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)
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.000086%
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.000057%Not Available
Respiratory tract congestion22.02.07.0030.000195%Not Available
Inappropriate antidiuretic hormone secretion05.03.03.001; 14.05.07.0010.000172%Not Available
Secretion discharge08.01.03.0190.000351%Not Available
Cardiac discomfort02.11.04.001--Not Available
Pulmonary mass22.02.07.0040.000086%Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.000224%Not Available
Paraesthesia oral17.02.06.008; 07.05.05.0350.000126%Not Available
Toxic skin eruption12.03.01.073; 23.03.05.003; 10.01.01.0080.000057%Not Available
Lung neoplasm malignant22.08.01.001; 16.19.02.0010.001207%Not Available
Restless legs syndrome17.02.07.008; 15.05.03.0120.000253%Not Available
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000086%Not Available
Bladder disorder20.03.01.0020.000253%Not Available
Cardiac disorder02.11.01.0030.000345%Not Available
Motor dysfunction15.05.06.006; 17.01.02.0310.000195%Not Available
Parkinson's disease17.01.05.010--Not Available
Sensation of foreign body08.01.09.0020.000351%Not Available
Urinary tract obstruction20.08.01.0040.000126%
Vocal cord disorder22.04.01.0030.000126%Not Available
Cardiac fibrillation02.03.02.0210.000057%Not Available
Obstructive airways disorder22.03.01.0110.000529%Not Available
Lung neoplasm22.08.01.006; 16.19.04.0010.000057%Not Available
Unevaluable event08.01.03.0510.001523%Not Available
Arterial occlusive disease24.04.02.021--Not Available
Increased upper airway secretion22.12.03.0070.000546%Not Available
Pharyngeal disorder22.04.05.0070.000155%Not Available
Low birth weight baby18.04.02.0030.000144%Not Available
Oral disorder07.05.01.0050.000126%Not Available
Oropharyngeal discomfort22.12.03.015; 07.05.05.0080.000213%Not Available
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