Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Systemic availability of topical ibuprofen is very low compared to orally administered NSAIDs.
Adverse events, particularly those affecting the gastrointestinal tract, are less common with the use of topical ibuprofen.
The list of the following adverse events relates to those experienced with topical ibuprofen at OTC (dose maximum 500 mg per day), in short term use.
The following frequency conventions are used in the rating of undesirable effects: Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000); 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 Events Immune System Disorders           Not known                         Hypersensitivity 1 Gastrointestinal Disorders        Not known                         Abdominal pain, dyspepsia Renal and Urinary Disorders       Not known                         Renal impairment 2 General Disorders and             Not known                         Application site reaction 3 Administration Site conditions
Skin and subcutaneous             Not known                         Photosensitivity reactions tissue disorders
1
Hypersensitivity reactions have been reported following treatment with oral ibuprofen. These may consist of (a) non-specific allergic reaction and anaphylaxis, (b) respiratory tract reactions comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) skin reactions, including rashes of various types, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis, Stevens-Johnson Syndrome and erythema multiforme), and pruritus.
2
Renal impairment may occur following the use of topical ibuprofen, particularly in those with pre-existing renal dysfunction.
3
The most common undesirable effects are application site reactions.


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