FDA label 43023cf0-85b2-cbbe-e063-6294a90a76a4

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
43023ce6-c6df-20b6-e063-6294a90ab6ed
SPL ID
43023cf0-85b2-cbbe-e063-6294a90a76a4
Version
1
Effective date
2025-11-07
Source export date
2026-09-28
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:57:21

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 — Read carefully and tell your doctor if any apply to you. Pancreatitis: Cases of pancreatitis have been reported. If you have severe abdominal pain (that may spread to the back), persistent vomiting, or signs of pancreatitis — stop using and contact your healthcare provider immediately. Allergic reaction: Serious allergic reactions have been reported. Stop use and seek emergency care if you have hives, swelling of face/lips/tongue/throat, or trouble breathing. Serious gastrointestinal disease: May cause GI adverse reactions. Not recommended for patients with severe GI disease (not studied). Acute gallbladder disease: Cases (e.g., gallstones) have been reported. If you experience severe right-upper-abdominal pain or jaundice, seek medical evaluation. 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 or breastfeeding: Do not use. Children: Do not use. 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 Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia (indigestion), abdominal pain. If side effects are severe or persistent, contact your healthcare provider. When to stop and call your doctor If you develop severe abdominal pain (possible pancreatitis), severe allergic reaction, jaundice, or other serious symptoms.

Reported adverse events (FAERS/openFDA)#

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