Adverse events of metronidazole and amoxicillin: Retrospective analysis of a large data set of five randomized clinical trials

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Retamal-Valdes, Belen ; Tavares, Ana Paula Laranjeira ; Monique, Sarah ; Pereira da Silva, Helio Doyle ; Mestnik, Maria Josefa ; Duarte, Poliana Mendes ; Miranda, Tamires S. ; Borges, Ivan ; Soares, Geisla Mary Silva ; Faveri, Marcelo ; Castro dos Santos, Nidia ; Gracas, Yasmin Teixeira das ; Souto, Maria Luisa Silveira ; Giudicissi, Marcela ; Romito, Giuseppe Alexandre ; Saraiva, Luciana ; Pannuti, Claudio Mendes ; Figueiredo, Luciene C. ; Feres, Magda

• Document type: Journal article
• Source: JOURNAL OF CLINICAL PERIODONTOLOGY; v. 49, n. 11, p. 12-pg., 2022-08-05.

Abstract

Aim To evaluate the frequency of side effects associated with intake of metronidazole (MTZ) + amoxicillin (AMX) in periodontal treatment, and to explore associations between these events and patients' features. Materials and Methods Data of five randomized clinical trials testing MTZ + AMX adjunctive to mechanical therapy were evaluated. Volunteers answered an adverse event questionnaire. Results Information from 656 subjects was assessed. The frequency of side effects in the antibiotic- and placebo-treated groups ranged from 1.0% to 17.7% and 0.9% to 13.7%, respectively. The events more frequently observed in the antibiotic than in the placebo group were diarrhoea and metallic taste (p < .05). Diabetes significantly raised the odds of a patient reporting discomfort (odds ratio [OR] = 2.6), diarrhoea (OR = 4.0), weakness (OR = 6.0) and excessive sleepiness (OR = 2.9). In systemically healthy volunteers, using antibiotics 3 months post-mechanical treatment (healing phase) (OR = 3.0), being a woman (OR = 3.9) and aged <= 49 (OR = 4.5) significantly increased the chances of reporting adverse events. Conclusions The occurrence of side effects during MTZ + AMX treatment ranged from uncommon (1%) to very common (17.7%). The main factors raising the chances of a patient reporting adverse events were diabetes and taking antibiotics in the healing phase, instead of in the active phase of treatment. Patients <= 49 years old and females also tend to report more side effects. (AU)

• FAPESP's process: 09/17677-8 - Clinical and microbiological influence of the dose and duration of systemic antibiotics in the treatment of chronic periodontitis.
• Grantee: Magda Feres Figueiredo
• Support Opportunities: Regular Research Grants
• FAPESP's process: 11/14872-4 - Systemic metronidazole and amoxicillin as adjuncts to scaling and root planing in the treatment of chronic periodontitis in type 2 diabetic subjects: clinical, glycemic and microbiological evaluations
• Grantee: Tamires Szeremeske de Miranda
• Support Opportunities: Scholarships in Brazil - Master
• FAPESP's process: 16/10958-5 - Influence of moment of systemic metronidazole and amoxicillin administration in the treatment of chronic periodontitis
• Grantee: Magda Feres Figueiredo
• Support Opportunities: Regular Research Grants
• FAPESP's process: 13/01072-5 - Systemic metronidazole and amoxicillin as adjuncts to scaling and root planing in the treatment of chronic periodontitis in type 2 diabetic subjects: clinical, glycemic and microbiological evaluations
• Grantee: Poliana Mendes Duarte
• Support Opportunities: Regular Research Grants
• FAPESP's process: 07/56413-0 - Clinical and microbiological effects of amoxicillin and metronidazole systemic association to scaling and root planing in subjects with generalized aggressive periodontitis
• Grantee: Marcelo de Faveri
• Support Opportunities: Regular Research Grants