Fluids and kidneys
Bad vomiting or diarrhea can cause fluid loss. The label points to kidney checks when that happens.
Label brief
Know the common trouble and the serious warnings.
The label sorts the facts into common effects, serious risks, and health history.
The common problem
Nausea leads the list
In the Saxenda weight-loss trials, about 39 in 100 adults on liraglutide felt sick to their stomach, compared with about 14 in 100 on a dummy shot. About 1 in 10 stopped because of side effects.
The label also lists diarrhea, constipation, and vomiting among the common effects.
Trial comparison
39 in 100
liraglutide
14 in 100
dummy shot
Boxed warning
Thyroid tumors in animals; unknown in people
Every label for this drug has an FDA boxed warning. It covers thyroid tumors seen in rats and mice. No one knows whether the drug causes these tumors in people.
The label rules the drug out for anyone with a personal or family history of medullary thyroid cancer, a specific kind of thyroid cancer. It also rules it out for MEN 2, the short name for a rare inherited condition called multiple endocrine neoplasia type 2, and for a past serious allergic reaction to the drug. Ask the doctor whether either condition has occurred in the family.
A boxed warning is the FDA’s strongest label warning. “Unknown in people” does not mean the risk is absent.
Boxed warning
Known in animals.
Unknown in people.
Other label warnings
Serious does not always mean common
The labels warn about gallbladder problems and rare but serious pancreas swelling. They also warn about kidney injury from fluid loss, severe stomach problems, serious allergic reactions, and food entering the lungs during surgery.
Heart rate
The drug can raise the resting heartbeat a little. The label calls for regular checks.
Surgery
The label warns about food entering the lungs during surgery. The surgery team needs to know about use of the drug.
Combinations and pregnancy
The exact product changes the label language
The labels say not to combine this drug with another liraglutide product, such as Xultophy, or with another medicine from the same family. Give the doctor or pharmacist a full medicine list so they can check it.
The Saxenda label tells the person who prescribed it to stop it when a pregnancy is known. Weight loss has no benefit in pregnancy and may harm the baby.
The Victoza diabetes label says it should be used during pregnancy only when the possible benefit justifies the possible risk to the baby. Anyone who is pregnant or planning pregnancy should name the exact product and reason for treatment when talking with the doctor.
Bring the full list
What else is being taken?
What the doctor checks
History, monitoring, and a progress point
For people with type 2 diabetes, the Saxenda label calls for blood-sugar checks. It also calls for heart-rate checks and kidney checks after bad vomiting or diarrhea.
Key topics include thyroid cancer in the family, pancreas and gallbladder history, serious allergies, other drugs, and pregnancy plans.
The Saxenda label tells the person who prescribed it to review an adult’s progress after 16 weeks. If weight loss is less than 4% of the starting weight, the label says more use is unlikely to lead to a meaningful result.
Checks over time
Health history first
Regular checks
Planned progress review
Urgent help
Urgent help has one clear rule
A severe allergic reaction may begin in seconds or minutes, making it an emergency. Call 911.
For personal questions about symptoms or whether this medicine fits, ask a qualified health professional who can examine you.
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