85/100 · Critical
Manufactured by Altaire Pharmaceuticals Inc.
High Serious Reaction Rate for Diclofenac Adverse Events
487,456 FDA adverse event reports analyzed
Last updated: 2026-05-12
DICLOFENAC is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Altaire Pharmaceuticals Inc.. Based on analysis of 487,456 FDA adverse event reports, DICLOFENAC has a safety score of 85 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 DICLOFENAC include DRUG INEFFECTIVE, PAIN, FATIGUE, RHEUMATOID ARTHRITIS, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICLOFENAC.
Diclofenac has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 487,456 adverse event reports for this medication, which is primarily manufactured by Altaire Pharmaceuticals Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 80.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. A high percentage (80.4%) of reported reactions are serious, indicating significant health risks.
The most common reactions include pain, fatigue, and rash, suggesting a broad spectrum of potential side effects. The reaction diversity is high, with over 100 distinct reactions reported, indicating a complex safety profile.
Patients taking Diclofenac should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Diclofenac can cause serious adverse reactions such as gastrointestinal ulcers, liver injury, and respiratory issues. It should be used with caution, especially in patients with pre-existing conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diclofenac received a safety concern score of 85/100 (high concern). This is based on a 80.4% serious event ratio across 82,138 classified reports. The score accounts for 487,456 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: 49,183, Male: 23,060, Unknown: 186. The most frequently reported age groups are age 44 (2,818 reports), age 43 (2,756 reports), age 59 (1,562 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 82,138 classified reports for DICLOFENAC:
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 can cause serious adverse reactions such as gastrointestinal ulcers, liver injury, and respiratory issues. It should be used with caution, especially in patients with pre-existing conditions.
If you are taking Diclofenac, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, rheumatoid arthritis, rash. 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. Report any unusual symptoms or side effects to your healthcare provider immediately. 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 for safety, and regulatory actions may be taken based on ongoing data analysis.
The FDA has received approximately 487,456 adverse event reports associated with Diclofenac. 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 include Drug Ineffective, Pain, Fatigue, Rheumatoid Arthritis, Rash. By volume, the top reported reactions are: Drug Ineffective (13,688 reports), Pain (12,279 reports), Fatigue (11,316 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.
Out of 82,138 classified reports, 66,080 (80.4%) were classified as serious and 16,058 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 break down by patient sex as follows: Female: 49,183, Male: 23,060, Unknown: 186. 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 adverse events are: age 44: 2,818 reports, age 43: 2,756 reports, age 59: 1,562 reports, age 40: 1,544 reports, age 60: 1,242 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 adverse event reports is Altaire 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 Diclofenac include: Arthralgia, Off Label Use, Abdominal Discomfort, Alopecia, Systemic Lupus Erythematosus. 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 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 has a safety concern score of 85 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. A high percentage (80.4%) of reported reactions are serious, indicating significant health risks.
Key safety signals identified in Diclofenac's adverse event data include: High percentage of serious reactions (80.4%). Common reactions include pain, fatigue, and rash. Over 100 distinct reactions reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Diclofenac can cause serious adverse reactions such as gastrointestinal ulcers, liver injury, and respiratory issues. It should be used with caution, especially in patients with pre-existing conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diclofenac.
Always follow the prescribed dosage and duration of use as directed by a healthcare provider. Report any unusual symptoms or side effects to your healthcare provider immediately.
Diclofenac has 487,456 adverse event reports on file with the FDA. The most common reactions include pain, fatigue, and rash, suggesting a broad spectrum of potential side effects. The volume of reports for Diclofenac reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor diclofenac for safety, and regulatory actions may be taken based on ongoing data analysis. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with DICLOFENAC:
Drugs related to DICLOFENAC based on therapeutic use, drug class, or shared indications: