82/100 · Critical
Manufactured by ANI Pharmaceuticals, Inc.
Naproxen Adverse Events Show High Seriousness and Diverse Reactions
280,499 FDA adverse event reports analyzed
Last updated: 2026-05-12
NAPROXEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 280,499 FDA adverse event reports, NAPROXEN 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 NAPROXEN include DRUG INEFFECTIVE, PAIN, FATIGUE, ARTHRALGIA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NAPROXEN.
Naproxen 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 280,499 adverse event reports for this medication, which is primarily manufactured by Ani Pharmaceuticals, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 79.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Naproxen reports show a high percentage of serious adverse events (79.8%).
The most common reactions include pain, fatigue, and arthralgia, indicating potential musculoskeletal issues. A wide range of reactions are reported, suggesting a diverse safety profile.
Patients taking Naproxen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Naproxen can cause serious adverse events such as kidney injury and respiratory issues. It is important to follow prescribed dosages and consult a healthcare provider if any side effects occur. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Naproxen received a safety concern score of 82/100 (high concern). This is based on a 79.8% serious event ratio across 75,905 classified reports. The score accounts for 280,499 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: 46,204, Male: 22,841, Unknown: 156. The most frequently reported age groups are age 40 (1,494 reports), age 43 (1,473 reports), age 61 (1,362 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 75,905 classified reports for NAPROXEN:
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 can cause serious adverse events such as kidney injury and respiratory issues. It is important to follow prescribed dosages and consult a healthcare provider if any side effects occur.
If you are taking Naproxen, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, arthralgia, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosages and consult a healthcare provider if any side effects occur. Be aware of potential serious adverse events such as kidney injury and respiratory issues. 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 safety. Healthcare providers should be vigilant in monitoring patients for serious adverse events and adjust treatment as necessary.
The FDA has received approximately 280,499 adverse event reports associated with Naproxen. 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 include Drug Ineffective, Pain, Fatigue, Arthralgia, Nausea. By volume, the top reported reactions are: Drug Ineffective (9,822 reports), Pain (8,758 reports), Fatigue (7,338 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.
Out of 75,905 classified reports, 60,539 (79.8%) were classified as serious and 15,366 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 break down by patient sex as follows: Female: 46,204, Male: 22,841, Unknown: 156. 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 adverse events are: age 40: 1,494 reports, age 43: 1,473 reports, age 61: 1,362 reports, age 56: 1,347 reports, age 60: 1,328 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 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 Naproxen include: Off Label Use, Headache, Diarrhoea, Vomiting, Dizziness. 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 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 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. Naproxen reports show a high percentage of serious adverse events (79.8%).
Key safety signals identified in Naproxen's adverse event data include: High percentage of serious adverse events (79.8%).. Common reactions include pain, fatigue, and arthralgia.. Diverse reactions reported, including respiratory, gastrointestinal, and neurological issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Naproxen can cause serious adverse events such as kidney injury and respiratory issues. It is important to follow prescribed dosages and consult a healthcare provider if any side effects occur. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Naproxen.
Follow prescribed dosages and consult a healthcare provider if any side effects occur. Be aware of potential serious adverse events such as kidney injury and respiratory issues.
Naproxen has 280,499 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and arthralgia, indicating potential musculoskeletal issues. The volume of reports for Naproxen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor naproxen safety. Healthcare providers should be vigilant in monitoring patients for serious adverse events and adjust treatment as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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