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

Stem definitionDrug idCAS RN
4196 68-19-9

Description:

MoleculeDescription

Synonyms:

  • cyanocobalamin
  • vitamin B12
  • cobamin
  • cyanocobalamine
  • Molecular weight: 1355.39
  • Formula: C63H88CoN14O14P
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 512.50
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
70 mcg N
1 mg O
20 mcg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 12.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.42 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Sept. 15, 1949 FDA

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
Pemphigus 1131.57 10.27 3083 476161 117083 50008797
Systemic lupus erythematosus 1049.57 10.27 3321 475923 137301 49988579
Completed suicide 934.32 10.27 86 479158 131803 49994077
Glossodynia 904.23 10.27 2775 476469 112794 50013086
Toxicity to various agents 747.32 10.27 553 478691 211946 49913934
Rheumatoid arthritis 718.96 10.27 3799 475445 198751 49927129
Hand deformity 692.46 10.27 2306 476938 97893 50027987
Alopecia 673.75 10.27 4295 474949 240752 49885128
Abdominal discomfort 661.64 10.27 4100 475144 227541 49898339
Arthropathy 633.30 10.27 3066 476178 154840 49971040
Maternal exposure during pregnancy 579.78 10.27 3016 476228 156762 49969118
Wound 568.19 10.27 2243 477001 103551 50022329
Infusion related reaction 451.27 10.27 2949 476295 166608 49959272
Drug interaction 442.91 10.27 756 478488 198865 49927015
Pericarditis 423.65 10.27 1670 477574 77019 50048861
Drug abuse 413.16 10.27 43 479201 59803 50066077
Anti-cyclic citrullinated peptide antibody positive 411.12 10.27 1536 477708 69051 50056829
Discomfort 409.64 10.27 2070 477174 106310 50019570
Synovitis 408.90 10.27 2279 476965 121586 50004294
Pain 401.75 10.27 7696 471548 571207 49554673
Death 370.54 10.27 1703 477541 323676 49802204
Swelling 370.43 10.27 3204 476040 197668 49928212
Intentional overdose 368.53 10.27 72 479172 62432 50063448
Contraindicated product administered 339.61 10.27 2495 476749 146463 49979417
Joint swelling 333.36 10.27 3670 475574 241616 49884264
Arthralgia 273.63 10.27 5743 473501 432959 49692921
Overdose 266.79 10.27 331 478913 99396 50026484
Product use issue 262.77 10.27 2360 476884 147115 49978765
Rheumatoid factor positive 248.99 10.27 1034 478210 48825 50077055
Duodenal ulcer perforation 230.98 10.27 950 478294 44661 50081219
Suicide attempt 229.58 10.27 101 479143 51631 50074249
Helicobacter infection 226.81 10.27 1003 478241 48699 50077181
Febrile neutropenia 226.51 10.27 359 478885 97308 50028572
Drug hypersensitivity 220.30 10.27 1432 477812 249578 49876302
Cardiac arrest 208.03 10.27 293 478951 83358 50042522
Acute kidney injury 204.20 10.27 1293 477951 226765 49899115
Fatigue 187.32 10.27 8334 470910 699267 49426613
Hepatic enzyme increased 183.72 10.27 2050 477194 135330 49990550
Depressed level of consciousness 181.27 10.27 136 479108 51817 50074063
Nasopharyngitis 179.58 10.27 2693 476551 190234 49935646
Musculoskeletal stiffness 171.69 10.27 1917 477327 126564 49999316
Hip arthroplasty 170.30 10.27 654 478590 29775 50096105
Malignant neoplasm progression 169.99 10.27 238 479006 67886 50057994
Psoriatic arthropathy 159.41 10.27 872 478372 46160 50079720
Knee arthroplasty 157.22 10.27 715 478529 35131 50090749
Electrocardiogram QT prolonged 156.51 10.27 156 479088 51730 50074150
Exposure during pregnancy 145.37 10.27 1769 477475 119246 50006634
Device expulsion 143.33 10.27 47 479197 28775 50097105
Lactic acidosis 138.96 10.27 71 479173 33284 50092596
Hyponatraemia 134.58 10.27 463 478781 95676 50030204
Neutropenia 133.81 10.27 836 478408 147129 49978751
Cardiac failure 132.77 10.27 330 478914 75710 50050170
Hypotension 132.18 10.27 1509 477735 233960 49891920
Drug reaction with eosinophilia and systemic symptoms 130.10 10.27 53 479191 28371 50097509
Bradycardia 128.48 10.27 260 478984 64166 50061714
Disease progression 124.08 10.27 477 478767 95389 50030491
Cardio-respiratory arrest 119.40 10.27 204 479040 53688 50072192
Sedation 119.05 10.27 71 479173 30539 50095341
Respiratory arrest 116.16 10.27 70 479174 29939 50095941
Therapeutic product effect decreased 115.39 10.27 1870 477374 134180 49991700
Rhabdomyolysis 113.55 10.27 121 479123 38906 50086974
Red blood cell sedimentation rate abnormal 110.80 10.27 374 478870 15969 50109911
Intentional self-injury 107.57 10.27 42 479202 23070 50102810
Sopor 106.93 10.27 28 479216 19851 50106029
Psoriasis 106.89 10.27 1061 478183 67939 50057941
Drug intolerance 103.99 10.27 2764 476480 216340 49909540
Agitation 103.43 10.27 219 479025 53165 50072715
Vomiting 101.39 10.27 3461 475783 457297 49668583
Sickle cell anaemia with crisis 101.18 10.27 166 479078 4377 50121503
Treatment failure 100.17 10.27 1846 477398 135791 49990089
Renal failure 98.17 10.27 599 478645 106034 50019846
Serotonin syndrome 93.77 10.27 59 479185 24654 50101226
Tachycardia 93.63 10.27 557 478687 99206 50026674
Hepatic failure 92.91 10.27 101 479143 32182 50093698
Rheumatic fever 90.69 10.27 358 478886 16509 50109371
C-reactive protein abnormal 88.50 10.27 507 478737 27302 50098578
Swollen joint count increased 88.46 10.27 326 478918 14547 50111333
Multiple organ dysfunction syndrome 88.21 10.27 218 479026 50119 50075761
Arthritis 87.05 10.27 1227 478017 85494 50040386
Metabolic acidosis 86.89 10.27 146 479098 38679 50087201
Respiratory failure 84.55 10.27 511 478733 90670 50035210
Hypersensitivity 84.37 10.27 2650 476594 212511 49913369
Hepatic function abnormal 83.70 10.27 112 479132 32569 50093311
Dyspnoea 79.91 10.27 4307 474937 543301 49582579
Impaired healing 79.38 10.27 1010 478234 68776 50057104
Drug resistance 78.24 10.27 41 479203 18948 50106932
Cholestasis 77.01 10.27 76 479168 25325 50100555
Blood pressure fluctuation 75.26 10.27 589 478655 35234 50090646
Thrombocytopenia 75.18 10.27 809 478435 126864 49999016
Osteoarthritis 74.70 10.27 985 478259 67621 50058259
Hypoglycaemia 74.31 10.27 259 478985 53322 50072558
Coma 72.94 10.27 284 478960 56595 50069285
Nausea 71.69 10.27 5732 473512 699666 49426214
Hepatocellular injury 69.46 10.27 86 479158 25861 50100019
Drug dependence 68.56 10.27 52 479192 19707 50106173
Renal impairment 68.07 10.27 428 478816 75233 50050647
Hyperglycaemia 67.50 10.27 153 479091 36252 50089628
Drug withdrawal syndrome 67.28 10.27 83 479161 24998 50100882
Encephalopathy 67.24 10.27 136 479108 33575 50092305
Somnolence 65.91 10.27 1051 478193 153934 49971946
Pregnancy 65.87 10.27 493 478751 29084 50096796
Peripheral swelling 65.52 10.27 2476 476768 203460 49922420
Sedation complication 63.98 10.27 5 479239 8761 50117119
Cytomegalovirus infection 63.96 10.27 46 479198 17916 50107964
Rash 61.73 10.27 4875 474369 432596 49693284
Hypoxia 61.32 10.27 262 478982 50861 50075019
Palmar-plantar erythrodysaesthesia syndrome 61.09 10.27 60 479184 20038 50105842
Sinusitis 60.71 10.27 2077 477167 168481 49957399
Anaphylactic reaction 60.64 10.27 284 478960 53771 50072109
Poisoning 60.52 10.27 21 479223 12408 50113472
Injection site erythema 60.15 10.27 1021 478223 73915 50051965
Live birth 59.51 10.27 310 478934 16098 50109782
Leukopenia 58.19 10.27 387 478857 67141 50058739
Seizure 57.89 10.27 777 478467 117097 50008783
Respiratory depression 57.27 10.27 21 479223 11989 50113891
Mydriasis 57.10 10.27 15 479229 10612 50115268
Anaemia 56.82 10.27 1890 477354 250566 49875314
Cardiac failure congestive 56.63 10.27 518 478726 83864 50042016
Fibromyalgia 56.35 10.27 663 478581 44315 50081565
Sleep disorder due to general medical condition, insomnia type 55.90 10.27 498 478746 30949 50094931
Shock 55.75 10.27 68 479176 20582 50105298
Hyperkalaemia 54.92 10.27 251 478993 47838 50078042
Myalgia 54.88 10.27 837 478407 123482 50002398
Product use in unapproved indication 54.88 10.27 769 478475 115050 50010830
Angioedema 54.36 10.27 179 479065 37497 50088383
Contusion 54.22 10.27 1419 477825 110764 50015116
Acute hepatic failure 53.45 10.27 42 479202 15635 50110245
No adverse event 53.09 10.27 153 479091 33425 50092455
Basal cell carcinoma 51.83 10.27 389 478855 22967 50102913
Injection site pruritus 51.66 10.27 598 478646 39813 50086067
Abortion spontaneous 51.56 10.27 614 478630 41158 50084722
Joint effusion 51.44 10.27 252 478992 12769 50113111
Delirium 51.36 10.27 187 479057 38005 50087875
Syncope 50.92 10.27 678 478566 102324 50023556
Urticaria 50.69 10.27 892 478352 128669 49997211
Ejection fraction decreased 49.98 10.27 61 479183 18459 50107421
Metastases to bone 49.92 10.27 58 479186 17937 50107943
Posterior reversible encephalopathy syndrome 49.63 10.27 41 479203 14887 50110993
Intentional product misuse 49.26 10.27 251 478993 46483 50079397
Blood glucose increased 49.10 10.27 435 478809 70889 50054991
Osteonecrosis of jaw 48.70 10.27 152 479092 32374 50093506
Respiratory disorder 48.65 10.27 143 479101 31044 50094836
Creatinine renal clearance decreased 48.43 10.27 26 479218 11855 50114025
Disability assessment scale score increased 48.30 10.27 83 479161 2275 50123605
Hyperhidrosis 48.17 10.27 578 478666 88848 50037032
Hypokalaemia 48.06 10.27 567 478677 87425 50038455
Hypothermia 47.96 10.27 27 479217 11989 50113891
Lower respiratory tract infection 47.69 10.27 1210 478034 93991 50031889
Orthostatic hypotension 47.59 10.27 133 479111 29348 50096532
Juvenile idiopathic arthritis 47.16 10.27 92 479152 2787 50123093
Torsade de pointes 46.66 10.27 27 479217 11808 50114072
Altered state of consciousness 46.65 10.27 85 479159 21825 50104055
Unresponsive to stimuli 46.56 10.27 142 479102 30467 50095413
Blood creatine phosphokinase increased 46.34 10.27 114 479130 26253 50099627
Accidental overdose 46.01 10.27 71 479173 19462 50106418
Loss of personal independence in daily activities 45.96 10.27 925 478319 69125 50056755
Condition aggravated 45.76 10.27 3334 475910 293724 49832156
Muscle injury 45.59 10.27 545 478699 36566 50089314
Folliculitis 45.57 10.27 570 478674 38655 50087225
Carpal tunnel syndrome 44.91 10.27 294 478950 16599 50109281
Drug level increased 44.47 10.27 71 479173 19197 50106683
Neuroleptic malignant syndrome 44.44 10.27 25 479219 11105 50114775
Ascites 44.11 10.27 182 479062 35679 50090201
Blood alkaline phosphatase increased 43.97 10.27 194 479050 37332 50088548
Neoplasm progression 43.83 10.27 136 479108 29021 50096859
Product quality issue 43.57 10.27 148 479096 30710 50095170
Blister 43.18 10.27 1087 478157 84331 50041549
International normalised ratio increased 43.12 10.27 236 479008 42916 50082964
Myocardial infarction 42.92 10.27 589 478655 88438 50037442
Gamma-glutamyltransferase increased 42.56 10.27 141 479103 29482 50096398
Aspartate aminotransferase increased 42.44 10.27 503 478741 77495 50048385
Pulmonary embolism 42.44 10.27 692 478552 101012 50024868
Weight increased 42.28 10.27 2327 476917 199564 49926316
Injection site pain 42.28 10.27 1363 477881 109661 50016219
Joint laxity 42.20 10.27 79 479165 2319 50123561
Constipation 42.05 10.27 1389 477855 184319 49941561
Metastases to liver 41.91 10.27 79 479165 20025 50105855
Anxiety 41.74 10.27 1322 477922 176284 49949596
Osteoporosis 41.46 10.27 626 478618 44253 50081627
Grip strength decreased 41.23 10.27 225 479019 11896 50113984
Diarrhoea 41.19 10.27 4913 474331 583563 49542317
Oropharyngeal pain 41.10 10.27 996 478248 76805 50049075
Injection site swelling 41.07 10.27 589 478655 41184 50084696
Cognitive disorder 41.03 10.27 247 478997 43876 50082004
Caesarean section 40.86 10.27 271 478973 15368 50110512
Injection site reaction 40.62 10.27 683 478561 49349 50076531
Coagulopathy 40.59 10.27 67 479177 17877 50108003
Pulmonary arterial hypertension 40.49 10.27 82 479162 20237 50105643
Alanine aminotransferase increased 40.33 10.27 591 478653 87768 50038112
Respiratory distress 39.87 10.27 151 479093 30338 50095542
Disseminated intravascular coagulation 39.68 10.27 63 479181 17072 50108808
Anaphylactic shock 39.61 10.27 82 479162 20073 50105807
Transplant rejection 39.21 10.27 21 479223 9588 50116292
Tremor 39.12 10.27 810 478434 114093 50011787
Sepsis 38.76 10.27 960 478284 131965 49993915
Mental status changes 38.69 10.27 194 479050 36078 50089802
Blood bilirubin increased 38.53 10.27 164 479080 31874 50094006
Pleural effusion 38.51 10.27 541 478703 80913 50044967
Heart rate decreased 38.47 10.27 521 478723 35976 50089904
Pyrexia 38.33 10.27 3090 476154 377113 49748767
Pain in extremity 38.09 10.27 3039 476205 269826 49856054
Carotid artery thrombosis 37.83 10.27 58 479186 1441 50124439
Irritable bowel syndrome 37.74 10.27 691 478553 50750 50075130
Hepatotoxicity 37.48 10.27 132 479112 27094 50098786
Infective pulmonary exacerbation of cystic fibrosis 37.43 10.27 14 479230 7895 50117985
Agranulocytosis 37.34 10.27 93 479151 21328 50104552
Foot deformity 37.17 10.27 310 478934 18900 50106980
Disorientation 37.16 10.27 191 479053 35293 50090587
Akathisia 36.60 10.27 16 479228 8213 50117667
Intentional product use issue 36.59 10.27 971 478273 75947 50049933
Neurologic neglect syndrome 36.22 10.27 56 479188 1402 50124478
Blood cholesterol increased 36.18 10.27 729 478515 54486 50071394
Toxic skin eruption 36.06 10.27 32 479212 11219 50114661
Ventricular tachycardia 35.85 10.27 59 479185 15762 50110118
Jaundice 35.80 10.27 129 479115 26300 50099580
Diabetic ketoacidosis 35.72 10.27 72 479172 17800 50108080
Product administration error 35.54 10.27 84 479160 19615 50106265
Off label use 35.44 10.27 3943 475301 470483 49655397
Cerebral haemorrhage 35.36 10.27 134 479110 26918 50098962
Blood pressure systolic increased 35.32 10.27 501 478743 34948 50090932
Neurotoxicity 35.27 10.27 53 479191 14687 50111193
Loss of consciousness 35.12 10.27 737 478507 103616 50022264
Suicidal ideation 35.02 10.27 345 478899 55040 50070840
Disturbance in attention 34.88 10.27 164 479080 31022 50094858
Extrapyramidal disorder 34.78 10.27 36 479208 11734 50114146
Speech disorder 34.65 10.27 196 479048 35352 50090528
Neck deformity 34.60 10.27 65 479179 1913 50123967
Cardiogenic shock 34.58 10.27 59 479185 15540 50110340
Arrhythmia 34.32 10.27 179 479065 32953 50092927
Brain oedema 34.17 10.27 40 479204 12330 50113550
Blood pressure diastolic abnormal 34.04 10.27 177 479067 9184 50116696
Febrile bone marrow aplasia 33.73 10.27 9 479235 6302 50119578
