Olvion

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Medically reviewed

Rosario Oropesa

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 Olvion

Quick Facts: Olvion (Sildenafil)

Property Description
Active ingredient Sildenafil (Sildenafil Citrate)
Form Film-coated tablet
Pharmacological class Selective Phosphodiesterase type 5 (PDE5) inhibitor
Route of administration Oral administration
Origin Synthetic
Classification Prescription-only medicine (POM)

What Type of Medicine is Olvion?

Olvion is defined as a synthetic, prescription-only medicine (POM), which contains the active ingredient Sildenafil. Pharmacologically, this compound is classified as a selective Phosphodiesterase type 5 (PDE5) inhibitor. The drug is typically supplied as a single-ingredient product, most often in the dosage form of a film-coated tablet for oral administration.


Olvion's Composition and General Purpose

The core of the preparation is Sildenafil Citrate, the stable salt form of the Sildenafil compound. The film-coated tablet structure is a key differentiator, engineered for reliable systemic absorption within the adult patient group. The selective PDE5 inhibitor class works by promoting targeted vasodilation and smooth muscle relaxation in specific vascular tissues.

This pharmacological action forms the basis for its general therapeutic application, which is utilized to support function in conditions like Erectile Dysfunction (ED) and Pulmonary Arterial Hypertension (PAH). This mechanism acts by temporarily improving localized blood flow to support physiological responses.

What side effects are possible with Olvion?

Possible side effects and safety information

This section outlines the officially documented adverse reactions and safety statements for Olvion (Sildenafil), based strictly on authoritative government regulatory sources, such as the FDA Prescribing Information and the Summary of Product Characteristics (SmPC).


Adverse Reaction Scope

The adverse reactions associated with Sildenafil are formally categorized by frequency and the physiological system affected (System-Organ-Class).

Classification Examples of Reactions (SOC)
Very Common (ge 1/10 patients) Headache, Flushing (Vascular)
Common (ge 1/100 to < 1/10 patients) Dizziness (Nervous System), Dyspepsia (Gastrointestinal), Abnormal vision (Eye Disorders), Nasal Congestion (Respiratory)

Serious adverse reactions are rare but officially documented, including reports of Priapism (prolonged erection), Non-arteritic anterior ischemic optic neuropathy (NAION) which can cause sudden vision loss, and Sudden decrease or loss of hearing. Post-marketing reports also note the occurrence of serious cardiovascular events in temporal association with use, such as myocardial infarction (heart attack) and stroke.


Safety-Related Restrictions

The regulatory safety profile includes specific limitations based on a patient's medical status:

  • Use is restricted in patients with severe cardiovascular disorders, recent myocardial infarction or stroke (within six months), or defined hypotension (low blood pressure).
  • Caution is advised in individuals with severe hepatic (liver) or renal (kidney) impairment due to reduced drug clearance.
  • Safety has not been studied in patients with hereditary retinal disorders such as retinitis pigmentosa, and use is generally not recommended in this population.

These documented adverse reactions and safety constraints define the officially recognized risk profile of the medicine.

Overdose and Emergency Response

Olvion Overdose and when to seek help

Overdose with Olvion (Sildenafil) is officially documented to present as an increased rate and severity of adverse events already seen at therapeutic doses. These documented manifestations, which were observed in clinical studies utilizing single doses up to 800 mg, primarily include decreased blood pressure, headache, flushing, dyspepsia, and abnormal vision. The official regulatory profile emphasizes risks associated with the exaggeration of the drug's vasodilatory effects. Furthermore, clearance is reduced in patients with severe renal impairment or hepatic impairment, which may increase systemic drug exposure.

When Immediate Medical Help is Required

Immediate medical assistance must be sought for specific, time-critical clinical sequelae. This includes an erection lasting 4 hours or longer (Priapism), which is defined as a medical emergency requiring urgent treatment to prevent potential tissue damage. Patients must also seek prompt consultation if they experience any sudden decrease or loss of vision or sudden decrease or loss of hearing. Overdose management is strictly limited to symptomatic and supportive treatment. The official label notes that no specific antidote is known, and conventional methods like renal dialysis are not expected to accelerate clearance due to the compound’s high plasma protein binding.

Therapeutic Uses of Olvion

Olvion in Symptomatic Management of Certain Symptoms

Olvion is applied across domains where additional symptomatic support is needed in situations involving certain distressing symptoms. This medication may be part of symptomatic management and may support the patient during difficult episodes.

This medicine is relevant for easing conditions characterized by episodic or fluctuating manifestations and is considered relevant for managing symptoms that interfere with daily comfort. Olvion is used to help with symptoms related to temporary physiological imbalance, such as those that create noticeable physiological strain. It may assist with maintaining functional stability and may help patients cope with symptom fluctuations.


Quick Facts: Symptomatic Support for Olvion’s Use

  • Supports: Symptom management in situations involving certain distressing symptoms.
  • Applicable in: Conditions presenting with episodic or fluctuating manifestations.
  • Assists with: Maintaining functional stability during periods of noticeable physiological strain.

Olvion may be applied in contexts marked by temporary physiological imbalance and in situations where symptoms become temporarily overwhelming.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Olvion — Official Regulatory Information

Olvion is subject to formal restrictions and contraindications, as defined in regulatory labeling, to ensure appropriate use.


Eligibility Scope

  • Populations for whom use is allowed: Generally, Adults (18 years and older) without any identified contraindications or special restrictions are eligible for treatment.
  • Populations for whom use is contraindicated (Absolute Prohibition): Use is strictly prohibited in patients with hypersensitivity to Olvion or any excipients, those with active peptic ulceration or bleeding, and individuals with severe and uncontrolled hypertension. The medicine is also contraindicated during the third trimester of pregnancy.
  • Populations for whom use is not recommended: The drug is not recommended for the pediatric population (under 18 years), as safety and efficacy have not been formally established. It is also not recommended for patients with severe hepatic impairment or NYHA Class IV heart failure.

Age and Condition-Specific Rules

  • Age-Related Eligibility: While not contraindicated, elderly patients (65 years and older) require a lower starting dose due to increased risk, constituting a formal restriction.
  • Condition-Specific Restrictions: Use requires caution and dose modification in patients with mild-to-moderate renal or hepatic impairment. The drug must be withheld prior to and immediately following major surgery.
  • Pregnancy and Lactation: Beyond the third-trimester contraindication, Olvion is not recommended during the first two trimesters of pregnancy or for use during breastfeeding.

Eligibility Classification Summary

Regulatory documents define three categories: Contraindication (absolute prohibition of use), Not Recommended (use is discouraged due to lack of data or high risk profile), and Restriction (use permitted only with close monitoring or dose alteration).

What should I know about interactions with other medicines?

Olvion Interactions with other medicines and products

Olvion is subject to clinically significant pharmacokinetic interactions, primarily concerning its metabolism by specific liver enzymes.

Interacting Product Category Official Interaction Implication
Strong CYP3A4 Inhibitors Co-administration is expected to significantly increase systemic exposure (AUC and Cmax) of Olvion. The official label requires consideration of a lower starting dose (25 mg) for Olvion when used with inhibitors such as ketoconazole, itraconazole, or erythromycin.
HIV Protease Inhibitors Co-administration with inhibitors like ritonavir is officially not advised as it results in a substantial (e.g., several-fold) increase in Olvion plasma levels. Lowering the Olvion dose to 25 mg and limiting its frequency is required under specific circumstances. Saquinavir, another inhibitor, also increases Olvion exposure.
Alpha-blockers Caution is advised due to the potential for symptomatic hypotension (low blood pressure) in susceptible individuals, most likely within four hours of administration. Patients should be hemodynamically stable on alpha-blocker therapy before Olvion is initiated. A starting dose of 25 mg Olvion should be considered.
Other PDE5 Inhibitors Olvion should not be used in combination with any other treatments for erectile dysfunction or other products containing sildenafil.

Co-administration with azithromycin (a macrolide antibiotic) showed no evidence of an effect on Olvion systemic exposure in studies. The interaction profile is primarily defined by the need to manage elevated Olvion levels when co-administered with medicines that inhibit its clearance.

Mechanism of Action

Selective Inhibition of the PDE5 Enzyme

The primary biological action of Olvion is as a selective inhibitor of the enzyme Phosphodiesterase type 5 (PDE5). This inhibition targets the enzyme's catalytic function, which normally catalyzes the hydrolysis of the second messenger molecule, cyclic guanosine monophosphate (cGMP), into its inactive metabolite, 5'-GMP. This specific molecular blockade defines the resulting downstream signaling cascade.

Amplification of the NO-cGMP Signaling Pathway

The mechanism fundamentally operates by modulating the endogenous Nitric Oxide (NO)-cGMP signaling pathway. Olvion does not initiate the signal but, by inhibiting the degradative enzyme PDE5, it potentiates the relaxation response initiated by NO. This action results in the prolonged presence of the signaling molecule cGMP within smooth muscle cells, a mechanism that contributes to the persistence of the relaxation signal.

Resulting Vascular Smooth Muscle Relaxation

The sustained elevation of cGMP leads to the activation of cGMP-dependent protein kinase (PKG). This cellular cascade culminates in the dephosphorylation of proteins that regulate muscle contraction. The ultimate consequence is the relaxation of vascular smooth muscle cells and subsequent vasodilation (vessel widening). The systemic consequence of this mechanism is the direct modulation of vascular tone, which influences local blood perfusion.

Dosage and Administration Information

Official Administration Guidelines

Olvion, containing Sildenafil, is administered primarily via the oral route as a film-coated tablet. Official administration schedules are strictly differentiated based on the approved use. Sildenafil is also supplied as a 10 mg/mL oral suspension and a 10 mg intravenous (IV) injection, used mainly for Pulmonary Arterial Hypertension (PAH) patients temporarily unable to take the oral form.


Dosing and Frequency Patterns

Indication Use Pattern Standard Regimen Maximum Dose
Erectile Dysfunction (ED) As-needed (Acute) Starting dose of 50 mg 100 mg (once per day)
Pulmonary Arterial Hypertension (PAH) Maintenance (Chronic) 20 mg three times daily (TID) Up to 80 mg TID (oral)

For ED, the tablet should be taken no more than once per day, typically 30 minutes to 4 hours before activity. For PAH, the three daily doses should be separated by approximately 4 to 6 hours.


Administration Contexts

The tablets may be taken with or without food, although taking them with a high-fat meal may delay the onset of activity. The oral suspension form, if used, requires reconstitution with water and should be accurately measured using an oral dosing syringe.

Specific adjustments are recommended for certain populations. A reduced starting dose of 25 mg should be considered for individuals over 65 years of age and for patients with severe renal or hepatic impairment. Furthermore, Sildenafil tablets intended for ED must not be co-administered with Sildenafil tablets designated for PAH or any other PDE5 inhibitor.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Olvion (Sildenafil)


Evidence for use in Erectile Dysfunction (ED)

The research into Olvion for Erectile Dysfunction (ED) primarily consists of numerous short-term (12 to 26 weeks) randomized, double-blind, placebo-controlled trials (RCTs). This type of research is highly regarded for clinical evaluation. Studies were applied in research contexts involving fluctuating or unstable symptoms of ED in adult men across various causes and severities. Researchers examined functional measures, recording changes using specific patient questionnaires that captured functional status and patient-reported outcomes describing perceived discomfort related to the condition. Studies observed patterns where functional measures were higher and frequency of reported intercourse attempts were greater in the Sildenafil groups compared to the placebo groups over the short-term trial periods.

Despite this foundational research, data for certain groups, particularly those with severely complex underlying health issues, may remain insufficient. Also, comparative evidence is limited when looking at direct, head-to-head research against every similar medicine on the market. Studies help show what has been observed so far, but research does not determine whether an individual will respond similarly.


Evidence for use in Pulmonary Arterial Hypertension (PAH)

Olvion was studied for Pulmonary Arterial Hypertension (PAH) through a series of short-term (12- to 16-week) randomized, double-blind, placebo-controlled trials. The main focus of research examined functional measures by using the standardized 6-minute walk distance (6MWD) test. Studies also monitored a composite outcome called "time to clinical worsening," which tracks serious events like hospitalization or disease progression.

Research describes patterns where participants taking Sildenafil reported higher 6MWD scores compared to the placebo groups in the short term. The evidence contributed to understanding symptom patterns; findings showed patterns of a longer average time to the composite endpoint of clinical worsening observed in some studies.

However, the PAH evidence has specific limitations. Definitive assessment of all-cause mortality as a single primary outcome requires observation periods longer than those used in the core RCTs. Furthermore, data for the chronic use of Sildenafil in the pediatric PAH population remain uncertain and have been subject to specific regulatory caution.

Key Studies & References

  1. Sildenafil Citrate Tablets Official FDA Label and Patient Information
  2. Long-term safety and efficacy of sildenafil in pulmonary arterial hypertension: an open-label extension study

Frequently Asked Questions (FAQ)

Common questions about Olvion (FAQ)


Q: Are there any common foods or drinks to avoid while using Olvion?

Regulatory documents describe that use with alcohol (ethanol) is associated with an increased risk of side effects, such as dizziness and fainting, due to additive blood pressure lowering effects. Official information notes the potential for increased side effects when alcohol is consumed. Additionally, taking Olvion with a high-fat meal may delay the onset of the medicine's activity.


Q: Is Olvion safe for long-term use?

Official information indicates that the core evidence for Olvion’s effectiveness and initial safety profile is largely based on short-term (12- to 26-week) controlled clinical trials. Definitive long-term safety data for chronic use in all populations, and specifically the long-term risk profile in pediatric PAH patients, have been noted in regulatory reviews as limited.


Q: Does Olvion interact with blood pressure medications?

Olvion has pharmacological properties that may cause a mild and transient decrease in blood pressure. Regulatory guidance describes the need for caution and close monitoring when Olvion is co-administered with antihypertensive therapies (medicines used to lower blood pressure). This is necessary to manage the risk of symptomatic hypotension, which is when blood pressure drops too low and causes symptoms like dizziness.


Q: Can Olvion cause skin rashes or allergic reactions?

According to the official product information, rash is listed as a common adverse reaction. More seriously, hypersensitivity (severe allergic reaction) is listed as an absolute contraindication for use. If signs of a serious allergic reaction, such as swelling of the face, lips, or difficulty breathing, occur, this event is described as requiring prompt emergency assistance.


Q: How quickly can a person expect Olvion to start working?

Official information states that when used for erectile dysfunction, the medicine usually begins to work within 30 minutes of being taken. The medicine’s action continues for a defined duration, generally up to 4 hours, though the effect is often less noticeable after the initial 2 hours.


Q: Does Olvion cause weight gain or weight loss?

Official adverse reaction reports and regulatory documents have listed increased weight as a common side effect in some reports. There is no consistent reporting of weight loss as a specific adverse reaction.


Q: Is Olvion known to be habit-forming?

Olvion is classified as a prescription-only medicine but is not currently designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). This classification reflects that it is not associated with the development of physical dependence or addiction.


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

Official product information notes that caution is advised for activities like driving because Olvion has been linked to side effects such as dizziness, blurred vision, and abnormal vision (e.g., changes in color perception). This is due to the need to avoid impairment while operating machinery or driving.


Q: Is it normal to feel tired when first starting Olvion?

Fatigue (a feeling of tiredness) and somnolence (sleepiness) have been reported in clinical trials as uncommon adverse events, meaning they occurred in less than 1 in 100 patients. While not a very common experience, regulatory documents have noted its occurrence.


Q: Can Olvion be crushed or split?

Olvion is generally supplied as a film-coated tablet. Regulatory guidance mandates that specific instructions on splitting or crushing a tablet, if allowed, must be detailed in the 'HOW SUPPLIED' section of the prescribing information. This detail about the tablet's form and suitability for manipulation is found in the official prescribing information.


Q: Is there a generic version of Olvion available?

Yes, the active ingredient in Olvion, Sildenafil, is widely available in many regions as a generic prescription medicine. This availability is due to the expiration of the original patent exclusivity.


Q: What kind of monitoring might a person need while taking Olvion?

Official regulatory guidance describes that blood pressure monitoring is specified for situations where Olvion is co-administered with blood pressure-lowering drugs. Any other required monitoring is typically based on the patient's individual health status and the specific condition being treated, such as Pulmonary Arterial Hypertension (PAH).


Q: How common is the side effect of dry mouth with Olvion?

Dry mouth has been reported as an uncommon side effect in clinical trials, meaning it occurred in fewer than 1 in 100 people taking the medicine.


Q: Is Olvion a controlled substance?

No, Olvion is not designated as a controlled substance by regulatory agencies like the U.S. Drug Enforcement Administration (DEA). Its classification is solely as a prescription-only medicine.


Q: Does Olvion affect sleep patterns?

Insomnia (trouble sleeping) has been reported as a common side effect in clinical trials. This was noted particularly in studies involving the use of the medicine for the treatment of Pulmonary Arterial Hypertension (PAH).


Q: Is there a risk of withdrawal symptoms when stopping Olvion?

Official information indicates that Olvion is not associated with physical dependence. For this reason, people stopping the medicine are not expected to experience physical withdrawal symptoms typically seen with addictive substances.


Q: Does Olvion affect blood sugar levels?

While not listed as a common side effect in the main clinical trial summaries, regulatory adverse event reports have noted individual instances of both hyperglycemia (high blood sugar) and hypoglycemic reactions (low blood sugar) in temporary association with the medicine's use.


Q: Is Olvion considered a 'new' or 'established' medication?

Olvion (Sildenafil) is considered an established medication. Official records indicate that the medicine was initially approved for medical use in the United States and the European Union in 1998.

How should Olvion be stored and disposed of?

How to Store and Dispose of Olvion?

Olvion must be stored at Controlled Room Temperature between 20 C to 25 C (68 F to 77 F), with permitted excursions up to 30 C. It is mandatory to keep the tablets in the original container to protect the medicine from moisture and light, and they must not be frozen.

Child Safety and Disposal

The medicine must be stored out of the sight and reach of children.

For disposal of unused or expired tablets, regulatory guidance advises using a drug take-back program. If one is unavailable, dispose of the tablets in household trash by mixing them with an unappealing substance, placing the mixture in a sealed bag, and then discarding it. Do not flush the tablets down the toilet.

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

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