Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Undesirable effects are listed by frequency as follows: 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).

The most commonly reported adverse reactions are diarrhoea, nausea, vomiting, and rash, each having a frequency of 1% but 10%.
Body System                  Frequency           Adverse Reaction 
Infections and               Uncommon            Candidal superinfection infestations


Blood and lymphatic          Uncommon            Leucopenia, neutropenia, system disorders                                 thrombocytopenia 
Rare                Anaemia, haemolytic anaemia, purpura,
epistaxis, bleeding time prolonged,
eosinophilia

Very rare   Agranulocytosis, Coombs' direct test positive, pancytopenia, activated partial thromboplastin time prolonged,
prothrombin time prolonged,
thrombocythaemia
Immune system             Uncommon    Hypersensitivity reaction disorders
Rare        Anaphylactic/anaphylactoid reaction
(including shock)
Metabolism and            Very rare   Hypoalbuminaemia, hypoglycaemia, nutritional disorders                 hypoproteinaemia, hypokalaemia Nervous system            Uncommon    Headache, insomnia disorders

Vascular disorders        Uncommon    Hypotension, phlebitis, thrombophlebitis 
Rare        Flushing

Gastrointestinal          Common      Diarrhoea, nausea, vomiting disorders

Uncommon    Constipation, dyspepsia, jaundice,
stomatitis

Rare        Abdominal pain, pseudomembranous colitis, dry mouth
Hepatobiliary disorders   Uncommon    Alanine aminotransferase increased, aspartate aminotransferase increased

Rare        Blood bilirubin increased, blood alkaline phosphatase increased, gamma glutamyltransferase increased, hepatitis
Skin and subcutaneous     Common      Rash including maculopapular rash tissue disorders
Uncommon    Pruritus, urticaria

Rare        Bullous dermatitis, erythema multiforme,
exanthema

Very rare   Stevens-Johnson Syndrome, toxic epidermal necrolysis
Musculoskeletal,          Rare        Arthralgia, myalgia connective tissue and bone disorders
Renal and urinary         Uncommon    Blood creatinine increased disorders
Rare        Tublointerstitial nephritis, renal failure

Very rare   Blood urea increased
General disorders and        Uncommon           Pyrexia, injection site reaction administration site conditions                   Rare               Chills


The administration of high doses of beta-lactams, particularly in patients with renal insufficiency, can lead to encephalopathies (consciousness fluctuation, myoclonus and convulsions).
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.


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