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Monurol

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Monurol

Monurol

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 Fosfo-mycin
N=1233
Nitro-furantoin
N=374
Trimeth-oprim/ sulfameth-oxazole
N=428
Cipro-floxacin
N=455
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%, dysmenorrheal 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.

Although causality has not been established, during post marketing surveillance, the following events have occurred in patients prescribed Monurol: anaphylaxis and hearing loss.

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.

Read the Monurol (fosfomycin) Side Effects Center for a complete guide to possible side effects

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.

Read the Monurol Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 5/31/2011
This monograph has been modified to include the generic and brand name in many instances.

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Monurol - User Reviews

Monurol User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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