Drug Safety Information for VERAMYST (Fluticasone furoate)

Safety-related Labeling Changes for BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE) Rx Drug: FDA Link

Safety-related Labeling Changes for ARNUITY ELLIPTA (FLUTICASONE FUROATE) Rx Drug: FDA Link

Safety-related Labeling Changes for TRELEGY ELLIPTA (FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE) Rx Drug: FDA Link

Adverse Drug Reactions for VERAMYST* (Fluticasone furoate)

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 VERAMYST
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective243
2Epistaxis176
3Product quality issue151
4Headache*145
5Dyspnoea119
6Dizziness*84
7Pain*83
8Cough81
9Nausea79
10Sinusitis72
11Anxiety*62
12Nasal discomfort61
13Rash61
14Malaise59
15Asthma58
16Nasal congestion51
17Fatigue51
18Oropharyngeal pain50
19Back pain*48
20Vision blurred*46

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

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

Reason # of FDA Reports
1Product used for unknown indication1031
2Multiple allergies346
3Rhinitis allergic*339
4Hypersensitivity251
5Nasal congestion*127
6Sinus disorder109
7Sinusitis96
8Seasonal allergy81
9Asthma78
10Rhinitis56

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


Types of Adverse Events for VERAMYST

Total Reports Filed with FDA: 7159


Number of FDA Adverse Event Reports by Patient Age for VERAMYST

Total Reports Filed with FDA: 7159*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluticasone furoate (Arnuity ellipta, Veramyst)

Charts are based on 7159 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 VERAMYST 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.