Silden

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Silden

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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 Silden

Quick Facts

Property Description
Active ingredient Sildenafil (as the citrate salt)
Form Film-coated tablets, Oral suspension
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
Common use Systemic vasodilator (to enhance localized blood flow)
Origin Synthetic (chemically synthesized)

What Type of Medicine is Silden (Sildenafil)?

Silden is a pharmaceutical preparation containing the active substance Sildenafil, a synthetic compound classified as a highly selective Phosphodiesterase type 5 (PDE5) inhibitor. This classification is applied because the drug is specifically engineered to block the action of the PDE5 enzyme within the body's smooth muscle tissues. The molecule is the product of synthetic processes, establishing it as a manufactured chemical entity rather than a natural extract.

The specificity of the PDE5 inhibitor class is its key defining characteristic. This focused mechanism distinguishes Sildenafil from older, less-selective cardiovascular agents. As a single-ingredient oral agent, Silden is formulated for systemic absorption, providing a targeted effect to modulate vascular function.

Composition, Forms, and General Therapeutic Purpose

The Silden preparation utilizes Sildenafil citrate—the stable salt form of the molecule—combined with standard pharmaceutical excipients, and is predominantly available as film-coated tablets. This controlled formulation facilitates accurate, systemic delivery following oral administration.

The pharmacological activity of Sildenafil serves the general purpose of facilitating hemodynamic changes. By inhibiting the PDE5 enzyme, the drug prevents the rapid breakdown of cyclic Guanosine Monophosphate (cGMP). This preservation of cGMP induces the relaxation of smooth muscles in the arterial walls, resulting in a temporary increase in localized blood flow. This action allows Silden to augment the body's natural signaling pathway for vascular dilation, which is the basis for its therapeutic utility.

Regulatory References

  1. Sildenafil - StatPearls - NCBI Bookshelf

What side effects are possible with Silden?

Possible Side Effects and Safety Information

The official regulatory safety profile for Silden (sildenafil) outlines possible adverse reactions and specific limitations, categorized by frequency and the body system affected. This classification is the standard method used by government health authorities like the FDA and EMA to communicate risk.


Adverse Reaction Scope

Category Details (Official Regulatory Documents)
Frequency Classification Very Common (occurs in ge 1 in 10 users): Headache and flushing. Common (occurs in ge 1 in 100 users): Dizziness, dyspepsia (indigestion), nasal congestion, and transient visual disturbances (e.g., blurred vision or a blue/green color tinge to vision).
System-Organ Classes Adverse reactions are primarily documented across the Nervous System (headache, dizziness), Vascular (flushing, hypotension), Gastrointestinal (dyspepsia, nausea), and Eye Disorders (visual changes).
Serious Adverse Reactions Regulatory documentation lists rare but serious events, including Priapism (an erection lasting over four hours), Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION) (sudden loss of vision), and reports of Sudden decrease or loss of hearing. Severe post-marketing Cardiovascular Events (e.g., myocardial infarction, stroke) have also been reported.

Safety Restrictions and Considerations

Silden is subject to absolute regulatory constraints. It is contraindicated for use with nitrate medications (e.g., nitroglycerin) or with guanylate cyclase stimulators due to the substantial risk of severe, sudden hypotension. Official labels note that patients with severe hepatic impairment or severe renal impairment have reduced drug clearance, which requires specific initial dose consideration. Additionally, the incidence of effects like headache and dyspepsia is noted to be dose-dependent.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation defines the Silden (sildenafil) overdose profile by focusing on the exaggeration of expected effects and severe time-critical complications. Overexposure, documented in studies at single doses up to 800 mg, primarily results in an increased incidence and severity of adverse reactions typically experienced at lower, therapeutic doses, such as headache, flushing, and dyspepsia.


Required Emergency Actions

Specific severe manifestations require immediate medical attention as mandated by regulatory authorities:

  • Erection lasting longer than 4 hours (Priapism): Patients must seek immediate medical assistance. This condition can lead to penile tissue damage and permanent loss of potency if untreated.
  • Sudden Sensory Loss: Patients must seek immediate medical attention if they experience sudden loss of vision in one or both eyes or a sudden decrease or loss of hearing.

Management Constraints

Regulatory information states that no specific antidote is known for Sildenafil overdose. Management is therefore limited to standard supportive and symptomatic measures adopted as required. Furthermore, the drug’s high plasma protein binding means renal dialysis is not expected to accelerate clearance of the active substance.

Therapeutic Uses of Silden

Silden (sildenafil) is a medication generally applied across two main therapeutic domains, where it provides support to manage symptoms that create noticeable physiological strain. It is commonly used to help with specific conditions characterized by periods of heightened symptoms. The primary therapeutic uses are addressing symptom clusters related to erectile dysfunction (ED) in males and managing conditions involving episodic or fluctuating manifestations like Pulmonary Arterial Hypertension (PAH).

For individuals experiencing ED, Silden helps with the symptoms related to difficulty achieving or sustaining an erection. This provides support that helps ease the overall symptom burden. For patients with PAH, its use is relevant for managing symptoms that interfere with daily functioning, such as shortness of breath and reduced exercise capacity. In these clinical settings, Silden assists with maintaining functional stability when symptoms become more noticeable. “This medicine is relevant for easing symptoms that create noticeable functional strain.” It supports patients during episodes of heightened discomfort.


Quick Fact: Relief for Symptoms that Interfere with Daily Functioning

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Silden?

Eligibility for Silden is strictly defined by regulatory documents, primarily based on the patient's existing health conditions and concurrent medications.

Contraindicated Populations

Silden must not be used by patients taking any form of organic nitrates or nitric oxide donors (or sGC stimulators), due to the risk of severe hypotension. Use is also formally contraindicated in populations with severe cardiovascular instability, such as a recent stroke or myocardial infarction, or with conditions including severe hepatic impairment, severe hypotension (BP <90/50 mmHg), or a history of specific ophthalmic disorders like NAION.

Age and Conditional Use

Silden is formally indicated for adults 18 years and older for its approved uses. It is not indicated for women for the treatment of erectile dysfunction. For the Pulmonary Arterial Hypertension indication, chronic use of higher doses in pediatric patients is not recommended by some regulators due to safety concerns.

Conditional Use is required for patients with anatomical penile deformation or conditions predisposing them to priapism (e.g., sickle cell disease). Patients with mild to moderate hepatic impairment or severe renal impairment are eligible, but the official labeling notes these groups require special consideration.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Silden's official regulatory profile identifies drug combinations that are either strictly prohibited or require significant management due to altered drug exposure or enhanced pharmacologic effects.

Contraindicated Combinations

Co-administration with all Organic Nitrates (including nitric oxide donors) and the soluble Guanylate Cyclase Stimulator Riociguat is contraindicated. This restriction is due to the documented potentiation of hypotensive effects, which carries a risk of severe, uncontrolled blood pressure lowering.

Pharmacokinetic Interactions (Exposure)

Silden is primarily cleared from the body via the CYP3A4 metabolic pathway. Therefore, co-administration with potent CYP3A4 inhibitors, such as the medicines Ritonavir or Ketoconazole, is documented to reduce Sildenafil clearance and substantially increase plasma exposure. This includes a mandatory timing and dose restriction requiring that the Silden dose must not exceed 25 mg within a 48-hour period when used with Ritonavir.

Pharmacodynamic and Food Interactions

The combination of Silden with alpha-blockers may result in additive blood pressure lowering effects, which is a pharmacodynamic interaction that can lead to symptomatic hypotension. Furthermore, a high-fat meal is officially noted to affect absorption kinetics by reducing the rate and extent of Silden absorption.

Population-Specific Notes

In specific populations, Sildenafil clearance is reduced, leading to increased systemic exposure. This is officially documented for patients with severe renal impairment and severe hepatic impairment.

Mechanism of Action

Selective Inhibition of the PDE5 Enzyme

Silden's action is fundamentally the inhibition of cGMP hydrolysis. It is a selective inhibitor of the Phosphodiesterase type 5 (PDE5) enzyme, which is responsible for the rapid breakdown of the secondary messenger cGMP. By blocking this enzyme, the drug allows cGMP levels to rise and persist within targeted smooth muscle cells.


Potentiation of the NO-cGMP Pathway

The mechanism is conditional, meaning it acts purely as a potentiator of the body’s natural signaling. Silden potentiates the effects of Nitric Oxide (NO), which must first be released physiologically to initiate cGMP synthesis. This sustained cGMP level triggers a molecular cascade that causes the relaxation of arterial smooth muscle (vasorelaxation) and a subsequent increase in regional blood flow in specific vascular beds.


Mechanism Limitations

The drug's mechanism is physiologically limited as it requires upstream NO release to be effective; it cannot generate the signal independently. Additionally, while selective for PDE5, the drug can exhibit cross-inhibition of other PDE isoforms (like PDE6 and PDE11) at higher concentrations, which shapes the observed physiological effects.

Dosage and Administration Information

How Silden Is Used

The usage of Silden (Sildenafil) is dictated by its specific therapeutic application, involving distinct administration routes, dose ranges, and frequency schedules as established in pharmaceutical labeling. The medicine is administered through the oral route (film-coated tablets or suspension) and the intravenous (IV) route (injection).


