Romidepsin side effects: what 1,664 FDA adverse event reports show
Drug class
Who reports
1,664 reports · 87% serious · 444 with death outcome · 44% female
Used for
Romidepsin injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. Romidepsin injection is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ( 1 )
What it is
Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide. At room temperature, romidepsin is a white to off-white crystalline powder and is described chemically as (1S,4S.
Boxed warning
None in the current label
Causality screen of the 23 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 15 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Cytopenia | 24 | 25.3 17.0–37.7ROR 25.7 · χ² 536 / p 7e-119 | 24.8 EB05 17.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 | no trial data cached |
| Electrocardiogram qt prolonged | 70 | 24.5 19.5–30.9ROR 25.6 · χ² 1,556 / p <1e-300 | 24.3 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 · ♀ 85% (drug 44%) · 97% clinician | no trial data cached |
| Therapy partial responder | 26 | 21.8 14.9–31.9ROR 22.1 · χ² 494 / p 1e-109 | 21.4 EB05 15.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 · 100% clinician | no trial data cached |
| Haematotoxicity | 15 | 20.4 12.3–33.8ROR 20.6 · χ² 257 / p 3e-58 | 19.7 EB05 12.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Blood lactate dehydrogenase increased | 18 | 14.2 9.0–22.5ROR 14.4 · χ² 208 / p 2e-47 | 13.5 EB05 8.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 10.0 | no trial data cached |
| Thrombocytopenia (low platelets) | 120 | 13.6 11.4–16.1ROR 14.5 · χ² 1,389 / p <1e-300 | 13.5 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 99% clinician | no trial data cached |
| Lymphopenia | 15 | 13.4 8.1–22.2ROR 13.5 · χ² 160 / p 5e-37 | 12.3 EB05 7.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | no trial data cached |
| Lymphocyte count decreased | 14 | 10.0 5.9–16.8ROR 10.0 · χ² 104 / p 9e-25 | 8.5 EB05 5.0 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 | no trial data cached |
| Lymphoma | 12 | 9.8 5.5–17.1ROR 9.8 · χ² 86 / p 1e-20 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.5 | no trial data cached |
| Acute myeloid leukaemia | 12 | 9.7 5.5–17.1ROR 9.8 · χ² 85 / p 1e-20 | 8.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Product storage error | 63 | 9.2 7.2–11.7ROR 9.5 · χ² 452 / p 1e-100 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 94% clinician | no trial data cached |
| Cytomegalovirus infection | 12 | 9.1 5.2–16.0ROR 9.1 · χ² 78 / p 4e-19 | 7.4 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Febrile neutropenia | 47 | 8.9 6.7–11.8ROR 9.2 · χ² 324 / p 9e-73 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 98% clinician | no trial data cached |
| Platelet count decreased | 74 | 8.7 7.0–10.9ROR 9.1 · χ² 502 / p 1e-111 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 99% clinician | no trial data cached |
| Neutrophil count decreased | 28 | 8.7 6.0–12.6ROR 8.8 · χ² 184 / p 4e-42 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
| Mouth ulceration | 14 | 8.4 5.0–14.1ROR 8.4 · χ² 84 / p 3e-20 | 7.0 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Atrial fibrillation | 61 | 7.9 6.2–10.1ROR 8.1 · χ² 361 / p 9e-81 | 7.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 100% clinician | no trial data cached |
| Disease progression | 65 | 6.9 5.5–8.8ROR 7.2 · χ² 326 / p 3e-73 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 95% clinician | no trial data cached |
| Bone marrow failure | 11 | 6.8 3.8–12.2ROR 6.8 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Malignant neoplasm progression | 52 | 6.4 4.9–8.4ROR 6.6 · χ² 234 / p 4e-53 | 6.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 61 | 5.7 4.4–7.3ROR 5.8 · χ² 231 / p 2e-52 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 98% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 25 | 5.6 3.8–8.3ROR 5.7 · χ² 91 / p 6e-22 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · 100% clinician | no trial data cached |
| Myelosuppression | 11 | 4.1 2.3–7.3ROR 4.1 · χ² 23 / p 1e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Thrombocytopenia (low platelets) | 120 | 13.6 11.4–16.1ROR 14.5 · χ² 1,389 / p <1e-300 | 13.5 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 99% clinician | no trial data cached |
| Platelet count decreased | 74 | 8.7 7.0–10.9ROR 9.1 · χ² 502 / p 1e-111 | 8.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 99% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 70 | 24.5 19.5–30.9ROR 25.6 · χ² 1,556 / p <1e-300 | 24.3 EB05 19.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 · ♀ 85% (drug 44%) · 97% clinician | no trial data cached |
| Disease progression | 65 | 6.9 5.5–8.8ROR 7.2 · χ² 326 / p 3e-73 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 95% clinician | no trial data cached |
| Product storage error | 63 | 9.2 7.2–11.7ROR 9.5 · χ² 452 / p 1e-100 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 94% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 61 | 5.7 4.4–7.3ROR 5.8 · χ² 231 / p 2e-52 | 5.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 98% clinician | no trial data cached |
| Atrial fibrillation | 61 | 7.9 6.2–10.1ROR 8.1 · χ² 361 / p 9e-81 | 7.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 100% clinician | no trial data cached |
| Malignant neoplasm progression | 52 | 6.4 4.9–8.4ROR 6.6 · χ² 234 / p 4e-53 | 6.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 | no trial data cached |
| Febrile neutropenia | 47 | 8.9 6.7–11.8ROR 9.2 · χ² 324 / p 9e-73 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 · 98% clinician | no trial data cached |
| Neutrophil count decreased | 28 | 8.7 6.0–12.6ROR 8.8 · χ² 184 / p 4e-42 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
| Therapy partial responder | 26 | 21.8 14.9–31.9ROR 22.1 · χ² 494 / p 1e-109 | 21.4 EB05 15.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 · 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 25 | 5.6 3.8–8.3ROR 5.7 · χ² 91 / p 6e-22 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · 100% clinician | no trial data cached |
| Cytopenia | 24 | 25.3 17.0–37.7ROR 25.7 · χ² 536 / p 7e-119 | 24.8 EB05 17.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 | no trial data cached |
| Blood lactate dehydrogenase increased | 18 | 14.2 9.0–22.5ROR 14.4 · χ² 208 / p 2e-47 | 13.5 EB05 8.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 10.0 | no trial data cached |
| Lymphopenia | 15 | 13.4 8.1–22.2ROR 13.5 · χ² 160 / p 5e-37 | 12.3 EB05 7.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Romidepsin?
In FDA FAERS, the most frequently co-reported reaction terms for Romidepsin are thrombocytopenia, platelet count decreased, electrocardiogram qt prolonged, neutropenia, atrial fibrillation, febrile neutropenia. 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 Romidepsin have an FDA boxed warning?
No. The FDA label retrieved for Romidepsin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Romidepsin 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 61894b77-f29c-4a81-ad85-bd3a698233a4, effective 20250904; matched on
openfda.generic_name.exact:"ROMIDEPSIN") - 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, 38 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.