Side Effects of Azmacort (triamcinolone)

Azmacort (triamcinolone inhaler) is a glucocorticoid steroid medication used for the treatment of asthma. Azmacort should not be used for acute asthma attacks. 

Glucocorticoids have potent anti-inflammatory actions. Some symptoms of asthma are caused by chronic inflammation in the airways within the lungs that obstruct the flow of air into and out of the lungs. 

Azmacort reduces inflammation in the lungs and airways and thereby improves breathing in individuals with asthma. When used as an inhaler, Azmacort goes directly to the airways of the lungs, and very little is absorbed into the body.

Common side effects of Azmacort include:

• headache,
• sore throat,
• vomiting,
• dry mouth,
• cough,
• oral thrush, and
• hoarseness.

Serious side effects of Azmacort include:

• decreased formation of bone and increased breakdown (resorption) of bone leading to weak bones and fractures when taken at high doses and
• suppression of the body's ability to make its own natural glucocorticoid in the adrenal glands when taken at very high doses. 

No drug interactions have been described with inhaled Azmacort. 

There are no adequate studies of Azmacort inhaler in pregnant women. It is unknown if Azmacort secreted in breast milk. Other medications in its family are secreted into breast milk, but it is unknown if the small amounts that may appear in milk affect the infant. Consult your doctor before breastfeeding. 

Common side effects are:

• headache,
• pharyngitis (inflammation of the throat),
• vomiting,
• dry mouth, and
• cough.

Mild cough or wheezing due to chemical irritation may be minimized by using an inhaled bronchodilator, for example, albuterol (Ventolin), prior to using the triamcinolone.

Oral candidiasis or thrush (a fungal infection) may occur in 1 in 20 to 1 in 10 persons who use triamcinolone, the risk being higher with higher doses. The risk of thrush in children is lower than in adults. Hoarseness also may result from the use of triamcinolone inhaler.

Using a spacer (a device that is attached to the inhaler) and washing the mouth out with water following each use reduces the risk of thrush and hoarseness.

High doses of inhaled glucocorticoids may decrease the formation of bone and increase the breakdown (resorption) of bone leading to weak bones and fractures. Very high doses may cause suppression of the body's ability to make its own natural glucocorticoid in the adrenal glands.

It is possible that patients with suppression of their adrenal glands may need increased amounts of glucocorticoids by the oral or intravenous route during periods of high physical stress such as illnesses when increased amounts of glucocorticoids are needed by the body.

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 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. Cases of growth suppression have been reported for orally inhaled corticosteroids.

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.

No information provided.