Aveed

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Aveed

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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 Aveed

Property Description
Active ingredient Testosterone Undecanoate
Form Sterile oily solution for intramuscular injection
Pharmacological class Androgen, Anabolic Steroid
General purpose Testosterone replacement therapy
Origin Synthetic androgen ester

AVEED is a specialized prescription medicine for injection, and its sole active ingredient is Testosterone Undecanoate. It is classified as an androgen, belonging to the larger pharmacological class of anabolic steroids. The manufacturer of AVEED is Endo Pharmaceuticals, positioning it as a distinct, long-acting option within the U.S. market.

This medication functions as a synthetic androgen ester, chemically derived from the natural hormone, Testosterone. The utility of testosterone esters in addressing hormonal deficits is recognized. The primary goal of AVEED is its use in testosterone replacement therapy to address confirmed clinical conditions in adult males associated with a deficiency or absence of endogenous testosterone. This is clinically recognized as the standard therapeutic approach for established hypogonadism.

Composition and Form: The Long-Acting Injectable

The active compound, Testosterone Undecanoate, is formulated as a sterile oily solution intended strictly for deep intramuscular injection. This formulation, which utilizes refined castor oil and benzyl benzoate, is designed to create a stable, oil-based reservoir.

This unique composition defines the drug as a long-acting injectable or depot injection, a distinctive feature among testosterone replacement options. The extensive chemical side chain allows the molecule to be slowly released from the muscle site over a prolonged period, ensuring consistent delivery. This characteristic allows for the maintenance of sustained hormone levels.

General Purpose and Mechanism: Restoring Hormone Balance

The general therapeutic purpose of AVEED is to aid in the restoration of serum testosterone to normal physiological levels in men with a confirmed deficit. As an ester, the Testosterone Undecanoate acts as a prodrug that is gradually metabolized within the body, releasing the potent active Testosterone.

This mechanism of slow activation and continuous release supports essential androgenic activity throughout the treatment interval. By providing a reliable, sustained supply of the hormone, the therapy is designed to mitigate the physical effects associated with the deficiency of endogenous testosterone, helping to return the patient's hormonal profile to a healthy, eugonadal state.

What side effects are possible with Aveed?

Official Classification of Side Effects and Safety Characteristics

The safety profile for testosterone undecanoate is documented based on post-marketing surveillance and clinical trials, classified by frequency and body system according to the standards established by regulatory authorities.

Systemic and Local Adverse Reactions

Reactions are officially documented across several System-Organ Classes. A Very Common adverse reaction, defined as occurring in 1 out of 10 people or more, involves the Blood and lymphatic system, specifically an increase in haematocrit (red blood cell volume).

Common side effects, occurring in up to 1 out of 10 people, include injection-site pain, hot flush, and acne. In the Reproductive System and Breast Disorders class, prostate enlargement (benign prostatic hypertrophy), an increase in Prostatic Specific Antigen (PSA), and gynecomastia (breast enlargement) are commonly noted.

Serious Adverse Reactions and Special Safety Constraints

The official labeling includes specific, potentially serious safety concerns. A recognized Rare adverse event is Pulmonary Oil Microembolism (POME), which may manifest immediately during or shortly after injection with symptoms such as coughing or dyspnoea. The profile also highlights an elevated risk for Venous Thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism, classified as an Uncommon reaction. Serious adverse cardiovascular events, such as myocardial infarction and stroke, are also documented.

Use of the medicine is contraindicated in all women and in men with known or suspected breast cancer or prostate cancer. Furthermore, specific safety considerations apply to older adults due to the heightened regulatory focus on prostate-related risks, and use is restricted in patients with severe renal or hepatic impairment.

Overdose and Emergency Response

The official regulatory documentation for Aveed (Testosterone Undecanoate) structures the potential for overexposure around two main profiles: acute post-injection events and the pharmacological effects of high-dose exposure.

Acute Emergency Events

The most serious events requiring emergency action are the immediate post-injection reactions: Pulmonary Oil Microembolism (POME) and Anaphylaxis. POME symptoms officially documented include the urge to cough, difficulty breathing (dyspnea), throat tightening, chest pain, dizziness, fainting (syncope), and sweating. Both POME and anaphylaxis are classified as potentially life-threatening and may require hospitalization.

When Immediate Medical Help is Required: Seek emergency medical services immediately for symptoms indicative of these serious events, or if symptoms worsen over the 24 hours after the injection. Following each injection, patients must be observed in the healthcare setting for a mandatory 30 minutes to provide appropriate medical treatment for these reactions.

Overexposure and Management

Symptoms associated with chronic high-dose exposure or abuse include psychiatric manifestations such as major depression, paranoia, and hostility, as well as severe cardiovascular events like cardiac arrest or stroke. Overdosage is generally managed by the mandated discontinuation of the drug and the use of appropriate symptomatic and supportive care; no specific antidote is known. Patients with pre-existing cardiac, renal, or hepatic disease are noted to have an increased risk of fluid retention, which may lead to congestive heart failure.

Therapeutic Uses of Aveed

The medication is used in situations involving certain distressing symptoms related to a confirmed deficiency or absence of endogenous testosterone, clinically known as male hypogonadism, in adult males. This therapeutic approach is commonly used to help with addressing systemic imbalance and relieving associated symptomatic distress; the therapy may assist with the management of these symptomatic presentations.

Therapeutic Benefit Domains

The therapeutic approach is relevant in contexts marked by increased discomfort or tension, used to help manage symptoms such as deficits in sexual function, physical decline, and changes in mood/energy. The medication is considered relevant in conditions presenting with systemic or localized discomfort, commonly used across conditions presenting with acute episodes of symptomatic discomfort, such as chronic fatigue, reduced libido, and decreased muscle mass.

“This therapy is applied in addressing the symptoms related to temporary physiological imbalance, which contributes to improved comfort during symptomatic phases.”

Quick Fact: Symptom Management for Systemic Imbalance

Aveed supports patients by assisting with the maintenance of lean body mass and bone health, while also contributing to easing the burden of related mood disturbances and chronic fatigue.

Eligibility and Restrictions for Use

The eligibility for using Aveed (Testosterone Undecanoate) is strictly defined by regulatory authorities and is limited to specific patient populations.

Populations Allowed

Aveed is approved for use only in adult males (aged 18 and older) who have a confirmed deficiency or absence of endogenous testosterone, clinically known as hypogonadism (Primary or Hypogonadotropic).

Absolute Contraindications

The medicine must not be used in the following groups, as stated in regulatory labeling:

  • Women (including pregnant women, due to the risk of fetal harm).
  • Men with carcinoma of the breast.
  • Men with known or suspected carcinoma of the prostate.
  • Individuals with a known hypersensitivity to the active ingredient or any excipients.
  • Men with a history of past or present liver tumours (as specified in European labeling).

Age and Condition Restrictions

  • Pediatric Use: Safety and efficacy have not been established for males under 18 years of age, and use is not recommended.
  • Geriatric Use: The safety and efficacy for treating men with "age-related hypogonadism" have not been established by the FDA.
  • Restricted Use: The medicine is not recommended for men with uncontrolled hypertension. Caution and monitoring are required for patients with pre-existing cardiac, renal, or hepatic disease due to the potential risk of edema.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the official interaction profile of Testosterone Undecanoate (Aveed) as documented by government regulatory agencies.

Interaction Classifications (High-Level)

Classification Official Regulatory Context
Requires Monitoring/Adjustment Oral Anticoagulants (e.g., Warfarin); Insulin/Hypoglycemic Agents
Caution/Additive Effect Corticosteroids or Adrenocorticotropic Hormone (ACTH)
Prohibited Combination Other Testosterone Products

Official Interaction Statements

Co-administration with oral vitamin K antagonist anticoagulants may increase anticoagulant activity, requiring more frequent monitoring of the International Normalized Ratio (INR) and prothrombin time. Concomitant use with corticosteroids or ACTH may enhance edema formation (fluid retention), an additive effect that is a particular concern in patients with pre-existing cardiac, renal, or hepatic disease. The medicine may also decrease blood glucose and insulin requirements in diabetic patients due to altered glucose metabolism.

Testosterone is noted as a potential moderate inducer of certain CYP enzymes; this pharmacokinetic pattern may theoretically decrease the plasma concentration of co-administered sensitive substrates. The use of Aveed is strictly prohibited with other testosterone products to avoid the risk of excessive androgen exposure. No specific timing separation rules or mandatory restrictions concerning food, alcohol, or herbal products are documented in the regulatory label for this injectable formulation.

Mechanism of Action

Aveed (testosterone undecanoate) is an androgen ester prodrug designed to function as a long-acting source of testosterone. Its mechanism begins with the drug's initial composition: the inactive undecanoate ester.

Upon intramuscular injection, endogenous non-specific esterases cleave the undecanoate fatty-acid chain from the testosterone molecule. This hydrolysis reaction initiates the release of active testosterone into the systemic circulation over an extended period.

Active testosterone, along with its metabolite dihydrotestosterone (DHT), acts by binding to the Androgen Receptor (AR), a ligand-activated transcription factor. This binding activates the genomic pathway, causing the AR complex to translocate to the cell nucleus to regulate the transcription of target genes.

This regulated gene expression leads to the synthesis of proteins that mediate the full spectrum of androgenic and anabolic effects. This process influences protein synthesis profiles in various tissues and modulates hematopoietic and neuroendocrine processes, resulting in the downstream modification of transcriptional activity characteristic of androgenic action.

Dosage and Administration Information

How Aveed is Administered

The use of Aveed is strictly controlled by a specific, mandatory protocol. This medicine is for intramuscular use only and must be administered by a certified healthcare professional in a healthcare setting.

Dosing Schedule and Frequency (Adult Males Only)

Before treatment initiation, the diagnosis of low testosterone must be confirmed by two separate morning serum testosterone measurements that are below the normal range. The fixed dosing schedule is as follows:

Dose Amount Timing of Injection
3 mL (750 mg) At initiation (first dose)
3 mL (750 mg) 4 weeks after the initiation dose
3 mL (750 mg) Every 10 weeks thereafter

Dosage titration is not required with this regimen.

Administration Procedure

Each injection of the 3 mL dose must be given deeply into the gluteal medius muscle (upper outer quadrant of the buttock). To minimize risk, the injection site must be alternated between the left and right buttock for consecutive doses.

During the injection process, the healthcare professional must aspirate for several seconds. If blood is drawn into the syringe, the dose must be immediately discarded, and a new dose prepared, as the drug is designed for muscle delivery, not intravenous administration. If no blood is aspirated, the dose must be delivered slowly and constantly over a period of 60 to 90 seconds.

Following every injection of Aveed, patients are required to remain in the healthcare setting and be observed for 30 minutes.

Recent Clinical Evidence

Research evidence / Overview of studies for Aveed

Evidence for Use in Confirmed Male Hypogonadism

Clinical research for this medication has was studied for adult men with a confirmed deficiency or absence of endogenous testosterone, known as hypogonadism. The primary evidence was observed in Phase 3 clinical trials that were generally open-label and non-comparative. The research primarily examined the drug's pharmacokinetic profile, monitoring whether average concentration level fell within the defined normal adult male range over the 10-week dosing interval. Findings from these trials reported patterns observed in the studies where the measured average concentration level was within the reference range for a large percentage of the hypogonadal men. Secondary research outcomes was evaluated in patient-reported experiences related to sexual function and mood.

Long-Term Research and Evidence Gaps

Follow-up research was observed in long-term extension studies, with some data collection extending up to 84 weeks (approximately 1.6 years). These studies monitored the continued stability of testosterone concentrations and collected ongoing descriptive information on systemic markers. However, follow-up durations were limited, and the long-term effects of this particular formulation remain uncertain beyond the observation period of the extension studies.

Regulatory bodies have stated that safety and effectiveness have not been established by dedicated research in males under the age of 18. Additionally, the official evidence record does not determine the utility of the injection in men presenting with age-related hypogonadism. The core limitation remains the primary reliance on the single-arm, non-comparative trial, meaning that comparative evidence is lacking for assessment against a placebo or other treatments.

Frequently Asked Questions (FAQ)

Common questions about Aveed (FAQ)


Q: Is Aveed the same type of medication as other testosterone injections?

According to official product information, Aveed (testosterone undecanoate) is an androgen ester, which is described as a formulation for testosterone replacement. It is chemically different from other common injectable esters, such as cypionate or enanthate, primarily because its unique long-acting formulation permits a dosing interval of up to 10 weeks after the initial starting doses.


Q: Do I have to register for a special program to get Aveed?

Official documentation indicates that the medication is dispensed only through a restricted program called the AVEED REMS Program (Risk Evaluation and Mitigation Strategy) in the U.S. This program is in place due to the potential for serious post-injection reactions. Healthcare providers and clinics must be certified to prescribe and administer the medication under this protocol.


Q: Is there a risk evaluation and mitigation strategy (REMS) associated with Aveed?

Regulatory documents confirm that Aveed is subject to a mandatory Risk Evaluation and Mitigation Strategy (REMS). This FDA-required program is designed to inform patients about the risk of serious post-injection events, such as Pulmonary Oil Microembolism (POME) and anaphylaxis. The REMS program includes the requirement that patients remain observed for 30 minutes following every injection.


Q: Can Aveed be used for bodybuilding or enhancing performance?

Regulatory agencies have approved Aveed only for use in men with a medically documented testosterone deficiency (hypogonadism). Official warnings note that the misuse or abuse of testosterone, often at higher than recommended doses, is associated with serious potential side effects. These risks include cardiovascular issues, negative mental health effects, and decreased fertility.


Q: Does Aveed cause weight gain or changes in appetite?

Official regulatory documentation describes that changes in appetite and unusual weight fluctuations (gain or loss) have been reported in association with the drug. Additionally, it is noted that the medication may cause edema (fluid retention), which can contribute to an increase in body weight.


Q: Can you drink alcohol while being treated with Aveed?

The official product labeling does not contain a specific prohibition or mandatory restriction regarding the use of alcohol while undergoing treatment. The safety information addresses only required restrictions and drug interactions.


Q: Does Aveed affect fertility or sperm count?

Official regulatory warnings specify that the introduction of external androgens like Aveed can suppress the body’s own hormone production. This suppression may lead to a dose-dependent decrease in sperm count, or even azoospermia (absence of sperm), effects that can impair the ability to conceive.


Q: Is Aveed a controlled substance?

Official documentation confirms that Aveed (testosterone undecanoate) is legally classified as a Schedule III controlled substance by the Drug Enforcement Administration (DEA). This classification indicates that the medication has an accepted medical use but also carries a recognized potential for abuse.


Q: Can Aveed interact with common over-the-counter medications?

The official label lists known interactions with prescription drugs, including oral anticoagulants and corticosteroids. While no specific over-the-counter (OTC) drugs are named, the drug has the potential to affect how the body metabolizes other medicines. Official guidelines emphasize the importance of disclosing all products being taken, including any over-the-counter medications.


Q: How soon after starting Aveed might a patient notice a change in symptoms?

Clinical trials for Aveed were primarily designed to show that the medication maintains testosterone concentration levels within the normal range. While improvements in patient-reported outcomes like sexual function and mood were studied, official labeling does not provide a defined or fixed timeline for the onset of specific symptom changes in individual patients.


Q: Does Aveed affect blood sugar levels?

Official regulatory information indicates that Aveed may affect blood sugar. Testosterone can alter glucose metabolism, which means it may decrease blood glucose and potentially lower the insulin needs of diabetic patients. For this reason, blood sugar levels may be subject to monitoring.


Q: Is Aveed safe for patients with kidney disease?

Regulatory documents state that patients with pre-existing renal disease (kidney disease) are at an increased risk for edema (fluid retention), which can be serious. Caution and vigilant monitoring of kidney function are noted as necessary. The medication is generally not used in patients with severe renal impairment.


Q: What are the long-term effects of using Aveed?

Clinical research, including extension studies, has monitored the drug for limited durations, typically up to approximately 1.6 years. According to regulatory summaries, the safety and effects of the medication beyond the observation period of the extension studies remain uncertain due to limited evidence.


Q: How does the time between Aveed injections compare to other methods?

Aveed is formulated as a long-acting depot injection, which provides an extended dosing interval. After the initial doses, injections are typically scheduled every 10 weeks, a period longer than the 2- to 4-week intervals typically associated with other testosterone injectable esters.


Q: What kind of monitoring is required while on Aveed?

Official guidelines describe that ongoing laboratory testing is recommended for patients receiving Aveed. This includes periodic checks of blood parameters such as hematocrit (red blood cell volume), hemoglobin, prostate-specific antigen (PSA), and lipid concentrations. Monitoring of blood pressure is also mentioned in regulatory information.


Q: How does Aveed relate to the body's natural testosterone production?

Regulatory documents indicate that as an external source of the hormone, testosterone replacement therapy like Aveed typically suppresses the body's natural production of testosterone. This occurs because the hormone levels achieved by the injection signal the body to reduce its own output via the hypothalamic-pituitary-gonadal (HPG) axis.


Q: What happens if I stop using Aveed suddenly?

The official label does not detail the process for discontinuing the drug. However, official warnings note that abruptly stopping high doses of testosterone may lead to withdrawal symptoms. These symptoms can include significant fatigue, depression, or loss of appetite, and may last for weeks or months.


Q: Can Aveed cause mood swings or psychological effects?

Official warnings indicate that testosterone therapy has been associated with various psychiatric effects, particularly in situations of misuse or abuse. These effects, as reported in regulatory documents, can include irritability, hostility, aggression, depression, and other psychological changes.


Q: Does the drug label mention anything about Aveed and sleep apnea?

The official labeling includes a warning regarding the potential risk of sleep apnea. Regulatory information indicates that treatment with testosterone may worsen or increase the risk of developing sleep apnea, particularly in individuals who are obese or have existing chronic lung conditions.


Q: Is Aveed an oily or watery solution?

Aveed is formulated as a clear, yellowish, sterile oily solution that is administered by deep intramuscular injection. This formulation utilizes refined castor oil, which forms the basis for the drug's oil-based composition. This allows the medicine to be slowly released from the muscle over an extended period.


Q: Are there different brands of testosterone undecanoate available?

Yes. Aveed is one specific brand of injectable testosterone undecanoate. Official drug databases indicate that other brands of testosterone undecanoate are also available in the market for testosterone replacement therapy, although they may be delivered through different routes of administration, such as an oral formulation.

How should Aveed be stored and disposed of?

How to Store and Dispose of Aveed?

Aveed (testosterone undecanoate) is a long-acting injectable product administered only by a healthcare professional in an office setting. This eliminates the need for patients to handle or store the medication at home.

Storage Requirements

Since Aveed is stored and prepared in a clinic, the following professional storage guidelines apply:

  • Temperature: Store at room temperature (20°C to 25°C or 68°F to 77°F). Brief excursions are permitted.
  • Protection: Keep the vials in their original carton to protect them from light.
  • Refrigeration: Refrigeration is not required and should be avoided.

Disposal of Unused Medication

All unused portions of the single-use vial, as well as the used injection materials, must be discarded by the healthcare professional according to required procedures for controlled substances and medical waste. Patients should not be responsible for the disposal of Aveed.

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

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