pharmacopeia
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/api/v1/drug/megestrol

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Estrogen Receptor Antagonists; Progestational Hormone Receptor Agonists.

Estrogen ReceptorProgestational Hormone Receptor

Indications

Sourced from openFDA
  • 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).

Contraindications

Sourced from openFDA
  • History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.contraindicated

Dosage & administration

Sourced from openFDA

The recommended adult initial dosage of megestrol acetate oral suspension, USP is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

Warnings & precautions

Sourced from openFDA

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. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.) 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 In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state.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.

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

No serious unexpected side effects have resulted from studies involving megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with megestrol acetate oral suspension. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability, however, due to its low solubility it is postulated that dialysis would not be an effective means of treating overdose

Approval history

Sourced from openFDA
  • Aug 8, 1988ANDAANDA072422Strides Pharma Intl
  • Aug 8, 1988ANDAANDA072423Strides Pharma Intl
  • Nov 30, 1995ANDAANDA074621Barr
  • Jul 25, 2001ANDAANDA075671Strides Pharma Intl
  • Nov 1, 2004ANDAANDA076721Pharmobedient
  • Feb 16, 2006ANDAANDA077404Novitium Pharma
  • Aug 27, 2014ANDAANDA203139Twi Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,789 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Death39811%
  2. 2Fatigue3479.2%
  3. 3Diarrhoea3449.1%
  4. 4Decreased Appetite2737.2%
  5. 5Asthenia2687.1%
  6. 6Nausea2616.9%
  7. 7Pneumonia2446.4%
  8. 8Dyspnoea2235.9%
  9. 9Weight Decreased1915.0%
  10. 10Vomiting1814.8%
  11. 11Off Label Use1804.8%
  12. 12Anaemia1684.4%
  13. 13Dehydration1594.2%
  14. 14Pain1483.9%
  15. 15Fall1433.8%

Literature

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Recent PubMed references pinned to Megestrol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 124 ClinicalTrials.gov registrations naming Megestrol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Megestrol work?
Mechanism-of-action classes: Estrogen Receptor Antagonists; Progestational Hormone Receptor Agonists.
What is Megestrol used for?
According to FDA labeling, Megestrol carries indications including: 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Megestrol?
Megestrol is classified as Pregnadien derivatives, Progestogens, Progestin, Estrogen Receptor Antagonists, Progestational Hormone Receptor Agonists, Appetite Stimulation, Decreased Luteinizing Hormone Secretion.
What are the contraindications for Megestrol?
Megestrol labeling lists contraindications including: History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.. Always consult the full prescribing information and a clinician.
Note. Data for megestrol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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