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What the label lists and what reports show

Rabeprazole side effects

Rabeprazole's FDA label: “Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ).” FAERS holds 38,147 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 chronic kidney disease (4,975 reports).

  • Generic listed

Check it at the source: the rabeprazole FDA label on DailyMed (effective January 27, 2026, Waylis Therapeutics LLC); 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 ACIPHEX?

ACIPHEX can cause serious side effects, including: See " What is the most important information I should know about ACIPHEX? " Interaction with warfarin. Taking warfarin with a PPI medicine may lead to an increased risk of bleeding and death. If you take warfarin, your doctor may check your blood to see if you have an increased risk of bleeding. […]

Source: FDA drug label, Waylis Therapeutics LLC, effective January 27, 2026 (SPL set 1eb38279-0237-4967-be7a-c53a826c1138), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ).

From the label: adverse reactions, continued

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.3) ] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions (5.4) ] Bone Fracture [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.8) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.9) ] Fundic Gland Polyps [see Warnings and Precautions (5.11) ] Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ). Most common adverse reactions in adolescents (≥2%) are headache, diarrhea, nausea, vomiting, and abdominal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC at 1-844-944-0912 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The data described below reflect exposure to ACIPHEX delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. …

Source: FDA drug label, Waylis Therapeutics LLC, effective January 27, 2026 (SPL set 1eb38279-0237-4967-be7a-c53a826c1138), via openFDA; the full label on DailyMed

What do FAERS reports show?

38,147 reports list rabeprazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,481 are coded as a death and 13,139 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 2018 (6,767, against a median of 1,935 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 9 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

  • Chronic Kidney Disease4,975
  • Renal Failure3,535
  • Acute Kidney Injury2,843
  • Drug Ineffective (a use or a product term, not a reaction)2,674
  • Nausea (named in the label)2,520
  • Off Label Use (a use or a product term, not a reaction)2,063
  • Pain2,037
  • Headache (named in the label)2,004
  • Diarrhoea (named in the label)1,938
  • Fatigue1,910
  • Dyspnoea1,903
  • Arthralgia (named in the label)1,755
  • Dizziness (named in the label)1,541
  • Death (an outcome recorded in the report)1,497
  • Malaise1,459
  • Pneumonia (named in the label)1,413
  • Fall1,344
  • End Stage Renal Disease1,336
  • Vomiting (named in the label)1,283
  • Cough1,220
  • Asthenia1,183
  • Weight Decreased1,179
  • Tubulointerstitial Nephritis (named in the label)1,175
  • Rash (named in the label)1,097
  • Pain In Extremity1,076

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Rabeprazole: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions