82/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
Mesalamine Adverse Events: High Seriousness and Diverse Reactions
145,688 FDA adverse event reports analyzed
Last updated: 2026-05-12
MESALAMINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 145,688 FDA adverse event reports, MESALAMINE 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 MESALAMINE include OFF LABEL USE, DRUG INEFFECTIVE, COLITIS ULCERATIVE, DIARRHOEA, CONDITION AGGRAVATED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MESALAMINE.
Mesalamine 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 145,688 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Colitis Ulcerative. Of classified reports, 74.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Mesalamine reports show a high percentage of serious adverse events, particularly gastrointestinal issues and infections.
The most common reactions include diarrhea, abdominal pain, and hematochezia, indicating potential gastrointestinal side effects. A diverse range of reactions, including respiratory, neurological, and cardiovascular issues, suggests a broad safety profile.
Patients taking Mesalamine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mesalamine can cause gastrointestinal issues and infections, and patients should be monitored for these side effects. Drug interactions are not specifically noted, but caution is advised when used with other medications affecting the gastrointestinal This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mesalamine received a safety concern score of 82/100 (high concern). This is based on a 74.6% serious event ratio across 53,575 classified reports. The score accounts for 145,688 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: 27,625, Male: 20,411, Unknown: 159. The most frequently reported age groups are age 53 (724 reports), age 44 (718 reports), age 65 (705 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 53,575 classified reports for MESALAMINE:
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.
Mesalamine can cause gastrointestinal issues and infections, and patients should be monitored for these side effects. Drug interactions are not specifically noted, but caution is advised when used with other medications affecting the gastrointestinal
If you are taking Mesalamine, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, colitis ulcerative, diarrhoea, condition aggravated. 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 gastrointestinal bleeding, infections, and respiratory issues. Follow prescribed dosing instructions to minimize the risk of adverse reactions. 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 mesalamine for safety, and the drug is approved for the treatment of inflammatory bowel diseases. However, healthcare providers should be aware of the potential for serious adverse events and monitor patients closely.
The FDA has received approximately 145,688 adverse event reports associated with Mesalamine. 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 Mesalamine include Off Label Use, Drug Ineffective, Colitis Ulcerative, Diarrhoea, Condition Aggravated. By volume, the top reported reactions are: Off Label Use (8,840 reports), Drug Ineffective (6,886 reports), Colitis Ulcerative (6,301 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mesalamine.
Out of 53,575 classified reports, 39,988 (74.6%) were classified as serious and 13,587 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 Mesalamine break down by patient sex as follows: Female: 27,625, Male: 20,411, Unknown: 159. 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 Mesalamine adverse events are: age 53: 724 reports, age 44: 718 reports, age 65: 705 reports, age 62: 644 reports, age 71: 594 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 Mesalamine adverse event reports is Takeda Pharmaceuticals America, 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 Mesalamine include: Fatigue, Abdominal Pain, Haematochezia, Nausea, 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 Mesalamine 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.
Mesalamine 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. Mesalamine reports show a high percentage of serious adverse events, particularly gastrointestinal issues and infections.
Key safety signals identified in Mesalamine's adverse event data include: High percentage of serious adverse events (74.6%). Diverse range of reactions including gastrointestinal, respiratory, and neurological issues. Common reactions such as diarrhea, abdominal pain, and hematochezia. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mesalamine can cause gastrointestinal issues and infections, and patients should be monitored for these side effects. Drug interactions are not specifically noted, but caution is advised when used with other medications affecting the gastrointestinal Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mesalamine.
Monitor for signs of serious adverse events such as gastrointestinal bleeding, infections, and respiratory issues. Follow prescribed dosing instructions to minimize the risk of adverse reactions.
Mesalamine has 145,688 adverse event reports on file with the FDA. The most common reactions include diarrhea, abdominal pain, and hematochezia, indicating potential gastrointestinal side effects. The volume of reports for Mesalamine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor mesalamine for safety, and the drug is approved for the treatment of inflammatory bowel diseases. However, healthcare providers should be aware of the potential for serious adverse events and monitor patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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