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
Monurol Side Effects, and Drug Interactions - Fosfomycin
Monurol Side Effects, and Drug Interactions - Fosfomycin
SIDE EFFECTS
Clinical Trials:
In clinical studies, drug related adverse events which were reported in greater
than 1% of the fosfomycin-treated study population are listed below:
Drug-Related Adverse Events (%) in Fosfomycin and Comparator
Populations
|
Adverse
Events
|
Fosfomycin
N=1233 |
Nitrofurantoin
N=374 |
Trimethoprim /
sulfamethoxazole
N=428 |
Ciprofloxacin
N=445 |
|
Diarrhea
|
9.0 |
6.4 |
2.3 |
3.1 |
|
Vaginitis
|
5.5 |
5.3 |
4.7 |
6.3 |
|
Nausea
|
4.1 |
7.2 |
8.6 |
3.4 |
|
Headache
|
3.9 |
5.9 |
5.4 |
3.4 |
|
Dizziness
|
1.3 |
1.9 |
2.3 |
2.2 |
|
Asthenia
|
1.1 |
0.3 |
0.5 |
0.0 |
|
Dyspepsia
|
1.1 |
2.1 |
0.7 |
1.1 |
In clinical trials, the most frequently reported adverse events occurring in
>1% of the study population regardless of drug relationship, were:
diarrhea 10.4%, headache 10.3%, vaginitis 7.6%, nausea 5.2%, rhinitis 4.5%,
back pain 3.0%, dysmenorrhea 2.6%, pharyngitis 2.5%, dizziness 2.3%, abdominal
pain 2.2%, pain 2.2%, dyspepsia 1.8%, asthenia 1.7%, and rash 1.4%.
The following adverse events occurred in clinical trials at a rate of less
than 1%, regardless of drug relationship:
abnormal stools, anorexia, constipation, dry mouth, dysuria, ear disorder,
fever, flatulence, flu syndrome, hematuria, infection, insomnia, lymphadenopathy,
menstrual disorder, migraine, myalgia, nervousness, paresthesia, pruritus, SGPT
increased, skin disorder, somnolence, and vomiting.
One patient developed unilateral optic neuritis, an event considered possibly
related to MONUROL therapy.
Post-marketing Experience:
Serious adverse events from the marketing experience with MONUROL outside of
the United States have been rarely reported and include:
angioedema, aplastic anemia, asthma (exacerbation), cholestatic jaundice, hepatic
necrosis, and toxic megacolon.
Laboratory Changes:
Significant laboratory changes reported in U.S. clinical trials of MONUROL
without regard to drug relationship include: increased eosinophil count, increased
or decreased WBC count, increased bilirubin, increased SGPT, increased SGOT,
increased alkaline phosphatase, decreased hematocrit, decreased hemoglobin,
increased and decreased platelet count. The changes were generally transient
and were not clinically significant.
DRUG INTERACTIONS
Metoclopramide: When coadministered with MONUROL, metoclopramide,
a drug which increases gastrointestinal motility, lowers the serum concentration
and urinary excretion of fosfomycin. Other drugs that increase gastrointestinal
motility may produce similar effects.
Cimetidine: Cimetidine does not affect the pharmacokinetics
of fosfomycin when coadministered with MONUROL.
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