Adverse events reported in controlled clinical trials and long-term open studies in 514 patients treated with AEROBID (flunisolide) are described below. Of those patients, 463 were treated for 3 months or longer, 407 for 6 months or longer, 287 for 1 year or longer and 122 for 2 years or longer.
Musculoskeletal reactions were reported in 35% of steroid-dependent patients in whom the dose of oral steroid was being tapered. This is a well-known effect of steroid withdrawal.
Incidence 10% or greater:
Gastrointestinal: diarrhea (10%), nausea and/or vomiting (25%), upset stomach (10%)
General: flu (10%)
Mouth and Throat: sore throat (20%)
Nervous System: headache (25%)
Respiratory: cold symptoms (15%), nasal congestion (15%), upper respiratory infection (25%)
Special Senses: unpleasant taste (10%)
Gastrointestinal: abdominal pain, heartburn
General: chest pain, decreased appetite, edema, fever
Mouth and Throat: Candida infection
Nervous System: dizziness, irritability, nervousness, shakiness
Reproductive: menstrual disturbances
Respiratory: chest congestion, cough* hoarseness, rhinitis, runny nose, sinus congestion sinus drainage, sinus infection, sinusitis, sneezing, sputum, wheezing*
Skin: eczema, itching (pruritus), rash
Special Senses: ear infection, loss of smell or taste
General: chills, increased appetite and weight gain, malaise, peripheral edema, sweating, weakness
Cardiovascular: hypertension, tachycardia
Gastrointestinal: constipation, dyspepsia, gas
Hemic/Lymph: capillary fragility, enlarged lymph nodes
Mouth and Throat: dry throat, glossitis, mouth irritation, pharyngitis, phlegm, throat irritation
Nervous System: anxiety, depression, faintness, fatigue, hyperactivity, hypoactivity insomnia, moodiness, numbness, vertigo
Respiratory: bronchitis, chest tightness* dyspnea, epistaxis, head stuffiness, laryngitis, nasal irritation, pleurisy, pneumonia, sinus discomfort
Skin: acne, hives or urticaria
Special Senses: blurred vision, earache, eye discomfort, eye infection
Incidence less than 1%, judged by investigators as possibly or probably drug related:
abdominal fullness, shortness of breath.
*The incidences as shown of cough, wheezing, and chest tightness were judged by investigators to be possibly or probably drug related. In placebo-controlled trials, the overall incidences of these adverse events (regardless of investigators'judgement of drug relationship) were similar for drug and placebo-treated groups. They may be related to the vehicle or delivery system.