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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

METRONIDAZOLE\SPIRAMYCIN: 78 Adverse Event Reports & Safety Profile

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78
Total FAERS Reports
2 (2.6%)
Deaths Reported
48
Hospitalizations
78
As Primary/Secondary Suspect

First Report: 20110226 · Latest Report: 20241008

What Are the Most Common METRONIDAZOLE\SPIRAMYCIN Side Effects?

#1 Most Reported
Hepatocellular injury
15 reports (19.2%)
#2 Most Reported
Rash maculo-papular
9 reports (11.5%)
#3 Most Reported
Pyrexia
9 reports (11.5%)

All METRONIDAZOLE\SPIRAMYCIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hepatocellular injury 15 19.2% 0 10
Pyrexia 9 11.5% 0 8
Rash maculo-papular 9 11.5% 0 8
Pruritus 8 10.3% 0 7
Systemic lupus erythematosus 7 9.0% 0 7
Vomiting 7 9.0% 0 2
Abdominal pain 6 7.7% 0 1
Conjunctival hyperaemia 6 7.7% 0 6
Eyelid oedema 6 7.7% 0 6
Action tremor 5 6.4% 0 0
Agranulocytosis 5 6.4% 0 4
Amyotrophy 5 6.4% 0 0
Angioedema 5 6.4% 0 4
Asthenia 5 6.4% 0 0
Diarrhoea 5 6.4% 0 1
Generalised oedema 5 6.4% 0 0
Insomnia 5 6.4% 0 0
Skin disorder 5 6.4% 0 0

Who Reports METRONIDAZOLE\SPIRAMYCIN Side Effects? Age & Gender Data

Gender: 64.6% female, 35.4% male. Average age: 50.5 years. Most reports from: FR. View detailed demographics →

Is METRONIDAZOLE\SPIRAMYCIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 1
2013 1 0 1
2014 6 0 4
2015 2 2 0
2016 1 0 0
2017 7 0 7
2018 9 0 3
2019 20 0 16
2020 11 0 6
2021 2 0 0
2024 6 0 6

View full timeline →

What Is METRONIDAZOLE\SPIRAMYCIN Used For?

IndicationReports
Tooth infection 14
Product used for unknown indication 13
Tooth abscess 8
Dental operation 5
Tooth extraction 5

Official FDA Label for METRONIDAZOLE\SPIRAMYCIN

Official prescribing information from the FDA-approved drug label.