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: Common: Sepsis.
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: Uncommon: Anaphylactoidb reactions.
Endocrine disorders: Not known: Blood amylase increased, inappropriate antidiuretic hormone secretion.
Metabolism and nutrition disorders: Very common: Hyponatraemia.
Uncommon: Hypomagnesaemia.
Rare: Hypercholesterolaemia.
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.
Eye disorders: Not known: Vision blurred, colour blindness acquired, blindness cortical, optic neuritis, papilloedema, retinal pigmentation.
Ear and labyrinth disorders: Uncommon: Ototoxicity.
Not known: Tinnitus, deafness.
Cardiac disorders: Common: Arrhythmia, bradycardia, tachycardia.
Rare: Myocardial infarction.
Very rare: Cardiac arrest.
Not known: Cardiac disorder.
Vascular disorders: Not known: Thrombotic microangiopathy (haemolytic uraemic syndrome), Raynaud's phenomenon.
Gastrointestinal disorders: Rare: Stomatitis.
Not known: Vomiting, nausea, anorexia, hiccups, diarrhoea.
Hepatobiliary disorders: 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.
a Infectious complications have led to death in some patients.
b 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.
c Elevations in BUN and creatinine, serum uric acid, and/or decrease in creatinine clearance are subsumed under renal insufficiency/failure.
d Local soft tissue toxicity including cellulitis, fibrosis, and necrosis (common), pain (common), oedema (common) and erythema (common) as the result of extravasation.
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