Drug Safety Information for ADVAIR HFA (Fluticasone propionate; salmeterol xinafoate)

Safety-related Labeling Changes for ADVAIR DISKUS 100/50 (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ADVAIR HFA (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Safety-related Labeling Changes for AIRDUO RESPICLICK (FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE) Rx Drug: FDA Link

Adverse Drug Reactions for ADVAIR HFA* (Fluticasone propionate; salmeterol xinafoate)

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 ADVAIR HFA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea8808
2Drug ineffective6724
3Product quality issue6075
4Asthma3700
5Cough*3529
6Pneumonia3417
7Nausea2673
8Dysphonia*2663
9Headache2333
10Fatigue2284
11Dizziness2245
12Malaise2160
13Pain*2118
14Chronic obstructive pulmonary disease2054
15Chest pain1628
16Asthenia1607
17Wheezing1557
18Vomiting1520
19Death1503
20Diarrhoea1490

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

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

Reason # of FDA Reports
1Asthma*49394
2Chronic obstructive pulmonary disease*31823
3Product used for unknown indication29325
4Emphysema3602
5Dyspnoea3104
6Bronchitis*1809
7Respiratory disorder922
8Cough*758
9Lung disorder703
10Bronchitis chronic611

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


Types of Adverse Events for ADVAIR HFA

Total Reports Filed with FDA: 250983


Number of FDA Adverse Event Reports by Patient Age for ADVAIR HFA

Total Reports Filed with FDA: 250983*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluticasone propionate; salmeterol xinafoate (Advairdiskus, Advair diskus 100/50, Advair diskus, Advair, Advair hfa, Advair diskus 250/50, Advair diskus 500/50)

Charts are based on 250983 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 ADVAIR HFA 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.