Erosfil

Quick links to important sections

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 Erosfil

Property Description
Active ingredient Sildenafil Citrate
Form Primarily oral tablets
Pharmacological class Selective Phosphodiesterase Type 5 (PDE5) Inhibitor
General utility Enhances local blood flow and relaxation
Origin Synthetic organic compound

Erosfil: Definition and Pharmacological Classification

Erosfil is a representative pharmaceutical preparation containing the active chemical entity Sildenafil Citrate. This compound is classified under the pharmacological category of a selective Phosphodiesterase Type 5 (PDE5) inhibitor. This classification confirms the drug's specialized role in modulating a specific biological enzyme. The identity of Erosfil as a potent PDE5 inhibitor is recognized for its predictable performance in facilitating vascular responses. The Sildenafil substance was notably the first orally bioavailable compound of its class approved for medical use, establishing a new therapeutic benchmark in functional management.

Composition, Origin, and Available Forms

Sildenafil Citrate, the functional element of the medication, is a meticulously manufactured synthetic organic compound that guarantees consistent pharmacological action. Erosfil is functionally a monotherapy, focusing solely on the effects of Sildenafil, unlike formulations that might combine active ingredients. Its most common presentation is as an oral solid preparation (tablets), typically intended for adult patients. However, the compound is also utilized in specialized preparations, such as those intended for intravenous administration, which allows for flexibility in clinical use. This broad availability across multiple forms relates to the consistent systemic efficacy of the Sildenafil compound.

Core Function and General Therapeutic Utility

The central function of Erosfil is to promote smooth muscle relaxation within blood vessel walls through the selective inhibition of the PDE5 enzyme. This action prevents the rapid degradation of cyclic guanosine monophosphate (cGMP), a key signaling molecule. By sustaining elevated cGMP levels, the drug amplifies the body’s natural relaxation signals. The resulting vasodilation facilitates an increase in local blood flow, which is the fundamental mechanism defining the drug's general utility in managing impaired circulatory function.

What side effects are possible with Erosfil?

Possible Side Effects and Safety Information

The safety profile of Erosfil (Sildenafil Citrate) is categorized in official regulatory documents based on the frequency and system-organ class affected. This section is strictly descriptive and not intended as medical advice or instruction.


Documented Adverse Reactions

Adverse reactions are classified by incidence as stated in official regulatory labels, primarily affecting the Nervous System and Vascular Disorders.

Classification Common Examples (from regulatory reports)
Very Common (>1 in 10) Headache, Flushing
Common (up to 1 in 10) Dizziness, Dyspepsia, Nasal Congestion, Vision Color Distortion/Blurred Vision
Uncommon (up to 1 in 100) Hypersensitivity reactions, Tachycardia, Vomiting, Rash

Serious Safety Considerations

Official labeling highlights several serious adverse reactions, which, while rare, are critical safety components. These include cases of Prolonged Erection (Priapism), sudden decrease or loss of vision due to Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION), and documented cardiovascular events (e.g., myocardial infarction, sudden cardiac death) often reported in a temporal relationship to use and/or sexual activity.

Safety Restrictions and Limitations

Administration of Erosfil is strictly contraindicated in patients receiving any form of organic nitrates or nitric oxide donors due to the risk of severe hypotension. Safety documents also advise against use in individuals with severe hepatic impairment, a recent history of stroke or myocardial infarction, and known hereditary retinal disorders like retinitis pigmentosa. Additionally, specific safety notes address reduced drug clearance in older adults and those with severe renal or hepatic impairment, often necessitating consideration for dose adjustment as described in regulatory labels.

Overdose and Emergency Response

Overdose and when to seek help

An overdose of Erosfil (Sildenafil Citrate) may result in a notable increase in the frequency and severity of expected adverse events. Documented clinical manifestations of overexposure include pronounced Headache, Flushing, Dyspepsia, Nasal Congestion, and musculoskeletal discomfort such as Myalgia and Pain in Limb. Single doses up to 800 mg have been studied, showing a dose-related increase in these occurrences.

The regulatory documentation highlights specific severe outcomes that necessitate immediate medical intervention. These include clinically significant Hypotension and a serious urological event known as Priapism. Priapism is defined as an erection persisting for longer than four hours; regulatory instruction mandates seeking immediate medical assistance to prevent potential permanent tissue damage.

Furthermore, Sudden Loss of Vision in one or both eyes and Sudden Decrease or Loss of Hearing (which may be accompanied by ringing in the ears) are conditions requiring immediate or prompt medical attention, as stated in the official labeling.

Management and Population Notes

  • No specific antidote is known for Sildenafil overdose, meaning clinical management is strictly symptomatic and supportive, including close monitoring of the patient's condition.
  • Due to high plasma protein binding, regulatory sources state that renal dialysis is not expected to accelerate clearance.
  • Increased plasma exposure is documented in patients with severe hepatic or renal impairment. Specific regulatory findings have noted an increase in mortality with increasing doses in certain pediatric patients.

Therapeutic Uses of Erosfil

What Erosfil Treats: Main Uses and Benefits

Erosfil is used to manage symptoms associated with specific conditions, which may support a patient’s overall quality of life. The medication is primarily indicated for two therapeutic domains: erectile dysfunction (ED) and pulmonary arterial hypertension (PAH).

For ED, clinical scenarios involve its use to offer support for the ability to obtain an erection when sexually stimulated. For PAH, it is used to support exercise ability and may assist in delaying clinical worsening. The main benefit observed by patients is the relief of physical symptoms that may affect daily function.

As a patient might summarize the experience, “...it helped me address a challenging physical issue.”

Quick Fact: Relief for Erectile Dysfunction and Pulmonary Arterial Hypertension

Eligibility and Restrictions for Use

Who can and cannot use Erosfil?

Eligibility for Erosfil (Sildenafil Citrate) is determined by specific population groups, concurrent treatments, and pre-existing health conditions, as mandated by official regulatory bodies such as the FDA and EMA.

Approved Populations: The medicine is indicated for use in adult men for the Erectile Dysfunction (ED) indication. For the Pulmonary Arterial Hypertension (PAH) indication, it is approved for adult patients and pediatric patients aged 1 to 17 years. Use in children under 1 year is generally not established.

Absolute Contraindications (Must Not Use): Erosfil is formally prohibited for patients who are taking any form of organic nitrates or nitric oxide donors (e.g., nitroglycerin), or certain soluble guanylate cyclase (sGC) stimulators. These combinations can cause a severe, life-threatening drop in blood pressure.

Contraindications also apply to individuals with severe hepatic impairment (Child-Pugh Class C), a recent history of stroke or myocardial infarction, severe resting hypotension (BP <90/50 mmHg), or known hypersensitivity to sildenafil.

Use Requiring Caution: Special consideration is required for patients with severe renal or hepatic impairment, for whom a lower initial dose may be necessary for the ED indication. Caution is also advised in geriatric patients, those with anatomical deformation of the penis, or conditions that predispose to priapism, such as sickle cell anemia.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Erosfil (Sildenafil Citrate) possesses a defined interaction profile based on official regulatory labeling, primarily concerning its pharmacodynamic and metabolic properties.

Contraindicated Combinations

Co-administration with organic nitrates and nitrite donors is formally contraindicated due to the risk of severe, life-threatening hypotension from additive vasodilatory effects. The simultaneous use of Sildenafil with a soluble guanylate cyclase (sGC) stimulator such as Riociguat is also strictly prohibited for the same reason. Use with other PDE5 inhibitors is not recommended.

Pharmacokinetic Interactions

Sildenafil clearance is affected by drugs that interfere with the CYP3A4 metabolic pathway. Potent CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole) reduce Sildenafil clearance, significantly increasing plasma exposure and requiring administration adjustments. Conversely, CYP3A4 inducers (e.g., Rifampicin) may decrease exposure.

Pharmacodynamic and Food Interactions

Co-administration with alpha-blockers may lead to an additive hypotensive effect, with the highest risk of symptomatic hypotension occurring within four hours of Sildenafil administration. In terms of substance interactions, consumption of a high-fat meal may delay the absorption rate of Sildenafil, and grapefruit juice may increase its plasma concentration.

Mechanism of Action

Erosfil is a small molecule antagonist that selectively binds to the Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL). This binding competitively inhibits the interaction of RANKL with its receptor, Receptor Activator of Nuclear factor Kappa-B (RANK), on the surface of pre-osteoclast cells. The inhibition of the RANK/RANKL axis leads to decreased RANKL-mediated osteoclastogenesis and reduced bone resorption.

Erosfil concurrently influences the canonical Wnt signaling pathway by preventing the degradation of beta-catenin. This action promotes the stabilization and subsequent nuclear translocation of beta-catenin, which acts as a transcriptional co-activator. This results in sustained upregulation of osteoblast proliferation and differentiation gene expression, consequently altering the ratio of bone formation to resorption activity.

Dosage and Administration Information

Erosfil (sildenafil citrate) is administered under two distinct protocols, with the specific regimen determined by the condition being addressed. The medication is supplied in both oral forms, including tablets and a reconstituted suspension, as well as an intravenous (IV) injection solution for specialized use.


Regimens based on Official Indication

For the condition requiring as-needed use, the maximum frequency is limited to once per day. The typical oral starting dose is 50 mg, which may be adjusted within a range of 25 mg to 100 mg. For the condition requiring continuous, scheduled use, the standard oral dose is 20 mg taken three times a day (TID), with the IV dose set at 10 mg TID when oral intake is restricted. Both oral and IV scheduled doses are administered approximately four to six hours apart.


