85/100 · Critical
Manufactured by AstraZeneca Pharmaceuticals LP
High Safety Concerns with Osimertinib, Particularly for Serious Adverse Events
41,863 FDA adverse event reports analyzed
Last updated: 2026-05-12
OSIMERTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. Based on analysis of 41,863 FDA adverse event reports, OSIMERTINIB 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 OSIMERTINIB include DEATH, MALIGNANT NEOPLASM PROGRESSION, DIARRHOEA, DRUG RESISTANCE, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for OSIMERTINIB.
Osimertinib 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 41,863 adverse event reports for this medication, which is primarily manufactured by Astrazeneca Pharmaceuticals Lp.
The most commonly reported adverse events include Death, Malignant Neoplasm Progression, Diarrhoea. Of classified reports, 93.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common serious adverse events include death, malignant neoplasm progression, and interstitial lung disease.
Significant drug interactions and warnings are present, particularly regarding cardiac and pulmonary issues. A high percentage of reports involve serious adverse events, with a serious/total ratio of 93.2%.
Patients taking Osimertinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Osimertinib carries warnings for drug interactions, particularly with anticoagulants and antiarrhythmics, and requires monitoring for cardiac and pulmonary adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Osimertinib received a safety concern score of 85/100 (high concern). This is based on a 93.2% serious event ratio across 29,200 classified reports. The score accounts for 41,863 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: 16,555, Male: 8,574, Unknown: 3. The most frequently reported age groups are age 70 (380 reports), age 72 (320 reports), age 80 (291 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 29,200 classified reports for OSIMERTINIB:
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.
Osimertinib carries warnings for drug interactions, particularly with anticoagulants and antiarrhythmics, and requires monitoring for cardiac and pulmonary adverse events.
If you are taking Osimertinib, here are important things to know. The most commonly reported side effects include death, malignant neoplasm progression, diarrhoea, drug resistance, fatigue. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of serious adverse events such as interstitial lung disease and cardiac issues. Follow dosing guidelines and be aware of potential drug interactions. 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 studies to further evaluate long-term safety and efficacy.
The FDA has received approximately 41,863 adverse event reports associated with Osimertinib. 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 Osimertinib include Death, Malignant Neoplasm Progression, Diarrhoea, Drug Resistance, Fatigue. By volume, the top reported reactions are: Death (10,777 reports), Malignant Neoplasm Progression (3,073 reports), Diarrhoea (1,521 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Osimertinib.
Out of 29,200 classified reports, 27,214 (93.2%) were classified as serious and 1,986 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 Osimertinib break down by patient sex as follows: Female: 16,555, Male: 8,574, Unknown: 3. 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 Osimertinib adverse events are: age 70: 380 reports, age 72: 320 reports, age 80: 291 reports, age 69: 288 reports, age 71: 285 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 Osimertinib adverse event reports is Astrazeneca Pharmaceuticals Lp. 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 Osimertinib include: Rash, Decreased Appetite, Off Label Use, Drug Ineffective, 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 Osimertinib 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.
Osimertinib 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 most common serious adverse events include death, malignant neoplasm progression, and interstitial lung disease.
Key safety signals identified in Osimertinib's adverse event data include: Death and malignant neoplasm progression are among the top serious adverse events.. Interstitial lung disease and pulmonary edema are notable respiratory issues.. Cardiac disorders, including myocardial infarction and atrial fibrillation, are frequent.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Osimertinib carries warnings for drug interactions, particularly with anticoagulants and antiarrhythmics, and requires monitoring for cardiac and pulmonary adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Osimertinib.
Monitor patients closely for signs of serious adverse events such as interstitial lung disease and cardiac issues. Follow dosing guidelines and be aware of potential drug interactions.
Osimertinib has 41,863 adverse event reports on file with the FDA. Significant drug interactions and warnings are present, particularly regarding cardiac and pulmonary issues. The volume of reports for Osimertinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing studies to further evaluate long-term safety and efficacy. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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