Piperacillin/Tazobactam Side Effects

Please note - some side effects for Piperacillin/Tazobactam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Piperacillin/Tazobactam - for the Consumer

Piperacillin/Tazobactam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Piperacillin/Tazobactam:

Agitation; constipation; diarrhea; dizziness; headache; indigestion; nausea; pain, swelling, or redness at the injection site; sleeplessness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; decreased urination; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucination; inflammation at the injection site; prolonged muscle relaxation; red, swollen, or blistered skin; seizures; severe diarrhea, vomiting, or stomach pain; shortness of breath; swelling of the hands, ankles, or feet; tremor; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or discharge; vein inflammation or tenderness; yellowing of the eyes or skin.

Side Effects by Body System

General

In general, side effects have been described as transient and mild to moderate. In clinical trials, piperacillin-tazobactam was discontinued 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 post-marketing experience a similar safety profile was reported in pediatric patients that is seen in adults.

Gastrointestinal

Diarrhea associated with piperacillin-tazobactam is usually self-limited. There are case reports of pseudomembranous colitis in patients receiving piperacillin-tazobactam.

Gastrointestinal side effects have included diarrhea (11.3%), constipation (7.7%), nausea (6.9%), vomiting (3.3%), dyspepsia (3.3%), stool changes (2.4%), abdominal pain (1.3%), flatulence (1.3%), anorexia (1.3%), and duodenal ulcer (1.3%). Melena, hemorrhage, gastritis, hiccough, ileus, taste perversion, ulcerative 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.

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.

Dermatologic side effects have included rash (4.2%), including maculopapular, bullous, urticarial, and eczematoid rash, erythematous rash (3.9%), and pruritus (3.1%). Erythema multiforme, exanthemous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have also been reported.

Hypersensitivity

Hypersensitivity reactions generally include urticarial rash, but rare reports of severe reactions, including Stevens-Johnson syndrome, dyspnea, and edema have been reported. There are small studies showing an increased incidence of unexplained fever in patients with cystic fibrosis who are given piperacillin.

Hypersensitivity reactions, including fever, rash, and eosinophilia, occur in approximately 1% to 5% of patients. Severe hypersensitivity reactions to piperacillin-tazobactam are rare, and may include anaphylaxis, edema, hypotension, and dyspnea. Anaphylactic/anaphylactoid reactions resulting in shock and fatalities have been reported with piperacillin.

Local

Local reactions have included injection site reactions (0.5%), pain (0.2%), inflammation (0.2%), phlebitis (1.3%), thrombophlebitis (0.2%), and edema (0,1%).

Cardiovascular

Cardiovascular side effects have included hypertension (1.6%) and edema (1.2%). Tachycardia, supraventricular tachycardia, ventricular tachycardia, bradycardia, arrhythmia, atrial fibrillation, ventricular fibrillation, cardiac arrest, cardiac failure, circulatory failure, myocardial infarction, angina, and flushing have been reported in 1% or fewer patients.

Endocrine

Endocrine side effects have included diaphoresis in 1% or fewer patients.

Genitourinary

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

Hematologic

Hematologic side effects have included thrombophlebitis (1.3%) and decreased hemoglobin and hematocrit, thrombocytopenia, increased platelet count, eosinophilia, leukopenia, neutropenia, positive direct Coombs' test, prolonged prothrombin time, prolonged partial thromboplastin time. Leukopenia/neutropenia has frequently been associated with prolonged therapy (>21 days) and appears to be reversible. Mesenteric embolism, purpura, epistaxis, pulmonary embolism, ecchymosis, hemoptysis, and hemolytic anemia have been reported in 1% or fewer patients. Hemolytic anemia, anemia, thrombocytosis, agranulocytosis, and pancytopenia have also been reported. Leukopenia has been reported in 23% of patients with liver disease receiving beta-lactam antibiotics.

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 transient elevations of alkaline phosphatase, AST (SGOT), ALT (SGPT), and bilirubin, and hepatitis and cholestatic jaundice.

Metabolic

Metabolic side effects have included symptomatic hypoglycemia, thirst, gout, vitamin B12 deficiency anemia, increased and decreased sodium, potassium, calcium, hyperglycemia, decreased total protein or albumin. Hypomagnesemia and hypophosphatemia have also been reported.

Musculoskeletal

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

Nervous system

Nervous system side effects have included headache (7.7%), insomnia (6.6%), agitation (2.1%), dizziness (1.4%), and anxiety (1.2%). Tremor, convulsions, vertigo, syncope, cerebrovascular accident, tinnitus, and combativeness have been reported in 1% or fewer patients. Somnolence, confusion, and tonic-clonic seizure have also been reported.

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.

Ocular

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

Other

Other side effects have included rigors, back pain, malaise, asthenia, chest pain, and candidal superinfections.

Psychiatric

Psychiatric side effects have included confusion, hallucination, and depression in 1% or fewer patients.

Renal

Renal side effects have included increased serum creatinine and blood urea nitrogen. Acute interstitial nephritis and renal failure have also been reported.

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 patients symptoms improved to baseline after 21 days of prednisone.

Respiratory

Respiratory side effects have included rhinitis (1.2%) and dyspnea (1.1%). Pharyngitis, pulmonary edema, bronchospasm, coughing, atelectasis, and hypoxia have been reported in 1% or fewer patients.

Other

The use of piperacillin-tazobactam has been associated with false-positive tests for Aspergillus galactomannan antigenemia.

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