Gastrointestinal: Nausea, vomiting and diarrhea are the common adverse events following treatment with irinotecan and can be severe. When observed, nausea and vomiting usually occur during or shortly after infusion of irinotecan. In the clinical studies testing the every 3-week-dosage schedule, the median time to the onset of diarrhea was 5 days after irinotecan infusion.
Hematology: Irinotecan commonly causes neutropenia, leukopenia (including lymphocytopenia), and anaemia. Serious thrombocytopenia is uncommon. When evaluated in the trials of weekly administration, the frequency of grade 3 and 4 neutropenia was significantly higher in patients who received previous pelvic/abdominal irradiation than those who had not received such irradiation.
Body as a whole: Asthenia, fever, and abdominal-pain are generally the most common events of this type.
Cholinergic Symptoms: Patients may have cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing and intestinal hyperperistalsis that can cause abdominal cramping and early diarrhea.
Hepatic: In the clinical studies evaluating the weekly dosage schedule, NCI grade 3 or 4 liver enzyme abnormalities were observed in fewer than 10% of patients. These events typically occur in patients with known hepatic metastasis.
Dermatologic: Alopecia has been reported during treatment with irinotecan. Rashes have also been reported but did not result in discontinuation of treatment.
Respiratory: Severe pulmonary events are infrequent. In the clinical studies evaluating the weekly dosage schedule, NCI grade 3 or 4 dyspnea had lung metastasis; the extent to which malignant pulmonary involvement or other pre-existing lung disease may have contributed to dyspnea in these patients is unknown.
Neurologic: Insomnia and dizziness can occur, but are not usually considered to be directly related to the administration of irinotecan. Dizziness may sometimes represent symptomatic evidence of orthostatic hypotension in patients with dehydration.
Cardiovascular: Vasodilation (flushing) may occur during administration of irinotecan. Bradycardia may also occur, but has not required intervention. These effects have been attributed to the cholinergic syndrome sometimes observed during or shortly after infusion of irinotecan.