EPIRUBICIN HYDROCHLORIDE

N/A

Manufactured by Pharmacia & Upjohn Company LLC

10,973 FDA adverse event reports analyzed

Last updated: 2026-04-15

About EPIRUBICIN HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. The most commonly reported adverse reactions for EPIRUBICIN HYDROCHLORIDE include MYELOSUPPRESSION, NAUSEA, ALOPECIA, WHITE BLOOD CELL COUNT DECREASED, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EPIRUBICIN HYDROCHLORIDE.

Top Adverse Reactions

MYELOSUPPRESSION614 reports
NAUSEA510 reports
ALOPECIA455 reports
WHITE BLOOD CELL COUNT DECREASED451 reports
VOMITING388 reports
FEBRILE NEUTROPENIA357 reports
PYREXIA305 reports
ASTHENIA296 reports
NEUTROPENIA270 reports
NEUTROPHIL COUNT DECREASED242 reports
HEPATIC FUNCTION ABNORMAL238 reports
DIARRHOEA218 reports
OFF LABEL USE215 reports
FATIGUE177 reports
PSYCHOLOGICAL TRAUMA174 reports
DECREASED APPETITE166 reports
PAIN157 reports
ANAEMIA153 reports
PLATELET COUNT DECREASED144 reports
NEOPLASM PROGRESSION141 reports
DYSPNOEA125 reports
LEUKOPENIA112 reports
ANXIETY111 reports
HAIR TEXTURE ABNORMAL109 reports
HAIR COLOUR CHANGES108 reports
CARDIAC FAILURE107 reports
EMOTIONAL DISTRESS104 reports
BONE MARROW FAILURE102 reports
HAIR DISORDER102 reports
MADAROSIS102 reports
THROMBOCYTOPENIA102 reports
HEADACHE100 reports
MALIGNANT NEOPLASM PROGRESSION97 reports
INTERSTITIAL LUNG DISEASE95 reports
DIZZINESS92 reports
NEUROPATHY PERIPHERAL92 reports
GASTROINTESTINAL DISORDER91 reports
ABDOMINAL PAIN88 reports
PNEUMONIA84 reports
DEHYDRATION83 reports
DEATH81 reports
AGRANULOCYTOSIS80 reports
LIVER INJURY77 reports
PANCYTOPENIA77 reports
DRUG INDUCED LIVER INJURY75 reports
BACK PAIN74 reports
CONSTIPATION74 reports
DISEASE PROGRESSION74 reports
RASH73 reports
HYPOAESTHESIA70 reports
DYSPHAGIA68 reports
IMPAIRED QUALITY OF LIFE68 reports
CARDIAC FAILURE CONGESTIVE67 reports
PARAESTHESIA66 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME65 reports
SEPSIS65 reports
CONDITION AGGRAVATED64 reports
HAEMOGLOBIN DECREASED64 reports
INFECTION64 reports
ALANINE AMINOTRANSFERASE INCREASED62 reports
ASPARTATE AMINOTRANSFERASE INCREASED61 reports
MALAISE61 reports
GRANULOCYTE COUNT DECREASED60 reports
CARDIOTOXICITY59 reports
DRUG INEFFECTIVE58 reports
EJECTION FRACTION DECREASED56 reports
CHEST DISCOMFORT55 reports
COUGH55 reports
BREAST CANCER54 reports
PULMONARY EMBOLISM54 reports
ARTHRALGIA52 reports
METASTASES TO LIVER51 reports
SECOND PRIMARY MALIGNANCY51 reports
CHEST PAIN50 reports
METASTASES TO BONE50 reports
HEPATIC FAILURE49 reports
PALPITATIONS49 reports
DRUG INTOLERANCE48 reports
ERYTHEMA48 reports
MYALGIA48 reports
HYPOKALAEMIA46 reports
WEIGHT DECREASED46 reports
MUCOSAL INFLAMMATION45 reports
BREAST CANCER METASTATIC43 reports
HYPONATRAEMIA43 reports
PLEURAL EFFUSION43 reports
SEPTIC SHOCK43 reports
C REACTIVE PROTEIN INCREASED42 reports
GENERAL PHYSICAL HEALTH DETERIORATION42 reports
STOMATITIS42 reports
DISCOMFORT41 reports
ACUTE MYELOID LEUKAEMIA40 reports
HYPERSENSITIVITY40 reports
PAIN IN EXTREMITY40 reports
TRANSAMINASES INCREASED39 reports
CARDIOMYOPATHY38 reports
LYMPHOCYTE COUNT DECREASED37 reports
RHINORRHOEA37 reports
HYPOTENSION36 reports
PERIPHERAL SWELLING36 reports

Report Outcomes

Out of 6,014 classified reports for EPIRUBICIN HYDROCHLORIDE:

Serious 96.6%Non-Serious 3.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female4,790 (85.5%)
Male798 (14.2%)
Unknown15 (0.3%)

Reports by Age

Age 52191 reports
Age 50174 reports
Age 51162 reports
Age 57155 reports
Age 53150 reports
Age 60147 reports
Age 70143 reports
Age 56136 reports
Age 62136 reports
Age 58135 reports
Age 49132 reports
Age 65131 reports
Age 54130 reports
Age 55126 reports
Age 48123 reports
Age 67119 reports
Age 59116 reports
Age 63116 reports
Age 61114 reports
Age 44112 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with EPIRUBICIN HYDROCHLORIDE?

This profile reflects 10,973 FDA FAERS reports that mention EPIRUBICIN HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for EPIRUBICIN HYDROCHLORIDE?

Frequently reported terms in FAERS include MYELOSUPPRESSION, NAUSEA, ALOPECIA, WHITE BLOOD CELL COUNT DECREASED, VOMITING, FEBRILE NEUTROPENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures EPIRUBICIN HYDROCHLORIDE?

Labeling and FAERS entries often list Pharmacia & Upjohn Company LLC in connection with EPIRUBICIN HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.