GLP-1 kidney and dehydration warning: what the labels say
Short answer: every US label for Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Saxenda, Victoza and Trulicity has a warning titled Acute Kidney Injury Due to Volume Depletion. It reports postmarketing cases of acute kidney injury, some needing hemodialysis, mostly in people whose nausea, vomiting or diarrhea led to dehydration. Only Wegovy and Zepbound give a trial rate (both small). The Canadian product monographs add a clearer line on end-stage kidney disease: five of the eight say use is not recommended.
On this page: US label warning · Trial rates · Severe GI rates · Canada and ESRD · Hepatic impairment · Ozempic and CKD · What to log
The US warning, label by label
The wording is almost identical across the eight US labels on DailyMed (checked November 4, 2026): "There have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis... The majority of the reported events occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea." Each label then tells prescribers to monitor renal function in patients reporting side effects that could lead to volume depletion, "especially during dosage initiation and escalation."
| Medication | Section | Warning | Trial or postmarketing data (US label) | Renal impairment (section 8.6) |
|---|---|---|---|---|
| Ozempic (semaglutide) | 5.6 | Postmarketing AKI, some requiring hemodialysis | No trial rate given; AKI listed in postmarketing reactions | No dose adjustment recommended |
| Wegovy (semaglutide) | 5.5 | Postmarketing AKI, some requiring hemodialysis | 7 patients, 0.4 per 100 patient-years vs 4 on placebo (0.2); +2 with dehydration in other trials | Risk higher with history of renal impairment and during titration |
| Rybelsus / Ozempic tablets | 5.5 | Postmarketing AKI, some requiring hemodialysis | No trial rate given; AKI listed in postmarketing reactions | Same dosage as normal kidney function; studied in 324 patients with moderate impairment |
| Mounjaro (tirzepatide) | 5.5 | Postmarketing AKI with GLP-1 RAs or Mounjaro, some requiring hemodialysis | No trial rate given; acute renal failure or worsening chronic renal failure listed postmarketing | No dose adjustment; monitor when starting or escalating if severe GI reactions |
| Zepbound (tirzepatide) | 5.3 | Postmarketing AKI with GLP-1 RAs or Zepbound, some requiring hemodialysis | 0.5% vs 0.2% on placebo (SURMOUNT-1 and -2 pool) | No dose adjustment; monitor if side effects could cause volume depletion |
| Saxenda (liraglutide) | 5.6 | Postmarketing AKI, some requiring hemodialysis | No AKI rate; 1 patient with hypotension, GI reactions and renal failure | Limited experience in mild to severe impairment and ESRD |
| Victoza (liraglutide) | 5.5 | Postmarketing AKI, some requiring hemodialysis | No trial rate given; acute renal failure and increased serum creatinine listed postmarketing | No dose adjustment recommended |
| Trulicity (dulaglutide) | 5.5 | Postmarketing AKI with GLP-1 RAs including Trulicity, some requiring hemodialysis | No trial rate given; acute renal failure or worsening chronic renal failure listed postmarketing | No overall safety differences by renal function; monitor if severe GI reactions |
The Mounjaro, Zepbound and Trulicity labels phrase it as reports "in patients treated with GLP-1 receptor agonists," including their own product, rather than naming only their drug. The Wegovy label is the only one that says renal adverse reactions were more common in adults with a history of renal impairment, based on 65 such patients in its trials.
How often it happened in trials
- Wegovy: acute kidney injury in 7 adults in the weight-reduction trials (0.4 cases per 100 patient-years) vs 4 on placebo (0.2). Some occurred with GI reactions or dehydration, and 2 more Wegovy patients had acute kidney injury with dehydration in other trials. The Canadian monograph reports the same numbers.
- Zepbound: 0.5% vs 0.2% on placebo in the US pool of SURMOUNT-1 and -2. The Canadian monograph gives the same 0.5% vs 0.2% for a pool of three trials (SURMOUNT-1, -2 and -3).
- The other six: no acute kidney injury trial rate in the US label. Ozempic, Rybelsus and Saxenda list acute kidney injury among postmarketing reports; Mounjaro, Trulicity and Victoza list acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis (Victoza and Saxenda also list increased serum creatinine).
Postmarketing reports come from voluntary reporting, so the labels do not give a rate for them. Trial rates also come from different populations and durations; compare each drug with its own placebo group, not across rows.
Severe GI side effects: the trigger the labels point to
Because the kidney warning is tied to fluid loss, the "Severe Gastrointestinal Adverse Reactions" section that now sits next to it in each US label is the most useful context. These are the severe GI rates each label reports from its trials. The strengths shown are the trial arms in the label, not a dosing suggestion.
| Medication | Severe GI reactions on the drug | Placebo |
|---|---|---|
| Ozempic | 0.4% (0.5 mg), 0.8% (1 mg) | 0% |
| Wegovy | 4.1% injection, 2% tablets | 0.9% (injection placebo), 0% (tablet placebo) |
| Rybelsus / Ozempic tablets | 0.6% (7 mg), 2% (14 mg) | 0.3% |
| Mounjaro | 1.3% (5 mg), 0.4% (10 mg), 1.2% (15 mg) | 0.9% |
| Zepbound | 1.7% (5 mg), 2.5% (10 mg), 3.1% (15 mg) | 1% |
| Saxenda | 4.8% | 1.4% |
| Victoza | 4.4% (1.2 mg), 4.2% (1.8 mg) | 1.1% |
| Trulicity | 2.2% (0.75 mg), 4.3% (1.5 mg) | 1.4% |
Every US label also says the drug is not recommended in people with severe gastroparesis. Low blood pressure is mentioned alongside dehydration on two labels: Zepbound reports hypotension in 1.6% vs 0.1% on placebo (2.2% in people on blood pressure medication), "also in association with gastrointestinal adverse events and dehydration," and Saxenda reports hypotension-related reactions in 1.1% vs 0.5%.
Canada: dehydration advice and end-stage kidney disease
The Canadian monographs (section 7, Warnings and Precautions, under Renal) carry the same postmarketing message, often adding that some cases occurred "in patients without known underlying renal disease." Several also tell prescribers to advise patients of the dehydration risk and to take precautions to avoid fluid depletion. Where they differ most from the US labels is end-stage kidney disease.
| Monograph | Renal warning (summary) | End-stage kidney disease | Monograph date |
|---|---|---|---|
| Ozempic | Caution when starting or escalating in renal impairment; monitor if severe GI reactions | Experience in end-stage kidney disease very limited | 2026-07-13 |
| Wegovy | Advise patients of dehydration risk and to avoid fluid depletion; renal impairment may raise AKI risk | Not recommended in end-stage renal disease | 2025-12-10 |
| Rybelsus | Monitor renal function, especially with severe GI side effects | Experience in end-stage kidney disease limited | 2026-07-13 |
| Mounjaro | Dehydration could cause deterioration in renal function including acute renal failure; monitor when starting or escalating if severe GI reactions | Not recommended in end-stage renal impairment | 2026-06-23 |
| Zepbound | Same wording as Mounjaro; AKI 0.5% vs 0.2% placebo (SURMOUNT-1, -2 and -3 pool) | Not recommended in end-stage renal impairment | 2026-06-11 |
| Saxenda | Advise of dehydration risk; caution when starting or escalating in renal insufficiency | Not recommended in severe renal insufficiency including ESRD | 2022-12-09 (revision) |
| Victoza | Advise of dehydration risk; use caution in patients who experience dehydration | Not recommended in end-stage renal disease | 2022-12-09 (revision) |
| Trulicity | Advise of dehydration risk; caution when starting or escalating in renal impairment | Limited experience in ESRD (eGFR under 15); use with caution | 2024-07-05 (revision) |
The Saxenda monograph adds that people with moderate renal insufficiency may experience more fatigue and GI side effects. The Victoza monograph says no dose adjustment is required for mild, moderate or severe renal insufficiency but that use in end-stage renal disease is not recommended. None of the US labels we checked uses "not recommended" for end-stage kidney disease.
Hepatic impairment: what the labels say about liver disease
Kidney warnings are only half of the organ-impairment story. Every product also addresses hepatic impairment — usually in US label section 8.7 (Use in Specific Populations) and in the Canadian monograph under Hepatic Insufficiency / Hepatic Impairment. The pattern differs by molecule: semaglutide and tirzepatide labels generally say exposure does not change in a clinically relevant way, while liraglutide and dulaglutide labels report lower exposure and ask for caution because clinical experience is limited. None of the wording below is a dosing suggestion — your prescriber decides.
| Medication | US section | US hepatic wording (summary) | PK / study note (US label) |
|---|---|---|---|
| Ozempic (semaglutide) | 8.7 | No dose adjustment recommended | No clinically relevant PK change in mild, moderate or severe hepatic impairment (single-dose 0.5 mg study) |
| Wegovy (semaglutide) | 12.3 (no numbered 8.7) | No dedicated 8.7 section; PK states no clinically significant difference | Mild, moderate and severe hepatic impairment (Child-Pugh A–C) and MASH fibrosis F2/F3: no clinically significant PK difference |
| Rybelsus / Ozempic tablets | 8.7 | Recommended dosage same as normal hepatic function | No clinically relevant PK change in mild, moderate or severe hepatic impairment (Child-Pugh) |
| Mounjaro (tirzepatide) | 8.7 | No dosage adjustment recommended | No change in tirzepatide PK in mild, moderate or severe hepatic impairment (single 5 mg dose) |
| Zepbound (tirzepatide) | 8.7 | No dosage adjustment recommended | No change in tirzepatide PK in mild, moderate or severe hepatic impairment (single 5 mg dose) |
| Saxenda (liraglutide) | 8.7 | Use with caution; limited experience in mild, moderate or severe impairment | Single-dose PK: AUC about 11%, 14% and 42% lower in mild, moderate and severe vs healthy subjects |
| Victoza (liraglutide) | 8.7 | Use with caution; limited experience; no dose adjustment recommended | Same single-dose PK pattern as Saxenda (AUC about 11%, 14% and 42% lower) |
| Trulicity (dulaglutide) | 8.7 | Use with caution; limited clinical experience in mild, moderate or severe impairment | Exposure decreased about 23%, 33% and 21% for mild, moderate and severe; Cmax fell similarly; still described as not clinically relevant for PK |
Wegovy is the outlier on structure: the current US label (checked November 7, 2026) folds hepatic impairment into Clinical Pharmacology rather than a numbered 8.7 section, and it is also indicated for noncirrhotic MASH with moderate to advanced fibrosis (F2–F3) under accelerated approval. That indication is separate from the general “hepatic impairment” caution that still appears in the Canadian monograph.
Canada: hepatic insufficiency by monograph
Canadian monographs often sound more cautious than the matching US 8.7 section, even when the PK study is the same. Saxenda is the clearest split: the US label says use with caution, while the Canadian monograph says use in hepatic insufficiency is not recommended.
| Monograph | Hepatic wording (summary) | PK note | Monograph date |
|---|---|---|---|
| Ozempic | Use with caution: safety and efficacy in hepatic insufficiency not studied (no Phase 3 with hepatic insufficiency) | Single-dose 0.5 mg: hepatic insufficiency did not impact semaglutide exposure (mild, moderate, severe) | 2026-07-13 |
| Wegovy | Use with caution: efficacy and safety in hepatic insufficiency not studied; specifically caution in Child-Pugh C (unstudied) | Hepatic insufficiency did not impact exposure (mild, moderate, severe, single-dose 0.5 mg); MASH F4c experience limited | 2025-12-10 |
| Rybelsus | No dose adjustment recommended based on hepatic impairment; limited clinical experience in mild, moderate or severe hepatic insufficiency | CA special-populations PK list names renal impairment; hepatic PK detail is in the US label (8.7 / 12.3) | 2026-07-13 |
| Mounjaro | No dose adjustment recommended; use with caution — limited clinical experience in mild, moderate or severe hepatic impairment | Hepatic impairment does not impact tirzepatide PK (single 5 mg; mild, moderate, severe) | 2026-06-23 |
| Zepbound | No dose adjustment recommended; use with caution — limited clinical experience in mild, moderate or severe hepatic impairment | Hepatic impairment does not impact tirzepatide PK (single 5 mg; mild, moderate, severe) | 2026-06-11 |
| Saxenda | Use in patients with hepatic insufficiency is not recommended (safety and efficacy not studied) | Single-dose 0.75 mg: AUC lower by about 23%, 13% and 44% in mild, moderate and severe vs healthy subjects | 2025-09-10 |
| Victoza | Limited clinical experience in mild, moderate or severe hepatic insufficiency; no dose adjustment required | Single-dose: AUC lower by about 23%, 13% and 44% in mild, moderate and severe vs healthy subjects | 2025-08-21 |
| Trulicity | Use with caution; limited experience in mild, moderate or severe hepatic impairment; no dose adjustment required | 1.5 mg study: exposure down up to about 30–33% for mean Cmax and AUC vs healthy controls | 2024-07-05 (revision) |
For related class warnings that often show up alongside organ impairment, see GLP-1 severe gastrointestinal adverse reactions (the usual trigger for dehydration-related kidney injury) and GLP-1 drug interactions.
Ozempic and chronic kidney disease (FLOW)
The warning is about dehydration, not about the drugs harming healthy kidneys over time. In fact, Ozempic now has a kidney indication in both countries: to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. In the FLOW trial (3,533 adults, eGFR 25 to 75), the main kidney composite occurred in 331 of 1,767 patients (18.7%) on Ozempic 1 mg vs 410 of 1,766 (23.2%) on placebo, a hazard ratio of 0.76 (US label, Table 10). A sustained eGFR decline of 50% or more occurred in 9.3% vs 12.1%.
What to log and tell your prescriber
- Any kidney disease, a recent eGFR or creatinine result, or dialysis, before you start.
- Any liver disease, cirrhosis, MASH/NASH, or abnormal liver tests, before you start — the hepatic sections above are why that matters.
- Vomiting or diarrhea: the date it started, how many times a day, and how many days it lasted. The US labels ask patients to report persistent or extended nausea, vomiting and diarrhea promptly.
- Whether you could keep fluids down. The Medication Guides say it is important to drink fluids to help reduce the chance of dehydration.
- Dose changes, since the labels point to starting and escalating doses as the time to watch.
- Blood pressure medicines you take: the Zepbound label reports more hypotension in people on antihypertensives (2.2% vs 1.2%).
For the full severe-GI section numbers and Canadian gastroparesis wording, see GLP-1 severe gastrointestinal adverse reactions warning. For the other class warnings, see GLP-1 pancreatitis and gallbladder warnings, GLP-1 diabetic retinopathy warning, GLP-1 thyroid warning and contraindications, GLP-1 aspiration risk under anesthesia and GLP-1 side effects: rates and tracking.
Sources
- Ozempic prescribing information, sections 1, 5.6, 5.7, 6.2, 8.6, 8.7, 12.3, 14.3 and 17 (DailyMed, US)
- Wegovy prescribing information, sections 1, 5.5, 5.6, 6 and 12.3 hepatic PK (DailyMed, US)
- Rybelsus and Ozempic tablets prescribing information, sections 5.5, 5.6, 6.2, 8.6, 8.7 and 12.3 (DailyMed, US)
- Mounjaro prescribing information, sections 5.5, 5.6, 6.2, 8.6, 8.7 and 12.3 (DailyMed, US)
- Zepbound prescribing information, sections 5.2, 5.3, 6, 8.6, 8.7 and 12.3 (DailyMed, US)
- Saxenda prescribing information, sections 5.6, 5.7, 6, 8.6, 8.7 and 12.3 (DailyMed, US)
- Victoza prescribing information, sections 5.5, 5.6, 6.2, 8.6, 8.7 and 12.3 (DailyMed, US)
- Trulicity prescribing information, sections 5.5, 5.6, 6.2, 8.6, 8.7 and 12.3 (DailyMed, US)
- Ozempic product monograph, sections 1, 4, 7.1.6 Hepatic Insufficiency and 10.3 (Novo Nordisk Canada, 2026-07-13)
- Wegovy product monograph, sections 4, 7.1.5 Hepatic Insufficiency and 10 (Novo Nordisk Canada, 2025-12-10)
- Rybelsus product monograph, sections 4 (hepatic impairment) and 7 Hepatic/Biliary (Novo Nordisk Canada, 2026-07-13)
- Mounjaro product monograph, sections 4 Hepatic Insufficiency, 7.1.5 and 10.3 (Eli Lilly Canada)
- Zepbound product monograph, sections 4 Hepatic Insufficiency, 7.1.5 and 10.3 (Eli Lilly Canada)
- Saxenda product monograph, Hepatic Insufficiency (not recommended) and PK (Novo Nordisk Canada, 2025-09-10)
- Victoza product monograph, Hepatic Insufficiency and PK (Novo Nordisk Canada, 2025-08-21)
- Trulicity product monograph, Hepatic Insufficiency / 7.1.5 and 10.3 (Eli Lilly Canada)
This page summarizes official product labels as general information. It is not medical advice. Do not start, stop or change any medication without talking to your prescriber. Labels are updated; check the current version for your product.
Frequently asked questions
Can Ozempic, Wegovy, Mounjaro or Zepbound cause kidney damage?
All eight US labels covered here (Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Saxenda, Victoza and Trulicity) carry a warning called "Acute Kidney Injury Due to Volume Depletion". It says there have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, and that the majority occurred in people whose nausea, vomiting or diarrhea led to dehydration. The labels describe it as a risk linked to fluid loss, not as a direct toxic effect on the kidneys.
How common was acute kidney injury in the trials?
Only two US labels give a trial rate. Wegovy: 7 adult patients in the weight-reduction trials (0.4 cases per 100 patient-years) vs 4 on placebo (0.2), plus 2 more Wegovy patients with acute kidney injury and dehydration in other trials. Zepbound: 0.5% vs 0.2% on placebo in the pool of SURMOUNT-1 and -2. The other labels list acute kidney injury or acute renal failure among postmarketing reports, which have no denominator.
Why does dehydration matter on a GLP-1?
