Summary of the safety profile: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leucopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis. Other undesirable effects include renal toxicities, increased aminotransferases, alopecia, fatigue, dehydration, rash, infection/sepsis and neuropathy. Rarely seen events include Stevens-Johnson syndrome and Toxic epidermal necrolysis. (See Table 4.)
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Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident, and transient ischaemic attack, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent. Most of the patients in whom these events have been observed had pre-existing cardiovascular risk factors.
Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Uncommon cases of oedema have been reported in patients treated with pemetrexed.
Oesophagitis/ radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Sepsis, sometimes fatal, has been commonly reported during clinical trials with pemetrexed.
Nephrogenic diabetes insipidus and renal tubular necrosis have been reported in post marketing setting with an unknown frequency