85/100 · Critical
Manufactured by Ajanta Pharma USA Inc.
High Safety Concerns with RANITIDINE Linked to Cancer and Serious Adverse Events
308,223 FDA adverse event reports analyzed
Last updated: 2026-05-12
RANITIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Ajanta Pharma USA Inc.. Based on analysis of 308,223 FDA adverse event reports, RANITIDINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for RANITIDINE include BREAST CANCER, PROSTATE CANCER, COLORECTAL CANCER, BLADDER CANCER, RENAL CANCER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RANITIDINE.
Ranitidine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 308,223 adverse event reports for this medication, which is primarily manufactured by Ajanta Pharma Usa Inc..
The most commonly reported adverse events include Breast Cancer, Prostate Cancer, Colorectal Cancer. Of classified reports, 93.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. RANITIDINE reports show a high incidence of cancer-related adverse events, particularly breast, prostate, and colorectal cancers.
Serious adverse events account for 93.4% of all reports, indicating significant health risks. The drug is frequently reported to be ineffective or cause incorrect dose administration.
Patients taking Ranitidine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. RANITIDINE has been linked to various drug interactions, and its use in unapproved indications is also a concern. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ranitidine received a safety concern score of 85/100 (high concern). This is based on a 93.4% serious event ratio across 197,401 classified reports. The score accounts for 308,223 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 90,207, Male: 83,164, Unknown: 136. The most frequently reported age groups are age 58 (2,904 reports), age 59 (2,763 reports), age 60 (2,732 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 197,401 classified reports for RANITIDINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
RANITIDINE has been linked to various drug interactions, and its use in unapproved indications is also a concern.
If you are taking Ranitidine, here are important things to know. The most commonly reported side effects include breast cancer, prostate cancer, colorectal cancer, bladder cancer, renal cancer. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and consult a healthcare provider if you experience any side effects. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has issued warnings about RANITIDINE due to potential carcinogenic risks, and its use should be closely monitored.
The FDA has received approximately 308,223 adverse event reports associated with Ranitidine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Ranitidine include Breast Cancer, Prostate Cancer, Colorectal Cancer, Bladder Cancer, Renal Cancer. By volume, the top reported reactions are: Breast Cancer (24,853 reports), Prostate Cancer (22,252 reports), Colorectal Cancer (17,674 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ranitidine.
Out of 197,401 classified reports, 184,388 (93.4%) were classified as serious and 13,013 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Ranitidine break down by patient sex as follows: Female: 90,207, Male: 83,164, Unknown: 136. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Ranitidine adverse events are: age 58: 2,904 reports, age 59: 2,763 reports, age 60: 2,732 reports, age 61: 2,690 reports, age 62: 2,680 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Ranitidine adverse event reports is Ajanta Pharma Usa Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Ranitidine include: Oesophageal Carcinoma, Incorrect Dose Administered, Hepatic Cancer, Gastric Cancer, Pancreatic Carcinoma. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Ranitidine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Ranitidine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. RANITIDINE reports show a high incidence of cancer-related adverse events, particularly breast, prostate, and colorectal cancers.
Key safety signals identified in Ranitidine's adverse event data include: Multiple cancer types are reported, including breast, prostate, and colorectal cancers.. Serious adverse events are prevalent, with a high percentage of reports being serious.. Incorrect dose administration is a common issue, suggesting potential misuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
RANITIDINE has been linked to various drug interactions, and its use in unapproved indications is also a concern. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ranitidine.
Follow prescribed dosages and consult a healthcare provider if you experience any side effects. Be aware of potential drug interactions and inform your healthcare provider of all medications you are taking.
Ranitidine has 308,223 adverse event reports on file with the FDA. Serious adverse events account for 93.4% of all reports, indicating significant health risks. The volume of reports for Ranitidine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings about RANITIDINE due to potential carcinogenic risks, and its use should be closely monitored. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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