Vonoprazan Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 3, 2025.

Applies to vonoprazan: oral tablet.

Precautions

It is very 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 take 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, check with your doctor.

Do not use vonoprazan if you are also using medicines containing rilpivirine (Edurant®, Complera®). Using these medicines together may cause unwanted side effects.

This medicine is usually given with amoxicillin (Amoxil®) alone, or with amoxicillin and clarithromycin (Biaxin®) to treat ulcers caused by H. pylori infection. Be sure you understand the risks and proper use of any other medicines your doctor prescribes.

Check with your doctor right away if you have a change in frequency of urination or amount of urine, blood in the urine, fever, joint pain, loss of appetite, nausea, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These could be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.

Diarrhea may occur while taking this medicine alone or together with antibiotics. Check with your doctor immediately if you have stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.

This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you use high doses or use it for one year or more. Call your doctor right away if you have severe bone pain or are unable to walk or sit normally.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. 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.

Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are using it together with digoxin (Lanoxin®) or certain diuretics (water pills). Check with your doctor right away if you have convulsions (seizures), a fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

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.

This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are using this medicine for more than 1 year. Talk to your doctor if you have concerns.

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 or vitamin supplements.

Serious side effects of vonoprazan

Along with its needed effects, 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 vonoprazan:

Other side effects of vonoprazan

Some side effects of vonoprazan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to vonoprazan: oral tablet.

General adverse events

The most common adverse reactions occurring in at least 2% of patients treated with this drug across multiple indications (including use in combination with antibacterial agents) included gastritis, diarrhea, abdominal distension, abdominal pain, nausea, dyspepsia, hypertension, urinary tract infection, dysgeusia, vulvovaginal candidiasis, headache, and nasopharyngitis.

For more information on adverse reactions and laboratory changes associated with antibacterial agents (i.e., amoxicillin or clarithromycin) used in combination with this drug refer to the corresponding prescribing information of those agents.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension
• Frequency not reported: Tachycardia, QT prolongation

Dermatologic

• Frequency not reported: Eczema, rash, urticaria, dermatitis, dry skin
• Postmarketing reports: Drug eruption, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis

Gastrointestinal

• Common (1% to 10%): Gastritis, diarrhea, abdominal distension, abdominal pain, nausea, dyspepsia, dysgeusia
• Frequency not reported: Duodenal polyp, fundic gland polyps, dry mouth, dysphagia, eructation, flatulence, gastric polyps, vomiting, constipation, duodenal ulcer, flatulence, gastric ulcer, gastroesophageal reflux disease, hematochezia, large intestine polyp, rectal polyp, stomatitis, tongue discomfort, anal fungal infection, gastrointestinal viral infection, oral fungal infection, tongue fungal infection

Genitourinary

• Common (1% to 10%): Vulvovaginal candidiasis
• Frequency not reported: Vaginal discharge

Hematologic

• Frequency not reported: Anemia, lymphocytosis, leukocytosis, leukopenia, neutropenia
• Postmarketing reports: Thrombocytopenia

Hepatic

• Frequency not reported: Increased liver function test
• Postmarketing reports: Hepatic injury, hepatic failure, jaundice

Hypersensitivity

• Frequency not reported: Drug hypersensitivity
• Postmarketing reports: Anaphylactic shock

Metabolic

• Frequency not reported: Diabetes mellitus, decreased appetite
• Postmarketing reports: Hypomagnesemia, hypokalemia, hypocalcemia, vitamin B12 deficiency

Musculoskeletal

• Frequency not reported: Bone fracture

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Vertigo, dizziness, syncope, ageusia, tension headache

Ocular

• Frequency not reported: Orbital edema

Other

• Frequency not reported: Asthenia, peripheral edema, fatigue, pyrexia, viral infection
• Postmarketing reports: C. difficile (with concomitant antibacterials)

Psychiatric

• Frequency not reported: Anxiety, depression, insomnia

Renal

• Common (1% to 10%): Urinary tract infection
• Frequency not reported: Tubulointerstitial nephritis, renal hypertrophy

Respiratory

• Common (1% to 10%): Nasopharyngitis
• Frequency not reported: Upper respiratory infection, pneumonia, cough, nasal polyps, oropharyngeal pain

See also:

Further information

Vonoprazan 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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