Enaladil

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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 Enaladil

What is Enaladil?

Enaladil is a medication belonging to the class of drugs known as angiotensin-converting enzyme (ACE) inhibitors. It is primarily used in the management of cardiovascular conditions, specifically hypertension and certain types of heart failure.

Mechanism of Action

The medication works by interfering with the body's renin-angiotensin-aldosterone system. It inhibits the enzyme responsible for converting angiotensin I into angiotensin II. Since angiotensin II is a potent substance that causes blood vessels to tighten and narrow, reducing its production allows the blood vessels to relax and widen. This process results in lower blood pressure and reduces the workload on the heart, making it easier for the heart to pump blood throughout the body.

Clinical Applications

Enaladil is utilized in various clinical settings to improve cardiovascular health outcomes:

  • Hypertension: It is used to manage high blood pressure, which helps prevent long-term complications such as strokes and heart attacks.
  • Heart Failure: It is used to manage symptomatic heart failure, often in combination with other medications, to improve heart function and reduce the frequency of hospitalizations.
  • Asymptomatic Left Ventricular Dysfunction: It may be used in patients who do not yet show symptoms of heart failure but have a weakened left ventricle, helping to delay the progression of the condition.

Physical Characteristics

As a therapeutic agent, Enaladil is typically administered orally. Once ingested, it undergoes a metabolic process in the liver where it is converted into its active form, enalaprilat, which then carries out the primary medicinal effects within the circulatory system.

Regulatory References

  1. NCBI Bookshelf, StatPearls

What side effects are possible with Enaladil?

Possible Side Effects and Safety Information

Enaladil (enalapril maleate) is a medication whose adverse reactions and safety characteristics are formally documented and classified by government regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Documented Adverse Reactions and Frequency

Adverse reactions are classified by how often they occur, based on regulatory standards:

Frequency Examples of Documented Side Effects
Very Common (≥ 1/10) Cough, Dizziness, Nausea, Asthenia (weakness)
Common (≥ 1/100 to < 1/10) Headache, Hypotension, Chest Pain, Diarrhoea, Rash, Hyperkalaemia
Uncommon (≥ 1/1,000 to < 1/100) Anaemia, Pancreatitis, Renal Dysfunction/Failure, Impotence
Rare (≥ 1/10,000 to < 1/1,000) Hepatic Failure, Jaundice, Stevens-Johnson Syndrome

Serious Adverse Reactions and Safety Warnings

Official labeling emphasizes certain serious or critical safety risks:

  • Angioedema: Swelling of the face, lips, tongue, glottis, and larynx has been reported and can be potentially fatal due to airway obstruction. Angioedema can occur at any time during treatment.
  • Fetal Toxicity: Use during the second and third trimesters of pregnancy can cause injury and death to the developing fetus. The medication must be discontinued immediately if pregnancy is detected.
  • Severe Hypotension: Significant drops in blood pressure may occur, most often with the initial dose, which in high-risk patients may lead to secondary events such as Myocardial Infarction or Cerebrovascular Accident.
  • Hepatic and Renal Failure: Cases of serious liver failure and renal failure have been documented, particularly in susceptible patients.

Population-Specific Safety Considerations

Regulatory documents include specific notes for certain patient populations:

  • Black Patients have a reported higher incidence of Angioedema.
  • Renal Artery Stenosis patients are at increased risk of severe hypotension and renal dysfunction.
  • Elderly patients are more likely to have age-related compromise of renal function.

Safety-Related Restrictions: The medication is contraindicated in individuals with a history of Hereditary or Idiopathic Angioedema and must not be used within 36 hours of taking a Neprilysin Inhibitor.

Overdose and Emergency Response

The official regulatory profile for Enaladil overdose is defined by a significant exaggeration of its therapeutic action, leading to severe physiological manifestations.

Documented signs of overdose, which is classified as a potentially life-threatening emergency, include marked hypotension (excessive low blood pressure), stupor, and symptoms of renal distress such as oliguria (reduced urine output) and progressive azotemia. The most serious documented outcomes of overexposure are acute renal failure and, rarely, death.

Immediate medical attention must be sought for any suspected overdose or for the sudden onset of life-threatening symptoms, including severe hypotension, fainting, or swelling associated with angioedema that affects breathing. Regulatory guidance states that patients experiencing symptomatic hypotension should be placed in the supine position and that immediate care often involves volume expansion through intravenous infusion of normal saline solution.

Management protocols focus on supportive and symptomatic treatment, as no specific antidote is known. A critical procedural step documented in regulatory information is that the active metabolite, enalaprilat, can be effectively removed from the body via hemodialysis. Special considerations apply to patients with existing renal insufficiency, where the elimination half-life of enalaprilat is prolonged.

Therapeutic Uses of Enaladil

What Enaladil treats: main uses and benefits

Enaladil (enalapril) is a prescription medication utilized in a patient's overall therapeutic strategy for managing certain heart and circulatory conditions. It may be prescribed alone or in combination with other therapies, as determined by a healthcare provider. The primary indications for Enaladil involve supporting the management of chronic high blood pressure (hypertension), providing assistance for certain stages of symptomatic heart failure, and addressing asymptomatic left ventricular dysfunction.

The medication assists in maintaining blood pressure levels within an acceptable range for the patient. Consistent management of this condition is a key component of a health strategy to influence the potential for serious outcomes, such as stroke or heart attack. Enaladil may also be an element of the medical approach focused on supporting kidney function in patients with specific comorbidities, like diabetes and hypertension.


Quick Fact: Relief for Hypertension

Eligibility and Restrictions for Use

Who Can and Cannot Use Enaladil? — Official Regulatory Information

Official regulatory documents define strict population-based rules for the use of Enaladil (enalapril maleate).

Populations For Whom Use is Contraindicated (Must Not Use):

  • Patients with a history of angioedema (severe swelling) related to prior treatment with any ACE inhibitor, or those with hereditary or idiopathic angioedema.
  • Pregnant patients during the second and third trimesters, as use can cause fetal injury and death. Discontinuation is mandated immediately upon detection of pregnancy.
  • Patients using aliskiren who also have diabetes mellitus or impaired renal function (GFR < 60 mL/min/1.73 m^2).
  • Patients who have recently used sacubitril/valsartan (within 36 hours of switching).

Age and Condition-Based Eligibility:

  • Adults are eligible for all approved indications. Children ge 1 month of age are approved for hypertension treatment, but use is not recommended in infants le 1 month of age.
  • Use is not recommended in pediatric patients with severe renal impairment (GFR < 30 mL/min/1.73 m^2).
  • Lactating patients (breastfeeding) are advised that use is not recommended.
  • Patients with certain conditions, such as severe heart failure, hepatic impairment, or renal artery stenosis, are eligible but require close medical supervision and monitoring at treatment initiation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information outlines several substances and classes that interact with Enaladil (enalapril), defining specific co-administration restrictions and prohibitions.


Mandatory Prohibitions and Restrictions

Classification Interacting Substance/Class Restriction Detail
Contraindicated Sacubitril/Valsartan (ARNI) Use is prohibited due to significantly increased risk of angioedema. A 36-hour separation window is required when switching between these agents.
Contraindicated Aliskiren (Direct Renin Inhibitor) Use is prohibited in patients with diabetes mellitus or those with renal impairment (GFR less than 60 mL/min).
Procedural Ban High-flux Polyacrylonitrile Membranes Prohibited for use during dialysis due to the risk of severe anaphylactoid reactions.

Clinically Significant Pharmacodynamic Effects

Enaladil's effects lead to additive risks when combined with other agents affecting blood pressure or potassium balance:

  • Hyperkalemia Risk: Co-administration with Potassium-sparing Diuretics (e.g., Spironolactone, Amiloride) or Potassium Supplements/Salt Substitutes may cause elevated serum potassium levels.
  • Renal and Hypotension Risk: Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may reduce the blood pressure-lowering effect and increase the risk of renal function deterioration, especially in patients with pre-existing impaired renal function.
  • Exposure Alteration: Co-administration with Lithium may increase serum lithium concentrations and the risk of toxicity, requiring close monitoring.

These documented interactions structure the product’s official profile, identifying combination boundaries related to the risk of angioedema, hyperkalemia, and dual RAAS blockade.