Administration Patterns and Dosing

Indication Frequency/Schedule Standard Adult Dosing Contextual Instructions
Erectile Dysfunction (ED) As-needed, maximum of once per day Starting dose of 50 mg, adjustable within a 25 mg to 100 mg range Taken approximately one hour before use; may be taken with or without food
Pulmonary Arterial Hypertension (PAH) Fixed-schedule of three times a day (TID), 4 to 6 hours apart Standard oral dose is 20 mg; dose may be titrated up to 80 mg TID Used as part of a long-term plan; oral suspension must be reconstituted and shaken

Population-Specific Use

Official instructions specify that an initial dose of 25 mg should be considered for the ED indication in older adults (65 years and older) and for individuals with severe renal or hepatic impairment. For the PAH indication, the intravenous 10 mg dose is typically reserved for temporary use in patients unable to take the oral forms.

The administration of Silden for ED is intermittent, whereas its use for PAH is chronic for sustained disease management. The maximum daily frequency of once for ED must not be exceeded.

Recent Clinical Evidence

Research evidence / Overview of studies for Silden


Evidence for use in Erectile Dysfunction (ED)

The evidence base for Silden's application in Erectile Dysfunction (ED) includes short-term, randomized controlled trials (RCTs). These studies were applied in research contexts involving fluctuating or unstable symptoms of ED in adult males. The main goal was to measure patient-reported outcomes describing perceived discomfort and changes in measures of sexual activity. Studies monitored how individuals receiving Silden compared to those receiving placebo; findings describe patterns observed in the studies where Silden groups showed higher mean scores on assessments related to erectile function.

However, the existing research has some important limitations. The primary efficacy trials were generally short-term, meaning the results apply only to the immediate periods studied. Follow-up durations were limited in many of the core randomized studies. Therefore, long-term effects are not fully established regarding the sustained persistence of the reported changes over many years.


Evidence for use in Pulmonary Arterial Hypertension (PAH)

The evidence for Silden in Pulmonary Arterial Hypertension (PAH), a condition marked by functional limitations, includes intermediate-term RCTs. Trials primarily monitored outcomes reflecting daily functioning or activity level, such as the 6-minute walk distance (6MWD), and changes in the WHO Functional Class. Studies monitored changes in the 6MWD; findings describe patterns observed in the studies where Silden groups showed a higher mean change compared to those receiving placebo over the assessment period. Research indicates that a greater proportion of adult patients in the Silden groups showed an improved WHO Functional Class categorization compared to placebo.


Research Gaps and Remaining Uncertainty

The primary PAH trials were intermediate-term, providing limited insight into the long-term clinical measure of overall survival. Additionally, comparative evidence is lacking from trials directly setting Silden against other treatments for either ED or PAH. For pediatric patients with PAH, long-term outcomes from one study introduced uncertainty and specific regulatory concern regarding chronic high-dose use.

Frequently Asked Questions (FAQ)

Common questions about Silden (FAQ)

Q: How quickly does Silden start working after taking it?

According to official product information, Silden usually begins to work within 30 minutes after it is taken. For the as-needed indication, it is typically administered from 30 minutes to 4 hours before use.

Q: How long can the effects of Silden last?

Studies and official information indicate that the effects of Silden generally last for up to 4 hours. The concentration of the drug is highest in the body during the first two hours after administration.

Q: How is Silden eliminated from the body?

Silden is cleared from the body primarily after being metabolized by the liver. The drug and its main active form are then eliminated mostly in the feces (about 80% of the dose) and to a lesser extent through the urine.

Q: What is the half-life of Silden?

The terminal elimination half-life of Silden, which describes how long it takes for half of the drug to be removed from the body, is approximately 3 to 4 hours. This information is found in the pharmacokinetic data section of official documents.

Q: What happens if I take Silden too close to another dose?

Official information states that for the as-needed indication, the maximum recommended dosing frequency is once per day. Taking the medicine more often than recommended increases the chance of experiencing common side effects like headache, dizziness, or temporary vision changes.

Q: Is Silden available over the counter, or does it require a prescription?

Silden is generally designated as a medicine available by prescription only in most countries. This status reflects the need for the medicine to be managed by a healthcare provider due to its mechanism and required safety oversight.

Q: What is the difference between Silden and similar-sounding medications?

Silden belongs to the pharmacological class known as Phosphodiesterase type 5 (PDE5) inhibitors. This classification means its main action is the selective blocking of the PDE5 enzyme, which is the mechanism it shares with other medicines in this class.

Q: Does Silden lose effectiveness over time?

Clinical trial data that followed patients over periods of nearly a year (36 to 52 weeks) reported that the effectiveness of Silden was maintained throughout the study duration. Official reports do not indicate a loss of efficacy over the long term.

Q: Can Silden interact with medications for prostate issues?

Yes. Official documents note that Silden can interact with alpha-blockers, a class of medicine sometimes used to treat prostate enlargement. This combination may result in an additive lowering of blood pressure, which may lead to symptomatic hypotension (low blood pressure symptoms).

Q: Are there specific food items to avoid when taking Silden?

Yes, official product information notes that regular consumption of grapefruit or grapefruit juice should be avoided. Grapefruit can increase the amount of Silden in the body, which may increase the chance of side effects and delay the time it takes for the medicine to work.

Q: What is the recommended storage temperature for Silden?

Silden tablets must be stored at a temperature range officially defined as Controlled Room Temperature. This range is specified as 20 C to 25 C (68 F to 77 F) and must be protected from moisture.

Q: Can older adults use Silden?

Silden is indicated for use by adults 18 years and older. For the erectile dysfunction indication, official labeling references a lower starting dose consideration for older adults (ge 65 years) due to the reduced rate at which the drug is cleared from the body.

Q: Can people with kidney problems use Silden?

Patients with severe renal impairment (a serious kidney condition) are noted to have reduced Silden clearance. Regulatory documents reference that a lower starting dose should be considered for this patient group.

Q: Can people with liver issues use Silden?

Patients with hepatic impairment (such as cirrhosis of the liver) are known to have reduced Silden clearance. Official documents reference that a lower starting dose should be considered for this patient group to manage exposure.

Q: What are the general expectations about how Silden works?

Silden works by potentiating the body’s natural signaling pathway. The drug enhances a signal that causes the relaxation of blood vessel smooth muscle and increases blood flow. It must rely on a natural, upstream signal to be effective; it cannot start the process on its own.

Q: Why do official documents warn about using Silden with alpha-blockers?

The official warning is in place because co-administration with an alpha-blocker may lead to symptomatic hypotension. This means the combination can cause an additive drop in blood pressure, potentially causing symptoms like dizziness or fainting.

Q: Is Silden the same as other medicines for the same condition?

Silden shares the pharmacological classification of a Phosphodiesterase type 5 (PDE5) inhibitor with other medicines used for the same conditions. This means they share the same fundamental mechanism of action, though their specific chemical structure may be different.

Q: Are there any known interactions between Silden and alcohol?

Silden itself can lower blood pressure, and official information indicates that combining it with alcohol may further increase this effect. This combination could increase the chance of experiencing side effects such as headache, dizziness, and flushing.

Q: Has Silden been studied in women?

Yes, Silden has been studied in women for conditions such as female sexual dysfunction. However, these clinical trials did not show a clear benefit, and the drug is not indicated for women for the treatment of erectile dysfunction.

Q: Is it true that Silden was originally developed for a different use?

Yes. Silden was originally identified as a PDE5 inhibitor during a research effort to develop medicines for angina pectoris, which is a type of chest pain caused by reduced blood flow to the heart.

Q: Are there warnings about driving or operating machinery while on Silden?

Official documents reference that the use of tools or machinery may be impacted if side effects such as dizziness or temporary visual disturbances occur. This is noted as a caution for patients.

Q: What is the safety profile of Silden in people with diabetes?

Clinical trials for Silden have included patients who have diabetes mellitus. Findings from early studies noted that patients with diabetes showed a lower overall response rate compared to patients whose condition had primarily organic causes.

Q: Why is Silden sometimes given a different name in other countries?

Silden is the common name for the active ingredient, Sildenafil. The medicine is often marketed under different trade names (brand names) in various countries and for different approved medical uses, depending on the specific marketing license.

Q: What if Silden doesn't seem to work for me?

Official information states that the dose may be adjusted based on effectiveness and toleration. The maximum recommended dose for as-needed use is defined in the product label.

Q: Does taking Silden multiple times a day offer better results?

For the as-needed use, the maximum recommended dosing frequency is once per day. Taking more than the maximum dose is not officially recommended and is associated with an increased chance of experiencing adverse effects.

Q: How long has Silden been approved for use?

Silden was first approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction in March 1998. It has been in use for over two decades.

Q: What should I do if I miss a scheduled time for Silden?

For the fixed-schedule treatment (PAH), official advice describes that a forgotten dose should be taken as soon as it is remembered, unless it is nearly time for the next scheduled dose, in which case the missed dose is omitted.

How should Silden be stored and disposed of?

How to Store and Dispose of Sildenafil

Sildenafil tablets must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with protection from moisture. The medication must be kept in its original container to maintain its stability.

Product-Specific Handling

  • Oral Suspension: Once reconstituted, the liquid suspension has a strict 60-day shelf-life and must be discarded afterward. The liquid formulation must not be frozen.
  • Child Safety: All forms of sildenafil must be kept out of the sight and reach of children to prevent accidental exposure.

Disposal Requirements

Unused or expired sildenafil must be handled according to environmental mandates. The product must not be flushed down the toilet or sink, as it is not on the recommended flush list. Disposal should utilize a drug take-back program or follow official guidelines for mixing with an undesirable substance before discarding in household trash.

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

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