Paizu Adverse Reactions

The most commonly reported adverse reaction is diarrhoea (occurring in 1 patient out of 10).
Among the most serious adverse reactions, pseudomembranous 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 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.
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).
Infections and infestations: Common: Candida infection*.
Rare: Pseudo-membranous colitis.
Blood and lymphatic system disorders: Common: Thrombocytopenia, anaemia*
Uncommon: Leukopenia.
Rare: Agranulocytosis.
Not known: Pancytopenia*, neutropenia, haemolytic anaemia*,thrombocytosis*, eosinophilia*.
Immune system disorders: Not known: Anaphylactoid shock*, anaphylactic shock*, anaphylactoid reaction*, anaphylactic reaction*, hypersensitivity*
Metabolism and nutrition disorders: Uncommon: Hypokalaemia.
Psychiatric disorders: Common: Insomnia.
Nervous system disorders: Common: Headache.
Vascular disorders: Uncommon: Hypotension, phlebitis, thrombophlebitis, flushing.
Respiratory, thoracic and mediastinal disorders: Rare: Epistaxis.
Not known: Eosinophilic pneumonia.
Gastrointestinal disorders: Very common: Diarrhoea.
Common: Abdominal pain, vomiting, nausea, constipation, dyspepsia.
Rare: Stomatitis.
Hepatobiliary disorders: Not known: Hepatitis*, jaundice.
Skin and subcutaneous tissue disorders: Common: Rash, pruritus.
Uncommon: Erythema multiforme*, urticaria, rash maculopapular*
Rare: Toxic epidermal necrolysis*
Not known: Stevens-Johnson syndrome*, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms (DRESS)*, acute generalised exanthematous pustulosis (AGEP)*, dermatitis bullous, purpura.
Musculoskeletal and connective tissue disorders: Uncommon: Arthralgia, myalgia.
Renal and urinary disorders: Not known: Renal failure, tubulointerstitial nephritis*.
General disorders and administration site conditions: Common: Pyrexia, injection site reaction.
Uncommon: Chills.
Investigations: Common: Alanine aminotransferase, aspartate aminotransferase increased, protein total decreased, blood albumin decreased, Coombs direct test positive, blood creatinine increased, blood alkaline phosphatase increased, blood urea increased, activated partial thromboplastin time prolonged.
Uncommon: Blood glucose decreased, blood bilirubin increased, prothrombin time prolonged.
Not known: Bleeding time prolonged, gamma-glutamyltransferase increased.
*ADR identified post-marketing;.
Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.