Istodax Side Effects

Generic Name: romidepsin

Note: This page contains information about the side effects of romidepsin. Some of the dosage forms included on this document may not apply to the brand name Istodax.

Not all side effects for Istodax may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to romidepsin: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by romidepsin (the active ingredient contained in Istodax). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking romidepsin, check with your doctor or nurse immediately:

More common
  • Abdominal or stomach cramps or pain
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • bone pain
  • chest pain
  • chills
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine output
  • difficulty with breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • fast or irregular heartbeat
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • joint pain, stiffness, or swelling
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle pain
  • muscle spasms (tetany) or twitching seizures
  • nausea or vomiting
  • numbness or tingling in the hands, fingertips, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swelling of the face, ankles, feet, lower legs, or hands
  • swollen glands
  • trembling
  • tremor
  • troubled breathing
  • troubled breathing with exertion
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Fainting
  • fast, pounding, or irregular heartbeat or pulse
  • swelling

Some of the side effects that can occur with romidepsin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Change in taste
  • constipation
  • cracks in the skin
  • diarrhea
  • itching skin
  • lack or loss of strength
  • loss of appetite
  • loss of heat from the body
  • loss of taste
  • red, swollen skin
  • scaly skin
  • weight loss

For Healthcare Professionals

Applies to romidepsin: intravenous powder for injection

Gastrointestinal

Very common (10% or more): Nausea (up to 86%), vomiting (up to 52%), constipation (up to 40%), diarrhea (up to 36%), abdominal pain (up to 14%)
Common (1% to 10%): Stomatitis

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.

Hematologic

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

Cardiovascular

Very common (10% or more): ST-T wave changes on ECG (up to 63%); Hypotension (up to 23%)
Common (1% to 10%): Tachycardia, supraventricular arrhythmia, ventricular arrhythmia, edema, deep vein thrombosis, chest pain
Frequency not reported: QT prolongation

Metabolic

Very common (10% or more): Anorexia (up to 54%), hypocalcemia (up to 52%), hyperglycemia (up to 51%), hypoalbuminemia (up to 48%), hyperuricemia (up to 33%), hypomagnesemia (up to 28%), hypermagnesemia (up to 27%), hypophosphatemia (up to 27%), hypokalemia (up to 20%), weight loss (up to 15%), hyponatremia (up to 20%),
Common (1% to 10%): Dehydration, hypoalbuminemia, hyperuricemia, tumor lysis syndrome

Nervous system

Very common (10% or more): Dysgeusia (up to 40%), headache (up to 34%)
Common (1% to 10%): Syncope, dizziness

Hepatic

Very common (10% or more): AST elevations (up to 28%), ALT elevations (up to 22%)
Common (1% to 10%): Hyperbilirubinemia

Dermatologic

Very common (10% or more): Pruritus (up to 31%), dermatitis/exfoliative dermatitis (up to 27%)
Common (1% to 10%): Rash

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Immunologic

Very common (10% or more): Infections (up to 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 (up to 77%), pyrexia (up to 47%), chills (up to 17%)
Common (1% to 10%): Febrile neutropenia

Respiratory

Very common (10% or more): Cough (up to 21%), dyspnea (up to 21%)
Common (1% to 10%): Pulmonary embolism, pneumonitis

Musculoskeletal

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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