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

Stem definitionDrug idCAS RN
2646 51-48-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • levothyroxine sodium anhydrous
  • levothyroxine sodium pentahydrate
  • L-Thyroxine
  • thyroxin sodium
  • thyroxine sodium
  • levothyroxine sodium
  • tetraiodothyronine
  • thyroxine
  • levothyroxine
  • levothyroxin natrium
  • T4
  • levothyroxine sodium hydrate
The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.
  • Molecular weight: 776.87
  • Formula: C15H11I4NO4
  • CLOGP: 3.21
  • LIPINSKI: 1
  • HAC: 5
  • HDO: 3
  • TPSA: 92.78
  • ALOGS: -4.94
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.15 mg O
0.15 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2000 FDA STEVENS J
Jan. 23, 2020 PMDA Aska Pharmaceutical Co., Ltd

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 1598.60 10.75 130 720992 183596 62584304
Systemic lupus erythematosus 1283.24 10.75 389 720733 208529 62559371
Glossodynia 1227.06 10.75 266 720856 178610 62589290
Contraindicated product administered 1120.86 10.75 535 720587 217113 62550787
Drug ineffective 1081.45 10.75 7206 713916 1037559 61730341
Hand deformity 1028.91 10.75 270 720852 159187 62608713
Blood thyroid stimulating hormone increased 930.94 10.75 721 720401 6473 62761427
Synovitis 926.80 10.75 483 720639 186435 62581465
Anti-cyclic citrullinated peptide antibody positive 903.69 10.75 124 720998 116088 62651812
Treatment failure 885.54 10.75 586 720536 198457 62569443
Infusion related reaction 793.46 10.75 973 720149 244548 62523352
Drug intolerance 792.89 10.75 1434 719688 307227 62460673
Arthropathy 764.49 10.75 925 720197 233867 62534033
Pericarditis 758.42 10.75 273 720849 131306 62636594
Wound 735.12 10.75 474 720648 162789 62605111
Maternal exposure during pregnancy 651.77 10.75 930 720192 219132 62548768
Hypothyroidism 648.40 10.75 1471 719651 41161 62726739
Duodenal ulcer perforation 593.01 10.75 132 720990 87077 62680823
Rheumatoid factor positive 581.57 10.75 124 720998 84282 62683618
Therapeutic product effect decreased 576.38 10.75 812 720310 192375 62575525
Swelling 544.48 10.75 1477 719645 273901 62493999
Abdominal discomfort 533.67 10.75 1863 719259 319022 62448878
Discomfort 533.38 10.75 670 720452 166704 62601196
Helicobacter infection 520.34 10.75 201 720921 92584 62675316
Hepatic enzyme increased 508.38 10.75 952 720170 201376 62566524
Joint swelling 455.35 10.75 2043 719079 325623 62442277
Off label use 437.04 10.75 5234 715888 669228 62098672
Folliculitis 434.80 10.75 129 720993 70188 62697712
Muscle injury 420.57 10.75 111 721011 65234 62702666
Alopecia 412.11 10.75 2203 718919 335333 62432567
Drug hypersensitivity 410.40 10.75 1973 719149 308714 62459186
Lower respiratory tract infection 397.56 10.75 553 720569 131754 62636146
Hypersensitivity 375.93 10.75 1877 719245 290808 62477092
Blood thyroid stimulating hormone abnormal 367.02 10.75 186 720936 698 62767202
Hyperthyroidism 352.18 10.75 613 720509 14060 62753840
Product use issue 349.24 10.75 1306 719816 219214 62548686
Fall 326.82 10.75 6262 714860 386072 62381828
Sleep disorder due to general medical condition, insomnia type 308.20 10.75 104 721018 52113 62715787
Blood thyroid stimulating hormone decreased 300.20 10.75 313 720809 4277 62763623
Irritable bowel syndrome 287.08 10.75 307 720815 82105 62685795
Exposure during pregnancy 270.48 10.75 885 720237 154662 62613238
Rheumatoid arthritis 240.19 10.75 1791 719331 252028 62515872
Thyroid function test abnormal 237.27 10.75 248 720874 3399 62764501
Impaired healing 233.01 10.75 511 720611 102031 62665869
Blister 230.95 10.75 731 720391 129083 62638817
Product substitution issue 229.99 10.75 540 720582 15456 62752444
Palpitations 219.57 10.75 2100 719022 110670 62657230
Infection 217.31 10.75 1616 719506 227557 62540343
Asthenia 210.23 10.75 5774 715348 377830 62390070
Blood thyroid stimulating hormone normal 209.31 10.75 71 721051 52 62767848
Hyponatraemia 192.86 10.75 2032 719090 109868 62658032
Completed suicide 190.31 10.75 928 720194 144745 62623155
Rheumatic fever 190.02 10.75 128 720994 42983 62724917
Pain 186.53 10.75 6713 714409 733915 62033985
Ill-defined disorder 180.35 10.75 414 720708 81341 62686559
Toxicity to various agents 178.91 10.75 1869 719253 245381 62522519
Musculoskeletal stiffness 174.40 10.75 1303 719819 183315 62584585
Rash 172.82 10.75 4951 716171 555920 62211980
Gastrointestinal disorder 168.57 10.75 841 720281 130398 62637502
Myalgia 167.57 10.75 2464 718658 144065 62623835
Swollen joint count increased 167.19 10.75 101 721021 35953 62731947
Dizziness 164.18 10.75 6198 714924 423727 62344173
Stomatitis 161.49 10.75 919 720203 137806 62630094
Feeling abnormal 158.72 10.75 2467 718655 145925 62621975
Thyroid disorder 152.58 10.75 448 720674 14714 62753186
Atrial fibrillation 150.56 10.75 2004 719118 114632 62653268
Product use in unapproved indication 145.81 10.75 1315 719807 177765 62590135
Constipation 137.79 10.75 3437 717685 221506 62546394
Balance disorder 136.60 10.75 1514 719608 82908 62684992
Drug abuse 134.88 10.75 400 720722 72118 62695782
Muscle spasms 130.80 10.75 2496 718626 153654 62614246
Drug tolerance decreased 128.09 10.75 22 721100 17451 62750449
Product prescribing error 125.14 10.75 611 720511 25678 62742222
Liver injury 122.06 10.75 321 720801 60199 62707701
Hip arthroplasty 121.43 10.75 222 720900 47424 62720476
Febrile neutropenia 119.07 10.75 821 720301 117628 62650272
Vertigo 116.88 10.75 1116 720006 58771 62709129
Orthostatic hypotension 116.07 10.75 756 720366 35404 62732496
Intentional product use issue 112.61 10.75 920 720202 126972 62640928
Syncope 111.89 10.75 1915 719207 115470 62652430
Therapy non-responder 107.09 10.75 470 720652 75431 62692469
Drug resistance 106.67 10.75 64 721058 22869 62745031
Psoriatic arthropathy 106.09 10.75 607 720515 90913 62676987
Myelosuppression 104.96 10.75 70 721052 23633 62744267
Cognitive disorder 104.44 10.75 1031 720091 54784 62713116
C-reactive protein abnormal 103.61 10.75 231 720891 45865 62722035
Disturbance in attention 102.89 10.75 765 720357 37424 62730476
Dysgeusia 96.94 10.75 882 720240 45828 62722072
Blood calcium decreased 96.16 10.75 571 720551 25880 62742020
Intentional overdose 94.13 10.75 477 720645 73675 62694225
Cytomegalovirus infection 92.61 10.75 62 721060 20890 62747010
Nasopharyngitis 91.87 10.75 2192 718930 252065 62515835
Sensitisation 91.27 10.75 149 720973 3237 62764663
Red blood cell sedimentation rate abnormal 90.90 10.75 56 721066 19726 62748174
Vision blurred 90.27 10.75 1507 719615 90417 62677483
Sedation complication 90.04 10.75 353 720769 13469 62754431
Condition aggravated 89.50 10.75 3697 717425 398520 62369380
Tremor 89.22 10.75 2048 719074 130191 62637709
Dysphagia 86.89 10.75 1452 719670 87133 62680767
Knee arthroplasty 86.33 10.75 320 720802 53886 62714014
Dehydration 85.46 10.75 2576 718546 170778 62597122
Creatinine renal clearance decreased 84.15 10.75 388 720734 15920 62751980
Transient ischaemic attack 83.56 10.75 723 720399 37030 62730870
Schizoaffective disorder 83.12 10.75 147 720975 3415 62764485
Transplant rejection 80.30 10.75 13 721109 10767 62757133
Product complaint 77.74 10.75 320 720802 12489 62755411
Therapeutic product effect incomplete 76.08 10.75 982 720140 124074 62643826
Adrenocortical insufficiency acute 74.18 10.75 94 721028 1604 62766296
Hepatic function abnormal 74.13 10.75 198 720924 36944 62730956
Autoimmune thyroiditis 73.77 10.75 149 720973 3837 62764063
Adverse event 73.57 10.75 457 720665 67102 62700798
Product formulation issue 72.76 10.75 57 721065 521 62767379
Dry skin 71.94 10.75 974 720148 55913 62711987
Product quality issue 71.78 10.75 672 720450 35193 62732707
Pyrexia 70.24 10.75 4504 716618 465974 62301926
Panniculitis 70.15 10.75 21 721101 11364 62756536
Therapeutic response unexpected 68.86 10.75 406 720716 18353 62749547
Nausea 68.09 10.75 10869 710253 843602 61924298
Hyperhidrosis 67.51 10.75 1653 719469 106183 62661717
Blood pressure increased 67.13 10.75 2359 718763 159703 62608197
Anxiety 66.99 10.75 3067 718055 214474 62553426
Oedema peripheral 66.88 10.75 2710 718412 186801 62581099
Diarrhoea 65.96 10.75 9176 711946 706190 62061710
Thyroid cancer 65.51 10.75 175 720947 5436 62762464
Disease progression 65.06 10.75 991 720131 121767 62646133
Full blood count abnormal 64.34 10.75 596 720526 31121 62736779
Blood glucose increased 64.09 10.75 1321 719801 82435 62685465
Muscular weakness 61.85 10.75 1824 719298 120529 62647371
Hypoglycaemia 61.66 10.75 992 720130 59073 62708827
Psoriasis 61.54 10.75 1356 719766 85601 62682299
Blood parathyroid hormone decreased 60.44 10.75 18 721104 9773 62758127
Hot flush 59.48 10.75 863 720259 50296 62717604
Craniopharyngioma 59.12 10.75 31 721091 127 62767773
Hepatotoxicity 58.76 10.75 219 720903 36822 62731078
Weight decreased 58.48 10.75 3768 717354 273030 62494870
Type 2 diabetes mellitus 58.24 10.75 455 720667 63413 62704487
Visual impairment 57.61 10.75 1310 719812 83136 62684764
Rheumatoid nodule 57.41 10.75 66 721056 17089 62750811
Thyroidectomy 57.25 10.75 68 721054 1082 62766818
Sinusitis 56.73 10.75 2054 719068 224599 62543301
Malaise 55.75 10.75 5466 715656 410488 62357412
Bone marrow failure 55.58 10.75 160 720962 29130 62738770
Anti-cyclic citrullinated peptide antibody 55.47 10.75 6 721116 6752 62761148
Peripheral swelling 54.98 10.75 2464 718658 263478 62504422
Nervousness 54.47 10.75 565 720557 30414 62737486
Bone erosion 54.22 10.75 73 721049 17644 62750256
Gastrooesophageal reflux disease 53.98 10.75 1446 719676 94193 62673707
Insulin-like growth factor increased 53.63 10.75 59 721063 860 62767040
C-reactive protein increased 53.14 10.75 756 720366 93951 62673949
Thyroxine increased 52.50 10.75 49 721073 580 62767320
Arrhythmia 52.39 10.75 663 720459 37477 62730423
Retinitis 52.16 10.75 5 721117 6191 62761709
Insomnia 51.96 10.75 2965 718157 212287 62555613
Ejection fraction 51.95 10.75 96 721026 2310 62765590
Polycystic ovaries 51.75 10.75 139 720983 4332 62763568
Therapeutic drug monitoring analysis not performed 51.55 10.75 70 721052 1282 62766618
Myxoedema coma 50.70 10.75 41 721081 394 62767506
Cerebral haematoma 50.42 10.75 122 721000 3561 62764339
Joint destruction 50.19 10.75 6 721116 6246 62761654
Death 49.49 10.75 3622 717500 370759 62397141
Headache 49.37 10.75 8047 713075 625194 62142706
Bone pain 49.37 10.75 884 720238 53757 62714143
Pregnancy 49.02 10.75 233 720889 36603 62731297
Tri-iodothyronine decreased 48.64 10.75 27 721095 127 62767773
Reversible airways obstruction 48.22 10.75 80 721042 1762 62766138
Cardio-respiratory arrest 47.99 10.75 442 720680 59517 62708383
Product monitoring error 47.91 10.75 136 720986 4380 62763520
Device difficult to use 47.59 10.75 45 721077 12751 62755149
Reaction to excipient 47.25 10.75 70 721052 1394 62766506
Systemic infection 47.18 10.75 138 720984 4522 62763378
Thyroxine free increased 46.89 10.75 54 721068 830 62767070
Amnesia 46.30 10.75 888 720234 54697 62713203
Cardiac disorder 46.22 10.75 823 720299 49993 62717907
Therapeutic response decreased 45.67 10.75 462 720660 61063 62706837
Dry mouth 45.60 10.75 1183 719939 76680 62691220
Urinary tract infection 45.15 10.75 3541 717581 261143 62506757
Acute kidney injury 44.93 10.75 3524 717598 259891 62508009
Macular degeneration 44.92 10.75 135 720987 24241 62743659
Angina pectoris 44.84 10.75 531 720591 29547 62738353
Tinnitus 44.63 10.75 609 720513 35019 62732881
Enthesopathy 44.53 10.75 21 721101 8593 62759307
Breast cancer stage III 44.22 10.75 32 721090 10354 62757546
Device expulsion 44.11 10.75 225 720897 34697 62733203
Small for dates baby 43.80 10.75 117 721005 3634 62764266
Red blood cell sedimentation rate 43.40 10.75 3 721119 4851 62763049
Toxic epidermal necrolysis 43.39 10.75 145 720977 25189 62742711
Infective pulmonary exacerbation of cystic fibrosis 43.31 10.75 23 721099 8794 62759106
Sedation 43.28 10.75 650 720472 38159 62729741
Pulmonary malformation 43.18 10.75 32 721090 267 62767633
Carpal tunnel syndrome 43.14 10.75 393 720729 20424 62747476
Live birth 42.33 10.75 149 720973 25481 62742419
Thyroid hormones increased 42.06 10.75 38 721084 430 62767470
Prescribed overdose 42.04 10.75 222 720900 33931 62733969
Product solubility abnormal 41.89 10.75 50 721072 800 62767100
Flatulence 41.77 10.75 589 720533 34113 62733787
Oral pain 41.77 10.75 500 720622 27894 62740006
Neurotoxicity 41.67 10.75 81 721041 16909 62750991
Renal disorder 41.45 10.75 564 720558 32410 62735490
Device adhesion issue 41.11 10.75 5 721117 5136 62762764
Transplant dysfunction 40.83 10.75 4 721118 4868 62763032
Myxoedema 39.69 10.75 21 721101 88 62767812
Dysphonia 39.43 10.75 760 720362 46854 62721046
Respiratory disorder neonatal 39.42 10.75 59 721063 1186 62766714
Anaemia 39.40 10.75 3857 717265 289573 62478327
Abdominal distension 38.67 10.75 1272 719850 85343 62682557
Breast cancer stage I 38.47 10.75 15 721107 6874 62761026
Gastritis 37.87 10.75 615 720507 36688 62731212
Bradycardia 37.36 10.75 1093 720029 72134 62695766
Disorientation 37.33 10.75 643 720479 38809 62729091
Pathogen resistance 37.30 10.75 13 721109 6385 62761515
Disability 37.22 10.75 97 721025 18250 62749650
Gestational diabetes 37.03 10.75 191 720931 8205 62759695
Pituitary tumour recurrent 36.96 10.75 19 721103 74 62767826
Pancreatic neuroendocrine tumour 36.79 10.75 34 721088 397 62767503
Pulmonary embolism 36.72 10.75 1649 719473 115035 62652865
Multiple organ dysfunction syndrome 36.61 10.75 440 720682 56312 62711588
Anaphylactic reaction 36.60 10.75 529 720593 65571 62702329
Cerebrovascular accident 36.53 10.75 1538 719584 106486 62661414
Hypersomnia 36.48 10.75 339 720783 17716 62750184
Eye irritation 36.42 10.75 396 720726 21575 62746325
Foreign body in reproductive tract 36.25 10.75 44 721078 717 62767183
Inflammation 36.16 10.75 687 720435 81586 62686314
Depression 36.04 10.75 2644 718478 193848 62574052
Mucosal inflammation 35.82 10.75 350 720772 46578 62721322
Diffuse alopecia 35.80 10.75 48 721074 868 62767032
Venoocclusive liver disease 35.63 10.75 6 721116 4829 62763071
Haemophagocytic lymphohistiocytosis 35.44 10.75 41 721081 10586 62757314
Lip swelling 35.31 10.75 522 720600 30541 62737359
Gait disturbance 35.16 10.75 2474 718648 180704 62587196
Rhinitis allergic 35.11 10.75 241 720881 11486 62756414
Malabsorption 35.10 10.75 114 721008 3958 62763942
Hypertensive crisis 35.01 10.75 295 720827 14991 62752909
Haematotoxicity 34.84 10.75 33 721089 9343 62758557
Swollen tongue 34.32 10.75 571 720551 34229 62733671
Decreased appetite 34.14 10.75 3303 717819 247749 62520151
Product administration error 34.10 10.75 397 720725 22000 62745900
Anosmia 33.77 10.75 161 720961 6699 62761201
Blood thyroid stimulating hormone 33.66 10.75 11 721111 6 62767894
Ageusia 33.63 10.75 269 720853 13459 62754441
Lupus vulgaris 33.56 10.75 13 721109 5981 62761919
Thyroid hormones decreased 33.07 10.75 31 721091 369 62767531
Multiple-drug resistance 32.84 10.75 9 721113 5161 62762739
Hypoacusis 32.82 10.75 419 720703 23732 62744168
Neutrophil count decreased 32.80 10.75 447 720675 55959 62711941
Jaw disorder 32.75 10.75 134 720988 5215 62762685
Hyperkalaemia 32.16 10.75 825 720297 53378 62714522
Exophthalmos 32.12 10.75 60 721062 1456 62766444
Drug interaction 32.10 10.75 3021 718101 226110 62541790
Sickle cell anaemia with crisis 32.02 10.75 14 721108 5989 62761911
Neutropenia 31.87 10.75 1643 719479 173362 62594538
Blood test abnormal 31.85 10.75 294 720828 15335 62752565
Hip fracture 31.84 10.75 491 720631 28983 62738917
Liver function test abnormal 31.79 10.75 744 720378 47437 62720463
Arthralgia 31.57 10.75 5845 715277 563865 62204035
Dyspnoea exertional 31.56 10.75 903 720219 59399 62708501
Influenza like illness 31.55 10.75 988 720134 65836 62702064
Memory impairment 31.42 10.75 1467 719655 102791 62665109
Thyroxine abnormal 31.40 10.75 9 721113 0 62767900
Haematochezia 31.20 10.75 813 720309 52731 62715169
Papillary thyroid cancer 31.17 10.75 75 721047 2181 62765719
Atrioventricular block 31.02 10.75 170 720952 7477 62760423
Chest pain 30.80 10.75 2851 718271 213108 62554792
Product measured potency issue 30.53 10.75 18 721104 97 62767803
Pain in extremity 30.50 10.75 4253 716869 327233 62440667
Tongue discomfort 30.16 10.75 75 721047 2228 62765672
Deep vein thrombosis 30.14 10.75 1201 719921 82599 62685301
Vital capacity decreased 30.10 10.75 63 721059 1665 62766235
Septic shock 30.01 10.75 554 720568 66075 62701825
Thyrotoxic crisis 29.89 10.75 43 721079 833 62767067
Post transplant lymphoproliferative disorder 29.72 10.75 10 721112 5021 62762879
Nephritic syndrome 29.64 10.75 27 721095 309 62767591
Chest discomfort 29.52 10.75 1530 719592 108439 62659461
Skin haemorrhage 29.37 10.75 206 720916 9888 62758012
Blood glucose decreased 29.11 10.75 365 720757 20587 62747313
Lactose intolerance 29.02 10.75 87 721035 2891 62765009
Low turnover osteopathy 29.00 10.75 109 721013 4076 62763824
Body height decreased 28.93 10.75 205 720917 9873 62758027
Product taste abnormal 28.87 10.75 69 721053 1998 62765902
Soft tissue disorder 28.86 10.75 113 721009 4309 62763591
International normalised ratio increased 28.84 10.75 711 720411 45714 62722186
Bundle branch block left 28.69 10.75 157 720965 6902 62760998
Autoimmune hepatitis 28.58 10.75 180 720942 8330 62759570
Dyspnoea 28.37 10.75 8170 712952 653143 62114757
Product odour abnormal 28.35 10.75 52 721070 1244 62766656
Product physical issue 28.34 10.75 122 721000 4858 62763042
Product colour issue 28.11 10.75 36 721086 621 62767279
Accidental exposure to product 27.99 10.75 189 720933 27216 62740684
Haematoma 27.89 10.75 553 720569 34267 62733633
Post procedural hypothyroidism 27.76 10.75 24 721098 255 62767645
Therapy partial responder 27.74 10.75 49 721073 10609 62757291
Injury 27.37 10.75 628 720494 72619 62695281
Milk-alkali syndrome 27.31 10.75 40 721082 788 62767112
Adenovirus infection 27.30 10.75 4 721118 3567 62764333
Suicide attempt 27.29 10.75 507 720615 60411 62707489
Red blood cell sedimentation rate increased 27.23 10.75 344 720778 43638 62724262
Unintentional medical device removal 27.15 10.75 18 721104 6097 62761803
Papillitis 26.87 10.75 11 721111 21 62767879
Scleral discolouration 26.83 10.75 29 721093 414 62767486
Exposure to toxic agent 26.83 10.75 15 721107 5572 62762328
Pollakiuria 26.67 10.75 456 720666 27481 62740419
Skin necrosis 26.62 10.75 76 721046 13874 62754026
Hyperglycaemia 26.55 10.75 643 720479 41224 62726676
Overdose 26.52 10.75 1053 720069 114025 62653875
Somnolence 26.24 10.75 2364 718758 176321 62591579
Somatic delusion 26.22 10.75 33 721089 559 62767341
Spinal stenosis 26.14 10.75 272 720850 14653 62753247
Diabetes mellitus 26.04 10.75 824 720298 54986 62712914
Dislocation of vertebra 26 10.75 36 721086 8599 62759301
Dementia 25.94 10.75 327 720795 18467 62749433
Ischaemic stroke 25.88 10.75 315 720807 17642 62750258
Product dispensing error 25.83 10.75 203 720919 10102 62757798
Gastrointestinal toxicity 25.67 10.75 30 721092 7711 62760189
Congenital absence of vertebra 25.64 10.75 12 721110 36 62767864
Foot deformity 25.58 10.75 198 720924 27655 62740245
Incorrect dose administered 25.57 10.75 876 720246 59092 62708808
Pneumocystis jirovecii pneumonia 25.54 10.75 102 721020 16812 62751088
Hypotension 25.48 10.75 3501 717621 269103 62498797
Premature labour 25.45 10.75 66 721056 12438 62755462
Feeling cold 25.44 10.75 397 720725 23491 62744409
Ejection fraction abnormal 25.38 10.75 60 721062 1725 62766175
Lung cyst 25.31 10.75 25 721097 319 62767581
Eye swelling 25.28 10.75 397 720725 23521 62744379
Impaired driving ability 25.28 10.75 110 721012 4401 62763499
Diplopia 25.14 10.75 394 720728 23334 62744566
Withdrawal syndrome 25.12 10.75 342 720780 19655 62748245
Tenderness 25.11 10.75 378 720744 22200 62745700
Arteriosclerosis coronary artery 25.02 10.75 172 720950 8201 62759699
Dry eye 24.95 10.75 623 720499 40138 62727762
Trichorrhexis 24.83 10.75 49 721073 1240 62766660
Sleep apnoea syndrome 24.80 10.75 467 720655 28666 62739234
Sleep disorder due to a general medical condition 24.70 10.75 229 720893 11959 62755941
Chronic respiratory disease 24.49 10.75 19 721103 171 62767729
Inner ear disorder 24.39 10.75 32 721090 566 62767334
Gastrointestinal motility disorder 24.38 10.75 119 721003 5000 62762900
Drug ineffective for unapproved indication 24.37 10.75 258 720864 33805 62734095
Incorrect route of product administration 24.36 10.75 197 720925 27255 62740645
Labelled drug-drug interaction medication error 24.33 10.75 246 720876 13153 62754747
Tenosynovitis 24.28 10.75 78 721044 13717 62754183
Insulin-like growth factor decreased 24.12 10.75 26 721096 370 62767530
Choking 23.88 10.75 193 720929 9686 62758214
Pemphigoid 23.84 10.75 154 720968 7190 62760710
Swelling face 23.83 10.75 914 720208 62561 62705339
Poisoning deliberate 23.77 10.75 58 721064 11160 62756740
Extremity contracture 23.74 10.75 48 721074 1237 62766663
Sputum culture positive 23.72 10.75 66 721056 2101 62765799
Blindness 23.64 10.75 362 720760 21337 62746563
Thyroid cancer recurrent 23.51 10.75 11 721111 33 62767867
Thrombosis 23.50 10.75 929 720193 63826 62704074
Hyperlipidaemia 23.48 10.75 332 720790 19239 62748661
Cataract 23.47 10.75 830 720292 56223 62711677
Nasal obstruction 23.33 10.75 57 721065 1674 62766226
Sprue-like enteropathy 23.23 10.75 35 721087 708 62767192
Change of bowel habit 23.22 10.75 66 721056 2127 62765773
Therapeutic product effect increased 23.18 10.75 46 721076 1169 62766731
Gallbladder disorder 23.16 10.75 321 720801 18521 62749379
Speech disorder 23.12 10.75 615 720507 40014 62727886
Hypophysitis 23.11 10.75 59 721063 1782 62766118
Recalled product 23.11 10.75 50 721072 1353 62766547
Burning sensation 23.00 10.75 794 720328 53613 62714287
Substance abuse 22.94 10.75 13 721109 4794 62763106
Thrombotic microangiopathy 22.86 10.75 54 721068 10507 62757393
Cardiotoxicity 22.69 10.75 38 721084 8400 62759500
Respiratory arrest 22.65 10.75 249 720873 32396 62735504
Tooth fracture 22.65 10.75 209 720913 10901 62756999
Glomerular filtration rate decreased 22.62 10.75 243 720879 13198 62754702
Coronary artery occlusion 22.58 10.75 165 720957 8026 62759874
Subarachnoid haemorrhage 22.56 10.75 255 720867 14028 62753872
Blood loss anaemia 22.39 10.75 177 720945 8824 62759076
Head discomfort 22.33 10.75 242 720880 13173 62754727
Pelvic fracture 22.32 10.75 241 720881 13107 62754793
Chromaturia 22.28 10.75 289 720833 16428 62751472
Blood calcium increased 22.25 10.75 182 720940 9168 62758732
Head injury 22.25 10.75 436 720686 26960 62740940
Premature baby 22.19 10.75 141 720981 20594 62747306
Metastatic renal cell carcinoma 22.18 10.75 36 721086 778 62767122
Back pain 22.12 10.75 3371 717751 260774 62507126
Adverse drug reaction 22.10 10.75 713 720409 79001 62688899
Respiratory tract malformation 22.09 10.75 18 721104 175 62767725
Abnormal dreams 22.03 10.75 199 720923 10317 62757583
Thyroxine free decreased 21.99 10.75 33 721089 665 62767235
Acute graft versus host disease in skin 21.95 10.75 6 721116 3446 62764454
Listless 21.94 10.75 77 721045 2783 62765117
Eye pain 21.79 10.75 521 720601 33333 62734567
Pruritus genital 21.71 10.75 73 721049 2581 62765319
Drug use disorder 21.69 10.75 15 721107 4969 62762931
Cardiac failure congestive 21.65 10.75 1270 719852 91163 62676737
Foetal death 21.56 10.75 59 721063 10921 62756979
Coma 21.54 10.75 561 720561 63803 62704097
Degenerative bone disease 21.47 10.75 17 721105 158 62767742
Abortion spontaneous 21.38 10.75 392 720730 46803 62721097
Urinary incontinence 21.31 10.75 495 720627 31519 62736381
Female genital tract fistula 21.31 10.75 33 721089 7526 62760374
Micturition urgency 21.23 10.75 184 720938 9427 62758473
Intervertebral disc protrusion 21.21 10.75 383 720739 23326 62744574
Disseminated intravascular coagulation 21.19 10.75 128 720994 18923 62748977
Cytokine release syndrome 21.19 10.75 87 721035 14227 62753673
Product dose omission issue 21.13 10.75 3003 718119 231310 62536590
Breast cancer stage II 21.12 10.75 42 721080 8694 62759206
Thyrotoxic periodic paralysis 21.10 10.75 9 721113 20 62767880
Pituitary tumour benign 21.09 10.75 60 721062 1935 62765965
Cardiac arrest 21.06 10.75 848 720274 91697 62676203
Ventricular hypertrophy 20.98 10.75 86 721036 3350 62764550
Haemorrhoids 20.95 10.75 361 720761 21789 62746111
Maternal exposure timing unspecified 20.89 10.75 30 721092 7057 62760843
Body temperature increased 20.81 10.75 297 720825 36895 62731005
Rhabdomyolysis 20.79 10.75 650 720472 43301 62724599
Ankylosing spondylitis 20.77 10.75 56 721066 10418 62757482
Oral discomfort 20.77 10.75 177 720945 9024 62758876
Diverticulum 20.75 10.75 218 720904 11773 62756127
Congenital renal cyst 20.71 10.75 7 721115 5 62767895
Nephrectomy 20.69 10.75 50 721072 1458 62766442
Arterial occlusive disease 20.62 10.75 127 720995 5831 62762069
Therapeutic product effect variable 20.62 10.75 44 721078 1179 62766721
Goitre 20.59 10.75 127 720995 5834 62762066
Muscle fatigue 20.51 10.75 70 721052 2494 62765406
Cardiac pacemaker insertion 20.43 10.75 97 721025 4029 62763871
Blood sodium decreased 20.38 10.75 388 720734 23864 62744036
Ecchymosis 20.29 10.75 204 720918 10890 62757010
Pancreatitis acute 20.29 10.75 427 720695 26739 62741161
Bundle branch block right 20.20 10.75 111 721011 4887 62763013
Hypopituitarism 20.17 10.75 42 721080 1106 62766794
Presbyacusis 20.16 10.75 4 721118 2861 62765039
Polymyalgia rheumatica 20.16 10.75 91 721031 3700 62764200
Paradoxical drug reaction 20.15 10.75 11 721111 4141 62763759
Rib deformity 20.02 10.75 20 721102 259 62767641
Mouth injury 20.01 10.75 39 721083 978 62766922
Lymphadenectomy 20.01 10.75 39 721083 978 62766922
Cytomegalovirus infection reactivation 19.97 10.75 10 721112 3953 62763947
Electrocardiogram ST-T segment abnormal 19.97 10.75 21 721101 290 62767610
Seronegative arthritis 19.94 10.75 10 721112 3949 62763951
Anxiety disorder 19.90 10.75 95 721027 3955 62763945
Paroxysmal extreme pain disorder 19.83 10.75 13 721109 87 62767813
Blood insulin increased 19.78 10.75 15 721107 130 62767770
Broncholithiasis 19.76 10.75 19 721103 234 62767666
Cytomegalovirus viraemia 19.71 10.75 21 721101 5628 62762272
Fatigue 19.66 10.75 10718 710404 877310 61890590
Neutropenic sepsis 19.59 10.75 108 721014 16330 62751570
Subdural hygroma 19.51 10.75 19 721103 238 62767662
Mitral valve incompetence 19.50 10.75 322 720800 19272 62748628
Eating disorder 19.48 10.75 314 720808 18702 62749198
Faeces discoloured 19.48 10.75 307 720815 18202 62749698
Carotid artery occlusion 19.48 10.75 105 721017 4589 62763311
Abortion induced 19.39 10.75 56 721066 10186 62757714
Injection site reaction 19.35 10.75 511 720611 58013 62709887
Lethargy 19.28 10.75 799 720323 55208 62712692
Pneumonia viral 19.28 10.75 155 720967 7767 62760133
Atrial septal defect 19.26 10.75 140 720982 6798 62761102
Tooth dislocation 19.23 10.75 9 721113 27 62767873
Blood creatine abnormal 19.16 10.75 14 721108 114 62767786
Aortic valve incompetence 19.09 10.75 125 720997 5863 62762037
Jaundice 19.08 10.75 451 720671 28800 62739100
Temperature regulation disorder 19.04 10.75 25 721097 6107 62761793
Tri-iodothyronine increased 18.98 10.75 15 721107 139 62767761
Palmoplantar keratoderma 18.96 10.75 58 721064 1949 62765951
Blood triglycerides increased 18.85 10.75 221 720901 12267 62755633
Hiatus hernia 18.67 10.75 347 720775 21247 62746653
Thinking abnormal 18.65 10.75 194 720928 10449 62757451
Graft versus host disease in skin 18.56 10.75 5 721117 2900 62765000
Stillbirth 18.52 10.75 30 721092 6720 62761180
Cystitis haemorrhagic 18.49 10.75 12 721110 4111 62763789
Facet joint syndrome 18.45 10.75 73 721049 12065 62755835
Throat clearing 18.45 10.75 65 721057 2354 62765546
Vitamin D deficiency 18.45 10.75 240 720882 13652 62754248
Chronic sinusitis 18.43 10.75 79 721043 12764 62755136
Feeling jittery 18.41 10.75 233 720889 13170 62754730
Genital swelling 18.40 10.75 14 721108 122 62767778
Renal dysplasia 18.20 10.75 18 721104 230 62767670
Muscle spasticity 18.16 10.75 159 720963 21635 62746265
Spondylolisthesis 18.15 10.75 84 721038 3452 62764448
Multiple allergies 18.14 10.75 238 720884 13564 62754336
International normalised ratio abnormal 18.09 10.75 80 721042 3224 62764676
Hypertension 18.05 10.75 3516 717606 275787 62492113
Lactic acidosis 18.05 10.75 566 720556 37721 62730179
Thyroxine decreased 17.96 10.75 29 721093 624 62767276
Supraventricular extrasystoles 17.94 10.75 101 721021 4488 62763412
Drug eruption 17.92 10.75 224 720898 28470 62739430
Drug level changed 17.90 10.75 17 721105 206 62767694
Product residue present 17.89 10.75 91 721031 3888 62764012
Skin ulcer 17.83 10.75 363 720759 42682 62725218
Blood iron abnormal 17.77 10.75 11 721111 3865 62764035
Hypocalcaemia 17.74 10.75 479 720643 31234 62736666
Epstein-Barr virus infection 17.55 10.75 41 721081 8009 62759891
Multiple drug therapy 17.54 10.75 85 721037 3561 62764339
Rheumatoid lung 17.53 10.75 11 721111 3837 62764063
Hallucination 17.52 10.75 776 720346 54041 62713859
Posterior reversible encephalopathy syndrome 17.52 10.75 120 721002 17225 62750675
Neonatal thyrotoxicosis 17.45 10.75 5 721117 0 62767900
Eyelid oedema 17.43 10.75 189 720933 10290 62757610
Blood growth hormone increased 17.41 10.75 24 721098 446 62767454
Dilatation atrial 17.39 10.75 56 721066 1935 62765965
Gingival pain 17.38 10.75 155 720967 8007 62759893
Application site erythema 17.33 10.75 104 721018 4731 62763169
Arrhythmia neonatal 17.33 10.75 9 721113 36 62767864
Femur fracture 17.31 10.75 608 720514 41148 62726752
Respiratory disorder 17.27 10.75 326 720796 38756 62729144
Neuromyopathy 17.12 10.75 29 721093 650 62767250
Bladder disorder 17.09 10.75 166 720956 8780 62759120
Adjustment disorder with depressed mood 17.07 10.75 59 721063 10145 62757755
Dysuria 17.04 10.75 503 720619 33235 62734665
Musculoskeletal disorder 17.03 10.75 151 720971 20493 62747407
Atrial tachycardia 17.03 10.75 94 721028 4146 62763754
Aspergillus infection 17.03 10.75 42 721080 8051 62759849
Hair texture abnormal 16.99 10.75 94 721028 4149 62763751
Cardiospasm 16.99 10.75 54 721068 1853 62766047
Oesophagitis 16.98 10.75 252 720870 14756 62753144
Peripheral coldness 16.93 10.75 212 720910 11953 62755947
Rectal polyp 16.92 10.75 41 721081 1198 62766702
Dysstasia 16.90 10.75 336 720786 20830 62747070
Anaemia postoperative 16.89 10.75 60 721062 2182 62765718
Visual field defect 16.86 10.75 130 720992 6431 62761469
Confusional arousal 16.84 10.75 16 721106 194 62767706
Persistent depressive disorder 16.82 10.75 37 721085 1013 62766887
Exposure via ingestion 16.81 10.75 6 721116 2903 62764997
Glycosylated haemoglobin increased 16.80 10.75 215 720907 12183 62755717
Graft versus host disease 16.80 10.75 32 721090 6731 62761169
Labile hypertension 16.79 10.75 24 721098 462 62767438
Vessel puncture site haemorrhage 16.76 10.75 13 721109 117 62767783
Skin exfoliation 16.74 10.75 623 720499 42479 62725421
Pulse abnormal 16.74 10.75 62 721060 2302 62765598
Diabetes mellitus inadequate control 16.73 10.75 253 720869 14873 62753027
Aphasia 16.67 10.75 492 720630 32508 62735392
Pulmonary tuberculosis 16.66 10.75 16 721106 4501 62763399
Erythema dyschromicum perstans 16.66 10.75 10 721112 56 62767844
Hormone level abnormal 16.65 10.75 64 721058 2419 62765481
Intentional self-injury 16.62 10.75 199 720923 25488 62742412
Starvation ketoacidosis 16.61 10.75 11 721111 75 62767825
Graft versus host disease in gastrointestinal tract 16.60 10.75 8 721114 3233 62764667
Product packaging issue 16.56 10.75 40 721082 1166 62766734
Oropharyngeal swelling 16.54 10.75 34 721088 887 62767013
Depressed level of consciousness 16.51 10.75 863 720259 61215 62706685
Bronchopulmonary aspergillosis 16.51 10.75 47 721075 8588 62759312
Blood cholesterol increased 16.50 10.75 886 720236 93146 62674754
Product tampering 16.48 10.75 22 721100 396 62767504
Dystonia 16.36 10.75 91 721031 13728 62754172
Sleep terror 16.30 10.75 67 721055 2613 62765287
Full blood count decreased 16.29 10.75 399 720723 25625 62742275
Thyroid atrophy 16.28 10.75 7 721115 16 62767884
Visual acuity reduced 16.28 10.75 343 720779 21483 62746417
Gastrointestinal tract irritation 16.23 10.75 24 721098 477 62767423
Aplastic anaemia 16.23 10.75 55 721067 9514 62758386
Injection site mass 16.21 10.75 300 720822 18356 62749544
Joint laxity 16.21 10.75 4 721118 2460 62765440
Anosognosia 16.20 10.75 8 721114 3188 62764712
Diabetic ketoacidosis 16.20 10.75 325 720797 20180 62747720
Loss of consciousness 16.16 10.75 1555 719567 116566 62651334
Lymphoproliferative disorder 16.15 10.75 8 721114 3182 62764718
Disturbance in social behaviour 16.11 10.75 13 721109 3980 62763920
Traumatic ulcer 16.11 10.75 9 721113 43 62767857
Drug dependence 16.10 10.75 189 720933 24294 62743606
Inappropriate antidiuretic hormone secretion 16.10 10.75 256 720866 15206 62752694
Urine odour abnormal 16.09 10.75 126 720996 6263 62761637
Proctitis 16.07 10.75 23 721099 5418 62762482
Tension 15.98 10.75 75 721047 3100 62764800
Thyroglobulin increased 15.95 10.75 9 721113 44 62767856
Atrioventricular block first degree 15.94 10.75 139 720983 7134 62760766
Gingival disorder 15.92 10.75 81 721041 3461 62764439
Cerebellar haematoma 15.90 10.75 21 721101 374 62767526
Body height increased 15.86 10.75 10 721112 62 62767838
Abdominal pain upper 15.82 10.75 2622 718500 203822 62564078
Eye disorder 15.80 10.75 353 720769 22332 62745568
Eye pruritus 15.79 10.75 299 720823 18372 62749528
Hyperchromic anaemia 15.79 10.75 9 721113 45 62767855
No adverse event 15.74 10.75 354 720768 41051 62726849
Hepatitis B reactivation 15.68 10.75 8 721114 3129 62764771
Labyrinthitis 15.63 10.75 61 721061 2322 62765578
Rash papular 15.61 10.75 258 720864 15444 62752456
Groin pain 15.59 10.75 181 720941 10022 62757878
Petechiae 15.59 10.75 233 720889 13664 62754236
Tonsillar disorder 15.58 10.75 38 721084 1115 62766785
Abnormal weight gain 15.56 10.75 51 721071 1779 62766121
Lymph node calcification 15.50 10.75 19 721103 313 62767587
Body height below normal 15.46 10.75 3 721119 2180 62765720
Magnetic resonance imaging thoracic abnormal 15.46 10.75 7 721115 19 62767881
Device use error 15.44 10.75 26 721096 5735 62762165
Skin abrasion 15.39 10.75 168 720954 9161 62758739
Restlessness 15.39 10.75 441 720681 29012 62738888
Renal failure 15.39 10.75 1544 719578 116108 62651792
Chronic graft versus host disease 15.37 10.75 8 721114 3094 62764806
Coombs positive haemolytic anaemia 15.36 10.75 20 721102 351 62767549
Retinal artery embolism 15.36 10.75 10 721112 66 62767834
Oesophageal achalasia 15.34 10.75 23 721099 463 62767437
Claustrophobia 15.33 10.75 35 721087 983 62766917
Gastrointestinal haemorrhage 15.32 10.75 1095 720027 80081 62687819
Frontotemporal dementia 15.28 10.75 20 721102 353 62767547
Prescribed underdose 15.26 10.75 241 720881 29448 62738452
Product coating issue 15.24 10.75 10 721112 67 62767833
Fear of injection 15.21 10.75 37 721085 7127 62760773
Increased tendency to bruise 15.16 10.75 185 720937 10367 62757533
Arteriosclerosis 15.13 10.75 178 720944 9888 62758012
Sensation of foreign body 15.10 10.75 99 721023 4646 62763254
Hepatocellular carcinoma 15.08 10.75 57 721065 2137 62765763
Nephropathy toxic 15.06 10.75 56 721066 9423 62758477
Endocrine disorder 15.06 10.75 28 721094 677 62767223
Temperature intolerance 15.06 10.75 162 720960 8802 62759098
Scar 15.04 10.75 230 720892 13552 62754348
Rectourethral fistula 15.03 10.75 8 721114 34 62767866
Malignant melanoma 15.00 10.75 196 720926 11160 62756740
Hyperadrenalism 14.96 10.75 7 721115 21 62767879
COVID-19 14.90 10.75 1485 719637 111618 62656282
Retrograde amnesia 14.85 10.75 23 721099 477 62767423
Bone formation increased 14.85 10.75 14 721108 168 62767732
Piloerection 14.78 10.75 20 721102 365 62767535
Poor quality product administered 14.77 10.75 73 721049 3083 62764817
Carotid artery stenosis 14.74 10.75 105 721017 5065 62762835
Poisoning 14.74 10.75 93 721029 13607 62754293
Pituitary tumour 14.73 10.75 33 721089 915 62766985
Blood pressure inadequately controlled 14.72 10.75 102 721020 4876 62763024
Therapeutic response changed 14.72 10.75 35 721087 1010 62766890
Coordination abnormal 14.71 10.75 229 720893 13544 62754356
Adenoiditis 14.68 10.75 8 721114 36 62767864
Breast discomfort 14.68 10.75 23 721099 482 62767418
Postural tremor 14.66 10.75 19 721103 332 62767568
Eructation 14.66 10.75 152 720970 8181 62759719
Orthostatic intolerance 14.65 10.75 38 721084 1159 62766741
Immunodeficiency 14.65 10.75 153 720969 20101 62747799
Dysarthria 14.63 10.75 609 720513 42102 62725798
Tension headache 14.60 10.75 105 721017 5081 62762819
Lupus nephritis 14.55 10.75 7 721115 2832 62765068
Premature delivery 14.52 10.75 249 720873 30032 62737868
Anti-thyroid antibody positive 14.51 10.75 21 721101 409 62767491
Presyncope 14.51 10.75 416 720706 27369 62740531
Juvenile idiopathic arthritis 14.49 10.75 10 721112 3316 62764584
Joint range of motion decreased 14.49 10.75 270 720852 32158 62735742
Intramedullary rod insertion 14.47 10.75 55 721067 2068 62765832
Pleural fibrosis 14.39 10.75 11 721111 3461 62764439
Acute myocardial infarction 14.39 10.75 472 720650 31652 62736248
Increased appetite 14.35 10.75 170 720952 9460 62758440
Open reduction of fracture 14.34 10.75 37 721085 1125 62766775
Hemiparesis 14.29 10.75 356 720766 22926 62744974
Transcription medication error 14.27 10.75 15 721107 207 62767693
Tri-iodothyronine free decreased 14.25 10.75 18 721104 306 62767594
Ventilation perfusion mismatch 14.24 10.75 23 721099 495 62767405
Dental caries 14.22 10.75 186 720936 10593 62757307
Mood altered 14.20 10.75 241 720881 14502 62753398
Sepsis 14.20 10.75 1522 719600 151601 62616299
Thyroid cancer metastatic 14.19 10.75 13 721109 150 62767750
Amniotic fluid volume increased 14.19 10.75 13 721109 150 62767750
Lipoma 14.18 10.75 60 721062 2371 62765529
Oesophageal disorder 14.18 10.75 59 721063 2314 62765586
Rapid eye movement sleep behaviour disorder 14.17 10.75 18 721104 308 62767592
Cerebral haemorrhage 14.15 10.75 453 720669 30276 62737624
BK virus infection 14.10 10.75 10 721112 3269 62764631
Wrong patient received product 14.08 10.75 56 721066 2151 62765749
Dactylitis 14.08 10.75 6 721116 2606 62765294
Vocal cord paresis 14.07 10.75 12 721110 125 62767775
Ophthalmic vein thrombosis 14.05 10.75 15 721107 211 62767689
Hyponatraemic seizure 14.04 10.75 21 721101 422 62767478
Hypotensive transfusion reaction 14.03 10.75 8 721114 40 62767860
Bradykinesia 14.01 10.75 104 721018 5084 62762816
Varicose vein 13.99 10.75 101 721021 4894 62763006
Hair growth abnormal 13.98 10.75 69 721053 2912 62764988
Optic nerve compression 13.96 10.75 4 721118 0 62767900
Gout 13.92 10.75 220 720902 13051 62754849
Carcinoid tumour of the stomach 13.92 10.75 13 721109 154 62767746
Pharyngitis 13.83 10.75 154 720968 19989 62747911
Insulin autoimmune syndrome 13.83 10.75 11 721111 103 62767797
Limb deformity 13.83 10.75 15 721107 3987 62763913
Upper-airway cough syndrome 13.82 10.75 194 720928 11224 62756676
Mean cell haemoglobin concentration increased 13.82 10.75 23 721099 508 62767392
Upper limb fracture 13.80 10.75 297 720825 18671 62749229
Wrist fracture 13.79 10.75 224 720898 13363 62754537
Gastric pH increased 13.73 10.75 8 721114 42 62767858
Sodium retention 13.70 10.75 12 721110 130 62767770
Urine sodium decreased 13.66 10.75 13 721109 158 62767742
Hypogammaglobulinaemia 13.64 10.75 39 721083 7116 62760784
Nocturia 13.62 10.75 147 720975 7994 62759906
Retching 13.60 10.75 238 720884 14407 62753493
Intervertebral disc disorder 13.60 10.75 98 721024 4745 62763155
Anal prolapse 13.53 10.75 10 721112 83 62767817
Hypercholesterolaemia 13.53 10.75 166 720956 21168 62746732
Endocrine ophthalmopathy 13.53 10.75 26 721096 645 62767255
Decreased bronchial secretion 13.52 10.75 9 721113 62 62767838
Rotator cuff repair 13.50 10.75 54 721068 2080 62765820
Neurologic neglect syndrome 13.50 10.75 64 721058 2657 62765243
X-ray abnormal 13.49 10.75 47 721075 8063 62759837
Anaemia vitamin B12 deficiency 13.47 10.75 20 721102 399 62767501
Psychomotor skills impaired 13.47 10.75 58 721064 2310 62765590
Acute hepatic failure 13.44 10.75 138 720984 18189 62749711
Facial pain 13.42 10.75 181 720941 10380 62757520
Lumbar radiculopathy 13.41 10.75 51 721071 1918 62765982
Mucormycosis 13.37 10.75 8 721114 2863 62765037
Deafness transitory 13.35 10.75 3 721119 1967 62765933
Coronary artery disease 13.31 10.75 471 720651 31906 62735994
Sexual dysfunction 13.30 10.75 18 721104 4341 62763559
Granulocytopenia 13.28 10.75 110 721012 5562 62762338
Adenomatous polyposis coli 13.25 10.75 10 721112 86 62767814
Joint stiffness 13.21 10.75 368 720754 41501 62726399
Poor sucking reflex 13.20 10.75 17 721105 295 62767605
Basedow's disease 13.20 10.75 17 721105 295 62767605
Vitello-intestinal duct remnant 13.16 10.75 8 721114 46 62767854
Hypoglycaemic unconsciousness 13.15 10.75 28 721094 749 62767151
Acute respiratory distress syndrome 13.14 10.75 188 720934 23346 62744554
Reaction to colouring 13.11 10.75 7 721115 30 62767870
Aortic intramural haematoma 13.07 10.75 10 721112 88 62767812
Hepatojugular reflux 13.07 10.75 6 721116 17 62767883
Impatience 13.06 10.75 19 721103 372 62767528
Hypoglycaemia neonatal 13.03 10.75 32 721090 943 62766957
Abdominal pain lower 13.01 10.75 383 720739 25295 62742605
Irritability 13.01 10.75 461 720661 31233 62736667
Pulmonary arterial hypertension 12.91 10.75 342 720780 22235 62745665
Neck injury 12.88 10.75 53 721069 2068 62765832
Cough 12.86 10.75 3621 717501 289122 62478778
Mobility decreased 12.79 10.75 1193 719929 119966 62647934
Haemoglobin decreased 12.79 10.75 1862 719260 143623 62624277
Metastases to bone 12.79 10.75 165 720957 20854 62747046
Parathyroid gland enlargement 12.76 10.75 7 721115 32 62767868
Pancreatic neoplasm 12.76 10.75 27 721095 719 62767181
Congenital acrochordon 12.76 10.75 8 721114 49 62767851
Mental status changes 12.75 10.75 561 720561 39038 62728862
Paraesthesia 12.75 10.75 2000 719122 154966 62612934
Recalled product administered 12.68 10.75 22 721100 503 62767397
Vaccination site reaction 12.64 10.75 11 721111 118 62767782
Spinal osteoarthritis 12.61 10.75 256 720866 15930 62751970
Large intestine polyp 12.60 10.75 145 720977 8012 62759888
Thyroxine free abnormal 12.59 10.75 6 721116 19 62767881
Arteriovenous malformation 12.57 10.75 39 721083 1321 62766579
Drug withdrawal syndrome 12.55 10.75 401 720721 26793 62741107
Lip blister 12.55 10.75 58 721064 2382 62765518
Plasma cell myeloma 12.54 10.75 513 720609 35392 62732508
Immune reconstitution inflammatory syndrome 12.47 10.75 32 721090 6052 62761848
Expired product administered 12.46 10.75 116 721006 6065 62761835
Blood creatine phosphokinase decreased 12.44 10.75 22 721100 511 62767389
Ingrowing nail 12.44 10.75 58 721064 2391 62765509
Mitral valve sclerosis 12.42 10.75 11 721111 121 62767779
Limb discomfort 12.39 10.75 433 720689 29283 62738617
Alanine aminotransferase abnormal 12.38 10.75 20 721102 4484 62763416
Renal cancer metastatic 12.32 10.75 16 721106 280 62767620
Agitation neonatal 12.32 10.75 22 721100 515 62767385
Intervertebral disc degeneration 12.31 10.75 249 720873 15483 62752417
Subdural haematoma 12.31 10.75 230 720892 14098 62753802
Unintended pregnancy 12.28 10.75 33 721089 6146 62761754
Myositis 12.27 10.75 160 720962 9106 62758794
Electrocardiogram change 12.24 10.75 25 721097 649 62767251
Atrial flutter 12.22 10.75 167 720955 9605 62758295
Inappropriate affect 12.22 10.75 30 721092 884 62767016
Autoimmune dermatitis 12.21 10.75 11 721111 124 62767776
Abnormal uterine bleeding 12.19 10.75 42 721080 1504 62766396
Pulmonary valve incompetence 12.17 10.75 39 721083 1344 62766556
Breast cancer female 12.17 10.75 97 721025 13462 62754438
Retinal dystrophy 12.15 10.75 6 721116 21 62767879
Foetal chromosome abnormality 12.15 10.75 6 721116 21 62767879
Oedema mouth 12.15 10.75 57 721065 2356 62765544
Apathy 12.13 10.75 153 720969 8641 62759259
Tooth discolouration 12.13 10.75 31 721091 937 62766963
Lupus-like syndrome 12.13 10.75 113 721009 15182 62752718
Anaemia folate deficiency 12.12 10.75 14 721108 216 62767684
Pneumonia aspiration 12.11 10.75 299 720823 34241 62733659
Intestinal haemorrhage 12.08 10.75 80 721042 3767 62764133
Barrett's oesophagus 12.07 10.75 24 721098 611 62767289
Peripheral vascular disorder 12.03 10.75 113 721009 5922 62761978
Urinary retention 12.01 10.75 439 720683 29862 62738038
Internal haemorrhage 12.00 10.75 100 721022 5065 62762835
Ventricular extrasystoles 11.98 10.75 193 720929 11494 62756406
Tricuspid valve incompetence 11.97 10.75 233 720889 14388 62753512
Lymph node palpable 11.97 10.75 10 721112 101 62767799
Neovascular age-related macular degeneration 11.97 10.75 14 721108 219 62767681
Congenital hydronephrosis 11.96 10.75 19 721103 403 62767497
Cholelithiasis 11.96 10.75 612 720510 43313 62724587
Idiosyncratic drug reaction 11.95 10.75 28 721094 800 62767100
Chronic lymphocytic leukaemia 11.90 10.75 60 721062 2554 62765346
Drug reaction with eosinophilia and systemic symptoms 11.83 10.75 293 720829 33543 62734357
Trance 11.83 10.75 7 721115 38 62767862
Follicular thyroid cancer 11.80 10.75 8 721114 57 62767843
Viral mutation identified 11.79 10.75 3 721119 1807 62766093
Metastases to liver 11.78 10.75 193 720929 23446 62744454
Drug specific antibody 11.78 10.75 6 721116 2349 62765551
Energy increased 11.78 10.75 62 721060 2685 62765215
Immunisation 11.76 10.75 35 721087 1158 62766742
Physical abuse 11.75 10.75 4 721118 3 62767897
Liver function test normal 11.75 10.75 4 721118 3 62767897
Cardiac valve sclerosis 11.74 10.75 6 721116 23 62767877
Kidney malrotation 11.74 10.75 6 721116 23 62767877
Acute hepatitis B 11.72 10.75 17 721105 332 62767568
Injection site swelling 11.68 10.75 432 720690 47140 62720760
Muscle contractions involuntary 11.67 10.75 56 721066 2336 62765564
Joint dislocation 11.65 10.75 147 720975 18653 62749247
Needle issue 11.65 10.75 174 720948 10202 62757698
Cold sweat 11.63 10.75 197 720925 11850 62756050
Electrocardiogram ST segment abnormal 11.62 10.75 31 721091 962 62766938
Sinus bradycardia 11.62 10.75 231 720891 14320 62753580
Blood pressure orthostatic decreased 11.60 10.75 9 721113 81 62767819
Skin dystrophy 11.58 10.75 8 721114 59 62767841
Muscle twitching 11.56 10.75 299 720823 19369 62748531
Pure white cell aplasia 11.55 10.75 7 721115 40 62767860
Vein discolouration 11.54 10.75 14 721108 228 62767672
Electrocardiogram abnormal 11.53 10.75 157 720965 9022 62758878
Mastication disorder 11.53 10.75 51 721071 2055 62765845
Weight loss poor 11.51 10.75 35 721087 1172 62766728
Supraventricular tachyarrhythmia 11.51 10.75 9 721113 82 62767818
Polyp 11.49 10.75 119 721003 6402 62761498
Bruxism 11.49 10.75 74 721048 3451 62764449
Bronchial secretion retention 11.49 10.75 62 721060 2711 62765189
Complications of transplanted kidney 11.47 10.75 7 721115 2479 62765421
Parathyroid tumour benign 11.46 10.75 26 721096 727 62767173
Procedural pain 11.46 10.75 174 720948 21395 62746505
Electrolyte imbalance 11.45 10.75 304 720818 19772 62748128
Lung lobectomy 11.44 10.75 10 721112 108 62767792
Fracture nonunion 11.40 10.75 54 721068 2241 62765659
Emotional distress 11.35 10.75 465 720657 32084 62735816
Haemorrhagic stroke 11.33 10.75 108 721014 5684 62762216
Histamine intolerance 11.28 10.75 7 721115 42 62767858
Meniere's disease 11.28 10.75 13 721109 200 62767700
Renal cyst 11.27 10.75 172 720950 10130 62757770
Myopathy toxic 11.26 10.75 21 721101 509 62767391
Electrocardiogram QT prolonged 11.23 10.75 803 720319 58727 62709173
Chronic fatigue syndrome 11.22 10.75 33 721089 1085 62766815
Aortic valve disease 11.21 10.75 34 721088 1137 62766763
Vascular access complication 11.20 10.75 5 721117 2113 62765787
Low density lipoprotein increased 11.20 10.75 116 721006 6241 62761659
Pre-existing condition improved 11.19 10.75 143 720979 8101 62759799
Onychoclasis 11.18 10.75 114 721008 6108 62761792
Tooth disorder 11.18 10.75 408 720714 27749 62740151
Application site swelling 11.17 10.75 22 721100 556 62767344
Gastric cancer 11.17 10.75 23 721099 4700 62763200
Periorbital inflammation 11.16 10.75 8 721114 63 62767837
Rectal haemorrhage 11.16 10.75 672 720450 48358 62719542
Growth hormone deficiency 11.16 10.75 11 721111 140 62767760
Skin burning sensation 11.14 10.75 205 720917 12529 62755371
Tuberculosis 11.11 10.75 78 721044 11133 62756767
Immune effector cell-associated neurotoxicity syndrome 11.10 10.75 6 721116 2271 62765629
Tooth abscess 11.09 10.75 235 720887 14734 62753166
Acetabulum fracture 11.08 10.75 16 721106 311 62767589
Pernicious anaemia 11.08 10.75 24 721098 650 62767250
Oesophageal obstruction 11.06 10.75 22 721100 560 62767340
Nightmare 11.05 10.75 291 720831 18903 62748997
Status epilepticus 11.05 10.75 115 721007 15118 62752782
Pulmonary fibrosis 11.05 10.75 356 720766 39453 62728447
Panic attack 11.03 10.75 332 720790 21999 62745901
Anal incontinence 11.00 10.75 216 720906 13360 62754540
Hypoparathyroidism 10.98 10.75 24 721098 654 62767246
Stasis dermatitis 10.95 10.75 25 721097 702 62767198
Wheelchair user 10.93 10.75 36 721086 6283 62761617
Enamel anomaly 10.93 10.75 5 721117 14 62767886
Pleural neoplasm 10.93 10.75 17 721105 354 62767546
Colon operation 10.89 10.75 17 721105 355 62767545
Emotional disorder 10.89 10.75 213 720909 13166 62754734
Overgrowth bacterial 10.87 10.75 10 721112 116 62767784
Angle closure glaucoma 10.87 10.75 52 721070 2167 62765733
Ulcer 10.86 10.75 220 720902 25887 62742013
Adulterated product 10.83 10.75 14 721108 244 62767656
Melanoma recurrent 10.80 10.75 11 721111 146 62767754
Narrow anterior chamber angle 10.78 10.75 7 721115 46 62767854
Medulloblastoma recurrent 10.77 10.75 8 721114 67 62767833
Deformity 10.76 10.75 83 721039 11601 62756299

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
Hypothyroidism 373.04 10.23 522 196621 20380 34739408
Blood thyroid stimulating hormone increased 291.55 10.23 220 196923 4035 34755753
Drug abuse 285.61 10.23 101 197042 98995 34660793
Drug ineffective 247.49 10.23 1538 195605 455213 34304575
Foetal exposure during pregnancy 213.13 10.23 582 196561 37519 34722269
Toxicity to various agents 210.46 10.23 516 196627 199846 34559942
Off label use 175.68 10.23 1519 195624 418005 34341783
Atrial septal defect 169.69 10.23 209 196934 7183 34752605
Craniopharyngioma 127.99 10.23 52 197091 247 34759541
Febrile neutropenia 125.79 10.23 376 196767 136473 34623315
Fatigue 112.43 10.23 2808 194335 367845 34391943
Small for dates baby 106.64 10.23 121 197022 3806 34755982
Blood thyroid stimulating hormone decreased 104.30 10.23 87 197056 1854 34757934
Treatment failure 90.53 10.23 78 197065 46619 34713169
Thyroid disorder 81.28 10.23 95 197048 3087 34756701
Asthenia 79.55 10.23 1876 195267 243375 34516413
Pituitary tumour benign 77.44 10.23 53 197090 828 34758960
Thyroid function test abnormal 76.91 10.23 49 197094 674 34759114
Blood thyroid stimulating hormone abnormal 72.48 10.23 38 197105 352 34759436
Drug resistance 71.97 10.23 28 197115 25899 34733889
Cardiospasm 70.83 10.23 64 197079 1524 34758264
Palmoplantar keratoderma 68.63 10.23 69 197074 1884 34757904
Drug dependence 65.84 10.23 27 197116 24190 34735598
Neutropenia 65.51 10.23 567 196576 156211 34603577
Anosmia 63.73 10.23 95 197048 3929 34755859
Tension headache 63.45 10.23 82 197061 2960 34756828
Respiratory disorder neonatal 61.76 10.23 60 197083 1570 34758218
Atrial tachycardia 60.54 10.23 88 197055 3557 34756231
Product use in unapproved indication 59.40 10.23 403 196740 117096 34642692
Insulin-like growth factor decreased 57.68 10.23 29 197114 244 34759544
Large for dates baby 57.49 10.23 45 197098 873 34758915
Pruritus genital 56.63 10.23 66 197077 2138 34757650
Sleep terror 55.57 10.23 67 197076 2251 34757537
Thyroxine free decreased 54.29 10.23 29 197114 280 34759508
Thyroid cancer 52.98 10.23 56 197087 1624 34758164
Infantile apnoea 51.48 10.23 43 197100 918 34758870
Dizziness 51.21 10.23 1603 195540 216918 34542870
Insulin-like growth factor increased 49.45 10.23 47 197096 1196 34758592
Dehydration 48.27 10.23 1014 196129 128955 34630833
Adrenocortical insufficiency acute 48.10 10.23 52 197091 1548 34758240
Chronic pigmented purpura 47.61 10.23 20 197123 105 34759683
Patent ductus arteriosus 47.24 10.23 75 197068 3279 34756509
Immunisation 47.24 10.23 43 197100 1034 34758754
Hyperthyroidism 47.17 10.23 149 196994 10417 34749371
Hypopituitarism 46.79 10.23 61 197082 2221 34757567
Carotid artery occlusion 46.47 10.23 79 197064 3658 34756130
Neurotoxicity 44.42 10.23 23 197120 17987 34741801
Pituitary tumour recurrent 44.05 10.23 18 197125 87 34759701
Decreased appetite 43.10 10.23 1236 195907 165156 34594632
Bradycardia neonatal 42.87 10.23 39 197104 937 34758851
Autoimmune thyroiditis 42.22 10.23 42 197101 1132 34758656
Drug ineffective for unapproved indication 41.97 10.23 43 197100 23672 34736116
Facial pain 41.77 10.23 75 197068 3629 34756159
Multiple organ dysfunction syndrome 41.01 10.23 258 196885 76308 34683480
Sepsis 40.47 10.23 678 196465 165883 34593905
Ventricular septal defect 40.09 10.23 77 197066 3924 34755864
Cytomegalovirus infection 39.19 10.23 54 197089 26081 34733707
Adrenal insufficiency 39.05 10.23 170 196973 13877 34745911
Bone marrow failure 38.54 10.23 66 197077 29187 34730601
Suicide attempt 38.43 10.23 104 197039 39012 34720776
Fall 37.89 10.23 1450 195693 201435 34558353
Goitre 37.80 10.23 47 197096 1631 34758157
Diarrhoea 37.53 10.23 2615 194528 387297 34372491
Dry skin 37.32 10.23 303 196840 30984 34728804
Pyloric stenosis 36.59 10.23 34 197109 840 34758948
Toxic epidermal necrolysis 35.28 10.23 42 197101 21604 34738184
Thyroxine decreased 34.17 10.23 19 197124 200 34759588
Drug hypersensitivity 34.14 10.23 290 196853 80239 34679549
Urethral atresia 34.06 10.23 11 197132 22 34759766
Pain of skin 33.81 10.23 93 197050 6016 34753772
Epiphysiolysis 33.80 10.23 15 197128 92 34759696
Tropical infectious disease 33.77 10.23 12 197131 36 34759752
Hypophysitis 33.42 10.23 52 197091 2234 34757554
Vesicoureteric reflux 33.33 10.23 18 197125 178 34759610
Therapeutic product effect incomplete 33.26 10.23 159 196984 50382 34709406
Immune reconstitution inflammatory syndrome 32.95 10.23 5 197138 8754 34751034
Poisoning 32.64 10.23 14 197129 12212 34747576
Haematotoxicity 32.43 10.23 4 197139 8190 34751598
Therapy non-responder 32.12 10.23 113 197030 39033 34720755
Overdose 31.78 10.23 344 196799 90715 34669073
Graft versus host disease 31.76 10.23 10 197133 10559 34749229
Palmar-plantar erythrodysaesthesia syndrome 31.60 10.23 182 196961 16613 34743175
Bronchopulmonary aspergillosis 31.56 10.23 22 197121 14637 34745151
Thyroid hormones decreased 31.49 10.23 16 197127 138 34759650
Secondary hypogonadism 30.97 10.23 20 197123 282 34759506
Infusion related reaction 30.93 10.23 174 196969 52883 34706905
Myelosuppression 30.74 10.23 38 197105 19227 34740561
Palpitations 30.74 10.23 353 196790 39633 34720155
Transient ischaemic attack 30.58 10.23 263 196880 27350 34732438
Foetal megacystis 30.48 10.23 11 197132 35 34759753
Pneumocystis jirovecii pneumonia 30.29 10.23 40 197103 19670 34740118
Pathogen resistance 30.28 10.23 8 197135 9474 34750314
Pericarditis 30.16 10.23 138 197005 11507 34748281
Hypospadias 30.12 10.23 60 197083 3141 34756647
Blood testosterone decreased 28.91 10.23 71 197072 4286 34755502
Muscle twitching 28.91 10.23 125 197018 10173 34749615
Blood glucose increased 28.59 10.23 532 196611 66186 34693602
Thyroxine free increased 27.92 10.23 18 197125 253 34759535
Potassium wasting nephropathy 27.75 10.23 13 197130 92 34759696
Diplopia 27.55 10.23 176 196967 16667 34743121
Neonatal behavioural syndrome 27.24 10.23 14 197129 124 34759664
Drug intolerance 26.85 10.23 211 196932 59359 34700429
Growth hormone deficiency 26.58 10.23 18 197125 276 34759512
Dysphonia 26.57 10.23 224 196919 23159 34736629
Cytomegalovirus viraemia 26.28 10.23 5 197138 7425 34752363
Diabetic foetopathy 26.22 10.23 16 197127 203 34759585
Product use issue 26.19 10.23 229 196914 62987 34696801
Muscular weakness 26.14 10.23 566 196577 72331 34687457
Papillary thyroid cancer 26.05 10.23 25 197118 644 34759144
Macrocephaly 25.71 10.23 22 197121 486 34759302
C-reactive protein increased 25.62 10.23 189 196954 53909 34705879
Diabetes insipidus 25.32 10.23 53 197090 2875 34756913
Substance abuse 25.27 10.23 6 197137 7635 34752153
Blood thyroid stimulating hormone normal 25.10 10.23 6 197137 0 34759788
Leukopenia 25.03 10.23 230 196913 62626 34697162
Premature baby 24.98 10.23 193 196950 19440 34740348
Septic shock 24.80 10.23 272 196871 71562 34688226
Neoplasm recurrence 24.67 10.23 45 197098 2204 34757584
Flatulence 24.58 10.23 204 196939 20994 34738794
Myxoedema coma 24.44 10.23 17 197126 273 34759515
Neutropenic sepsis 24.32 10.23 25 197118 13742 34746046
Aspergillus infection 24.32 10.23 20 197123 12234 34747554
General physical health deterioration 24.20 10.23 918 196225 127351 34632437
Pulmonary valve stenosis congenital 24.03 10.23 13 197130 129 34759659
Respiratory depression 23.92 10.23 34 197109 16211 34743577
Appendicitis 23.84 10.23 29 197114 14778 34745010
Walking aid user 23.04 10.23 40 197103 1884 34757904
Tumour lysis syndrome 22.92 10.23 38 197105 17021 34742767
Electrocardiogram QRS complex abnormal 22.79 10.23 18 197125 354 34759434
Contraindicated product administered 22.73 10.23 55 197088 21426 34738362
Selective eating disorder 22.66 10.23 38 197105 1740 34758048
Eye pruritus 22.65 10.23 93 197050 7396 34752392
Alanine aminotransferase increased 22.64 10.23 320 196823 80495 34679293
Neutrophil count decreased 22.58 10.23 182 196961 50922 34708866
Newborn persistent pulmonary hypertension 22.54 10.23 12 197131 115 34759673
Metastatic renal cell carcinoma 22.31 10.23 41 197102 2020 34757768
Glossodynia 22.23 10.23 58 197085 3635 34756153
Painful respiration 22.23 10.23 31 197112 1205 34758583
Disturbance in attention 22.21 10.23 234 196909 25711 34734077
Completed suicide 22.08 10.23 405 196738 97763 34662025
Cerebral atrophy congenital 21.68 10.23 10 197133 68 34759720
Epstein-Barr virus infection 21.56 10.23 8 197135 7620 34752168
Thyroid hormones increased 21.56 10.23 10 197133 69 34759719
Transplant rejection 21.51 10.23 16 197127 10295 34749493
Thyroid cancer metastatic 21.31 10.23 9 197134 48 34759740
Sedation 21.28 10.23 55 197088 20951 34738837
Synovitis 21.15 10.23 29 197114 14037 34745751
Intentional self-injury 21.10 10.23 28 197115 13743 34746045
Blood thyroid stimulating hormone 20.92 10.23 5 197138 0 34759788
Congenital mitral valve incompetence 20.75 10.23 12 197131 137 34759651
Drug reaction with eosinophilia and systemic symptoms 20.49 10.23 106 197037 32906 34726882
Lip swelling 20.42 10.23 158 196985 15922 34743866
Cytopenia 20.40 10.23 25 197118 12698 34747090
Anti-thyroid antibody positive 20.31 10.23 9 197134 55 34759733
Weight decreased 20.25 10.23 1201 195942 175100 34584688
Cytokine release syndrome 20.16 10.23 64 197079 22813 34736975
Neonatal respiratory distress syndrome 19.98 10.23 59 197084 3975 34755813
Pituitary tumour 19.75 10.23 20 197123 551 34759237
Hepatic function abnormal 19.59 10.23 158 196985 44205 34715583
Hypoglycaemia neonatal 19.56 10.23 37 197106 1864 34757924
Thyroiditis 19.55 10.23 42 197101 2320 34757468
Haemangioma congenital 19.50 10.23 19 197124 499 34759289
Infective pulmonary exacerbation of cystic fibrosis 19.45 10.23 7 197136 6794 34752994
Granulocytopenia 19.43 10.23 81 197062 6486 34753302
Post procedural hypothyroidism 19.27 10.23 6 197137 10 34759778
Disease progression 19.27 10.23 463 196680 107614 34652174
Fractured coccyx 19.22 10.23 12 197131 159 34759629
Condition aggravated 19.18 10.23 887 196256 191309 34568479
Neonatal tachypnoea 19.09 10.23 12 197131 161 34759627
Intentional overdose 19.08 10.23 156 196987 43518 34716270
Hepatotoxicity 19.01 10.23 60 197083 21425 34738363
Nephropathy toxic 18.88 10.23 26 197117 12562 34747226
C-reactive protein abnormal 18.84 10.23 13 197130 8697 34751091
Anencephaly 18.84 10.23 11 197132 128 34759660
Aortic aneurysm 18.81 10.23 82 197061 6697 34753091
Cerebrovascular accident 18.71 10.23 618 196525 84193 34675595
Dermatomyositis 18.50 10.23 29 197114 1254 34758534
Hypoacusis 18.44 10.23 156 196987 16145 34743643
Blindness 18.34 10.23 146 196997 14840 34744948
Anaphylactic shock 18.34 10.23 39 197104 15902 34743886
Haemophagocytic lymphohistiocytosis 18.27 10.23 28 197115 12945 34746843
Anaphylactic reaction 18.25 10.23 107 197036 32194 34727594
Febrile bone marrow aplasia 18.10 10.23 12 197131 8197 34751591
Migraine 18.07 10.23 164 196979 17314 34742474
Growth retardation 17.82 10.23 35 197108 1813 34757975
Urticaria 17.82 10.23 246 196897 62131 34697657
Alopecia 17.82 10.23 213 196930 24142 34735646
Adenovirus infection 17.64 10.23 4 197139 5253 34754535
Drug interaction 17.60 10.23 1069 196074 224877 34534911
Total lung capacity abnormal 17.47 10.23 11 197132 148 34759640
Infection 17.47 10.23 385 196758 90530 34669258
Pituitary apoplexy 17.39 10.23 8 197135 54 34759734
Acute graft versus host disease in skin 17.36 10.23 4 197139 5197 34754591
Cardiogenic shock 17.36 10.23 84 197059 26534 34733254
Cardiac septal hypertrophy 17.32 10.23 14 197129 285 34759503
Mucormycosis 17.19 10.23 6 197137 5936 34753852
Pseudomonas infection 17.18 10.23 27 197116 12355 34747433
Anaemia of malignant disease 17.12 10.23 17 197126 457 34759331
Coeliac disease 17.11 10.23 21 197122 719 34759069
Subarachnoid haemorrhage 17.08 10.23 126 197017 12509 34747279
Neonatal respiratory acidosis 17.03 10.23 8 197135 57 34759731
Tinnitus 17.01 10.23 181 196962 19937 34739851
Cytomegalovirus infection reactivation 16.96 10.23 4 197139 5114 34754674
Pyrexia 16.89 10.23 1633 195510 331380 34428408
Conduction disorder 16.88 10.23 37 197106 2073 34757715
Thyroid cancer recurrent 16.73 10.23 4 197139 0 34759788
Brain natriuretic peptide abnormal 16.67 10.23 15 197128 355 34759433
Enthesopathy 16.54 10.23 3 197140 4610 34755178
Tri-iodothyronine increased 16.47 10.23 8 197135 62 34759726
Dependence on oxygen therapy 16.42 10.23 12 197131 209 34759579
Amnesia 16.34 10.23 225 196918 26338 34733450
Rhythm idioventricular 16.34 10.23 14 197129 310 34759478
Sopor 16.33 10.23 27 197116 12109 34747679
Forced vital capacity decreased 16.31 10.23 21 197122 755 34759033
BK virus infection 16.25 10.23 6 197137 5732 34754056
Intercapillary glomerulosclerosis 16.18 10.23 7 197136 40 34759748
Lymphocyte count decreased 16.18 10.23 69 197074 22553 34737235
Feeling abnormal 16.13 10.23 469 196674 62766 34697022
Blood growth hormone increased 16.06 10.23 15 197128 373 34759415
Serotonin syndrome 16.04 10.23 58 197085 19875 34739913
Wrong schedule 16.01 10.23 11 197132 173 34759615
Brain oedema 15.74 10.23 34 197109 13787 34746001
Haemorrhoids 15.71 10.23 138 197005 14437 34745351
Therapeutic product effect decreased 15.68 10.23 123 197020 34620 34725168
Cortisol decreased 15.59 10.23 25 197118 1102 34758686
Coagulation disorder neonatal 15.58 10.23 6 197137 24 34759764
Pancytopenia 15.52 10.23 413 196730 94744 34665044
Mucosal inflammation 15.51 10.23 141 197002 38481 34721307
Delirium 15.41 10.23 166 196977 43825 34715963
Hyponatraemia 15.39 10.23 591 196552 82100 34677688
Urine oxalate increased 15.16 10.23 5 197138 11 34759777
Hyperprolactinaemia 15.12 10.23 30 197113 1566 34758222
Interstitial lung disease 15.09 10.23 268 196875 65014 34694774
Neutrophil count increased 15.08 10.23 48 197095 17098 34742690
Atrial fibrillation 15.04 10.23 839 196304 121554 34638234
Chest discomfort 14.89 10.23 217 196926 54313 34705475
N-terminal prohormone brain natriuretic peptide abnormal 14.75 10.23 11 197132 198 34759590
Epispadias 14.68 10.23 10 197133 155 34759633
Alveolitis 14.60 10.23 31 197112 1699 34758089
Thyroxine increased 14.57 10.23 8 197135 82 34759706
Tri-iodothyronine decreased 14.56 10.23 9 197134 117 34759671
Tachyarrhythmia 14.41 10.23 49 197094 3559 34756229
Extrapyramidal disorder 14.41 10.23 32 197111 12848 34746940
Pulmonary arterial pressure abnormal 14.38 10.23 11 197132 206 34759582
Shoulder dystocia 14.36 10.23 6 197137 31 34759757
Vasculitis 14.35 10.23 111 197032 11185 34748603
Oedema peripheral 14.28 10.23 819 196324 118993 34640795
Cardiotoxicity 14.25 10.23 7 197136 5641 34754147
Memory impairment 14.16 10.23 332 196811 42986 34716802
Pulmonary pain 14.08 10.23 25 197118 1199 34758589
Ankylosing spondylitis 14.05 10.23 7 197136 5597 34754191
Ageusia 14.05 10.23 103 197040 10205 34749583
Chest injury 13.99 10.23 29 197114 1562 34758226
Thyroid mass 13.91 10.23 16 197127 511 34759277
Intercepted product preparation error 13.89 10.23 3 197140 4075 34755713
Product substitution issue 13.84 10.23 101 197042 9994 34749794
Cardiac hypertrophy 13.72 10.23 22 197121 970 34758818
Exposure via breast milk 13.60 10.23 33 197110 1977 34757811
Mineral deficiency 13.49 10.23 6 197137 37 34759751
Maternal exposure during breast feeding 13.45 10.23 28 197115 1513 34758275
Colorectal cancer 13.45 10.23 5 197138 4756 34755032
Thyroidectomy 13.43 10.23 7 197136 64 34759724
Foreign body in throat 13.42 10.23 8 197135 97 34759691
Aorticopulmonary septal defect 13.39 10.23 5 197138 18 34759770
Osteochondroma 13.39 10.23 5 197138 18 34759770
Neonatal respiratory distress 13.38 10.23 17 197126 603 34759185
Cardiac failure 13.35 10.23 636 196507 90612 34669176
Medulloblastoma recurrent 13.34 10.23 7 197136 65 34759723
Oxygen saturation increased 13.31 10.23 12 197131 285 34759503
Toxic neuropathy 13.14 10.23 16 197127 543 34759245
Lumbar puncture 13.14 10.23 8 197135 101 34759687
Hypersomnia 13.13 10.23 117 197026 12290 34747498
Anal inflammation 13 10.23 25 197118 1275 34758513
Pulmonary artery stenosis 12.90 10.23 12 197131 297 34759491
Aplastic anaemia 12.72 10.23 22 197121 9694 34750094
Hypertension 12.67 10.23 913 196230 135530 34624258
Tracheal pain 12.63 10.23 6 197137 44 34759744
Intentional product misuse 12.63 10.23 181 196962 45430 34714358
Cardiac arrest 12.56 10.23 430 196713 95729 34664059
Polyglandular autoimmune syndrome type II 12.55 10.23 3 197140 0 34759788
Product prescribing error 12.44 10.23 190 196953 22737 34737051
Radiation inflammation 12.42 10.23 20 197123 885 34758903
Hypotonia neonatal 12.40 10.23 25 197118 1320 34758468
Neonatal pneumothorax 12.39 10.23 4 197139 8 34759780
Therapy partial responder 12.39 10.23 22 197121 9594 34750194
Optic nerve disorder 12.31 10.23 17 197126 655 34759133
Lymphadenopathy 12.28 10.23 102 197041 28361 34731427
Hypernatraemia 12.25 10.23 86 197057 8404 34751384
Thrombocytopenia 12.19 10.23 739 196404 155508 34604280
Bradycardia 12.19 10.23 531 196612 74887 34684901
Respiratory tract haemorrhage 12.18 10.23 24 197119 1246 34758542
Tongue movement disturbance 12.14 10.23 8 197135 117 34759671
Prescribed underdose 12.03 10.23 89 197054 8844 34750944
Cranial sutures widening 12.02 10.23 7 197136 81 34759707
Constipation 11.95 10.23 912 196231 136070 34623718
Retrograde amnesia 11.91 10.23 8 197135 121 34759667
Haemoglobinaemia 11.79 10.23 9 197134 168 34759620
Thyroid adenoma 11.78 10.23 4 197139 10 34759778
Psychotic disorder 11.78 10.23 85 197058 24367 34735421
Tracheal fistula 11.74 10.23 8 197135 124 34759664
Urethral valves 11.73 10.23 11 197132 275 34759513
Moaning 11.66 10.23 18 197125 768 34759020
Gastrooesophageal cancer 11.64 10.23 5 197138 28 34759760
Liposarcoma 11.63 10.23 8 197135 126 34759662
Seroma 11.61 10.23 16 197127 615 34759173
Thyroxine abnormal 11.51 10.23 4 197139 11 34759777
Neonatal asphyxia 11.49 10.23 12 197131 343 34759445
Respiratory failure 11.44 10.23 498 196645 108074 34651714
Empty sella syndrome 11.41 10.23 6 197137 56 34759732
Joint swelling 11.39 10.23 254 196889 59636 34700152
Oesophageal carcinoma 11.35 10.23 22 197121 9282 34750506
Pneumonia fungal 11.33 10.23 14 197129 7086 34752702
Growth hormone-producing pituitary tumour 11.32 10.23 6 197137 57 34759731
Hypersensitivity 11.28 10.23 260 196883 60775 34699013
Skin indentation 11.26 10.23 4 197139 12 34759776
Primary hypothyroidism 11.23 10.23 6 197137 58 34759730
Congenital hydronephrosis 11.17 10.23 17 197126 716 34759072
Acute myeloid leukaemia 11.15 10.23 59 197084 18211 34741577
Neonatal respiratory failure 11.13 10.23 12 197131 356 34759432
Peripheral swelling 11.09 10.23 533 196610 76008 34683780
Drug level increased 11.04 10.23 76 197067 22020 34737768
Hospice care 11.03 10.23 72 197071 6868 34752920
Tri-iodothyronine free increased 11.02 10.23 4 197139 13 34759775
Lymphopenia 10.97 10.23 51 197092 16284 34743504
Malignant melanoma stage IV 10.96 10.23 5 197138 33 34759755
Suicidal ideation 10.93 10.23 161 196982 40227 34719561
Therapeutic response decreased 10.92 10.23 109 197034 29204 34730584
Agitation neonatal 10.87 10.23 21 197122 1075 34758713
Hair colour changes 10.81 10.23 29 197114 1848 34757940
COVID-19 pneumonia 10.80 10.23 54 197089 16913 34742875
Injection site cyst 10.80 10.23 4 197139 14 34759774
Gangrene neonatal 10.78 10.23 9 197134 192 34759596
Brachydactyly 10.78 10.23 9 197134 192 34759596
Scapula fracture 10.76 10.23 10 197133 247 34759541
Oesophageal motility disorder 10.76 10.23 7 197136 100 34759688
Application site inflammation 10.76 10.23 7 197136 100 34759688
Blood glucose decreased 10.68 10.23 118 197025 13119 34746669
Thrombotic microangiopathy 10.64 10.23 28 197115 10602 34749186
Blood prolactin decreased 10.63 10.23 10 197133 251 34759537
Faecaloma 10.60 10.23 59 197084 5318 34754470
Cervicogenic headache 10.59 10.23 4 197139 15 34759773
Oral discomfort 10.54 10.23 36 197107 2621 34757167
Abdominal discomfort 10.51 10.23 425 196718 59410 34700378
Escherichia infection 10.50 10.23 19 197124 8226 34751562
CNS germinoma 10.49 10.23 3 197140 3 34759785
Follicular thyroid cancer 10.49 10.23 3 197140 3 34759785
Application site erythema 10.48 10.23 33 197110 2303 34757485
Bacterial infection 10.47 10.23 55 197088 17008 34742780
Vitello-intestinal duct remnant 10.45 10.23 8 197135 150 34759638
Bronchiectasis 10.44 10.23 25 197118 9776 34750012
Hyperparathyroidism 10.40 10.23 22 197121 1202 34758586
Rash papular 10.40 10.23 96 197047 10182 34749606
Hypoxia 10.38 10.23 234 196909 54861 34704927
Hand deformity 10.37 10.23 4 197139 3721 34756067
Hyperbilirubinaemia neonatal 10.35 10.23 17 197126 765 34759023

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
Hypothyroidism 801.88 10.24 1604 735631 50788 78956365
Blood thyroid stimulating hormone increased 772.88 10.24 673 736562 9035 78998118
Drug ineffective 748.31 10.24 6404 730831 1074509 77932644
Pemphigus 528.81 10.24 134 737101 99448 78907705
Off label use 494.87 10.24 5689 731546 901526 78105627
Drug abuse 478.85 10.24 478 736757 162213 78844940
Synovitis 457.39 10.24 431 736804 150303 78856850
Toxicity to various agents 454.49 10.24 2177 735058 419363 78587790
Anti-cyclic citrullinated peptide antibody positive 431.70 10.24 117 737118 83026 78924127
Treatment failure 424.03 10.24 573 736662 169913 78837240
Contraindicated product administered 399.42 10.24 522 736713 157016 78850137
Drug intolerance 393.19 10.24 1196 736039 262923 78744230
Systemic lupus erythematosus 383.53 10.24 333 736902 120816 78886337
Infusion related reaction 380.82 10.24 991 736244 229246 78777907
Hand deformity 375.86 10.24 249 736986 103670 78903483
Fall 346.56 10.24 6381 730854 481248 78525905
Glossodynia 344.48 10.24 270 736965 103067 78904086
Febrile neutropenia 341.65 10.24 1049 736186 229950 78777203
Blood thyroid stimulating hormone decreased 284.30 10.24 306 736929 5410 79001743
Duodenal ulcer perforation 270.19 10.24 137 737098 66074 78941079
Hyperthyroidism 261.83 10.24 612 736623 21597 78985556
Therapeutic product effect decreased 256.05 10.24 725 736510 163138 78844015
Rheumatoid factor positive 248.42 10.24 121 737114 59718 78947435
Arthropathy 243.90 10.24 830 736405 176281 78830872
Pericarditis 240.68 10.24 369 736866 103867 78903286
Palpitations 240.25 10.24 1996 735239 124614 78882539
Completed suicide 232.07 10.24 1327 735908 244440 78762713
Blood thyroid stimulating hormone normal 230.80 10.24 73 737162 52 79007101
Helicobacter infection 216.46 10.24 195 737040 69509 78937644
Drug hypersensitivity 207.84 10.24 1765 735470 297151 78710002
Folliculitis 206.64 10.24 128 737107 55252 78951901
Product use in unapproved indication 205.78 10.24 1411 735824 248948 78758205
Drug resistance 203.51 10.24 68 737167 42145 78965008
Asthenia 203.22 10.24 6178 731057 505511 78501642
Wound 202.11 10.24 487 736748 115692 78891461
Hepatic enzyme increased 195.27 10.24 945 736290 181665 78825488
Muscle injury 194.39 10.24 103 737132 48458 78958695
Blood thyroid stimulating hormone abnormal 191.04 10.24 116 737119 844 79006309
Thyroid disorder 189.50 10.24 409 736826 13670 78993483
Thyroid function test abnormal 183.28 10.24 183 737052 2951 79004202
Dizziness 182.99 10.24 6256 730979 520185 78486968
Hypersensitivity 177.55 10.24 1559 735676 260680 78746473
Lower respiratory tract infection 164.95 10.24 625 736610 128595 78878558
Sleep disorder due to general medical condition, insomnia type 160.67 10.24 102 737133 43454 78963699
Hyponatraemia 159.97 10.24 2420 734815 175428 78831725
Joint swelling 159.13 10.24 1803 735432 286843 78720310
Discomfort 157.49 10.24 612 736623 125005 78882148
Cytomegalovirus infection 157.12 10.24 100 737135 42544 78964609
Fatigue 151.10 10.24 10246 726989 919481 78087672
Headache 148.66 10.24 7427 729808 646345 78360808
Product substitution issue 146.15 10.24 466 736769 19790 78987363
Infection 143.56 10.24 1484 735751 240228 78766925
Feeling abnormal 142.29 10.24 2164 735071 157035 78850118
Myelosuppression 141.07 10.24 100 737135 40196 78966957
Multiple organ dysfunction syndrome 138.77 10.24 605 736630 119641 78887512
Balance disorder 135.71 10.24 1455 735780 97402 78909751
Maternal exposure during pregnancy 135.47 10.24 725 736510 135813 78871340
Neutropenia 130.72 10.24 1872 735363 285838 78721315
Cognitive disorder 127.60 10.24 1093 736142 68833 78938320
Craniopharyngioma 125.03 10.24 65 737170 335 79006818
Product use issue 122.21 10.24 1294 735941 208528 78798625
Hepatic function abnormal 121.25 10.24 314 736921 72793 78934360
Muscle spasms 120.35 10.24 2277 734958 172453 78834700
Irritable bowel syndrome 119.60 10.24 247 736988 61994 78945159
Sedation complication 117.20 10.24 365 736870 15304 78991849
Swelling 116.51 10.24 1361 735874 215350 78791803
Vertigo 115.83 10.24 1060 736175 68022 78939131
Transplant rejection 115.80 10.24 20 737215 19417 78987736
Creatinine renal clearance decreased 114.05 10.24 411 736824 18591 78988562
Bone marrow failure 113.14 10.24 186 737049 50921 78956232
Intentional overdose 112.83 10.24 549 736686 105411 78901742
Myalgia 112.10 10.24 2372 734863 183269 78823884
Pyrexia 109.68 10.24 5143 732092 673566 78333587
Product prescribing error 107.72 10.24 747 736488 44066 78963087
Disturbance in attention 107.29 10.24 821 736414 49980 78957173
Therapy non-responder 106.75 10.24 464 736771 91841 78915312
Nausea 105.00 10.24 10238 726997 946958 78060195
Sensitisation 103.46 10.24 140 737095 3171 79003982
Blood calcium decreased 103.26 10.24 573 736662 31246 78975907
Constipation 102.22 10.24 3380 733855 279670 78727483
Orthostatic hypotension 101.48 10.24 876 736359 55288 78951865
Dry skin 96.70 10.24 1008 736227 66987 78940166
Sepsis 95.41 10.24 1835 735400 267593 78739560
Transient ischaemic attack 94.22 10.24 820 736415 51875 78955278
Septic shock 91.22 10.24 712 736523 122089 78885064
Death 89.60 10.24 4302 732933 562212 78444941
Dehydration 88.39 10.24 2959 734276 245228 78761925
Toxic epidermal necrolysis 88.14 10.24 174 737061 44407 78962746
Neurotoxicity 87.33 10.24 103 737132 32415 78974738
Adrenocortical insufficiency acute 86.60 10.24 123 737112 2920 79004233
Diarrhoea 83.16 10.24 9324 727911 871165 78135988
Impaired healing 82.79 10.24 473 736762 87182 78919971
Product quality issue 82.30 10.24 567 736668 33373 78973780
Neutrophil count decreased 81.40 10.24 521 736714 93438 78913715
Acute graft versus host disease 80.67 10.24 3 737232 10164 78996989
Venoocclusive liver disease 79.95 10.24 8 737227 11763 78995390
Overdose 79.27 10.24 1211 736024 182995 78824158
Pathogen resistance 76.69 10.24 19 737216 14323 78992830
Syncope 76.49 10.24 2187 735048 177262 78829891
Disease progression 74.65 10.24 1226 736009 183136 78824017
Drug ineffective for unapproved indication 73.30 10.24 236 736999 51002 78956151
Anosmia 72.72 10.24 213 737022 8631 78998522
Cardiac arrest 72.15 10.24 1137 736098 170959 78836194
Urinary tract infection 71.62 10.24 3163 734072 271349 78735804
Abdominal discomfort 71.32 10.24 1768 735467 248959 78758194
Vision blurred 71.15 10.24 1375 735860 104523 78902630
C-reactive protein abnormal 71.15 10.24 220 737015 48147 78959006
Hepatotoxicity 71.07 10.24 240 736995 51112 78956041
Dysgeusia 70.91 10.24 825 736410 56352 78950801
C-reactive protein increased 70.60 10.24 807 736428 128220 78878933
Stomatitis 70.46 10.24 944 736291 145813 78861340
Autoimmune thyroiditis 70.07 10.24 134 737101 4099 79003054
Post transplant lymphoproliferative disorder 70.07 10.24 11 737224 11453 78995700
Blister 69.04 10.24 738 736497 118738 78888415
Cardio-respiratory arrest 69.04 10.24 655 736580 107855 78899298
Atrial fibrillation 68.83 10.24 2353 734882 195533 78811620
Muscular weakness 68.54 10.24 1959 735276 158770 78848383
Red blood cell sedimentation rate abnormal 68.29 10.24 56 737179 20907 78986246
Cytokine release syndrome 67.36 10.24 145 737090 35853 78971300
Insulin-like growth factor increased 67.09 10.24 85 737150 1801 79005352
Drug dependence 66.91 10.24 176 737059 40593 78966560
Pneumocystis jirovecii pneumonia 66.78 10.24 124 737111 32384 78974769
Haemophagocytic lymphohistiocytosis 66.70 10.24 62 737173 21775 78985378
Myxoedema coma 66.68 10.24 55 737180 682 79006471
Bronchopulmonary aspergillosis 66.11 10.24 65 737170 22229 78984924
Pituitary tumour benign 65.87 10.24 99 737136 2477 79004676
Polycystic ovaries 65.50 10.24 122 737113 3657 79003496
Cardiospasm 65.45 10.24 113 737122 3188 79003965
Gastrointestinal disorder 65.05 10.24 769 736466 121436 78885717
Haematotoxicity 64.98 10.24 31 737204 15488 78991665
Product complaint 64.81 10.24 270 736965 13079 78994074
Thyroid cancer 64.79 10.24 153 737082 5435 79001718
Palmoplantar keratoderma 64.45 10.24 120 737115 3596 79003557
Musculoskeletal stiffness 63.74 10.24 1186 736049 173822 78833331
Cystitis haemorrhagic 62.91 10.24 6 737229 9166 78997987
Ill-defined disorder 62.46 10.24 355 736880 65520 78941633
Hot flush 61.59 10.24 777 736458 54100 78953053
Suicide attempt 61.50 10.24 481 736754 82451 78924702
Ejection fraction 60.60 10.24 89 737146 2180 79004973
Amnesia 60.15 10.24 867 736368 62190 78944963
Carpal tunnel syndrome 59.63 10.24 346 736889 19182 78987971
Thyroxine free increased 59.60 10.24 65 737170 1167 79005986
Panniculitis 59.50 10.24 20 737215 12351 78994802
Cytomegalovirus viraemia 59.49 10.24 22 737213 12799 78994354
Intentional product use issue 59.46 10.24 1018 736217 151094 78856059
Pituitary tumour recurrent 59.29 10.24 31 737204 162 79006991
Respiratory failure 59.24 10.24 1248 735987 179663 78827490
Product formulation issue 59.14 10.24 58 737177 914 79006239
Abdominal pain upper 58.15 10.24 2578 734657 221241 78785912
Substance abuse 58.15 10.24 13 737222 10513 78996640
Aspergillus infection 57.82 10.24 55 737180 19106 78988047
Prostate cancer 57.40 10.24 140 737095 33128 78974025
Multiple-drug resistance 57.26 10.24 7 737228 8801 78998352
Enthesopathy 57.18 10.24 18 737217 11590 78995563
Full blood count abnormal 56.59 10.24 598 736637 39876 78967277
Pain in extremity 56.46 10.24 4004 733231 360534 78646619
Infective pulmonary exacerbation of cystic fibrosis 56.43 10.24 24 737211 12827 78994326
Therapeutic drug monitoring analysis not performed 56.20 10.24 79 737156 1857 79005296
Drug tolerance decreased 55.78 10.24 25 737210 12953 78994200
Pruritus genital 55.49 10.24 126 737109 4360 79002793
Thyroidectomy 55.08 10.24 55 737180 887 79006266
Atrial tachycardia 55.06 10.24 168 737067 6965 79000188
Sleep terror 54.91 10.24 125 737110 4333 79002820
Adenovirus infection 54.21 10.24 7 737228 8440 78998713
Malaise 54.21 10.24 5245 731990 484624 78522529
Tension headache 53.95 10.24 168 737067 7043 79000110
Papillary thyroid cancer 53.22 10.24 90 737145 2496 79004657
Exposure during pregnancy 53.20 10.24 638 736597 100494 78906659
Respiratory arrest 53.03 10.24 313 736922 57237 78949916
Mucosal inflammation 53.00 10.24 445 736790 75135 78932018
Thyroid hormones decreased 52.68 10.24 39 737196 408 79006745
Anxiety 52.51 10.24 2805 734430 245707 78761446
Gastrooesophageal reflux disease 52.30 10.24 1298 735937 102948 78904205
Condition aggravated 52.04 10.24 3958 733277 497166 78509987
Blood glucose increased 51.99 10.24 1412 735823 113563 78893590
Lip swelling 51.48 10.24 592 736643 40319 78966834
Pancytopenia 50.63 10.24 1156 736079 164589 78842564
Rheumatoid nodule 50.39 10.24 52 737183 17386 78989767
Dysphonia 50.35 10.24 772 736463 56100 78951053
Thrombocytopenia 49.95 10.24 1975 735260 263284 78743869
Carotid artery occlusion 49.86 10.24 170 737065 7477 78999676
Bone pain 49.86 10.24 758 736477 54984 78952169
Poisoning 49.64 10.24 99 737136 25173 78981980
Thyroxine free decreased 49.38 10.24 55 737180 1012 79006141
Tremor 49.35 10.24 1982 735253 168101 78839052
Graft versus host disease 49.12 10.24 40 737195 14986 78992167
Immune reconstitution inflammatory syndrome 48.90 10.24 34 737201 13807 78993346
Therapeutic response unexpected 48.82 10.24 334 736901 19612 78987541
Bone erosion 48.49 10.24 56 737179 17791 78989362
Oedema peripheral 48.10 10.24 2821 734414 249467 78757686
Insulin-like growth factor decreased 47.46 10.24 41 737194 544 79006609
Blood parathyroid hormone decreased 47.36 10.24 19 737216 10517 78996636
Disseminated intravascular coagulation 47.25 10.24 171 737064 35671 78971482
Tumour lysis syndrome 46.84 10.24 94 737141 23845 78983308
Blood thyroid stimulating hormone 46.76 10.24 14 737221 6 79007147
Rheumatoid arthritis 46.55 10.24 1520 735715 206950 78800203
Anaphylactic reaction 46.49 10.24 522 736713 83221 78923932
Diffuse alopecia 46.49 10.24 51 737184 922 79006231
Hip arthroplasty 46.21 10.24 172 737063 35584 78971569
Decreased appetite 45.98 10.24 3719 733516 338699 78668454
Flatulence 45.86 10.24 600 736635 42124 78965029
Rheumatic fever 45.41 10.24 125 737110 28400 78978753
Insomnia 45.33 10.24 2734 734501 242436 78764717
Visual impairment 45.28 10.24 1144 736091 90987 78916166
Thyroid hormones increased 45.12 10.24 38 737197 486 79006667
Device adhesion issue 45.08 10.24 6 737229 7069 79000084
Neutropenic sepsis 45.05 10.24 116 737119 26948 78980205
Therapeutic response decreased 44.92 10.24 398 736837 66455 78940698
Reaction to excipient 44.88 10.24 64 737171 1525 79005628
Product monitoring error 44.71 10.24 182 737053 8724 78998429
Nephropathy toxic 44.55 10.24 75 737160 20344 78986809
Dysphagia 44.40 10.24 1460 735775 120676 78886477
Memory impairment 44.39 10.24 1350 735885 110384 78896769
Therapeutic product effect incomplete 44.37 10.24 984 736251 140661 78866492
Blood pressure increased 44.30 10.24 2384 734851 208976 78798177
Hypertension 44.13 10.24 3593 733642 327399 78679754
Thyroxine increased 43.94 10.24 44 737191 712 79006441
Reversible airways obstruction 43.81 10.24 75 737160 2101 79005052
Gestational diabetes 43.79 10.24 143 737092 6150 79001003
Drug reaction with eosinophilia and systemic symptoms 43.37 10.24 382 736853 63862 78943291
Sickle cell anaemia with crisis 43.33 10.24 10 737225 7912 78999241
Oral pain 43.14 10.24 467 736768 31331 78975822
Joint destruction 43.06 10.24 3 737232 5922 79001231
Gait disturbance 42.79 10.24 2337 734898 205169 78801984
Immunisation 42.73 10.24 74 737161 2093 79005060
Dyspnoea 42.39 10.24 8752 728483 848273 78158880
Hip fracture 42.31 10.24 453 736782 30308 78976845
Thrombotic microangiopathy 42.26 10.24 76 737159 20093 78987060
Cytomegalovirus infection reactivation 42.08 10.24 14 737221 8702 78998451
Mucormycosis 41.96 10.24 13 737222 8456 78998697
Psoriasis 41.86 10.24 1105 736130 88482 78918671
Facial pain 41.82 10.24 225 737010 12125 78995028
Aplastic anaemia 41.68 10.24 63 737172 17842 78989311
Tri-iodothyronine decreased 41.67 10.24 29 737206 273 79006880
Epstein-Barr virus infection 41.64 10.24 43 737192 14373 78992780
Acute graft versus host disease in skin 41.23 10.24 10 737225 7648 78999505
BK virus infection 41.03 10.24 15 737220 8789 78998364
Polyomavirus-associated nephropathy 40.46 10.24 3 737232 5624 79001529
Chronic graft versus host disease 40.35 10.24 7 737228 6774 79000379
Liver injury 39.39 10.24 334 736901 56280 78950873
Graft versus host disease in gastrointestinal tract 39.07 10.24 6 737229 6350 79000803
Foreign body in reproductive tract 38.90 10.24 39 737196 632 79006521
Dry mouth 38.39 10.24 1076 736159 86943 78920210
Colorectal cancer 38.21 10.24 16 737219 8631 78998522
Systemic infection 38.14 10.24 185 737050 9567 78997586
Cardiogenic shock 38.06 10.24 229 737006 41685 78965468
Hypophysitis 37.83 10.24 104 737131 4062 79003091
Transplant dysfunction 37.78 10.24 10 737225 7211 78999942
Swollen joint count increased 37.60 10.24 99 737136 22828 78984325
Weight decreased 37.33 10.24 3790 733445 351408 78655745
Red blood cell sedimentation rate 37.23 10.24 4 737231 5561 79001592
Anti-cyclic citrullinated peptide antibody 37.20 10.24 5 737230 5847 79001306
General physical health deterioration 37.03 10.24 2990 734245 272248 78734905
Psoriatic arthropathy 36.96 10.24 503 736732 77496 78929657
Influenza like illness 36.91 10.24 896 736339 70811 78936342
Tinnitus 36.67 10.24 595 736640 43738 78963415
Drug use disorder 36.66 10.24 17 737218 8634 78998519
Thyroid cancer recurrent 36.47 10.24 13 737222 19 79007134
Pulmonary malformation 36.01 10.24 24 737211 209 79006944
Acute myeloid leukaemia 35.85 10.24 155 737080 30730 78976423
Oesophageal carcinoma 35.62 10.24 30 737205 11054 78996099
Burning sensation 35.29 10.24 749 736486 57883 78949270
Therapy partial responder 35.17 10.24 67 737168 17330 78989823
Hypopituitarism 35.08 10.24 89 737146 3310 79003843
Cerebrovascular accident 35.04 10.24 1764 735471 153528 78853625
Myxoedema 34.64 10.24 20 737215 131 79007022
Graft versus host disease in skin 34.57 10.24 7 737228 6066 79001087
Hypoglycaemia 34.28 10.24 1204 736031 100390 78906763
Device difficult to use 34.25 10.24 44 737191 13341 78993812
Cytomegalovirus chorioretinitis 34.17 10.24 5 737230 5485 79001668
Ageusia 34.11 10.24 267 736968 16365 78990788
Coma 33.91 10.24 691 736544 99958 78907195
Dystonia 33.89 10.24 94 737141 21305 78985848
Tenderness 33.84 10.24 351 736884 23291 78983862
Incorrect route of product administration 33.77 10.24 187 737048 34742 78972411
Pseudomonas infection 33.72 10.24 91 737144 20812 78986341
Nocardiosis 33.49 10.24 6 737229 5673 79001480
Nervousness 33.29 10.24 463 736772 32952 78974201
Bacteraemia 33.25 10.24 173 737062 32651 78974502
Swollen tongue 33.24 10.24 566 736669 42004 78965149
Diplopia 33.05 10.24 463 736772 33003 78974150
Eye pruritus 32.65 10.24 312 736923 20258 78986895
Blood test abnormal 32.39 10.24 277 736958 17433 78989720
Alanine aminotransferase increased 32.21 10.24 1203 736032 161367 78845786
Respiratory depression 31.87 10.24 139 737096 27491 78979662
Multiple allergies 31.72 10.24 185 737050 10275 78996878
Exposure to toxic agent 31.69 10.24 23 737212 9135 78998018
Acute respiratory distress syndrome 31.55 10.24 258 736977 43809 78963344
Skin necrosis 31.29 10.24 76 737159 18011 78989142
Retinitis 31.11 10.24 7 737228 5636 79001517
Body height decreased 30.89 10.24 159 737076 8421 78998732
Muscle twitching 30.56 10.24 357 736878 24407 78982746
Cardiotoxicity 30.53 10.24 41 737194 12198 78994955
Chronic pigmented purpura 30.53 10.24 22 737213 220 79006933
Back pain 30.29 10.24 3234 734001 300946 78706207
Epiphysiolysis 30.25 10.24 17 737218 105 79007048
Chest pain 30.19 10.24 3016 734219 279288 78727865
Metastatic renal cell carcinoma 30.09 10.24 67 737168 2288 79004865
Sedation 29.97 10.24 659 736576 51236 78955917
Breast cancer stage III 29.89 10.24 28 737207 9798 78997355
Pneumonia 29.71 10.24 5514 731721 654732 78352421
Poisoning deliberate 29.60 10.24 83 737152 18745 78988408
Vital capacity decreased 29.46 10.24 57 737178 1759 79005394
Tri-iodothyronine increased 29.34 10.24 22 737213 235 79006918
Goitre 29.25 10.24 115 737120 5424 79001729
Dry eye 29.19 10.24 492 736743 36439 78970714
Rash 29.18 10.24 4800 732435 573558 78433595
Sleep disorder due to a general medical condition 29.17 10.24 229 737006 14048 78993105
Trichorrhexis 29.13 10.24 37 737198 786 79006367
Alanine aminotransferase abnormal 28.50 10.24 24 737211 8843 78998310
Skin haemorrhage 28.36 10.24 199 737036 11782 78995371
Pulmonary tuberculosis 28.21 10.24 19 737216 7846 78999307
Thyrotoxic crisis 28.18 10.24 46 737189 1238 79005915
Ventricular fibrillation 28.17 10.24 176 737059 31750 78975403
Gallbladder disorder 28.10 10.24 288 736947 19052 78988101
Tropical infectious disease 28.01 10.24 12 737223 36 79007117
Cardiac disorder 27.88 10.24 801 736434 64956 78942197
Lymphocyte count decreased 27.75 10.24 291 736944 46998 78960155
Eye swelling 27.70 10.24 370 736865 26098 78981055
Disorientation 27.53 10.24 768 736467 62008 78945145
Feeling cold 27.39 10.24 395 736840 28334 78978819
Jaw disorder 27.30 10.24 105 737130 4901 79002252
Adverse event 27.21 10.24 392 736843 59822 78947331
Bladder cancer 27.19 10.24 91 737144 19435 78987718
Unintentional medical device removal 27.17 10.24 19 737216 7693 78999460
Breast cancer stage I 27.12 10.24 14 737221 6686 79000467
Autoimmune hepatitis 26.90 10.24 194 737041 11589 78995564
Nephritic syndrome 26.86 10.24 26 737209 403 79006750
Haematoma 26.80 10.24 652 736583 51543 78955610
Myelodysplastic syndrome 26.76 10.24 167 737068 30134 78977019
Eating disorder 26.72 10.24 301 736934 20396 78986757
Somatic delusion 26.56 10.24 33 737202 685 79006468
Pancreatic neuroendocrine tumour 26.55 10.24 32 737203 643 79006510
Pneumonia fungal 26.52 10.24 39 737196 11171 78995982
Ankylosing spondylitis 26.47 10.24 45 737190 12160 78994993
Atrioventricular block 26.41 10.24 221 737014 13820 78993333
Tenosynovitis 26.40 10.24 66 737169 15488 78991665
Haemorrhoids 26.40 10.24 397 736838 28731 78978422
Product physical issue 26.38 10.24 92 737143 4093 79003060
Spinal stenosis 26.31 10.24 242 736993 15549 78991604
Paradoxical drug reaction 26.26 10.24 17 737218 7168 78999985
Change of bowel habit 26.21 10.24 70 737165 2687 79004466
Hypogammaglobulinaemia 26.07 10.24 50 737185 12901 78994252
Swelling face 26.06 10.24 852 736383 70360 78936793
Diffuse large B-cell lymphoma recurrent 25.80 10.24 4 737231 4203 79002950
Posterior reversible encephalopathy syndrome 25.80 10.24 140 737095 26141 78981012
Serotonin syndrome 25.65 10.24 279 736956 44748 78962405
Eye irritation 25.46 10.24 298 736937 20383 78986770
Status epilepticus 25.35 10.24 132 737103 24909 78982244
Product odour abnormal 25.34 10.24 45 737190 1299 79005854
Interstitial lung disease 25.11 10.24 821 736414 111779 78895374
Product taste abnormal 25.06 10.24 61 737174 2210 79004943
Labyrinthitis 24.84 10.24 71 737164 2837 79004316
Arrhythmia 24.78 10.24 742 736493 60530 78946623
Subarachnoid haemorrhage 24.78 10.24 340 736895 24125 78983028
Drug eruption 24.72 10.24 273 736962 43662 78963491
Hypersomnia 24.69 10.24 324 736911 22762 78984391
Enterococcal infection 24.65 10.24 69 737166 15591 78991562
Rhinitis allergic 24.64 10.24 196 737039 12073 78995080
Malabsorption 24.60 10.24 102 737133 4930 79002223
Urine odour abnormal 24.53 10.24 119 737116 6154 79000999
Product dose omission issue 24.52 10.24 2631 734604 244906 78762247
Gastric cancer 24.49 10.24 35 737200 10144 78997009
Accidental exposure to product 24.48 10.24 179 737056 31143 78976010
Pain of skin 24.37 10.24 224 737011 14389 78992764
Secondary hypogonadism 24.30 10.24 23 737212 346 79006807
Juvenile idiopathic arthritis 24.16 10.24 7 737228 4756 79002397
Temperature regulation disorder 24.04 10.24 12 737223 5841 79001312
Scleral discolouration 24.01 10.24 29 737206 584 79006569
Head injury 24.01 10.24 482 736753 36887 78970266
Blindness 23.87 10.24 382 736853 28001 78979152
Nasopharyngitis 23.86 10.24 2021 735214 251860 78755293
Immunosuppressant drug level increased 23.80 10.24 29 737206 8998 78998155
Cerebral haematoma 23.78 10.24 140 737095 7802 78999351
Granulocytopenia 23.72 10.24 184 737051 11247 78995906
Pneumatosis intestinalis 23.56 10.24 15 737220 6382 79000771
Alopecia 23.53 10.24 1830 735405 229525 78777628
Pelvic fracture 23.44 10.24 193 737042 12011 78995142
Migraine 23.41 10.24 1011 736224 86482 78920671
Hyperhidrosis 23.41 10.24 1664 735571 149828 78857325
Hypertensive crisis 23.27 10.24 294 736941 20476 78986677
Hypoacusis 23.23 10.24 400 736835 29750 78977403
Appendicitis 23.14 10.24 106 737129 20688 78986465
Growth hormone deficiency 23.08 10.24 24 737211 407 79006746
Oral discomfort 23.04 10.24 162 737073 9598 78997555
Viral mutation identified 22.92 10.24 4 737231 3854 79003299
Pre-existing condition improved 22.82 10.24 107 737128 5456 79001697
Blood growth hormone increased 22.81 10.24 31 737204 705 79006448
Staphylococcal infection 22.81 10.24 390 736845 57905 78949248
Diverticulum 22.69 10.24 224 737011 14672 78992481
Lipodystrophy acquired 22.61 10.24 6 737229 4319 79002834
Blood glucose decreased 22.41 10.24 354 736881 25880 78981273
Lymphoproliferative disorder 22.34 10.24 12 737223 5603 79001550
Chronic sinusitis 22.33 10.24 55 737180 12971 78994182
Febrile bone marrow aplasia 22.30 10.24 55 737180 12965 78994188
Exposure via ingestion 22.18 10.24 10 737225 5164 79001989
Medulloblastoma recurrent 22.18 10.24 14 737221 110 79007043
Abdominal pain lower 22.13 10.24 415 736820 31367 78975786
Cystitis 21.98 10.24 641 736594 52091 78955062
Ascites 21.95 10.24 531 736704 75031 78932122
Anti-thyroid antibody positive 21.78 10.24 25 737210 476 79006677
Broncholithiasis 21.77 10.24 18 737217 224 79006929
Systemic candida 21.74 10.24 18 737217 6688 79000465
Platelet count decreased 21.67 10.24 1528 735707 193136 78814017
Thyroxine decreased 21.54 10.24 33 737202 840 79006313
Sciatica 21.50 10.24 429 736806 32793 78974360
Product colour issue 21.35 10.24 33 737202 847 79006306
Papillitis 21.25 10.24 13 737222 96 79007057
Adrenal insufficiency 21.25 10.24 376 736859 28111 78979042
Palmar-plantar erythrodysaesthesia syndrome 21.16 10.24 427 736808 32707 78974446
Rash papular 21.16 10.24 302 736933 21614 78985539
Retrograde amnesia 21.10 10.24 27 737208 578 79006575
Gingival pain 21.04 10.24 149 737086 8849 78998304
Multiple drug therapy 21.00 10.24 84 737151 3994 79003159
Vaginal haemorrhage 20.81 10.24 300 736935 21517 78985636
Cerebral infarction 20.76 10.24 297 736938 45379 78961774
Pneumonia cytomegaloviral 20.69 10.24 10 737225 4959 79002194
Lung cyst 20.61 10.24 20 737215 311 79006842
Low turnover osteopathy 20.50 10.24 52 737183 1934 79005219
Intercepted product preparation error 20.48 10.24 4 737231 3556 79003597
Kounis syndrome 20.46 10.24 7 737228 4275 79002878
Hiatus hernia 20.46 10.24 316 736919 22996 78984157
Choking 20.44 10.24 186 737049 11915 78995238
Disability 20.44 10.24 85 737150 17035 78990118
Brain oedema 20.41 10.24 143 737092 25120 78982033
Inner ear disorder 20.40 10.24 28 737207 643 79006510
Upper-airway cough syndrome 20.40 10.24 181 737054 11512 78995641
Pemphigoid 20.35 10.24 224 737011 15091 78992062
Cytopenia 20.33 10.24 108 737127 20275 78986878
Bradycardia 20.26 10.24 1485 735750 134072 78873081
Altered state of consciousness 20.26 10.24 284 736951 43538 78963615
Diabetes insipidus 20.23 10.24 99 737136 5138 79002015
Soft tissue disorder 20.23 10.24 75 737160 3440 79003713
Rib deformity 20.21 10.24 17 737218 217 79006936
Rheumatoid lung 20.18 10.24 7 737228 4238 79002915
Head discomfort 20.14 10.24 214 737021 14288 78992865
Electrocardiogram ST segment elevation 20.08 10.24 29 737206 8368 78998785
Thyroiditis 19.95 10.24 90 737145 4515 79002638
Liver function test abnormal 19.78 10.24 756 736479 63719 78943434
Virologic failure 19.77 10.24 7 737228 4184 79002969
COVID-19 pneumonia 19.71 10.24 171 737064 28678 78978475
Drug abuser 19.66 10.24 16 737219 5997 79001156
Haematochezia 19.64 10.24 995 736240 86650 78920503
Kidney transplant rejection 19.39 10.24 41 737194 10205 78996948
Knee arthroplasty 19.38 10.24 282 736953 42966 78964187
Lip blister 19.36 10.24 63 737172 2704 79004449
Tooth fracture 19.36 10.24 177 737058 11353 78995800
Intentional self-injury 19.23 10.24 199 737036 32220 78974933
Hyperbilirubinaemia 19.22 10.24 140 737095 24378 78982775
Intervertebral disc protrusion 19.15 10.24 316 736919 23305 78983848
Tongue discomfort 19.14 10.24 58 737177 2395 79004758
Complication of device insertion 19.06 10.24 112 737123 6238 79000915
Gastrointestinal motility disorder 19.04 10.24 109 737126 6013 79001140
Thyroid cancer metastatic 19.00 10.24 15 737220 174 79006979
Acute lymphocytic leukaemia recurrent 18.93 10.24 10 737225 4714 79002439
Poor quality product administered 18.70 10.24 75 737160 3570 79003583
Blood calcium increased 18.67 10.24 162 737073 10238 78996915
Nasal obstruction 18.64 10.24 53 737182 2111 79005042
Acute graft versus host disease in intestine 18.64 10.24 7 737228 4034 79003119
Lymphadenectomy 18.60 10.24 38 737197 1221 79005932
Exophthalmos 18.59 10.24 46 737189 1684 79005469
Immune effector cell-associated neurotoxicity syndrome 18.58 10.24 16 737219 5832 79001321
Extremity contracture 18.56 10.24 46 737189 1686 79005467
Persistent depressive disorder 18.55 10.24 37 737198 1168 79005985
Pollakiuria 18.51 10.24 464 736771 36853 78970300
Inflammation 18.51 10.24 694 736541 93059 78914094
Red blood cell sedimentation rate increased 18.41 10.24 306 736929 45636 78961517
Neurologic neglect syndrome 18.41 10.24 64 737171 2843 79004310
Labile hypertension 18.36 10.24 24 737211 525 79006628
Blood phosphorus increased 18.28 10.24 43 737192 10304 78996849
Injection site mass 18.25 10.24 275 736960 19909 78987244
Pituitary tumour 18.19 10.24 37 737198 1185 79005968
Throat clearing 18.19 10.24 60 737175 2594 79004559
Bladder disorder 18.18 10.24 146 737089 9019 78998134
Breast discomfort 18.17 10.24 21 737214 403 79006750
Erythema dyschromicum perstans 18.16 10.24 10 737225 59 79007094
Tooth dislocation 17.99 10.24 8 737227 27 79007126
Cryptococcosis 17.97 10.24 5 737230 3488 79003665
Leukopenia 17.90 10.24 887 736348 115626 78891527
Venoocclusive disease 17.86 10.24 10 737225 4563 79002590
Abnormal uterine bleeding 17.80 10.24 34 737201 1039 79006114
Product measured potency issue 17.80 10.24 15 737220 192 79006961
Increased tendency to bruise 17.75 10.24 161 737074 10303 78996850
Hyperchromic anaemia 17.69 10.24 14 737221 163 79006990
Oculogyric crisis 17.67 10.24 3 737232 2949 79004204
Staphylococcal sepsis 17.65 10.24 73 737162 14653 78992500
Granuloma 17.62 10.24 31 737204 8266 78998887
Thyroxine abnormal 17.58 10.24 6 737229 7 79007146
Depression 17.57 10.24 2275 734960 214515 78792638
Upper limb fracture 17.51 10.24 248 736987 17719 78989434
Gastritis 17.51 10.24 574 736661 47419 78959734
Ejection fraction abnormal 17.48 10.24 56 737179 2384 79004769
Sexual dysfunction 17.42 10.24 28 737207 7735 78999418
Respiratory tract malformation 17.41 10.24 12 737223 111 79007042
Seronegative arthritis 17.29 10.24 11 737224 4681 79002472
Application site erythema 17.23 10.24 93 737142 5017 79002136
Dyspnoea exertional 17.21 10.24 977 736258 86096 78921057
Anaphylactic shock 17.10 10.24 232 737003 35764 78971389
Viraemia 16.99 10.24 3 737232 2866 79004287
Adenoiditis 16.96 10.24 8 737227 32 79007121
Endocrine disorder 16.95 10.24 29 737206 812 79006341
Drug specific antibody present 16.88 10.24 22 737213 6630 79000523
Amniotic fluid volume increased 16.88 10.24 13 737222 145 79007008
Pneumonia bacterial 16.83 10.24 107 737128 19224 78987929
Cholelithiasis 16.75 10.24 620 736615 52044 78955109
Stenotrophomonas infection 16.64 10.24 7 737228 3766 79003387
Hyponatraemic seizure 16.64 10.24 23 737212 532 79006621
Milk-alkali syndrome 16.59 10.24 39 737196 1381 79005772
Fungaemia 16.59 10.24 11 737224 4580 79002573
Faeces discoloured 16.54 10.24 369 736866 28758 78978395
Disturbance in social behaviour 16.54 10.24 13 737222 4957 79002196
Aggression 16.52 10.24 352 736883 50606 78956547
Arterial occlusive disease 16.39 10.24 134 737101 8322 78998831
Product tampering 16.36 10.24 20 737215 408 79006745
Parainfluenzae virus infection 16.35 10.24 17 737218 5665 79001488
Sinus bradycardia 16.33 10.24 326 736909 24921 78982232
Follicular thyroid cancer 16.33 10.24 10 737225 74 79007079
Delayed graft function 16.30 10.24 6 737229 3501 79003652
Lactose intolerance 16.26 10.24 53 737182 2277 79004876
Drug level increased 16.25 10.24 263 736972 39388 78967765
Spinal osteoarthritis 16.24 10.24 233 737002 16694 78990459
Acinetobacter infection 16.23 10.24 3 737232 2774 79004379
Vascular stent thrombosis 16.18 10.24 7 737228 3703 79003450
Medullary thyroid cancer 16.17 10.24 16 737219 255 79006898
Thyroglobulin decreased 16.14 10.24 5 737230 3 79007150
Total lung capacity abnormal 16.10 10.24 15 737220 221 79006932
Traumatic ulcer 16.09 10.24 9 737226 55 79007098
Potassium wasting nephropathy 16.04 10.24 13 737222 157 79006996
Oropharyngeal pain 15.84 10.24 1195 736040 108158 78898995
Eye disorder 15.72 10.24 304 736931 23108 78984045
Polyhydramnios 15.68 10.24 43 737192 1677 79005476
Abdominal distension 15.61 10.24 1297 735938 118353 78888800
Neuroleptic malignant syndrome 15.60 10.24 171 737064 27388 78979765
Breast cancer 15.58 10.24 416 736819 33365 78973788
Device use error 15.57 10.24 26 737209 7075 79000078
Cataract 15.56 10.24 713 736522 61407 78945746
Bronchitis 15.47 10.24 1406 735829 129238 78877915
Pleural neoplasm 15.39 10.24 18 737217 350 79006803
Meniere's disease 15.39 10.24 13 737222 167 79006986
Bacterial sepsis 15.35 10.24 33 737202 8165 78998988
Rotator cuff repair 15.34 10.24 45 737190 1825 79005328
Hyperthermia malignant 15.34 10.24 4 737231 2913 79004240
Forced vital capacity decreased 15.32 10.24 43 737192 1700 79005453
Varicose vein 15.30 10.24 81 737154 4338 79002815
Infection reactivation 15.26 10.24 3 737232 2654 79004499
Lymph node calcification 15.23 10.24 19 737216 396 79006757
Product solubility abnormal 15.15 10.24 30 737205 942 79006211
Skin toxicity 15.13 10.24 34 737201 8280 78998873
Intercapillary glomerulosclerosis 15.10 10.24 9 737226 63 79007090
Primary hypothyroidism 15.08 10.24 13 737222 172 79006981
Acute hepatic failure 15.06 10.24 192 737043 29921 78977232
Decreased bronchial secretion 14.99 10.24 9 737226 64 79007089
Claustrophobia 14.97 10.24 35 737200 1235 79005918
Acute lung injury 14.93 10.24 5 737230 3095 79004058
Feeling jittery 14.91 10.24 183 737052 12658 78994495
Pulmonary alveolar haemorrhage 14.88 10.24 55 737180 11402 78995751
Diabetic ketoacidosis 14.83 10.24 417 736818 33705 78973448
Dementia 14.83 10.24 315 736920 24344 78982809
Magnetic resonance imaging thoracic abnormal 14.78 10.24 6 737229 15 79007138
Tonsillar cyst 14.77 10.24 4 737231 0 79007153
Metabolic acidosis 14.76 10.24 618 736617 81911 78925242
Blood loss anaemia 14.74 10.24 213 737022 15285 78991868
Meningitis cryptococcal 14.69 10.24 7 737228 3499 79003654
Cytomegalovirus colitis 14.67 10.24 13 737222 4672 79002481
Nephrectomy 14.66 10.24 48 737187 2067 79005086
Polyglandular autoimmune syndrome type II 14.66 10.24 7 737228 29 79007124
Basal cell carcinoma 14.63 10.24 250 736985 37125 78970028
Vaccination site reaction 14.63 10.24 11 737224 118 79007035
Blood sodium decreased 14.62 10.24 407 736828 32848 78974305
Pulmonary valve incompetence 14.61 10.24 45 737190 1875 79005278
Skin exfoliation 14.58 10.24 636 736599 54464 78952689
Orthostatic intolerance 14.56 10.24 45 737190 1879 79005274
Product dispensing error 14.54 10.24 187 737048 13076 78994077
Thyrotoxic periodic paralysis 14.54 10.24 12 737223 149 79007004
Asthma 14.52 10.24 1444 735791 133651 78873502
Anaemia folate deficiency 14.42 10.24 16 737219 293 79006860
Hepatitis B 14.42 10.24 35 737200 8297 78998856
Hormone level abnormal 14.39 10.24 46 737189 1956 79005197
Transplant failure 14.38 10.24 13 737222 4628 79002525
Eye pain 14.37 10.24 452 736783 37126 78970027
Anaemia vitamin B12 deficiency 14.36 10.24 26 737209 762 79006391
Anal prolapse 14.33 10.24 9 737226 70 79007083
Wrist fracture 14.33 10.24 171 737064 11750 78995403
Autoimmune dermatitis 14.28 10.24 12 737223 153 79007000
Sputum culture positive 14.27 10.24 71 737164 3710 79003443
Listless 14.22 10.24 72 737163 3789 79003364
Candida infection 14.20 10.24 258 736977 37956 78969197
Poor sucking reflex 14.19 10.24 11 737224 124 79007029
N-terminal prohormone brain natriuretic peptide abnormal 14.17 10.24 15 737220 260 79006893
Gastric pH increased 14.16 10.24 8 737227 50 79007103
Congenital central nervous system anomaly 14.16 10.24 8 737227 50 79007103
Ventilation perfusion mismatch 14.14 10.24 23 737212 617 79006536
Neutrophil count increased 14.13 10.24 189 737046 29207 78977946
Sprue-like enteropathy 14.12 10.24 35 737200 1283 79005870
Nerve compression 14.10 10.24 139 737096 9100 78998053
Vomiting 14.10 10.24 6575 730660 659253 78347900
Transcription medication error 14.05 10.24 19 737216 430 79006723
Pain threshold decreased 14.01 10.24 6 737229 18 79007135
Vessel puncture site haemorrhage 13.98 10.24 13 737222 191 79006962
Drug level decreased 13.98 10.24 77 737158 14325 78992828
Ileus paralytic 13.97 10.24 44 737191 9576 78997577
Tonsillar disorder 13.96 10.24 34 737201 1232 79005921
Respiratory disorder 13.93 10.24 312 736923 44544 78962609
Cortisol decreased 13.91 10.24 48 737187 2124 79005029
Speech disorder 13.87 10.24 626 736609 53819 78953334
Pulse abnormal 13.82 10.24 65 737170 3319 79003834
Needle issue 13.81 10.24 183 737052 12885 78994268
Cervicogenic headache 13.79 10.24 7 737228 34 79007119
Femur fracture 13.77 10.24 461 736774 38191 78968962
Lipoma excision 13.77 10.24 6 737229 19 79007134
Cytomegalovirus test positive 13.77 10.24 21 737214 5926 79001227
Pleural fibrosis 13.74 10.24 11 737224 4156 79002997
Scar 13.72 10.24 207 737028 14989 78992164
Lactation disorder 13.72 10.24 14 737221 232 79006921
Spondylolisthesis 13.71 10.24 62 737173 3113 79004040
International normalised ratio increased 13.67 10.24 934 736301 83787 78923366
Angina pectoris 13.66 10.24 597 736638 51135 78956018
Atrioventricular block first degree 13.65 10.24 176 737059 12315 78994838
Cerebral microangiopathy 13.64 10.24 15 737220 272 79006881
Anosognosia 13.63 10.24 9 737226 3755 79003398
Hair colour changes 13.59 10.24 76 737159 4156 79002997
Pulmonary arterial hypertension 13.57 10.24 351 736884 28015 78979138
Gene mutation 13.53 10.24 4 737231 2682 79004471
Rapid eye movement sleep behaviour disorder 13.50 10.24 19 737216 447 79006706
Skin ulcer 13.50 10.24 389 736846 53761 78953392
Body height increased 13.49 10.24 11 737224 134 79007019
Dysstasia 13.47 10.24 344 736891 27402 78979751
Frontotemporal dementia 13.45 10.24 22 737213 593 79006560
Product administered to patient of inappropriate age 13.45 10.24 19 737216 5534 79001619
Rectal polyp 13.42 10.24 40 737195 1637 79005516
Pituitary cyst 13.40 10.24 5 737230 9 79007144
Gingival disorder 13.38 10.24 68 737167 3583 79003570
Dyspepsia 13.37 10.24 1173 736062 107514 78899639
Ingrowing nail 13.37 10.24 57 737178 2790 79004363
Panic disorder 13.36 10.24 59 737176 2933 79004220
Intentional underdose 13.36 10.24 50 737185 2304 79004849
Bundle branch block left 13.34 10.24 164 737071 11349 78995804
Presbyacusis 13.33 10.24 4 737231 2656 79004497
Complications of transplanted kidney 13.33 10.24 24 737211 6342 79000811
Bacterial infection 13.32 10.24 206 737029 31074 78976079
Affect lability 13.31 10.24 161 737074 11098 78996055
Neuromyopathy 13.27 10.24 38 737197 1520 79005633
Endocrine ophthalmopathy 13.25 10.24 24 737211 704 79006449
Abnormal weight gain 13.25 10.24 54 737181 2590 79004563
Progressive multifocal leukoencephalopathy 13.24 10.24 124 737111 20476 78986677
Sinus congestion 13.24 10.24 258 736977 19638 78987515
Mydriasis 13.23 10.24 102 737133 17541 78989612
Renal impairment 13.21 10.24 1267 735968 156516 78850637
Post procedural hypothyroidism 13.17 10.24 11 737224 139 79007014
Musculoskeletal discomfort 13.13 10.24 257 736978 19578 78987575
Neutrophil function disorder 13.12 10.24 6 737229 22 79007131
Urinary incontinence 13.10 10.24 482 736753 40427 78966726
Drug tolerance 13.08 10.24 39 737196 8636 78998517
Foetal death 12.99 10.24 35 737200 8009 78999144
Oesophageal disorder 12.99 10.24 54 737181 2613 79004540
Oesophageal achalasia 12.98 10.24 25 737210 769 79006384
Dislocation of vertebra 12.94 10.24 34 737201 7846 78999307
Wrong patient received product 12.93 10.24 80 737155 4538 79002615
Groin pain 12.93 10.24 181 737054 12899 78994254
Shock 12.93 10.24 305 736930 43243 78963910
No adverse event 12.92 10.24 254 736981 36938 78970215
Device related infection 12.91 10.24 231 737004 34063 78973090
Pulmonary pain 12.85 10.24 78 737157 4395 79002758
Immediate post-injection reaction 12.85 10.24 16 737219 333 79006820
Retching 12.83 10.24 230 737005 17237 78989916
Empty sella syndrome 12.82 10.24 9 737226 86 79007067
Germ cell cancer 12.82 10.24 12 737223 178 79006975
Pregnancy 12.77 10.24 173 737062 26678 78980475
Mineral deficiency 12.75 10.24 7 737228 41 79007112
Stress fracture 12.73 10.24 103 737132 6377 79000776
Product blister packaging issue 12.66 10.24 13 737222 217 79006936
Deep brain stimulation 12.66 10.24 8 737227 63 79007090
Pneumonia pseudomonal 12.63 10.24 22 737213 5889 79001264
Supraventricular extrasystoles 12.63 10.24 109 737126 6878 79000275
Tongue haematoma 12.57 10.24 13 737222 219 79006934
Liver function test normal 12.56 10.24 4 737231 3 79007150
Diffuse alveolar damage 12.54 10.24 9 737226 3595 79003558
Intervertebral disc disorder 12.53 10.24 82 737153 4743 79002410
Bone loss 12.52 10.24 52 737183 2515 79004638
Muscle fatigue 12.52 10.24 65 737170 3454 79003699
Pneumonia aspiration 12.50 10.24 499 736736 66468 78940685
Blood calcitonin increased 12.49 10.24 7 737228 43 79007110
Piloerection 12.42 10.24 19 737216 483 79006670
Periorbital inflammation 12.41 10.24 9 737226 91 79007062
Cough 12.37 10.24 3684 733551 363105 78644048
Paternal exposure during pregnancy 12.36 10.24 8 737227 66 79007087
Sneezing 12.35 10.24 253 736982 19430 78987723
Erectile dysfunction 12.34 10.24 82 737153 14582 78992571
Embedded device 12.30 10.24 62 737173 3257 79003896
Full blood count decreased 12.29 10.24 330 736905 26489 78980664
Hypoglycaemic unconsciousness 12.24 10.24 31 737204 1152 79006001
Wrong patient 12.17 10.24 16 737219 352 79006801
Chromaturia 12.15 10.24 318 736917 25428 78981725
Senile osteoporosis 12.09 10.24 9 737226 95 79007058
Renal disorder 12.04 10.24 490 736745 41615 78965538
Angle closure glaucoma 12.03 10.24 57 737178 2919 79004234
Recalled product 12.03 10.24 27 737208 927 79006226
Intervertebral disc degeneration 12.01 10.24 209 737026 15576 78991577
Sputum increased 11.97 10.24 15 737220 4598 79002555
Miosis 11.97 10.24 91 737144 15698 78991455
Renal cancer metastatic 11.93 10.24 23 737212 708 79006445
Paraesthesia 11.93 10.24 1831 735404 174492 78832661
Urine sodium decreased 11.90 10.24 14 737221 274 79006879
Skin dystrophy 11.88 10.24 8 737227 71 79007082
Fanconi syndrome acquired 11.88 10.24 5 737230 2689 79004464
Fractured coccyx 11.87 10.24 28 737207 994 79006159
Cholecystitis chronic 11.87 10.24 142 737093 9764 78997389
Agranulocytosis 11.86 10.24 321 736914 44709 78962444
Acquired gene mutation 11.86 10.24 3 737232 2230 79004923
Ecchymosis 11.81 10.24 202 737033 15004 78992149
Tuberculosis 11.81 10.24 87 737148 15111 78992042
Hypotensive transfusion reaction 11.79 10.24 8 737227 72 79007081
Thyroid mass 11.73 10.24 70 737165 3920 79003233
Fear of injection 11.71 10.24 33 737202 7441 78999712
Brain natriuretic peptide abnormal 11.71 10.24 24 737211 773 79006380
Impaired driving ability 11.70 10.24 88 737147 5327 79001826
Mycobacterial infection 11.70 10.24 10 737225 3658 79003495
Upper respiratory tract inflammation 11.69 10.24 12 737223 4023 79003130
Coordination abnormal 11.69 10.24 225 737010 17087 78990066
Metastases to neck 11.68 10.24 6 737229 30 79007123
Blood potassium decreased 11.68 10.24 534 736701 45978 78961175
Haemoglobinaemia 11.67 10.24 14 737221 280 79006873
Adulterated product 11.67 10.24 14 737221 280 79006873
Coronary arterial stent insertion 11.60 10.24 24 737211 6020 79001133
Madarosis 11.57 10.24 54 737181 2748 79004405
Endometrial thickening 11.55 10.24 14 737221 283 79006870
Dilatation atrial 11.55 10.24 66 737169 3638 79003515
Vasculitis 11.54 10.24 309 736926 24793 78982360
Vertigo positional 11.50 10.24 61 737174 3269 79003884
Eosinophilia 11.49 10.24 325 736910 45020 78962133
Computerised tomogram thorax abnormal 11.48 10.24 4 737231 2415 79004738
Blood urea nitrogen/creatinine ratio increased 11.46 10.24 26 737209 899 79006254
Anion gap 11.45 10.24 3 737232 2178 79004975
Weight increased 11.44 10.24 2810 734425 274576 78732577
Pseudomonal sepsis 11.44 10.24 25 737210 6149 79001004
Basedow's disease 11.43 10.24 13 737222 245 79006908
Tooth abscess 11.40 10.24 212 737023 15998 78991155
Emotional distress 11.40 10.24 465 736770 39504 78967649
Drug specific antibody 11.39 10.24 5 737230 2623 79004530
Hypoxia 11.38 10.24 811 736424 102432 78904721
Gastrointestinal tract mucosal pigmentation 11.37 10.24 28 737207 1022 79006131
Sinus disorder 11.35 10.24 280 736955 22184 78984969
Carotid artery thrombosis 11.29 10.24 57 737178 2996 79004157
Starvation ketoacidosis 11.26 10.24 10 737225 138 79007015
Vulvovaginitis 11.25 10.24 14 737221 291 79006862
Hepatic failure 11.23 10.24 457 736778 60755 78946398
Therapeutic product effect increased 11.20 10.24 36 737199 1535 79005618
Retinal artery embolism 11.20 10.24 10 737225 139 79007014
Foetal exposure timing unspecified 11.20 10.24 7 737228 54 79007099
Injection site discomfort 11.19 10.24 84 737151 5082 79002071
Alcohol poisoning 11.19 10.24 17 737218 4804 79002349
Superficial vein prominence 11.18 10.24 8 737227 79 79007074
Nasal congestion 11.16 10.24 837 736398 75715 78931438
Chondromalacia 11.08 10.24 11 737224 176 79006977
Hysterotomy 11.08 10.24 3 737232 0 79007153
Blood proinsulin increased 11.08 10.24 3 737232 0 79007153
Primary hyperthyroidism 11.08 10.24 3 737232 0 79007153
Clear cell endometrial carcinoma 11.08 10.24 3 737232 0 79007153
Tri-iodothyronine free 11.08 10.24 3 737232 0 79007153
Thyroid pain 11.08 10.24 3 737232 0 79007153
Invasive papillary breast carcinoma 11.08 10.24 3 737232 0 79007153
Synovial cyst removal 11.08 10.24 3 737232 0 79007153
Pulmonary haemorrhage 11.07 10.24 85 737150 14632 78992521
Acute myeloid leukaemia recurrent 11.07 10.24 9 737226 3374 79003779
Dental caries 11.06 10.24 162 737073 11658 78995495
Pituitary haemorrhage 11.04 10.24 14 737221 297 79006856
Type 1 diabetes mellitus 11.01 10.24 105 737130 6814 79000339
Metastases to pituitary gland 11.00 10.24 5 737230 18 79007135
Delirium 10.99 10.24 655 736580 83972 78923181
Aspartate aminotransferase increased 10.95 10.24 1118 736117 137523 78869630
Supraventricular tachyarrhythmia 10.95 10.24 9 737226 111 79007042
Joint laxity 10.91 10.24 4 737231 2340 79004813
Toxic anterior segment syndrome 10.86 10.24 6 737229 2758 79004395
Product coating issue 10.86 10.24 8 737227 83 79007070
Tongue disorder 10.85 10.24 80 737155 13895 78993258
Astrocytoma 10.85 10.24 12 737223 219 79006934
Anaemia postoperative 10.79 10.24 40 737195 1834 79005319
Lymphatic system neoplasm 10.79 10.24 7 737228 58 79007095
Mean cell haemoglobin concentration increased 10.77 10.24 25 737210 878 79006275
Ischaemic stroke 10.77 10.24 391 736844 32740 78974413
Lung carcinoma cell type unspecified stage IV 10.76 10.24 3 737232 2090 79005063
Lens disorder 10.75 10.24 10 737225 147 79007006
Intermenstrual bleeding 10.74 10.24 92 737143 5792 79001361
Viral load increased 10.74 10.24 7 737228 2941 79004212
Cystic fibrosis 10.73 10.24 12 737223 3868 79003285
Presyncope 10.67 10.24 473 736762 40581 78966572
Chest injury 10.66 10.24 53 737182 2768 79004385
Chronic fatigue syndrome 10.65 10.24 32 737203 1315 79005838
Acetabulum fracture 10.63 10.24 20 737215 604 79006549
Rectocele 10.61 10.24 20 737215 605 79006548
Autoimmune hypothyroidism 10.61 10.24 13 737222 266 79006887
Sodium retention 10.60 10.24 11 737224 186 79006967
Pseudomembranous colitis 10.60 10.24 21 737214 5353 79001800
Onychoclasis 10.60 10.24 88 737147 5490 79001663
Hypoalbuminaemia 10.57 10.24 136 737099 21161 78985992
Alcohol interaction 10.54 10.24 18 737217 4856 79002297
Alcohol abuse 10.54 10.24 21 737214 5342 79001811
Meningioma 10.54 10.24 72 737163 4226 79002927
Polymyalgia rheumatica 10.53 10.24 75 737160 4462 79002691
Carcinoid tumour of the stomach 10.51 10.24 11 737224 188 79006965
Gastrointestinal tract irritation 10.49 10.24 21 737214 665 79006488
Ophthalmic vein thrombosis 10.47 10.24 12 737223 228 79006925
Hypothermia 10.46 10.24 280 736955 22466 78984687
Prophylaxis 10.45 10.24 4 737231 8 79007145
Rhinovirus infection 10.45 10.24 38 737197 7915 78999238
Food allergy 10.44 10.24 58 737177 10766 78996387
Female genital tract fistula 10.42 10.24 25 737210 5950 79001203
Pneumonia viral 10.41 10.24 130 737105 9028 78998125
Emotional disorder 10.41 10.24 189 737046 14198 78992955
Lichen nitidus 10.40 10.24 8 737227 89 79007064
Nervous system disorder 10.40 10.24 180 737055 26676 78980477
Vulvovaginal discomfort 10.39 10.24 39 737196 1799 79005354
Hyperammonaemia 10.39 10.24 60 737175 11033 78996120
Subcutaneous haematoma 10.38 10.24 52 737183 2725 79004428
Superficial injury of eye 10.37 10.24 11 737224 191 79006962
Bronchiectasis 10.37 10.24 145 737090 22241 78984912
Pulmonary function test decreased 10.36 10.24 36 737199 7601 78999552
Haemangioma of liver 10.35 10.24 30 737205 1208 79005945
Priapism 10.34 10.24 16 737219 4489 79002664
Leukoencephalopathy 10.34 10.24 38 737197 7891 78999262
Carcinoembryonic antigen 10.33 10.24 8 737227 90 79007063
Retroplacental haematoma 10.32 10.24 9 737226 121 79007032
Barrett's oesophagus 10.32 10.24 23 737212 786 79006367
Pure white cell aplasia 10.32 10.24 7 737228 63 79007090
Hepatitis B reactivation 10.30 10.24 26 737209 6082 79001071
Nasal polyps 10.30 10.24 34 737201 7293 78999860
Antinuclear antibody positive 10.30 10.24 115 737120 7775 78999378
CREST syndrome 10.30 10.24 17 737218 462 79006691
Temperature intolerance 10.29 10.24 136 737099 9569 78997584
Maternal exposure timing unspecified 10.29 10.24 24 737211 5768 79001385
Ovarian adenoma 10.27 10.24 12 737223 233 79006920
Application site vesicles 10.27 10.24 33 737202 1407 79005746
Hospice care 10.26 10.24 143 737092 10181 78996972

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Small for dates baby 30.84 17.65 147 2165 2662 84818
Premature baby 28.90 17.65 36 2276 3892 83588
Atrial septal defect 19.51 17.65 141 2171 2978 84502

Pharmacologic Action:

SourceCodeDescription
ATC H03AA01 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
THYROID THERAPY
THYROID PREPARATIONS
Thyroid hormones
ATC H03AA51 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
THYROID THERAPY
THYROID PREPARATIONS
Thyroid hormones
FDA CS M0021504 Thyroxine
FDA EPC N0000175945 l-Thyroxine
CHEBI has role CHEBI:50671 antithyroid drugs
CHEBI has role CHEBI:60311 thyroid hormones
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:52290 mitogens
CHEBI has role CHEBI:53000 epitope role

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

DiseaseRelationSNOMED_IDDOID
Goiter indication 3716002 DOID:12176
Hashimoto thyroiditis indication 21983002
Hypothyroidism indication 40930008 DOID:1459
Myxedema indication 43153006 DOID:11634
Hyperlipidemia indication 55822004 DOID:1168
Congenital hypothyroidism indication 190268003 DOID:0050328
Malignant tumor of thyroid gland indication 363478007 DOID:1781
Diagnostic Test for Thyroid Dysfunction indication
Myxedema coma off-label use 21263006
Myocardial infarction contraindication 22298006 DOID:5844
Thyrotoxic crisis contraindication 29028009 DOID:12837
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Osteoporosis contraindication 64859006 DOID:11476
Diabetes mellitus contraindication 73211009 DOID:9351
Hypopituitarism contraindication 74728003 DOID:9406
Angina pectoris contraindication 194828000
Osteopenia contraindication 312894000
Primary adrenocortical insufficiency contraindication 373662000
Disorder of coronary artery contraindication 414024009




🐶 Veterinary Drug Use

SpeciesUseRelation
Dogs Replacement therapy for diminished thyroid function Indication

🐶 Veterinary products

ProductApplicantIngredients
Thyro-Tabs Canine Lloyd Inc. 1
ThyroKare Neogen Corp. 1

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.08 acidic
pKa2 6.63 acidic
pKa3 8.6 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium LEVOXYL KING PHARMS N021301 May 25, 2001 RX TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** LEVOXYL KING PHARMS N021301 May 25, 2001 DISCN TABLET ORAL 7101569 Oct. 2, 2023 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Thyroid hormone receptor alpha Nuclear hormone receptor AGONIST EC50 7.72 CHEMBL IUPHAR
Thyroid hormone receptor beta Nuclear hormone receptor AGONIST IC50 8.52 IUPHAR CHEMBL
Transthyretin Secreted IC50 4.98 CHEMBL
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor Kd 6.40 CHEMBL
Retinoic acid receptor RXR-alpha Nuclear hormone receptor Kd 6.03 CHEMBL
Bile acid receptor Nuclear hormone receptor IC50 5.10 CHEMBL
THAP domain-containing protein 1 Unclassified WOMBAT-PK
Macrophage migration inhibitory factor Unclassified IC50 4.80 CHEMBL
Malate dehydrogenase, mitochondrial Enzyme IC50 4.36 CHEMBL
Thyroid hormone receptor beta Transcription factor IC50 7.46 CHEMBL

External reference:

IDSource
4017826 VUID
N0000179290 NUI
D01010 KEGG_DRUG
55-03-8 SECONDARY_CAS_RN
6106-07-6 SECONDARY_CAS_RN
4017826 VANDF
4022126 VANDF
CHEBI:18332 CHEBI
CHEMBL1624 ChEMBL_ID
CHEMBL2103741 ChEMBL_ID
CHEMBL559 ChEMBL_ID
CHEMBL42115 ChEMBL_ID
DB00451 DRUGBANK_ID
10582 RXNORM
1842 MMSL
4976 MMSL
d00278 MMSL
002132 NDDF
004881 NDDF
005896 NDDF
126202002 SNOMEDCT_US
38076006 SNOMEDCT_US
710809001 SNOMEDCT_US
73187006 SNOMEDCT_US
768532006 SNOMEDCT_US
783637002 SNOMEDCT_US
C0040165 UMLSCUI
D013974 MESH_DESCRIPTOR_UI
T44 PDB_CHEM_ID
453 INN_ID
5819 PUBCHEM_CID
Q51BO43MG4 UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-3727 TABLET 137 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-3727 TABLET 137 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-3727 TABLET 137 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4341 TABLET 25 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4341 TABLET 25 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4341 TABLET 25 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4552 TABLET 50 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4552 TABLET 50 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4552 TABLET 50 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-5182 TABLET 75 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-5182 TABLET 75 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-5182 TABLET 75 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6594 TABLET 88 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6594 TABLET 88 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6594 TABLET 88 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6624 TABLET 100 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6624 TABLET 100 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6624 TABLET 100 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7068 TABLET 125 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7068 TABLET 125 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7068 TABLET 125 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7069 TABLET 150 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7069 TABLET 150 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7069 TABLET 150 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7070 TABLET 175 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7070 TABLET 175 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7070 TABLET 175 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7148 TABLET 200 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7148 TABLET 200 ug ORAL NDA 26 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7148 TABLET 200 ug ORAL NDA 26 sections