bsp;Not known
Infections and infestations
infection
folliculitis
Blood and lymphatic system disorders
lymphopenia
leucopenia
neutropenia
anaemia
thrombocytopenia
Immune system disorders
hypersensitivity reactions (including skin reactions and urticaria)
anaphylactic reaction
angioedema
Endocrine disorders
hypothyroidism
hyperthyroidism
Metabolism and nutrition disorders
anorexia
hypo-phosphataemia
hypocalcaemia
hypokalaemia
hyponatraemia
dehydration
Psychiatric disorders
depression
Nervous system disorders
peripheral sensory neuropathy
dysgeusia
reversible posterior leukoencephalo-pathy*
encephalopathy°
Ear and labyrinth disorders
tinnitus
Cardiac disorders
congestive heart failure*
myocardial ischaemia and infarction*
QT prolongation
Vascular disorders
haemorrhage (inc. gastrointestinal*, respiratory tract* and cerebral haemorrhage*)
hypertension
flushing
hypertensive crisis*
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
dysphonia
interstitial lung disease-like events* (pneumonitis, radiation pneumonitis, acute respiratory distress, etc. )
Gastrointestinal disorders
diarrhoea
nausea
vomiting
constipation
stomatitis (including dry mouth and glossodynia)
dyspepsia
dysphagia
gastro oesophageal reflux disease
pancreatitis
gastritis
gastrointestinal perforations*
Hepatobiliary disorders
increase in bilirubin and jaundice, cholecystitis, cholangitis
drug induced hepatitis*
Skin and subcutaneous tissue disorders
dry skin
rash
alopecia
hand foot skin reaction**
erythema
pruritus
keratoacanthoma/ squamous cell cancer of the skin
dermatitis exfoliative
acne
skin desquamation
hyperkeratosis
eczema
erythema multiforme
radiation recall dermatitis
Stevens-Johnson syndrome
leucocytoclastic vasculitis
toxic epidermal necrolysis*
Musculo-skeletal and connective tissue disorders
arthralgia
myalgia
muscle spasms
rhabdomyolysis
Renal and urinary disorders
renal failure
proteinuria
nephrotic syndrome
Reproductive system and breast disorders
erectile dysfunction
gynaecomastia
General disorders and administration site conditions
fatigue
pain (including mouth, abdominal, bone, tumour pain and headache
fever
asthenia
influenza like illness
mucosal inflammation
Investigations
weight decreased
increased amylase
increased lipase
transient increase in transaminases
transient increase in blood alkaline phosphatase
INR abnormal, prothrombin level abnormal
* The adverse reactions may have a life-threatening or fatal outcome. Such events are either uncommon or less frequent than uncommon.
** Hand foot skin reaction corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA.
° Cases have been reported in the post marketing setting.
Further information on selected adverse drug reactions
Congestive heart failure
In company sponsored clinica
