Andriol

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Andriol

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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 Andriol

What is Andriol? Overview and Identity

Property Description
Active ingredient Testosterone undecanoate
Form Soft capsules (Oral preparation)
Pharmacological class Androgen; Sex hormone replacement
General use Androgen Replacement Therapy
Origin Synthetic (Prodrug)

Andriol's Identity: A Synthetic Androgen Replacement

Andriol is a recognized prescription medicine utilized as a synthetic androgen, formally classified as an anabolic steroid and a sex hormone replacement preparation. The foundational element is its active ingredient, Testosterone undecanoate, which constitutes a modified ester of the natural Testosterone hormone. This medication serves as a highly specific male sex hormone analogue. The necessity of the synthetic Testosterone undecanoate lies in its design to facilitate oral delivery, which is a distinguishing feature from other androgen options.

Composition and Unique Oral Formulation (Soft Capsule)

The product is presented as a single product in the form of an oral preparation, specifically a soft capsule, a feature that differentiates it from injectable or transdermal testosterone delivery systems. Within the capsule, Testosterone undecanoate is fully dissolved within an inert oil solution. This oil vehicle is a deliberate formulation strategy that guides the absorption of the active compound via the lymphatic system, rather than subjecting it to immediate hepatic clearance. This unique route of administration is clinically recognized for ensuring systemic bioavailability and is central to the identity of this oral androgen preparation.

General Purpose: Treating Testosterone Deficiency

The fundamental purpose of this androgen medication is to provide hormone replacement therapy. It is primarily intended to restore and maintain adequate physiological levels of Testosterone in adult males diagnosed with a clinically confirmed deficiency, a condition termed hypogonadism. The therapy aims to stabilize the bodily functions that rely upon sufficient androgen concentrations. While other forms of testosterone therapy are available, Andriol is positioned specifically for patients requiring a non-injectable, gastrointestinal route for androgen replacement therapy.

What side effects are possible with Andriol?

Possible Side Effects and Safety Information

The safety profile for oral testosterone undecanoate (Andriol) is organized by regulatory agencies using standardized frequency and system classifications.

Frequency-Classified Adverse Reactions

Adverse reactions are classified based on official clinical and post-marketing data. Effects categorized as Common (affecting 1 in 10 to 1 in 100 people) include increased blood pressure (Hypertension), increased hematocrit (red blood cell volume), increased Prostate Specific Antigen (PSA) levels, and weight increase. Less frequent reactions are categorized as Uncommon or Rare.

System-Organ Class Effects

Regulatory documents group potential effects by the physiological system involved. Noted system-organ classes include Vascular Disorders (e.g., hypertension), Reproductive System and Breast Disorders (e.g., gynecomastia, worsening of BPH), and Metabolism and Nutrition Disorders (e.g., fluid retention or edema).

Serious Adverse Reactions and Safety Constraints

The official labeling documents the potential for rare but serious adverse reactions, including Major Adverse Cardiovascular Events (MACE), such as non-fatal stroke or myocardial infarction, and Venous Thromboembolism (VTE), such as Deep Vein Thrombosis (DVT). The medicine is contraindicated in males with known or suspected prostate cancer or breast cancer. Furthermore, treatment requires the regular monitoring of PSA and hematocrit levels throughout therapy. Specific safety considerations apply to pediatric patients due to the risk of accelerated bone maturation, and to patients with pre-existing cardiac, renal, or hepatic disease due to the risk of significant edema.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Testosterone undecanoate (Andriol) outlines the documented manifestations and required emergency actions in the event of an overdose.


Documented Overdose Manifestations

Overdose exposure may result in an exaggeration of known androgen-related adverse reactions.

System Documented Signs in Overdose Context
Systemic Manifestations of excessive fluid retention (Oedema)
CNS Effects such as irritability and nervousness
GI Gastrointestinal disturbances

Required Emergency Actions

In the event of a known or suspected overdose, regulatory guidance mandates seeking immediate medical attention or contacting a poison control center.

  • Urgent Care Required: Immediate medical assistance must be sought if manifestations are severe or indicate a life-threatening risk. This includes signs that suggest the potential for congestive heart failure, particularly in individuals with pre-existing cardiac, renal, or hepatic impairment.
  • Management: Management is defined as the immediate discontinuation of the medication and the provision of symptomatic and supportive treatment.
  • Antidote Status: Regulatory documents explicitly state that no specific antidote is known for testosterone undecanoate overdose. Hospital monitoring may be required for the observation of vital and cardiovascular status.

