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Ceftolozane / tazobactam Side Effects

For the Consumer

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:

More Common

  • Fever

Less Common

  • Blurred vision
  • confusion
  • convulsions
  • decreased urine
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • pale skin
  • rash
  • sweating
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Rare

  • Abdominal or stomach cramps or pain
  • arm, back, or jaw pain
  • bloating
  • bloody urine
  • chest pain or discomfort
  • chest tightness or heaviness
  • constipation
  • creamy white, curd-like patches in the mouth or throat
  • decreased frequency or amount of urine
  • diarrhea
  • dry, red, hot, or irritated skin
  • fast or irregular heartbeat
  • hives or welts, itching skin
  • increased thirst
  • lower back or side pain
  • pain when eating or swallowing
  • severe constipation
  • severe vomiting
  • swelling of the face, fingers, or lower legs
  • weight gain

Incidence Not Known

  • Abdominal or stomach tenderness
  • cough
  • difficulty with swallowing
  • dizziness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe abdominal or stomach cramps and pain
  • watery and severe diarrhea, which may also be bloody

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:

More Common

Less Common

  • Acid or sour stomach
  • belching
  • burning feeling in the chest or stomach
  • fear or nervousness
  • heartburn
  • indigestion
  • stomach discomfort or upset
  • trouble sleeping

Rare

For Healthcare Professionals

Applies to ceftolozane / tazobactam: intravenous powder for injection

General

The most common side effects were nausea, diarrhea, headache, constipation, and pyrexia.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, constipation, vomiting, abdominal pain

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

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

Nervous system

Common (1% to 10%): Headache, dizziness

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

Other

In phase 2 and 3 complicated intraabdominal 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, increased mortality

Uncommon (0.1% to 1%): Increased serum alkaline phosphatase, candidiasis[Ref]

Psychiatric

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

Metabolic

Common (1% to 10%): Hypokalemia

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

Hepatic

Common (1% to 10%): Increased ALT, increased AST

Uncommon (0.1% to 1%): Increased serum GGT[Ref]

Hematologic

Common (1% to 10%): Anemia, thrombocytosis

Uncommon (0.1% to 1%): Positive Coombs test[Ref]

Cardiovascular

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

Uncommon (0.1% to 1%): Tachycardia, angina pectoris, venous thrombosis, phlebitis[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Urticaria[Ref]

Local

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

Renal

Uncommon (0.1% to 1%): Renal impairment, renal failure[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea[Ref]

Genitourinary

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

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Zerbaxa (ceftolozane-tazobactam)." Cubist Pharmaceuticals Inc, Lexington, MA.

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.

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