Tazovex Side Effects

Piperacillin and tazobactam for injection is generally well tolerated. The overall incidence of adverse events was 15.7% although a cause/effect relationship was not established in all cases. This incidence was comparable to that observed with other agents used in the clinical studies. Treatment had to be discontinued in only 2.9% of cases due to adverse reactions.
The most frequently reported adverse clinical reactions were diarrhea, rash, erythema, pruritus, vomiting, allergic reactions, nausea, urticaria, superinfection, phlebitis, thrombophlebitis, dyspepsia and insomnia.
Additional adverse clinical reactions reported as possibly, probably or definitely drug related occurring in less than 0.1% or patients are listed within each body system in order of decreasing severity.
Skin and appendages: Skin reactions, eruption (including bullous dermatitis), increased sweating, erythema multiforme, eczema, exanthema, maculopapular rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Gastrointestinal: Soft/loose stools, stomatitis, constipation, bloody diarrhea, abdominal pain, very rarely pseudomembranous colitis has been reported with piperacillin.
Central nervous system: Muscular weakness, hallucination, headache, fatigue, insomnia.
Autonomic nervous system: Dry mouth.
Musculoskeletal system: Muscle pain, prolonged muscle relaxation, arthralgia.
Vascular system: Superficial phlebitis, hypotension, thrombophlebitis and flushing.
Body as a whole: Fever, hot flushes, edema, tiredness, rigors.
Local reactions: Injection site inflammation, injection site pain.
Hematological changes: Transient reduction in the white blood cell count (leucopenia), neutropenia, thrombocytopenia eosinophilia, disturbed thrombocyte function, positive Coombs' test, rarely hemorrhagic manifestation (including purpura, epistaxis and bleeding time prolonged). Anemia, hemolytic anemia, agranulocytosis, pancytopenia, prolonged partial thromboplastin time prolonged and thrombocytosis.
Hepatic: Transient rise in the serum levels of liver enzymes (ALT, AST, GGT, alkaline phosphatase), bilirubin. The incidence of such rises is higher than with piperacillin alone. Rarely cholestatic jaundice or hepatitis may occur.
Renal: Increased levels of renal function parameters in serum (urea, creatinine) may occur infrequently. Rarely, interstitial nephritis or renal failure may occur.
Hypokalaemia: This was reported rarely in patients with liver disease and those receiving cytotoxic therapy or diuretics when given high doses of piperacillin.
Superinfection: Superinfection, including candidiasis may occur especially with prolonged treatment.
Immune system disorders: Hypersensitivity reaction, anaphylactic/anaphylactoid reaction (including shock).
Metabolism and nutrition disorders: Very rarely decreases in blood albumin, blood total protein have been observed. Piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.