The following undesirable effects have been observed and reported during treatment with epirubicin hydrochloride with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
More than 10% of treated patients can expect to develop undesirable effects. The most common undesirable effects are myelosuppression, gastrointestinal side effects, anorexia, alopecia, infection.
Infections and infestations:
Not known: Septic shock, sepsis, pneumonia.
Neoplasms benign, malignant and unspecified (incl. cysts and polyps):
Rare: Acute lymphocytic leukaemia, acute myelogenous leukaemia.
Blood and the lymphatic system disorders:
Very common: Myelosuppression (leukopenia, granulocytopenia and neutropenia, anaemia and febrile neutropenia).
Not known: Haemorrhage and tissue hypoxia as result of myelosuppression.
Immune system disorders:
Metabolism and nutrition disorders:
Common: Anorexia, dehydration.
Rare: Hyperuricaemia (see Precautions).
Nervous system disorders:
Not known: Conjunctivitis, keratitis.
Rare: Congestive heart failure (dyspnoea, oedema, hepatomegaly, ascites, pulmonary oedema, pleural effusions, gallop rhythm), cardiotoxicity (e.g. ECG abnormalities, arrhythmias, cardiomyopathy), ventricular tachycardia, bradycardia, AV block, bundle-branch block.
Common: Hot flushes.
Uncommon: Phlebitis, thrombophlebitis.
Not known: Shock, thromboembolism, including pulmonary emboli.
Common: Mucositis, oesophagitis, stomatitis, vomiting, diarrhoea, nausea.
Not known: Oral mucosa erosion, mouth ulceration, oral pain, mucosal burning sensation, mouth haemorrhage, and buccal pigmentation.
Skin and subcutaneous tissue disorders:
Very common: Alopecia.
Not known: Local toxicity, rash, itch, skin changes, erythema, flushes, skin and nail hyperpigmentation, photosensitivity, hypersensitivity to irradiated skin (radiation-recall reaction).
Renal and urinary disorders:
Very common: Red colouration of urine for 1 to 2 days after administration.
Reproductive system and breast disorders:
Rare: Amenorrhoea, azoospermia.
General disorders and administration site conditions:
Common: Infusion site erythema.
Rare: Malaise, asthenia, fever, chills.
Not known: Phlebosclerosis, local pain, severe cellulitis, tissue necrosis after accidental paravenous injection.
Rare: Changes in transaminase levels.
Not known: Asymptomatic drops in left ventricular ejection fraction.
Injury, poisoning and procedural complications:
Common: Chemical cystitis, sometimes haemorrhagic, has been observed following intravesical administration (see Precautions).
lntravesical administration: As only a small amount of active ingredient is reabsorbed after intravesical instillation, severe systemic adverse drug reactions as well as allergic reactions are rare. Commonly reported are local reactions like burning sensation and frequent voiding (pollakisuria). Occasional bacterial or chemical cystitis have been reported (see Precautions). These ADRs are mostly reversible.