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

Stem definitionDrug idCAS RN
2836 65-23-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pyridoxine
  • adermin
  • bezatin
  • pirivitol
  • pyridoxin
  • pyridoxine hydrochloride
  • pyridoxine (vit B6)
  • vitamin b6
  • pyridoxine HCl
The 4-methanol form of VITAMIN B 6 which is converted to PYRIDOXAL PHOSPHATE which is a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. Although pyridoxine and Vitamin B 6 are still frequently used as synonyms, especially by medical researchers, this practice is erroneous and sometimes misleading (EE Snell; Ann NY Acad Sci, vol 585 pg 1, 1990).
  • Molecular weight: 169.18
  • Formula: C8H11NO3
  • CLOGP: -0.34
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 73.58
  • ALOGS: -1.02
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.16 g O
0.16 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 222 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 39.43 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.66 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.90 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.98 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA HOSPIRA

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 1681.52 10.18 4403 544539 179323 62760757
Systemic lupus erythematosus 1597.83 10.18 4689 544253 204229 62735851
Glossodynia 1405.93 10.18 4055 544887 174821 62765259
Hand deformity 1139.74 10.18 3496 545446 155961 62784119
Arthropathy 1060.63 10.18 4428 544514 230364 62709716
Abdominal discomfort 1005.90 10.18 5443 543499 315442 62624638
Completed suicide 997.26 10.18 67 548875 145606 62794474
Alopecia 981.25 10.18 5610 543332 331926 62608154
Wound 945.50 10.18 3333 545609 159930 62780150
Maternal exposure during pregnancy 860.94 10.18 3976 544966 216086 62723994
Rheumatoid arthritis 839.54 10.18 4371 544571 249448 62690632
Toxicity to various agents 766.20 10.18 609 548333 246641 62693439
Synovitis 739.55 10.18 3389 545553 183529 62756551
Anti-cyclic citrullinated peptide antibody positive 711.12 10.18 2417 546525 113795 62826285
Discomfort 705.89 10.18 3093 545849 164281 62775799
Pericarditis 704.43 10.18 2619 546323 128960 62811120
Swelling 699.74 10.18 4421 544521 270957 62669123
Contraindicated product administered 661.42 10.18 3663 545279 213985 62726095
Infusion related reaction 638.72 10.18 3966 544976 241555 62698525
Joint swelling 621.01 10.18 4899 544043 322767 62617313
Pain 555.80 10.18 9231 539711 731397 62208683
Death 495.91 10.18 1623 547319 372758 62567322
Duodenal ulcer perforation 445.86 10.18 1711 547231 85498 62854582
Rheumatoid factor positive 437.26 10.18 1663 547279 82743 62857337
Helicobacter infection 432.95 10.18 1769 547173 91016 62849064
Intentional overdose 427.66 10.18 65 548877 74087 62865993
Product use issue 423.13 10.18 3308 545634 217212 62722868
Drug interaction 411.34 10.18 852 548090 228279 62711801
Drug abuse 397.30 10.18 73 548869 72445 62867635
Hepatic enzyme increased 385.26 10.18 3030 545912 199298 62740782
Arthralgia 361.06 10.18 6918 542024 562792 62377288
Psoriatic arthropathy 329.79 10.18 1616 547326 89904 62850176
Musculoskeletal stiffness 312.78 10.18 2693 546249 181925 62758155
Therapeutic product effect decreased 299.53 10.18 2764 546178 190423 62749657
Exposure during pregnancy 295.69 10.18 2329 546613 153218 62786862
Febrile neutropenia 288.16 10.18 360 548582 118089 62821991
Drug intolerance 279.81 10.18 3977 544965 304684 62635396
Suicide attempt 260.73 10.18 100 548842 60818 62879262
Cardiac arrest 256.13 10.18 253 548689 92292 62847788
Depressed level of consciousness 252.55 10.18 110 548832 61968 62878112
Treatment failure 247.86 10.18 2722 546220 196321 62743759
Overdose 244.78 10.18 385 548557 114693 62825387
Acute kidney injury 238.37 10.18 1320 547622 262095 62677985
Hip arthroplasty 235.40 10.18 925 548017 46721 62893359
Knee arthroplasty 228.29 10.18 1002 547940 53204 62886876
Hypersensitivity 215.32 10.18 3641 545301 289044 62651036
Rheumatic fever 195.49 10.18 815 548127 42296 62897784
Malignant neoplasm progression 192.05 10.18 257 548685 81864 62858216
Nasopharyngitis 188.77 10.18 3168 545774 251089 62688991
Impaired healing 187.43 10.18 1522 547420 101020 62839060
Disease progression 185.32 10.18 500 548442 122258 62817822
Sedation 175.81 10.18 58 548884 38751 62901329
Swollen joint count increased 170.90 10.18 691 548251 35363 62904717
Neutropenia 170.47 10.18 855 548087 174150 62765930
Lactic acidosis 163.58 10.18 63 548879 38224 62901856
Bradycardia 161.44 10.18 239 548703 72988 62867092
Hyponatraemia 157.68 10.18 471 548471 111429 62828651
Blister 156.76 10.18 1765 547177 128049 62812031
Red blood cell sedimentation rate abnormal 156.42 10.18 450 548492 19332 62920748
Folliculitis 154.53 10.18 1090 547852 69227 62870853
Fatigue 150.95 10.18 9238 539704 878790 62061290
Muscle injury 150.71 10.18 1025 547917 64320 62875760
Constipation 149.50 10.18 1235 547707 223708 62716372
Hypotension 143.21 10.18 1586 547356 271018 62669062
Cardiac failure 142.25 10.18 353 548589 88789 62851291
Nausea 139.72 10.18 6007 542935 848464 62091616
Respiratory arrest 135.73 10.18 56 548886 32589 62907491
Sickle cell anaemia with crisis 135.45 10.18 210 548732 5793 62934287
Drug hypersensitivity 134.14 10.18 1885 547057 308802 62631278
Sleep disorder due to general medical condition, insomnia type 133.15 10.18 840 548102 51377 62888703
Somnolence 130.40 10.18 956 547986 177729 62762351
Rash 129.98 10.18 6009 542933 554862 62385218
Agitation 129.82 10.18 197 548745 59560 62880520
Electrocardiogram QT prolonged 127.65 10.18 198 548744 59332 62880748
Sopor 126.47 10.18 20 548922 22144 62917936
Renal failure 126.18 10.18 555 548387 117097 62822983
Rhabdomyolysis 125.25 10.18 117 548825 43834 62896246
Irritable bowel syndrome 122.95 10.18 1170 547772 81242 62858838
Hyperhidrosis 122.86 10.18 497 548445 107339 62832741
Drug reaction with eosinophilia and systemic symptoms 119.66 10.18 72 548870 33764 62906316
C-reactive protein abnormal 119.06 10.18 744 548198 45352 62894728
Cardio-respiratory arrest 115.16 10.18 214 548728 59745 62880335
Intentional self-injury 113.56 10.18 40 548902 25647 62914433
Blood cholesterol increased 113.25 10.18 1278 547664 92754 62847326
Osteoarthritis 111.31 10.18 1288 547654 94055 62846025
Diarrhoea 109.96 10.18 5062 543880 710304 62229776
Lower respiratory tract infection 109.84 10.18 1680 547262 130627 62809453
Anxiety 106.66 10.18 1285 547657 216256 62723824
Tremor 104.57 10.18 691 548251 131548 62808532
Syncope 103.97 10.18 592 548350 116793 62823287
Neoplasm progression 103.77 10.18 97 548845 36331 62903749
Pregnancy 103.69 10.18 608 548334 36228 62903852
Tachycardia 103.52 10.18 598 548344 117558 62822522
Asthenia 102.00 10.18 2531 546411 381073 62559007
Dyspnoea 101.06 10.18 4682 544260 656631 62283449
Arthritis 100.91 10.18 1484 547458 114437 62825643
Hypoglycaemia 100.46 10.18 232 548710 59833 62880247
Vomiting 100.34 10.18 3891 545051 555726 62384354
Liver injury 98.76 10.18 876 548066 59644 62880436
Coma 96.46 10.18 263 548679 64101 62875979
Psoriasis 96.33 10.18 1163 547779 85794 62854286
Cognitive disorder 93.82 10.18 215 548727 55600 62884480
Type 2 diabetes mellitus 92.92 10.18 902 548040 62966 62877114
No adverse event 92.36 10.18 134 548808 41271 62898809
Thrombocytopenia 90.60 10.18 852 548090 150305 62789775
Intentional product use issue 89.84 10.18 1580 547362 126312 62813768
Metabolic acidosis 89.10 10.18 158 548784 44911 62895169
Condition aggravated 88.43 10.18 4288 544654 397929 62542151
Serotonin syndrome 88.22 10.18 71 548871 28611 62911469
Abortion spontaneous 88.08 10.18 704 548238 46491 62893589
Fibromyalgia 87.09 10.18 1071 547871 79349 62860731
Intentional product misuse 86.08 10.18 256 548686 60661 62879419
Drug dependence 85.31 10.18 53 548889 24430 62915650
Sedation complication 84.71 10.18 10 548932 13812 62926268
Renal impairment 82.95 10.18 437 548505 87918 62852162
Asthma 82.12 10.18 706 548236 126855 62813225
Peripheral swelling 81.08 10.18 2935 546007 263007 62677073
Angioedema 80.43 10.18 185 548757 47780 62892300
Live birth 80.03 10.18 435 548507 25195 62914885
Multiple organ dysfunction syndrome 79.11 10.18 240 548702 56512 62883568
Hyperglycaemia 77.27 10.18 153 548789 41714 62898366
Joint effusion 76.92 10.18 322 548620 16738 62923342
Orthostatic hypotension 75.87 10.18 122 548820 36038 62904042
Hepatic function abnormal 74.52 10.18 129 548813 37013 62903067
Drug withdrawal syndrome 74.45 10.18 75 548867 27119 62912961
Drug resistance 74.07 10.18 54 548888 22879 62917201
Altered state of consciousness 73.26 10.18 66 548876 25164 62914916
Anaemia 72.87 10.18 1955 546987 291475 62648605
Ill-defined disorder 72.86 10.18 1051 547891 80704 62859376
Respiratory failure 72.80 10.18 548 548394 101310 62838770
Multiple sclerosis relapse 72.70 10.18 198 548744 48280 62891800
Contusion 72.52 10.18 1754 547188 148290 62791790
Myalgia 72.36 10.18 864 548078 145665 62794415
Product quality issue 71.56 10.18 125 548817 35740 62904340
Hyperkalaemia 71.49 10.18 235 548707 53968 62886112
Hepatic failure 71.39 10.18 124 548818 35532 62904548
Dizziness 71.20 10.18 3016 545926 426909 62513171
Hepatocellular injury 71.06 10.18 79 548863 27302 62912778
Creatinine renal clearance decreased 71.06 10.18 26 548916 16282 62923798
Anaphylactic reaction 70.73 10.18 312 548630 65788 62874292
Hallucination 70.69 10.18 240 548702 54577 62885503
Blood pressure diastolic abnormal 69.93 10.18 280 548662 14262 62925818
Cytomegalovirus infection 69.42 10.18 48 548894 20904 62919176
Blood pressure fluctuation 68.78 10.18 657 548285 45660 62894420
Blood pressure systolic abnormal 68.63 10.18 263 548679 13123 62926957
Device expulsion 68.51 10.18 123 548819 34799 62905281
Cardiac failure congestive 67.63 10.18 494 548448 91939 62848141
Blood glucose increased 67.54 10.18 435 548507 83321 62856759
Cholestasis 66.90 10.18 94 548848 29340 62910740
Drug ineffective 66.20 10.18 10139 538803 1034626 61905454
Foot deformity 66.05 10.18 440 548502 27413 62912667
Encephalopathy 65.53 10.18 148 548794 38472 62901608
Balance disorder 65.28 10.18 444 548498 83978 62856102
Disability assessment scale score increased 64.58 10.18 107 548835 3126 62936954
Drug ineffective for unapproved indication 64.15 10.18 123 548819 33940 62906140
Myocardial infarction 63.78 10.18 554 548388 99339 62840741
Metastases to bone 63.44 10.18 53 548889 20966 62919114
Chest discomfort 63.26 10.18 626 548316 109343 62830737
Macular degeneration 62.53 10.18 71 548871 24305 62915775
Seizure 62.48 10.18 790 548152 131844 62808236
Hypoxia 62.31 10.18 285 548657 59507 62880573
Sinusitis 62.26 10.18 2473 546469 224180 62715900
Red blood cell sedimentation rate increased 60.97 10.18 615 548327 43367 62896713
Shock 60.56 10.18 68 548874 23395 62916685
Anaphylactic shock 60.44 10.18 69 548873 23564 62916516
Dehydration 60.23 10.18 1095 547847 172259 62767821
Vision blurred 58.15 10.18 511 548431 91413 62848667
Basal cell carcinoma 58.06 10.18 428 548514 27563 62912517
Suicidal ideation 57.88 10.18 310 548632 62111 62877969
Poisoning 57.76 10.18 23 548919 13677 62926403
Leukopenia 57.06 10.18 412 548530 76878 62863202
Loss of consciousness 56.97 10.18 700 548242 117421 62822659
Feeling abnormal 56.49 10.18 922 548020 147470 62792610
Osteonecrosis of jaw 56.08 10.18 139 548803 34984 62905096
Mydriasis 55.69 10.18 17 548925 11939 62928141
Cytokine release syndrome 55.66 10.18 27 548915 14287 62925793
Ejection fraction decreased 55.19 10.18 67 548875 22265 62917815
Disseminated intravascular coagulation 55.12 10.18 50 548892 19001 62921079
Blood creatine phosphokinase increased 54.62 10.18 113 548829 30317 62909763
Neutrophil count decreased 54.61 10.18 276 548666 56130 62883950
Product use in unapproved indication 54.39 10.18 1157 547785 177923 62762157
Injection site erythema 54.32 10.18 1016 547926 82158 62857922
Gamma-glutamyltransferase increased 54.08 10.18 135 548807 33896 62906184
Tuberculosis 54.02 10.18 216 548726 10995 62929085
Ventricular tachycardia 53.67 10.18 56 548886 19923 62920157
Juvenile idiopathic arthritis 53.39 10.18 100 548842 3226 62936854
Pulmonary fibrosis 52.96 10.18 552 548390 39257 62900823
COVID-19 52.77 10.18 675 548267 112428 62827652
Disorientation 52.75 10.18 170 548772 39282 62900798
Wrong technique in product usage process 52.72 10.18 319 548623 62021 62878059
Restlessness 52.34 10.18 110 548832 29343 62910737
Drug level increased 52.28 10.18 72 548870 22664 62917416
Grip strength decreased 52.20 10.18 351 548591 21936 62918144
Torsade de pointes 52.20 10.18 25 548917 13326 62926754
Blood pressure systolic increased 52.07 10.18 633 548309 46764 62893316
Osteoporosis 51.83 10.18 739 548203 56599 62883481
Stomatitis 51.70 10.18 1568 547374 137157 62802923
Respiratory depression 51.64 10.18 27 548915 13688 62926392
Blood pressure decreased 51.25 10.18 340 548602 64682 62875398
Diabetic ketoacidosis 51.22 10.18 61 548881 20444 62919636
Weight increased 50.79 10.18 2749 546193 258043 62682037
Cerebral haemorrhage 50.33 10.18 120 548822 30609 62909471
Extrapyramidal disorder 50.24 10.18 26 548916 13258 62926822
Insomnia 50.09 10.18 1447 547495 213805 62726275
Disturbance in attention 50.06 10.18 166 548776 38023 62902057
Joint laxity 49.83 10.18 82 548860 2382 62937698
Bone erosion 49.57 10.18 292 548650 17425 62922655
Infection 49.15 10.18 2438 546504 226735 62713345
Metastases to liver 48.43 10.18 81 548861 23558 62916522
Accidental exposure to product 48.16 10.18 103 548839 27302 62912778
Hypothermia 47.88 10.18 29 548913 13552 62926528
Caesarean section 47.84 10.18 281 548661 16751 62923329
Blood calcium decreased 47.67 10.18 98 548844 26353 62913727
Posterior reversible encephalopathy syndrome 47.30 10.18 48 548894 17297 62922783
Joint range of motion decreased 47.16 10.18 458 548484 31970 62908110
Respiratory disorder 47.13 10.18 176 548766 38906 62901174
Mental status changes 46.67 10.18 180 548762 39419 62900661
Pulmonary embolism 46.41 10.18 719 548223 115965 62824115
Joint destruction 46.34 10.18 139 548803 6113 62933967
Hypokalaemia 46.05 10.18 626 548316 103178 62836902
Urticaria 45.30 10.18 1089 547853 164713 62775367
Speech disorder 45.16 10.18 189 548753 40440 62899640
Dysphagia 45.00 10.18 519 548423 88066 62852014
Schizophrenia 44.85 10.18 15 548927 9937 62930143
Unresponsive to stimuli 44.32 10.18 147 548795 33669 62906411
Inappropriate antidiuretic hormone secretion 44.24 10.18 41 548901 15421 62924659
Blood alkaline phosphatase increased 44.05 10.18 206 548736 42761 62897319
Drug tolerance decreased 43.85 10.18 280 548662 17193 62922887
Emotional distress 43.69 10.18 140 548802 32409 62907671
Palpitations 43.46 10.18 699 548243 112071 62828009
Abnormal behaviour 43.36 10.18 74 548868 21352 62918728
Inflammation 43.17 10.18 973 547969 81300 62858780
Chronic kidney disease 42.34 10.18 225 548717 45173 62894907
Ascites 41.91 10.18 195 548747 40533 62899547
C-reactive protein increased 41.84 10.18 1094 547848 93613 62846467
Injection site reaction 41.77 10.18 725 548217 57799 62882281
Muscle spasticity 41.65 10.18 78 548864 21716 62918364
Polyarthritis 41.52 10.18 186 548756 9960 62930120
Loss of personal independence in daily activities 41.31 10.18 1118 547824 96172 62843908
Injection site pruritus 40.98 10.18 582 548360 44534 62895546
Fluid retention 40.81 10.18 325 548617 59361 62880719
Dysarthria 40.77 10.18 210 548732 42501 62897579
Depression 40.31 10.18 1343 547599 195149 62744931
Polyneuropathy 40.21 10.18 40 548902 14549 62925531
Device difficult to use 40.20 10.18 31 548911 12765 62927315
Acute hepatic failure 40.20 10.18 60 548882 18267 62921813
Sepsis 40.12 10.18 1012 547930 152111 62787969
Diabetes mellitus inadequate control 39.96 10.18 43 548899 15083 62924997
Stress cardiomyopathy 39.62 10.18 16 548926 9434 62930646
Withdrawal syndrome 39.61 10.18 70 548872 19927 62920153
Premature labour 39.56 10.18 213 548729 12291 62927789
Blood bilirubin increased 39.31 10.18 176 548766 36964 62903116
Foetal exposure during pregnancy 39.18 10.18 436 548506 31526 62908554
Akathisia 39.15 10.18 15 548927 9131 62930949
Flushing 38.89 10.18 438 548504 74649 62865431
Disease recurrence 38.73 10.18 119 548823 27911 62912169
Accidental overdose 38.19 10.18 91 548851 23218 62916862
Thrombotic microangiopathy 38.01 10.18 22 548920 10539 62929541
White blood cell count decreased 37.90 10.18 914 548028 138190 62801890
Maternal exposure before pregnancy 37.85 10.18 148 548794 7455 62932625
Disability 37.74 10.18 280 548662 18067 62922013
Pain in jaw 37.61 10.18 221 548721 43275 62896805
Gestational diabetes 37.48 10.18 158 548784 8238 62931842
Blood pressure diastolic decreased 37.20 10.18 329 548613 22377 62917703
Eosinophilia 37.16 10.18 89 548853 22667 62917413
Myelosuppression 36.91 10.18 95 548847 23608 62916472
Neck deformity 36.86 10.18 66 548876 2055 62938025
Platelet count decreased 36.49 10.18 746 548196 115376 62824704
Psychotic disorder 36.35 10.18 108 548834 25604 62914476
Product administration error 36.25 10.18 88 548854 22309 62917771
Arrhythmia 36.14 10.18 188 548754 37952 62902128
Haemorrhage 36.08 10.18 345 548597 60677 62879403
Cerebrovascular accident 36.05 10.18 687 548255 107337 62832743
Blood creatinine increased 36.05 10.18 538 548404 87306 62852774
Multiple fractures 36.03 10.18 159 548783 8459 62931621
Hospitalisation 35.98 10.18 518 548424 84563 62855517
Rheumatoid nodule 35.97 10.18 263 548679 16892 62923188
Neurotoxicity 35.95 10.18 57 548885 16933 62923147
Second primary malignancy 35.82 10.18 12 548930 7941 62932139
Ventricular fibrillation 35.72 10.18 30 548912 11837 62928243
Vertigo 35.66 10.18 338 548604 59549 62880531
Neuroleptic malignant syndrome 35.65 10.18 31 548911 12025 62928055
Pulmonary oedema 35.60 10.18 303 548639 54570 62885510
Agranulocytosis 35.23 10.18 106 548836 25028 62915052
Respiratory distress 34.67 10.18 163 548779 33788 62906292
Coagulopathy 34.63 10.18 79 548863 20465 62919615
Parkinsonism 34.47 10.18 24 548918 10415 62929665
Joint stiffness 34.46 10.18 531 548411 41338 62898742
Gastrointestinal haemorrhage 34.41 10.18 494 548448 80682 62859398
Pancreatitis acute 34.30 10.18 120 548822 27046 62913034
Bronchospasm 33.77 10.18 61 548881 17219 62922861
Palmar-plantar erythrodysaesthesia syndrome 33.76 10.18 95 548847 22920 62917160
Toxic skin eruption 33.63 10.18 37 548905 12848 62927232
Atrial fibrillation 33.54 10.18 760 548182 115876 62824204
Acute generalised exanthematous pustulosis 33.48 10.18 28 548914 11071 62929009
Hypomania 33.34 10.18 7 548935 6323 62933757
Melaena 33.29 10.18 142 548800 30223 62909857
Face oedema 33.04 10.18 79 548863 20133 62919947
Maternal drugs affecting foetus 32.86 10.18 110 548832 5132 62934948
Depressed mood 32.77 10.18 208 548734 39983 62900097
Adverse event 32.68 10.18 790 548152 66769 62873311
Nodule 32.58 10.18 301 548641 20725 62919355
Forced expiratory volume decreased 31.97 10.18 3 548939 4965 62935115
Exposure to toxic agent 31.97 10.18 5 548937 5582 62934498
Bone pain 31.85 10.18 310 548632 54331 62885749
Haematotoxicity 31.71 10.18 21 548921 9355 62930725
Transplant rejection 31.54 10.18 28 548914 10752 62929328
Hemiparesis 31.35 10.18 100 548842 23182 62916898
Lupus-like syndrome 31.22 10.18 233 548709 15062 62925018
International normalised ratio increased 31.18 10.18 254 548688 46171 62893909
Device use error 31.11 10.18 6 548936 5755 62934325
Laryngitis 31.05 10.18 252 548690 16715 62923365
Alanine aminotransferase increased 30.74 10.18 673 548269 103097 62836983
Dysgeusia 30.72 10.18 257 548685 46453 62893627
Obstructive airways disorder 30.69 10.18 85 548857 20614 62919466
Neuropathy peripheral 30.64 10.18 748 548194 112919 62827161
Latent tuberculosis 30.38 10.18 69 548873 2558 62937522
Ischaemic stroke 30.31 10.18 69 548873 17888 62922192
Ventricular septal defect 30.27 10.18 95 548847 4283 62935797
Tenderness 30.00 10.18 313 548629 22265 62917815
Atrioventricular block complete 29.96 10.18 17 548925 8234 62931846
Miosis 29.94 10.18 13 548929 7340 62932740
Nightmare 29.83 10.18 77 548865 19117 62920963
Gastrointestinal disorder 29.75 10.18 1404 547538 129835 62810245
Pulmonary arterial hypertension 29.68 10.18 98 548844 22479 62917601
Dyskinesia 29.62 10.18 159 548783 31843 62908237
Cardiogenic shock 29.39 10.18 70 548872 17862 62922218
Tumour lysis syndrome 29.25 10.18 21 548921 8969 62931111
Pleural effusion 29.22 10.18 599 548343 92611 62847469
Decreased appetite 29.22 10.18 1825 547117 249227 62690853
Musculoskeletal pain 29.19 10.18 1023 547919 91254 62848826
Stevens-Johnson syndrome 29.02 10.18 114 548828 24836 62915244
Dyspnoea exertional 28.82 10.18 358 548584 59944 62880136
Hypomagnesaemia 28.74 10.18 139 548803 28598 62911482
Metastases to central nervous system 28.65 10.18 43 548899 13062 62927018
Hepatotoxicity 28.53 10.18 195 548747 36846 62903234
Myoclonus 28.42 10.18 59 548883 15809 62924271
Mobility decreased 28.29 10.18 1300 547642 119859 62820221
Substance abuse 28.20 10.18 4 548938 4803 62935277
Enthesopathy 28.12 10.18 148 548794 8466 62931614
Joint dislocation 28.06 10.18 267 548675 18533 62921547
Panic attack 27.96 10.18 99 548843 22232 62917848
Pain in extremity 27.89 10.18 3274 545668 328212 62611868
Heart rate decreased 27.85 10.18 551 548391 45009 62895071
Pre-eclampsia 27.83 10.18 154 548788 8979 62931101
Injection site swelling 27.64 10.18 571 548371 47001 62893079
Angina pectoris 27.53 10.18 150 548792 29928 62910152
Graft versus host disease 27.47 10.18 12 548930 6751 62933329
Aspartate aminotransferase increased 27.46 10.18 583 548359 89694 62850386
Proteinuria 27.37 10.18 80 548862 19065 62921015
Aphasia 27.31 10.18 170 548772 32830 62907250
Haemophagocytic lymphohistiocytosis 27.20 10.18 31 548911 10596 62929484
Erythema multiforme 26.76 10.18 29 548913 10140 62929940
Asphyxia 26.68 10.18 10 548932 6171 62933909
Haemorrhage intracranial 26.56 10.18 47 548895 13372 62926708
Rash maculo-papular 26.56 10.18 164 548778 31732 62908348
Cytopenia 26.41 10.18 37 548905 11564 62928516
Ankylosing spondylitis 26.38 10.18 168 548774 10306 62929774
Temperature regulation disorder 26.34 10.18 10 548932 6122 62933958
Back pain 26.27 10.18 1947 546995 262198 62677882
Hallucination, auditory 26.22 10.18 44 548898 12780 62927300
Brain oedema 26.08 10.18 52 548890 14143 62925937
Limb deformity 26.00 10.18 85 548857 3917 62936163
Haematoma 25.99 10.18 185 548757 34635 62905445
Wheelchair user 25.98 10.18 116 548826 6203 62933877
Localised infection 25.97 10.18 386 548556 29824 62910256
Bradyphrenia 25.90 10.18 14 548928 6966 62933114
Irritability 25.85 10.18 164 548778 31530 62908550
Metastases to lung 25.83 10.18 44 548898 12706 62927374
Personality disorder 25.77 10.18 9 548933 5802 62934278
Acute myeloid leukaemia 25.73 10.18 70 548872 17077 62923003
Tachypnoea 25.69 10.18 71 548871 17231 62922849
Mania 25.68 10.18 42 548900 12325 62927755
Muscle twitching 25.43 10.18 86 548856 19582 62920498
Chest pain 25.28 10.18 1569 547373 214390 62725690
Acute graft versus host disease 25.25 10.18 4 548938 4424 62935656
Jaundice 25.09 10.18 149 548793 29102 62910978
Dystonia 25.07 10.18 51 548891 13768 62926312
Malaise 25.01 10.18 3182 545760 412772 62527308
Prescribed underdose 25.00 10.18 378 548564 29311 62910769
Blood pressure diastolic increased 24.87 10.18 160 548782 9850 62930230
Peripheral venous disease 24.71 10.18 223 548719 15254 62924826
Premature rupture of membranes 24.70 10.18 97 548845 4896 62935184
Small for dates baby 24.66 10.18 80 548862 3671 62936409
Device related infection 24.66 10.18 111 548831 23281 62916799
Aggression 24.48 10.18 112 548830 23386 62916694
Colitis 24.37 10.18 285 548657 48243 62891837
Hyperlipidaemia 24.34 10.18 87 548855 19484 62920596
Pyrexia 24.29 10.18 3633 545309 466845 62473235
Rhinitis allergic 24.19 10.18 40 548902 11687 62928393
Paralysis 24.15 10.18 30 548912 9870 62930210
Gastroenteritis viral 24.09 10.18 312 548630 23388 62916692
Nasal polyps 24.08 10.18 11 548931 6028 62934052
Febrile bone marrow aplasia 23.98 10.18 17 548925 7308 62932772
Acute respiratory failure 23.93 10.18 187 548755 34298 62905782
Breast cancer stage I 23.88 10.18 15 548927 6874 62933206
Malignant mediastinal neoplasm 23.87 10.18 44 548898 1402 62938678
Labelled drug-drug interaction medication error 23.84 10.18 50 548892 13349 62926731
Cerebral infarction 23.65 10.18 116 548826 23777 62916303
Femur fracture 23.55 10.18 499 548443 41257 62898823
Deep vein thrombosis 23.54 10.18 548 548394 83252 62856828
Diabetes mellitus 23.52 10.18 340 548602 55470 62884610
Bronchopulmonary aspergillosis 23.43 10.18 24 548918 8611 62931469
Smear cervix abnormal 23.27 10.18 67 548875 2879 62937201
Lip swelling 23.20 10.18 165 548777 30898 62909182
Facet joint syndrome 23.15 10.18 182 548760 11956 62928124
General physical health deterioration 23.08 10.18 2032 546910 199370 62740710
Anuria 23.04 10.18 46 548896 12505 62927575
Neck mass 22.93 10.18 76 548866 3527 62936553
Off label use 22.90 10.18 5325 543617 669137 62270943
Obesity 22.81 10.18 375 548567 29577 62910503
Pulmonary hypertension 22.75 10.18 208 548734 36915 62903165
Circulatory collapse 22.59 10.18 105 548837 21833 62918247
Skin papilloma 22.56 10.18 94 548848 4875 62935205
Lymphocyte count decreased 22.46 10.18 161 548781 30096 62909984
Abdominal pain 22.46 10.18 2208 546734 291248 62648832
Rotator cuff repair 22.44 10.18 54 548888 2080 62938000
Tenosynovitis stenosans 22.35 10.18 72 548870 3292 62936788
Delirium 22.33 10.18 305 548637 50236 62889844
Haemoptysis 22.24 10.18 151 548791 28575 62911505
Swollen tongue 22.20 10.18 193 548749 34607 62905473
Tenosynovitis 22.14 10.18 199 548743 13596 62926484
Pathogen resistance 22.08 10.18 14 548928 6384 62933696
Cyanosis 21.93 10.18 74 548868 16861 62923219
Injection site bruising 21.78 10.18 495 548447 41415 62898665
Pulmonary tuberculosis 21.74 10.18 87 548855 4430 62935650
Fear 21.73 10.18 67 548875 15699 62924381
Complication of device insertion 21.71 10.18 20 548922 7544 62932536
Urinary retention 21.65 10.18 163 548779 30138 62909942
Acidosis 21.64 10.18 40 548902 11193 62928887
Sleep apnoea syndrome 21.64 10.18 155 548787 28978 62911102
Exostosis 21.59 10.18 243 548699 17619 62922461
Purpura 21.53 10.18 41 548901 11344 62928736
Myocarditis 21.50 10.18 35 548907 10290 62929790
Genital haemorrhage 21.50 10.18 19 548923 7313 62932767
Red blood cell sedimentation rate 21.40 10.18 91 548851 4763 62935317
Skin exfoliation 21.31 10.18 254 548688 42848 62897232
Hallucination, visual 21.30 10.18 90 548852 19208 62920872
Retinitis 21.29 10.18 108 548834 6088 62933992
Infective pulmonary exacerbation of cystic fibrosis 21.21 10.18 27 548915 8790 62931290
Mental disorder 21.20 10.18 134 548808 25785 62914295
Complication of device removal 21.08 10.18 9 548933 5133 62934947
Arthritis infective 20.94 10.18 111 548831 6367 62933713
Dysmorphism 20.90 10.18 55 548887 2241 62937839
Dislocation of vertebra 20.83 10.18 137 548805 8498 62931582
Schizoaffective disorder 20.81 10.18 3 548939 3559 62936521
Ketoacidosis 20.80 10.18 6 548936 4372 62935708
Synovial cyst 20.77 10.18 158 548784 10275 62929805
Sexual dysfunction 20.66 10.18 6 548936 4353 62935727
Maternal exposure timing unspecified 20.60 10.18 118 548824 6969 62933111
Tardive dyskinesia 20.49 10.18 26 548916 8476 62931604
Developmental hip dysplasia 20.48 10.18 40 548902 1332 62938748
Dry skin 20.47 10.18 357 548585 56530 62883550
Injection site pain 20.45 10.18 1343 547599 128457 62811623
Skin ulcer 20.41 10.18 502 548440 42543 62897537
Pemphigoid 20.39 10.18 20 548922 7324 62932756
Placental disorder 20.25 10.18 42 548900 1462 62938618
Product dose omission issue 20.22 10.18 1747 547195 232566 62707514
Wound infection 20.17 10.18 278 548664 21132 62918948
Cardiotoxicity 20.13 10.18 26 548916 8412 62931668
Tubulointerstitial nephritis 20.06 10.18 96 548846 19807 62920273
Procedural pain 20.05 10.18 107 548835 21462 62918618
Hypothyroidism 20.03 10.18 254 548688 42378 62897702
Pulmonary congestion 20.00 10.18 80 548862 17338 62922742
Anti-cyclic citrullinated peptide antibody 19.96 10.18 113 548829 6645 62933435
Malignant melanoma 19.89 10.18 167 548775 11189 62928891
Synovial fluid analysis 19.87 10.18 56 548886 2377 62937703
Lip dry 19.86 10.18 213 548729 15257 62924823
Lethargy 19.67 10.18 353 548589 55654 62884426
Synovial disorder 19.66 10.18 50 548892 1995 62938085
Acute respiratory distress syndrome 19.59 10.18 121 548821 23413 62916667
Coronary artery disease 19.59 10.18 182 548760 32195 62907885
Body height below normal 19.57 10.18 52 548890 2131 62937949
Cardiomyopathy 19.41 10.18 82 548860 17502 62922578
Injection site rash 19.28 10.18 248 548694 18561 62921519
Sinus bradycardia 19.24 10.18 63 548879 14488 62925592
Hyperprolactinaemia 19.18 10.18 5 548937 3895 62936185
Clostridium difficile colitis 19.14 10.18 102 548840 20467 62919613
Sinus tachycardia 19.07 10.18 127 548815 24141 62915939
Muscle spasms 19.05 10.18 1130 547812 155020 62785060
Eating disorder 19.01 10.18 92 548850 18924 62921156
Hepatitis acute 18.91 10.18 31 548911 9089 62930991
Acute myocardial infarction 18.83 10.18 182 548760 31942 62908138
Paranoia 18.81 10.18 46 548896 11633 62928447
Body temperature decreased 18.80 10.18 263 548679 20056 62920024
Nervousness 18.80 10.18 174 548768 30805 62909275
Therapy partial responder 18.77 10.18 40 548902 10618 62929462
Leukocytosis 18.77 10.18 139 548803 25796 62914284
Anhedonia 18.66 10.18 42 548900 10932 62929148
Loose body in joint 18.60 10.18 37 548905 1249 62938831
Prescribed overdose 18.57 10.18 406 548536 33747 62906333
Atrial septal defect 18.55 10.18 113 548829 6825 62933255
Infusion site pain 18.42 10.18 79 548863 16790 62923290
Hypervolaemia 18.38 10.18 157 548785 28256 62911824
Adjustment disorder with depressed mood 18.37 10.18 151 548791 10053 62930027
Cough 18.37 10.18 2233 546709 290510 62649570
Graft versus host disease in gastrointestinal tract 18.32 10.18 3 548939 3238 62936842
Polyhydramnios 18.28 10.18 52 548890 2219 62937861
Aspergillus infection 18.24 10.18 26 548916 8067 62932013
Colitis microscopic 18.22 10.18 33 548909 9306 62930774
Pseudomonas infection 18.19 10.18 44 548898 11169 62928911
Hepatic cytolysis 18.18 10.18 70 548872 15337 62924743
Hemiplegia 18.14 10.18 33 548909 9290 62930790
Chronic sinusitis 18.12 10.18 54 548888 12789 62927291
Delusion 18.08 10.18 49 548893 11968 62928112
Psychomotor hyperactivity 17.97 10.18 41 548901 10622 62929458
Rash erythematous 17.90 10.18 259 548683 42251 62897829
Klebsiella infection 17.87 10.18 29 548913 8537 62931543
Renal injury 17.84 10.18 34 548908 9405 62930675
Foetal anticonvulsant syndrome 17.79 10.18 24 548918 581 62939499
Hypophosphataemia 17.63 10.18 46 548896 11380 62928700
Spinal stenosis 17.57 10.18 202 548740 14723 62925357
Dermatitis atopic 17.54 10.18 36 548906 9688 62930392
Acute chest syndrome 17.52 10.18 28 548914 793 62939287
Hepatitis B reactivation 17.52 10.18 3 548939 3134 62936946
Status epilepticus 17.47 10.18 70 548872 15163 62924917
Generalised oedema 17.32 10.18 74 548868 15744 62924336
Multiple drug therapy 17.32 10.18 5 548937 3641 62936439
Pericardial effusion 17.32 10.18 171 548771 29887 62910193
Sensitisation 17.32 10.18 4 548938 3382 62936698
Pancreatitis 17.29 10.18 309 548633 48746 62891334
Therapeutic response decreased 17.25 10.18 673 548269 60852 62879228
Fall 17.24 10.18 3057 545885 389277 62550803
Deep vein thrombosis postoperative 17.24 10.18 162 548780 11207 62928873
Hypermethioninaemia 17.20 10.18 9 548933 51 62940029
Headache 17.20 10.18 5049 543893 628192 62311888
Neutropenic colitis 17.20 10.18 3 548939 3092 62936988
Clear cell renal cell carcinoma 17.17 10.18 39 548903 1446 62938634
Product prescribing error 17.12 10.18 145 548797 26144 62913936
Epstein-Barr virus infection 17.04 10.18 27 548915 8023 62932057
Oliguria 17.01 10.18 33 548909 9068 62931012
Rebound effect 16.91 10.18 9 548933 4517 62935563
Eosinophil count increased 16.86 10.18 44 548898 10884 62929196
Rheumatoid lung 16.86 10.18 72 548870 3776 62936304
Memory impairment 16.85 10.18 733 548209 103525 62836555
Polyuria 16.83 10.18 30 548912 8512 62931568
Atrioventricular block 16.81 10.18 25 548917 7622 62932458
Blood glucose decreased 16.79 10.18 109 548833 20843 62919237
Pallor 16.75 10.18 176 548766 30392 62909688
Laryngospasm 16.68 10.18 3 548939 3025 62937055
Sleep disorder due to a general medical condition 16.65 10.18 52 548890 12136 62927944
Bradypnoea 16.62 10.18 5 548937 3545 62936535
Cardiac failure acute 16.56 10.18 36 548906 9487 62930593
Cholecystitis chronic 16.54 10.18 41 548901 10320 62929760
Muscle rigidity 16.48 10.18 48 548894 11452 62928628
Complication associated with device 16.47 10.18 83 548859 16895 62923185
Premature delivery 16.47 10.18 360 548582 29921 62910159
Urinary incontinence 16.47 10.18 187 548755 31827 62908253
Hyperthyroidism 16.46 10.18 68 548874 14605 62925475
Presyncope 16.46 10.18 157 548785 27628 62912452
Immune reconstitution inflammatory syndrome 16.40 10.18 17 548925 6067 62934013
Breast cancer female 16.39 10.18 61 548881 13498 62926582
Transplant dysfunction 16.36 10.18 11 548931 4861 62935219
Hypophagia 16.31 10.18 182 548760 31077 62909003
Subarachnoid haemorrhage 16.15 10.18 66 548876 14217 62925863
Cytomegalovirus viraemia 16.14 10.18 15 548927 5634 62934446
Jaundice cholestatic 16.04 10.18 24 548918 7300 62932780
Blood potassium decreased 16.01 10.18 261 548681 41765 62898315
Systemic inflammatory response syndrome 15.97 10.18 15 548927 5606 62934474
Chills 15.95 10.18 809 548133 112569 62827511
Bone marrow failure 15.90 10.18 169 548773 29121 62910959
Congenital arterial malformation 15.90 10.18 17 548925 320 62939760
Antinuclear antibody positive 15.85 10.18 121 548821 7878 62932202
Aspiration 15.76 10.18 45 548897 10806 62929274
Renal disorder 15.66 10.18 196 548746 32778 62907302
Affective disorder 15.66 10.18 18 548924 6128 62933952
Right ventricular failure 15.57 10.18 86 548856 17102 62922978
Human antichimeric antibody positive 15.54 10.18 41 548901 1673 62938407
Bursitis 15.52 10.18 425 548517 36616 62903464
Glycosylated haemoglobin increased 15.50 10.18 55 548887 12343 62927737
Mucormycosis 15.48 10.18 3 548939 2868 62937212
Antibody test positive 15.40 10.18 55 548887 2652 62937428
Product preparation error 15.35 10.18 18 548924 6074 62934006
Renal tubular necrosis 15.31 10.18 52 548890 11826 62928254
Middle insomnia 15.20 10.18 57 548885 12586 62927494
Pulseless electrical activity 15.20 10.18 26 548916 7495 62932585
Treatment noncompliance 15.17 10.18 229 548713 37096 62902984
Shock haemorrhagic 15.15 10.18 40 548902 9855 62930225
Haematemesis 15.12 10.18 179 548763 30233 62909847
Skin cancer 15.10 10.18 159 548783 11336 62928744
Subdural haematoma 15.10 10.18 68 548874 14260 62925820
Stillbirth 15.03 10.18 105 548837 6645 62933435
Carotid artery thrombosis 14.90 10.18 3 548939 2791 62937289
Multiple allergies 14.85 10.18 65 548877 13737 62926343
Body temperature increased 14.83 10.18 229 548713 36963 62903117
Hallucinations, mixed 14.79 10.18 12 548930 4817 62935263
Erythema 14.77 10.18 1313 547629 174438 62765642
Respiratory acidosis 14.71 10.18 22 548920 6693 62933387
Acute coronary syndrome 14.70 10.18 42 548900 10084 62929996
Crying 14.65 10.18 130 548812 23213 62916867
Food allergy 14.64 10.18 50 548892 11351 62928729
Abdominal distension 14.61 10.18 606 548336 86009 62854071
Hyperuricaemia 14.48 10.18 15 548927 5355 62934725
Electrocardiogram QRS complex prolonged 14.48 10.18 18 548924 5920 62934160
Muscular weakness 14.46 10.18 888 548054 121465 62818615
Fracture delayed union 14.46 10.18 50 548892 2372 62937708
Oropharyngeal pain 14.41 10.18 975 547967 93512 62846568
Scleritis 14.40 10.18 76 548866 4352 62935728
Lymphopenia 14.35 10.18 96 548846 18231 62921849
Oedema peripheral 14.33 10.18 1427 547515 188084 62751996
Ileus 14.28 10.18 72 548870 14653 62925427
Bone lesion 14.16 10.18 18 548924 5863 62934217
Product adhesion issue 14.12 10.18 12 548930 4707 62935373
Skin toxicity 14.09 10.18 12 548930 4702 62935378
Inadequate analgesia 14.05 10.18 4 548938 2939 62937141
Toxic encephalopathy 13.99 10.18 22 548920 6557 62933523
Maternal exposure during breast feeding 13.93 10.18 73 548869 4168 62935912
Dermatitis exfoliative 13.89 10.18 16 548926 5443 62934637
Breast feeding 13.88 10.18 26 548916 839 62939241
Reversible cerebral vasoconstriction syndrome 13.87 10.18 3 548939 2655 62937425
Hypernatraemia 13.87 10.18 28 548914 7581 62932499
Lupus vulgaris 13.80 10.18 94 548848 5900 62934180
Injection site warmth 13.79 10.18 196 548746 14999 62925081
Autism spectrum disorder 13.77 10.18 26 548916 844 62939236
Mucosal inflammation 13.71 10.18 305 548637 46623 62893457
Tinnitus 13.66 10.18 221 548721 35407 62904673
Tendonitis 13.64 10.18 242 548700 19373 62920707
Abortion incomplete 13.63 10.18 5 548937 3126 62936954
Diabetes insipidus 13.63 10.18 3 548939 2622 62937458
Blood parathyroid hormone decreased 13.61 10.18 137 548805 9654 62930426
Pulmonary haemorrhage 13.46 10.18 26 548916 7155 62932925
Glomerular filtration rate decreased 13.45 10.18 65 548877 13376 62926704
Ear infection 13.44 10.18 429 548513 37784 62902296
Product substitution issue 13.44 10.18 82 548860 15914 62924166
Fear of injection 13.43 10.18 107 548835 7057 62933023
Chronic graft versus host disease 13.42 10.18 5 548937 3097 62936983
Cushingoid 13.41 10.18 122 548820 8363 62931717
Progressive multifocal leukoencephalopathy 13.41 10.18 62 548880 12909 62927171
Postoperative wound infection 13.37 10.18 149 548793 10776 62929304
Induced labour 13.33 10.18 27 548915 924 62939156
Salivary hypersecretion 13.31 10.18 29 548913 7637 62932443
Exomphalos 13.29 10.18 20 548922 537 62939543
Device breakage 13.26 10.18 53 548889 11489 62928591
Cyst 13.25 10.18 183 548759 13916 62926164
Hypoglycaemic coma 13.25 10.18 3 548939 2572 62937508
Dysuria 13.03 10.18 209 548733 33529 62906551
Visual impairment 12.97 10.18 597 548345 83849 62856231
Head injury 12.95 10.18 163 548779 27233 62912847
Affect lability 12.94 10.18 51 548891 11100 62928980
Cholestasis of pregnancy 12.88 10.18 31 548911 1194 62938886
Bundle branch block left 12.85 10.18 26 548916 7033 62933047
Gastroschisis 12.78 10.18 17 548925 406 62939674
Granuloma skin 12.68 10.18 120 548822 8317 62931763
Short stature 12.68 10.18 22 548920 668 62939412
Incorrect product administration duration 12.65 10.18 54 548888 11492 62928588
Visual acuity reduced 12.64 10.18 124 548818 21702 62918378
Pulmonary alveolar haemorrhage 12.63 10.18 13 548929 4655 62935425
Wrong product administered 12.62 10.18 21 548921 6120 62933960
Haemorrhage in pregnancy 12.61 10.18 41 548901 1884 62938196
Squamous cell carcinoma 12.59 10.18 122 548820 8510 62931570
Feeling hot 12.59 10.18 335 548607 50019 62890061
Colorectal cancer 12.55 10.18 8 548934 3637 62936443
Abortion missed 12.54 10.18 38 548904 1681 62938399
Crohn's disease 12.50 10.18 79 548863 4834 62935246
Metastases to lymph nodes 12.47 10.18 33 548909 8125 62931955
Acute pulmonary oedema 12.47 10.18 33 548909 8125 62931955
Atrial tachycardia 12.42 10.18 11 548931 4229 62935851
Myocardial ischaemia 12.40 10.18 63 548879 12796 62927284
Blood lactate dehydrogenase increased 12.30 10.18 134 548808 22982 62917098
Paraesthesia oral 12.19 10.18 107 548835 19149 62920931
Sleep terror 12.15 10.18 4 548938 2676 62937404
Pneumonia viral 12.14 10.18 32 548910 7890 62932190
Talipes 12.14 10.18 35 548907 1505 62938575
Device dislocation 12.13 10.18 153 548789 25552 62914528
Hepatic necrosis 12.11 10.18 19 548923 5668 62934412
Blood urea increased 12.08 10.18 158 548784 26221 62913859
Adenovirus infection 12.07 10.18 8 548934 3563 62936517
Rectal haemorrhage 12.05 10.18 327 548615 48703 62891377
Hypercholesterolaemia 12.04 10.18 255 548687 21079 62919001
Polydipsia 12.03 10.18 8 548934 3556 62936524
Lymphoedema 12.02 10.18 56 548886 11636 62928444
Onychomycosis 12.01 10.18 113 548829 7819 62932261
Anti-neutrophil cytoplasmic antibody positive vasculitis 12.01 10.18 5 548937 2894 62937186
Lymph gland infection 12.00 10.18 18 548924 482 62939598
Ejection fraction 11.99 10.18 3 548939 2403 62937677
Gestational hypertension 11.99 10.18 47 548895 2370 62937710
Sciatica 11.99 10.18 385 548557 33939 62906141
Hepatitis cholestatic 11.96 10.18 26 548916 6852 62933228
Contrast media allergy 11.96 10.18 3 548939 2398 62937682
Potentiating drug interaction 11.94 10.18 12 548930 4344 62935736
Troponin increased 11.93 10.18 46 548896 10075 62930005
Abdominal pain upper 11.92 10.18 1583 547359 204861 62735219
Injury 11.92 10.18 760 548182 72487 62867593
Cervical incompetence 11.77 10.18 20 548922 597 62939483
Ulcer 11.64 10.18 302 548640 25805 62914275
Congenital cerebral cyst 11.62 10.18 13 548929 258 62939822
Speech disorder developmental 11.61 10.18 21 548921 659 62939421
Transaminases increased 11.56 10.18 196 548746 31171 62908909
Oligoarthritis 11.54 10.18 19 548923 552 62939528
Mouth ulceration 11.53 10.18 370 548572 32614 62907466
Joint lock 11.52 10.18 45 548897 2266 62937814
Learning disorder 11.50 10.18 21 548921 664 62939416
Catheter site erythema 11.47 10.18 12 548930 4264 62935816
Nasal obstruction 11.46 10.18 37 548905 1694 62938386
Hypertelorism 11.45 10.18 17 548925 451 62939629
Joint noise 11.41 10.18 71 548871 4321 62935759
Epistaxis 11.40 10.18 513 548429 72212 62867868
Respiration abnormal 11.37 10.18 24 548918 6393 62933687
Coordination abnormal 11.37 10.18 71 548871 13702 62926378
Bradykinesia 11.36 10.18 17 548925 5171 62934909
Illness 11.34 10.18 330 548612 48729 62891351
Vitamin B6 increased 11.33 10.18 6 548936 35 62940045
Ankle arthroplasty 11.32 10.18 38 548904 1775 62938305
Nystagmus 11.24 10.18 23 548919 6197 62933883
Nephropathy toxic 11.22 10.18 43 548899 9436 62930644
Product physical issue 11.22 10.18 16 548926 4964 62935116
Hyperthermia 11.19 10.18 41 548901 9115 62930965
Blood iron increased 11.16 10.18 34 548908 1508 62938572
Atrial flutter 11.14 10.18 45 548897 9727 62930353
Bronchial secretion retention 11.14 10.18 5 548937 2768 62937312
Drug screen positive 11.14 10.18 9 548933 3620 62936460
Hypocalcaemia 11.10 10.18 200 548742 31513 62908567
Tongue disorder 11.06 10.18 140 548802 10440 62929640
Haemoglobin decreased 11.04 10.18 1428 547514 144057 62796023
Neonatal respiratory distress syndrome 11.04 10.18 51 548891 2767 62937313
Fracture 11.03 10.18 234 548708 19350 62920730
Amylase increased 11.02 10.18 24 548918 6321 62933759
Cardiac disorder 10.96 10.18 345 548597 50471 62889609
Product residue present 10.86 10.18 11 548931 3968 62936112
Ingrown hair 10.83 10.18 19 548923 582 62939498
Nail injury 10.81 10.18 20 548922 639 62939441
Human anti-human antibody test 10.79 10.18 16 548926 424 62939656
Dactylitis 10.78 10.18 48 548894 2564 62937516
Cyst rupture 10.77 10.18 20 548922 641 62939439
Incoherent 10.77 10.18 14 548928 4516 62935564
Drug effective for unapproved indication 10.76 10.18 8 548934 3356 62936724
Chronic obstructive pulmonary disease 10.70 10.18 438 548504 62248 62877832
Pregnancy with contraceptive device 10.66 10.18 15 548927 4679 62935401
Drug abuser 10.65 10.18 6 548936 2917 62937163
Lymphatic fistula 10.64 10.18 22 548920 764 62939316
Coprolalia 10.56 10.18 5 548937 22 62940058
Infusion site swelling 10.52 10.18 46 548896 9724 62930356
Bone disorder 10.50 10.18 250 548692 21076 62919004
Interstitial lung disease 10.47 10.18 433 548509 61475 62878605
Laryngeal oedema 10.46 10.18 21 548921 5697 62934383
Foot operation 10.45 10.18 102 548840 7129 62932951
Multiple sclerosis 10.43 10.18 148 548794 24224 62915856
Eosinophilic granulomatosis with polyangiitis 10.42 10.18 3 548939 2189 62937891
Eyelid haemangioma 10.40 10.18 4 548938 9 62940071
Brain injury 10.38 10.18 29 548913 7014 62933066
Bundle branch block right 10.35 10.18 17 548925 4981 62935099
Dermatitis acneiform 10.34 10.18 17 548925 4979 62935101
Blood phosphorus decreased 10.34 10.18 14 548928 4439 62935641
Pruritus genital 10.33 10.18 5 548937 2649 62937431
Haemodialysis 10.33 10.18 41 548901 8906 62931174
Impaired gastric emptying 10.32 10.18 50 548892 10282 62929798
Knee operation 10.30 10.18 88 548854 5925 62934155
Upper respiratory tract irritation 10.25 10.18 11 548931 208 62939872
Long QT syndrome 10.23 10.18 8 548934 3271 62936809
Forceps delivery 10.21 10.18 11 548931 209 62939871
Intervertebral disc degeneration 10.20 10.18 192 548750 15540 62924540
Injection site haematoma 10.18 10.18 97 548845 6735 62933345

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 509.58 10.22 836 197520 37402 34721173
Drug abuse 401.82 10.22 46 198310 99050 34659525
Toxicity to various agents 318.35 10.22 402 197954 199960 34558615
Completed suicide 310.92 10.22 86 198270 98082 34660493
Foetal exposure during pregnancy 250.86 10.22 621 197735 37480 34721095
Arthralgia 210.07 10.22 1666 196690 168375 34590200
Psoriatic arthropathy 178.79 10.22 366 197990 19432 34739143
Drug interaction 171.15 10.22 681 197675 225265 34533310
Sickle cell anaemia with crisis 132.31 10.22 138 198218 3915 34754660
Intentional overdose 127.87 10.22 44 198312 43630 34714945
Dysmorphism 120.53 10.22 117 198239 3039 34755536
Joint swelling 119.52 10.22 662 197694 59228 34699347
Musculoskeletal stiffness 104.76 10.22 533 197823 46147 34712428
Psoriasis 98.45 10.22 459 197897 38353 34720222
Acute kidney injury 97.18 10.22 1186 197170 303802 34454773
Product use in unapproved indication 92.72 10.22 348 198008 117151 34641424
Premature baby 84.06 10.22 274 198082 19359 34739216
Enthesopathy 75.56 10.22 111 198245 4502 34754073
Rhabdomyolysis 74.70 10.22 173 198183 67990 34690585
Overdose 73.58 10.22 267 198089 90792 34667783
Blood pressure fluctuation 72.61 10.22 310 198046 24939 34733636
Febrile neutropenia 72.30 10.22 467 197889 136382 34622193
Tenosynovitis 72.03 10.22 108 198248 4462 34754113
Coma 71.97 10.22 92 198264 45586 34712989
Drug reaction with eosinophilia and systemic symptoms 71.33 10.22 50 198306 32962 34725613
Synovitis 71.09 10.22 208 198148 13858 34744717
Exposure during pregnancy 67.84 10.22 154 198202 8780 34749795
Suicide attempt 67.83 10.22 73 198283 39043 34719532
Death 66.99 10.22 1734 196622 396315 34362260
Speech disorder developmental 66.66 10.22 72 198284 2128 34756447
Appendicolith 66.13 10.22 149 198207 8452 34750123
Pain 66.02 10.22 1573 196783 203102 34555473
Serotonin syndrome 62.05 10.22 18 198338 19915 34738660
Drug dependence 61.79 10.22 30 198326 24187 34734388
C-reactive protein abnormal 61.59 10.22 146 198210 8564 34750011
Arthropathy 61.59 10.22 309 198047 26598 34731977
Hepatic function abnormal 60.40 10.22 99 198257 44264 34714311
Neonatal respiratory distress syndrome 60.28 10.22 93 198263 3941 34754634
Foetal anticonvulsant syndrome 56.97 10.22 50 198306 1137 34757438
Hypospadias 56.78 10.22 80 198276 3121 34755454
Blood pressure systolic increased 56.41 10.22 269 198087 22683 34735892
Maternal exposure during pregnancy 54.28 10.22 99 198257 4819 34753756
Atrial septal defect 53.46 10.22 125 198231 7267 34751308
Alanine aminotransferase abnormal 52.54 10.22 95 198261 4593 34753982
Tuberculosis 52.45 10.22 136 198220 8441 34750134
Nasopharyngitis 51.29 10.22 615 197741 69353 34689222
Cryptorchism 50.29 10.22 60 198296 1981 34756594
Arthritis 48.83 10.22 325 198031 31021 34727554
Bradycardia 48.08 10.22 242 198114 75176 34683399
Cardiac failure 47.33 10.22 313 198043 90935 34667640
Low birth weight baby 46.96 10.22 124 198232 7781 34750794
Disease progression 46.86 10.22 390 197966 107687 34650888
Angioedema 46.71 10.22 88 198268 37286 34721289
Maternal drugs affecting foetus 46.56 10.22 82 198274 3883 34754692
Learning disorder 46.54 10.22 43 198313 1048 34757527
Peripheral swelling 46.51 10.22 650 197706 75891 34682684
Autism spectrum disorder 46.20 10.22 61 198295 2235 34756340
Appendicitis 45.07 10.22 185 198171 14622 34743953
Respiratory arrest 44.67 10.22 56 198300 27987 34730588
Hypoglycaemia neonatal 43.77 10.22 54 198302 1847 34756728
Small for dates baby 43.28 10.22 79 198277 3848 34754727
Delirium 43.25 10.22 118 198238 43873 34714702
Renal failure 42.06 10.22 506 197850 130051 34628524
Maternal exposure during breast feeding 40.79 10.22 47 198309 1494 34757081
Cytomegalovirus infection 40.79 10.22 53 198303 26082 34732493
Haemoglobin decreased 40.33 10.22 933 197423 119839 34638736
Toxic epidermal necrolysis 40.26 10.22 38 198318 21608 34736967
Syndactyly 40.18 10.22 36 198320 842 34757733
Drug resistance 40.03 10.22 53 198303 25874 34732701
Poisoning 40.01 10.22 10 198346 12216 34746359
Rheumatoid nodule 39.98 10.22 65 198291 2882 34755693
Ventricular septal defect 39.75 10.22 77 198279 3924 34754651
Blood pressure systolic abnormal 39.25 10.22 76 198280 3872 34754703
Tongue disorder 38.30 10.22 90 198266 5249 34753326
Developmental delay 37.36 10.22 61 198295 2714 34755861
Blood pressure diastolic abnormal 36.52 10.22 83 198273 4735 34753840
Altered state of consciousness 36.17 10.22 46 198310 22847 34735728
Cardiac arrest 36.02 10.22 360 197996 95799 34662776
Suicidal ideation 35.60 10.22 114 198242 40274 34718301
Intentional product misuse 35.34 10.22 136 198220 45475 34713100
Renal impairment 35.33 10.22 354 198002 94159 34664416
Pain in extremity 35.02 10.22 953 197403 125560 34633015
Blood pressure diastolic decreased 34.59 10.22 122 198234 8972 34749603
Jaundice neonatal 33.87 10.22 40 198316 1306 34757269
Basal cell carcinoma 33.80 10.22 209 198147 19449 34739126
Hand deformity 33.78 10.22 69 198287 3656 34754919
Joint effusion 33.47 10.22 84 198272 5109 34753466
Osteoarthritis 33.35 10.22 216 198140 20426 34738149
Drug withdrawal syndrome 33.30 10.22 38 198318 19796 34738779
Neuroleptic malignant syndrome 32.75 10.22 32 198324 17902 34740673
Drug intolerance 32.67 10.22 497 197859 59073 34699502
Pathogen resistance 32.53 10.22 7 198349 9475 34749100
Exposure via breast milk 32.39 10.22 48 198308 1962 34756613
Depressed level of consciousness 32.39 10.22 129 198227 42712 34715863
Agitation 32.28 10.22 192 198164 57207 34701368
Foot deformity 32.02 10.22 76 198280 4461 34754114
Joint laxity 31.92 10.22 23 198333 389 34758186
Sedation 31.36 10.22 44 198312 20962 34737613
Heart rate decreased 31.18 10.22 296 198060 31449 34727126
Talipes 31.10 10.22 46 198310 1877 34756698
Shock 31.04 10.22 56 198300 24123 34734452
Pulmonary fibrosis 30.64 10.22 194 198162 18202 34740373
Grip strength decreased 30.29 10.22 60 198296 3109 34755466
Weight decreased 29.67 10.22 1253 197103 175048 34583527
Tendonitis 29.25 10.22 116 198240 9024 34749551
Lower respiratory tract infection 29.12 10.22 291 198065 31346 34727229
Rash maculo-papular 28.96 10.22 75 198281 28376 34730199
Finger deformity 28.62 10.22 39 198317 1474 34757101
Hypoglycaemia 28.53 10.22 187 198169 54453 34704122
Hyperglycaemia 28.52 10.22 121 198235 39359 34719216
Congenital hand malformation 28.43 10.22 25 198331 570 34758005
Pancytopenia 28.40 10.22 724 197632 94433 34664142
Abdominal distension 28.32 10.22 478 197878 58014 34700561
Blood pressure increased 28.28 10.22 677 197679 87425 34671150
Plagiocephaly 28.16 10.22 24 198332 524 34758051
Off label use 28.13 10.22 2026 196330 417498 34341077
Infusion related reaction 28.07 10.22 440 197916 52617 34705958
Knee arthroplasty 27.57 10.22 99 198257 7345 34751230
Substance abuse 27.56 10.22 5 198351 7636 34750939
Musculoskeletal pain 27.51 10.22 290 198066 31673 34726902
Hypermobility syndrome 27.43 10.22 20 198336 345 34758230
Respiratory depression 27.41 10.22 31 198325 16214 34742361
Palmar-plantar erythrodysaesthesia syndrome 27.31 10.22 33 198323 16762 34741813
Malignant neoplasm progression 26.92 10.22 345 198011 87701 34670874
Stress 26.90 10.22 277 198079 30070 34728505
C-reactive protein increased 26.89 10.22 444 197912 53654 34704921
Red blood cell sedimentation rate increased 26.73 10.22 113 198243 9049 34749526
Astigmatism 26.62 10.22 32 198324 1065 34757510
Dysgraphia 26.47 10.22 47 198309 2240 34756335
Blood creatine phosphokinase increased 26.31 10.22 148 198208 44709 34713866
Cleft lip and palate 26.16 10.22 29 198327 883 34757692
Intellectual disability 26.08 10.22 35 198321 1303 34757272
Acute hepatic failure 25.83 10.22 25 198331 14049 34744526
Caesarean section 25.73 10.22 45 198311 2119 34756456
Language disorder 25.64 10.22 46 198310 2210 34756365
Abdominal pain 25.55 10.22 1154 197202 162464 34596111
Venoocclusive liver disease 25.15 10.22 7 198349 7959 34750616
Acute chest syndrome 24.94 10.22 27 198329 800 34757775
Foetal growth restriction 24.88 10.22 65 198291 4052 34754523
Fatigue 24.88 10.22 2433 195923 368220 34390355
Hepatic failure 24.84 10.22 106 198250 34425 34724150
Polyarthritis 24.75 10.22 69 198287 4471 34754104
Diaphragmatic disorder 24.32 10.22 33 198323 1242 34757333
Large for dates baby 24.30 10.22 28 198328 890 34757685
Lactic acidosis 24.24 10.22 108 198248 34664 34723911
Body temperature decreased 23.95 10.22 141 198215 12893 34745682
Anal fistula 23.69 10.22 76 198280 5323 34753252
Anticonvulsant drug level above therapeutic 23.67 10.22 24 198332 658 34757917
Intentional self-injury 23.54 10.22 26 198330 13745 34744830
Tachycardia 23.10 10.22 340 198016 84432 34674143
Hypotonia neonatal 22.95 10.22 33 198323 1312 34757263
Motor developmental delay 22.26 10.22 23 198333 645 34757930
Hydrops foetalis 22.21 10.22 26 198330 841 34757734
Wrong technique in product usage process 22.06 10.22 117 198239 35869 34722706
Ultrasound antenatal screen 21.96 10.22 21 198335 535 34758040
Inflammation 21.73 10.22 251 198105 28044 34730531
Wound 21.30 10.22 151 198205 14713 34743862
Otitis media 21.24 10.22 49 198307 2823 34755752
Selective eating disorder 21.17 10.22 37 198319 1741 34756834
Respiratory failure 21.17 10.22 462 197894 108110 34650465
Ankylosing spondylitis 21.16 10.22 75 198281 5529 34753046
Hypertelorism 21.15 10.22 21 198335 561 34758014
Scoliosis 21.04 10.22 48 198308 2745 34755830
Low set ears 21.01 10.22 19 198337 450 34758125
Hyperbilirubinaemia neonatal 20.95 10.22 24 198332 758 34757817
Colitis ulcerative 20.93 10.22 163 198193 16357 34742218
Neck pain 20.89 10.22 228 198128 25121 34733454
Akathisia 20.75 10.22 10 198346 8099 34750476
Knee deformity 20.48 10.22 22 198334 646 34757929
Ear infection 20.32 10.22 113 198243 10118 34748457
General physical health deterioration 20.30 10.22 906 197450 127363 34631212
Dyspraxia 20.16 10.22 18 198338 419 34758156
Pulmonary tuberculosis 20.03 10.22 66 198290 4688 34753887
Stevens-Johnson syndrome 19.85 10.22 48 198308 18591 34739984
Agranulocytosis 19.78 10.22 69 198287 23752 34734823
Latent tuberculosis 19.77 10.22 31 198325 1332 34757243
Drug withdrawal syndrome neonatal 19.72 10.22 55 198301 3564 34755011
Radiation inflammation 19.71 10.22 25 198331 880 34757695
Vitamin D deficiency 19.67 10.22 82 198274 6526 34752049
Blood pressure diastolic increased 19.62 10.22 68 198288 4957 34753618
Cerebral haemorrhage 19.56 10.22 117 198239 34820 34723755
Trisomy 18 19.55 10.22 23 198333 748 34757827
Drug ineffective for unapproved indication 19.49 10.22 69 198287 23646 34734929
Ventricular tachycardia 19.48 10.22 81 198275 26498 34732077
Skin cancer 19.31 10.22 112 198244 10185 34748390
Nasal disorder 19.03 10.22 37 198319 1891 34756684
Psychotic disorder 18.88 10.22 73 198283 24379 34734196
Neurotoxicity 18.70 10.22 47 198309 17963 34740612
Anaphylactic shock 18.65 10.22 39 198317 15902 34742673
Ear disorder 18.62 10.22 34 198322 1656 34756919
Back disorder 18.61 10.22 81 198275 6570 34752005
Aggression 18.54 10.22 137 198219 38827 34719748
Neck mass 18.48 10.22 33 198323 1580 34756995
Joint stiffness 18.32 10.22 115 198241 10758 34747817
Foetal disorder 18.27 10.22 23 198333 803 34757772
Disseminated intravascular coagulation 18.25 10.22 63 198293 21753 34736822
Excessive eye blinking 18.18 10.22 19 198337 540 34758035
Hydrocele 18.15 10.22 38 198318 2049 34756526
Haematocrit decreased 18.13 10.22 270 198086 31946 34726629
Congenital foot malformation 18.04 10.22 17 198339 425 34758150
Hypotension 17.93 10.22 1052 197304 220597 34537978
Dyslexia 17.93 10.22 15 198341 319 34758256
Blood phosphorus increased 17.90 10.22 89 198267 7632 34750943
Cleft lip 17.81 10.22 15 198341 322 34758253
Upper respiratory tract infection 17.80 10.22 275 198081 32784 34725791
Somnolence 17.79 10.22 487 197869 110629 34647946
Toxic optic neuropathy 17.75 10.22 23 198333 827 34757748
Arthritis infective 17.70 10.22 51 198305 3368 34755207
Hepatic enzyme increased 17.70 10.22 316 198040 38764 34719811
Sleep disorder due to a general medical condition 17.62 10.22 4 198352 5217 34753358
Crohn's disease 17.61 10.22 48 198308 3069 34755506
Limb reduction defect 17.58 10.22 14 198342 277 34758298
Post procedural infection 17.49 10.22 64 198292 4792 34753783
Cholestasis 17.43 10.22 86 198270 26862 34731713
Suspected suicide 17.36 10.22 3 198353 4745 34753830
Gastrointestinal infection 17.29 10.22 72 198284 5726 34752849
Anal atresia 17.28 10.22 14 198342 284 34758291
Red blood cell sedimentation rate 17.21 10.22 27 198329 1161 34757414
Oropharyngeal pain 17.17 10.22 290 198066 35195 34723380
Spinal disorder 17.00 10.22 58 198298 4194 34754381
Aspergillus infection 17.00 10.22 27 198329 12227 34746348
Respiratory disorder neonatal 16.97 10.22 32 198324 1598 34756977
Second primary malignancy 16.96 10.22 12 198344 7874 34750701
Osteonecrosis of jaw 16.83 10.22 49 198307 17840 34740735
Strabismus 16.82 10.22 33 198323 1698 34756877
Localised infection 16.78 10.22 163 198193 17424 34741151
Immune reconstitution inflammatory syndrome 16.74 10.22 15 198341 8744 34749831
Cardio-respiratory arrest 16.73 10.22 217 198139 55056 34703519
Acute graft versus host disease 16.67 10.22 8 198348 6495 34752080
Influenza 16.65 10.22 384 197972 49282 34709293
Blood parathyroid hormone decreased 16.60 10.22 30 198326 1450 34757125
Serum ferritin increased 16.55 10.22 74 198282 6072 34752503
Arthritis bacterial 16.50 10.22 65 198291 5041 34753534
Pyrexia 16.44 10.22 1647 196709 331366 34427209
Medical device implantation 16.41 10.22 19 198337 607 34757968
Umbilical hernia 16.31 10.22 61 198295 4616 34753959
Multiple congenital abnormalities 16.29 10.22 18 198338 546 34758029
Therapeutic product effect decreased 16.11 10.22 282 198074 34461 34724114
Attention deficit hyperactivity disorder 16.08 10.22 41 198315 2518 34756057
Melaena 16.08 10.22 126 198230 35254 34723321
Joint range of motion decreased 16.05 10.22 83 198273 7229 34751346
Electrocardiogram QRS complex prolonged 16.02 10.22 4 198352 4890 34753685
Agitation neonatal 16.00 10.22 25 198331 1071 34757504
Maternal exposure before pregnancy 15.89 10.22 21 198335 770 34757805
Juvenile idiopathic arthritis 15.87 10.22 34 198322 1863 34756712
Withdrawal syndrome 15.85 10.22 29 198327 12426 34746149
Anal fissure 15.84 10.22 57 198299 4233 34754342
Malignant melanoma 15.83 10.22 89 198267 8001 34750574
Lacrimal disorder 15.82 10.22 14 198342 322 34758253
Congenital bladder anomaly 15.79 10.22 13 198343 270 34758305
Sexual dysfunction 15.79 10.22 8 198348 6295 34752280
Drug level increased 15.78 10.22 68 198288 22028 34736547
Granuloma skin 15.73 10.22 27 198329 1252 34757323
Weight decrease neonatal 15.71 10.22 14 198342 325 34758250
Pectus excavatum 15.39 10.22 12 198344 230 34758345
Congenital anomaly 15.32 10.22 28 198328 1365 34757210
Accessory spleen 15.31 10.22 10 198346 143 34758432
Bradycardia neonatal 15.29 10.22 23 198333 953 34757622
Vitamin B12 deficiency 15.26 10.22 54 198302 3977 34754598
Ankyloglossia congenital 15.25 10.22 13 198343 284 34758291
Poor venous access 15.18 10.22 64 198292 5119 34753456
Acute generalised exanthematous pustulosis 14.98 10.22 10 198346 6766 34751809
Renal aplasia 14.87 10.22 20 198336 746 34757829
Sinusitis 14.78 10.22 323 198033 41079 34717496
Immunodeficiency 14.66 10.22 66 198290 5432 34753143
Hyperammonaemia 14.62 10.22 9 198347 6358 34752217
Cystitis haemorrhagic 14.54 10.22 7 198349 5672 34752903
Acute respiratory distress syndrome 14.52 10.22 87 198269 25882 34732693
Back pain 14.48 10.22 837 197519 120952 34637623
Respiratory rate increased 14.46 10.22 101 198255 9793 34748782
Hypertriglyceridaemia 14.38 10.22 16 198340 8432 34750143
Cellulitis 14.38 10.22 398 197958 52553 34706022
Hepatic cyst 14.37 10.22 40 198316 2589 34755986
No adverse event 14.35 10.22 74 198282 22853 34735722
Infection 14.34 10.22 642 197714 90273 34668302
Hepatocellular injury 14.30 10.22 71 198285 22140 34736435
Thrombotic microangiopathy 14.20 10.22 24 198332 10606 34747969
Red blood cell count decreased 14.17 10.22 238 198118 28852 34729723
Synovial cyst 14.16 10.22 37 198319 2307 34756268
Skin injury 14.15 10.22 37 198319 2308 34756267
Lung neoplasm malignant 14.12 10.22 156 198200 17239 34741336
Joint ankylosis 14.11 10.22 29 198327 1543 34757032
Urticaria 14.08 10.22 259 198097 62118 34696457
Haemangioma congenital 14.05 10.22 16 198340 502 34758073
Hyperthermia 14.02 10.22 24 198332 10553 34748022
Microcephaly 13.99 10.22 20 198336 791 34757784
Foetal heart rate deceleration abnormality 13.98 10.22 16 198340 505 34758070
Interstitial lung disease 13.83 10.22 274 198082 65008 34693567
Arthrodesis 13.79 10.22 15 198341 447 34758128
Abortion spontaneous 13.74 10.22 14 198342 386 34758189
Posterior reversible encephalopathy syndrome 13.74 10.22 22 198334 9932 34748643
Vitamin B complex deficiency 13.68 10.22 14 198342 388 34758187
Patent ductus arteriosus 13.63 10.22 46 198310 3308 34755267
Loss of consciousness 13.57 10.22 361 197995 82306 34676269
Eosinophilia 13.55 10.22 90 198266 26132 34732443
C-reactive protein decreased 13.55 10.22 33 198323 1969 34756606
Gaze palsy 13.54 10.22 30 198326 1682 34756893
Oesophageal fibrosis 13.54 10.22 10 198346 176 34758399
Loss of personal independence in daily activities 13.54 10.22 264 198092 32915 34725660
Therapy partial responder 13.52 10.22 21 198335 9595 34748980
Chronic graft versus host disease 13.51 10.22 4 198352 4369 34754206
Hernia pain 13.38 10.22 12 198344 281 34758294
Tooth malformation 13.31 10.22 10 198346 181 34758394
Arnold-Chiari malformation 13.29 10.22 13 198343 341 34758234
Nephrolithiasis 13.28 10.22 244 198112 30089 34728486
Hepatitis E virus test positive 13.17 10.22 12 198344 287 34758288
Mania 13.15 10.22 21 198335 9490 34749085
Anti-cyclic citrullinated peptide antibody positive 13.15 10.22 31 198325 1812 34756763
Behaviour disorder 13.13 10.22 59 198297 4851 34753724
Transplant rejection 13.12 10.22 24 198332 10287 34748288
Progressive multifocal leukoencephalopathy 13.09 10.22 22 198334 9742 34748833
Product quality issue 13.06 10.22 51 198305 16984 34741591
Blood albumin decreased 13.05 10.22 126 198230 13446 34745129
Pulmonary alveolar haemorrhage 13.04 10.22 14 198342 7498 34751077
Diverticular perforation 13 10.22 46 198310 3388 34755187
Cardiotoxicity 12.95 10.22 8 198348 5640 34752935
Fistula discharge 12.90 10.22 20 198336 851 34757724
Polyomavirus-associated nephropathy 12.86 10.22 3 198353 3841 34754734
Developmental coordination disorder 12.85 10.22 10 198346 191 34758384
Microphthalmos 12.85 10.22 10 198346 191 34758384
Pancreatic calcification 12.76 10.22 10 198346 193 34758382
Asphyxia 12.71 10.22 12 198344 6823 34751752
Autoscopy 12.69 10.22 11 198345 246 34758329
Adenovirus infection 12.68 10.22 7 198349 5250 34753325
Nodule 12.68 10.22 74 198282 6745 34751830
Metabolic acidosis 12.67 10.22 173 198183 43507 34715068
Bone cyst 12.62 10.22 28 198328 1572 34757003
Abdominal discomfort 12.59 10.22 436 197920 59399 34699176
Obsessive-compulsive disorder 12.59 10.22 8 198348 5556 34753019
Panniculitis 12.58 10.22 32 198324 1962 34756613
Haemangioma 12.56 10.22 31 198325 1866 34756709
Blood test abnormal 12.54 10.22 75 198281 6896 34751679
Tumour lysis syndrome 12.49 10.22 52 198304 17007 34741568
Bronchopulmonary aspergillosis 12.48 10.22 42 198314 14617 34743958
Acute graft versus host disease in skin 12.44 10.22 7 198349 5194 34753381
Septic arthritis staphylococcal 12.44 10.22 15 198341 501 34758074
Maternal exposure timing unspecified 12.43 10.22 13 198343 370 34758205
Bronchiolitis 12.42 10.22 43 198313 3133 34755442
Kidney infection 12.38 10.22 62 198294 5332 34753243
Cerebral infarction 12.37 10.22 98 198258 27357 34731218
Hepatitis E antibody positive 12.32 10.22 11 198345 256 34758319
Exposure to toxic agent 12.04 10.22 3 198353 3672 34754903
BK virus infection 11.99 10.22 9 198347 5729 34752846
Neutropenia 11.97 10.22 748 197608 156030 34602545
Foetal distress syndrome 11.96 10.22 22 198334 1078 34757497
Fistula 11.93 10.22 73 198283 6767 34751808
Pharyngeal disorder 11.87 10.22 18 198338 751 34757824
Injection site pain 11.69 10.22 297 198059 38708 34719867
Polydactyly 11.63 10.22 23 198333 1190 34757385
Cytomegalovirus chorioretinitis 11.62 10.22 3 198353 3586 34754989
Glycosylated haemoglobin increased 11.52 10.22 30 198326 11330 34747245
Dystonia 11.49 10.22 28 198328 10817 34747758
Pulmonary pain 11.49 10.22 23 198333 1201 34757374
Vascular insufficiency 11.46 10.22 12 198344 342 34758233
Educational problem 11.42 10.22 15 198341 547 34758028
Cholelithiasis 11.42 10.22 176 198180 20972 34737603
Abdominal adhesions 11.40 10.22 26 198330 1487 34757088
Pleuritic pain 11.38 10.22 45 198311 3496 34755079
Blood insulin increased 11.29 10.22 12 198344 348 34758227
Proteinuria 11.21 10.22 61 198295 18581 34739994
Nephrotic syndrome 11.20 10.22 15 198341 7288 34751287
Iron deficiency 11.07 10.22 60 198296 5321 34753254
Haematochezia 11.06 10.22 344 198012 46190 34712385
Spina bifida 11.05 10.22 12 198344 357 34758218
Drug use disorder 10.99 10.22 5 198351 4186 34754389
Hepatitis fulminant 10.98 10.22 5 198351 4185 34754390
Asthma 10.96 10.22 173 198183 42483 34716092
Hallucination 10.95 10.22 216 198140 51282 34707293
Headache 10.89 10.22 1299 197057 199336 34559239
Hypermetropia 10.88 10.22 14 198342 500 34758075
Ear malformation 10.84 10.22 11 198345 302 34758273
Nerve compression 10.80 10.22 42 198314 3237 34755338
Nail pitting 10.78 10.22 11 198345 304 34758271
Nephropathy toxic 10.77 10.22 36 198320 12552 34746023
Gangrene neonatal 10.73 10.22 9 198347 192 34758383
Heart rate irregular 10.73 10.22 137 198219 15670 34742905
Pleural fibrosis 10.71 10.22 24 198332 1356 34757219
Palindromic rheumatism 10.69 10.22 9 198347 193 34758382
Nail bed bleeding 10.68 10.22 12 198344 371 34758204
Cytomegalovirus viraemia 10.66 10.22 16 198340 7414 34751161
Respiratory tract infection viral 10.66 10.22 35 198321 2482 34756093
Device leakage 10.60 10.22 13 198343 6562 34752013
Erectile dysfunction 10.58 10.22 71 198285 20566 34738009
Necrotising fasciitis streptococcal 10.50 10.22 8 198348 148 34758427
Blood homocysteine increased 10.48 10.22 10 198346 254 34758321
Hypermethioninaemia 10.47 10.22 3 198353 3 34758572
Rheumatoid lung 10.44 10.22 19 198337 923 34757652
Injection site rash 10.44 10.22 49 198307 4104 34754471
Fine motor skill dysfunction 10.43 10.22 28 198328 1774 34756801
Pneumonia aspiration 10.41 10.22 171 198185 41732 34716843
Weight increased 10.41 10.22 636 197720 92397 34666178
Unresponsive to stimuli 10.40 10.22 103 198253 27466 34731109
Facial pain 10.38 10.22 4 198352 3700 34754875
Joint instability 10.35 10.22 13 198343 453 34758122
Peritoneal dialysis complication 10.35 10.22 27 198329 1682 34756893
Red blood cell sedimentation rate abnormal 10.26 10.22 44 198312 3545 34755030
Hypertransaminasaemia 10.24 10.22 10 198346 5596 34752979
Pancreatitis 10.24 10.22 157 198199 38734 34719841
Dermatitis acneiform 10.23 10.22 12 198344 6177 34752398

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 1243.74 9.97 149 570341 245618 78928280
Rheumatoid arthritis 1140.30 9.97 3681 566809 204789 78969109
Toxicity to various agents 1038.66 9.97 894 569596 420646 78753252
Arthropathy 901.77 9.97 3053 567437 174058 78999840
Systemic lupus erythematosus 882.80 9.97 2370 568120 118779 79055119
Pemphigus 877.80 9.97 2094 568396 97488 79076410
Hand deformity 850.83 9.97 2124 568366 101795 79072103
Joint swelling 845.15 9.97 4192 566298 284454 78889444
Synovitis 813.21 9.97 2650 567840 148084 79025814
Drug abuse 807.29 9.97 105 570385 162586 79011312
Glossodynia 770.42 9.97 2039 568451 101298 79072600
Arthralgia 682.66 9.97 6660 563830 565143 78608755
Anti-cyclic citrullinated peptide antibody positive 651.91 9.97 1672 568818 81471 79092427
Wound 637.71 9.97 2055 568435 114124 79059774
Maternal exposure during pregnancy 629.25 9.97 2278 568212 134260 79039638
Pericarditis 582.27 9.97 1855 568635 102381 79071517
Infusion related reaction 567.79 9.97 3190 567300 227047 78946851
Abdominal discomfort 551.12 9.97 3370 567120 247357 78926541
Drug interaction 518.60 9.97 1401 569089 413782 78760116
Pain 501.98 9.97 7432 563058 696370 78477528
Swelling 501.82 9.97 2953 567537 213758 78960140
Discomfort 479.04 9.97 1974 568516 123643 79050255
Alopecia 473.67 9.97 3054 567436 228301 78945597
Therapeutic product effect decreased 463.44 9.97 2358 568132 161505 79012393
Intentional overdose 447.83 9.97 104 570386 105856 79068042
Musculoskeletal stiffness 419.48 9.97 2407 568083 172601 79001297
Duodenal ulcer perforation 409.34 9.97 1221 569269 64990 79108908
Helicobacter infection 406.19 9.97 1259 569231 68445 79105453
Contraindicated product administered 396.89 9.97 2196 568294 155342 79018556
Rheumatoid factor positive 389.53 9.97 1124 569366 58715 79115183
Death 382.66 9.97 2429 568061 564085 78609813
Nasopharyngitis 372.90 9.97 3096 567394 250785 78923113
Hepatic enzyme increased 361.05 9.97 2390 568100 180220 78993678
Drug intolerance 358.57 9.97 3165 567325 260954 78912944
Psoriatic arthropathy 357.97 9.97 1300 569190 76699 79097199
Acute kidney injury 338.45 9.97 2251 568239 517153 78656745
Febrile neutropenia 328.51 9.97 728 569762 230271 78943627
Exposure during pregnancy 319.18 9.97 1502 568988 99630 79074268
Cardiac arrest 273.04 9.97 509 569981 171587 79002311
Overdose 268.08 9.97 573 569917 183633 78990265
Impaired healing 266.53 9.97 1288 569202 86367 79087531
Depressed level of consciousness 247.31 9.97 197 570293 96455 79077443
Peripheral swelling 238.32 9.97 2962 567528 266655 78907243
Suicide attempt 234.47 9.97 152 570338 82780 79091118
Hypersensitivity 229.65 9.97 2876 567614 259363 78914535
C-reactive protein abnormal 226.00 9.97 811 569679 47556 79126342
Muscle injury 225.84 9.97 813 569677 47748 79126150
Sinusitis 221.40 9.97 2255 568235 193246 78980652
Folliculitis 219.46 9.97 881 569609 54499 79119399
Irritable bowel syndrome 216.14 9.97 951 569539 61290 79112608
Treatment failure 215.84 9.97 2013 568477 168473 79005425
Rhabdomyolysis 209.97 9.97 257 570233 102874 79071024
Lower respiratory tract infection 209.76 9.97 1613 568877 127607 79046291
Bradycardia 204.50 9.97 413 570077 135144 79038754
Blister 202.14 9.97 1506 568984 117970 79055928
Sickle cell anaemia with crisis 200.45 9.97 265 570225 7657 79166241
Red blood cell sedimentation rate abnormal 198.93 9.97 454 570036 20509 79153389
Arthritis 197.16 9.97 1453 569037 113427 79060471
Sleep disorder due to general medical condition, insomnia type 195.61 9.97 721 569769 42835 79131063
Knee arthroplasty 192.63 9.97 714 569776 42534 79131364
Drug reaction with eosinophilia and systemic symptoms 188.17 9.97 113 570377 64131 79109767
Respiratory arrest 188.02 9.97 88 570402 57462 79116436
Product use issue 183.97 9.97 2302 568188 207520 78966378
Sedation 182.89 9.97 71 570419 51824 79122074
Osteoarthritis 181.10 9.97 1157 569333 86152 79087746
Hip arthroplasty 177.78 9.97 612 569878 35144 79138754
Sopor 171.86 9.97 18 570472 32992 79140906
Blood pressure fluctuation 170.27 9.97 938 569552 66207 79107691
Weight increased 168.22 9.97 2854 567636 274532 78899366
Cardiac failure 168.06 9.97 557 569933 154285 79019613
Renal failure 163.88 9.97 809 569681 200159 78973739
Malignant neoplasm progression 161.89 9.97 469 570021 135521 79038377
Lactic acidosis 155.54 9.97 164 570326 70195 79103703
Disease progression 155.05 9.97 734 569756 183628 78990270
Coma 154.06 9.97 304 570186 100345 79073553
Hepatic function abnormal 148.99 9.97 182 570308 72925 79100973
Rheumatic fever 147.77 9.97 495 569995 28030 79145868
Abortion spontaneous 146.66 9.97 505 569985 29002 79144896
Neutropenia 146.20 9.97 1334 569156 286376 78887522
Pregnancy 140.02 9.97 467 570023 26384 79147514
Psoriasis 135.29 9.97 1100 569390 88487 79085411
Cardio-respiratory arrest 133.74 9.97 368 570122 108142 79065756
Fatigue 131.46 9.97 8008 562482 921719 78252179
Hypotension 131.45 9.97 2287 568203 438030 78735868
Contusion 129.80 9.97 1631 568859 147145 79026753
Serotonin syndrome 129.35 9.97 81 570409 44946 79128952
Fibromyalgia 129.35 9.97 846 569644 63494 79110404
Blood pressure systolic increased 127.57 9.97 869 569621 66117 79107781
Agitation 126.79 9.97 333 570157 99382 79074516
Infection 126.74 9.97 2431 568059 239281 78934617
Hypoglycaemia 123.38 9.97 347 570143 101247 79072651
Swollen joint count increased 123.35 9.97 403 570087 22524 79151374
Blood pressure systolic abnormal 123.03 9.97 335 570155 16912 79156986
Drug resistance 122.57 9.97 75 570415 42138 79131760
Renal impairment 122.46 9.97 646 569844 157137 79016761
Blood pressure diastolic abnormal 122.32 9.97 358 570132 18844 79155054
Cytomegalovirus infection 122.11 9.97 77 570413 42567 79131331
Drug dependence 121.81 9.97 70 570420 40699 79133199
Ill-defined disorder 119.21 9.97 844 569646 65031 79108867
Red blood cell sedimentation rate increased 117.27 9.97 643 569847 45299 79128599
Condition aggravated 115.16 9.97 4528 565962 496596 78677302
Joint effusion 112.03 9.97 333 570157 17681 79156217
Intentional product misuse 111.21 9.97 331 570159 94834 79079064
Respiratory failure 111.05 9.97 797 569693 180114 78993784
Product use in unapproved indication 108.00 9.97 1207 569283 249152 78924746
Angioedema 105.22 9.97 243 570247 75792 79098106
Poisoning 104.40 9.97 26 570464 25246 79148652
Tachycardia 102.98 9.97 796 569694 176972 78996926
Altered state of consciousness 101.58 9.97 98 570392 43724 79130174
Hepatic failure 101.54 9.97 176 570314 61036 79112862
Intentional self-injury 100.72 9.97 53 570437 32366 79141532
Grip strength decreased 99.01 9.97 363 570127 21506 79152392
Pain in extremity 98.29 9.97 3354 567136 361184 78812714
Hyperglycaemia 97.96 9.97 224 570266 70111 79103787
Rash 97.30 9.97 5063 565427 573295 78600603
Blood cholesterol increased 97.22 9.97 971 569519 82749 79091149
Neoplasm progression 95.78 9.97 138 570352 51544 79122354
Disseminated intravascular coagulation 95.56 9.97 70 570420 35772 79138126
Inflammation 95.08 9.97 1058 569432 92695 79081203
Respiratory depression 93.78 9.97 40 570450 27590 79146308
Injection site erythema 93.75 9.97 913 569577 77284 79096614
Somnolence 92.76 9.97 1179 569311 237802 78936096
Shock 92.38 9.97 105 570385 43443 79130455
C-reactive protein increased 90.29 9.97 1360 569130 127667 79046231
Blood pressure diastolic decreased 89.64 9.97 441 570049 29775 79144123
Intentional product use issue 89.52 9.97 1558 568932 150554 79023344
Foot deformity 89.06 9.97 375 570115 23699 79150199
Enthesopathy 88.39 9.97 231 570259 11377 79162521
Musculoskeletal pain 87.92 9.97 1119 569371 101235 79072663
Metabolic acidosis 87.37 9.97 300 570190 82229 79091669
Thrombocytopenia 85.52 9.97 1358 569132 263901 78909997
Disability assessment scale score increased 84.92 9.97 114 570376 3344 79170554
Osteoporosis 84.72 9.97 670 569820 53442 79120456
Hyperhidrosis 83.73 9.97 687 569803 150805 79023093
Rheumatoid nodule 83.67 9.97 295 570195 17143 79156755
Stomatitis 83.46 9.97 1495 568995 145262 79028636
Cholestasis 80.93 9.97 156 570334 51953 79121945
Ventricular tachycardia 80.68 9.97 109 570381 41826 79132072
Blood creatine phosphokinase increased 79.30 9.97 227 570263 65863 79108035
Syncope 78.19 9.97 863 569627 178586 78995312
Live birth 78.12 9.97 303 570187 18441 79155457
Gastrointestinal disorder 77.49 9.97 1267 569223 120938 79052960
Cerebral haemorrhage 76.87 9.97 188 570302 57485 79116413
Hyperkalaemia 76.64 9.97 491 569999 113907 79059991
Bone erosion 76.43 9.97 291 570199 17556 79156342
Heart rate decreased 76.14 9.97 804 569686 69512 79104386
Hepatocellular injury 76.10 9.97 140 570350 47453 79126445
Sedation complication 75.57 9.97 11 570479 15658 79158240
Juvenile idiopathic arthritis 75.49 9.97 128 570362 4635 79169263
Tenosynovitis 74.52 9.97 263 570227 15291 79158607
Multiple organ dysfunction syndrome 73.64 9.97 530 569960 119716 79054182
Cognitive disorder 72.13 9.97 257 570233 69669 79104229
Myocardial infarction 71.57 9.97 908 569582 183221 78990677
Joint stiffness 71.47 9.97 519 569971 40311 79133587
Injection site reaction 70.31 9.97 649 569841 54136 79119762
Tuberculosis 70.26 9.97 254 570236 14944 79158954
Anaphylactic shock 69.82 9.97 93 570397 35903 79137995
Joint range of motion decreased 69.57 9.97 442 570048 32840 79141058
Neuroleptic malignant syndrome 69.44 9.97 57 570433 27502 79146396
Injection site pruritus 68.66 9.97 528 569962 41755 79132143
Polyarthritis 67.91 9.97 217 570273 11985 79161913
Drug withdrawal syndrome 67.03 9.97 90 570400 34628 79139270
Cardiac failure congestive 66.84 9.97 673 569817 141729 79032169
Drug ineffective for unapproved indication 66.74 9.97 169 570321 51069 79122829
Caesarean section 66.23 9.97 219 570271 12316 79161582
Joint destruction 66.11 9.97 137 570353 5788 79168110
Post transplant lymphoproliferative disorder 65.94 9.97 4 570486 11460 79162438
Electrocardiogram QT prolonged 62.57 9.97 384 570106 90002 79083896
Leukopenia 62.28 9.97 533 569957 115980 79057918
Basal cell carcinoma 61.40 9.97 468 570022 36907 79136991
Hypothermia 61.19 9.97 44 570446 22702 79151196
Pulmonary fibrosis 60.93 9.97 531 569959 43581 79130317
Hyponatraemia 60.86 9.97 900 569590 176948 78996950
Hypoxia 60.84 9.97 460 570030 102783 79071115
Constipation 60.31 9.97 1552 568938 281498 78892400
Venoocclusive liver disease 59.80 9.97 7 570483 11764 79162134
Localised infection 59.78 9.97 467 570023 37108 79136790
Joint laxity 58.67 9.97 78 570412 2266 79171632
Cytokine release syndrome 58.35 9.97 105 570385 35893 79138005
