LAMOTRIGIN: 40 Adverse Event Reports & Safety Profile
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40
Total FAERS Reports
1 (2.5%)
Deaths Reported
4
Hospitalizations
40
As Primary/Secondary Suspect
1
Life-Threatening
First Report: 2009 · Latest Report: 201404
What Are the Most Common LAMOTRIGIN Side Effects?
#1 Most Reported
Foetal exposure during pregnancy
12 reports (30.0%)
#2 Most Reported
Exposure during pregnancy
11 reports (27.5%)
#3 Most Reported
Neonatal respiratory distress syndrome
8 reports (20.0%)
All LAMOTRIGIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Foetal exposure during pregnancy | 12 | 30.0% | 0 | 2 |
| Exposure during pregnancy | 11 | 27.5% | 0 | 0 |
| Atrial septal defect | 8 | 20.0% | 0 | 0 |
| Neonatal respiratory distress syndrome | 8 | 20.0% | 0 | 1 |
| Ventricular septal defect | 7 | 17.5% | 0 | 0 |
| Feeding disorder neonatal | 5 | 12.5% | 0 | 2 |
Who Reports LAMOTRIGIN Side Effects? Age & Gender Data
Average age: 11.8 years. Most reports from: DE. View detailed demographics →
Is LAMOTRIGIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 2 | 0 | 0 |
| 2012 | 12 | 0 | 1 |
| 2013 | 13 | 0 | 2 |
| 2014 | 2 | 0 | 0 |
What Is LAMOTRIGIN Used For?
| Indication | Reports |
|---|---|
| Epilepsy | 15 |
| Bipolar disorder | 5 |
Official FDA Label for LAMOTRIGIN
Official prescribing information from the FDA-approved drug label.