Prescription medicine
Amoxicillin and omeprazole and rifabutin Brand names: Talicia
Amoxicillin and omeprazole and rifabutin (Talicia) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $4.88 per Talicia DR 10-250-12.5 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the amoxicillin and omeprazole and rifabutin FDA label on DailyMed (effective December 23, 2025, RedHill Biopharma Ltd); the NDA 213004 record on Drugs@FDA; every amoxicillin and omeprazole and rifabutin label on DailyMed.
Highlights of the record
FDA label of December 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageTALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.
Forms and strengths
- 10 mg / 250 mg / 12.5 mg
Delayed-release capsule.
On the market
- Earliest approval on file
- November 1, 2019 Talicia, Talicia Holdings; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 27, 2042 Talicia capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $4.88 per capsule Talicia DR 10-250-12.5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 219 through July 30, 2026
What is amoxicillin and omeprazole and rifabutin used for?
From the label: indications and usageTALICIA is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. ( 1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of TALICIA and other antibacterial drugs, TALICIA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
FDA pharmacologic class: Penicillin-class Antibacterial, Proton Pump Inhibitor and Rifamycin Antimycobacterial.
Source: FDA drug label (Talicia), NDA213004 (Talicia Holdings), as published by RedHill Biopharma Ltd, effective December 23, 2025 (SPL set 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f), via openFDA; the full label on DailyMed
Is there a generic for amoxicillin and omeprazole and rifabutin (Talicia)?
No generic amoxicillin and omeprazole and rifabutin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Talicia capsules, the last expiring on May 27, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amoxicillin and omeprazole and rifabutin (Talicia)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $4.88 per Talicia DR 10-250-12.5 mg capsule, up 3% from $4.76 on October 8, 2025. 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.
- Talicia DR 10-250-12.5 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Talicia DR 10-250-12.5 mg capsule | Brand | $4.88 per capsule | $146.47 | +3% |
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 amoxicillin and omeprazole and rifabutin label say about other medicines?
The amoxicillin and omeprazole and rifabutin label names 34 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 |
|---|---|---|
| Allopurinol | drug interactions | Probenecid Clinical Impact Increased and prolonged blood levels of amoxicillin. Allopurinol Clinical Impact Increase in the incidence of rashes is reported in patients receiving both allopurinol and amoxicillin together compared to patients receiving amoxicillin alone. … |
| Ampicillin | drug interactions | Clinical Impact; High urine concentrations of ampicillin or amoxicillin may result in false-positive reactions when using glucose tests based on the Benedict’s copper reduction reaction that determines the amount of reducing substances like glucose in the urine. |
| Atazanavir | drug interactions | … these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3) ]. … |
| Cilostazol | drug interactions | CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clinical Impact Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma concentrations of its active metabolite (s) [see Clinical Pharmacology (12.3) ]. … |
| Citalopram | drug interactions | CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clinical Impact Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma concentrations of its active metabolite (s) [see Clinical Pharmacology (12.3) ]. … |
| Clarithromycin | warnings and precautions | Due to the possible occurrence of uveitis, patients should be carefully monitored when rifabutin, a component of TALICIA, is given in combination with clarithromycin (or other macrolides) and/or fluconazole and related compounds. |
| Clopidogrel | drug interactions | Prevention or Management; Clopidogrel: Consider use of alternative anti-platelet therapy [ see ]. Avoid concomitant use with TALICIA. |
| Cyclosporine | drug interactions | Drugs Metabolized via the CYP450 Enzymes (e.g., cyclosporine, disulfiram) Clinical Impact Interactions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes. Prevention or Management Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken … |
| Dasatinib | drug interactions | Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact Omeprazole can alter the absorption of other drugs due to its effect of reducing intragastric acidity thereby increasing gastric pH. … |
| Diazepam | drug interactions | CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clinical Impact Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma concentrations of its active metabolite (s) [see Clinical Pharmacology (12.3) ]. … |
| Digoxin | drug interactions | Clinical Impact; Potential for increased digoxin blood levels [see ]. |
| Disulfiram | drug interactions | Drugs Metabolized via the CYP450 Enzymes (e.g., cyclosporine, disulfiram) Clinical Impact Interactions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes. Prevention or Management Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken … |
| Erlotinib | drug interactions | Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact Omeprazole can alter the absorption of other drugs due to its effect of reducing intragastric acidity thereby increasing gastric pH. … |
| Estradiol | drug interactions | Clinical Impact; Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. |
Every other medicine the amoxicillin and omeprazole and rifabutin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Estriol | drug interactions | … women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted. |
| Fluconazole | drug interactions | … use with TALICIA is contraindicated [see Contraindications (4) ]. Fluconazole, posaconazole and itraconazole: Avoid concomitant use with TALICIA. … |
| Fosamprenavir | drug interactions | … lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, or nelfinavir [see Warnings and Precautions (5.7) ]. |
| Itraconazole | drug interactions | … contraindicated [see Contraindications (4) ]. Fluconazole, posaconazole and itraconazole: Avoid concomitant use with TALICIA. … |
| Ketoconazole | drug interactions | Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact Omeprazole can alter the absorption … |
| Lopinavir and ritonavir | drug interactions | Antiretrovirals/Protease Inhibitors Clinical Impact Antiretrovirals/protease inhibitors may increase rifabutin blood levels. … |
| Methotrexate | drug interactions | Clinical Impact; Concomitant use of omeprazole with methotrexate (primarily at high doses) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly … |
| Mycophenolate mofetil | drug interactions | Prevention or Management; Mycophenolate mofetil (MMF): Use TALICIA with caution in transplant patients receiving MMF [see ]. … |
| Nelfinavir | drug interactions | … exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug … |
| Nilotinib | drug interactions | Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact Omeprazole can alter the absorption … |
| Norethindrone | drug interactions | … to lower estrogen reabsorption and decreased ethinylestradiol and norethindrone concentrations, respectively [see ]. |
| Phenytoin | drug interactions | CYP2C19 Substrates (e.g., Clopidogrel, citalopram, cilostazol, phenytoin, diazepam) Clinical Impact Increased plasma concentrations of CYP2C19 substrate drugs or decreased/increased plasma … |
| Posaconazole | drug interactions | … TALICIA is contraindicated [see Contraindications (4) ]. Fluconazole, posaconazole and itraconazole: Avoid concomitant use with TALICIA. … |
| Probenecid | drug interactions | Probenecid Clinical Impact Increased and prolonged blood levels of amoxicillin. Allopurinol Clinical Impact Increase in the incidence of rashes is reported in patients receiving both allopurinol and … |
| Rifampin | drug interactions | Prevention or Management; St. John’s Wort, rifampin: Avoid concomitant use with TALICIA [see ]. Ritonavir-containing products: See prescribing information for specific drugs. |
| Rilpivirine | drug interactions | … always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the … |
| Ritonavir | drug interactions | … Avoid concomitant use of TALICIA with amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, or nelfinavir [see Warnings and … |
| Tacrolimus | drug interactions | Clinical Impact; Potential for increased tacrolimus blood levels, especially in patients who are intermediate or poor metabolizers of CYP2C19. |
| Voriconazole | contraindications | … 4.1 ) Rilpivirine-containing products. ( 4.2 ) Delavirdine. ( 4.3 ) Voriconazole. |
| Warfarin | drug interactions | … anticoagulants and in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. |
Check amoxicillin and omeprazole and rifabutin against other medicines
Source: FDA drug label (Talicia), NDA213004 (Talicia Holdings), as published by RedHill Biopharma Ltd, effective December 23, 2025 (SPL set 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f), via openFDA; the full label on DailyMed
What do FAERS reports show for amoxicillin and omeprazole and rifabutin?
The FDA Adverse Event Reporting System holds 219 reports that list amoxicillin and omeprazole and rifabutin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 10 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other penicillins
- the pharmacologic class, with prices and generics
- Amoxicillin and omeprazole and rifabutin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other