Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 Ciprofoxacin 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 Fosfomycin Tromethamine therapy.
Post-marketing Experience: Serious adverse events from the marketing experience with Fosfomycin Tromethamine 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 Fosfomycin Tromethamine: anaphylaxis and hearing loss.
Laboratory Changes: Significant laboratory changes reported in U.S.
clinical trials of Fosfomycin Tromethamine 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.
WARNINGS Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Fosfomycin Tromethamine, and may range in severity from mild diarrhea to fatal colitis.
Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.
difficile .
difficile produces toxins A and B which contribute to the development of CDAD.
Hypertoxin producing strains of C.
Like all medications, Fosfomycin Tromethamine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: