Epirubicin Side Effects
Not all side effects for epirubicin 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 epirubicin: intravenous powder for solution, intravenous solution
In addition to its needed effects, some unwanted effects may be caused by epirubicin. In the event that any of these side effects do occur, they may require medical attention.
Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.
If any of the following side effects occur while taking epirubicin, check with your doctor or nurse immediately:More common
- Black, tarry stools
- bleeding, redness, or ulcers in the mouth or throat
- chest pain
- cough or hoarseness
- fever or chills
- lower back or side pain
- pain or burning in the mouth or throat
- painful or difficult urination
- shortness of breath
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- Blood in the urine or stools
- pinpoint red spots on the skin
- red streaks along the injected vein
- Darkening or redness of the skin at place of irradiation
- difficulty with breathing
- fast or irregular heartbeat
- joint pain
- pain, redness, or warmth at the injection site
- skin rash or itching
- swelling of the abdomen or stomach, lower legs, and feet
- swelling or tenderness of the lymph nodes, abdomen, side or lower back
If any of the following symptoms of overdose occur while taking epirubicin, get emergency help immediately:Symptoms of overdose
- Abdominal or stomach swelling or tenderness
- high fever
- stomach pain
- swelling of the lining of the mouth, nose, or throat
Some of the side effects that can occur with epirubicin 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
- Absent, missed, or irregular menstrual periods
- burning, dry, or itching eyes
- discharge or excessive tearing
- feeling of warmth
- hair loss or thinning of the hair
- redness of the face, neck, arms, and occasionally, upper chest
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- stopping of menstrual bleeding
- sudden sweating
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Changes in the skin
- loss of appetite
- weight loss
- Darkening of the soles, palms, or nails
After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:
- Fast or irregular heartbeat
- shortness of breath
- swelling of the abdomen or stomach, feet, and lower legs
For Healthcare Professionals
Applies to epirubicin: intravenous powder for injection, intravenous solution
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 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 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 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.
The mucositis is dose-dependent. Clinical manifestations of mucositis may include a painful or burning sensation, erythema, erosions, ulcerations, bleeding, or infections.
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 effects of epirubicin when used in combination chemotherapy with cyclophosphamide and fluorouracil have been reported to include conjunctivitis/keratitis (up to 14.8%).
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.
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 side effects have included postmarketing reports of pneumonia and pulmonary embolism.
Hypersensitivity side effects have included postmarketing reports of anaphylaxis.
Metabolic side effects have included postmarketing reports of dehydration and hyperuricemia.
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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