Monurol Side Effects

Generic name: fosfomycin

Medically reviewed by Drugs.com. Last updated on Aug 16, 2024.

Note: This document provides detailed information about Monurol Side Effects associated with fosfomycin. Some dosage forms listed on this page may not apply specifically to the brand name Monurol.

Applies to fosfomycin: oral powder for solution.

Common side effects of Monurol

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 side effects

• 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 side effects

• 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 side effects

• 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

• hearing loss

Serious side effects of Monurol

Along with its needed effects, fosfomycin (the active ingredient contained in Monurol) 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 side effects

• 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 adverse events

• 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]

Frequently asked questions

• What antibiotics are used to treat UTI?
• How long do antibiotics take to work?

Further information

Monurol 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer