Fosfomycin Side Effects

Brand Names: Monurol

Please note - some side effects for Fosfomycin 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 Fosfomycin - for the Consumer

Fosfomycin

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 Fosfomycin:

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.

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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