Prescription medicine
Lisinopril Brand names: Zestril, Qbrelis; first approved as Prinivil
Lisinopril (Zestril) is a prescription medicine with an FDA approval on record since 1987. FDA's NDC Directory lists it from 36 generic labelers, and pharmacies paid $0.0254 per lisinopril 20 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $4.50 per mL (Qbrelis 1 mg/mL solution).
- Generic listed
- Boxed warning
Check it at the source: the lisinopril FDA label on DailyMed (effective January 2, 2025, Upsher-Smith Laboratories, LLC); the NDA 19558 record on Drugs@FDA; every lisinopril label on DailyMed.
Highlights of the record
FDA label of January 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue ZESTRIL 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 Zestril as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageZestril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 Hypertension Zestril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
- 30 mg
- 40 mg
- 1 mg/ml
Tablet; solution.
On the market
- Earliest approval on file
- December 29, 1987 Prinivil, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first July 1, 2002; 14 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 38 of which 36 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- November 6, 2035 Qbrelis oral solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0254 per tablet Lisinopril 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 28 since 2012 0 Class I among all firms' recalls; latest November 15, 2024; 4 more by firms not listed as its makers
- FAERS reports
- 304,309 through July 30, 2026
What is lisinopril used for?
From the label: indications and usageZestril is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 Hypertension Zestril is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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. […]
Conditions named in the indications of lisinopril's FDA labels, with every medicine labeled for each:
From other lisinopril labelsHeart failure: Zestril is indicated to reduce signs and symptoms of systolic heart failure [see Clinical Studies (14.2) ].
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor.
Source: FDA drug label (Zestril), NDA019777 (Twi Pharms), as published by Upsher-Smith Laboratories, LLC, effective January 2, 2025 (SPL set 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8), via openFDA; the full label on DailyMed
Is there a generic for lisinopril (Zestril)?
The FDA approved the first generic lisinopril on July 1, 2002. 20 generic applications are approved; 14 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 lisinopril from 36 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zestril tablets; a patent listed only for Qbrelis oral solution runs to November 6, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1987 earliest approval on file
- 2002 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for lisinopril (Zestril)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0254 per Lisinopril 20 mg tablet, down 3% from $0.0262 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Lisinopril 20 mg tablet (generic)
- Qbrelis 1 mg/mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lisinopril 10 mg tablet | Generic | $0.0181 per tablet | $0.544 | -1% |
| Lisinopril 2.5 mg tablet | Generic | $0.014 per tablet | $0.421 | -2% |
| Lisinopril 20 mg tablet | Generic | $0.0254 per tablet | $0.761 | -3% |
| Lisinopril 30 mg tablet | Generic | $0.052 per tablet | $1.56 | -4% |
| Lisinopril 40 mg tablet | Generic | $0.0462 per tablet | $1.39 | -1% |
| Lisinopril 5 mg tablet | Generic | $0.0143 per tablet | $0.430 | -4% |
| Qbrelis 1 mg/mL solution | Brand | $4.50 per mL | n/a | +3% |
| Zestril 10 mg tablet | Brand | $12.52 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $375.73 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has lisinopril been recalled?
The FDA's Enforcement Report lists 32 recalls naming lisinopril since 2012: 0 Class I (the most serious), 26 Class II, 6 Class III; 1 still ongoing. 4 of them are by firms that FDA's NDC Directory does not list as a maker of lisinopril and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 15, 2024 | Class II | Evaric Pharmaceuticals Inc. | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. |
| October 27, 2023 | Class III | NCS Healthcare of Kentucky Inc | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots |
| September 15, 2022 | Class II | RemedyRepack Inc. | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. |
| September 13, 2022 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. |
| July 17, 2020 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg |
| May 28, 2020 | Class II | Lupin Pharmaceuticals Inc. | Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. |
| April 20, 2020 | Class II | Lupin Pharmaceuticals Inc. | Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles. |
| April 1, 2020 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the lisinopril label say about other medicines?
The lisinopril label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name lisinopril. 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 |
|---|---|---|
| Aliskiren | contraindications | Zestril is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema Do not co-administer aliskiren with ZESTRIL in patients with diabetes [see Drug Interactions (7.4) ]. |
| Amiloride | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
| Everolimus | drug interactions | 7.7 mTOR Inhibitor s Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. [ see Warnings and Precautions (5.2) ] |
| Lithium | drug interactions | Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.5 ) Gold: |
| Losartan | drug interactions | The VA NEPHRON trial enrolled 1,448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 mL/min 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. |
| Sacubitril and valsartan | contraindications | Do not administer Zestril within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [ see Warnings and Precautions (5.2)]. |
| Sirolimus | drug interactions | 7.7 mTOR Inhibitor s Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. [ see Warnings and Precautions (5.2) ] |
| Spironolactone | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
| Temsirolimus | drug interactions | 7.7 mTOR Inhibitor s Patients taking concomitant mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema. [ see Warnings and Precautions (5.2) ] |
| Triamterene | drug interactions | Potassium-sparing diuretics (spironolactone, amiloride, triamterene, and others) can increase the risk of hyperkalemia. |
Other labels that name lisinopril
Source: FDA drug label (Zestril), NDA019777 (Twi Pharms), as published by Upsher-Smith Laboratories, LLC, effective January 2, 2025 (SPL set 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8), via openFDA; the full label on DailyMed
What do FAERS reports show for lisinopril?
The FDA Adverse Event Reporting System holds 304,309 reports that list lisinopril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25,263 are coded as a death and 97,537 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.
Reports received each year
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 lisinopril?
78 other medicines are given the same way (oral) and in the same FDA class as lisinopril 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. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Enalapril | High blood pressure, Heart failure | 29 labelers | $0.0664 per tablet 10 mg tablet | No current entry |
| Amlodipine and benazepril | High blood pressure | 16 labelers | $0.114 per unit 10-20 mg | No current entry |
| Benazepril | High blood pressure | 21 labelers | $0.0789 per tablet 20 mg tablet | No current entry |
| Ramipril | High blood pressure, Heart attack and coronary artery disease | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure, Heart failure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure, Heart failure | 9 labelers | n/a | In shortage |
| Fosinopril | High blood pressure, Heart failure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Benazepril and hydrochlorothiazide | High blood pressure | 3 labelers | $0.222 per tablet 20-12.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as lisinopril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does lisinopril compare with medicines for the same use?
32 side-by-side pages set lisinopril beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
- Amlodipine
- Atenolol
- Atorvastatin
- Benazepril
- Bisoprolol
- Candesartan
- Captopril
- Carvedilol
- Chlorthalidone
- Clonidine
- Diltiazem
- Enalapril
- Fosinopril
- Guanfacine
- Hydrochlorothiazide
- Irbesartan
- Labetalol
- Losartan
- Metoprolol
- Minoxidil
- Nebivolol
- Nifedipine
- Olmesartan
- Propranolol
- Quinapril
- Ramipril
- Rosuvastatin
- Spironolactone
- Telmisartan
- Trandolapril
- Valsartan
- Verapamil
What next?
- Alternatives to lisinopril
- 78 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Lisinopril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other