Side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. With regard to the following side effects, it must be considered that they are largely dependent on the dose and that they vary from patient to patient.
The most commonly observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, melaena, heamatemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, inflammation of the stomach lining (gastritis) has been observed. Medicines such as Ibuprofen may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs. The list of the following side effects comprises all side effects that have become known under treatment with ibuprofen, also those under high dose long-term therapy in rheumatism patients.
The stated frequencies, which extend beyond very rare reports, refer to the short-term use of daily doses up to a maximum of 1,200 mg ibuprofen for oral dosage forms and a maximum of 1,800 mg for suppositories.
The side effects are stated according to the frequency they occur. The following convention has been used:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
The following side effects are important and will require immediate action if you experience them. You should stop taking Ibuprofen and see your doctor immediately if the following symptoms occur:
Common:
– black tarry stools or blood-stained vomit (digestive tract ulcer with bleeding)
Very rare:
– swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing (angioedema), rapid heartbeat, severe fall in blood pressure or life-threatening shock
– a sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure
– severe rash with blisters on the skin especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson´s syndrome). This can get even more severe; the blisters get larger and spread out and parts of the skin may slough off (Lyell´s syndrome). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle (necrotizing fasciitis).
You should stop taking the medicine and contact your doctor as soon as possible if you develop the following side effects:
Very common:
– heartburn, abdominal pain, indigestion
Uncommon:
– visual disturbances
– hypersensitivity reactions such as hives, itching, purpura, exanthema, asthma attacks (sometimes with low blood pressure)
– photosensitivity (increased sensitivity to sunlight)
Rare:
– vision loss
Very rare:
– sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain
Other possible side effects with Ibuprofen are:
Very common:
– Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation
Common:
– Digestive tract ulcer with or without perforation
– Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn’s disease) and
complications of diverticula of the large bowel (perforation or fistula)
– Microscopic bleeding from the intestine which may result in anemia
– Mouth ulcers and inflammation (ulcerative stomatitis)
– Headache, sleepiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability
Uncommon:
– Inflammation of the stomach lining
– Kidney problems including development of oedema, inflammation of the kidneys and kidney failure
– Runny nose
– Difficulty breathing (bronchospasm)
Rare:
– Depression, confusion, hallucinations
– Lupus erythematosus syndrome
– Increase of blood urea nitrogen, serum transaminases and alkaline phosphatase,
– decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease of serum calcium and increase in serum uric acid values
– Damage of the kidney tissue
Very rare:
– Unpleasant awareness of heart beat, heart failure, or heart attack
– Disorders of blood cell formation (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia)
The first symptoms or signs may include fever, sore throat, surface mouth ulcers, flulike symptoms, severe fatigue, nasal and skin bleeding)
– Ringing or buzzing in the ears
– Inflammation of the oesophagus or pancreas
– Narrowing of the bowel
– Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction, liver damage especially in long-term use or liver failure
– Hair loss
– Inflammation of the brain membrane without bacterial infection (aseptic meningitis)
Not known:
– Tingling of the hands and feet
– Anxiety
– Impaired hearing
– General feeling of being unwell
– Inflammation of the optic nerve which may cause vision problems
– A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).
– A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Ibuprofen tablets if you develop these symptoms and seek medical attention
immediately. Ibuprofen may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
