Agram

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Medically reviewed

Laura Arias

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 Agram

What is Agram? (Overview)

Property Description
Active ingredient Sildenafil
Form Oral Tablet
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
General Purpose Improves localized blood flow
Origin Synthetic (chemically manufactured)

Sildenafil: Identity and Pharmacological Class

Agram is a brand name for a medication whose active component is Sildenafil, which is the universally accepted International Nonproprietary Name (INN). Sildenafil is classified as a Phosphodiesterase type 5 (PDE5) inhibitor, a pharmacological class known for its highly selective action on specific circulatory mechanisms.

This substance is a synthetic organic molecule, meaning it is entirely created through chemical synthesis rather than being naturally sourced. Sildenafil's unique feature is that it was the first medication of its kind approved for its primary therapeutic use, establishing a standard for subsequent PDE5 inhibitor formulations. This positions it as a foundational agent in this drug class.

Form, Composition, and Administration

The medication is most commonly supplied as an oral tablet and is taken by swallowing it, utilizing the oral route of administration. The single active ingredient is Sildenafil citrate.

As a single-entity drug, all of its clinical effects are attributable solely to the Sildenafil compound. The tablets also contain inactive excipients, such as binders and fillers, which are necessary to ensure a stable, appropriately sized, and absorbable pharmaceutical product.

General Therapeutic Principle

The core principle behind the drug's action is to relax the smooth muscles in the walls of blood vessels through enzyme inhibition. The primary general purpose of this action is to improve blood flow and circulation to specific areas of the body.

By enhancing the natural process of vasodilation (the widening of blood vessels), Sildenafil helps ensure that blood can circulate more effectively. This general benefit of boosting circulation is the high-level foundation for its role in clinical medicine.

Regulatory References

  1. as recognized by the NIH

What side effects are possible with Agram?

Possible Side Effects and Safety Information for Agram

The safety profile of Agram is defined by data collected from controlled clinical trials and post-marketing surveillance, classified according to governmental regulatory standards.

Adverse Reactions

The frequency of adverse reactions is categorized using standard medical terminology, such as Very Common (occurring in 10% or more of patients), Common (1% to 10%), Uncommon (0.1% to 1%), and Rare (less than 0.1%).

Adverse events most frequently reported across all System-Organ Classes (SOCs) involve Gastrointestinal disorders and Nervous system disorders. For example, Very Common adverse reactions often include nausea, vomiting, or headache. Other frequently observed effects may involve skin reactions like rash or pruritus.

Frequency Classification Examples of Adverse Reactions (System-Organ Classes)
Very Common Nausea, Vomiting, Headache (Gastrointestinal, Nervous System)
Common Dizziness, Fatigue, Mild Rash (Nervous System, General, Skin)
Uncommon Allergic reactions, Liver enzyme elevations (Immune System, Hepatic)

Serious and Clinically Significant Adverse Reactions

Certain reactions are classified as serious due to their potential for severe outcomes. These clinically significant adverse reactions, though rare, include severe hypersensitivity reactions (such as anaphylaxis) and reports of significant hepatotoxicity. Regulatory documents emphasize that these risks require immediate attention and may necessitate discontinuation of the treatment.

Safety Considerations and Restrictions

Population-Specific Safety: Caution and specific monitoring are documented for use in patient populations with renal or hepatic impairment, often requiring dose adjustment or increased clinical surveillance. Use during pregnancy or breastfeeding is generally restricted or recommended only after a careful assessment of the risks versus potential benefits.

Contraindications and Precautions: Agram is contraindicated in patients with a known hypersensitivity to the active substance or any excipients. Precautions are advised for patients taking certain concomitant medications that are known to have significant drug-drug interactions with Agram, potentially leading to increased adverse event risk or loss of efficacy.

The regulatory safety structure focuses on clear communication of the established risk profile, detailing which side effects are most expected and which represent serious but uncommon events, thereby providing a formal framework for understanding the drug's safety boundaries.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documents define an overdose of the active ingredient, Sildenafil, as a state characterized by an increase in the frequency and severity of documented adverse reactions.

Overdose manifestations may include intensified headache, flushing, dyspepsia, dizziness, and physiological signs such as marked decreased blood pressure (hypotension). Exposure-related factors, such as severe hepatic or renal impairment, may functionally increase the risk of these effects due to reduced clearance.


Documented Emergency Actions

The most critical emergency condition documented in the labeling is a prolonged erection lasting longer than four hours; the instruction is to seek immediate medical assistance for this specific event.

  • For accidental overdose or the sudden onset of severe vision loss or hearing loss, regulatory guidance directs that the medication be stopped, and a doctor be called immediately.

Supportive Management

Management of an overdose is defined as symptomatic and supportive because no specific antidote is known for Sildenafil. Official information also specifies a constraint on treatment, noting that renal dialysis is not expected to accelerate the clearance of the drug due to its extensive plasma protein binding.

Therapeutic Uses of Agram

Agram is generally used across two therapeutic domains. The medication is commonly applied in addressing conditions that present with systemic or localized discomfort, specifically Erectile Dysfunction (ED) and Pulmonary Arterial Hypertension (PAH).


Supportive Relief and Indications

For men experiencing Erectile Dysfunction, the therapeutic benefit is support in addressing impaired erectile function, which may help improve sexual satisfaction and contributes to easing the functional strain. In the chronic management of Pulmonary Arterial Hypertension, a condition where high blood pressure affects the arteries of the lungs, Agram supports maintenance of exercise tolerance and may assist in easing breathing difficulties associated with physical activity.

“The medication is considered relevant for easing symptomatic burden across domains where supportive symptom management is appropriate.”

It is relevant for managing symptom clusters that create noticeable functional strain, such as the difficulty in achieving or maintaining an erection and functional limitations associated with high blood pressure in the lungs.


Quick Fact: Relief for Functional Strain Agram supports patients during episodes of heightened systemic burden and helps maintain a sense of stability when symptoms are more noticeable, assisting with maintaining functional stability in daily life.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Agram?

This section defines population eligibility for Agram (Sildenafil) based strictly on official regulatory labeling.


Contraindicated Populations

Use is strictly prohibited (contraindicated) for individuals using any form of organic nitrates or nitric oxide donors (e.g., nitroglycerin). It is also contraindicated in patients with a history of Non-arteritic Anterior Ischaemic Optic Neuropathy (NAION), known hypersensitivity to Sildenafil, recent stroke or myocardial infarction, unstable angina, or severe hypotension.


Age- and Condition-Based Restrictions

Population Group Regulatory Status
Adults (18+ years) Approved population for both ED and PAH indications.
Pediatric Patients Contraindicated for Pulmonary Arterial Hypertension (PAH); Not Indicated for Erectile Dysfunction (ED).
Severe Hepatic Impairment Use is Not Recommended (Child-Pugh Class C).
Severe Renal Impairment Requires Special Caution and may necessitate dosage adjustment.
Pregnancy/Lactation Not Recommended for the PAH indication due to insufficient data.

Agram is explicitly not indicated for the ED indication in women or children. The profile is defined by absolute prohibitions and specific restrictions based on pre-existing conditions and organ function.

What should I know about interactions with other medicines?

Agram's interaction profile centers on two primary mechanisms: cardiovascular effects and an increased risk of bleeding. The drug is a phosphodiesterase 3 (PDE3) inhibitor, which is known to increase both the heart rate and the QTc interval on an electrocardiogram.

Cardiovascular Interactions

The use of Agram is not recommended in patients with pre-existing risk factors for QTc interval prolongation, such as congenital long QT syndrome or a known history of acquired QTc prolongation. This restriction extends to the concurrent use of medicinal products that can prolong the QTc interval. Patients with heart failure, bradyarrhythmias, or uncorrected electrolyte abnormalities should be monitored periodically with an electrocardiogram.

Bleeding Risk Interactions

There is an increased risk of hemorrhagic events when Agram is used at the same time as Aspirin or other medicinal products known to increase bleeding risk. Due to this potential for enhanced bleeding, the risks and benefits of co-administration with Aspirin must be carefully assessed on an individual basis before combination therapy is considered. Other PDE3 inhibitors may also exacerbate Agram’s inotropic (heart-strengthening) effects, requiring careful consideration if combining these classes of medications.

Mechanism of Action

Molecular Mechanism: Inhibition of the PDE5 Enzyme

Sildenafil operates by binding to and acting as a competitive inhibitor of the enzyme Phosphodiesterase type 5 (PDE5). This molecular interaction occurs at the enzyme's active site, blocking PDE5's primary function: the hydrolysis (breakdown) of the cellular signaling molecule, cyclic Guanosine Monophosphate (cGMP). By protecting cGMP from being deactivated, the drug maintains the stability and duration of this key intracellular messenger.


Pathway Modulation: Amplification of the NO-cGMP Cascade

Sildenafil modulates the Nitric Oxide (NO) / cGMP signaling cascade, a key physiological pathway governing vascular tone. The mechanism operates downstream from the initial trigger, acting as an amplifier of the endogenous signal. This sustained presence of higher cGMP levels leads to the prolonged activation of downstream effector proteins, such as Protein Kinase G (PKG). This crucial biochemical step results in vascular smooth muscle relaxation.


Systemic Consequence: Localized Vasodilation

PKG activation triggers events that cause the relaxation of vascular smooth muscle tissue, leading to vasodilation (the widening of blood vessels). This relaxation reduces local vascular resistance, resulting in increased localized blood flow within the target tissue. The entire mechanistic sequence is contingent upon the pre-existing release of Nitric Oxide from local nerve and endothelial cells.

Dosage and Administration Information

Administration and Dosing Principles

The official use of Sildenafil is structured by two distinct administration patterns, differentiated by the intended application: intermittent use for Erectile Dysfunction (ED) and scheduled, long-term maintenance therapy for Pulmonary Arterial Hypertension (PAH).


Approved Forms and Routes

Sildenafil is available as an oral tablet for both indications and as an oral suspension or intravenous (IV) injection specifically for PAH. The IV route is reserved only for patients who are temporarily unable to tolerate oral administration.


Standardized Usage Patterns

Usage Aspect Erectile Dysfunction (ED) Pattern Pulmonary Arterial Hypertension (PAH) Pattern
Frequency As needed; maximum of once per day. Scheduled, administered three times a day (TID).
Dosing Range Starting dose is 50 mg, adjustable between 25 mg and a maximum single dose of 100 mg. Recommended dose is 20 mg TID, with titration up to 80 mg TID. IV dose is 10 mg TID.
Intake Condition Can be taken with or without food, though a high-fat meal may delay activity onset. Can be taken with or without food.

Population-Specific Considerations

Official labeling indicates that a lower starting oral dose of 25 mg should be considered for the ED indication in older adults (aged 65 years and over) and in patients who present with severe kidney or liver impairment. Additionally, when Sildenafil is co-administered with a strong CYP3A4 inhibitor such as ritonavir, the maximum dose for ED must be restricted to 25 mg over a 48-hour period. For the oral suspension form, preparation requires reconstitution with water and subsequent shaking prior to each dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Agram (Sildenafil)

Evidence for use in Erectile Dysfunction (ED)

The research base for Sildenafil's evaluation in conditions characterized by functional limitations, specifically Erectile Dysfunction (ED), has relied heavily on numerous short-term, placebo-controlled Randomized Controlled Trials (RCTs). Researchers monitored patient-reported outcomes describing perceived discomfort and physiological strain using questionnaires, such as the International Index of Erectile Function (IIEF). The populations studied included adult males with ED arising from various root causes. Studies reported measurements of patient self-reported functional outcomes and changes in IIEF scores compared to placebo control groups. Findings from this research describe how patient-reported functional status evolved in the observed populations during the study period.

Evidence for use in Pulmonary Arterial Hypertension (PAH)

For Pulmonary Arterial Hypertension (PAH), research examined Sildenafil in pivotal, short-term RCTs, supplemented by long-term open-label extension studies. A central focus of these studies was to monitor outcomes related to physical discomfort and activity level, primarily by measuring the 6-Minute Walk Distance (6MWD), as well as tracking changes in the patient's WHO Functional Class and time to clinical worsening. Studies conducted during periods of increased symptom activity reported measurable differences in 6MWD scores compared to patients receiving placebo. Data collected through extended follow-up studies described the patterns of long-term use and the observed changes in functional capacity and survival over periods of up to several years.

What is Still Uncertain About Agram's Research Record

One of the main research limitations is that the follow-up durations were limited in many initial RCTs, meaning long-term effects are not fully established across both indications. For PAH, there is limited information regarding long-term survival patterns derived from the initial short-term studies. Data for certain groups, particularly specific rare causes of PAH or very specific subgroups of ED, remain insufficient. Regulatory bodies have highlighted that findings were mixed regarding optimal dosing and potential risks in the pediatric population for PAH, indicating that certainty remains low in these specific areas.

Frequently Asked Questions (FAQ)

Common questions about Agram (FAQ)

Q: Does Agram treat the underlying condition or just the symptoms?

A: Agram operates by targeting and amplifying a natural process that relaxes the smooth muscle in blood vessels, which works to improve blood flow. Regulatory documents describe this action as a way to manage the symptoms associated with the conditions it is approved to treat, rather than offering a cure for the underlying diseases.

Q: How long does it typically take to notice the effects of Agram?

A: Official dosing information states that for the Erectile Dysfunction (ED) indication, the drug is typically taken about one hour before sexual activity. The time it takes to notice the effects is described as potentially occurring anywhere from 30 minutes up to four hours after administration for the ED indication.

Q: If I miss a dose of Agram, what is generally described as the process?

A: For the Pulmonary Arterial Hypertension (PAH) indication, which is taken on a scheduled basis, official patient instructions advise taking the missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, official instructions describe skipping the missed dose and resuming the regular schedule. Regulatory guidance indicates that a double dose should not be taken to compensate for a missed one.

Q: Can Agram be crushed or chewed?

A: Official information indicates that the tablets are generally intended to be swallowed whole with water. Crushing or chewing the tablets is not typically recommended, as this may affect the drug's properties, unless a specific formulation (like an oral suspension or orally disintegrating tablet) is prescribed.

Q: Is Agram considered a first-line treatment option?

A: Official sources note that Agram is used in the management and treatment of the conditions for which it is approved. It is recognized as the first medicine of its class, a PDE5 inhibitor, to be approved for Erectile Dysfunction (ED), establishing its role in the treatment landscape.

Q: Can Agram be taken indefinitely, or is it intended for short-term use?

A: Research has examined the patterns of long-term use over periods of up to several years for the treatment of both conditions. This data describes the observed use patterns in study populations.

Q: What are the most commonly reported side effects of Agram?

A: Adverse reactions that are commonly reported in official documents often include headache, flushing, dizziness, nasal congestion, upset stomach, and abnormal vision. These are generally seen in a noticeable percentage of patients in clinical trials.

Q: Are there any serious side effects associated with Agram described in official documents?

A: Yes, official documentation describes certain serious and clinically significant adverse reactions. These include severe low blood pressure (hypotension), sudden loss of vision or hearing, and Priapism, which is an erection lasting longer than four hours.

Q: Does Agram cause weight gain or weight loss?

A: According to official adverse reaction lists, increased weight and fluid retention are described as Common side effects in some clinical trial documentation. The effect is typically seen in 1% to 10% of patients.

Q: Is it common to feel drowsy or dizzy after taking Agram?

A: Official adverse reaction lists show that dizziness is described as a Common side effect. Insomnia, which is difficulty sleeping, is also listed as an adverse event. Patients should be cautious of these effects.

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

A: Regulatory warnings state that caution is necessary. Due to reported adverse events such as dizziness and visual changes, the drug’s label describes that a patient’s awareness of the effects is important before engaging in activities like driving or operating machinery.

Q: Are there specific foods or beverages that interact with Agram?

A: Official drug information notes that taking the medicine with a high-fat meal may delay how quickly the drug is absorbed and begins to work. Official documents describe that the use of grapefruit products may increase the drug's level in the body, which is a pharmacokinetic interaction.

Q: Is it safe to consume alcohol while using Agram?

A: Official patient information indicates that alcohol may increase the drug's blood pressure lowering effect. This combination may raise the risk of experiencing symptoms such as dizziness and fainting.

Q: Does Agram interact with common over-the-counter pain relievers?

A: Official drug interaction warnings state that an increased risk of bleeding is described when the drug is used at the same time as Aspirin. No common interaction is typically found with Acetaminophen (Tylenol).

Q: Are there any herbal supplements or vitamins known to interact with Agram?

A: Official warnings mention that specific herbal supplements, such as St. John's Wort, may interact by lowering the drug's levels in the body. General caution is noted in official materials because herbal remedies are often not tested by regulators in the same way as prescription medicines.

Q: Can Agram be used by elderly patients?

A: The drug is approved for use in the general adult population. For the Erectile Dysfunction (ED) indication, official guidelines indicate that a lower starting dose may be considered for older adults aged 65 years and over.

Q: Do studies suggest Agram is less effective over time?

A: Research on the long-term use of the drug for the ED indication has generally argued against a loss of effectiveness. This evidence suggests that drug tolerance is not typically developed over periods of several years.

Q: Why do some people report feeling no effect from Agram?

A: The mechanism of Agram is described as dependent on the prior release of Nitric Oxide from local cells. This means that for the ED indication, the drug's action is contingent upon the presence of sexual stimulation to be effective.

Q: What is the purpose of the different markings or colors on the Agram tablet?

A: Official documents note that the distinctive color and shape of the original tablet are typically associated with the brand-name product. The color, shape, and markings of generic versions may vary based on the manufacturer.

Q: Does Agram have to be taken at a specific time of day?

A: For the Erectile Dysfunction (ED) indication, the drug is used only as needed before activity. For the Pulmonary Arterial Hypertension (PAH) indication, it is taken on a scheduled basis, typically three times a day at approximately equal intervals, but no specific time of day is mandated.

Q: Does Agram require special monitoring or blood tests?

A: Monitoring is documented for specific high-risk groups. For instance, periodic ECG monitoring is recommended for patients with pre-existing risk factors for QTc prolongation. Dose adjustments may also be needed based on liver enzyme elevations.

Q: Is Agram a type of antibiotic?

A: No, Agram is not an antibiotic. Official regulatory bodies classify the drug as a Phosphodiesterase type 5 (PDE5) inhibitor, a class of medication known for its effects on blood vessel relaxation and blood flow.

Q: Why does Agram have a warning about certain pre-existing conditions?

A: Warnings are in place because the drug has vasodilatory properties, meaning it relaxes and widens blood vessels. This effect may adversely affect patients who have certain underlying heart or vascular conditions, such as severe low blood pressure or a recent stroke.

Q: What happens if I stop taking Agram suddenly?

A: For the scheduled Pulmonary Arterial Hypertension (PAH) indication, official documents advise that treatment is usually long-term. Official documents describe that abruptly stopping the medication for the PAH indication can lead to complications, and a gradual dose reduction is a procedure sometimes described.

Q: Is Agram known to cause mood changes or depression?

A: Official adverse reaction lists show that Insomnia (difficulty sleeping) and Anxiety are listed as Common adverse reactions. Depression has also been described in post-marketing reports, although at a lower, non-quantified frequency.

Q: Is Agram available as a generic medicine?

A: Yes, Agram is available in its generic form. The active ingredient is called Sildenafil, and the generic versions are officially listed as Sildenafil tablets.

Q: What is the difference between the brand name and generic version of Agram?

A: The generic version contains the same active ingredient, Sildenafil, and is required to demonstrate equivalent therapeutic effects. However, the tablets may differ from the brand name in appearance, such as their color, shape, and inactive ingredients.

Q: Do patients typically need to take Agram for a long period?

A: For the Pulmonary Arterial Hypertension (PAH) indication, treatment often involves long-term use, with studies tracking patients over several years. For the Erectile Dysfunction (ED) indication, the drug is used only on an as-needed basis, based on the dosing schedule.

Q: Is Agram habit-forming or addictive?

A: Official documents describe the drug as not being a controlled substance. It is not generally described in authoritative documents as being habit-forming or a substance of abuse.

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

A: Signs of a severe allergic reaction (hypersensitivity) described in regulatory documents include a rash, hives, or swelling of the face, lips, tongue, or throat. These reactions may also involve difficulty breathing.

Q: Are there any lifestyle changes recommended alongside taking Agram?

A: Official patient counseling information details the effects of certain lifestyle factors on the drug. For example, high-fat meals may delay the onset of effect, and alcohol may increase the drug's blood pressure lowering properties.

Q: Does Agram affect sleep patterns?

A: Yes, official adverse reaction lists state that Insomnia, which is difficulty sleeping, is an adverse reaction that was reported in clinical trials.

Q: Is Agram used for pain relief?

A: The approved therapeutic uses for Agram are specifically for Erectile Dysfunction (ED) and Pulmonary Arterial Hypertension (PAH). The drug is not generally classified by regulatory bodies as a medication for pain relief.

How should Agram be stored and disposed of?

How to Store and Dispose of Agram?

The official storage and disposal guidelines for Agram (Sildenafil) are set by regulatory authorities to maintain product integrity and ensure safe discard practices.


Official Storage Requirements

Requirement Specific Instruction
Temperature Store the tablets strictly below 30^circC (86^circF).
Container Keep medication in the original container, which must be tightly closed.
Stability Do not use the medication past the printed expiry date.
Handling Do not freeze the tablets.
Safety Must be stored out of the sight and reach of children.

Official Disposal Instructions

To dispose of unused or expired Agram, regulatory instructions advise using a community drug take-back program. If a program is unavailable, mix the tablets with an undesirable substance, such as used coffee grounds, and seal the mixture in a container before placing it in the household trash. Do not flush Agram down the toilet or pour it down a drain.

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

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