65/100 · Elevated
Manufactured by Aurobindo Pharma Limited
Moderate Safety Concerns with Ibuprofen Oral
482,782 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN ORAL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Aurobindo Pharma Limited. Based on analysis of 482,782 FDA adverse event reports, IBUPROFEN ORAL 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 ORAL 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 ORAL.
Ibuprofen Oral 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 482,782 adverse event reports for this medication, which is primarily manufactured by Aurobindo Pharma Limited.
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 at a lower frequency. The drug is associated with gastrointestinal issues, including diarrhea and vomiting, which are among the top reactions. There is a notable number of reports related to falls and respiratory issues, suggesting potential risks in certain patient populations.
Patients taking Ibuprofen Oral 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 contraindicated in patients with known hypersensitivity. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibuprofen Oral received a safety concern score of 65/100 (elevated concern). This is based on a 73.0% serious event ratio across 191,723 classified reports. The score accounts for 482,782 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: 111,915, Male: 61,272, Unknown: 600. The most frequently reported age groups are age 44 (3,366 reports), age 43 (2,930 reports), age 59 (2,645 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 191,723 classified reports for IBUPROFEN ORAL:
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 contraindicated in patients with known hypersensitivity.
If you are taking Ibuprofen Oral, 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 duration of use to minimize the risk of adverse effects. Inform your healthcare provider about any pre-existing conditions, especially gastrointestinal issues or kidney disease. 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 or restrictions based on the current data.
The FDA has received approximately 482,782 adverse event reports associated with Ibuprofen Oral. 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 Oral include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (15,239 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 Oral.
Out of 191,723 classified reports, 139,898 (73.0%) were classified as serious and 51,825 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 Oral break down by patient sex as follows: Female: 111,915, Male: 61,272, 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 Oral adverse events are: age 44: 3,366 reports, age 43: 2,930 reports, age 59: 2,645 reports, age 57: 2,527 reports, age 54: 2,522 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 Oral adverse event reports is Aurobindo Pharma Limited. 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 Oral 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 Oral 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 Oral 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 Oral's adverse event data include: Acute kidney injury and drug hypersensitivity are key safety signals, indicating potential severe adverse reactions.. Gastrointestinal issues, including diarrhea and vomiting, are frequent, highlighting the need for caution in patients with pre-existing conditions.. Falls and respiratory issues are significant, especially in older adults, warranting careful monitoring.. 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 contraindicated in patients with known hypersensitivity. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibuprofen Oral.
Always follow the prescribed dosage and duration of use to minimize the risk of adverse effects. Inform your healthcare provider about any pre-existing conditions, especially gastrointestinal issues or kidney disease.
Ibuprofen Oral has 482,782 adverse event reports on file with the FDA. Serious adverse events such as acute kidney injury and drug hypersensitivity are reported, but at a lower frequency. The volume of reports for Ibuprofen Oral 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 or restrictions based on the current data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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