Quinapril HCL and hydrochlorothiazide

What Quinapril HCL and hydrochlorothiazide is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Hypertension: Quinapril and Hydrochlorothiazide Tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. …

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, oral), Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc.; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Related medical specialties

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY. Read it on the full label →

4 of 4 FDA labels for this medicine have a boxed warning.

Quinapril HCL and hydrochlorothiazide boxed warning: what the label says

Quoted from the boxed warning of the FDA-approved label.

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Quinapril and Hydrochlorothiazide Tablets 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

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. Read the full label on DailyMed →

Quinapril HCL and hydrochlorothiazide side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

Quinapril and Hydrochlorothiazide Tablets has been evaluated for safety in 1571 patients in controlled and uncontrolled studies. Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years. In clinical trials with Quinapril and Hydrochlorothiazide Tablets, no adverse experience specific to the combination has been observed.

Read more of this section

Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide. Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies. The most common reasons for discontinuation of therapy with Quinapril and Hydrochlorothiazide Tablets were cough (1.0%; see PRECAUTIONS) and headache (0.7%). Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials are shown below. Percent of Patients in Controlled Trials Quinapril/HCTZ N = 943 Placebo N = 100 Headache 6.7 30.0 Dizziness 4.8 4.0 Coughing 3.2 2.0 Fatigue 2.9 3.0 Myalgia 2.4 5.0 Viral Infection 1.9 4.0 Rhinitis 2.0 3.0 Nausea and/or Vomiting 1.8 6.0 Abdominal Pain 1.7 4.0 Back Pain 1.5 2.0 Diarrhea 1.4 1.0 Upper Respiratory Infection 1.3 4.0 Insomnia 1.2 2.0 Somnolence 1.2 0.0 Bronchitis 1.2 1.0 Dyspepsia 1.2 2.0 Asthenia 1.1 1.0 Pharyngitis 1.1 2.0 Vasodilatation 1.0 1.0 Vertigo 1.0 2.0 Chest Pain 1.0 2.0 Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥0.5% to <1.0% (except as noted) of the patients treated with quinapril/HCTZ in controlled and uncontrolled trials (N=1571) and less frequent, clinically significant events seen in clinical trials or postmarketing experience (the rarer events are in italics) include (listed by body system): BODY AS A WHOLE: Asthenia, Malaise CARDIOVASCULAR: Palpitation, Tachycardia, Heart Failure, Hyperkalemia, Myocardial Infarction, Cerebrovascular Accident, Hypertensive Crisis, Angina Pectoris, Orthostatic Hypotension, Cardiac Rhythm Disturbance GASTROINTESTINAL: Mouth or Throat Dry, Gastrointestinal Hemorrhage, Pancreatitis, Abnormal Liver Function Tests NERVOUS/PSYCHIATRIC: Nervousness, Vertigo, Paresthesia RESPIRATORY: Sinusitis, Dyspnea INTEGUMENTARY: Pruritus, Sweating Increased, Erythema Multiforme, Exfoliative Dermatitis, Photosensitivity Reaction, Alopecia, Pemphigus UROGENITAL SYSTEM: Acute Renal Failure, Impotence OTHER: Agranulocytosis, Thrombocytopenia, Arthralgia Angioedema: Angioedema has been reported in 0.1% of patients receiving quinapril (0.1%) (see WARNINGS).

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. This is part of the section. Read the full label on DailyMed →

Quinapril HCL and hydrochlorothiazide dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

As individual monotherapy, quinapril is an effective treatment of hypertension in once- daily doses of 10 to 80 mg and hydrochlorothiazide is effective in doses of 12.5 to 50 mg. In clinical trials of quinapril/hydrochlorothiazide combination therapy using quinapril doses of 2.5 to 40 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing dose of either component.

Read more of this section

The side effects (see WARNINGS) of quinapril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of quinapril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but regimens that combine low doses of hydrochlorothiazide with quinapril produce minimal effects on serum potassium. In clinical trials of Quinapril and Hydrochlorothiazide Tablets, the average change in serum potassium was near zero in subjects who received HCTZ 6.25 mg in the combination, and the average subject who received 10 to 40/12.5 to 25 mg experienced a milder reduction in serum potassium than that experienced by the average subject receiving the same dose of hydrochlorothiazide monotherapy. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. Therapy Guided by Clinical Effect Patients whose blood pressures are not adequately controlled with quinapril monotherapy may instead be given Quinapril and Hydrochlorothiazide Tablets 10/12.5 or 20/12.5. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve blood pressure control with less electrolyte disturbance if they are switched to Quinapril and Hydrochlorothiazide Tablets 10/12.5 or 20/12.5. Replacement Therapy For convenience, patients who are adequately treated with 20 mg of quinapril and 25 mg of hydrochlorothiazide and experience no significant electrolyte disturbances may instead wish to receive Quinapril and Hydrochlorothiazide Tablets 20/25. Use in Renal Impairment Regimens of therapy with Quinapril and Hydrochlorothiazide Tablets need not take account of renal function as long as the patient's creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides. Therefore, Quinapril and Hydrochlorothiazide Tablets is not recommended for use in these patients

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. Read the full label on DailyMed →

When Quinapril HCL and hydrochlorothiazide should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

Quinapril and Hydrochlorothiazide Tablets are contraindicated in patients who are hypersensitive to quinapril or hydrochlorothiazide and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril and Hydrochlorothiazide Tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).

Read more of this section

Do not administer Quinapril and Hydrochlorothiazide Tablets within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS and PRECAUTIONS). Because of the hydrochlorothiazide components, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer Quinapril and Hydrochlorothiazide Tablets with aliskiren: in patients with diabetes. in patients with diabetes

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. Read the full label on DailyMed →

Quinapril HCL and hydrochlorothiazide overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

No specific information is available on the treatment of overdosage with Quinapril and Hydrochlorothiazide Tablets or quinapril monotherapy; treatment should be symptomatic and supportive. Therapy with Quinapril and Hydrochlorothiazide Tablets should be discontinued, and the patient should be observed. Dehydration, electrolyte imbalance, and hypotension should be treated by established procedures.

Read more of this section

The oral median lethal dose of quinapril/hydrochlorothiazide in combination ranges from 1063/664 to 4640/2896 mg/kg in mice and rats. Doses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. In single-dose studies of hydrochlorothiazide, most rats survived doses up to 2.75 g/kg. Data from human overdoses of ACE inhibitors are scanty; the most likely manifestation of human quinapril overdosage is hypotension. In human hydrochlorothiazide overdose, the most common signs and symptoms observed have been those of dehydration and electrolyte depletion (hypokalemia, hypochloremia, hyponatremia). If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. Laboratory determinations of serum levels of quinapril and its metabolites are not widely available, and such determinations have, in any event, no established role in the management of quinapril overdose. No data are available to suggest physiological maneuvers (e.g., maneuvers to change the pH of the urine) that might accelerate elimination of quinapril and its metabolites. Hemodialysis and peritoneal dialysis have little effect on the elimination of quinapril and quinaprilat. Angiotensin II could presumably serve as a specific antagonist-antidote in the setting of quinapril overdose, but angiotensin II is essentially unavailable outside of scattered research facilities. Because the hypotensive effect of quinapril is achieved through vasodilation and effective hypovolemia, it is reasonable to treat quinapril overdose by infusion of normal saline solution

— FDA label: Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

Other medicines with one of these active ingredients

• HydrochlorothiazideInzirqo · 171 products
• Losartan potassium and hydrochlorothiazideHyzaar · 111 products
• Valsartan and hydrochlorothiazideDiovan Hct · 104 products
• Lisinopril and hydrochlorothiazideZestoretic · 95 products
• Olmesartan medoxomil and hydrochlorothiazideBenicar Hct · 81 products
• Triamterene and hydrochlorothiazide69 products
• Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 43 products
• Bisoprolol fumarate and hydrochlorothiazide42 products
• Quinapril33 products
• Irbesartan and hydrochlorothiazideAvalide · 31 products
• Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 30 products
• Telmisartan and hydrochlorothiazideMicardis Hct · 27 products
• Benazepril hydrochloride and hydrochlorothiazideLotensin Hct · 21 products
• Candesartan cilexetil and hydrochlorothiazideAtacand Hct · 16 products
• Metoprolol tartrate and hydrochlorothiazide14 products
• Spironolactone and hydrochlorothiazide12 products
• Enalapril maleate and hydrochlorothiazideVaseretic · 5 products
• Captopril and hydrochlorothiazide4 products
• Fosinopril sodium and hydrochlorothiazide4 products
• Amiloride hydrochloride and hydrochlorothiazide1 product

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Lupin Pharmaceuticals, Inc.3 products
• Chartwell RX, LLC3 products
• Aurobindo Pharma Limited3 products
• Cipla USA Inc.3 products

FDA approval history

• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (3)

• ANDA076374Chartwell Rx · March 31, 2004
• ANDA078450Aurobindo Pharma · August 24, 2007
• ANDA201356Invagen Pharms · April 20, 2011

Shortage status

Current shortage · updated October 2, 2026 · first posted January 19, 2023

Ask your pharmacist whether your product is affected and what the options are.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

1. October 5, 2022 · Class II · Completed · D-0021-2023

   CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

   Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90 — Aurobindo Pharma USA Inc.

Official identifiers

Next steps

• Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
• Latest FDA drug recallsAll medicines, newest first
• Heart failureCondition named on the label: hospitals that treat it
• High blood pressureCondition named on the label: hospitals that treat it
• StrokeCondition named on the label: hospitals that treat it
• Lupin Pharmaceuticals, Inc.Maker or distributor
• Chartwell RX, LLCMaker or distributor
• Aurobindo Pharma LimitedMaker or distributor
• All prescription drugs A to ZSearch by generic, brand or Spanish name

Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Quinapril HCL and Hydrochlorothiazide, Lupin Pharmaceuticals,Inc., effective January 30, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers