Drug Safety Information for ATROVENT (Ipratropium bromide)

Safety-related Labeling Changes for ATROVENT HFA (IPRATROPIUM BROMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ATROVENT* (Ipratropium bromide)

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 ATROVENT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2057
2Pneumonia1130
3Drug ineffective1024
4Chronic obstructive pulmonary disease872
5Nausea771
6Asthma687
7Fatigue666
8Death*665
9Cough664
10Asthenia630
11Dizziness*593
12Vomiting584
13Pain575
14Diarrhoea550
15Headache*528
16Respiratory failure520
17Pyrexia513
18Chest pain488
19Hypotension480
20Fall473

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

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

Reason # of FDA Reports
1Product used for unknown indication7981
2Chronic obstructive pulmonary disease*4561
3Asthma*3542
4Dyspnoea1160
5Emphysema556
6Pneumonia372
7Rhinorrhoea*345
8Bronchitis*307
9Hypersensitivity269
10Bronchospasm268

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


Types of Adverse Events for ATROVENT

Total Reports Filed with FDA: 87190


Number of FDA Adverse Event Reports by Patient Age for ATROVENT

Total Reports Filed with FDA: 87190*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ipratropium bromide (Itrop, Atrovent hfa, Ipratropio, Atroventhfa, Atrovent forte, Atrovent nasal, Ipratropium, Atrovent, Ipratropium bromide)

Charts are based on 87190 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 ATROVENT 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.