The labels link the kidney warning to gastrointestinal side effects. The US Medication Guides say: "Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems," and "It is important for you to drink fluids to help reduce your chance of dehydration." The Wegovy, Saxenda, Victoza and Trulicity Canadian monographs say patients should be advised of the dehydration risk and take precautions to avoid fluid depletion.
When is the kidney risk highest?
The US labels tell prescribers to monitor kidney function in people reporting side effects that could lead to volume depletion, "especially during dosage initiation and escalation." The Wegovy label adds that renal adverse reactions occurred more frequently during dose titration and that the risk was increased in adults with a history of renal impairment.
Do I need a lower dose if I have kidney disease?
Dosing is your prescriber's decision; Glidedose does not suggest doses. For reference, the US labels for Ozempic, Rybelsus, Mounjaro, Zepbound and Victoza say no dose adjustment is recommended for renal impairment, the Trulicity label says no overall differences in safety or effectiveness were seen by renal function, and the Saxenda label says there is limited experience in renal impairment. The labels still ask for kidney monitoring when GI side effects are severe.
Can people on dialysis or with end-stage kidney disease use these drugs?
The Canadian monographs are more specific than the US labels here. Wegovy, Mounjaro, Zepbound, Saxenda and Victoza monographs say use is not recommended in end-stage renal disease (very limited experience). The Ozempic, Rybelsus and Trulicity monographs say experience is limited or very limited, and Trulicity says to use caution in ESRD (eGFR under 15). Ask your prescriber and nephrologist.
Is Ozempic approved to protect the kidneys?
Yes, in a specific group. The US Ozempic label and the Canadian monograph include an indication to reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease, based on the FLOW trial. In FLOW, the main kidney composite endpoint occurred in 18.7% on Ozempic 1 mg vs 23.2% on placebo (hazard ratio 0.76). The acute kidney injury warning still applies.
What should I report to my prescriber?
The US labels tell prescribers to instruct patients to promptly report signs or symptoms of acute kidney injury, or persistent (or extended) nausea, vomiting and diarrhea. Logging when vomiting or diarrhea started, how many days it lasted and how much you could drink makes that conversation easier.
Is low blood pressure part of the same warning?
The labels mention it alongside dehydration. The US Zepbound label reports hypotension in 1.6% on Zepbound vs 0.1% on placebo and says it also occurred in association with GI adverse events and dehydration. The US Saxenda label reports hypotension-related reactions in 1.1% vs 0.5%, including one Saxenda patient with hypotension associated with GI reactions and renal failure.
Do I need a lower dose if I have liver disease?
Dosing is your prescriber's decision; Glidedose does not suggest doses. For reference, the US labels for Ozempic, Rybelsus, Mounjaro and Zepbound say no dose adjustment is recommended for hepatic impairment (section 8.7), based on PK studies in mild, moderate and severe impairment. Victoza says limited experience but no dose adjustment recommended; Saxenda and Trulicity say use with caution because experience is limited. The Canadian monographs are often more cautious: Saxenda says use in hepatic insufficiency is not recommended, while Ozempic and Wegovy say use with caution because safety and efficacy have not been studied, and Rybelsus notes limited clinical experience in hepatic insufficiency.
Does liver disease change how these drugs work in the body?
For semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound), the US labels report no clinically relevant change in drug levels across mild, moderate and severe hepatic impairment. For liraglutide (Saxenda, Victoza), single-dose studies found lower exposure as impairment worsened (about 11%, 14% and 42% lower AUC for mild, moderate and severe vs healthy subjects on the Victoza US label; Saxenda reports similar direction). For dulaglutide (Trulicity), exposure was about 21% to 33% lower across impairment groups, which the label still calls not clinically relevant for PK, while asking for caution because clinical experience is limited.
Is Wegovy approved for a liver condition?
Yes, in a specific group. The US Wegovy injection label includes an indication for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (stages F2 to F3) in adults, under accelerated approval. That is a treatment indication, not a free pass for people with other forms of liver disease. The Canadian Wegovy monograph still says efficacy and safety in hepatic insufficiency have not been studied and to use caution, and specifically that severe hepatic insufficiency (Child-Pugh C) has not been studied.
Should I tell my prescriber about liver problems before starting a GLP-1?
Yes. Liver disease, cirrhosis, MASH/NASH or abnormal liver tests belong on the same checklist as kidney disease before you start. Logging baseline labs and any later jaundice, dark urine, pale stools or right-upper-abdominal pain makes that conversation easier. Glidedose is a GLP-1 tracker for doses and side effects with dates; it is not a substitute for labs or medical advice.
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