Voquezna Triple Pak Side Effects

Generic name: amoxicillin / clarithromycin / vonoprazan

Medically reviewed by Drugs.com. Last updated on Nov 9, 2023.

Note: This document contains side effect information about amoxicillin / clarithromycin / vonoprazan. Some dosage forms listed on this page may not apply to the brand name Voquezna Triple Pak.

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

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:

Less common

Acid or sour stomach
anxiety
belching
black, tarry stools
bladder pain
blistering, crusting, irritation, itching, or reddening of the skin
bloated
bloody or cloudy urine
blurred vision
body aches or pain
change in taste
chest pain or tightness
chills
cold flu-like symptoms
constipation
cracked, dry, or scaly skin
cough or hoarseness
diarrhea
difficult, burning, or painful urination
discouragement
dizziness
dry mouth
ear congestion
excess air or gas in stomach or intestines
eye pain
fainting
fast, pounding, or irregular heartbeat or pulse
feeling sad or empty
fever
frequent urge to urinate
full feeling
general feeling of illness
greatly decreased frequency of urination or amount of urine
headache
heartburn
indigestion
irregular heartbeat recurrent
irritability
itching of the vagina or genitals
lack of appetite
loss of interest or pleasure
loss of taste
loss of voice
lower back or side pain
nausea
nervousness
pain or swelling in the arms or legs without any injury
pale skin
passing gas
pounding in the ears
slow or fast heartbeat
sneezing
sore throat
sores, ulcers, or white spots in the mouth or on the lips
stomach bloating, burning, cramping, discomfort, upset, or pain
stuffy or runny nose
swelling around the eyes
swelling of feet or lower legs
swelling or inflammation of the mouth
thick, white vaginal discharge with mild or no odor
trouble breathing
trouble concentrating
trouble sleeping
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
weight loss
white or brownish vaginal discharge

Rare

Muscle aches

Incidence not known

Black, hairy tongue
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
cold sweats
coma
confusion
confusion about identity, place, and time
coughing up blood
dark urine
diarrhea, watery and severe, which may also be bloody
difficulty swallowing
feeling of unreality
increased menstrual flow or vaginal bleeding
increased thirst
joint or muscle pain
light-colored stools
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
muscle cramps, spasms, pains, or stiffness
nightmares
nosebleeds
pains in stomach, side, or abdomen, possibly radiating to the back
palpitations
paralysis
pinpoint red spots on skin
prolonged bleeding from cuts
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
red irritated eyes
red skin lesions, often with a purple center
seizures
sense of detachment from self or body
shakiness
slurred speech
stiff neck or back
swollen glands
tooth discoloration
unpleasant breath odor
vomiting of blood
yellow eyes or skin

For Healthcare Professionals

Applies to amoxicillin / clarithromycin / vonoprazan: oral kit.

General

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

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]

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]

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

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

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]

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]