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Victoza® and nausea

Victoza nausea in US, EU and Canadian data: 18–20% versus 5% on placebo, why it peaks early, the 0.6 mg start and when to call.

Published · Updated · Victoza®: side effects by symptom · Written by the PepLabo editorial team

When to get help
Context and scope

Victoza® is the once-daily liraglutide injection for type 2 diabetes in adults and in children aged 10 and over. Nausea sits at the top of its side-effect table in every regulator’s document. This page lines up the US prescribing information, the European product information and the Canadian monograph, adds what trials of liraglutide show about timing and background medicines, and sets out what helps and when nausea needs a call.

Key takeaways 5
  • Nausea leads the US Table 1 for Victoza®: 18% on 1.2 mg and 20% on 1.8 mg against 5% on placebo. [1]
  • Canada reports that about 13% of people on Victoza® and 2% on comparators felt nauseous in the first two weeks, and that most episodes were mild or moderate and declined. [3]
  • In Europe, 20.7% of people taking liraglutide with metformin reported nausea, against 9.1% with a sulfonylurea. [2]
  • Across all long-term EU trials, nausea was the single most frequent reason for stopping Victoza®, at 2.8%. [2]
  • Generic liraglutide approved in the US as a copy of Victoza® carries the same list of most common side effects, led by nausea. [9]

The US trial pool

Section 6.1 of the Victoza® label pools five glycemic control trials in adults, each comparing liraglutide with placebo. In that pool, 1,673 adults received Victoza® for a mean of 37.3 weeks. They were 58 years old on average, had lived with diabetes for about nine years and started with a mean HbA1c of 8.4%. The label adds that a 52-week trial in patients aged 10 and older was also assessed, and that the type and severity of reactions in those young people were comparable to adults. [1]

These figures describe adults with type 2 diabetes on 1.2 mg or 1.8 mg a day. The label itself notes that trial rates cannot be compared directly with another drug’s trials and may differ from everyday care. [1]

Nausea in the Victoza® adult placebo-controlled pool (US label, section 6.1, Table 1)
GroupPeople in groupReported nausea
Placebo6615%
Liraglutide 1.2 mg64518%
Liraglutide 1.8 mg1,02420%

Europe and Canada fill in the detail

The European summary of product characteristics puts nausea in its very common class, meaning at least 1 in 10 people, and says digestive reactions tend to be more frequent at the start and usually lessen within a few days or weeks. [2] The Canadian monograph prints each trial separately and counts every event reported by at least 1% of people, whatever the investigator thought caused it. [3] That makes the background rate in the comparison arms visible.

Nausea in individual Victoza® trials (Health Canada monograph, section 8.2; EU SmPC section 4.8)
Trial and backgroundVictoza®Comparison
LEAD-2, 26 weeks, with metformin [3]0.6 mg 10.7%; 1.2 mg 16.3%; 1.8 mg 18.6%Placebo 4.1%; glimepiride 3.3%
LEAD-5, 26 weeks, with metformin and glimepiride [3]1.8 mg 13.9%Placebo 3.5%; insulin glargine 1.3%
Trial 1860, 26 weeks, with metformin [3]1.2 mg 20.8%; 1.8 mg 27.1%Sitagliptin 4.6%
LEAD-3, 52 weeks, Victoza® alone [3]1.2 mg 27.5%; 1.8 mg 29.3%Glimepiride 8.5%
LEADER, median 3.5 years on treatment, high cardiovascular risk [1][3]3.7%Placebo 0.9%
EU frequency class [2]Very common (1 in 10 or more)—

When it tends to happen

Timing is where the Canadian data are most useful. Across the pooled long-term trials, roughly 13% of people on Victoza® and 2% on comparators reported nausea in the first two weeks. [3] In trial 1860 the first-fortnight figures were 16.3% on 1.2 mg and 17.4% on 1.8 mg, against 2.7% on sitagliptin. [3] In trial 1842, 18.9% of people on 1.8 mg with metformin reported nausea during the first 12 weeks, but only 1.9% did so during the following 52 weeks. [3]

The US label says withdrawals for stomach and bowel reactions happened mainly in the first two to three months. [1] The European leaflet describes nausea as something that usually goes away over time. [2] For most people, then, the pattern is an early peak during the dose steps, not a steady effect for as long as the medicine is used.

Who is more likely to feel it

Background medicine matters. In European data, 20.7% of people taking liraglutide with metformin reported at least one episode of nausea, compared with 9.1% when it was combined with a sulfonylurea. [2] A systematic analysis of 32 published phase 3 trials of GLP-1 medicines, with liraglutide as one of its reference drugs, also found more nausea and vomiting when metformin was the background treatment, and a clear link between higher doses and more nausea. [4] That is an analysis of published trials, not a test of individual patients, so it describes averages.

Age and kidney function are named too. The EU product information says people over 70 and those with mild or moderate kidney impairment may have more digestive effects on liraglutide. [2] Canada adds that the rate of digestive events rose with age, especially at 1.8 mg. [3] For young people, the paediatric trial behind the 10-and-over approval found more digestive side effects with liraglutide than with placebo. [11]

Why it might happen

Label-supported: the US prescribing information says liraglutide delays gastric emptying as part of how it lowers blood sugar after meals. [1] The EU text calls this a minor delay. [2] Food leaving the stomach more slowly is the most direct, documented link between Victoza® and feeling sick.

Studied but not settled: in a five-week crossover trial in adults with obesity but without diabetes, liraglutide 1.8 mg, the top Victoza® dose, increased feelings of fullness and reduced hunger; its effect on stomach emptying over five hours was equivalent to placebo, with a smaller, non-significant slowing in the first hour. [5] That population differs from Victoza® users, and the trial did not measure nausea as its main outcome, so it hints at a mechanism rather than proving one.

General medicine: MedlinePlus names “glutides”, medicines used for diabetes or obesity, among the treatments that commonly cause nausea and vomiting. [6]

Other causes to keep in mind

Nausea has many sources that have nothing to do with an injection. MedlinePlus lists stomach infections, food poisoning, reflux, migraine, pregnancy, motion sickness, severe pain such as kidney stones and slow stomach emptying, and it names appendicitis and bowel blockage among the serious problems that can begin with nausea. [6] Diabetes itself is the most common known cause of gastroparesis, a condition in which the stomach empties too slowly, according to NIDDK. [8] The Victoza® label says the medicine is not recommended for people with severe gastroparesis. [1]

Steps the leaflets and MedlinePlus describe

  • The 0.6 mg first week: the US label says this starting step exists to lower the risk of digestive reactions and does not itself control blood sugar in adults; the next step comes after at least a week. [1]
  • Breaks in treatment: the US label restarts at 0.6 mg if more than 3 days have passed since the last dose, because restarting carries its own stomach risk. The EU leaflet and the Canadian patient information give their own missed-dose instructions without the 3-day restart, so follow the rule your prescriber and your leaflet give you. [1][2][3]
  • Fluids: the Medication Guide asks you to drink fluids to lower the chance of dehydration. [1]
  • Eating: MedlinePlus suggests sitting quietly when you feel sick, eating several small bland meals instead of large ones, sitting up after eating, and avoiding greasy or very spicy food, strong smells, caffeine, alcohol and fizzy drinks. [7]
  • Medicines for nausea: MedlinePlus says your provider may suggest one; ask your prescriber or pharmacist rather than adding one on your own. [7]

Stopping, severe reactions and too much medicine

The US label does not give a separate stop rate for nausea. For all stomach and bowel reactions together, 4.3% of adults on Victoza® left the trials because of them, against 0.5% on placebo, and severe digestive reactions were reported by 4.4% on 1.2 mg and 4.2% on 1.8 mg, compared with 1.1% on placebo. [1] In the EU’s long-term trials, nausea alone led 2.8% of people to stop. [2]

Severe nausea and vomiting are also listed among the effects of an overdose. [1] The Medication Guide points you to your provider, the Poison Help line or an emergency room if you take 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

  • Vomit that contains blood or looks like coffee grounds

    Contact: Emergency services (911 or local number)

    MedlinePlus [6]

  • Severe stomach pain that does not go away, sometimes reaching the back, with or without vomiting

    Contact: Stop Victoza® and call your provider straight away

    Medication Guide [1]

  • Possible overdose: severe nausea or vomiting after taking too much

    Contact: Your provider, Poison Help or an emergency room

    Medication Guide [1]

Today

  • Nausea with vomiting for more than 24 hours, no fluids kept down for 12 hours, or no urine for 8 hours

    Contact: Your provider, the same day

    MedlinePlus [6]; Medication Guide [1]

  • Nausea that keeps going for more than 48 hours, with weakness or fever

    Contact: Contact your provider

    MedlinePlus [7]

At your next appointment

  • Mild nausea that is wearing you down or keeps you from eating

    Contact: Raise it with your prescriber

    Medication Guide [1]

Questions

How common is nausea on Victoza®?

In the US label’s pool of five placebo-controlled adult trials, 18% of people on 1.2 mg and 20% on 1.8 mg reported nausea, against 5% on placebo. [1] Individual Canadian trial figures range from 10.7% to 29.3% depending on dose and background medicine. [3]

Does nausea from Victoza® wear off?

For most people it eases. The EU leaflet says it usually goes away over time, and in trial 1842 nausea dropped from 18.9% in the first 12 weeks to 1.9% over the following year. [2][3]

I take metformin too. Does that change anything?

European data show more nausea when liraglutide was combined with metformin (20.7%) than with a sulfonylurea (9.1%), and an analysis of published trials linked metformin background with more nausea across GLP-1 medicines. [2][4] It is still your prescriber who decides how both medicines are used.

My 13-year-old has just started Victoza® and feels sick. Is that expected?

The label says reactions in patients aged 10 and older were similar in type and severity to adults, and the paediatric trial reported more digestive side effects with liraglutide than with placebo. [1][11] Children step up in 0.6 mg increments, each after at least a week; tell their prescriber if nausea is severe or stops them eating or drinking. [1]

Will generic liraglutide cause less nausea than Victoza®?

There is no reason to expect a difference. The FDA lists nausea first among the most common side effects of the generic it approved in December 2024, and says approved generics carry the same risks and benefits as the brand. [9][10]

I missed several days of Victoza®. Will the nausea come back when I restart?

It might, which is why the US label restarts at 0.6 mg once more than 3 days have passed, and leaves later steps to your prescriber. [1] Check with them before your next injection.

Sources

Sources checked on

  1. VICTOZA® (liraglutide) injection Prescribing Information and Medication Guide, Novo Nordisk Revised 10/2025; Medication Guide 05/2025. Sections 2.1, 2.2, 5.6, 6.1 (Table 1 and gastrointestinal text), 8.4, 10 and 12.1–12.2.
  2. Victoza: EPAR – Product Information (SmPC and package leaflet), European Medicines Agency SmPC sections 4.2, 4.4 and 4.8 (Table 1 read from the PDF page image; gastrointestinal and withdrawal text); package leaflet sections 3 and 4.
  3. VICTOZA® (liraglutide injection) Product Monograph, Novo Nordisk Canada Inc. (Health Canada Drug Product Database) Date of authorization 2025-08-21. Sections 8.1 and 8.2 (Tables 1–5 read from the PDF page images; gastrointestinal adverse events text).
  4. Bettge K et al. Occurrence of nausea, vomiting and diarrhoea reported as adverse events in clinical trials studying glucagon-like peptide-1 receptor agonists: a systematic analysis of published clinical trials. Diabetes Obes Metab 2017 Systematic analysis of 32 phase 3 trials; PubMed abstract.
  5. van Can J et al. Effects of the once-daily GLP-1 analog liraglutide on gastric emptying, glycemic parameters, appetite and energy metabolism in obese, non-diabetic adults. Int J Obes 2014 Randomised crossover trial, 49 adults without diabetes; PubMed abstract.
  6. Nausea and vomiting – adults, MedlinePlus Medical Encyclopedia (U.S. National Library of Medicine)
  7. When you have nausea and vomiting, MedlinePlus Medical Encyclopedia
  8. Gastroparesis, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  9. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes, U.S. FDA Press announcement, 23 December 2024.
  10. Generic Drug Facts, U.S. FDA
  11. Tamborlane WV et al. Liraglutide in children and adolescents with type 2 diabetes (Ellipse). N Engl J Med 2019 Randomised controlled trial, 134 participants aged 10 to 16; PubMed abstract.

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