85/100 · Critical
Manufactured by Genentech, Inc.
High Serious Adverse Events with Atezolizumab
56,768 FDA adverse event reports analyzed
Last updated: 2026-05-12
ATEZOLIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 56,768 FDA adverse event reports, ATEZOLIZUMAB 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 ATEZOLIZUMAB include DEATH, OFF LABEL USE, DISEASE PROGRESSION, PYREXIA, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ATEZOLIZUMAB.
Atezolizumab 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 56,768 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Death, Off Label Use, Disease Progression. Of classified reports, 95.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Atezolizumab is associated with a high number of serious adverse events, particularly respiratory and gastrointestinal issues.
The drug has a wide range of reported reactions, indicating potential for diverse side effects. Significant reports of interstitial lung disease and pneumonia raise concerns about pulmonary safety.
Patients taking Atezolizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Atezolizumab can cause severe pulmonary reactions, including interstitial lung disease and pneumonia, and patients should be monitored closely for these conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Atezolizumab received a safety concern score of 85/100 (high concern). This is based on a 95.4% serious event ratio across 36,336 classified reports. The score accounts for 56,768 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: Male: 19,099, Female: 11,414, Unknown: 1. The most frequently reported age groups are age 8 (1,096 reports), age 68 (1,017 reports), age 70 (998 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 36,336 classified reports for ATEZOLIZUMAB:
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.
Atezolizumab can cause severe pulmonary reactions, including interstitial lung disease and pneumonia, and patients should be monitored closely for these conditions.
If you are taking Atezolizumab, here are important things to know. The most commonly reported side effects include death, off label use, disease progression, pyrexia, 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 of blood counts and thyroid function 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.
The FDA continues to monitor the safety of Atezolizumab and has not issued any specific warnings or restrictions based on the current data.
The FDA has received approximately 56,768 adverse event reports associated with Atezolizumab. 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 Atezolizumab include Death, Off Label Use, Disease Progression, Pyrexia, Diarrhoea. By volume, the top reported reactions are: Death (4,048 reports), Off Label Use (3,259 reports), Disease Progression (1,999 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Atezolizumab.
Out of 36,336 classified reports, 34,666 (95.4%) were classified as serious and 1,670 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 Atezolizumab break down by patient sex as follows: Male: 19,099, Female: 11,414, Unknown: 1. 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 Atezolizumab adverse events are: age 8: 1,096 reports, age 68: 1,017 reports, age 70: 998 reports, age 69: 981 reports, age 67: 941 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 Atezolizumab adverse event reports is Genentech, 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 Atezolizumab include: Fatigue, Anaemia, Pneumonia, Decreased Appetite, Nausea. 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 Atezolizumab 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.
Atezolizumab 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. Atezolizumab is associated with a high number of serious adverse events, particularly respiratory and gastrointestinal issues.
Key safety signals identified in Atezolizumab's adverse event data include: Interstitial lung disease and pneumonia are key safety signals, with 773 and 1081 reports respectively.. Neutropenia and thrombocytopenia are also notable, with 765 and 756 reports each.. Hypothyroidism and hyperthyroidism are reported, indicating potential endocrine effects.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Atezolizumab can cause severe pulmonary reactions, including interstitial lung disease and pneumonia, and patients should be monitored closely for these conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Atezolizumab.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of blood counts and thyroid function is recommended.
Atezolizumab has 56,768 adverse event reports on file with the FDA. The drug has a wide range of reported reactions, indicating potential for diverse side effects. The volume of reports for Atezolizumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Atezolizumab and has not issued any specific warnings or restrictions based on the current data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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