65/100 · Elevated
Manufactured by ADVANCED FIRST AID, INC.
Moderate Safety Concerns with Ibuprofen 200mg Based on Adverse Event Data
482,960 FDA adverse event reports analyzed
Last updated: 2026-05-12
IBUPROFEN 200MG is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ADVANCED FIRST AID, INC.. Based on analysis of 482,960 FDA adverse event reports, IBUPROFEN 200MG 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 200MG 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 200MG.
Ibuprofen 200mg 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 482,960 adverse event reports for this medication, which is primarily manufactured by Advanced First Aid, 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. The reaction diversity is high, with over 100 distinct reactions reported, suggesting a complex safety profile. The majority of reactions are non-serious, but the volume of reports is substantial, indicating potential widespread use and exposure.
Patients taking Ibuprofen 200mg should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ibuprofen 200mg can interact with other NSAIDs and may exacerbate gastrointestinal issues. Patients should avoid concurrent use and consult a healthcare provider for guidance. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ibuprofen 200mg received a safety concern score of 65/100 (elevated concern). This is based on a 73.0% serious event ratio across 191,840 classified reports. The score accounts for 482,960 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: 111,994, Male: 61,303, Unknown: 600. The most frequently reported age groups are age 44 (3,367 reports), age 43 (2,931 reports), age 59 (2,649 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 191,840 classified reports for IBUPROFEN 200MG:
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 200mg can interact with other NSAIDs and may exacerbate gastrointestinal issues. Patients should avoid concurrent use and consult a healthcare provider for guidance.
If you are taking Ibuprofen 200mg, 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 as directed by a healthcare provider. Be aware of potential interactions with other medications and report any unusual symptoms to a healthcare professional. 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 regulatory actions may be taken based on emerging data.
The FDA has received approximately 482,960 adverse event reports associated with Ibuprofen 200mg. 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 200mg include Drug Ineffective, Pain, Fatigue, Nausea, Headache. By volume, the top reported reactions are: Drug Ineffective (15,246 reports), Pain (14,708 reports), Fatigue (14,012 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 200mg.
Out of 191,840 classified reports, 139,976 (73.0%) were classified as serious and 51,864 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 200mg break down by patient sex as follows: Female: 111,994, Male: 61,303, 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 200mg adverse events are: age 44: 3,367 reports, age 43: 2,931 reports, age 59: 2,649 reports, age 57: 2,528 reports, age 58: 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 200mg adverse event reports is Advanced First Aid, 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 200mg 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 200mg 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 200mg 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 200mg's adverse event data include: Acute kidney injury and drug hypersensitivity are key safety signals, though less frequent.. A high number of gastrointestinal reactions, including diarrhea and vomiting, are reported.. The presence of serious reactions like pneumonia and chronic kidney disease is notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ibuprofen 200mg can interact with other NSAIDs and may exacerbate gastrointestinal issues. Patients should avoid concurrent use and consult a healthcare provider for guidance. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ibuprofen 200mg.
Always follow the prescribed dosage and duration of use as directed by a healthcare provider. Be aware of potential interactions with other medications and report any unusual symptoms to a healthcare professional.
Ibuprofen 200mg has 482,960 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 200mg reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of ibuprofen, and regulatory actions may be taken based on emerging data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with IBUPROFEN 200MG:
Drugs related to IBUPROFEN 200MG based on therapeutic use, drug class, or shared indications: