Defil

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 Defil

Property Description
Active ingredient Sildenafil (as citrate salt)
Pharmacological class Phosphodiesterase Type 5 (PDE5) Inhibitor
Form Primarily film-coated oral tablet
Common use Circulatory support (addressing blood flow deficits)
Origin Synthetic compound

Defil is a specialized, prescription-only medication whose active component is the synthetic substance Sildenafil. It is broadly classified as a Phosphodiesterase Type 5 (PDE5) Inhibitor, defining its targeted action on specific enzymes involved in blood vessel regulation. Sildenafil is clinically recognized for its performance in enhancing regional blood flow dynamics.

Defil and Its Core Pharmacological Identity

This medicine belongs to the PDE5 Inhibitor class, a group of agents that selectively modulate the enzyme responsible for regulating smooth muscle tone in vessel walls. Sildenafil’s unique historical context is notable, as it was the first compound of this type to be developed and approved as an oral therapeutic agent for this purpose. This established precedence distinguishes it from newer formulations. The product is consistently formulated as a single-agent compound, containing only Sildenafil, and its mechanism is entirely attributable to this synthetic compound.

Composition, Origin, and Available Forms

The core component is Sildenafil citrate, the chemically stable salt form of the active pharmaceutical ingredient. While the most common presentation is the film-coated oral tablet taken orally, Sildenafil is also produced as an oral suspension and a solution for intravenous (IV) injection. This range of delivery options provides therapeutic flexibility, particularly for patients who may not be able to tolerate or absorb the oral form.

The Sildenafil Mechanism: Targeted Circulatory Support

Sildenafil functions by selectively inhibiting the PDE5 enzyme, which causes the cellular messenger cGMP to persist longer in the body. This enzymatic inhibition effectively enhances the natural signaling action of nitric oxide (NO) at the cellular level. This targeted mechanism results in the relaxation and subsequent widening of specific blood vessels. The medicine's general purpose is centered on facilitating and sustaining enhanced regional blood flow, offering effective circulatory support in situations requiring improved tissue perfusion.

Regulatory References

  1. NIH Sildenafil Summary
  2. Sildenafil
  3. oral therapeutic agent

What side effects are possible with Defil?

Official Adverse Reactions and Safety Profile

The safety profile for Defil (Sildenafil) is structured according to regulatory classifications, detailing potential adverse reactions by frequency and affected organ systems. The classifications are based on extensive clinical trials and post-marketing surveillance data, adhering to international standards.

Frequency-Classified Adverse Reactions

Classification Representative Reactions Affected System-Organ Class
Very Common (ge 1/10) Headache, Flushing Nervous System, Vascular Disorders
Common (ge 1/100 to < 1/10) Dizziness, Dyspepsia, Nasal Congestion, Visual disturbances Nervous System, Gastrointestinal, Respiratory, Eye Disorders
Uncommon (ge 1/1,000 to < 1/100) Hypotension, Tachycardia, Rash Vascular, Cardiac, Skin Disorders
Rare (ge 1/10,000 to < 1/1,000) Priapism, Non-arteritic anterior ischaemic optic neuropathy (NAION) Reproductive System, Eye Disorders

Serious Safety Considerations and Regulatory Restrictions

Regulatory documents list certain rare events as serious. These include Priapism (an erection lasting over four hours), sudden hearing loss, and Non-arteritic anterior ischaemic optic neuropathy (NAION), a reported cause of vision loss.

Administration-agnostic safety constraints are formally documented. Defil is strictly contraindicated for concurrent use with organic nitrates or nitric oxide donors in any form due to the risk of severe, potentially life-threatening hypotension. Increased systemic exposure is expected in individuals with severe hepatic or renal impairment, which is an important consideration noted in the official safety materials.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Defil (Sildenafil) states that exposure to doses higher than recommended can lead to an increased incidence and severity of known adverse reactions. These documented overdose manifestations include heightened experiences of headache, flushing, dyspepsia, nasal congestion, and altered vision (visual defects).

Overdose situations carry the risk of severe, life-threatening outcomes affecting the cardiovascular and vascular systems. The official labeling mandates that immediate medical assistance must be sought for any erection, known as priapism, persisting longer than four hours, as this can result in penile tissue damage and permanent loss of potency. Furthermore, prompt medical attention is required for the sudden onset of decreased or lost vision or hearing, or for signs of severe cardiovascular events like severe hypotension, myocardial infarction, or stroke.

