FOSPHENYTOIN\FOSPHENYTOIN: 82 Adverse Event Reports & Safety Profile
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82
Total FAERS Reports
18 (22.0%)
Deaths Reported
28
Hospitalizations
82
As Primary/Secondary Suspect
15
Life-Threatening
2
Disabilities
Active Ingredient: FOSPHENYTOIN\FOSPHENYTOIN SODIUM ·
First Report: 20120523 · Latest Report: 20180302
What Are the Most Common FOSPHENYTOIN\FOSPHENYTOIN Side Effects?
#1 Most Reported
Cardiac arrest
10 reports (12.2%)
#2 Most Reported
Seizure
9 reports (11.0%)
#3 Most Reported
Bradycardia
7 reports (8.5%)
All FOSPHENYTOIN\FOSPHENYTOIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cardiac arrest | 10 | 12.2% | 6 | 2 |
| Seizure | 9 | 11.0% | 6 | 4 |
| Bradycardia | 7 | 8.5% | 4 | 3 |
| Drug ineffective | 6 | 7.3% | 0 | 2 |
| Hypotension | 6 | 7.3% | 4 | 3 |
| Coma | 5 | 6.1% | 4 | 3 |
Who Reports FOSPHENYTOIN\FOSPHENYTOIN Side Effects? Age & Gender Data
Gender: 48.5% female, 51.5% male. Average age: 36.6 years. Most reports from: US. View detailed demographics →
Is FOSPHENYTOIN\FOSPHENYTOIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2014 | 6 | 1 | 2 |
| 2015 | 5 | 1 | 4 |
| 2016 | 4 | 2 | 0 |
| 2017 | 1 | 1 | 0 |
| 2018 | 1 | 0 | 0 |
What Is FOSPHENYTOIN\FOSPHENYTOIN Used For?
| Indication | Reports |
|---|---|
| Seizure | 21 |
| Generalised tonic-clonic seizure | 10 |
| Product used for unknown indication | 10 |
| Convulsion prophylaxis | 8 |
| Status epilepticus | 8 |
| Epilepsy | 6 |
| Convulsion | 5 |
Official FDA Label for FOSPHENYTOIN\FOSPHENYTOIN
Official prescribing information from the FDA-approved drug label.