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What is Flagyl?

Flagyl (metronidazole) is an antibiotic. It fights bacteria in your body.

Flagyl is used to treat bacterial infections of the vagina, stomach, skin, joints, and respiratory tract. This medication will not treat a vaginal yeast infection.

Flagyl may also be used for purposes not listed in this medication guide.

Important information about Flagyl

Take Flagyl for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Flagyl will not treat a viral infection such as the common cold or flu. Do not drink alcohol while you are taking Flagyl and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Before taking Flagyl

You should not use Flagyl if you are allergic to metronidazole, or if you are in the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before taking Flagyl, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • a stomach or intestinal disease such as Crohn's disease;

  • a blood cell disorder such as anemia (lack of red blood cells) or leukopenia (lack of white blood cells);

  • epilepsy or other seizure disorder; or

  • nerve disorders.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Flagyl.

Metronidazole can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Flagyl?

Take Flagyl exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take the extended-release metronidazole tablet (Flagyl ER) on an empty stomach, at least 1 hour before or 2 hours after eating a meal. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. Take Flagyl for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Flagyl will not treat a viral infection such as the common cold or flu.

To be sure Flagyl is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Flagyl.

Store Flagyl at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, loss of balance or coordination, numbness and tingling, or seizures (convulsions).

What should I avoid while taking Flagyl?

Do not drink alcohol while you are taking Flagyl and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Flagyl and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Flagyl side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Flagyl: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects while using Flagyl:

  • numbness or tingling in your hands or feet;

  • white patches or sores inside your mouth or on your lips;

  • pain or burning when you urinate;

  • diarrhea that is watery or bloody;

  • vision problems, pain behind your eyes;

  • trouble concentrating, slurred speech, mood or behavior changes, tremors, muscle twitching, seizure (convulsions);

  • fever, chills, muscle pain, confusion, headache, sore throat, neck stiffness, increased sensitivity to light, drowsiness, nausea and vomiting; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Flagyl side effects may include:

  • stomach pain, diarrhea;

  • dizziness, loss of balance;

  • vaginal itching or discharge;

  • dry mouth or unpleasant metallic taste;

  • cough, sneezing, runny or stuffy nose; or

  • swollen or sore tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Flagyl?

Tell your doctor about all other medicines you use, especially:

  • cimetidine (Tagamet);

  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • lithium (Lithobid, Eskalith, others); or

  • disulfiram (Antabuse).

This list is not complete and other drugs may interact with Flagyl. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

For the Consumer

Applies to metronidazole: oral capsule, oral suspension, oral tablet, oral tablet extended release

Along with its needed effects, metronidazole (the active ingredient contained in Flagyl) 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 metronidazole:

More common
  • Agitation
  • back pain
  • blindness
  • blurred vision
  • burning, numbness, tingling, or painful sensations in the hands or feet
  • changes in speech patterns
  • confusion
  • convulsions
  • decreased vision
  • depression
  • dizziness
  • drowsiness
  • eye pain
  • fever
  • hallucinations
  • headache
  • irritability
  • lack of coordination
  • mood or mental changes
  • nausea
  • seizures
  • shakiness and unsteady walk
  • slurred speech
  • stiff neck or back
  • trouble with speaking
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting
  • weakness in the arms, hands, legs, or feet
Less common
  • Black, tarry stools
  • blood in the urine or stools
  • body aches or pain
  • chills
  • clumsiness or unsteadiness
  • difficulty with breathing
  • ear congestion
  • feeling of pelvic pressure
  • frequent or painful urination
  • loss of voice
  • nasal congestion
  • pinpoint red spots on the skin
  • runny nose
  • skin rash, hives, redness, or itching
  • sneezing
  • stomach and back pain (severe)
  • unusual bleeding or bruising
  • vaginal irritation, discharge, or dryness not present before taking the medicine
Rare
  • Bleeding gums
  • bloating
  • chest pain
  • constipation
  • cough
  • dark-colored urine
  • fast heartbeat
  • indigestion
  • loss of appetite
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • burning while urinating
  • continuing diarrhea
  • continuing stomach pain
  • diarrhea
  • feeling of warmth
  • increased volume of pale, dilute urine
  • joint or muscle pain
  • loss of bladder control
  • red irritated eyes
  • red skin lesions, often with a purple center
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin

Some side effects of metronidazole 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
  • Abdominal or stomach cramps
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • heartburn
  • sensation of spinning
  • sleeplessness
  • trouble sleeping
  • unable to sleep
  • weight loss
Less common or rare
  • Change in taste sensation
  • congestion
  • dry mouth
  • pain or tenderness around the eyes and cheekbones
  • stuffy nose
  • tender, swollen glands in the neck
  • trouble with swallowing
  • unpleasant or sharp metallic taste
  • voice changes
Incidence not known
  • Decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • painful sexual intercourse

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Applies to metronidazole: compounding powder, intravenous powder for injection, intravenous solution, oral capsule, oral tablet, oral tablet extended release

General

The most serious side effects reported with metronidazole (the active ingredient contained in Flagyl) have included convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy (primarily characterized by numbness or paresthesia of an extremity). Persistent peripheral neuropathy has been reported with prolonged oral administration of metronidazole.

Nervous system

Headache (18%) and dizziness (4%) were reported in patients using the extended-release tablet formulation. Headaches were considered severe in 10% of these patients.

A rare but serious side effect of metronidazole (the active ingredient contained in Flagyl) was peripheral neuropathy which was thought to be related to dose and duration of therapy. Most cases occurred after doses of 1000 to 2400 mg per day for at least 30 days, or a total dose of 50 grams. Neuropathy was generally located in the lower extremities and presented with numbness, tingling, and paresthesias. Patients should be advised to discontinue metronidazole if they experience these effects. Neuropathy may be persistent despite discontinuation of metronidazole. Seizures associated with metronidazole were rare, but did occur.

Several cases of MRI abnormalities of the dentate nuclei associated with symptoms of ataxia and dysarthria have been reported. The symptoms and dentate nuclei lesions resolved several weeks after discontinuation of metronidazole. These symptoms and metronidazole-induced lesions in the brain stem and cerebellar nuclei have also been described in rat studies.

Very common (10% or more): Headache
Common (1% to 10%): Dizziness
Frequency not reported: Encephalopathy, aseptic meningitis, peripheral neuropathy (characterized mainly by numbness or paresthesia of an extremity), convulsive seizures, vertigo, syncope, incoordination, ataxia, confusion, dysarthria, weakness, reversible abnormalities in the cerebellar dentate nuclei

Gastrointestinal

Very common (10% or more): Nausea
Common (1% to 10%): Taste perversion (metallic taste), abdominal pain, diarrhea, dry mouth
Rare (less than 0.1%): Pseudomembranous colitis, pancreatitis
Frequency not reported: Sharp unpleasant metallic taste, vomiting, abdominal discomfort, epigastric distress, abdominal cramping, constipation, proctitis, coating of the tongue (furry tongue), glossitis, stomatitis, taste of alcoholic beverages modified

Nausea (10%), taste perversion (metallic taste; 9%), abdominal pain (4%), diarrhea (4%), and dry mouth (2%) in patients using the extended-release tablet formulation. Nausea was considered severe in less than 2% of these patients.

Furry tongue, glossitis, and stomatitis may be associated with sudden overgrowth of Candida.

Although metronidazole has been used to treat pseudomembranous colitis, it has rarely also been implicated as a causative agent. These rare cases have been successfully treated with vancomycin.

Genitourinary

Very common (10% or more): Vaginitis
Common (1% to 10%): Genital pruritus, abnormal urine, dysmenorrhea, urinary tract infection
Rare (less than 0.1%): Darkened urine
Frequency not reported: Dysuria, cystitis, polyuria, incontinence, vulvovaginal candidiasis, vaginal itching, dyspareunia, sense of pelvic pressure

Vaginitis (15%), genital pruritus (5%), abnormal urine (3%), dysmenorrhea (3%), and urinary tract infection (2%) were reported in patients using the extended-release tablet formulation.

Instances of darkened urine have been investigated. The pigment responsible has not been positively identified; however, it is most likely a metabolite of metronidazole and appears to have no clinical significance.

Other

Common (1% to 10%): Bacterial infection, influenza-like symptoms, moniliasis
Frequency not reported: Fever, overgrowth of Candida, disulfiram-like reaction (abdominal distress, nausea, vomiting, flushing, hypotension, or headache) with ethanol

Bacterial infection (7%), influenza-like symptoms (6%), and moniliasis (3%) were reported in patients using the extended-release tablet formulation.

A disulfiram-like reaction has been reported in some patients drinking ethanol while taking metronidazole. Patients have experienced abdominal distress, vomiting, flushing, nausea, headache, and hypotension. Patients should be advised to refrain from all forms of ethanol while taking metronidazole and for at least 72 hours after the last dose.

Respiratory

Common (1% to 10%): Upper respiratory tract infection, rhinitis, sinusitis, pharyngitis

Upper respiratory tract infection (4%), rhinitis (4%), sinusitis (3%), and pharyngitis (3%) were reported in patients using the extended-release tablet formulation.

Hypersensitivity

Metronidazole (the active ingredient contained in Flagyl) has rarely been associated with a serum sickness-like reaction which presented as arthralgias, malaise, fever, chills, pruritus, and rash.

Rare (less than 0.1%): Serum sickness-like reaction
Frequency not reported: Hypersensitivity (including urticaria, erythematous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the mouth [or vagina or vulva], fever), fixed drug eruptions, cross-sensitivity to other nitroimidazole derivatives

Hematologic

Rare (less than 0.1%): Reversible thrombocytopenia
Frequency not reported: Reversible neutropenia (leukopenia)

Cardiovascular

Frequency not reported: Flattening of the T-wave in ECG tracings

Dermatologic

Frequency not reported: Erythematous rash, pruritus

Local

Frequency not reported: Thrombophlebitis (after IV infusion)

Thrombophlebitis can be minimized or avoided by avoiding prolonged use of indwelling IV catheters.

Psychiatric

Frequency not reported: Irritability, depression, decreased libido, insomnia, disorientation, agitation, hallucinations

Ocular

Frequency not reported: Optic neuropathy

Metabolic

Frequency not reported: Anorexia

Musculoskeletal

Frequency not reported: Fleeting joint pains (sometimes resembling "serum sickness")

Oncologic

Breast and colon cancer have been reported in Crohn's disease patients treated with high doses of metronidazole (the active ingredient contained in Flagyl) for extended periods of time.

Frequency not reported: Breast cancer, colon cancer