Daygra

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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 Daygra

Quick Facts

Property Description
Active ingredient Sildenafil
Form Film-coated tablet (Oral preparation)
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
General purpose Management of conditions requiring facilitated blood flow
Origin Synthetic (Pyrazolopyrimidinone derivative)

What Type of Medicine is Daygra?

Daygra is a synthetic, prescription-only pharmaceutical preparation designed for systemic therapeutic use, identified by its active component, Sildenafil. The product is typically presented as a film-coated tablet, which makes it a solid oral preparation intended for efficient absorption into the body.

The active ingredient, Sildenafil citrate, is a pyrazolopyrimidinone derivative, signifying its specific chemical origin and structure. This preparation is a single-active ingredient product, or monotherapy. The oral administration of the robust tablet form provides a method for delivering the vasoactive agent into the bloodstream, a delivery method recognized for its predictable systemic effect in this class of medication.

Daygra’s Pharmacological Class and Action

Daygra is categorized pharmacologically as a selective inhibitor belonging to the Phosphodiesterase type 5 (PDE5) inhibitor class. This classification establishes the drug as a targeted agent that works by modulating specific vascular enzymes within the body. Sildenafil’s primary function is to block the enzyme responsible for regulating blood flow in certain areas.

The fundamental action involves inhibiting the PDE5 enzyme, which prevents the rapid breakdown of a signaling molecule necessary for smooth muscle relaxation in blood vessel walls. This selective inhibition facilitates vasodilation, allowing for increased and sustained blood flow. This mechanism is key to the drug's therapeutic application, as this action helps promote necessary blood vessel widening for improved function.

The General Therapeutic Purpose of Daygra

The overarching purpose of Daygra is to manage conditions where improved or restored circulation is therapeutically necessary, leveraging its action as a vasoactive agent to facilitate functions reliant on adequate blood flow. It is employed to manage sexual dysfunction in adult males and is also indicated for the treatment of certain forms of pulmonary arterial hypertension in patients with specific vascular disorders. This use reflects the drug's specialized function in modulating the vascular system, thereby helping to improve physiological function compromised by restricted blood flow.

Regulatory References

  1. NIH MedlinePlus Sildenafil Information

What side effects are possible with Daygra?

Possible Side Effects and Safety Information

The safety profile of Daygra (Sildenafil) is officially documented by classifying adverse reactions based on their frequency and the body system affected, consistent with regulatory standards.

Frequency-Classified Adverse Reactions

The most frequently observed adverse reaction, classified as Very Common (ge 1/10), is headache. Adverse effects classified as Common (ge 1/100 to < 1/10) include flushing, dyspepsia (indigestion), nasal congestion, and visual colour distortions or blurred vision.

System and Serious Adverse Reactions

Reactions are grouped into system-organ classes, such as Vascular Disorders (flushing, changes in blood pressure) and Eye Disorders (visual disturbances). The regulatory label documents rare but serious adverse reactions reported primarily through post-marketing surveillance. These include Priapism (a prolonged erection lasting more than four hours), sudden decrease or loss of hearing, and rare cardiovascular events such as myocardial infarction or sudden cardiac death.

Safety Restrictions and Population Considerations

Sildenafil has systemic vasodilatory properties that cause transient decreases in blood pressure. Use is strictly contraindicated with co-administration of nitrates or nitric oxide donors in any form due to the risk of severe hypotension. Safety statements also note the contraindication in patients with a recent history of stroke or myocardial infarction, and in those with known hereditary degenerative retinal disorders. Additionally, chronic use in pediatric patients for pulmonary conditions is not recommended due to safety concerns documented in that specific population.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory documentation states that overdose of Daygra (Sildenafil) is primarily characterized by a significant increase in the rate and severity of adverse events already observed at lower, therapeutic doses. Documented clinical manifestations of excessive exposure, which was observed in studies involving single doses up to 800 mg, may include decreased blood pressure, syncope (fainting), and prolonged erection (Priapism).

Severe Outcomes and Mandated Emergency Actions

The highest regulatory concern is tied to the risk of Priapism, which, if unmanaged, can lead to severe, irreversible outcomes such as penile tissue damage and permanent loss of potency.

The following actions are mandated in official prescribing information:

  • Seek immediate medical assistance for an erection that persists longer than four hours.
  • Seek immediate medical care if there is a sudden loss of vision in one or both eyes.
  • Seek prompt medical attention in the event of sudden decrease or loss of hearing.

Overdose Management

Management of overdose is symptomatic and supportive to maintain vital functions, as no specific antidote is known. Due to the high plasma protein binding of Sildenafil, renal dialysis is not expected to accelerate clearance of the drug from the body.

Therapeutic Uses of Daygra

What Daygra Treats: Main Uses and Benefits

The primary therapeutic applications of Daygra (Sildenafil) are commonly used in conditions characterized by periods of heightened symptoms. The medication is applied across two distinct therapeutic domains.


Management of Erectile Dysfunction (ED) Symptoms

Daygra is commonly used for managing Erectile Dysfunction in adult males, addressing the core symptom of an inability to achieve or maintain a penile erection. It helps address symptom clusters that interfere with daily comfort, and may become disruptive during intimate encounters. This supportive relief generally may assist with maintaining functional stability during moments of sexual arousal. The therapeutic relevance applies across two main condition categories: Erectile Dysfunction and certain presentations of Pulmonary Arterial Hypertension.

Supportive Management of Pulmonary Arterial Hypertension (PAH)

The medication is also considered relevant for easing symptoms related to systemic imbalance that arise from Pulmonary Arterial Hypertension. This is a condition involving episodic or fluctuating manifestations marked by increased physiological stress. In this context, Daygra contributes to easing the overall symptom load by managing symptoms linked to organ-specific functional stress. This helps maintain a sense of stability and supports the patient's exercise tolerance during symptomatic periods.


“The medication is applied across domains where additional symptomatic support is needed, assisting with symptom clusters that create noticeable physiological strain.”


Quick Facts: Therapeutic Relevance

Fact Description
ED Symptom Axis Inability to achieve or maintain an adequate erection.
PAH Symptom Axis Reduced exercise capacity and shortness of breath.
Patient Benefit Provides supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH National Library of Medicine overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Daygra?

The population eligibility for Daygra (Sildenafil) is strictly governed by regulatory labeling, which defines both allowed and prohibited use across different groups.

Populations for Whom Use is Contraindicated

Daygra must not be used by patients taking nitric oxide donors or organic nitrates in any form (e.g., nitroglycerin), due to the risk of severe hypotension. Use is also contraindicated in patients taking soluble guanylate cyclase (sGC) stimulators.

Non-eligibility is also defined by certain conditions: the medicine is prohibited for patients with a recent stroke or myocardial infarction (within the last six months), severe unstable cardiovascular disorders, severe hepatic impairment, or a history of non-arteritic anterior ischemic optic neuropathy (NAION).

Age and Condition Restrictions

Category Eligibility Rule
Indicated Groups Adult males for Erectile Dysfunction (ED) and adults/pediatrics (ages 1–17) for Pulmonary Arterial Hypertension (PAH).
Pediatric Use Not recommended for the ED indication; approved only for specific PAH protocols.
Organ Function Patients with severe renal impairment should consider a reduced starting dose due to altered drug clearance.
Reproductive Status Use in women, including during pregnancy or lactation, is generally not indicated for the ED purpose. Use during pregnancy for PAH requires careful assessment.

Regulatory documentation requires caution for patients prone to priapism (e.g., sickle cell disease) or those with anatomical deformation of the penis.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail specific drug-drug and substance interactions for Daygra (Sildenafil) that influence its use and necessary administrative restrictions.

Contraindicated Combinations

Formal restrictions prohibit the co-administration of Daygra with certain drug classes due to the risk of severe pharmacodynamic effects:

  • Organic Nitrates (in any form) are contraindicated because Sildenafil is documented to potentiate their hypotensive effects, resulting in the risk of critically low blood pressure.
  • Guanylate Cyclase (GC) Stimulators (e.g., Riociguat) are also contraindicated due to the potential for symptomatic hypotension caused by additive blood pressure lowering effects.

Pharmacokinetic and Exposure Modifications

The primary metabolic pathway involves the enzyme CYP3 A4. Interactions that affect this enzyme lead to altered drug exposure:

  • Strong CYP3 A4 Inhibitors (e.g., Ritonavir, Ketoconazole) cause a significant increase in Sildenafil plasma levels due to reduced clearance. Regulatory constraints dictate a maximum restricted dose when used with Ritonavir (e.g., 25 mg within a 48 hour period).
  • Moderate-to-Strong CYP3 A Inducers (e.g., Bosentan) are noted to decrease Sildenafil exposure.

Other Documented Interactions

  • Alpha-Blockers (used for hypertension or prostate issues) present an officially documented risk of additive hypotensive effects; the maximum risk of symptomatic low blood pressure is noted to occur within four hours post-administration.
  • Oral Vitamin K Antagonists are associated with a reported increase in the incidence of epistaxis (nosebleeds) when co-administered.
  • Population Notes: Patients aged over 65 and those with severe renal or hepatic impairment exhibit slower clearance, resulting in documented higher plasma levels of Sildenafil, which may magnify other interaction effects.

Mechanism of Action

How Daygra Works: The Mechanism of Action


Selective Inhibition of the PDE5 Enzyme

Daygra's mechanism involves its action as a selective competitive inhibitor targeting the Phosphodiesterase type 5 (PDE5) enzyme, which is highly concentrated in the vascular smooth muscle cells of specific arterial beds. The inhibition of this enzyme is the primary molecular action that blocks the hydrolysis of the second messenger, cyclic Guanosine Monophosphate (cGMP). This prevention maintains elevated cGMP concentrations within the cell.


Potentiation of Local Vascular Signaling

The mechanism acts to potentiate the natural Nitric Oxide (NO)-cGMP signaling pathway. The drug effectively prolongs the physiological signal by preventing cGMP degradation, leading directly to the relaxation of the vascular smooth muscle and a consequential reduction in localized vascular resistance.


Modulating Localized Vascular Haemodynamics

The combined molecular action ultimately leads to a localized modulation of vascular haemodynamics. This physiological adjustment, specifically the widening of arteries (vasodilation) in the targeted regions, facilitates increased local haemodynamic flow.

Dosage and Administration Information

Daygra (Sildenafil) is administered through two approved routes: oral (using tablets or suspension) and intravenous (IV) injection. The specific dosing and frequency patterns are governed by distinct administration schedules.

Administration Patterns

For Intermittent Use, the medicine is taken as needed with a maximum frequency of once per day. The typical starting dose is 50 mg, which may be adjusted within the range of 25 mg to 100 mg as a single dose. This formulation is often taken 30 minutes to 4 hours prior to use, and a high-fat meal can delay the onset of action.

For Chronic Use, the drug follows a scheduled regimen of 20 mg taken three times daily (TID). These doses are generally administered approximately 4 to 6 hours apart and can be taken with or without food. The IV injection route is reserved for patients temporarily unable to receive the oral formulation.

Dose Adjustments and Procedural Notes

Specific procedural rules apply to ensure proper use. Older adults (age 65 years and over) and individuals with severe hepatic or renal impairment should consider a lower starting dose of 25 mg for intermittent use. Furthermore, an explicit administration constraint states that the 20 mg chronic-use tablets must not be used concurrently with the higher-strength intermittent-use tablets. If a dose is missed on the chronic TID schedule, the dose should not be doubled to compensate.

Recent Clinical Evidence

Research evidence / Overview of studies for Daygra

Evidence for Use in Erectile Dysfunction (ED) in Adult Males

The research base for Daygra's use in Erectile Dysfunction (ED) is built upon numerous short-term, randomized, double-blind, placebo-controlled clinical trials (RCTs). These studies were conducted to determine the patterns observed in men experiencing ED symptoms. Researchers tracked outcomes related to physical discomfort and outcomes describing episodic changes, primarily using standardized patient questionnaires (like the IIEF-EF) and monitored the documentation of successful sexual intercourse attempts. However, long-term effects are not fully established by controlled data, and comparative evidence is lacking as most pivotal trials used a placebo comparator.


Evidence for Use in Pulmonary Arterial Hypertension (PAH)

Research exploring Daygra's application in Pulmonary Arterial Hypertension (PAH) involves randomized, placebo-controlled trials, often lasting several months. Studies monitored functional capacity, focusing on standardized measures like the Six-Minute Walk Distance (6MWD), and tracked events related to the time to clinical worsening. Studies reported data show patterns related to the 6MWD from baseline between the study groups, and monitored the occurrence of clinical worsening events. A key uncertainty relates to long-term survival, as large-scale RCTs powered for all-cause mortality are limited.


Long-Term Evidence, Special Populations, and Uncertainties

The follow-up durations in primary trials were typically limited, meaning there is insufficient information for long-term outcomes and maintenance of reported changes under controlled conditions. Data on sustained change often comes from open-label extension studies where evidence quality varies. Research was evaluated in special populations, including men with coexisting conditions like diabetes and hypertension, and dedicated studies examined pediatric patients with PAH. Regulatory bodies have highlighted data complexity and uncertainty regarding long-term outcomes in specific pediatric cohorts. Across both indications, results apply only to the populations studied, and comparative evidence against other active treatments remains limited.

