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Monurol (Fosfomycin Tromethamine) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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=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.



REPORTS OF SUSPECTED MONUROL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Monurol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Monurol side effects / adverse reactions in 34 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-01-05

Patient: 34 year old female

Reactions: Atrial Tachycardia

Adverse event resulted in: hospitalization

Suspect drug(s):
Monurol



Possible Monurol side effects / adverse reactions in 60 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-11

Patient: 60 year old female

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Suspect drug(s):
Ciprofloxacin Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Cystitis
    Start date: 2012-05-12
    End date: 2012-05-15

Lodine
    Dosage: unk
    Administration route: Oral
    Indication: Pain Prophylaxis

Monurol
    Dosage: unk
    Administration route: Oral
    Indication: Cystitis
    Start date: 2012-05-10
    End date: 2012-05-10



See index of all Monurol side effect reports >>

Drug label data at the top of this Page last updated: 2011-02-08

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