82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
High Serious Reaction Rate for Valsartan Oral
102,285 FDA adverse event reports analyzed
Last updated: 2026-05-12
VALSARTAN ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 102,285 FDA adverse event reports, VALSARTAN ORAL 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 ORAL include DRUG INEFFECTIVE, FATIGUE, DYSPNOEA, NAUSEA, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VALSARTAN ORAL.
Valsartan Oral 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 102,285 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Fatigue, Dyspnoea. Of classified reports, 78.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage of reports (78.8%) involve serious adverse events.
The most common reactions include dyspnoea, fatigue, and nausea. Serious conditions such as acute kidney injury and renal failure are frequently reported. Drug interactions and falls are also notable safety concerns.
Patients taking Valsartan Oral should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Patients should be monitored for signs of drug interactions and be cautious of falls, especially in elderly patients. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Valsartan Oral received a safety concern score of 82/100 (high concern). This is based on a 78.8% serious event ratio across 51,993 classified reports. The score accounts for 102,285 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: 26,374, Male: 20,719, Unknown: 58. The most frequently reported age groups are age 71 (1,194 reports), age 74 (1,186 reports), age 68 (1,123 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 51,993 classified reports for VALSARTAN ORAL:
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.
Patients should be monitored for signs of drug interactions and be cautious of falls, especially in elderly patients.
If you are taking Valsartan Oral, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, dyspnoea, nausea, dizziness. 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 serious adverse events such as kidney injury and cardiac failure. Report any side effects to the FDA's MedWatch program. 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 is investigating valsartan for potential contamination and safety concerns; patients should consult their healthcare provider if they experience severe symptoms.
The FDA has received approximately 102,285 adverse event reports associated with Valsartan Oral. 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 Oral include Drug Ineffective, Fatigue, Dyspnoea, Nausea, Dizziness. By volume, the top reported reactions are: Drug Ineffective (3,761 reports), Fatigue (2,948 reports), Dyspnoea (2,802 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 Oral.
Out of 51,993 classified reports, 40,996 (78.8%) were classified as serious and 10,997 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 Oral break down by patient sex as follows: Female: 26,374, Male: 20,719, Unknown: 58. 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 Oral adverse events are: age 71: 1,194 reports, age 74: 1,186 reports, age 68: 1,123 reports, age 70: 1,086 reports, age 69: 1,063 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 Oral adverse event reports is Ani Pharmaceuticals, 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 Valsartan Oral include: Diarrhoea, Headache, Acute Kidney Injury, Off Label Use, Hypertension. 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 Oral 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 Oral 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. A high percentage of reports (78.8%) involve serious adverse events.
Key safety signals identified in Valsartan Oral's adverse event data include: Acute kidney injury and renal failure are frequent and serious reactions.. Falls and drug interactions are common, indicating potential safety risks.. Serious conditions like cardiac failure and cerebrovascular accident are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Patients should be monitored for signs of drug interactions and be cautious of falls, especially in elderly patients. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Valsartan Oral.
Monitor for signs of serious adverse events such as kidney injury and cardiac failure. Report any side effects to the FDA's MedWatch program.
Valsartan Oral has 102,285 adverse event reports on file with the FDA. The most common reactions include dyspnoea, fatigue, and nausea. The volume of reports for Valsartan Oral reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is investigating valsartan for potential contamination and safety concerns; patients should consult their healthcare provider if they experience severe symptoms. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by ANI Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with VALSARTAN ORAL:
Drugs related to VALSARTAN ORAL based on therapeutic use, drug class, or shared indications: