fenofibrate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
BA (Bioavailability) 60 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.588 Moderate 0.76
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.902 Moderate 0.76
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 5.483 10^-6 cm/s Moderate 0.76
dh-clint Dog hepatocyte intrinsic clearance 43.053 uL/min/10^6 cells Moderate 0.76
dppb Dog plasma protein binding (% unbound) 0.220 % Moderate 0.76
fcs-ppb Fetal calf serum protein binding (% unbound) 0.300 % Moderate 0.76
herg hERG pIC50 4.984 pIC50 Moderate 0.76
hh-clint Human hepatocyte intrinsic clearance 294.442 uL/min/10^6 cells Moderate 0.76
hlm-clint Human liver microsomal intrinsic clearance 205.589 uL/min/mg protein Moderate 0.76
hppb Human plasma protein binding (% unbound) 0.430 % Moderate 0.76
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DDR1,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PRKDC,STK33,TTK 22
kinase-selectivity-class ACVR2B,GRK2,PDK4 3
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.207 Moderate 0.76
mh-clint Mouse hepatocyte intrinsic clearance 181.970 Moderate 0.76
mppb Mouse plasma protein binding (% unbound) 0.460 Moderate 0.76
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.361 Moderate 0.76
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 0.560 % Moderate 0.76
rh-clint Rat hepatocyte intrinsic clearance 289.068 uL/min/10^6 cells Moderate 0.76
rh-fuinc Rat hepatocyte fraction unbound in incubation 4.250 % Moderate 0.76
rppb Rat plasma protein binding (% unbound) 0.420 % Moderate 0.76
solubility-dd Solubility at pH 7.4 in DMSO 1.866 uM Moderate 0.76

Approvals:

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

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 268.53 11.52 198 36757 51058 90540434
Acute kidney injury 239.83 11.52 451 36504 319936 90271556
Pancreatitis acute 216.98 11.52 145 36810 31970 90559522
Hepatic function abnormal 161.62 11.52 141 36814 46147 90545345
Myalgia 121.51 11.52 239 36716 174886 90416606
Blood triglycerides increased 112.33 11.52 70 36885 13691 90577801
Pemphigus 112.09 11.52 5 36950 326859 90264633
Drug interaction 109.81 11.52 303 36652 276150 90315342
Systemic lupus erythematosus 108.26 11.52 11 36944 361885 90229607
Synovitis 106.99 11.52 7 36948 329745 90261747
Glossodynia 103.90 11.52 7 36948 321772 90269720
Pericarditis 96.50 11.52 3 36952 270148 90321344
High density lipoprotein decreased 94.82 11.52 37 36918 2614 90588878
Renal failure 87.47 11.52 176 36779 130831 90460661
Blood creatine phosphokinase increased 83.02 11.52 85 36870 33938 90557554
International normalised ratio increased 82.28 11.52 99 36856 47217 90544275
Wound 81.44 11.52 13 36942 302967 90288525
Contraindicated product administered 81.13 11.52 16 36939 320123 90271369
Hypertriglyceridaemia 76.96 11.52 45 36910 7844 90583648
Pancreatitis 76.93 11.52 117 36838 69709 90521783
Pancreatitis haemorrhagic 75.52 11.52 22 36933 627 90590865
Jaundice 75.31 11.52 79 36876 32438 90559054
Lactic acidosis 72.51 11.52 96 36859 50367 90541125
Glycosylated haemoglobin increased 65.87 11.52 53 36902 15509 90575983
Infusion related reaction 65.36 11.52 45 36910 416735 90174757
Impaired healing 65.34 11.52 9 36946 234190 90357302
Arthropathy 65.21 11.52 34 36921 366208 90225284
Pancreatitis necrotising 63.77 11.52 27 36928 2354 90589138
Fall 63.02 11.52 373 36582 481437 90110055
Confabulation 61.08 11.52 16 36939 304 90591188
Abdominal discomfort 59.69 11.52 64 36891 477264 90114228
Mobility decreased 56.67 11.52 16 36939 250718 90340774
Therapeutic product effect decreased 55.26 11.52 22 36933 277549 90313943
Treatment failure 54.41 11.52 28 36927 303900 90287592
Hepatic enzyme increased 53.87 11.52 41 36914 360695 90230797
Irritable bowel syndrome 53.31 11.52 10 36945 207438 90384054
Myopathy 52.93 11.52 44 36911 13474 90578018
Stomatitis 52.71 11.52 23 36932 274675 90316817
Blood alkaline phosphatase abnormal 52.15 11.52 20 36935 1348 90590144
Vulvovaginal burning sensation 51.98 11.52 24 36931 2571 90588921
Blood albumin abnormal 51.82 11.52 19 36936 1130 90590362
Musculoskeletal toxicity 51.51 11.52 16 36939 570 90590922
Chest wall mass 50.72 11.52 16 36939 600 90590892
Scan abnormal 50.19 11.52 16 36939 621 90590871
Rheumatoid arthritis 49.47 11.52 45 36910 362569 90228923
Vulvovaginal pruritus 47.67 11.52 26 36929 3967 90587525
Rhinalgia 46.46 11.52 22 36933 2496 90588996
Alopecia 46.19 11.52 82 36873 494989 90096503
Maternal exposure during pregnancy 45.29 11.52 48 36907 360015 90231477
Hepatorenal failure 44.78 11.52 15 36940 682 90590810
Joint swelling 44.62 11.52 86 36869 503214 90088278
Pulmonary embolism 43.78 11.52 135 36820 130685 90460807
Myoglobin blood increased 42.90 11.52 18 36937 1534 90589958
Wheezing 42.50 11.52 22 36933 238058 90353434
Blood glucose increased 42.39 11.52 109 36846 95137 90496355
Rectosigmoid cancer 41.99 11.52 11 36944 209 90591283
Cholestasis 40.22 11.52 61 36894 36238 90555254
Hypersensitivity 40.02 11.52 78 36877 454599 90136893
Discomfort 39.90 11.52 32 36923 274303 90317189
Psoriasis 39.23 11.52 141 36814 147613 90443879
Type 2 diabetes mellitus 39.00 11.52 17 36938 203227 90388265
Blood bilirubin abnormal 38.83 11.52 18 36937 1946 90589546
Blood calcium abnormal 38.72 11.52 18 36937 1959 90589533
Swelling 38.54 11.52 70 36885 418988 90172504
Sleep disorder due to general medical condition, insomnia type 38.21 11.52 4 36951 128690 90462802
Glomerular filtration rate increased 38.01 11.52 18 36937 2042 90589450
Distributive shock 37.33 11.52 21 36934 3403 90588089
Photosensitivity reaction 37.25 11.52 41 36914 17766 90573726
Nephrosclerosis 37.21 11.52 15 36940 1154 90590338
Renal impairment 36.40 11.52 110 36845 105311 90486181
Product use issue 36.14 11.52 49 36906 329870 90261622
Proteinuria 36.09 11.52 46 36909 23245 90568247
Joint range of motion decreased 36.02 11.52 6 36949 135637 90455855
Hyporesponsive to stimuli 35.69 11.52 16 36939 1601 90589891
Hyponatraemia 35.08 11.52 127 36828 133411 90458081
Injection site extravasation 34.57 11.52 29 36926 8990 90582502
Bursitis 34.57 11.52 6 36949 131648 90459844
Orbital compartment syndrome 34.12 11.52 8 36947 94 90591398
Fibromyalgia 34.02 11.52 21 36934 206248 90385244
Neutrophil count abnormal 33.69 11.52 21 36934 4107 90587385
Ill-defined disorder 33.12 11.52 17 36938 184874 90406618
Multiple fractures 33.10 11.52 29 36926 9533 90581959
Skin weeping 32.79 11.52 18 36937 2782 90588710
Lichen nitidus 32.69 11.52 8 36947 114 90591378
Injury 32.68 11.52 20 36935 197329 90394163
Dilatation ventricular 32.68 11.52 17 36938 2359 90589133
Hepatic steatosis 32.62 11.52 56 36899 36889 90554603
Paranasal sinus discomfort 32.51 11.52 24 36931 6186 90585306
Lymphopenia 32.05 11.52 43 36912 22838 90568654
Apolipoprotein A-I decreased 32.04 11.52 6 36949 20 90591472
Alkalosis hypochloraemic 31.64 11.52 9 36946 235 90591257
Hyperglycaemia 31.07 11.52 66 36889 50904 90540588
Hepatic fibrosis 30.98 11.52 20 36935 4155 90587337
Lower respiratory tract infection 30.85 11.52 34 36921 250625 90340867
Kidney fibrosis 30.77 11.52 16 36939 2218 90589274
Somnolence 30.63 11.52 167 36788 208917 90382575
Total cholesterol/HDL ratio abnormal 30.27 11.52 7 36948 77 90591415
Wound infection 29.87 11.52 4 36951 106398 90485094
Urinary tract infection 29.78 11.52 220 36735 305412 90286080
Hypoglycaemia 29.10 11.52 78 36877 69770 90521722
Myotonia 28.97 11.52 8 36947 187 90591305
Lichenoid keratosis 28.87 11.52 16 36939 2518 90588974
Liver injury 28.64 11.52 17 36938 170550 90420942
Blood creatinine abnormal 28.62 11.52 19 36936 4138 90587354
Diabetes mellitus 28.61 11.52 74 36881 64801 90526691
Hepatic failure 28.45 11.52 55 36900 39673 90551819
Dyslipidaemia 27.88 11.52 27 36928 10080 90581412
Change of bowel habit 27.63 11.52 15 36940 2268 90589224
Apolipoprotein B increased 27.36 11.52 5 36950 14 90591478
Grip strength decreased 27.17 11.52 3 36952 92573 90498919
Rhabdoid tumour 26.94 11.52 6 36949 55 90591437
Ocular icterus 26.94 11.52 18 36937 3962 90587530
Off label use 26.88 11.52 304 36651 1101948 89489544
Narcotic bowel syndrome 26.38 11.52 7 36948 140 90591352
Alanine aminotransferase abnormal 26.25 11.52 20 36935 5406 90586086
Congestive hepatopathy 26.20 11.52 16 36939 3017 90588475
Arterial spasm 26.12 11.52 6 36949 64 90591428
Aortic arteriosclerosis 25.99 11.52 23 36932 7661 90583831
Blister 25.82 11.52 40 36915 254958 90336534
Mucosal dryness 25.56 11.52 16 36939 3151 90588341
Gastrointestinal haemorrhage 25.56 11.52 88 36867 90160 90501332
Hypertonic bladder 25.50 11.52 18 36937 4330 90587162
Hepatic necrosis 25.30 11.52 21 36934 6417 90585075
Metabolic acidosis 25.06 11.52 64 36891 55612 90535880
Gastrointestinal disorder 24.37 11.52 42 36913 256645 90334847
Orthopnoea 24.20 11.52 21 36934 6814 90584678
Peripheral venous disease 23.93 11.52 3 36952 83918 90507574
Product dose omission issue 22.97 11.52 200 36755 291487 90300005
Normochromic normocytic anaemia 22.92 11.52 18 36937 5084 90586408
Increased appetite 22.74 11.52 26 36929 11739 90579753
Infection 22.61 11.52 74 36881 362020 90229472
Ophthalmoplegia 22.59 11.52 12 36943 1737 90589755
Nasopharyngitis 22.23 11.52 88 36867 407016 90184476
Blood creatinine increased 22.17 11.52 91 36864 101295 90490197
Grandiosity 21.25 11.52 7 36948 302 90591190
Drug reaction with eosinophilia and systemic symptoms 21.19 11.52 51 36904 42707 90548785
Sleep disorder 21.08 11.52 30 36925 198000 90393492
Pseudohallucination 20.60 11.52 6 36949 171 90591321
Medulloblastoma 20.52 11.52 5 36950 70 90591422
Arachnoiditis 20.33 11.52 8 36947 578 90590914
Abnormal loss of weight 20.29 11.52 19 36936 6804 90584688
Hyperthermia malignant 19.92 11.52 10 36945 1288 90590204
Nasal discomfort 19.55 11.52 17 36938 5531 90585961
Nasal dryness 19.46 11.52 17 36938 5566 90585926
Hepatocellular injury 19.42 11.52 39 36916 28919 90562573
Road traffic accident 19.11 11.52 10 36945 107616 90483876
Upper-airway cough syndrome 19.03 11.52 27 36928 15108 90576384
Hyperkalaemia 18.97 11.52 64 36891 64900 90526592
Musculoskeletal stiffness 18.92 11.52 60 36895 296472 90295020
Hypokinetic dysarthria 18.92 11.52 4 36951 28 90591464
Hepatic cytolysis 18.80 11.52 40 36915 30876 90560616
White blood cell count abnormal 18.76 11.52 19 36936 7485 90584007
Diabetic metabolic decompensation 18.66 11.52 11 36944 1946 90589546
Drug intolerance 18.45 11.52 107 36848 447484 90144008
Intentional product use issue 18.38 11.52 38 36917 216854 90374638
Phospholipidosis 18.35 11.52 6 36949 253 90591239
Mitral valve disease 18.26 11.52 12 36943 2570 90588922
Hypomagnesaemia 18.23 11.52 43 36912 35545 90555947
General physical health deterioration 17.99 11.52 79 36876 355036 90236456
Live birth 17.95 11.52 5 36950 79102 90512390
Vascular access site pain 17.88 11.52 7 36948 499 90590993
Haemoglobin abnormal 17.79 11.52 18 36937 7082 90584410
Asthenia 17.77 11.52 311 36644 533440 90058052
Urea cycle disorder 17.74 11.52 4 36951 39 90591453
Intra-abdominal haematoma 17.73 11.52 11 36944 2133 90589359
Aphthous ulcer 17.68 11.52 28 36927 17259 90574233
Pulmonary fibrosis 17.64 11.52 11 36944 107492 90484000
Gamma-glutamyltransferase increased 17.46 11.52 44 36911 37908 90553584
Diabetes mellitus inadequate control 17.39 11.52 29 36926 18655 90572837
Chronic cutaneous lupus erythematosus 17.32 11.52 8 36947 858 90590634
Dehydration 17.26 11.52 137 36818 194310 90397182
Vasoconstriction 17.15 11.52 8 36947 877 90590615
Delusional disorder, persecutory type 16.90 11.52 6 36949 325 90591167
Violence-related symptom 16.60 11.52 7 36948 604 90590888
Pancreatitis relapsing 16.54 11.52 9 36946 1367 90590125
Cholestatic liver injury 16.21 11.52 13 36942 3784 90587708
Thirst 16.12 11.52 26 36929 16269 90575223
Hepatitis acute 16.08 11.52 21 36934 10866 90580626
Peripheral motor neuropathy 16.01 11.52 10 36945 1963 90589529
Epileptic encephalopathy 15.96 11.52 6 36949 383 90591109
Gait inability 15.77 11.52 22 36933 146434 90445058
Nystagmus 15.74 11.52 17 36938 7210 90584282
Shock haemorrhagic 15.62 11.52 22 36933 12223 90579269
Macule 15.54 11.52 11 36944 2658 90588834
Psoriatic arthropathy 15.42 11.52 45 36910 228290 90363202
Dermatomyositis 15.38 11.52 12 36943 3358 90588134
Night sweats 15.25 11.52 18 36937 128748 90462744
Hypersensitivity vasculitis 15.18 11.52 13 36942 4146 90587346
Blood triglycerides decreased 15.12 11.52 4 36951 79 90591413
Polymyositis 15.10 11.52 10 36945 2169 90589323
Renal colic 15 11.52 9 36946 1644 90589848
Catheter site thrombosis 14.96 11.52 6 36949 456 90591036
Renal phospholipidosis 14.85 11.52 5 36950 231 90591261
Alanine aminotransferase 14.72 11.52 4 36951 88 90591404
Nicotinic acid deficiency 14.55 11.52 4 36951 92 90591400
Sciatica 14.51 11.52 12 36943 101370 90490122
Euglycaemic diabetic ketoacidosis 14.24 11.52 15 36940 6186 90585306
Muscle contracture 14.20 11.52 9 36946 1812 90589680
Diabetic ketoacidosis 14.18 11.52 31 36924 24376 90567116
Cardiac arrest 14.15 11.52 82 36873 104853 90486639
Renin decreased 13.94 11.52 4 36951 108 90591384
Diarrhoea 13.89 11.52 490 36465 938700 89652792
Cholecystitis infective 13.88 11.52 9 36946 1883 90589609
Cholelithiasis 13.83 11.52 50 36905 52456 90539036
Haematoma 13.71 11.52 41 36914 39007 90552485
Quadriparesis 13.68 11.52 10 36945 2539 90588953
Hip arthroplasty 13.65 11.52 7 36948 76201 90515291
Dyskinesia 13.44 11.52 39 36916 36495 90554997
Chronic kidney disease 13.39 11.52 48 36907 50143 90541349
Obesity 13.32 11.52 14 36941 105493 90485999
Urticaria 13.29 11.52 74 36881 312660 90278832
Metastases to bone marrow 13.26 11.52 6 36949 613 90590879
Multiple organ dysfunction syndrome 13.14 11.52 59 36896 68277 90523215
Toxic shock syndrome 13.03 11.52 7 36948 1037 90590455
Livedo reticularis 13.01 11.52 11 36944 3448 90588044
Inflammation 12.95 11.52 34 36921 178558 90412934
Altered state of consciousness 12.91 11.52 35 36920 31497 90559995
Product residue present 12.86 11.52 12 36943 4279 90587213
Endocrine ophthalmopathy 12.84 11.52 7 36948 1067 90590425
Adenocarcinoma of colon 12.82 11.52 10 36945 2796 90588696
Hypokinesia 12.82 11.52 23 36932 15674 90575818
Neutropenia 12.72 11.52 144 36811 224760 90366732
Drug ineffective 12.66 11.52 450 36505 1383848 89207644
Glossitis 12.66 11.52 11 36944 3576 90587916
Low density lipoprotein increased 12.57 11.52 16 36939 8069 90583423
Pancoast's syndrome 12.52 11.52 3 36952 39 90591453
Myocardial infarction 12.50 11.52 80 36875 105892 90485600
Hypotension 12.43 11.52 194 36761 325203 90266289
Insulin resistance 12.35 11.52 7 36948 1151 90590341
Cholecystitis acute 12.15 11.52 17 36938 9387 90582105
Blood triglycerides abnormal 11.95 11.52 5 36950 423 90591069
Haemolysis 11.93 11.52 16 36939 8494 90582998
Therapy cessation 11.67 11.52 37 36918 36324 90555168
Haematoma muscle 11.65 11.52 8 36947 1842 90589650

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 257.07 11.38 220 36266 33344 42551505
High density lipoprotein decreased 161.86 11.38 75 36411 3822 42581027
Blood creatine phosphokinase increased 107.60 11.38 167 36319 48171 42536678
Hypertriglyceridaemia 104.31 11.38 79 36407 10047 42574802
Rhabdomyolysis 87.49 11.38 201 36285 77818 42507031
Blood triglycerides increased 82.57 11.38 84 36402 15812 42569037
Pancreatitis 76.77 11.38 135 36351 43133 42541716
Pericardial disease 76.07 11.38 25 36461 497 42584352
Pulmonary valve disease 68.82 11.38 22 36464 399 42584450
Hepatic function abnormal 68.18 11.38 142 36344 51425 42533424
Stenosis 61.93 11.38 32 36454 2069 42582780
Myalgia 59.26 11.38 199 36287 95881 42488968
Drug abuse 55.69 11.38 11 36475 104760 42480089
Physical examination abnormal 55.01 11.38 19 36467 442 42584407
Acute kidney injury 54.57 11.38 516 35970 366821 42218028
Electrocardiogram Q wave abnormal 52.28 11.38 19 36467 515 42584334
Echocardiogram abnormal 51.36 11.38 24 36462 1246 42583603
Off label use 50.66 11.38 330 36156 638005 41946844
Drug-induced liver injury 48.96 11.38 104 36382 38169 42546680
Hepatojugular reflux 47.84 11.38 19 36467 660 42584189
Cardiac discomfort 46.33 11.38 19 36467 718 42584131
Gamma-glutamyltransferase increased 43.54 11.38 90 36396 32407 42552442
Metabolic syndrome 41.28 11.38 24 36462 1959 42582890
Occult blood 41.01 11.38 19 36467 967 42583882
Systolic dysfunction 36.55 11.38 26 36460 3002 42581847
Libido disorder 35.85 11.38 13 36473 350 42584499
Helicobacter gastritis 35.26 11.38 19 36467 1338 42583511
Glycogen storage disease type V 34.91 11.38 8 36478 36 42584813
Diabetic metabolic decompensation 34.88 11.38 22 36464 2080 42582769
Carotid artery stenosis 34.36 11.38 32 36454 5404 42579445
Ventricular arrhythmia 34.10 11.38 34 36452 6245 42578604
Rales 33.56 11.38 45 36441 11355 42573494
Glycosylated haemoglobin increased 33.52 11.38 48 36438 12876 42571973
Left ventricular dysfunction 33.25 11.38 45 36441 11456 42573393
Pancreatic neoplasm 32.11 11.38 16 36470 958 42583891
Hepatic steatosis 31.84 11.38 62 36424 21386 42563463
Needle track marks 31.68 11.38 8 36478 58 42584791
Fibrillary glomerulonephritis 31.56 11.38 8 36478 59 42584790
