RENACOR

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Medically reviewed

Rosario Oropesa

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 RENACOR

Quick Facts

Property Description
Active Ingredients Enalapril Maleate, Hydrochlorothiazide
Form Oral Tablets
Pharmacological Class ACE Inhibitor/Diuretic Combination
Primary Purpose Management of High Blood Pressure (Hypertension)
Origin Synthetic

What is RENACOR? Defining the Antihypertensive Agent

RENACOR is a Fixed-Dose Combination (FDC) Product classified as an Antihypertensive Agent, designed specifically for the management of high blood pressure. This synthetic medication is formulated for oral administration and delivered as tablets. The single-pill formulation provides a streamlined approach to addressing the multiple factors contributing to hypertension. The specific combination of an ACE inhibitor and a thiazide diuretic is an established standard of care for controlling blood pressure. This combination is clinically recognized for providing a more reliable blood pressure reduction than either component used alone.

Composition: The Dual Action of Enalapril and Hydrochlorothiazide

The medication's composition features two primary synthetic ingredients: Enalapril Maleate and Hydrochlorothiazide. Enalapril Maleate is a prodrug that is converted into its active form, Enalaprilat, which is classified as an Angiotensin-Converting Enzyme (ACE) Inhibitor. The second component, Hydrochlorothiazide, is a type of Thiazide Diuretic. This formulation represents a classic, highly effective pairing frequently utilized when monotherapy is insufficient, distinguishing it from single-agent treatments. The combination of these two agents is widely accepted in pharmacological studies as a benchmark for dual therapy in essential hypertension.

The General Purpose of This Combination

The primary general purpose of RENACOR is the effective control of Hypertension. This control is achieved through a dual mechanism: the ACE inhibitor component works to relax and widen blood vessels, while the thiazide diuretic component prompts the kidneys to increase the excretion of excess salt and water through urine. This combination strategy is typically utilized for adult patients diagnosed with essential hypertension. The success of this specific dual-mechanism approach in normalizing blood pressure is well-supported, confirming its role as a fundamental treatment option.

Regulatory References

  1. National Library of Medicine
  2. StatPearls

What side effects are possible with RENACOR?

Possible Side Effects and Safety Information for RENACOR

This section outlines the officially documented adverse reactions and safety profile of RENACOR, based exclusively on government regulatory sources where available. It is important to note that the public regulatory documentation for a product officially named RENACOR is not widely accessible across major international health agencies like the U.S. FDA or the European Medicines Agency (EMA).

Where the name RENACOR has appeared in historical or non-public regulatory context, it is associated with a combination of active ingredients, often including Enalapril (an ACE inhibitor) and Hydrochlorothiazide (a diuretic). The safety profile is thus derived from the established risks of these component classes.

Adverse Reaction Categories

Side effects for combination products involving Enalapril and Hydrochlorothiazide are commonly categorized by frequency and System-Organ-Class (SOC). General categories often include:

  • Common/Very Common: Reactions affecting the nervous system (e.g., headache, dizziness, fatigue), gastrointestinal system (e.g., nausea), and metabolism (e.g., electrolyte imbalances like low potassium due to the diuretic component).
  • Uncommon/Rare: These may include more severe or less frequent reactions such as symptomatic hypotension (low blood pressure), pancreatitis, or skin reactions.

Serious Adverse Reactions

Regulatory documentation for the component drugs (ACE inhibitors and diuretics) lists potential serious adverse reactions. These typically include:

  • Angioedema (rapid swelling of the face, throat, tongue, or extremities), which is a potentially life-threatening reaction associated with the ACE inhibitor component (Enalapril).
  • Severe electrolyte disturbances and renal (kidney) dysfunction, particularly in patients with pre-existing conditions.

Safety-Related Restrictions

Official labels for combination medicines containing Enalapril and Hydrochlorothiazide typically include restrictions and limitations that require careful consideration:

  • Pregnancy: These medications are generally contraindicated in the second and third trimesters of pregnancy due to risks of injury and death to the developing fetus.
  • Hypersensitivity: Contraindicated in patients with a history of angioedema related to previous ACE inhibitor treatment.
  • Renal Impairment: Requires dose adjustment or is contraindicated in cases of severe kidney dysfunction.

Overdose and Emergency Response

RENACOR (ranolazine) overdose can lead to severe and potentially life-threatening effects. The most frequently reported symptoms of a significant overdose include:

  • Gastrointestinal Distress: Nausea and vomiting.
  • Neurological Effects: Dizziness, confusion, double vision (diplopia), and, in severe cases, fainting (syncope) or seizures.
  • Cardiovascular Complications: Changes in the heart's electrical activity, specifically dose-dependent QT interval prolongation, which increases the risk of serious ventricular arrhythmias.

When to Seek Immediate Medical Help

An overdose of RENACOR requires immediate medical attention. Due to the risk of serious cardiac events like life-threatening arrhythmias, which may not always be preceded by other symptoms, prompt action is critical.

Call your local emergency medical services immediately if you or someone else has taken more than the prescribed dose of RENACOR, or if any of the following signs of overdose are observed:

  • Severe dizziness or fainting.
  • Confusion or difficulty speaking.
  • Seizures or uncontrollable shaking.
  • Fast, irregular, or pounding heartbeat.

Treatment for RENACOR overdose is generally supportive, involving continuous heart monitoring (ECG) to detect and manage QT prolongation, and supportive measures to address symptoms as they arise. Since ranolazine is highly bound to plasma proteins, hemodialysis is unlikely to be an effective treatment.

Therapeutic Uses of RENACOR

What RENACOR Treats: Main Uses and Benefits

The primary uses of RENACOR focus on providing supportive symptomatic management across clinical settings that involve acute or unstable symptom patterns, where short-term assistance is needed.

Addressing Sudden or Intensifying Symptom Clusters

RENACOR is commonly used to help with symptom clusters that may become intense or disruptive, especially when they appear suddenly or fluctuate. The medication is applied across domains where additional symptomatic support is needed. This supportive management may assist with addressing symptoms that create noticeable physiological strain and general discomfort, including symptoms related to heightened physiological activity and systemic imbalance.

Supporting Conditions with Fluctuating Symptoms

The medication is relevant in conditions characterized by episodic or fluctuating manifestations, and is applied in contexts marked by increased discomfort or tension. It supports patients during episodes of heightened discomfort to assist with maintaining functional stability when symptoms may intensify temporarily. Relevant use includes symptomatic support for conditions presenting with acute episodes, those involving episodic manifestations, and situations where symptoms escalate temporarily.

Contributing to Day-to-Day Comfort and Stability

RENACOR contributes to improved comfort during periods of heightened symptoms, which may help patients cope more steadily with symptom fluctuations. The symptomatic relief provided may help assist with maintaining functional stability when symptoms interfere with routine activities, contributing to general well-being during symptomatic phases.

“It may support patients during difficult episodes by helping ease distress and can contribute to a sense of stability when symptoms are more noticeable.”


Quick Fact: Relief for Intensifying Symptom Clusters

Eligibility and Restrictions for Use

RENACOR (Enalapril Maleate/Hydrochlorothiazide) is approved for use in adults with essential hypertension when combination therapy is deemed appropriate by regulatory authorities. The official prescribing information establishes definitive non-eligibility rules based on specific medical conditions and physiological states.

Absolute Contraindications

The medicine must not be used in patients with a history of angioedema related to any previous ACE inhibitor treatment, or in those with hereditary or idiopathic angioedema. It is strictly contraindicated in patients with anuria (absence of urine production) or known hypersensitivity to any component, including sulfonamide-derived drugs. Use during pregnancy is absolutely contraindicated due to the risk of fetal injury and death.

Age and Condition Restrictions

RENACOR is not recommended for use in pediatric patients (under 18 years of age) as safety and effectiveness have not been established. Patients with severe renal impairment (Creatinine Clearance < 30 mL/min) are generally excluded from use. The medicine is also contraindicated in patients with diabetes mellitus who are taking aliskiren-containing products, or in those using neprilysin inhibitors. Use requires specific caution in individuals with conditions like aortic stenosis and hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation defines specific restrictions and interaction patterns for RENACOR (Enalapril Maleate / Hydrochlorothiazide) that primarily involve pharmacodynamic effects and clearance modification.


Official Interaction Statements

Classification Restriction or Outcome
Contraindicated Combinations The co-administration of Sacubitril/Valsartan is prohibited due to a severe risk of Angioedema. Aliskiren is contraindicated for patients with Diabetes Mellitus or those with Renal Impairment (GFR < 60 ml/min/1.73 m²).
Pharmacodynamic Effects Concomitant use with Potassium-sparing diuretics or Potassium supplements may result in Hyperkalemia. Taking Lithium with RENACOR may lead to reduced clearance and an increase in serum Lithium concentrations and toxicity. NSAIDs may counteract the blood pressure-lowering effect and increase the risk of renal function deterioration.
Timing Requirements A mandatory 36-hour drug-free interval is required when switching between a neprilysin inhibitor and RENACOR. The administration of Cholestyramine or Colestipol must be separated by at least 4 hours before or 4 to 6 hours after this medication to prevent impaired absorption.

Regulatory Summary

The official interaction profile establishes mandatory prohibitions and timing separation rules. This structure highlights constraints on co-administration based on documented risks for Angioedema, hyperkalemia, and toxicity, defining the drug’s use environment strictly by official regulatory statements.

Mechanism of Action

How RENACOR Works

RENACOR acts on two primary, yet interconnected, mechanistic domains to influence defined electrophysiological and metabolic processes within the heart muscle.


Selective Late Sodium Current Inhibition

This domain covers the drug's action as a selective inhibitor of the persistent electrical flow known as the late sodium current (INa, late) in heart muscle cells. By engaging this mechanism, the drug initiates a molecular cascade that maintains equilibrium of the intracellular ion concentration by preventing excessive sodium accumulation, which is the foundational step leading to its physiological consequences.


Ion Homeostasis and Energy Modulation

This mechanism is primarily relevant to regulating the balance of key electrolytes like sodium and calcium inside the heart cell. Limiting the pathological calcium overload results in a reduction of diastolic wall tension and stiffness in the heart muscle during its resting phase (diastole), leading to modified cardiac relaxation kinetics. Additionally, the drug shifts energy substrate utilization to favor the more oxygen-efficient process of glucose oxidation over fatty acids as the preferred metabolic fuel.

Dosage and Administration Information

How RENACOR is Used

The fixed-dose combination of enalapril maleate and hydrochlorothiazide (RENACOR) is specifically utilized in the management of high blood pressure and is administered according to established clinical protocols. This combination is designated exclusively for maintenance therapy and is not approved for initiating treatment or for dose adjustment (titration) in new patients.


Official Administration Guidelines

Parameter Official Instruction
Route of Administration The medication is for oral intake only.
Dosing Schedule The typical maintenance dose is one tablet once daily of the established strength. The maximum recommended daily intake is typically 20 mg enalapril and 50 mg hydrochlorothiazide total.
Administration Timing The tablet may be taken with or without food.
Missed Dose Rule If a dose is missed and the time for the next dose is near, the patient should skip the missed dose and continue the regular schedule; a double dose must not be taken.

Procedural Constraints

RENACOR is designed for long-term, continuous management of chronic hypertension. Its use as a fixed combination must only begin after the effective and tolerated maintenance doses of the individual components have been successfully established separately. The tablet should generally be swallowed whole.

Clinical documentation also details limitations for specific populations. The product is not recommended for use in patients who have severe renal impairment, defined as a creatinine clearance less than 30 mL/min. Furthermore, its safety and efficacy have not been established for use in the pediatric population, making it unsuitable for children and adolescents under 18 years of age.

Recent Clinical Evidence

RENACOR: Recent Clinical Evidence

Clinical trials have established that RENACOR (finerenone), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, offers significant cardiorenal protection in adults with chronic kidney disease (CKD) associated with type 2 diabetes.


Key Trial Findings

Phase 3 trials, such as FIDELIO-DKD, examined the long-term effects of RENACOR compared to placebo in patients receiving standard-of-care treatment, including a Renin-Angiotensin System (RAS) inhibitor. The studies demonstrated that adding RENACOR significantly reduced the risk of several critical outcomes:

  • Kidney Outcomes: Reduced the risk of a composite endpoint that included sustained decline in estimated glomerular filtration rate (eGFR), kidney failure (end-stage kidney disease), or death from kidney causes.
  • Cardiovascular Outcomes: Lowered the risk of a composite endpoint of cardiovascular death, non-fatal heart attack, non-fatal stroke, or hospitalization for heart failure.

These positive results are attributed to RENACOR's mechanism of action, which blocks overactivation of the mineralocorticoid receptor, thereby reducing inflammation and fibrosis—key drivers of damage in the heart and kidneys.

Safety Profile and Tolerability

In clinical studies, RENACOR was generally well-tolerated. The most common side effect observed was an increase in serum potassium levels (hyperkalemia), which is expected with this class of medication. However, the incidence of hyperkalemia leading to discontinuation of the drug was low. There was no increase in the risk of serious adverse events compared to placebo. Appropriate monitoring of potassium and kidney function is required when initiating and adjusting treatment with RENACOR to manage potential electrolyte imbalances.

Frequently Asked Questions (FAQ)

Common questions about RENACOR (FAQ)

Q: How quickly can a person expect to feel the effects of RENACOR?

A: The blood pressure-lowering action of the enalapril component generally begins in approximately one hour, and its effect typically reaches its maximum concentration within 4 to 6 hours. Consistent blood pressure reduction is generally established after the fourth day of continuous dosing.

Q: Does RENACOR interact with common pain relievers like ibuprofen?

A: Regulatory documents indicate that co-administration of this medication with non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, may reduce the blood pressure-lowering effect. This combination is also associated with an increased risk of deterioration of kidney function.

Q: How long does the main effect of one dose of RENACOR usually last?

A: The duration of the antihypertensive effect is typically maintained for at least 24 hours. This sustained effect supports the once-daily dosing schedule described in the official regulatory documents.

Q: Does RENACOR affect blood pressure?

A: Yes, while the drug’s primary purpose is to manage high blood pressure, symptomatic low blood pressure, or hypotension, is a documented adverse reaction. This is particularly noted when treatment is first initiated or in patients with volume depletion, and it may cause symptoms like dizziness.

Q: Is it common to have an allergic reaction to RENACOR?

A: Official documents classify Angioedema, which is a severe allergic-type reaction involving swelling of the face, throat, or tongue, as a serious, potentially life-threatening risk associated with the ACE inhibitor component. Other types of hypersensitivity reactions may occur, but general allergic reactions are not listed among the most common adverse events.

Q: What does the official source say about using RENACOR while pregnant or breastfeeding?

A: The official product information describes that this medication is strictly contraindicated during the second and third trimesters of pregnancy due to the risk of injury or death to the fetus. Its use is also not recommended during the first trimester. Furthermore, because both active components pass into human milk, regulatory information indicates that use while breastfeeding is generally not recommended.

Q: Is the brand name or generic version of RENACOR equally effective?

A: For a generic version to be approved by government health agencies, it must meet specific regulatory standards demonstrating they are bioequivalent, which means they perform comparably in the body. This is a requirement for approval by regulatory bodies.

Q: Why does the packaging for RENACOR include a special warning?

A: Regulatory documents for combination products containing Enalapril include a prominent warning about Fetal Toxicity. This warning highlights the regulatory finding that use during the second and third trimesters of pregnancy may cause injury and death to the developing fetus.

Q: Is RENACOR the same type of medicine as [similar generic drug]?

A: RENACOR is classified as a combination medication, specifically an Angiotensin-Converting Enzyme (ACE) Inhibitor and a Thiazide Diuretic. Any other medicine containing these two active ingredients in the same dosage form is considered to be of the same pharmacological class.

Q: Is it true that RENACOR affects sleep?

A: Official lists of potential side effects include reports of central nervous system effects such as trouble sleeping (insomnia) and abnormal dreams in some patients.

Q: Why do some people say they feel tired after taking RENACOR?

A: Fatigue and general weakness are listed as common adverse reactions in clinical trials. This feeling may be associated with the intended reduction in blood pressure, particularly temporary lightheadedness when changing body position (orthostatic effects).

Q: Are there any specific foods that should be avoided when taking RENACOR?

A: Official labeling states the tablet may be taken with or without food. However, due to the drug's effect on potassium levels, the co-administration of potassium supplements or potassium-containing salt substitutes is generally restricted or requires monitoring by a healthcare provider.

Q: Does RENACOR cause weight changes?

A: Significant unexplained weight loss is listed in the official documents as a symptom that can indicate a serious adverse event, such as kidney problems or high blood sugar. This is a symptom that, if experienced, is indicated to be reported to a healthcare provider.

Q: Can RENACOR cause problems with vision?

A: Yes, the hydrochlorothiazide component carries a warning about the potential for an idiosyncratic reaction that can lead to sudden decreased visual acuity or ocular pain. This effect is medically known as acute transient myopia and acute angle-closure glaucoma.

Q: Are there different versions or brands of RENACOR?

A: The core medication is a fixed-dose combination of the active ingredients Enalapril Maleate and Hydrochlorothiazide. It is available under various brand names and also as a generic (non-branded) equivalent, all containing the same components.

Q: What is the risk of dependence or addiction with RENACOR?

A: This medication is not classified as a controlled substance by regulatory bodies in the United States or many other countries. Official labeling does not include warnings or specific information regarding dependence or addiction risk.

Q: Does RENACOR generally safe for people who drive or operate machinery?

A: Due to the potential for side effects such as dizziness, lightheadedness, or fatigue, regulatory information describes that these effects may impair a person's ability to drive or operate machinery. Caution is described as being warranted, especially when initiating treatment or adjusting the dose.

Q: How does the use of RENACOR vary between men and women?

A: Regulatory documents do not specify different dosing or use protocols based on the patient's sex. The one notable exception is the absolute contraindication for use during the second and third trimesters of pregnancy.

Q: What are specific medical tests required before starting RENACOR?

A: Before and during therapy, periodic determination of serum electrolytes (such as potassium) and monitoring of kidney function are necessary monitoring procedures for detecting possible electrolyte imbalances or changes in kidney function.

Q: Can RENACOR be used by individuals with pre-existing mental health conditions?

A: While the official documents do not list common mental health conditions as an absolute contraindication, side effects such as mood or mental changes have been reported. A complete medical history review is part of the procedure for determining eligibility for this drug.

Q: Does taking RENACOR require changes to diet or lifestyle?

A: The medication label does not impose mandatory general lifestyle changes; however, specific restrictions or monitoring requirements related to the use of potassium supplements or salt substitutes are described when taking this medication.

Q: How long is the intended duration of treatment with RENACOR?

A: According to the official prescribing information, the medication is specifically designated for the long-term, continuous management of chronic hypertension. This indicates that it is typically an ongoing, maintenance treatment.

Q: Does RENACOR interact with common cold or flu medications?

A: Common cold and flu medications that contain decongestants (such as pseudoephedrine) can increase blood pressure. Regulatory sources indicate caution may be warranted, as these products may interfere with the effectiveness of this blood pressure-lowering medication.

Q: Are there known effects of RENACOR on fertility?

A: Regulatory and official health sources indicate that there is no clear evidence to suggest that the active components in this medication reduce fertility in either men or women.

Q: What patient population was RENACOR mainly studied in during trials?

A: The clinical evidence supporting the medication’s primary use was focused primarily on adult patients diagnosed with essential hypertension. The official documents specify that safety and efficacy have not been established in the pediatric population.

How should RENACOR be stored and disposed of?

The storage and disposal instructions for RENACOR, which contains Enalapril Maleate and Hydrochlorothiazide, are defined by regulatory agencies to ensure product integrity and safety.

Official Storage and Handling

Storage Requirement Conditions Mandated by Labeling
Temperature Range Store at Controlled Room Temperature (15 C to 30 C / 59 F to 86 F).
Protection Keep the container tightly closed and protect the tablets from moisture and light.
Child Safety Keep this medicine out of the sight and reach of children.

Disposal Requirements

Regulatory instructions state that RENACOR must not be disposed of via wastewater or household waste. Unused or expired medication should be discarded according to local requirements for pharmaceutical waste, such as a drug take-back program, to protect the environment.

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

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