Prescription medicine
Hydrochlorothiazide and lisinopril Brand names: Zestoretic; first approved as Prinzide
Hydrochlorothiazide and lisinopril (Zestoretic) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.0293 per lisinopril-hydrochlorothiazide 10-12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the hydrochlorothiazide and lisinopril FDA label on DailyMed (effective March 31, 2025, Almatica Pharma Inc.); the NDA 19778 record on Drugs@FDA; every hydrochlorothiazide and lisinopril label on DailyMed.
Highlights of the record
FDA label of March 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ZESTORETIC as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See Warnings: Fetal Toxicity.
Used for
From the label: indications and usageZESTORETIC is indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 10 mg / 12.5 mg
- 12.5 mg / 10 mg
- 12.5 mg / 20 mg
- 20 mg / 12.5 mg
- 20 mg / 25 mg
- 25 mg / 20 mg
Tablet.
On the market
- Earliest approval on file
- February 16, 1989 Prinzide, Merck; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first July 1, 2002; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0293 per tablet Lisinopril-hydrochlorothiazide 10-12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2012 0 Class I among all firms' recalls; latest June 20, 2025
- FAERS reports
- 10,178 through July 30, 2026
What is hydrochlorothiazide and lisinopril used for?
From the label: indications and usageZESTORETIC is indicated for the treatment of hypertension, 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 including lisinopril and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. […]
Conditions named in the indications of hydrochlorothiazide and lisinopril's FDA labels, with every medicine labeled for each:
From other hydrochlorothiazide and lisinopril labelsHigh blood pressure: INDICATIONS AND USAGE ZESTORETIC is indicated for the treatment of hypertension, to lower blood pressure.
FDA pharmacologic class: Angiotensin Converting Enzyme Inhibitor and Thiazide Diuretic.
Source: FDA drug label (Zestoretic), Almatica Pharma Inc., effective March 31, 2025 (SPL set 0d3a966f-f937-05a8-a90f-5aa52ebbd613), via openFDA; the full label on DailyMed
Is there a generic for hydrochlorothiazide and lisinopril (Zestoretic)?
The FDA approved the first generic hydrochlorothiazide and lisinopril on July 1, 2002. 13 generic applications are approved; 8 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 hydrochlorothiazide and lisinopril from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 2002 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for hydrochlorothiazide and lisinopril (Zestoretic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0293 per Lisinopril-hydrochlorothiazide 10-12.5 mg tablet, down 2% from $0.0298 on October 8, 2025. 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-hydrochlorothiazide 10-12.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Lisinopril-hydrochlorothiazide 10-12.5 mg tablet | Generic | $0.0293 per tablet | $0.880 | -2% |
| Lisinopril-hydrochlorothiazide 20-12.5 mg tablet | Generic | $0.0361 per tablet | $1.08 | -10% |
| Lisinopril-hydrochlorothiazide 20-25 mg tablet | Generic | $0.0408 per tablet | $1.23 | -3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has hydrochlorothiazide and lisinopril been recalled?
The FDA's Enforcement Report lists 7 recalls naming hydrochlorothiazide and lisinopril since 2012: 0 Class I (the most serious), 6 Class II, 1 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 20, 2025 | Class II | Lupin Pharmaceuticals Inc. | 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 … |
| January 26, 2022 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| August 5, 2019 | Class II | RemedyRepack Inc. | Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed … |
| July 19, 2019 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle. |
| July 17, 2019 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the … |
| April 4, 2016 | Class III | Lupin Pharmaceuticals Inc. | CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. |
| November 30, 2012 | Class II | West-ward Pharmaceutical Corp. | Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the hydrochlorothiazide and lisinopril label say about other medicines?
The hydrochlorothiazide and lisinopril label names 17 other medicines in its interaction, contraindication or warning sections. 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 | Do not co-administer aliskiren with ZESTORETIC in patients with diabetes (see PRECAUTIONS, Drug Interactions ). |
| Amiloride | drug interactions | 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. |
| Captopril | warnings | Leukopenia/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. |
| Cholestyramine | drug interactions | Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Colestipol | drug interactions | Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. |
| Digoxin | drug interactions | Other Agents: Lisinopril has been used concomitantly with nitrates and/or digoxin without evidence of clinically significant adverse interactions. |
| Epinephrine | warnings | Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, 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 ). |
| Eplerenone | drug interactions | 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. |
| Everolimus | drug interactions | … inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS ). |
| Lithium | drug interactions | Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. |
| Losartan | drug interactions | 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 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. |
| Propranolol | drug interactions | No meaningful clinically important pharmacokinetic interactions occurred when lisinopril was used concomitantly with propranolol, digoxin, or hydrochlorothiazide. |
| Sacubitril and valsartan | contraindications | Do not administer ZESTORETIC within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS ). |
| Sirolimus | drug interactions | It is recommended that serum lithium levels be monitored frequently if lisinopril is administered concomitantly with lithium. mTOR (mammalian target of rapamycin) inhibitors Patients receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased … |
Every other medicine the hydrochlorothiazide and lisinopril label names
| Medicine named | Section | What the label says |
|---|---|---|
| Spironolactone | drug interactions | Use of lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to … |
| Temsirolimus | drug interactions | … receiving coadministration of ACE inhibitor and mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema (see WARNINGS ). |
| Triamterene | drug interactions | Use of lisinopril with potassium-sparing diuretics (e.g., spironolactone, eplerenone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to … |
Check hydrochlorothiazide and lisinopril against other medicines
Source: FDA drug label (Zestoretic), Almatica Pharma Inc., effective March 31, 2025 (SPL set 0d3a966f-f937-05a8-a90f-5aa52ebbd613), via openFDA; the full label on DailyMed
What do FAERS reports show for hydrochlorothiazide and lisinopril?
The FDA Adverse Event Reporting System holds 10,178 reports that list hydrochlorothiazide and lisinopril among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 595 are coded as a death and 3,301 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 hydrochlorothiazide and lisinopril?
56 other medicines are given the same way (oral) and in the same FDA class as hydrochlorothiazide and 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 | 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 | 17 labelers | $0.0707 per capsule 10 mg capsule | No current entry |
| Captopril | High blood pressure | 13 labelers | $0.228 per tablet 12.5 mg tablet | No current entry |
| Quinapril | High blood pressure | 9 labelers | n/a | In shortage |
| Fosinopril | High blood pressure | 7 labelers | $0.154 per tablet 10 mg tablet | No current entry |
| Trandolapril | High blood pressure | 5 labelers | $0.157 per tablet 1 mg tablet | No current entry |
Every medicine labeled for the same conditions as hydrochlorothiazide and lisinopril
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to hydrochlorothiazide and lisinopril
- 56 medicines for the same use
- Other ACE inhibitors
- the pharmacologic class, with prices and generics
- Hydrochlorothiazide and lisinopril side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other