Treatment adherence
What real-world harms show up with imipenem/cilastatin?
Open access · cc by · source: Europe PMC
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.
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
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Key findings
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).
Methodology
Pulled FAERS cases with IMI/CIL as primary suspect (2004–2023) and ran ROR, PRR, BCPNN, and EBGM disproportionality analyses classified by MedDRA.
Limitations
Spontaneous reports cannot measure true incidence or prove causation; missing data, stimulated reporting, and no denominator limit risk estimates.
How this study connects
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