PITOFENONE: 20 Adverse Event Reports & Safety Profile
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20
Total FAERS Reports
2 (10.0%)
Deaths Reported
16
Hospitalizations
20
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
First Report: 20200601 · Latest Report: 20250524
What Are the Most Common PITOFENONE Side Effects?
#1 Most Reported
Pyrexia
12 reports (60.0%)
#2 Most Reported
Productive cough
12 reports (60.0%)
#3 Most Reported
Musculoskeletal chest pain
12 reports (60.0%)
All PITOFENONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Balance disorder | 12 | 60.0% | 0 | 11 |
| Cerebrovascular accident | 12 | 60.0% | 0 | 11 |
| Chromaturia | 12 | 60.0% | 0 | 11 |
| Confusional state | 12 | 60.0% | 0 | 11 |
| Decreased appetite | 12 | 60.0% | 0 | 11 |
| Fall | 12 | 60.0% | 0 | 11 |
| Feeling cold | 12 | 60.0% | 0 | 11 |
| Gait disturbance | 12 | 60.0% | 0 | 11 |
| Hypoaesthesia | 12 | 60.0% | 0 | 11 |
| Inappropriate schedule of product administration | 12 | 60.0% | 0 | 11 |
| Limb discomfort | 12 | 60.0% | 0 | 11 |
| Malaise | 12 | 60.0% | 0 | 11 |
| Musculoskeletal chest pain | 12 | 60.0% | 0 | 11 |
| Productive cough | 12 | 60.0% | 0 | 11 |
| Pyrexia | 12 | 60.0% | 0 | 11 |
| Neutrophil count abnormal | 11 | 55.0% | 0 | 10 |
Who Reports PITOFENONE Side Effects? Age & Gender Data
Gender: 40.0% female, 60.0% male. Average age: 67.3 years. Most reports from: GB. View detailed demographics →
Is PITOFENONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2020 | 1 | 0 | 1 |
| 2022 | 1 | 0 | 1 |
| 2023 | 1 | 0 | 0 |
| 2025 | 1 | 1 | 0 |
What Is PITOFENONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 18 |
Official FDA Label for PITOFENONE
Official prescribing information from the FDA-approved drug label.