A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Aerobid Side Effects, and Drug Interactions - Flunisolide
Aerobid Side Effects, and Drug Interactions - Flunisolide
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, 267 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 l-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.
DRUG INTERACTIONS
No information provided.
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