Polymyxin B Sulfate side effects: what 1,563 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,563 reports · 86% serious · 287 with death outcome · 59% female
Used for
Acute Infections Caused by Susceptible Strains of Pseudomonas aeruginosa. Polymyxin B sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of Ps. aeruginosa . It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Ps. aeruginosa .
What it is
DESCRIPTION Polymyxin B for Injection, USP is one of a group of basic polypeptide antibiotics derived from B polymyxa (B aerosporous) . Polymyxin B sulfate is the sulfate salt of Polymyxins B 1 and B 2 , which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillacea).
Boxed warning
CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN. RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Macular degeneration | 176 | 201.1 174.8–231.4ROR 226.5 · χ² 34,343 / p <1e-300 | 194.0 EB05 171.1 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 142.5 · ♀ 100% (drug 59%) | no trial data cached |
| Respiratory tract infection | 165 | 85.8 74.2–99.2ROR 95.8 · χ² 13,671 / p <1e-300 | 84.4 EB05 74.2 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 69.5 · ♀ 99% (drug 59%) · 93% clinician | no trial data cached |
| Oedema | 186 | 46.3 40.4–52.9ROR 52.4 · χ² 8,182 / p <1e-300 | 45.9 EB05 40.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 38.6 · ♀ 98% (drug 59%) · 94% clinician | no trial data cached |
| Vaginal discharge | 33 | 44.2 31.5–62.0ROR 45.1 · χ² 1,347 / p 3e-295 | 43.1 EB05 32.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 100% (drug 59%) | no trial data cached |
| Paraesthesia oral | 46 | 43.1 32.4–57.3ROR 44.3 · χ² 1,844 / p <1e-300 | 42.2 EB05 33.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 50.0 · ♀ 95% (drug 59%) | no trial data cached |
| Oral candidiasis (oral thrush) | 36 | 37.2 26.9–51.4ROR 38.1 · χ² 1,230 / p 8e-270 | 36.5 EB05 27.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 33.7 · ♀ 91% (drug 59%) | no trial data cached |
| Wheezing | 157 | 35.7 30.8–41.4ROR 39.6 · χ² 5,261 / p <1e-300 | 35.5 EB05 31.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 99% (drug 59%) · 93% clinician | no trial data cached |
| Disseminated intravascular coagulation | 28 | 26.7 18.5–38.5ROR 27.1 · χ² 665 / p 6e-147 | 26.2 EB05 19.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 21% (drug 59%) · 96% clinician | no trial data cached |
| Asthma | 185 | 22.2 19.4–25.4ROR 25.0 · χ² 3,733 / p <1e-300 | 22.1 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 · ♀ 99% (drug 59%) · 91% clinician | no trial data cached |
| Drug resistance | 41 | 21.4 15.9–29.0ROR 22.0 · χ² 779 / p 1e-171 | 21.2 EB05 16.3 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · ♀ 29% (drug 59%) · 100% clinician | no trial data cached |
| Procedural pain | 40 | 19.4 14.3–26.4ROR 19.9 · χ² 681 / p 2e-150 | 19.2 EB05 14.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · ♀ 100% (drug 59%) | no trial data cached |
| Drug hypersensitivity | 250 | 17.3 15.4–19.4ROR 20.4 · χ² 3,852 / p <1e-300 | 17.2 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.1 · ♀ 95% (drug 59%) · 92% clinician | no trial data cached |
| Frequent bowel movements | 34 | 17.0 12.2–23.7ROR 17.3 · χ² 495 / p 5e-110 | 16.7 EB05 12.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · ♀ 100% (drug 59%) | no trial data cached |
| Thrombotic microangiopathy | 12 | 16.6 9.5–29.2ROR 16.8 · χ² 161 / p 4e-37 | 15.5 EB05 8.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Hepatic function abnormal | 39 | 14.1 10.4–19.3ROR 14.5 · χ² 463 / p 5e-103 | 13.9 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 95% clinician | no trial data cached |
| Cytomegalovirus infection | 17 | 13.7 8.6–22.0ROR 13.9 · χ² 188 / p 4e-43 | 12.8 EB05 7.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Nephropathy toxic | 11 | 13.3 7.4–23.9ROR 13.3 · χ² 113 / p 1e-26 | 11.6 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Chest pain | 180 | 13.0 11.4–14.9ROR 14.6 · χ² 2,002 / p <1e-300 | 13.0 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 99% (drug 59%) · 94% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 27 | 13.0 8.9–18.9ROR 13.2 · χ² 287 / p 1e-64 | 12.5 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · ♀ 38% (drug 59%) · 92% clinician | no trial data cached |
| Colitis | 35 | 12.5 9.0–17.3ROR 12.7 · χ² 358 / p 3e-80 | 12.1 EB05 8.8 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.9 · ♀ 97% (drug 59%) | no trial data cached |
| Neurotoxicity | 14 | 10.8 6.4–18.2ROR 10.9 · χ² 115 / p 4e-27 | 9.3 EB05 5.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.8 | no trial data cached |
| Rectal haemorrhage | 34 | 10.6 7.6–14.8ROR 10.8 · χ² 286 / p 2e-64 | 10.0 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 100% (drug 59%) | no trial data cached |
| Colitis ulcerative | 34 | 10.2 7.3–14.3ROR 10.4 · χ² 274 / p 6e-62 | 9.7 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · ♀ 100% (drug 59%) | no trial data cached |
| Acute respiratory distress syndrome | 13 | 9.9 5.7–17.0ROR 9.9 · χ² 95 / p 1e-22 | 8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Pneumonia (lung infection) | 231 | 9.6 8.5–10.8ROR 11.1 · χ² 1,796 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 · ♀ 82% (drug 59%) · 92% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 47 | 9.6 7.2–12.7ROR 9.8 · χ² 352 / p 7e-79 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 91% (drug 59%) | no trial data cached |
| Bacterial infection | 13 | 9.4 5.5–16.1ROR 9.5 · χ² 89 / p 2e-21 | 7.8 EB05 4.6 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.7 | no trial data cached |
| Haematochezia (blood in stool) | 36 | 8.8 6.3–12.1ROR 9.0 · χ² 241 / p 1e-54 | 8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 94% (drug 59%) | no trial data cached |
| Septic shock | 28 | 8.7 6.0–12.6ROR 8.8 · χ² 183 / p 4e-42 | 7.9 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 27% (drug 59%) | no trial data cached |
| Drug ineffective for unapproved indication | 36 | 8.7 6.3–12.0ROR 8.8 · χ² 237 / p 8e-54 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 32% (drug 59%) · 100% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 10 | 8.4 4.5–15.6ROR 8.5 · χ² 58 / p 1e-14 | 6.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Febrile neutropenia | 41 | 8.3 6.1–11.2ROR 8.5 · χ² 257 / p 4e-58 | 7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 38% (drug 59%) · 95% clinician | no trial data cached |
| Therapeutic product effect incomplete | 42 | 8.0 5.9–10.7ROR 8.2 · χ² 250 / p 1e-56 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · ♀ 100% (drug 59%) | no trial data cached |
| Bone marrow failure | 12 | 7.9 4.5–13.8ROR 7.9 · χ² 65 / p 3e-16 | 6.4 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Cough | 157 | 7.5 6.5–8.7ROR 8.3 · χ² 894 / p 9e-197 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 99% (drug 59%) · 92% clinician | no trial data cached |
| Malaise (feeling unwell) | 231 | 7.1 6.3–7.9ROR 8.1 · χ² 1,219 / p 2e-267 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 98% (drug 59%) | no trial data cached |
| Therapeutic product effect decreased | 22 | 6.7 4.4–10.1ROR 6.7 · χ² 100 / p 7e-24 | 5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 · ♀ 95% (drug 59%) · 91% clinician | no trial data cached |
| Treatment failure | 38 | 6.2 4.5–8.5ROR 6.3 · χ² 162 / p 3e-37 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · ♀ 33% (drug 59%) · 100% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 10 | 6.1 3.3–11.2ROR 6.1 · χ² 37 / p 5e-10 | 4.9 EB05 2.8 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Neutrophil count decreased | 18 | 6.0 3.8–9.4ROR 6.0 · χ² 70 / p 4e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 250 | 17.3 15.4–19.4ROR 20.4 · χ² 3,852 / p <1e-300 | 17.2 EB05 15.5 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.1 · ♀ 95% (drug 59%) · 92% clinician | no trial data cached |
| Malaise (feeling unwell) | 231 | 7.1 6.3–7.9ROR 8.1 · χ² 1,219 / p 2e-267 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 98% (drug 59%) | no trial data cached |
| Pneumonia (lung infection) | 231 | 9.6 8.5–10.8ROR 11.1 · χ² 1,796 / p <1e-300 | 9.5 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.6 · ♀ 82% (drug 59%) · 92% clinician | no trial data cached |
| Oedema | 186 | 46.3 40.4–52.9ROR 52.4 · χ² 8,182 / p <1e-300 | 45.9 EB05 40.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 38.6 · ♀ 98% (drug 59%) · 94% clinician | no trial data cached |
| Asthma | 185 | 22.2 19.4–25.4ROR 25.0 · χ² 3,733 / p <1e-300 | 22.1 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 · ♀ 99% (drug 59%) · 91% clinician | no trial data cached |
| Chest pain | 180 | 13.0 11.4–14.9ROR 14.6 · χ² 2,002 / p <1e-300 | 13.0 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 99% (drug 59%) · 94% clinician | no trial data cached |
| Macular degeneration | 176 | 201.1 174.8–231.4ROR 226.5 · χ² 34,343 / p <1e-300 | 194.0 EB05 171.1 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 142.5 · ♀ 100% (drug 59%) | no trial data cached |
| Respiratory tract infection | 165 | 85.8 74.2–99.2ROR 95.8 · χ² 13,671 / p <1e-300 | 84.4 EB05 74.2 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 69.5 · ♀ 99% (drug 59%) · 93% clinician | no trial data cached |
| Cough | 157 | 7.5 6.5–8.7ROR 8.3 · χ² 894 / p 9e-197 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 99% (drug 59%) · 92% clinician | no trial data cached |
| Wheezing | 157 | 35.7 30.8–41.4ROR 39.6 · χ² 5,261 / p <1e-300 | 35.5 EB05 31.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 99% (drug 59%) · 93% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 47 | 9.6 7.2–12.7ROR 9.8 · χ² 352 / p 7e-79 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 91% (drug 59%) | no trial data cached |
| Paraesthesia oral | 46 | 43.1 32.4–57.3ROR 44.3 · χ² 1,844 / p <1e-300 | 42.2 EB05 33.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 50.0 · ♀ 95% (drug 59%) | no trial data cached |
| Therapeutic product effect incomplete | 42 | 8.0 5.9–10.7ROR 8.2 · χ² 250 / p 1e-56 | 7.5 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 · ♀ 100% (drug 59%) | no trial data cached |
| Febrile neutropenia | 41 | 8.3 6.1–11.2ROR 8.5 · χ² 257 / p 4e-58 | 7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 38% (drug 59%) · 95% clinician | no trial data cached |
| Drug resistance | 41 | 21.4 15.9–29.0ROR 22.0 · χ² 779 / p 1e-171 | 21.2 EB05 16.3 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.3 · ♀ 29% (drug 59%) · 100% 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.
- Macular degeneration — n=176, PRR 201.1
- Oedema — n=186, PRR 46.3
- Vaginal discharge — n=33, PRR 44.2
- Oral candidiasis — n=36, PRR 37.2
- Wheezing — n=157, PRR 35.7
- Disseminated intravascular coagulation — n=28, PRR 26.7
- Asthma — n=185, PRR 22.2
- Procedural pain — n=40, PRR 19.4
- Frequent bowel movements — n=34, PRR 17.0
- Hepatic function abnormal — n=39, PRR 14.1
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 Polymyxin B?
In FDA FAERS, the most frequently co-reported reaction terms for Polymyxin B are drug hypersensitivity, malaise, pneumonia, oedema, asthma, chest pain. 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 Polymyxin B have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY, INTRAVENOUSLY AND/OR INTRATHECALLY, IT SHOULD BE GIVEN ONLY TO HOSPITALIZED PATIENTS, SO AS TO PROVIDE CONSTANT SUPERVISION BY A PHYSICIAN. RENAL FUNCTION SHOULD BE CAREFULLY DETERMINED AND PATIENTS WITH RENAL DAMAGE AND NITROGEN RETENTION SHOULD HAVE REDUCED DOSAGE.
Do FAERS signals prove that Polymyxin B 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 a974c557-e88f-451b-a1bd-d2c656be226e, effective 20250509; matched on
openfda.generic_name.exact:"POLYMYXIN B") - 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, 56 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.