Piperacillin and tazobactam Side Effects

Please note - some side effects for Piperacillin and tazobactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: intravenous powder for injection; intravenous solution

General

In general, side effects have been described as transient and mild to moderate. In clinical trials, piperacillin-tazobactam was discontinued in 3.2% of patients due to dermatologic effects (including rash and pruritus; 1.3%), gastrointestinal effects (including diarrhea, nausea, and vomiting; 0.9%), and allergic reactions (0.5%). In nosocomial pneumonia trials, 11% of patients discontinued piperacillin-tazobactam due to a side effect.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (up to 20%), constipation (up to 8.4%), nausea (up to 6.9%), oral thrush/moniliasis (up to 3.9%), vomiting (up to 3.3%), dyspepsia (up to 3.3%), hiccough (up to 2.6%), stool changes (up to 2.4%), abdominal pain (up to 1.8%), enlarged abdomen (1.4%), flatulence (up to 1.3%), anorexia (1.3%), and duodenal ulcer (1.3%). Melena, gastrointestinal hemorrhage, gastritis, ileus, taste perversion, ulcerative stomatitis, colitis, dry mouth, dysphagia, glossitis, stomatitis, fecal incontinence, gastric ulcer, pancreatitis, and pseudomembranous colitis have been reported in 1% or fewer patients. Clostridium difficile-associated diarrhea has also been reported.

Diarrhea associated with piperacillin-tazobactam is usually self-limited. There are case reports of pseudomembranous colitis in patients receiving piperacillin-tazobactam. The onset of pseudomembranous colitis symptoms may develop during or after antibacterial therapy.

Nervous system

Piperacillin may have neuromuscular blocking properties, and has been noted to enhance the effect of neuromuscular blocking agents.

Patients with renal insufficiency may be at greater risk of developing seizures, even with adjusted dosages.

Nervous system side effects have included headache (up to 7.7%), insomnia (up to 6.6%), agitation (up to 7.1%), and dizziness (1.4%). Tremor, convulsions, vertigo, syncope, central nervous system depression, grand mal convulsion, cerebrovascular accident, somnolence, tinnitus, hypertonia, stupor, and deafness have been reported in 1% or fewer patients. Tonic-clonic seizure has also been reported. Neurotoxicity has been reported with piperacillin.

Dermatologic

A patient with mononucleosis developed a nonallergic rash after 3 weeks of treatment with piperacillin-tazobactam for osteomyelitis. He had no history of penicillin allergy. His Epstein-Barr virus IgG and IgM antibodies were positive. The rash resolved quickly after discontinuation of the piperacillin-tazobactam.

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

Dermatologic side effects have included rash (including maculopapular, bullous, urticarial, and eczematoid; up to 4.2%), erythematous rash (3.9%), pruritus (up to 3.2%), excoriations (1.4%), sweating (1.4%), and diaphoresis (up to 1.3%). Fungal dermatitis (1% or less), exanthemous pustulosis, and drug-induced petechial rash have been reported. Petechial rash or purpura due to thrombocytopenia, exanthematous pustulosis, bullous dermatosis, erythema nodosum, exanthems, exfoliative dermatitis, urticaria, pruritus, vesiculation, Jarisch-Herxheimer reaction, Stevens-Johnson syndrome, purpura, and vasculitis have been reported with piperacillin. Erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported during postmarketing experience.

Other

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

Other side effects have included fever (up to 3.2%), pain (up to 3.2%), edema (up to 1.9%), generalized edema (1.8%), peripheral edema (1.8%), moniliasis (up to 1.8%), and chest pain (up to 1.3%). Rigors, back pain, malaise, flushing, asthenia, earache, xerosis, and decreased drug level have been reported in 1% or fewer patients. The use of piperacillin-tazobactam has been associated with false-positive tests for Aspergillus galactomannan antigenemia. Candidal superinfections have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included hypertension (up to 1.6%), cardiac arrest (up to 1.3%), supraventricular tachycardia (up to 1.3%), thrombophlebitis (1.3%), and hypotension (up to 1.3%). Tachycardia, ventricular tachycardia, bradycardia, arrhythmia, atrial fibrillation, ventricular fibrillation, cardiac failure, circulatory failure, myocardial infarction, angina, sinus bradycardia, ventricular extrasystoles, and mesenteric embolism have been reported in 1% or fewer patients.

Psychiatric

Psychiatric side effects have included anxiety (up to 3.2%) and confusion (up to 1.3%). Hallucination, aggressive reaction (combative), and depression have been reported in 1% or fewer patients.

Genitourinary

Genitourinary side effects have included urinary tract infection (2.7%) and urinary incontinence (1.3%). Genital pruritus, balanoposthitis, leukorrhea, vaginitis, perineal irritation/pain, urinary retention, dysuria, oliguria, hematuria, urinary incontinence, urinary tract infection with trichomonas, and yeast in urine have been reported in 1% or fewer patients. Proteinuria and pyuria have also been reported.

