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Asmanex (Mometasone Furoate Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following incidence of common adverse experiences is based on double-blind data from ten placebo-controlled clinical trials involving a total of 2809 patients previously maintained on inhaled steroids and/or bronchodilators (1140 males, 1669 females, age 1283 years), who were treated for up to 12 weeks with the ASMANEX TWISTHALER product, an active comparator, or placebo. Adverse events were generally mild to moderate in severity.

ADVERSE EVENTS WITH ≥3% INCIDENCE IN CONTROLLED CLINICAL TRIALS WITH ASMANEX TWISTHALER IN PATIENTS PREVIOUSLY ON BRONCHODILATORS AND/OR INHALED CORTICOSTEROIDS
Adverse Event(%) of Patients
MF DPI
220 mcg
BID
(n=443)
440 mcg
QD
(n=497)
220 mcg
QD PM
(n=232)
Placebo

(n=720)
Headache22172020
Allergic Rhinitis15111413
Pharyngitis118137
Upper Respiratory Inf.108157
Sinusitis6655
Candidiasis, oral6442
DysmenorrheaPercentages are based on the number of female patients.9444
Musculoskeletal Pain8445
Back Pain6334
Dyspepsia5333
Myalgia3232
Abdominal Pain3232
Nausea3132
Average Duration of Exposure (Days)81708062

The table above includes all events (whether considered drug-related or nondrug-related by the investigators) that occurred at a rate of ≥3% in any one mometasone furoate group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for ASMANEX TWISTHALER patients should be taken into account.

The following other adverse events occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on ASMANEX TWISTHALER therapy than on placebo:

Body as a Whole: fatigue, flu-like symptoms, fever, accidental injury, pain, post-procedure pain

Gastrointestinal: flatulence, gastroenteritis, vomiting, anorexia

Hearing, Vestibular: earache

Psychiatric: insomnia

Reproductive, Female: menstrual disorder

Resistance Mechanism: infection

Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry

Skin and Appendages: insect bite, skin laceration

Urinary: urinary tract infection

In a 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of ASMANEX TWISTHALER therapy administered as two 220 mcg inhalations twice daily (N=46) were compared with those of placebo (N=43). Adverse events, whether considered drug related or not by the investigators, reported in more than 3 patients in the ASMANEX TWISTHALER treatment group, and which occurred more frequently than on placebo were (ASMANEX TWISTHALER % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on ASMANEX TWISTHALER treatment (77 days vs. 58 days on placebo) should be taken into account.

Cases of growth suppression and decreased bone mineral density have been reported for orally inhaled corticosteroids, including mometasone furoate inhalation powder.

Drug label data at the top of this Page last updated: 2006-06-05

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