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Ceftolozane / tazobactam Side Effects

Medically reviewed by Drugs.com. Last updated on May 19, 2023.

Applies to ceftolozane / tazobactam: intravenous powder for solution, powder iv (infusion).

Serious side effects

Along with its needed effects, ceftolozane / tazobactam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ceftolozane / tazobactam:

More common

Less common

Rare

Other side effects

Some side effects of ceftolozane / tazobactam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Rare

For Healthcare Professionals

Applies to ceftolozane / tazobactam: intravenous powder for injection.

General

In clinical studies of complicated intraabdominal infections (cIAI) and complicated urinary tract infections (cUTI), the most common side effects were nausea, diarrhea, headache, constipation, and pyrexia.

In a clinical study for hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP), side effects reported in at least 2% of patients included increased hepatic transaminase, renal impairment/renal failure, diarrhea, intracranial hemorrhage, vomiting, and Clostridioides difficile colitis; the most common side effects were diarrhea, increased ALT, and increased AST.[Ref]

Cardiovascular

Common (1% to 10%): Hypotension, atrial fibrillation

Uncommon (0.1% to 1%): Tachycardia, angina pectoris, venous thrombosis, phlebitis (included superficial phlebitis)

Frequency not reported: Hypertension[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Urticaria

Beta-lactam antibiotics:

-Frequency not reported: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms [DRESS], acute generalized exanthematous pustulosis)[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, abdominal pain (included upper abdominal pain), C difficile colitis (included C difficile colitis, C difficile infection, Clostridioides test positive)

Uncommon (0.1% to 1%): Paralytic ileus, gastritis, abdominal distension, dyspepsia, flatulence, oropharyngeal candidiasis

Frequency not reported: C difficile-associated diarrhea[Ref]

Genitourinary

Uncommon (0.1% to 1%): Vulvovaginal candidiasis, fungal urinary tract infection

Hematologic

Very common (10% or more): Positive direct Coombs test (up to 31.2%)

Common (1% to 10%): Anemia, thrombocytosis (included increased platelet count)

Frequency not reported: Leukopenia (included neutropenia, decreased neutrophil count)[Ref]

In the adult cIAI and cUTI clinical studies, seroconversion to positive direct Coombs test was reported in 0.2% of patients using this drug (0% in patients using the comparator). In the adult HABP/VABP clinical study, seroconversion to positive direct Coombs test was reported in 31.2% of patients using this drug (3.6% in patients using meropenem). In the pediatric cIAI clinical study, seroconversion to positive direct Coombs test was reported in 45.3% of patients using this drug (33.3% in patients using meropenem); in the pediatric cUTI clinical study, seroconversion to positive direct Coombs test was reported in 29.7% of patients using this drug (8.7% in patients using meropenem). In clinical studies, hemolysis was not reported in patients who developed a positive direct Coombs test (in any treatment group).[Ref]

Hepatic

Very common (10% or more): Increased hepatic transaminase (up to 11.9%; included increased ALT, increased AST, increased hepatic enzyme, hypertransaminasemia, abnormal liver function test)

Common (1% to 10%): Increased ALT, increased AST, increased transaminases, abnormal liver function test, increased serum GGT[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Local

Common (1% to 10%): Infusion site reactions[Ref]

Metabolic

Common (1% to 10%): Hypokalemia (included decreased blood potassium)

Uncommon (0.1% to 1%): Hyperglycemia, hypomagnesemia, hypophosphatemia[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, intracranial hemorrhage (included cerebellar hemorrhage, cerebral hematoma, cerebral hemorrhage, intracranial hemorrhage, hemorrhagic stroke, hemorrhagic transformation stroke intraventricular hemorrhage, subarachnoid hemorrhage, subdural hematoma)

Uncommon (0.1% to 1%): Ischemic stroke[Ref]

Other

In phase 2 and 3 cIAI trials, death occurred in 14 of 564 patients using this drug and 8 of 536 patients using meropenem; causes of death varied and included worsening and/or complications of infection, surgery, and underlying conditions.[Ref]

Common (1% to 10%): Pyrexia (included hyperthermia), increased mortality, increased serum alkaline phosphatase

Uncommon (0.1% to 1%): Candidiasis, C difficile infection, Clostridioides test positive[Ref]

Psychiatric

Common (1 to 10%): Insomnia, anxiety[Ref]

Renal

Common (1% to 10%): Renal impairment/renal failure (included acute renal failure, anuria, azotemia, oliguria, prerenal failure, renal failure, renal impairment)[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea

Frequency not reported: Bradypnea (included decreased respiratory rate)[Ref]

References

1. Product Information. Zerbaxa (ceftolozane-tazobactam). Merck Sharp & Dohme (Australia) Pty Ltd. 2020;CCDS-MK7625A-IV-1120.

2. Product Information. Zerbaxa (ceftolozane-tazobactam). Merck Sharp & Dohme (UK) Ltd. 2021.

3. Product Information. Zerbaxa (ceftolozane-tazobactam). Merck Sharp & Dohme LLC. 2022;SUPPL-12.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.