Prescription medication · ACE Inhibitor
enalapril
Also sold as Vasotec. Enalapril is used to treat high blood pressure.
Data updated 2026-05-15
- 54,355
- FDA reportsOften reported
- 16
- InteractionsSeveral interactions
- 4
- Recall records
What the data shows
enalapril (Vasotec) is a prescription ACE Inhibitor, reported at a middle-of-the-pack volume (54,355 FDA reports), with 16 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
enalapril (Vasotec) is a prescription ACE Inhibitor. Enalapril is used to treat high blood pressure.
Enalapril (Vasotec) is a medicine that lowers blood pressure and helps treat heart failure. It belongs to a class of drugs called ACE inhibitors.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$1.33/unit
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Enalapril is used to treat high blood pressure.
Common side effects
Headache, Dizziness, Fatigue
Key warnings
This drug can harm your unborn baby.
The sections below are summarized in plain English from enalapril's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Enalapril blocks a substance in your body that tightens blood vessels. This helps your blood vessels relax and widens them. As a result, blood pressure is lowered, and blood can flow more easily.
Side Effects (from patient reports)
Based on 54,355 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for enalapril, by number of reports
- Diarrhoea
Diarrhoea
2,807 reports
- Dyspnoea
Dyspnoea
2,659 reports
- Nausea
Nausea
2,574 reports
- Fatigue
Fatigue
2,377 reports
- Drug Interaction
Drug Interaction
2,336 reports
- Dizziness
Dizziness
2,213 reports
- Acute Kidney Injury
Acute Kidney Injury
2,007 reports
- Vomiting
Vomiting
1,988 reports
- Headache
Headache
1,819 reports
- Pain
Pain
1,805 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for enalapril each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where enalapril sits
enalapril has more FDA adverse-event reports than 74% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is enalapril; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 54,355 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
54,355
Reports Mentioning Death
5,908
10.9% of reports — not proof of cause
Hospitalization Reports
26,280
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DIARRHOEA | 2,807 |
| 2 | DYSPNOEA | 2,659 |
| 3 | NAUSEA | 2,574 |
| 5 | FATIGUE | 2,377 |
| 6 | DRUG INTERACTION | 2,336 |
| 7 | DIZZINESS | 2,213 |
| 8 | ACUTE KIDNEY INJURY | 2,007 |
| 9 | VOMITING | 1,988 |
| 10 | HEADACHE | 1,819 |
| 11 | PAIN | 1,805 |
| 12 | ASTHENIA | 1,755 |
| 13 | HYPERTENSION | 1,695 |
| 15 | MALAISE | 1,673 |
| 16 | HYPOTENSION | 1,668 |
| 17 | FALL | 1,570 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This drug can harm your unborn baby. Stop taking enalapril as soon as you know you are pregnant.
Known Drug Interactions
Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with enalapril maleate in patients with diabetes. Avoid use of aliskiren with enalapril maleate in patients with renal impairment (GFR <60 mL/min).
Mechanism: Both drugs work on the same system to lower blood pressure, which can lead to dangerously low blood pressure or kidney damage.
Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Mechanism: Both of these medications can cause your body to hold onto potassium instead of flushing it out. This can lead to dangerously high levels of potassium in your blood.
Other Cardiovascular Agents Enalapril maleate has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions.
Mechanism: These two blood pressure medicines work in different ways to relax your blood vessels and have not been shown to cause harmful interactions when used together.
Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. A few cases of lithium toxicity have been reported in patients receiving concomitant enalapril maleate and lithium and were reversible upon discontinuation of both drugs. It is recommended that serum lithium levels be monitored frequently if enalapril is administered concomitantly with lithium.
Mechanism: Enalapril can cause your body to lose sodium, which makes it harder for your kidneys to get rid of lithium. This can cause lithium to build up to toxic levels in your blood.
Other Cardiovascular Agents Enalapril maleate has been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions.
Mechanism: Both drugs are used to lower blood pressure, but studies show they do not cause harmful interactions when taken together.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take enalapril with other medications?
What should I do if I feel dizzy after taking enalapril?
Can I drink alcohol while taking enalapril?
How long does it take for enalapril to start working?
Can I stop taking enalapril if I feel better?
Does enalapril affect my kidneys?
Can enalapril cause a cough?
Are there any foods I should avoid while taking enalapril?
What if I have swelling in my face, tongue, or throat?
Can I take enalapril if I have diabetes?
What are the common side effects of enalapril?
Does enalapril interact with other medications?
What drug class is enalapril?
What pregnancy or breastfeeding source fields are listed for enalapril?
Has enalapril been recalled?
Active Recalls
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
JB Chemicals and Pharmaceuticals Ltd
CGMP Deviations
Golden State Medical Supply Inc.
CGMP Deviations
Golden State Medical Supply Inc.
CGMP Deviations
Golden State Medical Supply Inc.
Related Medications in ACE Inhibitor
Other drugs grouped near enalapril - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with enalapril →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with enalapril →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with enalapril →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with enalapril →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with enalapril →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for enalapril: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 54,355.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 10.87%.
- hydroxychloroquine Δ 0.00 pts · 71,900 reports · Disease-Modifying Antirheumatic Drug (DMARD) 10.87%death share
- ramelteon Δ 0.00 pts · 7,215 reports · Melatonin Receptor Agonist 10.87%death share
- nateglinide Δ 0.04 pts · 1,302 reports · Meglitinide 10.83%death share
- fidaxomicin Δ 0.04 pts · 2,273 reports · Macrocyclic Antibiotic 10.91%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for enalapril
The FDA label for enalapril (sold under brand names such as Vasotec) classifies it as a prescription-only medication in the ACE Inhibitor class. Enalapril is used to treat high blood pressure. Official labeling lists 4 commonly reported side effects, including Headache, Dizziness, Fatigue.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 54,355 voluntary reports. The database also lists 16 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.33.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 9, 2023
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages