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

Stem definition	Drug id	CAS RN
	1285	25812-30-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: gemfibrosil gemfibrozil decrelip lopizid	A lipid-regulating agent that lowers elevated serum lipids primarily by decreasing serum triglycerides with a variable reduction in total cholesterol. Molecular weight: 250.34 Formula: C15H22O3 CLOGP: 3.94 LIPINSKI: 0 HAC: 3 HDO: 1 TPSA: 46.53 ALOGS: -3.95 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

gemfibrosil
gemfibrozil
decrelip
lopizid

A lipid-regulating agent that lowers elevated serum lipids primarily by decreasing serum triglycerides with a variable reduction in total cholesterol.

Molecular weight: 250.34
Formula: C15H22O3
CLOGP: 3.94
LIPINSKI: 0
HAC: 3
HDO: 1
TPSA: 46.53
ALOGS: -3.95
ROTB: 6

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
1.20	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	98 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	79.89 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)	0.50 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Dec. 21, 1981	FDA	PFIZER PHARMS

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	232.33	14.07	123	10422	43828	63434649
Drug hypersensitivity	70.95	14.07	158	10387	310529	63167948
Blood triglycerides increased	60.43	14.07	33	10512	12455	63466022
Coronary artery disease	58.19	14.07	46	10499	32331	63446146
Myocardial infarction	50.42	14.07	72	10473	99821	63378656
Blood creatine phosphokinase increased	49.94	14.07	41	10504	30389	63448088
Acute interstitial pneumonitis	43.70	14.07	12	10533	692	63477785
Cardiac failure congestive	40.00	14.07	62	10483	92371	63386106
Myalgia	37.32	14.07	78	10467	146451	63332026
Drug interaction	36.81	14.07	102	10443	229029	63249448

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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
Rhabdomyolysis	550.36	12.74	350	14700	67813	34874068
Acute kidney injury	118.19	12.74	342	14708	304646	34637235
Blood creatine phosphokinase increased	113.40	12.74	117	14933	44740	34897141
Myalgia	99.83	12.74	150	14900	83960	34857921
Blood triglycerides increased	97.43	12.74	66	14984	14093	34927788
Coronary artery disease	76.47	12.74	99	14951	48206	34893675
Myocardial infarction	64.20	12.74	153	14897	120932	34820949
Drug hypersensitivity	56.58	12.74	114	14936	80415	34861466
Off label use	56.10	12.74	59	14991	419465	34522416
Polymyositis	53.43	12.74	21	15029	1432	34940449

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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
Rhabdomyolysis	734.11	12.66	411	20710	102720	79620547
Blood creatine phosphokinase increased	168.95	12.66	140	20981	65950	79657317
Blood triglycerides increased	163.34	12.66	89	21032	20951	79702316
Coronary artery disease	147.50	12.66	129	20992	65345	79657922
Acute kidney injury	142.00	12.66	377	20744	519027	79204240
Myocardial infarction	130.14	12.66	199	20922	183930	79539337
Myalgia	121.95	12.66	194	20927	185447	79537820
Cardiac failure congestive	88.25	12.66	145	20976	142257	79581010
Drug hypersensitivity	83.46	12.66	219	20902	298697	79424570
Off label use	82.19	12.66	72	21049	907143	78816124

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C10AB04	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Fibrates
CHEBI has role	CHEBI:35679	antilipemic drugs
FDA CS	M0199111	PPAR alpha
FDA EPC	N0000175596	Peroxisome Proliferator Receptor alpha Agonist
FDA MoA	N0000175375	Peroxisome Proliferator-activated Receptor alpha Agonists
MeSH PA	D000963	Antimetabolites
MeSH PA	D065687	Cytochrome P-450 CYP2C8 Inhibitors
MeSH PA	D065607	Cytochrome P-450 Enzyme Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D000960	Hypolipidemic Agents

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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
Hypertriglyceridemia	indication	302870006
Primary Prevention of Coronary Heart Disease	indication
Hypoalphalipoproteinemia	off-label use	190785000
Primary biliary cirrhosis	contraindication	31712002	DOID:12236
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Acute nephropathy	contraindication	58574008
Leukopenia	contraindication	84828003	DOID:615
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Calculus in biliary tract	contraindication	266474003

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	5.13	acidic

Orange Book patent data (new drug applications)

None

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	EC50	4.23	IUPHAR	CHEMBL
Transthyretin	Secreted	P02766	TTHY_HUMAN		Kd	7	CHEMBL
Cytochrome P450 2C8	Enzyme	P10632	CP2C8_HUMAN		Ki	5.74	WOMBAT-PK
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		Ki	4.52	WOMBAT-PK
Peroxisome proliferator-activated receptor gamma	Nuclear hormone receptor	P37231	PPARG_HUMAN		EC50	4.17	CHEMBL
Lipoprotein lipase	Enzyme	P06858	LIPL_HUMAN				WOMBAT-PK
CDGSH iron-sulfur domain-containing protein 1	Unclassified	Q9NZ45	CISD1_HUMAN		Ki	5.14	CHEMBL
Fatty acid-binding protein, liver	Unclassified		FABPL_RAT		Ki	5.73	CHEMBL

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External reference:

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ID	Source
002050	NDDF
3439	IUPHAR_LIGAND_ID
3463	PUBCHEM_CID
35282000	SNOMEDCT_US
387189002	SNOMEDCT_US
3899	INN_ID
4018639	VUID
4018639	VANDF
4719	RXNORM
4778	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9130	TABLET, FILM COATED	600 mg	ORAL	ANDA	17 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9707	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8354	TABLET, FILM COATED	600 mg	ORAL	ANDA	15 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	0615-8354	TABLET, FILM COATED	600 mg	ORAL	ANDA	15 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	10544-569	TABLET, FILM COATED	600 mg	ORAL	ANDA	18 sections
Gemfibrozil	Human Prescription Drug Label	1	16571-784	TABLET, FILM COATED	600 mg	ORAL	ANDA	15 sections
Gemfibrozil	Human Prescription Drug Label	1	16714-101	TABLET	600 mg	ORAL	ANDA	18 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	21695-732	TABLET, FILM COATED	600 mg	ORAL	ANDA	17 sections
Gemfibrozil	HUMAN PRESCRIPTION DRUG LABEL	1	24658-260	TABLET, FILM COATED	600 mg	ORAL	ANDA	17 sections
GEMFIBROZIL	HUMAN PRESCRIPTION DRUG LABEL	1	31722-128	TABLET	600 mg	ORAL	ANDA	11 sections

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