MID-VOLUME · SEX-BALANCED
azelastine Side Effects
azelastine (also sold as Astelin, Astepro) sits MID-VOLUME #257 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 68% of sex-coded reports are female (10,573 F / 4,923 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 16,672
- FAERS reports
FDA Adverse Event Reporting System extract for azelastine. Stamp set WATCHLIST · DEATH-MARKED · HOSP-MID. How figures are compiled.
azelastine reporting skew - 68% of sex-coded reports are female (10,573 F / 4,923 M). Volume band MID-VOLUME #257 of 524 by FAERS report count; caseload WATCHLIST.
Mid-book FAERS page for azelastine (Astelin) (16,672 reports). Signature SEX-BALANCED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2004–2025). Stamps WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
TREATMENT FAILURE leads 1,876 of 16,672 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (2,969 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 522 reports (3.1% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 294 |
| DYSPNOEA | 39 |
| PNEUMONIA | 35 |
| FALL | 24 |
| FATIGUE | 24 |
| CARDIAC ARREST | 21 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 21 |
| SEPSIS | 20 |
| ACUTE KIDNEY INJURY | 19 |
| CEREBROVASCULAR ACCIDENT | 19 |
| ASTHENIA | 18 |
| DIARRHOEA | 18 |
| HYPOTENSION | 18 |
| PYREXIA | 18 |
| RENAL FAILURE | 18 |
| DECREASED APPETITE | 17 |
| WEIGHT DECREASED | 17 |
| MALAISE | 16 |
| NAUSEA | 16 |
| RESPIRATORY FAILURE | 16 |
Reactions in Hospitalization Reports
Hospitalization mid-share (2,849, 17.1%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PNEUMONIA | 375 |
| DYSPNOEA | 286 |
| FATIGUE | 282 |
| NAUSEA | 258 |
| FALL | 251 |
| DIARRHOEA | 231 |
| HEADACHE | 206 |
| PAIN | 195 |
| COUGH | 187 |
| ASTHENIA | 166 |
| DIZZINESS | 166 |
| COVID-19 | 162 |
| SINUSITIS | 159 |
| URINARY TRACT INFECTION | 153 |
| MALAISE | 144 |
| VOMITING | 143 |
| PYREXIA | 142 |
| WEIGHT DECREASED | 142 |
| HOSPITALISATION | 132 |
How to read azelastine FAERS figures (WATCHLIST · DEATH-MARKED · HOSP-MID)
FAERS holds 16,672 voluntary reports linked to azelastine (Astelin, Astepro), 2004-2025. Death is listed on 522 (3.1%). Hospitalization appears on 2,849 (17.1%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-MARKED · HOSP-MID as signal-detection rates next to 68% of sex-coded reports are female (10,573 F / 4,923 M).
Read with azelastine
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 16,403 FAERS cases (Δ 269 lighter vs azelastine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,243 FAERS cases (Δ 429 lighter vs azelastine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,238 FAERS cases (Δ 434 lighter vs azelastine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 16,231 FAERS cases (Δ 441 lighter vs azelastine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's WATCHLIST · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 59.0 pp vs azelastine's DEATH-MARKED): CASELOAD · HOSP-MID.
azelastine stamps WATCHLIST · SEX-BALANCED; class peers and methodology beat restating the same FAERS caveats on every effects URL.