ADVERSE REACTIONS
Two serious adverse reactions reported in patients treated with metronidazole 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 administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur.
The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping. Constipation has also been reported.
The following reactions have also been reported during treatment with metronidazole:
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 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, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. 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.
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 generally 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.
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REPORTS OF SUSPECTED METRONIDAZOLE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Metronidazole. The information is not vetted and should not be considered as verified clinical evidence.
Possible Metronidazole side effects / adverse reactions in 88 year old female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2011-10-03
Patient: 88 year old female
Reactions: Face Oedema
Suspect drug(s):
Kadian
Dosage: sc
Indication: Product Used FOR Unknown Indication
Vancomycin
Dosage: iv
Indication: Product Used FOR Unknown Indication
Metoclopramide
Dosage: sc
Indication: Product Used FOR Unknown Indication
Metronidazole
Dosage: iv
Indication: Product Used FOR Unknown Indication
Ciprofloxacin
Dosage: iv
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Trospium Chloride; Polyethylene Glycol; Simvastatin; Cetirizine HCL; Amitriptyline HCL; Lidocaine; Propylthiouracil
Possible Metronidazole side effects / adverse reactions in 62 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03
Patient: 62 year old female weighing 58.1 kg (127.7 pounds)
Reactions: Malaise, Vomiting, Nausea, Musculoskeletal Stiffness, Pyrexia
Adverse event resulted in: life threatening event
Suspect drug(s):
Metronidazole
Dosage: 500mg
Administration route: Oral
Indication: Haematuria
Start date: 2011-09-25
End date: 2011-09-26
Metronidazole
Dosage: 500mg
Administration route: Oral
Indication: Diverticulitis
Start date: 2011-09-25
End date: 2011-09-26
Possible Metronidazole side effects / adverse reactions in 88 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-04
Patient: 88 year old female
Reactions: Face Oedema
Suspect drug(s):
Metoclopramide
Dosage: subcutaneous
Indication: Product Used FOR Unknown Indication
Metronidazole
Dosage: ntravenous drip
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: subcutaneous
Indication: Product Used FOR Unknown Indication
Vancomycin Hychloride
Dosage: intravenous drip
Indication: Product Used FOR Unknown Indication
Ciprofloxacin
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Amitriptyline HCL; Polyethylene Glycol; Propylthiouracil; Lidocaine; Trospium Chloride; Cetirizine HCL; Simvastatin
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