Azmacort Side Effects

Generic Name: triamcinolone

Please note - some side effects for Azmacort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Azmacort - for the Consumer

Azmacort Aerosol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Azmacort Aerosol:

Back pain; dry mouth; flu-like symptoms; headache, hoarseness; irritated or sore throat; sinus inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest congestion; depression; exhaustion; fainting; muscle and joint pain; severe dizziness; sudden weight loss; unusual weakness; white, curd-like patches in mouth.

Azmacort Side Effects - for the Professional

Azmacort

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 150 to 600 mcg twice daily for 6 weeks) or placebo.

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. 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 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.

Side Effects by Body System

Cardiovascular

Cardiovascular side effects have included fluid retention, sodium retention, congestive heart failure, potassium loss, hypokalemic alkalosis, and hypertension.

Musculoskeletal

Decreases in bone density of the total hip and the trochanter have been reported with the use of inhaled triamcinolone acetonide in a study (n=109) of premenopausal women with asthma. The yearly change in bone density at the total hip and the trochanter showed a greater decline as the number of puffs per day of the inhaled glucocorticoid increased.

Musculoskeletal side effects have included aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intra-lesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, and vertebral compression fractures. Postmarketing experience has included very rare reports of bone mineral density loss and osteoporosis, especially with prolonged use, which may lead to an increased risk of fractures.

Gastrointestinal

Gastrointestinal side effects have included peptic ulcer with potential perforation and hemorrhage, perforation of small and large bowel, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic

Dermatologic side effects have included impaired wound healing, thin, fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, and suppressed reactions to skin tests.

Nervous system

Nervous system side effects have included convulsions, increased intracranial pressure with papilledema, vertigo, and headache.

Endocrine

Endocrine side effects have included development of cushingoid state, menstrual irregularities, suppression of growth in children, manifestations of latent diabetes, increased requirements for insulin or oral hypoglycemic agents in diabetics, decreased carbohydrate tolerance, and secondary adrenocortical and pituitary unresponsiveness.

Ocular

Ocular side effects have included posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos. Retinal and choroidal occlusion as a complication after posterior sub-Tenon triamcinolone injection has been reported.

Metabolic

Metabolic side effects have included negative nitrogen balance due to protein catabolism.

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