Adverse reactions : תופעות לוואי

4.8. Undesirable effects
The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
The adverse effects have been listed in order of decreasing frequency, using the following convention: 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).

Investigations:               Very rare:                     Decreased haematocrit and haemoglobin levels.

Cardiac Disorders:            Not known:                     Oedema, hypertension, angina pectoris and cardiac failure,
have been reported in association with NSAID treatment.
Kounis syndrome.

Clinical studies suggest that use of ibuprofen (particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events
(for example myocardial infarction or stroke) (see section 4.4).

Blood and Lymphatic           Very rare:                     Haematopoietic disorders System Disorders:                                            (anaemia, haemolytic anaemia, aplastic anaemia,
leucopenia,
thrombocytopenia,
pancytopenia,
agranulocytosis). First signs are: fever, sore throat,
superficial mouth ulcers,
influenza-like symptoms,
severe exhaustion,
unexplained bleeding and bruising.

Nervous System Disorders:     Uncommon:                      Headache, dizziness, cerebrovascular accident

Very rare:                     Aseptic meningitis – single cases have been reported very rarely.

Eye Disorders:                Very rare:                     Visual impairment 
Ear and Labyrinth             Very rare:                     Tinnitus and vertigo.
Disorders:

Respiratory, Thoracic         Very rare:                     Asthma, bronchospasm, and Mediastinal                                              dyspnoea and wheezing.
Disorders:

Gastrointestinal                                             The most commonly- Disorders:                                                   observed adverse events are gastrointestinal in nature.

Uncommon:    Abdominal pain, abdominal distension, nausea and dyspepsia.

Rare:        Diarrhoea, flatulence,
constipation and vomiting.
Very rare:   Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly, ulcerative stomatitis, gastritis, mouth ulcer.

Not known:   Exacerbation of colitis and
Crohn’s disease (see section 4.4).

Renal and Urinary       Very rare:   Acute renal failure,
Disorders:                           tubulointerstitial nephritis,
nephritic syndrome,
papillary necrosis, especially in long-term use, associated with increased serum urea and oedema; haematuria and proteinuria.
Skin and Subcutaneous   Uncommon:    Various skin rashes
Tissue Disorders:

Very rare:   Severe cutaneous adverse reactions (SCARs)
(including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson
Syndrome, and toxic epidermal necrolysis.

Not known:   Drug reaction with eosinophilia and systemic symptoms
(DRESS syndrome)
Acute generalised exanthematous pustulosis
(AGEP)
Photosensitivity reactions.
Infections and          Not known:   Meningitis, aseptic
Infestations:                        meningitis.

Vascular Disorders:     Very rare:   Hypertension.

General Disorders and   Very rare:   Oedema, swelling and
Administration Site                  peripheral oedema.
Conditions:
Immune System Disorders:        Uncommon:                       Hypersensitivity reactions with urticaria and pruritis.

Very rare:                      Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling,
dyspnoea,
tachycardia, hypotension
(anaphylaxis, angioedema or severe shock).

Not known:                      Non-specific allergic reactions
Respiratory tract reactivity
(e.g. asthma, aggravated asthma and bronchospasm).
Various skin reactions including exfoliative and bullous dermatoses
(including epidermal necrolysis and erythema multiforme).
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 (see section
4.4).
Hepatobiliary Disorders:        Very rare:                      Liver disorders, hepatitis and jaundice.

Psychiatric Disorders:          Very rare:                      Nervousness.

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)