HIGH-VOLUME · FEMALE-LED
omalizumab Side Effects
omalizumab (also sold as Xolair) is HIGH-VOLUME in this FAERS book #94 of 524 by FAERS report count. Signature opener: FEMALE-LED - 74% of sex-coded reports are female (52,705 F / 18,979 M).
Data updated 2026-05-15
- 79,748
- FAERS reports
FAERS voluntary reports, 2004 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
omalizumab reporting skew - 74% of sex-coded reports are female (52,705 F / 18,979 M). Volume band HIGH-VOLUME #94 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for omalizumab (Xolair): 79,748 FAERS rows (2004-2025). Top named reactions: ASTHMA, URTICARIA, DYSPNOEA. Outcome stamps DEATH-MARKED · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2004–2025). Stamps CASELOAD · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ASTHMA leads 11,601 of 79,748 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (74% of sex-coded rows)
Age peak 45-64 (15,541 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 2,390 reports (3.0% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 1,455 |
| ASTHMA | 301 |
| PNEUMONIA | 179 |
| DYSPNOEA | 165 |
| MALAISE | 129 |
| FATIGUE | 111 |
| ASTHENIA | 101 |
| COUGH | 99 |
| MYOCARDIAL INFARCTION | 86 |
| WHEEZING | 85 |
| HEART RATE INCREASED | 81 |
| WEIGHT DECREASED | 81 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 67 |
| FALL | 67 |
| FORCED EXPIRATORY VOLUME DECREASED | 63 |
| LUNG DISORDER | 61 |
| HEADACHE | 60 |
| RESPIRATORY FAILURE | 59 |
Reactions in Hospitalization Reports
Hospitalization mid-share (15,129, 19.0%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| ASTHMA | 5,346 |
| DYSPNOEA | 4,226 |
| COUGH | 3,043 |
| PNEUMONIA | 2,699 |
| MALAISE | 2,262 |
| WHEEZING | 2,208 |
| FATIGUE | 2,039 |
| URTICARIA | 1,872 |
| HEADACHE | 1,727 |
| WEIGHT DECREASED | 1,613 |
| NASOPHARYNGITIS | 1,605 |
| PYREXIA | 1,573 |
| PRURITUS | 1,338 |
| PAIN | 1,320 |
| CHEST DISCOMFORT | 1,313 |
| INFLUENZA | 1,307 |
| PRODUCTIVE COUGH | 1,285 |
| BLOOD PRESSURE INCREASED | 1,234 |
| HYPERSENSITIVITY | 1,216 |
How to read omalizumab FAERS figures (CASELOAD · DEATH-MARKED · HOSP-MID)
FAERS holds 79,748 voluntary reports linked to omalizumab (Xolair), 2004-2025. Death is listed on 2,390 (3.0%). Hospitalization appears on 15,129 (19.0%). Top co-reported indication: Asthma.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with omalizumab
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-MID stamps.
ABS(total_reports) peer at 78,359 FAERS cases (Δ 1,389 lighter vs omalizumab); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 82,165 FAERS cases (Δ 2,417 heavier vs omalizumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 82,622 FAERS cases (Δ 2,874 heavier vs omalizumab); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 76,270 FAERS cases (Δ 3,478 lighter vs omalizumab); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-MARKED · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.1 pp vs omalizumab's DEATH-MARKED): CASELOAD · HOSP-MID.
omalizumab sits in CASELOAD; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.