Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Formoterol
Drug ID BADD_D00958
Description Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001.[L10986] It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers.[A189528] A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as [salbutamol], combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication.[L11256] It is available as a single-entity product[L10986,L11223] and in several formulations in combination with both inhaled corticosteroids[L10995,L10619] and long-acting muscarinic antagonists.[L10992,L10989]
Indications and Usage For use as long-term maintenance treatment of asthma in patients 6 years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma, who are using optimal corticosteroid treatment and experiencing regular or frequent breakthrough symptoms requiring use of a short-acting bronchodilator. Not indicated for asthma that can be successfully managed with occasional use of an inhaled, short-acting beta2-adrenergic agonist. Also used for the prevention of exercise-induced bronchospasm, as well as long-term treatment of bronchospasm associated with COPD.
Marketing Status Prescription; Discontinued
ATC Code R03AC13; R03CC15
DrugBank ID DB00983
KEGG ID D07990
MeSH ID D000068759
PubChem ID 3410
TTD Drug ID D04KJO
NDC Product Code Not Available
Synonyms Formoterol Fumarate | Formoterol Fumarate, ((R*,R*)-(+-))-isomer | 3-Formylamino-4-hydroxy-alpha-(N-1-methyl-2-p-methoxyphenethylaminomethyl)benzyl alcohol.hemifumarate | BD 40A | Formoterol | Eformoterol | Oxis | Arformoterol | Formoterol, ((R*,R*)-(+-))-isomer | Foradil
Chemical Information
Molecular Formula C19H24N2O4
CAS Registry Number 43229-80-7
SMILES CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Eosinophilic disordersC-X-C motif chemokine 10P02778T3063526344080
Eosinophilic disordersInterleukin-5P05113T7858526344080
Surgical and medical proceduresBeta-2 adrenergic receptorP07550T5252211804270; 11586955; 10988267; 10984540; 11306963; 10340917; 9399966
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain07.01.05.002--
Acute sinusitis22.07.03.013; 11.01.13.012--Not Available
Agitation19.06.02.001; 17.02.05.012--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Asthenia08.01.01.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Blood pressure increased13.14.03.005--Not Available
Body temperature increased13.15.01.001--Not Available
Bronchitis22.07.01.001; 11.01.09.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Bronchospasm paradoxical22.03.01.006--Not Available
Chest pain22.02.08.003; 08.01.08.002; 02.02.02.011--Not Available
Conjunctival irritation06.04.01.007--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Cough22.02.03.001--
Dermatitis23.03.04.002--Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.003--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.007--
Dry mouth07.06.01.002--
Dysgeusia17.02.07.003; 07.14.03.001--
Dyspepsia07.01.02.001--
Dysphonia22.02.05.005; 19.19.03.002; 17.02.08.004--
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