Uncommon:
Gynaecomastia, erectile dysfunction, menorrhagia, menstruation irregular, sexual dysfunction, nipple pain, breast enlargement, scrotal oedema
Rare:
Haemorrhagic corpus luteum/haemorrhagic ovarian cyst
General disorders and administration site conditions
Very common:
Fluid retention and oedema, fatigue
Common:
Weakness, pyrexia, anasarca, chills, rigors
Uncommon:
Chest pain, malaise
Investigations
Very common:
Weight increased
Common:
Weight decreased
Uncommon:
Blood creatinine increased, blood creatine phosphokinase increased, blood lactate dehydrogenase increased, blood alkaline phosphatase increased
Rare:
Blood amylase increased
1 Pneumonia was reported most commonly in patients with transformed CML and in patients with GIST.
2 Headache was the most common in GIST patients.
3 On a patient-year basis, cardiac events including congestive heart failure were more commonly observed in patients with transformed CML than in patients with chronic CML.
4 Flushing was most common in GIST patients and bleeding (haematoma, haemorrhage) was most common in patients with GIST and with transformed CML (CML-AP and CML-BC).
5 Pleural effusion was reported more commonly in patients with GIST and in patients with transformed CML (CML-AP and CML-BC) than in patients with chronic CML.
6+7 Abdominal pain and gastrointestinal haemorrhage were most commonly observed in GIST patients.
8 Some fatal cases of hepatic failure and of hepatic necrosis have been reported.
9 Musculoskeletal pain and related events were more commonly observed in patients with CML than in GIST patients.
The following types of reactions have been reported mainly from post-marketing experience with Glivec. This includes spontaneous case reports as well as serious adverse events from ongoing studies, the expanded access programmes, clinical pharmacology studies and exploratory studies in unapproved indications. Because these reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to imatinib exposure.
Table 2 Adverse reactions from post-marketing reports
Neoplasm benign, malignant and unspecified (including cysts and polyps)
Not known:
Tumour haemorrhage/tumour necrosis
Immune system disorders
Not known:
Anaphylactic shock
Nervous system disorders
Not known:
Cerebral oedema
Eye disorders
Not known:
Vitreous haemorrhage
Cardiac disorders
Not known:
Pericarditis, cardiac tamponade
Vascular disorders
Not known:
Thrombosis/embolism
Respiratory, thoracic and mediastinal disorders
Not known:
Acute respiratory failure1, interstitial lung disease
Gastrointestinal disorders
Not known:
Ileus/intestinal obstruction, gastrointestinal perforation, diverticulitis
Skin and subcutaneous tissue disorders
Not known:
Palmoplantar erythrodysesthes
