OTERACIL: 80 Adverse Event Reports & Safety Profile
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80
Total FAERS Reports
20 (25.0%)
Deaths Reported
26
Hospitalizations
80
As Primary/Secondary Suspect
4
Life-Threatening
Active Ingredient: OTERACIL POTASSIUM ·
First Report: 20130327 · Latest Report: 20220829
What Are the Most Common OTERACIL Side Effects?
#1 Most Reported
Disease progression
17 reports (21.3%)
#2 Most Reported
Decreased appetite
11 reports (13.8%)
#3 Most Reported
Diarrhoea
10 reports (12.5%)
All OTERACIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disease progression | 17 | 21.3% | 4 | 2 |
| Decreased appetite | 11 | 13.8% | 2 | 5 |
| Diarrhoea | 10 | 12.5% | 1 | 5 |
| Anaemia | 8 | 10.0% | 0 | 1 |
| Myelosuppression | 8 | 10.0% | 1 | 1 |
| Nausea | 7 | 8.8% | 0 | 2 |
| Thrombocytopenia | 7 | 8.8% | 1 | 2 |
| Vomiting | 7 | 8.8% | 0 | 0 |
| Drug ineffective | 6 | 7.5% | 1 | 1 |
| Neutropenia | 6 | 7.5% | 0 | 0 |
| Bone marrow failure | 5 | 6.3% | 0 | 3 |
| Fatigue | 5 | 6.3% | 1 | 1 |
Who Reports OTERACIL Side Effects? Age & Gender Data
Gender: 38.9% female, 61.1% male. Average age: 62.6 years. Most reports from: JP. View detailed demographics →
Is OTERACIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 1 | 0 |
| 2017 | 3 | 0 | 1 |
| 2018 | 2 | 0 | 1 |
| 2019 | 3 | 0 | 2 |
| 2020 | 1 | 1 | 0 |
| 2021 | 4 | 0 | 1 |
| 2022 | 1 | 0 | 1 |
What Is OTERACIL Used For?
| Indication | Reports |
|---|---|
| Gastric cancer | 23 |
| Chemotherapy | 7 |
Official FDA Label for OTERACIL
Official prescribing information from the FDA-approved drug label.