Revatio

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Revatio

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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 Revatio

Property Description
Active ingredient Sildenafil citrate
Forms Oral tablet, Oral suspension, Intravenous (IV) solution
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor, Vasodilator
Common purpose Managing high pressure in the pulmonary arteries
Origin Synthetic compound

What is Revatio and How is it Classified?

Revatio is a specific, synthetic medication available only by prescription, primarily known for its active ingredient, Sildenafil citrate. It is classified pharmacologically as a Phosphodiesterase type 5 (PDE5) inhibitor, placing it within a class of drugs that function as targeted vasodilators. Pharmacological studies support the compound's focused efficacy in the circulatory system. This compound has been approved for its general purpose of managing symptoms associated with severe hypertension in the arteries of the lungs. This distinct focus on pulmonary circulation, often differentiating it from other products containing Sildenafil, ensures that the treatment is aligned with patient populations needing specialized cardiac and pulmonary support.


Composition and Available Pharmaceutical Forms

The preparation known as Revatio is a single active ingredient product, containing only Sildenafil citrate as the therapeutic compound. This medicine is supplied in three distinct dosage form(s) to ensure adaptability across patient care settings: the standard oral tablet, an oral suspension for flexible dosing, and a sterile intravenous (IV) solution. The availability of these forms ensures that the administration route, whether oral or intravenous, can be tailored to the individual patient’s clinical status and ability to swallow, including use in pediatric patients. The oral tablet and suspension rely on solid or liquid excipients for stability and absorption, while the IV solution utilizes an aqueous base for direct delivery into the bloodstream, a critical differentiating factor for hospital use.


The Core Function: Mechanism Principle and General Benefit

The core function of the active ingredient Sildenafil is rooted in the principle of selective enzyme inhibition, which leads to pulmonary vasodilation. By preventing the breakdown action of the PDE5 enzyme, the drug stabilizes crucial signaling molecules required for the relaxation and subsequent widening of vascular smooth muscle within the lungs. This fundamental mechanism is clinically recognized for its ability to reduce the resistance and pressure within the pulmonary arteries. The overall outcome of this targeted action is a decrease in the heart's workload and an optimization of blood flow through the lungs, supporting the efficient circulation of oxygenated blood throughout the body, a benefit crucial in scenarios where pulmonary pressure is compromised.

Regulatory References

  1. PDE5 Inhibitors - StatPearls - NCBI Bookshelf
  2. Revatio - European Public Assessment Report (EPAR)

What side effects are possible with Revatio?

Possible Side Effects and Safety Information

The safety profile of Revatio (Sildenafil citrate) is defined by official government regulatory documents, categorizing adverse reactions by frequency and physiological system. This information is non-advisory and strictly descriptive of documented risks.

Frequency-Classified Adverse Reactions

The most frequent findings in clinical trials are classified as Very Common (ge 1/10), which include headache, flushing, dyspepsia (indigestion), diarrhoea, and pain in extremity (limb pain). Reactions classified as Common (ge 1/100 to <1/10) encompass events like epistaxis (nosebleeds), insomnia, various visual disturbances (e.g., blurred vision, photophobia), nasal congestion, and back pain. Adverse events reported from post-marketing surveillance are considered of Not Known frequency.

Serious Safety Considerations and Restrictions

Official labeling documents several serious adverse reactions. These include priapism (prolonged erection lasting more than four hours), sudden decrease or loss of hearing, and Non-arteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision. Due to a risk of potentially fatal hypotension, Revatio is absolutely contraindicated for use with organic nitrates or the medication riociguat.

Population-Specific Safety Notes

Regulatory authorities advise specific caution for certain populations. The FDA generally recommends against the chronic use of Revatio in most pediatric patients due to safety concerns observed in long-term trials. Use is also not recommended in patients with Pulmonary Veno-Occlusive Disease (PVOD), as it may worsen the condition. Furthermore, the safety of the drug is formally documented as unknown in patients with active peptic ulceration or bleeding disorders.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation for Revatio outlines specific clinical manifestations and mandated actions required in the event of over-exposure. Overdose presentations are documented to be similar to common adverse reactions, but with an increased incidence rate and severity. In studies involving single doses up to 800 mg, clinical manifestations included the escalation of symptoms such as headache, flushing, dyspepsia, and altered vision.

When Immediate Medical Help is Required

Regulators mandate that patients seek immediate medical attention for several acute, severe events. This includes any erection that persists longer than four hours (priapism), as this condition carries a risk of penile tissue damage and permanent loss of potency if not treated promptly. Immediate or prompt medical attention is also required for a sudden loss of vision or a sudden decrease or loss of hearing, which may be accompanied by dizziness or ringing in the ears.

Management and Specific Considerations

Overdose management procedures are limited to standard supportive and symptomatic measures. Official regulatory documentation specifies that no specific antidote is available for sildenafil over-exposure. Due to the drug’s high plasma protein binding, renal dialysis is not expected to accelerate its clearance.

A specific caution exists regarding the use of doses higher than recommended in paediatric patients with Pulmonary Arterial Hypertension (PAH), due to a documented increased risk of mortality.

Therapeutic Uses of Revatio

Revatio is a prescription medication approved for the treatment of pulmonary arterial hypertension (PAH), which is a condition involving high blood pressure in the arteries of the lungs.

Quick Facts: Revatio's Therapeutic Domain

  • Target Condition: Pulmonary Arterial Hypertension (PAH), specifically WHO Group I.
  • Primary Benefit (Adults): Intended to improve exercise ability and delay clinical worsening associated with the condition.
  • Paediatric Use: Available for the treatment of PAH in children and adolescents aged 1 year to 17 years.

For adults with pulmonary arterial hypertension, this agent is utilized to support the patient's capacity for physical activity and contribute to the overall stabilization of the disease course. The medication is utilized to support improvements in symptoms for patients classified as WHO functional class II and III. It is approved for use in both adults and for patients from 1 to 17 years old. The treatment aims to manage the effects of the condition. For specific information regarding its indications and conditions of use, a medical professional should be consulted.

Eligibility and Restrictions for Use

The eligibility profile for Revatio is defined by official regulatory documentation and establishes clear populations for whom use is prohibited or restricted.

Contraindicated Populations

Use is strictly contraindicated for patients who are currently taking organic nitrates or guanylate cyclase stimulators (such as riociguat) due to the risk of severe hypotension. Absolute non-eligibility also applies to patients with a history of vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION) or known hypersensitivity to sildenafil.

Age and Organ Function Limits

Revatio is approved for use in adults and pediatric patients ge 1 year of age. However, regulatory agencies note that chronic use is generally not recommended in children due to complex risk-benefit considerations related to long-term data. The medicine is also contraindicated in patients with severe hepatic impairment (Child-Pugh Class C). For patients with severe renal impairment, no initial dose adjustment is required.

Additional Restrictions

Use is not recommended for women who are pregnant or breastfeeding, or for patients with pulmonary veno-occlusive disease (PVOD). Caution is advised for individuals with conditions that predispose to priapism or those with recent serious cardiovascular events, such as a myocardial infarction or stroke.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Formal regulatory documentation outlines specific interaction patterns for Revatio (Sildenafil), primarily categorized by their impact on plasma exposure and circulatory function.

Contraindicated Combinations

Co-administration is formally contraindicated with any form of organic nitrates and with Guanylate Cyclase (GC) Stimulators (e.g., Riociguat). These prohibitions exist due to the documented risk of severe, additive hypotensive effects.

Pharmacokinetic and Exposure Modification

Sildenafil is predominantly cleared via the hepatic enzyme CYP3A4. Interactions with enzyme modulators cause significant exposure changes:

  • Potent CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole) officially increase Sildenafil plasma exposure ( AUC/ C max) and their co-administration is restricted or not recommended.
  • CYP3A4 Inducers (e.g., Bosentan, Rifampin) officially cause a decrease in Sildenafil plasma exposure.

Pharmacodynamic and Other Interactions

Alpha-blockers (e.g., Doxazosin) may contribute to symptomatic hypotension due to documented additive vasodilatory effects. The official labeling also notes a potential for increased bleeding risk (epistaxis) when co-administered with oral Vitamin K Antagonists in certain patient populations. Furthermore, Grapefruit Juice can raise Sildenafil plasma levels, and alcohol may intensify the drug's blood pressure-lowering effects.

Mechanism of Action

How Revatio Works

The action of Sildenafil (Revatio) is defined by its role as a selective molecular inhibitor that targets an enzyme involved in the regulation of vascular tone. The drug does not initiate the process of vessel relaxation but rather amplifies the body’s natural signal, which results in an alteration of pressure dynamics within the circulatory system.


Selective Inhibition of the PDE5 Enzyme

Sildenafil acts as a selective competitive inhibitor of the enzyme Phosphodiesterase type 5 (PDE5), which is concentrated within the walls of the pulmonary arteries. By binding to PDE5, the drug prevents the breakdown of the signaling molecule, cyclic Guanosine Monophosphate (cGMP).


Amplification of the Nitric Oxide–cGMP Pathway

The preservation of cGMP amplifies the relaxation message carried by the body's Nitric Oxide (NO) signal, triggering a cascade that relaxes the vascular smooth muscle cells. This molecular event culminates in vasodilation (widening) of the pulmonary vessels, which directly influences the flow dynamics and pressure within that system.


Modulation of Pulmonary Vascular Resistance

This relaxation of the arteries leads to a fundamental physiological consequence: the reduction of Pulmonary Vascular Resistance (PVR). A decrease in PVR alters the mechanical resistance encountered by blood flowing through the lungs, causing a subsequent reduction in Pulmonary Artery Pressure (PAP).

Dosage and Administration Information

Revatio is administered via the oral route using tablets or an oral suspension, or through a temporary intravenous (IV) route. This medication is prescribed for long-term, continuous therapy and is typically taken or administered three times a day (TID), with doses spaced approximately four to eight hours apart. The oral tablet and suspension forms can be taken with or without food.


Standard Dosing Regimens

Population Starting/Standard Dose Maximum Allowed Dose (TID)
Adults (Oral) 20 mg TID 80 mg TID
Adults (IV) 10 mg TID 10 mg TID

The recommended starting dose for adult oral use is 20 mg TID, though it may be adjusted up to 80 mg TID based on patient tolerability. The 10 mg IV dose is reserved as a temporary substitution for patients who cannot tolerate the oral form and is considered pharmacologically equivalent to the 20 mg oral dose.


Special Administration Principles

Clinical guidelines provide specific guidance for different populations. Pediatric dosing is weight-based, with children weighing over 20 kg typically starting on 20 mg TID. No initial dose adjustment is required for older adults (≥ 65 years) or patients with mild to moderate hepatic or renal impairment.

The oral suspension requires specific preparation: the powder must be reconstituted by adding a total of 90 mL of water in two steps, with vigorous shaking after each addition. If a scheduled dose is missed, patients should take it as soon as possible, but they must not take a double dose to compensate.

Recent Clinical Evidence

Research Evidence: Overview of Clinical Studies for Revatio

Evidence for Use in Adult Pulmonary Arterial Hypertension (PAH)

The majority of the research for Revatio (Sildenafil citrate) in adults with Pulmonary Arterial Hypertension (PAH) is primarily derived from Randomized Controlled Trials (RCTs). These studies were designed to compare the compound against a placebo, or "sugar pill," and focused on patients classified as WHO Functional Class II and III.

Researchers examined functional capacity, which included measuring how far patients could walk during a 6-minute walk distance (6MWD) test. They also monitored clinical events, tracking the time elapsed before documented clinical worsening was observed. Additionally, studies explored hemodynamic outcomes—measurements of blood pressure and resistance within the pulmonary arteries. Studies described measurements of 6MWD that differed between the groups receiving the compound and the groups receiving placebo. The research highlights changes measured during the study period for both functional and hemodynamic outcomes.

Evidence for Use in Pediatric Pulmonary Arterial Hypertension (PAH)

Research for Revatio was also evaluated in children and adolescents, typically those aged 1 to 17 years, who have PAH. These trials were generally small in size compared to the adult studies. For older children who could participate, studies examined functional capacity using the 6-minute walk test. However, for younger patients who are unable to perform this test reliably, research primarily monitored changes in pulmonary hemodynamics—the measurements of pressure and resistance in the lungs' blood vessels. Studies report how symptoms evolved in the observed populations during the defined time intervals.

Long-Term Research and Study Follow-Up

The core pivotal trials that established the initial evidence for Revatio were generally short-term, typically lasting 12 to 16 weeks. To gather information about the sustained observation, many patients who completed the initial trials were invited to participate in open-label extension studies. In these long-running studies, patients received the compound and were tracked over extended periods, sometimes for several years. This extended data provides insight into observations past the initial short-term trial period.

Evidence Gaps and Areas of Scientific Uncertainty

While research provides insight into short-term changes, there are still areas where certainty remains low or where data are still emerging. The long-term effects of the compound on the overall course of the disease and all-cause mortality are not fully established and have shown variability across different studies and dosages. Furthermore, follow-up durations were limited in the pivotal efficacy trials. Data for certain groups, such as adults with PAH classified as WHO Functional Class IV, remain insufficient. For pediatric patients, the primary limitation is the specific mortality observation from the extension study, which underscores that the evidence for certain groups requires ongoing evaluation. Research does not determine whether an individual will respond similarly, as study results reflect the specific conditions under which they were conducted.

Frequently Asked Questions (FAQ)

Common questions about Revatio (FAQ)


Q: Is Revatio considered a blood pressure lowering medicine?

A: Revatio (sildenafil) is a vasodilator, meaning it works by relaxing blood vessels. Its main purpose is to widen the arteries in the lungs to treat pulmonary hypertension. However, due to its action on the blood vessels, regulatory documents note that the medicine also causes mild and transient decreases in systemic (body-wide) blood pressure.


