Adverse reactions : תופעות לוואי

4.8    Undesirable effects

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

Adverse events which have been associated with ibuprofen are given below, tabulated by system organ class and frequency.
The frequencies are defined as follows:

Very common (≥1/10)
Common (≥1/100 to <1/10)

Uncommon (≥1/1000 to <1/100)
Rare (≥1/10000 to <1/1000) Very

Rare (<1/10000)

Not known (cannot be estimated from the available data)
Within each frequency grouping, adverse events are presented in order of decreasing seriousness.


System Organ Class           Frequency                   Adverse Event 

Blood and Lymphatic                             Haematopoietic disorders1 Very rare
System Disorders


Hypersensitivity reactions with Urticaria and
Uncommon pruritus2
Immune System Disorders                         Severe hypersensitivity reactions, including facial, tongue and throat swelling,
Very rare       dyspnoea, tachycardia and hypotension
(anaphylaxis, angioedema or severe shock)2

Nervous System Disorders        Uncommon        Headache

Very rare       Aseptic meningitis3
Cardiac Disorders               Very rare       Cardiac failure and oedema4 

Vascular Disorders              Very rare       Hypertension4
Respiratory tract reactivity compromising
Respiratory, Thoracic and
Very rare       asthma, aggravated asthma, bronchospasm or
Mediastinal Disorders dyspnoea2
Uncommon        Abdominal pain, nausea and dyspepsia5
Rare            Diarrhoea, flatulence, constipation and vomiting

Gastrointestinal                                Peptic ulcer, gastrointestinal perforation or Disorders                                       gastrointestinal haemorrhage, melaena and Very rare       haematemesis6. Exacerbation of colitis and Crohn's disease7. Mouth ulceration and gastritis
Liver disorder8
Hepatobiliary
Very rare       Cholestatic jaundice, hepatitis, elevation of serum
Disorders enzymes
Uncommon        Skin rash2
Skin and
Subcutaneous Tissue                             Severe forms of skin reactions such as erythema Disorders                       Very rare       multiforme, epidermal necrolysis and Stevens- Johnson syndrome2
Not known         DRESS syndrome: Drug reaction with eosinophilia and systemic symptoms

Acute generalised exanthematous pustulosis (AGEP)

Photosensitivity reactions
Renal and Urinary Disorders
Very rare         Acute renal failure9
Haemoglobin decreased, urea renal clearance
Investigations                    Very rare decreased
Exacerbation of infections related inflammation (e.g.
development of necrotizing fasciitis), in exceptional
Infections and infestations                         cases, severe skin infections and soft-tissue Very rare complications may occur during a varicella infection


Description of Selected Adverse Reactions
1
Examples include anaemia, leucopenia, thrombocytopenia, pancytopenia and agranulocytosis. First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.

2Hypersensitivity 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, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.
4
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg 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, particularly in the elderly (see section 4.4).
7
See section 4.4.
8
Especially in long-term treatment.
9
Decrease of urea excretion and oedema can occur. Papillary necrosis, especially in long- term use, and increased serum urea concentrations have been reported.

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