PILSICAINIDE: 84 Adverse Event Reports & Safety Profile
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84
Total FAERS Reports
6 (7.1%)
Deaths Reported
48
Hospitalizations
84
As Primary/Secondary Suspect
7
Life-Threatening
1
Disabilities
Active Ingredient: PILSICAINIDE HYDROCHLORIDE ·
First Report: 20091226 · Latest Report: 20250101
What Are the Most Common PILSICAINIDE Side Effects?
#1 Most Reported
Bradycardia
11 reports (13.1%)
#2 Most Reported
Renal impairment
8 reports (9.5%)
#3 Most Reported
Atrial fibrillation
8 reports (9.5%)
All PILSICAINIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Bradycardia | 11 | 13.1% | 0 | 7 |
| Atrial fibrillation | 8 | 9.5% | 0 | 7 |
| Renal impairment | 8 | 9.5% | 0 | 8 |
| Dizziness | 7 | 8.3% | 0 | 5 |
| Electrocardiogram qt prolonged | 7 | 8.3% | 0 | 4 |
| Toxicity to various agents | 6 | 7.1% | 2 | 5 |
| Blood pressure decreased | 5 | 6.0% | 0 | 4 |
| Cardiac failure | 5 | 6.0% | 1 | 2 |
| Decreased appetite | 5 | 6.0% | 0 | 5 |
| Depressed level of consciousness | 5 | 6.0% | 0 | 5 |
| Drug interaction | 5 | 6.0% | 1 | 0 |
| Hyperkalaemia | 5 | 6.0% | 0 | 5 |
| Off label use | 5 | 6.0% | 0 | 4 |
Who Reports PILSICAINIDE Side Effects? Age & Gender Data
Gender: 43.0% female, 57.0% male. Average age: 71.8 years. Most reports from: JP. View detailed demographics →
Is PILSICAINIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2012 | 1 | 0 | 1 |
| 2013 | 2 | 0 | 1 |
| 2014 | 2 | 0 | 2 |
| 2015 | 9 | 0 | 3 |
| 2016 | 7 | 0 | 6 |
| 2017 | 3 | 1 | 1 |
| 2018 | 4 | 0 | 2 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 4 | 2 | 3 |
| 2022 | 1 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is PILSICAINIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 25 |
| Atrial fibrillation | 18 |
| Arrhythmia | 10 |
Official FDA Label for PILSICAINIDE
Official prescribing information from the FDA-approved drug label.