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
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(,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
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)
Abdominal distension07.01.04.0010.000356%
Abdominal tenderness07.01.05.0040.000057%Not Available
Abnormal faeces07.01.03.0010.000057%Not Available
Acute pulmonary oedema22.01.03.005; Available
Acute respiratory failure14.01.04.004; Available
Amaurosis fugax06.02.10.002;; Available
Anaphylactic shock24.06.02.004; Available
Angina pectoris24.04.04.002;
Angina unstable24.04.04.004; Available
Angioedema22.04.02.008;; Available
Anuria20.01.03.0020.000057%Not Available
Aortic aneurysm24.02.03.0010.000144%Not Available
Aortic stenosis24.04.01.0010.000115%Not Available
Arrhythmia02.03.02.0010.000328%Not Available
Asphyxia12.01.08.011; Available
Asthma22.03.01.002; Available
Atrial fibrillation02.03.03.0020.000603%
Atrial flutter02.03.03.0030.000086%
Atrioventricular block02.03.01.0020.000057%Not Available
Atrioventricular block complete02.03.01.0030.000057%
Benign prostatic hyperplasia21.04.02.0010.000690%Not Available
Blindness06.02.10.003; Available
Bronchiectasis22.03.02.0050.000368%Not Available
Bronchospasm paradoxical22.03.01.0060.000086%Not Available
Burning sensation17.02.06.001; Available
Cardiac failure02.05.01.0010.000661%
Cardiac failure congestive02.05.01.0020.000546%Not Available
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