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What the label lists and what reports show

Avibactam and ceftazidime side effects

Avibactam and ceftazidime's FDA label: “The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting.” FAERS holds 163 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug resistance (12 reports).

  • No generic listed

Check it at the source: the avibactam and ceftazidime FDA label on DailyMed (effective April 30, 2025, Allergan, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting.

Table 11. Incidence of Selected Adverse Reactions Occurring in 1% or more of Adult…

Adverse ReactionsAVYCAZ plus metronidazole a (N=529)Meropenem b (N=529)
Headache3%2%
Dizziness2%1%
Diarrhea8%3%
Nausea7%5%
Vomiting5%2%
Abdominal Pain1%1%

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [ see Warnings and Precautions ( 5.2 ) ] Clostridi oid e s difficile -Associated Diarrhea [ see Warnings and Precautions ( 5.3 ) ] Central Nervous System Reactions [ see Warnings and Precautions ( 5.4 ) ] Adult Patients: The most common adverse reactions in cIAI (≥ 5%, when used with metronidazole) patients are diarrhea, nausea and vomiting. The most common adverse reactions (3%) in cUTI patients are diarrhea and nausea. The most common adverse reactions (≥ 5%) in HABP/VABP patients were diarrhea and vomiting. ( 6.1 ) Pediatric Patients (aged 3 months to less than 18 years): The most common adverse reactions (≥ 3%) in pediatric patients aged 3 months and older were vomiting, diarrhea, rash, and infusion site phlebitis. ( 6.1 ) Pediatric Patients (less than 3 months of age): The most common adverse reactions (>3 %) in pediatric patients less than 3 months of age were vomiting and increased transaminases. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, NDA206494 (Abbvie), as published by Allergan, Inc., effective April 30, 2025 (SPL set d9c2803f-dc9c-4b19-b4a3-8303bc8c15fd), via openFDA; the full label on DailyMed

What do FAERS reports show?

163 reports list avibactam and ceftazidime among the medicines taken, each a report of something that happened, not proof the medicine caused it; 16 are coded as a death and 33 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Off Label Use (a use or a product term, not a reaction)34
  • Drug Resistance12
  • Product Storage Error11
  • Respiratory Failure9
  • Acute Kidney Injury (named in the label)8
  • Hypotension7
  • Mental Status Changes7
  • Pyrexia7
  • Death (an outcome recorded in the report)6
  • Dyspnoea6
  • Headache (named in the label)6
  • Nausea (named in the label)6
  • Drug Ineffective (a use or a product term, not a reaction)5
  • Pneumonia (a use or a product term, not a reaction)5
  • Abdominal Pain (named in the label)4
  • Encephalopathy (named in the label)4
  • Fatigue4
  • Pain4
  • Seizure (named in the label)4
  • Septic Shock4
  • Chest Discomfort3
  • Circumstance Or Information Capable Of Leading To Medication Error (a use or a product term, not a reaction)3
  • Confusional State3
  • Diarrhoea (named in the label)3
  • Dizziness (named in the label)3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Avibactam and ceftazidime: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions