Alprostadil Pfizer

Quick links to important sections

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 Alprostadil Pfizer

What is Alprostadil Pfizer?

Alprostadil Pfizer is a pharmaceutical formulation containing a synthetic version of prostaglandin E1 (PGE1), a naturally occurring substance in the human body. Prostaglandins are lipid compounds that exert various physiological effects, particularly on the vascular system and smooth muscle tissues.

Mechanism of Action

The primary function of alprostadil is to act as a vasodilator. When introduced to specific tissues, it interacts with smooth muscle cells, causing them to relax. This relaxation allows blood vessels to widen, which increases local blood flow. In the context of certain medical conditions, this mechanism is utilized to overcome physiological barriers to normal circulation.

Therapeutic Use

Alprostadil Pfizer is primarily utilized in the management of erectile dysfunction (ED). In men with this condition, the smooth muscles in the corpus cavernosum—the spongy tissue of the penis—often do not relax sufficiently to allow for the necessary blood inflow. Alprostadil works by directly stimulating these muscles to relax, facilitating the accumulation of blood required to achieve and maintain an erection.

Unlike some oral medications that rely on the presence of sexual stimulation to work through the nervous system, alprostadil acts directly on the vascular and muscular structure of the tissue. This makes it an alternative for individuals who may not respond to or cannot use other types of treatments.

Composition and Characteristics

As a synthetic analog of PGE1, the medication is designed to mimic the short-lived but potent effects of the body's own prostaglandins. Because it is rapidly metabolized by the body, its effects are generally localized to the area of application. The Pfizer formulation is produced under strict quality standards to ensure the stability and concentration of the active ingredient for clinical use.

Regulatory References

  1. Prostaglandin analogue
  2. vasodilator

What side effects are possible with Alprostadil Pfizer?

Official Classification of Possible Side Effects

The adverse reactions associated with Alprostadil have been classified based on frequency and affected System Organ Class (SOC) according to official regulatory documentation. This profile often distinguishes effects based on the route of administration, such as localized injection for erectile dysfunction or systemic infusion for neonatal cardiology.

Systemic and Local Reactions: Frequency Tiers

Penile pain is the most frequently reported adverse reaction, classified as Very Common (affecting more than 1 in 10 patients) following administration for erectile dysfunction . Common (affecting up to 1 in 10 patients) adverse reactions include penile fibrosis (e.g., angulation, Peyronie's disease), injection site hematoma or ecchymosis (bruising), and prolonged erection lasting less than six hours. Systemic effects such as headache and hypotension (decreased blood pressure) are also documented as common.

Documented Serious Adverse Reactions

Priapism, defined as a sustained erection lasting six hours or more, is documented as a potentially serious adverse reaction with a low frequency, necessitating immediate clinical attention according to official prescribing information. Repeated administration is associated with the risk of penile structural changes, including angulation or Peyronie's disease, which are grounds for treatment discontinuation. In the specific neonatal application, severe events such as apnea (cessation of breathing), seizures, and cardiac arrest are documented systemic risks, particularly in low-weight infants.

Population-Specific Safety Patterns

The safety profile for neonates is distinct and includes critical risks such as apnea, often appearing during the first hour of infusion, and the potential for gastric outlet obstruction with long-term infusion. Additionally, due to Alprostadil’s potent vasodilator effect, patients with pre-existing cardiovascular instability are noted to have an increased risk of hypotension and syncope.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory documentation identifies two principal categories of potential overdose with Alprostadil Pfizer: systemic overexposure and localized vascular effects.

Documented Overdose Manifestations

Systemic overexposure may result in profound hypotension (severe low blood pressure), often presenting as dizziness or syncope (fainting). A major localized manifestation of overdose is a prolonged erection, known as priapism, which regulatory bodies define as an erection lasting beyond four hours.

Population-Specific Considerations

In the specific context of intravenous use for neonates with congenital heart defects, overdose carries unique, severe risks, including apnea (temporary cessation of breathing) and severe bradycardia (slowed heart rate). Management of these systemic and cardiorespiratory effects requires continuous observation under medical supervision.

Emergency Action Mandate

Immediate medical attention must be sought if any signs of severe systemic overdose, such as syncope or collapse, are experienced. Additionally, the regulatory instruction is explicit: medical assistance must be obtained immediately for any erection that persists for longer than four hours to prevent the risk of tissue damage. In the event of an overdose, no specific antidote is known; therefore, treatment is limited to supportive and symptomatic care as administered by medical professionals.

Therapeutic Uses of Alprostadil Pfizer

Quick Facts: Alprostadil Therapeutic Domains

  • Erectile Dysfunction: Used in the management of erectile dysfunction (ED) in adult males.
  • Diagnostic Aid: Employed as an adjunct to other diagnostic tests to assist in the evaluation of ED.
  • Neonatal Cardiology: Utilized for the temporary, palliative maintenance of the patent ductus arteriosus in newborns who have congenital heart defects and require ductal patency for survival until corrective surgery can be performed.

Alprostadil, available from Pfizer under various brand names, is an established therapeutic option for the management of certain medical conditions. The primary approved use is for the treatment of erectile dysfunction (ED) in men, particularly when oral medications are considered ineffective or contraindicated. In this context, it functions to assist in achieving an erection suitable for sexual activity.

Additionally, the medication serves a significant role in diagnostics. It is approved as an aid to other clinical evaluations in the diagnosis of the underlying cause of ED.

A separate, vital indication is the temporary, palliative maintenance of the patent ductus arteriosus in neonates. This application supports newborns with congenital heart defects who depend on the continued patency of this duct to ensure necessary pulmonary or systemic blood flow until a definitive surgical intervention can be conducted.

Eligibility and Restrictions for Use

Official Eligibility Rules and Contraindications

The eligibility profile for Alprostadil Pfizer (intracavernosal/intraurethral formulation) is strictly defined by official regulatory documentation, focusing on contraindications and age-group restrictions.

Category Eligibility Status
Populations for whom use is allowed Adult Males for the treatment of erectile dysfunction.
Populations for whom use is contraindicated Males with conditions predisposing to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).
Males with anatomical deformation of the penis (e.g., severe angulation, Peyronie's disease), or those with penile implants.
Males for whom sexual activity is medically inadvisable due to underlying severe cardiovascular or respiratory conditions.
Age-related eligibility rules Not indicated for use in pediatric patients (non-neonatal children and adolescents).
Not indicated for use in females, including those who are pregnant or breastfeeding.
Condition-specific restrictions Patients on anticoagulants may have an increased risk of bleeding at the injection site; caution is required.

Connection to the overall eligibility profile

Official regulatory documents establish a clear boundary for use primarily by listing absolute contraindications related to penile anatomy and blood disorders that increase priapism risk. Eligibility is otherwise confined to adult males, with specific statements noting that the drug is not indicated for use in females or pediatric patients. No definitive guidelines are provided for use in patients with severe renal or hepatic impairment due to insufficient data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Alprostadil's interaction profile is characterized by pharmacodynamic effects stemming from its potent action as a vasodilator and platelet aggregation inhibitor, according to regulatory documentation.

Official Regulatory Restrictions

Co-administration with other treatments for erectile dysfunction is not recommended by regulatory agencies. This includes oral or other injectable vasoactive agents, as simultaneous use increases the risk of prolonged erection or priapism.

Pharmacodynamic Interactions

Interacting Product Category Officially Documented Outcome
Anticoagulants (e.g., Warfarin, Heparin) Increased propensity for injection site bleeding when Alprostadil is administered by injection.
Antihypertensives / Systemic Vasodilators Alprostadil may enhance the effects of these medicines, carrying a potential for additive hypotensive effects.
Sympathomimetics Co-administration may reduce the effect of Alprostadil.

Pharmacokinetic and Population Notes

The potential for pharmacokinetic drug-drug interactions (CYP- or transporter-mediated) has not been formally studied with many other agents. However, in patients with hepatic insufficiency, regulatory findings indicate that the plasma concentration ( C max) of the active component is significantly higher, suggesting altered clearance.

Mechanism of Action

Molecular Targeting of Prostaglandin EP Receptors

Alprostadil, a synthetic Prostaglandin E1 ( PGE1) analog, functions as an agonist by binding directly to specific Prostaglandin EP receptors (primarily EP2 and EP4 subtypes) on the smooth muscle cells of the targeted arteries and tissue. This localized interaction initiates the intracellular signal cascade.

️ cAMP Signaling and Smooth Muscle Relaxation

Receptor activation stimulates Adenylate Cyclase, which causes a sharp increase in cyclic AMP ( cAMP) levels. This second messenger modulates intracellular Calcium ( Ca^2+) concentrations, which directly triggers the significant localized smooth muscle relaxation in the helicine arteries and surrounding trabecular tissue.

Dual Hemodynamic Regulation (Inflow and Veno-Occlusion)

The tissue relaxation causes two co-dependent system-level effects: increased arterial inflow and consequential veno-occlusion (mechanical restriction of venous outflow). The mechanism is functionally dependent on the responsiveness of the targeted smooth muscle tissue; the action is physiologically constrained in the presence of structural issues like advanced arteriopathy. The combination of increased arterial inflow and restricted venous outflow dictates the localized hemodynamic profile.

Dosage and Administration Information

Administration Routes and Form

Alprostadil Pfizer is supplied as a lyophilized powder that requires aseptic reconstitution with a specified sterile diluent to form a solution before use. The medication is officially administered via two distinct routes depending on the indication. For adult use, the medicine is delivered through intracavernosal injection. Conversely, for the temporary treatment of neonates, it is administered as a continuous intravenous (IV) infusion into a large vein or umbilical artery catheter.


Dosing and Frequency Regimens

Official protocols require a dose titration phase to establish the appropriate individual dose. The initial intracavernosal dose typically begins at 2.5,mu g for most etiologies, or 1.25,mu g for pure neurogenic conditions, with subsequent increases made in specified increments. The dose must not exceed the recommended maximum of 60,mu g per injection. Maintenance use is strictly limited to a maximum of 3 times weekly, with a mandatory minimum interval of 24 hours between administrations. For neonates, the IV infusion is started between 0.05,mu g/ kg/ min and 0.1,mu g/ kg/ min, and subsequently reduced to the lowest possible rate that sustains the required temporary response.


Procedural Conditions and Use Duration

A primary procedural constraint requires that the first injection and initial dose titration must be conducted in a health care provider’s office by medically trained personnel. Patients are also instructed to alternate the injection site with each subsequent use. The successful adult dose is defined by an effect that does not exceed one hour in duration. The neonatal application is officially designated as a temporary and palliative course until definitive surgical correction can be performed.

Recent Clinical Evidence

Recent Clinical Evidence

The efficacy of Alprostadil (Pfizer) in treating erectile dysfunction (ED) has been investigated across multiple etiologies, including vasculogenic, neurogenic, psychogenic, and mixed causes. Clinical trials, including double-blind, placebo-controlled, and open-label studies, explored the drug's role in achieving and maintaining an erection sufficient for sexual intercourse.

Efficacy Outcomes in Trials

In major clinical studies involving the intracavernosal formulation, over 80% of participants reported achieving an erection judged to be adequate for sexual intercourse. In one placebo-controlled study, the use of Alprostadil resulted in a statistically significant response rate compared to placebo, with no response observed in the placebo group. The study findings also indicated a dose-response relationship, where the clinical response rates generally increased with higher doses of the medication.

Safety and Tolerability Profile

Trial data on Alprostadil reported that the most common adverse event was penile pain, which was generally transient and localized to the injection site. Serious adverse events were reported at low rates. In studies lasting up to 18 months, prolonged erection (lasting between 4 and 6 hours) occurred in approximately 4% of participants, and priapism (an erection lasting longer than 6 hours) was reported in less than 1% of patients. Penile fibrosis or curvature was also reported in a minority of participants during long-term follow-up, emphasizing the importance of ongoing monitoring.

Studied Dosing and Duration

Study protocols investigated doses ranging from 1.25 mcg to 60 mcg, with titration procedures used to determine the lowest dose that provided a satisfactory result without an erection lasting over one hour. The recommended frequency of use in clinical settings was no more than three times per week, with at least 24 hours between each application.

Key Studies & References

  1. CAVERJECT® IMPULSE (alprostadil) Clinical Studies | Pfizer Medical - US (includes efficacy and dosing data from key RCTs)
  2. Alprostadil - StatPearls (NCBI Bookshelf) (Includes general safety and adverse events summary)

Frequently Asked Questions (FAQ)

Common questions about Alprostadil Pfizer (FAQ)

Q: Is Alprostadil Pfizer the same drug as Caverject?

Alprostadil is the active ingredient contained within this medicine. Caverject and Caverject Impulse are brand names of the alprostadil injectable product manufactured by Pfizer. The official prescribing information refers to alprostadil as the core component responsible for the drug’s intended effects.


Q: How long can the effects of Alprostadil Pfizer be expected to last?

According to the official product information, the goal of treatment is to produce an effect suitable for sexual intercourse that lasts no longer than 1 hour. This duration is generally considered the therapeutic window when an appropriate individual dose has been determined.


Q: Are there any common over-the-counter medicines that are known to interact with Alprostadil Pfizer?

Regulatory documents indicate that using alprostadil with medicines that affect blood clotting, such as anticoagulants, may lead to interactions. Since certain over-the-counter products also have anticoagulant properties, official sources stress that caution must be observed due to a potential increase in bleeding or bruising at the injection site.


Q: Can Alprostadil Pfizer affect blood pressure or heart rate?

Yes, official documents list hypotension, or low blood pressure, as a common side effect associated with use. Changes in heart rate, such as tachycardia (a fast heartbeat) or bradycardia (a slow heartbeat), are also noted in the medication’s adverse reaction profile.


Q: Is it true that Alprostadil Pfizer can be stored at room temperature or does it always require refrigeration?

The storage requirements for the unreconstituted powder vary depending on the specific product form. Most forms are generally stored at a controlled room temperature. However, the product must not be frozen at any time.


Q: What kind of discomfort or pain is commonly reported with Alprostadil Pfizer use?

The most frequently reported adverse reaction is penile pain, which is typically transient and localized. Other types of discomfort documented in official materials include a warming or burning sensation in the penis, or aching in the testicles or perineum.


Q: What should a patient do if they miss an opportunity to use Alprostadil Pfizer as planned?

Regulatory documents state that use is generally limited to no more than three times per week, with a mandatory minimum of 24 hours between each application. Patients must simply ensure they adhere to the maximum frequency and minimum time interval rules.


Q: What are the requirements for a patient to be considered eligible for Alprostadil Pfizer therapy?

Official documents state that the medicine is indicated for use in adult males for the treatment of erectile dysfunction of various causes. Eligibility is defined primarily by the absence of specific contraindications, such as certain blood disorders, anatomical deformations of the penis, or severe underlying cardiovascular conditions.


Q: Why must Alprostadil Pfizer be used immediately after preparation according to instructions?

The reconstituted solution is typically described as stable for up to 24 hours when stored at a temperature between 36 F and 77 F (2 C to 25 C). It is not required for use immediately after mixing, but any unused portion of the solution must be discarded after 24 hours.


Q: Is Alprostadil Pfizer an opioid or a habit-forming substance?

Official regulatory documents classify alprostadil as a prescription-only medicine that is not scheduled or classified as a controlled substance under the Controlled Substances Act (CSA). The medicine is not known to be habit-forming.


Q: Is Alprostadil Pfizer available as a generic version or only under the Pfizer brand name?

Regulatory information indicates that, for the Pfizer-branded products, there is currently no generic version of the intracavernosal alprostadil available in the United States.


Q: Does using Alprostadil Pfizer affect fertility or the ability to have children?

Long-term studies examining the impact on human fertility have not been fully conducted. However, non-human studies using high doses did not show adverse effects on the production of sperm. The active ingredient itself is a substance naturally present in seminal fluid.


Q: Are there any official warnings about using Alprostadil Pfizer with alcohol?

Official regulatory patient information advises that the use of alcohol may potentially decrease the effectiveness of the medication. This topic is included for discussion with a healthcare provider.


Q: Do studies exist that examine the long-term use of Alprostadil Pfizer?

Clinical studies have examined the use of the intracavernosal formulation over periods of up to 18 months to assess its efficacy and safety profile. These data help inform the overall understanding of the drug’s effects.


Q: Is Alprostadil Pfizer used for any purposes other than those listed in the official patient information?

Alprostadil is officially approved for two primary medical purposes. These are the treatment of erectile dysfunction in adult men and the temporary maintenance of a patent ductus arteriosus in neonates with certain congenital heart defects.


Q: Are there any food or diet restrictions described in connection with Alprostadil Pfizer?

Official regulatory documents, such as patient information leaflets, do not describe any specific food or diet restrictions associated with the use of this medication.


Q: Is Alprostadil Pfizer ever used in women or children for any indication?

The formulation indicated for erectile dysfunction is not for use in women or non-neonatal children. However, the active ingredient, alprostadil, is approved for use via continuous intravenous infusion in neonates with specific congenital heart defects.


Q: Can patients with certain liver or kidney problems use Alprostadil Pfizer?

Official documents note that the drug’s metabolites are excreted primarily by the kidney. Caution is advised for patients with existing liver (hepatic) or kidney (renal) impairment due to the potential risk of accumulation of excipients. Official information indicates that a change to the dose may be considered in these patient groups.


Q: Are there any specific safety precautions listed for partners of people using Alprostadil Pfizer?

Regulatory documents note that the injection may cause a small amount of bleeding at the site. This could increase the risk of transmitting blood-borne diseases, including HIV, between partners. Regulatory documents emphasize the importance of counseling regarding protective measures.


Q: Does Alprostadil Pfizer have any known systemic (body-wide) effects?

While the primary action is local and targeted, systemic (body-wide) effects are documented in the adverse event profile. Common systemic reactions listed include headache and hypotension (low blood pressure), as the drug's potent vasodilator property can be absorbed into the central circulation.


Q: Can Alprostadil Pfizer interact with supplements or herbal products?

The medication is known to interact with certain classes of prescription medicines. While formal studies on all supplements or herbal products have not been conducted, official guidance stresses that a healthcare provider should be aware of all non-prescription products being used.


Q: Is it safe to travel with Alprostadil Pfizer, and what are the specific storage concerns?

Unreconstituted product is generally required to be stored at a controlled room temperature. Official information notes that the product may tolerate short excursions outside of the specified temperature range, such as during travel. The medication must be protected from freezing.


Q: What documentation or studies support the regulatory approval of Alprostadil Pfizer?

Regulatory approval is based on data submitted to official agencies like the FDA. This documentation includes results from clinical trials, such as double-blind, placebo-controlled studies, that assessed the drug's efficacy and safety profile.


Q: Are there special considerations for older patients using Alprostadil Pfizer?

Official clinical studies have included patients with a mean age of 60 years and older. While there is no separate dosing guidance provided solely based on advanced age, regulatory information does not suggest that altered efficacy or safety is expected in geriatric patients.


Q: Do regulatory agencies classify Alprostadil Pfizer as a controlled substance?

Regulatory agencies, such as the US FDA, classify alprostadil as a prescription-only medicine. It is not scheduled or classified as a controlled substance under federal law.


Q: Does Alprostadil Pfizer interfere with or prevent sexually transmitted disease transmission?

No, official regulatory information explicitly states that alprostadil does not offer protection from the transmission of sexually transmitted diseases (STDs), including HIV.


Q: Can patients with diabetes use Alprostadil Pfizer?

Clinical trial data indicate that the use of antidiabetic agents, including insulin, did not appear to affect the efficacy or safety profile of the medication. Official guidance notes that the use of this medicine in patients with diabetes is a matter for discussion with a healthcare provider.


Q: What are the signs of an overdose described for Alprostadil Pfizer?

The main clinical finding associated with an overdose following intracavernosal injection is a sustained erection, particularly priapism (an erection lasting longer than 6 hours). Systemic symptoms of overdose may also include fainting, dizziness, or blurred vision.

How should Alprostadil Pfizer be stored and disposed of?

How to Store and Dispose of Alprostadil Pfizer?

Strict adherence to labeled storage conditions is required to maintain the stability and effectiveness of this product.

Product Form Storage Temperature (Unreconstituted) Stability After Reconstitution
CAVERJECT IMPULSE 68 F to 77 F (20 C to 25 C) Use within 24 hours (when stored at leq 77 F)
CAVERJECT 20 mcg Vial 68 F to 77 F (20 C to 25 C) Use within 24 hours (when stored at leq 77 F)
CAVERJECT 40 mcg Vial 36 F to 46 F (2 C to 8 C) initially Use within 24 hours (when stored at leq 77 F)

Handling Requirements: Do not freeze the product. The reconstituted solution must not be refrigerated. Inspect the solution visually for particles or discoloration before use. Gently swirl the vial to dissolve the powder; do not shake.

Disposal: Alprostadil is for single use only. Used needles and syringes must be immediately placed in an FDA-cleared sharps disposal container. All medicines must be kept out of the reach of children.

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

Available in countries:

Equivalent of Alprostadil Pfizer found in:

A-Z Index: