Drug Safety Information for FLONASE (Fluticasone propionate)
Safety-related Labeling Changes for CUTIVATE (FLUTICASONE PROPIONATE) Rx Drug: FDA Link
Safety-related Labeling Changes for FLONASE (FLUTICASONE PROPIONATE) Over-the-counter Drug: FDA Link
Safety-related Labeling Changes for FLOVENT DISKUS 100 (FLUTICASONE PROPIONATE) Rx Drug: FDA Link
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 FLOVENT HFA (FLUTICASONE PROPIONATE) 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
Safety-related Labeling Changes for XHANCE (FLUTICASONE PROPIONATE) Rx Drug: FDA Link
Adverse Drug Reactions for FLONASE* (Fluticasone propionate)
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 FLONASE
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug ineffective | 3903 |
2 | Dyspnoea | 3710 |
3 | Nausea | 2249 |
4 | Product quality issue | 2188 |
5 | Headache* | 2139 |
6 | Fatigue | 2062 |
7 | Asthma | 1943 |
8 | Cough* | 1865 |
9 | Pain | 1844 |
10 | Dizziness* | 1819 |
11 | Pneumonia | 1564 |
12 | Diarrhoea | 1505 |
13 | Vomiting | 1381 |
14 | Anxiety* | 1367 |
15 | Asthenia | 1296 |
16 | Malaise | 1240 |
17 | Chest pain | 1170 |
18 | Pyrexia | 1097 |
19 | Fall | 1096 |
20 | Arthralgia | 1091 |
* This side effect also appears in "Top 10 Side Effects of FLONASE " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking FLONASE
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Product used for unknown indication | 23210 |
2 | Asthma* | 16981 |
3 | Hypersensitivity* | 7773 |
4 | Chronic obstructive pulmonary disease | 4485 |
5 | Multiple allergies | 2493 |
6 | Seasonal allergy* | 2214 |
7 | Rhinitis allergic* | 2106 |
8 | Sinus disorder | 1035 |
9 | Dyspnoea | 953 |
10 | Nasal congestion* | 916 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for FLONASE
Total Reports Filed with FDA: 196743
Number of FDA Adverse Event Reports by Patient Age for FLONASE
Total Reports Filed with FDA: 196743*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluticasone propionate (Flovent diskus 50, Flovent diskus 250, Fluticasone, Fluticasona, Floventhfa, Flovent diskus 100, Flovent, Cutivate, Flovent hfa, Flonase)
Charts are based on 196743 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.
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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.