Fosfomycin Side Effects
Medically reviewed by Drugs.com. Last updated on Feb 15, 2024.
Applies to fosfomycin: oral powder for solution.
Common side effects of fosfomycin
Some side effects of fosfomycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- itching of the vagina or genital area
- pain during sexual intercourse
- thick, white vaginal discharge with no odor or with a mild odor
Less common
- acid or sour stomach
- back pain
- belching
- body aches or pain
- congestion
- dryness or soreness of the throat
- heartburn
- heavy bleeding
- indigestion
- lack or loss of strength
- pain
- painful menstruation
- runny or stuffy nose
- skin rash
- sneezing
- sore throat
- stomach discomfort or upset
- tender, swollen glands in the neck
- trouble with swallowing
- voice changes
- weakness
Rare
- abnormal stools
- absent missed or irregular menstrual periods
- blindness
- blue-yellow color blindness
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased vision
- difficulty with moving
- dry mouth
- excess air or gas in the stomach or intestines
- eye pain
- full feeling
- headache, severe and throbbing
- joint pain
- loss of appetite
- muscle aching or cramping
- muscle pains or stiffness
- nervousness
- passing gas
- sleepiness or unusual drowsiness
- sleeplessness
- stopping of menstrual bleeding
- swollen joints
- swollen, painful, or tender lymph glands in the neck, armpit, or groin
- trouble sleeping
- unable to sleep
- weight loss
Incidence not known
Serious side effects of fosfomycin
Along with its needed effects, fosfomycin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fosfomycin:
Rare
- blood in the urine
- burning while urinating
- cough or hoarseness
- difficult or painful urination
- fever or chills
- lower back or side pain
- painful or difficult urination
Incidence not known
- abdominal or stomach pain or tenderness
- black, tarry stools
- bloating
- chest pain
- clay-colored stools
- constipation
- dark urine
- diarrhea
- difficulty with swallowing
- dizziness
- fast heartbeat
- headache
- hives
- itching
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of appetite
- nausea or vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rash
- severe abdominal or stomach cramps and pain
- shortness of breath
- sores, ulcers, or white spots on the lips or in the mouth
- swollen or painful glands
- tightness in the chest
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting of blood
- watery and severe diarrhea, which may also be bloody
- wheezing
- worsening of asthma
- yellow eyes or skin
For Healthcare Professionals
Applies to fosfomycin: oral granule for reconstitution, oral powder for reconstitution.
Gastrointestinal
- Very common (10% or more): Diarrhea (up to 10.4%)
- Common (1% to 10%): Nausea, abdominal pain, dyspepsia, retching, stomach ache
- Uncommon (0.1% to 1%): Abnormal stools, constipation, dry mouth, flatulence, vomiting
- Frequency not reported: Pseudomembranous colitis
- Postmarketing reports: Toxic megacolon, antibiotic-associated colitis, oral paresthesias (temporary tingling of mouth, tongue, cheek)[Ref]
Nervous system
- Very common (10% or more): Headache (up to 10.3%)
- Common (1% to 10%): Dizziness
- Uncommon (0.1% to 1%): Dysgeusia, paresthesia, migraine, somnolence, vertigo
- Postmarketing reports: Hearing loss, temporary alterations of taste (dysgeusia, hypogeusia)[Ref]
Genitourinary
- Common (1% to 10%): Vaginitis, dysmenorrhea, vulvovaginitis
- Uncommon (0.1% to 1%): Hematuria, dysuria, menstrual disorder[Ref]
Other
- Common (1% to 10%): Pain, asthenia, injection site phlebitis
- Uncommon (0.1% to 1%): Fatigue, infection, ear disorder, fever, influenza syndrome
- Frequency not reported: Facial edema[Ref]
Hypersensitivity
- Very rare (less than 0.01%): Anaphylactic shock
- Postmarketing reports: Anaphylaxis, anaphylactic reactions (including anaphylactic shock), hypersensitivity[Ref]
Respiratory
- Common (1% to 10%): Rhinitis, pharyngitis
- Uncommon (0.1% to 1%): Dyspnea
- Frequency not reported: Asthmatic attack
- Postmarketing reports: Asthma, exacerbation of asthma[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Uncommon (0.1% to 1%): Pruritus, skin disorder, urticaria
- Frequency not reported: Angioedema[Ref]
Angioedema has also been reported during postmarketing experience.[Ref]
Musculoskeletal
- Common (1% to 10%): Back pain
- Uncommon (0.1% to 1%): Myalgia[Ref]
Metabolic
- Uncommon (0.1% to 1%): Anorexia, decreased appetite, hypernatremia and/or hypokalemia, increased alkaline phosphatase[Ref]
Increased alkaline phosphatase was generally transient and not clinically significant.[Ref]
Hematologic
- Uncommon (0.1% to 1%): Lymphadenopathy
- Rare (0.01% to 0.1%): Aplastic anemia, eosinophilia
- Frequency not reported: Agranulocytosis, granulocytopenia, leukopenia, pancytopenia, thrombocytopenia, increased eosinophil count, increased or decreased white blood cell count, increased and decreased platelet count, decreased hematocrit, decreased hemoglobin[Ref]
Increased eosinophil count, increased or decreased white blood cell count, increased and decreased platelet count, decreased hematocrit, and decreased hemoglobin were generally transient and not clinically significant.
Aplastic anemia has also been reported during postmarketing experience.[Ref]
Hepatic
- Uncommon (0.1% to 1%): Increased ALT, increased AST
- Very rare (less than 0.01%): Fatty liver
- Frequency not reported: Increased bilirubin, hepatitis, cholestatic hepatitis, icterus
- Postmarketing reports: Cholestatic jaundice, hepatic necrosis[Ref]
Fatty liver was completely reversible after IV fosfomycin was discontinued.
Increased bilirubin, increased ALT, and increased AST were generally transient and not clinically significant.[Ref]
Cardiovascular
- Uncommon (0.1% to 1%): Tachycardia
- Postmarketing reports: Hypotension[Ref]
Psychiatric
- Uncommon (0.1% to 1%): Insomnia, nervousness
- Frequency not reported: Confusion[Ref]
Ocular
- Very rare (less than 0.01%): Visual impairment
- Frequency not reported: Unilateral optic neuritis[Ref]
References
1. Jardin A (1990) "A general practitioner multicenter study: fosfomycin trometamol single dose versus pipemidic acid multiple dose." Infection, 18(suppl 2, s89-93
2. Naber KG, Thyroff-Friesinger U (1990) "Fosfomycin trometamol versus ofloxacin/co-trimoxazole as single dose therapy of acute uncomplicated urinary tract infection in females: a multicentre study." Infection, 18(suppl 2, s70-6
3. de Jong Z, Pontonnier F, Plante P (1991) "Single-dose fosfomycin trometamol (Monuril) versus multiple-dose norfloxacin: results of a multicenter study in females with uncomplicated lower urinary tract infections." Urol Int, 46, p. 344-8
4. (2001) "Product Information. Monurol (fosfomycin)." Forest Pharmaceuticals
5. Cerner Multum, Inc. "UK Summary of Product Characteristics."
6. Rosales MJ, Vega F (1998) "Anaphylactic shock due to fosfomycin." Allergy, 53, p. 905-7
Frequently asked questions
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Further information
Fosfomycin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.