65/100 · Elevated
Manufactured by AMERISOURCE BERGEN
Ibuprofen Safety Profile: Common Mild Reactions, Serious Events Include Renal and Gastrointestinal Issues
482,732 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPFROFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AMERISOURCE BERGEN. Based on analysis of 482,732 FDA adverse event reports, IBUPFROFEN 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 IBUPFROFEN 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 IBUPFROFEN.
Ibupfrofen 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 482,732 adverse event reports for this medication, which is primarily manufactured by Amerisource Bergen.
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. Most common reactions are mild and include pain, fatigue, and nausea.
Serious events such as acute kidney injury and gastrointestinal issues are reported but less frequent. The majority of reactions are non-serious, with the most common being pain and fatigue. Drug interactions and overdose are reported but not as frequently as other reactions. The safety profile is generally stable, with no significant increase in serious adverse events.
Patients taking Ibupfrofen should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ibuprofen can interact with other medications, and patients should be cautious about overuse, which can lead to serious gastrointestinal and renal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibupfrofen received a safety concern score of 65/100 (elevated concern). This is based on a 73.0% serious event ratio across 191,663 classified reports. The score accounts for 482,732 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: 111,884, Male: 61,245, Unknown: 600. The most frequently reported age groups are age 44 (3,366 reports), age 43 (2,928 reports), age 59 (2,643 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 191,663 classified reports for IBUPFROFEN:
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 medications, and patients should be cautious about overuse, which can lead to serious gastrointestinal and renal issues.
If you are taking Ibupfrofen, 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. Follow the prescribed dosage and duration of use to minimize the risk of adverse reactions. Be aware of potential interactions with other medications and consult a healthcare provider if you have any concerns. 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 Ibuprofen's safety, and regulatory actions may be taken if serious adverse events increase.
The FDA has received approximately 482,732 adverse event reports associated with Ibupfrofen. 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 Ibupfrofen include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (15,237 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 Ibupfrofen.
Out of 191,663 classified reports, 139,843 (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 Ibupfrofen break down by patient sex as follows: Female: 111,884, Male: 61,245, 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 Ibupfrofen adverse events are: age 44: 3,366 reports, age 43: 2,928 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 Ibupfrofen adverse event reports is Amerisource Bergen. 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 Ibupfrofen 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 Ibupfrofen 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.
Ibupfrofen 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. Most common reactions are mild and include pain, fatigue, and nausea.
Key safety signals identified in Ibupfrofen's adverse event data include: Acute kidney injury is a key safety signal, with 6,465 reports.. Gastrointestinal issues, including ulcers and perforation, are also significant, with 2,763 reports.. Drug interactions and overdose are notable, with 2,958 and 3,234 reports respectively.. Renal failure and hypertension are also important signals, with 3,547 and 4,057 reports respectively.. 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 medications, and patients should be cautious about overuse, which can lead to serious gastrointestinal and renal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibupfrofen.
Follow the prescribed dosage and duration of use to minimize the risk of adverse reactions. Be aware of potential interactions with other medications and consult a healthcare provider if you have any concerns.
Ibupfrofen has 482,732 adverse event reports on file with the FDA. Serious events such as acute kidney injury and gastrointestinal issues are reported but less frequent. The volume of reports for Ibupfrofen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Ibuprofen's safety, and regulatory actions may be taken if serious adverse events increase. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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