Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Levocetirizine
Drug ID BADD_D01272
Description Levocetirizine is a selective histamine H1 antagonist used to treat a variety of allergic symptoms.[A181748,A181790,L7694] It is the R enantiomer of [cetirizine].[L7694] Levocetirizine has greater affinity for the histamine H1 receptor than cetirizine.[L7694] Levocetirizine was granted FDA approval in 1995.[L7694]
Indications and Usage Levocetirizine is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
Marketing Status Prescription; OTC; Discontinued
ATC Code R06AE09
DrugBank ID DB06282
KEGG ID D07402
MeSH ID C472067
PubChem ID 1549000
TTD Drug ID D0M8PW
NDC Product Code Not Available
Synonyms levocetirizine | levocetrizine | acetic acid, (2-(4-((R)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)- | (2-(4-((R)-p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)acetic acid | levocetirizine hydrochloride | Xusal | levocetirizine dihydrochloride | (2-(4-((R)-(4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)acetic acid dihydrochloride | cetirizine (R)-form dihydrochloride | acetic acid, (2-(4-((R)-(4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, dihydrochloride | Xyzal | UCB-28556
Chemical Information
Molecular Formula C21H25ClN2O3
CAS Registry Number 130018-77-8
SMILES C1CN(CCN1CCOCC(=O)O)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.0030.001169%
Acne23.02.01.0010.000877%Not Available
Activated partial thromboplastin time prolonged13.01.02.0010.000877%
Aggression19.05.01.0010.000585%Not Available
Agitation17.02.05.012; 19.06.02.001--
Agranulocytosis01.02.03.0010.000585%Not Available
Alanine aminotransferase increased13.03.01.0030.001462%
Alopecia23.02.02.001--
Altered state of consciousness17.02.04.001; 19.07.01.0030.001462%Not Available
Anal fissure07.03.01.0020.000585%
Anal fistula07.11.05.0020.000585%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.001169%
Anaphylactic shock10.01.07.002; 24.06.02.0040.001169%Not Available
Angina pectoris02.02.02.002; 24.04.04.0020.000877%
Angioedema10.01.05.009; 23.04.01.0010.001754%Not Available
Angle closure glaucoma06.03.01.0010.000585%Not Available
Arrhythmia02.03.02.0010.002631%Not Available
Ascites02.05.04.002; 07.07.01.001; 09.01.05.0030.000877%
Aspartate aminotransferase increased13.03.01.0060.001462%
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.0020.000877%
Autoimmune hepatitis09.01.07.019; 10.04.09.0010.000585%Not Available
Back pain15.03.04.005--
Bilirubin conjugated increased13.03.01.0070.000585%Not Available
Blindness06.02.02.001; 17.17.01.0030.000585%Not Available
Blood albumin decreased13.09.01.0010.000585%Not Available
Blood bilirubin increased13.03.01.0080.000585%
Blood fibrinogen decreased13.01.02.0030.000585%
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