Epirubicin Side Effects

Some side effects of epirubicin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to epirubicin: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking epirubicin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have:

• feeling short of breath, even with mild exertion;

• swelling, rapid weight gain (especially in your face and midsection);

• irritation or skin changes where the injection was given;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fast, slow, or uneven heartbeats;

• anxiety, sweating, severe shortness of breath, wheezing, gasping for breath;

• chest pain, sudden cough, cough with foamy mucus, rapid breathing, coughing up blood;

• lower back pain, blood in your urine, little or no urinating;

• numbness or tingly feeling around your mouth, weak pulse, overactive reflexes, confusion, fainting;

• muscle weakness, tightness, or contraction;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat; or

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Common side effects may include:

• hot flashes, missed menstrual periods;

• temporary hair loss;

• feeling weak or tired;

• mild nausea, diarrhea; or

• eye redness, puffy eyelids.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to epirubicin: intravenous powder for injection, intravenous solution

Hematologic

Hematologic effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include leukopenia (up to 80.3%), neutropenia (up to 80.3%), anemia (up to 72.2%), and thrombocytopenia (up to 48.4%). Long-term hematologic effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include acute myelogenous leukemia (up to 0.8%). Postmarketing side effects have included hemorrhage.

Endocrine

Endocrine effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include amenorrhea (up to 71.8%) and hot flashes (up to 38.9%).

General

General effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include lethargy (up to 45.8%) and fever (up to 5.2%). Postmarketing reports have included sepsis, shock, fever and chills.

Gastrointestinal

The mucositis is dose-dependent. Clinical manifestations of mucositis may include a painful or burning sensation, erythema, erosions, ulcerations, bleeding, or infections.

Gastrointestinal effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include nausea/vomiting (up to 92.4%), mucositis (up to 58.5%), diarrhea (up to 24.8%), and anorexia (up to 2.9%). Abdominal pain and hyperpigmentation of the oral mucosa has also been reported. Postmarketing side effects have included erosions, ulcerations, pain or burning sensation, bleeding, and hyperpigmentation of the oral mucosa.

Immunologic

Immunologic effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include infection (up to 21.5%) and febrile neutropenia (up to 6.1%).

Ocular

Ocular effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include conjunctivitis/keratitis (up to 14.8%).

Dermatologic

Dermatologic effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include alopecia (up to 95.5%), rash/itch (up to 8.9%) and skin changes (up to 4.7%). Postmarketing side effects have included erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), and urticaria.

Alopecia has been reported to usually be reversible. Hair growth may occur within two to three months after therapy is discontinued.

Cardiovascular

Long-term cardiovascular effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have included asymptomatic drops in LVEF (up to 1.8%) and CHF (up to 1.5%). One large retrospective study reported a significantly increased risk of CHF in patients who received cumulative doses greater than 950 mg/m2. The study also found that previous irradiation against the heart leads to an increased risk of developing CHF with an accelerated course to death. This indicates an additive cardiotoxic effect with the use of irradiation and epirubicin. Other serious drug-related cardiovascular adverse events that occurred during clinical trials have included ventricular tachycardia, AV block, bundle branch block, bradycardia and thromboembolism. Postmarketing side effects have included arterial embolism, thrombophlebitis, and phlebitis.

Respiratory

Respiratory side effects have included postmarketing reports of pneumonia and pulmonary embolism.

Hypersensitivity

Hypersensitivity side effects have included postmarketing reports of anaphylaxis.

Metabolic

Metabolic side effects have included postmarketing reports of dehydration and hyperuricemia.

Genitourinary

Genitourinary side effects have included postmarketing reports of red coloration of urine for 1 to 2 days after administration and chemical cystitis (following intravesical administration).

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