Wegovy Side Effects

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

Part of diabetes & weight management side effects.

What is Wegovy?

Wegovy contains the active ingredient Semaglutide.

• Active ingredient — Semaglutide
• Registration number — 58/21.013/0223; 58/21.013/0224; 58/21.013/0225; 58/21.013/0226
• Registration holder — Novo Nordisk (Pty) Ltd

It is approved for:

• a BMI of 30 kg/m² or greater (obesity) or
• a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems). BMI (Body Mass Index) is a measure of your weight in relation to your height. WEGOVY® is used together with diet and physical activity for weight management in adolescents ages 12 years and above, who have
• obesity and
• body weight > 60 kg

Common side effects of Wegovy

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.

Reported side effects

• Complications of diabetic eye disease (diabetic retinopathy). If you have diabetes, you should inform your doctor if you experience eye problems, such as changes in vision, during treatment with this medicine. Uncommon (may affect up to 1 in 100 people)
• Inflamed pancreas (acute pancreatitis). Signs of inflamed pancreas may include severe and long-lasting pain in your stomach, the pain may move to your back. You should see your doctor immediately if you experience such symptoms
• 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 difficulty, swelling, light-headedness, fast heartbeat, sweating and loss of consciousness or rapid swelling under the skin in areas such as the face, throat, arms and legs, which can be life threatening if throat swelling blocks the airway
• These are all very serious side effects. If you have them, you may have had a serious reaction to WEGOVY®. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• chest pain
• angina
• changes in the way your heart beats, for example, if you notice it beating faster
• difficulty breathing
• signs of recurrent infections such as fever or sore throat
• less urine than is normal for you
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems These are all serious side effects
• You may need urgent medical attention. Tell your doctor if you notice any of the following:
• headache
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea
• constipation
• stomach pain
• feeling weak or tired Common (may affect up to 1 in 10 people)
• feeling dizzy
• upset stomach or indigestion
• burping
• gas (flatulence)
• bloating of the stomach
• inflamed stomach (‘gastritis’) – the signs include stomach-ache, feeling sick (nausea) or being sick (vomiting)
• reflux or heartburn – also called ‘gastro-oesophageal reflux disease’
• gallstones
• hair loss
• injection site reactions
• low blood sugar (hypoglycaemia) in patients with type 2 diabetes
• low blood pressure
• feeling dizzy or lightheaded on standing or sitting up because of a drop in blood pressure
• fast heartbeat
• increase of pancreatic enzymes (such as lipase and amylase) shown in blood tests

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 are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 6)

Use with care, and tell your doctor, if

• use other products for weight loss
• have type 1 diabetes
• have severely reduced kidney function
• have severely reduced liver function
• have severe heart failure
• have diabetic eye disease (retinopathy). There is little experience with WEGOVY® in patients:
• of 75 years and older
• with liver problems
• with severe stomach or gut problem which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease
• Dehydration During treatment with WEGOVY®, you may feel sick (nausea) or be sick (vomiting) or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration
• This is especially important if you have kidney problems. Talk to your doctor if you have any questions or concerns
• Inflammation of the pancreas If you have severe and on-going pain in the stomach area – see a doctor straight away as this could be a sign of inflamed pancreas (acute pancreatitis)
• People with type 2 diabetes WEGOVY® cannot be used as a substitute for insulin. Do not use WEGOVY® in combination with other medicines that contain GLP-1 receptor agonists (such as liraglutide, dulaglutide, exenatide or lixisenatide)
• Low blood sugar (hypoglycaemia) Taking a sulfonylurea or an insulin with WEGOVY® might increase the risk of getting low blood sugar levels (hypoglycaemia). Please Your doctor may ask 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
• Diabetic eye disease (retinopathy) If you have diabetic eye disease and are using insulin, this medicine may lead to a worsening of your vision, and this may require treatment. Fast improvements in blood sugar control may lead to a temporary worsening of diabetic eye disease. If you have diabetic eye disease and experience eye problems while taking this medicine, talk to your doctor. Children and adolescents The safety and efficacy of WEGOVY® in children below 12 years of age have not been studied and are not recommended for use in this population

Pregnancy and breastfeeding

• This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child
• Therefore, it is recommended to use contraception while using this medicine
• If you wish to become pregnant, you should stop using this medicine at least two months in advance
• If you become or are pregnant, think you may be pregnant or are planning to have
• Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk

Interactions and medicines to check

The approved leaflet names these interactions.

• Warfarin or other similar medicines taken by mouth to reduce blood clotting (oral anti- coagulants). When you start treatment with e.g., warfarin or similar medicines, frequent blood testing to determine the ability of your blood to clot may be required

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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