FDA label 42498bee-d407-178b-e063-6394a90a053d

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
42498bee-d406-178b-e063-6394a90a053d
SPL ID
42498bee-d407-178b-e063-6394a90a053d
Version
1
Effective date
2025-10-29
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:05:06

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Pancreatitis: Acute pancreatitis has been reported with GLP-1 receptor agonists. If severe or persistent abdominal pain occurs (with or without vomiting), stop using RETATRUTIDE and contact your healthcare provider immediately. Allergic reactions: Serious hypersensitivity reactions (including anaphylaxis) have been reported. Stop use and seek medical attention if you develop rash, swelling, or difficulty breathing. Severe gastrointestinal disease: RETATRUTIDE has not been studied in patients with severe GI disorders; use is not recommended. Gallbladder disease: Acute gallbladder events, including cholelithiasis, have occurred. Evaluate promptly if gallbladder disease is suspected. Hypoglycemia warning: Do not use RETATRUTIDE if you have a history of recurrent or severe hypoglycemia. RETATRUTIDE may further lower blood glucose levels. Use is contraindicated in individuals with baseline hypoglycemia or conditions predisposing to hypoglycemia. Pregnancy and breastfeeding: Do not use if pregnant or breastfeeding. Pediatric use: Not for use in children. Drug Interactions / Precautions Other antidiabetic medications: Retatrutide lowers blood glucose. Using it with insulin or sulfonylureas may increase the risk of hypoglycemia. Blood glucose should be closely monitored; doses of other antidiabetic drugs may need adjustment. Drugs affecting gastrointestinal motility: Retatrutide may delay gastric emptying. Co-administration with prokinetic agents (e.g., domperidone) or antacids may alter absorption or worsen GI discomfort. Cardiovascular medications: Caution with statins, digoxin, or warfarin. Statins: absorption may be affected; monitor lipid levels. Warfarin: changes in metabolism may alter anticoagulant effects; monitor INR levels. General precautions: Retatrutide should be used only under medical supervision. Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal products. Possible side effects Common: nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, abdominal pain. Stop use and contact a doctor if symptoms become severe or persistent. When to stop and call your doctor Stop using the pen and contact your physician if you experience: • Severe or persistent abdominal pain or vomiting • Symptoms of an allergic reaction • Signs of pancreatitis • Any other unexpected or severe reaction

Reported adverse events (FAERS/openFDA)#

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