Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Formoterol fumarate
Drug ID BADD_D00959
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 Formoterol is indicated in various formulations for the treatment of asthma and COPD. For the treatment of COPD, formoterol is available as a single-entity inhalation solution,[L10986] in combination with the long-acting muscarinic antagonists (LAMAs) [aclidinium][L10992] and [glycopyrronium],[L10989] and in combination with the corticosteroid [budesonide].[L10619] For the treatment of asthma, formoterol is available in combination with [mometasone furoate] for patients 5 years and older[L10995] and with budesonide for patients 6 years and older.[L10619] Formoterol may also be used on an as-needed basis for prophylaxis against exercise-induced bronchospasm.[L10998]
Marketing Status approved; investigational
ATC Code R03CC15; R03AC13
DrugBank ID DB00983
KEGG ID D01373
MeSH ID D000068759
PubChem ID 49800025
TTD Drug ID D04KJO
NDC Product Code 46439-8763; 63629-8814; 52221-116; 63629-8813; 53104-7530; 12780-4880; 14501-0087; 63190-0040; 62332-655; 38779-2295; 0093-4061; 70748-261
UNII W34SHF8J2K
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 C23H30N2O9
CAS Registry Number 43229-80-7
SMILES CC(CC1=CC=C(C=C1)OC)NCC(C2=CC(=C(C=C2)O)NC=O)O.C(=CC(=O)O)C(=O)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)
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.002--
Arrhythmia02.03.02.001--Not Available
Asthma22.03.01.002; 10.01.03.010--Not Available
Back pain15.03.04.005--
Bronchitis22.07.01.001; 11.01.09.001--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dry mouth07.06.01.002--
Dysphonia22.12.03.006; 19.19.03.002; 17.02.08.004--
Dyspnoea22.02.01.004; 02.11.05.003--
Fatigue08.01.01.002--
Headache17.14.01.001--
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypertension24.08.02.001--
Hypokalaemia14.05.03.002--
Hypotension24.06.03.002--
Insomnia19.02.01.002; 17.15.03.002--
Lower respiratory tract infection22.07.01.002; 11.01.09.002--Not Available
Malaise08.01.01.003--
Metabolic acidosis14.01.01.003--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Palpitations02.11.04.012--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
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