Ranitidine Hydrochloride
53,643 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ranitidine Hydrochloride in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Breast Cancer 7,733 reports
A cancer that forms in the tissue of the breast. It may appear in reports as a condition being treated or monitored.
Full definition in the glossary →- Prostate Cancer 7,125 reports
- Bladder Cancer 5,173 reports
- Colorectal Cancer 5,102 reports
- Renal Cancer 4,846 reports
- Oesophageal Carcinoma 2,998 reports
Neoplasm Malignant 2,747 reports
The medical term for a cancerous growth. It may appear in reports as a condition being treated or monitored.
Full definition in the glossary →- Hepatic Cancer 2,343 reports
- Gastric Cancer 2,321 reports
- Pancreatic Carcinoma 2,244 reports
- Lung Neoplasm Malignant 1,962 reports
Injury 1,764 reports
A general report of physical harm to the body, used when no more specific type is given.
Full definition in the glossary →Pain 1,456 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Off Label Use 1,399 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Drug Ineffective 1,195 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 17,625 |
| Male | 17,188 |
| Unknown | 7 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 327 |
| 18-34 | 607 |
| 35-49 | 3,186 |
| 50-64 | 5,626 |
| 65-74 | 3,124 |
| 75+ | 1,540 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Ranitidine Hydrochloride. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 48,383 |
| Death | 4,304 |
| Hospitalization | 3,304 |
| Non-Serious | 2,434 |
| Disability | 1,123 |
| Life-Threatening | 1,096 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Ranitidine Hydrochloride. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 229 |
| 2005 | 253 |
| 2006 | 137 |
| 2007 | 112 |
| 2008 | 120 |
| 2009 | 121 |
| 2010 | 131 |
| 2011 | 128 |
| 2012 | 232 |
| 2013 | 122 |
| 2014 | 141 |
| 2015 | 160 |
| 2016 | 307 |
| 2017 | 512 |
| 2018 | 1,207 |
| 2019 | 991 |
| 2020 | 3,268 |
| 2021 | 34,757 |
| 2022 | 4,741 |
| 2023 | 4,006 |
| 2024 | 967 |
| 2025 | 889 |
| 2026 (partial) | 112 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Ranitidine Hydrochloride
In FDA adverse event reports that mention Ranitidine Hydrochloride, these medications appeared most often in the same report.
- Acetaminophen (2,112 reports)
- Pantoprazole (1,911 reports)
- Cetirizine (1,617 reports)
- Methylprednisolone (1,499 reports)
- Diclofenac (1,456 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026