Tirzepatide Side Effects, From the Label Itself
Zepbound’s label reports every reaction seen in 2% or more of patients, dose by dose, each against its placebo rate. Here they all are, including the ones that do not get repeated in coverage.
- 29%Reported nausea at 10 mg, the peak, against 8% on placebo
- 6.7%Stopped at the top dose because of side effects, against 3.4% on placebo
- 8%Had injection site reactions — the cost of this one being an injection
- 2,519Adults in the safety population, followed for up to 72 weeks
The short version
The reactions are mostly digestive, they cluster in the first few months rather than persisting, and they are not as strictly dose-dependent as people assume. Nausea actually peaks at the middle dose, and constipation is reported less often at 15 mg than at 5 mg.
Read every figure against its placebo column. Eight percent of people reported nausea while taking placebo, so the drug’s contribution is the gap between the columns, not the headline number. This page reports what the label reports; it is not a guide to managing side effects, and nothing here is a reason to change a prescribed medicine. Background on the drug is on our tirzepatide index.
Every reaction reported in 2% or more of patients
Pooled from the two placebo-controlled weight trials. Figures are the percentage of each group reporting that reaction, and every one is higher than its placebo rate — that is the label’s criterion for inclusion.
| Reaction | Placebo | 5 mg | 10 mg | 15 mg |
|---|---|---|---|---|
| Nausea | 8% | 25% | 29% | 28% |
| Diarrhoea | 8% | 19% | 21% | 23% |
| Constipation | 5% | 17% | 14% | 11% |
| Vomiting | 2% | 8% | 11% | 13% |
| Abdominal pain | 5% | 9% | 9% | 10% |
| Indigestion | 4% | 9% | 9% | 10% |
| Injection site reactions | 2% | 6% | 8% | 8% |
| Fatigue | 3% | 5% | 6% | 7% |
| Hypersensitivity reactions | 3% | 5% | 5% | 5% |
| Burping | 1% | 4% | 5% | 5% |
| Hair loss | 1% | 5% | 4% | 5% |
| Acid reflux | 2% | 4% | 4% | 5% |
| Dizziness | 2% | 4% | 5% | 4% |
| Flatulence | 2% | 3% | 3% | 4% |
| Abdominal bloating | 2% | 3% | 3% | 4% |
| Low blood pressure | 0% | 1% | 1% | 2% |
Do not count the rows to compare drugs
This table lists everything reported at 2% or more. Orforglipron’s label uses a 5% threshold, so its list is shorter for a reason that has nothing to do with the drug being gentler. Comparing list lengths across labels compares reporting thresholds, not safety.
Two entries in that table only exist because this is an injection. Injection site reactions — bruising, redness, itching, pain — were reported by 6% to 8%, against 2% on placebo. That is the trade an oral option removes, and it is worth weighing against the larger weight reduction tirzepatide produces.
How many stopped, and when
| Group | Stopped because of a side effect |
|---|---|
| Placebo | 3.4% |
| 5 mg | 4.8% |
| 10 mg | 6.3% |
| 15 mg | 6.7% |
The label adds the detail that matters more than the percentages: most people who stopped did so during the first few months, because of digestive reactions. This is a front-loaded problem, not a constant one — which is consistent with reactions being worst while the dose is being increased.
The rate is not fixed across trials, either. In the trial that began with an intensive lifestyle programme, 10% of people on tirzepatide stopped because of adverse reactions against 2% on placebo — noticeably higher than the pooled figure above. Discontinuation depends on the population and the study design, not on the drug alone.
The serious warnings, including one people miss
Separate from the common reactions, the label carries ten warnings about rarer but more serious events. Most are shared across this drug class. One is not shared by all of it.
Suicidal behaviour and ideation
Zepbound’s label carries this as a distinct warning. So does liraglutide’s. Orforglipron’s does not — its warnings section has no equivalent entry. We are reporting a difference between labels, not asserting a difference in risk: a newer drug has less accumulated data behind it, and absence of a warning is not evidence of absence of an effect. If you or someone you know is struggling, this is worth raising with a prescriber rather than reading off a table.
- Thyroid C-cell tumours — the boxed warning. The label states plainly that in rats, tirzepatide causes these tumours, and that whether it does so in humans is unknown. Contraindicated for anyone with a personal or family history of medullary thyroid carcinoma, or with MEN 2.
- Pancreatitis, gallbladder disease and severe gastrointestinal reactions. Three separate warnings. Persistent severe abdominal pain is the symptom flagged for urgent attention.
- Kidney injury from dehydration. A downstream consequence of vomiting and diarrhoea rather than a direct effect, which is why fluid loss is treated as serious rather than merely unpleasant.
- Low blood sugar, hypersensitivity reactions, and diabetic retinopathy complications. The hypoglycaemia risk is materially higher for anyone also taking insulin or a sulfonylurea.
- Aspiration under anaesthesia. Because these drugs slow stomach emptying, food can remain in the stomach longer than expected. Tell anyone planning surgery or a procedure with sedation that you are taking it.
What this site will not tell you
- How to reduce or manage these reactions. That is a conversation with a prescriber who knows your history.
- Whether to lower your dose, pause, or stop. Nothing here is a reason to change a prescribed medicine without medical advice.
- Which drug in this class is best tolerated. No trial has compared them on tolerability in a way that supports ranking them, and the labels use different reporting thresholds.
- Anything about compounded tirzepatide. Concentrations vary by pharmacy, so figures from this label do not transfer to a compounded vial.
Sources and method
- Every figure on this page. The approved prescribing information for Zepbound (tirzepatide), NDA 217806, read from the FDA’s own document archive — the adverse reactions section for the table and discontinuation rates, and the warnings section for the serious events.
- The safety population. 2,519 adults with obesity or overweight treated for up to 72 weeks across two placebo-controlled trials, pooled. Mean age 47, 37% male, mean BMI 37.4, 25% with type 2 diabetes. Percentages describe that population and may not describe yours.
- On comparing labels. Different labels use different inclusion thresholds — 2% here, 5% on orforglipron. Any comparison of the lists has to account for that, and this page does not rank drugs on tolerability because the evidence does not support it.
- Method. Every percentage is reproduced with its placebo comparison, because a side-effect rate without one cannot be interpreted. Where the label reports timing or a non-monotonic pattern, that is stated rather than smoothed into a simple dose-response.
Tirzepatide index → Semaglutide side effects → Orforglipron side effects →
FDA label read 5 September 2026. We recheck this page whenever the label is revised.