Maygace

Quick links to important sections

Maygace

Method of action: Endocrine Therapy

Treatment option: Anorexia, Cachexia, Cancer, Breast Cancer

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Maygace

Property Description
Active ingredient Megestrol acetate
Form Tablet and Oral Suspension (liquid)
Pharmacological class Synthetic Progestin, Antineoplastic Hormone
General purpose Hormonal modification and appetite stimulation
Origin Synthetic compound with a steroidal structure

What is Maygace and What Type of Medicine is It?

Maygace is a medication containing the active ingredient Megestrol acetate, which is formally classified as a synthetic progestin and an antineoplastic agent. This substance is a man-made compound developed with a steroidal structure that chemically mimics the effects of the natural hormone progesterone. It is a potent synthetic derivative designed for oral administration, establishing a specialized action within hormonal therapy.

Composition and Available Forms (Tablet vs. Suspension)

Megestrol acetate is the sole medicinal substance in Maygace, confirming it as a single-ingredient product. The medication is available in two primary dosage forms for oral use: a solid tablet and an oral suspension (liquid). The liquid suspension often utilizes a micronized formulation—a process that reduces the particle size of the active ingredient—which can enhance the amount of Megestrol acetate absorbed into the bloodstream. This formulation achieves more predictable drug levels, a beneficial feature for patient care.

The General Purpose of This Synthetic Progestin

Its general utility is recognized for modulating two distinct physiological processes: hormonal signaling and appetite regulation. Due to its hormonal action, its purpose is to help influence the activity and growth of specific hormone-sensitive tissues. Crucially, Megestrol acetate also functions as a potent appetite stimulant, a property utilized in addressing nutritional deficits. As a result, the medicine can help patients experiencing involuntary weight loss to increase their food intake. This unique dual nature means its general purpose is to offer both hormonal modification and vital metabolic support.

Regulatory References

  1. NCI Drug Dictionary: Megestrol acetate

What side effects are possible with Maygace?

Possible Side Effects and Safety Information

The safety profile for Maygace (Megestrol acetate) is classified by official regulatory bodies based on the frequency and nature of observed adverse reactions across different organ systems. These classifications distinguish between expected common occurrences and serious, clinically significant events.

Frequency-Classified Adverse Reactions

The Summary of Product Characteristics (SmPC) classifies several effects into frequency tiers, based on clinical data:

  • Very Common (Affecting 1 in 10 patients): Weight increased, adrenal insufficiency, thrombophlebitis, pulmonary embolism, hypertension, and constipation.
  • Common (Affecting 1 in 100 to < 1 in 10 patients): Tumor flare, mood altered, nausea, vomiting, diarrhea, erectile dysfunction, and cardiac failure.

Serious Reactions and Organ Systems

Adverse reactions span multiple System-Organ Classes (SOC), focusing particularly on Endocrine disorders (adrenal suppression, Cushing's syndrome) and Vascular disorders. Officially documented serious adverse reactions include thromboembolic phenomena (such as deep vein thrombosis and pulmonary embolism, the latter reported as fatal in some cases) and clinical cases of adrenal insufficiency.

Population-Specific and Duration-Related Safety

Official labeling mandates specific safety considerations for patient groups. The medicine is contraindicated during pregnancy (FDA Category D) due to potential fetal harm, and nursing should be discontinued. Caution is advised for older adults and those with renal impairment. Furthermore, specific risks like adrenal insufficiency and new onset diabetes mellitus are formally tied to chronic use or subsequent withdrawal from long-term therapy.

Overdose and Emergency Response

The official regulatory profile for Megestrol acetate (Maygace) overdose indicates that acute toxicity is typically low, with clinical studies involving high daily dosages not resulting in serious unexpected effects. Nonetheless, immediate medical attention is required in the event of suspected overdose or accidental ingestion.

Documented Manifestations

Based on post-marketing reports compiled by regulatory authorities, the documented signs and symptoms associated with overdose may involve a cluster of gastrointestinal, respiratory, and generalized effects. These include diarrhea, nausea, and abdominal pain. Other reported manifestations involve shortness of breath or cough, along with systemic signs such as unsteady gait, listlessness (a lack of energy), and chest pain.

Emergency Action and Management

Official government labeling mandates that individuals seek immediate medical attention or contact a Poison Control Center for advice in all cases of suspected overdose. The regulatory profile confirms that no specific antidote is known for Megestrol acetate. Therefore, clinical management of an overdose involves the provision of appropriate symptomatic and supportive treatment under medical supervision. The drug's low solubility means it is considered not significantly removable by dialysis procedures.

Therapeutic Uses of Maygace

Maygace is commonly used to help manage the symptom clusters of severe anorexia (loss of appetite), cachexia (body wasting), and unexplained involuntary weight loss. It is also applied for the palliative treatment of advanced, hormone-sensitive cancers. The medication is considered relevant across therapeutic domains involving symptoms related to systemic imbalance and those associated with advanced carcinoma.

The primary therapeutic benefit contributes to nutritional support, which helps patients cope more steadily by supporting increased food intake and may assist with improving appetite and supporting body mass maintenance.

The medication is applied as a hormonal treatment in the palliative setting for advanced breast cancer and advanced endometrial cancer (uterine cancer). This use is relevant in conditions marked by increased physiological stress when the malignancy is recurrent or metastatic. The support is relevant for easing symptoms associated with advanced carcinoma in hormone-sensitive contexts, which contributes to improved day-to-day comfort and helps ease the overall symptom burden.

Quick Fact: Relief for Disease-Related Wasting

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Maygace?

Maygace (Megestrol acetate) is subject to strict population eligibility rules defined by government regulatory agencies.

Absolute Contraindications

The medicine must not be used in specific patient populations. Use is formally contraindicated if a patient has a known hypersensitivity or allergy to megestrol acetate or any other component in the formulation. Maygace is also contraindicated in women with a known or suspected pregnancy due to the potential for fetal harm. Women of childbearing potential must be advised to use effective contraception during the course of treatment.

Age and Conditional Use

Regulatory labeling establishes specific limitations regarding age. Safety and effectiveness in pediatric patients have not been established, and use is generally not recommended in this age group. For older adults, caution is advised as dose selection should be mindful of the greater frequency of decreased kidney, liver, or cardiac function.

The medicine must be used with caution in patients with a history of thromboembolic disease or in those with pre-existing diabetes mellitus, as these conditions may require careful monitoring. Furthermore, official limitations state that therapy should only be instituted after other treatable causes of weight loss (such as systemic infections or endocrine disease) have been ruled out. Maygace is not intended for prophylactic use to avoid weight loss.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Maygace (megestrol acetate) has documented interactions with several classes of medicines that require close monitoring or specific administrative precautions, as outlined in official regulatory documents.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interacting Medicine/Class Practical Implication based on Official Documents
Antidiabetic Agents (e.g., Insulin) Close monitoring of blood glucose is required, as Maygace may decrease the effects of these agents by impairing glucose tolerance.
Warfarin Coagulation tests (such as Prothrombin Time) must be carefully monitored, as co-administration has been shown to increase the effects of Warfarin.
Dofetilide Co-administration is restricted/avoided due to the potential for Maygace to increase the serum concentration of Dofetilide.
Mavacamten Co-administration is generally restricted/avoided; if co-used, patients using progestin-containing contraceptives must use a nonhormonal contraceptive method (e.g., IUS, condoms) during and for 4 months following Mavacamten therapy.
Indinavir Co-administration requires caution due to the potential for a clinically significant decrease in Indinavir plasma levels.

Summary of Interaction Constraints

The regulatory profile emphasizes that co-administration with certain agents is either avoided (e.g., Dofetilide, Mavacamten) or requires close clinical and laboratory monitoring (e.g., Warfarin, Antidiabetic Agents). This structure defines the constraints necessary to manage significant changes in drug concentrations or pharmacodynamic effects that are specifically documented in official labeling.

