepsis 108.65 9.89 194 192285 13953 50398692
Mobility decreased 108.34 9.89 87 192392 79861 50332784
Abdominal discomfort 105.15 9.89 488 191991 231153 50181492
Heart disease congenital 103.09 9.89 62 192417 1164 50411481
Therapeutic product effect incomplete 102.57 9.89 118 192361 91397 50321248
Pyrexia 102.09 9.89 2020 190459 378183 50034462
Sleep disorder due to general medical condition, insomnia type 102.05 9.89 4 192475 31443 50381202
Fatigue 101.63 9.89 3458 189021 704143 49708502
Small intestinal obstruction 95.91 9.89 198 192281 15870 50396775
Cytokine release syndrome 95.87 9.89 140 192339 8494 50404151
Injection site pain 95.06 9.89 173 192306 110851 50301794
Colitis 94.48 9.89 342 192137 38187 50374458
Ventricular tachycardia 93.32 9.89 194 192285 15627 50397018
Flushing 92.61 9.89 501 191978 66514 50346131
Neutrophil count decreased 91.24 9.89 382 192097 45644 50367001
Folliculitis 91.08 9.89 19 192460 39206 50373439
Condition aggravated 90.01 9.89 711 191768 296347 50116298
Intentional overdose 89.83 9.89 64 192415 62440 50350205
Injury 87.00 9.89 393 192086 48532 50364113
Blood cholesterol increased 84.10 9.89 53 192426 55162 50357483
Full blood count decreased 83.02 9.89 229 192250 22117 50390528
Hereditary angioedema 83.00 9.89 103 192376 5339 50407306
Weight increased 80.94 9.89 444 192035 201447 50211198
Knee arthroplasty 77.99 9.89 20 192459 35826 50376819
Sepsis 76.65 9.89 808 191671 132117 50280528
Overdose 76.26 9.89 166 192313 99561 50313084
C-reactive protein abnormal 74.62 9.89 9 192470 27800 50384845
Hospice care 72.08 9.89 99 192380 5673 50406972
Intentional self-injury 71.57 9.89 4 192475 23108 50389537
Injection site erythema 71.33 9.89 109 192370 74827 50337818
Lower respiratory tract infection 70.71 9.89 161 192318 95040 50317605
Platelet count decreased 70.67 9.89 638 191841 100088 50312557
Laryngospasm 69.19 9.89 67 192412 2621 50410024
Long QT syndrome 69.05 9.89 70 192409 2897 50409748
Red blood cell sedimentation rate increased 68.81 9.89 14 192465 29402 50383243
Oculogyric crisis 68.37 9.89 51 192428 1386 50411259
Irritable bowel syndrome 67.18 9.89 58 192421 51383 50361262
Anaemia 66.50 9.89 1338 191141 251118 50161527
Type 2 diabetes mellitus 66.09 9.89 24 192455 34351 50378294
Injection site swelling 65.14 9.89 39 192440 41734 50370911
Myocardial infarction 64.96 9.89 152 192327 88875 50323770
Abortion spontaneous 63.75 9.89 40 192439 41732 50370913
Malignant neoplasm progression 62.67 9.89 459 192020 67665 50344980
Hip arthroplasty 62.43 9.89 19 192460 30410 50382235
Osteoarthritis 62.26 9.89 103 192376 68503 50344142
Therapeutic response decreased 61.99 9.89 53 192426 47178 50365467
Anhedonia 61.18 9.89 121 192358 9403 50403242
Loss of personal independence in daily activities 60.98 9.89 108 192371 69942 50342703
Device expulsion 59.13 9.89 18 192461 28804 50383841
Carbohydrate antigen 125 increased 58.87 9.89 59 192420 2408 50410237
Dystonia 58.71 9.89 136 192343 11790 50400855
Chills 58.69 9.89 594 191885 96093 50316552
Neoplasm progression 58.56 9.89 243 192236 28914 50383731
Aplastic anaemia 58.34 9.89 105 192374 7598 50405047
Asthenia 58.25 9.89 1607 190872 317435 50095210
Tachycardia 58.23 9.89 608 191871 99155 50313490
Inflammation 57.89 9.89 79 192400 56833 50355812
Pancytopenia 57.79 9.89 530 191949 83500 50329145
Congenital anomaly 57.25 9.89 47 192432 1474 50411171
Injection site reaction 56.60 9.89 64 192415 49968 50362677
Intestinal obstruction 55.46 9.89 223 192256 26160 50386485
Alopecia 53.98 9.89 634 191845 244413 50168232
Osteoporosis 53.44 9.89 55 192424 44824 50367821
Suicide attempt 53.43 9.89 71 192408 51661 50360984
Dysgeusia 53.11 9.89 290 192189 38626 50374019
Ventricular fibrillation 51.53 9.89 120 192359 10439 50402206
Retching 50.97 9.89 135 192344 12727 50399918
Palmar-plantar erythrodysaesthesia syndrome 50.62 9.89 180 192299 19918 50392727
Nasopharyngitis 50.23 9.89 480 191999 192447 50220198
Pleural effusion 50.19 9.89 502 191977 80952 50331693
Atelectasis 49.82 9.89 168 192311 18102 50394543
Clostridium difficile infection 49.52 9.89 210 192269 25229 50387416
Anxiety 49.30 9.89 949 191530 176657 50235988
Fall 48.79 9.89 939 191540 333993 50078652
Desmoplastic small round cell tumour 48.77 9.89 15 192464 42 50412603
Opisthotonus 48.14 9.89 24 192455 305 50412340
Hypomagnesaemia 48.09 9.89 195 192284 22961 50389684
Arthritis 47.23 9.89 170 192309 86551 50326094
Hair colour changes 47.18 9.89 55 192424 2669 50409976
Hypokalaemia 47.05 9.89 527 191952 87465 50325180
Femur fracture 46.82 9.89 44 192435 37420 50375225
Clonus 45.34 9.89 67 192412 4108 50408537
Psoriatic arthropathy 45.15 9.89 68 192411 46964 50365681
Dilatation intrahepatic duct acquired 45.08 9.89 29 192450 616 50412029
Pain 45.05 9.89 1774 190705 577129 49835516
Ascites 43.52 9.89 259 192220 35602 50377043
Calcium ionised decreased 43.48 9.89 21 192458 248 50412397
Osteonecrosis of jaw 43.29 9.89 36 192443 32490 50380155
Accidental exposure to product 42.82 9.89 17 192462 23040 50389605
Hypotension 42.34 9.89 1184 191295 234285 50178360
Dyspnoea 41.75 9.89 2511 189968 545097 49867548
Sopor 41.53 9.89 12 192467 19867 50392778
Feeling hot 41.26 9.89 273 192206 38929 50373716
Coronary artery disease 40.69 9.89 32 192447 29694 50382951
Dermatitis diaper 40.51 9.89 18 192461 173 50412472
Blood pressure systolic increased 40.47 9.89 45 192434 35404 50377241
Impaired gastric emptying 40.29 9.89 97 192382 8621 50404024
Anaphylactic reaction 40.27 9.89 347 192132 53708 50358937
Oxygen saturation decreased 40.20 9.89 441 192038 72807 50339838
Injection site pruritus 40.19 9.89 57 192422 40354 50372291
Failure to thrive 39.90 9.89 80 192399 6278 50406367
Otitis media chronic 39.20 9.89 16 192463 122 50412523
Segmental diverticular colitis 39.09 9.89 16 192463 123 50412522
Drug resistance 38.70 9.89 12 192467 18977 50393668
Sedation 38.19 9.89 36 192443 30574 50382071
Blister 38.06 9.89 181 192298 85237 50327408
Back pain 37.78 9.89 1100 191379 218930 50193715
Ill-defined disorder 37.74 9.89 96 192383 54558 50358087
Atrial septal defect 37.68 9.89 78 192401 6263 50406382
Product use issue 37.58 9.89 375 192104 149100 50263545
Lactic acidosis 37.36 9.89 43 192436 33312 50379333
Rheumatoid nodule 37.10 9.89 3 192476 12732 50399913
Psoriasis 37.08 9.89 136 192343 68864 50343781
C-reactive protein increased 37.07 9.89 129 192350 66345 50346300
Respiratory syncytial virus infection 36.68 9.89 68 192411 5034 50407611
Electrocardiogram QRS complex 36.61 9.89 8 192471 0 50412645
Asthma 36.56 9.89 195 192284 89142 50323503
Intentional product misuse 36.36 9.89 77 192402 46657 50365988
Diabetes mellitus 36.33 9.89 83 192396 48950 50363695
Product use in unapproved indication 36.00 9.89 630 191849 115189 50297456
Pulmonary embolism 35.96 9.89 565 191914 101139 50311506
Pneumonia 35.67 9.89 1770 190709 376631 50036014
Infection 35.21 9.89 455 192024 172499 50240146
Basal cell carcinoma 34.77 9.89 23 192456 23333 50389312
Computerised tomogram thorax abnormal 34.71 9.89 34 192445 1349 50411296
Leukopenia 34.54 9.89 401 192078 67127 50345518
Injection site bruising 34.48 9.89 54 192425 36714 50375931
Lupus vasculitis 34.30 9.89 22 192457 465 50412180
Aplasia 34.16 9.89 56 192423 3757 50408888
Cardiac arrest 33.98 9.89 476 192003 83175 50329470
Hepatic function abnormal 33.60 9.89 45 192434 32636 50380009
Blood potassium decreased 33.43 9.89 248 192231 36697 50375948
Red blood cell count decreased 32.85 9.89 231 192248 33604 50379041
Right ventricular hypertrophy 32.63 9.89 24 192455 638 50412007
Product complaint 32.59 9.89 3 192476 11463 50401182
Pulmonary fibrosis 32.58 9.89 27 192452 24410 50388235
Osteonecrosis 32.42 9.89 23 192456 22494 50390151
Unresponsive to stimuli 32.11 9.89 213 192266 30396 50382249
Apnoea 31.65 9.89 77 192402 6889 50405756
Pedal pulse abnormal 31.65 9.89 14 192465 133 50412512
Wrong technique in product usage process 31.44 9.89 107 192372 55403 50357242
Bone density decreased 31.20 9.89 3 192476 11072 50401573
Gait disturbance 31.13 9.89 393 192086 149612 50263033
Sinusitis 30.68 9.89 460 192019 170098 50242547
Poor feeding infant 30.49 9.89 16 192463 228 50412417
Joint stiffness 29.89 9.89 43 192436 30265 50382380
Left atrial hypertrophy 29.81 9.89 10 192469 40 50412605
Oral pain 29.23 9.89 179 192300 24854 50387791
Sense of oppression 29.04 9.89 26 192453 919 50411726
Neonatal tachypnoea 28.36 9.89 10 192469 48 50412597
Renal impairment 28.33 9.89 170 192309 75491 50337154
Vasculitis 28.23 9.89 9 192470 13982 50398663
Hospitalisation 27.76 9.89 387 192092 67550 50345095
Macular degeneration 27.73 9.89 10 192469 14378 50398267
Ageusia 27.69 9.89 102 192377 11481 50401164
Right ventricular enlargement 27.54 9.89 16 192463 281 50412364
Laevocardia 27.45 9.89 6 192473 0 50412645
Therapy interrupted 27.37 9.89 150 192329 20002 50392643
Type I hypersensitivity 26.95 9.89 39 192440 2346 50410299
International normalised ratio increased 26.66 9.89 80 192399 43072 50369573
Chest discomfort 26.57 9.89 498 191981 92224 50320421
Neutropenic colitis 26.55 9.89 39 192440 2378 50410267
Otitis media acute 26.53 9.89 24 192455 860 50411785
Joint range of motion decreased 26.53 9.89 19 192460 18493 50394152
Sinus tachycardia 26.40 9.89 155 192324 21199 50391446
Blood pressure fluctuation 26.25 9.89 61 192418 35762 50376883
Toxic erythema of chemotherapy 26.16 9.89 12 192467 125 50412520
Bronchospasm 26.15 9.89 119 192360 14735 50397910
Clostridium difficile colitis 26.10 9.89 135 192344 17607 50395038
Medication error 26.04 9.89 62 192417 36042 50376603
Anaphylactic shock 26.03 9.89 148 192331 20007 50392638
Fibromyalgia 25.95 9.89 86 192393 44892 50367753
Acute respiratory failure 25.92 9.89 193 192286 28589 50384056
Cestode infection 25.40 9.89 15 192464 272 50412373
Troponin increased 25.17 9.89 78 192401 8040 50404605
Rhabdomyolysis 25.09 9.89 71 192408 38956 50373689
Taste disorder 24.90 9.89 79 192400 8245 50404400
Pulmonary artery stenosis congenital 24.81 9.89 14 192465 232 50412413
Foot deformity 24.67 9.89 22 192457 19188 50393457
Therapy non-responder 24.59 9.89 105 192374 50917 50361728
Bacteraemia 24.21 9.89 114 192365 14319 50398326
Eustachian tube dysfunction 24.11 9.89 16 192463 359 50412286
Pain in extremity 24.08 9.89 823 191656 272042 50140603
Epistaxis 24.02 9.89 359 192120 63595 50349050
Feeding intolerance 23.76 9.89 18 192461 501 50412144
Gangrene 23.64 9.89 54 192425 4638 50408007
Cerebral microhaemorrhage 23.47 9.89 10 192469 86 50412559
Disease recurrence 23.47 9.89 25 192454 20056 50392589
Bone disorder 23.45 9.89 22 192457 18730 50393915
Device related infection 23.41 9.89 147 192332 20588 50392057
Respiratory distress 23.37 9.89 197 192282 30292 50382353
Pneumonitis 23.33 9.89 192 192287 29318 50383327
Vascular access site thrombosis 23.28 9.89 8 192471 35 50412610
Bursitis 23.24 9.89 30 192449 22105 50390540
Sedation complication 23.12 9.89 3 192476 8763 50403882
Postural orthostatic tachycardia syndrome 22.94 9.89 22 192457 850 50411795
Chest pain 22.80 9.89 855 191624 176027 50236618
Adenoidal hypertrophy 22.26 9.89 8 192471 41 50412604
Mental status changes 22.06 9.89 223 192256 36049 50376596
Ileus 21.83 9.89 104 192375 13125 50399520
Drug eruption 21.82 9.89 35 192444 23571 50389074
