Zyrtec (Cetirizine) Use in Children Under 2 Years
Zyrtec is NOT FDA-approved for children under 6 years of age and should not be used in children under 2 without consulting a physician. 1
FDA-Approved Age Restrictions
The FDA drug label for cetirizine explicitly states that for children under 6 years of age, parents should "Ask a doctor" before administering the medication. 1 This means:
- Children under 6 years: Requires physician consultation before use 1
- Children 6 years and older: Can use 10 mg tablet once daily 1
- No established dosing exists for over-the-counter use in children under 6 years 1
Safety Profile in Young Children
Despite the FDA labeling restrictions for OTC use, clinical evidence demonstrates that second-generation antihistamines like cetirizine have been studied in young children:
- Well-tolerated safety profile: Cetirizine has been shown to be well tolerated with a very good safety profile when used in young children in clinical studies 2
- Infants 6-24 months: The tolerability profile was similar to placebo in this age group 3
- No cognitive effects: Cetirizine did not adversely affect cognitive function, behavior, or achievement of psychomotor milestones in pediatric patients 3
Clinical Evidence in Children Ages 2-6 Years
Research has demonstrated efficacy in the 2-6 year age range:
- A study of 47 children aged 2-6 years with allergic rhinitis showed excellent improvement with cetirizine 5 mg daily for 3 weeks, with good tolerance 4
- Cetirizine was effective in children aged 2-11 years for seasonal and perennial allergic rhinitis 3
Important Safety Considerations
Overdose Risk
- A case report documented a 4-year-old who accidentally ingested a 12-fold overdose (60 mg) experienced severe drowsiness and lethargy but fully recovered within 5-6 hours without treatment 5
- Drowsiness and sedation are the primary expected side effects in overdose situations 5
Contrast with OTC Cold Medications
- Unlike first-generation antihistamines (diphenhydramine, brompheniramine, chlorpheniramine) which have been associated with fatalities in young children, second-generation antihistamines like cetirizine have demonstrated superior safety 2
- The FDA and advisory committees have raised significant concerns about OTC cough and cold medications in children under 6 years due to toxicity risks, but specifically noted that second-generation antihistamines like cetirizine have a better safety profile 2
Clinical Recommendation
For children under 2 years old, cetirizine should only be used under direct physician supervision with appropriate weight-based dosing. The lack of FDA approval for OTC use in this age group reflects the need for medical oversight rather than an absolute contraindication. 1 If a physician determines cetirizine is appropriate for a child under 2 years, they must: