60/100 · Moderate
Manufactured by ANI Pharmaceuticals, Inc.
Moderate Safety Concerns with Anastazole Based on Adverse Event Data
80,386 FDA adverse event reports analyzed
Last updated: 2026-05-12
ANASTROZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 80,386 FDA adverse event reports, ANASTROZOLE has a safety score of 60 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ANASTROZOLE include FATIGUE, ARTHRALGIA, NAUSEA, ALOPECIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ANASTROZOLE.
Anastrozole has a safety concern score of 60 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 80,386 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Fatigue, Arthralgia, Nausea. Of classified reports, 67.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and arthralgia are the most frequently reported adverse reactions, indicating potential musculoskeletal and general discomfort.
Serious adverse events, such as malignant neoplasm progression and death, are concerning and warrant close monitoring. Drug interactions and ineffectiveness are reported, suggesting potential issues with concurrent medications or treatment efficacy.
Patients taking Anastrozole should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Anastrozole may interact with other drugs, and its ineffectiveness has been reported, so caution is advised when used in combination with other medications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Anastrozole received a safety concern score of 60/100 (elevated concern). This is based on a 67.9% serious event ratio across 35,158 classified reports. The score accounts for 80,386 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 31,193, Male: 1,575, Unknown: 136. The most frequently reported age groups are age 63 (858 reports), age 62 (778 reports), age 69 (772 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,158 classified reports for ANASTROZOLE:
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.
Anastrozole may interact with other drugs, and its ineffectiveness has been reported, so caution is advised when used in combination with other medications.
If you are taking Anastrozole, here are important things to know. The most commonly reported side effects include fatigue, arthralgia, nausea, alopecia, diarrhoea. 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 and follow-up are crucial to manage potential side effects and ensure treatment efficacy. 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 a focus on monitoring serious adverse events and ensuring patient safety during treatment.
The FDA has received approximately 80,386 adverse event reports associated with Anastrozole. 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 Anastrozole include Fatigue, Arthralgia, Nausea, Alopecia, Diarrhoea. By volume, the top reported reactions are: Fatigue (3,256 reports), Arthralgia (3,157 reports), Nausea (2,647 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Anastrozole.
Out of 35,158 classified reports, 23,873 (67.9%) were classified as serious and 11,285 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 Anastrozole break down by patient sex as follows: Female: 31,193, Male: 1,575, Unknown: 136. 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 Anastrozole adverse events are: age 63: 858 reports, age 62: 778 reports, age 69: 772 reports, age 65: 763 reports, age 60: 761 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 Anastrozole 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 Anastrozole include: Pain, Headache, Asthenia, Dyspnoea, Dizziness. 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 Anastrozole 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.
Anastrozole has a safety concern score of 60 out of 100 (elevated 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. Fatigue and arthralgia are the most frequently reported adverse reactions, indicating potential musculoskeletal and general discomfort.
Key safety signals identified in Anastrozole's adverse event data include: Malignant neoplasm progression and death are significant serious adverse events.. Drug ineffectiveness and drug interactions are noted, indicating potential treatment challenges.. Alopecia and decreased appetite are common, affecting quality of life.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Anastrozole may interact with other drugs, and its ineffectiveness has been reported, so caution is advised when used in combination with other medications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Anastrozole.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring and follow-up are crucial to manage potential side effects and ensure treatment efficacy.
Anastrozole has 80,386 adverse event reports on file with the FDA. Serious adverse events, such as malignant neoplasm progression and death, are concerning and warrant close monitoring. The volume of reports for Anastrozole reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety during treatment. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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