Contusion 21.76 9.89 298 192181 111885 50300760
Hypophagia 21.70 9.89 180 192299 27548 50385097
Peripheral swelling 21.60 9.89 607 191872 205329 50207316
Muscle spasms 21.60 9.89 628 191851 124925 50287720
Treatment noncompliance 21.56 9.89 52 192427 30098 50382547
Metastases to meninges 21.56 9.89 32 192447 1970 50410675
Congenital anomaly in offspring 21.51 9.89 11 192468 148 50412497
Bone pain 21.34 9.89 274 192205 46955 50365690
Injection site haemorrhage 21.33 9.89 30 192449 21316 50391329
Right ventricular dilatation 21.24 9.89 22 192457 934 50411711
Interstitial lung disease 21.23 9.89 117 192362 53059 50359586
Hypercholesterolaemia 21.13 9.89 9 192470 11694 50400951
Pharyngeal paraesthesia 21.12 9.89 27 192452 1442 50411203
Laboratory test abnormal 21.12 9.89 156 192323 23052 50389593
Cervix neoplasm 21.10 9.89 12 192467 202 50412443
Alopecia areata 21.03 9.89 26 192453 1342 50411303
Pancreatitis 20.88 9.89 251 192228 42363 50370282
Administration site oedema 20.87 9.89 7 192472 28 50412617
Fracture 20.76 9.89 20 192459 16813 50395832
Plantar erythema 20.64 9.89 12 192467 211 50412434
Malaise 20.53 9.89 1511 190968 334021 50078624
Amputation stump pain 20.49 9.89 7 192472 30 50412615
Jaundice neonatal 20.47 9.89 20 192459 791 50411854
Depressed level of consciousness 20.37 9.89 115 192364 51838 50360807
Hypervolaemia 20.21 9.89 166 192313 25333 50387312
Neurotoxicity 20.21 9.89 110 192369 14630 50398015
Glaucoma 20.10 9.89 18 192461 15668 50396977
Blood magnesium decreased 20.09 9.89 90 192389 11070 50401575
Product dose omission issue 20.08 9.89 873 191606 182965 50229680
Lip pruritus 20.03 9.89 19 192460 724 50411921
Intestinal perforation 20 9.89 86 192393 10393 50402252
Panniculitis 19.98 9.89 4 192475 8499 50404146
Left ventricular dysfunction 19.88 9.89 86 192393 10420 50402225
Ventricular septal defect 19.80 9.89 46 192433 3995 50408650
Nail pigmentation 19.78 9.89 11 192468 177 50412468
Respiratory failure 19.71 9.89 470 192009 90711 50321934
Burkholderia cepacia complex infection 19.66 9.89 10 192469 133 50412512
Vascular access site infection 19.62 9.89 7 192472 35 50412610
Gastroenteritis radiation 19.51 9.89 15 192464 427 50412218
Hydronephrosis 19.41 9.89 74 192405 8467 50404178
Product substitution issue 19.41 9.89 15 192464 14042 50398603
Enterocolitis 19.35 9.89 62 192417 6505 50406140
Lupus-like syndrome 19.34 9.89 6 192473 9485 50403160
Eating disorder 19.15 9.89 112 192367 15297 50397348
Pulmonary valve stenosis 19.04 9.89 13 192466 306 50412339
Computerised tomogram thorax 18.90 9.89 10 192469 145 50412500
Pregnancy 18.87 9.89 54 192425 29523 50383122
Hyperemesis gravidarum 18.82 9.89 16 192463 527 50412118
Sleep disorder 18.76 9.89 134 192345 57149 50355496
Long QT syndrome congenital 18.71 9.89 7 192472 41 50412604
Coma 18.65 9.89 133 192346 56746 50355899
Congenital pulmonary valve atresia 18.65 9.89 8 192471 70 50412575
Creatinine renal clearance decreased 18.65 9.89 11 192468 11870 50400775
Urinary tract infection 18.65 9.89 1036 191443 222984 50189661
Drug dependence 18.55 9.89 29 192450 19730 50392915
Stress cardiomyopathy 18.48 9.89 69 192410 7818 50404827
Paraesthesia 18.43 9.89 593 191886 119650 50292995
Schizophrenia 18.42 9.89 3 192476 7394 50405251
Weight decreased 18.38 9.89 1023 191456 220222 50192423
Bulimia nervosa 18.38 9.89 14 192465 393 50412252
Infective pulmonary exacerbation of cystic fibrosis 18.37 9.89 69 192410 7840 50404805
Drug level increased 18.35 9.89 28 192451 19240 50393405
Ventricular extrasystoles 18.33 9.89 84 192395 10432 50402213
Univentricular heart 18.30 9.89 4 192475 0 50412645
Subchorionic haemorrhage 18.26 9.89 10 192469 156 50412489
Cerebellar stroke 18.22 9.89 11 192468 208 50412437
Metastases to peritoneum 18.20 9.89 36 192443 2797 50409848
Venoocclusive liver disease 18.20 9.89 46 192433 4215 50408430
Cerebral infarction 18.17 9.89 34 192445 21570 50391075
Drug interaction 18.08 9.89 600 191879 199021 50213624
Skin ulcer 18.07 9.89 71 192408 35247 50377398
Laryngeal discomfort 17.97 9.89 12 192467 272 50412373
Drug clearance decreased 17.93 9.89 22 192457 1127 50411518
Oral candidiasis 17.92 9.89 118 192361 16797 50395848
Tryptase increased 17.90 9.89 11 192468 215 50412430
Magnesium deficiency 17.88 9.89 15 192464 485 50412160
Rotator cuff syndrome 17.69 9.89 11 192468 11533 50401112
Injection site warmth 17.66 9.89 16 192463 13850 50398795
Poisoning 17.49 9.89 13 192466 12416 50400229
Transfusion 17.49 9.89 96 192383 12809 50399836
Illness 17.47 9.89 156 192323 24384 50388261
Peripheral sensory neuropathy 17.44 9.89 60 192419 6531 50406114
Infusion site streaking 17.30 9.89 14 192465 430 50412215
Skin necrosis 17.15 9.89 10 192469 10857 50401788
Onychalgia 17.13 9.89 18 192461 777 50411868
Electrolyte imbalance 17.12 9.89 118 192361 17051 50395594
Toxic encephalopathy 17.10 9.89 53 192426 5462 50407183
Paranoia 17.08 9.89 9 192470 10339 50402306
Dysphemia 16.91 9.89 31 192448 2275 50410370
Non-cardiac chest pain 16.78 9.89 54 192425 5678 50406967
Procedural vomiting 16.71 9.89 14 192465 452 50412193
Obstructive airways disorder 16.66 9.89 21 192458 15631 50397014
Osteomyelitis 16.43 9.89 38 192441 22315 50390330
Immune effector cell-associated neurotoxicity syndrome 16.32 9.89 21 192458 1129 50411516
Poor peripheral circulation 16.25 9.89 37 192442 3171 50409474
Sleep disorder due to a general medical condition 16.25 9.89 4 192475 7367 50405278
Tendonitis 16.18 9.89 24 192455 16681 50395964
Premature delivery 16.12 9.89 149 192330 23514 50389131
Gastrostomy tube site complication 16.08 9.89 4 192475 3 50412642
Congenital tongue anomaly 16.08 9.89 4 192475 3 50412642
Dry skin 16.04 9.89 242 192237 42949 50369696
Incorrect route of product administration 16.04 9.89 29 192450 18637 50394008
Hypergeusia 16.00 9.89 5 192474 15 50412630
Cleft palate 15.94 9.89 19 192460 944 50411701
Epiglottic oedema 15.92 9.89 6 192473 36 50412609
Vein discolouration 15.90 9.89 10 192469 204 50412441
Madarosis 15.81 9.89 32 192447 2528 50410117
Feeding disorder 15.78 9.89 81 192398 10532 50402113
Electrolyte depletion 15.75 9.89 9 192470 153 50412492
Carpal tunnel syndrome 15.66 9.89 25 192454 16868 50395777
Migraine 15.65 9.89 386 192093 74894 50337751
Right ventricle outflow tract obstruction 15.55 9.89 4 192475 4 50412641
Pityriasis rosea 15.51 9.89 7 192472 70 50412575
Hyperkalaemia 15.50 9.89 113 192366 47976 50364669
Seizure like phenomena 15.40 9.89 19 192460 979 50411666
Blood bilirubin increased 15.38 9.89 188 192291 31850 50380795
Muscle twitching 15.36 9.89 106 192373 15325 50397320
Full blood count abnormal 15.30 9.89 146 192333 23242 50389403
Premenstrual syndrome 15.28 9.89 15 192464 597 50412048
Hypersensitivity 15.22 9.89 666 191813 214495 50198150
Electrocardiogram PR shortened 15.16 9.89 10 192469 222 50412423
Hot flush 15.08 9.89 244 192235 43925 50368720
Melaena 15.06 9.89 52 192427 26812 50385833
Thrombosis 15.01 9.89 297 192182 55536 50357109
Musculoskeletal pain 14.99 9.89 189 192290 71988 50340657
Plasmacytoma 14.96 9.89 30 192449 2355 50410290
Transplant rejection 14.94 9.89 9 192470 9600 50403045
Tracheal injury 14.90 9.89 6 192473 44 50412601
Joint dislocation 14.81 9.89 15 192464 12318 50400327
Anaphylactoid reaction 14.79 9.89 37 192442 3369 50409276
Electrocardiogram T wave inversion 14.77 9.89 36 192443 3225 50409420
Lipase decreased 14.71 9.89 8 192471 123 50412522
Monocyte count decreased 14.66 9.89 26 192453 1860 50410785
Glioblastoma multiforme 14.66 9.89 16 192463 722 50411923
Liver injury 14.60 9.89 47 192432 24759 50387886
Chronic hepatitis B 14.47 9.89 9 192470 180 50412465
Food intolerance 14.45 9.89 30 192449 2414 50410231
Rash maculo-papular 14.43 9.89 160 192319 26481 50386164
Alopecia totalis 14.37 9.89 11 192468 311 50412334
Stridor 14.37 9.89 35 192444 3134 50409511
Joint effusion 14.35 9.89 17 192462 13004 50399641
Neutrophil count abnormal 14.32 9.89 30 192449 2429 50410216
Right-to-left cardiac shunt 14.25 9.89 9 192470 185 50412460
Uterine perforation 14.10 9.89 55 192424 6360 50406285
Herpes zoster 14.10 9.89 187 192292 70599 50342046
Aphasia 14.03 9.89 168 192311 28326 50384319
IIIrd nerve paresis 14.00 9.89 8 192471 136 50412509
Transmission of an infectious agent via product 14.00 9.89 8 192471 136 50412509
Gait inability 13.96 9.89 83 192396 36944 50375701
Uterine contractions during pregnancy 13.96 9.89 13 192466 484 50412161
Streptococcal bacteraemia 13.86 9.89 22 192457 1436 50411209
Gastroenteropancreatic neuroendocrine tumour disease 13.85 9.89 5 192474 26 50412619
Hypofibrinogenaemia 13.78 9.89 19 192460 1093 50411552
Cytopenia 13.77 9.89 68 192411 8707 50403938
Abdominal distension 13.75 9.89 369 192110 72534 50340111
Foetal damage 13.73 9.89 3 192476 0 50412645
Wolff-Parkinson-White syndrome congenital 13.73 9.89 3 192476 0 50412645
Right ventricular hypertension 13.73 9.89 3 192476 0 50412645
Oedema neonatal 13.73 9.89 3 192476 0 50412645
Pulmonary oedema neonatal 13.73 9.89 3 192476 0 50412645
Myocardial reperfusion injury 13.70 9.89 5 192474 27 50412618
Septic shock 13.69 9.89 299 192180 56876 50355769
Hepatocellular injury 13.67 9.89 155 192324 25792 50386853
Cytomegalovirus infection 13.63 9.89 30 192449 17932 50394713
Dacryostenosis congenital 13.62 9.89 4 192475 9 50412636
Pulmonary valve stenosis congenital 13.55 9.89 8 192471 145 50412500
Hyperbilirubinaemia neonatal 13.51 9.89 11 192468 341 50412304
Tumour lysis syndrome 13.48 9.89 60 192419 7361 50405284
Protein urine 13.45 9.89 14 192465 598 50412047
Anomalous pulmonary venous connection 13.38 9.89 6 192473 59 50412586
Capillary leak syndrome 13.35 9.89 25 192454 1865 50410780
Generalised tonic-clonic seizure 13.34 9.89 156 192323 26154 50386491
Ejection fraction decreased 13.32 9.89 118 192361 18402 50394243
Uterine hypotonus 13.26 9.89 7 192472 101 50412544
Right atrial enlargement 13.20 9.89 7 192472 102 50412543
Delirium 13.17 9.89 88 192391 38104 50374541
Exostosis 13.07 9.89 15 192464 11638 50401007
Developmental delay 12.96 9.89 20 192459 1274 50411371
Neuroleptic malignant syndrome 12.84 9.89 14 192465 11116 50401529
Haematoma 12.81 9.89 66 192413 30444 50382201
Drug reaction with eosinophilia and systemic symptoms 12.79 9.89 60 192419 28364 50384281
Blood pressure diastolic decreased 12.76 9.89 28 192451 16753 50395892
Dementia 12.74 9.89 26 192453 15971 50396674
Pathogen resistance 12.71 9.89 3 192476 5686 50406959
Grunting 12.68 9.89 9 192470 226 50412419
Stress 12.67 9.89 137 192342 53656 50358989
Gastroenteritis viral 12.65 9.89 118 192361 18668 50393977
Hyperlipidaemia 12.64 9.89 30 192449 17460 50395185
Neuralgia 12.62 9.89 133 192346 21730 50390915
Nail infection 12.52 9.89 25 192454 1956 50410689
Cardiac murmur 12.52 9.89 77 192402 10707 50401938
Aggression 12.44 9.89 40 192439 21076 50391569
Deep vein thrombosis 12.42 9.89 366 192113 72938 50339707
Injection site urticaria 12.38 9.89 17 192462 12200 50400445
Stoma obstruction 12.34 9.89 4 192475 14 50412631
Dextrocardia 12.34 9.89 4 192475 14 50412631
Orthostatic hypotension 12.25 9.89 64 192415 29417 50383228
Periorbital cellulitis 12.25 9.89 13 192466 568 50412077
Acute coronary syndrome 12.21 9.89 69 192410 9305 50403340
Injection site phlebitis 12.20 9.89 7 192472 120 50412525
Anaesthetic complication neurological 12.19 9.89 8 192471 176 50412469
Cyanosis 12.11 9.89 99 192380 15085 50397560
Electrocardiogram QT shortened 12.10 9.89 7 192472 122 50412523
Multiple fractures 12.07 9.89 5 192474 6606 50406039
Otorrhoea 12.01 9.89 19 192460 1237 50411408
Skin burning sensation 12.00 9.89 73 192406 10112 50402533
Cytotoxic oedema 11.95 9.89 7 192472 125 50412520
Congenital tricuspid valve atresia 11.94 9.89 5 192474 41 50412604
Haemoglobin decreased 11.92 9.89 595 191884 126621 50286024
Eye irritation 11.91 9.89 30 192449 17110 50395535
Acute myeloid leukaemia 11.87 9.89 98 192381 14976 50397669
Sensitivity to weather change 11.86 9.89 4 192475 5997 50406648
Hallucination, auditory 11.83 9.89 14 192465 10714 50401931
Abdominal infection 11.76 9.89 22 192457 1640 50411005
Disability 11.75 9.89 19 192460 12756 50399889
COVID-19 pneumonia 11.75 9.89 63 192416 8332 50404313
Liver disorder 11.74 9.89 88 192391 37134 50375511
Teething 11.73 9.89 4 192475 17 50412628
Coronary artery occlusion 11.70 9.89 7 192472 7496 50405149
Device malfunction 11.69 9.89 25 192454 15096 50397549
Hyperhidrosis 11.68 9.89 433 192046 88993 50323652
Vascular device infection 11.68 9.89 40 192439 4344 50408301
Pregnancy with advanced maternal age 11.66 9.89 3 192476 3 50412642
Right atrial dilatation 11.64 9.89 13 192466 602 50412043
Malnutrition 11.63 9.89 88 192391 13101 50399544
Myoglobinuria 11.62 9.89 9 192470 259 50412386
Neutrophil percentage abnormal 11.55 9.89 4 192475 18 50412627
Procedural nausea 11.55 9.89 14 192465 708 50411937
Blood pressure diastolic increased 11.53 9.89 7 192472 7436 50405209
Glycosylated haemoglobin increased 11.53 9.89 14 192465 10592 50402053
Pallor 11.52 9.89 137 192342 23062 50389583
Alveolitis 11.50 9.89 28 192451 2506 50410139
Palmar erythema 11.45 9.89 21 192458 1542 50411103
Cyclic vomiting syndrome 11.44 9.89 5 192474 46 50412599
Renal function test abnormal 11.39 9.89 30 192449 2819 50409826
Fever neonatal 11.38 9.89 4 192475 19 50412626
Exposure during pregnancy 11.36 9.89 362 192117 120653 50291992
Intercepted product administration error 11.34 9.89 6 192473 87 50412558
Hair texture abnormal 11.21 9.89 35 192444 3621 50409024
Arterial occlusive disease 11.21 9.89 42 192437 4766 50407879
Congenital anaemia 11.20 9.89 3 192476 4 50412641
Cleft lip and palate 11.18 9.89 10 192469 353 50412292
Grip strength decreased 11.18 9.89 18 192461 12103 50400542
Cancer pain 11.12 9.89 28 192451 2559 50410086
Coeliac disease 11.09 9.89 10 192469 8675 50403970
Pneumonia respiratory syncytial viral 11.05 9.89 13 192466 637 50412008
Haemorrhoids 11.04 9.89 116 192363 18937 50393708
Lymphorrhoea 10.99 9.89 5 192474 51 50412594
Ventricular hypoplasia 10.95 9.89 7 192472 147 50412498
Meningitis streptococcal 10.95 9.89 7 192472 147 50412498
Velopharyngeal incompetence 10.90 9.89 4 192475 22 50412623
Intentional underdose 10.89 9.89 21 192458 1601 50411044
Polymenorrhoea 10.89 9.89 17 192462 1094 50411551
Intensive care 10.89 9.89 9 192470 285 50412360
Weight gain poor 10.88 9.89 14 192465 753 50411892
Hypoglycaemia 10.87 9.89 141 192338 53440 50359205
Arteriospasm coronary 10.84 9.89 33 192446 3369 50409276
Blood creatine increased 10.83 9.89 42 192437 4845 50407800
Lymphocyte count decreased 10.80 9.89 150 192329 26157 50386488
Breast cancer metastatic 10.80 9.89 72 192407 10292 50402353
Hallucination, visual 10.78 9.89 30 192449 16552 50396093
Moaning 10.78 9.89 14 192465 760 50411885
Pulmonary air leakage 10.75 9.89 4 192475 23 50412622
Tracheal deviation 10.74 9.89 5 192474 54 50412591
Arteriosclerosis coronary artery 10.73 9.89 8 192471 7628 50405017
Incorrect dose administered 10.73 9.89 125 192354 48289 50364356
Ulcer 10.73 9.89 40 192439 20160 50392485
Injection site rash 10.72 9.89 29 192450 16148 50396497
Tricuspid valve disease 10.71 9.89 8 192471 218 50412427
Chronic obstructive pulmonary disease 10.70 9.89 141 192338 53294 50359351
Hypothyroidism 10.61 9.89 81 192398 34044 50378601
Coma scale abnormal 10.57 9.89 41 192438 4730 50407915
Sputum abnormal 10.54 9.89 11 192468 471 50412174
Pericardial effusion 10.54 9.89 146 192333 25443 50387202
Biliary catheter insertion 10.47 9.89 4 192475 25 50412620
Intentional product use issue 10.45 9.89 218 192261 76700 50335945
Pneumomediastinum 10.42 9.89 17 192462 1136 50411509
Injection site haematoma 10.41 9.89 5 192474 6055 50406590
Pulse absent 10.40 9.89 41 192438 4765 50407880
Biliary obstruction 10.39 9.89 26 192453 2367 50410278
Wheelchair user 10.39 9.89 3 192476 4969 50407676
Infusion related reaction 10.36 9.89 533 191946 169024 50243621
Complication of device insertion 10.35 9.89 5 192474 6036 50406609
Blood magnesium abnormal 10.32 9.89 11 192468 483 50412162
Sciatica 10.30 9.89 44 192435 21338 50391307
Dysphagia 10.28 9.89 376 192103 77142 50335503
Acute kidney injury 10.28 9.89 1004 191475 227054 50185591
Cleft lip 10.25 9.89 6 192473 107 50412538
High density lipoprotein abnormal 10.21 9.89 5 192474 61 50412584
Vocal cord paralysis 10.20 9.89 21 192458 1680 50410965
Tumour marker increased 10.20 9.89 35 192444 3805 50408840
Gastrointestinal motility disorder 10.19 9.89 39 192440 4470 50408175
Tongue disorder 10.19 9.89 12 192467 9204 50403441
Osteopenia 10.19 9.89 32 192447 16986 50395659
Pulmonary thrombosis 10.15 9.89 56 192423 7485 50405160
Cephalhaematoma 10.14 9.89 3 192476 7 50412638
Enteritis 10.13 9.89 53 192426 6942 50405703
Unintentional medical device removal 10.10 9.89 4 192475 5431 50407214
Catheter site bruise 10.08 9.89 9 192470 317 50412328
Systemic inflammatory response syndrome 10.07 9.89 42 192437 5007 50407638
Cough 9.99 9.89 1056 191423 240208 50172437
Aortic embolus 9.97 9.89 4 192475 29 50412616
Pemphigoid 9.96 9.89 5 192474 5902 50406743
Pharyngeal hypoaesthesia 9.93 9.89 8 192471 244 50412401
Dysuria 9.93 9.89 158 192321 28346 50384299
Large intestine polyp 9.90 9.89 8 192471 7324 50405321
Gastrointestinal haemorrhage 9.90 9.89 208 192271 73113 50339532

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
Febrile neutropenia 639.34 10.58 1347 110194 110893 29352093
Vomiting 404.46 10.58 1726 109815 210534 29252452
Drug ineffective 311.80 10.58 560 110981 362610 29100376
Nausea 292.32 10.58 1976 109565 287279 29175707
Completed suicide 230.78 10.58 33 111508 90213 29372773
Drug abuse 230.13 10.58 19 111522 79864 29383122
Toxicity to various agents 200.22 10.58 216 111325 173445 29289541
Serotonin syndrome 166.63 10.58 263 111278 17249 29445737
Left-to-right cardiac shunt 148.02 10.58 35 111506 15 29462971
Pyrexia 134.68 10.58 1665 109876 285957 29177029
Neutropenia 131.17 10.58 898 110643 130813 29332173
Constipation 126.80 10.58 800 110741 113360 29349626
Diarrhoea 124.21 10.58 1849 109692 330849 29132137
Fatigue 122.66 10.58 1772 109769 315049 29147937
Plasma cell myeloma 118.37 10.58 358 111183 36757 29426229
Cytokine release syndrome 115.21 10.58 190 111351 12929 29450057
Myocardial infarction 111.27 10.58 152 111389 110144 29352842
Febrile bone marrow aplasia 109.66 10.58 137 111404 7214 29455772
Aplastic anaemia 101.08 10.58 133 111408 7377 29455609
Heart disease congenital 98.57 10.58 61 111480 1219 29461767
Otitis media chronic 96.37 10.58 27 111514 48 29462938
Thrombocytopenia 93.68 10.58 846 110695 133977 29329009
Abdominal pain 91.33 10.58 844 110697 134513 29328473
Overdose 89.92 10.58 101 111440 79718 29383268
Rhabdomyolysis 89.02 10.58 60 111481 60748 29402238
Congenital anomaly 84.22 10.58 56 111485 1272 29461714
Dehydration 83.79 10.58 728 110813 114020 29348966
Suicide attempt 83.65 10.58 14 111527 34096 29428890
Condition aggravated 81.48 10.58 281 111260 146014 29316972
Electrocardiogram QT prolonged 79.54 10.58 308 111233 35829 29427157
Appendicolith 77.75 10.58 80 111461 3400 29459586
Intentional overdose 76.37 10.58 25 111516 38503 29424483
Coronary artery disease 75.57 10.58 36 111505 44154 29418832
Chills 74.96 10.58 493 111048 70807 29392179
Blood creatine phosphokinase increased 72.81 10.58 31 111510 40613 29422373
Disease progression 71.28 10.58 541 111000 81375 29381611
Flushing 69.52 10.58 254 111287 28738 29434248
Sepsis 69.05 10.58 832 110709 141850 29321136
Rheumatoid arthritis 68.97 10.58 18 111523 32134 29430852
Mucosal inflammation 68.48 10.58 268 111273 31327 29431659
Failure to thrive 67.07 10.58 111 111430 7573 29455413
Therapeutic product effect incomplete 65.72 10.58 33 111508 39272 29423714
Decreased appetite 64.53 10.58 834 110707 144508 29318478
Hospice care 62.47 10.58 86 111455 4982 29458004
Drug resistance 62.33 10.58 5 111536 21535 29441451
Torsade de pointes 60.55 10.58 98 111443 6563 29456423
Erythema 57.93 10.58 485 111056 75121 29387865
Death 56.03 10.58 1686 109855 340398 29122588
Treatment failure 54.65 10.58 36 111505 36903 29426083
Arthralgia 53.07 10.58 309 111232 139308 29323678
White blood cell count decreased 52.26 10.58 512 111029 82850 29380136
Hypoxia 50.61 10.58 329 111212 47050 29415936
Appendicitis 49.32 10.58 105 111436 8674 29454312
Interstitial lung disease 49.16 10.58 89 111452 57629 29405357
Hepatic function abnormal 47.18 10.58 47 111494 39212 29423774
Aggression 46.94 10.58 39 111502 35502 29427484
Musculoskeletal stiffness 45.99 10.58 44 111497 37414 29425572
Aplasia 45.71 10.58 66 111475 3997 29458989
Neuropathy peripheral 43.90 10.58 435 111106 70592 29392394
Tachycardia 43.08 10.58 440 111101 71970 29391016
Ventricular tachyarrhythmia 41.61 10.58 21 111520 277 29462709
Suicidal ideation 41.21 10.58 42 111499 34674 29428312
Encephalopathy 41.10 10.58 228 111313 30815 29432171
Neutrophil count decreased 40.86 10.58 293 111248 43274 29419712
Stomatitis 40.42 10.58 259 111282 36854 29426132
Wrong technique in product usage process 39.66 10.58 36 111505 31392 29431594
Psoriasis 39.39 10.58 38 111503 32189 29430797
Eustachian tube dysfunction 39.27 10.58 13 111528 50 29462936
Right ventricular hypertrophy 38.03 10.58 33 111508 1128 29461858
Full blood count decreased 37.39 10.58 139 111402 15853 29447133
Hypersensitivity 37.17 10.58 333 111208 52570 29410416
Laevocardia 36.67 10.58 8 111533 0 29462986
Coma 36.18 10.58 58 111483 39392 29423594
Small intestinal obstruction 36.13 10.58 120 111421 12941 29450045
Acute myocardial infarction 35.85 10.58 81 111460 48357 29414629
Intentional product misuse 35.68 10.58 47 111494 34614 29428372
Therapeutic response decreased 35.32 10.58 25 111516 24686 29438300
Otitis media acute 35.23 10.58 22 111519 447 29462539
Myalgia 34.83 10.58 152 111389 73867 29389119
Depression 34.75 10.58 184 111357 84963 29378023
Right ventricular enlargement 34.49 10.58 16 111525 173 29462813
Malignant neoplasm progression 34.48 10.58 428 111113 73431 29389555
Ventricular fibrillation 34.05 10.58 134 111407 15699 29447287
Cardiac failure congestive 33.81 10.58 161 111380 76420 29386566
Adenoidal hypertrophy 33.31 10.58 14 111527 117 29462869
Drug dependence 33.04 10.58 19 111522 20962 29442024
Inappropriate schedule of product administration 32.40 10.58 75 111466 44397 29418589
Atelectasis neonatal 32.09 10.58 7 111534 0 29462986
Diabetes mellitus 31.65 10.58 64 111477 39767 29423219
Malignant catatonia 31.44 10.58 16 111525 215 29462771
Renal impairment 31.41 10.58 179 111362 81154 29381832
Platelet count decreased 31.39 10.58 562 110979 104110 29358876
