Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fosinopril sodium
Drug ID BADD_D00968
Description Fosinopril is a phosphinic acid-containing ester prodrug that belongs to the angiotensin-converting enzyme (ACE) inhibitor class of medications. It is rapidly hydrolyzed to fosinoprilat, its principle active metabolite. Fosinoprilat inhibits ACE, the enzyme responsible for the conversion of angiotensin I (ATI) to angiotensin II (ATII). ATII regulates blood pressure and is a key component of the renin-angiotensin-aldosterone system (RAAS). Fosinopril may be used to treat mild to moderate hypertension, as an adjunct in the treatment of congestive heart failure, and to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.
Indications and Usage For treating mild to moderate hypertension, use as an adjunct in treating congestive heart failure, and may be used to slow the rate of progression of renal disease in hypertensive individuals with diabetes mellitus and microalbuminuria or overt nephropathy.
Marketing Status approved
ATC Code C09AA09
DrugBank ID DB00492
KEGG ID D00622
MeSH ID D017328
PubChem ID 23666105
TTD Drug ID D0X8KY
NDC Product Code 76282-201; 76282-202; 65862-393; 65977-0004; 65862-472; 65862-471; 62135-042; 62135-043; 71335-1115; 16571-772; 71335-9703; 43547-388; 65862-473; 76282-200; 43547-387; 62135-041; 16571-770; 16571-771
UNII NW2RTH6T2N
Synonyms Fosinopril | Fosenopril | Fosinil | Fositens | Fosinopril Sodium | Sodium, Fosinopril | Fosinopril, (1(S*(R*)),2 alpha,4 beta)-Isomer | Fosinopril, (1(S*(R*)),2 alpha,4 alpha)-(D-Pro)-Isomer | Tenso Stop | Tensocardil | Fozitec | Hiperlex | Monopril | Fosinorm | Newace | Staril | SQ-28,555 | SQ 28,555 | SQ28,555 | SQ-28555 | SQ 28555 | SQ28555 | Dynacil | Fosinopril, (1(S*(S*)),2 alpha,4 beta)-Isomer
Chemical Information
Molecular Formula C30H45NNaO7P
CAS Registry Number 88889-14-9
SMILES CCC(=O)OC(C(C)C)OP(=O)(CCCCC1=CC=CC=C1)CC(=O)N2CC(CC2C(=O)[O-])C3CCCCC3.[Na+]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Rhinitis11.01.13.004; 22.07.03.006--
Sexual dysfunction21.03.02.003; 19.08.05.002--Not Available
Shock24.06.02.002--Not Available
Sinusitis22.07.03.007; 11.01.13.005--
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Sudden death08.04.01.003; 02.03.04.013--
Syncope24.06.02.012; 17.02.04.008; 02.11.04.015--
Tachycardia02.03.02.007--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tracheobronchitis22.07.01.016; 11.01.09.020--Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Vasculitis10.02.02.006; 24.12.04.027--
Vertigo17.02.12.002; 04.04.01.003--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Red blood cell sedimentation rate increased13.01.03.001--Not Available
Transaminases increased13.03.04.036--Not Available
Weight abnormal13.15.01.016--Not Available
Serositis08.01.05.006--Not Available
Blood alkaline phosphatase increased13.04.02.004--
Antinuclear antibody positive13.06.01.003--Not Available
Appetite disorder14.03.01.004; 19.09.01.002--Not Available
Abnormal behaviour19.01.01.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
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