FDA label 2e13a795-8686-1b83-e063-6394a90a31ab

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
2e107295-9f1a-9569-e063-6294a90a406c
SPL ID
2e13a795-8686-1b83-e063-6394a90a31ab
Version
2
Effective date
2025-02-13
Source export date
2026-09-28
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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:16:06

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 When using this product ■Do not use in patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption since this drug contains lactose. ■Do not use it for more than 1 month unless the symptoms improve. ■Long-term use should only be done under medical supervision. ■When used in combination with potassium-containing agents, licorice-containing drugs, and diuretics (e.g., furosemide, ethacrynic acid, trichlormethiazide), myopathy is likely to occur, so take it carefully. Ask a doctor before use if you have high blood pressure, edema, sputum, heart or kidney problems, another disease. Stop use and ask a doctor if the following serious side effects occur. These may be signs of a serious condition. ■Gastric aldosteronism (decreased urine, swollen face, hands, feet, eyelids, etc.) ■Myopathy (muscle weakness, cramps, paralysis) ■Interstitial pneumonia (fever, cough, shortness of breath, lung sound abnormalities) ■Liver disorders (elevated liver enzymes, jaundice) ■Skin reactions (rash, hives) ■Digestive issues (loss of appetite, stomach discomfort) 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

Reported adverse events (FAERS/openFDA)#

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