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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NINTEDANIB: 26,243 Adverse Event Reports & Safety Profile

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26,243
Total FAERS Reports
5,822 (22.2%)
Deaths Reported
9,433
Hospitalizations
26,243
As Primary/Secondary Suspect
854
Life-Threatening
490
Disabilities
None
Status

FDA Application: 212609 ·

First Report: 1991 · Latest Report: 20250925

What Are the Most Common NINTEDANIB Side Effects?

#1 Most Reported
Diarrhoea
9,103 reports (34.7%)
#2 Most Reported
Nausea
4,198 reports (16.0%)
#3 Most Reported
Dyspnoea
3,080 reports (11.7%)

All NINTEDANIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 9,103 34.7% 1,063 3,967
Nausea 4,198 16.0% 349 1,832
Dyspnoea 3,080 11.7% 500 1,692
Decreased appetite 2,832 10.8% 348 1,390
Death 2,790 10.6% 2,783 545
Weight decreased 2,628 10.0% 309 1,278
Vomiting 2,524 9.6% 238 1,183
Fatigue 2,511 9.6% 261 1,094
Cough 2,193 8.4% 220 1,016
Idiopathic pulmonary fibrosis 1,905 7.3% 960 909
Constipation 1,756 6.7% 144 803
Abdominal pain upper 1,664 6.3% 103 751
Asthenia 1,487 5.7% 178 750
Headache 1,461 5.6% 66 577
Abdominal discomfort 1,418 5.4% 76 635
Pneumonia 1,260 4.8% 431 1,020
Dizziness 1,145 4.4% 73 529
Productive cough 1,027 3.9% 120 561
Malaise 929 3.5% 98 429
Abdominal pain 905 3.5% 100 446

Who Reports NINTEDANIB Side Effects? Age & Gender Data

Gender: 41.8% female, 58.2% male. Average age: 70.7 years. Most reports from: US. View detailed demographics →

Is NINTEDANIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 1
2010 2 0 2
2011 5 0 4
2012 5 1 4
2013 19 4 11
2014 184 38 73
2015 1,222 214 558
2016 1,451 411 815
2017 1,577 361 767
2018 1,497 403 582
2019 1,575 384 709
2020 1,790 385 701
2021 1,931 400 793
2022 1,850 377 776
2023 1,600 363 607
2024 1,494 380 584
2025 622 132 248

View full timeline →

What Is NINTEDANIB Used For?

IndicationReports
Idiopathic pulmonary fibrosis 13,678
Product used for unknown indication 6,075
Interstitial lung disease 2,999
Pulmonary fibrosis 1,539
Lung adenocarcinoma 793
Non-small cell lung cancer 580
Systemic sclerosis pulmonary 214
Adenocarcinoma 206
Systemic scleroderma 204
Lung neoplasm malignant 127

NINTEDANIB vs Alternatives: Which Is Safer?

NINTEDANIB vs NINTEDANIB ESYLATE NINTEDANIB vs NIRAPARIB NINTEDANIB vs NIRMATRELVIR\RITONAVIR NINTEDANIB vs NIROGACESTAT NINTEDANIB vs NIROGACESTAT HYDROBROMIDE NINTEDANIB vs NIRSEVIMAB NINTEDANIB vs NIRSEVIMAB-ALIP NINTEDANIB vs NITAZOXANIDE NINTEDANIB vs NITISINONE NINTEDANIB vs NITRAZEPAM

Official FDA Label for NINTEDANIB

Official prescribing information from the FDA-approved drug label.