Cetirizine (ophthalmic)

FDA label, Harrow Eye, LLC, ophthalmic, effective 2026-08-03. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Histamine-1 Receptor Antagonist

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Contraindications

None. None. ( 4 )

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

C

Likelihood score C: Probable rare cause of clinically apparent liver injury.

Cetirizine and its enantiomer levocetirizine are second generation antihistamines that are used for the treatment of allergic rhinitis, angioedema and chronic urticaria. Cetirizine and levocetirizine have been linked to rare, isolated instances of clinically apparent acute liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Cetirizine (NIDDK, public domain)Chapter updated Jan 16, 2017

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Risk Summary There were no adequate or well-controlled studies with ZERVIATE ® in pregnant women. Cetirizine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data Cetirizine was not teratogenic in mice, rats, or rabbits at oral doses up to 96, 225, and 135 mg/kg, respectively (approximately 1300, 4930, and 7400 times the maximum recommended human ophthalmic dose (MRHOD), on a mg/m 2 basis).

Breastfeeding (LactMed)

Small occasional doses of cetirizine are acceptable during breastfeeding. Larger doses or more prolonged use may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. International guidelines recommend cetirizine as an acceptable choice if an antihistamine is required during breastfeeding. Cetirizine has been used successfully in cases of persistent pain of the breast during breastfeeding. Ophthalmic use of cetirizine by the mother should pose little risk to the breastfed infant. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Alternatives LactMed suggests considering:
Source: LactMed: Cetirizine (NICHD, public domain)Revised Sep 15, 2025

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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