Ibuprofen Side Effects

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

Part of otc pharmacy medicine side effects side effects.

What is ibuprofen?

Ibuprofen contains the active ingredient Ibuprofen.

• Active ingredient — Ibuprofen
• Registration number — S/2.7/123
• Registration holder — Reckitt Benckiser Pharmaceuticals (Pty) Ltd

It is approved for:

• The active ingredient is ibuprofen
• Ibuprofen belongs to a group of medicines non-steroidal anti-inflammatory drugs (NSAIDs)
• These medicines provide relief by changing body’s response to pain
• NUROFEN TABLETS are used for relieving pain (including headaches, migraines, back pain, muscular aches, dental pain and menstrual pain) and fever

Common side effects of ibuprofen

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.

Less frequent side effects

• Skin rash
• Abdominal pain, nausea, diarrhoea (runny tummy), flatulence, indigestion, constipation, vomiting, black or tarry stools. Side effects with unknown frequencies:
• Photosensitivity reactions

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

• You are allergic to ibuprofen, aspirin (or other similar painkillers known as NSAIDs) or other ingredients of NUROFEN TABLETS
• You have suffered from ulcers, shortness of breath, asthma, runny nose or hives after using aspirin or other similar painkillers (NSAIDs)
• You are suffering from heart failure
• You have severe liver impairment
• You have severe kidney impairment
• You have stomach ulcers or bleeding in the gut (or you previously suffered from these)
• Children aged < 12 years old
• You are in the last trimester of pregnancy

Use with care, and tell your doctor, if

• The following conditions may be aggravated whilst on treatment with NUROFEN TABLETS, you must consult your doctor if any of the following apply to you before continuing with treatment: Problems with bleeding; Taking medicines for treating blood clotting conditions (coumarin anticoagulants); Heart disease and/ or stroke; High blood pressure; Stomach problems such as bleeding or ulcers in the gut (especially if you are an elderly); Asthma or other allergies; Using similar painkillers like aspirin (NSAIDs); Joint pain skin disorders (systemic lupus erythematosus and mixed connective tissue disease); Impaired kidneys; Liver impairment
• Treatment with NUROFEN TABLETS may lead to the following problems
• If any of the following happens, discontinue treatment and consult your doctor: Drug reaction with eosinophillia and systemic symptoms (DRESS): life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abnormal heartbeat
• Severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis: these are indicated by fever and body aches, painful/reddish rash on the skin, mouth, throat and/or genitals followed by blistering
• Fertility problems in women: NUROFEN TABLETS may cause impairment of female fertility but this is reversible upon withdrawal of treatment
• If you have been taking NUROFEN TABLETS for a couple of days and your symptoms persist or become worse as you might be suffering from an underlying infection that cannot be treated by NUROFEN TABLETS
• Your doctor will need to assess you in order to administer proper treatment for your condition

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 taking NUROFEN TABLETS
• Do not take NUROFEN TABLETS in the last trimester of pregnancy or during breastfeeding
• NUROFEN TABLETS are not recommended in pregnancy
• If you are planning to have a baby, NUROFEN TABLETS may impair your ability to fall pregnant
• However, this is reversible upon withdrawal of treatment

Interactions and medicines to check

The approved leaflet names these interactions.

• Corticosteroids (medicines for treating severe allergies and skin problems): increased risk of stomach problems
• Medicines for high blood pressure and water tablets as NUROFEN TABLETS make reduce their effect
• Medicines for treating blood clots (e.g. warfarin) due to an risk of increased of bleeding
• Antidepressants known as selective serotonin reuptake inhibitors (SSRIs) due to an risk of increased of stomach bleeding
• Medicines for treating heart failure due to worsening of heart condition
• Lithium (for depression) as lithium related side effects may be increased
• Methotrexate (for treating rheumatoid arthritis and some cancers) as co- administration may increase undesirable effects related to methotrexate
• Ciclosporin and tacrolimus (used for prevention of organ transplant) as this may lead to kidney impairment
• Mifepristone (for terminating pregnancy) because NUROFEN TABLETS can make mifepristone ineffective
• Quinolone antibiotics (e.g. levofloxacin used in the treatment of bacterial infections like pneumonia and other respiratory and urinary infections) as this may lead to seizures
• Zidovudine (for treatment of HIV infection) due to an increased risk of joint bleeds and/or swelling in people with haemophilia. NUROFEN TABLETS with food: NUROFEN TABLETS must be taken with food

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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