82/100 · Critical
Manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
Nintedanib Adverse Events: High Incidence of Serious Pulmonary and Gastrointestinal Reactions
85,660 FDA adverse event reports analyzed
Last updated: 2026-05-12
NINTEDANIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.. Based on analysis of 85,660 FDA adverse event reports, NINTEDANIB has a safety score of 82 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 NINTEDANIB include DIARRHOEA, NAUSEA, DYSPNOEA, COUGH, DECREASED APPETITE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NINTEDANIB.
Nintedanib has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 85,660 adverse event reports for this medication, which is primarily manufactured by Boehringer Ingelheim Pharmaceuticals, Inc..
The most commonly reported adverse events include Diarrhoea, Nausea, Dyspnoea. Of classified reports, 67.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nintedanib reports a high incidence of serious pulmonary reactions, including idiopathic pulmonary fibrosis and interstitial lung disease.
Gastrointestinal issues such as diarrhea, nausea, and weight decrease are common and often severe. The drug is associated with a significant number of serious adverse events, particularly in older adults.
Patients taking Nintedanib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nintedanib is contraindicated in patients with active or uncontrolled pulmonary fibrosis. It may also interact with other drugs affecting liver enzymes, requiring dose adjustments. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nintedanib received a safety concern score of 82/100 (high concern). This is based on a 67.4% serious event ratio across 28,778 classified reports. The score accounts for 85,660 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: 14,919, Female: 10,692, Unknown: 9. The most frequently reported age groups are age 76 (827 reports), age 74 (825 reports), age 73 (823 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,778 classified reports for NINTEDANIB:
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.
Nintedanib is contraindicated in patients with active or uncontrolled pulmonary fibrosis. It may also interact with other drugs affecting liver enzymes, requiring dose adjustments.
If you are taking Nintedanib, here are important things to know. The most commonly reported side effects include diarrhoea, nausea, dyspnoea, cough, decreased appetite. 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 pulmonary issues such as shortness of breath and coughing, especially in older adults. Report any gastrointestinal symptoms like severe diarrhea or nausea to your healthcare provider immediately. 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 nintedanib's safety profile, particularly for pulmonary and gastrointestinal side effects. Regular medical check-ups are recommended for patients taking this medication.
The FDA has received approximately 85,660 adverse event reports associated with Nintedanib. 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 Nintedanib include Diarrhoea, Nausea, Dyspnoea, Cough, Decreased Appetite. By volume, the top reported reactions are: Diarrhoea (9,428 reports), Nausea (4,456 reports), Dyspnoea (3,762 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nintedanib.
Out of 28,778 classified reports, 19,406 (67.4%) were classified as serious and 9,372 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 Nintedanib break down by patient sex as follows: Male: 14,919, Female: 10,692, Unknown: 9. 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 Nintedanib adverse events are: age 76: 827 reports, age 74: 825 reports, age 73: 823 reports, age 75: 798 reports, age 77: 789 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 Nintedanib 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.
Beyond the most common reactions, other reported adverse events for Nintedanib include: Death, Weight Decreased, Fatigue, Vomiting, Idiopathic Pulmonary Fibrosis. 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 Nintedanib 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.
Nintedanib has a safety concern score of 82 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. Nintedanib reports a high incidence of serious pulmonary reactions, including idiopathic pulmonary fibrosis and interstitial lung disease.
Key safety signals identified in Nintedanib's adverse event data include: Idiopathic pulmonary fibrosis and interstitial lung disease. Severe gastrointestinal reactions including diarrhea and nausea. High rate of serious adverse events, especially in older patients. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nintedanib is contraindicated in patients with active or uncontrolled pulmonary fibrosis. It may also interact with other drugs affecting liver enzymes, requiring dose adjustments. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nintedanib.
Monitor for signs of pulmonary issues such as shortness of breath and coughing, especially in older adults. Report any gastrointestinal symptoms like severe diarrhea or nausea to your healthcare provider immediately.
Nintedanib has 85,660 adverse event reports on file with the FDA. Gastrointestinal issues such as diarrhea, nausea, and weight decrease are common and often severe. The volume of reports for Nintedanib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors nintedanib's safety profile, particularly for pulmonary and gastrointestinal side effects. Regular medical check-ups are recommended for patients taking this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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