Levocetirizine
MedicationAntihistamine
Research strength: 2 / 5
FDA labeling says the human data on levocetirizine are too limited to identify risks of miscarriage, birth defects, or other pregnancy outcomes. A 2023 international questionnaire study of 288 people with chronic hives found no link between patient, disease, or treatment factors and medical problems at birth, but its abstract does not report a levocetirizine-only result. UK product information says levocetirizine may be considered during pregnancy if needed, while noting limited data for this medicine itself. The direct evidence for levocetirizine remains limited. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Levocetirizine dihydrochloride tabletsDrug company label
- Kocatürk et al., PREG-CU studyUS government
- UK Summary of Product Characteristics: Levocetirizine
Research strength: 2 / 5
FDA labeling says the human data on levocetirizine are too limited to identify risks of miscarriage, birth defects, or other pregnancy outcomes, and it gives no second-trimester estimate. A 2023 international questionnaire study of 288 people with chronic hives found no link between patient, disease, or treatment factors and medical problems at birth, but its abstract does not report levocetirizine-only or trimester-specific results. UK product information says levocetirizine may be considered during pregnancy if needed, while noting limited data for this medicine itself. The direct evidence for mid-pregnancy remains limited. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Levocetirizine dihydrochloride tabletsDrug company label
- Kocatürk et al., PREG-CU studyUS government
- UK Summary of Product Characteristics: Levocetirizine
Research strength: 2 / 5
FDA labeling says the human data on levocetirizine are too limited to identify risks of miscarriage, birth defects, or other pregnancy outcomes, and it gives no third-trimester estimate. A 2023 international questionnaire study of 288 people with chronic hives found no link between patient, disease, or treatment factors and medical problems at birth, but its abstract does not report levocetirizine-only or trimester-specific results. UK product information says levocetirizine may be considered during pregnancy if needed, while noting limited data for this medicine itself. The direct evidence for late pregnancy remains limited. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- DailyMed: Levocetirizine dihydrochloride tabletsDrug company label
- Kocatürk et al., PREG-CU studyUS government
- UK Summary of Product Characteristics: Levocetirizine
Levocetirizine — Breastfeeding
Research strength: 2 / 5
LactMed says levocetirizine appears acceptable during breastfeeding based on limited information. A 2024 milk study included one levocetirizine user and estimated a relative infant dose of 1.9%; infant outcome data remain limited. LactMed says larger doses or longer use may cause infant drowsiness or other effects, or lower milk supply, especially before supply is established or with pseudoephedrine. NHS SPS prefers cetirizine or loratadine for full-term, healthy infants and advises monitoring with antihistamines, but does not address levocetirizine specifically. DailyMed still says there are no milk data, although the 2024 study measured levocetirizine in human milk. Ask your provider about your situation.
Last reviewed: 2026-10-16
Sources
- LactMed: LevocetirizineUS government
- Nordeng et al., human lactation studyUS government
- NHS Specialist Pharmacy Service: Using antihistamines during breastfeedingUK government
- DailyMed: Levocetirizine dihydrochloride tabletsDrug company label
Pregnancy
FDA labeling says published and postmarketing human data are too limited to identify levocetirizine-related risks of miscarriage, birth defects, or other maternal or fetal outcomes. The 2023 PREG-CU international questionnaire study included 288 patients with chronic urticaria who became pregnant; no link between patient, disease, or treatment factors and medical problems at birth, but the abstract gives no levocetirizine-specific outcome estimate. A 2008 prospective cohort studied cetirizine, not levocetirizine, in 196 first-trimester exposed pregnancies and 1,686 controls. Major birth defects were not more common in the exposed group (OR 1.07; 95% CI 0.21-3.59); estimates for miscarriage and preterm delivery were also not increased. These related-drug data do not establish levocetirizine outcomes. The UK product information reports fewer than 300 pregnancy outcomes with levocetirizine and says its use may be considered if needed, drawing on the larger experience with cetirizine. Direct levocetirizine evidence remains limited.
Breastfeeding
LactMed's 15 September 2025 revision says limited information supports levocetirizine use during breastfeeding, while larger doses or longer use may cause infant drowsiness or other effects or reduce milk supply, especially before lactation is established or with pseudoephedrine. The 2024 ConcePTION human milk study included 32 women: 31 taking cetirizine and one taking levocetirizine. For the one levocetirizine user, the estimated infant dose was 1.1 mcg/kg per day and the relative infant dose was 1.9%; the study reported no severe adverse events. This is a small milk-transfer sample, not a large infant follow-up study. LactMed says relevant published infant-effect information was not found and records one mother's report of no adverse effects in her infant. A 2025 pharmacokinetic model used 205 milk samples from 35 women taking cetirizine or levocetirizine, but modeled cetirizine concentrations, so it does not provide a separate levocetirizine estimate. NHS SPS guidance, updated 5 February 2026, prefers cetirizine or loratadine for full-term, healthy infants and gives general antihistamine monitoring advice, but does not address levocetirizine specifically. DailyMed's current label still states that no levocetirizine milk data are available, although the 2024 study measured human milk levels.
Levocetirizine is the active R-form of cetirizine and an H1 antihistamine. DailyMed identifies levocetirizine dihydrochloride as the active ingredient in its 5 mg tablets.
What was tested
Pregnancy evidence includes animal studies described in product labeling, observational cohorts of cetirizine exposure, and an international questionnaire study of patients with chronic urticaria. The cohort studies were not trials assigning a medicine, and the 2023 questionnaire abstract reports treatment outcomes overall rather than levocetirizine-specific outcomes. Breastfeeding evidence includes serial human milk sampling from 31 cetirizine users and one levocetirizine user in 2024. The 2025 model analyzed cetirizine milk concentrations from combined lactation data; it did not provide levocetirizine-specific infant outcomes.
How the limited pregnancy evidence informs use of levocetirizine
- Source A says
- FDA labeling says available human levocetirizine data are insufficient to identify risks of miscarriage, birth defects, or other maternal or fetal outcomes. (DailyMed: Levocetirizine dihydrochloride tablets (Glenmark))
- Source B says
- UK product information says levocetirizine may be considered during pregnancy if needed, while noting fewer than 300 levocetirizine pregnancy outcomes and referring to more extensive cetirizine data. (UK Summary of Product Characteristics: Levocetirizine 5 mg tablets)
- Why they differ
- Both sources acknowledge limited levocetirizine-specific data. The UK product information draws on the larger experience with cetirizine, while FDA labeling emphasizes that available levocetirizine data do not identify a drug-associated risk.
- What the evidence shows overall
- Direct levocetirizine evidence remains too limited for trimester-specific conclusions. The 2023 international questionnaire study reports antihistamine outcomes overall, not a levocetirizine-only result. The evidence supports an insufficient rating and does not establish a medication-related pregnancy harm.
Whether human milk transfer data exist for levocetirizine
- Source A says
- The current DailyMed label says there are no data on levocetirizine in human milk. (DailyMed: Levocetirizine dihydrochloride tablets (Glenmark))
- Source B says
- A 2024 human lactation study measured milk levels in one levocetirizine user and estimated a relative infant dose of 1.9%; LactMed summarizes this study. (Nordeng et al., human lactation study from the ConcePTION project, LactMed: Levocetirizine)
- Why they differ
- The DailyMed label retains wording that no milk data are available, although a human milk study was published in 2024. The study included only one levocetirizine user and did not provide a large infant safety or milk-production study.
- What the evidence shows overall
- Human milk transfer has been measured, but the direct sample is very small. The label statement is outdated for the presence-in-milk question; infant effects and milk production remain uncertain.
- The NHS says loratadine is usually recommended when an antihistamine is needed during pregnancy. Its general antihistamine page does not give levocetirizine-specific advice. (NHS: Antihistamines)
- NHS SPS identifies cetirizine or loratadine as preferred non-sedating antihistamines for full-term, healthy infants and advises monitoring with antihistamines. Its page does not discuss levocetirizine specifically. (NHS Specialist Pharmacy Service)
General research, not specific to pregnancy.
The FDA issued a Drug Safety Communication on 16 May 2025 about rare but sometimes serious itching after stopping long-term cetirizine or levocetirizine. A 2026 scoping review collected case reports, case series, and retrospective data on this effect, but it could not estimate how often it occurs. The current DailyMed tablet label includes the FDA warning.
- FDA reported 209 cases of itching after stopping cetirizine or levocetirizine from 25 April 2017 through 6 July 2023, including 27 reports involving levocetirizine. The report count does not establish the chance for an individual. (FDA Drug Safety Communication: Itching after stopping cetirizine or levocetirizine)
- FDA says itching typically began within a few days after daily use for a few months to years. Some reported cases followed less than one month of use, and some cases were severe. (FDA Drug Safety Communication: Itching after stopping cetirizine or levocetirizine)
- The current label says new itching may improve with restarting or tapering levocetirizine and advises seeking medical advice if it occurs. (DailyMed: Levocetirizine dihydrochloride tablets (Glenmark))
- A 2026 scoping review included four reports and found 39 levocetirizine-related cases in the selected literature. The review did not assess risk of bias, so this count does not estimate the chance of the reaction. (Rahman et al., scoping review of pruritus after antihistamine discontinuation)
- DailyMed: Levocetirizine dihydrochloride tablets (Glenmark)Drug company labelTertiary
- LactMed: LevocetirizineUS governmentSecondaryPage dated 2025-09-15Independent check
- UK Summary of Product Characteristics: Levocetirizine 5 mg tabletsTertiaryPage dated 2023-06-23
- Kocatürk et al., PREG-CU international study of pregnancy outcomesUS governmentPrimaryIndependent check
- Weber-Schoendorfer and Schaefer, cetirizine pregnancy cohortUS governmentPrimaryIndependent check
- Nordeng et al., human lactation study from the ConcePTION projectUS governmentPrimaryIndependent check
- Melander et al., cetirizine breast milk pharmacokinetic modelUS governmentPrimary
- NHS Specialist Pharmacy Service: Using antihistamines during breastfeedingUK governmentSecondaryPage dated 2026-02-05Independent check
- NHS: AntihistaminesUK governmentSecondaryIndependent check
- FDA Drug Safety Communication: Itching after stopping cetirizine or levocetirizineUS governmentSecondaryPage dated 2026-04-03Independent check
- Rahman et al., scoping review of pruritus after antihistamine discontinuationUS governmentPrimaryIndependent check
Last reviewed 2026-10-16
Independent check 2026-10-16
Not yet clinician-reviewed
Ask your provider about your situation.
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