BENADRYL: 140 Adverse Event Reports & Safety Profile
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140
Total FAERS Reports
7 (5.0%)
Deaths Reported
29
Hospitalizations
140
As Primary/Secondary Suspect
2
Life-Threatening
3
Disabilities
First Report: 1999 · Latest Report: 20140606
What Are the Most Common BENADRYL Side Effects?
#1 Most Reported
Drug hypersensitivity
32 reports (22.9%)
#2 Most Reported
Drug ineffective
15 reports (10.7%)
#3 Most Reported
Pruritus
14 reports (10.0%)
All BENADRYL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug hypersensitivity | 32 | 22.9% | 0 | 0 |
| Drug ineffective | 15 | 10.7% | 2 | 4 |
| Nausea | 14 | 10.0% | 0 | 4 |
| Pruritus | 14 | 10.0% | 0 | 1 |
| Dyspnoea | 13 | 9.3% | 0 | 4 |
| Infusion related reaction | 12 | 8.6% | 0 | 4 |
| Dizziness | 11 | 7.9% | 0 | 1 |
| Blood pressure increased | 9 | 6.4% | 0 | 3 |
| Headache | 9 | 6.4% | 0 | 3 |
| Somnolence | 9 | 6.4% | 0 | 1 |
| Arthralgia | 8 | 5.7% | 0 | 0 |
| Fatigue | 8 | 5.7% | 0 | 1 |
| Urticaria | 8 | 5.7% | 0 | 0 |
| Heart rate increased | 7 | 5.0% | 0 | 2 |
| Anxiety | 6 | 4.3% | 0 | 2 |
| Chest discomfort | 6 | 4.3% | 0 | 1 |
| Chest pain | 6 | 4.3% | 0 | 2 |
| Injection site pain | 6 | 4.3% | 0 | 0 |
| Off label use | 6 | 4.3% | 0 | 1 |
| Rash | 6 | 4.3% | 0 | 2 |
Who Reports BENADRYL Side Effects? Age & Gender Data
Average age: 47.4 years. Most reports from: US. View detailed demographics →
Is BENADRYL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 3 | 0 | 2 |
| 2012 | 6 | 0 | 0 |
| 2013 | 22 | 3 | 9 |
| 2014 | 33 | 0 | 9 |
What Is BENADRYL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 34 |
| Premedication | 15 |
| Pruritus | 10 |
BENADRYL vs Alternatives: Which Is Safer?
BENADRYL vs BENAZEPRIL
BENADRYL vs BENDAMUSTINE
BENADRYL vs BENDROFLUMETHIAZIDE
BENADRYL vs BENIDIPINE
BENADRYL vs BENLYSTA
BENADRYL vs BENRALIZUMAB
BENADRYL vs BENSERAZIDE
BENADRYL vs BENSERAZIDE\LEVODOPA
BENADRYL vs BENZALKONIUM
BENADRYL vs BENZOCAINE
Official FDA Label for BENADRYL
Official prescribing information from the FDA-approved drug label.