Foundayo Side Effects by Dose: Rates From ATTAIN
In the Foundayo label, nausea is the most common side effect: 35% on 17.2 mg vs 10% on placebo. Next come constipation and diarrhea.
- Most common
- Nausea 35%
- Same on placebo
- 10%
- Stopped because of side effects
- 8%
- Trial group
- Adults with obesity or overweight (weight management)
Foundayo in brief
Its half-life ranges from 29 to 49 hours. Half remains after 39 h. After five half-lives, about 3% remains (8.1 d).
In ATTAIN-1 at 72 weeks, the body weight result was 11.1%, compared with 2.1% on placebo.
Monthly prices in US dollars include the list price and self-pay offers. Each amount comes from the maker's price page.
Sources: FDA label (DailyMed), Eli Lilly, pricinginfo.lilly.com.
Foundayo side effects: label rates vs placebo
The FDA label lists 13 common Foundayo side effects found in placebo-controlled trials. The final column shows how much more often each side effect appeared than with placebo.
| Side effect | Placebo | Foundayo 5.5 mg | Foundayo 9 mg | Foundayo 17.2 mg | More than placebo, 17.2 mg |
|---|---|---|---|---|---|
| Nausea | 10% | 26% | 34% | 35% | +25 points |
| Constipation | 9% | 20% | 27% | 24% | +15 points |
| Diarrhea | 11% | 21% | 23% | 25% | +14 points |
| Vomiting | 4% | 13% | 21% | 24% | +20 points |
| Dyspepsia | 4% | 12% | 16% | 13% | +9 points |
| Abdominal pain | 7% | 13% | 14% | 14% | +7 points |
| Headache | 7% | 8% | 9% | 9% | +2 points |
| Abdominal distension | 3% | 7% | 9% | 8% | +5 points |
| Fatigue | 4% | 6% | 7% | 9% | +5 points |
| Eructation | 1% | 6% | 8% | 8% | +7 points |
| Gastroesophageal reflux disease | 2% | 6% | 6% | 7% | +5 points |
| Flatulence | 2% | 5% | 6% | 6% | +4 points |
| Hair loss | 2% | 4% | 4% | 5% | +3 points |
Source: the FDA DailyMed label.
Serious warnings in plain terms
- A boxed warning applies to thyroid C-cell tumors. In rodents, it caused thyroid C-cell tumors; whether it causes them in people is not known. Avoid it if you have MEN 2, or if you or a family member has had medullary thyroid cancer (MTC).
- Pancreatitis It may lead to inflammation of the pancreas. If severe stomach pain does not go away, stop taking it and get care. This pain may reach your back.
- Stomach and gut reactions can be severe. Stomach and gut effects often occur, and some may be severe. This is not recommended if you have severe gastroparesis.
- Fluid loss is a cause of kidney injury. Vomiting or diarrhea can cause fluid loss, and that can lead to kidney injury. Report heavy fluid loss, and continue drinking fluids.
- Low blood sugar. Combining it with insulin or a sulfonylurea makes low blood sugar more likely. The doses of those medicines may need to be reduced.
- Allergic reactions may be serious. Face, lip or throat swelling has been reported among serious allergic reactions. If they happen, stop taking it and get help right away.
- Worsening diabetic eye disease For people with type 2 diabetes, diabetic eye disease may worsen, especially if blood sugar falls quickly. If you already have it, eye checks are important.
- Gallbladder disease. You may develop gallstones or inflammation of the gallbladder. Right upper belly pain, fever, yellow skin or eyes should be reported.
- Food can reach the lungs while you are under anesthesia or sedation. Food may remain in your stomach longer, which matters while receiving anesthesia or deep sedation. Tell your care team before you have any procedure.
Source: the FDA DailyMed label.
Source: the FDA DailyMed label.