What the label lists and what reports show
Tepotinib side effects
Tepotinib's FDA label: “Most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.” FAERS holds 642 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 oedema (62 reports).
- No generic listed
Check it at the source: the tepotinib FDA label on DailyMed (effective April 17, 2025, EMD Serono, 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 TEPMETKO?TEPMETKO may cause serious side effects, including: See " What is the most important information I should know about TEPMETKO? " Liver problems. TEPMETKO 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 TEPMETKO. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including: your skin or the white part of your eyes turns yellow dark or "tea colored" urine light-colored stools (bowel movements) confusion tiredness loss of appetite for several days or longer nausea and vomiting pain, aching, or tenderness on the right side of your stomach-area (abdomen) weakness swelling in your stomach-area Pancreas problems. TEPMETKO may cause increases in your blood amylase and lipase levels that may indicate a problem with your pancreas. […]
Source: FDA drug label, EMD Serono, Inc., effective April 17, 2025 (SPL set 80a0f1b9-071a-47f5-9e67-32d638a669dc), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash.
Table 2: Adverse Reactions in ≥ 10% of Patients with NSCLC with METex14 Skipping Alterations Who Received TEPMETKO in VISION
| Reaction | Adverse Reactions All Grades Severity as defined by National Cancer Institute Common Terminology Criteria… | TEPMETKO (N=313) Grades 3 to 4 (%) |
|---|---|---|
| Edema Edema includes eye edema, face edema, generalized edema, localized edema, edema,… | 81 | 16 |
| Fatigue Fatigue includes asthenia and fatigue. | 30 | 1.9 |
| Nausea | 31 | 1.3 |
| Diarrhea | 29 | 0.6 |
| Abdominal pain Abdominal pain includes abdominal discomfort, abdominal pain, abdominal… | 19 | 0.6 |
| Constipation | 19 | 0.3 |
| Vomiting Vomiting includes retching and vomiting. | 15 | 1 |
| Musculoskeletal pain Musculoskeletal pain includes arthralgia, arthritis, back pain, bone… | 30 | 3.2 |
| Dyspnea Dyspnea includes dyspnea, dyspnea at rest, and dyspnea exertional. | 24 | 2.6 |
| Cough Cough includes cough, and productive cough. | 18 | 0.3 |
| Pleural effusion | 14 | 4.2 |
| Decreased appetite | 21 | 1.9 |
| Rash Rash includes rash, palmar-plantar erythrodysesthesia syndrome, rash maculo-papular,… | 21 | 1.3 |
| Pneumonia Pneumonia includes pneumonia, pneumonia aspiration, and pneumonia bacterial. | 12 | 3.8 |
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 adverse reactions are described in greater detail elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Pancreatic Toxicity [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥ 20%) were edema, nausea, fatigue, musculoskeletal pain, diarrhea, dyspnea, decreased appetite, and rash. The most common Grade 3 to 4 laboratory abnormalities (≥ 2%) were decreased lymphocytes, decreased albumin, decreased sodium, increased gamma-glutamyltransferase, increased amylase, increased lipase, increased ALT, increased AST, and decreased hemoglobin. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563 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 pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to TEPMETKO in 506 patients with solid tumors enrolled in five open-label, single-arm studies receiving TEPMETKO as single agent at a dose of 450 mg once daily. …
Source: FDA drug label, EMD Serono, Inc., effective April 17, 2025 (SPL set 80a0f1b9-071a-47f5-9e67-32d638a669dc), via openFDA; the full label on DailyMed
What do FAERS reports show?
642 reports list tepotinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 158 are coded as a death and 173 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 21 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?
- Tepotinib: 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