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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.

BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE: 848 Adverse Event Reports & Safety Profile

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848
Total FAERS Reports
15 (1.8%)
Deaths Reported
304
Hospitalizations
848
As Primary/Secondary Suspect
28
Life-Threatening
44
Disabilities

Active Ingredient: BISMUTH SUBCITRATE POTASSIUM\METRONIDAZOLE\TETRACYCLINE HYDROCHLORIDE ·

First Report: 2013 · Latest Report: 20250819

What Are the Most Common BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE Side Effects?

#1 Most Reported
Nausea
101 reports (11.9%)
#2 Most Reported
Headache
92 reports (10.8%)
#3 Most Reported
Diarrhoea
81 reports (9.6%)

All BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 101 11.9% 0 25
Headache 92 10.9% 0 30
Diarrhoea 81 9.6% 1 23
Dizziness 62 7.3% 1 12
Asthenia 60 7.1% 0 12
Vomiting 59 7.0% 0 23
Faeces discoloured 58 6.8% 0 6
Off label use 56 6.6% 0 14
Pruritus 55 6.5% 0 23
Dyspnoea 42 5.0% 1 13
Vertigo 42 5.0% 1 8
Abdominal pain upper 39 4.6% 0 12
Pyrexia 39 4.6% 1 28
Decreased appetite 37 4.4% 0 7
Abdominal pain 36 4.3% 0 14
Paraesthesia 36 4.3% 0 12
Fatigue 35 4.1% 0 4
Malaise 35 4.1% 2 6
Dysgeusia 32 3.8% 0 2
Anxiety 31 3.7% 0 14

Who Reports BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE Side Effects? Age & Gender Data

Gender: 64.1% female, 35.9% male. Average age: 52.5 years. Most reports from: FR. View detailed demographics →

Is BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 10 1 5
2014 40 0 15
2015 36 1 14
2016 60 2 27
2017 75 0 24
2018 58 0 23
2019 75 0 27
2020 71 0 36
2021 63 0 12
2022 54 1 21
2023 64 1 37
2024 45 9 12
2025 16 0 11

View full timeline →

What Is BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE Used For?

IndicationReports
Helicobacter infection 506
Helicobacter gastritis 130
Product used for unknown indication 105
Gastritis 17
Gastric ulcer helicobacter 12
Helicobacter test positive 12
Peptic ulcer 10
Gastric ulcer 8
Ulcer 7
Gastroduodenal ulcer 5

BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs Alternatives: Which Is Safer?

BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BISMUTH SUBSALICYLATE BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BISMUTH SUBSALICYLATE\METRONIDAZOLE\TETRACYCLINE BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BISOPROLOL BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BISOPROLOL\BISOPROLOL BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BISOPROLOL\HYDROCHLOROTHIAZIDE BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BIVALIRUDIN BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BLEOMYCIN BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BLINATUMOMAB BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs BLONANSERIN BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE vs --BLOOD-COAGULATION FACTOR VIII FUSION PROTEIN WITH IMMUNOGLOBULIN G1 , ,-BIS WITH IMMUNOGLOBULIN G1

Official FDA Label for BISMUTH SUBCITRATE\METRONIDAZOLE\TETRACYCLINE

Official prescribing information from the FDA-approved drug label.