ibuprofen Side Effects
Also known as: Advil, Motrin
Analysis of 262,453 adverse event reports submitted to the FDA from 1998 to 2025.
Total Reports
262,453
Death-Related
17,491
6.7% of reports
Hospitalizations
81,556
31.1% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 17,491 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 3,732 |
| COMPLETED SUICIDE | 2,896 |
| TOXICITY TO VARIOUS AGENTS | 2,220 |
| FATIGUE | 1,425 |
| PAIN | 1,404 |
| DIARRHOEA | 1,347 |
| VOMITING | 1,326 |
| DYSPNOEA | 1,299 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,245 |
| ARTHRALGIA | 1,179 |
| HYPERTENSION | 1,150 |
| CONFUSIONAL STATE | 1,126 |
| PNEUMONIA | 1,123 |
| RASH | 1,103 |
| OFF LABEL USE | 1,101 |
| DECREASED APPETITE | 1,100 |
| JOINT SWELLING | 1,085 |
| PYREXIA | 1,074 |
| NAUSEA | 1,061 |
| CONDITION AGGRAVATED | 1,056 |
Reactions in Hospitalization Reports
Top reactions in 81,556 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PAIN | 7,117 |
| NAUSEA | 6,637 |
| VOMITING | 6,429 |
| DYSPNOEA | 5,685 |
| FATIGUE | 5,524 |
| PYREXIA | 4,962 |
| HEADACHE | 4,888 |
| DIARRHOEA | 4,741 |
| ARTHRALGIA | 4,271 |
| DRUG INEFFECTIVE | 4,210 |
| ACUTE KIDNEY INJURY | 4,202 |
| DIZZINESS | 4,095 |
| ASTHENIA | 3,732 |
| OFF LABEL USE | 3,668 |
| ABDOMINAL PAIN | 3,647 |
| PNEUMONIA | 3,629 |
| CONDITION AGGRAVATED | 3,570 |
| RASH | 3,497 |
| ANXIETY | 3,486 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3,451 |
Nearby — Related Medications
What the FAERS Data Reveals About ibuprofen Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 262,453 voluntary reports linked to ibuprofen and its brand equivalents (Advil, Motrin), spanning 1998 through 2025. Of those, 17,491 (6.7%) listed death as an outcome and 81,556 (31.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 65% were female and 34% male; age distribution skews toward 45-64, with 61,089 reports in that bracket. The single most reported reaction is drug ineffective with 24,335 submissions, followed by pain and fatigue.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.