Fexofenadine: Side Effects, Uses & Monitoring
INDICATIONS AND USAGE Seasonal Allergic RhinitisFexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.
- Data source
- FDA labeling via NIH DailyMed (label 9738127d…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Headache | 10.6% |
| Coughing | 3.8% |
| Upper respiratory tract infection | 3.2% |
| Accidental injury | 2.9% |
| Back pain | 2.8% |
| Myalgia | 2.6% |
| Viral infection (cold, flu) | 2.5% |
| Fever | 2.4% |
| Pain | 2.4% |
| Otitis media | 2.4% |
| Nasopharyngitis | 2.4% |
| Dizziness | 2.1% |
| Pain in extremity | 2.1% |
| Nausea | 1.6% |
| Dysmenorrhea | 1.5% |
| Drowsiness | 1.3% |
| Dyspepsia | 1.3% |
| Fatigue | 1.3% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
INDICATIONS AND USAGE Seasonal Allergic RhinitisFexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes. Chronic Idiopathic UrticariaFexofenadine Hydrochloride Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.
Conditions associated with Fexofenadine in labeling
Frequently Asked Questions
What is Fexofenadine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Fexofenadine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Fexofenadine. Individual risk varies.
Does Fexofenadine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Fexofenadine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.