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    HomeMedication GuideCetirizine safety
    Second-generation antihistamine

    Cetirizine: What to Know Before You Take It

    Also known as Zyrtec

    A patient-focused safety profile with information from public regulatory sources.

    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    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

    Read before you decide

    Risks and precautions

    Risks and 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)

    FDA safety data

    Most-reported side effects

    Based on 169,947 FAERS reports. Reports do not prove the drug caused the effect.

    drug ineffective 21,873fatigue 19,067pain 16,074off label use 14,268rash 13,436headache 12,842pruritus 12,588nausea 12,087dyspnoea 11,321abdominal discomfort 10,639alopecia 10,530arthralgia 10,413
    Explore full FDA safety data

    Regulatory record

    FDA recalls (10)

    Class IIIOngoing · Sep 12, 2025

    Tablet/Capsules Imprinted with Wrong ID

    Recalling firm: JB Chemicals and Pharmaceuticals Ltd

    Class IIIOngoing · Sep 12, 2025

    Tablet/Capsules Imprinted with Wrong ID

    Recalling firm: JB Chemicals and Pharmaceuticals Ltd

    Class IIOngoing · Mar 13, 2025

    CGMP Deviations

    Recalling firm: Glenmark Pharmaceuticals Inc., USA

    Class IIITerminated · Oct 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 IITerminated · Oct 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 IIITerminated · Apr 18, 2017

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

    Recalling firm: Sun Pharmaceutical Industries, Inc.

    Class IIITerminated · Sep 28, 2015

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

    Recalling firm: Perrigo Company PLC

    Class IIITerminated · Apr 9, 2014

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

    Recalling firm: Caraco Pharmaceutical Laboratories, Ltd.

    Class IIITerminated · Apr 9, 2014

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

    Recalling firm: Caraco Pharmaceutical Laboratories, Ltd.

    Class IIITerminated · Sep 20, 2012

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

    Recalling firm: Sandoz Incorporated

    Common questions

    Patient questions

    What is Cetirizine prescribed 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

    What are the key warnings and safety precautions for Cetirizine?

    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)

    Does Cetirizine interact with other medications or foods?

    Cetirizine has 0 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.

    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.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.