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desloratadine Side Effects

Also known as: Clarinex

Analysis of 10,248 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

10,248

Death-Related

535

5.2% of reports

Hospitalizations

3,888

37.9% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG INEFFECTIVE
605
FATIGUE
601
NAUSEA
582
DYSPNOEA
532
HEADACHE
465
DIARRHOEA
448
DIZZINESS
439
PRURITUS
422
VOMITING
402
RASH
374
PAIN
317
ASTHENIA
316
OFF LABEL USE
316
ARTHRALGIA
312
PYREXIA
309
ACUTE KIDNEY INJURY
303
URTICARIA
294
COUGH
293
MALAISE
274
ANXIETY
260

Who Reports Side Effects

Gender Distribution

Female 6,189 (64%)
Male 3,400 (35%)
Unknown 15

Age Distribution

0-17 676 (9%)
18-44 1,633 (22%)
45-64 2,522 (34%)
65-74 1,332 (18%)
75+ 1,260 (17%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 535 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 114
TOXICITY TO VARIOUS AGENTS 37
ARRHYTHMIA 36
ACUTE KIDNEY INJURY 31
DRUG INTERACTION 31
INTERSTITIAL LUNG DISEASE 30
PNEUMONIA 28
CARDIAC ARREST 27
DYSPNOEA 26
RESPIRATORY FAILURE 26
SUDDEN DEATH 26
CARDIO-RESPIRATORY ARREST 25
INTENTIONAL OVERDOSE 25
MYOCARDIAL INFARCTION 24
OFF LABEL USE 24
RENAL FAILURE 24
PYREXIA 21
SEPTIC SHOCK 21
CONTRAINDICATED PRODUCT ADMINISTERED 19
ELECTROCARDIOGRAM QT PROLONGED 19

Reactions in Hospitalization Reports

Top reactions in 3,888 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 248
NAUSEA 229
VOMITING 221
ACUTE KIDNEY INJURY 188
PYREXIA 186
FATIGUE 185
DIARRHOEA 182
FALL 178
DIZZINESS 161
HYPOTENSION 154
HEADACHE 151
PNEUMONIA 146
ASTHENIA 142
DRUG INEFFECTIVE 138
PRURITUS 138
RASH 137
INTENTIONAL OVERDOSE 133
MALAISE 126
ABDOMINAL PAIN 124
HYPONATRAEMIA 122

Nearby — Related Medications

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What the FAERS Data Reveals About desloratadine Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 10,248 voluntary reports linked to desloratadine and its brand equivalents (Clarinex), spanning 2004 through 2025. Of those, 535 (5.2%) listed death as an outcome and 3,888 (37.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 64% were female and 35% male; age distribution skews toward 45-64, with 2,522 reports in that bracket. The single most reported reaction is drug ineffective with 605 submissions, followed by fatigue and nausea.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.