POLYSORBATE 80: 73 Adverse Event Reports & Safety Profile
Wake Up Pain-Free — Sleep Like Never Before
Derila Ergo Pillow: ergonomic design, cooling tech. 75% OFF today.
73
Total FAERS Reports
2 (2.7%)
Deaths Reported
41
Hospitalizations
73
As Primary/Secondary Suspect
35
Life-Threatening
2
Disabilities
First Report: 2014 · Latest Report: 20230201
What Are the Most Common POLYSORBATE 80 Side Effects?
#1 Most Reported
Dyspnoea
32 reports (43.8%)
#2 Most Reported
Sedation complication
30 reports (41.1%)
#3 Most Reported
Pain
30 reports (41.1%)
All POLYSORBATE 80 Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 32 | 43.8% | 0 | 29 |
| Fall | 30 | 41.1% | 0 | 29 |
| Pain | 30 | 41.1% | 0 | 29 |
| Sedation complication | 30 | 41.1% | 0 | 30 |
| Balance disorder | 29 | 39.7% | 0 | 29 |
| Blood calcium decreased | 29 | 39.7% | 0 | 29 |
| Cognitive disorder | 29 | 39.7% | 0 | 29 |
| Constipation | 29 | 39.7% | 0 | 29 |
| Creatinine renal clearance decreased | 29 | 39.7% | 0 | 29 |
| Depressed level of consciousness | 29 | 39.7% | 0 | 29 |
| Hypotension | 29 | 39.7% | 0 | 29 |
| Mobility decreased | 29 | 39.7% | 0 | 29 |
| Orthostatic hypotension | 29 | 39.7% | 0 | 29 |
| Sedation | 29 | 39.7% | 0 | 29 |
| Toxicity to various agents | 29 | 39.7% | 0 | 29 |
| Drug interaction | 28 | 38.4% | 0 | 28 |
| Renal function test abnormal | 28 | 38.4% | 0 | 28 |
| Off label use | 26 | 35.6% | 0 | 24 |
| Drug abuse | 25 | 34.3% | 0 | 25 |
| Creatinine renal clearance increased | 24 | 32.9% | 0 | 24 |
Who Reports POLYSORBATE 80 Side Effects? Age & Gender Data
Gender: 74.2% female, 25.8% male. Average age: 64.8 years. Most reports from: CA. View detailed demographics →
Is POLYSORBATE 80 Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2015 | 1 | 1 | 1 |
| 2016 | 2 | 0 | 1 |
| 2017 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2021 | 2 | 0 | 1 |
| 2023 | 1 | 0 | 0 |
What Is POLYSORBATE 80 Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 28 |
| Insomnia | 26 |
Official FDA Label for POLYSORBATE 80
Official prescribing information from the FDA-approved drug label.