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Azactam Injection

Last reviewed on RxList: 2/23/2017
Azactam Injection Side Effects Center

Last reviewed on RxList 01/06/2017

Azactam (aztreonam) for Injection is an antibiotic used to treat severe infections of the urinary tract, lower respiratory tract, skin, stomach, female reproductive organs, and other body systems. Azactam is available in generic form. Common side effects of Azactam include:

  • stomach discomfort,
  • diarrhea,
  • nausea,
  • vomiting,
  • dizziness,
  • headache,
  • blurred vision,
  • injection site reactions (redness, discomfort, pain, swelling, or irritation),
  • flushing (warmth/redness/tingly feeling under your skin),
  • numbness/tingling/burning pain,
  • skin rash or itching, or
  • vaginal itching or discharge.

Tell your doctor if you have serious side effects of Azactam including:

  • fast or irregular heartbeat,
  • confusion,
  • easy bruising or bleeding,
  • ringing in the ears,
  • seizures,
  • chest pain,
  • yellowing eyes or skin,
  • dark urine,
  • severe stomach or abdominal pain,
  • persistent nausea or vomiting,
  • unusual fatigue, or
  • persistent signs of infection (e.g., fever, sore throat).

Dose of Azactam depends on the severity of the infection being treated. Azactam may interact with amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycinm, or tobramycin. Tell your doctor all medications you use. Azactam should be used only when prescribed during pregnancy. This medication passes into breast milk in small amounts. While there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.

Our Azactam (aztreonam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Azactam Injection Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • confusion, seizure (convulsions);
  • feeling light-headed, fainting;
  • pale skin, easy bruising or bleeding, unusual weakness;
  • fever, chills, body aches, flu symptoms; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild stomach discomfort;
  • warmth, redness, or tingly feeling under your skin;
  • dizziness;
  • numbness, tingling, or burning pain;
  • mild skin rash or itching;
  • vaginal itching or discharge; or
  • pain, swelling, or irritation around the IV needle.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azactam Injection (Aztreonam Injection)

Azactam Injection Professional Information

SIDE EFFECTS

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:

Hypersensitivity-anaphylaxis, angioedema, bronchospasm

Hematologic-pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis

Gastrointestinal-abdominal cramps; rare cases of C. difficile-associated diarrhea, including pseudomembranous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Dermatologic-toxic epidermal necrolysis (see WARNINGS), purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis

Cardiovascular-hypotension, transient ECG changes (ventricular bigeminy and PVC), flushing

Respiratory-wheezing, dyspnea, chest pain

Hepatobiliary-hepatitis, jaundice

Nervous System-seizure, confusion, vertigo, paresthesia, insomnia, dizziness

Musculoskeletal-muscular aches

Special Senses-tinnitus, diplopia, mouth ulcer, altered taste, numb tongue, sneezing, nasal congestion, halitosis

Other-vaginal candidiasis, vaginitis, breast tenderness

Body as a Whole-weakness, 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:

Hepatic-elevations of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of hepatobiliary dysfunction occurred in less than 1% of recipients (see above).

Hematologic-increases in prothrombin and partial thromboplastin times, positive Coombs' test.

Renal-increases in serum creatinine.

Read the entire FDA prescribing information for Azactam Injection (Aztreonam Injection)

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