82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Safety Concerns with Megestrol Acetate, Particularly for Serious Reactions
8,546 FDA adverse event reports analyzed
Last updated: 2026-05-12
MEGESTROL ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 8,546 FDA adverse event reports, MEGESTROL ACETATE has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for MEGESTROL ACETATE include DEATH, FATIGUE, DIARRHOEA, DECREASED APPETITE, ASTHENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MEGESTROL ACETATE.
Megestrol Acetate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 8,546 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Death, Fatigue, Diarrhoea. Of classified reports, 79.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage (79.9%) of reported reactions are serious, indicating significant safety concerns.
The most common reactions include death, pneumonia, and weight decreased, suggesting potential life-threatening risks. Report volume is substantial, with over 8,500 reports, providing a broad safety profile.
Patients taking Megestrol Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Megestrol Acetate may interact with other drugs, leading to adverse effects such as thrombosis and hematological issues. Patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Megestrol Acetate received a safety concern score of 82/100 (high concern). This is based on a 79.9% serious event ratio across 3,746 classified reports. The score accounts for 8,546 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 1,885, Female: 1,602, Unknown: 14. The most frequently reported age groups are age 73 (98 reports), age 68 (86 reports), age 71 (84 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,746 classified reports for MEGESTROL ACETATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Megestrol Acetate may interact with other drugs, leading to adverse effects such as thrombosis and hematological issues. Patients should inform their healthcare provider of all medications they are taking.
If you are taking Megestrol Acetate, here are important things to know. The most commonly reported side effects include death, fatigue, diarrhoea, decreased appetite, asthenia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and dose errors. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Megestrol Acetate due to its high number of serious adverse events. Healthcare providers should be vigilant and report any adverse reactions promptly.
The FDA has received approximately 8,546 adverse event reports associated with Megestrol Acetate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Megestrol Acetate include Death, Fatigue, Diarrhoea, Decreased Appetite, Asthenia. By volume, the top reported reactions are: Death (396 reports), Fatigue (343 reports), Diarrhoea (339 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Megestrol Acetate.
Out of 3,746 classified reports, 2,993 (79.9%) were classified as serious and 753 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Megestrol Acetate break down by patient sex as follows: Male: 1,885, Female: 1,602, Unknown: 14. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Megestrol Acetate adverse events are: age 73: 98 reports, age 68: 86 reports, age 71: 84 reports, age 67: 80 reports, age 69: 77 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Megestrol Acetate adverse event reports is Ani Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Megestrol Acetate include: Nausea, Pneumonia, Dyspnoea, Weight Decreased, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Megestrol Acetate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Megestrol Acetate has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. A high percentage (79.9%) of reported reactions are serious, indicating significant safety concerns.
Key safety signals identified in Megestrol Acetate's adverse event data include: Death is the most frequent serious reaction, with 396 reports.. Pneumonia and weight decreased are also highly reported, with 242 and 190 reports respectively.. There is a notable presence of hematological and respiratory issues, including anemia, neutropenia, and pulmonary embolism.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Megestrol Acetate may interact with other drugs, leading to adverse effects such as thrombosis and hematological issues. Patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Megestrol Acetate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions carefully to avoid drug interactions and dose errors.
Megestrol Acetate has 8,546 adverse event reports on file with the FDA. The most common reactions include death, pneumonia, and weight decreased, suggesting potential life-threatening risks. The volume of reports for Megestrol Acetate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Megestrol Acetate due to its high number of serious adverse events. Healthcare providers should be vigilant and report any adverse reactions promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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