Meropenem side effects: what 31,902 FDA adverse event reports show
Drug class
Penem antibacterial
Who reports
31,902 reports · 97% serious · 9,524 with death outcome · 43% female
Used for
Meropenem for injection (I.V.) is a penem antibacterial indicated for the treatment of: 4. Complicated skin and skin structure infections (adult patients and pediatric patients 3 months of age and older only). ( 1.1 ) 5. Complicated intra-abdominal infections (adult and pediatric patients). ( 1.2 ) 6. Bacterial meningitis (pediatric patients 3 months of age and older only).
What it is
Meropenem for injection, USP (I.V.) is a sterile, pyrogen-free, synthetic, carbapenem antibacterial for intravenous administration. It is (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid trihydrate.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,126 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Neonatal candida infection | 18 | 466.3 254.4–854.5ROR 466.5 · calibrated p 8e-12 ✓ | 211.0 EB05 141.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Meningitis candida | 23 | 338.5 204.5–560.5ROR 338.8 · calibrated p 5e-11 ✓ | 188.1 EB05 132.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 · 100% clinician | not reported in cached trials |
| Geotrichum infection | 60 | 259.0 192.1–349.4ROR 259.5 · calibrated p 9e-11 ✓ | 175.1 EB05 140.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=60 · 96% clinician | not reported in cached trials |
| Protothecosis | 26 | 251.3 159.8–395.2ROR 251.5 · calibrated p 4e-10 ✓ | 160.2 EB05 114.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 43%) | not reported in cached trials |
| Intracranial infection | 25 | 168.6 108.6–261.9ROR 168.8 · calibrated p 8e-9 ✓ | 121.8 EB05 86.7 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 43%) · 100% clinician | not reported in cached trials |
| Foetal anaemia | 24 | 146.6 94.2–228.3ROR 146.7 · calibrated p 3e-8 ✓ | 109.5 EB05 77.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 43%) | not reported in cached trials |
| Trichosporon infection | 64 | 126.7 97.0–165.7ROR 127.0 · calibrated p 3e-8 ✓ | 103.0 EB05 83.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=64 · 100% clinician | not reported in cached trials |
| Rhinocerebral mucormycosis | 52 | 117.7 87.6–158.2ROR 117.9 · calibrated p 6e-8 ✓ | 96.3 EB05 76.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=52 · 100% clinician | not reported in cached trials |
| Herpes simplex oesophagitis | 27 | 115.0 76.4–173.2ROR 115.1 · calibrated p 1e-7 ✓ | 91.7 EB05 66.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 43%) | not reported in cached trials |
| Disseminated mucormycosis | 51 | 99.5 74.1–133.6ROR 99.6 · calibrated p 2e-7 ✓ | 83.7 EB05 66.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=51 · 100% clinician | not reported in cached trials |
| Aeromonas infection | 23 | 99.3 64.0–154.0ROR 99.4 · calibrated p 4e-7 ✓ | 80.7 EB05 56.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Perinephric abscess | 20 | 98.9 61.8–158.3ROR 98.9 · calibrated p 5e-7 ✓ | 79.6 EB05 54.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Urinary tract candidiasis | 24 | 95.9 62.5–147.3ROR 96.0 · calibrated p 5e-7 ✓ | 78.6 EB05 55.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Emphysematous pyelonephritis | 23 | 93.7 60.5–145.0ROR 93.7 · calibrated p 6e-7 ✓ | 76.9 EB05 54.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Dysbiosis | 98 | 91.6 74.1–113.1ROR 91.9 · calibrated p 3e-7 ✓ | 79.2 EB05 66.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=98 · 97% clinician | not reported in cached trials |
| Acinetobacter infection | 121 | 82.7 68.4–99.8ROR 83.0 · calibrated p 6e-7 ✓ | 72.6 EB05 62.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=121 · 97% clinician | not reported in cached trials |
| Systemic candida | 268 | 80.1 70.5–90.8ROR 80.7 · calibrated p 6e-7 ✓ | 71.0 EB05 64.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=268 · 94% clinician | not reported in cached trials |
| Factor v inhibition | 20 | 74.4 46.9–118.2ROR 74.5 · calibrated p 3e-6 ✓ | 63.0 EB05 43.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Spinal muscular atrophy | 25 | 67.2 44.5–101.4ROR 67.2 · calibrated p 5e-6 ✓ | 58.4 EB05 41.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 43%) · 100% clinician | not reported in cached trials |
| Congenital multiplex arthrogryposis | 19 | 66.5 41.5–106.6ROR 66.6 · calibrated p 7e-6 ✓ | 57.1 EB05 38.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Stenotrophomonas infection | 121 | 65.2 54.1–78.6ROR 65.5 · calibrated p 3e-6 ✓ | 58.8 EB05 50.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=121 · 91% clinician | not reported in cached trials |
| Positive airway pressure therapy | 21 | 64.8 41.4–101.4ROR 64.8 · calibrated p 7e-6 ✓ | 56.1 EB05 38.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=21 | not reported in cached trials |
| Cns ventriculitis | 29 | 63.9 43.6–93.5ROR 63.9 · calibrated p 6e-6 ✓ | 56.2 EB05 41.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=29 | NCT01808092: 1/403 (0.2%) on Meropenem (serious AE) |
| Conductive deafness | 28 | 62.3 42.3–91.8ROR 62.4 · calibrated p 7e-6 ✓ | 54.9 EB05 39.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 43%) | not reported in cached trials |
| Fungaemia | 131 | 60.0 50.2–71.8ROR 60.3 · calibrated p 5e-6 ✓ | 54.6 EB05 47.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=131 · 98% clinician | not reported in cached trials |
| Scedosporium infection | 57 | 58.9 44.9–77.2ROR 59.0 · calibrated p 7e-6 ✓ | 53.1 EB05 42.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=57 · 95% clinician | not reported in cached trials |
| Fusarium infection | 56 | 58.6 44.6–77.0ROR 58.7 · calibrated p 7e-6 ✓ | 52.9 EB05 42.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=56 | not reported in cached trials |
| Cerebral nocardiosis | 17 | 56.7 34.6–93.2ROR 56.8 · calibrated p 2e-5 ✓ | 49.5 EB05 32.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Fungal endocarditis | 23 | 55.8 36.4–85.4ROR 55.8 · calibrated p 2e-5 ✓ | 49.5 EB05 34.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Enterococcal sepsis | 56 | 48.4 36.9–63.4ROR 48.4 · calibrated p 2e-5 ✓ | 44.4 EB05 35.5 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=56 | not reported in cached trials |
| Enterococcal infection | 332 | 48.3 43.3–54.0ROR 48.8 · calibrated p 2e-5 ✓ | 45.0 EB05 41.0 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=331 · 93% clinician | not reported in cached trials |
| Systemic mycosis | 80 | 48.3 38.5–60.6ROR 48.4 · calibrated p 2e-5 ✓ | 44.6 EB05 37.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=79 · 92% clinician | not reported in cached trials |
| Clostridium test positive | 146 | 47.1 39.8–55.7ROR 47.3 · calibrated p 2e-5 ✓ | 43.8 EB05 38.1 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=145 · 93% clinician | not reported in cached trials |
| Candida sepsis | 59 | 46.1 35.4–60.0ROR 46.2 · calibrated p 3e-5 ✓ | 42.5 EB05 34.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 72% (drug 43%) · 91% clinician | not reported in cached trials |
| Hyphaema | 34 | 45.5 32.1–64.4ROR 45.5 · calibrated p 4e-5 ✓ | 41.7 EB05 31.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 43%) | not reported in cached trials |
| Disseminated aspergillosis | 30 | 44.9 31.0–65.0ROR 44.9 · calibrated p 5e-5 ✓ | 41.0 EB05 30.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Infective aneurysm | 31 | 44.5 30.9–64.0ROR 44.6 · calibrated p 5e-5 ✓ | 40.8 EB05 30.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 43%) · 90% clinician | not reported in cached trials |
| Procalcitonin increased | 73 | 44.3 35.0–56.2ROR 44.4 · calibrated p 4e-5 ✓ | 41.2 EB05 33.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=73 · 92% clinician | not reported in cached trials |
| Fungal sepsis | 53 | 44.3 33.6–58.6ROR 44.4 · calibrated p 4e-5 ✓ | 41.0 EB05 32.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=53 · 94% clinician | not reported in cached trials |
| Vancomycin infusion reaction | 23 | 44.3 29.1–67.6ROR 44.4 · calibrated p 6e-5 ✓ | 40.3 EB05 28.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious n=23 · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Meropenem as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT01808092 — A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia (N=969, PHASE3; 114 AE terms posted; arms: CAZ-AVI; Meropenem)
- NCT02070757 — Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) (N=726, PHASE3; 159 AE terms posted; arms: Ceftolozane/Tazobactam; Meropenem)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 4,483 | 2.2 2.2–2.3ROR 2.4 · calibrated p 0.837 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 93% clinician | not reported in cached trials |
