INDOBUFEN: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
0
Deaths Reported
26
Hospitalizations
52
As Primary/Secondary Suspect
2
Life-Threatening
13
Disabilities
First Report: 201710 · Latest Report: 20250809
What Are the Most Common INDOBUFEN Side Effects?
#1 Most Reported
Asthenia
11 reports (21.2%)
#2 Most Reported
Melaena
10 reports (19.2%)
#3 Most Reported
Upper gastrointestinal haemorrhage
9 reports (17.3%)
All INDOBUFEN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Asthenia | 11 | 21.2% | 0 | 9 |
| Melaena | 10 | 19.2% | 0 | 9 |
| Faeces discoloured | 9 | 17.3% | 0 | 6 |
| Skin ulcer | 9 | 17.3% | 0 | 0 |
| Upper gastrointestinal haemorrhage | 9 | 17.3% | 0 | 7 |
| Anaemia | 7 | 13.5% | 0 | 7 |
| Dizziness | 7 | 13.5% | 0 | 5 |
| Gastrointestinal haemorrhage | 7 | 13.5% | 0 | 5 |
| Chest discomfort | 6 | 11.5% | 0 | 6 |
Who Reports INDOBUFEN Side Effects? Age & Gender Data
Gender: 34.5% female, 65.5% male. Average age: 70.5 years. Most reports from: CN. View detailed demographics →
Is INDOBUFEN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2017 | 13 | 0 | 0 |
| 2020 | 1 | 0 | 1 |
| 2021 | 1 | 0 | 0 |
| 2022 | 3 | 0 | 3 |
| 2023 | 12 | 0 | 9 |
| 2024 | 8 | 0 | 6 |
| 2025 | 5 | 0 | 5 |
What Is INDOBUFEN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 14 |
| Coronary artery disease | 7 |
| Antiplatelet therapy | 6 |
Official FDA Label for INDOBUFEN
Official prescribing information from the FDA-approved drug label.