Drug Safety Information for NASONEX (Mometasone furoate monohydrate)

Safety-related Labeling Changes for NASONEX (MOMETASONE FUROATE MONOHYDRATE) Rx Drug: FDA Link

Adverse Drug Reactions for NASONEX* (Mometasone furoate monohydrate)

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 NASONEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea581
2Nausea517
3Drug ineffective459
4Fatigue456
5Headache445
6Product quality issue426
7Dizziness373
8Pain361
9Cough340
10Anxiety338
11Vomiting303
12Drug dose omission285
13Depression285
14Asthma280
15Diarrhoea272
16Asthenia267
17Chest pain262
18Arthralgia260
19Insomnia256
20Pain in extremity245

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

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

Reason # of FDA Reports
1Product used for unknown indication4074
2Hypersensitivity1810
3Multiple allergies793
4Rhinitis allergic578
5Seasonal allergy558
6Rhinitis437
7Sinusitis403
8Sinus disorder383
9Asthma290
10Nasal congestion274

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


Types of Adverse Events for NASONEX

Total Reports Filed with FDA: 41313


Number of FDA Adverse Event Reports by Patient Age for NASONEX

Total Reports Filed with FDA: 41313*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Mometasone furoate monohydrate (Nasonex)

Charts are based on 41313 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 NASONEX 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.