simvastatin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihyperlipidaemic substances, HMG CoA reductase inhibitors 2445 79902-63-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • simvastatin
  • sinvacor
  • simvastol
A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.
  • Molecular weight: 418.57
  • Formula: C25H38O5
  • CLOGP: 4.48
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 72.83
  • ALOGS: -4.53
  • ROTB: 7

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
30 mg O
30 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.03 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.37 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 3 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 23, 1991 FDA MERCK

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
Rhabdomyolysis 2700.73 34.30 579 4851 6125 2346530
Myalgia 2082.15 34.30 601 4829 22732 2329923
Drug interaction 1429.30 34.30 476 4954 28687 2323968
Blood creatine phosphokinase increased 1035.87 34.30 254 5176 4882 2347773
Myopathy 874.79 34.30 178 5252 1365 2351290
Muscular weakness 752.25 34.30 250 5180 14647 2338008
Acute kidney injury 651.99 34.30 266 5164 27856 2324799
Muscle spasms 512.67 34.30 208 5222 21358 2331297
Pain in extremity 471.82 34.30 241 5189 42299 2310356
Completed suicide 452.58 34.30 189 5241 20845 2331810
Drug hypersensitivity 445.23 34.30 239 5191 46404 2306251
Myositis 361.36 34.30 84 5346 1251 2351404
Arthralgia 343.37 34.30 213 5217 54072 2298583
Fatigue 336.24 34.30 249 5181 84624 2268031
Alanine aminotransferase increased 314.47 34.30 130 5300 13902 2338753
Dyspnoea 298.14 34.30 225 5205 78508 2274147
Asthenia 283.42 34.30 179 5251 46747 2305908
Liver function test abnormal 269.66 34.30 98 5332 7392 2345263
Fall 253.08 34.30 167 5263 46932 2305723
Malaise 251.09 34.30 177 5253 55408 2297247
Pain 243.06 34.30 181 5249 61676 2290979
Oedema peripheral 234.76 34.30 125 5305 23638 2329017
Confusional state 234.73 34.30 126 5304 24218 2328437
Dizziness 226.67 34.30 170 5260 58495 2294160
Drug intolerance 215.44 34.30 99 5331 13618 2339037
Toxicity to various agents 202.47 34.30 127 5303 32627 2320028
Headache 201.75 34.30 181 5249 79998 2272657
Aspartate aminotransferase increased 194.81 34.30 90 5340 12522 2340133
Depression 194.00 34.30 117 5313 28015 2324640
Immune-mediated myositis 189.20 34.30 35 5395 148 2352507
Atrial fibrillation 184.24 34.30 89 5341 13679 2338976
Gait disturbance 179.66 34.30 103 5327 22442 2330213
Hypotension 173.80 34.30 115 5315 32321 2320334
Drug-induced liver injury 169.65 34.30 58 5372 3641 2349014
Amnesia 168.31 34.30 69 5361 7184 2345471
Nightmare 161.90 34.30 56 5374 3641 2349014
Overdose 158.69 34.30 91 5339 19816 2332839
Vomiting 157.26 34.30 150 5280 71452 2281203
Labelled drug-drug interaction medication error 152.47 34.30 42 5388 1266 2351389
Sleep disorder 151.46 34.30 62 5368 6427 2346228
Autoimmune hepatitis 150.48 34.30 44 5386 1651 2351004
Quality of life decreased 149.91 34.30 37 5393 716 2351939
Insomnia 146.76 34.30 95 5335 25692 2326963
Lymphatic fistula 146.29 34.30 21 5409 2 2352653
Muscle atrophy 146.10 34.30 39 5391 1041 2351614
Intentional overdose 144.83 34.30 71 5359 11250 2341405
Syncope 142.15 34.30 80 5350 16795 2335860
Femoral hernia incarcerated 141.43 34.30 21 5409 8 2352647
General physical health deterioration 141.14 34.30 75 5355 14064 2338591
Hepatic cyst 134.12 34.30 33 5397 630 2352025
Mobility decreased 133.23 34.30 62 5368 8748 2343907
International normalised ratio increased 131.08 34.30 58 5372 7278 2345377
Chest pain 129.77 34.30 91 5339 28046 2324609
Pancreatic steatosis 127.99 34.30 21 5409 34 2352621
Somnolence 127.42 34.30 84 5346 23401 2329254
Nausea 126.70 34.30 166 5264 112023 2240632
Diarrhoea 125.68 34.30 143 5287 83421 2269234
Hyperkalaemia 122.99 34.30 52 5378 5841 2346814
Aplastic anaemia 119.23 34.30 32 5398 872 2351783
Wound infection pseudomonas 118.62 34.30 21 5409 65 2352590
Urinary tract infection 117.91 34.30 88 5342 29854 2322801
Rash 117.88 34.30 118 5312 59440 2293215
Balance disorder 115.36 34.30 58 5372 9689 2342966
Blood cholesterol increased 115.24 34.30 48 5382 5193 2347462
Paraesthesia 114.96 34.30 77 5353 22011 2330644
Hyponatraemia 114.42 34.30 64 5366 13261 2339394
Pruritus 112.79 34.30 100 5330 43240 2309415
Arterial haemorrhage 112.75 34.30 23 5407 176 2352479
Feeling abnormal 112.74 34.30 78 5352 23503 2329152
Blood creatinine increased 111.11 34.30 58 5372 10475 2342180
Renal impairment 110.55 34.30 57 5373 10035 2342620
Carotid arteriosclerosis 110.45 34.30 22 5408 147 2352508
Necrotising myositis 110.16 34.30 19 5411 48 2352607
Product prescribing error 107.37 34.30 39 5391 2921 2349734
Tendon rupture 107.05 34.30 33 5397 1485 2351170
Back pain 107.04 34.30 85 5345 31574 2321081
Hyperhidrosis 105.72 34.30 64 5366 15358 2337297
Cutaneous T-cell dyscrasia 104.88 34.30 15 5415 1 2352654
Colitis microscopic 104.21 34.30 29 5401 907 2351748
Inflammatory marker increased 103.22 34.30 26 5404 548 2352107
Abdominal pain 102.97 34.30 86 5344 34288 2318367
Asphyxia 102.20 34.30 29 5401 975 2351680
Arteriosclerosis coronary artery 102.12 34.30 30 5400 1143 2351512
Cough 101.57 34.30 84 5346 33033 2319622
Cardio-respiratory arrest 101.16 34.30 52 5378 9094 2343561
Anuria 101.09 34.30 33 5397 1791 2350864
Chromaturia 98.84 34.30 36 5394 2717 2349938
Renal failure 98.79 34.30 64 5366 17285 2335370
Vision blurred 98.30 34.30 60 5370 14608 2338047
Peripheral swelling 97.96 34.30 64 5366 17533 2335122
Dyspepsia 97.55 34.30 52 5378 9792 2342863
Psychiatric symptom 96.58 34.30 27 5403 859 2351796
Gait inability 96.53 34.30 44 5386 5911 2346744
Tachyarrhythmia 95.42 34.30 25 5405 619 2352036
Aortic valve stenosis 95.00 34.30 22 5408 320 2352335
Seroma 94.34 34.30 21 5409 253 2352402
Gamma-glutamyltransferase increased 93.01 34.30 42 5388 5520 2347135
Aortic arteriosclerosis 91.15 34.30 24 5406 606 2352049
Haemarthrosis 90.20 34.30 22 5408 404 2352251
Decreased appetite 90.06 34.30 74 5356 28817 2323838
Haematuria 89.73 34.30 38 5392 4280 2348375
Memory impairment 89.50 34.30 54 5376 12869 2339786
Diverticulum intestinal 89.26 34.30 24 5406 658 2351997
Weight decreased 89.13 34.30 73 5357 28298 2324357
Myocardial depression 89.09 34.30 16 5414 55 2352600
Decorticate posture 89.05 34.30 15 5415 31 2352624
Lethargy 86.17 34.30 46 5384 8684 2343971
Liver injury 85.83 34.30 31 5399 2283 2350372
Respiratory arrest 85.74 34.30 41 5389 6137 2346518
Groin pain 85.35 34.30 27 5403 1323 2351332
Unresponsive to stimuli 85.29 34.30 38 5392 4838 2347817
Cognitive disorder 84.83 34.30 39 5391 5342 2347313
Pneumonia 83.60 34.30 90 5340 49206 2303449
Blood alkaline phosphatase increased 83.49 34.30 41 5389 6504 2346151
Anxiety 80.79 34.30 70 5360 29289 2323366
Wound dehiscence 79.26 34.30 22 5408 681 2351974
Left ventricular dysfunction 79.23 34.30 25 5405 1215 2351440
Pulmonary fibrosis 78.25 34.30 30 5400 2610 2350045
Acute hepatic failure 78.23 34.30 30 5400 2612 2350043
Polymyositis 77.99 34.30 19 5411 347 2352308
Cardiac arrest 77.49 34.30 52 5378 14878 2337777
Dysphagia 77.23 34.30 49 5381 12756 2339899
Blood lactate dehydrogenase increased 76.87 34.30 32 5398 3452 2349203
Muscle necrosis 76.42 34.30 16 5414 141 2352514
Anaemia 76.25 34.30 73 5357 34719 2317936
Hepatitis 75.79 34.30 38 5392 6299 2346356
Joint dislocation 75.28 34.30 25 5405 1431 2351224
Disturbance in attention 73.66 34.30 36 5394 5649 2347006
Abdominal distension 73.36 34.30 44 5386 10367 2342288
Escherichia infection 73.12 34.30 24 5406 1324 2351331
Tachycardia 73.05 34.30 52 5378 16357 2336298
Movement disorder 72.75 34.30 29 5401 2799 2349856
Eructation 72.47 34.30 23 5407 1139 2351516
Mitral valve incompetence 72.09 34.30 28 5402 2522 2350133
Sepsis 71.92 34.30 54 5376 18434 2334221
Jaundice 71.73 34.30 35 5395 5473 2347182
Transaminases increased 71.53 34.30 33 5397 4554 2348101
Electrocardiogram QT prolonged 71.05 34.30 39 5391 7775 2344880
Tremor 70.87 34.30 56 5374 20605 2332050
Abnormal loss of weight 70.68 34.30 20 5410 665 2351990
Collagen disorder 69.59 34.30 14 5416 99 2352556
Nodular rash 69.32 34.30 13 5417 60 2352595
Coronary artery disease 69.22 34.30 35 5395 5904 2346751
Faecaloma 69.22 34.30 21 5409 894 2351761
Urinary retention 68.71 34.30 30 5400 3637 2349018
Hypoglycaemia 68.38 34.30 39 5391 8368 2344287
Postoperative wound infection 67.73 34.30 22 5408 1174 2351481
Swollen tongue 66.73 34.30 33 5397 5310 2347345
Swelling face 66.56 34.30 40 5390 9453 2343202
Myocardial infarction 66.21 34.30 52 5378 18961 2333694
Gastrointestinal haemorrhage 66.18 34.30 44 5386 12391 2340264
Palpitations 66.08 34.30 49 5381 16407 2336248
Drug ineffective 65.35 34.30 116 5314 101508 2251147
Cardiac failure 64.86 34.30 43 5387 12051 2340604
Osteopenia 64.63 34.30 24 5406 1911 2350744
Self esteem decreased 64.47 34.30 14 5416 149 2352506
Alopecia 63.63 34.30 54 5376 21947 2330708
Angioedema 63.10 34.30 37 5393 8359 2344296
Hiatus hernia 62.90 34.30 24 5406 2060 2350595
Bradycardia 62.18 34.30 39 5391 9942 2342713
Cardiogenic shock 62.18 34.30 25 5405 2466 2350189
Acute respiratory distress syndrome 61.90 34.30 27 5403 3265 2349390
Enteritis 61.59 34.30 20 5410 1066 2351589
Abdominal discomfort 61.33 34.30 48 5382 17408 2335247
Hypertension 61.03 34.30 58 5372 27303 2325352
Suicide attempt 60.22 34.30 40 5390 11242 2341413
Cardiovascular disorder 60.05 34.30 24 5406 2331 2350324
Photosensitivity reaction 59.35 34.30 24 5406 2403 2350252
Abnormal dreams 59.05 34.30 24 5406 2434 2350221
Wrong patient received product 59.02 34.30 14 5416 227 2352428
Ventricular hypokinesia 58.96 34.30 17 5413 605 2352050
Visual impairment 58.73 34.30 40 5390 11715 2340940
Hypothermia 58.65 34.30 23 5407 2125 2350530
Linear IgA disease 58.54 34.30 15 5415 339 2352316
High density lipoprotein decreased 58.17 34.30 15 5415 348 2352307
Loss of personal independence in daily activities 58.12 34.30 30 5400 5281 2347374
Emotional distress 58.05 34.30 28 5402 4267 2348388
Pancreatitis acute 57.83 34.30 27 5403 3826 2348829
Tenderness 57.57 34.30 22 5408 1896 2350759
Hypoaesthesia 57.19 34.30 49 5381 20166 2332489
Tricuspid valve incompetence 57.00 34.30 21 5409 1635 2351020
Condition aggravated 56.98 34.30 60 5370 31919 2320736
Dehydration 56.97 34.30 51 5379 22244 2330411
Vertigo 56.78 34.30 36 5394 9348 2343307
Oesophagitis 56.61 34.30 22 5408 1984 2350671
Joint swelling 56.40 34.30 45 5385 16774 2335881
Pulmonary hypertension 56.27 34.30 29 5401 5089 2347566
Labile hypertension 55.95 34.30 11 5419 68 2352587
Poisoning 55.87 34.30 24 5406 2796 2349859
Postprandial hypoglycaemia 55.47 34.30 9 5421 13 2352642
Hypersensitivity pneumonitis 55.00 34.30 15 5415 434 2352221
Hepatic function abnormal 54.25 34.30 30 5400 6062 2346593
Blood urine present 54.06 34.30 21 5409 1891 2350764
Lichenoid keratosis 53.56 34.30 14 5416 343 2352312
Abdominal pain upper 53.41 34.30 49 5381 22051 2330604
Cold sweat 52.57 34.30 21 5409 2036 2350619
Left ventricular hypertrophy 52.42 34.30 16 5414 695 2351960
Subarachnoid haemorrhage 52.15 34.30 21 5409 2079 2350576
Vascular stent stenosis 51.93 34.30 11 5419 103 2352552
Impaired work ability 51.60 34.30 20 5410 1790 2350865
Cerebral haemorrhage 51.48 34.30 28 5402 5476 2347179
Myelodysplastic syndrome 51.42 34.30 22 5408 2538 2350117
Treatment noncompliance 51.34 34.30 28 5402 5506 2347149
Myoglobin blood increased 51.11 34.30 13 5417 285 2352370
Contraindicated product administered 51.08 34.30 23 5407 2998 2349657
Hepatotoxicity 51.03 34.30 24 5406 3457 2349198
Arterial stenosis 50.58 34.30 11 5419 118 2352537
Immobile 50.48 34.30 15 5415 594 2352061
Muscle twitching 49.79 34.30 22 5408 2743 2349912
Blood pressure abnormal 49.18 34.30 19 5411 1686 2350969
Pemphigus 48.94 34.30 15 5415 661 2351994
Muscle rupture 48.81 34.30 13 5417 343 2352312
Hypersensitivity 48.80 34.30 48 5382 23545 2329110
Drug abuse 48.69 34.30 36 5394 11990 2340665
Neuropathy, ataxia, retinitis pigmentosa syndrome 48.46 34.30 7 5423 1 2352654
Helicobacter gastritis 48.31 34.30 12 5418 238 2352417
C-reactive protein increased 48.14 34.30 28 5402 6227 2346428
Coma 48.06 34.30 32 5398 9024 2343631
Hepatic failure 47.89 34.30 27 5403 5662 2346993
Sopor 47.88 34.30 24 5406 3971 2348684
Social avoidant behaviour 47.35 34.30 14 5416 545 2352110
Intentional self-injury 47.14 34.30 24 5406 4103 2348552
Apolipoprotein A-I decreased 46.90 34.30 7 5423 3 2352652
Poor quality sleep 46.54 34.30 19 5411 1948 2350707
Pyrexia 46.17 34.30 70 5360 53638 2299017
Antineutrophil cytoplasmic antibody positive 46.00 34.30 10 5420 107 2352548
Muscle disorder 45.56 34.30 15 5415 835 2351820
Anal incontinence 44.97 34.30 18 5412 1754 2350901
Head injury 44.75 34.30 23 5407 4011 2348644
Blood albumin decreased 44.75 34.30 18 5412 1777 2350878
Toxic epidermal necrolysis 44.01 34.30 21 5409 3123 2349532
Blood bilirubin increased 44.00 34.30 25 5405 5320 2347335
Vasculitis 43.54 34.30 19 5411 2299 2350356
Acute coronary syndrome 43.45 34.30 17 5413 1560 2351095
Haemoglobin decreased 43.37 34.30 40 5390 18111 2334544
Musculoskeletal pain 42.90 34.30 32 5398 10798 2341857
Liver disorder 42.31 34.30 26 5404 6388 2346267
Loss of consciousness 42.23 34.30 40 5390 18727 2333928
Speech disorder 42.12 34.30 26 5404 6438 2346217
Muscle injury 41.79 34.30 11 5419 277 2352378
Neutrophil count abnormal 41.40 34.30 12 5418 435 2352220
Hepatomegaly 41.19 34.30 17 5413 1792 2350863
Hepatic enzyme increased 41.16 34.30 30 5400 9772 2342883
Impaired quality of life 41.07 34.30 10 5420 182 2352473
Diverticular perforation 40.86 34.30 12 5418 456 2352199
Restless legs syndrome 40.66 34.30 18 5412 2253 2350402
Dysarthria 40.18 34.30 25 5405 6277 2346378
Coronary artery thrombosis 39.98 34.30 11 5419 329 2352326
Lipohypertrophy 39.93 34.30 9 5421 115 2352540
Hypothyroidism 39.82 34.30 22 5408 4435 2348220
Hypercholesterolaemia 39.55 34.30 16 5414 1602 2351053
Illness anxiety disorder 39.47 34.30 8 5422 59 2352596
Accidental overdose 39.36 34.30 21 5409 3951 2348704
Pancreatitis 39.17 34.30 27 5403 8052 2344603
Chest discomfort 38.47 34.30 34 5396 14561 2338094
Impaired healing 38.43 34.30 23 5407 5388 2347267
Contusion 38.15 34.30 32 5398 12778 2339877
Heart rate increased 37.82 34.30 30 5400 11075 2341580
Interstitial lung disease 37.62 34.30 26 5404 7786 2344869
Burning sensation 37.58 34.30 26 5404 7802 2344853
Vascular injury 37.32 34.30 9 5421 157 2352498
Musculoskeletal stiffness 37.31 34.30 31 5399 12216 2340439
Tinnitus 36.92 34.30 22 5408 5113 2347542
Cerebral amyloid angiopathy 36.70 34.30 7 5423 36 2352619
Contraindicated product prescribed 36.51 34.30 8 5422 89 2352566
Weight increased 36.39 34.30 40 5390 22297 2330358
Cerebrovascular accident 36.14 34.30 38 5392 20148 2332507
Low density lipoprotein increased 36.13 34.30 14 5416 1252 2351403
Poliomyelitis 36.09 34.30 6 5424 11 2352644
Congestive cardiomyopathy 36.07 34.30 13 5417 950 2351705
White blood cell count abnormal 35.85 34.30 12 5418 703 2351952
Premature delivery 34.78 34.30 18 5412 3182 2349473
Eczema 34.76 34.30 18 5412 3187 2349468

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
Rhabdomyolysis 5644.86 33.63 1335 6053 9755 1729638
Myalgia 3325.22 33.63 946 6442 14712 1724681
Drug interaction 1930.32 33.63 724 6664 27234 1712159
Blood creatine phosphokinase increased 1815.38 33.63 524 6864 8332 1731061
Acute kidney injury 1707.75 33.63 705 6683 34239 1705154
Myopathy 1129.79 33.63 261 7127 1552 1737841
Muscular weakness 797.22 33.63 292 7096 9957 1729436
Completed suicide 630.04 33.63 281 7107 16031 1723362
Tendon rupture 569.03 33.63 150 7238 1622 1737771
Myositis 564.42 33.63 146 7242 1457 1737936
Asthenia 521.84 33.63 317 7071 34353 1705040
Pain in extremity 514.40 33.63 254 7134 18218 1721175
Muscle spasms 437.61 33.63 197 7191 11424 1727969
Alanine aminotransferase increased 374.67 33.63 180 7208 12098 1727295
Arthralgia 335.29 33.63 208 7180 23236 1716157
Liver function test abnormal 317.91 33.63 128 7260 5598 1733795
Chromaturia 307.24 33.63 102 7286 2548 1736845
Fatigue 297.84 33.63 263 7125 50518 1688875
Hepatic enzyme increased 283.47 33.63 123 7265 6498 1732895
Gait disturbance 278.77 33.63 149 7239 12521 1726872
Quality of life decreased 271.92 33.63 66 7322 492 1738901
Toxicity to various agents 252.94 33.63 190 7198 28951 1710442
Muscle rupture 234.68 33.63 57 7331 426 1738967
Aspartate aminotransferase increased 215.61 33.63 119 7269 10637 1728756
Fall 208.77 33.63 165 7223 27049 1712344
Blood creatinine increased 207.17 33.63 127 7261 13819 1725574
Psychiatric symptom 205.72 33.63 57 7331 749 1738644
Tenderness 205.34 33.63 60 7328 965 1738428
Balance disorder 200.84 33.63 93 7295 5719 1733674
Weight decreased 198.60 33.63 149 7239 22604 1716789
Muscle atrophy 187.77 33.63 58 7330 1137 1738256
Decreased appetite 177.11 33.63 142 7246 23729 1715664
Immune-mediated myositis 175.04 33.63 40 7348 221 1739172
Impaired work ability 174.78 33.63 54 7334 1059 1738334
Actinic keratosis 170.97 33.63 46 7342 537 1738856
Self esteem decreased 168.91 33.63 36 7352 135 1739258
Dyspnoea 165.35 33.63 194 7194 51865 1687528
Nightmare 163.85 33.63 65 7323 2722 1736671
Amnesia 161.92 33.63 76 7312 4815 1734578
Confusional state 160.82 33.63 128 7260 21150 1718243
Tendonitis 157.40 33.63 53 7335 1380 1738013
Drug hypersensitivity 156.68 33.63 110 7278 15025 1724368
Dermatomyositis 152.80 33.63 36 7352 232 1739161
Gait inability 152.04 33.63 65 7323 3298 1736095
Back pain 151.97 33.63 112 7276 16501 1722892
Hypotension 150.37 33.63 142 7246 29512 1709881
Jaundice 149.32 33.63 77 7311 5985 1733408
Pancreatitis acute 149.28 33.63 68 7320 4019 1735374
Renal failure 148.21 33.63 119 7269 19898 1719495
Haemodialysis 143.33 33.63 58 7330 2558 1736835
Pulmonary fibrosis 138.85 33.63 56 7332 2448 1736945
Paraesthesia 137.01 33.63 88 7300 10363 1729030
Hyperkalaemia 132.31 33.63 80 7308 8467 1730926
Social problem 130.77 33.63 30 7358 169 1739224
Nausea 130.57 33.63 171 7217 51025 1688368
Transaminases increased 130.03 33.63 61 7327 3856 1735537
Metabolic acidosis 128.38 33.63 67 7321 5335 1734058
Musculoskeletal pain 126.52 33.63 65 7323 5009 1734384
Hypoaesthesia 124.44 33.63 81 7307 9754 1729639
Dizziness 122.26 33.63 136 7252 34225 1705168
Frustration tolerance decreased 120.45 33.63 33 7355 414 1738979
Hepatitis 119.29 33.63 62 7326 4893 1734500
Lethargy 115.72 33.63 69 7319 7115 1732278
Interstitial lung disease 115.72 33.63 77 7311 9619 1729774
Rash 115.65 33.63 140 7248 38553 1700840
Malaise 115.56 33.63 123 7265 29442 1709951
Depression 114.68 33.63 95 7293 16574 1722819
Polyneuropathy 113.94 33.63 44 7344 1711 1737682
Pain 111.48 33.63 115 7273 26542 1712851
Diarrhoea 110.44 33.63 162 7226 53690 1685703
Basal cell carcinoma 108.94 33.63 47 7341 2436 1736957
Social avoidant behaviour 108.80 33.63 33 7355 606 1738787
Blood urea increased 107.85 33.63 57 7331 4654 1734739
Abdominal pain 107.04 33.63 102 7286 21388 1718005
Blood bilirubin increased 106.18 33.63 62 7326 6148 1733245
Hepatotoxicity 105.35 33.63 49 7339 3035 1736358
Mobility decreased 104.56 33.63 53 7335 3967 1735426
Loss of personal independence in daily activities 103.91 33.63 45 7343 2354 1737039
Dialysis 103.82 33.63 45 7343 2359 1737034
Oliguria 103.31 33.63 37 7351 1161 1738232
Insomnia 102.15 33.63 88 7300 16188 1723205
Myasthenia gravis 101.66 33.63 31 7357 580 1738813
Chest pain 100.07 33.63 95 7293 19819 1719574
Renal tubular necrosis 99.20 33.63 42 7346 2077 1737316
Cognitive disorder 98.01 33.63 52 7336 4278 1735115
Bowen's disease 97.52 33.63 26 7362 292 1739101
Drug-induced liver injury 97.01 33.63 47 7341 3190 1736203
Dehydration 94.01 33.63 87 7301 17571 1721822
Irritability 93.96 33.63 55 7333 5477 1733916
Erectile dysfunction 93.38 33.63 51 7337 4446 1734947
Compartment syndrome 91.96 33.63 28 7360 521 1738872
Intentional overdose 91.70 33.63 61 7327 7609 1731784
Naevus flammeus 89.66 33.63 17 7371 28 1739365
Renal impairment 88.44 33.63 72 7316 12242 1727151
Cough 87.82 33.63 87 7301 19110 1720283
Oedema peripheral 87.41 33.63 79 7309 15471 1723922
Overdose 86.41 33.63 81 7307 16620 1722773
Dyspnoea exertional 85.87 33.63 47 7341 4114 1735279
Hepatomegaly 84.23 33.63 35 7353 1650 1737743
Myoglobin blood increased 83.35 33.63 25 7363 441 1738952
Personality change 83.07 33.63 31 7357 1095 1738298
Polymyositis 80.00 33.63 22 7366 280 1739113
Memory impairment 79.66 33.63 53 7335 6610 1732783
Myoglobinuria 78.61 33.63 20 7368 184 1739209
Necrotising myositis 78.04 33.63 16 7372 47 1739346
Muscle necrosis 78.03 33.63 20 7368 190 1739203
Labelled drug-drug interaction medication error 77.59 33.63 31 7357 1320 1738073
White blood cell count increased 77.53 33.63 54 7334 7258 1732135
Pruritus 77.47 33.63 89 7299 23133 1716260
Potentiating drug interaction 76.67 33.63 26 7362 691 1738702
Abdominal distension 76.41 33.63 51 7337 6393 1733000
Dysphagia 76.28 33.63 61 7327 10107 1729286
Dysstasia 76.27 33.63 33 7355 1721 1737672
Aggression 74.72 33.63 55 7333 8060 1731333
Liver injury 74.03 33.63 33 7355 1849 1737544
Abnormal dreams 73.88 33.63 33 7355 1858 1737535
Skin cancer 73.53 33.63 30 7358 1349 1738044
Quadriparesis 73.50 33.63 20 7368 244 1739149
Myopathy toxic 73.18 33.63 17 7371 102 1739291
General physical health deterioration 72.43 33.63 66 7322 13052 1726341
Inhibitory drug interaction 72.19 33.63 20 7368 262 1739131
Discomfort 72.19 33.63 36 7352 2600 1736793
Alveolitis 72.09 33.63 21 7367 333 1739060
Headache 69.66 33.63 103 7285 34273 1705120
Cholestasis 69.06 33.63 39 7349 3626 1735767
Abdominal pain upper 67.98 33.63 59 7329 10942 1728451
Pancreatitis necrotising 67.97 33.63 21 7367 411 1738982
Blood potassium increased 67.66 33.63 34 7354 2496 1736897
Drug intolerance 67.15 33.63 46 7342 6016 1733377
Neck pain 66.63 33.63 37 7351 3329 1736064
Hepatitis acute 65.84 33.63 27 7361 1230 1738163
Cerebrovascular accident 65.58 33.63 72 7316 17794 1721599
Loss of consciousness 65.38 33.63 66 7322 14809 1724584
Movement disorder 64.78 33.63 29 7359 1641 1737752
Blood alkaline phosphatase increased 63.72 33.63 42 7346 5153 1734240
Suicide attempt 63.42 33.63 48 7340 7333 1732060
Contraindicated product administered 62.23 33.63 27 7361 1417 1737976
Gamma-glutamyltransferase increased 62.01 33.63 41 7347 5057 1734336
Hepatitis cholestatic 61.21 33.63 26 7362 1295 1738098
Lichen planus 60.72 33.63 17 7371 232 1739161
Oesophageal obstruction 59.30 33.63 14 7374 91 1739302
Acute hepatic failure 59.20 33.63 29 7359 2014 1737379
Bezoar 59.15 33.63 15 7373 136 1739257
Musculoskeletal stiffness 59.03 33.63 42 7346 5834 1733559
Swelling 59.01 33.63 45 7343 6951 1732442
Vomiting 57.31 33.63 100 7288 38215 1701178
Dermatitis exfoliative 57.04 33.63 26 7362 1535 1737858
Acute respiratory distress syndrome 56.86 33.63 34 7354 3517 1735876
Lichenoid keratosis 56.80 33.63 18 7370 384 1739009
Myelofibrosis 56.45 33.63 18 7370 392 1739001
Haematuria 55.92 33.63 45 7343 7515 1731878
Pancreatitis 55.77 33.63 44 7344 7143 1732250
Angina pectoris 55.38 33.63 38 7350 4980 1734413
Anuria 55.31 33.63 27 7361 1861 1737532
Syncope 55.30 33.63 59 7329 14110 1725283
Gout 55.20 33.63 30 7358 2586 1736807
Acute myocardial infarction 54.96 33.63 47 7341 8540 1730853
Wrong patient received product 54.75 33.63 15 7373 188 1739205
Pyrexia 54.30 33.63 109 7279 46291 1693102
Sepsis 54.12 33.63 68 7320 19370 1720023
Amyotrophic lateral sclerosis 53.94 33.63 16 7372 271 1739122
Suicidal ideation 53.25 33.63 46 7342 8472 1730921
Granuloma annulare 52.08 33.63 11 7377 39 1739354
Palpitations 51.33 33.63 41 7347 6773 1732620
Contusion 51.15 33.63 37 7351 5272 1734121
Swollen tongue 50.52 33.63 29 7359 2779 1736614
Faeces pale 50.52 33.63 15 7373 255 1739138
Hyperhidrosis 50.50 33.63 53 7335 12435 1726958
Oesophageal perforation 50.30 33.63 13 7375 128 1739265
International normalised ratio increased 50.23 33.63 44 7344 8255 1731138
Thrombotic thrombocytopenic purpura 50.19 33.63 19 7369 698 1738695
Precancerous skin lesion 49.50 33.63 13 7375 137 1739256
Pollakiuria 49.23 33.63 29 7359 2917 1736476
Disturbance in attention 48.95 33.63 33 7355 4201 1735192
Somnolence 48.90 33.63 60 7328 16679 1722714
Myocardial infarction 48.75 33.63 77 7311 27097 1712296
Actinic elastosis 48.18 33.63 9 7379 13 1739380
Condition aggravated 48.09 33.63 67 7321 21083 1718310
Bradycardia 46.74 33.63 47 7341 10487 1728906
Muscle disorder 46.52 33.63 17 7371 565 1738828
Feeling abnormal 46.24 33.63 48 7340 11118 1728275
Blood urine present 45.77 33.63 24 7364 1924 1737469
Atrial fibrillation 45.49 33.63 55 7333 15056 1724337
Mitochondrial myopathy 45.44 33.63 10 7378 45 1739348
Areflexia 44.93 33.63 16 7372 493 1738900
Cardiac failure 44.85 33.63 50 7338 12552 1726841
Cardiac arrest 44.76 33.63 56 7332 15874 1723519
Diabetes mellitus 44.58 33.63 38 7350 6870 1732523
Neutrophil count increased 44.58 33.63 26 7362 2567 1736826
Tinnitus 44.53 33.63 28 7360 3167 1736226
Peripheral coldness 44.23 33.63 20 7368 1158 1738235
Splenomegaly 43.86 33.63 24 7364 2096 1737297
Hepatic function abnormal 43.80 33.63 38 7350 7036 1732357
Hyperlipidaemia 42.74 33.63 24 7364 2205 1737188
Guillain-Barre syndrome 42.39 33.63 18 7370 895 1738498
Neuromyopathy 42.31 33.63 12 7376 172 1739221
Muscle contractions involuntary 41.88 33.63 15 7373 470 1738923
Paralysis 41.60 33.63 20 7368 1332 1738061
Ejaculation failure 41.17 33.63 14 7374 375 1739018
Depressed mood 40.95 33.63 26 7362 2990 1736403
Musculoskeletal discomfort 40.66 33.63 18 7370 991 1738402
Abnormal loss of weight 40.64 33.63 15 7373 513 1738880
Hypercholesterolaemia 40.57 33.63 19 7369 1193 1738200
Blood pressure increased 40.57 33.63 44 7344 10709 1728684
Pneumonia 39.81 33.63 96 7292 46086 1693307
Coordination abnormal 39.67 33.63 20 7368 1477 1737916
Flatulence 39.11 33.63 25 7363 2909 1736484
Coma scale abnormal 38.80 33.63 15 7373 584 1738809
Liver disorder 38.42 33.63 32 7356 5604 1733789
Sleep disorder 38.41 33.63 28 7360 4035 1735358
Colitis microscopic 38.06 33.63 13 7375 353 1739040
Hepatitis E 37.95 33.63 12 7376 254 1739139
Hyponatraemia 37.81 33.63 39 7349 8961 1730432
Respiratory failure 37.60 33.63 49 7339 14456 1724937
Impatience 37.52 33.63 10 7378 112 1739281
Lower respiratory tract infection 37.46 33.63 27 7361 3824 1735569
Burning feet syndrome 37.11 33.63 7 7381 11 1739382
Hypokalaemia 36.97 33.63 33 7355 6341 1733052
Drug eruption 36.70 33.63 24 7364 2902 1736491
Occupational problem environmental 36.55 33.63 6 7382 1 1739392
Cerebral infarction 36.39 33.63 30 7358 5179 1734214
Mood altered 35.74 33.63 21 7367 2101 1737292
Hepatic necrosis 35.71 33.63 15 7373 726 1738667
Electrocardiogram ST segment elevation 35.49 33.63 16 7372 920 1738473
Induration 35.46 33.63 11 7377 218 1739175
Ocular myasthenia 35.18 33.63 8 7380 43 1739350
Neuropathy peripheral 35.14 33.63 38 7350 9215 1730178
Blood albumin decreased 35.04 33.63 19 7369 1629 1737764
Low density lipoprotein increased 34.96 33.63 16 7372 953 1738440
Limb discomfort 34.66 33.63 18 7370 1414 1737979
Blood pH decreased 34.46 33.63 13 7375 473 1738920
Avoidant personality disorder 34.41 33.63 6 7382 4 1739389
Hepatic steatosis 34.39 33.63 22 7366 2562 1736831
Periarthritis 34.18 33.63 10 7378 161 1739232
Haemoptysis 33.89 33.63 28 7360 4848 1734545
PCO2 decreased 33.88 33.63 11 7377 254 1739139
Mitochondrial myopathy acquired 33.84 33.63 6 7382 5 1739388
Bursitis 33.84 33.63 14 7374 652 1738741
Tendon disorder 33.70 33.63 13 7375 503 1738890

Pharmacologic Action:

SourceCodeDescription
ATC C10AA01 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
HMG CoA reductase inhibitors
ATC A10BH51 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Dipeptidyl peptidase 4 (DPP-4) inhibitors
ATC C10BA02 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors in combination with other lipid modifying agents
ATC C10BA04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors in combination with other lipid modifying agents
ATC C10BX01 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
ATC C10BX04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
HMG CoA reductase inhibitors, other combinations
FDA EPC N0000175589 HMG-CoA Reductase Inhibitor
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019161 Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:50266 prodrug

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Arteriosclerotic vascular disease indication 72092001
Hypoalphalipoproteinemia indication 190785000
Cerebrovascular accident indication 230690007
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006
Familial type 3 hyperlipoproteinemia indication 398796005 DOID:3145
Prevention of Transient Ischemic Attacks indication
Myocardial Infarction Prevention indication
Slow Progression of Coronary Artery Disease indication
Myocardial Reinfarction Prevention off-label use
Primary Prevention of Coronary Heart Disease off-label use
Hypophosphatemia contraindication 4996001
Alcoholism contraindication 7200002
Peptic ulcer contraindication 13200003 DOID:750
Myocardial infarction contraindication 22298006 DOID:5844
Low blood pressure contraindication 45007003
Acute nephropathy contraindication 58574008
Blood coagulation disorder contraindication 64779008 DOID:1247
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Gout contraindication 90560007 DOID:13189
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Hemorrhagic cerebral infarction contraindication 230706003
Arterial hemorrhage contraindication 234003006
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Surgical procedure contraindication 387713003
Acute coronary syndrome contraindication 394659003
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myopathy related to SLCO1B1 Gene Variant contraindication
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance contraindication

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 8168637 June 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
20MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 6699871 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
40MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7125873 July 26, 2022 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
10MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
20MG JUVISYNC MERCK SHARP DOHME N202343 Oct. 7, 2011 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
40MG JUVISYNC MERCK SHARP DOHME N202343 Sept. 18, 2012 DISCN TABLET ORAL 7326708 April 11, 2026 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme INHIBITOR IC50 7.77 WOMBAT-PK CHEMBL
Nuclear receptor subfamily 1 group I member 3 Nuclear hormone receptor WOMBAT-PK
3-hydroxy-3-methylglutaryl-coenzyme A reductase Unclassified IC50 4.02 CHEMBL
Acetylcholinesterase Enzyme Ki 5.74 CHEMBL
Cholinesterase Enzyme Ki 6.12 CHEMBL
3-hydroxy-3-methylglutaryl-coenzyme A reductase Enzyme IC50 8.37 CHEMBL

External reference:

IDSource
4020400 VUID
N0000148200 NUI
C0074554 UMLSCUI
D00434 KEGG_DRUG
96304005 SNOMEDCT_US
4020400 VANDF
82969 MMSL
003621 NDDF
36567 RXNORM
387584000 SNOMEDCT_US
5465 MMSL
d00746 MMSL
AGG2FN16EV UNII
6147 INN_ID
CHEMBL1064 ChEMBL_ID
DB00641 DRUGBANK_ID
CHEBI:9150 CHEBI
D019821 MESH_DESCRIPTOR_UI
54454 PUBCHEM_CID
2955 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0543 TABLET, FILM COATED 80 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0726 TABLET, FILM COATED 5 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0735 TABLET, FILM COATED 10 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0740 TABLET, FILM COATED 20 mg ORAL NDA 18 sections
ZOCOR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0749 TABLET, FILM COATED 40 mg ORAL NDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7152 TABLET, FILM COATED 5 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7153 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7154 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7155 TABLET, FILM COATED 40 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0093-7156 TABLET, FILM COATED 80 mg ORAL ANDA 16 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1385 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1386 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1387 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 0115-1388 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6579 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6580 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6581 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6587 TABLET, FILM COATED 5 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-6588 TABLET, FILM COATED 80 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7704 TABLET, FILM COATED 5 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7705 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7706 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 0615-7707 TABLET, FILM COATED 40 mg ORAL ANDA 17 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-7992 TABLET, FILM COATED 10 mg ORAL ANDA 16 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-7993 TABLET, FILM COATED 20 mg ORAL ANDA 16 sections
SIMVASTATIN HUMAN PRESCRIPTION DRUG LABEL 1 0615-8056 TABLET, FILM COATED 40 mg ORAL ANDA 16 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-486 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
Simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-487 TABLET, FILM COATED 40 mg ORAL ANDA 18 sections
simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-907 TABLET, FILM COATED 80 mg ORAL ANDA 17 sections
simvastatin HUMAN PRESCRIPTION DRUG LABEL 1 10544-908 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections