Aztreonam Side Effects

Some side effects of aztreonam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to aztreonam: inhalation powder for reconstitution

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

Call your doctor at once if you have a serious side effect such as:

• bronchospasm (wheezing, chest tightness, trouble breathing) right after using the medicine; or

• any new or worsening symptoms.

Less serious side effects of aztreonam may include:

• mild stomach discomfort, vomiting;

• cough, sore throat;

• stuffy nose; or

• low fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to aztreonam: inhalation powder for reconstitution, injectable powder for injection, intravenous solution

General

Aztreonam for injection was generally well tolerated. The overall incidence of systemic side effects was about 1% to 1.3%.

Respiratory

Aztreonam for inhalation:
Very common (10% or more): Cough (54%), nasal congestion (16%), wheezing (16%)
Common (1% to 10%): Bronchospasm (3%)
Postmarketing reports: Dyspnea

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Wheezing, dyspnea, chest pain, sneezing, nasal congestion

Other

Superinfection has been reported in up to 10% of patients during aztreonam therapy and was usually due to enterococcus or staphylococcus.

Aztreonam for inhalation:
Very common (10% or more): Pyrexia (13%), pharyngolaryngeal pain (12%)
Common (1% to 10%): Chest discomfort (8%), abdominal pain (7%)

Aztreonam for injection:
Common (1% to 10%): Superinfection (up to 10%)
Uncommon (0.1% to 1%): Less than 1%: Weakness, fever, malaise, flushing

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Aztreonam for inhalation:
Common (1% to 10%): Vomiting (6%)

Aztreonam for injection:
Common (1% to 10%): 1% to 1.3%: Nausea, vomiting, diarrhea
Uncommon (0.1% to 1%): Less than 1%: Abdominal cramps, mouth ulcer, altered taste, numb tongue, halitosis
Rare (less than 0.1%): Clostridium difficile associated diarrhea, pseudomembranous colitis, gastrointestinal bleeding

Dermatologic

Aztreonam for inhalation:
Common (1% to 10%): Rash (2%)

Aztreonam for injection:
Common (1% to 10%): Rash (1% to 1.3%)
Uncommon (0.1% to 1%): Less than 1%: Toxic epidermal necrolysis, purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis

Toxic epidermal necrolysis associated with aztreonam has been reported in very ill patients on many other medications, making implication of aztreonam difficult.

Local

Aztreonam for injection:
Common (1% to 10%): Discomfort/swelling at the injection site after intramuscular administration (2.4%), phlebitis/thrombophlebitis after intravenous administration (1.9%)

Hypersensitivity

Aztreonam for inhalation:
Frequency not reported: Allergic reaction (with facial rash, facial swelling, throat tightness)

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Anaphylaxis, angioedema, bronchospasm
Rare (less than 0.1%): Maculopapular eruption (at least 1 case)

A 57-year-old male developed a widespread maculopapular eruption two hours after receiving aztreonam. Corticosteroids and antihistamines were needed to control the reaction which disappeared after 8 days. The patient also showed cross-reactivity to ceftazidime which shares the same side chain as aztreonam.

Hematologic

A case of myelosuppression associated with aztreonam has been reported, but because many other drugs were administered and because the patient was bacteremic, implication of aztreonam as the causative agent was difficult.

In vitro studies have shown that aztreonam may inhibit ADP-induced platelet aggregation at high concentrations. Clinically, therapeutic doses of aztreonam have not been associated with bleeding problems.

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Pancytopenia, neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosis
Frequency not reported: Increased prothrombin time, increased partial thromboplastin time, positive Coombs' test

Hepatic

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Hepatitis, jaundice, signs or symptoms of hepatobiliary dysfunction
Frequency not reported: Elevated AST, elevated ALT, elevated alkaline phosphatase

Cardiovascular

Aztreonam for injection:
Uncommon (0.1% to 1%): Hypotension (less than 1%), transient electrocardiogram changes (ventricular bigeminy, premature ventricular contractions; less than 1%)

Nervous system

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Seizure, headache, confusion, vertigo, paresthesia, insomnia, dizziness, tinnitus

Musculoskeletal

Aztreonam for inhalation:
Postmarketing reports: Arthralgia, joint swelling

Aztreonam for injection:
Uncommon (0.1% to 1%): Muscular aches (less than 1%)

Renal

Aztreonam for injection:
Rare (less than 0.1%): Acute interstitial nephritis (at least 1 case)
Frequency not reported: Increased serum creatinine

Acute interstitial nephritis associated with aztreonam has been reported in a very ill patient receiving many other medications.

Genitourinary

Aztreonam for injection:
Uncommon (0.1% to 1%): Less than 1%: Vaginal candidiasis, vaginitis, breast tenderness

Ocular

Aztreonam for injection:
Uncommon (0.1% to 1%): Diplopia (less than 1%)

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