Bismuth Subcitrate

Mechanism-of-action class: Acid-Base Activity.

• Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.ICD-10: K26.9

• Disulfiram usage within the last two weeks. ( 4.1 , 7.1 ) Alcoholic beverage consumption for at least three days during or after therapy.contraindicated

Administer three bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules after the morning and evening meal for 10 days ( Table 1 ). Table 1: Daily Dosing Schedule for Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules Time of dose Number of capsules of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride Number of capsules of omeprazole 20 mg After morning meal 3 1 After lunch 3 0 After evening meal 3 1 At bedtime 3 0 Instruct patients to swallow the bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules whole with a full glass of water (8 ounces). Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride. If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted. Administer three bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 4 times a day (after meals and at bedtime) for 10 days. ( 2 ) Administer bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules with omeprazole 20 mg twice daily (after the morning and evening meals). ( 2 )

Fetal Toxicity: Advise pregnant women of the risk throughout pregnancy for retardation of skeletal development seen in animal studies and permanent discoloration of teeth with tetracycline if used during the second or third trimester. ( 5.2 , 8.1 ) Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature birth. ( 5.3 , 8.1 ) Tooth Enamel discoloration and hypoplasia: permanent discoloration may develop with use during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years). ( 5.4 ) Severe Cutaneous Adverse Reactions: Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with metronidazole. If symptoms or signs of SCARs develop, discontinue bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules immediately and institute appropriate therapy. ( 5.5 ) Central and Peripheral Nervous System Effects: encephalopathy, convulsive seizures, aseptic meningitis and peripheral neuropathy with metronidazole, intracranial hypertension with tetracycline and neurotoxicity with bismuth-containing products. Monitor patients with CNS conditions closely and discontinue promptly if abnormal neurologic signs develop. ( 5.6 ) Photosensitivity: avoid exposure to sun and sun lamps.

Most frequently reported adverse reactions (≥5%): abnormal feces, diarrhea, nausea, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ingenus Pharmaceuticals, LLC at 1-877-748-1970 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 bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 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 bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules 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.

Lactation: A woman should pump and discard human milk for the duration of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules therapy, and for 2 days after therapy ends. ( 8.2 ) Pediatric Use: Tetracycline may cause permanent discoloration of the teeth. Enamel hypoplasia has also been reported. Do not use in children less than 8 years of age. ( 5.4 , 8.4 ) 8.1 Pregnancy Risk Summary Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsules are contraindicated in women who are pregnant because treatment of Helicobacter pylori infection can be delayed in pregnant women, and the use of drugs of the tetracycline class during the second and third trimester pregnancy can also cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development [ see Warnings and Precautions ( 5.2 ) and Data ] . Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals. There are maternal risks with high intravenous doses of tetracycline [ see Clinical Considerations ] . Metronidazole usage in pregnancy has been associated with certain congenital anomalies [ see Data ] . In animals, no fetotoxicity was observed when metronidazole was orally administered to pregnant mice at approximately 5% of the indicated human dose.

In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in Bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride capsules are summarized below: Metronidazole: Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Metronidazole is dialyzable. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day. Treatment of Overdosage There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy. Tetracycline: In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage. Bismuth subcitrate potassium: Symptoms of a bismuth subcitrate potassium overdosage are not known.

• Sep 28, 2006NDANDA050786Labs Juvise
• Mar 6, 2023ANDAANDA205770Ph Health
• Jul 3, 2023ANDAANDA217511Ingenus Pharms Llc

1. 1Nausea12111%
2. 2Headache1089.9%
3. 3Diarrhoea978.9%
4. 4Dizziness777.1%
5. 5Asthenia746.8%
6. 6Vomiting726.6%
7. 7Faeces Discoloured716.5%
8. 8Off Label Use656.0%
9. 9Pruritus605.5%
10. 10Fatigue555.1%
11. 11Dyspnoea545.0%
12. 12Abdominal Pain Upper484.4%
13. 13Pyrexia484.4%
14. 14Abdominal Pain434.0%
15. 15Anxiety434.0%

The 10 most recently updated of 61 ClinicalTrials.gov registrations naming Bismuth Subcitrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer
  Recruiting · Phase 2 · Interventional · 180 enrolled · Sixth Affiliated Hospital, Sun Yat-sen University
  NCT06510010updated 2026-06-10
• Effect of Triple Versus Quadruple Therapy for Treating Helicobacter Pylori Infection
  Enrolling by invitation · Interventional · 66 enrolled · Akil Al Islam
  NCT07010744updated 2026-05-07
• The Efficacy of the 7 Days Tailored Therapy as the 1st Eradication of H. Pylori Infection
  Recruiting · Interventional · 600 enrolled · Seoul National University Bundang Hospital
  NCT02373280updated 2026-04-24
• Tegoprazan- Versus PPI-based H. Pylori Eradication
  Recruiting · Observational · 200 enrolled · Soonchunhyang University Hospital
  NCT06682533updated 2026-04-23
• Efficacies of Susceptibility-guided vs Empiric Therapy for Rescue Treatment of Helicobacter Pylori Infection
  Recruiting · Phase 4 · Interventional · 450 enrolled · National Taiwan University Hospital
  NCT05332444updated 2026-04-15
• Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
  Not yet recruiting · Phase 3 · Interventional · 360 enrolled · VA Office of Research and Development
  NCT07104318updated 2026-04-07
• Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding"
  Completed · Phase 3 · Interventional · 121 enrolled · Beni-Suef University
  NCT07487142updated 2026-03-23
• Eradication of Helicobacter Pylori Subtypes at High Gastric Cancer Risk: a Cluster-randomized Controlled Trial
  Not yet recruiting · Interventional · 4,824 enrolled · Fudan University
  NCT06943794updated 2026-02-25
• Treatment Efficacy of Regimens With and Without Bismuth in Children With Helicobacter Pylori-Associated Peptic Ulcer Disease
  Recruiting · Interventional · 80 enrolled · Can Tho University of Medicine and Pharmacy
  NCT07260006updated 2025-12-02
• Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in a High Clarithromycin and Metronidazole Resistance Area Regarding Patients With Peptic Ulcer and Non Ulcer Dyspepsia
  Not yet recruiting · Phase 4 · Interventional · 150 enrolled · Athens Medical Center
  NCT07146594updated 2025-08-28

Frequently asked questions

How does Bismuth Subcitrate work?

Mechanism-of-action class: Acid-Base Activity.

What is Bismuth Subcitrate used for?

According to FDA labeling, Bismuth Subcitrate carries indications including: Bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride capsule is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline, - a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Bismuth Subcitrate?

Bismuth Subcitrate is classified as Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), Acid-Base Activity, Digestive/GI System Activity Alteration.

What are the brand names for Bismuth Subcitrate?

Bismuth Subcitrate is marketed under brand names including Pylera.

What are the contraindications for Bismuth Subcitrate?

Bismuth Subcitrate labeling lists contraindications including: Disulfiram usage within the last two weeks. ( 4.1 , 7.1 ) Alcoholic beverage consumption for at least three days during or after therapy.. Always consult the full prescribing information and a clinician.