Gadopril

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Gadopril

Quick Facts

Property Description
Active ingredient Enalapril maleate
Form Oral Tablet
Pharmacological class Angiotensin-Converting Enzyme Inhibitor (ACE Inhibitor)
Common use Antihypertensive (lowers blood pressure)
Origin Synthetic Compound

What Type of Medicine is Gadopril?

Gadopril is a synthetic, prescription-only cardiovascular medication whose active component is the substance Enalapril maleate. It is officially classified as an Angiotensin-Converting Enzyme Inhibitor (ACE Inhibitor), a core pharmacological group used in the management of systemic blood pressure and related heart conditions. This classification establishes its essential identity as an antihypertensive. The mechanism of ACE inhibitors is essential for blood pressure control. Furthermore, the compound is identified as a prodrug, meaning it is administered in an inactive form, which the body must convert into its therapeutically active metabolite, enalaprilat.

Composition and Form: The Enalapril Maleate Tablet

The physical presentation of Gadopril is typically an oral tablet formulation, designed for systemic absorption via the oral route of administration. As a single-ingredient product, its composition relies solely on the active pharmaceutical ingredient, Enalapril maleate, along with standard, inert pharmaceutical excipients necessary for the stable solid dosage form. Enalapril maleate is a treatment for decreasing vascular resistance. This formulation, containing only Enalapril, differentiates it from combination products often marketed for blood pressure management.

General Purpose: How it Helps the Heart and Vessels

The general purpose of Gadopril is to reduce systemic vascular resistance and thereby alleviate mechanical strain on the heart muscle. As an ACE Inhibitor, it achieves this by interfering with the body’s hormonal system responsible for tightening blood vessels, resulting in their subsequent widening, or vasodilation. This physiological effect of decreasing the load against which the heart must pump serves the therapeutic goal of managing chronic pressure elevation and protecting the vascular system. It is clinically recognized for being a cornerstone in long-term therapy for patients requiring consistent maintenance of lower blood pressure.

Regulatory References

  1. Enalapril: MedlinePlus Drug Information
  2. ACE inhibitors: MedlinePlus Medical Encyclopedia
  3. Enalapril - StatPearls - NCBI Bookshelf

What side effects are possible with Gadopril?

Possible side effects and safety information

The safety profile for Gadopril (Enalapril maleate) is formally classified by regulatory authorities based on observed frequency and the affected body system (System-Organ Class or SOC). This medication is an Angiotensin-Converting Enzyme (ACE) inhibitor, and its documented adverse reactions range from very common to very rare.

Very Common effects, often observed at an incidence rate of ge 1/10, include dizziness and headache. Common effects (ge 1/100 to < 1/10) encompass fatigue, hypotension (low blood pressure), and the characteristic non-productive cough often associated with the ACE inhibitor class. This cough may persist during treatment but typically resolves upon cessation.

Serious Adverse Reactions and Key Constraints

Official labeling documents specific, rare, but serious adverse reactions. The most critical is Angioedema, which involves rapid swelling of the face, lips, tongue, or larynx, and may occur at any time during treatment. Other serious reactions documented include Hepatic failure and Renal failure.

Safety constraints restrict the use of Gadopril in certain populations. It is contraindicated during the second and third trimesters of pregnancy due to the risk of fetal harm. Caution is advised, and monitoring of renal function and serum potassium is necessary, particularly in patients with renal impairment. Furthermore, the medication is contraindicated in individuals with a history of angioedema related to prior ACE inhibitor therapy and in combination with certain other cardiovascular medications, such as Neprilysin inhibitors.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Gadopril (Enalapril maleate) overdosage indicates that the primary toxic effect is a severe drop in blood pressure, known as profound hypotension. This can manifest as symptoms such as dizziness, lightheadedness, or loss of consciousness (stupor). Severe hypotension carries the risk of serious, life-threatening outcomes, including acute renal failure, cerebrovascular accident (stroke), or myocardial infarction in susceptible patients.

Required Emergency Actions

The regulatory guidance mandates that individuals seek immediate medical attention if overdosage is suspected. It is specifically stated that emergency services must be contacted immediately if the affected person collapses, has a seizure, or experiences loss of consciousness or difficulty breathing.

There is no specific antidote known for Gadopril overdosage. Management described in official documents is symptomatic and supportive, focusing on correcting the hypotension. This typically involves placing the patient in the supine position and administering an intravenous infusion of normal sodium chloride solution. For severe cases, procedures like hemodialysis are documented as a means to remove the active drug metabolite from the circulation. Close medical monitoring of blood pressure, kidney function, and electrolytes is required.

Therapeutic Uses of Gadopril

What Gadopril Treats: Main Uses and Benefits

Gadopril is used as part of a therapeutic regimen across several major cardiovascular domains. Relevant therapeutic applications generally include the long-term management of chronic systemic hypertension and the supportive care of symptomatic congestive heart failure.

It is also used to manage asymptomatic left ventricular dysfunction to assist with managing functional stress, and for renal protection in patients with specific forms of chronic kidney disease. Gadopril helps ease symptom clusters such as fatigue and shortness of breath associated with heart weakness, and may assist with maintaining functional stability for daily activities. This medication may support cardiovascular protection and assist with maintaining functional stability in conditions involving systemic imbalance.


Support for Cardiac Stress

Property Description
Primary Indication Chronic Systemic Hypertension
Secondary Indication Symptomatic Congestive Heart Failure
Symptom Focus Fatigue, Dyspnea (shortness of breath)
Patient Benefit Assists with maintaining functional stability

Regulatory References

  1. National Library of Medicine (NLM) DailyMed system

Eligibility and Restrictions for Use

Who Can and Cannot Use Gadopril?

The official eligibility for Gadopril (Enalapril maleate) is strictly defined by regulatory documents, distinguishing between approved use, conditional use, and absolute contraindications.

Contraindicated Populations (Must Not Use)

Contraindication Status Population/Condition
Absolute Patients with a history of angioedema related to any ACE Inhibitor.
Absolute Known hypersensitivity to Enalapril maleate or other ACE Inhibitors.
Absolute Use during the second or third trimesters of pregnancy.
Conditional Patients with diabetes or renal impairment (GFR < 60 mL/min) concurrently taking Aliskiren.

Restricted and Eligible Populations

Age-Related Eligibility: Gadopril is generally approved for use in adults for its indicated uses. For pediatric patients, use is established for hypertension in children from 1 month to 16 years of age, but it is not recommended for neonates (infants 1 month or younger) or children with severe kidney dysfunction. Older adult use requires careful initial dosing based on renal status.

Physiological Restrictions: Use is not recommended in the first trimester of pregnancy and must be discontinued immediately if pregnancy is detected. Use while breastfeeding is restricted or contraindicated by some regulatory bodies. Patients with impaired renal function require specific initial dosing and close monitoring, which is a key conditional restriction for use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes formally documented interaction patterns for Gadopril (Enalapril maleate) as recognized by government regulatory authorities.

Formal Contraindications and Restrictions

Co-administration of Gadopril with Aliskiren is contraindicated in patients with diabetes mellitus or established renal impairment (GFR below 60 mL/ min/1.73 m^2). The use of Neprilysin (NEP) Inhibitors (e.g., Sacubitril) is also contraindicated due to the documented risk of angioedema, requiring a mandatory 36-hour separation period when switching medications.

Exposure and Pharmacodynamic Effects

Interacting Agent Official Interaction Outcome
Lithium Reduces renal clearance, leading to increased serum lithium concentrations and toxicity risk.
Potassium-Sparing Agents/Supplements Combined potassium-retaining effect increases the risk of hyperkalemia (elevated serum potassium).
mTOR Inhibitors (e.g., Sirolimus, Everolimus) Increases the documented risk for angioedema.
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) May diminish the antihypertensive effect and increase the risk of renal function deterioration.

Administration Context

The label advises the discontinuation of diuretic therapy or an increase in salt intake prior to initiating Gadopril to mitigate the risk of excessive blood pressure reduction. Additionally, the absorption of Enalapril is officially documented as not influenced by the presence of food in the gastrointestinal tract.

Mechanism of Action

Gadopril functions as a dual angiotensin-converting enzyme (ACE) inhibitor and neutral endopeptidase (NEP) inhibitor. Its primary molecular interaction is the competitive inhibition of these two metalloproteases. In the renin-angiotensin-aldosterone system (RAAS), ACE inhibition prevents the conversion of angiotensin I to the vasoconstrictor, angiotensin II. Simultaneously, NEP inhibition blocks the enzymatic degradation of several endogenous vasodilatory peptides, including natriuretic peptides (NPs) and bradykinin. The resultant intracellular consequences are decreased generation of angiotensin II and reduced hydrolysis of NPs and bradykinin.

Downstream, the suppressed angiotensin II generation leads to decreased systemic vasoconstriction and lower aldosterone release, which modulates renal sodium and water retention. The enhanced availability of natriuretic peptides and bradykinin potentiates their actions: NPs promote natriuresis and diuresis, and bradykinin increases nitric oxide-mediated vasodilation. The system-level physiological consequence of this dual-pathway modulation is a net decrease in total peripheral vascular resistance and circulating volume.

Dosage and Administration Information

How Gadopril is Used: Administration Guidelines

Gadopril (Enalapril maleate) is primarily administered via the oral route as a tablet or solution. An intravenous (IV) formulation, enalaprilat, is available for use when oral administration is impractical. The absorption of the oral tablet is not influenced by food, allowing it to be taken with or without meals.

Standard Dosing and Schedule

Administration schedules are based on the condition being addressed. The medication is generally taken as a long-term maintenance therapy.

Condition Initial Dose (Adults) Maintenance Dose (Adults) Frequency
Hypertension 5 mg once daily 10 mg to 40 mg daily (Max 40 mg) Once daily; may be divided twice daily
Heart Failure/LVD 2.5 mg once or twice daily Titrated up to 20 mg daily Twice daily

Dose Adjustments and Special Instructions

Dose adjustments and specific conditions for administration include:

  • Renal Impairment: For patients with moderate to severe renal impairment (Creatinine Clearance less than or equal to 30 mL/min), the initial oral dose is reduced to 2.5 mg once daily. Patients on dialysis are given 2.5 mg on dialysis days.
  • Diuretics: If possible, diuretic therapy should be discontinued 2–3 days prior to initiating Gadopril to allow for safe starting dose administration. If not, the initial dose is typically 2.5 mg daily.
  • Titration: Dosage increases, especially for heart failure, are recommended to be performed gradually over a 2 to 4-week period and under close medical supervision to monitor the initial effects.
  • Pediatric Use: For children over one month of age, the starting dose is based on body weight (0.08 mg/kg up to 5 mg) once daily.

If a dose is missed, it should not be doubled; the patient should take the next scheduled dose as usual.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Gadopril

Evidence for Use in Chronic Systemic Hypertension

Research examined the use of Gadopril through large-scale Randomized Controlled Trials (RCTs) and comprehensive meta-analyses. These studies were designed to evaluate change in systemic blood pressure levels and to observe patterns related to serious cardiovascular events over time. The research included a wide range of adults with hypertension.

Studies consistently reported measurements of change in systemic blood pressure. The reports from longer-term trials exploring major cardiovascular events monitored the occurrence of serious events. Patterns in the monitored data were described. The medicine was studied for use in children older than one month, but the data regarding long-term outcomes is more limited in this pediatric population compared to the evidence base for adults.


Evidence for Use in Symptomatic Congestive Heart Failure

Research concerning heart failure was evaluated in pivotal Randomized Double-Blind Trials. These studies focused on adults with heart weakness, specifically those with a reduced ability to pump blood. The trials concentrated on long-term survival (all-cause mortality), the frequency of hospitalization, and changes in the patient's functional status.

Initial survival trials monitored patient mortality rates. Observed data patterns were noted. Studies also described measurements related to the rate of cardiovascular hospitalizations that were observed to be lower. Findings indicated that the patterns observed in short-term assessments continued to be present over subsequent long-term observation.


Evidence for Renal Protection in Chronic Kidney Disease

Research examined whether the use of the medicine was associated with a change in the rate of loss of kidney function in adults with protein leakage (proteinuria). Studies examined changes in kidney function biomarkers, including protein or albumin in the urine and the decline of the estimated Glomerular Filtration Rate (eGFR).

Reports consistently described measurements showing a change in albuminuria and proteinuria across the studied populations. However, concerning the long-term impact on the rate of eGFR decline, the findings were mixed, and the change was sometimes minimal or did not reach statistical significance over the study period. Data are still emerging in this area.

Key Studies & References

  1. Enalapril Maleate Tablet Oral Official FDA Prescribing Information and Monograph (DailyMed)

Frequently Asked Questions (FAQ)

Common questions about Gadopril (FAQ)

Q: What is the main difference between Gadopril and other similar medicines I see advertised?

A: According to official product information, Gadopril belongs to the Angiotensin-Converting Enzyme (ACE) inhibitor class of medicines. Its mechanism is to block an enzyme that produces a substance that tightens blood vessels. This action distinguishes it from other classes of blood pressure medication, such as those that block hormone receptors or those that affect calcium channels.

Q: What specific foods or drinks should people be cautious about consuming while taking Gadopril?

A: Regulatory warnings advise against the use of potassium supplements or potassium-containing salt substitutes due to the potential risk of hyperkalemia, which is high blood potassium. Official information indicates that the consumption of alcohol may enhance the hypotensive effect of the medication.

Q: If I have a history of allergies, is it safe to take Gadopril?

A: Official information states that the drug is contraindicated if a person has a known hypersensitivity to the active ingredient or has a history of a specific severe swelling reaction called angioedema related to a previous ACE inhibitor medicine. The drug label describes these specific drug-related reactions as contraindications.

Q: Why do official sources sometimes use different names or abbreviations for Gadopril?

A: The generic name for the active ingredient is Enalapril maleate. It is described as a prodrug, which means the body converts it into its active form, enalaprilat, which provides the therapeutic effect. These different names refer to the different chemical forms of the drug.

Q: Is Gadopril considered a 'high-risk' medicine in terms of safety classifications?

A: The drug is required to carry an FDA Boxed Warning, which is the highest safety alert used to highlight serious or life-threatening risks. This warning specifically addresses the risk of Fetal Toxicity, including injury and death to a fetus, if the drug is used during the second and third trimesters of pregnancy.

Q: Can a person take Gadopril if they are also taking supplements like vitamins or herbal remedies?

A: Official drug labels list specific interactions with other medications. Official labeling does not address general supplements, but regulatory agencies emphasize the importance of communicating all medications and supplements to a healthcare provider for comprehensive risk assessment.

Q: Are there different strengths of Gadopril, and what does that mean?

A: Yes, the tablet is supplied in multiple strengths, such as 2.5 mg, 5 mg, 10 mg, and 20 mg. The strength indicates the specific amount of the active ingredient, Enalapril maleate, that is present in each individual tablet.

Q: What is the connection between Gadopril and fluid retention mentioned in some articles?

A: The official mechanism of action indicates that the drug works to reduce fluid retention in the body. It does this by suppressing the hormone aldosterone, which normally signals the body to retain sodium and water. This physiological effect means the medicine is studied for use in conditions where reduced fluid retention is a therapeutic goal, such as heart failure.

Q: Can individuals with liver conditions safely take Gadopril?

A: The medication requires activation by the liver, and Hepatic failure is noted as a serious, rare adverse event. While dose adjustment is not typically mandated for stable liver impairment, the possibility of liver injury, such as jaundice, is noted as a serious adverse event that requires medical assessment.

Q: Can Gadopril affect the results of routine lab tests or blood work?

A: Yes, the medication can affect certain blood test results. Monitoring of serum potassium is necessary due to the potential risk of high blood potassium (hyperkalemia). Additionally, increases in kidney function biomarkers, such as serum urea and creatinine, may be observed in some patients.

Q: How is the safety profile of Gadopril described for people with heart conditions?

A: The medicine is approved for the treatment of specific heart conditions like Heart Failure. However, the risk of excessive hypotension (very low blood pressure) is higher in these patients. Official guidance indicates that due to the risk of excessive hypotension, the initial use and any subsequent dose adjustments should be performed under medical monitoring.

Q: What are the official recommendations for storing Gadopril tablets or liquid forms?

A: Official storage guidelines require that tablets be maintained at Controlled Room Temperature and protected from moisture in their original, tightly closed container. The medication is also available as an oral solution, which has specific storage instructions after it is mixed.

Q: Can Gadopril be safely used by patients with diabetes?

A: According to regulatory documents, the drug can be used by patients with diabetes, but it is contraindicated (must not be used) in patients who are concurrently taking the medication Aliskiren. This specific combination carries increased risks of severe renal impairment and hyperkalemia.

Q: How quickly should I expect to notice the effects of Gadopril?

A: Official pharmacokinetic information indicates that the antihypertensive effect generally begins within about one hour after taking the oral dose. The full blood pressure reduction is expected to reach its peak effect in four to six hours.

Q: What happens if I stop taking Gadopril suddenly?

A: The medication is typically prescribed for chronic, long-term therapy. Abruptly discontinuing any ACE inhibitor can sometimes lead to a rapid increase in blood pressure in certain patients. The drug is intended for chronic therapy, and regulatory information advises that all changes to treatment status be determined by a healthcare provider.

Q: Does taking Gadopril affect my ability to drive or operate machinery?

A: Regulatory safety information indicates that the ability to drive or operate machinery may be impaired. This is because the drug can cause side effects such as dizziness, tiredness, or blurred vision. Official sources note that due to these effects, individuals should be aware of the possibility of impaired ability, particularly during the initial phase of treatment or following a dose adjustment.

Q: What is the typical time frame for the body to eliminate Gadopril after stopping use?

A: The active substance in the body, enalaprilat, has an effective elimination half-life of approximately 11 hours following multiple doses. The half-life is a pharmaceutical measure of the time it takes for the concentration of the substance in the body to be reduced by half.

Q: Is it common to experience skin reactions or rashes while using Gadopril?

A: Official adverse reaction data lists a general skin rash as an Uncommon side effect, meaning it was reported in less than 1% of patients in clinical trials. A severe, rapid swelling of the face and throat, called Angioedema, is a rare but serious reaction that is specifically highlighted in safety warnings.

Q: Do researchers know why Gadopril is sometimes less effective in certain populations?

A: Clinical studies have noted that the blood pressure-lowering effect of ACE inhibitors may be less pronounced in Black patients compared to non-Black patients. Official documents also report that Black patients have a higher incidence of angioedema (severe swelling).

Q: What is the difference between the brand name and generic versions of Gadopril?

A: The medicine is the generic version of brand names such as Vasotec. The generic version contains the identical active ingredient, Enalapril maleate, and is required to meet the same quality standards as the brand name product.

Q: How long has Gadopril been available on the market?

A: The active ingredient, Enalapril maleate, was first approved for medical use in the United States in 1985. It has been an established treatment for heart and blood pressure conditions for several decades.

Q: Do the side effects of Gadopril get better over time?

A: Official labeling does not provide a general statement regarding the improvement of all side effects over time. However, the label does specifically note that the common, characteristic ACE-inhibitor cough may persist during treatment but typically resolves upon cessation of the drug.

Q: What does 'Black Box Warning' mean, and does Gadopril have one?

A: Yes, the drug carries a mandatory FDA Boxed Warning. This is the agency's highest alert to bring attention to a serious or potentially life-threatening risk associated with the medication. The warning for this product concerns the risk of Fetal Toxicity.

Q: What evidence exists about Gadopril's interaction with alcohol?

A: Official warnings state that the consumption of alcohol may enhance the hypotensive effect (blood pressure lowering) of the medicine. This may result in an increased likelihood of experiencing symptoms like dizziness or lightheadedness.

Q: Do studies examine the impact of Gadopril on mental clarity or mood?

A: Adverse reaction data includes central nervous system effects such as dizziness, headache, confusion, and somnolence (drowsiness). These are side effects that are known to potentially impact mental clarity.

Q: Is there a maximum length of time a person can safely take Gadopril?

A: The drug is indicated for chronic conditions and is designed for long-term maintenance therapy. Regulatory labeling does not specify a mandatory maximum duration for use, and the length of treatment is determined by clinical response.

Q: Is the risk of side effects higher with higher doses of Gadopril?

A: Official information suggests that the frequency of some side effects, notably hypotension (low blood pressure) and dizziness, can be more pronounced at the beginning of treatment or following a dose increase. This indicates that risk may be influenced by the quantity or change in the drug being administered.

Q: Is it true that Gadopril can cause changes in taste or smell?

A: Official adverse reaction data lists taste alteration (dysgeusia) as an Uncommon side effect reported in clinical trials. Loss of smell (anosmia) has also been reported in the post-marketing surveillance data.

Q: What is the half-life of Gadopril as described in official documents?

A: The drug's active substance, enalaprilat, has an effective elimination half-life of approximately 11 hours following repeated oral doses. The half-life is a pharmaceutical measure of the time it takes for the concentration of the substance in the body to be reduced by half.

How should Gadopril be stored and disposed of?

Storage and Disposal of Gadopril

Gadopril (Enalapril maleate) tablets must be stored at Controlled Room Temperature, specifically maintained between 20 C and 25 C (68 F and 77 F). The product requires protection from moisture and must be kept in its original container, which should be tightly closed.

Storage Requirement Condition
Temperature 20 C to 25 C
Protection Protect from moisture
Container Original and tightly closed

Storage must ensure the medicine remains out of the reach of children. For disposal, any unused or expired Gadopril must be discarded according to local regulations for pharmaceutical waste and should not be disposed of via household drains or wastewater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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