AEROBID SIDE EFFECTS

SIDE EFFECTS

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%)

Incidence 3-9%

• Cardiovascular: palpitations
• 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

Incidence 1-3%

• 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.