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Epirubicin Side Effects

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Common Epirubicin Side Effects


The most commonly reported Epirubicin side effects (click to view or check a box to report):

Neutropenia (87)
Febrile Neutropenia (67)
Pyrexia (65)
Dyspnoea (53)
Nausea (49)
Asthenia (48)
Vomiting (46)
Diarrhoea (45)
Leukopenia (38)
Interstitial Lung Disease (36)
White Blood Cell Count Decreased (34)
Malaise (32)
Mucosal Inflammation (31)
Pneumonia (29)
Fatigue (29)
Cardiac Failure (29)
Neutropenic Sepsis (26)
Erythema (25)
Thrombocytopenia (25)
Haemoglobin Decreased (25)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Epirubicin Side Effects Reported to FDA



Epirubicin Side Effect Report#9993396
Scleroderma, Interstitial Lung Disease, Dyspnoea, Lung Infiltration
This is a report of a 62-year-old male patient (weight: NA) from IE, suffering from the following health symptoms/conditions: oesophageal adenocarcinoma, who was treated with Epirubicin (dosage: NA, start time: NS), combined with:
  • Oxaliplatin
  • Capecitabine
and developed a serious reaction and side effect(s): Scleroderma, Interstitial Lung Disease, Dyspnoea, Lung Infiltration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin treatment in male patients, resulting in Scleroderma side effect.
Epirubicin Side Effect Report#9973402
Lower Respiratory Tract Infection, Sinusitis, Dyspnoea, Asthenia
This report suggests a potential Epirubicin Hcl Lower Respiratory Tract Infection side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: gastrooesophageal cancer and used Epirubicin Hcl (dosage: 104mg (date Of Most Recent Administration 03jul2013)) starting
May 22, 2013. After starting Epirubicin Hcl the patient began experiencing various side effects, including: Lower Respiratory Tract Infection, Sinusitis, Dyspnoea, AstheniaAdditional drugs used concurrently:
  • Cisplatin (125 Mg (date Of Most Recent Administration 07jul2013))
  • Avastin (700 Mg (date Of Most Recent Administration 07jul2013))
  • Xeloda (2500 Mg, Daily (date Of Most Recent Administration 23jul2013))
The patient was hospitalized. Although Epirubicin Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lower Respiratory Tract Infection, may still occur.
Epirubicin Side Effect Report#9940261
Neutropenic Sepsis, Febrile Neutropenia, Tremor, Malaise
This Neutropenic Sepsis problem was reported by a health professional from GB. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Nov 20, 2013 this consumer started treatment with Epirubicin (dosage: Unk). The following drugs were being taken at the same time:
  • 5 Fu (Unk)
  • Cyclophosphamide (Unk)
  • Neulasta (Unk, 3/52)
When using Epirubicin, the patient experienced the following unwanted symptoms/side effects: Neutropenic Sepsis, Febrile Neutropenia, Tremor, MalaiseThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Neutropenic Sepsis, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9929570
Neurotoxicity
This Neurotoxicity side effect was reported by a physician from CN. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Epirubicin Hcl (drug dosage: 80mg,the Cycle Was Repeated Every 21 Days For 6 Cycles.), which was initiated on NS. Concurrently used drugs:
  • Docetaxel (80 Mg, The Cycle Was Repeated Every 21 Days For 6 Cycles.)
.After starting to take Epirubicin Hcl the consumer reported adverse symptoms, such as: NeurotoxicityThese side effects may potentially be related to Epirubicin Hcl.
Epirubicin Side Effect Report#9928743
Supraventricular Extrasystoles
This is a report of a 45-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Epirubicin Hydrochloride (dosage: 1 Unit Dose, Total, start time:
Jan 16, 2014), combined with:
  • Fluorouracil (1 Unit Dose, Total)
  • (cyclophosphamide) (1 Unit Dose, Total)
  • (eutirox)
and developed a serious reaction and side effect(s): Supraventricular Extrasystoles after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin Hydrochloride treatment in female patients, resulting in Supraventricular Extrasystoles side effect.
Epirubicin Side Effect Report#9912998
Fracture, Spinal Fracture, Osteopenia, Pain
This report suggests a potential Epirubicin Fracture side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: breast cancer female and used Epirubicin (dosage: NA) starting 200006. After starting Epirubicin the patient began experiencing various side effects, including: Fracture, Spinal Fracture, Osteopenia, PainAdditional drugs used concurrently:
  • Cyclophosphamide
  • Fluorouracil
  • Adcal (calcium Carbonate)
  • Forsteo (teriparatide)
  • Ketamine
  • Oxycontin (oxycodone)
The patient was hospitalized and became disabled. Although Epirubicin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fracture, may still occur.
Epirubicin Side Effect Report#9912555
Hepatitis Acute, Pruritus
This Hepatitis Acute problem was reported by a health professional from IT. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Nov 08, 2013 this consumer started treatment with Epirubicin Hydrochloride (dosage: Cyclical). The following drugs were being taken at the same time:
  • Fluorouracil (Cyclical)
  • Cyclophosphamide (Cyclical)
When using Epirubicin Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Hepatitis Acute, PruritusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatitis Acute, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9911195
Febrile Neutropenia, Pneumonia Cytomegaloviral, Epstein-barr Virus Infection
This Febrile Neutropenia side effect was reported by a physician from AT. A 71-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Epirubicin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Cyclophosphamide
  • Fluorouracil
  • Docetaxel (75 Mg/m2)
.After starting to take Epirubicin the consumer reported adverse symptoms, such as: Febrile Neutropenia, Pneumonia Cytomegaloviral, Epstein-barr Virus InfectionThese side effects may potentially be related to Epirubicin.
Epirubicin Side Effect Report#9906556
Supraventricular Extrasystoles
This is a report of a 45-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Epirubicin (dosage: NA, start time:
Jan 16, 2014), combined with:
  • Fluorouracil
  • Cyclophosphamide (1 Df Total)
  • Eutirox - 50 Microgrammi Compresse (1 Df)
and developed a serious reaction and side effect(s): Supraventricular Extrasystoles after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin treatment in female patients, resulting in Supraventricular Extrasystoles side effect.
Epirubicin Side Effect Report#9900360
Enterocolitis, Vomiting, Diarrhoea, Febrile Neutropenia, Anaemia, Thrombocytopenia, Blood Electrolytes Abnormal, Presyncope
This report suggests a potential Epirubicin Hcl Enterocolitis side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from CH was diagnosed with the following symptoms/conditions: gastric cancer and used Epirubicin Hcl (dosage: 1 Df, Cyclic (day 1 Of Cycle, Every 21 Days)) starting
Dec 02, 2013. After starting Epirubicin Hcl the patient began experiencing various side effects, including: Enterocolitis, Vomiting, Diarrhoea, Febrile Neutropenia, Anaemia, Thrombocytopenia, Blood Electrolytes Abnormal, PresyncopeAdditional drugs used concurrently:
  • Xeloda (650 Mg, 2x/day)
  • Oxaliplatin (1 Df, Cyclic (day 1 Of Cycle, Every 21 Days))
The patient was hospitalized. Although Epirubicin Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Enterocolitis, may still occur.
Epirubicin Side Effect Report#9898422
Supraventricular Extrasystoles
This Supraventricular Extrasystoles problem was reported by a physician from IT. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer. On
Jan 16, 2014 this consumer started treatment with Epirubicin Hcl (dosage: 1 Df, Single). The following drugs were being taken at the same time:
  • Cyclophosphamide (1 Df, Single)
  • 1-(u-d-5^-deossiribofuranosil)-5-fluorouracil (1 Df, Single)
  • Eutirox (1 Df, Unk)
When using Epirubicin Hcl, the patient experienced the following unwanted symptoms/side effects: Supraventricular ExtrasystolesAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Supraventricular Extrasystoles, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9892225
Asthenia, Chromaturia, Hepatitis Acute, Nausea, Pruritus
This Asthenia side effect was reported by a physician from IT. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Epirubicin Hydrochloride (drug dosage: 110 Mg Cyclical), which was initiated on
Nov 08, 2013. Concurrently used drugs:
  • Fluorouracil (800 Mg Cyclical)
  • Cyclophosphamide (800 Mg Cyclical)
.After starting to take Epirubicin Hydrochloride the consumer reported adverse symptoms, such as: Asthenia, Chromaturia, Hepatitis Acute, Nausea, PruritusThese side effects may potentially be related to Epirubicin Hydrochloride. The patient was hospitalized.
Epirubicin Side Effect Report#9886639
Chromaturia, Asthenia, Nausea, Pruritus
This is a report of a 53-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: breast cancer, who was treated with Epirubicin (dosage: 110 Mg, Cyclic, start time:
Nov 08, 2013), combined with:
  • Cyclophosphamide (800 Mg, Cyclic)
  • Fluorouracil (800 Mg, Cyclic)
and developed a serious reaction and side effect(s): Chromaturia, Asthenia, Nausea, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin treatment in female patients, resulting in Chromaturia side effect. The patient was hospitalized.
Epirubicin Side Effect Report#9882965
Hypoacusis, Photopsia, Headache, Infusion Site Nerve Damage, Pain, Arthralgia
This report suggests a potential Epirubicin Hypoacusis side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: breast cancer female and used Epirubicin (dosage: NA) starting
Dec 10, 2010. After starting Epirubicin the patient began experiencing various side effects, including: Hypoacusis, Photopsia, Headache, Infusion Site Nerve Damage, Pain, ArthralgiaAdditional drugs used concurrently: NA. Although Epirubicin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoacusis, may still occur.
Epirubicin Side Effect Report#9880801
Photopsia, Hypoacusis, Arthralgia, Headache, Toxicity To Various Agents, Grip Strength Decreased, Infusion Site Nerve Damage
This Photopsia problem was reported by a health professional from GB. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breast cancer female. On
Dec 10, 2010 this consumer started treatment with Epirubicin Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Docetaxel
  • Cyclophosphamide
  • Trastuzumab
  • Prednisolone
  • Anastrozole
  • Fluticasone Propionate W/salmeterol Xinafoate
When using Epirubicin Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Photopsia, Hypoacusis, Arthralgia, Headache, Toxicity To Various Agents, Grip Strength Decreased, Infusion Site Nerve DamageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Photopsia, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9870338
Memory Impairment, Disturbance In Attention, Arthralgia, Periodontitis, Asthenia, Motor Dysfunction, Osteoporosis, Fatigue, Muscle Atrophy
This Memory Impairment side effect was reported by a consumer or non-health professional from DK. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Epirubicin (drug dosage: NA), which was initiated on
Mar 29, 2005. Concurrently used drugs:
  • Cyclophosphamide
  • Fluorouracil
  • Tamoxifen
  • Arimidex
.After starting to take Epirubicin the consumer reported adverse symptoms, such as: Memory Impairment, Disturbance In Attention, Arthralgia, Periodontitis, Asthenia, Motor Dysfunction, Osteoporosis, Fatigue, Muscle AtrophyThese side effects may potentially be related to Epirubicin.
Epirubicin Side Effect Report#9869506
Photopsia, Headache, Hypoacusis, Infusion Site Nerve Damage, Pain, Arthralgia
This is a report of a 61-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: breast cancer female, who was treated with Epirubicin (dosage: NA, start time:
Dec 10, 2010), combined with:
  • Cyclophosphamide
  • Docetaxel
  • Herceptin
  • Prednisolone
  • Arimidex
  • Seretide
and developed a serious reaction and side effect(s): Photopsia, Headache, Hypoacusis, Infusion Site Nerve Damage, Pain, Arthralgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin treatment in female patients, resulting in Photopsia side effect.
Epirubicin Side Effect Report#9856451
Cerebral Infarction, Hemiparesis, White Blood Cell Count Abnormal, Neutrophil Count Abnormal, Hemianopia Homonymous, Lower Respiratory Tract Infection, Respiratory Failure, Carotid Artery Occlusion, Somnolence
This report suggests a potential Epirubicin Cerebral Infarction side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: breast cancer,prophylaxis and used Epirubicin (dosage: 160 Milligram Daily;) starting
Dec 31, 2013. After starting Epirubicin the patient began experiencing various side effects, including: Cerebral Infarction, Hemiparesis, White Blood Cell Count Abnormal, Neutrophil Count Abnormal, Hemianopia Homonymous, Lower Respiratory Tract Infection, Respiratory Failure, Carotid Artery Occlusion, SomnolenceAdditional drugs used concurrently:
  • Neulasta (6 Milligram Daily; 6 Mg, Once)
  • Fluorouracil (800 Milligram Daily;)
  • Cyclophosphamide (800 Milligram Daily;)
The patient was hospitalized. Although Epirubicin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebral Infarction, may still occur.
Epirubicin Side Effect Report#9849927
Extravasation, Wound Decomposition
This Extravasation problem was reported by a health professional from GB. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Sep 07, 2012 this consumer started treatment with Epirubicin (dosage: NA). The following drugs were being taken at the same time: NA. When using Epirubicin, the patient experienced the following unwanted symptoms/side effects: Extravasation, Wound DecompositionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extravasation, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9849884
Cerebral Infarction, Hemiparesis, Hemianopia Homonymous, White Blood Cell Count Abnormal, Neutrophil Count Abnormal, Lower Respiratory Tract Infection, Respiratory Failure, Carotid Artery Occlusion, Somnolence
This Cerebral Infarction side effect was reported by a physician from GB. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Epirubicin Hcl (drug dosage: 160 Mg, 1x/day), which was initiated on
Jan 01, 2014. Concurrently used drugs:
  • Fluorouracil (800 Mg, 1x/day)
  • Cyclophosphamide (800 Mg, 1x/day)
  • Neulasta (6 Mg, Once)
.After starting to take Epirubicin Hcl the consumer reported adverse symptoms, such as: Cerebral Infarction, Hemiparesis, Hemianopia Homonymous, White Blood Cell Count Abnormal, Neutrophil Count Abnormal, Lower Respiratory Tract Infection, Respiratory Failure, Carotid Artery Occlusion, SomnolenceThese side effects may potentially be related to Epirubicin Hcl. The patient was hospitalized.
Epirubicin Side Effect Report#9828608
Infusion Related Reaction, Rash, Burning Sensation, Chills
This is a report of a 38-year-old female patient (weight: NA) from SI, suffering from the following health symptoms/conditions: breast cancer, who was treated with Epirubicin (dosage: 160 Mg, Total, start time:
Jun 27, 2013), combined with:
  • 5-fluorouracil /00098801/ (Unk)
  • Granisetron (Unk)
and developed a serious reaction and side effect(s): Infusion Related Reaction, Rash, Burning Sensation, Chills after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin treatment in female patients, resulting in Infusion Related Reaction side effect.
Epirubicin Side Effect Report#9827325
Extravasation, Wound Decomposition
This report suggests a potential Epirubicin Hcl Extravasation side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: NA and used Epirubicin Hcl (dosage: 200 Mg, On-going For Three Weeks) starting
Sep 07, 2012. After starting Epirubicin Hcl the patient began experiencing various side effects, including: Extravasation, Wound DecompositionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Epirubicin Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Extravasation, may still occur.
Epirubicin Side Effect Report#9822699
Diarrhoea, Mucosal Inflammation
This Diarrhoea problem was reported by a physician from NL. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: gastric cancer. On
Nov 26, 2013 this consumer started treatment with Epirubicin (dosage: NA). The following drugs were being taken at the same time:
  • Capecitabine
  • Itraconazol
  • Loperamide
  • Metoclopramide
When using Epirubicin, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Mucosal InflammationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Epirubicin Side Effect Report#9814409
Enterocolitis Haemorrhagic
This Enterocolitis Haemorrhagic side effect was reported by a physician from IT. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer.The patient was prescribed Epirubicin Hydrochloride (drug dosage: 120 Mg Cyclical), which was initiated on
Oct 02, 2013. Concurrently used drugs:
  • Cyclophosphamide (950 Milligram Daily;)
  • Zestril
  • Sinvacor
  • Eutirox
  • Antra
.After starting to take Epirubicin Hydrochloride the consumer reported adverse symptoms, such as: Enterocolitis HaemorrhagicThese side effects may potentially be related to Epirubicin Hydrochloride.
Epirubicin Side Effect Report#9804074
Neonatal Respiratory Distress Syndrome, Hypospadias, Pulmonary Artery Stenosis Congenital
This is a report of a male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: breast cancer, who was treated with Epirubicin Hydrochloride (dosage: 156 Mg/ Twice During Pregn. 14.9 And 05.10., start time:
Feb 11, 2012), combined with:
  • Cyclophosphamide (1040 Mg/twice During Pregn. 14.9. And 05.10.)
  • Lamotrigin (300 Mg/d/begin Of Pregn: 2x50 Mg; In The End 2x50 Mg)
  • Folic Acid
  • Filgrastim
  • Dexamethasone
  • Ondansetron
and developed a serious reaction and side effect(s): Neonatal Respiratory Distress Syndrome, Hypospadias, Pulmonary Artery Stenosis Congenital after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epirubicin Hydrochloride treatment in male patients, resulting in Neonatal Respiratory Distress Syndrome side effect. The patient was hospitalized.


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The appearance of Epirubicin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Epirubicin Side Effects for Women?

Women Side EffectsReports
Neutropenia 72
Febrile Neutropenia 57
Pyrexia 46
Asthenia 37
Dyspnoea 36
Nausea 36
Vomiting 33
Cardiac Failure 27
Leukopenia 27
White Blood Cell Count Decreased 25

What are common Epirubicin Side Effects for Men?

Men Side EffectsReports
Diarrhoea 27
Malaise 19
Pyrexia 15
Neutropenia 14
Mucosal Inflammation 13
Vomiting 13
Bladder Perforation 12
Cellulitis 12
Dyspnoea 12
Interstitial Lung Disease 12

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  • Log Form

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Epirubicin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Epirubicin Safety Alerts, Active Ingredients, Usage Information

    NDC0703-3067
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameEpirubicin Hydrochloride
    NameEpirubicin Hydrochloride
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVENOUS
    On market since20070809
    LabelerTeva Parenteral Medicines, Inc.
    Active Ingredient(s)EPIRUBICIN HYDROCHLORIDE
    Strength(s)50
    Unit(s)mg/25mL
    Pharma ClassAnthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [Chemical/Ingredient],Topoisomerase Inhib

    More About Epirubicin

    Side Effects reported to FDA: 1141

    Epirubicin safety alerts: No

    Reported deaths: 76

    Reported hospitalizations: 267

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