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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 1839.88 24.80 508 3849 20526 2333202
Blood thyroid stimulating hormone increased 683.14 24.80 130 4227 867 2352861
Toxicity to various agents 656.94 24.80 262 4095 32492 2321236
Hyperthyroidism 597.82 24.80 132 4225 1965 2351763
Product substitution issue 510.13 24.80 138 4219 4931 2348797
Hypothyroidism 479.80 24.80 128 4229 4329 2349399
Fatigue 448.31 24.80 273 4084 84600 2269128
Blood thyroid stimulating hormone abnormal 401.39 24.80 64 4293 112 2353616
Overdose 358.73 24.80 148 4209 19759 2333969
Suicide attempt 339.80 24.80 122 4235 11160 2342568
Drug interaction 338.19 24.80 159 4198 29004 2324724
Hypotension 337.12 24.80 164 4193 32272 2321456
Drug ineffective 325.70 24.80 240 4117 101384 2252344
Palpitations 319.02 24.80 129 4228 16327 2337401
Intentional overdose 305.79 24.80 113 4244 11208 2342520
Thyroid function test abnormal 274.47 24.80 56 4301 551 2353177
Drug hypersensitivity 265.19 24.80 158 4199 46485 2307243
Product complaint 252.35 24.80 78 4279 4460 2349268
Alopecia 230.34 24.80 112 4245 21889 2331839
Blood thyroid stimulating hormone decreased 223.67 24.80 47 4310 540 2353188
Weight increased 216.78 24.80 108 4249 22229 2331499
Headache 206.83 24.80 167 4190 80012 2273716
Dizziness 196.81 24.80 143 4214 58522 2295206
Feeling abnormal 196.79 24.80 103 4254 23478 2330250
Nausea 193.86 24.80 186 4171 112003 2241725
Therapeutic response unexpected 188.07 24.80 60 4297 3799 2349929
Malaise 185.25 24.80 135 4222 55450 2298278
Vomiting 182.04 24.80 148 4209 71454 2282274
Maternal exposure during pregnancy 174.67 24.80 82 4275 14781 2338947
Bradycardia 165.14 24.80 70 4287 9911 2343817
Dyspnoea 161.70 24.80 144 4213 78589 2275139
Asthenia 160.81 24.80 116 4241 46810 2306918
Cardiac arrest 159.03 24.80 77 4280 14853 2338875
Fall 158.14 24.80 115 4242 46984 2306744
Cardio-respiratory arrest 154.14 24.80 65 4292 9081 2344647
Constipation 153.80 24.80 85 4272 21544 2332184
Foetal exposure during pregnancy 151.06 24.80 55 4302 5197 2348531
Hyperhidrosis 147.74 24.80 74 4283 15348 2338380
Abortion spontaneous 133.14 24.80 66 4291 13379 2340349
Rash 132.21 24.80 114 4243 59444 2294284
Loss of consciousness 125.85 24.80 71 4286 18696 2335032
Weight decreased 125.03 24.80 82 4275 28289 2325439
Pruritus 121.32 24.80 95 4262 43245 2310483
Tachycardia 120.73 24.80 66 4291 16343 2337385
Anxiety 120.07 24.80 81 4276 29278 2324450
Somnolence 118.64 24.80 74 4283 23411 2330317
Product quality issue 115.68 24.80 56 4301 10773 2342955
Insomnia 114.74 24.80 75 4282 25712 2328016
Circulatory collapse 114.59 24.80 41 4316 3679 2350049
Atrial fibrillation 114.24 24.80 60 4297 13708 2340020
Depression 113.55 24.80 77 4280 28055 2325673
Hypertension 113.09 24.80 76 4281 27285 2326443
Exposure during pregnancy 111.35 24.80 73 4284 25146 2328582
Intentional product misuse 110.26 24.80 52 4305 9437 2344291
Condition aggravated 109.20 24.80 79 4278 31900 2321828
Acute kidney injury 108.82 24.80 75 4282 28047 2325681
Asphyxia 108.54 24.80 29 4328 975 2352753
Respiratory arrest 104.33 24.80 44 4313 6134 2347594
Tremor 104.06 24.80 65 4292 20596 2333132
Diarrhoea 103.00 24.80 116 4241 83448 2270280
Bradypnoea 99.94 24.80 23 4334 411 2353317
Oliguria 99.89 24.80 29 4328 1328 2352400
Arteriosclerosis coronary artery 99.51 24.80 28 4329 1145 2352583
Lethargy 95.79 24.80 46 4311 8684 2345044
Balance disorder 93.92 24.80 47 4310 9700 2344028
Drug intolerance 92.17 24.80 52 4305 13665 2340063
Electrocardiogram QRS complex prolonged 92.10 24.80 26 4331 1076 2352652
Hypoglycaemia 88.32 24.80 43 4314 8364 2345364
Brain injury 87.42 24.80 24 4333 895 2352833
Feeling cold 86.86 24.80 32 4325 3118 2350610
Product dispensing error 85.83 24.80 30 4327 2511 2351217
Hyponatraemia 85.45 24.80 49 4308 13276 2340452
Myalgia 85.00 24.80 60 4297 23273 2330455
Premature delivery 82.71 24.80 31 4326 3169 2350559
Disturbance in attention 81.26 24.80 36 4321 5649 2348079
Decreased appetite 79.98 24.80 63 4294 28828 2324900
Heart rate increased 79.77 24.80 44 4313 11061 2342667
Live birth 79.35 24.80 24 4333 1267 2352461
Dysphagia 79.20 24.80 46 4311 12759 2340969
Thyroid disorder 78.80 24.80 25 4332 1548 2352180
Exophthalmos 74.65 24.80 17 4340 289 2353439
Cough 74.47 24.80 64 4293 33053 2320675
Blood pressure increased 74.47 24.80 49 4308 16937 2336791
Depressed level of consciousness 74.22 24.80 37 4320 7567 2346161
Electrocardiogram QT prolonged 73.26 24.80 37 4320 7777 2345951
Agitation 71.80 24.80 41 4316 11010 2342718
Poisoning 71.71 24.80 27 4330 2793 2350935
Incorrect dose administered 71.24 24.80 39 4318 9656 2344072
Drug abuse 71.20 24.80 42 4315 11984 2341744
Memory impairment 70.97 24.80 43 4314 12880 2340848
Hypersensitivity 70.83 24.80 54 4303 23539 2330189
Thyroxine increased 70.36 24.80 13 4344 71 2353657
Dry skin 69.78 24.80 34 4323 6618 2347110
Confusional state 69.33 24.80 54 4303 24290 2329438
Abdominal distension 68.64 24.80 39 4318 10372 2343356
Pain 67.85 24.80 81 4276 61776 2291952
Syncope 67.53 24.80 46 4311 16829 2336899
Urticaria 67.32 24.80 53 4304 24208 2329520
Thyrotoxic crisis 66.88 24.80 14 4343 157 2353571
Thyroxine free decreased 65.35 24.80 12 4345 63 2353665
Therapeutic product effect decreased 64.70 24.80 38 4319 10751 2342977
Lactic acidosis 64.31 24.80 30 4327 5300 2348428
Basedow's disease 64.23 24.80 17 4340 550 2353178
Oedema peripheral 63.97 24.80 51 4306 23712 2330016
Muscular weakness 62.93 24.80 42 4315 14855 2338873
Seizure 62.66 24.80 51 4306 24415 2329313
Blood creatine phosphokinase increased 62.25 24.80 29 4328 5107 2348621
Product packaging confusion 61.58 24.80 11 4346 48 2353680
Abdominal discomfort 61.47 24.80 44 4313 17412 2336316
Premature baby 61.43 24.80 25 4332 3179 2350549
Reaction to excipient 61.25 24.80 15 4342 353 2353375
Generalised tonic-clonic seizure 61.01 24.80 29 4328 5343 2348385
Sedation 60.27 24.80 25 4332 3337 2350391
Thyroxine free increased 59.04 24.80 12 4345 115 2353613
Pulseless electrical activity 58.67 24.80 18 4339 997 2352731
Arthralgia 57.71 24.80 70 4287 54215 2299513
Death 57.50 24.80 86 4271 81382 2272346
Dry mouth 57.33 24.80 32 4325 8221 2345507
Hypokalaemia 57.32 24.80 35 4322 10619 2343109
Orthostatic hypotension 57.04 24.80 23 4334 2856 2350872
Sepsis 56.97 24.80 43 4314 18445 2335283
Urinary tract infection 55.66 24.80 52 4305 29890 2323838
Gait disturbance 55.64 24.80 46 4311 22499 2331229
Abdominal pain 55.06 24.80 55 4302 34319 2319409
Arrhythmia 54.91 24.80 28 4329 6000 2347728
Feeling jittery 54.63 24.80 20 4337 1912 2351816
Stevens-Johnson syndrome 54.58 24.80 25 4332 4234 2349494
Coma 54.56 24.80 32 4325 9024 2344704
Sciatica 52.77 24.80 20 4337 2105 2351623
Cognitive disorder 51.95 24.80 26 4331 5355 2348373
Gastrointestinal motility disorder 50.70 24.80 14 4343 533 2353195
Thyrotoxic periodic paralysis 50.00 24.80 7 4350 1 2353727
Diplopia 49.68 24.80 22 4335 3443 2350285
Subarachnoid haemorrhage 49.40 24.80 19 4338 2081 2351647
Caesarean section 49.32 24.80 23 4334 4058 2349670
Hand deformity 49.23 24.80 16 4341 1070 2352658
Adrenal insufficiency 49.08 24.80 17 4340 1383 2352345
Electrocardiogram T wave inversion 48.33 24.80 14 4343 635 2353093
Drug level changed 48.20 24.80 10 4347 107 2353621
Polyuria 47.89 24.80 16 4341 1166 2352562
Premature rupture of membranes 47.87 24.80 15 4342 891 2352837
Disorientation 47.81 24.80 26 4331 6346 2347382
Muscle spasms 47.04 24.80 41 4316 21525 2332203
Depressed mood 46.92 24.80 24 4333 5174 2348554
Temperature intolerance 46.46 24.80 15 4342 982 2352746
Vitamin B12 decreased 46.05 24.80 12 4345 365 2353363
Vertigo 45.85 24.80 29 4328 9355 2344373
Off label use 45.32 24.80 73 4284 73525 2280203
Hot flush 44.84 24.80 26 4331 7173 2346555
Abdominal pain upper 44.20 24.80 40 4317 22060 2331668
Nervousness 44.07 24.80 23 4334 5166 2348562
Dysgeusia 43.48 24.80 27 4330 8432 2345296
Chest pain 43.16 24.80 44 4313 28093 2325635
Contraindicated product administered 42.73 24.80 19 4338 3002 2350726
Rhabdomyolysis 41.19 24.80 24 4333 6680 2347048
Low birth weight baby 40.79 24.80 13 4344 816 2352912
Hyperlactacidaemia 40.37 24.80 11 4346 398 2353330
Inappropriate affect 40.36 24.80 10 4347 247 2353481
Placental insufficiency 40.33 24.80 10 4347 248 2353480
Abnormal behaviour 40.14 24.80 21 4336 4739 2348989
Dehydration 40.03 24.80 38 4319 22257 2331471
Oesophagitis 39.64 24.80 16 4341 1990 2351738
Neutrophil count abnormal 39.40 24.80 11 4346 436 2353292
Haemoglobin abnormal 38.79 24.80 12 4345 683 2353045
Hyperkalaemia 38.61 24.80 22 4335 5871 2347857
Foetal non-stress test abnormal 38.58 24.80 6 4351 8 2353720
Parkinson's disease 38.50 24.80 14 4343 1312 2352416
White blood cell count abnormal 38.45 24.80 12 4345 703 2353025
Myocardial ischaemia 37.78 24.80 16 4341 2246 2351482
Visual impairment 37.66 24.80 28 4329 11727 2342001
Dyspepsia 37.38 24.80 26 4331 9818 2343910
Milk-alkali syndrome 36.85 24.80 8 4349 108 2353620
Irritability 36.84 24.80 22 4335 6405 2347323
Urinary incontinence 36.63 24.80 19 4338 4214 2349514
Status epilepticus 36.38 24.80 16 4341 2462 2351266
Eye pruritus 36.05 24.80 16 4341 2515 2351213
Ventricular arrhythmia 35.90 24.80 11 4346 606 2353122
Goitre 35.88 24.80 12 4345 877 2352851
Swelling face 35.87 24.80 25 4332 9468 2344260
Acidosis 35.85 24.80 14 4343 1596 2352132
Adrenocortical insufficiency acute 35.78 24.80 9 4348 237 2353491
Mood swings 35.14 24.80 17 4340 3252 2350476
Pulmonary toxicity 34.71 24.80 11 4346 678 2353050
Gastrointestinal hypomotility 34.65 24.80 9 4348 270 2353458
Drug level increased 34.58 24.80 16 4341 2771 2350957
Logorrhoea 33.99 24.80 10 4347 479 2353249
Renal failure 33.89 24.80 31 4326 17318 2336410
Thyroxine decreased 33.31 24.80 7 4350 80 2353648
Blister 33.25 24.80 21 4336 6750 2346978
Pulse abnormal 33.10 24.80 9 4348 323 2353405
Blood sodium decreased 32.95 24.80 16 4341 3084 2350644
Medication error 32.60 24.80 20 4337 6111 2347617
Loss of personal independence in daily activities 32.59 24.80 19 4338 5292 2348436
Gastrooesophageal reflux disease 32.16 24.80 23 4334 9072 2344656
Autoimmune thyroiditis 32.02 24.80 10 4347 587 2353141
Treatment failure 31.97 24.80 21 4336 7218 2346510
Product odour abnormal 31.92 24.80 9 4348 370 2353358
Dysphonia 31.91 24.80 20 4337 6344 2347384
Mood altered 31.70 24.80 15 4342 2731 2350997
Tachypnoea 31.46 24.80 14 4343 2215 2351513
Tri-iodothyronine increased 31.07 24.80 6 4351 43 2353685
Psychomotor skills impaired 30.96 24.80 9 4348 413 2353315
Hepatic cirrhosis 30.73 24.80 14 4343 2339 2351389
Pericarditis constrictive 30.60 24.80 6 4351 47 2353681
Cardiac failure 30.48 24.80 25 4332 12069 2341659
Burning sensation 30.47 24.80 21 4336 7807 2345921
Tri-iodothyronine decreased 30.38 24.80 6 4351 49 2353679
Pre-eclampsia 29.73 24.80 12 4345 1492 2352236
Blood pressure decreased 29.58 24.80 22 4335 9214 2344514
Psychotic disorder 29.40 24.80 17 4340 4662 2349066
Treatment noncompliance 29.29 24.80 18 4339 5516 2348212
Pneumonia 29.06 24.80 48 4309 49248 2304480
Neurosis 29.02 24.80 6 4351 63 2353665
Blood calcium decreased 28.69 24.80 13 4344 2145 2351583
Intentional self-injury 28.64 24.80 16 4341 4111 2349617
Hypertelorism of orbit 28.44 24.80 6 4351 70 2353658
Polyhydramnios 28.42 24.80 8 4349 327 2353401
Chest discomfort 28.34 24.80 26 4331 14569 2339159
Interstitial lung disease 28.18 24.80 20 4337 7792 2345936
Musculoskeletal stiffness 28.14 24.80 24 4333 12223 2341505
Toxoplasmosis 28.10 24.80 7 4350 177 2353551
Haematocrit decreased 27.96 24.80 16 4341 4302 2349426
Discomfort 27.86 24.80 17 4340 5142 2348586
Oral discomfort 27.85 24.80 11 4346 1292 2352436
Endocrine ophthalmopathy 27.77 24.80 6 4351 79 2353649
Colitis microscopic 27.61 24.80 10 4347 926 2352802
Paraesthesia 27.60 24.80 31 4326 22057 2331671
Schizoaffective disorder bipolar type 27.60 24.80 5 4352 24 2353704
Product solubility abnormal 27.59 24.80 7 4350 191 2353537
Gestational diabetes 27.19 24.80 11 4346 1376 2352352
Amnesia 27.16 24.80 19 4338 7234 2346494
Restlessness 27.14 24.80 16 4341 4547 2349181
Deep vein thrombosis 27.00 24.80 24 4333 12908 2340820
Psychomotor hyperactivity 26.89 24.80 12 4345 1910 2351818
Dysmorphism 26.84 24.80 8 4349 401 2353327
Sleep disorder 26.66 24.80 18 4339 6471 2347257
Vision blurred 26.30 24.80 25 4332 14643 2339085
Acute respiratory distress syndrome 26.27 24.80 14 4343 3278 2350450
Sputum discoloured 25.47 24.80 10 4347 1156 2352572
Ear discomfort 25.36 24.80 10 4347 1170 2352558
Cardiac murmur 25.34 24.80 11 4346 1640 2352088
Lacrimation increased 25.34 24.80 13 4344 2817 2350911
General physical health deterioration 25.17 24.80 24 4333 14115 2339613
Acute hepatitis B 24.88 24.80 5 4352 45 2353683

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Completed suicide 745.24 38.07 202 1088 16110 1729381
Foetal exposure during pregnancy 349.43 38.07 92 1198 6267 1739224
Toxicity to various agents 245.62 38.07 102 1188 29039 1716452
Blood thyroid stimulating hormone increased 166.36 38.07 33 1257 606 1744885
Atrial septal defect 141.57 38.07 33 1257 1325 1744166
Blood thyroid stimulating hormone abnormal 122.88 38.07 18 1272 40 1745451
Atrial fibrillation 103.62 38.07 46 1244 15065 1730426
Tricuspid valve incompetence 102.41 38.07 25 1265 1221 1744270
Premature baby 98.42 38.07 29 1261 2913 1742578
Hypothyroidism 97.89 38.07 28 1262 2532 1742959
Macrocephaly 90.88 38.07 14 1276 49 1745442
Product substitution issue 78.42 38.07 25 1265 3261 1742230
N-terminal prohormone brain natriuretic peptide abnormal 77.31 38.07 10 1280 3 1745488
Circulatory collapse 77.10 38.07 25 1265 3442 1742049
Pyloric stenosis 76.83 38.07 14 1276 158 1745333
Hyperthyroidism 72.73 38.07 20 1270 1562 1743929
Cardio-respiratory arrest 72.39 38.07 31 1259 9262 1736229
Drug interaction 71.68 38.07 44 1246 27914 1717577
Brain natriuretic peptide abnormal 69.64 38.07 10 1280 18 1745473
Pulmonary arterial pressure abnormal 67.70 38.07 10 1280 24 1745467
Oxygen saturation increased 67.70 38.07 10 1280 24 1745467
Fractured coccyx 67.13 38.07 10 1280 26 1745465
Large for dates baby 66.55 38.07 12 1278 127 1745364
Hypertension 63.98 38.07 36 1254 19412 1726079
Electrocardiogram QRS complex abnormal 61.07 38.07 10 1280 56 1745435
Type 2 diabetes mellitus 60.51 38.07 18 1272 1860 1743631
Pupils unequal 60.21 38.07 12 1278 224 1745267
Thyroiditis 59.63 38.07 13 1277 381 1745110
General physical health deterioration 59.22 38.07 30 1260 13088 1732403
Goitre 57.26 38.07 12 1278 290 1745201
Gangrene neonatal 55.01 38.07 7 1283 1 1745490
Intentional overdose 54.50 38.07 24 1266 7646 1737845
Performance enhancing product use 54.19 38.07 7 1283 2 1745489
Diabetic foetopathy 53.92 38.07 8 1282 20 1745471
Left ventricular dilatation 53.88 38.07 9 1281 58 1745433
Ejection fraction decreased 53.19 38.07 17 1273 2228 1743263
Autoimmune thyroiditis 52.88 38.07 11 1279 256 1745235
Weight decrease neonatal 52.61 38.07 8 1282 25 1745466
Drug hypersensitivity 52.40 38.07 29 1261 15106 1730385
Hypotension 52.35 38.07 37 1253 29617 1715874
Oedema peripheral 51.67 38.07 29 1261 15521 1729970
Dyspnoea 51.17 38.07 46 1244 52013 1693478
Secondary hypogonadism 50.93 38.07 9 1281 84 1745407
Fatigue 50.16 38.07 45 1245 50736 1694755
Low birth weight baby 49.14 38.07 13 1277 874 1744617
Gait disturbance 48.63 38.07 26 1264 12644 1732847
Cardiac failure chronic 48.14 38.07 12 1278 636 1744855
Intercapillary glomerulosclerosis 47.93 38.07 7 1283 15 1745476
Foetal growth restriction 47.50 38.07 12 1278 672 1744819
C-reactive protein abnormal 47.12 38.07 10 1280 257 1745234
Rhabdomyolysis 46.07 38.07 24 1266 11066 1734425
Thyroid disorder 45.71 38.07 11 1279 503 1744988
Glucose tolerance decreased 43.31 38.07 6 1284 7 1745484
Exposure via breast milk 41.49 38.07 9 1281 257 1745234
Speech disorder 41.48 38.07 17 1273 4531 1740960
Ventricular septal defect 41.18 38.07 11 1279 767 1744724
Diabetes mellitus 40.77 38.07 19 1271 6889 1738602
Renal failure 40.02 38.07 27 1263 19990 1725501
Skin turgor decreased 39.54 38.07 7 1283 66 1745425
Mitral valve incompetence 39.08 38.07 13 1277 1929 1743562
Disseminated intravascular coagulation 38.11 38.07 15 1275 3599 1741892

Pharmacologic Action:

SourceCodeDescription
ATC H03AA01 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
THYROID THERAPY
THYROID PREPARATIONS
Thyroid hormones
FDA EPC N0000175945 l-Thyroxine
FDA CS M0021504 Thyroxine

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)

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 efficacy 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 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
C0079691 UMLSCUI
D01010 KEGG_DRUG
054I36CPMN UNII
453 INN_ID
55-03-8 SECONDARY_CAS_RN
768532006 SNOMEDCT_US
73187006 SNOMEDCT_US
38076006 SNOMEDCT_US
10582 RXNORM
4022126 VANDF
d00278 MMSL
005896 NDDF
710809001 SNOMEDCT_US
004881 NDDF
CHEMBL559 ChEMBL_ID
CHEMBL42115 ChEMBL_ID
DB00451 DRUGBANK_ID
CHEMBL1624 ChEMBL_ID
CHEBI:6446 CHEBI
D013974 MESH_DESCRIPTOR_UI
CHEMBL2103741 ChEMBL_ID
5819 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1341 TABLET 0.03 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1342 TABLET 0.05 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1343 TABLET 0.08 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1344 TABLET 0.09 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1345 TABLET 0.10 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1346 TABLET 0.11 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1347 TABLET 0.13 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1349 TABLET 0.15 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1350 TABLET 0.18 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1351 TABLET 0.20 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1352 TABLET 0.30 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0527-1638 TABLET 0.14 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-302 TABLET 0.10 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-403 TABLET 0.05 mg ORAL NDA 11 sections
LEVOTHYROXINE SODIUM HUMAN PRESCRIPTION DRUG LABEL 1 16590-977 TABLET 0.11 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-748 TABLET 0.03 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-749 TABLET 0.05 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-750 TABLET 0.08 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-751 TABLET 0.09 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-752 TABLET 0.10 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-753 TABLET 0.11 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-754 TABLET 0.13 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-755 TABLET 0.14 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-756 TABLET 0.15 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-757 TABLET 0.18 mg ORAL NDA 11 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 21695-758 TABLET 0.20 mg ORAL NDA 10 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 42023-201 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 ug INTRAVENOUS NDA 16 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 42023-202 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 200 ug INTRAVENOUS NDA 16 sections
Levothyroxine Sodium HUMAN PRESCRIPTION DRUG LABEL 1 42023-203 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 ug INTRAVENOUS NDA 16 sections
NP Thyroid 15 HUMAN PRESCRIPTION DRUG LABEL 2 42192-327 TABLET 9.50 ug ORAL unapproved drug other 21 sections