Cetirizine: Side Effects, Uses & Monitoring
Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in
- Data source
- FDA labeling via NIH DailyMed (label 9c6a440b…)
- 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 | 14% |
| Pharyngitis | 6.2% |
| Abdominal pains | 5.6% |
| Coughing | 4.4% |
| Somnolence | 4.2% |
| Epistaxis | 3.7% |
| Diarrhea | 3.1% |
| Bronchospasm | 3.1% |
| Nausea | 2.8% |
| Vomiting | 2.5% |
*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)
Perennial Allergic Rhinitis: Cetirizine Hydrochloride Oral Solution, USP is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in children 6 to 23 months of age. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, ocular pruritus, and tearing. Chronic Urticaria: Cetirizine Hydrochloride Oral Solution, USP is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 5 years of age. It significantly reduces the occurrence, severity, and duration of hives and significantly reduces pruritus.
Conditions associated with Cetirizine in labeling
Frequently Asked Questions
What is Cetirizine 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 Cetirizine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Cetirizine. Individual risk varies.
Does Cetirizine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Cetirizine.
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.