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Azmacort

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Azmacort

Azmacort

Azmacort Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Azmacort (triamcinolone acetonide) Inhalation Aerosol is a corticosteroid used to prevent asthma attacks. Common side effects of Azmacort include nausea, diarrhea, stomach pain, joint or muscle pain, dryness in your mouth, nose, or throat, white patches or sores inside your mouth or on your lips, stuffy nose, sinus pain, sore throat, cough, and hoarseness or deepened voice.

The recommended dosage of Azmacort is two inhalations (150 mcg) given three to four times per day or four inhalations (300 mcg) given twice daily. Other drugs may interact with Azmacort. Tell your doctor all medications you are taking. Contact your doctor if your asthma medication is not working as well as usual as this may be an early sign of a serious asthma attack. Do not stop taking Azmacort unless directed to do so by your doctor. Talk to your doctor you are pregnant and taking Azmacort as you should only use Azmacort if the potential benefit outweighs the risk to the fetus. Consult your doctor before breastfeeding.

Our Azmacort (triamcinolone acetonide) Inhalation Aerosol Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Azmacort in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • wheezing or breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • pain or burning when you urinate;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
  • worsening asthma symptoms.

Less serious side effects may include:

  • nausea, diarrhea, stomach pain;
  • joint or muscle pain;
  • dryness in your mouth, nose, or throat;
  • white patches or sores inside your mouth or on your lips;
  • stuffy nose, sinus pain, sore throat, cough; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Azmacort (Triamcinolone Acetonide (inhalation aerosol)) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Azmacort FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 (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
bid
(n=57)
Azmacort (triamcinolone acetonide (inhalation aerosol)) Dose
300 mcg bid
(n=170)
600 mcg
bid
(n=57)
Placebo
(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 (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.

Read the entire FDA prescribing information for Azmacort (Triamcinolone Acetonide (inhalation aerosol)) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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