Drug · FAERS side-effect profile with label screen
Ertapenem Sodium side effects: what 7,339 FDA adverse event reports show
Drug class
Penem antibacterial
FDA label, Indications wording
Brand names
Ertapenem Sodium
openFDA label
Who reports
7,339 reports · 85% serious · 627 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2 ) Community-acquired pneumonia.
FDA label, Indications and Usage
What it is
Ertapenem for injection is a sterile, synthetic, parenteral, 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics.
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 12Labeled (related wording) 9Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 15
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.
- 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. 290 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 |
|---|---|---|---|---|---|---|
| Macular degeneration | 808 | 207.9 194.3–222.5ROR 233.5 · χ² 154,854 / p <1e-300 | 192.8 EB05 181.9 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 141.2 · ♀ 100% (drug 51%) | no trial data cached |
| Vaginal discharge | 166 | 48.0 41.2–55.9ROR 49.1 · χ² 7,469 / p <1e-300 | 47.0 EB05 41.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=166 · ♀ 100% (drug 51%) | no trial data cached |
| Paraesthesia oral | 222 | 44.8 39.3–51.1ROR 46.2 · χ² 9,325 / p <1e-300 | 44.0 EB05 39.3 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 52.7 · ♀ 98% (drug 51%) | no trial data cached |
| Oral candidiasis (oral thrush) | 177 | 39.4 34.0–45.6ROR 40.3 · χ² 6,499 / p <1e-300 | 38.7 EB05 34.2 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 36.4 · ♀ 96% (drug 51%) | no trial data cached |
| Clostridium difficile colitis | 107 | 29.1 24.1–35.1ROR 29.5 · χ² 2,845 / p <1e-300 | 28.7 EB05 24.4 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 · 95% clinician | no trial data cached |
| Procedural pain | 197 | 20.5 17.8–23.5ROR 21.0 · χ² 3,611 / p <1e-300 | 20.3 EB05 18.0 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.7 · ♀ 100% (drug 51%) | no trial data cached |
| Encephalopathy | 174 | 20.4 17.6–23.7ROR 20.9 · χ² 3,178 / p <1e-300 | 20.3 EB05 17.9 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.7 · 94% clinician | no trial data cached |
| Status epilepticus | 75 | 19.1 15.2–23.9ROR 19.2 · χ² 1,257 / p 1e-275 | 18.9 EB05 15.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 96% clinician | no trial data cached |
| Myoclonus | 77 | 18.6 14.9–23.2ROR 18.8 · χ² 1,255 / p 4e-275 | 18.4 EB05 15.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · ♀ 28% (drug 51%) · 92% clinician | no trial data cached |
| Frequent bowel movements | 168 | 17.9 15.4–20.9ROR 18.3 · χ² 2,658 / p <1e-300 | 17.8 EB05 15.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 100% (drug 51%) | no trial data cached |
| Epilepsy | 177 | 16.7 14.4–19.3ROR 17.1 · χ² 2,579 / p <1e-300 | 16.5 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 93% clinician | no trial data cached |
| Clostridium difficile infection | 109 | 14.4 12.0–17.4ROR 14.6 · χ² 1,344 / p 1e-294 | 14.3 EB05 12.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.0 · ♀ 73% (drug 51%) | no trial data cached |
| Neurotoxicity | 83 | 13.7 11.1–17.0ROR 13.9 · χ² 961 / p 2e-211 | 13.5 EB05 11.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Colitis | 177 | 13.5 11.7–15.6ROR 13.8 · χ² 2,027 / p <1e-300 | 13.4 EB05 11.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 · ♀ 96% (drug 51%) | no trial data cached |
| Hallucination, visual | 94 | 12.9 10.5–15.7ROR 13.0 · χ² 1,012 / p 2e-222 | 12.7 EB05 10.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 93% clinician | no trial data cached |
| Delirium | 147 | 12.2 10.4–14.3ROR 12.4 · χ² 1,496 / p <1e-300 | 12.1 EB05 10.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Convulsion (seizure) | 230 | 11.4 10.0–12.9ROR 11.7 · χ² 2,163 / p <1e-300 | 11.3 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Rectal haemorrhage | 169 | 11.2 9.7–13.1ROR 11.5 · χ² 1,563 / p <1e-300 | 11.1 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 · ♀ 100% (drug 51%) | no trial data cached |
| Colitis ulcerative | 168 | 10.8 9.3–12.5ROR 11.0 · χ² 1,482 / p <1e-300 | 10.7 EB05 9.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 100% (drug 51%) | no trial data cached |
| Generalised tonic-clonic seizure | 60 | 10.5 8.2–13.5ROR 10.6 · χ² 505 / p 3e-112 | 10.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 · 92% clinician | no trial data cached |
| Grand mal convulsion | 34 | 10.4 7.4–14.6ROR 10.4 · χ² 279 / p 7e-63 | 9.8 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 91% clinician | no trial data cached |
| Hallucination (hallucinations) | 264 | 10.1 9.0–11.4ROR 10.4 · χ² 2,154 / p <1e-300 | 10.0 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Drug resistance | 90 | 10.0 8.2–12.3ROR 10.2 · χ² 722 / p 2e-159 | 9.8 EB05 8.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 24% (drug 51%) · 97% clinician | no trial data cached |
| Mental status changes | 97 | 10.0 8.2–12.2ROR 10.1 · χ² 775 / p 7e-171 | 9.8 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 90% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 221 | 9.6 8.4–10.9ROR 9.9 · χ² 1,691 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 94% (drug 51%) | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 85 | 9.5 7.7–11.8ROR 9.6 · χ² 639 / p 2e-141 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 96% clinician | no trial data cached |
| Haematochezia (blood in stool) | 178 | 9.3 8.0–10.7ROR 9.5 · χ² 1,302 / p 2e-285 | 9.1 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · ♀ 94% (drug 51%) | no trial data cached |
| Therapeutic product effect incomplete | 226 | 9.2 8.1–10.4ROR 9.4 · χ² 1,634 / p <1e-300 | 9.0 EB05 8.1 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 · ♀ 98% (drug 51%) | no trial data cached |
| Urosepsis | 26 | 8.1 5.5–11.9ROR 8.1 · χ² 154 / p 1e-35 | 7.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Eosinophilia | 48 | 7.9 5.9–10.4ROR 7.9 · χ² 280 / p 3e-63 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 27% (drug 51%) · 93% clinician | no trial data cached |
| Bacteraemia | 32 | 7.8 5.5–11.0ROR 7.8 · χ² 182 / p 8e-42 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.3 · 97% clinician | no trial data cached |
| Confusional state (confusion) | 432 | 7.6 7.0–8.4ROR 8.1 · χ² 2,500 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 90% clinician | no trial data cached |
| Renal tubular necrosis | 26 | 7.6 5.2–11.1ROR 7.6 · χ² 141 / p 6e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 91% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 24 | 7.2 4.8–10.8ROR 7.2 · χ² 122 / p 1e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 100% clinician | no trial data cached |
| Osteomyelitis | 43 | 6.8 5.0–9.2ROR 6.8 · χ² 207 / p 3e-47 | 6.4 EB05 4.9 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.4 | no trial data cached |
| Nephropathy toxic | 26 | 6.7 4.6–9.8ROR 6.7 · χ² 120 / p 3e-28 | 6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Erythema multiforme | 21 | 6.4 4.2–9.9ROR 6.5 · χ² 91 / p 7e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial data cached |
| Dyspepsia (indigestion) | 208 | 6.1 5.3–6.9ROR 6.2 · χ² 878 / p 3e-193 | 6.0 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 · ♀ 97% (drug 51%) | no trial data cached |
| Seizure | 231 | 5.8 5.1–6.5ROR 5.9 · χ² 907 / p 1e-199 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Disorientation | 79 | 5.7 4.6–7.1ROR 5.7 · χ² 301 / p 1e-67 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | 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) | 1,152 | 2.5 2.4–2.6ROR 2.8 · χ² 1,105 / p 1e-242 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · ♀ 83% (drug 51%) | no trial data cached |
| Macular degeneration | 808 | 207.9 194.3–222.5ROR 233.5 · χ² 154,854 / p <1e-300 | 192.8 EB05 181.9 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious PRR 141.2 · ♀ 100% (drug 51%) | no trial data cached |
| Off label use (used outside approved label) | 528 | 1.7 1.6–1.9ROR 1.8 · χ² 172 / p 1e-39 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Pyrexia (fever) | 464 | 3.8 3.5–4.2ROR 4.0 · χ² 984 / p 3e-216 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Confusional state (confusion) | 432 | 7.6 7.0–8.4ROR 8.1 · χ² 2,500 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 90% clinician | no trial data cached |
| Product use in unapproved indication | 420 | 4.9 4.5–5.4ROR 5.2 · χ² 1,321 / p 2e-289 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 95% clinician | no trial data cached |
| Nausea | 396 | 1.4 1.3–1.6ROR 1.5 · χ² 54 / p 1e-13 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.8 · ♀ 81% (drug 51%) | no trial data cached |
| Pain | 343 | 1.6 1.4–1.8ROR 1.6 · χ² 77 / p 7e-19 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 · ♀ 92% (drug 51%) | no trial data cached |
| Weight decreased (weight loss) | 273 | 2.8 2.5–3.1ROR 2.9 · χ² 317 / p 3e-71 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · ♀ 88% (drug 51%) | no trial data cached |
| Malaise (feeling unwell) | 271 | 1.8 1.6–2.0ROR 1.8 · χ² 90 / p 1e-21 | 1.8 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 90% (drug 51%) | no trial data cached |
| Anaemia (low red blood cells) | 267 | 4.0 3.6–4.5ROR 4.1 · χ² 603 / p 2e-133 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · ♀ 77% (drug 51%) | no trial data cached |
| Hallucination (hallucinations) | 264 | 10.1 9.0–11.4ROR 10.4 · χ² 2,154 / p <1e-300 | 10.0 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Abdominal pain | 242 | 3.0 2.6–3.4ROR 3.0 · χ² 319 / p 1e-71 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · ♀ 87% (drug 51%) | no trial data cached |
| Seizure | 231 | 5.8 5.1–6.5ROR 5.9 · χ² 907 / p 1e-199 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Convulsion (seizure) | 230 | 11.4 10.0–12.9ROR 11.7 · χ² 2,163 / p <1e-300 | 11.3 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | 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.
- Macular degeneration — n=808, PRR 207.9
- Vaginal discharge — n=166, PRR 48.0
- Status epilepticus — n=75, PRR 19.1
- Frequent bowel movements — n=168, PRR 17.9
- Epilepsy — n=177, PRR 16.7
- Neurotoxicity — n=83, PRR 13.7
- Hallucination, visual — n=94, PRR 12.9
- Colitis ulcerative — n=168, PRR 10.8
- Grand mal convulsion — n=34, PRR 10.4
- Infusion related reaction — n=221, PRR 9.6
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 Ertapenem?
In FDA FAERS, the most frequently co-reported reaction terms for Ertapenem are macular degeneration, pyrexia, confusional state, nausea, pain, weight decreased. 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 Ertapenem have an FDA boxed warning?
No. The FDA label retrieved for Ertapenem has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ertapenem 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 2398d418-6efc-b4d2-3265-936001df9b8b, effective 20251224; matched on
openfda.generic_name.exact:"ERTAPENEM") - 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, 330 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.