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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

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

YearReportsDeathsHosp.
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

View full timeline →

What Is ZANTAC Used For?

IndicationReports
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.