Drug
Epirubicin Hydrochloride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Myelosuppression | 695 | 69.0 | 77.4 | signal |
| 2 | Madarosis | 102 | 29.1 | 29.6 | signal |
| 3 | Hair Colour Changes | 108 | 28.7 | 29.1 | signal |
| 4 | Hair Texture Abnormal | 109 | 27.0 | 27.4 | signal |
| 5 | Hepatic Function Abnormal | 263 | 23.7 | 24.6 | signal |
| 6 | Neutrophil Count Decreased | 263 | 21.6 | 22.5 | signal |
| 7 | Febrile Neutropenia | 367 | 18.4 | 19.5 | signal |
| 8 | Bone Marrow Failure | 102 | 16.6 | 16.8 | signal |
| 9 | Impaired Quality Of Life | 68 | 15.7 | 15.9 | signal |
| 10 | Agranulocytosis | 84 | 15.1 | 15.3 | signal |
| 11 | White Blood Cell Count Decreased | 482 | 14.8 | 15.9 | signal |
| 12 | Breast Cancer Metastatic | 44 | 13.6 | 13.7 | signal |
| 13 | Neoplasm Progression | 140 | 13.3 | 13.5 | signal |
| 14 | Ejection Fraction Decreased | 56 | 11.9 | 12.0 | signal |
| 15 | Liver Injury | 84 | 11.5 | 11.7 | signal |
| 16 | Metastases To Bone | 51 | 10.4 | 10.4 | signal |
| 17 | Pneumocystis Jirovecii Pneumonia | 30 | 10.0 | 10.0 | signal |
| 18 | Drug-induced Liver Injury | 91 | 9.8 | 9.9 | signal |
| 19 | Metastases To Liver | 51 | 9.7 | 9.7 | signal |
| 20 | Palmar-plantar Erythrodysaesthesia Syndrome | 66 | 9.4 | 9.5 | signal |
| 21 | Cardiomyopathy | 41 | 9.2 | 9.3 | signal |
| 22 | Metastases To Lung | 31 | 8.9 | 9.0 | signal |
| 23 | Acute Myeloid Leukaemia | 41 | 8.7 | 8.8 | signal |
| 24 | Lymphocyte Count Decreased | 42 | 7.9 | 7.9 | signal |
| 25 | Alopecia | 458 | 7.7 | 8.2 | signal |
| 26 | Leukopenia | 115 | 7.6 | 7.8 | signal |
| 27 | Transaminases Increased | 47 | 7.0 | 7.1 | signal |
| 28 | Interstitial Lung Disease | 102 | 7.0 | 7.1 | signal |
| 29 | Neutropenia | 274 | 6.7 | 7.0 | signal |
| 30 | Polyneuropathy | 23 | 6.4 | 6.4 | signal |
| 31 | Mucosal Inflammation | 45 | 5.7 | 5.8 | signal |
| 32 | Hepatic Failure | 52 | 5.7 | 5.7 | signal |
| 33 | Temperature Intolerance | 17 | 5.5 | 5.5 | signal |
| 34 | Neutrophil Count Increased | 17 | 5.5 | 5.5 | signal |
| 35 | Adrenal Insufficiency | 18 | 5.0 | 5.0 | signal |
| 36 | Platelet Count Decreased | 158 | 4.9 | 5.0 | signal |
| 37 | Cytopenia | 17 | 4.7 | 4.7 | signal |
| 38 | Pancytopenia | 79 | 4.7 | 4.7 | signal |
| 39 | Myocarditis | 16 | 4.7 | 4.7 | signal |
| 40 | Hepatocellular Injury | 20 | 4.7 | 4.7 | signal |
| 41 | Blood Lactate Dehydrogenase Increased | 22 | 4.6 | 4.6 | signal |
| 42 | Cardiac Failure | 110 | 4.5 | 4.6 | signal |
| 43 | Gamma-glutamyltransferase Increased | 30 | 4.5 | 4.5 | signal |
| 44 | Mitral Valve Incompetence | 15 | 4.4 | 4.4 | signal |
| 45 | C-reactive Protein Increased | 47 | 4.3 | 4.3 | signal |
| 46 | Aspartate Aminotransferase Increased | 65 | 4.1 | 4.1 | signal |
| 47 | Haematotoxicity | 11 | 3.9 | 3.9 | signal |
| 48 | Hypophagia | 30 | 3.9 | 3.9 | signal |
| 49 | Device Use Issue | 20 | 3.8 | 3.8 | signal |
| 50 | Hepatic Cytolysis | 14 | 3.8 | 3.8 | signal |
| 51 | Gastrointestinal Disorder | 97 | 3.6 | 3.7 | signal |
| 52 | Alanine Aminotransferase Increased | 67 | 3.6 | 3.6 | signal |
| 53 | Cerebral Infarction | 26 | 3.5 | 3.5 | signal |
| 54 | Hypocalcaemia | 20 | 3.5 | 3.5 | signal |
| 55 | Supraventricular Tachycardia | 10 | 3.5 | 3.5 | signal |
| 56 | Neurotoxicity | 18 | 3.4 | 3.4 | signal |
| 57 | Hypokalaemia | 47 | 3.4 | 3.4 | signal |
| 58 | Septic Shock | 44 | 3.4 | 3.4 | signal |
| 59 | Feeding Disorder | 20 | 3.3 | 3.3 | signal |
| 60 | Malignant Neoplasm Progression | 102 | 3.3 | 3.4 | signal |
| 61 | Neuropathy Peripheral | 94 | 3.3 | 3.3 | signal |
| 62 | Thrombocytopenia | 109 | 3.2 | 3.3 | signal |
| 63 | Pneumonitis | 26 | 3.2 | 3.2 | signal |
| 64 | Skin Fissures | 18 | 3.2 | 3.2 | signal |
| 65 | Pyrexia | 329 | 3.1 | 3.3 | signal |
| 66 | Splenomegaly | 11 | 3.1 | 3.1 | signal |
| 67 | Vomiting | 411 | 2.9 | 3.0 | signal |
| 68 | Electrolyte Imbalance | 10 | 2.9 | 2.9 | signal |
| 69 | Sensory Disturbance | 14 | 2.9 | 2.9 | signal |
| 70 | Hepatic Encephalopathy | 8 | 2.8 | 2.8 | signal |
| 71 | Emotional Distress | 104 | 2.8 | 2.9 | signal |
| 72 | Mouth Ulceration | 18 | 2.8 | 2.8 | signal |
| 73 | Cold Sweat | 15 | 2.8 | 2.8 | signal |
| 74 | Asthenia | 319 | 2.8 | 2.9 | signal |
| 75 | Sinus Tachycardia | 12 | 2.8 | 2.8 | signal |
| 76 | Anaemia | 161 | 2.8 | 2.8 | signal |
| 77 | Cardiac Failure Congestive | 67 | 2.7 | 2.8 | signal |
| 78 | White Blood Cell Count Increased | 31 | 2.7 | 2.7 | signal |
| 79 | Osteonecrosis Of Jaw | 20 | 2.7 | 2.7 | signal |
| 80 | Hyponatraemia | 45 | 2.7 | 2.7 | signal |
| 81 | Drug Eruption | 14 | 2.6 | 2.6 | signal |
| 82 | Decreased Appetite | 183 | 2.6 | 2.7 | signal |
| 83 | Hypothyroidism | 25 | 2.6 | 2.6 | signal |
| 84 | Drug Exposure During Pregnancy | 27 | 2.6 | 2.6 | signal |
| 85 | Vasculitis | 9 | 2.6 | 2.6 | signal |
| 86 | Ventricular Extrasystoles | 8 | 2.5 | 2.5 | signal |
| 87 | Oral Candidiasis | 10 | 2.5 | 2.5 | signal |
| 88 | Paraesthesia Oral | 11 | 2.5 | 2.5 | signal |
| 89 | Bacteraemia | 9 | 2.5 | 2.5 | signal |
| 90 | Premature Baby | 23 | 2.5 | 2.5 | signal |
| 91 | Heart Rate Irregular | 17 | 2.5 | 2.5 | signal |
| 92 | Dysphagia | 70 | 2.4 | 2.5 | signal |
| 93 | Haemoglobin Decreased | 75 | 2.4 | 2.4 | signal |
| 94 | Pleural Effusion | 44 | 2.4 | 2.4 | signal |
| 95 | Leukocytosis | 13 | 2.4 | 2.4 | signal |
| 96 | Hyperglycaemia | 26 | 2.4 | 2.4 | signal |
| 97 | Lymphopenia | 10 | 2.4 | 2.4 | signal |
| 98 | Disseminated Intravascular Coagulation | 10 | 2.3 | 2.3 | signal |
| 99 | Metastases To Central Nervous System | 9 | 2.3 | 2.3 | signal |
| 100 | Haematocrit Decreased | 14 | 2.3 | 2.3 | signal |
| 101 | Red Blood Cell Count Decreased | 20 | 2.3 | 2.3 | signal |
| 102 | Electrocardiogram Qt Prolonged | 25 | 2.3 | 2.3 | signal |
| 103 | Injection Site Induration | 9 | 2.3 | 2.3 | signal |
| 104 | Discomfort | 42 | 2.3 | 2.3 | signal |
| 105 | Stomatitis | 42 | 2.3 | 2.3 | signal |
| 106 | Hyperthyroidism | 10 | 2.3 | 2.3 | signal |
| 107 | Myelodysplastic Syndrome | 10 | 2.3 | 2.3 | signal |
| 108 | Blood Alkaline Phosphatase Increased | 17 | 2.3 | 2.3 | signal |
| 109 | Nausea | 538 | 2.3 | 2.4 | signal |
| 110 | Caesarean Section | 8 | 2.3 | 2.3 | signal |
| 111 | Ischaemic Stroke | 12 | 2.2 | 2.2 | signal |
| 112 | Disease Progression | 78 | 2.2 | 2.2 | signal |
| 113 | Presyncope | 16 | 2.2 | 2.2 | signal |
| 114 | Blood Urea Increased | 11 | 2.2 | 2.2 | signal |
| 115 | Hepatic Steatosis | 12 | 2.1 | 2.1 | signal |
| 116 | Cardiogenic Shock | 9 | 2.1 | 2.1 | signal |
| 117 | Blood Bilirubin Increased | 17 | 2.1 | 2.1 | signal |
| 118 | Skin Infection | 7 | 2.1 | 2.1 | no signal |
| 119 | Acute Respiratory Distress Syndrome | 11 | 2.1 | 2.1 | signal |
| 120 | Gastroenteritis | 9 | 2.0 | 2.0 | no signal |
| 121 | Dehydration | 82 | 2.0 | 2.0 | signal |
| 122 | Pericardial Effusion | 14 | 2.0 | 2.0 | signal |
| 123 | Pulmonary Mass | 9 | 2.0 | 2.0 | no signal |
| 124 | Conjunctivitis | 11 | 2.0 | 2.0 | no signal |
| 125 | Chest Discomfort | 61 | 2.0 | 2.0 | no signal |
| 126 | Hyperbilirubinaemia | 6 | 1.9 | 1.9 | no signal |
| 127 | Tooth Disorder | 13 | 1.9 | 1.9 | no signal |
| 128 | Petechiae | 6 | 1.9 | 1.9 | no signal |
| 129 | Breast Cancer | 54 | 1.9 | 1.9 | no signal |
| 130 | Rhinorrhoea | 37 | 1.9 | 1.9 | no signal |
| 131 | Pulmonary Hypertension | 12 | 1.9 | 1.9 | no signal |
| 132 | Pulmonary Embolism | 54 | 1.9 | 1.9 | no signal |
| 133 | Pain In Jaw | 16 | 1.9 | 1.9 | no signal |
| 134 | Sudden Death | 6 | 1.9 | 1.9 | no signal |
| 135 | Pallor | 15 | 1.8 | 1.8 | no signal |
| 136 | Erythema Multiforme | 5 | 1.8 | 1.8 | no signal |
| 137 | Face Oedema | 9 | 1.8 | 1.8 | no signal |
| 138 | Squamous Cell Carcinoma | 5 | 1.8 | 1.8 | no signal |
| 139 | Abortion Induced | 5 | 1.8 | 1.8 | no signal |
| 140 | Eye Haemorrhage | 7 | 1.7 | 1.7 | no signal |
| 141 | Pulmonary Fibrosis | 10 | 1.7 | 1.7 | no signal |
| 142 | Myocardial Ischaemia | 6 | 1.7 | 1.7 | no signal |
| 143 | Sinus Bradycardia | 5 | 1.7 | 1.7 | no signal |
| 144 | Haematemesis | 13 | 1.7 | 1.7 | no signal |
| 145 | Osteomyelitis | 9 | 1.6 | 1.6 | no signal |
| 146 | Full Blood Count Decreased | 10 | 1.6 | 1.6 | no signal |
| 147 | Haematuria | 17 | 1.6 | 1.6 | no signal |
| 148 | Thyroid Cancer | 6 | 1.6 | 1.6 | no signal |
| 149 | Emphysema | 5 | 1.6 | 1.6 | no signal |
| 150 | Tooth Abscess | 5 | 1.6 | 1.6 | no signal |
| 151 | Hypercalcaemia | 6 | 1.6 | 1.6 | no signal |
| 152 | Folliculitis | 5 | 1.6 | 1.6 | no signal |
| 153 | Breast Cancer Female | 13 | 1.6 | 1.6 | no signal |
| 154 | Gastric Cancer | 12 | 1.6 | 1.6 | no signal |
| 155 | Depressed Level Of Consciousness | 18 | 1.5 | 1.5 | no signal |
| 156 | Mental Impairment | 11 | 1.5 | 1.5 | no signal |
| 157 | Palpitations | 53 | 1.5 | 1.5 | no signal |
| 158 | Paraesthesia | 70 | 1.5 | 1.5 | no signal |
| 159 | Appendicitis | 4 | 1.4 | 1.4 | no signal |
| 160 | Altered State Of Consciousness | 9 | 1.4 | 1.4 | no signal |
| 161 | Circulatory Collapse | 7 | 1.4 | 1.4 | no signal |
| 162 | Dermatitis Allergic | 5 | 1.3 | 1.3 | no signal |
| 163 | Injection Site Extravasation | 5 | 1.3 | 1.3 | no signal |
| 164 | Hypotonia | 4 | 1.3 | 1.3 | no signal |
| 165 | Therapy Partial Responder | 6 | 1.3 | 1.3 | no signal |
| 166 | Toxic Skin Eruption | 4 | 1.3 | 1.3 | no signal |
| 167 | Inappropriate Antidiuretic Hormone Secretion | 4 | 1.3 | 1.3 | no signal |
| 168 | Thyroid Disorder | 6 | 1.3 | 1.3 | no signal |
| 169 | Peritonitis | 8 | 1.3 | 1.3 | no signal |
| 170 | Hot Flush | 29 | 1.3 | 1.3 | no signal |
| 171 | Breast Pain | 4 | 1.2 | 1.2 | no signal |
| 172 | Amenorrhoea | 6 | 1.2 | 1.2 | no signal |
| 173 | Hypertensive Crisis | 4 | 1.2 | 1.2 | no signal |
| 174 | Intestinal Perforation | 4 | 1.2 | 1.2 | no signal |
| 175 | Pulmonary Arterial Hypertension | 5 | 1.1 | 1.1 | no signal |
| 176 | Maternal Exposure During Pregnancy | 29 | 1.1 | 1.1 | no signal |
| 177 | Diarrhoea Haemorrhagic | 3 | 1.1 | 1.1 | no signal |
| 178 | Grand Mal Convulsion | 3 | 1.1 | 1.1 | no signal |
| 179 | Posterior Reversible Encephalopathy Syndrome | 3 | 1.0 | 1.0 | no signal |
| 180 | Anaphylactic Shock | 8 | 1.0 | 1.0 | no signal |
| 181 | Anorexia | 4 | 1.0 | 1.0 | no signal |
| 182 | Skin Exfoliation | 25 | 1.0 | 1.0 | no signal |
| 183 | Neoplasm Malignant | 19 | 0.9 | 0.9 | no signal |
| 184 | Bipolar Disorder | 3 | 0.9 | 0.9 | no signal |
| 185 | Premature Delivery | 4 | 0.8 | 0.8 | no signal |
| 186 | Vaginal Haemorrhage | 10 | 0.8 | 0.8 | no signal |
| 187 | Uveitis | 3 | 0.7 | 0.7 | no signal |
| 188 | Osteonecrosis | 7 | 0.7 | 0.7 | no signal |
| 189 | Cytokine Release Syndrome | 4 | 0.7 | 0.7 | no signal |
| 190 | Menorrhagia | 3 | 0.5 | 0.5 | no signal |
| 191 | Injection Site Erythema | 16 | 0.4 | 0.4 | no signal |
| 192 | Hepatic Cancer | 3 | 0.4 | 0.4 | no signal |