Drug · FAERS side-effect profile with label screen
Aztreonam side effects: what 7,146 FDA adverse event reports show
Drug class
Monobactam Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
7,146 reports · 75% serious · 978 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA label, Indications and Usage
What it is
DESCRIPTION Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam. It was originally isolated from Chromobacterium violaceum . It is a synthetic bactericidal antibiotic.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 5Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 26
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 242 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eosinophilia | 183 | 31.0 26.9–35.8ROR 31.8 · χ² 5,240 / p <1e-300 | 30.6 EB05 27.1 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.6 · 93% clinician | no trial data cached |
| Atelectasis | 72 | 21.9 17.4–27.6ROR 22.2 · χ² 1,408 / p <1e-300 | 21.7 EB05 17.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 97% (drug 58%) · 93% clinician | no trial data cached |
| Bronchospasm (airway tightening) | 98 | 20.2 16.6–24.6ROR 20.5 · χ² 1,760 / p <1e-300 | 20.0 EB05 16.9 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 · ♀ 89% (drug 58%) | no trial data cached |
| Haemoptysis | 190 | 20.1 17.4–23.1ROR 20.6 · χ² 3,405 / p <1e-300 | 19.9 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Sleep disorder due to a general medical condition | 84 | 15.3 12.4–19.0ROR 15.5 · χ² 1,105 / p 2e-242 | 15.2 EB05 12.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 83% (drug 58%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 71 | 13.9 11.0–17.5ROR 14.0 · χ² 832 / p 3e-183 | 13.7 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Lung infection | 74 | 13.8 11.0–17.4ROR 14.0 · χ² 865 / p 2e-190 | 13.7 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Hepatic cytolysis | 56 | 13.5 10.4–17.5ROR 13.6 · χ² 633 / p 5e-140 | 13.3 EB05 10.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · ♀ 14% (drug 58%) · 98% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 114 | 13.1 11.0–15.8ROR 13.3 · χ² 1,263 / p 7e-277 | 13.0 EB05 11.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 · 94% clinician | no trial data cached |
| Sputum discoloured | 36 | 11.2 8.1–15.5ROR 11.3 · χ² 324 / p 1e-72 | 10.7 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Rash maculo-papular | 84 | 11.2 9.0–13.8ROR 11.3 · χ² 765 / p 1e-168 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 24% (drug 58%) · 95% clinician | no trial data cached |
| Sinus disorder | 68 | 10.1 8.0–12.8ROR 10.2 · χ² 546 / p 4e-121 | 9.8 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Rib fracture | 67 | 9.6 7.6–12.2ROR 9.7 · χ² 507 / p 2e-112 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 97% (drug 58%) | no trial data cached |
| Toxic skin eruption | 32 | 9.3 6.6–13.2ROR 9.4 · χ² 229 / p 6e-52 | 8.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 54 | 8.6 6.6–11.2ROR 8.6 · χ² 354 / p 3e-79 | 8.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · 96% clinician | no trial data cached |
| Leukocytosis | 52 | 8.5 6.4–11.1ROR 8.5 · χ² 334 / p 7e-75 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · ♀ 15% (drug 58%) · 98% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 129 | 8.0 6.8–9.5ROR 8.1 · χ² 785 / p 6e-173 | 7.8 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Impaired quality of life | 37 | 7.6 5.5–10.4ROR 7.6 · χ² 204 / p 2e-46 | 7.0 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 94% (drug 58%) | no trial data cached |
| Hospitalisation | 390 | 7.5 6.8–8.3ROR 7.9 · χ² 2,211 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Drug resistance | 65 | 7.4 5.8–9.5ROR 7.5 · χ² 356 / p 1e-79 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | no trial data cached |
| Septic shock | 105 | 7.1 5.9–8.6ROR 7.2 · χ² 548 / p 1e-121 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.5 · 94% clinician | no trial data cached |
| Acute respiratory failure | 46 | 7.1 5.3–9.4ROR 7.1 · χ² 233 / p 7e-53 | 6.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Wheezing | 141 | 7.0 5.9–8.3ROR 7.1 · χ² 720 / p 5e-159 | 6.9 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Respiratory failure | 169 | 6.8 5.9–7.9ROR 6.9 · χ² 832 / p 2e-183 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Hepatocellular injury | 32 | 6.6 4.7–9.4ROR 6.6 · χ² 147 / p 4e-34 | 6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Cholestasis (bile flow blockage) | 41 | 6.3 4.6–8.6ROR 6.3 · χ² 178 / p 8e-41 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 90% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 52 | 6.1 4.7–8.1ROR 6.2 · χ² 219 / p 9e-50 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 35% (drug 58%) | no trial data cached |
