75/100 · Elevated
Manufactured by Pfizer Laboratories Div Pfizer Inc
Highly Reported Adverse Reactions for DICLOFENAC SODIUM AND MISOPROSTOL
22,203 FDA adverse event reports analyzed
Last updated: 2026-05-12
DICLOFENAC SODIUM AND MISOPROSTOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 22,203 FDA adverse event reports, DICLOFENAC SODIUM AND MISOPROSTOL has a safety score of 75 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 SODIUM AND MISOPROSTOL include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, RHEUMATOID ARTHRITIS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DICLOFENAC SODIUM AND MISOPROSTOL.
Diclofenac Sodium And Misoprostol has a safety concern score of 75 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 22,203 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Drug Ineffective, Pain, Arthralgia. Of classified reports, 75.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and arthralgia are the most commonly reported reactions, indicating potential musculoskeletal side effects.
Serious adverse events, such as pneumonia and myocardial infarction, are reported but less frequently. Drug ineffectiveness and off-label use are also significant concerns, suggesting potential misuse or inefficacy issues.
Patients taking Diclofenac Sodium And Misoprostol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other NSAIDs and misoprostol can lead to increased risk of gastrointestinal and cardiovascular side effects. Warnings are present for these interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Diclofenac Sodium And Misoprostol received a safety concern score of 75/100 (elevated concern). This is based on a 75.5% serious event ratio across 6,608 classified reports. The score accounts for 22,203 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: 4,439, Male: 1,650, Unknown: 13. The most frequently reported age groups are age 55 (255 reports), age 60 (228 reports), age 65 (152 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 6,608 classified reports for DICLOFENAC SODIUM AND MISOPROSTOL:
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.
Interactions with other NSAIDs and misoprostol can lead to increased risk of gastrointestinal and cardiovascular side effects. Warnings are present for these interactions.
If you are taking Diclofenac Sodium And Misoprostol, here are important things to know. The most commonly reported side effects include drug ineffective, pain, arthralgia, rheumatoid arthritis, 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 serious adverse events such as pneumonia and myocardial infarction. Be cautious with off-label use and ensure the drug is effective for the intended condition. 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 monitors these drugs closely due to the high number of reports and serious adverse events. Regular monitoring by healthcare providers is advised.
The FDA has received approximately 22,203 adverse event reports associated with Diclofenac Sodium And Misoprostol. 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 And Misoprostol include Drug Ineffective, Pain, Arthralgia, Rheumatoid Arthritis, Nausea. By volume, the top reported reactions are: Drug Ineffective (1,196 reports), Pain (900 reports), Arthralgia (780 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 And Misoprostol.
Out of 6,608 classified reports, 4,991 (75.5%) were classified as serious and 1,617 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 Diclofenac Sodium And Misoprostol break down by patient sex as follows: Female: 4,439, Male: 1,650, Unknown: 13. 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 And Misoprostol adverse events are: age 55: 255 reports, age 60: 228 reports, age 65: 152 reports, age 67: 151 reports, age 58: 138 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 And Misoprostol adverse event reports is Pfizer Laboratories Div Pfizer 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 Sodium And Misoprostol include: Fatigue, Drug Hypersensitivity, Diarrhoea, Malaise, Headache. 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 And Misoprostol 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 And Misoprostol has a safety concern score of 75 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. Pain and arthralgia are the most commonly reported reactions, indicating potential musculoskeletal side effects.
Key safety signals identified in Diclofenac Sodium And Misoprostol's adverse event data include: Pain and arthralgia are the most frequent reactions.. Serious reactions like pneumonia and myocardial infarction are reported but less common.. Drug ineffectiveness and off-label use are notable safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other NSAIDs and misoprostol can lead to increased risk of gastrointestinal and cardiovascular side effects. Warnings are present for these interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Diclofenac Sodium And Misoprostol.
Monitor for signs of serious adverse events such as pneumonia and myocardial infarction. Be cautious with off-label use and ensure the drug is effective for the intended condition.
Diclofenac Sodium And Misoprostol has 22,203 adverse event reports on file with the FDA. Serious adverse events, such as pneumonia and myocardial infarction, are reported but less frequently. The volume of reports for Diclofenac Sodium And Misoprostol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA monitors these drugs closely due to the high number of reports and serious adverse events. Regular monitoring by healthcare providers is advised. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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