The frequency and duration of side-effects associated with the use of oral metronidazole; A prospective study of VITA trial participants

Abstract

Background The tolerability of metronidazole is often perceived as being poor and in particular as being a cause of gastrointestinal side effects, but the frequency, severity and duration of adverse effects (AE) is not well characterised. This study assessed the frequency and type of metronidazole associated AEs in women treated for bacterial vaginosis. Methods An exploratory study of participants from the lactic acid gel versus metronidazole for treating bacterial vaginosis (VITA) randomised controlled trial. In this sub-study, women aged ≥16 years, diagnosed with bacterial vaginosis and who received oral MTZ (400 mg twice daily, for 7 days) were followed up prospectively over 2 weeks. Baseline demographic and clinical data, and self-reported data on the incidence, time to onset, and duration of AEs were analysed. Results 155 women were included, of whom 64% (99/155) reported at least one metronidazole AE, including 47% (72/155) who reported gastrointestinal symptoms (nausea and/or vomiting [52/155], abdominal pain [31/154] or diarrhoea [31/154]) mostly within 3 days of starting treatment and resolving within 5 days of onset. Treatment discontinuation occurred in 8% (12/148) overall and AEs were given as the reason for discontinuing in only 3% (4/148). Conclusion Overall, metronidazole side effects occurred commonly, but resolved within a few days and had a limited impact on treatment completion.

The Efficacy and Safety of Minocycline‐Containing Quadruple Therapies Against Helicobacter pylori Infection: A Retrospective Cohort Study

“… 23 The highest incidence of adverse events (51.43%) was reported in patients on the MMAB regimen. Metronidazole treatment may cause multiple side effects, including gastrointestinal symptoms (nausea and/or vomiting, abdominal pain, and diarrhea), 13 , 24 which were similar to those induced by minocycline. Accordingly, we speculated that such frequently occurring adverse events might be caused by the combination of minocycline and metronidazole.…”

Effect of Cymbopogon olivieri-based herbal vaginal product on bacterial vaginosis

“…Metronidazole (orally or vaginally) is the first line of therapy 6 . However, its side effects (nausea, vomiting, abdominal pain, or diarrhea) 7 - 9 and traditional use of herbal medicines have encouraged researchers to investigate the effectiveness and safety of herbal medicines. Due to its better cultural acceptability, greater adaptability to the human body, and fewer side effects, herbal therapy is the main treatment method for primary care for about 75% of the world's population, especially in developing and developed countries 10 .…”