Mitral valve disease 30.70 11.38 18 36468 1492 42583357
Carotid arteriosclerosis 30.42 11.38 21 36465 2311 42582538
Subacute kidney injury 30.32 11.38 5 36481 0 42584849
Urine albumin/creatinine ratio decreased 30.28 11.38 7 36479 33 42584816
Psoriasis 29.34 11.38 100 36386 48504 42536345
Acute myocardial infarction 28.64 11.38 112 36374 58053 42526796
Diabetes mellitus inadequate control 28.56 11.38 49 36437 15341 42569508
Drug interaction 28.34 11.38 351 36135 266648 42318201
Euglycaemic diabetic ketoacidosis 27.74 11.38 29 36457 5631 42579218
Coronary artery disease 27.72 11.38 105 36381 53615 42531234
Renal impairment 27.54 11.38 175 36311 110053 42474796
Toxicity to various agents 26.92 11.38 103 36383 229033 42355816
Left ventricular hypertrophy 26.24 11.38 36 36450 9283 42575566
Bundle branch block left 26.21 11.38 30 36456 6446 42578403
Mitral valve incompetence 24.88 11.38 48 36438 16441 42568408
Anaemia macrocytic 24.57 11.38 22 36464 3533 42581316
Diastolic dysfunction 24.38 11.38 30 36456 6953 42577896
Liver disorder 24.31 11.38 82 36404 39562 42545287
Glomerular filtration rate decreased 23.94 11.38 47 36439 16304 42568545
Supraventricular tachycardia 23.67 11.38 40 36446 12368 42572481
Ectopic gastric mucosa 23.40 11.38 5 36481 15 42584834
Ureteric injury 23.35 11.38 6 36480 47 42584802
Pancreatitis necrotising 22.14 11.38 21 36465 3628 42581221
Angiopathy 21.91 11.38 25 36461 5352 42579497
Chronic kidney disease 21.68 11.38 89 36397 47152 42537697
Blood cholesterol abnormal 21.62 11.38 16 36470 1963 42582886
Tricuspid valve incompetence 21.43 11.38 36 36450 11077 42573772
Haemorrhagic fever 21.06 11.38 5 36481 27 42584822
Hepatic enzyme increased 20.81 11.38 86 36400 45698 42539151
Blood triglycerides abnormal 20.73 11.38 8 36478 257 42584592
Death 20.27 11.38 283 36203 470902 42113947
Testicular oedema 19.89 11.38 6 36480 89 42584760
Anticoagulation drug level above therapeutic 19.85 11.38 17 36469 2573 42582276
Asthenia 19.47 11.38 343 36143 280450 42304399
Dyspnoea at rest 19.46 11.38 21 36465 4228 42580621
Myocardial infarction 19.20 11.38 176 36310 123833 42461016
Necrotising myositis 19.08 11.38 12 36474 1129 42583720
Respiratory failure 18.92 11.38 52 36434 128080 42456769
Renal failure 18.84 11.38 197 36289 143529 42441320
Diabetic ketoacidosis 18.12 11.38 51 36435 22316 42562533
Post procedural fistula 17.86 11.38 6 36480 128 42584721
Blood glucose increased 17.78 11.38 116 36370 73583 42511266
Necrotising panniculitis 17.70 11.38 5 36481 58 42584791
Muscle spasms 17.56 11.38 130 36356 85914 42498935
Skin lesion 17.36 11.38 57 36429 27117 42557732
Viral rash 16.67 11.38 6 36480 158 42584691
Myelosuppression 16.45 11.38 7 36479 40454 42544395
Ketonuria 16.43 11.38 9 36477 655 42584194
Abdominal pain upper 16.39 11.38 124 36362 82485 42502364
Product dose omission issue 16.36 11.38 203 36283 154162 42430687
Meningitis streptococcal 16.28 11.38 5 36481 79 42584770
Product use in unapproved indication 16.27 11.38 92 36394 184364 42400485
Thrombocytopenia 16.19 11.38 96 36390 190183 42394666
Impatience 16.10 11.38 8 36478 476 42584373
Myopathy 16.00 11.38 36 36450 13725 42571124
Treatment failure 15.98 11.38 18 36468 62606 42522243
Intestinal obstruction 15.62 11.38 55 36431 27103 42557746
Intraocular pressure decreased 15.57 11.38 5 36481 92 42584757
Hepatitis 15.46 11.38 55 36431 27245 42557604
Food craving 15.40 11.38 8 36478 523 42584326
Starvation 15.33 11.38 8 36478 528 42584321
Papillary renal cell carcinoma 15.24 11.38 7 36479 349 42584500
Acute coronary syndrome 15.23 11.38 37 36449 14828 42570021
Retinal vein occlusion 15.18 11.38 13 36473 1968 42582881
Diet noncompliance 15.04 11.38 6 36480 211 42584638
Cholelithiasis 14.94 11.38 49 36437 23297 42561552
Haematochezia 14.69 11.38 17 36469 58419 42526430
Hyperlipidaemia 14.53 11.38 46 36440 21470 42563379
Drug ineffective 14.53 11.38 420 36066 629777 41955072
Blood creatinine increased 14.51 11.38 151 36335 109852 42474997
Ventricular fibrillation 14.34 11.38 4 36482 30119 42554730
Fanconi syndrome 14.21 11.38 12 36474 1782 42583067
Loss of bladder sensation 14.11 11.38 4 36482 47 42584802
Hypercreatinaemia 13.88 11.38 6 36480 259 42584590
Ejection fraction decreased 13.82 11.38 46 36440 22041 42562808
Chondrocalcinosis 13.71 11.38 8 36478 657 42584192
Aortic valve incompetence 13.69 11.38 22 36464 6526 42578323
Drug-disease interaction 13.66 11.38 9 36477 917 42583932
Tendinous contracture 13.64 11.38 5 36481 139 42584710
Diabetic neuropathy 13.60 11.38 18 36468 4484 42580365
Blood cholesterol increased 13.57 11.38 52 36434 26689 42558160
Glutamate dehydrogenase increased 13.18 11.38 3 36483 13 42584836
Respiratory arrest 13.12 11.38 4 36482 28420 42556429
Non-alcoholic steatohepatitis 13.04 11.38 9 36477 990 42583859
Coma acidotic 13 11.38 3 36483 14 42584835
Wheezing 12.66 11.38 17 36469 54764 42530085
Glycosuria 12.61 11.38 10 36476 1360 42583489
Optic neuropathy 12.54 11.38 13 36473 2499 42582350
Periarthritis 12.54 11.38 10 36476 1370 42583479
Pericardial effusion 12.53 11.38 54 36432 29221 42555628
Cytomegalovirus infection 12.49 11.38 6 36480 32300 42552549
Medulloblastoma 12.39 11.38 4 36482 75 42584774
Diabetic wound 12.29 11.38 4 36482 77 42584772
Slow speech 12.22 11.38 11 36475 1779 42583070
Hepatitis acute 12.18 11.38 25 36461 8950 42575899
Liver injury 12.08 11.38 40 36446 19108 42565741
Fall 12.05 11.38 274 36212 234246 42350603
Leukopenia 12.05 11.38 29 36457 74717 42510132
Cardiomyopathy 12.01 11.38 40 36446 19170 42565679
Loss of personal independence in daily activities 11.98 11.38 15 36471 49801 42535048
Cutaneous lupus erythematosus 11.94 11.38 8 36478 838 42584011
Hepatic cytolysis 11.86 11.38 50 36436 26794 42558055
Intentional overdose 11.86 11.38 16 36470 51440 42533409
Sleep apnoea syndrome 11.78 11.38 43 36443 21565 42563284
Breast cyst 11.62 11.38 3 36483 24 42584825
Urticaria pigmentosa 11.62 11.38 3 36483 24 42584825
Ventricular hypokinesia 11.58 11.38 21 36465 6863 42577986
Procedural pain 11.52 11.38 19 36467 5760 42579089

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 477.58 10.49 342 62992 59932 110466033
Rhabdomyolysis 331.46 10.49 376 62958 120025 110405940
Acute kidney injury 293.12 10.49 913 62421 634517 109891448
High density lipoprotein decreased 255.29 10.49 103 63231 5630 110520335
Hepatic function abnormal 204.57 10.49 254 63080 89041 110436924
Blood creatine phosphokinase increased 198.94 10.49 227 63107 72850 110453115
Hypertriglyceridaemia 186.69 10.49 116 63218 16038 110509927
Myalgia 183.44 10.49 398 62936 221983 110303982
Blood triglycerides increased 180.82 10.49 132 63202 23794 110502171
Pancreatitis 148.85 10.49 223 63111 93310 110432655
Drug interaction 146.85 10.49 621 62713 499562 110026403
Synovitis 114.28 10.49 12 63322 274080 110251885
Systemic lupus erythematosus 109.02 10.49 10 63324 254328 110271637
Hand deformity 107.48 10.49 4 63330 218502 110307463
Renal failure 98.89 10.49 320 63014 226254 110299711
Pemphigus 98.87 10.49 6 63328 214564 110311401
Glossodynia 97.13 10.49 8 63326 221996 110303969
Pericarditis 85.42 10.49 12 63322 219102 110306863
Pulmonary valve disease 81.01 10.49 22 63312 337 110525628
Pancreatitis necrotising 80.50 10.49 46 63288 5455 110520510
Folliculitis 79.37 10.49 4 63330 167649 110358316
Glycosylated haemoglobin increased 79.33 10.49 82 63252 23537 110502428
Pericardial disease 77.93 10.49 25 63309 698 110525267
Wound 76.28 10.49 20 63314 234417 110291548
Renal impairment 75.84 10.49 259 63075 188186 110337779
Infusion related reaction 72.34 10.49 67 63267 381095 110144870
Off label use 69.67 10.49 539 62795 1499646 109026319
Impaired healing 67.49 10.49 15 63319 196702 110329263
Pancreatitis haemorrhagic 65.86 10.49 24 63310 992 110524973
Fall 65.80 10.49 579 62755 602903 109923062
Rheumatoid arthritis 65.16 10.49 46 63288 299567 110226398
Therapeutic product effect decreased 63.82 10.49 30 63304 244286 110281679
Treatment failure 63.74 10.49 40 63294 277194 110248771
Hepatic steatosis 63.26 10.49 106 63228 48725 110477240
Jaundice 63.07 10.49 118 63216 59118 110466847
Rheumatoid factor positive 62.76 10.49 3 63331 131637 110394328
Arthropathy 62.71 10.49 44 63290 287478 110238487
Wheezing 62.68 10.49 34 63300 255196 110270769
International normalised ratio increased 62.20 10.49 147 63187 86625 110439340
Irritable bowel syndrome 61.69 10.49 10 63324 164205 110361760
Stenosis 59.97 10.49 32 63302 3319 110522646
Physical examination abnormal 59.69 10.49 19 63315 517 110525448
Contraindicated product administered 59.63 10.49 34 63300 248233 110277732
Myopathy 58.73 10.49 72 63262 24888 110501077
Gamma-glutamyltransferase increased 57.79 10.49 116 63218 61193 110464772
Electrocardiogram Q wave abnormal 57.41 10.49 20 63314 724 110525241
Muscle injury 56.57 10.49 7 63327 140800 110385165
Fibromyalgia 54.80 10.49 15 63319 170894 110355071
Hypersensitivity 54.68 10.49 92 63242 403906 110122059
Stomatitis 54.28 10.49 45 63289 270197 110255768
Hepatojugular reflux 53.81 10.49 19 63315 716 110525249
Mitral valve disease 53.79 10.49 30 63304 3395 110522570
Confabulation 52.03 10.49 17 63317 504 110525461
Cardiac discomfort 51.25 10.49 22 63312 1406 110524559
Maternal exposure during pregnancy 50.50 10.49 43 63291 254840 110271125
Joint swelling 49.42 10.49 113 63221 442732 110083233
Acute myocardial infarction 48.62 10.49 131 63203 83646 110442319
Sleep disorder due to general medical condition, insomnia type 48.52 10.49 3 63331 105640 110420325
Alopecia 48.49 10.49 84 63250 364669 110161296
Bursitis 46.43 10.49 9 63325 129909 110396056
Vulvovaginal burning sensation 46.40 10.49 23 63311 2046 110523919
Diabetes mellitus inadequate control 45.93 10.49 70 63264 29705 110496260
Euglycaemic diabetic ketoacidosis 45.77 10.49 44 63290 11579 110514386
Lip dry 45.49 10.49 3 63331 100080 110425885
Infection 44.95 10.49 87 63247 362113 110163852
Coronary artery disease 44.55 10.49 115 63219 71575 110454390
Drug-induced liver injury 43.95 10.49 160 63174 119907 110406058
Echocardiogram abnormal 43.58 10.49 24 63310 2650 110523315
Occult blood 42.72 10.49 21 63313 1835 110524130
Lactic acidosis 42.19 10.49 133 63201 92678 110433287
Photosensitivity reaction 42.10 10.49 62 63272 25527 110500438
Apolipoprotein A-I decreased 41.44 10.49 8 63326 21 110525944
Mobility decreased 41.28 10.49 45 63289 237377 110288588
Myocardial infarction 41.20 10.49 218 63116 191865 110334100
Dyslipidaemia 40.75 10.49 48 63286 15917 110510048
Swelling 40.44 10.49 88 63246 350953 110175012
Drug abuse 40.21 10.49 26 63308 177385 110348580
Diabetic metabolic decompensation 40.12 10.49 26 63308 3863 110522102
Systolic dysfunction 39.48 10.49 27 63307 4388 110521577
Metabolic syndrome 39.25 10.49 24 63310 3223 110522742
Left ventricular dysfunction 38.76 10.49 57 63277 23436 110502529
Vulvovaginal pruritus 38.68 10.49 24 63310 3307 110522658
Glomerular filtration rate decreased 37.69 10.49 63 63271 28893 110497072
Lower respiratory tract infection 37.07 10.49 51 63283 243055 110282910
Hypoglycaemia 36.96 10.49 148 63186 115956 110410009
Nasopharyngitis 36.82 10.49 110 63224 394251 110131714
Pulmonary embolism 36.57 10.49 229 63105 214245 110311720
Carotid artery stenosis 36.35 10.49 35 63299 9228 110516737
Chronic kidney disease 36.22 10.49 111 63223 76180 110449785
Asthenia 35.97 10.49 574 62760 688425 109837540
