85/100 · Critical
Manufactured by Avet Pharmaceuticals Inc.
High Safety Concerns with Letrozole Tablets, Particularly for Serious Reactions
116,600 FDA adverse event reports analyzed
Last updated: 2026-05-12
LETROZOLE TABLETS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Avet Pharmaceuticals Inc.. Based on analysis of 116,600 FDA adverse event reports, LETROZOLE TABLETS 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 LETROZOLE TABLETS include FATIGUE, NEUTROPENIA, NAUSEA, DIARRHOEA, MALIGNANT NEOPLASM PROGRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LETROZOLE TABLETS.
Letrozole Tablets 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 116,600 adverse event reports for this medication, which is primarily manufactured by Avet Pharmaceuticals Inc..
The most commonly reported adverse events include Fatigue, Neutropenia, Nausea. Of classified reports, 79.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Frequent serious reactions such as neoplasms progression and death indicate significant safety concerns.
Neutropenia and leukopenia are common, highlighting the risk of severe hematological adverse events. A wide range of reactions, including cardiovascular and respiratory issues, suggests a broad safety profile.
Patients taking Letrozole Tablets should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Letrozole tablets may interact with other drugs, potentially exacerbating hematological and other adverse effects. Warnings include the risk of osteonecrosis of the jaw and pulmonary embolism. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Letrozole Tablets received a safety concern score of 85/100 (high concern). This is based on a 79.7% serious event ratio across 45,824 classified reports. The score accounts for 116,600 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: 41,999, Male: 665, Unknown: 36. The most frequently reported age groups are age 70 (1,030 reports), age 63 (986 reports), age 65 (979 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 45,824 classified reports for LETROZOLE TABLETS:
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.
Letrozole tablets may interact with other drugs, potentially exacerbating hematological and other adverse effects. Warnings include the risk of osteonecrosis of the jaw and pulmonary embolism.
If you are taking Letrozole Tablets, here are important things to know. The most commonly reported side effects include fatigue, neutropenia, nausea, diarrhoea, malignant neoplasm progression. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious adverse reactions such as neoplastic progression and hematological issues. Be aware of potential drug interactions and consult a healthcare provider if experiencing any side effects. 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 adverse events for Letrozole tablets, and regulatory actions may be taken based on ongoing safety assessments.
The FDA has received approximately 116,600 adverse event reports associated with Letrozole Tablets. 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 Letrozole Tablets include Fatigue, Neutropenia, Nausea, Diarrhoea, Malignant Neoplasm Progression. By volume, the top reported reactions are: Fatigue (5,815 reports), Neutropenia (4,301 reports), Nausea (4,210 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Letrozole Tablets.
Out of 45,824 classified reports, 36,512 (79.7%) were classified as serious and 9,312 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 Letrozole Tablets break down by patient sex as follows: Female: 41,999, Male: 665, Unknown: 36. 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 Letrozole Tablets adverse events are: age 70: 1,030 reports, age 63: 986 reports, age 65: 979 reports, age 61: 977 reports, age 69: 964 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 Letrozole Tablets adverse event reports is Avet 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 Letrozole Tablets include: White Blood Cell Count Decreased, Arthralgia, Alopecia, Neoplasm Progression, Dyspnoea. 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 Letrozole Tablets 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.
Letrozole Tablets 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. Frequent serious reactions such as neoplasms progression and death indicate significant safety concerns.
Key safety signals identified in Letrozole Tablets's adverse event data include: Neoplastic progression and death are key safety signals, indicating potential risks for serious adverse outcomes.. Neutropenia and leukopenia are frequent, suggesting a high risk of hematological toxicity.. A diverse range of reactions, including cardiovascular and respiratory issues, indicates a broad safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Letrozole tablets may interact with other drugs, potentially exacerbating hematological and other adverse effects. Warnings include the risk of osteonecrosis of the jaw and pulmonary embolism. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Letrozole Tablets.
Monitor for signs of serious adverse reactions such as neoplastic progression and hematological issues. Be aware of potential drug interactions and consult a healthcare provider if experiencing any side effects.
Letrozole Tablets has 116,600 adverse event reports on file with the FDA. Neutropenia and leukopenia are common, highlighting the risk of severe hematological adverse events. The volume of reports for Letrozole Tablets reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors adverse events for Letrozole tablets, and regulatory actions may be taken based on ongoing safety assessments. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Avet Pharmaceuticals Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with LETROZOLE TABLETS:
Drugs related to LETROZOLE TABLETS based on therapeutic use, drug class, or shared indications: