levothyroxine 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: 3.51
  • 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 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 ┬ÁM/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
Blood thyroid stimulating hormone increased 861.22 10.31 652 567841 5217 46112352
Hypothyroidism 754.64 10.31 1363 567130 29975 46087594
Rheumatoid arthritis 542.79 10.31 1338 567155 238877 45878692
Drug ineffective 480.82 10.31 5618 562875 672220 45445349
Drug hypersensitivity 479.03 10.31 1454 567039 242371 45875198
Pemphigus 468.56 10.31 19 568474 45255 46072314
Treatment failure 457.06 10.31 284 568209 92803 46024766
Completed suicide 368.92 10.31 764 567729 145156 45972413
Toxicity to various agents 366.81 10.31 1334 567159 210432 45907137
Blood thyroid stimulating hormone abnormal 348.54 10.31 169 568324 513 46117056
Contraindicated product administered 342.53 10.31 282 568211 79665 46037904
Blood thyroid stimulating hormone decreased 271.45 10.31 287 568206 3702 46113867
Systemic lupus erythematosus 270.52 10.31 237 568256 64943 46052626
Off label use 245.66 10.31 3207 565286 376634 45740935
Hyperthyroidism 235.64 10.31 472 568021 11239 46106330
Maternal exposure during pregnancy 232.12 10.31 570 567923 101979 46015590
Thyroid function test abnormal 214.50 10.31 229 568264 2989 46114580
Drug intolerance 209.77 10.31 998 567495 146051 45971518
Exposure during pregnancy 208.75 10.31 650 567843 107562 46010007
Drug abuse 196.38 10.31 292 568201 63116 46054453
Blood thyroid stimulating hormone normal 193.53 10.31 71 568422 73 46117496
Glossodynia 193.15 10.31 154 568339 44219 46073350
Death 191.57 10.31 2904 565589 332644 45784925
Anti-cyclic citrullinated peptide antibody positive 171.66 10.31 17 568476 19128 46098441
Infusion related reaction 169.44 10.31 646 567847 100562 46017007
Rheumatoid factor positive 164.44 10.31 26 568467 20435 46097134
Febrile neutropenia 161.66 10.31 599 567894 94028 46023541
Synovitis 157.40 10.31 316 568177 60759 46056810
Hand deformity 155.56 10.31 116 568377 34458 46083111
Intentional overdose 133.20 10.31 379 568114 64565 46053004
Thyroid disorder 125.98 10.31 378 568115 11698 46105871
Fall 124.99 10.31 5045 563448 324052 45793517
Product substitution issue 119.51 10.31 429 568064 14602 46102967
Therapeutic product effect decreased 111.71 10.31 571 567922 82030 46035539
Myalgia 110.10 10.31 2108 566385 120980 45996589
Asthenia 109.05 10.31 4729 563764 306346 45811223
Cardio-respiratory arrest 104.84 10.31 375 568118 59494 46058075
Drug resistance 103.25 10.31 41 568452 17327 46100242
Dizziness 102.35 10.31 5096 563397 335318 45782251
Palpitations 102.11 10.31 1679 566814 93580 46023989
Hepatic function abnormal 98.52 10.31 167 568326 34254 46083315
Cytomegalovirus infection 96.67 10.31 50 568443 18094 46099475
Muscle spasms 93.48 10.31 2058 566435 121055 45996514
Pericarditis 87.71 10.31 97 568396 23830 46093739
Transplant rejection 84.79 10.31 9 568484 9587 46107982
Arthropathy 82.81 10.31 647 567846 84053 46033516
Thyroid cancer 82.48 10.31 160 568333 3718 46113851
Lower respiratory tract infection 80.75 10.31 370 568123 54719 46062850
Product prescribing error 78.81 10.31 465 568028 19582 46097987
Neutropenia 78.19 10.31 1249 567244 141955 45975614
Therapeutic product effect incomplete 76.40 10.31 597 567896 77556 46040013
Bone marrow failure 76 10.31 154 568339 29515 46088054
Fatigue 74.78 10.31 8482 560011 600215 45517354
Joint swelling 74.38 10.31 1500 566993 164573 45952996
Vertigo 72.91 10.31 961 567532 51087 46066482
Cardiac arrest 72.73 10.31 726 567767 89673 46027896
Feeling abnormal 72.62 10.31 2016 566477 123044 45994525
Infective pulmonary exacerbation of cystic fibrosis 72.07 10.31 21 568472 10786 46106783
Product use in unapproved indication 69.74 10.31 732 567761 89541 46028028
Product complaint 69.43 10.31 312 568181 11789 46105780
Abdominal discomfort 69.29 10.31 1360 567133 149805 45967764
Respiratory arrest 67.38 10.31 200 568293 33616 46083953
Red blood cell sedimentation rate abnormal 66.44 10.31 42 568451 13607 46103962
Pyrexia 65.89 10.31 3524 564969 345278 45772291
Product use issue 64.64 10.31 789 567704 93855 46023714
Duodenal ulcer perforation 63.56 10.31 13 568480 8489 46109080
Balance disorder 62.51 10.31 1119 567374 63402 46054167
Atrial fibrillation 61.56 10.31 1675 566818 101915 46015654
Product formulation issue 61.53 10.31 57 568436 619 46116950
Weight increased 60.54 10.31 2514 565979 161959 45955610
Autoimmune thyroiditis 59.32 10.31 119 568374 2836 46114733
Dysgeusia 58.97 10.31 753 567740 39738 46077831
Craniopharyngioma 57.65 10.31 31 568462 124 46117445
Septic shock 56.68 10.31 442 568051 57451 46060118
Toxic epidermal necrolysis 55.91 10.31 117 568376 22161 46095408
Disturbance in attention 55.72 10.31 609 567884 30951 46086618
Pain 55.11 10.31 5030 563463 471918 45645651
Hyponatraemia 55.07 10.31 1620 566873 99712 46017857
C-reactive protein abnormal 54.82 10.31 110 568383 21160 46096409
Overdose 54.46 10.31 893 567600 101086 46016483
Wound 54.44 10.31 302 568191 42500 46075069
Adrenocortical insufficiency acute 54.15 10.31 73 568420 1233 46116336
Infection 53.58 10.31 1228 567265 132364 45985205
Therapeutic response unexpected 53.10 10.31 349 568144 15267 46102302
Hepatic enzyme increased 51.69 10.31 693 567800 81094 46036475
Dry mouth 51.58 10.31 948 567545 53978 46063591
Pregnancy 50.19 10.31 166 568327 26971 46090598
Device expulsion 49.89 10.31 170 568323 27372 46090197
Multiple organ dysfunction syndrome 47.77 10.31 401 568092 51309 46066260
Mucosal inflammation 46.89 10.31 280 568213 38696 46078873
Suicide attempt 45.93 10.31 438 568055 54598 46062971
Haemophagocytic lymphohistiocytosis 45.93 10.31 22 568471 8320 46109249
Pathogen resistance 45.86 10.31 9 568484 6051 46111518
Reaction to excipient 45.58 10.31 63 568430 1091 46116478
Thyroidectomy 45.52 10.31 57 568436 892 46116677
Anaphylactic reaction 45.48 10.31 420 568073 52692 46064877
Vision blurred 45.42 10.31 1282 567211 78426 46039143
Syncope 45.41 10.31 1631 566862 103172 46014397
Disease progression 44.71 10.31 812 567681 90488 46027081
Accidental exposure to product 43.22 10.31 123 568370 20958 46096611
Myxoedema coma 41.72 10.31 37 568456 378 46117191
Insulin-like growth factor increased 41.25 10.31 49 568444 724 46116845
Tri-iodothyronine decreased 40.98 10.31 23 568470 102 46117467
Thyroxine free increased 40.17 10.31 48 568445 714 46116855
Insomnia 40.11 10.31 2422 566071 162502 45955067
Abortion spontaneous 40.07 10.31 339 568154 43307 46074262
Transplant dysfunction 39.85 10.31 5 568488 4677 46112892
Device difficult to use 39.84 10.31 24 568469 7980 46109589
Visual impairment 39.51 10.31 1078 567415 65611 46051958
Sepsis 39.12 10.31 1310 567183 134704 45982865
Musculoskeletal stiffness 38.93 10.31 902 567591 97091 46020478
Swelling 38.00 10.31 1190 567303 123321 45994248
Diffuse alopecia 37.59 10.31 40 568453 520 46117049
Stillbirth 37.49 10.31 16 568477 6475 46111094
Tremor 37.30 10.31 1744 566749 113895 46003674
Hepatotoxicity 37.22 10.31 167 568326 24842 46092727
Neurotoxicity 37.04 10.31 69 568424 13648 46103921
Thyroxine increased 37.00 10.31 39 568454 501 46117068
Nervousness 36.29 10.31 517 567976 27958 46089611
Rash 36.03 10.31 3796 564697 352716 45764853
Disseminated intravascular coagulation 36.01 10.31 115 568378 18890 46098679
Hot flush 35.74 10.31 736 567757 42781 46074788
Dysphagia 35.43 10.31 1211 567282 76101 46041468
Venoocclusive liver disease 35.08 10.31 5 568488 4246 46113323
Constipation 35.02 10.31 2516 565977 171581 45945988
Pneumonia 34.35 10.31 4035 564458 372285 45745284
Pituitary tumour recurrent 34.28 10.31 17 568476 55 46117514
Thyroxine abnormal 34.20 10.31 10 568483 0 46117569
Coma 34.16 10.31 502 567991 57847 46059722
Neutrophil count decreased 33.98 10.31 351 568142 43075 46074494
Unintentional medical device removal 33.96 10.31 7 568486 4546 46113023
Thyroid hormones increased 33.95 10.31 27 568466 234 46117335
Hyperhidrosis 33.94 10.31 1370 567123 87938 46029631
Product quality issue 33.72 10.31 616 567877 35032 46082537
Cerebral haematoma 33.40 10.31 103 568390 3236 46114333
Blood cholesterol increased 33.28 10.31 678 567815 39335 46078234
Oral pain 33.13 10.31 454 568039 24343 46093226
Exophthalmos 33.06 10.31 54 568439 1091 46116478
Weight decreased 33.01 10.31 2989 565504 207860 45909709
Oedema peripheral 32.98 10.31 2313 566180 157393 45960176
Papillitis 32.87 10.31 12 568481 12 46117557
Intentional self-injury 32.11 10.31 168 568325 23998 46093571
Therapy non-responder 32.04 10.31 333 568160 40819 46076750
Product odour abnormal 32.03 10.31 53 568440 1083 46116486
Transient ischaemic attack 31.93 10.31 600 567893 34303 46083266
Amnesia 31.89 10.31 697 567796 40934 46076635
Product measured potency issue 31.89 10.31 20 568473 113 46117456
Haematotoxicity 31.52 10.31 23 568470 6910 46110659
Premature baby 31.33 10.31 114 568379 17998 46099571
Pneumocystis jirovecii pneumonia 31.24 10.31 89 568404 15159 46102410
Thrombotic microangiopathy 31.19 10.31 33 568460 8273 46109296
Gait disturbance 31.07 10.31 2110 566383 143153 45974416
Product monitoring error 30.86 10.31 72 568421 1909 46115660
General physical health deterioration 30.79 10.31 1714 566779 114055 46003514
Myxoedema 30.44 10.31 20 568473 124 46117445
Abortion induced 30.08 10.31 49 568444 10211 46107358
Therapeutic response decreased 30.08 10.31 358 568135 42787 46074782
No adverse event 30.04 10.31 269 568224 33962 46083607
Helicobacter infection 29.98 10.31 61 568432 11675 46105894
Myelosuppression 29.60 10.31 30 568463 7673 46109896
Hypersensitivity 29.55 10.31 1512 566981 148809 45968760
Premature labour 29.49 10.31 58 568435 11241 46106328
Blood calcium decreased 29.32 10.31 306 568187 15367 46102202
Flatulence 29.08 10.31 504 567989 28374 46089195
Panniculitis 28.53 10.31 17 568476 5687 46111882
Dry skin 28.40 10.31 677 567816 40339 46077230
Blood thyroid stimulating hormone 28.35 10.31 11 568482 15 46117554
Premature delivery 27.90 10.31 156 568337 21913 46095656
Condition aggravated 27.66 10.31 2588 565905 242464 45875105
Juvenile idiopathic arthritis 27.61 10.31 8 568485 4124 46113445
Foetal death 27.31 10.31 40 568453 8703 46108866
Swollen tongue 27.25 10.31 504 567989 28728 46088841
Papillary thyroid cancer 27.19 10.31 69 568424 1932 46115637
Thrombocytopenia 27.07 10.31 1262 567231 125319 45992250
Pulmonary tuberculosis 26.79 10.31 12 568481 4719 46112850
Joint destruction 26.75 10.31 3 568490 3061 46114508
Milk-alkali syndrome 26.73 10.31 35 568458 574 46116995
Muscular weakness 26.65 10.31 1371 567122 90473 46027096
Post transplant lymphoproliferative disorder 26.63 10.31 7 568486 3849 46113720
Jaw disorder 26.30 10.31 128 568365 5002 46112567
Sickle cell anaemia with crisis 26.18 10.31 8 568485 3984 46113585
Drug dependence 26.08 10.31 139 568354 19762 46097807
Blood glucose increased 26.06 10.31 1099 567394 70914 46046655
Therapeutic drug monitoring analysis not performed 26.05 10.31 31 568462 459 46117110
Hypersomnia 25.92 10.31 295 568198 15144 46102425
Lactose intolerance 25.69 10.31 76 568417 2333 46115236
Rheumatoid nodule 25.59 10.31 44 568449 8976 46108593
Thyroxine decreased 25.42 10.31 30 568463 440 46117129
Dyspepsia 25.24 10.31 1047 567446 67425 46050144
Arrhythmia 25.02 10.31 578 567915 34263 46083306
Product taste abnormal 24.94 10.31 66 568427 1897 46115672
Small for dates baby 24.93 10.31 99 568394 3538 46114031
Exposure via ingestion 24.51 10.31 6 568487 3461 46114108
Scleral discolouration 24.37 10.31 26 568467 339 46117230
Orthostatic hypotension 24.35 10.31 429 568064 24229 46093340
Presbyacusis 24.05 10.31 3 568490 2819 46114750
Extremity contracture 24.01 10.31 48 568445 1141 46116428
Seizure 23.94 10.31 1239 567254 121815 45995754
Dysphonia 23.90 10.31 625 567868 37789 46079780
Lymphocyte count decreased 23.83 10.31 198 568295 25391 46092178
Renal dysplasia 23.67 10.31 18 568475 145 46117424
Acute respiratory distress syndrome 23.55 10.31 163 568330 21759 46095810
Enthesopathy 23.43 10.31 14 568479 4676 46112893
Ageusia 23.40 10.31 228 568265 11244 46106325
Hypoacusis 23.34 10.31 372 568121 20597 46096972
Soft tissue disorder 23.32 10.31 107 568386 4079 46113490
Thyrotoxic periodic paralysis 23.30 10.31 9 568484 12 46117557
Pneumonia aspiration 23.29 10.31 259 568234 31346 46086223
Epstein-Barr virus infection 23.25 10.31 29 568464 6755 46110814
Headache 23.15 10.31 6349 562144 472003 45645566
Goitre 23.15 10.31 127 568366 5204 46112365
Pneumonia viral 23.11 10.31 149 568344 6475 46111094
Product solubility abnormal 23.02 10.31 39 568454 813 46116756
Poisoning 22.96 10.31 90 568403 13904 46103665
Discomfort 22.86 10.31 415 568078 46255 46071314
Graft versus host disease 22.75 10.31 28 568465 6560 46111009
Head discomfort 22.74 10.31 209 568284 10142 46107427
Malaise 22.48 10.31 4465 564028 326767 45790802
Respiratory failure 22.39 10.31 935 567558 93881 46023688
Interstitial lung disease 22.14 10.31 494 567999 53455 46064114
Somatic delusion 22.04 10.31 32 568461 581 46116988
Product colour issue 21.99 10.31 33 568460 618 46116951
Pancytopenia 21.98 10.31 830 567663 84228 46033341
C-reactive protein increased 21.96 10.31 544 567949 58046 46059523
