Polymyxin B

FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval FDA-approved 97 applications
Randomized controlled trials 135 of 7,286 publications on PubMed
Registered clinical trials 79 19 active
Adverse event reports 8,170 5,166 classified as serious
  • Polymyxin B is an FDA-approved drug, marketed as Maxitrol, Neosporin, Lumi-sporyn, Casporyn, Neomycin, Bacitracin, Dexasporin, Oticair, Trimethoprim, Polymyxin (first approval: June 6, 1963).
  • PubMed lists 7,286 publications mentioning it, including 135 randomized controlled trials and 1,762 animal-only studies.
  • ClinicalTrials.gov lists 79 registered studies testing it (19 active).
  • FDA's adverse event system (FAERS) holds 8,170 reports mentioning it; 5,166 classified as serious. Reports do not prove causation.

Research topics

  • Anti-Bacterial Agents 96
  • Microbial Sensitivity Tests 54
  • Drug Resistance, Multiple, Bacterial 33
  • Bacterial Proteins 21
  • Drug Resistance, Bacterial 21
  • Klebsiella pneumoniae 17
  • Escherichia coli 14
  • Acinetobacter baumannii 13
  • Klebsiella Infections 13
  • Pseudomonas aeruginosa 13

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
ANDA060647 NEO-POLYCIN Approved, discontinued April 19, 1954 DOW PHARM
NDA050168 CORTISPORIN Approved, discontinued March 26, 1957 MONARCH PHARMS
NDA050201 OPHTHOCORT Approved, discontinued June 25, 1958 PARKEDALE
NDA050218 CORTISPORIN Approved, discontinued April 16, 1963 MONARCH PHARMS
NDA050081 POLY-PRED Approved, discontinued May 10, 1963 ALLERGAN
NDA050023 MAXITROL Approved, marketed June 6, 1963 HARROW EYE
NDA050065 MAXITROL Approved, marketed July 19, 1963 SANDOZ
ANDA060716 POLYMYXIN B SULFATE Approved, discontinued June 29, 1964 HIKMA
NDA050169 CORTISPORIN Approved, discontinued December 18, 1964 MONARCH PHARMS
NDA061015 TERRAMYCIN W/ POLYMYXIN B SULFATE Approved, discontinued July 8, 1965 CASPER PHARMA LLC
ANDA060707 NEOSPORIN G.U. IRRIGANT Approved, marketed June 28, 1966 MONARCH PHARMS
ANDA060582 NEOSPORIN Approved, discontinued July 3, 1968 MONARCH PHARMS
NDA050416 CORTISPORIN Approved, discontinued May 10, 1971 CASPER PHARMA LLC
NDA050417 LUMI-SPORYN Approved, marketed May 10, 1971 CASPER PHARMA LLC
ANDA061578 POLY-RX Approved, discontinued January 5, 1972 X GEN PHARMS
ANDA061606 PYOCIDIN Approved, discontinued October 11, 1972 FOREST LABS
NDA050344 STATROL Approved, discontinued March 12, 1974 ALCON
NDA050456 STATROL Approved, discontinued March 12, 1974 ALCON
ANDA061229 POLYSPORIN Approved, discontinued April 16, 1974 MONARCH PHARMS
NDA060613 CASPORYN HC Approved, marketed May 25, 1975 CASPER PHARMA LLC
NDA050479 CORTISPORIN Approved, discontinued December 9, 1975 MONARCH PHARMS
ANDA062036 AEROSPORIN Approved, discontinued November 13, 1980 GLAXOSMITHKLINE
ANDA060764 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Approved, discontinued January 22, 1981 PADAGIS US
ANDA062166 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE Approved, discontinued April 14, 1981 PADAGIS US
ANDA062302 OTOBIOTIC Approved, discontinued December 1, 1981 SCHERING
ANDA062423 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed August 25, 1983 SANDOZ
ANDA062341 MAXITROL Approved, marketed May 22, 1984 SANDOZ
ANDA062544 DEXACIDIN Approved, discontinued October 29, 1984 NOVARTIS
ANDA062339 STATROL Approved, discontinued November 30, 1984 ALCON
ANDA062566 DEXACIDIN Approved, discontinued February 22, 1985 NOVARTIS
ANDA062488 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed November 6, 1985 SANDOZ
ANDA062664 NEOMYCIN AND POLYMYXIN B SULFATE Approved, discontinued April 8, 1986 WATSON LABS
ANDA062721 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE Approved, discontinued November 17, 1986 ALCON PHARMS LTD
ANDA062822 PEDIOTIC Approved, discontinued September 29, 1987 MONARCH PHARMS
ANDA062874 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed May 11, 1988 SANDOZ
NDA050567 POLYTRIM Approved, discontinued October 20, 1988 ALLERGAN
ANDA062938 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE Approved, discontinued July 31, 1989 PADAGIS US
ANDA064063 NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE Approved, marketed July 25, 1994 BAUSCH AND LOMB INC
ANDA063000 POLYMYXIN B SULFATE Approved, discontinued September 30, 1994 PHARMOBEDIENT
ANDA064046 BACITRACIN ZINC AND POLYMYXIN B SULFATE Approved, marketed January 26, 1995 BAUSCH AND LOMB INC
ANDA064028 BACITRACIN ZINC AND POLYMYXIN B SULFATE Approved, discontinued January 30, 1995 SCIEGEN PHARMS
ANDA064135 DEXASPORIN Approved, marketed September 13, 1995 BAUSCH AND LOMB INC
ANDA064064 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Approved, marketed October 30, 1995 BAUSCH AND LOMB INC
ANDA064068 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Approved, marketed October 30, 1995 BAUSCH AND LOMB INC
ANDA064053 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed December 29, 1995 BAUSCH AND LOMB INC
ANDA064047 NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN Approved, marketed January 31, 1996 BAUSCH AND LOMB INC
ANDA064065 OTICAIR Approved, marketed August 28, 1996 BAUSCH AND LOMB INC
ANDA064120 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approved, marketed February 14, 1997 BAUSCH AND LOMB INC
ANDA064211 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approved, marketed April 13, 1998 SANDOZ
ANDA065006 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approved, marketed December 17, 1998 EPIC PHARMA LLC
ANDA065022 BACITRACIN ZINC AND POLYMYXIN B SULFATE Approved, discontinued February 27, 2002 PADAGIS US
ANDA065088 NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC Approved, discontinued February 6, 2004 SCIEGEN PHARMS
ANDA065187 NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN Approved, marketed October 28, 2005 SCIEGEN PHARMS
ANDA065216 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, discontinued October 31, 2005 SAPTALIS PHARMS
ANDA065106 NEOMYCIN AND POLYMYXIN B SULFATE Approved, marketed January 31, 2006 XGEN PHARMS
ANDA065108 NEOMYCIN AND POLYMYXIN B SULFATE Approved, marketed January 31, 2006 XGEN PHARMS
ANDA065219 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed May 1, 2006 SCIEGEN PHARMS
ANDA065372 POLYMYXIN B SULFATE Approved, marketed January 10, 2008 FRESENIUS KABI USA
ANDA090110 POLYMYXIN B SULFATE Approved, discontinued June 29, 2011 RISING
ANDA065213 NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE Approved, discontinued July 25, 2012 SCIEGEN PHARMS
ANDA202766 POLYMYXIN B SULFATE Approved, marketed January 15, 2014 XELLIA PHARMS APS
ANDA206589 POLYMYXIN B SULFATE Approved, marketed April 4, 2016 EUGIA PHARMA
ANDA207322 POLYMYXIN B SULFATE Approved, marketed April 14, 2016 GLAND
ANDA211572 TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE Approved, marketed August 5, 2024 SOMERSET THERAPS LLC
ANDA217735 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed September 30, 2025 AMNEAL
ANDA217803 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed October 29, 2025 AMNEAL
ANDA220938 NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Approved, marketed August 27, 2026 ORBICULAR PHARM TECH
ANDA060427 NEO-POLYCIN Approved, discontinued — DOW PHARM
ANDA060730 OTOCORT Approved, discontinued — WATSON LABS
ANDA060731 BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE Approved, discontinued — ALTANA
ANDA061009 TERRAMYCIN-POLYMYXIN Approved, discontinued — PFIZER
ANDA061048 MYCITRACIN Approved, discontinued — PHARMACIA AND UPJOHN
ANDA061816 OTOBIONE Approved, discontinued — SCHERING
ANDA061841 TERRAMYCIN W/ POLYMYXIN Approved, discontinued — PFIZER
ANDA062167 BACITRACIN-NEOMYCIN-POLYMYXIN Approved, discontinued — PHARMADERM
ANDA062381 NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE Approved, discontinued — PHARMAFAIR
ANDA062383 NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN Approved, discontinued — PHARMAFAIR
ANDA062386 BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE Approved, discontinued — PHARMAFAIR
ANDA062389 ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE Approved, discontinued — PHARMAFAIR
ANDA062394 NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE Approved, discontinued — PHARMAFAIR
ANDA062399 OTICAIR Approved, discontinued — PHARMAFAIR
ANDA062411 DEXASPORIN Approved, discontinued — PHARMAFAIR
ANDA062428 DEXASPORIN Approved, discontinued — PHARMAFAIR
ANDA062430 OCUMYCIN Approved, discontinued — PHARMAFAIR
ANDA062455 POLYMYXIN B SULFATE Approved, discontinued — PADDOCK LLC
ANDA062499 LANABIOTIC Approved, discontinued — COMBE
ANDA062521 OTOCORT Approved, discontinued — WATSON LABS
ANDA062617 NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE Approved, discontinued — PHARMAFAIR
ANDA062623 NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE Approved, discontinued — PHARMAFAIR
ANDA062788 NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN Approved, discontinued — WATSON LABS
ANDA062818 NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN Approved, discontinued — IPHARM
ANDA062833 BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE Approved, discontinued — NASKA
ANDA062849 BACITRACIN ZINC-POLYMYXIN B SULFATE Approved, discontinued — NASKA
NDA050167 POLYSPORIN Approved, discontinued — GLAXOSMITHKLINE
NDA050176 NEOSPORIN Approved, discontinued — GLAXOSMITHKLINE
NDA050203 CHLOROMYXIN Approved, discontinued — PARKE DAVIS
NDA050598 LANABIOTIC Approved, discontinued — COMBE

