Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Astemizole
Drug ID BADD_D02613
Description Astemizole is a long-acting, non-sedating second generation antihistamine used in the treatment of allergy symptoms. It was withdrawn from market by the manufacturer in 1999 due to the potential to cause arrhythmias at high doses, especially when when taken with CYP inhibitors or grapefruit juice.
Indications and Usage Astemizole was indicated for use in the relieving allergy symptoms, particularly rhinitis and conjunctivitis. It has been withdrawn from the market however due to concerns of arrhythmias.
Marketing Status approved; withdrawn
ATC Code R06AX11
DrugBank ID DB00637
KEGG ID D00234
MeSH ID D016589
PubChem ID 2247
TTD Drug ID D0Y2HR
NDC Product Code Not Available
UNII 7HU6337315
Synonyms Astemizole | Astemizol Alonga | Alonga, Astemizol | Astemizol Ratiopharm | Ratiopharm, Astemizol | Astesen | Emdar | Esmacen | Fustermizol | Hismanal | Histaminos | Hubermizol | Laridal | Paralergin | R-43-512 | R 43 512 | R43512 | Retolen | Rifedot | Rimbol | Romadin | Simprox | Urdrim | Alermizol | Astemina
Chemical Information
Molecular Formula C28H31FN4O
CAS Registry Number 68844-77-9
SMILES COC1=CC=C(C=C1)CCN2CCC(CC2)NC3=NC4=CC=CC=C4N3CC5=CC=C(C=C5)F
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)
Agitation17.02.05.012; 19.06.02.001--
Asthenia08.01.01.001---
Depression19.15.01.001--
Disturbance in attention17.03.03.001; 19.21.02.002--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Headache17.14.01.001--
Hypertension24.08.02.001--
Insomnia17.15.03.002; 19.02.01.002--
Irritability08.01.03.011; 19.04.02.013--
Jaundice neonatal01.06.04.006; 09.01.01.008; 18.04.08.001---
Lethargy08.01.01.008; 17.02.04.003; 19.04.04.004--
Mental impairment17.03.03.002; 19.21.02.003---
Nausea07.01.07.001--
Nightmare19.02.03.003---
Personality disorder19.05.02.002---
Somnolence17.02.04.006; 19.02.05.003--
Stillbirth08.04.01.006; 18.01.02.002---
Vomiting07.01.07.003--
Affect lability19.04.01.001---
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