Ozempic Side Effects

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

Part of diabetes & weight management side effects.

What is Ozempic?

Ozempic contains the active ingredient Semaglutide.

• Active ingredient — Semaglutide
• Registration number — 53/21.13/0497
• Registration holder — Novo Nordisk (Pty) Ltd

It is approved for:

• on its own if your blood sugar is not controlled well enough by diet and exercise alone, or
• with other medicines for diabetes – when they are not enough to control your blood sugar levels. These other medicines may include: oral antidiabetics (such as metformin, thiazolidinedione medicines (TZDs), sulfonylurea medicines, SGLT2 inhibitors) or insulin. Ozempic® is used to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease. It is important that you keep following your diet and lifestyle advice received from your healthcare professional while using Ozempic®

Common side effects of Ozempic

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)
• 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
• feeling dizzy
• feeling tired
• weight loss
• less appetite
• gas (flatulence)
• increase of pancreatic enzymes (such as lipase and amylase)
• complications of diabetic eye disease (retinopathy)

Less frequent side effects

• change in the way food or drink tastes
• fast pulse
• injection site reactions – such as bruising, pain, irritation, itching and rash
• allergic reactions like rash, itching or hives. If you get any side effects, talk to your doctor, pharmacist or other healthcare professional. This includes any possible side effects not listed in this leaflet

Serious side effects and warning signs

The leaflet lists these as serious side effects needing immediate attention.

Less frequent

• 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?

What the approved leaflet says about dosing and duration:

• The starting dose is 0,25 mg once a week for four weeks, increasing to 0,5 mg once a week; the doctor may increase to 1 mg once a week if blood sugar is not controlled well enough.
• The leaflet does not state how long individual side effects last.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

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®
• Lumps in your neck may be due to a problem developing in your thyroid gland. Consult your doctor if you feel a lump developing
• Children and adolescents Ozempic® is not recommended in children and adolescents under 18 years as the safety and efficacy in this age group have not yet been established. Using Ozempic® with food and drink: Ozempic® may be taken with or without meals

Pregnancy and breastfeeding

• Tell your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant
• Ozempic® should not be used during pregnancy and for at least two months before a planned pregnancy because it is not known if it may affect your unborn child
• If you could become pregnant while using Ozempic®, you should use effective contraception
• Do not use this Ozempic® if you are breast-feeding
• This is because Ozempic® may pass into breast milk

Interactions and medicines to check

The approved leaflet names these interactions.

• sulfonylurea
• insulin Combining these medicines with Ozempic® might increase the risk of getting low blood sugar (hypoglycaemia). Please see section ‘POSSIBLE SIDE EFFECTS’ for the warning signs of low blood sugar. Your doctor may tell you to test your blood sugar levels. This will help your doctor decide if the dose of the sulfonylurea or insulin needs to be changed to reduce the risk of low blood sugar

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.

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