35/100 · Moderate
Manufactured by Bayer HealthCare LLC.
Naproxen Sodium Tablet Adverse Events: Common Minor Issues, Serious Reactions Not Frequent
85,607 FDA adverse event reports analyzed
Last updated: 2026-05-12
NAPROXEN SODIUM TABLET is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Bayer HealthCare LLC.. Based on analysis of 85,607 FDA adverse event reports, NAPROXEN SODIUM TABLET has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for NAPROXEN SODIUM TABLET include DRUG INEFFECTIVE, PRODUCT USE ISSUE, FATIGUE, NAUSEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NAPROXEN SODIUM TABLET.
Naproxen Sodium Tablet has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 85,607 adverse event reports for this medication, which is primarily manufactured by Bayer Healthcare Llc..
The most commonly reported adverse events include Drug Ineffective, Product Use Issue, Fatigue. Of classified reports, 31.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Most reported issues are minor and non-serious, such as fatigue, nausea, and pain.
Serious adverse events are less common, with only 31.9% of reports being serious. The majority of reports involve drug ineffectiveness or product misuse. Age distribution shows a higher number of reports from individuals aged 60-70. Sex distribution is more common in females, with a higher count of reports.
Patients taking Naproxen Sodium Tablet should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Naproxen Sodium Tablet reports include warnings for incorrect administration and dosing, which can lead to serious adverse events such as renal failure and pneumonia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Naproxen Sodium Tablet received a safety concern score of 35/100 (moderate concern). This is based on a 31.9% serious event ratio across 52,149 classified reports. The score accounts for 85,607 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 30,512, Male: 14,419, Unknown: 52. The most frequently reported age groups are age 64 (711 reports), age 60 (657 reports), age 61 (655 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 52,149 classified reports for NAPROXEN SODIUM TABLET:
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.
Naproxen Sodium Tablet reports include warnings for incorrect administration and dosing, which can lead to serious adverse events such as renal failure and pneumonia.
If you are taking Naproxen Sodium Tablet, here are important things to know. The most commonly reported side effects include drug ineffective, product use issue, fatigue, nausea, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Always follow the prescribed dosage and instructions for use to avoid potential adverse events. Report any unusual symptoms to your healthcare provider promptly. 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 continues to monitor Naproxen Sodium Tablet for safety, with no significant changes to the current labeling or warnings.
The FDA has received approximately 85,607 adverse event reports associated with Naproxen Sodium Tablet. 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 Naproxen Sodium Tablet include Drug Ineffective, Product Use Issue, Fatigue, Nausea, Pain. By volume, the top reported reactions are: Drug Ineffective (8,006 reports), Product Use Issue (3,722 reports), Fatigue (2,359 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Naproxen Sodium Tablet.
Out of 52,149 classified reports, 16,649 (31.9%) were classified as serious and 35,500 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 Naproxen Sodium Tablet break down by patient sex as follows: Female: 30,512, Male: 14,419, Unknown: 52. 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 Naproxen Sodium Tablet adverse events are: age 64: 711 reports, age 60: 657 reports, age 61: 655 reports, age 66: 649 reports, age 70: 648 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 Naproxen Sodium Tablet adverse event reports is Bayer Healthcare 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 Naproxen Sodium Tablet include: Headache, Dizziness, Arthralgia, Diarrhoea, Therapeutic Response Unexpected. 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 Naproxen Sodium Tablet 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.
Naproxen Sodium Tablet has a safety concern score of 35 out of 100 (moderate 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. Most reported issues are minor and non-serious, such as fatigue, nausea, and pain.
Key safety signals identified in Naproxen Sodium Tablet's adverse event data include: Drug ineffectiveness is a common issue, indicating potential dosing or efficacy concerns.. Product misuse and incorrect administration are frequent, suggesting a need for better patient education.. Serious reactions, though less frequent, include conditions like pneumonia and renal failure.. Age-related issues suggest potential safety concerns for elderly patients.. Sex distribution differences may indicate gender-specific safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Naproxen Sodium Tablet reports include warnings for incorrect administration and dosing, which can lead to serious adverse events such as renal failure and pneumonia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Naproxen Sodium Tablet.
Always follow the prescribed dosage and instructions for use to avoid potential adverse events. Report any unusual symptoms to your healthcare provider promptly.
Naproxen Sodium Tablet has 85,607 adverse event reports on file with the FDA. Serious adverse events are less common, with only 31.9% of reports being serious. The volume of reports for Naproxen Sodium Tablet reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Naproxen Sodium Tablet for safety, with no significant changes to the current labeling or warnings. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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