This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ENALAPRIL MALEATE as soon as possible. [See Warnings and Precautions ( 5.1 )] • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. [See Warnings and Precautions ( 5.1 )] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue ENALAPRIL MALEATE as soon as possible ( 5.1 ). • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
Enalapril maleate is an angiotensin-converting enzyme inhibitor indicated for: treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ). treatment of symptomatic heart failure ( 1.2 ). treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure ( 1.3 ). 1.1 Hypertension Enalapril maleate is indicated for the treatment of hypertension, to lower blood pressure in adults and children older than one month [see Pediatric Use ( 8.4 ) and Clinical Studies ( 14 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smo...
Enalapril maleate is contraindicated in patients with: •a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme (ACE) inhibitor [see Warnings and Precautions ( 5.2 )]. •hereditary or idiopathic angioedema [see Warnings and Precautions ( 5.2 )] . Do not co-administer aliskiren with enalapril maleate in patients with diabetes [see Drug Interactions ( 7.2 )] . Enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see Warnings and Precautions ( 5.2 )] . Hypersensitivity related to previous treatment with an ACEI ( 4 ). Hereditary or idiopathic angioedema ( 4 ). Do not co-administer aliskiren in patients with diabetes ( 4 ). In combination with a neprilysin inhibitor ( 4 ).
Angioedema and Anaphylactoid Reactions ( 5.2 ). Impaired Renal Function: Assess renal function ( 5.5 ). Hyperkalemia ( 5.6 ). 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue enalapril maleate as soon as possible [see Use in Specific Populations ( 8.1 )] . 5.2 Angioedema and Anaphylactoid Reactions Angioedema Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with angiotensin converting enzyme inhibitors, including enalapril maleate, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. Enalapril maleate should be promptly discontinued and appr...
The following adverse reactions are described elsewhere: Angioedema [see Warnings and Precautions ( 5.2 )] Hypotension [see Warnings and Precautions ( 5.3 )] Hepatic failure [see Warnings and Precautions ( 5.4 )] Renal impairment [see Warnings and Precautions ( 5.5 )] Hyperkalemia [see Warnings and Precautions ( 5.6 )] The most common adverse reaction for patients treated for hypertension (≥3%) was fatigue ( 6.1 ). The most common adverse reactions for patients treated for heart failure (>6%) were hypotension and dizziness ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc. at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Enalapril has been evaluated for safety in more than 10,000 patients, including over 1,000 patients treated for one year or more. In clinical trials, discontinuation of therapy for clinical adverse experiences was re...
Source: FDA SPL label for Enalapril maleate (Wilshire Pharmaceuticals, Inc.), effective 20251216. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 4,497 | 3,760 | 3,017 | 2,391 | 2,441 | 2,037 | 1,850 | 895 |
2,303 reports blaming this drug for every million Medicare prescriptions filled, which is 0.8× the typical drug on this site. (4,611 reports in 2024–2026, against 2,002,117 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 04/2026 | Class II | JB Chemicals and Pharmaceuticals Ltd | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test |
| 03/2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviations |
| 03/2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviations |
| 03/2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviations |
| 03/2022 | Class II | Golden State Medical Supply Inc. | CGMP Deviations |
| 05/2014 | Class III | Valeant Pharmaceuticals North America LLC | Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Enalapril Maleate | 2,000,801 | $17 |
| Vasotec | 1,253 | $2,609 |
| Epaned | 63 | $1,392 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.