What the label lists and what reports show
Capmatinib side effects
Capmatinib's FDA label: “The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.” FAERS holds 2,345 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 peripheral swelling (288 reports).
- No generic listed
Check it at the source: the capmatinib FDA label on DailyMed (effective December 15, 2025, Novartis Pharmaceuticals Corporation); 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 TABRECTA?TABRECTA may cause serious side effects, including: Lung or breathing problems. TABRECTA may cause inflammation of the lungs that can cause death. Tell your healthcare provider right away if you develop any new or worsening symptoms, including: ◦ cough ◦ fever ◦ trouble breathing or shortness of breath Liver problems. TABRECTA may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start treatment and during treatment with TABRECTA. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set 455892c3-d144-4ba8-9ab4-79cabff9876d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
Table 3: Adverse Reactions (≥ 10%) in Patients Who Received TABRECTA in GEOMETRY mono-1
| Reaction | Adverse reactions Grades 1 to 4 (%) | TABRECTA (N = 373) Grades 3 to 4 (%) |
|---|---|---|
| Edema a | 59 | 13 |
| Musculoskeletal pain b | 40 | 4.3 |
| Fatigue c | 34 | 8 |
| Pyrexia d | 14 | 0.8 |
| Weight decreased | 11 | 0.5 |
| Nausea | 46 | 2.4 |
| Vomiting | 28 | 2.4 |
| Constipation | 19 | 0.8 |
| Diarrhea | 19 | 0.5 |
| Dyspnea | 25 | 7 |
| Cough e | 21 | 0.5 |
| Pneumonia f | 13 | 6 |
| Decreased appetite | 21 | 1.1 |
| Rash g | 13 | 0.5 |
| Dizziness h | 13 | 0.5 |
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 described elsewhere in the labeling: ILD/Pneumonitis [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Pancreatic Toxicity [see Warnings and Precautions (5.3)] Hypersensitivity reactions [see Warnings and Precautions (5.4)] The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. Metastatic Non-Small Cell Lung Cancer The safety of TABRECTA was evaluated in GEOMETRY mono-1 [see Clinical Studies (14)]. Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N = 373). Among patients who received TABRECTA, 37% were exposed for at least 6 months and 22% were exposed for at least one year. Serious adverse reactions occurred in 53% of patients who received TABRECTA. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 15, 2025 (SPL set 455892c3-d144-4ba8-9ab4-79cabff9876d), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,345 reports list capmatinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 566 are coded as a death and 391 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 20 reactions below, 15 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?
- Capmatinib: 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