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

Stem definitionDrug idCAS RN
antihyperlipidaemics, acyl CoA: cholesterol acyltransferase (ACAT) inhibitors 1125 163222-33-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • SCH58235
  • SCH-58235
  • ezetimib
  • ezetimibe
  • ezedoc
  • ezentia
  • ezetrol
  • zetia
An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.
  • Molecular weight: 409.43
  • Formula: C24H21F2NO3
  • CLOGP: 3.96
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 60.77
  • ALOGS: -4.68
  • ROTB: 6
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.35 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 0.01 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Oct. 25, 2002 FDA MSD INTL GMBH
April 18, 2007 PMDA Schering-Plough K.K

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
Myalgia 1057.60 10.64 1020 66512 145509 63275981
Rhabdomyolysis 679.06 10.64 477 67055 43474 63378016
Blood creatine phosphokinase increased 396.43 10.64 298 67234 30132 63391358
Low density lipoprotein increased 232.00 10.64 120 67412 6237 63415253
Contraindicated product administered 175.81 10.64 15 67517 217633 63203857
Muscle spasms 173.28 10.64 458 67074 155692 63265798
Pemphigus 168.79 10.64 6 67526 183720 63237770
Maternal exposure during pregnancy 160.39 10.64 22 67510 220040 63201450
Coronary artery disease 148.97 10.64 178 67354 32199 63389291
Angina pectoris 132.89 10.64 162 67370 29916 63391574
Synovitis 128.62 10.64 22 67510 186896 63234594
Drug ineffective 127.78 10.64 626 66906 1044139 62377351
Wound 127.15 10.64 13 67519 163250 63258240
Myocardial infarction 125.28 10.64 307 67225 99586 63321904
Pericarditis 121.88 10.64 4 67528 131575 63289915
Muscular weakness 116.01 10.64 339 67193 122014 63299476
Glossodynia 112.72 10.64 26 67506 178850 63242640
Off label use 111.53 10.64 358 67174 674104 62747386
Myopathy 110.14 10.64 93 67439 11098 63410392
Product use issue 105.99 10.64 51 67481 220469 63201021
Systemic lupus erythematosus 104.00 10.64 46 67486 208872 63212618
Pancreatitis acute 99.02 10.64 133 67399 27033 63394457
Infusion related reaction 97.95 10.64 71 67461 245450 63176040
Coronary artery occlusion 95.20 10.64 75 67457 8116 63413374
Liver function test abnormal 92.51 10.64 176 67356 48005 63373485
Toxicity to various agents 91.67 10.64 77 67455 247173 63174317
Dyslipidaemia 86.58 10.64 68 67464 7325 63414165
Therapeutic product effect decreased 82.21 10.64 52 67480 193135 63228355
Hyper IgE syndrome 79.05 10.64 27 67505 483 63421007
Pain in extremity 76.90 10.64 609 66923 330877 63090613
Duodenal ulcer perforation 76.25 10.64 4 67528 87205 63334285
Arterial occlusive disease 72.37 10.64 56 67476 5902 63415588
Flatulence 71.91 10.64 131 67401 34571 63386919
Treatment failure 70.12 10.64 65 67467 198978 63222512
Pancreatitis 68.21 10.64 157 67375 48898 63372592
Exposure during pregnancy 65.98 10.64 42 67490 155505 63265985
Helicobacter infection 65.86 10.64 10 67522 92775 63328715
Folliculitis 62.19 10.64 3 67529 70314 63351176
Swelling 60.83 10.64 126 67406 275252 63146238
Infection 58.47 10.64 96 67436 229077 63192413
Gangrene 56.41 10.64 49 67483 6074 63415416
Carotid arteriosclerosis 55.67 10.64 26 67506 1080 63420410
Restrictive pulmonary disease 54.55 10.64 30 67502 1765 63419725
Inhibitory drug interaction 53.67 10.64 35 67497 2814 63418676
Body tinea 53.18 10.64 30 67502 1855 63419635
Neutropenia 50.79 10.64 67 67465 174938 63246552
Asthenia 49.89 10.64 625 66907 382979 63038511
Death 49.72 10.64 217 67315 374164 63047326
Blood glucose increased 49.31 10.64 198 67334 83558 63337932
High density lipoprotein decreased 49.26 10.64 30 67502 2140 63419350
Cerebrovascular accident 48.87 10.64 236 67296 107788 63313702
Polymyositis 48.80 10.64 28 67504 1788 63419702
Vascular stent stenosis 47.62 10.64 19 67513 534 63420956
Acute kidney injury 47.49 10.64 458 67074 262957 63158533
Pulmonary pain 47.25 10.64 35 67497 3455 63418035
Joint swelling 46.56 10.64 185 67347 327481 63094009
Muscle injury 46.47 10.64 7 67525 65338 63356152
Completed suicide 46.25 10.64 52 67480 145621 63275869
Aspartate aminotransferase increased 45.83 10.64 204 67328 90073 63331417
Palpitations 45.82 10.64 239 67293 112531 63308959
Alopecia 45.82 10.64 194 67338 337342 63084148
Blood triglycerides increased 45.29 10.64 61 67471 12427 63409063
Immune-mediated myositis 45.15 10.64 24 67508 1319 63420171
Myopathy toxic 44.91 10.64 18 67514 512 63420978
Discomfort 44.68 10.64 68 67464 167306 63254184
Hyperlipidaemia 44.56 10.64 77 67455 19494 63401996
Alanine aminotransferase increased 44.30 10.64 223 67309 103547 63317943
Intentional product use issue 43.58 10.64 43 67489 127849 63293641
Dizziness 42.39 10.64 667 66865 429258 62992232
Acute coronary syndrome 42.24 10.64 53 67479 10073 63411417
Glucose tolerance impaired 42.09 10.64 43 67489 6534 63414956
Muscle discomfort 40.81 10.64 13 67519 185 63421305
Cardiac failure congestive 40.42 10.64 200 67332 92233 63329257
Coombs positive haemolytic anaemia 39.96 10.64 15 67517 356 63421134
Febrile neutropenia 39.02 10.64 41 67491 118408 63303082
Muscle rupture 38.81 10.64 27 67505 2416 63419074
Antinuclear antibody negative 38.67 10.64 13 67519 221 63421269
Skin disorder 38.35 10.64 92 67440 29415 63392075
Infection susceptibility increased 38.27 10.64 31 67501 3490 63418000
Amyloid arthropathy 36.71 10.64 16 67516 564 63420926
Acute myocardial infarction 36.34 10.64 95 67437 32029 63389461
Sensorimotor disorder 36.04 10.64 15 67517 471 63421019
Chest pain 35.75 10.64 369 67163 215590 63205900
Arthropathy 35.63 10.64 129 67403 234663 63186827
Fall 34.69 10.64 598 66934 391736 63029754
Endocrine ophthalmopathy 34.47 10.64 16 67516 655 63420835
Coronary artery stenosis 34.02 10.64 33 67499 4711 63416779
Irritable bowel syndrome 33.92 10.64 23 67509 82389 63339101
Blister 33.44 10.64 54 67478 129760 63291730
Crush syndrome 33.03 10.64 10 67522 119 63421371
C-reactive protein abnormal 32.63 10.64 5 67527 46091 63375399
Disease progression 31.68 10.64 51 67481 122707 63298783
Intentional overdose 31.46 10.64 20 67512 74132 63347358
Drug interaction 31.31 10.64 377 67155 228754 63192736
Toxic shock syndrome 31.02 10.64 16 67516 826 63420664
Rhinalgia 31.00 10.64 20 67512 1579 63419911
Psoriatic arthropathy 30.91 10.64 31 67501 91489 63330001
Cataract 30.53 10.64 131 67401 56922 63364568
Gastrooesophageal reflux disease 30.48 10.64 190 67342 95449 63326041
Pyrexia 30.39 10.64 337 67195 470141 62951349
Carotid artery thrombosis 29.11 10.64 24 67508 2770 63418720
Stomatitis 28.51 10.64 66 67466 138659 63282831
Myoglobin blood increased 28.29 10.64 18 67514 1387 63420103
Blood pressure increased 28.29 10.64 280 67252 161782 63259708
Vulvovaginal burning sensation 28.21 10.64 21 67511 2088 63419402
Polycystic ovaries 28.19 10.64 29 67503 4442 63417048
Neurologic neglect syndrome 27.57 10.64 23 67509 2698 63418792
Sinus congestion 27.42 10.64 60 67472 18063 63403427
Muscle disorder 27.38 10.64 30 67502 4939 63416551
Back pain 27.19 10.64 413 67119 263732 63157758
Arterial stenosis 26.84 10.64 13 67519 586 63420904
Nasal discomfort 26.68 10.64 29 67503 4731 63416759
Gastric disorder 26.68 10.64 94 67438 37275 63384215
Purpura 26.19 10.64 45 67487 11340 63410150
Impaired healing 26.08 10.64 43 67489 102499 63318991
Myositis 25.90 10.64 40 67492 9226 63412264
Lipids increased 25.77 10.64 16 67516 1181 63420309
Aortic stenosis 25.42 10.64 29 67503 4991 63416499
Oral herpes 25.40 10.64 73 67459 26001 63395489
Chest discomfort 25.39 10.64 202 67330 109767 63311723
Microscopic polyangiitis 25.32 10.64 9 67523 182 63421308
Coma acidotic 25.23 10.64 8 67524 112 63421378
Intervertebral disc degeneration 24.85 10.64 53 67479 15679 63405811
Herpes simplex reactivation 24.47 10.64 12 67520 556 63420934
Restless legs syndrome 24.32 10.64 58 67474 18473 63403017
Product use in unapproved indication 24.21 10.64 103 67429 178977 63242513
Nasal dryness 24.11 10.64 27 67505 4554 63416936
Pregnancy 23.90 10.64 5 67527 36831 63384659
Eyelid disorder 23.82 10.64 18 67514 1831 63419659
Chromaturia 23.78 10.64 54 67478 16663 63404827
Lipoprotein (a) increased 23.17 10.64 6 67526 38 63421452
Vascular purpura 22.70 10.64 16 67516 1462 63420028
Poor quality sleep 22.59 10.64 59 67473 19876 63401614
Impaired quality of life 22.42 10.64 47 67485 13736 63407754
Nasal ulcer 22.37 10.64 19 67513 2285 63419205
Cerebrovascular arteriovenous malformation 22.35 10.64 7 67525 94 63421396
Gastritis haemorrhagic 22.06 10.64 16 67516 1529 63419961
Rheumatoid arthritis 21.89 10.64 169 67363 253650 63167840
Sedation 21.87 10.64 7 67525 38802 63382688
Necrotising myositis 21.73 10.64 11 67521 546 63420944
Renovascular hypertension 21.62 10.64 5 67527 18 63421472
Fibromyalgia 21.13 10.64 33 67499 80387 63341103
Copper metabolism disorder 20.62 10.64 4 67528 4 63421486
Nausea 20.47 10.64 1107 66425 853364 62568126
Transient ischaemic attack 20.43 10.64 87 67445 37666 63383824
Vulvovaginal pruritus 20.38 10.64 21 67511 3222 63418268
Device expulsion 20.21 10.64 6 67526 34916 63386574
Pancytopenia 20.00 10.64 46 67486 96887 63324603
Blood pressure systolic abnormal 19.89 10.64 44 67488 13342 63408148
Sleep apnoea syndrome 19.70 10.64 72 67460 29061 63392429
Abnormal dreams 19.66 10.64 38 67494 10478 63411012
Hypersensitivity 19.52 10.64 208 67324 292477 63129013
Peripheral swelling 19.39 10.64 185 67347 265757 63155733
Biliary fibrosis 19.35 10.64 4 67528 7 63421483
Language disorder 19.32 10.64 17 67515 2143 63419347
Coronary artery thrombosis 19.06 10.64 13 67519 1126 63420364
Angina unstable 18.95 10.64 30 67502 7065 63414425
Diabetic neuropathy 18.56 10.64 22 67510 3942 63417548
Paranasal sinus discomfort 18.40 10.64 23 67509 4353 63417137
Carotid artery stenosis 18.36 10.64 25 67507 5145 63416345
Therapy non-responder 18.23 10.64 33 67499 75868 63345622
Condition aggravated 18.07 10.64 310 67222 401907 63019583
Palmar erythema 18.04 10.64 15 67517 1752 63419738
Suicide attempt 17.99 10.64 23 67509 60895 63360595
Therapy cessation 17.91 10.64 72 67460 30385 63391105
Blood glucose decreased 17.89 10.64 56 67476 20896 63400594
Drug ineffective for unapproved indication 17.73 10.64 7 67525 34056 63387434
Pain 17.62 10.64 628 66904 740000 62681490
Mobility decreased 17.43 10.64 68 67464 121091 63300399
Bone density decreased 17.34 10.64 44 67488 14568 63406922
Ischaemic cardiomyopathy 17.33 10.64 17 67515 2460 63419030
Gait disturbance 17.16 10.64 282 67250 182896 63238594
Impaired work ability 17.09 10.64 49 67483 17426 63404064
Electrocardiogram QT prolonged 17.04 10.64 23 67509 59507 63361983
Bone marrow failure 17.01 10.64 5 67527 29285 63392205
Spleen congestion 16.99 10.64 6 67526 119 63421371
Encephalopathy 16.96 10.64 10 67522 38610 63382880
Spontaneous haematoma 16.89 10.64 11 67521 882 63420608
Nasopharyngitis 16.82 10.64 181 67351 254076 63167414
Depressed level of consciousness 16.76 10.64 25 67507 62053 63359437
Sensory loss 16.76 10.64 35 67497 10203 63411287
Cardiac failure chronic 16.66 10.64 22 67510 4396 63417094
Drug dependence 16.56 10.64 3 67529 24480 63397010
Chronic spontaneous urticaria 16.56 10.64 12 67520 1145 63420345
Low density lipoprotein abnormal 16.55 10.64 7 67525 229 63421261
Transferrin decreased 16.27 10.64 7 67525 239 63421251
Aortic arteriosclerosis 16.24 10.64 26 67506 6183 63415307
Complex regional pain syndrome 16.16 10.64 16 67516 2341 63419149
Hyperparathyroidism secondary 16.12 10.64 13 67519 1454 63420036
Anembryonic gestation 15.96 10.64 9 67523 556 63420934
Respiratory disorder 15.95 10.64 11 67521 39071 63382419
Weight decreased 15.87 10.64 396 67136 276402 63145088
Myelosuppression 15.83 10.64 3 67529 23700 63397790
Cystitis noninfective 15.73 10.64 11 67521 992 63420498
Device dislocation 15.66 10.64 4 67528 25701 63395789
Intentional self-injury 15.64 10.64 4 67528 25683 63395807
Gingival oedema 15.45 10.64 5 67527 75 63421415
Glycosylated haemoglobin increased 15.41 10.64 38 67494 12360 63409130
Malignant neoplasm progression 15.36 10.64 41 67491 82080 63339410
Hypoglycaemia 15.34 10.64 113 67419 59952 63361538
Toxic epidermal necrolysis 15.32 10.64 4 67528 25330 63396160
Disease risk factor 15.16 10.64 5 67527 80 63421410
Muscle atrophy 15.14 10.64 27 67505 7006 63414484
C-reactive protein increased 15.04 10.64 51 67481 94656 63326834
Platelet count decreased 14.95 10.64 68 67464 116054 63305436
Hyperphosphataemia 14.94 10.64 15 67517 2233 63419257
Mean cell haemoglobin increased 14.90 10.64 17 67515 2926 63418564
Photopsia 14.81 10.64 21 67511 4488 63417002
Helicobacter gastritis 14.77 10.64 13 67519 1639 63419851
Personality disorder 14.74 10.64 24 67508 5787 63415703
Heliotrope rash 14.64 10.64 6 67526 181 63421309
Cognitive disorder 14.57 10.64 23 67509 55792 63365698
Cholestasis 14.54 10.64 66 67466 29368 63392122
Hip fracture 14.49 10.64 66 67466 29408 63392082
Haematochezia 14.41 10.64 102 67430 53442 63368048
Depression 14.37 10.64 291 67241 196201 63225289
Low density lipoprotein 14.25 10.64 3 67529 6 63421484
Iron binding capacity total decreased 14.14 10.64 7 67525 331 63421159
Hip arthroplasty 14.06 10.64 18 67514 47628 63373862
Hepatic cyst 14.05 10.64 22 67510 5132 63416358
Sneezing 14.03 10.64 47 67485 18171 63403319
Blood creatine phosphokinase MM increased 14.02 10.64 4 67528 38 63421452
Blood cholesterol decreased 13.99 10.64 10 67522 934 63420556
Vascular access site pain 13.98 10.64 5 67527 103 63421387
Swelling of eyelid 13.94 10.64 17 67515 3139 63418351
Cerebellar syndrome 13.93 10.64 18 67514 3521 63417969
Antiphospholipid syndrome 13.88 10.64 13 67519 1777 63419713
Hepatic steatosis 13.83 10.64 64 67468 28705 63392785
Arteriosclerosis 13.75 10.64 32 67500 10034 63411456
Abscess 13.73 10.64 44 67488 16624 63404866
Ill-defined disorder 13.69 10.64 43 67489 81712 63339778
Skin haemorrhage 13.69 10.64 32 67500 10062 63411428
Paranoia 13.68 10.64 35 67497 11644 63409846
Sepsis 13.64 10.64 101 67431 153022 63268468
Skin laceration 13.61 10.64 54 67478 22654 63398836
Blood test abnormal 13.56 10.64 42 67490 15587 63405903
Aphthous ulcer 13.55 10.64 39 67493 13899 63407591
Urinary tract infection 13.53 10.64 373 67159 264311 63157179
Poikiloderma 13.47 10.64 6 67526 223 63421267
Euglycaemic diabetic ketoacidosis 13.40 10.64 18 67514 3656 63417834
Hypocholesterolaemia 13.39 10.64 5 67527 117 63421373
Muscle fatigue 13.30 10.64 15 67517 2549 63418941
Hemiplegia 13.13 10.64 30 67502 9293 63412197
Low density lipoprotein decreased 13.10 10.64 6 67526 238 63421252
Arteriosclerosis coronary artery 12.98 10.64 28 67504 8345 63413145
Joint space narrowing 12.97 10.64 8 67524 584 63420906
Lower respiratory tract infection 12.90 10.64 85 67447 132222 63289268
Hemiparesis 12.87 10.64 54 67478 23228 63398262
Total cholesterol/HDL ratio decreased 12.73 10.64 3 67529 12 63421478
Obstructive pancreatitis 12.66 10.64 7 67525 416 63421074
Septic shock 12.66 10.64 33 67499 66596 63354894
Acquired epidermolysis bullosa 12.62 10.64 4 67528 56 63421434
Grip strength decreased 12.59 10.64 4 67528 22283 63399207
Hallucination, auditory 12.58 10.64 36 67496 12788 63408702
Nasal cyst 12.49 10.64 4 67528 58 63421432
Small intestinal haemorrhage 12.17 10.64 13 67519 2079 63419411
Lipids abnormal 12.06 10.64 6 67526 287 63421203
Radius fracture 12.04 10.64 17 67515 3618 63417872
Pancreatitis relapsing 12.04 10.64 9 67523 901 63420589
Abdominal discomfort 12.03 10.64 255 67277 320630 63100860
Xanthelasma 11.90 10.64 4 67528 68 63421422
Eye infection 11.82 10.64 34 67498 12111 63409379
Nephrogenic systemic fibrosis 11.81 10.64 19 67513 4537 63416953
Abortion spontaneous 11.80 10.64 20 67512 47175 63374315
Paresis 11.78 10.64 14 67518 2516 63418974
Non-high-density lipoprotein cholesterol increased 11.64 10.64 5 67527 170 63421320
Stent placement 11.62 10.64 17 67515 3738 63417752
Musculoskeletal stiffness 11.58 10.64 133 67399 184485 63237005
Seizure 11.57 10.64 88 67444 132546 63288944
Eczema 11.46 10.64 66 67466 32225 63389265
Hospitalisation 11.45 10.64 49 67483 85032 63336458
Neutrophil count decreased 11.45 10.64 27 67505 56379 63365111
Increased appetite 11.43 10.64 29 67503 9601 63411889
Electrocardiogram Q wave abnormal 11.43 10.64 5 67527 178 63421312
Hypotrichosis 11.40 10.64 5 67527 179 63421311
Discontinued product administered 11.39 10.64 4 67528 78 63421412
Cardiac valve disease 11.39 10.64 18 67514 4234 63417256
International normalised ratio increased 11.10 10.64 86 67446 46339 63375151
Skin lesion 11.04 10.64 63 67469 30658 63390832
Hypertension 10.92 10.64 381 67151 278922 63142568
Drug abuse 10.88 10.64 40 67492 72478 63349012
Multiple sclerosis relapse 10.83 10.64 22 67510 48456 63373034
Adjustment disorder 10.73 10.64 15 67517 3163 63418327
Lower gastrointestinal haemorrhage 10.68 10.64 25 67507 7865 63413625

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
Myalgia 1111.98 11.13 1013 58944 83097 34813877
Rhabdomyolysis 543.47 11.13 626 59331 67537 34829437
Blood creatine phosphokinase increased 540.74 11.13 514 59443 44343 34852631
Myopathy 310.58 11.13 212 59745 11342 34885632
Low density lipoprotein increased 224.24 11.13 122 59835 4314 34892660
Myocardial infarction 156.64 11.13 510 59447 120575 34776399
Angina pectoris 146.72 11.13 222 59735 31141 34865833
Coronary artery disease 139.29 11.13 276 59681 48029 34848945
Off label use 125.12 11.13 341 59616 419183 34477791
Muscular weakness 117.61 11.13 332 59625 72565 34824409
Death 110.95 11.13 334 59623 397715 34499259
Toxicity to various agents 106.54 11.13 112 59845 200250 34696724
Low density lipoprotein decreased 101.13 11.13 46 59911 1097 34895877
Muscle spasms 92.46 11.13 311 59646 74690 34822284
High density lipoprotein decreased 88.71 11.13 61 59896 3299 34893675
Neutropenia 77.42 11.13 93 59864 156685 34740289
Drug abuse 73.70 11.13 39 59918 99057 34797917
Febrile neutropenia 72.10 11.13 77 59880 136772 34760202
Dizziness 69.41 11.13 624 59333 217897 34679077
Blood cholesterol increased 67.32 11.13 124 59833 20419 34876555
Immune-mediated myositis 65.09 11.13 42 59915 2041 34894933
Myositis 63.00 11.13 90 59867 11980 34884994
Blood triglycerides increased 61.66 11.13 97 59860 14062 34882912
Pancreatitis 61.56 11.13 176 59781 38715 34858259
Angina unstable 60.99 11.13 87 59870 11566 34885408
Hepatic enzyme increased 58.16 11.13 173 59784 38907 34858067
Venous pressure jugular increased 57.79 11.13 28 59929 773 34896201
Completed suicide 54.22 11.13 53 59904 98115 34798859
Drug interaction 54.22 11.13 609 59348 225337 34671637
Low density lipoprotein abnormal 50.56 11.13 20 59937 333 34896641
Foetal exposure during pregnancy 50.21 11.13 4 59953 38097 34858877
Muscle rupture 49.81 11.13 37 59920 2261 34894713
Asthenia 49.64 11.13 640 59317 244611 34652363
Dyspnoea exertional 46.85 11.13 172 59785 43107 34853867
Liver function test abnormal 46.65 11.13 138 59819 30936 34866038
Product use in unapproved indication 45.02 11.13 83 59874 117416 34779558
Coronary artery occlusion 44.85 11.13 73 59884 10889 34886085
Malignant neoplasm progression 44.73 11.13 51 59906 87995 34808979
Suicide attempt 44.30 11.13 7 59950 39109 34857865
Chest pain 43.80 11.13 369 59588 126393 34770581
Pancreatitis acute 43.22 11.13 126 59831 28015 34868959
Sepsis 43.20 11.13 144 59813 166417 34730557
Pneumonia 42.33 11.13 408 59549 362219 34534755
Chromaturia 41.85 11.13 83 59874 14437 34882537
Type V hyperlipidaemia 40.32 11.13 22 59935 782 34896192
Blood cholesterol decreased 39.67 11.13 24 59933 1040 34895934
Restrictive pulmonary disease 39.41 11.13 25 59932 1179 34895795
Erectile dysfunction 38.25 11.13 99 59858 20538 34876436
Amyotrophic lateral sclerosis 38.05 11.13 23 59934 995 34895979
Autoimmune hepatitis 37.97 11.13 42 59915 4318 34892656
Intentional overdose 37.46 11.13 14 59943 43660 34853314
Oedema peripheral 37.35 11.13 341 59616 119471 34777503
Inspiratory capacity abnormal 35.87 11.13 12 59945 120 34896854
Disease progression 34.97 11.13 84 59873 107993 34788981
Hyperuricaemia 34.88 11.13 55 59902 7988 34888986
Crush syndrome 33.80 11.13 10 59947 64 34896910
Muscle discomfort 32.97 11.13 11 59946 109 34896865
Septic shock 32.93 11.13 45 59912 71789 34825185
Radiation inflammation 32.68 11.13 20 59937 885 34896089
Left atrial dilatation 32.19 11.13 27 59930 1969 34895005
Acute myocardial infarction 32.08 11.13 179 59778 53540 34843434
Erythromelalgia 31.80 11.13 9 59948 48 34896926
Arteriosclerosis 31.63 11.13 66 59891 11902 34885072
Alanine aminotransferase increased 31.56 11.13 242 59715 80573 34816401
Pancytopenia 31.54 11.13 73 59884 95084 34801890
Cardiac failure congestive 31.22 11.13 247 59710 83023 34813951
Pain in extremity 31.18 11.13 343 59614 126170 34770804
Aspartate aminotransferase increased 31.10 11.13 211 59746 67572 34829402
Treatment failure 31.01 11.13 21 59936 46676 34850298
Ischaemic cardiomyopathy 30.96 11.13 46 59911 6343 34890631
Pyrexia 30.76 11.13 395 59562 332618 34564356
Drug ineffective for unapproved indication 29.87 11.13 3 59954 23712 34873262
Pulmonary pain 29.46 11.13 21 59936 1203 34895771
Glycogen storage disease type V 29.38 11.13 8 59949 36 34896938
Acute kidney injury 29.07 11.13 706 59251 304282 34592692
Hospitalisation 28.85 11.13 33 59924 56869 34840105
Diaphragmatic disorder 28.69 11.13 21 59936 1254 34895720
Left ventricular dysfunction 28.59 11.13 57 59900 9950 34887024
Muscle atrophy 28.53 11.13 48 59909 7356 34889618
Drug dependence 28.19 11.13 4 59953 24213 34872761
Hypovolaemia 28.09 11.13 54 59903 9180 34887794
Myasthenic syndrome 27.94 11.13 15 59942 516 34896458
Vascular stent stenosis 27.83 11.13 20 59937 1161 34895813
Exercise lack of 27.82 11.13 10 59947 126 34896848
Myocardial ischaemia 27.75 11.13 79 59878 17329 34879645
Infection 27.59 11.13 73 59884 90842 34806132
Intentional product use issue 26.89 11.13 38 59919 59778 34837196
Hypercholesterolaemia 26.36 11.13 51 59906 8711 34888263
Multiple organ dysfunction syndrome 25.97 11.13 58 59899 76508 34820466
Muscle disorder 25.90 11.13 27 59930 2594 34894380
Dissociation 25.86 11.13 22 59935 1636 34895338
Allergy to animal 25.66 11.13 13 59944 396 34896578
Coronary artery stenosis 25.37 11.13 53 59904 9563 34887411
Miller Fisher syndrome 25.06 11.13 9 59948 113 34896861
Haematocrit increased 25.00 11.13 24 59933 2089 34894885
Phaeochromocytoma malignant 24.66 11.13 8 59949 72 34896902
Prohormone brain natriuretic peptide increased 24.37 11.13 8 59949 75 34896899
Bone marrow failure 24.06 11.13 10 59947 29243 34867731
White blood cell count decreased 23.71 11.13 84 59873 95361 34801613
Dyspnoea at rest 23.69 11.13 31 59926 3797 34893177
Mucosal inflammation 23.53 11.13 19 59938 38603 34858371
Leukopenia 23.53 11.13 45 59912 62811 34834163
Exercise tolerance decreased 23.17 11.13 36 59921 5162 34891812
Cytomegalovirus infection 23.05 11.13 8 59949 26127 34870847
Ascites 22.55 11.13 28 59929 46543 34850431
Food aversion 22.24 11.13 12 59945 417 34896557
Cardio-respiratory arrest 22.09 11.13 38 59919 55235 34841739
Hyperthyroidism 22.01 11.13 53 59904 10513 34886461
Dyspnoea 22.01 11.13 821 59136 375961 34521013
Respiratory failure 21.11 11.13 105 59852 108467 34788507
Stent placement 21.02 11.13 34 59923 5044 34891930
C-reactive protein increased 20.89 11.13 38 59919 54060 34842914
Muscle necrosis 20.87 11.13 15 59942 871 34896103
Neuroleptic malignant syndrome 20.78 11.13 3 59954 17931 34879043
Overdose 20.76 11.13 83 59874 90976 34805998
Neutrophil count decreased 20.54 11.13 35 59922 51069 34845905
Product use issue 20.54 11.13 49 59908 63167 34833807
Toxic epidermal necrolysis 20.20 11.13 6 59951 21640 34875334
Heart valve stenosis 20.17 11.13 7 59950 79 34896895
Sclerodactylia 19.69 11.13 6 59951 43 34896931
Self esteem decreased 19.69 11.13 12 59945 527 34896447
Cardiac disorder 19.62 11.13 134 59823 42992 34853982
Troponin increased 19.44 11.13 53 59904 11336 34885638
Necrotising myositis 19.43 11.13 13 59944 672 34896302
Mucosal dryness 19.42 11.13 17 59940 1314 34895660
Atrial fibrillation 19.31 11.13 306 59651 122087 34774887
Sedation 19.28 11.13 6 59951 21000 34875974
Haemoglobin increased 18.65 11.13 26 59931 3383 34893591
Total cholesterol/HDL ratio increased 18.61 11.13 8 59949 166 34896808
Candida infection 18.28 11.13 4 59953 17711 34879263
Tendon injury 18.01 11.13 14 59943 916 34896058
Platelet count decreased 17.85 11.13 126 59831 119591 34777383
Arthralgia 17.80 11.13 399 59558 169642 34727332
ECG signs of myocardial ischaemia 17.65 11.13 8 59949 189 34896785
Aldolase increased 17.42 11.13 6 59951 66 34896908
Laryngeal discomfort 17.13 11.13 8 59949 203 34896771
Renal impairment 17.13 11.13 242 59715 94271 34802703
Myelosuppression 16.81 11.13 6 59951 19259 34877715
Suspected suicide attempt 16.80 11.13 7 59950 134 34896840
Faeces pale 16.72 11.13 16 59941 1387 34895587
Acute coronary syndrome 16.51 11.13 56 59901 13489 34883485
Dyslipidaemia 16.07 11.13 38 59919 7450 34889524
Heliotrope rash 15.96 11.13 4 59953 12 34896962
Orthostatic hypotension 15.88 11.13 87 59870 25832 34871142
Influenza like illness 15.77 11.13 91 59866 27543 34869431
Electrocardiogram abnormal 15.75 11.13 43 59914 9204 34887770
Haemorrhagic transformation stroke 15.61 11.13 16 59941 1507 34895467
Arteriosclerosis coronary artery 15.56 11.13 52 59905 12433 34884541
Back pain 15.43 11.13 294 59663 121495 34775479
Transaminases abnormal 15.31 11.13 8 59949 260 34896714
Agitation 15.28 11.13 49 59908 57350 34839624
Lymphocyte count decreased 15.25 11.13 10 59947 22612 34874362
Neurotoxicity 15.06 11.13 6 59951 18004 34878970
Neck pain 14.81 11.13 84 59873 25265 34871709
Blood creatine phosphokinase 14.59 11.13 6 59951 111 34896863
Microalbuminuria 14.54 11.13 11 59946 691 34896283
Respiratory arrest 14.50 11.13 16 59941 28027 34868947
Aggression 14.48 11.13 28 59929 38936 34858038
Injury 14.44 11.13 72 59885 20615 34876359
Coma 14.37 11.13 36 59921 45642 34851332
Dyspepsia 14.33 11.13 110 59847 36622 34860352
Respiratory depression 14.28 11.13 5 59952 16240 34880734
Lipoprotein (a) increased 14.20 11.13 5 59952 59 34896915
Ventricular tachycardia 14.19 11.13 86 59871 26493 34870481
Muscle injury 14.16 11.13 15 59942 1468 34895506
Stomatitis 13.77 11.13 33 59924 42481 34854493
Thrombocytopenia 13.76 11.13 187 59770 156060 34740914
Psychotic disorder 13.72 11.13 13 59944 24439 34872535
Fatigue 13.62 11.13 771 59186 369882 34527092
Pancreatitis necrotising 13.57 11.13 20 59937 2738 34894236
Flatulence 13.56 11.13 72 59885 21126 34875848
Weight decreased 13.54 11.13 397 59560 175904 34721070
Cardiovascular disorder 13.54 11.13 43 59914 10013 34886961
Syncope 13.43 11.13 226 59731 91225 34805749
Tendon rupture 13.36 11.13 34 59923 6978 34889996
Pseudoaldosteronism 13.30 11.13 5 59952 72 34896902
Vertigo 13.23 11.13 82 59875 25454 34871520
Serotonin syndrome 13.18 11.13 9 59948 19924 34877050
Paraesthesia 13.14 11.13 168 59789 64004 34832970
Pulmonary embolism 13.11 11.13 95 59862 89651 34807323
Ureteric cancer recurrent 12.97 11.13 4 59953 30 34896944
Systemic infection 12.91 11.13 28 59929 5184 34891790
Coronary artery bypass 12.91 11.13 27 59930 4875 34892099
Aortic bruit 12.90 11.13 7 59950 246 34896728
Pericardial haemorrhage 12.88 11.13 21 59936 3137 34893837
Aortic embolus 12.82 11.13 3 59954 6 34896968
Delusion 12.74 11.13 3 59954 12632 34884342
Hyperlipidaemia 12.69 11.13 54 59903 14475 34882499
Polymyositis 12.66 11.13 14 59943 1439 34895535
Impetigo 12.63 11.13 12 59945 1031 34895943
Muscle fatigue 12.56 11.13 14 59943 1451 34895523
Neoplasm progression 12.37 11.13 13 59944 23287 34873687
Pseudomonas infection 12.37 11.13 3 59954 12379 34884595
Infusion related reaction 12.31 11.13 48 59909 53009 34843965
Tumour lysis syndrome 12.25 11.13 7 59950 17052 34879922
Hypercapnic coma 12.21 11.13 6 59951 171 34896803
Influenza 12.13 11.13 44 59913 49622 34847352
Knee arthroplasty 12.07 11.13 34 59923 7410 34889564
Pancreatic neoplasm 12.06 11.13 11 59946 897 34896077
Iron binding capacity total increased 11.96 11.13 4 59953 40 34896934
Pancreatic carcinoma 11.92 11.13 38 59919 8863 34888111
Labelled drug-drug interaction medication error 11.89 11.13 54 59903 14885 34882089
Urogenital haemorrhage 11.85 11.13 10 59947 735 34896239
Hepatic failure 11.83 11.13 26 59931 34505 34862469
Drug withdrawal syndrome 11.78 11.13 10 59947 19824 34877150
Hepatitis cholestatic 11.64 11.13 35 59922 7912 34889062
Type IIa hyperlipidaemia 11.57 11.13 6 59951 192 34896782
Cutaneous lupus erythematosus 11.57 11.13 10 59947 760 34896214
Abulia 11.55 11.13 9 59948 591 34896383
Nephrosclerosis 11.53 11.13 11 59946 950 34896024
Potentiating drug interaction 11.50 11.13 26 59931 4951 34892023
Delirium 11.40 11.13 38 59919 43953 34853021
Therapeutic drug monitoring analysis incorrectly performed 11.21 11.13 7 59950 321 34896653

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Myalgia 1695.41 10.52 1608 101810 184033 79456937
Rhabdomyolysis 1047.50 10.52 949 102469 102182 79538788
Blood creatine phosphokinase increased 725.87 10.52 636 102782 65454 79575516
Myopathy 388.97 10.52 273 103145 20290 79620680
Low density lipoprotein increased 353.90 10.52 188 103230 8434 79632536
Coronary artery disease 255.50 10.52 367 103051 65107 79575863
Myocardial infarction 253.71 10.52 663 102755 183466 79457504
Angina pectoris 238.00 10.52 314 103104 51418 79589552
Muscular weakness 200.49 10.52 558 102860 160171 79480799
Off label use 198.19 10.52 566 102852 906649 78734321
Muscle spasms 196.10 10.52 584 102834 174146 79466824
Toxicity to various agents 171.87 10.52 176 103242 421364 79219606
Contraindicated product administered 124.86 10.52 26 103392 157512 79483458
Maternal exposure during pregnancy 113.58 10.52 20 103398 136518 79504452
Immune-mediated myositis 113.14 10.52 65 103353 3402 79637568
Synovitis 109.39 10.52 30 103388 150704 79490266
Drug interaction 105.60 10.52 908 102510 414275 79226695
Pancreatitis acute 104.07 10.52 211 103207 49393 79591577
Low density lipoprotein decreased 103.87 10.52 44 103374 1177 79639793
Completed suicide 100.74 10.52 102 103316 245665 79395305
Neutropenia 100.14 10.52 136 103282 287574 79353396
Pericarditis 99.22 10.52 10 103408 104226 79536744
Restrictive pulmonary disease 96.49 10.52 53 103365 2542 79638428
Liver function test abnormal 94.69 10.52 238 103180 64237 79576733
Acute kidney injury 93.55 10.52 1057 102361 518347 79122623
High density lipoprotein decreased 93.16 10.52 64 103354 4591 79636379
Dyslipidaemia 93.09 10.52 94 103324 11539 79629431
Death 90.22 10.52 403 103015 566111 79074859
Coronary artery occlusion 89.74 10.52 105 103313 15210 79625760
Drug ineffective 88 10.52 938 102480 1079975 78560995
Asthenia 87.53 10.52 1031 102387 510658 79130312
Infection 85.37 10.52 113 103305 241599 79399371
Dizziness 85.36 10.52 1050 102368 525391 79115579
Febrile neutropenia 84.68 10.52 105 103313 230894 79410076
Product use issue 83.81 10.52 89 103329 209733 79431237
Angina unstable 83.31 10.52 105 103313 16422 79624548
Therapeutic product effect decreased 83.29 10.52 55 103363 163808 79477162
Infusion related reaction 82.99 10.52 106 103312 230131 79410839
Pemphigus 81.92 10.52 15 103403 99567 79541403
Acute myocardial infarction 80.24 10.52 251 103167 76785 79564185
Myositis 79.99 10.52 111 103307 19057 79621913
Blood triglycerides increased 76.32 10.52 114 103304 20926 79620044
Muscle discomfort 76.20 10.52 24 103394 265 79640705
Flatulence 74.94 10.52 169 103249 42555 79598415
Pulmonary pain 74.53 10.52 55 103363 4418 79636552
Treatment failure 74.22 10.52 67 103351 170419 79470551
Vascular stent stenosis 73.31 10.52 37 103381 1490 79639480
Aspartate aminotransferase increased 71.29 10.52 362 103056 138279 79502691
Systemic lupus erythematosus 71.15 10.52 34 103384 121115 79519855
Hyper IgE syndrome 70.84 10.52 27 103391 544 79640426
Muscle rupture 69.34 10.52 49 103369 3678 79637292
Alanine aminotransferase increased 68.46 10.52 402 103016 162168 79478802
Cardiac failure congestive 65.13 10.52 360 103058 142042 79498928
Pain in extremity 63.78 10.52 738 102680 363800 79277170
Intentional product use issue 62.45 10.52 63 103355 152049 79488921
Crush syndrome 62.11 10.52 19 103399 189 79640781
Intentional overdose 61.82 10.52 30 103388 105930 79535040
Arterial occlusive disease 61.65 10.52 65 103353 8391 79632579
Chest pain 60.80 10.52 596 102822 281708 79359262
Drug abuse 59.55 10.52 74 103344 162617 79478353
Product use in unapproved indication 55.96 10.52 154 103264 250205 79390765
Glossodynia 54.82 10.52 33 103385 103304 79537666
Folliculitis 53.52 10.52 5 103413 55375 79585595
Chromaturia 52.20 10.52 108 103310 25638 79615332
Polymyositis 52.09 10.52 38 103380 2998 79637972
Pancreatitis 51.89 10.52 201 103217 68374 79572596
Coronary artery stenosis 51.65 10.52 72 103346 12412 79628558
Venous pressure jugular increased 51.57 10.52 28 103390 1312 79639658
Wound 51.34 10.52 45 103373 116134 79524836
Drug ineffective for unapproved indication 51.23 10.52 4 103414 51234 79589736
Low density lipoprotein abnormal 50.89 10.52 20 103398 439 79640531
Suicide attempt 50.68 10.52 22 103396 82910 79558060
Duodenal ulcer perforation 50.28 10.52 12 103406 66199 79574771
Exposure during pregnancy 49.96 10.52 35 103383 101097 79539873
Ischaemic cardiomyopathy 48.86 10.52 55 103363 7640 79633330
Disease progression 48.61 10.52 104 103314 184258 79456712
Acute coronary syndrome 46.84 10.52 92 103326 21041 79619929
Helicobacter infection 46.72 10.52 16 103402 69688 79571282
Dyspnoea exertional 46.61 10.52 230 103188 86843 79554127
Swelling 46.43 10.52 136 103282 216575 79424395
Body tinea 45.62 10.52 29 103389 1825 79639145
Erectile dysfunction 45.58 10.52 74 103344 14590 79626380
Stomatitis 45.55 10.52 75 103343 146682 79494288
Sleep disorder due to general medical condition, insomnia type 44.69 10.52 3 103415 43553 79597417
Sedation 44.48 10.52 7 103411 51888 79589082
Autoimmune hepatitis 44.40 10.52 65 103353 11718 79629252
Amyotrophic lateral sclerosis 43.69 10.52 28 103390 1787 79639183
Sepsis 43.17 10.52 191 103227 269237 79371733
Drug resistance 43.05 10.52 3 103415 42210 79598760
Carotid arteriosclerosis 42.78 10.52 32 103386 2624 79638346
Blood cholesterol decreased 42.49 10.52 27 103391 1698 79639272
Joint swelling 41.93 10.52 212 103206 288434 79352536
Pyrexia 40.83 10.52 627 102791 678082 78962888
Type V hyperlipidaemia 40.71 10.52 22 103396 1021 79639949
Inspiratory capacity abnormal 39.91 10.52 12 103406 112 79640858
Myopathy toxic 39.65 10.52 22 103396 1076 79639894
Palpitations 39.23 10.52 290 103128 126320 79514650
Cerebrovascular accident 39.02 10.52 339 103079 154953 79486017
Drug dependence 38.56 10.52 4 103414 40765 79600205
Alopecia 38.29 10.52 162 103256 231193 79409777
Malignant neoplasm progression 38.15 10.52 74 103344 135916 79505054
Radiation inflammation 37.89 10.52 20 103398 885 79640085
Necrotising myositis 36.71 10.52 22 103396 1246 79639724
Lipoprotein (a) increased 36.30 10.52 10 103408 66 79640904
Hyperuricaemia 35.94 10.52 59 103359 11740 79629230
Pancytopenia 34.78 10.52 105 103313 165640 79475330
Oedema peripheral 34.41 10.52 488 102930 251800 79389170
Arteriosclerosis 34.10 10.52 74 103344 18153 79622817
Muscle atrophy 33.99 10.52 56 103362 11176 79629794
ECG signs of myocardial ischaemia 33.86 10.52 14 103404 352 79640618
Inhibitory drug interaction 33.84 10.52 35 103383 4418 79636552
Bone marrow failure 33.79 10.52 12 103406 51095 79589875
Amyloid arthropathy 33.67 10.52 16 103402 564 79640406
Infection susceptibility increased 33.37 10.52 32 103386 3689 79637281
Blood cholesterol increased 33.28 10.52 204 103214 83516 79557454
Gangrene 33.13 10.52 49 103369 8915 79632055
Myocardial ischaemia 32.15 10.52 89 103329 25430 79615540
Fibromyalgia 32.13 10.52 22 103396 64318 79576652
Hyperlipidaemia 31.89 10.52 90 103328 26003 79614967
Muscle necrosis 31.45 10.52 21 103397 1437 79639533
Chest discomfort 31.43 10.52 295 103123 137749 79503221
Blister 30.98 10.52 68 103350 119408 79521562
Rheumatoid arthritis 30.89 10.52 152 103266 208318 79432652
Total cholesterol/HDL ratio increased 30.63 10.52 12 103406 261 79640709
Renal impairment 30.52 10.52 326 103092 157457 79483513
Toxic epidermal necrolysis 30.28 10.52 10 103408 44571 79596399
Diaphragmatic disorder 30.24 10.52 22 103396 1728 79639242
Endocrine ophthalmopathy 30.23 10.52 16 103402 712 79640258
Left atrial dilatation 29.96 10.52 28 103390 3125 79637845
Back pain 29.77 10.52 557 102861 303623 79337347
Glucose tolerance impaired 29.60 10.52 44 103374 8040 79632930
Atrial fibrillation 29.52 10.52 389 103029 197497 79443473
Skin disorder 29.45 10.52 104 103314 33839 79607131
Troponin increased 29.23 10.52 72 103346 19183 79621787
C-reactive protein increased 29.08 10.52 79 103339 128948 79512022
Septic shock 28.57 10.52 74 103344 122727 79518243
Carotid artery stenosis 28.32 10.52 45 103373 8713 79632257
Cytomegalovirus infection 28.21 10.52 10 103408 42634 79598336
Polycystic ovaries 27.46 10.52 29 103389 3750 79637220
Phaeochromocytoma malignant 26.87 10.52 8 103410 72 79640898
Blood glucose increased 26.82 10.52 247 103171 114728 79526242
Purpura 26.51 10.52 70 103348 19457 79621513
Irritable bowel syndrome 26.43 10.52 25 103393 62216 79578754
Gastric disorder 26.13 10.52 107 103311 37326 79603644
Psoriatic arthropathy 25.97 10.52 38 103380 77961 79563009
Ascites 25.96 10.52 36 103382 75526 79565444
Depressed level of consciousness 25.90 10.52 54 103364 96598 79544372
Gastrooesophageal reflux disease 25.88 10.52 227 103191 104019 79536951
Hospitalisation 25.80 10.52 52 103366 94184 79546786
Myasthenic syndrome 25.39 10.52 15 103403 827 79640143
Carotid artery thrombosis 25.03 10.52 25 103393 3028 79637942
Mucosal inflammation 24.99 10.52 37 103381 75543 79565427
Vulvovaginal burning sensation 24.97 10.52 19 103399 1598 79639372
Weight decreased 24.97 10.52 620 102798 354578 79286392
Left ventricular dysfunction 24.87 10.52 68 103350 19293 79621677
Toxic shock syndrome 24.59 10.52 17 103401 1232 79639738
Sensorimotor disorder 24.56 10.52 15 103403 879 79640091
Exercise tolerance decreased 24.50 10.52 43 103375 9028 79631942
Lipids increased 24.42 10.52 19 103399 1652 79639318
Heart valve stenosis 24.20 10.52 9 103409 169 79640801
Somnolence 24.18 10.52 196 103222 238785 79402185
Neutrophil count decreased 23.93 10.52 54 103364 93905 79547065
Muscle injury 23.73 10.52 17 103401 48544 79592426
Therapy cessation 23.61 10.52 104 103314 37458 79603512
Arteriosclerosis coronary artery 23.31 10.52 63 103355 17753 79623217
Encephalopathy 23.27 10.52 32 103386 67365 79573605
Heliotrope rash 23.09 10.52 9 103409 193 79640777
Hypersensitivity 23.04 10.52 223 103195 262016 79378954
Nasal dryness 23.01 10.52 29 103389 4534 79636436
Coma acidotic 22.75 10.52 8 103410 127 79640843
Glycogen storage disease type V 22.71 10.52 6 103412 33 79640937
Neurotoxicity 22.61 10.52 7 103411 32511 79608459
Myoglobin blood increased 22.58 10.52 24 103394 3127 79637843
Intentional self-injury 22.50 10.52 7 103411 32412 79608558
Neurologic neglect syndrome 22.37 10.52 23 103395 2884 79638086
Language disorder 22.18 10.52 24 103394 3190 79637780
Obstructive pancreatitis 22.09 10.52 14 103404 876 79640094
Sinus congestion 21.80 10.52 66 103352 19830 79621140
Eyelid disorder 21.61 10.52 19 103399 1959 79639011
Blood creatine phosphokinase 21.38 10.52 8 103410 153 79640817
Syncope 21.29 10.52 339 103079 179110 79461860
International normalised ratio increased 21.29 10.52 185 103233 84536 79556434
Cytokine release syndrome 21.28 10.52 10 103408 35988 79604982
Glycosylated haemoglobin increased 21.20 10.52 64 103354 19196 79621774
Myelosuppression 21.18 10.52 13 103405 40283 79600687
Blood pressure increased 21.00 10.52 388 103030 210972 79429998
Haematocrit increased 20.92 10.52 26 103392 4008 79636962
Muscle disorder 20.81 10.52 31 103387 5676 79635294
Sleep apnoea syndrome 20.69 10.52 98 103320 36380 79604590
Hypovolaemia 20.63 10.52 60 103358 17631 79623339
Rhinalgia 20.55 10.52 20 103398 2347 79638623
Euglycaemic diabetic ketoacidosis 20.54 10.52 34 103384 6810 79634160
Platelet count decreased 20.45 10.52 158 103260 194506 79446464
Miller Fisher syndrome 20.44 10.52 9 103409 265 79640705
Stent placement 20.39 10.52 33 103385 6487 79634483
Nasal ulcer 20.33 10.52 19 103399 2121 79638849
Faeces pale 20.31 10.52 22 103396 2928 79638042
Nasal discomfort 20.30 10.52 30 103388 5453 79635517
Gait disturbance 20.29 10.52 380 103038 207126 79433844
Nasopharyngitis 20.20 10.52 221 103197 253660 79387310
Pregnancy 20.12 10.52 5 103413 26846 79614124
Transient ischaemic attack 20.06 10.52 127 103291 52568 79588402
Influenza like illness 19.84 10.52 160 103258 71547 79569423
Copper metabolism disorder 19.83 10.52 4 103414 4 79640966
Vascular purpura 19.43 10.52 22 103396 3076 79637894
Xanthoma 19.43 10.52 8 103410 199 79640771
Erythromelalgia 19.31 10.52 8 103410 202 79640768
Cerebrovascular arteriovenous malformation 19.31 10.52 7 103411 122 79640848
Labelled drug-drug interaction medication error 19.27 10.52 79 103339 27571 79613399
Cardio-respiratory arrest 19.18 10.52 74 103344 108436 79532534
Electrocardiogram QT prolonged 19.14 10.52 57 103361 90329 79550641
Device expulsion 19.03 10.52 5 103413 25856 79615114
Vulvovaginal pruritus 18.77 10.52 20 103398 2613 79638357
Systemic infection 18.71 10.52 40 103378 9712 79631258
Biliary fibrosis 18.56 10.52 4 103414 7 79640963
Neutropenic sepsis 18.50 10.52 6 103412 27058 79613912
Arthropathy 18.49 10.52 144 103274 176967 79464003
Aortic stenosis 18.30 10.52 34 103384 7461 79633509
Exercise lack of 18.04 10.52 10 103408 488 79640482
Cataract 17.95 10.52 140 103278 61980 79578990
Electrocardiogram abnormal 17.85 10.52 55 103363 16682 79624288
Ligament rupture 17.80 10.52 22 103396 3372 79637598
Total cholesterol/HDL ratio decreased 17.77 10.52 5 103413 36 79640934
Peripheral swelling 17.57 10.52 245 103173 269372 79371598
Hepatic function abnormal 17.52 10.52 158 103260 72949 79568021
Diabetic neuropathy 17.49 10.52 30 103388 6186 79634784
White blood cell count decreased 17.44 10.52 158 103260 188130 79452840
Respiratory depression 17.41 10.52 7 103411 27623 79613347
Neoplasm progression 17.38 10.52 25 103393 51657 79589313
Hepatitis cholestatic 17.14 10.52 48 103370 13804 79627166
Prohormone brain natriuretic peptide increased 17.00 10.52 8 103410 276 79640694
Tendon injury 16.96 10.52 17 103401 2068 79638902
Intervertebral disc degeneration 16.95 10.52 52 103366 15733 79625237
Microscopic polyangiitis 16.93 10.52 9 103409 404 79640566
Aortic bruit 16.92 10.52 8 103410 279 79640691
Hypercholesterolaemia 16.90 10.52 67 103351 23028 79617942
Overdose 16.88 10.52 155 103263 184051 79456919
Anembryonic gestation 16.87 10.52 9 103409 407 79640563
Pneumonia 16.79 10.52 693 102725 659553 78981417
Thrombotic microangiopathy 16.66 10.52 3 103415 20166 79620804
Autoimmune myositis 16.50 10.52 8 103410 295 79640675
Haemoglobin increased 16.48 10.52 29 103389 6103 79634867
Mobility decreased 16.45 10.52 92 103326 122083 79518887
Haematochezia 16.43 10.52 180 103238 87465 79553505
Helicobacter gastritis 16.40 10.52 18 103400 2431 79638539
Dissociation 16.35 10.52 23 103395 3998 79636972
Status epilepticus 16.35 10.52 6 103412 25035 79615935
Dyspepsia 16.34 10.52 214 103204 108473 79532497
Spontaneous haematoma 16.22 10.52 14 103404 1408 79639562
Multiple sclerosis relapse 16.16 10.52 22 103396 46511 79594459
Clostridium difficile infection 16.05 10.52 19 103399 42666 79598304
Peripheral arterial occlusive disease 15.99 10.52 34 103384 8224 79632746
Hyperthyroidism 15.91 10.52 64 103354 22145 79618825
Blood creatinine increased 15.87 10.52 286 103132 154771 79486199
Hyperkalaemia 15.86 10.52 222 103196 114176 79526794
Dermatitis atopic 15.68 10.52 38 103380 10018 79630952
Muscle fatigue 15.62 10.52 21 103397 3498 79637472
Leukopenia 15.55 10.52 88 103330 116425 79524545
Pseudomonas infection 15.46 10.52 4 103414 20899 79620071
Renovascular hypertension 15.42 10.52 5 103413 61 79640909
Delirium 15.42 10.52 57 103361 84570 79556400
Renal failure 15.37 10.52 355 103063 200613 79440357
Impaired healing 15.35 10.52 60 103358 87595 79553375
Tumour lysis syndrome 15.19 10.52 6 103412 23933 79617037
Glomerular filtration rate decreased 15.14 10.52 64 103354 22638 79618332
Diabetes mellitus inadequate control 15.11 10.52 67 103351 24197 79616773
Oral herpes 15.03 10.52 73 103345 27381 79613589
Hypoparathyroidism 15.00 10.52 12 103406 1086 79639884
Myoglobinuria 14.98 10.52 12 103406 1088 79639882
Melaena 14.80 10.52 132 103286 60758 79580212
Transferrin decreased 14.58 10.52 8 103410 383 79640587
Paranasal sinus discomfort 14.55 10.52 23 103395 4433 79636537
Hepatic steatosis 14.39 10.52 91 103327 37647 79603323
Chronic kidney disease 14.37 10.52 140 103278 66014 79574956
Palmar erythema 14.25 10.52 15 103403 1932 79639038
Faeces discoloured 14.22 10.52 75 103343 29052 79611918
Cardiac failure chronic 14.19 10.52 39 103379 11096 79629874
Cognitive disorder 14.16 10.52 45 103373 69881 79571089
Hepatitis 14.16 10.52 122 103296 55605 79585365
Sensory loss 14.14 10.52 43 103375 12948 79628022
Allergy to animal 14.10 10.52 13 103405 1426 79639544
Dyspnoea at rest 14.07 10.52 30 103388 7272 79633698
Urogenital haemorrhage 14.04 10.52 11 103407 966 79640004
Pallor 14.01 10.52 112 103306 49950 79591020
Cardiac valve disease 13.96 10.52 26 103392 5715 79635255
Anuria 13.91 10.52 59 103359 20904 79620066
Chronic spontaneous urticaria 13.86 10.52 12 103406 1212 79639758
Biliary obstruction 13.73 10.52 23 103395 4651 79636319
Torsade de pointes 13.71 10.52 4 103414 19308 79621662
Agitation 13.47 10.52 75 103343 99640 79541330
Coma 13.44 10.52 76 103342 100573 79540397
Skin haemorrhage 13.37 10.52 40 103378 11941 79629029
Hypocholesterolaemia 13.31 10.52 6 103412 187 79640783
Dyspnoea 13.19 10.52 1286 102132 855739 78785231
Delusion 13.15 10.52 5 103413 20418 79620552
Respiratory arrest 13.14 10.52 35 103383 57515 79583455
Nasal cyst 13.06 10.52 4 103414 40 79640930
Lipase increased 13.06 10.52 49 103369 16417 79624553
Grip strength decreased 13.04 10.52 6 103412 21863 79619107
Neuroleptic malignant syndrome 13.01 10.52 10 103408 27549 79613421
Bacteraemia 13.00 10.52 14 103404 32810 79608160
Pancreatic carcinoma 13.00 10.52 43 103375 13534 79627436
Coronary artery thrombosis 12.98 10.52 18 103400 3088 79637882
Blood creatine phosphokinase MM increased 12.97 10.52 4 103414 41 79640929
Product prescribing error 12.95 10.52 101 103317 44712 79596258
Cystitis noninfective 12.93 10.52 12 103406 1328 79639642
Eczema 12.92 10.52 94 103324 40724 79600246
Myasthenia gravis 12.84 10.52 36 103382 10363 79630607
Suspected suicide attempt 12.83 10.52 7 103411 331 79640639
General physical condition 12.80 10.52 3 103415 9 79640961
Acquired epidermolysis bullosa 12.80 10.52 5 103413 108 79640862
Product substitution issue 12.66 10.52 56 103362 20200 79620770
Pulmonary embolism 12.64 10.52 152 103266 171502 79469468
Dystonia 12.57 10.52 6 103412 21393 79619577
Mucosal dryness 12.50 10.52 19 103399 3540 79637430
Peripheral artery occlusion 12.50 10.52 16 103402 2541 79638429
Diabetes mellitus 12.48 10.52 156 103262 78234 79562736
Cardiac murmur 12.47 10.52 47 103371 15777 79625193
Lymphadenopathy 12.45 10.52 32 103386 53215 79587755
Ventricular tachycardia 12.38 10.52 95 103323 41840 79599130
Potentiating drug interaction 12.36 10.52 32 103386 8787 79632183
Cerebellar syndrome 12.32 10.52 24 103394 5456 79635514
Dermatomyositis 12.25 10.52 19 103399 3604 79637366
Arterial stenosis 12.22 10.52 12 103406 1424 79639546
Cardiovascular disorder 12.17 10.52 51 103367 17974 79622996
Vertebral foraminal stenosis 12.16 10.52 11 103407 1178 79639792
Tendon rupture 12.15 10.52 39 103379 12087 79628883
Hyperparathyroidism secondary 12.00 10.52 16 103402 2644 79638326
Impaired work ability 11.99 10.52 54 103364 19627 79621343
Lower gastrointestinal haemorrhage 11.98 10.52 47 103371 16078 79624892
Multiple organ dysfunction syndrome 11.98 10.52 99 103319 120147 79520823
Pancreatic neoplasm 11.94 10.52 12 103406 1464 79639506
Vascular access site pain 11.94 10.52 5 103413 130 79640840
Haemorrhagic transformation stroke 11.85 10.52 16 103402 2676 79638294
Cardiac disorder 11.85 10.52 134 103284 65623 79575347
Aortic valve calcification 11.79 10.52 9 103409 761 79640209
Coronary artery bypass 11.79 10.52 25 103393 6037 79634933
Iron binding capacity total decreased 11.75 10.52 7 103411 392 79640578
Pericardial haemorrhage 11.74 10.52 21 103397 4474 79636496
Aldolase increased 11.74 10.52 6 103412 248 79640722
Pleural effusion 11.73 10.52 126 103292 145136 79495834
Lower respiratory tract infection 11.72 10.52 109 103309 129111 79511859
Gingival oedema 11.71 10.52 4 103414 58 79640912
Self esteem decreased 11.71 10.52 10 103408 992 79639978
Therapy non-responder 11.63 10.52 71 103347 92234 79548736
Dyskinesia oesophageal 11.58 10.52 4 103414 60 79640910
Photopsia 11.55 10.52 23 103395 5313 79635657
Haemophagocytic lymphohistiocytosis 11.54 10.52 7 103411 21830 79619140
Vaginal haemorrhage 11.52 10.52 7 103411 21810 79619160
Hemiplegia 11.47 10.52 44 103374 14895 79626075
Laryngeal discomfort 11.42 10.52 8 103410 592 79640378
Disseminated intravascular coagulation 11.41 10.52 18 103400 35824 79605146
Haematuria 11.39 10.52 138 103280 68698 79572272
Hypercapnic coma 11.36 10.52 7 103411 417 79640553
Steroid diabetes 11.32 10.52 18 103400 3488 79637482
Melanaemia 11.29 10.52 4 103414 65 79640905
Bronchomalacia 11.25 10.52 6 103412 271 79640699
Food aversion 11.19 10.52 10 103408 1053 79639917
Lipids abnormal 11.17 10.52 8 103410 613 79640357
Seizure 11.11 10.52 175 103243 188659 79452311
Abdominal pain upper 11.09 10.52 374 103044 223445 79417525
Hypophosphataemia 11.07 10.52 6 103412 19907 79621063
Discomfort 10.95 10.52 107 103311 125510 79515460
Sclerodactylia 10.94 10.52 5 103413 161 79640809
Bone density decreased 10.82 10.52 40 103378 13307 79627663
Impaired quality of life 10.74 10.52 42 103376 14344 79626626
Restless legs syndrome 10.69 10.52 53 103365 20039 79620931
Pseudoaldosteronism 10.66 10.52 5 103413 171 79640799
Lymphocyte count decreased 10.61 10.52 29 103389 47260 79593710
Fatigue 10.59 10.52 1368 102050 928359 78712611
Productive cough 10.59 10.52 69 103349 88262 79552708

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AX09 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Other lipid modifying agents
ATC C10BA02 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA05 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA06 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA10 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA11 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA12 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
FDA PE N0000008553 Decreased Cholesterol Absorption
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000175911 Dietary Cholesterol Absorption Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35679 antilipemic drugs
CHEBI has role CHEBI:35821 anticholesteremic drugs

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

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Hyperlipidemia indication 55822004 DOID:1168
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Sitosterolemia indication 238104009 DOID:0090019
Mixed hyperlipidemia indication 267434003
Alopecia areata off-label use 68225006 DOID:986
Alcoholism contraindication 7200002
Acute nephropathy contraindication 58574008
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Hemorrhagic cerebral infarction contraindication 230706003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Pregnancy, function contraindication 289908002
Surgical procedure contraindication 387713003
Breastfeeding (mother) contraindication 413712001
SLCO1B1 Gene Variant for OATP1B1 Transporter Affecting Hepatic Clearance contraindication
Myopathy related to SLCO1B1 Gene Variant contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.48 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 10118881 Dec. 23, 2023 USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 10941095 Dec. 23, 2023 USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 8497301 Dec. 23, 2023 USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 9000041 Dec. 23, 2023 USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 9624152 Dec. 23, 2023 USE OF NEXLIZET AS AN ADJUNCT TO DIET AND MAXIMALLY TOLERATED STATIN THERAPY FOR INHIBITING CHOLESTEROL SYNTHESIS TO LOWER LDL-C IN ADULTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
10MG ZETIA ORGANON N021445 Oct. 25, 2002 RX TABLET ORAL 7612058 Oct. 30, 2025 REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
10MG ZETIA ORGANON N021445 Oct. 25, 2002 RX TABLET ORAL 7612058 Oct. 30, 2025 TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A STATIN OR WITH FENOFIBRATE
10MG;EQ 10MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 10MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 20MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 40MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 10376470 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
10MG;EQ 5MG BASE ROSZET ALTHERA PHARMS N213072 March 23, 2021 DISCN TABLET ORAL 9763885 May 1, 2033 TREATMENT OF HYPERLIPIDEMIA
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL 10912751 March 14, 2036 A METHOD OF TREATING HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA OR ESTABLISHED ATHEROSCLEROTIC CARDIOVASCULAR DISEASE BY DECREASING THE LEVEL OF LDL-C USING A FIXED DOSE COMBINATION OF 180 MG BEMPEDOIC ACID AND 10 MG EZETIMIBE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL Feb. 26, 2023 NEW PRODUCT
180MG;10MG NEXLIZET ESPERION THERAPS INC N211617 Feb. 26, 2020 RX TABLET ORAL Feb. 21, 2025 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Niemann-Pick C1-like protein 1 Membrane other ANTAGONIST Kd 6.66 IUPHAR CHEMBL
Sodium/bile acid cotransporter Transporter Ki 4.60 CHEMBL
Niemann-Pick C1-like protein 1 Unclassified Ki 6.70 CHEMBL

External reference:

IDSource
4021366 VUID
N0000148785 NUI
D01966 KEGG_DRUG
4021366 VANDF
C1142985 UMLSCUI
CHEBI:49040 CHEBI
H56 PDB_CHEM_ID
CHEMBL1138 ChEMBL_ID
D000069438 MESH_DESCRIPTOR_UI
DB00973 DRUGBANK_ID
150311 PUBCHEM_CID
6816 IUPHAR_LIGAND_ID
8010 INN_ID
EOR26LQQ24 UNII
341248 RXNORM
17026 MMSL
229065 MMSL
45364 MMSL
d04824 MMSL
009817 NDDF
408041006 SNOMEDCT_US
409149001 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0591-3713 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0615-8300 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0615-8300 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0781-5690 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0904-6664 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0904-7103 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0904-7103 TABLET 10 mg ORAL ANDA 26 sections
Ezetimibe HUMAN PRESCRIPTION DRUG LABEL 1 0904-7103 TABLET 10 mg ORAL ANDA 26 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-778 TABLET 10 mg ORAL ANDA 28 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-779 TABLET 10 mg ORAL ANDA 28 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-780 TABLET 10 mg ORAL ANDA 28 sections
ezetimibe and simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 16714-781 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe Human Prescription Drug Label 1 16714-813 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe Human Prescription Drug Label 1 16714-813 TABLET 10 mg ORAL ANDA 28 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 16729-433 TABLET 10 mg ORAL ANDA 29 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 16729-433 TABLET 10 mg ORAL ANDA 29 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-325 TABLET 10 mg ORAL NDA 28 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-339 TABLET 10 mg ORAL NDA 28 sections
Zetia HUMAN PRESCRIPTION DRUG LABEL 1 21695-778 TABLET 10 mg ORAL NDA 29 sections
VYTORIN HUMAN PRESCRIPTION DRUG LABEL 2 21695-827 TABLET 10 mg ORAL NDA 28 sections
EZETIMIBE HUMAN PRESCRIPTION DRUG LABEL 1 31722-628 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 42291-078 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 42291-079 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 42291-080 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 42291-081 TABLET 10 mg ORAL ANDA 27 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-742 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-743 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-744 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 43598-745 TABLET 10 mg ORAL ANDA 28 sections
Ezetimibe and Simvastatin HUMAN PRESCRIPTION DRUG LABEL 2 45963-565 TABLET 10 mg ORAL ANDA 27 sections