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    HomeMedication GuideCetirizine Safety
    Second-generation antihistamine

    Cetirizine: What to Know Before You Take It

    Also sold as Zyrtec

    What Cetirizine Is Used For

    Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

    Warnings

    Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

    Most-Reported Side Effects

    Based on 169,947 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.

    drug ineffective21,873fatigue19,067pain16,074off label use14,268rash13,436headache12,842pruritus12,588nausea12,087dyspnoea11,321abdominal discomfort10,639alopecia10,530arthralgia10,413

    Explore full Cetirizine safety data in our free FDA Safety Explorer

    FDA Recalls (10)

    Class IIIOngoingSep 12, 2025

    Tablet/Capsules Imprinted with Wrong ID

    Recalling firm: JB Chemicals and Pharmaceuticals Ltd

    Class IIIOngoingSep 12, 2025

    Tablet/Capsules Imprinted with Wrong ID

    Recalling firm: JB Chemicals and Pharmaceuticals Ltd

    Class IIOngoingMar 13, 2025

    CGMP Deviations

    Recalling firm: Glenmark Pharmaceuticals Inc., USA

    Class IIITerminatedOct 5, 2021

    Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

    Recalling firm: A-S Medication Solutions LLC.

    Class IITerminatedOct 19, 2018

    Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

    Recalling firm: Taro Pharmaceuticals U.S.A., Inc.

    Class IIITerminatedApr 18, 2017

    Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

    Recalling firm: Sun Pharmaceutical Industries, Inc.

    Class IIITerminatedSep 28, 2015

    Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester

    Recalling firm: Perrigo Company PLC

    Class IIITerminatedApr 9, 2014

    Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

    Recalling firm: Caraco Pharmaceutical Laboratories, Ltd.

    Class IIITerminatedApr 9, 2014

    Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide

    Recalling firm: Caraco Pharmaceutical Laboratories, Ltd.

    Class IIITerminatedSep 20, 2012

    Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)

    Recalling firm: Sandoz Incorporated

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

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