FDA label 42ff036a-fd92-4f60-e063-6294a90a49c8

openFDA label record#

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

SPL set ID
42fefef4-22d3-19ba-e063-6394a90af86e
SPL ID
42ff036a-fd92-4f60-e063-6294a90a49c8
Version
1
Effective date
2025-11-07
Source export date
2026-08-08
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/fb2175520ba436c0a81d623fd2a743c12c69c2188c898ffb9cc87c6b64d4a6cd/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:29:17

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