Reandron (Testosterone)

Quick links to important sections

Reandron (Testosterone)

Treatment option: Hypogonadism

Medically reviewed

Laura Arias

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 Reandron (Testosterone)

Quick Facts

Property Description
Active Ingredient Testosterone Undecanoate
Form Oily solution for intramuscular injection
Pharmacological Class Androgen (Anabolic Steroid)
General Purpose Hormone Restoration for Androgen Deficiency
Origin Synthetic hormone derivative

Defining Reandron: A Long-Acting Androgen Replacement

Reandron is a specific prescription-only medicine (POM) defined as a depot preparation and functions as a long-acting form of Hormone Restoration therapy. The medication is classified as an Androgen and is categorized as an Anabolic steroid due to the structure and biological activity of its core component; this specific ester is clinically recognized for sustained hormone delivery.

The primary purpose is to address states of androgen deficiency in adult men by providing replacement for the essential sex hormone testosterone. The use of this single-ingredient product is directed at achieving and maintaining necessary androgenic activity in men with confirmed hypogonadism, ensuring compensation for insufficient natural testosterone production. The distinctive feature of Reandron is its formulation for extended therapeutic effect, simplifying the long-term management of deficiency.

Active Component and Formulation: Testosterone Undecanoate

The active ingredient in this medication is Testosterone Undecanoate, a synthetic hormone derivative that represents an ester form of testosterone. The drug is supplied as an oily solution for intramuscular injection, a formulation necessary because the active component is highly soluble in lipids.

This specific dosage form utilizes an oily base, typically Castor Oil, to facilitate its role as an ultra long-acting agent. When administered via deep intramuscular injection, the preparation establishes a concentrated reservoir, or depot, within the muscle tissue, allowing for the subsequent gradual and stable release of the active hormone into the circulation. This long-acting profile enables a reduced frequency of administration compared to other testosterone preparations.

Purpose of the Ultra Long-Acting Design

The functional design of this medication is centered on its long-acting profile, which is achieved through the undecanoate ester modification. This design goal is to provide a highly consistent source of replacement hormone, avoiding the significant fluctuations in blood concentration often associated with shorter-acting testosterone preparations. The resulting steady-state delivery is crucial for hormone replacement, as it helps maintain biological systems reliant on adequate testosterone levels with minimal variation.

What side effects are possible with Reandron (Testosterone)?

The possible side effects and safety characteristics of testosterone undecanoate injections are formally documented and classified according to government regulatory standards, primarily using frequency categories and System-Organ Classes.

Officially Classified Adverse Reactions

Common adverse reactions (which may affect up to 1 in 10 patients) include the increase of Prostatic Specific Antigen (PSA) and elevated red blood cell levels (haematocrit/haemoglobin), requiring mandatory monitoring as per official labels. Other common effects documented in official sources are acne, weight gain, enlargement of the prostate (prostatomegaly), and discomfort or reaction at the injection site.

Uncommon adverse reactions (which may affect up to 1 in 100 patients) involve effects across several systems, such as depression, insomnia, aggression, headache, hypertension, and hair loss.

Serious Safety Considerations

Official regulatory documents highlight serious risks, including Pulmonary Oil Microembolism (POME) reactions, which are rare but can occur during or immediately following administration. The medicine is also associated with a documented risk of Venous Thromboembolism (VTE), such as deep-vein thrombosis and pulmonary embolism. The potential for anaphylaxis is also noted. Safety instructions require careful attention to patients with pre-existing cardiac, renal, or hepatic disease due to the documented risk of fluid retention (oedema). Long-term use requires ongoing monitoring for effects on the prostate, including the potential for worsening Benign Prostatic Hyperplasia (BPH).

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official overdose profile for Reandron (Testosterone Undecanoate) focuses on managing the consequences of excessive androgen exposure and associated acute risks, as documented in governmental regulatory sources.

Overdose of testosterone undecanoate is generally managed by discontinuation of the drug combined with appropriate symptomatic and supportive care, as no specific antidote is available.

Documented Overdose Signs and Manifestations

Symptoms that indicate excessive androgen exposure, and require medical consultation for dosage adjustment, include:

  • Irritability and Nervousness
  • Unexplained Weight gain
  • Prolonged or frequent erections

Urgent Medical Attention

Immediate medical help is required for severe complications that can be linked to high-dose exposure or steroid abuse. Patients should seek emergency care if they experience signs of:

Severe Condition Symptoms Requiring Urgent Care
Cardiovascular/Neurological Events Chest pains, difficulty breathing, slurred speech, or sudden severe headache.
Fluid Retention Severe oedema (swelling) with or without symptoms of congestive heart failure.

In all cases of suspected overdose, contact a healthcare professional or go to an Emergency Department, even if no discomfort is present, as officially advised in certain regulatory texts. Monitoring requirements may include regular measurements of serum testosterone and hematocrit.

Therapeutic Uses of Reandron (Testosterone)

What Reandron (Testosterone) Treats: Main Uses and Benefits

Reandron (testosterone undecanoate) is applied as a Testosterone Replacement Therapy (TRT) to manage the symptoms of male hypogonadism, which is a condition associated with a deficiency or absence of the hormone testosterone. The treatment is commonly used when deficiency is confirmed by clinical features such as asthenia and changes in body composition.

The medicine is used in situations involving certain distressing symptoms associated with low testosterone, including reduced sexual desire, erectile dysfunction, persistent fatigue, low mood, and physical changes such as decreased muscle mass. It is often applied during phases when symptoms become more noticeable, where supportive relief is needed. Quick Fact: Support for Functional Stability

Reandron provides support that helps ease the overall symptom burden, supporting patients during episodes of heightened discomfort. This may help patients cope more steadily with symptom fluctuations. The general clinical scenario assists with maintaining functional stability in men who require temporary symptomatic assistance.

Regulatory References

  1. New Zealand regulator Medsafe's data sheet on Reandron

Eligibility and Restrictions for Use

Reandron is officially authorized for use only in adult men who have a medically confirmed deficiency or absence of the body's natural hormone, testosterone (hypogonadism). This diagnosis must be established based on both clinical signs and consistently low testosterone levels verified by at least two separate laboratory blood tests.

Populations Who Must Not Use This Medicine

The medicine is strictly contraindicated (must not be used) for several specific populations, as outlined in official regulatory documentation:

  • Women (contraindicated during pregnancy and lactation).
  • Men who have or are suspected to have androgen-dependent carcinoma of the prostate or carcinoma of the male mammary gland (male breast cancer).
  • Men with past or present liver tumors.
  • Men with hypercalcaemia (high blood calcium levels) accompanying malignant tumors.
  • Individuals with a known hypersensitivity or allergy to the active substance (testosterone undecanoate) or any other ingredients.

Use Restrictions and Special Caution

Use of Reandron is not recommended for children and adolescents under 18 years of age as safety and efficacy have not been established. Caution is required for patients with severe cardiac, hepatic, or renal insufficiency, and treatment may be stopped immediately if severe fluid retention or congestive heart failure occurs. Caution is also advised for patients with uncontrolled hypertension or thrombophilia (an increased risk of blood clots).

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction profile of Reandron (Testosterone Undecanoate) based on governmental regulatory prescribing information. The information focuses strictly on documented drug-drug interactions.


Documented Interactions Requiring Caution or Adjustment

Interacting Product Category Officially Documented Effect Constraint/Requirement
Oral Anticoagulants (e.g., Warfarin) Increased activity (potentiated effect) of the anticoagulant. Requires close monitoring of coagulation status (INR) and possible dose reduction of the anticoagulant medicine.
Antidiabetic Agents (e.g., Insulin) May result in decreased blood glucose and reduced requirements for the antidiabetic medicine. Requires blood glucose monitoring and possible dose adjustment of the antidiabetic medicine.
Corticosteroids / ACTH Risk of enhanced oedema formation (fluid retention). Requires caution and monitoring, especially in patients with pre-existing cardiac, renal, or hepatic disease.

Interaction Classification Summary

  • Contraindicated Combinations: No specific drug-drug combination is formally classified as contraindicated due to an interaction risk in the regulatory labels for Reandron.
  • Metabolic/Transporter Interactions: Official prescribing information does not explicitly detail clinical interactions based on Cytochrome P450 enzymes or major transport proteins.
  • Food, Alcohol, or Supplements: No interactions with food, alcohol, or specific supplements are explicitly documented in the official labeling for the intramuscular injection formulation.

Mechanism of Action

Reandron, containing testosterone undecanoate, functions as a pro-drug. Following intramuscular injection into the depot tissue, the esterified compound is gradually hydrolyzed by non-specific serum esterases, yielding the active hormone testosterone and the pharmacologically inert undecanoic acid side chain.

Testosterone, the primary biological target ligand, subsequently circulates and enters target cells in androgen-responsive tissues, including muscle, bone, prostate, and adipose tissue. Intracellularly, testosterone acts as an agonist by binding with high affinity to the Androgen Receptor (AR), a ligand-activated transcription factor found in the cytoplasm.

Upon ligand binding, the activated AR-ligand complex translocates into the nucleus, binding to Androgen Response Elements (AREs) located on the DNA promoter regions of target genes. This molecular interaction modulates gene transcription, leading to either the up-regulation or down-regulation of specific messenger RNA (mRNA) production and subsequent protein synthesis. Furthermore, testosterone can undergo 5alpha-reduction by the enzyme 5alpha-reductase to the more potent AR agonist, dihydrotestosterone (DHT), which executes an identical AR-mediated genomic signaling cascade. These intracellular consequences collectively result in systemic physiological modulation, including shifts in body composition, regulation of hematopoiesis, and altered bone metabolism. The presence of exogenous testosterone also implements a negative feedback loop, causing suppression of the hypothalamic-pituitary-gonadal (HPG) axis by inhibiting the secretion of Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) from the pituitary gland.

Dosage and Administration Information

Administration Process

Reandron is an injectable form of testosterone undecanoate designed for deep intramuscular delivery. Because of the oil-based nature of the solution and the volume of the injection, it must be administered slowly by a healthcare professional. The injection is typically given into the gluteal muscle, taking care to avoid any blood vessels.

Injection Intervals

The medication is formulated to release testosterone gradually into the bloodstream over an extended period. This long-acting profile means that injections are spaced several weeks apart. The timing between sessions is determined by monitoring hormone levels to ensure they remain within a stable, physiological range.

Monitoring and Adjustments

At the beginning of therapy, the interval between the first and second injection may be shorter to reach the necessary steady-state levels more quickly. Following this initial phase, the maintenance schedule is individualized based on the patient’s clinical response and blood test results. Regular check-ups are necessary to confirm that the hormone replacement is maintaining consistent levels without significant fluctuations.

Recent Clinical Evidence

Recent Clinical Evidence for Reandron (Testosterone Undecanoate)

Reandron, a long-acting intramuscular injection of testosterone undecanoate (TU), is clinically established for treating male hypogonadism. Recent evidence has focused on long-term safety, efficacy, and its impact on broader health markers.

Clinical studies consistently show that Reandron effectively maintains serum testosterone levels within the normal (eugonadal) range for 10 to 14 weeks after the initial loading dose period. This prolonged dosing interval is a key feature and a significant advantage for patient adherence compared to shorter-acting formulations. Long-term studies, some extending beyond five years, demonstrate that the drug’s effectiveness in controlling symptoms of androgen deficiency, such as improvements in libido, sexual function, and overall quality of life, is sustained.


Impact on Body Composition and Bone Health

Testosterone replacement with Reandron has been shown to positively influence body composition. Clinical trial data indicate reductions in body fat and visceral fat mass, alongside an increase in lean body mass and muscle strength. Furthermore, evidence supports its benefit on skeletal health, with reports of increased bone mineral density (BMD), particularly in the lumbar spine and femoral neck, which is crucial for men with age-related or pathological hypogonadism and associated bone loss.


Safety and Cardiovascular Markers

The long-term safety profile of testosterone undecanoate is generally consistent with other forms of testosterone replacement therapy. Key safety monitoring involves checking for changes in Prostate-Specific Antigen (PSA) and hematocrit (HCT). While slight increases in both markers are commonly observed, long-term data suggest these typically remain within or stabilize in the normal reference range. For men with hypogonadism and concurrent metabolic conditions like metabolic syndrome, clinical trials have indicated that therapy can improve surrogate markers of cardiovascular risk, such as reducing insulin resistance and improving certain lipid profiles.

Key Studies & References DATA SHEET - REANDRON® 1000 (1000 mg/4 mL solution for injection)

Frequently Asked Questions (FAQ)

Common questions about Reandron (Testosterone) (FAQ)

Q: How is the term 'male hypogonadism' defined in official medical sources?

According to clinical standards referenced in official sources, male hypogonadism is a syndrome where the body doesn't produce enough testosterone. The diagnosis is based on consistently low testosterone levels in the blood combined with relevant physical signs or symptoms. The deficiency can stem from a problem in the testicles (primary hypogonadism) or in the brain signals that stimulate them (secondary hypogonadism).

Q: Is Reandron the same medication as Nebido or Aveed, which contain testosterone undecanoate?

Official regulatory documents confirm that Reandron is the same injectable formulation of testosterone undecanoate that is marketed under different brand names globally. This medication is known as Aveed in the United States and Nebido in many European countries. This means they all share the same active ingredient and long-acting design.

Q: Why is Reandron only administered via injection and not available as a daily gel or patch?

The medication is formulated as an oily depot injection designed to release testosterone slowly over an extended period. This method helps the body bypass first-pass metabolism (when the liver breaks down drugs taken orally) and ensures a gradual and sustained release of the hormone. This long-acting profile minimizes the significant fluctuations associated with shorter-acting forms.

Q: Is there a maximum number of years a person can safely use Reandron, according to long-term studies?

Official product information states that Reandron is intended for long-term therapy for confirmed hypogonadism. While no official label specifies a maximum number of years for continuous use, clinical data exists from long-term studies extending beyond five years. Ongoing monitoring is typically required during long-term therapy.

Q: What kinds of medical monitoring are described as necessary while a person is on Reandron therapy?

Regulatory guidelines describe that regular monitoring is needed to ensure both safety and effectiveness during treatment. Key laboratory tests include checking serum testosterone concentration to help determine the next dose, as well as Prostate-Specific Antigen (PSA) and hematocrit (red blood cell count). Monitoring for changes in blood pressure and signs of fluid retention is also necessary.

Q: Is it an expected part of the treatment for a patient to experience fluctuating symptoms near the end of the dosing interval?

The long-acting design of Reandron aims to maintain stable testosterone levels throughout the dosing interval. Official clinical studies suggest that patients rarely notice significant fluctuations in their symptoms near the end of the 10-14 week period. Regulatory guidelines require blood tests taken near the end of the interval to confirm that the medicine is maintaining acceptable hormone levels.

Q: How long does it generally take for patients to see the expected effects of Reandron on physical symptoms?

Official clinical studies indicate that while individual response varies, improvements in symptoms are generally noticeable within the first few months of starting therapy. Statistically significant increases in testosterone levels are achieved rapidly, with positive changes in sexual symptoms and quality of life often reported as early as 3 to 6 months after beginning treatment.

Q: Does Reandron carry an officially described risk or warning regarding the cardiovascular system?

Yes, official U.S. labels for testosterone products are required to carry warnings regarding a potential increased risk of heart attack and stroke. Official product information also warns that this medicine can cause an increase in blood pressure (hypertension), which requires regular monitoring.

Q: What signs of a severe allergic reaction are listed in the official documents for Reandron?

Regulatory documents list specific signs of a severe allergic reaction, or anaphylaxis, which can occur with this medicine. These signs may include hives or rash, swelling of the lips or tongue, difficulty breathing or swallowing, wheezing, coughing, dizziness, or fainting.

Q: What are the recognized risks of testosterone therapy in relation to male fertility and sperm production?

Official documents recognize that the use of testosterone therapy can impact male fertility. This occurs because the treatment can lead to the suppression of sperm production (spermatogenesis), which is a listed risk. This effect is generally dose-dependent, and is a factor to discuss when treatment is initiated.

Q: What is the process for monitoring prostate health (e.g., PSA levels) while a person is on Reandron?

Monitoring prostate health involves a combination of tests at the start of therapy and during treatment. This typically includes a Digital Rectal Examination (DRE) and a check of PSA levels (Prostate-Specific Antigen). These checks are usually performed at baseline and again within the first year, with continued checks following standard clinical guidelines thereafter.

Q: Is there an officially described precaution for using Reandron if a person has certain types of sleep disorders?

Yes, official patient information states that the medicine may cause or worsen a condition known as sleep apnea, where breathing stops and starts repeatedly during sleep. The risk of this side effect is reported to be greater for individuals who are overweight or who already have existing lung or breathing problems.

Q: How does the long half-life of Reandron affect the body's testosterone levels compared to daily gels or patches?

Official studies show the medicine has a long half-life (the time it takes for half the drug to leave the body) of approximately 90 days. This long half-life is what allows the injection to maintain effective testosterone levels within the normal range for an extended period of 10 to 14 weeks. This provides a much steadier level than shorter-acting daily applications.

Q: Has the FDA or other regulatory body issued any specific safety communications about injectable long-acting testosterone products?

Yes, major regulatory bodies, such as the FDA, have issued safety communications related to injectable long-acting testosterone products. These advisories have focused on the potential cardiovascular risks for testosterone products and mandatory strong warnings concerning the serious risks of Pulmonary Oil Microembolism (POME) and anaphylaxis.

Q: Why does official patient information mention that the medicine is banned from use in athletes?

Official regulatory documents classify testosterone as an anabolic androgenic steroid. Because of its potential for performance-enhancing effects, it is permanently banned from use in competitive sports by organizations like the World Anti-Doping Agency (WADA). The official WADA guidelines permit athletes to use such medications only if they have obtained a Therapeutic Use Exemption (TUE).

How should Reandron (Testosterone) be stored and disposed of?

The storage and disposal of Reandron (testosterone undecanoate) injection must follow strictly mandated requirements to maintain the product's stability and ensure safety.

Storage Conditions

Condition Requirement
Temperature Store below 30 C (Do not refrigerate or freeze).
Protection Keep the vial in the original carton to protect the oily solution from light.
Environment Store away from moisture and excessive heat.
Child Safety Must be kept out of the sight and reach of children.

Stability and Disposal

The product is for single use only. Any unused solution remaining in the vial must be discarded immediately after the required dose is withdrawn, and the product must not be used after the expiry date printed on the carton. Disposal of unused medicine and waste materials must be carried out in accordance with local requirements; medicines should not be thrown into household trash or wastewater.

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

Available in countries:

Equivalent of Reandron (Testosterone) found in:

A-Z Index: