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

Stem definitionDrug idCAS RN
962 469-21-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • doxylamine
  • (+/-)-Doxylamine
  • doxylamine succinate
Histamine H1 antagonist with pronounced sedative properties. It is used in allergies and as an antitussive, antiemetic, and hypnotic. Doxylamine has also been administered in veterinary applications and was formerly used in PARKINSONISM.
  • Molecular weight: 270.38
  • Formula: C17H22N2O
  • CLOGP: 2.35
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 25.36
  • ALOGS: -2.70
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
25 mg O

ADMET properties:

PropertyValueReference
BA (Bioavailability) 24.70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
April 7, 1948 FDA SANOFI AVENTIS US

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
Completed suicide 2535.46 9.85 3616 316269 128273 50156966
Toxicity to various agents 2113.18 9.85 4345 315540 208154 50077085
Infusion related reaction 890.12 9.85 2721 317164 166836 50118403
Sinusitis 670.48 9.85 2484 317401 168074 50117165
Muscle injury 576.66 9.85 923 318962 36188 50249051
Folliculitis 569.42 9.85 946 318939 38279 50246960
Exposure to toxic agent 544.06 9.85 320 319565 3338 50281901
Acute hepatic failure 505.79 9.85 558 319327 15119 50270120
Lower respiratory tract infection 490.56 9.85 1519 318366 93682 50191557
Irritable bowel syndrome 489.29 9.85 1035 318850 50406 50234833
Overdose 424.09 9.85 1491 318394 98236 50187003
Blister 380.46 9.85 1297 318588 84121 50201118
Sleep disorder due to general medical condition, insomnia type 380.38 9.85 700 319185 30747 50254492
Ill-defined disorder 379.55 9.85 972 318913 53682 50231557
Blood pressure fluctuation 357.22 9.85 735 319150 35088 50250151
Intentional product misuse 344.22 9.85 850 319035 45884 50239355
Metabolic acidosis 338.13 9.85 754 319131 38071 50247168
Impaired healing 318.96 9.85 1069 318816 68717 50216522
Duodenal ulcer perforation 315.45 9.85 810 319075 44801 50240438
Anti-cyclic citrullinated peptide antibody positive 315.32 9.85 1073 318812 69514 50215725
Joint swelling 310.98 9.85 2628 317257 242658 50042581
Product dose omission issue 309.42 9.85 426 319459 183412 50101827
Helicobacter infection 308.62 9.85 848 319037 48854 50236385
Pericarditis 294.45 9.85 1129 318756 77560 50207679
Hepatic enzyme increased 280.39 9.85 1653 318232 135727 50149512
Injection site pain 274.59 9.85 182 319703 110842 50174397
Rheumatoid arthritis 265.55 9.85 2187 317698 200363 50084876
Nasopharyngitis 258.77 9.85 2094 317791 190833 50094406
Therapeutic product effect decreased 251.70 9.85 1596 318289 134454 50150785
Gastrointestinal disorder 226.95 9.85 1188 318697 93268 50191971
Hepatotoxicity 217.40 9.85 511 319374 26715 50258524
Stomatitis 205.75 9.85 1218 318667 100126 50185113
Anion gap 202.78 9.85 112 319773 1025 50284214
Diarrhoea 198.64 9.85 2578 317307 585898 49699341
Intentional overdose 195.07 9.85 848 319037 61656 50223583
Synovitis 190.20 9.85 1388 318497 122477 50162762
Body temperature increased 188.84 9.85 529 319356 30812 50254427
Intentional product use issue 188.59 9.85 973 318912 75945 50209294
Hypersensitivity 187.84 9.85 2133 317752 213028 50072211
Hand deformity 183.08 9.85 1172 318713 99027 50186212
Swelling 181.07 9.85 2004 317881 198868 50086371
Weight increased 178.27 9.85 2006 317879 199885 50085354
Discomfort 163.80 9.85 1210 318675 107170 50178069
Peripheral swelling 157.52 9.85 1991 317894 203945 50081294
Wound 155.84 9.85 1174 318711 104620 50180619
Medication error 152.59 9.85 539 319346 35565 50249674
Injection site erythema 152.52 9.85 149 319736 74787 50210452
Device expulsion 149.23 9.85 8 319877 28814 50256425
Depressed level of consciousness 147.20 9.85 685 319200 51268 50233971
Psoriasis 142.99 9.85 135 319750 68865 50216374
Wrong technique in product usage process 142.67 9.85 87 319798 55423 50229816
Coagulopathy 135.92 9.85 330 319555 17614 50267625
Sedation complication 134.68 9.85 217 319668 8549 50276690
Respiratory arrest 134.63 9.85 457 319428 29552 50255687
Hepatic cytolysis 133.35 9.85 207 319678 7896 50277343
Ear pain 129.79 9.85 434 319451 27849 50257390
Heart rate decreased 129.39 9.85 515 319370 35982 50249257
Injection site reaction 122.32 9.85 83 319802 49949 50235290
Infection 116.36 9.85 1634 318251 171320 50113919
Drug hypersensitivity 115.62 9.85 1022 318863 249988 50035251
Creatinine renal clearance decreased 115.14 9.85 241 319644 11640 50273599
Analgesic drug level increased 112.71 9.85 91 319794 1640 50283599
Hepatic failure 111.61 9.85 452 319433 31831 50253408
Blood pressure diastolic abnormal 111.42 9.85 207 319678 9154 50276085
Cardio-respiratory arrest 111.41 9.85 651 319234 53241 50231998
Rheumatoid factor positive 110.78 9.85 614 319271 49245 50235994
Infusion site pain 109.95 9.85 242 319643 12104 50273135
Muscle spasticity 106.42 9.85 293 319592 16891 50268348
Pruritus 104.70 9.85 2437 317448 281131 50004108
Anaemia 104.67 9.85 1055 318830 251401 50033838
Confusional state 103.22 9.85 1700 318185 184228 50101011
Infusion site swelling 99.98 9.85 170 319715 7006 50278233
Injection site bruising 96.77 9.85 56 319829 36712 50248527
Poisoning 93.51 9.85 228 319657 12201 50273038
Injection site pruritus 92.32 9.85 72 319813 40339 50244900
Cardiac failure congestive 91.81 9.85 253 319632 84129 50201110
Blood calcium decreased 91.71 9.85 314 319571 20392 50264847
Hepatic necrosis 90.49 9.85 137 319748 5111 50280128
Blood pressure diastolic decreased 90.25 9.85 272 319613 16509 50268730
Blood pressure systolic abnormal 89.97 9.85 169 319716 7537 50277702
Acute lung injury 88.11 9.85 72 319813 1321 50283918
Glossodynia 87.65 9.85 1116 318769 114453 50170786
Disease progression 86.34 9.85 313 319572 95553 50189686
Blood pressure increased 85.98 9.85 1249 318636 131883 50153356
Neutropenia 85.23 9.85 566 319319 147399 50137840
Drug ineffective 83.91 9.85 4282 315603 815051 49470188
Hospitalisation 83.78 9.85 191 319694 67746 50217493
Sopor 83.19 9.85 13 319872 19866 50265373
Myocardial infarction 81.95 9.85 288 319597 88739 50196500
Dizziness 81.68 9.85 1621 318264 344748 49940491
Infusion site extravasation 81.46 9.85 153 319732 6823 50278416
Product quality issue 79.79 9.85 48 319837 30810 50254429
Respiratory depression 79.61 9.85 210 319675 11800 50273439
Nausea 78.90 9.85 3652 316233 701746 49583493
Suspected suicide 78.76 9.85 130 319755 5227 50280012
Feeling abnormal 78.47 9.85 468 319417 125024 50160215
Contraindicated product administered 78.24 9.85 1350 318535 147608 50137631
Arthropathy 77.93 9.85 1417 318468 156489 50128750
Drug resistance 75.97 9.85 14 319871 18975 50266264
Osteonecrosis of jaw 75.51 9.85 57 319828 32469 50252770
Decreased appetite 75.42 9.85 859 319026 200064 50085175
Infusion site erythema 75.39 9.85 169 319716 8558 50276681
Therapy cessation 73.77 9.85 36 319849 25975 50259264
Exposure via ingestion 72.38 9.85 89 319796 2714 50282525
Blood pressure systolic increased 71.82 9.85 426 319459 35023 50250216
Neuropathy peripheral 71.51 9.85 341 319544 96416 50188823
Muscle spasms 71.43 9.85 482 319403 125071 50160168
Pemphigus 71.23 9.85 1111 318774 119055 50166184
Oxygen saturation decreased 71.06 9.85 742 319143 72506 50212733
Injection site swelling 70.97 9.85 96 319789 41677 50243562
Throat irritation 68.23 9.85 374 319511 29865 50255374
Cerebrovascular accident 68.05 9.85 337 319548 94343 50190896
Therapeutic product effect incomplete 67.36 9.85 323 319562 91192 50194047
Coma 66.89 9.85 600 319285 56279 50228960
Orthostatic hypotension 66.77 9.85 365 319520 29116 50256123
Paraesthesia 66.23 9.85 466 319419 119777 50165462
Cognitive disorder 65.67 9.85 491 319394 43632 50241607
Arthralgia 65.44 9.85 3394 316491 435308 49849931
Pyrexia 63.68 9.85 2975 316910 377228 49908011
Pyroglutamate increased 63.13 9.85 37 319848 383 50284856
Cardiac failure 62.84 9.85 257 319628 75783 50209456
Rash 62.73 9.85 3372 316513 434099 49851140
Night sweats 62.04 9.85 394 319491 33180 50252059
Malignant neoplasm progression 61.61 9.85 222 319663 67902 50217337
Pyroglutamic acidosis 61.31 9.85 37 319848 406 50284833
Sedation 60.19 9.85 365 319520 30245 50254994
Infusion site pruritus 59.85 9.85 97 319788 3840 50281399
Rheumatic fever 59.76 9.85 238 319647 16629 50268610
No adverse event 58.23 9.85 76 319809 33502 50251737
Oedema peripheral 57.05 9.85 681 319204 157280 50127959
Product substitution issue 57.02 9.85 10 319875 14047 50271192
Respiratory disorder 57.02 9.85 365 319520 30822 50254417
Liver injury 56.77 9.85 308 319577 24498 50260741
Electric shock 56.50 9.85 49 319836 979 50284260
Drug interaction 56.23 9.85 905 318980 198716 50086523
Hypotension 54.27 9.85 1907 317978 233562 50051677
Injection site warmth 53.83 9.85 11 319874 13855 50271384
Swollen joint count increased 53.61 9.85 211 319674 14662 50270577
Product storage error 53.47 9.85 7 319878 12217 50273022
Device malfunction 52.81 9.85 15 319870 15106 50270133
Abortion spontaneous 52.67 9.85 116 319769 41656 50243583
Surgery 51.73 9.85 69 319816 30136 50255103
Bone marrow failure 51.62 9.85 59 319826 27565 50257674
Contusion 51.61 9.85 996 318889 111187 50174052
Interstitial lung disease 50.29 9.85 170 319715 53006 50232233
Heart rate increased 49.93 9.85 725 319160 76525 50208714
Accidental overdose 49.16 9.85 249 319636 19284 50265955
Drug intolerance 48.64 9.85 1767 318118 217337 50067902
Depression 48.58 9.85 744 319141 164679 50120560
Mucosal inflammation 48.56 9.85 114 319771 40028 50245211
Device dislocation 48.44 9.85 39 319846 21507 50263732
Epistaxis 48.06 9.85 224 319661 63730 50221509
Memory impairment 47.48 9.85 300 319585 79060 50206179
Systemic lupus erythematosus 47.37 9.85 1194 318691 139428 50145811
Unevaluable event 47.25 9.85 142 319743 45924 50239315
Palmar-plantar erythrodysaesthesia syndrome 46.94 9.85 35 319850 20063 50265176
Diabetes mellitus 46.88 9.85 156 319729 48877 50236362
Crystal urine present 46.73 9.85 52 319833 1422 50283817
International normalised ratio increased 46.11 9.85 446 319439 42706 50242533
Red blood cell sedimentation rate abnormal 45.77 9.85 23 319862 16320 50268919
White blood cells urine positive 45.69 9.85 94 319791 4484 50280755
Heart rate irregular 45.40 9.85 242 319643 19118 50266121
Anion gap abnormal 45.36 9.85 28 319857 321 50284918
Bone pain 45.34 9.85 150 319735 47079 50238160
Alanine aminotransferase increased 44.99 9.85 797 319088 87562 50197677
Injection site rash 44.95 9.85 23 319862 16154 50269085
Posterior reversible encephalopathy syndrome 44.92 9.85 19 319866 14909 50270330
Drug abuse 44.10 9.85 575 319310 59271 50225968
Infusion site bruising 44.03 9.85 63 319822 2232 50283007
White blood cell count decreased 43.75 9.85 499 319386 116223 50169016
Pancytopenia 43.68 9.85 331 319554 83699 50201540
Body temperature decreased 43.38 9.85 212 319673 16183 50269056
Suicide attempt 42.83 9.85 508 319377 51224 50234015
Injection site haemorrhage 42.77 9.85 43 319842 21303 50263936
Device issue 41.45 9.85 39 319846 19933 50265306
Psoriatic arthropathy 41.38 9.85 155 319730 46877 50238362
Injection site urticaria 41.07 9.85 13 319872 12204 50273035
Malaise 40.59 9.85 1721 318164 333811 49951428
Underdose 40.46 9.85 41 319844 20237 50265002
Lymphocyte count decreased 39.28 9.85 293 319592 26014 50259225
Urine abnormality 39.25 9.85 107 319778 6131 50279108
Soft tissue disorder 39.12 9.85 84 319801 4130 50281109
Respiratory rate increased 39.02 9.85 159 319726 11226 50274013
Renal impairment 38.87 9.85 299 319586 75362 50209877
Administration site swelling 38.58 9.85 40 319845 1007 50284232
Seizure 38.50 9.85 519 319366 117355 50167884
Neoplasm progression 38.40 9.85 79 319806 29078 50256161
Dyspnoea exertional 38.17 9.85 180 319705 51053 50234186
Suicidal ideation 37.60 9.85 201 319684 55184 50230055
Mobility decreased 37.16 9.85 711 319174 79237 50206002
Administration site pain 37.03 9.85 32 319853 636 50284603
Injection site mass 37.01 9.85 27 319858 15653 50269586
Transient ischaemic attack 36.97 9.85 94 319791 32116 50253123
Gastrooesophageal reflux disease 36.97 9.85 307 319578 76121 50209118
Poor venous access 35.91 9.85 145 319740 10195 50275044
Rash pruritic 35.70 9.85 168 319717 47678 50237561
Therapy interrupted 35.57 9.85 45 319840 20107 50265132
Anxiety 35.46 9.85 853 319032 176753 50108486
Vision blurred 34.91 9.85 323 319562 78324 50206915
Blood pressure diastolic increased 34.84 9.85 115 319770 7328 50277911
Fracture 34.78 9.85 33 319852 16800 50268439
Product prescribing error 34.77 9.85 49 319836 20912 50264327
Jaundice cholestatic 34.52 9.85 90 319795 5021 50280218
Myelodysplastic syndrome 34.51 9.85 27 319858 15105 50270134
Visual acuity reduced 34.49 9.85 46 319839 20093 50265146
Infusion site nodule 34.43 9.85 39 319846 1088 50284151
Urinary sediment present 34.36 9.85 52 319833 1939 50283300
Device difficult to use 34.17 9.85 10 319875 9876 50275363
Hyperkalaemia 34.06 9.85 172 319713 47917 50237322
Tremor 33.98 9.85 516 319369 114387 50170852
Blood parathyroid hormone decreased 33.85 9.85 3 319882 7111 50278128
Urticaria 33.82 9.85 1065 318820 128496 50156743
Drug ineffective for unapproved indication 33.11 9.85 52 319833 21229 50264010
Dehydration 33.01 9.85 723 319162 151726 50133513
Fall 32.93 9.85 1756 318129 333176 49952063
Red blood cells urine positive 32.57 9.85 61 319824 2714 50282525
Cardiac arrest 32.34 9.85 724 319161 82927 50202312
Disturbance in attention 32.07 9.85 96 319789 31090 50254149
Multiple sclerosis relapse 31.39 9.85 152 319733 42812 50242427
Hyperlipidaemia 30.93 9.85 39 319846 17451 50267788
Gait disturbance 30.89 9.85 717 319168 149288 50135951
Therapeutic response unexpected 30.83 9.85 33 319852 15882 50269357
Accidental exposure to product 30.77 9.85 62 319823 22995 50262244
Red cell distribution width increased 30.50 9.85 121 319764 8438 50276801
Palpitations 30.18 9.85 418 319467 94088 50191151
Blood pH decreased 30.11 9.85 55 319830 2400 50282839
Hypomania 30.09 9.85 79 319806 4426 50280813
Dysgeusia 30.01 9.85 135 319750 38781 50246458
Brain oedema 29.95 9.85 156 319729 12214 50273025
Full blood count decreased 29.89 9.85 60 319825 22286 50262953
Myelosuppression 29.73 9.85 25 319860 13492 50271747
Loss of consciousness 29.71 9.85 472 319413 103881 50181358
Intervertebral discitis 29.46 9.85 57 319828 2599 50282640
Substance abuse 29.28 9.85 74 319811 4050 50281189
Product use in unapproved indication 29.05 9.85 536 319349 115283 50169956
Hyponatraemia 29.02 9.85 430 319455 95709 50189530
Drug-induced liver injury 28.85 9.85 288 319597 27807 50257432
Urine leukocyte esterase positive 28.54 9.85 59 319826 2824 50282415
Neutrophil percentage increased 28.41 9.85 57 319828 2670 50282569
Injection site induration 28.11 9.85 9 319876 8388 50276851
Body temperature fluctuation 27.83 9.85 47 319838 1926 50283313
Breast cancer 27.82 9.85 158 319727 42732 50242507
Ear pruritus 27.77 9.85 54 319831 2472 50282767
Hypokalaemia 27.45 9.85 391 319494 87601 50197638
Coronary artery disease 27.45 9.85 96 319789 29630 50255609
Myalgia 27.37 9.85 588 319297 123731 50161508
Pain in extremity 27.29 9.85 1428 318457 271437 50013802
Multiple drug therapy 27.13 9.85 46 319839 1891 50283348
Hypertensive crisis 26.93 9.85 26 319859 13128 50272111
Acute kidney injury 26.85 9.85 1173 318712 226885 50058354
Gestational diabetes 26.83 9.85 7 319878 7458 50277781
Pneumonia 26.82 9.85 2044 317841 376357 49908882
Lymphocyte percentage decreased 26.76 9.85 56 319829 2704 50282535
Pain 26.64 9.85 4107 315778 574796 49710443
Incorrect drug administration rate 26.59 9.85 54 319831 2552 50282687
Burning sensation 26.56 9.85 173 319712 45273 50239966
Dry skin 26.48 9.85 162 319723 43029 50242210
Liver transplant 26.45 9.85 48 319837 2084 50283155
Brain death 26.44 9.85 56 319829 2727 50282512
Musculoskeletal disorder 26.42 9.85 43 319842 17306 50267933
Thrombocytopenia 26.36 9.85 610 319275 127063 50158176
Iron deficiency anaemia 26.32 9.85 41 319844 16793 50268446
Infusion site haemorrhage 25.75 9.85 58 319827 2946 50282293
Atrial fibrillation 25.47 9.85 471 319414 101274 50183965
Blood creatine increased 25.14 9.85 78 319807 4809 50280430
Analgesic drug level above therapeutic 24.90 9.85 15 319870 164 50285075
Specific gravity urine decreased 24.87 9.85 26 319859 661 50284578
Femur fracture 24.85 9.85 137 319748 37327 50247912
Ageusia 24.77 9.85 22 319863 11561 50273678
Drug withdrawal syndrome 24.52 9.85 79 319806 25002 50260237
Aspartate aminotransferase increased 24.42 9.85 656 319229 77342 50207897
Anion gap increased 24.25 9.85 38 319847 1461 50283778
Acidosis 24.09 9.85 128 319757 10099 50275140
Epilepsy 23.94 9.85 64 319821 21503 50263736
Hypercalcaemia 23.93 9.85 72 319813 23280 50261959
Diabetic ketoacidosis 23.89 9.85 48 319837 17824 50267415
Accidental death 23.88 9.85 41 319844 1703 50283536
Cytokine release syndrome 23.82 9.85 113 319772 8521 50276718
Platelet count decreased 23.77 9.85 471 319414 100255 50184984
Withdrawal syndrome 23.73 9.85 47 319838 17543 50267696
Macular degeneration 23.65 9.85 164 319721 14224 50271015
Gastrointestinal haemorrhage 23.51 9.85 324 319561 72997 50212242
Hypothermia 23.44 9.85 143 319742 11873 50273366
Infusion site mass 23.28 9.85 33 319852 1159 50284080
Thinking abnormal 23.20 9.85 16 319869 9551 50275688
Prothrombin time prolonged 23.18 9.85 114 319771 8724 50276515
Spinal stenosis 23.15 9.85 31 319854 13519 50271720
Syncope 23.01 9.85 486 319399 102516 50182723
Blood cholesterol increased 22.97 9.85 483 319402 54732 50230507
Full blood count abnormal 22.64 9.85 74 319811 23314 50261925
Administration site erythema 22.58 9.85 22 319863 513 50284726
Aphasia 22.48 9.85 98 319787 28396 50256843
Leukopenia 22.16 9.85 297 319588 67231 50218008
Renal failure 22.14 9.85 509 319376 106124 50179115
Second primary malignancy 22.12 9.85 8 319877 6906 50278333
Genital haemorrhage 22.09 9.85 7 319878 6567 50278672
Metastases to liver 22.06 9.85 60 319825 20044 50265195
Hypoaesthesia 21.99 9.85 624 319261 126633 50158606
Septic shock 21.97 9.85 243 319642 56932 50228307
Metastases to bone 21.85 9.85 51 319834 17944 50267295
Cytomegalovirus infection 21.73 9.85 51 319834 17911 50267328
Complication associated with device 21.68 9.85 37 319848 14618 50270621
Irritability 21.68 9.85 99 319786 28327 50256912
Lupus-like syndrome 21.56 9.85 17 319868 9474 50275765
Abdominal distension 21.33 9.85 328 319557 72575 50212664
Respiratory failure 21.32 9.85 427 319458 90754 50194485
Infusion site urticaria 21.30 9.85 29 319856 980 50284259
Hypocalcaemia 21.30 9.85 92 319793 26724 50258515
Mood swings 21.20 9.85 43 319842 15911 50269328
Basal cell carcinoma 21.18 9.85 76 319809 23280 50261959
Sepsis 21.18 9.85 659 319226 132266 50152973
Joint stiffness 21.12 9.85 109 319776 30199 50255040
Haemorrhage 20.99 9.85 226 319659 53215 50232024
Ductus arteriosus premature closure 20.93 9.85 17 319868 309 50284930
Tinnitus 20.85 9.85 99 319786 28033 50257206
Blood glucose increased 20.84 9.85 321 319564 71003 50214236
Pneumocystis jirovecii pneumonia 20.81 9.85 38 319847 14625 50270614
Haematotoxicity 20.81 9.85 12 319873 7883 50277356
Dysphonia 20.77 9.85 152 319733 38740 50246499
Osteoarthritis 20.65 9.85 307 319578 68299 50216940
Cardiac disorder 20.61 9.85 173 319712 42806 50242433
Osteonecrosis 20.60 9.85 73 319812 22444 50262795
Skin necrosis 20.53 9.85 23 319862 10844 50274395
Disease recurrence 20.52 9.85 62 319823 20019 50265220
Therapeutic response decreased 20.51 9.85 195 319690 47036 50238203
Swollen tongue 20.50 9.85 102 319783 28528 50256711
Carpal tunnel syndrome 20.41 9.85 48 319837 16845 50268394
Concomitant disease aggravated 20.34 9.85 13 319872 8078 50277161
Pulmonary hypertension 20.14 9.85 126 319759 33291 50251948
Extrapyramidal disorder 20.04 9.85 27 319858 11743 50273496
Blood urine present 19.77 9.85 144 319741 12689 50272550
Bone erosion 19.70 9.85 27 319858 11660 50273579
Bradypnoea 19.61 9.85 53 319832 3021 50282218
Temperature regulation disorder 19.51 9.85 65 319820 4162 50281077
Pathogen resistance 19.22 9.85 6 319879 5683 50279556
Blood creatinine decreased 19.08 9.85 72 319813 4904 50280335
Haemolysis 19.04 9.85 82 319803 5934 50279305
Off label use 19.03 9.85 2669 317216 471757 49813482
Body height decreased 18.95 9.85 17 319868 8891 50276348
Asthma 18.95 9.85 425 319460 88912 50196327
Chest pain 18.95 9.85 919 318966 175963 50109276
Hepatic cirrhosis 18.88 9.85 53 319832 17524 50267715
Foetal exposure during pregnancy 18.73 9.85 99 319786 27260 50257979
Vitamin D deficiency 18.57 9.85 27 319858 11375 50273864
Neurotoxicity 18.52 9.85 41 319844 14699 50270540
Hemivertebra 18.44 9.85 11 319874 118 50285121
Panniculitis 18.36 9.85 16 319869 8487 50276752
Flatulence 18.32 9.85 110 319775 29348 50255891
Bacterial test 18.26 9.85 29 319856 1128 50284111
Smear cervix abnormal 18.24 9.85 48 319837 2693 50282546
Heavy menstrual bleeding 18.10 9.85 45 319840 15492 50269747
Product adhesion issue 18.09 9.85 3 319882 4389 50280850
Infusion site irritation 18.03 9.85 21 319864 604 50284635
Speech disorder 18.01 9.85 141 319744 35407 50249832
Cerebral haemorrhage 17.90 9.85 99 319786 26953 50258286
Hallucination, auditory 17.87 9.85 25 319860 10703 50274536
Acute myocardial infarction 17.84 9.85 110 319775 29163 50256076
Injection site discolouration 17.82 9.85 11 319874 6963 50278276
Osmolar gap 17.79 9.85 10 319875 95 50285144
Hepatic encephalopathy 17.75 9.85 113 319772 9523 50275716
Post procedural pulmonary embolism 17.68 9.85 14 319871 245 50284994
Fluid retention 17.63 9.85 220 319665 50429 50234810
Polyneuropathy 17.61 9.85 31 319854 12100 50273139
Taste disorder 17.57 9.85 16 319869 8308 50276931
Hepatitis cholestatic 17.57 9.85 81 319804 6036 50279203
Skin ulcer 17.47 9.85 141 319744 35177 50250062
Angioedema 17.47 9.85 153 319732 37523 50247716
Mean cell haemoglobin concentration increased 17.46 9.85 18 319867 450 50284789
Thrombosis 17.44 9.85 248 319637 55585 50229654
Oral discomfort 17.42 9.85 15 319870 8002 50277237
Blood bilirubin increased 17.38 9.85 292 319593 31746 50253493
Eye pruritus 17.33 9.85 33 319852 12501 50272738
C-reactive protein abnormal 17.21 9.85 104 319781 27705 50257534
Skin exfoliation 17.18 9.85 133 319752 33479 50251760
Renal failure neonatal 17.11 9.85 12 319873 173 50285066
Therapeutic response shortened 17.08 9.85 92 319793 7297 50277942
Ventricular extrasystoles 17.03 9.85 25 319860 10491 50274748
Laboratory test abnormal 17.01 9.85 82 319803 23126 50262113
Bursitis 16.86 9.85 214 319671 21921 50263318
Electrolyte imbalance 16.84 9.85 54 319831 17115 50268124
Hyperglycaemia 16.81 9.85 148 319737 36257 50248982
Cardiomyopathy 16.74 9.85 47 319838 15539 50269700
Infusion site discomfort 16.69 9.85 24 319861 854 50284385
Respiratory tract congestion 16.64 9.85 41 319844 14158 50271081
Vertigo 16.63 9.85 229 319656 51603 50233636
Unresponsive to stimuli 16.61 9.85 279 319606 30330 50254909
COVID-19 immunisation 16.60 9.85 22 319863 724 50284515
Pulmonary arterial hypertension 16.57 9.85 69 319816 20250 50264989
Arrhythmia 16.51 9.85 132 319753 33000 50252239
Fear of injection 16.48 9.85 9 319876 6094 50279145
Asphyxia 16.43 9.85 73 319812 5354 50279885
Prothrombin time shortened 16.37 9.85 34 319851 1633 50283606
Drug screen positive 16.31 9.85 53 319832 3349 50281890
Right ventricular failure 16.29 9.85 49 319836 15844 50269395
Rhinitis allergic 16.23 9.85 13 319872 7187 50278052
Device breakage 16.15 9.85 22 319863 9525 50275714
Schizoaffective disorder 16.10 9.85 40 319845 2166 50283073
Febrile bone marrow aplasia 16.06 9.85 10 319875 6301 50278938
Meniscus injury 16.02 9.85 10 319875 6292 50278947
Akathisia 16.01 9.85 17 319868 8212 50277027
Sleep apnoea syndrome 15.98 9.85 87 319798 23781 50261458
Band neutrophil count increased 15.89 9.85 15 319870 336 50284903
Schizophrenia 15.70 9.85 90 319795 7307 50277932
Pericardial effusion 15.67 9.85 96 319789 25493 50259746
Lactic acidosis 15.66 9.85 135 319750 33220 50252019
Hypothyroidism 15.63 9.85 139 319746 33986 50251253
Metastases to lymph nodes 15.43 9.85 13 319872 7011 50278228
Transplant rejection 15.41 9.85 23 319862 9586 50275653
Hallucination 15.38 9.85 205 319680 46452 50238787
Inappropriate antidiuretic hormone secretion 15.36 9.85 38 319847 13105 50272134
Haemoglobin urine present 15.28 9.85 22 319863 784 50284455
Dysphagia 15.26 9.85 373 319512 77145 50208094
Uterine perforation 15.20 9.85 11 319874 6404 50278835
Ascites 15.17 9.85 149 319736 35712 50249527
Vaginal haemorrhage 15.09 9.85 92 319793 24459 50260780
Intentional self-injury 15.07 9.85 85 319800 23027 50262212
Pneumonia viral 15.06 9.85 84 319801 6750 50278489
Transfusion-related acute lung injury 15.05 9.85 9 319876 97 50285142
Culture urine positive 14.99 9.85 52 319833 3399 50281840
Lung neoplasm malignant 14.98 9.85 49 319836 15435 50269804
Loss of personal independence in daily activities 14.92 9.85 333 319552 69717 50215522
Toxicologic test abnormal 14.84 9.85 19 319866 604 50284635
Dyspnoea 14.80 9.85 3148 316737 544460 49740779
Complication of device removal 14.79 9.85 4 319881 4160 50281079
Renal papillary necrosis 14.74 9.85 12 319873 219 50285020
Administration site pruritus 14.69 9.85 13 319872 267 50284972
Treatment noncompliance 14.62 9.85 121 319764 30029 50255210
Sensitivity to weather change 14.60 9.85 10 319875 5991 50279248
Abnormal dreams 14.50 9.85 23 319862 9354 50275885
Intermenstrual bleeding 14.50 9.85 13 319872 6801 50278438
Haemophagocytic lymphohistiocytosis 14.50 9.85 20 319865 8613 50276626
Pain in jaw 14.50 9.85 164 319721 38264 50246975
Nail bed inflammation 14.49 9.85 15 319870 377 50284862
Parosmia 14.42 9.85 5 319880 4431 50280808
Weight decreased 14.42 9.85 1203 318682 220042 50065197
Metastases to lung 14.39 9.85 30 319855 10990 50274249
Gait inability 14.37 9.85 157 319728 36870 50248369
Galactorrhoea 14.36 9.85 3 319882 3720 50281519
Gout 14.33 9.85 32 319853 11438 50273801
Pregnancy with contraceptive device 14.33 9.85 4 319881 4075 50281164
Intervertebral disc degeneration 14.16 9.85 41 319844 13420 50271819
Administration site extravasation 14.14 9.85 20 319865 701 50284538
Product residue present 14.07 9.85 3 319882 3669 50281570
Lip swelling 14.03 9.85 95 319790 24641 50260598
Angina unstable 14.03 9.85 13 319872 6693 50278546
Macular oedema 13.98 9.85 3 319882 3651 50281588
Drug use disorder 13.96 9.85 47 319838 3025 50282214
Skin burning sensation 13.92 9.85 27 319858 10158 50275081
Infusion site rash 13.92 9.85 28 319857 1314 50283925
Dyskinesia 13.88 9.85 111 319774 27750 50257489
Eosinophil percentage increased 13.75 9.85 23 319862 935 50284304
Acute graft versus host disease 13.69 9.85 4 319881 3954 50281285
Immune reconstitution inflammatory syndrome 13.68 9.85 9 319876 5507 50279732
Vitamin K deficiency 13.54 9.85 15 319870 408 50284831
Colon gangrene 13.53 9.85 4 319881 4 50285235
Blood uric acid decreased 13.49 9.85 19 319866 663 50284576
Poisoning deliberate 13.49 9.85 91 319794 7821 50277418
Coma hepatic 13.45 9.85 18 319867 598 50284641
Pre-existing condition improved 13.43 9.85 15 319870 7082 50278157
Large intestine polyp 13.33 9.85 16 319869 7316 50277923
Ductus arteriosus stenosis foetal 13.33 9.85 10 319875 161 50285078
Cerebral infarction 13.26 9.85 81 319804 21523 50263716
Blindness 13.26 9.85 60 319825 17209 50268030
Ejection fraction decreased 13.25 9.85 66 319819 18454 50266785
Post transplant lymphoproliferative disorder 13.22 9.85 5 319880 4199 50281040
Blood lactic acid increased 13.22 9.85 70 319815 5515 50279724
Anaphylactic shock 13.20 9.85 74 319811 20081 50265158
Mental impairment 13.17 9.85 36 319849 12008 50273231
Tardive dyskinesia 13.11 9.85 16 319869 7263 50277976
Ischaemic stroke 13.10 9.85 54 319831 15894 50269345
Chronic kidney disease 13.01 9.85 175 319710 39596 50245643
Antidepressant drug level above therapeutic 12.99 9.85 14 319871 369 50284870
Cardiac failure acute 12.98 9.85 20 319865 8230 50277009
Low density lipoprotein increased 12.97 9.85 10 319875 5636 50279603
Alpha 1 microglobulin increased 12.96 9.85 7 319878 61 50285178
Invasive ductal breast carcinoma 12.96 9.85 11 319874 5910 50279329
Glycosylated haemoglobin increased 12.92 9.85 30 319855 10576 50274663
Sputum culture positive 12.91 9.85 28 319857 1386 50283853
Coagulation factor X level decreased 12.87 9.85 7 319878 62 50285177
Shoulder arthroplasty 12.85 9.85 3 319882 3445 50281794
Pulmonary embolism 12.81 9.85 519 319366 101185 50184054
Urine analysis abnormal 12.79 9.85 58 319827 4292 50280947
Administration site bruise 12.77 9.85 12 319873 267 50284972
Product complaint 12.75 9.85 34 319851 11432 50273807
Oedema 12.66 9.85 342 319543 69839 50215400
Pneumonia aspiration 12.63 9.85 130 319755 30874 50254365
Impaired work ability 12.62 9.85 44 319841 13596 50271643
Skin infection 12.62 9.85 126 319759 12165 50273074
Balance disorder 12.54 9.85 556 319329 70034 50215205
Transplant dysfunction 12.51 9.85 7 319878 4677 50280562
Hemiplegia 12.50 9.85 17 319868 7364 50277875
Pancreatitis 12.37 9.85 192 319693 42422 50242817
Impaired quality of life 12.36 9.85 12 319873 6044 50279195
Deafness 12.36 9.85 54 319831 15637 50269602
Foot operation 12.35 9.85 10 319875 5500 50279739
Thrombotic microangiopathy 12.28 9.85 23 319862 8768 50276471
Product physical issue 12.28 9.85 6 319879 4326 50280913
Cells in urine 12.26 9.85 10 319875 183 50285056
Coagulation factor VII level decreased 12.23 9.85 7 319878 69 50285170
Atypical femur fracture 12.22 9.85 8 319877 4908 50280331
Type 2 diabetes mellitus 12.19 9.85 294 319591 34081 50251158
Eating disorder 12.15 9.85 53 319832 15356 50269883
Myelocyte count increased 12.14 9.85 13 319872 340 50284899
Hypomagnesaemia 12.13 9.85 91 319794 23065 50262174
Multiple-drug resistance 12.12 9.85 3 319882 3311 50281928
Dysarthria 12.09 9.85 165 319720 37238 50248001
Mitral valve incompetence 12.08 9.85 63 319822 17408 50267831
Amenorrhoea 12.03 9.85 22 319863 8462 50276777
Deep vein thrombosis 12.02 9.85 362 319523 72942 50212297
Delusion 12.01 9.85 31 319854 10538 50274701
Premature delivery 11.92 9.85 94 319791 23569 50261670
Status epilepticus 11.91 9.85 44 319841 13362 50271877
Haematuria 11.88 9.85 104 319781 25509 50259730
Precancerous cells present 11.88 9.85 25 319860 1212 50284027
Drug level below therapeutic 11.85 9.85 51 319834 3689 50281550
Swelling face 11.79 9.85 248 319637 52347 50232892
Drug eruption 11.78 9.85 94 319791 23512 50261727
Urine ketone body present 11.78 9.85 37 319848 2296 50282943
Skin lesion 11.75 9.85 110 319775 26617 50258622
Base excess 11.74 9.85 7 319878 75 50285164
Flushing 11.72 9.85 527 319358 66488 50218751
Aplasia pure red cell 11.70 9.85 6 319879 4209 50281030
Neonatal respiratory acidosis 11.64 9.85 9 319876 152 50285087
Caesarean section 11.61 9.85 55 319830 15584 50269655
Cardiac failure chronic 11.61 9.85 4 319881 3559 50281680
Diaphragmatic rupture 11.59 9.85 11 319874 248 50284991
Priapism 11.58 9.85 7 319878 77 50285162
Dysphoria 11.56 9.85 8 319877 4766 50280473
Electrocardiogram QT prolonged 11.53 9.85 245 319640 51641 50233598
Hepatitis acute 11.51 9.85 88 319797 7873 50277366
Nervous system disorder 11.50 9.85 58 319827 16165 50269074
Ocular hyperaemia 11.47 9.85 78 319807 20214 50265025
Eructation 11.46 9.85 17 319868 7104 50278135
Pelvic fracture 11.46 9.85 36 319849 11484 50273755
Breast cancer female 11.42 9.85 16 319869 6846 50278393
Diplopia 11.41 9.85 73 319812 19187 50266052
Erysipelas 11.41 9.85 15 319870 6593 50278646
Intestinal haemorrhage 11.40 9.85 3 319882 3177 50282062
Gastrointestinal pain 11.32 9.85 21 319864 8035 50277204
Administration site reaction 11.28 9.85 10 319875 206 50285033
Device deployment issue 11.26 9.85 4 319881 3492 50281747
Neutrophil count decreased 11.22 9.85 214 319671 45812 50239427
Vital capacity decreased 11.20 9.85 21 319864 935 50284304
Drug tolerance 11.19 9.85 9 319876 4967 50280272
Complication of device insertion 11.18 9.85 13 319872 6028 50279211
Cardiotoxicity 11.09 9.85 17 319868 7010 50278229
Band neutrophil percentage increased 11.08 9.85 10 319875 211 50285028
Autonomic dysreflexia 11.05 9.85 12 319873 319 50284920
Gastroenteritis 11.03 9.85 94 319791 23187 50262052
Pulmonary mass 11.03 9.85 71 319814 18634 50266605
Product preparation error 11.02 9.85 7 319878 4365 50280874
Therapy non-responder 11.02 9.85 242 319643 50780 50234459
Urinary casts 11.00 9.85 17 319868 646 50284593
Epstein-Barr virus infection 10.98 9.85 17 319868 6980 50278259
Labelled drug-drug interaction medication error 10.95 9.85 32 319853 10445 50274794
Device related thrombosis 10.94 9.85 25 319860 1282 50283957
Mania 10.94 9.85 34 319851 10882 50274357
Head injury 10.93 9.85 98 319787 23922 50261317
Neuroleptic malignant syndrome 10.92 9.85 35 319850 11095 50274144
Frequent bowel movements 10.90 9.85 48 319837 13870 50271369
Traumatic liver injury 10.87 9.85 11 319874 269 50284970
Chronic obstructive pulmonary disease 10.82 9.85 256 319629 53179 50232060
Continuous haemodiafiltration 10.80 9.85 21 319864 961 50284278
Transaminases increased 10.80 9.85 241 319644 27583 50257656
Tooth extraction 10.79 9.85 26 319859 9049 50276190
Infective pulmonary exacerbation of cystic fibrosis 10.78 9.85 21 319864 7888 50277351
Metastases to central nervous system 10.71 9.85 36 319849 11246 50273993
Mean cell haemoglobin concentration decreased 10.66 9.85 41 319844 2818 50282421
Acute myeloid leukaemia 10.62 9.85 54 319831 15020 50270219
Drug level increased 10.59 9.85 176 319709 19092 50266147
Nightmare 10.57 9.85 59 319826 16027 50269212
Rheumatoid nodule 10.54 9.85 43 319842 12692 50272547
Corneal reflex decreased 10.50 9.85 8 319877 132 50285107
Urine oxalate increased 10.48 9.85 10 319875 227 50285012
Maternal exposure timing unspecified 10.44 9.85 48 319837 3572 50281667
Ear infection 10.42 9.85 226 319659 25744 50259495
Upper respiratory tract infection 10.41 9.85 513 319372 65385 50219854
Maternal exposure before pregnancy 10.41 9.85 12 319873 5585 50279654
Pleural effusion 10.40 9.85 415 319470 81039 50204200
Hemiparesis 10.40 9.85 79 319806 19969 50265270
Infusion site discolouration 10.39 9.85 16 319869 606 50284633
Allergy to plants 10.39 9.85 16 319869 606 50284633
Bacterial test positive 10.37 9.85 58 319827 4665 50280574
Impaired gastric emptying 10.35 9.85 25 319860 8693 50276546
Brain stem glioma 10.35 9.85 8 319877 135 50285104
Injection site extravasation 10.34 9.85 82 319803 7419 50277820
Left ventricular dysfunction 10.33 9.85 33 319852 10473 50274766
Congestive hepatopathy 10.33 9.85 37 319848 2457 50282782
Asthenia 10.30 9.85 1817 318068 317225 49968014
Excessive skin 10.25 9.85 8 319877 137 50285102
Infusion site reaction 10.25 9.85 34 319851 2172 50283067
Carbon monoxide poisoning 10.25 9.85 9 319876 183 50285056
Skin toxicity 10.24 9.85 6 319879 3907 50281332
Post-traumatic stress disorder 10.23 9.85 54 319831 4249 50280990
Monocyte count increased 10.23 9.85 65 319820 5474 50279765
Femoral neck fracture 10.11 9.85 20 319865 7470 50277769
Encephalopathy 10.11 9.85 282 319603 33429 50251810
Congestive cardiomyopathy 10.08 9.85 12 319873 5506 50279733
Pharyngeal paraesthesia 10.06 9.85 26 319859 1443 50283796
Magnesium deficiency 10.00 9.85 14 319871 486 50284753
Endophthalmitis 9.99 9.85 3 319882 2913 50282326
Osmolar gap abnormal 9.94 9.85 5 319880 37 50285202
Haemarthrosis 9.94 9.85 3 319882 2905 50282334
Therapy change 9.94 9.85 11 319874 5214 50280025
Muscular weakness 9.90 9.85 495 319390 94518 50190721
Death 9.88 9.85 2261 317624 323118 49962121
Unintended pregnancy 9.87 9.85 10 319875 4936 50280303

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
Completed suicide 1300.55 10.15 1794 129780 88452 29354501
Toxicity to various agents 1089.36 10.15 2388 129186 171273 29271680
Infusion related reaction 449.05 10.15 745 130829 43141 29399812
Blood pressure fluctuation 354.61 10.15 440 131134 19454 29423499
Exposure to toxic agent 321.87 10.15 178 131396 2397 29440556
Overdose 298.84 10.15 906 130668 78913 29364040
Acute hepatic failure 269.02 10.15 298 131276 11654 29431299
Intentional product misuse 232.30 10.15 491 131083 34170 29408783
Drug ineffective 206.17 10.15 875 130699 362295 29080658
Intentional overdose 165.83 10.15 460 131114 38068 29404885
Heart rate decreased 153.28 10.15 341 131233 24571 29418382
Blood pressure increased 124.70 10.15 653 130921 73150 29369803
Metabolic acidosis 112.36 10.15 396 131178 37266 29405687
Hepatic cytolysis 99.40 10.15 152 131422 8195 29434758
Oxygen saturation decreased 97.91 10.15 428 131146 44509 29398444
Product dose omission issue 90.20 10.15 183 131391 96200 29346753
Myocardial infarction 89.75 10.15 226 131348 110070 29332883
Hepatotoxicity 88.68 10.15 225 131349 17642 29425311
Coagulopathy 88.35 10.15 225 131349 17682 29425271
Anion gap 86.86 10.15 49 131525 687 29442266
Respiratory arrest 79.95 10.15 275 131299 25558 29417395
Cardio-respiratory arrest 76.83 10.15 435 131139 50166 29392787
Intentional product use issue 70.32 10.15 374 131200 42124 29400829
Respiratory depression 68.89 10.15 172 131402 13351 29429602
Hepatic necrosis 67.38 10.15 81 131493 3461 29439492
Accidental overdose 66.90 10.15 201 131373 17392 29425561
Suspected suicide 65.39 10.15 85 131489 3935 29439018
Cardiac failure congestive 64.55 10.15 154 131420 76427 29366526
Sinusitis 64.32 10.15 313 131261 34037 29408916
Diarrhoea 63.92 10.15 1069 130505 331629 29111324
Substance abuse 63.73 10.15 111 131463 6676 29436277
Heart rate irregular 62.83 10.15 163 131411 12954 29429999
Blood pressure systolic increased 61.75 10.15 190 131384 16655 29426298
Drug resistance 61.05 10.15 11 131563 21529 29421424
Hypotension 60.04 10.15 1205 130369 193149 29249804
Alanine aminotransferase increased 59.48 10.15 528 131046 70416 29372537
Chills 58.93 10.15 529 131045 70771 29372182
Blood pressure diastolic abnormal 58.06 10.15 64 131510 2487 29440466
Liver injury 57.03 10.15 154 131420 12536 29430417
Treatment failure 52.55 10.15 52 131522 36887 29406066
Poisoning 50.79 10.15 127 131447 9866 29433087
Aspartate aminotransferase increased 48.76 10.15 442 131132 59283 29383670
Drug abuse 48.38 10.15 556 131018 79327 29363626
Heart rate increased 44.29 10.15 311 131263 38627 29404326
Medication error 43.89 10.15 199 131375 21012 29421941
Analgesic drug level increased 43.20 10.15 29 131545 563 29442390
Toxic epidermal necrolysis 42.68 10.15 177 131397 17976 29424977
Blood pressure diastolic increased 42.31 10.15 66 131508 3620 29439333
Exposure via ingestion 41.45 10.15 48 131526 1970 29440983
Infusion site extravasation 40.16 10.15 59 131515 3068 29439885
Body temperature decreased 39.75 10.15 121 131453 10543 29432410
Blood pressure systolic abnormal 38.80 10.15 48 131526 2113 29440840
Cardiac failure 38.78 10.15 201 131373 79086 29363867
Infusion site pain 37.30 10.15 55 131519 2870 29440083
Therapeutic response shortened 36.97 10.15 72 131502 4719 29438234
Pyroglutamic acidosis 36.84 10.15 20 131554 259 29442694
Blood pressure diastolic decreased 36.48 10.15 90 131484 6932 29436021
Rheumatoid arthritis 36.09 10.15 256 131318 31896 29411057
Cytokine release syndrome 35.76 10.15 134 131440 12985 29429968
Coronary artery disease 35.54 10.15 91 131483 44099 29398854
Depressed level of consciousness 35.20 10.15 283 131291 36659 29406294
International normalised ratio increased 34.50 10.15 325 131249 44047 29398906
Stevens-Johnson syndrome 33.55 10.15 154 131420 16343 29426610
Renal cortical necrosis 33.41 10.15 16 131558 156 29442797
Appendicolith 32.78 10.15 57 131517 3423 29439530
Neutrophil percentage increased 32.69 10.15 40 131534 1741 29441212
Neuropathy peripheral 32.56 10.15 184 131390 70843 29372110
Drug interaction 32.20 10.15 652 130922 196733 29246220
Therapeutic product effect incomplete 31.56 10.15 81 131493 39224 29403729
Coma 31.19 10.15 290 131284 39160 29403793
Infusion site swelling 31.14 10.15 40 131534 1830 29441123
Psoriasis 31.13 10.15 60 131514 32167 29410786
Dizziness 31.10 10.15 626 130948 189058 29253895
Anaemia 30.95 10.15 670 130904 200281 29242672
Hepatic failure 30.89 10.15 243 131331 31269 29411684
Blood pH decreased 29.97 10.15 42 131532 2091 29440862
Wrong technique in product usage process 29.94 10.15 59 131515 31369 29411584
Body temperature increased 29.39 10.15 135 131439 14330 29428623
Tachycardia 29.38 10.15 469 131105 71941 29371012
Abdominal pain 29.00 10.15 798 130776 134559 29308394
Pyrexia 28.60 10.15 1558 130016 286064 29156889
Methaemoglobinaemia 28.15 10.15 46 131528 2625 29440328
Product use in unapproved indication 28.09 10.15 249 131325 86626 29356327
Depression 28.00 10.15 243 131331 84904 29358049
Suicide attempt 27.09 10.15 251 131323 33859 29409094
Contraindicated product administered 26.81 10.15 25 131549 18241 29424712
Myocardial fibrosis 26.42 10.15 28 131546 1040 29441913
Sopor 26.21 10.15 8 131566 10926 29432027
Lymphocyte percentage decreased 25.82 10.15 38 131536 1979 29440974
Memory impairment 25.71 10.15 80 131494 36390 29406563
Product prescribing error 24.77 10.15 26 131548 17950 29425003
Urine sodium decreased 24.45 10.15 13 131561 161 29442792
Injection site pain 24.44 10.15 69 131505 32377 29410576
Body temperature fluctuation 24.12 10.15 31 131543 1419 29441534
Prothrombin time prolonged 23.89 10.15 90 131484 8742 29434211
Poor venous access 23.78 10.15 47 131527 3114 29439839
Respiratory rate increased 23.78 10.15 89 131485 8619 29434334
Ductus arteriosus premature closure 23.71 10.15 14 131560 215 29442738
Hospitalisation 23.37 10.15 115 131459 45873 29397080
Asthenia 23.29 10.15 755 130819 214495 29228458
Aplastic anaemia 23.27 10.15 80 131494 7430 29435523
Bone marrow failure 23.26 10.15 55 131519 27394 29415559
Unresponsive to stimuli 23.13 10.15 191 131383 24935 29418018
Acute lung injury 22.96 10.15 29 131545 1304 29441649
Febrile neutropenia 22.71 10.15 657 130917 111583 29331370
Glycosylated haemoglobin increased 22.41 10.15 7 131567 9419 29433534
Feeling abnormal 22.34 10.15 146 131428 54299 29388654
Ear infection 22.29 10.15 83 131491 8017 29434936
Cardiac arrest 22.27 10.15 518 131056 85073 29357880
Urticaria 21.78 10.15 353 131221 54307 29388646
Cerebrovascular accident 21.66 10.15 228 131346 76683 29366270
Infusion site pruritus 21.21 10.15 18 131556 503 29442450
Cerebral artery thrombosis 21.16 10.15 21 131553 721 29442232
Inappropriate schedule of product administration 21.13 10.15 296 131278 44176 29398777
Granulomatosis with polyangiitis 21.09 10.15 23 131551 883 29442070
Visual acuity reduced 21.08 10.15 21 131553 14855 29428098
Disease progression 21.03 10.15 248 131326 81668 29361285
Nasopharyngitis 20.76 10.15 377 131197 59288 29383665
Transaminases increased 20.71 10.15 172 131402 22490 29420463
Haemolysis 20.60 10.15 73 131501 6883 29436070
Renal impairment 20.58 10.15 247 131327 81086 29361867
Fatigue 20.54 10.15 1177 130397 315644 29127309
Brain scan abnormal 20.52 10.15 22 131552 828 29442125
Balance disorder 19.82 10.15 88 131486 36082 29406871
Progressive multifocal leukoencephalopathy 19.81 10.15 7 131567 8712 29434241
Malignant neoplasm progression 19.58 10.15 222 131352 73637 29369316
Acidosis 19.29 10.15 90 131484 9615 29433338
Pulmonary oedema 18.94 10.15 281 131293 42454 29400499
Chronic gastrointestinal bleeding 18.53 10.15 13 131561 272 29442681
Dyspnoea 18.52 10.15 1229 130345 325503 29117450
Interstitial lung disease 18.40 10.15 166 131408 57552 29385401
Diabetes mellitus 18.34 10.15 103 131471 39728 29403225
Cerebral haemorrhage 18.12 10.15 75 131499 31351 29411602
Anion gap abnormal 17.93 10.15 10 131564 137 29442816
Pemphigus 17.92 10.15 24 131550 1144 29441809
Oxygen saturation abnormal 17.54 10.15 24 131550 1168 29441785
Brain death 17.54 10.15 35 131539 2335 29440618
Osteonecrosis of jaw 17.51 10.15 29 131545 16481 29426472
Throat tightness 17.34 10.15 70 131504 7021 29435932
Full blood count abnormal 17.23 10.15 25 131549 14988 29427965
Flushing 17.17 10.15 201 131373 28791 29414162
Renal papillary necrosis 17.08 10.15 10 131564 151 29442802
Victim of chemical submission 16.85 10.15 7 131567 47 29442906
Cerebral infarction 16.78 10.15 55 131519 24620 29418333
Oedema peripheral 16.57 10.15 343 131231 103214 29339739
Immune reconstitution inflammatory syndrome 16.51 10.15 7 131567 7795 29435158
Decreased appetite 16.37 10.15 507 131067 144835 29298118
Urethral valves 16.31 10.15 12 131562 271 29442682
Therapeutic response decreased 16.17 10.15 56 131518 24655 29418298
Blood triglycerides increased 16.12 10.15 20 131554 12814 29430139
Acute myocardial infarction 16.01 10.15 138 131436 48300 29394653
Haematotoxicity 15.88 10.15 5 131569 6694 29436259
Dependent personality disorder 15.79 10.15 8 131566 89 29442864
Administration site pain 15.60 10.15 10 131564 179 29442774
Graft versus host disease 15.57 10.15 12 131562 9616 29433337
Infusion site erythema 15.34 10.15 27 131547 1637 29441316
Therapeutic product effect decreased 15.34 10.15 73 131501 29378 29413575
Visual impairment 15.26 10.15 74 131500 29634 29413319
Drug ineffective for unapproved indication 15.04 10.15 25 131549 14189 29428764
Appendicitis 15.01 10.15 78 131496 8701 29434252
Mucosal inflammation 14.93 10.15 81 131493 31514 29411439
Failure to suspend medication 14.86 10.15 13 131561 379 29442574
Myopathy 14.78 10.15 15 131559 10518 29432435
Bilirubin urine present 14.76 10.15 9 131565 147 29442806
Environmental exposure 14.67 10.15 11 131563 256 29442697
Angina pectoris 14.52 10.15 69 131505 27781 29415172
Psoriatic arthropathy 14.50 10.15 27 131547 14664 29428289
Fluid retention 14.36 10.15 55 131519 23505 29419448
Foetal exposure during pregnancy 14.31 10.15 90 131484 33777 29409176
Throat irritation 14.30 10.15 77 131497 8708 29434245
Administration site erythema 14.29 10.15 7 131567 72 29442881
Pallor 13.92 10.15 149 131425 20875 29422078
Cardiac disorder 13.77 10.15 103 131471 37160 29405793
Inadequate analgesia 13.77 10.15 34 131540 2620 29440333
Asthma 13.77 10.15 91 131483 33758 29409195
Drug level below therapeutic 13.67 10.15 46 131528 4225 29438728
Anti-erythrocyte antibody positive 13.66 10.15 6 131568 47 29442906
Infusion site rash 13.65 10.15 12 131562 352 29442601
Hypoxia 13.65 10.15 291 131283 47088 29395865
Lung neoplasm malignant 13.63 10.15 27 131547 14330 29428623
Myelosuppression 13.41 10.15 21 131553 12206 29430747
Venoocclusive liver disease 13.41 10.15 7 131567 6910 29436043
Pulmonary congestion 13.36 10.15 98 131476 12338 29430615
Infusion site nodule 13.36 10.15 7 131567 84 29442869
Product quality issue 13.35 10.15 32 131542 15863 29427090
Post transplant lymphoproliferative disorder 13.20 10.15 4 131570 5489 29437464
Infusion site bruising 12.97 10.15 12 131562 377 29442576
Infusion site haemorrhage 12.94 10.15 16 131558 704 29442249
COVID-19 immunisation 12.84 10.15 8 131566 136 29442817
Hepatitis fulminant 12.82 10.15 40 131534 3531 29439422
Loss of personal independence in daily activities 12.70 10.15 64 131510 25376 29417577
Acid-base balance disorder mixed 12.66 10.15 6 131568 57 29442896
Prescribed overdose 12.60 10.15 12 131562 8671 29434282
No adverse event 12.56 10.15 38 131536 17440 29425513
Injection site swelling 12.55 10.15 14 131560 9403 29433550
Hyperlipidaemia 12.54 10.15 23 131551 12567 29430386
Anion gap increased 12.50 10.15 24 131550 1556 29441397
Endocardial fibrosis 12.50 10.15 5 131569 30 29442923
Insomnia 12.48 10.15 300 131274 88461 29354492
Prostatic specific antigen increased 12.48 10.15 23 131551 12541 29430412
Liver transplant 12.37 10.15 30 131544 2286 29440667
Labelled drug-drug interaction medication error 12.31 10.15 22 131552 12137 29430816
Tooth infection 12.23 10.15 53 131521 5486 29437467
Electrocardiogram QRS complex prolonged 12.06 10.15 43 131531 4067 29438886
Pathogen resistance 12.04 10.15 11 131563 8105 29434848
Crystal urine present 11.97 10.15 12 131562 417 29442536
Adverse event 11.90 10.15 32 131542 15259 29427694
Bacterial test 11.89 10.15 8 131566 156 29442797
Cardiac failure chronic 11.88 10.15 7 131567 6460 29436493
Parkinsonism 11.86 10.15 9 131565 7269 29435684
Haematocrit decreased 11.77 10.15 188 131386 28834 29414119
Gait disturbance 11.71 10.15 243 131331 73106 29369847
Injection site haemorrhage 11.70 10.15 12 131562 8374 29434579
Ammonia increased 11.68 10.15 42 131532 3989 29438964
Protein urine 11.58 10.15 16 131558 786 29442167
Tendonitis 11.56 10.15 11 131563 7950 29435003
Injection site reaction 11.54 10.15 20 131554 11168 29431785
Osteonecrosis 11.52 10.15 27 131547 13492 29429461
Vomiting 11.52 10.15 1095 130479 211165 29231788
Urobilinogen urine increased 11.49 10.15 11 131563 361 29442592
Bladder cancer 11.49 10.15 17 131557 10110 29432843
Monocyte percentage increased 11.40 10.15 17 131557 896 29442057
Urine abnormality 11.34 10.15 24 131550 1670 29441283
Leukopenia 11.31 10.15 175 131399 55028 29387925
Brain oedema 11.30 10.15 93 131481 12127 29430826
Pharyngeal paraesthesia 11.27 10.15 12 131562 448 29442505
Sleep disorder 11.26 10.15 63 131511 24323 29418630
Cytomegalovirus infection 11.25 10.15 59 131515 23156 29419797
Injection site pruritus 11.22 10.15 6 131568 5843 29437110
Prostate cancer 11.22 10.15 67 131507 25460 29417493
Victim of sexual abuse 11.19 10.15 3 131571 3 29442950
Bronchial dysplasia 11.18 10.15 5 131569 41 29442912
Gait inability 11.13 10.15 43 131531 18332 29424621
Ultrasound liver abnormal 11.08 10.15 7 131567 122 29442831
Crohn's disease 11.08 10.15 34 131540 2975 29439978
Mydriasis 11.06 10.15 55 131519 6030 29436923
Erectile dysfunction 11 10.15 42 131532 17967 29424986
Vessel puncture site bruise 10.98 10.15 5 131569 43 29442910
Areflexia 10.98 10.15 32 131542 2722 29440231
General physical health deterioration 10.80 10.15 362 131212 102495 29340458
C-reactive protein abnormal 10.76 10.15 8 131566 6528 29436425
Cytopenia 10.75 10.15 17 131557 9842 29433111
Enterocolitis infectious 10.72 10.15 20 131554 1269 29441684
Analgesic drug level above therapeutic 10.68 10.15 9 131565 249 29442704
Respiratory distress 10.51 10.15 201 131373 31905 29411048
Chronic obstructive pulmonary disease 10.50 10.15 124 131450 40831 29402122
Pyroglutamate increased 10.47 10.15 9 131565 256 29442697
Hypoaesthesia 10.45 10.15 171 131403 53296 29389657
Fall 10.41 10.15 664 130910 176514 29266439
Specific gravity urine decreased 10.28 10.15 6 131568 90 29442863
Mental status changes 10.22 10.15 215 131359 34712 29408241
Urine analysis abnormal 10.18 10.15 24 131550 1796 29441157
Akathisia 10.16 10.15 9 131565 6733 29436220

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
Completed suicide 4089.41 9.76 5685 362889 218729 63911429
Toxicity to various agents 3051.26 9.76 6528 362046 356985 63773173
Infusion related reaction 1129.63 9.76 2734 365840 161733 63968425
Exposure to toxic agent 846.44 9.76 494 368080 5665 64124493
Acute hepatic failure 744.15 9.76 830 367744 25282 64104876
Blood pressure fluctuation 702.46 9.76 1147 367427 50724 64079434
Overdose 676.70 9.76 2228 366346 157338 63972820
Intentional product misuse 670.00 9.76 1356 367218 70939 64059219
Intentional overdose 405.44 9.76 1283 367291 88661 64041497
Metabolic acidosis 387.06 9.76 1083 367491 69875 64060283
Rheumatoid arthritis 386.62 9.76 1910 366664 162384 63967774
Product dose omission issue 315.70 9.76 389 368185 194358 63935800
Hepatotoxicity 304.96 9.76 693 367881 39269 64090889
Muscle injury 301.69 9.76 542 368032 25895 64104263
Heart rate decreased 295.89 9.76 836 367738 54231 64075927
Sinusitis 294.54 9.76 1626 366948 144302 63985856
Folliculitis 278.28 9.76 564 368010 29513 64100645
Anti-cyclic citrullinated peptide antibody positive 277.69 9.76 764 367810 48798 64081360
Duodenal ulcer perforation 271.51 9.76 607 367967 34018 64096140
Anion gap 270.49 9.76 155 368419 1712 64128446
Sleep disorder due to general medical condition, insomnia type 262.80 9.76 509 368065 25761 64104397
Irritable bowel syndrome 261.05 9.76 626 367948 36743 64093415
Helicobacter infection 255.57 9.76 631 367943 37731 64092427
Hepatic enzyme increased 245.09 9.76 1422 367152 128521 64001637
Blood pressure increased 239.62 9.76 1748 366826 170804 63959354
Injection site pain 225.77 9.76 183 368391 111225 64018933
Lower respiratory tract infection 224.52 9.76 1103 367471 93511 64036647
Hand deformity 224.48 9.76 829 367745 61942 64068216
Pemphigus 214.00 9.76 798 367776 59903 64070255
Intentional product use issue 211.68 9.76 1091 367483 94273 64035885
Coagulopathy 209.41 9.76 522 368052 31398 64098760
Pericarditis 208.96 9.76 808 367766 61708 64068450
Respiratory arrest 205.85 9.76 719 367855 52266 64077892
Cardio-respiratory arrest 194.85 9.76 1091 367483 97302 64032856
Diarrhoea 192.00 9.76 2942 365632 719762 63410396
Hepatic cytolysis 187.82 9.76 309 368265 13740 64116418
Medication error 187.20 9.76 670 367904 49296 64080862
Ill-defined disorder 186.26 9.76 615 367959 43437 64086721
Myocardial infarction 185.41 9.76 421 368153 165400 63964758
Nasopharyngitis 184.01 9.76 1820 366754 194253 63935905
Hepatic necrosis 183.12 9.76 234 368340 8239 64121919
Glossodynia 177.54 9.76 787 367787 63909 64066249
Depressed level of consciousness 176.11 9.76 925 367649 80511 64049647
Wound 175.34 9.76 883 367691 75594 64054564
Blister 170.52 9.76 913 367661 80054 64050104
Blood pressure diastolic abnormal 167.32 9.76 268 368306 11649 64118509
Joint swelling 162.98 9.76 1915 366659 213467 63916691
Anaemia 158.62 9.76 1392 367182 377288 63752870
Oxygen saturation decreased 158.11 9.76 1102 367472 106074 64024084
Discomfort 153.01 9.76 886 367688 79992 64050166
Systemic lupus erythematosus 151.26 9.76 857 367717 76755 64053403
Poisoning 147.95 9.76 362 368212 21517 64108641
Analgesic drug level increased 146.76 9.76 114 368460 2156 64128002
Synovitis 145.65 9.76 1018 367556 98072 64032086
Impaired healing 144.84 9.76 707 367867 59766 64070392
Cardiac failure congestive 144.75 9.76 333 368241 130247 63999911
Respiratory depression 141.97 9.76 372 368202 23071 64107087
Injection site erythema 140.07 9.76 119 368455 70681 64059477
Body temperature increased 138.48 9.76 493 368081 36173 64093985
Drug interaction 136.16 9.76 1367 367207 360716 63769442
Liver injury 135.70 9.76 428 368146 29504 64100654
Weight increased 134.97 9.76 1835 366739 211513 63918645
Suspected suicide 134.57 9.76 204 368370 8450 64121708
Blood pressure diastolic decreased 134.16 9.76 353 368221 21948 64108210
Blood pressure systolic increased 132.98 9.76 598 367976 48855 64081303
Sedation complication 132.08 9.76 223 368351 10131 64120027
Drug resistance 130.01 9.76 22 368552 35080 64095078
Blood pressure systolic abnormal 129.32 9.76 216 368358 9726 64120432
Drug ineffective 122.90 9.76 3763 364811 836484 63293674
Therapeutic product effect decreased 120.68 9.76 1096 367478 114255 64015903
Wrong technique in product usage process 119.27 9.76 117 368457 64857 64065301
Sopor 118.16 9.76 15 368559 29646 64100512
Hepatic failure 116.85 9.76 625 367949 54769 64075389
Heart rate irregular 112.57 9.76 379 368195 27034 64103124
Psoriasis 111.13 9.76 148 368426 71555 64058603
Creatinine renal clearance decreased 111.00 9.76 251 368323 14170 64115988
Cardiac failure 110.93 9.76 386 368188 131987 63998171
Accidental overdose 109.89 9.76 431 368143 33126 64097032
Heart rate increased 109.11 9.76 949 367625 97726 64032432
Exposure via ingestion 106.91 9.76 136 368438 4766 64125392
Throat irritation 103.79 9.76 416 368158 32295 64097863
Arthropathy 102.96 9.76 1101 367473 119866 64010292
Swelling 102.90 9.76 1382 367192 158836 63971322
Blood calcium decreased 102.03 9.76 350 368224 25204 64104954
Hypotension 99.69 9.76 2866 365708 378108 63752050
Acute lung injury 97.67 9.76 98 368476 2633 64127525
Device expulsion 96.79 9.76 6 368568 21130 64109028
Pyroglutamic acidosis 95.79 9.76 57 368517 679 64129479
Coma 93.94 9.76 837 367737 86778 64043380
Osteonecrosis of jaw 93.10 9.76 56 368518 39769 64090389
Injection site reaction 92.83 9.76 78 368496 46586 64083572
Death 92.79 9.76 3501 365073 479204 63650954
Bone marrow failure 89.57 9.76 85 368489 47867 64082291
Substance abuse 88.03 9.76 176 368398 9116 64121042
Gastrointestinal disorder 87.60 9.76 840 367734 88869 64041289
Neutropenia 84.51 9.76 918 367656 238706 63891452
Injection site pruritus 83.21 9.76 57 368517 37769 64092389
Interstitial lung disease 81.18 9.76 286 368288 97446 64032712
Injection site swelling 81.18 9.76 70 368504 41283 64088875
Injection site bruising 79.76 9.76 55 368519 36318 64093840
Alanine aminotransferase increased 79.49 9.76 1175 367399 137856 63992302
Body temperature decreased 77.71 9.76 324 368250 25604 64104554
Cerebrovascular accident 77.67 9.76 464 368110 137119 63993039
Disease progression 76.76 9.76 484 368090 141196 63988962
Product use in unapproved indication 76.11 9.76 644 367930 175974 63954184
Coronary artery disease 72.84 9.76 147 368427 60286 64069872
Blood pressure diastolic increased 72.80 9.76 178 368396 10574 64119584
Decreased appetite 72.27 9.76 1151 367423 280138 63850020
Contraindicated product administered 71.22 9.76 935 367639 106894 64023264
Hypersensitivity 70.96 9.76 1544 367030 194908 63935250
Drug abuse 69.62 9.76 1103 367471 131271 63998887
Ear pain 69.10 9.76 306 368268 24830 64105328
Hospitalisation 68.73 9.76 211 368363 74996 64055162
Renal impairment 67.72 9.76 472 368102 134545 63995613
Product prescribing error 64.15 9.76 64 368510 35205 64094953
Neutrophil percentage increased 63.82 9.76 101 368473 4344 64125814
Therapeutic product effect incomplete 63.81 9.76 339 368235 103143 64027015
Oedema peripheral 63.67 9.76 833 367741 209484 63920674
Malignant neoplasm progression 63.52 9.76 381 368193 112490 64017668
Rheumatoid factor positive 61.71 9.76 376 368198 34562 64095596
Dizziness 61.44 9.76 1931 366643 428232 63701926
Neuropathy peripheral 61.35 9.76 406 368168 117119 64013039
Pancytopenia 61.08 9.76 524 368050 142785 63987373
White blood cells urine positive 60.72 9.76 110 368464 5288 64124870
Anion gap abnormal 60.50 9.76 38 368536 502 64129656
Respiratory rate increased 60.46 9.76 236 368338 18095 64112063
Cognitive disorder 59.93 9.76 528 368046 54559 64075599
Mucosal inflammation 59.77 9.76 172 368402 62412 64067746
Sedation 59.73 9.76 424 368150 41038 64089120
Crystal urine present 59.60 9.76 64 368510 1865 64128293
Feeling abnormal 59.43 9.76 483 368091 133119 63997039
International normalised ratio increased 58.92 9.76 702 367872 78465 64051693
Electric shock 56.80 9.76 49 368525 1080 64129078
Therapy cessation 56.78 9.76 61 368513 32428 64097730
Dyspnoea 56.69 9.76 3447 365127 715227 63414931
Pyroglutamate increased 56.53 9.76 39 368535 609 64129549
Urine abnormality 56.51 9.76 128 368446 7234 64122924
Suicide attempt 56.12 9.76 637 367937 70370 64059788
Aspartate aminotransferase increased 55.94 9.76 979 367595 118809 64011349
Lymphocyte percentage decreased 55.19 9.76 97 368477 4552 64125606
Therapeutic response shortened 55.18 9.76 155 368419 10015 64120143
Blood pH decreased 53.76 9.76 93 368481 4309 64125849
Injection site warmth 53.16 9.76 7 368567 13455 64116703
Poor venous access 53.05 9.76 174 368400 12243 64117915
Arthralgia 52.96 9.76 3060 365514 439200 63690958
Pneumonia 52.35 9.76 2639 365935 556937 63573221
Body temperature fluctuation 51.64 9.76 78 368496 3220 64126938
Diabetes mellitus 50.33 9.76 202 368372 66272 64063886
Peripheral swelling 49.33 9.76 1554 367020 207599 63922559
Stomatitis 48.77 9.76 889 367685 108716 64021442
Product quality issue 48.77 9.76 59 368515 29740 64100418
Cytokine release syndrome 48.06 9.76 241 368333 20588 64109570
Drug ineffective for unapproved indication 47.48 9.76 65 368509 31068 64099090
Acute kidney injury 47.28 9.76 2092 366482 447148 63683010
Cerebral haemorrhage 46.92 9.76 143 368431 50947 64079211
Muscle spasms 46.24 9.76 549 368025 140474 63989684
Posterior reversible encephalopathy syndrome 46.07 9.76 38 368536 22908 64107250
Dehydration 45.48 9.76 919 367655 215844 63914314
Acute myocardial infarction 45.46 9.76 224 368350 69494 64060664
Hyperlipidaemia 44.97 9.76 39 368535 22937 64107221
Epistaxis 44.91 9.76 352 368222 97779 64032379
Leukopenia 44.56 9.76 367 368207 100875 64029283
Drug hypersensitivity 44.48 9.76 1027 367547 236788 63893370
Muscle spasticity 44.37 9.76 201 368373 16468 64113690
Palmar-plantar erythrodysaesthesia syndrome 44.12 9.76 60 368514 28759 64101399
Lymphocyte count decreased 43.70 9.76 389 368185 40310 64089848
Gait disturbance 43.64 9.76 706 367868 171449 63958709
Prothrombin time prolonged 43.55 9.76 192 368382 15549 64114609
Hyperkalaemia 43.42 9.76 369 368205 100760 64029398
Septic shock 43.38 9.76 389 368185 105048 64025110
Atrial fibrillation 43.25 9.76 702 367872 170387 63959771
Visual acuity reduced 43.09 9.76 55 368519 27086 64103072
Infusion site extravasation 42.94 9.76 110 368464 6727 64123431
Myelosuppression 42.48 9.76 44 368530 23786 64106372
Neoplasm progression 41.79 9.76 109 368465 40855 64089303
Underdose 41.36 9.76 52 368522 25777 64104381
Cytomegalovirus infection 41.08 9.76 95 368479 37104 64093054
Urinary sediment present 41.06 9.76 57 368517 2177 64127981
Cerebral infarction 40.52 9.76 111 368463 40933 64089225
Orthostatic hypotension 40.48 9.76 427 368147 46311 64083847
Device issue 40.16 9.76 42 368532 22606 64107552
Product storage error 40.14 9.76 13 368561 13305 64116853
Injection site rash 39.89 9.76 20 368554 15722 64114436
Paraesthesia 39.88 9.76 535 368039 133987 63996171
Memory impairment 39.83 9.76 306 368268 85376 64044782
Injection site haemorrhage 39.80 9.76 48 368526 24230 64105928
Infusion site pain 39.42 9.76 140 368434 10257 64119901
Red cell distribution width increased 39.41 9.76 157 368417 12152 64118006
Injection site mass 39.37 9.76 25 368549 17245 64112913
Flushing 39.33 9.76 650 367924 77998 64052160
Product substitution issue 39.17 9.76 27 368547 17834 64112324
Brain death 38.97 9.76 86 368488 4775 64125383
Cardiac arrest 38.25 9.76 1152 367422 152912 63977246
Haematotoxicity 38.14 9.76 13 368561 12883 64117275
Urine leukocyte esterase positive 37.84 9.76 69 368505 3334 64126824
Contusion 37.75 9.76 885 367689 113080 64017078
Dyspnoea exertional 37.32 9.76 257 368317 73473 64056685
Electrocardiogram QT prolonged 37.28 9.76 283 368291 79165 64050993
Surgery 37.19 9.76 65 368509 28148 64102010
Syncope 37.17 9.76 655 367919 156980 63973178
Loss of personal independence in daily activities 36.95 9.76 252 368322 72202 64057956
Rheumatic fever 36.84 9.76 127 368447 9167 64120991
Drug intolerance 36.32 9.76 1365 367209 186627 63943531
Haemolysis 36.31 9.76 142 368432 10897 64119261
Immune reconstitution inflammatory syndrome 36.15 9.76 13 368561 12457 64117701
Fall 35.66 9.76 1983 366591 414843 63715315
Device malfunction 35.65 9.76 29 368545 17604 64112554
Pain 35.45 9.76 3646 364928 549865 63580293
Asthenia 35.06 9.76 2045 366529 425999 63704159
Transient ischaemic attack 34.89 9.76 132 368442 44050 64086108
Diabetic ketoacidosis 34.77 9.76 74 368500 29771 64100387
Urticaria 34.56 9.76 1094 367480 146223 63983935
Red blood cell sedimentation rate abnormal 34.00 9.76 26 368548 16280 64113878
Jaundice cholestatic 33.95 9.76 118 368456 8552 64121606
Second primary malignancy 33.87 9.76 14 368560 12323 64117835
Specific gravity urine decreased 33.48 9.76 31 368543 752 64129406
Red blood cells urine positive 33.42 9.76 77 368497 4401 64125757
Myelodysplastic syndrome 33.30 9.76 67 368507 27512 64102646
Pathogen resistance 33.22 9.76 15 368559 12528 64117630
Infusion site pruritus 33.07 9.76 56 368518 2550 64127608
Acidosis 33.01 9.76 194 368380 17601 64112557
Analgesic drug level above therapeutic 32.96 9.76 24 368550 410 64129748
General physical health deterioration 32.77 9.76 903 367671 203522 63926636
Therapy interrupted 32.44 9.76 40 368534 19996 64110162
Device difficult to use 32.43 9.76 8 368566 9790 64120368
Infusion site swelling 32.35 9.76 86 368488 5379 64124779
Injection site induration 32.20 9.76 6 368568 8926 64121232
Unresponsive to stimuli 32.02 9.76 434 368140 49959 64080199
Brain oedema 31.94 9.76 226 368348 21849 64108309
Renal failure 31.91 9.76 792 367782 180896 63949262
Unevaluable event 31.90 9.76 164 368410 50325 64079833
Anion gap increased 31.69 9.76 60 368514 2984 64127174
Nausea 31.64 9.76 3971 364603 781829 63348329
Loss of consciousness 31.41 9.76 628 367946 147737 63982421
Malaise 31.38 9.76 1899 366675 394348 63735810
Blood parathyroid hormone decreased 31.17 9.76 3 368571 7363 64122795
Ear pruritus 30.93 9.76 55 368519 2605 64127553
Device dislocation 30.53 9.76 46 368528 21132 64109026
Haematuria 30.50 9.76 211 368363 60260 64069898
Gastrointestinal haemorrhage 30.48 9.76 552 368022 131760 63998398
Injection site urticaria 30.20 9.76 13 368561 11168 64118990
Renal papillary necrosis 29.64 9.76 21 368553 343 64129815
Extrapyramidal disorder 29.63 9.76 41 368533 19511 64110647
Pruritus 29.41 9.76 2118 366456 310282 63819876
Post transplant lymphoproliferative disorder 29.33 9.76 9 368565 9535 64120623
Night sweats 29.21 9.76 325 368249 35721 64094437
Glycosylated haemoglobin increased 29.21 9.76 29 368545 15990 64114168
No adverse event 29.13 9.76 76 368498 28485 64101673
Infusion site erythema 29.08 9.76 96 368478 6777 64123381
Liver transplant 29.05 9.76 69 368505 4023 64126135
Bacterial test 28.75 9.76 35 368539 1172 64128986
Cardiac failure chronic 28.74 9.76 8 368566 9033 64121125
Urine analysis abnormal 28.60 9.76 85 368489 5671 64124487
Epilepsy 28.59 9.76 97 368477 33434 64096724
Drug-induced liver injury 28.52 9.76 406 368168 47237 64082921
Disturbance in attention 28.52 9.76 129 368445 40945 64089213
Depression 28.51 9.76 813 367761 182478 63947680
Iron deficiency anaemia 28.34 9.76 51 368523 21838 64108320
Labelled drug-drug interaction medication error 28.03 9.76 52 368522 22010 64108148
Hypertensive crisis 27.92 9.76 38 368536 18210 64111948
Hypocalcaemia 27.88 9.76 133 368441 41620 64088538
Full blood count abnormal 27.53 9.76 83 368491 29674 64100484
Swollen joint count increased 27.01 9.76 101 368473 7588 64122570
Maternal exposure during pregnancy 26.84 9.76 728 367846 95156 64035002
Bilirubin urine present 26.78 9.76 19 368555 311 64129847
Multiple-drug resistance 26.61 9.76 3 368571 6499 64123659
Sexual dysfunction 26.45 9.76 3 368571 6468 64123690
Lactic acidosis 26.39 9.76 224 368350 61186 64068972
Abortion spontaneous 26.34 9.76 66 368508 25077 64105081
Soft tissue disorder 26.31 9.76 58 368516 3218 64126940
Hyponatraemia 26.21 9.76 646 367928 147693 63982465
Osteonecrosis 25.92 9.76 79 368495 28150 64102008
Myalgia 25.58 9.76 700 367874 157917 63972241
Bursitis 25.50 9.76 210 368364 21275 64108883
Transaminases increased 25.50 9.76 377 368197 44217 64085941
C-reactive protein abnormal 25.47 9.76 83 368491 28964 64101194
Multiple drug therapy 25.44 9.76 46 368528 2208 64127950
Drug screen positive 25.12 9.76 81 368493 5648 64124510
Abdominal discomfort 25.02 9.76 1278 367296 181044 63949114
Thrombocytopenia 24.76 9.76 1036 367538 222765 63907393
Thinking abnormal 24.64 9.76 18 368556 11538 64118620
Hepatic encephalopathy 24.52 9.76 205 368369 20861 64109297
Lung neoplasm malignant 24.31 9.76 54 368520 21394 64108764
Drug level below therapeutic 24.30 9.76 95 368479 7289 64122869
Aplastic anaemia 24.07 9.76 149 368425 13771 64116387
Cardiac failure acute 24.05 9.76 35 368539 16309 64113849
Fracture 24.01 9.76 44 368530 18711 64111447
Renal cortical necrosis 23.97 9.76 17 368557 278 64129880
Asthma 23.95 9.76 391 368183 94834 64035324
Forced expiratory volume decreased 23.94 9.76 5 368569 6862 64123296
Angina unstable 23.88 9.76 32 368542 15435 64114723
Acute graft versus host disease 23.84 9.76 11 368563 9073 64121085
Blood urine present 23.82 9.76 183 368391 18157 64112001
Inappropriate antidiuretic hormone secretion 23.75 9.76 58 368516 22231 64107927
Smear cervix abnormal 23.74 9.76 46 368528 2328 64127830
Psoriatic arthropathy 23.34 9.76 148 368426 43133 64087025
Vision blurred 23.33 9.76 369 368205 89947 64040211
Toxic epidermal necrolysis 23.17 9.76 319 368255 36847 64093311
Acute myeloid leukaemia 23.04 9.76 80 368494 27383 64102775
Graft versus host disease 22.97 9.76 27 368547 13786 64116372
Tremor 22.92 9.76 658 367916 147572 63982586
Angina pectoris 22.88 9.76 157 368417 44924 64085234
Seizure 22.83 9.76 753 367821 166139 63964019
Temperature regulation disorder 22.67 9.76 64 368510 4147 64126011
Infusion site mass 22.64 9.76 28 368546 953 64129205
Basal cell carcinoma 22.53 9.76 95 368479 30743 64099415
Coronary arterial stent insertion 22.38 9.76 3 368571 5689 64124469
Spinal stenosis 22.35 9.76 28 368546 13903 64116255
Full blood count decreased 22.34 9.76 61 368513 22521 64107637
Prostate cancer 22.30 9.76 50 368524 19745 64110413
Culture urine positive 22.26 9.76 63 368511 4088 64126070
Hypomania 22.18 9.76 77 368497 5577 64124581
Intervertebral discitis 22.13 9.76 60 368514 3797 64126361
Granuloma skin 22.07 9.76 4 368570 6070 64124088
Appendicolith 21.98 9.76 56 368518 3413 64126745
Cardiomyopathy 21.86 9.76 73 368501 25283 64104875
Blood creatinine decreased 21.83 9.76 89 368485 6961 64123197
Status epilepticus 21.83 9.76 58 368516 21605 64108553
Rash pruritic 21.80 9.76 216 368358 57188 64072970
Therapeutic response unexpected 21.66 9.76 40 368534 16961 64113197
Hypothermia 21.42 9.76 190 368384 19666 64110492
Withdrawal syndrome 21.39 9.76 66 368508 23426 64106732
Granulomatosis with polyangiitis 21.10 9.76 41 368533 2079 64128079
Oedema 21.03 9.76 384 368190 91551 64038607
Concomitant disease aggravated 20.93 9.76 21 368553 11521 64118637
Haemorrhage 20.90 9.76 323 368251 79028 64051130
Pneumocystis jirovecii pneumonia 20.90 9.76 84 368490 27550 64102608
Metastases to lymph nodes 20.73 9.76 12 368562 8705 64121453
Endophthalmitis 20.69 9.76 3 368571 5362 64124796
Confusional state 20.69 9.76 1747 366827 259397 63870761
Mobility decreased 20.52 9.76 639 367935 85201 64044957
Thrombotic microangiopathy 20.51 9.76 40 368534 16615 64113543
Pain in extremity 20.50 9.76 1473 367101 301612 63828546
Hypercalcaemia 20.44 9.76 101 368473 31315 64098843
Monocyte percentage increased 20.30 9.76 39 368535 1961 64128197
Rash 20.19 9.76 2951 365623 455598 63674560
Blood triglycerides increased 20.18 9.76 49 368525 18817 64111341
Haematochezia 20.01 9.76 263 368311 66110 64064048
Deep vein thrombosis 19.98 9.76 453 368121 104729 64025429
Cardiac disorder 19.97 9.76 213 368361 55603 64074555
Suicidal ideation 19.94 9.76 264 368310 66278 64063880
Ageusia 19.92 9.76 30 368544 13783 64116375
Hepatic cirrhosis 19.85 9.76 80 368494 26218 64103940
Myopathy 19.64 9.76 45 368529 17635 64112523
Dry skin 19.64 9.76 192 368382 50969 64079189
Aspergillus infection 19.60 9.76 40 368534 16339 64113819
Poisoning deliberate 19.60 9.76 138 368436 13320 64116838
Infection 19.58 9.76 1266 367308 183614 63946544
Bacterial test positive 19.58 9.76 83 368491 6607 64123551
Hypomagnesaemia 19.55 9.76 129 368445 37247 64092911
Polyneuropathy 19.49 9.76 54 368520 19840 64110318
Angioedema 19.36 9.76 243 368331 61578 64068580
Speech disorder 19.36 9.76 180 368394 48261 64081897
Hemiparesis 19.34 9.76 96 368478 29731 64100427
Inappropriate schedule of product administration 19.25 9.76 676 367898 91610 64038548
Cytopenia 19.18 9.76 37 368537 15434 64114724
Pharyngeal paraesthesia 18.99 9.76 37 368537 1880 64128278
Subdural haematoma 18.94 9.76 89 368485 27965 64102193
Carotid artery stenosis 18.79 9.76 11 368563 7930 64122228
Coronary artery bypass 18.76 9.76 5 368569 5810 64124348
Alopecia 18.73 9.76 1141 367433 164549 63965609
Febrile bone marrow aplasia 18.72 9.76 22 368552 11233 64118925
Methaemoglobinaemia 18.64 9.76 61 368513 4287 64125871
Maternal exposure timing unspecified 18.52 9.76 45 368529 2662 64127496
Accidental death 18.50 9.76 55 368519 3670 64126488
Neurotoxicity 18.47 9.76 87 368487 27317 64102841
Urine bilirubin decreased 18.20 9.76 11 368563 135 64130023
Hepatocellular carcinoma 18.03 9.76 13 368561 8390 64121768
Osmolar gap 18.00 9.76 11 368563 138 64130020
Toxicologic test abnormal 17.82 9.76 28 368546 1197 64128961
Pulmonary embolism 17.80 9.76 670 367904 145686 63984472
Transplant dysfunction 17.80 9.76 8 368566 6700 64123458
Chills 17.78 9.76 957 367617 136307 63993851
Dysarthria 17.69 9.76 236 368338 59170 64070988
Gestational diabetes 17.67 9.76 5 368569 5585 64124573
Aphasia 17.67 9.76 149 368425 40757 64089401
Precancerous cells present 17.59 9.76 25 368549 976 64129182
Platelet count decreased 17.58 9.76 781 367793 166930 63963228
Chronic graft versus host disease 17.43 9.76 7 368567 6269 64123889
Mean cell haemoglobin concentration increased 17.42 9.76 22 368552 765 64129393
Sputum culture positive 17.29 9.76 47 368527 2979 64127179
Band neutrophil count increased 17.26 9.76 20 368554 635 64129523
Chest pain 17.25 9.76 1139 367435 234841 63895317
Thrombosis 17.13 9.76 292 368282 70350 64059808
Prostatic specific antigen increased 16.98 9.76 15 368559 8745 64121413
Sepsis 16.97 9.76 1111 367463 229230 63900928
Infusion site bruising 16.95 9.76 31 368543 1501 64128657
Pyrexia 16.91 9.76 3525 365049 555119 63575039
Bone erosion 16.89 9.76 25 368549 11570 64118588
Serum sickness 16.71 9.76 48 368526 3141 64127017
Akathisia 16.59 9.76 25 368549 11485 64118673
Graft versus host disease in skin 16.51 9.76 5 368569 5342 64124816
Transplant rejection 16.48 9.76 48 368526 17353 64112805
Hypokalaemia 16.43 9.76 551 368023 121352 64008806
Burning sensation 16.40 9.76 193 368381 49471 64080687
Congestive cardiomyopathy 16.38 9.76 21 368553 10323 64119835
Pulmonary mass 16.33 9.76 76 368498 23940 64106218
Vertigo 16.30 9.76 238 368336 58773 64071385
Panniculitis 16.28 9.76 16 368558 8863 64121295
Fluid retention 16.25 9.76 241 368333 59365 64070793
Chronic obstructive pulmonary disease 16.17 9.76 297 368277 70751 64059407
Haematocrit decreased 16.16 9.76 418 368156 54237 64075921
Tachycardia 16.15 9.76 1026 367548 148553 63981605
Visual impairment 16.14 9.76 312 368262 73765 64056393
Mania 16.11 9.76 44 368530 16242 64113916
Dyspnoea at rest 16.10 9.76 8 368566 6321 64123837
Ejection fraction decreased 16.08 9.76 97 368477 28610 64101548
Mean cell haemoglobin concentration decreased 16.07 9.76 52 368522 3632 64126526
Skin ulcer 16.06 9.76 167 368407 43807 64086351
Eosinophil percentage increased 15.99 9.76 29 368545 1395 64128763
Left ventricular dysfunction 15.89 9.76 47 368527 16907 64113251
Haemoglobin urine present 15.83 9.76 22 368552 841 64129317
Blood bilirubin increased 15.82 9.76 436 368138 57117 64073041
Right ventricular failure 15.78 9.76 66 368508 21405 64108753
COVID-19 immunisation 15.75 9.76 18 368556 563 64129595
Injection site extravasation 15.55 9.76 89 368485 7997 64122161
Rhinitis allergic 15.46 9.76 14 368560 8064 64122094
Post-traumatic stress disorder 15.41 9.76 56 368518 4149 64126009
Respiratory disorder 15.39 9.76 291 368283 35820 64094338
Anxiety 15.34 9.76 975 367599 201674 63928484
Incorrect drug administration rate 15.30 9.76 42 368532 2677 64127481
Bone pain 15.27 9.76 186 368388 47386 64082772
Fibromyalgia 15.25 9.76 288 368286 35443 64094715
Oxygen saturation abnormal 15.22 9.76 50 368524 3521 64126637
Pain in jaw 15.20 9.76 154 368420 40601 64089557
Treatment noncompliance 15.13 9.76 167 368407 43315 64086843
Hallucination 15.12 9.76 309 368265 72479 64057679
Cells in urine 15.10 9.76 11 368563 188 64129970
Mitral valve incompetence 15.00 9.76 85 368489 25453 64104705
Anti-erythrocyte antibody positive 14.90 9.76 8 368566 77 64130081
Food allergy 14.83 9.76 86 368488 7765 64122393
Urinary casts 14.73 9.76 24 368550 1058 64129100
Ventricular tachycardia 14.71 9.76 125 368449 34140 64096018
Brain scan abnormal 14.69 9.76 25 368549 1143 64129015
Fungal rhinitis 14.68 9.76 7 368567 51 64130107
Obesity 14.62 9.76 64 368510 20498 64109660