| Loss of personal independence in daily activities | 94 | 5.8 4.8–7.1ROR 5.9 · χ² 370 / p 1e-82 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pneumothorax | 31 | 5.7 4.0–8.2ROR 5.8 · χ² 117 / p 2e-27 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.4 | no trial data cached |
| Renal tubular necrosis | 19 | 5.7 3.6–8.9ROR 5.7 · χ² 69 / p 6e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Multi-organ failure | 33 | 5.5 3.9–7.8ROR 5.5 · χ² 118 / p 1e-27 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Shock | 41 | 5.3 3.9–7.2ROR 5.3 · χ² 138 / p 4e-32 | 5.0 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 92% clinician | no trial data cached |
| Clostridium difficile colitis | 19 | 5.3 3.4–8.2ROR 5.3 · χ² 61 / p 3e-15 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Laceration | 17 | 5.2 3.3–8.4ROR 5.2 · χ² 54 / p 1e-13 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Infection | 249 | 5.1 4.5–5.7ROR 5.2 · χ² 815 / p 2e-179 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.1 | no trial data cached |
| Obstructive airways disorder | 19 | 5.0 3.2–7.8ROR 5.0 · χ² 57 / p 2e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Staphylococcal infection | 54 | 4.8 3.7–6.3ROR 4.8 · χ² 158 / p 1e-36 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Sinus congestion | 22 | 4.8 3.1–7.3ROR 4.8 · χ² 62 / p 2e-15 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Secretion discharge | 20 | 4.8 3.1–7.4ROR 4.8 · χ² 56 / p 5e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Candida infection (yeast infection) | 27 | 4.8 3.3–6.9ROR 4.8 · χ² 76 / p 1e-18 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 440 | 2.3 2.1–2.5ROR 2.4 · χ² 325 / p 7e-73 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hospitalisation | 390 | 7.5 6.8–8.3ROR 7.9 · χ² 2,211 / p <1e-300 | 7.5 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Cough | 359 | 3.8 3.4–4.2ROR 3.9 · χ² 736 / p 2e-162 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Death | 302 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.318 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.8 | no trial data cached |
| Pneumonia (lung infection) | 297 | 2.7 2.4–3.0ROR 2.8 · χ² 320 / p 7e-72 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 2.1 | no trial data cached |
| Pyrexia (fever) | 294 | 2.5 2.2–2.8ROR 2.6 · χ² 265 / p 5e-60 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Infection | 249 | 5.1 4.5–5.7ROR 5.2 · χ² 815 / p 2e-179 | 5.0 EB05 4.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.1 | no trial data cached |
| Condition aggravated | 214 | 2.1 1.8–2.4ROR 2.1 · χ² 121 / p 2e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Rash | 207 | 1.4 1.2–1.6ROR 1.4 · χ² 24 / p 5e-7 | 1.4 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Haemoptysis | 190 | 20.1 17.4–23.1ROR 20.6 · χ² 3,405 / p <1e-300 | 19.9 EB05 17.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Eosinophilia | 183 | 31.0 26.9–35.8ROR 31.8 · χ² 5,240 / p <1e-300 | 30.6 EB05 27.1 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 24.6 · 93% clinician | no trial data cached |
| Respiratory failure | 169 | 6.8 5.9–7.9ROR 6.9 · χ² 832 / p 2e-183 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Anxiety | 168 | 1.7 1.5–2.0ROR 1.7 · χ² 51 / p 4e-13 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 · ♀ 78% (drug 58%) | no trial data cached |
| Drug hypersensitivity | 162 | 2.4 2.1–2.9ROR 2.5 · χ² 139 / p 3e-32 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · ♀ 80% (drug 58%) | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 143 | 2.8 2.3–3.2ROR 2.8 · χ² 159 / p 8e-37 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 93% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Atelectasis — n=72, PRR 21.9
- Haemoptysis — n=190, PRR 20.1
- Sleep disorder due to a general medical condition — n=84, PRR 15.3
- Lung infection — n=74, PRR 13.8
- Hepatic cytolysis — n=56, PRR 13.5
- Sputum discoloured — n=36, PRR 11.2
- Rash maculo-papular — n=84, PRR 11.2
- Sinus disorder — n=68, PRR 10.1
- Rib fracture — n=67, PRR 9.6
- Toxic skin eruption — n=32, PRR 9.3
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aztreonam?
In FDA FAERS, the most frequently co-reported reaction terms for Aztreonam are dyspnoea, cough, pneumonia, pyrexia, infection, rash. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aztreonam have an FDA boxed warning?
No. The FDA label retrieved for Aztreonam has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aztreonam causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 302fd27d-0a22-44ea-91fb-1b1ffcf17a1f, effective 20220430; matched on
openfda.generic_name.exact:"AZTREONAM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 282 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.