Androdex

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Androdex

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 Androdex

Property Description
Active ingredient Bicalutamide
Form Oral Tablet
Pharmacological Class Nonsteroidal Antiandrogen (NSAA)
Common Use Hormone therapy (to manage androgen-sensitive conditions)
Origin Synthetic

The Identity and Classification of Androdex

Androdex is a commercial trade name for a prescription-only medication containing the active component Bicalutamide. It is formally classified as a Nonsteroidal Antiandrogen (NSAA) and an Antineoplastic Agent, placing it within the therapeutic group of hormone therapy. The drug is a synthetic, single-ingredient product delivered as an oral tablet for systemic action.

Bicalutamide's classification as an NSAA defines its therapeutic role: it is designed to interfere with the activity of natural male hormones, or androgens, without possessing the steroid chemical structure. Bicalutamide is utilized to block the effects of androgens, a capability utilized for targeted hormonal management.


Composition, Origin, and General Purpose

The medication's effect is driven exclusively by the active substance Bicalutamide. As an Androgen Receptor Inhibitor, Bicalutamide is designed to bind to receptor sites on cells where male hormones, such as testosterone, would normally attach. This action is the basis for the drug's general purpose: to control the progression of conditions sensitive to male hormones. Androdex, as a brand, provides an oral formulation distinguished by its manufacturer's specific tablet design and high-purity Bicalutamide source.

Bicalutamide competitively inhibits the androgen receptor, thereby blocking the biological effects of androgens and providing a hormonal treatment effect. The drug’s primary function is derived from its ability to suppress hormonal encouragement for cell growth.

Regulatory References

  1. MedlinePlus Drug Information
  2. NIH LiverTox
  3. EMA Public Assessment Report

What side effects are possible with Androdex?

Possible Side Effects and Safety Information: Androdex (Bicalutamide)

The safety profile of Androdex (Bicalutamide) is classified by regulatory authorities based on the frequency and system-organ class (SOC) affected. The information below reflects adverse reactions and specific safety statements formally documented in official government regulatory labels.

Adverse Reaction Scope Official Regulatory Classification
Frequency Classification Very Common (ge 1/10): Hot flashes, asthenia, peripheral edema, pain, breast pain, and breast tenderness. Common (ge 1/100 to < 1/10): Anemia, dizziness, depression, abdominal pain, constipation, nausea, transaminase increases, alopecia, rash, hematuria, decreased libido, and impotence.
System-Organ Classes The most frequently involved SOCs include Vascular disorders (hot flashes), Reproductive system and breast disorders (gynecomastia, breast pain), General disorders (asthenia, edema), Gastrointestinal disorders (nausea, constipation), and Hepatobiliary disorders (transaminase increases).
Serious Adverse Reactions Regulatory documents note Hepatic failure as a rare but serious adverse reaction, requiring close monitoring of liver enzyme levels. Interstitial Lung Disease (including rare fatalities) and certain serious cardiovascular events are also documented as associated risks.
Population Constraints Use is contraindicated in women (including those who are or may become pregnant) and in children. Caution is specifically advised for patients with pre-existing cardiac risk factors and for those with moderate to severe hepatic impairment.
Safety Restrictions Use is contraindicated in individuals with known hypersensitivity. The product label notes the potential for interaction with coumarin-type anticoagulants, necessitating close monitoring of INR/Prothrombin Time if co-administered. Hepatic changes are generally expected to occur within the first six months of therapy, and severe changes necessitate discontinuation.

This structure establishes the formal regulatory boundaries for the medicine, detailing the expected common effects alongside the rare, serious events and the specific populations for which use is restricted or requires caution.

Overdose and Emergency Response

Overdose and When to Seek Help

The management of Bicalutamide (Androdex) overexposure is based strictly on procedures mandated in regulatory prescribing information. Any suspected ingestion of a quantity greater than prescribed requires seeking immediate medical attention.

Official Overdose Profile

Element Regulatory Statement
Documented Manifestations No specific symptoms or defining clinical signs of overdose have been formally documented in regulatory labeling due to limited clinical experience.
Life-Threatening Risk Overdose cases involving doses up to fifteen times the daily recommended dose have been reported without life-threatening symptoms.
Antidote Availability It is officially documented that no specific antidote is known for Bicalutamide overexposure.
Supportive Treatment Treatment must be symptomatic and supportive. Dialysis is not expected to be useful due to the drug’s high plasma protein binding.

Patient Monitoring and Considerations

General supportive care involves frequent monitoring of vital signs and continuous clinical observation. Vomiting should not be induced. The official label notes that elimination may be slower in patients with severe hepatic impairment, which could lead to increased accumulation following overexposure. The regulatory profile defines the required action for overexposure as immediate professional medical intervention.

Therapeutic Uses of Androdex

What Androdex Treats: Main Uses and Benefits

Androdex (Bicalutamide) may be part of symptomatic management in hormonal therapy focused on the management of androgen-sensitive prostate cancer. Its therapeutic application is applied in contexts involving the need to manage the underlying androgen-driven activity and address the severe symptomatic burden it imposes. The medication is indicated for use in advanced stages of the disease.

This therapy is applied in addressing the chronic and progressive nature of advanced disease, including locally advanced or metastatic prostate carcinoma, and is commonly used to manage the risk of acute symptom escalation when initiating combination treatments. It supports the management of disease activity linked to hormonal activity, which is relevant when supportive symptom management is appropriate for a long-term chronic condition.

Androdex is applied in addressing the significant symptoms that accompany advanced disease. It offers support by helping to reduce pain, particularly symptoms related to physical discomfort, and managing urinary difficulties caused by the tumor mass. This supports general well-being during symptomatic phases and stability for the patient.

“It supports the management of disease activity linked to hormonal changes and assists with maintaining functional stability when symptoms are more noticeable.”

Quick Fact: Supportive Management for Cancer-Related Discomfort


The medication helps address symptom clusters that may become intense or disruptive, such as skeletal pain and functional disturbances, contributing to easing the overall symptom load.

Eligibility and Restrictions for Use

The use of Androdex (Bicalutamide) is strictly limited to the adult male population and is defined by explicit regulatory contraindications and conditions requiring caution. Use is established in adult males, including the elderly, with no necessary adjustment for age or for patients with renal impairment.

Absolute Contraindications

Eligibility Status Population/Condition
Contraindicated Females, including those who are pregnant or breastfeeding
Children and adolescents (pediatric population)
Known hypersensitivity to Bicalutamide or any of the tablet components

Conditional Use and Restrictions

Official labeling advises that Bicalutamide must be used with caution in patients with moderate to severe hepatic impairment, as elimination may be delayed. Caution is also advised in patients with severe renal impairment due to limited clinical experience in this specific group.

Furthermore, individuals with rare hereditary problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine due to excipient content. Males with female partners of reproductive potential are advised to use effective contraception during and for a period following treatment.

What should I know about interactions with other medicines?

Androdex Interactions with other medicines and products

Androdex (methyltestosterone) can interact with several classes of medications, which may require dose adjustments or close monitoring by a healthcare provider. These interactions are primarily due to the hormonal effects of Androdex on metabolic processes.


Interacting Medicine Category Interaction Effect Monitoring/Action
Anticoagulants (e.g., Warfarin, Dicumarol) May increase the blood-thinning effects. Requires close monitoring of blood clotting tests (like PT/INR) and potential dose reduction of the anticoagulant.
Antidiabetic Agents (e.g., Insulin, Sulfonylureas) May decrease blood glucose levels, enhancing the effect of antidiabetic drugs. Requires careful monitoring of blood sugar and possible dose adjustment of the insulin or oral antidiabetic medicine.
Corticosteroids (e.g., Prednisone, Dexamethasone) May increase the risk of fluid retention and edema. Monitoring for signs of swelling is necessary, particularly in individuals with pre-existing heart, liver, or kidney conditions.
Cyclosporine May increase the blood levels of Cyclosporine. Requires monitoring of Cyclosporine levels and potential dose adjustment to avoid toxicity.

It is important to provide a comprehensive list of all prescription and non-prescription medicines, vitamins, and herbal products to your healthcare team to allow for a full assessment of potential interactions before beginning treatment with Androdex.

Mechanism of Action

The drug Bicalutamide (Androdex) functions through competitive silent antagonism at the Androgen Receptor (AR), a nuclear receptor that mediates the actions of male hormones. The drug's active (R)-enantiomer binds to the AR's ligand-binding domain, physically occupying the site and displacing natural androgens like Testosterone and Dihydrotestosterone (DHT). This molecular interaction prevents the receptor from transmitting the required signal into the cell. Consequently, the drug-receptor complex forms a transcriptionally inactive complex that fails to initiate the specific genetic sequence for cellular proliferation and survival. This direct inhibition of gene transcription interrupts the molecular signaling that drives androgen-dependent biological processes, leading to a systemic antiandrogenic effect. A secondary consequence of AR antagonism in the pituitary removes the negative feedback exerted on the Hypothalamic-Pituitary-Gonadal (HPG) axis, resulting in a compensatory increase in Luteinizing Hormone (LH) and circulating androgens. Despite the resulting elevated systemic hormone levels, the simultaneous peripheral antagonism acts to prevent the functional activation of target tissues by these hormones.

Dosage and Administration Information

How Androdex is Used: Official Administration Guidelines

Androdex (bicalutamide) is an oral tablet used on a continuous, daily basis as part of hormonal management.

The medication is available in two primary strengths, 50 mg and 150 mg, which correlate with different usage contexts. The official route of administration is strictly oral.


Dosage and Schedule

Administration is fixed at once daily and must be taken consistently at the same time each day, regardless of whether it is morning or evening, and may be taken with or without food.

  • 50 mg Regimen: The recommended dose is 50 mg once daily. When used for metastatic disease, treatment must be started concomitantly (at the same time) as therapy with a Luteinizing Hormone-Releasing Hormone (LHRH) analog.
  • 150 mg Regimen: The recommended dose is 150 mg once daily, used as monotherapy or as adjuvant therapy for locally advanced disease. This regimen is typically intended for continuous use for at least two years or until evidence of disease progression.

Procedural Constraints

Tablets should be swallowed whole with liquid. If a dose is missed, the patient must skip the missed dose and take the next prescribed dose at the usual scheduled time; the dose must not be doubled to make up for the omission.

Population-Specific Rules:

  • Renal Impairment: No dosage adjustment is necessary for any degree of renal impairment.
  • Hepatic Impairment: No dosage adjustment is required for mild to moderate hepatic impairment, though monitoring is advised in moderate to severe cases.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Androdex

Evidence for use in Chronic Insomnia

Research for the use of Androdex in chronic insomnia has focused primarily on controlled studies, known as short-term randomized clinical trials (RCTs). These studies were applied in populations of non-elderly adults. Outcomes monitored included objective measurements of the time it takes to fall asleep, as well as patient-reported outcomes describing perceived discomfort related to sleep maintenance and duration. Findings describe patterns observed in these studies.

What remains uncertain is the long-term characterization of these observed patterns; evidence for use beyond a few months is limited. Data for older adults or individuals with other co-existing medical conditions remain insufficient. Research is still exploring the patterns observed when use of the study product is stopped.


Evidence for use in Anxiety Associated with Depression

Studies were conducted on adult patients who had a diagnosis of major depressive disorder (MDD) and also experienced significant anxiety symptoms. The research explored how symptoms evolved over defined time intervals, usually 8 to 12 weeks, using standardized instruments designed to measure changes in both depressive and anxiety symptom severity. Research highlights changes measured in both depression- and anxiety-related severity scores. Studies reported patterns related to these measured changes.

The research exploring short-term symptom changes contributes to understanding symptom patterns in this patient group, but long-term functional outcomes are not fully established. Furthermore, there is limited information for patients whose primary diagnosis is an anxiety disorder, where depression is not the main feature.


Evidence in Special Populations and Uncertainty

The research populations primarily consisted of non-elderly adults without major co-morbid conditions. Consequently, data are still emerging and remain insufficient for certain groups, such as older adults (those 65 years and older) across all studied indications. Overall, the follow-up durations were limited across all indications, and comparative evidence is lacking in some research contexts.

Frequently Asked Questions (FAQ)

Common questions about Androdex (FAQ)

Q: How is Androdex different from [similar drug name]?

A: According to official drug classifications, Androdex is a Nonsteroidal Antiandrogen (NSAA). This type of medicine is designed to work by blocking the effects of male hormones in the body. Unlike steroid hormones, an NSAA achieves its effect without possessing a steroid chemical structure.

Q: Is it possible to take Androdex long-term?

A: The official product label describes the 150 mg regimen as typically intended for continuous use for at least two years. Official documents indicate the drug is intended for the long-term management of certain conditions. However, the available research studies focusing on long-term functional outcomes are noted as being limited.

Q: Can Androdex interact with birth control pills?

A: The regulatory label contains a precaution that males with female partners of reproductive potential should use effective contraception. This precaution is included because the medication may affect sperm, and this is advised during treatment and for 130 days after the last dose.

Q: What are the official clinical trial findings regarding Androdex?

A: The official label for the 50 mg dose states it is indicated for use in combination with a Luteinizing Hormone-Releasing Hormone (LHRH) analog. This regimen is used for the treatment of Stage D2 metastatic carcinoma of the prostate, based on clinical trial evidence.

Q: Is Androdex safe for people with high blood pressure?

A: Official documents describe specific advice for patients who have pre-existing cardiac risk factors. Additionally, when the drug is used alongside LHRH agonists, there can be an increased risk of cardiovascular disease.

Q: Can Androdex affect fertility?

A: The regulatory label specifies that the medication is noted to have the potential to impair a male's ability to father a child. This potential impairment is described in official documents as potentially being reversible.

Q: Is Androdex intended to be a cure or a management treatment?

A: Androdex is classified as a medicine for hormonal management and is used to control the progression of conditions sensitive to male hormones. Official documents do not describe the medication as a cure.

Q: Is Androdex used for anything besides the main approved condition?

A: The official label for Androdex only defines two specific approved regimens based on the stage of the condition. Use outside of these approved indications is not defined by the official prescribing information.

Q: Does Androdex need to build up in the system before I see effects?

A: Pharmacological studies describe that the active component of the drug, known as the R-enantiomer, accumulates in the body. Continuous daily use indicates that the concentration of the active component will increase approximately tenfold.

Q: Is Androdex safe to use with over-the-counter pain relievers?

A: Official patient guidance includes the recommendation to consult a healthcare team before combining the drug with over-the-counter pain relievers such as ibuprofen or aspirin. This is because these may increase the risk of bleeding in certain situations. Acetaminophen is often noted in patient guides as acceptable for mild aches.

Q: Can taking Androdex cause weight changes?

A: Authoritative drug information confirms that a change in weight may be experienced as a possible side effect. This includes both weight loss and weight gain.

Q: Is Androdex known to cause problems with sleep?

A: Drug information lists difficulty sleeping as a possible side effect. Somnolence, which is a state of strong desire for sleep or drowsiness, has also been reported.

Q: What happens if I stop taking Androdex suddenly?

A: The prescribing information describes that if a specific tumor marker (PSA) rises, a temporary stop may be considered by a physician. This is done to monitor the patient for a possible antiandrogen withdrawal response.

Q: Is Androdex considered a controlled substance?

A: Bicalutamide, the active ingredient in Androdex, is classified with no DEA schedule. This means it is not categorized as a controlled substance in the U.S.

Q: What if I experience a mild headache after starting Androdex?

A: Headache is described as a possible side effect in authoritative drug information.

Q: How long does Androdex stay in your system after the last use?

A: The active component of the drug, the R-enantiomer, has a half-life of approximately one week. This long half-life is a key characteristic that governs how long the medication remains in the system.

Q: Does Androdex have a generic version available?

A: The active ingredient, bicalutamide, is widely available as a generic medication. The original brand name for this compound is Casodex.

Q: Does Androdex interfere with alcohol consumption?

A: Official patient information mentions the importance of discussing the use of alcohol with a healthcare professional. Interactions may occur, and chronic alcohol abuse is listed as a risk factor for associated bone loss.

Q: Does Androdex interact with commonly prescribed anxiety medications?

A: The drug is described in regulatory documents as a moderate inhibitor of the CYP3A4 enzyme. This is a common pathway used to metabolize many other medicines, which means the potential for interaction exists due to this metabolic pathway.

Q: What does the package insert say about driving or operating machinery while on Androdex?

A: The product monograph states that somnolence (drowsiness) has been reported in patients. The document contains advice that individuals experiencing this symptom should observe caution when driving or operating machinery.

Q: Can Androdex be used alongside herbal remedies?

A: Authoritative patient information includes a general caution regarding the importance of informing the healthcare team about all products being taken. This includes all prescription, non-prescription, and herbal products.

How should Androdex be stored and disposed of?

How to Store and Dispose of Androdex?

The storage and disposal of Androdex (Bicalutamide) tablets must strictly follow official regulatory guidelines to maintain product stability and safety.

Storage Requirements

Condition Requirement
Temperature Store at controlled room temperature (e.g., 20^circ to 25 C) and keep from freezing.
Environment Protect from direct light, excess heat, and moisture
Packaging Store in the original container and keep the container tightly closed.
Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired tablets should be disposed of in accordance with local regulations, preferably through a community drug take-back program. Medicines should not be thrown away via wastewater. If a take-back program is unavailable, follow authorized governmental household disposal instructions, which require mixing the drug with an undesirable substance before discarding it in the trash.

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

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