Prescription medication · ACE Inhibitor
lisinopril
Also sold as Prinivil, Zestril.
Data updated 2026-05-15
- 297,692
- FDA reportsHeavily reported
- 15
- InteractionsSeveral interactions
- 99% less
- Generic vs brandHuge savings
- 1
- Recall record
What the data shows
lisinopril (Prinivil) is a prescription ACE Inhibitor, in the top 5% of tracked drugs by FAERS report volume (297,692 FDA reports), whose generic costs a fraction of the brand (about 99% less).
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.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$12.67/unit
Generic Price
$0.02/unit
Generic Savings
99%
Generic Available
Yes (16 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: LISINOPRIL 10 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -5.4% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| October 23, 2024 | $0.0181/EA | - | 2 |
| December 18, 2024 | $0.0171/EA | -5.4% | 33 |
What it does
Information not available.
Common side effects
Dizziness, Headache, Cough
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 297,692 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for lisinopril, by number of reports
- Fatigue
Fatigue
19,346 reports
- Nausea
Nausea
17,996 reports
- Diarrhoea
Diarrhoea
16,771 reports
- Dyspnoea
Dyspnoea
13,650 reports
- Pain
Pain
13,303 reports
- Dizziness
Dizziness
13,194 reports
- Headache
Headache
12,600 reports
- Asthenia
Asthenia
10,668 reports
- Vomiting
Vomiting
10,619 reports
- Acute Kidney Injury
Acute Kidney Injury
9,385 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 lisinopril 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 lisinopril sits
lisinopril has more FDA adverse-event reports than 97% 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 lisinopril; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 297,692 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.
Total Reports
297,692
Reports Mentioning Death
24,562
8.3% of reports — not proof of cause
Hospitalization Reports
95,486
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 19,346 |
| 2 | NAUSEA | 17,996 |
| 4 | DIARRHOEA | 16,771 |
| 5 | DYSPNOEA | 13,650 |
| 6 | PAIN | 13,303 |
| 7 | DIZZINESS | 13,194 |
| 8 | HEADACHE | 12,600 |
| 9 | ASTHENIA | 10,668 |
| 10 | VOMITING | 10,619 |
| 12 | ACUTE KIDNEY INJURY | 9,385 |
| 13 | ARTHRALGIA | 9,325 |
| 14 | CHRONIC KIDNEY DISEASE | 9,109 |
| 15 | FALL | 8,899 |
| 16 | HYPERTENSION | 8,529 |
| 17 | RASH | 8,289 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Monitor blood pressure, renal function, and electrolytes in patients on lisinopril and hydrochlorothiazide tablets and other agents that affect the RAS. Do not coadminister aliskiren with lisinopril and hydrochlorothiazide tablets in patients with diabetes. No meaningful clinically important pharmacokinetic interactions occurred when lisinopril was used concomitantly with propranolol, digoxin, or hydrochlorothiazide.
Mechanism: These drugs work in different ways to lower blood pressure and do not interfere with how the body breaks each other down.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or direct renin inhibitors (such as aliskiren) is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with lisinopril and hydrochlorothiazide tablets in patients with diabetes. Avoid use of aliskiren with PRINZIDE in patients with renal impairment (GFR <60 ml/min).
Mechanism: Both medicines target the same body system to lower blood pressure, which can lead to dangerously low blood pressure or kidney damage.
The VA NEPHRON trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end state renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury...
Mechanism: Using these two blood pressure drugs together can overwork the kidneys and cause potassium to build up to unsafe levels.
Use of lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium.
Mechanism: Both drugs prevent the kidneys from removing potassium, which can cause this mineral to build up in your blood.
No meaningful clinically important pharmacokinetic interactions occurred when lisinopril was used concomitantly with propranolol, digoxin, or hydrochlorothiazide.
Mechanism: These drugs do not change how the body absorbs or breaks down one another.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of lisinopril?
Does lisinopril interact with other medications?
What drug class is lisinopril?
Is there a generic version of lisinopril?
Has lisinopril been recalled?
Active Recalls
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Lupin Pharmaceuticals Inc.
Related Medications in ACE Inhibitor
Other drugs grouped near lisinopril - same-class peers and common alternatives.
acebutolol
Sectral
Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.
Compare with lisinopril →
aliskiren
Tekturna
Tekturna is a medicine used to treat high blood pressure.
Compare with lisinopril →
amiloride
Midamor
Amiloride is a water pill that helps your body hold onto potassium.
Compare with lisinopril →
amlodipine
Norvasc
Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.
Compare with lisinopril →
amlodipine/benazepril
Lotrel
Lotrel is a combination medicine that contains amlodipine and benazepril.
Compare with lisinopril →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for lisinopril: 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: 297,692.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 8.25%.
- leflunomide Δ 0.03 pts · 102,095 reports · Disease-Modifying Antirheumatic Drug (DMARD) 8.28%death share
- levomilnacipran Δ 0.04 pts · 1,858 reports · Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) 8.29%death share
- lithium Δ 0.04 pts · 24,367 reports · Mood Stabilizer 8.29%death share
- acarbose Δ 0.05 pts · 3,736 reports · Alpha-Glucosidase Inhibitor 8.30%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 lisinopril
The FDA label for lisinopril (sold under brand names such as Prinivil, Zestril) classifies it as a prescription-only medication in the ACE Inhibitor class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 6 commonly reported side effects, including Dizziness, Headache, Cough.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 297,692 voluntary reports. The database also lists 15 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 $0.02 versus $12.67 for the brand - a 99% generic savings.
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 1 recall record 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: June 29, 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