USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, PRINIVIL should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.
PRINIVIL (Lisinopril), a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor.
PRINIVIL is indicated for the following:
PRINIVIL is indicated for the treatment of hypertension. It may be used alone as initial therapy or concomitantly with other classes of antihypertensive agents.
PRINIVIL is indicated as adjunctive therapy in the management of heart failure in patients who are not responding adequately to diuretics and digitalis.
Acute Myocardial Infarction
PRINIVIL is indicated for the treatment of hemodynamically stable patients within 24 hours of acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, aspirin and beta-blockers.
In using PRINIVIL, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that PRINIVIL does not have a similar risk. (See WARNINGS.)
In considering use of PRINIVIL, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in Black patients than in non-Blacks. In addition, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks (see WARNINGS, Anaphylactoid and Possibly Related Reactions, Angioedema).
Published Studies Related to Prinivil (Lisinopril)
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. [2011.06.15]
BACKGROUND: High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.
Potential pharmacodynamic drug-drug interaction between concomitantly administered lisinopril and diclofenac sodium: a call for appropriate management in hypertensive osteoarthritic patients. 
Abstract Background: The present study was designed as an open label, multiple-dose, randomized, parallel trial to evaluate the pharmacodynamic drug-drug interaction of lisinopril and concomitantly administered diclofenac sodium in non-diabetic and diabetic, mild to moderate hypertensive, osteoarthritic patients...
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study
protocol for a pilot randomised controlled trial. 
BACKGROUND: High blood pressure during acute stroke is associated with poorer
stroke outcome. Previous trials have failed to show benefit from lowering blood
pressure but treatment may have been commenced too late to be effective... The results will inform the design of a definitive RCT
to evaluate the effects of very early blood pressure lowering in acute stroke.
Carotid artery hemodynamics: observing patient-specific changes with amlodipine and lisinopril by using MR imaging computation fluid dynamics. [2010.12]
PURPOSE: To assess whether using magnetic resonance (MR) imaging combined with computational fluid dynamics (CFD) could reveal changes in common carotid artery (CCA) flow and wall shear stress (WSS) that might contribute to differences in CCA remodeling between amlodipine, a calcium channel blocker, and lisinopril, an angiotensin-converting enzyme inhibitor, despite similar reductions in blood pressure (BP)... CONCLUSION: Amlodipine causes increased blood flow and increased time-averaged WSS in the CCA compared with lisinopril, despite similar reductions in BP. Differences in the subacute hemodynamic effects of amlodipine and lisinopril could contribute to the differences in CCA remodeling seen in long-term studies. SUPPLEMENTAL MATERIAL: http://radiology.rsna.org/lookup/suppl/doi:10.1148/radiol.10100788/-/DC1. (c) RSNA, 2010
Comparison of the influence of angiotensin-converting enzyme inhibitor lisinopril and angiotensin II receptor antagonist losartan in patients with idiopathic membranous nephropathy and nephrotic syndrome. [2010.09]
CONCLUSION: Treatment with lisinopril and losartan in nephrotic patients with idiopathic membranous nephropathy results in similar (and significant) effects on renal function, hypoalbuminaemia, proteinuria and blood pressure.
Clinical Trials Related to Prinivil (Lisinopril)
A Study Investigating the Bioequivalence of the Fixed Dose Combination of COREG CR to COREG CR and ZESTRIL. [Completed]
This study will be a randomized study investigating the bioequivalence of COREG CR to its
components, COREG and Lisinopril (ZESTRIL). PK samples will be obtained throughout the study
to investigate the PK of COREG CR FDC to COREG and Lisinopril
Research Study To Test Coreg CR + Lisinopril Versus Lisinopril + Placebo In Patients With High Blood Pressure [Active, not recruiting]
Randomized, double-blind, parallel group, multicenter study of subjects with Stage 1 or 2
essential hypertension who are not at target blood pressure (<140/90mmHg) at Baseline.
Subjects will be randomized to received either COREG CR + lisinopril or lisinopril + placebo.
Subjects will be uptitrated over a 6 week period until target blood pressure (<140/90mmHg)
is met. The primary objective of the study is to compare the proportion of subjects who
achieve target blood pressure after 6 weeks of treatment.
A Pharmacodynamic/Pharmacokinetic Study of Aleglitazar in Patients With Type 2 Diabetes Mellitus on Treatment With Lisinopril [Recruiting]
This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the
effect of aleglitazar on renal function, the renin-angiotensin system and the
pharmacokinetics of lisinopril in patients with type 2 diabetes mellitus treated with
lisinopril. Patients on a stable dose of lisinopril (20 mg daily orally) for 2 weeks will be
randomized to receive either aleglitazar (150 mcg orally daily) or placebo in addition to
lisinopril for 4 weeks.
Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant [Recruiting]
The drug lisinopril is approved by the U. S. Food and Drug Administration for the treatment
of high blood pressure, heart failure, and acute heart attacks in adult patients. In
children over 6 years of age, lisinopril is approved for the treatment of high blood
pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme
inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals
that tighten the blood vessels so blood flows more smoothly and the heart can pump blood
There is some information available about how children with high blood pressure absorb,
distribute, metabolize, and eliminate lisinopril (this information about medication
processing by the body is called pharmacokinetic data). However, there is no information
about how children with high blood pressure who have received a kidney transplant process
lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril
may help kidney transplants work longer by reducing the activity of chemicals made by cells
in kidney transplants that can lead to inflammation and injury. Such benefits have not been
found with another group of blood pressure medications called calcium channel blockers,
which are the most commonly used medication group to control high blood pressure in children
after a kidney transplant. A clinical trial will be conducted in the future to compare which
medication group helps kidney transplants in children last longer. To guide the selection of
the best dose to test in future studies, investigators in this study will try to determine
the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and
adolescents (2-17 years of age) who have received a kidney transplant and have high blood
Antialbuminuric Effects of Valsartan and Lisinopril [Terminated]
Title: Antialbuminuric effect of valsartan, lisinopril and valsartan versus lisinopril in
non-diabetic and diabetic renal disease: a randomized (3: 3:1), open label, parallel group,
20 weeks follow-up.
Objective: To evaluate the antialbuminuric effect of high doses of valsartan vs lisinopril
vs combo treatment in non-diabetic and diabetic patients.
Hypothesis: Combo treatment reduces microalbuminuria and the albumin/creatinine ratio more
Design: Multicentric, randomized, open label, parallel group, active controlled.
Dose / regimen: Valsartan 320 vs Lisinopril 40 vs Valsartan/lisinopril 160/20
Primary Endpoint: Antialbuminuric effect of valsartan 320 mg, lisinopril and valsartan versus
lisinopril 40 mg in non-diabetic and diabetic renal disease following 5 months of follow-up.
Description % of change in albuminuria from baseline at 20 weeks.
Secondary Endpoint : To investigate the effect of 5 months treatment with
valsartan,lisinopril and valsartan versus lisinopril in GFR (Cl creatinine), also to
investigate the effect of 5 months treatment with valsartan, lisinopril and valsartan plus
lisinopril on blood pressure and the effect on left ventricular mass index using
electrocardiogram and Cornell-Sokolow method.
Reports of Suspected Prinivil (Lisinopril) Side Effects
Completed Suicide (24),
Renal Failure Acute (11),
Drug Ineffective (7),
Back Pain (7),
Hypertension (7), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 30 ratings/reviews, Prinivil has an overall score of 5.27. The effectiveness score is 7.13 and the side effect score is 6.60. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Prinivil review by 65 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || HBP|
|Dosage & duration:|| || 10-20mg taken once a day for the period of 27 years|
|Other conditions:|| || none|
|Other drugs taken:|| || Maxide, Atenolol|
|Benefits:|| || After starting on a diuretic and a beta blocker without significant results, adding the ACE inhibitor worked wonders, and has continued to do so for 27 years. The next step, if one becomes necessary will be to add a sartan. Based on my previous response. I expect it to be a happy experience. |
|Side effects:|| || For no apparent reason the dosage needs to be adjusted, up or down from time to time. Fortunately hypertension is not asymptomatic in this patient: have a headache, it's up, raise the dose; feel wiped out, it's down, lower the dose. All this has been confirmed by home, office, and pharmacy readings.|
|Comments:|| || I never expected to live this long, let alone feel as healthy as I do. My mother died at age 53, and the last years of her life were marred by pain, discomfort and significant disability due to cardiovascular disease.
My experience is one more validation of the benefits of early and aggressive intervention in the case of mild hypertension.|
Prinivil review by 45 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Moderate Side Effects|
|Condition / reason:|| || diabetes|
|Dosage & duration:|| || 2.5 MG taken one tablet/day for the period of two months|
|Other conditions:|| || none|
|Other drugs taken:|| || insulin: Lantis and humolog|
|Benefits:|| || Apparently, this ace inhibitor has positive effects against retinal and renal pathologies associated with diabetes and other cardio-vascular diseases.|
|Side effects:|| || Excessive prolonged coughing spells, especially at night, occasional diarrhea, isolated, patchy skin rashes on torso and extremities and itchy scalp all noticed within a week of starting this drug and has been persistent since.|
|Comments:|| || My doctor prescribed this medication as a prophylactic measure, since I have had Type I diabetes for the last 33 years. Recent tests have shown traces of protien in my urine possibly indicating early signs of renal failure.|
Prinivil review by 73 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Severe Side Effects|
|Condition / reason:|| || high blood pressure|
|Dosage & duration:|| || 2.5mg daily taken daily for the period of 6 months|
|Other conditions:|| || high cholesterol|
|Other drugs taken:|| || cholesterol med|
|Benefits:|| || blood pressure under control|
|Side effects:|| || Head itching, mouth and throat itchy swollen, cough, ringing in ears, bloating, extreme fatigue and depression.|
|Comments:|| || I have been off this medication for 2 weeks. No more itching/swelling, ringing. I still have some fatigue, but not constantly and hope that I will continue to improve.
While many people seem to take this drug without significant side effects, for some it is pure poison. Beware!|
Page last updated: 2013-02-10