FDA label c1ebaaa3-c4dc-4ec9-91fe-b3985cc3b979

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)

SPL set ID
653be152-7629-41f5-a864-62803f6eadfb
SPL ID
c1ebaaa3-c4dc-4ec9-91fe-b3985cc3b979
Version
9
Effective date
2024-08-01
Source export date
2026-08-17
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-17/1428ecb25c316753060ea7ddb566e8693893fa6e325c185f8717828825c2afb3/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run
20260818T065550Z
Imported at
2026-08-18 08:42:57

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Allergy alert: • Do not use if you are allergic to esomeprazole. • Esomeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. 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 Ask a doctor or pharmacist before use if you are • taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).