The most frequently reported adverse events (>10%) of cisplatin were hematological (leukopenia, thrombocytopenia and anemia), gastrointestinal (anorexia, nausea, vomiting and diarrhea), ear disorders (hearing impairment), renal disorders (renal failure, nephrotoxicity, hyperuricemia) and fever.
Serious toxic effects on the kidneys, bone marrow and ears have been reported in up to about one third of patients given a single dose of cisplatin; the effects are generally dose-related and cumulative. Ototoxicity may be more severe in children.
Frequencies are defined using the following convention: 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.
Adverse Drug Events reported during clinical or post-marketing experience (MedDRA terms): Infections and infestations:
Not known: Infectiona
Blood and lymphatic system disorders:
Very common: Bone marrow failure, thrombocytopenia, leukopenia, anaemia.
Not known: Coombs positive haemolytic anaemia.
Neoplasm benign, malignant, and unspecified:
Rare: Acute leukaemia.
Immune system disorders:
Not known: Blood amylase increased, inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders:
Very common: Hyponatraemia.
Very rare: Increased blood iron.
Not known: Dehydration, hypokalaemia, hypophosphataemia, hyperuricaemia, hypocalcaemia, tetany.
Nervous system disorders:
Rare: Convulsion, neuropathy peripheral, leukoencephalopathy, reversible posterior leukoencephalopathy syndrome.
Not known: Cerebrovascular accident, haemorrhagic stroke, ischaemic stroke, ageusia, cerebral arteritis, Lhermitte's sign, myelopathy, autonomic neuropathy.
Not known: Vision blurred, colour blindness acquired, blindness cortical, optic neuritis, papilloedema, retinal pigmentation.
Ear and labyrinth disorders:
Not known: Tinnitus, deafness.
Common: Arrhythmia, bradycardia, tachycardia.
Rare: Myocardial infarction.
Very rare: Cardiac arrest.
Not known: Cardiac disorder.
Not known: Thrombotic microangiopathy (haemolytic uraemic syndrome), Raynaud's phenomenon.
Not known: Vomiting, nausea, anorexia, hiccups, diarrhoea.
Not known: Hepatic enzymes increased, blood bilirubin increased.
Respiratory, thoracic and mediastinal disorders:
Not known: Pulmonary embolism.
Skin and subcutaneous tissue disorders:
Not known: Rash, alopecia.
Musculoskeletal, connective tissue and bone disorders:
Not known: Muscle spasms.
Renal and urinary disorders:
Not known: Renal failure acute, renal failure; renal tubular disorder.
Reproductive system and breast disorders:
Uncommon: Abnormal spermatogenesis.
General disorders and administration site conditions:
Very common: Pyrexia.
Not known: Asthenia, malaise, injection site extravasationd
Infectious complications have led to death in some patients.
Symptoms reported for anaphylactoid reaction such as facial oedema (PT-face oedema), wheezing, bronchospasm, tachycardia, and hypotension will be included in the parentheses for anaphylactoid reaction in the AE frequency table.
Elevations in BUN and creatinine, serum uric acid, and/or decrease in creatinine clearance are subsumed under renal insufficiency/failure.
Local soft tissue toxicity including cellulitis, fibrosis, and necrosis (common), pain (common), oedema (common) and erythema (common) as the result of extravasation.