MID-VOLUME · FEMALE-LED
pseudoephedrine Side Effects
pseudoephedrine (also sold as Sudafed) sits MID-VOLUME #326 of 524 by FAERS report count. Lead signal: FEMALE-LED - 92% of sex-coded reports are female (7,126 F / 594 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 9,450
- FAERS reports
FDA Adverse Event Reporting System extract for pseudoephedrine. Stamp set WATCHLIST · DEATH-HEAVY · HOSP-HEAVY. How figures are compiled.
pseudoephedrine reporting skew - 92% of sex-coded reports are female (7,126 F / 594 M). Volume band MID-VOLUME #326 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for pseudoephedrine (Sudafed) (9,450 reports). Signature FEMALE-LED. Dominant age band on file: 18-44. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
SYSTEMIC LUPUS ERYTHEMATOSUS leads 5,062 of 9,450 reports
FEMALE-LED reporters · age peak 18-44
Female-led reporters (92% of sex-coded rows)
Age peak 18-44 (3,647 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (3,156 reports, 33.4%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,408 |
| TYPE 2 DIABETES MELLITUS | 1,404 |
| WOUND | 1,385 |
| SYNOVITIS | 1,371 |
| RHEUMATOID ARTHRITIS | 1,367 |
| RASH | 1,338 |
| PSORIATIC ARTHROPATHY | 1,333 |
| SWELLING | 1,283 |
| PERICARDITIS | 1,275 |
| INFUSION RELATED REACTION | 1,272 |
| PEMPHIGUS | 1,271 |
| GLOSSODYNIA | 1,260 |
| JOINT SWELLING | 1,253 |
| HAND DEFORMITY | 1,251 |
| PAIN | 1,230 |
| DUODENAL ULCER PERFORATION | 1,195 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,189 |
| FIBROMYALGIA | 1,171 |
| ABDOMINAL DISCOMFORT | 1,160 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (3,766, 39.9% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 1,895 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,868 |
| SYNOVITIS | 1,813 |
| SWELLING | 1,773 |
| RASH | 1,748 |
| PEMPHIGUS | 1,727 |
| PAIN | 1,725 |
| PERICARDITIS | 1,725 |
| ABDOMINAL DISCOMFORT | 1,722 |
| WOUND | 1,694 |
| INFUSION RELATED REACTION | 1,657 |
| GLOSSODYNIA | 1,646 |
| JOINT SWELLING | 1,642 |
| ALOPECIA | 1,637 |
| FATIGUE | 1,636 |
| HAND DEFORMITY | 1,631 |
| HEPATIC ENZYME INCREASED | 1,608 |
| DUODENAL ULCER PERFORATION | 1,554 |
How to read pseudoephedrine FAERS figures (WATCHLIST · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 9,450 voluntary reports linked to pseudoephedrine (Sudafed), 2004-2025. Death is listed on 3,156 (33.4%). Hospitalization appears on 3,766 (39.9%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-HEAVY · HOSP-HEAVY as signal-detection rates next to 92% of sex-coded reports are female (7,126 F / 594 M).
Read with pseudoephedrine
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 9,400 FAERS cases (Δ 50 lighter vs pseudoephedrine); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,536 FAERS cases (Δ 86 heavier vs pseudoephedrine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,259 FAERS cases (Δ 191 lighter vs pseudoephedrine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 9,140 FAERS cases (Δ 310 lighter vs pseudoephedrine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 0.0% death-mentioned reports (Δ 33.4 pp vs pseudoephedrine's DEATH-HEAVY): MEGA-CASE · HOSP-LIGHT.
pseudoephedrine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload WATCHLIST and the label guide.