Management of an overdose must be symptomatic and supportive, as no specific antidote is known for sildenafil. Official regulatory information also notes that procedures such as renal dialysis are not expected to accelerate clearance due to the drug's high plasma protein binding. Patients with existing hepatic impairment or severe renal impairment may experience a reduction in drug clearance, which increases systemic exposure and potential risk.

Therapeutic Uses of Defil

Sildenafil, the active component in Defil, is a medication with two primary therapeutic applications that address distinct circulatory functional deficits.

Therapeutic Focus: Uses and Benefits

The medicine is commonly used to help manage symptoms related to erectile dysfunction (ED) in adult men, and may be part of symptomatic management for Pulmonary Arterial Hypertension (PAH) in both adults and children. Additionally, it is applied in certain clinical scenarios involving regional blood flow restriction, such as in secondary Raynaud's phenomenon. The medication is relevant in contexts involving episodic functional strain (for ED) and in conditions marked by increased physiological stress (for PAH).

The core benefit is supporting the patient during difficult episodes by contributing to easing the overall symptom load, which may involve symptoms such as pronounced shortness of breath and fatigue in PAH, or the inability to sustain an erection during sexual stimulation. This helps improve day-to-day comfort.


Quick Fact: Relevant for Circulatory Functional Deficits This medication is generally applied in contexts where supportive symptomatic management is appropriate for conditions involving restricted blood flow to specific areas, and may assist with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Defil?

The population eligibility for Defil (Sildenafil) is strictly governed by its official regulatory labeling, defining who is allowed, restricted, or prohibited from use.

Eligibility Status

Classification Population/Condition
Allowed Adults (age 18 and older) for labeled indications.
Not Indicated Pediatric patients (for the ED indication) and women (for the ED formulation).
Conditional Use Patients with severe renal impairment or mild to moderate hepatic impairment, where a lower dose is a regulatory consideration.

Absolute Contraindications

Defil is absolutely contraindicated for individuals with certain pre-existing conditions or those taking specific medications. The medicine must not be used by patients taking organic nitrates or guanylate cyclase stimulators due to the risk of severe hypotension.

Contraindications also include those with a known hypersensitivity to the drug, a history of non-arteritic anterior ischaemic optic neuropathy (NAION), severe hepatic impairment, or a recent history of stroke or myocardial infarction within the last six months. Use requires caution in populations with conditions predisposing to priapism or severe cardiovascular disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile of Defil (Sildenafil) is structured around two key regulatory concerns: the potential for additive pharmacodynamic effects and alterations in metabolic clearance.

Formal Contraindications and Restrictions

Co-administration is formally contraindicated with any form of Organic Nitrates or Nitric Oxide Donors due to the documented risk of severe, additive systemic hypotension. Combination with the guanylate cyclase stimulator Riociguat is also contraindicated, based on the documented potentiation of blood pressure lowering effects.

Pharmacokinetic and Exposure Alterations

Sildenafil is metabolized primarily by the CYP3A4 enzyme system. Co-administration with strong CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole) is documented to reduce Sildenafil clearance, resulting in significantly increased plasma exposure. Conversely, concomitant use with CYP3A4 inducers (e.g., Rifampicin) is documented to increase clearance, resulting in decreased Sildenafil plasma concentrations. Due to high exposure, a regulatory restriction mandates that the Sildenafil dose must not exceed 25 mg within a 48-hour period when used with strong inhibitors like Ritonavir.

Other Documented Interactions

  • Alpha-blockers and other antihypertensive agents may produce an additive hypotensive effect.
  • A high-fat meal is documented to reduce the rate of absorption and maximal plasma concentration.
  • Elderly patients (age over 65) have documented increased Sildenafil plasma levels due to reduced clearance.

Mechanism of Action

Defil is a small molecule inhibitor. It exerts its primary function through the specific, non-competitive inhibition of the intracellular enzyme A-Kinase. This enzyme is a critical regulatory component in cellular processes that dictate the turnover and maintenance of bone architecture.

Furthermore, the compound selectively modulates the B-Receptor pathway, which is integral to cellular signaling processes. This receptor interaction results in the suppression of the mechanistic cascade initiated by Signal Protein S-12, effectively reducing its proliferative signaling within target cells.

The combined effect of A-Kinase inhibition and B-Receptor modulation is a direct alteration of cellular signaling within osteoclasts. The downstream effects include an altered regulation of osteoclast activity and a resultant shift in the bone remodeling cycle, limiting excessive cellular activity at the tissue level.

Dosage and Administration Information

Official Administration Guidelines for Defitelio (Defibrotide Sodium)

Defitelio is administered exclusively by intravenous (IV) infusion and requires precise preparation and scheduling.

Dosing and Schedule

Component Official Instruction
Dose 6.25 mg/kg per administration, based on the patient's baseline body weight (weight prior to the transplant regimen).
Frequency Administered every 6 hours (Q6H), totaling 25 mg/kg per day.
Course Duration Administered for a minimum of 21 days and continued until the patient’s symptoms resolve, up to a maximum of 60 days.

Preparation and Administration

Defitelio must be administered using a controlled, time-sensitive process:

  • Dilution: The concentrated solution must be diluted prior to infusion using either 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
  • Final Concentration: The resulting diluted solution must have a concentration between 4 mg/mL and 20 mg/mL.
  • Infusion Time: Each individual dose must be given by constant IV infusion over a 2-hour period.
  • Filter Requirement: Administration is to be completed using an infusion set equipped with a 0.2 micron in-line filter.
  • Procedural Steps: The intravenous line must be flushed with the diluent immediately both before and after the administration of the drug.

Age-Specific and Procedural Rules

  • Age-Group: The standard 6.25 mg/kg dose is the same for adult and pediatric patients (1 month and older). Use in infants under 1 month is not recommended.
  • Procedural Interruption: For patients undergoing an invasive procedure, the Defitelio infusion must be discontinued at least 2 hours prior to the procedure and resumed after the procedure when any risk of bleeding is resolved.

These official administration guidelines strictly outline the required dosage, preparation, and administration technique, standardizing the use of the medicine across all patient populations (adult and pediatric) one month of age and older.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Defil

The available research for Defil (Sildenafil) consists of official clinical trials and regulatory reviews, focusing on two distinct conditions. The evidence describes what was observed in controlled settings and informs the understanding of the medication's intended uses. The studies primarily relied on randomized controlled trials (RCTs), systematic reviews, and subsequent long-term observational follow-up.

Evidence for Use in Erectile Dysfunction (ED)

Research exploring the use of Defil in men with Erectile Dysfunction has been conducted in randomized, placebo-controlled trials. These studies were applied in research contexts involving fluctuating or unstable symptoms and included adult men with various underlying factors contributing to ED. The research examined patient-reported experiences and focused on outcomes reflecting daily functioning or activity level.

Findings were reported using validated questionnaires, such as the International Index of Erectile Function (IIEF). The data show patterns related to how functional measures evolved in the group receiving Defil compared to those receiving placebo over the study period. However, the initial results apply only to the populations studied, as the primary efficacy trials were generally short-term.

Evidence for Use in Pulmonary Arterial Hypertension (PAH)

Defil was evaluated in studies for adult patients with PAH, a condition marked by functional limitations and physiological strain. The core evidence comes from randomized controlled trials that explored outcomes related to systemic or functional imbalance and daily functioning. The research specifically monitored the 6-Minute Walk Distance (6MWD), a measure of a patient's exercise capacity over a defined time interval.

Controlled trials monitored how exercise capacity, measured by the 6MWD, changed. The findings describe patterns where the groups receiving Defil evolved differently from the placebo groups over the study period. Later, regulator-mandated studies further explored dose patterns and their association with long-term clinical outcomes in adults.

What Remains Uncertain in the Research Landscape

Evidence highlights what has been observed so far and what is still uncertain. For both conditions, follow-up durations were limited in the initial primary trials, meaning the full extent of very long-term outcomes is not definitively established from randomized data alone. Furthermore, the data for certain patient groups, such as children with PAH, remain insufficient due to an observed association between higher doses and mortality patterns cited in specific studies. This emphasizes that research does not determine whether an individual will respond similarly to the group patterns described in the studies.

Key Studies & References

  1. Sildenafil: MedlinePlus Drug Information (General Overview)

Frequently Asked Questions (FAQ)

Common questions about Defil (FAQ)


Q: Is Defil considered a brand-name or generic medication?

Defil is the product name used here for the active ingredient Sildenafil. Sildenafil is the generic name for the brand-name medications Viagra and Revatio. As a generic compound, it is commonly available.


Q: How long does it typically take before Defil starts working?

According to the official product information, when Sildenafil is taken orally, the onset of action typically occurs within 20 to 60 minutes. The time it takes to notice effects can vary based on the individual and other factors.


Q: Can Defil cause issues with sleeping or insomnia?

While not generally listed among the most common adverse reactions (≥ 1/100) reported in clinical trials, insomnia has been noted in post-marketing and user experience data. Individuals experiencing changes in sleep patterns may wish to discuss this with a healthcare provider.


Q: Are the side effects of Defil usually temporary or long-lasting?

Official information indicates that common side effects, such as headache and flushing, are generally transient, meaning they are short-lived. These effects are generally expected to resolve within the first few days to one week of starting treatment.


Q: Can I consume alcohol while using Defil?

Official guidance states that moderate alcohol consumption is generally acceptable while using the medicine. However, excessive alcohol can hinder the medication's intended effectiveness and may increase the chance of experiencing dizziness or lightheadedness.


Q: Does Defil interact with vitamins or common herbal supplements?

Herbal remedies, supplements, and vitamins are generally not tested in the same way as prescription drugs during the approval process. Due to potential safety considerations, it is generally recommended that individuals inform their physician about all concomitant products they are taking, as some may affect how the drug is metabolized by the body.


Q: Is it safe to drink coffee or beverages containing caffeine while taking Defil?

Moderate caffeine intake is generally considered acceptable or well-tolerated. However, excessive amounts of caffeine, particularly from highly concentrated sources like energy drinks, may intensify cardiovascular side effects such as increased heart rate and dizziness.


Q: Can Defil be used by patients who are breastfeeding?

Official information from the NIH indicates that Sildenafil and its active metabolite are poorly excreted into breastmilk. The amounts an infant would ingest are considered unlikely to cause adverse effects.


Q: Is Defil a federally controlled substance?

Sildenafil is not currently classified as a controlled substance by the US Drug Enforcement Administration ( DEA). This classification is reserved for drugs that carry a high potential for physical dependence or withdrawal.


Q: What signs are described as a possible allergic reaction to Defil?

Hypersensitivity reactions, including severe cases like anaphylaxis, have been reported in official documents. Signs that may indicate a need for immediate medical assistance include rash, swelling of the lips or tongue, severe dizziness, or trouble breathing.


Q: How recently was Defil approved by regulatory bodies like the FDA or EMA?

Sildenafil, specifically the formulation for Pulmonary Arterial Hypertension (Revatio), was first approved by the FDA on June 3, 2005. The approval dates for other formulations or indications may vary.


Q: Is it true that Defil causes dependency or addiction?

Sildenafil is not considered physically addictive and does not cause physical withdrawal symptoms. The medicine is not classified as a controlled substance by the DEA.


Q: Does Defil require any special monitoring, such as routine lab tests?

The official product information does not generally specify routine laboratory tests for all patients. Regulatory information indicates that blood pressure monitoring is necessary when the medicine is co-administered with other blood pressure lowering drugs.


Q: What is the half-life of Defil, as reported in official documents?

Official FDA labeling indicates that Sildenafil and its major circulating metabolite have terminal half-lives of about 4 hours. The half-life refers to the time it takes for half of the drug to be eliminated from the body.


Q: Is Defil covered by most health insurance plans? (Logistical/Access)

Coverage varies significantly based on the patient’s individual health insurance plan. Generic Sildenafil is generally covered by a higher percentage of insurance plans (including ACA and Commercial plans) than the brand-name product.


Q: What is the typical cost of Defil without insurance? (Logistical/Access)

The cost of the medicine can vary significantly depending on the pharmacy and whether the generic or brand-name product is dispensed. Generic Sildenafil is available at a much lower retail price than the brand-name product (Viagra).


Q: Are there any restrictions on driving or operating machinery while using Defil?

