PEMOLINE: 30 Adverse Event Reports & Safety Profile
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30
Total FAERS Reports
14 (46.7%)
Deaths Reported
2
Hospitalizations
30
As Primary/Secondary Suspect
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available
FDA Application: 016832 ·
First Report: 201508 · Latest Report: 20180227
What Are the Most Common PEMOLINE Side Effects?
#1 Most Reported
Toxicity to various agents
13 reports (43.3%)
#2 Most Reported
Drug abuse
13 reports (43.3%)
#3 Most Reported
Psychotic disorder
5 reports (16.7%)
All PEMOLINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 13 | 43.3% | 13 | 0 |
| Toxicity to various agents | 13 | 43.3% | 13 | 0 |
| Overdose | 5 | 16.7% | 5 | 0 |
| Psychotic disorder | 5 | 16.7% | 0 | 1 |
Who Reports PEMOLINE Side Effects? Age & Gender Data
Gender: 78.3% female, 21.7% male. Average age: 34.2 years. Most reports from: JP. View detailed demographics →
Is PEMOLINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2015 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
What Is PEMOLINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 18 |
| Narcolepsy | 6 |
Official FDA Label for PEMOLINE
Official prescribing information from the FDA-approved drug label.