Monurol Side Effects

Please note - some side effects for Monurol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Monurol - for the Consumer

Monurol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Monurol:

Back pain; diarrhea; dizziness; headache; indigestion; loss of appetite; nausea; painful menstruation; runny nose; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody diarrhea; changes in vision; severe diarrhea; severe stomach cramps or pain; vaginal irritation or discharge; yellowing of skin or eyes.

Monurol Side Effects - for the Professional

Monurol

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:

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.

Although causality has not been established, during postmarketing 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.

Side Effects by Body System

General

In general, fosfomycin is well tolerated with minimal and transient adverse reactions. Adverse effects, if they occur, are usually short-lived due to the fact that fosfomycin is given as a single dose.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (9%), nausea (4.1%), abdominal pain (2.2%), and dyspepsia (1.1%). Abnormal stools, anorexia, constipation, dry mouth, flatulence, vomiting, and toxic megacolon have been reported rarely.

Nervous system

Nervous system side effects have included headache (10%), dizziness (2.3%), asthenia (1.7%); paresthesia, migraine, somnolence, and nervousness.

Genitourinary

Genitourinary side effects have included vaginitis (5.5%), dysmenorrhea (2.6%), dysuria, and menstrual disorder.

Other

Rhinitis and pharyngitis has been reported in less than 5% of patients, although a causal relationship has not been established. Other rare, serious adverse events include angioedema.

Hypersensitivity

Hypersensitivity reactions such as rash have been reported infrequently (less than 2%). One case of anaphylactic shock has been reported.

Ocular

Ocular side effects have included one reported case of unilateral optic neuritis, considered possibly related to fosfomycin therapy.

Hematologic

Hematologic side effects have included rare reports of aplastic anemia. Transient laboratory changes have also been reported in trials: increased eosinophil count, increased or decreased WBC count, increased bilirubin, increased alkaline phosphatase, increased or decreased platelet counts, and decreased hemoglobin. Causality has not been established.

Hepatic

Hepatic side effects have been reported rarely and include cholestatic jaundice and hepatic necrosis. Transient increases in SGPT and SGOT have also been reported, but causality has not been established.

Respiratory

Respiratory side effects have been reported rarely. Exacerbation of asthma has been reported.

Dermatologic

Dermatologic side effects have been reported rarely in clinical trials, but causality has not been established. Rash (1.4%) and skin disorders have been reported.

Musculoskeletal

Musculoskeletal side effects have included reports of myalgia (less than 1%) in clinical trials. Causality has not been established.

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