Dry skin 31.39 10.58 172 111369 23135 29439851
Therapeutic product effect decreased 31.28 10.58 39 111502 29412 29433574
Oropharyngeal discomfort 30.94 10.58 43 111498 2513 29460473
Intentional self-injury 30.80 10.58 5 111536 12456 29450530
Weight increased 30.54 10.58 167 111374 76500 29386486
Injection site pain 30.42 10.58 47 111494 32399 29430587
Bacteraemia 30.27 10.58 132 111409 16191 29446795
Cerebral infarction 30.27 10.58 29 111512 24646 29438340
Pulmonary artery stenosis congenital 29.63 10.58 20 111521 466 29462520
Anaphylactic reaction 29.15 10.58 191 111350 27382 29435604
Negative pressure pulmonary oedema 29.06 10.58 15 111526 208 29462778
Impaired gastric emptying 29.04 10.58 46 111495 3024 29459962
Oral pain 28.92 10.58 89 111452 9218 29453768
Oxygen saturation immeasurable 28.88 10.58 9 111532 27 29462959
Colitis 28.63 10.58 209 111332 31039 29431947
Pneumonia 28.58 10.58 1478 110063 318694 29144292
Cleft palate 28.56 10.58 21 111520 563 29462423
Poor feeding infant 28.44 10.58 19 111522 435 29462551
Angina pectoris 28.42 10.58 38 111503 27812 29435174
Psoriatic arthropathy 28.30 10.58 10 111531 14681 29448305
Hypotension 28.27 10.58 945 110596 193409 29269577
Clostridium difficile infection 28.03 10.58 128 111413 16013 29446973
Right-to-left cardiac shunt 27.79 10.58 10 111531 52 29462934
Angina unstable 27.68 10.58 4 111537 10861 29452125
Erectile dysfunction 27.39 10.58 17 111524 17992 29444994
Pancytopenia 27.26 10.58 453 111088 82715 29380271
Asthma 27.23 10.58 54 111487 33795 29429191
Atrial septal defect 27.03 10.58 71 111470 6718 29456268
Chemotherapeutic drug level increased 27.00 10.58 14 111527 196 29462790
Cardiac failure 26.72 10.58 182 111359 79105 29383881
Dermatitis diaper 26.52 10.58 15 111526 252 29462734
Asthenia 26.50 10.58 1027 110514 214223 29248763
Blood pressure measurement 26.48 10.58 13 111528 161 29462825
Hyperbilirubinaemia 26.35 10.58 119 111422 14815 29448171
Hypoplastic left heart syndrome 25.86 10.58 14 111527 215 29462771
Hyponatraemia 25.82 10.58 378 111163 67255 29395731
Labelled drug-drug interaction medication error 25.71 10.58 7 111534 12152 29450834
Developmental delay 25.59 10.58 39 111502 2479 29460507
Platelet transfusion 25.59 10.58 26 111515 1088 29461898
Croup infectious 25.57 10.58 15 111526 271 29462715
Synovitis 25.55 10.58 5 111536 10885 29452101
Fear 25.41 10.58 3 111538 9501 29453485
Melaena 24.85 10.58 50 111491 31126 29431860
Neurotoxicity 24.72 10.58 115 111426 14498 29448488
Stridor 24.36 10.58 36 111505 2227 29460759
Cerebrovascular accident 24.24 10.58 180 111361 76731 29386255
Infusion related reaction 23.89 10.58 262 111279 43624 29419362
Multiple congenital abnormalities 23.74 10.58 18 111523 506 29462480
Gastrointestinal haemorrhage 23.72 10.58 189 111352 79344 29383642
Loss of personal independence in daily activities 23.71 10.58 37 111504 25403 29437583
Immune-mediated hepatitis 23.64 10.58 29 111512 1498 29461488
Fall 23.64 10.58 499 111042 176679 29286307
Right aortic arch 23.53 10.58 7 111534 17 29462969
Electrocardiogram T wave biphasic 23.27 10.58 12 111529 166 29462820
Coarctation of the aorta 23.24 10.58 17 111524 452 29462534
Painful respiration 22.70 10.58 25 111516 1149 29461837
Blood glucose increased 22.66 10.58 130 111411 58854 29404132
Blood pressure fluctuation 22.57 10.58 25 111516 19869 29443117
Altered state of consciousness 22.55 10.58 25 111516 19864 29443122
Periorbital swelling 22.39 10.58 15 111526 345 29462641
Upper respiratory tract infection 22.29 10.58 178 111363 27171 29435815
Diabetes mellitus inadequate control 22.13 10.58 9 111532 12125 29450861
Sepsis neonatal 22.10 10.58 13 111528 236 29462750
Joint swelling 22.09 10.58 104 111437 49526 29413460
Blood cholesterol increased 22.00 10.58 16 111525 15579 29447407
Right ventricular dilatation 21.86 10.58 18 111523 572 29462414
Type 2 diabetes mellitus 21.81 10.58 12 111529 13569 29449417
Hyperthermia malignant 21.58 10.58 30 111511 1754 29461232
Neoplasm progression 21.57 10.58 132 111409 18480 29444506
Endocardial fibroelastosis 21.30 10.58 6 111535 11 29462975
Cleft lip 21.28 10.58 14 111527 312 29462674
Enteritis 21.16 10.58 65 111476 6726 29456260
Blood triglycerides increased 21.11 10.58 11 111530 12823 29450163
Coronary artery occlusion 20.99 10.58 6 111535 10088 29452898
Treatment noncompliance 20.94 10.58 37 111504 24190 29438796
Feeling hot 20.65 10.58 114 111427 15374 29447612
Paranoia 20.30 10.58 6 111535 9871 29453115
Post procedural hypotension 20.25 10.58 8 111533 56 29462930
Clostridium difficile colitis 20.20 10.58 101 111440 13111 29449875
Disturbance in attention 20.11 10.58 31 111510 21393 29441593
Drug interaction 20.04 10.58 579 110962 196806 29266180
Feeding disorder 20.02 10.58 58 111483 5809 29457177
Testicular germ cell cancer metastatic 20.01 10.58 8 111533 58 29462928
Hypoplastic right heart syndrome 19.77 10.58 6 111535 16 29462970
Necrotising retinitis 19.64 10.58 19 111522 749 29462237
Osteoarthritis 19.19 10.58 24 111517 18079 29444907
Oxygen saturation decreased 19.10 10.58 256 111285 44681 29418305
Tumour lysis syndrome 19.06 10.58 103 111438 13781 29449205
Parainfluenzae virus infection 18.97 10.58 32 111509 2217 29460769
Clonus 18.96 10.58 33 111508 2345 29460641
Change of bowel habit 18.94 10.58 21 111520 973 29462013
Skin ulcer 18.93 10.58 26 111515 18814 29444172
Laryngeal discomfort 18.92 10.58 10 111531 146 29462840
Klebsiella bacteraemia 18.74 10.58 22 111519 1085 29461901
Cytomegalovirus infection 18.70 10.58 37 111504 23178 29439808
Gastrointestinal malformation 18.63 10.58 7 111534 42 29462944
Angioedema 18.61 10.58 60 111481 31855 29431131
Erythropenia 18.54 10.58 11 111530 203 29462783
Hypokalaemia 18.53 10.58 279 111262 49924 29413062
Abnormal behaviour 18.51 10.58 37 111504 23090 29439896
Impetigo 18.41 10.58 20 111521 905 29462081
Embryonal rhabdomyosarcoma 18.34 10.58 4 111537 0 29462986
Therapy non-responder 18.10 10.58 58 111483 30853 29432133
Tubulointerstitial nephritis 18.08 10.58 24 111517 17619 29445367
Neonatal tachypnoea 17.95 10.58 10 111531 163 29462823
Pulse absent 17.89 10.58 51 111490 5062 29457924
Ascites 17.85 10.58 214 111327 36405 29426581
Prostate cancer 17.84 10.58 44 111497 25483 29437503
Adverse drug reaction 17.79 10.58 153 111388 23867 29439119
Psychotic disorder 17.67 10.58 31 111510 20323 29442663
Arteriosclerosis coronary artery 17.58 10.58 9 111532 10596 29452390
Somnolence 17.55 10.58 249 111292 93706 29369280
Deep vein thrombosis 17.47 10.58 309 111232 57090 29405896
Injection site haemorrhage 17.41 10.58 5 111536 8381 29454605
Myopathy 17.37 10.58 9 111532 10524 29452462
Heart rate decreased 17.36 10.58 43 111498 24869 29438117
Perihepatic abscess 17.29 10.58 8 111533 86 29462900
Fixed eruption 17.29 10.58 22 111519 1180 29461806
Abdominal distension 17.28 10.58 256 111285 45655 29417331
Congenital aortic stenosis 17.13 10.58 8 111533 88 29462898
Palmar erythema 17.09 10.58 11 111530 236 29462750
Taste disorder 17.06 10.58 48 111493 4728 29458258
Obesity 16.91 10.58 8 111533 9855 29453131
Lactic acidosis 16.86 10.58 58 111483 30189 29432797
Hypoglycaemia 16.77 10.58 110 111431 48236 29414750
Meconium abnormal 16.71 10.58 7 111534 58 29462928
Walking aid user 16.63 10.58 24 111517 1453 29461533
Electrocardiogram QT shortened 16.52 10.58 9 111532 140 29462846
Osteonecrosis 16.45 10.58 16 111525 13503 29449483
Incarcerated umbilical hernia 16.30 10.58 5 111536 14 29462972
Univentricular heart 16.25 10.58 6 111535 34 29462952
Neutropenic colitis 16.12 10.58 31 111510 2380 29460606
Pulmonary oedema neonatal 16.11 10.58 4 111537 3 29462983
Product dose omission issue 16.09 10.58 261 111280 96122 29366864
Tendonitis 16.07 10.58 5 111536 7956 29455030
Drug ineffective for unapproved indication 15.97 10.58 18 111523 14196 29448790
International normalised ratio increased 15.88 10.58 100 111441 44272 29418714
Extravasation 15.74 10.58 25 111516 1647 29461339
Hyperaemia 15.74 10.58 19 111522 965 29462021
Urethral valves 15.73 10.58 11 111530 272 29462714
Bradycardia 15.64 10.58 165 111376 65464 29397522
Liver disorder 15.61 10.58 53 111488 27696 29435290
Ageusia 15.60 10.58 71 111470 8867 29454119
Right ventricle outflow tract obstruction 15.58 10.58 4 111537 4 29462982
Ventricular hypoplasia 15.57 10.58 7 111534 70 29462916
Stoma site pain 15.50 10.58 14 111527 505 29462481
Schizophrenia 15.43 10.58 3 111538 6562 29456424
Rash 15.42 10.58 869 110672 188950 29274036
Velopharyngeal incompetence 15.36 10.58 5 111536 18 29462968
Back pain 15.25 10.58 499 111042 101785 29361201
Anomalous pulmonary venous connection 15.23 10.58 7 111534 74 29462912
Road traffic accident 15.11 10.58 22 111519 15539 29447447
Dysgeusia 15.04 10.58 141 111400 22533 29440453
Pain in extremity 15.00 10.58 310 111231 110123 29352863
Right atrial enlargement 14.97 10.58 10 111531 229 29462757
Depressed level of consciousness 14.96 10.58 80 111461 36862 29426124
Electrocardiogram ST segment elevation 14.94 10.58 44 111497 4448 29458538
Haemorrhage 14.91 10.58 104 111437 44968 29418018
Product substitution issue 14.88 10.58 8 111533 9164 29453822
Mental status changes 14.85 10.58 199 111342 34728 29428258
Hyperkalaemia 14.77 10.58 154 111387 61238 29401748
Hypervolaemia 14.74 10.58 115 111426 17430 29445556
Catheter site pain 14.72 10.58 20 111521 1144 29461842
Coronary artery stenosis 14.63 10.58 7 111534 8566 29454420
Myoclonus 14.56 10.58 93 111448 13216 29449770
Atrioventricular block complete 14.52 10.58 6 111535 8005 29454981
Aorta hypoplasia 14.45 10.58 7 111534 84 29462902
Poisoning 14.42 10.58 10 111531 9983 29453003
C-reactive protein increased 14.22 10.58 103 111438 44160 29418826
Eosinophil count increased 14.22 10.58 5 111536 7364 29455622
Glycosylated haemoglobin increased 14.19 10.58 9 111532 9417 29453569
Incorrect dose administered 14.16 10.58 70 111471 32914 29430072
Product administration error 14.12 10.58 20 111521 14290 29448696
Tympanic membrane perforation 14.10 10.58 10 111531 253 29462733
Osteoporosis 13.99 10.58 12 111529 10757 29452229
Injury 13.94 10.58 121 111420 18925 29444061
Cardiac arrest 13.93 10.58 422 111119 85169 29377817
Faeces discoloured 13.84 10.58 18 111523 13333 29449653
Tachypnoea 13.78 10.58 101 111440 15014 29447972
Dyslipidaemia 13.77 10.58 3 111538 6058 29456928
Cardiac malposition 13.75 10.58 3 111538 0 29462986
Cardiomyopathy neonatal 13.75 10.58 3 111538 0 29462986
Hemiplegic migraine 13.75 10.58 3 111538 0 29462986
Adenoiditis 13.75 10.58 3 111538 0 29462986
Joint range of motion decreased 13.75 10.58 3 111538 6051 29456935
Embolism 13.74 10.58 57 111484 6839 29456147
Tuberculosis 13.68 10.58 5 111536 7191 29455795
Subileus 13.66 10.58 32 111509 2818 29460168
Large intestine anastomosis 13.52 10.58 6 111535 58 29462928
Cyanosis neonatal 13.51 10.58 10 111531 271 29462715
Epilepsy 13.49 10.58 31 111510 18401 29444585
Hypophagia 13.45 10.58 129 111412 20743 29442243
Obstructive airways disorder 13.45 10.58 13 111528 11003 29451983
Hot flush 13.35 10.58 99 111442 14771 29448215
Sinus tachycardia 13.35 10.58 100 111441 14969 29448017
Pulmonary valve incompetence 13.23 10.58 15 111526 712 29462274
Oesophageal irritation 13.17 10.58 6 111535 62 29462924
Laryngospasm 13.14 10.58 20 111521 1270 29461716
Gait disturbance 13.13 10.58 196 111345 73153 29389833
Anger 13.12 10.58 13 111528 10877 29452109
Exposure during pregnancy 13.11 10.58 8 111533 8546 29454440
Oedema peripheral 13.11 10.58 294 111247 103263 29359723
Seminoma 13.10 10.58 9 111532 216 29462770
Cardiogenic shock 13.06 10.58 120 111421 19070 29443916
Device malfunction 12.98 10.58 8 111533 8499 29454487
Neutropenic infection 12.94 10.58 20 111521 1287 29461699
Unresponsive to stimuli 12.76 10.58 148 111393 24978 29438008
Pseudomonal bacteraemia 12.75 10.58 17 111524 955 29462031
Patent ductus arteriosus 12.72 10.58 33 111508 3098 29459888
Nephrotic syndrome 12.72 10.58 4 111537 6324 29456662
Otorrhoea 12.68 10.58 12 111529 460 29462526
Urine sodium decreased 12.66 10.58 8 111533 166 29462820
Cardiac murmur 12.66 10.58 54 111487 6559 29456427
Arthritis 12.61 10.58 50 111491 24969 29438017
Visual acuity reduced 12.60 10.58 23 111518 14853 29448133
Septic shock 12.59 10.58 317 111224 62243 29400743
Depressed mood 12.58 10.58 27 111514 16421 29446565
Therapeutic product effect prolonged 12.54 10.58 9 111532 232 29462754
Palmar-plantar erythrodysaesthesia syndrome 12.54 10.58 97 111444 14662 29448324
Photosensitivity reaction 12.42 10.58 10 111531 9248 29453738
Cataract 12.41 10.58 43 111498 22335 29440651
Viral rash 12.39 10.58 6 111535 72 29462914
Neonatal tachycardia 12.37 10.58 4 111537 14 29462972
Chronic obstructive pulmonary disease 12.35 10.58 97 111444 40858 29422128
Malnutrition 12.30 10.58 77 111464 10864 29452122
Cardiac ventricular disorder 12.28 10.58 9 111532 240 29462746
Anaesthetic complication neurological 12.22 10.58 10 111531 315 29462671
Locked-in syndrome 12.22 10.58 9 111532 242 29462744
Phimosis 12.21 10.58 14 111527 673 29462313
Medical device site fistula 12.19 10.58 5 111536 39 29462947
Respiratory arrest 12.17 10.58 53 111488 25780 29437206
Ventricular septal defect 12.15 10.58 35 111506 3494 29459492
Hepatocellular injury 12.10 10.58 128 111413 21115 29441871
Hyperlipidaemia 12.03 10.58 18 111523 12572 29450414
Congenital hypothyroidism 11.96 10.58 4 111537 16 29462970
Pharyngitis streptococcal 11.96 10.58 25 111516 2039 29460947
Benign prostatic hyperplasia 11.92 10.58 16 111525 11694 29451292
Pathogen resistance 11.88 10.58 8 111533 8108 29454878
Fracture 11.86 10.58 4 111537 6049 29456937
Dementia 11.80 10.58 16 111525 11642 29451344
Oral candidiasis 11.77 10.58 75 111466 10647 29452339
Trismus 11.77 10.58 27 111514 2346 29460640
Enterocolitis infectious 11.76 10.58 19 111522 1270 29461716
Muscle rigidity 11.71 10.58 68 111473 9343 29453643
Upper airway obstruction 11.71 10.58 13 111528 603 29462383
Cytokine storm 11.69 10.58 13 111528 604 29462382
Injection site reaction 11.69 10.58 15 111526 11173 29451813
Urinary tract infection neonatal 11.68 10.58 3 111538 3 29462983
Granulocytopenia 11.68 10.58 4 111537 5990 29456996
Chest injury 11.58 10.58 20 111521 1413 29461573
Hyperhidrosis 11.53 10.58 322 111219 64218 29398768
Kidney transplant rejection 11.53 10.58 6 111535 6999 29455987
Abdominal compartment syndrome 11.51 10.58 15 111526 824 29462162
Cytopenia 11.47 10.58 70 111471 9789 29453197
Diaphragmatic rupture 11.41 10.58 4 111537 19 29462967
Red blood cell sedimentation rate increased 11.40 10.58 7 111534 7454 29455532
Therapy interrupted 11.36 10.58 62 111479 8324 29454662
Hyperbilirubinaemia neonatal 11.34 10.58 14 111527 728 29462258
Underdose 11.31 10.58 17 111524 11852 29451134
Otitis media 11.26 10.58 28 111513 2561 29460425
Necrotising enterocolitis neonatal 11.26 10.58 8 111533 203 29462783
Antithrombin III deficiency 11.21 10.58 6 111535 90 29462896
Pulmonary sepsis 11.21 10.58 23 111518 1851 29461135
Nasopharyngitis 11.18 10.58 158 111383 59507 29403479
Paraesthesia 11.17 10.58 274 111267 53571 29409415
Tardive dyskinesia 11.17 10.58 3 111538 5255 29457731
Sexual dysfunction 11.12 10.58 4 111537 5810 29457176
Knee arthroplasty 11.11 10.58 4 111537 5805 29457181
Transplant rejection 11.10 10.58 11 111530 9201 29453785
Conductive deafness 11.09 10.58 7 111534 145 29462841
Anaphylactoid shock 11.09 10.58 10 111531 360 29462626
Large intestinal obstruction 11.07 10.58 19 111522 1335 29461651
Hypophosphataemia 11.02 10.58 59 111482 7865 29455121
Immune reconstitution inflammatory syndrome 11.01 10.58 8 111533 7794 29455192
Infusion site urticaria 10.98 10.58 6 111535 94 29462892
Respiratory rate increased 10.95 10.58 10 111531 8698 29454288
Mobility decreased 10.90 10.58 55 111486 25725 29437261
Acute sinusitis 10.90 10.58 18 111523 1226 29461760
Parkinsonism 10.89 10.58 7 111534 7271 29455715
Poisoning deliberate 10.87 10.58 4 111537 5727 29457259
Glomerular filtration rate decreased 10.87 10.58 16 111525 11250 29451736
Drug eruption 10.82 10.58 30 111511 16711 29446275
Spinal cord injury thoracic 10.81 10.58 6 111535 97 29462889
Thrombosis 10.80 10.58 225 111316 42820 29420166
Right atrial dilatation 10.77 10.58 9 111532 292 29462694
Speech sound disorder 10.72 10.58 7 111534 154 29462832
Epistaxis 10.70 10.58 263 111278 51441 29411545
Micrognathia 10.59 10.58 9 111532 299 29462687

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
Febrile neutropenia 1377.30 9.91 2521 243250 185136 64067825
Drug ineffective 810.76 9.91 1222 244549 839025 63413936
Vomiting 764.91 9.91 4120 241651 546997 63705964
Nausea 645.04 9.91 5147 240624 780653 63472308
Drug abuse 393.04 9.91 29 245742 132345 64120616
Neutropenia 361.30 9.91 1836 243935 237788 64015173
Constipation 342.09 9.91 1752 244019 227585 64025376
Diarrhoea 338.66 9.91 4218 241553 718486 63534475
Toxicity to various agents 324.88 9.91 554 245217 362959 63890002
Synovitis 324.47 9.91 12 245759 99078 64153883
Serotonin syndrome 318.39 9.91 552 245219 38730 64214231
Completed suicide 313.51 9.91 238 245533 224176 64028785
Joint swelling 300.12 9.91 229 245542 215153 64037808
Dehydration 293.80 9.91 1613 244158 215150 64037811
Abdominal pain 286.52 9.91 2104 243667 310271 63942690
Thrombocytopenia 269.64 9.91 1614 244157 222187 64030774
Rheumatoid arthritis 269.42 9.91 145 245626 164149 64088812
Torsade de pointes 261.80 9.91 327 245444 17036 64235925
Disease progression 235.69 9.91 1117 244654 140563 64112398
Arthropathy 224.21 9.91 90 245681 120877 64132084
Therapeutic product effect decreased 223.51 9.91 80 245691 115271 64137690
Electrocardiogram QT prolonged 220.96 9.91 736 245035 78712 64174249
Treatment failure 214.74 9.91 88 245683 116728 64136233
Contraindicated product administered 213.72 9.91 72 245699 107757 64145204
Drug intolerance 212.18 9.91 242 245529 187750 64065211
Pyrexia 212.14 9.91 3142 242629 555502 63697459
Hand deformity 211.19 9.91 6 245765 62765 64190196
Febrile bone marrow aplasia 211.11 9.91 237 245534 11018 64241943
Arthralgia 207.74 9.91 923 244848 441337 63811624
Flushing 198.98 9.91 706 245065 77942 64175019
Mucosal inflammation 198.85 9.91 607 245164 61977 64190984
Erythema 196.49 9.91 1303 244468 185767 64067194
Cytokine release syndrome 191.84 9.91 310 245461 20519 64232442
Hypoxia 178.36 9.91 737 245034 87412 64165549
Systemic lupus erythematosus 177.86 9.91 39 245732 77573 64175388
Plasma cell myeloma 177.52 9.91 479 245292 45596 64207365
White blood cell count decreased 166.67 9.91 1101 244670 156736 64096225
Sepsis 164.96 9.91 1467 244304 228874 64024087
Aplastic anaemia 161.99 9.91 231 245540 13689 64239272
Encephalopathy 158.30 9.91 539 245232 58280 64194681
Overdose 149.91 9.91 235 245536 159331 64093630
Fatigue 149.60 9.91 3819 241952 744911 63508050
Chills 147.63 9.91 962 244809 136302 64116659
Musculoskeletal stiffness 147.40 9.91 151 245620 123055 64129906
Myocardial infarction 144.85 9.91 256 245515 165565 64087396
Neuropathy peripheral 137.76 9.91 842 244929 116683 64136278
Small intestinal obstruction 136.29 9.91 287 245484 23286 64229675
Intentional overdose 135.22 9.91 88 245683 89856 64163105
Therapeutic product effect incomplete 134.11 9.91 118 245653 103364 64149597
Decreased appetite 132.60 9.91 1646 244125 279643 63973318
Neutrophil count decreased 121.33 9.91 599 245172 76597 64176364
Condition aggravated 121.12 9.91 876 244895 371550 63881411
Wound 118.85 9.91 72 245699 76405 64176556
Death 117.88 9.91 2533 243238 480172 63772789
Pericarditis 116.64 9.91 46 245725 62470 64190491
Colitis 112.75 9.91 483 245288 58191 64194770
Hospice care 112.38 9.91 142 245629 7483 64245478
Swelling 110.92 9.91 282 245489 159936 64093025
Coronary artery disease 108.66 9.91 47 245724 60386 64192575
Tachycardia 107.66 9.91 954 244817 148625 64104336
Helicobacter infection 106.76 9.91 11 245760 38351 64214610
Weight increased 104.98 9.91 437 245334 212911 64040050
Rhabdomyolysis 103.50 9.91 118 245653 91608 64161353
Drug hypersensitivity 101.62 9.91 513 245258 237302 64015659
Duodenal ulcer perforation 101.55 9.91 8 245763 34617 64218344
Neutropenic sepsis 98.88 9.91 251 245520 23021 64229940
Suicide attempt 98.14 9.91 76 245695 70931 64182030
Nasopharyngitis 98.09 9.91 399 245372 195674 64057287
Ventricular tachycardia 95.71 9.91 318 245453 33947 64219014
Glossodynia 94.94 9.91 65 245706 64631 64188330
Impaired healing 93.87 9.91 57 245714 60416 64192545
Ventricular fibrillation 92.84 9.91 249 245522 23611 64229350
Injection site pain 91.93 9.91 178 245593 111230 64141731
Asthma 90.58 9.91 139 245632 95086 64157875
Drug resistance 90.48 9.91 13 245758 35089 64217872
Intentional self-injury 90.21 9.91 5 245766 29039 64223922
Blood cholesterol increased 89.91 9.91 39 245732 50027 64202934
Hepatic enzyme increased 89.70 9.91 229 245542 129714 64123247
Pancytopenia 87.65 9.91 883 244888 142426 64110535
Mobility decreased 85.85 9.91 121 245650 85719 64167242
Sleep disorder due to general medical condition, insomnia type 83.24 9.91 4 245767 26266 64226695
Neoplasm progression 83.20 9.91 343 245428 40621 64212340
Aplasia 80.33 9.91 115 245656 6838 64246123
Hepatic function abnormal 78.98 9.91 77 245694 64236 64188725
Muscle injury 77.83 9.91 6 245765 26431 64226530
Appendicolith 77.26 9.91 80 245691 3389 64249572
Platelet count decreased 77.02 9.91 977 244794 166734 64086227
C-reactive protein abnormal 76.66 9.91 10 245761 29037 64223924
Sopor 76.42 9.91 11 245760 29650 64223311
Anaphylactic reaction 75.45 9.91 484 245287 68180 64184781
Asthenia 74.97 9.91 2148 243623 425896 63827065
Feeling hot 73.64 9.91 357 245414 45306 64207655
Fall 73.00 9.91 1133 244638 415693 63837268
Therapeutic response decreased 69.44 9.91 58 245713 52130 64200831
Failure to thrive 68.86 9.91 134 245637 10270 64242691
Oxygen saturation decreased 68.73 9.91 667 245104 106509 64146452
Anaemia 68.42 9.91 1908 243863 376772 63876189
Full blood count decreased 67.96 9.91 215 245556 22367 64230594
Ventricular tachyarrhythmia 66.76 9.91 28 245743 230 64252731
Intentional product misuse 65.47 9.91 109 245662 72186 64180775
Malignant neoplasm progression 65.44 9.91 688 245083 112183 64140778
Laryngospasm 65.39 9.91 73 245698 3372 64249589
Osteoporosis 64.84 9.91 40 245731 42040 64210921
Hypokalaemia 64.21 9.91 729 245042 121174 64131787
Dysgeusia 64.16 9.91 351 245420 46696 64206265
Injection site swelling 64.15 9.91 39 245732 41314 64211647
Clonus 63.81 9.91 96 245675 5971 64246990
Type 2 diabetes mellitus 63.51 9.91 25 245746 33995 64218966
Hypotension 63.44 9.91 1900 243871 379074 63873887
Red blood cell sedimentation rate increased 63.37 9.91 20 245751 31215 64221746
Leukopenia 62.93 9.91 626 245145 100616 64152345
Clostridium difficile infection 62.89 9.91 289 245482 35874 64217087
Pneumonia 59.52 9.91 2653 243118 556923 63696038
Ascites 57.97 9.91 420 245351 61581 64191380
Renal impairment 57.19 9.91 292 245479 134725 64118236
Injection site erythema 56.77 9.91 115 245656 70685 64182276
Long QT syndrome 56.46 9.91 83 245688 5056 64247905
Loss of personal independence in daily activities 55.32 9.91 121 245650 72333 64180628
Osteoarthritis 55.06 9.91 98 245673 63238 64189723
Diabetes mellitus 55.00 9.91 106 245665 66368 64186593
Cardiac arrest 54.42 9.91 857 244914 153207 64099754
Palmar-plantar erythrodysaesthesia syndrome 54.40 9.91 236 245535 28583 64224378
Lactic acidosis 54.31 9.91 94 245677 61316 64191645
Bacteraemia 53.60 9.91 224 245547 26687 64226274
Inflammation 53.27 9.91 105 245666 65195 64187766
Interstitial lung disease 52.61 9.91 193 245578 97539 64155422
Psoriasis 52.10 9.91 123 245648 71580 64181381
Impaired gastric emptying 51.83 9.91 108 245663 8696 64244265
Carbohydrate antigen 125 increased 51.33 9.91 49 245722 1879 64251082
Irritable bowel syndrome 50.37 9.91 41 245730 37328 64215633
Oculogyric crisis 50.28 9.91 55 245716 2483 64250478
Knee arthroplasty 50.14 9.91 20 245751 26979 64225982
Pleural effusion 50.13 9.91 718 245053 125841 64127120
Arthritis 49.53 9.91 159 245612 83655 64169306
Oral pain 49.51 9.91 222 245549 27271 64225690
Drug dependence 49.50 9.91 33 245738 33279 64219682
Discomfort 48.80 9.91 152 245619 80726 64172235
Coma 48.50 9.91 171 245600 87444 64165517
Injection site reaction 48.44 9.91 64 245707 46600 64206361
Wrong technique in product usage process 48.38 9.91 110 245661 64864 64188097
Appendicitis 48.22 9.91 137 245634 13432 64239529
Blood pressure fluctuation 48.09 9.91 77 245694 51794 64201167
Hypomagnesaemia 47.75 9.91 274 245497 37102 64215859
Hereditary angioedema 47.58 9.91 66 245705 3810 64249151
Dystonia 47.37 9.91 169 245602 18696 64234265
Blood creatine phosphokinase increased 47.05 9.91 95 245676 58463 64194498
Unresponsive to stimuli 46.90 9.91 341 245430 50052 64202909
Retching 46.60 9.91 146 245625 15110 64237851
Psoriatic arthropathy 46.33 9.91 58 245713 43223 64209738
Desmoplastic small round cell tumour 45.30 9.91 15 245756 57 64252904
Atelectasis 45.28 9.91 215 245556 27051 64225910
Dyspnoea 44.90 9.91 3246 242525 715428 63537533
Neurotoxicity 44.72 9.91 215 245556 27189 64225772
Hair colour changes 43.58 9.91 62 245709 3665 64249296
Blood pressure systolic increased 43.45 9.91 76 245695 49377 64203584
Clostridium difficile colitis 43.29 9.91 212 245559 27011 64225950
Cerebral infarction 42.90 9.91 56 245715 40988 64211973
Pulmonary embolism 42.56 9.91 789 244982 145567 64107394
Back pain 42.47 9.91 1251 244520 248920 64004041
Osteonecrosis of jaw 41.98 9.91 54 245717 39771 64213190
Aggression 41.58 9.91 70 245701 46162 64206799
Mental status changes 41.36 9.91 385 245386 60777 64192184
Folliculitis 40.54 9.91 33 245738 30044 64222917
Therapy non-responder 39.65 9.91 124 245647 65775 64187186
Abdominal discomfort 39.61 9.91 474 245297 181848 64071113
Neutropenic colitis 39.24 9.91 66 245705 4515 64248446
Segmental diverticular colitis 39.06 9.91 16 245755 123 64252838
Device expulsion 38.69 9.91 16 245755 21120 64231841
Injection site bruising 38.67 9.91 49 245722 36324 64216637
Hallucination, auditory 37.82 9.91 9 245762 16930 64236031
Dry skin 37.64 9.91 328 245443 50833 64202128
Sinusitis 37.48 9.91 365 245406 145563 64107398
Melaena 37.22 9.91 94 245677 53454 64199507
Pain in extremity 37.21 9.91 875 244896 302210 63950751
Calcium ionised decreased 37.10 9.91 24 245747 514 64252447
Hip arthroplasty 36.21 9.91 18 245753 21333 64231628
Hypervolaemia 36.16 9.91 260 245511 38025 64214936
Dilatation intrahepatic duct acquired 36.07 9.91 26 245745 668 64252293
Treatment noncompliance 35.39 9.91 70 245701 43412 64209549
Injection site pruritus 35.21 9.91 56 245715 37770 64215191
Hypophagia 35.19 9.91 265 245506 39322 64213639
Cardiac failure congestive 35.07 9.91 323 245448 130257 64122704
C-reactive protein increased 34.89 9.91 215 245556 94694 64158267
Cytomegalovirus infection 34.69 9.91 55 245716 37144 64215817
Gait disturbance 34.61 9.91 455 245316 171700 64081261
Osteonecrosis 34.42 9.91 34 245737 28195 64224766
Basal cell carcinoma 34.42 9.91 40 245731 30798 64222163
Blood pressure diastolic abnormal 34.26 9.91 3 245768 11914 64241047
Lupus vasculitis 34.05 9.91 22 245749 470 64252491
Labelled drug-drug interaction medication error 33.95 9.91 21 245750 22041 64230920
Pancreatitis 33.90 9.91 362 245409 59245 64193716
Hypoglycaemia 33.90 9.91 202 245569 89690 64163271
Laryngeal discomfort 33.77 9.91 22 245749 477 64252484
Poisoning 33.42 9.91 21 245750 21858 64231103
Sense of oppression 33.37 9.91 34 245737 1413 64251548
Fibromyalgia 33.16 9.91 53 245718 35678 64217283
Stridor 32.53 9.91 63 245708 4811 64248150
Intestinal obstruction 32.31 9.91 243 245528 36043 64216918
Hot flush 32.25 9.91 293 245478 45942 64207019
Electrocardiogram QT shortened 32.16 9.91 16 245755 202 64252759
Paraesthesia 32.04 9.91 704 245067 133818 64119143
Electrocardiogram QRS complex 32.02 9.91 7 245764 0 64252961
Myalgia 31.97 9.91 419 245352 158198 64094763
Obstructive airways disorder 31.79 9.91 25 245746 23160 64229801
Depressed level of consciousness 31.77 9.91 181 245590 81255 64171706
Liver disorder 31.66 9.91 101 245670 53250 64199711
Anaphylactic shock 31.61 9.91 211 245560 30117 64222844
Schizophrenia 31.60 9.91 3 245768 11165 64241796
Heart rate decreased 31.47 9.91 106 245665 54961 64198000
International normalised ratio increased 31.40 9.91 175 245596 78992 64173969
Taste disorder 31.36 9.91 93 245678 9340 64243621
Hyperkalaemia 31.28 9.91 241 245530 100888 64152073
Computerised tomogram thorax abnormal 31.15 9.91 38 245733 1931 64251030
Abortion spontaneous 30.98 9.91 30 245741 25113 64227848
Lower respiratory tract infection 30.92 9.91 222 245549 94392 64158569
Disease recurrence 30.92 9.91 45 245726 31465 64221496
Pemphigoid 30.83 9.91 6 245765 12980 64239981
Accidental exposure to product 30.73 9.91 33 245738 26331 64226630
Ageusia 30.72 9.91 119 245652 13694 64239267
Pedal pulse abnormal 30.57 9.91 14 245757 145 64252816
Joint range of motion decreased 30.34 9.91 18 245753 19325 64233636
Pharyngeal paraesthesia 30.34 9.91 37 245734 1880 64251081
Pneumonitis 30.12 9.91 309 245462 50056 64202905
Fracture 30.06 9.91 17 245754 18738 64234223
Immune-mediated hepatitis 29.98 9.91 42 245729 2447 64250514
Tumour lysis syndrome 29.92 9.91 150 245621 19290 64233671
Injection site haemorrhage 29.88 9.91 29 245742 24249 64228712
Drug interaction 29.75 9.91 1104 244667 360979 63891982
Oral candidiasis 29.54 9.91 170 245601 23042 64229919
Pain 29.27 9.91 1769 244002 551742 63701219
Tendonitis 28.93 9.91 21 245750 20261 64232700
Drug eruption 28.71 9.91 59 245712 36077 64216884
Negative pressure pulmonary oedema 28.66 9.91 15 245756 212 64252749
Hyperhidrosis 28.57 9.91 650 245121 124270 64128691
Enteritis 28.47 9.91 106 245665 11971 64240990
Cardiac failure 28.41 9.91 345 245426 132028 64120933
Transmission of an infectious agent via product 28.33 9.91 14 245757 174 64252787
Product use issue 28.33 9.91 407 245364 151308 64101653
Hepatocellular injury 28.24 9.91 280 245491 44955 64208006
Vasculitis 28.15 9.91 17 245754 18078 64234883
Disability 28.11 9.91 6 245765 12166 64240795
Arteriosclerosis coronary artery 28.03 9.91 12 245759 15517 64237444
Left atrial hypertrophy 28.01 9.91 10 245761 50 64252911
Opisthotonus 27.91 9.91 22 245749 649 64252312
Burkholderia cepacia complex infection 27.72 9.91 16 245755 277 64252684
Apnoea 27.58 9.91 95 245676 10327 64242634
Deep vein thrombosis 27.49 9.91 558 245213 104624 64148337
Paranoia 27.41 9.91 14 245757 16338 64236623
Glaucoma 27.40 9.91 14 245757 16334 64236627
Type I hypersensitivity 27.36 9.91 49 245722 3525 64249436
Bone density decreased 27.31 9.91 3 245768 9949 64243012
Oxygen saturation immeasurable 27.22 9.91 9 245762 34 64252927
Sedation 27.13 9.91 75 245696 41387 64211574
Epistaxis 27.13 9.91 525 245246 97606 64155355
Skin ulcer 26.98 9.91 82 245689 43892 64209069
Stomatitis 26.87 9.91 576 245195 109029 64143932
Altered state of consciousness 26.75 9.91 66 245705 37836 64215125
Sinus tachycardia 26.68 9.91 212 245559 31976 64220985
Acute myocardial infarction 26.64 9.91 156 245615 69562 64183399
Bronchospasm 26.43 9.91 157 245614 21525 64231436
Sedation complication 26.30 9.91 4 245767 10350 64242611
Product substitution issue 26.12 9.91 18 245753 17843 64235118
Contusion 26.01 9.91 293 245478 113672 64139289
Acute respiratory failure 25.99 9.91 298 245473 49636 64203325
Cestode infection 25.82 9.91 15 245756 263 64252698
Hyponatraemia 25.75 9.91 744 245027 147595 64105366
Toxic erythema of chemotherapy 25.56 9.91 14 245757 218 64252743
Platelet transfusion 25.54 9.91 33 245738 1778 64251183
Drug clearance decreased 25.52 9.91 40 245731 2579 64250382
Septic shock 25.17 9.91 552 245219 104885 64148076
Substance abuse 25.00 9.91 3 245768 9289 64243672
Pulse absent 24.95 9.91 83 245688 8863 64244098
Blood pressure systolic abnormal 24.89 9.91 4 245767 9938 64243023
Transplant rejection 24.84 9.91 18 245753 17383 64235578
Gastrointestinal haemorrhage 24.68 9.91 355 245416 131957 64121004
Coronary artery occlusion 24.65 9.91 11 245760 13880 64239081
Venoocclusive liver disease 24.53 9.91 89 245682 9926 64243035
Immune effector cell-associated neurotoxicity syndrome 24.41 9.91 39 245732 2556 64250405
Hyperlipidaemia 24.37 9.91 31 245740 22945 64230016
Therapy interrupted 24.37 9.91 145 245626 19891 64233070
Suicidal ideation 24.31 9.91 151 245620 66391 64186570
Malnutrition 24.29 9.91 140 245631 18985 64233976
Bone erosion 24.29 9.91 7 245764 11588 64241373
Oropharyngeal discomfort 24.20 9.91 59 245712 5276 64247685
Malignant catatonia 24.00 9.91 16 245755 361 64252600
Glycosylated haemoglobin increased 23.62 9.91 16 245755 16003 64236958
Respiratory distress 23.62 9.91 304 245467 52027 64200934
Premature delivery 23.56 9.91 136 245635 18453 64234508
Ileus 23.47 9.91 159 245612 22807 64230154
Tryptase increased 23.31 9.91 17 245754 445 64252516
Blood pressure measurement 23.29 9.91 16 245755 380 64252581
Amputation stump pain 23.27 9.91 8 245763 35 64252926
Vascular access site thrombosis 23.27 9.91 8 245763 35 64252926
Chest discomfort 23.18 9.91 593 245178 115513 64137448
Hypercholesterolaemia 23.15 9.91 15 245756 15358 64237603
Dementia 23.10 9.91 27 245744 20739 64232222
Anaesthetic complication neurological 22.95 9.91 18 245753 527 64252434
Rash maculo-papular 22.86 9.91 277 245494 46749 64206212
Bursitis 22.78 9.91 29 245742 21456 64231505
Hospitalisation 22.74 9.91 408 245363 74799 64178162
Electrocardiogram T wave biphasic 22.72 9.91 12 245759 173 64252788
Haematoma 22.54 9.91 95 245676 46155 64206806
Dyslipidaemia 22.52 9.91 4 245767 9238 64243723
Cervix neoplasm 22.42 9.91 12 245759 178 64252783
Erectile dysfunction 22.41 9.91 10 245761 12617 64240344
Blood potassium decreased 22.35 9.91 244 245527 40155 64212806
Psychotic disorder 22.29 9.91 63 245708 34515 64218446
Toxic encephalopathy 22.19 9.91 85 245686 9730 64243231
Muscle twitching 22.16 9.91 136 245635 18862 64234099
Blood magnesium decreased 21.90 9.91 108 245663 13797 64239164
Hyperaemia 21.85 9.91 38 245733 2671 64250290
Intentional product use issue 21.83 9.91 245 245526 95119 64157842
Bone disorder 21.83 9.91 19 245752 16740 64236221
Infective pulmonary exacerbation of cystic fibrosis 21.80 9.91 96 245675 11700 64241261
Periorbital cellulitis 21.64 9.91 20 245751 736 64252225
Embolism 21.43 9.91 98 245673 12137 64240824
Femur fracture 21.41 9.91 63 245708 34072 64218889
Cerebrovascular accident 21.37 9.91 382 245389 137201 64115760
Peripheral sensory neuropathy 21.34 9.91 93 245678 11285 64241676
Herpes zoster 21.20 9.91 196 245575 78991 64173970
Inappropriate schedule of product administration 21.16 9.91 237 245534 92049 64160912
Anaphylactoid reaction 21.07 9.91 52 245719 4686 64248275
Administration site oedema 21.06 9.91 7 245764 27 64252934
Red blood cell count decreased 20.97 9.91 279 245492 48107 64204854
Somnolence 20.96 9.91 603 245168 203042 64049919
Streptococcal bacteraemia 20.91 9.91 40 245731 3027 64249934
Bone pain 20.90 9.91 275 245496 47297 64205664
Rotator cuff syndrome 20.85 9.91 10 245761 12097 64240864
Palmar erythema 20.82 9.91 29 245742 1681 64251280
Cytopenia 20.80 9.91 115 245656 15356 64237605
Respiratory syncytial virus infection 20.78 9.91 68 245703 7200 64245761
Pathogen resistance 20.64 9.91 11 245760 12532 64240429
Large intestinal obstruction 20.63 9.91 37 245734 2665 64250296
Granulocytopenia 20.62 9.91 7 245764 10433 64242528
Haemorrhage 20.56 9.91 198 245573 79153 64173808
Carpal tunnel syndrome 20.55 9.91 18 245753 15810 64237151
Obesity 20.53 9.91 29 245742 20533 64232428
Hyperthermia 20.52 9.91 115 245656 15435 64237526
Blood triglycerides increased 20.49 9.91 25 245746 18841 64234120
Depression 20.34 9.91 537 245234 182754 64070207
Alopecia areata 20.25 9.91 27 245744 1501 64251460
Testicular germ cell cancer metastatic 20.05 9.91 8 245763 57 64252904
Foot deformity 19.98 9.91 20 245751 16484 64236477
Wheezing 19.66 9.91 204 245567 80375 64172586
Myopathy 19.66 9.91 23 245748 17657 64235304
Procedural vomiting 19.62 9.91 18 245753 656 64252305
Hypophosphataemia 19.51 9.91 109 245662 14611 64238350
Diabetes mellitus inadequate control 19.43 9.91 32 245739 21289 64231672
Cerebral microhaemorrhage 19.39 9.91 11 245760 184 64252777
Device related infection 19.32 9.91 190 245581 30436 64222525
Panniculitis 19.28 9.91 5 245766 8874 64244087
Post procedural hypotension 19.26 9.91 8 245763 64 64252897
Orthostatic hypotension 19.26 9.91 102 245669 46636 64206325
Arteriospasm coronary 19.24 9.91 55 245716 5410 64247551
Chest pain 19.22 9.91 1091 244680 234889 64018072
Sleep disorder due to a general medical condition 19.14 9.91 4 245767 8230 64244731
Poisoning deliberate 19.11 9.91 14 245757 13444 64239517
Cognitive disorder 19.11 9.91 127 245644 54960 64198001
Lupus-like syndrome 18.99 9.91 5 245766 8786 64244175
Migraine 18.94 9.91 340 245431 62337 64190624
Vein discolouration 18.91 9.91 13 245758 309 64252652
Capillary leak syndrome 18.89 9.91 40 245731 3257 64249704
Computerised tomogram thorax 18.82 9.91 10 245761 146 64252815
Cerebral haemorrhage 18.63 9.91 116 245655 50974 64201987
Chronic obstructive pulmonary disease 18.53 9.91 177 245594 70871 64182090
Pseudomonal bacteraemia 18.52 9.91 32 245739 2237 64250724
Shock haemorrhagic 18.50 9.91 22 245749 16769 64236192
Stress cardiomyopathy 18.39 9.91 77 245694 9180 64243781
Insomnia 18.34 9.91 594 245177 197242 64055719
Magnesium deficiency 18.30 9.91 16 245755 547 64252414
Pulmonary fibrosis 18.12 9.91 56 245715 29822 64223139
Blood bilirubin increased 18.03 9.91 314 245457 57239 64195722
Hypothyroidism 17.98 9.91 86 245685 40371 64212590
Glioblastoma multiforme 17.97 9.91 22 245749 1122 64251839
Medication error 17.94 9.91 114 245657 49852 64203109
Madarosis 17.91 9.91 32 245739 2298 64250663
Long QT syndrome congenital 17.89 9.91 7 245764 47 64252914
Respiratory failure 17.88 9.91 768 245003 160415 64092546
Chemotherapeutic drug level increased 17.87 9.91 13 245758 339 64252622
Injection site warmth 17.86 9.91 15 245756 13447 64239514
Klebsiella bacteraemia 17.81 9.91 32 245739 2308 64250653
Neutropenic infection 17.76 9.91 29 245742 1936 64251025
Oedema peripheral 17.75 9.91 639 245132 209678 64043283
Body temperature decreased 17.64 9.91 46 245725 25882 64227079
IIIrd nerve paresis 17.64 9.91 10 245761 167 64252794
Plantar erythema 17.54 9.91 12 245759 283 64252678
Nail pigmentation 17.29 9.91 12 245759 290 64252671
Premenstrual syndrome 17.25 9.91 15 245756 509 64252452
Osteomyelitis 17.24 9.91 51 245720 27536 64225425
Infusion site streaking 17.20 9.91 14 245757 433 64252528
Therapeutic product effect prolonged 17.17 9.91 15 245756 512 64252449
Nasal congestion 17.14 9.91 145 245626 59513 64193448
Eczema 17.12 9.91 57 245714 29663 64223298
Metastases to meninges 17.12 9.91 35 245736 2780 64250181
Large intestine polyp 17.12 9.91 10 245761 10827 64242134
Abdominal distension 17.07 9.91 483 245288 95511 64157450
Lip pruritus 17.05 9.91 17 245754 688 64252273
Joint stiffness 17.05 9.91 59 245712 30345 64222616
Supraventricular tachycardia 17.05 9.91 127 245644 18780 64234181
Aphasia 16.96 9.91 234 245537 40672 64212289
Coronary artery stenosis 16.90 9.91 11 245760 11237 64241724
Epilepsy 16.89 9.91 68 245703 33463 64219498
Transfusion 16.87 9.91 122 245649 17872 64235089
Prostate cancer 16.87 9.91 31 245740 19764 64233197
Vascular access site infection 16.81 9.91 8 245763 91 64252870
Incorrect dose administered 16.44 9.91 150 245621 60615 64192346
Immune reconstitution inflammatory syndrome 16.41 9.91 14 245757 12456 64240505
Uterine perforation 16.24 9.91 54 245717 5766 64247195
Peripheral swelling 16.20 9.91 642 245129 208511 64044450
Feeding intolerance 16.11 9.91 15 245756 557 64252404
Eosinophil count increased 16.08 9.91 18 245753 14094 64238867
Hypergeusia 16.00 9.91 5 245766 15 64252946
Blood glucose increased 15.97 9.91 270 245501 97803 64155158
Sleep disorder 15.89 9.91 148 245623 59561 64193400
Uveitis 15.85 9.91 15 245756 12693 64240268
Atrial fibrillation 15.71 9.91 800 244971 170289 64082672
Malaise 15.69 9.91 1732 244039 394515 63858446
Congenital anomaly in offspring 15.68 9.91 7 245764 68 64252893
Visual acuity reduced 15.67 9.91 52 245719 27089 64225872
Hyperbilirubinaemia 15.62 9.91 136 245635 21069 64231892
Hyperthermia malignant 15.46 9.91 31 245740 2428 64250533
Procedural nausea 15.45 9.91 16 245755 678 64252283
Enterocolitis infectious 15.42 9.91 31 245740 2433 64250528
Anorectal disorder 15.38 9.91 27 245744 1912 64251049
Tubulointerstitial nephritis 15.37 9.91 63 245708 30846 64222115
Delirium 15.35 9.91 179 245592 69015 64183946
Onychalgia 15.32 9.91 17 245754 780 64252181
Neutrophil count abnormal 15.30 9.91 34 245737 2862 64250099
Angina unstable 15.26 9.91 22 245749 15445 64237516
Angina pectoris 15.10 9.91 105 245666 44976 64207985
Uterine hypotonus 14.92 9.91 7 245764 77 64252884
Nephrotic syndrome 14.87 9.91 9 245762 9558 64243403
Musculoskeletal pain 14.85 9.91 219 245552 81075 64171886
Posterior reversible encephalopathy syndrome 14.79 9.91 143 245628 22803 64230158
Troponin increased 14.78 9.91 105 245666 15294 64237667
Alopecia totalis 14.66 9.91 11 245760 301 64252660
Myoclonus 14.49 9.91 153 245618 24965 64227996
Joint effusion 14.48 9.91 18 245753 13455 64239506
Tuberculosis 14.45 9.91 17 245754 13021 64239940
Abdominal mass 14.38 9.91 34 245737 2981 64249980
Subchorionic haemorrhage 14.36 9.91 8 245763 129 64252832
Haemodialysis 14.32 9.91 27 245744 17050 64235911
Eye irritation 14.26 9.91 24 245747 15832 64237129
Lipase decreased 14.25 9.91 8 245763 131 64252830
Extravasation 14.24 9.91 35 245736 3145 64249816
Seminoma 14.19 9.91 9 245762 186 64252775
Sensitivity to weather change 14.16 9.91 4 245767 6710 64246251
Perihepatic abscess 14.09 9.91 8 245763 134 64252827
Chronic hepatitis B 14.04 9.91 10 245761 252 64252709
Ulcer 14.01 9.91 43 245728 22947 64230014
Enterocolitis 13.99 9.91 86 245685 11932 64241029
Joint injury 13.92 9.91 43 245728 22904 64230057
Shock 13.85 9.91 87 245684 38153 64214808
Joint dislocation 13.76 9.91 14 245757 11451 64241510
Head and neck cancer metastatic 13.72 9.91 3 245768 0 64252961
Foetal damage 13.72 9.91 3 245768 0 64252961
Electrocardiogram PR shortened 13.70 9.91 10 245761 262 64252699
Myocardial reperfusion injury 13.69 9.91 5 245766 27 64252934
Exostosis 13.69 9.91 14 245757 11424 64241537
Irritability 13.62 9.91 83 245688 36663 64216298
Formication 13.59 9.91 42 245729 4315 64248646
Abnormal behaviour 13.51 9.91 74 245697 33548 64219413
Polymenorrhoea 13.49 9.91 17 245754 893 64252068
Acute myeloid leukaemia 13.45 9.91 162 245609 27301 64225660
Gastroenteropancreatic neuroendocrine tumour disease 13.40 9.91 5 245766 29 64252932
Hair texture abnormal 13.39 9.91 33 245738 2971 64249990
Blood pressure diastolic decreased 13.38 9.91 42 245729 22259 64230702
Tracheal injury 13.37 9.91 6 245765 59 64252902
Sialoadenitis 13.29 9.91 23 245748 1610 64251351
Drug abuser 13.14 9.91 3 245768 5805 64247156
Anger 13.11 9.91 25 245746 15716 64237245
Postural orthostatic tachycardia syndrome 13.10 9.91 13 245758 523 64252438
Seizure like phenomena 13.10 9.91 23 245748 1629 64251332
Device malfunction 13.00 9.91 30 245741 17603 64235358
Cerebellar stroke 13.00 9.91 12 245759 441 64252520
Intestinal infarction 12.97 9.91 20 245751 1271 64251690
Necrotising retinitis 12.90 9.91 18 245753 1045 64251916
Pulseless electrical activity 12.90 9.91 88 245683 12651 64240310
Cyclic vomiting syndrome 12.87 9.91 6 245765 65 64252896
Skin cancer 12.86 9.91 16 245755 11958 64241003
Painful respiration 12.85 9.91 33 245738 3048 64249913
Creatinine renal clearance decreased 12.81 9.91 22 245749 14399 64238562
Infection 12.74 9.91 575 245196 184305 64068656
Pregnancy 12.73 9.91 39 245732 20826 64232135
Pharyngeal hypoaesthesia 12.69 9.91 10 245761 295 64252666
Ill-defined disorder 12.69 9.91 107 245664 43945 64209016
Coating in mouth 12.66 9.91 9 245762 226 64252735
Skin necrosis 12.61 9.91 22 245749 14307 64238654
Blood alkaline phosphatase increased 12.60 9.91 292 245479 55987 64196974
Urinary tract infection 12.53 9.91 1035 244736 230561 64022400
Drug reaction with eosinophilia and systemic symptoms 12.52 9.91 139 245632 54078 64198883
Unintentional medical device removal 12.48 9.91 5 245766 6729 64246232
Gastroenteritis radiation 12.45 9.91 14 245757 652 64252309
Electrocardiogram T wave inversion 12.42 9.91 44 245727 4850 64248111
Benign prostatic hyperplasia 12.42 9.91 10 245761 9155 64243806
Disseminated aspergillosis 12.41 9.91 14 245757 654 64252307
Throat tightness 12.40 9.91 139 245632 23021 64229940
Erythropenia 12.38 9.91 11 245760 384 64252577
Sleep apnoea syndrome 12.35 9.91 65 245706 29767 64223194
Suspected suicide 12.29 9.91 9 245762 8645 64244316
Sciatica 12.28 9.91 38 245733 20226 64232735
Feeding disorder 12.26 9.91 88 245683 12861 64240100
Wrist fracture 12.24 9.91 12 245759 9989 64242972
Breast cancer metastatic 12.24 9.91 57 245714 7112 64245849
Intestinal perforation 12.23 9.91 100 245671 15213 64237748
Cytotoxic oedema 12.21 9.91 10 245761 312 64252649
Lymphoid tissue hypoplasia 12.17 9.91 12 245759 479 64252482
Medical device site fistula 12.14 9.91 5 245766 39 64252922
Kidney transplant rejection 12.13 9.91 11 245760 9500 64243461
Tongue disorder 12.10 9.91 17 245754 12063 64240898
Moaning 12.03 9.91 17 245754 999 64251962
Non-cardiac chest pain 11.99 9.91 65 245706 8615 64244346
Abdominal pain upper 11.96 9.91 797 244974 174233 64078728
Blood pressure diastolic increased 11.94 9.91 14 245757 10738 64242223
Skin burning sensation 11.87 9.91 75 245696 10508 64242453
Dysphagia 11.85 9.91 509 245262 106303 64146658
Tachypnoea 11.84 9.91 154 245617 26417 64226544
Incarcerated umbilical hernia 11.83 9.91 5 245766 42 64252919
Metastases to peritoneum 11.82 9.91 35 245736 3512 64249449
Ventricular hypertrophy 11.82 9.91 5 245766 6511 64246450
Platelet count increased 11.80 9.91 116 245655 18580 64234381
Laryngeal dyspnoea 11.76 9.91 9 245762 254 64252707
Abdominal infection 11.76 9.91 31 245740 2909 64250052
Periorbital disorder 11.63 9.91 5 245766 44 64252917
Dysphemia 11.58 9.91 32 245739 3087 64249874
Blister 11.58 9.91 228 245543 80739 64172222
Escherichia bacteraemia 11.57 9.91 46 245725 5357 64247604
Appendicitis perforated 11.55 9.91 30 245741 2790 64250171
Food intolerance 11.51 9.91 30 245741 2796 64250165
Parainfluenzae virus infection 11.49 9.91 42 245729 4701 64248260
Coeliac disease 11.48 9.91 7 245764 7405 64245556
Muscle spasms 11.47 9.91 652 245119 140371 64112590
Electrocardiogram QRS complex prolonged 11.42 9.91 11 245760 9233 64243728
Respiratory rate increased 11.37 9.91 34 245737 18297 64234664
Thymus hypoplasia 11.35 9.91 12 245759 521 64252440
Gait inability 11.28 9.91 105 245666 42263 64210698
Acute kidney injury 11.24 9.91 1911 243860 447329 63805632
Cataract 11.22 9.91 133 245638 51129 64201832
Sinus node dysfunction 11.22 9.91 6 245765 6822 64246139
Influenza B virus test positive 11.21 9.91 10 245761 351 64252610
Electrocardiogram ST segment elevation 11.16 9.91 56 245715 7203 64245758
Ankylosing spondylitis 11.14 9.91 9 245762 8225 64244736
Chest injury 11.13 9.91 27 245744 2406 64250555
Asphyxia 11.12 9.91 12 245759 9554 64243407
Muscle haemorrhage 11.12 9.91 4 245767 5749 64247212
Intensive care 11.11 9.91 13 245758 632 64252329
Chronic graft versus host disease 11.09 9.91 5 245766 6271 64246690
Lung opacity 11.08 9.91 32 245739 3167 64249794
Low density lipoprotein increased 11.06 9.91 8 245763 7732 64245229
Choking sensation 10.95 9.91 34 245737 3501 64249460
Arteriosclerosis 10.93 9.91 28 245743 15849 64237112
Antipsychotic drug level increased 10.88 9.91 3 245768 5112 64247849
Abdominal pain lower 10.80 9.91 151 245620 26318 64226643
Catatonia 10.72 9.91 8 245763 7612 64245349
Trismus 10.72 9.91 42 245729 4859 64248102
Squamous cell carcinoma 10.72 9.91 23 245748 13846 64239115
Large intestine anastomosis 10.70 9.91 6 245765 98 64252863
Blood urea increased 10.68 9.91 112 245659 44041 64208920
Respiratory arrest 10.65 9.91 140 245631 52845 64200116
Left ventricular dysfunction 10.61 9.91 105 245666 16849 64236112
Lichen sclerosus 10.60 9.91 15 245756 882 64252079
Hyperemesis gravidarum 10.57 9.91 10 245761 379 64252582
Cancer pain 10.57 9.91 38 245733 4219 64248742
Thrombosis 10.57 9.91 348 245423 70294 64182667
Tumour pain 10.56 9.91 23 245748 1910 64251051
Cyanosis 10.55 9.91 130 245641 22025 64230936
Neuralgia 10.53 9.91 149 245622 26035 64226926
Transaminases increased 10.49 9.91 233 245538 44361 64208600
Vascular device infection 10.46 9.91 49 245722 6131 64246830
Cleft palate 10.45 9.91 3 245768 6 64252955
Multiple fractures 10.38 9.91 5 245766 6035 64246926
Subileus 10.36 9.91 42 245729 4935 64248026
Carotid artery stenosis 10.35 9.91 9 245762 7932 64245029
Muscle rigidity 10.35 9.91 107 245664 17366 64235595
Neutrophil percentage abnormal 10.34 9.91 4 245767 26 64252935
Menstruation delayed 10.33 9.91 17 245754 1142 64251819
Aortic arteriosclerosis 10.33 9.91 8 245763 7468 64245493
Eye haemorrhage 10.27 9.91 10 245761 8350 64244611
Enterovirus test positive 10.27 9.91 8 245763 232 64252729
Enterocutaneous fistula 10.24 9.91 20 245751 1537 64251424
Scratch 10.23 9.91 6 245765 6483 64246478
Drug ineffective for unapproved indication 10.19 9.91 73 245698 31060 64221901
Gastrooesophageal reflux disease 10.18 9.91 240 245531 82903 64170058
Sexual dysfunction 10.18 9.91 6 245765 6465 64246496
Tardive dyskinesia 10.14 9.91 12 245759 9166 64243795
Cholecystitis 10.13 9.91 117 245654 19519 64233442
Intraocular pressure increased 10.12 9.91 10 245761 8292 64244669
Nail infection 10.11 9.91 22 245749 1825 64251136
Road traffic accident 10.11 9.91 72 245699 30673 64222288
Hydronephrosis 10.10 9.91 90 245681 14035 64238926
Vitamin B1 decreased 10.09 9.91 9 245762 316 64252645
Incorrect route of product administration 10.08 9.91 50 245721 23248 64229713
Alveolitis 10.07 9.91 34 245737 3658 64249303
Dental caries 10.04 9.91 16 245755 10784 64242177
Vocal cord paralysis 10.02 9.91 24 245747 2122 64250839
Corneal bleeding 9.97 9.91 4 245767 29 64252932
Weight decreased 9.96 9.91 1239 244532 284500 63968461
Mucormycosis 9.96 9.91 8 245763 7333 64245628
Product administration error 9.96 9.91 63 245708 27580 64225381
Systemic inflammatory response syndrome 9.95 9.91 70 245701 10165 64242796
Fixed eruption 9.92 9.91 24 245747 2135 64250826

FDA Adverse Event Reporting System (Pediatric)

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
Human herpesvirus 6 infection 47.76 30.08 15 320 45 84298
Cardiac failure 45.07 30.08 15 320 57 84286
Congestive cardiomyopathy 41.29 30.08 14 321 57 84286
Multiple organ dysfunction syndrome 38.34 30.08 15 320 99 84244

Pharmacologic Action:

SourceCodeDescription
ATC A04AA01 ALIMENTARY TRACT AND METABOLISM
ANTIEMETICS AND ANTINAUSEANTS
ANTIEMETICS AND ANTINAUSEANTS
Serotonin (5HT3) antagonists
FDA MoA N0000175817 Serotonin 3 Receptor Antagonists
FDA EPC N0000175818 Serotonin-3 Receptor Antagonist
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000932 Antiemetics
MeSH PA D000982 Antipruritics
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D003879 Dermatologic Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014149 Tranquilizing Agents

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

DiseaseRelationSNOMED_IDDOID
Chemotherapy-induced nausea and vomiting indication 236084000
Prevention of Radiation-Induced Nausea and Vomiting indication
Prevention of Post-Operative Nausea and Vomiting indication
Excessive vomiting in pregnancy off-label use 14094001
Torsades de pointes contraindication 31722008
Hepatic failure contraindication 59927004
Extrapyramidal disease contraindication 76349003
Prolonged QT interval contraindication 111975006
Seizure disorder contraindication 128613002
Congenital long QT syndrome contraindication 442917000




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 7.13 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
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 7.80 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2B GPCR Ki 6.34 DRUG MATRIX
Aldehyde oxidase Enzyme IC50 5.68 WOMBAT-PK
Solute carrier family 22 member 1 Transporter IC50 4.69 CHEMBL
Solute carrier family 22 member 2 Transporter IC50 5.77 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 7.52 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 6.80 CHEMBL
Solute carrier family 22 member 3 Transporter IC50 4.76 CHEMBL
Neuronal acetylcholine receptor; alpha4/beta2 Ion channel Ki 4.34 CHEMBL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.09 WOMBAT-PK
5-hydroxytryptamine receptor 3B Ion channel Ki 8.30 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 5.43 CHEMBL
Mu-type opioid receptor GPCR Ki 5.54 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 5 CHEMBL
Gastrin/cholecystokinin type B receptor GPCR Ki 6.17 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 6.17 CHEMBL
Neuronal acetylcholine receptor subunit alpha-7 Ion channel IC50 4.60 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 5.30 CHEMBL
5-hydroxytryptamine receptor 4 GPCR Ki 5.92 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 9.11 CHEMBL
5-hydroxytryptamine receptor 1D GPCR Ki 4.70 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel Ki 9.11 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 5 CHEMBL
Serotonin 3 receptor (5HT3) Ion channel Ki 7.92 CHEMBL

External reference:

IDSource
4019865 VUID
N0000147951 NUI
D00456 KEGG_DRUG
103639-04-9 SECONDARY_CAS_RN
4019563 VANDF
4019865 VANDF
C0061851 UMLSCUI
CHEBI:7773 CHEBI
S87 PDB_CHEM_ID
CHEMBL46 ChEMBL_ID
CHEMBL399705 ChEMBL_ID
CHEMBL428411 ChEMBL_ID
CHEMBL3186492 ChEMBL_ID
CHEMBL1201111 ChEMBL_ID
DB00904 DRUGBANK_ID
D017294 MESH_DESCRIPTOR_UI
4595 PUBCHEM_CID
2290 IUPHAR_LIGAND_ID
5965 INN_ID
4AF302ESOS UNII
203148 RXNORM
27290 MMSL
39615 MMSL
5202 MMSL
90631 MMSL
d00867 MMSL
003568 NDDF
004807 NDDF
108418007 SNOMEDCT_US
108419004 SNOMEDCT_US
372487007 SNOMEDCT_US
830157000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0054-0064 SOLUTION 4 mg ORAL ANDA 27 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0675 TABLET, FILM COATED 4 mg ORAL NDA 31 sections
ZOFRAN HUMAN PRESCRIPTION DRUG LABEL 1 0078-0676 TABLET, FILM COATED 8 mg ORAL NDA 31 sections
Ondansetron Hydrochloride and Dextrose HUMAN PRESCRIPTION DRUG LABEL 1 0143-9771 INJECTION, SOLUTION 32 mg INTRAVENOUS ANDA 24 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9890 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0143-9891 INJECTION 2 mg INTRAMUSCULAR ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7732 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 28 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0378-7734 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 28 sections
ONDANSETRON HUMAN PRESCRIPTION DRUG LABEL 1 0404-9930 INJECTION 2 mg INTRAVENOUS ANDA 18 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4755 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 32 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0409-4759 INJECTION, SOLUTION 2 mg INTRAMUSCULAR ANDA 32 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0527-1726 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8185 TABLET, FILM COATED 4 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6078 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6079 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0641-6080 INJECTION 2 mg INTRAMUSCULAR ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6551 TABLET, FILM COATED 4 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 27 sections
ondansetron hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6552 TABLET, FILM COATED 8 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0904-7073 SOLUTION 4 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 0904-7073 SOLUTION 4 mg ORAL ANDA 27 sections
Ondansetron Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-575 TABLET, FILM COATED 8 mg ORAL ANDA 22 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-365 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 26 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 11819-371 TABLET, ORALLY DISINTEGRATING 8 mg ORAL ANDA 27 sections
Ondansetron HUMAN PRESCRIPTION DRUG LABEL 1 16590-545 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 12 sections
Ondansetron Human Prescription Drug Label 1 16714-159 TABLET, FILM COATED 4 mg ORAL ANDA 27 sections