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Asmanex Twisthaler

Last reviewed on RxList: 9/21/2015
Asmanex Side Effects Center

Last reviewed on RxList 11/30/2016

Asmanex HFA (mometasone furoate) Inhalation Aerosol is a corticosteroid used as maintenance treatment for the prevention and control of asthma symptoms in people 12 years of age and older. Common side effects of Asmanex HFA include:

Asmanex HFA comes in 2 strengths. The dose of Asmanex HFA is 2 puffs in the morning and 2 puffs in the evening. Asmanex HFA may interact with antifungal medicines and anti-HIV medicines. Tell your doctor all medications and supplements you use. It is unknown if Asmanex HFA would affect a fetus. Tell your doctor if you are pregnant or plan to become pregnant before using Asmanex HFA. It is unknown if Asmanex HFA passes into breast milk. Consult your doctor before breastfeeding.

Our Asmanex HFA (mometasone furoate) 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.

Asmanex Consumer Information

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

Call your doctor at once if you have a serious side effect such as:

  • wheezing, choking, or other breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist); or
  • worsening asthma symptoms.

Less serious side effects may include:

  • headache;
  • increased sinus allergy symptoms (runny nose, stuffy nose, sinus pain), sore throat, nosebleed;
  • muscle or joint pain, back pain;
  • nausea, upset stomach, loss of appetite;
  • changes in menstrual periods;
  • tired feeling; or
  • hoarseness or deepened voice.

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.

Read the entire detailed patient monograph for Asmanex (Mometasone Furoate)

Asmanex Professional Information

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ASMANEX HFA was evaluated in 2 randomized placebo and active-controlled trials of 12 and 26 weeks' duration, conducted as part of a mometasone furoate/formoterol fumarate combination product asthma program, which enrolled 1509 patients with persistent asthma. Patient ages ranged from 12 to 84 years of age, 41% were male and 59% female, 73% were Caucasian and 27% non-Caucasian. Of the total population enrolled in the 2 trials, 432 patients received two inhalations twice daily of either ASMANEX HFA, 100 mcg or 200 mcg/actuation. In the 26-week trial (Trial 1) 192 patients received two inhalations twice daily of ASMANEX HFA 100 mcg/actuation and 196 patients received placebo. In the 12 week trial (Trial 2) 240 patients received two inhalations twice daily of ASMANEX HFA 200 mcg/actuation and 233 and 255 patients received mometasone furoate and formoterol fumarate 100 mcg/5 mcg and 200 mcg/5 mcg/actuation combination products, respectively, as comparators.

In these trials, the proportion of patients who discontinued study treatment early due to adverse reactions was 3% and 2% for ASMANEX HFA 100 and 200 mcg treated patients, respectively, and 4% for placebo-treated patients. Serious adverse reactions, whether considered drug-related or not by the investigators, which occurred more frequently in ASMANEX HFA-treated patients included colitis ulcerative, colonic polyp, chest pain, gastroenteritis, endometriosis, asthma, and hemoptysis; all events occurred at rates less than 1%.

The incidence of treatment emergent adverse reactions associated with ASMANEX HFA are shown in Tables 2 and 3. These are based upon data from each of the 2 clinical trials of 12 or 26 weeks in duration in patients 12 years and older treated with two inhalations twice daily of ASMANEX HFA (100 mcg or 200 mcg), mometasone furoate/formoterol fumarate (100 mcg/5 mcg or 200 mcg/5 mcg), or placebo.

TABLE 2: Trial 1: Treatment-Emergent Adverse Reactions Occurring at an Incidence of ≥ 3% and More Commonly than Placebo Over 26 Weeks

  ASMANEX HFA 100 mcg
N=192
n (%)
Placebo
N=196
n (%)
Nasopharyngitis 15 (8) 7 (4)
Headache 10 (5) 7 (4)
Influenza 7 (4) 5 (3)
Sinusitis 6 (3) 2 (1)

TABLE 3: Trial 2: Treatment-Emergent Adverse Reactions Occurring at an Incidence of ≥ 3% Over 12 Weeks

  ASMANEX HFA 200 mcg
N=240
n (%)
MF/F* 100/5 mcg
N=233
n (%)
MF/F* 200/5 mcg
N=255
n (%)
Nasopharyngitis 13 (5) 8 (3) 12 (5)
Headache 8 (3) 10 (4) 5 (2)
Bronchitis 6 (3) 2 (1) 7 (3)
*MF/F = mometasone furoate/formoterol fumarate

Oral candidiasis has been reported in clinical trials at an incidence of 0.5% in patients using ASMANEX HFA 100 mcg, 0.8% in patients using ASMANEX HFA 200 mcg and 0.5% in the placebo group.

Postmarketing Experience

There are no postmarketing adverse experiences reported to date with ASMANEX HFA. However, the postmarketing safety experience with mometasone furoate dry powder inhaler is relevant to ASMANEX HFA since they contain the same active ingredient. The following adverse reactions have been reported during post-approval use of mometasone furoate dry powder inhaler. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders

Immediate and delayed hypersensitivity reactions including rash, pruritus, angioedema and anaphylactic reaction [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Respiratory, Thoracic and Mediastinal Disorders

Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.

Read the entire FDA prescribing information for Asmanex (Mometasone Furoate)

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© Asmanex Patient Information is supplied by Cerner Multum, Inc. and Asmanex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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