85/100 · Critical
Manufactured by Pharmacia & Upjohn Company LLC
High Safety Concerns with Medroxyprogesterone Acetate, Particularly for Breast Cancer
57,188 FDA adverse event reports analyzed
Last updated: 2026-05-12
MEDROXYPROGESTERONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. Based on analysis of 57,188 FDA adverse event reports, MEDROXYPROGESTERONE ACETATE has a safety score of 85 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 MEDROXYPROGESTERONE ACETATE include BREAST CANCER FEMALE, BREAST CANCER, MENINGIOMA, BREAST CANCER METASTATIC, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MEDROXYPROGESTERONE ACETATE.
Medroxyprogesterone Acetate has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 57,188 adverse event reports for this medication, which is primarily manufactured by Pharmacia & Upjohn Company Llc.
The most commonly reported adverse events include Breast Cancer Female, Breast Cancer, Meningioma. Of classified reports, 85.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with breast cancer being the most frequently reported reaction.
A significant number of reports involve drug ineffectiveness and unintended pregnancy, indicating potential issues with efficacy. Safety signals include various neurological and gastrointestinal symptoms, as well as cardiovascular events.
Patients taking Medroxyprogesterone Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Medroxyprogesterone acetate can interact with other hormonal medications and may increase the risk of thrombotic events. Patients should be monitored for these interactions and symptoms. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Medroxyprogesterone Acetate received a safety concern score of 85/100 (high concern). This is based on a 85.2% serious event ratio across 39,194 classified reports. The score accounts for 57,188 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: Female: 36,934, Male: 343, Unknown: 84. The most frequently reported age groups are age 59 (470 reports), age 61 (465 reports), age 57 (451 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 39,194 classified reports for MEDROXYPROGESTERONE 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.
Medroxyprogesterone acetate can interact with other hormonal medications and may increase the risk of thrombotic events. Patients should be monitored for these interactions and symptoms.
If you are taking Medroxyprogesterone Acetate, here are important things to know. The most commonly reported side effects include breast cancer female, breast cancer, meningioma, breast cancer metastatic, drug ineffective. 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. Regular monitoring for breast cancer and other serious conditions is recommended. 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.
Regulatory oversight is ongoing, with the FDA requiring post-marketing surveillance to further evaluate the safety profile, especially regarding breast cancer risks.
The FDA has received approximately 57,188 adverse event reports associated with Medroxyprogesterone 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 Medroxyprogesterone Acetate include Breast Cancer Female, Breast Cancer, Meningioma, Breast Cancer Metastatic, Drug Ineffective. By volume, the top reported reactions are: Breast Cancer Female (9,773 reports), Breast Cancer (8,165 reports), Meningioma (1,680 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Medroxyprogesterone Acetate.
Out of 39,194 classified reports, 33,402 (85.2%) were classified as serious and 5,792 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 Medroxyprogesterone Acetate break down by patient sex as follows: Female: 36,934, Male: 343, Unknown: 84. 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 Medroxyprogesterone Acetate adverse events are: age 59: 470 reports, age 61: 465 reports, age 57: 451 reports, age 58: 449 reports, age 55: 437 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 Medroxyprogesterone Acetate adverse event reports is Pharmacia & Upjohn Company Llc. 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 Medroxyprogesterone Acetate include: Nausea, Headache, Pain, Depression, Fatigue. 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 Medroxyprogesterone 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.
Medroxyprogesterone Acetate has a safety concern score of 85 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. The majority of adverse events are serious, with breast cancer being the most frequently reported reaction.
Key safety signals identified in Medroxyprogesterone Acetate's adverse event data include: Breast cancer (both female and non-specific) is the most common serious adverse reaction.. Drug ineffectiveness and unintended pregnancy are notable signals of potential efficacy issues.. Neurological symptoms such as dizziness and anxiety are frequently reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Medroxyprogesterone acetate can interact with other hormonal medications and may increase the risk of thrombotic events. Patients should be monitored for these interactions and symptoms. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Medroxyprogesterone Acetate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for breast cancer and other serious conditions is recommended.
Medroxyprogesterone Acetate has 57,188 adverse event reports on file with the FDA. A significant number of reports involve drug ineffectiveness and unintended pregnancy, indicating potential issues with efficacy. The volume of reports for Medroxyprogesterone Acetate reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing surveillance to further evaluate the safety profile, especially regarding breast cancer risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Pharmacia & Upjohn Company LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with MEDROXYPROGESTERONE ACETATE:
Drugs related to MEDROXYPROGESTERONE ACETATE based on therapeutic use, drug class, or shared indications: