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The two most serious adverse reactions reported in patients treated with metronidazole (metronidazole (metronidazole injection) injection) have been convulsive seizures 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 (metronidazole (metronidazole injection) injection) , 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 intravenous metronidazole (metronidazole (metronidazole injection) injection) :

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

HEMATOPOIETIC: Reversible neutropenia (leukopenia).

DERMATOLOGIC: Erythematous rash and pruritus.

CENTRAL NERVOUS SYSTEM: Headache, dizziness, syncope, ataxia and confusion.

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 (metronidazole (metronidazole injection) injection) and seems to have no clinical significance.

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

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, 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: Convulsive seizures, peripheral neuropathy, dizziness, vertigo, incoordination, ataxia, confusion, irritability, depression, weakness, and insomnia.

HYPERSENSITIVITY: Urticaria, erythematous rash, flushing, nasal congestion, dryness of 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 (metronidazole (metronidazole injection) injection) 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.

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 (metronidazole (metronidazole injection) injection) 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 (metronidazole (metronidazole injection) injection) Injection USP.

Metronidazole (metronidazole (metronidazole injection) injection) has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when Metronidazole (metronidazole (metronidazole injection) injection) Injection USP is prescribed for patients on this type of anticoagulant therapy.

The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole (metronidazole (metronidazole injection) injection) , resulting in reduced plasma levels; impaired clearance of phenytoin has also been reported.

The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole.

Alcoholic beverages should not be consumed during metronidazole (metronidazole (metronidazole injection) injection) therapy because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.

Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole (metronidazole (metronidazole injection) injection) should not be given to patients who have taken disulfiram within the last two weeks.

Drug/Laboratory Test Interactions

Metronidazole (metronidazole (metronidazole injection) injection) may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD →← NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

Last reviewed on RxList: 6/19/2009
This monograph has been modified to include the generic and brand name in many instances.