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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.

RANITIDINE\RANITIDINE: 728 Adverse Event Reports & Safety Profile

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Total FAERS Reports
32 (4.4%)
Deaths Reported
159
Hospitalizations
728
As Primary/Secondary Suspect
35
Life-Threatening
22
Disabilities

Active Ingredient: RANITIDINE\RANITIDINE HYDROCHLORIDE ·

First Report: 19931211 · Latest Report: 20160308

What Are the Most Common RANITIDINE\RANITIDINE Side Effects?

#1 Most Reported
Drug ineffective
97 reports (13.3%)
#2 Most Reported
Product quality issue
56 reports (7.7%)
#3 Most Reported
Pruritus
38 reports (5.2%)

All RANITIDINE\RANITIDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 97 13.3% 0 3
Product quality issue 56 7.7% 0 0
Pruritus 38 5.2% 0 4
Dyspnoea 32 4.4% 0 10
Insomnia 30 4.1% 0 2
Nausea 30 4.1% 0 9
Angioedema 29 4.0% 0 2
Hypotension 26 3.6% 0 21
Diarrhoea 25 3.4% 0 1
Anaphylactic reaction 24 3.3% 0 5
Malaise 24 3.3% 0 11
Abdominal pain upper 23 3.2% 0 2
Drug hypersensitivity 23 3.2% 0 4
Muscle spasms 23 3.2% 0 1
Vomiting 23 3.2% 0 11
Hypersensitivity 21 2.9% 0 3
Tachycardia 21 2.9% 0 16
Cardiac arrest 20 2.8% 2 17
Hypertension 19 2.6% 2 8
Condition aggravated 18 2.5% 0 0

Who Reports RANITIDINE\RANITIDINE Side Effects? Age & Gender Data

Gender: 66.3% female, 33.7% male. Average age: 51.8 years. Most reports from: US. View detailed demographics →

Is RANITIDINE\RANITIDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2001 4 2 4
2002 1 0 0
2004 6 0 3
2007 2 0 0
2008 1 0 1
2009 3 0 0
2010 1 0 0
2011 9 0 1
2012 8 2 3
2013 49 2 7
2014 143 7 36
2015 114 1 28
2016 13 0 8

View full timeline →

What Is RANITIDINE\RANITIDINE Used For?

IndicationReports
Product used for unknown indication 238
Gastrooesophageal reflux disease 139
Dyspepsia 74
Premedication 15
Chronic spontaneous urticaria 14
Gastritis 13
Prophylaxis against gastrointestinal ulcer 11
Prophylaxis 10
Abdominal pain upper 8
Reflux laryngitis 7

RANITIDINE\RANITIDINE vs Alternatives: Which Is Safer?

RANITIDINE\RANITIDINE vs RANOLAZINE RANITIDINE\RANITIDINE vs RAPAMUNE RANITIDINE\RANITIDINE vs RASAGILINE RANITIDINE\RANITIDINE vs RASBURICASE RANITIDINE\RANITIDINE vs RAVULIZUMAB RANITIDINE\RANITIDINE vs RAVULIZUMAB-CWVZ RANITIDINE\RANITIDINE vs REBAMIPIDE RANITIDINE\RANITIDINE vs REBETOL RANITIDINE\RANITIDINE vs REBIF RANITIDINE\RANITIDINE vs REBOXETINE

Official FDA Label for RANITIDINE\RANITIDINE

Official prescribing information from the FDA-approved drug label.