Drug · FAERS side-effect profile with label screen
Ceftazidime side effects: what 7,635 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,635 reports · 96% serious · 1,731 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ceftazidime for injection, USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: Lower Respiratory Tract Infections , including pneumonia, caused by Pseudomon.
FDA label, Indications and Usage
What it is
DESCRIPTION Ceftazidime is a semisynthetic, broad-spectrum, beta-lactam antibacterial drug for parenteral administration. It is the pentahydrate of pyridinium, 1-[[7-[[(2-amino-4-thiazolyl)[(1.
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 5Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 23
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. 366 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 |
|---|---|---|---|---|---|---|
| Hyperbilirubinaemia | 113 | 30.5 25.3–36.6ROR 30.9 · χ² 3,155 / p <1e-300 | 30.0 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · 94% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 121 | 22.2 18.6–26.5ROR 22.6 · χ² 2,412 / p <1e-300 | 22.0 EB05 18.9 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · 93% clinician | no trial data cached |
| Septic shock | 341 | 21.8 19.7–24.2ROR 22.8 · χ² 6,719 / p <1e-300 | 21.6 EB05 19.8 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.0 | no trial data cached |
| Mucosal inflammation | 183 | 19.4 16.8–22.4ROR 19.9 · χ² 3,160 / p <1e-300 | 19.3 EB05 17.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · 97% clinician | no trial data cached |
| Drug resistance | 177 | 19.1 16.5–22.1ROR 19.5 · χ² 2,992 / p <1e-300 | 18.9 EB05 16.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 · 94% clinician | no trial data cached |
| Clostridium difficile colitis | 72 | 18.7 14.9–23.6ROR 18.9 · χ² 1,184 / p 8e-260 | 18.5 EB05 15.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 186 | 18.4 16.0–21.2ROR 18.9 · χ² 3,031 / p <1e-300 | 18.3 EB05 16.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 93% clinician | no trial data cached |
| Disseminated intravascular coagulation | 94 | 18.4 15.0–22.5ROR 18.6 · χ² 1,520 / p <1e-300 | 18.2 EB05 15.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Renal tubular necrosis | 62 | 17.4 13.6–22.3ROR 17.6 · χ² 938 / p 3e-206 | 17.2 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 157 | 17.0 14.5–19.8ROR 17.3 · χ² 2,333 / p <1e-300 | 16.8 EB05 14.7 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 · 96% clinician | no trial data cached |
| Multi-organ failure | 94 | 14.8 12.1–18.1ROR 15.0 · χ² 1,189 / p 6e-261 | 14.6 EB05 12.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Intraocular pressure increased (raised eye pressure) | 67 | 14.4 11.3–18.3ROR 14.5 · χ² 818 / p 3e-180 | 14.2 EB05 11.5 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 · ♀ 0% (drug 44%) | no trial data cached |
| Eosinophilia | 89 | 14.1 11.4–17.3ROR 14.2 · χ² 1,062 / p 3e-233 | 13.9 EB05 11.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Cholestasis (bile flow blockage) | 97 | 14.0 11.5–17.1ROR 14.2 · χ² 1,155 / p 2e-253 | 13.9 EB05 11.7 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 · 96% clinician | no trial data cached |
| Uveitis | 68 | 13.9 11.0–17.6ROR 14.0 · χ² 797 / p 1e-175 | 13.7 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 6% (drug 44%) | no trial data cached |
| Rash maculo-papular | 111 | 13.8 11.5–16.6ROR 14.0 · χ² 1,302 / p 2e-285 | 13.7 EB05 11.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 94% clinician | no trial data cached |
| Toxic skin eruption | 49 | 13.4 10.1–17.7ROR 13.5 · χ² 546 / p 4e-121 | 13.1 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 92% clinician | no trial data cached |
| Generalised oedema | 56 | 12.5 9.7–16.3ROR 12.6 · χ² 581 / p 1e-128 | 12.3 EB05 9.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 73% (drug 44%) | no trial data cached |
| Candida infection (yeast infection) | 75 | 12.4 9.9–15.5ROR 12.5 · χ² 772 / p 4e-170 | 12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 97% clinician | no trial data cached |
| Febrile neutropenia | 273 | 11.4 10.1–12.8ROR 11.8 · χ² 2,568 / p <1e-300 | 11.3 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 95% clinician | no trial data cached |
| Bacteraemia | 47 | 11.0 8.3–14.6ROR 11.1 · χ² 416 / p 8e-93 | 10.6 EB05 8.2 · IC025 +2.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.7 · 95% clinician | no trial data cached |
| Peritonitis bacterial | 39 | 10.7 7.8–14.6ROR 10.7 · χ² 331 / p 2e-74 | 10.2 EB05 7.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.4 | no trial data cached |
| Transfusion | 40 | 10.5 7.7–14.3ROR 10.5 · χ² 333 / p 1e-74 | 10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 90% clinician | no trial data cached |
| Status epilepticus | 43 | 10.5 7.8–14.1ROR 10.5 · χ² 358 / p 4e-80 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 93% clinician | no trial data cached |
| Abscess | 59 | 10.2 7.9–13.2ROR 10.3 · χ² 479 / p 2e-106 | 9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · ♀ 100% (drug 44%) | no trial data cached |
| Nerve compression | 34 | 10.2 7.3–14.2ROR 10.2 · χ² 271 / p 3e-61 | 9.6 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 100% (drug 44%) | no trial data cached |
| Respiratory failure | 260 | 9.8 8.7–11.1ROR 10.1 · χ² 2,050 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 91% clinician | no trial data cached |
| Cytomegalovirus infection | 58 | 9.6 7.4–12.4ROR 9.7 · χ² 437 / p 2e-97 | 9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Peritonitis | 72 | 9.6 7.6–12.1ROR 9.7 · χ² 543 / p 2e-120 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.8 · ♀ 71% (drug 44%) | no trial data cached |
| Acute respiratory distress syndrome | 61 | 9.5 7.4–12.2ROR 9.6 · χ² 454 / p 4e-101 | 9.1 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Myoclonus | 41 | 9.5 7.0–12.9ROR 9.5 · χ² 301 / p 8e-68 | 8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Bacterial infection | 62 | 9.2 7.2–11.8ROR 9.3 · χ² 444 / p 9e-99 | 8.8 EB05 7.1 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.2 | no trial data cached |
| Hepatic cytolysis | 40 | 9.0 6.6–12.3ROR 9.1 · χ² 276 / p 2e-62 | 8.5 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 84% (drug 44%) · 98% clinician | no trial data cached |
| Hepatocellular injury | 46 | 8.9 6.7–11.9ROR 9.0 · χ² 314 / p 1e-70 | 8.4 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 98% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 179 | 8.8 7.7–10.2ROR 9.0 · χ² 1,237 / p 2e-271 | 8.7 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Ascites | 94 | 8.8 7.2–10.8ROR 8.9 · χ² 641 / p 9e-142 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatomegaly | 31 | 8.6 6.1–12.3ROR 8.7 · χ² 202 / p 5e-46 | 7.9 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 76% (drug 44%) | no trial data cached |
| Neurotoxicity | 54 | 8.6 6.6–11.2ROR 8.6 · χ² 352 / p 7e-79 | 8.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 94% clinician | no trial data cached |
| Blood bilirubin increased | 84 | 8.5 6.9–10.6ROR 8.6 · χ² 551 / p 4e-122 | 8.3 EB05 6.9 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 · ♀ 66% (drug 44%) | no trial data cached |
| Gamma-glutamyltransferase increased | 68 | 8.4 6.7–10.7ROR 8.5 · χ² 438 / p 2e-97 | 8.1 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · ♀ 69% (drug 44%) | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 870 | 1.8 1.7–1.9ROR 1.9 · χ² 339 / p 5e-76 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.0 · 94% clinician | no trial data cached |
| Off label use (used outside approved label) | 682 | 2.2 2.0–2.3ROR 2.3 · χ² 441 / p 3e-98 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Pyrexia (fever) | 542 | 4.3 4.0–4.7ROR 4.6 · χ² 1,393 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Septic shock | 341 | 21.8 19.7–24.2ROR 22.8 · χ² 6,719 / p <1e-300 | 21.6 EB05 19.8 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.0 | no trial data cached |
| Condition aggravated | 336 | 3.1 2.8–3.4ROR 3.2 · χ² 470 / p 2e-104 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 327 | 6.6 6.0–7.4ROR 6.9 · χ² 1,568 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 318 | 5.7 5.2–6.4ROR 6.0 · χ² 1,248 / p 1e-273 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 96% clinician | no trial data cached |
| Pneumonia (lung infection) | 301 | 2.6 2.3–2.9ROR 2.6 · χ² 289 / p 5e-65 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 1.6 | no trial data cached |
| Febrile neutropenia | 273 | 11.4 10.1–12.8ROR 11.8 · χ² 2,568 / p <1e-300 | 11.3 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 95% clinician | no trial data cached |
| Hypotension (low blood pressure) | 269 | 3.7 3.3–4.2ROR 3.8 · χ² 530 / p 2e-117 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Sepsis (blood infection) | 269 | 6.6 5.9–7.5ROR 6.8 · χ² 1,285 / p 9e-282 | 6.6 EB05 5.9 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.0 · 92% clinician | no trial data cached |
| Respiratory failure | 260 | 9.8 8.7–11.1ROR 10.1 · χ² 2,050 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 91% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 229 | 5.7 5.0–6.4ROR 5.8 · χ² 875 / p 2e-192 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 92% clinician | no trial data cached |
| Anaemia (low red blood cells) | 219 | 3.2 2.8–3.6ROR 3.2 · χ² 323 / p 2e-72 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Multiple organ dysfunction syndrome | 186 | 18.4 16.0–21.2ROR 18.9 · χ² 3,031 / p <1e-300 | 18.3 EB05 16.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · 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.
- Hyperbilirubinaemia — n=113, PRR 30.5
- Mucosal inflammation — n=183, PRR 19.4
- Multiple organ dysfunction syndrome — n=186, PRR 18.4
- Disseminated intravascular coagulation — n=94, PRR 18.4
- Renal tubular necrosis — n=62, PRR 17.4
- Multi-organ failure — n=94, PRR 14.8
- Uveitis — n=68, PRR 13.9
- Rash maculo-papular — n=111, PRR 13.8
- Toxic skin eruption — n=49, PRR 13.4
- Generalised oedema — n=56, PRR 12.5
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 Ceftazidime?
In FDA FAERS, the most frequently co-reported reaction terms for Ceftazidime are pyrexia, septic shock, neutropenia, acute kidney injury, pneumonia, febrile neutropenia. 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 Ceftazidime have an FDA boxed warning?
No. The FDA label retrieved for Ceftazidime has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ceftazidime 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 aec64360-8452-4987-a366-a5a4f8762ab6, effective 20240103; matched on
openfda.generic_name.exact:"CEFTAZIDIME") - 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, 406 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.