Ellence Side Effects Center

Last updated on RxList: 12/9/2021
Ellence Side Effects Center

What Is Ellence?

Ellence (epirubicin hydrochloride) is used to treat breast cancer. It is a cancer (antineoplastic) medication. Ellence is available in generic form.

What Are Side Effects of Ellence?

Common side effects of Ellence include:

Dosage for Ellence

The recommended dose of Ellence is 100 to 120 mg/m², administered by intravenous infusion, given in repeated 3- to 4-week cycles. The total dose may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle.

What Drugs, Substances, or Supplements Interact with Ellence?

Ellence may interact with paclitaxel, docetaxel, cimetidine, or calcium channel blockers. Tell your doctor all medications and supplements you use.

Ellence During Pregnancy and Breastfeeding

Ellence is not recommended for use during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Males and females using this drug should use birth control (e.g., birth control pills, condoms) during treatment; consult your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Ellence (epirubicin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


A lump in the breast is almost always cancer. See Answer
Ellence Consumer Information

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

Epirubicin can cause dangerous effects on your heart that may not be reversible and could occur months to years after you receive epirubicin. Call your doctor right away if you have symptoms of heart problems: swelling, rapid weight gain, shortness of breath.

Also call your doctor at once if you have:

  • fast or slow heartbeats;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • pain, blistering, redness, bruising, or skin changes where the injection was given;
  • severe vomiting;
  • dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
  • fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats;
  • signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth; or
  • signs of infection--fever, chills, flu symptoms, mouth sores, shallow breathing, pale or blue-colored skin.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • temporary hair loss;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • hot flashes, missed menstrual periods;
  • discoloration of your skin or nails;
  • lack of energy; or
  • red-colored urine for 1 or 2 days after each injection.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ellence (Epirubicin hydrochloride)


Breast Cancer Awareness: Symptoms, Diagnosis, and Treatment See Slideshow
Ellence Professional Information


The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Cardiac Toxicity [see WARNINGS AND PRECAUTIONS]
  • Secondary Malignancies [see WARNINGS AND PRECAUTIONS]
  • Extravasation and Tissue Necrosis [see WARNINGS AND PRECAUTIONS]
  • Severe Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Tumor-Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Thrombophlebitis and Thromboembolic Events [see WARNINGS AND PRECAUTIONS]
  • Potentiation of Radiation Toxicity and Radiation Recall [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ELLENCE was evaluated in two studies (Studies MA-5 and GFEA-05) evaluating combination regimens in patients with early breast cancer [see Clinical Studies]. Of the 1260 patients treated in these studies, 620 patients received the higher-dose ELLENCE regimen (FEC-100/CEF-120), 280 patients received the lower-dose ELLENCE regimen (FEC-50), and 360 patients received CMF. Serotonin-specific antiemetic therapy and colony-stimulating factors were not used in these trials. Clinically relevant adverse reactions are summarized in Table 1.

Table 1. Adverse Reactions in Patients with Early Breast Cancer

Event% of Patients
Grades 1-4Grades 3/4Grades 1-4Grades 3/4Grades 1-4Grades 3/4
  Hot flashes.39450696
Body as a Whole
  Febrile neutropeniaNA600NA1.1
  Local toxicity200.32.50.480
  Skin changes4.700.7070
FEC & CEF = cyclophosphamide + ELLENCE + fluorouracil; CMF = cyclophosphamide + methotrexate + fluorouracil; NA = not available Grade 1 or 2 changes in transaminase levels were observed but were more frequently seen with CMF than with CEF.

Delayed Events

Table 2 describes the incidence of delayed adverse reactions in patients participating in the MA-5 and GFEA-05 trials.

Table 2. Long-Term Adverse Reactions in Patients with Early Breast Cancer

Event% of Patients
Cardiac events
Asymptomatic drops in LVEF2.1*1.40.8*
*In study MA-5, cardiac function was not monitored after 5 years.
Two cases of acute lymphoid leukemia (ALL) were also observed in patients receiving ELLENCE. However, an association between anthracyclines such as ELLENCE and ALL has not been clearly established.


Dose-dependent, reversible leukopenia and/or neutropenia is the predominant manifestation of hematologic toxicity associated with ELLENCE and represents the most common acute dose-limiting toxicity of this drug. In most cases, the white blood cell (WBC) nadir is reached 10 to 14 days from drug administration. Leukopenia/neutropenia is usually transient, with WBC and neutrophil counts generally returning to normal values by Day 21 after drug administration. As with other cytotoxic agents, ELLENCE at the recommended dose in combination with cyclophosphamide and fluorouracil can produce severe leukopenia and neutropenia. Severe thrombocytopenia and anemia may also occur. Clinical consequences of severe myelosuppression include fever, infection, septicemia, septic shock, hemorrhage, tissue hypoxia, symptomatic anemia, or death. If myelosuppressive complications occur, use appropriate supportive measures (e.g., intravenous antibiotics, colony-stimulating factors, transfusions). Myelosuppression requires careful monitoring. Assess total and differential WBC, red blood cell (RBC), and platelet counts before and during each cycle of therapy with ELLENCE [see WARNINGS AND PRECAUTIONS].


A dose-dependent mucositis (mainly oral stomatitis, less often esophagitis) may occur in patients treated with ELLENCE. Clinical manifestations of mucositis may include a pain or burning sensation, erythema, erosions, ulcerations, bleeding, or infections. Mucositis generally appears early after drug administration and, if severe, may progress over a few days to mucosal ulcerations; most patients recover from this adverse event by the third week of therapy. Hyperpigmentation of the oral mucosa may also occur. Nausea, vomiting, and occasionally diarrhea and abdominal pain can also occur. Severe vomiting and diarrhea may produce dehydration. Antiemetics may reduce nausea and vomiting; consider prophylactic use of antiemetics before therapy [see DOSAGE AND ADMINISTRATION].

Cutaneous and Hypersensitivity Reactions

Alopecia occurs frequently, but is usually reversible, with hair regrowth occurring within 2 to 3 months from the termination of therapy. Flushes, skin and nail hyperpigmentation, photosensitivity, and hypersensitivity to irradiated skin (radiation-recall reaction) have been observed. Urticaria and anaphylaxis have been reported in patients treated with ELLENCE; signs and symptoms of these reactions may vary from skin rash and pruritus to fever, chills, and shock.


Serious drug-related cardiovascular adverse events that occurred during clinical trials with ELLENCE, administered in different indications, include ventricular tachycardia, AV block, bundle branch block, bradycardia and thromboembolism.

Secondary Leukemia

An analysis of 7110 patients who received adjuvant treatment with ELLENCE in controlled clinical trials as a component of poly-chemotherapy regimens for early breast cancer, showed a cumulative risk of secondary acute myelogenous leukemia or myelodysplastic syndrome (AML/MDS) of about 0.27% (approximate 95% CI, 0.14-0.40) at 3 years, 0.46% (approximate 95% CI, 0.28-0.65) at 5 years, and 0.55% (approximate 95% CI, 0.33-0.78) at 8 years. The risk of developing AML/MDS increased with increasing ELLENCE cumulative doses as shown in Figure 2.

Figure 2. Risk of AML/MDS in 7110 Patients Treated with ELLENCE

Risk of AML/MDS in 7110 Patients Treated with ELLENCE - Illustration

The cumulative probability of developing AML/MDS was found to be particularly increased in patients who received more than the maximum recommended cumulative dose of ELLENCE (720 mg/m2) or cyclophosphamide (6,300 mg/m2), as shown in Table 3.

Table 3. Cumulative Probability of AML/MDS in Relation to Cumulative Doses of ELLENCE and Cyclophosphamide

Years from Treatment StartCumulative Probability of Developing AML/MDS % (95% CI)
Cyclophosphamide Cumulative Dose ≤6,300 mg/m2Cyclophosphamide Cumulative Dose >6,300 mg/m2
ELLENCE Cumulative Dose ≤720 mg/m2
ELLENCE Cumulative Dose >720 mg/m2
ELLENCE Cumulative Dose ≤720 mg/m2
ELLENCE Cumulative Dose >720 mg/m2
30.12 (0.01-0.22)0.00 (0.00-0.00)0.12 (0.00-0.37)4.37 (1.69-7.05)
50.25 (0.08-0.42)2.38 (0.00-6.99)0.31 (0.00-0.75)4.97 (2.06-7.87)
80.37 (0.13-0.61)2.38 (0.00-6.99)0.31 (0.00-0.75)4.97 (2.06-7.87)

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of ELLENCE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Infections and infestations: sepsis, pneumonia

Immune system disorders: anaphylaxis

Metabolism and nutrition disorders: dehydration, hyperuricemia

Vascular disorders: shock, hemorrhage, embolism arterial, thrombophlebitis, phlebitis

Respiratory, thoracic and mediastinal disorders: pulmonary embolism

Gastrointestinal disorders: erosions, ulcerations, pain or burning sensation, bleeding, hyperpigmentation of the oral mucosa

Skin and subcutaneous tissue disorders: erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction), urticaria

Renal and urinary disorders: red coloration of urine for 1 to 2 days after administration

General disorders and administration site conditions: fever, chills

Injury, poisoning and procedural complications: chemical cystitis (following intravesical administration)

Read the entire FDA prescribing information for Ellence (Epirubicin hydrochloride)

© Ellence Patient Information is supplied by Cerner Multum, Inc. and Ellence Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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