What the label lists and what reports show
Bismuth subcitrate and metronidazole and tetracycline side effects
Bismuth subcitrate and metronidazole and tetracycline's FDA label: “Most frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache.” FAERS holds 1,115 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (123 reports).
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Check it at the source: the bismuth subcitrate and metronidazole and tetracycline FDA label on DailyMed (effective June 29, 2026, H2-Pharma, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache.
Table 2: Adverse reactions with an incidence of ≥ 1% from North American trial, [n (%)]
| Preferred Term | OBMT* (n = 147) | OAC** (n = 152) |
|---|---|---|
| Abnormal feces | 23 (15.6%) | 7 (4.6%) |
| Nausea | 12 (8.2%) | 14 (9.2%) |
| Diarrhea | 10 (6.8%) | 20 (13.2%) |
| Abdominal Pain | 7 (4.8%) | 2 (1.3%) |
| Dyspepsia | 4 (2.7%) | 10 (6.6%) |
| Constipation | 2 (1.4%) | 5 (3.3%) |
| Dry Mouth | 2 (1.4%) | 1 (0.7%) |
| Flatulence | 0 | 4 (2.6%) |
| Glossitis | 0 | 2 (1.3%) |
| Asthenia | 5 (3.4%) | 2 (1.3%) |
| Vaginal infection | 4 (2.7%) | 3 (2.0%) |
| Headache | 8 (5.4%) | 8 (5.3%) |
| Dysgeusia | 6 (4.1%) | 18 (11.8%) |
| Dizziness | 4 (2.7%) | 4 (2.6%) |
| Laboratory test abnormal | 3 (2.0%) | 4 (2.6%) |
| Alanine aminotransferase increased | 2 (1.4%) | 0 |
| Aspartate aminotransferase increased | 2 (1.4%) | 0 |
| Urine abnormality | 2 (1.4%) | 0 |
| Rash Maculo-Papular | 2 (1.4%) | 0 |
| Rash | 1 (0.7%) | 3 (2.0%) |
| Pruritus | 0 | 4 (2.6%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma, LLC at 1-833-520-8580 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PYLERA plus omeprazole (OBMT) to eradicate Helicobacter pylori was assessed in an open-label, randomized, active-controlled clinical trial conducted in North America. The duration of treatment was 10 days with 147 patients exposed to PYLERA plus omeprazole (OBMT) and 152 exposed to control, consisting of omeprazole, amoxicillin, and clarithromycin (OAC). The age of the population in the study ranged from 18 to 75 years, with 59% male patients and 59% Caucasian patients. Adverse drug reactions were reported in 58% of patients in the OBMT group and 59% of patients in the OAC group. There were no adverse reactions leading to discontinuation of the study during the clinical trial. Adverse reactions with an incidence of ≥ 5% in OBMT group include abnormal feces, diarrhea, nausea, and headache. …
Source: FDA drug label, NDA050786 (Labs Juvise), as published by H2-Pharma, LLC, effective June 29, 2026 (SPL set 5cdacbf5-67be-42eb-bd54-8acc32ea1abc), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,115 reports list bismuth subcitrate and metronidazole and tetracycline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18 are coded as a death and 411 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Bismuth subcitrate and metronidazole and tetracycline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions