72/100 · Elevated
Manufactured by ANI Pharmaceuticals, Inc.
Meloxicam Adverse Events: High Serious Reaction Rate
151,308 FDA adverse event reports analyzed
Last updated: 2026-05-12
MELOXICAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ANI Pharmaceuticals, Inc.. Based on analysis of 151,308 FDA adverse event reports, MELOXICAM has a safety score of 72 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 MELOXICAM 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 MELOXICAM.
Meloxicam has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 151,308 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, 57.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (57.9%) among reported reactions.
Pain and gastrointestinal issues are the most common reported reactions. Chronic kidney disease and acute kidney injury are notable safety concerns.
Patients taking Meloxicam should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Meloxicam can cause serious kidney issues and respiratory problems. It should be used with caution in patients with pre-existing kidney or respiratory conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Meloxicam received a safety concern score of 72/100 (elevated concern). This is based on a 57.9% serious event ratio across 55,801 classified reports. The score accounts for 151,308 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 36,970, Male: 14,618, Unknown: 82. The most frequently reported age groups are age 62 (1,120 reports), age 60 (1,052 reports), age 64 (1,032 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 55,801 classified reports for MELOXICAM:
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.
Meloxicam can cause serious kidney issues and respiratory problems. It should be used with caution in patients with pre-existing kidney or respiratory conditions.
If you are taking Meloxicam, 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. Monitor for signs of kidney dysfunction and respiratory issues, especially in elderly patients. Follow prescribed dosages and do not exceed recommended 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 closely monitors Meloxicam for safety, particularly for serious adverse events. Regular monitoring of kidney function and respiratory status is recommended.
The FDA has received approximately 151,308 adverse event reports associated with Meloxicam. 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 Meloxicam include Drug Ineffective, Pain, Fatigue, Arthralgia, Nausea. By volume, the top reported reactions are: Drug Ineffective (5,900 reports), Pain (4,667 reports), Fatigue (4,577 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Meloxicam.
Out of 55,801 classified reports, 32,304 (57.9%) were classified as serious and 23,497 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 Meloxicam break down by patient sex as follows: Female: 36,970, Male: 14,618, Unknown: 82. 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 Meloxicam adverse events are: age 62: 1,120 reports, age 60: 1,052 reports, age 64: 1,032 reports, age 61: 1,023 reports, age 63: 1,018 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 Meloxicam 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 Meloxicam include: Headache, Diarrhoea, Dyspnoea, Dizziness, Pain In Extremity. 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 Meloxicam 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.
Meloxicam has a safety concern score of 72 out of 100 (elevated 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 (57.9%) among reported reactions.
Key safety signals identified in Meloxicam's adverse event data include: Chronic kidney disease and acute kidney injury reported in 2336 and 1602 cases respectively.. High incidence of respiratory issues like dyspnea and pneumonia.. Multiple musculoskeletal issues including arthralgia and joint swelling.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Meloxicam can cause serious kidney issues and respiratory problems. It should be used with caution in patients with pre-existing kidney or respiratory conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Meloxicam.
Monitor for signs of kidney dysfunction and respiratory issues, especially in elderly patients. Follow prescribed dosages and do not exceed recommended use.
Meloxicam has 151,308 adverse event reports on file with the FDA. Pain and gastrointestinal issues are the most common reported reactions. The volume of reports for Meloxicam reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Meloxicam for safety, particularly for serious adverse events. Regular monitoring of kidney function and respiratory status is recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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