DEXIBUPROFEN: 61 Adverse Event Reports & Safety Profile
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61
Total FAERS Reports
2 (3.3%)
Deaths Reported
21
Hospitalizations
61
As Primary/Secondary Suspect
1
Disabilities
First Report: 20131209 · Latest Report: 20240511
What Are the Most Common DEXIBUPROFEN Side Effects?
#1 Most Reported
Dyspnoea
18 reports (29.5%)
#2 Most Reported
Sopor
16 reports (26.2%)
#3 Most Reported
Drug abuse
12 reports (19.7%)
All DEXIBUPROFEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 18 | 29.5% | 0 | 1 |
| Sopor | 16 | 26.2% | 0 | 8 |
| Drug abuse | 12 | 19.7% | 0 | 4 |
| Headache | 8 | 13.1% | 0 | 1 |
| Drug hypersensitivity | 7 | 11.5% | 0 | 1 |
| Fatigue | 7 | 11.5% | 0 | 0 |
| Myalgia | 7 | 11.5% | 0 | 0 |
| Renal pain | 7 | 11.5% | 0 | 0 |
| Tendon pain | 7 | 11.5% | 0 | 0 |
| Abdominal pain upper | 5 | 8.2% | 0 | 3 |
| Acute kidney injury | 5 | 8.2% | 1 | 2 |
| Urticaria | 5 | 8.2% | 0 | 0 |
Who Reports DEXIBUPROFEN Side Effects? Age & Gender Data
Gender: 75.4% female, 24.6% male. Average age: 45.0 years. Most reports from: IT. View detailed demographics →
Is DEXIBUPROFEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 1 |
| 2016 | 1 | 0 | 1 |
| 2017 | 4 | 0 | 1 |
| 2018 | 4 | 0 | 2 |
| 2019 | 17 | 0 | 9 |
| 2022 | 1 | 0 | 0 |
| 2023 | 3 | 0 | 1 |
| 2024 | 1 | 0 | 0 |
What Is DEXIBUPROFEN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 16 |
| Pain | 11 |
| Antiinflammatory therapy | 7 |
Official FDA Label for DEXIBUPROFEN
Official prescribing information from the FDA-approved drug label.