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.
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.
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 or painful menstruation; 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAsmanex Side Effects - for the Professional
Asmanex
Systemic and local corticosteroid use may result in the following:
- Candida albicans infection [see Warnings and Precautions (5.1)]
- Immunosuppression [see Warnings and Precautions (5.4)]
- Hypercorticism and adrenal suppression [see Warnings and Precautions (5.6)]
- Growth effects [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4)]
- Glaucoma and cataracts [see Warnings and Precautions (5.9)]
Clinical Studies Experience
The safety data described below reflect exposure to Asmanex TWISTHALER in 2380 patients with asthma exposed for 8 to 12 weeks and 627 patients with asthma exposed for 1 year in a total of 17 clinical trials.
In adult and adolescent patients 12 years of age and older, Asmanex TWISTHALER was studied in 10 placebo-controlled clinical trials of 8 to 12 weeks duration with a total of 1750 patients receiving Asmanex TWISTHALER. There were also 3 trials with a total of 475 patients receiving Asmanex TWISTHALER for 1 year. In the 8- to 12-week clinical trials, the population was 12 to 83 years of age, 38% males and 62% females, and 83% Caucasian, 8% black, 6% Hispanic, and 3% other race/ethnicity. Patients received Asmanex TWISTHALER 110 mcg twice daily (n=133), 220 mcg once daily in the morning (n=209), 220 mcg once daily in the evening (n=232), 220 mcg twice daily (n=433), 440 mcg once daily in the morning (n=419), 440 mcg once daily in the evening (n=250), or 440 mcg twice daily (n=74). In 3 long-term safety trials (two 9-month extensions of efficacy trials and one 52-week active-controlled safety trial), 475 patients with asthma (12 – 83 years of age, 44% males, 56% females, 87% Caucasian, 8% black, 4% Hispanic, and 1% other race/ethnicity) received various doses of Asmanex TWISTHALER for 1 year.
In pediatric patients 4 to 11 years of age, Asmanex TWISTHALER was studied in 3 placebo-controlled clinical trials of 12 weeks duration with a total of 630 patients receiving Asmanex TWISTHALER and a 52-week, active-controlled safety trial with a total of 152 patients receiving Asmanex TWISTHALER. In the 12-week clinical trials, the population was 4 to 11 years of age, 63% males and 37% females, and 67% Caucasian, 13% black, 17% Hispanic, and 3% other race/ethnicity. Patients received Asmanex TWISTHALER 110 mcg once daily in the evening (n=98), 110 mcg once daily in the morning (n=181), 110 mcg twice daily (n=179), or 220 mcg once daily in the morning (n=172). In the long-term active-controlled safety trial (n=152), patients with asthma (4 to 11 years of age, 60% males and 40% females, 84% Caucasian, 11% Black, and 5% Hispanic) received Asmanex TWISTHALER 110 mcg twice daily or 220 mcg once daily in the morning for 52 weeks.
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.
Adults and Adolescents 12 Years of Age and Older: The safety results of the 10 trials that were 8 to 12 weeks in duration were pooled because patients with asthma in these studies were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results of the one 12-week clinical trial in patients with asthma previously treated with oral corticosteroids are presented separately.
In the pooled 8- to 12-week clinical trials, adverse reactions were reported in 70% of patients treated with Asmanex TWISTHALER (n=1750) compared to 65% of patients taking placebo (n=720). Table 2 displays the common adverse reactions (≥3% in any patient group receiving Asmanex TWISTHALER) that occurred more frequently in patients treated with Asmanex TWISTHALER compared to patients treated with placebo.
| (%) of Patients | ||||
|---|---|---|---|---|
| Asmanex TWISTHALER | ||||
| Adverse Reaction | 220 mcg twice daily (n=433) |
440 mcg once daily (n=497) |
220 mcg once daily in the evening (n=232) |
Placebo (n=720) |
|
||||
| Headache | 22 | 17 | 20 | 20 |
| Allergic Rhinitis | 15 | 11 | 14 | 13 |
| Pharyngitis | 11 | 8 | 13 | 7 |
| Upper Respiratory Infection | 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 following other adverse reactions 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, pain
Gastrointestinal: gastroenteritis, vomiting, anorexia
Hearing, Vestibular: earache
Resistance Mechanism: infection
Respiratory: dysphonia, epistaxis, nasal irritation, respiratory disorder, throat dry
In the 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 reactions, 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 in 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.
Long-Term Clinical Trials Experience - 12 Years of Age and Older: In 3 long-term safety trials, 475 patients with asthma 12 years of age and older were treated with Asmanex TWISTHALER 220 mcg twice daily (n=60), 220 mcg once daily in the morning (n=41), 220 mcg once daily in the evening (n=40), 440 mcg once daily in the morning (n=44), 440 once daily in the evening (n=41), 440 mcg twice daily (n=62), 880 mcg once daily (n=59), or at variable doses (n=128) for 52 weeks. The safety profile of Asmanex TWISTHALER in the 52-week trials was similar to the findings in the 8- to 12-week clinical trials. In patients previously on inhaled corticosteroids, cataracts were reported in 3 patients (0.9%) treated with Asmanex TWISTHALER, compared to 1 patient (1.7%) treated with the active comparator medication. Increased ocular pressure at the end of the study was observed in 2 patients, both on Asmanex TWISTHALER 880 mcg once daily in the morning. Oral candidiasis, dysphonia, and dysmenorrhea were seen at a higher frequency with long-term administration than in the 8- to 12-week trials.
Pediatric Patients 4 to 11 Years of Age: In the three 12-week clinical trials in pediatric patients 4 to 11 years of age, patients with asthma were previously maintained on bronchodilators and/or inhaled corticosteroids. The safety results from 1 trial are described in Table 3 for Asmanex TWISTHALER 110 mcg once daily in the evening. The safety results from the other 2 trials showed similar findings.
Overall adverse reactions were reported with approximately the same frequency by patients treated with Asmanex TWISTHALER and those receiving placebo. Table 3 displays the common adverse reactions (≥2% in any patient group receiving Asmanex TWISTHALER) that occurred more frequently in patients 4 to 11 years of age treated with Asmanex TWISTHALER compared with placebo-treated patients.
| (%) of Patients | ||
|---|---|---|
| Asmanex TWISTHALER | ||
| Adverse Reaction | 110 mcg once daily in the evening (n=98) |
Placebo (n=99) |
| Fever | 7 | 5 |
| Allergic Rhinitis | 4 | 3 |
| Abdominal Pain | 6 | 2 |
| Vomiting | 3 | 2 |
| Urinary Tract Infection | 2 | 1 |
| Bruise | 2 | 0 |
| Average Duration of Exposure (Days) | 72 | 68 |
Long-Term Clinical Trials Experience in Children 4 to 11 Years of Age: In a 52-week, active-controlled, long-term safety trial, 152 patients with asthma 4 to 11 years of age were treated with Asmanex TWISTHALER 110 mcg twice daily (n=74) or 220 mcg once daily (n=78). The safety profile for Asmanex TWISTHALER in the 52-week trial was similar to the findings in the 12-week clinical trials.
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of Asmanex TWISTHALER. Because they 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 Warnings and Precautions (5.3) and Contraindications (4.2)]
Respiratory, Thoracic and Mediastinal Disorders: Asthma aggravation, which may include cough, dyspnea, wheezing and bronchospasm.
TopSide Effects by Body System - for Healthcare Professionals
Gastrointestinal
Gastrointestinal side effects have included dyspepsia, nausea, flatulence, gastroenteritis, vomiting, and anorexia.
Respiratory
Respiratory side effects have included oral candidiasis, pharyngitis, sinus congestion, upper respiratory tract infection, dysphonia, epistaxis, nasal irritation, sinusitis and dry throat.
Genitourinary
Genitourinary side effects have included dysmenorrhea and urinary tract infection.
Psychiatric
Psychiatric side effects have included insomnia and depression.
Dermatologic
Dermatologic side effects have included skin lacerations and insect bites.
General
General side effects have included fatigue, flu-like symptoms, accidental injury, pain, infection and post-procedure pain,
Nervous system
Nervous system side effects have included earache and headache.
Musculoskeletal
Musculoskeletal side effects have included back pain, myalgia, arthralgia, abdominal pain and musculoskeletal pain.
Immunologic
Immunologic side effects have included allergic rhinitis
Hypersensitivity
Hypersensitivity side effects have included postmarketing reports of allergic reaction, facial edema hypersensitivity, and throat tightness.
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