| Off label use (used outside approved label) | 3,305 | 2.5 2.4–2.6ROR 2.7 · calibrated p 0.739 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 93% clinician | not reported in cached trials |
| Pyrexia (fever) | 2,177 | 4.2 4.0–4.3ROR 4.4 · calibrated p 0.313 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 · 92% clinician | NCT01808092: 1/405 (0.2%) on Meropenem (serious AE) |
| Pneumonia (lung infection) | 1,487 | 3.0 2.9–3.2ROR 3.1 · calibrated p 0.585 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 1.9 · 90% clinician | NCT01808092: 1/405 (0.2%) on Meropenem (serious AE) |
| Septic shock | 1,423 | 22.4 21.2–23.5ROR 23.3 · calibrated p 9e-4 ✓ | 21.6 EB05 20.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · 94% clinician | NCT01808092: 3/403 (0.7%) on Meropenem (serious AE) |
| Sepsis (blood infection) | 1,410 | 8.4 8.0–8.8ROR 8.7 · calibrated p 0.050 | 8.3 EB05 7.9 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 93% clinician | NCT01808092: 2/403 (0.5%) on Meropenem (serious AE) |
| Multiple organ dysfunction syndrome | 1,309 | 32.3 30.6–34.1ROR 33.7 · calibrated p 1e-4 ✓ | 30.8 EB05 29.4 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.3 · 94% clinician | not reported in cached trials |
| Acute kidney injury (sudden kidney damage) | 1,284 | 5.6 5.3–5.9ROR 5.8 · calibrated p 0.166 | 5.5 EB05 5.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 95% clinician | NCT01808092: 1/403 (0.2%) on Meropenem (serious AE) |
| Condition aggravated | 1,240 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.704 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 95% clinician | not reported in cached trials |
| Febrile neutropenia | 1,133 | 11.4 10.8–12.1ROR 11.8 · calibrated p 0.018 ✓ | 11.2 EB05 10.7 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 93% clinician | not reported in cached trials |
| Thrombocytopenia (low platelets) | 1,128 | 6.7 6.3–7.1ROR 6.9 · calibrated p 0.102 | 6.6 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 94% clinician | NCT02070757: 1/359 (0.3%) on Meropenem (serious AE) |
| Diarrhoea (diarrhea) | 1,118 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.405 | 1.1 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.2 · 91% clinician | NCT01808092: 1/405 (0.2%) on Meropenem (serious AE) |
| Respiratory failure | 1,118 | 10.2 9.6–10.8ROR 10.5 · calibrated p 0.027 ✓ | 10.1 EB05 9.6 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 93% clinician | NCT01808092: 1/403 (0.2%) on Meropenem (serious AE) |
| Drug interaction | 960 | 4.0 3.8–4.3ROR 4.1 · calibrated p 0.362 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 96% clinician | not reported in cached trials |
| Neutropenia (low neutrophils (infection-fighting cells)) | 937 | 4.6 4.3–4.9ROR 4.7 · calibrated p 0.273 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 95% clinician | not reported in cached trials |
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.
- Geotrichum infection — n=60, PRR 259.0
- Protothecosis — n=26, PRR 251.3
- Intracranial infection — n=25, PRR 168.6
- Foetal anaemia — n=24, PRR 146.6
- Trichosporon infection — n=64, PRR 126.7
- Rhinocerebral mucormycosis — n=52, PRR 117.7
- Herpes simplex oesophagitis — n=27, PRR 115.0
- Disseminated mucormycosis — n=51, PRR 99.5
- Aeromonas infection — n=23, PRR 99.3
- Perinephric abscess — n=20, PRR 98.9
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 Meropenem?
In FDA FAERS, the most frequently co-reported reaction terms for Meropenem are pyrexia, pneumonia, septic shock, sepsis, multiple organ dysfunction syndrome, acute kidney injury. 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 Meropenem have an FDA boxed warning?
No. The FDA label retrieved for Meropenem has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Meropenem 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 092ebd9b-77a0-4877-afc3-dd8211730f71, effective 20241106; matched on
openfda.generic_name.exact:"MEROPENEM") - 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, 1,166 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 - ClinicalTrials.gov API v2 (query
MEROPENEM, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.