Saxenda side effects: what the Canadian product monograph says

Most common side effects

Gastrointestinal side effects are the most frequently reported side effects of Saxenda. In adult clinical trials, 67.9% of patients on Saxenda reported one, against 39.3% on placebo.

The adult trials in the product monograph count 3384 patients on Saxenda and 1941 patients on placebo. Nausea: 39.3% on Saxenda and 13.8% on placebo. Diarrhea: 20.9% and 9.9%. Constipation: 19.4% and 8.5%. Vomiting: 15.7% and 3.9%.

Headache: 13.6% and 12.6%. Decreased appetite: 10.0% and 2.3%. Dyspepsia: 9.6% and 2.7%. Fatigue: 7.5% and 4.6%. Dizziness: 6.9% and 5.0%.

The percentage of patients who reported nausea declined as treatment continued. Most episodes of gastrointestinal events were mild or moderate and did not lead to discontinuation of therapy.

In the trial of patients aged 12 to less than 18 years, 42.4% on Saxenda reported nausea, 34.4% vomiting and 22.4% diarrhea. Vomiting occurred with a 2-fold higher frequency in these patients than in adults.

The patient part of the product monograph groups the side effects by frequency:

• Very common (may affect more than 1 in 10 people): nausea, vomiting, diarrhea, constipation and headache. These usually go away after a few days or weeks.
• Also very common: lower appetite.
• Common (may affect up to 1 in 10 people): indigestion, inflamed lining of the stomach (gastritis), stomach discomfort, upper stomach pain and heart burn.
• Also common: bloating, wind, belching, dry mouth, feeling weak or tired, changed sense of taste, dizziness, gallstones and injection site reactions.
• Also common: low blood sugar, difficulty sleeping, and an increase of pancreatic enzymes such as lipase and amylase. Difficulty sleeping usually occurs during the first 3 months of treatment.
• Uncommon (may affect up to 1 in 100 people): dehydration, inflamed gallbladder, allergic reactions including skin rash, feeling generally unwell, faster pulse and pancreatitis.
• Rare (may affect up to 1 in 1,000 people): reduced kidney function, acute kidney failure and severe allergic reactions (anaphylaxis).
• Frequency unknown: lumps under the skin (cutaneous amyloidosis), a delay in the emptying of the stomach, and bowel obstruction and ileus.

The serious warnings and precautions box

The product monograph has a Serious Warnings and Precautions box. Its subject is the risk of thyroid C-cell tumours.

Liraglutide causes thyroid C-cell tumours in rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans.

The patient part says that medullary thyroid cancer may lead to death if it is not found early and treated.

While you take Saxenda, tell your doctor if you get a lump or swelling in your neck, hoarseness, trouble swallowing or shortness of breath. These may be symptoms of thyroid cancer.

Other warnings in the product monograph

The product monograph also gives these warnings:

• Pancreatitis: acute pancreatitis, including fatal cases, has been observed in patients treated with liraglutide. If pancreatitis is suspected, Saxenda should promptly be discontinued. If pancreatitis is confirmed, Saxenda should not be restarted.
• Gallbladder: in clinical trials, 2.2% of patients on Saxenda reported gallstones (cholelithiasis), against 0.8% on placebo.
• Heart rate: clinical trials showed mean increases in resting heart rate of 2 to 3 beats per minute. Saxenda should be discontinued for patients with a sustained increase in resting heart rate.
• Low blood sugar: severe hypoglycemia was observed in clinical trials in patients with type 2 diabetes treated with Saxenda. Saxenda and insulin should not be used together.
• Dehydration and kidneys: vomiting and diarrhea can cause dehydration. Dehydration can cause kidney problems that sometimes require hemodialysis.
• Mood: the product monograph says to monitor patients for new or worse depression, suicidal thoughts or behaviour, and unusual changes in mood or behaviour. It says to discontinue Saxenda in patients who experience suicidal thoughts or behaviours.
• Anesthesia: Saxenda delays gastric emptying. Tell your healthcare professional that you take Saxenda before a procedure that requires general anesthesia or sedation.
• Breast cancer: in clinical trials, more cases of breast cancer were observed among patients on Saxenda than among control patients. There were too few cases to determine whether these cases were related to Saxenda.
• Allergic reactions: there are reports of serious hypersensitivity reactions, such as anaphylactic reactions and angioedema, in patients treated with Saxenda.
• Driving: do not drive if you feel dizzy.

Who must not use Saxenda

Each line of the list below starts with the word that the product monograph uses for that group.

• Contraindicated: a personal or family history of medullary thyroid carcinoma.
• Contraindicated: Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Contraindicated: hypersensitivity to liraglutide or to any ingredient in the formulation.
• Contraindicated: pregnancy and breast-feeding.
• Do not use (patient part of the product monograph): pregnant or planning to become pregnant.
• Should not be used: inflammatory bowel disease and diabetic gastroparesis.
• Not recommended: hepatic insufficiency.
• Not recommended: severe renal insufficiency, including end-stage renal disease.
• Not recommended: children under 12 years of age, and adolescents with a body weight below or equal to 60 kg.
• Avoid: a history of suicidal attempts or active suicidal ideation.

When to stop and get medical help

The product monograph says to act in the cases below. You can also report a suspected side effect to Health Canada at 1-866-234-2345.

• Severe allergic reaction (breathing problems, swelling of the throat and face, fast heart beat): stop Saxenda and get immediate medical help.
• Severe pain in the upper abdomen, usually worse on the right side under the ribs: stop Saxenda and contact a doctor immediately.
• Severe stomach pain which does not go away: talk to your doctor straight away. It can be a symptom of pancreatitis.
• A racing or pounding feeling in the chest at rest that lasts several minutes: notify your doctor.
• Lumps under the skin (cutaneous amyloidosis): talk to your healthcare professional.
• Pregnancy: if you are pregnant, stop using Saxenda. Tell your doctor if you become pregnant while you take Saxenda.
• Too much Saxenda: contact a healthcare professional, a hospital emergency department or a regional poison control centre immediately. The Health Canada toll-free number is 1-844 POISON-X (1-844-764-7669). Do this even if there are no signs or symptoms.

Ask a health professional

This page repeats what the Canadian product monograph says. It is not medical advice. Ask your pharmacist or your prescriber what applies to you.