65/100 · Elevated
Manufactured by Lil' Drug Store Products, Inc.
Moderate Safety Concerns with Ibuprofen Use
598,685 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lil' Drug Store Products, Inc.. Based on analysis of 598,685 FDA adverse event reports, IBUPROFEN 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 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.
Ibuprofen 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 598,685 adverse event reports for this medication, which is primarily manufactured by Lil' Drug Store Products, Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Fatigue. Of classified reports, 64.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ibuprofen reports include a high percentage of serious adverse events, particularly gastrointestinal and respiratory issues.
The most common reactions are pain-related, indicating potential efficacy issues. Serious reactions such as kidney injury and acute kidney injury are reported, warranting caution.
Patients taking Ibuprofen 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 may cause 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 received a safety concern score of 65/100 (elevated concern). This is based on a 64.8% serious event ratio across 262,304 classified reports. The score accounts for 598,685 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: 153,738, Male: 79,870, Unknown: 1,169. The most frequently reported age groups are age 44 (3,993 reports), age 43 (3,447 reports), age 57 (3,332 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 262,304 classified reports for IBUPROFEN:
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 may cause gastrointestinal bleeding. It is contraindicated in patients with known hypersensitivity.
If you are taking Ibuprofen, 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 prescribed dosages and do not exceed recommended limits to avoid serious adverse events. Be aware of potential interactions with other medications and consult a healthcare provider before use. 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 safety, and updates are regularly issued. Patients should report any severe reactions to their healthcare provider.
The FDA has received approximately 598,685 adverse event reports associated with Ibuprofen. 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 include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (24,334 reports), Pain (18,858 reports), Fatigue (17,867 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.
Out of 262,304 classified reports, 169,962 (64.8%) were classified as serious and 92,342 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 break down by patient sex as follows: Female: 153,738, Male: 79,870, Unknown: 1,169. 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 adverse events are: age 44: 3,993 reports, age 43: 3,447 reports, age 57: 3,332 reports, age 58: 3,321 reports, age 59: 3,315 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 adverse event reports is Lil' Drug Store Products, 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 Ibuprofen include: Arthralgia, Dyspnoea, Vomiting, Diarrhoea, Dizziness. 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 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 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. Ibuprofen reports include a high percentage of serious adverse events, particularly gastrointestinal and respiratory issues.
Key safety signals identified in Ibuprofen's adverse event data include: High percentage of serious adverse events (64.8%). Reports of acute kidney injury and renal failure. Multiple respiratory issues including dyspnea and pneumonia. 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 may cause 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.
Follow prescribed dosages and do not exceed recommended limits to avoid serious adverse events. Be aware of potential interactions with other medications and consult a healthcare provider before use.
Ibuprofen has 598,685 adverse event reports on file with the FDA. The most common reactions are pain-related, indicating potential efficacy issues. The volume of reports for Ibuprofen reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor ibuprofen safety, and updates are regularly issued. Patients should report any severe reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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