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SPIRIVA

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Spiriva Adverse Events Reported to the FDA Over Time

How are Spiriva adverse event reports trending over time?

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

Most Common Spiriva Adverse Events Reported to the FDA

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

Incorrect Route Of Drug Administrat...
11855 (15.68%)
Dyspnoea
5279 (6.98%)
Drug Ineffective
4259 (5.63%)
Dry Mouth
1863 (2.46%)
Cough
1386 (1.83%)
Pneumonia
1015 (1.34%)
Dysphonia
884 (1.17%)
Vision Blurred
815 (1.08%)
Chronic Obstructive Pulmonary Disea...
803 (1.06%)
Constipation
659 (.87%)
Dizziness
596 (.79%)
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Urinary Retention
567 (.75%)
Headache
548 (.73%)
Death
527 (.7%)
Chest Discomfort
502 (.66%)
Nausea
478 (.63%)
Ageusia
455 (.6%)
Dysuria
442 (.58%)
Chest Pain
439 (.58%)
Rash
434 (.57%)
Dysgeusia
424 (.56%)
Fatigue
415 (.55%)
Bronchitis
406 (.54%)
Asthenia
405 (.54%)
Malaise
397 (.53%)
Wheezing
397 (.53%)
Eye Pain
351 (.46%)
Lung Neoplasm Malignant
346 (.46%)
Oedema Peripheral
346 (.46%)
Myocardial Infarction
329 (.44%)
Oropharyngeal Pain
328 (.43%)
Pruritus
306 (.4%)
Throat Irritation
306 (.4%)
Insomnia
290 (.38%)
Hypersensitivity
279 (.37%)
Feeling Abnormal
278 (.37%)
Hypertension
268 (.35%)
Urinary Tract Infection
268 (.35%)
Cataract
267 (.35%)
Diarrhoea
266 (.35%)
Increased Upper Airway Secretion
266 (.35%)
Swollen Tongue
265 (.35%)
Heart Rate Increased
264 (.35%)
Fall
257 (.34%)
Condition Aggravated
250 (.33%)
Pain In Extremity
249 (.33%)
Productive Cough
247 (.33%)
Pain
246 (.33%)
Drug Effect Decreased
244 (.32%)
Asthma
243 (.32%)
Anxiety
240 (.32%)
Tremor
236 (.31%)
Dysphagia
233 (.31%)
Nasopharyngitis
231 (.31%)
Dry Throat
229 (.3%)
Atrial Fibrillation
228 (.3%)
Cardiac Failure Congestive
225 (.3%)
Urticaria
225 (.3%)
Back Pain
217 (.29%)
Dry Eye
208 (.28%)
Tachycardia
205 (.27%)
Palpitations
204 (.27%)
Abdominal Pain Upper
202 (.27%)
Dyspnoea Exertional
201 (.27%)
Lung Disorder
195 (.26%)
Weight Increased
188 (.25%)
Glaucoma
187 (.25%)
Glossodynia
184 (.24%)
Emphysema
182 (.24%)
Vomiting
182 (.24%)
Epistaxis
180 (.24%)
Nervousness
178 (.24%)
Blood Pressure Increased
177 (.23%)
Muscle Spasms
177 (.23%)
Arthralgia
174 (.23%)
Visual Acuity Reduced
171 (.23%)
Pyrexia
164 (.22%)
Cardiac Failure
162 (.21%)
Visual Impairment
159 (.21%)
Weight Decreased
157 (.21%)
Aphonia
156 (.21%)
Blood Cholesterol Increased
156 (.21%)
Myalgia
155 (.21%)
Respiratory Failure
154 (.2%)
Cerebrovascular Accident
153 (.2%)
Alopecia
152 (.2%)
Rhinorrhoea
150 (.2%)
Cardiac Disorder
147 (.19%)
Stomatitis
146 (.19%)
Therapeutic Response Decreased
145 (.19%)
Pulmonary Congestion
144 (.19%)
Candidiasis
143 (.19%)
Swelling Face
142 (.19%)
Gastrooesophageal Reflux Disease
141 (.19%)
Pharyngeal Oedema
141 (.19%)
Dyspepsia
139 (.18%)
Adverse Drug Reaction
136 (.18%)
Lung Infection
133 (.18%)
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 Spiriva, 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 Spiriva 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 Spiriva

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

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This graph shows the top categories of adverse events submitted to the FDA for Spiriva, 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 Spiriva 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 Spiriva According to Those Reporting Adverse Events

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

Chronic Obstructive Pulmonary Disea...
17887
Emphysema
3033
Asthma
2346
Dyspnoea
1089
Chronic Obstructive Airways Disease
956
Drug Use For Unknown Indication
877
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Product Used For Unknown Indication
842
Bronchitis Chronic
645
Bronchitis
275
Lung Disorder
249
Respiratory Disorder
98
Cough
93
Lung Neoplasm Malignant
88
Bronchiectasis
83
Pneumonia
62
Wheezing
62
Pulmonary Fibrosis
59
Hypersensitivity
39
Bronchospasm
33
Asbestosis
33
Bronchial Disorder
31
Obstructive Airways Disorder
28
Pulmonary Congestion
26
Pulmonary Hypertension
25
Respiratory Failure
24
Ill-defined Disorder
21
Bronchopneumopathy
20
Sarcoidosis
19
Interstitial Lung Disease
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
Lung Infection
10
Influenza
10
Pulmonary Function Test Decreased
9
Dyspnoea Exertional
9
Fibrosis
9
Increased Upper Airway Secretion
8
Lung Lobectomy
8
Small Cell Lung Cancer Stage Unspec...
7
Cardiac Failure
7
Inhalation Therapy
6
Idiopathic Pulmonary Fibrosis
6
Bronchial Hyperreactivity
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

Spiriva Case Reports

What Spiriva 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 Spiriva. 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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