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Zosyn Injection

Last reviewed on RxList: 8/29/2019
Zosyn Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/29/2019

Zosyn (piperacillin/tazobactam) for Injection is an antibiotic used to treat patients with moderate to severe bacterial infections. Zosyn is available in generic form. Common side effects of Zosyn include:

The usual total daily dose of Zosyn for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of Zosyn treatment is from 7 to 10 days. Zosyn may interact with tobramycin, aminoglycosides, probenecid, oral anticoagulants, vecuronium, or methotrexate. Tell your doctor all medications and supplements you use. During pregnancy, Zosyn should be used only if prescribed. Piperacillin passes into breast milk in small amounts; tazobactam concentrations in human milk are unknown. Consult your doctor before breastfeeding.

Our Zosyn (piperacillin/tazobactam) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Zosyn Injection Consumer Information
SIDE EFFECTS: Swelling, redness, pain, and soreness at the injection site may occur. Dizziness, trouble sleeping, nausea, vomiting, diarrhea, and headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle cramps/spasms, swelling of the arms/legs/hands/feet, easy bruising/bleeding, chest pain, confusion, new signs of infection (such as fever, persistent sore throat), severe abdominal/stomach pain, slow/fast/irregular heartbeat, persistent nausea/vomiting, seizures, extreme tiredness, dark/cloudy urine, change in the amount of urine, yellowing eyes/skin.

Serious skin reactions can occur. Tell your doctor right away if you develop rash, peeling, sores or blisters on the skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zosyn Injection (Piperacillin and Tazobactam Pharmacy Bulk Vial)

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Zosyn Injection Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During the initial clinical investigations, 2621 patients worldwide were treated with ZOSYN in phase 3 trials. In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. However, in 3.2% of the patients treated worldwide, ZOSYN was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%).

Table 3: Adverse Reactions from ZOSYN Monotherapy Clinical Trials

System Organ Class
Adverse Reaction
Gastrointestinal disorders
Diarrhea (11.3%)
Constipation (7.7%)
Nausea (6.9%)
Vomiting (3.3%)
Dyspepsia (3.3%)
Abdominal pain (1.3%)
General disorders and administration site conditions
Fever (2.4%)
Injection site reaction ( ≤ 1%)
Rigors ( ≤ 1%)
Immune system disorders
Anaphylaxis ( ≤ 1%)
Infections and infestations
Candidiasis (1.6%)
Pseudomembranous colitis ( ≤ 1%)
Metabolism and nutrition disorders
Hypoglycemia ( ≤ 1%)
Musculoskeletal and connective tissue disorders
Myalgia( ≤ 1%)
Arthralgia ( ≤ 1%)
Nervous system disorders
Headache (7.7%)
Psychiatric disorders
Insomnia (6.6%)
Skin and subcutaneous tissue disorders
Rash (4.2%, including maculopapular, bullous, and urticarial)
Pruritus (3.1%)
Purpura ( ≤ 1%)
Vascular disorders
Phlebitis (1.3%)
Thrombophlebitis ( ≤ 1%)
Hypotension ( ≤ 1%)
Flushing ( ≤ 1%)
Respiratory, thoracic and mediastinal disorders
Epistaxis ( ≤ 1%)

Nosocomial Pneumonia Trials

Two trials of nosocomial lower respiratory tract infections were conducted. In one study, 222 patients were treated with ZOSYN in a dosing regimen of 4.5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with imipenem/cilastatin (500 mg/500 mg q6h) in combination with an aminoglycoside. In this trial, treatment-emergent adverse events were reported by 402 patients, 204 (91.9%) in the piperacillin/tazobactam group and 198 (92.1%) in the imipenem/cilastatin group. Twenty-five (11.0%) patients in the piperacillin/tazobactam group and 14 (6.5%) in the imipenem/cilastatin group (p > 0.05) discontinued treatment due to an adverse event. The second trial used a dosing regimen of 3.375 g given every 4 hours with an aminoglycoside.

Table 4: Adverse Reactions from ZOSYN Plus Aminoglycoside Clinical Trials*

System Organ Class
Adverse Reaction
Blood and lymphatic system disorders
Thrombocythemia (1.4%)
Anemia ( ≤ 1%)
Thrombocytopenia ( ≤ 1%)
Eosinophilia ( ≤ 1%)
Gastrointestinal disorders
Diarrhea (20%)
Constipation (8.4%)
Nausea (5.8%)
Vomiting (2.7%)
Dyspepsia (1.9%)
Abdominal pain (1.8%)
Stomatitis ( ≤ 1%)
General disorders and administration site conditions
Fever (3.2%)
Injection site reaction ( ≤ 1%)
Infections and infestations
Oral candidiasis (3.9%)
Candidiasis (1.8%)
Investigations
BUN increased (1.8%)
Blood creatinine increased (1.8%)
Liver function test abnormal (1.4%)
Alkaline phosphatase increased ( ≤ 1%)
Aspartate aminotransferase increased ( ≤ 1%)
Alanine aminotransferase increased ( ≤ 1%)
Metabolism and nutrition disorders
Hypoglycemia ( ≤ 1%)
Hypokalemia ( ≤ 1%)
Nervous system disorders
Headache (4.5%)
Psychiatric disorders
Insomnia (4.5%)
Renal and urinary disorders
Renal failure ( ≤ 1%)
Skin and subcutaneous tissue disorders
Rash (3.9%)
Pruritus (3.2%)
Vascular disorders
Thrombophlebitis (1.3%)
Hypotension (1.3%)
*For adverse drug reactions that appeared in both studies the higher frequency is presented.

Pediatrics

Studies of ZOSYN in pediatric patients suggest a similar safety profile to that seen in adults. In a prospective, randomized, comparative, open-label clinical trial of pediatric patients with severe intraabdominal infections (including appendicitis and/or peritonitis), 273 patients were treated with ZOSYN (112.5 mg/kg every 8 hours) and 269 patients were treated with cefotaxime (50 mg/kg) plus metronidazole (7.5 mg/kg) every 8 hours. In this trial, treatment-emergent adverse events were reported by 146 patients, 73 (26.7%) in the ZOSYN group and 73 (27.1%) in the cefotaxime/metronidazole group. Six patients (2.2%) in the ZOSYN group and 5 patients (1.9%) in the cefotaxime/metronidazole group discontinued due to an adverse event.

Adverse Laboratory Events (Seen During Clinical Trials)

Of the trials reported, including that of nosocomial lower respiratory tract infections in which a higher dose of ZOSYN was used in combination with an aminoglycoside, changes in laboratory parameters include:

Hematologic - decreases in hemoglobin and hematocrit, thrombocytopenia, increases in platelet count, eosinophilia, leukopenia, neutropenia. These patients were withdrawn from therapy; some had accompanying systemic symptoms (e.g., fever, rigors, chills).

Coagulation - positive direct Coombs' test, prolonged prothrombin time, prolonged partial thromboplastin time

Hepatic - transient elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin

Renal - increases in serum creatinine, blood urea nitrogen

Additional laboratory events include abnormalities in electrolytes (i.e., increases and decreases in sodium, potassium, and calcium), hyperglycemia, decreases in total protein or albumin, blood glucose decreased, gamma-glutamyltransferase increased, hypokalemia, and bleeding time prolonged.

Post-Marketing Experience

In addition to the adverse drug reactions identified in clinical trials in Table 3 and Table 4, the following adverse reactions have been identified during post-approval use of ZOSYN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary - hepatitis, jaundice

Hematologic - hemolytic anemia, agranulocytosis, pancytopenia

Immune - hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock)

Renal - interstitial nephritis

Respiratory - eosinophilic pneumonia

Skin and Appendages - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), dermatitis exfoliative

Additional Experience With piperacillin

The following adverse reaction has also been reported for piperacillin for injection:

Skeletal - prolonged muscle relaxation [see DRUG INTERACTIONS].

Post-marketing experience with ZOSYN in pediatric patients suggests a similar safety profile to that seen in adults.

Read the entire FDA prescribing information for Zosyn Injection (Piperacillin and Tazobactam Pharmacy Bulk Vial)

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© Zosyn Injection Patient Information is supplied by Cerner Multum, Inc. and Zosyn Injection Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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