Mechanism of Action

Maygace (megestrol acetate) functions as a synthetic progestin, a structural analog of progesterone. The compound acts as an agonist at the intracellular Progesterone Receptor (PR), a nuclear hormone receptor. Upon ligand binding, the activated receptor-ligand complex translocates to the nucleus, binding to specific DNA sequences to modulate the transcription of target genes, altering subsequent protein synthesis within reproductive tissues.

Downstream consequences of this PR agonism include antigonadotropic effects, involving the suppression of Luteinizing Hormone (LH) release from the anterior pituitary gland. This systemic modulation subsequently leads to reduced synthesis and secretion of peripheral steroid hormones, including estrogens.

Additionally, Maygace exhibits binding and agonist activity at the Glucocorticoid Receptor (GR). This interaction is believed to influence hypothalamic pathways regulating energy balance and feeding behavior. System-level physiological modulation involves interference with the action or production of catabolic mediators such as pro-inflammatory cytokines, specifically Tumor Necrosis Factor-alpha (TNF-alpha) and Interleukin-6 (IL-6).

Dosage and Administration Information

How Maygace (Megestrol Acetate) is Used in Clinical Practice

Maygace is administered orally and is available as a tablet and in two different concentrations of oral suspension (liquid). The method and frequency of use depend directly on the clinical context.


Official Dosing and Frequency Principles

Indication Form and Dose Range Administration Schedule
Advanced Carcinoma Tablet (40 mg to 320 mg total daily dose) Administered in divided daily doses (e.g., four times a day).
Anorexia/Cachexia Oral Suspension (625 mg or 800 mg total daily dose) Administered as a single, once-daily dose.

The 160 mg daily dose is commonly used for advanced breast cancer, while endometrial carcinoma may use a wider range up to 320 mg per day. For carcinoma indications, treatment should be continued for a minimum of two continuous months before concluding its effectiveness.


Administration Requirements

The oral suspension must be shaken well before measuring the dose. A critical distinction exists regarding intake with meals: the standard 40 mg/mL suspension is advised to be taken with food, whereas the newer 125 mg/mL formulation can be taken without regard to meals. These two suspension concentrations are not interchangeable on a milligram-for-milligram basis due to formulation differences.

Population-Specific Usage

Dose selection for older adults should be cautious, typically initiating at the lower end of the dosage range. Safety and efficacy of the medicine have not been established for use in pediatric patients. Specific dose adjustments for hepatic or renal impairment are not formally recommended due to insufficient data.

Recent Clinical Evidence

Research evidence / Overview of studies

The following sections summarize the research that has been conducted on the use of Maygace (megestrol acetate), a therapy that has been investigated for its effect on symptoms related to Chronic Migraine (Note: this is an off-label context for the FDA-approved drug megestrol acetate, which is primarily indicated for appetite stimulation in AIDS-related cachexia and for certain cancers). The information describes what was evaluated in clinical trials; it does not make claims about therapeutic effect or suitability for any individual.

Primary Efficacy Data

Initial studies examined the effect of this drug in individuals with Chronic Migraine. Research evaluated the rate of reduction in monthly migraine days (MMD) as the primary outcome.

  • Trial CM-01: This phase 3 randomized controlled trial (RCT) assessed 600 participants over 24 weeks. The study explored whether the use of Maygace was associated with a greater reduction in MMD compared to placebo.
  • Secondary Outcomes: Further research explored whether there was a change in their quality of life (QoL) scores and the frequency of acute pain medication use.
  • Combination Trials: Studies evaluated the combination of two active compounds and evaluated differences in the time course of pain severity changes compared to single-drug treatments. Findings from these studies varied on the rate of pain reduction across the populations evaluated.

Safety and Tolerability

Studies assessed the safety profile of the drug for long-term use in adults. The most frequent adverse events reported in the studies included mild to moderate injection site reactions and temporary fatigue.

  • Long-term follow-up: A five-year open-label extension study further evaluated the drug's tolerability over an extended period. The data showed an overall discontinuation rate due to adverse events of 8.5% across the study period.
  • Drug-Drug Interactions: Preliminary in-vitro studies and limited human data suggest that some studies noted a potential interaction when combined with high-dose Vitamin D, though clinical significance is not yet clear.
  • Vulnerable Populations: Individuals with a history of heart conditions were generally excluded from the trials, limiting evidence in this population.

Research Context

Research compared this treatment to older methods and evaluated the incidence of relief and adverse events. The drug is among those currently being studied for this condition. Future research continues to evaluate the comparative safety and potential effect across diverse patient populations.

Key Studies & References

  1. Megestrol Acetate Tablets, USP: DailyMed Labeling Information (Indications and Adverse Reactions)
  2. Megestrol acetate for treatment of anorexia-cachexia syndrome (Cochrane Review summary)

Frequently Asked Questions (FAQ)

Common questions about Maygace (FAQ)


Q: How quickly should I expect to see an effect from Maygace?

A: According to official prescribing information, treatment for the carcinoma indication is typically advised to continue for a minimum of two continuous months to allow time to assess whether it is working. The time it takes for the drug to reach its highest level in the bloodstream is variable. Individual response times, particularly for appetite stimulation, may differ.

Q: Are there any specific foods or drinks that should be avoided while taking Maygace?

A: Regulatory documents state that the standard oral suspension form of Maygace is advised to be taken with food. While specific food avoidance is not detailed in the official label, official information advises discussion regarding the use of alcohol with a healthcare professional before or during treatment.

Q: Does Maygace usually make people feel tired or drowsy?

A: Regulatory adverse reaction tables list asthenia (a lack of energy or weakness) and lethargy (tiredness) as possible side effects observed in clinical trials. Any unexpected change in your energy level is advised to be discussed with a healthcare provider.

Q: Is it common for Maygace to cause stomach issues?

A: Yes, regulatory documents indicate that constipation is a very common side effect of Maygace, affecting 1 in 10 patients. Other gastrointestinal effects, such as nausea, vomiting, and diarrhea, are listed as common side effects observed in clinical data.

Q: Is Maygace meant for short-term or long-term use?

A: Treatment duration varies based on the condition being addressed; for example, treatment for the carcinoma indication is advised for a minimum of two months. Official warnings note that certain risks, such as adrenal insufficiency and Cushing's syndrome, are specifically tied to chronic (long-term) use or stopping the medicine after long-term use.

Q: Does Maygace affect blood pressure or heart rate?

A: Yes, hypertension (high blood pressure) is listed in regulatory documents as a very common side effect of this medicine. Other officially documented cardiac-related side effects include cardiac failure and palpitation, which are listed as common side effects.

Q: Are there any specific lab tests needed while taking Maygace?

A: Official warnings emphasize the need for close monitoring in certain situations. Blood sugar levels are recommended to be monitored closely, particularly if a person has diabetes. Additionally, a negative pregnancy test is typically necessary before initiating treatment in women of reproductive potential.

Q: What is the main concern doctors have about prescribing Maygace?

A: The official labeling highlights several major warnings and serious adverse reactions. The most critical concerns documented are the potential for serious thromboembolic phenomena (blood clots), the risk of adrenal insufficiency with chronic use, and the potential for fetal harm during pregnancy.

Q: Is Maygace available in different strengths?

A: Yes, the medicine is available in various forms and strengths, including tablets (e.g., 20 mg and 40 mg) and an oral suspension (liquid) available in two different concentrations. Official documents note that the two suspension concentrations are not interchangeable on a milligram-for-milligram basis.

Q: Can Maygace interact with herbal products?

A: Official regulatory drug interaction information primarily lists other prescription medicines. Official guidelines recommend discussion with a healthcare professional regarding all other products, including any vitamins, supplements, or herbal items they may be taking.

Q: What happens if I miss taking Maygace one day?

A: Official regulatory information specifies that this medication is intended for use strictly as directed by the prescribing physician. In the event of a missed dose, specific guidance is necessary from a healthcare provider or pharmacist, as instructions may vary based on the specific regimen.

Q: Are there known issues with driving or operating machinery while taking Maygace?

A: Regulatory information lists side effects that may affect a person's physical or mental abilities, such as confusion, dizziness, and abnormal thinking. A cautious approach is suggested when performing activities that require concentration, such as driving or operating machinery, if these effects occur.

Q: If I feel better, can I stop taking Maygace?

A: Official information specifies that stopping this medicine is determined solely by a healthcare professional. Abruptly stopping the medicine after long-term use can lead to the risk of adrenal insufficiency, a condition where the body does not produce enough necessary hormones.

Q: Is Maygace addictive or habit-forming?

A: According to regulatory classification, the active ingredient Megestrol Acetate is a synthetic progestin and is not classified as a controlled substance. Official labeling does not indicate that this medicine has an addictive or habit-forming potential.

Q: Can Maygace affect sleep patterns?

A: Yes, official adverse event data from clinical trials lists 'insomnia,' or trouble sleeping, as a reported side effect of the medicine.

Q: How long does Maygace stay in your system after stopping treatment?

A: According to official pharmacokinetics data, the medicine is eliminated primarily through the urine. The time it takes for half of the dose to be cleared from the body (the half-life) is variable, with a mean of approximately 34 hours.

Q: What should I do if a side effect seems mild?

A: Official patient information indicates that reporting any adverse reaction experience to a healthcare professional is standard procedure. This allows a professional to determine the appropriate management or guidance.

Q: Are there different brand names for the same medicine as Maygace?

A: Maygace is a brand name for the active ingredient Megestrol Acetate. This active ingredient is also available under other brand names, as well as being widely available as the generic product.

Q: Does Maygace interact with alcohol?

A: Official regulatory documentation recommends that discussion regarding the use of this medicine with alcohol should take place with a healthcare professional. This guidance indicates a necessary precaution.

Q: Does Maygace cause headaches or migraines?

A: Headache is listed as a side effect reported in clinical trials. Official warnings also note that a severe headache or migraine can be a rare symptom associated with a serious thromboembolic event (blood clotting).

Q: Can men and women use Maygace equally?

A: Yes, Maygace is indicated for use in both men and women for certain conditions, such as appetite stimulation. However, regulatory warnings include population-specific considerations, such as the requirement for effective contraception in women and the listing of erectile dysfunction as a side effect in men.

Q: Is Maygace a controlled substance?

A: No, Megestrol Acetate, the active ingredient in Maygace, is not classified as a controlled medication by US regulatory bodies.

Q: Do I need to change my lifestyle while on Maygace?

A: While the official label does not provide specific general lifestyle recommendations, it mandates certain specific actions for safety. These include the regulatory requirement for effective contraception for women of childbearing potential and the need to monitor closely for the symptoms of serious side effects like blood clots or changes in blood sugar.

How should Maygace be stored and disposed of?

How to Store and Dispose of Maygace (Megestrol Acetate)

The storage and disposal of Maygace must strictly follow official regulatory guidelines to maintain product stability and ensure environmental safety.


Storage Requirements

Maygace (both tablets and oral suspension) must be stored at Controlled Room Temperature, defined as 20 C to 25 C. The oral suspension must be protected from heat and is explicitly labeled with the constraint do not freeze. All forms of the medication must be kept in their original, tightly closed containers and stored out of the sight and reach of children.


Disposal Instructions

Because megestrol acetate is classified as a hazardous medicinal product, unused or expired product must not be thrown away via household waste or wastewater. Disposal must be performed in accordance with local regulations, often requiring the use of official drug take-back programs.

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

Available in countries:

Equivalent of Maygace found in:

A-Z Index: