65/100 · Elevated
Manufactured by Haleon US Holdings LLC
Moderate Safety Concerns with Ibuprofen Tablets, Coated
82,355 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN TABLETS, COATED is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 82,355 FDA adverse event reports, IBUPROFEN TABLETS, COATED 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 IBUPROFEN TABLETS, COATED include DRUG INEFFECTIVE, FATIGUE, NAUSEA, HEADACHE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBUPROFEN TABLETS, COATED.
Ibuprofen Tablets, Coated 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 82,355 adverse event reports for this medication, which is primarily manufactured by Haleon Us Holdings Llc.
The most commonly reported adverse events include Drug Ineffective, Fatigue, Nausea. Of classified reports, 39.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include fatigue, nausea, and headache, indicating a broad range of mild to moderate side effects.
Serious adverse events, such as dyspnoea and falls, account for nearly 40% of serious reports, highlighting potential risks. A significant number of reports involve off-label use and misuse, suggesting potential misuse issues. The majority of reactions are non-serious, but the diversity of reactions indicates a complex safety profile.
Patients taking Ibuprofen Tablets, Coated should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ibuprofen can interact with other NSAIDs and increase the risk of gastrointestinal bleeding. It is important to avoid concurrent use with other NSAIDs and to follow dosage instructions carefully. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibuprofen Tablets, Coated received a safety concern score of 65/100 (elevated concern). This is based on a 39.3% serious event ratio across 41,492 classified reports. The score accounts for 82,355 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: 24,301, Male: 10,381, Unknown: 469. The most frequently reported age groups are age 53 (545 reports), age 57 (520 reports), age 56 (515 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,492 classified reports for IBUPROFEN TABLETS, COATED:
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.
Ibuprofen can interact with other NSAIDs and increase the risk of gastrointestinal bleeding. It is important to avoid concurrent use with other NSAIDs and to follow dosage instructions carefully.
If you are taking Ibuprofen Tablets, Coated, here are important things to know. The most commonly reported side effects include drug ineffective, fatigue, nausea, headache, pain. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow the prescribed dosage and do not exceed the recommended limit to avoid side effects. Be cautious when using ibuprofen for off-label purposes and consult a healthcare provider before doing so. 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 the safety of ibuprofen. Healthcare providers should be vigilant about potential serious adverse events and monitor patients for signs of misuse or off-label use.
The FDA has received approximately 82,355 adverse event reports associated with Ibuprofen Tablets, Coated. 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 Ibuprofen Tablets, Coated include Drug Ineffective, Fatigue, Nausea, Headache, Pain. By volume, the top reported reactions are: Drug Ineffective (6,617 reports), Fatigue (2,627 reports), Nausea (2,559 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ibuprofen Tablets, Coated.
Out of 41,492 classified reports, 16,289 (39.3%) were classified as serious and 25,203 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 Ibuprofen Tablets, Coated break down by patient sex as follows: Female: 24,301, Male: 10,381, Unknown: 469. 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 Ibuprofen Tablets, Coated adverse events are: age 53: 545 reports, age 57: 520 reports, age 56: 515 reports, age 62: 506 reports, age 58: 492 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 Ibuprofen Tablets, Coated 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 Ibuprofen Tablets, Coated include: Diarrhoea, Dizziness, Product Use In Unapproved Indication, Arthralgia, Dyspnoea. 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 Ibuprofen Tablets, Coated 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.
Ibuprofen Tablets, Coated 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 most common reactions include fatigue, nausea, and headache, indicating a broad range of mild to moderate side effects.
Key safety signals identified in Ibuprofen Tablets, Coated's adverse event data include: Falls and dyspnoea are among the more serious reactions reported.. Off-label use and misuse are common, indicating potential misuse issues.. A wide range of reactions, including gastrointestinal and neurological symptoms, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ibuprofen can interact with other NSAIDs and increase the risk of gastrointestinal bleeding. It is important to avoid concurrent use with other NSAIDs and to follow dosage instructions carefully. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibuprofen Tablets, Coated.
Follow the prescribed dosage and do not exceed the recommended limit to avoid side effects. Be cautious when using ibuprofen for off-label purposes and consult a healthcare provider before doing so.
Ibuprofen Tablets, Coated has 82,355 adverse event reports on file with the FDA. Serious adverse events, such as dyspnoea and falls, account for nearly 40% of serious reports, highlighting potential risks. The volume of reports for Ibuprofen Tablets, Coated reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ibuprofen. Healthcare providers should be vigilant about potential serious adverse events and monitor patients for signs of misuse or off-label use. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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