Adenovirus infection 21.85 10.31 4 568489 2826 46114743
Pituitary tumour benign 21.85 10.31 57 568436 1624 46115945
Peritonitis 21.77 10.31 155 568338 20559 46097010
Eye irritation 21.71 10.31 303 568190 16311 46101258
Cystitis haemorrhagic 21.70 10.31 8 568485 3539 46114030
Injection site pain 21.59 10.31 1075 567418 106077 46011492
Blood iron abnormal 21.43 10.31 6 568487 3164 46114405
Hip arthroplasty 21.32 10.31 131 568362 17981 46099588
Rapid eye movement sleep behaviour disorder 21.31 10.31 17 568476 148 46117421
Thyroxine free decreased 21.21 10.31 28 568465 463 46117106
Multiple-drug resistance 21.21 10.31 3 568490 2562 46115007
Drug level changed 21.04 10.31 17 568476 151 46117418
Insulin-like growth factor decreased 21.02 10.31 25 568468 370 46117199
Ankylosing spondylitis 20.87 10.31 31 568462 6706 46110863
Bronchopulmonary aspergillosis 20.87 10.31 37 568456 7459 46110110
Pulmonary malformation 20.79 10.31 14 568479 91 46117478
Asthma 20.72 10.31 907 567586 90635 46026934
Adenomatous polyposis coli 20.71 10.31 10 568483 30 46117539
Impaired driving ability 20.66 10.31 104 568389 4120 46113449
Atrioventricular block 20.65 10.31 148 568345 6663 46110906
Contusion 20.35 10.31 1280 567213 86207 46031362
Posterior reversible encephalopathy syndrome 20.26 10.31 105 568388 15036 46102533
Body height decreased 20.26 10.31 193 568300 9459 46108110
Metastases to bone 20.26 10.31 127 568366 17349 46100220
Alopecia 20.25 10.31 1702 566791 160712 45956857
Cushingoid 20.23 10.31 28 568465 6238 46111331
Gastrointestinal toxicity 20.17 10.31 14 568479 4317 46113252
Cytomegalovirus viraemia 20.17 10.31 15 568478 4463 46113106
Memory impairment 20.16 10.31 1143 567350 76194 46041375
Injection site swelling 19.94 10.31 358 568135 39969 46077600
Cystic fibrosis 19.89 10.31 10 568483 3678 46113891
Recalled product 19.80 10.31 45 568448 1172 46116397
Feeling cold 19.77 10.31 330 568163 18441 46099128
Hospitalisation 19.76 10.31 604 567889 62781 46054788
Acute graft versus host disease in skin 19.51 10.31 6 568487 2976 46114593
Incorrect dose administered 19.50 10.31 708 567785 44842 46072727
Sedation complication 19.45 10.31 92 568401 3553 46114016
Bone erosion 19.43 10.31 55 568438 9388 46108181
Device adhesion issue 19.42 10.31 3 568490 2399 46115170
Swollen joint count increased 19.40 10.31 3 568490 2397 46115172
Autoimmune hepatitis 19.36 10.31 162 568331 7652 46109917
Trichorrhexis 19.35 10.31 41 568452 1017 46116552
Tri-iodothyronine increased 19.31 10.31 14 568479 104 46117465
Aplastic anaemia 19.30 10.31 36 568457 7117 46110452
Tenosynovitis 19.25 10.31 39 568454 7476 46110093
Insulin autoimmune syndrome 19.22 10.31 11 568482 51 46117518
Low turnover osteopathy 19.18 10.31 103 568390 4186 46113383
Graft versus host disease in skin 19.04 10.31 3 568490 2364 46115205
Therapeutic product effect increased 18.93 10.31 40 568453 990 46116579
Hypophysitis 18.89 10.31 48 568445 1345 46116224
Limb deformity 18.83 10.31 10 568483 3566 46114003
Chronic graft versus host disease 18.72 10.31 5 568488 2720 46114849
Thyrotoxic crisis 18.69 10.31 33 568460 712 46116857
Blood pressure increased 18.64 10.31 1788 566705 124878 45992691
Gestational diabetes 18.60 10.31 151 568342 7068 46110501
Pituitary tumour 18.55 10.31 37 568456 878 46116691
Drug tolerance decreased 18.55 10.31 7 568486 3052 46114517
Drug reaction with eosinophilia and systemic symptoms 18.43 10.31 251 568242 29297 46088272
Thyroid cancer recurrent 18.40 10.31 9 568484 28 46117541
Haematochezia 18.37 10.31 592 567901 36901 46080668
Eye swelling 18.18 10.31 345 568148 19758 46097811
Blood parathyroid hormone decreased 18.08 10.31 16 568477 4365 46113204
Listless 17.84 10.31 60 568433 1975 46115594
Pharyngitis 17.79 10.31 133 568360 17450 46100119
Cognitive disorder 17.72 10.31 581 567912 36302 46081267
Gastrointestinal motility disorder 17.68 10.31 104 568389 4374 46113195
Blood creatine abnormal 17.57 10.31 13 568480 100 46117469
Congenital renal cyst 17.51 10.31 6 568487 4 46117565
Thyroxine free abnormal 17.51 10.31 6 568487 4 46117565
Substance abuse 17.46 10.31 15 568478 4152 46113417
Tinnitus 17.44 10.31 451 568042 27222 46090347
Hypopituitarism 17.41 10.31 32 568461 713 46116856
Blood glucose decreased 17.36 10.31 325 568168 18567 46099002
Pleural fibrosis 17.35 10.31 11 568482 3558 46114011
Injection site reaction 17.20 10.31 447 568046 47402 46070167
Muscle fatigue 17.16 10.31 63 568430 2168 46115401
Inner ear disorder 17.02 10.31 25 568468 459 46117110
Endocrine ophthalmopathy 16.99 10.31 19 568474 262 46117307
Injection site pruritus 16.86 10.31 362 568131 39381 46078188
Tooth fracture 16.76 10.31 182 568311 9233 46108336
Confusional state 16.70 10.31 2207 566286 157685 45959884
Nasopharyngitis 16.70 10.31 1631 566862 152367 45965202
Knee arthroplasty 16.63 10.31 196 568297 23469 46094100
Hypoglycaemia 16.52 10.31 815 567678 53534 46064035
Therapeutic product effect variable 16.48 10.31 39 568454 1044 46116525
Oral discomfort 16.46 10.31 158 568335 7760 46109809
Frontotemporal dementia 16.39 10.31 18 568475 243 46117326
Metastatic bronchial carcinoma 16.31 10.31 13 568480 113 46117456
Erythema dyschromicum perstans 16.30 10.31 10 568483 54 46117515
Tuberculosis 16.22 10.31 67 568426 10198 46107371
Skin ulcer 16.09 10.31 288 568205 32170 46085399
Muscle spasticity 16.07 10.31 78 568415 11362 46106207
Traumatic ulcer 16.02 10.31 9 568484 40 46117529
Cardiac pacemaker insertion 15.98 10.31 88 568405 3611 46113958
Madarosis 15.96 10.31 53 568440 1733 46115836
Hair texture abnormal 15.91 10.31 73 568420 2783 46114786
Suspected suicide 15.90 10.31 20 568473 4641 46112928
Creatinine renal clearance decreased 15.85 10.31 141 568352 6779 46110790
Aspergillus infection 15.80 10.31 38 568455 6852 46110717
Pelvic fracture 15.71 10.31 212 568281 11327 46106242
Intentional product use issue 15.71 10.31 506 567987 52274 46065295
Blood growth hormone abnormal 15.67 10.31 8 568485 28 46117541
Cerebellar haematoma 15.65 10.31 21 568472 353 46117216
Diarrhoea 15.56 10.31 7277 561216 552325 45565244
Lymphadenectomy 15.56 10.31 34 568459 862 46116707
Coronary artery occlusion 15.54 10.31 159 568334 7943 46109626
Bundle branch block left 15.50 10.31 132 568361 6267 46111302
Skin toxicity 15.50 10.31 13 568480 3641 46113928
Pancreatic neuroendocrine tumour 15.48 10.31 19 568474 291 46117278
Cardiotoxicity 15.48 10.31 37 568456 6685 46110884
Dry eye 15.44 10.31 481 568012 29841 46087728
Bradycardia 15.42 10.31 970 567523 65328 46052241
Disease recurrence 15.40 10.31 147 568346 18324 46099245
Live birth 15.36 10.31 69 568424 10261 46107308
Injection site erythema 15.31 10.31 745 567748 73682 46043887
Cataract 15.29 10.31 688 567805 44727 46072842
Device related infection 15.28 10.31 173 568320 20868 46096701
Immune reconstitution inflammatory syndrome 15.28 10.31 29 568464 5696 46111873
Tongue discomfort 15.23 10.31 52 568441 1725 46115844
Glomerular filtration rate decreased 15.17 10.31 213 568280 11481 46106088
Abnormal weight gain 15.17 10.31 46 568447 1432 46116137
Thyroid hormones decreased 15.15 10.31 15 568478 178 46117391
Device use error 15.14 10.31 24 568469 5057 46112512
Ecchymosis 15.10 10.31 196 568297 10380 46107189
Bone pain 15.07 10.31 707 567786 46183 46071386
Dehydration 15.05 10.31 2189 566304 157351 45960218
Gastrointestinal disorder 15.02 10.31 583 567910 58993 46058576
Lung cyst 15.00 10.31 12 568481 105 46117464
Respiratory disorder 14.91 10.31 238 568255 27062 46090507
Product physical issue 14.90 10.31 107 568386 4820 46112749
Diverticulum 14.90 10.31 205 568288 11001 46106568
Product dispensing error 14.86 10.31 175 568318 9058 46108511
Unintended pregnancy 14.82 10.31 29 568464 5631 46111938
Anaemia postoperative 14.73 10.31 59 568434 2117 46115452
Labile hypertension 14.73 10.31 24 568469 484 46117085
Hair growth abnormal 14.71 10.31 66 568427 2492 46115077
Ventricular hypertrophy 14.69 10.31 88 568405 3726 46113843
Swelling face 14.57 10.31 788 567705 52271 46065298
Oropharyngeal swelling 14.56 10.31 33 568460 858 46116711
Sleep disorder due to general medical condition, insomnia type 14.53 10.31 26 568467 5223 46112346
Rectourethral fistula 14.51 10.31 8 568485 34 46117535
Thyroid cancer metastatic 14.49 10.31 13 568480 135 46117434
Disability 14.47 10.31 69 568424 10098 46107471
Malabsorption 14.39 10.31 87 568406 3696 46113873
Thyroid atrophy 14.26 10.31 7 568486 22 46117547
Liver disorder 14.18 10.31 345 568148 36901 46080668
Neuromyopathy 14.18 10.31 24 568469 500 46117069
Adenoiditis 14.16 10.31 8 568485 36 46117533
Pain in extremity 14.12 10.31 3452 565041 255228 45862341
Hypogammaglobulinaemia 14.12 10.31 28 568465 5410 46112159
Acute lymphocytic leukaemia recurrent 14.10 10.31 4 568489 2091 46115478
Drug eruption 14.10 10.31 179 568314 21150 46096419
Febrile bone marrow aplasia 14.09 10.31 40 568453 6822 46110747
Choking 14.04 10.31 160 568333 8216 46109353
Complications of transplanted kidney 14.02 10.31 5 568488 2258 46115311
Hip fracture 13.99 10.31 423 568070 26133 46091436
Temperature intolerance 13.99 10.31 148 568345 7459 46110110
Paraesthesia 13.94 10.31 1634 566859 115803 46001766
Shock 13.83 10.31 185 568308 21660 46095909
Spondylolisthesis 13.82 10.31 74 568419 3004 46114565
Blood magnesium increased 13.82 10.31 10 568483 3017 46114552
Arterial occlusive disease 13.77 10.31 103 568390 4701 46112868
Hepatic failure 13.71 10.31 306 568187 33110 46084459
Blood loss anaemia 13.69 10.31 162 568331 8395 46109174
Deformity 13.69 10.31 44 568449 7213 46110356
Neonatal thyrotoxicosis 13.68 10.31 4 568489 0 46117569
Hypotensive transfusion reaction 13.67 10.31 8 568485 39 46117530
Follicular thyroid cancer 13.67 10.31 9 568484 56 46117513
Product administration error 13.67 10.31 325 568168 19356 46098213
Melanoma recurrent 13.61 10.31 10 568483 76 46117493
Status epilepticus 13.55 10.31 107 568386 13872 46103697
Aortic intramural haematoma 13.55 10.31 9 568484 57 46117512
Vitello-intestinal duct remnant 13.52 10.31 8 568485 40 46117529
Lymphoproliferative disorder 13.50 10.31 8 568485 2684 46114885
Decreased appetite 13.43 10.31 2616 565877 191220 45926349
Hypertension 13.40 10.31 2648 565845 193708 45923861
Product coating issue 13.36 10.31 8 568485 41 46117528
Body height below normal 13.36 10.31 3 568490 1836 46115733
Amniotic fluid volume increased 13.28 10.31 13 568480 152 46117417
Gingival disorder 13.27 10.31 76 568417 3165 46114404
Anxiety 13.27 10.31 2462 566031 179495 45938074
Thinking abnormal 13.24 10.31 180 568313 9634 46107935
Metabolic acidosis 13.23 10.31 365 568128 38415 46079154
Acute hepatic failure 13.21 10.31 115 568378 14606 46102963
Magnetic resonance imaging thoracic abnormal 13.21 10.31 7 568486 27 46117542
Gastritis 13.20 10.31 528 567965 33850 46083719
Carcinoid tumour of the stomach 13.15 10.31 13 568480 154 46117415
Genital swelling 13.12 10.31 12 568481 128 46117441
Mydriasis 13.12 10.31 75 568418 10478 46107091
Neck injury 13.07 10.31 48 568445 1652 46115917
Upper respiratory tract inflammation 13.06 10.31 9 568484 2786 46114783
Neutropenic sepsis 13.06 10.31 92 568401 12232 46105337
Blood insulin increased 12.99 10.31 11 568482 105 46117464
Neonatal tachypnoea 12.95 10.31 9 568484 62 46117507
Agranulocytosis 12.93 10.31 191 568302 21994 46095575
Altered state of consciousness 12.93 10.31 203 568290 23145 46094424
Ophthalmic vein thrombosis 12.91 10.31 12 568481 131 46117438
Feeling jittery 12.90 10.31 197 568296 10811 46106758
Anti-thyroid antibody positive 12.87 10.31 21 568472 424 46117145
Gastrooesophageal reflux disease 12.87 10.31 1062 567431 73282 46044287
Nephropathy toxic 12.84 10.31 47 568446 7407 46110162
Persistent depressive disorder 12.83 10.31 34 568459 978 46116591
Urine sodium decreased 12.83 10.31 13 568480 159 46117410
Malignant neoplasm progression 12.75 10.31 653 567840 64273 46053296
Product residue present 12.74 10.31 86 568407 3796 46113773
Anosmia 12.72 10.31 87 568406 3857 46113712
Haemorrhoids 12.71 10.31 309 568184 18468 46099101
Kidney transplant rejection 12.71 10.31 19 568474 4099 46113470
International normalised ratio abnormal 12.70 10.31 72 568421 2987 46114582
Electrocardiogram change 12.68 10.31 25 568468 588 46116981
Supraventricular extrasystoles 12.68 10.31 90 568403 4039 46113530
Blood growth hormone increased 12.68 10.31 20 568473 392 46117177
Red blood cell sedimentation rate 12.67 10.31 3 568490 1770 46115799
Dilatation atrial 12.66 10.31 56 568437 2101 46115468
Dysstasia 12.65 10.31 293 568200 17375 46100194
Basedow's disease 12.64 10.31 18 568475 321 46117248
Varicose vein 12.64 10.31 95 568398 4343 46113226
Eye pain 12.63 10.31 437 568056 27503 46090066
Body height increased 12.61 10.31 9 568484 65 46117504
Foreign body in reproductive tract 12.61 10.31 16 568477 254 46117315
Vomiting 12.59 10.31 5147 563346 447647 45669922
Impatience 12.55 10.31 18 568475 323 46117246
Granulocytopenia 12.37 10.31 108 568385 5165 46112404
Labyrinthitis 12.36 10.31 54 568439 2015 46115554
Pseudomonas infection 12.32 10.31 69 568424 9689 46107880
Parathyroid gland enlargement 12.31 10.31 7 568486 32 46117537
Psychomotor skills impaired 12.27 10.31 56 568437 2130 46115439
BK virus infection 12.25 10.31 10 568483 2839 46114730
Lupus nephritis 12.25 10.31 6 568487 2240 46115329
Graft versus host disease in gastrointestinal tract 12.20 10.31 8 568485 2542 46115027
Incorrect route of product administration 12.17 10.31 134 568359 16249 46101320
Peritoneal dialysis complication 12.17 10.31 9 568484 2685 46114884
Product packaging issue 12.16 10.31 33 568460 963 46116606
Angina pectoris 12.16 10.31 419 568074 26356 46091213
Disorientation 12.15 10.31 558 567935 36360 46081209
Acute myeloid leukaemia 12.15 10.31 128 568365 15650 46101919
Folliculitis 12.13 10.31 37 568456 6166 46111403
Coombs positive haemolytic anaemia 12.09 10.31 19 568474 371 46117198
Lenticular opacities 12.09 10.31 14 568479 201 46117368
Barrett's oesophagus 12.08 10.31 26 568467 652 46116917
Retinal artery embolism 11.99 10.31 9 568484 71 46117498
Metastases to liver 11.99 10.31 167 568326 19418 46098151
Osteonecrosis of jaw 11.94 10.31 323 568170 34079 46083490
Hyperlipidaemia 11.93 10.31 303 568190 18236 46099333
Nausea 11.90 10.31 8818 559675 678636 45438933
Blood calcium increased 11.86 10.31 143 568350 7444 46110125
Metastatic renal cell carcinoma 11.85 10.31 32 568461 931 46116638
Vessel puncture site haemorrhage 11.85 10.31 10 568483 95 46117474
Trance 11.83 10.31 7 568486 35 46117534
Application site erythema 11.80 10.31 101 568392 4803 46112766
Transcription medication error 11.75 10.31 13 568480 177 46117392
Hypertensive crisis 11.75 10.31 232 568261 13383 46104186
Hepatojugular reflux 11.73 10.31 5 568488 10 46117559
Electrocardiogram ST-T segment abnormal 11.73 10.31 15 568478 240 46117329
Lip swelling 11.68 10.31 398 568095 24997 46092572
Congenital hydronephrosis 11.63 10.31 19 568474 384 46117185
Sprue-like enteropathy 11.60 10.31 20 568473 423 46117146
Carotid artery stenosis 11.56 10.31 104 568389 5016 46112553
Intervertebral disc protrusion 11.56 10.31 328 568165 20077 46097492
Renal tubular necrosis 11.55 10.31 80 568413 10679 46106890
Cytokine release syndrome 11.55 10.31 38 568455 6185 46111384
Open reduction of fracture 11.54 10.31 36 568457 1138 46116431
Vocal cord paresis 11.52 10.31 8 568485 55 46117514
Gastrointestinal tract irritation 11.52 10.31 21 568472 465 46117104
Hyperbilirubinaemia 11.51 10.31 77 568416 10361 46107208
Ilium fracture 11.50 10.31 9 568484 76 46117493
Hypoglycaemic unconsciousness 11.50 10.31 27 568466 719 46116850
Plasma cell myeloma 11.49 10.31 434 568059 44044 46073525
Fasciotomy 11.48 10.31 4 568489 3 46117566
Crohn's disease 11.46 10.31 43 568450 6728 46110841
Dystonia 11.46 10.31 85 568408 11172 46106397
Nephritic syndrome 11.46 10.31 12 568481 153 46117416
Transient global amnesia 11.42 10.31 19 568474 390 46117179
Anal prolapse 11.42 10.31 11 568482 126 46117443
Blood pressure orthostatic decreased 11.41 10.31 8 568485 56 46117513
Muscle discomfort 11.41 10.31 9 568484 77 46117492
Lung lobectomy 11.36 10.31 10 568483 101 46117468
Foetal chromosome abnormality 11.35 10.31 6 568487 23 46117546
Gingival pain 11.34 10.31 119 568374 5984 46111585
Tension 11.31 10.31 67 568426 2825 46114744
Pancreatic neoplasm 11.31 10.31 27 568466 727 46116842
Abnormal dreams 11.30 10.31 182 568311 10097 46107472
Stool analysis abnormal 11.30 10.31 8 568485 57 46117512
Pleural thickening 11.30 10.31 9 568484 2586 46114983
Mean cell haemoglobin concentration increased 11.28 10.31 20 568473 433 46117136
Vein discolouration 11.28 10.31 12 568481 156 46117413
Bone formation increased 11.26 10.31 13 568480 186 46117383
Mucormycosis 11.23 10.31 7 568486 2285 46115284
Supraventricular tachyarrhythmia 11.23 10.31 9 568484 79 46117490
Toxic anterior segment syndrome 11.22 10.31 6 568487 2131 46115438
Growth hormone deficiency 11.21 10.31 11 568482 129 46117440
Deafness transitory 11.20 10.31 3 568490 1629 46115940
Tooth dislocation 11.16 10.31 6 568487 24 46117545
Abnormal faeces 11.15 10.31 86 568407 3963 46113606
Liver function test abnormal 11.15 10.31 682 567811 45805 46071764
Myelodysplastic syndrome 11.09 10.31 130 568363 15581 46101988
Wheezing 11.05 10.31 534 567959 52852 46064717
Forced expiratory volume decreased 11.05 10.31 29 568464 5075 46112494
Mucosal haemorrhage 11.03 10.31 28 568465 784 46116785
Mood altered 11.01 10.31 221 568272 12786 46104783
Psoriatic arthropathy 11.01 10.31 348 568145 36031 46081538
Instillation site pain 11.00 10.31 30 568463 878 46116691
Depression 11.00 10.31 2288 566205 167816 45949753
Endocrine disorder 10.99 10.31 20 568473 442 46117127
Lymph node palpable 10.99 10.31 10 568483 106 46117463
Bacteraemia 10.93 10.31 115 568378 14064 46103505
Gastric pH increased 10.83 10.31 7 568486 42 46117527
Thyroglobulin increased 10.83 10.31 7 568486 42 46117527
Cardiac valve sclerosis 10.80 10.31 6 568487 26 46117543
Hormone level abnormal 10.71 10.31 53 568440 2085 46115484
Idiosyncratic drug reaction 10.70 10.31 28 568465 799 46116770
Postural tremor 10.70 10.31 11 568482 137 46117432
Intramedullary rod insertion 10.65 10.31 53 568440 2090 46115479
Pseudomembranous colitis 10.60 10.31 14 568479 3181 46114388
Poisoning deliberate 10.59 10.31 55 568438 7871 46109698
Blood count abnormal 10.58 10.31 289 568204 17589 46099980
Arrhythmia neonatal 10.57 10.31 8 568485 64 46117505
Aplasia 10.56 10.31 17 568476 3559 46114010
Pancreatic enzymes increased 10.54 10.31 25 568468 670 46116899
Diffuse large B-cell lymphoma 10.52 10.31 37 568456 5901 46111668
Injection site bruising 10.52 10.31 342 568151 35294 46082275
Product packaging confusion 10.52 10.31 11 568482 140 46117429
Peritonitis bacterial 10.49 10.31 62 568431 8591 46108978
Change of bowel habit 10.46 10.31 46 568447 1722 46115847
Narrow anterior chamber angle 10.45 10.31 7 568486 45 46117524
Scar 10.44 10.31 205 568288 11814 46105755
Withdrawal syndrome 10.41 10.31 292 568201 17842 46099727
Tooth disorder 10.41 10.31 364 568129 22939 46094630
Generalised tonic-clonic seizure 10.39 10.31 251 568242 26871 46090698
Blood sodium decreased 10.37 10.31 342 568151 21384 46096185
Congenital acrochordon 10.37 10.31 8 568485 66 46117503
Starvation ketoacidosis 10.37 10.31 8 568485 66 46117503
Hypoglossal nerve paralysis 10.35 10.31 5 568488 15 46117554
Hyperadrenalism 10.35 10.31 5 568488 15 46117554
Congenital absence of vertebra 10.35 10.31 5 568488 15 46117554
Eructation 10.34 10.31 135 568358 7160 46110409
Tooth resorption 10.33 10.31 7 568486 46 46117523

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 529.43 10.20 517 159221 14446 29778294
Blood thyroid stimulating hormone increased 314.97 10.20 194 159544 2662 29790078
Drug abuse 239.81 10.20 70 159668 82002 29710738
Toxicity to various agents 173.29 10.20 435 159303 176748 29615992