Administration Contexts

The oral forms of sildenafil may be taken with or without food. However, consumption with a high-fat meal may result in a delay in the rate of drug absorption. Dosage adjustments are specified for certain patient groups: a 25 mg starting dose may be considered for older adults, as well as patients with severe hepatic or renal impairment. If a scheduled dose for the continuous regimen is missed, the protocol generally involves skipping that dose and resuming the normal schedule if the time for the next dose is rapidly approaching.

Recent Clinical Evidence

Research evidence / Overview of studies for Erosfil

Research Evidence for Managing Erectile Dysfunction (ED)

The evidence base for Erosfil explores its evaluation in adult men who have erectile dysfunction is primarily built upon numerous short-term, randomized, placebo-controlled trials (RCTs). These studies randomly assigned participants to receive either the medicine or an inactive placebo for periods of four to twelve weeks. Research examined patient-reported outcomes describing perceived discomfort and functional scores, which are used in research exploring how symptoms change over time.

Research highlights the differences in measurements recorded during the study period when comparing the experiences of the groups. Research describes the patterns observed in the measured outcomes across different ED etiologies studied, including organic and psychogenic causes. However, follow-up durations were limited in the primary, controlled trials, meaning there is limited information for long-term outcomes regarding sustained use extending beyond one to two years.


Research Evidence for Treating Pulmonary Arterial Hypertension (PAH)

Erosfil was also evaluated in controlled clinical research in the PAH population, a condition marked by functional limitations. The core evidence for this indication comes from several large, randomized, placebo-controlled trials, which are often referenced in regulatory documents. Research examined outcomes related to systemic or functional imbalance, including the monitoring of the patient's capacity for physical activity, often measured by the 6-Minute Walk Distance (6MWD).

Studies also monitored the time until a patient experienced a serious event related to their condition, known as time to clinical worsening. Studies monitored patients' functional class (a doctor's classification of disease severity) for potential changes. For pediatric patients, a specific pattern was observed in some studies when evaluating high doses, which was associated with patterns of clinical outcomes that led to particular regulatory caution regarding long-term, high-dose use in that group.


Gaps and Areas of Uncertainty in the Research

While trials provide information on short-term evaluation, long-term effects are not fully established regarding sustained functional impact, particularly for chronic conditions like PAH. Regulators and peer reviewers note that the evidence quality varies across studies, and they cite limitations including limited follow-up duration in primary trials and modest sample sizes in some niche subgroup analyses. Furthermore, comparative evidence is lacking for direct, head-to-head comparisons of Erosfil against all other therapeutic options.

Key Studies & References

  1. The Sildenafil Trial for Pulmonary Hypertension (SUPER-1): Efficacy and Safety of Sildenafil in Adults with Pulmonary Arterial Hypertension

Frequently Asked Questions (FAQ)

Common questions about Erosfil (FAQ)

Q: How long can the effects of Erosfil last?

A: According to the official product information for the as-needed indication, the effects of Erosfil can typically last for up to 4 hours after administration. The duration of the effect may vary among individuals.

Q: Is it normal to feel dizzy after taking Erosfil?

A: Official regulatory documents list dizziness as a common side effect. This means it is a known event for some people taking the medication. Patients should be aware that dizziness may impact their ability to perform tasks requiring alertness.

Q: What's the difference between Erosfil and a supplement for the same purpose?

A: Erosfil is a prescription pharmaceutical containing a classified active ingredient, Sildenafil Citrate, which is a selective PDE5 inhibitor. Supplements are not regulated under the same pharmaceutical testing standards as prescription medicines to confirm their safety and efficacy profile required for marketing authorization.

Q: What happens if I miss a dose of Erosfil?

A: For the continuous, scheduled use (such as for the treatment of pulmonary hypertension), official guidance recommends that if a dose is missed, the patient should generally skip that dose and resume the normal schedule. This guidance applies when the time for the next scheduled dose is near.

Q: Why do some people say Erosfil doesn't work for them?

A: Studies indicate that the absorption of the medicine can be delayed by taking it with a high-fat meal, which may impact how quickly it starts working. Additionally, studies conducted during development indicate that individual patient response to the drug can vary.

Q: What are the typical benefits people experience after taking Erosfil?

A: For the approved conditions, the central function of the drug is to promote vascular relaxation, facilitating increased local blood flow. Benefits observed in clinical research include improvements in functional scores or increased capacity for physical activity, such such as the 6-Minute Walk Distance (6MWD), depending on the indication.

Q: What should I do if the side effects of Erosfil bother me?

A: Official labeling highlights certain serious, though rare, adverse reactions, such as a prolonged erection (Priapism) lasting over four hours, or a sudden decrease or loss of vision or hearing. The labeling specifies that these serious events are critical safety components associated with the drug’s use.

Q: Does alcohol reduce the effectiveness of Erosfil?

A: Regulatory information advises caution regarding alcohol consumption. Alcohol can amplify the drug's vasodilatory effects, which may increase the risk of low blood pressure and associated side effects like headache and dizziness.

Q: Is Erosfil addictive?

A: Erosfil is generally not scheduled as a controlled substance by major regulatory bodies in most jurisdictions. This classification indicates that the medicine does not have a recognized potential for dependence or addiction.

Q: Can Erosfil be crushed or chewed?

A: Erosfil is primarily supplied as oral tablets that are meant to be swallowed whole. The official prescribing information does not provide instructions or a recommendation for crushing or chewing the tablets.

Q: Can Erosfil be taken along with antacids?

A: Studies on the co-administration of the active ingredient with common antacids (e.g., magnesium hydroxide/aluminum hydroxide) showed no clinically significant effect on the drug’s absorption or concentration in the body.

Q: How does Erosfil compare to [another similar drug] in terms of side effects?

A: Official regulatory documents detail the specific adverse reaction profile of Erosfil. However, these documents do not typically contain direct, head-to-head comparative data detailing side effects against all other therapeutic options in the same class.

Q: Is the research evidence for Erosfil strong?

A: The drug’s approval is based on evidence, including multiple randomized, placebo-controlled trials (RCTs) demonstrating its efficacy. Regulators note limitations, such as limited long-term follow-up in some primary trials, when evaluating the evidence.

Q: Can people with kidney problems use Erosfil?

A: Special consideration is necessary for patients with severe renal impairment because the body's clearance of the medicine may be reduced. Official regulatory information indicates that use in this group may require consideration of a lower initial dose.

Q: What are the signs of an allergic reaction to Erosfil?

A: Official labeling lists hypersensitivity reactions as a possible side effect. The labeling notes hypersensitivity to the active ingredient is an absolute contraindication and advises that any acute, severe reaction is a safety consideration.

Q: Is Erosfil available over the counter?

A: Erosfil is classified by major regulatory bodies as a prescription-only medicine in most regions. It requires a prescription due to its defined interaction and safety profile.

Q: Why is a prescription needed for Erosfil?

A: A prescription is required because the medicine carries a defined risk profile, including absolute contraindications—such as its use with nitrates—that must be screened for by a healthcare professional. The medication also requires that a healthcare professional determine appropriate use based on individual health conditions.

Q: Is there a generic version of Erosfil available?

A: Yes, following patent expiry, the active ingredient in Erosfil, Sildenafil Citrate, is available from various manufacturers as a generic drug.

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

A: The regulatory label primarily focuses on known, major interactions (e.g., with nitrates, CYP3A4 inhibitors, and alpha-blockers). There are generally no specific warnings detailed in the official product information regarding interactions with common over-the-counter pain relievers.

Q: Are there any known interactions between Erosfil and common herbal supplements?

A: Official labeling details interactions with substances that affect the CYP3A4 metabolic pathway in the liver. Some herbal supplements, such as St. John's Wort, are known to affect this pathway and could potentially alter the level of Erosfil in the body.

Q: Does taking Erosfil affect fertility?

A: Regulatory documents and reviews generally do not indicate clear evidence that Erosfil reduces fertility in men or women.

Q: Is it safe to drive after taking Erosfil?

A: The medicine can cause side effects like dizziness and changes in vision (e.g., blurred vision or color distortion). Regulatory labels advise that patients should be aware of how the medicine affects them before they drive or operate heavy machinery.

Q: What is the typical time frame for seeing results with Erosfil?

A: For the as-needed indication, the medicine typically begins to work quickly, with effects starting to occur within 30 to 60 minutes after taking the tablet.

Q: Does Erosfil have any psychological side effects?

A: Official adverse reaction lists include effects related to the central nervous system, such as headache and dizziness, both of which are common. However, regulatory documents do not generally detail or report common emotional or personality changes.

How should Erosfil be stored and disposed of?

How to Store and Dispose of Erosfil (Sildenafil Citrate)

The storage and disposal of Erosfil must follow conditions strictly defined by regulatory labeling to maintain the product's integrity and ensure safety.

Storage Requirements

Erosfil tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). The product must be protected from light and moisture and kept in its original container with the cap tightly closed. It is mandatory to store the medicine in a secure location that is out of the sight and reach of children and pets.

Disposal Instructions

Unused or expired Erosfil should be disposed of using a drug take-back program. If a take-back option is unavailable, the medication is not to be flushed down the toilet. Instead, it must be mixed with an unappealing substance, sealed in a bag, and then discarded in the household trash, adhering to environmental restrictions against disposal via wastewater.

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

Available in countries:

Equivalent of Erosfil found in:

A-Z Index: