Note: This document contains side effect information about avibactam / ceftazidime. Some dosage forms listed on this page may not apply to the brand name Avycaz.

Applies to avibactam / ceftazidime: intravenous powder for solution.

Serious side effects of Avycaz

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:

More common

• Diarrhea

Less common

• Headache

Rare

• Agitation
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• bluish color
• changes in skin color
• chest pain
• chills
• confusion
• cough
• decreased awareness or responsiveness
• decreased urine
• dizziness
• dry mouth
• fever
• hostility
• increased thirst
• irregular heartbeat
• irritability
• loss of appetite
• loss of consciousness
• mood changes
• muscle pain, cramps, or twitching
• nausea
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• severe sleepiness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, ankles, hands, foot, or leg
• swollen glands
• tenderness
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting
• white patches in the mouth or throat or on the tongue

Incidence not known

• Back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest tightness
• cough
• dark urine
• difficulty breathing
• difficulty swallowing
• fast heartbeat
• general body swelling
• general feeling of tiredness or weakness
• hives, itching, skin rash
• hoarseness
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lower back or side pain
• nosebleeds
• painful or difficult urination
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes red skin lesions, often with a purple center
• unusual weight gain
• yellow eyes or skin

Other side effects of Avycaz

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

• Difficulty having a bowel movement
• stomach pain

Rare

• Anxiety
• change in taste
• loss of taste
• redness of the skin

Incidence not known

• Collection of blood under the skin, deep, dark purple bruise, or itching, pain, or swelling of the skin at the injection site
• dry, red, hot, or irritated skin
• itching of the vagina or genital area
• pain during sexual intercourse
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site
• thick, white vaginal discharge with no odor or with a mild odor

For Healthcare Professionals

Applies to avibactam / ceftazidime: intravenous powder for injection.

General

The most common side effects reported were Coombs direct test positive, nausea, diarrhea, and vomiting.^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension

Uncommon (0.1% to 1%): Tachycardia

Frequency not reported: Atrial fibrillation^[Ref]

Dermatologic

Common (1% to 10%): Maculopapular rash, urticaria, pruritus

Uncommon (0.1% to 1%): Rash

Frequency not reported: Drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)

Ceftazidime:

-Frequency not reported: Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Beta-lactam antibacterial drugs:

-Frequency not reported: Serious skin reactions, severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP)^[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain, constipation, upper abdominal pain, lower abdominal pain

Uncommon (0.1% to 1%): Clostridioides difficile colitis, pseudomembranous colitis

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

Genitourinary

Common (1% to 10%): Urinary tract infection

Ceftazidime:

-Frequency not reported: Vaginal inflammation^[Ref]

Hematologic

DAGT seroconversion in patients using this drug was very common in clinical studies; the estimated range of seroconversion across phase 3 trials was 3.2% to 20.8% in patients with negative Coombs test at baseline and at least 1 follow-up test.

In the phase 3 trials, seroconversion from negative to positive direct Coombs test result among patients with initial negative Coombs test and at least 1 follow-up test was reported in 12.9% (complicated intraabdominal infection [cIAI]), 3% (complicated urinary tract infection [cUTI]), and 21.4% (hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia [HABP/VABP]) of patients using this drug and 3% (cIAI), 0.9% (cUTI), and 7% (HABP/VABP) of patients using a carbapenem comparator. No side effects indicating hemolytic anemia were reported in any treatment group.^[Ref]

Very common (10% or more): Coombs direct test positive, direct antiglobulin test (DAGT or Coombs test) seroconversion, seroconversion from negative to positive direct Coombs test result

Common (1% to 10%): Thrombocytosis, thrombocytopenia, anemia

Uncommon (0.1% to 1%): Leukopenia

Ceftazidime:

-Common (1% to 10%): Eosinophilia

-Uncommon (0.1% to 1%): Neutropenia, lymphocytosis

-Frequency not reported: Agranulocytosis, hemolytic anemia, prolonged prothrombin time^[Ref]

Hepatic

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

Ceftazidime:

-Frequency not reported: Jaundice^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic reaction

Beta-lactam antibacterial drugs:

-Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions^[Ref]

Local

Common (1% to 10%): Infusion site thrombosis, infusion site phlebitis

Frequency not reported: Injection site phlebitis

Ceftazidime:

-Frequency not reported: Infusion site inflammation, injection site hematoma, injection site thrombosis^[Ref]

Metabolic

Common (1% to 10%): Hypokalemia^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back pain

Nervous system

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

Uncommon (0.1% to 1%): Dysgeusia

Ceftazidime:

-Uncommon (0.1% to 1%): Paresthesia

-Frequency not reported: Seizures/convulsion, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, myoclonus/myoclonia, neurological sequelae, tremor^[Ref]

Seizures, nonconvulsive status epilepticus, encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported in patients treated with ceftazidime, especially in those with renal dysfunction. Neurological sequelae (including tremor, myoclonus, nonconvulsive status epilepticus, convulsion, encephalopathy, coma) were occasionally reported with ceftazidime when the dose was not reduced in patients with renal dysfunction.^[Ref]

Other

In a phase 3 cIAI trial, death occurred in 13 of 529 patients using this drug plus metronidazole and 8 of 529 patients using meropenem. In a subgroup of patients with baseline CrCl 30 to 50 mL/min, death occurred in 8 of 41 patients using this drug plus metronidazole and 3 of 43 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 485 patients using this drug plus metronidazole and 5 of 484 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.

In 2 studies in patients with cIAI, the most common diagnosis (about 42%) was appendiceal perforation or peri-appendiceal abscess. About 87% of patients had APACHE II scores up to 10 and 4% had bacteremia at baseline. Death occurred in 18 of 857 patients who used this drug plus metronidazole and in 12 of 863 patients who used meropenem. In a subgroup with baseline CrCl 30 to 50 mL/min, death occurred in 9 of 54 patients who used this drug plus metronidazole and 4 of 59 patients who used meropenem; these patients used a lower dose of this drug than is currently recommended for patients with CrCl 30 to 50 mL/min.

In the phase 3 HABP/VABP trial, death occurred in 42 of 436 patients using this drug and 36 of 434 patients using meropenem.^[Ref]

Common (1% to 10%): Increased blood alkaline phosphatase, pyrexia, candidiasis (including vulvovaginal and oral), death/increased mortality, peripheral edema

Uncommon (0.1% to 1%): Asthenia

Frequency not reported: Decreased clinical response, accidental overdose

Ceftazidime:

-Common (1% to 10%): Increased blood lactate dehydrogenase^[Ref]

Psychiatric

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

Renal

Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, acute kidney injury

Frequency not reported: Renal impairment, nephrolithiasis

Ceftazidime:

-Very rare (less than 0.01%): Tubulointerstitial nephritis^[Ref]

Respiratory

Common (1% to 10%): Pneumonia, cough

Uncommon (0.1% to 1%): Pleural effusion, dyspnea