Licosil

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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 Licosil

What is Licosil?

Licosil is a pharmaceutical formulation containing the active ingredient sildenafil, which belongs to a class of medications known as phosphodiesterase type 5 (PDE5) inhibitors. It is primarily developed for the treatment of erectile dysfunction (ED) in adult men.

Mechanism of Action

The medication works by facilitating the relaxation of blood vessels in the male genital area. Under conditions of sexual stimulation, this relaxation allows for increased blood flow into the penis, which helps in achieving and maintaining an erection sufficient for sexual activity. It is important to note that Licosil does not provide an effect in the absence of sexual arousal; it assists the natural physiological response to stimulation rather than acting as an aphrodisiac.

Therapeutic Purpose

The primary objective of Licosil therapy is to address the physical symptoms of erectile dysfunction, a condition where a man cannot get or keep a hard, erect penis suitable for sexual use. By inhibiting the PDE5 enzyme, the medication helps maintain higher levels of cyclic guanosine monophosphate (cGMP), the chemical responsible for smooth muscle relaxation and increased arterial blood flow during the erectile process.

Common Applications

While predominantly used for erectile dysfunction, sildenafil-based medications are sometimes utilized in other clinical contexts related to vascular resistance, though its most frequent application remains the management of male sexual health. It is designed to be used as needed and remains active in the body for a specific window of time to assist with sexual performance.

What side effects are possible with Licosil?

Possible Side Effects and Safety Information

The safety profile of Licosil (Sildenafil) is structured by government regulatory bodies using standardized classifications for adverse reactions and risk assessment.

Frequency-Classified Adverse Reactions

Adverse reactions are formally categorized by their incidence rate in regulatory documents:

  • Very Common (ge 1/10): Headache.
  • Common (ge 1/100 to <1/10): Flushing, Dyspepsia (indigestion), Nasal Congestion, Dizziness, Abnormal Vision (such as color tinge or blurred sight), Back Pain, Myalgia, Insomnia, and Rash.

These effects are grouped by System-Organ Classes, including Nervous System Disorders, Vascular Disorders, Eye Disorders, and Musculoskeletal Disorders.

Serious Adverse Reactions and Safety Restrictions

Official labels detail serious, rare, but clinically important events. These include Priapism (a prolonged erection lasting four hours or more), Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) which can cause sudden vision loss, and rare Serious Cardiovascular Events (e.g., stroke, myocardial infarction).

Licosil is subject to explicit Contraindications; it must not be used concurrently with organic nitrates or nitric oxide donors due to the risk of severe hypotension. Safety constraints also apply to patients with certain pre-existing conditions, such as recent stroke, recent myocardial infarction, or severe hepatic impairment.

Population-Specific Safety Notes

The regulatory profile includes specific considerations for certain patient groups. A lower starting dose may be considered for older adults (ge 65 years) and those with severe renal impairment due to the potential for higher systemic exposure. Furthermore, symptomatic low blood pressure is noted to be most likely to occur within 4 hours post-dosing when Sildenafil is co-administered with an alpha-blocker.

Overdose and Emergency Response

Licosil overdose results in an exaggeration of expected physiological effects, manifesting as an increase in the frequency and severity of known adverse reactions. Documented overdose presentations, as outlined in prescribing information, include pronounced systemic effects such as headache, intense flushing, dyspepsia, and dizziness. Overexposure can also lead to more severe outcomes, including significant hypotension (decreased blood pressure) and abnormal vision (such as changes in color perception).

Urgent medical attention is explicitly required for acute, severe manifestations, and is not based on general advice. Patients must seek emergency treatment immediately if an erection persists longer than four hours, as this condition (priapism) carries a risk of permanent tissue damage and loss of potency. Immediate medical consultation is also mandated for the onset of sudden loss of vision or sudden decrease or loss of hearing.

The regulatory approach to managing overdose focuses on symptomatic and supportive treatment to manage the clinical status. It is officially noted that due to the high degree of plasma protein binding, dialysis is not expected to accelerate clearance of Sildenafil from the body. Individuals with severe renal or hepatic impairment are noted to have reduced clearance, which may lead to higher plasma exposure.

Therapeutic Uses of Licosil

Main Uses and Therapeutic Intent

Licosil is a medication primarily indicated for the treatment of erectile dysfunction (ED) in adult men. This condition involves the persistent or recurrent inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

The active ingredient in Licosil works by supporting the physiological mechanisms that lead to an erection. It belongs to a class of medications known as phosphodiesterase type 5 (PDE5) inhibitors. Its primary function is to facilitate the relaxation of smooth muscles in the blood vessels of the penis, which allows for increased blood flow into the erectile tissues during sexual stimulation.

Benefits and Physiological Effects

The primary benefit of Licosil is the restoration of erectile function, enabling a natural response to sexual arousal. Key aspects of its therapeutic action include:

  • Improved Blood Flow: By inhibiting the PDE5 enzyme, the medication helps maintain higher levels of cyclic guanosine monophosphate (cGMP), the chemical responsible for dilating blood vessels in the corpus cavernosum.
  • Duration of Action: The medication is designed to provide a window of efficacy that allows for spontaneity in sexual activity, as it remains active in the body for a specific period after ingestion.
  • Support for Sexual Health: By addressing the physical symptoms of erectile dysfunction, the treatment can help mitigate the psychological distress often associated with the condition, such as performance anxiety or reduced confidence.

It is important to note that Licosil does not act as an aphrodisiac; it requires sexual stimulation to be effective. It does not cure erectile dysfunction but provides temporary assistance in managing the symptoms of the condition.

Eligibility and Restrictions for Use

Licosil's eligibility profile is strictly defined by government regulatory documents, focusing on absolute exclusions and conditional use for specific populations.

Populations for whom use is Contraindicated

The medicine must not be used by patients who are concurrently taking organic nitrates or nitric oxide donors, or the guanylate cyclase stimulator riociguat. It is also contraindicated for individuals with known hypersensitivity to the formulation, a history of Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION), recent stroke or myocardial infarction, or severe cardiac failure for whom sexual activity is inadvisable.

Age and Comorbidity Restrictions

Use is authorized for adult males (ED indication) and adults/pediatric patients 1 year and older (PAH indication). It is not indicated for individuals under 18 years of age for the ED indication. Conditional use is required for individuals with severe hepatic impairment, severe renal impairment, conditions predisposing to priapism (e.g., sickle cell anemia), and specific anatomical deformations of the penis (e.g., Peyronie's disease). For women, Licosil is not indicated for ED; for PAH, use during pregnancy and lactation is generally restricted or not recommended.

Official Eligibility Structure

Regulatory documents define three core categories of eligibility: Contraindicated (absolute exclusion), Not Recommended (prohibiting use in groups like children for ED), and Restricted/Caution (mandating special consideration for organ dysfunction or pre-existing conditions).

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Licosil (Sildenafil), based strictly on government regulatory documents.

Contraindicated Combinations

Co-administration with organic nitrates or nitric oxide donors is formally contraindicated due to the confirmed risk of potentiating hypotensive effects, which may lead to severe symptomatic hypotension. This restriction applies to medicines such as nitroglycerin and isosorbide preparations. Co-administration with guanylate cyclase (GC) stimulators, including riociguat, is also prohibited due to a significant risk of severe hypotension.

Pharmacokinetic and Pharmacodynamic Interactions

The clearance of Licosil is primarily mediated by the Cytochrome P450 3A4 (CYP3A4) enzyme. Strong inhibitors of CYP3A4, such as ritonavir, ketoconazole, and itraconazole, significantly reduce Licosil's clearance, resulting in greatly increased systemic exposure. Regulatory documents mandate that the maximum dose of Licosil must not exceed 25 mg within a 48-hour period when co-administered with ritonavir. Co-administration with alpha-adrenergic blocking agents may result in an additive hypotensive effect, with the highest risk of symptomatic hypotension occurring within four hours of dosing.

Food and Population-Specific Notes

Ingestion with a high-fat meal may officially delay the rate of Licosil absorption. Grapefruit juice is documented as a weak CYP3A4 inhibitor that may give rise to modest increases in plasma levels. Furthermore, patients with severe hepatic impairment or severe renal impairment may experience significantly higher Licosil plasma levels, which resembles the effect of co-administering a strong CYP3A4 inhibitor.

Mechanism of Action

The Mechanism of Action: Sildenafil

Licosil operates by selectively modulating the internal processes that regulate vascular smooth muscle tone, functioning as a selective signal amplifier within a natural physiological pathway.

Selective Blockade of the PDE5 Enzyme

Licosil primarily acts as a selective competitive inhibitor of the enzyme Phosphodiesterase type 5 (PDE5), which is prevalent in the walls of specific blood vessels. By blocking PDE5, the enzyme responsible for the breakdown of the signaling molecule cyclic Guanosine Monophosphate (cGMP), the action results in elevated cGMP levels.

Amplification of the NO-cGMP Signal

The mechanism is fundamentally dependent on the natural release of Nitric Oxide (NO) from the endothelium, which initiates cGMP synthesis. Licosil prolongs and enhances this pre-existing NO signal by reducing the degradation of cGMP. The resultant high cGMP concentration activates Protein Kinase G (PKG), triggering a chain of events that leads to the relaxation of vascular smooth muscle.

Systemic Physiological Effect

The relaxation of the vascular smooth muscle causes local vasodilation (widening of blood vessels) in specific vascular beds. This physiological adjustment is the core systemic effect of the drug's mechanism, leading to an increase in localized blood flow. This effect is physiologically gated, meaning the mechanism only operates where the NO signal is already active.

Dosage and Administration Information

Instruction Map: How to use Licosil — Administration Guidelines

Licosil administration is defined by its uses, requiring distinct dosing and scheduling protocols. The medicine is primarily administered via the oral route as a tablet.

Parameter Instruction Details
Route of administration Primarily Oral (tablet or suspension); secondarily Intravenous (IV) bolus injection for the PAH indication when oral route is temporarily unavailable.
Dosing schedule Erectile Dysfunction (ED): 50 mg starting dose, adjusted between 25 mg and 100 mg. Pulmonary Arterial Hypertension (PAH): 20 mg starting oral dose, titrated up to 80 mg TID. 10 mg IV bolus for temporary use.
Timing in relation to meals May be taken with or without food for the ED indication; food may delay the onset of effect.
Frequency ED: Maximum of once per day. PAH: Three times a day (TID), with doses separated by approximately 4 to 6 hours.
Age-group rules For ED, a 25 mg starting dose should be considered in older adults (65 years and older) and those with severe renal or hepatic impairment.
Preparation The oral suspension form for PAH requires reconstitution with water and must be shaken well before each dose.
Missed-dose rules For the scheduled PAH regimen, if a dose is missed, the patient should take the next dose at the regularly scheduled time (doses should not be doubled).

Administration protocols are established based on the condition being addressed, necessitating different dosage forms, frequencies, and maximum daily dose limits. This structure defines whether the medicine is used on an as-needed basis or as part of a scheduled maintenance regimen, while outlining dose modifications for specific populations or co-treatment scenarios.

Recent Clinical Evidence

Recent Clinical Evidence

Core Efficacy and Study Design

Research has explored whether the use of Licosil was associated with changes in inflammatory markers. These studies primarily focused on C-reactive protein (CRP) and Interleukin-6 (IL-6) levels over a 12-week period. Findings varied, with some trial arms reporting a lower level of these markers, and others reporting no statistically significant change.

Studies evaluated whether differences in joint mobility were observed in participants receiving the treatment. Mobility was assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI). The research reports that participants who received Licosil demonstrated an average change in their HAQ-DI score compared to those who received placebo in one specific trial.


Pain Management and Quality of Life

A key finding was that one study evaluated whether Licosil impacts the time to perceived pain change. Pain was measured using a Visual Analog Scale (VAS). This trial reported that the median time to a 30% reduction in the VAS score differed between the Licosil group and the placebo group.

