Prescription medicine

Bismuth subcitrate and metronidazole and tetracycline Brand names: Pylera

Bismuth subcitrate and metronidazole and tetracycline (Pylera) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $2.40 per bismuth-metronidazole-tetracycline 140-125-125 mg capsule in the October 7, 2026 NADAC survey.

Generic listed
Boxed warning

Check it at the source: the bismuth subcitrate and metronidazole and tetracycline FDA label on DailyMed (effective June 29, 2026, H2-Pharma, LLC); the NDA 50786 record on Drugs@FDA; every bismuth subcitrate and metronidazole and tetracycline label on DailyMed.

Highlights of the record

FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

POTENTIAL FOR CARCINOGENICITY.

Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions (5.1) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans ( 5.1 ).

Used for

From the label: indications and usage
PYLERA 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.

Forms and strengths

140 mg / 125 mg / 125 mg

Capsule.

On the market

Earliest approval on file: September 28, 2006 Pylera, Labs Juvise; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 2 first March 6, 2023; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC): 3 of which 2 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $2.40 per capsule Bismuth-metronidazole-tetracycline 140-125-125 mg capsule
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 1,115 through July 30, 2026

What is bismuth subcitrate and metronidazole and tetracycline used for?

From the label: indications and usage
PYLERA 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. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]

Conditions named in the indications of bismuth subcitrate and metronidazole and tetracycline's FDA labels, with every medicine labeled for each:

Acid reflux and ulcers

From other bismuth subcitrate and metronidazole and tetracycline labels
Acid reflux and ulcers: Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease PYLERA in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease …

FDA pharmacologic class: Bismuth, Nitroimidazole Antimicrobial and Tetracycline-class Antimicrobial.

Source: FDA drug label (PYLERA), 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

Is there a generic for bismuth subcitrate and metronidazole and tetracycline (Pylera)?

The FDA approved the first generic bismuth subcitrate and metronidazole and tetracycline on March 6, 2023. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists bismuth subcitrate and metronidazole and tetracycline from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

2006 earliest approval on file
2023 first generic approved

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for bismuth subcitrate and metronidazole and tetracycline (Pylera)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.40 per Bismuth-metronidazole-tetracycline 140-125-125 mg capsule, down 34% from $3.65 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Bismuth-metronidazole-tetracycline 140-125-125 mg capsule (generic)
Pylera 140-125-125 mg capsule (brand)

$5.13

$2.38

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Bismuth-metronidazole-tetracycline 140-125-125 mg capsule	Generic	$2.40 per capsule	$72.08	-34%
Pylera 140-125-125 mg capsule	Brand	$2.43 per capsule	$72.87	n/a

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What does the bismuth subcitrate and metronidazole and tetracycline label say about other medicines?

The bismuth subcitrate and metronidazole and tetracycline label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Busulfan	drug interactions	Decreased absorption of PYLERA; do not take concomitantly. ( 7.6 ) Busulfan: Increased busulfan serum concentrations; avoid concomitant use, monitor for busulfan toxicity. ( 7.7 ) CYP inducers and CYP inhibitors:
Cimetidine	drug interactions	Inhibitors of CYP450 liver enzymes The simultaneous administration of PYLERA and drugs that inhibit microsomal liver enzymes, such as cimetidine, may result in a prolonged half-life and decreased plasma clearance of metronidazole.
Disulfiram	contraindications	CONTRAINDICATIONS Disulfiram usage within the last two weeks. ( 4.1 , 7.1 ) Alcoholic beverage consumption for at least three days during or after therapy. ( 4.2 , 7.2 ) Patients with Cockayne syndrome. ( 4.3 , 6.3 ) Severe renal impairment. ( 4.4 ) Women who are pregnant. …
Isotretinoin	warnings and precautions	Concomitant use of isotretinoin should be avoided because isotretinoin is also known to cause IH.
Lithium	drug interactions	Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. ( 5.14 , 7.5 ) Antacids, Multivitamins or Dairy Products:
Phenobarbital	drug interactions	Inducers of CYP450 liver enzymes The simultaneous administration of PYLERA and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole.
Phenytoin	drug interactions	Inducers of CYP450 liver enzymes The simultaneous administration of PYLERA and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole.
Sodium bicarbonate	drug interactions	The absorption of PYLERA may be reduced if administered with antacids containing aluminium, calcium, or magnesium; preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products due to the interaction between these products and tetracycline.
Warfarin	drug interactions	Anticoagulants PYLERA may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants.

Check bismuth subcitrate and metronidazole and tetracycline against other medicines

What do FAERS reports show for bismuth subcitrate and metronidazole and tetracycline?

The FDA Adverse Event Reporting System holds 1,115 reports that list bismuth subcitrate and metronidazole and tetracycline among the medicines taken, through July 30, 2026, 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.

Reports received each year

The most reported reactions

Nausea (named in the label)123
Headache (named in the label)111
Diarrhoea (named in the label)100
Dizziness (named in the label)80
Faeces Discoloured80
Asthenia (named in the label)76
Vomiting (named in the label)73
Off Label Use (a use or a product term, not a reaction)66

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as bismuth subcitrate and metronidazole and tetracycline?

21 other medicines are given the same way (oral) and in the same FDA class as bismuth subcitrate and metronidazole and tetracycline or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Calcium carbonate	Acid reflux and ulcers	none listed	$0.0315 per tablet 750 mg tablet chewable	No current entry
Omeprazole	Acid reflux and ulcers	121 labelers	$0.0295 per capsule 20 mg capsule	A presentation being discontinued
Famotidine	Acid reflux and ulcers	144 labelers	$0.0289 per tablet 20 mg tablet	No current entry
Esomeprazole	Acid reflux and ulcers	117 labelers	$0.145 per capsule 20 mg capsule	No current entry
Pantoprazole	Acid reflux and ulcers	52 labelers	$0.0358 per tablet 40 mg tablet	No current entry
Lansoprazole	Acid reflux and ulcers	59 labelers	$0.106 per capsule 30 mg capsule	No current entry
Sucralfate	Acid reflux and ulcers	43 labelers	$0.173 per tablet 1 g tablet	No current entry
Metoclopramide	Acid reflux and ulcers	28 labelers	$0.0439 per tablet 10 mg tablet	No current entry

Every medicine labeled for the same conditions as bismuth subcitrate and metronidazole and tetracycline

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to bismuth subcitrate and metronidazole and tetracycline: 21 medicines for the same use
Other nitroimidazole antimicrobials: the pharmacologic class, with prices and generics
Bismuth subcitrate and metronidazole and tetracycline side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other