Drug · FAERS side-effect profile with label screen
Piperacillin and Tazobactam side effects: what 12,716 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,716 reports · 97% serious · 2,658 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Piperacillin and Tazobactam for Injection, USP is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: Intra-abdominal infections in adult and pediatric patients 2 m.
FDA label, Indications and Usage
What it is
Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin.
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 (related wording) 4Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 26
What the badges mean
- 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. 1,007 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 |
|---|---|---|---|---|---|---|
| Pyelonephritis fungal | 12 | 325.2 175.0–604.3ROR 325.5 · χ² 2,968 / p <1e-300 | 189.8 EB05 115.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| New onset refractory status epilepticus | 10 | 171.2 89.2–328.3ROR 171.3 · χ² 1,381 / p <1e-300 | 120.1 EB05 69.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Retinitis viral | 10 | 150.6 78.8–287.7ROR 150.7 · χ² 1,226 / p 6e-269 | 109.7 EB05 63.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Perinephric abscess | 12 | 140.4 77.9–253.1ROR 140.5 · χ² 1,403 / p <1e-300 | 107.7 EB05 65.6 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Pulmonary interstitial emphysema syndrome | 11 | 137.6 74.4–254.6ROR 137.7 · χ² 1,252 / p 1e-274 | 104.5 EB05 62.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Geotrichum infection | 16 | 134.1 80.6–223.2ROR 134.3 · χ² 1,832 / p <1e-300 | 108.3 EB05 70.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Gastrointestinal mucormycosis | 11 | 122.5 66.4–226.1ROR 122.6 · χ² 1,122 / p 2e-246 | 95.6 EB05 57.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Trichosporon infection | 26 | 115.8 77.8–172.4ROR 116.1 · χ² 2,657 / p <1e-300 | 100.4 EB05 72.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 42%) · 100% clinician | no trial data cached |
| Emphysematous pyelonephritis | 12 | 114.8 63.9–206.1ROR 114.9 · χ² 1,160 / p 1e-254 | 92.0 EB05 56.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Intra-abdominal pressure increased | 10 | 112.1 59.1–212.8ROR 112.2 · χ² 929 / p 2e-204 | 87.9 EB05 51.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Spinal muscular atrophy | 17 | 111.0 67.9–181.4ROR 111.2 · χ² 1,634 / p <1e-300 | 93.4 EB05 61.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Pyroglutamic acidosis | 22 | 101.3 65.9–155.9ROR 101.5 · χ² 1,964 / p <1e-300 | 88.4 EB05 61.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Alveolar lung disease | 11 | 100.5 54.7–184.7ROR 100.6 · χ² 929 / p 3e-204 | 81.7 EB05 48.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Choroiditis | 20 | 92.7 59.1–145.4ROR 92.8 · χ² 1,630 / p <1e-300 | 81.1 EB05 55.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 · 90% clinician | no trial data cached |
| Acid base balance abnormal | 12 | 92.0 51.5–164.6ROR 92.1 · χ² 938 / p 2e-206 | 76.9 EB05 46.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Portal fibrosis | 11 | 90.3 49.2–165.8ROR 90.4 · χ² 838 / p 1e-184 | 74.9 EB05 44.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Linear iga disease | 77 | 80.0 63.6–100.4ROR 80.4 · χ² 5,648 / p <1e-300 | 74.9 EB05 61.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% clinician | no trial data cached |
| Positive airway pressure therapy | 10 | 73.6 39.1–138.6ROR 73.6 · χ² 617 / p 1e-136 | 62.5 EB05 36.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Antibiotic level above therapeutic | 17 | 73.1 45.0–118.9ROR 73.2 · χ² 1,089 / p 3e-239 | 65.1 EB05 43.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Clostridium test positive | 87 | 68.5 55.3–84.8ROR 68.9 · χ² 5,487 / p <1e-300 | 64.9 EB05 54.2 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=87 · 94% clinician | no trial data cached |
| Stoma closure | 12 | 68.2 38.3–121.5ROR 68.3 · χ² 700 / p 2e-154 | 59.6 EB05 36.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rhinocerebral mucormycosis | 13 | 65.0 37.4–113.2ROR 65.1 · χ² 728 / p 1e-160 | 57.6 EB05 35.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pneumococcal sepsis | 24 | 63.1 42.0–94.8ROR 63.2 · χ² 1,352 / p 3e-296 | 58.1 EB05 41.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · ♀ 0% (drug 42%) · 100% clinician | no trial data cached |
| Disseminated mucormycosis | 14 | 61.7 36.2–105.2ROR 61.8 · χ² 748 / p 5e-165 | 55.3 EB05 35.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Symmetrical drug-related intertriginous and flexural exanthema | 28 | 60.3 41.4–87.9ROR 60.4 · χ² 1,518 / p <1e-300 | 56.1 EB05 40.7 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 · ♀ 62% (drug 42%) · 100% clinician | no trial data cached |
| Antimicrobial susceptibility test resistant | 11 | 60.2 33.0–109.9ROR 60.3 · χ² 562 / p 2e-124 | 53.1 EB05 31.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Necrosis ischaemic | 16 | 59.0 35.8–97.1ROR 59.1 · χ² 825 / p 9e-182 | 53.5 EB05 34.9 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Intensive care unit acquired weakness | 13 | 58.1 33.4–101.0ROR 58.1 · χ² 650 / p 1e-143 | 52.1 EB05 32.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Respiratory tract infection bacterial | 15 | 50.9 30.5–85.1ROR 51.0 · χ² 664 / p 9e-147 | 46.7 EB05 30.0 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Pneumatosis | 13 | 49.6 28.6–86.1ROR 49.7 · χ² 555 / p 6e-123 | 45.2 EB05 28.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Systemic candida | 69 | 47.4 37.3–60.2ROR 47.7 · χ² 3,001 / p <1e-300 | 45.5 EB05 37.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=69 · 100% clinician | no trial data cached |