Therapeutic Uses of Andriol

Main Uses of Andriol

Andriol is a medication used for testosterone replacement therapy in men who do not produce enough natural testosterone, a condition known as hypogonadism. The primary purpose of the treatment is to restore testosterone levels to a normal range, which helps address various physical and physiological symptoms associated with a deficiency.

Clinical Applications

The medication is typically indicated for the following conditions:

  • Primary Hypogonadism: This occurs when the testes are unable to produce sufficient testosterone due to injury, infection, or genetic factors.
  • Secondary Hypogonadism: This occurs when the pituitary gland or hypothalamus—the parts of the brain that signal the testes to produce testosterone—are not functioning correctly.

Benefits of Treatment

By elevating testosterone levels to a physiological baseline, Andriol helps mitigate the symptoms of androgen deficiency. The benefits of this stabilization can be observed across several areas of health:

Physical Health and Body Composition

Testosterone plays a crucial role in maintaining male physical characteristics. Treatment can lead to:

  • Increased Muscle Mass: Support for the development and maintenance of lean muscle tissue.
  • Bone Density Maintenance: Reduced risk of bone thinning or osteoporosis, as testosterone is vital for bone mineralization.
  • Metabolic Support: Potential improvements in fat distribution and energy metabolism.

Sexual Function

One of the hallmark signs of low testosterone is a decline in reproductive health. Normalizing these levels often leads to:

  • Improved Libido: An increase in sexual desire and interest.
  • Enhanced Sexual Function: Better management of erectile dysfunction when the cause is hormonal.

Psychological Well-being and Vitality

Low testosterone levels are frequently linked to mood disturbances and fatigue. Restoration of hormonal balance may result in:

  • Mood Stabilization: Reduction in irritability and symptoms of low mood.
  • Cognitive Support: Improved focus and mental clarity.
  • Increased Energy: A reduction in the persistent fatigue and lethargy often associated with hypogonadism.

Eligibility and Restrictions for Use

The eligibility profile for Andriol is defined by strict regulatory parameters. Use is restricted exclusively to adult males with a clinically confirmed diagnosis of either Primary or Hypogonadotropic Hypogonadism. The medicine is not established and not recommended for men with hypogonadism not associated with structural or genetic etiologies, such as non-specific age-related decline.

The medicine is absolutely contraindicated in men with known or suspected carcinoma of the breast or carcinoma of the prostate. Due to the risk of fetal virilization, it is also contraindicated in pregnant women and is not indicated for women generally.

Regarding age, use in children and adolescents (under 18 years) is not recommended as safety and efficacy are unestablished. Treatment in older adults requires caution due to limited data. Furthermore, patients with uncontrolled hypertension or severe cardiac, renal, or hepatic disease are either not recommended for treatment or require caution due to the risk of fluid retention.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Andriol (Testosterone undecanoate) as described in government regulatory labeling.

Pharmacodynamic and Contraindicated Interactions

Co-administration with Oxyphenbutazone is formally designated as a contraindicated combination. The medicine is documented to enhance the effects of certain drug classes, an outcome classified as a pharmacodynamic interaction. This includes increasing the anticoagulant effect of oral anticoagulants (e.g., warfarin) and enhancing the glucose-lowering effect of insulin and other antidiabetic agents. Furthermore, the combination with corticosteroids or ACTH is officially documented to increase the risk of oedema.

Pharmacokinetic Exposure Changes

The plasma concentration of testosterone is subject to pharmacokinetic interaction with agents that modulate hepatic enzymes. Co-administration with strong enzyme inhibitors (e.g., ketoconazole, clarithromycin, HIV protease inhibitors) is documented to increase testosterone exposure. Conversely, strong enzyme inducers (e.g., rifampicin, carbamazepine, phenytoin) are documented to reduce testosterone plasma concentrations.

Mandatory Food Requirement

The unique oral formulation requires the soft capsules to be administered with food. This is a mandatory administration condition necessary to ensure adequate systemic absorption of the active compound.

Mechanism of Action

Andriol (testosterone undecanoate) is an orally administered prodrug that undergoes rapid hydrolysis by esterases in the small intestine, releasing free testosterone. The lipophilic nature of the ester facilitates its absorption primarily into the lymphatic system, bypassing significant first-pass hepatic metabolism. This delivers intact testosterone into the systemic circulation.

