82/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
Valsartan Adverse Events Show High Seriousness and Diverse Reactions
196,487 FDA adverse event reports analyzed
Last updated: 2026-05-12
VALSARTAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 196,487 FDA adverse event reports, VALSARTAN has a safety score of 82 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 VALSARTAN include DRUG INEFFECTIVE, FATIGUE, DYSPNOEA, DIZZINESS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALSARTAN.
Valsartan has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 196,487 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Dyspnoea. Of classified reports, 76.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events reported are serious, with a high percentage of cardiovascular and renal issues.
A wide range of reactions are reported, indicating a diverse safety profile. Common reactions include fatigue, dyspnea, and dizziness, which are frequently reported.
Patients taking Valsartan should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Valsartan may interact with other drugs, leading to adverse effects. Warnings include monitoring for drug interactions and renal function. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Valsartan received a safety concern score of 82/100 (high concern). This is based on a 76.6% serious event ratio across 102,285 classified reports. The score accounts for 196,487 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: 56,198, Male: 39,602, Unknown: 152. The most frequently reported age groups are age 71 (2,065 reports), age 74 (2,046 reports), age 70 (2,012 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 102,285 classified reports for VALSARTAN:
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.
Valsartan may interact with other drugs, leading to adverse effects. Warnings include monitoring for drug interactions and renal function.
If you are taking Valsartan, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, dyspnoea, dizziness, nausea. 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 healthcare provider's advice on dosage and potential drug interactions. 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 authorities continue to monitor valsartan for safety, with ongoing investigations into potential issues.
The FDA has received approximately 196,487 adverse event reports associated with Valsartan. 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 Valsartan include Drug Ineffective, Fatigue, Dyspnoea, Dizziness, Nausea. By volume, the top reported reactions are: Drug Ineffective (6,226 reports), Fatigue (5,474 reports), Dyspnoea (5,255 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Valsartan.
Out of 102,285 classified reports, 78,324 (76.6%) were classified as serious and 23,961 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 Valsartan break down by patient sex as follows: Female: 56,198, Male: 39,602, Unknown: 152. 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 Valsartan adverse events are: age 71: 2,065 reports, age 74: 2,046 reports, age 70: 2,012 reports, age 68: 1,994 reports, age 69: 1,954 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 Valsartan adverse event reports is Novartis Pharmaceuticals Corporation. 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 Valsartan include: Diarrhoea, Headache, Hypertension, Blood Pressure Increased, 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 Valsartan 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.
Valsartan has a safety concern score of 82 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. The majority of adverse events reported are serious, with a high percentage of cardiovascular and renal issues.
Key safety signals identified in Valsartan's adverse event data include: Acute kidney injury and renal failure are key safety signals, indicating potential renal toxicity.. Cardiovascular events such as myocardial infarction and congestive heart failure are also significant.. Serious adverse events like death and sepsis are reported, highlighting the severity of some reactions.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Valsartan may interact with other drugs, leading to adverse effects. Warnings include monitoring for drug interactions and renal function. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Valsartan.
Monitor for signs of renal impairment and cardiovascular issues, especially in elderly patients. Follow healthcare provider's advice on dosage and potential drug interactions.
Valsartan has 196,487 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating a diverse safety profile. The volume of reports for Valsartan reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory authorities continue to monitor valsartan for safety, with ongoing investigations into potential issues. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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