PHENOXYETHANOL: 63 Adverse Event Reports & Safety Profile

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Total FAERS Reports

61 (96.8%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

SHENZHEN BENLIJU BIO-TECH C...

Manufacturer

Route: TOPICAL · Manufacturer: SHENZHEN BENLIJU BIO-TECH CO.,LTD · HUMAN OTC DRUG · FDA Label: Available

First Report: 201603 · Latest Report: 20210605

What Are the Most Common PHENOXYETHANOL Side Effects?

#1 Most Reported

Abdominal distension

38 reports (60.3%)

#2 Most Reported

Vomiting

37 reports (58.7%)

#3 Most Reported

Somnolence

35 reports (55.6%)

All PHENOXYETHANOL Side Effects by Frequency

Side Effect	Reports	% of Total	Deaths	Hosp.
Abdominal distension	38	60.3%	38	33
Vomiting	37	58.7%	37	32
Abdominal pain	35	55.6%	35	30
Appendicitis	35	55.6%	35	30
Ascites	35	55.6%	35	30
Condition aggravated	35	55.6%	35	30
Somnolence	35	55.6%	35	30
Appendicolith	34	54.0%	34	29
Dry mouth	34	54.0%	34	29
Hyponatraemia	34	54.0%	34	29
Off label use	34	54.0%	34	29
Ventricular fibrillation	34	54.0%	34	29
Blood cholesterol increased	33	52.4%	33	31
Blood phosphorus increased	33	52.4%	33	28
Blood uric acid increased	33	52.4%	33	31
Constipation	33	52.4%	33	28
Diabetes mellitus	33	52.4%	33	31
General physical health deterioration	33	52.4%	33	28
Nausea	33	52.4%	33	28
Stress	33	52.4%	33	28

Who Reports PHENOXYETHANOL Side Effects? Age & Gender Data

Gender: 1.2% female, 98.8% male. Average age: 79.0 years. Most reports from: CA. View detailed demographics →

Is PHENOXYETHANOL Getting Safer? Reports by Year

Year	Reports	Deaths	Hosp.
2016	1	0	0
2020	24	24	23
2021	1	1	1

View full timeline →

What Is PHENOXYETHANOL Used For?

Indication	Reports
Constipation	60

Official FDA Label for PHENOXYETHANOL

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses CPAP WIPES to help to clean and reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage & Administration

Directions Wipe your CPAP Mask after each use and discard the wipe after cleaning. Let CPAP mask air dry. Keep cover closed in between uses to prevent drying. If irritation occurs discontinue use and seek medical advice. Store in a cool dry place.

Warnings

Warnings For external use only.

Active Ingredient

Active Ingredient Phenoxyethanol 0.3%

Inactive Ingredients

Inactive ingredients DMDMH, Water (Aqua)