Testosterone functions as a high-affinity agonist for the androgen receptor (AR), a nuclear receptor found in target cells throughout the body. Binding of testosterone to the AR induces a conformational change, leading to the receptor's dimerization and subsequent translocation into the cell nucleus. Within the nucleus, the activated receptor complex binds to specific DNA sequences known as Androgen Response Elements (AREs). This binding modulates gene transcription, which results in the upregulation or downregulation of key proteins that govern system-level anabolic and androgenic physiological modulation.

Dosage and Administration Information

How to Use Andriol (Testosterone Undecanoate)

The administration of Andriol (Testosterone undecanoate) is governed by specific procedural guidelines to ensure the correct systemic delivery of the oral androgen.


Administration Scope

Instruction Detail
Route of administration Oral administration in the form of a soft capsule.
Dosing schedule The standard regimen involves an initial daily dose of 120 mg to 160 mg for titration, followed by a lower maintenance dose, typically ranging from 40 mg to 120 mg daily.
Timing in relation to meals Doses must be consumed with a meal. Food intake is essential for facilitating the absorption of the oil-based capsule formulation via the lymphatic system.
Preparation requirements The soft capsules must be swallowed whole with water and should not be crushed, chewed, or opened.
Age-group administration rules For older adults, careful titration to the lowest effective maintenance dose is advised to manage testosterone levels.
Missed-dose rules If a dose is missed, it should be taken as soon as remembered with food, unless the next dose is due shortly, in which case the missed dose is skipped. Compensation with a double dose is not permitted.
Special procedural conditions Dose adjustments throughout the course of treatment are guided by the results of serum testosterone concentration monitoring.

Procedural Structure

The official usage protocol dictates a chronic, long-term pattern. The total daily dosage is administered in two equally divided doses, usually taken morning and evening. This schedule includes an initial period (typically 2 to 3 weeks) at the higher dose range before transitioning to a stable maintenance dose determined by procedural monitoring.

Recent Clinical Evidence

Research evidence / Overview of studies for Andriol

Evidence for Androgen Replacement Therapy in Male Hypogonadism

Research for this oral formulation of testosterone undecanoate was studied for use in adult hypogonadal males, a population defined by clinically confirmed testosterone deficiency. Research examined the evaluation of the medicine across several short-term Randomized Controlled Trials (RCTs), typically lasting around three to four months. The evidence derived from these settings focused primarily on assessing the measured levels of testosterone in relation to the normal physiological range.

Examining the Study Outcomes: Hormone Levels and Symptoms

The principal research goal of the pivotal trials was to measure the total testosterone concentration in the blood, following administration, to assess its presence within the prespecified normal range. Studies monitored this concentration closely and reported measurements that were consistently within the prespecified normal range during the defined time intervals of the short-term studies.

Research also explored how the symptoms of hypogonadism were monitored in the observed populations. This included outcomes related to sexual function, overall energy, and mood, which were often assessed using patient-reported outcomes describing perceived discomfort. Studies reported that changes were measured during the study period across these various symptom axes, and research provides insight into short-term changes in patient-reported experiences.

Research on Functional and Compositional Changes

Beyond hormone concentrations, studies monitored other physical outcomes reflecting daily functioning or activity level over the research period. Evidence was monitored for body composition, where research describes patterns such as trends toward increases in lean body mass and concurrent decreases in fat mass, particularly in studies of longer duration.

Research Gaps and Areas of Uncertainty

Certainty remains low regarding outcomes that were not the primary focus of the research. Findings were mixed or based on modest sample sizes for certain secondary measures. The overall evidence is limited by the fact that follow-up durations were limited, typically extending up to one or two years. Research does not provide insight into whether an individual’s response will continue similarly over many years of treatment, and long-term effects are not fully established regarding durability of symptom patterns.

Frequently Asked Questions (FAQ)

Common questions about Andriol (FAQ)


Q: How quickly does Andriol start to have an effect?

Official documents note that symptom changes may begin within a few days of initiating therapy. However, the full effect on hormone stabilization typically requires weeks to months of treatment. This general expectation comes from official product information and clinical summaries.


Q: How long can a person safely take Andriol?

Regulatory summaries indicate that data from clinical trials regarding the long-term safety and efficacy of Andriol for prolonged use (e.g., beyond one or two years) is limited. Due to this, the long-term effects of use extending over many years are not fully characterized in the available data, and continued use requires ongoing monitoring.


Q: Does Andriol require regular blood tests while using it?

Yes, official monitoring is required during treatment. This includes checking blood levels of serum testosterone to help guide the dosage. Furthermore, periodic blood tests for hematocrit (red blood cell volume) and Prostate-Specific Antigen (PSA) levels are typically required to monitor for certain potential side effects.


