This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Ibuprofen Oral

nonsteroidal anti-inflammatory drug

Last updated: June 21, 2026

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Ibuprofen Oral is a medication, a nonsteroidal anti-inflammatory drug. According to the FDA-approved label, (S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever. FAERS contains 195,086 submissions naming this drug from 1998 through 2026; the top three reactions cited are drug ineffective, pain, and fatigue.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Ibuprofen Oral. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

Patient Demographics

Patient sex and age across the FAERS submissions that named Ibuprofen Oral. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

By Age Group

Severity Outcomes

Severity flags recorded across the 195,086 FAERS submissions that named Ibuprofen Oral. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

Submissions Per Quarter

Quarterly count of FAERS submissions that named Ibuprofen Oral. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Ibuprofen Oral. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

(S) temporarily: relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache reduces fever

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if your child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

FDA label effective date: 2025-05-12

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.