Megestrol: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 23, 2025

Megestrol

Active ingredient · 3 therapeutic classes

US FDAGB MHRACA Health Canada

Drug class: Progestogens
Availability: Prescription only
Routes: Oral
Markets covered: 3
Products on record: 6

G03ACProgestogens G03DBPregnadien Derivatives L02ABProgestogens

Overview

Plain-language summary, compiled from the cited regulatory records

Megestrol acetate is a progestogen [1]. It is approved for the treatment of anorexia, cachexia, or unexplained significant weight loss in patients diagnosed with acquired immunodeficiency syndrome (AIDS) [1].

This medication is available under various brand names [1].

This is not medical advice. Consult a qualified healthcare professional.

Regulatory status by market

Market	Regulator	Products	Last revision
US United States	FDA	1	May 23, 2025
GB United Kingdom	MHRA	1	January 24, 2025
CA Canada	Health Canada	4	March 22, 2025

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised May 23, 2025[1]

INDICATIONS AND USAGE
Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

How to take

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised January 24, 2025[2]

Megace is a progestational agent, indicated for the treatment of certain hormone dependent neoplasms, such as breast cancer.

How to take

CACanada· Health Canada

4 products

4 products on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].

Sources & citations

[1]FDA DailyMed · 01119031-9943-4a… · revised May 23, 2025 [PDF]
[2]MHRA (UK) · PL526370009 · revised January 24, 2025
[3]Health Canada (DPD) · 02185415 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

USOfficial regulatory label· Adverse reactions· revised May 23, 2025[1]

ADVERSE REACTIONS
Clinical Adverse Events:
Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks.
These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. ADVERSE EVENTS% of Patients Reporting Trial 1 (N = 236) Trail 2 (N=87) Open Label Trial Megestrol Acetate mg/day No. of Patients Placebo 0 N=34 100 N=68 400 N=69 800 N=65 Placebo 0 N=38 800 N=49 1200 N=176 Diarrhea 15 13 8 15 8 6 10 Impotence 3 4 6 14 0 4 7 Rash 9 9 4 12 3 2 6 Flatulence 9 0 1 9 3 10 6 Hypertension 0 0 0 8 0 0 4 Asthenia 3 2 3 6 8 4 5 Insomnia 0 3 4 6 0 0 1 Nausea 9 4 0 5 3 4 5 Anemia 6 3 3 5 0 0 0 Fever 3 6 4 5 3 2 1 Libido Decreased 3 4 0 5 0 2 1 Dyspepsia 0 0 3 3 5 4 2 Hyperglycemia 3 0 6 3 0 0 3 Headache 6 10 1 3 3 0 3 Pain 6 0 0 2 5 6 4 Vomiting 9 3 0 2 3 6 4 Pneumonia 6 0 2 2 3 0 1 Urinary Frequency 0 0 1 2 5 2 1 Adverse events which occurred in 1 to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system.
Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo. Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System - cardiomyopathy and palpitation Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System - leukopenia Metabolic and Nutritional - LDH increased, edema and peripheral edema Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System - dyspnea, cough, pharyngitis and lung disorder Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses - amblyopia Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing - Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS ).
To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. gov/medwatch.

USOfficial regulatory label· Warnings and precautions· revised May 23, 2025[1]

WARNINGS
Megestrol acetate may cause fetal harm when administered to a pregnant woman.
For animal data on fetal effects, (see PRECAUTIONS:
Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility ). There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus.
Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. ) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state.
Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealedthe frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. , hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state.
Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death.
, surgery, infection).

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised January 24, 2025[2]

The main side-effect experienced by patients while taking megestrol acetate, particularly at high doses, is weight gain, which is usually not associated with water retention, but which is secondary to an increased appetite and food intake.
Weight gain is associated with an increase in fat and body cell mass. Constipation and urinary frequency have also been reported in patients who received high doses of megestrol acetate in clinical trials. A rarely encountered side effect of prolonged administration of megestrol acetate is urticaria, presumably an idiosyncratic reaction to the drug.
The drug is devoid of the myelosuppressive activity characteristic of many cytotoxic drugs and it causes no significant changes in haematology, blood chemistry or urinalysis. Pituitary adrenal axis abnormalities including glucose intolerance, new onset diabetes, exacerbation of pre-existing diabetes with decreased glucose tolerance and Cushing’s syndrome have been reported with the use of megestrol acetate.
Clinically apparent adrenal insufficiency has been rarely reported in patients shortly after discontinuing megestrol acetate. The possibility of adrenal suppression should be considered in all patients taking or withdrawing from chronic megestrol acetate therapy.
Replacement stress doses of glucocorticoids may be indicated. The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, < 1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (< 1/10000), and not known (cannot be estimated from the available data).
System Organ Class Frequency MedDRA Term Neoplasms benign, malignant, and unspecified (including cysts and polyps) Common Tumour flare # Endocrine disorders Very common Adrenal insufficiency, cushingoid, Cushing’s syndrome Metabolism and nutrition disorders Very common Diabetes mellitus, glucose tolerance impaired, hyperglycaemia, increased appetite Psychiatric disorders Common Mood altered Nervous system disorders Common Carpal tunnel syndrome, lethargy Cardiac disorders Common Cardiac failure Vascular disorders Very common Thrombophlebitis, pulmonary embolism*, hypertension, hot flush Respiratory, Very Dyspnoea † Source of frequencies: Megestrol Acetate Oral, Corporate Product Labeling Profile (CPLP) dated 12 November 1996.
#with or without hypercalcemia * Pulmonary embolism (in some cases fatal) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised January 24, 2025[2]

Precautions:
Megace should be used with caution in patients with a history of thrombophlebitis and in patients with severe impaired liver function. This product should be used under the supervision of a specialist and the patients kept under regular surveillance.
This product can exert adrenocortical effects. This should be borne in mind in patient surveillance. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Insufficient data from clinical studies of megesterol acetate are available for patients 65 years of age and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.
In general, use in elderly patients should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
Because elderly patients are more likely to have decreased renal function, care should be taken during treatment with megestrol acetate, and it may be useful to monitor renal function.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

USUnited States· FDA

GBUnited Kingdom· MHRA

CACanada· Health Canada

Drugs in the same class

Sources & citations