ZANTAC: 195 Adverse Event Reports & Safety Profile
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195
Total FAERS Reports
3 (1.5%)
Deaths Reported
22
Hospitalizations
195
As Primary/Secondary Suspect
8
Life-Threatening
2
Disabilities
First Report: 1993 · Latest Report: 20140613
What Are the Most Common ZANTAC Side Effects?
#1 Most Reported
Drug ineffective
29 reports (14.9%)
#2 Most Reported
Off label use
20 reports (10.3%)
#3 Most Reported
Gastrooesophageal reflux disease
10 reports (5.1%)
All ZANTAC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 29 | 14.9% | 0 | 4 |
| Off label use | 20 | 10.3% | 0 | 0 |
| Dyspepsia | 10 | 5.1% | 0 | 0 |
| Dyspnoea | 10 | 5.1% | 0 | 0 |
| Gastrooesophageal reflux disease | 10 | 5.1% | 0 | 3 |
| Headache | 9 | 4.6% | 0 | 1 |
| Nausea | 9 | 4.6% | 0 | 1 |
| Drug hypersensitivity | 8 | 4.1% | 0 | 0 |
| Diarrhoea | 7 | 3.6% | 0 | 1 |
| Dizziness | 7 | 3.6% | 0 | 1 |
| Feeling abnormal | 7 | 3.6% | 0 | 4 |
| Incorrect drug administration duration | 7 | 3.6% | 0 | 0 |
| Malaise | 7 | 3.6% | 0 | 3 |
| Product quality issue | 7 | 3.6% | 0 | 0 |
| Abdominal pain | 6 | 3.1% | 0 | 0 |
| Abdominal pain upper | 6 | 3.1% | 0 | 0 |
| Foreign body | 6 | 3.1% | 0 | 0 |
| Constipation | 5 | 2.6% | 0 | 1 |
| Drug screen positive | 5 | 2.6% | 0 | 0 |
| Exposure during pregnancy | 5 | 2.6% | 1 | 1 |
Who Reports ZANTAC Side Effects? Age & Gender Data
Average age: 54.5 years. Most reports from: US. View detailed demographics →
Is ZANTAC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2005 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 1 |
| 2011 | 3 | 0 | 1 |
| 2012 | 7 | 0 | 2 |
| 2013 | 45 | 1 | 5 |
| 2014 | 62 | 1 | 5 |
What Is ZANTAC Used For?
| Indication | Reports |
|---|---|
| Dyspepsia | 62 |
| Product used for unknown indication | 45 |
| Gastrooesophageal reflux disease | 21 |
| Prophylaxis | 6 |
| Premedication | 5 |
ZANTAC vs Alternatives: Which Is Safer?
ZANTAC vs ZANTAC 150
ZANTAC vs ZANUBRUTINIB
ZANTAC vs ZAVEGEPANT
ZANTAC vs ZEAXANTHIN
ZANTAC vs ZELBORAF
ZANTAC vs ZEMPLAR
ZANTAC vs ZENATANE
ZANTAC vs ZETIA
ZANTAC vs ZICONOTIDE
ZANTAC vs ZIDOVUDINE
Official FDA Label for ZANTAC
Official prescribing information from the FDA-approved drug label.