Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tiotropium
Drug ID BADD_D02443
Description Tiotropium is a long-acting, antimuscarinic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD) and asthma.[A180163,L7084,L7087,L7090,L7093] Tiotropium acts mainly on M3 muscarinic receptors located in the airways to produce smooth muscle relaxation and bronchodilation.[A180163,L7084,L7087,L7090,L7093] Tiotropium is more specific for the subset of muscarinic receptors commonly found in the lungs than [ipratropium].[A180163] Tiotropium was granted FDA approval on 30 January 2004.[L7084]
Indications and Usage Tiotropium powder for inhalation is indicated for the maintenance of bronchospasm in COPD and to prevent exacerbations of COPD.[L7084] A combination tiotropium and [olodaterol] metered inhalation spray is indicated for maintenance of COPD.[L7087] A tiotropium inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 12 or more years old.[L7090] A tiotropium metered inhalation spray is indicated for the maintenance of bronchospasm in COPD, to prevent exacerbations of COPD, and to treat asthma in patients 6 or more years old.[L7093]
Marketing Status approved
ATC Code R03BB04
DrugBank ID DB01409
KEGG ID D01929
MeSH ID D000069447
PubChem ID 5487427
TTD Drug ID D0P1WA
NDC Product Code Not Available
UNII 0EB439235F
Synonyms Tiotropium Bromide | Bromide, Tiotropium | 7-((hydroxybis(2-thienyl)acetyl)oxy)-9,9-dimethyl-3-oxa-9-azoniatricyclo(3.3.1.0(2,4))nonane bromide | Tiotropium | Spiriva | BA 679 BR | 679 BR, BA | BR, BA 679 | BA-679 BR | BA679 BR
Chemical Information
Molecular Formula C19H22NO4S2+
CAS Registry Number 186691-13-4
SMILES C[N+]1(C2CC(CC1C3C2O3)OC(=O)C(C4=CC=CS4)(C5=CC=CS5)O)C
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)
Supraventricular extrasystoles02.03.03.0110.000057%Not Available
Supraventricular tachycardia02.03.03.0120.000057%
Swollen tongue07.14.02.003; 23.04.01.014; 10.01.05.0150.000506%Not Available
Systemic lupus erythematosus23.03.02.006; 10.04.03.004; 15.06.02.0030.000057%Not Available
Tension19.06.02.0050.000155%Not Available
Therapeutic response decreased08.06.01.016--Not Available
Therapeutic response unexpected08.06.01.001--Not Available
Throat irritation22.12.03.029; 07.05.05.0370.001816%Not Available
Throat tightness22.12.03.031; 19.01.02.0050.000379%Not Available
Thrombocytosis01.08.02.0010.000057%Not Available
Tongue discolouration07.14.02.0060.000391%Not Available
Tooth discolouration07.09.02.0010.000293%
Transient ischaemic attack24.04.06.005; 17.08.04.0010.000172%
Tremor17.01.06.0020.001724%
Urinary incontinence20.02.02.010; 17.05.01.0080.000086%
Urinary retention20.02.02.0110.001862%
Urinary tract disorder20.08.01.0010.000126%Not Available
Ventricular extrasystoles02.03.04.0070.000282%Not Available
Vision blurred17.17.01.010; 06.02.06.0070.001672%
Visual acuity reduced06.02.10.012; 17.17.01.0110.000322%
Wheezing22.03.01.0090.002115%
Fibromyalgia15.05.02.0020.000184%Not Available
Hypoacusis04.02.01.0060.001035%
Brain oedema17.07.02.003; 12.01.10.0100.000086%
Carotid artery occlusion24.04.06.008; 17.08.01.0120.000144%Not Available
General physical health deterioration08.01.03.0180.000724%Not Available
Tachyarrhythmia02.03.02.0080.000057%Not Available
Upper respiratory tract inflammation22.12.03.0340.000126%Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.0030.000086%Not Available
Intervertebral disc protrusion15.10.01.0040.000086%Not Available
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