Nexium Side Effects

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

What is Nexium?

Nexium contains the active ingredient Esomeprazole.

• Active ingredient — Esomeprazole
• Registration number — 35/11.4.3/0263; 35/11.4.3/0264
• Registration holder — AstraZeneca Pharmaceuticals (Pty) Ltd

It is approved for:

• Inflammation (swelling) and pain in the food pipe caused by a return flow of acidic fluid from the stomach (erosive reflux oesophagitis)
• Disease with symptoms e.g. heartburn and regurgitation, caused by a return flow of acidic fluid from the stomach (symptomatic treatment of gastro-oesophageal reflux disease – GORD) and the prevention of this condition from happening again
• Prevention of ulcers caused by a medicine used for pain and inflammation
• Infection with bacteria called Helicobacter pylori that cause ulcers in the stomach in combination with appropriate antibiotics
• A hypersecretory condition which causes excess secretion of acid in the stomach known as Zollinger-Ellison Syndrome

Common side effects of Nexium

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

• Headache
• stomach pain
• diarrhoea
• wind
• feeling sick/being sick
• constipation

Less frequent side effects

• Skin reactions (rash, dermatitis, itching, hives [itchy bumps])
• sensation of burning/prickling/numbness
• difficulty sleeping
• feeling sleepy
• dizziness
• vertigo
• dry mouth and peripheral swelling
• blurred (decreased clarity) vision
• severe allergic reactions (swelling, anaphylactic reaction/shock)
• muscular pain
• blood disorders (reduced number of cell in blood i.e. leukopenia and thrombocytopenia)
• depression
• low blood sodium
• nervousness
• confusion
• taste disorders
• tightness in the chest
• inflammation in the mouth
• gastrointestinal fungal infection
• gastrointestinal infection
• inflammation of the liver (with or without jaundice)
• hair loss
• sensitivity to sunlight
• sore joints
• feeling ill and increased sweating may occur
• severe skin disorders
• other blood disorders (agranulocytosis and pancytopenia)
• aggression
• hallucination
• impaired liver function
• decreased consciousness
• muscular weakness
• inflammation of the kidney
• development of breasts in males
• low blood magnesium (which may result in low blood calcium and/or low blood potassium)
• inflammation in the gut (leading to diarrhoea)
• fracture of your hip, wrist or spine. The following side effect may also occur with NEXIAM. This would only be seen when a blood test is taken: increase in the amount of liver enzymes

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 hypersensitive (allergic) to esomeprazole or any of the other ingredients of NEXIAM (listed in section 6)
• If you are allergic to other “proton pump inhibitors”
• If you are taking medicine for HIV treatment (atazanavir or nelfinavir)

Use with care, and tell your doctor, if

• if you notice any of the following: o if you feel that you are losing weight without trying to lose it. o you begin to vomit blood or food. o you pass black (blood-stained) stools. You should contact your doctor immediately
• if you are taking any of the following medicines: medicines used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety medicine (diazepam), medicines used to prevent fitting (phenytoin), medicines used to prevent blood clotting (warfarin, clopidogrel), intermittent claudication (cilostazol), medicines used to speed up stomach emptying (cisapride) and if you are using a certain type of antimalignancy medicine (such as erlotinib or another antimalignancy medicine from the same class)
• if you have severe liver problems. You should discuss this with your doctor, as he/she may wish to reduce the dose
• if you have severe kidney problems. You should discuss this with your doctor
• If you have severe, debilitating diarrhoea (known as Clostridium Difficile- associated diarrhoea, Salmonella or Campylobacter), that does not improve. Symptoms may include watery stools, stomach pain and fever
• If you experience any severe, painful, blistering or peeling skin rash (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms). You should stop taking NEXIAM and contact your doctor immediately
• If you experience low levels of magnesium in your body. Symptoms include tiredness, muscles spasms, disorientation, convulsions (fits), dizziness and an abnormal heartbeat. Your doctor may conduct regular blood tests to monitor your magnesium levels. Proton pump inhibitors (like NEXIAM) may be associated with a small increased risk for osteoporotic bone fractures (osteoporosis is a condition where certain bones become brittle). Please inform your doctor if you have been diagnosed with osteoporosis (brittle bone disease)

Pregnancy and breastfeeding

• You should not take NEXIAM if you are pregnant or breastfeeding your baby
• 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 taking NEXIAM

Interactions and medicines to check

The approved leaflet names these interactions.

• The medicine’s effects may be influenced if NEXIAM is taken at the same time as some medicines used to prevent fungal infections (itraconazole, ketoconazole voriconazole), anxiety medicine (diazepam), medicines used to prevent fitting (phenytoin), medicines used to prevent blood clotting (warfarin or clopidogrel), intermittent claudication [muscle pain that happens in your legs when you are active and then stops when you rest] (cilostazol), transplant rejection (tacrolimus), medicines used to speed up stomach emptying (cisapride), heart problems (digoxin), and also if you are using treatment for tuberculosis (rifampicin), St. John’s wort (Hypericum perforatum) (used to treat depression), or certain type of antimalignancy medicines (such as erlotinib or another antimalignancy medicine from the same class)
• NEXIAM should not be taken at the same time as protease inhibitors (medicines for HIV infection), e.g. indinavir, atazanavir and nelfinavir, as NEXIAM may reduce the blood levels of protease inhibitors
• If you are taking a high dose of methotrexate (a chemotherapy medicine in which high dose is used to treat cancer), NEXIAM may need to be temporarily withdrawn
• NEXIAM may affect the way that your body absorbs vitamin B12, particularly if you need to take it for a long time
• NEXIAM may interfere with laboratory tests to investigate neuroendocrine tumours. Your doctor will instruct you to stop taking NEXIAM 5 days before the tests are done

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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