Table 4 – Adverse reactions reported through post-marketing experience

The following adverse reactions have been identified during post-approval use of SUTENT. 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.

Infections and infestations a
 
Uncommon*
 Infections (with or without neutropoenia)
 
Blood and lymphatic system disorderb
 
Uncommon*
 Thrombotic microangiopathy
 
Immune system disordersc
 
Uncommon*
 Angioedema, hypersensitivity reaction
 
Endocrine disordersed
 
Uncommon*
 Hyperthyroidism
 
Cardiac disorders:
 
Uncommon:
 Cardiac failure, cardiac failure congestive, left ventricular failure
 
Rare:
 Prolonged QT interval, Torsade de pointes
 
Uncommon*
 Cardiomyopathy, Pericardial effusion
 
Respiratory, thoracic and mediastinal disorders
 
Uncommon*
 Haemoptysis
 
Gastrointestinal disorders:
 
Uncommon:
 Pancreatitis
 
Rare:
 Gastrointestinal perforation
 
Hepatobiliary disorderse:
 
Uncommon:
 Hepatic failure
 
Uncommon*
 Hepatitis
 
Muscoloskeletal and connective tissue disordersf
 
Uncommon*
 Myopathy and/or rhabdomyolysis
 
Uncommon*
 Fistula formation
 
Uncommon*
 Impaired wound healing
 
Uncommon*
 Osteonecrosis of the jaw
 
Renal and urinary disordersg
 
Uncommon*
 Renal failure, Renal failure acute, Proteinuria, Nephrotic syndrome
 
Pulmonary disordersh
  
Uncommon*
 Pleural effusion
 
Uncommon*
 Pulmonary embolism and respiratory failure
 
Investigations:
 
Common:
 Elevated thyroid stimulating hormone (TSH)
 

* Frequency of the adverse reaction calculated with the 3/X methodology described in the Guideline on Summary o