May 4, 2016
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Flagyl Injection

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Flagyl Injection




Flagyl Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/11/2015

Flagyl, Flagyl ER and Flagyl Injection (metronidazole) are all almost identical antimicrobial drugs that differ mainly in design for use; oral (Flagyl,) oral extended release (Flagyl ER), or intravenous (Flagyl injection) are used to treat bacterial vaginosis (mainly Flagyl ER), trichomonas, amebiasis and anaerobic bacterial infections. Flagyl is available as a generic termed metronidazole. Common side effects for Flagyl, Flagyl ER and Flagyl Injection include nausea, abdominal cramps, stomach upset, vomiting, diarrhea, constipation, headache, weight loss (anorexia), dizziness, or a metallic taste in the mouth. Uncomfortable side effects that may become serious are fevers, pain with urination, mouth sores, tingling or pricking sensations that may become permanent, brain disease, and seizures.

Flagyl is supplied in 250 and 500 mg strength tablets, Flagyl ER is available in 750 mg strength tablets, and Flagyl Injection in 500 mg strength in a buffered 100 ml vial. Dosage is quite variable and dependent upon the severity of disease and other considerations made by the treating physician. Most of the serious side effects may occur with any of these three preparations of Flagyl. Flagyl may cause liver enzyme levels to increase; lithium and creatinine levels should be checked to avoid lithium toxicity or renal compromise. Alcohol may increase the side effects of Flagyl. Patients on disulfiram should not take Flagyl until they have had a two week interval without taking disulfiram, especially alcoholic patients, to avoid psychotic reactions. Treatment in pregnant women (during first 3 months is not advised) or women who are breastfeeding should only be done if the benefits outweigh the potential problems; Flagyl levels approach serum levels in breast milk. Except for use in amebiasis, studies in pediatric patients are not available; Flagyl ER has no pediatric studies.

Our Flagyl, Flagyl ER and Flagyl Injection Side Effects Drug Centers provide a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Flagyl Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions reported in patients treated with metronidazole injection have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged oral administration of metronidazole, patients should be observed carefully if neurologic symptoms occur and a prompt evaluation made of the benefit/risk ratio of the continuation of therapy.

The following reactions have also been reported during treatment with Metronidazole Injection, USP RTU.

Gastrointestinal: Nausea, vomiting, abdominal discomfort, diarrhea and an unpleasant metallic taste.

Hematopoietic: Reversible neutropenia (leukopenia).

Dermatologic: Erythematous rash and pruritus.

Central Nervous System: Encephalopathy, aseptic meningitis, optic neuropathy, headache, dizziness, syncope, ataxia, confusion and dysarthria.

Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, flushing, nasal congestion, dryness of the mouth (or vagina or vulva) and fever.

Local Reactions: Thrombophlebitis after intravenous infusion. This reaction can be minimized or avoided by avoiding prolonged use of indwelling intravenous catheters.

Other: Fever. Instances of a darkened urine have also been reported, and this manifestation has been the subject of a special investigation. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.

The following adverse reactions have been reported during treatment with oral metronidazole:

Gastrointestinal: Nausea, sometimes accompanied by headache, anorexia and occasionally vomiting; diarrhea, epigastric distress, abdominal cramping and constipation.

Mouth: A sharp, unpleasant metallic taste is not unusual. Furry tongue, glossitis and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during effective therapy.

Hematopoietic: Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.

Cardiovascular: Flattening of the T-wave may be seen in electrocardiographic tracings.

Central Nervous System: Encephalopathy, aseptic meningitis, convulsive seizures, optic neuropathy, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness and insomnia.

Hypersensitivity: Urticaria, erythematous rash, Stevens-Johnson Syndrome, flushing, nasal congestion, dryness of the mouth (or vagina or vulva) and fever.

Renal: Dysuria, cystitis, polyuria, incontinence, a sense of pelvic pressure and darkened urine.

Other: Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis and fleeting joint pains sometimes resembling “serum sickness.” If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing or headache. A modification of the taste of alcoholic beverages has also been reported. Rare cases of pancreatitis, which abated on withdrawal of the drug, have been reported.

Crohn's disease patients are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn's disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn's disease is not an approved indication for Metronidazole Injection, USP RTU.

Read the entire FDA prescribing information for Flagyl Injection (Metronidazole Injection)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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