PROTONIX: 298 Adverse Event Reports & Safety Profile
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298
Total FAERS Reports
10 (3.4%)
Deaths Reported
37
Hospitalizations
298
As Primary/Secondary Suspect
4
Life-Threatening
9
Disabilities
First Report: 1997 · Latest Report: 20140609
What Are the Most Common PROTONIX Side Effects?
#1 Most Reported
Drug hypersensitivity
37 reports (12.4%)
#2 Most Reported
Drug ineffective
32 reports (10.7%)
#3 Most Reported
Pain
26 reports (8.7%)
All PROTONIX Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 37 | 12.4% | 0 | 0 |
| Drug ineffective | 32 | 10.7% | 0 | 7 |
| Pain | 26 | 8.7% | 1 | 6 |
| Malaise | 20 | 6.7% | 1 | 2 |
| Cerebrovascular accident | 13 | 4.4% | 0 | 5 |
| Nausea | 11 | 3.7% | 0 | 3 |
| Off label use | 10 | 3.4% | 0 | 3 |
| Back pain | 9 | 3.0% | 1 | 5 |
| Muscle spasms | 9 | 3.0% | 0 | 2 |
| Myocardial infarction | 9 | 3.0% | 0 | 3 |
| Chest pain | 8 | 2.7% | 0 | 1 |
| Drug screen false positive | 8 | 2.7% | 0 | 0 |
| Gastrooesophageal reflux disease | 8 | 2.7% | 0 | 1 |
| Arthralgia | 7 | 2.4% | 0 | 0 |
| Depression | 7 | 2.4% | 0 | 2 |
| Diarrhoea | 7 | 2.4% | 0 | 0 |
| Dizziness | 7 | 2.4% | 0 | 1 |
| Dyspnoea | 7 | 2.4% | 0 | 2 |
| Fall | 7 | 2.4% | 0 | 1 |
| Pneumonia | 7 | 2.4% | 1 | 1 |
Who Reports PROTONIX Side Effects? Age & Gender Data
Average age: 61.2 years. Most reports from: US. View detailed demographics →
Is PROTONIX Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2002 | 2 | 0 | 0 |
| 2003 | 1 | 0 | 0 |
| 2006 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2010 | 3 | 0 | 3 |
| 2011 | 2 | 0 | 0 |
| 2012 | 6 | 0 | 1 |
| 2013 | 41 | 3 | 11 |
| 2014 | 36 | 1 | 5 |
What Is PROTONIX Used For?
| Indication | Reports |
|---|---|
| Gastrooesophageal reflux disease | 64 |
| Product used for unknown indication | 6 |
PROTONIX vs Alternatives: Which Is Safer?
PROTONIX vs PROTOPIC
PROTONIX vs PROVENGE
PROTONIX vs PROVENTIL
PROTONIX vs PROVERA
PROTONIX vs PROZAC
PROTONIX vs PRUCALOPRIDE
PROTONIX vs PSEUDOEPHEDRINE
PROTONIX vs PSEUDOEPHEDRINE\TRIPROLIDINE
PROTONIX vs PSYLLIUM HUSK
PROTONIX vs PULMICORT FLEXHALER
Official FDA Label for PROTONIX
Official prescribing information from the FDA-approved drug label.