Colistimethate side effects: what 1,576 FDA adverse event reports show

Colistimethate Sodium · Coly-Mycin M · 33 reaction terms · 622 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Coly-Mycin M

openFDA label

Who reports

1,576 reports · 87% serious · 195 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa . This antibiotic is not indicated for infections due to Proteus or Neisseria .

FDA label, Indications and Usage

What it is

DESCRIPTION Coly-Mycin ® M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution ), is suitable for intramuscular or 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 17 strongest signals

Likely indication confounding 1Reporting / coding artifact 4Not in label — unassessed 12

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.
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. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic cytolysis	33	36.0 25.7–50.5ROR 36.8 · χ² 1,087 / p 1e-238	35.3 EB05 26.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.8 · ♀ 0% (drug 50%) · 100% clinician	no trial data cached
Nephropathy toxic	24	28.7 19.3–42.7ROR 29.2 · χ² 614 / p 8e-136	28.1 EB05 19.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 100% clinician	no trial data cached
Eosinophilia	36	27.5 19.9–38.0ROR 28.1 · χ² 891 / p 5e-196	27.1 EB05 20.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.0 · ♀ 3% (drug 50%) · 100% clinician	no trial data cached
Leukocytosis	35	25.8 18.6–35.8ROR 26.4 · χ² 809 / p 3e-178	25.4 EB05 19.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.5 · ♀ 0% (drug 50%) · 100% clinician	no trial data cached
Multiple organ dysfunction syndrome	41	19.6 14.5–26.5ROR 20.1 · χ² 704 / p 2e-155	19.4 EB05 14.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.9 · ♀ 72% (drug 50%) · 95% clinician	no trial data cached
Rash maculo-papular	31	18.6 13.2–26.4ROR 19.0 · χ² 500 / p 5e-111	18.4 EB05 13.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.7 · ♀ 7% (drug 50%) · 100% clinician	no trial data cached
Septic shock	53	16.3 12.5–21.3ROR 16.9 · χ² 748 / p 5e-165	16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 96% clinician	no trial data cached
Haemoptysis	28	13.3 9.2–19.3ROR 13.6 · χ² 307 / p 4e-69	12.9 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Acute respiratory failure	18	12.5 7.9–19.8ROR 12.7 · χ² 179 / p 3e-41	11.6 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Bacteraemia	11	12.4 6.9–22.4ROR 12.5 · χ² 105 / p 8e-25	10.6 EB05 5.6 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	no trial data cached
Hospitalisation	131	11.4 9.7–13.5ROR 12.4 · χ² 1,247 / p 2e-273	11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · 73% consumer	no trial data cached
Conjunctivitis	14	10.1 6.0–17.1ROR 10.2 · χ² 106 / p 3e-25	8.6 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Drug resistance	18	9.3 5.9–14.8ROR 9.4 · χ² 126 / p 2e-29	8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached
Gastric ulcer	10	7.0 3.8–13.0ROR 7.0 · χ² 46 / p 7e-12	5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	10	5.2 2.8–9.7ROR 5.2 · χ² 30 / p 2e-8	4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Exposure during pregnancy	16	3.4 2.1–5.6ROR 3.4 · χ² 25 / p 3e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Foetal exposure during pregnancy	15	2.5 1.5–4.1ROR 2.5 · χ² 12 / p 3e-4	2.3 EB05 1.5 · IC025 +0.4	Reporting / coding artifact	serious PRR 1.7	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
Hospitalisation	131	11.4 9.7–13.5ROR 12.4 · χ² 1,247 / p 2e-273	11.3 EB05 9.8 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.7 · 73% consumer	no trial data cached
Septic shock	53	16.3 12.5–21.3ROR 16.9 · χ² 748 / p 5e-165	16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.8 · 96% clinician	no trial data cached
Multiple organ dysfunction syndrome	41	19.6 14.5–26.5ROR 20.1 · χ² 704 / p 2e-155	19.4 EB05 14.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.9 · ♀ 72% (drug 50%) · 95% clinician	no trial data cached
Eosinophilia	36	27.5 19.9–38.0ROR 28.1 · χ² 891 / p 5e-196	27.1 EB05 20.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.0 · ♀ 3% (drug 50%) · 100% clinician	no trial data cached
Leukocytosis	35	25.8 18.6–35.8ROR 26.4 · χ² 809 / p 3e-178	25.4 EB05 19.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.5 · ♀ 0% (drug 50%) · 100% clinician	no trial data cached
Hepatic cytolysis	33	36.0 25.7–50.5ROR 36.8 · χ² 1,087 / p 1e-238	35.3 EB05 26.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.8 · ♀ 0% (drug 50%) · 100% clinician	no trial data cached
Rash maculo-papular	31	18.6 13.2–26.4ROR 19.0 · χ² 500 / p 5e-111	18.4 EB05 13.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.7 · ♀ 7% (drug 50%) · 100% clinician	no trial data cached
Haemoptysis	28	13.3 9.2–19.3ROR 13.6 · χ² 307 / p 4e-69	12.9 EB05 9.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.9	no trial data cached
Nephropathy toxic	24	28.7 19.3–42.7ROR 29.2 · χ² 614 / p 8e-136	28.1 EB05 19.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.5 · 100% clinician	no trial data cached
Drug resistance	18	9.3 5.9–14.8ROR 9.4 · χ² 126 / p 2e-29	8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6	no trial data cached
Acute respiratory failure	18	12.5 7.9–19.8ROR 12.7 · χ² 179 / p 3e-41	11.6 EB05 7.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Exposure during pregnancy	16	3.4 2.1–5.6ROR 3.4 · χ² 25 / p 3e-7	3.2 EB05 2.1 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial data cached
Foetal exposure during pregnancy	15	2.5 1.5–4.1ROR 2.5 · χ² 12 / p 3e-4	2.3 EB05 1.5 · IC025 +0.4	Reporting / coding artifact	serious PRR 1.7	no trial data cached
Conjunctivitis	14	10.1 6.0–17.1ROR 10.2 · χ² 106 / p 3e-25	8.6 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Bacteraemia	11	12.4 6.9–22.4ROR 12.5 · χ² 105 / p 8e-25	10.6 EB05 5.6 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 8.3	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.

Hepatic cytolysis — n=33, PRR 36.0
Nephropathy toxic — n=24, PRR 28.7
Eosinophilia — n=36, PRR 27.5
Leukocytosis — n=35, PRR 25.8
Multiple organ dysfunction syndrome — n=41, PRR 19.6
Rash maculo-papular — n=31, PRR 18.6
Septic shock — n=53, PRR 16.3
Haemoptysis — n=28, PRR 13.3

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 Colistimethate?

In FDA FAERS, the most frequently co-reported reaction terms for Colistimethate are septic shock, multiple organ dysfunction syndrome, eosinophilia, leukocytosis, hepatic cytolysis, rash maculo-papular. 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 Colistimethate have an FDA boxed warning?

No. The FDA label retrieved for Colistimethate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Colistimethate 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 6d6e13e2-dc33-4b7b-84d0-66146a57c552, effective 20260608; matched on openfda.generic_name.exact:"COLISTIMETHATE")
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, field patient.drug.openfda.generic_name.exact, 33 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.