PRILOSEC OTC: 534 Adverse Event Reports & Safety Profile
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534
Total FAERS Reports
1 (0.2%)
Deaths Reported
53
Hospitalizations
534
As Primary/Secondary Suspect
5
Life-Threatening
41
Disabilities
First Report: 1987 · Latest Report: 20140510
What Are the Most Common PRILOSEC OTC Side Effects?
#1 Most Reported
Drug ineffective
118 reports (22.1%)
#2 Most Reported
Dyspepsia
94 reports (17.6%)
#3 Most Reported
Intentional product misuse
75 reports (14.0%)
All PRILOSEC OTC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 118 | 22.1% | 1 | 11 |
| Dyspepsia | 94 | 17.6% | 0 | 7 |
| Intentional product misuse | 75 | 14.0% | 0 | 5 |
| Gastrooesophageal reflux disease | 68 | 12.7% | 0 | 8 |
| Osteoporosis | 61 | 11.4% | 0 | 37 |
| Drug dose omission | 56 | 10.5% | 0 | 9 |
| Abdominal pain upper | 53 | 9.9% | 0 | 5 |
| Off label use | 49 | 9.2% | 0 | 7 |
| Diarrhoea | 47 | 8.8% | 0 | 7 |
| Nausea | 39 | 7.3% | 0 | 0 |
| Malaise | 38 | 7.1% | 1 | 7 |
| Bone disorder | 37 | 6.9% | 0 | 22 |
| Arthritis | 35 | 6.6% | 0 | 20 |
| Multiple fractures | 35 | 6.6% | 0 | 20 |
| Incorrect drug administration duration | 30 | 5.6% | 0 | 0 |
| Abdominal discomfort | 29 | 5.4% | 1 | 3 |
| Inappropriate schedule of drug administration | 29 | 5.4% | 0 | 0 |
| Fall | 28 | 5.2% | 0 | 16 |
| Condition aggravated | 27 | 5.1% | 0 | 0 |
| Depression | 27 | 5.1% | 0 | 14 |
Who Reports PRILOSEC OTC Side Effects? Age & Gender Data
Average age: 59.3 years. Most reports from: US. View detailed demographics →
Is PRILOSEC OTC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 3 | 0 | 1 |
| 2001 | 9 | 0 | 4 |
| 2002 | 7 | 0 | 4 |
| 2003 | 8 | 0 | 3 |
| 2004 | 5 | 0 | 2 |
| 2005 | 3 | 0 | 1 |
| 2006 | 5 | 0 | 4 |
| 2007 | 9 | 0 | 4 |
| 2008 | 10 | 0 | 4 |
| 2009 | 11 | 0 | 4 |
| 2010 | 11 | 0 | 6 |
| 2011 | 8 | 0 | 3 |
| 2012 | 10 | 0 | 1 |
| 2013 | 65 | 1 | 4 |
| 2014 | 30 | 0 | 3 |
What Is PRILOSEC OTC Used For?
| Indication | Reports |
|---|---|
| Gastrooesophageal reflux disease | 130 |
| Dyspepsia | 64 |
| Hiatus hernia | 6 |
| Abdominal pain upper | 5 |
PRILOSEC OTC vs Alternatives: Which Is Safer?
PRILOSEC OTC vs PRIMAQUINE
PRILOSEC OTC vs PRIMIDONE
PRILOSEC OTC vs PRISTINAMYCIN
PRILOSEC OTC vs PRISTIQ
PRILOSEC OTC vs PRIVIGEN
PRILOSEC OTC vs PROAIR HFA
PRILOSEC OTC vs PROBIOTICS NOS
PRILOSEC OTC vs PROBUCOL
PRILOSEC OTC vs PROCAINAMIDE
PRILOSEC OTC vs PROCAINE
Official FDA Label for PRILOSEC OTC
Official prescribing information from the FDA-approved drug label.