NEURONTIN: 984 Adverse Event Reports & Safety Profile
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984
Total FAERS Reports
31 (3.2%)
Deaths Reported
70
Hospitalizations
984
As Primary/Secondary Suspect
8
Life-Threatening
22
Disabilities
First Report: 1981 · Latest Report: 20140610
What Are the Most Common NEURONTIN Side Effects?
#1 Most Reported
Drug ineffective
208 reports (21.1%)
#2 Most Reported
Drug hypersensitivity
203 reports (20.6%)
#3 Most Reported
Off label use
73 reports (7.4%)
All NEURONTIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 208 | 21.1% | 1 | 3 |
| Drug hypersensitivity | 203 | 20.6% | 1 | 3 |
| Off label use | 73 | 7.4% | 1 | 9 |
| Pain | 60 | 6.1% | 1 | 7 |
| Dizziness | 39 | 4.0% | 2 | 0 |
| Drug ineffective for unapproved indication | 38 | 3.9% | 0 | 0 |
| Malaise | 35 | 3.6% | 1 | 3 |
| Feeling abnormal | 31 | 3.2% | 0 | 4 |
| Pain in extremity | 28 | 2.9% | 1 | 2 |
| Somnolence | 28 | 2.9% | 0 | 2 |
| Hypoaesthesia | 27 | 2.7% | 0 | 3 |
| Drug intolerance | 25 | 2.5% | 0 | 0 |
| Back pain | 23 | 2.3% | 0 | 3 |
| Paraesthesia | 22 | 2.2% | 1 | 2 |
| Depression | 21 | 2.1% | 0 | 3 |
| Weight increased | 21 | 2.1% | 0 | 2 |
| Convulsion | 20 | 2.0% | 0 | 3 |
| Fatigue | 19 | 1.9% | 0 | 2 |
| Insomnia | 19 | 1.9% | 0 | 2 |
| Nausea | 19 | 1.9% | 2 | 1 |
Who Reports NEURONTIN Side Effects? Age & Gender Data
Average age: 56.8 years. Most reports from: US. View detailed demographics →
Is NEURONTIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 3 | 0 | 0 |
| 2002 | 1 | 0 | 0 |
| 2003 | 2 | 0 | 0 |
| 2004 | 2 | 0 | 0 |
| 2005 | 1 | 0 | 0 |
| 2006 | 5 | 0 | 0 |
| 2007 | 6 | 2 | 1 |
| 2008 | 5 | 0 | 0 |
| 2009 | 6 | 2 | 2 |
| 2010 | 10 | 1 | 1 |
| 2011 | 13 | 0 | 0 |
| 2012 | 34 | 1 | 6 |
| 2013 | 109 | 12 | 28 |
| 2014 | 98 | 2 | 9 |
What Is NEURONTIN Used For?
| Indication | Reports |
|---|---|
| Neuropathy peripheral | 79 |
| Neuralgia | 57 |
| Fibromyalgia | 56 |
| Diabetic neuropathy | 47 |
| Pain | 47 |
| Nerve injury | 26 |
| Convulsion | 24 |
| Product used for unknown indication | 21 |
| Back pain | 19 |
| Hypoaesthesia | 10 |
NEURONTIN vs Alternatives: Which Is Safer?
NEURONTIN vs NEVIRAPINE
NEURONTIN vs NEXAVAR
NEURONTIN vs NEXIUM
NEURONTIN vs NEXPLANON
NEURONTIN vs NIACIN
NEURONTIN vs NIACINAMIDE
NEURONTIN vs NICARDIPINE
NEURONTIN vs NICORANDIL
NEURONTIN vs NICORETTE OTC
NEURONTIN vs NICORETTE OTC, UNSPECIFIED
Official FDA Label for NEURONTIN
Official prescribing information from the FDA-approved drug label.