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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:

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

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Approvals:

Date	Agency	Company	Orphan
April 14, 2011	EMA	LABORATOIRES SMB S.A.
Dec. 31, 1993	FDA	ABBVIE

FDA Adverse Event Reporting System (Female)

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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	258.28	10.86	215	38841	43736	63406230
Pancreatitis acute	193.93	10.86	149	38907	27017	63422949
Acute kidney injury	176.87	10.86	454	38602	262961	63187005
Blood triglycerides increased	166.99	10.86	101	38955	12387	63437579
Pancreatitis	164.81	10.86	176	38880	48879	63401087
Myalgia	118.97	10.86	272	38784	146257	63303709
Contraindicated product administered	93.13	10.86	12	39044	217636	63232330
Pemphigus	92.58	10.86	5	39051	183721	63266245
Systemic lupus erythematosus	85.91	10.86	13	39043	208905	63241061
Hand deformity	84.75	10.86	3	39053	159454	63290512

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FDA Adverse Event Reporting System (Male)

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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	261.92	10.72	231	38770	27910	34890020
High density lipoprotein decreased	174.82	10.72	82	38919	3278	34914652
Pancreatitis	143.23	10.72	196	38805	38695	34879235
Blood triglycerides increased	129.21	10.72	115	38886	14044	34903886
Blood creatine phosphokinase increased	94.32	10.72	175	38826	44682	34873248
Myocardial infarction	94.10	10.72	323	38678	120762	34797168
Coronary artery disease	91.17	10.72	180	38821	48125	34869805
Myalgia	90.11	10.72	251	38750	83859	34834071
Hypertriglyceridaemia	83.87	10.72	72	38929	8376	34909554
Drug abuse	76.66	10.72	10	38991	99086	34818844

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FDA Adverse Event Reporting System (Geriatric)

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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	405.34	10.09	326	62487	49278	79632297
Rhabdomyolysis	254.83	10.09	358	62455	102773	79578802
Pancreatitis	235.17	10.09	280	62533	68295	79613280
High density lipoprotein decreased	227.74	10.09	98	62715	4557	79677018
Blood triglycerides increased	212.74	10.09	157	62656	20883	79660692
Acute kidney injury	190.41	10.09	861	61952	518543	79163032
Hypertriglyceridaemia	156.35	10.09	107	62706	12633	79668942
Myalgia	152.31	10.09	403	62410	185238	79496337
Myocardial infarction	145.29	10.09	394	62419	183735	79497840
Blood creatine phosphokinase increased	140.78	10.09	214	62599	65876	79615699

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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
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
FDA CS	M0199111	PPAR alpha

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

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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
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

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

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Acid dissociation constants calculated using MoKa v3.0.0

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
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
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)
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	DISCN	CAPSULE	ORAL	8026281	April 22, 2025	TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	DISCN	CAPSULE	ORAL	8026281	April 22, 2025	TREATING SEVERE HYPERTRIGLYCERIDEMIA
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
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)
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	DISCN	CAPSULE	ORAL	8026281	April 22, 2025	TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
90MG	ANTARA (MICRONIZED)	LUPIN	N021695	Oct. 18, 2013	DISCN	CAPSULE	ORAL	8026281	April 22, 2025	TREATING SEVERE HYPERTRIGLYCERIDEMIA

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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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
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN		IC50	5.29	CHEMBL
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

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External reference:

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ID	Source
003789	NDDF
108603001	SNOMEDCT_US
12032	MMSL
3339	PUBCHEM_CID
386879008	SNOMEDCT_US
3996	INN_ID
4021098	VUID
4021098	VANDF
44688	MMSL
7186	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0511	CAPSULE	67 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0511	CAPSULE	67 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0522	CAPSULE	134 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0522	CAPSULE	134 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0533	CAPSULE	200 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-0533	CAPSULE	200 mg	ORAL	ANDA	12 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1522	TABLET	40 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Fenofibrate	HUMAN PRESCRIPTION DRUG LABEL	1	0115-1523	TABLET	120 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
FENOFIBRATE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-5511	TABLET	54 mg	ORAL	ANDA	23 sections
FENOFIBRATE	HUMAN PRESCRIPTION DRUG LABEL	1	0115-5511	TABLET	54 mg	ORAL	ANDA	23 sections

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