Saxenda Side Effects

Home › Medicine Side Effects › Saxenda

Answer the side-effect intent for saxenda without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Saxenda?

Saxenda contains the active ingredient Liraglutide.

• Active ingredient — Liraglutide
• Registration number — 58/21.13/0001
• Registration holder — Cipla Medpro (Pty) Ltd

It is approved for:

• GILIPTRA contains a medicine called liraglutide which reduces your blood sugar level when blood sugar is too high
• GILIPTRA is indicated as an adjunct to diet and exercise to achieve glycaemic control for the treatment of the type of diabetes called ‘type 2 diabetes mellitus’
• GILIPTRA is indicated for once-daily administration as: o Monotherapy o combination therapy with one or more oral antidiabetic medicines (metformin, sulphonylureas, sodium-glucose cotransporter 2 inhibitor (SGLT2i) or a thiazolidinedione) when previous therapy does not achieve adequate glycaemic control. o Combination therapy with insulin in patients not achieving adequate glycaemic control with GILIPTRA and metformin

Common side effects of Saxenda

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Feeling sick (nausea). This usually goes away over time
• Diarrhoea
• Headache
• Being sick (vomiting)
• Burping
• Indigestion
• Inflamed stomach (gastritis). The signs include stomach pain, feeling sick (nausea) and being
• sick (vomiting)
• Gastro-oesophageal reflux disease (GORD), that includes heartburn
• Painful or swollen tummy (abdomen)
• Constipation
• Wind (flatulence)
• Anorexia
• Decreased appetite
• Infection of the upper airways
• Low blood sugar (hypoglycaemia). The warning signs of low blood sugar may come on suddenly and can include: o cold sweat, cool pale skin, o headache, o fast heart beat, o feeling sick, o feeling very hungry, o changes in vision, o feeling sleepy, o feeling weak, nervous, anxious, or confused, o difficulty concentrating, o shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. If you are already taking a sulphonylurea medicine when you start using GILIPTRA, your doctor may tell you to reduce the dose of the sulphonylurea medicine

Less frequent side effects

• Pancreatitis (inflammation of the pancreas). Pancreatitis can be a serious, potentially life- threatening medical condition
• Stop taking GILIPTRA and contact a doctor immediately if you notice any of the following serious side effects: severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis)
• Thyroid events – like nodules, increased blood calcitonin, goitres and cancer
• increased pulse rate
• urticaria (a type of rash)
• pruritus (itching)
• malaise (feeling unwell)
• dehydration, sometimes with a decrease in kidney function
• injection site reactions (such as bruising, pain, irritation, itching and rash)
• Increased lipase (enzyme the body uses to break down fats in food so they can be absorbed in the intestines) / amylase (an enzyme that allows the body to change some substances into simple sugars)
• Fatigue (feeling tired)
• Cholelithiasis/Cholecystitis (Gallstones/inflamed gallbladder) Side effects with unknown frequency:
• Lumps under the skin may be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). GILIPTRA may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent this skin change. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• − if you have type 1 diabetes mellitus (your body does not produce any insulin)
• − if you are hypersensitive (allergic) to liraglutide or any of the other ingredients of GILIPTRA (listed in section 6) − if you are pregnant or intend to become pregnant or breastfeeding
• − if you previously had an inflammation of the pancreas

Use with care, and tell your doctor, if

• if you have or have had a disease of the pancreas (inflammation of the pancreas). If you have thyroid disease including thyroid nodules and enlargement of the thyroid gland
• If you have severe kidney disease or are on dialysis
• There is no experience with GILIPTRA in patients with severe kidney problems
• The use of GILIPTRA is not recommended if you have severe heart failure
• GILIPTRA is not recommended if you have a severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or inflammatory bowel disease. If you have symptoms of acute pancreatitis, such as persistent, severe stomach-ache, you should tell your doctor or healthcare professional immediately
• When initiating treatment with GILIPTRA, you may experience loss of fluids/dehydration, e.g., in case of vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids. Tell your doctor or healthcare professional if you have any questions or concerns. Children and adolescents GILIPTRA is not recommended for children and young people under 18 years

Pregnancy and breastfeeding

• − If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before using GILIPTRA
• − GILIPTRA is contraindicated in pregnancy and breastfeeding
• − You should not use GILIPTRA if you are pregnant or breastfeeding your baby
• If you are being treated with GILIPTRA, you should not breastfeed your baby
• − If you are pregnant or breastfeeding your baby while using GILIPTRA please consult your doctor, pharmacist or other healthcare professional for advice

Interactions and medicines to check

The approved leaflet names these interactions.

• Insulin
• A sulphonylurea medicine (such as glimepiride or glibenclamide)
• This is because using GILIPTRA at the same time may cause your blood sugar to get too low (hypoglycaemia)
• When you first start using these medicines together, your doctor may tell you to lower the dose of the sulphonylurea medicine
• If you are not sure if the medicines you are taking contain a sulphonylurea, ask your doctor or pharmacist. GILIPTRA with food, drink, and alcohol You can use GILIPTRA at any time of the day. It does not matter when you take it in relation to meals

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

Related pages

• minoxidil side effects

← Back to more medicine side effects.