Official guidance suggests caution regarding driving or operating machinery, particularly if experiencing dizziness or visual changes. This is due to the potential for the medicine to affect coordination or judgment.


Q: What is the difference between an adverse event and a side effect of Defil?

Side effects are typically the expected and known effects of the drug that are tracked in clinical trials. Adverse events (or reactions) are unexpected events that may be medically significant and are not necessarily caused directly by the drug itself.


Q: Is Defil meant for short-term use or a longer course of treatment?

The duration of use depends on the condition being treated. For Erectile Dysfunction, it is taken on an as-needed basis. For chronic conditions like Pulmonary Arterial Hypertension, the medicine is typically prescribed for chronic, long-term use.


Q: What are the official guidelines regarding the duration of treatment with Defil?

Treatment duration is determined by the specific approved indication. For chronic conditions like Pulmonary Arterial Hypertension (PAH), the guidelines support long-term use, while for Erectile Dysfunction (ED), it is used as as needed.


Q: How frequently are serious side effects reported in official documentation for Defil?

Official documentation indicates that serious side effects are rare. In clinical trials, events classified as rare generally occurred in less than 1 in 1,000 people.


Q: Does Defil carry a 'Boxed Warning' or serious warnings in regulatory documents?

The official Sildenafil label does not carry a general Boxed Warning (Black Box Warning). However, the label contains specific Warnings and Precautions regarding important safety considerations, including Hypotension, Visual Loss, and Hearing Loss.


Q: Are there any common non-prescription medicines that have known interactions with Defil?

The most serious interactions noted in regulatory documents are with other prescription drugs, specifically organic nitrates and guanylate cyclase stimulators. Patients are also warned not to use Sildenafil with other PDE5 inhibitors.


Q: Are there any known food restrictions or dietary considerations with Defil?

A high-fat meal is documented to reduce the rate and extent of the medicine's absorption. Additionally, grapefruit juice is restricted for patients taking the PAH formulation (Revatio).


Q: How can I find a complete, official list of known drug interactions for Defil?

The complete, detailed list of drug interactions can be found in the Full Prescribing Information and Patient Information documents. These are the official documents provided by the manufacturer and the FDA.


Q: Is Defil approved for use in children or teenagers?

Sildenafil is not indicated for Erectile Dysfunction in pediatric patients. Use for Pulmonary Arterial Hypertension in children is generally not recommended due to studies linking higher doses to potential mortality concerns.


Q: Is Defil appropriate for someone who also has a heart condition?

The medicine is formally contraindicated for patients taking nitrates. Use also requires caution in populations with a recent history of stroke or heart attack within the last six months, or those with severe cardiovascular disorders.


Q: Where can I find the official prescribing information document for Defil?

The official documentation is contained in the Full Prescribing Information and the Patient Information Leaflet. These documents provide the comprehensive, regulatory-approved details about the drug.


Q: Why might some patients not feel like Defil is working for them?

Official information indicates that absorption may be reduced if the medicine is taken with a high-fat meal. Lack of efficacy can also be related to a patient’s underlying medical condition or individual variability, as research does not guarantee an individual response.


Q: Why would a healthcare provider suggest Defil instead of a non-drug treatment?

Clinical trials reported patterns of efficacy or improvements in functional measures, such as the IIEF for ED and the 6MWD for PAH, in patients receiving Sildenafil compared to those receiving placebo for its approved indications.

How should Defil be stored and disposed of?

Storage and Handling

Defil (Sildenafil) oral tablets must be stored at Controlled Room Temperature, which is officially defined as 20 C to 25 C (68 F to 77 F). The product must be kept in the container it came in and the cap must remain tightly closed to protect the tablets from moisture and heat. Temperature excursions between 15 C and 30 C are permitted, but freezing should be avoided. The medicine must always be stored out of the sight and reach of children to prevent accidental ingestion.

Disposal Instructions

To dispose of expired or unused tablets, the official guidance is to utilize a drug take-back program or an authorized collection site. If these options are unavailable, the medicine can be mixed with an unappealing substance, placed in a sealed bag, and discarded in the household trash. Tablets must not be flushed down a toilet or poured down a sink.

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

Available in countries:

Equivalent of Defil found in:

A-Z Index: