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 12–83 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) |
|---|
| Headache | 22 | 17 | 20 | 20 |
| Allergic Rhinitis | 15 | 11 | 14 | 13 |
| Pharyngitis | 11 | 8 | 13 | 7 |
| Upper Respiratory Inf. | 10 | 8 | 15 | 7 |
| Sinusitis | 6 | 6 | 5 | 5 |
| Candidiasis, oral | 6 | 4 | 4 | 2 |
| DysmenorrheaPercentages are based on the number of female patients. | 9 | 4 | 4 | 4 |
| Musculoskeletal Pain | 8 | 4 | 4 | 5 |
| Back Pain | 6 | 3 | 3 | 4 |
| Dyspepsia | 5 | 3 | 3 | 3 |
| Myalgia | 3 | 2 | 3 | 2 |
| Abdominal Pain | 3 | 2 | 3 | 2 |
| Nausea | 3 | 1 | 3 | 2 |
| Average Duration of Exposure (Days) | 81 | 70 | 80 | 62 |
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.
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