Applies to epirubicin: intravenous solution.

Serious side effects of Epirubicin

Along with its needed effects, epirubicin 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 epirubicin:

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
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blood in the urine or stools
• pinpoint red spots on the skin
• red streaks along the injected vein

Rare

• Darkening or redness of the skin at the place of irradiation
• 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

Get emergency help immediately if any of the following symptoms of overdose occur while taking epirubicin:

Symptoms of overdose

• Abdominal or stomach swelling or tenderness
• high fever
• stomach pain
• swelling of the lining of the mouth, nose, or throat
• vomiting

Other side effects of Epirubicin

Some side effects of epirubicin 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

• Absent, missed, or irregular menstrual periods
• burning, dry, or itching eyes
• diarrhea
• discharge or excessive tearing
• feeling of warmth
• hair loss or thinning of the hair
• nausea
• 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

Less common

• Changes in the skin
• loss of appetite
• weight loss

Rare

• Darkening of the soles, palms, or nails

For Healthcare Professionals

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

Hematologic

Very common (10% or more): Leukopenia (80%), neutropenia (80%), anemia (72%), thrombocytopenia (49%)

Frequency not reported: Myelosuppression, febrile neutropenia, pancytopenia^[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (92%), mucositis (59%), diarrhea (25%), stomatitis

Common (1% to 10%): GI pain, GI erosion, GI ulcer

Uncommon (0.1% to 1%): GI hemorrhage

Frequency not reported: Abdominal discomfort, esophagitis

Postmarketing reports: Ulceration, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa^[Ref]

Immunologic

Very common (10% or more): Infection (22%)

Frequency not reported: Secondary infection

Postmarketing reports: Sepsis, pneumonia^[Ref]

Ocular

Very common (10% or more): Conjunctivitis/keratitis (15%)^[Ref]

Dermatologic

Very common (10% or more): Alopecia (96%), skin toxicity

Common (1% to 10%): Rash, itching, skin changes, pruritus, nail pigmentation, skin disorder, skin/nail hyperpigmentation

Uncommon (0.1% to 1%): Erythema, urticaria

Frequency not reported: Tissue hypoxia

Postmarketing reports: Flushes, photosensitivity reaction, hypersensitivity to irradiated skin (radiation-recall reaction)^[Ref]

Cardiovascular

Very common (10% or more): Hot flashes (39%)

Common (1% to 10%): Asymptomatic drops in left ventricular ejection fraction (LVEF), cardiac heart failure (CHF), ventricular tachycardia, atrioventricular block, bundle branch block, bradycardia, congestive heart failure

Frequency not reported: Transient ECG changes (including low QRS voltage), arrhythmia, T wave flattening, ST depression, T inversion, cardiomyopathy, venous sclerosis

Postmarketing reports: Shock, hemorrhage, embolism arterial, thrombophlebitis, phlebitis^[Ref]

Respiratory

Postmarketing reports: Pulmonary embolism^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis^[Ref]

Metabolic

Postmarketing reports: Dehydration, hyperuricemia^[Ref]

Genitourinary

Very common (10% or more): Amenorrhea (72%), chromaturia (red coloration of urine for 1 to 2 days after administration)

Frequency not reported: Azoospermia

Postmarketing reports: Chemical cystitis (following intravesical administration)^[Ref]

Local

Very common (10% or more): Local toxicity (20%)

Frequency not reported: Erythematous streaking along the infused vein^[Ref]

Psychiatric

Frequency not reported: Confusion, depression^[Ref]

Hepatic

Very common (10% or more): Transaminases abnormal^[Ref]

Oncologic

Uncommon (0.1% to 1%): Acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL)^[Ref]

Other

Very common (10% or more): Lethargy (46%), malaise, pyrexia

Common (1% to 10%): Fever

Frequency not reported: Weakness

Postmarketing reports: Chills^[Ref]