65/100 · Elevated
Manufactured by -Sun Pharmaceutical Industries, Inc.
Moderate Safety Concerns with Ibuprofen Capsule
482,730 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN CAPSULE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by -Sun Pharmaceutical Industries, Inc.. Based on analysis of 482,730 FDA adverse event reports, IBUPROFEN CAPSULE 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 CAPSULE 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 CAPSULE.
Ibuprofen Capsule 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 482,730 adverse event reports for this medication, which is primarily manufactured by -Sun Pharmaceutical Industries, Inc..
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 reactions such as acute kidney injury and drug hypersensitivity are reported, but less frequently. There is a notable increase in gastrointestinal and respiratory issues, suggesting potential risks in these areas. The drug is often used off-label, which may contribute to the higher number of adverse events reported.
Patients taking Ibuprofen Capsule 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 Capsule received a safety concern score of 65/100 (elevated concern). This is based on a 73.0% serious event ratio across 191,661 classified reports. The score accounts for 482,730 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: 111,882, 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 191,661 classified reports for IBUPROFEN CAPSULE:
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 Capsule, 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. Be aware of potential interactions with other medications and inform your healthcare provider of all medications you are taking. 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 recalls. However, patients should report any severe or unusual side effects to their healthcare provider.
The FDA has received approximately 482,730 adverse event reports associated with Ibuprofen Capsule. 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 Capsule 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 Ibuprofen Capsule.
Out of 191,661 classified reports, 139,842 (73.0%) were classified as serious and 51,819 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 Capsule break down by patient sex as follows: Female: 111,882, 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 Ibuprofen Capsule 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 Ibuprofen Capsule adverse event reports is -Sun Pharmaceutical Industries, 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 Capsule 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 Capsule 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 Capsule 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 Capsule's adverse event data include: Acute kidney injury and drug hypersensitivity are key safety signals, indicating potential severe adverse reactions.. A significant number of reports involve gastrointestinal issues, including diarrhea and vomiting.. Respiratory issues such as dyspnea and pneumonia are also common, suggesting potential risks in this area.. 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 Capsule.
Always follow the prescribed dosage and duration of use. Be aware of potential interactions with other medications and inform your healthcare provider of all medications you are taking.
Ibuprofen Capsule has 482,730 adverse event reports on file with the FDA. Serious reactions such as acute kidney injury and drug hypersensitivity are reported, but less frequently. The volume of reports for Ibuprofen Capsule 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 recalls. However, patients should report any severe or unusual side effects 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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