78/100 · Elevated
Manufactured by Bausch Health US LLC
Famotidine Adverse Events Show High Serious Reaction Rate
216,979 FDA adverse event reports analyzed
Last updated: 2026-05-12
FAMOTIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bausch Health US LLC. Based on analysis of 216,979 FDA adverse event reports, FAMOTIDINE has a safety score of 78 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 FAMOTIDINE include NAUSEA, FATIGUE, CHRONIC KIDNEY DISEASE, DIARRHOEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FAMOTIDINE.
Famotidine has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 216,979 adverse event reports for this medication, which is primarily manufactured by Bausch Health Us Llc.
The most commonly reported adverse events include Nausea, Fatigue, Chronic Kidney Disease. Of classified reports, 64.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (64.6%) indicates significant safety concerns.
A wide range of reactions reported, including renal and cardiovascular issues. Significant number of reports involving chronic kidney disease and acute kidney injury.
Patients taking Famotidine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Famotidine may interact with other medications, and warnings include potential for renal and cardiovascular issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Famotidine received a safety concern score of 78/100 (high concern). This is based on a 64.6% serious event ratio across 109,911 classified reports. The score accounts for 216,979 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: 61,564, Male: 37,554, Unknown: 106. The most frequently reported age groups are age 67 (1,745 reports), age 66 (1,734 reports), age 71 (1,724 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 109,911 classified reports for FAMOTIDINE:
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.
Famotidine may interact with other medications, and warnings include potential for renal and cardiovascular issues.
If you are taking Famotidine, here are important things to know. The most commonly reported side effects include nausea, fatigue, chronic kidney disease, diarrhoea, drug ineffective. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of renal impairment and cardiovascular issues, especially in elderly patients. Follow prescribed dosing instructions to avoid drug interactions and overdose. 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.
Regulatory bodies are monitoring the safety of famotidine, with a focus on renal and cardiovascular side effects.
The FDA has received approximately 216,979 adverse event reports associated with Famotidine. 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 Famotidine include Nausea, Fatigue, Chronic Kidney Disease, Diarrhoea, Drug Ineffective. By volume, the top reported reactions are: Nausea (7,257 reports), Fatigue (6,867 reports), Chronic Kidney Disease (6,644 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Famotidine.
Out of 109,911 classified reports, 70,981 (64.6%) were classified as serious and 38,930 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 Famotidine break down by patient sex as follows: Female: 61,564, Male: 37,554, Unknown: 106. 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 Famotidine adverse events are: age 67: 1,745 reports, age 66: 1,734 reports, age 71: 1,724 reports, age 70: 1,718 reports, age 69: 1,692 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 Famotidine adverse event reports is Bausch Health Us 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 Famotidine include: Off Label Use, Dyspnoea, Headache, Acute Kidney Injury, Pain. 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 Famotidine 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.
Famotidine has a safety concern score of 78 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. High percentage of serious adverse events (64.6%) indicates significant safety concerns.
Key safety signals identified in Famotidine's adverse event data include: Chronic kidney disease and acute kidney injury are frequently reported.. A high number of serious reactions, particularly involving the respiratory and cardiovascular systems.. Renal impairment and renal failure are common adverse events.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Famotidine may interact with other medications, and warnings include potential for renal and cardiovascular issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Famotidine.
Monitor for signs of renal impairment and cardiovascular issues, especially in elderly patients. Follow prescribed dosing instructions to avoid drug interactions and overdose.
Famotidine has 216,979 adverse event reports on file with the FDA. A wide range of reactions reported, including renal and cardiovascular issues. The volume of reports for Famotidine reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies are monitoring the safety of famotidine, with a focus on renal and cardiovascular side effects. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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