Ellence Side Effects
Generic name: epirubicin
Medically reviewed by Drugs.com. Last updated on Apr 14, 2025.
Note: This document provides detailed information about Ellence Side Effects associated with epirubicin. Some dosage forms listed on this page may not apply specifically to the brand name Ellence.
Applies to epirubicin: intravenous solution.
Important warnings
This medicine can cause some serious health issues
Intravenous route (solution)
Myocardial damage, including acute left ventricular failure, can occur with epirubicin.
The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 0.9% at a cumulative dose of 550 mg/m(2), 1.6% at 700 mg/m(2), and 3.3% at 900 mg/m(2) and is further increased with concomitant cardiotoxic therapy.
Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with epirubicin.
Secondary acute myelogenous leukemia and myelodysplastic syndrome occur at a higher incidence in patients treated with anthracyclines, including epirubicin. Extravasation of epirubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.
Immediately terminate the drug and apply ice to the affected area.
Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before starting this medicine to make sure you are not pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. Male patients with pregnant partners should use condoms during treatment and for at least 7 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Your doctor may monitor your heart before you start receiving epirubicin (the active ingredient contained in Ellence) and while you are getting treatments with this medicine. Call your doctor right away if you have any chest pain, increased coughing, trouble breathing, a sudden difficulty with breathing at night, rapid weight gain, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems.
This medicine should not be used within 24 weeks of stopping trastuzumab (Herceptin) unless your doctor has determined that it is the best treatment.
This medicine can rarely cause leukemia (cancer of the blood). Talk with your doctor if you have concerns about this.
While you are being treated with epirubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Epirubicin may lower your body's resistance, and there is a chance you might get the infection the immunization is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them, and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Epirubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
- If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
- Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
- Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
- Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
- Avoid contact sports or other situations where bruising or injury could occur.
If epirubicin accidentally leaks out of the vein into which it is injected, it may damage some tissues and may cause scarring. Tell the doctor right away if you notice redness, pain, or swelling at the injection site.
This medicine may cause a serious type of reaction called tumor lysis syndrome. Your doctor may give you a medicine to help prevent this. Call your doctor right away if you have a decrease or change in urine amount, joint pain, stiffness, or swelling, lower back, side, or stomach pain, a rapid weight gain, swelling of the feet or lower legs, or unusual tiredness or weakness.
This medicine may increase your risk of developing blood clots. If you have chest pain, trouble breathing, or pain, redness, or swelling in your arms or legs while using this medicine, call your doctor right away.
This medicine may turn your urine red for 1 or 2 days after your treatment. This is normal and is nothing to worry about. You may want to protect your clothing from being stained.
This medicine often causes a temporary and total loss of hair. After treatment with epirubicin has ended, normal hair growth should return.
Cancer medicines can cause nausea and vomiting, in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects if you still have nausea or vomiting after receiving the medicine.
If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Ellence
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 side effects
- 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 side effects
- blood in the urine or stools
- pinpoint red spots on the skin
- red streaks along the injected vein
Rare side effects
- 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 Ellence
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 side effects
- 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 side effects
- changes in the skin
- loss of appetite
- weight loss
Rare side effects
- darkening of the soles, palms, or nails
For healthcare professionals
Applies to epirubicin: intravenous powder for injection, intravenous solution.
Hematologic adverse events
- 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]
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References
1. (2001) "Product Information. Ellence (epirubicin)." Pharmacia and Upjohn
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Ellence side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.