Adjustment disorder 33.66 10.27 65 479179 1954 50123926
Thrombotic microangiopathy 33.33 10.27 21 479223 8770 50117110
Multiple fractures 32.90 10.27 137 479107 6474 50119406
Sensitisation 32.82 10.27 56 479188 1526 50124354
Unintentional medical device removal 32.58 10.27 6 479238 5429 50120451
Graft versus host disease 32.57 10.27 9 479235 6157 50119723
Asphyxia 32.51 10.27 6 479238 5421 50120459
Pancreatitis acute 32.41 10.27 116 479128 23696 50102184
Dizziness 32.33 10.27 2832 476412 343537 49782343
Red blood cell sedimentation rate increased 32.28 10.27 423 478821 28993 50096887
Abnormal behaviour 32.24 10.27 88 479156 19570 50106310
Schizophrenia 31.94 10.27 15 479229 7382 50118498
Emotional distress 31.90 10.27 151 479093 28512 50097368
Mania 31.57 10.27 34 479210 10882 50114998
Neutrophil count decreased 31.54 10.27 281 478963 45745 50080135
Ventricular septal defect 31.49 10.27 97 479147 3944 50121936
Obstructive airways disorder 31.33 10.27 63 479181 15589 50110291
Psychotic disorder 31.21 10.27 104 479140 21708 50104172
Femur fracture 30.98 10.27 513 478731 36951 50088929
Wrong technique in product usage process 30.96 10.27 356 478888 55154 50070726
Polyneuropathy 30.63 10.27 42 479202 12089 50113791
Injection site bruising 30.60 10.27 504 478740 36264 50089616
Ill-defined disorder 30.48 10.27 705 478539 53949 50071931
Sinus tachycardia 30.43 10.27 102 479142 21252 50104628
Acute generalised exanthematous pustulosis 30.40 10.27 24 479220 8914 50116966
Skin cancer 30.37 10.27 172 479072 9222 50116658
Miosis 30.14 10.27 11 479233 6299 50119581
Haemorrhage 29.70 10.27 343 478901 53098 50072782
Blood pressure systolic abnormal 29.63 10.27 148 479096 7558 50118322
Metastases to central nervous system 29.57 10.27 38 479206 11244 50114636
Premature labour 29.46 10.27 198 479046 11278 50114602
Status epilepticus 29.45 10.27 51 479193 13355 50112525
Myoclonus 29.17 10.27 58 479186 14412 50111468
Tumour lysis syndrome 29.15 10.27 17 479227 7404 50118476
Gestational diabetes 29.15 10.27 144 479100 7321 50118559
Acute myeloid leukaemia 29.05 10.27 62 479182 15012 50110868
Localised infection 29.03 10.27 369 478875 25116 50100764
Ischaemic stroke 28.78 10.27 68 479176 15880 50110000
Rash maculo-papular 28.69 10.27 142 479102 26499 50099381
Chest discomfort 28.58 10.27 664 478580 92058 50033822
Parkinsonism 28.55 10.27 25 479219 8822 50117058
Pancreatitis 28.40 10.27 262 478982 42352 50083528
Pain in jaw 28.40 10.27 230 479014 38198 50087682
Haematotoxicity 28.40 10.27 20 479224 7875 50118005
Stress cardiomyopathy 28.34 10.27 20 479224 7867 50118013
Maternal drugs affecting foetus 28.30 10.27 109 479135 4968 50120912
Ejection fraction 28.29 10.27 45 479199 1155 50124725
Enthesopathy 28.26 10.27 139 479105 7054 50118826
Ventricular fibrillation 28.26 10.27 35 479209 10524 50115356
Proteinuria 28.20 10.27 73 479171 16524 50109356
Insomnia 28.09 10.27 1361 477883 173504 49952376
Tachypnoea 28.06 10.27 60 479184 14517 50111363
Device dislocation 27.99 10.27 107 479137 21439 50104441
Blood pressure diastolic decreased 27.92 10.27 262 478982 16519 50109361
Deep vein thrombosis 27.92 10.27 507 478737 72797 50053083
Fear 27.91 10.27 60 479184 14489 50111391
Intestinal stenosis 27.77 10.27 69 479175 2471 50123409
Gastroenteritis viral 27.69 10.27 286 478958 18500 50107380
Bone marrow failure 27.64 10.27 151 479093 27473 50098407
Blood calcium decreased 27.43 10.27 102 479142 20604 50105276
Device difficult to use 27.27 10.27 32 479212 9854 50116026
Haemoptysis 27.14 10.27 137 479107 25436 50100444
Accidental exposure to product 27.13 10.27 119 479125 22938 50102942
Inappropriate antidiuretic hormone secretion 27.09 10.27 52 479192 13091 50112789
Stevens-Johnson syndrome 27.00 10.27 110 479134 21642 50104238
Hypomagnesaemia 26.95 10.27 120 479124 23036 50102844
Drug ineffective for unapproved indication 26.80 10.27 107 479137 21174 50104706
Melaena 26.79 10.27 147 479097 26717 50099163
Pulmonary hypertension 26.58 10.27 196 479048 33221 50092659
Dystonia 26.54 10.27 45 479199 11881 50113999
Uterine perforation 26.21 10.27 14 479230 6401 50119479
Bone erosion 26.13 10.27 195 479049 11492 50114388
Hallucination 26.11 10.27 299 478945 46358 50079522
Aggression 26.07 10.27 107 479137 21009 50104871
Forced expiratory volume decreased 26.02 10.27 5 479239 4389 50121491
Haemophagocytic lymphohistiocytosis 25.97 10.27 26 479218 8607 50117273
Influenza 25.95 10.27 1066 478178 88472 50037408
Drug ineffective 25.79 10.27 8395 470849 810938 49314942
Asthenia 25.72 10.27 2637 476607 316405 49809475
Injection site rash 25.64 10.27 250 478994 15927 50109953
Face oedema 25.56 10.27 85 479159 17754 50108126
Toxic epidermal necrolysis 25.53 10.27 107 479137 20885 50104995
Pulmonary oedema 25.33 10.27 319 478925 48619 50077261
Cholecystitis chronic 24.89 10.27 33 479211 9636 50116244
Cytokine release syndrome 24.85 10.27 27 479217 8607 50117273
Acute respiratory failure 24.76 10.27 165 479079 28617 50097263
Synovial cyst 24.76 10.27 147 479097 8019 50117861
Tuberculosis 24.72 10.27 172 479072 9911 50115969
Acute graft versus host disease 24.53 10.27 4 479240 3954 50121926
Drug-induced liver injury 24.20 10.27 161 479083 27934 50097946
Nodule 24.19 10.27 257 478987 16746 50109134
Metastases to lung 24.14 10.27 42 479202 10978 50114902
Disability 24.10 10.27 205 479039 12570 50113310
Fluid retention 24.08 10.27 336 478908 50313 50075567
Type 2 diabetes mellitus 23.91 10.27 458 478786 33917 50091963
Pre-eclampsia 23.87 10.27 144 479100 7900 50117980
Bronchopulmonary aspergillosis 23.85 10.27 22 479222 7570 50118310
Device use error 23.80 10.27 10 479234 5256 50120624
Substance abuse 23.78 10.27 5 479239 4119 50121761
Neck mass 23.74 10.27 78 479166 3283 50122597
Skin papilloma 23.74 10.27 91 479153 4138 50121742
Myopathy 23.72 10.27 31 479213 9108 50116772
Aspergillus infection 23.60 10.27 18 479226 6803 50119077
Polycystic ovaries 23.58 10.27 64 479180 2420 50123460
Maternal exposure before pregnancy 23.32 10.27 110 479134 5487 50120393
Myelosuppression 23.32 10.27 59 479185 13458 50112422
Rheumatoid nodule 23.31 10.27 203 479041 12532 50113348
Spinal stenosis 23.27 10.27 213 479031 13337 50112543
Genital haemorrhage 23.19 10.27 17 479227 6557 50119323
Complication associated with device 23 10.27 67 479177 14588 50111292
Tardive dyskinesia 22.98 10.27 21 479223 7258 50118622
Polyarthritis 22.95 10.27 141 479103 7786 50118094
Tenosynovitis stenosans 22.84 10.27 59 479185 2165 50123715
Foetal exposure during pregnancy 22.76 10.27 375 478869 26984 50098896
Anuria 22.73 10.27 45 479199 11199 50114681
Pharyngitis streptococcal 22.63 10.27 152 479092 8656 50117224
Joint destruction 22.59 10.27 85 479159 3831 50122049
Dyspnoea exertional 22.57 10.27 345 478899 50888 50074992
Decreased appetite 22.55 10.27 1618 477626 199305 49926575
Circulatory collapse 22.47 10.27 105 479139 19895 50105985
Withdrawal syndrome 22.43 10.27 88 479156 17502 50108378
Wheelchair user 22.41 10.27 100 479144 4872 50121008
Pathogen resistance 22.40 10.27 13 479231 5676 50120204
Limb deformity 22.33 10.27 82 479162 3652 50122228
Atrial fibrillation 22.30 10.27 764 478480 100981 50024899
Inflammation 22.25 10.27 701 478543 56211 50069669
Joint stiffness 21.83 10.27 406 478838 29902 50095978
Bronchospasm 21.82 10.27 70 479174 14784 50111096
Restlessness 21.81 10.27 144 479100 25029 50100851
Atrioventricular block complete 21.66 10.27 22 479222 7233 50118647
Surgery 21.55 10.27 404 478840 29801 50096079
Hepatic cytolysis 21.54 10.27 27 479217 8076 50117804
Tenderness 21.22 10.27 269 478975 18296 50107584
Pemphigoid 21.20 10.27 15 479229 5892 50119988
Small for dates baby 20.99 10.27 77 479167 3428 50122452
Blood creatinine increased 20.86 10.27 555 478689 75605 50050275
Temperature regulation disorder 20.83 10.27 7 479237 4220 50121660
Gastrointestinal haemorrhage 20.69 10.27 532 478712 72789 50053091
Body temperature decreased 20.67 10.27 242 479002 16153 50109727
Oedema 20.67 10.27 506 478738 69675 50056205
Smear cervix abnormal 20.62 10.27 65 479179 2676 50123204
Product complaint 20.60 10.27 49 479195 11417 50114463
Confusional state 20.58 10.27 1499 477745 184429 49941451
Premature rupture of membranes 20.55 10.27 92 479152 4488 50121392
Disease recurrence 20.51 10.27 109 479135 19972 50105908
Bradyphrenia 20.32 10.27 17 479227 6135 50119745
Erythema multiforme 20.27 10.27 34 479210 9016 50116864
Malignant melanoma 20.03 10.27 164 479080 9944 50115936
Incorrect route of product administration 19.81 10.27 100 479144 18566 50107314
Irritability 19.72 10.27 173 479071 28253 50097627
Musculoskeletal pain 19.71 10.27 854 478390 71323 50054557
Pseudomonas infection 19.71 10.27 37 479207 9393 50116487
Hypomania 19.66 10.27 9 479235 4496 50121384
Developmental hip dysplasia 19.64 10.27 40 479204 1251 50124629
Macular degeneration 19.64 10.27 70 479174 14318 50111562
Hypertransaminasaemia 19.59 10.27 5 479239 3606 50122274
Latent tuberculosis 19.53 10.27 56 479188 2187 50123693
Transplant dysfunction 19.46 10.27 10 479234 4674 50121206
Blood pressure diastolic increased 19.46 10.27 129 479115 7314 50118566
Blood pressure increased 19.40 10.27 1488 477756 131644 49994236
Arthritis infective 19.36 10.27 104 479140 5465 50120415
Red blood cell count decreased 19.35 10.27 438 478806 33397 50092483
Right aortic arch 19.24 10.27 17 479227 227 50125653
Laryngitis 19.21 10.27 173 479071 10783 50115097
Chronic kidney disease 19.20 10.27 263 478981 39508 50086372
Frequent bowel movements 19.16 10.27 209 479035 13709 50112171
Blood pressure decreased 19.05 10.27 394 478850 55515 50070365
Pulseless electrical activity 19.03 10.27 22 479222 6819 50119061
Poor venous access 19.02 10.27 165 479079 10175 50115705
Weight decreased 18.87 10.27 2382 476862 218863 49907017
Coronary artery disease 18.86 10.27 185 479059 29541 50096339
Dysmorphism 18.77 10.27 54 479190 2113 50123767
Eosinophilia 18.63 10.27 102 479142 18550 50107330
Cardiomyopathy 18.61 10.27 80 479164 15506 50110374
Septic shock 18.59 10.27 406 478838 56769 50069111
Haemorrhage intracranial 18.40 10.27 58 479186 12316 50113564
Ketoacidosis 18.25 10.27 7 479237 3888 50121992
Acidosis 18.14 10.27 44 479200 10183 50115697
Exposure to toxic agent 18.12 10.27 6 479238 3652 50122228
Rotator cuff repair 18.11 10.27 46 479198 1670 50124210
Herpes zoster 18.11 10.27 832 478412 69954 50055926
Cyanosis 18.09 10.27 78 479166 15106 50110774
Haematoma 18.07 10.27 193 479051 30317 50095563
Paradoxical drug reaction 18.04 10.27 6 479238 3641 50122239
Joint injury 17.88 10.27 298 478946 21491 50104389
Labelled drug-drug interaction medication error 17.86 10.27 46 479198 10431 50115449
Hypocalcaemia 17.81 10.27 165 479079 26651 50099229
Nightmare 17.75 10.27 85 479159 16001 50109879
Hyperprolactinaemia 17.61 10.27 5 479239 3360 50122520
Postoperative wound infection 17.60 10.27 139 479105 8336 50117544
Cerebral infarction 17.52 10.27 126 479118 21478 50104402
Bone pain 17.25 10.27 329 478915 46900 50078980
Atrial septal defect 17.25 10.27 111 479133 6230 50119650
Drug abuser 17.22 10.27 3 479241 2825 50123055
Leukocytosis 17.21 10.27 134 479110 22445 50103435
Drug use disorder 17.16 10.27 4 479240 3068 50122812
Intervertebral disc degeneration 17.11 10.27 199 479045 13262 50112618
Vitamin B12 deficiency 17.08 10.27 78 479166 3838 50122042
Cardiotoxicity 17.07 10.27 25 479219 7002 50118878
Catatonia 17.04 10.27 7 479237 3729 50122151
Dehydration 17.04 10.27 1228 478016 151221 49974659
Renal injury 16.95 10.27 35 479209 8576 50117304
Palpitations 16.89 10.27 727 478517 93779 50032101
Product substitution issue 16.88 10.27 72 479172 13985 50111895
Pulmonary haemorrhage 16.87 10.27 22 479222 6470 50119410
Placental disorder 16.87 10.27 40 479204 1390 50124490
Vertigo 16.87 10.27 368 478876 51464 50074416
Skin ulcer 16.83 10.27 446 478798 34872 50091008
Joint range of motion decreased 16.62 10.27 257 478987 18255 50107625
Pregnancy with contraceptive device 16.52 10.27 9 479235 4070 50121810
Pulmonary fibrosis 16.46 10.27 324 478920 24113 50101767
Synovial fluid analysis 16.35 10.27 43 479201 1595 50124285
Hospitalisation 16.34 10.27 504 478740 67433 50058447
Bundle branch block left 16.31 10.27 21 479223 6209 50119671
Polyhydramnios 16.15 10.27 49 479195 1976 50123904
Pulmonary alveolar haemorrhage 16.14 10.27 9 479235 4018 50121862
Squamous cell carcinoma 16.11 10.27 127 479117 7612 50118268
Acute coronary syndrome 16.10 10.27 41 479203 9333 50116547
Dermatitis exfoliative 16.03 10.27 15 479229 5127 50120753
Dermatitis bullous 16.02 10.27 27 479217 7146 50118734
Platelet count decreased 15.95 10.27 785 478459 99941 50025939
Acute myocardial infarction 15.83 10.27 189 479055 29084 50096796
Urinary retention 15.78 10.27 165 479079 26025 50099855
Psychomotor hyperactivity 15.73 10.27 41 479203 9260 50116620
Abortion incomplete 15.71 10.27 5 479239 3121 50122759
Loose body in joint 15.68 10.27 35 479209 1168 50124712
Hypervolaemia 15.63 10.27 160 479084 25339 50100541
Cytomegalovirus viraemia 15.57 10.27 13 479231 4696 50121184
Glycosylated haemoglobin increased 15.57 10.27 50 479194 10556 50115324
Shock haemorrhagic 15.52 10.27 35 479209 8309 50117571
Foot fracture 15.48 10.27 272 478972 19819 50106061
Multiple-drug resistance 15.46 10.27 6 479238 3308 50122572
Dyskinesia 15.41 10.27 179 479065 27682 50098198
Hallucinations, mixed 15.28 10.27 10 479234 4093 50121787
Klebsiella infection 15.23 10.27 28 479216 7166 50118714
Wrong product administered 15.17 10.27 17 479227 5343 50120537
Vision blurred 15.11 10.27 600 478644 78047 50047833
Benign neoplasm of adrenal gland 15.08 10.27 7 479237 26 50125854
Immune reconstitution inflammatory syndrome 15.06 10.27 18 479226 5498 50120382
Intestinal resection 15.02 10.27 53 479191 2314 50123566
Breast feeding 15.00 10.27 28 479216 820 50125060
Cyst 14.97 10.27 179 479065 12008 50113872
Rash erythematous 14.90 10.27 236 479008 34616 50091264
Oedema peripheral 14.77 10.27 1291 477953 156670 49969210
Acute pulmonary oedema 14.76 10.27 29 479215 7238 50118642
Eye infection 14.73 10.27 145 479099 9261 50116619
Congenital arterial malformation 14.63 10.27 17 479227 320 50125560
Acute chest syndrome 14.62 10.27 24 479220 633 50125247
Hyperthermia 14.55 10.27 32 479212 7664 50118216
Purging 14.51 10.27 8 479236 46 50125834
Hyperammonaemia 14.47 10.27 14 479230 4710 50121170
Haemoglobin decreased 14.47 10.27 1396 477848 125820 50000060
Acute respiratory distress syndrome 14.37 10.27 129 479115 20970 50104910
Chest pain 14.36 10.27 1461 477783 175421 49950459
Purpura 14.35 10.27 47 479197 9864 50116016
Pulmonary tuberculosis 14.32 10.27 79 479165 4194 50121686
Catheter site erythema 14.30 10.27 10 479234 3952 50121928
Tendonitis 14.28 10.27 230 479014 16475 50109405
Foetal anticonvulsant syndrome 14.25 10.27 22 479222 550 50125330
Catheter site pain 14.25 10.27 9 479235 3753 50122127
Drug tolerance decreased 14.24 10.27 141 479103 9019 50116861
Mucosal inflammation 14.24 10.27 281 478963 39861 50086019
Crohn's disease 14.22 10.27 85 479159 4648 50121232
Complication of device insertion 14.19 10.27 22 479222 6019 50119861
Interstitial lung disease 14.17 10.27 389 478855 52787 50073093
Epstein-Barr virus infection 14.15 10.27 28 479216 6969 50118911
Colitis microscopic 14.14 10.27 25 479219 6495 50119385
Respiratory acidosis 14.11 10.27 22 479222 6006 50119874
Oliguria 14.06 10.27 36 479208 8180 50117700
Injection site haematoma 14.05 10.27 102 479142 5958 50119922
Device related infection 14.03 10.27 127 479117 20608 50105272
Toxic encephalopathy 14.02 10.27 19 479225 5496 50120384
Sensory loss 13.98 10.27 123 479121 7615 50118265
Joint noise 13.87 10.27 69 479175 3518 50122362
Lethargy 13.86 10.27 359 478885 49073 50076807
Pulmonary congestion 13.83 10.27 86 479158 15161 50110719
Synovial disorder 13.83 10.27 28 479216 872 50125008
Joint dislocation 13.80 10.27 178 479066 12155 50113725
Neutropenic colitis 13.79 10.27 3 479241 2414 50123466
Diabetes mellitus 13.77 10.27 356 478888 48677 50077203
Epilepsy 13.77 10.27 134 479110 21433 50104447
Blood iron increased 13.75 10.27 36 479208 1332 50124548
Premature delivery 13.74 10.27 307 478937 23356 50102524
Metabolic surgery 13.70 10.27 30 479214 988 50124892
Chronic graft versus host disease 13.69 10.27 5 479239 2862 50123018
Hepatitis cholestatic 13.69 10.27 23 479221 6094 50119786
Treatment noncompliance 13.63 10.27 202 479042 29948 50095932
Coronary arterial stent insertion 13.62 10.27 4 479240 2630 50123250
Product administered to patient of inappropriate age 13.59 10.27 4 479240 2626 50123254
Clear cell renal cell carcinoma 13.49 10.27 33 479211 1170 50124710
Cardiac failure acute 13.48 10.27 37 479207 8213 50117667
Faecal calprotectin increased 13.46 10.27 48 479196 2107 50123773
Hernia 13.46 10.27 144 479100 9399 50116481
Generalised tonic-clonic seizure 13.42 10.27 172 479072 26138 50099742
Injection site warmth 13.42 10.27 195 479049 13671 50112209
Hepatic necrosis 13.42 10.27 18 479226 5230 50120650
Aspiration 13.37 10.27 44 479200 9220 50116660
Diabetes insipidus 13.36 10.27 3 479241 2361 50123519
Paralysis 13.31 10.27 40 479204 8624 50117256
Generalised oedema 13.22 10.27 76 479168 13655 50112225
Infection 13.22 10.27 1850 477394 171104 49954776
Body temperature increased 13.14 10.27 213 479031 31128 50094752
Scleritis 13.14 10.27 63 479181 3164 50122716
Hypoglycaemic coma 13.10 10.27 3 479241 2330 50123550
Paranoia 13.05 10.27 52 479192 10296 50115584
Atrioventricular block 13.03 10.27 26 479218 6452 50119428
Myocardial ischaemia 13.03 10.27 61 479183 11552 50114328
Cystitis 13.01 10.27 531 478713 44033 50081847
Graft versus host disease in skin 13.01 10.27 4 479240 2552 50123328
Electrocardiogram QRS complex prolonged 13.00 10.27 19 479225 5325 50120555
Visual acuity reduced 12.91 10.27 125 479119 20014 50105866
Tenosynovitis 12.90 10.27 155 479089 10410 50115470
Second primary malignancy 12.86 10.27 29 479215 6885 50118995
Nephrectomy 12.86 10.27 26 479218 809 50125071
Hallucination, auditory 12.85 10.27 55 479189 10673 50115207
Dialysis 12.83 10.27 46 479198 9392 50116488
Adenovirus infection 12.82 10.27 7 479237 3161 50122719
Fracture delayed union 12.80 10.27 49 479195 2227 50123653
Hepatitis acute 12.78 10.27 36 479208 7925 50117955
Hyperbilirubinaemia 12.77 10.27 47 479197 9523 50116357
Tubulointerstitial nephritis 12.69 10.27 88 479156 15123 50110757
Body height below normal 12.68 10.27 44 479200 1905 50123975
Activated partial thromboplastin time prolonged 12.62 10.27 26 479218 6376 50119504
Post procedural infection 12.46 10.27 118 479126 7458 50118422
Ingrown hair 12.45 10.27 19 479225 470 50125410
Cytopenia 12.44 10.27 42 479202 8733 50117147
Bronchitis 12.44 10.27 1147 478097 103012 50022868
Pericardial effusion 12.43 10.27 169 479075 25420 50100460
Hallucination, visual 12.37 10.27 99 479145 16483 50109397
Polyuria 12.35 10.27 31 479213 7090 50118790
Soft tissue disorder 12.33 10.27 13 479231 4201 50121679
Sexual dysfunction 12.30 10.27 8 479236 3284 50122596
Hypernatraemia 12.18 10.27 26 479218 6295 50119585
Depression 12.13 10.27 1376 477868 164047 49961833
Rectal abscess 12.13 10.27 29 479215 1013 50124867
Asthma 12.13 10.27 707 478537 88630 50037250
Dysphagia 12.10 10.27 605 478639 76913 50048967
Dactylitis 12.10 10.27 42 479202 1819 50124061
Hepatitis fulminant 12.09 10.27 7 479237 3061 50122819
Bone density abnormal 12.08 10.27 59 479185 2986 50122894
Schizoaffective disorder 12.07 10.27 3 479241 2203 50123677
Joint lock 12.06 10.27 45 479199 2020 50123860
Potentiating drug interaction 12.06 10.27 11 479233 3805 50122075
Tonsillar inflammation 12.05 10.27 9 479235 93 50125787
Talipes 12.02 10.27 35 479209 1379 50124501
Therapeutic reaction time decreased 12.01 10.27 34 479210 1318 50124562
Peripheral sensory neuropathy 11.97 10.27 28 479216 6563 50119317
Immunodeficiency 11.88 10.27 202 479042 14626 50111254
Metastases to lymph nodes 11.85 10.27 31 479213 6993 50118887
Medication error 11.84 10.27 256 478988 35848 50090032
Right ventricular failure 11.80 10.27 95 479149 15798 50110082
Drug screen positive 11.74 10.27 9 479235 3393 50122487
Injection site irritation 11.74 10.27 76 479168 4274 50121606
Cerebral haematoma 11.73 10.27 8 479236 3203 50122677
Persecutory delusion 11.68 10.27 4 479240 2383 50123497
Renal tubular necrosis 11.65 10.27 53 479191 10115 50115765
Stress 11.62 10.27 622 478622 53171 50072709
Antibody test positive 11.58 10.27 48 479196 2263 50123617
C-reactive protein increased 11.58 10.27 754 478490 65720 50060160
Gestational hypertension 11.58 10.27 46 479198 2127 50123753
Skin toxicity 11.53 10.27 12 479232 3901 50121979
Haemorrhage in pregnancy 11.49 10.27 39 479205 1670 50124210
Hyperlipidaemia 11.45 10.27 108 479136 17382 50108498
Mouth ulceration 11.44 10.27 347 478897 27677 50098203
Granulocytopenia 11.40 10.27 20 479224 5211 50120669
Immunosuppression 11.40 10.27 114 479130 7312 50118568
Renal mass 11.37 10.27 42 479202 1876 50124004
Cystitis haemorrhagic 11.31 10.27 11 479233 3691 50122189
Anhedonia 11.30 10.27 49 479195 9475 50116405
Knee operation 11.29 10.27 82 479162 4791 50121089
Swollen tongue 11.22 10.27 197 479047 28433 50097447
Therapeutic response decreased 11.20 10.27 551 478693 46680 50079200
Cerebrovascular accident 11.17 10.27 759 478485 93921 50031959
Catheter management 11.16 10.27 6 479238 2733 50123147
Device deployment issue 11.14 10.27 10 479234 3486 50122394
Sinus bradycardia 11.13 10.27 76 479168 13107 50112773
Bone lesion 11.06 10.27 20 479224 5150 50120730
Alcoholic seizure 11.01 10.27 3 479241 0 50125880
Myringitis 11.01 10.27 3 479241 0 50125880
Vasa praevia 11.01 10.27 3 479241 0 50125880
Red blood cell count 11.01 10.27 3 479241 0 50125880
Portal vein cavernous transformation 11.01 10.27 3 479241 0 50125880
Ankylosing spondylitis 11.00 10.27 110 479134 7055 50118825
Abdominal pain 10.95 10.27 2020 477224 234208 49891672
Hypoalbuminaemia 10.94 10.27 52 479192 9808 50116072
Copper deficiency 10.94 10.27 7 479237 55 50125825
Carcinoma in situ of skin 10.92 10.27 12 479232 212 50125668
Kidney transplant rejection 10.90 10.27 13 479231 3974 50121906
Neuropathy peripheral 10.87 10.27 779 478465 95978 50029902
Anaemia vitamin B12 deficiency 10.86 10.27 15 479229 338 50125542
Chondropathy 10.83 10.27 44 479200 2056 50123824
Skin laceration 10.80 10.27 244 479000 18598 50107282
Subdural haematoma 10.75 10.27 75 479169 12872 50113008
Speech disorder developmental 10.73 10.27 20 479224 585 50125295
Hypercapnia 10.72 10.27 17 479227 4610 50121270
Exomphalos 10.72 10.27 19 479225 534 50125346
Ear infection 10.71 10.27 322 478922 25648 50100232
Muscle twitching 10.66 10.27 94 479150 15337 50110543
Joint warmth 10.65 10.27 33 479211 1346 50124534
Angina pectoris 10.65 10.27 179 479065 26009 50099871
Lupus-like syndrome 10.63 10.27 137 479107 9354 50116526
Cartilage injury 10.62 10.27 37 479207 1605 50124275
Balance disorder 10.62 10.27 553 478691 70037 50055843
Myocarditis 10.62 10.27 39 479205 7908 50117972
Pulmonary toxicity 10.62 10.27 23 479221 5539 50120341
Cholestasis of pregnancy 10.60 10.27 29 479215 1102 50124778
Melanocytic naevus 10.57 10.27 68 479176 3816 50122064
Haemodialysis 10.56 10.27 42 479202 8320 50117560
Burning sensation 10.53 10.27 529 478715 44917 50080963
Red blood cell sedimentation rate 10.52 10.27 64 479180 3522 50122358
Therapy partial responder 10.44 10.27 30 479214 6561 50119319
Liver function test abnormal 10.40 10.27 330 478914 44009 50081871
Systemic inflammatory response syndrome 10.38 10.27 20 479224 5029 50120851
Lung transplant 10.37 10.27 7 479237 2818 50123062
Stomatitis 10.36 10.27 1104 478140 100240 50025640
Hypertelorism 10.34 10.27 16 479228 401 50125479
Haemodynamic instability 10.32 10.27 40 479204 7984 50117896
Rebound effect 10.31 10.27 9 479235 3180 50122700
Wound infection 10.28 10.27 167 479077 11981 50113899

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
Rheumatoid arthritis 408.96 10.28 726 183864 31426 29358511
Drug abuse 390.56 10.28 28 184562 79855 29310082
Toxicity to various agents 350.06 10.28 341 184249 173320 29216617
Completed suicide 308.82 10.28 90 184500 90156 29299781
Drug interaction 216.20 10.28 580 184010 196805 29193132
Foetal exposure during pregnancy 211.14 10.28 574 184016 33293 29356644
Arthralgia 197.64 10.28 1519 183071 138098 29251839
Psoriatic arthropathy 117.72 10.28 274 184316 14417 29375520
Acute kidney injury 114.29 10.28 1082 183508 264185 29125752
Intentional overdose 102.96 10.28 56 184534 38472 29351465
Dysmorphism 102.63 10.28 109 184481 2862 29387075
Overdose 92.96 10.28 227 184363 79592 29310345
Joint swelling 89.39 10.28 573 184017 49057 29340880
Drug reaction with eosinophilia and systemic symptoms 86.77 10.28 33 184557 27959 29361978
Sickle cell anaemia with crisis 83.64 10.28 92 184498 2516 29387421
Blood pressure fluctuation 82.80 10.28 293 184297 19601 29370336
Enthesopathy 82.27 10.28 109 184481 3634 29386303
Coma 80.97 10.28 76 184514 39374 29350563
Psoriasis 73.49 10.28 396 184194 31831 29358106
Fatigue 71.96 10.28 2531 182059 314290 29075647
Pain 68.60 10.28 1474 183116 169958 29219979
Product use in unapproved indication 67.22 10.28 296 184294 86579 29303358
Premature baby 65.57 10.28 247 184343 17033 29372904
Rhabdomyolysis 65.36 10.28 180 184410 60628 29329309
Serotonin syndrome 64.54 10.28 15 184575 17497 29372440
Nasopharyngitis 64.08 10.28 611 183979 59054 29330883
Suicide attempt 62.89 10.28 72 184518 34038 29355899
Speech disorder developmental 62.42 10.28 68 184522 1839 29388098
Exposure during pregnancy 59.40 10.28 151 184439 8403 29381534
Musculoskeletal stiffness 57.03 10.28 415 184175 37043 29352894
Peripheral swelling 55.75 10.28 626 183964 63113 29326824
Neonatal respiratory distress syndrome 54.92 10.28 91 184499 3719 29386218
Febrile neutropenia 53.79 10.28 445 184145 111795 29278142
Multiple organ dysfunction syndrome 53.19 10.28 208 184382 62908 29327029
Drug dependence 52.49 10.28 33 184557 20948 29368989
Tenosynovitis 52.25 10.28 88 184502 3645 29386292
Foetal anticonvulsant syndrome 51.80 10.28 49 184541 1115 29388822
Respiratory arrest 51.57 10.28 51 184539 25782 29364155
Atrial septal defect 49.41 10.28 122 184468 6667 29383270
Cardiac arrest 47.82 10.28 325 184265 85266 29304671
Hypospadias 47.77 10.28 75 184515 2927 29387010
Sopor 47.67 10.28 6 184584 10928 29379009
Renal failure 47.43 10.28 492 184098 118107 29271830
Bradycardia 46.97 10.28 230 184360 65399 29324538
Blood pressure increased 46.79 10.28 683 183907 73120 29316817
Arthritis 45.72 10.28 290 184300 24729 29365208
Fall 45.03 10.28 1435 183155 175743 29214194
Haemoglobin decreased 44.94 10.28 937 183653 107438 29282499
Intentional product misuse 44.86 10.28 93 184497 34568 29355369
Drug resistance 44.78 10.28 41 184549 21499 29368438
Hepatic function abnormal 44.62 10.28 113 184477 39146 29350791
Maternal drugs affecting foetus 43.27 10.28 83 184507 3810 29386127
Autism spectrum disorder 42.86 10.28 58 184532 1974 29387963
Cytomegalovirus infection 42.80 10.28 49 184541 23166 29366771
Blood pressure systolic increased 42.55 10.28 213 184377 16632 29373305
Weight decreased 41.46 10.28 1234 183356 149671 29240266
Maternal exposure during pregnancy 41.12 10.28 84 184506 4039 29385898
Pain in extremity 40.76 10.28 939 183651 109494 29280443
Small for dates baby 40.63 10.28 77 184513 3502 29386435
Learning disorder 39.82 10.28 40 184550 982 29388955
Osteoarthritis 39.61 10.28 220 184370 17883 29372054
Off label use 39.15 10.28 1509 183081 299291 29090646
Cryptorchism 38.80 10.28 54 184536 1888 29388049
Basal cell carcinoma 38.01 10.28 207 184383 16703 29373234
Angioedema 37.73 10.28 90 184500 31825 29358112
Hypoglycaemia neonatal 37.57 10.28 50 184540 1674 29388263
Skin cancer 37.21 10.28 127 184463 8341 29381596
Maternal exposure during breast feeding 36.94 10.28 46 184544 1440 29388497
Synovitis 35.94 10.28 149 184441 10741 29379196
Palmar-plantar erythrodysaesthesia syndrome 35.85 10.28 24 184566 14735 29375202
Vitamin B12 deficiency 35.45 10.28 69 184521 3202 29386735
Low birth weight baby 35.31 10.28 106 184484 6502 29383435
Lactic acidosis 34.42 10.28 87 184503 30160 29359777
Drug withdrawal syndrome 34.20 10.28 37 184553 17947 29371990
Altered state of consciousness 33.49 10.28 45 184545 19844 29370093
Ventricular septal defect 32.97 10.28 70 184520 3459 29386478
Respiratory failure 32.93 10.28 418 184172 96713 29293224
Depressed level of consciousness 32.90 10.28 119 184471 36823 29353114
Suicidal ideation 32.82 10.28 109 184481 34607 29355330
Tongue disorder 32.36 10.28 82 184508 4554 29385383
Agitation 32.14 10.28 188 184402 51116 29338821
Hepatic failure 31.86 10.28 96 184494 31416 29358521
Arthropathy 31.77 10.28 237 184353 21317 29368620
Toxic epidermal necrolysis 31.67 10.28 40 184550 18113 29371824
Hypoglycaemia 31.45 10.28 175 184415 48171 29341766
Syndactyly 31.43 10.28 31 184559 744 29389193
C-reactive protein abnormal 31.37 10.28 101 184489 6435 29383502
Drug intolerance 30.75 10.28 448 184142 47931 29342006
Sedation 30.73 10.28 38 184552 17367 29372570
Hyperbilirubinaemia neonatal 30.68 10.28 30 184560 712 29389225
Foot deformity 30.12 10.28 73 184517 3942 29385995
Pyrexia 29.92 10.28 1479 183111 286143 29103794
Pathogen resistance 29.81 10.28 7 184583 8109 29381828
Heart rate decreased 29.70 10.28 261 184329 24651 29365286
Rheumatoid nodule 29.67 10.28 50 184540 2072 29387865
Developmental delay 29.62 10.28 55 184535 2463 29387474
Substance abuse 28.93 10.28 4 184586 6783 29383154
Hyperglycaemia 28.87 10.28 113 184477 34174 29355763
Joint laxity 28.57 10.28 22 184568 374 29389563
Hypermobility syndrome 28.29 10.28 21 184569 337 29389600
Neurotoxicity 27.86 10.28 30 184560 14583 29375354
Body temperature decreased 27.75 10.28 136 184454 10528 29379409
Delirium 27.64 10.28 139 184451 39258 29350679
Poisoning 27.46 10.28 14 184576 9979 29379958
Acute hepatic failure 26.99 10.28 21 184569 11931 29378006
Congenital hand malformation 26.89 10.28 25 184565 556 29389381
Pulmonary fibrosis 26.86 10.28 178 184412 15404 29374533
Jaundice neonatal 26.72 10.28 36 184554 1220 29388717
Intellectual disability 26.37 10.28 34 184556 1103 29388834
Exposure via breast milk 26.18 10.28 42 184548 1670 29388267
Talipes 26.09 10.28 43 184547 1749 29388188
Musculoskeletal pain 26.04 10.28 286 184304 28667 29361270
Joint range of motion decreased 25.90 10.28 90 184500 5964 29383973
Back disorder 25.73 10.28 89 184501 5884 29384053
Electrocardiogram QT prolonged 25.63 10.28 127 184463 36010 29353927
Back pain 25.56 10.28 827 183763 101457 29288480
Full blood count decreased 25.38 10.28 179 184411 15813 29374124
Ankylosing spondylitis 25.22 10.28 70 184520 4106 29385831
Cardiac failure 25.11 10.28 346 184244 78941 29310996
Asthenia 25.04 10.28 1610 182980 213640 29176297
Immune reconstitution inflammatory syndrome 24.51 10.28 9 184581 7793 29382144
Death 24.28 10.28 1823 182767 340261 29049676
Haemangioma congenital 24.13 10.28 22 184568 477 29389460
Blood pressure systolic abnormal 23.93 10.28 46 184544 2115 29387822
Somnolence 23.71 10.28 428 184162 93527 29296410
Infective pulmonary exacerbation of cystic fibrosis 23.67 10.28 5 184585 6231 29383706
Alanine aminotransferase abnormal 23.52 10.28 55 184535 2902 29387035
Proteinuria 23.46 10.28 39 184551 15765 29374172
Language disorder 23.30 10.28 43 184547 1916 29388021
Status epilepticus 23.09 10.28 20 184570 10774 29379163
Renal impairment 22.96 10.28 363 184227 80970 29308967
Cataract 22.94 10.28 227 184363 22151 29367786
Tendonitis 22.51 10.28 104 184486 7857 29382080
Shock 22.51 10.28 64 184526 21340 29368597
Rash maculo-papular 22.45 10.28 77 184513 24212 29365725
Lower respiratory tract infection 22.12 10.28 258 184332 26244 29363693
Plagiocephaly 22.09 10.28 21 184569 481 29389456
Psychotic disorder 22.04 10.28 60 184530 20294 29369643
Infusion related reaction 21.40 10.28 389 184201 43497 29346440
Large for dates baby 21.32 10.28 27 184563 860 29389077
Pneumonia 21.10 10.28 2294 182296 317878 29072059
Congenital oesophageal anomaly 21.08 10.28 11 184579 90 29389847
Astigmatism 20.80 10.28 28 184562 948 29388989
Malignant neoplasm progression 20.72 10.28 330 184260 73529 29316408
Anaphylactic shock 20.65 10.28 32 184558 13304 29376633
Vomiting 20.58 10.28 1099 183491 211161 29178776
Joint effusion 20.39 10.28 65 184525 4119 29385818
Anal fistula 20.29 10.28 65 184525 4130 29385807
Knee deformity 20.12 10.28 21 184569 540 29389397
Nasal disorder 20.07 10.28 34 184556 1415 29388522
Loss of personal independence in daily activities 20.06 10.28 245 184345 25195 29364742
Venoocclusive liver disease 20.06 10.28 9 184581 6908 29383029
Blood pressure diastolic decreased 20.05 10.28 92 184498 6930 29383007
Aspergillus infection 19.86 10.28 22 184568 10559 29379378
Drug-induced liver injury 19.78 10.28 69 184521 21586 29368351
Wound 19.72 10.28 136 184454 11927 29378010
Dysgraphia 19.71 10.28 41 184549 1997 29387940
Medical device implantation 19.69 10.28 21 184569 554 29389383
Knee arthroplasty 19.57 10.28 80 184510 5729 29384208
Neck mass 19.53 10.28 34 184556 1447 29388490
Faecal calprotectin increased 19.50 10.28 35 184555 1526 29388411
Poor venous access 19.11 10.28 53 184537 3108 29386829
Blood creatine phosphokinase increased 19.05 10.28 162 184428 40482 29349455
Motor developmental delay 18.98 10.28 22 184568 638 29389299
Urinary tract infection 18.84 10.28 588 184002 71766 29318171
Foetal growth restriction 18.81 10.28 59 184531 3707 29386230
Respiratory depression 18.60 10.28 35 184555 13488 29376449
Thrombocytopenia 18.43 10.28 672 183918 134151 29255786
Stevens-Johnson syndrome 18.34 10.28 48 184542 16449 29373488
Otitis media 18.28 10.28 46 184544 2543 29387394
Localised infection 18.19 10.28 148 184442 13668 29376269
Dyspraxia 18.07 10.28 17 184573 384 29389553
Throat lesion 18.04 10.28 12 184578 160 29389777
Selective eating disorder 17.92 10.28 35 184555 1628 29388309
Hepatocellular injury 17.89 10.28 70 184520 21173 29368764
Kidney infection 17.81 10.28 67 184523 4616 29385321
Caesarean section 17.80 10.28 38 184552 1885 29388052
Cardio-respiratory arrest 17.79 10.28 216 184374 50385 29339552
Vitamin D deficiency 17.73 10.28 75 184515 5454 29384483
Influenza 17.62 10.28 363 184227 41518 29348419
Post procedural infection 17.56 10.28 63 184527 4242 29385695
Finger deformity 17.48 10.28 28 184562 1112 29388825
Behaviour disorder 17.46 10.28 56 184534 3560 29386377
Attention deficit hyperactivity disorder 17.37 10.28 41 184549 2176 29387761
Brain oedema 17.37 10.28 31 184559 12189 29377748
Disseminated intravascular coagulation 17.36 10.28 65 184525 19915 29370022
Intentional self-injury 17.36 10.28 32 184558 12429 29377508
Serum ferritin increased 17.31 10.28 75 184515 5513 29384424
Acute respiratory distress syndrome 17.20 10.28 79 184511 22856 29367081
Polyarthritis 17.18 10.28 59 184531 3886 29386051
Agranulocytosis 17.14 10.28 67 184523 20273 29369664
Intestinal stenosis 17.12 10.28 37 184553 1851 29388086
Lacrimal disorder 17.12 10.28 15 184575 308 29389629
Akinesia 16.92 10.28 38 184552 1952 29387985
Osteonecrosis of jaw 16.90 10.28 50 184540 16460 29373477
Hepatic encephalopathy 16.84 10.28 35 184555 13000 29376937
Kyphosis 16.80 10.28 27 184563 1075 29388862
Dyslexia 16.76 10.28 15 184575 317 29389620
Strabismus 16.74 10.28 31 184559 1385 29388552
Neck pain 16.68 10.28 206 184384 21241 29368696
Incorrect route of product administration 16.65 10.28 26 184564 10775 29379162
Blood iron decreased 16.39 10.28 63 184527 4385 29385552
Vitamin B12 decreased 16.35 10.28 26 184564 1026 29388911
Cellulitis 16.33 10.28 388 184202 45452 29344485
Cytokine release syndrome 16.31 10.28 36 184554 13083 29376854
Hand deformity 16.27 10.28 39 184551 2091 29387846
Nephrolithiasis 16.25 10.28 235 184355 25099 29364838
Hypoaesthesia 16.24 10.28 443 184147 53024 29336913
Diabetic ketoacidosis 16.22 10.28 49 184541 16024 29373913
Joint stiffness 16.20 10.28 108 184482 9365 29380572
Blood test abnormal 16.18 10.28 75 184515 5674 29384263
Ear infection 16.12 10.28 96 184494 8004 29381933
Tachycardia 16.08 10.28 337 184253 72073 29317864
Metabolic acidosis 15.96 10.28 154 184436 37508 29352429
Sinusitis 15.88 10.28 302 184288 34048 29355889
Drug withdrawal syndrome neonatal 15.87 10.28 52 184538 3343 29386594
Spinal disorder 15.87 10.28 55 184535 3640 29386297
Pancytopenia 15.77 10.28 652 183938 82516 29307421
Hypotonia neonatal 15.76 10.28 28 184562 1211 29388726
Urticaria 15.74 10.28 243 184347 54417 29335520
Product dose omission issue 15.72 10.28 744 183846 95639 29294298
Suspected suicide 15.72 10.28 3 184587 4017 29385920
Bradycardia neonatal 15.68 10.28 24 184566 916 29389021
Aggression 15.62 10.28 144 184446 35397 29354540
Progressive multifocal leukoencephalopathy 15.43 10.28 19 184571 8700 29381237
Scoliosis 15.35 10.28 40 184550 2260 29387677
Hypoxia 15.26 10.28 206 184384 47173 29342764
Injection site pain 15.26 10.28 286 184304 32160 29357777
Hydrocele 15.18 10.28 36 184554 1917 29388020
Congenital bladder anomaly 15.12 10.28 13 184577 260 29389677
Limb reduction defect 15.08 10.28 13 184577 261 29389676
Neuroleptic malignant syndrome 15.05 10.28 51 184539 16097 29373840
Cleft lip 15.04 10.28 14 184576 312 29389625
Akathisia 15.03 10.28 12 184578 6730 29383207
Sacroiliitis 15.03 10.28 26 184564 1101 29388836
Malignant melanoma 14.99 10.28 86 184504 7075 29382862
Agitation neonatal 14.92 10.28 25 184565 1031 29388906
Gait disturbance 14.83 10.28 579 184011 72770 29317167
Colitis ulcerative 14.82 10.28 133 184457 12636 29377301
Polydactyly 14.81 10.28 26 184564 1114 29388823
Acute graft versus host disease 14.79 10.28 9 184581 5815 29384122
Weight decrease neonatal 14.78 10.28 14 184576 319 29389618
Pulmonary alveolar haemorrhage 14.67 10.28 11 184579 6369 29383568
Blood pressure diastolic abnormal 14.66 10.28 42 184548 2509 29387428
Foetal disorder 14.50 10.28 21 184569 762 29389175
Inguinal hernia 14.44 10.28 81 184509 6607 29383330
Accessory spleen 14.44 10.28 10 184580 143 29389794
Bronchopulmonary aspergillosis 14.43 10.28 35 184555 12309 29377628
Transplant rejection 14.37 10.28 22 184568 9190 29380747
Congenital foot malformation 14.36 10.28 15 184575 386 29389551
Polyhydramnios 14.29 10.28 12 184578 232 29389705
Multiple congenital abnormalities 14.29 10.28 17 184573 507 29389430
Arthritis bacterial 14.26 10.28 60 184530 4353 29385584
Grip strength decreased 14.26 10.28 39 184551 2268 29387669
Ankyloglossia congenital 14.18 10.28 13 184577 284 29389653
Seizure 14.14 10.28 458 184132 92665 29297272
Disease progression 14.14 10.28 396 184194 81520 29308417
Hyperammonaemia 14.04 10.28 9 184581 5654 29384283
Renal aplasia 14.03 10.28 19 184571 647 29389290
Saliva altered 13.98 10.28 10 184580 151 29389786
Irritability 13.96 10.28 81 184509 22071 29367866
Ear disorder 13.96 10.28 27 184563 1247 29388690
Cerebral haemorrhage 13.96 10.28 127 184463 31299 29358638
Red blood cell count decreased 13.94 10.28 231 184359 25371 29364566
Blood insulin increased 13.89 10.28 14 184576 345 29389592
Arthritis infective 13.88 10.28 44 184546 2780 29387157
Cardiogenic shock 13.86 10.28 67 184523 19123 29370814
Chronic graft versus host disease 13.80 10.28 4 184586 4025 29385912
Septic arthritis staphylococcal 13.72 10.28 16 184574 467 29389470
Transaminases increased 13.68 10.28 84 184506 22578 29367359
Second primary malignancy 13.65 10.28 13 184577 6692 29383245
Increased tendency to bruise 13.58 10.28 51 184539 3511 29386426
Hyperkalaemia 13.55 10.28 286 184304 61106 29328831
Hypertriglyceridaemia 13.54 10.28 16 184574 7459 29382478
Hypotension 13.53 10.28 1037 183553 193317 29196620
Balance disorder 13.45 10.28 308 184282 35862 29354075
Ventricular fibrillation 13.44 10.28 52 184538 15781 29374156
Juvenile idiopathic arthritis 13.43 10.28 28 184562 1366 29388571
Heart rate irregular 13.41 10.28 133 184457 12984 29376953
Pancreatitis acute 13.40 10.28 93 184497 24292 29365645
Psychomotor retardation 13.40 10.28 45 184545 2931 29387006
Hyperbilirubinaemia 13.36 10.28 48 184542 14886 29375051
Immunodeficiency 13.30 10.28 59 184531 4381 29385556
Low set ears 13.30 10.28 15 184575 422 29389515
Frequent bowel movements 13.28 10.28 101 184489 9138 29380799
Dermatitis acneiform 13.24 10.28 9 184581 5482 29384455
No adverse event 13.23 10.28 60 184530 17418 29372519
Congenital anomaly 13.18 10.28 27 184563 1301 29388636
Pectus excavatum 13.13 10.28 11 184579 212 29389725
Cholestasis 13.13 10.28 89 184501 23373 29366564
Neutropenia 13.11 10.28 680 183910 131031 29258906
Haematocrit decreased 13.02 10.28 254 184336 28768 29361169
Cystitis haemorrhagic 12.98 10.28 7 184583 4835 29385102
Ventricular tachycardia 12.95 10.28 85 184505 22489 29367448
Gamma-glutamyltransferase increased 12.78 10.28 106 184484 26631 29363306
Weight fluctuation 12.78 10.28 55 184535 4031 29385906
Drug level increased 12.77 10.28 67 184523 18720 29371217
Arthrodesis 12.73 10.28 15 184575 443 29389494
Gait apraxia 12.70 10.28 4 184586 6 29389931
Oesophageal fibrosis 12.70 10.28 10 184580 176 29389761
Medication error 12.61 10.28 79 184511 21132 29368805
Anaemia vitamin B12 deficiency 12.58 10.28 12 184578 276 29389661
Adenovirus infection 12.57 10.28 6 184584 4441 29385496
Hepatotoxicity 12.55 10.28 63 184527 17804 29372133
Potentiating drug interaction 12.52 10.28 6 184584 4432 29385505
C-reactive protein decreased 12.50 10.28 29 184561 1522 29388415
Vascular insufficiency 12.50 10.28 13 184577 333 29389604
Lordosis 12.39 10.28 11 184579 230 29389707
Acute generalised exanthematous pustulosis 12.36 10.28 10 184580 5573 29384364
BK virus infection 12.34 10.28 7 184583 4700 29385237
Microcephaly 12.30 10.28 19 184571 731 29389206
Heart rate 12.25 10.28 3 184587 0 29389937
Diaphragmatic disorder 12.25 10.28 22 184568 960 29388977
Crohn's disease 12.24 10.28 44 184546 2965 29386972
Umbilical hernia 12.24 10.28 51 184539 3684 29386253
Magnetic resonance imaging spinal abnormal 12.23 10.28 7 184583 70 29389867
Fracture 12.22 10.28 72 184518 5981 29383956
Nephropathy toxic 12.18 10.28 31 184559 10725 29379212
Sexual dysfunction 12.16 10.28 11 184579 5803 29384134
Mydriasis 12.16 10.28 12 184578 6073 29383864
Acoustic neuroma 12.15 10.28 9 184581 144 29389793
Hepatic cyst 12.14 10.28 37 184553 2288 29387649
Acute graft versus host disease in skin 12.14 10.28 7 184583 4657 29385280
Vitamin D decreased 12.10 10.28 43 184547 2882 29387055
Maternal exposure before pregnancy 12.06 10.28 15 184575 469 29389468
Chest expansion decreased 12.04 10.28 9 184581 146 29389791
Intestinal obstruction 12.04 10.28 178 184412 19099 29370838
Cytomegalovirus viraemia 12.02 10.28 13 184577 6307 29383630
Alcohol abuse 12.01 10.28 6 184584 4327 29385610
Pleural fibrosis 11.92 10.28 26 184564 1309 29388628
Therapy partial responder 11.91 10.28 9 184581 5190 29384747
Hypertelorism 11.86 10.28 16 184574 543 29389394
Bronchiolitis 11.82 10.28 41 184549 2714 29387223
Blood pressure diastolic increased 11.82 10.28 50 184540 3636 29386301
Infection 11.78 10.28 589 184001 76162 29313775
Abscess intestinal 11.76 10.28 27 184563 1407 29388530
Stoma site inflammation 11.73 10.28 14 184576 419 29389518
Obsessive-compulsive disorder 11.72 10.28 7 184583 4569 29385368
Plasma cell myeloma 11.69 10.28 309 184281 36806 29353131
Posterior reversible encephalopathy syndrome 11.68 10.28 24 184566 8952 29380985
Maternal exposure timing unspecified 11.66 10.28 13 184577 361 29389576
Nocardiosis 11.61 10.28 3 184587 3257 29386680
Arnold-Chiari malformation 11.52 10.28 12 184578 308 29389629
Pernicious anaemia 11.51 10.28 7 184583 79 29389858
Cytomegalovirus chorioretinitis 11.49 10.28 3 184587 3235 29386702
Thrombotic microangiopathy 11.48 10.28 23 184567 8658 29381279
Hernia pain 11.46 10.28 11 184579 255 29389682
Blood magnesium decreased 11.43 10.28 65 184525 5329 29384608
Folate deficiency 11.43 10.28 23 184567 1094 29388843
Septic shock 11.42 10.28 300 184290 62260 29327677
Hepatitis fulminant 11.42 10.28 4 184586 3567 29386370
Intestinal resection 11.42 10.28 27 184563 1435 29388502
Skin lesion 11.41 10.28 171 184419 18401 29371536
Excessive cerumen production 11.39 10.28 11 184579 257 29389680
On and off phenomenon 11.33 10.28 32 184558 1896 29388041
Peripheral artery thrombosis 11.30 10.28 34 184556 2088 29387849
Patent ductus arteriosus 11.26 10.28 44 184546 3087 29386850
Product quality issue 11.19 10.28 56 184534 15839 29374098
Cardiotoxicity 11.14 10.28 8 184582 4736 29385201
Dystonia 11.12 10.28 28 184562 9721 29380216
Cholelithiasis 11.11 10.28 171 184419 18501 29371436
Renal injury 11.10 10.28 30 184560 10172 29379765
Lipase increased 11.10 10.28 22 184568 8315 29381622
Abdominal hernia 11.07 10.28 38 184552 2502 29387435
Prominent epicanthal folds 11.07 10.28 9 184581 166 29389771
Ileal stenosis 11.05 10.28 24 184566 1205 29388732
Tooth malformation 11.03 10.28 9 184581 167 29389770
Hip fracture 11.03 10.28 107 184483 10385 29379552
Contusion 11.01 10.28 263 184327 30832 29359105
Rheumatoid lung 11 10.28 13 184577 385 29389552
Cerebral microangiopathy 10.98 10.28 9 184581 168 29389769
Nephrotic syndrome 10.98 10.28 14 184576 6314 29383623
Injection site bruising 10.97 10.28 83 184507 7497 29382440
Injection site swelling 10.88 10.28 98 184492 9319 29380618
Tubulointerstitial nephritis 10.86 10.28 65 184525 17578 29372359
Benign abdominal neoplasm 10.81 10.28 7 184583 89 29389848
Respiratory disorder neonatal 10.79 10.28 26 184564 1399 29388538
Radiation inflammation 10.77 10.28 10 184580 222 29389715
Withdrawal syndrome 10.74 10.28 34 184556 10958 29378979
Anal atresia 10.72 10.28 11 184579 277 29389660
Hypothyroidism 10.66 10.28 57 184533 15849 29374088
Developmental coordination disorder 10.64 10.28 9 184581 176 29389761
Peripheral coldness 10.60 10.28 71 184519 6165 29383772
Erythema multiforme 10.59 10.28 20 184570 7697 29382240
Mouth ulceration 10.59 10.28 105 184485 10250 29379687
Mania 10.58 10.28 24 184566 8639 29381298
Steatorrhoea 10.58 10.28 17 184573 677 29389260
Cyst 10.55 10.28 51 184539 3926 29386011
Unresponsive to stimuli 10.53 10.28 103 184487 25023 29364914
Spina bifida 10.52 10.28 12 184578 342 29389595
Shock haemorrhagic 10.46 10.28 28 184562 9523 29380414
Ulna fracture 10.43 10.28 12 184578 345 29389592
Gangrene 10.41 10.28 53 184537 4165 29385772
Congenital hydronephrosis 10.41 10.28 17 184573 686 29389251
Injection site erythema 10.40 10.28 133 184457 13823 29376114
Anti-erythropoietin antibody positive 10.39 10.28 19 184571 841 29389096
Foetal heart rate deceleration abnormality 10.38 10.28 14 184576 475 29389462
Wrong technique in product usage process 10.36 10.28 136 184454 31292 29358645
Pulmonary valve stenosis 10.32 10.28 12 184578 349 29389588

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 1175.04 10.02 172 500750 224242 63773568
Toxicity to various agents 1032.47 10.02 789 500133 362724 63635086
Rheumatoid arthritis 967.07 10.02 3140 497782 161154 63836656
Drug abuse 804.26 10.02 58 500864 132316 63865494
Arthropathy 577.59 10.02 2158 498764 118809 63879001
Drug interaction 576.67 10.02 1219 499703 360864 63636946
Arthralgia 574.90 10.02 5596 495326 436664 63561146
Pemphigus 573.40 10.02 1379 499543 59322 63938488
Systemic lupus erythematosus 551.13 10.02 1585 499337 76027 63921783
Joint swelling 537.91 10.02 3180 497742 212202 63785608
Hand deformity 520.47 10.02 1357 499565 61414 63936396
Glossodynia 490.43 10.02 1353 499569 63343 63934467
Synovitis 489.08 10.02 1787 499135 97303 63900507
Infusion related reaction 431.00 10.02 2460 498462 162007 63835803
Maternal exposure during pregnancy 422.66 10.02 1668 499254 94216 63903594
Pain 421.67 10.02 6328 494594 547183 63450627
Wound 388.16 10.02 1392 499530 75085 63922725
Anti-cyclic citrullinated peptide antibody positive 386.04 10.02 1047 499875 48515 63949295
Abdominal discomfort 383.45 10.02 2577 498345 179745 63818065
Nasopharyngitis 372.80 10.02 2704 498218 193369 63804441
Intentional overdose 363.99 10.02 122 500800 89822 63907988
Pericarditis 363.73 10.02 1191 499731 61325 63936485
Alopecia 352.02 10.02 2348 498574 163342 63834468
Acute kidney injury 327.87 10.02 2094 498828 447146 63550664
Overdose 295.16 10.02 490 500432 159076 63838734
Swelling 270.93 10.02 2150 498772 158068 63839742
Discomfort 270.53 10.02 1295 499627 79583 63918227
Therapeutic product effect decreased 253.55 10.02 1649 499273 113702 63884108
Cardiac arrest 252.08 10.02 510 500412 153554 63844256
Febrile neutropenia 246.13 10.02 698 500224 186959 63810851
Musculoskeletal stiffness 242.57 10.02 1714 499208 121492 63876318
Rheumatoid factor positive 230.19 10.02 695 500227 34243 63963567
Fatigue 228.95 10.02 7510 493412 741220 63256590
Death 224.29 10.02 2533 498389 480172 63517638
Contraindicated product administered 219.84 10.02 1513 499409 106316 63891494
Helicobacter infection 216.97 10.02 724 500198 37638 63960172
Duodenal ulcer perforation 216.22 10.02 676 500246 33949 63963861
Peripheral swelling 214.46 10.02 2526 498396 206627 63791183
Psoriatic arthropathy 211.24 10.02 778 500144 42503 63955307
Sinusitis 210.99 10.02 1891 499031 144037 63853773
Drug reaction with eosinophilia and systemic symptoms 209.99 10.02 79 500843 54138 63943672
Suicide attempt 205.04 10.02 151 500771 70856 63926954
Exposure during pregnancy 202.02 10.02 1160 499762 76515 63921295
Blood pressure fluctuation 188.47 10.02 851 500071 51020 63946790
Depressed level of consciousness 187.83 10.02 213 500709 81223 63916587
Drug intolerance 181.56 10.02 2245 498677 185747 63812063
Hepatic enzyme increased 181.27 10.02 1671 499251 128272 63869538
Respiratory arrest 178.81 10.02 94 500828 52891 63944919
Rhabdomyolysis 178.69 10.02 272 500650 91454 63906356
Bradycardia 166.79 10.02 424 500498 117795 63880015
Arthritis 161.41 10.02 1160 499762 82654 63915156
C-reactive protein abnormal 154.42 10.02 537 500385 28510 63969300
Impaired healing 153.25 10.02 897 500025 59576 63938234
Multiple organ dysfunction syndrome 151.51 10.02 353 500569 101060 63896750
Lactic acidosis 150.09 10.02 153 500769 61257 63936553
Renal failure 147.96 10.02 817 500105 180871 63816939
Psoriasis 146.02 10.02 1006 499916 70697 63927113
Product use issue 145.66 10.02 1810 499112 149905 63847905
Serotonin syndrome 144.35 10.02 62 500860 39220 63958590
Weight increased 144.09 10.02 2393 498529 210955 63786855
Hepatic function abnormal 140.00 10.02 176 500746 64137 63933673
Malignant neoplasm progression 136.29 10.02 436 500486 112435 63885375
Sopor 135.23 10.02 32 500890 29629 63968181
Lower respiratory tract infection 134.60 10.02 1222 499700 93392 63904418
Cardio-respiratory arrest 133.36 10.02 360 500562 98033 63899777
Red blood cell sedimentation rate abnormal 132.50 10.02 350 500572 15956 63981854
Cardiac failure 132.39 10.02 553 500369 131820 63865990
Sickle cell anaemia with crisis 131.85 10.02 184 500738 5148 63992662
Respiratory failure 131.66 10.02 724 500198 160459 63837351
Drug resistance 129.62 10.02 55 500867 35047 63962763
Osteoarthritis 128.60 10.02 888 500034 62448 63935362
Sedation 126.54 10.02 83 500839 41379 63956431
Hypotension 125.18 10.02 2143 498779 378831 63618979
Coma 123.75 10.02 314 500608 87301 63910509
Cytomegalovirus infection 122.58 10.02 68 500854 37131 63960679
Hepatic failure 122.24 10.02 150 500772 55244 63942566
Electrocardiogram QT prolonged 119.10 10.02 276 500646 79172 63918638
Pain in extremity 116.44 10.02 3130 497792 299955 63697855
Neutropenia 115.52 10.02 1246 499676 238378 63759432
Hypersensitivity 112.88 10.02 2148 498774 194304 63803506
Hip arthroplasty 112.86 10.02 394 500528 20957 63976853
Knee arthroplasty 112.71 10.02 462 500460 26537 63971273
Contusion 111.66 10.02 1365 499557 112600 63885210
Agitation 111.16 10.02 335 500587 88032 63909778
Product use in unapproved indication 110.91 10.02 859 500063 175759 63822051
Muscle injury 110.85 10.02 453 500469 25984 63971826
Renal impairment 107.24 10.02 612 500310 134405 63863405
Hypoglycaemia 105.90 10.02 351 500571 89541 63908269
Irritable bowel syndrome 105.05 10.02 570 500352 36799 63961011
Hyponatraemia 105.01 10.02 697 500225 147642 63850168
Sleep disorder due to general medical condition, insomnia type 103.78 10.02 442 500480 25828 63971982
Injection site erythema 99.44 10.02 912 500010 69888 63927922
Folliculitis 99.36 10.02 480 500442 29597 63968213
Blood pressure increased 99.21 10.02 1887 499035 170665 63827145
Drug dependence 98.56 10.02 69 500853 33243 63964567
Enthesopathy 95.31 10.02 223 500699 9415 63988395
Pregnancy 95.10 10.02 367 500555 20498 63977312
Thrombocytopenia 94.95 10.02 1197 499725 222604 63775206
Blood pressure systolic increased 92.62 10.02 680 500242 48773 63949037
Poisoning 91.45 10.02 28 500894 21851 63975959
Fibromyalgia 90.50 10.02 530 500392 35201 63962609
Respiratory depression 89.37 10.02 35 500887 23408 63974402
Metabolic acidosis 89.25 10.02 269 500653 70689 63927121
Abortion spontaneous 88.70 10.02 409 500513 24734 63973076
Injection site pain 87.85 10.02 1283 499639 110125 63887685
Tachycardia 85.90 10.02 745 500177 148834 63848976
Blister 85.11 10.02 983 499939 79984 63917826
Injection site pruritus 85.02 10.02 544 500378 37282 63960528
Intentional self-injury 84.82 10.02 61 500861 28983 63968827
Treatment failure 83.89 10.02 1324 499598 115492 63882318
Hyperglycaemia 83.40 10.02 222 500700 60746 63937064
Heart rate decreased 82.80 10.02 720 500202 54347 63943463
Ill-defined disorder 82.08 10.02 605 500317 43447 63954363
Intentional product misuse 80.61 10.02 289 500633 72006 63925804
Disseminated intravascular coagulation 78.57 10.02 81 500841 32267 63965543
Cholestasis 78.16 10.02 143 500779 44729 63953081
Disease progression 78.13 10.02 713 500209 140967 63856843
Hepatocellular injury 77.16 10.02 146 500776 45089 63952721
Shock 76.78 10.02 111 500811 38129 63959681
Oropharyngeal pain 76.73 10.02 1040 499882 87827 63909983
Angioedema 75.16 10.02 238 500684 61583 63936227
Acute hepatic failure 73.48 10.02 57 500865 26055 63971755
Delirium 72.97 10.02 283 500639 68911 63928899
Weight decreased 70.24 10.02 2799 498123 282940 63714870
Injection site swelling 69.81 10.02 555 500367 40798 63957012
Loss of personal independence in daily activities 69.72 10.02 865 500057 71589 63926221
Hypoxia 69.20 10.02 401 500521 87748 63910062
Mydriasis 68.86 10.02 17 500905 15295 63982515
Altered state of consciousness 68.53 10.02 118 500804 37784 63960026
Injection site reaction 68.02 10.02 606 500316 46058 63951752
Infection 67.97 10.02 1899 499023 182981 63814829
Juvenile idiopathic arthritis 67.85 10.02 114 500808 3765 63994045
Joint effusion 67.25 10.02 244 500678 13229 63984581
Leukopenia 67.04 10.02 485 500437 100757 63897053
Encephalopathy 67.00 10.02 233 500689 58586 63939224
Grip strength decreased 66.92 10.02 222 500700 11502 63986308
Red blood cell sedimentation rate increased 66.41 10.02 443 500479 30792 63967018
Osteoporosis 66.32 10.02 556 500366 41524 63956286
Hyperkalaemia 66.22 10.02 486 500436 100643 63897167
Blood creatine phosphokinase increased 65.34 10.02 234 500688 58324 63939486
Disability assessment scale score increased 65.10 10.02 89 500833 2441 63995369
Localised infection 64.26 10.02 428 500494 29733 63968077
Palmar-plantar erythrodysaesthesia syndrome 63.62 10.02 78 500844 28741 63969069
Musculoskeletal pain 63.60 10.02 935 499987 80359 63917451
Blood pressure diastolic decreased 63.24 10.02 341 500581 21960 63975850
Device expulsion 62.24 10.02 44 500878 21092 63976718
Somnolence 62.15 10.02 1160 499762 202485 63795325
Blood pressure systolic abnormal 61.96 10.02 194 500728 9748 63988062
Condition aggravated 61.68 10.02 3508 497414 368918 63628892
Post transplant lymphoproliferative disorder 61.51 10.02 3 500919 9541 63988269
Blood pressure diastolic abnormal 61.33 10.02 218 500704 11699 63986111
Rash 61.03 10.02 4238 496684 454311 63543499
Drug hypersensitivity 60.95 10.02 1394 499528 236421 63761389
Drug withdrawal syndrome 60.71 10.02 93 500829 31198 63966612
Hypothermia 60.25 10.02 40 500882 19816 63977994
Neurotoxicity 59.62 10.02 75 500847 27329 63970481
Live birth 58.56 10.02 206 500716 10998 63986812
Seizure 57.55 10.02 930 499992 165962 63831848
Injection site bruising 57 10.02 480 500442 35893 63961917
Caesarean section 56.97 10.02 205 500717 11069 63986741
Neuroleptic malignant syndrome 56.94 10.02 66 500856 24930 63972880
Rheumatic fever 56.67 10.02 180 500742 9114 63988696
Influenza 56.46 10.02 1151 499771 105380 63892430
Rheumatoid nodule 55.61 10.02 220 500702 12431 63985379
Agranulocytosis 55.53 10.02 135 500787 38094 63959716
Body temperature decreased 55.28 10.02 368 500554 25560 63972250
Status epilepticus 55.20 10.02 52 500870 21611 63976199
Ventricular tachycardia 54.65 10.02 115 500807 34150 63963660
Anaphylactic shock 54.30 10.02 95 500827 30233 63967577
Torsade de pointes 54.01 10.02 34 500888 17329 63980481
Sedation complication 53.96 10.02 8 500914 10346 63987464
