Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Fexofenadine
Drug ID BADD_D00893
Description Fexofenadine is an over-the-counter second-generation antihistamine used in the treatment of various allergic symptoms.[L4269] It is selective for the H1 receptor, carries little-to-no activity at off-targets, and does not cross the blood-brain barrier[L10779] - this is in contrast to previous first-generation antihistamines, such as [diphenhydramine], which readily bind to off-targets that contribute to side effects such as sedation.[A1452] Fexofenadine is the major active metabolite of [terfenadine][A1495] and is administered as a racemic mixture in which both enantiomers display approximately equivalent antihistamine activity.[L10779]
Indications and Usage In the United States, fexofenadine is indicated for the symptomatic treatment of allergic rhinitis in patients ≥2 years old and chronic idiopathic urticaria in patients ≥6 months old.[L4269] In Canada, fexofenadine carries the same indications but is approved only for patients ≥12 years old.[L10779] Fexofenadine is also available in combination with [pseudoephedrine] for the symptomatic treatment of season allergic rhinitis in patients ≥12 years old.[L10800]
Marketing Status approved; investigational
ATC Code R06AX26
DrugBank ID DB00950
KEGG ID D07958
MeSH ID C093230
PubChem ID 3348
TTD Drug ID D01KPV
NDC Product Code Not Available
UNII E6582LOH6V
Synonyms fexofenadine | alpha-(4-(1-carboxy-1-methylethyl)phenyl)-4-hydroxydiphenylmethyl-1-piperidinebutanol | fexofenadine hydrochloride | MDL 16.455 | MDL-16455 | MDL 16455 | Allegra | Telfast | MDL 16,455A
Chemical Information
Molecular Formula C32H39NO4
CAS Registry Number 83799-24-0
SMILES CC(C)(C1=CC=C(C=C1)C(CCCN2CCC(CC2)C(C3=CC=CC=C3)(C4=CC=CC=C4)O)O)C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dysmenorrhoea21.01.01.002--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.0040.001462%
Ear pain04.03.01.003--
Epistaxis22.04.03.001; 24.07.01.005--
Erythema23.03.06.0010.000166%-
Eye irritation06.04.05.003---
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003---
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Fatigue08.01.01.002--
Feeling cold08.01.09.008---
Feeling hot08.01.09.009---
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.000365%
Gastrointestinal pain07.01.05.005--
Hallucination19.10.04.0030.000166%
Headache17.14.01.0010.000332%
Hyperhidrosis08.01.03.028; 23.02.03.0040.000166%
Hypersensitivity10.01.03.0030.001976%
Increased appetite08.01.09.027; 14.03.01.003---
Infection11.01.08.002---
Influenza like illness08.01.03.010--
Injury12.01.08.004---
Insomnia17.15.03.002; 19.02.01.0020.000930%
Interstitial lung disease10.02.01.033; 22.01.02.0030.000249%-
Irritability08.01.03.011; 19.04.02.013--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.0300.000249%-
Lacrimation disorder06.08.02.010---
Lacrimation increased06.08.02.0040.001129%
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.0070.000332%-
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