nd infestations
fungal skin infection
Uncommon†
Immune system disorders
hypersensitivity reactions including anaphylactic responses (see section 4.4) ‡
Frequency not known
Metabolism and nutrition disorders
hypoglycaemia*
Very common
Common
Very common
Nervous system disorders
headache
Common
Uncommon
somnolence
Uncommon
Respiratory, thoracic and mediastinal disorders
cough
Common†
Gastrointestinal disorders
diarrhoea
Uncommon
Common
nausea
Common
constipation
Common
upper abdominal pain
Uncommon
vomiting
Frequency not known ‡
Frequency not known ‡
Common
Frequency not known ‡
dry mouth
Uncommon
acute pancreatitis (see section 4.4) ‡
Frequency not known
fatal and non-fatal haemorrhagic and necrotizing pancreatitis‡
Frequency not known
Skin and subcutaneous tissue disorders
angioedema‡
Frequency not known
rash‡
Frequency not known
urticaria‡
Frequency not known
cutaneous vasculitis‡
Frequency not known
exfoliative skin conditions‡ including Stevens-Johnson syndrome
Frequency not known
Musculoskeletal and connective tissue disorders
arthralgia‡
Frequency not known
myalgia‡
Frequency not known
Renal and urinary disorders
impaired renal function‡
Frequency not known
acute renal failure‡
Frequency not known
General disorders and administration site conditions
peripheral oedema
Common†
Investigations
blood glucose decreased
Uncommon
* In clinical trials of sitagliptin as monotherapy and sitagliptin as part of combination therapy with metformin or metformin and a PPARγ agent, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
† 54-week time point.
‡Adverse reactions were ide