Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Enalapril maleate
Drug ID BADD_D00767
Description Enalapril is a prodrug belonging to the angiotensin-converting enzyme (ACE) inhibitor drug class that works on the renin-angiotensin-aldosterone system, which is responsible for the regulation of blood pressure and fluid and electrolyte homeostasis. Enalapril is an orally-active and long-acting nonsulphydryl antihypertensive agent that suppresses the renin-angiotensin-aldosterone system to lower blood pressure. It was developed from a targeted research programmed using molecular modelling.[A18459] Being a prodrug, enalapril is rapidly biotransformed into its active metabolite, [enalaprilat], which is responsible for the pharmacological actions of enalapril. The active metabolite of enalapril competitively inhibits the ACE to hinder the production of angiotensin II, a key component of the renin-angiotensin-aldosterone system that promotes vasoconstriction and renal reabsorption of sodium ions in the kidneys. Ultimately, enalaprilat works to reduce blood pressure and blood fluid volume. Commonly marketed under the trade name Vasotec, enalapril was first approved by the FDA in 1985 for the management of hypertension, heart failure, and asymptomatic left ventricular dysfunction. It is also found in a combination product containing [hydrochlorothiazide] that is used for the management of hypertension. The active metabolite enalaprilat is also available in oral tablets and intravenous formulations for injection.
Indications and Usage Indicated for the management of essential or renovascular hypertension [L6586] as monotherapy or in combination with other antihypertensive agents, such as thiazide diuretics, for an additive effect.[label] Indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis.[label] Indicated for the management of asymptomatic left ventricular dysfunction in patients with an ejection fraction of ≤ to 35 percent to decrease the rate of development of overt heart failure and the incidence of hospitalization for heart failure.[label]
Marketing Status approved; vet_approved
ATC Code C09AA02
DrugBank ID DB00584
KEGG ID D00621
MeSH ID D004656
PubChem ID 5388961
TTD Drug ID D00SEB
NDC Product Code 0904-5502; 43744-122; 0187-0142; 50090-0692; 51672-4038; 51672-4040; 55289-694; 61919-372; 61919-813; 70518-0045; 70518-1564; 70934-875; 0904-5610; 53296-0035; 16714-442; 43547-546; 0187-0143; 50090-3378; 50090-6490; 51672-4037; 60760-392; 62135-589; 62135-592; 68645-607; 68788-8320; 70518-3715; 71335-1427; 71335-9649; 51927-3336; 51655-006; 51655-058; 51655-207; 60429-184; 63187-397; 63187-977; 68071-2670; 68788-7967; 68788-8061; 68788-8385; 70518-0028; 70518-1664; 71205-074; 71205-075; 71335-1854; 71335-1910; 60429-185; 63629-1526; 68071-1793; 68645-455; 68788-8096; 70518-1190; 55111-008; 62991-2769; 71052-103; 0187-0141; 51655-110; 51655-341; 60760-688; 63629-1522; 68645-606; 68682-712; 70518-2445; 72789-318; 49452-2706; 16714-443; 16714-445; 43547-548; 50090-4560; 50090-5976; 60760-226; 68645-456; 71335-9604; 0904-5611; 0187-0140; 52652-4001; 53808-1108; 60429-186; 62135-590; 68645-605; 68788-8437; 70518-2621; 71335-0305; 71335-1141; 72189-151; 72189-282; 16714-444; 23155-704; 50090-6437; 51672-4245; 53002-2008; 60429-183; 60760-575; 61919-277; 68071-2618; 69452-237; 70518-3572; 0904-5609; 17404-0009; 38779-0514; 43547-545; 61919-690; 68645-457; 68788-7671; 71335-0055; 71335-0478; 71335-9698; 23155-773; 31722-020; 50090-0689; 50090-3275; 60760-587; 60760-777; 62135-591; 63629-1525; 68071-3408; 68682-710; 68682-711; 68682-713; 68788-8284; 72789-329; 51552-0944; 64220-143; 66174-0074; 23155-705; 23155-772; 43547-547; 45865-404
UNII 9O25354EPJ
Synonyms Enalapril | MK-421 | MK 421 | MK421 | Renitec | Renitek | Enalapril Maleate | Maleate, Enalapril
Chemical Information
Molecular Formula C24H32N2O9
CAS Registry Number 76420-75-2
SMILES CCOC(=O)C(CCC1=CC=CC=C1)NC(C)C(=O)N2CCCC2C(=O)O.C(=CC(=O)O)C(=O)O
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)
Abdominal pain07.01.05.002--
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anosmia22.04.03.006; 17.04.04.001--
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Ataxia17.02.02.001; 08.01.02.004--
Atrial fibrillation02.03.03.002--
Atrial tachycardia02.03.03.004--
Back pain15.03.04.005--
Blood bilirubin increased13.03.04.018--
Blood creatine increased13.13.01.001--Not Available
Blood creatinine increased13.13.01.004--
Blood pressure increased13.14.03.005--Not Available
Blood urea increased13.13.01.006--Not Available
Body temperature increased13.15.01.001--Not Available
Bradycardia02.03.02.002--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm22.03.01.004; 10.01.03.012--
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