Foetal exposure during pregnancy 157.06 10.20 493 159245 36378 29756362
Craniopharyngioma 135.92 10.20 54 159684 256 29792484
Febrile neutropenia 126.54 10.20 235 159503 106458 29686282
Atrial septal defect 120.15 10.20 163 159575 6538 29786202
Drug ineffective 116.88 10.20 1207 158531 339180 29453560
Blood thyroid stimulating hormone decreased 96.09 10.20 79 159659 1748 29790992
Small for dates baby 91.93 10.20 99 159639 3109 29789631
Fatigue 87.18 10.20 2281 157457 318392 29474348
Blood thyroid stimulating hormone abnormal 82.23 10.20 32 159706 142 29792598
Thyroid function test abnormal 82.03 10.20 48 159690 596 29792144
Thyroid disorder 81.74 10.20 86 159652 2628 29790112
Treatment failure 77.83 10.20 44 159694 34635 29758105
Asthenia 71.42 10.20 1612 158126 219678 29573062
Respiratory disorder neonatal 70.21 10.20 55 159683 1133 29791607
Pituitary tumour benign 65.67 10.20 46 159692 793 29791947
Off label use 60.32 10.20 951 158787 248339 29544401
Insulin-like growth factor decreased 59.73 10.20 29 159709 239 29792501
Neutropenia 58.02 10.20 424 159314 128116 29664624
Thyroid cancer 57.54 10.20 51 159687 1254 29791486
Drug resistance 57.25 10.20 18 159720 20115 29772625
Hypopituitarism 54.12 10.20 54 159684 1548 29791192
Pyloric stenosis 52.90 10.20 35 159703 547 29792193
Drug dependence 50.75 10.20 25 159713 21270 29771470
Thyroxine free decreased 49.71 10.20 25 159713 224 29792516
Autoimmune thyroiditis 49.29 10.20 42 159696 978 29791762
Hyperthyroidism 46.87 10.20 121 159617 7977 29784763
Insulin-like growth factor increased 46.53 10.20 41 159697 1000 29791740
Adrenocortical insufficiency acute 45.04 10.20 45 159693 1292 29791448
Completed suicide 44.96 10.20 328 159410 99164 29693576
Thyroxine decreased 44.60 10.20 19 159719 111 29792629
Chronic pigmented purpura 44.22 10.20 18 159720 92 29792648
Large for dates baby 40.37 10.20 35 159703 835 29791905
Patent ductus arteriosus 39.47 10.20 65 159673 3104 29789636
Cytomegalovirus infection 36.96 10.20 43 159695 23631 29769109
Epiphysiolysis 35.02 10.20 15 159723 89 29792651
Bone marrow failure 34.91 10.20 66 159672 29719 29763021
Tropical infectious disease 34.43 10.20 12 159726 36 29792704
Pituitary tumour recurrent 32.66 10.20 13 159725 62 29792678
Intentional product misuse 32.33 10.20 87 159651 34580 29758160
Immune reconstitution inflammatory syndrome 32.18 10.20 5 159733 9096 29783644
Fall 31.85 10.20 1228 158510 180644 29612096
Secondary hypogonadism 31.81 10.20 20 159718 285 29792455
Pneumocystis jirovecii pneumonia 31.42 10.20 27 159711 17093 29775647
Neoplasm recurrence 31.34 10.20 44 159694 1823 29790917
Suicide attempt 30.65 10.20 97 159641 36600 29756140
Thyroid hormones decreased 30.14 10.20 16 159722 162 29792578
Goitre 30.05 10.20 39 159699 1497 29791243
Blood testosterone decreased 30.02 10.20 70 159668 4326 29788414
Overdose 30.01 10.20 296 159442 84041 29708699
Hypophysitis 29.85 10.20 43 159695 1825 29790915
Macrocephaly 29.46 10.20 20 159718 327 29792413
Intentional overdose 29.09 10.20 118 159620 41363 29751377
Graft versus host disease 28.99 10.20 9 159729 10141 29782599
Pyrexia 28.35 10.20 1283 158455 293206 29499534
Infantile apnoea 28.26 10.20 29 159709 860 29791880
Electrocardiogram QRS complex abnormal 28.13 10.20 18 159720 265 29792475
Dizziness 27.79 10.20 1288 158450 193621 29599119
Neurotoxicity 27.79 10.20 18 159720 13164 29779576
Sepsis 27.59 10.20 583 159155 145812 29646928
Ventricular septal defect 27.24 10.20 59 159679 3470 29789270
Neonatal behavioural syndrome 27.21 10.20 13 159725 103 29792637
Walking aid user 27.16 10.20 36 159702 1411 29791329
Newborn persistent pulmonary hypertension 26.85 10.20 12 159726 80 29792660
Diabetic foetopathy 26.58 10.20 16 159722 210 29792530
Hepatic function abnormal 26.57 10.20 124 159614 41821 29750919
Adrenal insufficiency 26.18 10.20 118 159620 10345 29782395
Poisoning 26.17 10.20 14 159724 11368 29781372
Hypoglycaemia neonatal 26.12 10.20 37 159701 1546 29791194
Selective eating disorder 25.80 10.20 38 159700 1646 29791094
Product use in unapproved indication 25.65 10.20 260 159478 73433 29719307
Bronchopulmonary aspergillosis 25.59 10.20 17 159721 12267 29780473
Infective pulmonary exacerbation of cystic fibrosis 25.58 10.20 7 159731 8565 29784175
Palmar-plantar erythrodysaesthesia syndrome 25.56 10.20 151 159587 14719 29778021
Blood thyroid stimulating hormone normal 25.44 10.20 6 159732 0 29792740
Leukopenia 25.42 10.20 185 159553 55974 29736766
Multiple organ dysfunction syndrome 25.09 10.20 217 159521 63270 29729470
General physical health deterioration 24.98 10.20 704 159034 99240 29693500
Brain natriuretic peptide abnormal 24.85 10.20 14 159724 161 29792579
Decreased appetite 24.77 10.20 1006 158732 148904 29643836
Tri-iodothyronine decreased 24.68 10.20 9 159729 32 29792708
Substance abuse 24.59 10.20 4 159734 7036 29785704
Thyroxine free increased 24.34 10.20 15 159723 206 29792534
Papillary thyroid cancer 24.30 10.20 23 159715 617 29792123
Congenital mitral valve incompetence 24.29 10.20 11 159727 76 29792664
Rheumatoid arthritis 24.24 10.20 125 159613 41072 29751668
Pulmonary valve stenosis congenital 24.05 10.20 13 159725 137 29792603
Infusion related reaction 23.91 10.20 123 159615 40441 29752299
Granulocytopenia 23.56 10.20 80 159658 6146 29786594
Hypospadias 23.26 10.20 47 159691 2632 29790108
Pathogen resistance 23.06 10.20 8 159730 8402 29784338
Dysphonia 22.95 10.20 177 159561 18855 29773885
Interstitial lung disease 22.80 10.20 208 159530 59989 29732751
Anti-thyroid antibody positive 22.60 10.20 9 159729 43 29792697
Painful respiration 22.51 10.20 31 159707 1261 29791479
Toxic epidermal necrolysis 21.69 10.20 39 159699 17901 29774839
Septic shock 21.48 10.20 226 159512 63381 29729359
N-terminal prohormone brain natriuretic peptide abnormal 21.46 10.20 11 159727 103 29792637
Aortic aneurysm 21.35 10.20 79 159659 6334 29786406
Hyperprolactinaemia 21.22 10.20 29 159709 1171 29791569
Blood thyroid stimulating hormone 21.20 10.20 5 159733 0 29792740
Synovitis 21.11 10.20 13 159725 9770 29782970
Thyroiditis 21.08 10.20 34 159704 1595 29791145
Epstein-Barr virus infection 20.93 10.20 5 159733 6701 29786039
Thyroid hormones increased 20.83 10.20 8 159730 34 29792706
Fractured coccyx 20.65 10.20 12 159726 147 29792593
Cytomegalovirus viraemia 20.59 10.20 3 159735 5726 29787014
Anencephaly 20.59 10.20 11 159727 113 29792627
Death 20.55 10.20 1634 158104 355649 29437091
Haematotoxicity 20.48 10.20 4 159734 6166 29786574
Myxoedema coma 20.26 10.20 15 159723 283 29792457
Hypoacusis 20.22 10.20 137 159601 14002 29778738
Diarrhoea 20.19 10.20 2055 157683 332048 29460692
