tory bowel disease
Hepatobiliary disorders
Common:
Increased hepatic enzymes
Uncommon:
Hyperbilirubinaemia, hepatitis, jaundice
Rare
Hepatic failure8, hepatic necrosis
Skin and subcutaneous tissue disorders
Very common:
Periorbital oedema, dermatitis/eczema/rash
Common:
Pruritus, face oedema, dry skin, erythema, alopecia, night sweats, photosensitivity reaction
Uncommon:
Rash pustular, contusion, sweating increased, urticaria, ecchymosis, increased tendency to bruise, hypotrichosis, skin hypopigmentation, dermatitis exfoliative, onychoclasis, folliculitis, petechiae, psoriasis, purpura, skin hyperpigmentation, bullous eruptions
Rare:
Acute febrile neutrophilic dermatosis (Sweet's syndrome), nail discolouration, angioneurotic oedema, rash vesicular, erythema multiforme, leucocytoclastic vasculitis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis (AGEP)
Musculoskeletal and connective tissue disorders
Very common:
Muscle spasm and cramps, musculoskeletal pain including myalgia, arthralgia, bone pain9
Common:
Joint swelling
Uncommon:
Joint and muscle stiffness
Rare:
Muscular weakness, arthritis, rhabdomyolysis/myopathy
Renal and urinary disorders
Uncommon:
Renal pain, haematuria, renal failure acute, urinary frequency increased
Reproductive system and breast disorders
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 ongoi |
