FLAGYL: 265 Adverse Event Reports & Safety Profile
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265
Total FAERS Reports
10 (3.8%)
Deaths Reported
77
Hospitalizations
265
As Primary/Secondary Suspect
14
Life-Threatening
5
Disabilities
First Report: 20040215 · Latest Report: 20140514
What Are the Most Common FLAGYL Side Effects?
#1 Most Reported
Drug hypersensitivity
107 reports (40.4%)
#2 Most Reported
Vomiting
13 reports (4.9%)
#3 Most Reported
Pruritus
12 reports (4.5%)
All FLAGYL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 107 | 40.4% | 0 | 0 |
| Vomiting | 13 | 4.9% | 0 | 9 |
| Diarrhoea | 12 | 4.5% | 0 | 8 |
| Pruritus | 12 | 4.5% | 3 | 6 |
| Drug ineffective | 11 | 4.2% | 1 | 4 |
| Nausea | 11 | 4.2% | 0 | 3 |
| Pyrexia | 11 | 4.2% | 0 | 10 |
| General physical health deterioration | 8 | 3.0% | 2 | 7 |
| Rash | 8 | 3.0% | 0 | 0 |
| Rash maculo-papular | 8 | 3.0% | 2 | 7 |
| Urticaria | 8 | 3.0% | 0 | 1 |
| Eosinophilia | 7 | 2.6% | 3 | 6 |
| Hypoaesthesia | 7 | 2.6% | 0 | 2 |
| Malaise | 7 | 2.6% | 0 | 3 |
| Renal failure acute | 7 | 2.6% | 2 | 7 |
| Abdominal pain | 6 | 2.3% | 0 | 3 |
| Cholestasis | 6 | 2.3% | 1 | 3 |
| Dehydration | 6 | 2.3% | 0 | 6 |
| Drug reaction with eosinophilia and systemic symptoms | 6 | 2.3% | 0 | 6 |
| Erythema | 6 | 2.3% | 0 | 4 |
Who Reports FLAGYL Side Effects? Age & Gender Data
Average age: 57.1 years. Most reports from: US. View detailed demographics →
Is FLAGYL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 1 |
| 2006 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 1 |
| 2009 | 2 | 0 | 1 |
| 2010 | 3 | 0 | 1 |
| 2011 | 4 | 0 | 2 |
| 2012 | 5 | 0 | 5 |
| 2013 | 57 | 7 | 37 |
| 2014 | 54 | 0 | 27 |
What Is FLAGYL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 46 |
| Clostridium difficile infection | 11 |
| Infection | 7 |
| Diverticulitis | 6 |
FLAGYL vs Alternatives: Which Is Safer?
FLAGYL vs FLECAINIDE
FLAGYL vs FLIBANSERIN
FLAGYL vs FLOLAN
FLAGYL vs FLUCICLOVINE F-18
FLAGYL vs FLUCLOXACILLIN
FLAGYL vs FLUCONAZOLE
FLAGYL vs FLUCYTOSINE
FLAGYL vs FLUDARABINE
FLAGYL vs FLUDEOXYGLUCOSE F-18
FLAGYL vs FLUDROCORTISONE
Official FDA Label for FLAGYL
Official prescribing information from the FDA-approved drug label.