Q: Is it safe to consume alcohol while undergoing treatment with Revatio?

A: Official patient information indicates that consuming alcohol while taking this medicine is generally not recommended, as alcohol may intensify its blood pressure-lowering effects. This combination may increase the risk of experiencing adverse events like dizziness or fainting. Guidance on alcohol consumption is typically provided by a healthcare provider.


Q: Is Revatio sometimes prescribed for use in children?

A: Revatio is approved for use in pediatric patients 1 year of age and older. However, the FDA product labeling includes a specific warning against the chronic use of Revatio in most pediatric patients, based on clinical trial data showing increased mortality risk with higher doses in this population. Regulatory agencies specify that treatment is typically managed by a specialist.


Q: Are there age limits or specific cautions for older adults using Revatio?

A: Official product information notes that older adults, typically those ge 65 years of age, may experience reduced clearance of the active ingredient sildenafil from the body. This means the medicine may stay in the system longer, which could result in higher concentrations. Regulatory documents state that no initial dose adjustment is required, but increased plasma concentrations may necessitate closer clinical observation.


Q: What are the non-promissory general expectations for quality of life improvements with Revatio?

A: Clinical studies have demonstrated measured differences in exercise capacity (such as the 6-minute walk distance test) for adult patients with pulmonary arterial hypertension (PAH). The research also indicates the medicine is associated with delaying clinical worsening of the condition.


Q: Why is it important to take Revatio exactly as the prescribing healthcare professional directs?

A: Taking the medication exactly as prescribed, particularly regarding the timing of doses, is necessary for maintaining the required concentration of the drug in the body. According to regulatory instructions, consistent dosing supports the therapeutic goal and is intended to mitigate serious risks, such as severe hypotension (very low blood pressure).


Q: What studies have examined Revatio's use in patients with specific connective tissue diseases?

A: The clinical studies supporting the approval of Revatio for use in patients with pulmonary arterial hypertension (PAH) included individuals whose PAH was associated with connective tissue disease (CTD). This patient population is specifically noted in the official product labeling.


Q: Can Revatio be taken alongside common over-the-counter cold and flu products?

A: Official product and patient counseling information includes a statement that all over-the-counter (OTC) medicines used should be disclosed to a healthcare provider. This statement is given because certain ingredients in cold and flu products could potentially interact with Revatio, as potential interactions require a professional assessment.


Q: Are there any warnings about Revatio interacting with herbal supplements?

A: Regulatory sources include a statement noting that patients should inform their healthcare provider about all herbal supplements being used. This is a general caution because herbal supplements are often not tested for interactions with prescription medicines like Revatio, and some are known to affect drug blood levels.


Q: Is there any research on Revatio's effect on fertility in men or women?

A: Non-clinical data provided in the official documentation, based on studies in rats and rabbits, showed no evidence of impaired fertility or harm to the fetus. This information, conducted at specific high doses, is included in the regulatory assessment of the medicine.


Q: Is Revatio associated with changes in heart rate?

A: While not listed as a common side effect in clinical trials, postmarketing reports included in the regulatory records mention that increased heart rate (tachycardia) has been reported in patients taking the medicine. All potential side effects are documented in the full safety information.


Q: Does taking Revatio affect one's ability to drive or operate machinery?

A: Official patient information states that Revatio may cause side effects like dizziness or visual disturbances. For this reason, patients are cautioned in the official labeling about driving or operating machinery until they know how the medicine affects them.


Q: Why do official sources state that Revatio should not be taken with recreational drugs?

A: Official sources provide a strict warning that Revatio is absolutely contraindicated (must not be taken) with certain recreational drugs, specifically those containing nitrates such as 'poppers' (amyl or butyl nitrite). This combination can cause a sudden and dangerously severe drop in systemic blood pressure.

How should Revatio be stored and disposed of?

Storage and Disposal Requirements for Revatio

Revatio (sildenafil) storage conditions are defined by the pharmaceutical form.

Tablet Storage Conditions

Tablets must be stored at controlled room temperature, specifically between 20°C to 25°C (68°F to 77°F). The medication must be kept in the original, tightly closed container and secured out of the reach and sight of children.

Oral Suspension Handling and Stability

The reconstituted oral suspension can be stored in a refrigerator (2°C to 8°C) or at controlled room temperature (below 30°C), but it must not be frozen. Any unused suspension must be discarded after 60 days.

Disposal Instructions

Do not dispose of Revatio via wastewater or household waste (trash). Unused or expired medication must be handled according to local regulations, typically by consulting a pharmacist or following community take-back programs.

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

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