Prescription medicine
Enalaprilat First approved as Vasotec
Enalaprilat (Vasotec) is a prescription medicine with an FDA approval on record since 1988. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the enalaprilat FDA label on DailyMed (effective June 7, 2024, Dr. Reddys Laboratories Inc); the NDA 19309 record on Drugs@FDA; every enalaprilat label on DailyMed.
Highlights of the record
FDA label of June 7, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
IN PREGNANCY.
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalaprilat injection should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
Used for
From the label: indications and usageEnalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical.
Forms and strengths
- 1.25 mg/ml
- 2.5 mg/2ml
Injection.
On the market
- Earliest approval on file
- February 9, 1988 Vasotec, Biovail Labs Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first August 22, 2000; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 250 through July 30, 2026
What is enalaprilat used for?
From the label: indications and usageEnalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure. Enalapril, the pro-drug of enalaprilat, has been used extensively with a variety of other antihypertensive agents, without apparent difficulty except for occasional hypotension. […]
Conditions named in the indications of enalaprilat's FDA labels, with every medicine labeled for each:
From other enalaprilat labelsHigh blood pressure: INDICATIONS AND USAGE Enalaprilat injection is indicated for the treatment of hypertension when oral therapy is not practical.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Enalaprilat), Dr. Reddys Laboratories Inc, effective June 7, 2024 (SPL set 5d398da1-020c-ccb1-a775-ce8e0b29d621), via openFDA; the full label on DailyMed
Is there a generic for enalaprilat (Vasotec)?
The FDA approved the first generic enalaprilat on August 22, 2000. 6 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists enalaprilat from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1988 earliest approval on file
- 2000 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the enalaprilat label say about other medicines?
The enalaprilat label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name enalaprilat. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiloride | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
| Captopril | warnings | Neutropenia/Agranulocytosis Another angiotensin-converting enzyme inhibitor, captopril, has been shown to cause agranulocytosis and bone marrow depression, rarely in uncomplicated patients but more frequently in patients with renal impairment especially if they also have a collagen vascular disease. |
| Enalapril | drug interactions | Non-Steroidal Anti-Inflammatory Agents: In some patients with compromised renal function who are being treated with non-steroidal anti-inflammatory drugs, the coadministration of enalapril may result in a further deterioration of renal function. |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided (see ADVERSE REACTIONS ). |
| Hydralazine | drug interactions | Other Cardiovascular Agents: Enalaprilat injection has been used concomitantly with digitalis, beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine and prazosin without evidence of clinically significant adverse interactions. |
| Indomethacin | drug interactions | In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving enalapril maleate. |
| Lithium | drug interactions | Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. |
| Methyldopa | drug interactions | Other Cardiovascular Agents: Enalaprilat injection has been used concomitantly with digitalis, beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine and prazosin without evidence of clinically significant adverse interactions. |
| Prazosin | drug interactions | Other Cardiovascular Agents: Enalaprilat injection has been used concomitantly with digitalis, beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine and prazosin without evidence of clinically significant adverse interactions. |
| Spironolactone | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
| Sulindac | drug interactions | In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving enalapril maleate. |
| Triamterene | drug interactions | Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. |
Other labels that name enalaprilat
Source: FDA drug label (Enalaprilat), Dr. Reddys Laboratories Inc, effective June 7, 2024 (SPL set 5d398da1-020c-ccb1-a775-ce8e0b29d621), via openFDA; the full label on DailyMed
What do FAERS reports show for enalaprilat?
The FDA Adverse Event Reporting System holds 250 reports that list enalaprilat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 113 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as enalaprilat?
4 other medicines are given the same way (intravenous) and in the same FDA class as enalaprilat or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Esmolol | High blood pressure | 12 labelers | n/a | No current entry |
| Nicardipine | High blood pressure | 16 labelers | n/a | No current entry |
| Labetalol | High blood pressure | 15 labelers | $0.185 per mL 100 mg/20 mL vial | No current entry |
| Metoprolol | High blood pressure | 14 labelers | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as enalaprilat
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to enalaprilat
- 4 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Enalaprilat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other