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Nintedanib Side Effects

The most commonly reported side effects of nintedanib include diarrhoea, nausea, and dyspnoea, based on 28,998 FDA adverse event reports from 2013 to 2025.

Nintedanib side effects

Percentages show how often each reaction appears relative to total reports for nintedanib.

1
Diarrhoea32.7%9,486
2
Nausea15.4%4,478
3
Dyspnoea13.0%3,780
4
Cough10.3%2,993
5
Decreased Appetite10.2%2,946
6
Death10.0%2,898
7
Weight Decreased9.8%2,845
8
Fatigue9.6%2,793
9
Vomiting9.1%2,635
10
Idiopathic Pulmonary Fibrosis6.7%1,947
11
Constipation6.7%1,942
12
Headache6.5%1,873
13
Abdominal Pain Upper6.2%1,811
14
Asthenia5.6%1,625
15
Abdominal Discomfort5.4%1,565

These are voluntary reports and do not establish that nintedanib caused these reactions.

Report severity

67.4%Serious19,552 reports
34.0%Hospitalizations9,852 reports
19.8%Fatal5,733 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nintedanib drug interactions

Other drugs that appear in adverse event reports alongside nintedanib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Treprostinil10.3%2,981
2
Docetaxel2.6%747
3
Pirfenidone2.1%616
4
Loperamide-hydrochloride1.5%443
5
Mycophenolate1.0%284
6
Pemetrexed0.8%237
7
Macitentan0.7%211
8
Pembrolizumab0.7%197
9
Rituximab0.7%194
10
Ambrisentan0.6%166
11
Prednisone0.6%165
12
Dupilumab0.6%160
13
Carboplatin0.5%152
14
Selexipag0.5%142
15
Cisplatin0.5%134

Taken alongside

1
Oxygen6.6%1,906
2
Aspirin6.5%1,883
3
Prednisone5.9%1,717
4
Albuterol5.3%1,529
5
Omeprazole5.2%1,521
6
Atorvastatin-calcium4.8%1,406
7
Ergocalciferol4.6%1,332
8
Furosemide4.3%1,235
9
Amlodipine3.9%1,128
10
Fluticasone3.8%1,106
11
Pantoprazole-sodium3.6%1,033
12
Acetaminophen3.6%1,032
13
Levothyroxine-sodium3.4%993
14
Loperamide-hydrochloride3.1%893
15
Metoprolol3.1%892

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports nintedanib side effects

37.1% of nintedanib adverse event reports involve female patients and 51.7% involve male patients. The largest age group is elderly at 77%. These figures reflect who reports side effects, not underlying risk.

Sex

Female37.1%
Male51.7%
Unknown11.2%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6423.3%
65+76.6%

What is nintedanib used for

Conditions and purposes for which patients were taking nintedanib when the adverse event was reported.

Abdominal PainAbnormal Loss Of WeightAcute Interstitial PneumonitisAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma Of ColonAlveolar Lung DiseaseAlveolitisAlveolitis AllergicAnaemiaAngiopathyAnti-neutrophil Cytoplasmic Antibody Positive VasculitisAntisynthetase SyndromeAppendix CancerArteriosclerosis Coronary Artery

Showing 15 of 351 indications

Nintedanib brand names and reporting trend

Nintedanib is sold under brand names including Nintedanib, Ofev.

Brand names

Nintedanib3,556
Ofev180

Quarterly reports (20132025)

20132016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking nintedanib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.