DESLORATADINE

N/A

Manufactured by Organon LLC

19,228 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DESLORATADINE

DESLORATADINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Organon LLC. The most commonly reported adverse reactions for DESLORATADINE include DRUG INEFFECTIVE, FATIGUE, NAUSEA, DYSPNOEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DESLORATADINE.

Top Adverse Reactions

DRUG INEFFECTIVE605 reports
FATIGUE601 reports
NAUSEA582 reports
DYSPNOEA533 reports
HEADACHE466 reports
DIARRHOEA449 reports
DIZZINESS440 reports
PRURITUS422 reports
VOMITING402 reports
RASH374 reports
PAIN320 reports
ASTHENIA318 reports
OFF LABEL USE316 reports
ARTHRALGIA313 reports
PYREXIA309 reports
ACUTE KIDNEY INJURY303 reports
URTICARIA294 reports
COUGH293 reports
MALAISE274 reports
ANXIETY260 reports
FALL256 reports
ABDOMINAL PAIN253 reports
SOMNOLENCE244 reports
INSOMNIA240 reports
WEIGHT DECREASED232 reports
PAIN IN EXTREMITY231 reports
PNEUMONIA225 reports
HYPERSENSITIVITY219 reports
ERYTHEMA217 reports
HYPOTENSION216 reports
MYALGIA216 reports
ABDOMINAL PAIN UPPER214 reports
DEPRESSION211 reports
ASTHMA209 reports
HYPERTENSION205 reports
INTENTIONAL OVERDOSE199 reports
CONDITION AGGRAVATED197 reports
WEIGHT INCREASED196 reports
DRUG INTERACTION187 reports
BACK PAIN184 reports
CONSTIPATION180 reports
CHEST PAIN175 reports
ANGIOEDEMA170 reports
FEELING ABNORMAL169 reports
MUSCLE SPASMS165 reports
PRODUCT USE IN UNAPPROVED INDICATION161 reports
CONFUSIONAL STATE159 reports
DECREASED APPETITE150 reports
PARAESTHESIA143 reports
HYPONATRAEMIA138 reports
HYPERHIDROSIS135 reports
GAIT DISTURBANCE134 reports
SYNCOPE134 reports
TOXICITY TO VARIOUS AGENTS133 reports
DYSPEPSIA132 reports
CHRONIC KIDNEY DISEASE130 reports
TREMOR129 reports
SINUSITIS128 reports
CHEST DISCOMFORT127 reports
DRUG HYPERSENSITIVITY127 reports
ANAEMIA126 reports
TACHYCARDIA126 reports
OEDEMA PERIPHERAL123 reports
URINARY TRACT INFECTION123 reports
RENAL FAILURE122 reports
PALPITATIONS121 reports
HEART RATE INCREASED119 reports
ABDOMINAL DISTENSION114 reports
DEATH114 reports
ABDOMINAL DISCOMFORT112 reports
ARRHYTHMIA109 reports
GASTROOESOPHAGEAL REFLUX DISEASE108 reports
SUICIDAL IDEATION108 reports
SUICIDE ATTEMPT107 reports
MUSCULAR WEAKNESS106 reports
ALOPECIA105 reports
CONTUSION105 reports
DEHYDRATION105 reports
EPISTAXIS101 reports
NASOPHARYNGITIS100 reports
HYPOAESTHESIA99 reports
MYOCARDIAL INFARCTION94 reports
NO ADVERSE EVENT94 reports
BRONCHITIS93 reports
JOINT SWELLING93 reports
PULMONARY EMBOLISM93 reports
GENERAL PHYSICAL HEALTH DETERIORATION92 reports
MIGRAINE92 reports
THROMBOCYTOPENIA92 reports
WHEEZING92 reports
BLOOD CHOLESTEROL INCREASED91 reports
CEREBROVASCULAR ACCIDENT91 reports
LOSS OF CONSCIOUSNESS91 reports
CHILLS90 reports
AGITATION89 reports
BLOOD GLUCOSE INCREASED89 reports
DYSPHAGIA89 reports
FLUSHING89 reports
HYPERKALAEMIA89 reports
BLOOD PRESSURE INCREASED88 reports

Report Outcomes

Out of 10,250 classified reports for DESLORATADINE:

Serious 77.5%Non-Serious 22.5%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female6,190 (64.4%)
Male3,401 (35.4%)
Unknown15 (0.2%)

Reports by Age

Age 63222 reports
Age 74166 reports
Age 50163 reports
Age 54154 reports
Age 67152 reports
Age 60151 reports
Age 65148 reports
Age 66142 reports
Age 62137 reports
Age 77137 reports
Age 52136 reports
Age 61135 reports
Age 56134 reports
Age 64129 reports
Age 75128 reports
Age 59125 reports
Age 68124 reports
Age 70124 reports
Age 55123 reports
Age 69123 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DESLORATADINE?

This profile reflects 19,228 FDA FAERS reports that mention DESLORATADINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DESLORATADINE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FATIGUE, NAUSEA, DYSPNOEA, HEADACHE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DESLORATADINE?

Labeling and FAERS entries often list Organon LLC in connection with DESLORATADINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.