Q: How does the body process Andriol compared to injected testosterone?

Andriol is formulated as a soft capsule designed for a unique absorption route. The oral capsule facilitates absorption primarily through the lymphatic system to largely bypass immediate metabolism in the liver (first-pass effect). This lymphatic absorption is a distinguishing characteristic of this oral preparation.


Q: What kind of monitoring is typically done when a person is on Andriol?

The required monitoring throughout therapy includes checking serum testosterone concentrations to verify the therapeutic range. Additionally, regular monitoring of the prostate itself, PSA levels, and hematocrit (red blood cell volume) is necessary, as outlined in official product safety information.


Q: Does Andriol cause hair loss or thinning?

Official product information lists alopecia (hair loss) as a possible adverse reaction. This effect is categorized under the system-organ class for Skin and Subcutaneous Tissue Disorders in regulatory documentation.


Q: Can Andriol affect fertility or sperm count?

Official information indicates that the prolonged use of testosterone products can lead to the suppression of the hormones responsible for natural sperm production. The suppression of these hormones may result in oligospermia (a low sperm count) or decreased ejaculatory volume. These effects are generally described as reversible upon the cessation of the medicine.


Q: Will taking Andriol cause changes in my mood or aggression?

Regulatory documents list a category of potential adverse effects related to Psychiatric Disorders. These reported effects include emotional or mental health changes such as aggression, depression, anxiety, irritability, and general mood changes.


Q: Is Andriol considered a controlled substance?

Yes, in the United States, oral testosterone undecanoate (the active ingredient in Andriol) is legally classified as a Schedule III controlled substance. This regulatory classification acknowledges the medicine's potential for misuse.


Q: Can older men use Andriol safely?

Official guidelines specify that caution is warranted when Andriol is used in older adults due to limited clinical data in this population. It is noted that treatment for older adults often involves close monitoring and careful dose management.


Q: What official studies have been done on the long-term safety of Andriol?

Regulatory summaries indicate that data from long-term clinical trials for this product is generally limited, particularly for periods extending beyond one or two years of treatment. As a result, the full impact of use extending over many years is not fully characterized in the regulatory summaries.


Q: Can Andriol cause skin issues like acne?

Yes, official documentation lists acne as a recognized adverse reaction to this medicine. This skin issue is classified under the system-organ category for Skin and Subcutaneous Tissue Disorders.


Q: Are there any age restrictions for taking Andriol?

Yes, official labeling specifies an age restriction for this medicine. Use in males under 18 years of age is not indicated because the safety and effectiveness of the medicine have not been established in the pediatric patient population.


Q: Does Andriol have any effect on bone density?

Research related to testosterone replacement therapy in hypogonadal men has explored the medicine's impact on bone mineral density (BMD). Official research evidence summaries indicate that studies have monitored BMD changes over the course of the treatment period.


Q: What are the potential mental health side effects listed for Andriol?

The official documentation lists several potential side effects related to mental health under Psychiatric Disorders. These include emotional states such as depression, anxiety, confusion, and aggression, as well as a possible decreased libido.


Q: Why must Andriol be taken multiple times a day?

The official administration protocol requires the total daily dosage to be split and taken in two equally divided doses (e.g., morning and evening). This schedule is established based on pharmacokinetic principles to help ensure that serum testosterone levels are maintained within the normal physiological range throughout the entire 24-hour period.


Q: What is the half-life of Andriol in the body?

According to pharmacokinetic information, the elimination half-life of the testosterone undecanoate compound itself is typically reported to be around two hours. It is important to note that the half-life of the active testosterone molecule released from the compound may vary.

How should Andriol be stored and disposed of?

How to Store and Dispose of Andriol Testocaps

Official regulatory guidelines mandate specific conditions for the storage and disposal of Andriol Testocaps (testosterone undecanoate capsules).


Required Storage and Handling

The medicine must be stored at a temperature below 30 C (86 F). It is explicitly required that the capsules must not be refrigerated or frozen.

To ensure product stability, the capsules must remain in their original package (blister in the outer carton) to protect them from both light and moisture. Always keep the product out of the sight and reach of children.

Disposal Instructions

Do not use the capsules after the labeled expiry date. Unused or expired Andriol Testocaps must not be thrown into wastewater or household waste.

For proper disposal, the official instruction is to return the unused or expired medicine to a pharmacy or designated collection point for appropriate pharmaceutical waste handling.

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

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