GLP-1 medicines Side Effects

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Answer the side-effect intent for glp-1 medicines without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of diabetes & weight management side effects.

What is GLP-1 medicines?

GLP-1 medicines covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• semaglutide — Ozempic, Novo Nordisk (Pty) Ltd (Solution for injection (injection).)
• liraglutide — GILIPTRA, Cipla Medpro (Pty) Ltd (Solution for injection in a pre-filled pen)
• dulaglutide — TRULICITY, Eli Lilly (S.A.) (Pty) Limited (Solution for Injection)
• lixisenatide — SOLIQUA, sanofi-aventis south africa (pty) ltd (Solution for injection)

Common side effects of GLP-1 medicines

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Semaglutide (Ozempic)

• feeling sick (nausea)
• diarrhoea
• low blood sugar (hypoglycaemia) when OZEMPIC® is used with a sulfonylurea or insulin. The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating or shaking. Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs
• being sick (vomiting)
• indigestion
• inflamed stomach (‘gastritis’) – the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
• reflux or heartburn – also called ‘gastro-esophageal reflux disease’ (GERD)
• stomach pain
• bloating of the stomach
• constipation
• burping
• gall stones

The leaflet lists 11 more. Read the full leaflet.

Liraglutide (GILIPTRA)

• 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)

The leaflet lists 17 more. Read the full leaflet.

Dulaglutide (TRULICITY)

• Severe allergic reactions (anaphylactic reactions, angioedema). You should see a doctor immediately if you experience symptoms such as rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat, hives and difficulties breathing
• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms. Not known: the frequency cannot be estimated from the available data:
• Bowel obstruction – a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting. You should see a doctor immediately if you experience such symptoms. Other side effects Very common: may affect more than 1 in 10 people
• Nausea (feeling sick)
• Vomiting (being sick)
• Diarrhoea
• Abdominal (stomach) pain. These side effects are usually not severe. They are most common when first starting TRULICITY but decrease over time in most patients
• Hypoglycaemia (low blood sugar) is very common when TRULICITY is used with medicines that contain metformin, a sulphonylurea and/or insulin. Common: may affect up to 1 in 10 people
• Hypoglycaemia is common when TRULICITY is used alone, or with both metformin and pioglitazone together, or with a sodium-glucose co-transporter 2 inhibitor (SGLT2i) with or without metformin
• Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar
• Feeling less hungry (decreased appetite)
• Indigestion

The leaflet lists 15 more. Read the full leaflet.

Lixisenatide (SOLIQUA)

• feeling dizzy
• feeling sick (nausea)
• vomiting
• diarrhoea
• cold, runny nose, sore throat
• hives (urticaria)
• headache
• indigestion (dyspepsia)
• stomach ache
• tiredness
• changes where the injection is given: if you injection SOLIQUA too often in the same place, you may develop dents at the site, caused by a loss of fat under the skin (lipoatrophy) or you may develop lumps, caused by a build-up of fat under the skin (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (localised cutaneous amyloidosis). SOLIQUA may not work very well. Change the injection site with each injection to help prevent these changes
• skin and allergic reactions at the injection site: the signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation. This can spread around the injection site. Most minor reactions to insulins usually disappear in a few days to a few weeks

The leaflet lists 2 more. Read the full leaflet.

Serious side effects and warning signs

Effects the leaflets single out as needing prompt attention.

Semaglutide (Ozempic)

• Severe allergic reactions (anaphylactic reactions, angioedema). You should seek immediate medical help and inform your doctor straight away if you get symptoms such as breathing problems, swelling of face, lips, tongue and/or throat with difficulty swallowing and a fast heartbeat
• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. You should see a doctor immediately if you experience such symptoms

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

Cautions from each medicine’s approved leaflet.

Semaglutide (Ozempic)

Do not use it at all if:

• if you are allergic to semaglutide or any of the other ingredients of this medicine (listed under ‘WHAT Ozempic® CONTAINS’)
• if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• if you are pregnant
• if you are breastfeeding your baby Women who may become pregnant should use effective contraception while taking Ozempic

Use with care, and tell your doctor, if:

• you have type 1 diabetes – your body does not produce any insulin
• you have diabetic ketoacidosis – a complication of diabetes that happens when the body is not able to break down glucose because there is not enough insulin
• Severe and on-going stomach pain which could be due to acute pancreatitis If you have severe and on-going pain in the stomach area
• see a doctor straight away as this could be a sign of acute pancreatitis (inflamed pancreas)
• Dehydration During treatment with Ozempic®, you may experience feeling sick (nausea) or being sick (vomiting), and diarrhoea. These side effects can cause dehydration (loss of fluids). It is therefore important to drink plenty of fluids to prevent dehydration. Talk to your doctor if you have any questions or concerns
• Diabetic eye disease (retinopathy) Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. This may require treatment or lead to a loss of vision. You should inform your doctor if you have diabetic eye disease (retinopathy) or if you experience eye problems during treatment with Ozempic®

Liraglutide (GILIPTRA)

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

Dulaglutide (TRULICITY)

Do not use it at all if:

• If you are hypersensitive (allergic) to dulaglutide or any of the other ingredients of TRULICITY (listed in section 6)
• If you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• If you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away
• If you have type 1 diabetes (the type when your body does not produce any insulin) as TRULICITY may not be right for you
• If you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat
• If you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis)

Use with care, and tell your doctor, if:

• you are on dialysis as TRULICITY is not recommended
• you have type 1 diabetes (the type when your body does not produce any insulin) as TRULICITY may not be right for you
• you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin). The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat
• you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• you have severe problems with food digestion or food remaining in your stomach for longer than normal (including gastroparesis)
• you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away

Lixisenatide (SOLIQUA)

Do not use it at all if:

• if you are hypersensitive (allergic) to insulin glargine, lixisenatide or any of the other ingredients of SOLIQUA (listed in section 6)
• if you are pregnant or breastfeeding
• if you are experiencing episodes of hypoglycaemia
• if you have sudden inflammation of your pancreas including symptoms such as severe stomach pain, fever, rapid pulse, nausea and vomiting
• if you have severe kidney problems or kidney disease
• if you have type 1 diabetes, as SOLIQUA is used for type 2 diabetes and this medicine will not be right for you

Use with care, and tell your doctor, if:

• Too low blood sugar (hypoglycaemia). If your blood sugar is too low, follow the guidance for hypoglycaemia
• Too high blood sugar (hyperglycaemia). If your blood sugar is too high, follow the guidance for hyperglycaemia
• Ensure that you use the right medicine. You must always check the label before each injection to avoid mix-ups between SOLIQUA and other insulins. While using this medicine be aware of the following and talk to your doctor, pharmacist or other health care provider before using SOLIQUA:
• Severe pain in your stomach area (abdomen) that will not go away. This could be a sign of inflamed pancreas (acute pancreatitis). Also, tell your doctor if you have a history of pancreatitis
• Loss of fluid from your body (dehydration), e.g. in case of vomiting and diarrhoea. It is important to avoid dehydration by drinking plenty of fluids, especially during the first weeks of treatment with SOLIQUA
• If you develop skin changes at the injection site. The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area. Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medicine dose

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

• Ozempic side effects

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