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

Stem definition	Drug id	CAS RN
angiotensin-converting enzyme inhibitors	1245	98048-97-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fosinopril fosinopril sodium fosenopril fozitec fosinapril	A phosphinic acid-containing angiotensin-converting enzyme inhibitor that is effective in the treatment of hypertension. It is a prodrug that is converted to its active metabolite fosinoprilat. Molecular weight: 563.67 Formula: C30H46NO7P CLOGP: 7.45 LIPINSKI: 2 HAC: 8 HDO: 1 TPSA: 110.21 ALOGS: -5.75 ROTB: 15 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fosinopril
fosinopril sodium
fosenopril
fozitec
fosinapril

A phosphinic acid-containing angiotensin-converting enzyme inhibitor that is effective in the treatment of hypertension. It is a prodrug that is converted to its active metabolite fosinoprilat.

Molecular weight: 563.67
Formula: C30H46NO7P
CLOGP: 7.45
LIPINSKI: 2
HAC: 8
HDO: 1
TPSA: 110.21
ALOGS: -5.75
ROTB: 15

Status: OFP

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

Drug dosage:

Dose	Unit	Route
15	mg	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	34 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.36 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	100 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
May 16, 1991	FDA

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
Cardiac failure congestive	75.45	17.67	56	4060	92377	63392529
Myocardial infarction	63.05	17.67	52	4064	99841	63385065
Diverticular perforation	60.78	17.67	18	4098	3524	63481382
Cerebrovascular accident	42.20	17.67	43	4073	107981	63376925
International normalised ratio increased	30.99	17.67	25	4091	46400	63438506
Steatorrhoea	30.68	17.67	7	4109	492	63484414
Hypertensive crisis	29.53	17.67	16	4100	15270	63469636
Angioedema	28.21	17.67	24	4092	47941	63436965
Body temperature decreased	27.83	17.67	17	4099	20302	63464604
Orthostatic hypotension	27.43	17.67	21	4095	36139	63448767

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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
Angioedema	166.76	18.25	89	4946	37285	34914611
Bradycardia	103.36	18.25	86	4949	75332	34876564
Acute kidney injury	81.79	18.25	152	4883	304836	34647060
Cardiac failure congestive	60.56	18.25	67	4968	83203	34868693
Hyperkalaemia	59.59	18.25	61	4974	69328	34882568
Hypoglycaemia	58.08	18.25	54	4981	54586	34897310
Myocardial infarction	53.65	18.25	76	4959	121009	34830887
Treatment noncompliance	44.65	18.25	35	5000	28065	34923831
Rhabdomyolysis	38.14	18.25	48	4987	68115	34883781
Coronary artery disease	37.03	18.25	40	4995	48265	34903631

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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
Angioedema	163.59	15.25	100	8066	75935	79660287
Cardiac failure congestive	117.37	15.25	105	8061	142297	79593925
Myocardial infarction	116.02	15.25	117	8049	184012	79552210
Bradycardia	96.25	15.25	92	8074	135465	79600757
Acute kidney injury	93.63	15.25	180	7986	519224	79216998
Hyperkalaemia	81.86	15.25	78	8088	114320	79621902
Cerebrovascular accident	57.44	15.25	75	8091	155217	79581005
Coronary artery disease	55.28	15.25	49	8117	65425	79670797
Hypoglycaemia	48.79	15.25	56	8110	101538	79634684
Rhabdomyolysis	46.44	15.25	55	8111	103076	79633146

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	C09AA09	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, PLAIN ACE inhibitors, plain
ATC	C09BA09	CARDIOVASCULAR SYSTEM AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM ACE INHIBITORS, COMBINATIONS ACE inhibitors and diuretics
CHEBI has role	CHEBI:35457	ACE inhibitor
CHEBI has role	CHEBI:35674	antihypertensive drugs
CHEBI has role	CHEBI:50266	Prodrugs
FDA EPC	N0000175562	Angiotensin Converting Enzyme Inhibitor
FDA MoA	N0000000181	Angiotensin-converting Enzyme Inhibitors
MeSH PA	D000806	Angiotensin-Converting Enzyme Inhibitors
MeSH PA	D000889	Anti-Arrhythmia Agents
MeSH PA	D000959	Antihypertensive 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
Hypertensive disorder	indication	38341003	DOID:10763
Chronic heart failure	indication	48447003
Atrial fibrillation	off-label use	49436004	DOID:0060224
Diabetic renal disease	off-label use	127013003
Acute scleroderma renal crisis	off-label use	236503001
Diastolic heart failure	off-label use	418304008	DOID:9775
Nondiabetic Proteinuric Nephropathy	off-label use
Hypertension due to Scleroderma	off-label use
Anuria	contraindication	2472002	DOID:2983
Hypercholesterolemia	contraindication	13644009

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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	3.98	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])	Mechanism action	Bioact source	MoA source
Angiotensin-converting enzyme	Enzyme	P12821	ACE_HUMAN	INHIBITOR	IC50	9		CHEMBL	CHEMBL
Angiotensin-converting enzyme	Enzyme		ACE_RABIT		Ki	8.82		CHEMBL

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External reference:

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ID	Source
KS8	PDB_CHEM_ID
003594	NDDF
004501	NDDF
108569005	SNOMEDCT_US
108570006	SNOMEDCT_US
1546393	RXNORM
372510000	SNOMEDCT_US
4020186	VANDF
4020531	VUID
4020531	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Fosinopril Sodium	Human Prescription Drug Label	1	16571-770	TABLET	10 mg	ORAL	ANDA	21 sections
Fosinopril Sodium	Human Prescription Drug Label	1	16571-771	TABLET	20 mg	ORAL	ANDA	21 sections
Fosinopril Sodium	Human Prescription Drug Label	1	16571-772	TABLET	40 mg	ORAL	ANDA	21 sections
Fosinopril Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	31722-200	TABLET	10 mg	ORAL	ANDA	23 sections
Fosinopril Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	31722-201	TABLET	20 mg	ORAL	ANDA	23 sections
Fosinopril Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	31722-202	TABLET	40 mg	ORAL	ANDA	23 sections
Fosinopril sodium	Human Prescription Drug Label	1	43353-870	TABLET	40 mg	ORAL	ANDA	21 sections
Fosinopril sodium	HUMAN PRESCRIPTION DRUG LABEL	1	43547-386	TABLET	10 mg	ORAL	ANDA	24 sections
Fosinopril sodium	HUMAN PRESCRIPTION DRUG LABEL	1	43547-387	TABLET	20 mg	ORAL	ANDA	24 sections
Fosinopril sodium	HUMAN PRESCRIPTION DRUG LABEL	1	43547-388	TABLET	40 mg	ORAL	ANDA	24 sections

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