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Azmacort Inhalation (Triamcinolone Acetonide Inhalation) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Azmacort Dose Placebo
  Event 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.

Drug label data at the top of this Page last updated: 2006-06-18

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