Drug Safety Information for SPIRIVA (Tiotropium bromide monohydrate)

Safety-related Labeling Changes for SPIRIVA (TIOTROPIUM BROMIDE MONOHYDRATE) Rx Drug: FDA Link

Adverse Drug Reactions for SPIRIVA* (Tiotropium bromide monohydrate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SPIRIVA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Incorrect route of drug administration17355
2Dyspnoea9044
3Drug ineffective4527
4Product quality issue3361
5Pneumonia3027
6Chronic obstructive pulmonary disease2769
7Cough2514
8Dry mouth*1922
9Nausea1891
10Off label use1710
11Fatigue1568
12Dizziness1546
13Death1463
14Headache*1436
15Malaise1338
16Dysphonia1306
17Asthenia1302
18Fall1301
19Diarrhoea1295
20Chest pain1127

* This side effect also appears in "Top 10 Side Effects of SPIRIVA " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SPIRIVA
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Chronic obstructive pulmonary disease*58015
2Product used for unknown indication16608
3Emphysema*7944
4Asthma*6448
5Dyspnoea3436
6Bronchitis chronic2019
7Lung disorder1040
8Bronchitis789
9Respiratory disorder446
10Bronchiectasis317

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SPIRIVA

Total Reports Filed with FDA: 202798


Number of FDA Adverse Event Reports by Patient Age for SPIRIVA

Total Reports Filed with FDA: 202798*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tiotropium bromide monohydrate (Tiotropium bromide, Spiriva, Tiotropium)

Charts are based on 202798 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SPIRIVA Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.