Safety and tolerability: Possible side effects
Safety findings from the five double-blind, placebo-controlled trials (5,813 overweight or obese adult patients with at least one weight-related comorbidity).1
Safety findings from the five double-blind, placebo-controlled trials (5,813 overweight or obese adult patients with at least one weight-related comorbidity).1
Liraglutide was evaluated for safety in 5 double-blind, placebo-controlled trials that enrolled 5,813 overweight or obese adults with at least one weight-related comorbidity. Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%) (see tabulated list of adverse reactions reported in adults is shown below).1
Adverse reactions reported in adults from placebo-controlled trials1
| MedDRA system organ class | Very common | Common | Uncommon | Rare |
| Immune system disorders | Anaphylactic reaction | |||
| Metabolism and nutrition disorders | Hypoglycaemia* | Dehydration | ||
| Psychiatric disorders | Insomnia** | |||
| Nervous system disorders | Headache | Dizziness
Dysgeusia |
||
| Cardiac disorders | Tachycardia | |||
| Gastrointestinal disorders | Nausea
Diarrhoea Vomiting Constipation |
Dry mouth
Dyspepsia Gastritis Gastroesophageal reflex disease Abdominal pain, upper Flatulence Eructation Abdominal distension |
Pancreatitis***
Delayed gastric emptying**** |
|
| Hepatobiliary disorders | Cholelithiasis*** | Cholecystitis*** | ||
| Skin and subcutaneous tissue disorders | Rash | Urticaria | ||
| Renal and urinary disorders | Acute renal failure,
renal impairment |
|||
| General disorders and administration site conditions | Injection site reactions
Asthenia Fatigue |
Malaise | ||
| Investigations | Increased lipase
Increased amylase |
Frequencies defined as:
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); Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
*Hypoglycaemia (based on self-reported symptoms by patients and not confirmed by blood glucose measurements) reported in patients without type 2 diabetes mellitus treated with liraglutide in combination with diet and exercise.
**Insomnia was mainly seen during the first 3 months of treatment.
***See section 4.4. of SmPC
****From controlled phase 2, 3a and 3b clinical trials.
For descriptions of selected adverse reactions, please see SmPC section 4.8
- Nevolat® (liraglutide) Summary of Product Characteristics.
000697593 | December 2024