NICOTROL: 95 Adverse Event Reports & Safety Profile
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95
Total FAERS Reports
0
Deaths Reported
12
Hospitalizations
95
As Primary/Secondary Suspect
First Report: 2010 · Latest Report: 20140618
What Are the Most Common NICOTROL Side Effects?
#1 Most Reported
Drug ineffective
29 reports (30.5%)
#2 Most Reported
Product quality issue
14 reports (14.7%)
#3 Most Reported
Pneumonia
11 reports (11.6%)
All NICOTROL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 29 | 30.5% | 0 | 0 |
| Product quality issue | 14 | 14.7% | 0 | 0 |
| Pneumonia | 11 | 11.6% | 0 | 9 |
| Throat irritation | 9 | 9.5% | 0 | 3 |
| Headache | 7 | 7.4% | 0 | 2 |
| Malaise | 7 | 7.4% | 0 | 2 |
| Myocardial infarction | 7 | 7.4% | 0 | 3 |
| Bronchitis | 6 | 6.3% | 0 | 3 |
| Drug intolerance | 6 | 6.3% | 0 | 0 |
| Dizziness | 5 | 5.3% | 0 | 0 |
| Oropharyngeal pain | 5 | 5.3% | 0 | 0 |
Who Reports NICOTROL Side Effects? Age & Gender Data
Average age: 60.1 years. Most reports from: US. View detailed demographics →
Is NICOTROL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2010 | 3 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 4 | 0 | 2 |
| 2013 | 7 | 0 | 2 |
| 2014 | 34 | 0 | 7 |
What Is NICOTROL Used For?
| Indication | Reports |
|---|---|
| Smoking cessation therapy | 51 |
| Product used for unknown indication | 8 |
Official FDA Label for NICOTROL
Official prescribing information from the FDA-approved drug label.