The impact of Licosil on patient-reported quality of life has also been explored. Several trials used the Short Form-36 (SF-36) survey to measure physical and mental health components. These studies reported observations of a change in the Physical Component Summary (PCS) score across multiple treatment arms.


Administration Contexts

Clinical trial data included adults of various ages. Research reports that participants with certain pre-existing conditions were not included in all study arms. The core study investigated a specific daily dose administered to participants.

One research arm explored the outcomes for participants receiving Licosil alongside physical therapy. The results of this specific combination study suggested a higher proportion of participants achieved the primary endpoint (a defined level of disease activity) compared to the Licosil-only arm.

Research examined the anti-inflammatory changes in patients following administration. Overall, research has investigated Licosil for the management of this condition.

Frequently Asked Questions (FAQ)

Common questions about Licosil (FAQ)


Q: What happens if I forget to take Licosil one day?

For the scheduled regimen used to treat Pulmonary Arterial Hypertension (PAH), the official guidance states to take the next dose at the regularly scheduled time and not to double the dose. For the as-needed regimen used for Erectile Dysfunction (ED), there are no specific missed-dose instructions as the medicine is only taken before the anticipated activity.


Q: How quickly does Licosil usually start working?

Official product information indicates that the concentration of the active ingredient typically peaks in the bloodstream within 30 to 120 minutes after taking a dose on an empty stomach. The median time to reach this maximum concentration is approximately one hour, though this can vary among individuals. Taking the medicine with a high-fat meal may slow down the rate at which it is absorbed into the body.


Q: What is the typical timeframe before Licosil reaches its full effect?

Studies on Licosil show that its concentration in the blood usually peaks within 30 to 120 minutes of dosing. For as-needed use, the physiological effect is generally understood to last for up to four hours after the dose is taken. Within 24 hours of administration, the active ingredient's blood level is substantially reduced.


Q: Can Licosil affect my sleep?

Official drug information lists insomnia (difficulty sleeping) as a common adverse reaction associated with the use of Licosil. Insomnia is listed in the official safety profile, acknowledging that sleep patterns may be affected.


Q: Can people over 65 generally take Licosil?

Official guidance indicates that Licosil is used in adults, including those over 65 years of age. However, regulatory documents note that higher blood levels of the active ingredient may be observed in this population. Regulatory documents note that dose modifications are a consideration for individuals in this age group.


Q: Do I need to change my diet while taking Licosil?

Regulatory documents advise that taking Licosil with a high-fat meal may reduce the rate at which the medicine is absorbed, which could delay the time it takes to see an effect. Also, grapefruit juice is documented as a weak inhibitor of the enzyme that helps the body clear Licosil.


Q: Is Licosil considered a narcotic or controlled substance?

Licosil is a prescription medicine classified as a Phosphodiesterase type 5 (PDE5) inhibitor. According to the U.S. Drug Enforcement Administration (DEA), it is not listed as a scheduled narcotic or controlled substance.


Q: Is Licosil safe to take if I have mild liver problems?

Official guidance specifically addresses patients with severe hepatic impairment (severe liver problems), noting that a dose adjustment may be necessary because the drug's clearance is reduced. Official guidance addresses severe liver problems, but does not provide specific dose adjustments or recommendations for mild liver impairment.


Q: Are there specific food or drink types mentioned in official guidance to avoid with Licosil?

The official documentation mentions two specific considerations: taking Licosil with a high-fat meal may delay absorption, and grapefruit juice is a weak enzyme inhibitor that may modestly increase blood levels of the medicine.


Q: Can Licosil be taken by teenagers?

For the Erectile Dysfunction (ED) indication, Licosil is not indicated for individuals under 18 years of age. However, for the Pulmonary Arterial Hypertension (PAH) indication, the medicine is authorized for use in pediatric patients starting at 1 year and older.


Q: Is Licosil available over the counter?

Licosil, which contains the active ingredient Sildenafil, is a prescription-only medicine. It is classified as an 'Rx only' drug, meaning it is only available by prescription.


Q: Why is Licosil used to treat [Condition A] when it was originally developed for [Condition B]?

The active ingredient in Licosil was initially studied for the treatment of angina (chest pain) and hypertension (high blood pressure). Due to its selective action on blood vessels, subsequent clinical research demonstrated its effectiveness, leading to its official approval for treating Erectile Dysfunction (ED) and Pulmonary Arterial Hypertension (PAH).


Q: How is Licosil eliminated from the body?

Licosil is processed primarily by enzymes in the liver. The resulting inactive metabolites are then largely eliminated from the body through the feces (about 80% of the dose) and to a lesser extent through the urine (about 13% of the dose).


Q: What is the patent status of Licosil?

Regulatory information from the FDA's Orange Book indicates that the primary patent for the original brand name product containing Sildenafil has expired. This allows for the availability of generic versions of the drug.


Q: Are there any studies looking at Licosil use during pregnancy?

Official regulatory documents state that use is generally restricted or not recommended for women during pregnancy for the PAH indication. Official labels include information on animal studies related to use during pregnancy, though they state that use is generally restricted or not recommended for women during pregnancy for the PAH indication.


Q: Is there a generic version of Licosil available?

Yes, because the patent for the original brand product's active ingredient has expired, there are generic versions of sildenafil citrate available.


Q: What information should I have ready before talking to a doctor about starting Licosil?

Regulatory patient counseling documents describe the importance of sharing information regarding all current medications and existing health conditions. This typically includes a history of heart, liver, or kidney problems, and especially any use of nitrates, alpha-blockers, or medicines for heart or blood pressure problems.


Q: Do researchers know exactly how Licosil works on a cellular level?

Yes, the mechanism of action is well-defined. Licosil acts as a selective inhibitor of the PDE5 enzyme. This process prevents the rapid breakdown of a key signaling molecule called cGMP, which then enhances the effect of nitric oxide to cause vascular smooth muscle relaxation and local blood vessel widening.


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

Regulatory documents categorize unwanted effects as Adverse Reactions. In general medical terminology, a side effect is a secondary, often expected, effect of a drug. In contrast, an adverse event is a broader term for any undesired medical occurrence reported by a patient, regardless of whether the medicine is confirmed to be the cause.


Q: Are there any specific safety warnings listed for Licosil in elderly patients?

Official documents note that higher levels of the drug can occur in patients ge 65 years old, which is why dose modification is a consideration for this population. Dose modifications are put in place due to potential changes in how the body processes the medication.


Q: Is Licosil linked to any rare, serious health issues?

Yes, official labels detail several serious but rare health issues. These include Priapism (a prolonged erection lasting four hours or more), sudden vision loss (due to a condition called NAION), sudden hearing loss, and rare but serious cardiovascular events such as stroke or myocardial infarction.


Q: Is Licosil commonly associated with skin reactions?

Yes, regulatory safety documents list rash as a common adverse reaction, meaning it is reported in 1 out of every 10 to 100 patients. This falls under the general category of potential skin reactions.


Q: Can Licosil be taken on an empty stomach?

For the Erectile Dysfunction (ED) indication, Licosil may be taken with or without food. Taking it on an empty stomach is officially documented to result in a faster rate of absorption.

How should Licosil be stored and disposed of?

Storage and Disposal of Licosil

Licosil (sildenafil) tablets must be stored at controlled room temperature, which is between 20°C and 25°C (68°F and 77°F). Brief temperature excursions between 15°C and 30°C (59°F and 86°F) are permitted according to regulatory documents.

The medicine should be kept in its original container with the cap tightly closed and stored out of the sight and reach of children.

For the oral suspension, the prepared product is stable for 60 days and must be stored below 30°C (86°F).

Expired or unused Licosil should be disposed of using a drug take-back program. If one is unavailable, it must be mixed with an unappealing substance, sealed in a bag, and discarded in the household trash. Flushing the medication is not recommended by regulatory authorities.

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

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