Talicia Side Effects Center

Last updated on RxList: 9/29/2022
Talicia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Talicia?

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a three-drug combination of:

  • a proton pump inhibitor,
  • a penicillin-class antibacterial, and
  • a rifamycin antibacterial indicated for the treatment of Helicobacter pylori infection in adults.

What Are Side Effects of Talicia?

Talicia may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • fever,
  • sore throat,
  • burning eyes,
  • skin pain,
  • red or purple skin rash with blistering and peeling,
  • severe stomach pain,
  • diarrhea that is watery or bloody (even if it occurs months after your last dose),
  • lightheadedness,
  • easy bruising,
  • unusual bleeding,
  • purple or red spots under your skin,
  • eye pain or redness,
  • vision problems,
  • seeing spots,
  • your eyes may be more sensitive to light,
  • chills,
  • sweating,
  • tiredness,
  • body aches,
  • vomiting,
  • chest pain,
  • cough,
  • shortness of breath,
  • urinating more or less than usual,
  • nausea,
  • blood in your urine,
  • confusion,
  • swelling,
  • rapid weight gain,
  • muscle or joint pain,
  • flu symptoms,
  • chest pain, and
  • rash or patchy skin color that worsens in sunlight

Get medical help right away, if you have any of the symptoms listed above.

Side effects of Talicia include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Talicia

The dosage of Talicia is four (4) capsules every 8 hours with food for 14 days.

Talicia In Children

Safety and effectiveness of Talicia in pediatric patients below the age of 18 years with H. pylori infection has not been established.

What Drugs, Substances, or Supplements Interact with Talicia?

Talicia may interact with other medicines such as:

  • voriconazole,
  • St. John's wort,
  • rifampin,
  • ritonavir,
  • fluconazole,
  • posaconazole,
  • itraconazole,
  • clopidogrel,
  • citalopram,
  • cilostazol,
  • phenytoin,
  • diazepam,
  • antiretrovirals,
  • protease inhibitors,
  • probenecid,
  • allopurinol,
  • oral anticoagulants,
  • methotrexate,
  • digoxin,
  • cyclosporine,
  • disulfiram, and
  • hormonal contraceptives

Tell your doctor all medications and supplements you use.

Talicia During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Talicia; it may harm a fetus. Both rifabutin and amoxicillin components of Talicia interact with hormonal contraceptives resulting in lower levels of these contraceptives. Female patients taking hormonal contraceptives should use an additional non-hormonal method of contraception while taking Talicia. Amoxicillin passes into breast milk. Omeprazole may pass into breast milk. It is unknown if rifabutin passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Talicia (omeprazole magnesium, amoxicillin and rifabutin) Delayed-Release Capsules, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Talicia Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
  • a light-headed feeling, like you might pass out;
  • easy bruising, unusual bleeding, purple or red spots under your skin;
  • eye pain or redness, vision problems, seeing spots, your eyes may be more sensitive to light;
  • flu-like symptoms--fever, chills, sweating, tiredness, body aches, vomiting, chest pain, cough, feeling short of breath;
  • kidney problems--urinating more or less than usual, fever, nausea, vomiting, blood in your urine, confusion, swelling, rapid weight gain; or
  • lupus-like symptoms--muscle or joint pain, flu symptoms, chest pain, and a rash or patchy skin color that worsens in sunlight.

Common side effects may include:

  • red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;
  • indigestion, stomach pain, nausea, vomiting, diarrhea;
  • headache;
  • discolored urine;
  • sore throat;
  • rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Fungal Skin Infections: Types, Symptoms, and Treatments See Slideshow
Talicia Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Clostridioides difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
  • Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
  • Rash in Patients with Mononucleosis [see WARNINGS AND PRECAUTIONS]
  • Uveitis [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience With TALICIA

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 TALICIA was assessed in adult patients who were screened and found to be positive for H. pylori infection in one active-controlled (Study 1) and one placebo-controlled (Study 2) clinical trial. Patients received TALICIA, amoxicillin and omeprazole, or placebo every eight hours for 14 consecutive days taken with food. A total of 305 patients received TALICIA in Studies 1 and 2, 227 patients received amoxicillin and omeprazole (as omeprazole magnesium) in Study 1, and 41 patients received placebo in Study 2. These patients had a mean age of 46.4 years (range 18 to 70 years); 62.3% were female, 80.3% were white with 64.2% Hispanic or Latino.

Adverse Reactions Leading To Discontinuation

Treatment discontinuation due to an adverse reaction occurred in 1% (4/305) of patients receiving TALICIA, <1% (1/227) of patients receiving amoxicillin and omeprazole, and 2% (1/41) of patients receiving placebo. Adverse reactions leading to discontinuation of TALICIA were nausea and vomiting, nausea, nasal congestion, and nasopharyngitis, in one patient each.

Most Common Adverse Reactions

Selected adverse reactions occurring in ≥1% of patients receiving TALICIA in Study 1 and 2 are described in Table 1.

Table 1: Selected Adverse Reactions Occurring in 1% or Greater of Patients Receiving TALICIA in Studies 1 and 2

Adverse Reaction Study 1 Study 2
TALICIA
(N=228)
n (%)
Amoxicillin and Omeprazole
(N=227)
n (%)
TALICIA
(N=77)
n (%)
Placebo
(N=41)
n (%)
Diarrhea 23 (10.1) 18 (7.9) 11 (14.3) 4 (9.8)
Headachea 17 (7.5) 16 (7.0) 12 (15.6) 4 (9.8)
Nausea 11 (4.8) 12 (5.3) 3 (3.9) 1 (2.4)
Abdominal painb 8 (3.5) 11 (4.8) 3 (3.9) 2 (4.9)
Chromaturiac 0 0 10 (13.0) 1 (2.4)
Rashd 6 (2.6) 2 (0.9) 4 (5.2) 0
Dyspepsiae 5 (2.2) 3 (1.3) 1 (1.3) 0
Vomiting 5 (2.2) 5 (2.2) 1 (1.3) 2 (4.9)
Oropharyngeal pain 2 (0.9) 2 (0.9) 3 (3.9) 0
Vulvovaginal candidiasisf 5 (2.2) 5 (2.2) 0 0
a Headache includes: headache and migraine.
b Abdominal pain includes: abdominal pain, abdominal pain upper, and abdominal pain lower.
c Riboflavin was administered in Study 1 to prevent unintentional unblinding and may have contributed to under-reporting of chromaturia.
d Rash includes: rash, rash maculo-papular, rash morbilliform, and urticaria.
e Dyspepsia includes: dyspepsia and epigastric discomfort.
f Vulvovaginal candidiasis includes: vulvovaginal candidiasis, vulvovaginal mycotic infection, fungal infection, and vaginal discharge
+ vulvovaginal burning sensation + vulvovaginal pruritus.

Other Important Adverse Reactions From The Labeling Of The Individual Components Of TALICIA

Additional adverse reactions that occurred in 1% or greater of patients treated with omeprazole or rifabutin alone in clinical trials were as follows:

Omeprazole

Flatulence, acid regurgitation, upper respiratory infection, constipation, dizziness, asthenia, back pain, and cough.

Rifabutin

Flatulence, asthenia, chest pain, fever, pain, leucopenia, anemia, anorexia, eructation, myalgia, insomnia, and taste perversion.

The following selected adverse reactions occurred in less than 1% of patients treated with rifabutin alone: flu-like syndrome, hepatitis, hemolysis, arthralgia, myositis, dyspnea, skin discoloration, thrombocytopenia, pancytopenia, and jaundice.

Post-Marketing Experience With Components Of TALICIA

Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Omeprazole

Cardiovascular: angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: gynecomastia

Gastrointestinal: pancreatitis including fatal pancreatitis, anorexia, irritable colon, fecal discoloration, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis, fundic gland polyps, gastroduodenal carcinoids in patients with Zollinger-Ellison syndrome on long-term treatment as a manifestation of the underlying condition associated with such tumors

Hepatic: fatal hepatic failure or necrosis, hepatic encephalopathy, hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice

Metabolism and Nutritional disorders: hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain

Musculoskeletal: muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture.

Nervous System/Psychiatric: depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, dream abnormalities, tremors, paresthesia, vertigo

Respiratory: epistaxis

Skin and subcutaneous tissue disorders: Severe cutaneous adverse reactions (SCAR) such as SJS, TEN, and AGEP, photosensitivity, urticaria, pruritus, petechiae, purpura, alopecia, dry skin, hyperhidrosis

Special Senses: tinnitus, taste perversion

Ocular: optic atrophy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

Hematologic: Agranulocytosis, hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis

Amoxicillin

Gastrointestinal: black hairy tongue

Liver: hepatic dysfunction, cholestatic jaundice, cholestasis, acute cytolytic hepatitis

Renal: crystalluria [see OVERDOSE]

Hemic and Lymphatic Systems: anemia, hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis

Central Nervous System: hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness

Skin and subcutaneous tissue disorders: SCAR, such as SJS, TEN, and AGEP.

Rifabutin

Blood and lymphatic system disorders: agranulocytosis, lymphopenia

Skin and subcutaneous tissue disorders: SCAR, such as SJS, TEN, DRESS, and AGEP.

DRUG INTERACTIONS

Interactions With Other Drugs And Diagnostics

Drug interaction studies with TALICIA have not been conducted. The drug interaction information described here is based on the prescribing information of individual TALICIA components: omeprazole, amoxicillin, and rifabutin.

Rifabutin is a substrate and inducer of cytochrome P450 (CYP) 3A enzymes. Omeprazole is a substrate and an inhibitor of CYP2C19, and a substrate of CYP3A4. Co-administration of TALICIA and other drugs that are substrates, inhibitors, or inducers of these enzymes may alter concentrations of rifabutin/omeprazole or other co-administered drugs [See Table 2 below see CLINICAL PHARMACOLOGY].

Omeprazole magnesium is a PPI. Refer to the prescribing information of the drugs used concomitantly with TALICIA for further information on their interactions with PPIs.

Table 2: Interactions with TALICIA When Co-Administered with Other Drugs and Diagnostics

CYP2C19 or CYP3A4 Inducers
Clinical Impact Decreased exposure of omeprazole when used concomitantly with strong inducers.
Prevention or Management St. John’s Wort, rifampin: Avoid concomitant use with TALICIA [see WARNINGS AND PRECAUTIONS].
Ritonavir-containing products: See prescribing information for specific drugs.
CYP2C19 or CYP3A4 Inhibitors
Clinical Impact Increased blood levels of omeprazole and rifabutin.
Prevention or Management Voriconazole: Concomitant use with TALICIA is contraindicated [see CONTRAINDICATIONS]. Fluconazole, posaconazole, and itraconazole: Avoid concomitant use with TALICIA. If coadministration cannot be avoided, monitor patients for rifabutin associated adverse events, and lack of anti-fungal efficacy.
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].
Prevention or Management Clopidogrel: Consider use of alternative anti-platelet therapy [see WARNINGS AND PRECAUTIONS]. Avoid concomitant use with TALICIA.
Antiretrovirals/Protease Inhibitors
Clinical Impact

Antiretrovirals/protease inhibitors may increase rifabutin blood levels.

The effect of PPIs (such as omeprazole in TALICIA) on antiretroviral drugs is variable. The clinical importance and the mechanisms behind 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].
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see CLINICAL PHARMACOLOGY].
There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole.
Prevention or Management Delavirdine: Combination treatment with TALICIA and delavirdine is contraindicated [see CONTRAINDICATIONS]. Rilpivirine-containing products: Concomitant use with TALICIA is contraindicated [see CONTRAINDICATIONS]. Avoid concomitant use of TALICIA with amprenavir, indinavir, lopinavir/ritonavir, saquinavir/ritonavir, ritonavir, tipranavir/ritonavir, fosamprenavir/ritonavir, or nelfinavir [see WARNINGS AND PRECAUTIONS]. Other antiretrovirals: See prescribing information for specific antiretroviral drugs.
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. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Prevention or Management Discontinue allopurinol at the first appearance of skin rash. Assess benefit-risk of continuing TALICIA treatment.
Warfarin, and Other Oral Anticoagulants
Clinical Impact Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral 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.

Prevention or Management Monitor INR and prothrombin time and adjust the dose of warfarin or other oral anticoagulants to maintain the desired level of anticoagulation.
Methotrexate
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 leading to methotrexate toxicities [see WARNINGS AND PRECAUTIONS ].
Prevention or Management Avoid concomitant use of TALICIA in patients receiving high-dose methotrexate.
Digoxin
Clinical Impact Potential for increased digoxin blood levels [see CLINICAL PHARMACOLOGY].
Prevention or Management Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information.
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.
Prevention or Management Mycophenolate mofetil (MMF): Use TALICIA with caution in transplant patients receiving MMF [see CLINICAL PHARMACOLOGY].

See the prescribing information of other drugs dependent on gastric pH for absorption.

Tacrolimus
Clinical Impact Potential for increased tacrolimus blood levels, especially in patients who are intermediate or poor metabolizers of CYP2C19.
Prevention or Management Monitor tacrolimus whole blood levels and adjust dose as per the prescribing information for tacrolimus.
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 Interactions are reported with omeprazole and other drugs metabolized via the CYP450 enzymes.
Oral Contraceptives
Clinical Impact Concomitant use of amoxicillin and rifabutin with hormonal contraceptives may lead to loss of its efficacy due to lower estrogen reabsorption and decreased ethinylestradiol and norethindrone concentrations, respectively [see WARNINGS AND PRECAUTIONS].
Prevention or Management Patients should be advised to use additional or alternative non-hormonal methods of contraception.
Diagnostic Investigations for Neuroendocrine Tumors
Clinical Impact PPI-induced decrease in gastric acidity may lead to increased serum chromogranin A (CgA) levels, which may cause false positive results in diagnostics for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS].
Prevention or Management Assess CgA levels at least 14 days after stopping TALICIA treatment and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Urine Glucose Test
Clinical Impact High urine concentrations of ampicillin or amoxicillin may result in false-positive reactions when using glucose tests based on the Benedict’s copperreduction reaction that determines the amount of reducing substances like glucose in the urine.
Prevention or Management Glucose tests based on enzymatic glucose oxidase reactions should be used.
Interaction with Secretin Stimulation Test
Clinical Impact Hyper-response in gastrin secretion in response to secretin stimulation test may falsely suggest gastrinoma.
Prevention or Management Test should be performed at least 14 days after stopping TALICIA treatment to allow gastrin levels to return to baseline.
False Positive Urine Tests for Tetrahydrocannabinol (THC)
Clinical Impact There have been reports of false positive urine screening tests for THC in patients receiving PPIs.
Prevention or Management An alternative confirmatory method should be considered to verify positive results.
Other Laboratory Tests
Clinical Impact Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriolglucuronide, conjugated estrone, and estradiol has been noted.

Read the entire FDA prescribing information for Talicia (Omeprazole Magnesium, Amoxicillin and Rifabutin Delayed-release Capsules)

© Talicia Patient Information is supplied by Cerner Multum, Inc. and Talicia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors