TOPAMAX: 281 Adverse Event Reports & Safety Profile
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281
Total FAERS Reports
3 (1.1%)
Deaths Reported
86
Hospitalizations
281
As Primary/Secondary Suspect
15
Life-Threatening
8
Disabilities
First Report: 1998 · Latest Report: 20140625
What Are the Most Common TOPAMAX Side Effects?
#1 Most Reported
Convulsion
35 reports (12.5%)
#2 Most Reported
Foetal exposure during pregnancy
30 reports (10.7%)
#3 Most Reported
Drug ineffective
22 reports (7.8%)
All TOPAMAX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Convulsion | 35 | 12.5% | 0 | 14 |
| Foetal exposure during pregnancy | 30 | 10.7% | 2 | 12 |
| Drug ineffective | 22 | 7.8% | 0 | 1 |
| Exposure during pregnancy | 19 | 6.8% | 0 | 3 |
| Depression | 18 | 6.4% | 0 | 6 |
| Emotional disorder | 16 | 5.7% | 0 | 7 |
| Self injurious behaviour | 16 | 5.7% | 0 | 0 |
| Cleft lip and palate | 15 | 5.3% | 0 | 10 |
| Drug hypersensitivity | 15 | 5.3% | 0 | 2 |
| Weight decreased | 15 | 5.3% | 0 | 6 |
| Epilepsy | 14 | 5.0% | 0 | 2 |
| Off label use | 13 | 4.6% | 0 | 2 |
| Insomnia | 12 | 4.3% | 0 | 5 |
| Migraine | 12 | 4.3% | 0 | 5 |
| Otitis media chronic | 12 | 4.3% | 0 | 8 |
| Atrial septal defect | 11 | 3.9% | 0 | 7 |
| Drug abuse | 11 | 3.9% | 0 | 2 |
| Headache | 11 | 3.9% | 0 | 3 |
| Intentional overdose | 11 | 3.9% | 0 | 2 |
| Premature baby | 11 | 3.9% | 0 | 11 |
Who Reports TOPAMAX Side Effects? Age & Gender Data
Average age: 29.6 years. Most reports from: US. View detailed demographics →
Is TOPAMAX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 2 | 0 | 1 |
| 2005 | 8 | 0 | 3 |
| 2006 | 6 | 0 | 4 |
| 2007 | 4 | 0 | 1 |
| 2008 | 4 | 0 | 3 |
| 2009 | 3 | 0 | 1 |
| 2010 | 7 | 0 | 2 |
| 2011 | 11 | 1 | 6 |
| 2012 | 11 | 1 | 4 |
| 2013 | 27 | 0 | 13 |
| 2014 | 62 | 0 | 11 |
What Is TOPAMAX Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 79 |
| Migraine | 36 |
| Epilepsy | 32 |
| Foetal exposure during pregnancy | 28 |
| Convulsion | 24 |
| Headache | 9 |
| Depression | 8 |
| Migraine prophylaxis | 8 |
| Bipolar disorder | 6 |
| Anxiety | 5 |
TOPAMAX vs Alternatives: Which Is Safer?
TOPAMAX vs TOPIRAMATE
TOPAMAX vs TOPOTECAN
TOPAMAX vs TOPOTECAN\TOPOTECAN
TOPAMAX vs TOPROL
TOPAMAX vs TOREMIFENE
TOPAMAX vs TORIPALIMAB
TOPAMAX vs TORSEMIDE
TOPAMAX vs TOVIAZ
TOPAMAX vs TOVORAFENIB
TOPAMAX vs TOZINAMERAN
Official FDA Label for TOPAMAX
Official prescribing information from the FDA-approved drug label.