65/100 · Elevated
Manufactured by Haleon US Holdings LLC
Moderate Safety Concerns with Ibuprofen Sodium
83,045 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Haleon US Holdings LLC. Based on analysis of 83,045 FDA adverse event reports, IBUPROFEN SODIUM 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 SODIUM 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 SODIUM.
Ibuprofen Sodium 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 83,045 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, 39.5% 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 dyspnea, fall, and death, account for nearly 40% of serious reports, highlighting significant risks. The reaction diversity is high, with over 100 distinct reactions reported, suggesting a complex safety profile. The majority of reports are non-serious, but the volume of serious events is concerning.
Patients taking Ibuprofen Sodium should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ibuprofen sodium can interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. It is also contraindicated in patients with severe renal impairment or asthma triggered by aspirin. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibuprofen Sodium received a safety concern score of 65/100 (elevated concern). This is based on a 39.5% serious event ratio across 41,807 classified reports. The score accounts for 83,045 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: 24,533, Male: 10,443, Unknown: 469. The most frequently reported age groups are age 53 (551 reports), age 62 (523 reports), age 57 (522 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,807 classified reports for IBUPROFEN SODIUM:
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 sodium can interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. It is also contraindicated in patients with severe renal impairment or asthma triggered by aspirin.
If you are taking Ibuprofen Sodium, 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 adverse effects. Be cautious when using ibuprofen with other NSAIDs to prevent gastrointestinal complications. 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 sodium. Healthcare providers should be vigilant about potential serious adverse events and consider alternative treatments for patients with a history of severe reactions.
The FDA has received approximately 83,045 adverse event reports associated with Ibuprofen Sodium. 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 Sodium include Drug Ineffective, Fatigue, Nausea, Headache, Pain. By volume, the top reported reactions are: Drug Ineffective (6,667 reports), Fatigue (2,646 reports), Nausea (2,581 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 Sodium.
Out of 41,807 classified reports, 16,499 (39.5%) were classified as serious and 25,308 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 Sodium break down by patient sex as follows: Female: 24,533, Male: 10,443, 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 Sodium adverse events are: age 53: 551 reports, age 62: 523 reports, age 57: 522 reports, age 56: 515 reports, age 58: 493 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 Sodium 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 Sodium 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 Sodium 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 Sodium 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 Sodium's adverse event data include: Serious adverse events like dyspnea, fall, and death are reported.. A wide range of reactions, including gastrointestinal issues and musculoskeletal symptoms, are common.. Overdose and intentional misuse are reported, indicating potential misuse issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ibuprofen sodium can interact with other NSAIDs, increasing the risk of gastrointestinal bleeding. It is also contraindicated in patients with severe renal impairment or asthma triggered by aspirin. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibuprofen Sodium.
Follow the prescribed dosage and do not exceed the recommended limit to avoid adverse effects. Be cautious when using ibuprofen with other NSAIDs to prevent gastrointestinal complications.
Ibuprofen Sodium has 83,045 adverse event reports on file with the FDA. Serious adverse events, such as dyspnea, fall, and death, account for nearly 40% of serious reports, highlighting significant risks. The volume of reports for Ibuprofen Sodium reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ibuprofen sodium. Healthcare providers should be vigilant about potential serious adverse events and consider alternative treatments for patients with a history of severe reactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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