HIGH-VOLUME · SEX-BALANCED
ibuprofen Side Effects
ibuprofen (also sold as Advil, Motrin) is HIGH-VOLUME in this FAERS book #17 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 66% of sex-coded reports are female (153,743 F / 79,875 M).
Data updated 2026-05-15
- 262,453
- FAERS reports
FAERS voluntary reports, 1998 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
ibuprofen reporting skew - 66% of sex-coded reports are female (153,743 F / 79,875 M). Volume band HIGH-VOLUME #17 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for ibuprofen (Advil): 262,453 FAERS rows (1998-2025). Top named reactions: PAIN, FATIGUE, NAUSEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (1998–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
PAIN leads 18,855 of 262,453 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (61,089 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (17,491 reports, 6.7%). Top co-reported reactions in that subset - voluntary, not causal.
| 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 |
| DECREASED APPETITE | 1,100 |
| JOINT SWELLING | 1,085 |
| PYREXIA | 1,074 |
| NAUSEA | 1,061 |
| CONDITION AGGRAVATED | 1,056 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (81,556, 31.1% of the book). Top reactions in those rows:
| 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 |
| ACUTE KIDNEY INJURY | 4,202 |
| DIZZINESS | 4,095 |
| ASTHENIA | 3,732 |
| ABDOMINAL PAIN | 3,647 |
| PNEUMONIA | 3,629 |
| CONDITION AGGRAVATED | 3,570 |
| RASH | 3,497 |
| ANXIETY | 3,486 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 3,451 |
How to read ibuprofen FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 262,453 voluntary reports linked to ibuprofen (Advil, Motrin), 1998-2025. Death is listed on 17,491 (6.7%). Hospitalization appears on 81,556 (31.1%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; SEX-BALANCED is the page opener, not a per-patient risk.
Read with ibuprofen
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 264,092 FAERS cases (Δ 1,639 heavier vs ibuprofen); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 257,862 FAERS cases (Δ 4,591 lighter vs ibuprofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 246,252 FAERS cases (Δ 16,201 lighter vs ibuprofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 245,754 FAERS cases (Δ 16,699 lighter vs ibuprofen); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 55.4 pp vs ibuprofen's DEATH-HEAVY): CASELOAD · HOSP-MID.
ibuprofen stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.