Cetirizine (Reactine) Use During Pregnancy
Cetirizine is considered a safe and appropriate choice for treating allergies during pregnancy, classified as FDA Pregnancy Category B, with no evidence of teratogenicity in humans despite the FDA label's cautionary language.
Evidence-Based Safety Profile
Cetirizine is specifically recommended as a second-generation antihistamine of choice during pregnancy based on multiple authoritative guidelines 1, 2. The drug carries FDA Pregnancy Category B classification, meaning animal studies have not demonstrated fetal risk and adequate human studies have not shown risk to the fetus in the first trimester or later trimesters 1.
Clinical Recommendations by Trimester
All Trimesters
- Cetirizine can be used throughout pregnancy when antihistamine therapy is needed for allergic conditions 1, 2.
- The Journal of Allergy and Clinical Immunology specifically identifies cetirizine alongside loratadine as preferred second-generation antihistamines during pregnancy 1, 3.
- No association with congenital malformations has been documented in human studies 4.
First Trimester Considerations
- While the British Journal of Dermatology guidelines suggest avoiding all antihistamines when possible during the first trimester, they acknowledge that cetirizine has no proven teratogenic effects in humans 1.
- When treatment is necessary, cetirizine remains an acceptable option even in early pregnancy 2, 5.
Preferred Treatment Algorithm
For pregnant patients with allergies, follow this hierarchy:
First-line therapy: Intranasal corticosteroids (budesonide preferred) for allergic rhinitis, as they have superior efficacy and safety data 3, 5.
Second-line or adjunctive therapy: Cetirizine or loratadine when oral antihistamine is needed 1, 3, 2.
Avoid: First-generation antihistamines (despite longer safety records) due to sedating and anticholinergic effects 6, and hydroxyzine which is specifically contraindicated in early pregnancy 1.
Dosing Adjustments
- Renal impairment: Reduce cetirizine dose by half in moderate renal impairment; avoid in severe renal impairment (creatinine clearance <10 mL/min) 1.
- Use the lowest effective dose during pregnancy, as recommended for all medications 1.
Critical Pitfalls to Avoid
- Do not withhold necessary allergy treatment due to pregnancy concerns—uncontrolled allergic conditions and associated asthma pose greater risks to mother and fetus than cetirizine use 2, 5.
- Do not substitute with oral decongestants, especially in the first trimester, as these carry associations with gastroschisis and small intestinal atresia 1, 3, 6.
- Do not use hydroxyzine as an alternative, as it is the only antihistamine specifically contraindicated in early pregnancy 1.
FDA Label Caveat
The FDA label for cetirizine states "ask a health professional before use" during pregnancy 7. This cautionary language reflects regulatory conservatism rather than evidence of harm—the extensive clinical literature and guideline consensus support cetirizine's safety profile 1, 3, 2, 5, 4.
Breastfeeding Considerations
While the FDA label advises against cetirizine use during breastfeeding 7, this recommendation should be weighed against the need for maternal symptom control and discussed with the patient's healthcare provider.