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Note: This document contains side effect information about ceftolozane / tazobactam. Some of the dosage forms listed on this page may not apply to the brand name Zerbaxa.
Applies to ceftolozane / tazobactam: intravenous powder for solution, powder iv (infusion)
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:
Incidence not known
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:
Applies to ceftolozane / tazobactam: intravenous powder for injection
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 Clostridium difficile colitis.
In 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 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 clinical studies, hemolysis was not reported in patients who developed a positive direct Coombs test (in any treatment group).
Very common (10% or more): Positive direct Coombs test (up to 31.2%)
Common (1% to 10%): Anemia, thrombocytosis
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
Uncommon (0.1% to 1%): Increased serum GGT
Common (1% to 10%): Renal impairment/renal failure (included acute renal failure, anuria, azotemia, oliguria, prerenal failure, renal failure, renal impairment)
Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, abdominal pain, C difficile colitis (included C difficile colitis, C difficile infection, Clostridium test positive)
Uncommon (0.1% to 1%): Paralytic ileus, gastritis, abdominal distension, dyspepsia, flatulence, oropharyngeal candidiasis
Frequency not reported: C difficile-associated diarrhea
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
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.
Common (1% to 10%): Pyrexia, increased mortality
Uncommon (0.1% to 1%): Increased serum alkaline phosphatase, candidiasis
Common (1 to 10%): Insomnia, anxiety
Common (1% to 10%): Hypokalemia
Uncommon (0.1% to 1%): Hyperglycemia, hypomagnesemia, hypophosphatemia
Common (1% to 10%): Hypotension, atrial fibrillation
Uncommon (0.1% to 1%): Tachycardia, angina pectoris, venous thrombosis, phlebitis
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Urticaria
Common (1% to 10%): Infusion site reactions
Uncommon (0.1% to 1%): Dyspnea
Uncommon (0.1% to 1%): Vulvovaginal candidiasis, fungal urinary tract infection
Frequency not reported: Hypersensitivity reactions