What the label lists and what reports show
Romidepsin side effects
Romidepsin's FDA label: “The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis.” FAERS holds 1,666 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 nausea (122 reports).
- Generic listed
Check it at the source: the romidepsin FDA label on DailyMed (effective January 31, 2023, Celgene Corporation); 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 ISTODAX?ISTODAX may cause serious side effects, including: • Low blood cell counts: Your healthcare provider will regularly do blood tests to check your blood counts. o Low platelets: can cause unusual bleeding or bruising under the skin. Talk to your healthcare provider right away if this happens. o Low red blood cells: may make you feel tired and you may get tired easily. You may look pale and feel short of breath. Tell your healthcare provider if you have these symptoms. o Low white blood cells: can cause you to get infections, which may be serious. • Serious infections. People receiving ISTODAX can develop serious infections that can sometimes lead to death. These infections can happen during and after treatment with ISTODAX. Your risk of infection may be higher if you have had chemotherapy in the past. […]
Source: FDA drug label, NDA022393 (Bristol-Myers), as published by Celgene Corporation, effective January 31, 2023 (SPL set 03b39d40-90fe-11df-9de6-0002a5d5c51b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis.
Table 2. Adverse Reactions Occurring in >20% of Patients in Either CTCL Study (N=185)
| Reaction | All grades | Grade 3 or 4 | All grades | Grade 3 or 4 |
|---|---|---|---|---|
| Any adverse reactions | 99 (97) | 36 (35) | 83 (100) | 68 (82) |
| Nausea | 57 (56) | 3 (3) | 71 (86) | 5 (6) |
| Asthenia/Fatigue | 54 (53) | 8 (8) | 64 (77) | 12 (14) |
| Infections | 47 (46) | 11 (11) | 45 (54) | 27 (33) |
| Vomiting | 35 (34) | 1 (<1) | 43 (52) | 8 (10) |
| Anorexia | 23 (23) | 1 (<1) | 45 (54) | 3 (4) |
| Hypomagnesemia | 22 (22) | 1 (<1) | 23 (28) | 0 |
| Diarrhea | 20 (20) | 1 (<1) | 22 (27) | 1 (1) |
| Pyrexia | 20 (20) | 4 (4) | 19 (23) | 1 (1) |
| Anemia | 19 (19) | 3 (3) | 60 (72) | 13 (16) |
| Thrombocytopenia | 17 (17) | 0 | 54 (65) | 12 (14) |
| Dysgeusia | 15 (15) | 0 | 33 (40) | 0 |
| Constipation | 12 (12) | 2 (2) | 32 (39) | 1 (1) |
| Neutropenia | 11 (11) | 4 (4) | 47 (57) | 22 (27) |
| Hypotension | 7 (7) | 3 (3) | 19 (23) | 3 (4) |
| Pruritus | 7 (7) | 0 | 26 (31) | 5 (6) |
| Hypokalemia | 6 (6) | 0 | 17 (20) | 2 (2) |
| Dermatitis/Exfoliative dermatitis | 4 (4) | 1 (<1) | 22 (27) | 7 (8) |
| Hypocalcemia | 4 (4) | 0 | 43 (52) | 5 (6) |
| Leukopenia | 4 (4) | 0 | 38 (46) | 18 (22) |
| Lymphopenia | 4 (4) | 0 | 47 (57) | 31 (37) |
| Alanine aminotransferase increased | 3 (3) | 0 | 18 (22) | 2 (2) |
| Aspartate aminotransferase increased | 3 (3) | 0 | 23 (28) | 3 (4) |
| Hypoalbuminemia | 3 (3) | 1 (<1) | 40 (48) | 3 (4) |
| Electrocardiogram ST-T wave changes | 2 (2) | 0 | 52 (63) | 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 described in more detail in other sections of the prescribing information. • Myelosuppression [see Warnings and Precautions (5.1) ] • Infections [see Warnings and Precautions (5.2) ] • Electrocardiographic Changes [see Warnings and Precautions (5.3) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis. Grade 3‐4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or the 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 data in the WARNINGS AND PRECAUTIONS reflect exposure to ISTODAX in four clinical trials involving 363 patients with T-cell lymphoma, including 185 patients with CTCL. ISTODAX was administered as a single agent at a dosage of 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle. …
Source: FDA drug label, NDA022393 (Bristol-Myers), as published by Celgene Corporation, effective January 31, 2023 (SPL set 03b39d40-90fe-11df-9de6-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,666 reports list romidepsin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 444 are coded as a death and 564 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, 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?
- Romidepsin: 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