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).
|
For the consumer For the professional
|
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:
Seek medical attention right away if any of these SEVERE side effects occur 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.
TopSevere 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.
| Adverse Event | (%) of Patients | |||
|---|---|---|---|---|
| MF DPI | ||||
| 220 mcg BID (n=443) |
440 mcg QD (n=497) |
220 mcg QD PM (n=232) |
Placebo (n=720) |
|
| ||||
| Headache | 22 | 17 | 20 | 20 |
| Allergic Rhinitis | 15 | 11 | 14 | 13 |
| Pharyngitis | 11 | 8 | 13 | 7 |
| Upper Respiratory Inf. | 10 | 8 | 15 | 7 |
| Sinusitis | 6 | 6 | 5 | 5 |
| Candidiasis, oral | 6 | 4 | 4 | 2 |
| Dysmenorrhea* | 9 | 4 | 4 | 4 |
| Musculoskeletal Pain | 8 | 4 | 4 | 5 |
| Back Pain | 6 | 3 | 3 | 4 |
| Dyspepsia | 5 | 3 | 3 | 3 |
| Myalgia | 3 | 2 | 3 | 2 |
| Abdominal Pain | 3 | 2 | 3 | 2 |
| Nausea | 3 | 1 | 3 | 2 |
| Average Duration of Exposure (Days) | 81 | 70 | 80 | 62 |
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.
TopDisclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.




