Common
 Uncommon
 Rare
 Very rare
 
Immune system disorders
 
 
 
 
 Anaphylactic reaction 2

 
Metabolism and nutrition disorder
 
 
 
 Dehydration, generally associated with nausea, vomiting and/or diarrhoea. 2
 
 
Nervous system disorders
 
 
 Dysgeusia 2
 
 
 
Gastrointestinal disorders
 
 
 Acute pancreatitis (see section 4.4). 1,3
 
 
 
Skin and subcutaneous tissue disorders
 
Hyperhidrosis 1
 
 Macular or papular rash 2
 
 
 
 
 Pruritus, and/ or urticaria 2
 
 
 
 
 Angioneurotic oedema 2
 
 
 
 
 Alopecia 2
 
 
Renal and urinary disorders
 
 
 
 Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine 2

(see section 4.4).

 
 
General disorders and administration site conditions
 
Asthenia 1
 
 
 
 
Feeling jittery 1
 
 
 
 
Investigations
 
 
 
 International normalised ratio increased with concomitant warfarin use, some reports associated with bleeding

(see section 4.4). 2

1 Rate based on exenatide twice daily clinical trial data.

2 Rate based on exenatide twice daily spontaneous data.

3 Events were uncommon in all treatment groups.

Description of selected adverse reactions

Hypoglycaemia

The incidence of hypoglycaemia was increased when BYDUREON was used in combination with a sulphonylurea (15.9 % versus 2.2 %) (see section 4.4). To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea may be considered (see sections 4.2 and 4.4).

BYDUREON was associated with a significantly lower incidence of episodes of hypoglycaemia than insulin glargine in patients also receiving metformin therapy (3 % versus 19 %) and in patients also receiving metformin plus sulphonylurea therapy (20 % versus 42 %).

Across all studies most episodes (96.8 % n=32) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate. One patient was reported with major hypoglycaemia since he had a low blood glucose value (2.2 mmol/l) and requested assistance with oral carbohydrate treatment which resolved the event.

Nausea

The most frequently reported adverse reaction was nausea. In patients treated with BYDUREON, generally 20 % reported at least one episode of nausea compared to 34 % of exenatide twice daily patients. Most episodes of nausea were mild to moderate. With continued therapy, the frequency decreased in most patients who initially experienced nausea.

The incidence of withdrawal due to adverse events during the 30-week controlled trial was 6 % for BYDUREONtreated patients, 5 % for exenatide twice daily-treated patients. The most common adverse events leading to withdrawal in either treatment group were nausea and vomiting