Voquezna Triple Pak Side Effects

Generic name: amoxicillin / clarithromycin / vonoprazan

Medically reviewed by Drugs.com. Last updated on Jun 15, 2024.

Note: This document provides detailed information about Voquezna Triple Pak.

Applies to amoxicillin / clarithromycin / vonoprazan: oral capsule, oral tablet Side Effects associated with amoxicillin / clarithromycin / vonoprazan. Some dosage forms listed on this page may not apply specifically to the brand name Voquezna Triple Pak.

Applies to amoxicillin / clarithromycin / vonoprazan: oral capsule, oral tablet.

Precautions

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your condition does not improve, or if it becomes worse, discuss this with your doctor.

Do not use this medicine together rilpivirine (Edurant®) or products containing rilpivirine (eg, Complera®, Odefsey®), dihydroergotamine (Migranal®), ergotamine (Cafergot®), pimozide (Olap®), lomitapide (Juxtapid®), lovastatin (Mevacor®), lurasidone (Latuda®), or simvastatin (Zocor®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney disease or liver disease. Using these medicines together may increase risk for more serious side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Talk with your doctor before using this medicine if you plan to have children. Some men who use this medicine have become infertile (unable to have children).

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, rash, itching, fast heartbeat, trouble breathing or swallowing, or large, hive-like swelling of the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs while you are using this medicine.

Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness. These may be symptoms of serious skin reactions, including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis (AGEP), toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with insulin or oral diabetes medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

This medicine may cause drowsiness, trouble with thinking, or trouble with controlling body movements when used together with midazolam (Versed®), quetiapine (Seroquel®), or triazolam (Halcion®). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may increase the risk of bleeding when used together with a blood thinner (eg, warfarin). Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you Stop taking amoxicillin/clarithromycin/vonoprazan. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Check with your doctor right away if you have pain or tenderness in the fever with or without chills, upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation and torsade de pointes.

This medicine may cause myasthenia gravis (severe muscle weakness). Check with your doctor right away if you have difficulty in breathing, chewing, swallowing, or talking, double vision, drooping eyelids, muscle weakness, or severe tiredness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St John's wort) or vitamin supplements.

Serious side effects of Voquezna Triple Pak

Along with its needed effects, amoxicillin / clarithromycin / vonoprazan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking amoxicillin / clarithromycin / vonoprazan:

For healthcare professionals

Applies to amoxicillin / clarithromycin / vonoprazan: oral kit.

General adverse events

The most common adverse reactions leading to discontinuation of this product were diarrhea and hypertension.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension (includes increased blood pressure)
• Frequency not reported: QT prolongation, tachycardia

Clarithromycin:

• Frequency not reported: QT interval prolongation, arrhythmia
• Postmarketing reports: Ventricular arrhythmia, torsades de pointes, hemorrhage^[Ref]

Dermatologic

• Frequency not reported: Dermatitis, dry skin, rash

Amoxicillin, Clarithromycin, and Vonoprazan:

• Frequency not reported: Severe cutaneous adverse reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis)

Amoxicillin:

• Frequency not reported: Erythematous skin rash
• Postmarketing reports: Mucocutaneous candidiasis, erythematous maculopapular rashes, erythema multiforme, exfoliative dermatitis, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP)

Clarithromycin:

• Postmarketing reports: Angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, DRESS, AGEP, Henoch-Schonlein purpura, acne

Vonoprazan:

• Postmarketing reports: Urticaria, drug eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea, abdominal pain (includes abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain)
• Frequency not reported: Abdominal distension, constipation, dry mouth, duodenal polyp, duodenal ulcer, dyspepsia, flatulence, gastric ulcer, gastroesophageal reflux disease, hematochezia, large intestine polyp, nausea, rectal polyp, stomatitis, tongue discomfort, vomiting, anal fungal infection, gastrointestinal viral infection, oral fungal infection, tongue fungal infection

Amoxicillin:

• Frequency not reported: Clostridioides difficile-associated diarrhea
• Postmarketing reports: Black hairy tongue, hemorrhagic/pseudomembranous colitis, tooth discoloration (brown, yellow, or gray staining)

Clarithromycin:

• Frequency not reported: C difficile-associated diarrhea
• Postmarketing reports: Acute pancreatitis, tongue discoloration, tooth discoloration, pseudomembranous colitis

Acid-Suppressing Therapies:

• Frequency not reported: C difficile-associated diarrhea^[Ref]

Onset of pseudomembranous colitis symptoms has been reported during or after antibacterial treatment.

Most reports of tooth discoloration with amoxicillin occurred in pediatric patients; discoloration was reduced/eliminated with brushing or dental cleaning in most cases.

Tooth discoloration with clarithromycin was usually reversible with professional cleaning after the drug was discontinued.^[Ref]

Genitourinary

• Common (1% to 10%): Vulvovaginal candidiasis (includes urogenital fungal infection, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginal pruritus, genital pruritus, genital fungal infection)
• Frequency not reported: Urinary tract infection, vaginal discharge

Amoxicillin:

• Postmarketing reports: Crystalluria

Clarithromycin:

• Postmarketing reports: Abnormal urine color (associated with hepatic failure)^[Ref]

Hematologic

• Frequency not reported: Anemia, leukocytosis, leukopenia, neutropenia

Clarithromycin:

• Postmarketing reports: Thrombocytopenia, agranulocytosis, prolonged prothrombin time, decreased WBC count, increased INR

Penicillins:

• Postmarketing reports: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, agranulocytosis^[Ref]

Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, and agranulocytosis have been reported during therapy with penicillins; these reactions were usually reversible when therapy was stopped and were believed to be hypersensitivity phenomena.^[Ref]

Hepatic

• Frequency not reported: Abnormal liver function test

Clarithromycin:

• Frequency not reported: Cholestatic hepatitis, jaundice
• Postmarketing reports: Hepatic failure, hepatocellular jaundice, hepatic dysfunction (including increased liver enzymes)

Vonoprazan:

• Postmarketing reports: Hepatic injury, hepatic failure, jaundice^[Ref]

Adverse reactions related to hepatic dysfunction have been reported with clarithromycin.^[Ref]

Hypersensitivity

• Frequency not reported: Drug hypersensitivity

Amoxicillin, Clarithromycin, and Vonoprazan:

• Frequency not reported: Hypersensitivity reactions (e.g., anaphylaxis, anaphylactic shock, rash, erythema multiforme, Henoch-Schonlein purpura)

Amoxicillin:

• Postmarketing reports: Anaphylaxis, serum sickness-like reactions, hypersensitivity vasculitis

Clarithromycin:

• Postmarketing reports: Anaphylactic reactions

Vonoprazan:

• Postmarketing reports: Anaphylactic shock^[Ref]

Metabolic

• Frequency not reported: Decreased appetite

Clarithromycin:

• Postmarketing reports: Hypoglycemia^[Ref]

Hypoglycemia has been reported in patients taking clarithromycin with oral hypoglycemic agents or insulin.^[Ref]

Musculoskeletal

• Frequency not reported: Bone fracture

Clarithromycin:

• Postmarketing reports: Myopathy, rhabdomyolysis^[Ref]

Rhabdomyolysis was reported and in some of the reports, clarithromycin was coadministered with statins, fibrates, colchicine, or allopurinol.^[Ref]

Nervous system

• Common (1% to 10%): Dysgeusia (includes taste disorder), headache
• Frequency not reported: Ageusia, dizziness, tension headache

Amoxicillin:

• Postmarketing reports: Reversible hyperactivity, convulsions, aseptic meningitis

Clarithromycin:

• Frequency not reported: New onset of symptoms of myasthenic syndrome, exacerbation of symptoms of myasthenia gravis
• Postmarketing reports: Parosmia, anosmia, paresthesia, convulsions^[Ref]

Ocular

• Frequency not reported: Orbital edema^[Ref]

Other

• Frequency not reported: Fatigue, pyrexia, viral infection

Clarithromycin:

• Postmarketing reports: Deafness^[Ref]

Deafness was reported primarily in elderly women and was usually reversible.^[Ref]

Psychiatric

• Frequency not reported: Anxiety, depression, insomnia

Amoxicillin:

• Postmarketing reports: Agitation, confusion, behavioral changes

Clarithromycin:

• Postmarketing reports: Abnormal behavior, confusional state, depersonalization, disorientation, hallucination, manic behavior, abnormal dream, psychotic disorder^[Ref]

Abnormal behavior, confusional state, depersonalization, disorientation, hallucination, manic behavior, abnormal dream, and psychotic disorder usually resolved when clarithromycin was discontinued.^[Ref]

Renal

• Frequency not reported: Renal hypertrophy, tubulointerstitial nephritis

Clarithromycin:

• Postmarketing reports: Renal failure^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Nasopharyngitis
• Frequency not reported: Pneumonia, upper respiratory tract infection, cough, nasal polyps, oropharyngeal pain^[Ref]

See also:

Further information

Voquezna Triple Pak side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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