Hallucination 57.95 9.97 367 570123 85378 79088520
Orthostatic hypotension 57.54 9.97 207 570283 55957 79117941
Agranulocytosis 57.52 9.97 150 570340 44880 79129018
Loss of personal independence in daily activities 57.25 9.97 1042 569448 101538 79072360
Injection site pain 56.87 9.97 1272 569218 128566 79045332
Acute hepatic failure 55.21 9.97 81 570409 30032 79143866
Posterior reversible encephalopathy syndrome 55.06 9.97 64 570426 26217 79147681
Nodule 54.82 9.97 316 570174 22678 79151220
Drug ineffective 54.71 9.97 8664 561826 1072249 78101649
Mydriasis 54.58 9.97 29 570461 17614 79156284
Encephalopathy 54.49 9.97 272 570218 67125 79106773
Gestational diabetes 53.95 9.97 131 570359 6162 79167736
Mobility decreased 53.53 9.97 1197 569293 120978 79052920
Second primary malignancy 53.33 9.97 18 570472 14332 79159566
Pathogen resistance 53.28 9.97 18 570472 14324 79159574
Injection site swelling 52.95 9.97 543 569947 46589 79127309
Delirium 52.78 9.97 371 570119 84256 79089642
Melaena 52.58 9.97 240 570250 60650 79113248
Neurotoxicity 52.57 9.97 95 570395 32423 79141475
Cerebral infarction 52.54 9.97 160 570330 45516 79128382
Tendonitis 52.01 9.97 320 570170 23510 79150388
Substance abuse 51.68 9.97 7 570483 10519 79163379
Suicidal ideation 51.46 9.97 327 570163 76013 79097885
Blood pressure diastolic increased 51.08 9.97 223 570267 14319 79159579
Disturbance in attention 50.88 9.97 189 570301 50612 79123286
Drug level increased 50.71 9.97 132 570358 39519 79134379
Thrombotic microangiopathy 50.46 9.97 42 570448 20127 79153771
Disorientation 50.38 9.97 254 570236 62522 79111376
Disability 50.17 9.97 249 570241 16871 79157027
Blood pressure increased 50.09 9.97 1917 568573 209443 78964455
Red blood cell sedimentation rate 50.03 9.97 118 570372 5447 79168451
Restlessness 49.89 9.97 168 570322 46324 79127574
Torsade de pointes 49.84 9.97 39 570451 19273 79154625
Tongue disorder 49.61 9.97 215 570275 13760 79160138
Latent tuberculosis 49.08 9.97 87 570403 3266 79170632
Ejection fraction decreased 49.05 9.97 109 570381 34468 79139430
Adverse event 49.05 9.97 652 569838 59562 79114336
Dehydration 48.90 9.97 1376 569114 246811 78927087
Tremor 48.85 9.97 889 569601 169194 79004704
Miosis 48.77 9.97 26 570464 15763 79158135
Body temperature decreased 48.67 9.97 395 570095 31750 79142148
Asphyxia 48.52 9.97 12 570478 11708 79162190
Myalgia 48.52 9.97 986 569504 184655 78989243
Abnormal behaviour 48.31 9.97 119 570371 36302 79137596
Oropharyngeal pain 48.10 9.97 1072 569418 108281 79065617
Rash maculo-papular 47.84 9.97 222 570268 55856 79118042
Alanine aminotransferase abnormal 47.82 9.97 156 570334 8711 79165187
Aspergillus infection 47.82 9.97 40 570450 19121 79154777
No adverse event 47.42 9.97 124 570366 37068 79136830
Myoclonus 47.28 9.97 78 570412 27582 79146316
Creatinine renal clearance decreased 47.02 9.97 40 570450 18962 79154936
Drug use disorder 46.94 9.97 4 570486 8647 79165251
Laryngitis 46.80 9.97 233 570257 15806 79158092
Speech disorder 46.77 9.97 215 570275 54230 79119668
Type 2 diabetes mellitus 46.73 9.97 619 569871 56503 79117395
Eosinophilia 46.54 9.97 167 570323 45178 79128720
Wrong technique in product usage process 46.00 9.97 324 570166 73551 79100347
Neutrophil count decreased 45.78 9.97 440 570050 93519 79080379
Withdrawal syndrome 45.65 9.97 76 570414 26778 79147120
Extrapyramidal disorder 45.63 9.97 57 570433 22622 79151276
Acute respiratory distress syndrome 45.42 9.97 162 570328 43905 79129993
Akathisia 45.31 9.97 19 570471 13240 79160658
Anaphylactic reaction 45.24 9.97 382 570108 83361 79090537
Acute graft versus host disease 44.93 9.97 9 570481 10158 79163740
Femur fracture 44.71 9.97 448 570042 38204 79135694
Maternal exposure before pregnancy 44.05 9.97 97 570393 4276 79169622
Atrial fibrillation 44.02 9.97 1078 569412 196808 78977090
Appendicolith 43.94 9.97 148 570342 8403 79165495
Bronchopulmonary aspergillosis 43.85 9.97 57 570433 22237 79151661
Ear infection 43.73 9.97 407 570083 34025 79139873
Loss of consciousness 43.59 9.97 893 569597 167050 79006848
Palmar-plantar erythrodysaesthesia syndrome 43.37 9.97 109 570381 33025 79140873
Aggression 43.31 9.97 202 570288 50756 79123142
Tumour lysis syndrome 43.30 9.97 65 570425 23874 79150024
Osteonecrosis of jaw 43.17 9.97 161 570329 43065 79130833
Mucormycosis 43.12 9.97 5 570485 8464 79165434
Injection site bruising 42.60 9.97 465 570025 40537 79133361
Dyspnoea 42.39 9.97 5428 565062 851597 78322301
Transplant rejection 42.17 9.97 46 570444 19391 79154507
Haematotoxicity 41.77 9.97 30 570460 15489 79158409
Blood creatinine increased 41.58 9.97 820 569670 154237 79019661
Seizure 41.37 9.97 1031 569459 187803 78986095
Gamma-glutamyltransferase increased 41.21 9.97 226 570264 54454 79119444
Anaemia 41.14 9.97 2687 567803 442328 78731570
Tenderness 41.08 9.97 300 570190 23342 79150556
Respiratory distress 40.82 9.97 247 570243 58092 79115806
Exposure to toxic agent 40.70 9.97 8 570482 9150 79164748
Synovial cyst 40.56 9.97 161 570329 9904 79163994
Exostosis 40.40 9.97 232 570258 16626 79157272
Coronary artery disease 40.36 9.97 288 570202 65186 79108712
Neck mass 40.26 9.97 94 570396 4310 79169588
Unresponsive to stimuli 40.20 9.97 234 570256 55554 79118344
Coagulopathy 40.09 9.97 128 570362 35878 79138020
Hypokalaemia 40.07 9.97 757 569733 143283 79030615
Ischaemic stroke 39.59 9.97 114 570376 33017 79140881
Pre-eclampsia 38.99 9.97 125 570365 6916 79166982
Inappropriate antidiuretic hormone secretion 38.95 9.97 81 570409 26232 79147666
Blood glucose increased 38.91 9.97 583 569907 114392 79059506
Diabetic ketoacidosis 38.91 9.97 120 570370 34002 79139896
Acute generalised exanthematous pustulosis 38.37 9.97 40 570450 17214 79156684
Neck deformity 38.32 9.97 56 570434 1781 79172117
Unintentional medical device removal 38.17 9.97 5 570485 7707 79166191
Blood parathyroid hormone decreased 38.10 9.97 163 570327 10373 79163525
Proteinuria 37.99 9.97 113 570377 32389 79141509
Bursitis 37.93 9.97 408 570082 35436 79138462
Accidental overdose 37.87 9.97 150 570340 39431 79134467
Acute chest syndrome 37.63 9.97 51 570439 1510 79172388
Arrhythmia 37.53 9.97 270 570220 61002 79112896
Colorectal cancer 37.50 9.97 8 570482 8639 79165259
Psychotic disorder 37.06 9.97 161 570329 41241 79132657
Asthma 36.96 9.97 712 569778 134383 79039515
Immune reconstitution inflammatory syndrome 36.94 9.97 27 570463 13814 79160084
Skin ulcer 36.79 9.97 568 569922 53582 79120316
Gastroenteritis viral 36.45 9.97 303 570187 24528 79149370
Premature delivery 36.41 9.97 290 570200 23177 79150721
Pulmonary oedema 36.24 9.97 430 570060 87824 79086074
Premature labour 36.09 9.97 137 570353 8253 79165645
Injection site rash 36.02 9.97 236 570254 17718 79156180
Haemophagocytic lymphohistiocytosis 36.02 9.97 63 570427 21774 79152124
Stevens-Johnson syndrome 35.86 9.97 151 570339 39015 79134883
Anxiety 35.73 9.97 1434 569056 247078 78926820
Hyperthermia 35.60 9.97 46 570444 17991 79155907
Arthritis infective 35.53 9.97 135 570355 8136 79165762
Lupus-like syndrome 35.39 9.97 194 570296 13663 79160235
Fracture 35.26 9.97 272 570218 21529 79152369
Bradyphrenia 35.17 9.97 16 570474 10624 79163274
Vision blurred 35.14 9.97 539 569951 105359 79068539
Interstitial lung disease 35.06 9.97 580 569910 112020 79061878
Stress cardiomyopathy 35.06 9.97 18 570472 11148 79162750
Balance disorder 34.94 9.97 497 569993 98360 79075538
Granuloma skin 34.79 9.97 144 570346 9030 79164868
Angina pectoris 34.65 9.97 222 570268 51510 79122388
BK virus infection 34.58 9.97 10 570480 8794 79165104
Multiple fractures 34.48 9.97 131 570359 7895 79166003
Graft versus host disease 34.36 9.97 34 570456 14992 79158906
Forced expiratory volume decreased 34.36 9.97 7 570483 7807 79166091
Peripheral venous disease 34.32 9.97 213 570277 15696 79158202
Pancreatitis acute 34.19 9.97 211 570279 49393 79124505
Ankylosing spondylitis 33.99 9.97 175 570315 12030 79161868
Gastrointestinal haemorrhage 33.86 9.97 801 569689 146918 79026980
Erythema multiforme 33.83 9.97 46 570444 17605 79156293
Haemorrhage intracranial 33.64 9.97 87 570403 26106 79147792
Tachypnoea 33.63 9.97 117 570373 31946 79141952
Facet joint syndrome 33.55 9.97 165 570325 11137 79162761
Myelosuppression 33.51 9.97 161 570329 40135 79133763
Disease recurrence 33.41 9.97 182 570308 43927 79129971
Mental status changes 33.28 9.97 312 570178 66647 79107251
Dystonia 33.28 9.97 64 570426 21335 79152563
Wheelchair user 33.17 9.97 108 570382 6024 79167874
Joint dislocation 32.98 9.97 221 570269 16718 79157180
Vomiting 32.50 9.97 4220 566270 661608 78512290
Joint injury 32.38 9.97 355 570135 30980 79142918
Dysarthria 32.37 9.97 318 570172 67304 79106594
Lip dry 32.37 9.97 205 570285 15213 79158685
Smear cervix abnormal 32.34 9.97 62 570428 2474 79171424
Psychomotor hyperactivity 32.20 9.97 44 570446 16805 79157093
Limb deformity 32.14 9.97 76 570414 3514 79170384
Chronic kidney disease 32.13 9.97 310 570180 65844 79108054
Premature rupture of membranes 32.04 9.97 82 570408 3987 79169911
Rotator cuff repair 31.98 9.97 52 570438 1818 79172080
Spinal stenosis 31.95 9.97 208 570282 15583 79158315
Pulmonary tuberculosis 31.85 9.97 126 570364 7739 79166159
Face oedema 31.34 9.97 100 570390 28036 79145862
Maternal exposure timing unspecified 31.32 9.97 102 570388 5690 79168208
Fear of injection 31.29 9.97 121 570369 7353 79166545
Therapeutic response decreased 31.19 9.97 661 569829 66192 79107706
Cytopenia 30.80 9.97 62 570428 20321 79153577
Panniculitis 30.80 9.97 172 570318 12199 79161699
Bone disorder 30.65 9.97 238 570252 18875 79155023
Acute myocardial infarction 30.62 9.97 378 570112 76658 79097240
Cerebrovascular accident 30.56 9.97 861 569629 154431 79019467
General physical health deterioration 30.50 9.97 2325 568165 272913 78900985
Irritability 30.49 9.97 171 570319 40973 79132925
Clostridium difficile colitis 30.47 9.97 123 570367 32160 79141738
Acute myeloid leukaemia 30.22 9.97 116 570374 30769 79143129
Haemorrhage 30.16 9.97 464 570026 90654 79083244
Hepatitis B reactivation 30.13 9.97 4 570486 6104 79167794
Bronchospasm 30.10 9.97 85 570405 24774 79149124
Influenza 29.85 9.97 1172 569318 128434 79045464
Mania 29.83 9.97 53 570437 18207 79155691
Pulmonary alveolar haemorrhage 29.74 9.97 23 570467 11434 79162464
Weight decreased 29.64 9.97 2938 567552 352260 78821638
Acute graft versus host disease in skin 29.53 9.97 9 570481 7649 79166249
Polyomavirus-associated nephropathy 29.47 9.97 3 570487 5624 79168274
Brain oedema 29.41 9.97 88 570402 25175 79148723
Cytomegalovirus viraemia 29.33 9.97 29 570461 12792 79161106
Malignant mediastinal neoplasm 29.32 9.97 43 570447 1372 79172526
Retinitis 29.29 9.97 98 570392 5545 79168353
Pemphigoid 29.26 9.97 40 570450 15275 79158623
Product quality issue 29.16 9.97 134 570356 33806 79140092
Klebsiella infection 29.10 9.97 42 570448 15678 79158220
Chest discomfort 29.08 9.97 758 569732 137286 79036612
Fear 29.03 9.97 72 570418 21914 79151984
Blood alkaline phosphatase increased 28.98 9.97 303 570187 63361 79110537
Labelled drug-drug interaction medication error 28.93 9.97 101 570389 27549 79146349
Ulcer 28.91 9.97 335 570155 29637 79144261
Hallucination, auditory 28.73 9.97 66 570424 20627 79153271
Wound infection 28.69 9.97 280 570210 23711 79150187
Skin papilloma 28.60 9.97 100 570390 5786 79168112
Aphasia 28.59 9.97 206 570284 46526 79127372
Deep vein thrombosis postoperative 28.46 9.97 152 570338 10600 79163298
Anuria 28.19 9.97 68 570422 20895 79153003
Mouth ulceration 28.13 9.97 408 570082 37986 79135912
Anti-cyclic citrullinated peptide antibody 28.07 9.97 99 570391 5753 79168145
Poor venous access 28.01 9.97 224 570266 17925 79155973
Metastases to liver 27.92 9.97 106 570384 28208 79145690
Accidental exposure to product 27.91 9.97 122 570368 31200 79142698
Electrocardiogram QRS complex prolonged 27.80 9.97 22 570468 10811 79163087
Sciatica 27.58 9.97 361 570129 32861 79141037
Scleritis 27.54 9.97 81 570409 4275 79169623
Haemoglobin decreased 27.46 9.97 1893 568597 220226 78953672
Adenovirus infection 27.46 9.97 13 570477 8434 79165464
Nocardiosis 27.36 9.97 4 570486 5675 79168223
Adjustment disorder with depressed mood 27.23 9.97 133 570357 8953 79164945
Hallucination, visual 27.08 9.97 131 570359 32598 79141300
Subdural haematoma 27.07 9.97 124 570366 31310 79142588
Emotional distress 27.04 9.97 171 570319 39798 79134100
Blood pressure decreased 26.96 9.97 525 569965 98941 79074957
Sexual dysfunction 26.73 9.97 11 570479 7752 79166146
Foot fracture 26.51 9.97 257 570233 21724 79152174
Asthenia 26.42 9.97 3231 567259 508458 78665440
Urinary retention 26.40 9.97 268 570222 56362 79117536
Metastases to bone 26.39 9.97 88 570402 24339 79149559
Leukocytosis 26.36 9.97 192 570298 43263 79130635
Cyanosis 26.33 9.97 92 570398 25090 79148808
Tenosynovitis stenosans 26.31 9.97 64 570426 3014 79170884
Shock haemorrhagic 26.25 9.97 66 570424 19994 79153904
Temperature regulation disorder 26.25 9.97 5 570485 5848 79168050
Chronic graft versus host disease 26.09 9.97 8 570482 6773 79167125
Pulmonary embolism 26.08 9.97 984 569506 170670 79003228
Product administration error 26.04 9.97 128 570362 31718 79142180
Haematoma 26.03 9.97 243 570247 51952 79121946
Febrile bone marrow aplasia 25.91 9.97 33 570457 12987 79160911
Acidosis 25.87 9.97 65 570425 19697 79154201
Toxic skin eruption 25.70 9.97 78 570412 22215 79151683
Synovial fluid analysis 25.68 9.97 54 570436 2305 79171593
Sepsis 25.68 9.97 1622 568868 267806 78906092
Drug tolerance decreased 25.68 9.97 170 570320 12808 79161090
Breast cancer stage I 25.61 9.97 8 570482 6692 79167206
Muscle twitching 25.54 9.97 91 570399 24673 79149225
Dysphagia 25.36 9.97 672 569818 121464 79052434
Pyrexia 25.22 9.97 4371 566119 674338 78499560
Blood bilirubin increased 25.20 9.97 328 570162 65904 79107994
Off label use 25.18 9.97 5930 564560 901285 78272613
Dislocation of vertebra 24.81 9.97 117 570373 7763 79166135
Dermatitis acneiform 24.77 9.97 21 570469 9972 79163926
Septic shock 24.63 9.97 679 569811 122122 79051776
Hemiparesis 24.56 9.97 141 570349 33592 79140306
Device use error 24.55 9.97 10 570480 7091 79166807
Diabetes insipidus 24.52 9.97 4 570486 5233 79168665
Skin cancer 24.52 9.97 188 570302 14852 79159046
Cardiotoxicity 24.37 9.97 31 570459 12208 79161690
Hyperammonaemia 24.35 9.97 26 570464 11067 79162831
Cystitis haemorrhagic 24.34 9.97 18 570472 9154 79164744
Toxic epidermal necrolysis 24.23 9.97 203 570287 44378 79129520
Herpes zoster 24.15 9.97 853 569637 92230 79081668
Hypermethioninaemia 24.13 9.97 12 570478 75 79173823
Rheumatoid lung 24.09 9.97 76 570414 4169 79169729
Hemiplegia 23.83 9.97 44 570446 14895 79159003
Urticaria 23.82 9.97 1082 569408 184119 78989779
Pneumatosis intestinalis 23.81 9.97 8 570482 6389 79167509
Haemoptysis 23.70 9.97 271 570219 55728 79118170
Liver injury 23.64 9.97 551 569939 56063 79117835
Myocardial ischaemia 23.60 9.97 98 570392 25421 79148477
Device difficult to use 23.58 9.97 37 570453 13348 79160550
Loose body in joint 23.50 9.97 37 570453 1258 79172640
Product prescribing error 23.49 9.97 206 570284 44607 79129291
Multiple sclerosis relapse 23.48 9.97 216 570274 46317 79127581
Nausea 23.38 9.97 6293 564197 950903 78222995
Hyperthyroidism 23.32 9.97 81 570409 22128 79151770
Rhinorrhoea 23.30 9.97 711 569779 75363 79098535
Dyskinesia 22.95 9.97 207 570283 44566 79129332
Acute coronary syndrome 22.92 9.97 76 570414 21057 79152841
Finger deformity 22.82 9.97 110 570380 7364 79166534
Diarrhoea 22.76 9.97 5774 564716 874715 78299183
Hypomagnesaemia 22.71 9.97 220 570270 46691 79127207
Immunodeficiency 22.67 9.97 247 570243 21521 79152377
Jaundice 22.65 9.97 258 570232 53091 79120807
Pulmonary arterial hypertension 22.63 9.97 115 570375 28251 79145647
Fracture delayed union 22.62 9.97 48 570442 2062 79171836
Antinuclear antibody positive 22.58 9.97 114 570376 7776 79166122
Obesity 22.56 9.97 365 570125 34760 79139138
Venoocclusive disease 22.55 9.97 3 570487 4570 79169328
Epstein-Barr virus infection 22.52 9.97 43 570447 14373 79159525
Potentiating drug interaction 22.52 9.97 18 570472 8801 79165097
Injection site warmth 22.44 9.97 182 570308 14625 79159273
Lip swelling 22.37 9.97 186 570304 40725 79133173
Bronchitis 22.32 9.97 1146 569344 129498 79044400
Synovial disorder 22.30 9.97 46 570444 1937 79171961
Respiratory disorder 22.29 9.97 209 570281 44647 79129251
Malignant melanoma 22.24 9.97 181 570309 14560 79159338
Ileus 22.22 9.97 104 570386 26107 79147791
Tubulointerstitial nephritis 22.21 9.97 171 570319 38064 79135834
Cardiomyopathy 22.19 9.97 118 570372 28656 79145242
Therapy partial responder 22.18 9.97 58 570432 17339 79156559
Hyperbilirubinaemia 22.15 9.97 95 570395 24423 79149475
Cyst 22.01 9.97 172 570318 13668 79160230
Graft versus host disease in skin 21.91 9.97 8 570482 6065 79167833
Acute respiratory failure 21.87 9.97 297 570193 59244 79114654
Oliguria 21.86 9.97 53 570437 16256 79157642
Red blood cell count decreased 21.68 9.97 552 569938 56961 79116937
Joint noise 21.51 9.97 70 570420 3904 79169994
Vertigo 21.45 9.97 356 570134 68726 79105172
Hyperuricaemia 21.37 9.97 32 570458 11767 79162131
Cardiac failure chronic 21.36 9.97 29 570461 11106 79162792
Cardiac failure acute 21.28 9.97 67 570423 18862 79155036
Infective pulmonary exacerbation of cystic fibrosis 21.26 9.97 37 570453 12814 79161084
Muscle rigidity 21.22 9.97 72 570418 19810 79154088
Hydrops foetalis 21.21 9.97 27 570463 751 79173147
Anhedonia 21.10 9.97 47 570443 14851 79159047
Pancreatitis 21.09 9.97 354 570136 68221 79105677
Nephropathy toxic 21.08 9.97 75 570415 20344 79153554
Blood calcium decreased 21.08 9.97 137 570353 31682 79142216
Glycosylated haemoglobin increased 21.07 9.97 69 570421 19191 79154707
Platelet count decreased 21.03 9.97 1158 569332 193506 78980392
Pulmonary congestion 20.98 9.97 111 570379 26989 79146909
Polyneuropathy 20.96 9.97 95 570395 24056 79149842
Hyperprolactinaemia 20.96 9.97 4 570486 4672 79169226
Pseudomonas infection 20.78 9.97 78 570412 20825 79153073
Pleuritic pain 20.71 9.97 134 570356 10018 79163880
Respiratory acidosis 20.66 9.97 30 570460 11170 79162728
Polyhydramnios 20.65 9.97 41 570449 1679 79172219
Ultrasound antenatal screen 20.41 9.97 25 570465 668 79173230
Progressive multifocal leukoencephalopathy 20.39 9.97 77 570413 20523 79153375
Cleft lip and palate 20.26 9.97 25 570465 673 79173225
Virologic failure 20.08 9.97 3 570487 4188 79169710
Bladder cancer 19.98 9.97 72 570418 19454 79154444
Nasal polyps 19.94 9.97 14 570476 7313 79166585
Glomerular filtration rate decreased 19.88 9.97 89 570401 22613 79151285
Appendicitis 19.87 9.97 232 570258 20562 79153336
International normalised ratio increased 19.80 9.97 458 570032 84263 79089635
Sinus bradycardia 19.77 9.97 103 570387 25144 79148754
Pruritus genital 19.76 9.97 4 570486 4482 79169416
Pancytopenia 19.68 9.97 1408 569082 164337 79009561
Skin necrosis 19.66 9.97 207 570283 17880 79156018
Pleural effusion 19.64 9.97 844 569646 144418 79029480
Mental disorder 19.62 9.97 137 570353 31165 79142733
Cytomegalovirus infection reactivation 19.61 9.97 20 570470 8696 79165202
Eosinophil count increased 19.61 9.97 60 570430 17045 79156853
Sleep terror 19.59 9.97 4 570486 4454 79169444
Pulmonary haemorrhage 19.59 9.97 48 570442 14669 79159229
Flushing 19.57 9.97 481 570009 87787 79086111
Obstructive airways disorder 19.57 9.97 138 570352 31321 79142577
Human antichimeric antibody positive 19.56 9.97 39 570451 1602 79172296
Compartment syndrome 19.55 9.97 6 570484 5076 79168822
Haematemesis 19.45 9.97 260 570230 52004 79121894
Normal newborn 19.42 9.97 101 570389 6971 79166927
Transplant dysfunction 19.38 9.97 14 570476 7207 79166691
Multiple drug therapy 19.35 9.97 3 570487 4075 79169823
Hypernatraemia 19.34 9.97 47 570443 14404 79159494
Purpura 19.32 9.97 73 570417 19454 79154444
Dizziness 19.25 9.97 3393 567097 523048 78650850
Hyperlactacidaemia 19.15 9.97 8 570482 5587 79168311
Hypertransaminasaemia 19.13 9.97 35 570455 11889 79162009
Jaundice cholestatic 19.12 9.97 32 570458 11252 79162646
Ingrown hair 19.08 9.97 25 570465 716 79173182
Blood lactic acid increased 19.06 9.97 39 570451 12705 79161193
Oral herpes 19.04 9.97 289 570201 27165 79146733
Haematocrit decreased 19.04 9.97 574 569916 60738 79113160
Pulseless electrical activity 18.99 9.97 46 570444 14114 79159784
Osteopenia 18.95 9.97 208 570282 18156 79155742
Lymphocyte count decreased 18.80 9.97 232 570258 47057 79126841
Heparin-induced thrombocytopenia 18.79 9.97 25 570465 9657 79164241
Maternal exposure during breast feeding 18.78 9.97 53 570437 2732 79171166
Lower limb fracture 18.75 9.97 251 570239 22964 79150934
Rash pruritic 18.73 9.97 657 569833 70972 79102926
Oxygen saturation decreased 18.70 9.97 1115 569375 127932 79045966
Hypoxic-ischaemic encephalopathy 18.70 9.97 17 570473 7803 79166095
Gastric haemorrhage 18.56 9.97 51 570439 14999 79158899
Accidental death 18.55 9.97 4 570486 4287 79169611
Cytomegalovirus chorioretinitis 18.55 9.97 8 570482 5482 79168416
Palpitations 18.52 9.97 729 569761 125881 79048017
Haemodynamic instability 18.52 9.97 63 570427 17319 79156579
Parkinsonism 18.43 9.97 59 570431 16525 79157373
Polyuria 18.43 9.97 51 570439 14963 79158935
Oesophageal carcinoma 18.26 9.97 32 570458 11052 79162846
Hepatitis acute 18.19 9.97 54 570436 15488 79158410
Fluid retention 18.15 9.97 371 570119 69438 79104460
Rebound effect 18.14 9.97 15 570475 7211 79166687
Ventricular arrhythmia 18.01 9.97 22 570468 8818 79165080
Pneumonia aspiration 17.98 9.97 354 570136 66613 79107285
Trisomy 18 17.98 9.97 22 570468 587 79173311
Myocarditis 17.97 9.97 87 570403 21646 79152252
Subarachnoid haemorrhage 17.95 9.97 102 570388 24363 79149535
Ankle arthroplasty 17.89 9.97 36 570454 1489 79172409
Tardive dyskinesia 17.89 9.97 30 570460 10541 79163357
Postoperative wound infection 17.88 9.97 156 570334 12805 79161093
Body height below normal 17.88 9.97 43 570447 2010 79171888
Post procedural infection 17.84 9.97 141 570349 11243 79162655
Colitis ulcerative 17.68 9.97 348 570142 34394 79139504
Catatonia 17.62 9.97 22 570468 8734 79165164
Hypothyroidism 17.60 9.97 266 570224 52126 79121772
Bacteraemia 17.60 9.97 150 570340 32674 79141224
Cholangitis 17.53 9.97 41 570449 12735 79161163
Upper respiratory tract infection 17.52 9.97 809 569681 90359 79083539
COVID-19 17.39 9.97 936 569554 156738 79017160
Depression 17.36 9.97 1325 569165 215465 78958433
Nightmare 17.31 9.97 111 570379 25750 79148148
Device leakage 17.29 9.97 32 570458 10824 79163074
Enterocolitis 17.29 9.97 50 570440 14462 79159436
COVID-19 pneumonia 17.24 9.97 128 570362 28721 79145177
Lymphopenia 17.13 9.97 138 570352 30419 79143479
Erectile dysfunction 17.13 9.97 51 570439 14613 79159285
Autoimmune disorder 17.07 9.97 188 570302 16424 79157474
Decreased appetite 17.04 9.97 2167 568323 340251 78833647
Hepatitis cholestatic 17.04 9.97 47 570443 13805 79160093
Cross sensitivity reaction 17.01 9.97 3 570487 3709 79170189
Knee operation 16.96 9.97 85 570405 5781 79168117
Hepatocellular carcinoma 16.80 9.97 24 570466 8997 79164901
Drug tolerance 16.78 9.97 113 570377 8562 79165336
Breast feeding 16.77 9.97 23 570467 689 79173209
Deformity 16.75 9.97 122 570368 9483 79164415
Neck pain 16.66 9.97 679 569811 74738 79099160
Metastases to lung 16.64 9.97 70 570420 18093 79155805
Short stature 16.64 9.97 23 570467 694 79173204
Affective disorder 16.64 9.97 21 570469 8298 79165600
Alcohol interaction 16.63 9.97 7 570483 4867 79169031
Skin toxicity 16.62 9.97 21 570469 8293 79165605
Foetal distress syndrome 16.56 9.97 19 570471 473 79173425
Atrial tachycardia 16.47 9.97 16 570474 7117 79166781
Circulatory collapse 16.45 9.97 181 570309 37487 79136411
Aplasia 16.43 9.97 19 570471 7801 79166097
Schizophrenia 16.42 9.97 56 570434 15384 79158514
Hypercapnia 16.41 9.97 24 570466 8911 79164987
Pharyngitis streptococcal 16.40 9.97 132 570358 10582 79163316
Blood lactate dehydrogenase increased 16.40 9.97 190 570300 38980 79134918
Personality disorder 16.39 9.97 12 570478 6134 79167764
Diabetes mellitus inadequate control 16.31 9.97 104 570386 24160 79149738
Left ventricular dysfunction 16.30 9.97 77 570413 19284 79154614
Hydrocephalus 16.26 9.97 24 570466 8876 79165022
Sinus tachycardia 16.26 9.97 177 570313 36731 79137167
Onychomycosis 16.22 9.97 108 570382 8153 79165745
Immune effector cell-associated neurotoxicity syndrome 16.14 9.97 11 570479 5837 79168061
Placental disorder 16.03 9.97 26 570464 907 79172991
Injection site urticaria 15.98 9.97 151 570339 12675 79161223
Drug screen positive 15.96 9.97 12 570478 6051 79167847
Coronary artery bypass 15.95 9.97 12 570478 6050 79167848
Paranoia 15.95 9.97 78 570412 19354 79154544
Induced labour 15.94 9.97 25 570465 847 79173051
Hepatic cancer 15.93 9.97 32 570458 10497 79163401
Bradypnoea 15.90 9.97 12 570478 6040 79167858
Injection site haemorrhage 15.85 9.97 284 570206 27586 79146312
Foot operation 15.83 9.97 82 570408 5651 79168247
Toothache 15.75 9.97 215 570275 19755 79154143
Metastases to central nervous system 15.70 9.97 62 570428 16313 79157585
Delusion 15.61 9.97 84 570406 20339 79153559
Heart rate irregular 15.53 9.97 324 570166 32355 79141543
White blood cell count decreased 15.52 9.97 1148 569342 187140 78986758
Bronchial secretion retention 15.51 9.97 5 570485 4099 79169799
Endodontic procedure 15.46 9.97 49 570441 2694 79171204
Device expulsion 15.33 9.97 115 570375 25746 79148152
Prescribed overdose 15.29 9.97 367 570123 37516 79136382
Surgery 15.29 9.97 324 570166 32442 79141456
Persecutory delusion 15.29 9.97 8 570482 4901 79168997
Paralysis 15.27 9.97 46 570444 13131 79160767
Radiation inflammation 15.25 9.97 25 570465 880 79173018
Atrioventricular block complete 15.23 9.97 64 570426 16546 79157352
Right ventricular failure 15.15 9.97 102 570388 23395 79150503
Acute graft versus host disease in intestine 15.14 9.97 5 570485 4036 79169862
Anti-neutrophil cytoplasmic antibody positive vasculitis 15.09 9.97 4 570486 3725 79170173
Coordination abnormal 15.08 9.97 68 570422 17244 79156654
Sleep disorder due to a general medical condition 15.04 9.97 52 570438 14225 79159673
Status epilepticus 15.02 9.97 111 570379 24930 79148968
Hypoaesthesia 15.00 9.97 1484 569006 177868 78996030
Depressed mood 14.99 9.97 250 570240 48230 79125668
Brain injury 14.99 9.97 38 570452 11479 79162419
Stress 14.98 9.97 705 569785 78907 79094991
Dry eye 14.98 9.97 358 570132 36573 79137325
Sickle cell anaemia 14.96 9.97 21 570469 643 79173255
Musculoskeletal disorder 14.96 9.97 226 570264 21222 79152676
Injury 14.96 9.97 688 569802 76808 79097090
Antibody test positive 14.95 9.97 49 570441 2743 79171155
Acute myeloid leukaemia recurrent 14.94 9.97 3 570487 3380 79170518
Stillbirth 14.93 9.97 62 570428 3893 79170005
Immunosuppressant drug level increased 14.93 9.97 26 570464 9001 79164897
Atrioventricular block 14.88 9.97 51 570439 13990 79159908
Laryngospasm 14.88 9.97 5 570485 3992 79169906
Rhinitis allergic 14.82 9.97 42 570448 12227 79161671
Tooth disorder 14.81 9.97 267 570223 25966 79147932
Cushingoid 14.80 9.97 118 570372 9434 79164464
Renal disorder 14.76 9.97 212 570278 41893 79132005
Generalised oedema 14.75 9.97 104 570386 23605 79150293
Haematuria 14.75 9.97 377 570113 68459 79105439
Frequent bowel movements 14.74 9.97 295 570195 29244 79144654
Abortion missed 14.71 9.97 30 570460 1253 79172645
Pain in jaw 14.60 9.97 237 570253 45914 79127984
Vitamin B6 increased 14.60 9.97 6 570484 22 79173876
Hyperlipidaemia 14.55 9.97 118 570372 25975 79147923
Hepatic encephalopathy 14.55 9.97 107 570383 24059 79149839
Diaphragmatic disorder 14.54 9.97 36 570454 1714 79172184
Device related infection 14.50 9.97 166 570324 34128 79139770
Drug abuser 14.46 9.97 13 570477 6000 79167898
Capillary leak syndrome 14.45 9.97 5 570485 3920 79169978
Lacrimal disorder 14.41 9.97 18 570472 491 79173407
Hypertriglyceridaemia 14.39 9.97 45 570445 12695 79161203
Anticholinergic syndrome 14.37 9.97 4 570486 3607 79170291
Drug hypersensitivity 14.35 9.97 1896 568594 297020 78876878
Lymph gland infection 14.24 9.97 19 570471 554 79173344
Respiration abnormal 14.23 9.97 21 570469 7767 79166131
Dry mouth 14.20 9.97 768 569722 87251 79086647
Breast abscess 14.19 9.97 32 570458 1434 79172464
Joint lock 14.15 9.97 53 570437 3172 79170726
Metastasis 14.15 9.97 17 570473 6863 79167035
Anal fissure 14.11 9.97 99 570391 7604 79166294
Renal tubular necrosis 14.07 9.97 113 570377 24926 79148972
Bone density abnormal 14.03 9.97 51 570439 3009 79170889
Dysgeusia 13.95 9.97 307 570183 56870 79117028
Type I hypersensitivity 13.94 9.97 7 570483 4391 79169507
Dyslipidaemia 13.92 9.97 40 570450 11593 79162305
Neuropathy peripheral 13.92 9.97 848 569642 140457 79033441
Cervical incompetence 13.91 9.97 18 570472 509 79173389
Bone cyst 13.90 9.97 55 570435 3378 79170520
Haemorrhage in pregnancy 13.83 9.97 31 570459 1383 79172515
Incoherent 13.80 9.97 21 570469 7671 79166227
Pulmonary pain 13.78 9.97 66 570424 4407 79169491
Prostatic specific antigen increased 13.72 9.97 34 570456 10352 79163546
Hyperpyrexia 13.69 9.97 14 570476 6078 79167820
Hypocalcaemia 13.68 9.97 263 570227 49661 79124237
Injection site extravasation 13.67 9.97 117 570373 9552 79164346
Spinal osteoarthritis 13.66 9.97 183 570307 16744 79157154
Human herpesvirus 6 infection 13.66 9.97 11 570479 5359 79168539
Ketoacidosis 13.56 9.97 22 570468 7832 79166066
Dactylitis 13.54 9.97 47 570443 2710 79171188
Intestinal ischaemia 13.53 9.97 49 570441 13221 79160677
Hypoalbuminaemia 13.45 9.97 93 570397 21204 79152694
Coronary arterial stent insertion 13.45 9.97 14 570476 6030 79167868
Hepatic cirrhosis 13.44 9.97 336 570154 34570 79139328
Foetal exposure during pregnancy 13.43 9.97 79 570411 5711 79168187
Walking aid user 13.41 9.97 121 570369 10027 79163871
Bone pain 13.40 9.97 300 570190 55442 79118456
Osteoporotic fracture 13.38 9.97 63 570427 4177 79169721
Drug dose omission by device 13.33 9.97 15 570475 6235 79167663
Tuberculin test positive 13.32 9.97 54 570436 3354 79170544
Intervertebral disc degeneration 13.30 9.97 172 570318 15613 79158285
Lymphatic fistula 13.29 9.97 22 570468 781 79173117
Toxic optic neuropathy 13.27 9.97 27 570463 1126 79172772
Pulmonary hypertension 13.26 9.97 253 570237 47827 79126071
Presyncope 13.26 9.97 210 570280 40844 79133054
Feeling abnormal 13.22 9.97 970 569520 158229 79015669
End stage renal disease 13.22 9.97 44 570446 12176 79161722
Acute lung injury 13.18 9.97 3 570487 3097 79170801
Vascular purpura 13.16 9.97 3 570487 3095 79170803
Skin exfoliation 13.12 9.97 297 570193 54803 79119095
Wound infection pseudomonas 13.11 9.97 33 570457 1588 79172310
Endophthalmitis 13.10 9.97 16 570474 6412 79167486
Generalised tonic-clonic seizure 13.07 9.97 228 570262 43682 79130216
Lower respiratory tract congestion 13.06 9.97 60 570430 3937 79169961
Psychiatric decompensation 13.03 9.97 6 570484 3957 79169941
Congestive cardiomyopathy 13.03 9.97 42 570448 11738 79162160
Long QT syndrome 13.02 9.97 14 570476 5941 79167957
Abortion incomplete 12.95 9.97 3 570487 3061 79170837
Acute pulmonary oedema 12.94 9.97 55 570435 14175 79159723
Salivary hypersecretion 12.92 9.97 55 570435 14169 79159729
Reversible cerebral vasoconstriction syndrome 12.91 9.97 3 570487 3054 79170844
Colitis microscopic 12.90 9.97 37 570453 10731 79163167
Carotid artery thrombosis 12.89 9.97 3 570487 3050 79170848
Gastroenteritis 12.81 9.97 327 570163 33755 79140143
Cell death 12.76 9.97 9 570481 4690 79169208
Renal injury 12.73 9.97 70 570420 16857 79157041
Clear cell renal cell carcinoma 12.72 9.97 44 570446 2532 79171366
Cellulitis 12.69 9.97 925 569565 108135 79065763
Hypervitaminosis 12.69 9.97 6 570484 33 79173865
C-reactive protein decreased 12.68 9.97 45 570445 2623 79171275
Ligament rupture 12.65 9.97 53 570437 3341 79170557
Tooth infection 12.58 9.97 197 570293 18635 79155263
Lip blister 12.58 9.97 46 570444 2721 79171177
Sensitisation 12.57 9.97 4 570486 3307 79170591
Ventricular hypokinesia 12.56 9.97 30 570460 9249 79164649
Pulmonary function test abnormal 12.54 9.97 7 570483 4137 79169761
Femoral hernia incarcerated 12.52 9.97 22 570468 820 79173078
Lipase increased 12.44 9.97 68 570422 16398 79157500
Alcohol abuse 12.42 9.97 12 570478 5351 79168547
Pneumonia bacterial 12.42 9.97 84 570406 19247 79154651
Inadequate analgesia 12.39 9.97 9 570481 4620 79169278
Amylase increased 12.37 9.97 40 570450 11169 79162729
Renal tubular disorder 12.33 9.97 17 570473 6469 79167429
Peritoneal dialysis complication 12.32 9.97 41 570449 2313 79171585
Cholestasis of pregnancy 12.32 9.97 24 570466 969 79172929
Type 1 diabetes mellitus 12.31 9.97 19 570471 6900 79166998
Immunosuppression 12.30 9.97 143 570347 12660 79161238
Road traffic accident 12.30 9.97 404 570086 43260 79130638
C-reactive protein 12.24 9.97 69 570421 4910 79168988
Troponin increased 12.20 9.97 84 570406 19171 79154727
Oligoarthritis 12.20 9.97 20 570470 704 79173194
Gastric cancer 12.18 9.97 35 570455 10144 79163754
Epstein-Barr virus associated lymphoproliferative disorder 12.17 9.97 5 570485 3527 79170371
Tooth abscess 12.17 9.97 173 570317 16037 79157861
Small for dates baby 12.16 9.97 16 570474 460 79173438
Blood folate increased 12.15 9.97 17 570473 519 79173379
Accidental exposure to product by child 12.11 9.97 3 570487 2923 79170975
Angina unstable 12.08 9.97 69 570421 16458 79157440
Myofascial pain syndrome 12.05 9.97 37 570453 2000 79171898
Joint warmth 12.04 9.97 32 570458 1592 79172306
Human anti-human antibody test 12.04 9.97 15 570475 408 79173490
Intestinal stenosis 12.01 9.97 56 570434 3698 79170200
Neurologic neglect syndrome 11.99 9.97 3 570487 2904 79170994
Chest pain 11.98 9.97 1804 568686 280500 78893398
Abortion threatened 11.98 9.97 15 570475 410 79173488
Ischaemic cardiomyopathy 11.98 9.97 23 570467 7672 79166226
Euglycaemic diabetic ketoacidosis 11.98 9.97 19 570471 6825 79167073
Dyspnoea exertional 11.95 9.97 505 569985 86568 79087330
Gestational hypertension 11.94 9.97 35 570455 1844 79172054
Visual acuity reduced 11.93 9.97 144 570346 29325 79144573
Hepatitis E antibody positive 11.93 9.97 12 570478 256 79173642
Spondylitis 11.92 9.97 66 570424 4665 79169233
Systemic inflammatory response syndrome 11.91 9.97 42 570448 11423 79162475
Renal cancer 11.91 9.97 46 570444 12180 79161718
Product monitoring error 11.89 9.97 29 570461 8877 79165021
Polydipsia 11.88 9.97 18 570472 6587 79167311
Cyst rupture 11.88 9.97 19 570471 655 79173243
Neutropenic colitis 11.84 9.97 14 570476 5693 79168205
Eye infection 11.84 9.97 134 570356 11786 79162112
Therapy non-responder 11.80 9.97 789 569701 91516 79082382
Psychomotor skills impaired 11.80 9.97 12 570478 5225 79168673
Extradural haematoma 11.80 9.97 3 570487 2873 79171025
Accessory spleen 11.79 9.97 11 570479 213 79173685
Bone marrow failure 11.74 9.97 277 570213 50830 79123068
Arthropod bite 11.71 9.97 102 570388 8369 79165529
Acute lymphocytic leukaemia recurrent 11.62 9.97 10 570480 4714 79169184
Blood urea increased 11.61 9.97 263 570227 48527 79125371
Nephrolithiasis 11.59 9.97 479 570011 52812 79121086
Sudden death 11.57 9.97 104 570386 22407 79151491
Threatened labour 11.56 9.97 18 570472 606 79173292
Panic attack 11.54 9.97 114 570376 24102 79149796
Kidney infection 11.50 9.97 220 570270 21631 79152267
Oesophageal fibrosis 11.50 9.97 10 570480 176 79173722
Nail injury 11.48 9.97 18 570472 610 79173288
Myopathy 11.46 9.97 93 570397 20470 79153428
Transaminases increased 11.46 9.97 282 570208 51461 79122437
Joint ankylosis 11.44 9.97 38 570452 2142 79171756
Anal fistula 11.43 9.97 87 570403 6857 79167041
Spinal disorder 11.42 9.97 118 570372 10142 79163756
Placental insufficiency 11.41 9.97 25 570465 1098 79172800
Sinus congestion 11.41 9.97 203 570287 19693 79154205
Dry skin 11.41 9.97 385 570105 67610 79106288
Drug specific antibody 11.38 9.97 43 570447 2585 79171313
Eating disorder 11.36 9.97 94 570396 20603 79153295
Pharyngitis 11.35 9.97 224 570266 22151 79151747
Defaecation disorder 11.32 9.97 19 570471 682 79173216
Genital haemorrhage 11.30 9.97 17 570473 6238 79167660
Cerebral haematoma 11.29 9.97 25 570465 7917 79165981
Procedural pain 11.28 9.97 108 570382 22976 79150922
Butterfly rash 11.17 9.97 32 570458 1664 79172234
Product administered to patient of inappropriate age 11.13 9.97 14 570476 5539 79168359
Bronchopulmonary aspergillosis allergic 11.10 9.97 4 570486 3057 79170841
Cartilage injury 11.03 9.97 30 570460 1513 79172385
Aphthous ulcer 11.03 9.97 176 570314 16713 79157185
Metastases to meninges 11.02 9.97 6 570484 3595 79170303
Nephrotic syndrome 10.91 9.97 42 570448 11132 79162766
Hepatitis E virus test positive 10.90 9.97 12 570478 285 79173613
Bradykinesia 10.89 9.97 26 570464 8017 79165881
Iodine allergy 10.88 9.97 17 570473 574 79173324
Diplopia 10.87 9.97 171 570319 33295 79140603
Ileus paralytic 10.85 9.97 34 570456 9586 79164312
Hand fracture 10.82 9.97 79 570411 6146 79167752
Wrong product administered 10.77 9.97 31 570459 8981 79164917
Benign ovarian tumour 10.77 9.97 13 570477 342 79173556
Osteonecrosis 10.75 9.97 157 570333 30938 79142960
Personality change 10.74 9.97 37 570453 10133 79163765
Mycobacterium tuberculosis complex test positive 10.72 9.97 44 570446 2748 79171150
Muscle spasticity 10.70 9.97 100 570390 21375 79152523
Atrial flutter 10.64 9.97 101 570389 21524 79152374
Hypoglycaemic coma 10.62 9.97 11 570479 4749 79169149
Hypogammaglobulinaemia 10.62 9.97 52 570438 12899 79160999
Candida infection 10.57 9.97 201 570289 38013 79135885
Delivery 10.54 9.97 19 570471 723 79173175
Aspartate aminotransferase increased 10.53 9.97 851 569639 137790 79036108
Hypomania 10.52 9.97 24 570466 7520 79166378
Steroid diabetes 10.50 9.97 6 570484 3500 79170398
Systemic candida 10.48 9.97 20 570470 6686 79167212
Diabetes mellitus 10.48 9.97 456 570034 77934 79095964
Respiratory tract infection viral 10.46 9.97 59 570431 4200 79169698
Laryngeal oedema 10.44 9.97 27 570463 8102 79165796
Keratopathy 10.39 9.97 25 570465 1169 79172729
Hepatic necrosis 10.38 9.97 32 570458 9068 79164830
Kidney transplant rejection 10.34 9.97 38 570452 10208 79163690
CD4 lymphocytes decreased 10.33 9.97 3 570487 2631 79171267
Vein disorder 10.33 9.97 68 570422 5114 79168784
Deep vein thrombosis 10.32 9.97 735 569755 120184 79053714
Upper respiratory tract irritation 10.31 9.97 11 570479 252 79173646
Tooth fracture 10.30 9.97 127 570363 11403 79162495
Hepatitis C 10.29 9.97 47 570443 11878 79162020
Adverse drug reaction 10.26 9.97 577 569913 65815 79108083
Skin neoplasm excision 10.25 9.97 23 570467 1027 79172871
Bone density increased 10.24 9.97 20 570470 809 79173089
Hepatitis fulminant 10.21 9.97 23 570467 7239 79166659
Foetal death 10.17 9.97 95 570395 7949 79165949
Skin ulcer haemorrhage 10.16 9.97 16 570474 544 79173354
Device occlusion 10.10 9.97 47 570443 11819 79162079
Vacuum extractor delivery 10.09 9.97 8 570482 123 79173775
Arthritis bacterial 10.01 9.97 105 570385 9061 79164837
Pancreatic steatosis 9.99 9.97 24 570466 1121 79172777

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A11HA02 ALIMENTARY TRACT AND METABOLISM
VITAMINS
OTHER PLAIN VITAMIN PREPARATIONS
Other plain vitamin preparations
ATC J04AM08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIMYCOBACTERIALS
DRUGS FOR TREATMENT OF TUBERCULOSIS
Combinations of drugs for treatment of tuberculosis
FDA Chemical/Ingredient N0000005657 Vitamin B 6
FDA Chemical/Ingredient N0000175452 Analogs/Derivatives
MeSH PA D018977 Micronutrients
MeSH PA D014803 Vitamin B Complex
MeSH PA D014815 Vitamins
FDA EPC N0000192800 Vitamin B6 Analog
CHEBI has role CHEBI:23357 cofactor
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:75772 S. cerevisiae metabolites
CHEBI has role CHEBI:76971 Escherichia coli metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite

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

DiseaseRelationSNOMED_IDDOID
Pregnancy, function indication 289908002
Vitamin B6 deficiency indication 386080007 DOID:8455
Breastfeeding (mother) indication 413712001
Drug-Induced Pyridoxine Deficiency indication
Pyridoxine-Dependent Seizure indication
Nutritional disorder contraindication 2492009 DOID:374
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Hyperkalemia contraindication 14140009
Gastroenteritis contraindication 25374005 DOID:2326
Dehydration contraindication 34095006
Depressive disorder contraindication 35489007
Acute hepatitis contraindication 37871000
Hemosiderosis contraindication 39011001 DOID:12119
Hypokalemia contraindication 43339004
Chronic heart failure contraindication 48447003
Gastrectomy contraindication 53442002
Systemic lupus erythematosus contraindication 55464009 DOID:9074
Schizophrenia contraindication 58214004 DOID:5419
Acute nephropathy contraindication 58574008
Leber's optic atrophy contraindication 58610003 DOID:705
Metabolic acidosis contraindication 59455009
Hepatic failure contraindication 59927004
Hemolytic anemia contraindication 61261009 DOID:583
Diarrhea contraindication 62315008
Ulcerative colitis contraindication 64766004 DOID:8577
Poisoning by acetaminophen contraindication 70273001
Diabetes mellitus contraindication 73211009 DOID:9351
Gastrointestinal hemorrhage contraindication 74474003
Atrophic gastritis contraindication 84568007 DOID:8929
Autoimmune disease contraindication 85828009
Gout contraindication 90560007 DOID:13189
Kidney disease contraindication 90708001 DOID:557
Anemia due to enzyme deficiency contraindication 111577008
Gastrointestinal obstruction contraindication 126765001
Acute hepatic failure contraindication 197270009
Impaired renal function disorder contraindication 197663003
Gastroparesis contraindication 235675006
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Esophageal dysmotility contraindication 266434009 DOID:9192
Diabetic - poor control contraindication 268519009
Peripheral nerve disease contraindication 302226006
Primary adrenocortical insufficiency contraindication 373662000
Diverticular disease contraindication 397881000
Hemochromatosis contraindication 399187006 DOID:2352
Ketoacidosis in diabetes mellitus contraindication 420422005 DOID:1837
Diabetic peripheral neuropathy contraindication 424736006
Slow acetylator due to N-acetyltransferase enzyme variant contraindication 425079005
Chronic Hepatic Disease contraindication
Genitourinary Tract Infections contraindication
Repeated Blood Transfusions contraindication
Prolonged-Severe Nausea and Vomiting contraindication
Esophageal Compression contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.98 acidic
pKa2 13.8 acidic
pKa3 4.94 Basic

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Serine hydroxymethyltransferase, cytosolic Enzyme WOMBAT-PK
Pyridoxine-5'-phosphate oxidase Enzyme WOMBAT-PK
Pyridoxal phosphate phosphatase Enzyme WOMBAT-PK
Pyridoxal kinase Kinase WOMBAT-PK
Cystathionine beta-synthase Enzyme WOMBAT-PK
Phosphoserine aminotransferase Enzyme WOMBAT-PK

External reference:

IDSource
4019922 VUID
N0000148007 NUI
D02179 KEGG_DRUG
58-56-0 SECONDARY_CAS_RN
4017489 VANDF
4017779 VANDF
4018569 VANDF
4019922 VANDF
4021899 VANDF
C0034272 UMLSCUI
CHEBI:16709 CHEBI
UEG PDB_CHEM_ID
CHEMBL1364 ChEMBL_ID
DB00165 DRUGBANK_ID
CHEMBL1200756 ChEMBL_ID
D011736 MESH_DESCRIPTOR_UI
1054 PUBCHEM_CID
2216 INN_ID
KV2JZ1BI6Z UNII
203164 RXNORM
35074 MMSL
4979 MMSL
4994 MMSL
5393 MMSL
5686 MMSL
6601 MMSL
d00412 MMSL
001058 NDDF
004538 NDDF
126227009 SNOMEDCT_US
430469009 SNOMEDCT_US
767286000 SNOMEDCT_US
D025101 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
NataFort HUMAN PRESCRIPTION DRUG LABEL 10 0178-0716 TABLET 10 mg ORAL Unapproved drug other 12 sections
CitraNatal Harmony 3.0 HUMAN PRESCRIPTION DRUG LABEL 8 0178-0796 CAPSULE, GELATIN COATED 25 mg ORAL unapproved drug other 10 sections
CitraNatal Harmony 3.0 HUMAN PRESCRIPTION DRUG LABEL 8 0178-0796 CAPSULE, GELATIN COATED 25 mg ORAL unapproved drug other 10 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0798 CAPSULE, GELATIN COATED 25 mg ORAL UNAPPROVED DRUG OTHER 11 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0799 CAPSULE, GELATIN COATED 25 mg ORAL Unapproved drug other 11 sections
CitraNatal Harmony HUMAN PRESCRIPTION DRUG LABEL 8 0178-0812 CAPSULE, GELATIN COATED 25 mg ORAL Unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 20 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN PRESCRIPTION DRUG LABEL 16 0178-0821 TABLET 20 mg ORAL unapproved drug other 11 sections
CitraNatal 90 DHA HUMAN OTC DRUG LABEL 14 0178-0829 TABLET 20 mg ORAL Unapproved drug other 11 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 13 0178-0858 TABLET 20 mg ORAL Unapproved drug other 12 sections
CitraNatal Rx HUMAN PRESCRIPTION DRUG LABEL 14 0178-0859 TABLET 20 mg ORAL Unapproved drug other 9 sections
CitraNatal Medley HUMAN PRESCRIPTION DRUG LABEL 8 0178-0896 CAPSULE, GELATIN COATED 12.50 mg ORAL unapproved drug other 10 sections
CitraNatal Medley HUMAN PRESCRIPTION DRUG LABEL 8 0178-0896 CAPSULE, GELATIN COATED 12.50 mg ORAL unapproved drug other 10 sections
CitraNatal DHA HUMAN OTC DRUG LABEL 14 0178-0898 TABLET 20 mg ORAL Unapproved drug other 11 sections
Doxylamine Succinate and Pyridoxine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-4615 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 26 sections
Doxylamine Succinate and Pyridoxine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0378-4615 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 26 sections
Doxylamine succinate and pyridoxine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0591-2132 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 25 sections
Doxylamine succinate and pyridoxine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 0591-2132 TABLET, DELAYED RELEASE 10 mg ORAL ANDA 25 sections
VitafolOne HUMAN PRESCRIPTION DRUG LABEL 16 0642-0070 CAPSULE, GELATIN COATED 2.50 mg ORAL unapproved drug other 14 sections
Vitafol Caplet HUMAN PRESCRIPTION DRUG LABEL 12 0642-0072 CAPSULE 15 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0077 TABLET, CHEWABLE 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 2.50 mg ORAL Unapproved drug other 14 sections
Vitafol OB Caplet HUMAN PRESCRIPTION DRUG LABEL 15 0642-0079 TABLET 2.50 mg ORAL Unapproved drug other 14 sections
Vitafol Plus HUMAN PRESCRIPTION DRUG LABEL 17 0642-0092 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Ultra HUMAN PRESCRIPTION DRUG LABEL 17 0642-0093 CAPSULE, LIQUID FILLED 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Vitafol Nano HUMAN PRESCRIPTION DRUG LABEL 7 0642-0094 TABLET, COATED 2.50 mg ORAL UNAPPROVED DRUG OTHER 14 sections
Select OB HUMAN PRESCRIPTION DRUG LABEL 15 0642-0120 TABLET, CHEWABLE 2.50 mg ORAL UNAPPROVED DRUG OTHER 13 sections
Strovite Forte Caplet HUMAN PRESCRIPTION DRUG LABEL 19 0642-0204 TABLET, COATED 25 mg ORAL UNAPPROVED DRUG OTHER 15 sections