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

Stem definition	Drug id	CAS RN
clofibrate derivatives, peroxisome proliferator activated receptor-alpha(PPAR-alpha) agonists	1152	49562-28-9

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.20	g	O

ADMET properties:

Property	Value	Reference
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:

Date	Agency	Company	Orphan
Dec. 31, 1993	FDA	ABBVIE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Rhabdomyolysis	227.87	10.91	200	34822	38827	50531275
Pancreatitis acute	165.61	10.91	135	34887	23677	50546425
Blood triglycerides increased	160.14	10.91	99	34923	11213	50558889
Pancreatitis	150.59	10.91	166	34856	42448	50527654
Acute kidney injury	147.92	10.91	418	34604	227640	50342462
Myalgia	110.69	10.91	257	34765	124062	50446040
High density lipoprotein decreased	84.94	10.91	35	34987	1665	50568437
Blood creatine phosphokinase increased	80.07	10.91	95	34927	26272	50543830
International normalised ratio increased	74.11	10.91	118	34904	43034	50527068
Drug ineffective	73.27	10.91	306	34716	819027	49751075
Contraindicated product administered	69.88	10.91	10	35012	148948	50421154
Renal failure	67.51	10.91	194	34828	106439	50463663
Pemphigus	64.19	10.91	5	35017	120161	50449941
Hypertriglyceridaemia	60.34	10.91	41	34981	5450	50564652
Treatment failure	58.49	10.91	12	35010	137625	50432477
Systemic lupus erythematosus	58.25	10.91	13	35009	140609	50429493
Maternal exposure during pregnancy	58.23	10.91	19	35003	159759	50410343
Hand deformity	56.99	10.91	3	35019	100196	50469906
Glossodynia	56.01	10.91	7	35015	115562	50454540
Infusion related reaction	53.81	10.91	25	34997	169532	50400570
Confabulation	49.61	10.91	15	35007	281	50569821
Joint swelling	47.53	10.91	60	34962	245226	50324876
Drug interaction	46.00	10.91	265	34757	199356	50370746
Skin weeping	44.31	10.91	15	35007	409	50569693
Rheumatoid arthritis	44.18	10.91	45	34977	202505	50367597
Myocardial infarction	40.81	10.91	145	34877	88882	50481220
Blood glucose increased	40.59	10.91	125	34897	71199	50498903
Pericarditis	40.05	10.91	4	35018	78685	50491417
Rectosigmoid cancer	39.70	10.91	11	35011	149	50569953
Wound	39.57	10.91	12	35010	105782	50464320
Hepatorenal failure	39.15	10.91	15	35007	588	50569514
Therapeutic product effect decreased	38.81	10.91	23	34999	136027	50434075
Coronary artery disease	38.81	10.91	72	34950	29654	50540448
Hepatic function abnormal	38.77	10.91	76	34946	32605	50537497
Myoglobin blood increased	36.93	10.91	18	35004	1275	50568827
Off label use	36.92	10.91	186	34836	474240	50095862
Nephrosclerosis	36.09	10.91	16	35006	912	50569190
Lichenoid keratosis	35.91	10.91	18	35004	1354	50568748
Jaundice	35.74	10.91	65	34957	26364	50543738
Hypertonic bladder	34.40	10.91	23	34999	2977	50567125
Hepatic steatosis	34.29	10.91	61	34961	24323	50545779
Abdominal discomfort	32.42	10.91	70	34952	231571	50338531
Arthropathy	32.29	10.91	37	34985	157869	50412233
Swelling	32.20	10.91	56	34966	200816	50369286
Hyperglycaemia	32.04	10.91	75	34947	36330	50533772
Lichen nitidus	31.84	10.91	8	35014	72	50570030
Alkalosis hypochloraemic	31.69	10.91	9	35013	134	50569968
Psoriasis	31.29	10.91	112	34910	68888	50501214
Photosensitivity reaction	30.42	10.91	41	34981	12870	50557232
Alopecia	30.36	10.91	79	34943	244968	50325134
Glycosylated haemoglobin increased	30.20	10.91	37	34985	10569	50559533
Cholestasis	30.04	10.91	59	34963	25342	50544760
Apolipoprotein A-I decreased	28.88	10.91	6	35016	20	50570082
Product use issue	28.47	10.91	37	34985	149438	50420664
Fall	28.34	10.91	355	34667	334577	50235525
Kidney fibrosis	27.94	10.91	16	35006	1573	50568529
Infection	27.91	10.91	48	34974	172906	50397196
Myopathy	27.85	10.91	33	34989	9106	50560996
Lower respiratory tract infection	27.28	10.91	16	35006	95185	50474917
Chronic cutaneous lupus erythematosus	27.18	10.91	8	35014	136	50569966
Diabetes mellitus	27.02	10.91	85	34937	48948	50521154
Change of bowel habit	26.23	10.91	16	35006	1768	50568334
Multiple fractures	25.51	10.91	27	34995	6584	50563518
Dilatation ventricular	24.69	10.91	17	35005	2308	50567794
Congestive hepatopathy	23.62	10.91	17	35005	2477	50567625
Narcotic bowel syndrome	23.57	10.91	7	35015	123	50569979
Arterial spasm	23.41	10.91	6	35016	59	50570043
Myotonia	22.72	10.91	7	35015	140	50569962
Ocular icterus	22.68	10.91	19	35003	3456	50566646
Diabetes mellitus inadequate control	22.63	10.91	36	34986	13109	50556993
Hypoglycaemia	22.63	10.91	85	34937	53496	50516606
Dyslipidaemia	22.30	10.91	24	34998	5964	50564138
Blood creatinine increased	22.23	10.91	108	34914	76052	50494050
Cholelithiasis	22.01	10.91	67	34955	37906	50532196
Drug abuse	21.99	10.91	7	35015	59839	50510263
Mucosal dryness	21.81	10.91	16	35006	2401	50567701
Hepatic necrosis	21.27	10.91	22	35000	5226	50564876
Pulmonary embolism	20.82	10.91	131	34891	101573	50468529
Hypersensitivity	20.54	10.91	78	34944	215083	50355019
Lactic acidosis	20.42	10.91	60	34962	33295	50536807
Hepatic fibrosis	19.86	10.91	17	35005	3185	50566917
Orthopnoea	19.80	10.91	22	35000	5667	50564435
Normochromic normocytic anaemia	19.79	10.91	19	35003	4127	50565975
Ophthalmoplegia	19.65	10.91	12	35010	1328	50568774
Stomatitis	19.38	10.91	25	34997	101319	50468783
Exposure during pregnancy	19.14	10.91	34	34988	120981	50449121
Aortic arteriosclerosis	19.05	10.91	21	35001	5361	50564741
Catheter site thrombosis	18.49	10.91	6	35016	143	50569959
Grandiosity	18.14	10.91	7	35015	280	50569822
Product residue present	17.85	10.91	17	35005	3655	50566447
Asthenia	17.85	10.91	315	34707	318727	50251375
Discomfort	17.54	10.91	30	34992	108350	50461752
Mitral valve disease	17.13	10.91	13	35009	2053	50568049
Renal impairment	17.09	10.91	100	34922	75561	50494541
Low density lipoprotein increased	16.57	10.91	20	35002	5626	50564476
Hyperlipidaemia	16.46	10.91	37	34985	17453	50552649
Musculoskeletal stiffness	16.21	10.91	41	34981	128440	50441662
Diabetic metabolic decompensation	16.14	10.91	11	35011	1469	50568633
Gastrointestinal haemorrhage	15.98	10.91	96	34926	73225	50496877
Intra-abdominal haematoma	15.63	10.91	11	35011	1546	50568556
Death	15.58	10.91	147	34875	325232	50244870
Essential hypertension	15.14	10.91	17	35005	4427	50565675
Chromaturia	15.02	10.91	32	34990	14558	50555544
Abnormal loss of weight	14.96	10.91	18	35004	5046	50565056
Xanthoma	14.88	10.91	4	35018	48	50570054
Nicotinic acid deficiency	14.73	10.91	4	35018	50	50570052
Impaired healing	14.64	10.91	16	35006	69770	50500332
Haematoma muscle	14.62	10.91	8	35014	720	50569382
Hyperkalaemia	14.61	10.91	69	34953	48020	50522082
Blood triglycerides abnormal	14.59	10.91	6	35016	284	50569818
Wheezing	14.42	10.91	13	35009	62034	50508068
Hepatocellular injury	14.31	10.91	45	34977	25902	50544200
Colorectal cancer	14.27	10.91	10	35012	1397	50568705
Irritable bowel syndrome	14.23	10.91	9	35013	51432	50518670
Alanine aminotransferase	13.94	10.91	4	35018	62	50570040
Malignant neoplasm progression	13.87	10.91	16	35006	68108	50501994
Blood triglycerides decreased	13.82	10.91	4	35018	64	50570038
Somnolence	13.81	10.91	166	34856	154819	50415283
Muscle spasms	13.71	10.91	140	34882	125413	50444689
Gastrointestinal disorder	13.65	10.91	28	34994	94428	50475674
Coronary artery occlusion	13.54	10.91	21	35001	7482	50562620
Metabolic acidosis	13.51	10.91	58	34964	38767	50531335
Aspartate aminotransferase	13.43	10.91	4	35018	71	50570031
Ill-defined disorder	13.25	10.91	11	35011	54643	50515459
Muscle contracture	13.23	10.91	9	35013	1198	50568904
Polymyositis	13.23	10.91	10	35012	1570	50568532
Blood urea increased	13.09	10.91	41	34981	23544	50546558
Mobility decreased	13.06	10.91	22	35000	79926	50490176
Cardiac failure congestive	12.76	10.91	101	34921	84281	50485821
Coagulation test abnormal	12.41	10.91	7	35015	669	50569433
Livedo reticularis	12.40	10.91	11	35011	2161	50567941
Product use in unapproved indication	12.37	10.91	40	34982	115779	50454323
Blood glucose decreased	12.35	10.91	34	34988	18177	50551925
Oedema peripheral	12.29	10.91	165	34857	157796	50412306
Renin decreased	12.26	10.91	4	35018	97	50570005
Auditory disorder	12.08	10.91	6	35016	443	50569659
Taste disorder	11.93	10.91	21	35001	8303	50561799
Dehydration	11.76	10.91	159	34863	152290	50417812
Depression	11.74	10.91	170	34852	165253	50404849
Thirst	11.71	10.91	24	34998	10626	50559476
Vitamin B12 deficiency	11.70	10.91	14	35008	3902	50566200
Lipids increased	11.63	10.91	8	35014	1084	50569018
Cholecystitis acute	11.60	10.91	19	35003	7087	50563015
Medulloblastoma	11.40	10.91	3	35019	33	50570069
Cholecystitis infective	11.30	10.91	9	35013	1525	50568577
Peripheral swelling	11.19	10.91	90	34932	205846	50364256
Macule	11.16	10.91	9	35013	1553	50568549
Nasopharyngitis	11.10	10.91	83	34939	192844	50377258
Pain	10.99	10.91	311	34711	578592	49991510

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pancreatitis acute	244.58	10.85	216	35455	24169	29514687
High density lipoprotein decreased	168.82	10.85	79	35592	2900	29535956
Pancreatitis	140.40	10.85	190	35481	34324	29504532
Blood triglycerides increased	115.46	10.85	107	35564	12727	29526129
Blood creatine phosphokinase increased	88.15	10.85	168	35503	40476	29498380
Myalgia	85.94	10.85	239	35432	73780	29465076
Myocardial infarction	85.73	10.85	310	35361	109986	29428870
Coronary artery disease	83.01	10.85	172	35499	44018	29494838
Hypertriglyceridaemia	70.49	10.85	64	35607	7411	29531445
Rhabdomyolysis	64.39	10.85	190	35481	60618	29478238
Drug abuse	63.80	10.85	10	35661	79873	29458983
Off label use	55.02	10.85	183	35488	300617	29238239
Toxicity to various agents	52.70	10.85	80	35591	173581	29365275
Pericardial disease	48.44	10.85	18	35653	364	29538492
Stenosis	45.14	10.85	23	35648	1018	29537838
Pulmonary valve disease	45.10	10.85	16	35655	282	29538574
Drug-induced liver injury	42.65	10.85	86	35585	21569	29517287
Death	41.36	10.85	243	35428	341841	29197015
Hepatic steatosis	35.15	10.85	64	35607	14882	29523974
Glycogen storage disease type V	32.18	10.85	8	35663	36	29538820
Physical examination abnormal	31.40	10.85	12	35659	263	29538593
Blood glucose increased	30.91	10.85	147	35524	58837	29480019
Fibrillary glomerulonephritis	30.70	10.85	8	35663	45	29538811
Renal failure	29.49	10.85	244	35427	118355	29420501
Cholelithiasis	28.60	10.85	67	35604	18605	29520251
Diabetic metabolic decompensation	28.49	10.85	19	35652	1397	29537459
Hyperlipidaemia	28.45	10.85	53	35618	12537	29526319
Cardiac discomfort	28.13	10.85	13	35658	463	29538393
Acute kidney injury	27.61	10.85	461	35210	264806	29274050
Myopathy	27.21	10.85	47	35624	10486	29528370
Pancreatic neoplasm	26.42	10.85	15	35656	826	29538030
Pancreatitis necrotising	25.95	10.85	22	35649	2325	29536531
Ischaemic cardiomyopathy	25.94	10.85	33	35638	5605	29533251
Rales	25.56	10.85	38	35633	7472	29531384
Blood cholesterol increased	25.03	10.85	57	35614	15538	29523318
Psoriasis	24.47	10.85	90	35581	32137	29506719
Intentional overdose	24.42	10.85	8	35663	38520	29500336
Blood triglycerides abnormal	24.13	10.85	9	35662	184	29538672
Echocardiogram abnormal	23.31	10.85	14	35657	857	29537999
Ectopic gastric mucosa	23.13	10.85	5	35666	10	29538846
Subacute kidney injury	22.89	10.85	4	35667	0	29538856
Ventricular arrhythmia	22.86	10.85	28	35643	4576	29534280
Glycosylated haemoglobin increased	21.70	10.85	40	35631	9386	29529470
Chest pain	21.53	10.85	218	35453	111755	29427101
Mitral valve disease	21.41	10.85	15	35656	1195	29537661
Left ventricular dysfunction	20.78	10.85	38	35633	8864	29529992
Acute myocardial infarction	20.67	10.85	114	35557	48324	29490532
Diabetic neuropathy	20.57	10.85	24	35647	3729	29535127
Anticoagulation drug level above therapeutic	19.91	10.85	17	35654	1814	29537042
Tricuspid valve incompetence	19.80	10.85	36	35635	8358	29530498
Haemorrhagic fever	19.36	10.85	5	35666	27	29538829
Liver disorder	19.01	10.85	75	35596	27674	29511182
Metabolic syndrome	18.78	10.85	15	35656	1458	29537398
Muscle spasms	18.41	10.85	138	35533	64944	29473912
Drug ineffective	18.40	10.85	318	35353	362852	29176004
Meningitis streptococcal	18.25	10.85	5	35666	35	29538821
Low density lipoprotein increased	18.19	10.85	23	35648	3881	29534975
Euglycaemic diabetic ketoacidosis	18.19	10.85	19	35652	2611	29536245
Blood creatinine increased	17.97	10.85	169	35502	84933	29453923
Diastolic dysfunction	17.78	10.85	26	35645	5038	29533818
Chromaturia	17.53	10.85	44	35627	12758	29526098
Mitral valve incompetence	17.49	10.85	45	35626	13248	29525608
Chondrocalcinosis	17.23	10.85	8	35663	288	29538568
Intentional product use issue	16.65	10.85	16	35655	42482	29496374
Cardiac failure congestive	16.63	10.85	153	35518	76428	29462428
Cytomegalovirus infection	16.23	10.85	4	35667	23211	29515645
Platelet count decreased	16.22	10.85	68	35603	104604	29434252
Breast cyst	15.91	10.85	4	35667	19	29538837
Diabetes mellitus inadequate control	15.88	10.85	41	35630	12093	29526763
Diabetic ketoacidosis	15.83	10.85	49	35622	16024	29522832
Obesity	15.77	10.85	36	35635	9827	29529029
Intraocular pressure decreased	15.71	10.85	5	35666	62	29538794
Hepatitis acute	15.61	10.85	28	35643	6434	29532422
Bundle branch block left	15.57	10.85	25	35646	5252	29533604
Thrombocytopenia	15.56	10.85	97	35574	134726	29404130
Treatment failure	15.56	10.85	13	35658	36926	29501930
Libido disorder	15.34	10.85	7	35664	242	29538614
Erectile dysfunction	15.13	10.85	52	35619	17957	29520899
Glutamate dehydrogenase increased	15.09	10.85	3	35668	3	29538853
Testicular oedema	14.90	10.85	5	35666	74	29538782
Type 2 diabetes mellitus	14.89	10.85	43	35628	13538	29525318
Ketonuria	14.69	10.85	9	35662	571	29538285
Supraventricular tachycardia	14.62	10.85	35	35636	9849	29529007
Respiratory failure	14.50	10.85	64	35607	97067	29441789
Carotid artery stenosis	14.34	10.85	22	35649	4447	29534409
Dyslipidaemia	14.30	10.85	26	35645	6035	29532821
Retinal vein occlusion	14.26	10.85	13	35658	1512	29537344
Sleep apnoea syndrome	14.08	10.85	50	35621	17549	29521307
Lipase increased	13.96	10.85	31	35640	8306	29530550
Electrocardiogram Q wave abnormal	13.78	10.85	7	35664	308	29538548
Respiratory arrest	13.71	10.85	7	35664	25826	29513030
Hepatojugular reflux	13.62	10.85	8	35663	470	29538386
Pyrexia	13.54	10.85	255	35416	287367	29251489
Leukopenia	13.50	10.85	29	35642	55174	29483682
Febrile neutropenia	13.34	10.85	80	35591	112160	29426696
Procedural haemorrhage	13.18	10.85	15	35656	2268	29536588
Chronic kidney disease	13.14	10.85	82	35589	36334	29502522
Cerebrovascular accident	13.02	10.85	146	35525	76765	29462091
Coma acidotic	13.02	10.85	3	35668	9	29538847
Foetal exposure during pregnancy	12.98	10.85	13	35658	33854	29505002
Optic neuropathy	12.84	10.85	13	35658	1722	29537134
Drug resistance	12.75	10.85	5	35666	21535	29517321
Rheumatoid arthritis	12.71	10.85	12	35659	32140	29506716
Malignant neoplasm progression	12.71	10.85	46	35625	73813	29465043
Cardiomyopathy	12.69	10.85	43	35628	14744	29524112
Medulloblastoma	12.68	10.85	4	35667	48	29538808
Lung disorder	12.64	10.85	71	35600	30291	29508565
Weight decreased	12.40	10.85	253	35418	150652	29388204
Occult blood	12.32	10.85	8	35663	562	29538294
Glucose tolerance impaired	12.30	10.85	16	35655	2778	29536078
Serotonin syndrome	12.27	10.85	3	35668	17509	29521347
Gamma-glutamyltransferase increased	12.13	10.85	64	35607	26673	29512183
Hepatic enzyme increased	12.12	10.85	76	35595	33723	29505133
Coronary artery occlusion	12.09	10.85	33	35638	10061	29528795
Loss of bladder sensation	12.06	10.85	4	35667	57	29538799
Papillary renal cell carcinoma	12.01	10.85	5	35666	138	29538718
Pancytopenia	11.70	10.85	56	35615	83112	29455744
Angina unstable	11.53	10.85	34	35637	10831	29528025
Renal impairment	11.41	10.85	149	35522	81184	29457672
Radicular pain	11.20	10.85	4	35667	72	29538784
Sepsis	11.19	10.85	114	35557	142568	29396288
Blood glucose decreased	11.16	10.85	36	35635	12033	29526823
Retinal disorder	11.12	10.85	9	35662	891	29537965
Ureteral disorder	10.90	10.85	5	35666	175	29538681
Asthenia	10.88	10.85	338	35333	214912	29323944

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pancreatitis acute	357.23	9.97	298	56261	42557	64399616
Rhabdomyolysis	229.70	9.97	339	56220	91387	64350786
High density lipoprotein decreased	219.92	9.97	94	56465	3852	64438321
Pancreatitis	219.48	9.97	266	56293	59341	64382832
Blood triglycerides increased	193.00	9.97	148	56411	18718	64423455
Acute kidney injury	154.35	9.97	789	55770	448451	63993722
Myalgia	140.51	9.97	379	56180	158238	64283935
Hypertriglyceridaemia	132.71	9.97	96	56463	11109	64431064
Myocardial infarction	130.93	9.97	380	56179	165441	64276732
Blood creatine phosphokinase increased	128.97	9.97	204	56355	58354	64383819
Coronary artery disease	122.83	9.97	203	56356	60230	64381943
Renal failure	84.31	9.97	349	56210	181339	64260834
Off label use	80.66	9.97	285	56274	632521	63809652
Synovitis	73.86	9.97	3	56556	99087	64343086
Drug abuse	70.48	9.97	15	56544	132359	64309814
Drug ineffective	68.18	9.97	445	56114	839802	63602371
International normalised ratio increased	58.19	9.97	177	56382	78990	64363183
Hepatic steatosis	56.17	9.97	99	56460	30908	64411265
Contraindicated product administered	55.82	9.97	13	56546	107816	64334357
Rheumatoid arthritis	54.21	9.97	39	56520	164255	64277918
Pulmonary valve disease	52.07	9.97	16	56543	247	64441926
Infusion related reaction	49.28	9.97	43	56516	164424	64277749
Pericardial disease	49.17	9.97	18	56541	486	64441687
Treatment failure	48.22	9.97	21	56538	116795	64325378
Myopathy	46.59	9.97	67	56492	17613	64424560
Drug-induced liver injury	44.29	9.97	116	56443	47527	64394646
Mitral valve disease	44.14	9.97	28	56531	2610	64439563
Confabulation	43.33	9.97	16	56543	443	64441730
Maternal exposure during pregnancy	43.27	9.97	15	56544	95869	64346304
Drug interaction	43.04	9.97	496	56063	361587	64080586
Blood glucose increased	42.03	9.97	184	56375	97889	64344284
Hyperlipidaemia	41.15	9.97	73	56486	22903	64419270
Hand deformity	40.58	9.97	4	56555	62767	64379406
Stenosis	40.02	9.97	23	56536	1792	64440381
Dyslipidaemia	38.56	9.97	44	56515	9198	64432975
Glycosylated haemoglobin increased	38.31	9.97	58	56501	15961	64426212
Apolipoprotein A-I decreased	38.04	9.97	8	56551	21	64442152
Toxicity to various agents	37.81	9.97	177	56382	363336	64078837
Glossodynia	37.28	9.97	6	56553	64690	64377483
Diabetes mellitus inadequate control	37.23	9.97	67	56492	21254	64420919
Joint swelling	36.10	9.97	85	56474	215297	64226876
Therapeutic product effect decreased	35.97	9.97	29	56530	115322	64326851
Physical examination abnormal	35.93	9.97	12	56547	245	64441928
Systemic lupus erythematosus	35.26	9.97	12	56547	77600	64364573
Skin weeping	35.21	9.97	15	56544	609	64441564
Infection	34.26	9.97	69	56490	184811	64257362
Pemphigus	34.15	9.97	6	56553	60695	64381478
Fibrillary glomerulonephritis	33.23	9.97	8	56551	45	64442128
Renal impairment	32.95	9.97	217	56342	134800	64307373
Acute myocardial infarction	32.34	9.97	134	56425	69584	64372589
Cardiac failure congestive	31.95	9.97	210	56349	130370	64311803
Rectosigmoid cancer	31.75	9.97	11	56548	252	64441921
Diabetic metabolic decompensation	31.45	9.97	23	56536	2705	64439468
Jaundice	30.65	9.97	103	56456	48409	64393764
Cardiac discomfort	30.06	9.97	16	56543	1073	64441100
Lichen nitidus	29.67	9.97	8	56551	75	64442098
Hypersensitivity	29.47	9.97	82	56477	196370	64245803
Erectile dysfunction	29.18	9.97	45	56514	12582	64429591
Cholelithiasis	29.09	9.97	97	56462	45409	64396764
Photosensitivity reaction	29.08	9.97	55	56504	18118	64424055
Myoglobin blood increased	29.07	9.97	22	56537	2725	64439448
Pancreatic neoplasm	28.96	9.97	17	56542	1378	64440795
Hepatorenal failure	28.95	9.97	16	56543	1156	64441017
Blood triglycerides abnormal	28.38	9.97	11	56548	349	64441824
Chromaturia	27.39	9.97	61	56498	22550	64419623
Lichenoid keratosis	27.37	9.97	23	56536	3311	64438862
Psoriasis	27.34	9.97	130	56429	71573	64370600
Hypoglycaemia	27.34	9.97	153	56406	89739	64352434
Blood creatinine increased	27.17	9.97	208	56351	135574	64306599
Euglycaemic diabetic ketoacidosis	26.46	9.97	28	56531	5382	64436791
Hepatic function abnormal	26.29	9.97	119	56440	64194	64377979
Pancreatitis necrotising	26.01	9.97	22	56537	3195	64438978
Ischaemic cardiomyopathy	25.93	9.97	31	56528	6807	64435366
Lower respiratory tract infection	25.68	9.97	27	56532	94587	64347586
Gamma-glutamyltransferase increased	25.52	9.97	97	56462	48413	64393760
Wound	25.41	9.97	18	56541	76459	64365714
Glycogen storage disease type V	25.04	9.97	6	56553	33	64442140
Cerebrovascular accident	24.92	9.97	206	56353	137377	64304796
Medulloblastoma	24.79	9.97	7	56552	79	64442094
Nephrosclerosis	24.62	9.97	16	56543	1555	64440618
Mitral valve incompetence	24.57	9.97	63	56496	25475	64416698
Ectopic gastric mucosa	24.39	9.97	5	56554	11	64442162
Fall	24.26	9.97	506	56053	416320	64025853
Hyperglycaemia	23.58	9.97	111	56448	60857	64381316
Asthenia	22.79	9.97	513	56046	427531	64014642
Death	22.65	9.97	293	56266	482412	63959761
Hepatitis acute	22.02	9.97	41	56518	13348	64428825
Chronic cutaneous lupus erythematosus	21.65	9.97	8	56551	222	64441951
Low density lipoprotein increased	21.38	9.97	30	56529	7710	64434463
Pulmonary embolism	21.32	9.97	209	56350	146147	64296026
Metabolic syndrome	20.95	9.97	17	56542	2331	64439842
Intentional overdose	20.88	9.97	29	56530	89915	64352258
Ventricular arrhythmia	20.87	9.97	29	56530	7386	64434787
Arthropathy	20.85	9.97	47	56512	120920	64321253
Rheumatoid factor positive	20.67	9.97	3	56556	34935	64407238
Cholestasis	20.61	9.97	86	56473	44786	64397387
Echocardiogram abnormal	20.44	9.97	15	56544	1774	64440399
Pericarditis	20.39	9.97	15	56544	62501	64379672
Change of bowel habit	20.39	9.97	17	56542	2421	64439752
Cytomegalovirus infection	20.23	9.97	4	56555	37195	64404978
Chronic kidney disease	19.94	9.97	102	56457	57817	64384356
Left ventricular dysfunction	19.71	9.97	45	56514	16909	64425264
Alkalosis hypochloraemic	19.35	9.97	9	56550	451	64441722
Carotid artery stenosis	19.34	9.97	29	56530	7912	64434261
Kidney fibrosis	18.74	9.97	18	56541	3083	64439090
Stomatitis	18.55	9.97	43	56516	109562	64332611
Tricuspid valve incompetence	18.53	9.97	44	56515	16959	64425214
Blood cholesterol increased	18.53	9.97	90	56469	49976	64392197
Nasopharyngitis	18.34	9.97	99	56460	195974	64246199
Product use in unapproved indication	18.33	9.97	86	56473	176532	64265641
Subacute kidney injury	18.16	9.97	4	56555	14	64442159
Product use issue	18.12	9.97	70	56489	151645	64290528
Myotonia	18.09	9.97	7	56552	221	64441952
Chest pain	18.06	9.97	299	56260	235681	64206492
Alopecia	17.59	9.97	80	56479	165610	64276563
Multiple fractures	17.56	9.97	24	56535	6016	64436157
Coronary artery occlusion	17.42	9.97	38	56521	13853	64428320
Narcotic bowel syndrome	17.36	9.97	7	56552	247	64441926
Mucosal dryness	17.35	9.97	17	56542	2984	64439189
Musculoskeletal stiffness	17.32	9.97	53	56506	123153	64319020
Hypertonic bladder	17.27	9.97	18	56541	3400	64438773
Electrocardiogram Q wave abnormal	17.18	9.97	8	56551	402	64441771
Dilatation ventricular	17.12	9.97	19	56540	3851	64438322
Normochromic normocytic anaemia	17.11	9.97	25	56534	6665	64435508
Exposure during pregnancy	17.09	9.97	26	56533	77649	64364524
Testicular oedema	17.06	9.97	5	56554	65	64442108
Blood cholesterol abnormal	17.04	9.97	16	56543	2665	64439508
Diastolic dysfunction	16.93	9.97	29	56530	8846	64433327
Bundle branch block left	16.84	9.97	31	56528	10003	64432170
Wheezing	16.76	9.97	28	56531	80551	64361622
Arterial spasm	16.60	9.97	6	56553	156	64442017
Productive cough	16.59	9.97	24	56535	73179	64368994
Diabetes mellitus	16.30	9.97	107	56452	66367	64375806
Rales	16.16	9.97	39	56520	15190	64426983
Hepatic fibrosis	16.05	9.97	22	56537	5530	64436643
Swelling	16.05	9.97	79	56480	160139	64282034
Diabetic ketoacidosis	15.96	9.97	60	56499	29785	64412388
Ocular icterus	15.96	9.97	21	56538	5077	64437096
Mobility decreased	15.92	9.97	32	56527	85808	64356365
Angina unstable	15.76	9.97	39	56520	15428	64426745
Impaired healing	15.59	9.97	18	56541	60455	64381718
Malignant neoplasm progression	15.55	9.97	49	56510	112822	64329351
Dialysis	15.52	9.97	41	56518	16879	64425294
Haemorrhagic fever	15.51	9.97	4	56555	31	64442142
Platelet count decreased	15.50	9.97	85	56474	167626	64274547
Catheter site thrombosis	15.46	9.97	6	56553	191	64441982
Xanthoma	15.46	9.97	6	56553	191	64441982
Chondrocalcinosis	15.43	9.97	9	56550	721	64441452
Anticoagulation drug level above therapeutic	15.32	9.97	16	56543	3029	64439144
Hepatojugular reflux	15.27	9.97	8	56551	519	64441654
Oedema peripheral	15.18	9.97	264	56295	210053	64232120
Polymyositis	15.02	9.97	15	56544	2695	64439478
Glomerular filtration rate decreased	14.59	9.97	44	56515	19528	64422645
Liver disorder	14.40	9.97	88	56471	53263	64388910
Pancytopenia	14.16	9.97	71	56488	143238	64298935
Essential hypertension	14.15	9.97	20	56539	5174	64436999
Aspartate aminotransferase increased	14.14	9.97	164	56395	119624	64322549
Hepatitis	14.13	9.97	78	56481	45504	64396669
Arteriosclerosis	14.08	9.97	38	56521	15839	64426334
Asthma	14.08	9.97	40	56519	95185	64346988
Sleep disorder due to general medical condition, insomnia type	13.92	9.97	3	56556	26267	64415906
Cardiomegaly	13.84	9.97	49	56510	23635	64418538
Orthopnoea	13.82	9.97	27	56532	9107	64433066
Thirst	13.73	9.97	35	56524	14102	64428071
Irritable bowel syndrome	13.49	9.97	8	56551	37361	64404812
Congestive hepatopathy	13.43	9.97	17	56542	3956	64438217
Drug resistance	13.42	9.97	7	56552	35095	64407078
Blood urea increased	13.32	9.97	75	56484	44078	64398095
Angina pectoris	13.22	9.97	76	56483	45005	64397168
Hepatocellular injury	13.10	9.97	76	56483	45159	64397014
Folliculitis	13.06	9.97	5	56554	30072	64412101
Diabetic neuropathy	13.00	9.97	20	56539	5581	64436592
Intraocular pressure decreased	12.77	9.97	5	56554	163	64442010
Thrombocytopenia	12.75	9.97	130	56429	223671	64218502
Electrocardiogram abnormal	12.70	9.97	33	56526	13448	64428725
Meningitis streptococcal	12.55	9.97	5	56554	171	64442002
Loss of bladder sensation	12.50	9.97	4	56555	71	64442102
Glycosuria	12.46	9.97	12	56547	2062	64440111
Coronary artery bypass	12.43	9.97	20	56539	5795	64436378
Aortic arteriosclerosis	12.43	9.97	23	56536	7453	64434720
Intra-abdominal haematoma	12.43	9.97	13	56546	2466	64439707
Myositis	12.38	9.97	37	56522	16340	64425833
Anhedonia	12.35	9.97	33	56526	13673	64428500
Lipase increased	12.31	9.97	34	56525	14368	64427805
Acute coronary syndrome	12.20	9.97	41	56518	19269	64422904
Occult blood	12.19	9.97	10	56549	1392	64440781
Lipids increased	12.10	9.97	10	56549	1407	64440766
Anaemia macrocytic	12.08	9.97	17	56542	4381	64437792
Intentional product use issue	12.04	9.97	43	56516	95321	64346852
Grandiosity	12.03	9.97	7	56552	558	64441615
Radicular pain	12.03	9.97	6	56553	351	64441822
Blood glucose decreased	11.96	9.97	46	56513	23077	64419096
Cardiomyopathy	11.96	9.97	49	56510	25307	64416866
Ketonuria	11.94	9.97	9	56550	1108	64441065
Coagulation test abnormal	11.93	9.97	9	56550	1110	64441063
Proteinuria	11.86	9.97	52	56507	27671	64414502
Supraventricular tachycardia	11.81	9.97	40	56519	18867	64423306
Nephrotic syndrome	11.80	9.97	26	56533	9541	64432632
Muscle spasms	11.64	9.97	181	56378	140842	64301331
Drug intolerance	11.63	9.97	107	56452	187885	64254288
Bipolar disorder	11.49	9.97	21	56538	6740	64435433
Renal tubular necrosis	11.45	9.97	44	56515	22066	64420107
Atypical teratoid/rhabdoid tumour of CNS	11.44	9.97	3	56556	25	64442148
Cardiac disorder	11.43	9.97	86	56473	55730	64386443
Auditory disorder	11.42	9.97	6	56553	392	64441781
Palatal oedema	11.39	9.97	9	56550	1188	64440985
Glutamate dehydrogenase increased	11.24	9.97	3	56556	27	64442146
Shigella infection	11.24	9.97	3	56556	27	64442146
Febrile neutropenia	11.10	9.97	108	56451	187549	64254624
Pneumonia	10.98	9.97	391	56168	559185	63882988
Urticaria pigmentosa	10.86	9.97	3	56556	31	64442142
Ureteric cancer recurrent	10.86	9.97	3	56556	31	64442142
Renin decreased	10.79	9.97	4	56555	112	64442061
Libido disorder	10.78	9.97	5	56554	249	64441924
Diabetic gastroparesis	10.74	9.97	5	56554	251	64441922
Completed suicide	10.57	9.97	136	56423	224278	64217895
Retinal vein occlusion	10.44	9.97	13	56546	2975	64439198
Therapeutic product effect incomplete	10.37	9.97	51	56508	103431	64338742
Optic neuropathy	10.36	9.97	13	56546	2998	64439175
Adrenal adenoma	10.36	9.97	8	56551	1021	64441152
Therapy non-responder	10.25	9.97	27	56532	65872	64376301
Myocardial ischaemia	10.24	9.97	44	56515	23207	64418966
Gastrointestinal haemorrhage	10.24	9.97	168	56391	132144	64310029
Transient ischaemic attack	10.16	9.97	70	56489	44112	64398061
Device dislocation	10.10	9.97	3	56556	21175	64420998
Haematoma muscle	10.07	9.97	10	56549	1783	64440390
Pancreatitis chronic	10.05	9.97	14	56545	3572	64438601
Hyperkalaemia	10.01	9.97	134	56425	100995	64341178

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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
FDA EPC	N0000175596	Peroxisome Proliferator Receptor alpha Agonist
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

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

Disease	Relation	SNOMED_ID	DOID
Hypercholesterolemia	indication	13644009
Hyperlipidemia	indication	55822004	DOID:1168
Hypoalphalipoproteinemia	indication	190785000
Familial hypercholesterolemia - heterozygous	indication	238079002
Mixed hyperlipidemia	indication	267434003
Hypertriglyceridemia	indication	302870006
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	8026281	April 22, 2025	TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
30MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	8026281	April 22, 2025	TREATING SEVERE HYPERTRIGLYCERIDEMIA
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	8026281	April 22, 2025	TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	8026281	April 22, 2025	TREATING SEVERE HYPERTRIGLYCERIDEMIA
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	9314447	May 31, 2033	TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	RX	CAPSULE	ORAL	9314447	May 31, 2033	TREATING SEVERE HYPERTRIGLYCERIDEMIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Peroxisome proliferator-activated receptor alpha	Nuclear hormone receptor	Q07869	PPARA_HUMAN	AGONIST	IC50	6	CHEMBL	CHEMBL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	6.22	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	5.91	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	4.33	DRUG MATRIX
Beta-3 adrenergic receptor	GPCR	P13945	ADRB3_HUMAN		Ki	4.03	DRUG MATRIX
Sodium-dependent dopamine transporter	Transporter	Q01959	SC6A3_HUMAN		Ki	5.16	DRUG MATRIX
Adenosine receptor A3	GPCR	P0DMS8	AA3R_HUMAN		Ki	5.49	DRUG MATRIX
Acetylcholinesterase	Enzyme	P22303	ACES_HUMAN		IC50	4.81	DRUG MATRIX
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN		EC50	6.24	CHEMBL
Sodium-dependent noradrenaline transporter	Transporter	P23975	SC6A2_HUMAN		Ki	4.67	DRUG MATRIX
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Kd	7.74	CHEMBL
Cruzipain	Enzyme		CYSP_TRYCR		IC50	4.21	CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tricor	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3173	TABLET	48 mg	ORAL	NDA	28 sections
Tricor	HUMAN PRESCRIPTION DRUG LABEL	1	0074-3189	TABLET	145 mg	ORAL	NDA	28 sections
Tricor	HUMAN PRESCRIPTION DRUG LABEL	1	0074-6122	TABLET	48 mg	ORAL	NDA	28 sections
Tricor	HUMAN PRESCRIPTION DRUG LABEL	1	0074-6123	TABLET	145 mg	ORAL	NDA	28 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	0115-0533	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	0115-5522	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
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	13668-438	CAPSULE	200 mg	ORAL	ANDA	14 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	13668-439	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	13668-440	CAPSULE	67 mg	ORAL	ANDA	14 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-162	TABLET, FILM COATED	54 mg	ORAL	ANDA	26 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-163	TABLET, FILM COATED	160 mg	ORAL	ANDA	26 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	16714-739	CAPSULE	67 mg	ORAL	ANDA	20 sections