> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/cetirizine-hydrochloride-0f5b8ec9-315b-492f-b7a3-de74652b5fd2 > Record changed: 2026-10-13 # Cetirizine hydrochloride Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) First approval year 1995 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) ## Development status **First approval year** 1995 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **Drug name** Cetirizine hydrochloride Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **Molecular weight** 461.82 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **Structure (SMILES)** Cl.Cl.O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) ### Brand names (48) - allacan - Allacan - allertek - Allertek - becoallergy - Becoallergy - cetec - Cetec - cetirizine hydrochloride - Cetirizine hydrochloride - cetirizine hydrochloride allergy - Cetirizine hydrochloride allergy - cetirizine hydrochloride component of zyrtec d - Cetirizine hydrochloride component of zyrtec-d - cetirizine hydrochloride hives - Cetirizine hydrochloride hives - cetirizine hydrochloride hives relief - Cetirizine hydrochloride hives relief - cetirocol - Cetirocol - children s cetirizine hydrochloride allergy - children s cetirizine hydrochloride hives relief - children s zyrtec allergy - children s zyrtec hives relief - Children's cetirizine hydrochloride allergy And 23 more, listed on the interactive page. ### Other names (44) - acetic acid 2 4 4 chlorophenyl phenylmethyl 1 piperazinyl ethoxy dihydrochloride - Acetic acid, \[2-\[4-\[(4-chlorophenyl)phenylmethyl\]-1-piperazinyl\]ethoxy\]-, dihydrochloride, (±)- - cetirizine dihydrochloride - Cetirizine dihydrochloride - cetirizine dihydrochloride (rescue medication) - Cetirizine dihydrochloride \[EP MONOGRAPH\] - Cetirizine dihydrochloride \[MI\] - cetirizine dihydrochloride ep monograph - cetirizine dihydrochloride mi - cetirizine dihydrochloride rescue medication - cetirizine hcl - Cetirizine hcl - cetirizine hydrochloride - Cetirizine hydrochloride - Cetirizine hydrochloride \[JAN\] - Cetirizine hydrochloride \[MART.\] - Cetirizine hydrochloride \[ORANGE BOOK\] - Cetirizine hydrochloride \[USAN\] - Cetirizine hydrochloride \[USP MONOGRAPH\] - Cetirizine hydrochloride \[USP-RS\] - Cetirizine hydrochloride \[VANDF\] - Cetirizine hydrochloride \[WHO-DD\] - cetirizine hydrochloride jan - cetirizine hydrochloride mart - cetirizine hydrochloride orange book And 19 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 83881-52-1 **ChEMBL ID** CHEMBL1607273 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **InChIKey** PGLIUCLTXOYQMV-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1607273) **RxNorm IDs (RxCUI)** - 203150 **FDA ingredient codes (UNII)** - 64O047KTOA ### PubChem compound IDs (3) - 55182 - 44659863 - 57515953 ## Regulatory information ### United States **Applicant** KENVUE BRANDS **Approval date** 8 Dec 1995 **Application number** NDA019835 ### Other regulatory facts **Patents** 11 **Designations** 0 **Earliest recorded loss of exclusivity** 9 Jan 2033 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Over the counter ## Pharmacology ### Drug classification #### Administration routes - Oral - Parenteral - topical ### Mechanisms of action - **Mechanism** Histamine H1 receptor antagonist **Action type** Antagonist **Target** Histamine H1 receptor **Protein identifier** P35367 ### Open Targets mechanisms - **Mechanism** Histamine H1 receptor antagonist **Action type** Antagonist **Target** Histamine H1 receptor ### Investigated indications (9) - **Condition** Prostatitis **Highest recorded phase** 0.5 **Condition identifier** EFO:0003830 **Subject identifier** D011472 - **Condition** Rhinitis, Allergic, Seasonal **Highest recorded phase** 4 **Condition identifier** EFO:0003956 **Subject identifier** D006255 - **Condition** Urticaria **Highest recorded phase** 4 **Condition identifier** EFO:0005531 **Subject identifier** D014581 - **Condition** Rhinitis, Allergic, Seasonal **Highest recorded phase** 4 **Condition identifier** EFO:0005854 **Subject identifier** D006255 - **Condition** Conjunctivitis, Allergic **Highest recorded phase** 4 **Condition identifier** EFO:0007141 **Subject identifier** D003233 - **Condition** Rhinitis, Allergic, Perennial **Highest recorded phase** 4 **Condition identifier** EFO:1001417 **Subject identifier** D012221 - **Condition** Pruritus **Highest recorded phase** 4 **Condition identifier** HP:0000989 **Subject identifier** D011537 - **Condition** Nasal Obstruction **Highest recorded phase** 4 **Condition identifier** HP:0001742 **Subject identifier** D015508 - **Condition** Hypersensitivity **Highest recorded phase** 1 **Condition identifier** MONDO:0005271 **Subject identifier** D006967 ### Open Targets indications (17) - **Condition identifier** EFO\_0003830 - **Condition identifier** EFO\_0003956 - **Condition identifier** EFO\_0005531 - **Condition identifier** EFO\_0005854 - **Condition identifier** EFO\_0007141 - **Condition identifier** EFO\_1001417 - **Condition identifier** HP\_0000989 - **Condition identifier** HP\_0000989 **Highest recorded phase** 4 - **Condition identifier** HP\_0001742 - **Condition identifier** HP\_0001742 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005271 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005324 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005492 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005642 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0011786 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0022103 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0024332 **Highest recorded phase** 4 ### Reported adverse events (84) - **Event** abdominal discomfort **Reports** 2,158 **Reporting signal score** 6,206.32 - **Event** alopecia **Reports** 2,131 **Reporting signal score** 6,067.63 - **Event** angioedema **Reports** 208 **Reporting signal score** 196.208 - **Event** anti-cyclic citrullinated peptide antibody positive **Reports** 938 **Reporting signal score** 4,708.58 - **Event** arthralgia **Reports** 690 **Reporting signal score** 497.334 - **Event** arthropathy **Reports** 1,382 **Reporting signal score** 4,276.19 - **Event** asthma **Reports** 213 **Reporting signal score** 198.03 - **Event** blister **Reports** 484 **Reporting signal score** 1,039.27 - **Event** blood cholesterol increased **Reports** 225 **Reporting signal score** 381.063 - **Event** bursitis **Reports** 97 **Reporting signal score** 199.541 - **Event** chronic spontaneous urticaria **Reports** 34 **Reporting signal score** 117.471 - **Event** coeliac disease **Reports** 88 **Reporting signal score** 217.422 - **Event** condition aggravated **Reports** 879 **Reporting signal score** 975.665 - **Event** confusional state **Reports** 399 **Reporting signal score** 345.294 - **Event** contusion **Reports** 274 **Reporting signal score** 325.112 - **Event** discomfort **Reports** 1,212 **Reporting signal score** 4,044.13 - **Event** drug hypersensitivity **Reports** 399 **Reporting signal score** 173.572 - **Event** drug intolerance **Reports** 1,257 **Reporting signal score** 2,809.77 - **Event** drug tolerance decreased **Reports** 45 **Reporting signal score** 125.51 - **Event** dry mouth **Reports** 128 **Reporting signal score** 101.056 - **Event** duodenal ulcer perforation **Reports** 605 **Reporting signal score** 2,879.39 - **Event** dyspnoea **Reports** 559 **Reporting signal score** 151.814 - **Event** electric shock **Reports** 34 **Reporting signal score** 124.415 - **Event** erythema **Reports** 233 **Reporting signal score** 106.817 - **Event** fatigue **Reports** 2,052 **Reporting signal score** 2,409.29 And 59 more, listed on the interactive page. ### Trial references (7) - NCT00533637 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00533637) - NCT00881127 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00881127) - NCT00881634 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00881634) - NCT04071821 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04071821) - NCT01651871 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01651871) - NCT02024152 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02024152) - NCT03167216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03167216) ## Dosing **Dose** 10 mg **How often** Once daily ### Conditions of use - Do not take more than one 10 mg tablet in 24 hours ## Chemical properties **Hydrogen bond acceptors** 4 **Hydrogen bond donors** 1 **Polar surface area** 53.01 **Calculated partition coefficient (ALogP)** 3.15 **Prodrug** No **Chirality** Racemic **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 8 **Heavy atoms** 29 **Molecular formula** C21H27Cl3N2O3 **Monoisotopic mass** 460.108726 **Natural product** No ## National Drug Codes - 0121-0874 - 16571-134 - 23155-929 - 45802-626 - 61037-479 - 62135-057 - 65162-684 - 68118-200 - 69206-990 - 69452-426 - 70720-100 - 71205-435 - 72888-480 - 83745-185 - 50090-5220 - 51672-4070 - 68788-8282 - 68788-8523 - 68788-8890 ## Evidence counts **Recorded assays** 957 **Active assays** 8 ### Active assay types (4) - Confirmatory - Other - Screening - Summary ## Pharmacologic actions - Anti-Allergic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018926.html) - Histamine H1 Antagonists, Non-Sedating Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D039563.html) ## Related records ### Trials (124) - 723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover - [A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)](https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-56fce060-49d9-425a-b6b7-c3a1f8ae972e.md) - [A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)](https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-based-treatment-99be48a0-44f7-46eb-bdf5-d3d2adc6018e.md) - A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) - [A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)](https://trialight.com/data/trial/a-clinical-study-of-raludotatug-deruxtecan-in-people-with-6b1e5a4a-56bb-4891-a239-d464dd0753c5.md) - A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) - [A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)](https://trialight.com/data/trial/a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-47421f86-889b-4c0b-a65c-14ed97707a1e.md) - [A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)](https://trialight.com/data/trial/a-clinical-study-of-zilovertamab-vedotin-mk-2140-plus-134b8f98-3329-4e9d-af03-b73bfdbc1295.md) - A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) - A Clinical Trial of MK-4082 in Healthy Participants (MK-4082-005) - A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735) - A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736) - A Comparator Study of Fluticasone Propionate Nasal Spray Verses (vs) Cetirizine in the Treatment of Seasonal Allergic Rhinitis - A Cross Over Study to Compare the Effect of Combined Treatment With QAV680 and Cetirizine - A Dose-Finding Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-006) - A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007) - A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma - A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) - A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber ### Approved for (5) - [Allergic rhinitis](https://trialight.com/data/condition/allergic-rhinitis-5900f04b-c465-5b16-bbb0-e03e4c2cbdfc.md) - Atopic conjunctivitis - Perennial allergic rhinitis - [Seasonal allergic rhinitis](https://trialight.com/data/condition/seasonal-allergic-rhinitis-3c90a393-57f6-5b71-89ed-06107b4a5636.md) - Urticaria ### In development for (2) - Allergic disease Phase 1 - Prostatitis Early phase 1 ### Targets (1) - [HRH1](https://trialight.com/data/target/hrh1-066d4575-4b1c-5ce9-adf8-b080f76b770b.md) Histamine H1 receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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