Metabolic

Metabolic side effects have included fluid overload (1.9%). Symptomatic hypoglycemia, thirst, acidosis, increased alkaline phosphatase, dehydration, gout, vitamin B12 deficiency anemia, hypernatremia, hypokalemia, hyponatremia, hypophosphatemia, hyperglycemia, and hypoglycemia have been reported in 1% or fewer patients. Decreased total protein or albumin, hypomagnesemia, abnormalities in electrolytes (i.e., increased and decreased sodium, potassium, and calcium), decreased blood glucose, and transient elevations of alkaline phosphatase have also been reported. Electrolyte and acid-base disturbances have been reported with piperacillin.

Renal

Renal side effects have included increased serum creatinine and blood urea nitrogen in 1.8% of patients. Acute kidney failure and abnormal kidney function have been reported in 1% or fewer patients. Acute onset of renal dysfunction (with elevated serum creatinine, lumbar pain, rash, fever, arthralgias, and eosinophiluria) has been reported. Interstitial nephritis and renal failure have been reported during postmarketing experience.

A 51-year-old woman developed an acute onset of renal dysfunction after 6 days of therapy with piperacillin-tazobactam. The patient also had an elevated serum creatinine, lumbar pain, rash, fever, arthralgias, and eosinophiluria. The piperacillin-tazobactam was discontinued and the patient's symptoms improved to baseline after 21 days of prednisone.

Hematologic

Hematologic side effects have included thrombocythemia (1.4%). Anemia, thrombocytopenia, eosinophilia, leukopenia, purpura, hypochromic anemia, leukocytosis, decreased prothrombin, and ecchymosis have been reported in 1% or fewer patients. Decreased hemoglobin and hematocrit, increased platelet count, neutropenia, positive direct Coombs' test, prolonged prothrombin time, prolonged partial thromboplastin time, reversible bone marrow suppression, and prolonged bleeding time have been reported. Leukopenia/neutropenia has frequently been associated with prolonged therapy (i.e., 21 days or longer) and appears to be reversible. Bleeding disorders, neutropenia, thrombocytopenia, and hemolytic anemia have been reported with piperacillin. Leukopenia has been reported in 23% of patients with liver disease receiving beta-lactam antibiotics. Hemolytic anemia, anemia, thrombocytosis, agranulocytosis, and pancytopenia have been reported during postmarketing experience.

Reversible bone marrow suppression is rare, and usually limited to prolonged therapy with piperacillin.

Risk factors for increased bleeding time with piperacillin include age over 60 years, cytotoxic chemotherapy, thrombocytopenia, azotemia, doses of 12 grams per day or more, and therapy for 6 days or more.

Hepatic

Hepatic side effects have included abnormal liver function tests (1.4%). Increased SGOT and SGPT have been reported in 1% or fewer patients. Transient elevations of AST (SGOT), ALT (SGPT), and bilirubin and increased gamma-glutamyltransferase have been reported. Hepatotoxicity has been reported with piperacillin. Hepatitis and cholestatic jaundice have been reported during postmarketing experience.

Respiratory

Respiratory side effects have included pleural effusion (1.3%), pneumothorax (1.3%), rhinitis (1.2%), and dyspnea (up to 1.1%). Pharyngitis, pulmonary edema, bronchospasm, coughing, epistaxis, pulmonary embolism, hyperventilation, respiratory disorder, increased cough, atelectasis, hemoptysis, and hypoxia have been reported in 1% or fewer patients.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis (1% or less) and allergic reactions. Hypersensitivity reactions have generally included urticarial rash, but rare reports of severe reactions, including anaphylaxis, Stevens-Johnson syndrome, dyspnea, hypotension, and edema, have been reported. Hypersensitivity reactions, including fever, rash, and eosinophilia, have been reported. Hypersensitivity reactions and anaphylactic/anaphylactoid reactions (resulting in shock and fatalities) have been reported with piperacillin. Hypersensitivity reactions and anaphylactic/anaphylactoid reactions (including shock) have also been reported during postmarketing experience.

Local

Local side effects have included phlebitis (1.3%), inflammation at injection site (up to 1.3%), and thrombophlebitis (0.2%). Injection site edema, injection site pain, injection site reaction, and local reaction to procedure have been reported in 1% or fewer patients.

Musculoskeletal

Musculoskeletal side effects have included myalgia and arthralgia in 1% or fewer patients. Prolonged muscle relaxation has been reported with piperacillin.

Ocular

Ocular side effects have included photophobia, diplopia, and conjunctivitis in 1% or fewer patients.

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