Ranitidine
According to the FDA label: Ranitidine Tablets are indicated in: Short- term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of Ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo- controlled comparative studies have been carried out for periods of longer than 1 year.
197,541 adverse event reports submitted to the FDA (1999–2026)
Top Reported Adverse Events
The most frequently reported events in association with Ranitidine 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 24,854 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 22,252 reports
- Colorectal Cancer 17,674 reports
- Bladder Cancer 16,746 reports
- Renal Cancer 16,278 reports
- Oesophageal Carcinoma 9,648 reports
Incorrect Dose Administered 9,632 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →- Hepatic Cancer 7,592 reports
- Gastric Cancer 7,538 reports
- Pancreatic Carcinoma 6,840 reports
- Lung Neoplasm Malignant 6,760 reports
Nausea 4,730 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Chronic Kidney Disease 4,687 reports
A long-term, gradual loss of kidney function over months or years.
Full definition in the glossary →Fatigue 4,473 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 4,060 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 | 90,292 |
| Male | 83,195 |
| Unknown | 136 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 3,117 |
| 18-34 | 4,736 |
| 35-49 | 16,279 |
| 50-64 | 36,287 |
| 65-74 | 20,626 |
| 75+ | 11,506 |
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. 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 | 163,130 |
| Hospitalization | 26,031 |
| Death | 15,475 |
| Non-Serious | 13,022 |
| Life-Threatening | 4,706 |
| Disability | 3,511 |
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. 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 |
|---|---|
| 1999 | 1 |
| 2003 | 2 |
| 2004 | 1,127 |
| 2005 | 1,199 |
| 2006 | 1,152 |
| 2007 | 840 |
| 2008 | 968 |
| 2009 | 1,465 |
| 2010 | 1,680 |
| 2011 | 1,810 |
| 2012 | 2,543 |
| 2013 | 2,557 |
| 2014 | 3,174 |
| 2015 | 4,458 |
| 2016 | 5,226 |
| 2017 | 5,101 |
| 2018 | 7,691 |
| 2019 | 9,714 |
| 2020 | 20,720 |
| 2021 | 97,239 |
| 2022 | 18,397 |
| 2023 | 8,060 |
| 2024 | 1,273 |
| 2025 | 1,022 |
| 2026 (partial) | 122 |
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
In FDA adverse event reports that mention Ranitidine, these medications appeared most often in the same report.
- Omeprazole (11,224 reports)
- Acetaminophen (9,241 reports)
- Furosemide (8,734 reports)
- Aspirin (8,459 reports)
- Prednisone (7,629 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