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

Stem definitionDrug idCAS RN
clofibrate derivatives, peroxisome proliferator activated receptor-alpha(PPAR-alpha) agonists 1152 49562-28-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • fenofibrate
  • clorofibrate
  • fenobrate
  • lipofene
  • procetofen
  • procetofene
An antilipemic agent which reduces both CHOLESTEROL and TRIGLYCERIDES in the blood.
  • Molecular weight: 360.83
  • Formula: C20H21ClO4
  • CLOGP: 5.23
  • LIPINSKI: 1
  • HAC: 4
  • HDO: 0
  • TPSA: 52.60
  • ALOGS: -5.71
  • ROTB: 7
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.00 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.10 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 5.74 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
April 14, 2011 EMA LABORATOIRES SMB S.A.
Dec. 31, 1993 FDA ABBVIE

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 258.28 10.86 215 38841 43736 63406230
Pancreatitis acute 193.93 10.86 149 38907 27017 63422949
Acute kidney injury 176.87 10.86 454 38602 262961 63187005
Blood triglycerides increased 166.99 10.86 101 38955 12387 63437579
Pancreatitis 164.81 10.86 176 38880 48879 63401087
Myalgia 118.97 10.86 272 38784 146257 63303709
Contraindicated product administered 93.13 10.86 12 39044 217636 63232330
Pemphigus 92.58 10.86 5 39051 183721 63266245
Systemic lupus erythematosus 85.91 10.86 13 39043 208905 63241061
Hand deformity 84.75 10.86 3 39053 159454 63290512
Blood creatine phosphokinase increased 84.69 10.86 99 38957 30331 63419635
High density lipoprotein decreased 83.96 10.86 36 39020 2134 63447832
Glossodynia 81.20 10.86 8 39048 178868 63271098
Renal failure 81.04 10.86 205 38851 117447 63332519
International normalised ratio increased 79.50 10.86 119 38937 46306 63403660
Treatment failure 78.23 10.86 14 39042 199029 63250937
Drug interaction 68.65 10.86 301 38755 228830 63221136
Maternal exposure during pregnancy 68.30 10.86 25 39031 220037 63229929
Drug ineffective 67.15 10.86 374 38682 1044391 62405575
Hypertriglyceridaemia 67.06 10.86 44 39012 6215 63443751
Pericarditis 64.99 10.86 4 39052 131575 63318391
Wound 60.95 10.86 13 39043 163250 63286716
Hepatic function abnormal 60.46 10.86 93 38963 37049 63412917
Arthropathy 57.19 10.86 37 39019 234755 63215211
Therapeutic product effect decreased 56.56 10.86 24 39032 193163 63256803
Confabulation 54.57 10.86 16 39040 304 63449662
Rheumatoid arthritis 52.86 10.86 47 39009 253772 63196194
Infusion related reaction 51.69 10.86 45 39011 245476 63204490
Joint swelling 49.71 10.86 78 38978 327588 63122378
Blood glucose increased 48.60 10.86 137 38919 83619 63366347
Abdominal discomfort 47.16 10.86 78 38978 320807 63129159
Off label use 46.73 10.86 235 38821 674227 62775739
Glycosylated haemoglobin increased 46.12 10.86 47 39009 12351 63437615
Jaundice 45.87 10.86 72 38984 29179 63420787
Alopecia 45.15 10.86 87 38969 337449 63112517
Vulvovaginal burning sensation 44.43 10.86 23 39033 2086 63447880
Product use issue 43.36 10.86 43 39013 220477 63229489
Myocardial infarction 42.76 10.86 147 38909 99746 63350220
Coronary artery disease 41.77 10.86 73 38983 32304 63417662
Rhinalgia 41.23 10.86 20 39036 1579 63448387
Skin weeping 41.14 10.86 16 39040 737 63449229
Rectosigmoid cancer 40.98 10.86 11 39045 149 63449817
Vulvovaginal pruritus 40.21 10.86 25 39031 3218 63446748
Hepatorenal failure 38.82 10.86 15 39041 679 63449287
Myoglobin blood increased 37.52 10.86 18 39038 1387 63448579
Fall 36.41 10.86 385 38671 391949 63058017
Hepatic steatosis 35.99 10.86 64 38992 28705 63421261
Nephrosclerosis 35.95 10.86 16 39040 1038 63448928
Swelling 35.07 10.86 73 38983 275305 63174661
Psoriasis 34.65 10.86 125 38931 86832 63363134
Lichenoid keratosis 33.46 10.86 18 39038 1765 63448201
Hypertonic bladder 33.12 10.86 23 39033 3565 63446401
Hypersensitivity 32.13 10.86 84 38972 292601 63157365
Hyperglycaemia 32.03 10.86 76 38980 41791 63408175
Lichen nitidus 31.50 10.86 8 39048 86 63449880
Alkalosis hypochloraemic 31.36 10.86 9 39047 158 63449808
Pancreatitis necrotising 31.34 10.86 17 39039 1695 63448271
Cholestasis 31.22 10.86 61 38995 29373 63420593
Diabetes mellitus 31.11 10.86 90 38966 55720 63394246
Photosensitivity reaction 30.91 10.86 42 39014 14952 63435014
Hypoglycaemia 30.76 10.86 94 38962 59971 63389995
Discomfort 30.26 10.86 35 39021 167339 63282627
Lactic acidosis 29.83 10.86 70 38986 38217 63411749
Apolipoprotein A-I decreased 29.58 10.86 6 39050 20 63449946
Stomatitis 28.48 10.86 26 39030 138699 63311267
Orbital compartment syndrome 27.93 10.86 7 39049 71 63449895
Dyslipidaemia 27.45 10.86 28 39028 7365 63442601
Total cholesterol/HDL ratio abnormal 27.41 10.86 7 39049 77 63449889
Kidney fibrosis 27.19 10.86 16 39040 1865 63448101
Myotonia 27.04 10.86 8 39048 157 63449809
Dilatation ventricular 25.73 10.86 17 39039 2428 63447538
Myopathy 25.61 10.86 33 39023 11158 63438808
Injection site extravasation 24.99 10.86 29 39027 8812 63441154
Change of bowel habit 24.92 10.86 16 39040 2177 63447789
Paranasal sinus discomfort 24.84 10.86 21 39035 4355 63445611
Wheezing 24.74 10.86 14 39042 95581 63354385
Drug abuse 24.66 10.86 7 39049 72511 63377455
Cholelithiasis 24.64 10.86 71 38985 43854 63406112
Drug intolerance 24.59 10.86 102 38954 308559 63141407
Irritable bowel syndrome 24.49 10.86 10 39046 82402 63367564
Arterial spasm 24.02 10.86 6 39050 60 63449906
Multiple fractures 23.91 10.86 28 39028 8590 63441376
Impaired healing 23.82 10.86 17 39039 102525 63347441
Ocular icterus 23.80 10.86 19 39037 3637 63446329
Infection 23.47 10.86 68 38988 229105 63220861
Diabetes mellitus inadequate control 23.39 10.86 37 39019 15089 63434877
Mobility decreased 23.37 10.86 24 39032 121135 63328831
Narcotic bowel syndrome 23.26 10.86 7 39049 146 63449820
Congestive hepatopathy 22.89 10.86 17 39039 2925 63447041
Blood creatinine increased 22.27 10.86 110 38946 87734 63362232
Hepatic necrosis 21.96 10.86 22 39034 5665 63444301
Mucosal dryness 21.68 10.86 16 39040 2728 63447238
Pulmonary embolism 21.48 10.86 134 38922 116550 63333416
Increased appetite 21.42 10.86 28 39028 9602 63440364
Ill-defined disorder 21.12 10.86 12 39044 81743 63368223
Somnolence 20.78 10.86 184 38872 178501 63271465
Chronic cutaneous lupus erythematosus 20.50 10.86 8 39048 372 63449594
Aortic arteriosclerosis 20.34 10.86 22 39034 6187 63443779
Orthopnoea 20.19 10.86 22 39034 6239 63443727
Ophthalmoplegia 19.98 10.86 12 39044 1452 63448514
Normochromic normocytic anaemia 19.89 10.86 19 39037 4617 63445349
Hepatic fibrosis 19.65 10.86 17 39039 3635 63446331
Grandiosity 18.64 10.86 7 39049 293 63449673
Lower respiratory tract infection 18.63 10.86 33 39023 132274 63317692
Mitral valve disease 18.56 10.86 14 39042 2466 63447500
Product residue present 18.40 10.86 17 39039 3962 63446004
Exposure during pregnancy 18.33 10.86 43 39013 155504 63294462
Catheter site thrombosis 18.27 10.86 6 39050 168 63449798
Gastrointestinal disorder 18.24 10.86 33 39023 131206 63318760
Hyperlipidaemia 17.73 10.86 38 39018 19533 63430433
Nasopharyngitis 17.29 10.86 89 38967 254168 63195798
Proteinuria 17.14 10.86 37 39019 19108 63430858
Asthenia 17.10 10.86 331 38725 383273 63066693
Gastrointestinal haemorrhage 16.71 10.86 96 38960 81080 63368886
Vascular access site pain 16.67 10.86 5 39051 103 63449863
Renal impairment 16.59 10.86 102 38954 88253 63361713
Low density lipoprotein increased 16.56 10.86 20 39036 6337 63443629
Medulloblastoma 16.49 10.86 4 39052 35 63449931
Urinary tract infection 16.41 10.86 241 38815 264443 63185523
Hepatocellular injury 16.08 10.86 45 39011 27336 63422630
Musculoskeletal stiffness 15.97 10.86 59 38997 184559 63265407
Diabetic metabolic decompensation 15.87 10.86 11 39045 1699 63448267
Cholestatic liver injury 15.80 10.86 13 39043 2597 63447369
Chromaturia 15.77 10.86 33 39023 16684 63433282
Metastases to bone marrow 15.71 10.86 7 39049 455 63449511
Metabolic acidosis 15.64 10.86 62 38994 45007 63404959
Hyponatraemia 15.56 10.86 120 38936 111780 63338186
Hepatic enzyme increased 15.40 10.86 68 38988 202260 63247706
Intra-abdominal haematoma 15.34 10.86 11 39045 1794 63448172
Cardiac failure congestive 15.08 10.86 103 38953 92330 63357636
Essential hypertension 15.05 10.86 17 39039 5016 63444950
Product use in unapproved indication 14.99 10.86 58 38998 179022 63270944
Aphthous ulcer 14.92 10.86 29 39027 13909 63436057
Renal colic 14.87 10.86 10 39046 1471 63448495
Abnormal loss of weight 14.75 10.86 18 39038 5764 63444202
Xanthoma 14.65 10.86 4 39052 58 63449908
Hyperkalaemia 14.54 10.86 69 38987 54134 63395832
Peripheral swelling 14.43 10.86 100 38956 265842 63184124
Blister 14.42 10.86 37 39019 129777 63320189
Blood triglycerides abnormal 14.28 10.86 6 39050 338 63449628
Macule 14.19 10.86 11 39045 2017 63447949
Blood urea increased 14.18 10.86 42 39014 26337 63423629
Nicotinic acid deficiency 14.06 10.86 4 39052 68 63449898
Coronary artery occlusion 14.02 10.86 21 39035 8170 63441796
Blood triglycerides decreased 14.00 10.86 4 39052 69 63449897
Alanine aminotransferase 13.50 10.86 4 39052 79 63449887
Intentional product use issue 13.04 10.86 38 39018 127854 63322112
Polymyositis 13.04 10.86 10 39046 1806 63448160
Pain 12.93 10.86 352 38704 740276 62709690
Muscle contracture 12.92 10.86 9 39047 1402 63448564
Nasal dryness 12.90 10.86 15 39041 4566 63445400
Dermatomyositis 12.84 10.86 12 39044 2836 63447130
Dehydration 12.84 10.86 163 38893 173191 63276775
Livedo reticularis 12.44 10.86 11 39045 2421 63447545
Nasal discomfort 12.44 10.86 15 39041 4745 63445221
Hepatic failure 12.33 10.86 49 39007 35607 63414359
Renin decreased 12.28 10.86 4 39052 109 63449857
Depression 12.20 10.86 179 38877 196313 63253653
Haematoma muscle 12.20 10.86 8 39048 1129 63448837
Coagulation test abnormal 12.09 10.86 7 39049 791 63449175
Arthralgia 12.05 10.86 263 38793 569447 62880519
Paternal exposure during pregnancy 12.01 10.86 4 39052 117 63449849
Anhedonia 11.95 10.86 23 39033 10951 63439015
Blood glucose decreased 11.87 10.86 34 39022 20918 63429048
Lipids increased 11.82 10.86 8 39048 1189 63448777
Chronic sinusitis 11.70 10.86 25 39031 12818 63437148
Optic ischaemic neuropathy 11.67 10.86 8 39048 1214 63448752
Chronic kidney disease 11.61 10.86 57 38999 45341 63404625
Cholecystitis infective 11.41 10.86 9 39047 1693 63448273
Death 11.37 10.86 162 38894 374219 63075747
Upper-airway cough syndrome 11.31 10.86 23 39033 11395 63438571
Rash 11.27 10.86 261 38795 560610 62889356
Muscle spasms 11.21 10.86 146 38910 156004 63293962
Cholecystitis acute 11.14 10.86 19 39037 8241 63441725
Auditory disorder 11.13 10.86 6 39050 591 63449375
Shock haemorrhagic 11.10 10.86 21 39035 9874 63440092
Multiple injuries 10.98 10.86 9 39047 1789 63448177
Angina pectoris 10.94 10.86 42 39014 30036 63419930
Hip arthroplasty 10.93 10.86 8 39048 47638 63402328
Cerebrovascular accident 10.92 10.86 108 38948 107916 63342050
Pancoast's syndrome 10.89 10.86 3 39053 45 63449921

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
Pancreatitis acute 261.92 10.72 231 38770 27910 34890020
High density lipoprotein decreased 174.82 10.72 82 38919 3278 34914652
Pancreatitis 143.23 10.72 196 38805 38695 34879235
Blood triglycerides increased 129.21 10.72 115 38886 14044 34903886
Blood creatine phosphokinase increased 94.32 10.72 175 38826 44682 34873248
Myocardial infarction 94.10 10.72 323 38678 120762 34797168
Coronary artery disease 91.17 10.72 180 38821 48125 34869805
Myalgia 90.11 10.72 251 38750 83859 34834071
Hypertriglyceridaemia 83.87 10.72 72 38929 8376 34909554
Drug abuse 76.66 10.72 10 38991 99086 34818844
Rhabdomyolysis 65.80 10.72 196 38805 67967 34849963
Off label use 64.45 10.72 246 38755 419278 34498652
Toxicity to various agents 56.60 10.72 85 38916 200277 34717653
Pericardial disease 54.20 10.72 20 38981 430 34917500
Pulmonary valve disease 51.70 10.72 18 38983 325 34917605
Stenosis 47.45 10.72 26 38975 1447 34916483
Hepatic steatosis 41.56 10.72 74 38927 18288 34899642
Death 38.15 10.72 274 38727 397775 34520155
Drug-induced liver injury 37.95 10.72 93 38908 28739 34889191
Physical examination abnormal 37.73 10.72 14 38987 306 34917624
Acute kidney injury 34.61 10.72 504 38497 304484 34613446
Glycogen storage disease type V 32.80 10.72 8 38993 36 34917894
Pancreatitis necrotising 32.57 10.72 26 38975 2732 34915198
Blood glucose increased 32.48 10.72 154 38847 66564 34851366
Hyperlipidaemia 32.17 10.72 58 38943 14471 34903459
Cardiac discomfort 31.94 10.72 15 38986 601 34917329
Fibrillary glomerulonephritis 31.17 10.72 8 38993 46 34917884
Diabetic metabolic decompensation 30.67 10.72 21 38980 1745 34916185
Glycosylated haemoglobin increased 29.95 10.72 49 38952 11311 34906619
Acute myocardial infarction 29.88 10.72 129 38872 53590 34864340
Electrocardiogram Q wave abnormal 29.83 10.72 13 38988 436 34917494
Renal failure 29.77 10.72 248 38753 130309 34787621
Echocardiogram abnormal 29.45 10.72 17 38984 1046 34916884
Metabolic syndrome 29.02 10.72 20 38981 1679 34916251
Subacute kidney injury 29.00 10.72 5 38996 0 34917930
Libido disorder 28.76 10.72 11 38990 262 34917668
Psoriasis 27.88 10.72 101 38900 38711 34879219
Cholelithiasis 27.60 10.72 68 38933 21080 34896850
Myopathy 26.71 10.72 47 38954 11507 34906423
Pancreatic neoplasm 26.44 10.72 15 38986 893 34917037
Diabetes mellitus inadequate control 26.38 10.72 51 38950 13413 34904517
Hepatojugular reflux 26.21 10.72 13 38988 588 34917342
Ureteric injury 25.85 10.72 7 38994 51 34917879
Blood cholesterol increased 25.70 10.72 65 38936 20478 34897452
Blood triglycerides abnormal 25.58 10.72 10 38991 253 34917677
Ventricular arrhythmia 25.23 10.72 31 38970 5497 34912433
Mitral valve disease 24.94 10.72 17 38984 1402 34916528
Left ventricular dysfunction 24.82 10.72 42 38959 9965 34907965
Ischaemic cardiomyopathy 24.71 10.72 33 38968 6356 34911574
Liver disorder 24.67 10.72 87 38914 32910 34885020
Drug ineffective 23.74 10.72 363 38638 456388 34461542
Intentional overdose 22.91 10.72 10 38991 43664 34874266
Rales 22.58 10.72 40 38961 9843 34908087
Low density lipoprotein increased 22.09 10.72 26 38975 4410 34913520
Ectopic gastric mucosa 22.08 10.72 5 38996 15 34917915
Chest pain 21.93 10.72 227 38774 126535 34791395
Occult blood 21.73 10.72 13 38988 855 34917075
Euglycaemic diabetic ketoacidosis 21.45 10.72 22 38979 3200 34914730
Carotid artery stenosis 21.08 10.72 27 38974 4992 34912938
Gamma-glutamyltransferase increased 20.94 10.72 76 38925 29155 34888775
Blood creatinine increased 20.88 10.72 179 38822 94797 34823133
Tricuspid valve incompetence 20.39 10.72 38 38963 9722 34908208
Type 2 diabetes mellitus 20.34 10.72 51 38950 15981 34901949
Diabetic neuropathy 19.91 10.72 24 38977 4173 34913757
Helicobacter gastritis 19.83 10.72 14 38987 1222 34916708
Haemorrhagic fever 19.75 10.72 5 38996 27 34917903
Systolic dysfunction 18.96 10.72 19 38982 2689 34915241
Anticoagulation drug level above therapeutic 18.93 10.72 17 38984 2099 34915831
Meningitis streptococcal 18.52 10.72 5 38996 36 34917894
Product use in unapproved indication 18.51 10.72 68 38933 117431 34800499
Treatment failure 18.44 10.72 15 38986 46682 34871248
Mitral valve incompetence 18.40 10.72 47 38954 14896 34903034
Asthenia 18.24 10.72 379 38622 244872 34673058
Hepatic enzyme increased 18.13 10.72 89 38912 38991 34878939
Diastolic dysfunction 17.98 10.72 28 38973 6199 34911731
Chronic kidney disease 17.82 10.72 92 38909 41118 34876812
Cardiac failure congestive 17.81 10.72 156 38845 83114 34834816
Cardiomyopathy 17.80 10.72 50 38951 16758 34901172
Thrombocytopenia 17.73 10.72 102 38899 156145 34761785
Bundle branch block left 17.43 10.72 27 38974 5952 34911978
Left ventricular hypertrophy 17.42 10.72 32 38969 8098 34909832
Cytomegalovirus infection 17.22 10.72 4 38997 26131 34891799
Chromaturia 17.19 10.72 45 38956 14475 34903455
Renal impairment 17.17 10.72 171 38830 94342 34823588
Angiopathy 16.82 10.72 22 38979 4151 34913779
Erectile dysfunction 16.81 10.72 56 38945 20581 34897349
Sleep apnoea syndrome 16.43 10.72 55 38946 20266 34897664
Muscle spasms 16.29 10.72 141 38860 74860 34843070
Intentional product use issue 16.25 10.72 26 38975 59790 34858140
Platelet count decreased 15.91 10.72 74 38927 119643 34798287
Supraventricular tachycardia 15.85 10.72 37 38964 11080 34906850
Intraocular pressure decreased 15.67 10.72 5 38996 68 34917862
Diabetic ketoacidosis 15.65 10.72 50 38951 17982 34899948
Breast cyst 15.59 10.72 4 38997 23 34917907
Dyslipidaemia 15.45 10.72 29 38972 7459 34910471
Glutamate dehydrogenase increased 15.32 10.72 3 38998 3 34917927
Chondrocalcinosis 15.21 10.72 8 38993 410 34917520
Hepatitis acute 15.14 10.72 29 38972 7572 34910358
Procedural haemorrhage 14.97 10.72 16 38985 2441 34915489
Ketonuria 14.91 10.72 9 38992 602 34917328
Carotid arteriosclerosis 14.82 10.72 14 38987 1844 34916086
Leukopenia 14.68 10.72 30 38971 62826 34855104
Weight decreased 14.61 10.72 277 38724 176024 34741906
Post procedural fistula 14.59 10.72 5 38996 86 34917844
Hepatic function abnormal 14.55 10.72 92 38909 44271 34873659
Hepatitis 14.53 10.72 59 38942 23845 34894085
Respiratory failure 14.49 10.72 67 38934 108505 34809425
Testicular oedema 14.43 10.72 5 38996 89 34917841
Hypercreatinaemia 14.39 10.72 6 38995 180 34917750
Lipase increased 14.16 10.72 32 38969 9384 34908546
Loss of personal independence in daily activities 13.94 10.72 10 38991 33169 34884761
Malignant neoplasm progression 13.83 10.72 51 38950 87995 34829935
Respiratory arrest 13.81 10.72 7 38994 28036 34889894
Diet noncompliance 13.80 10.72 6 38995 200 34917730
Retinal vein occlusion 13.80 10.72 13 38988 1706 34916224
Drug resistance 13.50 10.72 6 38995 25921 34892009
Needle track marks 13.31 10.72 4 38997 44 34917886
Blood cholesterol abnormal 13.25 10.72 13 38988 1793 34916137
Coma acidotic 13.25 10.72 3 38998 9 34917921
Serotonin syndrome 13.23 10.72 3 38998 19930 34898000
Foetal exposure during pregnancy 12.97 10.72 14 38987 38087 34879843
Cerebrovascular accident 12.86 10.72 148 38853 84663 34833267
Blood glucose decreased 12.69 10.72 38 38963 13199 34904731
Angina unstable 12.67 10.72 35 38966 11618 34906312
Febrile neutropenia 12.65 10.72 95 38906 136754 34781176
Pancytopenia 12.53 10.72 59 38942 95098 34822832
Pyrexia 12.45 10.72 280 38721 332733 34585197
Obesity 12.37 10.72 37 38964 12841 34905089
Optic neuropathy 12.33 10.72 13 38988 1952 34915978
Anaemia macrocytic 12.27 10.72 16 38985 3010 34914920
Glomerular filtration rate decreased 12.23 10.72 37 38964 12924 34905006
Loss of bladder sensation 12.17 10.72 4 38997 60 34917870
Lung disorder 12.03 10.72 73 38928 34623 34883307
Rheumatoid arthritis 11.99 10.72 15 38986 38223 34879707
Coronary artery occlusion 11.99 10.72 33 38968 10929 34907001
Fanconi syndrome 11.92 10.72 12 38989 1708 34916222
Nervousness 11.91 10.72 36 38965 12570 34905360
General physical health deterioration 11.87 10.72 89 38912 128180 34789750
Abdominal pain upper 11.86 10.72 127 38874 71363 34846567
Sepsis 11.72 10.72 124 38877 166437 34751493
Medulloblastoma 11.71 10.72 4 38997 68 34917862
Drug ineffective for unapproved indication 11.56 10.72 6 38995 23709 34894221
Radicular pain 11.45 10.72 4 38997 73 34917857
Drug-disease interaction 11.41 10.72 7 38994 482 34917448
Neurotoxicity 11.39 10.72 3 38998 18007 34899923
Glucose tolerance impaired 11.18 10.72 16 38985 3288 34914642
Retinal disorder 11.09 10.72 9 38992 968 34916962
Ureteral disorder 11.02 10.72 5 38996 185 34917745
Bilirubinuria 10.95 10.72 3 38998 23 34917907
COVID-19 10.86 10.72 47 38954 77503 34840427
Psychotic disorder 10.76 10.72 7 38994 24445 34893485

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
Pancreatitis acute 405.34 10.09 326 62487 49278 79632297
Rhabdomyolysis 254.83 10.09 358 62455 102773 79578802
Pancreatitis 235.17 10.09 280 62533 68295 79613280
High density lipoprotein decreased 227.74 10.09 98 62715 4557 79677018
Blood triglycerides increased 212.74 10.09 157 62656 20883 79660692
Acute kidney injury 190.41 10.09 861 61952 518543 79163032
Hypertriglyceridaemia 156.35 10.09 107 62706 12633 79668942
Myalgia 152.31 10.09 403 62410 185238 79496337
Myocardial infarction 145.29 10.09 394 62419 183735 79497840
Blood creatine phosphokinase increased 140.78 10.09 214 62599 65876 79615699
Coronary artery disease 136.64 10.09 210 62603 65264 79616311
Off label use 104.01 10.09 367 62446 906848 78774727
Synovitis 101.27 10.09 4 62809 150730 79530845
Renal failure 96.06 10.09 362 62451 200606 79480969
Drug abuse 81.07 10.09 15 62798 162676 79518899
Contraindicated product administered 75.41 10.09 16 62797 157522 79524053
Drug ineffective 71.49 10.09 529 62284 1080384 78601191
Treatment failure 69.06 10.09 24 62789 170462 79511113
Hand deformity 65.83 10.09 4 62809 103915 79577660
International normalised ratio increased 65.44 10.09 180 62633 84541 79597034
Hepatic steatosis 63.71 10.09 110 62703 37628 79643947
Drug interaction 63.35 10.09 550 62263 414633 79266942
Rheumatoid arthritis 62.38 10.09 44 62769 208426 79473149
Glycosylated haemoglobin increased 61.66 10.09 76 62737 19184 79662391
