Aztreonam adverse reactions

# Adverse Reactions
Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular administration occurred at rates of approximately 1.9% and 2.4%, respectively.
Systemic reactions (considered to be related to therapy or of uncertain etiology) occurring at an incidence of 1% to 1.3% include diarrhea, nausea and/or vomiting, and rash. Reactions occurring at an incidence of less than 1% are listed within each body system in order of decreasing severity:
- Hypersensitivityanaphylaxis, angioedema, bronchospasm
- Hematologicpancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis
- Gastrointestinalabdominal cramps; rare cases of C. difficileassociated diarrhea, including pseudomembranous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See Warnings.)
- Dermatologictoxic epidermal necrolysis (see Warnings), purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis
- Cardiovascularhypotension, transient ECG changes (ventricular bigeminy and PVC), flushing
- Respiratorywheezing, dyspnea, chest pain
- Hepatobiliaryhepatitis, jaundice
- Nervous Systemseizure, confusion, vertigo, paresthesia, insomnia, dizziness
- Musculoskeletalmuscular aches
- Special Sensestinnitus, diplopia, mouth ulcer, altered taste, numb tongue, sneezing, nasal congestion, halitosis
- Othervaginal candidiasis, vaginitis, breast tenderness
- Body as a Wholeweakness, headache, fever, malaise

## Pediatric Adverse Reactions
Of the 612 pediatric patients who were treated with AZACTAM in clinical trials, less than 1% required discontinuation of therapy due to adverse events. The following systemic adverse events, regardless of drug relationship, occurred in at least 1% of treated patients in domestic clinical trials: rash (4.3%), diarrhea (1.4%), and fever (1.0%). These adverse events were comparable to those observed in adult clinical trials.
In 343 pediatric patients receiving intravenous therapy, the following local reactions were noted: pain (12%), erythema (2.9%), induration (0.9%), and phlebitis (2.1%). In the US patient population, pain occurred in 1.5% of patients, while each of the remaining 3 local reactions had an incidence of 0.5%.
The following laboratory adverse events, regardless of drug relationship, occurred in at least 1% of treated patients: increased eosinophils (6.3%), increased platelets (3.6%), neutropenia (3.2%), increased AST (3.8%), increased ALT (6.5%), and increased serum creatinine (5.8%).
In US pediatric clinical trials, neutropenia (absolute neutrophil count less than 1000/mm3) occurred in 11.3% of patients (8/71) younger than 2 years receiving 30 mg/kg every 6 hours. AST and ALT elevations to greater than 3 times the upper limit of normal were noted in 15% to 20% of patients aged 2 years or above receiving 50 mg/kg every 6 hours. The increased frequency of these reported laboratory adverse events may be due to either increased severity of illness treated or higher doses of AZACTAM administered.

## Adverse Laboratory Changes
Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:
Hepaticelevations of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of hepatobiliary dysfunction occurred in less than 1% of recipients (see above).
Hematologicincreases in prothrombin and partial thromboplastin times, positive Coombs test.
Renalincreases in serum creatinine.