Drug · FAERS side-effect profile with label screen
Imipenem and Cilastatin side effects: what 4,053 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Imipenem And Cilastatin Sodium (Imipenem And Cilastatin)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,053 reports · 88% serious · 954 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Imipenem and Cilastatin for Injection, USP for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: Lower respiratory tract infections. ( 1.1 ) Urinary tract infections. ( 1.2 ) Intra-abdominal infections. ( 1.3 ) Gynecologic infections.
FDA label, Indications and Usage
What it is
Imipenem and Cilastatin for Injection, USP (I.V.) (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer.
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 6Labeled (related wording) 5Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 19
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 161 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 |
|---|---|---|---|---|---|---|
| Multi-organ failure | 79 | 23.4 18.8–29.1ROR 23.8 · χ² 1,666 / p <1e-300 | 23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · 99% clinician | no trial data cached |
| Grand mal convulsion | 42 | 23.3 17.2–31.5ROR 23.5 · χ² 871 / p 1e-191 | 23.0 EB05 17.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 92% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 55 | 18.9 14.6–24.6ROR 19.2 · χ² 914 / p 5e-201 | 18.8 EB05 14.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 92% clinician | no trial data cached |
| Toxic skin eruption | 36 | 18.5 13.4–25.6ROR 18.7 · χ² 577 / p 1e-127 | 18.2 EB05 13.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Convulsion (seizure) | 191 | 17.1 14.9–19.6ROR 17.9 · χ² 2,876 / p <1e-300 | 17.0 EB05 15.1 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 98% clinician | no trial data cached |
| Status epilepticus | 35 | 16.1 11.5–22.3ROR 16.2 · χ² 478 / p 3e-106 | 15.8 EB05 11.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · 91% clinician | no trial data cached |
| Septic shock | 127 | 15.2 12.8–18.1ROR 15.7 · χ² 1,675 / p <1e-300 | 15.2 EB05 13.1 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.0 · 97% clinician | no trial data cached |
| Clostridium difficile colitis | 31 | 15.1 10.7–21.5ROR 15.3 · χ² 395 / p 4e-88 | 14.8 EB05 10.7 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.1 · 90% clinician | no trial data cached |
| Disseminated intravascular coagulation | 38 | 14.0 10.2–19.2ROR 14.1 · χ² 443 / p 1e-98 | 13.7 EB05 10.2 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 | no trial data cached |
| Drug resistance | 65 | 13.1 10.3–16.7ROR 13.3 · χ² 715 / p 8e-158 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · 98% clinician | no trial data cached |
| Eosinophilia | 43 | 12.8 9.5–17.2ROR 12.9 · χ² 454 / p 5e-101 | 12.4 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 93% clinician | no trial data cached |
| Acute respiratory distress syndrome | 43 | 12.6 9.4–17.0ROR 12.7 · χ² 447 / p 1e-99 | 12.3 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 93% clinician | no trial data cached |
| Epilepsy | 73 | 12.4 9.9–15.6ROR 12.6 · χ² 753 / p 4e-166 | 12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 99% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 39 | 10.9 8.0–15.0ROR 11.0 · χ² 342 / p 1e-76 | 10.5 EB05 7.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 92% clinician | no trial data cached |
| Rash maculo-papular | 46 | 10.8 8.1–14.4ROR 10.9 · χ² 397 / p 1e-88 | 10.4 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 96% clinician | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 45 | 10.5 7.8–14.0ROR 10.6 · χ² 376 / p 5e-84 | 10.0 EB05 7.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Electrocardiogram qt prolonged | 71 | 10.2 8.1–12.9ROR 10.4 · χ² 582 / p 8e-129 | 9.9 EB05 8.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.8 | no trial data cached |
| Nephropathy toxic | 20 | 9.3 6.0–14.4ROR 9.3 · χ² 140 / p 1e-32 | 8.2 EB05 5.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 95% clinician | no trial data cached |
| Neutrophil count increased | 18 | 9.1 5.7–14.4ROR 9.1 · χ² 121 / p 2e-28 | 7.9 EB05 5.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 | no trial data cached |
| Lymphocyte count decreased | 30 | 8.8 6.2–12.6ROR 8.8 · χ² 199 / p 2e-45 | 8.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 · 100% clinician | no trial data cached |
| Myoclonus | 20 | 8.7 5.6–13.5ROR 8.7 · χ² 128 / p 5e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 100% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 36 | 8.4 6.1–11.7ROR 8.5 · χ² 228 / p 9e-52 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · 94% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 36 | 8.4 6.1–11.6ROR 8.5 · χ² 228 / p 1e-51 | 7.8 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · 97% clinician | no trial data cached |
| Blood urea increased | 27 | 8.3 5.7–12.1ROR 8.4 · χ² 166 / p 2e-38 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 · 96% clinician | no trial data cached |
| Drug eruption | 28 | 8.2 5.7–11.9ROR 8.3 · χ² 171 / p 3e-39 | 7.5 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 96% clinician | no trial data cached |
| Bone marrow failure | 32 | 8.1 5.7–11.4ROR 8.2 · χ² 192 / p 5e-44 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Altered state of consciousness | 33 | 7.9 5.6–11.1ROR 8.0 · χ² 193 / p 3e-44 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 94% clinician | no trial data cached |
| Respiratory failure | 110 | 7.8 6.5–9.4ROR 8.0 · χ² 648 / p 4e-143 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 93% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 42 | 7.8 5.8–10.5ROR 7.9 · χ² 242 / p 7e-55 | 7.3 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 98% clinician | no trial data cached |
| Shock | 34 | 7.7 5.5–10.8ROR 7.8 · χ² 192 / p 5e-44 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Cholestasis (bile flow blockage) | 28 | 7.6 5.3–11.0ROR 7.6 · χ² 154 / p 1e-35 | 6.9 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Bacteraemia | 17 | 7.5 4.7–12.0ROR 7.5 · χ² 89 / p 2e-21 | 6.4 EB05 4.2 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.9 | no trial data cached |
| Generalised tonic-clonic seizure | 23 | 7.3 4.8–10.9ROR 7.3 · χ² 118 / p 7e-28 | 6.5 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.8 · ♀ 18% (drug 43%) · 91% clinician | no trial data cached |
| Sepsis (blood infection) | 153 | 7.1 6.1–8.3ROR 7.3 · χ² 799 / p 4e-176 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 92% clinician | no trial data cached |
| Renal failure acute | 59 | 7.1 5.5–9.2ROR 7.2 · χ² 303 / p 3e-68 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 · 91% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 25 | 6.9 4.6–10.1ROR 6.9 · χ² 119 / p 4e-28 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Tuberculosis | 17 | 6.8 4.3–11.0ROR 6.9 · χ² 79 / p 3e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Generalised oedema | 16 | 6.7 4.1–11.0ROR 6.8 · χ² 72 / p 9e-18 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 142 | 6.6 5.6–7.8ROR 6.8 · χ² 671 / p 2e-148 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 93% clinician | no trial data cached |
| Atelectasis | 12 | 6.4 3.6–11.3ROR 6.4 · χ² 49 / p 1e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | 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 |
|---|---|---|---|---|---|---|
| Product use in unapproved indication | 299 | 6.3 5.7–7.1ROR 6.8 · χ² 1,354 / p 1e-296 | 6.3 EB05 5.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 97% clinician | no trial data cached |
| Convulsion (seizure) | 191 | 17.1 14.9–19.6ROR 17.9 · χ² 2,876 / p <1e-300 | 17.0 EB05 15.1 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 98% clinician | no trial data cached |
| Sepsis (blood infection) | 153 | 7.1 6.1–8.3ROR 7.3 · χ² 799 / p 4e-176 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 92% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 142 | 6.6 5.6–7.8ROR 6.8 · χ² 671 / p 2e-148 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 93% clinician | no trial data cached |
| Septic shock | 127 | 15.2 12.8–18.1ROR 15.7 · χ² 1,675 / p <1e-300 | 15.2 EB05 13.1 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.0 · 97% clinician | no trial data cached |
| Anaemia (low red blood cells) | 112 | 3.0 2.5–3.6ROR 3.1 · χ² 152 / p 3e-35 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Respiratory failure | 110 | 7.8 6.5–9.4ROR 8.0 · χ² 648 / p 4e-143 | 7.6 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 93% clinician | no trial data cached |
| Platelet count decreased | 98 | 4.8 3.9–5.8ROR 4.9 · χ² 289 / p 4e-65 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Drug interaction | 94 | 3.1 2.5–3.7ROR 3.1 · χ² 130 / p 2e-30 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 | no trial data cached |
| Renal failure (kidney failure) | 83 | 3.2 2.6–4.0ROR 3.3 · χ² 125 / p 3e-29 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Multi-organ failure | 79 | 23.4 18.8–29.1ROR 23.8 · χ² 1,666 / p <1e-300 | 23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · 99% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 73 | 2.8 2.2–3.5ROR 2.8 · χ² 82 / p 5e-20 | 2.8 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 · 90% clinician | no trial data cached |
| Epilepsy | 73 | 12.4 9.9–15.6ROR 12.6 · χ² 753 / p 4e-166 | 12.2 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 99% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 71 | 10.2 8.1–12.9ROR 10.4 · χ² 582 / p 8e-129 | 9.9 EB05 8.1 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.8 | no trial data cached |
| Drug resistance | 65 | 13.1 10.3–16.7ROR 13.3 · χ² 715 / p 8e-158 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.6 · 98% 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.
- Multi-organ failure — n=79, PRR 23.4
- Grand mal convulsion — n=42, PRR 23.3
- Toxic skin eruption — n=36, PRR 18.5
- Status epilepticus — n=35, PRR 16.1
- Eosinophilia — n=43, PRR 12.8
- Acute respiratory distress syndrome — n=43, PRR 12.6
- Epilepsy — n=73, PRR 12.4
- Rash maculo-papular — n=46, PRR 10.8
- Nephropathy toxic — n=20, PRR 9.3
- Drug eruption — n=28, PRR 8.2
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 Imipenem and Cilastatin?
In FDA FAERS, the most frequently co-reported reaction terms for Imipenem and Cilastatin are convulsion, sepsis, thrombocytopenia, septic shock, anaemia, respiratory failure. 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 Imipenem and Cilastatin have an FDA boxed warning?
No. The FDA label retrieved for Imipenem and Cilastatin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Imipenem and Cilastatin 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 0a1dd9b9-ada1-4bff-9dcb-18961254e9e8, effective 20221010; matched on
openfda.generic_name.exact:"IMIPENEM AND CILASTATIN SODIUM") - 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, 201 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.