What real-world harms show up with imipenem/cilastatin?
Among 2,574 FAERS reports, imipenem/cilastatin AEs clustered in older men, often within 3 days, with strong signals for delirium, disorganised speech, and some unlabeled events such as cerebral atrophy.
Source
Real-world pharmacovigilance investigation of imipenem/cilastatin: signal detection using the FDA Adverse Event Reporting System (FAERS) database
Study at a glance
- Design
- Other — FAERS disproportionality analysis of imipenem/cilastatin as primary suspect, 2004 Q1–2023 Q4 (ROR, PRR, BCPNN, EBGM)
- N
- N=2574 · 2,574 AE reports (6,605 AEs) with IMI/CIL as primary suspect
- Population
- Spontaneous FAERS reports worldwide in which imipenem/cilastatin was the primary suspect drug
- Outcome
- Adverse-event signals by MedDRA SOC/PT, including onset time and previously unlabeled events
Structured fields used in claim comparison tables when every cited study has a complete layer.
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What real-world harms show up with imipenem/cilastatin?
These passages occur verbatim in the stored paper text. They support the points listed below; they do not verify every statement in the explanation.
2,574 AE reports; 58.94% involved people aged over 60.
From the first quarter of 2004 to the fourth quarter of 2023, a total of 2,574 reports documenting AEs associated with IMI/CIL were obtained, with more than half (n = 1,517, 58.94%) involving individuals aged over 60 years old.
Male reports were 57.89% (n=1,490) vs female 39.86% (n=1,026).
In the ADR reports, there was a significantly higher proportion of male patients (n = 1,490, 57.89%) compared to female patients (n = 1,026, 39.86%).
What they did
Pulled FAERS cases with IMI/CIL as primary suspect (2004–2023) and ran ROR, PRR, BCPNN, and EBGM disproportionality analyses classified by MedDRA.
What they found
2,574 reports / 6,605 AEs; 57.89% male; 58.94% aged >60. Most AEs within 3 days. Signals spanned 24 SOCs. Unlabeled PTs included cerebral atrophy, toxic encephalopathy, language disorder, disorganised speech, dysphoria, and delirium (n=263, ROR 72.31).
The limits
What it doesn't show
Spontaneous reports cannot measure true incidence or prove causation; missing data, stimulated reporting, and no denominator limit risk estimates.
Key terms
- Imipenem/cilastatin (IMI/CIL)
- Carbapenem antibiotic plus renal dehydropeptidase inhibitor.
- FAERS
- FDA Adverse Event Reporting System of spontaneous safety reports.
- Primary suspect (PS)
- Reporter-designated drug most likely responsible for the AE.
- ROR
- Reporting odds ratio used to detect disproportionate AE signals.
- MedDRA PT/SOC
- Preferred terms nested in system organ classes for coding AEs.
- Disproportionality analysis
- Signal detection comparing how often an AE is reported with a drug vs others.
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Quiz yourself
FAERS PS reports numbered about:
Common questions
How many PS reports?
2,574 reports (6,605 AEs) from 2004–2023.
Who was over-represented?
Men (57.89%) and people >60 years (58.94%).
When did AEs occur?
Most within 3 days of starting the drug.
New signals?
Examples include cerebral atrophy, delirium, and disorganised speech.
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