Pulmonary valve disease 59.77 10.09 18 62795 290 79681285
Systemic lupus erythematosus 58.60 10.09 12 62801 121137 79560438
Pemphigus 57.06 10.09 6 62807 99576 79581999
Therapeutic product effect decreased 56.85 10.09 29 62784 163834 79517741
Pericardial disease 55.81 10.09 20 62793 567 79681008
Pancreatitis necrotising 55.62 10.09 36 62777 3872 79677703
Glossodynia 54.88 10.09 8 62805 103329 79578246
Hepatic function abnormal 54.17 10.09 153 62660 72954 79608621
Maternal exposure during pregnancy 52.31 10.09 21 62792 136517 79545058
Infusion related reaction 49.77 10.09 65 62748 230172 79451403
Diabetes mellitus inadequate control 49.44 10.09 77 62736 24187 79657388
Mitral valve disease 49.35 10.09 31 62782 3166 79678409
Acute myocardial infarction 49.25 10.09 153 62660 76883 79604692
Blood glucose increased 49.11 10.09 200 62613 114775 79566800
Confabulation 47.47 10.09 17 62796 481 79681094
Hyperlipidaemia 46.61 10.09 78 62735 26015 79655560
Myopathy 44.35 10.09 67 62746 20496 79661079
Stenosis 43.83 10.09 26 62787 2396 79679179
Physical examination abnormal 42.98 10.09 14 62799 295 79681280
Dyslipidaemia 42.33 10.09 49 62764 11584 79669991
Drug-induced liver injury 41.97 10.09 131 62682 65986 79615589
Renal impairment 41.67 10.09 239 62574 157544 79524031
Pericarditis 41.64 10.09 15 62798 104221 79577354
Joint swelling 41.36 10.09 105 62708 288541 79393034
Wound 41.14 10.09 20 62793 116159 79565416
Arthropathy 40.36 10.09 48 62765 177063 79504512
Infection 40.26 10.09 81 62732 241631 79439944
Hypersensitivity 40.26 10.09 92 62721 262147 79419428
Jaundice 39.86 10.09 112 62701 53237 79628338
Vulvovaginal burning sensation 39.13 10.09 21 62792 1596 79679979
Apolipoprotein A-I decreased 38.89 10.09 8 62805 21 79681554
Cardiac failure congestive 37.14 10.09 215 62598 142187 79539388
Rheumatoid factor positive 35.89 10.09 3 62810 59836 79621739
Gamma-glutamyltransferase increased 35.31 10.09 109 62704 54571 79627004
Hypoglycaemia 35.21 10.09 166 62647 101428 79580147
Fall 35.11 10.09 559 62254 487070 79194505
Cardiac discomfort 34.78 10.09 18 62795 1270 79680305
Rhinalgia 34.17 10.09 22 62791 2345 79679230
Diabetic metabolic decompensation 33.98 10.09 25 62788 3307 79678268
Erectile dysfunction 33.37 10.09 49 62764 14615 79666960
Electrocardiogram Q wave abnormal 33.25 10.09 14 62799 616 79680959
Fibrillary glomerulonephritis 32.71 10.09 8 62805 55 79681520
Rectosigmoid cancer 32.11 10.09 11 62802 272 79681303
Vulvovaginal pruritus 32.03 10.09 22 62791 2611 79678964
Metabolic syndrome 31.24 10.09 22 62791 2718 79678857
Euglycaemic diabetic ketoacidosis 30.39 10.09 32 62781 6812 79674763
Cholelithiasis 30.39 10.09 101 62712 52563 79629012
Alopecia 30.25 10.09 88 62725 231267 79450308
Pancreatic neoplasm 29.77 10.09 17 62796 1459 79680116
Mitral valve incompetence 29.72 10.09 68 62745 28497 79653078
Hepatojugular reflux 29.60 10.09 13 62800 635 79680940
Blood triglycerides abnormal 29.56 10.09 12 62801 481 79681094
Blood creatinine increased 29.36 10.09 216 62597 154841 79526734
Skin weeping 29.34 10.09 15 62798 1032 79680543
Lichen nitidus 29.29 10.09 8 62805 89 79681486
Hepatorenal failure 29.18 10.09 16 62797 1269 79680306
Product use issue 28.76 10.09 78 62735 209744 79471831
Carotid artery stenosis 28.75 10.09 35 62778 8723 79672852
Product use in unapproved indication 28.70 10.09 101 62712 250258 79431317
Psoriasis 28.61 10.09 143 62670 89444 79592131
Photosensitivity reaction 28.61 10.09 56 62757 21071 79660504
Myoglobin blood increased 28.49 10.09 22 62791 3129 79678446
Asthenia 28.42 10.09 563 62250 511126 79170449
Toxicity to various agents 28.31 10.09 205 62608 421335 79260240
Folliculitis 27.80 10.09 5 62808 55375 79626200
Chromaturia 27.58 10.09 62 62751 25684 79655891
Nasopharyngitis 27.40 10.09 105 62708 253776 79427799
Stomatitis 27.25 10.09 46 62767 146711 79534864
Wheezing 27.24 10.09 31 62782 116633 79564942
Chronic kidney disease 26.61 10.09 113 62700 66041 79615534
Irritable bowel syndrome 26.54 10.09 8 62805 62233 79619342
Low density lipoprotein increased 25.97 10.09 33 62780 8589 79672986
Cerebrovascular accident 25.88 10.09 210 62603 155082 79526493
Mobility decreased 25.86 10.09 35 62778 122140 79559435
Glycogen storage disease type V 25.68 10.09 6 62807 33 79681542
Ischaemic cardiomyopathy 25.66 10.09 31 62782 7664 79673911
Total cholesterol/HDL ratio abnormal 25.62 10.09 7 62806 78 79681497
Orbital compartment syndrome 25.62 10.09 7 62806 78 79681497
Lichenoid keratosis 25.59 10.09 23 62790 4034 79677541
Impaired healing 25.55 10.09 19 62794 87636 79593939
Medulloblastoma 24.99 10.09 7 62806 86 79681489
Drug intolerance 24.94 10.09 115 62698 264004 79417571
Libido disorder 24.60 10.09 9 62804 271 79681304
Subacute kidney injury 24.07 10.09 5 62808 14 79681561
Sleep disorder due to general medical condition, insomnia type 24.01 10.09 3 62810 43553 79638022
Nephrosclerosis 23.95 10.09 16 62797 1814 79679761
Ventricular arrhythmia 23.77 10.09 32 62781 8808 79672767
Paranasal sinus discomfort 23.75 10.09 23 62790 4433 79677142
Ectopic gastric mucosa 23.57 10.09 5 62808 16 79681559
Left ventricular dysfunction 23.45 10.09 49 62764 19312 79662263
Echocardiogram abnormal 23.36 10.09 17 62796 2211 79679364
Hyperglycaemia 22.97 10.09 113 62700 70222 79611353
Occult blood 22.40 10.09 15 62798 1708 79679867
Myotonia 22.05 10.09 8 62805 235 79681340
Hepatitis acute 22.03 10.09 42 62771 15500 79666075
Pulmonary embolism 21.88 10.09 219 62594 171435 79510140
Ureteric injury 21.65 10.09 7 62806 144 79681431
Chest pain 21.17 10.09 326 62487 281978 79399597
Blood cholesterol abnormal 21.15 10.09 19 62794 3331 79678244
Asthma 21.03 10.09 47 62766 135048 79546527
Systolic dysfunction 21.01 10.09 20 62793 3775 79677800
Cholestasis 20.18 10.09 88 62725 52021 79629554
Change of bowel habit 20.16 10.09 17 62796 2740 79678835
Tricuspid valve incompetence 19.49 10.09 46 62767 19666 79661909
Alkalosis hypochloraemic 19.49 10.09 9 62804 495 79681080
Left ventricular hypertrophy 19.38 10.09 33 62780 11158 79670417
Muscle injury 19.37 10.09 7 62806 48554 79633021
Discomfort 19.31 10.09 44 62769 125573 79556002
Cytomegalovirus infection 19.07 10.09 5 62808 42639 79638936
Increased appetite 19.03 10.09 34 62779 11944 79669631
Intentional overdose 18.95 10.09 34 62779 105926 79575649
Diastolic dysfunction 18.88 10.09 32 62781 10779 79670796
Blood triglycerides decreased 18.73 10.09 7 62806 224 79681351
Bundle branch block left 18.70 10.09 33 62780 11480 79670095
Hepatitis 18.53 10.09 90 62723 55637 79625938
Lower respiratory tract infection 18.49 10.09 47 62766 129173 79552402
Diabetic ketoacidosis 18.42 10.09 64 62749 34058 79647517
Kidney fibrosis 18.38 10.09 18 62795 3517 79678058
Intentional product use issue 18.35 10.09 60 62753 152052 79529523
Cardiomyopathy 18.24 10.09 57 62756 28717 79652858
Dialysis 18.17 10.09 43 62770 18419 79663156
Angina unstable 17.93 10.09 40 62773 16487 79665088
Anaemia macrocytic 17.78 10.09 22 62791 5575 79676000
Dilatation ventricular 17.73 10.09 19 62794 4125 79677450
Coronary artery occlusion 17.67 10.09 38 62775 15277 79666298
Testicular oedema 17.45 10.09 5 62808 67 79681508
Fibromyalgia 17.43 10.09 15 62798 64325 79617250
Narcotic bowel syndrome 17.42 10.09 7 62806 273 79681302
Glomerular filtration rate decreased 17.29 10.09 48 62765 22654 79658921
Musculoskeletal stiffness 17.23 10.09 75 62738 174933 79506642
Arterial spasm 17.16 10.09 6 62807 158 79681417
Productive cough 17.03 10.09 27 62786 88304 79593271
Chronic cutaneous lupus erythematosus 16.89 10.09 8 62805 466 79681109
Abdominal discomfort 16.77 10.09 122 62691 250605 79430970
Death 16.76 10.09 330 62483 566184 79115391
Swelling 16.74 10.09 101 62712 216610 79464965
Exposure during pregnancy 16.73 10.09 34 62779 101098 79580477
Proteinuria 16.71 10.09 60 62753 32442 79649133
Carotid arteriosclerosis 16.64 10.09 15 62798 2641 79678934
Cardiomegaly 16.52 10.09 52 62761 26300 79655275
Ocular icterus 16.48 10.09 21 62792 5479 79676096
Mucosal dryness 16.45 10.09 17 62796 3542 79678033
Normochromic normocytic anaemia 16.41 10.09 25 62788 7702 79673873
Therapeutic product effect incomplete 16.31 10.09 57 62756 141588 79539987
Aspartate aminotransferase increased 16.29 10.09 174 62639 138467 79543108
Nasal dryness 16.23 10.09 19 62794 4544 79677031
Therapy non-responder 16.16 10.09 30 62783 92275 79589300
Malignant neoplasm progression 16.15 10.09 54 62759 135936 79545639
Haemorrhagic fever 15.94 10.09 4 62809 31 79681544
Blister 15.93 10.09 45 62768 119431 79562144
Hepatocellular injury 15.92 10.09 77 62736 47516 79634059
Diabetes mellitus 15.87 10.09 111 62702 78279 79603296
Hypertonic bladder 15.80 10.09 18 62795 4183 79677392
Xanthoma 15.80 10.09 6 62807 201 79681374
Multiple fractures 15.70 10.09 25 62788 8001 79673574
Cholestatic liver injury 15.02 10.09 19 62794 4922 79676653
Blood urea increased 14.95 10.09 77 62736 48713 79632862
Polymyositis 14.94 10.09 15 62798 3021 79678554
Essential hypertension 14.91 10.09 21 62792 6032 79675543
Injection site extravasation 14.79 10.09 27 62786 9642 79671933
Angina pectoris 14.73 10.09 80 62733 51652 79629923
Acute coronary syndrome 14.46 10.09 43 62770 21090 79660485
Lactic acidosis 14.46 10.09 100 62713 70259 79611316
Anticoagulation drug level above therapeutic 14.45 10.09 16 62797 3604 79677971
Blood cholesterol increased 14.37 10.09 114 62699 83606 79597969
Vascular access site pain 14.36 10.09 5 62808 130 79681445
Supraventricular tachycardia 14.29 10.09 43 62770 21227 79660348
Adrenal adenoma 14.05 10.09 10 62803 1257 79680318
Orthopnoea 14.00 10.09 27 62786 10046 79671529
Rales 13.97 10.09 41 62772 19960 79661615
Platelet count decreased 13.86 10.09 93 62720 194571 79487004
Oedema peripheral 13.77 10.09 277 62536 252011 79429564
Aortic arteriosclerosis 13.76 10.09 25 62788 8893 79672682
Liver disorder 13.76 10.09 101 62712 72316 79609259
Helicobacter gastritis 13.73 10.09 13 62800 2436 79679139
Rash 13.66 10.09 349 62464 578009 79103566
Catheter site thrombosis 13.62 10.09 6 62807 295 79681280
Coronary artery bypass 13.42 10.09 20 62793 6042 79675533
Optic ischaemic neuropathy 13.42 10.09 14 62799 2947 79678628
Post procedural fistula 13.38 10.09 6 62807 308 79681267
Electrocardiogram abnormal 13.35 10.09 36 62777 16701 79664874
Arteriosclerosis 13.35 10.09 38 62775 18189 79663386
Hepatic fibrosis 13.32 10.09 22 62791 7258 79674317
Hypercreatinaemia 13.31 10.09 6 62807 312 79681263
Chondrocalcinosis 13.27 10.09 9 62804 1047 79680528
Blood glucose abnormal 13.10 10.09 27 62786 10539 79671036
Congestive hepatopathy 13.06 10.09 17 62796 4530 79677045
Diabetic neuropathy 13.04 10.09 20 62793 6196 79675379
Meningitis streptococcal 13.01 10.09 5 62808 173 79681402
Glycosuria 13.01 10.09 12 62801 2176 79679399
Paternal exposure during pregnancy 12.97 10.09 4 62809 70 79681505
Intraocular pressure decreased 12.90 10.09 5 62808 177 79681398
Anhedonia 12.86 10.09 33 62780 14865 79666710
Needle track marks 12.82 10.09 4 62809 73 79681502
General physical health deterioration 12.72 10.09 147 62666 275091 79406484
Diet noncompliance 12.60 10.09 7 62806 570 79681005
Drug resistance 12.49 10.09 9 62804 42204 79639371
Grandiosity 12.48 10.09 7 62806 580 79680995
Blood glucose decreased 12.29 10.09 47 62766 26187 79655388
Ketonuria 12.17 10.09 9 62804 1199 79680376
Radicular pain 12.17 10.09 6 62807 382 79681193
Pericardial effusion 12.17 10.09 70 62743 46167 79635408
Thrombocytopenia 12.13 10.09 142 62671 265117 79416458
Nasal discomfort 12.01 10.09 18 62795 5465 79676110
Urticaria 11.96 10.09 91 62722 185110 79496465
Arthralgia 11.96 10.09 351 62462 571452 79110123
Intra-abdominal haematoma 11.92 10.09 13 62800 2878 79678697
Thirst 11.91 10.09 37 62776 18582 79662993
Nervousness 11.86 10.09 55 62758 33360 79648215
Obstructive airways disorder 11.78 10.09 5 62808 31454 79650121
Atypical teratoid/rhabdoid tumour of CNS 11.76 10.09 3 62810 25 79681550
Loss of bladder sensation 11.75 10.09 4 62809 97 79681478
Lipase increased 11.74 10.09 34 62779 16432 79665143
Device dislocation 11.70 10.09 3 62810 25967 79655608
Peripheral swelling 11.70 10.09 146 62667 269471 79412104
Lipids increased 11.60 10.09 10 62803 1661 79679914
Glutamate dehydrogenase increased 11.46 10.09 3 62810 28 79681547
Aortic valve incompetence 11.40 10.09 24 62789 9506 79672069
Sinus congestion 11.33 10.09 38 62775 19858 79661717
Coagulation test abnormal 11.32 10.09 9 62804 1336 79680239
Myositis 11.27 10.09 37 62776 19131 79662444
Urticaria pigmentosa 11.18 10.09 3 62810 31 79681544
Ureteric cancer recurrent 11.18 10.09 3 62810 31 79681544
Bipolar disorder 11.14 10.09 21 62792 7686 79673889
Renal tubular necrosis 11.03 10.09 44 62769 24995 79656580
Blood potassium increased 11.00 10.09 49 62764 29226 79652349
Nephrotic syndrome 10.97 10.09 26 62787 11148 79670427
Enuresis 10.93 10.09 13 62800 3163 79678412
Neurotoxicity 10.91 10.09 6 62807 32512 79649063
Renin decreased 10.89 10.09 4 62809 122 79681453
Cardioactive drug level increased 10.86 10.09 14 62799 3695 79677880
Metabolic acidosis 10.85 10.09 106 62707 82423 79599152
Gastrointestinal haemorrhage 10.83 10.09 170 62643 147549 79534026
Palatal oedema 10.83 10.09 9 62804 1422 79680153
Hepatitis fulminant 10.76 10.09 20 62793 7242 79674333
Hepatic cytolysis 10.62 10.09 46 62767 27105 79654470
Myocardial ischaemia 10.58 10.09 44 62769 25475 79656100
Hypothyroidism 10.49 10.09 74 62739 52318 79629257
Auditory disorder 10.46 10.09 6 62807 519 79681056
Retinal vein occlusion 10.45 10.09 13 62800 3310 79678265
Condition aggravated 10.37 10.09 308 62505 500816 79180759
Fanconi syndrome 10.34 10.09 12 62801 2844 79678731
Recurrence of neuromuscular blockade 10.21 10.09 5 62808 314 79681261
Upper-airway cough syndrome 10.20 10.09 26 62787 11667 79669908
Pain 10.18 10.09 452 62361 703350 78978225
Skin lesion 10.14 10.09 62 62751 41782 79639793
Sleep apnoea syndrome 10.11 10.09 56 62757 36422 79645153
Hyperkalaemia 10.11 10.09 136 62677 114262 79567313

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AB05 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Fibrates
ATC C10BA03 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA09 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 CS M0199111 PPAR alpha
FDA MoA N0000175375 Peroxisome Proliferator-activated Receptor alpha Agonists
CHEBI has role CHEBI:35679 antilipemic drugs
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:176497 geroprotectors
MeSH PA D000963 Antimetabolites
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000175596 Peroxisome Proliferator Receptor alpha Agonist

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

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Hyperlipidemia indication 55822004 DOID:1168
Hypoalphalipoproteinemia indication 190785000
Familial hypercholesterolemia - heterozygous indication 238079002
Mixed hyperlipidemia indication 267434003
Hypertriglyceridemia indication 302870006
At increased risk of coronary heart disease indication 315016007
Agranulocytosis contraindication 17182001 DOID:12987
Myositis contraindication 26889001 DOID:633
Primary biliary cirrhosis contraindication 31712002 DOID:12236
Disorder of gallbladder contraindication 39621005 DOID:0060262
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Leukopenia contraindication 84828003 DOID:615
Disorder of muscle contraindication 129565002 DOID:423
Liver function tests abnormal contraindication 166603001
Acute pancreatitis contraindication 197456007 DOID:2913
Impaired renal function disorder contraindication 197663003
Disease of liver contraindication 235856003 DOID:409
Rhabdomyolysis contraindication 240131006
Calculus in biliary tract contraindication 266474003
Anemia contraindication 271737000 DOID:2355
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Thromboembolic disorder contraindication 371039008
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
145MG TRICOR ABBVIE N021656 Nov. 5, 2004 RX TABLET ORAL 7320802 Feb. 21, 2023 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
48MG TRICOR ABBVIE N021656 Nov. 5, 2004 RX TABLET ORAL 7320802 Feb. 21, 2023 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
120MG FENOGLIDE SALIX N022118 Aug. 10, 2007 RX TABLET ORAL 8124125 Oct. 1, 2024 FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
120MG FENOGLIDE SALIX N022118 Aug. 10, 2007 RX TABLET ORAL 8481078 Oct. 1, 2024 USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
40MG FENOGLIDE SALIX N022118 Aug. 10, 2007 RX TABLET ORAL 8124125 Oct. 1, 2024 FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
40MG FENOGLIDE SALIX N022118 Aug. 10, 2007 RX TABLET ORAL 8481078 Oct. 1, 2024 USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 8026281 April 22, 2025 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 8026281 April 22, 2025 TREATING SEVERE HYPERTRIGLYCERIDEMIA
90MG ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 8026281 April 22, 2025 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 8026281 April 22, 2025 TREATING SEVERE HYPERTRIGLYCERIDEMIA
90MG ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 9314447 May 31, 2033 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG ANTARA (MICRONIZED) LUPIN N021695 Oct. 18, 2013 DISCN CAPSULE ORAL 9314447 May 31, 2033 TREATING SEVERE HYPERTRIGLYCERIDEMIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Peroxisome proliferator-activated receptor alpha Nuclear hormone receptor AGONIST IC50 6 CHEMBL CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 6.22 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR Ki 5.91 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 4.33 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 4.03 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.16 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 5.49 DRUG MATRIX
ATP-binding cassette sub-family G member 2 Transporter IC50 5.29 CHEMBL
Acetylcholinesterase Enzyme IC50 4.81 DRUG MATRIX
Peroxisome proliferator-activated receptor gamma Nuclear hormone receptor EC50 6.24 CHEMBL
Sodium-dependent noradrenaline transporter Transporter Ki 4.67 DRUG MATRIX
Fatty acid-binding protein, liver Unclassified Kd 7.74 CHEMBL
Cruzipain Enzyme IC50 4.21 CHEMBL

External reference:

IDSource
4021098 VUID
N0000148554 NUI
D00565 KEGG_DRUG
4021098 VANDF
C0033228 UMLSCUI
CHEBI:5001 CHEBI
CHEMBL672 ChEMBL_ID
DB01039 DRUGBANK_ID
D011345 MESH_DESCRIPTOR_UI
3339 PUBCHEM_CID
7186 IUPHAR_LIGAND_ID
3996 INN_ID
U202363UOS UNII
8703 RXNORM
12032 MMSL
44688 MMSL
d04286 MMSL
003789 NDDF
108603001 SNOMEDCT_US
386879008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-3173 TABLET 48 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-3173 TABLET 48 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-3189 TABLET 145 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-3189 TABLET 145 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-6122 TABLET 48 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-6122 TABLET 48 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-6123 TABLET 145 mg ORAL NDA 30 sections
Tricor HUMAN PRESCRIPTION DRUG LABEL 1 0074-6123 TABLET 145 mg ORAL NDA 30 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0511 CAPSULE 67 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0511 CAPSULE 67 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0522 CAPSULE 134 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0522 CAPSULE 134 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0533 CAPSULE 200 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-0533 CAPSULE 200 mg ORAL ANDA 12 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1522 TABLET 40 mg ORAL NDA AUTHORIZED GENERIC 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0115-1523 TABLET 120 mg ORAL NDA AUTHORIZED GENERIC 26 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0115-5511 TABLET 54 mg ORAL ANDA 23 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0115-5511 TABLET 54 mg ORAL ANDA 23 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0115-5522 TABLET 160 mg ORAL ANDA 23 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0115-5522 TABLET 160 mg ORAL ANDA 23 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-3065 TABLET, FILM COATED 48 mg ORAL ANDA 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-3066 TABLET, FILM COATED 145 mg ORAL ANDA 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-4390 TABLET 40 mg ORAL ANDA 27 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-4391 TABLET 120 mg ORAL ANDA 27 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-7100 TABLET, FILM COATED 54 mg ORAL ANDA 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-7101 TABLET, FILM COATED 160 mg ORAL ANDA 26 sections
fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8270 TABLET 160 mg ORAL ANDA 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6810 TABLET 160 mg ORAL ANDA 24 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7128 TABLET 160 mg ORAL ANDA 24 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7161 TABLET 145 mg ORAL ANDA 25 sections