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TIOTROPIUM

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Tiotropium Adverse Events Reported to the FDA Over Time

How are Tiotropium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Tiotropium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Tiotropium is flagged as the suspect drug causing the adverse event.

Most Common Tiotropium Adverse Events Reported to the FDA

What are the most common Tiotropium adverse events reported to the FDA?

Incorrect Route Of Drug Administrat...
11855 (15.48%)
Dyspnoea
5308 (6.93%)
Drug Ineffective
4273 (5.58%)
Dry Mouth
1876 (2.45%)
Cough
1393 (1.82%)
Pneumonia
1053 (1.37%)
Chronic Obstructive Pulmonary Disea...
900 (1.18%)
Dysphonia
886 (1.16%)
Vision Blurred
816 (1.07%)
Constipation
664 (.87%)
Dizziness
605 (.79%)
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Urinary Retention
581 (.76%)
Headache
554 (.72%)
Death
552 (.72%)
Chest Discomfort
504 (.66%)
Nausea
481 (.63%)
Ageusia
456 (.6%)
Dysuria
442 (.58%)
Chest Pain
439 (.57%)
Rash
436 (.57%)
Dysgeusia
424 (.55%)
Fatigue
417 (.54%)
Bronchitis
406 (.53%)
Asthenia
405 (.53%)
Wheezing
405 (.53%)
Malaise
399 (.52%)
Lung Neoplasm Malignant
357 (.47%)
Eye Pain
352 (.46%)
Oedema Peripheral
350 (.46%)
Myocardial Infarction
336 (.44%)
Oropharyngeal Pain
332 (.43%)
Pruritus
307 (.4%)
Throat Irritation
306 (.4%)
Insomnia
292 (.38%)
Feeling Abnormal
281 (.37%)
Hypersensitivity
279 (.36%)
Hypertension
273 (.36%)
Heart Rate Increased
271 (.35%)
Diarrhoea
270 (.35%)
Fall
269 (.35%)
Urinary Tract Infection
269 (.35%)
Cataract
268 (.35%)
Increased Upper Airway Secretion
266 (.35%)
Swollen Tongue
265 (.35%)
Condition Aggravated
257 (.34%)
Productive Cough
256 (.33%)
Asthma
255 (.33%)
Pain In Extremity
249 (.33%)
Pain
248 (.32%)
Drug Effect Decreased
245 (.32%)
Anxiety
242 (.32%)
Tremor
239 (.31%)
Atrial Fibrillation
237 (.31%)
Nasopharyngitis
234 (.31%)
Dysphagia
233 (.3%)
Cardiac Failure Congestive
232 (.3%)
Dry Throat
229 (.3%)
Urticaria
228 (.3%)
Back Pain
220 (.29%)
Tachycardia
214 (.28%)
Dry Eye
208 (.27%)
Palpitations
207 (.27%)
Abdominal Pain Upper
202 (.26%)
Dyspnoea Exertional
201 (.26%)
Lung Disorder
196 (.26%)
Emphysema
189 (.25%)
Weight Increased
188 (.25%)
Glaucoma
187 (.24%)
Glossodynia
184 (.24%)
Vomiting
183 (.24%)
Epistaxis
182 (.24%)
Blood Pressure Increased
178 (.23%)
Nervousness
178 (.23%)
Muscle Spasms
177 (.23%)
Arthralgia
174 (.23%)
Visual Acuity Reduced
171 (.22%)
Pyrexia
170 (.22%)
Respiratory Failure
170 (.22%)
Cardiac Failure
169 (.22%)
Weight Decreased
161 (.21%)
Visual Impairment
159 (.21%)
Aphonia
156 (.2%)
Blood Cholesterol Increased
156 (.2%)
Myalgia
155 (.2%)
Cerebrovascular Accident
153 (.2%)
Alopecia
152 (.2%)
Rhinorrhoea
150 (.2%)
Cardiac Disorder
148 (.19%)
Stomatitis
146 (.19%)
Therapeutic Response Decreased
145 (.19%)
Pulmonary Congestion
144 (.19%)
Swelling Face
144 (.19%)
Candidiasis
143 (.19%)
Gastrooesophageal Reflux Disease
141 (.18%)
Pharyngeal Oedema
141 (.18%)
Dyspepsia
139 (.18%)
Adverse Drug Reaction
136 (.18%)
Lung Infection
133 (.17%)
Nasal Congestion
132 (.17%)
Pollakiuria
132 (.17%)
Laryngitis
130 (.17%)

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This graph shows the top adverse events submitted to the FDA for Tiotropium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tiotropium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Tiotropium

What are the most common Tiotropium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Tiotropium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Tiotropium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Tiotropium According to Those Reporting Adverse Events

Why are people taking Tiotropium, according to those reporting adverse events to the FDA?

Chronic Obstructive Pulmonary Disea...
18235
Emphysema
3043
Asthma
2381
Dyspnoea
1093
Chronic Obstructive Airways Disease
965
Drug Use For Unknown Indication
960
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Product Used For Unknown Indication
908
Bronchitis Chronic
645
Bronchitis
277
Lung Disorder
251
Respiratory Disorder
98
Cough
93
Lung Neoplasm Malignant
88
Bronchiectasis
83
Wheezing
64
Pneumonia
62
Pulmonary Fibrosis
59
Hypersensitivity
39
Bronchospasm
35
Asbestosis
33
Bronchial Disorder
31
Ill-defined Disorder
29
Obstructive Airways Disorder
28
Pulmonary Congestion
26
Interstitial Lung Disease
26
Pulmonary Hypertension
25
Respiratory Failure
25
Bronchopneumopathy
20
Sarcoidosis
19
Multiple Allergies
16
Oxygen Saturation Decreased
15
Tuberculosis
15
Chronic Respiratory Failure
14
Prophylaxis
13
Respiration Abnormal
12
Sleep Apnoea Syndrome
12
Exposure To Chemical Pollution
12
Tobacco User
11
Cardiac Failure Congestive
11
Influenza
10
Lung Infection
10
Cystic Fibrosis
10
Pulmonary Function Test Decreased
9
Dyspnoea Exertional
9
Fibrosis
9
Increased Upper Airway Secretion
8
Lung Lobectomy
8
Cardiac Failure
7
Bronchial Hyperreactivity
7
Small Cell Lung Cancer Stage Unspec...
7
Inhalation Therapy
6

Drug Labels

LabelLabelerEffective
SpirivaPhysicians Total Care, Inc.18-MAR-10
SpirivaBoehringer Ingelheim Pharmaceuticals Inc.19-MAR-12
SpirivaLake Erie Medical & Surgical Supply DBA Quality Care Products LLC31-MAY-12

Tiotropium Case Reports

What Tiotropium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Tiotropium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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