Pulmonary hypertension 14.49 9.76 167 368407 42972 64087186
Gastrooesophageal reflux disease 14.43 9.76 363 368211 82780 64047378
Eyelid ptosis 14.41 9.76 20 368554 9505 64120653
Dyslipidaemia 14.39 9.76 19 368555 9223 64120935
Injection site discolouration 14.29 9.76 11 368563 6864 64123294
Blood glucose increased 14.25 9.76 439 368135 97634 64032524
Macular oedema 14.23 9.76 5 368569 4862 64125296
Skin exfoliation 14.22 9.76 176 368398 44709 64085449
Diplopia 14.19 9.76 92 368482 26673 64103485
Chronic kidney disease 14.17 9.76 239 368335 57680 64072478
Specific gravity urine increased 14.14 9.76 15 368559 431 64129727
Dependent personality disorder 14.13 9.76 9 368565 122 64130036
Sinus node dysfunction 14.09 9.76 11 368563 6817 64123341
Pulmonary arterial hypertension 14.06 9.76 86 368488 25281 64104877
Actinic keratosis 13.96 9.76 6 368568 5159 64124999
Drug withdrawal syndrome 13.96 9.76 113 368461 31178 64098980
Abnormal loss of weight 13.95 9.76 13 368561 7387 64122771
Swollen tongue 13.92 9.76 130 368444 34824 64095334
Lipodystrophy acquired 13.90 9.76 3 368571 4024 64126134
Metastases to liver 13.89 9.76 80 368494 23861 64106297
Musculoskeletal stiffness 13.83 9.76 848 367726 122358 64007800
Enthesopathy 13.83 9.76 21 368553 9617 64120541
Ischaemic stroke 13.82 9.76 103 368471 28932 64101226
Metastases to lung 13.81 9.76 43 368531 15221 64114937
Erysipelas 13.80 9.76 19 368555 9062 64121096
Nocardiosis 13.77 9.76 5 368569 4762 64125396
Hypoaesthesia 13.72 9.76 652 367922 138456 63991702
Nasal necrosis 13.70 9.76 9 368565 129 64130029
Lymphoproliferative disorder 13.68 9.76 6 368568 5097 64125061
Oesophageal carcinoma 13.65 9.76 5 368569 4738 64125420
Agranulocytosis 13.63 9.76 146 368428 38083 64092075
White blood cell count decreased 13.62 9.76 750 367824 157087 63973071
PCO2 decreased 13.61 9.76 42 368532 2860 64127298
Aplasia pure red cell 13.61 9.76 12 368562 7002 64123156
Dysgeusia 13.61 9.76 188 368386 46859 64083299
Nocturia 13.59 9.76 27 368547 11138 64119020
Diffuse large B-cell lymphoma 13.54 9.76 24 368550 10337 64119821
Delusion 13.47 9.76 55 368519 17959 64112199
Decerebrate posture 13.43 9.76 10 368564 177 64129981
Leukoencephalopathy 13.42 9.76 12 368562 6955 64123203
Cytomegalovirus viraemia 13.34 9.76 26 368548 10802 64119356
Gynaecomastia 13.32 9.76 9 368565 6007 64124151
Anaphylactic shock 13.31 9.76 110 368464 30218 64099940
Mydriasis 13.31 9.76 140 368434 15172 64114986
Skin necrosis 13.23 9.76 40 368534 14289 64115869
Palpitations 13.23 9.76 476 368098 104012 64026146
Disturbance in social behaviour 13.21 9.76 3 368571 3884 64126274
Infusion site urticaria 13.18 9.76 17 368557 604 64129554
Skin toxicity 13.17 9.76 11 368563 6591 64123567
Multiple sclerosis relapse 13.14 9.76 161 368413 40974 64089184
Disorientation 13.14 9.76 232 368342 55596 64074562
Blood creatine increased 13.12 9.76 86 368488 8106 64122052
Gait inability 13.09 9.76 167 368407 42201 64087957
Blood lactic acid increased 13.07 9.76 103 368471 10298 64119860
Alpha 1 microglobulin increased 13.07 9.76 7 368567 67 64130091
Pneumonia viral 13.07 9.76 83 368491 7739 64122419
Monocyte count increased 13.05 9.76 85 368489 7994 64122164
Blood uric acid decreased 13.03 9.76 23 368551 1083 64129075
Low density lipoprotein increased 13.01 9.76 15 368559 7725 64122433
Rhabdomyolysis 12.98 9.76 412 368162 91314 64038844
Urobilinogen urine increased 12.95 9.76 17 368557 615 64129543
Epstein-Barr virus infection 12.91 9.76 33 368541 12455 64117703
Ischaemic cardiomyopathy 12.91 9.76 12 368562 6826 64123332
Hypertriglyceridaemia 12.87 9.76 28 368546 11177 64118981
Device leakage 12.86 9.76 17 368557 8249 64121909
Prescribed underdose 12.85 9.76 56 368518 17959 64112199
Rebound effect 12.84 9.76 6 368568 4911 64125247
Arrhythmia 12.78 9.76 219 368355 52725 64077433
Electrolyte imbalance 12.76 9.76 88 368486 25155 64105003
Cystitis haemorrhagic 12.76 9.76 16 368558 7940 64122218
Skin lesion 12.74 9.76 140 368434 36342 64093816
Hepatitis B reactivation 12.71 9.76 6 368568 4883 64125275
Neuroleptic malignant syndrome 12.71 9.76 87 368487 24909 64105249
Brain stem glioma 12.70 9.76 9 368565 147 64130011
Tricuspid valve incompetence 12.66 9.76 52 368522 16951 64113207
Mood swings 12.65 9.76 54 368520 17414 64112744
Abnormal dreams 12.64 9.76 25 368549 10331 64119827
Acute coronary syndrome 12.61 9.76 62 368512 19248 64110910
Squamous cell carcinoma 12.60 9.76 39 368535 13830 64116328
Genital haemorrhage 12.58 9.76 8 368566 5514 64124644
Partial seizures 12.46 9.76 14 368560 7293 64122865
Candida infection 12.44 9.76 117 368457 31302 64098856
Frequent bowel movements 12.40 9.76 58 368516 18247 64111911
Venoocclusive liver disease 12.38 9.76 24 368550 9991 64120167
Pulmonary alveolar haemorrhage 12.33 9.76 23 368551 9715 64120443
Product monitoring error 12.29 9.76 8 368566 5446 64124712
Therapeutic response decreased 12.24 9.76 217 368357 51971 64078187
Aggression 12.24 9.76 188 368386 46044 64084114
Pulmonary tuberculosis 12.22 9.76 14 368560 7230 64122928
Tendonitis 12.19 9.76 67 368507 20215 64109943
Bladder cancer 12.14 9.76 28 368546 10946 64119212
Shock haemorrhagic 12.10 9.76 52 368522 16739 64113419
Ascites 12.06 9.76 266 368308 61735 64068423
Bronchopulmonary aspergillosis 12.05 9.76 62 368512 19023 64111135
Metastases to central nervous system 12.03 9.76 40 368534 13872 64116286
Metastases to bone 12.01 9.76 68 368506 20367 64109791
Vitamin K deficiency 12.00 9.76 17 368557 662 64129496
Anticipatory anxiety 11.98 9.76 11 368563 264 64129894
Blood loss anaemia 11.97 9.76 40 368534 13852 64116306
Upper gastrointestinal haemorrhage 11.96 9.76 136 368438 35084 64095074
Stevens-Johnson syndrome 11.96 9.76 268 368306 33981 64096177
Activated partial thromboplastin time prolonged 11.95 9.76 119 368455 12712 64117446
Red cell distribution width decreased 11.95 9.76 22 368552 1071 64129087
Dyskinesia 11.90 9.76 156 368418 39232 64090926
Affective disorder 11.90 9.76 12 368562 6568 64123590
Traumatic liver injury 11.87 9.76 15 368559 522 64129636
Base excess 11.86 9.76 7 368567 82 64130076
Pancreatic carcinoma 11.85 9.76 26 368548 10347 64119811
Infusion site discomfort 11.83 9.76 18 368556 748 64129410
Lupus-like syndrome 11.82 9.76 20 368554 8771 64121387
Angiokeratoma 11.80 9.76 10 368564 215 64129943
Retinal haemorrhage 11.73 9.76 15 368559 7383 64122775
Skin burning sensation 11.70 9.76 27 368547 10556 64119602
Large intestine polyp 11.70 9.76 28 368546 10809 64119349
Obstructive airways disorder 11.64 9.76 81 368493 23104 64107054
Graft versus host disease in gastrointestinal tract 11.63 9.76 9 368565 5603 64124555
Fear of injection 11.61 9.76 10 368564 5902 64124256
Urine oxalate increased 11.61 9.76 10 368564 220 64129938
Ventricular extrasystoles 11.61 9.76 56 368518 17473 64112685
Bundle branch block left 11.59 9.76 25 368549 10009 64120149
Hypothyroidism 11.58 9.76 162 368412 40295 64089863
Diaphragmatic rupture 11.57 9.76 10 368564 221 64129937
Encephalopathy 11.56 9.76 428 368146 58391 64071767
Circulatory collapse 11.56 9.76 130 368444 33602 64096556
Autonomic dysreflexia 11.54 9.76 13 368561 400 64129758
Hypoglycaemic coma 11.49 9.76 5 368569 4269 64125889
Hypersensitivity vasculitis 11.48 9.76 13 368561 6748 64123410
Stent placement 11.47 9.76 9 368565 5562 64124596
Retinal deposits 11.43 9.76 8 368566 128 64130030
Carpal tunnel syndrome 11.42 9.76 49 368525 15779 64114379
Deafness 11.39 9.76 60 368514 18299 64111859
Application site pain 11.38 9.76 5 368569 4243 64125915
Potentiating drug interaction 11.37 9.76 17 368557 7835 64122323
Cerebral ischaemia 11.36 9.76 25 368549 9937 64120221
Prothrombin time shortened 11.35 9.76 39 368535 2810 64127348
Coagulation factor X level decreased 11.31 9.76 7 368567 90 64130068
Oral pruritus 11.29 9.76 29 368545 1776 64128382
Vessel puncture site bruise 11.26 9.76 13 368561 411 64129747
Leukocytosis 11.26 9.76 289 368285 37451 64092707
Peripheral arterial occlusive disease 11.26 9.76 14 368560 6973 64123185
Urine ketone body present 11.25 9.76 43 368531 3264 64126894
Paradoxical drug reaction 11.25 9.76 11 368563 6109 64124049
Polydipsia 11.25 9.76 10 368564 5811 64124347
Immunodeficiency 11.13 9.76 141 368433 15983 64114175
Post procedural pulmonary embolism 11.06 9.76 10 368564 235 64129923
Intraocular pressure increased 11.06 9.76 19 368555 8283 64121875
Impaired work ability 11.05 9.76 47 368527 15172 64114986
Acid-base balance disorder mixed 11.05 9.76 7 368567 94 64130064
pH urine increased 11.02 9.76 13 368561 421 64129737
Hernia 11.01 9.76 122 368452 13396 64116762
Gastritis erosive 11.00 9.76 24 368550 9571 64120587
Vital capacity decreased 11.00 9.76 21 368553 1051 64129107
Long QT syndrome 10.96 9.76 8 368566 5131 64125027
Dystonia 10.96 9.76 63 368511 18802 64111356
Cardiovascular disorder 10.95 9.76 50 368524 15831 64114327
Obsessive-compulsive disorder 10.95 9.76 7 368567 4811 64125347
Flatulence 10.87 9.76 141 368433 35525 64094633
Antipsychotic drug level increased 10.86 9.76 8 368566 5107 64125051
Myelocyte percentage increased 10.85 9.76 10 368564 241 64129917
Ketoacidosis 10.80 9.76 14 368560 6849 64123309
Emotional distress 10.79 9.76 143 368431 35895 64094263
Drug level above therapeutic 10.78 9.76 72 368502 6829 64123329
Acute graft versus host disease in skin 10.77 9.76 14 368560 6841 64123317
Kidney transplant rejection 10.73 9.76 24 368550 9487 64120671
Device failure 10.73 9.76 10 368564 5682 64124476
Hallucination, auditory 10.71 9.76 55 368519 16884 64113274
Torsade de pointes 10.63 9.76 57 368517 17306 64112852
Anal fissure 10.61 9.76 56 368518 4880 64125278
JC virus infection 10.61 9.76 3 368571 3352 64126806
Drug eruption 10.59 9.76 144 368430 35992 64094166
Dermatitis 10.59 9.76 60 368514 17969 64112189
Drug use disorder 10.59 9.76 65 368509 5989 64124169
Therapy non-responder 10.57 9.76 291 368283 65608 64064550
Blood bicarbonate decreased 10.53 9.76 55 368519 4774 64125384
Dysphonia 10.52 9.76 194 368380 46188 64083970
Oral discomfort 10.51 9.76 20 368554 8386 64121772
Allergy to plants 10.49 9.76 15 368559 589 64129569
Tardive dyskinesia 10.49 9.76 23 368551 9155 64121003
Red blood cell elliptocytes present 10.45 9.76 8 368566 148 64130010
Balance disorder 10.44 9.76 583 367991 83343 64046815
Ammonia increased 10.43 9.76 72 368502 6905 64123253
Eczema 10.40 9.76 114 368460 29606 64100552
Impaired quality of life 10.39 9.76 13 368561 6458 64123700
Nephrogenic systemic fibrosis 10.37 9.76 11 368563 5881 64124277
Necrotising oesophagitis 10.35 9.76 16 368558 674 64129484
Body height decreased 10.33 9.76 17 368557 7537 64122621
Administration site swelling 10.31 9.76 11 368563 318 64129840
Pneumonia cytomegaloviral 10.28 9.76 6 368568 4333 64125825
Inflammation 10.27 9.76 464 368110 64836 64065322
Sensitivity to weather change 10.25 9.76 14 368560 6700 64123458
Human herpesvirus 6 infection 10.25 9.76 7 368567 4647 64125511
Nail bed inflammation 10.24 9.76 14 368560 527 64129631
Coeliac disease 10.21 9.76 75 368499 7337 64122821
Spinal operation 10.19 9.76 12 368562 6121 64124037
Carbon monoxide poisoning 10.17 9.76 10 368564 262 64129896
Band neutrophil percentage increased 10.14 9.76 12 368562 390 64129768
Nose deformity 10.14 9.76 8 368566 155 64130003
Uterine perforation 10.09 9.76 11 368563 5809 64124349
Failure to suspend medication 10.06 9.76 12 368562 393 64129765
Malignant melanoma 10.06 9.76 39 368535 12925 64117233
Melaena 10.06 9.76 231 368343 53317 64076841
Intestinal haemorrhage 10.03 9.76 10 368564 5504 64124654
Adenocarcinoma of colon 10.01 9.76 8 368566 4900 64125258
Limb discomfort 10.01 9.76 103 368471 27072 64103086
Renal disorder 9.99 9.76 142 368432 35223 64094935
Ductus arteriosus stenosis foetal 9.97 9.76 6 368568 73 64130085
Hepatic cancer 9.96 9.76 17 368557 7431 64122727
Cerebral artery thrombosis 9.96 9.76 20 368554 1039 64129119
Aortic valve stenosis 9.94 9.76 7 368567 4573 64125585
Respiratory tract congestion 9.93 9.76 53 368521 16112 64114046
Product complaint 9.91 9.76 35 368539 11919 64118239
Pulmonary fibrosis 9.90 9.76 116 368458 29762 64100396
Pharyngitis streptococcal 9.90 9.76 84 368490 8584 64121574
Chronic gastrointestinal bleeding 9.88 9.76 12 368562 401 64129757
BK virus infection 9.84 9.76 17 368557 7395 64122763
Thoracic vertebral fracture 9.83 9.76 7 368567 4546 64125612
Dysstasia 9.83 9.76 85 368489 23130 64107028
Respiratory failure 9.83 9.76 790 367784 160393 63969765
Magnesium deficiency 9.81 9.76 14 368560 549 64129609
Sudden infant death syndrome 9.80 9.76 8 368566 163 64129995
Laboratory test abnormal 9.79 9.76 89 368485 23974 64106184
Dermatitis acneiform 9.78 9.76 21 368553 8422 64121736

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R06AA09 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
ATC R06AA59 RESPIRATORY SYSTEM
ANTIHISTAMINES FOR SYSTEMIC USE
ANTIHISTAMINES FOR SYSTEMIC USE
Aminoalkyl ethers
FDA MoA N0000000207 Histamine Receptor Antagonists
MeSH PA D018494 Histamine Agents
MeSH PA D006633 Histamine Antagonists
MeSH PA D006634 Histamine H1 Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D000932 Antiemetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA EPC N0000175750 Antihistamine
CHEBI has role CHEBI:35717 hypnotics
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:37956 antihistamines
CHEBI has role CHEBI:48873 acetylcholine receptor antagonist
CHEBI has role CHEBI:50857 anti-allergic drugs
CHEBI has role CHEBI:50919 antiemetico
CHEBI has role CHEBI:51177 anti-tussive

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Dermatographic urticaria indication 7632005 DOID:743
Vasomotor rhinitis indication 8229003 DOID:4730
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Sneezing indication 76067001
Common cold indication 82272006 DOID:10459
Urticaria indication 126485001
Influenza-like symptoms indication 315642008
Seasonal allergic rhinitis indication 367498001
Itching of skin indication 418363000
Allergic conjunctivitis indication 473460002 DOID:11204
Morning sickness off-label use 51885006
Ocular hypertension contraindication 4210003 DOID:9282
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Myocardial infarction contraindication 22298006 DOID:5844
Ventricular tachycardia contraindication 25569003
Hyperthyroidism contraindication 34486009 DOID:7998
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Acidosis contraindication 51387008
Coronary arteriosclerosis contraindication 53741008 DOID:3393
Hepatic failure contraindication 59927004
Arterial thrombosis contraindication 65198009
Poisoning by acetaminophen contraindication 70273001
Arteriosclerotic vascular disease contraindication 72092001
Diabetes mellitus contraindication 73211009 DOID:9351
Chronic idiopathic constipation contraindication 82934008
Partial atrioventricular block contraindication 195039008
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Benign prostatic hyperplasia contraindication 266569009
Retention of urine contraindication 267064002
Hypoxia contraindication 389086002
Angle-closure glaucoma contraindication 392291006 DOID:13550
Disorder of coronary artery contraindication 414024009
Hypertensive urgency contraindication 443482000




🐶 Veterinary Drug Use

SpeciesUseRelation
Cats Antihistaminic therapy Indication
Dogs Antihistaminic therapy Indication
Horses Antihistaminic therapy Indication

🐶 Veterinary products

ProductApplicantIngredients
A-H-Tablets 100 mg, A-H-Tablets 25 mg Intervet Inc. 1
A-H Injection Intervet Inc. 2

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.83 Basic
pKa2 4.29 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9089489 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9375404 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9526703 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
20MG;20MG BONJESTA DUCHESNAY N209661 Nov. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9937132 Feb. 18, 2033 TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Histamine H1 receptor GPCR ANTAGONIST CHEMBL CHEMBL

External reference:

IDSource
4019738 VUID
N0000147830 NUI
D02327 KEGG_DRUG
562-10-7 SECONDARY_CAS_RN
4019049 VANDF
4019738 VANDF
C0013092 UMLSCUI
CHEBI:51380 CHEBI
CHEMBL1004 ChEMBL_ID
CHEMBL1200392 ChEMBL_ID
DB00366 DRUGBANK_ID
D004319 MESH_DESCRIPTOR_UI
C035385 MESH_SUPPLEMENTAL_RECORD_UI
3162 PUBCHEM_CID
7171 IUPHAR_LIGAND_ID
1782 INN_ID
95QB77JKPL UNII
23665 RXNORM
10000 MMSL
4644 MMSL
d03154 MMSL
003372 NDDF
004789 NDDF
412380009 SNOMEDCT_US
44068004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Robitussin Maximum Strength Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8718 SOLUTION 12.50 mg ORAL OTC monograph final 17 sections
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime HUMAN OTC DRUG LABEL 3 0031-8744 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC MONOGRAPH FINAL 17 sections
Robitussin Honey Maximum Strength Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8758 SOLUTION 12.50 mg ORAL OTC monograph final 17 sections
Childrens Robitussin Honey Nighttime Cough DM HUMAN OTC DRUG LABEL 2 0031-8762 SOLUTION 6.25 mg ORAL OTC monograph final 17 sections
Good Sense Severe NightTime HUMAN OTC DRUG LABEL 4 0113-0019 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Good Sense Severe NightTime HUMAN OTC DRUG LABEL 4 0113-0019 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
good sense night time HUMAN OTC DRUG LABEL 3 0113-0056 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC monograph final 15 sections
good sense night time HUMAN OTC DRUG LABEL 3 0113-0335 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Good sense sleep aid HUMAN OTC DRUG LABEL 1 0113-0441 TABLET 25 mg ORAL ANDA 16 sections
good sense nighttime HUMAN OTC DRUG LABEL 3 0113-0459 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Good Sense Nighttime Cough HUMAN OTC DRUG LABEL 2 0113-0668 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Good Sense Severe NightTime Cold and Flu HUMAN OTC DRUG LABEL 4 0113-0763 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Good Sense Severe NightTime Cold and Flu HUMAN OTC DRUG LABEL 4 0113-0763 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Basic Care Nighttime Cold and Flu HUMAN OTC DRUG LABEL 3 0113-7056 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC monograph final 16 sections
basic care nighttime cold and flu HUMAN OTC DRUG LABEL 3 0113-7335 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
basic care sleep aid HUMAN OTC DRUG LABEL 1 0113-7441 TABLET 25 mg ORAL ANDA 16 sections
Basic Care Nighttime HUMAN OTC DRUG LABEL 3 0113-7459 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
basic care nighttime cold and flu HUMAN OTC DRUG LABEL 4 0113-7501 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
basic care nighttime cold and flu severe HUMAN OTC DRUG LABEL 4 0113-7763 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold Powerfast Fizz Night HUMAN OTC DRUG LABEL 4 0280-0021 TABLET, EFFERVESCENT 6.25 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Severe Cold Night PowerFast Fizz HUMAN OTC DRUG LABEL 4 0280-0068 TABLET, EFFERVESCENT 6.25 mg ORAL OTC monograph final 16 sections
Alka-Seltzer Plus Night Severe Cold and Flu HUMAN OTC DRUG LABEL 4 0280-0922 POWDER, FOR SOLUTION 12.50 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Cold Night HUMAN OTC DRUG LABEL 4 0280-1545 TABLET, EFFERVESCENT 6.25 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Maximum Strength Night Cold and Flu HUMAN OTC DRUG LABEL 4 0280-1600 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough HUMAN OTC DRUG LABEL 4 0280-1620 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC monograph final 17 sections
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels HUMAN OTC DRUG LABEL 4 0280-1640 CAPSULE, LIQUID FILLED 6.25 mg ORAL OTC monograph final 17 sections
SafetussinPM HUMAN OTC DRUG LABEL 2 0295-5307 LIQUID 3.13 mg ORAL OTC monograph final 13 sections
Cough HUMAN OTC DRUG LABEL 2 0363-0019 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections
Night Time Severe Cold and Flu HUMAN OTC DRUG LABEL 4 0363-0331 LIQUID 12.50 mg ORAL OTC monograph final 16 sections
Cold and Flu HUMAN OTC DRUG LABEL 3 0363-0401 SOLUTION 12.50 mg ORAL OTC monograph final 16 sections