Growth retardation 20.17 10.20 33 159705 1567 29791173
Weight decreased 20.14 10.20 991 158747 149930 29642810
Dry skin 19.85 10.20 195 159543 22259 29770481
Coeliac disease 19.71 10.20 20 159718 585 29792155
Secondary hypothyroidism 19.63 10.20 8 159730 41 29792699
Intentional self-injury 19.63 10.20 26 159712 13506 29779234
Flatulence 19.36 10.20 164 159574 17965 29774775
Dermatomyositis 19.33 10.20 26 159712 1034 29791706
Neonatal respiratory distress syndrome 19.28 10.20 56 159682 3956 29788784
Glossodynia 19.22 10.20 50 159688 3311 29789429
Conduction disorder 19.09 10.20 36 159702 1915 29790825
Bradycardia neonatal 19.09 10.20 24 159714 892 29791848
Tachyarrhythmia 19.03 10.20 47 159691 3014 29789726
Cerebral atrophy congenital 18.88 10.20 8 159730 46 29792694
Post procedural hypothyroidism 18.86 10.20 5 159733 3 29792737
Rhythm idioventricular 18.69 10.20 14 159724 269 29792471
Febrile bone marrow aplasia 18.56 10.20 10 159728 8087 29784653
C-reactive protein increased 18.35 10.20 146 159592 43327 29749413
Drug reaction with eosinophilia and systemic symptoms 18.17 10.20 84 159654 28404 29764336
Pancytopenia 18.03 10.20 332 159406 84720 29708020
Growth hormone deficiency 18.00 10.20 12 159726 190 29792550
Diabetes insipidus 17.93 10.20 38 159700 2201 29790539
Contraindicated product administered 17.81 10.20 41 159697 17190 29775550
Aspergillus infection 17.68 10.20 17 159721 10197 29782543
Drug hypersensitivity 17.65 10.20 258 159480 68261 29724479
Tumour lysis syndrome 17.45 10.20 26 159712 12859 29779881
Metastatic renal cell carcinoma 17.37 10.20 40 159698 2452 29790288
Anaphylactic shock 17.29 10.20 30 159708 13963 29778777
Thyroxine increased 17.11 10.20 8 159730 60 29792680
Chest injury 17.02 10.20 28 159710 1336 29791404
Alanine aminotransferase increased 17 10.20 286 159452 73990 29718750
Oxygen saturation increased 16.98 10.20 12 159726 210 29792530
Pulmonary arterial pressure abnormal 16.79 10.20 11 159727 169 29792571
Product prescribing error 16.63 10.20 149 159589 16584 29776156
Exposure via breast milk 16.63 10.20 30 159708 1542 29791198
Neutropenic sepsis 16.47 10.20 22 159716 11387 29781353
Dehydration 16.43 10.20 811 158927 122728 29670012
Tri-iodothyronine increased 16.42 10.20 7 159731 41 29792699
Premature baby 16.27 10.20 148 159590 16543 29776197
Diffuse alopecia 16.10 10.20 5 159733 9 29792731
Mucosal inflammation 16.04 10.20 96 159642 30398 29762342
Alveolitis 15.96 10.20 31 159707 1686 29791054
Total lung capacity abnormal 15.94 10.20 11 159727 185 29792555
Coagulation disorder neonatal 15.91 10.20 6 159732 24 29792716
Hepatotoxicity 15.83 10.20 47 159691 18098 29774642
Tricuspid valve incompetence 15.76 10.20 89 159649 8534 29784206
Forced vital capacity decreased 15.73 10.20 20 159718 752 29791988
Cardiac arrest 15.70 10.20 376 159362 92474 29700266
Neutrophil count decreased 15.51 10.20 148 159590 42306 29750434
Tracheal fistula 15.51 10.20 8 159730 76 29792664
Blood growth hormone increased 15.44 10.20 11 159727 195 29792545
Intercapillary glomerulosclerosis 15.26 10.20 7 159731 50 29792690
Transplant rejection 15.16 10.20 16 159722 9190 29783550
Therapeutic product effect incomplete 15.04 10.20 112 159626 33722 29759018
Respiratory arrest 14.92 10.20 93 159645 29165 29763575
Shoulder dystocia 14.85 10.20 6 159732 30 29792710
Therapy non-responder 14.83 10.20 94 159644 29359 29763381
Hyponatraemia 14.78 10.20 466 159272 66736 29726004
Neonatal respiratory acidosis 14.70 10.20 7 159731 55 29792685
Thyroidectomy 14.70 10.20 7 159731 55 29792685
Haemangioma congenital 14.66 10.20 16 159722 510 29792230
Cortisol decreased 14.48 10.20 21 159717 897 29791843
Blood glucose increased 14.42 10.20 430 159308 61100 29731640
Osteochondroma 14.34 10.20 5 159733 15 29792725
Epispadias 14.20 10.20 10 159728 174 29792566
Constipation 14.15 10.20 737 159001 112169 29680571
Thyroid cancer metastatic 14.09 10.20 6 159732 35 29792705
Hypotonia neonatal 14.04 10.20 22 159716 1007 29791733
Aorticopulmonary septal defect 13.88 10.20 5 159733 17 29792723
Primary hypothyroidism 13.68 10.20 6 159732 38 29792702
Drug intolerance 13.68 10.20 165 159573 45126 29747614
Urine oxalate increased 13.66 10.20 5 159733 18 29792722
Pituitary tumour 13.60 10.20 15 159723 484 29792256
Hypothalamo-pituitary disorder 13.58 10.20 17 159721 629 29792111
Tongue movement disturbance 13.53 10.20 7 159731 67 29792673
Delirium 13.45 10.20 145 159593 40486 29752254
Maternal exposure during breast feeding 13.42 10.20 28 159710 1604 29791136
Follicular thyroid cancer 13.32 10.20 4 159734 6 29792734
Parasitic gastroenteritis 13.32 10.20 4 159734 6 29792734
Medulloblastoma recurrent 13.26 10.20 7 159731 70 29792670
Alcohol abuse 13.19 10.20 6 159732 5347 29787393
Sedation 13.17 10.20 44 159694 16329 29776411
Toxic neuropathy 13.16 10.20 13 159725 368 29792372
Bradycardia 13.03 10.20 449 159289 65077 29727663
Haemophagocytic lymphohistiocytosis 13.03 10.20 20 159718 9771 29782969
Ankylosing spondylitis 12.98 10.20 4 159734 4530 29788210
Nephropathy toxic 12.97 10.20 23 159715 10616 29782124
Acute graft versus host disease in skin 12.90 10.20 4 159734 4512 29788228
Pituitary apoplexy 12.88 10.20 5 159733 22 29792718
Mucormycosis 12.83 10.20 6 159732 5262 29787478
Neonatal respiratory failure 12.83 10.20 12 159726 317 29792423
Body temperature 12.72 10.20 3 159735 0 29792740
Thyroid cancer recurrent 12.72 10.20 3 159735 0 29792740
Rathke's cleft cyst 12.72 10.20 3 159735 0 29792740
Polyglandular autoimmune syndrome type II 12.72 10.20 3 159735 0 29792740
Subgaleal haematoma 12.71 10.20 5 159733 23 29792717
Full blood count decreased 12.70 10.20 134 159604 15583 29777157
Hyperbilirubinaemia neonatal 12.70 10.20 17 159721 673 29792067
Neonatal respiratory distress 12.64 10.20 14 159724 454 29792286
Muscular weakness 12.63 10.20 436 159302 63209 29729531
Thyroid operation 12.61 10.20 4 159734 8 29792732
Neonatal pneumothorax 12.61 10.20 4 159734 8 29792732
Poisoning deliberate 12.53 10.20 8 159730 5896 29786844
Seroma 12.51 10.20 16 159722 605 29792135
Drug interaction 12.48 10.20 906 158832 198662 29594078
Serotonin syndrome 12.47 10.20 51 159687 17840 29774900
Lumbar puncture 12.39 10.20 7 159731 81 29792659
Brachydactyly 12.38 10.20 9 159729 165 29792575
Ageusia 12.36 10.20 86 159652 8867 29783873
Hypernatraemia 12.23 10.20 75 159663 7409 29785331
Respiratory depression 12.19 10.20 27 159711 11476 29781264
Dependence on oxygen therapy 12.15 10.20 8 159730 124 29792616
Polycythaemia 12.08 10.20 28 159710 1724 29791016
Syncope 12.04 10.20 561 159177 84342 29708398
Cranial sutures widening 12.03 10.20 7 159731 86 29792654
Floppy infant 12.03 10.20 7 159731 86 29792654
Atrial fibrillation 12.01 10.20 698 159040 107426 29685314
Hypertensive angiopathy 12.00 10.20 4 159734 10 29792730
Oedema peripheral 11.91 10.20 684 159054 105148 29687592
Foreign body in throat 11.81 10.20 6 159732 55 29792685
Adenovirus infection 11.81 10.20 4 159734 4264 29788476
Metastases to the mediastinum 11.71 10.20 9 159729 180 29792560
Bone cancer 11.66 10.20 22 159716 1171 29791569
Maternal exposure during pregnancy 11.50 10.20 46 159692 3825 29788915
Gastrooesophageal cancer 11.49 10.20 5 159733 31 29792709
Sopor 11.48 10.20 26 159712 10965 29781775
Skin indentation 11.48 10.20 4 159734 12 29792728
Thyroxine abnormal 11.48 10.20 4 159734 12 29792728
Thrombocytopenia neonatal 11.47 10.20 11 159727 300 29792440
Urticaria 11.30 10.20 214 159524 54392 29738348
Cerebrovascular accident 11.29 10.20 549 159189 82928 29709812
Neoplasm progression 11.16 10.20 146 159592 17877 29774863
Hypersensitivity 11.10 10.20 212 159526 53816 29738924
Pharyngeal fistula 11.02 10.20 4 159734 14 29792726
Performance enhancing product use 11 10.20 7 159731 102 29792638
Liposarcoma 11 10.20 7 159731 102 29792638
Hospice care 10.98 10.20 50 159688 4402 29788338
Reaction to excipient 10.96 10.20 12 159726 384 29792356
Application site erythema 10.93 10.20 32 159706 2271 29790469
Brain oedema 10.90 10.20 32 159706 12366 29780374
Anaphylactic reaction 10.89 10.20 96 159642 27886 29764854
Thunderclap headache 10.88 10.20 6 159732 66 29792674
Cervicogenic headache 10.80 10.20 4 159734 15 29792725
Growth hormone-producing pituitary tumour 10.80 10.20 4 159734 15 29792725
Wrong drug 10.80 10.20 6 159732 67 29792673
Pseudomonas infection 10.79 10.20 25 159713 10457 29782283
Gangrene neonatal 10.73 10.20 9 159729 205 29792535
Weight decrease neonatal 10.73 10.20 11 159727 326 29792414
Talipes 10.71 10.20 26 159712 1649 29791091
Oral discomfort 10.71 10.20 34 159704 2522 29790218
Neonatal seizure 10.69 10.20 13 159725 467 29792273
Chromophobe renal cell carcinoma 10.65 10.20 3 159735 3 29792737
Abdominoplasty 10.65 10.20 3 159735 3 29792737
Product dose omission issue 10.65 10.20 594 159144 91037 29701703
Monocyte count abnormal 10.64 10.20 5 159733 38 29792702
Medullary thyroid cancer 10.64 10.20 5 159733 38 29792702
Congenital hypothyroidism 10.60 10.20 4 159734 16 29792724
Atrioventricular block first degree 10.59 10.20 59 159679 5629 29787111
BK virus infection 10.59 10.20 5 159733 4359 29788381
Pupils unequal 10.55 10.20 22 159716 1260 29791480
Lymphocyte count decreased 10.55 10.20 59 159679 18996 29773744
Application site inflammation 10.55 10.20 7 159731 110 29792630
Hypothermia 10.45 10.20 87 159651 9480 29783260
Prescribed underdose 10.40 10.20 74 159664 7685 29785055
Blood prolactin decreased 10.39 10.20 10 159728 274 29792466
Hypersomnia 10.36 10.20 99 159639 11217 29781523
Altered state of consciousness 10.32 10.20 63 159675 19856 29772884
Pulmonary artery stenosis 10.29 10.20 8 159730 163 29792577
Axillary pain 10.27 10.20 9 159729 218 29792522
Blood chromogranin A increased 10.24 10.20 8 159730 164 29792576

Pharmacologic Action:

SourceCodeDescription
ATC H03AA01 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 agents
CHEBI has role CHEBI:60311 thyroid hormones
CHEBI has role CHEBI:75771 mus musculus metabolite
CHEBI has role CHEBI:77746 h. sapiens metabolites
CHEBI has role CHEBI:52290 mitogens
CHEBI has role CHEBI:53000 epitope function

Drug Use (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

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)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Thyroid hormone receptor beta Nuclear hormone receptor AGONIST IC50 8.52 IUPHAR CHEMBL
Thyroid hormone receptor alpha Nuclear hormone receptor AGONIST UNKNOWN IUPHAR
THAP domain-containing protein 1 Unclassified WOMBAT-PK
Transthyretin Secreted IC50 4.98 CHEMBL
Bile acid receptor Nuclear hormone receptor IC50 5.10 CHEMBL
Thyroid hormone receptor beta Transcription factor IC50 7.46 CHEMBL

External reference:

IDSource
4017826 VUID
N0000179290 NUI
D01010 KEGG_DRUG
6106-07-6 SECONDARY_CAS_RN
4017826 VANDF
4022126 VANDF
C0040165 UMLSCUI
CHEBI:18332 CHEBI
T44 PDB_CHEM_ID
CHEMBL1624 ChEMBL_ID
CHEMBL2103741 ChEMBL_ID
CHEMBL559 ChEMBL_ID
CHEMBL42115 ChEMBL_ID
D013974 MESH_DESCRIPTOR_UI
DB00451 DRUGBANK_ID
453 INN_ID
Q51BO43MG4 UNII
5819 PUBCHEM_CID
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-3727 TABLET 137 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4341 TABLET 25 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-4552 TABLET 50 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-5182 TABLET 75 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6594 TABLET 88 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-6624 TABLET 100 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7068 TABLET 125 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7069 TABLET 150 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7070 TABLET 175 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7148 TABLET 200 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-7149 TABLET 300 ug ORAL NDA 24 sections
Synthroid HUMAN PRESCRIPTION DRUG LABEL 1 0074-9296 TABLET 112 ug ORAL NDA 24 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1800 TABLET 25 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1803 TABLET 50 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1805 TABLET 75 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1807 TABLET 88 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1809 TABLET 100 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1811 TABLET 112 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1813 TABLET 125 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1815 TABLET 150 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1817 TABLET 175 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1819 TABLET 200 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1821 TABLET 300 ug ORAL ANDA 26 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0378-1823 TABLET 137 ug ORAL ANDA 26 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1370 TABLET 0.03 mg ORAL NDA 24 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1371 TABLET 0.05 mg ORAL NDA 24 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1372 TABLET 0.08 mg ORAL NDA 24 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1373 TABLET 0.09 mg ORAL NDA 24 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1374 TABLET 0.10 mg ORAL NDA 24 sections
UNITHROID HUMAN PRESCRIPTION DRUG LABEL 1 0527-1375 TABLET 0.11 mg ORAL NDA 24 sections