Quinapril
/api/v1/drug/quinaprilMechanism of action
Sourced from openFDAMechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.
Indications
Sourced from openFDA- Hypertension Quinapril tablets are 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.ICD-10: I10
Contraindications
Sourced from openFDA- Quinapril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).contraindicated
Dosage & administration
Sourced from openFDAHypertension Monotherapy: The recommended initial dosage of quinapril in patients not on diuretics is 10 or 20 mg once daily. Dosage should be adjusted according to blood pressure response measured at peak (2–6 hours after dosing) and trough (predosing). Generally, dosage adjustments should be made at intervals of at least 2 weeks. Most patients have required dosages of 20, 40, or 80 mg/day, given as a single dose or in two equally divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients an increase in dosage or twice daily administration may be warranted. In general, doses of 40–80 mg and divided doses give a somewhat greater effect at the end of the dosing interval. Concomitant Diuretics: If blood pressure is not adequately controlled with quinapril monotherapy, a diuretic may be added. In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of quinapril. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued 2 to 3 days prior to beginning therapy with quinapril (see WARNINGS ). Then, if blood pressure is not controlled with quinapril alone, diuretic therapy should be resumed. If the diuretic cannot be discontinued, an initial dose of 5 mg quinapril should be used with careful medical supervision for several hours and until blood pressure has stabilized.
Warnings & precautions
Sourced from openFDAFETAL TOXICITY • When pregnancy is detected, discontinue quinapril 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
Adverse reactions
Sourced from openFDAHypertension Quinapril has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. Quinapril has been evaluated for long-term safety in over 1400 patients treated for 1 year or more. Adverse experiences were usually mild and transient. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension. Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with quinapril are shown below. Adverse Events in Placebo-Controlled Trials Quinapril Placebo (N=1563) (N=579) Incidence Incidence (Discontinuance) (Discontinuance) Headache 5.6 (0.7) 10.9 (0.7) Dizziness 3.9 (0.8) 2.6 (0.2) Fatigue 2.6 (0.3) 1.0 Coughing 2.0 (0.5) 0.0 Nausea and/or Vomiting 1.4 (0.3) 1.9 (0.2) Abdominal Pain 1.0 (0.2) 0.7 Heart Failure Quinapril has been evaluated for safety in 1222 quinapril treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure. Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with quinapril are shown below.
Overdosage
Sourced from openFDADoses of 1440 to 4280 mg/kg of quinapril cause significant lethality in mice and rats. No specific information is available on the treatment of overdosage with quinapril. The most likely clinical manifestation would be symptoms attributable to severe hypotension. 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 (eg, maneuvers to change 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.
Approval history
Sourced from openFDA- Mar 31, 2004ANDAANDA076374Chartwell Rx
- Mar 2, 2005ANDAANDA076803Chartwell Rx
- Jun 20, 2006ANDAANDA077690Lupin
- Aug 24, 2007ANDAANDA078450Aurobindo Pharma
- Aug 24, 2007ANDAANDA078457Invagen Pharms
- Apr 20, 2011ANDAANDA201356Invagen Pharms
- Apr 29, 2013ANDAANDA202725Aurobindo Pharma Ltd
- Sep 15, 2016ANDAANDA205823Prinston Inc
FDA shortages
Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.
- Quinapril Hydrochloride, Tablet, 10 mg (NDC 43547-411-09)ActiveSponsor: Solco Healthcare US, LLC · Reason: Shortage of an active ingredientUpdated
- Quinapril Hydrochloride, Tablet, 10 mg (NDC 62135-485-90)ActiveSponsor: Chartwell Molecular Holdings LLCUpdated
- Quinapril Hydrochloride, Tablet, 10 mg (NDC 68180-557-09)ActiveSponsor: Lupin Pharmaceuticals, Inc. · Reason: Requirements related to complying with good manufacturing practicesUpdated
- Quinapril Hydrochloride, Tablet, 20 mg (NDC 43547-412-09)ActiveSponsor: Solco Healthcare US, LLC · Reason: Shortage of an active ingredientUpdated
- Quinapril Hydrochloride, Tablet, 20 mg (NDC 62135-486-90)ActiveSponsor: Chartwell Molecular Holdings LLCUpdated
- Quinapril Hydrochloride, Tablet, 20 mg (NDC 68180-558-09)ActiveSponsor: Lupin Pharmaceuticals, Inc. · Reason: Requirements related to complying with good manufacturing practicesUpdated
- Quinapril Hydrochloride, Tablet, 40 mg (NDC 43547-413-09)ActiveSponsor: Solco Healthcare US, LLC · Reason: Shortage of an active ingredientUpdated
- Quinapril Hydrochloride, Tablet, 40 mg (NDC 62135-487-90)ActiveSponsor: Chartwell Molecular Holdings LLCUpdated
- Quinapril Hydrochloride, Tablet, 40 mg (NDC 68180-554-09)ActiveSponsor: Lupin Pharmaceuticals, Inc. · Reason: Requirements related to complying with good manufacturing practicesUpdated
- Quinapril Hydrochloride, Tablet, 5 mg (NDC 43547-410-09)ActiveSponsor: Solco Healthcare US, LLC · Reason: Shortage of an active ingredientUpdated
- Quinapril Hydrochloride, Tablet, 5 mg (NDC 62135-484-60)ActiveSponsor: Chartwell Molecular Holdings LLCUpdated
FAERS reports
- 1Fall90511%
- 2Pain7589.5%
- 3Hypotension7169.0%
- 4Constipation7129.0%
- 5Balance Disorder6418.1%
- 6Cognitive Disorder6317.9%
- 7Orthostatic Hypotension6217.8%
- 8Sedation5767.2%
- 9Mobility Decreased5436.8%
- 10Depressed Level Of Consciousness5356.7%
- 11Sedation Complication5356.7%
- 12Toxicity To Various Agents5326.7%
- 13Blood Calcium Decreased5236.6%
- 14Dyspnoea5196.5%
- 15Creatinine Renal Clearance Decreased5156.5%
Literature
Recent PubMed references pinned to Quinapril as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Binder jetting 3D printing of challenging medicines: From low dose tablets to hydrophobic molecules.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2022 · Kozakiewicz-Latała M, Nartowski KP, Dominik A, et al.PMID 34785345DOI 10.1016/j.ejpb.2021.11.001
- Pulmonary adverse drug event data in hypertension with implications on COVID-19 morbidity.Scientific reports · 2021 · Jaberi-Douraki M, Meyer E, Riviere J, et al.PMID 34172790DOI 10.1038/s41598-021-92734-7
Clinical trials
The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Quinapril as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.
- Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)Not yet recruiting · Phase 4 · Interventional · 64 enrolled · Baylor Research InstituteNCT07547878updated 2026-05-08
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort StudyNot yet recruiting · Observational · 13,656 enrolled · First Teaching Hospital of Tianjin University of Traditional Chinese MedicineNCT07262710updated 2025-12-04
- Effect of Sacubitril/Valsartan on Cardiac Function in Hypertensive Patients Stratified by BMI: A Real World StudyRecruiting · Observational · 180 enrolled · Beijing Friendship HospitalNCT05498675updated 2025-02-13
- Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated HypertensionActive not recruiting · Observational · 9,464 enrolled · Groupe Hospitalier Pitie-SalpetriereNCT06515678updated 2024-07-26
- Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgCompleted · Phase 1 · Interventional · 60 enrolled · Mylan Pharmaceuticals IncNCT00649103updated 2024-04-24
- Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgCompleted · Phase 1 · Interventional · 24 enrolled · Mylan Pharmaceuticals IncNCT00649649updated 2024-04-24
- Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mgCompleted · Phase 1 · Interventional · 60 enrolled · Mylan Pharmaceuticals IncNCT00649441updated 2024-04-24
- Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mgCompleted · Phase 1 · Interventional · 44 enrolled · Mylan Pharmaceuticals IncNCT00648011updated 2024-04-24
- Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk SurgeryCompleted · Phase 4 · Interventional · 291 enrolled · University of NebraskaNCT01669434updated 2023-09-25
- NT-proBNP Selected Prevention of Cardiac Events in Diabetic PatientsRecruiting · Phase 4 · Interventional · 2,400 enrolled · Martin HuelsmannNCT02817360updated 2023-03-14
Structural analogs
Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.
Frequently asked questions
- How does Quinapril work?
- Mechanism-of-action classes: Angiotensin-converting Enzyme Inhibitors; Neprilysin Inhibitors.
- What is Quinapril used for?
- According to FDA labeling, Quinapril carries indications including: Hypertension Quinapril tablets are 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
- What class of drug is Quinapril?
- Quinapril is classified as ACE inhibitors, plain, Angiotensin Converting Enzyme Inhibitor, Angiotensin-converting Enzyme Inhibitors, Neprilysin Inhibitors, Decreased Blood Pressure, Decreased Bradykinin Degradation, Decreased Intravascular Volume, Decreased Mineralocorticoid Secretion, Decreased Renal K+ Excretion, Increased Renal Na+ Excretion, Renal Arterial Vasodilation.
- What are the brand names for Quinapril?
- Quinapril is marketed under brand names including Accupril, Accuretic.
- What are the contraindications for Quinapril?
- Quinapril labeling lists contraindications including: Quinapril tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an ACE inhibitor. Quinapril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril).. Always consult the full prescribing information and a clinician.
quinapril is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.