Esomeprazole

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Esomeprazole
Generic name
ESOMEPRAZOLE MAGNESIUM
Manufacturer
VALU MERCHANDISERS COMPANY
Product type
HUMAN OTC DRUG
SPL set ID
ab83bbdd-2c8e-46bd-b39e-69199e004be4
SPL ID
2bac9451-0cc9-49a4-ad53-5ca6648a64ce
Version
2
Effective date
2023-11-03
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:40:11
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings Allergy alert: ▪ Do not use if you are allergic to esomeprazole ▪ Esomeprazole may cause severe skin reactions. Symptoms include: ▪ skin reddening ▪ blisters ▪ rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use if you have: • trouble or pain swallowing food, vomiting with blood, or bloody or black stools • heartburn with lightheadedness, sweating or dizziness • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness • frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain

warnings table

<table width="100%"><col width="31%"/><col width="31%"/><col width="31%"/><tbody><tr styleCode="Toprule"><td valign="top"><list listType="unordered"><item><caption>&#x25AA;</caption>skin reddening</item></list></td><td valign="top"><list listType="unordered"><item><caption>&#x25AA;</caption>blisters</item></list></td><td valign="top"><list listType="unordered"><item><caption>&#x25AA;</caption>rash</item></list></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.