Erefil

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Medically reviewed

Marina Burgos

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 Erefil

Erefil is a prescription-only medication classified as a vasoactive agent, formulated for oral administration and defined by its single active ingredient, Sildenafil.

Property Description
Active ingredient Sildenafil (typically as the citrate salt)
Form Oral formulation (Tablets)
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
Common use Modulation of regional blood flow
Origin Synthetic chemical compound

What Type of Medicine is Erefil?

Erefil belongs to the Phosphodiesterase type 5 (PDE5) inhibitor class of drugs. This classification describes the drug's core mechanism: it acts as a selective inhibitor of the cGMP-specific PDE5 enzyme. The drug is clinically recognized for providing predictable modulation of vascular tone in specific physiological contexts. Erefil, like its Sildenafil counterparts, is a non-naturally occurring synthetic chemical compound.

Sildenafil: Composition and Physical Form

The pharmacological activity of Erefil is driven entirely by its active ingredient Sildenafil, making it a single product where the therapeutic action is centralized on this compound. It is manufactured as an oral formulation presented as tablets for easy oral administration. The use of the tablet form is a practical differentiator for patients seeking simplicity in oral intake. The therapeutic activity of Sildenafil occurs because it augments the endogenous nitric oxide signaling pathway, thereby restoring vascular responsiveness.

General Purpose as a Vasoactive Agent

The general physiological purpose of Erefil is to promote controlled, localized vasodilation, which involves the relaxation and widening of specific blood vessels. This effect is achieved because Sildenafil prevents the rapid breakdown of the natural signaling molecule cGMP, leading to the potentiation of cGMP and subsequent smooth muscle relaxation. By modulating the Nitric Oxide (NO) signaling pathway, Erefil successfully enhances regional blood flow characteristics, solidifying its classification as a focused and powerful vasoactive agent typically used where improved circulatory function is required.

What side effects are possible with Erefil?

Possible Side Effects and Safety Information

The safety profile of Erefil (Sildenafil) is defined by officially documented adverse reactions classified by frequency and grouped by the body system affected, based on regulatory standards.

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to incidence observed in clinical data, with effects primarily related to the drug's vasoactive properties.

Frequency Example Adverse Reactions (System-Organ Class)
Very Common Headache (Nervous System)
Common Flushing (Vascular), Dyspepsia (Gastrointestinal), Abnormal Vision (Ocular), Nasal Congestion (Respiratory)
Rare Priapism (Prolonged Erection), NAION (Sudden Vision Loss), Seizure (Nervous System)

System-Organ Class Groupings and Serious Reactions

The most frequently reported adverse reactions, such as Headache and Flushing, tend to occur more prominently during the initial phase of treatment.

Officially documented serious adverse reactions include Non-arteritic Anterior Ischemic Optic Neuropathy (NAION), a sudden decrease or loss of vision, and Priapism, an erection lasting longer than four hours. Sudden Hearing Loss has also been noted in regulatory documents.

Safety-Related Restrictions and Considerations

Sildenafil is strictly contraindicated for use with Nitrates or Nitric Oxide donors due to the high risk of severe hypotension. Safety notes also advise against use in patients with a history of NAION in one eye or severe cardiovascular conditions where physical activity is inadvisable. Systemic drug exposure is documented to be significantly increased in older adults, and in patients with severe renal or hepatic impairment, necessitating specific clinical focus for these populations.

Overdose and Emergency Response

Erefil overdose is officially defined in regulatory documents by the increase in the frequency and severity of the drug’s known adverse events. Observed clinical manifestations typically involve an amplification of common effects, such as headache, flushing, and dyspepsia, which were noted in studies using single doses significantly higher than the maximum recommended amount.

When overdose is suspected, official guidance mandates that the patient or caregiver seek emergency medical attention immediately. Severe outcomes linked to the drug's pharmacological activity require specific, urgent intervention. For instance, priapism, defined as an erection lasting longer than four hours, or sudden loss of vision, require the medication to be stopped and immediate medical help to be sought. The risk of severe hypotension is also a documented concern resulting from an amplified vasodilatory effect.

In a confirmed overdose situation, management is strictly limited to symptomatic and supportive treatment, as regulatory sources state that no specific antidote is known. The official profile also includes a critical population-specific note: there is a documented warning regarding an increased mortality risk associated with increasing doses in pediatric patients who are being treated for pulmonary hypertension.

Therapeutic Uses of Erefil

What Erefil Treats: Main Uses and Benefits

Erefil (Sildenafil) is utilized in therapeutic areas that involve certain distressing symptoms related to compromised blood flow. The medication is used to help manage conditions such as Erectile Dysfunction (ED) in adult men, Pulmonary Arterial Hypertension (PAH) in adult and pediatric patients, and is also applied in addressing symptoms in situations involving recurrent or episodic manifestations of severe vasospasm.

Erefil is commonly applied in clinical settings that involve acute or unstable symptom patterns, such as managing the functional symptoms of ED and supporting physical function during chronic PAH. The medication generally provides supportive relief, which contributes to easing the overall symptom load. This supports general well-being during symptomatic phases and may help patients cope more steadily with symptom fluctuations.


Quick Fact: Support in Managing Functional Strain

Erefil is relevant for easing symptom clusters that may become intense or disruptive, often associated with conditions that present with systemic or localized discomfort. It is applied in scenarios where supportive symptom management is appropriate to help improve day-to-day comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Erefil (Sildenafil) is a prescription-only medication whose use is strictly defined by regulatory eligibility criteria regarding a patient’s health status and age.

Populations for Whom Use is Contraindicated

Erefil must not be used in patients taking any form of organic nitrates (nitroglycerin) or nitric oxide donors, or those using Guanylate Cyclase (GC) Stimulators (Riociguat), due to the severe risk of hypotension. It is also prohibited for patients with a known hypersensitivity to Sildenafil.

Contraindications based on health status include severe hepatic impairment and resting hypotension (blood pressure <90/50 mmHg). The medicine is also officially contraindicated for patients with a recent history of stroke or myocardial infarction (within the last six months) and those with specific hereditary degenerative retinal disorders.


Age and Organ Function Eligibility Rules

Population Group Eligibility Status Notes (Regulatory Basis)
Pediatric Patients (le 17 years) Not indicated for Erectile Dysfunction Approved for Pulmonary Arterial Hypertension (PAH), but chronic use is subject to specific regulatory warnings.
Older Adults (ge 65 years) Conditional Use A lower starting dose may be advised due to age-related reduced clearance.
Severe Renal Impairment Conditional Use A lower starting dose may be advised due to reduced drug clearance.
Pregnancy / Lactation Safety Not Established Use for PAH is assessed on a risk/benefit basis due to risks from untreated PAH.

Use of Erefil is not indicated for women seeking treatment for the Erectile Dysfunction indication. These limitations define the conditions under which the drug can be officially prescribed.

What should I know about interactions with other medicines?

Erefil Interactions with other medicines and products

The regulatory profile for Erefil (Sildenafil) identifies specific interaction patterns that necessitate restrictions or dose considerations.

Contraindicated Combinations

Co-administration is strictly prohibited with medicinal products that pose a high risk of severe hypotension due to additive vasodilatory effects. This includes all forms of organic nitrates and nitric oxide donors. Co-administration is also contraindicated with the Guanylate Cyclase (GC) Stimulator Riociguat.


Pharmacokinetic and Exposure Interactions

Erefil clearance is subject to modification by the CYP3A4 enzyme system. Co-administration with strong CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole) causes a significant increase in Sildenafil plasma exposure (AUC). Conversely, strong CYP3A4 inducers (e.g., Rifampin, Bosentan) are documented to decrease Sildenafil plasma concentrations.


Other Documented Interactions

  • Alpha-Blockers (Pharmacodynamic): Use with alpha-blockers may result in additive blood pressure lowering effects. Regulatory labeling advises that patients must be stable on alpha-blocker therapy prior to initiating Erefil.
  • Food and Supplements: Taking the medicine immediately after a high-fat meal is documented to delay its rate of absorption. The official profile notes that grapefruit juice may modestly increase exposure, and excessive alcohol consumption may increase the risk of hypotension.

Mechanism of Action

Inhibition of the PDE5 Enzyme and cGMP Potentiation

The mechanism of action for Erefil, driven by its active ingredient Sildenafil, begins with the selective inhibition of the Phosphodiesterase type 5 ( PDE5) enzyme. This targeted enzyme blockade prevents the rapid metabolic breakdown (hydrolysis) of cyclic GMP ( cGMP), a crucial second messenger molecule. By protecting cGMP, the drug potentiates and prolongs the duration of the body's natural Nitric Oxide ( NO) signal, which is responsible for initiating cGMP production.


Causal Cascade to Vascular Smooth Muscle Relaxation

The resulting accumulation of cGMP within cells initiates a molecular cascade that leads to the activation of cGMP-dependent protein kinase ( PKG). This activation promotes the reduction of intracellular calcium ion ( Ca^2+) concentrations in the vessel walls. The physiological consequence of this calcium reduction is vascular smooth muscle relaxation, a process that modulates peripheral vascular tone.


Localized Vasodilation and Increased Regional Blood Flow

The relaxation of smooth muscle in the arteries causes localized vasodilation (vessel widening). This mechanism results in a change in regional blood flow in targeted vascular beds. It is critical to note that Erefil's mechanism is Nitric Oxide-dependent, meaning the drug only amplifies an existing physiological signal; it does not initiate the process if the upstream NO signal is absent.

Dosage and Administration Information

How to Use Erefil

Erefil (Sildenafil) is administered according to two distinct usage protocols that govern its route, dose, and frequency based on the indication. The medication is available for oral use as tablets or a reconstituted suspension, with an intravenous (IV) injection form reserved for use in specific, acute settings.

Feature Use Pattern
For Erectile Dysfunction (ED) Used on-demand (as needed). The initial oral dose is 50 mg, which may be adjusted from 25 mg to a maximum of 100 mg per day. The dose should be administered approximately one hour prior to activity.
For Pulmonary Arterial Hypertension (PAH) Used on a scheduled, continuous regimen. The standard oral dose is 20 mg, taken three times daily (TID), with doses separated by approximately four to six hours, and can be escalated up to 80 mg TID

Administration Constraints and Adjustments

Administration with a high-fat meal may delay the absorption rate and the onset of action for ED use. Standard protocols include the consideration of a lower 25 mg starting dose for ED in older adults (ge 65 years) and those with severe renal or hepatic impairment due to anticipated changes in clearance.

For patients using the liquid oral suspension for PAH, it must be reconstituted and measured with a calibrated device. If a scheduled PAH dose is missed, standard procedure involves taking the next dose at the regular time, without taking a double dose.

Recent Clinical Evidence

Research evidence / Overview of studies for Erefil

Evidence for Use in Erectile Dysfunction (ED)

The research base for the use of Sildenafil (the active ingredient in Erefil) in Erectile Dysfunction (ED) is large in volume. The core evidence comes from numerous short-term (4 to 12 weeks) Randomized Controlled Trials (RCTs), supported by extensive meta-analyses and longer open-label extension studies (up to 1 year). These studies were used in research exploring how symptoms change over time and how they compare against an inactive treatment (placebo). Researchers applied validated questionnaires, focusing on functional outcomes such as the ability to achieve and maintain an erection adequate for sexual activity.

Studies monitored large populations of adult men with ED stemming from various causes, including those with other health concerns like diabetes mellitus and high blood pressure. Findings describe patterns observed in these studies where participants reported outcomes measured during the short study period. The evidence base is characterized by a large number of trials where the reported patterns were consistent related to these short-term, patient-reported outcomes.


Evidence for Use in Pulmonary Arterial Hypertension (PAH)

Erefil was also evaluated in research exploring its role in Pulmonary Arterial Hypertension (PAH), a condition marked by functional limitations related to blood flow in the lungs. Research for this indication primarily involved Randomized Controlled Trials (RCTs) lasting up to 16 weeks.

Studies explored key outcomes related to daily functioning or activity level, most notably the 6-Minute Walk Distance (6MWD), which was used to monitor physiological strain or stress during exercise. Research also examined outcomes related to the time elapsed before a patient's condition showed clinical worsening. However, research tracking long-term patient survival, findings were mixed across different study designs and follow-up periods.


Key Research Gaps and Areas of Uncertainty

The certainty remains low when discussing long-term effects beyond one year for the functional outcomes measured in the ED trials, as follow-up durations were limited.

For PAH, while short-term functional outcomes were well-studied, data related to long-term survival remains mixed in the existing research. Additionally, findings were mixed in investigational research contexts, such as for Secondary Raynaud's Phenomenon, where the evidence quality varies across studies, and results apply only to the small populations studied.

Key Studies & References

  1. Sildenafil Oral: MedlinePlus Drug Information (NIH/NLM official patient-friendly summary of approved uses)
  2. Efficacy and safety of sildenafil in children with pulmonary arterial hypertension: a randomized controlled trial (STARTS-1)

Frequently Asked Questions (FAQ)

Common questions about Erefil (FAQ)


Q: Is Erefil a brand name or the generic name of the medicine?

A: The active ingredient in this medication is Sildenafil, which is the generic name for the compound. Erefil is a brand name used to market this specific medicine. Official documentation consistently uses Sildenafil when discussing the drug’s core properties.


Q: Is Erefil typically considered a short-term or long-term treatment?

A: The duration of treatment depends entirely on the condition being addressed. For some uses, the medication is taken on an as-needed basis only. For other conditions, official guidance describes a scheduled, continuous regimen. Long-term studies have been conducted to assess the medication's continued effectiveness and tolerability over several years in certain populations.


Q: How quickly does Erefil usually start to show its effects?

A: According to the official product information, the onset of the medication's effects is generally rapid. For on-demand use, the window of opportunity for efficacy typically begins approximately 30 minutes after administration. This timeline may be influenced by factors such as food intake.


Q: What is the expected duration of action for a single dose of Erefil?

A: Official regulatory labeling describes a therapeutic window for a single dose that is generally maintained for up to 4 to 5 hours from the time of administration.


Q: How is Erefil eliminated or cleared from the body?

A: The medication is primarily cleared from the body through hepatic metabolism, meaning it is broken down by the liver. This process is mainly carried out by a specific liver enzyme system known as Cytochrome P450 (CYP) 3A4.


Q: Does Erefil commonly cause weight changes or appetite issues?

A: Official documentation indicates that metabolic side effects, such as increased weight and fluid retention, have been reported. These effects are classified as uncommon to common.


Q: Is it true that Erefil can affect a patient's sleep or cause drowsiness?

A: Official safety profiles indicate that effects on sleep have been reported. Side effects such as trouble sleeping (insomnia) and, less commonly, drowsiness (somnolence) have been noted in documentation.


Q: Are there known long-term side effects that have been examined in studies on Erefil?

A: Studies extending up to four years have examined the tolerability of continuous use. The official findings indicate that the most common treatment-related side effects over the long term were consistent with short-term use, primarily headache and indigestion (dyspepsia).


Q: Does Erefil interact with common over-the-counter pain medications, like ibuprofen?

A: Official regulatory labeling requires specific warnings for drug classes that cause known, severe interactions, such as Nitrates. There is no specific warning listed in the official interaction documents regarding the concurrent use of over-the-counter Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like ibuprofen.


Q: What interactions are listed between Erefil and popular herbal or dietary supplements?

A: Official patient information advises that it is not possible to confirm the safety of all herbal remedies and supplements when taken with this medication, as they are not tested in the same way as prescription drugs. However, the consumption of grapefruit juice is specifically noted as it may affect the blood levels of the medication and is often advised to be avoided.


Q: Can Erefil be taken with other prescription medications used for chronic conditions?

A: The medication is strictly prohibited for use with certain drugs, such as Nitrates and Riociguat. For other chronic medications, such as some blood pressure-lowering drugs, regulatory guidance advises caution, careful monitoring, and potentially a lower starting dose due to potential additive effects.


Q: Are there public summaries of the clinical trials that led to Erefil's approval?

A: Public summaries of the clinical research that led to the medication’s approval are available. Findings from the clinical trials are summarized in peer-reviewed scientific literature and reviews that are accessible through government-run resources such as the National Institutes of Health (NIH).


Q: Is Erefil a controlled substance or does it have potential for abuse?

A: According to regulatory classifications, this medication is not listed as a controlled substance under the Controlled Substances Act (CSA). The medication is not generally associated with a high physical abuse potential.


Q: Is Erefil addictive or habit-forming?

A: Official pharmacological profiles indicate that the medication is not physically addictive or habit-forming. Because of this, it is not known to cause physical withdrawal symptoms upon discontinuation.


Q: What is the risk of experiencing an allergic reaction to Erefil?

A: The medication is contraindicated (must not be used) if a patient has a known hypersensitivity to Sildenafil, the active ingredient. Signs of an allergic reaction may include rash, hives, or swelling of the face, lips, or tongue.


Q: Does Erefil have an effect on a person's mood or mental clarity?

A: While not common, regulatory compilations list effects such as anxiety and mental depression as rare side effects. Other less common effects noted include confusion and difficulty in concentrating.


Q: Is it necessary to have routine monitoring tests (like blood work) while taking Erefil?

A: Routine monitoring tests, such as regular blood work, are generally not required when taking this medication alone. However, monitoring of blood pressure is advised when it is taken alongside certain other medications, such as those that lower blood pressure, due to the drug’s vasodilatory effects.


Q: Does Erefil affect liver enzyme levels as listed in the warnings?

A: Although uncommon, regulatory safety profiles have noted rare instances of clinically apparent liver injury. This injury has been associated with changes in serum enzyme elevations (blood tests that measure liver function).


Q: Is it possible for a person to develop a tolerance to Erefil over time?

A: Studies that have followed patients for up to four years found results that indicate the medication’s efficacy is maintained and argue against the development of a tolerance or a significant loss of effectiveness over that study period.


Q: What is the difference between Erefil’s active ingredient and the inactive ingredients?

A: The active ingredient (Sildenafil) is the substance responsible for providing the therapeutic effect. The inactive ingredients (like fillers, binders, and colorants) are substances included to help manufacture the tablet, ensure stability, and give it its final form, but they do not contribute to the medical effect.


Q: Can Erefil cause a false positive result on any common drug screening tests?

A: The medication’s active compound, Sildenafil, is not typically included in standard drug screening panels. The likelihood of Erefil causing a false positive result on common screening tests is considered extremely low.


Q: What does regulatory labeling say about driving or operating machinery while taking Erefil?

A: Official regulatory patient information advises caution when engaging in potentially hazardous activities. Because the medication can cause side effects such as dizziness, abnormal vision, or visual disturbance, official guidance cautions against driving or operating machinery if these specific effects are experienced.


Q: Is it generally accepted that Erefil tablets can be crushed or split?

A: The product is provided as film-coated tablets. Regulatory standards generally state that tablets are not intended to be crushed or split to administer a fraction of a dose, as altering the dosage form may affect how the drug is absorbed. Liquid forms of the medication are available for certain indications where alternative administration is necessary.

How should Erefil be stored and disposed of?

Erefil (Sildenafil) must be stored according to specific conditions detailed in official regulatory labeling to ensure product stability and safety. The tablets require storage at controlled room temperature, specifically 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C (86 F).

The product must be kept in the original container and the lid or closure must remain tightly closed to protect it from moisture. It is a mandatory requirement to store Erefil and all medicines out of the sight and reach of children.

Unused or expired Erefil should be disposed of properly through local drug take-back programs or official government-approved disposal methods. The product should not be disposed of by flushing it down the toilet.

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

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