Trajenta®: An established safety and tolerability profile, with an adverse events rate similar to placebo1.
Pancreatitis is an important but infrequent adverse drug reaction associated with linagliptin use.
The adverse drug reactions for linagliptin as described in the EU SmPC are provided in the table below.
- * Based on post-marketing experience
- **Based on lipase elevations >3xULN observed in clinical trials
- *Based on Linagliptin cardiovascular and renal safety study (CARMELINA®). Click here to know more about the CARMELINA® study.
Very common: ≥ 1/10, common: ≥ 1/100 to <1/10, uncommon: ≥ 1/1,000 to < 1/100, rare: ≥ 1/10,000 to < 1/1,000, very rare: <1/10,000 or not known: cannot be estimated from the available data
Use of DPP4 inhibitors has been associated with a risk of developing acute pancreatitis. Acute pancreatitis has been observed in patients taking linagliptin. In a cardiovascular and renal safety study (CARMELINA®) with median observation period of 2.2 years, adjudicated acute pancreatitis was reported in 0.3% of patients treated with linagliptin and in 0.1% of patients treated with placebo. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, TRAJENTA® should be discontinued; if acute pancreatitis is confirmed, TRAJENTA® should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Bullous pemphigoid has been observed in patients taking linagliptin. In the CARMELINA® study, bullous pemphigoid was reported in 0.2% of patients on treatment with linagliptin and in no patient on placebo. If bullous pemphigoid is suspected, TRAJENTA® should be discontinued.
Click here for comprehensive safety information in the Summary of Product Characteristics.
Click here for information about special warnings and precautions for use.