Bismuth, Metronidazole, and Tetracycline
Bismuth, metronidazole, and tetracycline is a three-ingredient antibiotic combination used to eliminate Helicobacter pylori infection in people with active duodenal ulcers or a history of duodenal ulcer disease.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Metronidazole, one of the three ingredients in this combination, has caused cancer in laboratory mice and rats. Tumors were found in the liver, lungs, breast tissue, and lymph system in animal studies. It is not known whether metronidazole causes cancer in humans. Because of this, this medication should be used only when clearly needed for a proven or strongly suspected bacterial infection — not as a precaution or for conditions where antibiotics won't help.
📖 Bismuth, Metronidazole, and Tetracycline: Patient Information Guide
A plain-language walkthrough of Bismuth, Metronidazole, and Tetracycline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Bismuth, metronidazole, and tetracycline is an antibiotic combination approved for one specific purpose: eliminating Helicobacter pylori (H. pylori) bacteria in the stomach.
- Pylera capsules are indicated, used together with omeprazole, to treat H. pylori infection in adults who have an active duodenal ulcer or a history of duodenal ulcer disease within the past 5 years
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride capsules carry the same indication — used with omeprazole to eradicate H. pylori and reduce the risk of duodenal ulcers returning
- Clearing H. pylori has been shown to lower the chance of duodenal ulcers coming back
- This combination should only be used for infections proven or strongly suspected to be caused by bacteria — using it unnecessarily contributes to antibiotic resistance
⚙️How it works▾
This medication combines two antibiotics — metronidazole (a nitroimidazole) and tetracycline hydrochloride (a tetracycline-class antibiotic) — with bismuth subcitrate potassium. The antibiotics target and kill H. pylori bacteria, while bismuth subcitrate potassium adds its own antimicrobial activity directly in the stomach where the infection lives. The three components work together to attack the bacteria from multiple angles.
💊How it's taken▾
The capsules are taken by mouth four times a day — after breakfast, after lunch, after dinner, and at bedtime — for exactly 10 days. Omeprazole is taken twice a day (after the morning and evening meals) at the same time as this regimen. Always swallow capsules whole with a full 8-ounce glass of water.
- Drink extra fluid with the bedtime dose to reduce the risk of throat or esophageal irritation
- Do not take antacids, dairy products, iron supplements, or multivitamins at the same time as the capsules — these can block absorption
- If you miss a dose, pick up where you left off; never double up. Contact your prescriber if you miss more than 4 doses
🤒Side effects — in detail▾
The most commonly reported side effects include:
- Dark or abnormal stools — this is harmless and caused by the bismuth component
- Nausea
- Diarrhea
- Headache
- Abdominal pain
- Altered or metallic taste
- Dizziness
- Fatigue or weakness
Contact your doctor right away if you experience severe skin reactions (blistering, widespread rash, or peeling), signs of nerve problems (numbness, tingling, confusion, or seizures), vision changes, or severe headaches — these are rare but serious and need prompt medical attention.
⚠️Warnings & precautions▾
- Cancer risk in animals: Metronidazole has caused tumors in mice and rats. Whether this applies to humans is unknown. Use only when clearly needed.
- Nerve and brain effects: Metronidazole can rarely cause seizures, encephalopathy (brain dysfunction), and peripheral neuropathy (tingling or numbness). Tetracycline can raise pressure inside the skull. Bismuth has also been linked to neurotoxicity at excessive doses. Report any unusual neurological symptoms immediately.
- Severe skin reactions: Life-threatening skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with metronidazole. Stop the medication and seek emergency care if you develop a spreading blistering rash.
- Pregnancy harm: Tetracycline can permanently stain and damage a developing baby's teeth and bones. This medication is contraindicated in pregnancy.
- Sun sensitivity: Tetracycline can cause an exaggerated sunburn reaction. Avoid direct sunlight and sunlamps during treatment. Stop the medication at the first sign of skin redness from sun exposure.
- Liver impairment: Not recommended in patients with severe liver disease. Those with mild-to-moderate liver problems need closer monitoring.
- Tongue darkening and black stools: Bismuth may temporarily darken the tongue and turn stools black — this is harmless and reversible, but should not be confused with blood in the stool (melena).
🔀What it interacts with▾
This combination interacts with several common medications and substances — tell your doctor and pharmacist about everything you take:
- Alcohol: Must be completely avoided during treatment and for at least 3 days after — mixing metronidazole with alcohol causes a severe reaction including nausea, vomiting, flushing, and cramps
- Disulfiram: Do not use if you've taken disulfiram in the past two weeks — serious psychotic reactions can occur
- Warfarin and blood thinners: Both metronidazole and tetracycline can increase bleeding risk; clotting tests need close monitoring
- Lithium: Metronidazole raises lithium levels in the blood, which can lead to lithium toxicity; monitoring of lithium and creatinine levels is required
- Oral contraceptives (birth control pills): Tetracycline can make them less effective; use a backup or alternative method during treatment
- Busulfan (chemotherapy): Metronidazole raises busulfan blood levels, increasing toxicity risk; avoid unless absolutely necessary
- Antacids, dairy, iron, multivitamins: These block tetracycline absorption — do not take at the same time as the capsules
- CYP450-interacting drugs (e.g., cimetidine, phenytoin, phenobarbital): Can raise or lower metronidazole levels; phenytoin levels should also be monitored
- Drugs that prolong the QT interval (affect heart rhythm): Metronidazole can also affect QT interval; use with caution alongside other such drugs
- Isotretinoin (acne medication): Should be avoided with tetracycline because both can raise pressure inside the skull
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Do not take — tetracycline harms fetal bone and tooth development, and metronidazole has been linked to certain birth defects
- Breastfeeding: Pump and discard breast milk for the entire duration of treatment and for 2 days after it ends; do not feed expressed milk collected during this time to your baby
- Children under 8: Do not use — tetracycline can permanently discolor developing teeth and affect enamel formation
- Severe kidney disease: Contraindicated — tetracycline accumulates to dangerous levels and can cause serious metabolic problems
- Cockayne syndrome: Contraindicated — metronidazole can cause fatal liver failure in people with this rare condition
- Recent disulfiram use: Do not take within two weeks of stopping disulfiram
- Severe liver disease: Not recommended — metronidazole builds up in the blood when the liver cannot process it properly
- History of blood disorders: Use with caution; white blood cell counts should be checked before and after treatment
- Older adults: May need closer monitoring, especially if kidney function is reduced, as bismuth is cleared through the kidneys
- Known allergy: Do not take if you are allergic to bismuth, metronidazole or other nitroimidazoles, or any tetracycline antibiotic
🚑If you take too much▾
If you or someone else takes too much, call a poison control center, your doctor, or go to an emergency room right away. Metronidazole overdose can cause nausea, vomiting, loss of coordination (ataxia), and — with very high repeated doses — seizures and nerve damage. There is no specific antidote for metronidazole overdose; treatment is supportive. For tetracycline overdose, the medication should be stopped and supportive care provided.
🔬Pharmacokinetics — how your body processes it▾
Each of the three components is absorbed and cleared differently. Metronidazole is well absorbed by mouth, reaches peak blood levels within 1 to 2 hours, and is mainly cleared through the urine over about 8 hours. Tetracycline hydrochloride is absorbed in the stomach and upper small intestine (60–90%), though food, milk, and certain minerals significantly reduce this absorption. It is distributed widely throughout the body, passes into the bile, and is excreted in urine and feces. Bismuth is highly bound to proteins in the blood and clears very slowly — its elimination half-life is about 5 days, and it continues to be excreted in urine for weeks after treatment ends, suggesting it accumulates in body tissues. When all three ingredients are taken together in the combination capsule, the body absorbs each component similarly to taking them separately.
📦How to store it▾
Store at controlled room temperature .
📄 Written from Bismuth, Metronidazole, and Tetracycline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Bismuth, Metronidazole, and Tetracycline
148 supplements and herbal products have documented interactions with Bismuth, Metronidazole, and Tetracycline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 128
- Minor · 14
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Bismuth, Metronidazole, and Tetracycline has been associated with lower levels of 11 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 10
- Moderate · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Bismuth, Metronidazole, and Tetracycline — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication doing — why do I need three drugs at once? ▾
Can I drink alcohol while taking this? ▾
My stools have turned black and my tongue looks dark — should I be worried? ▾
I'm on the pill — do I need to worry about this medication affecting my birth control? ▾
What side effects are normal versus when should I actually call my doctor? ▾
Is it safe to take antacids if my stomach is upset while I'm on this? ▾
Is Bismuth, Metronidazole, and Tetracycline available over the counter? ▾
When was Bismuth, Metronidazole, and Tetracycline first available? ▾
Who makes Bismuth, Metronidazole, and Tetracycline? ▾
💬 Answers drafted from Bismuth, Metronidazole, and Tetracycline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Bismuth, Metronidazole, and Tetracycline comes
Bismuth, Metronidazole, and Tetracycline is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Pylera capsules are used, in combination with omeprazole, to eradicate H. pylori in adults with active duodenal ulcer or a history of duodenal ulcer within the past 5 years
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride capsules are used, in combination with omeprazole, to eradicate H. pylori in adults with duodenal ulcer disease
- Eradicating H. pylori with these capsules has been shown to reduce the risk of duodenal ulcer recurrence
- Pylera: swallow capsules whole with a full 8-ounce glass of water — do not chew or crush
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride capsules: take four times daily — after each meal and at bedtime — for 10 days, alongside omeprazole twice daily after the morning and evening meals
- Pylera: drink plenty of fluid with the bedtime dose to reduce the risk of throat or esophageal irritation from tetracycline
- If a dose is missed, continue your normal schedule; do not double up — and call your prescriber if you miss more than 4 doses total
📊 Bismuth, Metronidazole, and Tetracycline across the U.S. market
How Bismuth, Metronidazole, and Tetracycline appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Bismuth, Metronidazole, and Tetracycline is used
A general measure of how commonly Bismuth, Metronidazole, and Tetracycline is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Bismuth, Metronidazole, and Tetracycline is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Bismuth, Metronidazole, and Tetracycline prescribed? Of the 1,594 medications we measure, Bismuth, Metronidazole, and Tetracycline ranks #857 by Medicaid prescriptions — more than 46% of them.
Utilization by Bismuth, Metronidazole, and Tetracycline product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1294619
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bismuth, Metronidazole, and Tetracycline, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 9 listed Bismuth, Metronidazole, and Tetracycline NDCs with Medicaid activity.
🔍 Compare Bismuth, Metronidazole, and Tetracycline products
A representative set of FDA-listed product records for Bismuth, Metronidazole, and Tetracycline — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 140; 125; 125 mg/1; mg/1; mg | Oral | Allergan, Inc. × 2 listings | NDA | View NDC → |
| BISMUTH SUBCITRATE POTASSIUM 140 mg/1; METRONIDAZOLE 125 mg/1; TETRACYCLINE HYDROCHLORIDE 125 mg | Oral | H2-Pharma, LLC × 3 listings | NDA | View NDC → |
| BISMUTH SUBCITRATE POTASSIUM 140 mg/1; METRONIDAZOLE 125 mg/1; TETRACYCLINE HYDROCHLORIDE 125 mg | Oral | H2-Pharma, LLC | NDA AUTHORIZED GENERIC | View NDC → |
| 140; 125; 125 mg/1; mg/1; mg | Oral | H2-Pharma, LLC × 2 listings | NDA | View NDC → |
| BISMUTH SUBCITRATE POTASSIUM 140 mg/1; METRONIDAZOLE 125 mg/1; TETRACYCLINE HYDROCHLORIDE 125 mg | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 140; 125; 125 mg/1; mg/1; mg | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| BISMUTH SUBCITRATE POTASSIUM 140 mg/1; METRONIDAZOLE 125 mg/1; TETRACYCLINE HYDROCHLORIDE 125 mg | Oral | Par Health USA, LLC | ANDA | View NDC → |
| 140; 125; 125 mg/1; mg/1; mg | Oral | Par Pharmaceutical, Inc. | ANDA | View NDC → |
Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Bismuth, Metronidazole, and Tetracycline NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bismuth, Metronidazole, and Tetracycline — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bismuth, Metronidazole, and Tetracycline in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Bismuth, Metronidazole, and Tetracycline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Bismuth, Metronidazole, and Tetracycline is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Bismuth, Metronidazole, and Tetracycline belongs to the Tetracycline-class Antimicrobial class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 5 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. H2-Pharma, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.