Adverse reactions : תופעות לוואי

4.8.    Undesirable effects
The most commonly reported adverse reaction is diarrhoea (occurring in 1 patient out of 10).
Among the most serious adverse reactions pseudo-membranous colitis and toxic epidermal necrolysis occur in 1 to 10 patients in 10,000. The frequencies for pancytopenia, anaphylactic shock and Stevens-Johnson syndrome cannot be estimated from the currently available data.
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.

Frequency not
Very         Common            Uncommon              Rare
System Organ                                                                         known (cannot be common        (≥ 1/100 to <      (≥ 1/1,000 to <   (≥ 1/10,000 to Class                                                                                 estimated from (≥ 1/10)         1/10)              1/100)          < 1/1,000) available data)
Infections and                 candida infection*                     pseudo- infestations                                                          membranous thrombocytopenia, leukopenia             liti agranulocytosis pancytopenia*,
Blood and anaemia*                                               neutropenia,
lymphatic haemolytic system anaemia*,
disorders thrombocytosis*,
Frequency not
Very         Common          Uncommon               Rare
System Organ                                                                        known (cannot be common        (≥ 1/100 to <    (≥ 1/1,000 to <    (≥ 1/10,000 to Class                                                                                estimated from (≥ 1/10)         1/10)            1/100)           < 1/1,000) available data) anaphylactoid shock*,
Immune system                                                                        anaphylactic disorders                                                                            shock*, anaphylactoid reaction*,
anaphylactic
Metabolism and                                   hypokalaemia nutrition
Psychiatric                    insomnia                                              delirium* disorders
Nervous system                 headache          seizure* disorders hypotension,
Vascular                                         phlebitis,
disorders                                        thrombophlebitis,
flushing epistaxis       eosinophilic
Respiratory,
pneumonia thoracic and mediastinal disorders diarrhoea abdominal pain,                           stomatitis vomiting,
Gastrointestinal           constipation,
disorders                  nausea,
dyspepsia

Hepatobiliary                                                                        hepatitis*, jaundice disorders rash, pruritus    erythema            toxic epidermal Stevens-Johnson multiforme*,        necrolysis      syndrome*,
urticaria, rash                     dermatitis maculopapular*                      exfoliative, drug reaction with eosinophilia and
Skin and                                                                             systemic subcutaneous                                                                         symptoms tissue disorders                                                                     (DRESS)*, acute generalised exanthematous pustulosis
(AGEP)*,
dermatitis bullous,
purpura

Musculoskeletal                                  arthralgia,
and connective                                   myalgia tissue disorders
Renal and                                                                            renal failure, urinary                                                                              tubulointerstitial disorders                                                                            nephritis* Frequency not
Very          Common            Uncommon              Rare
System Organ                                                                           known (cannot be common         (≥ 1/100 to <      (≥ 1/1,000 to <   (≥ 1/10,000 to Class                                                                                   estimated from (≥ 1/10)          1/10)              1/100)          < 1/1,000) available data)
General                         pyrexia,             chills disorders and                   injection-site administration                  reaction site conditions alanine              blood glucose                   bleeding time aminotransferase     decreased,                      prolonged, gamma- increased,           blood bilirubin                 glutamyltransferase aspartate            increased,                      increased aminotransferase     prothrombin time increased, protein   prolonged total decreased,
blood albumin decreased,
Coombs direct test
Investigations positive, blood creatinine increased, blood alkaline phosphatase increased, blood urea increased,
activated partial thromboplastin time prolonged
*ADR identified post marketing
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.
Beta-lactam antibiotic class effects
Beta-lactam antibiotics, including piperacillin tazobactam, may            lead to manifestations   of encephalopathy and convulsions (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 as per local regulations.