The following convention has been utilised for the classification 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).
Unless otherwise stated, the frequency of the adverse events has been derived from more than 30 years of post-marketing reports
Blood and lymphatic system disorders
Very rare: neutropenia (including agranulocytosis) and thrombocytopenia. These are reversible when treatment is discontinued. Eosinophilia, haemolytic anaemia.
Immune system disorders
Very rare: anaphylactic shock (exceptional with oral administration) (see section 4.4), angioneurotic oedema.
If any hypersensitivity reaction occurs, the treatment should be discontinued (see also skin and subcutaneous tissue disorders).
Nervous system disorders
Very rare: in patients suffering from renal failure, neurological disorders with convulsions are possible with the I.V. injection of high doses.
*Common: minor gastrointestinal disturbances
Very rare: pseudomembranous colitis
If pseudomembranous colitis develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.
Very rare: hepatitis and cholestatic jaundice. (see section 4.4). Changes in liver function laboratory test results (reversible when treatment is discontinued).
These reactions are related neither to the dose nor to the route of administration. The onset of these effects may be delayed for up to two months post-treatment; in several cases the course of the reactions has been protracted and lasted for some months. Hepatic events may be severe and in very rare circumstances a fatal outcome has been reported. Most reports of deaths have been in patients ≥ 50 years and in patients with serious underlying disease.
Skin and subcutaneous tissue disorders
*Uncommon: rash, urticaria and purpura.
Very rare: erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (see also immune system disorders).
Frequency not known: AGEP - acute generalized exanthematous pustulosis (See section 4.4)
Musculoskeletal and connective tissue disorders
Very rare: arthralgia and myalgia sometimes develop more than 48 hours after the start of the treatment.
Renal and urinary disorders
Very rare: interstitial nephritis. This is reversible when treatment is discontinued.
General disorders and administration site conditions
Very rare: fever sometimes develops more than 48 hours after the start of the treatment.
*The incidence of these AEs was derived from clinical studies involving a total of approximately 929 adults and paediatric patients taking flucloxacillin
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: email@example.com.