Adverse reactions : תופעות לוואי

4.8.   Undesirable effects
Cloxacillin, as other penicillins produces rarely adverse reactions and they are usually mild and ephemeral.
Adverse reactions listed below are classified according to frequency and System Organ Class (SOC). Frequency categories are defined according to 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).


Blood and lymphatic system disorders
Not known: Hematological reactions which are reversible including anemia, thrombopenia and leucopenia.

Immune system disorders
Very rare: anaphylactic shock.
Not known: Allergic reactions have been reported whose symptoms are fever, urticarial rash, eosinophilia, Quincke’s edema,


Nervous system disorders:
Not known: High dosage of cloxacillin given to patients especially to those with renal insufficiency, may induce encephalopathies which includes conscience troubles, non-physiological movement and sudden attacks of convulsion.


Gastrointestinal disorders
Rare: pseudo membranous colitis; in such case the uptake of cloxacillin should be discontinued.
Not known: nausea, vomiting, diarrhea.

Hepatobiliary disorders
Very rare: Augmentation of the transaminase enzymes ASAT and ALAT and hepatic icterus.
Not known: Cholestatic jaundice.

Skin and subcutaneous tissue disorders
Very rare: Stevens-Johnson syndrome and polymorph erythema
Not known: Skin rashes maculopapular which may be of allergic origin or not 

Renal and urinary disorders
Not known: Possibility of acute immuno-allergic interstitial nephritis.

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/