85/100 · Critical
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
High Serious Adverse Event Rate for Afatinib
Last updated: 2026-05-12
AFATINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of FDA adverse event reports, AFATINIB 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. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AFATINIB.
Afatinib 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 N/A adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
Of classified reports, 86.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. 86.4% of reports are serious adverse events.
The majority of reports involve older adults (65-78 years). Female patients report more adverse events than males.
Patients taking Afatinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are noted, but caution is advised in elderly patients due to higher report frequency. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Afatinib received a safety concern score of 85/100 (high concern). This is based on a 86.4% serious event ratio across 6,516 classified reports. The score accounts for N/A total adverse event reports and 0 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 3,466, Male: 2,099, Unknown: 12. The most frequently reported age groups are age 65 (182 reports), age 70 (164 reports), age 67 (162 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 6,516 classified reports for AFATINIB:
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.
No specific drug interactions are noted, but caution is advised in elderly patients due to higher report frequency.
If you are taking Afatinib, here are important things to know. Patients should report any new symptoms to their healthcare provider promptly. Regular follow-ups are recommended, especially for older adults. 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 continues to monitor Afatinib for safety, and updates will be provided as necessary.
The FDA has received approximately N/A adverse event reports associated with Afatinib. 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.
Out of 6,516 classified reports, 5,627 (86.4%) were classified as serious and 889 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 Afatinib break down by patient sex as follows: Female: 3,466, Male: 2,099, Unknown: 12. 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 Afatinib adverse events are: age 65: 182 reports, age 70: 164 reports, age 67: 162 reports, age 68: 162 reports, age 69: 160 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 Afatinib adverse event reports is Boehringer Ingelheim 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.
You can report adverse events from Afatinib 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.
Afatinib 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. 86.4% of reports are serious adverse events.
Key safety signals identified in Afatinib's adverse event data include: High percentage of serious adverse events (86.4%).. Age distribution shows a significant number of reports from older adults.. Gender distribution indicates more reports from females.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are noted, but caution is advised in elderly patients due to higher report frequency. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Afatinib.
Patients should report any new symptoms to their healthcare provider promptly. Regular follow-ups are recommended, especially for older adults.
Afatinib has N/A adverse event reports on file with the FDA. The majority of reports involve older adults (65-78 years). The volume of reports for Afatinib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Afatinib for safety, and updates will be provided as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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