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Monurol

Last reviewed on RxList: 10/17/2016
Monurol Side Effects Center

Last reviewed on RxList 9/23/2016

Monurol (fosfomycin tromethamine) sachet is an antibiotic used to treat bladder infections. Common side effects of Monurol include:

Tell your doctor if you experience unlikely but serious side effects of Monurol including:

  • vaginal discomfort, or
  • stomach/abdominal pain.

Monurol is usually given in only one dose. The recommended dosage of Monurol for women 18 years of age and older for uncomplicated urinary tract infection (acute cystitis) is one sachet, dissolved in water and taken orally. Monurol may interact with metoclopramide (Reglan). Other drugs may affect Monurol. Tell your doctor about all prescription and over-the-counter medications and supplements you use. During pregnancy, Monurol should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Monurol (fosfomycin tromethamine) sachet Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Monurol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may be more likely to occur, such as:

  • diarrhea, nausea, stomach pain or upset;
  • headache;
  • dizziness;
  • weakness;
  • stuffy nose, sore throat;
  • menstrual pain;
  • back pain; or
  • vaginal itching or discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Monurol (Fosfomycin)

Monurol Professional Information

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 entire FDA prescribing information for Monurol (Fosfomycin)

Related Resources for Monurol

Read the Monurol User Reviews »

© Monurol Patient Information is supplied by Cerner Multum, Inc. and Monurol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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