A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Elocon Side Effects, and Drug Interactions - Mometasone Furoate (nasal spray)
Elocon Side Effects, and Drug Interactions - Mometasone Furoate (nasal spray)
SIDE EFFECTS
In controlled US and International clinical
studies, a total of 3210 patients received treatment
with NASONEX Nasal Spray, 50 µg at doses of 50 to 800 µg/day.
The majority of patients (n = 2103) were treated with 200 µg/day.
A total of 350 patients have been treated for 1 year or longer.
The overall incidence
of adverse events for patients treated with NASONEX Nasal Spray,
50 µg was comparable to patients treated with the vehicle
placebo. Also, adverse events did not differ significantly based
on age, sex, or race. Three
percent of patients
in clinical trials
discontinued treatment
because of adverse events; this rate
was similar for the vehicle
and active comparators.
All adverse events reported by 5% or more of patients (regardless
of relationship to treatment) who received NASONEX Nasal Spray,
50 µg 200 µg/day in clinical
trials, and that were more common with NASONEX Nasal Spray, 50 µg
than placebo, are displayed
in the table below.
ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL
ALLERGIC AND PERENNIAL ALLERGIC RHINITIS
(PERCENT OF PATIENTS REPORTING)
|
|
NASONEX
NASAL SPRAY, 50 µg
200 µg
(N= 2103)
|
VEHICLE
PLACEBO
(N= 1671)
|
| Headache |
26
|
22
|
| Viral Infection |
14
|
11
|
| Pharyngitis |
12
|
10
|
| Epistaxis/ Blood-Tinged
Mucus |
11
|
6
|
| Coughing |
7
|
6
|
| Upper Respiratory
Tract Infection |
6
|
2
|
| Dysmenorrhea |
5
|
3
|
| Musculoskeletal Pain
|
5
|
3
|
| Sinusitis |
5
|
3
|
Other adverse events which occurred in less than 5% but greater
than or equal to 2% of mometasone-treated patients (regardless of
relationship to treatment), and more frequently than in the placebo
group included: arthralgia,
asthma, bronchitis,
chest pain,
conjunctivitis,
diarrhea, dyspepsia,
earache, flu-like symptoms, myalgia,
nausea, and rhinitis.
Rare cases of nasal ulcers
and nasal and oral
candidiasis were
also reported in patients treated with NASONEX Nasal Spray, 50 µg,
primarily in patients treated for longer than 4 weeks.
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