Drug · FAERS side-effect profile with label screen
Ertapenem side effects: what 4,072 FDA adverse event reports show
Drug class
Penem antibacterial
FDA label, Indications wording
Brand names
Ertapenem Sodium
openFDA label
Who reports
4,072 reports · 92% serious · 350 with death outcome · 52% 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 9Labeled (related wording) 7Likely indication confounding 1Reporting / coding artifact 3Not in label — unassessed 20
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. 134 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 | 778 | 359.9 336.9–384.4ROR 444.7 · χ² 259,842 / p <1e-300 | 333.4 EB05 314.2 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious PRR 226.2 · ♀ 100% (drug 52%) | no trial data cached |
| Vaginal discharge | 163 | 84.9 73.0–98.8ROR 88.4 · χ² 13,221 / p <1e-300 | 82.8 EB05 72.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=163 · ♀ 100% (drug 52%) | no trial data cached |
| Paraesthesia oral | 214 | 77.8 68.2–88.8ROR 82.1 · χ² 15,921 / p <1e-300 | 76.2 EB05 68.0 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 85.4 · ♀ 100% (drug 52%) | no trial data cached |
| Oral candidiasis (oral thrush) | 170 | 68.2 58.8–79.1ROR 71.1 · χ² 11,043 / p <1e-300 | 66.8 EB05 58.8 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 58.8 · ♀ 97% (drug 52%) | no trial data cached |
| Clostridium difficile colitis | 81 | 39.6 31.9–49.1ROR 40.4 · χ² 2,985 / p <1e-300 | 38.9 EB05 32.3 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.0 · 96% clinician | no trial data cached |
| Procedural pain | 194 | 36.4 31.7–41.7ROR 38.1 · χ² 6,600 / p <1e-300 | 36.0 EB05 31.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 38.8 · ♀ 100% (drug 52%) | no trial data cached |
| Frequent bowel movements | 165 | 31.8 27.3–36.9ROR 33.1 · χ² 4,862 / p <1e-300 | 31.5 EB05 27.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 30.4 · ♀ 100% (drug 52%) | no trial data cached |
| Encephalopathy | 124 | 26.2 22.0–31.2ROR 27.0 · χ² 2,968 / p <1e-300 | 26.0 EB05 22.4 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.2 · 94% clinician | no trial data cached |
| Colitis | 170 | 23.3 20.1–27.1ROR 24.3 · χ² 3,603 / p <1e-300 | 23.2 EB05 20.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 · ♀ 97% (drug 52%) | no trial data cached |
| Rectal haemorrhage | 166 | 19.9 17.1–23.1ROR 20.7 · χ² 2,955 / p <1e-300 | 19.8 EB05 17.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 · ♀ 100% (drug 52%) | no trial data cached |
| Neurotoxicity | 66 | 19.6 15.4–24.9ROR 19.9 · χ² 1,145 / p 3e-251 | 19.5 EB05 15.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 · 91% clinician | no trial data cached |
| Colitis ulcerative | 165 | 19.1 16.5–22.2ROR 19.9 · χ² 2,810 / p <1e-300 | 19.0 EB05 16.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 99% (drug 52%) | no trial data cached |
| Clostridium difficile infection | 76 | 18.1 14.5–22.6ROR 18.4 · χ² 1,209 / p 3e-265 | 18.0 EB05 14.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.8 · ♀ 75% (drug 52%) | no trial data cached |
| Status epilepticus | 37 | 16.9 12.2–23.3ROR 17.0 · χ² 536 / p 8e-119 | 16.6 EB05 12.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · 97% clinician | no trial data cached |
| Drug resistance | 83 | 16.7 13.5–20.7ROR 17.0 · χ² 1,206 / p 1e-264 | 16.6 EB05 13.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · ♀ 23% (drug 52%) · 98% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 213 | 16.7 14.6–19.0ROR 17.5 · χ² 3,119 / p <1e-300 | 16.6 EB05 14.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 96% (drug 52%) | no trial data cached |
| Therapeutic product effect incomplete | 223 | 16.3 14.3–18.5ROR 17.2 · χ² 3,185 / p <1e-300 | 16.2 EB05 14.5 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · ♀ 98% (drug 52%) | no trial data cached |
| Haematochezia (blood in stool) | 169 | 15.8 13.7–18.4ROR 16.5 · χ² 2,333 / p <1e-300 | 15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · ♀ 97% (drug 52%) | no trial data cached |
| Myoclonus | 36 | 15.6 11.3–21.6ROR 15.7 · χ² 476 / p 8e-106 | 15.3 EB05 11.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 · ♀ 26% (drug 52%) · 94% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 69 | 13.9 11.0–17.6ROR 14.2 · χ² 815 / p 2e-179 | 13.8 EB05 11.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · ♀ 31% (drug 52%) · 97% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 39 | 12.3 9.0–16.8ROR 12.4 · χ² 393 / p 9e-88 | 11.9 EB05 8.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Eosinophilia | 41 | 12.1 8.9–16.4ROR 12.2 · χ² 406 / p 1e-90 | 11.7 EB05 8.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · ♀ 19% (drug 52%) · 92% clinician | no trial data cached |
| Nephropathy toxic | 26 | 12.0 8.2–17.7ROR 12.1 · χ² 252 / p 5e-57 | 11.4 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 10% (drug 52%) | no trial data cached |
| Urosepsis | 21 | 11.8 7.7–18.0ROR 11.8 · χ² 196 / p 9e-45 | 10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Hallucination, visual | 47 | 11.6 8.7–15.4ROR 11.7 · χ² 442 / p 2e-98 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 94% clinician | no trial data cached |
| Renal tubular necrosis | 21 | 11.0 7.2–16.9ROR 11.1 · χ² 181 / p 1e-41 | 10.1 EB05 6.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Mental status changes | 57 | 10.6 8.2–13.7ROR 10.7 · χ² 485 / p 1e-107 | 10.2 EB05 8.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 98% clinician | no trial data cached |
| Dyspepsia (indigestion) | 197 | 10.4 9.0–11.9ROR 10.8 · χ² 1,661 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 · ♀ 99% (drug 52%) | no trial data cached |
| Epilepsy | 61 | 10.3 8.0–13.2ROR 10.5 · χ² 503 / p 9e-112 | 10.0 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 95% clinician | no trial data cached |
| Erythema multiforme | 17 | 9.4 5.8–15.1ROR 9.4 · χ² 119 / p 5e-28 | 8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 17 | 9.2 5.7–14.8ROR 9.2 · χ² 116 / p 2e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Serotonin syndrome | 34 | 9.2 6.6–12.8ROR 9.2 · χ² 239 / p 3e-54 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 0% (drug 52%) · 97% clinician | no trial data cached |
| Drug level increased | 28 | 8.7 6.0–12.6ROR 8.8 · χ² 183 / p 4e-42 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Coagulopathy | 27 | 8.4 5.8–12.2ROR 8.4 · χ² 168 / p 1e-38 | 7.6 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 77% (drug 52%) · 93% clinician | no trial data cached |
| Bacteraemia | 19 | 8.3 5.3–13.0ROR 8.4 · χ² 115 / p 4e-27 | 7.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.2 | no trial data cached |
| Delirium | 54 | 8.1 6.2–10.5ROR 8.1 · χ² 327 / p 3e-73 | 7.7 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · ♀ 28% (drug 52%) | no trial data cached |
| Malnutrition | 17 | 7.9 4.9–12.7ROR 7.9 · χ² 95 / p 8e-23 | 6.8 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Metabolic acidosis | 47 | 7.7 5.8–10.2ROR 7.7 · χ² 265 / p 6e-60 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 95% clinician | no trial data cached |
| Bone marrow failure | 30 | 7.6 5.3–10.8ROR 7.6 · χ² 164 / p 7e-38 | 6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 7% (drug 52%) | no trial data cached |
| Scar | 25 | 7.5 5.1–11.1ROR 7.6 · χ² 135 / p 2e-31 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 91% (drug 52%) | 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) | 1,024 | 4.0 3.8–4.2ROR 5.0 · χ² 2,461 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 85% (drug 52%) | no trial data cached |
| Macular degeneration | 778 | 359.9 336.9–384.4ROR 444.7 · χ² 259,842 / p <1e-300 | 333.4 EB05 314.2 · IC025 +8.0 3/3 methods agree | Not in label — unassessed | serious PRR 226.2 · ♀ 100% (drug 52%) | no trial data cached |
| Off label use (used outside approved label) | 410 | 2.4 2.2–2.7ROR 2.6 · χ² 360 / p 2e-80 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Pyrexia (fever) | 366 | 5.4 4.9–6.0ROR 5.9 · χ² 1,346 / p 7e-295 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 73% (drug 52%) | no trial data cached |
| Pain | 289 | 2.4 2.2–2.7ROR 2.5 · χ² 246 / p 8e-56 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · ♀ 95% (drug 52%) | no trial data cached |
| Weight decreased (weight loss) | 250 | 4.6 4.1–5.2ROR 4.9 · χ² 714 / p 2e-157 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 · ♀ 90% (drug 52%) | no trial data cached |
| Malaise (feeling unwell) | 233 | 2.7 2.4–3.1ROR 2.8 · χ² 259 / p 1e-58 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · ♀ 97% (drug 52%) | no trial data cached |
| Anaemia (low red blood cells) | 225 | 6.1 5.4–6.9ROR 6.4 · χ² 957 / p 2e-210 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 82% (drug 52%) | no trial data cached |
| Therapeutic product effect incomplete | 223 | 16.3 14.3–18.5ROR 17.2 · χ² 3,185 / p <1e-300 | 16.2 EB05 14.5 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · ♀ 98% (drug 52%) | no trial data cached |
| Paraesthesia oral | 214 | 77.8 68.2–88.8ROR 82.1 · χ² 15,921 / p <1e-300 | 76.2 EB05 68.0 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 85.4 · ♀ 100% (drug 52%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 213 | 16.7 14.6–19.0ROR 17.5 · χ² 3,119 / p <1e-300 | 16.6 EB05 14.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 96% (drug 52%) | no trial data cached |
| Abdominal pain | 209 | 4.6 4.1–5.3ROR 4.8 · χ² 598 / p 3e-132 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · ♀ 90% (drug 52%) | no trial data cached |
| Dyspepsia (indigestion) | 197 | 10.4 9.0–11.9ROR 10.8 · χ² 1,661 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 · ♀ 99% (drug 52%) | no trial data cached |
| Procedural pain | 194 | 36.4 31.7–41.7ROR 38.1 · χ² 6,600 / p <1e-300 | 36.0 EB05 31.9 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 38.8 · ♀ 100% (drug 52%) | no trial data cached |
| Confusional state (confusion) | 191 | 6.1 5.3–7.0ROR 6.3 · χ² 811 / p 1e-178 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 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.
- Macular degeneration — n=778, PRR 359.9
- Vaginal discharge — n=163, PRR 84.9
- Frequent bowel movements — n=165, PRR 31.8
- Neurotoxicity — n=66, PRR 19.6
- Colitis ulcerative — n=165, PRR 19.1
- Status epilepticus — n=37, PRR 16.9
- Infusion related reaction — n=213, PRR 16.7
- Nephropathy toxic — n=26, PRR 12.0
- Urosepsis — n=21, PRR 11.8
- Hallucination, visual — n=47, PRR 11.6
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, pain, weight decreased, malaise, anaemia. 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, 174 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.