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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.

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 →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

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

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.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for lisinopril each year to the FDA Adverse Event Reporting System (FAERS).

-10,000010,00020,00030,000 200120052008201120142017202020232025 13,193

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.

fewest reports most reports

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

Female 145,314 (52%)
Male 134,986 (48%)

Age Distribution

0–17 1,869
18–44 17,385
45–64 81,105
65–74 53,342
75+ 43,583

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

DEATH 8,144
COMPLETED SUICIDE 2,989
FATIGUE 1,605
DYSPNOEA 1,581
PAIN 1,523
PNEUMONIA 1,511
RENAL FAILURE 1,440
DIARRHOEA 1,409
VOMITING 1,338
HYPERTENSION 1,317

Reactions in Hospitalization Reports

DYSPNOEA 6,853
NAUSEA 6,491
DIARRHOEA 5,952
FATIGUE 5,829
PNEUMONIA 5,737
VOMITING 5,604
ASTHENIA 5,266
FALL 5,228
ACUTE KIDNEY INJURY 4,895
PAIN 4,774

Source: FDA FAERS (Adverse Event Reporting System) 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.

What to do: Your healthcare provider should regularly check your blood pressure, kidney function, and salt levels while you are on both medications.

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.

What to do: This combination should be avoided, especially if you have diabetes or kidney issues, to prevent serious health risks.

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.

What to do: This combination is usually avoided because it increases the risk of kidney injury without providing extra health benefits.

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.

What to do: Your healthcare provider should regularly check your potassium levels to ensure they stay within a safe range.

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.

What to do: No special changes are usually needed when these two medicines are used at the same time.

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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

Common Questions

What are the common side effects of lisinopril?
The most commonly reported side effects of lisinopril include Dizziness, Headache, Cough, Feeling tired, Diarrhea. Based on 297,692 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does lisinopril interact with other medications?
Yes, lisinopril has 15 known drug interactions. Notable interactions include hydrochlorothiazide, aliskiren, losartan. Always inform your doctor about all medications you are taking.
What drug class is lisinopril?
lisinopril belongs to the ACE Inhibitor drug class. It requires a prescription (Rx).
Is there a generic version of lisinopril?
Yes, generic lisinopril is available from 16 manufacturers. The generic costs $0.02 per unit compared to $12.67 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Has lisinopril been recalled?
There is 1 recall associated with lisinopril products. Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12. Check the recalls section below for full details and affected products.

Active Recalls

Class II June 20, 2025

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.

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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: June 29, 2023

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page