Drug · FAERS side-effect profile with label screen
Imipenem and Cilastatin side effects: what 1,694 FDA adverse event reports show
Drug class
Penem Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
1,694 reports · 96% serious · 396 with death outcome · 42% 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.
FDA label, Indications and Usage
What it is
Imipenem and Cilastatin for Injection, USP is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. Imipenem and Cilastatin for Injection, USP is an antibacterial drug for intravenous administration.
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 4Reporting / coding artifact 4Lab value / disease marker 4Not in label — unassessed 17
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. 30 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 |
|---|---|---|---|---|---|---|
| Toxic skin eruption | 22 | 27.0 17.8–40.9ROR 27.3 · χ² 524 / p 2e-116 | 26.4 EB05 18.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | no trial data cached |
| Electrocardiogram qt prolonged | 64 | 22.0 17.3–28.0ROR 22.9 · χ² 1,265 / p 2e-277 | 21.9 EB05 17.7 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.4 | no trial data cached |
| Drug resistance | 41 | 19.8 14.6–26.8ROR 20.3 · χ² 712 / p 3e-157 | 19.6 EB05 15.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 13.0 · 100% clinician | no trial data cached |
| Neutrophil count increased | 15 | 18.1 10.9–29.9ROR 18.2 · χ² 225 / p 3e-51 | 17.4 EB05 10.7 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 11.9 | no trial data cached |
| Epilepsy | 42 | 17.1 12.7–23.0ROR 17.5 · χ² 619 / p 6e-137 | 16.9 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Rash maculo-papular | 30 | 16.8 11.8–23.9ROR 17.1 · χ² 429 / p 1e-95 | 16.5 EB05 12.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 93% clinician | no trial data cached |
| Nephropathy toxic | 15 | 16.7 10.1–27.6ROR 16.8 · χ² 206 / p 6e-47 | 15.9 EB05 9.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Septic shock | 53 | 15.2 11.7–19.8ROR 15.7 · χ² 689 / p 3e-152 | 15.0 EB05 11.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 34 | 15.1 10.8–21.1ROR 15.4 · χ² 434 / p 1e-96 | 14.8 EB05 10.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 97% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 29 | 14.1 9.8–20.2ROR 14.3 · χ² 339 / p 5e-76 | 13.7 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 96% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 25 | 14.0 9.5–20.6ROR 14.2 · χ² 288 / p 6e-65 | 13.5 EB05 9.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 · 100% clinician | no trial data cached |
| Tuberculosis | 14 | 13.5 8.0–22.7ROR 13.6 · χ² 150 / p 1e-34 | 12.3 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Eosinophilia | 19 | 13.5 8.6–21.1ROR 13.6 · χ² 207 / p 3e-47 | 12.7 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Lymphocyte count decreased | 19 | 13.3 8.5–20.8ROR 13.4 · χ² 204 / p 1e-46 | 12.5 EB05 8.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.2 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 16 | 13.1 8.1–21.4ROR 13.3 · χ² 168 / p 1e-38 | 12.1 EB05 7.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Clostridium difficile colitis | 11 | 12.8 7.1–23.1ROR 12.9 · χ² 108 / p 1e-25 | 11.1 EB05 5.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Blood urea increased | 17 | 12.5 7.8–20.1ROR 12.6 · χ² 169 / p 7e-39 | 11.5 EB05 7.0 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | no trial data cached |
| Acute respiratory distress syndrome | 16 | 11.2 6.9–18.2ROR 11.3 · χ² 139 / p 3e-32 | 10.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Clostridium difficile infection | 19 | 10.9 6.9–17.0ROR 11.0 · χ² 160 / p 5e-37 | 9.8 EB05 6.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Cytomegalovirus infection | 14 | 10.4 6.2–17.6ROR 10.5 · χ² 110 / p 5e-26 | 8.9 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Myoclonus | 10 | 10.4 5.6–19.3ROR 10.4 · χ² 76 / p 2e-18 | 8.3 EB05 4.4 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Drug-induced liver injury | 25 | 10.0 6.8–14.8ROR 10.2 · χ² 195 / p 2e-44 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 14 | 9.4 5.6–15.8ROR 9.4 · χ² 97 / p 4e-23 | 7.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Generalised tonic-clonic seizure | 12 | 9.1 5.2–16.0ROR 9.1 · χ² 78 / p 4e-19 | 7.4 EB05 4.3 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.5 | no trial data cached |
| Bone marrow failure | 15 | 9.1 5.5–15.0ROR 9.2 · χ² 100 / p 8e-24 | 7.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 | no trial data cached |
| Device related infection | 11 | 8.8 4.9–15.9ROR 8.9 · χ² 69 / p 6e-17 | 7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Neurotoxicity | 12 | 8.6 4.9–15.0ROR 8.6 · χ² 73 / p 8e-18 | 6.9 EB05 4.1 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Respiratory failure | 50 | 8.5 6.5–11.2ROR 8.7 · χ² 324 / p 1e-72 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Encephalopathy | 16 | 8.1 5.0–13.2ROR 8.2 · χ² 92 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Thrombocytopenia (low platelets) | 70 | 7.8 6.2–9.8ROR 8.1 · χ² 408 / p 4e-91 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 93% clinician | no trial data cached |
| White blood cell count increased | 24 | 7.7 5.2–11.5ROR 7.8 · χ² 134 / p 3e-31 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 | no trial data cached |
| Altered state of consciousness | 13 | 7.5 4.3–12.8ROR 7.5 · χ² 67 / p 2e-16 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Candida infection (yeast infection) | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Hypocalcaemia (low calcium) | 11 | 7.2 4.0–13.0ROR 7.3 · χ² 53 / p 2e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Incorrect product administration duration | 11 | 6.7 3.7–12.1ROR 6.7 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Hepatic function abnormal | 20 | 6.7 4.3–10.3ROR 6.7 · χ² 91 / p 7e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.1 · 100% clinician | no trial data cached |
| Cholestasis (bile flow blockage) | 10 | 6.5 3.5–12.0ROR 6.5 · χ² 41 / p 7e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Leukopenia (low white blood cells) | 25 | 6.2 4.2–9.2ROR 6.3 · χ² 104 / p 9e-25 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Treatment failure | 38 | 5.7 4.2–7.9ROR 5.8 · χ² 144 / p 2e-33 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 95% clinician | no trial data cached |
| Pancreatitis acute | 10 | 5.5 3.0–10.3ROR 5.6 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | 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 |
|---|---|---|---|---|---|---|
| Thrombocytopenia (low platelets) | 70 | 7.8 6.2–9.8ROR 8.1 · χ² 408 / p 4e-91 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 93% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 64 | 22.0 17.3–28.0ROR 22.9 · χ² 1,265 / p 2e-277 | 21.9 EB05 17.7 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.4 | no trial data cached |
| Septic shock | 53 | 15.2 11.7–19.8ROR 15.7 · χ² 689 / p 3e-152 | 15.0 EB05 11.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.1 · 94% clinician | no trial data cached |
| Respiratory failure | 50 | 8.5 6.5–11.2ROR 8.7 · χ² 324 / p 1e-72 | 8.1 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Epilepsy | 42 | 17.1 12.7–23.0ROR 17.5 · χ² 619 / p 6e-137 | 16.9 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 100% clinician | no trial data cached |
| Drug resistance | 41 | 19.8 14.6–26.8ROR 20.3 · χ² 712 / p 3e-157 | 19.6 EB05 15.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 13.0 · 100% clinician | no trial data cached |
| Treatment failure | 38 | 5.7 4.2–7.9ROR 5.8 · χ² 144 / p 2e-33 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 34 | 15.1 10.8–21.1ROR 15.4 · χ² 434 / p 1e-96 | 14.8 EB05 10.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 97% clinician | no trial data cached |
| Rash maculo-papular | 30 | 16.8 11.8–23.9ROR 17.1 · χ² 429 / p 1e-95 | 16.5 EB05 12.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 93% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 29 | 14.1 9.8–20.2ROR 14.3 · χ² 339 / p 5e-76 | 13.7 EB05 9.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 96% clinician | no trial data cached |
| Leukopenia (low white blood cells) | 25 | 6.2 4.2–9.2ROR 6.3 · χ² 104 / p 9e-25 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Drug-induced liver injury | 25 | 10.0 6.8–14.8ROR 10.2 · χ² 195 / p 2e-44 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Hepatotoxicity (liver damage) | 25 | 14.0 9.5–20.6ROR 14.2 · χ² 288 / p 6e-65 | 13.5 EB05 9.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 · 100% clinician | no trial data cached |
| White blood cell count increased | 24 | 7.7 5.2–11.5ROR 7.8 · χ² 134 / p 3e-31 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 | no trial data cached |
| Toxic skin eruption | 22 | 27.0 17.8–40.9ROR 27.3 · χ² 524 / p 2e-116 | 26.4 EB05 18.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 | 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.
- Toxic skin eruption — n=22, PRR 27.0
- Epilepsy — n=42, PRR 17.1
- Rash maculo-papular — n=30, PRR 16.8
- Multiple organ dysfunction syndrome — n=34, PRR 15.1
- Drug reaction with eosinophilia and systemic symptoms — n=29, PRR 14.1
- Drug-induced liver injury — n=25, PRR 10.0
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 thrombocytopenia, electrocardiogram qt prolonged, septic shock, respiratory failure, epilepsy, multiple organ dysfunction syndrome. 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 46f54df9-5afe-430c-aa19-0d84c2044b0b, effective 20250116; matched on
openfda.generic_name.exact:"IMIPENEM AND CILASTATIN") - 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, 70 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.