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Amoxicillin / clarithromycin / vonoprazan Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 4, 2023.

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

Serious side effects

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

Rare

Incidence not known

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

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

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]

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]

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

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

Frequency not reported: Decreased appetite

Clarithromycin:

-Postmarketing reports: Hypoglycemia[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

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

Frequency not reported: Fatigue, pyrexia, viral infection

Clarithromycin:

-Postmarketing reports: Deafness[Ref]

Psychiatric

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

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]

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]

References

1. Product Information. Voquezna Triple Pak (amoxicillin / clarithromycin / vonoprazan). Phathom Pharmaceuticals, Inc. 2022;ORIG-1.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.