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Romidepsin Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 24, 2023.

Applies to romidepsin: intravenous powder for solution, intravenous solution.

Serious side effects of Romidepsin

Along with its needed effects, romidepsin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking romidepsin:

More common

Other side effects of Romidepsin

Some side effects of romidepsin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to romidepsin: intravenous powder for injection, intravenous solution.

Gastrointestinal

Very common (10% or more): Nausea (86%), vomiting (52%), constipation (40%), diarrhea (36%), abdominal pain (14%)

Common (1% to 10%): Stomatitis[Ref]

General

The most commonly reported adverse events included neutropenia, lymphopenia, thrombocytopenia, infections, nausea, fatigue, vomiting, anorexia, anemia, and ECG T-wave changes.

The most commonly reported events leading to discontinuation included infection, fatigue, dyspnea, QT prolongation, and hypomagnesemia.[Ref]

Hematologic

Very common (10% or more): Anemia (72%), neutropenia (66%), leukopenia (46%), thrombocytopenia (65%), lymphopenia (57%)[Ref]

Cardiovascular

Very common (10% or more): ST-T wave changes on ECG (63%), hypotension (23%)

Common (1% to 10%): Tachycardia, supraventricular arrhythmia, ventricular arrhythmia, edema, deep vein thrombosis, chest pain

Frequency not reported: QT prolongation[Ref]

Metabolic

Very common (10% or more): Anorexia (54%), hypocalcemia (52%), hyperglycemia (51%), hypoalbuminemia (48%), hyperuricemia (33%), hypomagnesemia (28%), hypermagnesemia (27%), hypophosphatemia (27%), hypokalemia (20%), weight loss (15%), hyponatremia (20%),

Common (1% to 10%): Dehydration, hypoalbuminemia, hyperuricemia, tumor lysis syndrome[Ref]

Nervous system

Very common (10% or more): Dysgeusia (40%), headache (34%)

Common (1% to 10%): Syncope, dizziness[Ref]

Hepatic

Very common (10% or more): AST elevations (28%), ALT elevations (22%)

Common (1% to 10%): Hyperbilirubinemia[Ref]

Dermatologic

Very common (10% or more): Pruritus (31%), dermatitis/exfoliative dermatitis (27%)

Common (1% to 10%): Rash[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Immunologic

Very common (10% or more): Infections (54%)

Common (1% to 10%): Sepsis, upper respiratory infection, urinary tract infection, pneumonia, cellulitis, oral candidiasis, central line infection, catheter related infection

Other

Very common (10% or more): Asthenia/fatigue (77%), pyrexia (47%), chills (17%)

Common (1% to 10%): Febrile neutropenia

Respiratory

Very common (10% or more): Cough (21%), dyspnea (21%)

Common (1% to 10%): Pulmonary embolism, pneumonitis

Musculoskeletal

Common (1% to 10%): Muscle spasms, myalgia

References

1. Product Information. Istodax (romidepsin). Gloucester Pharmaceuticals. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.