Drug Safety Information for COMBIVENT (Albuterol sulfate; ipratropium bromide)

Safety-related Labeling Changes for COMBIVENT RESPIMAT (ALBUTEROL SULFATE; IPRATROPIUM BROMIDE) Rx Drug: FDA Link

Adverse Drug Reactions for COMBIVENT* (Albuterol sulfate; 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 COMBIVENT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea3300
2Drug ineffective2020
3Product quality issue1564
4Pneumonia1275
5Off label use1239
6Cough*1149
7Chronic obstructive pulmonary disease1041
8Nausea928
9Dizziness737
10Asthenia717
11Fatigue712
12Overdose696
13Chest pain668
14Headache638
15Asthma623
16Pain*618
17Fall575
18Anxiety565
19Diarrhoea560
20Vomiting549

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

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

Reason # of FDA Reports
1Chronic obstructive pulmonary disease*11640
2Product used for unknown indication6588
3Asthma*5118
4Dyspnoea2124
5Emphysema*1513
6Wheezing455
7Bronchitis*412
8Bronchitis chronic383
9Lung disorder246
10Pneumonia152

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


Types of Adverse Events for COMBIVENT

Total Reports Filed with FDA: 94688


Number of FDA Adverse Event Reports by Patient Age for COMBIVENT

Total Reports Filed with FDA: 94688*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Albuterol sulfate; ipratropium bromide (Combivent respimat, Combivent, Duoneb)

Charts are based on 94688 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 COMBIVENT 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.