| Enterococcus test positive | 18 | 46.8 29.3–74.7ROR 46.8 · χ² 740 / p 4e-163 | 43.5 EB05 29.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Lower respiratory tract infection bacterial | 14 | 46.1 27.1–78.4ROR 46.1 · χ² 557 / p 2e-123 | 42.4 EB05 26.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Hyperferritinaemia | 11 | 44.9 24.7–81.8ROR 45.0 · χ² 418 / p 3e-93 | 40.9 EB05 24.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Motor neurone disease | 13 | 44.8 25.8–77.7ROR 44.8 · χ² 500 / p 5e-111 | 41.2 EB05 25.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Respiratory tract infection fungal | 14 | 44.6 26.3–75.9ROR 44.7 · χ² 540 / p 1e-119 | 41.2 EB05 26.1 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Neutrophilic dermatosis | 10 | 42.5 22.7–79.5ROR 42.5 · χ² 355 / p 2e-79 | 38.6 EB05 22.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pseudomonal bacteraemia | 20 | 40.3 25.8–62.7ROR 40.3 · χ² 709 / p 1e-156 | 38.0 EB05 26.0 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=20 | no trial data cached |
| Gastroduodenal ulcer | 10 | 40.3 21.5–75.4ROR 40.3 · χ² 336 / p 2e-75 | 36.8 EB05 21.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Fungaemia | 36 | 38.8 27.9–54.0ROR 38.9 · χ² 1,259 / p 5e-276 | 37.3 EB05 28.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=36 · 100% clinician | 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) | 1,459 | 1.8 1.7–1.9ROR 1.9 · χ² 582 / p 6e-129 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.0 · 94% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,043 | 2.0 1.9–2.1ROR 2.1 · χ² 528 / p 3e-117 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.0 · 94% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 977 | 10.6 10.0–11.3ROR 11.4 · χ² 8,530 / p <1e-300 | 10.6 EB05 10.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 95% clinician | no trial data cached |
| Pyrexia (fever) | 897 | 4.3 4.0–4.6ROR 4.5 · χ² 2,284 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 92% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 490 | 7.3 6.7–7.9ROR 7.5 · χ² 2,647 / p <1e-300 | 7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 95% clinician | no trial data cached |
| Drug interaction | 482 | 5.0 4.6–5.5ROR 5.2 · χ² 1,555 / p <1e-300 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 94% clinician | no trial data cached |
| Pneumonia (lung infection) | 463 | 2.4 2.2–2.6ROR 2.4 · χ² 368 / p 2e-82 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 1.4 · 92% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 459 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.2 · 93% clinician | no trial data cached |
| Condition aggravated | 454 | 2.5 2.3–2.7ROR 2.5 · χ² 405 / p 2e-90 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 94% clinician | no trial data cached |
| Septic shock | 425 | 16.4 14.9–18.0ROR 16.9 · χ² 6,068 / p <1e-300 | 16.2 EB05 14.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 · 93% clinician | no trial data cached |
| Hypotension (low blood pressure) | 418 | 3.4 3.1–3.8ROR 3.5 · χ² 729 / p 8e-161 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 92% clinician | no trial data cached |
| Sepsis (blood infection) | 410 | 6.1 5.5–6.7ROR 6.2 · χ² 1,737 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 93% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 408 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 2e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 · 91% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 401 | 26.3 23.8–29.0ROR 27.1 · χ² 9,582 / p <1e-300 | 25.8 EB05 23.8 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.3 · 97% clinician | no trial data cached |
| Rash | 385 | 1.5 1.3–1.6ROR 1.5 · χ² 57 / p 2e-14 | 1.5 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.8 · 92% 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.
- Trichosporon infection — n=26, PRR 115.8
- Pyroglutamic acidosis — n=22, PRR 101.3
- Choroiditis — n=20, PRR 92.7
- Linear iga disease — n=77, PRR 80.0
- Systemic candida — n=69, PRR 47.4
- Fungaemia — n=36, PRR 38.8
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 Piperacillin and Tazobactam?
In FDA FAERS, the most frequently co-reported reaction terms for Piperacillin and Tazobactam are acute kidney injury, pyrexia, thrombocytopenia, pneumonia, diarrhoea, septic shock. 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 Piperacillin and Tazobactam have an FDA boxed warning?
No. The FDA label retrieved for Piperacillin and Tazobactam has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Piperacillin and Tazobactam 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 2c8f06a2-49b2-4169-94ef-182d13d248bf, effective 20250521; matched on
openfda.generic_name.exact:"PIPERACILLIN AND TAZOBACTAM") - 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, 1,047 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.