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
Azmacort Side Effects, and Drug Interactions - Triamcinolone Acetonide (inhalation aerosol)
Azmacort Side Effects, and Drug Interactions - Triamcinolone Acetonide (inhalation aerosol)
SIDE EFFECTS
The table below describes
the incidence of common
adverse experiences based upon three placebo-controlled, multicenter
US clinical trials
of 507 patients (297 female
and 210 male adults (age
range 18-64)). These trials
included asthma patients
who had previously received inhaled beta2-agonists alone,
as well as those who previously required inhaled corticosteroid
therapy for the control
of their asthma. The patients were treated with Azmacort Inhalation
Aerosol (including doses ranging from 200 to 800 mcg twice daily
for 6 weeks) or placebo.
Adverse Events Occurring at an Incidence of Greater Than 3%
and Greater Than Placebo
| Adverse Event |
Azmacort Dose |
Placebo |
200 mcg
bid
(n=57) |
400 mcg
bid
(n=170) |
800 mcg
bid
(n=57) |
(n=167) |
| Sinusitis |
5 (9%) |
7 (4%) |
1 (2%) |
6 (4%) |
| Pharyngitis |
4 (7%) |
42 (25%) |
10 (18%) |
19 (11%) |
| Headache |
4 (7%) |
35 (21%) |
7 (12%) |
24 (14%) |
| Flu Syndrome |
2 (4%) |
8 (5%) |
1 (2%) |
5 (3%) |
| Back Pain |
2 (4%) |
3 (2%) |
2 (4%) |
3 (2%) |
Adverse events that occurred at an incidence
of 1-3% in the overall Azmacort Inhalation Aerosol treatment
group and greater than
placebo included:
Body as a whole: facial
edema, pain,
abdominal pain, photosensitivity
Digestive system: diarrhea,
oral monilia, toothache,
vomiting
Metabolic and Nutrition: weight
gain
Musculoskeletal system: bursitis,
myalgia, tenosynovitis
Nervous system: dry mouth
Organs of special sense: rash
Respiratory system: chest
congestion, voice alteration
Urogenital system: cystitis,
urinary tract
infection, vaginal monilia
In older controlled clinical
trials of steroid dependent
asthmatics, urticaria was reported rarely. Anaphylaxis was not reported
in these controlled trials. Typical steroid
withdrawal effects
including muscle aches,
joint aches, and fatigue
were noted in clinical
trials when patients were transferred from oral
steroid therapy
to Azmacort Inhalation Aerosol. Easy bruisability was also noted
in these trials.
Hoarseness, dry throat,
irritated throat, dry
mouth, facial
edema, increased wheezing,
and cough have been reported.
These adverse effects have generally been mild and transient. Cases
of oral candidiasis
occurring with clinical use have been reported. (See WARNINGS.)
Post Marketing: In addition to adverse events reported from clinical trials, the following
events have been reported post marketing: anaphylaxis, cataracts, and glaucoma.
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