Drug

Trabectedin

73 flagged reaction(s) · 3,240 total co-reports · max PRR 63.1

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Haematotoxicity	64	63.1	64.9	signal
2	Rhabdomyolysis	132	28.9	30.6	signal
3	Hepatotoxicity	67	27.5	28.3	signal
4	Pancytopenia	160	26.1	28.0	signal
5	Transaminases Increased	63	25.8	26.5	signal
6	Acute Myeloid Leukaemia	42	24.5	25.0	signal
7	Febrile Neutropenia	161	22.1	23.7	signal
8	Gamma-glutamyltransferase Increased	53	21.7	22.2	signal
9	Blood Creatine Phosphokinase Increased	68	21.1	21.8	signal
10	Bone Marrow Failure	43	19.1	19.5	signal
11	Neutrophil Count Decreased	83	18.6	19.3	signal
12	Alanine Aminotransferase Increased	125	18.5	19.5	signal
13	Aspartate Aminotransferase Increased	106	18.2	19.0	signal
14	Neutropenia	248	16.6	18.5	signal
15	Device Related Infection	28	16.5	16.7	signal
16	Thrombocytopenia	202	16.5	18.0	signal
17	Hepatic Cytolysis	22	16.4	16.5	signal
18	Leukopenia	86	15.7	16.2	signal
19	Blood Alkaline Phosphatase Increased	41	15.0	15.2	signal
20	Hepatocellular Injury	23	14.7	14.8	signal
21	Ejection Fraction Decreased	25	14.6	14.7	signal
22	Mucosal Inflammation	37	12.9	13.1	signal
23	Metastases To Lung	15	11.8	11.9	signal
24	Blood Bilirubin Increased	35	11.7	11.9	signal
25	Hepatic Function Abnormal	47	11.5	11.7	signal
26	Cholestasis	22	10.5	10.6	signal
27	Generalised Oedema	14	10.3	10.4	signal
28	Anaemia	214	10.2	11.1	signal
29	Disease Progression	130	10.0	10.6	signal
30	Ascites	31	9.6	9.7	signal
31	Hepatic Failure	31	9.3	9.4	signal
32	Acute Respiratory Distress Syndrome	17	8.7	8.8	signal
33	Pneumonitis	24	8.1	8.1	signal
34	Cardiomyopathy	13	8.0	8.0	signal
35	Ovarian Cancer	8	7.8	7.9	signal
36	Platelet Count Decreased	89	7.6	7.9	signal
37	Myelodysplastic Syndrome	12	7.5	7.6	signal
38	Neurotoxicity	14	7.3	7.4	signal
39	Myocarditis	9	7.2	7.2	signal
40	Multiple Organ Dysfunction Syndrome	22	7.2	7.2	signal
41	Sudden Death	8	6.8	6.8	signal
42	Palmar-plantar Erythrodysaesthesia Syndrome	17	6.6	6.6	signal
43	Neoplasm Progression	25	6.5	6.5	signal
44	Bacteraemia	8	6.2	6.2	signal
45	Therapy Partial Responder	10	6.0	6.1	signal
46	Interstitial Lung Disease	32	6.0	6.1	signal
47	Encephalopathy	16	5.9	6.0	signal
48	Acute Kidney Injury	99	5.9	6.1	signal
49	Septic Shock	28	5.9	5.9	signal
50	Myelosuppression	22	5.9	5.9	signal
51	White Blood Cell Count Decreased	67	5.6	5.7	signal
52	Hyperbilirubinaemia	6	5.3	5.3	signal
53	Drug Resistance	14	4.9	5.0	signal
54	Cardiac Failure	43	4.9	4.9	signal
55	Malignant Neoplasm Progression	54	4.8	4.9	signal
56	Acute Hepatic Failure	7	4.7	4.7	signal
57	Metastases To Liver	9	4.7	4.7	signal
58	Lymphopenia	7	4.5	4.5	signal
59	Liver Injury	12	4.5	4.5	signal
60	Liver Function Test Abnormal	14	4.3	4.4	signal
61	Intestinal Obstruction	17	4.1	4.1	signal
62	Disease Recurrence	21	4.0	4.0	signal
63	Agranulocytosis	8	3.9	3.9	signal
64	Thrombotic Microangiopathy	4	3.7	3.8	signal
65	Pneumocystis Jirovecii Pneumonia	4	3.6	3.6	signal
66	Lung Infection	6	3.5	3.5	signal
67	Cytopenia	4	3.0	3.0	no signal
68	Underdose	24	3.0	3.0	signal
69	Complication Associated With Device	4	2.7	2.7	no signal
70	Product Preparation Error	5	2.2	2.2	no signal
71	Osteonecrosis Of Jaw	6	2.2	2.2	no signal
72	Injection Site Extravasation	3	2.2	2.2	no signal
73	Device Malfunction	10	1.4	1.4	no signal