Asmanex Side Effects

Please note - some side effects for Asmanex 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 Asmanex - for the consumer

Asmanex Twisthaler Powder

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 Asmanex Twisthaler Powder:

Decreased appetite; flu-like symptoms; headache; indigestion; nausea; runny nose; sinus swelling; sore throat; stomach pain or upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; lack of energy; menstrual changes; mental or mood changes; muscle or bone pain; new or worsening breathing problems; shakiness; shortness of breath; swelling; tiredness; vision changes; vomiting; weakness; wheezing; white curd-like patches or rash in the mouth.

For the professional

Asmanex

The following incidence of common adverse experiences is based on double-blind data from ten placebo-controlled clinical trials involving a total of 2809 patients previously maintained on inhaled steroids and/or bronchodilators (1140 males, 1669 females, age 12–83 years), who were treated for up to 12 weeks with the Asmanex TWISTHALER product, an active comparator, or placebo. Adverse events were generally mild to moderate in severity.

The table above includes all events (whether considered drug-related or nondrug-related by the investigators) that occurred at a rate of ≥3% in any one mometasone furoate group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Asmanex TWISTHALER patients should be taken into account.

The following other adverse events occurred in these clinical trials with an incidence of at least 1% but less than 3% and were more common on Asmanex TWISTHALER therapy than on placebo:

Body as a Whole: fatigue, flu-like symptoms, fever, accidental injury, pain, post-procedure pain

Gastrointestinal: flatulence, gastroenteritis, vomiting, anorexia

Hearing, Vestibular: earache

Psychiatric: insomnia

Reproductive, Female: menstrual disorder

Resistance Mechanism: infection

Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry

Skin and Appendages: insect bite, skin laceration

Urinary: urinary tract infection

In a 12-week trial in adult asthmatics who previously required oral corticosteroids, the effects of Asmanex TWISTHALER therapy administered as two 220 mcg inhalations twice daily (N=46) were compared with those of placebo (N=43). Adverse events, whether considered drug related or not by the investigators, reported in more than 3 patients in the Asmanex TWISTHALER treatment group, and which occurred more frequently than on placebo were (Asmanex TWISTHALER % vs. placebo %): musculoskeletal pain (22% vs. 14%), oral candidiasis (22% vs. 9%), sinusitis (22% vs. 19%), allergic rhinitis (20% vs. 5%), upper respiratory infection (15% vs. 14%), arthralgia (13% vs. 7%), fatigue (13% vs. 2%), depression (11% vs. 0%), and sinus congestion (9% vs. 0%). In considering these data, an increased duration of exposure for patients on Asmanex TWISTHALER treatment (77 days vs. 58 days on placebo) should be taken into account.

Cases of growth suppression and decreased bone mineral density have been reported for orally inhaled corticosteroids, including mometasone furoate inhalation powder.

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