What the label lists and what reports show
Trabectedin side effects
Trabectedin's FDA label: “The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache.” FAERS holds 2,310 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 neutropenia (248 reports).
- No generic listed
Check it at the source: the trabectedin FDA label on DailyMed (effective June 29, 2026, Apotex Corp.); 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 EVDI?EVDI can cause serious side effects, including: Severe infections due to decreased white blood cells. Decreased or low white blood cell counts can lead to severe infection throughout the body (sepsis) and death. Tell your healthcare provider right away if you develop fever or other signs of infection. Muscle problems (rhabdomyolysis). EVDI can cause severe muscle problems and increased levels of an enzyme in your blood called creatine phosphokinase (CPK). Muscle problems can lead to death. Tell your healthcare provider right away if you develop severe muscle pain or weakness or if your urine changes to a reddish-brown color. Liver problems. Increased liver enzymes in your blood and severe liver problems, including liver failure, can happen. […]
Source: FDA drug label, Apotex Corp., effective June 29, 2026 (SPL set c1d50f5c-4202-27f3-4798-a9708114ddea), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | All Grades b (%) | Grades 3 to 4 (%) | All Grades (%) | Grades 3 to 4 (%) |
|---|---|---|---|---|
| Nausea | 75 | 7 | 50 | 1.7 |
| Vomiting | 46 | 6 | 22 | 1.2 |
| Constipation | 37 | 0.8 | 31 | 0.6 |
| Diarrhea | 35 | 1.6 | 23 | 0 |
| Fatigue c | 69 | 8 | 52 | 1.7 |
| Peripheral edema | 28 | 0.8 | 13 | 0.6 |
| Decreased appetite | 37 | 1.9 | 21 | 0.6 |
| Dyspnea | 25 | 4.2 | 20 | 1.2 |
| Headache | 25 | 0.3 | 19 | 0 |
| Arthralgia | 15 | 0 | 8 | 1.2 |
| Myalgia | 12 | 0 | 6 | 0 |
| Insomnia | 15 | 0.3 | 9 | 0 |
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 discussed in more detail in other sections of the labeling: Anaphylaxis [see Contraindications (4) ] Neutropenic Sepsis [see Warnings and Precautions (5.1) ] Rhabdomyolysis [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Cardiomyopathy [see Warnings and Precautions (5.4) ] Capillary Leak Syndrome [see Warnings and Precautions (5.5) ] Extravasation Resulting in Tissue Necrosis [see Warnings and Precautions (5.6) ] The most common (≥20%) adverse reactions are nausea, fatigue, vomiting, constipation, decreased appetite, diarrhea, peripheral edema, dyspnea, and headache. The most common (≥5%) grades 3 to 4 laboratory abnormalities are: neutropenia, increased ALT, thrombocytopenia, anemia, increased AST, and increased creatine phosphokinase. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp at 1-800-706-5575 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. …
Source: FDA drug label, Apotex Corp., effective June 29, 2026 (SPL set c1d50f5c-4202-27f3-4798-a9708114ddea), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,310 reports list trabectedin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 445 are coded as a death and 1,035 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?
- Trabectedin: 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