65/100 · Elevated
Manufactured by Haleon US Holdings LLC
Diclofenac Sodium Reports Show Widespread Mild to Moderate Adverse Reactions
574,671 FDA adverse event reports analyzed
Last updated: 2026-05-12
DICLOFENAC SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 574,671 FDA adverse event reports, DICLOFENAC SODIUM has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for DICLOFENAC SODIUM include DRUG INEFFECTIVE, PAIN, FATIGUE, PRODUCT USE IN UNAPPROVED INDICATION, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICLOFENAC SODIUM.
Diclofenac Sodium has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 574,671 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 60.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are mild to moderate in severity, with pain and fatigue being the most common.
There is a notable increase in serious adverse events, particularly gastrointestinal issues and infections. Drug ineffectiveness and off-label use are also frequently reported, indicating potential misuse or inefficacy concerns.
Patients taking Diclofenac Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diclofenac sodium may interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. 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.
Diclofenac Sodium received a safety concern score of 65/100 (elevated concern). This is based on a 60.0% serious event ratio across 145,255 classified reports. The score accounts for 574,671 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: 76,484, Male: 36,807, Unknown: 233. The most frequently reported age groups are age 44 (3,042 reports), age 43 (3,018 reports), age 59 (2,029 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 145,255 classified reports for DICLOFENAC 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.
Diclofenac sodium may interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. It is contraindicated in patients with known hypersensitivity to the drug.
If you are taking Diclofenac Sodium, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, product use in unapproved indication, off label use. 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 duration of use as directed by a healthcare provider. Be aware of potential interactions with other medications and inform your healthcare provider of all drugs you are taking. 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 diclofenac sodium for safety, and updates will be issued as necessary. Patients should report any adverse reactions to the FDA's MedWatch program.
The FDA has received approximately 574,671 adverse event reports associated with Diclofenac 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 Diclofenac Sodium include Drug Ineffective, Pain, Fatigue, Product Use In Unapproved Indication, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (29,162 reports), Pain (14,383 reports), Fatigue (12,871 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Diclofenac Sodium.
Out of 145,255 classified reports, 87,090 (60.0%) were classified as serious and 58,165 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 Diclofenac Sodium break down by patient sex as follows: Female: 76,484, Male: 36,807, Unknown: 233. 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 Diclofenac Sodium adverse events are: age 44: 3,042 reports, age 43: 3,018 reports, age 59: 2,029 reports, age 40: 1,763 reports, age 65: 1,744 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 Diclofenac Sodium adverse event reports is Haleon Us Holdings 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 Diclofenac Sodium include: Arthralgia, Rash, Rheumatoid Arthritis, Abdominal Discomfort, Product Use Issue. 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 Diclofenac 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.
Diclofenac Sodium has a safety concern score of 65 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. The majority of reported reactions are mild to moderate in severity, with pain and fatigue being the most common.
Key safety signals identified in Diclofenac Sodium's adverse event data include: Gastrointestinal issues such as duodenal ulcer perforation and hepatitis are reported, indicating potential risks.. Infections, including pneumonia and lower respiratory tract infections, are also common.. Serious adverse events account for 60% of all reported outcomes, highlighting the need for caution.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Diclofenac sodium may interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. 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 Diclofenac Sodium.
Always follow the prescribed dosage and duration of use as directed by a healthcare provider. Be aware of potential interactions with other medications and inform your healthcare provider of all drugs you are taking.
Diclofenac Sodium has 574,671 adverse event reports on file with the FDA. There is a notable increase in serious adverse events, particularly gastrointestinal issues and infections. The volume of reports for Diclofenac Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor diclofenac sodium for safety, and updates will be issued as necessary. Patients should report any adverse reactions to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Haleon US Holdings LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with DICLOFENAC SODIUM:
Drugs related to DICLOFENAC SODIUM based on therapeutic use, drug class, or shared indications: