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 Augmentin, 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 (≥1/1000 to <1/100)
Rare (≥1/10000 to <1/1000)
Very rare (<1/10000)
Not known (cannot be estimated from the available data)

Infections and infestations
Mucocutaneous candidosis                   Common
Overgrowth of non-susceptible organisms    Not known

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 disorders8
Angioneurotic oedema                       Not known
Anaphylaxis                                Not known
Serum sickness-like syndrome               Not known
Hypersensitivity vasculitis                Not known
Nervous system disorders
Dizziness                                  Uncommon
Headache                                   Uncommon
Reversible hyperactivity                   Not known
Convulsions1                               Not known
Aseptic meningitis                         Not known

Cardiac disorders
Kounis syndrome                            Not known

Gastrointestinal disorders
Diarrhoea                                  Very common
Nausea2                                    Common
Vomiting                                   Common
Indigestion                                Uncommon
Antibiotic-associated colitis3             Not known
Drug-induced enterocolitis syndrome        Not known
(DIES)
Pancreatitis acute                         Not known
Black hairy tongue                            Not known


Hepatobiliary disorders
Rises in AST and/or ALT4                      Uncommon
Hepatitis5                                    Not known
Cholestatic jaundice5                         Not known

Skin and subcutaneous tissue disorders6
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 pustulosis      Not known
(AGEP)1
Drug reaction with eosinophilia and           Not known systemic symptoms (DRESS)
Symmetrical drug-related intertriginous       Not known and flexural exanthema (SDRIFE)
(baboon syndrome)
Linear IgA disease                            Not known

Renal and urinary disorders
Interstitial nephritis                         Not known
7
Crystalluria (including acute renal injury) Not known
1
See section 4.4
2
Nausea is more often associated with higher oral doses. If gastrointestinal reactions are evident, they may be reduced by taking amoxicillin/clavulanic acid with a meal.
3
Including pseudomembranous colitis and haemorrhagic colitis (see section 4.4) 4
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.
5
These events have been noted with other penicillins and cephalosporins (see section 4.4).
6
If any hypersensitivity dermatitis reaction occurs, treatment should be discontinued (see section 4.4).
7
See section 4.9
8
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
Additionally, you should also report to GSK Israel (il.safety@gsk.com).