Vomiting in the US label
Table 1 of the US prescribing information lists reactions that reached 5% on Victoza® and were more frequent than on placebo, in five glycemic control trials in adults. [1] Vomiting is the fifth row. The difference between the two doses is larger here than for nausea: three percentage points separate 1.2 mg and 1.8 mg.
| Group | People in group | Reported vomiting |
|---|---|---|
| Placebo | 661 | 2% |
| Liraglutide 1.2 mg | 645 | 6% |
| Liraglutide 1.8 mg | 1,024 | 9% |
Trial by trial
The Canadian monograph shows each trial on its own and counts events regardless of whether an investigator blamed the medicine. [3] The rows below show how much the figure moves with the trial design. The 52-week LEAD-3 trial, where Victoza® was the only diabetes medicine, recorded the highest rates; the multi-year LEADER cardiovascular trial recorded the lowest. [3]
| Trial and background | Victoza® | Comparison |
|---|---|---|
| LEAD-2, 26 weeks, with metformin [3] | 0.6 mg 5.4%; 1.2 mg 6.7%; 1.8 mg 7.4% | Placebo 0.8%; glimepiride 0.4% |
| LEAD-5, 26 weeks, with metformin and glimepiride [3] | 1.8 mg 6.5% | Placebo 3.5%; insulin glargine 0.4% |
| Trial 1860, 26 weeks, with metformin [3] | 1.2 mg 7.7%; 1.8 mg 9.6% | Sitagliptin 4.1% |
| Trial 1842, 52 weeks, 1.8 mg with metformin [3] | 3.1%; 4.9% when insulin detemir was added | No placebo arm |
| LEAD-3, 52 weeks, Victoza® alone [3] | 1.2 mg 12.4%; 1.8 mg 9.3% | Glimepiride 3.6% |
| LEADER, high cardiovascular risk [3] | 2.1% | Placebo 0.5% |
| EU frequency class [2] | Common (1 in 100 to 1 in 10) | — |
Dose, metformin and age
The dose pattern is not perfectly tidy. The US pool and trial 1860 show more vomiting at 1.8 mg than 1.2 mg, while LEAD-3 shows the reverse. [1][3] A systematic analysis of 32 phase 3 trials of GLP-1 medicines found a trend towards more vomiting at higher doses that did not reach statistical significance, and a clear association between metformin background and vomiting. [4] Most people on Victoza® also take metformin, so this is worth knowing, although it describes averages across trials rather than any individual.
The European product information adds that people over 70 and those with mild or moderate kidney impairment may have more digestive effects on liraglutide. [2] In the trial that led to approval for ages 10 and up, digestive side effects were more frequent with liraglutide than with placebo. [5]
Why the label watches vomiting closely
Section 5.5 of the US label describes acute kidney injury reported after approval, sometimes needing dialysis, and says most cases happened in people whose nausea, vomiting or diarrhea had left them dehydrated. [1] It asks prescribers to monitor kidney function in patients reporting such reactions, especially when starting and increasing the dose. [1] The European text gives the same message and lists dehydration as an uncommon reaction. [2] Canada notes that some of these kidney events occurred in people with no known kidney disease. [3]
Vomiting can matter for other tablets too. The US label says delayed stomach emptying may affect how oral medicines are absorbed and asks for caution, and the European text asks for closer INR checks when liraglutide is started in someone taking warfarin. [1][2] If you vomit soon after taking an important tablet, ask your pharmacist what to do.
Why it might happen
Label-supported: Victoza® slows the emptying of the stomach, which is part of how it lowers blood sugar after meals. [1] The European leaflet says vomiting, like nausea, is more likely at the start of treatment and tends to lessen. [2]
Associated in research, cause not established: the link with metformin background comes from pooled published trials, which cannot separate the two medicines’ effects in one person. [4]
General medicine: MedlinePlus lists the GLP-1 medicines it calls glutides among common causes of vomiting, alongside stomach infections and food poisoning. [6]
When vomiting points somewhere else
Vomiting can be part of a more serious picture, and the Victoza® documents name several. Severe, persistent belly pain that may spread to the back, with or without vomiting, can be pancreatitis. [1] Upper belly pain with fever, yellow skin or eyes or pale stools can be a gallbladder problem. [1] The European leaflet describes bowel obstruction as a severe form of constipation with stomach ache, bloating and vomiting, and rates it rare. [2]
Outside the medicine, MedlinePlus lists infections, food poisoning, migraine, pregnancy, motion sickness and appendicitis, and says diabetes is linked to slow stomach emptying. [6][9] The US label does not recommend Victoza® for people with severe gastroparesis. [1]
Sick days with type 2 diabetes
An illness that makes you vomit can also shift blood sugar. MedlinePlus’s liraglutide page asks you to check with your doctor about what to do if you get sick, develop an infection or fever, because these conditions can affect your blood sugar. [8] The Canadian patient information asks you to tell your healthcare professional before treatment if you have severe vomiting, diarrhea or dehydration. [3] If you also take insulin or a sulfonylurea, the label says your risk of low blood sugar is higher, so a sick-day plan agreed in advance is useful. [1]
What the sources say helps
- Fluids: the US Medication Guide and the EU leaflet both ask you to drink fluids to lower the risk of dehydration, especially early in treatment. [1][2]
- Small, frequent sips: MedlinePlus suggests drinking small amounts of clear liquids often while vomiting. [6]
- Watching for dehydration: MedlinePlus lists thirst, a dry mouth, passing little urine, dark urine and dizziness as warning signs. [7]
- Reporting it: the US label asks prescribers to tell patients to report persistent or extended nausea, vomiting or diarrhea promptly. [1]
- Dose changes: the label leaves any change in dose or restart to your prescriber; do not skip or double doses on your own. [1]
Too much Victoza®
Severe nausea and vomiting are among the effects reported after an overdose. [1] The European summary records overdoses of up to 40 times the maintenance dose, with severe nausea, vomiting, diarrhea and severe low blood sugar, and says patients should be watched for dehydration and have their blood sugar monitored. [2] The Medication Guide directs you to your provider, the Poison Help line or an emergency room if you inject too much. [1]
Victoza® is a registered trademark of Novo Nordisk A/S. PepLabo is not affiliated with or endorsed by Novo Nordisk A/S.
When to get help
The signs and contact information below come from this article’s sourced guidance.
Emergency
- Vomiting blood or material that looks like coffee grounds
Contact: Emergency services (911 or local number)
MedlinePlus [6]
- Severe belly pain that will not go away, with or without vomiting, sometimes felt in the back
Contact: Stop Victoza® and call your provider straight away
Medication Guide [1]
- Confusion, fainting or very little urine after repeated vomiting
Contact: Emergency services
MedlinePlus [7]
- Possible overdose, or vomiting after injecting too much
Contact: Your provider, Poison Help or an emergency room
Medication Guide [1]
Today
At your next appointment
- Occasional vomiting after dose increases that is getting in the way of eating
Contact: Raise it with your prescriber
US label section 17 [1]