Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following list of adverse effects relates to those experienced with Ibuprofen at OTC doses (maximum 1200 mg Ibuprofen per day), in short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.

Adverse events which have been associated with Ibuprofen are given below, tabulated by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness. The most commonly observed adverse events are gastrointestinal in nature.


System Organ Class         Frequency                Adverse Events Blood and Lymphatic          Very rare    Haematopoietic disorders, anaemia, System Disorders                          leucopenia, thrombocytopenia, pancytopenia and agranulocytosis1
Immune System                Uncommon     Hypersensitivity with urticaria and Disorders                                 pruritus2
Very rare    Severe hypersensitivity reactions,
including facial, tongue and throat swelling, dyspnoea, tachycardia, and hypotension (anaphylaxis, angioedema or severe shock)2
Nervous System               Uncommon     Headache
Disorders                    Very rare    Aseptic meningitis3 Cardiac Disorders            Not known    Cardiac failure and oedema4 Vascular Disorders           Not known    Hypertension4
Respiratory, Thoracic and    Not known    Respiratory tract reactivity comprising Mediastinal Disorders                     asthma, bronchospasm or dyspnoea2 Gastrointestinal Disorders   Uncommon     Abdominal pain, nausea and dyspepsia5 Rare         Diarrhoea, flatulence, constipation and vomiting
Very rare    Peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena,
and haematemesis6.
Mouth ulceration and gastritis.
Exacerbation of colitis and Crohn's disease7
Hepatobiliary Disorders      Very rare    Liver disorder
Skin and Subcutaneous        Uncommon     Skin rash2

Tissue Disorders              Very rare       Bullous reactions, including Stevens- Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis2
Not known       Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Acute generalised exanthematous pustulosis (AGEP)

Photosensitivity reactions
Renal and Urinary             Very rare       Acute renal failure, papillary necrosis, Disorders                                     especially in long-term use, associated with increased serum urea and oedema8
Investigations                Very rare       Haemoglobin decreased Infections and infestations   Not known       Exacerbation of infections related inflammation has been described, in exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.


Description of Selected Adverse Reactions
1
First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
2
Hypersensitivity reactions: These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm, and dyspnoea, or (c) various skin reactions, including pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses, including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme.
3
The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with Ibuprofen in patients with existing auto-immune disorders (such as systemic lupus erythematosus and mixed connective tissue disease).
4
Clinical trial and epidemiological data suggest that use of Ibuprofen (particularly at high doses 2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke), (see section 4.4).
5
The adverse events observed most often are gastrointestinal in nature.
6
Sometimes fatal.
7
See section 4.4.
8
Especially in long-term use, associated with increased serum urea and oedema.
Also includes papillary necrosis.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il