What the label lists and what reports show
Vonoprazan side effects
Vonoprazan's FDA label: “Most common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal distension, abdominal pain, and nausea.” FAERS holds 7,359 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (466 reports).
- No generic listed
Check it at the source: the vonoprazan FDA label on DailyMed (effective July 16, 2026, Phathom Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VOQUEZNA?VOQUEZNA may cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take VOQUEZNA may develop a kidney problem called acute tubulointerstitial nephritis. Call your healthcare provider right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea caused by an infection ( Clostridioides difficile ) in your intestines. Call your healthcare provider right away if you have watery stools, stomach pain, or fever that does not go away. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of another type of medicine that reduces acid in your stomach known as proton pump inhibitors (PPI medicines) for a long period of time (a year or longer). […]
Source: FDA drug label, Phathom Pharmaceuticals Inc., effective July 16, 2026 (SPL set 0cc52ac5-77ec-4d66-a770-762a1a960914), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal distension, abdominal pain, and nausea.
Table 8: Adverse Reactions Reported in at least 2% of patients in any treatment arm. in Adult Patients with H. pylori Infection These trials were not designed to support comparative claims for VOQUEZNA-containing…
| Adverse Reactions | VOQUEZNA and Amoxicillin N=348 % | VOQUEZNA, Amoxicillin, and Clarithromycin N=346 % | Lansoprazole, Amoxicillin, and Clarithromycin N=345 % |
|---|---|---|---|
| Diarrhea | 5 | 4 | 10 |
| Dysgeusia Represents a grouped term and includes related terms. | 1 | 5 | 6 |
| Vulvovaginal candidiasis | 2 | 3 | 1 |
| Abdominal pain | 3 | 2 | 3 |
| Headache | 1 | 3 | 1 |
| Hypertension | 1 | 2 | 1 |
| Nasopharyngitis | 2 | <1 | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Vitamin B12 (Cobalamin) Deficiency [see Warnings and Precautions (5.6) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.7) ] Fundic Gland Polyps [see Warnings and Precautions (5.9) ] Most common adverse reactions in VOQUEZNA-treated patients are: Healing of Erosive Esophagitis (≥2%): gastritis, diarrhea, abdominal distension, abdominal pain, and nausea. ( 6.1 ) Maintenance of Healed Erosive Esophagitis (≥3%): gastritis, abdominal pain, dyspepsia, hypertension, and urinary tract infection. ( 6.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux Disease (≥2%): abdominal pain, constipation, diarrhea, nausea, and urinary tract infection. ( 6.1 ) Treatment of H. pylori Infection (≥2%): diarrhea, dysgeusia, vulvovaginal candidiasis, abdominal pain, headache, hypertension, and nasopharyngitis.
Source: FDA drug label, Phathom Pharmaceuticals Inc., effective July 16, 2026 (SPL set 0cc52ac5-77ec-4d66-a770-762a1a960914), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,359 reports list vonoprazan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,007 are coded as a death and 3,049 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,176, against a median of 166 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vonoprazan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions