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)
Pulmonary oedema02.05.02.003; 22.01.03.003--
Purpura24.07.06.005; 23.06.01.004; 01.01.04.0030.000155%
Rales22.12.01.0110.000115%Not Available
Rash macular23.03.13.0030.000213%Not Available
Respiration abnormal22.02.01.0410.000155%Not Available
Respiratory arrest22.02.01.0090.000144%Not Available
Respiratory disorder22.02.07.0020.000678%Not Available
Respiratory distress22.02.01.0120.000460%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.001236%
Respiratory tract irritation22.02.07.0120.000293%Not Available
Retching07.01.07.0020.000782%Not Available
Rheumatoid arthritis15.01.03.001; 10.04.06.0010.000339%Not Available
Rhinorrhoea22.12.03.0210.000879%
Right ventricular failure02.05.03.0020.000057%Not Available
Serum sickness12.02.08.004; 10.01.03.0040.000126%
Skin irritation23.03.04.0090.000195%Not Available
Skin reaction23.03.03.013; 10.01.03.0190.000126%Not Available
Sleep apnoea syndrome19.02.05.002; 17.15.05.001; 22.02.01.0130.000086%
Sleep disorder19.02.04.001--Not Available
Small cell lung cancer22.08.01.013; 16.19.08.0030.000057%Not Available
Sneezing22.12.03.0240.000351%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.000339%Not Available
Spinal osteoarthritis15.01.04.0030.000057%Not Available
Sputum discoloured22.02.03.0100.000270%Not Available
Sputum increased22.02.03.0070.000184%Not Available
Squamous cell carcinoma of lung22.08.01.014; 16.19.01.0060.000057%Not Available
Stomatitis07.05.06.0050.000580%
Stress19.06.02.004--Not Available
Stridor22.04.02.0030.000086%
Sudden death08.04.01.003; 02.03.04.0130.000086%
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