Mechanism of Action

Inhibition of the ACE Enzyme: The Molecular Blockade

Enaladil's active form, Enalaprilat, is a competitive inhibitor of the enzyme Angiotensin-Converting Enzyme (ACE). This mechanism acts as a molecular blockade, stopping ACE from converting the inactive precursor Angiotensin I into the vasoconstrictor Angiotensin II, which is a primary driver of the Renin-Angiotensin-Aldosterone System (RAAS).

Systemic Pathway Modulation and Kinin Preservation

By suppressing the RAAS, the drug dampens a primary signaling pathway influencing blood vessel constriction and fluid retention. Simultaneously, the inhibition of ACE slows the breakdown of the natural vasodilator Bradykinin (part of the Kallikrein-Kinin System), resulting in the accumulation of the vasodilator Bradykinin.

Resulting Physiological Consequences

These combined mechanistic effects lead directly to key physiological changes: a reduction in systemic vascular resistance (blood vessels widen) and a decrease in total circulating fluid volume (due to reduced aldosterone signaling). The combination of decreased resistance and reduced volume affects the pressure dynamics of the circulatory system.

Dosage and Administration Information

Enaladil (enalapril maleate) is a medication primarily intended for oral administration in the form of tablets or an oral solution. The drug may be taken with or without food, as its absorption is not influenced by meals.

Official Dosing and Frequency

The frequency of use is typically once or twice daily, depending on the condition. The total daily dosage must not exceed 40 mg.

Condition Initial Oral Dose Maintenance Range (Max 40 mg/day)
Hypertension (Adult) 5 mg once daily (2.5 mg if taking diuretics) 10 mg to 40 mg daily
Heart Failure (Adult) 2.5 mg twice daily (b.i.d.) Up to 20 mg twice daily

Procedural Administration Constraints

Treatment initiation, especially for heart failure, often involves a gradual dose titration over a period of two to four weeks under close medical observation.

Population-Specific Adjustments For patients with moderate to severe renal impairment (Creatinine Clearance le 30 mL/min), the initial oral dose must be reduced to 2.5 mg once daily. For pediatric patients (ge 1 month with hypertension), the starting dose is based on body weight, typically 0.08 mg/kg once daily.

Missed Dose If a dose is missed, it is generally recommended to take the dose as soon as possible, but not to take a double dose to compensate for the forgotten one. The oral solution form requires reconstitution prior to dispensing.

Recent Clinical Evidence

Overview of Research Evidence for Enaladil

Evidence for use in Chronic Stable Angina

Research into Enaladil was studied for chronic stable angina primarily through short-term randomized controlled trials (RCTs) and subsequent meta-analyses. Researchers explored outcomes related to physical discomfort, measuring changes in exercise tolerance time and patient-reported outcomes describing perceived discomfort.

The studies report how symptoms evolved over defined, short time intervals. Studies reported measurements showing patterns related to a delayed onset of symptoms during exercise and differences in the reported frequency of discomfort episodes compared to controls. Findings were mixed across the total body of evidence, and the data show patterns related to these outcomes only over the short periods studied.

Evidence is limited regarding the long-term impact on functional measures beyond six months. Results apply only to the populations studied, and long-term effects on major heart events are not fully established.


Evidence for use in Ischemic Cardiomyopathy / Heart Failure

Enaladil was evaluated in ischemic cardiomyopathy and heart failure in longer-duration randomized controlled trials. Research examined outcomes related to systemic or functional imbalance, such as the heart’s pumping function (LVEF) and physical performance. Studies also monitored outcomes reflecting daily functioning and observed if the medicine was associated with changes in the frequency of hospitalizations.

Studies monitored changes in measured heart function and outcomes reflecting daily functioning or activity level. Research describes patterns where a lower rate of heart failure-related hospitalizations was observed in some studies. Findings were mixed when it came to major outcomes like all-cause mortality, and data show patterns related to these endpoints that are still emerging.


What is Still Uncertain about Enaladil

The research has provided context but not individual predictions. Evidence highlights what is known—and what is still uncertain. The primary gaps concern the characterization of long-term outcomes, as follow-up durations were limited in many trials. Data are still emerging regarding the consistent effects across all subgroups and the true impact on major, long-term clinical events. The available findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly.

Key Studies & References

  1. Enalapril and Enalaprilat Pharmacokinetics in Children with Heart Failure Due to Dilated Cardiomyopathy and Congestive Heart Failure after Administration of an Orodispersible Enalapril Minitablet (LENA-Studies)
  2. Meta-Analysis: The Impact of Heart Failure Medications in Improving Left Ventricular Function in Chemotherapy Induced Cardiomyopathy (Referencing ACEI findings for heart failure outcomes)

Frequently Asked Questions (FAQ)

Common questions about Enaladil (FAQ)

Q: Is Enaladil safe to take with common over-the-counter painkillers like ibuprofen or acetaminophen?

A: Official drug information indicates that non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may reduce the intended blood pressure-lowering effect of Enaladil. Co-administration of NSAIDs may also increase the risk of kidney problems, particularly for individuals with pre-existing renal issues. Regulatory documents do not list a specific interaction warning for acetaminophen.

Q: Can older adults (seniors) take Enaladil safely, according to the official label guidelines?

A: Regulatory documents acknowledge that older adults are more likely to experience age-related changes in kidney function. For this reason, official guidelines state that special monitoring and a potential dose adjustment may be required when starting treatment for seniors.

Q: What does the evidence say about Enaladil's effectiveness in long-term clinical studies?

A: Studies and official information indicate that this medicine is associated with maintaining its blood pressure-lowering effects over long-term therapy. Clinical trials lasting more than one year have also described patterns of sustained benefits related to exercise tolerance and symptoms of heart failure.

Q: How long does it typically take for the full intended effect of Enaladil to become noticeable?

A: According to clinical pharmacology data, the onset of the blood pressure-lowering effect can begin within one hour, and the peak effect is usually reached within four to six hours. However, achieving the optimal and full reduction in blood pressure may require treatment over several weeks.

Q: How is the standard dosing range for Enaladil typically determined by prescribers?

A: The determination of the correct starting dose is based on the specific health condition being treated, such as heart failure or hypertension. Furthermore, official guidelines require consideration of the patient’s existing kidney function and whether they are currently taking diuretics.

Q: Does Enaladil commonly cause dizziness or affect a person's ability to drive or operate machinery?

A: Regulatory information warns that side effects such as dizziness or sleepiness may occur while taking this medicine. Regulatory guidelines contain a caution against driving or operating tools or heavy machinery until a person understands how the medication may affect them.

Q: What is the purpose of a Boxed Warning (Black Box Warning) in the context of a drug like Enaladil?

A: A Boxed Warning is a required regulatory statement intended to highlight the most serious safety risks associated with a medication. For Enaladil, this warning emphasizes the potential for severe, life-threatening swelling (Angioedema) and the risk of injury or death to a developing fetus (Fetal Toxicity).

Q: What research has been published regarding the use of Enaladil in pediatric patients?

A: The medicine is officially approved for the treatment of high blood pressure (hypertension) in pediatric patients aged one month and older. The official approval confirms that clinical data was reviewed and accepted by regulatory bodies to establish appropriate dosing based on the child's body weight.

Q: Is Enaladil the kind of medicine that must be taken at the exact same time every day?

A: Clinical data indicates that the therapeutic effects of the dose can last for at least 24 hours. While regulatory guidance does not typically mandate an exact minute-by-minute schedule, official information suggests that taking the medicine at a similar time each day can help maintain consistent drug levels in the body.

Q: Are there any major safety alerts that have been issued by regulatory bodies regarding Enaladil?

A: Official labeling prominently features mandatory regulatory alerts detailing severe and potentially life-threatening risks. These safety warnings include the potential for significant swelling of the face and throat (Angioedema) and warnings against use during the second and third trimesters of pregnancy (Fetal Toxicity).

Q: Can people with a history of allergic reactions to other drugs take Enaladil?

A: Official product information states that the medication is specifically contraindicated (prohibited) for individuals with a known history of an allergic reaction to any other medicine in the same class (ACE inhibitors). Use is also prohibited for those with a history of Angioedema (swelling).

Q: What are the most common reasons a dose of Enaladil is reduced?

A: Official dosage guidelines specify that the dose is often reduced for patients who have moderate to severe reduction in kidney function. Additionally, a lower dose is typically used when starting therapy for heart failure to help prevent a severe drop in blood pressure.

Q: What is the main reason doctors prescribe Enaladil?

A: According to the official regulatory documents, the primary approved uses for this medication are the treatment of high blood pressure (hypertension) and the management of symptomatic heart failure. These indications are based on extensive clinical data submitted to and reviewed by health authorities.

Q: Is Enaladil usually prescribed as a long-term or short-term treatment?

A: The medicine is classified as a long-acting agent, and research has demonstrated that its therapeutic effects continue during long-term maintenance therapy. It is typically prescribed to manage chronic health conditions like hypertension and heart failure over an extended period.

Q: Is there a risk of discontinuation effects if Enaladil is stopped suddenly?

A: Clinical pharmacology studies cited in official documents have investigated the effects of abruptly stopping the medication. These studies indicate that sudden withdrawal has not been associated with a rapid, rebound increase in blood pressure.

Q: Does Enaladil interact with common stimulants like caffeine?

A: Official regulatory documents do not list a specific drug-to-drug interaction between this medicine and caffeine. However, some regulatory-backed health advice suggests limiting caffeine intake if a person has high blood pressure, as caffeine may raise blood pressure and potentially counteract the intended effect of the medication.

Q: Are there warnings about combining Enaladil with common herbal supplements?

A: Official sources state that patients should inform their healthcare providers about all herbal products, supplements, and vitamins being taken. This is due to the fact that these products are often not rigorously tested for safety or potential interactions with prescription medicines.

Q: Is Enaladil classified as a controlled substance by government agencies?

A: The medication is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA) or similar international regulatory bodies. This means that government agencies do not track or regulate it as a substance with a high potential for abuse or dependence.

Q: How often does a person need monitoring while taking Enaladil?

A: Official guidelines require patients to undergo regular medical monitoring while on this medication. This monitoring typically involves checking blood pressure, kidney function (measured by serum creatinine), and blood electrolyte levels (measured by serum potassium).

Q: Are there specific instructions in the product labeling about whether Enaladil tablets can be crushed or split?

A: While specific instructions vary by brand, some product monographs advise against splitting the tablets. Regulatory guidance states that if a tablet is not explicitly scored (designed to be split), a person should consult a pharmacist, as non-scored halves have not been evaluated by regulators for equivalent dose.

Q: What is meant by the term pharmacokinetics when describing how the body handles Enaladil?

A: Pharmacokinetics is the regulatory term used to describe how the body processes the medication over time. This involves four main stages: how the drug is absorbed (about 60% bioavailable), how it is distributed, how it is broken down into its active form (enalaprilat), and how it is eliminated, primarily through the kidneys.

Q: What is the half-life of Enaladil as reported in official pharmacological descriptions?

A: The effective half-life of the active drug, enalaprilat, is reported as 11 hours following multiple doses. The half-life is a measurement used in regulatory science to describe the time it takes for the concentration of the medication in the body to be reduced by half.

Q: What are the most common reasons patients discontinue Enaladil therapy?

A: Regulatory reports on clinical trial results indicate that the most common side effects leading patients to stop therapy are usually a persistent cough and symptoms related to low blood pressure. These low blood pressure symptoms can include feeling dizzy or lightheaded.

How should Enaladil be stored and disposed of?

How to Store and Dispose of Enalapril (Enaladil)

Enalapril must be stored according to specific regulatory requirements to ensure its stability. Tablets require storage at controlled room temperature, specifically between 20°C to 25°C (68°F to 77°F), and must be protected from excessive moisture. The medication must always be stored in its tightly closed container and kept out of the sight and reach of children.

Stability and Disposal

The enalapril oral solution has a limited 60-day in-use period after dispensing, regardless of the expiration date, and must be discarded thereafter. For disposal of unused or expired medication, enalapril is not on the list of medicines recommended for flushing. The official guidance is to use a drug take-back program or, if unavailable, to mix the medicine with an unappealing substance, seal it, and discard it in the household trash.

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

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