Wound infection 35.94 10.49 6 63328 96459 110429506
Carotid arteriosclerosis 35.44 10.49 22 63312 3035 110522930
Blood glucose increased 35.30 10.49 160 63174 132336 110393629
Rhinalgia 35.06 10.49 24 63310 3905 110522060
Psoriasis 35.05 10.49 166 63168 139827 110386138
Proteinuria 34.51 10.49 73 63261 39945 110486020
Ventricular arrhythmia 33.84 10.49 35 63299 10052 110515913
Discomfort 33.79 10.49 44 63290 214663 110311302
Fibrillary glomerulonephritis 33.55 10.49 8 63326 70 110525895
Libido disorder 33.51 10.49 11 63323 331 110525634
Blister 33.38 10.49 49 63285 227327 110298638
Hepatorenal failure 33.14 10.49 16 63318 1344 110524621
Rectosigmoid cancer 33.07 10.49 11 63323 345 110525620
Blood creatinine increased 32.89 10.49 198 63136 182691 110343274
Abdominal discomfort 32.52 10.49 116 63218 393742 110132223
Grip strength decreased 32.17 10.49 4 63330 80170 110445795
Asthma 32.02 10.49 59 63275 250232 110275733
Needle track marks 31.98 10.49 8 63326 87 110525878
Peripheral venous disease 31.86 10.49 5 63329 84112 110441853
Pancreatic neoplasm 31.43 10.49 17 63317 1812 110524153
Pancreatitis relapsing 31.33 10.49 16 63318 1516 110524449
Myoglobin blood increased 31.18 10.49 23 63311 4209 110521756
Left ventricular hypertrophy 30.83 10.49 38 63296 13206 110512759
Helicobacter gastritis 30.76 10.49 19 63315 2597 110523368
Product use issue 30.51 10.49 85 63249 311610 110214355
Joint range of motion decreased 30.23 10.49 16 63318 121816 110404149
Orbital compartment syndrome 30.19 10.49 8 63326 111 110525854
Mitral valve incompetence 30.15 10.49 62 63272 33267 110492698
Inflammation 30 10.49 40 63294 193198 110332767
Diabetic ketoacidosis 29.86 10.49 71 63263 41987 110483978
Amaurosis fugax 29.75 10.49 18 63316 2372 110523593
Anaemia macrocytic 29.42 10.49 28 63306 7275 110518690
Medulloblastoma 29.31 10.49 8 63326 125 110525840
Musculoskeletal stiffness 29.13 10.49 74 63260 279748 110246217
Blood cholesterol abnormal 29.05 10.49 21 63313 3725 110522240
Gastrointestinal haemorrhage 29.01 10.49 178 63156 165340 110360625
Hepatic failure 28.97 10.49 96 63238 68643 110457322
Lichenoid keratosis 28.95 10.49 26 63308 6276 110519689
Cholestasis 28.90 10.49 92 63242 64426 110461539
Lymphopenia 28.72 10.49 68 63266 40102 110485863
Paranasal sinus discomfort 28.59 10.49 26 63308 6379 110519586
Psoriatic arthropathy 28.30 10.49 43 63291 196718 110329247
Lichen nitidus 28.25 10.49 8 63326 144 110525821
Product use in unapproved indication 28.20 10.49 146 63188 447231 110078734
Total cholesterol/HDL ratio abnormal 27.83 10.49 7 63327 78 110525887
Glycogen storage disease type V 27.58 10.49 6 63328 33 110525932
Hyperglycaemia 27.51 10.49 109 63225 84981 110440984
Hepatitis acute 27.38 10.49 43 63291 18723 110507242
Injury 27.21 10.49 37 63297 177228 110348737
Drug intolerance 27.14 10.49 130 63204 406382 110119583
Diastolic dysfunction 26.35 10.49 34 63300 12370 110513595
Urticaria 26.25 10.49 94 63240 318763 110207202
Hepatic cytolysis 26.04 10.49 80 63254 54973 110470992
Subacute kidney injury 25.66 10.49 5 63329 14 110525951
Erectile dysfunction 24.99 10.49 41 63293 18515 110507450
Nephrosclerosis 24.59 10.49 15 63319 2006 110523959
Drug ineffective 24.44 10.49 674 62660 1519866 109006099
Live birth 24.43 10.49 5 63329 69479 110456486
Hyporesponsive to stimuli 24.42 10.49 17 63317 2843 110523122
Product dose omission issue 24.07 10.49 286 63048 321496 110204469
Low density lipoprotein increased 23.86 10.49 30 63304 10636 110515329
Hyperlipidaemia 23.83 10.49 59 63275 35789 110490176
Bundle branch block left 23.81 10.49 33 63301 12855 110513110
Haemorrhagic stroke 23.54 10.49 34 63300 13755 110512210
Myotonia 23.50 10.49 8 63326 270 110525695
Hepatocellular injury 23.40 10.49 73 63261 50569 110475396
Intentional product use issue 23.23 10.49 69 63265 247837 110278128
Testicular oedema 23.01 10.49 6 63328 78 110525887
Night sweats 22.61 10.49 26 63308 133957 110392008
Skin weeping 22.48 10.49 18 63316 3717 110522248
Mucosal dryness 22.43 10.49 19 63315 4244 110521721
General physical health deterioration 22.41 10.49 147 63187 425148 110100817
Ectopic gastric mucosa 22.21 10.49 5 63329 33 110525932
Acute coronary syndrome 22.10 10.49 44 63290 23068 110502897
Injection site extravasation 21.80 10.49 28 63306 10141 110515824
Skin lesion 21.66 10.49 72 63262 51559 110474406
Arachnoiditis 21.63 10.49 11 63323 1033 110524932
Supraventricular tachycardia 21.58 10.49 45 63289 24377 110501588
Increased appetite 21.41 10.49 34 63300 14943 110511022
Multiple fractures 21.37 10.49 26 63308 8914 110517051
Nasal dryness 21.34 10.49 21 63313 5685 110520280
Rales 21.18 10.49 45 63289 24694 110501271
Dilatation ventricular 21.11 10.49 18 63316 4057 110521908
Blood triglycerides abnormal 20.89 10.49 9 63325 580 110525385
Blood glucose abnormal 20.82 10.49 31 63303 12885 110513080
Distributive shock 20.74 10.49 21 63313 5883 110520082
Alkalosis hypochloraemic 20.72 10.49 9 63325 592 110525373
Apolipoprotein B increased 20.58 10.49 4 63330 11 110525954
Cholelithiasis 20.30 10.49 81 63253 63341 110462624
Nephropathy toxic 20.17 10.49 47 63287 27431 110498534
Aortic valve incompetence 20.11 10.49 28 63306 10953 110515012
Lower limb fracture 20.05 10.49 9 63325 75339 110450626
Tricuspid valve incompetence 19.95 10.49 43 63291 23830 110502135
Metabolic acidosis 19.89 10.49 111 63223 99633 110426332
Ureteric injury 19.85 10.49 6 63328 137 110525828
Change of bowel habit 19.82 10.49 15 63319 2854 110523111
Therapeutic product effect incomplete 19.76 10.49 64 63270 223741 110302224
Narcotic bowel syndrome 19.62 10.49 7 63327 272 110525693
Hepatic enzyme increased 19.49 10.49 106 63228 320786 110205179
Type 2 diabetes mellitus 19.12 10.49 46 63288 177186 110348779
Arterial spasm 18.72 10.49 6 63328 167 110525798
Glycosuria 18.72 10.49 14 63320 2616 110523349
Angiopathy 18.65 10.49 24 63310 8706 110517259
Gait inability 18.48 10.49 31 63303 136345 110389620
Necrotising panniculitis 18.39 10.49 5 63329 77 110525888
Pericardial effusion 18.25 10.49 73 63261 57144 110468821
Nasal discomfort 18.18 10.49 20 63314 6161 110519804
Dehydration 18.15 10.49 242 63092 279269 110246696
Diarrhoea 17.82 10.49 810 62524 1138695 109387270
Medulloblastoma recurrent 17.81 10.49 6 63328 196 110525769
Pseudohallucination 17.44 10.49 6 63328 209 110525756
Sleep disorder 17.40 10.49 57 63277 198587 110327378
Upper-airway cough syndrome 17.39 10.49 32 63302 15825 110510140
Necrotising myositis 17.33 10.49 12 63322 1990 110523975
Pregnancy 17.29 10.49 4 63330 51063 110474902
Aspartate aminotransferase increased 17.12 10.49 153 63181 159783 110366182
Non-alcoholic steatohepatitis 16.99 10.49 13 63321 2514 110523451
Eosinophilia 16.97 10.49 72 63262 57864 110468101
Obstructive airways disorder 16.91 10.49 3 63331 46146 110479819
Thirst 16.90 10.49 38 63296 21669 110504296
Haemorrhagic fever 16.88 10.49 4 63330 34 110525931
Hypokinetic dysarthria 16.88 10.49 4 63330 34 110525931
Blood triglycerides decreased 16.87 10.49 6 63328 231 110525734
Ocular icterus 16.79 10.49 19 63315 6034 110519931
Nephrotic syndrome 16.56 10.49 29 63305 13802 110512163
Post procedural fistula 16.49 10.49 7 63327 435 110525530
Polymyositis 16.45 10.49 15 63319 3693 110522272
Chromaturia 16.12 10.49 45 63289 29315 110496650
Kidney fibrosis 16.12 10.49 16 63318 4376 110521589
Cardiac failure 15.93 10.49 171 63163 187455 110338510
Hepatitis fulminant 15.93 10.49 22 63312 8538 110517427
Ill-defined disorder 15.92 10.49 42 63292 156811 110369154
Migraine 15.92 10.49 48 63286 171604 110354361
Hyperthermia malignant 15.80 10.49 15 63319 3885 110522080
Gastrointestinal disorder 15.77 10.49 78 63256 241874 110284091
Orthopnoea 15.73 10.49 25 63309 10996 110514969
Adrenal adenoma 15.45 10.49 10 63324 1482 110524483
Hepatic fibrosis 15.42 10.49 21 63313 8045 110517920
Anticoagulation drug level above therapeutic 15.41 10.49 16 63318 4614 110521351
Nail disorder 15.29 10.49 7 63327 57928 110468037
Liver function test increased 15.14 10.49 17 63317 88531 110437434
Sinusitis 14.89 10.49 104 63230 296584 110229381
Dyspnoea at rest 14.87 10.49 21 63313 8325 110517640
Phospholipidosis 14.83 10.49 6 63328 330 110525635
Intestinal obstruction 14.71 10.49 65 63269 53162 110472803
Hyperkalaemia 14.58 10.49 130 63204 135666 110390299
Agranulocytosis 14.56 10.49 72 63262 61688 110464277
Ketoacidosis 14.56 10.49 23 63311 10064 110515901
Vascular access site pain 14.50 10.49 7 63327 588 110525377
Hypoaesthesia 14.41 10.49 113 63221 314110 110211855
Subacute cutaneous lupus erythematosus 14.41 10.49 16 63318 4978 110520987
Diet noncompliance 14.38 10.49 7 63327 599 110525366
Cardiomyopathy 14.28 10.49 47 63287 33478 110492487
Intraocular pressure decreased 14.22 10.49 5 63329 186 110525779
Diabetic wound 14.08 10.49 4 63330 73 110525892
Pulmonary fibrosis 14.00 10.49 23 63311 102019 110423946
Urinary tract disorder 13.98 10.49 17 63317 5827 110520138
Pain 13.85 10.49 429 62905 954526 109571439
Congestive hepatopathy 13.83 10.49 16 63318 5204 110520761
Urinary tract infection 13.80 10.49 263 63071 326019 110199946
Cholestatic liver injury 13.79 10.49 19 63315 7357 110518608
Electrocardiogram abnormal 13.73 10.49 32 63302 18677 110507288
Cytomegalovirus infection 13.73 10.49 7 63327 54437 110471528
Hypertonic bladder 13.63 10.49 16 63318 5286 110520679
Transaminases increased 13.62 10.49 72 63262 63318 110462647
Alanine aminotransferase increased 13.58 10.49 163 63171 183610 110342355
Hypercreatinaemia 13.54 10.49 6 63328 414 110525551
Chronic cutaneous lupus erythematosus 13.53 10.49 8 63326 1011 110524954
Starvation 13.50 10.49 8 63326 1015 110524950
Hepatic necrosis 13.47 10.49 22 63312 9900 110516065
Intra-abdominal haematoma 13.40 10.49 13 63321 3459 110522506
Ketonuria 13.36 10.49 9 63325 1426 110524539
Therapy cessation 13.34 10.49 56 63278 44801 110481164
Meningitis streptococcal 13.23 10.49 5 63329 229 110525736
Therapy non-responder 13.19 10.49 46 63288 157261 110368704
Drug hypersensitivity 13.15 10.49 182 63152 453908 110072057
Haematuria 13.13 10.49 87 63247 82918 110443047
Ocular discomfort 13.07 10.49 20 63314 8513 110517452
Hypovolaemic shock 13.04 10.49 27 63307 14556 110511409
Xanthoma 13.03 10.49 5 63329 239 110525726
Atypical teratoid/rhabdoid tumour of CNS 12.93 10.49 3 63331 23 110525942
Loss of bladder sensation 12.93 10.49 4 63330 99 110525866
Ejection fraction decreased 12.91 10.49 52 63282 40828 110485137
Vasoconstriction 12.90 10.49 8 63326 1102 110524863
Hip arthroplasty 12.89 10.49 8 63326 55805 110470160
Onychomadesis 12.88 10.49 5 63329 45658 110480307
Adverse event 12.74 10.49 27 63307 108782 110417183
Macule 12.66 10.49 13 63321 3700 110522265
Urticaria pigmentosa 12.61 10.49 3 63331 26 110525939
Viral rash 12.43 10.49 6 63328 504 110525461
Amyotrophic lateral sclerosis 12.42 10.49 10 63324 2081 110523884
Drug reaction with eosinophilia and systemic symptoms 12.36 10.49 85 63249 82010 110443955
Blood loss anaemia 12.33 10.49 30 63304 17995 110507970
Intentional overdose 12.32 10.49 37 63297 132464 110393501
Road traffic accident 12.29 10.49 27 63307 107371 110418594
Aphthous ulcer 12.21 10.49 33 63301 21103 110504862
Ureteric cancer recurrent 12.13 10.49 3 63331 31 110525934
Colitis ulcerative 12.02 10.49 16 63318 77347 110448618
Radicular pain 11.97 10.49 6 63328 547 110525418
Coronary artery bypass 11.96 10.49 16 63318 6026 110519939
Hyponatraemia 11.95 10.49 183 63151 217470 110308495
Renin decreased 11.92 10.49 4 63330 129 110525836
Aortic arteriosclerosis 11.90 10.49 22 63312 10916 110515049
Blood potassium increased 11.90 10.49 44 63290 33205 110492760
Steatohepatitis 11.83 10.49 8 63326 1277 110524688
Muscle spasticity 11.80 10.49 3 63331 35912 110490053
Cardiomegaly 11.67 10.49 40 63294 29090 110496875
Splenic thrombosis 11.66 10.49 4 63330 138 110525827
Lipase increased 11.64 10.49 30 63304 18642 110507323
Sciatica 11.62 10.49 22 63312 92377 110433588
Paraesthesia 11.52 10.49 102 63232 276419 110249546
Antiangiogenic therapy 11.50 10.49 3 63331 39 110525926
Exposure during pregnancy 11.48 10.49 53 63281 167371 110358594
Starvation ketoacidosis 11.45 10.49 5 63329 333 110525632
Exostosis 11.45 10.49 6 63328 45950 110480015
Fanconi syndrome 11.43 10.49 12 63322 3507 110522458
Violence-related symptom 11.37 10.49 7 63327 952 110525013
Hypomagnesaemia 11.26 10.49 66 63268 60304 110465661
Toxic skin eruption 11.21 10.49 38 63296 27477 110498488
Delusional disorder, persecutory type 11.19 10.49 6 63328 628 110525337
Catheter site thrombosis 11.19 10.49 6 63328 628 110525337
Thyroid stimulating hormone deficiency 11.04 10.49 3 63331 46 110525919
Papillary renal cell carcinoma 11.03 10.49 5 63329 364 110525601
Obesity 11.01 10.49 31 63303 113320 110412645
Urea cycle disorder 10.98 10.49 3 63331 47 110525918
Nephropathy 10.96 10.49 24 63310 13443 110512522
Drug-disease interaction 10.96 10.49 9 63325 1927 110524038
Acidosis 10.89 10.49 33 63301 22498 110503467
Dermatomyositis 10.84 10.49 13 63321 4393 110521572
Chondrocalcinosis 10.76 10.49 9 63325 1976 110523989
Lipids abnormal 10.76 10.49 6 63328 679 110525286
Epileptic encephalopathy 10.76 10.49 6 63328 679 110525286
Renal phospholipidosis 10.67 10.49 5 63329 393 110525572
Toxic shock syndrome 10.62 10.49 8 63326 1512 110524453
Photocoagulation 10.60 10.49 3 63331 54 110525911

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
ATC C10BA14 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA15 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
ATC C10BA16 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, COMBINATIONS
Combinations of various lipid modifying agents
FDA CS M0543661 Fibric Acids
FDA MoA N0000175375 Peroxisome Proliferator-activated Receptor alpha Agonists
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D057847 Lipid Regulating Agents
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35679 antilipemic drug
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:145947 antiatherosclerotic agent
CHEBI has role CHEBI:176497 geroprotector
FDA EPC N0000175596 Peroxisome Proliferator Receptor alpha Agonist

Related Drugs by ATC class:

C10AB Fibrates 11 drugs
aluminium clofibratebezafibratecholine fenofibrateciprofibrateclofibrateclofibrideetofibrategemfibrozilpemafibrateronifibratesimfibrate
C10BA Combinations of various lipid modifying agents 9 drugs
atorvastatinbempedoic acidezetimibelovastatinnicotinic acidpitavastatinpravastatinrosuvastatinsimvastatin

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
90MG **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 9314447 May 31, 2033 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG **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 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 Cytosolic other 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
J3O PDB_CHEM_ID
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
U202363UOS INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0115-0533 CAPSULE 200 mg ORAL ANDA 12 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 0378-3065 TABLET, FILM COATED 48 mg ORAL ANDA 27 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0378-3066 TABLET, FILM COATED 145 mg ORAL ANDA 27 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 0615-8270 TABLET 160 mg ORAL ANDA 26 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0615-8530 TABLET 145 mg ORAL ANDA 25 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7161 TABLET 145 mg ORAL ANDA 24 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 0904-7480 TABLET 145 mg ORAL ANDA 25 sections
FENOFIBRATE HUMAN PRESCRIPTION DRUG LABEL 1 0904-7539 TABLET 160 mg ORAL ANDA 26 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 13668-438 CAPSULE 200 mg ORAL ANDA 14 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 13668-439 CAPSULE 134 mg ORAL ANDA 14 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 13668-440 CAPSULE 67 mg ORAL ANDA 14 sections
fenofibrate Human Prescription Drug Label 1 27241-116 TABLET 54 mg ORAL ANDA 25 sections
fenofibrate Human Prescription Drug Label 1 27241-117 TABLET 160 mg ORAL ANDA 25 sections
Fenofibrate Human Prescription Drug Label 1 27241-118 CAPSULE 67 mg ORAL ANDA 13 sections
Fenofibrate Human Prescription Drug Label 1 27241-118 CAPSULE 67 mg ORAL ANDA 13 sections
Fenofibrate Human Prescription Drug Label 1 27241-119 CAPSULE 134 mg ORAL ANDA 13 sections
Fenofibrate Human Prescription Drug Label 1 27241-119 CAPSULE 134 mg ORAL ANDA 13 sections
Fenofibrate Human Prescription Drug Label 1 27241-120 CAPSULE 200 mg ORAL ANDA 13 sections
Fenofibrate Human Prescription Drug Label 1 27241-120 CAPSULE 200 mg ORAL ANDA 13 sections
Antara HUMAN PRESCRIPTION DRUG LABEL 1 27437-107 CAPSULE 30 mg ORAL NDA 25 sections
Antara HUMAN PRESCRIPTION DRUG LABEL 1 27437-108 CAPSULE 90 mg ORAL NDA 25 sections
ANTARA HUMAN PRESCRIPTION DRUG LABEL 1 27437-109 CAPSULE 43 mg ORAL NDA 25 sections
ANTARA HUMAN PRESCRIPTION DRUG LABEL 1 27437-110 CAPSULE 130 mg ORAL NDA 25 sections
Fenofibrate HUMAN PRESCRIPTION DRUG LABEL 1 31722-595 TABLET, FILM COATED 48 mg ORAL ANDA 26 sections