85/100 · Critical
Manufactured by WinCo Foods, LLC
High Safety Concerns with RANITIDINE HYDROCHLORIDE Linked to Cancer and Serious Reactions
90,318 FDA adverse event reports analyzed
Last updated: 2026-05-12
RANITIDINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by WinCo Foods, LLC. Based on analysis of 90,318 FDA adverse event reports, RANITIDINE HYDROCHLORIDE 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 HYDROCHLORIDE include BREAST CANCER, PROSTATE CANCER, BLADDER CANCER, COLORECTAL CANCER, RENAL CANCER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RANITIDINE HYDROCHLORIDE.
Ranitidine Hydrochloride 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 90,318 adverse event reports for this medication, which is primarily manufactured by Winco Foods, Llc.
The most commonly reported adverse events include Breast Cancer, Prostate Cancer, Bladder Cancer. Of classified reports, 95.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Over 50,000 serious adverse events reported, with a high proportion of cancer-related reactions.
Multiple gastrointestinal cancers are frequently reported, indicating potential carcinogenic risks. A significant number of reports involve fatal outcomes and severe injuries.
Patients taking Ranitidine Hydrochloride should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. RANITIDINE HYDROCHLORIDE is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of gastrointestinal malignancies. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ranitidine Hydrochloride received a safety concern score of 85/100 (high concern). This is based on a 95.3% serious event ratio across 53,750 classified reports. The score accounts for 90,318 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: 17,687, Male: 17,253, Unknown: 7. The most frequently reported age groups are age 58 (558 reports), age 63 (457 reports), age 43 (432 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,750 classified reports for RANITIDINE HYDROCHLORIDE:
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 HYDROCHLORIDE is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of gastrointestinal malignancies.
If you are taking Ranitidine Hydrochloride, here are important things to know. The most commonly reported side effects include breast cancer, prostate cancer, bladder cancer, colorectal 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. Avoid using RANITIDINE HYDROCHLORIDE if you have a history of gastrointestinal cancers or hypersensitivity to the drug. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 a warning to discontinue the use of ranitidine due to potential N-nitrosamine impurities, which may be carcinogenic. Patients should consult their healthcare provider for alternative treatments.
The FDA has received approximately 90,318 adverse event reports associated with Ranitidine Hydrochloride. 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 Hydrochloride include Breast Cancer, Prostate Cancer, Bladder Cancer, Colorectal Cancer, Renal Cancer. By volume, the top reported reactions are: Breast Cancer (7,733 reports), Prostate Cancer (7,126 reports), Bladder Cancer (5,173 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 Hydrochloride.
Out of 53,750 classified reports, 51,207 (95.3%) were classified as serious and 2,543 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 Hydrochloride break down by patient sex as follows: Female: 17,687, Male: 17,253, Unknown: 7. 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 Hydrochloride adverse events are: age 58: 558 reports, age 63: 457 reports, age 43: 432 reports, age 65: 431 reports, age 62: 422 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 Hydrochloride adverse event reports is Winco Foods, Llc. 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 Hydrochloride include: Oesophageal Carcinoma, Neoplasm Malignant, 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 Hydrochloride 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 Hydrochloride 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. Over 50,000 serious adverse events reported, with a high proportion of cancer-related reactions.
Key safety signals identified in Ranitidine Hydrochloride's adverse event data include: Multiple types of cancer (breast, prostate, bladder, colorectal, renal, etc.) are frequently reported.. High incidence of serious reactions, with over 95% of reports being serious.. A large volume of reports involving gastrointestinal disorders and malignancies.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
RANITIDINE HYDROCHLORIDE is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of gastrointestinal malignancies. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ranitidine Hydrochloride.
Avoid using RANITIDINE HYDROCHLORIDE if you have a history of gastrointestinal cancers or hypersensitivity to the drug. Report any unusual symptoms or side effects to your healthcare provider immediately.
Ranitidine Hydrochloride has 90,318 adverse event reports on file with the FDA. Multiple gastrointestinal cancers are frequently reported, indicating potential carcinogenic risks. The volume of reports for Ranitidine Hydrochloride reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued a warning to discontinue the use of ranitidine due to potential N-nitrosamine impurities, which may be carcinogenic. Patients should consult their healthcare provider for alternative treatments. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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