Pharmorubicin PFS Side Effects

Generic Name: epirubicin

Please note - some side effects for Pharmorubicin PFS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects by Body System

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%).

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%).

Gastrointestinal

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.

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

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%).

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.

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