Key Studies & References

  1. Label: SILDENAFIL tablet, film coated - DailyMed (FDA-mandated PAH labeling updates and warnings)

Frequently Asked Questions (FAQ)

Common questions about Daygra (FAQ)


Q: How quickly is Daygra expected to start working?

According to official product information, Daygra's onset of action is typically reported to occur within 30 to 60 minutes after being taken orally without food. As with most medications, the time taken to observe effects may vary from one person to another.


Q: How long does the effect of Daygra generally last?

Regulatory documents indicate that the therapeutic effects of a single dose of Daygra are generally reported to last for up to 4 hours. However, the drug's effect is often noted to be less pronounced after the first two hours following administration.


Q: Do I need to eat food when I take Daygra?

Official guidance describing food interaction varies based on the administration schedule. For intermittent use (taken as needed), consuming a high-fat meal may delay the time it takes for the medicine to start working. For chronic, scheduled use, the tablets can be taken with or without food, as documented in the product information.


Q: Can Daygra affect my ability to drive or operate machinery?

Official guidance advises that Daygra may cause side effects such as dizziness or visual disturbances, including blurred vision. Regulatory warnings indicate that individuals should note any side effects before performing activities such as driving or operating machinery.


Q: What are the official guidelines about drinking alcohol while using Daygra?

Official regulatory information advises caution regarding alcohol consumption. Using Daygra with large amounts of alcohol can potentially increase the risk of certain side effects, such as a drop in blood pressure or dizziness. Official information indicates that excessive alcohol intake can potentially compromise the expected physiological response to the medication.


Q: Is Daygra safe to use for older people (e.g., over 65)?

Official documents describe that use in older adults (over 65 years) is addressed in the regulatory label. Procedural rules indicate that a lower starting dose is often considered due to documented changes in the body's drug clearance (how quickly the body removes the drug).


Q: What if I'm already taking multiple different medications—is Daygra still okay?

Regulatory documents emphasize the need for caution when Daygra is used alongside multiple medications. This is particularly true for other drugs that may affect blood pressure. Official information lists specific drug classes that are strictly contraindicated or require dose adjustments due to the risk of additive effects.


Q: Is Daygra the same kind of drug as similar medicines?

Daygra's active ingredient, Sildenafil, is classified as a Phosphodiesterase type 5 (PDE5) inhibitor. This classification is shared by other medicines used for related purposes, meaning they belong to the same pharmacological class and share a general mechanism of action by modulating a specific vascular enzyme.


Q: Is Daygra considered a high-risk medication by regulators?

Regulatory bodies classify Daygra as a prescription-only medicine (POM), which requires use to be supervised by a healthcare professional. Its use is controlled because it has a defined safety profile that includes well-documented serious adverse reactions, requiring strict adherence to contraindications.


Q: Are there any reported differences in how Daygra works for men versus women?

Official documents confirm that Daygra is indicated for Pulmonary Arterial Hypertension (PAH) in both men and women. However, the regulatory indication for Erectile Dysfunction (ED) is specifically restricted to adult males.


Q: Does Daygra have a potential for dependence or addiction?

According to official regulatory documents and supporting medical reviews, Daygra is not classified as physically addictive or habit-forming. It is not listed as a controlled substance by major government drug agencies.


Q: Where can I find the official patient information leaflet for Daygra?

The official Patient Information Leaflet (PIL), also known as the Patient Package Insert (PPI) or Consumer Medication Information (CMI), can be accessed directly from the official websites of government regulatory bodies that oversee the drug's use, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).


Q: Is it true that Daygra can change the way some other medications are absorbed?

Official information confirms that Daygra is primarily metabolized (broken down) by the liver enzyme CYP3A4. This process means that other medications which affect this enzyme can change Daygra's concentration in the bloodstream, altering its duration of action.


Q: Does Daygra cause tiredness or fatigue?

Regulatory documents list certain central nervous system effects in the side-effect profiles. These include adverse reactions such as dizziness, somnolence (drowsiness), and insomnia (difficulty sleeping), which are reported as common or uncommon effects.


Q: Can Daygra affect my sleep patterns?

Official regulatory documents list insomnia (difficulty sleeping) as a common adverse reaction, meaning it is reported in 1% to 10% of people. This indicates that Daygra can potentially affect sleep patterns.


Q: Are there any common skin reactions associated with Daygra?

Official regulatory documents list rash as a common adverse reaction, meaning it is reported in 1% to 10% of people using the drug. Other dermatological reactions, such as general redness (erythema), are also documented in official reports.


Q: What makes Daygra different from non-prescription supplements for the same purpose?

Daygra is a chemically defined, synthetic medicine classified as a PDE5 inhibitor that is available only by prescription. Unlike non-prescription supplements, Daygra is subject to strict regulatory approval requirements for safety, efficacy, and quality control by government drug agencies.


Q: What is the risk of developing a new medical issue while on Daygra?

Regulatory systems require the continual collection and reporting of all adverse reactions and new safety signals that may occur during the use of Daygra. These official safety updates, including rare but serious issues, are publicly documented by government bodies to monitor the drug's risk profile over time.


Q: Do any official warnings exist about taking Daygra with grapefruit juice?

Yes, official warnings or scientific reviews noted in regulatory documents mention that consuming grapefruit juice can potentially increase the concentration of Daygra in the bloodstream. This is due to its documented effect on the CYP3A4 enzyme, which is involved in metabolizing the drug.


Q: Are there different strengths or formulations of Daygra available?

Regulatory documents confirm that Daygra is manufactured in multiple oral tablet strengths (e.g., 20 mg, 25 mg, 50 mg, and 100 mg). It is also available in different formulations, specifically oral tablets and an intravenous (IV) injection preparation, depending on the indication.


Q: Does Daygra affect fertility or reproductive health?

Official regulatory documents contain summaries of non-clinical studies related to fertility. The label notes that use in women for the sexual dysfunction indication is generally not advised, and its use during pregnancy or lactation for PAH requires careful assessment.


Q: Is it required to take Daygra at the exact same time every day?

The timing requirements are based on the specific administration schedule outlined in the official documentation. For chronic conditions, a schedule like three times daily suggests the need for regular, spaced timing. For intermittent use, the medication is taken only 'as needed.'


Q: Has Daygra been approved for use in children or adolescents?

Official documents state that Daygra is approved for the treatment of Pulmonary Arterial Hypertension (PAH) in specific pediatric cohorts (children and adolescents). However, its use is not recommended for the Erectile Dysfunction (ED) indication in these age groups.


Q: Are there any long-term side effects that users should be aware of with Daygra?

Regulatory documents include rare but serious adverse reactions that have been reported primarily through continuous post-marketing surveillance. These reports, which include instances of sudden vision loss or hearing loss, are documented by government bodies to monitor the drug's long-term safety profile.


Q: Why is Daygra sometimes associated with changes in mood?

Official regulatory documents list several psychiatric adverse reactions as reported side effects. These include issues such as anxiety or insomnia (difficulty sleeping), which are documented to occur as side effects.


Q: Is Daygra effective for all patients who try it?

Clinical trial results reported in regulatory documents indicate that while the drug showed statistically significant results compared to placebo, the treatment response is documented to vary across individuals. Efficacy applies only to the populations studied in the trials.


Q: What were the primary endpoints in the main clinical trials for Daygra?

Regulatory documents specify the primary outcomes that were measured in the pivotal clinical trials. For the Erectile Dysfunction indication, this included patient questionnaires (e.g., the IIEF). For Pulmonary Arterial Hypertension, a key measure was the Six-Minute Walk Distance (6MWD).


Q: Is Daygra known to cause weight changes?

Regulatory documents list certain metabolic and nutritional effects as documented adverse reactions. These include reports of increased weight and fluid retention as common side effects, meaning they are reported in 1% to 10% of users.


Q: What organ systems does Daygra primarily affect?

The mechanism of action is focused on the vascular system by facilitating the relaxation of blood vessel walls. Official documents also note potential effects on the eye (visual disturbances) and the nervous system (e.g., headache and dizziness) due to the systemic nature of the drug.

How should Daygra be stored and disposed of?

How to Store and Dispose of Daygra

The storage and disposal of Daygra (sildenafil) must strictly follow the conditions outlined in official regulatory documents to maintain drug stability and ensure safety.

Storage Requirements

Requirement Condition (Regulatory Standard)
Temperature Store at controlled room temperature (typically 20 C to 25 C / 68 F to 77 F)
Protection Keep in the original container, tightly closed, and protect from moisture
Child Safety Keep out of the sight and reach of children

Disposal Instructions

Any unused or expired Daygra must be disposed of in accordance with local regulatory requirements. Official guidance recommends utilizing a drug take-back program when available. The medication should typically not be flushed down the toilet or poured down a drain.

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

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