Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tiotropium bromide monohydrate
Drug ID BADD_D02225
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 11431811
TTD Drug ID D0P1WA
NDC Product Code 64567-0026; 66412-0761; 61662-0021; 63190-0380; 63190-0560
UNII L64SXO195N
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 C19H24BrNO5S2
CAS Registry Number 139404-48-1
SMILES C[N+]1(C2CC(CC1C3C2O3)OC(=O)C(C4=CC=CS4)(C5=CC=CS5)O)C.O.[Br-]
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)
Insomnia19.02.01.002; 17.15.03.002--
Intestinal obstruction07.13.01.002--Not Available
Intraocular pressure increased13.07.04.002--Not Available
Joint swelling15.01.02.004--Not Available
Laryngeal pain22.12.03.010--
Laryngitis22.07.03.001; 11.01.13.001--
Mouth ulceration07.05.06.004--Not Available
Myalgia15.05.02.001--
Oedema14.05.06.010; 08.01.07.006--Not Available
Oral candidiasis07.05.07.001; 11.03.03.004--Not Available
Pain in extremity15.03.04.010--
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Pharyngitis07.05.07.004; 22.07.03.004; 11.01.13.003--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rhinitis22.07.03.006; 11.01.13.004--
Sinusitis22.07.03.007; 11.01.13.005--
Skin infection23.11.04.007; 11.01.12.003--
Skin ulcer24.04.03.007; 23.07.03.003--
Stomatitis07.05.06.005--
Supraventricular tachycardia02.03.03.012--
Tachycardia02.03.02.007--Not Available
Throat irritation07.05.05.037; 22.12.03.029--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urinary retention20.02.02.011--
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria10.01.06.001; 23.04.02.001--
Vomiting07.01.07.003--
Oropharyngeal candidiasis22.07.03.003; 07.05.07.003; 11.03.03.006--Not Available
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