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Avibactam / ceftazidime Side Effects

For the Consumer

Applies to avibactam / ceftazidime: intravenous powder for solution

Along with its needed effects, avibactam / ceftazidime 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 avibactam / ceftazidime:

Less common or rare
  • Agitation
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • bluish color changes in skin color
  • chest pain
  • chills
  • coma
  • confusion
  • convulsions
  • cough
  • decreased urine
  • dizziness
  • fever
  • headache
  • hostility
  • increased thirst
  • irregular heartbeat
  • lethargy
  • loss of appetite
  • muscle pain or cramps
  • muscle twitching
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pinpoint red spots on the skin
  • rapid weight gain
  • seizures
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, hands, foot, or leg
  • swollen glands
  • tenderness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Incidence not known
  • Difficulty swallowing
  • fast heartbeat
  • hives, itching, or skin rash
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest

Some side effects of avibactam / ceftazidime 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
  • Abdominal or stomach pain
  • diarrhea
  • difficulty having a bowel movement (stool)
Less common or rare
  • Change in taste
  • loss of taste
  • redness of the skin
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash

For Healthcare Professionals

Applies to avibactam / ceftazidime: intravenous powder for injection

General

The most common side effects reported in the phase 2 complicated intraabdominal infection (cIAI) trial were vomiting and nausea. Serious side effects were reported in 9 of 101 patients using this drug with metronidazole compared with 11 of 102 patients using meropenem. The most common side effects leading to discontinuation of this drug were skin and subcutaneous tissue disorders. In a phase 3 cIAI trial, death occurred in 13 of 529 patients using this drug with metronidazole compared with 8 of 529 patients using meropenem.

The most common side effects reported in the phase 2 complicated urinary tract infection trial were constipation and anxiety. Serious side effects were reported in 6 of 68 patients using this drug compared with 2 of 67 patients using imipenem-cilastatin. This drug was discontinued prematurely in 1 patient due to accidental overdose and 1 patient due to atrial fibrillation.[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (up to 14%)
Common (1% to 10%): Nausea, constipation, abdominal pain, upper abdominal pain
Frequency not reported: Clostridium difficile-associated diarrhea[Ref]

Other

In a phase 3 cIAI trial, death occurred in 2.5% of patients using this drug with metronidazole and 1.5% of patients using meropenem. In a subgroup of patients with baseline CrCl 30 to 50 mL/min, death occurred in 8 of 31 patients using this drug with metronidazole and 3 of 35 patients using meropenem; patients using this drug received a 33% lower daily dose than is currently recommended for this patient population. In patients with baseline CrCl greater than 50 mL/min, death occurred in 5 of 498 patients using this drug with metronidazole and 5 of 494 patients using meropenem. Cause of death varied; contributing factors included progression of underlying infection, baseline pathogens isolated that were unlikely to respond to study drug, and delayed surgical intervention.[Ref]

Common (1% to 10%): Seroconversion from negative to positive direct Coombs test result, death
Frequency not reported: Decreased clinical response, accidental overdose

Ceftazidime:
-Frequency not reported: Candidiasis[Ref]

Psychiatric

Common (1% to 10%): Anxiety[Ref]

Metabolic

Common (1% to 10%): Increased blood alkaline phosphatase
Frequency not reported: Hypokalemia

Ceftazidime:
-Frequency not reported: Increased blood lactate dehydrogenase[Ref]

Hepatic

Common (1% to 10%): Increased blood ALT
Frequency not reported: Increased GGT

Ceftazidime:
-Frequency not reported: Jaundice[Ref]

Nervous system

Common (1% to 10%): Dizziness

Ceftazidime:
-Frequency not reported: Dysgeusia, paresthesia, seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonia[Ref]

Renal

Frequency not reported: Acute renal failure, renal impairment

Ceftazidime:
-Frequency not reported: Tubulointerstitial nephritis[Ref]

Dermatologic

Frequency not reported: Rash, skin and subcutaneous tissue disorders

Beta-lactam antibacterial drugs:
-Frequency not reported: Serious skin reactions

Ceftazidime:
-Frequency not reported: Angioedema, erythema multiforme, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria[Ref]

Hematologic

Frequency not reported: Eosinophilia, thrombocytopenia, prolonged prothrombin time

Ceftazidime:
-Frequency not reported: Agranulocytosis, hemolytic anemia, leukopenia, lymphocytosis, neutropenia, thrombocytosis[Ref]

Cardiovascular

Frequency not reported: Atrial fibrillation[Ref]

Hypersensitivity

Beta-lactam antibacterial drugs:
-Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions[Ref]

Local

Ceftazidime:
-Frequency not reported: Infusion-site inflammation, injection-site hematoma, injections-site phlebitis, injection-site thrombosis[Ref]

Genitourinary

Ceftazidime:
-Frequency not reported: Vaginal inflammation[Ref]

References

1. "Product Information. Avycaz (avibactam-cefTAZidime)." Forest Pharmaceuticals, St. Louis, MO.

Some side effects of avibactam / ceftazidime may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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