ETHOTOIN: 11 Adverse Event Reports & Safety Profile
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11
Total FAERS Reports
1 (9.1%)
Deaths Reported
3
Hospitalizations
11
As Primary/Secondary Suspect
1
Life-Threatening
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 010841 ·
First Report: 2009 · Latest Report: 20210207
What Are the Most Common ETHOTOIN Side Effects?
#1 Most Reported
Product availability issue
3 reports (27.3%)
#2 Most Reported
Speech disorder developmental
2 reports (18.2%)
#3 Most Reported
Somnolence
2 reports (18.2%)
All ETHOTOIN Side Effects by Frequency
No side effect data available.
Who Reports ETHOTOIN Side Effects? Age & Gender Data
Gender: 70.0% female, 30.0% male. Average age: 71.0 years. Most reports from: US. View detailed demographics →
Is ETHOTOIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 1 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 1 |
What Is ETHOTOIN Used For?
| Indication | Reports |
|---|---|
| Seizure | 5 |
Official FDA Label for ETHOTOIN
Official prescribing information from the FDA-approved drug label.