What the label lists and what reports show
Nintedanib side effects
Nintedanib's FDA label: “Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension.” FAERS holds 31,339 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (10,159 reports).
- Generic listed
Check it at the source: the nintedanib FDA label on DailyMed (effective November 20, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of OFEV?OFEV may cause serious side effects, including: See " What is the most important information I should know about OFEV? " liver problems. Call your doctor right away if you have unexplained symptoms such as yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV. diarrhea, nausea, and vomiting. While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have diarrhea, nausea, or vomiting or if these symptoms do not go away or become worse. […]
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 20, 2025 (SPL set da1c9f37-779e-4682-816f-93d0faa4cfc9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension.
Table 2 Adverse Reactions Occurring in ≥5% of OFEV-treated Patients with Systemic Sclerosis-Associated Interstitial Lung Disease and More Commonly Than Placebo in Study 4
| Adverse Reaction | OFEV, 150 mg n=288 | Placebo n=288 |
|---|---|---|
| Diarrhea | 76% | 32% |
| Nausea | 32% | 14% |
| Vomiting | 25% | 10% |
| Skin ulcer | 18% | 17% |
| Abdominal pain a | 18% | 11% |
| Liver enzyme elevation b | 13% | 3% |
| Weight decreased | 12% | 4% |
| Fatigue | 11% | 7% |
| Decreased appetite | 9% | 4% |
| Headache | 9% | 8% |
| Pyrexia | 6% | 5% |
| Back pain | 6% | 4% |
| Dizziness | 6% | 4% |
| Hypertension c | 5% | 2% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Elevated Liver Enzymes and Drug-Induced Liver Injury [see Warnings and Precautions (5.2) ] Gastrointestinal Disorders [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Arterial Thromboembolic Events [see Warnings and Precautions (5.5) ] Risk of Bleeding [see Warnings and Precautions (5.6) ] Gastrointestinal Perforation [see Warnings and Precautions (5.7) ] Nephrotic Range Proteinuria [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of OFEV was evaluated in over 1000 IPF patients, 332 patients with chronic fibrosing ILDs with a progressive phenotype, and over 280 patients with SSc-ILD. …
Source: FDA drug label, Boehringer Ingelheim Pharmaceuticals, Inc., effective November 20, 2025 (SPL set da1c9f37-779e-4682-816f-93d0faa4cfc9), via openFDA; the full label on DailyMed
What do FAERS reports show?
31,339 reports list nintedanib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,218 are coded as a death and 10,549 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nintedanib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions