LAMICTAL: 901 Adverse Event Reports & Safety Profile
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901
Total FAERS Reports
30 (3.3%)
Deaths Reported
251
Hospitalizations
901
As Primary/Secondary Suspect
39
Life-Threatening
31
Disabilities
First Report: 1196 · Latest Report: 20140804
What Are the Most Common LAMICTAL Side Effects?
#1 Most Reported
Convulsion
136 reports (15.1%)
#2 Most Reported
Rash
83 reports (9.2%)
#3 Most Reported
Malaise
52 reports (5.8%)
All LAMICTAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Convulsion | 136 | 15.1% | 3 | 39 |
| Rash | 83 | 9.2% | 0 | 39 |
| Malaise | 52 | 5.8% | 2 | 12 |
| Pyrexia | 49 | 5.4% | 0 | 41 |
| Drug ineffective | 48 | 5.3% | 2 | 8 |
| Fatigue | 45 | 5.0% | 0 | 11 |
| Headache | 41 | 4.6% | 0 | 11 |
| Nausea | 39 | 4.3% | 0 | 17 |
| Insomnia | 33 | 3.7% | 0 | 9 |
| Dizziness | 31 | 3.4% | 1 | 8 |
| Drug administration error | 30 | 3.3% | 0 | 2 |
| Drug hypersensitivity | 29 | 3.2% | 0 | 4 |
| Anxiety | 28 | 3.1% | 0 | 5 |
| Epilepsy | 28 | 3.1% | 0 | 6 |
| Investigation | 28 | 3.1% | 0 | 27 |
| Foetal exposure during pregnancy | 27 | 3.0% | 2 | 5 |
| Stevens-johnson syndrome | 27 | 3.0% | 1 | 19 |
| Drug eruption | 26 | 2.9% | 0 | 18 |
| Depression | 25 | 2.8% | 0 | 10 |
| Tremor | 24 | 2.7% | 0 | 9 |
Who Reports LAMICTAL Side Effects? Age & Gender Data
Average age: 42.7 years. Most reports from: US. View detailed demographics →
Is LAMICTAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 3 | 0 | 3 |
| 2003 | 1 | 0 | 0 |
| 2004 | 1 | 0 | 1 |
| 2005 | 5 | 0 | 1 |
| 2006 | 6 | 0 | 3 |
| 2007 | 5 | 0 | 1 |
| 2008 | 10 | 0 | 1 |
| 2009 | 12 | 0 | 2 |
| 2010 | 13 | 0 | 3 |
| 2011 | 20 | 0 | 9 |
| 2012 | 60 | 4 | 23 |
| 2013 | 186 | 8 | 65 |
| 2014 | 124 | 7 | 66 |
What Is LAMICTAL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 295 |
| Epilepsy | 160 |
| Bipolar disorder | 133 |
| Convulsion | 110 |
| Depression | 29 |
| Affective disorder | 15 |
| Nervous system disorder | 13 |
| Partial seizures | 11 |
| Bipolar i disorder | 9 |
| Temporal lobe epilepsy | 6 |
LAMICTAL vs Alternatives: Which Is Safer?
LAMICTAL vs LAMIVUDINE
LAMICTAL vs LAMIVUDINE\NEVIRAPINE\ZIDOVUDINE
LAMICTAL vs LAMIVUDINE\TENOFOVIR
LAMICTAL vs LAMIVUDINE\TENOFOVIR DISOPROXIL
LAMICTAL vs LAMIVUDINE\ZIDOVUDINE
LAMICTAL vs LAMOTRIGINE
LAMICTAL vs LANADELUMAB
LAMICTAL vs LANADELUMAB-FLYO
LAMICTAL vs LANREOTIDE
LAMICTAL vs LANSOPRAZOLE
Official FDA Label for LAMICTAL
Official prescribing information from the FDA-approved drug label.