Monurol Side Effects

Generic Name: fosfomycin

Note: This page contains side effects data for the generic drug fosfomycin. It is possible that some of the dosage forms included below may not apply to the brand name Monurol.

It is possible that some side effects of Monurol may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to fosfomycin: oral powder for solution

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
  • 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

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
  • Hearing loss

For Healthcare Professionals

Applies to fosfomycin: oral powder for reconstitution

General

In general, fosfomycin (the active ingredient contained in Monurol) 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 (the active ingredient contained in Monurol) 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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