Tirzepatide Long-Term Side Effects: What Years of Data Show
Mounjaro has been sold in the US since 2022. The long-term label warnings are thyroid C-cell tumors (seen in rodents), pancreatitis, gallbladder disease and kidney injury from fluid loss.
- Sold in the US since
- 2022
- Most common
- Nausea 18%
- Same on placebo
- 4%
- Trial group
- Adults with type 2 diabetes
Zepbound facts at a glance
The half-life is 5 to 6 days. After 5.5 d, half is gone, and about 3% remains after five half-lives (27.5 d).
The 72-week SURMOUNT-1 result was 20.9% of body weight, versus 3.1% on placebo.
The maker's price page shows monthly price points in US dollars, covering the list price and self-pay offers.
Sources: FDA label (DailyMed), Eli Lilly 1 2, cnbc.com.
Serious warnings in plain language
- Thyroid C-cell tumors carry a boxed warning. Giving it to rodents caused thyroid C-cell tumors. Do not take it if you or your family have a history of medullary thyroid cancer (MTC), or if you have MEN 2.
- Pancreatitis. May cause the pancreas to become inflamed. Get care and stop taking it when stomach pain is severe and will not let up, and it may reach your back.
- Low blood sugar. It is more likely to cause low blood sugar when used with insulin or a sulfonylurea, so those doses may need to be lowered.
- Allergic reactions that are severe. Reports include serious allergic reactions with swelling affecting the face, lips, or throat. Get medical help right away if
- Kidney injury from fluid loss. Fluid loss from vomiting or diarrhea may lead to kidney injury. You need to report heavy fluid loss and drink fluids.
- Severe stomach and gut reactions. Stomach and gut side effects occur often, and some may be severe. It is not recommended for people with severe gastroparesis.
- Worsening diabetic eye disease With type 2 diabetes, your diabetic eye disease may get worse, particularly if your blood sugar drops quickly. Eye checks matter if you already have it.
- Gallbladder disease The gallbladder may develop gallstones or become inflamed. Report a fever, yellow skin or yellow eyes, or upper right belly pain.
- During anesthesia or sedation, food in your lungs. Food may stay in your stomach longer, and that matters during anesthesia or deep sedation. Tell your care team before you have any procedure.
Source: the FDA DailyMed label.
Source: the FDA DailyMed label.
Tirzepatide long term side effects: label rates vs placebo
The drug Tirzepatide is sold as Mounjaro and Zepbound. Each label includes its own table, based on different groups of people.
Mounjaro
| Side effect | Placebo | Mounjaro 5 mg | Mounjaro 10 mg | Mounjaro 15 mg | More than placebo, 15 mg |
|---|---|---|---|---|---|
| Nausea | 4% | 12% | 15% | 18% | +14 points |
| Diarrhea | 9% | 12% | 13% | 17% | +8 points |
| Decreased Appetite | 1% | 5% | 10% | 11% | +10 points |
| Vomiting | 2% | 5% | 5% | 9% | +7 points |
| Dyspepsia | 3% | 8% | 8% | 5% | +2 points |
| Constipation | 1% | 6% | 6% | 7% | +6 points |
| Abdominal Pain | 4% | 6% | 5% | 5% | +1 points |
Source: the FDA DailyMed label.
Zepbound
| Side effect | Placebo | Zepbound 5 mg | Zepbound 10 mg | Zepbound 15 mg | More than placebo, 15 mg |
|---|---|---|---|---|---|
| Nausea | 8% | 25% | 29% | 28% | +20 points |
| Diarrhea | 8% | 19% | 21% | 23% | +15 points |
| Constipation | 5% | 17% | 14% | 11% | +6 points |
| Vomiting | 2% | 8% | 11% | 13% | +11 points |
| Abdominal Pain | 5% | 9% | 9% | 10% | +5 points |
| Dyspepsia | 4% | 9% | 9% | 10% | +6 points |
| Injection Site Reactions | 2% | 6% | 8% | 8% | +6 points |
| Fatigue | 3% | 5% | 6% | 7% | +4 points |
| Hypersensitivity Reactions | 3% | 5% | 5% | 5% | +2 points |
| Eructation | 1% | 4% | 5% | 5% | +4 points |
| Hair Loss | 1% | 5% | 4% | 5% | +4 points |
| Gastroesophageal Reflux Disease | 2% | 4% | 4% | 5% | +3 points |
| Dizziness | 2% | 4% | 5% | 4% | +2 points |
| Flatulence | 2% | 3% | 3% | 4% | +2 points |
| Abdominal Distension | 2% | 3% | 3% | 4% | +2 points |
| Hypotension | 0% | 1% | 1% | 2% | +2 points |
Source: the FDA DailyMed label.