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
Maxair Side Effects, and Drug Interactions - Pirbuterol
Maxair Side Effects, and Drug Interactions - Pirbuterol
SIDE EFFECTS
The following rates of adverse reactions to pirbuterol are based
on single- and multiple-dose clinical
trials involving 761 patients, 400 of whom received multiple
doses (mean duration
of treatment was 2.5
months and maximum was
19 months).
The following were the adverse reactions reported more frequently
than 1 in 100 patients:
CNS: nervousness
(6.9%), tremor (6.0%),
headache (2.0%), dizziness
(1.2%).
Cardiovascular: palpitations (1.7%), tachycardia
(1.2%).
Respiratory: cough (1.2%).
Gastrointestinal: nausea
(1.7%).
The following adverse reactions occurred less frequently than
1 in 100 patients and there may be a causal relationship with pirbuterol:
CNS: depression,
anxiety, confusion,
insomnia, weakness,
hyperkinesia, syncope.
Cardiovascular: hypotension,
skipped beats, chest pain.
Gastrointestinal: dry mouth,
glossitis, abdominal
pain/cramps, anorexia, diarrhea,
stomatitis, nausea
and vomiting.
Ear, Nose and Throat: smell/taste changes, sore
throat.
Dermatological: rash,
pruritus.
Other: numbness
in extremities, alopecia,
bruising, fatigue, edema, weight
gain, flushing.
Other adverse reactions were reported with a frequency
of less than 1 in 100 patients but a causal relationship between
pirbuterol and the reaction could not be determined: migraine,
productive cough,
wheezing, and dermatitis.
The following rates of adverse reactions during three-month controlled
clinical trials involving 310 patients are noted. The table
does not include mild reactions.
PERCENT OF PATIENTS WITH MODERATE TO
SEVERE SIDE EFFECTS
|
Reaction
|
Pirbuterol
N= 157
|
Metaproterenol
N= 153
|
|
Central Nervous System
|
|
tremors
|
1.3%
|
3.3%
|
|
nervousness
|
4.5%
|
2.6%
|
|
headache
|
1.3%
|
2.0%
|
|
weakness
|
.0%
|
1.3%
|
|
drowsiness
|
.0%
|
0.7%
|
|
dizziness
|
0.6%
|
.0%
|
|
Cardiovascular
|
|
palpitations
|
1.3%
|
1.3%
|
|
tachycardia
|
1.3%
|
2.0%
|
|
Respiratory
|
|
chest pain/ tightness
|
1.3%
|
.0%
|
|
cough
|
.0%
|
0.7%
|
|
Gastrointestinal
|
|
nausea
|
1.3%
|
2.0%
|
|
diarrhea
|
1.3%
|
0.7%
|
|
drymouth
|
1.3%
|
1.3%
|
|
vomiting
|
.0%
|
0.7%
|
|
Dermatological
|
|
skin reaction
|
.0%
|
0.7%
|
|
rash
|
.0%
|
1.3%
|
|
Other
|
|
bruising
|
0.6%
|
.0%
|
|
smell/ taste
change
|
0.6%
|
.0%
|
|
backache
|
.0%
|
0.7%
|
|
fatigue
|
.0%
|
0.7%
|
|
hoarseness
|
.0%
|
0.7%
|
|
nasal congestion
|
.0%
|
0.7%
|
Electrocardiograms
Electrocardiograms, obtained during a randomized, double-blind,
cross-over study in 57 patients, showed no
observations or findings considered clinically significant, or related
to drug administration.
Most electro-cardiographic observations, obtained during a randomized,
double-blind, Cross-over study in 40 patients, were judged not clinically
significant or related
to drug administration. One patient
was noted to have some changes on the one hour postdose electrocardiogram
consisting of ST and T wave
abnormality suggesting
possible inferior ischemia.
This abnormality
was not observed on the predose or the six hours postdose ECG. A
treadmill was subsequently
performed and all the findings were normal.
DRUG INTERACTIONS
Other short-acting beta
adrenergic aerosol
bronchodilators should not be used concomitantly with MAXAIR AUTOHALER
because they may have additive effects.
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