Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The most commonly reported adverse reactions (occurring in 1 to 10 patients in 100) are diarrhoea, vomiting, nausea and rash.

In the following table, adverse reactions are listed by system organ class and MedDRA-preferred term. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
System Organ          Common         Uncommon               Rare               Very rare Class                 1/100 to <      1/1,000 to <       1/10,000 to <        (< 1/10,000) 1/10            1/100              1/1,000
Infections and                     candidal infestations                       superinfection
Blood and                          leukopenia,        anaemia,             agranulocytosis, lymphatic                          neutropenia,       haemolytic           pancytopenia, system                             thrombocytopeni    anaemia,             activated partial disorders                          a                  purpura,             thromboplastin epistaxis,           time prolonged,
bleeding time        prothrombin time prolonged,           prolonged,
eosinophilia         Coombs direct test positive,
thrombocythaemia
Immune system                      hypersensitivity   anaphylactic/ disorders                                             anaphylactoid reaction
(including shock)
Metabolism and                                                             hypokalaemia, nutrition                                                                  blood glucose disorders                                                                  decreased, blood albumin decreased, blood protein total decreased
Nervous system                     headache,
disorders                          insomnia
Vascular                           hypotension,      flushing disorders                          thrombophlebitis,
phlebitis
Gastrointestinal   diarrhoea,      jaundice,          pseudo- disorders          vomiting,       stomatitis,        membranous nausea          constipation,      colitis, abdominal dyspepsia          pain
Hepatobiliary                      alanine            hepatitis, blood disorders                          aminotransferas    bilirubin e increased,       increased, blood aspartate          alkaline aminotransferas    phosphatase e increased        increased,
gamma- glutamyltrans- ferase increased
Skin and         rash, including   urticaria, pruritus erythema            toxic epidermal subcutaneous     maculopapular                         multiforme,         necrolysis, tissue disorders rash                                  dermatitis          Stevens-Johnson bullous,             syndrome exanthema
Musculoskeletal                                        arthralgia, and connective                                         myalgia tissue disorders
Renal and                           blood creatinine   renal failure,       blood urea urinary                             increased          tubulointerstitial   increased disorders                                              nephritis General                             pyrexia,           chills disorders and                       injection-site administration                      reaction site conditions


Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.