Venoocclusive liver disease 53.93 10.02 7 500915 10008 63987802
Respiratory distress 53.92 10.02 216 500706 52115 63945695
Myocardial infarction 53.92 10.02 934 499988 164887 63832923
Femur fracture 53.77 10.02 451 500471 33684 63964126
Drug ineffective 53.38 10.02 7372 493550 832875 63164935
Cardiac failure congestive 53.26 10.02 704 500218 129876 63867934
Infective pulmonary exacerbation of cystic fibrosis 53.23 10.02 13 500909 11783 63986027
Basal cell carcinoma 53.22 10.02 416 500506 30422 63967388
Joint laxity 53.01 10.02 77 500845 2237 63995573
Posterior reversible encephalopathy syndrome 52.91 10.02 60 500862 22886 63974924
Swollen joint count increased 52.57 10.02 155 500767 7534 63990276
Carpal tunnel syndrome 52.56 10.02 253 500669 15575 63982235
Aspergillus infection 52.45 10.02 31 500891 16348 63981462
Cardiogenic shock 52.42 10.02 108 500814 32319 63965491
Vomiting 52.35 10.02 3631 497291 547486 63450324
Proteinuria 52.26 10.02 84 500838 27639 63970171
Transplant rejection 51.53 10.02 36 500886 17365 63980445
Cerebral haemorrhage 51.31 10.02 213 500709 50877 63946933
Ascites 50.85 10.02 278 500644 61723 63936087
Accidental overdose 50.74 10.02 116 500806 33441 63964369
Brain oedema 50.60 10.02 58 500864 22017 63975793
Ventricular fibrillation 50.16 10.02 67 500855 23793 63974017
Joint stiffness 49.66 10.02 405 500517 29999 63967811
Fall 49.57 10.02 3818 497104 413008 63584802
Skin cancer 49.27 10.02 204 500718 11770 63986040
Pathogen resistance 49.03 10.02 18 500904 12525 63985285
Tenosynovitis 49.00 10.02 202 500720 11631 63986179
Substance abuse 48.84 10.02 7 500915 9285 63988525
Ejection fraction decreased 47.78 10.02 94 500828 28613 63969197
Poor venous access 47.56 10.02 207 500715 12210 63985600
Toxic epidermal necrolysis 47.37 10.02 140 500782 37026 63960784
Foot deformity 47.23 10.02 253 500669 16251 63981559
Immune reconstitution inflammatory syndrome 46.91 10.02 19 500903 12451 63985359
Inflammation 46.81 10.02 740 500182 64560 63933250
Injection site rash 46.20 10.02 243 500679 15499 63982311
Bronchopulmonary aspergillosis 46.11 10.02 48 500874 19037 63978773
Rash maculo-papular 46.03 10.02 198 500724 46828 63950982
Hypokalaemia 45.86 10.02 668 500254 121235 63876575
Suicidal ideation 44.41 10.02 318 500604 66224 63931586
Cytokine release syndrome 44.29 10.02 58 500864 20771 63977039
Aggression 43.83 10.02 197 500725 46035 63951775
Unresponsive to stimuli 43.53 10.02 222 500700 50171 63947639
Anaphylactic reaction 43.51 10.02 333 500589 68331 63929479
Drug level increased 43.45 10.02 129 500793 34067 63963743
Synovial cyst 43.16 10.02 145 500777 7562 63990248
Neck mass 42.67 10.02 96 500826 3948 63993862
Thrombotic microangiopathy 42.41 10.02 40 500882 16615 63981195
Gestational diabetes 42.41 10.02 117 500805 5473 63992337
Mucormycosis 42.39 10.02 4 500918 7337 63990473
Coagulopathy 42.32 10.02 118 500804 31802 63966008
Tendonitis 42.12 10.02 286 500636 19996 63977814
Neurologic neglect syndrome 41.76 10.02 57 500865 1561 63996249
Intentional product use issue 41.25 10.02 1001 499921 94363 63903447
Miosis 41.24 10.02 26 500896 13240 63984570
Gamma-glutamyltransferase increased 41.17 10.02 215 500707 48295 63949515
Acute graft versus host disease 41.02 10.02 10 500912 9074 63988736
Pyrexia 40.91 10.02 3759 497163 554885 63442925
Graft versus host disease 40.35 10.02 29 500893 13784 63984026
Extrapyramidal disorder 40.00 10.02 56 500866 19496 63978314
Joint injury 39.84 10.02 310 500612 22637 63975173
Diabetic ketoacidosis 39.82 10.02 110 500812 29735 63968075
Herpes zoster 39.81 10.02 849 500073 78338 63919472
Polyarthritis 39.57 10.02 165 500757 9550 63988260
Blood pressure diastolic increased 39.49 10.02 177 500745 10575 63987235
Spinal stenosis 39.48 10.02 213 500709 13718 63984092
Tumour lysis syndrome 39.45 10.02 56 500866 19384 63978426
Tongue disorder 39.33 10.02 192 500730 11888 63985922
Sepsis 39.27 10.02 1428 499494 228913 63768897
Tachypnoea 39.25 10.02 93 500829 26478 63971332
Septic shock 39.23 10.02 579 500343 104858 63892952
Haematotoxicity 39.10 10.02 26 500896 12870 63984940
Gastrointestinal disorder 38.91 10.02 942 499980 88767 63909043
Coronary artery disease 38.80 10.02 292 500630 60141 63937669
Acute respiratory distress syndrome 38.68 10.02 163 500759 38772 63959038
Asphyxia 38.64 10.02 13 500909 9553 63988257
Carotid artery thrombosis 38.63 10.02 58 500864 1737 63996073
Pancreatitis acute 38.62 10.02 186 500736 42669 63955141
Haemoptysis 38.55 10.02 223 500699 48825 63948985
Frequent bowel movements 38.54 10.02 259 500663 18046 63979764
Drug-induced liver injury 38.31 10.02 215 500707 47428 63950382
Bronchitis 38.27 10.02 1111 499811 107632 63890178
Intestinal stenosis 38.14 10.02 80 500842 3134 63994676
Fear 38.13 10.02 61 500861 20110 63977700
Akathisia 37.98 10.02 21 500901 11489 63986321
Disturbance in attention 37.76 10.02 177 500745 40897 63956913
Surgery 37.38 10.02 359 500563 27854 63969956
Sensitisation 37.35 10.02 56 500866 1675 63996135
Melaena 37.16 10.02 253 500669 53295 63944515
Maternal exposure before pregnancy 37.11 10.02 83 500839 3400 63994410
Myoclonus 37.04 10.02 88 500834 25030 63972780
Osteonecrosis of jaw 36.98 10.02 171 500751 39654 63958156
Adjustment disorder 36.95 10.02 72 500850 2673 63995137
Fracture 36.90 10.02 261 500661 18494 63979316
Hepatotoxicity 36.86 10.02 172 500750 39790 63958020
Toxic skin eruption 36.75 10.02 58 500864 19226 63978584
Blood alkaline phosphatase increased 36.57 10.02 271 500651 56008 63941802
Cerebral infarction 36.49 10.02 179 500743 40865 63956945
Neck deformity 36.39 10.02 55 500867 1657 63996153
Sinus tachycardia 36.32 10.02 128 500794 32060 63965750
Joint range of motion decreased 36.22 10.02 266 500656 19077 63978733
Rhinorrhoea 36.21 10.02 661 500261 59308 63938502
Bone erosion 36.12 10.02 182 500740 11413 63986397
Psychotic disorder 36.08 10.02 142 500780 34436 63963374
Orthostatic hypotension 35.93 10.02 214 500708 46524 63951286
BK virus infection 35.82 10.02 7 500915 7405 63990405
Mental status changes 35.81 10.02 303 500619 60859 63936951
International normalised ratio increased 35.58 10.02 418 500504 78749 63919061
Aspartate aminotransferase increased 35.39 10.02 686 500236 119102 63878708
Anaemia 35.21 10.02 2499 498423 376181 63621629
Creatinine renal clearance decreased 35.15 10.02 36 500886 14385 63983425
Ischaemic stroke 35.13 10.02 112 500810 28923 63968887
Febrile bone marrow aplasia 35.06 10.02 22 500900 11233 63986577
Laryngitis 34.97 10.02 174 500748 10857 63986953
Urinary tract infection 34.95 10.02 2164 498758 229432 63768378
Syncope 34.93 10.02 944 499978 156691 63841119
Stevens-Johnson syndrome 34.88 10.02 142 500780 34107 63963703
Arrhythmia 34.86 10.02 254 500668 52690 63945120
Pulmonary alveolar haemorrhage 34.78 10.02 16 500906 9722 63988088
Joint destruction 34.73 10.02 83 500839 3553 63994257
Polycystic ovaries 34.63 10.02 61 500861 2094 63995716
Irritability 34.58 10.02 157 500765 36589 63961221
Inappropriate antidiuretic hormone secretion 34.55 10.02 76 500846 22213 63975597
Haemophagocytic lymphohistiocytosis 34.48 10.02 52 500870 17557 63980253
Acute generalised exanthematous pustulosis 34.37 10.02 35 500887 14023 63983787
Ejection fraction 34.25 10.02 46 500876 1240 63996570
Psychomotor hyperactivity 34.18 10.02 37 500885 14414 63983396
Speech disorder 34.05 10.02 228 500694 48213 63949597
Hyperhidrosis 34.04 10.02 725 500197 124195 63873615
Gastroenteritis viral 33.96 10.02 266 500656 19463 63978347
Hyperbilirubinaemia 33.96 10.02 71 500851 21134 63976676
Dystonia 33.86 10.02 59 500863 18806 63979004
Paradoxical drug reaction 33.63 10.02 4 500918 6116 63991694
Jaundice 33.27 10.02 230 500692 48282 63949528
Pre-eclampsia 32.94 10.02 115 500807 6116 63991694
Pulmonary arterial hypertension 32.73 10.02 95 500827 25272 63972538
Ear infection 32.60 10.02 301 500621 23103 63974707
Nodule 32.58 10.02 245 500677 17702 63980108
Tenderness 32.49 10.02 262 500660 19340 63978470
Stomatitis 32.29 10.02 1096 499826 108509 63889301
Erythema multiforme 32.09 10.02 45 500877 15656 63982154
Abnormal behaviour 32.03 10.02 143 500779 33479 63964331
Mania 31.98 10.02 48 500874 16238 63981572
Pulmonary fibrosis 31.94 10.02 364 500558 29514 63968296
Foot fracture 31.92 10.02 246 500676 17911 63979899
Pleural effusion 31.78 10.02 744 500178 125815 63871995
Disability 31.76 10.02 182 500740 11990 63985820
Arthritis infective 31.50 10.02 123 500799 6907 63990903
Faecal calprotectin increased 31.49 10.02 80 500842 3560 63994250
Intestinal resection 31.45 10.02 72 500850 2996 63994814
Hyperthermia 31.35 10.02 45 500877 15505 63982305
Myalgia 31.33 10.02 965 499957 157652 63840158
Neoplasm progression 31.26 10.02 188 500734 40776 63957034
Acute myeloid leukaemia 31.13 10.02 109 500813 27354 63970456
Hepatic encephalopathy 30.90 10.02 74 500848 20992 63976818
Off label use 30.72 10.02 4378 496544 628428 63369382
Blood bilirubin increased 30.68 10.02 292 500630 57261 63940549
Multiple fractures 30.66 10.02 110 500812 5930 63991880
Disorientation 30.30 10.02 282 500640 55546 63942264
Red blood cell count decreased 30.15 10.02 536 500386 47850 63949960
Cytomegalovirus viraemia 30.01 10.02 24 500898 10804 63987006
C-reactive protein increased 30.00 10.02 957 499965 93952 63903858
Hyperammonaemia 29.98 10.02 20 500902 9884 63987926
Blood creatinine increased 29.59 10.02 815 500107 134967 63862843
Pulmonary embolism 29.25 10.02 889 500033 145467 63852343
Skin papilloma 29.23 10.02 98 500824 5105 63992705
Blood glucose increased 29.16 10.02 561 500361 97512 63900298
Haemoglobin decreased 29.12 10.02 1821 499101 193242 63804568
Wheelchair user 28.96 10.02 91 500831 4581 63993229
Urticaria 28.91 10.02 897 500025 146420 63851390
Shock haemorrhagic 28.80 10.02 54 500868 16737 63981073
Hypertransaminasaemia 28.65 10.02 10 500912 7181 63990629
Bradyphrenia 28.47 10.02 19 500903 9387 63988423
Red blood cell sedimentation rate 28.44 10.02 78 500844 3636 63994174
Premature delivery 28.43 10.02 244 500678 18345 63979465
Anuria 28.31 10.02 66 500856 18898 63978912
Acute graft versus host disease in skin 28.24 10.02 9 500913 6846 63990964
Klebsiella infection 28.22 10.02 37 500885 13244 63984566
Tooth disorder 28.19 10.02 282 500640 22120 63975690
Limb deformity 28.18 10.02 73 500849 3288 63994522
Acidosis 28.15 10.02 60 500862 17735 63980075
Smear cervix abnormal 28.07 10.02 59 500863 2315 63995495
Alanine aminotransferase abnormal 28.06 10.02 117 500805 6771 63991039
Post procedural infection 28.06 10.02 148 500774 9449 63988361
Premature rupture of membranes 28.05 10.02 78 500844 3666 63994144
Respiratory disorder 27.94 10.02 165 500757 35946 63961864
Eosinophilia 27.88 10.02 177 500745 37899 63959911
Cyst 27.66 10.02 174 500748 11853 63985957
Premature labour 27.65 10.02 125 500797 7495 63990315
Interstitial lung disease 27.57 10.02 564 500358 97168 63900642
Adenovirus infection 27.38 10.02 11 500911 7244 63990566
Hepatitis B reactivation 27.36 10.02 3 500919 4886 63992924
Neutrophil count decreased 27.32 10.02 428 500494 76768 63921042
Mouth ulceration 27.30 10.02 378 500544 32066 63965744
Vitamin B12 deficiency 27.22 10.02 99 500823 5373 63992437
Blood cholesterol increased 27.20 10.02 543 500379 49523 63948287
Hypoaesthesia 27.12 10.02 1331 499591 137777 63860033
Burning sensation 27.10 10.02 539 500383 49125 63948685
Upper respiratory tract infection 27.10 10.02 749 500173 72036 63925774
Pancreatitis 27.06 10.02 314 500608 59293 63938517
Alanine aminotransferase increased 26.93 10.02 848 500074 138183 63859627
Polyneuropathy 26.78 10.02 73 500849 19821 63977989
Forced expiratory volume decreased 26.59 10.02 10 500912 6857 63990953
Nocardiosis 26.49 10.02 3 500919 4764 63993046
Metastases to liver 26.48 10.02 96 500826 23845 63973965
Latent tuberculosis 26.40 10.02 63 500859 2694 63995116
Pulmonary haemorrhage 26.36 10.02 38 500884 13071 63984739
Leukocytosis 26.34 10.02 178 500744 37562 63960248
No adverse event 26.30 10.02 123 500799 28438 63969372
Chronic graft versus host disease 26.29 10.02 8 500914 6268 63991542
Constipation 26.19 10.02 1485 499437 227852 63769958
Bone disorder 26.17 10.02 221 500701 16538 63981272
Blood test abnormal 25.98 10.02 181 500741 12762 63985048
Pemphigoid 25.77 10.02 38 500884 12948 63984862
Neck pain 25.74 10.02 643 500279 60890 63936920
Face oedema 25.63 10.02 102 500820 24659 63973151
Exposure to toxic agent 25.53 10.02 8 500914 6151 63991659
Pseudomonas infection 25.31 10.02 64 500858 17819 63979991
Malignant melanoma 25.27 10.02 180 500742 12784 63985026
Skin ulcer 25.26 10.02 481 500441 43493 63954317
Joint noise 25.15 10.02 68 500854 3143 63994667
Acute coronary syndrome 25.14 10.02 72 500850 19238 63978572
Pneumatosis intestinalis 25.14 10.02 5 500917 5224 63992586
Cyanosis 25.07 10.02 88 500834 22067 63975743
Stress cardiomyopathy 25.05 10.02 21 500901 9236 63988574
Electrocardiogram QRS complex prolonged 24.98 10.02 21 500901 9223 63988587
Potentiating drug interaction 24.95 10.02 15 500907 7837 63989973
Drug use disorder 24.85 10.02 8 500914 6046 63991764
Immunodeficiency 24.85 10.02 212 500710 15912 63981898
Drug ineffective for unapproved indication 24.76 10.02 141 500781 30992 63966818
Tenosynovitis stenosans 24.69 10.02 50 500872 1910 63995900
Kidney infection 24.64 10.02 229 500693 17609 63980201
Second primary malignancy 24.58 10.02 36 500886 12301 63985509
Metastases to lung 24.53 10.02 51 500871 15213 63982597
Gastrointestinal haemorrhage 24.43 10.02 812 500110 131500 63866310
Epstein-Barr virus infection 24.34 10.02 37 500885 12451 63985359
Pharyngitis streptococcal 24.21 10.02 132 500790 8536 63989274
Acute myocardial infarction 24.18 10.02 388 500534 69330 63928480
Withdrawal syndrome 24.18 10.02 97 500825 23395 63974415
Cystitis haemorrhagic 24.17 10.02 16 500906 7940 63989870
Emotional distress 24.15 10.02 172 500750 35866 63961944
Unintentional medical device removal 24.15 10.02 11 500911 6723 63991087
Full blood count decreased 24.09 10.02 275 500647 22307 63975503
Atrial fibrillation 23.92 10.02 1085 499837 170004 63827806
Oral herpes 23.74 10.02 270 500652 21882 63975928
Product dose omission issue 23.61 10.02 1787 499135 192960 63804850
Dry eye 23.57 10.02 336 500586 28683 63969127
Myelosuppression 23.52 10.02 100 500822 23730 63974080
Mobility decreased 23.45 10.02 851 500071 84989 63912821
Tardive dyskinesia 23.42 10.02 22 500900 9156 63988654
Restlessness 23.33 10.02 197 500725 39588 63958222
Increased tendency to bruise 23.25 10.02 137 500785 9118 63988692
Product administration error 23.18 10.02 123 500799 27520 63970290
Generalised tonic-clonic seizure 23.08 10.02 198 500724 39659 63958151
Wrong technique in product usage process 23.07 10.02 360 500562 64614 63933196
Clostridium difficile colitis 22.91 10.02 121 500801 27102 63970708
Incorrect route of product administration 22.85 10.02 98 500824 23200 63974610
Bone marrow failure 22.79 10.02 250 500672 47702 63950108
Renal injury 22.79 10.02 54 500868 15375 63982435
Myocardial ischaemia 22.69 10.02 98 500824 23153 63974657
Cystitis 22.57 10.02 461 500461 42214 63955596
Haemorrhage intracranial 22.50 10.02 102 500820 23782 63974028
Injection site warmth 22.35 10.02 180 500742 13282 63984528
Rotator cuff repair 22.26 10.02 41 500881 1458 63996352
Catatonia 22.25 10.02 16 500906 7604 63990206
Myopathy 22.24 10.02 67 500855 17613 63980197
Postoperative wound infection 22.21 10.02 147 500775 10189 63987621
Persecutory delusion 22.17 10.02 3 500919 4155 63993655
Pneumothorax 22.16 10.02 105 500817 24193 63973617
Cognitive disorder 22.08 10.02 298 500624 54789 63943021
Tubulointerstitial nephritis 21.96 10.02 145 500777 30764 63967046
Hypomagnesaemia 21.95 10.02 185 500737 37191 63960619
Metastases to bone 21.91 10.02 83 500839 20352 63977458
Cataract 21.83 10.02 537 500385 50725 63947085
Eye infection 21.80 10.02 135 500787 9146 63988664
Hepatic cytolysis 21.70 10.02 48 500874 14001 63983809
Gait disturbance 21.59 10.02 1584 499338 170571 63827239
Nephrolithiasis 21.51 10.02 467 500455 43216 63954594
Ulcer 21.48 10.02 273 500649 22717 63975093
Haemorrhage 21.47 10.02 461 500461 78890 63918920
Fear of injection 21.47 10.02 97 500825 5815 63991995
Tuberculosis 21.46 10.02 174 500748 12864 63984946
Cardiotoxicity 21.44 10.02 29 500893 10245 63987565
Hepatitis fulminant 21.36 10.02 11 500911 6263 63991547
Sudden death 21.30 10.02 82 500840 20014 63977796
Subdural haematoma 21.27 10.02 129 500793 27925 63969885
Loss of consciousness 21.13 10.02 939 499983 147426 63850384
Device use error 21.07 10.02 12 500910 6459 63991351
Transplant dysfunction 21.05 10.02 13 500909 6695 63991115
Cytomegalovirus chorioretinitis 21.05 10.02 6 500916 4906 63992904
Pulmonary oedema 21.02 10.02 458 500464 78216 63919594
Synovial fluid analysis 20.93 10.02 41 500881 1528 63996282
Hepatitis cholestatic 20.93 10.02 39 500883 12116 63985694
Hypoalbuminaemia 20.81 10.02 69 500853 17605 63980205
Acute respiratory failure 20.79 10.02 268 500654 49666 63948144
Headache 20.63 10.02 4529 496393 524938 63472872
Hyperlactacidaemia 20.61 10.02 6 500916 4838 63992972
Therapeutic reaction time decreased 20.54 10.02 46 500876 1886 63995924
Compartment syndrome 20.44 10.02 4 500918 4228 63993582
Temperature regulation disorder 20.30 10.02 4 500918 4207 63993603
Acute chest syndrome 20.29 10.02 30 500892 886 63996924
Loose body in joint 20.25 10.02 35 500887 1183 63996627
Transaminases increased 20.21 10.02 235 500687 44359 63953451
Dyspnoea 20.11 10.02 5117 495805 713557 63284253
Drug abuser 20.04 10.02 10 500912 5798 63992012
Peripheral sensory neuropathy 20.04 10.02 36 500886 11342 63986468
Nephrotic syndrome 19.97 10.02 27 500895 9540 63988270
Fracture delayed union 19.71 10.02 46 500876 1939 63995871
Hepatitis acute 19.67 10.02 47 500875 13342 63984468
Colitis ulcerative 19.66 10.02 269 500653 22759 63975051
Bronchospasm 19.60 10.02 94 500828 21588 63976222
Dermatitis acneiform 19.55 10.02 22 500900 8421 63989389
Ankylosing spondylitis 19.48 10.02 120 500802 8114 63989696
Respiratory acidosis 19.40 10.02 29 500893 9826 63987984
Coronary arterial stent insertion 19.35 10.02 10 500912 5682 63992128
Hypocalcaemia 19.32 10.02 219 500703 41534 63956276
Hyperprolactinaemia 19.31 10.02 4 500918 4061 63993749
Toxic encephalopathy 19.20 10.02 29 500893 9786 63988024
Product quality issue 19.12 10.02 144 500778 29655 63968155
Hyperuricaemia 19.09 10.02 31 500891 10160 63987650
Exostosis 19.02 10.02 153 500769 11285 63986525
Hernia 18.90 10.02 174 500748 13344 63984466
Inappropriate schedule of product administration 18.82 10.02 887 500035 91399 63906411
Polyhydramnios 18.81 10.02 38 500884 1449 63996361
Graft versus host disease in skin 18.77 10.02 9 500913 5338 63992472
Breast feeding 18.67 10.02 25 500897 672 63997138
Ingrown hair 18.63 10.02 23 500899 569 63997241
Enterocolitis 18.61 10.02 41 500881 11977 63985833
Sinus bradycardia 18.57 10.02 103 500819 22790 63975020
Pulmonary hypertension 18.53 10.02 230 500692 42909 63954901
Pulseless electrical activity 18.49 10.02 45 500877 12694 63985116
Cardiac failure acute 18.44 10.02 65 500857 16279 63981531
Sexual dysfunction 18.36 10.02 14 500908 6457 63991353
Progressive multifocal leukoencephalopathy 18.31 10.02 76 500846 18156 63979654
Therapeutic response decreased 18.30 10.02 533 500389 51655 63946155
Heart rate irregular 18.28 10.02 307 500615 27106 63970704
Nephropathy toxic 18.22 10.02 72 500850 17442 63980368
Adverse event 18.14 10.02 418 500504 39071 63958739
Hyperthyroidism 18.12 10.02 76 500846 18103 63979707
Cellulitis 18.01 10.02 895 500027 92762 63905048
Endodontic procedure 18.00 10.02 49 500873 2274 63995536
Maternal exposure timing unspecified 17.97 10.02 54 500868 2653 63995157
Intervertebral disc degeneration 17.90 10.02 168 500754 12952 63984858
Obstructive airways disorder 17.90 10.02 106 500816 23079 63974731
Hypercapnia 17.87 10.02 20 500902 7674 63990136
Blood parathyroid hormone decreased 17.84 10.02 108 500814 7258 63990552
Purging 17.74 10.02 8 500914 35 63997775
Scleritis 17.68 10.02 57 500865 2909 63994901
Bradypnoea 17.63 10.02 9 500913 5150 63992660
Nephrectomy 17.58 10.02 36 500886 1386 63996424
Bone density abnormal 17.51 10.02 54 500868 2691 63995119
Iodine allergy 17.40 10.02 21 500901 507 63997303
Endophthalmitis 17.40 10.02 10 500912 5355 63992455
Schizophrenia 17.38 10.02 38 500884 11130 63986680
Virologic failure 17.34 10.02 3 500919 3463 63994347
Metastases to central nervous system 17.30 10.02 53 500869 13859 63983951
Hepatocellular carcinoma 17.25 10.02 24 500898 8379 63989431
Acute pulmonary oedema 17.24 10.02 47 500875 12762 63985048
Hallucination 17.14 10.02 432 500490 72356 63925454
Tooth infection 17.04 10.02 181 500741 14420 63983390
Sleep disorder due to a general medical condition 17.03 10.02 116 500806 8118 63989692
Toothache 17.03 10.02 209 500713 17250 63980560
Haemodynamic instability 17.02 10.02 59 500863 14853 63982957
Pulmonary congestion 16.98 10.02 112 500810 23768 63974042
Lacrimal disorder 16.96 10.02 20 500902 471 63997339
Nasal congestion 16.92 10.02 594 500328 59064 63938746
Sensory loss 16.90 10.02 136 500786 10033 63987777
Blood iron decreased 16.83 10.02 156 500766 11986 63985824
Hypertriglyceridaemia 16.72 10.02 39 500883 11166 63986644
Antinuclear antibody positive 16.67 10.02 94 500828 6156 63991654
Heparin-induced thrombocytopenia 16.64 10.02 25 500897 8454 63989356
Purpura 16.64 10.02 73 500849 17173 63980637
Intestinal obstruction 16.63 10.02 384 500538 35902 63961908
Glycosylated haemoglobin increased 16.57 10.02 66 500856 15953 63981857
Blood lactic acid increased 16.51 10.02 35 500887 10366 63987444
Metabolic surgery 16.50 10.02 27 500895 872 63996938
Cardiac failure chronic 16.48 10.02 28 500894 9013 63988797
Foetal death 16.36 10.02 90 500832 5840 63991970
Cerebral haematoma 16.33 10.02 19 500903 7166 63990644
Mean cell volume increased 16.28 10.02 80 500842 4966 63992844
Aplasia 16.23 10.02 18 500904 6935 63990875
Multiple-drug resistance 16.11 10.02 16 500906 6486 63991324
Renal tubular necrosis 16.08 10.02 103 500819 22007 63975803
Anal fistula 16.04 10.02 82 500840 5171 63992639
Uterine perforation 16.00 10.02 13 500909 5807 63992003
Normal newborn 16.00 10.02 86 500836 5531 63992279
Knee operation 15.98 10.02 74 500848 4483 63993327
Haematocrit decreased 15.96 10.02 546 500376 54109 63943701
Kidney transplant rejection 15.95 10.02 31 500891 9480 63988330
Arthropod bite 15.93 10.02 98 500824 6623 63991187
Labelled drug-drug interaction medication error 15.93 10.02 103 500819 21959 63975851
Angina pectoris 15.93 10.02 250 500672 44831 63952979
Hepatitis C 15.91 10.02 39 500883 10976 63986834
Spinal osteoarthritis 15.91 10.02 176 500746 14165 63983645
Tonsillar inflammation 15.91 10.02 11 500911 124 63997686
Mass 15.83 10.02 185 500737 15091 63982719
Gingival pain 15.83 10.02 94 500828 6273 63991537
Alcohol abuse 15.80 10.02 9 500913 4843 63992967
Blood calcium decreased 15.68 10.02 125 500797 25429 63972381
Benign neoplasm of adrenal gland 15.64 10.02 7 500915 30 63997780
Osteonecrosis 15.57 10.02 142 500780 28087 63969723
Pneumonia bacterial 15.52 10.02 62 500860 14973 63982837
Chronic kidney disease 15.52 10.02 337 500585 57582 63940228
Blood folate increased 15.51 10.02 19 500903 466 63997344
Drug screen positive 15.50 10.02 13 500909 5716 63992094
Haematemesis 15.49 10.02 264 500658 46735 63951075
Synovial disorder 15.45 10.02 27 500895 921 63996889
Viral upper respiratory tract infection 15.40 10.02 113 500809 8102 63989708
Aspiration 15.38 10.02 73 500849 16812 63980998
Acute lymphocytic leukaemia recurrent 15.36 10.02 6 500916 4020 63993790
Intracranial pressure increased 15.34 10.02 19 500903 6970 63990840
Hydrocephalus 15.27 10.02 22 500900 7569 63990241
Spinal disorder 15.24 10.02 118 500804 8604 63989206
Atrioventricular block complete 15.18 10.02 59 500863 14359 63983451
Accidental death 15.15 10.02 5 500917 3720 63994090
Osteopenia 15.14 10.02 186 500736 15354 63982456
Dactylitis 15.14 10.02 41 500881 1897 63995913
Anhedonia 15.13 10.02 55 500867 13651 63984159
Complications of transplanted kidney 15.12 10.02 12 500910 5423 63992387
Oliguria 15.12 10.02 60 500862 14516 63983294
Therapeutic product effect incomplete 15.05 10.02 964 499958 102518 63895292
Sciatica 15.03 10.02 231 500691 20033 63977777
Tooth abscess 15.03 10.02 169 500753 13657 63984153
Bacteraemia 15.00 10.02 135 500787 26776 63971034
Hallucination, auditory 14.98 10.02 74 500848 16865 63980945
Induced labour 14.98 10.02 25 500897 821 63996989
Epstein-Barr virus associated lymphoproliferative disorder 14.96 10.02 3 500919 3116 63994694
Foetal distress syndrome 14.93 10.02 18 500904 434 63997376
Decreased appetite 14.90 10.02 1935 498987 279354 63718456
Rebound effect 14.79 10.02 10 500912 4907 63992903
Coronary artery bypass 14.77 10.02 14 500908 5801 63992009
Paranoia 14.71 10.02 71 500851 16281 63981529
Device difficult to use 14.71 10.02 34 500888 9764 63988046
Inflammatory bowel disease 14.68 10.02 72 500850 4466 63993344
Granuloma skin 14.67 10.02 89 500833 5985 63991825
Gastrooesophageal reflux disease 14.66 10.02 788 500134 82355 63915455
Pernicious anaemia 14.62 10.02 20 500902 549 63997261
Abortion incomplete 14.56 10.02 3 500919 3058 63994752
Alcohol interaction 14.56 10.02 8 500914 4393 63993417
Vitamin D decreased 14.56 10.02 106 500816 7581 63990229
Left ventricular dysfunction 14.46 10.02 75 500847 16879 63980931
Polyuria 14.45 10.02 50 500872 12593 63985217
Circulatory collapse 14.43 10.02 180 500742 33552 63964258
Acute graft versus host disease in intestine 14.41 10.02 5 500917 3604 63994206
Visual acuity reduced 14.34 10.02 138 500784 27003 63970807
Product administered to patient of inappropriate age 14.32 10.02 9 500913 4592 63993218
Lung transplant 14.29 10.02 7 500915 4101 63993709
Foot operation 14.28 10.02 68 500854 4167 63993643
Tremor 14.26 10.02 975 499947 147255 63850555
Vitamin B12 decreased 14.26 10.02 50 500872 2665 63995145
Acoustic neuroma 14.25 10.02 13 500909 224 63997586
Therapy partial responder 14.25 10.02 37 500885 10211 63987599
Musculoskeletal discomfort 14.25 10.02 191 500731 16086 63981724
Anaemia vitamin B12 deficiency 14.13 10.02 20 500902 567 63997243
Bursitis 14.10 10.02 240 500682 21245 63976565
Jaundice cholestatic 13.91 10.02 29 500893 8641 63989169
Akinesia 13.90 10.02 54 500868 3025 63994785
Joint lock 13.90 10.02 51 500871 2780 63995030
Injection site urticaria 13.71 10.02 140 500782 11041 63986769
Gastric haemorrhage 13.66 10.02 56 500866 13425 63984385
Skin laceration 13.66 10.02 266 500656 24151 63973659
Skin fissures 13.58 10.02 131 500791 10175 63987635
Cholangitis 13.54 10.02 41 500881 10761 63987049
Cytopenia 13.45 10.02 68 500854 15403 63982407
Sinus congestion 13.44 10.02 181 500741 15258 63982552
Anxiety 13.44 10.02 1373 499549 201276 63796534
Intervertebral disc protrusion 13.42 10.02 226 500696 19965 63977845
Joint dislocation 13.32 10.02 142 500780 11323 63986487
Deep vein thrombosis 13.32 10.02 674 500248 104508 63893302
Lipase increased 13.27 10.02 62 500860 14340 63983470
Oxygen saturation decreased 13.23 10.02 985 499937 106191 63891619
Haemodialysis 13.23 10.02 78 500844 16999 63980811
Placental disorder 13.18 10.02 24 500898 846 63996964
Human antichimeric antibody positive 13.18 10.02 32 500890 1384 63996426
Parkinsonism 13.17 10.02 62 500860 14311 63983499
Hyperpyrexia 13.16 10.02 12 500910 5065 63992745
Congestive cardiomyopathy 13.15 10.02 39 500883 10305 63987505
Dyslipidaemia 13.14 10.02 33 500889 9209 63988601
Limb injury 13.12 10.02 256 500666 23249 63974561
Hiatus hernia 13.12 10.02 223 500699 19734 63978076
Arthritis bacterial 13.11 10.02 105 500817 7734 63990076
Haemorrhage in pregnancy 13.08 10.02 30 500892 1250 63996560
Hypotonia 13.04 10.02 44 500878 11168 63986642
Spinal operation 13.04 10.02 87 500835 6046 63991764
Osteoporotic fracture 13.04 10.02 59 500863 3539 63994271
Tooth fracture 12.99 10.02 126 500796 9801 63988009
Disturbance in social behaviour 12.96 10.02 7 500915 3880 63993930
Metastases to meninges 12.90 10.02 3 500919 2812 63994998
Ileus 12.90 10.02 115 500807 22851 63974959
On and off phenomenon 12.89 10.02 46 500876 2473 63995337
Oedema 12.85 10.02 583 500339 91352 63906458
Strongyloidiasis 12.83 10.02 4 500918 3086 63994724
Aphthous ulcer 12.81 10.02 155 500767 12751 63985059
Disease recurrence 12.79 10.02 170 500752 31340 63966470
Panniculitis 12.78 10.02 115 500807 8764 63989046
Injection site haemorrhage 12.75 10.02 262 500660 24016 63973794
Ketoacidosis 12.74 10.02 21 500901 6842 63990968
Stillbirth 12.74 10.02 59 500863 3574 63994236
Lupus-like syndrome 12.72 10.02 114 500808 8677 63989133
Haematoma 12.71 10.02 268 500654 45982 63951828
Psychomotor skills impaired 12.71 10.02 7 500915 3838 63993972
Squamous cell carcinoma 12.66 10.02 164 500758 13705 63984105
Delivery 12.60 10.02 18 500904 515 63997295
Stress 12.59 10.02 583 500339 59951 63937859
Polydipsia 12.59 10.02 16 500906 5805 63992005
Malaise 12.59 10.02 3359 497563 392888 63604922
Skin infection 12.57 10.02 175 500747 14862 63982948
Benign abdominal neoplasm 12.56 10.02 12 500910 220 63997590
Epilepsy 12.51 10.02 184 500738 33347 63964463
Rheumatoid lung 12.46 10.02 45 500877 2434 63995376
COVID-19 pneumonia 12.46 10.02 76 500846 16428 63981382
Hypoglycaemic coma 12.45 10.02 9 500913 4265 63993545
Capillary leak syndrome 12.44 10.02 5 500917 3292 63994518
Immunosuppression 12.44 10.02 133 500789 10613 63987197
Dyskinesia 12.42 10.02 223 500699 39165 63958645
Muscle rigidity 12.40 10.02 82 500840 17391 63980419
Antibody test positive 12.36 10.02 44 500878 2363 63995447
Fungaemia 12.35 10.02 7 500915 3778 63994032
Dysstasia 12.35 10.02 251 500671 22964 63974846
Hepatitis B 12.34 10.02 26 500896 7719 63990091
Affective disorder 12.34 10.02 20 500902 6560 63991250
Angina unstable 12.32 10.02 70 500852 15397 63982413
Sickle cell anaemia 12.32 10.02 19 500903 583 63997227
Accidental exposure to product 12.31 10.02 138 500784 26226 63971584
Pseudomembranous colitis 12.29 10.02 12 500910 4904 63992906
Hepatic necrosis 12.24 10.02 30 500892 8443 63989367
Back disorder 12.20 10.02 125 500797 9865 63987945
Mitochondrial toxicity 12.18 10.02 3 500919 2703 63995107
Granulocytopenia 12.13 10.02 41 500881 10399 63987411
Joint warmth 12.12 10.02 31 500891 1385 63996425
Hypernatraemia 12.12 10.02 51 500871 12138 63985672
Hallucination, visual 12.10 10.02 148 500774 27686 63970124
Muscle twitching 12.09 10.02 92 500830 18906 63978904
Throat lesion 12.08 10.02 13 500909 276 63997534
Human herpesvirus 6 infection 12.06 10.02 11 500911 4643 63993167
Type 1 diabetes mellitus 12.01 10.02 16 500906 5689 63992121
Anticholinergic syndrome 11.93 10.02 3 500919 2666 63995144
Bacterial sepsis 11.91 10.02 25 500897 7432 63990378
Medication error 11.91 10.02 296 500626 49670 63948140
Impaired work ability 11.88 10.02 175 500747 15044 63982766
Lower respiratory tract congestion 11.83 10.02 50 500872 2911 63994899
Acrochordon 11.80 10.02 23 500899 854 63996956
Blood urea increased 11.80 10.02 257 500665 43896 63953914
Dermatitis exfoliative 11.79 10.02 41 500881 10311 63987499
Benign ovarian tumour 11.75 10.02 13 500909 285 63997525
Musculoskeletal disorder 11.74 10.02 200 500722 17706 63980104
Cervical incompetence 11.68 10.02 17 500905 495 63997315
Haematuria 11.66 10.02 369 500553 60102 63937708
Placental insufficiency 11.65 10.02 25 500897 995 63996815
Dermatitis bullous 11.64 10.02 51 500871 12003 63985807
Blood iron increased 11.64 10.02 30 500892 1347 63996463
Wound infection 11.63 10.02 171 500751 14693 63983117
Rash erythematous 11.62 10.02 288 500634 48345 63949465
Pneumomediastinum 11.61 10.02 4 500918 2896 63994914
Small intestinal obstruction 11.60 10.02 252 500670 23321 63974489
Gestational hypertension 11.60 10.02 34 500888 1647 63996163
Red blood cell count 11.60 10.02 3 500919 0 63997810
Vasa praevia 11.60 10.02 3 500919 0 63997810
Lymphatic fistula 11.60 10.02 21 500901 737 63997073
Pulmonary tuberculosis 11.56 10.02 96 500826 7148 63990662
Femoral hernia incarcerated 11.54 10.02 21 500901 740 63997070
Polyp 11.50 10.02 90 500832 6583 63991227
Portal vein cavernous transformation 11.47 10.02 4 500918 7 63997803
Liver transplant 11.43 10.02 9 500913 4083 63993727
Ileal stenosis 11.42 10.02 39 500883 2051 63995759
Hypoxic-ischaemic encephalopathy 11.41 10.02 24 500898 7128 63990682
Fistula 11.39 10.02 121 500801 9640 63988170
Sleep apnoea syndrome 11.38 10.02 308 500614 29524 63968286
Abortion threatened 11.35 10.02 15 500907 398 63997412
Metabolic disorder 11.32 10.02 27 500895 7670 63990140
Chondropathy 11.27 10.02 42 500880 2307 63995503
Candida infection 11.18 10.02 174 500748 31245 63966565
Abscess intestinal 11.16 10.02 42 500880 2318 63995492
Chronic disease 11.15 10.02 8 500914 96 63997714
Hypertonia 11.15 10.02 20 500902 6305 63991505
Malignant mediastinal neoplasm 11.13 10.02 17 500905 517 63997293
Genital haemorrhage 11.11 10.02 16 500906 5506 63992304
Clavicle fracture 11.09 10.02 58 500864 3691 63994119
Limb discomfort 11.07 10.02 283 500639 26892 63970918
Oculogyric crisis 11.06 10.02 3 500919 2535 63995275
Immunosuppressant drug level increased 11.05 10.02 25 500897 7234 63990576
Right ventricular failure 10.99 10.02 110 500812 21361 63976449
Metastases to lymph nodes 10.99 10.02 33 500889 8684 63989126
Upper respiratory tract inflammation 10.97 10.02 8 500914 3774 63994036
Perirectal abscess 10.95 10.02 35 500887 1778 63996032
Fluid retention 10.95 10.02 366 500556 59240 63938570
End stage renal disease 10.94 10.02 43 500879 10432 63987378
Nerve compression 10.92 10.02 97 500825 7364 63990446
Ventricular arrhythmia 10.91 10.02 26 500896 7389 63990421
Body height below normal 10.89 10.02 35 500887 1783 63996027
Dental caries 10.84 10.02 130 500792 10670 63987140
Gastrointestinal stoma complication 10.84 10.02 40 500882 2186 63995624
Ventricular hypokinesia 10.84 10.02 28 500894 7741 63990069
Accessory spleen 10.84 10.02 10 500912 175 63997635
Oesophageal fibrosis 10.79 10.02 10 500912 176 63997634
Device related infection 10.76 10.02 170 500752 30456 63967354
Pancreatic steatosis 10.72 10.02 24 500898 984 63996826
Cushingoid 10.70 10.02 98 500824 7505 63990305
Tendon disorder 10.69 10.02 85 500837 6247 63991563
Cryptococcosis 10.69 10.02 4 500918 2751 63995059
Skin ulcer haemorrhage 10.69 10.02 16 500906 478 63997332
Palindromic rheumatism 10.67 10.02 13 500909 317 63997493
Wrong product administered 10.64 10.02 28 500894 7692 63990118
Small for dates baby 10.63 10.02 15 500907 424 63997386
Hernia pain 10.61 10.02 15 500907 425 63997385
Bundle branch block left 10.60 10.02 41 500881 9993 63987817
Menstruation delayed 10.58 10.02 26 500896 1133 63996677
Wound infection pseudomonas 10.57 10.02 31 500891 1502 63996308
Copper deficiency 10.56 10.02 8 500914 105 63997705
Acute lung injury 10.54 10.02 4 500918 2727 63995083
Human anti-human antibody test 10.52 10.02 14 500908 374 63997436
Stoma site erythema 10.48 10.02 27 500895 1212 63996598
Maternal exposure during breast feeding 10.48 10.02 37 500885 1979 63995831
Intestinal ischaemia 10.48 10.02 50 500872 11499 63986311
Neuralgia 10.47 10.02 272 500650 25912 63971898
Body temperature fluctuation 10.44 10.02 52 500870 3246 63994564
Cholecystitis chronic 10.43 10.02 37 500885 9250 63988560
Dislocation of vertebra 10.42 10.02 50 500872 3074 63994736
Threatened labour 10.41 10.02 17 500905 548 63997262
Product prescribing error 10.40 10.02 202 500720 35067 63962743
Pain in jaw 10.39 10.02 239 500683 40516 63957294
Injection site discolouration 10.39 10.02 90 500832 6785 63991025
Metamyelocyte count increased 10.36 10.02 18 500904 611 63997199
Vascular rupture 10.36 10.02 28 500894 1294 63996516
Skin abrasion 10.34 10.02 137 500785 11508 63986302
Cytomegalovirus infection reactivation 10.33 10.02 18 500904 5738 63992072
Failed induction of labour 10.32 10.02 11 500911 231 63997579
Illness 10.32 10.02 233 500689 21705 63976105
C-reactive protein decreased 10.29 10.02 38 500884 2078 63995732
Rash morbilliform 10.24 10.02 15 500907 5126 63992684
Muscle strain 10.24 10.02 103 500819 8091 63989719
Adjustment disorder with depressed mood 10.22 10.02 42 500880 2415 63995395
Stoma site inflammation 10.21 10.02 17 500905 557 63997253
Colitis microscopic 10.21 10.02 27 500895 7405 63990405
Extradural haematoma 10.19 10.02 4 500918 2672 63995138
Pneumocystis jirovecii pneumonia 10.19 10.02 152 500770 27482 63970328
Ejection fraction abnormal 10.16 10.02 29 500893 1384 63996426
Tuberculin test positive 10.16 10.02 49 500873 3019 63994791
Hysterectomy 10.14 10.02 71 500851 5014 63992796
Cartilage injury 10.13 10.02 28 500894 1311 63996499
Personality disorder 10.12 10.02 67 500855 4644 63993166
Ankle arthroplasty 10.12 10.02 22 500900 884 63996926
Foreign body in reproductive tract 10.07 10.02 15 500907 446 63997364
Abdominal adhesions 10.06 10.02 48 500874 2944 63994866

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B03AE01 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
IRON PREPARATIONS
Iron in other combinations
ATC B03BA01 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
VITAMIN B12 AND FOLIC ACID
Vitamin B12 (cyanocobalamin and analogues)
ATC B03BA51 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
VITAMIN B12 AND FOLIC ACID
Vitamin B12 (cyanocobalamin and analogues)
FDA CS M0022794 Vitamin B 12
MeSH PA D018977 Micronutrients
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
FDA EPC N0000175951 Vitamin B12
CHEBI has role CHEBI:33229 vitamins

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

DiseaseRelationSNOMED_IDDOID
Pernicious anemia indication 84027009 DOID:13381
Megaloblastic anemia due to folate deficiency indication 85649008 DOID:14026
Vitamin deficiency indication 85670002
Iron deficiency anemia indication 87522002
Cobalamin deficiency indication 190634004
Prevention of Vitamin B12 Deficiency indication
Vitamin Deficiency Prevention indication
Homocystinuria off-label use 11282001 DOID:9263
Methylmalonic acidemia off-label use 42393006
Homocystinemia off-label use 52311001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.5MG/SPRAY NASCOBAL ENDO PHARMS INC N021642 Jan. 31, 2005 RX SPRAY, METERED NASAL 8940714 Feb. 26, 2024 CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION
0.5MG/SPRAY NASCOBAL ENDO PHARMS INC N021642 Jan. 31, 2005 RX SPRAY, METERED NASAL 9415007 July 28, 2024 SUPPLEMENT FOR VITAMIN B12 DEFICIENCIES
0.5MG/SPRAY NASCOBAL ENDO PHARMS INC N021642 Jan. 31, 2005 RX SPRAY, METERED NASAL 7229636 Aug. 1, 2024 NASAL ADMINISTRATION OF CYANOCOBALAMIN
0.5MG/SPRAY NASCOBAL ENDO PHARMS INC N021642 Jan. 31, 2005 RX SPRAY, METERED NASAL 7879349 Aug. 1, 2024 CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION
0.5MG/SPRAY NASCOBAL ENDO PHARMS INC N021642 Jan. 31, 2005 RX SPRAY, METERED NASAL 8003353 Aug. 1, 2024 NASAL ADMINISTRATION OF CYANOCOBALAMIN

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Methionine synthase Enzyme WOMBAT-PK
Methionine synthase reductase Enzyme WOMBAT-PK
Protein amnionless Unclassified WOMBAT-PK
Cob(I)yrinic acid a,c-diamide adenosyltransferase, mitochondrial Enzyme WOMBAT-PK
Methylmalonic aciduria type A protein, mitochondrial Enzyme WOMBAT-PK
Transcobalamin-2 Secreted WOMBAT-PK
Transcobalamin-1 Secreted WOMBAT-PK

External reference:

IDSource
4021085 VUID
N0000148543 NUI
D00166 KEGG_DRUG
4017441 VANDF
4021085 VANDF
4021896 VANDF
C0042845 UMLSCUI
CHEBI:17439 CHEBI
CNC PDB_CHEM_ID
CHEMBL2110563 ChEMBL_ID
CHEMBL2375172 ChEMBL_ID
DB00115 DRUGBANK_ID
1369 INN_ID
P6YC3EG204 UNII
54605677 PUBCHEM_CID
11248 RXNORM
213062 MMSL
257021 MMSL
4514 MMSL
5682 MMSL
6832 MMSL
6837 MMSL
8312 MMSL
d00413 MMSL
001043 NDDF
30010009 SNOMEDCT_US
419382002 SNOMEDCT_US
D014805 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9619 INJECTION 1000 ug INTRAMUSCULAR ANDA 21 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9620 INJECTION 1000 ug INTRAMUSCULAR ANDA 21 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9621 INJECTION 1000 ug INTRAMUSCULAR ANDA 21 sections
Ferralet 90 HUMAN PRESCRIPTION DRUG LABEL 5 0178-0089 TABLET, FILM COATED 12 ug ORAL unapproved drug other 17 sections
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 12 ug ORAL Unapproved drug other 12 sections
CitraNatal Bloom HUMAN PRESCRIPTION DRUG LABEL 6 0178-0813 TABLET, FILM COATED 16.80 ug ORAL unapproved drug other 15 sections
CYANOCOBALAMIN HUMAN PRESCRIPTION DRUG LABEL 1 0404-9840 INJECTION 1000 ug INTRAMUSCULAR ANDA 11 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0031 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0031 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0032 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0032 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0130 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
Cyanocobalamin HUMAN PRESCRIPTION DRUG LABEL 1 0517-0130 INJECTION, SOLUTION 1000 ug INTRAMUSCULAR ANDA 19 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 0.01 mg ORAL unapproved drug other 14 sections
Vitafol Caplet HUMAN PRESCRIPTION DRUG LABEL 12 0642-0072 CAPSULE 5 ug ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 12 ug ORAL Unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 12 ug ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 12 ug ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 12 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Strovite Forte Caplet HUMAN PRESCRIPTION DRUG LABEL 19 0642-0204 TABLET, COATED 50 ug ORAL UNAPPROVED DRUG OTHER 15 sections
Strovite One Caplets HUMAN PRESCRIPTION DRUG LABEL 20 0642-0207 TABLET 50 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Reaphirm Plant Source DHA HUMAN PRESCRIPTION DRUG LABEL 16 0642-3010 CAPSULE, GELATIN COATED 0.01 mg ORAL unapproved drug other 7 sections
Vitafol HUMAN PRESCRIPTION DRUG LABEL 4 0642-7468 STRIP 12 ug ORAL Unapproved drug other 13 sections
Vitafol Fe Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-7473 CAPSULE, LIQUID FILLED 25 ug ORAL UNAPPROVED DRUG OTHER 14 sections
Marnatal F HUMAN PRESCRIPTION DRUG LABEL 13 0682-1570 CAPSULE 12 ug ORAL UNAPPROVED DRUG OTHER 4 sections
BACMIN HUMAN PRESCRIPTION DRUG LABEL 19 0682-3001 TABLET, COATED 50 ug ORAL UNAPPROVED DRUG OTHER 10 sections
O-Cal Prenatal Vitamin HUMAN PRESCRIPTION DRUG LABEL 16 0813-0202 TABLET 12 ug ORAL UNAPPROVED DRUG OTHER 6 sections
PRENATAL PLUS HUMAN PRESCRIPTION DRUG LABEL 15 10544-549 TABLET, FILM COATED 12 ug ORAL unapproved drug other 8 sections
PRENATAL PLUS IRON HUMAN PRESCRIPTION DRUG LABEL 15 10544-609 TABLET, FILM COATED 12 ug ORAL UNAPPROVED DRUG OTHER 7 sections
Se-Natal 19 HUMAN PRESCRIPTION DRUG LABEL 15 13925-116 TABLET 12 ug ORAL unapproved drug other 15 sections