Drug · FAERS side-effect profile with label screen
Trabectedin side effects: what 2,310 FDA adverse event reports show
Brand names
Evdi
openFDA label
Who reports
2,310 reports · 91% serious · 445 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
EVDI is indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen . EVDI is an alkylating drug indicated for the treatment of adult patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen ( 1 )
FDA label, Indications and Usage
What it is
Trabectedin is an alkylating drug with the chemical name (1' R ,6 R ,6a R ,7 R ,13 S ,14 S ,16 R )-5- (acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trim.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 10Labeled (related wording) 6Reporting / coding artifact 2Lab value / disease marker 4Not in label — unassessed 18
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 33 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Haematotoxicity | 64 | 63.1 49.5–80.4ROR 64.9 · χ² 3,824 / p <1e-300 | 61.6 EB05 49.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 40.6 · ♀ 29% (drug 67%) · 95% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 132 | 28.9 24.5–34.1ROR 30.6 · χ² 3,520 / p <1e-300 | 28.7 EB05 24.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 · 98% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 67 | 27.5 21.7–34.9ROR 28.3 · χ² 1,682 / p <1e-300 | 27.2 EB05 22.2 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 · 96% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 160 | 26.1 22.5–30.4ROR 28.0 · χ² 3,842 / p <1e-300 | 26.0 EB05 22.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.4 · 99% clinician | no trial data cached |
| Transaminases increased | 63 | 25.8 20.2–32.9ROR 26.5 · χ² 1,475 / p <1e-300 | 25.6 EB05 20.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 · 97% clinician | no trial data cached |
| Acute myeloid leukaemia | 42 | 24.5 18.2–33.1ROR 25.0 · χ² 923 / p 4e-203 | 24.2 EB05 18.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 | no trial data cached |
| Febrile neutropenia | 161 | 22.1 19.1–25.7ROR 23.7 · χ² 3,228 / p <1e-300 | 22.0 EB05 19.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · 99% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 53 | 21.7 16.7–28.4ROR 22.2 · χ² 1,027 / p 2e-225 | 21.5 EB05 17.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 14.3 · 100% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 68 | 21.1 16.7–26.7ROR 21.8 · χ² 1,284 / p 2e-281 | 21.0 EB05 17.1 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · 96% clinician | no trial data cached |
| Bone marrow failure | 43 | 19.1 14.2–25.7ROR 19.5 · χ² 719 / p 9e-159 | 18.9 EB05 14.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · ♀ 45% (drug 67%) · 95% clinician | no trial data cached |
| Neutrophil count decreased | 83 | 18.6 15.1–23.0ROR 19.3 · χ² 1,367 / p 1e-299 | 18.5 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.3 · 100% clinician | no trial data cached |
| Alanine aminotransferase increased | 125 | 18.5 15.6–22.0ROR 19.5 · χ² 2,054 / p <1e-300 | 18.4 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 · 99% clinician | no trial data cached |
| Aspartate aminotransferase increased | 106 | 18.2 15.1–21.9ROR 19.0 · χ² 1,702 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.0 · 99% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 248 | 16.6 14.8–18.7ROR 18.5 · χ² 3,648 / p <1e-300 | 16.6 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · 98% clinician | no trial data cached |
| Device related infection | 28 | 16.5 11.4–23.8ROR 16.7 · χ² 392 / p 2e-87 | 16.2 EB05 11.6 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.7 · 96% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 202 | 16.5 14.4–18.8ROR 18.0 · χ² 2,930 / p <1e-300 | 16.4 EB05 14.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 · 99% clinician | no trial data cached |
| Hepatic cytolysis | 22 | 16.4 10.8–24.8ROR 16.5 · χ² 302 / p 6e-68 | 15.9 EB05 10.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · 100% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 86 | 15.7 12.7–19.3ROR 16.2 · χ² 1,167 / p 4e-256 | 15.6 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 100% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 41 | 15.0 11.1–20.3ROR 15.2 · χ² 521 / p 1e-115 | 14.8 EB05 11.2 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.8 · 98% clinician | no trial data cached |
| Hepatocellular injury | 23 | 14.7 9.8–22.1ROR 14.8 · χ² 280 / p 4e-63 | 14.2 EB05 9.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 100% clinician | no trial data cached |
| Ejection fraction decreased | 25 | 14.6 9.9–21.6ROR 14.7 · χ² 303 / p 4e-68 | 14.1 EB05 9.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.3 · 100% clinician | no trial data cached |
| Mucosal inflammation | 37 | 12.9 9.4–17.8ROR 13.1 · χ² 394 / p 5e-88 | 12.5 EB05 9.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 100% clinician | no trial data cached |
| Metastases to lung | 15 | 11.8 7.1–19.6ROR 11.9 · χ² 138 / p 4e-32 | 10.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Blood bilirubin increased | 35 | 11.7 8.5–16.3ROR 11.9 · χ² 333 / p 9e-75 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 · ♀ 40% (drug 67%) · 94% clinician | no trial data cached |
| Hepatic function abnormal | 47 | 11.5 8.7–15.3ROR 11.7 · χ² 441 / p 3e-98 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · 100% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 22 | 10.5 6.9–15.9ROR 10.6 · χ² 179 / p 4e-41 | 9.5 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 100% clinician | no trial data cached |
| Generalised oedema | 14 | 10.3 6.1–17.4ROR 10.4 · χ² 109 / p 9e-26 | 8.8 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Anaemia (low red blood cells) | 214 | 10.2 9.0–11.6ROR 11.1 · χ² 1,778 / p <1e-300 | 10.1 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 100% clinician | no trial data cached |
| Disease progression | 130 | 10.0 8.5–11.8ROR 10.6 · χ² 1,051 / p 8e-231 | 9.9 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 98% clinician | no trial data cached |
| Ascites | 31 | 9.6 6.7–13.6ROR 9.7 · χ² 230 / p 4e-52 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 100% clinician | no trial data cached |
| Hepatic failure | 31 | 9.3 6.6–13.2ROR 9.4 · χ² 222 / p 2e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 97% clinician | no trial data cached |
| Acute respiratory distress syndrome | 17 | 8.7 5.4–14.0ROR 8.8 · χ² 109 / p 9e-26 | 7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pneumonitis | 24 | 8.1 5.4–12.0ROR 8.1 · χ² 142 / p 6e-33 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 92% clinician | no trial data cached |
| Cardiomyopathy | 13 | 8.0 4.6–13.7ROR 8.0 · χ² 73 / p 8e-18 | 6.6 EB05 4.0 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Platelet count decreased | 89 | 7.6 6.2–9.3ROR 7.9 · χ² 505 / p 4e-112 | 7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 93% clinician | no trial data cached |
| Myelodysplastic syndrome | 12 | 7.5 4.3–13.2ROR 7.6 · χ² 62 / p 2e-15 | 6.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Neurotoxicity | 14 | 7.3 4.3–12.3ROR 7.4 · χ² 70 / p 3e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Multiple organ dysfunction syndrome | 22 | 7.2 4.7–10.9ROR 7.2 · χ² 111 / p 4e-26 | 6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 95% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 17 | 6.6 4.1–10.6ROR 6.6 · χ² 75 / p 2e-18 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Neoplasm progression | 25 | 6.5 4.4–9.6ROR 6.5 · χ² 110 / p 4e-26 | 5.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 96% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Neutropenia (low neutrophils (infection-fighting cells)) | 248 | 16.6 14.8–18.7ROR 18.5 · χ² 3,648 / p <1e-300 | 16.6 EB05 14.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · 98% clinician | no trial data cached |
| Anaemia (low red blood cells) | 214 | 10.2 9.0–11.6ROR 11.1 · χ² 1,778 / p <1e-300 | 10.1 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 100% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 202 | 16.5 14.4–18.8ROR 18.0 · χ² 2,930 / p <1e-300 | 16.4 EB05 14.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 · 99% clinician | no trial data cached |
| Febrile neutropenia | 161 | 22.1 19.1–25.7ROR 23.7 · χ² 3,228 / p <1e-300 | 22.0 EB05 19.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.0 · 99% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 160 | 26.1 22.5–30.4ROR 28.0 · χ² 3,842 / p <1e-300 | 26.0 EB05 22.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.4 · 99% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 132 | 28.9 24.5–34.1ROR 30.6 · χ² 3,520 / p <1e-300 | 28.7 EB05 24.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 · 98% clinician | no trial data cached |
| Disease progression | 130 | 10.0 8.5–11.8ROR 10.6 · χ² 1,051 / p 8e-231 | 9.9 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 · 98% clinician | no trial data cached |
| Alanine aminotransferase increased | 125 | 18.5 15.6–22.0ROR 19.5 · χ² 2,054 / p <1e-300 | 18.4 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 · 99% clinician | no trial data cached |
| Aspartate aminotransferase increased | 106 | 18.2 15.1–21.9ROR 19.0 · χ² 1,702 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.0 · 99% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 99 | 5.9 4.9–7.2ROR 6.1 · χ² 401 / p 2e-89 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · ♀ 41% (drug 67%) · 96% clinician | no trial data cached |
| Platelet count decreased | 89 | 7.6 6.2–9.3ROR 7.9 · χ² 505 / p 4e-112 | 7.4 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 93% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 86 | 15.7 12.7–19.3ROR 16.2 · χ² 1,167 / p 4e-256 | 15.6 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 100% clinician | no trial data cached |
| Neutrophil count decreased | 83 | 18.6 15.1–23.0ROR 19.3 · χ² 1,367 / p 1e-299 | 18.5 EB05 15.4 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.3 · 100% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 68 | 21.1 16.7–26.7ROR 21.8 · χ² 1,284 / p 2e-281 | 21.0 EB05 17.1 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 · 96% clinician | no trial data cached |
| White blood cell count decreased | 67 | 5.6 4.4–7.1ROR 5.7 · χ² 250 / p 1e-56 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haematotoxicity — n=64, PRR 63.1
- Transaminases increased — n=63, PRR 25.8
- Acute myeloid leukaemia — n=42, PRR 24.5
- Bone marrow failure — n=43, PRR 19.1
- Hepatic cytolysis — n=22, PRR 16.4
- Leukopenia — n=86, PRR 15.7
- Hepatocellular injury — n=23, PRR 14.7
- Cholestasis — n=22, PRR 10.5
- Ascites — n=31, PRR 9.6
- Pneumonitis — n=24, PRR 8.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Trabectedin?
In FDA FAERS, the most frequently co-reported reaction terms for Trabectedin are neutropenia, anaemia, thrombocytopenia, febrile neutropenia, pancytopenia, rhabdomyolysis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Trabectedin have an FDA boxed warning?
No. The FDA label retrieved for Trabectedin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Trabectedin causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c1d50f5c-4202-27f3-4798-a9708114ddea, effective 20260629; matched on
openfda.generic_name.exact:"TRABECTEDIN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 73 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.