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 7,286
  • Human (MeSH) 3,193
  • Animal only 1,762
  • Clinical trials 197
  • Randomized controlled trials 135
  • Systematic reviews & meta-analyses 51
  • Case reports 313
  • Retracted 6

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
79
Active
19
With posted results
14

Conditions studied

  • Septic Shock 8
  • Sepsis 7
  • Endotoxemia 4
  • Bloodstream Infection 3
  • Polymyxin B 3
  • Blood-Brain Barrier 2
  • Bacterial Meningitis 2
  • Ventilator Associated Bacterial Pneumonia (VABP) 2
  • Hospital Acquired Bacterial Pneumonia (HABP) 2
  • Blood Stream Infection 2
  • Acinetobacter Baumannii-calcoaceticus Complex 2
  • Carbapenem-Resistant Enterobacteriaceae Infection 2
Study Status Phase Start
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
NCT07905235 Central South University
Not yet recruiting — October 30, 2026
Exploring the Combination of Intracalvariosseous and Intravenous Antibiotics for Moderate to Severe Bacterial Meningitis
NCT07826351 yilong Wang
Not yet recruiting N/A September 21, 2026
EAA-Guided AN69-oXiris and PMX-HP Therapy in Septic Patients
NCT07788144 Kyoung Moo Im
Enrolling by invitation N/A August 11, 2026
Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
NCT07431307 BioVersys AG
Not yet recruiting Phase 2 Jul 2026
Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis
NCT07495150 yilong Wang
Not yet recruiting N/A April 1, 2026
Sebum Metabolomics and Lipidomics for Clinical Applications
NCT07549828 National Taiwan University Hospital
Not yet recruiting N/A April 1, 2026
A Phase I Study Comparing the Safety, Pharmacokinetics and Renal Effects of VRP-034 and Marketed Polymyxin B in Healthy Volunteers
NCT07502144 Venus Remedies Limited
Not yet recruiting Phase 1 Apr 2026
Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex
NCT07326540 BioVersys SAS
Recruiting Phase 3 March 27, 2026
ASK0912 Versus Polymyxin B for Injection in Adults With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
NCT07759934 Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Recruiting Phase 2 March 25, 2026
A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers
NCT07580586 BioVersys SAS
Recruiting Phase 1 March 22, 2026
Show 40 more studies
Study Status Phase Start
Evaluation of Three Different Intra-canal Medicaments
NCT07892703 Minia University
Recruiting N/A December 16, 2025
A Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Polymyxin B and Colistin Methanesulfonate in Patients With Carbapenem-Resistant Gram-Negative Bacterial Infection
NCT06966284 TTY Biopharm
Recruiting — November 26, 2025
Optimising TREATment for Severe Gram-Negative Bacterial Infections
NCT07004049 National University of Singapore
Recruiting Phase 4 April 21, 2025
A Study on the Combination Therapy of Eravacycline for Treating Carbapenem-Resistant Acinetobacter Baumannii Pneumonia
NCT06670872 Peking University Third Hospital
Not yet recruiting — Oct 2024
Intraventricular Administration of Intracranial Infections Caused by (Carbapenem-resistant Gram-negative Bacilli)CRGNB
NCT06595979 Second Affiliated Hospital, Zhejiang University, School of Medicine
Recruiting — June 25, 2024
Different Methods of Aerosolized Polymyxin B Inhalation for Treating Carbapenem-Resistant Gram-Negative Bacterial Pneumonia.
NCT07086391 Fujian Medical University Union Hospital
Recruiting — February 1, 2023
Evaluating a Dropless Postoperative Regimen After Cataract Surgery in a Vulnerable, County-hospital Population
NCT05157113 University of California, San Francisco
Recruiting Phase 4 May 31, 2022
Efficacy and Safety of Hemoperfusion With Polymyxin B in Septic Shock Associated With Severe Endotoxemia in Cardiac Surgery Patients (РМХ vs SS)
NCT04920565 Petrovsky National Research Centre of Surgery
Recruiting N/A November 1, 2021
Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D
NCT03920007 Atsena Therapeutics Inc. Results posted
Active, not recruiting Phase 1, Phase 2 October 22, 2019
The Safety and Microbial Changes in the Use of Intranasal Neosporin®
NCT07698938 Hospital Universitario Dr. Jose E. Gonzalez
Completed N/A February 13, 2025
Comparison of Epithelial Lining Fluid and Blood Pharmacokinetics and Pharmacodynamics of Intravenous and Intravenous Plus Nebulized Polymyxin B in Multidrug Resistant Bacteria Ventilator-associated Pneumonia Patients
NCT06076603 Southeast University, China
Unknown status — July 1, 2023
PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB
NCT05685615 BioVersys AG
Completed Phase 2 April 20, 2023
Topical Antibacterial Agents for Prevention of COVID-19
NCT05449392 Yale University
Completed Phase 1 September 1, 2022
Retentive Strength of Denture Adhesives on Various RR Ridges
NCT05063422 Altamash Institute of Dental Medicine
Completed Phase 1 August 18, 2022
A Pharmacokinetic Study of Polymyxin B in Healthy Subjects and Subjects With Renal Insufficiency
NCT05359627 TTY Biopharm
Completed Phase 1 July 26, 2022
Dropless Pars Plana Vitrectomy Study
NCT05331664 Massachusetts Eye and Ear Infirmary
Completed Phase 4 July 25, 2022
Best Available Therapy With or Without Meropenem for Bloodstream Infections by Enterobacterales With High Level of Resistance to Carbapenems
NCT04876430 Hospital de Clinicas de Porto Alegre
Terminated Phase 2, Phase 3 May 4, 2021
Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria
NCT04839653 MEDSI Clinical Hospital 1, ICU
Unknown status N/A May 1, 2021
Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts
NCT04649541 MicuRx
Completed Phase 1 November 29, 2020
Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
NCT05386810 Sinovac Biotech Co., Ltd
Completed Phase 3 November 5, 2020
The Diagnostic and Prognostic Value of Presepsin in Sepsis
NCT06180265 University of Foggia
Completed N/A February 1, 2020
Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study
NCT03901807 Spectral Diagnostics (US) Inc.
Completed N/A January 9, 2020
Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
NCT03894046 Entasis Therapeutics Results posted
Completed Phase 3 September 5, 2019
Pharmacokinetics of Polymyxin B in Adult Patients With Cystic Fibrosis
NCT04335370 University of Michigan
Completed — January 9, 2019
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae
NCT03950544 Shanghai 10th People's Hospital
Unknown status Early phase 1 January 1, 2019
Tacrolimus for Malar Edema
NCT03715387 University of British Columbia
Unknown status Phase 2, Phase 3 October 10, 2018
Melatonin for Renal Protection in Patients Receiving Polymyxin B
NCT03725267 Hospital de Clinicas de Porto Alegre
Terminated Phase 2 October 1, 2018
Efficacy Analysis of Tigecycline-based Therapy and Polymyxin B-based Therapy in ICU Infection
NCT04970537 Xiangya Hospital of Central South University
Unknown status — July 23, 2017
Polymyxin B Monotherapy vs Combination Therapy in Critically Ill Patients With Multi-drug Resistant Pathogens
NCT03159078 University of Puerto Rico
Unknown status Phase 3 May 25, 2017
Safety and Efficacy of Heparin Dosing Score Protocol for Polymyxin-B Hemoperfusion
NCT03177330 National Taiwan University Hospital
Unknown status — May 15, 2017
Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma
NCT02792036 St. Jude Children's Research Hospital
Completed Phase 1 November 1, 2016
Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection
NCT02871024 National Taiwan University Hospital
Terminated N/A Aug 2016
Gut Decontamination In Pediatric Allogeneic Hematopoietic
NCT02641236 Dana-Farber Cancer Institute Results posted
Completed Phase 2 Mar 2016
Optimizing Clinical Use of Polymyxin B
NCT02682355 Rutgers, The State University of New Jersey
Completed — Feb 2016
A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
NCT02582255 Fidec Corporation Results posted
Completed Phase 4 Nov 2015
Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis
NCT02515656 Laboratoire Innotech International Results posted
Completed Phase 3 Sep 2015
Heparin for the Treatment of Burn Wound Pain
NCT02497326 King Edward Medical University
Unknown status N/A Apr 2015
Trial to Test if Antibiotic Ointments & Cream Will Sting After Application on a Minor Wound After Tape Stripping Injury
NCT02320695 Johnson & Johnson Consumer and Personal Products Worldwide Results posted
Completed N/A Mar 2015
The Pilot Study of the Efficacy of Polymyxin-B Hemoperfusion in Critically Ill Patients With Severe Sepsis
NCT02413541 Chulalongkorn University
Completed N/A Jan 2015
Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria
NCT02134106 Tan Tock Seng Hospital
Withdrawn Phase 2, Phase 3 Jan 2015

All 79 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
8,170
Serious
5,166
With death outcome
728

Most reported reactions

  • Drug ineffective 1,192
  • Pain 723
  • Macular degeneration 646
  • Malaise 600
  • Off label use 585
  • Nausea 533
  • Drug hypersensitivity 460
  • Headache 460
  • Pyrexia 458
  • Dyspnoea 427
  • Pneumonia 426
  • Vomiting 412

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Boxed warning Polymyxin B · June 22, 2026
Original FDA text (English) WARNING CAUTION: WHEN THIS DRUG IS GIVEN INTRAMUSCULARLY 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. PATIENTS WITH NEPHROTOXICITY DUE TO POLYMYXIN B SULFATE USUALLY SHOW ALBUMINURIA, CELLULAR CASTS, AND AZOTEMIA. DIMINISHING URINE OUTPUT AND A RISING BUN ARE INDICATIONS FOR DISCONTINUING THERAPY WITH THIS DRUG. NEUROTOXIC REACTIONS MAY BE MANIFESTED BY IRRITABILITY, WEAKNESS, DROWSINESS, ATAXIA, PERIORAL PARESTHESIA, NUMBNESS OF THE EXTREMITIES, AND BLURRING OF VISION. THESE ARE USUALLY ASSOCIATED WITH HIGH SERUM LEVELS FOUND IN PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR NEPHROTOXICITY. THE CONCURRENT OR SEQUENTIAL USE OF OTHER NEUROTOXIC AND/OR NEPHROTOXIC DRUGS WITH POLYMYXIN B SULFATE, PARTICULARLY BACITRACIN, STREPTOMYCIN, NEOMYCIN, KANAMYCIN, GENTAMICIN, TOBRAMYCIN, AMIKACIN, CEPHALORIDINE, PAROMOMYCIN, VIOMYCIN, AND COLISTIN SHOULD BE AVOIDED. THE NEUROTOXICITY OF POLYMYXIN B SULFATE CAN RESULT IN RESPIRATORY PARALYSIS FROM NEUROMUSCULAR BLOCKADE, ESPECIALLY WHEN THE DRUG IS GIVEN SOON AFTER ANESTHESIA AND/OR MUSCLE RELAXANTS. USAGE IN PREGNANCY: THE SAFETY OF THIS DRUG IN HUMAN PREGNANCY HAS NOT BEEN ESTABLISHED.

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.