What Foundayo™ documents say about urine
Foundayo™ is a daily orforglipron tablet approved in the US for weight management [1]. Neither its Prescribing Information nor its Medication Guide lists frequent or urgent urination [1][2]. The entries that do touch the urinary tract are about fluid loss: acute kidney injury was reported in 0.2% of treated adults against 0.05% on placebo, mostly after stomach side effects caused dehydration [1].
Orforglipron is broken down in the liver and its products pass into the gut, so very little reaches the urine [1]. No European or Canadian product information is available for comparison: the EMA’s committee gave a positive opinion in October 2026 with no EMA product information yet, and Health Canada lists no Foundayo™ product [3][4].
| Source | Frequent urination | Related entry |
|---|---|---|
| US Prescribing Information [1] | Not listed | Acute kidney injury 0.2% vs 0.05% on placebo; less than 1% of a dose in urine |
| US Medication Guide [2] | Not listed | Drink fluids to lower the chance of dehydration |
| European Medicines Agency [3] | No product information yet | Positive opinion of 15 October 2026 |
| Health Canada [4] | No entry found | No product monograph |
Urinary entries in the trial registries
The two weight trials behind the label, ATTAIN-1 and ATTAIN-2, posted non-serious events only when they reached 5% of a group [5][6]. Three diabetes trials posted every event [7][8][9]. Their trial doses of 3, 12 and 36 mg are not Foundayo™ tablet strengths, and treating type 2 diabetes is outside the US indication [1].
| Trial [source] | Entry | Comparison group | Orforglipron, low to high dose |
|---|---|---|---|
| ATTAIN-2, obesity with type 2 diabetes [6] | Urinary tract infection | Placebo 24/628 (3.8%) | 13/328 (4.0%); 18/331 (5.4%); 16/321 (5.0%) |
| ATTAIN-1, obesity without diabetes [5] | Urinary tract infection, serious | Placebo 1/948 | 1/723; 0/724; 1/728 (non-serious cases under 5% in every group) |
| ACHIEVE-1, double blind [7] | Frequent urination | Placebo 0/138 | 2/143; 0/137; 0/141 |
| ACHIEVE-5, double blind, with insulin [9] | Frequent urination; urinary tract infection | Placebo 1/140; 6/140 | None; 2/137, 3/132, 4/135 |
| ACHIEVE-2, open label [8] | Passing large amounts of urine; urinary tract infection | Dapagliflozin 1/240; 12/240 | 0, 1 and 0 of about 240; 8/240, 3/241, 5/241 |
Reading the urinary numbers
- Frequent urination was reported by at most two people in a group of 130 to 240, and a placebo group had a case too [7][9].
- In ATTAIN-2, urinary tract infections were a little more common on the two higher doses than on placebo; the registry gives no test of whether that gap is more than chance [6].
- In ACHIEVE-5 the pattern ran the other way, with the most infections on placebo [9].
- Dapagliflozin, an SGLT-2 inhibitor, had the most infections in ACHIEVE-2. That trial was open label, so people knew which medicine they were taking [8].
Why you might still be going more often
Drinking more: the Foundayo™ Medication Guide asks you to drink fluids to lower the chance of dehydration [2], and more fluid in means more urine out. That is the intended effect, not a side effect.
Blood sugar: MedlinePlus lists urinating often among the signs of high blood sugar [13]. In Trial 2, adults with type 2 diabetes saw HbA1c fall by 1.2 to 1.7 percentage points on Foundayo™ against 0.4 on placebo [1], so in diabetes frequent urination is more a reason to check glucose than a sign of the tablet.
Other medicines: in a Medicare cohort, SGLT-2 inhibitors were linked to higher 24-hour urine volume, while GLP-1 medicines showed no change [10]. MedlinePlus also names diuretics (water pills) [11]. Half of the people in the label’s trials had high blood pressure, and Trial 2 allowed oral diabetes medicines other than DPP-4 inhibitors [1].
Sleep apnea: NHLBI lists waking often at night to urinate among its symptoms [15], and 11% of the label’s trial population had obstructive sleep apnea [1]. Foundayo™ is not approved in the US to treat sleep apnea [1].
Other everyday causes
MedlinePlus lists common and less common reasons for needing to urinate often or urgently [11]:
- A urinary tract infection, or swelling and infection of the urethra.
- An enlarged prostate in middle-aged and older men; vaginitis in women.
- Caffeine and alcohol.
- Anxiety, nerve-related problems, spine problems or a stroke.
- Pregnancy, overactive bladder, interstitial cystitis or, rarely, a bladder tumour.
The change that matters more: less urine
The Foundayo™ label is concerned with too little fluid, not too much urine. Nausea, vomiting and diarrhoea were common in the trials, especially while the dose was being raised, and the label links them to the reported cases of kidney injury [1]. MedlinePlus lists not urinating much, or very dark yellow urine, among the signs of dehydration, along with thirst, a dry mouth and dizziness [14].
So a drop in urine during a bout of vomiting or diarrhoea is the urinary change that needs a call. The Medication Guide asks you to tell your provider right away if nausea, vomiting or diarrhoea does not go away [2].
What general guidance suggests
MedlinePlus suggests writing down when you urinate and roughly how much, a record called a voiding diary, and bringing it to your appointment [11]. For night-time urination it suggests not drinking a lot before bed and cutting down on drinks that contain alcohol or caffeine [11].
Cutting fluids during the day to avoid bathroom trips is not part of that advice, and it works against the Medication Guide’s request to drink enough on Foundayo™ [2][11]. If urination stays frequent, the cause is something to work out with your provider, who may test your urine or blood sugar [11][13].
Foundayo™ is a trademark of Eli Lilly and Company. PepLabo is not affiliated with or endorsed by Eli Lilly and Company.
When to get help
The signs and contact information below come from this article’s sourced guidance.
Today
- Urinary symptoms with fever, back or side pain, vomiting or shaking chills
Contact: Your provider, right away
MedlinePlus [11]
- Very little or very dark urine with thirst or dizziness after vomiting or diarrhoea
Contact: Your prescriber, right away
- Frequent urination with more thirst or appetite, tiredness or sudden weight loss
Contact: Your provider, right away; check blood sugar if you have diabetes
- Burning when you urinate, or cloudy or reddish urine
Contact: Your doctor for a urine test
MedlinePlus [12]