NALOXEGOL: 63 Adverse Event Reports & Safety Profile
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63
Total FAERS Reports
13 (20.6%)
Deaths Reported
28
Hospitalizations
63
As Primary/Secondary Suspect
4
Life-Threatening
None
Status
FDA Application: 212625 ·
First Report: 2013 · Latest Report: 20240701
What Are the Most Common NALOXEGOL Side Effects?
#1 Most Reported
Constipation
12 reports (19.0%)
#2 Most Reported
Pain
9 reports (14.3%)
#3 Most Reported
Diarrhoea
7 reports (11.1%)
All NALOXEGOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Constipation | 12 | 19.1% | 0 | 5 |
| Pain | 9 | 14.3% | 2 | 1 |
| Diarrhoea | 7 | 11.1% | 1 | 4 |
| Abdominal pain | 6 | 9.5% | 0 | 2 |
| Anxiety | 6 | 9.5% | 0 | 1 |
| Disease progression | 6 | 9.5% | 6 | 1 |
| Intestinal perforation | 6 | 9.5% | 6 | 0 |
| Vomiting | 6 | 9.5% | 0 | 3 |
| Drug ineffective | 5 | 7.9% | 1 | 2 |
| Nausea | 5 | 7.9% | 0 | 3 |
| Sepsis | 5 | 7.9% | 5 | 0 |
Who Reports NALOXEGOL Side Effects? Age & Gender Data
Gender: 50.0% female, 50.0% male. Average age: 61.0 years. Most reports from: FR. View detailed demographics →
Is NALOXEGOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 4 | 0 | 0 |
| 2015 | 2 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2017 | 7 | 2 | 2 |
| 2018 | 9 | 3 | 6 |
| 2019 | 11 | 5 | 5 |
| 2020 | 3 | 1 | 2 |
| 2021 | 2 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 3 | 0 | 2 |
| 2024 | 1 | 0 | 0 |
What Is NALOXEGOL Used For?
| Indication | Reports |
|---|---|
| Constipation | 43 |
| Product used for unknown indication | 10 |
Official FDA Label for NALOXEGOL
Official prescribing information from the FDA-approved drug label.