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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.

POLYSORBATE 20: 59 Adverse Event Reports & Safety Profile

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59
Total FAERS Reports
0
Deaths Reported
55
Hospitalizations
59
As Primary/Secondary Suspect
42
Life-Threatening
2
Disabilities

First Report: 20180226 · Latest Report: 20230201

What Are the Most Common POLYSORBATE 20 Side Effects?

#1 Most Reported
Fall
47 reports (79.7%)
#2 Most Reported
Cognitive disorder
47 reports (79.7%)
#3 Most Reported
Pain
46 reports (78.0%)

All POLYSORBATE 20 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cognitive disorder 47 79.7% 0 47
Fall 47 79.7% 0 47
Balance disorder 46 78.0% 0 46
Blood calcium decreased 46 78.0% 0 46
Constipation 46 78.0% 0 46
Creatinine renal clearance decreased 46 78.0% 0 46
Depressed level of consciousness 46 78.0% 0 46
Hypotension 46 78.0% 0 46
Mobility decreased 46 78.0% 0 46
Orthostatic hypotension 46 78.0% 0 46
Pain 46 78.0% 0 46
Sedation complication 41 69.5% 0 41
Sedation 40 67.8% 0 40
Toxicity to various agents 40 67.8% 0 40
Drug interaction 34 57.6% 0 34
Dyspnoea 34 57.6% 0 34
Renal function test abnormal 34 57.6% 0 34
Drug abuse 31 52.5% 0 31
Overdose 31 52.5% 0 31
Off label use 30 50.9% 0 30

Who Reports POLYSORBATE 20 Side Effects? Age & Gender Data

Gender: 96.2% female, 3.8% male. Average age: 75.8 years. Most reports from: CA. View detailed demographics →

Is POLYSORBATE 20 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2018 1 0 1
2023 1 0 0

View full timeline →

What Is POLYSORBATE 20 Used For?

IndicationReports
Insomnia 49
Product used for unknown indication 9

Official FDA Label for POLYSORBATE 20

Official prescribing information from the FDA-approved drug label.