Drug facts

Tirzepatide and headaches

Quick answer

Headache is not a listed adverse reaction on either tirzepatide label. It is not in Zepbound’s table of trial reactions, not among the other reactions section 6.1 describes, and not in the postmarketing list. The label gives no rate, so this page gives none. The one place the word appears is the Medication Guide, as one of the signs of low blood sugar.

What the label lists, and what it does not1

An absence is only worth reporting with the list of what was read. For the Zepbound prescribing information, revision 8/2026, that is every place a side effect can be recorded:

Table 1 (section 6.1)
Sixteen reactions reported in at least 2% of participants on Zepbound and more often than on placebo, from nausea to low blood pressure. Headache is not one of them.
The rest of 6.1
Separate paragraphs on gastrointestinal reactions, pancreatitis, low blood pressure, hypersensitivity, injection site reactions and hair loss, then “Other Adverse Reactions”: acute kidney injury, gallbladder disease, low blood sugar, heart rate increase, dysesthesia, altered taste and dry mouth, then laboratory changes in amylase and lipase. No headache.
The sleep apnea trials
Reported as similar to the obesity trials, with no separate list.
Postmarketing (section 6.2)
Gastrointestinal, hypersensitivity, pulmonary and kidney entries. No headache.
The whole document
The word “headache” does not occur anywhere in it.

The one place the word appears2

The Medication Guide, the plain-language leaflet approved alongside the label, lists headache once. It is in the section on low blood sugar (hypoglycemia), as one of twelve signs and symptoms: dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood changes, hunger, weakness and feeling jittery. The Mounjaro Medication Guide has the same list.

That is not the label saying tirzepatide causes headaches. It is the label saying a headache can be one sign of a different, listed problem.3 Section 5.7 says the drug lowers blood glucose and can cause hypoglycemia, and that the risk rises with insulin or an insulin secretagogue such as a sulfonylurea. In the diabetes trial, Study 2, glucose below 54 mg/dL was reported in 4.2% on tirzepatide against 1.3% on placebo, and in 10.3% of those also taking a sulfonylurea. Section 6.1 adds that Study 1, in people without diabetes, did not systematically capture low blood sugar. Insulin, sulfonylureas and the other interactions →

What an absence on a label means1

A reaction earns a row in Table 1 by passing two tests: at least 2% of participants on Zepbound reported it, and more of them did than on placebo. Headache’s absence tells you it did not clear that bar in the pooled trials. It does not tell you that nobody in them had a headache, and it cannot tell you whether yours is related.

Nor is the absence a rule for every drug of this kind.5 The label for Saxenda, the daily liraglutide injection, does list headache: 13.6% on the drug against 12.6% on placebo. The placebo figure is the lesson there. About one person in eight reported a headache without the drug at all, which is why a label only counts what rises above placebo. Liraglutide and tirzepatide, label by label →

What the label does count, nearby1

Table 1 does count three general symptoms. The label does not connect any of them to headache; they are shown here because they are what it records instead.

Rows from Table 1, by dose, against placebo.
ReactionPlacebo5 mg10 mg15 mg
Fatigue3%5%6%7%
Dizziness2%4%5%4%
Hypotension0%1%1%2%

The fatigue row pools asthenia, fatigue, lethargy and malaise; the hypotension row pools decreased blood pressure, hypotension and orthostatic hypotension. Of low blood pressure the label says it was more frequent in people on blood pressure medicines and “also occurred in association with gastrointestinal adverse events and dehydration.” The fatigue figures are unpacked in does tirzepatide make you tired, and dehydration in tirzepatide and diarrhea.

The Mounjaro label is the same4

Mounjaro is the same molecule, approved for type 2 diabetes and tested in different trials. Its prescribing information, revision 8/2026, does not contain the word either: not in its Table 1 of reactions in 5% or more of patients, not in its gastrointestinal or other adverse reaction paragraphs, and not in its postmarketing list. Its Medication Guide mentions headache only among the signs of low blood sugar, exactly as Zepbound’s does. Mounjaro and Zepbound compared →

What none of this covers

On the label — Mounjaro / Zepbound

The census above covers the approved product’s own trials and postmarketing reports, as the label records them.

In a compounded vial

No trial has measured side effects of a compounded preparation. Concentration and excipients differ between compounders, and the label’s silence on headache says nothing about them. What is actually different →

A headache has many causes, and a label cannot sort them. Whether a headache while taking tirzepatide needs attention is a question for the prescriber, not for this page. See the medical disclaimer, and the full list of reactions the label does report.

Questions

Does tirzepatide cause headaches?
Headache is not a listed adverse reaction on the Zepbound or Mounjaro label. It is not in the table of reactions reported in the obesity trials, not among the other adverse reactions the label describes, and not in the list of postmarketing reports. The label gives no rate for it.
Is headache a side effect of Zepbound?
The Zepbound prescribing information does not list it. The Zepbound Medication Guide mentions headache once, as one of the possible signs of low blood sugar, alongside dizziness, sweating, shakiness, hunger and others. The risk of low blood sugar is higher when tirzepatide is used with insulin or a sulfonylurea.
Is headache a side effect of Mounjaro?
The Mounjaro prescribing information does not list it either. As with Zepbound, the Mounjaro Medication Guide names headache only among the signs of low blood sugar.
If the label does not list headache, does that mean nobody in the trials had one?
No. A reaction enters the Zepbound table only if it was reported by at least 2% of participants on the drug and more often than on placebo. Headache not appearing means it did not clear that bar in the pooled trials. It does not mean no participant reported one.

Sources

  1. FDA prescribing information for ZEPBOUND (tirzepatide), sections 6.1 and 6.2, revision 8/2026 DailyMed
  2. Medication Guides for ZEPBOUND and MOUNJARO (tirzepatide), both revision 8/2026 DailyMed
  3. FDA prescribing information for ZEPBOUND (tirzepatide), section 5.7, revision 8/2026 DailyMed
  4. FDA prescribing information for MOUNJARO (tirzepatide), full text, revision 8/2026 DailyMed
  5. FDA prescribing information for SAXENDA (liraglutide), section 6.1, Table 2, revision 2/2026