78/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Naproxen Sodium Adverse Events Show High Serious Reaction Rate
430,327 FDA adverse event reports analyzed
Last updated: 2026-05-12
NAPROXEN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 430,327 FDA adverse event reports, NAPROXEN SODIUM 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 NAPROXEN SODIUM include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NAPROXEN SODIUM.
Naproxen Sodium 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 430,327 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 60.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (60.7%) indicates significant safety concerns.
A wide range of reactions reported, including gastrointestinal, musculoskeletal, and respiratory issues. Report volume is substantial, with over 430,000 reports, providing a comprehensive dataset for analysis. Fatigue, nausea, and pain are among the most frequently reported symptoms, suggesting common side effects.
Patients taking Naproxen Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Naproxen Sodium can interact with other NSAIDs, potentially increasing the risk of gastrointestinal bleeding and renal impairment. It is contraindicated in patients with known hypersensitivity to the drug. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Naproxen Sodium received a safety concern score of 78/100 (high concern). This is based on a 60.7% serious event ratio across 138,892 classified reports. The score accounts for 430,327 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: 83,228, Male: 39,699, Unknown: 241. The most frequently reported age groups are age 43 (2,574 reports), age 44 (2,209 reports), age 61 (2,113 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 138,892 classified reports for NAPROXEN SODIUM:
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 can interact with other NSAIDs, potentially increasing the risk of gastrointestinal bleeding and renal impairment. It is contraindicated in patients with known hypersensitivity to the drug.
If you are taking Naproxen Sodium, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, arthralgia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult a healthcare provider if you experience severe or persistent side effects such as shortness of breath, chest pain, or gastrointestinal issues. Do not exceed the recommended dose and follow the prescribed duration of use. 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 for safety, and updates are regularly issued based on new data. Healthcare providers should be vigilant in monitoring patients for adverse reactions and adjust dosing or discontinue use as necessary.
The FDA has received approximately 430,327 adverse event reports associated with Naproxen Sodium. 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 include Drug Ineffective, Pain, Fatigue, Nausea, Arthralgia. By volume, the top reported reactions are: Drug Ineffective (19,782 reports), Pain (12,135 reports), Fatigue (11,213 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.
Out of 138,892 classified reports, 84,275 (60.7%) were classified as serious and 54,617 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 break down by patient sex as follows: Female: 83,228, Male: 39,699, Unknown: 241. 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 adverse events are: age 43: 2,574 reports, age 44: 2,209 reports, age 61: 2,113 reports, age 60: 2,094 reports, age 56: 1,999 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 adverse event reports is Aurobindo Pharma Limited. 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 include: Headache, Off Label Use, Diarrhoea, Dizziness, Vomiting. 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 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 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 (60.7%) indicates significant safety concerns.
Key safety signals identified in Naproxen Sodium's adverse event data include: High rate of serious reactions (84,275 out of 138,892, or 60.7%). Diverse range of reactions including gastrointestinal, musculoskeletal, and respiratory issues. Significant number of reports related to cardiovascular effects (e.g., hypertension, chest pain). These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Naproxen Sodium can interact with other NSAIDs, potentially increasing the risk of gastrointestinal bleeding and renal impairment. It is contraindicated in patients with known hypersensitivity to the drug. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Naproxen Sodium.
Consult a healthcare provider if you experience severe or persistent side effects such as shortness of breath, chest pain, or gastrointestinal issues. Do not exceed the recommended dose and follow the prescribed duration of use.
Naproxen Sodium has 430,327 adverse event reports on file with the FDA. A wide range of reactions reported, including gastrointestinal, musculoskeletal, and respiratory issues. The volume of reports for Naproxen Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Naproxen Sodium for safety, and updates are regularly issued based on new data. Healthcare providers should be vigilant in monitoring patients for adverse reactions and adjust dosing or discontinue use as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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