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Sildenafil Pfizer

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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.

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Overview of Sildenafil Pfizer

Property Description
Active ingredient Sildenafil citrate
Form Film-coated tablets
Pharmacological class Selective Phosphodiesterase type 5 (PDE5) inhibitor
General purpose Supports enhanced localized blood flow
Origin Synthetic compound

Sildenafil Pfizer: Chemical Identity and Class of Medicine

Sildenafil Pfizer is a prescription-only synthetic medicine supplied as film-coated oral tablets, containing the active substance Sildenafil citrate. While Sildenafil is the active International Nonproprietary Name (INN), this product is associated with the global pharmaceutical company Pfizer, underscoring its specific manufacturing origin and quality control standards. Sildenafil belongs to the high-level pharmacological category known as Selective Phosphodiesterase type 5 (PDE5) inhibitors, a classification consistent with its precise chemical structure as a pyrazolopyrimidinone derivative. The active ingredient is a synthetic compound manufactured in a laboratory setting, and it is presented as a single-ingredient product, differing from combination therapies. This identity and classification are clinically recognized and supported by pharmacological data.

How the PDE5 Inhibitor Mechanism Relates to General Purpose

The general therapeutic purpose of Sildenafil is to support conditions requiring enhanced localized blood flow by inducing vasodilation. As a Selective PDE5 inhibitor, the drug functions by blocking the action of the PDE5 enzyme, which naturally degrades a key cellular signaling molecule called cyclic guanosine monophosphate (cGMP). By protecting and sustaining cGMP levels, Sildenafil amplifies the natural relaxation signal within the smooth muscle of blood vessel walls. This targeted action increases the vessel's capacity for blood circulation in specific body tissues, which is the foundational mechanism for the drug's overall medical utility. This pharmacological function provides the basis for managing conditions where restricted blood flow is the primary concern, a therapeutic benefit consistently defined in regulatory documentation.

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What side effects are possible with Sildenafil Pfizer?

Possible Side Effects and Safety Information

The safety profile of sildenafil is formally classified by regulatory authorities based on the frequency and system-organ class of documented adverse reactions. These classifications are derived from clinical trials and post-marketing surveillance data.

Frequency Classification of Adverse Reactions

Side effects are categorized by incidence, with headache being the most frequently reported adverse reaction, classified as Very Common (affecting more than 1 in 10 users). Effects classified as Common (affecting up to 1 in 10 users) generally involve the vascular, gastrointestinal, and sensory systems, including flushing, dyspepsia, dizziness, and specific forms of abnormal vision (such as a color tinge or blurred vision).

Less frequently reported, or Uncommon, reactions (affecting up to 1 in 100 users) may include cardiovascular effects such as tachycardia or hypotension, as well as nausea and skin rash.

Serious Adverse Reactions and Safety Constraints

Official regulatory documents note a number of adverse reactions that are considered serious, often based on post-marketing reports. These include Priapism (a prolonged erection lasting over four hours), cases of sudden decrease or loss of vision (specifically Non-arteritic Anterior Ischemic Optic Neuropathy or NAION), and sudden decrease or loss of hearing.

Specific regulatory constraints exist regarding the use of sildenafil. It is contraindicated for use in patients taking any form of organic nitrates or nitric oxide donors due to the high risk of severe, life-threatening hypotension. Furthermore, caution is advised for patients with pre-existing conditions that predispose them to Priapism or for those with severe hepatic or renal impairment.

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Overdose and Emergency Response

Overdose and when to seek help

The information in this section is derived strictly from official government regulatory documents (e.g., FDA and EMA labeling) concerning overdose manifestations and mandated emergency actions.

Documented Overdose Presentations

Official regulatory sources document that when Sildenafil is taken in excessive doses, such as those up to 800 mg in clinical trials, the resulting clinical manifestations are an increase in the rate and severity of adverse effects already known at therapeutic doses. These documented presentations include headache, flushing, dizziness, and visual disturbances.

Required Emergency Actions

Immediate medical attention is required under two specific scenarios defined in the regulatory labeling:

  • Suspected Overdose: If an overdose is confirmed or strongly suspected, the patient must call a doctor or go to the nearest hospital emergency room right away.
  • Prolonged Erection: If an erection persists for longer than 4 hours, the patient must seek immediate medical assistance. Regulatory documents emphasize this action is crucial to prevent potential penile tissue damage and permanent loss of potency.

Management and Antidote Status

Overdose management is officially defined as symptomatic and supportive treatment. No specific antidote for Sildenafil overdose is known or documented in the official prescribing information. Furthermore, due to the drug's high plasma protein binding, regulatory data indicates that renal dialysis is not expected to accelerate clearance from the body.

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Therapeutic Uses of Sildenafil Pfizer

Quick Facts: Sildenafil's Therapeutic Applications

  • Addresses: Erectile dysfunction (ED) in adult men.
  • Manages: Pulmonary arterial hypertension (PAH).
  • Supports: The ability to attain and maintain an erection during sexual stimulation.
  • Promotes: Improved exercise capacity for certain patients with PAH.

Sildenafil is a medication prescribed to address two distinct medical conditions. For adult men, it is indicated for the management of erectile dysfunction (ED), a condition where there is difficulty in achieving or keeping an erection suitable for sexual relations. When used for this application, the treatment aims to support the capacity for a satisfactory erection in response to sexual arousal.

Sildenafil also has an established role in the treatment of Pulmonary Arterial Hypertension (PAH), a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. For individuals with PAH, sildenafil's use is to help improve their capacity for exercise and to assist in delaying clinical worsening of the condition.

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Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Sildenafil Pfizer

Official regulatory documents define strict criteria for Sildenafil eligibility, based on age, sex, organ function, and pre-existing medical conditions.


Eligibility Classification Status & Population (as stated in label)
Populations Allowed Adult men (18+) for ED; Adults (18+) for PAH.
Contraindicated Patients using nitrates or guanylate cyclase stimulators (e.g., riociguat).
Contraindicated History of Non-Arteritic Anterior Ischaemic Optic Neuropathy (NAION) in one eye.
Contraindicated Severe hepatic impairment, hypotension (BP <90/50 mmHg), recent stroke, or myocardial infarction.
Age Restriction Not indicated for individuals under 18 years of age (ED indication). Chronic use is not recommended in children (PAH indication).
Sex/Repro Status Not indicated for use in women (ED indication). Not recommended during pregnancy or lactation.
Use with Caution Patients with severe renal impairment or hepatic impairment (require consideration of a reduced starting dose).

The regulatory profile prohibits use in individuals with certain severe cardiovascular issues, particularly where sexual activity is inadvisable, and in those with known hereditary degenerative retinal disorders. Caution is also advised for patients with anatomical penile deformities or conditions predisposing to priapism.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Sildenafil’s interaction profile is documented in regulatory sources based on its potential for additive vasodilatory effects and its primary metabolic pathway (CYP3A4).

Formally Contraindicated Combinations

Co-administration is officially prohibited with:

  • Organic Nitrates (e.g., nitroglycerin, isosorbide dinitrate) or Nitric Oxide Donors (including recreational alkyl nitrites) due to the risk of severe, potentially fatal hypotension from pharmacodynamic synergism.
  • Guanylate Cyclase (sGC) Stimulators (e.g., Riociguat), which also cause additive blood pressure lowering and are formally contraindicated.

Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance Category Regulatory Description
Strong CYP3A4 Inhibitors (e.g., Ritonavir, Saquinavir) Reduce Sildenafil clearance, leading to significantly increased plasma concentrations (e.g., 11-fold increase in AUC with Ritonavir) [Source: FDA Accessdata].
Alpha-blockers May cause symptomatic hypotension due to additive blood pressure lowering effects [Source: EMA Product Information].
CYP3A4 Inducers (e.g., Bosentan) Increase Sildenafil clearance, which can reduce exposure [Source: NIH DailyMed].

Administration Constraints and Product Interactions

Specific constraints are mandated when Sildenafil is co-administered with strong inhibitors: the maximum recommended single dose must not exceed 25 mg within a 48-hour period for patients taking Ritonavir. Furthermore, the official label notes that co-ingestion with a high-fat meal may delay the time to reach peak plasma concentration. Consumption of grapefruit juice can also increase Sildenafil plasma levels by inhibiting CYP3A4 metabolism in the gut wall [Source: FDA/EMA official labels].

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Mechanism of Action

Selective Inhibition of the PDE5 Enzyme

Sildenafil's primary action is the selective competitive inhibition of the enzyme Phosphodiesterase type 5 ( PDE5). This molecular interaction prevents PDE5 from degrading the cellular messenger cyclic Guanosine Monophosphate ( cGMP). By blocking this enzyme, the drug preserves and contributes to elevated cGMP concentration within the smooth muscle cells.


Context-Dependent Pathway Potentiation

The mechanism is functionally dependent on the prior release of Nitric Oxide ( NO) from the body, which naturally initiates the cGMP cascade. Sildenafil acts only as a potentiator, sustaining the signal once it has been naturally triggered, rather than initiating the process itself. This selectivity means the drug's action is context-dependent.


Modulation of Vascular Smooth Muscle Tone

The elevated intracellular cGMP activates a cascade that leads to the relaxation of vascular smooth muscle fibers, primarily by modulating calcium ion concentration. This physiological change results in vasodilation (vessel widening) in the target tissues, which is the systemic consequence leading to altered localized blood flow dynamics.

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Dosage and Administration Information

How to Use Sildenafil Pfizer

Sildenafil use is dictated by the specific condition being managed, establishing distinct administration methods and schedules as established for this substance.


Administration Scope

The medicine is typically administered via the oral route as a film-coated tablet for both indications, but an intravenous (IV) form is also approved for Pulmonary Arterial Hypertension (PAH) when oral use is not feasible. The IV dose is 10 mg and must be administered as a bolus injection over a period of at least 10 seconds, without mixing with other medications.

Indication Dose Range Frequency and Timing
Erectile Dysfunction (ED) 25 mg to 100 mg As needed, maximum once daily; taken 30 minutes to 4 hours before activity.
Pulmonary Arterial Hypertension (PAH) 20 mg (Oral) Three times daily (TID), at approximately 4 to 6-hour intervals.

Context and Population Adjustments

For the ED indication, taking the tablet with a high-fat meal may lead to a delay in the onset of effect, whereas the PAH dose can be taken with or without food. Standard clinical guidelines specify that lower starting doses of 25 mg are to be considered for the ED indication in older adults (over 65 years), as well as in patients with severe renal or hepatic impairment. The use of Sildenafil for ED is characterized as intermittent, while its use for PAH is established as chronic.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Sildenafil Pfizer


Research Evidence for Erectile Dysfunction (ED)

The research exploring Sildenafil for erectile dysfunction (ED) was evaluated in short-term, randomized, double-blind, placebo-controlled trials (RCTs). These trial designs are used in research to compare the effects of the active substance against an inactive substance (placebo). This type of research was supplemented by reviews that combined the results of multiple studies and by long-term open-label extension studies.

Research examined these conditions, which are characterized by fluctuating or episodic manifestations, and was evaluated in settings with varying symptom burdens. Studies explored outcomes reflecting daily functioning or activity level, specifically the patient-reported outcomes describing their perceived discomfort related to ED. These trials included a variety of adult men, including those with ED related to underlying conditions such as diabetes mellitus and hypertension.

The findings describe patterns observed in the studies related to changes in patient-reported functional scores when comparing those who received the study drug versus those who received placebo over the short term. Research so far indicates that the data show patterns related to changes measured during the study period in patient-reported outcomes linked to the ability to attain and maintain an erection.


Research Evidence for Pulmonary Arterial Hypertension (PAH)

For Pulmonary Arterial Hypertension (PAH), the evidence also begins with randomized, double-blind, placebo-controlled trials. This research was conducted to evaluate the substance's effect on systemic or functional imbalance. The main functional measure monitored was the 6-Minute Walk Distance (6MWD), which monitors outcomes reflecting daily functioning or activity level, as a measure of functional capacity. Additionally, studies monitored the time to a clinical worsening event, which is a combined outcome reflecting negative changes. The studies included adults with various forms of PAH.


Long-Term Studies and Durability of Effect

Understanding the effects of Sildenafil over extended periods relies on data gathered from long-term open-label extension studies. For ED, studies report how symptoms evolved in the observed populations over time intervals extending up to four years, and this research contributes to the broader evidence landscape regarding long-term use.


Evidence in Specific Patient Populations

For PAH, studies explored the use of Sildenafil in pediatric patients (children aged 1 to 17 years). Subsequent long-term research focusing on this population has described patterns observed in the studies that was associated with an unexpected signal of increased mortality when higher doses were used. This finding was associated with differences in regulatory guidance concerning pediatric use in certain regions, and research is ongoing.


Evidence Quality and Remaining Uncertainties

A body of evidence exists for Sildenafil, primarily through short-term, controlled trials for both approved uses. The quality of this research is classified as High for initial functional measures studied in adults. However, research provides context but not individual predictions, and long-term effects are not fully established based on the highest level of evidence. Results apply only to the populations studied, and data for certain groups remain insufficient.

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Frequently Asked Questions (FAQ)

Common questions about Sildenafil Pfizer (FAQ)

Q: What is the main difference between Sildenafil and Sildenafil Pfizer?

A: Sildenafil is the name of the active pharmaceutical ingredient, or sildenafil citrate. Sildenafil Pfizer is the specific branded product associated with the manufacturing origin and quality control standards of the Pfizer company. This information is consistent with official regulatory classification.

Q: Is Sildenafil Pfizer the same as generic sildenafil?

A: Sildenafil Pfizer contains the active ingredient sildenafil citrate, which is the same chemical compound found in generic sildenafil products. The 'Pfizer' name indicates the specific manufacturer's brand, distinguishing it from generic versions which share the same active ingredient.

Q: Can Sildenafil Pfizer be taken with food, or does that change how it works?

A: Regulatory documents describe different guidelines based on the condition being treated. If the tablet is taken for the erectile dysfunction (ED) indication with a high-fat meal, this may lead to a delay in the onset of effect. Conversely, the dose for pulmonary arterial hypertension (PAH) can be taken with or without food.

Q: Does alcohol consumption significantly impact Sildenafil Pfizer's effects or safety?

A: Official documents describe that caution is typically associated with alcohol consumption while using this medicine. This is because alcohol intake may increase the risk of experiencing certain side effects, such as dizziness and lightheadedness.

Q: Does Sildenafil Pfizer have any known interactions with herbal supplements?

A: Sildenafil is processed in the body by an enzyme called CYP3A4. Regulatory information indicates that co-administration with substances that inhibit this enzyme, which can include certain herbal supplements, may alter the concentration of the drug in the body.

Q: Can people with liver or kidney issues use Sildenafil Pfizer?

A: Regulatory information indicates that Sildenafil is contraindicated (should not be used) in patients diagnosed with severe hepatic impairment (severe liver problems). Official prescribing information notes that a reduced starting dose for the ED indication is considered for individuals with severe renal (kidney) or hepatic impairment.

Q: What is the general classification of Sildenafil Pfizer in terms of safety (e.g., Schedule 4)?

A: Sildenafil Pfizer is classified in official documents as a prescription-only synthetic medicine. This means that it is not available for purchase over the counter and requires authorization from a healthcare professional.

Q: Are there any warnings about combining Sildenafil Pfizer with recreational drugs in regulatory sources?

A: Official regulatory warnings specifically prohibit co-administration of this medicine with any nitrate-containing recreational drugs, such as alkyl nitrites (often referred to as 'poppers'). This is due to a high risk of severe and potentially fatal hypotension (dangerously low blood pressure).

Q: How quickly does Sildenafil Pfizer start to work after taking it?

A: According to the official product information for the erectile dysfunction indication, the medicine usually begins to work within 30 minutes after it is taken. It may be taken in a window of 30 minutes to 4 hours before activity.

Q: What happens if a dose of Sildenafil Pfizer is missed?

A: This guidance applies to the chronic treatment of Pulmonary Arterial Hypertension (PAH), which is taken on a fixed schedule. Official instructions concerning the PAH dose typically describe resuming the standard three times daily schedule at the time of the next regularly scheduled dose.

Q: Are there any specific foods or drinks to avoid while using Sildenafil Pfizer?

A: Official documents highlight a few specific interactions. Consumption of grapefruit juice is noted because it can increase the concentration of the medicine in the body. Additionally, co-ingestion with a high-fat meal may delay the time required for the drug to reach its peak concentration.

Q: Is there a maximum number of times Sildenafil Pfizer can be used per week?

A: For the erectile dysfunction indication, the maximum recommended dosing frequency stated in official instructions is once per day. This sets the limit on its intermittent use over a week.

Q: If I stop using Sildenafil Pfizer, will the original condition worsen?

A: Official documentation for the Pulmonary Arterial Hypertension (PAH) indication describes the medicine as helping to improve exercise ability and delay clinical worsening. For the ED indication, use is intermittent and is not associated with information provided on the condition worsening after cessation.

Q: Is it possible to feel dizzy or lightheaded after taking Sildenafil Pfizer?

A: Yes, regulatory documents list certain side effects. Dizziness is classified as a Common side effect. Furthermore, some official sources also include a light-headed feeling as a potential side effect, often related to the medicine's effect on blood pressure.

Q: How does Sildenafil Pfizer relate to treatments for pulmonary arterial hypertension (PAH)?

A: Sildenafil is indicated for the treatment of Pulmonary Arterial Hypertension (PAH). It is classified as a PDE5 inhibitor that works by relaxing blood vessels in the lungs to reduce blood pressure in that specific area. Research indicates it is used for the purpose of improving exercise ability and delaying clinical worsening.

Q: Can the effects of Sildenafil Pfizer be modified by psychological factors?

A: The mechanism of action for the erectile dysfunction indication is described as context-dependent. It relies on the prior, natural release of Nitric Oxide ( NO), which is initiated during sexual stimulation. The drug's function is to sustain this natural signal.

Q: Is Sildenafil Pfizer described as a hormone or related to testosterone in official literature?

A: No, official documents classify Sildenafil as a Selective Phosphodiesterase type 5 ( PDE5) inhibitor. It is a synthetic chemical compound that acts on an enzyme and is not described as a hormone or related to testosterone in the mechanism of action.

Q: What are the signs that Sildenafil Pfizer might be working as described?

A: For the ED indication, research evidence reports on changes in patient-reported ability to attain and maintain an erection following sexual stimulation. For the PAH indication, evidence reports on functional outcomes like the 6-Minute Walk Test.

Q: What are the rare but serious side effects associated with Sildenafil Pfizer?

A: Serious Adverse Reactions noted in official documents include Priapism (an erection lasting over four hours), sudden decrease or loss of vision (NAION), and sudden decrease or loss of hearing.

Q: Is there an official patient information leaflet available for Sildenafil Pfizer?

A: Yes, official regulatory bodies mandate that comprehensive product information be made available to the public. For instance, the US FDA provides the full drug label via DailyMed, and the European EMA publishes the Summary of Product Characteristics (SmPC) and an associated patient leaflet.

Q: Why is Sildenafil Pfizer sometimes referred to by a different brand name in some regions?

A: The active ingredient, sildenafil, is marketed globally under various brand names, depending on the regulatory region and the specific condition being treated. For example, the drug may have one brand name for the ED indication and a different one for the Pulmonary Arterial Hypertension indication in certain markets.

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How should Sildenafil Pfizer be stored and disposed of?

Storage and Disposal Requirements for Sildenafil Tablets

Sildenafil film-coated tablets must be stored according to mandatory regulatory guidelines to ensure stability.


Required Storage Conditions

  • Temperature: Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F). Do not store above 30 C.
  • Protection: The medicine must be kept in the original package to protect it from moisture.
  • Child Safety: Sildenafil must be kept out of the sight and reach of children.

Disposal

Expired or unused Sildenafil must be disposed of safely. Patients are instructed not to throw away any medicines via wastewater or general household waste. Disposal must be completed in accordance with local regulations, often by using a medicine take-back program.

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

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