65/100 · Elevated
Manufactured by BETTER LIVING BRANDS, LLC
Moderate Safety Concerns with Ibuprofen Tablets 200mg
482,740 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN TABLETS USP, 200MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BETTER LIVING BRANDS, LLC. Based on analysis of 482,740 FDA adverse event reports, IBUPROFEN TABLETS USP, 200MG 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 USP, 200MG include DRUG INEFFECTIVE, PAIN, FATIGUE, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IBUPROFEN TABLETS USP, 200MG.
Ibuprofen Tablets Usp, 200mg 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 482,740 adverse event reports for this medication, which is primarily manufactured by Better Living Brands, Llc.
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 73.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include pain, fatigue, and nausea, indicating a broad range of mild to moderate side effects.
Serious adverse events such as acute kidney injury and drug hypersensitivity are reported but less frequently. The drug is associated with a variety of gastrointestinal and respiratory issues, suggesting potential risks in these areas. There are significant reports of falls and respiratory tract infections, which could be concerning for elderly patients.
Patients taking Ibuprofen Tablets Usp, 200mg 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. Overdose is a concern and should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibuprofen Tablets Usp, 200mg received a safety concern score of 65/100 (elevated concern). This is based on a 73.0% serious event ratio across 191,666 classified reports. The score accounts for 482,740 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: 111,885, Male: 61,247, Unknown: 600. The most frequently reported age groups are age 44 (3,367 reports), age 43 (2,929 reports), age 59 (2,643 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 191,666 classified reports for IBUPROFEN TABLETS USP, 200MG:
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. Overdose is a concern and should be avoided.
If you are taking Ibuprofen Tablets Usp, 200mg, here are important things to know. The most commonly reported side effects include drug ineffective, pain, fatigue, nausea, headache. 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 do not exceed the recommended limit to avoid adverse effects. Inform your healthcare provider about any existing conditions or medications you are taking to avoid potential drug interactions. 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 and has not issued any specific warnings for this formulation.
The FDA has received approximately 482,740 adverse event reports associated with Ibuprofen Tablets Usp, 200mg. 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 Usp, 200mg include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (15,238 reports), Pain (14,705 reports), Fatigue (14,005 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 Usp, 200mg.
Out of 191,666 classified reports, 139,846 (73.0%) were classified as serious and 51,820 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 Usp, 200mg break down by patient sex as follows: Female: 111,885, Male: 61,247, Unknown: 600. 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 Usp, 200mg adverse events are: age 44: 3,367 reports, age 43: 2,929 reports, age 59: 2,643 reports, age 57: 2,526 reports, age 54: 2,520 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 Usp, 200mg adverse event reports is Better Living Brands, 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 Usp, 200mg include: Arthralgia, Dyspnoea, Vomiting, Diarrhoea, Rash. 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 Usp, 200mg 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 Usp, 200mg 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 pain, fatigue, and nausea, indicating a broad range of mild to moderate side effects.
Key safety signals identified in Ibuprofen Tablets Usp, 200mg's adverse event data include: Acute kidney injury and drug hypersensitivity are key safety signals, though less common.. Falls and respiratory tract infections are notable, especially in older populations.. Drug interactions and overdose are reported, indicating potential risks when combined with other medications.. 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. Overdose is a concern and should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibuprofen Tablets Usp, 200mg.
Always follow the prescribed dosage and do not exceed the recommended limit to avoid adverse effects. Inform your healthcare provider about any existing conditions or medications you are taking to avoid potential drug interactions.
Ibuprofen Tablets Usp, 200mg has 482,740 adverse event reports on file with the FDA. Serious adverse events such as acute kidney injury and drug hypersensitivity are reported but less frequently. The volume of reports for Ibuprofen Tablets Usp, 200mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ibuprofen and has not issued any specific warnings for this formulation. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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