This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.
Lansoprazole is a medication, a proton pump inhibitor. According to the FDA-approved label, Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. FAERS contains 175,050 submissions naming this drug from 1997 through 2026; the top three reactions cited are chronic kidney disease, acute kidney injury, and renal failure.
Most-Reported Reactions
Counts of the reactions most often cited in FAERS submissions that named Lansoprazole. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.
Patient Demographics
Patient sex and age across the FAERS submissions that named Lansoprazole. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.
By Sex
By Age Group
Severity Outcomes
Severity flags recorded across the 175,050 FAERS submissions that named Lansoprazole. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.
Submissions Per Quarter
Quarterly count of FAERS submissions that named Lansoprazole. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.
From the FDA-Approved Label
Excerpts from the official FDA-approved prescribing information for Lansoprazole. This is the authoritative source on indications, warnings, and known adverse reactions.
Indications
1 INDICATIONS AND USAGE Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults ( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Maintenance of healed duodenal ulcers in adults ( 1.3 ) Treatment of active benign gastric ulcer in adults ( 1.4 ) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults ( 1.6 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) Maintenance of healing of EE in adults ( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults ( 1.10 ) 1.1 Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1 )]. 1.2 Eradication of H. (continues in label)
Adverse Reactions (from label)
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] Clostridium 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 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.7 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.12 )] Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed LLC at 844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 o r www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely 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...
AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.
