Avibactam / Aztreonam Side Effects

Applies to avibactam / aztreonam: intravenous powder for injection.

General adverse events

The most common adverse drug reactions in patients treated with this drug were anemia, diarrhea, hepatic adverse reactions (including increased ALT and increased AST), hypokalemia, and pyrexia.^[Ref]

Cardiovascular

• Common (1% to 10%): Phlebitis, thrombophlebitis
• Uncommon (0.1% to 1%): Extrasystoles, hypotension, flushing

Aztreonam:

• Frequency not reported: Transient ECG changes

Other beta-lactam antibiotics:

• Frequency not reported: Kounis syndrome

Transient ECG changes included ventricular bigeminy and premature ventricular contraction.

Dermatologic

• Common (1% to 10%): Rash
• Uncommon (0.1% to 1%): Angioedema, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, purpura, urticaria, petechiae, pruritus, hyperhidrosis
• Frequency not reported: Dermatitis, erythema

Aztreonam:

• Frequency not reported: Toxic epidermal necrolysis, angioedema, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis

Rash included rash and macular rash.

Dermatitis included allergic dermatitis and dermatitis.

Gastrointestinal

• Common (1% to 10%): Diarrhea, nausea, vomiting, abdominal pain
• Uncommon (0.1% to 1%): Clostridioides difficile colitis, gastrointestinal hemorrhage, mouth ulceration, oral hypoesthesia
• Rare (0.01% to 0.1%): Pseudomembranous colitis, breath odor
• Frequency not reported: C difficile-associated diarrhea, constipation

Aztreonam:

• Frequency not reported: Numb tongue, halitosis

Abdominal pain included abdominal pain, upper abdominal pain, and lower abdominal pain.

Genitourinary

• Rare (0.01% to 0.1%): Vulvovaginal candidiasis, vaginal infection

Aztreonam:

• Frequency not reported: Vaginal candidiasis, vaginitis

Hematologic

• Common (1% to 10%): Anemia, thrombocytosis, thrombocytopenia
• Uncommon (0.1% to 1%): Increased eosinophil count, leukocytosis, hemorrhage
• Rare (0.01% to 0.1%): Pancytopenia, neutropenia, prolonged prothrombin time, prolonged activated partial thromboplastin time, positive Coombs test, positive direct Coombs test, positive indirect Coombs test
• Frequency not reported: Coagulopathy, eosinophilia

Aztreonam:

• Frequency not reported: Pancytopenia, neutropenia, positive Coombs test

Anemia included anemia and decreased hemoglobin.

Leukocytosis included increased WBC count and leukocytosis.

Thrombocytopenia included thrombocytopenia and decreased platelet count.

Thrombocytosis included thrombocytosis and increased platelet count.

Hepatic

• Very common (10% or more): Hepatic adverse reactions (up to 14.5%)
• Common (1% to 10%): Increased AST, increased ALT, increased transaminases
• Uncommon (0.1% to 1%): Increased GGT
• Rare (0.01% to 0.1%): Hepatitis, jaundice

Aztreonam:

• Frequency not reported: Hepatitis, jaundice

Hepatic adverse reactions included increased ALT, increased AST, abnormal hepatic function, hypertransaminasemia, increased transaminases, increased hepatic enzyme, and liver injury.

Hypersensitivity

• Uncommon (0.1% to 1%): Anaphylactic reaction, drug hypersensitivity
• Frequency not reported: Hypersensitivity reactions

Aztreonam:

• Frequency not reported: Anaphylaxis

Hypersensitivity reactions included rash, flushing, and bronchospasm.

Local

• Common (1% to 10%): Infusion site extravasation, injection site pain

Metabolic

• Common (1% to 10%): Hypokalemia

Musculoskeletal

• Rare (0.01% to 0.1%): Myalgia

Aztreonam:

• Frequency not reported: Muscular aches

Nervous system

• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Encephalopathy, headache, dysgeusia
• Rare (0.01% to 0.1%): Seizure, paresthesia, vertigo, tinnitus
• Frequency not reported: Ageusia

Aztreonam:

• Frequency not reported: Seizure, encephalopathy, vertigo, paresthesia, tinnitus

Ocular

• Rare (0.01% to 0.1%): Diplopia

Aztreonam:

• Frequency not reported: Diplopia

Other

• Common (1% to 10%): Pyrexia
• Uncommon (0.1% to 1%): Chest discomfort, asthenia, increased blood alkaline phosphatase
• Rare (0.01% to 0.1%): Malaise, breast tenderness
• Frequency not reported: Superinfection, C difficile infection

Aztreonam:

• Frequency not reported: Chest pain, breast tenderness, malaise

Pyrexia included pyrexia, hyperpyrexia, hyperthermia, and increased body temperature.

C difficile infection included C difficile infection and C difficile colitis.

Psychiatric

• Common (1% to 10%): Confusional state
• Uncommon (0.1% to 1%): Insomnia
• Frequency not reported: Mental status change, sleep disorder

Mental status change included mental status changes, delirium, confusional state, and disorientation.

Sleep disorder included sleep disorder and insomnia.

Renal

• Uncommon (0.1% to 1%): Increased blood creatinine

Aztreonam:

• Frequency not reported: Increased serum creatinine

Respiratory

• Uncommon (0.1% to 1%): Bronchospasm
• Rare (0.01% to 0.1%): Dyspnea, wheezing, sneezing, nasal congestion

Aztreonam:

• Frequency not reported: Wheezing, dyspnea, sneezing, nasal congestion

See also:

Further information

Avibactam/aztreonam 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