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
Nasalcrom Side Effects, and Drug Interactions - Cromolyn Sodium
Nasalcrom Side Effects, and Drug Interactions - Cromolyn Sodium
SIDE EFFECTS
Gelatin Capsules
Most of the adverse events reported in mastocytosis
patients have been transient and could represent symptoms of the
disease. The most frequently reported adverse events in mastocytosis
patients who have received oral cromolyn sodium
capsules during clinical
studies were headache
and diarrhea. Each occurred in 4 of the 87 patients. Pruritus, nausea,
and myalgia were each
reported in 3 patients and abdominal
pain, rash,
and irritability in 2 patients each. One report
of malaise was also
recorded.
A generally similar profile
of adverse events has been reported during studies in other clinical
conditions. Additional reports which have been received during the
course of these studies and spontaneous
reports during foreign marketing include: flushing, urticaria/angioedema,
arthralgia, dizziness, fatigue,
paresthesia, taste
perversion, migraine,
psychosis, anxiety, depression,
insomnia, behavior
change, esophagospasm, flatulence, dysphagia, hepatic
function test
abnormal, edema, dyspnea,
polycythemia, neutropenia, dysuria,
hallucinations, skin erythema
and burning, burning mouth and throat,
stiffness and weakness
of the legs, and postprandial lightheadedness and lethargy. These
events are infrequent, the majority representing only a single report,
and in many cases the causal relationship to oral
cromolyn sodium capsules
is uncertain.
Capsules for Inhalation
Clinical experience
with the use of cromolyn sodium
suggests that adverse reactions are rare events. The most common
side effects are associated
with inhalation of
the powder and include
transient cough
(1 in 5 patients) and mild wheezing
(1 in 25 patients). These effects rarely require treatment or discontinuation
of the drug.
Inhalation Solution
Clinical experience
with the use of cromolyn sodium
suggests that adverse reactions are rare events. The following adverse
reactions have been associated with cromolyn sodium
inhalation solution:
cough, nasal congestion,
nausea, sneezing, and wheezing.
Other reactions have been reported in clinical
trials; however, a causal relationship could not be established:
drowsiness, nasal
itching, nose bleed, nose
burning, serum sickness,
and stomachache.
In addition, adverse reactions have been reported with cromolyn
sodium capsules for inhalation. The most common side
effects are associated with inhalation of the powder
and include transient
cough (1 in 5 patients)
and mild wheezing (1
in 25 patients). These effects rarely require treatment or discontinuation
of the drug.
Capsules for Inhalation and Inhalation Solution
Information on the incidence
of adverse reactions to cromolyn sodium has been derived from U.S.
postmarketing surveillance
experience. The following adverse reactions attributed to cromolyn
sodium, based upon recurrence
following readministration, have been reported in less than 1 in
10,000 patients: laryngeal
edema, swollen parotid
gland, angioedema,
bronchospasm, joint swelling
and pain, dizziness,
dysuria and urinary
frequency, nausea, cough, wheezing,
headache, nasal
congestion, rash, urticaria
and lacrimation.
Other adverse reactions have been reported in less than 1 in 100,000
patients, and it is unclear whether these are attributable to the
drug: anaphylaxis, nephrosis, periarteritic vasculitis,
pericarditis, peripheral
neuritis, pulmonary
infiltrates with eosinophilia,
polymyositis, exfoliative dermatitis, hemoptysis,
anemia, myalgia,
hoarseness, photodermatitis
and vertigo.
Capsules for Inhalation
The following adverse effects have been reported in less than 1
in 10,000 patients, and are a consequence
of the Spinhaler delivery
system: inhalation of (capsule) gelatin
particles and inhalation
of mouthpiece or propeller.
Inhalation Aerosol
In controlled clinical
studies of cromolyn sodium
inhaler, the most frequently reported adverse reactions attributed
to cromolyn sodium treatment
were: Throat irritation
or dryness, Bad taste, Cough, Wheeze, Nausea.
The most frequently reported adverse reactions attributed to other
forms of cromolyn sodium
(on the basis of recurrence
following readministration) involve the respiratory
tract and are: bronchospasm
[sometimes severe, associated with a precipitous fall
in pulmonary function
(FEV1)], cough, laryngeal
edema (rare), nasal
congestion (sometimes
severe), pharyngeal irritation, and wheezing.
Adverse reactions which occur infrequently and are associated with
administration of the drug
are: anaphylaxis,
angioedema, dizziness,
dysuria and urinary
frequency, joint swelling
and pain, lacrimation,
nausea and headache,
rash, swollen parotid
gland, urticaria,
pulmonary infiltrates
with eosinophilia, substernal burning, and myopathy.
The following adverse reactions have been reported as rare events
and it is unclear whether they are attributable to the drug: anemia,
exfoliative dermatitis, hemoptysis,
hoarseness, myalgia,
nephrosis, periarteritic vasculitis, pericarditis, peripheral
neuritis, photodermatitis,
sneezing, drowsiness, nasal itching, nasal
bleeding, nasal
burning, serum sickness,
stomach ache, polymyositis,
vertigo, and liver disease.
Nasal Solution
The most frequent adverse reactions occurring in the 430 patients
included in the clinical
trials with cromolyn sodium
nasal solution
were sneezing (1 in 10 patients), nasal
stinging (1 in 20), nasal
burning (1 in 25), and nasal
irritation (1 in
40). Headaches and bad taste
were reported in about 1 in 50 patients. Epistaxis, postnasal
drip, and rash were reported
in less than one percent
of the patients. One patient
in the clinical trials
developed anaphylaxis.
Adverse reactions which have occurred in the use of other cromolyn
sodium formulations for inhalation
include angioedema,
joint pain
and swelling, urticaria, cough, and wheezing. Other reactions reported
rarely are serum sickness, periarteritic vasculitis,
polymyositis, pericarditis,
photodermatitis, exfoliative dermatitis,
peripheral neuritis,
and nephrosis.
DRUG INTERACTIONS
Drug Interaction During Pregnancy
Cromolyn sodium and
isoproterenol were studied following subcutaneous injections in
pregnant mice. Cromolyn
sodium alone in doses
of 60 to 540 mg/kg (38 to 338 times the human
dose) did not cause significant
increases in resorptions or major malformations. Isoproterenol alone
at a dose of 2.7 mg/kg
(90 times the human dose)
increased both resorptions and malformations. The addition
of cromolyn sodium (338
times the human dose)
to isoproterenol (90 times the human
dose) appears to have increased the incidence
of both resorptions and malformations.
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