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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

POLIHEXANIDE: 66 Adverse Event Reports & Safety Profile

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66
Total FAERS Reports
1 (1.5%)
Deaths Reported
15
Hospitalizations
66
As Primary/Secondary Suspect
Shenzhen Shierjie Biologica...
Manufacturer

Active Ingredient: POLIHEXANIDE HYDROCHLORIDE · Route: TOPICAL · Manufacturer: Shenzhen Shierjie Biological Engineering Co., LTD · HUMAN OTC DRUG · FDA Label: Available

First Report: 20190726 · Latest Report: 20230901

What Are the Most Common POLIHEXANIDE Side Effects?

#1 Most Reported
Drug ineffective
29 reports (43.9%)
#2 Most Reported
Drug ineffective for unapproved indication
18 reports (27.3%)
#3 Most Reported
Off label use
16 reports (24.2%)

All POLIHEXANIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 29 43.9% 0 3
Drug ineffective for unapproved indication 18 27.3% 0 10
Off label use 16 24.2% 1 6
Condition aggravated 11 16.7% 1 7
Acanthamoeba keratitis 8 12.1% 0 6
Adverse drug reaction 6 9.1% 0 6
Product use in unapproved indication 6 9.1% 0 2
Myopathy 5 7.6% 0 0

Who Reports POLIHEXANIDE Side Effects? Age & Gender Data

Gender: 39.4% female, 60.6% male. Average age: 47.3 years. Most reports from: US. View detailed demographics →

Is POLIHEXANIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 1 0 1
2021 1 0 0
2023 2 0 0

View full timeline →

What Is POLIHEXANIDE Used For?

IndicationReports
Acanthamoeba keratitis 43
Serratia infection 6
Pseudomonas infection 5
Ulcerative keratitis 5

Official FDA Label for POLIHEXANIDE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Use For underarm, privates, and beyond cleansing to help reduce odor and rfesh skin. For use when showering or changing clothes is not available.

Dosage & Administration

Directions 1.Open the resealable label. 2.Pull out one deodorant wipe. 3.Wipe on body as needed to remove sweat and dirt. 4.Reseal pack when finished.

Warnings

Warnings

  • Keep away from fire or flame, heat and spark.
  • For external use only.

Active Ingredient

Active Ingredient Polihexanide Hydrochloride 0.1 5%(W/W)

Inactive Ingredients

Inactive ingredients Aqua, Propylene Glycol, 1,2-Hexanediol, Polysorbate 20, Tussilago Farfara Extract, Centella Asiatica Extract