Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and vomiting.
The ADRs derived from clinical studies and post-marketing surveillance with amoxicillin/clavulanic acid, sorted by MedDRA System Organ Class are listed below.

The following terminologies have been used in order to classify the occurrence 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)

Infections and infestations
Mucocutaneous candidosis                   Common
Overgrowth of non-susceptible        Not known organisms
Blood and lymphatic system disorders
Reversible leucopenia (including     Rare neutropenia)
Thrombocytopenia                     Rare
Reversible agranulocytosis           Not known
Haemolytic anaemia                   Not known
Prolongation of bleeding time and    Not known prothrombin time1
Immune system disorders10
Angioneurotic oedema                 Not known
Anaphylaxis                          Not known
Serum sickness-like syndrome         Not known
Hypersensitivity vasculitis          Not known
Nervous system disorders
Dizziness                            Uncommon
Headache                             Uncommon
Convulsions2                         Not known
Aseptic meningitis                   Not known
Vascular disorders
Thrombophlebitis3                    Rare
Gastrointestinal disorders
Diarrhoea                            Common
Nausea                               Uncommon
Vomiting                             Uncommon
Indigestion                          Uncommon
4
Antibiotic-associated colitis        Not known
Drug-induced enterocolitis syndrome  Not known
Pancreatitis acute                   Not known
Hepatobiliary disorders
Rises in AST and/or ALT5             Uncommon
Hepatitis6                           Not known
Cholestatic jaundice6                Not known
Skin and subcutaneous tissue disorders7
Skin rash                            Uncommon
Pruritus                             Uncommon
Urticaria                            Uncommon
Erythema multiforme                  Rare
Stevens-Johnson syndrome             Not known
Toxic epidermal necrolysis           Not known
Bullous exfoliative-dermatitis       Not known
Acute generalised exanthemous        Not known pustulosis (AGEP)9
Drug reaction with eosinophilia and  Not known systemic symptoms (DRESS)
Linear IgA disease                   Not known
Renal and urinary disorders
Interstitial nephritis               Not known
8
Crystalluria (including acute renal  Not known injury)
Cardiac disorders
Kounis syndrome                      Not known
1 See section 4.4
2 See section 4.4
3 At the site of injection
4 Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4)
5 A moderate rise in AST and/or ALT has been noted in patients treated with beta- lactam class antibiotics, but the significance of these findings is unknown.
6 These events have been noted with other penicillins and cephalosporins (see section 4.4).
7 If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4).
8 See section 4.9
9 See section 4.4
10 See sections 4.3 and 4.4

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