Fosfomycin Side Effects

Some side effects of fosfomycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to fosfomycin: oral powder for reconstitution

Get emergency medical help if you have any of these signs of an allergic reaction while taking fosfomycin: 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.

For Healthcare Professionals

Applies to fosfomycin: oral powder for reconstitution

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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