Ceftolozane / Tazobactam Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 21, 2024.

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

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to make sure that the medicine is working properly and that the infection is cleared up completely. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Ceftolozane and tazobactam combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

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:

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:

For healthcare professionals

Applies to ceftolozane / tazobactam: intravenous powder for injection.

General adverse events

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

• 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]

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]

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]

See also:

Further information

Ceftolozane/tazobactam side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer