HIGH-VOLUME · SEX-BALANCED
loratadine Side Effects
loratadine (also sold as Claritin) is HIGH-VOLUME in this FAERS book #73 of 524 by FAERS report count. Signature opener: SEX-BALANCED - 66% of sex-coded reports are female (63,057 F / 32,091 M).
Data updated 2026-05-15
- 104,378
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
loratadine reporting skew - 66% of sex-coded reports are female (63,057 F / 32,091 M). Volume band HIGH-VOLUME #73 of 524 by FAERS report count; caseload MEGA-CASE.
High-report extract for loratadine (Claritin): 104,378 FAERS rows (2003-2025). Top named reactions: FATIGUE, NAUSEA, HEADACHE. Outcome stamps DEATH-MARKED · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
FATIGUE leads 6,414 of 104,378 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (21,289 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 4,537 reports (4.3% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 1,813 |
| PNEUMONIA | 334 |
| DYSPNOEA | 262 |
| SEPSIS | 240 |
| COMPLETED SUICIDE | 232 |
| RENAL FAILURE | 214 |
| CARDIAC ARREST | 209 |
| NAUSEA | 199 |
| FATIGUE | 196 |
| RESPIRATORY FAILURE | 196 |
| ACUTE KIDNEY INJURY | 194 |
| ASTHENIA | 188 |
| DIARRHOEA | 168 |
| CHRONIC KIDNEY DISEASE | 166 |
| TOXICITY TO VARIOUS AGENTS | 164 |
| FALL | 155 |
| PYREXIA | 152 |
| PAIN | 141 |
| MYOCARDIAL INFARCTION | 138 |
Reactions in Hospitalization Reports
Hospitalization mid-share (22,504, 21.6%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PNEUMONIA | 2,006 |
| DYSPNOEA | 1,947 |
| NAUSEA | 1,614 |
| FATIGUE | 1,541 |
| DIARRHOEA | 1,461 |
| PAIN | 1,312 |
| FALL | 1,218 |
| VOMITING | 1,200 |
| PYREXIA | 1,197 |
| HEADACHE | 1,190 |
| ASTHENIA | 1,127 |
| DIZZINESS | 1,049 |
| MALAISE | 875 |
| URINARY TRACT INFECTION | 874 |
| CHEST PAIN | 863 |
| COUGH | 851 |
| ANXIETY | 804 |
| WEIGHT DECREASED | 782 |
| ARTHRALGIA | 738 |
How to read loratadine FAERS figures (MEGA-CASE · DEATH-MARKED · HOSP-MID)
FAERS holds 104,378 voluntary reports linked to loratadine (Claritin), 2003-2025. Death is listed on 4,537 (4.3%). Hospitalization appears on 22,504 (21.6%). 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 loratadine
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 103,356 FAERS cases (Δ 1,022 lighter vs loratadine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 103,354 FAERS cases (Δ 1,024 lighter vs loratadine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 106,440 FAERS cases (Δ 2,062 heavier vs loratadine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 102,306 FAERS cases (Δ 2,072 lighter vs loratadine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-MARKED · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.8 pp vs loratadine's DEATH-MARKED): CASELOAD · HOSP-MID.
loratadine sits in MEGA-CASE; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.