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 (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol (including doses ranging from 150 to 600 mcg twice daily for 6 weeks) or placebo.
Adverse Events Occurring at an Incidence of Greater Than 3% and Greater Than Placebo
|Adverse Event|| 150 mcg
| Azmacort (triamcinolone acetonide (inhalation aerosol)) Dose
300 mcg bid
| 600 mcg
|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 (triamcinolone acetonide (inhalation aerosol)) 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 (triamcinolone acetonide (inhalation aerosol)) 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.) Cases of growth suppression have been reported for orally inhaled corticosteroids (see PRECAUTIONS, Pediatric Use section).
Post Marketing: In addition to adverse events reported from clinical trials, the following events have been identified during post approval use of Azmacort (triamcinolone acetonide (inhalation aerosol)) Inhalation Aerosol where these events were reported voluntarily from a population of unknown size, and the frequency of occurrence cannot be determined precisely. These include rare reports of anaphylaxis, cataracts, glaucoma and very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.